Ex Parte Likitlersuang et al

Patent Trial and Appeal Board

Jun 20, 2018

13812599 (P.T.A.B. Jun. 20, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/812,599 05/22/2013
51957 7590 06/22/2018
ALLERGAN, INC.
2525 DUPONT DRIVE, T2-7H
IRVINE, CA 92612-1599
FIRST NAMED INVENTOR
Sukhon Likitlersuang
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.
18606US (AP) 1930
EXAMINER
FAY,ZOHREHA
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
06/22/2018 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_ip@allergan.com
pair_allergan@firsttofile.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SUKHON LIKITLERSUANG, AJAY P ARASHAR,
CHETANP. PUJARA,
and WILLIAM F. KELLY
Appeal2017-006202
Application 13/812,599 1
Technology Center 1600
Before FRANCISCO C. PRATS, JEFFREY N. FRED MAN, and
RICHARD J. SMITH, Administrative Patent Judges.
PRATS, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134(a) involves claims to a
preservative free composition for lowering intraocular pressure. The
Examiner rejected the claims for obviousness.
We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner's rejection of
1 Appellants identify Allergan, Inc. as the real party in interest. Appeal Br.
3.
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Application 13/812,599
claims 1-11 under 35 U.S.C. § I03(a) for obviousness over Chang2 and
Schiffman. 3 Ans. 2--4. 4
Claim 1 below is illustrative and reads as follows (Appeal Br. 15):
1) A preservative free brimonidine and timolol composition
for lowering intraocular pressure in a human patient
comprising the following formulation:
about 0.2% w/v brimonidine tartrate; about 0.5% w/v
timolol; about 2.15% w/v sodium phosphate dibasic
heptahydrate; water and at a pH of about 6.9.
DISCUSSION
The Examiner's Prima Facie Case
The Examiner found that Chang describes a composition for lowering
intraocular pressure in a human patient, the disclosure of Chang differing
from the invention recited in Appellants' claims 1-11 only in that Chang
does not "specifically point[] out that the composition is free of
preservatives." Ans. 3. The Examiner noted, however, that "claims 1-3 and
13-15 of Chang et al. do[] not contain any preservatives." Id.
As additional evidence that it would have been obvious to prepare a
preservative free version of Chang's composition, the Examiner cited
Schiffman as teaching that "an ophthalmic acceptable liquid composition
can be packaged for single use with no preservative to prevent
contamination over multiple use." Id. (citing Schiffman 3:16-18).
2 US 2003/0199507 Al (published Oct. 23, 2003).
3 WO 2008/024846 A2 (published Feb. 28, 2008).
4 While the Claims Appendix indicates that claim 10 has been withdrawn
from consideration (Appeal Br. 16), the Examiner includes claim 10 among
the claims subject to the appealed rejection (Ans. 3).
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Based on the references' combined teachings, the Examiner reasoned
that it would have been obvious to "exclude the preservatives in the
composition of Chang et al., motivated by the teachings of WO patent,
which teaches the combination of brimonidine and timolol in an ophthalmic
formulation can be used without a preservative." Id. at 3--4.
Furthermore, the Examiner reasoned, although "Chang does not
specifically discuss the lack of a preservative, []claims 1-3 and 13-15 of
Chang et al. do not specifically teach the presence of any preservative." Id.
at 4. Therefore, the Examiner reasoned, the cited references "make clear
that ... the combination of brimonidine and timolol can be used without the
addition of a preservative." Id.
Analysis
As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992):
[T]he [E]xaminer bears the initial burden ... of presenting a
primafacie case ofunpatentability ....
After evidence or argument is submitted by the applicant in
response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In the present case, having carefully considered the arguments and
evidence advanced by Appellants and the Examiner, Appellants persuade us
that the preponderance of the evidence does not support the Examiner's
conclusion of obviousness. In particular, as discussed below, although we
agree with the Examiner that Chang and Schiffman would have suggested
the claimed compositions and methods, Appellants persuade us that they
have presented evidence of unexpected results sufficient to outweigh the
Examiner's evidence of prima facie obviousness.
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As to the Examiner's prima facie case, it is undisputed that Chang
describes a composition differing from the claimed composition only in that
Chang does not disclose that its composition is free of preservatives. See,
e.g., Chang ,r 19 (Composition disclosed in Table includes all ingredients
recited in claim 1 at claimed concentrations, but also includes benzalkonium
chloride.).
Upon careful reading of Chang, however, it is evident that a
preservative need only be included in its compositions when the
compositions are intended for multiple uses: "Ophthalmic products are
typically packaged in multidose form. Preservatives are thus required to
prevent microbial contamination during use." Id. ,r 11 (emphasis added).
Schiffman, like Chang, discloses compositions containing
brimonidine and timolol and the use of those compositions for treating
ocular hypertension. Schiffman 2-3.
Consistent with Chang, Schiffman teaches that preservatives are not
required when ophthalmic compositions are prepared for a single use: "[ A ]n
ophthalmically acceptable liquid should either be packaged for single use,
or contain a preservative to prevent contamination over multiple uses." Id.
at 3 (emphasis).
Thus, viewing the references' combined teachings as a whole, we
agree with the Examiner that, when preparing Chang's composition as a
single use formulation, an ordinary artisan would have considered it obvious
to omit the preservative. Moreover, because Chang and Schiffman teach
that single use formulations need not contain a preservative, the fact that the
examples of Chang and Schiffman all include the preservative benzalkonium
chloride does not persuade us that the references teach away from omitting
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preservatives from single use formulations, when the references' teachings
are viewed as a whole. See also In re Mills, 470 F.2d 649, 651 (CCPA
1972) ("All the disclosures in a reference must be evaluated, including
nonpreferred embodiments,[] and a reference is not limited to the disclosure
of specific working examples.") (citations omitted); 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.").
In sum, given the teachings in both Chang and Schiffman suggesting
the omission of preservatives from single use compositions, Appellants do
not persuade us that the Examiner's prima facie case lack sufficient
evidentiary support. As to the issue of unexpected results, however, we find
that Appellants have the better position.
Appellants submit the Shen Declaration, 5 as evidence of unexpected
results. See Appeal Br. 11-13; Reply Br. 4--5. In the Shen Declaration, the
declarant describes the results of a comparison in which the claimed
preservative free composition ("Combigan® PF"), and the composition
described in Chang ("Combigan®"), were administered to test animals
(beagle dogs), and the reduction in intraocular pressure ("IOP") was
measured. See Shen Deel. ,r,r 3-6.
The declarant states that, as compared to the composition of Chang,
the claimed preservative free composition was superior overall in reducing
5 Declaration under 37 C.F.R. § 1.132 of Dr. Jie Shen (signed Feb. 5, 2015).
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IOP, and in particular reduced IOP to a statistically significantly greater
degree at 2 hours and 8 hours, a result that was unexpected:
The differences in IOP were statistically significant at the 2 and
8 hour time points (p<0.001, p=0.039, respectively). When
compared to preserved Combigan®, the consistent reduction in
IOP shown by Combigan® PF over the entire time period,
together with the unexpectedly greater reduction in IOP at the
aforementioned time points was surprising and unexpected.
Shen Deel. ,r 6; see also id. ,r 9 ("[T]he results of this study, which showed
an increased I OP-lowering effect for Combigan® PF at several time points,
together with comparable efficacy to that of preserved Combigan®, is a
surprising and unexpected finding that can benefit patients with glaucoma
and ocular hypertension.").
The declarant also states that the superiority of the preservative free
composition of the claims was surprising because omission ofbenzalkonium
chloride would have been expected to reduce efficacy (id. ,r 7), and that the
improved IOP reduction eight hours after administration was anticipated to
be particularly significant in light of a known issue where IOP increased in
patients in the afternoon (id. ,r 8).
Appellants also cite Heijl, 6 as evidence that "each millimeter of
mercury of decreased IOP [intraocular pressure] relates to an approximately
10% lowered risk of developing glaucoma" and that the greater reduction in
IOP of the preservative free composition of the claims, as compared to the
claimed composition, is therefore a significant improvement. Appeal Br. 12.
It is well settled that "[ w ]hen an applicant demonstrates substantially
improved results ... and states that the results were unexpected, this should
6 Anders Heijl et al., Reduction of Intraocular Pressure and Glaucoma
Progression, 120 Arch. Ophthalmol. 1268-1279 (2002).
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suffice to establish unexpected results in the absence of evidence to the
contrary." In re Soni, 54 F.3d 746, 751 (Fed. Cir. 1995).
In the present case, the Examiner does not dispute that the evidence of
unexpected results submitted by Appellants demonstrates a significant or
substantial improvement. See Ans. 6. ("The [E]xaminer acknowledges that
a small decrease in IOP [is] clinically significant.").
The Examiner, however, finds that Appellants' evidence is not
commensurate in scope with the claimed subject matter because "the claims
of the instant application are not drawn to any time points. Therefore, at the
time points between 2 and 8 hours there is no advantage shown by the
declaration." Ans. 6.
We are not persuaded. Our reviewing court has explained that, to
demonstrate that a product, such as a chemical compound, has unexpected
properties sufficient to overcome a prima facie showing of obviousness, a
patent applicant need not "produce superior results in every environment in
which the compound may be used. To be patentable, a compound need not
excel over prior art compounds in all common properties." In re Chupp, 816
F.2d 643, 646 (Fed. Cir. 1987). Instead, "[e]vidence that a compound is
unexpectedly superior in one of a spectrum of common properties, as here,
can be enough to rebut a primafacie case of obviousness." Id.
Thus, the Examiner's position, that the undisputedly significant
improvement shown by Appellants is insufficient to show nonobviousness
because the improvement was not shown throughout the entire post-
administration period, conflicts with the holding in Chupp, 816 F .2d at 646-
647 (rejection of claims to herbicidal compound reversed over showing of
unexpected properties based on single method of use).
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The Examiner, moreover, does not identify, nor do we discern, any
evidence of record suggesting that the results demonstrated in the Shen
Declaration would have been expected. Rather, the Examiner rejects the
evidence submitted by Appellants because the preservative free single use
compositions suggested by Chang and Schiffman would inherently have the
same properties as the properties of the claimed compositions demonstrated
in the Shen Declaration. See Ans. 5 ("Since the composition of Chang et al.
in claims 1-3 and 13-15 does not have any preservatives and since
Schiffman's ... single use composition also does not have any
preservatives, such compositions are expected to have the same efficacy as
the claimed composition."), and 6 ("[ A ]s it was discussed previously certain
claims of Chang et al. and the single use of Schiffman' s ... composition
also [does] not have any preservatives.").
We are not persuaded. The Examiner's rejection is for obviousness,
not anticipation. Accordingly, it might be true that claims 1-3 and 13-15 of
Chang, when viewed in light of the teachings discussed above at
paragraph 11 of Chang and/or page 3 of Schiffman, suggest preparing a
preservative free version of Chang's composition described at paragraph 19.
It is undisputed, however, that the disclosures in claims 1-3 and 13-
15 of Chang, and page 3 of Schiffman, do not describe a discrete
composition that anticipates any of Appellants' claims. The Examiner's
rejection of Appellants' evidence of unexpected results, therefore,
improperly relies on the supposedly inherent properties present in a
hypothetical composition which is not actually described in the prior art.
On the current record, moreover, it is undisputed that the Shen
Declaration compared the closest prior art, Chang's composition described
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at ,r 19, to a preservative free version of that composition encompassed by
the rejected claims, which is all that is required. See Millennium
Pharmaceuticals, Inc. v. Sandoz, Inc., 862 F.3d. 1356, 1368 (Fed. Cir. 2017)
("[W]hen unexpected results are used as evidence of nonobviousness, the
results must be shown to be unexpected compared with the closest prior
art.") ( citation omitted).
While the Examiner appears to propose that Appellants must compare
the claimed invention to the invention suggested by the prior art, our
reviewing court has squarely rejected that proposition. See id. ("Unexpected
results are shown in comparison to what was known, not what was
unknown. . . . The applicant is not required to create prior art, nor to prove
that his invention would have been obvious if the prior art were different
than it actually was.") (quotation marks and citation removed).
Accordingly, for the reasons discussed, although we agree with the
Examiner that Chang and Schiffman support a prima facie case of
obviousness, Appellants persuade us that the evidence ofundisputedly
unexpected results is sufficient to outweigh the evidence of prima facie
obviousness. We, therefore, reverse the Examiner's obviousness rejection.
SUMMARY
We reverse the Examiner's rejection of claims 1-11 under 35 U.S.C.
§ 103(a) for obviousness over Chang and Schiffman.
REVERSED
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