DETAILED ACTION
Response to Amendment
The amendment filed March 30, 2026 has been entered. Claims 1 and 24 have been amended. Claims 1-25 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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.
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Claims 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of co-pending Application No. 17/948,277 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the claims of application ‘277 recite an implantable and refillable device comprising a reservoir, a release structure, a septum, and a backing layer. The claims are considered to overlap almost entirely with the only difference lying in the preamble wherein the instant application claims a “device for delivering a contraceptive agent”, as opposed to the more general “device for delivering a drug compound” of the ‘277 application. The contraceptive of the instant application is a drug compound per se and, while narrower in scope, is still considered to overlap with the co-pending application as the devices comprise the same claimed structure.
Regarding claims 2-19, the subject matter is known from claims 2-19 of the co-pending application of which the claims are duplicates.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 20-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of co-pending Application No. 17/948,271 in view of Pinchuk (US 2023/0181357), and further in view of Hyde et al. (US 2009/0259217).
Regarding claim 20, the co-pending application claim 1 discloses the implantable and refillable drug delivery device as set forth above, but fails to explicitly disclose the step of refilling and the use of a contraceptive agent.
Regarding claims 20 and 22, Pinchuk discloses teaches a method of refilling an implanted device (¶ [0071]) as per claim 20, but fails to explicitly disclose the device being used to deliver a contraceptive.
Hyde et al. (henceforth Hyde) teaches an implanted drug delivery device (e.g., ¶ [0090]) which is used to deliver a contraceptive (e.g., progestogen as per claim 22; ¶ [0086]).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the implantable drug delivery device of claim 1 to deliver a contraceptive since Hyde teaches that the delivery of such drugs is known for implantable device and therefore would be an obvious choice for one of ordinary skill to deliver for such an effect.
Regarding claim 21, the claimed method is known from Pinchuk wherein a refilling method comprises: inserting a needle through the septum, injecting an agent into a reservoir through the needle, and retracting the needle from the septum (see e.g., ¶ [0017] of Pinchuk which discloses a standard refilling procedure for a self-sealing septum of an implanted device).
Regarding claim 23, Hyde further teaches the use of an estrogen (¶ [0087]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide an estrogen to the reservoir for delivery if desired for the treatment as above for claim 20.
Claims 24-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of co-pending Application No. 17/948,271 in view of Pinchuk (US 2023/0181357) in view of Hyde et al. (US 2009/0259217), and further in view of Schneider (US 2019/0358166).
Regarding claim 24, Pinchuk/Hyde the refilling of an implantable device of co-pending application claim 1 via the claimed method of claim 20 but fail to explicitly disclose the release structure.
Schneider teaches an implantable device for delivering a contraceptive agent (it’s capable of delivering any desired drug therethrough), the device comprising: a reservoir (core 140 and membrane layer 122) within which the contraceptive agent is capable of being retained (¶ [0045]), wherein the reservoir defines a first surface (161) and a second surface (adjacent 123) opposing the first surface; a release structure comprising a hydrophobic polymer and surrounding at least a portion of the reservoir (¶¶ [0045]-[0046]; the release is from the reservoir through either of the polymeric membranes), wherein the release structure is in communication with the reservoir such that an agent can pass from the reservoir through the release structure (¶ [0045]). Schneider teaches an implantable drug reservoir which may be considered as 122. Therefore, any drug placed into core 140 will pass into the second membrane layer 122 and may be considered as “refilling” the reservoir formed as 122 as it diffuses therethrough. As understood from the disclosure, however, the reservoir is filled via a standard refilling procedure wherein the reservoir is refilled via a needle and passes out into the tissue via the release structure. There is no disclosure of the release structure receiving the drug which then passes into the reservoir to refill it without the needle present.
Regarding claim 25, Schneider further discloses the device as subcutaneously implanted (¶ [0028]).
This is a provisional nonstatutory double patenting rejection.
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.
Claim(s) 1-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US 2019/0358166) in view of Pinchuk et al. (US 2023/0181357), and further in view of Watson et al. (US 2002/0138068).
Regarding claim 1, Schneider discloses an implantable device for delivering a contraceptive agent (it’s capable of delivering any desired drug therethrough), the device comprising: a reservoir (core 140 and membrane layer 122) within which the contraceptive agent is capable of being retained (¶ [0045]), wherein the reservoir defines a first surface (161) and a second surface (adjacent 123) opposing the first surface; a release structure comprising a hydrophobic polymer and surrounding at least a portion of the reservoir (¶¶ [0045]-[0046]; the release is from the reservoir through either of the polymeric membranes), wherein the release structure is in communication with the reservoir such that the contraceptive agent can pass from the reservoir through the release structure (¶ [0045]). Schneider fails to explicitly disclose that the device is refillable, the septum, the backing layer, and the retaining ring.
Pinchuk et al. (henceforth Pinchuk) teaches an implantable drug delivery device which uses a needle (5) to fill or refill a reservoir with a therapeutic agent (¶ [0017]); wherein the implantable drug delivery device comprises a septum (3), and further comprising a backing layer (needle stop 9) adjacent a surface of the reservoir.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implantable drug delivery device of Schneider with the septum of Pinchuk so as to provide a means of refilling the device after implantation without losing any of the drug from the reservoir as taught by Pinchuk (¶¶ [0017] and [0019]).
As above, Schneider also fails to disclose the claimed backing layer. Pinchuk further teaches a backing layer (needle stop 9).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the implantable drug delivery device of Schneider with the backing layer of Pinchuk so as to provide a means of preventing injury to the underlying tissue via a needle stop element during a refill procedure as taught by Pinchuk (¶¶ [0017] and [0019]).
Furthermore, Schneider/Pinchuk fail to disclose the retaining ring to compress and secure the release structure against the septum.
Watson et al. (henceforth Watson) teaches (Figures 1-2) an implantable refillable drug delivery device comprising a septum (110) and a retaining ring (105) for securing the septum to the body of the device (120; ¶ [0018]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Schneider to include the retaining ring of Watson so as to provide a means of retaining the release structure against the septum as taught by Watson (¶ [0018]).
Regarding claim 2, Schneider further discloses that the device has a generally circular cross-section (Figure 3, ¶ [0045]).
Regarding claim 3, Schneider further discloses a volume from about 0.5 to about 5 mL (¶ [0061] sets forth the dimensions of the core as 1 mm x 23 mm which equates to a volume of 0.4153 mL which is “about 0.5 mL” as claimed. Furthermore, example 1 disclosed in ¶ [0056] sets forth a diameter of 25 mm which would equate to 0.49 mL in the reservoir. Finally, see also ¶ [0028] which discloses that the discs may have a diameter from about 0.5 mm to about 50 mm.
Regarding claim 4, Schneider further discloses wherein the device is in the form of a disc (Figure 3; ¶ [0045]).
Regarding claims 5-8, Schneider further discloses wherein the hydrophobic polymer comprises a semi-crystalline olefin copolymer (¶¶ [0033]-[0034] and [0061]; Ateva® 2861A is recognized as suitable ethylene vinyl acetate copolymer, see ¶ [0047], wherein ethylene is recognized as an olefin and vinyl acetate is a polar monomer (as per claim 6) which form a semi-crystalline olefin copolymer that is hydrophobic in nature).
Regarding claim 11, Schneider further discloses wherein the hydrophobic polymer has a melt flow index of from about 0.2 to about 100 grams per 10 minutes as determined in accordance with ASTM D1238-13 at a temperature of 190°C and a load of 2.16 kilograms (Schneider discloses the use of Elvax® 40W which is the same compound composition set forth in the instant application paragraph [0023] and as such it will have the same material properties as that claimed). See also (see NPL from IDS filed February 27, 2025 titled: “DuPont™ Elvax® EVA resins for Adhesives, Sealants and Wax Blends…” at Page 3, top of table which discloses the melt index within the claimed range).
Regarding claims 12 and 13, Schneider further discloses the use of a hydrophilic compound in the release structure (see e.g., ¶ [0061] which discloses the use of polyethylene glycol or “PEG” which is set forth as an example polymer in instant ¶ [0030]).
Regarding claim 14, Schneider further discloses the use of a plurality of water soluble particles distributed within the release structure (see ¶ [0050] which discloses the addition of polyoxyethylene to the reservoir structure which forms a water soluble hydrophilic surfactant).
Regarding claim 15, Schneider/Pinchuk further teach that the septum (3 of Pinchuk) comprises a material that exhibits a Shore A hardness of about 40 or less (¶ [0016] discloses a variety of Shore hardness ranges, which overlap those claimed, for the different layers of the device).
Regarding claim 16, Schneider/Pinchuk further teach that the septum comprises a nitrile rubber, styrene block copolymer, polyurethane, silicone elastomer, or a combination thereof (¶ [0018] of Pinchuk teaches rubber or other suitable polymers including polystyrene).
Regarding claim 17, Pinchuk further teaches wherein the septum comprises multiple layers (Figure 1A; layers 6, 7, 8; ¶¶ [0016]-[0017]).
Regarding claim 18, Pinchuk further teaches wherein the backing layer (9) teaches a puncture-resistant material comprising a metal (e.g., titanium or stainless steel as per ¶ [0019]).
Claim(s) 9 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Pinchuk, and further in view of Osato et al. (NPL: “Self-healing properties of poly(ethylene-co-vinyl acetate) as retrieved from IDS filed February 27, 2025)”.
Regarding claims 9 and 10, Schneider/Pinchuk teach the device as set forth above for claim 6, and further teaches the use of an ethylene vinyl acetate copolymer (as above for claim 6; see also ¶ [0035] of Schneider which discloses the use of ELVAX®40W). The disclosure fails to explicitly disclose the wt. % of polar monomer, however, the product data sheet for the disclosed ELVAX®40W discloses a 40 wt. % (see NPL from IDS filed February 27, 2025 titled: “DuPont™ Elvax® EVA resins for Adhesives, Sealants and Wax Blends…” at Page 5, bottom table). Schneider fails to explicitly disclose this polymer composition for a self-sealing membrane. Osato et al. (henceforth Osato) teaches that poly(ethylene-co-vinyl-acetate) with 42 wt. % of vinyl acetate exhibits automatic self-healing properties at room temperature (Page 542).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the polymer composition of the reservoir of Schneider/Pinchuk to comprise the wt. % of ethylene vinyl acetate copolymer so as to provide for a known self-healing polymeric membrane which closes after needle removal as such a membrane polymer is known from Osato. Osato further teaches that such a vinyl acetate content exhibits self-healing at room temperature and above which would include uses within the body (Osato at Page 542). Therefore, it would have been obvious to modify the self-healing polymer membrane material of the Schneider/Pinchuk device as one of ordinary skill would have a reasonable expectation of success in changing the self-healing SIBS membrane of Pinchuk for the combined device via application of known polymer concentrations as known from Osato since Osato teaches that the polymer weight can be used to form membranes for the same function while retaining the self-sealing properties during use at a body temperature.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Pinchuk, and further in view of Raven (US 2011/0196195).
Regarding claim 19, Schneider/Pinchuk teach the claimed invention substantially as set forth above for claim 18 and Pinchuk further teaches wherein the backing layer (9) comprises polyimide (¶ [0019] of Pinchuk discloses the use of polyimide for the backing layer). Schneider/Pinchuk fail to explicitly teach the polyimide in the form of a fiber.
Raven et al. (henceforth Raven) teaches an implantable access site comprising a needle resistant layer material (54) formed as a woven or reinforce fabric of various materials including polyimide (¶ [0052]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the backing layer of Schneider/Pinchuk to form the polyimide plate from a woven material as Raven teaches that such a conformation is known in use as a needle resistant material in implantable medical devices. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in forming the backing layer of Schneider/Pinchuk in such a manner to result in a biocompatible needle-impenetrable layer to protect underlying tissue during needle insertion as taught by Raven.
Claim(s) 20-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schneider in view of Pinchuk in view of Watson, and further in view of Hyde et al. (US 2009/0259217).
Regarding claims 20 and 22, Schneider/Pinchuk/Watson teach the claimed invention substantially as set forth above for claim 1, but fail to explicitly disclose the device being used to deliver a contraceptive.
Hyde et al. (henceforth Hyde) teaches an implanted drug delivery device (e.g., ¶ [0090]) which is used to deliver a contraceptive (e.g., progestogen as per claim 22; ¶ [0086]).
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize the implantable drug delivery device of claim 1 to deliver a contraceptive since Hyde teaches that the delivery of such drugs is known for implantable device and therefore would be an obvious choice for one of ordinary skill to deliver for such an effect.
Regarding claim 21, the claimed method is known from Pinchuk wherein a refilling method comprises: inserting a needle through the septum, injecting an agent into a reservoir through the needle, and retracting the needle from the septum (see e.g., ¶ [0017] of Pinchuk which discloses a standard refilling procedure for a self-sealing septum of an implanted device).
Regarding claim 23, Hyde further teaches the use of an estrogen (¶ [0087]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide an estrogen to the reservoir for delivery if desired for the treatment as above for claim 20.
Regarding claim 24, Schneider fails to explicitly teach the step of refilling the membrane.
Pinchuk further teaches a refilling step (¶¶ [0017] and [0040] disclose refilling the reservoir via a needle). In addition, Watson teaches the step of refilling the reservoir (¶ [0018]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of use of the device of Schneider to include a step of refilling the core or reservoir of Schneider so as to allow for multiple uses of the device during a treatment as taught by both Pinchuk and Watson. In this manner, the outer layers of the device of Schneider can continue to control the release rate of the drug from the core through a number of cycles while the device is implanted.
Regarding claim 25, Schneider further discloses the device as implanted (¶¶ [0028]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN L ZAMORY whose telephone number is (571)270-1238. The examiner can normally be reached M-F 8:30am-4:30pm ET.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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