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 .
Receipt is acknowledged of IDS filed on 11/04/2022.
Claims 1-24 are pending.
Claims 6-12, 17, and 22-23 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of species A, B, and C in the reply filed on 10/14/2025 is acknowledged.
Claims 6-12, 17, and 22-23 are withdrawn for being drawn towards unelected species.
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 1-5, 13-16, 18-21, and 24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of U.S. Patent No. 8986609. Although the claims at issue are not identical, they are not patentably distinct from each other because:
RAU teaches a method for sterilizing a water-insoluble composition using gamma radiation (claim 1). The method comprises providing the hydrogel and exposing the composition to gamma radiation (claim 1), which is a type of ionizing radiation. The composition comprises a polyethylene glycol (PEG) hydrogel complex (claim 1), which reads on polymer, that is loaded/embedded with small molecule biologically active moieties, that can be drug moieties (claim 5).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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.
Claims 1, 3, 4, 13-16, 19, 18, 19-21, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RAU (US 9,278,139).
Regarding claims 1 and 24, RAU teaches a method for sterilizing a water-insoluble composition using gamma radiation (abstract, claim 1, and column 4, paragraph 5). The method comprises providing the composition and exposing the composition to gamma radiation (claim 1), which is a type of ionizing radiation. The composition comprises a polyethylene glycol (PEG) hydrogel complex, which reads on polymer, that is loaded/embedded with small molecule biologically active moieties (column 17, paragraph 3). That can be drug moieties (claim 5).
Regarding claim 3, the composition comprises a polyethylene glycol hydrogel complex (column 17, paragraph 3).
Regarding claim 4 and 13, the ionizing radiation is gamma radiation (claim 1).
Regarding claim 14, the composition is irradiated (claim 1). Applicant’s specification states “As used herein the term "continuous irradiation" refers to a mode of irradiation in which the total radiation dose is administered without interruption of the ionizing irradiation.” (Applicant’s specification, parge 3, paragraph 2). Therefor being irradiated once would be considered continuous irradiation since no time limit is required to be considered “continuous”.
Regarding claim 15 and 16, the conjugate is irradiated with a dose of 32 kGy (column 17, paragraph 2).
Regarding claim 18, the formulation can be irradiated in a dry state (column 24, paragraph 8).
Regarding claim 19, the radiation is performed at 25 °C (column 16, paragraph 2).
Regarding claim 20 and 21, the composition comprises a hydrogel that is conjugated to small molecule biologically active moieties (claim 5). Multiple drugs can be linked through spacer moieties (column 8, paragraph 3).
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.
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 1-4, 13-16, 19, 18, 19-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over RAU (US 9,278,139) in view of VETTER (US 2015/0290337).
RAU teaches Applicant’s invention as discussed above.
RAU does not teach using a water-insoluble conjugate.
Regarding claim 2, VETTER teaches a PEG based water-insoluble hydrogel conjugate (page 9, paragraph 0156) that has biologically active moieties covalently conjugated through a reversible prodrug linker moiety that comprises a chemical bond or a spacer (page 42, paragraph 0541-0559). The hydrogel is sterilized using gamma radiation (page 9, paragraph 0153). The biologically active moieties can be drugs (page 61, paragraph 0781).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a PEG based water-insoluble hydrogel conjugate. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because a PEG based water-insoluble hydrogel conjugate and a PEG based water-insoluble hydrogel complex are functional equivalents of hydrogels used for drug delivery that can be sterilized using gamma radiation.
Claims 1-5, 13-16, 19, 18, 19-21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over RAU (US 9,278,139) and VETTER (US 2015/0290337) in view of DAI (Sterilization techniques for biodegradable scaffolds in tissue engineering applications. Journal of Tissue Engineering. 2016.).
RAU and VETTER teach Applicant’s invention as discussed above.
RAU and VETTER do not teach using electron beam for the ionizing radiation.
Regarding claim 5, DAI teaches that both gamma and electron beam irradiation are used to sterilize biodegradable polymers (page 3, paragraph 3). Electron beam radiation has the same sterilization effect as gamma radiation, but is known to cause less degradation to materials and can be done in a shorter time (page 3, paragraph 5).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using electron beam for the ionizing radiation. The person of ordinary skill in the art would have been motivated to make those modifications, because electron beam radiation causes less degradation to materials and can be done in a shorter time and reasonably would have expected success because gamma and electron beam irradiation are functional equivalents or irradiation techniques used to sterilize polymers for medical purposes.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL HARTLEY can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.L.M./ Examiner, Art Unit 1618
/Michael G. Hartley/ Supervisory Patent Examiner, Art Unit 1618