Ex Parte Cazemier

Patent Trial and Appeal Board

Nov 9, 2017

12863325 (P.T.A.B. Nov. 9, 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.
12/863,325 08/23/2010 Anne Cazemier P107.12-0003 5395
27367 7590 11/14/2017
WESTMAN CHAMPLIN & KOEHLER, P.A.
SUITE 1400
900 SECOND AVENUE SOUTH
MINNEAPOLIS, MN 55402
EXAMINER
SOROUSH, LAYLA
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
11/14/2017 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):
docketing @ wck.com
tsorbel@wck.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANNE CAZEMIER
Appeal 2017-004042
Application 12/863,3251
Technology Center 1600
Before ULRIKE W. JENKS, ELIZABETH A. LaVIER, and
JOHN E. SCHNEIDER, Administrative Patent Judges.
LaVIER, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant seeks review of the
Examiner’s rejections of claims 8, 12, and 15—17. We have jurisdiction
under 35 U.S.C. § 6(b). For the reasons set forth below, we AFFIRM.
BACKGROUND
The Specification seeks to provide “a non-antibiotic method and
composition for animal feed that will help to treat or prevent intestinal
infections caused by gram-positive bacteria in animals.” Spec. 17.
1 Appellant states the real party in interest is Purac Biochem BY. Br. 3.
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Application 12/863,325
Claim 8 is illustrative:
8. A method for treating intestinal infections caused by
gram-positive bacteria in animals selected from cattle or poultry
comprising feeding the animal with an effective amount of an
antimicrobial compound selected from lactylate in accordance
with formula 1,
Formula 1: R2-COO- [-CH (CH3) -COO]n-Rl or a Na, K,
Ca, Mg, Fe(II), Zn, NH4, or Cu(II) salt thereof,
a glycolylate of formula 2,
Formula 2: R2-COO- [-CH2-COO]n-Rl or aNa, K, Ca,
Mg, Fe(II), Zn, NH4, or Cu(II) salt thereof
a lactate ester of formula 3,
Formula 3: HO-CH (CH3) -COO-R2
or a glycolic acid ester of formula 4,
Formula 4: HO-CH2-COO-R2
wherein in the above formulae R1 is H, n stands for an
integer with a value of 1—10, and R2 stands for a C1-C35 alkyl
or alkenyl chain which may be branched or unbranched.
Br. 21 (Claims Appendix).
REJECTIONS MAINTAINED ON APPEAL
1. Claims 8 and 15—17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Scholz,2 McCaffrey,3 and Gloxhuber.4 Ans. 3.
2 Scholz et al., US 2006/0051384 Al, published Mar. 9, 2006.
3 McCaffrey et al., US 5,663,155, issued Sept. 2, 1997.
4 Gloxhuber et al., Anionic Surfactants: Biochemistry, Toxicology,
Dermatology (2d ed. 1992).
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Application 12/863,325
2. Claim 12 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Scholz, McCaffrey, Gloxhuber, and Tagg.5 Ans. 5.
3. Claims 8 and 15—17 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Scholz, McCaffrey, Gloxhuber, and Dahms.6
Ans. 5.
4. Claim 12 stands rejected under 35 U.S.C. § 103(a) as
unpatentable over Scholz, McCaffrey, Gloxhuber, Dahms, and Tagg.
Ans. 7.
5. Claims 8, 12, and 15—17 stand provisionally rejected under the
ground of non-statutory double patenting, as unpatentable over claims
1—10 of Application No. 14/390,877.7 Ans. 9.
DISCUSSION
The Examiner finds that Scholz teaches a compound within the scope
of claim 8, i.e., lauroyl lactylate, as an antiseptic useful for treating mucosal
membranes of mammals. Final Action 5 (citing Scholz || 50, 83).8 As
Scholz “fails to specify feeding the animal lauroyl lactylate” {id.), the
Examiner turns to other references. McCaffrey teaches compositions for
preventing or treating parasitic infections in animals, and that administering
5 Tagg et al., Bacteriocins of Gram-Positive Bacteria, 40 Bacteriological
Revs. 722-755 (1976).
6 Dahms et al., US 5,911,981, issued June 15, 1999.
7 We note that this application recently issued (on Aug. 8, 2017) as US
9,723,860 B2.
8 We refer to the Office Action dated Nov. 27, 2015, which the Examiner
indicates is final. See Final Action 1.
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Application 12/863,325
such compositions orally, when possible, “may often be the most effective
method” for treating infections caused by gastrointestinal parasites. Id. at 5—
6 (citing McCaffrey 12:64—13:1, 13:48—50). The Examiner further cites
Gloxhuber “solely [] to show sodium lauroyl lactylate orally administered to
rats” (id.) and Dahms for teaching that lauroyl lactylate “is used in the food
industry, and [is] considered very safe” (id. at 8 (citing Dahms 14:58—63)).
Tagg, applied only to the rejections of claim 12, and “is solely used to show
that Clostridium is a gram-positive bacteria.” Id. at 7.
A. Rejection 1
As to Scholz, Appellant attempts to distinguish this reference from the
claims by arguing that Scholz largely teaches: topical, not oral
administration; human subjects, not animals; and treatment of non-intestinal
bacterial infections. See Br. 14—15.9 Thus Appellant concludes that
Scholz’s “implicit disclosure” is “that lauroyl lactylate should be employed
in topical compositions - such as creams, balms and lotions - for application
to the skin.” Id. at 15. These arguments are not persuasive, as the prior art
must be considered for all of its teachings, including non-preferred
9 Appellant’s related assertion that Scholz “arguably” does not enable use of
lauroyl lactylate as an antiseptic, because there is no example in Scholz of
using a compound of Formula 1 as an antiseptic (Br. 15), is also not
persuasive. During prosecution, the appellant bears the burden of showing a
prior art reference is not enabled once the Examiner has established a prima
facie case. See In re Antor Media Corp., 689 F.3d 1282, 1288—89 (Fed. Cir.
2012) (referring to a § 102 rejection). Merely pointing out the absence of a
working example is not sufficient evidence of non-enablement. Moreover,
“a non-enabling reference may qualify as prior art for the purpose of
determining obviousness under § 103.” Symbol Techs., Inc. v. Opticon, Inc.,
935 F.2d 1569, 1578 (Fed. Cir. 1991) (citations omitted).
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Application 12/863,325
embodiments. See Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807
(Fed. Cir. 1989) (citation omitted). As the Examiner points out, Scholz
broadly contemplates treatment of various mammals, including cattle, and
expressly includes “gastrointestinal” among the mucous membranes targeted
for treatment. Final Action 5 (citing Scholz || 45, 50, 83); see also Ans.
12—13. Further, the Examiner finds that “Scholz teaches treatment of
bacteria, including gram positive bacteria (i.e. Staphylococcus aureus,
Staphylococcus epidermidis),” and that S. aureus can cause intestinal
infections. Ans. 13. As the Examiner correctly points out, “the prior art’s
mere disclosure of more than one alternative does not constitute a teaching
away from any of these alternatives.” Id.
Appellant asserts that McCaffrey is not analogous art because
McCaffrey relates to a different class of compositions (adenosine derivative,
deaminase inhibitor) and concerns treatment of parasitic infections caused
by eukaryotic organisms, not bacteria, which are prokaryotes. Br. 10—12.
Accordingly, Appellant maintains that “it would not have been obvious to
one of ordinary skill in the art to apply teachings related to eukaryotic
organisms with teachings related to prokaryotic organisms with any
expectation of success” (Br. 10), and that the rejection is the product of
improper hindsight {id. at 11). Here Appellant draws the scope of analogous
art too narrowly, and offers no logical or evidentiary support for its assertion
that “the inventor would not have looked to [McCaffrey’s] disclosure in
inventing a treatment for bacteria” (Br. 13). Appellant’s reliance on Circuit
Check Inc. v. QXQInc., 795 F.3d 1331 (Fed. Cir. 2015), is misguided. The
Circuit Check court opined that “[e]ven though an inventor may be aware of
rock carvings, it is not surprising that the inventor would not have looked to
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Application 12/863,325
rock carvings to improve the process of painting small dots on interface
plates for expensive circuit board testers.” Id. at 1336. The gap between
treatment regimens for different kinds of infections pales in comparison to
the chasm between the art of rock carving and electronic circuit boards, as
the set of potential routes of administration described in McCaffrey is the
same whether the infectious agent is eukaryotic or prokaryotic. We thus
discern no error in the Examiner’s reliance on McCaffrey. Further, as the
Examiner points out, McCaffrey “was used for the teaching of the regimen,”
not for treatment of prokaryotes. Ans. 10. Accordingly, McCaffrey is
“reasonably pertinent to the particular problem the inventor is trying to
solve,” Circuit Check, 795 F.3d at 1335, that is, to a method for treating or
preventing intestinal infections in mammals.
As to Gloxhuber, Appellant asserts that the data on the lethal dose in
rats of orally-administered lauroyl lactylate do not inform whether the
compound “is to be used orally to achieve a prophylactic or antibiotic effect
at concentrations below the lethal dose.” Br. 13. Be this as it may, the
Examiner relies on Gloxhuber merely to show that sodium lauryl lactylate is
safe for ingestion (see Ans. 12), which it does. Appellant also maintains that
“[o]ne of ordinary skill in the art may consider that the toxicity data from
tests carried out in rats and mice could be used for predicting toxic effects in
humans, however the claims preclude humans from their scope, being
concerned only with cattle or poultry.” Br. 14. To the extent that Appellant
is arguing that the rat data of Gloxhuber would not have been considered
relevant to one of ordinary skill in the art in seeking treatments for cattle or
poultry, Appellant provides no explanation or evidence in support. This
argument, as well as Appellant’s statement that clinical efficacy “can only
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Application 12/863,325
be inferred from a full complement of toxicity tests” {id. at 13), is not
persuasive because “[ojbviousness does not require absolute predictability,”
but rather “[o]nly a reasonable expectation that the beneficial result will be
achieved,” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986).
In sum, and contrary to Appellant’s suggestion (see Br. 13) that the
rejection is the product of impermissible hindsight, we agree with the
Examiner {see Final Action 6) that it would have been obvious from the
cited references to administer orally sodium lauroyl lactylate to treat
gastrointestinal infections, with the motivation to do so provided by
McCaffrey’s discussion of the advantages of oral administration to animals,
and Gloxhuber’s further disclosure that sodium lauroyl lactylate can be
safely administered orally. Cf. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398,
421 (2007) (explaining that pursuing known options within technical grasp
of ordinarily skilled artisan is “likely the product not of innovation but of
ordinary skill and common sense”).
Having considered each of Appellant’s arguments, we are
unpersuaded of any error by the Examiner in rejecting claim 8. Claims 15—
17, which are not argued separately, fall with claim 8. See 37 C.F.R.
§ 41.37(c)(l)(iv). We affirm Rejection 1.
B. Rejection 2
In rejecting claim 12, which depends from claim 8 and further recites
“wherein the gram-positive bacterium is of the genus Clostridia” (Br. 22
(Claims Appendix)), the Examiner relies on Tagg only “to show that
Clostridium is a gram-positive bacteria.” Final Action 7.
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Appellant contends that “simply being aware that C. botulinum is
gram-positive fails to make the recitation of claim 12 obvious.” Br. 16. We
disagree. As noted above, “[ojbviousness does not require absolute
predictability.” Merck, 800 F.2d at 1097. Appellant does not explain why
these differences among genera of gram-positive bacteria are germane to
differences in antiseptic efficacy. Accordingly, we discern no error in the
Examiner’s reasoning (see Final Action 7; Ans. 14) that Scholz’s teaching of
treating gram-positive bacteria with lauroyl lactylate would have provided a
reasonable expectation of success in treating Clostridium based on the
disclosure in Tagg that C. botulinum is also gram positive.
Accordingly, we affirm Rejection 2.
C. Rejections 3 and 4
Rejections 3 and 4 largely mirror Rejections 1 and 2, respectively,
except that the Examiner additionally relies on Dahms to teach that sodium
lauroyl lactylate “is used in the food industry, and considered very safe,”
thus further supporting the rationale for using this compound in oral
treatments. Final Action 8 (citing Dahms 14:58—63); see also id. at 9.
Appellant argues that Dahms relates to cleaning compositions, such as
toothpastes, which are not meant to be ingested. See Br. 17. According to
Appellant, that sodium lauroyl lactylate “may be safe if ingested in small
portions or in combinations with other ingredients” does not teach or suggest
‘ feeding the animal with an effective amount of an antimicrobial compound
as claimed.” Id.', see also id. at 18 (referring back to Rejection 3 arguments
in arguing Rejection 4).
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Application 12/863,325
We are not persuaded. The Examiner explains that Dahms “teaches
foods contain sodium lauroyl lactylate and an alkyl polyglucose; therefore,
sodium lauroyl lactylate and an alkyl polyglucoses used in other
compositions (i.e. the dentifrice) is considered very safe.” Ans. 14—15. As
such, the Examiner finds, and we agree, that Dahms indicates that “the
components of the dentifrice that can cause poisoning, are not the very safe,
sodium lauroyl lactylate and alkyl polyglucoses.” Id. at 15.
Aside from this discussion of Dahms, Appellant’s arguments
regarding Rejections 3 and 4 refer back to those we have already discussed
with respect to Rejections 1 and 2. These arguments are equally
unpersuasive as applied to Rejections 3 and 4. Therefore, we affirm
Rejections 3 and 4.
D. Rejection 5
Appellant does not argue the provisional obviousness-type double
patenting rejection. Accordingly, we summarily affirm Rejection 5. See 37
C.F.R. § 41.37(c)(l)(iv); MPEP § 1205.02.
CONCLUSION
We affirm the rejections of claims 8, 12, and 15—17. No time period
for taking any subsequent action in connection with this appeal may be
extended under 37 C.F.R. § 1.136(a)(l)(iv).
AFFIRMED
9