Ex Parte Kim et al

Patent Trial and Appeal Board

Sep 20, 2016

12159678 (P.T.A.B. Sep. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/159,678 10/30/2008
23909 7590 09/22/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Gene Friesen Kim
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.
8080-00-HL 1469
EXAMINER
COOK, LISA V
ART UNIT PAPER NUMBER
1678
NOTIFICATION DATE DELIVERY MODE
09/22/2016 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):
Patent_Mail@colpal.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GENE FRIESEN KIM, RYAN MICHAEL YAMKA,
WILLIAM DAVID SCHOENHERR, PHILIP WILLIAM TOLL, and
CHERYL CHRISTINE MILLER 1
Appeal2014-009908
Application 12/159,678
Technology Center 1600
Before ERIC B. GRIMES, TA WEN CHANG, 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
method for treating an animal for obesity which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
The present invention is directed to
1 Appellants identify the Real Party in Interest as Hill's Pet Nutrition, Inc.
Br. 2.
Appeal2014-009908
Application 12/159,678
a method for diagnosing a body weight condition or
predisposition thereto in an animal. The method comprises
determining observed level(s) of at least one biomarker in a
tissue or biofluid sample from the animal and comparing the
observed level(s) to reference level(s) for the biomarker,
wherein the observed level(s) relative to the reference level(s)
are individually or collectively indicative of the body weight
condition or predisposition.
Spec. i-f 7.
Claims 1-15, 19, and 20 are on appeal. Claims 1 and 19 are
illustrative and read as follows:
1. A method for prophylactically treating an animal for an
obese condition, comprising the steps of:
diagnosing a predisposition to the obese condition in the
animal by:
a) determining observed level(s) of at least one
biomarker in a tissue or biofluid sample from the animal; and
b) comparing the observed level( s) to reference level( s)
for the biomarker; wherein the observed level(s) relative to the
reference level(s) are individually or collectively indicative of
the predisposition to the obese condition, and wherein said
obese condition is defined by body fat content of the animal as
a percentage of total body weight of the animal;
c) selecting a regimen appropriate to the obese condition;
and
d) continuing the regimen.
19. A method for treating an animal for an obese condition,
comprising the steps of:
a) detecting the onset of the obese condition in an animal
by monitoring at least one biomarker in the animal over a
period by:
i) determining, at each of a plurality of time points
during the period, observed level(s) of the biomarker in a
tissue or biofluid sample from the animal, and
2
Appeal2014-009908
Application 12/159,678
ii) comparing the observed level(s) to reference
level(s) for the biomarker; wherein onset is detected if, at
any time point, the observed level(s) relative to the
reference level(s) are individually or collectively
indicative of the obese condition, and wherein said obese
condition is defined by body fat content of the animal as
a percentage of total body weight of the animal;
b) selecting a regimen appropriate to the obese condition; and
d) continuing the regimen.
The claims stand rejected as follows:
Claims 1, 2, 4--15, 19, and 20 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over van Citters2 in view of Sagawa3 and in further view of
Daminet. 4
Claims 3---6, 19, and 20 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Jeusette5 in view of Sagawa in further view ofDaminet.
2 Van Citters et al., Elevated Glucagon-Like Peptide-1-(7-36)-Amide, but
Not Glucose, Associated with Hyperinsulinemic Compensation for Fat
Feeding, 87 J. Clinical Endocrinology and Metabolism 5191 (2002) ("van
Citters"). The Examiner refers to this reference as Gregg et al. Gregg is the
first name of the first listed author, van Citters.
3 Sagawa et al., Correlation between plasma leptin concentration and body
fat content in dogs, 63 Am. J. Vet. Res. 7 (2002) ("Sagawa").
4 Daminet et al., Evaluation of Thyroid Function in Obese Dogs and in Dogs
Undergoing a Weight Loss Protocol, 50 J. Vet. Med. 213 (2003)
("Daminet").
5 Jeusette et al., Influence of obesity on plasma lipid and lipoprotein
concentrations in dogs, 66 Am. J. Vet. Res. 81 (2005) ("Jeusette").
3
Appeal2014-009908
Application 12/159,678
I
Issue
In rejecting claims 1, 2, 4--15, 19, and 20 the Examiner finds that van
Citters discloses methods and models for evaluating canine weight and
insulin resistance. Final Act. 2. The Examiner finds that van Citters teaches
measuring biomarkers associated with obesity. Final Act. 2-3. The
Examiner finds that at least one biomarker, GLP-1, increased by feeding a
fat rich diet to dogs. Final Act. 3. The Examiner finds that Sagawa teaches
a method of detecting biomarkers such as leptin in dog fat measurements.
The Examiner also finds that Sagawa teaches that body fat content is linked
to elevated leptin. Final Act. 4. The Examiner finds that Sagawa teaches
that the use of leptin and body content calculations were successful in
evaluating obesity in small animals. Id. The Examiner goes on to find that
Daminet teaches methods for treating an obese condition. Final Act. 5. The
Examiner concludes that
Id.
[i]t would have been prima facie obvious to one of ordinary
skill in the art to employ methods of treating obese animals as
taught by Daminet et al. in the animal fat biomarker
measurements exemplified by [van Citters] in view of Sagawa
et al. because Daminet et al. taught that obesity and weight loss
had an effect on measured biomarkers. See pages 217-218. One
of ordinary skill in the art would have been motivated to utilize
methods of treatment in order to discover cures for obesity.
Appellants contend that the references do not teach diagnosing a
predisposition to obesity nor do they teach prophylactically treating an
animal for an obese condition. Br. 4.
4
Appeal2014-009908
Application 12/159,678
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that claim 1 would have
been obvious over van Citters combined with Sagawa and Daminet under 35
U.S.C. § 103(a).
Findings of Fact
We adopt as our own the Examiner's findings and analysis. The
following findings are included for emphasis and reference convenience.
FPL In van Citters' study, obesity was induced in dogs by feeding
them a diet supplemented with bacon grease. Van Citters 5191.
FF2. After twelve weeks, the dogs were tested for the presence
certain biomarkers including glucagon-like peptide-I (GLP-1 ). Van Citters
5192.
FF3. A comparison of GLP-1 levels in dogs fed a high fat diet with
the levels in dogs fed a normal diet revealed a 2.5 fold increase in GLP-1 in
the dogs fed that high fat diet. Van Citters 5194 Table 3.
FF4. Sagawa measured both body fat content and leptin levels in
both overweight and normal weight dogs. Sagawa 7-9.
FF5. Sagawa determined that there was a good correlation between
body fat content and leptin levels. Sagawa 9.
FF6. Sagawa teaches that "the measurement of plasma leptin would
be useful for assessment of adiposity and obesity." Id.
FF7. Daminet teaches the use of a calorie restricted diet to effect
weight loss in obese dogs. Daminet 214.
FF8. Daminet teaches that "[ d]iet changes are the mainstay in the
treatment of obesity." Daminet 217.
5
Appeal2014-009908
Application 12/159,678
Principles of Law
"In determining whether obviousness is established by combining the
teachings of the prior art, the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art." In re
GPAC Inc., 57 F.3d 1573, 1581 (Fed. Cir. 1995) (internal quotations
omitted).
"[W]hile an analysis of obviousness always depends on evidence that
supports the required Graham factual findings, it also may include recourse
to logic, judgment, and common sense available to the person of ordinary
skill that do not necessarily require explication in any reference or expert
opinion." Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324, 1329
(Fed. Cir. 2009).
The preamble of a claim does not further limit claims if it merely
states a purpose or intended use of subject matter. The language in a
preamble will be given effect if it is "necessary to give life, meaning, and
vitality to the claims." Kropa v. Robie, 187 F.2d 150, 152 (CCPA 1951).
Analysis
Claims 1 and 19 are representative of the rejected claims and are
directed to methods for treating an animal for an obese condition by
diagnosing a predisposition to (claim 1) or detecting the onset of (claim 19)
the obese condition by determining the level of at least one biomarker, then
selecting and continuing an appropriate regimen.
We agree with the Examiner that the subject matter of claims 1 and 19
would have been obvious to one skilled in the art at the time the invention
6
Appeal2014-009908
Application 12/159,678
was made. Both van Citters and Sagawa teach measuring and comparing
biomarker levels in both normal and obese animals, which corresponds with
the limitations of "diagnosing a predisposition" and "detecting the onset of
an obese condition." Ans. 6; FFl---6. In addition, Sagawa specifically
teaches that leptin levels can be used in assessing adiposity and obesity.
FF6. Daminet teaches that placing an animal on a caloric-restricted diet
reduces the animal's weight. FF7 and 8. We agree with the Examiner's
conclusion that one skilled in the art would have been motivated to combine
the teachings of the references to detect and treat obesity. Final Act. 5.
Appellants contend that the references do not teach or suggest
prophylactically treating an obese condition. Br. 4. We are unpersuaded.
As the Examiner noted, the term "prophylactically treating" appears in the
preamble. Ans. 8. We agree with the Examiner that the preamble in this
case merely recited the purpose of the claimed process and is therefore not
accorded any patentable weight. Ans. 8. And, even if preamble of claim 1
was considered a limitation, it would have been obvious to put an animal
that was getting fat---even if not yet obese---on Daminet's calorie-restricted
diet because Daminet states that obesity is a "common nutritionally related
problem in dogs." Daminet 213.
Appellants also argue that van Citters teaches that the animals
exhibited an increase is muscle mass and does not report a change in body
fat. Br. 4. Appellants argue that van Citters cannot teach the claimed
method. Id. We are unpersuaded. As the Examiner noted, increased body
fat in the animal before treatment is not a limitation of claim 1. Ans. 7.
7
Appeal2014-009908
Application 12/159,678
Moreover, Sagawa teaches the correlation between biomarkers and body fat,
remedying the shortcoming of van Citters. Ans. 7.
Finally, Appellants argue that Daminet fails to cure the deficiencies of
van Citters in that Daminet related to measurement of thyroid function in
lean and obese dogs. Br. 4. Appellants also argue that Daminet induced
obesity in dogs and is not directed to prophylactically treating an obese
condition. Id. We agree with the Examiner that Daminet would have made
obvious prophylactically treating an animal in that Daminet teaches placing
obese dogs on a caloric-restriction diet to reverse their condition; therefore,
it would have been obvious to treat dogs starting to get fat with the same diet
to prevent obesity. Ans. 6.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 1 and 19 would have been obvious over van Citters
combined with Sagawa and Daminet under 35 U.S.C. § 103(a).
Claims 2, 4--15, and 20 have not been argued separately and therefore
fall with claims 1 and 19. 37 C.F.R. § 41.37(c)(l)(iv).
II
Issue
In rejecting claims 3---6, 19, and 20 the Examiner finds that Jeusette
discloses methods for measuring obesity in dogs by detecting plasma lipid
and lipoprotein concentrations. 6 Final Act. 5. The Examiner also finds that
6 In the Answer, the Examiner explained that "claim 1 was inadvertently
omitted from the rejection [over Jeusette, Sagawa, and Daminet]." (Ans. 9.)
8
Appeal2014-009908
Application 12/159,678
Sagawa teaches methods of detecting biomarkers such as leptin in body fat
measurements. Final Act. 6. The Examiner goes on to find that Daminet
teaches methods for treating an obese condition by placing an animal on a
caloric restriction. Final Act. 7. The Examiner concludes that
[i]t would have been prima facie obvious to one of ordinary
skill in the art to employ methods of treating obese animals as
taught by Daminet et al. in the animal fat biomarker
measurements exemplified by Jeusette et al. in view of Sagawa
et al. because Daminet et al. taught that obesity and weight loss
had an effect on measured biomarkers. See pages 217-218. One
of ordinary skill in the art would have been motivated to utilize
methods of treatment in order to discover cures for obesity.
Final Act. 8.
Appellants contend none of the references disclose or suggest "a
method for prophylactically treating an animal for an obese condition, by
diagnosing a predisposition to the condition as recited in claim 1, or a
method for treating an animal for an obese condition, comprising detecting
the onset of the obese condition in an animal as recited in claim 19." Br. 5.
The issue with respect to this rejection is whether the Examiner has
established by a preponderance of the evidence that the claims would have
been obvious over Jeusette combined with Sagawa and Daminet under
35 U.S.C. § 103(a).
As the Examiner did not properly list the rejection of claim 1 over these
prior art references under "New Ground of Rejection," however, we do not
consider the rejection of claim 1 over Jeusette, Sagawa, and Daminet in this
appeal.
9
Appeal2014-009908
Application 12/159,678
Findings of Fact
FF9. Jeusette discloses measuring plasma lipids in both lean and
obese dogs with the obese dogs having higher plasma lipid concentrations
than lean dogs. Jeusette 81.
FFlO. Jeusette discloses that diet modification resulted in beneficial
effects on plasma lipid and leptin concentrations. Jeusette 81.
FFl 1. The dogs tested by Jeusette were between one and nine years
old. Jeusette 82.
Analysis
Claims 3 and 19 are representative of the rejected claims. Claim 3
depends from claim 1 discussed above and adds the limitation that the
animal be "up to about one year of age." Br. 7 (Claims Appendix).
We agree with the Examiner that the subject matter of claim 3 would
have been obvious at the time the invention was made. Jeusette teaches the
detection level ofbiomarkers in obese animals and comparing those
biomarker levels with the levels found in lean animals. FF9. Jeusette also
teaches that modifying the diet of the obese animals had a beneficial effect
on the levels of the biomarkers. FFlO. Sagawa teaches measuring and
comparing biomarker levels in both normal and obese animals which
corresponds with the limitations of "diagnosing a predisposition" and
"detecting the onset of the obese condition." Ans. 10. In addition, Sagawa
specifically teaches that leptin levels can be used in assessing adiposity and
obesity. FF6. Daminet teaches that placing an animal on a caloric-
restricted diet reduces the animal's weight. FF7 and 8. We agree with the
Examiner's conclusion that one skilled in the art would have been motivated
10
Appeal2014-009908
Application 12/159,678
to combine the teachings of the references to detect and treat obesity. Ans.
11.
Appellants argue that none of the references teach or suggest the
prophylactic treatment of an obese condition by either detecting a
predisposition to obesity or the onset of obesity. Br. 5. For the reasons
discussed above, we are unpersuaded.
Conclusion of Law
We conclude that the Examiner has established by a preponderance of
the evidence that claims 3 and 19 would have been obvious over Jeusette
combined with Sagawa and Daminet under 35 U.S.C. § 103(a).
Claims 4--6 and 20 have not been argued separately and therefore fall
with claims 3 and 19. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 1, 2, 4--15, 19, and 20 under
35 U.S.C. § 103(a) as unpatentable over van Citters in view of Sagawa and
in further view of Daminet.
We affirm the rejection of claims 3---6, 19, and 20 under 35 U.S.C.
§ 103(a) as unpatentable over Jeusette in view of Sagawa in further view of
Daminet.
11
Appeal2014-009908
Application 12/159,678
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
12