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 .
This office action is in response to an amendment filed 7/21/2025.
Claims 16-35 are pending.
This application is continuation of International Application No. PCT/US2021/018868 filed February 19, 2021, which claims the benefit of U.S. Provisional Application Nos.: 62/979,309 filed February 20, 2020; 63/044,597 filed June 26, 2020; and 63/136,134 filed January 11, 2021.
Election/Restrictions
Applicant's election without traverse of Group I, claims 16-31 and 35, drawn to a chimeric inhibitory receptor comprising: (a) an extracellular protein binding domain, (b) a transmembrane domain, wherein the transmembrane domain is operably linked to the extracellular protein binding domain, wherein the transmembrane domain is selected from the group consisting of BTLA, CD8, CD3zeta, CD4, 4-IBB, 0X40, ICOS, 2B4, CD25, CD7, LAX, LAT, PD-1, CTLA4, TIM3, KIR3DL1, LIRI, NKG2A, TIGIT, and LAG3, (c) one or more intracellular signaling domains, wherein the one or more intracellular signaling domains are operably linked to the transmembrane domain; wherein each of the one or more intracellular signaling domains is derived from a protein selected from the group consisting of: BTLA, PD-1, CTLA4, TIM3, KIR3DL1, LIR1, NKG2A, TIGIT, and LAG3, vectors and host cells comprising the cassette and a method of producing the recombinant host cell in the reply filed on 7/21/2025is acknowledged. has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 32-34 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
Because applicants have elected Group I, the amendment to correct the claim disposition for each claim is that Group I is claims 16-31 and 35. Since, these were listed in error, the restriction is non-final. To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code in bridging ¶ pages 35-36. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites a number of listed proteins that are not transmembrane domains. Rather, the claim should recite that “the transmembrane domain is from a protein selected from the group”
Appropriate correction is required.
Claim Rejections - 35 USC § 112, second paragraph
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.
Claim 16 is vague and indefinite in that the metes and bounds of the term “derived from” are unclear. It is unclear the nature and number of steps required to obtained a “derivative” of the claimed proteins. The term implies a number of different steps that may or may not result in a change in the functional characteristics of the intracellular signaling domain from the source that it is “derived from”. This same issue exists for claim 18 wherein the domain is “derived from” LIR1. The term implies a number of different steps that may or may not result in a change in the functional characteristics of the intracellular signaling domain from the source that it is “derived from”. This is true of claims 18, 20, 24,27 and 35
Claim 17 is vague in reciting “same”. The term “same” is a relative one not defined by the claim, no single set of conditions is recognized by the art as being “same” and because the specification does not provide a standard for ascertaining the requisite degree, the metes and bounds of this claim cannot be established. There are a number of proteins and it is unclear to which the reference is being made. This is true of claim 35, last line.
Claim Rejections - 35 USC § 102
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 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 16, 17, 22, 23, 25, 26, 28-31 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Federov and Sadelain (US 20150376296).
Federov and Sadelain teach an iCAR (abstract) that comprises one of PD-1, BTLA, LAG2 or CTLA4 transmembrane and intracellular domains. As the components meet the limitations of the claims and as well are taught to inhibit and prevent CAR signaling (¶ 0025).
The antigen bound by the iCAR is not found on the tumor cell (see e.g. ¶0110).
The iCAR is comprised in immunomodulatory cells such as cytotoxic T cells (abstract).
The iCAR is encoded by a nucleic acid that is part of a vector and pharmaceutical composition (see ¶ 0012, 0015, 0016).
Claims 16, 17, 18, 22, 23, 25, 26, 28-31 and 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gross et al (US 20200261499).
Gross et al teach an iCAR (abstract) that comprises one of i.e. PD-1 transmembrane and intracellular domains (see ¶0718). As the components meet the limitations of the claims and as well are taught to inhibit and prevent CAR signaling (abstract).
The antigen bound by the iCAR is not found on the tumor cell (see e.g. ¶0016).
The iCAR is comprised in immunomodulatory cells such as cytotoxic T cells (abstract).
The iCAR is encoded by a nucleic acid that is part of a vector and pharmaceutical composition (see abstract ¶ 0137).
The iCAR comprises at least one signal transduction element that can be LIR1 (see ¶0217).
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 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.
Claims 16-31 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Federov and Sadelain (US 20150376296) or Gross et al (US 20200261499) in view of Bonyhadi et al (US 20200297760) and Saxon et al (US 20030082190) and Cosman et al (US 6,448,035) .
While Gross et al does not teach that the transmembrane domains are not from LIR-1, LIR-1 is a transmembrane protein (Saxon et al, ¶0017) comprising a signal transduction domain and in addition to the signal transduction domain could be used as a replacement for PD-1 for the same function.The sequence was known for LIR-1 TM and ISD,
RESULT 36
US-08-842-248A-2
(NOTE: this sequence has 12 duplicates in the database searched.
See complete list at the end of this report)
Sequence 2, US/08842248A
Patent No. 6448035
GENERAL INFORMATION
APPLICANT: Cosman, David J.
TITLE OF INVENTION: Family of Immunoregulators Designated
TITLE OF INVENTION: Leukocyte Immunoglobulin-Like Receptors (LIR)
CURRENT APPLICATION NUMBER: US/08/842,248A
CURRENT FILING DATE: April 24, 1997
NUMBER OF SEQ ID NOS: 29
SEQ ID NO 2
LENGTH: 650
TYPE: PRT
Query Match 100.0%; Score 88; Length 650;
Best Local Similarity 100.0%;
Matches 21; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 VIGILVAVILLLLLLLLLFLI 21
|||||||||||||||||||||
Db 462 VIGILVAVILLLLLLLLLFLI 482
RESULT 44
US-08-842-248A-2
(NOTE: this sequence has 12 duplicates in the database searched.
See complete list at the end of this report)
Sequence 2, US/08842248A
Patent No. 6448035
GENERAL INFORMATION
APPLICANT: Cosman, David J.
TITLE OF INVENTION: Family of Immunoregulators Designated
TITLE OF INVENTION: Leukocyte Immunoglobulin-Like Receptors (LIR)
CURRENT APPLICATION NUMBER: US/08/842,248A
CURRENT FILING DATE: April 24, 1997
NUMBER OF SEQ ID NOS: 29
SEQ ID NO 2
LENGTH: 650
TYPE: PRT
Query Match 99.6%; Score 886; Length 650;
Best Local Similarity 99.4%;
Matches 167; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 LRHRRQGKHWTSTQRKADFQHPAGAVGPEPTDRGLQWRSSPAADAQEENLYAAVKHTQPE 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 483 LRHRRQGKHWTSTQRKADFQHPAGAVGPEPTDRGLQWRSSPAADAQEENLYAAVKHTQPE 542
Qy 61 DGVEMDTRSPHDEDPQAVTYAEVKHSRPRREMASPPSPLSGEFLDTKDRQAEEDRQMDTE 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 543 DGVEMDTRSPHDEDPQAVTYAEVKHSRPRREMASPPSPLSGEFLDTKDRQAEEDRQMDTE 602
Qy 121 AAASEAPQDVTYAQLHSLTLRREATEPPPSQEGPSPAVPSIYATLAIH 168
||||||||||||||||||||||:|||||||||||||||||||||||||
Db 603 AAASEAPQDVTYAQLHSLTLRRKATEPPPSQEGPSPAVPSIYATLAIH 650
Spacers are included in the compositions of Gross et al and Federov and Sadelain but not specified. However, the art teaches spacers comprising IgG1 (see Bonyhadi e.g. ¶0222).
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the known sequences used for similar compositions in the iCARs of Gross et al and Federov and Sadelain. Such a modification would have resulted in a inhibitory receptor of claims 18-21 and 24. As noted above: 1) Gross and Federov teach inhibitory receptors that prevent immunomodulatory cell activity and these compositions comprise components from inhibitory receptors; 2) Saxon teaches that LIR-1 is such an inhibitory receptor and is a transmembrane receptor, 3) Cosman teaches the sequence of this receptor and 4) known spacers are taught by Bonyhadi. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded method would allow improved treatment.
Double Patenting
A rejection based on double patenting of the "same invention" type finds its support in the language of 35 U.S.C. 101 which states that "whoever invents or discovers any new and useful process ... may obtain a patent therefor ..." (Emphasis added). Thus, the term "same invention," in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957); and In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970).
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. See 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);and, 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 16, 17, 20-31 and 35 are provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1, 3-5 and 7-20 of copending Application No. 17/636,301.
An obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but an examined application claim is not patentably distinct from the reference claims because the examined claim is either anticipated by, or would have been obvious over, the reference claims. Although the conflicting claims are not identical, they are not patentably distinct from each other because the cited claims of the instant invention are generic to all that is recited in claims 1, 3-5 and 7-20. That is, the cited claims of copending Application No. 17/636,301 anticipate and fall entirely within the scope of the rejected claims of the instant application. The copending claims requite the same extracellular binding domain that can be an antigen binding domain (see copending claim 4), the same transmembrane domains (see copending claim 7) as well as the same intracellular signaling domains (see copending claim 8). It is noted that instant claim 21 reading on LIR1 transmembrane domain is encompassed by copending claim 7. The spacer in claim 24 overlaps that in claims 10 (see SEQ ID NO:46).
Additionally, if a patent resulting from the instant claims was issued and transferred to an assignee different from the assignee holding the copending Application No. 17/636,301, then two different assignees would hold a patent to the claimed invention of copending Application No. 17/636,301, and thus improperly there would be possible harassment by multiple assignees.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
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/MARIA MARVICH/Primary Examiner, Art Unit 1634