Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed 11-14-25 are acknowledged.
Claims 42-44, 49, 74-77 and 84-99 are pending and under examination as they read on the species of invention of Group I wherein the immunomodulatory compound is “a cytokine” and wherein the sub-species of cytokine is “GM-CSF or IL-12.”
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 42-44, 49, 74-77 and 84-99 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12 of U.S. Patent No. 11033613 (hereinafter the “613”), in view of Fikes et al. (20040053822) and Iversen (20020025939)(all of record).
Applicant argues, “…the Examiner's rejection is inconsistent with the restriction requirements of record in the instant application and the applications from which the instant application claims benefit.
First, the Examiner in the instant application required restriction between the nucleic
acids encoding the peptides of SEQ ID NOs: 41 or 42, and vaccines and vectors comprising
said nucleic acids (Group I) and methods of making use of said nucleic acids (Group II). See
March 6, 2025, Restriction Requirement, p. 2. Second, in parent application 16/359,897, from
which the instant application claims benefit, the Examiner required restriction between A)
claims directed to nucleic acid molecules encoding peptides and vectors comprising said
nucleic acids (Group III), B) claims directed to therapeutic methods using compositions
comprising peptides (Group II), and C) claims directed to therapeutic methods using
compositions comprising nucleic acid molecules encoding peptides and vectors comprising
said nucleic acids (Group IV). See October 13, 2021, Restriction Requirement, pp. 2, in US
16/359,897. Thus, the Examiner in the instant application has indicated that claims to nucleic
acids, vaccines, and vectors, are separately patentable from claims to therapeutic methods of
using nucleic acids encoding peptides and claims to therapeutic methods of using peptides.
Moreover, during prosecution of the application which resulted in the '613 patent, the
Examiner required restriction between compositions comprising WTl peptides or nucleic acids
encoding said WTl peptides (Group I) and methods for treating, reducing the incidence of, or
inducing an immune response against a WTl-expressing cancer of using said WTl peptides or
nucleic acids encoding them (Group II). See the January 10, 2020, Restriction Requirement,
pp. 3-4, in the '613 patent. Thus, in both the instant application and the application leading to
the '613 patent, the Examiner has indicated that nucleic acids, and vectors, vaccines or
compositions comprising the nucleic acids are separately patentable from therapeutic methods.
As such, the Examiner's obviousness type double patenting rejection contradicts the positions
maintained by the Examiner in the restriction requirements issued in both the instant
application and the '613 patent.
For at least the foregoing reasons, the pending claims are not obviousness type double
patenting over claims 1-12 of the '613 patent in view of Fikes and Iverson.”
Applicant's argument has been considered but has not been found convincing essentially for the reasons of record and as further described below.
By contrast to applicant’s arguments, the instant application is not a “divisional” of the reference application because the instant application claims the benefit of priority of at least PCT/US07/08853 which was filed (4-10-07), well before the earliest filing date associated with the reference patent application (62258134, 11-20-15).
In essence, applicant appears to be arguing that the instant application is at least in principal a divisional of the ‘613 reference patent.
However, for a US patent application to be an authentic divisional, and to receive the statutory benefits associated with 35 USC § 121, it must be filed as a direct result of a formal USPTO restriction requirement, which is not possible in this situation.
See MPEP § 804.01
Thus, applicant’s argument is not found convincing and the claims stand rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-12 of the ‘613, in view of the teachings of Fikes and Iversen.
Claims 42-44, 49, 74-77 and 84-99 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-17 of U.S. Patent No. 11548924 (hereinafter the “924”), in view of Fikes et al. (20040053822) and Iversen (20020025939)(all of record).
Applicant argues: “the Examiner's rejection is inconsistent with the restriction requirements of record in the instant application and the applications from which the instant application claims benefit.
The instant claims are directed to certain specific nucleic acids, and vaccines, vectors and pharmaceutical compositions comprising said nucleic acids. By contrast, claims 1-17 of
the '924 patent are directed to isolated WTl peptides.
In grandparent application 14/995,955, from which the instant application claims benefit, the Examiner required restriction between A) claims directed to peptides and compositions comprising said peptides (Group I); and B) claims directed to polynucleotides and vectors thereof (Group II). Thus, during the prosecution of the grandparent application to the instant application, the Examiner indicated that claims to nucleic acids separately patentable from claims to peptides. That restriction requirement is contrary to the Examiner's argument regarding the obviousness type double patenting rejection in the instant application.
For at least the foregoing reasons, the pending claims are not obviousness type double patenting over claims 1-17 of the '924 patent in view of Fikes and Iverson.”
Applicant's argument has been considered but has not been found convincing essentially for the reasons of record and for the same reasons set forth above.
In essence, the instant application is not a divisional of the application that served as the basis for the 924 reference patent and thus the instant application is not entitled to “safe harbor” protection under 35 USC § 121 from the 924 reference patent claims.
In conclusion, applicant’s argument is not found convincing and the claims stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of the 924 in view of Fikes and Iversen.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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