Ex Parte Salamone et al

Patent Trial and Appeal Board

Oct 10, 2017

14504079 (P.T.A.B. Oct. 10, 2017)

United States Patent and Trademark Office
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O.Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
14/504,079 10/01/2014 Joseph Charles SALAMONE F6099-01801 1056
11753 7590 10/10/2017
DUANE MORRIS LLP (prev. Boca Raton)
IP DEPARTMENT
30 SOUTH 17TH STREET
PHILADELPHIA, PA 19103-4196
EXAMINER
ALAWADI, SARAH
ART UNIT PAPER NUMBER
1619
MAIL DATE DELIVERY MODE
10/10/2017 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSEPH CHARLES SALAMONE, KATELYN ELIZABETH
REILLY, RONALD THOMAS NIXON, ANN BEAL SALAMONE, and
KELLY XIAOYU-CHEN LEUNG
Appeal 2017-010448
Application 14/504,079
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to an
antimicrobial, water-insoluble, polymer coating composition. The Examiner
rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
Statement of the Case
Background
This invention relates generally to the treating, reducing,
ameliorating, preventing or inhibiting pathogenic
microorganism ingress to a human or animal host, reducing the
1 Appellants identify the Real Party in Interest as Biotron Limited (see App.
Br. 2).
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potential for infection, particularly by necrotizing fasciitis
originating microorganisms, through use of an antimicrobial
polymer coating barrier that facilitates sustained release of
biocidal agents active against such microorganisms. Such
formulations are effective for inhibiting microbial ingress
pertaining to soft tissue and skin tears, abrasions, punctures and
surgical wounds, and can be used as in water environments and
as a sunscreen and insect repellent.
(Spec. 1:4—10).
The Claims
Claims 1, 6, 8—11, 14—16, 19, and 20 are on appeal. Independent
claim 1 is representative and reads as follows:
1. An antimicrobial, water-insoluble, polymer coating
composition comprising:
poly(hexamethylene biguanide), one or more salts of
poly(hexamethylene biguanide), or combinations thereof in an
amount from at least 1.0 wt-% to 10.00 wt-%,
an antimicrobial composition comprising 0.60 wt-% to
10.00 wt of glycerol monolaurate, and
said water-insoluble, polymer coating composition
comprising up to 98.4 wt-% of a water-insoluble, polymer
coating,
wherein all weight percentages are based on the total
weight of the antimicrobial, water-insoluble, polymer coating
composition,
wherein said water-insoluble, polymer coating
composition provides a log reduction of at least 2 log orders at
48 hours against at least one opportunistic pathogens that
causes necrotizing fasciitis selected from the group consisting
of Vibrio vulnificus and Streptococcus pyrogenes.
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The Issues
A. The Examiner rejected claims 1, 6, 9-11, 14—16, 19, and 20 under 35
U.S.C. § 103 as obvious over Hammer ’812,2 Diversified,3 Ethanol SDA,4
Hammer ’244,5 and Salamone6 (Final Act. 3—8).
B. The Examiner rejected claim 8 under 35 U.S.C. § 103 as obvious over
Hammer ’812, Diversified, Ethanol SDA, Hammer ’244, Salamone, and
Grant7 (Final Act. 8—9).
A. U.S.C. § 103 over Hammer ’812, Diversified, Ethanol SDA, Hammer
’244, and Salamone
The Examiner finds Hammer ’812 “teaches skin coating compositions
which comprises water insoluble polymers, including methacrylate
polymers” that may “be present from 1-40% by weight” and may “include
ethanol. . . from 45-95%” (Final Act. 4). The Examiner finds Hammer ’812
further teaches active agents including “antimicrobial agents such as
polyhexamethylene biguanide” where the “composition can serve as a
2 Hammer, US 2012/0115812 Al, published May 10, 2012 (“Hammer
’812”).
3 Diversified CPC International, Inc., “An Introduction to Aerosol
Propellants,” http://www.diversifiedcpc.com/PDF/intro.pdf, 1—2, 48—52
(undated) (“Diversified”).
4 Ethanol SDA 40B 200, http://products.saslive.dev.atcsp.co.za/sites/default/
files/datasheets/EthanolSDA40B200Ver5a-pending.pdf (Nov. 5, 2013)
(“Ethanol SDA”).
5 Hammer, US 2011/0076244 Al, published Mar. 31, 2011 (“Hammer
’244”).
6 Salamone et al., US 2013/0150451 Al, published June 13, 2013
(“Salamone”).
7 Grant, EP 0612518 Bl, published Sept. 17, 1997 (“Grant”).
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barrier against microorganisms to protect the skin surface and can remain on
the skin for 24 hours” (id. 5).
The Examiner acknowledges Hammer ’812 does not teach “a
combination of polyhexamethylene biguanide with a second antimicrobial
agent (the elected monacyl or monoalkyl glycol of glycerol monolaurate)
present from 0.60-10% by weight or the hydrochloride form of
polyhexamethylene biguanide (PHMB)” (Final Act. 5).
The Examiner finds Salamone teaches “antimicrobial compositions
which exhibit a synergistic interaction of polymeric biguanide with at least
one antimicrobial diol comprising monoalkyl or monoacyl glycerol” (id.).
The Examiner finds it obvious to use Salamone’s antimicrobial
compositions in Hammer’s antimicrobial coating because “Salamone teaches
that polyhexamethylene biguanide with antimicrobial diols including
glycerol monolaurate are highly effective in reduction and elimination of
microbial biofilms and provide synergy” (id.).
The issues with respect to this rejection are:
(i) Does the evidence of record support the Examiner’s conclusion
that the prior art renders claims 1 and 14 obvious?
(ii) If so, have Appellants presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness?
Findings of Fact
1. Hammer ’812 teaches “the coating compositions and methods
may be used for . . . antimicrobial and/or antiviral applications” (Hammer
’812111).
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2. Hammer ’812 teaches “the coating composition includes a
polymer ... a polymer may comprise a methacrylate (i.e.,
butylmethacrylate, n-butylmethacrylate” (Hammer ’812 113).
3. Hammer ’812 teaches: “Antimicrobial agents include . . .
polyhexamethylene biguanide (PHMB)” (Hammer ’812 | 65).
4. Hammer ’812 teaches the “amount of active agent that can be
combined with a coating composition . . . will range from about 1 % to about
99% of active ingredient” (Hammer ’812 | 59).
5. In response to a Restriction Requirement (03/10/2015),
Appellants elected8 poly(hexamethylene biguanide), monoacyl glycerol
(glycerol monolaurate), sunscreen agents, sodium lauriminodipropionate (for
claim 8), lemon eucalyptus, acrylate polymers, and polar solvents (e.g.
ethanol) (see Resp. Restriction Req. 1 (4/13/2015).
6. Hammer ’812 teaches the composition may comprise sunscreen
agents where “the skin protectant may be a sunscreen, such as titanium
dioxide, zinc oxide” (Hammer ’812 137).
7. Hammer ’812 teaches: “Suitable insect repellents include, but
are not limited to . . . lemon eucalyptus” (Hammer ’812 139).
8. Hammer ’812 teaches “suitable organic solvents include
alcohols (i.e., methanol, ethanol[)]” (Hammer ’812 126).
9. Hammer ’812 teaches
the coating may form a barrier that is essentially impermeable
to microorganisms for a period of time. For example, the
barrier may be impermeable to microorganisms for . . . at least
8 We limit our consideration of the merits of the appealed rejection to the
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987).
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48 hours, or at least one week. It should be understood that
even greater periods of time may be attainable.
(Hammer ’812122).
10. Salamone teaches “an antimicrobial composition that is capable
of either reducing a microbial biofilm by 4 log orders in 10 minutes and by
elimination of the biofilm with no regrowth within 24 hours” (Salamone
124) .
11. Salamone teaches an “antimicrobial composition exhibiting a
synergistic interaction of at least one polymeric biguanide and at least one
antimicrobial vicinal dial, where the vicinal dial comprises at least one
monoalkyl glycol, monoalkyl glycerol, or monoacyl glycerol” (Salamone
125) .
12. Salamone teaches: “Exemplary monoacyl glycerols include, but
are not limited to . . . glycerol monolaurate” (Salamone 178).
13. Salamone teaches the “antimicrobial composition can include
the biocidal monoalkyl glycol, glycerol alkyl ether, and monoacyl glycerol
at a combined concentration of from 0.05 wt% (500 ppm) to 4 wt% ( 4,000
ppm)” (Salamone 1 63).
14. Salamone teaches to “include biocidal polymeric biguanides at
a concentration ranging from 0.05 wt% (500ppm) to [10] weight [%]
(10,000 ppm)” (Salamone 1 62).
15. Table 1 of Salamone teaches solution 4, which comprises 1,000
ppm (0.1% by weight) PHMB, 0.3 wt% SC50 and 0.1 wt% SC 10 and
solution 12, which comprises 1,500 ppm (0.15% by weight) PHMB, 0.3%
SC50 and 0.1% SC10 (Salamone 1118).
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16. Salamone teaches: “Solutions 4, 5, and 12 had no error bars,
indicating total eradication of the Pseudomonas aeruginosa biofilm”
(Salamone 1124).
17. Salamone teaches “the superior results of the PHMB
antimicrobial compositions with Sensiva® SC 50 and Sensiva® SC 10
against Gram negative Pseudomonas aeruginosa biofilms are quite
surprising and further demonstrate the synergistic biocidal interaction
between a polymeric biguanide and the vicinal diols” (Salamone 1127;
emphasis added).
18. Salamone teaches the “solubility of glycerol monolaurate was
enhanced by the combination of surfactant, Sensiva® SC 50 and Sensiva®
SC 10” (Salamone 1136).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007).
Prima facie obviousness can be rebutted by presenting evidence of
secondary considerations and when such evidence is submitted, all of the
evidence must be considered anew. In re Piasecki, 745 F.2d 1468, 1472—
1473 (Fed. Cir. 1984).
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Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Rej. 3—8; FF 1—18) and agree that
the claims are obvious over Hammer ’812, Diversified, Ethanol SDA,
Hammer ’244, and Salamone. We address Appellants’ arguments below.
Claim Interpretation
We begin with claim interpretation because before a claim is properly
interpreted, its scope cannot be compared to the prior art. Independent
claims 1 and 14 recite a “wherein” clause that requires the composition to
have the capacity to reduce Vibrio vulnificus and Streptococcus pyrogenes
levels by 2 log orders at 48 hours. We agree with Appellants that, consistent
with Griffin v. Bertina, 283 F.3d 1029, 1034 (Fed. Cir. 2002), the “wherein”
clauses in claims 1 and 14 receive weight (see App. Br. 15).
Prima Facie Obviousness
However, even if the “wherein” clauses receive weight, if the
Examiner reasonably demonstrates that a composition that is obvious for
other reasons would also necessarily and inherently satisfy the “wherein”
clauses, that composition remains prima facie obvious. “We have
recognized that inherency may supply a missing claim limitation in an
obviousness analysis. . . . [T]he concept of inherency must be limited when
applied to obviousness, and is present only when the limitation at issue is the
‘natural result’ of the combination of prior art elements.” Par Pharm., Inc.
v. TWIPharm. Inc., 773 F.3d 1186, 1194—1195 (Fed. Cir. 2014).
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In the present case, the combination of Salamone and Hammer
renders the composition of claims 1 and 14 prima facie obvious, and
therefore also reasonably inherently satisfies the “wherein” clauses.
Specifically, Salamone teaches actual compositions, solutions 4 and
12, which comprise either 0.10 or 0.15% PHMB with 0.3% glycerol
monolaurate (FF 15). Salamone teaches a range for PHMB from 0.05 wt%
(500ppm) to [10] weight [%] (10,000 ppm) that fully overlaps the 0.3 to 1.0
wt% range in claim 14 (FF 14) and a range of glycerol monolaurate from
0.05 wt% (500 ppm) to 4 wt% ( 4,000 ppm) that fully overlaps the 0.2 to 4
wt% range in claim 14 (FF 12—13). See In re Peterson, 315 F.3d at 1329
(“In cases involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness.”)
Salamone explains that these solutions are “capable of either reducing
a microbial biofilm by 4 log orders in 10 minutes and by elimination of the
biofilm with no regrowth within 24 hours” (FF 10). Salamone exemplifies
that solutions 4 and 12 resulted in “total eradication of the Pseudomonas
aeruginosa biofilm” (FF 16).
Hammer teaches that antimicrobial compositions, a genus including
the compositions of Salamone, may include polymers (FF 1—2) and active
agents including PHMB (FF 3) and provides reasons to include the polymers
because the resulting compostion may function for “48 hours, or at least one
week” (FF 9).
Thus, the ordinary artisan, interested in improving antimicrobial
compositions to increase duration of effect, would have had reason to
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incorporate the polymers and PHMB active agent of Hammer into the
biofilm treating compositions of Salamone because the combined “coating
provides sustained release of the active for at least 24 hours” (Final Act. 5)
and because “polyhexamethylene biguanide with antimicrobial diols
including glycerol monolaurate are highly effective in reduction and
elimination of microbial biofilms and provide synergy” (id. at 6).
We therefore find unpersuasive Appellants’ argument that
the rejection completely ignores the claim language related to
the polymer coating formed from the antimicrobial, liquid
coating composition, which provides a log reduction of at least
2 log orders at 48 hours against at least one opportunistic
pathogen that causes necrotizing fasciitis selected from the
group consisting of Vibrio vulnificus and Streptococcus
pyogenes.
(App. Br. 13). The Examiner finds the prior art reasonably suggests
compositions of claims 1 and 14 containing the structural components
required by the claims but is silent with regard to the “wherein” clause.
However:
Where, as here, the claimed and prior art products are identical
or substantially identical... the PTO can require an
[Ajpplicant to prove that the prior art products do not
necessarily or inherently possess the characteristics of his
claimed product. . .Whether the rejection is based on
‘inherency’ under 35 U.S.C. § 102, on ‘prima facie
obviousness’ under 35 U.S.C. § 103, jointly or alternatively, the
burden of proof is the same, and its fairness is evidenced by the
PTO’s inability to manufacture products or to obtain and
compare prior art products.
In re Best, 562 F.2d 1252, 1255 (CCPA 1977).
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As will be discussed infra, we do not find the bare statement in the
Salamone Declaration9 persuasive that the prima facie obvious composition
inherently fails to satisfy the “wherein” clause requirements, particularly in
light of the disclosure of the Specification that sample 8a, which is
composed of elements that only require suggestion from Hammer alone, had
efficacy against Vibrio vulnificus (see Spec. 43, Table 7). We therefore find
the Examiner has reasonably established an inherency position with a
composition that necessarily would have efficacy against Vibrio vulnificus.
Appellants contend “Salamone ’451 expressly states that the
compositions described therein can include at most 0.1 wt% glycerol
monolaurate because even slightly higher concentrations cause the glycerol
monolaurate to precipitate into needle-like crystals” (App. Br. 6—7).
We do not find this argument persuasive because Salamone teaches a
range of monoacyl glycerol concentrations from 0.05 to 4 wt% (FF 13),
including glycerol monolaurate (FF 12), and claims a range of 0.05 to 6 wt%
vicinal diols (see Salamone, claim 2) that include glycerol monolaurate (see
Salamone, claim 12). Moreover, even in the portion cited by Appellants, the
“solubility of glycerol monolaurate was enhanced by the combination of
surfactant, Sensiva® SC 50 and Sensiva® SC 10” (FF 18), reasonably
suggesting “that the monoacyl glycerols (of which Salamone teaches include
glycerol monolaurate) can be present individually and in concentration of
.05-6% by weight with the polymeric biguanides (of which include
polyhexamethylene biguanide)” (Ans. 5).
9 Declaration of Dr. Joseph C. Salamone, dated Aug. 5, 2016.
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Appellants contend that, in “the Salamone Declaration, Dr. Salamone
explained that Salamone ’451 is directed to aqueous mixtures, that glycerol
monolaurate is essentially insoluble in aqueous mixtures, and that the
maximum amount of glycerol monolaurate that his laboratory was able to
dissolve in water was 0.1 wt.%, which was only possible by using
surfactants” (App. Br. 7). Therefore, Appellants contend that “when read in
view of the specification, independent claim 14 is relates to a ‘non-aqueous’
liquid composition, which is distinct from Salamone ’451, which
characterizes its compositions as aqueous compositions” {Id. at 8).
We find this argument unpersuasive because, as the Examiner points
out, the rejection is based on the combination of Hammer and Salamone, not
Salamone alone as an anticipation reference (see Ans. 6). Hammer
expressly teaches polymer compositions (FF 2) that incorporate organic
solvents (FF 8), as well as the use of PHMB as an active agent in
overlapping range amounts (FF 3—4). While Hammer does not teach vicinal
diols such as glycerol monolaurate, Salamone teaches a “synergistic biocidal
interaction between a polymeric biguanide and the vicinal diols” (FF 18).
Consequently, an ordinary artisan would have had good reason to add the
vicinal diol, glycerol monolaurate, into the antimicrobial composition of
Hammer, in order to obtain the synergistic activity against bacterial biofilms
(FF 18). Because Hammer’s compositions are “non-aqueous”, the solubility
concerns identified by Appellants and the Salamone Declaration do not
apply when the references are properly combined because Hammer’s
solution is non-aqueous (see App. Br. 7, Salamone Decl. 14).
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Appellants contend the “evidence of record shows that one of ordinary
skill in the art would not have had a reasonable expectation of success
because the compositions in Salamone ’451 do not meet the recitations in
the wherein clause of independent claim 14” (App. Br. 9). Appellants cite to
the Salamone Declaration, which states “over a four day study, we observed
that solution 4 of Salamone ’451 exhibited no activity against Vibrio’ '’
(Salamone Decl. 14).
We do not find this argument persuasive because there is no
indication that the testing performed on solution 4 in the Salamone
Declaration was performed using conditions similar to those disclosed for
the inventive compositions in the Specification or those used in Salamone.
“The Board has broad discretion as to the weight to give to declarations
offered in the course of prosecution . . . [and] the Board is entitled to weigh
the declarations and conclude that the lack of factual corroboration warrants
discounting the opinions expressed in the declarations.” In re Am. Acad.
Science Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004).
Indeed, because the Salamone Declaration is entirely silent on
precisely what specific tests were performed, it is impossible to evaluate the
data for persuasiveness because differences in testing procedures impact
what results are obtained. There can be no reasonable doubt that there
would be a very reasonable expectation of success in forming the product
rendered obvious by Hammer and Salamone.
In addition, Appellants’ own Specification shows different testing
procedures for analysis of activity against Vibrio, such as “Zone of
Inhibition (ZOI) analysis” (Spec. 36:22—34) and “Log Reduction” data
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(Spec. 37:13 to 38:20). Table 7 of the Specification shows that sample 8a,
which contained only PHMB and did not contain glycerol monolaurate,
showed a 0.70 zone of inhibition while sample 11a, which included
alexidine dihydrochloride, was identified as “highly effective” even though
the zone of inhibition only increased to 1.10, which is similar to the zone of
inhibition increase (to 1.50) achieved by glycerol monolaurate (see Spec.
42:10 to 43:9). Thus, one Specification test showed that a sample consistent
with the composition suggested, though not exemplified, by Hammer alone
(see FF 1—4), comprising only PHMB and polymer, was effective against
Vibrio vulnificus (see Spec. 43, Table 7). This supports the Examiner’s
reasoning that the composition rendered obvious by Hammer and Salamone
that further comprises the synergistic vicinal diols such as glycerol
monolaurate (FF 16), would have necessarily shared this efficacy against
Vibrio vulnificus.
Thus, without specific details regarding the procedure used in the
Salamone Declaration to evaluate solution 4 of Salamone (or the slightly
closer solution 12 of Salamone), we do not find the statement in paragraph 4
of the Salamone Declaration persuasive without factual corroboration
showing experimental data.
Appellants also contend the skilled person
would consider Hammer-2012 to be a skin coating disclosure
providing no relevant guidance as to the agents, active or
otherwise, that may be added thereto. These basic facts alone
demonstrate that it is a gross mischaracterization to suggest that
Hammer-2012 is a disclosure related to coatings containing
polyhexamethylene biguanide that is only lacking a disclosure
of glycerol monolaurate.
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(Reply Br. 4).
We find this argument unpersuasive because Hammer clearly teaches
applications including antimicrobial applications (FF 1), where the coating
comprises an acrylate polymer (FF 2) combined with active antimicrobial
agents such as PHMB (FF 3) in overlapping amounts (FF 4). Hammer is
clearly analogous art in the same field of endeavor as Salamone which is
also drawn to antimicrobial compositions (FF 11) that comprise PHMB in
overlapping amounts (FF 12, 14) with the further synergistic inclusion of
glycerol monolaurate (FF 11, 17).
The test for non-analogous art is first whether the art is within the
field of the inventor’s endeavor and, if not, whether it is “reasonably
pertinent to the particular problem with which the inventor was involved.”
In re Wood, 599 F.2d 1032, 1036 (CCPA 1979). Here, Hammer is within
the field of endeavor, anti-microbial compositions, and is also pertinent to
the issues of designing “coating compositions and methods [that] may be
used for . . . antimicrobial and/or antiviral applications” (FF 1).
We recognize, but find unpersuasive, Appellants’ argument that
“Hammer-2012 does not provide any motivation to select
polyhexamethylene biguanide from the millions of possible agents that can
be included in Hammer-2012 ’s surface coatings for skin” (Reply Br. 4).
Hammer specifically includes PHMB in a relatively short list of
antimicrobial agents (FF 3; see Hammer ’812 165).
For the purposes of whether they are anticipatory, lists and
genera are often treated differently under our case law.
Compare Perricone v. Medicis Pharm. Corp., 432 F.3d 1368,
1376 (Fed.Cir.2005) (rejecting “the notion that [a compound]
cannot anticipate because it appears without special emphasis in
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a longer list”) with Atofina v. Great Lakes Chem. Corp., 441
F.3d 991, 999 (Fed.Cir. 2006) (“It is well established that the
disclosure of a genus in the prior art is not necessarily a
disclosure of every species that is a member of that genus.”).
In re Gleave, 560 F.3d 1331, 1337 (Fed. Cir. 2009). Here, where the issue is
obviousness, not anticipation, we find that selection of a known
antimicrobial agent from a limited list of named choices would have been
obvious. This reasoning is consistent with Wrigley, which found a “strong
case of obviousness based on the prior art references of record. [The claim]
recites a combination of elements that were all known in the prior art, and all
that was required to obtain that combination was to substitute one well-
known . . . agent for another.” Wm. Wrigley Jr. Co. v. Cadbury Adams USA
LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012).
Secondary Considerations
Appellants contend
both the Specification and the Salamone Declaration shows that
the claimed compositions possess unexpected and superior
activity against Vibrio vulnificus and Streptococcus pyogenes,
as compared to the compositions in Salamone ’451. Further,
independent claim 14 goes one step further by expressly
requiring the unexpected and superior activity against Vibrio
vulnificus and Streptococcus pyogenes.
(App. Br. 14).
We find this argument unpersuasive. Salamone suggests a
“synergistic biocidal interaction between a polymeric biguanide and the
vicinal diols” (FF 17), suggesting that the claimed result of the combination
would have been expected, not unexpected. See In re Skoner, 517 F.2d 947,
950 (CCPA 1975) (“Expected beneficial results are evidence of obviousness
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of a claimed invention.”) Moreover, “[i]t is not enough to show that results
are obtained which differ from those obtained in the prior art: that difference
must be shown to be an unexpected difference.” In re Klosak, 455 F.2d
1077, 1080 (CCPA 1972). Here, Appellants do not meet that standard
because no comparison was performed between one of solutions 16 to 21 of
Salamone, which comprise PHMB and glycerol monolaurate in aqueous
solution in lower amounts than those claimed, and the higher amounts in
polymer form required by the claims.
Not only have Appellants not provided data showing a direct
comparison of the closest prior art to demonstrate improved efficacy against
Vibrio vulnificus (or shown that the prior art compositions entirely lack
efficacy against Vibrio vulnificus), but Appellants have not provided a
comparison of solution 4, solution 12, or solutions 16 to 21 of Salamone
with any of the inventive compositions.10 See In re Baxter Travenol Labs.,
952 F.2d 388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as
evidence of nonobviousness, the results must be shown to be unexpected
compared with the closest prior art.”).
We recognize, but find unpersuasive, Appellants’ contention that the
“Examiner mischaracterized the Salamone Declaration as an expert
declaration and accorded it little to no weight due to unsubstantiated
10 We note, as guidance for the Examiner, that evidence comparing each of
the various solutions of Salamone with a range of inventive preparations
with different polymers and the low end and a higher end point of the
claimed ratios of PHMB and glycerol monolaurate may very well be
dispositive of unexpected results. However, currently, no such comparative
results are of record.
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allegations of bias” (App. Br. 16). The Examiner did consider the Salamone
Declaration, but found “the Declaration did not establish any evidence that
the prior art is in fact unobvious” (Ans. 16). Moreover, as already discussed
supra, while we recognize the expertise of Dr. Salamone, a persuasive
Declaration for unexpected results requires supporting evidence
demonstrating (i) the result is, in fact, unexpected; (ii) that the result is
commensurate in scope with the claim; (iii) that the result has been
compared to the closest prior art; and (iv) that any improved properties
represent a difference in kind, rather than simply degree, and not simply
unsupported statements of fact that are not reviewable and that cannot be
analyzed for comparison with the prior art. “It is within the discretion of the
trier of fact to give each item of evidence such weight as it feels
appropriate.” Velanderv. Garner, 348 F.3d 1359, 1371 (Fed. Cir. 2003);
See Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294
(Fed.Cir.1985) (“Fack of factual support for expert opinion going to factual
determinations, however, may render the testimony of little probative value
in a validity determination.”)
Conclusions of Law
(i) The evidence of record supports the Examiner’s conclusion that
the prior art renders claims 1 and 14 obvious.
(ii) Appellants have not presented evidence of secondary
considerations, that when weighed with the evidence of obviousness, is
sufficient to support a conclusion of non-obviousness.
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Appeal 2017-010448
Application 14/504,079
B. U.S.C. § 103 over Hammer ’812, Diversified, Ethanol SDA, Hammer
’244, Salamone and Grant
Appellants do not separately argue this rejection. The Examiner
provides sound fact-based reasoning explaining why the further combination
of Grant with Hammer ’812, Diversified, Ethanol SDA, Hammer ’244, and
Salamone renders the rejected claims obvious (see Final Act. 8—9). Having
affirmed the rejection of claims 1 and 14 over Hammer ’812, Diversified,
Ethanol SDA, Hammer ’244, and Salamone for the reasons above, we affirm
the rejection of claim 8 for the Examiner’s reasons.
SUMMARY
In summary, we affirm the rejection of claims 1 and 14 under 35
U.S.C. § 103 as obvious over Hammer ’812, Diversified, Ethanol SDA,
Hammer ’244, and Salamone. Claims 6, 9—11, 15, 16, 19, and 20 fall with
claim 1.
We affirm the rejection of claim 8 under 35 U.S.C. § 103 as obvious
over Hammer ’812, Diversified, Ethanol SDA, Hammer ’244, Salamone,
and Grant.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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