DETAILED ACTION
Notice of 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 .
Priority
The earliest effective filing date afforded the instantly claimed invention has been determined to be 5/09/2018, the filing date of provisional Application 62/669,034. The instant Application is not afforded the priority of application 15/806,197 (now U.S. Patent No. 10,711,032), of which this Application is a Continuation-in-Part and which does not provide support for the instantly claimed compounds.
Election/Restrictions
Applicant’s election without specifying traverse of Group I in the reply filed on 6/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement is still deemed proper and is therefore made FINAL.
Claims 36, 63 and 68-73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without specifying traverse of a single species in the reply filed on 6/23/2026 is also acknowledged.
Applicant indicates that “[a]t least claims 1, 63, and 65-67 read on the elected species” (Applicant Arguments, Page 57).
However, claims 65-66 are drawn to a linker-payload comprising the compound of claim 37, and claim 67 is drawn to an antibody-drug conjugate comprising the compound of claim 38, neither of which are indicated as reading on the elected compound species.
Applicant is requested to more clearly identify each of the elements recited by claim 1 within the chemical structure of the elected compound species. In particular, Applicant is requested to identify with specificity each of the binding agent, the payload, the hydrophilic residue, and the covalent linker(s) bonded directly/indirectly to each of said binding agent, payload moiety, and hydrophilic residue.
Furthermore, Applicant is requested to similarly identify each of the elements recited by claims 37 and 38 within the chemical structure of the elected compound species. In particular, Applicant is requested to identify with specificity each of the reactive linker, the payload moiety, the hydrophilic residue, and the covalent linker(s) bonded directly/indirectly to each of said reactive linker, payload moiety, and hydrophilic residue as recited by claim 37; and each of RG’, L, PA, and HL as recited by claim 38.
Currently, claims 1 and 65-67 are believed to read on the elected species. Claims 37-42, 44, and 62 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
Applicant’s elected species:
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reads on claims 1 and 65-67.
The elected species has been searched and is deemed to be free of the prior art and non-obvious.
Lhospice et al (Molecular Pharmaceutics, 12:1863-1871, 2015) is considered representative of the closest prior art. In particular, Lhospice et al teach antibody drug conjugates as follows:
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as well as the following related linkers:
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Although it would have been obvious to formulate antibody drug conjugates based on aminocaproyl-vc-MMAE in view of Lhospice et al, there is no obvious reason to further modify the resulting compound in the following two ways to arrive at the instantly claimed compounds:
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(1) by adding an RG2 group, an SP2 group, and an HG group to the indicated NH2; and
(2) by adding the SP1 and R1 groups to the indicated CH2.
And since Applicant’s elected species contains written support and is enabled, the elected species is considered to be ALLOWABLE.
Accordingly, the search was expanded as called for under current Office Markush practice – a compound-by-compound search – to include a single additional species (M.P.E.P. § 803.02). That species is the antibody-drug conjugate mAb-sulfo-SPDB-DM4:
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which entails a compound comprising a binding agent linked to at least one payload moiety and linked to at least one hydrophilic residue via a covalent linker, and which further reads on claims 65-67, all of which are rejected below.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 65-67 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement.
The claims contain 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, at the time the application was filed, had possession of the claimed invention. In particular, support cannot be found for the compounds as recited by claims 1 and 65-67 (which include compounds of Formula (VI))as instantly claimed.
The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, “not a mere wish or plan for obtaining the claimed chemical invention.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.”
In the instant case, it is evident that the genus of compounds embraced by claim 1, including those embraced by Formula (VI), has substantial variance. Indeed, even the genus of compounds embraced by Formula (VI) is virtually without limit, embracing hundreds of millions of potential compounds bearing no structural resemblance to one another what-so-ever, comprising any “reactive group” RG’, any trivalent linker “L”, any hydrophilic residue “HL” and any payload moiety “PA”. Yet, the instant Specification discloses compounds exhibiting limited structural diversity, in particular wherein each of RG’, L, HL and PA are highly conserved.
While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of a group of structurally related compounds does not adequately describe a subgenus embracing hundreds of millions of additional compound species bearing no structural relationship with those disclosed compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
As such, claims 1 and 65-67 are rejected.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 65-67 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (Molecules 22:1281, published 8/01/2017).
Claim 1 is drawn to a compound comprising a binding agent linked to at least one payload moiety and linked to at least one hydrophilic residue via a covalent linker, wherein:
the said covalent linker is bonded directly or indirectly to each of the binding agent, the payload moiety, and the hydrophilic residue; and
the hydrophilic residue comprises a sulfonic group.
Chen et al teach the antibody-drug conjugate mAb-sulfo-SPDB-DM4 (Page 11, Scheme 4(A)) which reads on the instantly claimed compound as follows:
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Accordingly, claim 1 is anticipated.
Claims 65-66 are drawn to a linker-payload comprising the compound of claim 37, bonded to a linker, wherein claim 37 is drawn to a compound comprising a reactive linker bonded to at least one payload moiety and bonded to at least one hydrophilic residue via a covalent linker, wherein:
said covalent linker is bonded directly or indirectly to each of the reactive linker, the payload moiety, and the hydrophilic residue; and
the hydrophilic residue comprises a sulfonic group.
The antibody-drug conjugate mAb-sulfo-SPDB-DM4 taught by Chen et al (Page 11, Scheme 4(A)) reads on claims 65-66 wherein the reactive linker is SPDB, the payload moiety is DM4, and the hydrophilic residue is sulfonic acid, each of which is directly bonded via covalent linker (as recited by claim 37), and wherein the linker (of claim 65) is NH2 and wherein the compound is bonded to an oxygen or a primary or secondary nitrogen of the payload (as recited by claim 66).
Accordingly, claims 65-66 are also anticipated.
Claim 67 is drawn to an antibody-drug conjugate comprising the compound of claim 38 bonded to an antibody, wherein claim 38 is drawn to a compound of Formula (VI):
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wherein RG’is a reactive group NH2; L is a trivalent linker; HL is a hydrophilic residue; and PA is a payload.
The antibody-drug conjugate mAb-sulfo-SPDB-DM4 taught by Chen et al (Page 11, Scheme 4(A)) reads on claim 67 wherein the reactive linker is SPDB, the payload moiety is DM4, and the hydrophilic residue is sulfonic acid, each of which is directly bonded via covalent linker, and wherein the linker is NH2 (as recited by claim 38) which is bonded to an antibody (as recited by claim 67).
Accordingly, claim 67 is also anticipated.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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.
Claims 1 and 65-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent No. 12,134,631.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘631 claims are drawn to antibody drug conjugates which read on claims 1 and 65-67 such as, for example:
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(claim 19).
Claims 1 and 65-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent No. 12,209,180.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘180 claims are drawn antibody drug conjugates which read on claims 1 and 65-67 such as, for example:
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(claim 36).
Claims 1 and 65-67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent No. 12/338,199.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘199 claims are drawn to antibody drug conjugates which read on claims 1 and 65-67 such as, for example:
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(claim 3).
Claims 1 and 65-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of US Patent No. 12,497,460.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘460 claims are drawn to antibody drug conjugates which read on claims 1 and 65-67 such as, for example:
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(claim 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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