DETAILED ACTION
This office action is in response to applicant’s filing dated February 3, 2023.
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 .
Status of claims
Claims 1 - 16 are pending in the instant application. Claims 5, 8 – 10 and 12 – 16 are not examined for the reasons, recited below (see claim objection section).
Priority
This application is a 371 of PCT/EP2021/071856 filed August 5, 2021, which claims priority to European Patent Application No. EP 20189707.1, filed August 5, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/10/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
Acknowledgement is made of the drawings received on 02/03/2023. These drawings are accepted.
Claim Objections
Claims 5, 8 – 10 and 12 – 16 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claims cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, the claims 5, 8 – 10 and 12 – 16 not been further treated on the merits.
Claim Interpretation
Claims 1 – 4, 6 – 7 and 11 recitation: “A cyclodextrin-containing polymer-topoisomerase inhibitor conjugate for use in treating […]”, is not a structural limitation but mere statement of purpose or use. Regarding claim preamble, see MPEP 2111.02, Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation").
Regarding limitation “[…]wherein the use is[…]” (claims 1 – 3), such limitation of instant claims does not carry patentable weight because it is an intended use of the composition (i.e. an intent to use the cyclodextrin-containing polymer-topoisomerase inhibitor conjugate for treating cancer (e.g. ovarian gastric etc.) which does not impart any physical or material characteristics to the composition.
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.
Claim 4 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 claim recites the term:”[…] “preferably” , (line 3) which is equivalent to phrase “such as”, renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1 – 4, 6 – 7 and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Ryan et al (US 2011/0245201 A1, cited in IDS, filed 05/10/2023, hereinafter Ryan).
Instant claims are drawn to a cyclodextrin-containing polymer-topoisomerase inhibitor conjugate (e.g. CRLX-101):
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, where n is about 77 and m is about 14, wherein the cyclodextrin-containing polymer- topoisomerase inhibitor conjugate is nanoparticulate and which is in combination with PARP inhibitor (e.g. Olaparib) useful for treatment of advanced or metastatic ovarian cancer in a subject. The conjugate CRLX-101 is also useful for treatment of gastric, colorectal, cervical and pancreatic cancer.
Ryan teaches CDP-camptothecin conjugate CRLX101:
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, where n= about 77 and m= about 14 (page 37, [0423]). Ryan further teaches a method for treating advanced ovarian cancer, platinum-based agent resistant or relapsed ovarian cancer (page 4, [0045]) comprising administering CDP-camptothecin conjugate CRLX101. The CDP-camptothecin conjugate CRLX101, taught by Ryan, is administered in combination with additional therapeutic agent, such as PARP-inhibitor (e.g. Olaparib (page 18, [0183]). The composition of Ryan is also useful for treatment of gastric, colorectal, cervical (page 60, [0709]) and pancreatic cancer (page 4, [[0045]).
Thus, teachings of Ryan anticipate the composition of instant claims 1 – 4, 6 – 7 and 11.
Conclusion
Claims 1 – 4, 6 – 7 and 11 are rejected. Claims 5, 8 – 10 and 12 – 16 are objected to. No claim is allowed.
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/E.V.V./Examiner, Art Unit 1691
/SAVITHA M RAO/Primary Examiner, Art Unit 1691