DETAILED ACTION
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 .
The response filed on 05/11/2026 has been received and entered. Claims 22, 23, 25-41 remain pending, all of which have been examined on the merits.
Priority
The instant application was filed under 35 USC 121 as a divisional of prior-filed US application 16/622,237 (filed 12/12/2019; now US Patent 11851677); however, as a result of amendments to the claims, the application is an improper divisional, as the claims presented for examination are not commensurate in scope with those which were identified as patentably distinct from the invention examined in the parent application. A divisional application is “a later application for an independent or distinct invention” See MPEP 201.06.
The claims presented for examination in the instant application are not consonant with claims of Group II of the parent application because claim 22 of the instant application has been amended to require an active step differentiating induced definitive hemogenic endothelium (iHE) cells in a medium comprising a ROCK inhibitor and MCSF to produce a population of induced myeloid suppressive cells. The claims of Group II (claims 21-23) of the parent application (16/622,237) require administering a population of induced myeloid suppressive cells obtained by the method of claim 1 of application 16/622,237. Thus, Group II of application 16/622,237 did not require an active step of producing myeloid suppressive cells; it only requires the cell (i.e. the final product) produced by the method of the claim 1.
Applicants must amend the filing to indicate the instant application as a continuation under 35 USC 120, and are not afforded the benefit of the ‘121 shield.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 22, 23, 26, 28, 29, 31, 38, and 40
Amendments to the claims overcome the objection. The objection is withdrawn.
RE: Rejection of claims 26-28 and 31 under 35 U.S.C 112(b)
Amendments to the claims overcome the rejection of record. The rejection is withdrawn.
RE: Rejection of claims 22, 23, 26-29, 33-35 under 35 U.S.C. 102 over Messmann et al (Blood, 2015).
Applicants’ amendments requiring an active step of “obtaining a population of induced immune regulatory cells comprising induced myeloid suppressive cells by directing differentiation of iHE cells with a medium composition comprising a ROCK inhibitor and MCSF” overcomes the rejection of record.
The rejection is withdrawn.
RE: Rejection of claims 22, 23, 26, 28, 29, 33-35 under 35 U.S.C. 102 over Chen (WO2012054747A2).
Applicants’ amendments requiring an active step of “obtaining a population of induced immune regulatory cells comprising induced myeloid suppressive cells by directing differentiation of iHE cells with a medium composition comprising a ROCK inhibitor and MCSF” overcomes the rejection of record.
The rejection is withdrawn.
RE: Rejection of claims 22, 23, 26, and 28-35 under 35 U.S.C. 103 over Chen (WO2012054747A2) in view of Torikai et al (Blood, 2013).
Applicants’ amendments requiring an active step of “obtaining a population of induced immune regulatory cells comprising induced myeloid suppressive cells by directing differentiation of iHE cells with a medium composition comprising a ROCK inhibitor and MCSF” overcomes the rejection of record.
The rejection is withdrawn.
New Rejections
Double Patenting
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.
Claims 22, 23, and 26-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Shin (U.S. Patent No. 11,851,677). Although the claims at issue are not identical, they are not patentably distinct for the following reasons:
Regarding claim 22: Claim 22 of the instant application is drawn to a method of treating a subject in need of cell therapy comprising:
Obtaining a population of induced immune regulatory cells comprising induced myeloid suppressive cells by directing differentiation of iHE cells with a medium composition comprising a ROCK inhibitor and MCSF; and
Providing a therapeutically sufficient number of induced myeloid suppressive cells for administration to the subject.
Claim 1 of Shin discloses an invitro method of generating a population of induced immune regulatory cells, comprising:
Obtaining iHE cells; and
Directing differentiation of iHE with a medium composition comprising ROCK inhibitor, GMCSF, and MCSF;
Thereby generating a population of induced immune regulatory cells comprising induced myeloid suppressive cells, wherein the induced myeloid suppressive cells are CD45+ and CD33+.
Thus, claim 1 of Shin anticipates step (a) of the instant application. Additionally, claim 1 of Shin
discloses the method of steps (i)-(ii) produced a population of induced myeloid suppressive cells with enhanced therapeutic potential, thus, it would have been obvious to produce a therapeutically sufficient number of induced myeloid suppressive cells which reads on (b) of the instant claim.
Regarding claim 23: Following the discussion of claim 22 above, claim 2k) of Shin discloses the induced myeloid derived suppressor cells (MDSCs) produced by the method of claim 1 of Shin have improved potency in suppressing T cell proliferation and effector function and ability in attenuating GvHD. Thus, while Shin does not claim a method of treating a subject with GvHD, it would have been prima facie obvious to a person of ordinary skill in the art to use the MDSCs of Shin to treat a subject with GvHD because Shin discloses MDSCs with the ability to attenuate GvHD. There is a reasonable expectation of success because Shin discloses producing MDSCs with the ability to attenuate GvHD.
Regarding claim 26: Following the discussion of claim 22 above, claim 2 of Shin discloses limitations a)-d) which anticipate limitations (a)-(d) of the instant claim.
Regarding claim 27: Following the discussion of claim 22 above, claim 2 of Shin discloses limitations e)(1)-(5) which anticipate limitations (a)-(e) of the instant claim.
Regarding claim 28: Following the discussion of claim 22 above, claim 2 of Shin discloses limitations f)-k) which anticipate limitations (a)-(f) of the instant claim.
Regarding claim 29: Following the discussion of claims 22 and 28 above, claim 3 of Shin discloses limitations a)-d) which anticipate limitations (a)-(d) of the instant claim.
Regarding claim 30: Following the discussion of claims 22, 28, and 29 above, claim 4 of Shin discloses limitations a)-c) which anticipate limitations (a)-(c) of the instant claim.
Regarding claim 31: Following the discussion of claims 22, 28, 29, and 30 above, claim 5 of Shin discloses limitations a)-f) which anticipate limitations (a)-(f) of the instant claim.
Regarding claim 32: Following the discussion of claims 22, 28, and 29 above, claim 6 of Shin discloses limitations (i)-(vi) which anticipate limitations (i)-(vi) of the instant claim.
Regarding claim 33-34: Following the discussion of claims 22 and 28 above, claims 7-8 of Shin discloses the limitations of claims 33-34 of the instant application and thus anticipate the instant claims.
Regarding claim 35: Following the discussion of claims 22, 28, and 33-34 above, claim 9 of Shin discloses limitations (i)-(iv) which anticipate limitations (i)-(iv) of the instant claim.
Regarding claim 36: Following the discussion of claim 22 above, claim 10 of Shin discloses isolating the induced myeloid suppressive cells… or one or more subtypes thereof which anticipates limitation (1) of the instant claim.
Regarding claim 37: Following the discussion of claim 22 above, claim 1 of Shin discloses producing induced myeloid suppressive cells that are CD45+ an CD33+ and thus anticipates the instant claim.
Regarding claim 38: Following the discussion of claims 22 and 37 above, claim 1 of Shin discloses the medium composition comprises GMCSF and thus anticipates the instant claim.
Regarding claim 39: Following the discussion of claims 22, 37, and 38 above, claim 11 of shin discloses the medium composition further comprises one or more of VEGF, bFGF, SCF, IL3, FLT3L, and an AhR antagonist and thus anticipates the instant claim.
Regarding claim 40: Following the discussion of claims 22 and 37-39 above, claim 12 of Shin discloses the medium composition comprise the ROCK inhibitor, MCSF, VEGF, bFGF, SCF, IL3, FLT3L, GMCSF, and the AhR antagonist and thus anticipates the instant claim.
Regarding claim 40: Following the discussion of claim 22 above, claim 1 of Shin
discloses the method of steps (i)-(ii) produced a population of induced myeloid suppressive cells with enhanced therapeutic potential, claim 2k) of Shin discloses the induced myeloid derived suppressor cells (MDSCs) produced by the method of claim 1 of Shin have improved potency in suppressing T cell proliferation and effector function and ability in attenuating GvHD. Thus, while Shin does not teach a step of administering myeloid suppressive cells, it would have been prima facie obvious to a person of ordinary skill in the art to administer the MDSCs of Shin which have enhanced therapeutic potential and ability to attenuate GvHD to a human subject having GvHD. There is a reasonable expectation of success because The MDSCs of Shin have enhanced therapeutic potential and an ability to attenuate GvHD.
Claims 22, 23, and 25-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of Shin (U.S. Patent No. 11,851,677) in view of Chen (WO2012054747A2). Although the claims at issue are not identical, they are not patentably distinct for the following reasons:
Shin anticipates claims 22, 23, and 26-341 of the instant application.
Regarding claims 25: Following the discussion of claim 22 above, Shin anticipates limitations (a) and (b) of the instant application. Shin further discloses producing MDSCs that are CD45+ in claim 22.
Shin does not disclose treating a subject having an autoimmune disorder, a hematological malignancy, a solid tumor, cancer, an infection, a neurodegenerative disease, or an inflammatory condition or disease.
Chen discloses a composition and methods for treating tumors using isolated MDSCs in combination with oncolytic viruses, nanoparticles, or other anti-tumor agents (See abstract). The composition can be used to treat solid tumors (See ¶00107). In Example 6, Chen discloses a series of experiments in which CD45.1+ MDSCs are used for adoptive transfer to mice carrying hepatic tumors (See¶00170).
Given that Shin discloses producing MDSCs that are CD45+ and Chen discloses CD45+ MDSCs can be used to treat solid tumors, it would have been prima facie obvious to use the CD45+ MDSCs of Shin et al to treat a subject with a solid tumor. One would have been motivated to use the CD45+ MDSCs of Shin because Chen discloses CD45+ MDSCs can be used for adoptive transfer to treat a solid tumor. There is a reasonable expectation of success because Chen teaches CD45+ MDSCs can be used to treat solid tumors.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22-23 and 25-40 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 22 is drawn to a method of treating a subject. However, the method only requires differentiating iHE cells to MDSCs and providing a therapeutically sufficient number of the MDSCs. The claim does not require an active step of administering the MDSCs to a subject. It is unclear how providing a population of cells can treat a subject without an active step of administering the cells. Claims 23 and 25-40 depend from claim 22 and do not include an active step of administering the MDSCs. Thus claims 23 and 25-40 inherit the deficiency.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARISOL A O'NEILL whose telephone number is (571)272-2490. The examiner can normally be reached Monday - Friday 7:30 - 5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARISOL ANN O'NEILL/ Examiner, Art Unit 1633
/ALLISON M FOX/ Primary Examiner, Art Unit 1633
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