DETAILED ACTION
Applicant’s amendment and remarks filed January 16, 2026 are acknowledged and entered. Any prior objection or rejection that is not repeated or addressed below is either moot or withdrawn in view of Applicant’s amendment.
The elected species are: chronic inflammatory disease, disease characterized by chronic inflammation, autoimmune disease (various diseases recited in claims 11, 76 and 79), and therapeutic antibody. Claim 16 and new claim 80 are withdrawn from consideration being directed to non-elected subject matter.
Claims Summary
Claims 1, 11, 20, 21, 26-29, 31, 45, 46, 50, 51 and 75
Claim 1 is directed to a method for treating, in a subject in need thereof, chronic inflammatory disease, such as arthritis (claim 11), or a disease characterized by chronic inflammation, wherein the disease is not a cancer. The method comprises administering to the subject an attenuated poxvirus, such as vaccinia (claim 20, e.g., MVA (claim 21)) and a stem cell. The poxvirus and/or the stem cell comprises a recombinant polynucleotide encoding a therapeutic molecule (claims 1, 26 and 27) that treats the disease (claims 28), wherein the therapeutic molecule is a therapeutic antibody (claims 29 and 75). The subject is a human (claim 50) or a domesticated animal (claim 51). The method further comprises administering a therapeutic agent (claim 31).
The poxvirus and/or the stem cell are administered by, for example, an intravenous route (claim 45). The poxvirus and/or the stem cell are administered directly to a region affected by the disease (claim 46). Please note that claims 45 and 46 are dependent on canceled claim 9, but will be treated as if dependent on claim 1 for purposes of compact prosecution.
Claims 3 and 76-78
Claim 3 is directed to a method for converting chronic inflammation into acute inflammation by administering to a subject an attenuated poxvirus and a stem cell, wherein the chronic inflammation is not a cancer, such as arthritis (claim 76). The stem cell or the poxvirus comprises a recombinant polynucleotide encoding a therapeutic molecule (claims 77 and 78).
Claims 8, 79, 81 and 82
Claim 8 is directed to a method for treating chronic inflammatory disease in a subject having cancer by administering an attenuated poxvirus and a stem cell, wherein the chronic inflammation is, for example, arthritis (claim 79). The stem cell or the poxvirus comprises a recombinant polynucleotide encoding a therapeutic molecule (claims 81 and 82).
Claim Objections
Claims 11, 21, 76 and 79 are objected to because of the following informalities:
Claims 11, 76 and 79 :
Glomerulonephritis is misspelled
Atherosclerosis appears to be recited three times, and misspelled at the second instance
Arthritis appears to be recited twice
Periodontitis appears to be recited twice
Claim 21 recites “Tian Tan” twice. In the remarks filed 01/16/2026 Applicant indicates that claim 21 is amended to correct the informality, but no amendment appears to have been made. Appropriate correction is required.
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.
(New Rejection) Claims 45 and 46 are 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. Claims 45 and 46 are dependent on canceled claim 9. The metes and bounds of the claims cannot be determined.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 8, 11, 20, 21, 26-29, 31, 45, 46, 50, 51 and 75 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stritzker et al. (US 2009/0180987 A1, cited in the IDS filed 3/1/2022, “Stritzker”). The claims are summarized above and correlated with the teachings of the prior art in bold font below.
Stritzker discloses methods and compositions for treating inflammatory disease, such as autoimmune disease, e.g., arthritis (see abstract and paragraph [0147]), by administering a vaccinia viral vector, such as Wyeth (see paragraph [0594]), wherein the vector contains nucleic acid that encodes a therapeutic composition (see paragraph [0223]) (claims 1, 3, 8, 11, 20, 21, 26-28, 77, 78, 81, 82). Stritzker also discloses the administration of cells, such as stem cells, expressing therapeutic agents (see paragraphs [0024] and [0223]) (claims 1, 3, 8, 26-28, 77, 78, 81, 82). In the abstract and paragraphs [0223], [0224], and [0232], Stritzker discloses poxvirus and stem cell combinations for therapy of diseases, disorders and conditions that are not limited to cancer (claims 1, 3 and 8). Therapeutic agents include antibodies (see paragraph [0040]) (claims 29 and 75). An additional therapeutic agent is administered (see paragraph [0012], last sentence) (claim 31). Stritzker discloses modes of administration including intravenous (claim 45), or at the target site (claim 46) (see Stritzker, paragraph [0690]. Subjects receiving the treatment include humans and domesticated animals (see paragraph [0162]), as well as those with cancer (see paragraph [0015]) (claims 8, 50 and 51). Therefore, the claims are anticipated by the prior art.
Applicant’s remarks filed January 16, 2026 have been carefully considered but fail to persuade. Applicant argues that the combination of poxvirus and stem cells is only taught in the context of treating cancer, pointing to the abstract and paragraphs [0124], [0665], [0699] and [0702]. Applicant also argues that poxvirus is only taught in the context of treating cancer, pointing to paragraphs [0234], [0288], [0366] and [0596], as well as Examples 9 and 10.
In response, in the abstract and paragraphs [0223], [0224], and [0232], Stritzker discloses poxvirus and stem cell combinations for therapy of diseases, disorders and conditions that are not limited to cancer. The abstract discloses methods of treating a disease, disorder or condition using microorganisms or cells, or combinations. Paragraph [0223] discloses methods of treating diseases and disorders using a microorganism or cell, or combinations. Paragraph [0224] discloses microorganisms or cells, or combinations for treating cancer, inflammation and infection. Paragraph [0232] discloses compositions/methods combined for therapy of proliferative sites and conditions, diseases, disorders and conditions. Therefore, Stritzker discloses combinations of microorganisms and cells for both cancer and non-cancer conditions, such as inflammation. The claims remain rejected for reasons of record.
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 1, 3, 8, 11, 20, 21, 26-29, 31, 45, 46, 50, 51, 75-79, 81 and 82 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20, 21 and 59-74 of copending Application No. 17/615,018 (reference application) in view of Stritzker et al. (US 2009/0180987 A1, cited in the IDS filed 3/1/2022, “Stritzker”). Although the claims at issue are not identical, they are not patentably distinct from each other. The copending claims are directed to a method for treating a disease characterized by chronic inflammation (copending claim 21) by administering a composition comprising a poxvirus and an induced pluripotent stem cell. Copending claims 64-74 are directed to embodiments of poxviruses, therapeutic molecules, therapeutic antibodies, etc., which render obvious the embodiments of the instant claims.
The copending claims do not specify autoimmune disease, routes of administration, or human and domesticated animal subjects. However, these embodiments would have been obvious to have claimed in view of Stritzker. Stritzker discloses methods and compositions for treating inflammatory disease, such as autoimmune disease, such as arthritis (see abstract and paragraph [0147]), by administering a vaccinia viral vector (see paragraph [0594]), wherein the vector contains nucleic acid that encodes a therapeutic composition (see paragraph [0223]). Stritzker discloses modes of administration including intravenous, or at the target site (see Stritzker, paragraph [0690]. Subjects receiving the treatment include humans and domesticated animals (see paragraph [0162]), as well as those with cancer (see paragraph [0015]). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In the remarks filed January 16, 2026, Applicant requests that this provisional rejection be held in abeyance until allowable subject matter is identified.
Conclusion
No claim is allowed.
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.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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