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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. Applicants amendment filed on 01/12/26 is acknowledged.
2. Claims 21-30 are pending.
Claims 21-30 read on a method of increasing angiogenesis in a patient comprising administering ex-vivo expanded population of gamma delta T cells are under consideration in the instant application.
The following new grounds of rejection is necessitated by the amendments filed on 01/12/26
3. 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.
4. Claims 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20240148828 and US Patent Application 20230408523 in view of US Patent Application 20220135678, Benzaid et al ( Cancer Research, 2019,v.79,no13, Abstract 934) , US Patent Application 20230063829
US Patent Application ‘828 teaches a method of treating a patient comprising administering to the patient ex-vivo expanded population of gamma delta T cells. US Patent Application ‘828 teaches that the culture medium for expanding gamma delta T cells comprises IL2 or IL-15 ( see entire document, paragraphs 0004, 0026,0027, 0048, 0049, 0068, 0138, 0214, 0390, )
US Patent Application ‘523 teaches a method of treating a patient comprising administering to the patient ex-vivo expanded population of gamma delta T cells US Patent Application ‘523 teaches that the culture medium for expanding gamma delta T cells comprises IL2 or IL-15 ( see entire document, paragraphs 0008-0010, 0031, 138, 0159 0211)
US Patent Application ‘828 and US Patent Application ‘523 do not explicitly teach identifying patient suffering from non-cancerous degenerative disorder, generating CAR-T cells from said gamma delta T and co-culturing gamma delta T in the presence of MSCs or condition medium from MSCs.
US Patent Application’ 678 teaches the use of CAR-T cell immunotherapy for treatment of non-cancerous degenerative disorder in a patient ( see entire document, paragraphs 0089
Benzaid et al., teach a method of generating CAT T cells from gamma delta T cells comprising transducing gamma delta T cells with nucleic acid encoding CAR that can be used for immunotherapy ( see entire document, Abstract inparticular))
US Patent Application’ 829 teaches co-culturing gamma delta T cells with MSCs enhances gamma delta T cells survival and immunotherapy potential ( see entire document paragraph 0038 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 identify a patient suffering from generative disorder, generate gamma delta CAR-T from gamma delta T cells taught by US Patent Application ‘828 and US Patent Application ‘523 and co-culture them in the presence of MSCs with a reasonable expectation of success because the prior art suggests that generated gamma delta T cells can be used for immunotherapy in a patient suffering from degenerative disorder from and that survival and immunotherapy potential of said cells can be increase by co-culturing in the presence of MSCs.
Claims 23-30 are included because it would be conventional and within the skill of the art to : (i) identify an optimal source of obtaining MSCs; (ii) means of obtaining gamma delta T cells 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).
It is noted that though US Patent Application ‘828 and US Patent Application ‘523 do not explicitly teaches a method of increasing angiogenesis in a patient said functional properties would be an inherent/obvious properties of the claimed method of administering to the patient ex-vivo expanded population of gamma delta CAR-T cells because the claimed and recited gamma delta T cells are essentially the same.
If the prior art structure (ex vivo expanded population of gamma delta CAR-T cells) 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).
When a claim recites using an old composition or structure (e.g. ex vivo expanded population of gamma delta T cells) and the use is directed to a result or property of that composition or structure (treting a degerative conditions) then the claim is anticipated. 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).
From the combined teaching of the references, it is 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.
5. 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. Claims 21-30 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application Nos. US 20240216472; US 20240100160 in view of US Patent Application 20220135678, Benzaid et al ( Cancer Research, 2019,v.79,no13, Abstract 934) , US Patent Application 20230063829.
Claims of copending Application Nos. US 20240216472; US 20240100160 ; each recited a method of treating a patient comprising administering to the patient ex vivo expanding population of gamma delta T cells.
US Patent Application’ 678 teaches the use of CAR-T cell immunotherapy for treatment of non-cancerous degenerative disorder in a patient ( see entire document, paragraphs 0089
Benzaid et al., teach a method of generating CAT T cells from gamma delta T cells comprising transducing gamma delta T cells with nucleic acid encoding CAR that can be used for immunotherapy ( see entire document, Abstract inparticular))
US Patent Application’ 829 teaches co-culturing gamma delta T cells with MSCs enhances gamma delta T cells survival and immunotherapy potential ( see entire document paragraph 0038 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 identify a patient suffering from generative disorder generate gamma delta CAR-T from gamma delta T cells recited in claims of co-pending applications Nos. US 20240216472; US 20240100160 and co-culture them in the presence of MSCs with a reasonable expectation of success because the prior art suggests that generated gamma delta T cells can be used for immunotherapy in a patient suffering from degenerative disorder from and that survival and immunotherapy potential of said cells can be increase by co-culturing in the presence of MSCs.
It is noted that though claims of copending Application Nos. Nos. US 20240216472; US 20240100160 do not explicitly recited a method of treating a degenerative condition, said functional properties would be an inherent/obvious properties of the claimed method of administering to the patient ex-vivo expanded population of gamma delta CAR-T cells because the claimed and recited gamma delta CAR-T cells are essentially the same.
When a claim recites using an old composition or structure (e.g. ex vivo expanded population of gamma delta T cells) and the use is directed to a result or property of that composition or structure (treting a degerative conditions) then the claim is anticipated. 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).
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
6. No claim is allowed.
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). 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 extension fee 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.
8. 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, Gregory Emch can be reached on 571/ 272-8149.
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