Rakesh N. Chettier

Patent Trials and Appeals Board

Aug 19, 2019

15421186 - (R) (P.T.A.B. Aug. 19, 2019)

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.
15/421,186 01/31/2017 Rakesh N. Chettier CHT-008U 2859
52966 7590 08/19/2019
Schramm-Personal-ACT
Michael R. Schramm
350 West
2000 South
Perry, UT 84302
EXAMINER
LEAVITT, MARIA GOMEZ
ART UNIT PAPER NUMBER
1633
NOTIFICATION DATE DELIVERY MODE
08/19/2019 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):
mike@schrammpatent.com
mikeschramm@besstek.net
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte RAKESH N. CHETTIER
____________

Appeal 2018-004583
Application 15/421,1861
Technology Center 1600
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS,
RICHARD M. LEBOVITZ, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING
Appellant requests rehearing of the Decision entered July 26, 2019
(“Decision”) reversing the rejections under the written description and
enablement provisions of 35 U.S.C. § 112(a) and entering a New Ground of
Rejection under 35 U.S.C. § 112(b).
We DENY the requested relief.

1 Appellant identifies “Rakesh N. Chettier and Michael R. Schramm” as the
real party in interest (Appellant’s January 8, 2018 Appeal Brief (App. Br.)
2).
Appeal 2018-004583
Application 15/421,186

2
STATEMENT OF THE CASE
Appellant’s disclosure “relates to methods for use in preparing stem
cell [(SC)] compositions and for use in administering such compositions to
patients” (Spec. ¶ 2). Claim 1 is representative and reproduced below:
1. A treatment method comprising obtaining at least one SC
from a patient determined to have or be predisposed to at least
one genetic condition, identifying at least one marker associated
with an increased risk of said condition in said at least one SC,
editing the genetic sequence of said at least one SC via CRSP
such that at least one of the following is performed comprising
elimination of said condition increased risk associated marker
from said at least one SC and introduction of a condition
decreased risk associated marker to said at least one SC,
causing said at least one SC to initiate differentiation into a
predetermined tissue, administering said edited at least one SC
to said patient.
(App. Br. 32.)

Claim 1 stands rejected as indefinite under 35 U.S.C. § 112(b).
As the Decision explains, “although we exercised our discretional
authority under 37 C.F.R. § 41.50(b) to reject Appellant’s claim 1, we leave
it to Examiner to determine the appropriateness of any further rejections of
Appellant’s claimed subject matter. See Manual of Patenting Examining
Procedure § 1213.02” (Decision 8).

ANALYSIS
Appellant contends that “the Board committed reversible error . . .
[because] [t]he Board indicated that claim 1 was amenable to various
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Application 15/421,186

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interpretations when in fact claim 1 is not amenable to various
interpretations” (Req. Reh’g2 2). We are not persuaded.
We recognize Appellant’s contentions regarding a distinction between
autogenic and allogenic (see id. at 4 (“[A]ppellant respectfully urges that . . .
neither the instant specification teaches nor does claim 1 . . . claim either or
both of the allogeneic treatment of a genetic disease and the autogeneic
treatment of a genetic disease”); id. at 2 (“Appellant’s position is that claim
1 can only be interpreted consistent with an autogeneic administration of
stem cells (aka the . . . ‘second embodiment’ [set forth in Appellant’s
Specification])”); id. at 3 (“Appellant is neither advocating that claim 1
reads on the allogenic treatment of a genetic disease nor the autogeneic
treatment of a genetic disease (the specification and the claims –– especially
claim 1 –– do neither), but rather that the treatment was applied to the SCs
that are subsequently administered to a patient”); see id. at 5 (Appellant
contends “that it is inherently impossible to interpret claim 1 as anything
other than the patient from whom the at least on SC is obtained is the
selfsame patient to whom the at least on SC is administered, which of course
is the very definition of an autogenic administration of stem cells”)).
To be clear, the indefiniteness issue on this record does not concern
whether the SCs are from an allogenic or autogenic source. To the contrary,
the indefiniteness issue on this record is whether Appellant’s claim is limited
solely to a method of preparing a SC, or alternatively to both a method of
preparing a SC and treating a genetic disease in a patient with such a SC (see
Decision 6–7). See generally, In re Zletz, 893 F.2d 319, 322 (Fed. Cir.

2 Appellant’s August 7, 2019 Request for Rehearing.
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Application 15/421,186

4
1989) (“[D]uring patent prosecution when claims can be amended,
ambiguities should be recognized, scope and breadth of language explored,
and clarification imposed.”).
Appellant’s claim 1 recites a treatment method (Spec. ¶¶ 7–8; cf.
App. Br. 32)” (Decision 5). As the Decision explained, the second disclosed
embodiment of Appellant’s invention “describes a method of preparing a SC
composition and administering this composition to a patient” (Decision 4
(citing Spec. ¶ 8); see Req. Reh’g 2 “Appellant’s position is that claim 1 can
only be interpreted consistent with . . . the . . . ‘second embodiment’ [set
forth in Appellant’s Specification]”). This method recites that “a patient is
determined to be genetically predisposed to degenerative disk disease
(DDD) or to have clinical indications of DDD or both” (Decision 4 (citing
Spec. ¶ 8)). SCs are obtained from this patient and modified to, inter alia,
“no longer include a marker associated with the existence or predisposition
to DDD” (id.). These SCs are then “caused to initiate differentiation into the
tissue of choice, namely disk tissue, and . . . [are] then administered to the
patient via injection into at least one disk of the patient . . . [to] stimulate
regeneration of disk material that is not predisposed to DDD” (id. at
Decision 4–5).
Thus, although there is no doubt that Appellant is preparing SCs,
Appellant’s Specification discloses that these SCs are taken from a patient
genetically predisposed to DDD or having clinical indications of DDD,
modified, and reintroduced into the same patient to stimulate regeneration of
disk material that is not predisposed to DDD. Thus, a patient with a genetic
disease, i.e. DDD, is treated by this method. Appellant’s enumerated
contentions in the Rehearing Request only serve to support that the claims
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Application 15/421,186

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may be read in two different ways, and do not clearly support one claim
interpretation over the other.
For the foregoing reasons, we are not persuaded by Appellant’s
intimation that the Board did not understand or misinterpreted the term
“treatment” (see Req. Reh’g 2–4). Therefore, we are not persuaded by
Appellant’s contention that “contrary to the Board’s erroneous assertion
there are ‘no two ways’ to interpret claim 1 and therefore claim 1 is not
indefinite” (Req. Reh’g 5). Appellant has not convinced us that there are not
two possible interpretations of claim 1, and therefore we agree with our
original determination that claim 1 is indefinite.
The rejection of claim 1 under 35 U.S.C. § 112(b) is maintained.
Appellant’s requested relief is denied (see Req. Reh’g 6).
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).

REHEARING DENIED