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 .
DETAILED ACTION
The amendment filed May 1, 2025 in response to the Office Action of November 1, 2024 is acknowledged and has been entered.
Claims 5, 16 and 20 have been amended.
Claims 1-4 and 6-14 have been cancelled.
Claims 5 and 15-20 are pending and under consideration.
Information Disclosure Statement
Information Disclosure Statement of May 1, 2025 has been entered and considered.
MAINTAINTED/MODIFIED REJECTIONS
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.
Claim 20 is 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 20, which is dependent on claim 19, recites “wherein the antibody is prepared through immunization in rat …”. However, claim 19 recites the “production of the antibody comprising culturing the host cell of claim 18 and isolating the antibody”. It is unclear whether the antibody is made through immunization or expression in a host cell.
Response to Arguments
For the 112(b) rejection, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive. As set forth above, claim 20 is still indefinite because it is unclear whether the antibody is made through expression in a host cell or through immunization in a rat. Thus, the rejection to claim 20 is maintained for the reason of record.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Patent No.: US 11,414,487
Claims 5 and 15-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. US 11,414,487 (hereinafter Pat. 487, corresponding to Appl. No.: 16/333,993, of record).
It is noted that the instant application is a continuation of Appl. 16/333.993, and Pat. 487 and the instant application share the same SEQ listing.
The claims of Pat. 487 teach:
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Thus, the claims of Pat. 487 teach an antibody comprising SEQ ID NO: 2 + SEQ ID NO: 3 (the elected species) of the instant application. See claim 18. The claims of Pat. 487 teach nucleic acid molecule encoding the antibody, a cloning or expression vector comprising the nucleic acid and a process for production of the antibody (claims 4-7).
Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same inventive concept and would have been obvious in view of the co-pending which have all of the characteristics of the claimed nucleic acid molecules encoding antibody encompassed by instant claims, pharmaceutic composition comprising the antibody as set forth above.
Response to Arguments
For the Double Patenting rejection based on Pat. 487, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive. It is noted that the instant application was filed on August 31, 2023. However, the Notice of Allowance of March 31, 2022 for Pat. 487 (Application 16/333,993) states:
“Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on February 18, 2021 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.” Thus, the Applicant’s argument is invalid and Pat. 487 can still be used as a reference.
In addition, as set forth above, claims 4-7 of Pat. 487 are drawn a nucleic acid molecule encoding the antibody, or the antigen binding fragment of claim 1 (claim 4), which are the same antibodies recited by the instant claim 5; a cloning or expression vector comprising the nucleic acid molecule of claim 4 (claim 5); a host cell comprising one or more cloning or expression vectors of claim 5 (claim 6); and a process for the production of the antibody of claim 1, comprising culturing the host cell of claim 6 and isolating the antibody (claim 7), thus claims of Pat. 487 are drawn to the same inventive concept and would have all of the characteristics of the claimed nucleic acid molecules encoding antibody encompassed by instant claims, a vector comprising the said nucleic acid molecules, a host cell comprising the said vector, and a process of making antibody with the said host cell.
Thus, the rejection is maintained for the reasons of record.
Appl. NO.: 17/776,179
Claims 5 and 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-19 of copending Application No. 17/776,179 (thereinafter Appl. 179, US Pub No.: 2022/0387417 A1, of record), in view of Korman (Korman et al., US 8,008,449 B2, Publication Date: 08/30/2011, of record).
The claims of Appl. 179 teach a pharmaceutical combination comprising a substance A and a substance C; wherein the substance A is Compound F, a crystal form thereof, a pharmaceutically acceptable salt thereof or a solvate thereof, the substance C is an antibody N comprising a CDR amino acid sequence selected from the group consisting of SEQ ID NOs: 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50 and 51, or an antigen binding fragment thereof. See claim 10.
The claims of Appl. 179 teach the pharmaceutical combination as defined in claim 10, wherein the antibody N comprises: (b) a heavy chain variable region comprising an amino acid sequence of SEQ ID NO: 30; and a light chain variable region comprising an amino acid sequence of SEQ ID NO: 31. See claim 13. As shown below, SEQ ID NO: 30 of Appl. 179 comprises SEQ ID NO: 2 of the instant Application (the elected species):
US-17-776-179-30
Query Match 100.0%; Score 601; DB 126; Length 115;
Best Local Similarity 100.0%;
Matches 115; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 QVQLVQSGAEVKKPGSSVKVSCKASGFTFTTYYISWVRQAPGQGLEYLGYINMGSGGTNY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 QVQLVQSGAEVKKPGSSVKVSCKASGFTFTTYYISWVRQAPGQGLEYLGYINMGSGGTNY 60
Qy 61 NEKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCAIIGYFDYWGQGTMVTVSS 115
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Db 61 NEKFKGRVTITADKSTSTAYMELSSLRSEDTAVYYCAIIGYFDYWGQGTMVTVSS 115
SEQ ID NO: 31 of Appl. 179 comprises SEQ ID NO: 3 of the instant Application (the elected species):
US-17-776-179-31
Query Match 100.0%; Score 590; DB 126; Length 112;
Best Local Similarity 100.0%;
Matches 112; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 DVVMTQSPLSLPVTLGQPASISCRSSQSLLDSDGGTYLYWFQQRPGQSPRRLIYLVSTLG 60
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Db 1 DVVMTQSPLSLPVTLGQPASISCRSSQSLLDSDGGTYLYWFQQRPGQSPRRLIYLVSTLG 60
Qy 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCMQLTHWPYTFGQGTKLEIK 112
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Db 61 SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCMQLTHWPYTFGQGTKLEIK 112
SEQ ID NO: 2 and SEQ ID NO: 3 are heavy chain and light chain of 2E5, respectively (see Table 1 of the instant specification). 2E5 has HCDRs 1-3 of SEQ ID NOs: 10+11+13 and LCDRs 1-3 of SEQ ID NOs: 14-19-21.
Thus, the antibody of SEQ ID NOs: 30+31 reads on the antibodies of the instant claim 5 (a).
The claims of Appl. 179 teach the pharmaceutical combination as defined in claim 10, wherein the antibody N further comprises a heavy chain constant region of human IgG4, and a light chain constant region of human γ or κ light chain; and/or, the substance C is the antibody N; and/or, the substance A is the mesylate of Compound F; and/or, the pharmaceutical combination further comprises a pharmaceutical excipient. See claim 14.
The antibody of the claims of Appl. 179 comprise antibodies instantly claimed and thus would have the same binding Kd for human and mouse PD-1, same binding property as claimed antibody (e.g. same epitope).
The claims of Appl. 179 teach as set forth above. However, the claims of Appl. 179 do not teach a nucleic acid molecule encoding the antibody or antigen-binding fragment thereof, vector, host cells, or production process as claimed.
Korman teaches that to express the antibodies, or antibody fragments thereof, DNAs encoding partial or full-length light and heavy chains, can be obtained by standard molecular biology techniques and the DNA can be inserted into expression vectors such that the genes are operatively linked to transcriptional and translational control sequences (col. 38, lines 27-34).
Korman teaches that these methods are well known in the art (col. 38, para. 3).
It would have prima facie been obvious to one of ordinarily skilled in the art at the time the invention was filed to use an anti-PD1 antibody comprising SEQ ID NOs: 30+31 for pharmaceutical compositions as taught by the claims of Appl. 179, and to produce the antibody by recombinant DNA techniques and gene transfection methods well known in the art, as taught by Korman. Because the sequences are available and the methods are well-known and widely-used, one of ordinary skill in the art would have had a reasonable expectation of success to reach the claimed methods. The motivation would have been for mass production of a therapeutic antibody with a simple and reliable method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
For the provisional Double Patenting rejection based on Appl. 179, Applicant argues:
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Applicant’s arguments have been fully considered but they are not persuasive because the claims of the instant application are still obvious in view of the co-pending claims and a terminal disclaimer has not been filed. MPEP 804 I-B states: “The “provisional” double patenting rejection should continue to be made by the examiner in each application as long as there are conflicting claims in more than one application unless that “provisional” double patenting rejection is the only rejection remaining in at least one of the applications.” Therefore, the rejections above are maintained for the reasons of record.
NEW REJECTIONS
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 15 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 15, which depends on claim 5, recites “wherein the antibody is … or human antibody”. However, the antibodies recited by the amended claim 5 have rat CDR sequences. Thus, claim 15 fails to further limit the subject matter of claim 5.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
No claims are allowed.
All other rejections set forth in the previous Office Action of November 1, 2024 are hereby withdrawn in view of the claim amendments and Applicants’ arguments.
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 CHENG LU whose telephone number is (571)272-0334. The examiner can normally be reached Monday-Friday 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/CHENG LU/ Examiner, Art Unit 1642
/PETER J REDDIG/ Primary Examiner, Art Unit 1646