Angeliqueo E. Padilla et al.

Patent Trials and Appeals Board

Jun 2, 2020

14082662 - (R) (P.T.A.B. Jun. 2, 2020)

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.
14/082,662 11/18/2013 Angeliqueo E. Padilla P05542US 3303
23702 7590 06/02/2020
Bausch & Lomb Incorporated
1400 North Goodman Street
Rochester, NY 14609
EXAMINER
FAY, ZOHREH A
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
06/02/2020 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):
patents@bausch.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ANGELIQUEO E. PADILLA and GEORGE A. BAKLAYAN
____________

Appeal 2019-000150
Application 14/082,662
Technology Center 1600
____________

Before ULRIKE W. JENKS, ELIZABETH A. LAVIER, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellant1 requests rehearing of the Decision entered March 13, 2020.
Appellant raises several points “believed to have been misapprehended or
overlooked by the Board.” Req. Reh’g 1. As explained below, Appellant
has not persuasively shown that the Board overlooked or misapprehended
the matters alleged. Accordingly, we do not modify the Decision.
Appellant contends that the Decision “misapprehends or overlooks the
fact” that there is no teaching “of any actual storage stable solution
specifically including each of polyquaternium-1, bromfenac, water, and non-
ionic surfactants such as poloxamers and polyethoxylated castor oil in

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies Beiersdorf AG as the real party in
interest. Appeal Br. 3.
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Desai.” Id. at 1. This argument is not persuasive. As explained in the
Decision, “Desai teaches aqueous pharmaceutical compositions comprising
all of the ingredients recited in [Appellant’s] claim 1.” Decision 5 (citing
FF1–FF2). The fact that Desai also teaches formulations comprising other
acidic drugs, both with and without the recited non-ionic surfactants, “does
not render any particular formulation any less obvious.” Merck & Co., Inc.
v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
Appellant urges that “Desai only discloses bromfenac as a possible
active agent, and the noted surfactants as optional components that each
might or might not be used.” Req. Reh’g 2. We disagree. Desai teaches
“‘storage-stable preserved ophthalmic compositions containing acidic drugs
in combination with polymeric quaternary ammonium compounds’ such as
polyquaternium-1.” Decision 3 (quoting Desai, Abstr., 2:49–50). Indeed,
Desai specifically identifies bromfenac as one of approximately 10 such
acidic drugs and teaches that all of them are “suitable” for stabilization by
formulation with polyquaternium-1. Desai, 3:7-18. Desai further teaches
that certain of the recited non-ionic surfactants (e.g., poloxamers and
polyethyoxylated castor oil) “may additionally” be included in these
formulations. Id. Thus, we agree with Examiner that Desai, in fact, teaches
compositions comprising all of the ingredients recited in claim 1.
Appellant argues that our reliance on In re Dillion, 919 F.2d 688 (Fed.
Cir. 1990) is misplaced because “Examiner has not provided any reason or
motivation to make any selection of specific surfactants from the mere
possibilities of various optional components disclosed in Desai and Sawa.”
Req. Reh’g 2. Again, we are not persuaded because Desai teaches
formulations comprising all of the claimed ingredients. Moreover, Sawa
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additionally teaches bromfenac in combination with various of the non-ionic
surfactants recited in Appellant’s claims. Decision 4 (FF4). We agree with
Examiner that it would have been obvious to use such surfactants in Desai’s
compositions because Sawa teaches that their “‘combination with bromfenac
is considered to be old and well known.’” Id. at 5 (quoting Final 4); see KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (“The combination of
familiar elements according to known methods is likely to be obvious when
it does no more than yield predictable results.”). Thus, the record is
sufficient to establish a prima facie case of unpatentability based on the
structural similarity between the prior art and Appellant’s claims. Id. at 6.
Appellant further argues that the Decision overlooked or
misapprehended various points related to its unexpected results evidence.
See Req. Reh’g 3–5. First, Appellant contends that it was not required to
demonstrate unexpected results as compared to the formulations taught in
Desai because “there is no actual composition disclosed in Desai which
comprises all of the ingredients of claim 1, and in particular no actual
composition comprising bromefenac [sic].” Id. at 3. As explained above,
we disagree with the premise of Appellant’s argument because Desai teaches
compositions comprising all of the ingredients of claim 1. Thus, contrary to
Appellant’s assertion, the Decision does not suggest that Appellant must
demonstrate unexpected results as compared to a “non-existing, theoretical
composition.” Id. at 3. Rather, we agreed with Examiner (see Ans. 8) that
Appellant had not demonstrated unexpected results as compared to those
formulations in Desai comprising bromfenac, polyquaternium-1, water, and
a non-ionic surfactant such as a poloxamer. Decision 7.
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Appellant next asserts that the Board’s determination that Appellant
had “not shown that the difference in the percentage of bromfenac remaining
after one month is a difference in ‘kind and not merely in degree’ . . . should
be designated as a new grounds of rejection first stated in the Decision.”
Req. Reh’g 4, 6. We are not persuaded. As our reviewing court has
explained:
When considering whether the PTAB issued a new ground of
rejection, the ultimate criterion of whether a rejection is
considered new in a decision by the PTAB is whether
applicants have had fair opportunity to react to the thrust of the
rejection. The PTAB is not limited to reciting and agreeing
with the examiner’s rejection in haec verba; indeed, it may
further explain the examiner’s rejection and thoroughly respond
to an applicant’s argument.
Knowles Electronics LLC v. Iancu, 886 F.3d 1369, 1376–77 (Fed. Cir. 2018)
(internal quotations omitted).
Appellant, here, had a fair opportunity to respond to the rejection and
present unexpected results evidence to attempt to overcome Examiner’s
prima facie showing. Moreover, it was Appellant’s burden to establish that
any such results “are unexpected and significant.” MPEP § 716.02(b)(I).
Appellant, however, did not present “sufficient evidence to show that the
differences observed in the data here would have been beyond the capability
of a skilled artisan such that they are more than mere differences in degree.”
Decision 8. That observation is not a new ground of rejection, but simply a
more thorough explanation of Examiner’s determination that Appellant’s
unexpected results evidence was unpersuasive.
Appellant additionally contends that “a ‘difference in degree’ of 7%”
is “a difference in kind as it represents losing 100% more bromfenac (i.e.,
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losing twice the amount of bromfenac).” Reh’g Req. 4. That argument, like
those in Appellant’s prior briefing, is “unsupported attorney argument” and
not persuasive. See Decision 8 (citing In re De Blauwe, 736 F.2d 699, 705
(Fed. Cir. 1984)).
Finally, Appellant urges that the Board “misapprehends or overlooks
that the claims have been limited to specific combinations of preservatives
and surfactants, where each specific claimed combination has been shown to
enable the specific claimed high level of bromfenac stability, while other
possible combinations . . . have been shown to result in significantly lower
levels of stability than that required for the present claimed invention.”
Reh’g Req. 5. This argument is not persuasive for the reasons noted in the
Decision. See Decision 7–9 (identifying “shortcomings” in Appellant’s
unexpected results evidence and determining such “evidence is insufficient
to overcome the strong prima facie showing”).
In conclusion, Appellant has not identified an issue of fact or law that
was overlooked or misunderstood. Therefore, the Request is denied.
Outcome of Decision on Rehearing:
Claims 35 U.S.C. § Reference(s)/Basis Denied Granted
1, 3, 6–9,
13, 15, 18,
21–23
103 Desai, Sawa 1, 3, 6–9,
13, 15, 18,
21–23

Final Outcome of Appeal after Rehearing:
Claims 35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 3, 6–9,
13, 15, 18,
21–23
103 Desai, Sawa 1, 3, 6–9,
13, 15,
18, 21–23

REHEARING DENIED