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 .
DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/12/2025 has been entered. Claims 1, 8, 14-17, 22, and 45 were amended and claims 23-27 were canceled.
Claims 1, 4-5, 8-17, 22, 30-31, 33-34, 36-45, and 92-95 are pending in the instant application.
Priority
This application is a 371 of PCT/US2019/051350, filed on 9/16/2019 which claims priority to the provisional application 62732423 filed on 9/17/2018.
Election/Restriction
Claims 1, 4-5, 8-13, 17, 30-31, 33-34, 36-43, and 92-95 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 9, 12-13, 15, 24-25, 27, and 39-43, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 8/28/2024 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims …
Claims 1, 4-5, 8-17, 22, 30-31, 33-34, 36-45, and 92-95 are examined herein.
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 22 and 45 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 22
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 22 recites the broad recitation “p-(azidomethyl)-phenylalanine” and the claim also recites “p-(azidomethyl)-L-phenylalanine” which is the narrower statement of the range/limitation. The claim is 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. Based on the Response to Arguments mailed on 5/12/2025, it appears this is likely a typo and Applicant wished to claim “p-(azidomethyl)-phenylalanine” and “p-(azido)-phenylalanine” as shown below.
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Claim 45
Claim 45 is drawn to “the kit of claim 1 …comprising a pharmaceutically acceptable carrier administered to a subject”. Claim 45 is a product claim that appears to be reciting a method step of “administer[ing]” said product. MPEP § 2173.05(p) (II) recites:
“Product and Process in the Same Claim
“A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages…to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318, 97 USPQ2d at 1749 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384, 77 USPQ2d 1140, 1145 (Fed. Cir. 2005)”.
In the instant case, because the claimed product (i.e. kit of claim 1) includes a step of using it (i.e. “administered”), this claim is rendered indefinite.
Claim Rejections – 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14-16 and 44 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14
Claim 14 is drawn to the anti-FOLR1 antibody of claim 1, optionally comprising the HCDRs of instant SEQ ID NOs: 58, 176, and 294. Because claim 1 already requires the anti-FOLR1 antibody to comprise this set of CDRs, this subset of options fails to limit the scope of parent claim 1. Examiner recommends canceling this claim, unless they are trying to claim the antibody contains a second set of HCDRs that comprise instant SEQ ID NOs: 117, 235, and 294.
Claim 15
Claim 15 is drawn to the anti-FOLR1 antibody of claim 1, optionally comprising the LCDRs of instant SEQ ID NOs: 299, 302, and 305. Because claim 1 already requires the anti-FOLR1 antibody to comprise this set of CDRs, this limitation fails to further limit the scope of parent claim 1.
Claim 16
Claim 16 is drawn to the anti-FOLR1 antibody of claim 1, optionally comprising the VH of SEQ ID NO: 362 and the VL of SEQ ID NO: 367. Because claim 1 already requires the anti-FOLR1 antibody to comprise this set of CDRs, this limitation fails to further limit the scope of parent claim 1. Applicant is encouraged to claim the complete set of six CDRs for the anti-FOLR1 antibody in parent claim 1 (as opposed to the VH and VL regions), which is an antibody comprising SEQ ID NOs: 58, 176, 294, 299, 302, and 305; then claim the VH of SEQ ID NO: 362 in one child claim, and then claim the VL of SEQ ID NO: 367 in another child claim.
Claim 44
Claim 44 is drawn to a kit comprising no additional components other than printed matter. Where a product merely serves as a support for printed matter, no functional relationship exists. These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product. Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864. See MPEP § 2111.05(I)(B). Thus the instantly claimed written instructions hold no patentable weight. Examiner recommends canceling this claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1, 4-5, 8-13, 17, 30-31, 33-34, 36-43, and 92-95 are allowable over the prior art in light of surprising results, discussed below.
Fig 25 (reproduced below) demonstrates synergism in a method of treating cancer, sufficient to overcome a conclusion of obviousness. Given the data for the individual components, one of skill in the art would have expected a percent survival of 53% by the study’s conclusion (26% from avelumab + 27% from ADC molecule 4) for the combination therapy, however a survival rate of 77-100% for the combination therapy was actually observed.
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Claim 1 is limited to the ADC Molecule 4 which has the following structure drug and linker structure shown below (instant pg 215). The antibody fragment is 1848-H01, corresponding to SEQ ID NO: 362 for the VH and SEQ ID NO: 367 for the VL (instant pg 215; Table 32).
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Applicant verified the antibodies described in claim 1 possess similarly high binding affinities for FOLR1 as antibody 1848-H01 of ADC Molecule 4 in their Response to Arguments mailed on 5/12/2025, thus the synergy between an anti-PD-L1 antibody the ADCs of the invention comprising both the antibody of claim 1 and conjugate P are expected to exhibit the same synergistic relationship. Absent the teachings of the instant application, one of skill in the art would not have predicted this synergy between this specific anti-FOLR1 antibody-drug conjugate and a PD-1/PD-L1 inhibitor.
Response to Arguments
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
112(b); pg 22, para 3
Applicant argues they’ve amended claim 34 so that it is compliant with the requirements of 112(b).
The amendments made partially satisfied the requirements, but still need to address the method step that is included as part of a product claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675