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 .
Detailed Action
This application is a national stage application of PCT/US2022/042094, filed August 30, 2022, which claims benefit of provisional application 63/238300, filed August 30, 2021. Claims 1-6, 8, 9, 12, 15-19, 21-23, 25, 28, 30-33 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted February 28, 2024 is acknowledged wherein claims 6, 8, 12, 15-19, 21, 23, 25, 28, and 33 are amended.
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 30 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 30, which depends form claim 21, has as its sole additional limitation that the linker is either releasable or non-releasable. Since any linker bust be one or the other of these options, this limitation does not further limit claim 30. 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.
Claims 21, 22, 30, 31, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taik et al. (Foreign patent publication KR2021-0100854, Reference and English machine translation included with PTO-892)
Independent claim 21 is directed to a compound which is described as having a structure of formula (II) which is an imidazoquinoline attached to a group Z which is further defined as L-G, wherein L is a generic linker and G is a generic targeting moiety. Taik et al. discloses an imidazoquinoline conjugate which anticipates an embodiment of formula (II) wherein L is a carbamate and G is cholesterol, anticipating claim 21. (p. 10 paragraph 42) Regarding claim 22, the positions corresponding to X1, X2, and X3 in this structure are all N. Regarding claim 30, as discussed under 112(d) this claim does not further limit claim 21 and is therefore also anticipated. Regarding claim 31, the linker in this structure is a carbamate. Regarding claim 33, examples 3.1-3.4 on p. 14 of Taik describe pharmaceutical compositions comprising this compound in various carriers.
Therefore Taik et al. anticipates the present claims.
Claims 1-5, 15-19, 21, 22, and 30-33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Low et al. (PCT international publication WO2022/147576, Reference included with PTO-892)
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Independent claim 21 is directed to a compound which is described as having a structure of formula (II) which is an imidazoquinoline attached to a group Z which is further defined as L-G, wherein L is a generic linker and G is a generic targeting moiety. Independent claim 33 is directed to a pharmaceutical composition comprising this conjugate and a carrier. Independent claim 1 is directed to a method of treatment comprising administering this composition to a subject who has previously received combination with either a vector or T-cells encoding CAR, and a cancer binding conjugate ligand.
Low et al. discloses a combination cancer therapy comprising engineered CAR-T cells and a drug composition comprising a folate receptor binding ligand and a TLR agonist. (p. 2 paragraph 10 – p. 3 paragraph 12) In one embodiment the cell is a CAR-expressing cytotoxic lymphocyte, or T Cell. (p. 3 paragraph 13) The compound is a TLR agonist having the same structure (Formula 2-I on p. 4) as formula (I) in present claims 1, 21, and 33. This conjugate therefore anticipates claim 21. Furthermore regarding claim 33, paragraph 53 of Low et al. discloses the composition as comprising one or more pharmaceutically acceptable carriers. Regarding claim 1, carrying out a therapeutic method as described by Low for an extended period of time would infringe this method, as it would involve administering the same conjugate recited in claim 1 to a subject who had been previously treated with a combination of a CAR-expressing cytotoxic lymphocyte and a TLR agonist containing conjugate, anticipating claim 1.
Regarding claims 2-5, 15-19, 22, 31, and 32, the specific structural embodiments recited in p. 96 paragraphs 297 and 298 of Low infringes these claims.
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, 15-19, 21, 22, and 30-33 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of copending Application No. 18/260273 (reference application, US pre-grant publication 2025/0269036, cited in PTO-892, herein referred to as ‘273). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘273 anticipate the present claims.
Independent claims 1 and 2 of ‘273 are directed to a process comparing administering to a subject a conjugate comprising a TLR 7 or 8 ligand and a folate ligand, in combination with an engineered cell. Dependent claim 3 further specifies that the engineered cell can include a CAR T-cell therapy. Still further, claims 5-6 of ‘273 specify that the conjugate has a structure that falls within the scope recited in claims 1-5, 15-19, 21, 22, and 31-33. Therefore compositions comprising this compound would infringe claims 21, 22, and 31-33, and methods wherein the combination therapy was administered over an extended period of time would infringe claims 1-5 and 15-19.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-5, 15-19, 21, 22, and 30-33 are rejected. Claims 6, 8, 9, 12, 23, 25, and 28 are objected to for depending from a rejected base claims but would be allowable if rewritten in independent form incorporating all of the limitations of the rejected base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA OLSON whose telephone number is (571)272-9051. The examiner can normally be reached M-F 6am-3:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREA OLSON/Primary Examiner, Art Unit 1693 7/24/2026
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