Rakesh N. Chettier

Patent Trials and Appeals Board

Jul 26, 2019

15421186 - (D) (P.T.A.B. Jul. 26, 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 07/26/2019
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
07/26/2019 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 APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1–22 (App. Br.
2). Examiner entered rejections under the written description and
enablement provisions of 35 U.S.C. § 112(a). We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE and enter a New Ground of Rejection.

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.)

Grounds of rejection before this Panel for review:
Claims 1–22 stand rejected under the written description and
enablement provisions of 35 U.S.C. § 112(a).

New Ground of Rejection:
Claim 1 is rejected as indefinite under 35 U.S.C. § 112(b).
ANALYSIS
Appellant discloses that “[s]tem cells (SC) or compositions containing
SCs . . . are known in the art . . . as are various methods of using such SCs,
to treat a variety [of] conditions including genetic and non-genetic
conditions in humans” (Spec. ¶ 3). In addition, Appellant discloses that
Appeal 2018-004583
Application 15/421,186

3
“[m]ethods of editing genes and in particular, a gene editing method entitled
the CRISPR Cas System (CRSP) is also known in the art” (id.).
Appellant discloses:
A first embodiment of the invention is a method of preparing an
SC composition and administering the SC composition to a
patient. The method preferably includes the following steps. A
quantity of SCs is obtained from a donor. The SCs are
genetically screen (e.g. genetically sequenced and analyzed).
At least one marker associated with the existence or
predisposition to at least one genetic condition is identified.
The genetic sequence of the SCs is altered such that the SCs no
longer include a marker associated with the existence or
predisposition to at least one genetic condition. The SCs are
administered to a patient.
(Spec. ¶ 7 (emphasis added).) Thus, the first embodiment of Appellant’s
invention, describes a method of preparing a SC composition and
administering this composition to a patient, wherein:
(a) [a] quantity of SCs is obtained from a donor,
(b) [t]he SCs are genetically screen[ed],
(c) [a]t least one marker associated with the existence or
predisposition to at least one genetic condition is identified [in
the SCs],
(d) the SCs [are] altered such that the SCs no longer
include a marker associated with the existence or predisposition
to at least one genetic condition, [and]
(e) [t]he SCs are administered to a patient.
(See id. (lettering and emphasis added).)
Appellant further discloses:
A second embodiment of the invention is a method of preparing
an SC composition and administering the SC composition to a
patient. The method preferably includes the following steps. A
patient is determined to be genetically predisposed to
degenerative disk disease (DDD) or to have clinical indications
Appeal 2018-004583
Application 15/421,186

4
of DDD or both. A quantity of SCs is obtained from the
patient. The SCs are genetically screen (e.g. genetically
sequenced and analyzed). At least one marker associated with
the existence or predisposition to DDD (AKA an increased risk
or so-called “causative” marker) is identified. The genetic
sequence of the SCs is edited via CRSP such that the SCs no
longer include a marker associated with the existence or
predisposition to DDD and even more preferably such that the
SCs come to include a marker associated with the absence or
non-predisposition to DDD (AKA a decreased risk or so-called
“protective” marker). The SCs are caused to initiate
differentiation into the tissue of choice, namely disk tissue. The
SCs are administered to the patient via injection into at least
one disk of the patient. It is noted that because the SC
administration is an autogeneic administration, the SCs have a
very high likelihood of acceptance (i.e. will not be rejected by
the patient's immune system) and yet the SCs will stimulate
regeneration of disk material that is not predisposed to DDD.
(Spec. ¶ 8 (emphasis added).) Thus, the second embodiment of Appellant’s
invention, describes a method of preparing a SC composition and
administering this composition to a patient, wherein:
(a) a patient is determined to be genetically predisposed
to degenerative disk disease (DDD) or to have clinical
indications of DDD or both,
(b) a quantity of SCs is obtained from the patient,
(c) the SCs are genetically screen[ed] (e.g. genetically
sequenced and analyzed),
(d) at least one marker associated with the existence or
predisposition to DDD (AKA an increased risk or so-called
“causative” marker) is identified,
(e) the genetic sequence of the SCs is edited via CRSP
such that the SCs no longer include a marker associated with
the existence or predisposition to DDD and even more
preferably such that the SCs come to include a marker
associated with the absence or non-predisposition to DDD
(AKA a decreased risk or so-called “protective” marker),
Appeal 2018-004583
Application 15/421,186

5
(f) the SCs are caused to initiate differentiation into the
tissue of choice, namely disk tissue, and
(g) the SCs are administered to the patient via injection
into at least one disk of the patient.
(See id. (lettering and emphasis added).)
As Appellant makes clear, this second embodiment of Appellant’s
invention describes an autogeneic administration of SCs and, therefore,
these SCs have a very high likelihood of acceptance (i.e. will not be rejected
by the patient's immune system). This second embodiment of Appellant’s
invention encompasses a treatment of DDD, wherein the SCs will stimulate
regeneration of disk material that is not predisposed to DDD (id.). In
addition, Appellant discloses that although the second embodiment is
described in relation to DDD, “a process substantially similar to the above
may be used in administering SCs to address virtually any genetic condition”
(id. ¶ 9).
Appellant further discloses that “[t]he scope of the invention is . . .
indicated by the appended claims rather than by the foregoing description.
All changes which come within the meaning and range of equivalency of the
claims are to be embraced within their scope” (id. ¶ 10).
In a departure from the language in the Specification describing the
embodiments of Appellant’s invention as “a method of preparing an SC
composition and administering the SC composition to a patient,” Appellant’s
claim 1 recites a treatment method (Spec. ¶¶ 7–8; cf. App. Br. 32). The
treatment method of Appellant’s claim 1 comprises the following steps:
(a) obtaining at least one SC from a patient determined
to have or be predisposed to at least one genetic condition,
(b) identifying at least one marker associated with an
increased risk of said condition in said at least one SC,
Appeal 2018-004583
Application 15/421,186

6
(c) editing the genetic sequence of said at least one SC
via CRSP such that at least one of the following is performed
comprising
(i) elimination of said condition increased risk associated
marker from said at least one SC and
(ii) introduction of a condition decreased risk associated
marker to said at least one SC,
(d) causing said at least one SC to initiate differentiation
into a predetermined tissue, [and]
(e) administering said edited at least one SC to said
patient.
(See App. Br. 32 (Claims App’x) (lettering and emphasis added).)
On this record, Examiner interprets Appellant’s claim 1 as an “ex-vivo
method[] of cell gene therapy to treat a genetic condition in a patient with
edited SCs via CRISPR” (Ans. 5). This interpretation is consistent with the
second embodiment of Appellant’s invention (see Spec. ¶ 8). Thus, based
on this interpretation of Appellant’s claim 1, Examiner pursues rejections
under the written description and enablement provisions of 35 U.S.C.
§ 112(a).
Appellant, however, insists that the treatment method of Appellant’s
claim 1 “does not teach or claim the treatment of a genetic disease in a
patient” (App. Br. 11), but rather “seeks prevention of a disease otherwise
caused by a disease associated marker by eliminating the disease associated
marker” (id. at 7). As Appellant explains,
if a disease would otherwise have been developed due to the
presence of an increased risk marker in an SC that is to be
administered to a patient but that SC is edited pre-
administration to eliminate such increased risk marker, the

Appeal 2018-004583
Application 15/421,186

7
patient will not develop such disease due to the elimination of
such increased risk marker.
(App. Br. 11.) Stated differently, rather than interpreting Appellant’s claim
1 in the context of the second embodiment of Appellant’s claimed invention,
Appellant insists that claim 1 must be interpreted in the context of the first
embodiment of Appellant’s claimed invention, wherein if at least one marker
associated with the existence or predisposition to at least one genetic
condition is identified in donor SCs, the donor SCs are treated, or altered,
such that the SCs no longer include a marker associated with the existence or
predisposition to the at least one genetic condition, prior to administration to
a patient, for whatever purpose (see Spec. ¶ 7). Thus, Appellant contends
that Examiner’s rejections under 35 U.S.C. § 112(a) are based on an
incorrect interpretation of Appellant’s claimed invention (see generally App.
Br. 13 (“[t]he failure of the [E]xaminer to acknowledge that the claims do
not claim the ‘treatment of a genetic condition in a patient’ is a fundamental
flaw that runs throughout the [E]xaminer’s examination and has tainted the
[E]xaminer’s decisions.”)).
At this point, prior to addressing the merits of the rejections under
35 U.S.C. § 112(a), we must step back and
determine whether the claims do, in fact, set out and
circumscribe a particular area with a reasonable degree of
precision and particularity. It is here where the definiteness of
the language employed must be analyzed— not in a vacuum,
but always in light of the teachings of the prior art and of the
particular application disclosure as it would be interpreted by
one possessing the ordinary level of skill in the pertinent art.
In re Moore, 439 F.2d 1232, 1235 (CCPA 1971) (endnote omitted). It is
only “having determined that the subject matter defined by the claims is
particular and definite, [that] the analysis . . . turns to the first paragraph of
Appeal 2018-004583
Application 15/421,186

8
section 112 to determine whether the scope of protection sought is supported
and justified by the specification disclosure.” Id.
The legal standard for indefiniteness under 35 U.S.C § 112(b) is
whether a claim reasonably apprises those of skill in the art of its scope. See
Amgen, Inc. v. Chugai Pharm. Co., 927 F.2d 1200, 1217 (Fed. Cir. 1991).
On this record, it is clear that Appellant’s claim 1 does not meet this
standard. To the contrary, for the reasons set forth above, and articulated by
Examiner and Appellant, it is clear that Appellant’s claim 1 is amenable to
various interpretations. Stated differently, Appellant’s claimed invention is
indefinite. Ex Parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008)
(precedential) (“if a claim is amenable to two or more plausible claim
constructions, the USPTO is justified in requiring the applicant to more
precisely define the metes and bounds of the claimed invention by holding
the claim unpatentable under 35 U.S.C. § 112, second paragraph, as
indefinite.”).
Thus, Appellant’s claim 1 is rejected under 35 U.S.C. § 112(b).
Note, 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.

35 U.S.C. § 112(a):
Because an analysis under 35 U.S.C. § 112(a) cannot proceed until the
metes and bounds of that claims is determined under § 112(b), we pro forma
reverse the rejections claims 1–22 under the written description and
Appeal 2018-004583
Application 15/421,186

9
enablement provisions of 35 U.S.C. § 112(a). We emphasize, however, that
our decision in this regard is based solely on the indefiniteness of the
claimed subject matter, and does not reflect on the adequacy of the
Specification to support the claimed subject matter. See Ex parte Miyazaki,
89 USPQ2d 1207, 1217-18 (BPAI 2008) (precedential) (prior art rejections
of indefinite claims reversed by Board “pro forma” where claim
interpretation required resort to “speculative assumptions as to the meaning
of the claims”).

TIME PERIOD FOR RESPONSE
This Decision contains a new ground of rejection pursuant to
37 C.F.R. § 41.50(b) (effective September 13, 2004, 69 Fed. Reg. 49960
(August 12, 2004), 1286 Off. Gaz. Pat. Office 21 (September 7, 2004)).
37 C.F.R. § 41.50(b) provides “[a] new ground of rejection pursuant to this
paragraph shall not be considered final for judicial review.”
37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO
MONTHS FROM THE DATE OF THE DECISION, must exercise one of
the following two options with respect to the new ground of rejection to
avoid termination of the appeal as to the rejected claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner. . . .

(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. . . .

Appeal 2018-004583
Application 15/421,186

10
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

REVERSED
37 C.F.R. § 41.50(b)