DETAILED ACTION
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 .
Claim Status
Claims 1-2 have been cancelled; claims 3-17 and 19-20 have been amended; and, claim 21 has been newly added, as requested in the amendment filed on 03/16/2026. Following the amendment, claims 3-21 are pending in the instant application.
Claims 17-20 and new claim 21, which depends from claim 20, stand as withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention in the Response filed 11/04/2025, there being no allowable generic or linking claim.
Claims 3-16 are under examination in the instant office action.
Priority - Updated
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. It is further noted that an English translation of the foreign priority document has been provided, and as such the claim to foreign priority has been perfected.
Claims 1-16 have an effective filing date of August 7, 2020 corresponding to CN202010790328.3.
Claim Interpretation
With regard to the sequence language of the instantly amended claims, the following are noted:
The recitation of, for example, “HCDR1 which comprises the amino acid sequence set forth in any one of SEQ ID NOs: 1-6” is being interpreted as closed sequence language, wherein the recitation of “the amino acid sequence” indicates that a reference sequence must comprise or consist of a full-length sequence corresponding to one of SEQ ID NOs: 1-6 in order to meet the limitation. This interpretation pertains to claims 3-15.
The recitation of, for example, “LCDR3 which comprises an amino acid sequence set forth in any one of SEQ ID NOs: 28-31” is being interpreted as open claim language, wherein the recitation of “an amino acid sequence” indicates that a reference sequence must comprise an amino acid sequence of at least two contiguous amino acids comprised within one of SEQ ID NOs: 28-31 in order to meet the limitation. As such, truncations/fragments of the recited sequences for LCDR3 meet the above-recited limitation. This interpretation pertains to claim 3.
The recitation of, for example, “a sequence having at least 90% identity to the sequence set forth in SEQ ID NO: 33” is being interpreted such that a reference sequence must have at least 90% identity to full-length SEQ ID NO: 33 in order to meet the limitation. This interpretation pertains to claims 5, 7, 9, and 12.
Art-Free Subject Matter
As noted in the previous Office Action, the elected species of antibody or antigen-binding fragment thereof that specifically binds to PD-L1 that comprises the exact, full-length HCDRs 1-3 and the LCDRs 1-3 set forth in SEQ ID NOs 1/11/17 and 19/24/28, has been thoroughly searched and is considered to be free of the prior art. However, the instant claims suffer from deficiencies under 35 U.S.C 112 as detailed below.
Drawings - Objection Withdrawn
Applicant has submitted replacement drawing sheets for Figures 1-2 wherein the text/figure labels are clear and legible. As such, the objection to the drawings is withdrawn.
Specification - Objection Withdrawn
Applicant has submitted an amended specification wherein trade names and/or marks used in commerce are properly represented and are accompanied by their generic terminology. As such, the objection to the specification is withdrawn.
Claim Rejections - 35 USC § 112 - Withdrawn
Claims 1-2, 4, 10-11, 13, and 15 were rejected 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. Claims 1-2 have been cancelled, rendering their rejection moot. Claims 4, 10-11, 13, and 15 have been amended such that the claims are drawn to antibodies or antigen-binding fragments thereof that require six CDRs that are defined by full-length sequences which are adequately described by the instant specification. As such, the rejection of claims 1-2, 4, 10-11, 13, and 15 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.
Claim Rejections - 35 USC § 112 - Improper Markush - Withdrawn
Claims 1-16 were rejected on the basis that they contained an improper Markush grouping of alternatives. Claims 1-2 have been cancelled, rendering their rejection moot. Furthermore, independent claim 3 has been amended such that an antibody or antigen-binding fragment thereof that specifically binds PD-L1 comprises six CDRs (HCDRs 1-3 and LCDRs 1-3), wherein said recited CDRs are shared across the possible alternatives. As such, the rejection of claims 1-16 on the basis that they contained an improper Markush grouping of alternatives is withdrawn.
Claim Rejections - 35 USC § 102 - Withdrawn
Claims 1-3, 5-11, and 14-16 were rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2020/216379 A1 (herein after referred to as "Fang"; previously cited on PTO-892).
It is noted that claims 1-2 have been cancelled, rendering their rejection moot. As amended, independent claim 3 requires, as pertains to the instantly elected antibody species, an antibody or antigen-binding fragment thereof that specifically binds to PD-L1 that comprises full-length HCDRs 1-3 corresponding to SEQ ID NOs: 1/11/17, respectively, full-length LCDRs 1-2 corresponding to SEQ ID NOs: 19/24, respectively, and LCDR3 comprising an amino acid sequence of SEQ ID NO: 28. It is noted that Fang only discloses fragments of the above-listed sequences, and as such Fang does not anticipate the claims as amended (specifically, as pertains to the required full-length CDR sequences). Thus, the rejection of claims 1-3, 5-11, and 14-16 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Fang is withdrawn.
Claim Rejections - 35 USC § 103 - Withdrawn
Claims 1 and 12-13 were rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/216379 A1 (herein after referred to as "Fang"; previously cited on PTO-892) in view of US 2015/0073129 A1 (herein after referred to as "Herting"; previously cited on PTO-892).
As acknowledged above: (i) claim 1 has been cancelled, rendering its rejection moot; and (ii) as amended, independent claim 3 requires, as pertains to the instantly elected antibody species, an antibody or antigen-binding fragment thereof that specifically binds to PD-L1 that comprises full-length HCDRs 1-3 corresponding to SEQ ID NOs: 1/11/17, respectively, full-length LCDRs 1-2 corresponding to SEQ ID NOs: 19/24, respectively, and LCDR3 comprising an amino acid sequence of SEQ ID NO: 28. It is noted that Fang only discloses fragments of the above-listed sequences, and as such Fang in combination with Herting does not render obvious amended claims 12-13, which depend from claim 3. As such, the rejection of claims 1 and 12-13 under 35 U.S.C. 103 as being unpatentable over Fang in view of Herting is withdrawn.
Double Patenting - Withdrawn
Claims 1-2 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6, 8, 34, 36-37, 39, and 41 of copending Application No. 18/681,485 (herein after referred to as "first reference application"). Although the claims at issue are not identical, they are not patentably distinct from each other because they all read on an anti-PD-L1 antibody comprising the instantly claimed sequences.
Claims 1-2 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 13, 15-17, and 19 of copending Application No. 18/035,591 (herein after referred to as "second reference application"). Although the claims at issue are not identical, they are not patentably distinct from each other because they all read on an anti-PD-L1 antibody comprising the instantly claimed sequences.
With regard to the above-listed provisional claim rejections under nonstatutory double patenting, it is noted that claims 1-2 have been cancelled, rendering their rejection moot. As such, the above-listed provisional claim rejections under nonstatutory double patenting are withdrawn.
Claim Rejections - 35 USC § 112 - Maintained
Claims 3, 5-9, 12, 14, and 16 stand as rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As amended, instant claim 3 is drawn to an antibody or antigen-binding fragment thereof that specifically binds to PD-L1 and comprises “an HCDR1 which comprises the amino acid sequence set forth in any one of SEQ ID NOs: 1-6, an HCDR2 which comprises the amino acid sequence set forth in any one of SEQ ID NOs: 7-16, an HCDR3 which comprises the amino acid sequence set forth in SEQ ID NO: 17 or 18, and an LCDR1 which comprises the amino acid sequence set forth in any one of SEQ ID NOs: 19-23, an LCDR2 which comprises the amino acid sequence set forth in any one of SEQ ID NOs: 24-27, and an LCDR3 which comprises an amino acid sequence set forth in any one of SEQ ID NOs: 28-31”. It is noted that LCDR3 comprises “an amino acid sequence set forth in any one of SEQ ID NOs: 28-31”, and as such truncations/fragments of this CDR are included in the claim limitation. As indicated in the previous Office Action (12/16/2025), only 11 species of PD-L1 antibodies have been adequately described in Table 1 of the instant specification (Page 46); these 11 antibodies have been adequately described by the recitation of complete heavy and light chain sequences, which together comprise six full-length CDRs (HCDRs 1-3 and LCDRs 1-3). Thus, even though Applicant has disclosed numerous species of antibodies that bind PD-L1, Applicant is claiming a large and structurally diverse genus of PD-L1 antibody species. It is therefore maintained that, absent empirical determination, one skilled in the art would be unable to immediately envision, recognize, or distinguish at least most of the members comprised within the genus claimed, specifically which possible combinations of CDRs with a truncated/mutated LCDR3, yield antibodies or antigen-binding fragments thereof that are capable of specifically binding PD-L1. Accordingly, it is maintained that Applicant’s disclosure is not sufficient to demonstrate possession of the entire claimed genus, and Applicant’s disclosure does not satisfy the written description requirement of 35 U.S.C. 112(a).
Claims 5-9, 12, 14, and 16 stand as included in this rejection as they depend from and/or incorporate claim 3.
Response to Arguments
Applicants argue that claim 3 is amended to be an independent claim and recite all 6 CDRs. Applicants argue that claims 9 and 14 as amended directly or indirectly depend from As
such, recitation of 80% identical sequences and amino acid substitutions does not lead to variability in the CDRs. Applicants argue that because claims 9 and 14 depend from claim 3, they necessarily have all limitations of claim 3. Applicants argue that recitation of 80% identical sequences and amino acid substitutions does not lead to variability in the CDRs.
The argument shave been considered but are not persuasive. Claim 3 still recites LCDR3 comprises “an amino acid sequence of” the listed SEQ ID NOs, therefore broadly encompasses truncated sequences as small as two consecutive amino acid found in the LCDR3 SEQ ID NOs. The species of antibodies are still drawn to a vast genus of sequence variants required to bind PD-L1 and the specification does not provide adequate written description for the genus having variable LCDR3 sequences and binding PD-L1 for the reasons of record.
Contrary to arguments, claims 9 and 14 do not recite that the 20% sequence discrepancy does not occur in the CDR sequences recited in claim 3. Therefore, claims 9 and 14 encompass a broad genus of CDR sequence variants and remain rejected for the reasons of record.
Claim Rejections - 35 USC § 112 - New as Necessitated by Amendment
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 5, 9-10, 12, and 14-15 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 5 recites the limitation "the heavy chain" in line 2. There is insufficient antecedent basis for this limitation in the claim. Independent claim 3 from which claim 5 depends does not recite a full-length IgG antibody, and as such a full-length heavy chain is not required, and thus the limitation “the heavy chain” in claim 5 lacks proper antecedent basis.
Claim 9 recites the limitations "the heavy chain variable region" and "the light chain variable region" in lines 2 and 7, respectively. There is insufficient antecedent basis for these limitations in the claim. Independent claim 3 from which claim 9 depends does not recite a full-length IgG antibody, and as such a full-length heavy chain region nor a full-length light chain are required, and thus the limitations “the heavy chain variable region” and “the light chain variable region” in claim 9 lack proper antecedent basis.
Claim 10 recites the limitations "the heavy chain variable region" and "the light chain variable region" in lines 2 and 4, respectively. There is insufficient antecedent basis for these limitations in the claim. Claim 4 from which claim 10 depends, and corresponding independent claim 3, does not recite a full-length IgG antibody, and as such a full-length heavy chain nor a full-length light chain are required, and thus the limitations “the heavy chain variable region” and “the light chain variable region” in claim 10 lack proper antecedent basis.
Claim 12 recites the limitations "the heavy chain constant region" and "the light chain constant region" in lines 2 and 7, respectively. There is insufficient antecedent basis for these limitations in the claim. Independent claim 3 from which claim 12 depends does not recite a full-length IgG antibody, and as such a heavy chain constant region nor a light chain constant region are required, and thus the limitations “the heavy chain constant region” and “the light chain constant region” in claim 12 lack proper antecedent basis.
Claim 14 recites the limitations "the heavy chain" and "the light chain" in lines 2 and 7, respectively. There is insufficient antecedent basis for these limitations in the claim. Independent claim 3 from which claim 14 depends does not recite a full-length IgG antibody, and as such a full-length heavy chain nor a full-length light chain are required, and thus the limitations “the heavy chain variable region” and “the light chain variable region” in claim 14 lack proper antecedent basis.
Claim 15 recites the limitations "the heavy chain" and "the light chain " in lines 2 and 3, respectively. There is insufficient antecedent basis for these limitations in the claim. Independent claim 15 does not recite a full-length IgG antibody, and as such a full-length heavy chain nor a full-length light chain are required, and thus the limitations of “the heavy chain” and “the light chain” lack proper antecedent basis.
Double Patenting - Maintained
Claims 3-15 stand as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6, 8, 34, 36-37, 39, and 41 of copending Application No. 18/681,485 (herein after referred to as "first reference application"). Although the claims at issue are not identical, they are not patentably distinct from each other because they all read on an anti-PD-L1 antibody comprising the instantly claimed sequences.
Claim 16 stands as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-4, 6, 8, 34, 36-37, 39, and 41 of copending Application No. 18/681,485 (herein after referred to as "first reference application"), as applied to claims 1-15 above, and in further view of WO 2020/216379 A1 (herein after referred to as "Fang"; previously cited on PTO-892).
Claims 3-16 stand as provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 8-10, 13, 15-17, and 19 of copending Application No. 18/035,591 (herein after referred to as "second reference application"). Although the claims at issue are not identical, they are not patentably distinct from each other because they all read on an anti-PD-L1 antibody comprising the instantly claimed sequences.
Response to Arguments
With regard to Applicant’s argument regarding the above-listed copending applications having been filed after the instant application, it is noted that the cited case Ex parte Baurin is not precedential. Furthermore, it is specifically noted that:
MPEP 804(I)(B) recites “[a]n examiner may become aware of two or more copending applications which share the same inventive entity, at least one common (joint) inventor, a common applicant, and/or a common owner/assignee, or that claim an invention resulting from activities undertaken within the scope of a joint research agreement as defined in 35 U.S.C. 102(c) or pre-AIA 35 U.S.C. 103(c)(2) and (3), that would raise an issue of double patenting if one of the applications became a patent. Where this issue can be addressed without violating the confidential status of applications (35 U.S.C. 122), the courts have sanctioned the practice of making applicant aware of the potential double patenting problem if one of the applications became a patent by permitting the examiner to make a provisional rejection on the ground of double patenting. In re Mott, 539 F.2d 1291, 190 USPQ 536 (CCPA 1976); In re Wetterau, 356 F.2d 556, 148 USPQ 499 (CCPA 1966).”
MPEP 804(I)(B)(1)(i) recites “[i]f a provisional nonstatutory double patenting rejection is the only rejection remaining in an application having the earlier patent term filing date, the examiner should withdraw the rejection in the application having the earlier patent term filing date and permit that application to issue as a patent, thereby converting the provisional nonstatutory double patenting rejection in the other application into a nonstatutory double patenting rejection upon issuance of the patent.”
Thus, the provisional claim rejections under nonstatutory double patenting listed above are deemed proper and are therefore maintained as the provisional rejections under nonstatutory double patenting are not the only remaining rejections.
Conclusion
Claims 3-21 are pending. Claims 17-21 are withdrawn. Claims 3-16 are rejected. No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ALYSSA RAE STONEBRAKER whose telephone number is (571)270-0863. The examiner can normally be reached Monday-Thursday 7:00 am - 5:00 pm.
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/ALYSSA RAE STONEBRAKER/Examiner, Art Unit 1642
/Laura B Goddard/Primary Examiner, Art Unit 1642
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