Ex Parte Wedekind et al

Patent Trial and Appeal Board

Apr 25, 2017

12307425 (P.T.A.B. Apr. 25, 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.
12/307,425 11/11/2009 Karen Joy Wedekind 7602-00-HL 3149
23909 7590 04/27/2017
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
CHOI, FRANK I
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
04/27/2017 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):
Paten t_Mail @ colpal. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KAREN JOY WEDEKIND and CLAIDIA ANN KIRK
Appeal 2016-004106
Application 12/307,425
Technology Center 1600
Before, DEMETRA J. MILLS, ERIC B. GRIMES, and RICHARD J.
SMITH, Administrative Patent Judges.
MILLS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
WE AFFIRM.
Appeal 2016-004106
Application 12/307,425
STATEMENT OF CASE
According to the Specification, page 1, “This invention relates
generally to compositions and methods for preventing or treating
cardiovascular diseases and particularly to compositions and methods for
preventing or treating cardiovascular diseases in felines with
hyperthyroidism.”
The following claim is representative.
1. A method for treating a cardiovascular disease in a feline with
hyperthyroidism and in need of said treating comprising feeding the feline a
composition that comprises
from about 0.07 to less than about 1 mg/kg iodine on a dry matter basis
from about 0.1 to about 1.3 mg/kg selenium on a dry matter basis
from about 31 to about 35% protein on a dry matter basis wherein the
protein comprises at least about 75% vegetable protein
wherein the feeding step is implemented until a statistically significant
improvement is obtained in the measurements for interventricular septum,
left ventricular end dimension and left ventricular posterior wall.
Grounds of Rejection
Claims 1—3, 5, 6, 8—15, 29—32, and 34—38 are rejected under pre-AIA
35 U.S.C. 103(a) as being unpatentable over WO 2004/112499 (cited by
Appellant as Wedekind (hereinafter either Wedekind or WO ‘499) in view of
The Cat Clinic of Roswell, Allen, Feline Advisory Bureau, Liu et al. and
Remington’s.
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Application 12/307,425
FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Final Action at
pages 2—15.
Cited References
Wedekind WO 2004/112499 A1 Dec. 24, 2004
Liu et al., “Hypertrophic cardiomyopathy and hyperthyroidism in the
cat,” JAVMA, Vol. 185 No. 1, pp. 52-57 (1984).
Remington’s Pharmaceutical Sciences, 17th Ed., pp. 141, 1772-1773,
1786, 1794, Alfonso Gennaro, ed., Mack Publishing Co. (1985).
The Cat Clinic of Roswell, “Feline Cardiomyopathy,” (2002).
Allen, Echocardiography as a Research and Clinical Tool in Vetrinary
Medicine, Can. Vet. J., Vol. 23, pp. 313—316 (1982).
Feline Advisory Bureau, “Hyperthyroidism in Cats,” (2004).
PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office).
“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRIntI Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
“It is a general rule that merely discovering and claiming a new
benefit of an old process cannot render the process again patentable.” In re
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Application 12/307,425
Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). “Newly discovered results
of known processes directed to the same purpose are not patentable because
such results are inherent.” Bristol Myers Squibb v. Ben-Venue Laboratories,
246 F.3d 1368 (Fed. Cir. 2001).
If, however, the body of the claim fully and intrinsically sets
forth the complete invention, including all of the limitations, and the
preamble offers no distinct definition of the claimed invention’s
limitations, but merely states, for example, the purpose or the intended
use of the invention, then the preamble is of no significance to claim
construction because it cannot be said to constitute or explain a claim
limitation.
Pitney Bowes, Inc. v. Hewlett Packard Co., 182 F.3d 1298, 1305 (Fed. Cir.
1999).
“Where ... a patentee defines a structurally complete invention in the
claim body and uses the preamble only to state a purpose or intended use for
the invention, the preamble is not a claim limitation.” Rowe v. Dr or, 112
F.3d 473, 478 (Fed. Cir. 1997).
Obviousness Rejection
The Examiner finds that Wedekind teaches “a reduced-selenium and
reduced-iodine packaged feline diet composition, which comprises selenium
in an amount equal or less than about 0.65 mg/kg on a dry weight basis and
iodine in an amount equal or less than about 1 mg/kg on a dry weight basis,
that nutrients can be provided in a form of cat food.” Ans. 2. In addition,
Wedekind discloses “a cat food containing 0-5% animal protein, 30-35%
vegetable protein, 0.2 mg/kg selenium and 0.2 mg/kg iodine on a dry matter
basis which is used to treat hyperthyroidism in cats resulting in significant
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decreases in levels of thyroid hormones, T3 and T4 (Paragraphs 0005—0008,
0020, 0021, 0034—0042).” Ans. 3.
The Cat Clinic of Roswell discloses
that hypertrophic cardiomyopathy exhibits increased cardiac muscle
mass and decreased space in the ventricular chambers, ... that
hyperthyroidism can cause cardiomyopathy, that treatment of
hyperthyroidism can result in the improvement or reversal of the heart
disease and that treatment of the hyperthyroidism can be combined
with treatment with diuretics, beta blockers, calcium channel blockers
and ACE inhibitors for treatment of the heart disease and that specific
diets can be used for the pet’s condition (pages 1—3).
Ans. 3. Feline Advisory Bureau discloses that
cats with hyperthyroidism are also predisposed to development of
hypertrophic cardiomyopathy which may require additional
treatment but once the underlying hyperthyroidism has been
controlled the hypertrophic cardiomyopathy will usually improve or
even resolve completely and that treatment includes anti-thyroid
drug therapy for reducing the levels of thyroid hormone (Pages 1, 2).
Ans. 3^4.
The Examiner concludes that
one of ordinary skill in the art would have been motivated to modify
the prior art as above with the expectation that treatment of the
hyperthyroidism with the composition of WO ‘499 [Wedekind] would
treat cardiovascular diseases caused by said hyperthyroidism,
including cardiac hypertrophy and hypertrophic cardiomyopathy, as
treatment of the underlying hyperthyroidism would reduce the
excessive amount of thyroid hormones resulting in eventual reversal
of said cardiovascular diseases...
Ans. 6—7.
Appellants contend that
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Treatment of hyperthyroidism cannot be construed as or deemed to be
equivalent to Appellants’ claimed methods for treatment of
cardiovascular disease since the art actually teaches not only that
cardiovascular disease can develop in non-hyperthyroid felines but
also that hyperthyroidism does not necessarily and inevitably lead to
cardiovascular disease. Moreover, Appellants also submit that there
was nothing in that art that suggested that Appellants’ presently
claimed compositions would be useful for the treatment of
cardiovascular disease in a feline with hyperthyroidism.
Br. 4. Appellants further argue that
The present invention clearly demonstrates that the recited food
compositions (see, e.g. food compositions A to C in paragraph
[0063] to [0066]) significantly improve cardiac function
as indicated by the ultrasound measurements of intraventricular
hypertrophy, left ventricular posterior wall hypertrophy, and left
ventricular diastolic diameter (see Table 4). Thyroid function is also
advantageously improved with these compositions (Table 4). In
contrast, none of the cited art documents provide any data relating to
cardiac parameters, and moreover, none of those references provide
any indication of the effects of iodine and selenium, in combination
with vegetable protein on cardiac function in felines with
hyperthyroidism.
Br. 5. Appellants argue that, ‘“499 [Wedekind] suggests that administration
of the diet of paragraph [0035] for an extended period of time has no
significant effect on cardiovascular function.” Br. 6.
ANALYSIS
We agree with the Examiner’s fact finding, statement of the rejection
and responses to Appellants’ arguments as set forth in the Answer. We find
that the Examiner has provided evidence to support a prima facie case of
obviousness. Appellants do not argue any individual claims separately, thus
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Application 12/307,425
we select claim 1 as representative claim. Arguments not made are waived.
We provide the following additional comment to the Examiner’s argument
set forth in the Final Rejection and Answer.
Appellants argue that they
have discovered an approach to the prevention and/or treatment
of cardiovascular disease in hyperthyroid cats in which the cardiac
improvement is not simply ancillary to treatment of hyperthyroidism,
a result that is surprising and unexpected to those of ordinary skill in
the art. Appellants’ discovery is particularly relevant since it is clear
that hyperthyroidism and cardiovascular disease can occur
independently of one another and each can occur in the absence of the
other.
Br. 4. While Appellants argue that the cardiac improvement is not simply
ancillary to treatment of hyperthyroidism (Br. 4), that is not the scope of
pending claim 1. While cardiovascular disease can develop in non­
hyperthyroid felines, the treatment of cardiovascular disease in non­
hyperthyroid felines is not within the scope of the pending claims, which
describe treatment of a cardiovascular disease in a feline with
hyperthyroidism.
Claim 1 entails a single method step of: feeding a feline with
hyperthyroidism, a composition that comprises: from about 0.07 to less than
about 1 mg/kg iodine on a dry matter basis, from about 0.1 to about 1.3
mg/kg selenium on a dry matter basis, from about 31 to about 35% protein
on a dry matter basis wherein the protein comprises at least about 75%
vegetable protein. Wedekind discloses a similar feed composition (Ans. 2-
3) and method step (Example 1, p. 13). Wedekind discloses that treatment
with low selenium, low iodine feed resolves hyperthyroidism and results in
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T3 and T4 levels in the normal range (Table 5,142). “It is a general rule
that merely discovering and claiming a new benefit of an old process cannot
render the process again patentable.” In re Woodruff, 919 F.2d at 1578. If a
reference discloses the very same methods, then the particular benefits must
naturally flow from those methods even if not recognized as benefits at the
time of the reference’s disclosure. Compare, Perricone v. Medicis Pharm.
Corp., 432 F.3d 1368, 1379 (Fed. Cir. 2005).
Furthermore, the Examiner establishes that it is well known in the art
from the Cat Clinic of Roswell that, “[hjyperthyroidism is the most treatable
cause of cardiomyopathy [in felines] since complete resolution of the heart
disease is possible if diagnosed and treated early.” P. 2. Similarly, the
Feline Advisory Board discloses that cats with hyperthyroidism are
predisposed to hypertrophic cardiomyopathy. P. 1.
Feline Advisory Board establishes that resolution of hypertrophic
cardiomyopathy is a known, concomitant benefit of treatment of
hyperthyroidism in felines. “[0]nce the underlying hyperthyroidism has
been controlled the hypertrophic cardiomyopathy will usually also improve,
or even resolve completely.” P. 1. Thus, one of ordinary skill in the art at
the time of the invention would have expected that treatment of
hyperthyroidism in felines and reducing thyroid hormone levels to normal
with a feed as disclosed in Wedekind, would provide a concomitant benefit
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of resolution of cardiovascular disease, including hypertrophic
cardiomyopathy.1
Finally, Appellants argue that the feline feed compositions used in the
claimed method “significantly improve cardiac function” (Br. 5).
Appellants provide no comparative evidence with the closest prior art feed
compositions of Wedekind to support unexpected results.
The obviousness rejection is affirmed for the reasons of record.
CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejections,
which are affirmed for the reasons of record.
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
1 We remind Appellants that the pending rejection is an obviousness
rejection, and thus not controlled by the anticipation rejection facts of
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368 (Fed. Cir. 2005).
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