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 .
Acknowledgement is made of applicant’s election without traverse of the species “(a)” pertaining to Z as a connecting group obtained by a metal-free click reaction.
Claims 1-27 are pending. Claims 16 and 25 have been amended. Claims 15, 16, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected specie, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/30/2026. Claims 1-14, 17-23 and 25-27 are examined on the merits to the extent that they read on the elected species.
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 1-14, 17-23, 26 and 27 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.
(A)The recitation of formula (3) in claim 5 lacks antecedent basis in claim 4.
(B)The recitation of Sp1 in claim 5 lacks antecedent basis in claim 4
(C)Claims 8, 9, and 18are vague and indefinite in the recitation of “Su is a monosaccharide” and “G is a monosaccharide moiety”. It is unclear how a monosaccharide moiety differs form the monosaccharide per se.
(D)Claims 1, 2, 8, 10, and 19 set forth strcutres (1), (2), (1f), (1b), and (5). In all of said strcutres there is
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which is defined by the claims as contrary to the standard meaning of a cyclo-hexane ring. The claims state that this drawing represents a 5 or 6-m aromatic or heteroaromatic ring. Because this moiety is integral to the structures 1, 1f, 1b, 2 and 5 wherein the remainder of the strcutres are taken to be drawn conventionally, it is unclear if the two bonds emanating from the moiety are meant to be confined to the para orientation, or if any of the carbons could be used to join the linkages to the rest of themolecule. Further, it is unclear what carbons are to be used for the two linkages in the 5-m ring which has no para position.
(E)Claim 2 recites “wherein L2 has structure (2)”. However, structure (2) includes more of structure (1) than just L2, such as the exatecan drug. It is unclear what applicant intends as the metes and bounds of this claim.
(F)Claim 2 recites “the wavy bond labeled with ** is connected to NH”. It is unclear where NH is in the structure (1) of claim 1.
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.
Claims 1-8, 10-14, 17-23 and 26-27 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.
Section 2163 of the M.P.E.P. states that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A “representative number of species” means that the species which are adequately described are representative of the entire genus. See, e.g., AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus to provide a “representative number” of species. The “structural features common to the members of the genus” needed for one of skill in the art to ‘visualize or recognize’ the members of the genus takes into account the state of the art at the time of the invention.
The specification provides no evidence of reduction to practice of the linker wherein
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is a 5-m-heteroaromatic ring, or a 6-m-heteroaromatic ring. It is noted that the 5-m aromatic ring requires a heteroatom for aromaticity, as all the examples utilize benzene. Further, there is no reduction to practice of R21 for a substituent other than hydrogen
Written description issues may arise if the knowledge and level of skill in the art would not have permitted the ordinary artisan to immediately envisage the claimed product arising from the disclosed process (Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not necessarily constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species; MPEP 2162.1(A)).
Further, the criteria for a “representative number of species” to be described requires that the species which are reduced to practice are representative of the entire genus. The description of the conjugates reduced to practice with only a hydrogen for R21 and only a single example of
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attached to the core structure are not representative of the compounds required in the instant claimed conjugates and thus, it cannot be concluded that the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) ("[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.").
Regarding the description of the genus by partial structure combined with a specific function, the specification fails to provide such a correlation. It would be expected that the plethora of different Q groups as in Z3, Z7, and Z8 wherein R in (Z3), (Z7) and (Z8) is selected from hydrogen, C.sub.1-C.sub.24 alkyl groups, C.sub.2-C.sub.24 acyl groups, C.sub.3-C.sub.24 cycloalkyl groups, C.sub.2-C.sub.24 (hetero)aryl groups, C.sub.3-C.sub.24 alkyl(hetero)aryl groups, C.sub.3-C.sub.24 (hetero)arylalkyl groups and C.sub.1-C.sub.24 sulfonyl groups, each of which may optionally be substituted and optionally be interrupted by one or more heteroatoms selected from O, S and NR.sup.32 wherein R.sup.32 is independently selected from the group consisting of hydrogen and C.sub.1-C.sub.4 alkyl groups; R.sup.24 is H or C.sub.1-12 alkyl; R.sup.29 is C.sub.1-12 alkyl would provide conjugates with different properties the drug being delivered with different kinetics under different microenvironmental conditions. It would be expected that the plethora of different R13 group, as in claim 8, hydrogen, C.sub.1-C.sub.24 alkyl groups, C.sub.3-C.sub.24 cycloalkyl groups, C.sub.2-C.sub.24 (hetero)aryl groups, C.sub.3-C.sub.24 alkyl(hetero)aryl groups and C.sub.3-C.sub.24 (hetero)arylalkyl groups, the C.sub.1-C.sub.24 alkyl groups, C.sub.3-C.sub.24 cycloalkyl groups, C.sub.2-C.sub.24 (hetero)aryl groups, C.sub.3-C.sub.24 alkyl(hetero)aryl groups and C.sub.3-C.sub.24 (hetero)arylalkyl groups optionally substituted and optionally interrupted by one or more heteroatoms selected from O, S and NR.sup.14 wherein R.sup.14 is independently selected from the group consisting of hydrogen and C.sub.1-C.sub.4 alkyl groups, or R.sup.13 is a second occurrence of C(O)X connected to N via a spacer moiety would also affect delivery of the exatecan with different kinetics under different microenvironmental conditions. In addition the click probes, Q, in claims 14 and 23, would also affect delivery of the exatecan with different kinetics under different microenvironmental conditions
The compounds described in the specification do not provide a description of all the compounds having the numerous linkers that could be generated from all the variables recited in the instant claims pertaining to the linkers, ,
Thus, the specification fails to provide adequate written description for the genus of compounds claimed and does not reasonably convey to one of skill in the art that he inventors, at the time the application was filed, had possession of the genus of conjugates, methods of making said conjugates and pharmaceutical composition comprising said conjugates.
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)(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 19-22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Chuang et al (WO2021248048, priority to 63/035,175).
Chuang et al disclose the exatecan linker-drug of compound 25 (page 30):
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which meets the limitations of claim 19 wherein L2 is a linker, R17 is the amino acid side chains of valine and citrulline, n is 2; A is a aromatic ring which is a benzene ring; R21 is H. Compound 25 meets the limitation of claim 19 for Q being the click probe DBCO capable of forming an antibody drug conjugate in a metal-free click reaction, the cyclic alkyne moiety in claim 20, Q27 in claim 21(a), Q39 in claim 22, wherein R15 is H, and Y is N.
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.
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 1, 6, 7, 8, 10-13, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Chuang et al (WO2021/248048) in view of Tsai et al (WO2018/126092).
Chuang et al teach the exatecan linker-drug of compound 25 (page 30)
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which meets the limitations of claim 1 wherein L2 is a linker, R17 is the amino acid side chains of valine and citrulline, n is 2; A is a benzene ring; R21 is H. The compound comprises the amino acids of valine and citrulline , and thus meets the limitations of claim 6 for val-cit. Compound 25 meets the limitation of claim 10(ii) for the linker drug construct according to structure 5, wherein L2 is a linker, Q is the click probe DBCO capable of forming an antibodydrug conjugate by a metal-free click reaction between Q and F. Compound 25 meets the limitations of claim 12 for Q27; the limitations of Q39 in claim 13, wherein R15 is H and Y is N.
Chuang et al teach that an antibody comprising an N-glycan binding domain and an N-glycan having the structure
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(paragraph [0006]) is used to attach the linker drug to the antibody (paragraph [0063]):
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. Chuang et al teach that the process for synthesizing the N-glycan, and linker as in the above formula is described by Tsai et al (WO2018/126092) (paragraph [0076])
Tsai et al teach that all naturally occurring IgGs and recombinant antibodies have an amino acid asparagine a position 297 in each of the heavy chain constant regions which is an N-glycosylation site resulting in a di-antenna-shaped glycan moiety (paragraph [0006]):
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Tsai et al teach that the above structure can be modified to a tri-mannosyl core with β-N-acetylglucosaminidase to produce a modified glycoprotein (paragraph [00045], part (i)):
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Tsai et al teach that the above modified glycoprotein comprising the tri-mannosyl core can be further reacted with UDP-GlcNAc-(CH2)0-8-R, in the presence of wherein R is an azido group (page 10, section (ii)):
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folowed by reaction of the “R” with the drug-linker to form the antibody conjugate by means of a click reaction (page 10, section (iii)), and page 13, paragraph [00055]).
Chuang et al teach linker functioanlity of formula (4) (page 12, paragraph [0079]):
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which is commensurate with the product formed by the click reaction cycloaddition between the R group which is azido and the linker drug, represented by compound 25, wherin the azido group is added to the triple bond of the DBCO to form a bi-cycle. Chuang et al teach that compound 25 was reacted with DCBPR2002-4Az to form the antibody-exatecan conjugate and the resultign conjugate had a DAR of 3.77(paragraph [0224]-[0225])
It would have been prima facie obvious to make the antibody-exatecan conjugate using the modified glycan of Tsai et al,
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wherein R is azido. One of skill in he art would have been motivated to do so because Tsaai et al teach the formation of antibody conjugates by reacting the R which is azido with the drug-linker by means of a click reaction with a drug linker, and further because Chaung et al teach the resulting bi-cyclic structure of formula 4. One of skill in the art would understand that DBCO of compound 25 of chaung et al is Q in the conjugate and the ring formed from the cycloaddition of the azido group is “Z”, thus fulfilling the requirement of claim 1 wherein Z is the connecting group obtained by metal-free click reaction, w=1, and based on the measured DAR of 3.77, x is an integer in the range of 1-8. The formation of the above conjugate fulfills the limitations of claim 7 for Z1, the product of the R azido group and DBCO and the limitations of the strcutre of claim 8, (1b), wherein Z is the triazene ring strcutre adducted to DCBO:
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, Su is the modified glycan of Tsai et al, UDP-GlcNAc-(CH2)0-8-R, wherein the R is encoporated into the Z structure; Ge is
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and
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is the glycosylated Asn residue on the antibody. The combined teachings of Chuang et al and Tsai et al also render obvious claims 10-13 and 17 wherein compound 25 meets the limitations of claim 10 section (ii), and it would be obvious that “F”, that the click probe capable of reacting with DBCO in a metal-free click reaction is the azido group of the R moiety on the modified glycan of Tsaid et al which also fulfills the limtiations of claim 17 for “F” being an azide.. The DBCO of compnd 25 meets the limimtations of a cyclic alkyne moiety, Q27 and Q39, wherein R15 is H and Y is N in claims 11-13.
Claims 1-8, 10-13, 17, 18, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Chuang et al and Tsai et al as applied to claims 1, 6, 7, 8, 10-13, 17, and 18 above, and further in view of Van Berkel et al (WO2017/137457) and Nakada et al (Bioorganic and Medicinal Chemistry, 2016, vol. 26, pp. 15421545).
The ccombined teachings of Chuang et al and Tsai et al render obvious claims 1, 6, 7, 8, 10-13, 17, and 18 for the reasons set forth above. Neither Chaung et al nor Tsai et al teach the incorporation of sulfamide into the linkers of an antibody drug conjugate.
Van Berkel et al teach that the incorporation of a sulfamide into the linker of an antiboy-drug conjugate improves the therapeutic index of the antibody-ddrug conjugate (page 5, lines 18-25). Van Berkel et al teach a method of treating breast cancer with the conjugates of the invention (claims 15-18) which meets that limitation in instant claim 27. Van Berkel et al teach the attachement of the linker-drug to the antibody in the same manner as taught by Tsai et al (page 5, lines 3-17), wherein the linker comprises a sulfamide according to formula 1:
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which meets the limitations of claim 4. Van Berkel et al teach linker-drug 65:
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which comprises two groups of formula 1 and meets the limitations of claim 5 With the exception of having an auristatin as the drug, the linker of the linker-drug of Van Berkel meets the limimtiations of the linker to that in instant claims 8(1f), wherein a=1, R13 is hydrogen, L5 is a linker, r=1, p=1, and q=2.
Nakada et al teach that antibody drug conjugates containing exatecan showed good efficacy in a Her2+ and trastuzumab-resistant breast carcinoma mouse model (abstract).
It would have been prima facie obvious a the time of the effective filing date to substitute the exatecan of the conjugate of Chuang et al in place of the auristatin in linker-drug 65 and carry out a click cycloaddition to trastuzumab modified in the method of Tsai et al to carry a glycan derivatized with an azido group, thus obtaining a trastuzumab exatecan conjugate with sulfamide linkers. One of skill in the art would have been motivated to do so because Van Berkel et al teach that the incorporation of sulfamide into the linkers of an antibody drug conjugate increases the therapeutic efficacy of the antibody-drug conjugate and because Nakada et al teach exatecan as a payload for trastuzumab in the treatment of a mouse model of breast cancer . One of skill in the art would have been motivated to admisniter the resulting conjugates having sulfamide in the linker and exateacan as a payload in a mouse model of Her2+, trastuzumab resistant breast cancer. It would be further obvious to provide the antibody exatecan conjugate as a pharmaceutical composition for admisnintration in the mouse model of breast cancer.m thus rendering obvious claim 26.
Claims 2 and 3 are included with this rejection because the scope of the claims is unclear.
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 1-9, 12, and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No.12,440,573. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent anticipate the instant claims.
Claims 1-9, 12, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-9 of copending Application No. 18/892,256 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the application anticipate the instant claims..
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 25 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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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
Prosecution Insights