DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I and the species where the bioabsorbable polymer is poly(lactide-co-glycolide) and the therapeutic agent is a cytotoxic agent in the reply filed on February 3, 2026 is acknowledged. The applicant specifies the polymer to be a random arrangement of monomers; however, such a level of specificity was not required for the election and the monomer arrangement in the poly(lactide-co-glycolide) polymers was not specified in the disclosure.
An additional species was encountered during the course of searching where the bioabsorbable polymer is a combination of poly(lactide-co-glycolide) and poly(ethylene glycol); therefore this additional species has been rejoined.
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Objections
Claim 4 is objected to because of the following informalities: Claim 4 contains an unnecessary recitation of the word “is” in line 2.
Appropriate correction is required.
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.
Claims 5-6 and 9 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 5 recites that “the one or more therapeutic agents have a dose…”. The recitation does not state that the solid implant has a particular dose of the one or more therapeutic agents, but that the therapeutic agents have a particular dose. Thus it is unclear if the one or more therapeutic agents need to be effective at a dose within recited range or are present in an amount that is within the recited dose range.
Claim 9 recites the trademark/trade name Pluronic® as a limitation. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name Pluronic® is used to identify/describe varieties of block copolymers of polyethylene oxide and polypropylene oxide that are also termed poloxamers. Accordingly, the identifications/descriptions are indefinite.
Claim 9 recites the listing “silk-elastin like protein polymer, Pluronics F68, Pluronics F127, or a combination thereof, poly(e-caprolactone) (PCL), a polylactide (PLA), poly(D,L-lactide) (PDLA)…, and any combinations of block or random co-polymers thereof.” The scope of polymers embraced by this recitation is unclear for the embodiments of “a combination thereof” as part of a “block or random co-polymer thereof.”
Claims that are rejected but are not elaborated upon are also indefinite because they depend from an indefinite claim and do not add clarity.
Claim Rejections - 35 USC § 102
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al. (Drug Delivery 2019 26(1):1049–1057).
Gao et al. disclose a rod composed of poly(lactide-co-glycolide) (PLGA), doxorubicin, and poly(ethylene glycol) (see page 1050 first column last full paragraph; instant claims 1, 7-10). The rods have 25 wt% doxorubicin, a length of 4 ± 0.23 mm, a diameter of 0.86 ± 0.01 mm, and a weight of 2.88 ± 0.29 mg (see page 1053 first column last paragraph; instant claims 3-4). When rounded, the dimensions of the rod correspond to 4 mm x 1 mm (see instant claim 2). The doxorubicin is present in the implant at about 0.6375 mg, based on the 25 wt% loading (as calculated by the examiner; see instant claim 5). A group of 10 such implants are assessed, thereby meeting the limitation of a plurality of implants with about 6.375 mg doxorubicin (see instant claim 6). The proportion of doxorubicin corresponds to a weight ratio of 1:3 doxorubicin to polymer (see instant claim 4). Therefore claims 1-10 are anticipated by Gao et al.
Claims 1-2, 4, 7, and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McConville et al. (International Journal of Pharmaceutics 2015 494:73-82) as evidenced by Wiggins et al. (Biochemical Pharmacology 2015 93:332-342).
McCoville et al. disclose a rod composed of poly(D,L-lactide-co-glycolide) at a 50:50 monomer ratio with disulfiram (see page 74 second column first full paragraph; instant claims 1 and 10-11). The rods have 10 to 20 wt% disulfiram, a length of 3 mm, and a diameter of 1 mm (see page 74 second column second full paragraph page 1053 first column last paragraph; instant claims 2 and 4). The proportion of disulfiram corresponds to a weight ratio of 1:9 or 1:4 disulfiram to polymer (see instant claim 4). McCoville et al. detail that the disulfiram is cytotoxic (see page 80 second column first full paragraph). Wiggins et al. also discuss the cytotoxicity of disulfiram at various concentrations against breast cancer cells (see page 334 second column last partial paragraph-page 335 first column first partial paragraph and figure 2) Therefore claims 1-2, 4, 7, and 10-11 are anticipated by McCoville et al. as evidence by Wiggins et al.
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, 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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. in view of Choi et al. (Colloids and Surfaces B: Biointerfaces 2015 132:305–310)
Gao et al. disclose a rod composed of poly(lactide-co-glycolide) (PLGA) , doxorubicin, and poly(ethylene glycol) (see page 1050 first column last full paragraph; instant claims 1, 7-10). The rods have 25 wt% doxorubicin a length of 4 ± 0.23 mm, a diameter of 0.86 ± 0.01 mm and a weight of 2.88 ± 0.29 mg (see page 1053 first column last paragraph; instant claims 3-4). When rounded, the dimensions of the rod correspond to 4 mm x 1 mm (see instant claim 2). The doxorubicin is present in the implant at about 0.6375 mg based on the 25 wt% loading (as calculated by the examiner; see instant claim 5). A group of 10 such implants are assessed, thereby meeting the limitation of a plurality of implants with a about 6.375 mg doxorubicin (see instant claim 6). The proportion of doxorubicin corresponds to a weight ratio of 1:3 doxorubicin to polymer (see instant claim 4). The PLGA has an inherent viscosity of 0.21 dL/g and a 75:25 ratio of lactide to glycolide (see page 1050 first full paragraph; instant claims 11-12). The enantiomer(s) of the lactide employed in the PLGA is not detailed.
Choi et al. teach of the utility of D,L-PLGA with a 75:25 lactide to glycolide ratio to successfully deliver doxorubicin (see abstract and page 306 first column first-third paragraphs and figure 3-4; instant claim 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose D,L-PLGA as the PLGA of Gao et al. because it was already known to deliver the same drug, in light of het teachings of Choi et al. Therefore claims 1-12 are obvious over Gao et al. in view of Choi et al.
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.
The following are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 4, 7-8, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 18/545564 (reference application) in view of Zeng et al. (US PGPub No. 2016/0220490) and Dizerega et al. (US PGPub No. 2020/0170992).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims recite a rod implant that has the same range of sizes for a first and second dimension and that is composed of a bioabsorbable polymer and one or more therapeutic agents. The copending claims recite the rod as a locally administered treatment for benign prostatic hyperplasia but do not recite a particular therapeutic or bioabsorbable polymer.
Dizerega et al. teach paclitaxel as a locally delivered therapeutic agent to treat benign prostatic hyperplasia (see abstract and paragraph 13).
Zeng et al. teach a solid implant compositions composed of PLGA and paclitaxel (see abstract and paragraph 7). The PLGA has a 50:50 ratio of monomers and a paclitaxel loading of 10 wt% in the polymer which yields a 1:9 ratio of drug to polymer (about 1:10) (see paragraph 8). The polymer is envisioned with a molecular weight of 16,000 Da (see paragraph 8).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose paclitaxel as the therapeutic agent and the PLGA of Zeng et al. as the polymer of the copending claims. These choices would have been obvious because they were known together in a solid implant and paclitaxel was known to treat the condition of interest in the copending claims, in light of Dizerega et al. Therefore claims 1-2, 4, 7-8, and 10 are obvious over claims 1 and 4 of copending Application No. 18/545564 in view of Zeng et al. and Dizerega et al.
Claims 1-2, 4, 7-8, and 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 18/545564 in view of Zeng et al. and Dizerega et al. as applied to claims 1-2, 4, 7-8, and 10 above, and further in view of Avgoustakis ("Polylactic-co-glycolic acid (PLGA)." Encyclopedia of biomaterials and biomedical engineering 1.1 (2005): 1-11).
Claims 1 and 4 of copending Application No. 18/545564 in view of Zeng et al. and Dizerega et al. render obvious the limitations of instant claims 1-2, 4, 7-8, and 10, where the limitations of claims 11 and 12 are also taught with the exception of the lactide enantiomer. The enantiomer of lactide in the PLGA is not detailed.
Avgoustakis teach that lactide exists in 4 enantiomeric forms, L, D, meso, and racemic which is also known as LD (see page 1 second column last partial paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose any of the four forms of lactide taught by Avgoustakis for the PLGA polymer of the modified copending claims because there is a small finite number that is possible. Therefore claims 1-2, 4, 7-8, and 10-12 are obvious over claims 1 and 4 of copending Application No. 18/545564 in view of Zeng et al., Dizerega et al., and Avgoustakis.
Claims 1-8 and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of copending Application No. 18/545564 in view of Zeng et al. and Dizerega et al. as applied to claims 1-2, 4, 7-8, and 10 above, and further in view of Adorini et al. (US PGPub No. 2005/0065124).
Claims 1 and 4 of copending Application No. 18/545564 in view of Zeng et al. and Dizerega et al. render obvious the limitations of instant claims 1-2, 4, 7-8, and 10. Dizerega et al. teach that the paclitaxel is provided in an amount that is 10% of the prostate volume and a concentration ranging from 6 to 15 mg/ml (see paragraph 122) Zeng teach a plurality of the solid forms being administered (see paragraph 13). The mass of the copending implant and paclitaxel is not detailed.
Adorini et al. teach that prostates relevant for treatment of the condition of interest to the copending claims could have a volume of 40 ml or less (see paragraph 149).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce the implants of the modified copending claims in order to facilitate dosing as desired to treat the condition of interest. Given the teachings of Dizerega et al. with Adorini et al., 10% of a 40 ml or less prostate corresponds to administering 4 ml or less which for a 6 to 15 mg/ml paclitaxel composition translates to 24 to 60 mg of paclitaxel. Provision of such dosing via the implants of the modified copending claims would then be obvious as would the consideration of multi implants to reach this level in light of Zeng et al. The corresponding paclitaxel and implant weight then yield ranges that embrace or overlap with those instantly claimed, thereby rendering the claimed ranges obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). Therefore claims 1-8 and 10 are obvious over claims 1 and 4 of copending Application No. 18/545564 in view of Zeng et al., Dizerega et al., and Adorini et al.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615