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 .
Election/Restrictions
Applicant’s election without traverse of Group I and species of anti-FRα antibody which is AB1370049, species of drug conjugate which is a cytotoxin, which is topoisomerase I inhibitor, which is SG3932 and RL is Ia and cancer which is ovarian cancer, in the reply filed on 1/8/2026 is acknowledged.
Examiner’s Comment on Biological Material
Claim 35 requires (optionally) wherein the cancer cell has a similar FRα expression to Igrov-1 cell line. To be able to determine this requires the ability to possess the Igrov-1 cell line. This is a commercially available cell line that is well known as an ovarian carcinoma model (Millipore Sigma, https://www.sigmaaldrich.com/US/en/
product/mm/scc203?msockid=33ae6247ddd966211d92757bdc2c675a, 2026). As such, it is known and readily available. Applicant is put on notice that public access to the cell line during the term of the patent may affect the enforceability of the patent (see MPEP 2404.01).
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: BINDING MOLECULES AGAINST FR[[a]]α
The disclosure is objected to because of the following informalities: On p. 164, line 20, the closed bracket, “]” is missing.
Appropriate correction is required.
The use of the term Biacore, Fortebio, Sigma and Sino Biological, each of which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
While BIACORETM appears on p. 50, line 6, recognition of its trademarked status does not appear in its other locations (e.g., p. 50, lines 14, 61, 27). Fortebio can be found, e.g. p. 50, lines 31 and 33. Sigma (Sigma-Aldrich) appears on p. 50, line 32, and Sino Biological on p. 50, line 35.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFRαmework), hereinafter “Legal framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See p. 137, line 26, and p. 146, line 3, and p. 161, line 30.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
If the sequence(s) is not in the XML Sequence Listing, then the following applies:
This application contains sequence disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.831(a) and 1.831(b). However, this application fails to comply with the requirements of 37 CFR 1.831-1.834. The examiner has noted that amino acid sequence “VVSVLTVLHQDWLNGK” appears on p. 137, line 26, and p. 146, line 3, p. 161, line 30, and “DSTYSLSSTLTLSK” on p. 146, line 3.
Applicant must provide:
• A replacement “Sequence Listing XML” part of the disclosure, as described above in item 1. or 2., as well as
• A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 1.835(b)(3);
• A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• A statement that the “Sequence Listing XML” includes no new matter in accordance with 1.835(b)(5); and
• A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
o A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
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.
Claims 14, 24, 33 and 34 and dependent claims 25 and 35-37 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.
Claim 14 is indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 14 recites the broad recitations of a therapeutic agent, a peptide, a protein, a biological response modifier and a pharmaceutical agent, and the claim also recites a cytotoxin an antimicrobial agent, a prodrug, an enzyme, a lipid, a lymphokine, a heterologous antibody or fragment thereof, a detectable label, a PEG and a radioisotope which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 24 recites the limitation "the drug to antibody ratio" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1, from which claim 24 depends, does not recite a drug. This claim could, for example, instead depend from claim 16.
Claim 33 is indefinite for two reasons. First, it is unclear what the method is of or for. The preamble simply recites “A method comprising,…” Second, there is no recitation that any product is administered in an effective amount or a therapeutically effective amount (see p. 116, lines 23-27) for depletion of a population of FRα-positive cells in the subject. This is important because if the antibody or antigen binding fragment thereof is not administered in an effective amount for the required depletion, then something else which is not recited must be. Without clarifying if the antibody or antigen-binding fragment thereof is the product producing the effect, the metes and bounds of the claims cannot be determined.
Claim 34 is indefinite because it is unclear what is encompassed by a “a cancer associated with FRα expression”. The specification discloses that FRα-positive cells can be depleted by administering the claimed antibody, and that “Typically, the FRα-positive cells are FRα-positive cancer cells.” (p. 12, lines 7-12) However, the specification does not define what it means to have a cancer “associated with” the expression. Therefore, the metes and bounds of the claim are not clear.
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.
Claim 10 is 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.
Claim 10 is drawn to the antibody or antigen-binding fragment thereof according to claim 1 and which is humanized, chimeric or fully human. The lead antibodies of the instant claims are based on those disclosed in the specification which were produced by immunization of humanized Del-1 mice, resulting in the production of fully human antibodies (p. 123, lines 16-19 and lines 29-30). The specification defines a “humanized antibody” as one in which the framework or CDRs have been modified to comprise the CDR of an immunoglobulin (Ig) of a different specificity compared to the parent Ig. The example given is an antibody comprising murine CDRs surrounded by human framework region. There is only generic disclosure of a humanized antibody without any description as to what modifications in the 6 disclosed antibodies could be made to produce a functional humanized FRα antibody. That is, for example, what mouse CDRs could replace the human CDRs and function in the context of the current disclosed framework regions. This is different than a “chimeric antibody”, defined as one with a variable region from one source or species and at least a portion of the constant region from another source or species. The skilled artisan could readily envision a genus of chimeric anti-FRα antibodies comprising the human variable regions and, for example, mouse Fc region. However, a humanized antibody does not meet the written description provision of 35 USC 112(a).
Chiu et al. (2019) reviewed humanization of antibodies, describing the multiple steps needed to analyze amino acid sequences to determine potential functional impact of amino acid substitutions. One method of humanization is CDR grafting, which requires identifying compatible CDR/framework region sets. Chiu et al. (p. 12, second third paragraph) notes that, “[A]bout 20% of residues that bind the antigen fall outside the CDRs [106,107].” The framework region set in combination with the CDRs must produce an antibody or antigen-binding fragment thereof with sufficient activity. There are multiple sequences of human and mouse germline framework region sets, and while the human and mouse sequences are largely conserved, one must find an appropriate set out of the many possibilities and then one or more back mutations to the parent sequence may be required for function (p. 15, first full paragraph). The specification discloses 6 anti-FRα antibodies, each with different CDRs and framework sequence sets. The skilled artisan cannot immediately envisage other CDRs or framework region sets that could be substituted in the disclosed antibodies to produce a functional humanized anti-FRα antibody. It does not appear the inventors were in possession of the genus of humanized antibodies claimed.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111 (Fed. Cir. 1991), clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116).
Therefore, only wherein the antibody or antigen-binding fragment thereof of claim 10 is a chimeric or human antibody but not the full breadth of the claim meets the written description provision of 35 U.S.C. § 112(a). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 33-37 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 a method of depleting a population of FRα-positive cells or treating cancer expressing FRα in a subject comprising: administering the anti-FRα antibody or antigen-binding fragment thereof of claim 1 conjugated to a cytotoxic agent to the subject in an amount effective to deplete the cells or treat the cancer, does not reasonably provide enablement for wherein the antibody is not in an effective amount and not conjugated to a cytotoxic agent and wherein the cancer does not express FRα and is not administered to a subject in need thereof, i.e., comprising cancer cells expressing FRα. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Claim 33 is drawn to a method comprising administering the anti-FRα antibody or antigen-binding fragment thereof according to claim 1 to a subject resulting in depletion of a population of FRα-positive cells in the subject. Claim 34 is drawn to a method comprising administering the anti-FRα antibody or antigen-binding fragment thereof according to claim 1 to treat a cancer associated with FRα expression. Claim 34 fails to address the context of the “association” of the cancer with FRα expression. It is noted that dependent claims 35-37 are limited to wherein the cancer comprises cancer cells having heterogenous expression of FRα and/or a low expression of FR, but claim 34 only requires treating “a cancer associated with FRα expression”. Dependent claims 36-37 limit the cancer to particular types. All claims fail to address the amount of anti-FRα antibody or antigen-binding fragment thereof that is being administered. The claims additionally only require administration of the naked, i.e., unconjugated, antibody.
The specification shows all 6 lead antibodies internalize upon binding a cell having high expression of FRα (Example 3, KB cells, see p. 13, lines 27-29). There is no working example wherein the naked antibody produces any killing or reduction in proliferation of a cell. It is discussed in BACKGROUND of the specification that in the prior art, anti-FRα antibody-drug conjugates have been made and applied to killing cancer cells. It reasonably appears that internalization of an anti-FRα antibody per se is not sufficient for treatment of a cancer, regardless of FRα expression by the cancer cells, or killing an FRα-positive cell. What the instant specification and prior art has shown is that an antibody-drug conjugate (ADC) can kill cells, particularly cancer cells, when those cells express FRα (Examples 18-20 and 22-24) or wherein they do not themselves express FRα but are very near FRα-expressing cells, i.e., are bystander cells (see Example 17). There is no support for treatment of a cancer that does not have at least some cells that express FRα. Nor is there support for the breadth of possible drugs used in an ADC as, for example, set forth in claim 14 for treatment of cancer or depletion of FRα-positive cells. There is no evidence or reasonable expectation based on the instant specification or prior art that, for example, an antimicrobial agent, an enzyme or a lipid conjugated to one of the disclosed anti-FRα antibodies could be used to treat cancer or deplete FRα-positive cells. As discussed in the BACKGROUND of the specification, the prior art supports cytotoxic drugs, e.g., a microtubule inhibitor, conjugated to an anti-FRα antibody for cell killing, albeit with significant adverse side-effects when administered in vivo (paragraph bridging pp. 2-3). The only working examples in the specification showing treatment of cancer or cytotoxicity of cells is in in vitro and in animal models wherein administration is with anti-FRα AB1370049-SG3932 DAR4 and DAR8, which is an ADC with the drug being topoisomerase inhibitor (TOPOi) SG3932 and having 4 or 8 of the TOPOi. The specification does not provide direction or guidance for treatment of cancer or killing FRα-positive cells without an ADC or wherein the drug is not cytotoxic. The method of anticancer activity disclosed appears to be internalization of a cytotoxic agent, where the agent then becomes actively cytotoxic. If either there was no drug or it was not cytotoxic, the skilled artisan would not have reasonably expected any level of treatment or depletion as required by the instant claims. It reasonably follows that if the antibody or antigen-binding fragment thereof cannot bind a cancer cell, it cannot deliver the cytotoxic agent into the cell, wherein it becomes cytotoxic or cytostatic. As discussed in the last paragraph of p. 54:
The antibody linked to a heterologous agent (e.g. ADC) is preferably stable and intact before being transported or delivered into a cell, i.e. the antibody should be attached to the drug moiety. Outside the target cell, the linkers are stable, but inside the cell, they can be cleaved at a high rate. An effective linker will: (i) maintain the antibody's specific binding properties; (ii) allow intracellular delivery of the conjugate or drug moiety; (iii) remain stable and intact, i.e. not cleaved, until the conjugate has been delivered or transported to its targeted site; and (iv) maintain the cytotoxic moiety's cell-killing or cytostatic effect.
Therefore, in order for one skilled in the art to be able to use the instant invention for depletion of FRα-positive cells or treatment of cancer, (i) the cancer must have cells that express-FRα, thereby allowing binding of the antibody or antigen-binding fragment thereof to bind cancer cells, (ii) the antibody or antigen-binding fragment thereof must be conjugated to a cytotoxic agent, thereby providing the means to kill the cancer cells or deplete a population of FRα-positive cells, and (iii) be administered in an amount sufficient for cytotoxicity. As the claims are currently written, it would require undue experimentation to practice the methods commensurate in scope with the claims.
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 1-20, 22-26 and 32-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 69-71, 76, 78, 81, 83, 84, 86, 88, 91, 115, 120 and 122 of copending Application No. 18/845,835 (‘835, reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
Instant claims 1-20 and 22-26 and 32 are drawn to an anti-FRα antibody or antigen binding fragment thereof, comprising the variable heavy and variable light chain region (VH and VL, respectively) of SEQ ID NO:37/38, 39/40,41/42, 43/44, 45/46 and 47/48, or comprising the 6 CDRs thereof, and further wherein the antibody is part of an antibody-drug conjugate (ADC) with conjugation to a cytotoxin (claims 13-19, 26 and presumable claims 24-25), including wherein the cytotoxin is a topoisomerase 1 inhibitor (claims 20, 22, 23, e.g., SG3932). Instant claims 33-37 are drawn to a method of depleting FRα-positive cells or treating cancer by administering the anti-FRα antibody or antigen-binding fragment thereof.
The claims of ‘835 are principally drawn to a method of identifying a cancer patient for treatment with an ADC targeting FRα. Claim 71 recites administering a therapy involving the ADC to the cancer patient identified as likely to benefit from said administration. Dependent claims limit the antibody or antigen-binding fragment thereof of the ADC to one of those of the instant claims (claims 76, 88, 91 and 120 of ‘835) and also to an ADC wherein the drug is a cytotoxin, a topoisomerase I inhibitor, specifically SG3932 (claims 81, 83, 84 91 and 120), thereby anticipating the instant claims. Wherein the antigen-binding fragment comprises the VH and VL (e.g., claim 76) makes obvious wherein the antigen-binding fragment is a Fab, Fab’ or F(ab’)2 (instant claim 9). Claim 86 specifies the ADC drug-to-antibody ratio (corresponding to instant claims 24-25). Claims 78 and 122 recite the types of cancer to be treated (corresponding to instant claims 36-37). Claims 76 and 120 specify the antibody is a humanized IgG1 monoclonal antibody (corresponding to instant claims 10-12).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20, 22-26 and 32-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-33 of copending Application No. 19,158,097 (‘097, reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because
The instant claims 1-20 and 22-26 and 32 are drawn to an anti-FRα antibody or antigen binding fragment thereof, comprising the variable heavy and variable light chain region (VH and VL, respectively) of SEQ ID NO:37/38, 39/40,41/42, 43/44, 45/46 and 47/48, or comprises the CDRs thereof, and further wherein the antibody is part of an antibody-drug conjugate (ADC) with conjugation to a cytotoxin (claims 13-19, 26 and presumable claims 24-25), including wherein the cytotoxin is a topoisomerase 1 inhibitor (claims 20, 22, 23, e.g., SG3932). Instant claims 33-37 are drawn to a method of depleting FRα-positive cells or treating cancer by administering the anti-FRα antibody or antigen-binding fragment thereof.
The claims of ‘097 are drawn to a method of treating cancer in a subject in need thereof comprising administering an ACD comprising an anti-FRα antibody or antigen-binding fragment thereof linked to a cytotoxin and administration of a PARP1 inhibitor. Dependent claims limit the antibody to one of those of the instant claims (claims 7-15 and 31-32 of ‘097), including wherein the fragment is a Fab and antibody is fully human and monoclonal or recombinant and an IgG1 type (claims 16-19 of ‘097, corresponding to instant claims 9-12). The ADC drug and linker are further limited as set forth in claims 20-27 and 31-32 (corresponding to instant claims 16-20 and 22-23), wherein the drug is a cytotoxin, a topoisomerase I inhibitor, specifically SG3932. Claims 28-30 specify the ADC drug-to-antibody ratio (corresponding to instant claims 24-25). Claims 3-4 recite the types of cancer to be treated (corresponding to instant claims 36-37). Claims 76 and 120 specify the antibody is a humanized IgG1 monoclonal antibody (corresponding to instant claims 10-12). The use of the ADC anticipates the both the antibody and ADC of which it is a part.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Prior Art
The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure.
The non-patent literature references cited in the IDS filed 6/15/2023 all disclose anti-FRα antibody ADCs. They support the need for an anti-FRα antibody to be part of a cytotoxic ADC in order to be used for treatment of cancer or depletion of FRα-positive cells.
Reddy et al. (Sci. Rep. 8:8943, 10 pages, Jun. 2018, Abstract) teaches a ligand-drug conjugate comprising folate conjugated to tubulysin. Treatment of mice with FR-positive human xenografts let to 100% cure rate. Also, treatment of FR-positive human tumor xenograft models with confirmed resistance to folate-vinca alkaloid, cisplatin or paclitaxel let to partial curative responses. This reference shows that folate (the FRα ligand) instead of a FRα antibody in a drug conjugate also leads to cytotoxicity of FR-positive cancer cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Claire Kaufman, whose telephone number is (571) 272-0873. Examiner Kaufman can generally be reached Monday through Friday 7am-3:30pm, Eastern Time.
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Claire Kaufman
/Claire Kaufman/
Primary Examiner, Art Unit 1674
April 20, 2026
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