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 02/20/26 is acknowledged.
2. Claims 12-31 are pending.
3. Claims 12-23 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 24-31 read on a composition comprising genetically modified Notch-expanded HSPCs are under consideration in the instant application.
4. 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.
5. Claims 24-31 are rejected under 35 U.S.C. 103 as being unpatentable over De Oliveira et al ( Human Gene Therapy, 2013, v.24,pages 824-830 and De Oliveira et al. Blood, 2011, v.118, pp1784 ) in view of US Patent Application 20180142212 for the same reasons set forth in the previous Office Action, mailed on 08/20/25.
Applicant’s arguments filed on 02/2026 have been fully considered but have not been found convincing.
Applicant asserts that as amended the claims now recited that genetically modified Notch-expanded HSPCs can engraft when administered and can differentiate in vivo and in vitro. None of the prior art references teach or suggest said feature and one of ordinary skill in the art would not have reasonable expectation of success.
Contrary to Applicant’s assertion it is noted that the instant claims are drawn to a product, i.e. genetically modified Notch-expanded HSPCs not to the method of engraftment or in vivo or in vitro differentiation.
It is the Examiner’s position that newly recited feature of claimed genetically modified HSPCs cells only limits the claims to the extent that the prior art must be capable of performing the purpose or intended use.
Applicant’s provide no evidence or declaration of why it would not be obvious or why skilled in the art would not expect that Notch-expanded HSPCs of the prior art would not be able to engraft when administered and differentiate in vivo and in vitro.
As has been stated previously, De Oliveira et al., teach a genetically modified CD34+ HSPCs cells expressing CAR, wherein extracellular domain is specific for binding CD19 De Oliveira et al., further teach that intracellular domain of said CAR comprises CD3 Xi or CD28 signaling domain ( ( see entire document, Abstract and Material and Method and Fig 1 in particular).
De Oliveira et al., do not teach Notch-expanded HSPCs.
US Patent Application’212 teaches that expanding HSPCs in the culture medium with Notch improve culturing surviving and in vivo repopulation ability of HSPCs ( see entire document, 0043).
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 Notch to expand genetically modified CD34+ HSPCs cells taught by De Oliveira et al with a reasonable expectation of success because the prior art suggests that expanding HSPCs in the culture medium with Notch improve culturing surviving and in vivo repopulation ability of HSPCs.
Claims 29-30 are included because it would be conventional and within the skill of the art to : (i) determine an optimal structure of extracellular domain of CAR. 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.
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. The claims 24-31 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application US 20230017590 A1; in view of De Oliveira et al ( Human Gene Therapy, 2013, v.24,pages 824-830
The claims of copending Applications No. US 20230017590 A1; each recited a composition comprising Notch-expanded HSPCs.
De Oliveira et al., teach a genetically modified CD34+ HSPCs cells expressing CAR, wherein extracellular domain is specific for binding CD19 De Oliveira et al., further teach that intracellular domain of said CAR comprises CD3 Xi or CD28 signaling domain.
It would be immediately obvious to one skill in the art to substitute HSPCs recited in the claims of U.S. Patent No. US 20230017590 A1 with genetically modified CD34+ HSPCs cells expressing CAR with a reasonable expectation of success because the prior art suggests both HSPCs are commonly used for immunotherapy.
Applicant requested that said rejection be held in abeyance until the claims are deem to be in condition for allowance.
9. Claims 24-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of US Patent Application 10813949 in view of De Oliveira et al ( Human Gene Therapy, 2013, v.24,pages 824-830
De Oliveira et al., teach a genetically modified CD34+ HSPCs cells expressing CAR, wherein extracellular domain is specific for binding CD19 De Oliveira et al., further teach that intracellular domain of said CAR comprises CD3 Xi or CD28 signaling domain.
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 genetically modified Notch -expanded CD34+ HSPCs cells expressing CAR that are used in methods recited in claims 1-26 of US Patent Application 10813949 and was disclosed in the specification of said Patent.
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.
Applicant requested that said rejection be held in abeyance until the claims are deem to be in condition for allowance.
10. Claims 24-31 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Applications US 20220218759 A1; US 20200009194 A1; US 20240041933 A1 each in view of De Oliveira et al ( Human Gene Therapy, 2013, v.24,pages 824-830
De Oliveira et al., teach a genetically modified CD34+ HSPCs cells expressing CAR, wherein extracellular domain is specific for binding CD19 De Oliveira et al., further teach that intracellular domain of said CAR comprises CD3 Xi or CD28 signaling domain.
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 genetically modified Notch -expanded CD34+ HSPCs cells expressing CAR that are used in methods of copending Applications US 20220218759 A1; US 20200009194 ; US 20240041933 A1 and was disclosed in the specification of said Patent.
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.
Applicant requested that said rejection be held in abeyance until the claims are deem to be in condition for allowance.
11. No claim is allowed.
12. THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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.
13. 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
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644