Ex Parte Blizzard

Patent Trial and Appeal Board

Jan 14, 2019

14115276 (P.T.A.B. Jan. 14, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/115,276 11/01/2013
23859 7590 01/16/2019
Ballard Spahr LLP
SUITE 1000
999 PEACHTREE STREET
ATLANTA, GA 30309-3915
FIRST NAMED INVENTOR
John D. Blizzard
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
37461.0001U2 8408
EXAMINER
KARPINSKI, LUKE E
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
01/16/2019 ELECTRONIC
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.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
USpatentmail@ballardspahr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN D. BLIZZARD
Appeal 2017-011206
Application 14/115,276
Technology Center 1600
Before JEFFREY N. FRED MAN, MICHAEL J. FITZPATRICK, and
RYAN H. FLAX, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1,2 under 35 U.S.C. § 134 involving claims to a
siloxane gel composition. The Examiner rejected the claims as obvious
under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b ). We
affirm.
1 Appellant identifies the Real Parties in Interest as "Quadsil, Inc., ... and its
licensee, Kimmerling Holdings Group LLC" (see Br. 2).
2 We have considered and herein refer to the Specification of Nov. 1, 2013
("Spec."); Final Office Action of Sept. 6, 2016 ("Final Act."); Appeal Brief
of Mar. 13, 2017 ("Br."); and Examiner's Answer of June 16, 2017 ("Ans.").
Appeal 2017-011206
Application 14/115,276
Statement of the Case
Background
"The material of this invention is a siloxane polymer thixotropic base
that is useful as an excipient for many actives or variable materials that can
be compounded into it" (Spec. ,r 2). "'Actives' for purposes of this
invention means any material that will provide a benefit to a user, such as
medicaments ( e.g., triple antibiotic), pharmaceuticals ( e.g., acetylsalicylic
acid), cosmetics (e.g., colorants for the skin), and the like." (Spec. ,r 2).
The Claims
Claims 1, 6, 7, 10-30, and 45 are on appeal. Claims 1 and 7 are
representative and read as follows:
1. A composition, comprising:
A. a siloxane gel comprising:
a. a first solvent selected from the group consisting of:
methylsiloxane cyclics having 4 and 5 silicon atoms, a
trimethylsiloxy end-blocked polydimethylsiloxane, ester of
aromatic alkoxylated alcohol and fatty carboxylic acid,
alkoxylated derivatives ofbenzyl alcohol, aromatic
hydrocarbons, aliphatic hydrocarbons, alcohols, aldehydes,
ketones, amines, esters, ethers, glycols, glycol ethers, alkyl
halides, aromatic halides, and mixtures thereof;
b. a siloxane copolymer comprising a reaction product of:
1. an hydridopolysiloxane selected from the group
consisting of:
(a) R3SiO(R' 2SiO)a(R"HSiO)bSiR3;
(b) HR2SiO(R' 2SiO)cSiR2H; and
( c) HR2SiO(R' 2SiO)a(R"HSiO)bSiR2H;
wherein:
R, R', R" are, each independently, C1-C6alkyl;
a is about Oto about 250;
bis about 1 to about 250; and
c is about Oto about 250; and
11. an a, m-diene having the general formula:
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Application 14/115,276
CH2=CH( CH2)xCH =CH2
wherein:
xis about 1 to about 20;
B. a first additional solvent selected from the group
consisting of: methylsiloxane cyclics having 4 and 5
silicon atoms, a trimethylsiloxy endblocked
polydimethylsiloxane, ester of aromatic alkoxylated
alcohol and fatty carboxylic acid, alkoxylated derivatives
ofbenzyl alcohol, aromatic hydrocarbons, aliphatic
hydrocarbons, alcohols, aldehydes, ketones, amines,
esters, ethers, glycols, glycol ethers, alkyl halides,
aromatic halides, acetonitrile, nitromethane,
dimethylforamide, propylene oxide, trioctyl phosphate,
butyrolactone, furfural, pine oil, turpentine, m-creosol,
volatile flavoring compound, volatile fragrance
compound, and mixtures thereof; and
C. a second additional solvent selected from the group
consisting of: methylsiloxane cyclics having 4 and 5
silicon atoms, a trimethylsiloxy endblocked
polydimethylsiloxane, ester of aromatic alkoxylated
alcohol and fatty carboxylic acid, alkoxylated derivatives
of benzyl alcohol, aromatic hydrocarbons, aliphatic
hydrocarbons, alcohols, aldehydes, ketones, amines,
esters, ethers, glycols, glycol ethers, alkyl halides,
aromatic halides, acetonitrile, nitromethane,
dimethylforamide, propylene oxide, trioctyl phosphate,
butyrolactone, furfural, pine oil, turpentine, m-creosol,
volatile flavoring compound, volatile fragrance
compound, and mixtures thereof; and
D. at least one antimicrobial agent;
wherein said antimicrobial agent is a silicon-
containing antimicrobial agent.
7. A composition of claim 1,
wherein said at least one antimicrobial agent is 3-
(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride.
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Application 14/115,276
The Rejections
A. The Examiner rejected claims 1, 6, 7, 10-25, and 27-30 under
35 U.S.C. § I03(a) as obvious over Mallard, 3 Schulz Jr., 4 Avery '600, 5 and
Sawaya6 (Final Act. 3-7).
B. The Examiner rejected claim 45 under 35 U.S.C. § I03(a) as obvious
over Mallard, Schulz Jr., Avery '600, Sawaya, and NYSCC7 (Final Act. 7-
9).
A. 35 USC§ 103(a) over Mallard, Schulz Jr., Avery '600, and Sawaya
The Examiner finds that Mallard teaches "a pharmaceutical
composition for topical application in the form of a gel" that comprises "an
organopolysiloxane elastomer which reads on the claimed siloxane
copolymers ([81] and [92]-[108])" and "solvents which read on the claimed
solvents" (Final Act. 3). The Examiner acknowledges that Mallard does not
teach "antimicrobial agents including 3-(trimethoxysilyl)
propyldimethyloctadecyl ammonium chloride" (id. at 4).
The Examiner finds A very '600 teaches "antimicrobial compositions
comprising 3-( trimethoxysilyl) propyldimethyloctadecyl ammonium
chloride" (Final Act. 4 ). The Examiner finds Sawaya teaches "topical
formulations comprising at least one antibiotic and a triple antibiotic form"
(id.). The Examiner finds Schulz, Jr. teaches "elastomers for thickening
3 Mallard et al., US 2007/0135379 Al, published June 14, 2007.
4 Schulz, Jr. et al., US 5,654,362, issued Aug. 5, 1997.
5 Avery et al., US 2003/0073600 Al, published Apr. 17, 2003.
6 Sawaya et al., US 5,516,808, issued May 14, 1996.
7 NYSCC Showcases Global Technology Under One Roof, 125 COSMETICS
AND TOILETRIES MAGAZINE 12-14 (July 2010).
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Application 14/115,276
silicon oils and solvents including cyclic methyl siloxanes, trimethylsiloxy
end-blocked PDMS, methanol, citronellol, and jasmine" (id.).
The Examiner finds it would have been obvious "to utilize the 3-
( trimethoxysilyl) propyldimethyloctadecyl ammonium chloride of A very
['600], in the formulations of Mallard et al. in order to further enhance the
residual effectiveness of the antimicrobial components of Mallard" (Final
Act. 5). The Examiner finds it would have been obvious "to utilize the triple
antibiotic of Sawaya et al., in the formulations of Mallard et al. in order to
produce a composition with broader antibiotic protection" (id.).
The issue with respect to these rejections is: Does a preponderance of
the evidence of record support the Examiner's conclusion that the prior art
renders claim 1 obvious?
Findings of Fact
1. Mallard teaches "stable, anhydrous pharmaceutical
compositions combining at least one active ingredient and a silicone agent,
said active ingredient being present in a solubilized form in said
composition" (Mallard ,r 1 ).
2. Mallard teaches "organopolysiloxane elastomer[ s ]" (Mallard
,r 82) that may be formulated with "volatile silicone oils" (Mallard ,r,r 90-92)
and be "prepared by crosslinking reaction between polysiloxanes (A)
containing =Si-H groups ... an alpha,omega-diene (B) in the presence of a
catalyst, and a low molecular weight linear or cyclic polysiloxane (C)"
(Mallard ,r 94).
3. Mallard teaches that active ingredients in the composition may
include "antibacterial agents, antibiotics, antiparasitic agents, antifungal
agents" (Mallard ,r 61 ).
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4. Avery '600 teaches "a hard surface antimicrobial cleaner with a
residual antimicrobial effect, and [a] hard surface antimicrobial cleaner that
inhibits the formulation ofbiofilm on the hard surface" (Avery '600 ,r 4).
5. A very '600 teaches that a "hard surface antimicrobial cleaner
according to the invention may optionally include from O to about 5% by
weight of the total weight of the cleaner of an organosilane" and "preferably,
the organosilane is 3-trimethoxysilyl)propyldimethyloctadecyl ammonium
chloride (commercially available as Dow Coming 5772) or 3-
trimethoxysilyl)propylmethyldi( decyl)ammonium chloride. . . . The
organosilane can further enhance the residual effectiveness against bacteria."
(Avery '600 ,r 38).
6. Sawaya teaches in "a 'triple antibiotic' form of the invention,
i.e., including at least Polymyxin B, Neomycin Sulfate and Zinc Bacitracin,
one or more agents are added to stabilize the Zinc Bacitracin" (Sawaya
4:30-33).
7. Schulz, Jr. teaches solvents including "furfural, pine oil,
turpentine, and m-creosol" (Schulz, Jr. 5 :27-28).
Principles of Law
"If a person of ordinary skill can implement a predictable variation,
§ 103 likely bars its patentability." KSR Int'! Co. v. Teleflex Inc., 550 U.S.
398, 417 (2007).
Analysis
We adopt the Examiner's findings of fact and conclusions of law (see
Final Act. 3-7; FF 1-7) and agree that the combination of Mallard, A very
'600, Schulz, Jr., and Sawaya renders the claims obvious.
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We address Appellant's arguments below. 8
Appellant "submits that there would have been no reasonable
expectation of success to reach the claimed invention because there is a
teaching away" (Br. 5). Appellant specifically contends that
Avery teaches away from the use of the silicon-containing
antimicrobial agents in a composition for use on skin. A very is
directed to harsh, sprayable cleaners with residual effectiveness
used in disinfecting hard surfaces, such as glass, tile,
porcelain, fiberglass composites, metallic surfaces, ceramic
surfaces, laminate surfaces, hard polymeric surfaces. See
paragraph [0006] of Avery. Appellant, in stark contrast, sought
to develop a spreadable, thixotropic gel for topical use on a
user's skin.
(Br. 7). Appellant further contends the EPA requires "the label for Dow
Coming 5772 (now Aegis AEM 5772) to state that the product is a 'poison"'
and therefore "it is apparent that a skilled artisan reading the A very patent
would not consider Dow Coming 5772 to be suitable for use in composition
to be used on skin as a hand sanitizer" (Br. 7-8). Appellant concludes
"[b]ecause Avery ['600] teaches away from the use of the missing silicon-
containing antimicrobial agents in a composition useful on skin, one of
ordinary skill in the art would not modify the Mallard reference to
incorporate the missing silicon-containing antimicrobial agents in an effort
to arrive at the claimed invention" (Br. 8).
8 We limit our consideration of the merits of the appealed rejection to the
elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BP AI 1987).
Thus, we read the claims as directed to the use of the elected 3-
(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride as the
antimicrobial agent (see Resp. to Election/Restriction filed on Nov. 12, 2015
at 12).
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Application 14/115,276
We find the argument that A very '600 teaches away unpersuasive for
several reasons. First, we note that the AEM document on which Appellant
relies also specifically states that approved uses include "non-woven
disposable diapers," "wiping cloths," "pre-moistened towelettes and tissue
wipes," and "socks, hosiery, undergarments" (Evidence Appendix, AEM
5772 Antimicrobial at 4). Thus, contrary to Appellant's arguments, the
AEM document reasonably suggests that the compound may safely contact
skin, including the skin of infants, when used in diapers, wiping cloths and
moistened towelettes. Moreover, the AEM document state the antimicrobial
"provides residual self-sanitizing activity against athlete's foot fungus ... on
treated socks" (Evidence Appendix, AEM 5772 Antimicrobial at 4). This
indicates that the compound not only may safely contact skin, but that the
compound retains activity while doing so.
Moreover, we agree with the Examiner that "many chemicals are
considered a poison when stored separately in large amounts, however,
many of said chemicals are suitable for topical formulations in small
quantities" (Ans. 3). Indeed, the AEM document suggests to "[i]ncorporate
AEM 5772 Antimicrobial directly into formulations used to make end-use
products" (Evidence Appendix, AEM 5772 Antimicrobial at 5). Thus, we
agree with the Examiner that the identified dangers of AEM 5772 in the
document refer to the purified and isolated form, not to the compound when
properly incorporated into final products for commercial application.
Second, the Examiner has cited Avery '585, 9 which teaches "aqueous
compositions which can be used as antimicrobial hand cleaner formulations"
9 Avery et al., US 5,411,585, issued May 2, 1995.
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Application 14/115,276
where Example 4 comprises Dow Coming 5772 (Avery '585 17:25-33).
Avery '585 therefore reasonably suggests that the antimicrobial compound
3-(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride in Dow
Coming 5772 may be safely incorporated into compositions for external
application to human skin (see Avery '585 17:25-33).
Third, Appellant does not identify any teaching in A very '600 ( or
indeed in the EPA AEM 5772 Antimicrobial document itself) that criticizes,
discredits, or discourages the use of the antimicrobial compound 3-
(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride in external
use pharmaceutical compositions such as the composition of Mallard (FF 1-
3 ). See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004) ("The prior art's
mere disclosure of more than one alternative does not constitute a teaching
away from any of these alternatives because such disclosure does not
criticize, discredit, or otherwise discourage the solution claimed.").
Therefore, we conclude that neither A very '600, nor the EPA AEM
5772 Antimicrobial document, teach away from the use of 3-
(trimethoxysilyl) propyldimethyloctadecyl ammonium chloride in external
use pharmaceutical compositions.
Appellant contends:
Only after reading the cited references, with the benefit of the
knowledge of Applicant's application, could the Office reach
the conclusion that Applicant's pending claims are obvious in
view of Mallard in view of A very. However, that is not the
standard for obviousness, and the use of hindsight is
impermissible. "The tendency to resort to 'hindsight' based
upon applicant's disclosure is often difficult to avoid due to the
very nature of the examination process.
(Br. 6). Appellant also contends "there is no teaching, suggestion, or
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Application 14/115,276
motivation in the prior art that would have led one of ordinary skill ... to
combine the Mallard reference with the Avery reference" (id.).
We find these arguments unpersuasive. Although we are fully aware
that hindsight bias may plague determinations of obviousness, Graham v.
John Deere Co., 383 U.S. 1, 36 (1966), we are also mindful that the
Supreme Court has clearly stated that the "combination of familiar elements
according to known methods is likely to be obvious when it does no more
than yield predictable results." KSR, 550 U.S. at 416. In the present case,
Mallard teaches a silicone composition as required by claim 1 (FF 1-2) and
specifically teaches inclusion of active agents including "antibacterial
agents, antibiotics, antiparasitic agents, antifungal agents" (FF 3). Avery
'600 teaches that one known agent that "can further enhance the residual
effectiveness [ of a composition] against bacteria" is "3-trimethoxysilyl)
propyldimethyloctadecyl ammonium chloride ( commercially available as
Dow Coming 5772)" (Avery "600 [0038], FF 5).
Therefore, the Examiner reasonably finds that inclusion of A very
'600's agent into Mallard's composition would have been obvious "in order
to further enhance the residual effectiveness of the antimicrobial components
of Mallard" (Final Act. 5). The Examiner provides a specific reason for the
combination, and recognizes as well that the antimicrobial of Avery '600 is a
well-known equivalent anti-microbial compound that was commercially
available (FF 4). 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).
Conclusion of Law
A preponderance of the evidence of record supports the Examiner's
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conclusion that the prior art renders claim 1 obvious.
B. 35 USC§ 103(a) over Mallard, Schulz Jr., Avery '600, Sawaya, and
NYSCC
Appellant does not argue this obviousness rejection. The Examiner
provides sound fact-based reasoning for combining the teachings ofNYSCC
with Mallard, Schulz Jr., Avery '600, and Sawaya (see Final Act. 7-9).
Having affirmed the obviousness rejection of claim 1 over Mallard, Schulz
Jr., Avery '600, and Sawaya for the reasons given above, we also find that
the further combination with NYSCC renders the rejected claim obvious for
the reasons given by the Examiner.
SUMMARY
In summary, we affirm the rejection of claim 1 under 35 U.S.C.
§ 103(a) as obvious over the combination of Mallard, Schulz Jr., Avery
'600, and Sawaya. Pursuant to 37 C.F.R. § 4I.37(c)(l), we also affirm the
rejection of claims 6, 7, 10-25, and 27-30 as these claims were not argued
separately.
We affirm the rejection of claim 45 under 35 U.S.C. § 103(a) as
obvious over the combination of Mallard, Schulz Jr., Avery '600, Sawaya,
andNYSCC.
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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