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 .
Examiner Reassignment
The present Application has been reassigned to Examiner Robert M. Kelly, Ph.D. The Examiner’s information, along with his SPE, is located at the end of this action. Please address future correspondence accordingly.
Applicant’s amendment and argument of 4/6/26 is entered.
The amendment is a restatement of the claims previously of record.
Claims 1, 5-7, 10-15, 36-37, and 41-44 are pending.
Priority
The Examiner has reviewed priority, and agrees to the priority chain, provided here:
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Further, it is argued that 17/122,521 (Pat 11,925,662) is a CON of 15/756473, and thus, not protected by the safe harbor of the restriction in the 15/756,473 Application, as it was not caused to be filed due to the restriction therein.
Further, the 15/756,473 Application has been abandoned, so there is no reason to address any NSDP rejections therein.
Finally, it is agreed that the present Application may be protected by the safe harbor due to the restriction requirement in 15/576,473 (as long as other groups are not rejoined during current prosecution) as it is a CON derived from the chain beginning with restriction in the 15/576,473 Application.
Applicant’s argument is that the present Application is a DIV and elects one of the five groups restricted in 15/576,473, that they meet the inventorship and reference to earlier Application requirements, and the instant application was filed before patenting of the parent case. Thus, Applicant argues the invention is protected, and withdrawal of the rejection is requested. Pp. 1-2 of the Argument of 4/6/26.
In response to the same, the present Examiner agrees with everything, except that the patent evolved from the CON of the 15/576,473 Application, and thus, as it was not caused to be filed by the restriction in the 15/576,473 Application, the 11,925,662 patent is not protected by the restriction in such 15/576,473 Application. Applicant’s resolution would be to amend the priority of the 17/122,521 Application to being a DIV of the 15/576,473 Application.
Claim Interpretation
The present Examiner agrees with the claim interpretation previously provided, so it will remain here:
Claim 36 recites the term "canonical neutrophil associated molecules", as well as the term "canonical tumor-associated neutrophil (TAN)".
An American English dictionary definition of the word 'canonical' is: the standard, rule or primary source that is accepted as authoritative for the body of knowledge or literature in that context.
Claim 36 describes, then, that the molecules which are expressed by those white blood cells (leukocytes) which would be considered to be conventional or typical neutrophils are Arg1, MPO, CD66b and CD15. The specification describes canonical TANs as expressing the molecules CD11b+CD66b*CD15 (clean copy specification filed 22 May2024, pg. 9, lines 7-9). Therefore, it appears as though tumor associated neutrophils not only express Arg1, MPO, CD66b and CD15 (so-called conventional or typical neutrophil cell markers), but also CD11b+.
One of ordinary skill in the art of immunology and leukocyte cell discrimination would understand that neutrophils have the potential to express other cell surface (or intracellular) molecules that are not described in the instant claims or specification (but which would be considered to be 'canonical'), depending on the biophysiological or biochemical milieu in which the cells are located. However, for the purpose of compact prosecution, the claims will be interpreted to read
Claim 36: “…, wherein the hybrid neutrophil co-expresses the neutrophil associated molecules..., and the antigen presenting cell (APC) associated molecules..."; and " , wherein the expression of any one of the molecules is increased relative to expression of the molecule on a tumor associated neutrophil (TAN)."
In addition, prior art which shows increased expression of molecules on a TAN which are not CD11b, CD66b or CD15 will be considered to be showing an increased level of any one of the molecules cited in claim 36 relative to a canonical TAN.
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.
The present rejection is the same, but rewritten for clarity and brevity.
Claims 36-37 and 41-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,925,662. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 36: Patent Claim 1 teaches administering human hybrid neutrophils, where they express neutrophil associated molecules including Arg1, MPO, CD66b, CD15 as well as expressing APC associated molecules CD14, HLA-DR, CD32, CD64, and CD89. Claim 16 also teaches administration of the same human hybrid neutrophils expressing the same molecules as Claim 1. The depending claims necessarily also necessarily contain the same administrations.
Claim 37: Claim 2 of the patent requires the same neutrophils to express MHC class I and MHC class II, OX40L, 4-1BBL, CD86, CD40, and CCR7.
Claim 41: Claim 2 of the patent requires the same neutrophils to express MHC class I and MHC class II, OX40L, 4-1BBL, CD86, CD40, and CCR7. Also, Claim 4 teaches MHC class I, OX40L, 4-1BBL, CD86, CD40 and CCR7.
Claim 42: Claim 5 is to embodiments where, e.g., CD32, CD64, CD89 is increased relative to that found on a canonical neutrophil.
Thus, in light of the patent is obvious. The Artisan would make the invention, in the process of performing the methods of the patent. The Artisan would expect success, as the methods are claimed by the patent.
Further, it is the Examiner’s stance that the patent is not protected by safe harbor provisions due to the restriction in the parent Application, Application No. 15/756,473, as the Application that evolved into the Patent was a continuation of the 15/756,473 Application, and thus, it was not caused to be filed due to the restriction in the parent case.
Response to Argument – NSDP rejections, 11,925,662 Patent
Applicant’s argument of 4/6/26 has been considered but is not found persuasive.
Applicant’s argument is that the present Application is a DIV and elects one of the five groups restricted in 15/576,473, that they meet the inventorship and reference to earlier Application requirements, and the instant application was filed before patenting of the parent case. Thus, Applicant argues the invention is protected, and withdrawal of the rejection is requested. Pp. 1-2 of the Argument of 4/6/26.
In response to the same, the present Examiner agrees with everything, except that the patent evolved from a CON of the 15/576,473 Application, and thus, as it was not caused to be filed by the restriction in the 15/576,473 Application. Therefore, the 11,925,662 patent is not protected by the restriction in such 15/576,473 Application. Applicant’s resolution appears to be to amend the priority of the 17/122,521 Application to being a DIV of the 15/576,473 Application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
In light of the argument, the rejections of Claim(s) 36-37 and 42 under 35 U.S.C. 103 as being unpatentable over Takashima et al. ((2015 Jan.) J. Leukoc. Biol. 98: 489-496) in view of Glasser ((1977) Blood 50(6): 1145-1150), Amsalem et al. ((2014) J. Immunol. 193: 3070-3079), Matsushima et al. ((2013) Blood 121(10): 1677 1689), Edberg et al. ((1998) J. Biol. Chem. 237(14): 8071-8079), and Scapini et al. ((2014) Blood 124(5): 710-719), are withdrawn.
In light of the argument, the rejections of Claim(s) 41 under 35 U.S.C. 103 as being unpatentable over Takashima et al. in view of Glasser, Amsalem et al., Matsushima et al., Edberg et al., and Scapini et al., as applied to claims 36, 37 and 42 above, and further in view of Fridlender et al. ((2012) Carcinogen. 33(5): 949-955), Croft et al. ((2009) Immunol. Rev. 229: 173-191), Kwon ((2009) Immune Network 9(3): 84-89), and Beauvillain et al. ((2011) Blood 117(4): 1196-1204), are withdrawn.
To wit, the present Examiner accepts Applicant’s arguments that there is no comprehensive showing that conditions can be provided to arrive at cells with all the markers reasonably predicted to be present, on a neutrophil. While the evidence is limited in the art, to those markers particularly looked-for, in each piece of art, and while they do not exclude the possibility of arriving at the particular combination of markers presently claimed, it would be hindsight to arrive at these, and there is no reasonable expectation of success that they would be arrived at, given the disparate showings of distinct markers and no comprehensive showing for all marker types.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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