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 .
DETAILED ACTION
1. Applicant's amendment, filed 11/28/23 is acknowledged.
Claims 1-4, 9, 10, 26-35 are pending.
Claims 1-4, 9, 10, 26-35 read on a method of inducing ADCC of cancer cells and a method of treating cancer in a subject each comprising administering to the subject a modified NK cell exhibiting a loss of function of TGFbetaR2 and CISH and antibody, wherein administering induces ADCC are under consideration in the instant application.
2. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
3. Claims 1-4, 9, 10, 26-35 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20240010979 and US Patent Application 20250215396 in view of US Patent Application 20220143084 .
US Patent Application ‘979 teaches a method of treating cancer in a subject comprising administering to the subject a modified NK cells and antibody to induce ADCC in said subject ( see entire document, paragraphs 0003, 0034, 0040,0058,0061 and 0068 in particular).
US Patent Application ‘396 teaches a method of treating cancer in a subject comprising administering to the subject a modified NK cells and antibody that binds to cancer antigen to induce ADCC in said subject ( see entire document, paragraphs 0035, 0038, 0100, 0159, 0213, 0246 in particular).
US Patent Application’979 and US Patent Application ‘396 do not explicitly teach the use modified NK cells exhibiting a loss of function of TGFbeta R2 and CISH.
US Patent Application’084 teaches a method of treating cancer in the subject comprising administering to the subject a modified NK cells, wherein modified NK cells exhibits loss of function of TGFbeta R2 and CISH ( see entire document, paragraphs 0008, 0010, 0012, 0036, 0076 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use modified NK cells taught by US Patent Application ‘084 in a method of treating cancer taught by US Patent Application’979 and US Patent Application ‘396 with a reasonable expectation of success because the prior art suggests that each of said modified NK cells can be used for treating cancer and inducing ADCC.
Claims 4, 10 are included because said functional features would be an inherent/obvious feature of administering a modified NK cells exhibits loss of function of TGFbeta R2 and CISH and antibody to induce ADCC. When the prior art method is the same as a method described in the specification, it can be assumed the method will inherently/obviously perform the claimed process. See MPEP 2112.02.
If the prior art structure is capable of performing the intended use, then it meets the claim. For example in Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999); the following was noted. “Artisans of ordinary skill may not recognize the inherent characteristics or functioning of the prior art. However, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. “ The Court further held that “this same reasoning holds true when it is not a property but an ingredient which is inherently contained in the prior art”. See MPEP 2112.02. Also, see Bristol-Myers Squibb Co. v. Ben Venue Laboratories, Inc. 58 USPQ2d 1508 (CA FC 2001); Ex parte Novitski 26 USPQ 1389 (BPAI 1993); Mehl/Biophile International Corp. V. Milgraum, 52 USPQ2d 1303 (Fed. Cir. 1999); Atlas Powder Co. V. IRECO, 51 USPQ2d 1943 (Fed. Cir. 1999).
Claims 27 -35 are included because it would be conventional and within the skill of the art to : (i) identify the specific antibody that binds to particular cancer antigen; (ii) determine an optimal means and timing of administering NK cells and antibody; Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
4. 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.
5. The claims 1-4, 9, 10, 26-35 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application Nos: 20240254444 and 20220143084 each in view of US Patent Application 20240010979 and US Patent Application 20250215396.
The claims of copending Application Nos: 20240254444 and 20220143084 each recited a modified NK cells, wherein modified NK cells exhibits loss of function of TGFbeta R2 and CISH that can be used for treating cancer.
US Patent Application ‘979 teaches a method of treating cancer in a subject comprising administering to the subject a modified NK cells and antibody to induce ADCC in said subject ( see entire document, paragraphs 0003, 0034, 0040,0058,0061 and 0068 in particular).
US Patent Application ‘396 teaches a method of treating cancer in a subject comprising administering to the subject a modified NK cells and antibody that binds to cancer antigen to induce ADCC in said subject ( see entire document, paragraphs 0035, 0038, 0100, 0159, 0213, 0246 in particular).
Thus it would have been to one of ordinary skill in the art before the effective filing date of the claimed invention to use modified NK cells recited in claims of copending applications 20240254444 and 20220143084 in a method of treating cancer taught by US Patent Application’979 and US Patent Application ‘396 with a reasonable expectation of success because the prior art suggests that each of said modified NK cells can be used for treating cancer and inducing ADCC.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
6. No claim is allowed.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/272-0840. The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644