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 reply to the Restriction Requirement, dated May 6, 2026, has been received. By means of this reply, Applicant has cancelled claims 1-132 and 134-179 and introduced new claims 180-194, and elected the species of treatment with an anti-TIGIT antibody, the species of CPA.9.086.H4(S241P) (SEQ ID NO: 877 heavy chain and SEQ ID NO: 882 light chain), and without additional treatment.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 133 and 180-194 are pending in the application.
Claim 186 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 6, 2026.
Claims 133, 180-185, and 187-194 are therefore under examination before the Office.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code at pages 31, 59, 72, 109, 185, 188, and 189. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections – Improper Markush
Claims 133, 180, 182-184, and 188-194 are rejected on the basis that the claim contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 133 is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: while all members of the group are antibodies that bind to the same protein (TIGIT), the claimed complimentary determining regions of the antibodies which give them the common function of binding to TIGIT are structurally distinct. Compare, for example, the sequences of the heavy chain CDR3 of CPA.9.018 (AKEMLVQDYYYMDV)(SEQ ID NO: 820) and the heavy chain CDR3 of CPA.9.057 (ARQGAAAGNPFDI)(SEQ ID NO: 820). While both are listed as being alternatives for the heavy chain complementary determining region 3, they are clearly structurally distinct. Using the above example, the various antibodies of the Markush group are patentably distinct from one another as prior art on one would not anticipate or render obvious any of the others.
There is also no indication in the art that each member of the Markush group will in the same way in the context of the claimed invention. The common use among the members of the Markush is the ability to bind TIGIT. It is the specific sequences of each complementarity determining region (CDR) that gives each antibody its ability to bind TIGIT, and here, that common use does not flow from a structural feature that is common to all members of the Markush. This is especially true as variations within the CDRs are within the scope of the claims, which may drastically alter the antibody's ability to bind its cognate antigen (see, e.g. Rudikoff, PNAS, vol. 79, no. 6, pp. 1979-1983, March 1982, cited in IDS), resulting in a Markush group that is vastly larger than just the recited antibodies.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Applicant is invited to present a consensus sequence common to all members of the Markush group in order to assist in addressing this rejection.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 133, 180-185, and 187-194 are rejected under 35 U.S.C. 103 as being unpatentable over White (US20180169238A1, cited in IDS as U.S. patent 10,124,061).
White teaches an anti-TIGIT antibody comprising a heavy chain of SEQ ID NO: 160 and a light chain of SEQ ID NO: 165 (para. 0014), which has identical sequences to Applicant's SEQ ID NOs: 877 and 882, respectively, including the relevant CDRs, which is pertinent to claims 133, 180-181, 185, and 187.
White further teaches that this antibody is useful in treating cancer (para. 0134-0135 and 0178).
White further teaches that the skilled medical practitioner can determine the appropriate dosages of the antibody, as well as the appropriate timings and methods of administration (para. 0310, 0311, and 0347).
White further teaches that the antibody comprises a heavy chain comprising VH-CH1-hinge-CH2-CH3, and a light chain comprising VL-VC, wherein the VC is either kappa or lambda (para. 0015), which is pertinent to claim 182.
White further teaches that the antibody may by an IgG4, and have an S241P mutation in the hinge (para. 0224), which is pertinent to claims 183-184.
White further teaches that the antibody is useful for treatment of pancreatic cancer, glioblastoma, cervical cancer, ovarian cancer, and melanoma, among many others (para. 0339), which is pertinent to claim 194.
While White does not expressly teach the claimed dosages and schedules, it would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to follow the teachings of White to arrive at the claimed invention. White teaches the claimed anti-TIGIT antibody as well as methods of treating cancer by using said antibody. White also teaches that the skilled practitioner can determine appropriate dosages of the antibody, as well as the appropriate schedule and methods of administration. One of ordinary skill could follow the teachings of White to arrive at the claimed invention with nothing more than routine experimentation, with the claimed antibody performing its known, usual function, and affecting a predictable result.
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 133, 180-185, and 187-194 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following claims of the U.S. patents and patent applications listed below in view of White:
Conflicting patent / Conflicting
patent application clams
10,124,061 1-3
11,225,523 1-2, 4, 9-10
12,152,084 1-2, 10-11
18/774,872 59-61, 71-72
18/868,661 23, 25
By means of example, the '084 patent claims a method of treatment for cancer in a patient, comprising administering an anti-TIGIT antibody CPA.9.086.H4(S241P) (claims 1-2).
However, the '061 patent does not claim a dosage schedule.
White teaches an anti-TIGIT antibody comprising a heavy chain of SEQ ID NO: 160 and a light chain of SEQ ID NO: 165 (para. 0014), which has identical sequences to Applicant's SEQ ID NOs: 877 and 882, respectively, including the relevant CDRs, which is pertinent to claims 133, 180-181, 185, and 187.
White further teaches that this antibody is useful in treating cancer (para. 0134-0135 and 0178).
White further teaches that the skilled medical practitioner can determine the appropriate dosages of the antibody, as well as the appropriate timings and methods of administration (para. 0310, 0311, and 0347).
White further teaches that the antibody comprises a heavy chain comprising VH-CH1-hinge-CH2-CH3, and a light chain comprising VL-VC, wherein the VC is either kappa or lambda (para. 0015), which is pertinent to claim 182.
White further teaches that the antibody may by an IgG4, and have an S241P mutation in the hinge (para. 0224), which is pertinent to claims 183-184.
White further teaches that the antibody is useful for treatment of pancreatic cancer, glioblastoma, cervical cancer, ovarian cancer, and melanoma, among many others (para. 0339), which is pertinent to claim 194.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '084 patent with the teachings of White to arrive at the claimed invention. Both White and the claims of the '084 patent are drawn to the same anti-TIGIT antibody. White also teaches that the skilled practitioner can determine appropriate dosages of the antibody, as well as the appropriate schedule and methods of administration. One of ordinary skill could follow the teachings of White for an appropriate dosage of the antibody claimed by the '084 patent to arrive at the claimed invention with nothing more than routine experimentation, with the claimed antibody performing its known, usual function, and affecting a predictable result.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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