Ex Parte Lomaga

Patent Trial and Appeal Board

Feb 10, 2017

12452838 (P.T.A.B. Feb. 10, 2017)

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.
12/452,838 03/25/2010 Mark Andrew Lomaga 076308.00000 9651
26712 7590
HODGSON RUSS LLP
THE GUARANTY BUILDING
140 PEARL STREET
SUITE 100
BUFFALO, NY 14202-4040
EXAMINER
VU, JAKE MINH
ART UNIT PAPER NUMBER
1618
NOTIFICATION DATE DELIVERY MODE
02/14/2017 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):
ipdocketing @ hodgsonrus s. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MARK ANDREW LOMAGA.1
Appeal 2016-003407
Application 12/452,838
Technology Center 1600
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
pharmaceutical composition which have been rejected for failing to satisfy
the written description requirement and as obvious. We have jurisdiction
under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The present invention is directed to a pharmaceutical composition
comprising a phenylpropionate, an acetanilide and a sympathomimetic drug
1 Appellants identify the Real Party in Interest as Kingsway Pharmaceuticals
Inc. Appeal Br. 2.
Appeal 2016-003407
Application 12/452,838
as well as a pharmaceutically acceptable carrier. Spec. 11. The
compositions of the invention are useful in treating such symptoms as pain,
headache, fever, nasal congestion, sinus congestion, runny nose, sore throat,
myalgia, or ear fullness. Spec. 1 54.
Claim 49 is the only claim on appeal and reads as follows:
49. A pharmaceutical formulation comprising ibuprofen,
acetaminophen, phenylephrine, and a pharmaceutically
acceptable carrier, wherein the ratio of acetaminophen to
ibuprofen is 0.8125: 1 to 2.5: 1 and phenylephrine is present at
from 1.10 to 16.13% by weight of the total mass of ibuprofen,
acetaminophen, and phenylephrine.
Claim 49 stands rejected as follows:
Claim 49 has been rejected under 35 U.S.C. § 112, first paragraph for
failing to comply with the written description requirement.
Claim 49 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Swann.2
Claim 49 has been rejected under 35 U.S.C. § 103(a) as unpatentable
over Swann in view of FD&C.3
THE WRITTEN DESCRIPTION REJECTION
Issue
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claim 49 fails to comply
with the written description requirement.
2 Swann et al., US 8,580,855 B2, issued Nov. 12, 2013 (“Swann”).
3 Facts and Comparisons, Drug Facts and Comparisons 2005, 59th Ed. (2005)
(“FD&C”).
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Application 12/452,838
The Examiner finds that the specification does not provide a written
description or set forth the metes and bounds of the phrase “wherein the ratio
of acetaminophen to ibuprofen is 0.8125:1 to 2.5:1 and phenylephrine is
present at from 1.10 to 16.13%.” Final Act. 3. The Examiner finds that the
values are arbitrary and that the specification does not disclose the values or
any way to calculate the values. Final Act. 4.
Appellant argues that while the values are not recited literally in the
Specification, one skilled in the art would understand from the values recited
in the Specification that Appellant had the invention is his possession.
Appeal Br. 5—6. Appellant argues that the claimed ranges are supported by
disclosure of both endpoints as well as points between. Appeal Br. 6.
Appellant goes on to argue that the values are not arbitrary and that one
skilled in the art would be able to calculate the ratios from the data provided.
Appeal Br. 7—8.
We find that Appellant has the better position. The written
description requirement does not require that the invention be described in
haec verba but only that the description convey to one skilled in the art that
the inventor had in his possession the claimed invention. In re Herschler,
591 F.2d 693, 700-701 (CCPA 1979). We agree with Appellant that the data
recited at page 21 of the Specification would convey to one skilled in the art
that Appellant had the claimed invention in his possession. Appeal Br. 5.
We disagree with the Examiner’s argument that the ratios are
arbitrary. Ans. 4. As Appellant points out, the values are derived from
specific formulations recited in the Specification. Appeal Br. 7.
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Application 12/452,838
The Examiner also argues that the Specification gives no guidance as
to how to calculate the ratios recited in the claims. Ans. 4. We are
unpersuaded. As Appellant points out, calculating the ratios is well within
the capability of one skilled in the art and need not be disclosed in the
Specification. Appeal Br. 7—8
The Examiner argues that the claimed ratios embrace amounts of the
components not exemplified in the Specification. Ans. 8. We remain
unpersuaded. Such a detailed disclosure of “the exact chemical component
of each combination that falls within the range claims” is not required. See
Union Oil Co. of Calif. V. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed
Cir. 2000).
We conclude that the Examiner has failed to establish by a
preponderance of the evidence that claim 49 fails to satisfy the written
description requirement.
THE OBVIOUSNESS REJECTIONS
Swann
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the Evidence that claim 49 would have
been obvious over Swann under 35 U.S.C. § 103(a).
The Examiner finds that Swann teaches a synergistic combination of
ibuprofen and acetaminophen. Final Act. 5. The Examiner finds that Swann
teaches that the composition may also contain a decongestant such as
phenylephrine. Id. With respect to the ratios recited in claim 49, the
Examiner finds that while Swann does not recite the specific ratios, the
amounts of the three components are parameters that one skilled in the art
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Appeal 2016-003407
Application 12/452,838
would routinely optimize. Id. The Examiner concludes that “absent some
demonstration of unexpected results from the claimed parameters, this
optimization of ingredient amount would have been obvious at the time of
Applicant’s invention.” Final Act. 5—6.
Appellant contends that Swann does not provide any guidance as to
the amount of phenylephrine to use relative to the amounts of the other
components. Appeal Br. 8. Appellant contends that Swann does not show
that the amount of phenylephrine is a result effective variable. Appeal Br.
9-10.
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellant’s arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. We provide the following additional comment to the
Examiner’s argument set forth in the Final Rejection and Answer.
Swann teaches a synergistic combination of ibuprofen and
acetaminophen. Swann, col.l, 11. 17—19. Swann also teaches that the
composition can also comprise an active ingredient such as phenylephrine.
Swann col. 6,11. 18—20. Swann teaches that the active ingredient, such as
phenylephrine is present
in a therapeutically effective amount, which is an amount that
produces the desired therapeutic response upon oral
administration and can be readily determined by one skilled in
the art. In determining such amounts, the particular active
ingredient being administered, the bioavailability characteristics
of the active ingredient, the dosing regimen, the age and weight
of the patient, and other factors must be considered, as known
in the art.
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Application 12/452,838
Swann col. 6,11. 30-39.
While Swan might not disclose the specific amounts of phenylephrine
recited in the claims, we agree with the Examiner that determining the
appropriate amount of phenylephrine would have been a matter of
optimization, especially given the teachings of Swann recited above, that
therapeutic dosages may be ascertained routinely by an ordinary artisan.
Ans. 9.
We conclude that the Examiner has established by a preponderance of
the evidence that claim 49 would have been obvious over Swann under 35
U.S.C. § 103(a)
Swann Combined with DF&C
The issue with respect to this rejection is whether the Examiner has
shown by a preponderance of the evidence that claim 49 would have been
obvious over Swann combined with DF&C.
The Examiner reiterates the findings regarding Swann and goes on to
find that DF&C teaches that the art had known to use decongestants and
analgesics/antipyretics together. Final Act. 6. The Examiner reiterates his
conclusion that it would have been a matter of routine optimization to use
the three components in the amounts recited in the claims. Final Act. 7.
Appellant repeats the argument made in connection with Swann
discussed above. Appeal Br. 11. Appellant also argues that DF&C does not
teach that the amount of phenylephrine can be varied with respect to the
amounts of ibuprofen and acetaminophen. Appeal Br. 12. Appellant argues
that DF&C does not teach that the amount of phenylephrine is a result-
effective variable.
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Appeal 2016-003407
Application 12/452,838
For the reasons stated above, we do not find Appellant’s arguments
persuasive. Swann alone provides sufficient teachings with respect to
optimizing the three components. We agree with the Examiner that one
skilled in the art using the teaching of Swann and FD&C would be
motivated to optimize the amounts of ibuprofen and acetaminophen to
control pain or for their antipyretic effect and optimize the amount of
phenylephrine to control congestion. Ans. 9—10.
We find that the Examiner has established by a preponderance of the
evidence that claim 49 would have been obvious over Swann combined with
DF&C under 35 U.S.C. § 103(a).
SUMMARY
We reverse the rejection of claim 49 under 35 U.S.C. § 112, first
paragraph.
We affirm both rejections of claim 49 under 35 U.S.C. § 103(a).
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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