LESCH, Hanna P. et al.

Patent Trials and Appeals Board

Mar 27, 2020

15306830 - (D) (P.T.A.B. Mar. 27, 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.
15/306,830 10/26/2016 Hanna P. LESCH GB14/17042.7 6260
22925 7590 03/27/2020
Pharmaceutical Patent Attorneys, LLC
801 Brickell Avenue
9th Floor #9101
Miami, FL 33131-4924
EXAMINER
MONTANARI, DAVID A
ART UNIT PAPER NUMBER
1632
NOTIFICATION DATE DELIVERY MODE
03/27/2020 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):
administration@LicensingLaw.net
docket@LicensingLaw.net
mark.pohl@licensinglaw.net
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte HANNA P. LESCH, NIGEL PARKER, MINNA KARHINEN,
ROBERT SHAW, SEPPO YLA-HERTTUALA, JOONAS MALINEN,
and EEVI LIPPONEN
________________________

Appeal 2019-003042
Application 15/306,830
Technology Center 1600
____________

Before ULRIKE W. JENKS, TAWEN CHANG, and
MICHAEL A. VALEK, Administrative Patent Judges.

VALEK, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 submits this appeal under 35 U.S.C. § 134(a) involving
claims to a method for treating cancer by administering a gene therapy viral
vector, which have been rejected for indefiniteness and for being anticipated
by the cited prior art. 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 Trizell Limited as the real party in
interest. Appeal Br. 1.
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STATEMENT OF THE CASE
The inventors in the Specification state that they “have found a
counter-intuitive way to improve the commercial-scale production of
recombinant biological products in adherent-cell bioreactors.” Spec. 1.
According to the Specification:
The art teaches to seed adherent-cell bioreactors with cells
adapted to adherent culture. We tested the exact opposite
approach, and tried seeding an adherent-cell bioreactor with
suspension-adapted cells. We surprisingly found that not only
do suspension-adapted cells adhere to the substrate in the
adherent bioreactor, but those suspension-adapted cells thrive
when cultured in adherent mode, and using suspension-adapted
cells enables one to greatly reduce the amount of cells required
for seeding, and avoids clogging the substrate or carrier. The
present invention is thus based, at least in part, on the finding that
suspension-adapted cells (expanded in suspension culture) can
be successfully inoculated into an adherent-culture bioreactor,
and subsequently grown in adherent mode.
Spec. 4. The Specification explains that viral vectors, including those
comprising a “therapeutic transgene” can be produced “by transduction,
transfection or infection, of expanded cells inside the bioreactor.” Id. at 8–9.
Claims 29–31 are on appeal, and can be found in the Claims
Appendix. Claim 29 is representative and reads as follows:
29. A method for treating cancer in a human comprising:
a. Diagnosing cancer in a human; and then
b. Administering to said human the gene therapy
viral vector of claim 14 in an amount effective to combat
said cancer.
Appeal Br. 13. Claims 14 and 1, which are not themselves on appeal,
provide as follows:
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14. A gene therapy viral vector produced by the method of
Claim 1.
1. A method for the production of a recombinant biological
product, comprising:
(b) obtaining suspension-adapted cells; and
(c) inoculating the suspension-adapted cells
obtained in (b) into a bioreactor having a carrier
providing a surface area for adherent cell culture.
Id. at 10–11. Thus, the method in claim 29 makes use of the “gene therapy
viral vector,” i.e., the product, of claim 14, which in turn is produced by the
process recited in claim 1.
Appellant seeks review of the following grounds of rejection made by
Examiner:
I. Claims 29–31 under 35 U.S.C. § 112(b) for indefiniteness;
II. Claims 29–31 under 35 U.S.C. § 102 as anticipated by Mei;2
III. Claims 29–31 under 35 U.S.C. § 102 as anticipated by
Ramesh;3 and
IV. Claims 29–31 under 35 U.S.C. § 102 as anticipated by
Gregory.4
ANALYSIS
I. Indefiniteness
“[W]e apply the approach for assessing indefiniteness approved by the
Federal Circuit in Packard, i.e., ‘[a] claim is indefinite when it contains
words or phrases whose meaning is unclear.”’ Ex parte McAward, No.
2015-006416, 2017 WL 3669566, at *5 (PTAB Aug. 25, 2017)

2 US 2012/0283318 A1, published Nov. 8, 2012 (“Mei”).
3 US 2009/0004145 A1, published Jan. 1, 2009 (“Ramesh”).
4 US 2009/0088398 A1, published Apr. 2, 2009 (“Gregory”).
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(precedential) (quoting In re Packard, 751 F.3d 1307, 1310, 1314 (Fed. Cir.
2014)). “Put differently, ‘claims are required to be cast in clear-as opposed
to ambiguous, vague, indefinite-terms.”’ Id. (quoting Packard, 751 F.3d at
1313). “At the same time, this requirement is not a demand for unreasonable
precision.” Packard, 751 F.3d at 1313.
Examiner finds that claims 29–31 are unclear and therefore indefinite
because they “are drawn to treating cancer with a ‘gene therapy viral vector’
. . . produced in the method of claim 1.” Final Act. 7. According to
Examiner,
there is no gene therapy vector produced by the method in claim
1 because th[at] claim is directed to the production of a
recombinant biological product and does not recite a gene
therapy vector. Thus claims 29–31 remain unclear because they
depend from claims that are unclear and the metes and bounds
cannot be determined.
Id.
Appellant argues that claim 29 “does not require the ‘vector of claim
1,’ but rather “requires the ‘vector of claim 14.’ And claim 14 clearly and
unambiguously specifies ‘a gene therapy viral vector.’” Appeal Br. 6; Reply
Br. 1. Appellant further asserts that “[c]laim 14 recites both structural and
functional limitations” in that it requires a “vector with a viral structure” that
“include[s] an expressible foreign transgene” and “must be able to deliver
that expressible transgene into a host cell.” Reply Br. 2. Thus, urges
Appellant, the metes and bounds of the vector recited for use in the methods
of claims 29–31 is sufficiently clear. See id. at 1–2.
We determine that Appellant has the better position. Claim 29 recites
“administering . . . the gene therapy viral vector of claim 14,” and claim 14
clearly recites a “gene therapy viral vector.” That the vector is broadly
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recited and not limited to a particular gene therapy does not render the term
unclear to a skilled artisan. Moreover, while it is true that claim 1 does not
recite a gene therapy vector specifically, it does recite a method for making
“a recombinant biological product” generally. And the Specification makes
clear that a viral vector comprising a therapeutic transgene is a preferred
type of recombinant biological product that may be produced by the recited
method. See Spec. 8–9. Thus, we agree with Appellant that the scope of
claims 1 and 14, and by extension claims 29–31, is not unclear.
For these reasons, we reverse Examiner’s indefiniteness rejection.
II. Anticipation
As explained below, Examiner’s anticipation rejections are premised
on common legal and factual determinations. Moreover, Appellant presents
the same arguments for all three rejections. See Appeal Br. 7–9. We
therefore address these rejections together herein.
The issue for each of the anticipation rejections is whether the
preponderance of the evidence supports Examiner’s finding that the cited
reference discloses all of limitations of claims 29–31.
Findings of Fact
FF1. Mei discloses “the use of specific adenoviral vector systems for gene
therapy.” Mei ¶ 1. These vectors are produced by “insert[ing] heterologous
nucleic acid fragments” that encode, e.g., “human therapeutic proteins, and
cytokines,” into the viral genome, “thereby providing recombinant
adenovirus vectors.” Id. ¶¶ 19, 36, 38.
FF2. Mei discloses that its gene therapy viral vectors are used for “the
therapeutic, prophylactic or diagnostic treatment of a disease,” including
various types of cancer. Mei ¶¶ 50, 55. Mei further describes administering
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“a therapeutically effective amount of” its vector to “a human patient, in need
of such gene therapy.” Id. ¶ 99.
FF3. Ramesh discloses
methods for treating ovarian, breast, or lung cancer in a patient
comprising administering to the patient an effective amount of
an adenovirus vector comprising a nucleic acid sequence
encoding a therapeutic polypeptide . . . wherein the nucleic acid
sequence is under the control of a promoter capable of being
expressed in the patient.
Ramesh ¶ 14. Ramesh teaches these methods “include assessment of
a subject diagnosed with cancer” and that the subject or patient is
human. Id. ¶¶ 15, 34.
FF4. Gregory discloses “a recombinant adenovirus expression vector . . .
having a gene encoding a foreign protein” for use in gene therapy. Gregory,
Abstr, ¶ 56. Gregory discloses that the “vector is purified and then an
effective amount is administered in vivo or ex vivo into the subject,”
including a “human patient” suffering from various types of cancer. Id. at 56.
Analysis
Examiner finds that Mei, Ramesh and Gregory each individually
disclose a method for treating cancer in a human patient by administering an
effective amount of a gene therapy viral vector. See Final Act. 8–11.
Examiner determines that “claims 14–15 recite a gene therapy vector
produced by a method,” and therefore the “gene therapy viral vector” recited
in claims 29–31 “is a product-by-process limitation.” Id. at 9; see also Ans.
9. Thus, reasons Examiner, “the steps of obtaining suspension-adapted cells,
and the use of a bioreactor [as recited in claim 1] are not limitations of the
gene therapy vector” for purposes of determining novelty. Id. As such,
Examiner concludes the disclosure of gene therapy viral vectors to treat
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cancer patients5 in each one of the above references is sufficient to anticipate
claim 29–31, even though none of those references discloses the process in
claim 1. See Id.
We adopt the Examiner’s findings of fact and reasoning regarding
Mei (FF1–FF2), Ramesh (FF3), and Gregory (FF4) and agree that
Appellant’s claims are anticipated by each of these references. We are not
persuaded by Appellant’s argument that Examiner erred in interpreting these
claims such that the process steps of claim 1 were not included in assessing
the novelty of claims 29–31. See Appeal Br. 6–8. Claims 29–31 require
administration of a “gene therapy viral vector” as recited in claim 14.6 We
agree with Examiner that claim 14 is a product-by-process claim. Indeed,
Appellant does not dispute this point. See Reply Br. 4 (agreeing with
Examiner’s determination that claim 14 recites a “product-by-process
limitation”).
It is well-settled that “product-by-process claims are not limited to
the manipulations of the recited steps, only the structure implied by those
steps.” MPEP 2113(I) (reformatted). As our reviewing court has explained,
“even though product-by-process claims are limited by and
defined by the process, determination of patentability is based on
the product itself. . . . If the product in the product-by-process
claim is the same as or obvious from a product of the prior art,

5 With respect to step (a) “Diagnosing cancer in a human” in claims 29 and
30, Examiner determines that “administering [a therapy] to a patient with
cancer would inherently encompass diagnosing that the patient has cancer
prior to providing treatment for cancer.” Final Act. 8. Appellant does not
dispute that finding in its Appeal Brief.
6 Claim 30 recites administration of the “gene therapy viral vector of claim
15.” Appeal Br. 13. Claim 15 depends from claim 14.
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the claim is unpatentable even though the prior product was made
by a different process.”
In re Thorpe, 777 F.2d 695, 698 (Fed. Cir. 1985); see also SmithKline
Beecham Corp. v. Apoteex Corp., 439 F.3d 1312, 1317 (Fed. Cir. 2006) (“It
has long been established that one cannot avoid anticipation by an earlier
product disclosure by claiming the same product more narrowly, that is, by
claiming the product as produced by a particular process.”). Thus, while it is
true that claim 14 (and claims 29–31 by dependency) incorporate the process
steps of claim 1, those steps do not distinguish the recited “gene therapy
viral vector” from those in the prior art absent some showing that the recited
process imparts some distinctive structural characteristic on the resulting
vector. See MPEP 2113(I)-(II).
Appellant does not contend that the process steps in claim 1 confer
any distinctive structural characteristics on the “gene therapy viral vector” of
claim 14. To the contrary, in opposing the indefiniteness rejection,
Appellant identifies the structural requirements of the vector in claim 14 as:
(1) a vector having “a viral structure,” and (2) the vector “must include an
expressible foreign transgene.” Reply Br. 2. The viral vectors disclosed in
Mei, Ramesh, and Gregory meet both of those structural requirements. See
FF1–FF4. Moreover, each of those references teach that their vectors are
able to deliver the expressible transgene into a host cell for purposes of gene
therapy. Id. Accordingly, the methods of treating cancer disclosed in Mei,
Ramesh, and Gregory each involve administration of a gene therapy viral
vector with the same structure recited in Appellant’s claims.
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For these reasons, we determine that each of Examiner’s anticipation
rejections is supported by a preponderance of the evidence and therefore
affirm.
CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
29–31 112(b) Indefiniteness 29–31
29–31 102 Mei 29–31
29–31 102 Ramesh 29–31
29–31 102 Gregory 29–31
Overall
Outcome
29–31

AFFIRMED