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 .
Status of the Claims
Claims 1-62 were originally filed 10 December 2021. The preliminary amendment filed 36 August 2022 has been entered. Claims 53-62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12 February 2025.
Claims 1-6, 23, 25, and 36-65 are currently pending and under consideration.
Withdrawn Claim Objections
In view of Applicant’s amendments to claim 6 the claim objection is hereby withdrawn.
In view of Applicant’s amendments to claim 50 and 52 to resolve the multiple dependent claims the objection to claims 50-52 are hereby withdrawn.
Withdrawn Claim Rejections
In view of Applicant amending claim 1 to recite particular sets of HCDRs1-3 and LCDRs1-3 the 35 USC § 112(a) rejections (i.e., scope of enablement and written description) of claims 1 and 3-6 are hereby withdrawn.
In view of Applicant amending claim 1 and cancelling claims 6, 8, 10, 11, and 15 the 35 USC § 112(b) rejection (i.e., claims 1, 8, 10, 11, and 15) and 35 USC § 112(d) rejection (i.e., claims 6, 8, 10, 11, and 15) of said claims is hereby withdrawn.
Maintained Claim Rejections
Claim Rejections – 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
It is noted the following rejections has been modified to reflect the portions of the 35 USC § 112(a) (i.e., enablement, written description) rejections set forth in the previous Non-Final Office action mailed 10 April 2025 which are maintained
Claims 2, 23, 25, 36-49, and 63-65 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for i. humanized (see claim 2), ii. particular pairs sets of CDRs (see claim 23), and iii. particular pairs of VH and VL regions (see claim 25), does not reasonably provide enablement for i. a fully human antibody or antigen binding domain thereof (see claim 2), ii. heavy and light chain variable regions comprising CDRs wherein the CDRs can comprise a substitution at any position to any amino acid (see claim 23), and iii. any combination of VH and VL sequences selected each from a group of three (see claim 25). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Applicant's arguments filed 11 August 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the amendments to the claims overcome the 35 USC § 112(a) rejection (i.e., enablement) (see Remarks pg. 10 lines 6-8).
While claim 1 has been amended to recite particular sets of HCDRs1-3 and LCDRs1-3, claim 2 still recites, “wherein the antibody is fully human” in line 1, claim 23 recites “except that at least one of the heavy chain CDRs differs by a single amino acid substitution relative to its reference CDR” (see claims pg. 5 last two lines of 1st para) and “except that at least one of the light chain CDRs differs by a single amino acid substitution relative to its reference CDR” (see claims pg. 5 last two lines of 2nd para), and claim 25 is drawn to combinations of VH and VL pairs. Therefore, the 35 USC § 112(a) rejection (i.e., enablement) of claims 2, 23, 25, 36-49, and 63-65 is hereby maintained for the reasons made of record.
Claims 2, 23, 25, 36-49, and 63-65 are 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.
Applicant's arguments filed 11 August 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the amendments to the claims overcome the 35 USC § 112(a) rejection (i.e., written description) (see Remarks pg. 10 lines 6-8).
While claim 1 has been amended to recite particular sets of HCDRs1-3 and LCDRs1-3, claim 2 still recites, “wherein the antibody is fully human” in line 1, claim 23 recites “except that at least one of the heavy chain CDRs differs by a single amino acid substitution relative to its reference CDR” (see claims pg. 5 last two lines of 1st para) and “except that at least one of the light chain CDRs differs by a single amino acid substitution relative to its reference CDR” (see claims pg. 5 last two lines of 2nd para), and claim 25 is drawn to combinations of VH and VL pairs. Therefore, the 35 USC § 112(a) rejection (i.e., written description) of claims 2, 23, 25, 36-49, and 63-65 is hereby maintained for the reasons made of record.
Claim Rejections - 35 USC § 112(b)
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.
It is noted the following rejection has been modified to reflect the portions of the 35 USC § 112(a) (i.e., enablement) rejection set forth in the previous Non-Final Office action mailed 10 April 2025 which is maintained
Claim 23, 36-49, and 63-65 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.
Applicant's arguments filed 11 August 2025 (referred to herein as Remarks) have been fully considered but they are not persuasive.
Applicant argues the amendments to the claims overcome the 35 USC § 112(a) rejection (i.e., written description) (see Remarks pg. 10 lines 15-17).
Claims 23 still recites “IMGT® numbering” (e.g., line 5) and the ambiguity regarding both the reference germline CDRs and the CDR positions (see Non-Final Action mailed 04/10/2025, pg. 11, 1st-2nd para). In addition, claim 36 is remains drawn to a fragment while depending from claim 23 which is drawn to an antigen binding fragment.
Therefore the 35 USC § 112(b) rejection of claims 23, 36-49, and 63-65 is hereby maintained.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-6, 23, 25, 40, 42-44, 48, 50, and 51 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO2020113224 A2 (referred to herein as Marasco, as cited on the IDS received 04/15/2025 pg. 6 Foreign Patent Document #11) published 04 June 2020 with an earlier priority date of 30 November 2018 (instant application has a priority date of 14 June 2019).
The applied reference has common inventors (i.e., Marasco, Shu, and Chang) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Applicant argues the amendments to claim 1 overcomes the 35 USC § 102(a) rejection (see Remarks pg. 11 lines 5-10).
While claim 1 has been amended to recite particular sets of 6 CDRs Marasco recites PD-1 antibodies with identical sets of CDRs. For example, PD-1 antibody P4-B3 comprising the following HCDRs1-3
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66
411
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(see Marasco pg. 48, table), LCDRs1-3
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65
408
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Greyscale
(see Marasco pg. 49, table), VH, and VL sequences
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140
515
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Greyscale
(see Marasco Figure 83, pg. 88 of 92 in drawings). Thus, Applicant’s claim amendments do not overcome the 35 USC § 102(a)(2) rejection of claims 1-6, 23, 25, 40, 42-44, and 48 and is therefore maintained for the reasons made of record.
Regarding claims 50 and 51, previously not examined due to multiple dependency, Marasco discloses the invention encompasses a vector comprising the nucleic acid construct and a cell comprising the vector (see Marasco pg. 4 para [0019, 0020]).
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 (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 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 36-39, 41, 45-47, 49, 52, and 63-65 are rejected under 35 U.S.C. 103 as being obvious over Marasco, Rafiq (as cited on the PTO-892 mailed 04/10/2025), and Dahlen (as cited on the PTO-892 mailed 04/10/2025).
The applied reference has common inventors (see above) with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Applicant argues the amendments to claim 1 overcomes the 35 USC § 102(a) rejection and therefore also overcomes the 35 USC § 103 rejection of claims 36-39, 41, 45-47, and 49 (see Remarks pg. 11 lines 19-21).
For the reasons stated above the 35 USC § 102(a)(2) rejection is maintained and therefore the 35 USC 103 rejection of claims 36-39, 41, 45-47, and 49 is hereby maintained.
Regarding claim 52, previously not examined due to multiple dependency, Marasco discloses the invention encompasses a kit comprising the same and a syringe (see Marasco pg. 72 para [00290]-pg. 74 para [00296]). Pursuant to MPEP § 2112.01 non-functional printed matter does not distinguish claimed product from otherwise identical prior art product, therefore, instant claim 52 drawn to a kit including instructions are obvious over the prior art. Therefore, claim 52 is obvious over Marasco.
Regarding newly added claims 63 and 64, as stated in the Non-Final Action mailed 10 April 2025, a person of ordinary skill in the art would modify/substitute the monoclonal PD -1 scFv-Fc nucleic acid, vector, and host cell expressing the former taught by Marasco or monoclonal PD-1 scFv taught by Rafiq for a nucleic acid, vector, and host cell expressing the former of the PD-1xLAG-3 bispecific antigen binding domains taught by Dahlen given i. the synergistic effects taught by Dahlen, ii. Marasco teaches the second polypeptide can be multi-specific and LAG-3 as a target antigen of the second polypeptide, and iii. Rafiq teaches combination scFvs for increased efficacy of CAR T therapy (see Marasco pg. 44 para [00178], pg. 55 para [00215-00216)).
Regarding claim 65, a person of ordinary skill in the art would modify/substitute the kit comprising the monoclonal PD -1 scFv-Fc and syringe taught by Marasco for the PD-1xLAG-3 bispecific antigen binding domains taught by Dahlen given i. the synergistic effects taught by Dahlen, ii. Marasco teaches the second polypeptide can be multi-specific and LAG-3 as a target antigen of the second polypeptide, and iii. Rafiq teaches combination scFvs for increased efficacy of CAR T therapy (see Marasco pg. 72 para [00290]-pg. 74 para [00296]). Pursuant to MPEP § 2112.01 non-functional printed matter does not distinguish claimed product from otherwise identical prior art product, therefore, instant claim 52 drawn to a kit including instructions are obvious over the prior art. Therefore, claim 52 is obvious over Marasco, Rafiq, and Dahlen.
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 1-6, 23, 25, 40, 42-44, and 48 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 7, 19, 21-23, and 35-42 of copending Application No. 17/618,361 9referred to herein as ‘618). Although the claims at issue are not identical, they are not patentably distinct from each other.
Applicant requests the nonstatutory double patenting rejection be held in abeyance until allowable subject matter is identified (see Remarks pg. 11 last two lines).
Therefore, given the instant application has outstanding rejections the above non-statutory double patenting rejection is hereby maintained.
Regarding instant claims 50-52, the ‘618 application also claims the following:
A vector comprising the nucleic acid (see ‘618 claim 40; see instant claim 50),
A cell comprising the vector (see ‘618 claim 41; see instant claim 51), and
A kit comprising the at least one antibody composition, a syringe, and instructions for use (see ‘618 application claim 42; see instant claim 52).
Therefore, claims 50-52 have been added to the above nonstatutory double patenting rejection.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim 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 HILARY ANN PETRASH whose telephone number is (703)756-4630. The examiner can normally be reached Monday-Friday 8:30-4:30 EST.
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/H.A.P./Examiner, Art Unit 1644 /AMY E JUEDES/Primary Examiner, Art Unit 1644
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