David G. Davies

Patent Trials and Appeals Board

Dec 26, 2019

13945207 - (D) (P.T.A.B. Dec. 26, 2019)

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.
13/945,207 07/18/2013 David G. DAVIES SUNY 265.2-P/5739-290 4263
90150 7590 12/26/2019
Tully Rinckey PLLC
777 Third Avenue
New York, NY 10017
EXAMINER
PARAD, DENNIS J
ART UNIT PAPER NUMBER
1612
NOTIFICATION DATE DELIVERY MODE
12/26/2019 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):
shoffberg@tullylegal.com
steve@hoffberglaw.com
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DAVID G. DAVIES1
Appeal 2018-003106
Application 13/945,207
Technology Center 1600
Before ERIC B. GRIMES, RACHEL H. TOWNSEND, and
CYNTHIA M. HARDMAN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to oral
care compositions, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
“[N]atural and artificial chemical agents are unable to adequately
attack and destroy infectious biofilm populations.” Spec. ¶ 4. “The present

1 Appellant identifies the real party in interest as the Research Foundation
for the State University of New York. Appeal Br. 1. We use the word
Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a).
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Application 13/945,207

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invention addresses the ‘biofilm problem’ by artificially inducing bacteria to
undergo physiological process of biofilm dispersion.” Id. ¶ 28. “The
examples of situations in which artificial dispersion would be of benefit
include improved cleaning of . . . teeth.” Id. The Specification discloses that
dispersion inducers include cis-2-decenoic acid. Id. ¶¶ 88–90.
Claims 21, 22, 24, and 26–28 are on appeal. Claim 21, reproduced
below, is illustrative:
21. A dentifrice composition comprising:
cis-2-decenoic acid, wherein the concentration of cis-2-
decenoic acid in the composition is 0.001 μM to 30 μM,
said dentifrice composition being selected from the group
consisting of breath spray, tooth powder, whitening strips,
prophylaxis strips, breath strips, lozenges, and breath mints.

All of the other claims on appeal also are directed to a type of oral
care (dentifrice, mouthwash, or toothpaste) composition comprising 0.001
μM to 30 μM cis-2-decenoic acid.
The claims stand rejected as follows:
Claims 21, 22, 24, and 28 under 35 U.S.C. § 103(a) as obvious based
on Thiele2 as evidenced by McDonnell3 (Ans. 2) and
Claims 26 and 27 under 35 U.S.C. § 103(a) as obvious based on
Thiele and Burzynski4 (Ans. 4).

2 US 4,442,125, iss. Apr. 10, 1984.
3 Gerald McDonnell et al., Antiseptics and Disinfectants: Activity, Action,
and Resistance, Clinical Microbiology Reviews 12(1): 147−179 (1999).
4 US 2004/0241107 A1, pub. Dec. 2, 2004.
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OPINION
All of the claims on appeal stand rejected under 35 U.S.C. § 103(a) as
obvious based on Thiele, by itself (as evidenced by McDonnell), or
combined with Burzynski. The same issue is dispositive for both rejections.
The Examiner finds that “Thiel[e] teaches a composition for
preventing microorganisms . . . from attaching to a surface by causing a
dispersion of the microorganisms in the body fluids.” Ans. 2. The
composition can be a dentifrice. Id. at 3. The Examiner finds that Thiele’s
composition comprises a fatty acid having one double bond (i.e.,
monoethenoid), “includ[ing], inter alia, 2-decenoic acid (col 6, line 41) and
wherein a preferred isomeric form of the monoethenoid fatty acid is cis
(‘trans isomers . . . do not give anywhere as good results’).” Id.
The Examiner finds that “Thiel[e] further teaches that the fatty acid
ranges from 0.5 to about 10 percent by weight of the composition (col 10,
lines 1–4) and can be modulated based on the threshold or dose-related
effect.” Id. The Examiner cites McDonnell as evidence that the ethanol in
Thiele’s composition is an antimicrobial agent. Id.
The Examiner concludes that it would have been obvious to
select[] cis-2-decenoic acid as a monoethenoid fatty acid and
optimiz[e] the concentration to 0.001 μM to 30 μM because
Thiel[e] teaches that the concentration of the fatty acid
component is a result-effective variable for determining
optimum or workable ranges by routine experimentation based
on the threshold or dose-related effect of the specific
microorganism.
Id. at 4.
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Appellant argues, among other things, that the Davies Declaration5
presents evidence that “[t]he claimed concentrations of cis-2-decenoic acid
are 0.001 μM to 30 μM, are between 3 and 7 orders of magnitude less than
the concentrations of Thiele.” Appeal Br. 20–21. Appellant argues that “[a]
person of ordinary skill would not, based on Thiele, have expected that any
fatty acid, let alone cis-2-decenoic acid, would have had a significant effect
on bacteria at a concentration below 30 μM, three orders of magnitude
below the minimum concentration suggested by Thiele as being effective.”
Id. at 21.
We agree with Appellant that the Examiner has not shown that it
would have been obvious to formulate Thiele’s composition to comprise
0.001–30 µM cis-2-decenoic acid with a reasonable expectation of success.
Thiele discloses “a process for preventing and/or retarding microbes from
attaching or reattaching to surfaces.” Thiele 3:5–7. Thiele’s process uses a
composition comprising a fatty acid salt “prepared from an unsaturated fatty
acid having one double bond and from an alkali metal, alkaline earth metal,”
etc. Id. at 3:23–25. Thiele discloses that one suitable fatty acid is 2-decenoic
acid. Id. at 6:41. (Appellant disputes whether a skilled artisan would have
considered 2-decenoic acid, or the cis isomer thereof, to be obvious choices
based on Thiele’s disclosure, but for the reasons discussed below, we find it
unnecessary to address those issues.)
Thiele states that “[t]he liquefied composition should contain between
about 0.5 to 1 and about 10 percent by weight of the fatty acid salt and
usually contains between 4 and 6 percent by weight of the fatty acid salt.”

5 Declaration under 37 C.F.R. § 1.132 of David G. Davies, filed June 21,
2016.
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Id. at 10:1–4. Thus, Thiele suggests using a minimum of 0.5% by weight of
a fatty acid salt (e.g., a salt of 2-decenoic acid) in its composition, while the
claims on appeal are limited to a maximum of 30 µM cis-2-decenoic acid.
The Davies Declaration states that the “0.5 to 10 percent by weight of
a fatty acid salt . . . concentrations of Thiele correspond to” between
29,388.6 and 587,371.6 µM for cis-2-decenoic acid. Davies Decl. ¶ 15. Dr.
Davies states that “[t]he claimed concentrations of cis-2-decenoic acid are
. . . between 3 and 7 orders of magnitude less than the concentrations of
Thiele.” Id.
In response, the Examiner states that
it is unclear how Appellant determined the specific micromolar
concentrations of cis-2-decenoic acid of Thiel[e] based on the
exemplary fatty acid weight percentages of Thiel[e] without
considering the molecular weight of the other remaining
components of the composition (e.g., thickeners and other
excipients; see, e.g., col 11, lines 1–35) and the final density of
the composition.
Ans. 14. The Examiner concludes that “the data proved in Table 1 in the
Davies Declaration and the data in Appellant’s arguments is based on
assumptions and unsubstantiated facts that are improper for rebutting the
prima facie case of obviousness.” Id. at 15.
However, the Examiner has not pointed to evidence or provided
persuasive technical reasoning showing that the sources of potential error he
points to in Appellant’s calculation would result in the converted values
being three orders of magnitude—a thousand times—higher than they
should be. Nor has the Examiner provided an alternative calculation showing
that Thiele’s 0.5% by weight minimum is close to the claims’ 30 µM
maximum.
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In essence, the Examiner reasons that, because Thiele discloses that a
range of fatty acid salt concentrations can be used, a skilled artisan would
recognize that fatty acid salt concentration is a result-effective variable; thus,
it would have been obvious to use any concentration, no matter how
different from Thiele’s expressly described range, as a matter of routine
optimization. See Ans. 15–16. This position is not consistent with the
Examiner’s burden of showing prima facie obviousness.
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness.” In re
Rijckaert, 9 F.3d 1531, 1532 (Fed. Cir. 1993). “[A] proper analysis under
§ 103 requires, inter alia, consideration of . . . [whether] those of ordinary
skill would have had a reasonable expectation of success.” In re Vaeck, 947
F.2d 488, 493 (Fed. Cir. 1991). “[T]he reasonable expectation of success
must be founded in the prior art, not in the applicant’s disclosure.” Id.
A desire to optimize result-effective variables does not negate the
requirement for a reasonable expectation of success. It is true that, “where
the general conditions of a claim are disclosed in the prior art, it is not
inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955) (emphasis
added). The “general conditions of a claim,” however, include the values of
the parameters recited in a claim. See In re Applied Materials, 692 F.3d
1289, 1295 (Fed. Cir. 2012) (“In the present case, because the prior art
disclosed values overlapping the claimed ranges, the ‘general conditions’ of
the claim are disclosed.”).
The court has stated that a prima facie case of obviousness can exist
even when the claimed and prior art values do not overlap, but even then
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they must be “close enough such that one skilled in the art would have
expected them to have the same properties.” In re Peterson, 315 F.3d 1325,
1329 (Fed. Cir. 2003). Thus, the burden remains on the Examiner to show
that the prior art would have suggested the claimed conditions to a skilled
artisan.
Where, as here, the Examiner has not presented a basis for concluding
that the amounts recited in the reference are comparable to the amounts
required by the claims, and Appellant has presented calculations showing
that the claimed and prior art amounts differ by at least a thousand-fold,
“routine optimization” alone cannot be relied on to show that the claimed
amount of cis-2-decenoic acid would have been obvious to a skilled artisan.
We conclude that the Examiner has not shown that a skilled artisan would
have had a reasonable expectation of success in modifying Thiele’s
composition to comprise 0.001–30 µM cis-2-decenoic acid, as claimed.
The Examiner has not pointed to any disclosure in McDonnell or
Burzynski that remedies the deficiency in Thiele. We therefore reverse the
rejection of claims 21, 22, 24, and 28 under 35 U.S.C. § 103(a) based on
Thiele as evidenced by McDonnell, and the rejection of claims 26 and 27
under 35 U.S.C. § 103(a) as obvious based on Thiele and Burzynski.

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DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
21, 22, 24,
28
103(a) Thiele, McDonnell 21, 22, 24,
28
26, 27 103(a) Thiele, Burzynski 26, 27
Overall
Outcome
21, 22, 24,
26–28

REVERSED