DETAILED ACTION
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/17/2025 has been entered.
Previous Rejections
Applicant’s arguments, filed 12/17/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1, 4-5, 10, 12-13, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al (WO 2018/206749 A1), in view of Haffner et al (US 2014/0303544 A1).
Thakur taught an ocular implant comprising 1 to 5, and 10 % of a therapeutic agent; 60 to 99 % (w/w) of a photopolymerizable crosslinked composition of polyalkylene glycol diacrylate monomers (e.g., reads on crosslinked polymer matrix); and 1-40 % PLGA (e.g., reads on biodegradable polymer) [abstract; claims 1-2 and 13; page 1, section b; page 6, line 16; Figure 9]. The implants were coated with a single layer of 4-15 % PCL [page 13, 4th paragraph; page 14, line 6] or PLC [page 1, section b] having a thickness of 0.2 to 1 mm (200 to 1000 µm; see claim 6), and further comprised polyethylene glycol, to increase both porosity and release of the therapeutic agent (e.g., dexamethasone, see Table 1) (e.g., reads on release modulating agent; reads on a porous coating layer) [page 30, 1st paragraph]. In one embodiment, the drug release was sustained for a period of greater than about 6 months [page 17, Process, 3rd and 4th paragraphs].
Although Thakur taught drug release, sustained for a period of greater than about 6 months, Thakur was not specific that the release was zero order, as recited in claim 1. Thakur did not teach the diameter and length of the implant, as recited in claim 1. Additionally, Thakur taught up to 10 % active agent, rather than 20-50 % therapeutic agent.
Haffner taught ocular implants providing release of an active agent at a therapeutically effective amount, for a period of time between several days, one to two months, at least six months, at least a year, at least two years, at least three years, at least four years, and/or at least five years [abstract; ¶ 0078]. The implant system of the disclosure showed that the release of the active agent (e.g., dexamethasone) was zero order [0225, 0420]. The amount of the active agent was about 70 % [0237]. The implants had diameters of about 150 microns (0.15 mm) to about 500 microns (0.5 mm) [0053], and a length of 2 mm [0075], in order to accommodate the parameters of the eye [0081].
Since Thakur taught drug release to the eye, wherein the release was sustained for more than 6 months, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Thakur, zero-order release rates (e.g., zero-order release for at least six months, at least a year, at least two years, at least three years, at least four years, and/or at least five years), as taught by Haffner. The ordinarily skilled artisan would have been motivated to maintain therapeutic drug levels, as taught by Haffner [abstract; ¶ 0078].
The instant claims 1 and 17 recite 20 to 50 % of a therapeutic agent; 40 to 60 % of a crosslinked matrix; 0.1-10 % PLGA; 10 to 20 % PCL with 20 to 25 µm thickness; implant diameter of 0.1 to 0.5 mm and length of 0.5 to 2 mm; zero-order release over 180 days.
Thakur taught 1 to 5, and 10 % of a therapeutic agent; 60 to 99 % (w/w) of a photopolymerizable crosslinked composition of polyalkylene glycol diacrylate monomers (e.g., reads on crosslinked polymer matrix); 1-40 % PLGA and drug release of over 6 months. Haffner taught 70 % therapeutic agent; implant diameters of about 150 microns (0.15 mm) to about 500 microns (0.5 mm), and a length of 2 mm; zero-order release (the period of time was at least six months, at least a year, at least two years, at least three years, at least four years, and/or at least five years). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding the amount of the thickness (of PCL), claim 1 requires about 20 µm to about 25 µm. Thakur taught a thickness of 0.2 to 1 mm (200 µm to 1000 µm). The ordinarily skilled artisan would have been motivated to have modified this to have been 20 µm to 25 µm. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of administration of ocular implants to treat ocular disorders [see Thakur at the whole of page 1] have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum thickness of PCL via routine experimentation.
Regarding the amount of the therapeutic agent, the instant claims 1 and 17 require 20 to 50 %. Haffner taught 70 %. The ordinarily skilled artisan would have been motivated to have modified this to have been 20 to 50 %. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of administration of ocular implants to treat ocular disorders [see Haffner at the abstract] have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum amount of the therapeutic agent via routine experimentation.
Further regarding claims 1 and 17, the instant claims recite “a crosslinked polymer matrix obtained by crosslinking a photopolymerizable composition”. The limitation of obtaining a crosslinked polymer matrix by crosslinking a photopolymerizable composition is a product-by-process limitation. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Even though product-by-process claims are limited by and defined by the process, the determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product, in the product-by-process claim is the same as, or obvious from a product of the prior art, then the claim is unpatentable, even though the prior art product was made by a different process. In the instant case, the ocular implant of the combined teachings of Thakur and Haffner reads on the claimed ocular implant. As such, the patentability of the instant composition does not depend on its method of production, and the Applicant’s limitation regarding obtaining a crosslinked polymer matrix by crosslinking a photopolymerizable composition is not patentable, in view of the combined teachings of Thakur and Haffner. MPEP 2113.
Thakur et al, in view of Haffner, reads on claims 1, 4-5, 10, 12-13, 16 and 17.
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered, but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Nonstatutory Double Patenting
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, 4-5, 10, 12-13, 16 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/000,937, in view of Thakur et al (WO 2018/206749 A1), in view of Haffner et al (US 2014/0303544 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are further limited by the amount and thickness of the PCL, the diameter and length of the implant, and by a zero-order release over 180 days, limitations of which are not recited by the copending claims.
Thakur taught an ocular implant coated with a single layer of PCL, having a thickness of 0.2 to 1 mm (200 to 1000 µm). In one embodiment, the drug release was sustained for a period of greater than about 6 months.
Haffner taught ocular implants providing release of an active agent at a therapeutically effective amount, for a period of time between several days, one to two months, at least six months, at least a year, at least two years, at least three years, at least four years, and/or at least five years. The implant system of the disclosure showed that the release of the active agent was zero order. The implants had diameters of about 150 microns (0.15 mm) to about 500 microns (0.5 mm), and a length of 2 mm, in order to accommodate the parameters of the eye.
Regarding the amount of the thickness (of PCL), the instant claim requires about 20 µm to about 25 µm. Thakur taught a thickness of 0.2 to 1 mm (200 µm to 1000 µm). The ordinarily skilled artisan would have been motivated to have modified this to have been 20 µm to 25 µm. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of administration of ocular implants to ocular disorders [see Thakur at the whole of page 1] have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum thickness of PCL via routine experimentation.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the copending claims, zero-order release rates, as taught by Haffner. The ordinarily skilled artisan would have been motivated to maintain therapeutic drug levels, as taught by Haffner.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the copending claims, implants with diameters of about 150 microns (0.15 mm) to about 500 microns (0.5 mm), and a length of 2 mm, as taught by Haffner. The ordinarily skilled artisan would have been motivated to accommodate the parameters of the eye, as taught by Haffner.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4-5, 10, 12-13, 16 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 11,504,340, in view of Thakur et al (WO 2018/206749 A1), in view of Haffner et al (US 2014/0303544 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are further limited by the amount and thickness of the PCL, the diameter and length of the implant, and by a zero-order release over 180 days, limitations of which are not recited by the issued claims.
Thakur taught an ocular implant coated with a single layer of PCL, having a thickness of 0.2 to 1 mm (200 to 1000 µm). In one embodiment, the drug release was sustained for a period of greater than about 6 months.
Haffner taught ocular implants providing release of an active agent at a therapeutically effective amount, for a period of time between several days, one to two months, at least six months, at least a year, at least two years, at least three years, at least four years, and/or at least five years. The implant system of the disclosure showed that the release of the active agent was zero order. The implants had diameters of about 150 microns (0.15 mm) to about 500 microns (0.5 mm), and a length of 2 mm, in order to accommodate the parameters of the eye.
Regarding the amount of the thickness (of PCL), the instant claim requires about 20 µm to about 25 µm. Thakur taught a thickness of 0.2 to 1 mm (200 µm to 1000 µm). The ordinarily skilled artisan would have been motivated to have modified this to have been 20 µm to 25 µm. Where 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. See MPEP 2144.05(II)(A). In this case, the general conditions of administration of ocular implants to ocular disorders [see Thakur at the whole of page 1] have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum thickness of PCL via routine experimentation.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, zero-order release rates, as taught by Haffner. The ordinarily skilled artisan would have been motivated to maintain therapeutic drug levels, as taught by Haffner.
It would have been prima facie obvious to one of ordinary skill in the art to include, within the issued claims, implants with diameters of about 150 microns (0.15 mm) to about 500 microns (0.5 mm), and a length of 2 mm, as taught by Haffner. The ordinarily skilled artisan would have been motivated to accommodate the parameters of the eye, as taught by Haffner.
Response to Arguments
Applicant’s arguments with respect to the instant claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612