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 .
Claims 7, 9, and 16 have been canceled. Claims 1-6, 8, 10-15 and 17 have been amended. Claims 18-29 have been added. Claims 1-6, 8, 10-15 and 17-29 are pending and under consideration.
The rejection of claim 6 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in light of applicant’s amendment.
The rejection of claims 3, 8, 10, 12-14 and 17 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in light of applicant’s amendments is withdrawn in light of applicant’s amendments.
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.
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.
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.
Claims 1-4, 7, 8, 11, 12, 14, 15 18, 18, 19 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Joubert et al (WO2015/004400, reference of the IDS filed 8/25/2022) as evidenced by US 10,307,488 (English Language Translation) in view of Miao et al (WO2013/173391).
Joubert et al teach antibody drug conjugates comprising linkers wherein the linker comprises a linker head and a linker body, and a method of preparing said linkers (abstract). Joubert et al teach that the antibody drug conjugates comprise a connection to an antibody, a polarity region, a trigger a suicide spacer and a drug (Figure 1). Joubert et al teach the linker 22 (columns 47-48) wherein the linker head is pyridine, having two branches terminate in Bromine, a polarity region and a Val-Cit dipeptide and a p-amino benzyl alcohol:
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which meets the limitations of claim 1 for a conjugation head which is
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, wherein m is 5; a cleavable linker which is
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, and a spacer which is
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.
Joubert et al teach that a preferred antibody of the conjugate includes anti-CD56 antibody (column 22, line 60) which meets that limitation of claim 1. Joubert et al teach a general procedure wherein a solution of the desired antibody is reduced by TCEP and the linker is added (column 50, lines 40-51). One of skill in the art would understand that the free thiol of the reduced antibody would react with the linker resulting in a substitution of the antibody thiol for the bromine. Joubert et al teach an example using the same linker but with an analogous linker head,
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is reacted to form an adduct with MMAE (columns 39-40, structure 9-MMAE):
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which meets the limitation of claim 14 for the linker comprising
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the spacer of
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, and claim 15 for reaction with MMAE 6-(2,6-bis(bromomethyl)pyridine-4-yl)amido-N-hexanamide-valine-citrullline-p-aminobenzoyl carbamate, reacted with the preferred anti-CD56 antibody. Joubert et al teach that after reduction with TCEP (tris(2-carboxyethyl)phosphine), 8 cysteine residues accessible, consequently numerous species with DAR from 0 to 8 and that the average DAR is approximately 4 with conventional modifications (column 4, lines 35-40 and Figure 13). Joubert et al teach that MALDI-TOF mass analysis confirms that the reaction mixture contains 89% of species resulting from grafting of 4 linkers of 6-(3,4-dibromomaleimido)hexanoic acid on the antibody and thus the grafting average is 4.0 (column 4, lines 41-50) which meet the limitation of n=4 in claims 1, 8 and 19.. Joubert does not specifically teach the derivation of linker 22 to form an adduct with MMAE, the resulting number for “n” for the DAR after conjugation of linker 22-MMAE to the TCEP reduced antibody, or the “use” of a composition comprising the antibody-drug conjugate of claim 1 as a drug or for use in the treatment of a CD56+ cancer.
Miao et al teach an analogous antibody-linker-drug conjugate:
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wherein, the linker head differs from the instant linker head, and wherein the carbon adjacent to the exocyclic secondary amine does not carry a carbonyl group (claim 6 of ‘127, column 117). Miao et al teach that drug-conjugates include a multifunctional linker providing a 2-5 atom bridge (column 4, lines 23-24). Miao et al teach that the structural integrity of an antibody can be compromised after opening disulfide bonds and attaching payloads to the exposed free thiols and the compositions and method disclosed provide conjugation through cysteine without decreased structural stability (column 4, lines 32-36). Miao et al teach that the number of molecules of drug attached to the antibody through the multifunctional linker can range from 1-10 (claim 1 of ‘127 , n=1,2,3,4,5,6,7,8,9 or 10) which meets the limitations of claims 2 and 8. Miao et al teach a method of treating a patient with cancer comprising administering an active agent-conjugate as disclosed (column 11, lines 19-22) thus meeting the limitations of claim 11 for use as a drug and claim 12.
It would have been prima facie obvious at the time prior to the effective filing date to react the linker 22 of Joubert et al to form a linker-drug with MMAE and to react the linker-MMAE with the TCEP reduced anti-CD56 antibody to provide the conjugate with MMAE in claims 3 and 18, wherein n is 4 in claim 1, and the conjugate of claims 3 and 18 wherein m is equal to 5 and the method of making the conjugate of claims 27-29 wherein m is equal to 5 One of skill in the art would have been motivated to do so because Miao et al formed an antibody conjugate with a highly similar linker attached to MMAE. Miao et al teach that the linker head provides a 2-5 atom bridge and prevents antibody destabilization after reduction and loading of payloads.
It would have been further prima facie obvious that the resulting product of compound 22 resulting from the conjugation of free thiols on the antibody with linker 22 would have on the order of 89% of the species having a grafting average of 4 because the reaction of the antibody with the TCEP would make 8 cysteines available for reaction (Figure 13 of Joubert et al) to the linker resulting in a DAR of 4.
Applicant argues that the claim 1 has been amended to incorporate the subject matter of claim 9 which was not rejected over Joubert et al (WO2015/004400, reference of the IDS filed 8/25/2022) as evidenced by US 10,307,488 (English Language Translation) in view of Miao et al (WO2013/173391). It is noted that the prior action rejected claim 9 under 112(b) because the scope of the claim could not be determined. Further a DAR of between 3.5 and 4 in previous claim 9, excludes 4. Instant claim 1 now has been qualified to require 4 as the mean number of linker-drugs attached to the antibody which has been determined to be obvious over the teachings of Joubert et al regarding Figure 13 and the further teachings of Joubert et al on the MALDI-TOF mass analysis of the conjugated antibody that comprises an analogous linkers of 6-(3,4-dibromomaleimido)hexanoic which resulted in 89% of species comprising a graft of 4 linkers of 6-(3,4-dibromomaleimido)hexanoic acid on the antibody and thus the grafting average is 4.0 (column 4, lines 41-50) which fulfills that requirement of claims 1 and 8 wherein the mean Drug to Antibody Ratio is 4 and provides a reasonable expectation that the conjugation of linker 22 to an antibody would also have about 89% of species comprising a graft of 4 of linker-drug 22.
Applicant argues that the difference in linker head between Miao et al and what is required in instant claim 1 is not trivial. This has been considered but not found persuasive. The citation of Miao et al is to provide teachings of the remainder of the linker-drug which incorporates the spacer and cytotoxic drug, attached to an analogous linker and conjugation head. The rejection is based on using
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of Joubert et al attached to the MMAE in the same manner as Miao et al attaches the MMAE to the different conjugation head and linker:
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. Thus, the attachment results in a conjugate having the structure of
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as in claim 4. Thus, Miao et al is relied upon for teaching the MMAE drug portion of
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.
Claims 1-8, 10-15, 17-22, 24, 25 and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Joubert et al and Miao et al as applied to claims 1-4, 7, 8, 11, 12, 14, 15 18, 19 and 27-29 above, and further in view of Dimitrov et al (WO2017/023780, reference of the IDS filed 8/25/2022).
Claim 5 requires that A is m906.
Claim 6 specifies, in part, that the antibody drug conjugate of
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Dimitrov et al teach a method of treating a subject having a CD56-positive cancer, comprising selecting a subject with a CD56-positive cancer and administering to the subject a therapeutically effective amount of the ADC of claim 1 (claim 28 of ‘568).wherein the CD56-positive cancer is a neuroblastoma, multiple myeloma, ovarian cancer, acute myeloid leukemia, Wilms tumor or small cell lung cancer (claim 30 of ‘568) which meets the limitations of claim 12 and claim 20 drawn to a myeloma and a hemopathy and claim 21 drawn to acute myeloid leukemia. The CD56+ cancers which include small cell lung cancer meet the limitations of claim 13 and 22. Joubert et al and Miao et al teach that the m906 antibody comprises the variable heavy chain domain of SEQ ID NO: 6 (paragraph [0039]) and the variable light chain domain of SEQ ID NO: 8 (paragraph [0041]). Thus, claim 1 of ‘568 encompasses the m906 anti-CD56 antibody.. Dimitrov et al teach that the antibodies of the invention can be administered as ADC and that any suitable anti-cancer agents can be administered in combination with the immunoconjugates (page 37, lines 26-28) such as cyclophosphamide (page 38, line 4]), etoposide (page 38, line 11) and docetaxel (page 38, line 25) which meets the limitations of claim 10.
It would have been prima facie obvious at the time of the effective filing date to use the m906 antibody and composition comprising the m906 antibody in combination with cyclophosphamide, etoposide or docetaxel of Dimitrov et al as the anti-CD56 antibody of Joubert et al. One of skill in the art would be motivated to do so because Dimitrov et al teaches that the m906 antibody is suitable for admisntration as an ADC, and cyclophosphamide, etoposide or docetaxel can be administered in combination with the immunoconjugate. It would have been prima facie obvious to use the ADC rendered obvious by the combined teachings of Joubert et al and Miao et al in a method of treating CD56+ cancers such as acute myeloid leukemia, and small cell lung cancer because Dimitrov et al teach m906 ADCs used for the treatment of these cancers. The combination of the ADC rendered obvious by the combined teachings of Joubert et al and Miao et al and the further teachings of the particular cancers to be treated with the ADCs as taught by Dimitrov et al in combination with cyclophosphamide, etoposide or docetaxel of Dimitrov et al renders obvious claims 10, 13, 17, 22, 24 and 25.
Claims 1-8, 10-15, 17-22, and 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Joubert et al, Miao et al and Dimitrov et al as applied to claims -8, 10-15, 17-22, 24, 25 and 27-29 above, and further in view of Miller et al (‘Combining ADCs with Immuno-Oncology Agents’, In: Innovations for Next Generation Antibody-Drug Conjugates, Cancer Drug Discovery and Development, M. Damelin, ed., 2018, pp. 11-44).
Claim 26 requires that the antibody used in anti-cancer immunotherapy in the composition of claim 10 is a anti-PD-1 or anti-PD-L1 antibody.
Dimitrov et al teach that the antibodies of the invention can be administered as ADC and that any suitable anti-cancer agents can be administered in combination with the immunoconjugates (page 37, lines 26-28) including other antibodies which specifically target cancer cells (page 38, lines 1-2).
Miller et al teach the combination of cytotoxic payloads comprising auristatins with immune-oncology agents provide profound anti-tumor synergy (page 17, lines 4-12 under the heading “ADCs, Anti-Tumor Immunity and ICD), Miller et al list clinical trials of combined ADCs and Immuno-oncology agents, 15 of which use MMAE as the toxic payload in the ADC combined with the anti-PD-1 antibody and one of which uses MMAE as the toxic payload in the ADC combined with the anti-PD-L1 antibody (page 32, Table 1).
It would have been prima facie obvious at the time prior to the effective filing date to combine anti-PD-L1 antibody or anti-PD-1 antibody with the anti-CD56 ADC rendered obvious by the teachings of Joubert et al, Miao et al and Dimitrov et al. One of skill in the art would be motivated to use the anti-PD-L1 antibody because Dimitrov et al teach combinations of the ADC with other antibodies targeting cancer cells and Miller et al teach that it is used in combination with ADCs carrying MMAE as the cytotoxic payload. One of skill in the art would know that PD-L1 is expressed on tumor cells in the tumor microenvironment and thus it is an anti-body which targets cancer cells. One of skill in the art would also have been motivated to combine the ADC rendered obvious by the teachings of Joubert et al, Miao et al and Dimitrov et al with anti-PD-1. One of skill in the art would have been motivated to do so by the teachings of Miller et al on synergy between auristatins and immune-oncology drugs, and the further teachings of the clinical trials combining ADC comprising MMAE as the toxic payload with anti-PD-1 antibodies.
Claims 1-8, 10-15, 17-25, and 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Joubert et al, Miao et al and Dimitrov et al as applied to claims -8, 10-15, 17-22, 24, 25 and 27-29 above, and further in view of the abstract of Carrigan et al (Cancer Research, 2010, Vol. 70, No.8, suppl., Abstract No. 53350).
Claim 23 requires that the neuroendocrinal carcinoma of claim 13 is a Merkel cell carcinoma.
The combined teachings of Joubert et al, Miao et al and Dimitrov et al render obvious the method of claim 13, wherein the cancer is AML, small cell lung carcinoma which express CD56. None of Joubert et al, Miao et al and Dimitrov et al each or suggest that the CD56+ targeted by the ADC is a Merkel cell carcinoma.
The abstract of Carrigan et al teaches that the majority of Merkel Cell Carcinoma patient tissue express significant levels of CD56 which supports the use of a CD56 targeted compound for treatment (under “Conclusion”). The abstract teaches that once a anti-CD6 ADC is bound to CD56, it is internalized and its cytotoxic payload is released (abstract).
It would have been prima facie obvious at the time prior to the effective filing date to treat subjects with Mekel Cell Carcinoma by administration of the ADC rendered obvious by the combined teachings of Joubert et al, Miao et al and Dimitrov et al. One of skill in the art would have been motivated to do so because Dimitrov et al teach multiple types of cancers that express CD56 and the abstract of Carrigan et al teaches that Merkel cell carcinoma is expressed at a high and homogenous level in the majority of MCC patient tissues.
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.
The provisional rejection of claims 1, 3, 4, 5, 6, and 10-13 the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 18/333,261(reference application) is maintained for reasons of record. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘261 application render obvious the instant claims.
Claims 12, 14 and 14 teach the limitations of instant claims 3, 5, 10-13 to the extent that claim 1 of the ‘261 application encompasses the structure of claim 12. The claims of ‘261 fail to teach that the mean DAR is 4.
Joubert et al teach antibody drug conjugates comprising linkers wherein the linker comprises a linker head and a linker body, and a method of preparing said linkers (abstract). Joubert et al teach that the antibody drug conjugates comprise a connection to an antibody, a polarity region, a trigger a suicide spacer and a drug (Figure 1). Joubert et al teach the linker 22 (columns 47-48) wherein the linker head is pyridine, having two branches terminate in Bromine, a polarity region and a Val-Cit dipeptide and a p-amino benzyl alcohol:
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which meets the limitations of claim 1 for a conjugation head which is
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, wherein m is 5; a cleavable linker which is
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, and a spacer which is
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.
Joubert et al teach that a preferred antibody of the conjugate includes anti-CD56 antibody (column 22, line 60) which meets that limitation of claim 1. Joubert et al teach a general procedure wherein a solution of the desired antibody is reduced by TCEP and the linker is added (column 50, lines 40-51). One of skill in the art would understand that the free thiol of the reduced antibody would react with the linker resulting in a substitution of the antibody thiol for the bromine. Joubert et al teach an example using the same linker but with an analogous linker head,
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is reacted to form an adduct with MMAE (columns 39-40, structure 9-MMAE):
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which meets the limitation of claim 14 for the linker comprising
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the spacer of
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, and claim 15 for reaction with MMAE 6-(2,6-bis(bromomethyl)pyridine-4-yl)amido-N-hexanamide-valine-citrullline-p-aminobenzoyl carbamate, reacted with the preferred anti-CD56 antibody. Joubert et al teach that after reduction with TCEP (tris(2-carboxyethyl)phosphine), 8 cysteine residues accessible, consequently numerous species with DAR from 0 to 8 and that the average DAR is approximately 4 with conventional modifications (column 4, lines 35-40 and Figure 13). Joubert et al teach that MALDI-TOF mass analysis confirms that the reaction mixture contains 89% of species resulting from grafting of 4 linkers of 6-(3,4-dibromomaleimido)hexanoic acid on the antibody and thus the grafting average is 4.0 (column 4, lines 41-50) which meet the limitation of n=4 in claims 1, 8 and 19..
It would have been prima facie obvious at the time prior to the effective filing date that the index number “n” in the claims of the ‘261 application was “4”. One of skill in the art would have been motivated to select the number 4 for “n” and the DAR based on the teachings of Joubert et al regarding Figure 13 and the MALDI-TOF mass analysis of the conjugated antibody that comprises an analogous linkers of 6-(3,4-dibromomaleimido)hexanoic which resulted in 89% of species comprising a graft of 4 linkers of 6-(3,4-dibromomaleimido)hexanoic acid on the antibody and thus the grafting average is 4.0 (column 4, lines 41-50) which fulfills that requirement of claims 1 and 8 wherein the mean Drug to Antibody Ratio is 4 and provides a reasonable expectation that the conjugation of linker 22 to an antibody would also have about 89% of species comprising a graft of 4 of linker-drug 22.
Applicant argues that the claims of ‘261 fail to teach the limitation of amended claim 1. This has been considered but not found persuasive for the reasons set forth above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
All claims are rejected.
All other rejections and/or objections as set forth in the prior Office action are withdrawn in light of applicant’s amendments.
Conclusion
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 KAREN A CANELLA whose telephone number is (571)272-0828. The examiner can normally be reached M-F 10-6:30.
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KAREN A. CANELLA
Examiner
Art Unit 1643
/Karen A. Canella/Primary Examiner, Art Unit 1643
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