Ex Parte Wedekind et al

Patent Trial and Appeal Board

Apr 13, 2017

12300539 (P.T.A.B. Apr. 13, 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.
12/300,539 06/23/2009 Karen Joy Wedekind 7601-00-HL 1058
23909 7590 04/17/2017
COLGATE-PALMOLIVE COMPANY
909 RIVER ROAD
PISCATAWAY, NJ 08855
EXAMINER
SOROUSH, ALI
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
04/17/2017 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,
TIMOTHY ARTHUR ALLEN, DALE ALLEN FRITSCH, and
CHADWICK EVERETT DODD
Appeal 2016-002662
Application 12/300,539
Technology Center 1600
Before JEFFREY N. FREDMAN, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal1 under 35U.S.C. § 134 involving claims to a method
and composition for treating or delaying chronic renal failure in a feline with
hyperthyroidism. The Examiner rejected the claims as obvious and on the
grounds of obviousness-type double patenting. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.
1 Appellants identify the Real Party in Interest as Hill’s Pet Nutrition, Inc.
(see App. Br. 2).
Appeal 2016-002662
Application 12/300,539
Statement of the Case
Background
“Both hyperthyroidism and CRF (also known as chronic renal disease
or renal insufficiency) are common diseases, particularly in older cats”
(Spec. 12). The Specification teaches “a composition for preventing CRF in
a feline with hyperthyroidism that may be susceptible to develop renal
insufficiency. Such a feline is one that has not been diagnosed with CRF,
but is at risk to develop CRF due to, for example, advanced age, genetic
predisposition, or disease(s) or medication(s)” (Spec. 114).
The Claims
Claims 1—11, 14—26 and 29-52 are on appeal. Claims 1 and 34 are
representative and read as follows:
1. A method for delaying progression to chronic renal
failure in a feline with hyperthyroidism and in need of said
preventing, the method comprising feeding the feline a
composition comprising:
from about 28 to about 35% protein on a dry matter basis
wherein the protein comprises at least about 75% vegetable
protein: and
from about 0.1 to less than about 1 mg/kg iodine on a dry
matter basis and/or from about 0.1 to about 1 mg/kg selenium
on a dry matter basis:
wherein said feline is diagnosed with a loss of renal
reserve capacity, and wherein said delaying comprises slowing
progression of loss of said feline’s kidneys’ reserve capacity
and delaying the onset of chronic renal failure.
34. A composition for delaying progression to chronic renal
failure in a feline with hyperthyroidism and in need [sic] said
delay, the composition comprising:
from about 28 to about 35% protein on a dry matter basis
wherein the protein comprises at least about 75% vegetable
protein;
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Application 12/300,539
from about 0.1 to less than about 1 mg/kg iodine on a dry
matter basis and/or from about 0.1 to about 1 mg/kg selenium
on a dry matter basis; and
at least one additional component selected from the
group consisting of about 0.6 to about 0.8% phosphorus, about
0.25 to about 0.35% sodium, about 0.75 to about 1% potassium,
and combinations thereof.
The issues
A. The Examiner rejected claims 34—39, 41—48, and 50-52 under 35
U.S.C. § 103(a) as obvious over Wedekind2 and Young3 (Final Act. 3—4).
B. The Examiner rejected claims 40 and 49 under 35 U.S.C. § 103(a) as
obvious over Wedekind, Kobayashi,4 and Markwell5 (Final Act. 5—6).
C. The Examiner rejected claims 17—20, 32, and 33 under 35 U.S.C.
§ 103(a) as obvious over Wedekind and Adams6 (Final Act. 6—7).
D. The Examiner rejected claims 1—5, 15—20, 32, and 33 under 35 U.S.C.
§ 103(a) as obvious over Wedekind, Adams, and Brenner7 (Final Act. 7—9).
E. The Examiner rejected claims 6, 10, 11, 14, 21, 25, 26, and 29—31
under 35 U.S.C. § 103(a) as obvious over Wedekind, Adams, Brenner, and
Behrend8 (Final Act. 9—10).
2 Wedekind et al., WO 2004/112499 Al, published Dec. 29, 2004.
3 Young, H., US 3,203,806, issued Aug. 31, 1965.
4 Kobayashi et al., Hypertension in cats with chronic renal failure or
hyperthyroidism, 4 J. Vet. Intern. Med. 58—62 (1990) (abstract only).
5 Markwell, P., Dietary Management of Renal Failure in the Dog and Cat, 8
Waltham Focus 16-22 (1998).
6 Adams et al., Investigation of the Effects of Hyperthyroidism on Renal
Function in the Cat, 61 Can. J. Vet. Res. 53—56 (1997).
7 Brenner et al., The Interrelationships Among Filtration Surface Area,
Blood Pressure, and Chronic Renal Disease, 19 J. Cardiovasc.
Pharmacol. SI—7 (1992).
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F. The Examiner rejected claims 7, 9, 22, and 24 under 35 U.S.C.
§ 103(a) as obvious over Wedekind, Adams, Brenner, and Young (Final Act.
10-11).
G. The Examiner rejected claims 8 and 23 under 35 U.S.C. § 103(a) as
obvious over Wedekind, Adams, Brenner, Kobayashi, and Markwell (Final
Act. 12-13).
H. The Examiner rejected claims 34—38, 42, and 44-47 on the ground of
obviousness-type double patenting over claims 30-32, 39, 40, 42, 43, and 45
of copending US 12/162,4528 9 (Final Act. 16—17).
A. 35 U.S.C. § 103(a) over Wedekind and Young
The Examiner finds Wedekind teaches “a preparation of a dry cat
food composition comprising - 5% animal protein, 30-35% vegetable
protein, 0.2 mg/kg of selenium and 0.2mg/kg of iodine on a dry matter basis
(paragraph 0035). The composition was [fed] to geriatric cats with
hyperthyroid disease for eight weeks” (Final Act. 4).
The Examiner acknowledges Wedekind does not expressly teach
further including 0.6 to 0.8% phosphorous and 0.75 to 1 % potassium in the
composition (see Final Act. 4). The Examiner finds Young teaches “pet
food composition which comprises 0.8% phosphorous and 0.8% potassium
of dry weight composition” (Id.).
8 Behrend, E., Medical Therapy of Feline Hyperthyroidism, 21 Compendium
on Continuing Educ. for the Practicing Veterinarian 234-44 (1999).
9 This application matured into US 8,993,001, issued Mar. 31, 2015,
rendering the rejection non-provisional (see MPEP § 804(I)(B)(2)).
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The Examiner finds it obvious “to add potassium and phosphorous to
the diet of Wedekind ... in order provide additional minerals for the
nutrition of the feline” (Final Act. 4).
The issue with respect to this rejection is: Does the evidence of record
support the Examiner’s conclusion that Wedekind and Young render claim
34 obvious?
Findings of Fact
1. Wedekind teaches “dietary maintenance of the healthy feline
and, more particularly, to methods for reducing risk of developing
hyperthyroidism in a feline by restricting the amount of selenium intake in
the feline” (Wedekind 11).
2. Wedekind teaches:
A low selenium, low iodine dry cat food, designated diet 30643,
was prepared with the following composition and
characteristics: grain ingredients, 50-55%; animal protein, 0-
5%; vegetable protein, 30-35%; animal fat, 8-10%; other
ingredients, 5-7%; selenium, 0.2 mg/kg on a dry matter basis;
and iodine, 0.2 mg/kg on a dry matter basis.
(Wedekind 135).
3. Young teaches that minimum phosphorus amounts in wet, dry,
and semidry pet foods are 0.3, 0.8, and 0.6%, respectively (see Young 3:18).
Principles of Law
A preamble is not limiting “‘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.”’ Catalina Mktg. Int 7, Inc. v.
Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002).
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“The combination of familiar elements according to known methods
is likely to be obvious when it does no more than yield predictable results.”
KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Analysis
We adopt the Examiner’s findings regarding the scope and content of
the prior art (Final Act. 3^4; FF 1—3) and agree that the claimed composition
would have been obvious over the teachings of Wedekind and Young. We
address Appellants arguments below.
Appellants contend “claims 34 and 44 are directed to compositions for
delaying progression of and treating chronic renal failure in a hyperthyroid
feline in need of such delay” and that “the two populations of felines, i.e., all
hyperthyroid cats as compared to that subset of hyperthyroid cats that are in
need of delaying progress of chronic renal failure, are not the same” (App.
Br. 4).
We find this argument unpersuasive because the preamble phrase “for
delaying progression to chronic renal failure in a feline with
hyperthyroidism” represents an intended use of the composition. “It is well
settled that the recitation of a new intended use for an old product does not
make a claim to that old product patentable.” In re Schreiber, 128 F.3d
1473, 1477 (Fed. Cir. 1997). In this case, the composition rendered obvious
by Wedekind and Young renders obvious the structurally complete
composition recited in the body of claim 34 (FF 1—3) for the reasons given
by the Examiner (see Final Act. 4).
Appellants contend “the Examiner has impermissibly relied on a form
of hindsight reasoning by using Applicants’ invention to define the problem
that the invention solves” (App. Br. 4). Appellants contend
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When the actual problem faced by Applicants is properly
phrased, it becomes perfectly clear that there was no reason to
start with Wedekind which discloses a myriad of compositions
for treating a separate and distinct condition (hyperthyroidism)
and then select the very one that is closest to that recited in
Applicants’ claims and use that composition for a purpose
never appreciated nor contemplated by Wedekind.
(App. Br. 5).
We are not persuaded. While we are fully aware that hindsight bias
may plague determinations of obviousness, Graham v. John Deere Co., 383
U.S. 1,36 (1966), we are also mindful that the Supreme Court has clearly
stated that the “combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR, 550 U.S. at 416.
In the instant case, we agree with the Examiner that inclusion of the
mineral phosphorus into pet food as taught by Young into the Wedekind’s
pet food designed for hyperthyroid cats would have been obvious “in order
provide additional minerals for the nutrition of the feline” (Final Act. 4).
Consistent with the Examiner’s position (see Ans. 14), simply because the
prior art has a different reason or motivation to combine the components of
Wedekind and Young than Appellants is of no moment as long as there is a
sufficient reason to make the combination. See In re Kemps, 97 F.3d 1427,
1430 (Fed. Cir. 1996) (“[T]he motivation in the prior art to combine the
references does not have to be identical to that of the applicant to establish
obviousness.”).
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Wedekind and Young render claim 34 obvious.
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B. 35 U.S.C. § 103(a) over Wedekind, Kobayashi, and Markwell
Appellants do not separately argue this obviousness rejection, instead
relying upon their arguments to overcome Wedekind and Young (see App.
Br. 5). The Examiner provides sound fact-based reasoning for combining
Kobayashi and Markwell with Wedekind (see Final Act. 5—6). Having
affirmed the obviousness rejection of claim 34 over Wedekind and Young
for the reasons given above, we also find that the further obvious
combination of Wedekind with Kobayashi and Markwell renders the
rejected claims obvious for the reasons given by the Examiner.
C. and D. 35 U.S.C. § 103(a) over Wedekind and Adams and Brenner
The Examiner finds Wedekind teaches a cat food composition as
discussed above for “geriatric cats with hyperthyroid disease” but does not
teach administration “to a cat suffering from chronic renal failure” (Final
Act. 7). The Examiner finds Adams teaches “hyperthyroidism and chronic
renal failure are common in older cats, some geriatric cats may have both
diseases concurrently” (Id.).
The Examiner finds the claims obvious because
there are geriatric cats that concurrently have hyperthyroidism
and chronic renal failure for the treatment of hyperthyroidism.
Since, the prior art composition is administered to the same
patient population and is structurally indistinguishable from
instant claims, the treatment of chronic renal failure would be
an inherent property of the method steps.
(Id).
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Wedekind and Adams
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inherently render obvious “delaying progression to chronic renal failure in a
feline with hyperthyroidism” or “treating chronic renal failure in a feline
with hyperthyroidism” as required by claims 1 and 17?
Findings of Fact
4. Adams teaches “[s]ince both hyperthyroidism and chronic
progressive polyuric renal failure/insufficiency are common in older cats,
some geriatric cats may have both diseases concurrently” (Adams 53, col.
2).
5. Adams teaches “cats with concurrent hyperthyroidism and
chronic renal insufficiency/failure” (Adams 53, col. 2).
Principles of Law
While a new and nonobvious method of using an existing (or obvious)
composition may itself be patentable, see Perricone v. Medicis Pharm.
Corp., 432 F.3d 1368, 1378 (Fed. Cir. 2005), “[w]e have recognized that
inherency may supply a missing claim limitation in an obviousness
analysis.” PAR Pharmaceutical, Inc. v. TWIPharmaceuticals, Inc., 773
F.3d 1186, 1194—95 (Fed. Cir. 2014). “[0]ur early precedent, and that of
our predecessor court, established that the concept of inherency must be
limited when applied to obviousness, and is present only when the limitation
at issue is the “natural result” of the combination of prior art elements.” Id.
at 1195.
Analysis
Appellants contend
Wedekind does not teach or suggest treating chronic renal failure in a
feline diagnosed with a loss of renal reserve capacity. The treatment
of hyperthyroidism cannot be construed as or deemed to be equivalent
to Applicants’ claimed treatment of chronic renal failure since not
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only can renal failure develop in non hyperthyroid felines, but also
hyperthyroidism does not necessarily and inevitably lead to renal
failure.
(App. Br. 5—6; cf App. Br. 6).
The Examiner responds “in the subset of cats diagnosed with both
hyperthyroidism and chronic renal failure the administration of the
composition of Wedekind et al. would inherently treat chronic renal failure
at the same time as it would treat hyperthyroidism” (Ans. 15).
We find the Examiner has the better position. While we agree with
Appellants that Adams does not establish every cat has both conditions,
Adams clearly states “both hyperthyroidism and chronic progressive
polyuric renal failure/insufficiency are common in older cats” (FF 4),
supporting the Examiner’s reasoning that treatment of hyperthyroidism as
taught by Wedekind will necessarily treat some cats in need of treatment for
chronic renal failure. Consistent with Par Pharmaceuticals, this treatment
of the subset of cats with both conditions is the natural result of treating
geriatric cats with hyperthyroidism with the pet food of Wedekind. Par
Pharmaceuticals, 773 F.3d at 1195.
We recognize, but find unpersuasive, Appellants’ contention that “the
Examiner has impermissibly relied on a form of hindsight reasoning” (App.
Br. 6; cf. App. Br. 7) because even if the prior art has a different reason or
motivation to treat cats based on the teachings of Wedekind and Adams,
there need only be sufficient reason to make the combination. See Kemps,
97 F.3d at 1430.
Conclusion of Law
The evidence of record supports the Examiner’s conclusion that
Wedekind and Adams inherently render obvious “delaying progression to
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chronic renal failure in a feline with hyperthyroidism” or “treating chronic
renal failure in a feline with hyperthyroidism” as required by claims 1 and
17.
E.-G. 35 U.S.C. § 103(a)
Appellants do not separately argue these obviousness rejections,
instead relying upon their arguments to overcome Wedekind and Adams
(see App. Br. 7). The Examiner provides sound fact-based reasoning for
combining Behrend, Young, Kobayashi and Markwell with Wedekind and
Adams (see Final Act. 9-13). Having affirmed the obviousness rejection of
claims 1 and 17 over Wedekind and Adams for the reasons given above, we
also find that the further obvious combinations with Behrend, Young,
Kobayashi and Markwell render the rejected claims obvious for the reasons
given by the Examiner.
H. Obviousness-type Double Patenting
Appellants present no arguments for reversing the obviousness-type
double patenting rejection. Therefore, we summarily affirm this rejection.
See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“When the
appellant fails to contest a ground of rejection to the Board ... the Board
may treat any argument with respect to that ground of rejection as waived.”)
SUMMARY
In summary, we affirm the obviousness and obviousness-type double
patenting rejections.
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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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