Ex Parte Zanghi

Patent Trial and Appeal Board

Jan 31, 2018

13991716 (P.T.A.B. Jan. 31, 2018)

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.
13/991,716 06/05/2013 Brian Michael Zanghi 10441-US-PCT 5493
69099 7590 02/02/2018
Nestle Purina Petcare Global Resources, Inc
Checkerboard Square
Intellectual Property Patents
ST. LOUIS, MO 63164
EXAMINER
HIRT, ERIN E
ART UNIT PAPER NUMBER
1616
NOTIFICATION DATE DELIVERY MODE
02/02/2018 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):
purinapatentmail@purina.nestle.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte BRIAN MICHAEL ZANGHI1
Appeal 2016-005988
Application 13/991,716
Technology Center 1600
Before ULRIKE W. JENKS, RICHARD J. SMITH, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a method for
promoting sleep in a companion animal. The Examiner entered final
rejections for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Background
The Specification discloses:
1 Appellant identifies the Real Party in Interest as Nestec, S.A. App. Br. 3.
Appeal 2016-005988
Application 13/991,716
Normal aging is accompanied by an increased prevalence in
sleep disturbances and decrease in sleep quality. As many as
80% of elderly subjects experience difficulty initiating sleep
and also show increased night-time wakefulness, early waking,
and/or increased daytime napping. Likewise, in dogs, aging has
been associated with changes in sleep patterns and declining
activity levels, as commonly reported by pet owners and
observed under controlled conditions.
Increased sleep disturbances or decreased sleep can have
deleterious effects, such as decreased cognitive performance
like reduced mental acuity and reduced memory, decreased
motor skills, and also increased health risks associated with
depression, cardiovascular disease, obesity, and/or diabetes.
. . . sleep aids for animals are generally non-existent. There is,
therefore, a need for a composition capable of promoting sleep
in animals.
Spec. 3-5.
The Specification discloses “methods and compositions useful for
promoting sleep and particularly to the use of astaxanthin and melatonin to
promote sleep in animals.” Spec. ^ 2.
Claims 1-6, 11, 12, 17-21, and 53-55 are on appeal. Claim 1 is
illustrative and reads as follows:
1. A method for promoting sleep in a companion animal
comprising administering in conjunction a sleep promoting
amount of astaxanthin and a sleep promoting amount of
melatonin to the companion animal, wherein the companion
animal is a dog or a cat, wherein the astaxanthin and the
melatonin are administered at a time in the afternoon, in the
evening, or before a typical bedtime of the companion
animal.
App. Br. 17 (Claims Appendix).
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Claim 19, the only other independent claim, recites that, rather than
melatonin, the composition comprises “one or more metabolizable
compounds that can be metabolized to produce melatonin to the companion
animal.” Id. at 18-19.
Appellant seeks our review of the Examiner’s rejection of claims 1-6,
11, 12, 17-21, and 53-55 under 35 U.S.C. § 103(a) as obvious over
Gordon,2 Honda,3 Young,4 Relaxi-Herb,5 and Canine Cushing’s.6 Final Act.
3.7
DISCUSSION
Issue
The Examiner finds that Gordon teaches “melatonin containing
supplements” for use in dogs and cats and “that it was known in the art that
melatonin calmed stressed, nervous or anxious pets and was useful as a sleep
2 US 2005/0249785 Al, pub. November 10, 2005 (“Gordon”).
3 US 2007/0128310 Al, pub. June 7, 2007 (“Honda”).
4 US 7,211,280 Bl, issued May 1, 2007 (“Young”).
5 “Only Natural Pet Relaxi-Herb Herbal Supplement for Dogs and Cats,”
(http://web.archive.org/web/20060810221257/http://www.onlynaturalpet.co
m/products/Only-Natural-Pet-Relaxi-Herb-Herbal-Formula/999020.aspx),
printed August 19, 2014 (“Relaxi-Herb”).
6 “Introduction and help with night time restlessness - Canine Cushing’s
Information and Support Forums,”
(http://www.k9cushings.com/forum/showthread.php?t=2623), printed
November 6, 2014. We note the Examiner stated “see entries by
HarleyPommom and Frijole and Casey’s Mom dated 10/20/2010) as is
evidenced by Drs. Foster and Smith
(http://web.archive.org/web/20090104215222/http://www.peteducation.com/
article.cfm?c=2+1659&aid=718 and
http://www.peteducation.com/article.cfm?c=l+1400&aid=717)” (“Canine
Cushing’s”). Final Act. 3.
7 Examiner’s Final Action, mailed May 6, 2015 (“Final Act.”).
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aid in pets.” Final Act. 4. The Examiner finds Gordon discloses melatonin
doses of “0.1 mg/kg to about 12 mg/kg.” Id.
The Examiner finds that Honda discloses “pet foods for dogs and cats
which contain astaxanthin and/or tryptophan (which is metabolizable to
melatonin), and which improves sleep.” Id. The Examiner finds Honda
discloses “the astaxanthin is administered in amounts of from about 0.1 to
about 60 mg/kg of bodyweight” and is given twice a day at feeding. Id. The
Examiner finds Gordon and Honda do not teach “wherein the composition
further comprises zinc in amounts of from 10 to about 100 mg/kg,” “do not
teach wherein their compositions are administered with additional sleep
aids/drugs, specifically holistic sleep aids,” and do not “teach wherein the
melatonin and/or astaxanthin is only/specifically administered at a time in
the afternoon or in the evening, or before a typical bedtime of the companion
animal.” Id. at 5-6.
The Examiner finds Young teaches “methods and compositions for
improving the condition and longevity of elderly pets” comprising “at least
2 mg-2.5mg/kg of zinc,” which the Examiner finds discloses the amounts
within the ranges of the claims at issue. Id. at 5.
The Examiner finds Relaxi-Herb “teaches holistic sleep aids/drugs for
dogs and cats which comprises herbal agents which are known to help with
sleep.” Id.
The Examiner finds that because the claims employ the term
“comprising,” they do not “exclude administering the composition more
than once a day, i.e. twice a day which would be in the morning and
evening.” Id. at 5-6. The Examiner further finds that Canine Cushing’s
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teaches “administering sleep aids, specifically melatonin, to dogs to help
them sleep in the evenings and/or just prior to bedtime.” Id. at 6.
The Examiner concludes that it would have been obvious to the
skilled artisan to have combined the compositions of Gordon and Honda,
and to have added zinc in the claimed amounts, and the
astaxanthin/melatonin/zinc composition with other sleep promoting
aids/drugs and/or holistic sleep aids “because all of these agents were known
in the art for treating sleep disorders and/or providing necessary nutrients to
dogs and cats for optimal health, especially senior dogs and cats, thereby
allowing the animal to get adequate sleep which is essential to good health.”
Id. The Examiner further finds the skilled artisan would have found
nighttime administration obvious for treating pets with sleep disorders based
on prior use of melatonin in the art for this purpose. Id. at 7.
The issue with respect to this rejection is: Does the evidence of
record support the Examiner’s conclusion that Gordon, Honda, Young,
Relaxi-Herb, and Canine Cushing’s suggest the claimed method of
promoting sleep in a companion animal?
Findings of Fact (FF)
1. Gordon discloses that “[mjost recently melatonin products have
emerged that tout the use for calming stressed, nervous or anxious
pets and as a sleep aid for pets.” Id. ^3.
2. Gordon discloses “a method of regulating or controlling shedding in
animals and a method of enhancing an animal’s hair coat by the
regular administration of an oral supplement containing small
amounts of melatonin.” Gordon Abstract. The “melatonin-containing
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oral supplement may be administered in the form of a pill, a tablet, a
capsule, a powder, a liquid or may be incorporated into food or food
pellets” and may be “administered to an animal at regular intervals.”
Id. The administered dose is “about 0.1 to about 12 mg per kg of
animal weight.” Id. at 2:5-7 (claim 2).
3. Honda discloses “pet food containing astaxanthin and/or an ester
thereof and having an effect of. . . improving sleep.” Honda ^ 1.
Honda discloses that “improving sleep . . . herein refers to an effect
for improving, treating, and suppressing a sleep disorder caused by
stress, disease, change in the rhythm of life, medication, physical
disorder, and aging.” Id. Tf 55.
4. Honda discloses that “pet food effective in improving sleep . . . may
be made of a composition constituted of tryptophan and a
carbohydrate . . . [or] a pharmaceutical composition containing a
novel melatonin derivative as an active ingredient.” Id. ^[8. The
composition was administered at feeding time (morning and night).
Id. H 69.
5. The Examiner concludes that Honda teaches administration of
astaxanthin “in amounts of from about 0.1 to about 60 mg/kg of
bodyweight (Examples 1 and 2).” Final Act. 4.
6. Young discloses a “method of increasing the quality of life of an
elderly pet” comprising administering to the pet “a nutritional
composition which contains . . . a zinc source.” Young 1:64-67. Zinc
is administered in amounts of “about 50 mg/1000 kcal to 500
mg/1000 kcal of zinc.” Id. at 3:24-25. Young also discloses that
“[pjreferably at least about 2 mg/kg body weight of zinc is
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administered” and discloses administration to dogs and cats. Id. at
6:26^13.
7. Relaxi-Herb discloses an “herbal formula designed for nervousness
and anxiety problems” composed of nine herbs, four of which are
stated to have potential or proven use in promoting sleep or relieving
insomnia. Relaxi-Herb 1.
8. Canine Cushing’s is an “Information and Support Forum[]” for
owners of pets having Cushing’s disease or similar symptoms.
Canine Cushing’s 1. Two owners, Harley PoMMom and frijole,
report having used melatonin to assist with calming or inducing sleep
in their pets. Canine Cushing’s 3,5.
Principles of Law
An invention is not patentable under 35 U.S.C. § 103 if it is obvious.
KSRIntI Co. v. Teleflex Inc., 550 U.S. 398, 427 (2007). Under § 103: the
scope and content of the prior art are to be determined; differences between
the prior art and the claims at issue are to be ascertained; and the level of
ordinary skill in the pertinent art resolved. Against this background, the
obviousness or nonobviousness of the subject matter is determined.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966). A central question in
analyzing obviousness is “whether the improvement is more than the
predictable use of prior art elements according to their established
functions.” KSR, 550 U.S. 417.
“One way for a patent applicant to rebut a prima facie case of
obviousness is to make a showing of ‘unexpected results,’ i.e., to show that
the claimed invention exhibits some superior property or advantage that a
person of ordinary skill in the relevant art would have found surprising or
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unexpected.” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). “Mere
improvement in properties does not always suffice to show unexpected
results. In our view, however, when an applicant demonstrates substantially
improved results . . . and states that the results were unexpected, this should
suffice to establish unexpected results in the absence of evidence to the
contrary.” Id. at 751.
Analysis
We adopt the Examiner’s findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 3-9; Ans. 2-8; FF 1-8) and
agree that the claims are rendered obvious by the combination of Gordon,
Honda, Young, Relaxi-Herb, and Canine Cushing’s.
Gordon teaches that melatonin is useful as a sleep aid for pets, and
may be administrated in multiple forms at regular intervals. FF1-2. Gordon
discloses administration of melatonin in the claimed amount. FF2. Honda
discloses a pet food used for improving sleep that contains astaxanthin and a
precursor of melatonin, in the claimed amounts, for use in feeding at
morning and night. FF4-6. Gordon and Honda do not teach administration
of zinc or herbal supplements for the purpose of sleep aid. However, Young
discloses a method for increasing the quality of life of an elderly pet by
administering zinc in the claimed amounts. FF6. Relaxi-Herb discloses that
herbal formulas may be used to promote sleep or insomnia in pets. FF7.
Canine Cushing’s also discloses that pet owners have administered
melatonin to their pets at night to assist the pet in sleeping better. FF8.
We agree with the Examiner that a skilled artisan would have had
reason to combine Gordon and Honda’s compositions to provide a sleep aid
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composition for pets with astaxanthin and either melatonin or a precursor of
melatonin because these references expressly disclose use of these
components as sleep aids in elderly pets. FF1—4; Final Act. 4-5. We further
agree with the Examiner that Canine Cushing’s reflects that it was known to
administer melatonin as a sleep aid for pets, including elderly pets, based on
the reports of pet owners’ success with this method. FF8; Final Act. 6.
We further agree that the skilled artisan would have had reason to add
zinc to the modified composition in the claimed amounts, because Young
discloses that nutrition sources with zinc in the claimed amounts increase the
quality of life of an elderly pet, and specifically, cats and dogs. FF6; Final
Act. 5. This is particularly the case because Young is also directed to
compositions for assisting with improving the quality of life of older pets,
and “[i]t is prima facie obvious to combine two compositions each of which
is taught by the prior art to be useful for the same purpose, in order to form a
third composition which is to be used for the very same purpose.” In re
Kerkhoven, 626 F.2d 846, 850 (CCPA 1980).
As discussed above, Gordon, Honda, and Young each teach that their
compositions assist with improving the sleep or relaxation of pets. FF1-6.
Moreover, with respect to the claim limitation “comprising administering in
conjunction a sleep promoting amount of astaxanthin and a sleep promoting
amount of melatonin [and, for dependent claim 4, “further comprising
administering in conjunction a sleep promoting amount of zinc”],” we also
find that the Examiner has sufficiently established that the claimed
compositions and the compositions rendered obvious by the prior art are
“substantially identicaf’ such that the burden is properly shifted to Appellant
to show that the prior art composition(s) would not “necessarily or
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inherently possess the characteristics of [the] claimed product,” i.e.,
improvement in promotion of sleep. In re Best, 562 F.2d 1252, 1255 (CCPA
1977) (citation omitted). We are thus not persuaded that the Examiner had
the burden to submit “results that melatonin provides a statistically
significant result as a sleep aid for pets, let alone Appellants’ claimed
composition” or that the “Appellants have provided unexpected results over
the closest cited reference.” (Reply Br. 6).
We further agree with the Examiner that the skilled artisan would
have found it obvious to add herbal supplements to the modified
composition based on Relaxi-Herb’s recognition of herbal supplements as a
sleep or relaxation aid. FF7; Final Act. 5. We also find that a skilled artisan
would have a reasonable expectation of success in combining Gordon,
Honda, Young, Relaxi-Herb, and Canine Cushing’s to arrive at the claimed
invention: Honda is a pet food of which the astaxanthin and melatonin (or
precursor of melatonin) are components, and Gordon, Young, Relaxi-Herb,
and Canine Cushing’s are each disclosed as “supplement” for administration
to an animal. FF1-8.
We have considered Appellant’s arguments but do not find them
persuasive.
Appellant argues that the rejection should be reversed because “the
present composition provides unexpected results over the prior art
composition . . . and that the time of administration provides an unexpected
benefit for the present formulation.” App. Br. 12. Appellant argues that the
Specification at paragraphs 73-84 discloses that “melatonin supplement
alone was not statistically different than the placebo, and both were far less
effective than the present formulation of melatonin, astaxanthin, and zinc.”
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Id. at 13. According to Appellant, “it was not known, nor could be predicted
from the art, that the present combination of melatonin and astaxanthin
would provide a dramatically improved effect over the teachings found in
the art.” Id. at 14. Appellant also argues that the timing recited in the
claims, ‘“at a time in the afternoon, in the evening, or before a typical
bedtime of the companion animal,’” is important because “PM
administration provides unexpected benefits over AM administration.” Id.
Appellant also argues that “none of the references actually show any results
that melatonin provides a statistically significant result as a sleep aid for
pets” or “recognizes that the administration time period is important to
effectiveness of the composition.” Id.
As an initial matter, we are not convinced that Appellant has
persuasively shown that the claimed combination demonstrates synergy.
“To be particularly probative, evidence of unexpected results must establish
that there is a difference between the results obtained and those of the closest
prior art, and that the difference would not have been expected by one of
ordinary skill in the art at the time of the invention.” Bristol-Myers Squibb
Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977 (Fed. Cir. 2014).
As the Examiner points out, “[AJppellants have never demonstrated
that their compositions provide results which are any better at improving
sleep than the additive increase that one of ordinary skill in the art would
expect when combining the 2 or 3 or 4 or 5 known sleep aid[s as] instantly
claimed for pets.” Ans. 3. We agree with the Examiner that Appellant’s
only result that appears to show a statistically significant increase, on the
sleep time of pets (Table 3) “uses a specific combination of astaxanthin,
melatonin and zinc,” and no data comparing the effect of zinc alone or
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astaxanthin alone were provided to permit our assessment of synergy. Ans.
4. Even if such results had been provided, “[sjynergism, in and of itself, is
not conclusive of unobviousness in that synergism might be expected.” In re
Kollman, 595 F.2d 48, 55 n.6 (CCPA 1979); see also In re Huellmantel, 324
F.2d 998, 1003 (CCPA 1963) (“[W]e attribute no magic status to synergism
per se since it may be expected or unexpected.”).
Appellant contends that the alleged synergism in the claimed
combination is unexpected (see, e.g., App. Br. 13, Reply Br. 5); however,
Appellant’s Specification does not state that the observed effect was
unexpected or surprising in any way, and unexpected results must be
established by factual evidence rather than mere attorney argument. In re
Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997).
Further, the sole evidence provided, for a specific combination of
astaxanthin, melatonin and zinc (Spec. ^ 74), is not commensurate in scope
with claim 1, which does not recite zinc as a component. In this regard, we
agree with the Examiner that “even if appellant’s ‘unexpected’ results are
determined to be ‘unexpected’ they still are not commensurate in scope with
the instant claims.” Ans. 4. To the extent that Appellant argues that at least
claim 4 should be allowed (Reply Br. 6), we are not persuaded because the
specific combination shown at paragraph 74 of the Specification does not
provide evidence supporting the entirety of claim 4, which does not specify
any amount of melatonin, astraxanthin, or zinc. In addition, as discussed
above, Appellant has not provided evidence to persuade us that the effect
claimed is not additive of the components in the composition.
We are similarly unpersuaded by Appellant’s argument that “the time
of administration provides an unexpected benefit for the present
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formulation” (App. Br. 12) as independent claims 1 and 19, which use the
transitional phrase “comprising,” do not restrict administration to a
nighttime dose. See Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501
(Fed. Cir. 1997) (“‘Comprising’ is a term of art used in claim language
which means that the named elements are essential, but other elements may
be added and still form a construct within the scope of the claim.”).
To the extent we understand Appellant’s argument that “incidental
teachings regarding human administration profiles for sleep aids would not
be inherently used with dogs” (App. Br. 15), we are not persuaded as the
prior art cited by the Examiner relates to administration to pets (FF1-8),
including the use of melatonin as a sleep aid in pets (Gordon, FF1).
Appellant further argues that the asserted prior art does not teach all of
the limitations of the claims. See, e.g., App. Br. 16. However, with one
exception, Appellant’s arguments in this regard do not identify any
limitation that is not taught by any of the references, but rather argue the
deficiencies of each reference as compared to the claimed composition and
that the references do not suggest the use of the disclosed components for
treating sleep disorders. See, e.g., App. Br. 13. These arguments are not
persuasive as the test for obviousness is what the combined teachings of
Gordon, Honda, Young, Relaxi-Herb, and Canine Cushing’s would have
suggested to one of ordinary skill in the art. See In re Keller, 642 F.2d 413,
425 (CCPA 1981) (citing cases).
The sole argument that identifies a limitation that is allegedly not
taught by any reference is Appellant’s contention that none of the prior art
references teaches the use of melatonin at night for administration of sleep.
See e.g., Reply Br. 7. As found by the Examiner (Ans. 5-6), and as
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discussed above, this argument is not persuasive because both independent
claims 1 and 19 use the transitional phrase “comprising” and therefore do
not limit administration to night only. And because Honda discloses
administration of sleep-inducing food by feeding at both morning and night,
a skilled artisan would have found it obvious to administer melatonin to an
animal at night. FF4.
Conclusion of Law
We affirm the Examiner’s rejection of claims 1, 4, and 19. Claims 2,
3, 5, 6, 11, 12, 17, 18, 20, 21, and 53-55 have not been argued separately
and therefore fall with claims 1, 4, and 19. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the Examiner’s rejection of claims 1-6, 11, 12, 17-21, and
53-55 under 35 U.S.C. § 103(a) as obvious over Gordon, Honda, Young,
Relaxi-Herb, and Canine Cushing’s.
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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