DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Please note that the examiner of record for your application has changed. To aid in paper matching, please address all future correspondence to Michael Szperka, Art Unit 1641, Technology Center 1600.
Applicant’s response and amendments received November 24, 2025 are acknowledged.
Claims 2, 7, 8, 13-15, 20-22, 24-58, and 61 have been canceled.
Claim 1 has been amended.
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 are pending.
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 are under examination in this office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/24/2025 is acknowledged and the references cited therein have bene considered.
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.
The rejection of claim 61 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been rendered moot in view of the cancelation of said claim as part of the November 24, 2025 response.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claim under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement concerning new matter has been withdrawn in view of the cancelation of said claim as part of the November 24, 2025 response.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected under 35 U.S.C. 103 as being unpatentable over Lim (US2016/0264665, published 09/15/2016, of record) in view of Raum (US2017/0029512, published 02/02/2017, of record), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010, of record), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009, of record).
Examiner’s Response to Traversal: Applicant argues on many grounds as part of the response received November 24, 2025. Applicant begins by citing case law not directly tied into what has been presently claimed or argued. Applicant next argues that elements of the claimed invention are missing in the prior art teachings, specifically that Figure 12 of Lim shows antigens A and B on the same cell while the instant claimed invention requires antigens A and B to be on different cells, that the cited art has no reasonable expectation of success and in applicant’s opinion teaches away from the claimed invention, and that the secondary references fail to remedy the deficiencies of Lim et al.
These arguments have been carefully considered but are not found persuasive.
With regard to the cited case law, applicant appears to have cited it without connecting it to the instant case and thus this incomplete argument is not persuasive. With regard to applicant’s contention Lim’s Figure 12 does not teach claim 1 as Figure 12 contains antigens A and B on the same cell while claim 1 requires A and be to be on different cells (i.e. in trans), applicant is respectfully reminded that the instant claims stand rejected as obvious in view of Lim and addition teachings as compared to being anticipated by Lim. As set forth in prior office actions, immune cell(s) only carrying the BTTS system were discussed as set forth in the rejection of record in the 10/07/2024 office action. While Figure 12 of Lim shows A and B in the same cell, it would be readily apparent to artisans that they do not have to be, a fact explicitly set forth in Figure 15 of Lim, reproduced below for applicant’s convenience, show the following:
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Given the fact that Lim teach the ligand antigens need not be on the same cell, applicant’s insistence that it would not have been obvious to an ordinary artisan that the antigens could be on separate cells is highly unpersuasive. With regard to teaching away, applicant argues very specific data from a particular model system which by applicant’s own arguments is not the claimed invention (otherwise Lim would necessarily anticipate that which is claimed) as to why artisans would be dissuaded from having priming and targeting ligand antigens being expressed on different cells, is also not persuasive as the limitations of the data argued by applicant are not present in the generic invention as presently claimed by applicant (and thus applicant is arguing limitations not claimed) and because contrary to applicant’s assertions having a priming and targeting antigens on separate cells is obvious and disclosed by the cited art. It should be noted that artisans in this field are extremely creative and educated, often having one or more advanced degrees including Ph.D. and M.D. and thus their ability to envisage modifications to the art via combining different sources is much, much more adept than that argued by applicant wherein artisans are prisoners of what is taught by a single reference. Indeed, the courts have long ruled that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In view of all of the above the rejection of record is maintained.
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.
Examiner’s Response to Traversal: Applicant argues as part of the November 24, 2025 response that none of the issued patents teach the claimed subject matter, and that the cited references fail to rectify the alleged deficiencies, and repeats arguments set forth with the obviousness rejection under 35 USC 103,
Such arguments have been considered and are not persuasive. As set forth in the rejections of record, artisans would see the instant claimed inventions as obvious variations of that which was previously patented when seen in combination with the cited prior art. See also the arguments concerning obviousness under 35 USC 103 above. Thus, all rejections below are maintained.
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10590182 in view of Lim (US2016/0264665, published 09/15/2016), Raum (US2017/0029512, published 02/02/2017), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009).
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9670281 in view of Lim (US2016/0264665, published 09/15/2016), Raum (US2017/0029512, published 02/02/2017), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009).
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9834608 in view of Lim (US2016/0264665, published 09/15/2016), Raum (US2017/0029512, published 02/02/2017), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009).
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10836808 in view of Lim (US2016/0264665, published 09/15/2016), Raum (US2017/0029512, published 02/02/2017), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009).
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10822387 in view of Lim (US2016/0264665, published 09/15/2016), Raum (US2017/0029512, published 02/02/2017), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009).
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 12090170 in view of Lim (US2016/0264665, published 09/15/2016), Raum (US2017/0029512, published 02/02/2017), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009).
Claims 1, 3-6, 9-12, 16-19, 23, 59, 60, and 62 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. patent 12144826 (previously Application No. 17/042030) in view of Lim (US2016/0264665, published 09/15/2016), Raum (US2017/0029512, published 02/02/2017), Inda (Genes and Development, Vol. 24, Pg. 1731-1745, 2010), and Jeuken (Brain Pathology, Vol. 19, Pg. 661-671, 2009).
No claims are allowable.
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 Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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