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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/13/2026 has been entered.
Claim Status
Claims 1-3, 12-15, and 17-89 were canceled.
Claims 4-11, 16 and 90-91 are pending and under consideration.
CLAIM INTERPRETATION
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Withdrawn Rejections
Rejection of Claim 91 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn. Applicant amended the claim 91, thereby obviating this rejection/objection.
Rejection of Claim 90 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Applicant provided a persuasive argument to overcome this rejection.
Rejection of Claim 87 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn. Applicant canceled the claim 87 and therefore this rejection is moot.
NEW - Claim Rejections - 35 USC § 112
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.
Claims 4-11 and 91 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites that a first antigen binding portion comprises CDR sequences of anti-PVRIG antibody comprising SEQ ID NO: 3179 and 3180; or SEQ ID NO: 1539 and 1544; and a second antigen binding portion comprises CDR sequences of anti-TIGIT antibody comprising 1634 and 1639. However, claim 4 does not recite what numbering scheme is used to identify the CDRs. The table at page 43, paragraph 0199 of instant specification shows different numbering schemes identify different sets of amino acids for CDR sequences. For example, one of ordinary skill in the art would identify residues 27-38 of SEQ ID NO:3179 as vhCDR1 if IMGT numbering scheme is used, but the same residues 27-38 of SEQ ID NO:3179 is not identified as vhCDR1 if AbM numbering scheme is used because AbM requires residue 26. In the absence of specifying a numbering scheme, the person of ordinary skill in the art would not be able to determine if he or she were infringing the claim or not.
Claims 5-11 and 91 depend from claim 4 and do not resolve the issue.
MAINTAINED - 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.
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/033798 (hereinafter WO ‘798; IDS).
WO 2018/033798 was published on 22 February 2018, which is before the effective filing date (01 June 2018) of instant application and therefore is available as 102(a)(1) art.
Regarding claims 90, WO ‘798 teaches anti-PVRIG antibody (paragraph 282). WO ‘798 teaches anti-TIGIT antibody (paragraph 212). WO ‘798 teaches a combination of anti-TIGIT and anti-PVRIG antibodies (paragraph 374). WO ‘798 teaches a combination of anti-TIGIT antibody CPA.9.083 and anti-PVRIG antibody CHA.7.518.1 (paragraph 23). WO ‘798 teaches activating T-cell by administering anti-TIGIT antigen binding domain (claims 1 and 16). Therefore, anti-PVRIG/anti-TIGIT bispecific antibody will also activate T-cell since one of its components anti-TIGIT antigen binding domain is activating T-cell.
Because instant specification disclosed that anti-TIGIT antibody is CPA.9.083 (page 7), “means for monovalently binding TIGIT” recited by claim 90 encompasses CPA.9.083.
With regard to claim limitation “wherein the bispecific antibody induces a higher average maximum IFN-y release by T cells as compared to the combination of a monospecific anti-PVRIG antibody comprising the anti-PVRIG antigen binding portion and a monospecific anti-TIGIT antibody comprising the anti-TIGIT antigen binding portion”, since the bispecific antibody comprising anti-TIGIT antibody CPA.9.083 and anti-PVRIG antibody CHA.7.518.1 is obvious as will be discussed below, the bispecific antibody with same structure will have same function.
The difference between prior art and the instant invention is that WO ‘798 does not teach bispecific antibody comprising anti-PVRIG and anti-TIGIT antibodies.
However, making bispecific antibody from two monospecific antibodies is obvious to one of ordinary skill in the art because making bispecific antibody is conventionally performed and well-known routine experimentation in the art.
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to make combination of these two antibodies in the format of a bispecific antibody because WO ‘798 teaches same anti-PVRIG antibody CHA.7.518.1 and same anti-TIGIT antibody CPA.9.083 as anti-PVRIG antibody and anti-TIGIT antibody portions of the bispecific antibody of instant claims, and WO ‘798 teaches combination of these two antibodies. One of ordinary skill in the art would be motivated to make bispecific antibody to test whether the bispecific antibody has better therapeutic effect than combination of two monospecific antibodies. Since making combination of antibodies in the format of bispecific antibody was well known in the art before the filing date of the claimed invention, bispecific antibody combining anti-PVRIG and anti-TIGIT antibodies would be obvious to one of ordinary skill in the art. Therefore, the invention as a whole would be obvious to one of ordinary skill in the art.
In the office action mailed on 9/15/2025, 103 rejection was withdrawn because Applicant amended independent claim 4 to delete “CHA.9.547.18” to make claim 4 to encompass only CPA.9.086 as anti-TIGIT antibody portion and because Applicant provided a persuasive argument about unexpected result for BsAb-2, 4 and 18 in Applicant’s response 12/13/2023 and BsAb-2, 4 and 18 all comprise CPA.9.086 as shown in figure 52.
However, claim 90 recites “means for monovalently binding human PVRIG” and “means for monovalently binding TIGIT” instead of specific antibody species of CHA.7.518.4, CHA.7.518.1 and CPA.9.086 as in claim 4. Therefore, claim scope of new claim 90 is much wider than amended claim 4, and claim 90 encompasses bispecific antibody comprising CPA.9.083 instead of CPA.9.086 because instant specification disclosed that anti-TIGIT antibody can be CPA.9.083 (page 7) and therefore “means for monovalently binding TIGIT” recited by claim 90 encompasses CPA.9.083.
Unexpected result was shown for BsAb-2, 4 and 18 all of which comprise CPA.9.086 as shown in figure 52, and therefore unexpected result has not been shown for the bispecific antibody comprising CPA.9.083. Therefore, while unexpected result proves non-obviousness for bispecific antibody comprising CPA.9.086, it does not prove non-obviousness for bispecific antibody comprising CPA.9.083. Thus, the bispecific antibody comprising CPA.9.083 encompassed by claim 90 is obvious to one of ordinary skill in the art.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success because WO ‘798 teaches same anti-PVRIG antibody CHA.7.518.1 and same anti-TIGIT antibody CPA.9.083 as anti-PVRIG antibody and anti-TIGIT antibody portions of the bispecific antibody of instant claims, and WO ‘798 teaches that combination of these two antibodies is an effective antibody therapy (paragraph 013). Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
In the response filed on 12/15/2025, Applicant argued at page 11,
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Applicant further argued at page 12,
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Applicant's arguments have been fully considered but they are not persuasive. As Applicant argued above, the claim scope of claim 90 is construed as directed to the corresponding structures disclosed in the specification. Instant specification clearly disclosed that TIGIT-binding domain encompasses not only CPA9.086 but also CPA9.083. (page 7, the appropriate portion of page 7 is reproduced below).
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Therefore, Applicant’s argument that “means for monovalently binding TIGIT” recited by claim 90 encompasses only CPA.9.086 is not persuasive.
Conclusion
Claim 16 is allowed.
Claims 4-11 and 90-91 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHEOM-GIL CHEONG whose telephone number is (571)272-6251. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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/CHEOM-GIL CHEONG/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645