Ex Parte Roszell

Patent Trial and Appeal Board

Jun 27, 2016

11331410 (P.T.A.B. Jun. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
111331,410 01112/2006 James A. Roszell
23552 7590 06/29/2016
MERCHANT & GOULD P.C.
P.O. BOX 2903
MINNEAPOLIS, MN 55402-0903
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.
13709.19US01 8533
EXAMINER
FRAZIER, BARBARA S
ART UNIT PAPER NUMBER
1611
NOTIFICATION DATE DELIVERY MODE
06/29/2016 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):
USPT023552@merchantgould.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAMES A. ROSZELL 1
Appeal2013-005538
Application 11/331,410
Technology Center 1600
Before DEMETRA J. MILLS, ULRIKE W. JENKS, and TA WEN CHANG,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to skin
disinfectant compositions and methods for using the same, which have been
rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
According to the Specification, "[t]here is a general desire to provide
products that reduce irritation to skin, chapping and redness of skin, and that
provide antimicrobial activity over a relatively long period of time." (Spec.
1 Appellant identifies the Real Party in Interest as Skinvisible
Pharmaceuticals, Inc. (Appeal Br. 2.)
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Application 11/331,410
1 :22-24.) The Specification suggests that this may be accomplished by a
skin disinfectant composition comprising;
an effective amount of a disinfectant active component to
provide disinfectant properties to skin tissue, an effective
amount of a skin bonding polymer component to hold the
disinfectant active component to skin tissue so that the
disinfectant active component becomes available on skin tissue
to provide disinfectant properties, and water.
(Id. at 1 :26-2:3.)
Claims 1, 7, 12, 14--22, 25-35 are on appeal. Claim 1 is illustrative
and reads as follows:
1. A skin disinfectant composition comprising:
(a) about 0.1 wt.% to about 5 wt.% of chlorhexidine
succinate;
(b) an effective amount of a skin bonding polymer
component to hold the disinfectant active component to skin
tissue so that the disinfectant active component becomes
available on skin tissue to provide disinfectant properties,
wherein the skin bonding polymer component comprises a
hydrophobic polymer/hydrophilic polymer adduct wherein the
hydrophobic polymer comprises a poly(vinylpyrrolidone-
alkylene) polymer having an alkylene group containing about
10 carbon atoms to about 30 carbon atoms; and
( c) at least about 50 wt. % water, and wherein the
composition exhibits antiviral activity for at least two hours
after application of the composition to skin tissue.
2
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Application 11/331,410
The claims stand rejected as follows:
Claims 1, 7, 12, 14, 17-22, 28, 32-352 are rejected under 35 U.S.C.
§ 103(a) as being unpatentable over the combination of Roszell, 3 Modak
'846,4 and Modak '532.5
Claims 15 and 16 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over the combination of Roszell, Modak '846, Modak '532,
and Brown.6
Claims 25-27 and 29-31 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over the combination of Roszell, Modak '846, Modak
'532, and Senior.7
DISCUSSION
The Examiner has rejected claims 1, 7, 12, 14, 17-22, 28, 32-35
under 35 U.S.C. § 103(a) as being unpatentable over the combination of
Roszell, Modak '846, and Modak '532. The Examiner finds that Roszell
teaches "topical compositions prepared by diluting a topical composition
2 We note that claim 35 was omitted from the Grounds of Rejection headings
in both the Appeal Brief and the Answer. (Appeal Br. 9; Ans. 5.) However,
both Appellant and the Examiner address claim 3 5 in the context of the
combination of Roszell, Modak '846 and Modak '532. (Appeal Br. 10; Ans.
9.) Thus, we understand that claim 35 is rejected under 35 U.S.C. § 103(a)
as being unpatentable over the combination of Roszell, Modak '846, and
Modak '532.
3 Roszell et al., US 6,756,059 B2, issued June 29, 2004.
4 Modak et al., US 6,846,846 B2, issued Jan. 25, 2005.
5 Modak et al., US 5,705,532, issued Jan. 6, 1998.
6 Brown, US 2005/0271595 Al, published Dec. 8, 2005.
7 Senior, GB 843,676, published Aug. 10, 1960.
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Application 11/331,410
precursor with water and adding additional components," where the
precursor is an adduct of a hydrophobic polymer and a hydrophilic polymer
that meets the limitations of the skin bonding polymer component of
independent claims 1 and 19. (Ans. 5.) The Examiner finds that Roszell's
topical composition comprises "at least one active ingredient, including an
antimicrobial agent, an antifungal agent, and/or an anti-viral agent" and
further is expected to contain at least about 70 wt.% water when provided as
a solution for application to skin tissue. (Id.) The Examiner finds that
Roszell teaches using its compositions as disinfectants. (Id.)
The Examiner finds that Roszell does not specifically teach
chlorhexidine succinate as the active ingredient. (Id. at 6.) However, the
Examiner finds that Modak '846 teaches antimicrobial compositions
comprising octoxyglycerin and at least one other antimicrobial agent and
further discloses chlorhexidine succinate as an example of such
antimicrobial agent. (Id. at 6.) Likewise, the Examiner finds that Modak
'532 teaches antimicrobial compositions that may be incorporated into hand
disinfectants, comprising chlorhexidine or chlorhexidine salts such as
chlorhexidine succinate, a quartemary ammounium compound such as
benzalkonium chloride, and parachlorometaxylenol. (Id.)
The Examiner finds that it would have been obvious to a skilled
artisan to use the active components of Modak '846 or Modak '532 as the
active ingredient of Roszell' s composition and arrive at the claimed
inventions. (Id.) The Examiner finds that a skilled artisan would be able to
select chlorhexidine succinate from the list of antimicrobial agents taught by
Modak '846 or Modak '532 as part of routine experimentation to optimize
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composition efficacy. (Id. 6-7.) In addition, the Examiner finds that
Roszell teaches that components best suited for the composition include
"active ingredients that can be characterized as hydrophobic, neutral polar
such as alcohols, and acidic," and further discloses benzalkonium chloride as
an exemplary active ingredient. (Id. at 5-6.) The Examiner concludes that
based on this description of most suitable compounds a skilled artisan would
be motivated to select such salts as chlorhexidine succinate, a hydrophobic,
acidic compound, from the list of chlorhexidine salts taught by Modak '846
or Modak '532. (Id. at 7.)
The Examiner finds that Roszell and Modak '846 respectively
disclose amounts of antimicrobial agent and chlorhexidine salts that overlap
the ranges claimed. (Id. at 8-9.) Regarding the functional limitation relating
to antiviral activity, the Examiner finds that the prior art composition would
inherently possess such properties given the fact that the active ingredient of
the prior art composition is the same as that of the claimed invention. (Id.)
We agree with and adopt the Examiner's fact-finding, reasoning, and
conclusion with respect to claims 1, 19, and 33-35. (Id. at 5-11, 15-19.)
Claims 7, 12, 14, 17-22, and 32 have not been argued separately and
therefore fall with claims 1, 19, and 33-35. 37 C.F.R. § 41.37(c)(l)(iv).
Below we address Appellant's arguments.
Appellant contends that Roszell fails to disclose chlorhexidine
succinate and the antiviral activities recited in claims 1, 19, and 33-35.
(Appeal Br. 10.) Appellant further contends that Modak '846 and Modak
'532 "would not have suggested modifying [Roszell] by adding
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Application 11/331,410
chlorhexidine succinate in order to achieve antiviral properties according to
[]Appellant's invention." (Id.)
Appellant first argues that Modak '846 and Modak '532 disclose
chlorhexidine succinate only as part of a lengthy list of antimicrobial agents
and/ or chlorhexidine salts and provide no teaching or suggestion to
specifically select chlorhexidine succinate for use in Roszell's composition.
(Id. at 10, 12-13.) Appellant also argues that Modak '846 and Modak '532
did not recognize the advantage of chlorhexidine succinate over other
chlorhexidine salts, i.e., that at the desired pH of use the combination of
chlorhexidine and succinic acid favors formation of a salt that is relatively
insoluble, which allows it to be held by the skin bonding polymer
component of the claimed invention. (Id. at 11, 13.)
These arguments are not persuasive. As the Examiner points out,
Roszell teaches that components best suited for its composition include
"active ingredients that can be characterized as hydrophobic, neutral polar
such as alcohols, and acidic." (Ans. 15.) Based on this teaching, a skilled
artisan would select an active ingredient for Roszell's composition that is
relatively water insoluble, such as chlorohexidine succinate. The fact that
Modak '846 and Modak '532 may disclose hydrophobic antimicrobials other
than chlorohexidine succinate does not render the claim non-obvious. See
Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 ("That the
[prior art] discloses a multitude of effective combinations does not render
any particular formulation less obvious.").
Appellant next argues that Modak '846 teaches the use of
antimicrobial agents such as chlorohexidine with octoxyglycerin and,
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preferably, a quaternary ammonium compound. (Appeal Br. 12.) Appellant
argues that there is no reason for a skilled artisan to use a combination of
relatively water insoluble chlorhexidine salt and water soluble
octoxyglycerin in Roszell's composition. (Id.)
We are not convinced. As the Examiner points out, Roszell teaches
that its composition may be used with presently available topical
compositions (Ans. 8), and the combination of chlorhexidine salt and
octoxyglycerin offers the advantage of an antimicrobial formulation more
effective than prior compositions without increased skin irritation (id. at 7).
Thus, the Examiner has made a prima facie case that a skilled artisan would
find it obvious to combine the teachings of Roszell and Modak '846. In
contrast, Appellant has offered no more than attorney argument that a skilled
artisan would not include octoxyglycerin in Roszell' s composition because
of its relative water solubility. In any event, as the Examiner also points out,
Modak '846 discloses that octoxyglycerin is hydrophobic. (Ans. 16.)
Similarly, we note but are not persuaded by Appellant's arguments
that Modak '532 contemplates a different type of composition than that
disclosed in the application or in Roszell because Modak '532 suggests that
its composition may contain alcohol. (Appeal Br. at 13.) While Appellant
contends that one of the advantages of the claimed composition is that it
does not need to include alcohol (id.), this alleged advantage is not recited in
the claims. (Ans. 17 .)
We are likewise unconvinced by Appellant's apparent argument that
the claims are non-obvious because Modak '532 does not disclose the
claimed invention's advantage of "prolonged disinfectant properties over
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Application 11/331,410
time." (Appeal Br. 13-14.) "Non-obviousness cannot be established by
attacking references individually where the rejection is based upon the
teachings of a combination of references. . . . [The reference] must be read,
not in isolation, but for what it fairly teaches in combination with the prior
art as a whole." In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
In this case, Roszell discloses that its composition is expected to bind to skin
tissue for at least four hours and to hold active ingredients in proximity to
skin for that length of time to allow for delivery of the ingredients. (Roszell
4:27-34; Ans. 17 .)
Appellant further argues that the cited prior art do not render the
claims obvious because Modak '532 is directed towards an antimicrobial
scrub without a skin bonding polymer component, because a skilled artisan
would not expect a scrub composition to include such a component, and
because there is no reason to combine Modak '532 and Roszell given that
Roszell is not a scrub. (Appeal Br. 14--15.)
None of these arguments are convincing. As already discussed,
Appellant cannot establish non-obviousness by attacking the disclosure of
Modak '532 individually since the rejection is based on the combination of
Roszell, Modak '846 and Modak '532. In re Merck, 800 F.2d at 1097. To
the extent Appellant is arguing that a skilled artisan would not find it
obvious to combine Roszell and Modak '532 because Roszell is not a scrub,
we are not convinced. Modak '532 is not limited to scrubs simply because it
exemplifies them: A reference is relevant for all that it teaches, In re Fritch,
972 F.2d 1260, 1264 (Fed. Cir. 1992), and Modak '532 discloses that its
compositions may be used without limitation as "hand disinfectants, hand
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Application 11/331,410
soaps, topical creams, antiseptic rinses or soaks, and antiseptic towelettes."
(Modak '532 3:57-60; Ans. 17-18.) Furthermore, even assuming that
Modak '532 is limited to scrubs and Roszell does not disclose a scrub,
Appellant has not provided sufficient persuasive evidence that it would not
be obvious to a skilled artisan to combine the disclosures of Roszell and
Modak '532. The portion of Modak '532 cited by Appellant states that
compositions that rapidly and effectively provides anti-microbial activity is
desirable; such a statement does not suggest that a skilled artisan would not
have reason to incorporate extended disinfectant property in the
composition. (Modak '532 2:8-12.) "A person of ordinary skill is also a
person of ordinary creativity, not an automaton." KSR Int'! Co. v. Teleflex
Inc., 550 U.S. 398, 421 (2007).
Appellant next contends that the claims are non-obvious because none
of the cited prior art recognized or suggested the antiviral activity recited in
the claims and because such activities were unexpected. 8 (Appeal Br. 10-
11, 16, 17-24.) We are not convinced. "[T]he discovery that a claimed
composition possesses a property not disclosed for the prior art subject
matter, does not by itself defeat a prima facie case." In re Dillon, 919 F .2d
688, 693 (Fed. Cir. 1990). Here, the prior art would have made obvious a
8 Claims 1 and 19 recite that the claimed composition "exhibits antiviral
activity for at least two hours after application of the composition to skin
tissue." Claims 33-34 depend from claim 1 and further recite that the
antiviral activity is against, respectively, H5Nl Avian Flu virus and
Influenze NIBRG-14 virus. Claim 3 5 also depends from claim 1 and further
recite that the composition exhibits a 2 log reduction in H5Nl Avian Flu
virus.
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Application 11/331,410
composition comprising the claimed weight percentage of the active
ingredient chlorhexidine succinate, the claimed skin bonding polymer, and
the claimed weight percentage of water. Based on the evidence of record, it
is reasonable to shift the burden of proof to Appellant to show that the
functional limitations regarding antiviral activity is not inherent in the
composition made obvious by prior art. In re Best, 562 F.2d 1252, 1254--55,
(CCPA 1977) (quoting In re Swinehart, 439 F.2d 210, 212-13 (CCPA
1971 )) ("' [M]ere recitation of a newly discovered function or property,
inherently possessed by things in the prior art, does not cause a claim ... to
distinguish over the prior art. Additionally, where the Patent Office has
reason to believe that a functional limitation asserted to be critical for
establishing novelty in the claimed subject matter may, in fact, be an
inherent characteristic of the prior art, it possesses the authority to require
the applicant to prove that the subject matter shown to be in the prior art
does not possess the characteristic relied on.'").
Appellant argues that inherency cannot be based on a combination of
references to support an obviousness rejection. (Id. at 20; Reply Br. 3--4.)
We disagree. Our reviewing court has recognized that "inherency may
supply a missing claim limitation in an obviousness analysis" where, as here,
the limitation is the "natural result" of the combination of prior art elements.
PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186, 1194--1195 (Fed. Cir.
2014).
Appellant's citation to In re Soni is also inapposite. In re Soni does
not stand for the proposition that inherency cannot be based on a
combination of references to support an obviousness rejection; it merely
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Application 11/331,410
holds that, under some circumstances, a showing of unexpected results may
rebut a prima facie case of obviousness. In re Soni, 54 F.3d 746, 750 (Fed.
Cir. 1995). Appellant has not made any such showing. Although Appellant
contends in the Appeal Brief that the antiviral properties of the claimed
compositions are surprising and unexpected, "[a]ttomey's argument in a
brief cannot take the place of evidence." In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974). In this case, Examples 1and2 of the Specification, the
only factual evidence cited in support of Appellant's expected results
argument, show that one claimed composition has antiviral activity. In
contrast to Soni, however, nothing in the Specification suggests that this
result was unexpected, much less that it was unexpected compared to the
closest prior art. In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir.
1991) (explaining that unexpected results must be shown to be unexpected
compared with the closest prior art). Neither is the alleged evidence of
unexpected results, which provides data only for a single composition,
commensurate with the claim scope. In re Dill, 604 F.2d 1356, 1361 (CCPA
1979) ("The evidence presented to rebut a prima facie case of obviousness
must be commensurate in scope with the claims to which it pertains.").
Finally, Appellant argues in the Reply Brief that "[t]he Examiner's
Answer fails to provide any support for the contention that the antiviral
property is inherent in chlorhexidine succinate by itself' and "fails to
provide any support that the alleged inherency was known prior to the
priority date of the above-identified patent application." (Reply Br. 2.)
Appellant thus argues that "the Examiner has taken 'official notice' without
actually stating that she has taken 'official notice."' We disagree. The
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Examiner is reasonably contending based on Roszell' s disclosure and the
Specification that the alleged antiviral activity is due to the active agent
chlorhexidine succinate while the composition comprising the skin bonding
polymer serves the purpose of making the active agent available to skin
tissue for an extended period of time. (Ans. 18-19.)
Based on the same arguments set forth for claims 1, 19, and 33-35,
Appellant also requests the reversal of the 35 U.S.C. § 103 rejections of
claims 15 and 16 as obvious over Roszell, Modak '846, Modak '532 and
Brown and claims 25-27 and 29-31 as obvious over Roszell, Modak '846,
Modak '532, and Senior. These arguments are not persuasive for the
reasons already discussed. Thus, we also affirm the rejections of claims 15,
16, 25-27 and 29-31.
SUMMARY
We affirm the rejection of claims 1, 7, 12, 14, 17-22, 28, 32-35,
under 35 U.S.C. § 103(a) as obvious over Roszell, Modak '846, and Modak
'532. We also affirm the rejections of claims 15 and 16 under 35 U.S.C.
§ 103(a) as obvious over Roszell, Modak '846, Modak '532, and Brown and
the rejections of claims 25-27 and 29-31 under 35 U.S.C. § 103(a) as
obvious Roszell, Modak '846, Modak '532, and Senior.
TIME PERIOD FOR RESPONSE
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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