Ex Parte Czarnecki-Maulden et al

Patent Trial and Appeal Board

Mar 21, 2017

12225649 (P.T.A.B. Mar. 21, 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.
12/225,649 08/20/2010 Gail Czarnecki-Maulden NO 8116/US/PCT 9845
69099 7590 03/23/2017
Nestle Purina Petcare Global Resources, Inc
Checkerboard Square
Intellectual Property Patents
ST. LOUIS, MO 63164
EXAMINER
HENRY, MICHAEL C
ART UNIT PAPER NUMBER
1673
NOTIFICATION DATE DELIVERY MODE
03/23/2017 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):
purinapatentmail@purina.nestle.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GAIL CZARNECKI-MAULDEN, IVAN FILIPI, and
CHRISTOPH CAVADINI1
Appeal 2016-004726
Application 12/225,649
Technology Center 1600
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
SMITH, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a dietary
supplement. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 According to Appellants, the real party in interest is Nestec, S.A. (Appeal
Br. 3.)
Appeal 2016-004726
Application 12/225,649
STATEMENT OF THE CASE
Claims on Appeal
Claims 1, 2, 4—7, 9—11, 31, and 32 are on appeal. (Claims Appendix,
Appeal Br. 24—26.) Claims 1 and 4 are illustrative and read as follows:
1. A dietary supplement comprising at least one
microencapsulated probiotic and at least one of animal digest,
dried brewer's yeast, vitamin C, vitamin E, beta carotene, zinc
proteinate, manganese proteinate, ferrous sulfate, copper
proteinate, calcium iodate, and sodium selenite, wherein said
dietary supplement is capable of sustaining substantial viability
of said microencapsulated probiotic at one or more elevated
temperatures comprising a temperature from 45°C to 65°C.
4. The dietary supplement of claim 1 wherein the probiotic
comprises Enterococcus faecium strain SF68, wherein the
substantial viability of said microencapsulated probiotic is
maintained at least about 90% when stored for a period of 11
days at temperatures up to 50°C, 2 days at the temperatures up to
60°C, or 20 hours at temperatures up to 65°C.
(Id. at 24.)
Examiner’s Rejections
1. Claims 1, 2, 4, 5, 9—11, 31, and 32 stand rejected under 35 U.S.C.
§ 103(a) as unpatentable over Hamilton2 and Cavadini.3 (Ans. 2—5.)
2. Claims 1,2, and 6 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Hamilton and Malnoe.4 (Id. at 5—7.)
3. Claim 9 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
Hamilton, Malnoe, and Seaborne.5 (Id. at 7—8.)
4. Claim 7 stands rejected under 35 U.S.C. § 103(a) as unpatentable over
2 Hamilton, US 2003/0060503 Al, published Mar. 27, 2003 (“Hamilton”).
3 Cavadini et al., US 5,968,569, issued Oct. 19, 1999 (“Cavadini”).
4 Malnoe et al., US 2005/0100617 Al, published May 12, 2005 (“Malnoe”).
5 Seaborne et al., US 4,820,533, issued Apr. 11, 1989 (“Seaborne”).
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Application 12/225,649
Hamilton, Cavadini, and Shushunov.6 (Id. at 8—9.)
FINDINGS OF FACT
We adopt as our own the Examiner’s findings regarding the scope and
content of the prior art, and reasons to combine the cited references. The
following findings are included for emphasis and reference purposes.
FF 1. The Specification states “[mjicrocapsules comprise an active agent,
e.g., a probiotic core surrounded by a biocompatible shell or coating.
Suitable materials for preparation of biocompatible microcapsules and
methods for encapsulation are known in the art. . . .” (Spec. 148.)
FF 2. The Examiner finds that Hamilton teaches nutritional supplements for
pets, including compositions that include (for example) vitamin E, zinc
proteinate, manganese proteinate, and dried brewer’s yeast. (Ans. 3, citing
Hamilton || 42, 43, and 46.)
FF 3. The Examiner finds that Cavadini teaches a probiotic that can be used
in a pet food or composition. (Ans. 3, citing Cavadini Abstract and claims.)
FF 4. Cavadini teaches that “the probiotic micro-organism may be
encapsulated to further increase the probability of survival.” (Cavadini col.
3,11. 30-32.)
FF 5. The Examiner finds that
it is obvious to expect that the composition or dietary supplement
to be capable of sustaining the viability of the microencapsulated
probiotic at different temperatures since [Cavadini] disclose[s]
that the probiotic micro-organism may be encapsulated to further
increase the probability of survival of said probiotic micro­
organism, and thus to determine factors such as the probability
of survival or viability of said microencapsulated probiotic at
6 Shushunov, US 2003/0143293 Al, published July 31, 2003 (“Shushunov”).
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Application 12/225,649
different temperatures such as temperatures for storing the
composition and heating the composition before serving to pets.
(Ans. 4.)
FF 6. The Examiner finds that one of ordinary skill in the art would have
been motivated, in view of Hamilton and Cavadini, to prepare a composition
comprising a combination of the claimed compounds to treat, feed, or
provide a nutritional supplement to a pet, and to further add a
microencapsulated probiotic to the composition “because [Cavadini] teaches
that probiotic micro-organisms added to pet food beneficially affects the
host by improving its intestinal microbial balance and that encapsulation
further increases the probability of survival of the probiotics.” {Id. at 4—5.)
FF 7. The Examiner finds that Malnoe teaches that pet food prebiotics and
probiotics can be incorporated into pet food as desired. (Ans. 6, citing
Malnoe 1 60.)
FF 8. Malnoe teaches that “the probiotic micro-organism may be
encapsulated to further increase the probability of survival.” (Malnoe 162.)
FF 9. The Examiner finds that Seaborne discloses that shellac, in
combination with a biopolymer, can be used to provide a moisture-barrier
coating on foods. (Ans. 7, citing Seaborne Abstract and col. 7,1. 59—col. 8,
1. 24.)
FF 10. The Examiner finds that Shushunov teaches that an anti-diarrhea
agent can be used in a composition to treat a mammal, such as a dog. (Ans.
8, citing Shushunov Abstract and 1 8.)
DISCUSSION
We agree with and adopt the Examiner’s findings, analysis, and
conclusions as set forth in the Final Action (Final Act. 2—21) and Answer
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Application 12/225,649
(Ans. 2—28). We discern no error in the Examiner’s rejections of the claims
on appeal as obvious. Appellants’ arguments are addressed below.
Issue
Whether a preponderance of evidence of record supports the
Examiner’s rejections under 35 U.S.C. § 103(a).
Analysis
Rejection No. 1
Claim 1
Appellants argue that the cited references “do not teach or suggest a
dietary supplement comprising a microencapsulated probiotic capable of
withstanding such elevated temperatures” as claimed. (Appeal Br. 13—14.)
Microencapsulation
Appellants argue that, while “Cavadini merely mentions the
possibility of encapsulating the probiotic microorganism,” Appellants’
invention utilizes “probiotics that are themselves microencapsulated.” (Id. at
14.) Moreover, according to Appellants, Cavadini teaches encapsulation of
probiotics “after the probiotics are incorporated into existing food. To be
clear, nothing in Cavadini suggests to individually microencapsulate the
probiotics as presently claimed.” (Id. at 16.)
We are not persuaded. As an initial matter, we agree with the
Examiner that Cavadini teaches “that the probiotic in the composition can be
itself encapsulated.” (Ans. 14; FF 4.) Furthermore, we agree with the
Examiner that Appellants’ composition “as claimed does not exclude a
composition that is encapsulated or that is in an encapsulated form.” (Ans.
14.) Appellants’ effort to distinguish “encapsulation” from
“microencapsulation” is similarly unpersuasive. (See Reply Br. 6; Ans. 11—
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12.) Appellants use the term “encapsulation” in connection with the
preparation of microcapsules, and state that methods for such encapsulation
“are known in the art.” (FF 1.)
“[T]he [obviousness] analysis need not seek out precise teachings
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex Inc., 550
U.S. 398, 418 (2007). In light of Cavadini’s teaching that the probiotic can
be encapsulated and the fact that Appellants’ Specification concedes that
encapsulation methods were known in the art, we discern no error in the
Examiner’s reliance on Cavadini (or Malnoe) for teaching or suggesting
microencapsulated probiotics.
Elevated Temperatures
Appellants argue that “Appellants’ invention elucidates a dietary
formulation that enhances probiotic survival at much higher temperatures
than those taught in Cavadini.” (Appeal Br. 15.) In particular, Appellants
argue that “Cavadini discloses a probiotic/carrier substrate mixture
comprising a probiotic organism exhibiting viability at only 25 °C and 37
°C, rather than the elevated temperatures recited in Appellants’ claims.”
{Id.) Appellants also point to Table 5 of the Specification to argue that
“Appellants’ formulation unexpectedly provided for greater probiotic
survival, even at greatly elevated temperatures.”7 {Id. at 15—16.)
7 Appellants describe Table 5 as reflecting viability of microencapsulated E.
faecium in excess of 90% after one week at 45 °C, 50 °C, and 55 °C, and
nearly 90% viability after 2 days at 60 °C. (Appeal Br. 15; Spec. 170.)
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We are not persuaded. As the Examiner finds, one would expect
Cavadini’s probiotic8 that is “encapsulated to further increase the probability
of survival” would be capable of sustaining viability at different
temperatures. (FF 4, 5.) The Examiner also points to Pollmann9 as
disclosing a microencapsulated preparation of probiotic E.faecium SF68,
and Exhibit B10 as showing that microencapsulated E.faecium SF68
provides viability for the shelf life of the product and through the GI tract of
dogs and cats, thereby “further showing] that microencapsulation or
encapsulation of probiotics such as microencapsulation of E. faecium
increases the probability of survival (viability) of the probiotics as taught by
Cavadini.” (Ans. 19; Pollman 4347; Exhibit B 10.) See In re Spada, 911
F.2d 705, 708 (Fed. Cir. 1990) (“Products of identical chemical composition
can not have mutually exclusive properties.”).
The Examiner also points out that the examples referred to in
Cavadini do not include an encapsulated probiotic. (Ans. 17; see also
Appeal Br. 20: “Malnoe, much like Cavadini, merely presents a prophetic
example of encapsulated probiotics.”) As such, Appellants’ comparison to
Cavadini’s examples is inapt. Moreover, the argument that Appellants have
shown “unexpected results” over Cavadini is similarly unpersuasive, at least
because it is merely argument without evidence and because it does not
8 Cavadini lists a number of examples of probiotic microorganisms,
including E.faecium. (See Cavadini col. 3,11. 12—27.)
9 Pollmann et al., Effects of a Probiotic Strain of Enterococcus faecium on
the Rate of Natural Chlamydia Infection in Swine, Infection and Immunity
73 (7), 4346-53 (2005) (“Pollmann”).
10 The Role of Probiotics in GI Tract Health, Purina Veterinary Diets®
monograph (2006) (“Exhibit B”).
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Application 12/225,649
reflect a comparison to encapsulated probiotics. See In re De Blauwe, 736
F.2d 699, 705 (Fed. Cir. 1984) (holding that “[m]ere argument or conclusory
statements in the specification does not suffice” to establish unexpected
results, and that results must be shown to be unexpected compared “to the
closest prior art”).
For the reasons of record, and as set forth above, we affirm the
rejection of claim 1.
Claim 4
Appellants argue that dependent claim 4 “recites a specific
microencapsulated probiotic . . . and a specific viability profile,” and argue
further “that such elements are not taught by the cited references and that the
present data provides unexpected results.” (Appeal Br. 16—17.) Appellants
argue further that claim 4 is directed to a heat range, that “protection against
heat is wholly missing from the cited references as well as the specific heat
ranges presently recited,” and that, as previously discussed, “the present
microencapsulation provides unexpected results over the viability found in
Cavadini.” (Id. at 17.)
We are not persuaded. The Examiner’s findings regarding the
specific probiotic (E.faecium SF68) and viability at different temperatures,
as well as the deficiencies in Appellants’ unexpected results contention, are
addressed above in connection with claim 1. Moreover, while specific
temperatures are not expressly discussed in connection with Cavadini’s
encapsulated probiotic, viability of the probiotic/carrier substrate mixture at
certain temperatures (e.g., 25°C and 37°C) are addressed by Cavadini, with
the added teaching that encapsulation would “further increase the probability
of survival.” (See Appeal Br. 15; FF 4.) Accordingly, for the reasons of
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record and these reasons, and the reasons set forth above in connection with
claim 1, we affirm the rejection of claim 4.
Claims 31 and 32
Claim 31 is dependent on claim 1 and recites essentially the same
temperature/viability profile recited in claim 4, and claim 32 is dependent on
claim 31 and recites that the substantial viability is “at least about 90%,”
again similar to claim 4. (Appeal Br. 25—26.) Appellants essentially repeat
the same arguments as advanced in connection with claims 1 and 4, and they
are unpersuasive for the reasons set forth above. (Id. at 18—20.)
Accordingly, for the reasons of record and the reasons set forth above in
connection with claims 1 and 4, the rejection of claims 31 and 32 is
affirmed.
Rejection No. 2
Appellants argue that “Malnoe, much like Cavadini, merely presents a
prophetic example of encapsulated probiotics,” and otherwise advance
essentially the same arguments as addressed above. (Appeal Br. 20-21.)
Accordingly, for the reasons of record and as set forth above, we affirm the
rejection of claim 1 as obvious over Hamilton and Malnoe. Claims 2 and 6
were not separately argued and fall with claim 1.
Rejection No. 3
Claim 9 is dependent on claim 1 and recites that “the microcapsule
comprises a biopolymer matrix coated with shellac.” (Appeal Br. 25.)
Appellants repeat their arguments advanced in connection with the rejection
of claim 1 and argue further that “Seaborne does not cure this deficiency” in
Hamilton and Malnoe. (Id. at 21—22.) Accordingly, for the reasons of
record and as set forth above, we affirm the rejection of claim 9.
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Rejection No. 4
Claim 7 is dependent on claim 1 and recites the dietary supplement
“further comprising an anti-diarrhea agent.” (Appeal Br. 25.) Appellants
repeat their arguments advanced in connection with the rejection of claim 1
and argue further that “Shushunov does not cure this deficiency” in
Hamilton and Cavadini. {Id. at 22—23.) Accordingly, for the reasons of
record and as set forth above, we affirm the rejection of claim 7.
Conclusions of Law
Rejection No. 1: A preponderance of evidence of record supports the
Examiner’s rejection of claims 1, 4, 31, and 32 under 35 U.S.C. § 103(a).
Claims 2,5, and 9—11 were not argued separately and fall with claim 1.
Rejection No. 2: A preponderance of evidence of record supports the
Examiner’s rejection of claim 1 under 35 U.S.C. § 103(a). Claims 2 and 6
were not argued separately and fall with claim 1.
Rejection No. 3: A preponderance of evidence of record supports the
Examiner’s rejection of claim 9 under 35 U.S.C. § 103(a).
Rejection No. 4: A preponderance of evidence of record supports the
Examiner’s rejection of claim 7 under 35 U.S.C. § 103(a).
SUMMARY
We affirm the rejections of all claims on appeal.
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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