Ex Parte Friesen et al

Patent Trial and Appeal Board

Jun 10, 2016

12296148 (P.T.A.B. Jun. 10, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/296,148 0913012009
23909 7590 06/14/2016
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
FIRST NAMED INVENTOR
Kim Gene Friesen
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.
7856-00-HL 5032
EXAMINER
THOMAS, TIMOTHY P
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
06/14/2016 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 KIM GENE FRIESEN and RYAN MICHAEL YAMKA
Appeal2013-010096
Application 12/296,148
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FREDMAN, and
JACQUELINE T. HARLOW Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to compositions for enhancing
the antioxidant status of an animal. Appellants appeal from the Examiner's
final rejection of all the pending claims as obvious under 35 U.S.C. § 103.
We have jurisdiction under 35 U.S.C. § 134. The rejections are affirmed.
STATEMENT OF CASE
Claims 13-15, 18-21, 27, and 29-33 stand finally rejected by the
Examiner under 35 U.S.C. § 103(a) (pre-AIA) as obvious in view of Zicker
(WO 2005/006877 Al, published January 27, 2005), Douglass et al. (Feline
Plasma and Whole Blood Taurine Levels as Influenced by Commercial Dry
Appeal2013-010096
Application 12/296,148
and Canned Diets 121 J. NUTR. S 179-S 180 (1991) ("Douglass"), and
Heaton (GB 2 367 489 A, published April 10, 2002).
Claim 13 is representative and reads as follows:
13. A composition suitable for enhancing the antioxidant status
of an animal comprising from about 0.9 to about 1.5%
methionine, from about 1200 to about 1400 ppm taurine, from
about 120 to about 450 ppm vitamin C, and from about 700 to
about 2000 IU/kg vitamin E, all on a dry matter basis.
Appeal Br. 13 (Claims Appendix).
REJECTION
Each of claims 13 and 21 are directed to a composition comprising
specific amounts of 1) methionine, 2) taurine, 3) vitamin C, and 4) vitamin
E. The range of amounts for taurine, vitamin C, and vitamin E are the same
for claims 13 and 21, but the range for methionine is different in the two
claims (0.9% to 1.5%, 0.9% to 1.1 %, respectively) although overlapping.
The composition is recited in the claim preamble to be "suitable for
enhancing the antioxidant status of an animal."
The Examiner relied on Zicker for its description of a composition
with all four of the claimed antioxidants. Zicker describes feeding a cat a
diet comprising at least one sulfur-containing antioxidant (methionine,
taurine) and additional antioxidants from the group consisting of vitamin E,
vitamin C, and 1-camitine for the purpose decreasing deterioration of mental
capacity. Zicker i-f 5. The Examiner found that Zicker's composition
comprises methionine, vitamin C, and vitamin E in amounts which fall
within the claimed ranges. Final Rej. 3--4. The Examiner found that Zicker
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described feeding cats taurine, but the amount of taurine described in
Zicker' s diet is 0.2161 wt. % (or 2161 ppm) which is outside the claimed
range of "from about 1200 to about 1400 ppm taurine." Id. at 4--5. To meet
this deficiency in Zicker, the Examiner further cited Douglass and Heaton
for their teaching of taurine in amounts which within the claimed range. Id.
5---6.
The Examiner found that Douglass teaches that dry cat food should
contain 1000-1200 mg taurine/kg dry matter (1000-1200 ppm). Id. at 5.
The Examiner found that Douglass also described taurine an amount 1400
mg/kg which led to higher plasma taurine levels. Id. The Examiner
reasoned that one of ordinary skill in the art would have reduced the levels
of taurine in Zicker based on the recommended levels in Douglass. Id. at 7.
The Examiner also cited Heaton's disclosure of taurine in the diet of a
cat, where the Examiner converted Heaton' s suggested amounts of taurine to
800, 1200, and 1500 ppm in dry pet food. Id. at 6. The Examiner found the
amounts to be overlapping with those claimed and thus concluded the
claimed range was obvious. Id. at 6-7.
Appellants contend that the skilled worker would not have used
Zicker as a "starting point" because Zicker' s concern was with the
deterioration in mental activity of cats, not with an animal's antioxidant
status as recited for the claimed subject matter. Appeal Br. 5. For this
reason, Appellants also contend that Zicker is non-analogous art because the
problem of antioxidants addressed by the claims is different from
deterioration of mental activity in the Zicker publication. Id. Appellants
further argue that even if the skilled worker had started with Zicker, there
would have been no reason to reduce the taurine levels based on Douglass
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Application 12/296,148
and Heaton to have arrived at the amounts recited in claims. Id. at 7-8.
Finally, Appellants contend that the data presented in the Specification
establishes that adjusting the antioxidant levels was unpredictable. Id. at 9.
We address these arguments below.
Zicker
Appellants contend that Zicker would not have been a starting point
because it is concerned with a different problem and is non-analogous prior
art. Appeal Br. 5.
Prior art which is pertinent to the claimed invention is referred to as
"analogous" prior art. It is well-established that there are two criteria to be
applied when determining whether a reference is analogous prior art: ( 1)
whether the reference is from the "same field of endeavor" as the claimed
invention, and (2) if the reference is not within the same field of endeavor,
"whether the reference is reasonably pertinent to the particular problem with
which the inventor is involved." In re Clay, 966 F.2d 656, 658-59 (Fed. Cir.
1992). "References are selected as being reasonably pertinent to the
problem based on the judgment of a person having ordinary skill in the art."
In re Kahn, 441 F.3d 977, 986-87 (Fed. Cir. 2006). When neither criterion
is met, the reference is deemed "non-analogous" and is not considered
pertinent to the § 103 determination.
In this case, the Specification describes compositions for enhancing
the antioxidant status of animals, such as companion animals, dogs and cats.
Spec. i-fi-f l, 11, 14. The ingredients in the composition possess antioxidant
properties. Id. at i-f 16. The Specification teaches that the composition can
be administered as a food composition which "meets the ordinary nutritional
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requirements of the animal that it is being fed to." Id. at if 40. The
Specification also teaches that "composition of the invention meets
AAFCO's minimum nutrient level requirements for growth, reproduction,
and/or maintenance." Id.
Zicker describes "companion-animal diet compositions." Zicker if 2.
The compositions are for the specific purpose of "decreasing the
deterioration in mental activities such as that associated with aging." Id.
Zicker describes its invention as the discovery that "the presence of one or
more sulfur-containing antioxidants, in particular, sulfur-containing amino
acids in the diet of a cat inhibits, i.e. prevents or reverses deterioration of
mental capacity of the cat upon aging." Id. at if 4 (emphasis added). Zicker
teaches that sulfur containing antioxidants can be part of a normal diet that
meets the ordinary nutritional requirements to which sulfur containing
antioxidants are added. Id. at iii! 4, 10, 11, 13. Zicker teaches additional
antioxidants, as well, in the cat diet. Id. at if 5.
Both the Specification and Zicker are in the "same field of endeavor,"
namely, addressing the dietary and nutritional needs of companion animals.
Spec. if 40; Zicker iii! 4, 10, 11, 13. The Specification addresses the problem
of maintaining the antioxidant status, while Zicker's problem concerns
preventing mental deterioration of companion animals. However, Zicker -
as does the Specification - administers anti-oxidants. Zicker iii! 16 and 17;
Spec. if 16. Both the Specification and Zicker also formulate their
ingredients in normal dietary food compositions. Simply because Zicker and
the Specification address different problems, does not mean they are not in
the same field of endeavor. One of ordinary skill in the art would have
considered Zicker pertinent to the claimed subject matter because it is
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concerned with maintaining the health of companion animals, as is the
Specification, and it administers anti-oxidants and normal dietary
components, as described in the Specification. Accordingly, the weight of
the evidence does not support Appellants' contentions that Zicker is non-
analogous prior art to the claimed subject matter.
Appellants also contend that the skilled worker would not have started
with Zicker because Zicker is concerned with the mental deterioration of
companion animals, and not the antioxidant status of an animal as claimed.
Appeal Br. 5.
The claims are composition claims. The only time the term
"antioxidant status" appears in the claim is in the preamble, which recites an
"intended use" of the claimed composition because it describes what the
composition is to be used for, namely, "for enhancing the antioxidant status
of an animal." The "terms appearing in a [claim] preamble may be deemed
limitations of a claim when they give meaning to the claim and properly
define the invention." In re Paulsen, 30 F.3d 1475, 1479 (Fed. Cir. 1994).
"Conversely, 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. Dror, 112
F.3d 473, 478 (Fed. Cir. 1997). However, the preamble is regarded as
limiting if it recites essential structure that is important to the invention or
necessary to give meaning to the claim. NTP, Inc. v. Research In Motion,
Ltd., 418 F.3d 1282, 1305---06 (Fed. Cir. 2005), cert. denied, --- U.S.----,
126 S.Ct. 1174 (2006).
In this case, the body of the claim recites four different ingredients -
methionine, taurine, vitamin C, and vitamin E - each in specific amounts.
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Application 12/296,148
The term "antioxidant status" is defined in the Specification as "the balance
between pro-oxidants and the antioxidant system." Spec. i-f 3. A
composition with the recited components is said to achieve this purpose. Id.
at i-f 10. Appellants have not explained how the claim preamble that the
composition is "for enhancing the antioxidant status of an animal" would
provide additional structure or meaning to the claim. When the four
ingredients are administered to an animal, they enhance the antioxidant
status of the animal as a property of the composition having these
components in the recited amounts. Consequently, the claim preamble is not
sufficient to distinguish the claimed subject matter from a composition have
the same, overlapping, or obvious therefrom, amounts of the four anti-
oxidants. We decline to give the claim preamble "patentable" weight.
Zicker describes the same antioxidants recited in the claims.
Appellants have not distinguished the claimed subject matter from Zicker on
this basis. Thus, Zicker is an appropriate starting point for the obviousness
analysis because its composition has the same components recited in the
claims. While Zicker does not characterize the composition as being for
enhancing antioxidant status, it explicitly characterizes its components as
antioxidants which would therefore enhance the antioxidant status of the
animal. Appellants have not identified any feature of the claim that is added
by the recitation of "for enhancing the antioxidant status."
Douglass
The Examiner cited Douglass for its teaching of amounts of taurine
that fall within the scope of the claim.
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Zicker teaches that "the sulfur-containing amino acids or antioxidants
in the methods and compositions of the present invention can include one or
more sulfur-containing amino acid selected from the group consisting of
cysteine, methionine, taurine ... " Zicker ,-r 7.
Zicker describes a test and control formula with 0.2161 wt% and
0.1946 wt% taurine (id. at ,-r 28), respectively, which corresponds to 2161
and 1946 ppm.
Douglass teaches dry cat food diet containing 550, 750, 950, and 1400
mg/kg dry matter of taurine (Douglass S 180, (Table 2)) which corresponds
to the same values in ppm.
Douglass teaches that "[a]t both 4 and 10 wk, the relationship between
whole blood taurine concentration and dietary taurine was linear for the first
three levels of each diet type but seemed to plateau above 950 mg/kg DM
for the dry." Id.
Appellants contend that there would have been no reason to reduce
the levels of taurine in the Zicker's food composition, based on Douglass,
because Zicker observed an increase in animal activity as compared to the
control when the amount of taurine was 2161 ppm. Appeal Br. 7.
This argument is not supported by the evidence. Zicker feeds a test
and control formula to cats. The test formula increased activity, but the
control did not. Zicker ,-r 27. The amounts of each of the four ingredients
differed in the test versus the control formula, i.e., taurine (2161 v. 1946),
vitamin E (178 v. 114), vitamin C (175 v. <10), and methionine (1.29 v.
0.932). See Zicker, Table 2 (p. 11 ). In other words, because Zicker raised
the levels of all four anti-oxidants, it cannot be discerned which anti-oxidant
was responsible for the observed increase in the cat's activity. For this
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reason, the evidence does not support the conclusion that the taurine levels
enhanced the cat's activity.
Furthermore, Zicker does not restrict its composition to the amount of
taurine in the test food composition shown in Table 2 on page 10. Other
than the test formula, which has close to the same amount of taurine as in the
control (2161 v. 1946), Zicker does not provide guidance on the taurine
amounts in its diet composition. Consequently, the evidence does not point
to the single example in Zicker of taurine in the test formula as limiting or
defining its amounts, particularly, when these amounts are about the same as
in the control formula.
Appellants argue that a skilled worker would not have selected 1400
ppm of taurine, rather than 950ppm of taurine, in view of Douglass'
teachings.
Indeed, while Douglass indicates that cats fed diets containing
1400 mg/kg DM of taurine had a higher concentration of
taurine plasma after ten \veeks (e.g., 103 µmol/L)[,] the
concentration in whole blood was not actually higher than cats
fed dry diets containing 950 mg/kg, at the ten week time point.
Additionally, the fact that cats fed dry diets containing 1400
mg/kg also finished the study with the higher taurine plasma
concentration may be a bit misleading given that the cohort had
a higher initial plasma level oftaurine (e.g., 127 µmol/L) than
the cohort fed the 950 mg/kg diet (e.g., 108 µmol/L) (See,
Douglass p. S 180, Table 2).
Appeal Br. 8.
This argument is not persuasive. With respect to the plasma levels,
the 550 mg/kg taurine cohort went from 134 to 53 µmol/L plasma taurine at
the end of the ten week period, while the 1400 mg/kg taurine cohort went
from 127 to 103 µmol/L plasma taurine. Thus, while both cohorts started
out about the same (134, 127), the cohort fed 1400 mg/kg taurine had almost
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Application 12/296,148
twice the plasma levels at the end of ten weeks (53, 103). Thus, there was a
clear benefit to increasing the taurine levels in the diet to 1400 mg/kg.
While it is true that the cohort fed 950 mg/kg taurine started out with plasma
levels lower than the other two cohorts, going from 108 µmol/L plasma
taurine to 70 at week ten, it does not negate the fact that cats fed 1400 mg/kg
had increased plasma levels over 550 mg/kg cohort. Furthermore, we note
that the decline in plasma taurine levels in the 950 mg/kg group was 38 (108
- 70) while the decline in the 1400 mg/kg group was only 24 (127 - 103).
Consequently, Appellants' argument about there being no additional benefit
to increasing the taurine amount above 950 mg/kg is not supported by a
preponderance of evidence.
Appellants argue that "the Douglass reference even confirms that
there is little benefit to using taurine concentrations over 950 mg/kg in dry
diets" (Appeal Br. 8). However, the actual recommendation in Douglass is
of" 1000" (Douglass, S 180) and it mentions a published recommended value
of "1000-1200" (id. at SI 79). Thus, the reason to select these values, as
found by the Examiner, is that they are the recommended values of taurine
for a companion animal. While the amounts of 1000 and 1000-1200 do not
precisely overlap with the claimed range of 1200-1400, they "are so close
that prima facie one skilled in the art would have expected them to have the
same properties," shifting the burden to the applicant to show they are
different. Titanium Metals Corp. v. Banner, 778 F.2d 775, 783 (Fed. Cir.
1985).
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Application 12/296,148
Heaton
Heaton was also cited by the Examiner for its teaching of providing
taurine to animals as an antioxidant. Heaton 8. The Examiner calculated the
amounts of taurine described in Heaton to be 800, 1200 and 1500 ppm in dry
pet foot. Final Rej. 6. Appellants did not identify an error in this finding.
Zicker administers taurine as an antioxidant. Zicker i-f 7. One of
ordinary skill in the art would therefore have reasonably looked to Heaton
for guidance on how much taurine to administer to an animal because
Heaton teaches it for the same purpose. The amounts described in Heaton,
namely 800, 1200, 1500 ppm, and higher, overlap, with claimed range of
1200-1400. Final Rej. 6. When there is a range disclosed in the prior art,
and the claimed invention overlaps or falls within that range, there is a
presumption of obviousness. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir.
2003); Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed.
Cir. 2004). Heaton even discloses larger taurine values (Final Rej. 6; Heaton
8:25 to 9:2) that include the amounts in Zicker's test and control formula,
adding credence to the finding that Zicker' s taurine values would not have
been viewed as limiting by one of ordinary skill in the art. In sum, a
preponderance of the evidence supports the Examiner's determination that
the claimed range would have been obvious based on Heaton.
Unpredictability
Appellants contend that the results shown in Tables 1 and 2 of the
Specification would not have been predicted by one of ordinary skill in the
art. Appeal Br. 4. Appellants state of the four foods in Table 1 - A, B, C,
and D- only Food 4 "provides a decidedly shorter DNA tail than the other
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Application 12/296,148
diets in the comet assay in Example 1," indicative of the least amount of
oxidative damage to the DNA. Id.
Tables 1 and 3 are reproduced below. Table 1 has been annotated to
show whether the antioxidant falls within the scope of claims 13 and 21
("Y") or not ("N").
Table I
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! :Pl:ms:phorus: (~\'i) tL-61 j (bSS l 0.93 . U4
l''-'r au~1~;~ f Ol;~;;)""""-~------------- ... A ......... 14Q(}"'"Y'"t"····--·'ifrifo'""I(·-· ..............