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 .
Applicant’s amendment and remarks filed on 2/16/2026 are acknowledged. Claims 1, 5-9, 11-12, and 17 are amended. Claims 15-16 and 18 are cancelled. Claims 1-14 and 17 are pending and are currently under examination.
Information Disclosure Statement
The information disclosure statements filed on 9/18/2025, 10/23/2025, 12/05/2025, 1/19/2026, and 2/24/2026 have been considered. Signed copies are enclosed.
Objections Withdrawn
The objection to the disclosure because it contains an embedded hyperlink and/or other form of browser-executable code is withdrawn in light of applicant’s amendment thereto.
Claim Rejections Withdrawn
The rejection of claims 1-15 and 17 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of applicant’s amendment thereto.
The rejection of claims 12-18 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the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention is withdrawn in light of applicant’s amendment thereto.
The rejection of claim 18 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn. The cancellation of the claim renders the rejection moot.
The rejection of claims 15-16 and 18 on the ground of nonstatutory double patenting as being unpatentable over claims 52-71 of copending Application No. 17789327 (reference application) is withdrawn. The cancellation of the claims renders the rejection moot.
The rejection of claims 15-16 and 18 under 35 U.S.C. 102(a)(1) as being anticipated by Horii et al (Biol Pharm Bull 37(4) 642-647, 2014; IDS filed 12/26/2024) is withdrawn. The cancellation of the claims renders the rejection moot.
The rejection of claims 1-13, 15-16, and 18 under 35 U.S.C. 102(a)(1) as being anticipated by Sanderson et al (J Clin Oncol, 23:741-750, 2005) is withdrawn in light of applicant’s amendment thereto.
Claim Rejections 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.
The rejection of claims 1-13 on the ground of nonstatutory double patenting as being unpatentable over claims 52-71 of copending Application No. 17789327 (reference application) is maintained for the reasons set forth in the previous office action. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons.
The instant claims are drawn to methods of activating CXCL10 production, promoting infiltration of CD8 cells, and preventing or treating cancer by administering an immunoadjuvant to a subject. The copending claims are drawn to methods of treating or preventing cancer by administering an immune checkpoint inhibitor and an immunoadjuvant (extract Z). The copending claims are silent with respect to activation of CXCL10 and CD8 cells. However, if the invention works as applicant claims, the results of administering the same component to the same population would necessarily have the same results. Therefore, the copending claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant argues: That the claims have been amended to specify that the claimed immunoadjuvant is a human Mycobacterium tuberculosis hot water extract (extract Z).
Applicant’s arguments have been fully considered and are not persuasive for the following reasons: The copending claims recite extract Z as the immunoadjuvant.
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.
The rejection of claims 1-12 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Horii et al (Biol Pharm Bull 37(4) 642-647, 2014; IDS filed 12/26/2024) is maintained for the reasons set forth in the previous office action.
The instant claims are drawn to methods of activating CXCL10 production, promoting infiltration of CD8 cells, and preventing or treating cancer by administering an immunoadjuvant to a subject.
Horii et al disclose methods of treating (and preventing) melanoma patients with Z-100 combined with radiation therapy (see page 643). Z100 is a mycobacterium hot water extract. The reference is silent with respect to activation of CXCL10 and CD8 cells. However, if the invention works as applicant claims, the results of administering the same component to the same population would necessarily have the same results. It is noted that the instant claims do not define “Extract Z.” Therefore, the mycobacterium hot water extract Z100 appears to be the same as Extract Z.
Applicant argues: That the claims emphasize CXCL10 activation, CD8+ T cell infiltration, and applicability to TMB-high/CD8-low tumors. Applicant argues that Horii et al does not disclose any comparable activation of CXCL10, CXCR3+ infiltration or any specific patient groups.
Applicant’s arguments have been fully considered and are not persuasive for the following reasons:
First, the rejected claims do not have any mention of TMB-high/CD8-low tumors. Therefore, arguments to that effect are not relevant.
Second, recognition of the effects on CXCL10, CD8+ T cells, and CXCR3 infiltration does not alter whether said effects occur. When one administers a composition, the effects of said administration will occur whether one desires or recognizes those effects. Therefore, if the claimed administration works as applicant asserts, the administration of Z100 necessarily activates CXCL10 and promotes infiltration of CXCR3 positive cells and CD8 positive T cells.
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 1-14 and 17 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 pre-AIA the applicant regards as the invention. Claims not specifically mentioned below are included because they do not resolve the issue of the parent claim.
Claims 1, 5-9, 11, and 12 are rendered indefinite by the parenthetical reference to Extract Z. It is not clear if the parenthetical reference is meant to be a defining limitation or if it is simply exemplary. Exemplary language renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Furthermore, “Extract Z” is simply a name applicant has used. This name does not have a limiting definition set forth in the claims or the specification. Therefore it is not clear what the metes and bounds of Extract Z are.
Claim 17 is indefinite because the grammatical structure of the sentence does not make sense. Further, the claim requires the composition or combination medicament to comprise an immunoadjuvant. However, the parent claim already requires the presence of the immunoadjuvant Extract Z.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian J Gangle whose telephone number is (571)272-1181. The examiner can normally be reached M-F, 9-6:30.
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, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BRIAN GANGLE/ Primary Examiner, Art Unit 1645
Prosecution Insights