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
Claims 27, 28 and 30-32 are under consideration.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 27, 28 and 30-32, drawn to a micelle comprising A83B4C63 and SN-38 in the reply filed on March 30, 2026 is acknowledged.
Claims 1, 2, 5-7, 9-13, 15-19, 33 and 34 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 27, 28 and 30-32 as filed on April 10, 2025 are under consideration.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
The abstract of the disclosure is objected to because it is too short, it is an incomplete sentence that does not end with a period, and it is not sufficiently descriptive of the disclosure. Correction is required. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: paragraph [00136] refers to Supplementary Fig. 1, however, no corresponding figure appears to be of record. Appropriate correction is required.
Claim Objections
Claim 28 is objected to because of the following informalities:
Claim 28 should presumably recite “wherein the micelle comprises a block copolymer comprising” or some variation thereof because all of the enumerated alternatives encompass copolymers and because it is clear from paragraph [0088] that all of the copolymers are block copolymers.
Claim 28: the acronyms should be spelled out at the first recitation thereof, e.g., mPEO-b-PBCL should presumably recite “methoxy poly(ethylene oxide)-poly(a-benzyl carboxylate-e-caprolactone) (mPEO-b-PBCL)” as disclosed in paragraph [0097].
Appropriate correction is required.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of 35 U.S.C. 112 (pre-AIA ). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/244,315, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph for one or more claims of this application.
The prior-filed application does not disclose all of the copolymers of claim 28, does not disclose the degree polymerization of claim 31, and does not disclose the concentrations of claim 32.
The earliest date available to these claims is September 15, 2022.
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 31 and 32 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 pre-AIA the applicant regards as the invention.
Claim 31 recites the PBCL block of the block copolymer, however, claim 28 recites two copolymers comprising PBCL. It is unclear which of the two copolymers of claim 28 “the block copolymer” of claim 31 is intended to reference.
Claim 32 recites 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 32 recites the broad recitation 1 to 100 microns, and the claim also recites “preferably” 5 to 40 microns which is the narrower statement of the range/limitation and claim 32 also recites the broad recitation 0.001 to 10 microns, and the claim also recites “preferably” 0.005 to 1 microns which is the narrower statement 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 Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27, 28, 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US 2020/0148675, published May 14, 2020) in view of Carie et al. “IT-141, a polymer micelle encapsulating SN-38, induces tumor regression in multiple colorectal cancer models,” Journal of Drug Delivery 2011:869027, of record.
Hall teaches imidopiperidine compounds as inhibitors of polynucleotide kinase phosphate (title; abstract; claims). The compounds include one designated A83B4C63 (claim 49; page 59, first compound listed in Table E; page 71, first compound listed in Table 1).
Hall further teaches compositions comprising compounds inclusive of the one designated A83B4C63 and comprising micelles comprising PEO-b-PBCL, PEO-PCL, PEO-PDLA or/and PEO-PLGA (claims 49, 51-53), as required by instant claim 28. A83B4C63 has low water solubility and is solubilized within polymeric micelles (Example 2, paragraphs [0464]-[0467] and Table 1). Encapsulated A83B4C63 was employed at 6 microMolar (paragraph [0475]), as required by instant claim 32.
Hall further teaches the compositions may further comprise a topoisomerase I inhibitor such as irinotecan (claims 57, 58; paragraph [0256]). Hall further teaches methods of treating colorectal cancer (claims 67-72).
Hall does not specifically teach SN-38 as required by claim 27.
Hall does not teach SN-38 conjugated to a block copolymer as required by claim 30.
Hall does not teach 0.001 to 10 microMolar SN-38 as required by claim 32.
These deficiencies are made up for in the teachings of Carie.
Carie teaches SN-38, the active metabolite of irinotecan, is about 500 to 1000 more times cytotoxic than irinotecan (paragraph bridging pages 1 and 2). Carie further teaches a polymer micelle comprising SN-38 for treating colorectal cancer which was superior to irinotecan in terms of antitumor activity; the IC50 values range from about 0.0374 to 0.165 microMolar (title; abstract; Figure 1; Table 1), as required by instant claim 32. Carie further teaches a polymeric micellar formulation wherein SN-38 is covalently attached to a block copolymer in order to improve SN-38 solubility (page 2, lhc, 1st full paragraph), as required by instant claim 30.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute SN-38 as taught by Carie for the topoisomerase I inhibitor in the micellar compositions of Hall because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary.
Regarding claim 30, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the micellar compositions of Hall in view of Carie to comprise SN-38 covalently attached (conjugated) to a block copolymer as taught by Carie in order to improve SN-38 solubility.
Regarding claim 32, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the micellar compositions of Hall in view of Carie suitable for treating colorectal cancer to comprise 0.374 to 0.165 microMolar SN-38 as taught by Carie and to optimize therein in order to treat colorectal cancer. It is prima facie obvious to optimize such result-effective variables within prior art conditions or through routine experimentation. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US 2020/0148675, published May 14, 2020) in view of Carie et al. “IT-141, a polymer micelle encapsulating SN-38, induces tumor regression in multiple colorectal cancer models,” Journal of Drug Delivery 2011:869027, of record as applied to claims 27, 28, 30 and 32 above, and further in view of Lavasanifar et al. (US 2010/0069295, published March 18, 2010).
The teachings of Hall and Carie have been described supra.
While Hall teaches synthesis of block copolymers of PEO-b-PBCL with different degrees of polymerization for the PBCL segment (paragraph [0484]), Hall does not specifically teach the PBCL segment has a degree of polymerization between 1 and 50 as required by claim 31.
This deficiency is made up for in the teachings of Lavasanifar.
Lavasanifar teaches novel micelle forming poly(ethylene oxide)-block-poly(ester) block copolymers (title; abstract; claims). Lavasanifar exemplifies the synthesis of PEO-b-PBCL block copolymers inclusive of one comprising a block of 19 PBCL monomers (Example 2; Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the PEO-b-PBCL of the micellar compositions of Hall in view of Carie to comprise 19 PBCL monomers as taught by Lavasanifar because the block copolymers of Lavasanifar are micelle forming. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Chen et al. (CN 110179820 A, as evidenced by the Google translation) teaches pharmaceutical compositions comprising 0.125 to 4 microMolar SN38 (title; abstract; claims).
Kitagawa et al. (US 7,495,099) teaches water-soluble derivatives of camptothecins inclusive of 7-ethyl-10-hydroxycamptothecin (SN38) comprising block copolymers (title; abstract; claims; column 4, lines 46-55).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/
Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600
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