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 response to the previous Office action, dated August 25, 2026, has been received. By way of this submission, Applicant has amended the specification claims 133, 180, and 190-191, cancelled claims 181 and 185-186, and introduced new claim 195.
Claims 133, 180, 182-184, and 187-195 are pending in the application and under examination before the Office.
The rejections of record can be found in the previous Office action, dated June 3, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 25, 2026 was filed after the mailing date of the first Office action on the merits on June 3, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The specification was previously objected to due to the presence of browser-executable code.
Applicant's amendment to the specification has addressed this issue, and this objection is hereby withdrawn.
Response to Arguments
Claims 133, 180, 182-184, and 188-194 were previously rejected on the basis that the claim contained an improper Markush grouping of alternatives.
Applicant's amendment to the specification has addressed this issue, and this rejection is hereby withdrawn.
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).
Applicant argues that White does not teach or suggest the presently claimed dosage range for the specifically recited anti-TIGIT antibody, and there is no motivation or a reasonable expectation of success for modifying White to arrive at the presently claimed invention. Applicant further argues that the rejection identifies no antibody-specific clinical information from which an expectation of success could have arisen. Applicant cites Example 6 of the specification demonstrates that the claimed range possesses unexpected and surprising results in clinical efficacy in treating cancer.
Applicant's arguments have been considered fully but are not found to be persuasive.
White is explicit in teaching that suitable dosages may be discovered by routine experimentation by those skilled in the art. White at para. 0310-0311:
"The dosing amounts and frequencies of administration are, in a preferred embodiment, selected to be therapeutically or prophylactically effective. As is known in the art, adjustments for protein degradation, systemic versus localized delivery, and rate of new protease synthesis, as well as the age, body weight, general health, sex, diet, time of administration, drug interaction and the severity of the condition may be necessary, and will be ascertainable with routine experimentation by those skilled in the art.
In order to treat a patient, a therapeutically effective dose of the Fc variant of the present invention may be administered. By 'therapeutically effective dose' herein is meant a dose that produces the effects for which it is administered. The exact dose will depend on the purpose of the treatment, and will be ascertainable by one skilled in the art using known techniques."
The teachings of White make it clear that determination of a suitable dosing regimen was well within the grasp of the ordinary practitioner, and could be determined by routine experimentation. This is an express motivation for one of ordinary skill to determine the optimal dosage through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Applicants can rebut a prima facie case of obviousness by showing the criticality of the range. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05(III)(A). Applicant has not met the above burden of showing an unexpected criticality.
White teaches that the claimed anti-TIGIT antibody is useful for treating cancer (para. 0133-0136 and 0178, also see para. 0340). This is at least a general expectation of success that the claimed antibody would be useful in treating cancer.
Applicants must show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). MPEP 716.02(a)(I). Given that the claimed antibody was known to be useful in treating cancer, according to the teachings of White, Applicant's results cannot be said to be unexpected.
The rejection under 35 U.S.C 103 to claims 133, 180, 182-184, and 187-194 in view of White is therefore maintained and extended to include new claim 195.
Applicant has requested that the outstanding nonstatutory double patenting rejections described previously be held in abeyance until there is an indication of allowable subjected matter. As there is no allowable subject matter in the application for reasons described above, these rejections are therefore maintained and extended to include new claim 195.
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, 182-184, and 187-195 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 be 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, 182-184, and 187-195 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 be 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.
THIS ACTION IS MADE FINAL. 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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 6:00 to 2:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Primary Examiner, Art Unit 1644
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