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. Claims 327-346 are pending.
2. Applicant’s election without traverse of Group I, claims 327-341 in the reply filed on 07/27/26 is acknowledged.
3. Claims 342-346 are withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 327-341 read on an engineered cell that increase expression of CD47 are under consideration in the instant application.
4. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
5. 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.
6. Claims 327-341 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by or alternatively as been obvious over US Patent Application 20220049226 or US Patent Application 20230348862
US Patent Application’226 teaches an engineered cells that increases expression of CD47. US Patent Application’226 teaches that said cells comprises an inducible promotor, such as CAG or EF1, operably linked to an exogenous polynucleotide encoding CD47. US Patent Application’226 teaches that said cells can be T cells. US Patent Application’226 teaches that said cells also modified to reduced expression of MHC class I or class II molecules ( see entire document, paragraphs, 0049,0070, 0086, 0231, 0237 in particular).
US Patent Application’862 teaches an engineered cells that increases expression of CD47. US Patent Application’862 teaches that said cells comprises an inducible promotor, such as CAG or EF1, operably linked to an exogenous polynucleotide encoding CD47. US Patent Application’226 teaches that said cells can be pluripotent stem cells. US Patent Application’226 teaches that said cells also modified to reduced expression of MHC class Ior class II molecules ( see entire document, paragraphs, 0010,0012,0024, 0039, 0177 in particular).
Claims 329, 332, 334 are included because it would be conventional and within the skill of the art to : (i) engineered cell with the targeted level of overexpression of CD47, (ii) determine specific MHC class I or class II molecules to reduced expression 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).
The reference teaching anticipates or alternatively would be obvious of the claimed invention.
7. 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.
8. Claim327-341 are provisionally rejected on the grounds of nonstatutory double patenting of the claim of copending Application No. 18/682,797; 18/682,782; 18/682,798; 18/597,148; 18/561,682; 17/792,121; 17/637,789, 17/632026;
Although the conflicting claims are not identical, they are not patentably distinct from each other because claim of copending Application No. 18/682,797; 18/682,782; 18/682,798; 18/597,148; 18/561,682; 17/792,121; 17/637,789, 17/632026 each recited an engineered cell comprising modification that reduce expression of one or more MCH class I and/or MCH class II molecules and increase expression of CD47.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
9. Claims 327-341 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of co-pending Applications 18/030880, 18/722,924, 18/727,670; 17/907,084; 17/997,103;17/401,174; 18/021036
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of the instant Application are drawn to an engineered cell comprising modification that reduce expression of one or more MCH class I and/or MCH class II molecules and increase expression of CD47 that was used in methods of treating recited in claims of co-pending Applications 18/030880, 18/722,924, 18/727,670; 17/907,084; 17/997,103;17/401,174; 18/021036, and wherein said cell was disclosed in the specification of said Patents Applications.
This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
10. No claim is allowed.
11. 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
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