DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 07/02/2024 is acknowledged and the references cited therein have been considered.
Priority
3. The present application claims the benefit of US Provisional Patent Application No. 63/380,514, filed 10/21/2022. Applicant' s claim for the benefit of prior-filed application is acknowledged.
Status of Claims
4. Claims 62-87 are pending in the instant application.
5. Applicant’s election of Group I, claims 68-82, without traverse, is acknowledged, which is directed to a method of providing a cytotoxic effect against a FOLR1-expressing cancer cell. Additionally, applicant elected species of Farletuzumab and the CDRs of SEQ ID NOs: 385-390, VH of SEQ ID NO: 391, and VL of SEQ ID NO: 392 are acknowledged and under consideration.
6. Claims 83-87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions.
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.
7. Claim 74 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The instant claim 74 is rejected for the recitation “Farletuzumab or a binding fragment thereof”, because FC is a binding fragment of the antibody, but Fc is a binding fragment of Farletuzumab. It is unclear if this “binding fragment thereof” refers to any antibody fragment such as Fc fragment which binds Fc receptors or is limited to fragments containing the antigen-binding domain of the antibody.
The instant claim 74 is ambiguous for the recitation “and or” in the last line. It is unclear whether the applicant is claiming the combination of antibodies, individual antibodies, or both.
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.
8. Claims 68-82 are 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.
The instant claims are drawn to a genus of polypeptide conjugates comprising a broad genus of binding domain that binds folate receptor 1 (FOLR1) wherein the binding domain is linked to hemiasterlin (claim 68) or ‘linked to a therapeutic agent’ (claim 77).
Dependent claim 69 is dependent on 68 and encompasses that the CDRs are the CDRs of Farletuzumab.
Dependent claim 70 encompasses the CDRs of the binding domain that binds FOLR1.
Dependent claim 71 encompasses the payload of the conjugate, which is a 3-aminophenyl hemiasterlin.
Dependent claim 72 specifies that the payload is a cleavable 3-aminophenyl hemiasterlin.
Dependent claim 73 encompasses the linker of the conjugate, which is a cleavable valine citrulline p-aminobenzylcarbamate linker functionalized with dibenzocyclotyne (DBCO).
Dependent claim 74 depends from claim 68 and encompasses that that binding domain comprises Farletuzumab or a binding fragment thereof.
Dependent claim 75 encompasses a subgenus of binding fragments where the fragment comprises a single chain variable fragment (scFv).
Dependent claim 76 encompasses the method of claim 75, wherein the scFv comprises a Farletuzumab scFv.
Claim 68 and 77, given broadest reasonable interpretation consistent with the specification, read on a genus of binding domains which bind folate receptor 1 (FOLR1). Moreover, the broadest claim (claim 68) does not indicate any specific structure for the binding domains/antibodies nor does it indicate any specific antigen where the antibody would bind nor where upon it they would bind.
The USPTO has released a Memo on the Clarification of Written Description Guidance For Claims Drawn to Antibodies and Status of 2008 Training Materials, 02/22/2018.
See https://www.uspto.gov/sites/default/files/documents/amgen_22feb2018.pdf.
The Memo clarifies the applicability of USPTO guidance regarding the written description requirement of 35 U.S.C. § 112(a) concerning the written description requirement for claims drawn to antibodies, including the following.
“In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional”.
There is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed FOLR1 antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, 124 USPQ2d 1354 (Fed. Cir. 2017).
There is no evidence that knowledge of the chemical structure of an antigen gives the required kind of structure identifying information about the corresponding antibodies Applicants attempt to describe the invention by describing something that is not the invention: viz., the antigens to which the antibodies may bind. There nothing in the disclosure that describes the antibodies as required by the test set forth in Ariad.
However, the FOLR1 binding domains/antibodies are required to practice the invention. The specification also fails to provide any specific structural or physical information so as to define a genus of antibodies having the desired therapeutic properties. Applicant is merely relying on the identification of FOLR1 as the antigen and the well-known structure of antibodies in general. However, the claims do not recite a general antibody, but an antibody having a specific desired activity. However, Federal Circuit clarification of the law of written description as it applies to antibodies. Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017).
The claims are directed to a genus of FOLR1 binding domains/antibodies. However, Federal Circuit clarification of the law of written description as it applies to antibodies. The U.S. Court of Appeals for the Federal Circuit (Federal Circuit) decided Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), which concerned adequate written description for claims drawn to antibodies. The Federal Circuit explained in Amgen that when an antibody is claimed, 35 U.S.C. § 112(a) requires adequate written description of the antibody itself. Amgen, 872 F.3d at 1378-79. The Amgen court expressly stated that the so-called "newly characterized antigen" test, which had been based on an example in USPTO-issued training materials and was noted in dicta in several earlier Federal Circuit decisions, should not be used in determining whether there is adequate written description under 35 U.S.C. § 112(a) for a claim drawn to an antibody. Citing its decision in Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., the court also stressed that the "newly characterized antigen" test could not stand because it contradicted the quid pro quo of the patent system whereby one must describe an invention in order to obtain a patent. Amgen, 872 F.3d at 1378-79, quoting Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1345 (Fed. Cir. 2010). In view of the Amgen decision, adequate written description of a newly characterized antigen alone should not be considered adequate written description of a claimed antibody to that newly characterized antigen, even when preparation of such an antibody is routine and conventional.
Moreover, there is insufficient written description of the required kind of structure-identifying information about the corresponding makeup of the claimed FOLR1 binding domains/antibodies to demonstrate possession. Also, see Amgen Inc. v. Sanofi, Aventisub LLC, No. 2017-1480 (Fed. Cir. 2017). The Court reiterated that adequate written description must “contain enough information about the actual makeup of the claimed products . . . .” The Court simultaneously suggested that the “newly characterized antigen” test “flouts” section 112 because it “allows patentees to claim antibodies by describing something that is not the invention, i.e. the antigen.” The Court concluded that for written description of an antibody to be adequate when presented with “functional” terminology, there must be an established correlation in the art between structure and function.
Given the broadly claimed class of antibodies and in the absence of sufficient disclosure of relevant identifying characteristics for the broadly claimed class of binding domains/antibodies to FOLR1, the patentee must establish “a reasonable structure-function correlation” either within the specification or by reference to the knowledge of one skilled in the art with functional claims AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc. (Fed. Cir. 2014), MPEP 2163.
Given the well-known high level of polymorphism of antibodies, the skilled artisan would not have been in possession of the vast repertoire of antibodies and the unlimited number of antibodies encompassed by the claimed invention; one of skill in the art would conclude that applicant was not in possession of the structural attributes of a representative number of species possessed by the members of the genus of antibodies encompassed in the claims at the time the instant application was filed.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear 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.). Consequently, Applicant was not in possession of the instant claimed invention. See University of California v. Eli Lilly and Co. 43 USPQ2d 1398.
Applicant is invited to point to clear support or specific examples of the claimed invention in the specification as-filed.
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)(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.
(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.
9. Claim(s) 68 and 77-78 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/055909 (Stafford et al., Pub Date 03/21/2019, IDS Reference).
The ‘909 publication teaches a method of providing a cytotoxic effect against a FOLR1-expressing cancer cell comprising contacting the FOLR1-expressing cancer cell with a binding domain that binds FOLR1, wherein the binding domain is linked to hemiasterlin thereby providing the cytotoxic effect against the FOLR1-expressing cancer cell. (see Example 12 paragraphs [571] and [572], Conjugate P used for in vitro cell killing on FolRa-positive cells).
Claim 77 is included because the ‘909 publication also teaches that acute myeloid leukemia (AML) may be treated with the antibody conjugates provided therein. (see paragraph [532]). Thus, the ‘909 publication teaches a method of providing a cytotoxic effect against an acute myeloid leukemia cell wherein the method comprises contacting the AML cell with a FOLR1 binding domain linked to a therapeutic agent thereby providing the cytotoxic effect against the acute myeloid leukemia cell.
Claim 78 is included because it is inherent based on the teaching of the ‘909 publication that Conjugate P could be used as a potential treatment for AML. Thus the ‘909 teaches the method of claim 77 wherein the therapeutic agent comprises hemiasterlin.
The reference teachings anticipate the instant claims.
10. Claim(s) 68 -70, 74 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US Pat. 12178879.
The `879 patent teaches and claims antibody-drug conjugates formed of the hemiasterlin derivatives and antibodies exhibit cytotoxic activity specifically to antigen-expressing cells and have low cytotoxicity in normal cells other than the antigen-expressing cells, and therefore, can be anticancer agents excellent in safety (col. 9, lines 13+, col., 18, lines 61+). The `879 patent provides an antibody-drug conjugate formed of a hemiasterlin derivative and an antibody and represented by formula (2) exhibits strong antitumor activity and has low cytotoxicity to normal cells, and that a hemiasterlin derivative represented by formula (1) is useful as a synthetic intermediate of the antibody-drug conjugate represented by formula (2), thereby completing the present invention, wherein mAb is farletuzumab (comprising the claimed CDRs of SEQ ID NOs:385-390, VH of SEQ ID NO: 391, and VL of SEQ ID NO: 392) (see claims 1-14 and col., 2-6, under Solution to Problem, col., 13, lines 38+). The `879 patent teaches antibody-drug conjugates are conjugates formed by conjugating an antibody and a drug directly or via an appropriate linker (col., 1, lines 24+), wherein cancer is leukemia (claim 14, col., 8, line 46, col.,39, line 48).
The reference teachings anticipate the instant claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
11. Claim(s) 68-76 are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. (Annals of Oncology, Vol. 31 Supplement 1, March 2020, pp. S5-S6, “Sato”) in view of Li et al. (Cancer Res., 2018, 78, 13_Supplement: pg. 1782, “Li”)
Sato teaches MORAb-202 (farletuzumab paired with a cathepsin B-cleavable linker to eribulin) as a treatment for folate receptor alpha (FOLR1)-positive solid tumors.
Sato does not teach a hemiasterlin payload linked to the farletuzumab binding domain.
However, in analogous art, Li teaches STRO-002, a novel antibody drug conjugate (ADC) combining an anti-FOLR1 human IgG1 antibody (SP8166) with the proprietary drug-linker payload SC239. SC239 contains a tubulin targeting 3-aminophenyl hemiasterlin warhead (SC209), and is conjugated via a cleavable valine citrulline p-aminobenzyl carbamate linker functionalized with dibenzocyclotyne (DBCO).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to substitute the SC239 linker/payload of Li onto the farletuzumab antibody of Sato as a treatment for FOLR1-positive cancer.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because the tubulin-targeting 3-aminophenyl hemiasterlin warhead, SC209, has potent cytotoxic activity and is a weak substrate for efflux pumps.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
12. Claims 77-82 are rejected under 35 U.S.C. 103 as being unpatentable over Sato et al. (Annals of Oncology, Vol. 31 Supplement 1, March 2020, pp. S5-S6, “Sato”) in view of Li et al. (Cancer Res., 2018, 78, 13_Supplement: pg. 1782, “Li”), further in view of WO 2019/055909 (Stafford et al., Pub Date 03/21/2019, IDS Reference).
The teachings Sato have been discussed, supra.
The teachings of Li have been discussed, supra.
Neither Sato nor Li teach a method for providing a cytotoxic effect against an acute myeloid leukemia (AML) cell.
The ‘909 publication teaches that a FOLR1-targeted ADC could be used to treat AML. (see paragraph [532]).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the farletuzumab antibody of Sato with the SC239 linker/payload of Li to treat AML as taught by the ‘909 publication.
One of ordinary skill in the art at the time the invention was made would have been motivated to do so because acute myeloid leukemia (AML) cells express FOLR1.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
13. Claims 71-73 and 75-82 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 12178879, in view of Li et al. (Cancer Res., 2018, 78, 13_Supplement: pg. 1782, “Li”), further in view of WO 2019/055909 (Stafford et al., Pub Date 03/21/2019, IDS Reference).
The teachings of the ‘879 patent have been discussed, supra.
The teachings of Li have been discussed, supra.
The teachings of the ‘909 publication have been discussed, supra.
The ‘879 patent teaches farletuzumab with hemiasterlin, but does not teach a 3-aminophenyl hemiasterlin, nor does it teach a cleavable hemiasterlin, nor does it teach a cleavable hemiasterlin conjugated to the FOLR1 binding domain with a cleavable valine citrulline p-aminobenzyl carbamate linker functionalized with dibenzocyclotyne (DBCO). Furthermore, the ‘879 patent does not specifically teach acute myeloid leukemia (AML) as a disease treated with the conjugate.
However, in analogous art, Li teaches the SC239 linker/payload and the ‘909 publication specifically teaches AML as a disease to be treated.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the farletuzumab of the ‘879 patent with the SC239 linker/payload of Li, and also be able to induce a cytotoxic effect to an AML cell since AML is taught by the ‘909 publication.
One of ordinary skill in the art would be motivated to do so because SC209 (the payload of SC239) has potent cytotoxicity and is a weak substrate for drug efflux pumps, and AML cells express FOLR1.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
14. Claims 68, 71-73, and 77-81 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 64-65, 67-70, and 87 of copending Application No. 18/491,656 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claim 1 claims a method of treating acute myeloid leukemia with an antibody conjugate that specifically binds FOLR1 and is linked site-specifically to at least one payload moiety. The reference claims 64 and 65 name hemiasterlins and hemiasterlin as a potential payload moiety, and reference claims 68, 69, and 70 specify that the payload is a 3-aminophenyl hemiasterlin payload conjugated to the antibody with a cleavable valine citrulline p-aminobenzyl carbamate linker functionalized with dibenzocyclotyne (DBCO). Reference claim 87 depends from the method of claim 1, and recites that the antibody can be monoclonal or an antibody fragment. These are patentably indistinct from the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
15. No claims are allowed.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALAN ALFANO whose telephone number is (571)272-3092. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALAN ALFANO/ Examiner, Art Unit 1641
/MAHER M HADDAD/Primary Examiner, Art Unit 1641
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