Paithankar et al.v.Harris et al.

Patent Trial and Appeal Board

Aug 9, 2016

14020481 (P.T.A.B. Aug. 9, 2016)

BoxInterferences@uspto.gov Filed: August 9, 2016
Tel: 571-272-7822

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

The General Hospital Corp.
(Inventors: Dilip Paithankar, Richard Dean Blomgren, Richard Rox Anderson,
William A. Farinelli, Apostolos G. Doukas, and Gerard van Hamel Platerink)

Junior Party
(Patent 13/789,575),

v.
Sienna Biopharmaceuticals, Inc.
(Inventors: Todd James Harris and Alice Ann Chen Kim)

Senior Party
(Patent 8,821,941).

Patent Interference No. 106,037 (DK)
(Technology Center 1600)

Judgment
37 C.F.R. § 41.127

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

KATZ, Adminstrative Patent Judge.

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As explained in the Decision on Motions (Paper 315), the claims of Junior 1
Party, The General Hospital Corporation (“GHC”), have been found to lack written 2
description support under 35 U.S.C. § 112, first paragraph. 3
It is ORDERED that claims 65-67 of GHC’s involved application 4
13/789,575 be FINALLY REFUSED. 5
It is further ORDERED that a party seeking judicial review timely serve 6
notice on the Director of the United States Patent and Trademark Office. 37 C.F.R. 7
§§ 90.1 and 104.2. See also 37 C.F.R. 41.8(b). Attention is directed to Biogen Idec 8
MA, Inc., v. Japanese Foundation for Cancer Research, 785 F.3d 648, 654–57 9
(Fed. Cir. 2015) (cert. denied 2016 WL 1078942, Mar 21, 2016) (determining that 10
pre-AIA § 146 review was eliminated for interference proceedings declared after 11
September 15, 2012). 12
It is further ORDERED that a copy of this judgment be entered into the 13
administrative records of GHC’s application 13/789,575 and Senior Party, Sienna 14
Biopharmaceuticals, Inc., patent 8,821,941. 15

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cc (via e-mail): 1
Attorney for Junior Party General Hospital: 2
3
Peter C. Lauro 4
Brian R. Landry 5
SAUL EWING LLP 6
plauro@saul.com 7
blandry@saul.com 8
9
10
Philippe Bennett 11
Walter Scott 12
ALSTON & BIRD, LLP 13
philippe.bennett@alston.com 14
scott@alston.com 15
16
17
Attorney for Senior Party Sienna: 18
19
Brenton R. Babcock 20
Salima A. Merani 21
Ted M. Cannon 22
KNOBBE, MARTENS, OLSON & BEAR, LLP 23
BoxSienna@knobbe.com 24
25
Michael R. Fleming 26
IRELL & MANELLA LLP 27
MFleming@irell.com 28
29
BoxInterferences@uspto.gov Filed: August 9, 2016
Tel: 571-272-7822

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

The General Hospital Corp.
(Inventors: Dilip Paithankar, Richard Dean Blomgren, Richard Rox Anderson,
William A. Farinelli, Apostolos G. Doukas, and Gerard van Hamel Platerink)

Junior Party
(Patent 13/789,575),

v.
Sienna Biopharmaceuticals, Inc.
(Inventors: Todd James Harris and Alice Ann Chen Kim)

Senior Party
(Patent 8,821,941).

Patent Interference No. 106,037 (DK)
(Technology Center 1600)

DECISION ON MOTIONS
37 C.F.R. § 41.125(a)

Before RICHARD E. SCHAFER, SALLY GARDNER LANE, and
DEBORAH KATZ, Administrative Patent Judges.

KATZ, Adminstrative Patent Judge.

Interference 106,037

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I. Introduction 1
A. 2
Junior Party, The General Hospital Corporation (“GHC”)1 suggested this 3
interference based on claims 65-67 of its involved application 13/789,575 (“the 4
’575 application”). 5
Senior Party, Sienna Labs, Inc. (“Sienna”) is involved based on all 6
claims (1-10) of its patent 8,821,941 (“the ’941 patent”). 7
The parties claim methods using particles on a nanometer size scale – 8
“nanoparticles” – to damage hair follicles in order to remove hair or reduce its 9
growth. The nanoparticles absorb light and generate plasmon resonance at a 10
desired wavelength in order to heat the hair follicle and damage it. (See 11
’941 patent at 2:57-61.) The parties’ claimed methods use a composition 12
comprising particles (“unassembled plasmonic nanoparticles”) that have a 13
conductive metal portion and are coated (for example with polyethylene glycol 14
(“PEG”)) to facilitate removal from the skin. First, the composition is applied to 15
the skin so that the nanoparticles can enter the hair follicle. Then, excess 16
composition is removed, leaving the nanoparticles in the hair follicle. The 17
nanoparticles are then irradiated with an infrared light to thermally damage the 18
follicle. 19

1 GHC reports that Sebacia, Inc. has certain rights through a license to the
inventions of GHC’s application 13/789,575. (Paper 13.)
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GHC claim 65 is representative of GHC’s involved claims 65-67. Claim 65 1
recites: 2
A method of localizing thermal damage to a hair follicle, comprising: 3
applying a composition to a skin surface, 4
wherein said composition comprises a plurality of unassembled 5
plasmonic nanoparticles, 6
wherein the unassembled plasmonic nanoparticles comprise a 7
conductive metal portion, 8
wherein the conductive metal portion comprises gold, 9
wherein the unassembled plasmonic nanoparticles have a diameter of 10
about 150 nm, 11
wherein the unassembled plasmonic nanoparticles comprise a coating 12
that coats the conductive metal portion, wherein said coating facilitates 13
selective removal from the skin surface, 14
wherein the coating comprises polyethylene glycol (PEG), 15
wherein the unassembled plasmonic nanoparticles have a 16
concentration of about 6.6 × 1011 particles per ml of the composition, 17
wherein said concentration is sufficient to, after exposure to irradiation, 18
induce thermal damage in the hair follicle; 19
distributing the composition from the skin surface to the hair follicle 20
to target the hair follicle; 21
selectively removing the composition from the skin surface, while 22
leaving the composition localized within the hair follicle; and 23
irradiating the composition with an infrared light source thereby 24
inducing a plurality of surface plasmons in said unassembled plasmonic 25
nanoparticles, 26
wherein the induction of the surface plasmons generates thermal 27
damage to the hair follicle for at least one of hair removal or hair growth 28
reduction. 29
30
(GHC Clean Copy of Claims, Paper 14.) 31
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B. 1
Sienna argues in its Motion 1 that GHC’s ’575 application lacks sufficient 2
written description support for claims 65-67 under 35 U.S.C. § 112, first 3
paragraph. We grant Sienna Motion 1. 2 4
Contingent on the grant of Sienna Motion 1, GHC requests the addition of 5
proposed claim 74 to its involved ’575 application in its Responsive Motion 4. We 6
deny GHC Responsive Motion 4. 7
Both parties also argue that evidence relied upon by the other should be 8
excluded. (See Sienna Motion Miscellaneous Motion 3, Paper 250; GHC 9
Miscellaneous Motion 8, Paper 304.) To the extent we rely on the argued 10
evidence, we discuss the arguments for exclusion below. 11
Because of our holding that GHC does not have written descriptive support 12
for the subject matter it essentially copied from Sienna’s patent, GHC has an 13
insufficient basis to challenge Sienna’s right to its claimed subject matter. 14
Therefore, Sienna lacks standing in this interference and we terminate the 15
interference without consideration of any other substantive motions.3 16

2 Sienna requests oral argument. (Paper 251.) After review of the parties’ briefs
and supporting evidence, oral argument is not necessary.
3GHC also filed Motion 1 for benefit of a provisional application (Paper 151);
Motion 2, challenging Sienna’s claims under 35 U.S.C. § 112, first paragraph, for
lack of written description and an enabling disclosure (Paper 152); and Motion 3
arguing that Sienna is not entitled to the benefit accorded to it (Paper 153). Sienna
also filed Motion 2, aruing for the benefit of provisional applications (Paper 85).
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1
II. Sienna Motion 1 – Unpatentability under 35 U.S.C. § 112, first 2
paragraph 3
Sienna argues that all of GHC’s involved claims lack written description 4
under 35 U.S.C. § 112, first paragraph. (Sienna Motion 1, Paper 84.) Whether the 5
description requirement is met is a question of fact. Vas-Cath Inc. v. Mahurkar, 6
935 F.2d 1555 (Fed.Cir.1991). Specifically, the test for written description under 7
35 U.S.C. § 112, first paragraph, “is whether the disclosure of the application 8
relied upon reasonably conveys to those skilled in the art that the inventor had 9
possession of the claimed subject matter as of the filing date.” Ariad Pharm., Inc., 10
v. Eli Lilly & Co., 598 F3d 1336, 1351 (Fed. Cir. 2010). 11
Sienna argues that GHC lacks written description for two limitations that are 12
present in each of claims 65-67: (1) a “concentration of about 6.6 X 1011 particles 13
per ml of the composition” and (2) “unassembled plasmonic nanoparticles.” 14
A. 15
GHC relies on the testimony of Ivan J. Dmochowski. (See, e.g. Fourth 16
Declaration of Ivan J. Dmochowski (“Fourth Dmochowski Decl.”) Exh. 2093.) 17
Dr. Dmochowski testifies that he received a Ph.D. in Bioinorganic Chemistry and 18
is currently a Professor of Chemistry at the University of Pennsylvania. 19
(Declaration of Ivan J. Dmochowski Decl. (“First Dmochowski Decl.”), 20
Exh. 2026, at ¶¶ 1-2.) He testifies further that he has studied plasmonic 21
nanoparticles since 2003 and is currently working on the interaction of gold 22
nanoparticles with a biological protein. (Id. at ¶ 4.) Dr. Dmochowski’s curriculum 23
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vitae indicates that he has authored many peer-reviewed publications and has 1
received numerous research awards, honors and grants. (See Second Declaration 2
of Ivan J. Dmochowski, Exh. 2025, at ¶ 2, citing Dmochsowksi curriculum vitae, 3
Exh. 2027.) We find Dr. Dmochowski to be qualified to testify about 4
nanoparticles. 5
Sienna relies on the testimony of Andrea Tao. Ph.D. (Exh. 1002). Dr. Tao 6
testifies that she has worked in the field of nanomaterials chemistry, specifically 7
plasmonic nanoparticles, for 14 years, currently as a Professor of Engineering and 8
Principal Investigator of the Nanoscale Colloids and Interfaces Laboratory in the 9
Nanoengineering Department at the Unversity of California San Diego. 10
(Declaration of Andrea Tao, Ph.D. (“Tao Decl.”), Exh. 1002, at ¶¶ 6-7.) Dr. Tao 11
testifies that she received a Ph.D. in Chemistry from the Unversity of California 12
Berkley, where she worked on the synthesis and assembly of inorganic 13
nanomaterials, including plasmonic nanoparticles, and worked as a postdoctoral 14
fellow at the University of California Santa Barbara in the Department of 15
Molecular, Cellular, and Developmental Biology. (Id. at ¶¶ 10-11.) She also 16
testifies that she has received numerous research awards and authored many peer-17
reviewed publications. (Id. at 8 and 13; see Tao curriculum vitae, Exh. 1003.) 18
GHC argues that Dr. Tao is not qualified to testify as an expert in this 19
interference because she lacks experience using nanoparticles in cosmetic, 20
diagnostic, and/or therapeutic procedures.4 (See GHC Opp. 1, Paper 222, at 7:23-21

4 We note that GHC’s witness, Dr. Dmochowski, does not testify about any
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8:27 and 12, n.5; see also GHC Motion to Exclude, Paper 304, at 2:23-3:9.) We do 1
not agree. Dr. Tao’s experience and credentials indicate that she has significant 2
experience with nanoparticles. Thus, she is qualified to testify about nanoparticles 3
in general, even if she may not be qualified to testify about cosmetic, diagnostic, or 4
therapeutic procedures. 5
We note that all witnesses must disclose the underlying facts or data on 6
which their opinion is based in order for significant weight to be accorded to the 7
opinion. See 37 C.F.R. § 41.158(a) (“Expert testimony that does not disclose the 8
underlying facts or data on which the opinion is based is entitled to little or no 9
weight.”) Thus, we evaluate the weight to be accorded to Dr. Tao’s testimony 10
based on the sufficiency of the evidence supporting the underlying facts. 11
B. 12
We first take up Sienna’s arguments regarding the lack of written description 13
for GHC’s claim phrase “about 6.6 X 1011 particles per ml” under 35 U.S.C. § 112, 14
first paragraph. (Sienna Motion 1, Paper 84, at 14:24-23:22.) 15
Sienna argues that the term “about” in GHC’s claims is properly construed 16
to mean “within 10% of.” Sienna cites to the use of the term “about” in Sienna’s 17
specification and to its definition in GHC’s specification in support. Specifically, 18
GHC’s specification provides: 19

experience in the field of hair removal or reduction in growth, acne treatment, or
any other cosmetic treatment. (See Declaration of Ivan J. Dmochowski, Exh. 2026,
at ¶¶ 1-7.)
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Unless specifically stated or obvious from context, as used herein, the 1
term “about” is understood as within a range of normal tolerance in 2
the art, for example Within 2 standard deviations of the mean. About 3
can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 4
1%, 0.5%, 0.1%, 0.05%, or 0.01% of the stated value. Unless 5
otherwise clear from context, all numerical values provided herein are 6
modifed by the term about. 7
8
(GHC ’575 application, Exh. 1024, at ¶ 43.) Dr. Tao testifies that Sienna’s 9
specification also reflects this range of variation. (See Tao Decl., Exh. 1002, at 10
¶ 72.) We agree that the construction of “about” provided in both parties’ 11
specifications is most reasonably “within 10%.”5 12
In light of this construction, Sienna argues that the proper construction of 13
GHC’s claim term “about 6.6 X 1011 particles per ml” is a range of at most from 14
5.94 x 1011 to 7.26 x 1011 particles per ml. (Sienna Motion 1, Paper 84, at 15:11-15
17:28, citing Tao Decl., Exh. 1002, at ¶ 79. 6) GHC does not argue to the contrary. 16

5 As Sienna notes (Sienna Reply 1, Paper 230, at 3:18-22), Dr. Dmochowski
testifies that becaue the optical density of formulation F78 is reported with two
different O.D.s in two parts of GHC’s specification, one of skill in the art would
have considered a 20% variation to be acceptable. (See (Fourth Dmochowski
Decl., Exh. 2093, at ¶¶ 15 and 16.) GHC does not rely on this testimony or argue
that Dr.Tao’s determination of “about” as being a 10% variation is incorrect.
Accordingly, we do not consider Dr. Dmochowski’s testimony about this issue in
our analysis.
6 In its Motion to Exclude, GHC argues that Dr. Tao’s testimony regarding the
meaning of “about” is not supported and should be excluded. (See GHC Motion 8,
Paper 304, at 6:9-12.) We disagree because Dr. Tao relies on GHC’s and Sienna’s
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Both Sienna and GHC agree that GHC’s specification does not disclose the 1
recited, or any, concentration in particles per ml. (See Sienna Motion 1, Paper 84, 2
at 15:1-3; GHC Opp. 1, Paper 222, at App’x 2, p. 3, response to Sienna Material 3
Fact 11.) Instead, GHC’s specification provides the “optical density” (“O.D.”) of 4
solutions of nanoparticles. (See, e.g. GHC ’575 appl., Exh. 1024, at ¶¶ 100 5
(Example 4) and p. 9, Table 1 (Example 9).) According to Sienna, when the O.D. 6
measurements reported in GHC’s specification are properly converted,7 they do not 7
indicate a concentration of about 6.6 x 1011 particles per ml. (Sienna Motion 1, 8
Paper 84, at 18:8-22:2.) 9
Sienna relies on the testimony of Dr. Tao to support its argument. 10
According to Dr. Tao, the proper extinction coefficient to convert an O.D. 11
measurement to a concentration is 4.2 because of the wavelength used. (Sienna 12
Motion 1, Paper 84, at 18:24-21:16, citing Tao Decl., Exh. 1002, at ¶¶ 87-89.) Dr. 13
Tao testifies that using the correct extinction coefficient for the O.D. reported in 14
GHC’s Example 4 (250 O.D.) results in a concentration of 7.77 x 1011 particles per 15
ml results. (Id.) But 7.77 x 1011 particles per ml falls outside the construed 16
meaning of “about 6.6 x 1011 particles per ml” or 5.94 x 1011 to 7.26 x 1011 17

specifications for her testimony. (See Tao Decl., Exh. 1002, at ¶¶ 72 and 74.)
7 Sienna also argues that conversion of O.D. meaurements is merely an estimate of
the concentration of nanoparticles. (Sienna Motion 1, Paper 84, at 18:25-19:2.)
Although Sienna relies on the testimony of Dr. Tao in support, we are not
persuaded because Dr. Tao does not explain her opinion. (See Tao Decl., Exh.
1002, at ¶84.)
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particles per ml. Dr. Tao testifies further that when the O.D. measurements 1
reported in Example 9 of GHC’s specification (275 and 300 O.D.) are properly 2
converted to concentrations (8.53 x 1011 and 9.31 x 1011 particles per ml, 3
respectively), they fall even further outside the range claimed by GHC. (See Tao 4
Decl., Exh. 1002, at ¶ 91.) 5
GHC does not argue that Dr. Tao’s determination of the extinction 6
coefficient or her calculations are incorrect. (See GHC Opp. 1, Paper 222, at 19:4-7
20:23.) Nor does GHC argue or direct us to evidence showing that the 8
concentration recited in claims 65-67 is supported by a specific optical denisity 9
expressly recited in GHC’s specification. 10
When it suggested this interference, GHC relied on Dr. Dmochowski’s 11
original testimony that the claimed concentration is supported by O.D.s reported in 12
Table 1 of GHC’s specification using the extinction coefficient of 5.5. (See First 13
Dmochowski Decl., Exh. 1026, at ¶ 51.) Dr. Tao’s testimony to the contrary is 14
supported by Jain8 (Exh. 1012) and by the references in GHC’s specification to 15
pulsed laser irradiation at 800 nm, the wavelength she used to determine the 16
extinction coefficient of 4.2 in light of the teachings in Jain. (See Tao Decl., Exh. 17
1002, at ¶¶ 85-87.) Accordingly, we credit Dr. Tao’s testimony over Dr. 18
Dmochwoski’s original testimony for the correct extinction coefficient and 19

8 Jain et al., “Calculated Absorption and Scattering Properties of Gold
Nanoparticles of Different Size, Shape, and Composition: Applications in
Biological Imaging and Biomedicine,” 110 J. Phys. Chem. 7238 (2006)
(Exh. 1012).
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calculation of nanoparticle concentration. In the absence of arguments to the 1
contrary, we are persuaded that the correct conversion of the O.D. measurements 2
reported in Examples 4 and 9 of GHC’s specification do not fall within GHC’s 3
claim term “about 6.6 X 1011 particles per ml.” 4
Instead of arguing that Dr. Tao is wrong, GHC argues that its claim term is 5
supported by the range of concentrations of nanoparticles of at least 1 x 1011 to 6
some value greater than 9.31 x 1011 and by disclosure of at least five data points 7
with that range9 (4.10 x 1011, 4.46 x 1011, 7.77 x 1011, and 8.55 x 1011) in GHC’s 8
specification. (GHC Opp. 1, Paper 222, at 19:21-20:23, citing GHC ’575 appl., 9
Exh. 1024, at ¶¶ 18, 100, 103, and p. 9, Table 1.) According to GHC, because its 10
claimed concentration is encompassed by the range of optical densities disclosed in 11
the specification, one of skill in the art would have recognized that the inventors 12
described the claimed concentration. 13
We are not persuaded by GHC’s argument. “[O]ne skilled in the art, reading 14
the original disclosure, must immediately discern the limitation at issue in the 15
claims.” Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1323 (Fed. Cir. 16
2000). GHC fails to direct us to evidence that one skilled in the art would have 17
understood that the specific concentration of about 6.6 x 1011 is the invention 18
described in GHC’s specification. GHC does not identify any guides, or “blaze 19

9 Although GHC cites to paragraphs 14-66 of Dr. Dmochowski’s Fourth
Declaration, it is not clear from his declaration or GHC’s brief how the five data
points were determined.
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marks,” that would direct one skilled in the art to this particular concentration of 1
nanoparticles. See In re Ruschig, 379 F.2d 990, 994 (C.C.P.A. 1967) (“Specific 2
claims to single compounds require reasonably specific supporting disclosure and 3
while we agree with the appellants, as the board did, that naming is not essential, 4
something more than the disclosure of a class of 1000, or 100, or even 48, 5
compounds is required.”). GHC’s relatively narrow range of “about 6.6 x 1011 6
particles per ml” is not readily discernible in the open-ended range of “at least 1 x 7
1011 to some value greater than 9.31 x 1011” that GHC argues is described in its 8
’575 specification. Compare In re Wertheim, 541 F.2d 257, 265 (C.C.P.A. 1976) 9
(finding sufficient written description for the claim term 35-60% where the 10
specification recites a range of 25-60% along with specific embodiments of 36% 11
and 50%). 12
Accordingly, we find that the limitation “about 6.6. x 1011 particles per ml” 13
is not sufficiently supported by a written description under 35 U.S.C. § 112, first 14
paragraph, in GHC’s specification. 15
C. 16
We also consider Sienna’s arguments regarding the lack of written 17
description for GHC’s claim phrase “unassembled plasmonic nanoparticle.” (See 18
Sienna Motion 1, Paper 84, at 4:25-14:23.) 19
The parties agree that the specification of GHC’s involved ’575 application 20
does not expressly recite the phrase “unassembled plasmonic nanoparticle” or the 21
term “unassembled.” (Sienna Motion 1, Paper 84, at 4:28-29; GHC Opp. 1, 22
Paper 222, at 9:9-10.) Sienna argues that the absence of this term indicates a lack 23
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of express written description support. Sienna argues further that there is no 1
inherent support for the phrase in GHC’s specification. (Sienna Motion 1, 2
Paper 84, at 2:1-13.) 3
To determine if GHC’s specification would convey possession of a method 4
using a composition of “unassembled plasmonic nanoparticles,” we first look to 5
the meaning of that phrase in GHC’s claims. 6
Sienna argues that GHC copied the phrase from Sienna’s claims. (Sienna 7
Motion 1, Paper 84, at 4:30-5:1.) The phrase did not appear in GHC’s claims until 8
GHC filed claims 65-67 (and other claims), which GHC ultimately relied upon to 9
suggest this interference. (See Sienna Motion 1, Paper 84, at 4:29-5:1, citing 10
Supplemental Amendment and Response to Non-Final Office Action, Exh. 1027, 11
at 6-8; see also Suggestion for Declariaton of Interference in GHC’s ’575 appl.) 12
GHC does not dispute that it copied this phrase from Sienna’s claims. 13
Because the phrase was copied, we look to Sienna’s specification for its 14
meaning. See Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1375 (Fed. 15
Cir. 2009) (“[W]hen a party challenges written description support for an 16
interference count or the copied claim in an interference, the originating disclosure 17
provides the meaning of the pertinent claim language.”). (See Sienna Motion 1, 18
Paper 84, at 5:9-11.) Sienna’s specification provides the following discussion: 19
Assembly. 20
The nanoparticles provided herein can generally contain a 21
collection of unassembled nanoparticles. By "unassembled" 22
nanoparticles it is meant that nanoparticles in such a collection are not 23
bound to each other through a physical force or chemical bond either 24
directly (particle-particle) or indirectly through some intermediary 25
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(e.g. particle-cell-particle, particle-protein-particle, particle-analyte-1
particle). In other embodiments, the nanoparticle compositions are 2
assembled into ordered arrays. In particular, such ordered arrays can 3
include any three dimensional array. . . . The nanoparticles are 4
assembled by a van der Walls attraction, a London force, a hydrogen 5
bond, a dipole-dipole interaction, or a covalent bond, or a combination 6
thereof. 7
8
(’941 Spec., Exh. 1004, at 9:39-56 (emphasis added).) According to this passage, 9
Sienna’s specification defines “unassembled” nanoparticles as those not bound to 10
each other by physical forces or chemical bonds (either directly or indirectly 11
through an intermediary). This state is contrasted with nanoparticles that are 12
“assembled.” Assembled nanoparticles are those that are arranged in ordered 13
arrays due to van der Waals or London forces, hydrogen bonds, a dipole-dipole 14
interaction, or a covalent bond. Sienna must prove that GHC’s claims do not 15
describe nanoparticles with no association by physical forces or chemical bonds. 16
Sienna argues that paragraphs 13 and 79 of the GHC specification do not 17
provide a written description of “unassembled plasmonic nanoparticles.” (Sienna 18
Motion 1, Paper 84, at 5:24-14:23.) Sienna notes that GHC cited to paragraphs 13 19
and 79 as support for this claim phrase when it requested an interference. (See 20
GHC 202 Statement, Exh. 1011, App’x D at 1.) 21
Paragraph 13 recites: 22
the invention provides a composition comprising a cosmetically 23
acceptable carrier and a plurality of plasmonic nanoparticles in an 24
amount effective to induce thermomodulation in a target tissue region 25
with which the composition is topically contacted. 26
27
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(GHC ’575 appl., Exh. 1024, at ¶ 13.) Paragraph 79 of the GHC specification 1
states: 2
In another embodiment, nanoshells used are composed of a 120 nm 3
diameter silica core with a 15 [nm]10 thick gold shell, giving a total 4
diameter of 150 nm. The nanoshell is covered by a 5,000 MW PEG 5
[polyethylene glycol] layer. The PEG layer prevents and/or reduces 6
nanoshell aggregation, thereby increasing the nanoshell suspensions 7
stability and shelf-life. 8
9
(’575 appl., Exh. 1024, ¶ 79.) 10
Neither paragraph 13 nor paragraph 79 of GHC’s specification uses the term 11
“unassembled” when referring to nanoparticles. Neither paragraph refers to any 12
physical forces or chemical bonds that would cause nanoparticles to assemble. 13
Paragraph 79 only expresses that the nanoparticles are not “aggregated” due to a 14
PEG layer. 15
Sienna argues that those of skill in the art would have understood that “non-16
aggregated” nanoparticles are not the equivalent of “unassembled” nanoparticles 17
because nanoparticles may be non-aggregated without being unassembled. (Sienna 18
Motion 1, Paper 84, at 6:8-12.) Sienna relies on the testimony of Dr. Tao in 19
support. Dr. Tao testifies that those of skill in the art would have understood 20
aggregated nanoparticles to be the result of forces such as van der Waals or 21

10 Although the text provides for a “15 micron thick gold shell,” it is reasonable
that this measurement should have been 15 nm. (See Second Declaration of Ivan J.
Dmochowski, Exh. 2025, at ¶ 146, FN 35; see also Deposition of Andrea Tao,
Ph.D., Exh. 2114, at 56:3-57:14.)
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London forces only, while assembly is the result of these forces or also dipole-1
dipole interactions, hydrogen bonds, or chemical bonds. (See Tao Decl., 2
Exh. 1002, at ¶¶ 54-59.) The evidence that Dr. Tao cites is not persuasive. For 3
example, Dr. Tao cites to Min11 to show that the scientific literature refers to 4
“aggregation” as the clustering of nanoparticles caused by physical adhesion forces 5
like the van der Waals attraction or London force (Tao Decl., Exh. 1002, at ¶ 60), 6
but Min does not discuss the forces to which non-aggregated nanoparticles are 7
subject. Dr. Tao also provides diagrams and tables to distinguish between “non-8
aggregated” and “unassembled” nanoparticles (see Tao Decl., Exh. 1002, at ¶¶ 57 9
and 59), but this testimony is not supported by references to show that those of 10
skill in the art would have had the same understanding. Thus, Dr. Tao’s testimony 11
does not help us to understand anything about the nanoparticles of GHC’s 12
paragraph 79. Her testimony does not persuade us about the state of assembly of 13
the nanoparticles of GHC’s paragraph 79. 14
Sienna assumes that if the GHC specification does not use the exact 15
language of its claims, support can only be inherent. But the written description 16
requirement does not demand recitation of a claimed invention in haec verba. 17
Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). 18
Instead, “the failure of the specification to specifically mention a limitation that 19
later appears in the claims is not a fatal one when one skilled in the art would 20

11 Min et al., “The role of interparticle and external forces in nanoparticle
assembly,” 7 NATURE MATERIALS 527 (2008)
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recognize upon reading the specification that the new language reflects what the 1
specification shows has been invented.” All Dental Prodx, LLC v. Advantage 2
Dental Products, Inc., 309 F.3d 774, 779 (Fed. Cir. 2002). In All Dental Products 3
the court held that a claim to a method of making a dental mold with the step 4
“heating an original unidentified mass of thermosetting material . . .” was 5
sufficiently described because the description in the specification involved heating 6
a thermoplastic mass that did not have an identifiable form or shape. Even though 7
the words “original unidentified mass” were not recited in the specification, the 8
court’s holding did not rely on an inherent description because those of skill in the 9
art would have understood the lack of a shape from the description. 10
Like the facts of All Dental Products, GHC’s claims recite nanoparticles that 11
lack a structure – assembly. In the absence of evidence that those of skill in the art 12
would know the nanoparticles described in GHC’s specification have this structure, 13
we are not persuaded that it does. Sienna’s evidence directed towards showing that 14
non-aggregated nanoparticles may be assembled does not persuade us that the 15
nanoparticles of paragraph 79 are assembled. (See Tao Decl., Exh. 1002, at ¶¶ 56-16
69.) Even though the exact term “unassembled” does not appear in GHC’s 17
specification, we are not persuaded that the nanoparticles described therein are 18
assembled. Because nanoparticles can be either assembled or unassembled – there 19
being no third choice demonstrated by Sienna – and we have no reason to consider 20
the nanoparticles of paragraph 79 to be assembled, we consider them to be 21
unassembled. 22
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We need not consider Sienna’s arguments regarding inherent disclosure of 1
“unassembled plasmonic nanoparticles” in GHC’s specification (see Sienna 2
Motion 1, Paper 84, at 7:13-14:23) because our determination is not based on an 3
inherent disclosure. Sienna does not give us any reason to find that those of skill in 4
the art would consider the nanoparticles of the GHC specification to be assembled 5
from the express language of the specification. 6
Accordingly, Sienna fails to meet its burden of showing that the limitation 7
“unassembled plasmonic nanoparticles” in GHC’s claims lacks sufficient written 8
description under 35 U.S.C. § 112, first paragraph in GHC’s ’575 application. 9
D. 10
Even though Sienna has failed to persuade us that GHc’s claim term 11
“unassembled plasmonic nanoparticles” lacks written description support, because 12
we find that the term “about 6.6 x 1011 nanoparticles per ml” is not described we 13
hold that claims 65-67 are unpatentable under 35 U.S.C. § 112, first paragraph. 14
15
III. GHC Contingent Motion 4 – To add claim 74 16
A. 17
GHC requests that new claim 74 be added to its involved ’575 application. 18
GHC’s proposed claim 74 is reproduced below, with strikethough font to indicate 19
deleted text and underlining to indicate added text compared to GHC’s currently 20
pending claim 65: 21
A method of localizing thermal damage to a hair follicle, comprising: 22
applying a composition to a skin surface, 23
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wherein said composition comprises a plurality of unassembled 1
plasmonic nanoparticles, 2
wherein the unassembled plasmonic nanoparticles comprise a 3
conductive metal portion, 4
wherein the conductive metal portion comprises gold, 5
wherein the unassembled plasmonic nanoparticles have a diameter of 6
about 150 nm, 7
wherein the unassembled plasmonic nanoparticles comprise a coating 8
that coats the conductive metal portion, wherein said coating facilitates 9
selective removal from the skin surface, 10
wherein the coating comprises polyethylene glycol (PEG), 11
wherein the composition comprising unassembled plasmonic 12
nanoparticles has have a concentration an Optical Density of 250 O.D. when 13
measured at a wavelength of about 810 nm of about 6.6 x 1011 particles per 14
ml of the composition, wherein said composition concentration is sufficient 15
to, after exposure to irradiation, induce thermal damage in the hair follicle; 16
distributing the composition from the skin surface to the hair follicle 17
to target the hair follicle; 18
selectively removing the composition from the skin surface, while 19
leaving the composition localized within the hair follicle; and 20
irradiating the composition with an infrared light source thereby 21
inducing a plurality of surface plasmons in said unassembled plasmonic 22
nanoparticles, wherein the induction of the surface plasmons generates 23
thermal damage to the hair follicle for at least one of hair removal or hair 24
growth reduction. 25
26
(GHC Motion 4, Paper 162, at Appd’x 3A.) Proposed claim 74 deletes the 27
limitation “wherein the unassembled plasmonic nanoparticles have a concentration 28
of about 6.6 x 1011 particles per ml” and replaces it with the limitation “wherein the 29
composition comprising unassembled plasmonic nanoparticles has an Optical 30
Density of 250 O.D. when measured at a wavelengthof about 810 nm.” (See GHC 31
Motion 4, Paper 162, at 5:25-6:1.) 32
Interference 106,037

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B. 1
GHC fails to meet the burden it undertook in seeking to add a new claim to 2
the interference. See 37 C.F.R. § 41.121(b)(“The party filing the motion has the 3
burden of proof to establish that it is entitled to the requested relief.”) When 4
moving to add a claim to an application and the interference, the movant must, 5
among other things, certify that the proposed claim is patentable, show why there 6
would still be an interference-in-fact between the proposed claim and the 7
opponent’s involved claims, and show that the proposed claim corresponds to a 8
count in the interference. (See Standing Order ¶ 208.5.1.) 9
GHC implies it does not have to meet this burden on some issues because 10
the declaration of this interference is an interlocutory finding. (See, e.g., GHC 11
Reply 4, Paper 246, at 2:25-27; 3:24-26; 5:3-7; and 6:15-18.) Similarly, GHC 12
argues that claim 74 must be patentable because GHC was allowed to file Motion 4 13
proposing it. (GHC Reply 4, Paper 246, 1:15-18.) GHC is wrong. A declaration 14
of interference is a rebuttable determination that, in the opinion of the Director, as 15
delegated to an administrative patent judge, claims of a pending application 16
interfere with claims of another application or unexpired patent. (See 35 U.S.C. 17
§ 135(a); see also 37 C.F.R. § 41.203.) Declaration of an interference is not a legal 18
conclusion or finding of fact regarding any issue for which a party assumes the 19
burden. Thus, the declaration of this interference is not a determination of the 20
patentability of proposed claim 74 or of any relationship between GHC’s proposed 21
claim 74 and Sienna’s claims or Count 1. 22
GHC argues that proposed claim 74 interferes with the claims of Sienna’s 23
Interference 106,037

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’941 patent because none of the differences between the claims “creates a 1
patentable distinction.” (GHC Motion 4, paper 162, at 6:22-25.) GHC does a 2
cursory comparison between the claims, noting that proposed claim 74 presents 3
several limitations within the scope of ranges recited in Sienna’s claims. For 4
example, GHC notes that Sienna’s claim 1 recites nanoparticles having a size in 5
the range of 10 nm to 300 nm and GHC’s proposed claim 74 recites nanoparticles 6
having a diameter of about 150 nm. (GHC Motion 4, Paper 162, at 8:12-14.) 7
Similarly, GHC notes that Sienna’s claim 1 recites a “concentration of 109 to 1023 8
nanoparticles per ml of the composition” while GHC’s proposed claim 74 recites 9
“an Optical Density of 250 O.D. when measured at a wavelength of about 810 10
nm.” (GHC Motion 4, Paper 162, at 8:18-21.) GHC argues that for each of these 11
limitations, proposed claim 74 recites “a single member of a class” or a “species” 12
of the scope of the limitation in Sienna’s claim. (GHC Motion 4, Paper 162, at 13
8:5-9.) 14
“An interference exists if the subject matter of a claim of one party would, if 15
prior art, have anticipated or rendered obvious the subject matter of a claim of the 16
opposing party and vice versa.” 37 C.F.R. § 41.203(a). “A claim corresponds to a 17
count if the subject matter of the count, treated as prior art to the claim, would have 18
anticipated or rendered obvious the subject matter of the claim.” 37 C.F.R. 19
§ 41.207(b)(2). Count 1 in this interference is Sienna ’941 patent claim 1. Thus, 20
to show interference-in-fact with Sienna claim 1 or correspondence to Count 1, 21
GHC must show that proposed claim 74 is anticipated or rendered obvious by 22
Sienna claim 1. GHC fails to do so. 23
Interference 106,037

-22-
GHC’s argument that the limtiations of proposed claim 74 “fall within” the 1
limitations of Sienna claim 1 does not show whether GHC’s narrower limitations 2
would have been obvious over the broader limitations. “It is well established that 3
the disclosure of a genus in the prior art is not necessarily a disclosure of every 4
species that is a member of that genus. . . . . There may be many species 5
encompassed within a genus that are not disclosed by a mere disclosure of the 6
genus.” Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006) 7
(citations omitted). Furthermore, “[a] disclosure of millions of compounds does 8
not render obvious a claim to three compounds, particularly when that disclosure 9
indicates a preference leading away from the claimed compounds.” In re Baird, 16 10
F.3d 380, 383 (Fed. Cir. 1994). GHC does not direct us to evidence showing that 11
one of skill in the art would have considered it obvious to have chosen the narrow 12
range of nanoparticle diameter and optical density recited in its proposed claim 74, 13
given the wide ranges recited in Sienna’s claim 1.12 Accordingly, GHC has failed 14
to meet its burden of showing that proposed claim 74 interferes with any of 15
Sienna’s claims. For the same reasons, GHC also fails to meet its burden to show 16
that proposed claim 74 would correspond to Count 1. 17
Furthermore, GHC “certifies” that it is not aware of any reason why 18
claim 74 is not patentable (GHC Motion 4, paper 162, at 4:2-3), but fails to direct 19

12 GHC’s arguments that a composition as recited in proposed claim 74 would
work to induce thermal damage in a hair follicle do not address whether Sienna’s
claim would render obvious proposed claim 74. (See GHC Motion 4, Paper 162, at
9:1-9.)
Interference 106,037

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us to supporting evidence, such as the testimony of a skilled artisan qualified to 1
opine on the relevant prior art. 2
C. 3
Because GHC fails to meet its burden to show that proposed claim 74 is 4
patentable, interferes with any of Sienna’s involved claims, or corresponds to 5
Count 1, we deny GHC Responsive Motion 4. 6
7
III. Conclusion 8
A. 9
We grant Sienna Motion 1, finding that GHC’s claims 65-67 are 10
unpatentable under 35 U.S.C. § 112, first paragraph. 11
We deny GHC Responsive Motion 4, denying GHC’s request to add 12
proposed claim 74 to its involved ’575 application. 13
We deny, in part, GHC Motion 8 to exclude evidence relied upon in our 14
decision. We dismiss as moot GHC’s arguments regarding evidence we do not 15
rely upon. 16
Because we would grant Sienna Motion 1 and deny GHC Motion 4 even if 17
we do not exclude the evidence cited by Sienna in its Motion to Exclude, we 18
dismiss that motion as moot. 19
B. 20
Sienna’s Motion 1, challenging the written description support for GHC’s 21
involved claims, presents the issue of whether GHC has standing in this 22
interference. See 37 C.F.R. § 41.201. 23
Interference 106,037

-24-
Applicant GHC suggested this interference in a statement filed 15 July 2015 1
under 37 C.F.R. § 202(d). The suggestion cited GHC’s ’575 application claims 2
filed 1 January 2015 and Sienna’s ’941 patent claims issued on 2 September 2014. 3
Thus, GHC suggested the interference based on claims that were filed after the 4
issue of Sienna’s patent claims. Because GHC’s interfering claims are not 5
sufficiently supported by its specification, it has no basis on which to challenge the 6
patentability of Sienna’s claims under 35 U.S.C. § 102(g) or any other part of the 7
statute. GHC does not argue to the contrary. As discussed above, in addition to 8
granting Sienna Motion 1, we deny GHC Responsive Motion 4 to add a claim to 9
the interference. Thus, GHC has no claims remaining. 10
Accordingly, Sienna’s remaining motion is moot and we do not consider 11
GHC’s motions challenging Sienna’s involved claims. Cf. Berman v. Housey, 291 12
F.3d 1345, 1351 (Fed. Cir. 2002) (“Accordingly, we hold that § 135(b) is a 13
threshold issue that should be addressed by the Board at the preliminary stage of an 14
interference before proceeding to the merits, and that the Board in this case 15
properly refused to consider Berman's unpatentability motion once it determined 16
that Berman's claim 64 was barred under § 135(b).”). 17
We enter judgment against GHC separately, finally refusing its involved 18
claims and terminating the interference. 19

Interference 106,037

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cc (via e-mail): 1
Attorney for Junior Party General Hospital: 2
3
Peter C. Lauro 4
Brian R. Landry 5
SAUL EWING LLP 6
plauro@saul.com 7
blandry@saul.com 8
9
10
Philippe Bennett 11
Walter Scott 12
ALSTON & BIRD, LLP 13
philippe.bennett@alston.com 14
scott@alston.com 15
16
17
Attorney for Senior Party Sienna: 18
19
Brenton R. Babcock 20
Salima A. Merani 21
Ted M. Cannon 22
KNOBBE, MARTENS, OLSON & BEAR, LLP 23
BoxSienna@knobbe.com 24
25
Michael R. Fleming 26
IRELL & MANELLA LLP 27
MFleming@irell.com 28
29