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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5, 7-12, in the reply filed on 06/29/2026 is acknowledged.
Election of species of immune checkpoint inhibitors is acknowledged.
Claims 9-16 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/29/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 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.
Claim 2 depends on claim 1 and adds functional limitation of formulation of claim 1 activity. Such functional limitation does not affect the structure of formulation of claim 1, but simply recites the way of activity of such formulation. Thus, claim 2 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-3, 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stanford et al (US 2019/0151428, May 2019).
Concerning claims 1-3, 7-8 Stanford disclose vaccine for treatment of cancer comprising poly(I:C) (see paragraphs [0009-0010]), which can further comprise lipopeptides such as Pam3Cys-SKKKK (instant SEQ ID NO: 1) (see paragraphs [0110, 0112]) and antibodies targeting PD-1 or PD-L1, immune checkpoint inhibitors (see paragraphs [0165, 0261]).
Claim Rejections - 35 USC § 103
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) 1-5, 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al (KR20140119362, October 2014, cited from IDS, citations are from machine translation) and in further view of Waele et al (Oncoimmunology, 2018, vol.7, no.3, e1407899: 1-15, cited from IDS).
Sun teach vaccine adjuvant comprising lipopeptide and poly(I:C) for cancer treatment (see page 3 of machine translation). The ratio of lipopeptide and poly(I:C) in an aqueous solution can be 1:1 and 2:1 (see page 4). The lipopeptide to use can be Pam3Cys-SKKKK (instant SEQ ID NO: 1) (see pages 4-5).
Sun do not teach inclusion of anti-PD-L1 antibodies in such vaccine.
Waele teach combination treatment of cancer (glioblastoma) with poly(I:C) and anti-PD-L1 antibody (see Abstract, page 11).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to add anti-PD-L1 antibody to a vaccine taught by Sun based on teachings of Waele arriving at instant invention. One of the ordinary skill in the art would be motivated to do so because both Sun and Waele teach compounds for cancer treatment, lipopeptide and poly(I:C) in case of Sun and poly(I:C) and anti-PD-L1 antibody in case of Waele, thus providing motivation to combine such compounds in one composition comprising lipopeptide, poly(I:C) and anti-PD-L1 antibody.
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 1-5, 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,216,595 in view of Waele, above. Claims from ‘595 teach vaccine adjuvant for treatment of cancer comprising Pam3Cys-SKKKK lipopeptide and poly(I:C). Claims do not recite further inclusion of anti-PD-L1 antibody into such vaccine. Teachings of Waele are discussed above. It would have been obvious to further include anti-PD-L1 antibody into vaccine of ‘595 to further improve such vaccine based on teachings of Waele.
Claims 1-5, 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,612,650 in view of Waele, above. Claims from ‘650 teach vaccine adjuvant comprising Pam3Cys-SKKKK lipopeptide and poly(I:C). Claims do not recite further inclusion of anti-PD-L1 antibody into such vaccine. Teachings of Waele are discussed above. It would have been obvious to further include anti-PD-L1 antibody into vaccine of ‘650 to further improve such vaccine based on teachings of Waele.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
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