UNIVERSITY OF STRATHCLYDE

Patent Trials and Appeals Board

Jul 8, 2020

IPR2019-00431 (P.T.A.B. Jul. 8, 2020)

Trials@uspto.gov Paper 38
Tel: 571-272-7822 Entered: July 8, 2020

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

CLEAR-VU LIGHTING LLC,
Petitioner,

v.

UNIVERSITY OF STRATHCLYDE,
Patent Owner.
____________

Case IPR2019-00431
Patent 9,839,706 B2
____________

Before DONNA M. PRAISS, CHRISTOPHER L. CRUMBLEY, and
JEFFREY W. ABRAHAM, Administrative Patent Judges.

ABRAHAM, Administrative Patent Judge.
JUDGMENT
Final Written Decision
Determining All Claims Unpatentable
Denying Patent Owner’s Motion to Exclude
35 U.S.C. § 318(a); 37 C.F.R. § 42.64

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I. INTRODUCTION
Clear-Vu Lighting LLC (“Petitioner”) filed a Petition (Paper 1, “Pet.”)
requesting inter partes review of claims 1–4 of U.S. Patent No. 9,839,706
B2 (Ex. 1001, “the ’706 patent”). University of Strathclyde (“Patent
Owner”) filed a Preliminary Response to the Petition (Paper 10, “Prelim.
Resp.”).
On July 10, 2019, we instituted an inter partes review of all of the
challenged claims based on all of the grounds identified in the Petition.
Paper 12 (“Inst. Dec.”). Subsequently, Patent Owner filed a Response
(Paper 16, “PO Resp.”), Petitioner filed a Reply (Paper 21) and Patent
Owner filed a Sur-reply (Paper 29). An oral hearing was held on April 21,
2020, and a transcript of the hearing has been entered into the record. Paper
37 (“Tr.”).
Patent Owner also filed a Motion to Exclude Evidence. Paper 33
(“Motion”). Petitioner filed an Opposition to Patent Owner’s Motion (Paper
34) and Patent Owner filed a Reply to Petitioner’s Opposition (Paper 36).
We have jurisdiction under 35 U.S.C. § 6. This Final Written
Decision is issued pursuant to 35 U.S.C. § 318(a). For the reasons that
follow, we determine that Petitioner has shown by a preponderance of the
evidence that claims 1–4 of the ’706 patent are unpatentable.
A. Related Proceedings
The parties state that the ’706 patent issued from U.S. Application No.
14/657,398 (“the ’398 Application”), which is a continuation of U.S.
Application No. 11/997,227 (“the ’227 Application”). Pet. 1; Paper 9, 2.
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The ’227 Application is now issued as U.S. Patent No. 9,039,966 (“the ’966
patent”), which was the subject of IPR2019-00588.1 Pet. 1; Paper 9, 2.
The parties indicate that the ’706 patent is at issue in Kenall Mfg. Co.
v. Clear-Vu Lighting LLC, 2:18-cv-01337 (E.D.N.Y). Pet. 1; Paper 9, 2.
The ’706 patent was also at issue in Kenall Mfg. Co. v. 555 Int’l, Inc.,
No. 1:17-cv-01668 (D. Del.) (voluntarily dismissed on May 14, 2018), and
Kenall Mfg. Co. v. Oldenburg Group Inc., No. 2:18-cv-01352 (E.D. Wis.)
(voluntarily dismissed on May 12, 2020). Paper 9, 2–3.
B. The ’706 Patent
The ’706 patent, titled “Inactivation of Gram-Positive Bacteria,”
issued on December 12, 2017. Ex. 1001, codes (45), (54). The ’706 patent
explains that Gram-positive bacteria, including Staphylococcus aureus and
methicillin (multi)-resistant Staphylococcus aureus (MRSA), Coagulase-
Negative Staphylococcus (CONS), Streptococcus, Enterococcus, and
Clostridium species, are known to cause health problems, such as infections,
especially in a hospital environment. Ex. 1001, 1:23–58. The ’706 patent
explains that MRSA
is becoming an increasingly problematic micro-organism, with
infection rates rising and effective methods of control becoming
more and more limited. In addition to the resistance of MRSA
to antibiotics, there is a significant problem due to the availability
of few effective sterilisation methods for environmental
decontamination; for example in air and on contact surfaces.
Public and media interest in the transmission and control of
MRSA is escalating and it is becoming one of the most
significant problems within the healthcare industry.

1 The Board denied institution of IPR2019-00588 on September 30, 2019.
Clear-Vu Lighting LLC v. University of Strathclyde, IPR2019-00588, Paper
24 (PTAB Sept. 30, 2019).
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Ex. 1001, 1:23–33. The ’706 patent discusses prior art techniques for
destroying harmful bacteria, including ones that use light energy in
combination with photosensitizing agents. Ex. 1001, 1:60–2:19. The ’706
patent characterizes these as “useful,” but “suffer[ing] from the significant
practical disadvantage that photosensitising agents must be applied to the
bacteria that are to be inactivated.” Ex. 1001, 2:10–15.
Thus, the ’706 patent is directed to a “simple and effective” technique
for inactivating bacteria comprising exposing bacteria to visible light
without using a photosensitizer. Ex. 1001, 2:20–30. According to the ’706
patent, the inventors found that exposing certain bacteria to blue light, or
white light containing blue light, stimulates an inactivation process.
Ex. 1001, 2:50–52. Using light in the visible-wavelength region is
advantageous because it has no detrimental effect on human or animal heath,
and, therefore, “can be used for an extensive range of applications, such as
air disinfection, contact-surface and materials disinfection and, most
noteworthy, wound protection and tissue disinfection.” Ex. 1001, 2:52–57.
C. Illustrative Claim
Petitioner challenges claims 1–4 of the ’706 patent. Independent
claim 1 is illustrative of the challenged claims and is reproduced below:
1. A method for disinfecting air, contact surfaces or
materials by inactivating one or more pathogenic Gram-positive
bacteria in the air, on the contact surfaces or on the materials,
said method comprising exposing the one or more pathogenic
Gram-positive bacteria to visible light without using a
photosensitizer, wherein the one or more pathogenic Gram-
positive bacteria are selected from the group consisting of
Methicillin-resistant Staphylococcus aureus (MRSA),
Coagulase-Negative Staphylococcus (CONS), Streptococcus,
Enterococcus, and Clostridium species, and wherein a portion
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of the visible light that inactivates the one or more pathogenic
Gram-positive bacteria consists of wavelengths in the range
400-420 nm, and wherein the method is performed outside of
the human body and the contact surfaces or the materials are
non-living.
Ex. 1001, 7:17–8:5.
D. Reviewed Grounds of Unpatentability
Claims Challenged 35 U.S.C. § Reference(s)
1, 3 102 Nitzan2
2, 4 103 Nitzan, Jones3
1, 3 103 Ashkenazi,4 Nitzan
2, 4 103 Ashkenazi, Nitzan, Jones

E. Level of Ordinary Skill in the Art
Petitioner contends that a person of ordinary skill in the art “would
have had at least a bachelor of science degree in one of the areas of
molecular biology, biochemistry, microbiology, or infectious diseases, and
likely a doctoral degree in one of these subjects, with several to many years
of experience with bacterial inactivation techniques.” Pet. 18 (citing

2 Yeshayahu Nitzan et al., ALA induced photodynamic effects on Gram
positive and negative bacteria, J. PHOTOCHEM. PHOTOBIOL. SCI., 3 (2004),
430–435 (Ex. 1009).
3 Jones et al., US 2005/00550070 A1, published Mar. 10, 2005 (Ex. 1007).
4 Helena Ashkenazi et al., Eradication of Propionibacterium acnes by its
endogenic porphyrins after illumination with high intensity blue light, J.
FEMS IMMUNOLOGY AND MEDICAL MICROBIOLOGY, 35 (2003), 17–24
(Ex. 1010).
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Ex. 10235 ¶¶ 68–76). Patent Owner does not address the definition of a
person of ordinary skill in the art in its Response or Sur-reply, but Patent
Owner’s declarant, Raymond Goodrich, Ph.D., testified that a person of
ordinary skill in the art “would have had a combination of experience and
education in chemistry, photochemistry, biochemistry, bacteriology,
microbiology and/or infectious disease” including “at least a bachelor degree
of science degree in one or more of these areas and at least two years of
work experience in at least one of these fields.” Ex. 20016 ¶ 23. Dr.
Goodrich also indicated that all of his opinions would apply equally under
Petitioner’s definition of a person of ordinary skill in the art. Ex. 2001 ¶ 24.
In view of the large degree of overlap between the parties’ definitions,
and Dr. Goodrich’s statement that his opinions would apply under either
definition, we adopt Petitioner’s proposed definition, such that a person of
ordinary skill in the art would have had “at least a bachelor of science degree
in one of the areas of molecular biology, biochemistry, microbiology, or
infectious diseases, and likely a doctoral degree in one of these subjects,
with several to many years of experience with bacterial inactivation
techniques.” Pet. 18. This level of skill is consistent with the field of
endeavor of the ’706 patent and the disclosures of the asserted prior art. See
Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001); In re GPAC
Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); see also PO Resp. 36 (noting that
Dr. Sulzinski based his definition of the level of ordinary skill on the

5 Declaration of Michael A. Sulzinski, Ph.D. in Support of Petitioner Clear-
Vu Lighting LLC’s Petition for Inter Partes Review of U.S. Patent
9,839,706 (“Sulzinski Declaration”).
6 Declaration of Dr. Raymond P Goodrich (“Goodrich Declaration).
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experience level of the authors of Nitzan); Ex. 1023 ¶¶ 71–72 (discussing
the experience level of the authors of Nitzan and Ashkenazi in assessing the
level of ordinary skill in the art).
II. ANALYSIS
A. Claim Construction
In an inter partes review we construe claim terms according to the
standard set forth in Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed.
Cir. 2005) (en banc). 37 C.F.R. § 42.100(b) (2019). Under Phillips, claim
terms are afforded “their ordinary and customary meaning.” Phillips, 415
F.3d at 1312. “[T]he ordinary and customary meaning of a claim term is the
meaning that the term would have to a person of ordinary skill in the art in
question at the time of the invention.” Id. at 1313. “Importantly, the person
of ordinary skill in the art is deemed to read the claim term not only in the
context of the particular claim in which the disputed term appears, but in the
context of the entire patent, including the specification.” Id. It is also
important to consider the prosecution history, as it “can often inform the
meaning of the claim language by demonstrating how the inventor
understood the invention.” Id. at 1317. Additionally, extrinsic evidence,
particularly dictionaries and treatises, can be useful for purposes of claim
construction, but is “less significant” than intrinsic evidence. Id. at 1317–
1318 (quoting C.R. Bard, Inc. v. U.S. Surgical Corp., 388 F.3d 858, 862
(Fed. Cir. 2004)).
Petitioner proposes constructions for three terms, “inactivating,”
“photosensitizer,” and “without using a photosensitizer.” Pet. 9–16.
Petitioner also addresses the preamble of independent claims 1 and 3, as well
as means-plus-function language in claim 3. Pet. 16–18. In its Preliminary
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Response, Patent Owner proposed its own construction of the terms
“photosensitizer” and “without using a photosensitizer.” Prelim. Resp. 10–
28. In our Institution Decision, we construed the term “photosensitizer” to
mean “a substance that, when applied to a target substance, makes the target
substance more sensitive to light,” as proposed by Patent Owner. Inst. Dec.
6–13. In its Response, Patent Owner provides the same arguments it
presented in its Preliminary Response and argues that we should reaffirm our
construction of “photosensitizer.” PO Resp. 9–25. Petitioner asserts that we
should reconsider our provisional adoption of Patent Owner’s proposed
construction of this term. Reply 21–24.
After reviewing the parties’ arguments and evidence developed during
the entire course of this proceeding, we determine that only one term of the
’706 patent, “photosensitizer,” requires express construction for purposes of
this Final Written Decision. See Nidec Motor Corp. v. Zhongshan Broad
Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (citing Vivid Techs.,
Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly
those terms need be construed that are in controversy, and only to the extent
necessary to resolve the controversy.”)). We address the parties’
construction of “photosensitizer” below.
“photosensitizer”
Independent claims 1 and 3 require exposing bacteria to visible light
“without using a photosensitizer.” Ex. 1001 7:20–22, 8:12–13. Petitioner
contends a photosensitizer is “a light-reactive substance that, when exposed
to light, initiates a change in another substance.” Pet. 10 (citing Ex. 1023
¶¶ 79, 84–85). Petitioner contends that “[t]his construction is consistent
with the ’706 Patent’s statements about the use of photosensitizers in the
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prior art methods of bacterial inactivation.” Pet. 10 (citing Ex. 1001, 1:59–
2:19; Ex. 1023 ¶ 89). In particular, Petitioner notes that the ’706 patent
discusses two prior art documents, Biel7 and Albrecht8, that use light-
sensitive dyes to inactivate bacteria. Pet. 10. According to Petitioner, the
dyes in Biel and Albrecht are activated by exposing them to visible light,
causing them to produce reactive oxygen species and free radicals that lead
to the destruction of bacteria. Pet. 10–11 (citing Ex. 1001, 1:67–2:6, 2:15–
17; Ex. 1011, Abstract, 1:14–24, 4:47–53; Ex. 1012 ¶¶ 10, 16, 24).
Petitioner argues that other language in the ’706 patent specification
supports its construction of photosensitizer as a light reactive substance,
specifically the patent’s discussion of the “combined use of light and
photosensitizers to inactivate bacteria.” Reply 22 (citing Ex. 1001, 1:64,
2:1–2, 2:16–17; Ex. 10339 ¶ 80). Petitioner contends that the use of this
language “shows that the key feature of the substance used for
photodynamic treatment is its reaction when exposed to light.” Reply 22
(citing Ex. 1001, 1:59–2:19; Ex. 1033, ¶ 80).
Petitioner also argues that its construction is consistent with
statements about photosensitizers Patent Owner made during prosecution of
the application leading to the ’966 patent, which is the parent of the ’706
patent. Pet. 11 (citing Ex. 1006, 269); Reply 22 (citing Ex. 1006, 67, 104–
105, 269). In particular, Petitioner directs us to a statement in which Patent
Owner identified fullerene compounds, which generate singlet oxygen that

7 US 6,251,127 B1, issued June 26, 2001 (Ex. 1011).
8 US 2005/0049228 A1, published March 3, 2005 (Ex. 1012).
9 Declaration of Michael A. Sulzinski, Ph.D. in Support of Petitioner’s Reply
to Patent Owner’s Response (“Sulzinski Reply Declaration”).
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induces bacterial cell death when irradiated with visible light, as
photosensitizers. Pet. 11 (citing Ex. 1006, 269); Pet. 22 (citing Ex. 1006,
269).
Additionally, Petitioner presents extrinsic evidence to support its
construction, including a technical dictionary that defines photosensitizer as
“[a] light-absorbing substance that initiates a photochemical or
photophysical reaction in another substance (molecule), and is not consumed
in the reaction.” Pet. 12 (quoting Ex. 1014, 3); see also Reply 23 (noting
that one technical definition of photosensitizer refers to the combined use of
light and a photosensitizer (quoting Ex. 1037, 4)). Additionally, Petitioner
argues that “[c]ontemporaneous scientific and technical literature also show
that the physics and chemistry behind the activation of photosensitizers was
well-understood” and includes the absorption of light and transfer of energy.
Pet. 12 (citing Ex. 1016, 2, 5–7). Petitioner also directs us to an instance
wherein Patent Owner’s own declarant identified a photosensitizer as a light-
reactive substance. Reply 23 (citing Ex. 1039, 1:29–32; Ex. 2004, 6 n.3).
Patent Owner contends “photosensitizer” should be given its plain and
ordinary meaning, which is “a substance that, when applied to a target
substance, makes the target substance more sensitive to light.” PO Resp.
12–13 (emphasis omitted). Patent Owner asserts Petitioner’s proposed
construction improperly excludes well-known photosensitizers such as
ALA,10 arguing that the claims do not qualify the word photosensitizer in

10 ALA is δ-aminolevulinic acid. Ex. 1023 ¶ 30. It is undisputed that ALA
is not light reactive. Rather, ALA stimulates production of endogenous
porphyrins, which themselves react with light. Pet. 26; Ex. 1023 ¶ 137; PO
Resp. 11; Ex. 2024 ¶ 34.
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any way, and the Specification does not limit the definition of
photosensitizer to any particular type or group, or based on how it operates
on a molecular level. PO Resp. 11, 14. Instead, Patent Owner contends that
the inventors of the ’706 patent were “focused on solving the practical
disadvantages of using photosensitizers to inactivate bacteria outside of the
human body—disadvantages common to both ALA and other
photosensitizers.” PO Resp. 11 (citing Ex. 1001, 2:10–24; Ex. 2024 ¶¶ 35–
36). Patent Owner further argues that statements made by the Examiner
during prosecution of the application leading to the ’706 patent support its
interpretation of photosensitizer. PO Resp. 15–19.
Patent Owner also presents its own dictionary definition of
photosensitizer from Merriam-Webster’s Collegiate Dictionary, which is a
“substance that makes another substance ‘sensitive to the influence of
radiant energy and especially light.’” PO Resp. 22–23 (citing Ex. 2005, 3).
Patent Owner cites to several technical references that refer to certain
materials (such as ALA) as photosensitizers, consistent with this definition
and Patent Owner’s proposed construction of the term. PO Resp. 19–22
(citing Exs. 2006–2016).
Based on our review of the totality of the record after trial, we adopt
Patent Owner’s proposed construction, and construe “photosensitizer” to
mean “a substance that, when applied a target substance, makes the target
substance more sensitive to light.” 11 PO Resp. 12. Patent Owner’s

11 Petitioner argues that it is not necessary to require that a photosensitizer be
“applied” as stated in Patent Owner’s construction. Reply 21. This
distinction is not relevant to the primary dispute between the parties on this
issue, namely whether photosensitizer is limited to only light-reactive
substances. The use of the term “applied” reflects the parties’ agreement
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proposed construction of a photosensitizer as a substance that makes a target
substance more sensitive to light accords with the plain and ordinary
meaning of the term in the context of the claims and specification of the
’706 patent, whereas Petitioner’s proposed construction is unduly narrow.
Although a photosensitizer may be “a light-reactive substance that, when
exposed to light, initiates a change in another substance,” as Petitioner
proposes, we are not persuaded that the claim term should be limited to only
this specific type of photosensitizer.
Neither the claims nor the specification expressly qualify or otherwise
limit the word “photosensitizer” in any way. The Specification includes a
discussion of two prior art references (Biel and Albrecht) that apply light-
reactive dyes as photosensitizers, and states that the methodologies used in
these references “suffer[] from the significant practical disadvantage that
photosensitising agents must be applied to the bacteria that are to be
inactivated.” Ex. 1001, 2:10–15. According to the ’706 patent, “[t]he need
for photosensitising agents is a significant limitation of these techniques.”
Ex. 1001, 2:17–19. We agree with Patent Owner that these statements in the
’706 patent specification refer to the “practical disadvantage” of applying
photosensitizers in general, which is an inherent disadvantage in any
photosensitizer applied before inactivation. See PO Resp. 11, 14–15. We
are not persuaded by Petitioner’s argument that the ’706 patent was referring

that the scope of the entire claim, based on the term “without a
photosensitizer,” means without using exogenous photosensitizers, i.e.,
photosensitizers that do not naturally originate within an organism. Pet. 10,
12–13; Ex. 1033 ¶ 86. This is consistent with the discussion of “practical
disadvantage[s]” of photosensitizers that “must be applied to the bacteria
that are to be inactivated.” Ex. 1001, 2:10–15.
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only to the “practical disadvantage” associated with applying light-reactive
substances because the dyes used in Biel and Albrecht are light-reactive.
Pet. 10–11. The ’706 patent specification clearly indicates that Biel and
Albrecht describe examples of the “[m]any techniques [that] have been
proposed for destroying harmful bacteria, such as MRSA.” Ex. 1001, 1:59–
60.
Consistent with the lack of any limitations on photosensitizers in the
’706 patent specification, other evidence in the record demonstrates that a
person of ordinary skill in the art would have understood these “many
techniques” to include not only the use of light-reactive substances as
disclosed in Biel and Albrecht, but also the use of non-light-reactive
substances to destroy harmful bacteria. For example, Patent Owner directs
us to several references characterizing ALA as a photosensitizer. PO Resp.
20–21 (citing Exs. 2006–2016). As noted above, ALA is not light-reactive.
Pet. 26; Ex. 1023 ¶ 137; PO Resp. 11; Ex. 2024 ¶ 34. Thus, the
characterization of ALA as a photosensitizer in the extrinsic references
provided by Patent Owner is informative as to what the ordinary and
customary meaning of photosensitizer would have been to a person of
ordinary skill in the art, and weighs against Petitioner’s assertion that a
person of ordinary skill in the art would understand “photosensitizer” as
used in the ’706 patent to include only light-reactive substances.
We are not persuaded by Petitioner’s argument that the exhibits that
refer to ALA as a “photosensitizer” use the term “in a loose manner for the
expedience of summarizing the studies they describe,” and “go on to explain
that the photodynamic effect is due to the combination of light and a light-
reactive substance.” Reply 24. Even if Petitioner had provided sufficient
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evidence demonstrating that the authors did indeed use the term
photosensitizer in a “loose manner,” which Petitioner has not done, these
articles would nevertheless demonstrate that persons of ordinary skill in the
used the term photosensitizer to encompass both light-reactive and non-light
reactive substances. Not only does this undermine Petitioner’s arguments,
but it further supports Patent Owner’s construction of the term
photosensitizer.
With regard to Petitioner’s argument that the ’706 patent “emphasizes
the combined use of light and photosensitizers to inactivate bacteria” (Reply
22), we note that the language referring to the combination of light and a
photosensitizer in the ’706 patent specification applies equally to light-
reactive substances and non-light-reactive substances, since both types of
photosensitizers require light in combination with the photosensitizer itself
in order to inactivate bacteria. See, e.g., Ex. 1033 ¶ 88 (explaining that
exposing light reactive dyes causes the dye to produce reactive oxygen
species and free radicals which destroy bacteria); Ex. 2024 ¶ 34 (explaining
that ALA functions by being absorbed by bacteria causing production of
excess porphyrins which react with light in order to kill the bacteria).
Further, Petitioner has not directed us to evidence in the ’706 patent
specification suggesting the “combined” language applies only to light-
reactive substances. As a result, we are not persuaded by Petitioner’s
argument that the language discussing combining light with a
photosensitizer is evidence that the discussion of the “practical
disadvantages” in the ’706 patent refers only to light-reactive substances.
Nor are we persuaded by Petitioner’s argument that Patent Owner’s
statements during prosecution of the ’966 patent support its narrow
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construction. Pet. 11–12. Petitioner’s evidence consists of Patent Owner
identifying fullerene as a photosensitizer, and explaining that when fullerene
is irradiated with light it generates singlet oxygen that induces bacterial cell
death, i.e., that it is light-sensitive. Pet. 11–12; Ex. 1006, 269. Patent
Owner’s arguments here, however, are entirely consistent with its proposed
construction, which includes both light-reactive substances and non-light
reactive substances. The fact that Patent Owner argued during prosecution
that “photosensitizer” includes light reactive substances does not mean it
excludes non-light-reactive substances, and Petitioner has not provided
adequate evidence to support such a conclusion.
As to the dictionary definitions presented by the parties, each party
presents a dictionary definition that supports its own proposed construction,
something that is not uncommon. In Phillips, the Federal Circuit recognized
that “different dictionaries may contain somewhat different sets of
definitions for the same words,” and cautioned that “[a] claim should not rise
or fall based upon the preferences of a particular dictionary editor, or the
court’s independent decision, uninformed by the specification, to rely on one
dictionary rather than another.” Phillips, 415 F.3d at 1322. Rather,
dictionary definitions should be considered in the context of the
specification, claims, and prosecution history, and reliance on dictionary
definitions is proper “so long as the dictionary definition does not contradict
any definition found in or ascertained by a reading of the patent documents.”
Id. at 1322–23 (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576,
1584 n.6 (Fed. Cir. 1996)).
Petitioner’s dictionary definition, “[a] light-absorbing substance that
initiates a photochemical or photophysical reaction in another substance
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(molecule), and is not consumed in the reaction,” restricts photosensitizers to
light absorbing substances. Pet. 12; Ex. 1014, 3. As discussed above, based
on our review of the ’706 patent’s claims, specification, and prosecution
history, we discern no basis for restricting the meaning of photosensitizer as
proposed by Petitioner. To the contrary, Patent Owner’s dictionary
definition of photosensitizer, a “substance that makes another substance
‘sensitive to the influence of radiant energy and especially light’” (PO Resp.
22–23; Ex. 2005, 3), is more inclusive, and thus most naturally aligns with
the patent’s description of the invention.
Petitioner argues that Patent Owner’s “only definition from a non-
technical dictionary cannot outweigh those in the technical dictionaries and
references that align with the patent’s discussion of photosensitizers in the
context of combing light and light-reactive substances.” Reply 23–24. As
discussed above, however, the definitions in Petitioner’s technical
dictionaries do not align with the discussion of photosensitizers in the ’706
patent specification. Petitioner also contends that Dr. Goodrich, Patent
Owner’s declarant, has defined photosensitizer as “compounds which absorb
light of a defined wavelength and transfer the absorbed energy to an energy
acceptor,” i.e., light-reactive substances. Reply 23 (citing Ex. 1039,12 1:29–
32). The fact that Dr. Sulzinski defines a photosensitizer as a light-reactive
substance in a different patent, in which he is entitled to act as his own
lexicographer, is not highly relevant to how the inventors of an entirely
different patent used that term, nor is it entirely inconsistent with Patent
Owner’s proposed construction, which includes both light-reactive and non-

12 US Patent No. 6,258,577 B1, issued July 10, 2001.
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light reactive substances. See Phillips, 415 F.3d at 1315 (holding that a
patent’s specification is “the single best guide to the meaning of a disputed
term.”)
In view of the foregoing reasons, we construe “photosensitizer” to
mean “a substance that, when applied to a target substance, makes the target
substance more sensitive to light.”
B. Legal Principles
1. Burden of Proving Unpatentability
In an inter partes review, the petitioner bears the burden of proving
unpatentability of the challenged claims, and the burden of persuasion never
shifts to the patent owner. Dynamic Drinkware, LLC v. Nat’l Graphics, Inc.,
800 F.3d 1375, 1378 (Fed. Cir. 2015). To prevail in this proceeding,
Petitioner must support its challenges by a preponderance of the evidence.
35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d). Accordingly, all of our findings
and conclusions are based on a preponderance of the evidence.
2. Anticipation
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros. Inc., v. Union Oil Co., 814 F.2d 628, 631
(Fed. Cir. 1987). Moreover, “[b]ecause the hallmark of anticipation is prior
invention, the prior art reference—in order to anticipate under 35 U.S.C.
§ 102—must not only disclose all elements of the claim within the four
corners of the document, but must also disclose those elements ‘arranged as
in the claim.’” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369
(Fed. Cir. 2008). Whether a reference anticipates is assessed from the
perspective of an ordinarily skilled artisan. See Dayco Prods., Inc. v. Total
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Containment, Inc., 329 F.3d 1358, 1368 (Fed. Cir. 2003) (“[T]he dispositive
question regarding anticipation [i]s whether one skilled in the art would
reasonably understand or infer from the [prior art reference’s] teaching that
every claim element was disclosed in that single reference.”). In that regard,
in an anticipation analysis, “it is proper to take into account not only specific
teachings of the reference but also the inferences which one skilled in the art
would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d
825, 826–27 (CCPA 1968). Furthermore, “[i]t is well settled that the
recitation of a new intended use for an old product does not make a claim to
that old product patentable.” In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir.
1997).
3. Obviousness
In Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966), the
Supreme Court set out a framework for assessing obviousness under § 103
that requires consideration of four factors: (1) the “level of ordinary skill in
the pertinent art,” (2) the “scope and content of the prior art,” (3) the
“differences between the prior art and the claims at issue,” and
(4) “secondary considerations” of non-obviousness such as “commercial
success, long-felt but unsolved needs, failure of others, etc.” Id. at 17–18.
“While the sequence of these questions might be reordered in any particular
case,” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 407 (2007), the Federal
Circuit has “repeatedly emphasized that an obviousness inquiry requires
examination of all four Graham factors and that an obviousness
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determination can be made only after consideration of each factor.” Nike,
Inc. v. Adidas AG, 812 F.3d 1326, 1335 (Fed. Cir. 2016).
“[A] a patent composed of several elements is not proved obvious
merely by demonstrating that each of its elements was, independently,
known in the prior art.” KSR, 550 U.S. at 418. Rather, “it can be important
to identify a reason that would have prompted a person of ordinary skill in
the relevant field to combine the elements in the way the claimed new
invention does.” Id. Furthermore, a party seeking to demonstrate that a
patent would have been obvious must show that “a skilled artisan would
have been motivated to combine the teachings of the prior art references to
achieve the claimed invention, and that the skilled artisan would have had a
reasonable expectation of success in doing so.” Kinetic Concepts, Inc. v.
Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012) (quoting
Procter & Gamble Co. v. Teva Pharm. USA, Inc., 566 F.3d 989, 994 (Fed.
Cir. 2009)). Ultimately, “there must be some articulated reasoning with
some rational underpinning to support the legal conclusion of obviousness.”
In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (cited with approval in KSR,
550 U.S. at 418).
C. Overview of Asserted References
1. Nitzan (Ex. 1009)
Nitzan is directed to the photodynamic inactivation of bacteria by
endogenously produced porphyrins after incubation with ALA. Ex. 1009,
430. Nitzan discloses experiments involving growing bacterial strains
(including MRSA), incubating the bacteria with ALA, exposing the bacteria
to blue light between 407 and 420 nm, and monitoring the survival of
bacterial cells following photosensitization. Ex. 1009, 430–431. Nitzan
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explains that bacterial cultures grown under the same conditions and light
exposure, but without ALA, served as controls. Ex. 1009, 431. The survival
fraction of bacterial cells after exposure to light was calculated according to
the equation N/N0, where N0 is the number of colony forming units
(“CFUs”) at zero time, and N is the number of colony forming units after
illumination. Ex. 1009, 431.
Table 2 of Nitzan shows the survival fractions of “photosensitized
bacterial cultures” after illumination with blue light at a light dose of 50
J/cm2 and 100 J/cm2. Ex. 1009, 432. The results show a decrease of five
orders of magnitude upon illumination of ALA-induced S. aureus with a
light dose of 50 J/cm2 and “almost total eradication” with a 100 J/cm2 dose.
Ex. 1009, 430, 432.
Table 5 of Nitzan compares survival fractions of bacterial cultures
incubated with and without ALA. Ex. 1009, 433. Nitzan reports that for
bacterial strains that were not incubated with ALA, no decrease in viability
was observed after illumination with a dose of 50 J/cm2. Ex. 1009, 433.
2. Ashkenazi (Ex. 1010)
Ashkenazi investigated the eradication of Propionibacterium acnes
(P. acnes) after illumination with intense blue light at 407–420 nm.
Ex. 1010, 17 (Abstract). Ashkenazi tested the viability of P. acnes both with
and without the addition of ALA, and reported the following:
The viability of 24 h cultures grown anaerobically in liquid
medium was reduced by less than two orders of magnitude when
illuminated once with a light dose of 75 J cm-2. Better
photodynamic effects were obtained when cultures were
illuminated twice or three times consecutively with a light dose
of 75 J cm-2 and an interval of 24 h between illuminations. The
viability of the culture under these conditions decreased by four
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orders of magnitude after two illuminations and by five orders of
magnitude after three illuminations. When ALA-triggered
cultures were illuminated with intense blue light at a light dose
of 75 J cm-2 the viability of the treated cultures decreased by
seven orders of magnitude.
Ex. 1010, 17. Based on these results, Ashkenazi concluded that “[a]
treatment protocol with a series of several illuminations or illumination after
application of ALA may be suitable for curing acne.” Ex. 1010, 17.
3. Jones (Ex. 1007)
Jones relates to a method and apparatus for the treatment of a skin
condition, in particular Acne Vulgaris, involving directing light radiation
onto a region of skin affected by Acne Vulgaris. Ex. 1007 ¶¶ 2, 12. Jones
explains that upon exposure to light, “a photo-chemical reaction is caused
that disables or destroys, wholly or partially, the bacteria Propionibacterium
acnes, which, as described above, is one of the causes of Acne Vulgaris.”
Ex. 1007 ¶ 23. According to Jones, the photo-chemical reaction is a result
of a substance within the skin absorbing radiation within a range of
particular wavelengths and producing free radicals which may destroy the
bacteria. Ex. 1007 ¶ 24. Jones explains that for its invention, porphyrin, a
naturally occurring substance produced by P. acnes, is the targeted
substance, and produces free radicals (in the form of oxygen singlets) “when
excited by light of a wavelength of around 405 nm.” Ex. 1007 ¶ 24; see also
Ex. 1007 ¶ 29 (“The illuminating radiation may include radiation
substantially concentrated around the wavelength of violet/near ultra-violet
light (405 nm).”).
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D. Claims 1 and 3 – Alleged Anticipation by Nitzan
Petitioner contends claims 1 and 3 are unpatentable as anticipated by
Nitzan. Pet. 24–39.
Claims 1 and 3 each require exposing bacteria to visible light “without
using a photosensitizer.” Ex. 1001, 7:20–22, 8:12–13. As discussed above,
Nitzan studied the photodynamic inactivation of bacteria after incubation
with ALA. Ex. 1009, 430. In the Petition, Petitioner contends that Nitzan
discloses the “without using a photosensitizer” limitation because ALA is
not a photosensitizer under Petitioner’s proposed construction of the term.
Pet. 26 (arguing that “ALA is not a light-reactive substance that initiates a
change in another substance when it is exposed to visible light”), 38–39. For
the reasons discussed above, however, we do not adopt Petitioner’s
construction of the term photosensitizer.
Instead, the proper construction of photosensitizer is “a substance that,
when applied to or present within a target substance, makes the target
substance more sensitive to light.” Patent Owner argues that “ALA has been
used for many years to make bacteria and other substances more sensitive to
light,” and “was widely regarded in the art as a photosensitizer at the time of
the invention.” PO Resp. 19–21 (citing Ex. 2024 ¶¶ 46–58; Exs. 2006–
2016).
We agree that ALA is a photosensitizer under the proper construction
of that term. It is undisputed that upon exposure to bacteria, ALA causes the
production of excess porphyrins within the bacteria, which react with light in
order to kill the bacteria. Pet. 26; Ex. 1023 ¶ 137; PO Resp. 11; Ex. 2024
¶ 34. Accordingly, ALA is a substance that, when applied to bacteria,
makes the bacteria more sensitive to light. Additionally, based on evidence
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presented by Patent Owner, we agree that ALA was regarded in the art as a
photosensitizer. See, e.g., Ex. 2006, 158 (“This review focuses on the
development of ALA as a photosensitizer in photodynamic therapy and
photodiagnosis, and the wide range of clinical applications in which ALA is
now being used as a therapeutic modality.” ) (emphasis added).
Petitioner relies on the data presented in Table 2 of Nitzan to
demonstrate Nitzan found that MRSA could be inactivated when illuminated
with 407–420 nm light. Pet. 24 (citing Ex. 1009, 432, Table 2). It is
undisputed that Nitzan introduced ALA to the bacteria studied in Table 2
prior to exposing the bacteria to visible light. Pet. 24, 31; Ex. 1009, 431–32.
Other than arguing ALA is not a photosensitizer, Petitioner does not present
any arguments or evidence in the Petition demonstrating how or why Nitzan
satisfies the “without a photosensitizer” limitation. Pet. 26, 31, 33–35.
In its Reply, Petitioner argues that Nitzan anticipates the independent
claims under a construction of photosensitizer that includes ALA. Reply 25.
First, Petitioner argues that Nitzan washed the ALA-induced MRSA sample
with PBS and transferred the sample to a sterile dish prior to exposing it to
blue light. Reply 25 (citing Ex. 1009, 431). According to Petitioner, “[t]he
ALA-incubated MRSA thus would have been rinsed of any ALA present in
its incubation media,” and, therefore Nitzan meets the “exposing . . . without
using a photosensitizer” limitation “[b]ecause no ALA would have been
present during the PBS-washed MRSA’s exposure to blue light.” Reply 25
(citing Ex. 1033 ¶ 77).
We are not persuaded by Petitioner’s argument. Although Petitioner
cites to a paragraph in the Sulzinski Reply Declaration to support the
argument that the MRSA would have been rinsed of any ALA, Dr. Sulzinski
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merely states that this is his opinion, and offers no evidence to support that
statement. Ex. 1033 ¶ 77. Without disclosing the underlying facts or data
forming the basis for this opinion, this testimony is entitled to little or no
weight. 37 C.F.R. § 42.65(a). Additionally, even if we were to agree that all
of the MRSA would have been rinsed of any ALA prior to exposing it to
light, the outcome here would not change because Nitzan used a
photosensitizer when it incubated the MRSA in ALA. The fact that Nitzan
later rinsed the MRSA does not change the fact that Nitzan used a
photosensitizer as part of its method, as precluded by claims 1 and 3.
Petitioner also argues that the MRSA exposed to blue light in the
absence of ALA and extracellular porphyrins in Nitzan showed a 1.0
survival fraction, which meant that the number of colony forming units
before and after light exposure was the same. Reply 25–26. According to
Petitioner, this demonstrates inactivation, as that term is defined in the ’706
patent. Pet. 26. Dr. Sulzinski testifies that a person of ordinary skill in the
art would have expected the bacterial population in Nitzan’s non-ALA-
treated sample to increase during the four-hour incubation period used in
Nitzan’s method, leading to the conclusion that the 1.0 survival fraction
indicates that the light exposure inhibited the growth of the bacterial
population. Ex. 1033 ¶¶ 62–63.
Petitioner’s argument is not persuasive because it is based on the
assumption that the bacterial population of Nitzan’s non-ALA-treated
MRSA would have increased between the two CFU measurements taken to
determine the survival fraction. Petitioner, however, does not present
evidence indicating how much time elapsed between the two CFU
measurements or the growth rate of the sample tested, which undermines
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Petitioner’s argument that a person of ordinary skill in the art would have
expected the bacterial population to increase between the two CFU
measurements. As a result, Petitioner has not demonstrated by a
preponderance of evidence that a 1.0 survival fraction measured for Nitzan’s
non-ALA induced MRSA demonstrates “inactivation,” as claims 1 and 3
require.
For all of the foregoing reasons, we find that Petitioner has failed to
demonstrate by a preponderance of evidence that Nitzan discloses all
elements of independent claims 1 and 3. Accordingly, based on the present
record, we find Petitioner has failed to establish by a preponderance of
evidence that claims 1 and 3 are unpatentable as anticipated by Nitzan.
E. Claims 2 and 4 – Alleged Obviousness in view of Nitzan and Jones
Claims 2 and 4 depend from claims 1 and 3, respectively. Petitioner
does not rely on Jones to cure the aforementioned deficiencies in its
argument that Nitzan anticipates independent claims 1 and 3. See Pet. 40–
44. As a result, for the reasons discussed above, we reach the same
conclusion here as we did for Petitioner’s challenge that claims 1 and 3 are
anticipated by Nitzan, and find that Petitioner has failed to establish by a
preponderance of evidence that claims 2 and 4 are unpatentable as obvious
over Nitzan and Jones.
F. Claims 1 and 3 – Alleged Obviousness in view of Ashkenazi and
Nitzan
Petitioner argues the subject matter of claims 1 and 3 would have been
obvious in view of the combined disclosures of Ashkenazi and Nitzan.
Pet. 44–65. Petitioner directs us to portions of Ashkenazi and Nitzan that
purportedly teach or suggest all the limitations in claims 1 and 3, arguing
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that a person of ordinary skill in the art would have found it obvious to
combine the teachings of Ashkenazi and Nitzan to arrive at the claimed
invention, and would have had a reasonable expectation of successfully
doing so. Pet. 44–65.
In its Response, Patent Owner argues that the combined disclosures of
Ashkenazi and Nitzan fail to teach or suggest inactivating MRSA “without
using a photosensitizer.” PO Resp. 58–61. Patent Owner also contends that
Petitioner failed to establish: (1) that a person of ordinary skill in the art
would have been motivated to combine the teachings of Ashkenazi and
Nitzan; and (2) that the skilled artisan would have had a reasonable
expectation of success. PO Resp. 30–58. We address these arguments in
turn, below.
1. Whether Ashkenazi and Nitzan Teach or Suggest All Limitations of
Claims 1 and 3
Claim 1 recites “[a] method for disinfecting air, contact surfaces or
materials by inactivating one or more pathogenic Gram-positive bacteria in
the air, on the contact surfaces or on the materials,” wherein “the one or
more pathogenic Gram-positive bacteria are selected from the group
consisting of Methicillin-resistant Staphylococcus aureus (MRSA),
Coagulase-Negative Staphylococcus (CONS), Streptococcus, Enterococcus,
and Clostridium species.” Ex. 1001, 7:17–26.
Petitioner argues that Ashkenazi discloses a study using visible light
to inactivate P. acnes, a Gram-positive bacteria, distributed into test tubes.
Pet. 44, 55 (citing Ex. 1010, 18). Petitioner contends that the test tubes in
Ashkenazi correspond to the “materials” or “contact surfaces” recited in
claim 1. Pet. 44, 55. Petitioner acknowledges that Ashkenazi does not
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explicitly recite inactivating one of the claimed species of Gram-positive
bacteria, but argues that Nitzan does, because Nitzan inactivated MRSA by
exposing it to blue light, and MRSA is one of the claimed species of Gram-
positive bacteria. Pet. 60. Petitioner thus contends that Ashkenazi and
Nitzan disclose the claimed step of “disinfecting air, contact surfaces or
materials by inactivating one or more pathogenic Gram-positive bacteria in
the air, on the contact surfaces or on the materials” as well as the
requirement in claim 1 that “the one or more pathogenic Gram-positive
bacteria are selected from the group consisting of Methicillin-resistant
Staphylococcus aureus (MRSA), Coagulase-Negative Staphylococcus
(CONS), Streptococcus, Enterococcus, and Clostridium species.” Pet. 55–
58, 60–62.
Claim 1 further requires “exposing the one or more pathogenic Gram-
positive bacteria to visible light without using a photosensitizer.” Ex. 1001,
7:20–22. Petitioner asserts that Ashkenazi teaches exposing P. acnes to blue
light, which is within the visible spectrum, without applying ALA to the
bacteria. Pet. 59. According to Petitioner, “[a]pplying Ashkenazi’s
techniques to MRSA would have yielded MRSA grown in the absence of
exogenous ALA. (Ex. 1023, ¶ 190.) And that MRSA would have been
exposed to visible blue light.” Pet. 59. Petitioner thus argues that
Ashkenazi in view of Nitzan discloses this limitation.
Petitioner also directs us to Ashkenazi’s disclosure of using blue light
having a wavelength of 407–420 nm to inactivate bacteria. Pet. 62 (citing
Ex. 1010, 18). In view of this, Petitioner argues that Ashkenazi in view of
Nitzan teaches that “a portion of the visible light that inactivates the one or
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more pathogenic Gram-positive bacteria consists of wavelengths in the range
400-420 nm,” as claim 1 requires.
Lastly, claim 1 requires that “the method is performed outside of the
human body and the contact surfaces or the materials are non-living.”
Ex. 1001, 8:3–5. For this limitation, Petitioner argues that the test tubes
used in Ashkenazi are located outside the human body, and constitute non-
living contact surfaces. Pet. 63 (citing Ex. 1010, 18; Ex. 1023 ¶ 196).
Petitioner presents a nearly identical analysis for claim 3, arguing that
claim 3 is substantially similar to claim 1, and that “there is no meaningful
difference between the language of these claims.” Pet. 64–66.
With the exception of the requirement in claims 1 and 3 of exposing
the bacteria to light “without using a photosensitizer,” Patent Owner does
not challenge Petitioner’s arguments that the combined disclosures of
Ashkenazi and Nitzan teach or suggest the limitations of claims 1 and 3. As
to what Ashkenazi and Nitzan disclose regarding the use of a
photosensitizer, Patent Owner first contends that Nitzan achieved
inactivation of MRSA only by using a photosensitizer, ALA. PO Resp. 58.
Patent Owner acknowledges that Ashkenazi discloses inactivating P. acnes
grown in the absence of ALA, but argues that Ashkenazi’s non-ALA-treated
samples were grown in the presence of other photosensitizers, such as
riboflavin. PO Resp. 58–59 (citing Ex. 2024 ¶¶ 118–123).
In particular, Patent Owner contends that at every stage of
Ashkenazi’s experiment, the tested P. acnes were present in reinforced
clostridial agar (RCA) or a reinforced clostridial broth (RCB), and that both
the RCA and RCB contained riboflavin. PO Resp. 59–60. According to
Patent Owner, “riboflavin was known to produce reactive oxygen species
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(“ROS”), such as singlet oxygen, when exposed to visible light,” and,
therefore, a person of ordinary skill in the art “would have expected that that
the riboflavin present in Ashkenazi’s RCB (in which the non-ALA P. acnes
were suspended when exposed to light) would have reacted with the light,
generated reactive oxygen species, and thereby enhanced inactivation of
even the non-ALA P. acnes.” PO Resp. 60–61. As a result, Patent Owner
contends that a person of ordinary skill in the art would have understood that
even Ashkenazi’s non-ALA-treated P. acnes samples still made use of a
photosensitizer, and concludes that Ashkenazi fails to disclose exposing
bacteria to light “without using a photosensitizer.” PO Resp. 61.
In its Reply, Petitioner does not dispute that riboflavin is a
photosensitizer or that it would be present in the RCA/RCB used in
Ashkenazi. Instead, Petitioner argues that Patent Owner attacks Ashkenazi
individually, instead of addressing the combined teachings of Ashkenazi and
Nitzan. Reply 18–19. In this regard, Petitioner asserts that a person of
ordinary skill in the art would not have necessarily used Ashkenazi’s
RCA/RCB to grow the MRSA used in Nitzan because clostridial broth/agar
are used to cultivate anaerobic bacteria, whereas MRSA is an aerobic
bacteria. Reply 19 (citing Ex. 1033 ¶¶ 74–77). According to Petitioner, a
person of ordinary skill in the art would have prepared MRSA as taught by
Nitzan, “aerobically, washed with PBS, and placed into sterile dishes.”
Reply 19. Petitioner contends that no riboflavin would have been present in
Nitzan’s PBS-washed MRSA, and thus the combined teachings of
Ashkenazi and Nitzan do disclose exposing bacteria to light without using a
photosensitizer. Reply 19 (citing Ex. 1033 ¶ 77).
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We are persuaded by Petitioner’s arguments. Petitioner has
presented evidence, including testimony from both Dr. Sulzinski and Dr.
Goodrich, demonstrating that a person of ordinary skill in the art would have
understood that MRSA is aerobic, and needs to be cultivated in aerobic
conditions. Ex. 1033 ¶ 77; Ex. 1034, 57:11–58:5 (Dr. Goodrich
acknowledging that MRSA is aerobic and would not “grow effectively” in
“an environment absent of oxygen”). This evidence supports Petitioner’s
argument that a person of ordinary skill in the art would not use Ashkenazi’s
anaerobic conditions to grow MRSA, but instead would have prepared the
MRSA as disclosed by Nitzan, and then exposed the MRSA to Ashkenazi’s
light dose. Reply 19–20. Petitioner has also presented undisputed evidence
that the aerobic growth conditions used in Nitzan would not include
riboflavin. Ex. 1033 ¶ 77.
Patent Owner did not address Petitioner’s aerobic growth conditions
arguments in its Sur-reply. And Patent Owner’s arguments and evidence
regarding the presence of riboflavin in RCA/RCB used to grow P. acnes in
Ashkenazi are misplaced as they focus on Ashkenazi individually, whereas
Petitioner relies on the combined teachings of Ashkenazi and Nitzan.
In view of this, the preponderance of evidence supports a finding that
the combined teachings of Nitzan and Ashkenazi disclose exposing bacteria
to light without using a photosensitizer.
Based on our review of the totality of the record after trial, we agree
with Petitioner’s arguments and evidence presented in the Petition
demonstrating that Ashkenazi and Nitzan disclose or suggest the limitations
of claims 1 and 3. Thus, we determine that the preponderance of the
evidence supports a finding that Petitioner has demonstrated that the
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combined disclosures of Ashkenazi and Nitzan teach or suggest all of the
limitations in claims 1 and 3.
2. Motivation to Combine Ashkenazi and Nitzan
Petitioner argues that a person of ordinary skill in the art would have
found it obvious to employ Ashkenazi’s techniques, using blue light to
inactivate P. acnes grown in the absence of exogenous ALA, to inactivate
MRSA grown in the absence of exogenous ALA, as disclosed in Nitzan.
Pet. 45. According to Petitioner, “[t]his would have simply been a
predictable variation on a known technique in the same field of endeavor
prompted by design incentives in that field.” Pet. 45. Petitioner argues that
the desire to find alternative approaches to treating bacteria such as MRSA
that have become resistant to antibiotics, as recognized by Nitzan,
constitutes the design incentive that would have prompted a person of
ordinary skill in the art to adapt Ashkenazi’s technique for the purpose of
inactivating MRSA. Pet. 45–46 (citing Ex. 1009, 430; Ex. 1023 ¶ 163).
Petitioner contends that employing Ashkenazi’s techniques using MRSA
instead of P. acnes would have been a simple substitution of one known
element for another to obtain predictable results, namely, the
photoinactivation of MRSA in the absence of ALA. Pet. 46.
Patent Owner does not dispute that Nitzan itself provided motivation
for finding methods for photoinactivating MRSA. PO Resp. 35 (citing Ex.
1009, 430–431). Accordingly, it is undisputed on this record that a person
of ordinary skill in the art would have understood that “[b]acterial resistance
to antibiotics ha[d] become a worldwide problem” and that “[r]esearch has
therefore been directed towards bacterial photodynamic inactivation as an
alternative approach to antimicrobial drug treatment.” Ex. 1009, 431
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(internal citations omitted). It is also undisputed that Nitzan tested the
photoinactivation of MRSA with and without the addition of ALA, and that
MRSA, like the P. acnes tested in Ashkenazi, is a Gram-positive bacteria.
Ex. 1009, 431; Ex. 1010, 17; PO Resp. 35; Pet. 45–46. Further, as Petitioner
points out, Nitzan identified studies showing the successful inactivation of
P. acnes when discussing “approach[es] for photoinactivation of bacteria.”
Ex. 1009, 430; Reply 2. This evidence supports Petitioner’s argument that a
person of ordinary skill in the art would have been prompted to employ and
adapt “Ashkenazi’s known technique of inactivating P. acnes in the absence
of exogenous ALA for the purpose and benefit of inactivating MRSA in the
absence of exogenous ALA.” Pet. 45–46; Ex. 1023 ¶ 163.
The evidence also supports Petitioner’s arguments that it would have
been obvious to try to inactivate MRSA in the absence of exogenous ALA
using Ashkenazi’s techniques. Pet. 47; KSR, 550 U.S. at 421. Ashkenazi
showed one type of Gram-positive bacteria could be inactivated with 407–
420 nm light in the absence or presence of ALA. Nitzan showed another
type of Gram-positive bacteria (MRSA) could be inactivated with the same
visible light in the presence of exogenous ALA. These facts support
Petitioner’s assertion that “the next logical step” would be to try inactivating
MRSA in the absence of exogenous ALA using the same visible light used
in Ashkenazi. Pet. 47.
In its Sur-reply, Patent Owner argues that Petitioner’s motivation to
combine Ashkenazi and Nitzan derives from “Ashkenazi’s inactivation of P.
acnes without using a photosensitizer,” which “would have motivated [a
person of ordinary skill in the art] to apply Ashkenazi’s techniques to
Nitzan’s MRSA.” Sur-reply 15. Patent Owner contends that Petitioner’s
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argument relies on an entirely false premise because Ashkenazi’s non-ALA
treated samples made use of riboflavin, which is a photosensitizer. Sur-reply
15–16. Thus, according to Patent Owner, Ashkenazi would not have
motivated a person of ordinary skill in the art to attempt to inactivate MRSA
“without using a photosensitizer.” Sur-reply 15–16.
We disagree. Regardless of the presence of riboflavin in the materials
used to grow Ashkenazi’s P. acnes, Ashkenazi still discloses the
photoinactivation of P. acnes in the absence of exogenous ALA. Ex. 1010,
19. It is this aspect of Ashkenazi, namely the photoinactivation of Gram-
positive bacteria in the absence of ALA, that Petitioner focuses on in arguing
a person of ordinary skill in the art would have had a reason to combine the
teachings of Ashkenazi and Nitzan. Pet. 45–47. Petitioner’s reason to
combine the teachings of Ashkenazi and Nitzan is not based on Ashkenazi’s
inactivation of P. acnes “without using a photosensitizer,” as Patent Owner
contends.13 Patent Owner’s argument here improperly focuses on “the
problem the patentee was trying to solve,” whereas “[u]nder the correct
analysis, any need or problem known in the field and addressed by the patent
can provide a reason for combining the elements in the manner claimed.”
KSR, 550 U.S. at 402.
In view of the foregoing, we find Petitioner has shown by a
preponderance of evidence that a person of ordinary skill in the art would
have had reason to combine the teachings of Nitzan and Ashkenazi.

13 Although not the reason for the combination, photoinactivation of MRSA
in the absence of a photosensitizer would follow from the combined
teachings of Ashkenazi and Nitzan, based on Nitzan’s growth of MRSA in
aerobic conditions, as discussed above.
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3. Reasonable Expectation of Success
Petitioner argues that “[t]he background knowledge of a [person of
ordinary skill in the art] and the teachings of Ashkenazi would have led the
[person of ordinary skill in the art] to reasonably expect success in
inactivating MRSA, a pathogenic Gram-positive bacteria, using 407-420 nm
light without applying exogenous ALA.” Pet. 48. In particular, Petitioner
argues that it was known in the art that S. aureus and P. acnes both naturally
produce and accumulate the same light reactive porphyrin: coproporphyrin,
and that S. aureus produces coproporphyrin in the absence of ALA. Pet. 48–
49 (citing Ex. 1023 ¶ 166; Ex. 1020, 58, 63); Reply 13–15 (citing Ex.
1021,14 270). Petitioner also argues that Ashkenazi and Nitzan identify the
same mechanism of bacterial inactivation—damage to the cell membrane
caused by free oxygen radicals released upon illumination of
coproporphyrin—for both P. acnes and S. aureus. Pet. 49–50 (citing Ex.
1023 ¶ 168; Ex. 1010, 22–23; Ex. 1009, 434); Reply 17. In view of this,
Petitioner asserts that a person of ordinary skill in the art would have known
that MRSA, like P. acnes, would have produced and accumulated
coproporphyrin, and that the coproporphyrin in MRSA would have released
free oxygen radicals upon exposure to a sufficient dose of 407–420 nm light,
for example the 75 J/cm2 used in Ashkenazi, which would have led to the
inactivation of the MRSA. Pet. 50.

14 Y. Nitzan et al., Endogenous Porphyrin Production in Bacteria by δ-
Aminolevulinic Acid and Subsequent Bacterial Photoeradication, LASERS
MED. SCI., 14 (1999), 269–277 (Ex. 1021). Patent Owner refers to this as
“Nitzan 1999.”
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Petitioner acknowledges one aspect of Nitzan’s study in which non-
ALA-treated MRSA exposed to 407–420 nm light at a dosage of 50 J/cm2
showed “no decrease in viability.” Pet. 51. Petitioner contends, however,
that this result does not undermine its assertions regarding a reasonable
expectation of success in applying Ashkenazi’s techniques to inactivate
MRSA without using ALA because the parameters used in Nitzan’s study
were significantly different from those used in Ashkenazi’s study. Pet. 51–
53; see also Pet. 54 (citing Soft Gel Techs., Inc. v. Jarrow Formulas, Inc.,
864 F.3d 1334, 1342 (Fed. Cir. 2017) and stating that “the standard for
obviousness is not absolute predictability but rather just a reasonable
expectation of success”).
Specifically, Petitioner points to differences in the intensity and
number of doses used in Ashkenazi (using multiple doses of 75 J/cm2 light)
and Nitzan (using a single dose of 50 J/cm2 light), and contends that
increased dosage intensity and number of exposures can result in increased
photoinactivation. Pet. 51–53; Reply 15–16. Petitioner also notes that
Ashkenazi allowed its samples to grow for 24 or 48 hours prior to testing,
and showed that a longer growth period enhanced the photoinactivation
effect of a 75 J/cm2 dose of 407–420 nm light on the non-ALA-treated
P. acnes. Pet. 53–54. According to Petitioner, “Nitzan’s result showing no
decrease in the viability of non-ALA-induced S. aureus after a short 4-hour
growth period does not support a conclusion that a POSA would have had no
reasonable expectation of success in inactivating non-ALA-induced MRSA
after a 24-hour or 48-hour growth period as taught by Ashkenazi.” Pet. 54
(citing Ex. 1023 ¶ 176).
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Patent Owner argues Petitioner fails to show that a person of ordinary
skill in the art would have been motivated to combine Ashkenazi and Nitzan
and would have had a reasonable expectation of success in doing so. PO
Resp. 31. Patent Owner emphasizes that Nitzan showed “no decrease in
viability” when MRSA incubated without ALA was treated with a dose of
50 J/cm2 of 407–420 nm light, whereas MRSA incubated with ALA was
“almost entirely eradicated” by the same dose of blue light. PO Resp. 46
(citing Ex. 1009, Table 5). According to Patent Owner, Nitzan concluded
that the photoinactivation exhibited by the ALA-induced MRSA was caused
by the presence of large amounts of coproporphyrin, and that “[t]he degree
of photoinactivation depends solely on the endogenous porphyrins,” not the
intensity of blue light applied or the number of light doses. PO Resp. 47
(quoting Ex. 1009, p. 433). Patent Owner argues that the authors in Nitzan
concluded that ALA must be used to produce sufficient amounts of
coproporphyrin in MRSA to enable photoinactivation by blue light, because
MRSA does not naturally produce and accumulate sufficient amounts of
coproporphyrin to enable photoinactivation by blue light. PO Resp. 35
(citing Ex. 1009, 433–434; Ex. 2024 ¶¶ 115–117 (stating “Nitzan therefore
concluded that ALA induction was required to photoinactivate MRSA.”), 47
(citing Ex. 2024 ¶¶ 101–103 (regarding MRSA’s ability to naturally produce
and accumulate sufficient coproporphyrin).
Patent Owner argues that the P. acnes bacteria studied in Ashkenazi
and Nitzan’s non-ALA-treated MRSA are “fundamentally different
bacteria.” PO Resp. 46. In particular, Patent Owner contends that
Ashkenazi discloses P. acnes naturally produces and accumulates large
amounts of porphyrins over time, whereas Petitioner fails to provide
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sufficient evidence demonstrating that MRSA produces and accumulates
coproporphyrin in the absence of a photosensitizer in an amount sufficient
for inactivation. PO Resp. 43 (citing Ex. 1010, 17; Ex. 2024 ¶¶ 92–94), 45
(citing Ex. 1009, 430 (“Since most bacterial species do not produce or
accumulate porphyrins . . . .”)), 47. According to Patent Owner, Ashkenazi
demonstrates that “the amount of endogenous coproporphyrin in bacteria is
the critical variable that determines how the bacteria responds to blue light.”
PO Resp. 38–39. In the absence of evidence demonstrating Nitzan’s non-
ALA-treated MRSA contained an sufficient amount of endogenous
porphyrin to enable photoinactivation, Patent Owner argues that nothing in
Ashkenazi would have led a person of ordinary skill in the art to believe that
using a higher dosage of light, repeated light dosages, or a longer incubation
period “would trigger inactivation in bacteria that (in the absence of a
photosensitizer) are entirely non-responsive to blue light at a lower
intensity.” PO Resp. 41–42, 50–56.
Patent Owner further argues that a person of ordinary skill in the art
would have been aware of Nitzan 1999, which undermines Petitioner’s
arguments regarding the use of higher dosages to inactivate MRSA.
PO Resp. 48–51. Patent Owner notes that in Nitzan 1999, MRSA incubated
with ALA showed increased inactivation as the intensity of blue light
increased, but MRSA incubated without ALA was entirely non-responsive
as the intensity levels increased. PO Resp. 49 (citing Ex. 1021, 270). In
view of this, Patent Owner concludes that “if bacteria exposed to 50 J/cm2 of
blue light showed no degree of inactivation at all (as in Nitzan), a [person of
ordinary skill in the art] would have concluded from Ashkenazi that the
bacteria needed more coproporphyrin to be inactivated—not that it needed a
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higher light intensity or more light doses.” PO Resp. 44 (citing Ex. 2024,
¶¶ 93–94).
After reviewing the parties’ arguments and evidence developed during
trial, we determine, for the reasons discussed below, the preponderance of
evidence supports a finding that a person of ordinary skill in the art would
have had a reasonable expectation of success in inactivating MRSA using
407–420 nm light without applying a photosensitizer based on the combined
teachings of Ashkenazi and Nitzan.
“The reasonable expectation of success requirement refers to the
likelihood of success in combining references to meet the limitations of the
claimed invention.” Intelligent Bio-Systems v. Illumina Cambridge, 821
F.3d 1359, 1367 (Fed. Cir. 2016). The ’706 patent claims require
inactivation of one or more pathogenic Gram-positive bacteria, including
MRSA, by exposing the bacteria to visible light without using a
photosensitizer. Ex. 1001, 7:17–24. The parties agree that in the context of
the ’706 patent, inactivation means “bacteria are killed, or damaged so as to
reduce or inhibit bacterial replication.” Ex. 1001, 2:44–46; Pet. 9; Sur-reply
1–2. Thus, here the relevant inquiry is whether a person of ordinary skill in
the art would have had a reasonable expectation of success in combining the
teachings of Ashkenazi and Nitzan such that one or more pathogenic Gram-
positive bacteria, including MRSA are killed, or damaged so as to reduce or
inhibit bacterial replication, by exposing the bacteria to visible light without
using a photosensitizer. Notably, the claims do not require any specific
amount of inactivation, nor do they require measuring inactivation in a
certain way.
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It is undisputed that Ashkenazi discloses the photoinactivation of non-
ALA-treated P. acnes, a Gram-positive bacteria, and that the
photoinactivation occurs due to the reaction of blue light with endogenous
coproporphyrin in the bacteria. Pet. 50; PO Resp. 37–39; Ex. 1010, 19–20.
Ashkenazi teaches that the P. acnes inactivation is the result of bacterial
membrane damage by free radicals released from light-activated porphyrins.
Ex. 1010, 22–23. Additionally, Ashkenazi teaches that “[i]n the case of P.
acnes or other bacterial cells that produce porphyrins, the blue light may
photoinactivate the intact bacterial cells as a consequence of the
photosensitizer molecules produced and stored within the bacterial cells.”
Ex. 1010, 21 (second emphasis added).
It is undisputed that MRSA is also a Gram-positive bacteria that
naturally produces porphyrins. Tr. 77:14–16 (counsel for Patent Owner
stating “[w]e don’t dispute . . . that there are some porphyrins in MRSA
naturally”), 78:4–9 (counsel for Patent Owner stating “[w]e’re not saying
that there’s no porphyrins at all [in non-ALA-treated MRSA]” and
“[c]ertainly there are some tests showing some porphyrins are present”);
Pet. 50; Reply 13–15; Ex. 1021, 270–271, Fig. 1(a). And similar to
Ashkenazi’s discussion of the mechanism of photoinactivation of P. acnes,
Nitzan teaches that S. aureus is inactivated by singlet oxygen radicals
released by coproporphyrin photosensitized with blue light. Ex. 1009, 434.
This evidence supports a finding that a person of ordinary skill in the art
would consider MRSA to be one of the “other bacterial cells” discussed in
Ashkenazi that “blue light may photoinactivate . . . as a consequence of the
photosensitizer molecules produced and stored within the bacterial cells.”
Ex. 1010, 21.
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The similarities between MRSA and P. acnes undermine Patent
Owner’s argument that a person of ordinary skill in the art would have
understood that non-ALA-treated MRSA is “a fundamentally different
bacteria from P. acnes.” PO Resp. 46. Patent Owner’s argument appears to
be based on Ashkenazi’s teachings that P. acnes are “known to naturally
produce high amounts of intracellular porphyrins,” but that other bacteria,
such as MRSA “naturally do not produce porphyrins in high amounts.”
PO Resp. 43–44; Ex. 1010, 21. We disagree that the difference in amount of
naturally produced porphyrins constitutes a fundamental difference between
MRSA and P. acnes. Although P. acnes may naturally produce more
porphyrins than MRSA, this does not change the fact that MRSA, like P.
acnes, naturally produces at least some porphyrins. And those porphyrins,
when illuminated with blue light, release radicals that can damage or kill the
bacteria. The fact that the claims do not require a particular amount of
inactivation diminishes the importance of the amount of porphyrins naturally
present in the bacteria. In view of this, Petitioner’s evidence that MRSA
naturally contains at least some porphyrins that react to blue light to damage
or kill bacterial cells, in combination with the teachings in Ashkenazi
regarding the successful photoinactivation of P. acnes based on the same
mechanism under various conditions, provides a reasonable expectation of
successfully achieving the claimed invention.
Nitzan’s disclosure that non-ALA-treated MRSA showed “no
decrease in viability” when exposed to blue light does not preclude a finding
of reasonable expectation of success in achieving the claimed invention.
Ex. 1009, 433. In conducting its test on non-ALA-treated MRSA, Nitzan
exposed the bacteria to a single dose of 50 J/cm2 of blue light. Ex. 1009,
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433. Nitzan’s experiments did not include exposing the non-ALA-treated
MRSA to more than a single dose of 50 J/cm2 light or to light at an intensity
over 50 J/cm2. Nor did Nitzan assess the effect of incubation time on
photoinactivity. Petitioner, however, has provided evidence demonstrating
that increasing the intensity of light, number of exposures, and incubation
time can affect inactivation.
For example, with regard to light intensity, Ashkenazi reports a two-
order decrease in the viability of cultures grown with ALA when illuminated
with a light dose of 75 J/cm2, and a three-order decrease when the same
cultures were illuminated by a light dose of 100 J/cm2. Ex. 1010, 20. With
regard to the number of doses, Ashkenazi reported that two consecutive
illuminations of cultures grown without ALA, at an interval of 24 h between
the treatments, caused a decrease in the viable count of the cultures by four
orders of magnitude, whereas three consecutive illuminations (at 24, 48 and
72 h) resulted in a decrease in viability of five orders of magnitude.
Ex. 1010, 19–20. By comparison, Ashkenazi reported a decrease between
one to two orders for cultures grown for 24 hours and exposed to a single
dose of 75 J/cm2 light. Ex. 1010, 19. As to incubation time, Ashkenazi
reported that cultures grown with ALA for 48 hours showed reduced
viability by seven orders of magnitude with a light dose of 75 J/cm2,
whereas cultures grown with ALA for 72 hours showed a decrease in
viability by seven orders of magnitude with a light dose of 50 J/cm2.
Ex. 1010, 20.
We note Patent Owner’s argument that “even with the benefit of
Ashkenazi’s prior research, Nitzan concluded the amount of endogenous
coproporphyrins in MRSA dictated the degree of photoinactivation—not the
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intensity of blue light applied or the number of light doses.” PO Resp. 47.
Patent Owner asserts that the results in Ashkenazi stem from the ability of
P. acnes to naturally produce and accumulate large amounts of porphyrins
over time, whereas Petitioner has not provided evidence showing MRSA
naturally produces and accumulates endogenous coproporphyrin in high
amounts. Pet. 37–44. Patent Owner further argues that if MRSA did
naturally produce and accumulate sufficient coproporphyrin to enable
photoinactivation by blue light, then a person of ordinary skill in the art
would have expected some measurable response to Nitzan’s 50 J/cm2 light
dose. PO Resp. 47–48. But since Nitzan reported “no decrease in viability”
at 50 J/cm2, Patent Owner argues a person of ordinary skill in the art would
have concluded that non-ALA-treated MRSA lacks sufficient amounts of
naturally produced coproporphyrin, and could not be inactivated without
using a photosensitizer regardless of the dosage intensity, number of doses,
or incubation time. PO Resp. 44–46. Given the insufficient amount of
endogenous coproporphyrin in Nitzan’s MRSA, Patent Owner asserts there
is nothing in Ashkenazi that would have led a person of ordinary skill in the
art to believe that increasing light intensity or number of doses would have
“trigger[ed] inactivation in bacteria that (in the absence of a photosensitizer)
are entirely non-responsive to blue light at a lower intensity.” PO Resp. 37,
41, 48.
We disagree. The presence of some naturally occurring porphyrins in
MRSA, combined with Ashkenazi’s disclosure regarding the effects of
intensity of light, number of doses, and incubation time provides a
reasonable expectation that increasing light intensity or the number of doses
could have “triggered” some amount of inactivation, as that term is defined
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in the ’706 patent. Moreover, Patent Owner’s arguments that MRSA lacks
“sufficient amounts” of naturally produced coproporphyrin for inactivation
with blue light relies on the statement in Nitzan that “[t]he degree of
photoinactivation depends solely on the endogenous porphyrins.” PO
Resp. 47. In isolation, the sentence seems to support Patent Owner’s
arguments, but when read in the full context of Nitzan’s study, the sentence
has a different meaning. Ex. 1009, 433. Nitzan not only conducted studies
regarding naturally produced porphyrins, but also studied the effect of
extracellular porphyrins on photoinactivation. Ex. 1009, 433. In reporting
the results, Nitzan states “[t]he conclusion that can be drawn from these
experiments is that the extracellular porphyrins do not contribute to the
photoinactivation. The degree of photoinactivation depends solely on the
endogenous porphyrins.” Ex. 1009, 433. Thus, the statement Patent Owner
relies on does not support the notion that photoinactivation depends only on
endogenous porphyrins – to the exclusion of any other factors. Instead, it
refers to the fact that Nitzan concluded that extracellular porphyrins do not
contribute to photoinactivation. This is consistent with Ashkenazi’s
conclusion “that the amount of endogenous porphyrin plays a role in
maintaining a successful phototreatment of P. acnes.” Ex. 1010, 22.
The totality of the evidence presented thus demonstrates that while the
amount of endogenous porphyrins plays a role, it is not the only factor to
consider. In view of the knowledge that non-ALA-treated MRSA contains
some porphyrins that are activated by exposure to blue light, and
Ashkenazi’s disclosure regarding increased inactivation based on dosage
intensity, number of doses, and incubation time, a person of ordinary skill in
the art would have understood that that changing the number of doses, light
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intensity, and/or incubation time in Nitzan’s experiments could have had an
impact on the inactivation of the non-ALA-treated MRSA.
Thus, at best, Nitzan’s disclosure of “no decrease in viability” would
have led a person of ordinary skill in the art to the limited conclusion that
non-ALA-treated MRSA incubated for 4 hours and treated with a single
dose of 50 J/cm2 light showed no decrease in activity. We reach a similar
conclusion for the data reported in Nitzan 1999, which only shows data up to
a light intensity of 50 J/cm2, the same intensity used in Nitzan. Ex. 1021,
273–274. In discussing these results in Nitzan 1999, Dr. Goodrich, states
that “the response of MRSA without ALA to blue light at 75 J/cm2 would
have been the same as 50 J/cm2—no bacteria would have been killed.”
PO Resp. 49–50; Ex. 2024 ¶ 104–107. Dr. Goodrich, however, fails to
provide the underlying facts forming the basis for that opinion. As a result,
it is entitled to little or no weight. 37 C.F.R. § 42.65(a).
In view of Ashkenazi’s teachings regarding the impact of light
intensity, number of doses, and incubation time, we agree with Petitioner
that the single data point from Nitzan does not demonstrate categorically that
non-ALA MRSA could not be inactivated by varying experimental factors
including light intensity or number of doses. Tr. 33:1–6; see also Tr. 67:20–
68:2 (noting that Nitzan did not control for variables such as light dosage,
number of exposures, or incubation time); Reply 10–11, 15–17. The same is
true with regard to Nitzan 1999’s testing, which does not provide data
beyond a light intensity of 50 J/cm2. Ex. 1021, 273–274. The limited data
from Nitzan and Nitzan 1999 does not outweigh the evidence Petitioner has
provided supporting a finding of reasonable expectation of success of
achieving the claimed invention, including the presence of coproporphyrins
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in non-ALA-treated MRSA and the mechanism of inactivation with blue
light, in addition to the effect of increasing light dosage, number of doses,
and incubation time on inactivation. This is especially true considering
Petitioner need not show absolute predictability, only a reasonable
expectation of success, and the claimed invention does not require any
particular amount of inactivation or recite a particular dosage intensity or
number of doses. See Noelle v. Lederman, 355 F.3d 1343, 1352 (Fed. Cir.
2004) (holding that a reasonable expectation of success “does not
necessarily mean an absolute predictability”).
Accordingly, we agree with Petitioner that under the proper
interpretation of “inactivation,” the preponderance of evidence supports a
person of ordinary skill in the art’s “reasonable expectation that the
porphyrins MRSA produces and accumulates (e.g., coproporphyrin) would
have been sufficient to reduce or inhibit its replication upon exposure to a
sufficient dose of blue light without using a photosensitizer.” Reply 9.
4. Objective Indicia of Nonobviousness
Patent Owner argues that objective indicia of non-obviousness weigh
in favor of finding the challenged claims patentable. PO Resp. 62. In
particular, Patent Owner argues numerous researchers attempted and failed
to inactivate MRSA without using a photosensitizer, the ability to inactivate
MRSA (as well as the other Gram-positive bacteria recited in the claims)
with blue light and without using a photosensitizer was not predictable and
was an unexpected result, and there has been a long-felt but unmet need for
“efficient, convenient, and effect[ive] methods of inactivating the Gram-
positive bacteria recited in the challenged claims.” PO Resp. 62.
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Petitioner argues that Patent Owner’s objective indicia fail to refute
the prima facie showing of obviousness because Patent Owner fails to
provide evidence showing unexpected results, failure of others, or a long-felt
but unresolved need that is commensurate with the scope of the claims.
Pet. 20. In particular, Petitioner argues that the scope of the claims extends
to “inactivating . . . Gram-positive bacteria in the air,” but Patent Owner
“provides no evidence of unexpected results from exposing airborne MRSA
to blue light or failed attempts to inactivate airborne MRSA,” and that Patent
Owner’s “assertions about the purportedly long-felt need contain only
minimal reference to airborne bacteria.” Reply 20 (citing Ex. 1001, 4:24-47,
6:9-14).
Patent Owner did not respond to Petitioner’s argument in its Sur-
reply.
To be relevant, evidence of objective indicia of nonobviousness must
be commensurate in scope with the claimed invention. In re Kao, 639 F.3d
1057, 1068 (Fed. Cir. 2011). This does not mean Patent Owner is “required
to test every embodiment within the scope of his or her claims.” Id. Rather,
if Patent Owner demonstrates objective indicia related to one embodiment,
“and provides an adequate basis to support the conclusion that other
embodiments falling within the claim will behave in the same manner, this
will generally establish that the evidence is commensurate with [the] scope
of the claims.” Id.
Patent Owner’s evidence of failure of others is directed to attempts to
inactivate MRSA on contact surfaces or materials without using a
photosensitizer, as reported in Nitzan and Nitzan 1999. PO Resp. 62 (citing
Ex. 1009; Ex. 1021). The claims, however, recite “[a] method for
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disinfecting air, contact surfaces or materials by inactivating one or more
pathogenic Gram-positive bacteria in the air, on the contact surfaces or on
the materials,” wherein the Gram-positive bacteria “are selected from the
group consisting of Methicillin-resistant Staphylococcus aureus (MRSA),
Coagulase-Negative Staphylococcus (CONS), Streptococcus, Enterococcus,
and Clostridium species.” Ex. 1001, 7:17–26. Thus, the claims encompass
bacteria other than MRSA, and are not limited to inactivation of these
bacteria on surfaces or materials. Patent Owner, however, fails to direct us
to any portion of Nitzan and Nitzan 1999 that discloses inactivation of
MRSA in air. Nor does Patent Owner direct us to evidence regarding the
failure of others to inactivate Coagulase-Negative Staphylococcus (CONS),
Streptococcus, Enterococcus, and Clostridium species without a
photosensitizer in air, on a contact surface, or on materials. Further, Patent
Owner does not provide an adequate basis to support a conclusion that
Coagulase-Negative Staphylococcus (CONS), Streptococcus, Enterococcus,
and Clostridium species would behave in the same manner as MRSA, such
that Patent Owner’s evidence regarding MRSA is commensurate in scope
with the claims. Kao, 639 F.3d at 1068.
Similarly, in support of its argument that “the ability to inactivate
MRSA (among other recited Gram-positive [bacteria]) with blue light and
without using a photosensitizer was not predictable by a person of ordinary
skill and was an unexpected result of the inventors’ research,” Patent Owner
relies on “the reasons discussed with respect to Ground C.” PO Resp. 62.
Patent Owner’s arguments regarding Ground C appear on pages 30–58 of its
Patent Owner Response, and primarily address the question of whether a
person of ordinary skill in the art would have had a reasonable expectation
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of success inactivating MRSA without a photosensitizer in view of the
combined disclosures of Ashkenazi and Nitzan. Patent Owner does not
direct us to where in this discussion of Ground C it provides evidence
regarding the inactivation of Coagulase-Negative Staphylococcus (CONS),
Streptococcus, Enterococcus, and Clostridium species, or an adequate basis
to support a conclusion that Coagulase-Negative Staphylococcus (CONS),
Streptococcus, Enterococcus, and Clostridium species would behave in the
same manner as MRSA, such that Patent Owner’s evidence regarding
MRSA is commensurate in scope with the claims. Nor does Patent Owner
direct us to any portion of its discussion of Ground C addressing inactivation
of MRSA in the air.
With regard to its argument of a long-felt but unmet need, Patent
Owner cites the need for “efficient, convenient, and effect[ive] methods” of
inactivating the bacteria outside the human body, i.e., in air, on non-living
contact surfaces, and on non-living materials, and contends that “[t]he
invention of the ’706 patent solved this problem.” PO Resp. 62; see also PO
Resp. 3 (discussing the aim of the ’706 patent).
To the extent there was a need for a “simple and effective” technique
for inactivating the claimed bacteria, Patent Owner does not direct us to
evidence demonstrating it was “long-felt.” The ’706 patent describes MRSA
as “increasingly problematic,” and states that “[p]ublic and media interest in
the transmission and control of MRSA is escalating,” and that “community-
acquired MRSA is also now being recognised as an increasing problem.”
Ex. 1001, 1:23–35. This language suggests that the ’706 patent was
intended to address more recent problems arising closer to the filing date of
the patent, as opposed to a long-felt need.
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For all of the foregoing reasons, we find Patent Owner’s evidence of
objective indicia does little or nothing to demonstrate the nonobviousness of
the claimed subject matter.
5. Conclusion
We have considered the entirety of the evidence, including the
evidence of objective indicia of nonobviousness. As discussed above, based
on the present record, Petitioner has established sufficiently that Ashkenazi
and Nitzan teach or suggest all the limitations of claims 1 and 3, that a
person of ordinary skill in the art would have been motivated to combine the
references to arrive at the claimed invention, and that a person of ordinary
skill in the art would have had a reasonable expectation of successfully
doing so. Patent Owner’s weak evidence of objective indicia of
nonobviousness does not outweigh the strong case for obviousness of claims
1 and 3 as outlined above.
We thus conclude that Petitioner has demonstrated by a
preponderance of the evidence that claims 1 and 3 are unpatentable as
obvious under 35 U.S.C. § 103(a) over Ashkenazi and Nitzan.
G. Claims 2 and 4 – Alleged Obviousness in view of Ashkenazi,
Nitzan, and Jones
Claims 2 and 4 depend from claims 1 and 3 respectively, and further
require that the “visible light that inactivates has a wavelength of 405 nm.”
Ex. 1001, 8:6–7 (claim 2), 8:24–25 (claim 4). Petitioner acknowledges that
Ashkenazi does not specifically disclose light having a wavelength of 405
nm, but asserts that Jones teaches that bacterial porphyrins in P. acnes
optimally produce singlet oxygen when exposed to 405 nm light. Pet. 65.
Petitioner contends that a person of ordinary skill in the art “would have
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been motivated to use 405 nm for the purpose of achieving optimum
activation of the coproporphyrin in the MRSA to be inactivated using
Nitzan’s techniques,” and would have every reason to expect success in
employing 405 nm light to inactivate MRSA. Pet. 42, 65–66.
Patent Owner does not substantively address Petitioner’s arguments
that Jones discloses the additional limitations in claims 2 and 4, or that a
person of ordinary skill in the art would have had a reason to combine the
teachings of Jones with those of Ashkenazi and Nitzan. PO Resp. 63.
Instead, Patent Owner relies on its previously presented arguments that “the
combination of Ashkenazi and Nitzan fails to disclose or render obvious the
claim elements for which they are relied upon.” PO Resp. 63.
Based on our review of the present record, Petitioner has established
by a preponderance of evidence that Ashkenazi, Nitzan, and Jones teach or
suggest all the limitations of claims 2 and 4, that a person of ordinary skill in
the art would have been motivated to combine the teachings of the
references to arrive at the claimed invention, and that a person of ordinary
skill in the art would have had a reasonable expectation of successfully
doing so.
As Petitioner points out, Jones teaches that bacterial porphyrins
naturally occurring in P. acnes “produce[] singlet oxygen . . . when excited
by light of a wavelength of around 405 nm.” Ex. 1007 ¶ 24; Pet. 41, 65–66.
Jones also teaches that these oxygen singlets may destroy the bacteria.
Ex. 1007 ¶ 24. These teachings in Jones, combined with the fact that Nitzan
recognized that the same porphyrin–coproporphyrin–is present in both
P. acnes and Staphylococcal strains (Ex. 1009, 434) supports Petitioner’s
assertion that a person of ordinary skill in the art “would have been
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motivated to use 405 nm for the purpose of achieving optimum activation of
the coproporphyrin in the MRSA to be inactivated using Nitzan’s
techniques.” Pet. 42 (citing Ex. 1023 ¶ 158), 65–66. It also supports
Petitioner’s argument that a person of ordinary skill in the art would have a
reasonable expectation of success in employing 405 nm light to inactivate
MRSA. Pet. 42, 65–66.
For these reasons, in addition to those presented above addressing the
combination of Ashkenazi and Nitzan with regard to claims 1 and 3, we find
Petitioner has demonstrated by a preponderance of evidence that claims 2
and 4 are unpatentable as obvious in view of Ashkenazi, Nitzan, and Jones.
III. MOTION TO EXCLUDE
Patent Owner filed a Motion to Exclude Evidence, seeking to exclude
several paragraphs of Dr. Sulzinski’s Reply Declaration. Paper 33
(“Motion”). Petitioner filed an Opposition to the Motion (Paper 34), and
Patent Owner subsequently filed a Reply to Petitioner’s Opposition
(Paper 36).
In its Motion, Patent Owner contends that Dr. Sulzinski’s Reply
Declaration is more than double the allowable length of Petitioner’s Reply
and is a “blatant attempt to circumvent the Board’s word limit for
Petitioner’s Reply.” Mot. 1. Petitioner also contends that our rules
expressly prohibit incorporating arguments by reference, and that
“[c]onsideration of arguments included in Dr. Sulzinski’s Reply
Declaration—but not developed and presented in Petitioner’s Reply—would
lead to fundamental unfairness in this proceeding and would be prejudicial
to Patent Owner.” Mot. 2.
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The only paragraphs in Dr. Sulzinski’s Reply Declaration that we rely
upon for purposes of this Final Written Decision are paragraphs 74–77.
These paragraphs relate to Patent Owner’s argument that riboflavin is a
photosensitizer and is present in Ashkenazi’s growth and incubation media.
Mot. 8. Patent Owner contends that these paragraphs cannot be considered
by the Board without allowing Petitioner to circumvent the Reply word
count limit. Mot. 8–9.
We disagree. As Patent Owner acknowledges, Petitioner discusses
these paragraphs on page 19 of the Reply. Mot. 8. In particular, Petitioner
cites these paragraphs to support fully developed arguments in the Reply
regarding the growth of MRSA in aerobic conditions. Reply 19.
Dr. Sulzinski not only presents his opinions in these paragraphs, but also
presents the factual basis supporting his opinions, as required by our rules.
See 37 C.F.R. § 42.65(a). In view of this, we are not persuaded that these
paragraphs of Ex. 1033 are unfairly prejudicial and therefore inadmissible,
thus, we deny Patent Owner’s motion with regard to paragraphs 74–77.
Because we do not rely on any of the remaining paragraphs addressed
in Patent Owner’s Motion for purposes of our Final Written Decision, we
deny the remainder of Patent Owner’s Motion as moot.
IV. CONCLUSION
For the foregoing reasons, Petitioner has demonstrated by a
preponderance of evidence that claims 1–4 of the ’706 patent are
unpatentable as obvious over the prior art of record.
In summary:

IPR2019-00431
Patent 9,839,706 B2
53

V. ORDER
It is hereby,
ORDERED that claims 1–4 of the ’706 patent are held unpatentable;
FURTHER ORDERED that Patent Owner’s Motion to Exclude is
denied; and
FURTHER ORDERED that because this is a Final Written Decision,
the parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

Claims 35 U.S.C § Reference(s)
Claims
Shown
Unpatentable
Claims
Not shown
Unpatentable
1, 3 102 Nitzan 1, 3
2, 4 103 Nitzan, Jones 2, 4
1, 3 103 Ashkenazi,
Nitzan 1, 3
2, 4 103 Ashkenazi,
Nitzan, Jones 2, 4
Overall
Outcome 1–4
IPR2019-00431
Patent 9,839,706 B2
54

For PETITIONER:

Binal Patel
Brian Emfinger
Matthew Becker
Christopher Galfano
bpatel@bannerwitcoff.com
bemfinger@bannerwitcoff.com
mbecker@bannerwitcoff.com
cgalfano@bannerwitcoff.com

For PATENT OWNER:

Christopher Kelly
Jason Cooper
chris.kelly@alston.com
jason.cooper@alston.com