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 11/18/25 is acknowledged.
2. Claims 21, 23-29, 31-34.36-51 are pending.
3. It is noted that newly submitted claim 51 is drawn to non-elected invention. Accordingly, claim 51 is withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention.
Claims 21, 23-29, 31-34.36-50 read on a method of treating a human subject in need comprising administering a population of HSPCs regulatory T cells and CD3+ conventional T cells as recited in claim 21 are under consideration in the instant application.
4. Claims 21, 23-29, 31-34.36-50 are rejected under 35 U.S.C. 112, first paragraph, as containing subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a New Matter rejection.
-“ A method of treating a human subject in need thereof comprising separately administering or having administered …”
-“ isolated HSPCs and isolated Treg are separately administered to the subject on the same day…”
- “administration of the CD3+ conventional T cells is administered between day 2 to day 3 after administration of the population of isolated HSPC… “
claimed in 21 represent a departure from the specification and claims as originally filed.
All the passages pointed by Applicant do not support newly claimed
-“ A method of treating a human subject in need thereof comprising separately administering or having administered …”
-“ isolated HSPCs and isolated Treg are separately administered to the subject on the same day…”
- “administration of the CD3+ conventional T cells is administered between day 2 to day 3 after administration of the population of isolated HSPC… “
The specification and the claims as originally field only support “ A method of treating a human subject in need thereof comprising of administering…”
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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). A registered attorney or agent of record may sign a terminal disclaimer.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit https://www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form 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 [ 1 ].
6. The claims 21, 23-29, 31-34.36-50 are rejected on the grounds of nonstatutory double patenting of the claims 1-22 of US Patent 11/952,588. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1-22 of US Patent 11/952,588 recite a method of treating a human comprising administering administering a population of HSPCs regulatory T cells and CD3+ conventional T cells.
It is noted that claims 1-22 of US Patent’588 do not explicitly recited the timing and sequences of administering HSPCs, T reg and CD3+ T cells as instantly claimed.
It is the Examiner’s position that it would be conventional and within the skill of the art to determine the optimum timing and sequences of administering HSPCs, T reg and CD3+ 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).
7. The claims 21, 23-29, 31-34.36-50 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application US 20230372393. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims of copending Application 20230372393 recite composition that is used in the instantly claimed method of treating.
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.
The shield against double patenting rejections provided by 35 USC 121 does not apply here as the instant application was not filed as a divisional and or continuation application in response to a restriction requirement in the patent Application 17/031,187.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
8. No claim is allowed.
9. THIS ACTION IS MADE FINAL even though it is a first action in this case. 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, however, event will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
10. 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