Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-6 are pending and under examination.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The specification generally teaches the treatment of HIV by administering a the claimed NK cells expressing a TCR that recognizes an HIV- or an HIV-associated antigen (see claim 57 and at page 9, 3rd paragraph).
However, given the knowledge in the art of the T-cell immune response to HIV infection the skilled artisan would not have a reasonable expectation of successfully treating this disease with the claimed TCR gene modified NK cells. The ordinarily skilled artisan would have considered treatment of HIV infection by administration of the claimed TCR gene modified NK cells particularly unpredictable, and not achievable in the absence of undue trial-and-error experimentation because multiple features of HIV that allow it to escape endogenous cytotoxic T-lymphocyte (CTL) immune control will also thwart efforts to treat the disease with TCR modified NK cells.
For example, as described by Roeth et al. (The Journal of Cell Biology, Vol. 167, No. 5, December 6, 2004 903–913, cited herewith), the HIV expressed Nef protein prevents recognition and killing by host cytotoxic T lymphocytes (CTLs) by reducing “…the cell surface expression
of major histocompatibility complex class I molecules (MHC-I) (Schwartz et al., 1996), which are needed to present antigenic peptides to CTLs;” in particular, expression of the HLA-A and HLA-B allotypes (see page 903, Introduction, 1st and 3rd full paragraphs). Likewise, as described by Carlson et al. (Trends Microbiol. 2015 Apr;23(4):212-24, cited herewith), additional factors that inhibit the ability of endogenous T-cells to recognize HIV-infected T-cells are related the mutagenic qualities of HIV which enable various T-cell immune escape mechanisms (see, e.g., at Fig. 1B-D and in the section entitled “HIV-1 immune escape is predictable based on host HLA”).
Indeed, while the teachings of Riley et al. (The Journal of Infectious Diseases, 2017;215
(S3):S160–71, cited herewith) were published subsequent to applicant’s earliest filed provisional application, this publication nonetheless describes summarizes various reasons why cells genetically modified to express an HIC-specific MHC class I restricted TCR were not yet expected, even after applicant’s first filed application, to be successfully used for the treatment of HIV (see page S164-65 bridging paragraph).
In sum, in view of the quantity of experimentation necessary, the limited working examples, the unpredictability of the art, the lack of sufficient guidance in the specification, and the breadth of the claims, it would take undue trial and error experimentation to practice the claimed invention.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 12-15 of U.S. Patent No. 11752172, cited herewith. Although the claims at issue are not identical, they are not patentably distinct from each other because the methods of treating melanoma by administering the TCR modified natural killer cells of reference claim 1 anticipate claims 1-5 of the instant application.
No claims are allowed.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644
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