Zelton Dave. Sharp et al.

Patent Trials and Appeals Board

Apr 30, 2020

15337410 - (D) (P.T.A.B. Apr. 30, 2020)

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.
15/337,410 10/28/2016 Zelton Dave SHARP UTSK.P0431USC1/1000337183 1088
32425 7590 04/30/2020
NORTON ROSE FULBRIGHT US LLP
98 SAN JACINTO BOULEVARD
SUITE 1100
AUSTIN, TX 78701-4255
EXAMINER
AZPURU, CARLOS A
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
04/30/2020 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):
aoipdocket@nortonrosefulbright.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ZELTON DAVE SHARP, RANDY STRONG, PAUL HASTY,
CAROLINA LIVI, and ARLAN RICHARDSON

Appeal 2018-007738
Application 15/337,410
Technology Center 1600
____________

Before DONALD E. ADAMS, ERIC B. GRIMES, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge.

DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from Examiner’s
decision to reject claims as anticipated and lacking enablement. We have
jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42(a). Appellant identifies the real party in interest as “The Board
of Regents of The University of Texas System, and the licensees, the
National Institutes of Health, U.S. Department of Health and Human
Services, U.S. Government NIH Division of Extramural Inventions and
Technology Resources.” Br. 1.
Appeal 2018-007738
Application 15/337,410
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STATEMENT OF THE CASE
“The invention relates to methods and compositions[, for example
rapamycin,] for treating or preventing intestinal adenomas or polyps or
preventing cancer in a patient who has been identified as being at risk for
developing intestinal polyps or intestinal cancer.” Spec. ¶ 3. “Familial
adenomatous polyposis (FAP) is an autosomal dominant disease caused by
mutation of the Adenomatous Polyposis Coli (APC) gene . . . . This
germline defect accelerates the initiation of the adenoma-carcinoma,
resulting in the development of numerous adenomatous colorectal polyps at
a young age.” Spec. ¶ 47.
Claims 1–3, 12, 14–26, and 29–31 are on appeal, and can be found in
the Claims Appendix of the Appeal Brief. Claim 1 is representative of the
claims on appeal, and reads as follows:
1. A method for extending the lifespan expectancy in a
patient genetically susceptible to or diagnosed with familial
adenomatous polyposis (FAP), the method comprising
administering an effective amount of a composition comprising
rapamycin to the patient wherein the life span is extended to
equal to or greater than the lifespan of a patient not genetically
susceptible to or diagnosed with familial adenomatous
polyposis.
Br. 7 (Claims Appendix).
REFERENCE
The prior art relied upon by Examiner is:
Name Reference Date
Sharp et al. (“Sharp”) US 2012/0064143 A1 Mar. 15, 2012

Appeal 2018-007738
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REJECTIONS
Appellant requests review of the following grounds of rejection made
by Examiner:
I. Claims 1–3, 12, 14–26, and 29–31 under 35 U.S.C. § 112, first
paragraph for lacking enablement.
II. Claims 1–3, 12, 14–26, and 29–31 under 35 U.S.C. § 102(b) as
anticipated by Sharp.
DECISION
I. Enablement
Examiner finds that the claims fail to comply with the enablement
requirement. See Final Act.2 3–5.
In response, Appellant directs attention to paragraphs 119–120 of the
Specification. See Br. 4–5. Appellant contends that “the current disclosure
provides an in vivo working example of a demonstration of the claimed
methods using an art-recognized [mouse] model for FAP,” and therefore the
claims are enabled. Id. 5.
Examiner acknowledges that the Specification provides “examples
showing the claimed rapamycin composition in extending the lifespan of a
patient genetically susceptible to or diagnosed with familial adenomatous
polyposis intestinal polyposis (FAP) in mice.” Final Act. 4. Examiner takes
issue with the claim limitation of extending the lifespan of the patient “to
equal to or greater than the lifespan of a patient not genetically susceptible to
or diagnosed with familial adenomatous polyposis,” as recited in claim 1.
See generally Ans. 3–4.

2 Final Office Action mailed November 14, 2017 (“Final Act.”).
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Application 15/337,410
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The Specification recites “that eRapa treatment beginning early in life
in ApcMin/+ mice prevents polyps from developing and progressing to the
bleeding stage thereby resulting in a life span equal to and perhaps greater
than wild type, normal mice.” Spec. ¶ 120 (emphasis added).
On this record, we find that Examiner has the better position. As
Examiner explains, the phrase
equal to and perhaps greater than wild type . . . is more
troublesome because it says that an extension of life span may
occur (or may not), and there is no definitive statement as to
this increase. . . . [T]his statement points to situations where the
life span is either not increased at all, or may or may not be
increased even in the art recognized mouse model.
Ans. 4. We agree with Examiner that the relied upon paragraphs in the
Specification are not sufficiently compelling to establish the claimed
“greater” increase in life expectancy with the claimed treatment.
Accordingly, we affirm the enablement rejection for the reasons set
out by Examiner in the Final Office Action and Answer.

II. Anticipation
Examiner finds that Sharp teaches a method of preventing intestinal
cancer by administering an effective amount of rapamycin. See Final Act. 5–
6 (citing Sharp ¶¶ 17–19, 21, 25–28, 105, 106, 113, 116, 121–123, and 126–
128); see Ans. 4–5. Here, Examiner finds that the present claims are
“treating FAP using the same method, using the same compounds, and
administered in the same manner in a therapeutically effective amount to
treat the same condition as disclosed by Sharp.” Ans. 5.

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Application 15/337,410
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Appellant contends that the prosecution history of Sharp establishes
that Sharp does not enable Appellant’s claimed invention and, therefore,
Sharp does not anticipate Appellant’s claimed invention. Br. 5–6 (citing
Appendix A).
We are not persuaded. During the prosecution of Sharp, Examiner
rejected Sharp’s claims under the written description provision of 35 U.S.C.
§ 112, first paragraph, finding that Sharp’s
claims have been amended to claim a “method for extending
lifespan expectancy in a mammalian”. While there is support
for prolonging the lifespan of a mammalian subject, the
originally filed specification does not appear to provide
adequate support for a method of “extending lifespan
expectancy” in a mammal. Furthermore, the new limitation
“wherein the life expectancy of the mammalian subject is
extended to at least the mean expected lifespan or to at least the
age of life expectancy of a subject without adenomas of the
colon or without a genetic predisposition to adenomas of the
colon” is not supported by the originally filed specification. The
specification as filed does not provide adequate support for
prolonging the lifespan as claimed in reference to a mammal
without colon adenoma or a genetic predisposition to colon
adenoma.
See Br., Appendix A 3 (emphasis added); cf. Br. 5–6. Sharp’s prosecution
history, however, further reveals that Examiner subsequently dropped the
foregoing rejection in favor of a new rejection, necessitated by amendment,
under 35 U.S.C. § 112, second paragraph, finding indefinite Sharp’s claim
limitation “wherein the lifespan is extended to greater than the life
expectancy of the mammalian subject.” Sharp Final Act.3 3–4. This
indefiniteness rejection was subsequently affirmed on Appeal. See Appeal

3 Final Office Action in Application No. 13/128,800 mailed July 13, 2017.
Appeal 2018-007738
Application 15/337,410
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2018–008436, Application 13/128,800, Decision 3–6 (Sharp’s “claim
language does not make clear what effect is required in order for a method
of administering rapamycin to fall within the scope of [Sharp’s] claim[s]”).
Thus, although Examiner may have initially questioned whether
Sharp’s disclosure provided adequate written descriptive support for its
claims, this question was resolved on Sharp’s record in favor of an
indefiniteness rejection.
Other than directing our attention to the written description rejection
discussed above entered into and later withdrawn from Sharp’s prosecution
history, Appellant presents no further argument with regard to the rejection
under 35 U.S.C. §102(b) on this record. See Br. 5.
Because Appellant has not directed us to any error in Examiner’s
rejection, we affirm the anticipation rejection based on Sharp for the reasons
set out by Examiner in the Final Office Action and Answer.

Appeal 2018-007738
Application 15/337,410
7
DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1–3, 12,
14−26, 29–
31
112, first
paragraph
enablement 1–3, 12,
14−26, 29–
31

1–3, 12,
14−26, 29–
31
102(b) Sharp 1–3, 12,
14−26, 29–
31

Overall
Outcome
1–3, 12,
14−26, 29–
31

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)(1)(iv).

AFFIRMED