Ex Parte Sonnenburg et al

Patent Trial and Appeal Board

Nov 17, 2017

14046817 (P.T.A.B. Nov. 17, 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.
14/046,817 10/04/2013 Justin L. Sonnenburg STAN-987 1016
77974 7590 11/21/2017
Stanford University Office of Technology Licensing
Bozicevic, Field & Francis LLP
201 REDWOOD SHORES PARKWAY
SUITE 200
REDWOOD CITY, CA 94065
EXAMINER
PAGUIO FRISING, MICHELLE F
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
11/21/2017 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):
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JUSTIN L. SONNENBURG, JESSICA FERREYRA, and
KATHARINE NG1
Appeal 2017-003809
Application 14/046,817
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER,
and DAVID COTTA, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to
methods for reducing the growth of bacterial enteric pathogens which have
been rejected as anticipated and as obvious. We have jurisdiction under 35
U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as the Board of Trustees of
the Leland Stanford Junior University. Br. 1.
Appeal 2017-003809
Application 14/046,817
STATEMENT OF THE CASE
Oral antibiotic use is one of the leading risk factors for
disease associated with Salmonella spp. and Clostridium
difficile, consistent with increased enteric vulnerability upon
disruption of the resident microbiota. In addition, mouse
models of S. typhimurium or C. difficile infection commonly
require disruption of the intestinal microbiota with antibiotics to
promote pathogen expansion within the lumen of the gut (i.e.,
emergence) and to initiate disease.
Spec. 1 5.
The Specification describes a method for reducing the growth of
pathogenic bacteria by altering nutrient availability, specifically limiting the
availability of certain mucosal sugars. Spec. 1 8.
Claims 1,3, 6—9, 16—18, 23—26, and 282 are on appeal. Claims 1 and
28 are the sole independent claims and read as follows:
1. A method of reducing post-antibiotic growth of a
bacterial enteric pathogen in an individual, the method
comprising:
following antibiotic-induced disruption of the normal
microbiota in the individual;
administering a sialidase inhibitor active in the gut, in a
dose that is effective to reduce growth of an enteric bacterial
pathogen that lacks sialidase required for liberation of sialic
acid from gut mucosa.
28. A method of reducing post-antibiotic growth of C.
difficile or Salmonella typhimurium in an individual following
treatment with a broad spectrum antibiotic, the method
comprising:
2 In the Answer, the Examiner lists claims 1—11, 13—18, 20—26 and 29 as
rejected for anticipation. Ans. 9. Claims 2, 4, 5, 10-15, 19—22, 27, and 29
were canceled in an amendment filed Mar. 11, 2015.
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Application 14/046,817
administering a sialidase inhibitor active in the gut, in a
dose that is effective to reduce growth of C. difficile or
Salmonella typhimurium.
The claims stand rejected as follows:
Claims 1, 3, 7—9, 16—18, and 23—26 have been rejected under 35
U.S.C. § 102(b) as anticipated by Broadhurst.3
Claims 1, 3, 6—9, 16—18, 23—26, and 28 have been rejected under 35
U.S.C. § 103(a) as unpatentable over Broadhurst in view of Almagro-
Moreno.4
ANTICIPATION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that claims 1,3, 7—9, 16—
18, and 23—26 are anticipated by Broadhurst.
The Examiner finds that Broadhurst discloses methods for treating
diseases caused by neuraminidase-dependent bacteria by administering a
neuraminidase inhibitor5. Final Act. 5. The Examiner finds that Broadhurst
teaches that the administration of a neuraminidase inhibitor can occur after
the patient has been treated with antibiotics. Id. The Examiner finds that
Broadhurst teaches administration of neuraminidase inhibitors such as
3 Broadhurst, III, US 2006/0241063 Al, published Oct. 26, 2006
(“Broadhurst”).
4 Almagro-Moreno and Boyd, Bacteria catabolism of nonulosonis (sialic)
acid and fitness in the gut, 1 Gut Microbes 45 (2010) (“Almagro-Moreno”).
5 The claims refer to sialidase and the references refer to neuraminidase.
Compare claim 1 above, with Broadhurst 111. They are the same.
Broadhurst 127.
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oseltamivir and zanamivir to inhibit neuraminidase-dependent bacteria such
as E. coli and Salmonella. Id. The Examiner concludes that the method of
Broadhurst effectively performs the same steps as the claimed invention.
Final Act. 7.
Appellants contend that Broadhurst only teaches using a
neuraminidase inhibitor to control viruses and bacteria which can produce
sialidase. Br. 3. Appellants contend that Broadhurst does not teach using
the inhibitors to control pathogens which are incapable of producing
sialidase as required by the claims. Br. 4.
Principles of Law
“Anticipation requires that all of the claim elements and their
limitations are shown in a single prior art reference.” In re Skvorecz, 580
F.3d 1262, 1266 (Fed. Cir. 2009).
Analysis
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer regarding this rejection. We find the Examiner has established that
the claims are anticipated by Broadhurst. Appellants have not produced
evidence showing, or persuasively argued, that the Examiner’s
determinations on anticipation are incorrect. Only those arguments made by
Appellants in the Briefs have been considered in this Decision. Arguments
not presented in the Briefs are waived. See 37 C.F.R. § 41.37(c)(l)(iv)
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Application 14/046,817
(2015). We have identified claim 1 as representative; therefore, all claims
fall with claim l.6 We address Appellants’ arguments below.
Appellants contend that Broadhurst teaches the use of neuraminidase
inhibitors to control the growth of viruses and bacterial pathogens which
produce sialidase, whereas the present invention is directed to controlling the
growth of bacteria which do not produce sialidase. Br. 3. Appellants
contend that since Broadhurst does not teach limiting the growth of bacteria
which do not produce sialidase, Broadhurst does not anticipate the present
claims. Br. 4.
We find Appellants’ argument unpersuasive. Broadhurst teaches the
use of sialidase inhibitors to control infections by neuraminidase dependent
bacteria. Broadhurst 113. Broadhurst defines a neuraminidase-dependent
bacteria as one “known to use sialic acid (neuraminic acid) either as a source
for carbon, nitrogen, energy and amino acids for cell wall synthesis.”
Broadhurst | 54. Broadhurst also teaches that E. coli is a neuraminidase-
dependent bacteria. Broadhurst, Table 1. Hoyer,7 cited by the Examiner
(Final Act. 5), evidences that E. coli does not produce sialidase but does
metabolize sialic acid. Hoyer 873. We agree with the Examiner that
although Broadhurst does not specifically mention that the bacteria it
identifies do not produce sialidase, one skilled in the art would understand
6 While Appellant discussed claims 3, 7—9, 16—18 and 23—26, Appellant’s
argument for these claims is based on the novelty of claim 1, no separate
identification of novelty is provided for the dependent claims, and therefore
these dependent claims fall with claim 1. Br. 6—7.
7 Hoyer et al., Cloning, sequencing and distribution of the Salmonella
typhimurium LT2 sialidase gene, nanH, provides evidence for interspecies
gene transfer, 6 Mol. Microbiol. 873 (1992) (“Hoyer”).
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that the method taught by Broadhurst necessarily reduces the growth of such
organisms. Ans. 11—12. “Newly discovered results of known processes
directed to the same purpose are not patentable because such results are
inherent.” Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d
1368, 1376 (Fed. Cir. 2001). Moreover, “[wjhere, as here, the result is a
necessary consequence of what was deliberately intended, it is of no import
that the article’s authors did not appreciate the results.” MEHL/Biophile
Intern. Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999).
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claim 1 is anticipated by Broadhurst.
Claims 3, 7—9, 16—18, and 23—26 have not been argued separately and
therefore fall with claim 1. 37 C.F.R. § 41.37(c)(l)(iv).
OBVIOUSNESS
Issue
The issue with respect to this rejection is whether the rejected claims
would have been obvious over Broadhurst in view of Almagro-Moreno.
The Examiner finds that, for the reasons stated above, claims 1,3,7—
9, 16—18, and 23—26 are anticipated by Broadhurst. Final Act. 10. The
Examiner finds that while Broadhurst refers to treating infections caused by
Salmonella and Clostridium, Broadhurst does not mention the specific
species recited in claims 6 and 28. Final Act. 10. The Examiner finds that
Almagro-Moreno teaches that S. typhimurium uses sialic acid as a carbon
source via the action of the NanA enzyme. Almagro-Moreno 47. The
Examiner concludes that
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Since Broadhurst’s methods are intended for inhibiting
neuraminidase dependent bacteria, which is defined as “those
known to use sialic acid (neuraminic acid) either as a source for
carbon, nitrogen, energy and amino acids for cell wall
synthesis”, a person with ordinary skill in the art at the time of
invention would have recognized that S. typhimurium is an
applicable bacterial species to be inhibited in Broadhurst's
methods, in light of Almagro-Moreno et al. ’s teachings. It can
be expected that replacing Almagro-Moreno et al. ’s Salmonella
with S. typhimurium as the target of the disclosed method
would still lead to the neuraminidase inhibitor’s successful
inhibition of its growth after antibiotic treatment. Conclusion
of obviousness is supported by the rationale that substitution of
one known element of a known method for another, both
having equivalent effect, is considered to be obvious, absent a
showing that the result of the substitution yields more than
predictable results.
Ans. 10-11.
Appellants repeat the arguments regarding the teachings of Broadhurst
and argue that Almagro-Moreno does not cure the deficiencies of
Broadhurst. Br. 7. Appellants also argue that there is no motivation to
combine the references since C. difficile does not produce sialidase and
Broadhurst is limited to bacteria which produce sialidase. Br. 7—8.
Analysis
As discussed above, we agree with the Examiner’s conclusion that
claims 1,3, 7—9, 16—18 and 23—26 are anticipated by Broadhurst. It
necessarily follows that the claims are also obvious over Broadhurst. In re
Pearson, 494 F.2d 1399, 1402 (CCPA 1974) (Anticipation is the epitome of
obviousness).
With respect to the rejection of claims 6 and 28, we are unpersuaded
by Appellants’ argument that Almagro-Moreno does not address the
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deficiencies of Broadhurst. Br. 7. As discussed above, there are no
deficiencies in the teachings of Broadhurst.
Finally, we are unpersuaded by Appellants’ contention that there is
not motivation to combined Broadhurst and Almagro-Moreno. Br. 7—8. As
discussed above, Broadhurst addresses the use of neuraminidase inhibitors to
control the growth of bacteria which can metabolize neuraminic acid as well
as those that produce neuraminidase. Almagro-Moreno teaches that S.
typhimurium metabolized sialic acid. Almagro-Moreno, Table 1. Thus S.
typhimurium is a neuraminidase-dependent bacteria as defined in
Broadhurst. Broadhurst | 54. We agree with the Examiner that it would
have been obvious to one skilled in the art to use the method of Broadhurst
to minimize the growth of S. typhimurium. Ans. 13.
Conclusion of Law
We conclude that a preponderance of the evidence supports the
Examiner’s conclusion that claims 1, 3, 6-9, 16—18, 23—26, and 28 would
have been obvious over Broadhurst combined with Almagro-Moreno.
SUMMARY
We affirm the rejection under 35 U.S.C. § 102(b).
We affirm the rejection under 35 U.S.C. § 103(a).
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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