Ex Parte McNulty et al

Board of Patent Appeals and Interferences

Sep 14, 2010

11764604 (B.P.A.I. Sep. 14, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte AMY K. MCNULTY,
KRISTINE KIESWETTER, and DANIEL C. WADSWORTH JR.
__________

Appeal 2010-003439
Application 11/764,604
Technology Center 1600
__________

Before CAROL A. SPIEGEL, LORA M. GREEN, and
JEFFREY N. FREDMAN, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134 involving claims to using
aptamers to detect bacterial infection and to treating the infection with a
bacteriophage. The Examiner denied priority to a provisional application
and rejected the claims as lacking written descriptive support and as
obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a
civil action, as recited in 37 C.F.R. § 1.304, or for filing a request
for rehearing, as recited in 37 C.F.R. § 41.52, begins to run from
the “MAIL DATE” (paper delivery mode) or the
“NOTIFICATION DATE” (electronic delivery mode) shown on
the PTOL-90A cover letter attached to this decision.
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Statement of the Case
The Claims
Claims 1-33 are on appeal. Claims 1, 5, 7, 16, and 24 are
representative of the argued claims. The remaining claims have
not been argued separately and therefore stand or fall together. 37
C.F.R. § 41.37(c)(1)(vii). Claims 1, 5, 7, 16, and 24 read as
follows:
1. A method of detecting bacteria in an
infection comprising:
(a) obtaining a sample from an infection site
in a subject;
(b) contacting the sample with one or more
bacteria-specific aptamers; and
(c) detecting an interaction between the
bacteria-specific aptamers and bacteria present in
the sample, wherein the bacteria in the infection
are detected.

5. The method of claim 1, wherein the sample
is obtained by aspiration, biopsy, swabbing, or
venipuncture.

7. The method of claim 1, wherein the sample
is contacted with between 10 and 100 different
bacteria-specific aptamers.

16. The method of claim 2, wherein the one or
more bacteria species identified in the sample are
of the genus Pseudomonas.

24. A method for treating a wound comprising:
(a) obtaining a tissue or fluid sample from
the wound;
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(b) contacting the sample with one or more
bacteria-specific aptamers;
(c) detecting an interaction between the
bacteria-specific aptamers and bacteria present in
the sample;
(d) identifying at least one bacteria species
in the sample based on its interaction with the
bacteria-specific aptamers; and
(e) selecting one or more bacteriophage that
infect the identified bacteria species; and
(f) topically administering an effective
amount of the bacteriophage to the wound,
wherein the wound is treated.

The issues
A. The Examiner denied claims 1-33 benefit of the filing date of
provisional US application 60/814,725 for failing to provide support under
35 U.S.C. § 112, first paragraph (Ans. 4-5).
B. The Examiner rejected claims 1-33 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement
(Ans. 5-6).
C. The Examiner rejected claims 1-33 under 35 U.S.C. § 103(a) as
obvious over McVay2, Bunka3, Yang4, and Burrell5 (Ans. 6-9).

2 McVay et al., Phage Therapy of Pseudomonas aeruginosa
Infection in a Mouse Burn Wound Model, 51 ANTIMICROBIAL
AGENTS AND CHEMOTHERAPY 1934-1938 (2007).
3 Bunka et al., Aptamers come of age – at last, 4 NATURE REVIEWS
MICROBIOLOGY 588-596 (2006).
4 Yang et al., Immunofluorescence assay and flow-cytometry
selection of bead-bound aptamers, 31 (E54) NUCLEIC ACIDS
RESEARCH 1-8 (2003).
5 Burrell et al., US 2003/0099718 A1, published May 29, 2003.
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D. The Examiner rejected claims 1-33 under 35 U.S.C. § 103(a) as
obvious over Markoishvili6, Ahmad7, Gorenstein8, Burrell, and Ghanbari9
(Ans. 9-12).
A. Priority to US 60/814, 725
The Examiner finds that “neither the broad, independent claims nor
the narrower, dependent claims are supported by adequate written
description set forth in 35 U.S.C. 112” (Ans. 4). The Examiner finds that the
“broad detection claim (see claim 1 of the instant application) or the broad
treatment claim (see claim 24 of the instant application) requires very
specific method steps that are neither disclosed nor suggested in the
provisional application such as ‘obtaining a sample form [sic] an infection
site in a subject’” (Ans. 4-5).
Appellants contend that “[s]upport for the limitation ‘obtaining a
sample’ is found in the provisional patent application. In particular, it is
taught that ‘the present invention involves the detection and treatment of
bacterial infections.’ Provisional specification at paragraph [0004]” (App.
Br. 3). Appellants contend that “[o]ne of skill in the art would recognize

6 Markoishvili et al., A novel sustained-release matrix based on
biodegradable poly(ester amide)s and impregnated with
bacteriophages and an antibiotic shows promise in management of
infected venous stasis ulcers and other poorly healing wounds, 41
INTERNATIONAL J. DERMATOLOGY 453-458 (2002).
7 Ahmad, S., Treatment of post-burns bacterial infections by
bacteriophages, specifically ubiquitous Pseudomonas spp.
notoriously resistant to antibiotics, 58 MEDICAL HYPOTHESES 327-
331 (2002).
8 Gorenstein et al., US 2006/0121489 A1, published Jun. 8, 2006.
9 Ghanbari et al., US 6,942,858 B1, issued Sep. 13, 2005.
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that incubating the aptamers with the suspected infected solution and
allowing the bacteria to bind their specific aptamers would involve
‘contacting the sample with one or more bacteria-specific aptamers.’” (App.
Br. 4).
Appellants contend that, based on the disclosure of the provisional
application, “it would be clear to one of skill in the art that the sample
obtained from the infection site may contain a wide variety of bacteria that is
to be isolated, contacted, and detected with one or more bacteria-specific
aptamers” (App. Br. 4). Appellants also contend that “one of skill in the art
would recognize that the therapy would include treatment of a skin
infection” (App. Br. 4).
The issue with respect to benefit of priority is: Does the evidence of
record support the Examiner’s conclusion that the disclosure in provisional
application 60/814,725 fails to provide possession of the later claimed
subject matter?
Findings of Fact
1. The first step of Claim 1 is “obtaining a sample from an
infection site in a subject” (Claim 1).
2. Provisional application 60/814,725 teaches that the “present
invention involves the detection and treatment of bacterial infections. The
detection involves identification of bacterial species through the use of
specifically developed aptamers” (60/814,725 2 ¶ 0004).
3. Provisional application 60/814,725 teaches that:
Each type of bacteria-specific aptamer would be coupled to
a bead having slightly different fluorescent properties.
Mixtures of bead / aptamers would then be incubated with
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the suspected infected solution. Bacteria would bind to their
specific aptamers. . . . A classification laser would allow
classification of the bead – aptamer type (i.e.
Staphylococcus aptamer).

(60/814,725 4 ¶ 0008).
4. Provisional application 60/814,725 teaches that “[b]y this
technology up to one hundred or more bacteria may be identified and
quantified during a single analysis” (60/814,725 4 ¶ 0008).
5. Provisional application 60/814,725 teaches that “[o]nce bacteria
are identified, bacteriophage therapy will be initiated . . . [t]he bacteriophage
or bacteriophage cocktail may be applied topically by one of several
methods. These methods include topical emulsions . . . intrapleural
injections, intravenous application, tablets and aerosols” (60/814,725 4 ¶
0009).
Principles of Law
Under the written description requirement of 35 U.S.C. § 112, first
paragraph, the disclosure of the application relied upon must reasonably
convey to the artisan that, as of the filing date of the application, the inventor
had possession of the later-claimed subject matter. Vas-Cath, Inc. v.
Mahurkar, 935 F.2d 1555, 1562-63 (Fed. Cir. 1991).
Under 35 U.S.C. § 120, “in a chain of continuing applications, a claim
in a later application receives the benefit of the filing date of an earlier
application so long as the disclosure in the earlier application meets the
requirements of 35 U.S.C. § 112, ¶ 1, including the written description
requirement, with respect to that claim.” Tech. Licensing Corp. v. Videotek,
Inc., 545 F.3d 1316, 1326 (Fed. Cir. 2008) (citing Transco Prods., Inc. v.
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Performance Contracting, Inc., 38 F.3d 551, 556 (Fed. Cir. 1994)).
“Although § 120 incorporates the requirements of § 112 ¶ 1, these
requirements and the statutory mechanism allowing the benefit of an earlier
filing date are separate provisions with distinct consequences. In accordance
with § 120, claims to subject matter in a later-filed application not supported
by an ancestor application in terms of § 112 ¶ 1 are not invalidated; they
simply do not receive the benefit of the earlier application's filing date.”
Reiffin v. Microsoft Corp., 214 F.3d 1342, 1346 (Fed. Cir. 2000).
Analysis
The relationship of the instant Specification to the provisional
Specification is functionally identical to that of a continuation-in-part, since
the instant Specification adds material to that found in the provisional
Specification. Therefore, the instant claims may have different priority dates
depending upon whether they are supported by the Specification of
provisional application 60/814,725 and the instant Specification or only by
the instant Specification. See Waldemar Link GmbH & Co. v. Osteonics
Corp., 32 F.3d 556, 558 (Fed. Cir. 1994) (“A CIP application can be entitled
to different priority dates for different claims. Claims containing any matter
introduced in the CIP are accorded the filing date of the CIP.”)
The Examiner finds that “neither the broad, independent claims nor
the narrower, dependent claims are supported by adequate written
description set forth in 35 U.S.C. 112” (Ans. 4). In particular, the Examiner
finds that there is no teaching of “obtaining a sample from an infection site
in a subject” as required by Claim 1 or “obtaining a tissue or fluid sample
from the wound” as required by Claim 24 (see Ans. 5).
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We agree with Appellants that in “order to identify the bacteria
present in the infection, it is necessary to obtain a sample from the infection
site” (App. Br. 3). There is no reasonable interpretation of the teaching in
the provisional Application that “[m]ixtures of bead / aptamers would then
be incubated with the suspected infected solution” (60/814,725 2 ¶ 0008; FF
3), other than that a sample was obtained from an infection site. We
therefore agree with Appellants that the provisional specification
demonstrates possession of the invention of Claim 1 and Appellants are
entitled to benefit of priority in provisional 60/814,725.
However, claim 24 stands on different ground, since claim 24 requires
obtaining a sample from “the wound”. There is no disclosure of a “wound”
in provisional 60/814,725, and infections are not necessarily associated with
wounds. While it may be obvious to obtain a sample from a wound to
determine if there is an infection, “a description that merely renders the
invention obvious does not satisfy the [written description] requirement.”
Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed.
Cir. 2010).
Having determined that Claim 24 is not entitled to benefit of priority,
we also conclude that dependent claims 25-33 are also not entitled to benefit
of priority. In fact, all of these dependent claims are drawn to specific
wound types and administration to wounds, and there is no disclosure in the
provisional 60/814,725 of specific wound types or of administration to a
“wound” in particular (see Claims 25-33).
We find that provisional Specification 60/814,725 teaches detection or
quantification using bacteria-specific aptamers of up to 100 different
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bacteria where aptamers are bound to fluorescent beads, detected by flow
cytometry and administering bacteriophage topically and by intrapleural or
intravenous injection (FF 3-5), reasonably providing descriptive support for
claims 2, 3, 6-15, 17, 19-23.
However, we find that provisional Specification 60/814,725 does not
demonstrate possession or descriptive support for skin infections as recited
in claim 4, the particular modes of obtaining sample recited in claim 5, or
identification or treatment of Pseudomonas as recited in claims 16 and 18.
Appellants have not identified any location with specific descriptive support
for these claims (see App. Br. 4). While any of these elements may be
obvious from the Specification of provisional 60/814,725, “a description that
merely renders the invention obvious does not satisfy the [written
description] requirement.” Ariad, 598 F.3d at 1352.
Conclusions of Law
(i) The evidence of record supports the Examiner’s conclusion that
the disclosure in provisional application 60/814,725 fails to provide
possession for claims 4, 5, 16, 18, and 24-33.
(ii) The evidence of record does not support the Examiner’s
conclusion that the disclosure in provisional application 60/814,725 fails to
provide of claims 1-3, 6-15, 17, and 19-23.
B. 35 U.S.C. § 112, first paragraph, written description
The Examiner finds that “the instant specification fails to disclose a
representative number of species encompassed by the genus of any number
of bacteria-specific aptamers, wherein the number is claimed to be up to
‘100 different’ aptamers” (Ans. 6). The Examiner concludes that “the mere
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one paragraph disclosure of ‘how to obtain’ or screen for an aptamer by
using the SELEX process is not a sufficient description for the claimed
diagnostic/treatment methods requiring a genus of any number of bacteria-
specific aptamers and a species of Pseudomonas-specific aptamers” (Ans.
6).
Appellants contend that “the application does not need to teach, and
preferably omits a teaching of, the structures of these well-known bacteria-
specific aptamers” (App. Br. 6). Appellants contend that instant claims 1-33
are not claiming “the bacteria-specific aptamers directly, but are claiming a
method that utilizes bacteria-specific aptamers in general, by using bacteria-
specific aptamers to detect and identify bacteria. Given that such aptamers
were well-known, one of skill in the art could have easily identified
aptamers to use in the claimed method” (App. Br. 6).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that the Specification does not
provide adequate written description of the aptamers of Claims 1 and 24?
Findings of Fact
6. The Specification teaches that “[d]evelopment of aptamers is
typically done through SELEX (Systematic Evolution of Ligands by
Exponential Enrichment) or variations on the SELEX process. The SELEX
process has been described by Turek and Gold, 1990, and in U.S. Patent
Nos. 5,270,163 and 5,475,096” (Spec. 11, ll. 20-23).
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7. Butz10 teaches that “[e]ight peptide aptamers were isolated from
a randomized expression library, which specifically bound to the HBV core
protein under intracellular conditions” (Butz 6579, abstract).
8. Joshi11 teaches that “the ability of each of the 10 selected RNA
aptamers to bind recombinant purified HIV-1 RT was evaluated in vitro via
EMSA [electrophoretic mobility shift assay], and the dissociation constants
were determined for each individual aptamer in its processed form” (Joshi
6548, col. 2).
9. Lorger12 teaches to “verify the surface binding of the aptamers
to live trypanosomes, we performed indirect in situ fluorescence labeling
experiments with internally biotinylated aptamer preparations. . . . After they
bound to live trypanosomes . . . aptamers were detected by incubation with
Alexa Fluor 488-conjugated streptavidin” (Lorger 87, col. 2).
10. Lorger teaches that “these results indicate that the aptamer
RNAs bind to the surface of live trypanosomes” (Lorger 88, col. 1).

10 Butz et al., Peptide aptamers targeting the hepatitis B virus core
protein: a new class of molecules with antiviral activity, 20
ONCOGENE 6579-6586 (2001).
11 Joshi et al., Potent Inhibition of Human Immunodeficiency Virus
Type 1 Replication by Template Analog Reverse Transcriptase
Inhibitors Derived by SELEX (Systematic Evolution of Ligands by
Exponential Enrichment), 76 J. VIROLOGY 6545-6557 (2002).
12 Lorger et al., Targeting the Variable Surface of African
Trypanosomes with Variant Surface Glycoprotein-Specific, Serum-
Stable RNA Aptamers, 2 EUKARYOTIC CELL 84-94 (2003).
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11. Vivekananda13 teaches the use of aptamers “to screen for
pathogens in samples of human tissues or fluids” (Vivekananda, col. 6, ll.
25-26).
12. Vivekananda teaches “nucleic acid ligands capable of binding
to, identifying and/or neutralizing anthrax” (Vivekananda, col. 2, ll. 23-24).
Principles of Law
According to the Federal Circuit,
(1) examples are not necessary to support the adequacy of a
written description[;] (2) the written description standard
may be met … even whe[n] actual reduction to practice of
an invention is absent; and (3) there is no per se rule that an
adequate written description of an invention that involves a
biological macromolecule must contain a recitation of
known structure.

Falko-Gunter Falkner v. Inglis, 448 F.3d 1357, 1366 (Fed. Cir. 2006).
Analysis
While the Examiner correctly notes that the Specification does not
provide specific description of particular aptamers which will bind to
particular bacteria (see Ans. 6), this does not end the written description
inquiry. In Ariad, the court “set forth a number of factors for evaluating the
adequacy of the disclosure [for generic claims], including ‘the existing
knowledge in the particular field, the extent and content of the prior art, the
maturity of the science or technology, [and] the predictability of the aspect at
issue’” Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co.,

13 Vivekananda et al., US 6,569,630 B1, issued May 27, 2003.
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598 F.3d 1336, 1351 (Fed. Cir. 2010) (citing Capon v. Eshhar, 418 F.3d
1349, 1359 (Fed.Cir.2005)).
We conclude, based on the evidence of Butz, Joshi, Lorger,
Vivekananda cited by Appellants as well as Gorenstein cited in an
obviousness rejection by the Examiner, that the state of the prior art in
aptamer technology is mature enough that generic claims to “bacteria-
specific aptamers” as recited in the instant claim 1 are predictable. That is,
while the specific nucleic or amino acid structure of any particular aptamer
which binds to a cognate bacterial protein may be unknown until after the
aptamer is isolated, this is identical to the fact that the specific amino acid
sequence of an antibody which binds to its cognate target is also unknown.
This is not like the situation in Alonzo where a specific antibody to a
specific, unknown, antigen was sought (see In re Alonso, 545 F.3d 1015,
1022 (Fed. Cir. 2008)). In the instant situation, the aptamers are targeted
against well known, prior art antigens found on bacteria, rather than novel,
unknown antigens (see FF 6-12).
Conclusion of Law
The evidence of record does not support the Examiner’s conclusion
that the Specification does not provide adequate written description of the
aptamers of Claims 1 and 24.
C. 35 U.S.C. § 103(a) over McVay, Bunka, Yang, and Burrell
The Examiner finds it obvious to the ordinary artisan “to modify the
Pseudomonas aeruginosa bacteriophage therapy method for a burn wound
of McVay et al. by incorporating aptamer-based detection methods of Bunka
et al. and Yang et al” (Ans. 8).
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Appellants contend that “Bunka et al. and McVay et al. are not prior
art to the presently claimed invention. These cited references were published
in August 2006 and March 2007, respectively, both of which are after the
effective filing date of the current application, which is June 19, 2006” (App.
Br. 7).
Appellants also contend that “[n]one of the references disclose or
suggest the use of aptamers to detect bacteria or the use of aptamers to
detect and identify bacteria in order to identify the appropriate treatment”
(App. Br. 9). Appellants contend that:
Without a suggestion or reason to select the particular
methods currently claimed, these references do not support
an inference of obviousness. Rather, it appears that the
examiner is relying on Appellants’ disclosure as a road map
for selecting and combining elements from the cited
references. The use of such hindsight is not appropriate to
establish a motivation to combine.

(App. Br. 10).
The issues with respect to this rejection are: Do McVay and Bunka
qualify as prior art against each claim on appeal and, if so, does the evidence
of record support the Examiner’s conclusion that McVay, Bunka, Yang, and
Burrell, render obvious the claimed methods?
Findings of Fact
13. Bunka teaches that the “high affinity and specificity of
aptamers make them ideal diagnostic reagents” (Bunka 592, col. 2).
14. Bunka teaches that “‘aptamer beacons’ have many uses, which
range from detecting environmental contaminants to monitoring carcinogen
or drug levels in the blood” (Bunka 592, col. 2).
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15. Yang teaches that “the immunofluorescence-based assay
provides a fast and efficient approach for identifying lead thioaptamers (or
unmodified aptamers) for new agents targeting proteins such as NF-кB”
(Yang 7, col. 1).
16. Yang teaches that a “multi-color flow-cytometry assay could be
easily expanded to multiple proteins and even multiple proteins in cell
proteome extracts. Such an assay could be especially useful in drug
discovery and diagnostics” (Yang 7, col. 1).
17. McVay teaches that “a single dose of phage cocktail can
effectively decrease the rate of mortality due to P. aeruginosa infection of
burn wounds in the mouse model of thermal injury” (McVay 1937, col. 2).
Principles of Law
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). “If a person of
ordinary skill can implement a predictable variation, § 103 likely bars its
patentability.” Id. at 417. Moreover, an “[e]xpress suggestion to substitute
one equivalent for another need not be present to render such substitution
obvious.” In re Fout, 675 F.2d 297, 301 (CCPA 1982). As noted by the
Court in KSR, “[a] person of ordinary skill is also a person of ordinary
creativity, not an automaton.” 550 U.S. at 421.
Analysis
Claims 1-3, 6-15, 17, and 19-23
Having already determined supra that claims 1-3, 6-15, 17, and 19-23
receive benefit of priority to provisional application 60/814,725, we
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necessarily agree with Appellants that for these claims, “McVay and Bunka
are not prior art under 35 U.S.C. § 102 and cannot be used [for] support in
an obviousness rejection under 35 U.S.C. § 103(a)” (App. Br. 8).
Since the rejection relies upon McVay and Bunka, and these
references are not prior art to these claims, we are constrained to reverse the
rejection of McVay, Bunka, Yang, and Burrell as to claims 1-3, 6-15, 17,
and 19-23.
Claims 4, 5, 16, 18, and 24-33
Having already determined supra that claims 4, 5, 16, 18, and 24-33
do not receive benefit of priority to provisional application 60/814,725, we
necessarily agree with the Examiner that McVay and Bunka are prior art to
these claims.
Appellants have not separately argued the claims (see App. Br. 8-10).
We therefore select independent claim 24 as representative. We recognize
that claims 4, 5, 16, and 18 depend from claim 1, but since claim 24
incorporates all of the limitations of claim 1, the analysis for claim 24 will
also address claims 4, 5, 16, and 18 insofar as these claims incorporate the
limitations of claim 1. None of the claims have been argued separately and
therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(vii)
Bunka teaches that the “high affinity and specificity of aptamers make
them ideal diagnostic reagents” (Bunka 592, col. 2; FF 13). Yang teaches
that a “multi-color flow-cytometry assay could be easily expanded to
multiple proteins and even multiple proteins in cell proteome extracts. Such
an assay could be especially useful in drug discovery and diagnostics” (Yang
7, col. 1; FF 16). McVay teaches that “a single dose of phage cocktail can
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effectively decrease the rate of mortality due to P. aeruginosa infection of
burn wounds in the mouse model of thermal injury” (McVay 1937, col. 2;
FF 17).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary creativity would have predictably
diagnosed patients using the aptamer methods of Bunka and Yang (FF 13-
16). Having diagnosed patients with P. aeruginosa infection of burn
wounds, the ordinary artisan would have reasonably applied the effective
phage cocktail treatment method of McVay (FF 17). Such a combination is
merely a “predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. at 417.
Appellants also contend that “[n]one of the references disclose or
suggest the use of aptamers to detect bacteria or the use of aptamers to
detect and identify bacteria in order to identify the appropriate treatment”
(App. Br. 9). Appellants contend that:
Without a suggestion or reason to select the particular
methods currently claimed, these references do not support
an inference of obviousness. Rather, it appears that the
examiner is relying on Appellants’ disclosure as a road map
for selecting and combining elements from the cited
references. The use of such hindsight is not appropriate to
establish a motivation to combine.

(App. Br. 10).
We are not persuaded. While we are fully aware that hindsight bias
often plagues determinations of obviousness, Graham v. John Deere Co.,
383 U.S. at 36, we are also mindful that the Supreme Court has clearly stated
that the “combination of familiar elements according to known methods is
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likely to be obvious when it does no more than yield predictable results,”
KSR, 550 U.S. at 401. This reasoning is applicable, since the instant
invention simply combines the diagnostic use of aptamers taught by Bunka
and Yang with the phage cocktail treatment of patients diagnosed with
particular bacterial infections taught by McVay (FF 13-17). The ordinary
artisan, after diagnosing a bacterial disease, would reasonably have selected
known treatment options such as the phage cocktail of McVay.
Conclusion of Law
(i) Since McVay and Bunka do not qualify as prior art against claims
1-3, 6-15, 17, and 19-23, the evidence of record does not support the
Examiner’s conclusion that McVay, Bunka, Yang, and Burrell, render
obvious claims 1-3, 6-15, 17, and 19-23.
(ii) The evidence of record supports the Examiner’s conclusion that
McVay, Bunka, Yang, and Burrell, render obvious claims 4, 5, 16, 18, and
24-33.
D. 35 U.S.C. § 103(a) over Markoishvili, Ahmad, Gorenstein, Burrell,
and Ghanbari
The Examiner finds that it would “have been obvious to one of
ordinary skill in the art at the time the invention was made to modify the
bacteriophage-mediated wound treatment methods of Markoishvili et al. and
Ahmed by substituting the standard microbiologic techniques of
Markoishvili et al. for the aptamer-based bacteria detection method of
Gore[n]stein” (Ans. 11).
Appellants contend that “there is not a finite number of identified,
predictable methods of detecting bacteria, using aptamers, and treating
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bacterial infections in wounds. Without a suggestion or reason to select the
particular methods currently claimed, these references do not support an
inference of obviousness” (App. Br. 11). Appellants contend that “it appears
that the examiner is relying on Appellants’ disclosure as a road map for
selecting and combining elements from the cited references. The use of such
hindsight is not appropriate to establish a motivation to combine” (App. Br.
12).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Markoishvili, Ahmad,
Gorenstein, Burrell, and Ghanbari render obvious the detection method of
Claim 1 and the combined detection and treatment method of Claim 24?
Findings of Fact
18. Gorenstein teaches “the use of ‘thioaptamers™’ that are
specific for target proteins or other molecules of pathogens. For example,
the thioaptamers . . . may be used to detect, isolate, concentrate, characterize
or even prevent disease by, e.g., a viral, bacterial or other pathogen”
(Gorenstein 2 ¶ 0010).
19. Gorenstein teaches that “the purpose of detecting the interaction
between the specific thioaptamer and the target protein on a pathogen or
pathogen infected cell (or even a transformed cell) may be the presence or
absence of the pathogen in a biological or environmental sample”
(Gorenstein 21 ¶ 0141).
20. Gorenstein teaches that the “aptamers may…bind to pathogens .
. . or toxins such as . . . Pseudomonas A toxins” (Gorenstein 3 ¶ 0019).
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21. Markoishvili teaches “a series of cases, refractory to standard
therapy, that were treated in Tbilisi, Republic of Georgia, using
PhagoBioDerm, a biodegradable polymer that provides [a] slow release of
antibacterial compounds (including specific lytic bacteriophages and
antibiotics) into the wound” (Markoishvili 453, col. 2).
22. Markoishvili teaches that “PhagoBioDerm is the trade name for
a . . . wound dressing prepared as 4 x 5 cm films . . . The films are
impregnated with a mixture of lytic bacteriophages . . . and includes lytic
bacteriophages active against Pseudomonas aeruginosa, Escherichia coli,
Staphylococcus aureus, Streptococcus, and Proteus” (Markoishvili 454, col.
1).
23. Markoishvili teaches that “swab samples were obtained from
the wounds for culture. Potential pathogens were identified and colony
counts enumerated by using standard microbiologic techniques. Micro-
organisms present in the wound were screened for ‘susceptibility’ to
PhagoBioDerm by using a modified disk diffusion method” (Markoishvili
454, col. 1).
24. Markoishvili teaches that in “all instances, colony counts of
presumed pathogens decreased an average of 100-fold after application of
PhagoBioDerm” (Markoishvili 454, col. 2).
25. Ahmad teaches that “[b]ecause it is relatively cheap to produce,
easy to administer, effective at relatively low titre, a minimal number of
applications is required, no known side effects occur, and it is comparatively
safe, the use of bacteriophages in Burns Units specifically in Third Wor[l]d
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countries should prove a valuable tool to combat problems and save lives”
(Ahmad 329, col. 2).
26. Ahmad teaches that “[r]esults have shown that phage therapy
has an 80% success rate against Enterococcus infections and up to 90%
against Staphylococcus aureus, Pseudomonas aeruginosa, Escherichia coli
and Klebsiella pneumoniae” (Ahmad 327, abstract).
27. Ghanbari teaches that the “skilled artisan also is capable of
providing a bacteriophage preparation composition that can be administered
intranasally, rectally, transdermally, topically, or other known routes of
administration of medicaments” (Ghanbari, col. 11, ll. 8-11).
Analysis
Gorenstein teaches the detection of human pathogens with aptamers
(FF 18-20). Markoishvili teaches detecting human pathogens, followed by
treating the infected patient with bacteriophage specific and functional
against the human pathogens (FF 21-24). Ahmad teaches that
bacteriophages are desirable treatments because they are cheap, easy to use,
and low in side effects and functional against pathogens such as
Pseudomonas (see FF 25). Ghanbari teaches that bacteriophages can be
applied topically (FF 27).
Applying the KSR standard of obviousness to the findings of fact, we
conclude that the person of ordinary creativity would have predictably
identified infected patients with the aptamer method of Gorenstein and then
treated infected patients with the bacteriophage therapies of Markoishvili,
Ahmad, and Ghanbari since Ahmad teaches a variety of advantages of this
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approach (FF 25). Such a combination is merely a “predictable use of prior
art elements according to their established functions.” KSR, 550 U.S. at 417.
Appellants contend that “there is not a finite number of identified,
predictable methods of detecting bacteria, using aptamers, and treating
bacterial infections in wounds. Without a suggestion or reason to select the
particular methods currently claimed, these references do not support an
inference of obviousness” (App. Br. 11). Appellants contend that “it appears
that the examiner is relying on Appellants’ disclosure as a road map for
selecting and combining elements from the cited references. The use of such
hindsight is not appropriate to establish a motivation to combine” (App. Br.
12).
We are not persuaded. The Federal Circuit has recognized that
an implicit motivation to combine exists not only when a
suggestion may be gleaned from the prior art as a whole, but
when the “improvement” is technology-independent and the
combination of references results in a product or process that
is more desirable, for example because it is stronger,
cheaper, cleaner, faster, lighter, smaller, more durable, or
more efficient.

DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464
F.3d 1356, 1368 (Fed. Cir. 2006). Gorenstein teaches that “the purpose of
detecting the interaction between the specific thioaptamer and the target
protein on a pathogen or pathogen infected cell (or even a transformed cell)
may be the presence or absence of the pathogen in a biological or
environmental sample” (Gorenstein 21 ¶ 0141; FF 19). Regarding
bacteriophage treatment, Ahmad teaches that “[b]ecause it is relatively
cheap to produce, easy to administer, effective at relatively low titre, a
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minimal number of applications is required, no known side effects occur,
and it is comparatively safe, the use of bacteriophages in Burns Units
specifically in Third Wor[l]d countries should prove a valuable tool to
combat problems and save lives” (Ahmad 329, col. 2; FF 25). These are
specific and credible reasons why the person of ordinary skill would have
incorporated the aptamer detection method and the bacteriophage treatment
method.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Markoishvili, Gorenstein, Burrell, and Ghanbari render obvious the
detection method of Claim 1 and the combined detection and treatment
method of Claim 24.
SUMMARY
In summary, claims 1-3, 6-15, 17, and 19-23 are entitled to benefit
under 35 U.S.C. § 120 of the filing date of US provisional application
60/814,725. Claims 4, 5, 16, 18, and 24-33 are not entitled to benefit under
35 U.S.C. § 120 of the filing date of US provisional application 60/814,725.
We reverse the rejection of claims 1-33 under 35 U.S.C. § 112, first
paragraph as failing to comply with the written description requirement.
We reverse the rejections of claims 1-3, 6-15, 17, and 19-23 under 35
U.S.C. § 103(a) over McVay, Bunka, Yang, and Burrell.
We affirm the rejection of claim 24 under 35 U.S.C. § 103(a) as
obvious over McVay, Bunka, Yang, and Burrell. Pursuant to 37 C.F.R. §
41.37(c)(1)(vii)(2006), we also affirm the rejection of claims 4, 5, 16, 18,
and 24-33 as these claims were not argued separately.
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We affirm the rejection of claims 1 and 24 under 35 U.S.C. § 103(a)
as obvious over Markoishvili, Ahmad, Gorenstein, Burrell, and Ghanbari.
Pursuant to 37 C.F.R. § 41.37(c)(1)(vii)(2006), we also affirm the rejection
of claims 2-23 and 25-33 as these claims were not argued separately.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv)(2006).

AFFIRMED

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