DETAILED ACTION
Notice of Pre-AIA or AIA Status
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 present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/03/2026 has been entered.
Claim Status
Applicant’s amendment of 03/03/2026 is acknowledged. Claim 1 is amended. Claims 1-39 are currently pending.
Priority
The instant application claims domestic benefit to U.S. Application No. 63/246,844 filed on 09/22/2021 and U.S. Application No. 63/305,772 file on 02/2/2022 as reflected in the filing receipt dated on 10/12/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 01/16/2026, 03/18/2026, and 05/08/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the Examiner.
Election/Restrictions
An election of invention/species was required in the instant application as detailed in the Office action dated 02/29/2024. The election is maintained and claims 21-23 and 25-39 remain withdrawn. Accordingly, claims 1-20 and 24 are examined on the merits herein.
For clarity of the record, the Examiner notes that a record of Applicant’s elected species can be found in the Examiner Interview Summary dated 05/22/2024, and it appears previous Examiner Janice Silverman extended the species election to include bisphosphonates as the drug compound (see Office action dated 05/22/2024).
In searching for Applicant’s elected species, art was found that reads on an additional species of the septum material recited in claim 15 and the backing layer material recited in claims 18 and 19. The species election was extended to include septum materials and backing layer materials taught in Pinchuk et al. (WO2021163159A1; published: 08/19/2021; PTO-892 of 02/20/2025), and subsequently the art was applied in the rejections of record to expedite prosecution.
Withdrawn Objections and Rejections
The following grounds of rejection are new or revised in view of Applicant’s amendment to the claims. Applicant’s arguments insofar as they pertain to any revised grounds of rejection are addressed herein.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US-PGPUB 20190358166A1; published: 11/28/2019; IDS of 12/29/2023) in view of Pinchuk et al. (WO2021163159A1; published: 08/19/2021; PTO-892 of 02/20/2025) and Forouzandeh et al. (Micromachines, vol. 11, pg. 1-17; published: 06/30/2020; PTO-892 of instant action).
Schneider discloses an implantable device for delivery of a drug compound, the device comprising: a core comprising a core polymer matrix containing a hydrophobic polymer within which is dispersed a drug compound, the polymer matrix containing a hydrophobic polymer; and a membrane layer positioned adjacent to the outer surface of the core, wherein the membrane layer comprises a membrane polymer matrix containing a hydrophobic polymer in combination with a hydrophilic compound [abstract; claims 1-35].
In some embodiments [fig. 3-4, shown below; 0061; 0065; 0067], the implantable device 100 contains a core 140 having a generally circular cross-sectional shape that is disc-shaped in nature [0045]. The core 140 defines an upper outer surface 161 on which is positioned a first membrane layer 120 and a lower outer surface 163 on which is positioned a second membrane layer 122 [0045]. Similar to the core 140, the first membrane layer 120 and the second membrane layer 122 also have a generally circular cross-sectional shape that generally covers the core 140 [0045]. During use of the device 100, a drug compound is capable of being released from the core 140 and through the first membrane layer 120 and second membrane layer 122 so that it exits from external surfaces 121 and 123 of the device [0045].
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Regarding claim 1: The core of the implantable device disclosed by Schneider, within which is dispersed a drug, reads on the claimed reservoir, wherein the upper and lower outer surfaces correspond to the claimed first and second surfaces, respectively. The membrane layers, which contain a hydrophobic polymer and cover the core, read on the claimed release structure. Because the compound is capable of being released from the core and through the membrane layers, the prior art device meets the limitation “wherein the release structure is in communication with the reservoir…”.
However, Schneider does not expressly teach that the device is refillable, or the septum, the backing layer, or the retaining ring of claims 1 and 15-18.
Pinchuk teaches an implantable drug delivery device, which uses a syringe needle connected to a syringe to load, i.e., fill or refill, the reservoir with a liquid-form therapeutic agent, allowing for drug delivery over a period of time in weeks to years rather than painful monthly injections that risk infection [0002-0003; claims 1-35]. Forming the upper surface of the reservoir is a self-sealing polymeric membrane 3 made of three layers, wherein the middle polymer layer 7 is a softer SIBS polymer preferably with a Shore A hardness of 20, while the outer polymer layer 6 and the inner polymer layer 8 can be SIBS polymers preferably with a Shore A hardness of 40 [0016; fig. 1A].
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When a needle is inserted, the softer middle polymer layer quickly recoils back to its original position and effectively seals the needle tract thereby preventing fluid held in the reservoir from escaping out through the needle tract [0017].
The device also comprises a polymeric base 4 having a needle stop feature 9, which can be placed on or bonded to the inside of the surface of the base 4 or formed as part of the base 4, wherein the base 4 is SIBS, silicone rubber, or other suitable polymeric material [0019; fig. 1A]. When using the needle to load, i.e., fill or refill, the reservoir 2, the needle stopper feature 9, which is made of titanium, prevents the needle that passes through the self-sealing membrane 3 from entering into and passing through the base 4 and possibly injuring the body or providing a pin-hole from where liquid-form therapeutic agent can escape [0019].
Forouzandeh, throughout the reference, teaches an implantable and refillable reservoir-based drug delivery system capable of thousands of leak-free refills [abstract]. To overcome existing challenges associated with septum leaking after refill injection punctures, Forouzandeh implements a hollow circular cap with a compression ring fixed on the septum to provide vertical compression, which improves sealing [pg. 3, sec. 2.1; fig. 1].
Regarding the limitation “refillable”, the septum, and the backing layer of claim 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 device taught by Schneider by incorporating the self-sealing polymeric membrane of Pinchuk adjacent to the upper outer surface of the core of Schneider and incorporating the titanium needle stop feature of Pinchuk between the lower outer surface of the core and the surrounding membrane layer. One of ordinary skill in the art would have been motivated to add the self-sealing membrane to allow for refill of therapeutic agent in the implantable device, which would decrease frequency of injections, risk of infections, and increase drug delivery over a prolonged period of time. One of ordinary skill in the art would have been motivated to add the needle stop feature to prevent the needle from entering into and passing through the lower outer surface of the core and possibly injuring the body or providing an escape for therapeutic agent. There is a reasonable expectation of success because both references teach implantable drug delivery devices comprising a reservoir and a backing layer made from olefin copolymers, suggesting that the self-sealing polymeric membrane and needle stop feature of Pinchuk would be compatible with the implantable device of Schneider without perturbing their functions. Further, Schneider teaches additional membrane layers may also be disposed over the first and/or second membrane layers to help further control release of the drug compound [0045].
Regarding the retainer ring recited in claim 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 device taught by the combination of Schneider and Pinchuk by further including a hollow circular cap comprising a compression ring (i.e., retainer ring) fixed on the septum, which would necessarily compress and secure the septum and adjacent release structure against each other, because this technique is known to improve resistance to leaking after refill injection punctures. Applying a known technique to a known method ready for improvement to yield predictable results is the rationale supporting obviousness. See MPEP § 2143 and KSR International Co. V. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385, 1395-97 (2007).
Regarding claim 2: Schneider teaches the device has a generally circular cross-sectional shape [0045].
Regarding claims 3-4: Schneider further discloses the dimensions of the disc-shaped cores are 1 mm thick x 23 mm diameter, equating to a volume of 415.3 mm3 or 0.4153 mL (calculated by Examiner using V = πr²h) [0061; 0065; 0067; claim 5]. While the exemplary cores of Schneider have a volume of 0.4153 mL, which reasonably reads on the instantly claimed volume of about 0.5 mL to about 5 mL, Schneider further teaches that the device can have a diameter of from about 0.5 to about 50 mm and a length of from about 0.5 to about 5 mm [0028], which would result in volumes ranging from about 0.3925 mm3, or 0.0003925 mL, to about 392,500 mm3, or 392.5 mL (calculated by Examiner using V = πr²h). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adjust the core volume within the prior art range, using 0.4153 mL as a starting point for optimization, because Schneider teaches that any volume within this range is suitable for making disc-shaped implantable devices.
Regarding claim 5-8 and 10: Schneider discloses the hydrophobic polymer comprises a semi-crystalline copolymer derived from at least one olefin monomer and at least one polar monomer [claims 10-14]. Ateva® 2861A, which is used in the exemplary core-membrane devices, is an ethylene vinyl acetate copolymer [0047]. Ethylene is recognized as an olefin and vinyl acetate is recognized as a polar monomer, which together make a semi-crystalline olefin copolymer that is hydrophobic in nature [0033-0034].
Regarding claim 9: Schneider teaches that the polar monomer component of the semi-crystalline olefin copolymer constitutes from about 10 wt% to about 45 wt% of the copolymer [claim 14], which reads on the instantly claimed range.
Regarding claim 11: Schneider teaches that the hydrophobic polymer of the membrane polymer matrix 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 [claim 17], which reads on the instantly claimed melt flow index.
Regarding claims 12-14: Schneider teaches that the membrane layers, i.e. release structure, are formed by melt compounding Ateva® 2861A and polyethylene glycol (PEG) [0061; 0065; 0067], which is a hydrophilic polymer [claim 27], suggesting that water-soluble PEG is distributed within the membrane layers.
Regarding claim 15: The Shore A hardnesses of the septum polymer layers fall within the instantly claimed range of about 40 or less. The Examiner notes that the Pinchuk also teaches the inner polymer layer can be omitted from the self-sealing membrane, or the self-sealing membrane can be formed from a single polymer layer [0018].
Regarding claim 16: The septum comprises SIBS, which is a polyolefinic copolymer material having a triblock polymer backbone comprising polystyrene-polyisobutylene-polystyrene [0018], which reads on the instantly claimed styrene block copolymer.
Regarding claim 17: The three-layer self-sealing membrane reads on the instantly claimed multi-layered septum.
Regarding claim 18: The titanium of the needle stop feature reads on the instantly claimed metal. The Examiner notes that Pinchuk also teaches it can also be stainless steel or a hard plastic that does not interfere with medical imagining technologies [0019].
Together, the implantable device and refillable device taught by the prior art combination reads on the following elected species of the instant claims: the hydrophobic polymer is ethylene vinyl acetate, wherein the olefin is ethylene and the polar monomer is vinyl acetate, and the hydrophilic compound and polymer is polyethylene glycol.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US-PGPUB 20190358166A1; published: 11/28/2019; IDS of 12/29/2023) in view of Pinchuk et al. (WO2021163159A1; published: 08/19/2021; PTO-892 of 02/20/2025) and Forouzandeh et al. (Micromachines, vol. 11, pg. 1-17; published: 06/30/2020; PTO-892 of instant action), as applied to claims 1-18 above, and further in view of Osato et al. (Colloid Polym. Sci., vol. 294, pg. 537-543; published: 12/23/2015; PTO-892 of 02/20/2025) and DuPont (pg. 1-6; published: 01/2012; PTO-892 of 02/20/2025).
The combination of Schneider, Pinchuk, and Forouzandeh teaches the invention(s) of claims 1-18 as discussed in detail above and further incorporated herein.
Claim 15 is further rejected herein to demonstrate that Applicant’s elected species of septum material, ethylene vinyl acetate, is also obvious in view of the prior art.
While Pinchuk teaches that the self-healing polymeric membrane, corresponding to the instantly claimed septum, can be made of SIBS, silicon rubber, or other suitable polymeric materials with preferred Shore A hardnesses ranging from 20-40, the prior art combination does not expressly teach that the self-healing polymeric membrane comprises ethylene vinyl acetate.
Osato teaches that poly(ethylene-co-vinyl acetate) with 42 wt% of vinyl acetate exhibits automatic self-healing properties at room temperature and has a glass transition temperature (Tg) lower than room temperature [pg. 542]. Self-healing behavior is reduced by crystallization, suggesting that healing behavior is observed in polymers with a low degree of crystallinity when the Tg of the material is lower than the ambient temperature [pg. 542].
DuPont teaches that ELVAX® 40W has a Shore A-2 hardness of 40 and a vinyl acetate content of 40.0% [pg. 3]. While DuPont does not specify that the vinyl acetate content for ELVAX® 40W is by weight percent, other ELVAX® ethylene vinyl acetates on the product sheet do specify vinyl acetate content by weight [pg. 5, bottom table], indicating that the percentage of vinyl acetate content reported for ELVAX® 40W reflects weight percent.
Regarding the elected species of septum material, ethylene vinyl acetate, of claim 15: 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 self-sealing polymeric membrane taught by the combination of Schneider, Pinchuk, and Forouzandeh by substituting the tri-layer SIBS-based membrane with the self-healing ethylene vinyl acetate copolymer taught by Osato, such as the commercially available ELVAX® 40W copolymer taught by DuPont. There is a reasonable expectation of success because both SIBS and ELVAX®40W are recognized by the prior art as self-healing olefinic copolymers with a Shore A hardness of 40 or less, suggesting that they could be used for the very same purpose without perturbing the function of the self-sealing polymeric membrane, Pinchuk teaches that the self-sealing polymeric membrane can be formed from a single polymer layer, and Schneider teaches that ELVAX®40W is a material that is suitable for use in the drug delivery device [0035]. Further, ELVAX®40W would be expected to retain the self-healing property of the polymeric membrane because Osato teaches that ethylene vinyl acetates with a similar vinyl acetate content exhibit self-healing properties at room temperature and above, which would include human body temperature.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Schneider (US-PGPUB 20190358166A1; published: 11/28/2019; IDS of 12/29/2023) in view of Pinchuk et al. (WO2021163159A1; published: 08/19/2021; PTO-892 of 02/20/2025) and Forouzandeh et al. (Micromachines, vol. 11, pg. 1-17; published: 06/30/2020; PTO-892 of instant action), as applied to claims 1-18 above, and further in view of Mischke et al. (Cochrane Database of Systematic Reviews, pg. 1-90; published: 2014; PTO-892 of 02/20/2025)
The combination of Schneider, Pinchuk, and Forouzandeh teaches the invention(s) of claims 1-18 as discussed in detail above and further incorporated herein.
Claim 18 is further rejected herein to demonstrate that Applicant’s elected species of backing layer of claims 18 and 19, metal mesh and stainless steel fibers, are also obvious in view of the prior art.
While Pinchuk teaches stainless steel as an alternative metal for making the needle stop feature, the prior art combination does not expressly teach that the needle stop feature of Pinchuk comprises a metal mesh or stainless steel fibers.
Mischke teaches that stainless steel wire weave provides increased resistance to needle penetration, as demonstrated by mechanical puncture tests with a needle penetration machine [pg. 6].
Regarding claims 18 and 19: 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 needle stop feature taught by the combination of Schneider, Pinchuk, and Forouzandeh by substituting the titanium with stainless steel, which is also taught by Pinchuk as a suitable alternative metal for making the needle stop feature. One of ordinary skill in the art would have been motivated to use stainless steel in mesh form because Mischke teaches stainless steel wire weave has desirable mechanical properties, such increased resistance to needle penetration. There is a reasonable expectation of success because Pinchuk teaches that stainless steel is a suitable material to use as the needle stop feature, suggesting its biocompatibility and suitability for use in implantable and refillable drug delivery device taught by the prior art combination.
Claims 1-18 and 20 Schneider (US-PGPUB 20190358166A1; published: 11/28/2019; IDS of 12/29/2023) in view of Pinchuk et al. (WO2021163159A1; published: 08/19/2021; PTO-892 of 02/20/2025) and Forouzandeh et al. (Micromachines, vol. 11, pg. 1-17; published: 06/30/2020; PTO-892 of instant action), as applied to claims 1-18 above, and further in view of Chan et al. (WO02062352A2; published: 08/19/2021; PTO-892 of 05/22/2024).
The combination of Schneider, Pinchuk, and Forouzandeh teaches the invention(s) of claims 1-18 as discussed in detail above and further incorporated herein.
The prior art combination does not expressly teach that the drug compound includes one or more bisphosphonates as recited in claim 20.
Chan teaches devices and methods for the delivery of a drug formulation comprising a bisphosphonate, which is provided parenterally in a sustained release dosage form, i.e. as an injected matrix or stored within a drug delivery device [abstract]. There is great need for devices and methods for effective and practical long-term management of bone density [pg. 5]. In a specific embodiment, the dosage form may be implanted or injected into a site in the body and a conduit can be used to transport the formulation from the dosage form for release at a site in the body distal form the implantation site [abstract]. Suitable materials for the reservoir include non-reactive polymers such as polyethylene vinyl acetate and polystyrene, among others, and biocompatible metals such as stainless steel and titanium, among others [pg. 29].
Regarding claim 20: 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 implantable and refillable device taught by the combination of Schneider, Pinchuk, and Forouzandeh by substituting the drug compound with the drug formulation comprising bisphosphate taught by Chan. One of ordinary skill in the art would have been motivated to use the device taught by prior art combination to improve the long-term management of bone density, as taught by Chan, using advantages such as a refillable implant. There is a reasonable expectation of success because both Chan and the combination of Schneider, Pinchuk, and Forouzandeh teach the use of implantable devices for sustained delivery of therapeutics, wherein the implantable device comprises materials such as ethylene vinyl acetate, polystyrene, stainless steel, and titanium.
Claims 1-18 and 24 Schneider (US-PGPUB 20190358166A1; published: 11/28/2019; IDS of 12/29/2023) in view of Pinchuk et al. (WO2021163159A1; published: 08/19/2021; PTO-892 of 02/20/2025) and Forouzandeh et al. (Micromachines, vol. 11, pg. 1-17; published: 06/30/2020; PTO-892 of instant action), as applied to claims 1-18 above, and further in view of Clark et al. (Neuropsychopharmacology, vol 45, pg. 1860-1869; published: 06/09/2020; PTO-892 of 02/20/2025) and Barnwal et al. (Ther. Adv. in Psychopharmacol., vol. 7, pg. 119-134; published: 12/19/2016; PTO-892 of 02/20/2025).
The combination of Schneider, Pinchuk, and Forouzandeh teaches the invention(s) of claims 1-18 as discussed in detail above and further incorporated herein.
The prior art combination does not expressly teach that the drug compound includes one or more antipsychotics as recited in claim 24.
Clark teaches opioid antagonists, including the mixed kappa antagonist and mu partial agonist buprenorphine, have a significant effect in treating symptoms in patients with the chronic psychiatric syndrome schizophrenia [abstract; pg. 1860].
Barnwal teaches that one of the useful drugs for opioid dependence is the partial opioid agonist buprenorphine with a much better safety profile than methadone [pg. 119]. However, buprenorphine-prescribing doctors and regulatory agencies are increasingly concerned about the compliance and diversion of buprenorphine, which has worsened with its extensive use [pg. 122]. Diversion, nonadherence, and noncompliance with medication remain troublesome issues that require innovative solutions and diligence among clinicians [pg. 122-123]. To address these problems, implantable formulations of buprenorphine were developed [pg. 123]. Probuphine® is a polymeric matrix composed of ethylene vinyl acetate and buprenorphine in the form of implants, that are implanted subdermally in office practice and deliver the active drug over 6 months and is seen as a suitable alternative to daily or alternate day buprenorphine, which can eliminate the need for daily supervision, minimize fluctuations in plasma concentrations, and reduce patient visits to the clinic or pharmacy [abstract].
Regarding claim 24: 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 implantable and refillable device taught by the combination of Schneider, Pinchuk, and Forouzandeh by substituting the drug compound with the anti-schizophrenic drug buprenorphine taught by Clark based on the teachings of Barnwal. One of ordinary skill in the art would have been motivated to use the device taught by the prior art combination to deliver buprenorphine to schizophrenic patients over a sustained period of time with the added benefit of refilling the treatment as needed. There is a reasonable expectation of success because Barnwal teaches the delivery of buprenorphine over extended periods of time using an ethylene vinyl acetate-based implant, suggesting compatibility with the implantable and refillable device taught by the prior art combination.
Response to Arguments
Applicant’s arguments submitted on 03/03/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered in so far as they apply to the new or modified rejections of the instant Office action, but were not found to be persuasive.
Applicant argues that neither Schneider nor Pinchuk teaches the instantly claimed retainer ring feature. As discussed in detail in the prior art rejections above, this deficiency is cured by Forouzandeh, which teaches that fixation of a compression ring (i.e., retainer ring) on a self-healing septum in a drug delivery device is a known technique to improve resistance to leaking after refill injection punctures, which is an art-recognized challenge.
In view of the foregoing, the prior art rejections of record are maintained.
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 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/948,271. Although the claims at issue are not identical, they are not patentably distinct from each other because they are drawn to the same implantable and refillable device for delivering a drug compound.
Both the instant claims and the claims of App. ‘271 recite an implantable and refillable device comprising a reservoir, a release structure, a septum, a retainer ring, and a backing layer. The claims overlap almost entirely, and the only difference lies in the intended use of the device of App. ‘271 “for delivering a contraceptive agent”. The contraceptive agent recited in the claims of App. ‘271 is a species of the instantly claimed drug compound, and a species anticipates a claim to a genus. Note: MPEP 2131.02(I). Further, the recitation “for delivering a drug compound” recited in the instant claims is an intended use of the claimed invention. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the device recited in the claims of App. ‘271 is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
This is a provisional nonstatutory double patenting rejection.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/948,271, as applied to claims 1-19 above, and further in view of Chan et al. (WO02062352A2; published: 08/19/2021; PTO-892 of 05/22/2024).
The claims of App. ‘271 recite the invention(s) of claims 1-19 as discussed in detail above and further incorporated herein.
The claims of App. ‘271 do not recite that the drug compound includes one or more bisphosphonates.
The teachings of Chan are as set forth above and further incorporated herein.
Regarding claim 20: It would have been obvious to one of ordinary skill in the art to modify the device recited in the claims of App. ‘271 by substituting the contraceptive agent with the drug formulation comprising bisphosphate taught by Chan. One of ordinary skill in the art would have been motivated to use the device recited in the claims of App. ‘271 to improve the long-term management of bone density, as taught by Chan, using advantages such as a refillable implant. There is a reasonable expectation of success because both Chan and the claims of App. ‘271 teach or recite the use of implantable devices for delivery of therapeutics, wherein the implantable device comprises materials such as ethylene vinyl acetate, polystyrene, metals.
This is a provisional nonstatutory double patenting rejection.
Claims 1-19 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 17/948,271, as applied to claims 1-19 above, and further in view of in view of Clark et al. (Neuropsychopharmacology, vol 45, pg. 1860-1869; published: 06/09/2020; PTO-892 of 02/20/2025) and Barnwal et al. (Ther. Adv. in Psychopharmacol., vol. 7, pg. 119-134; published: 12/19/2016; PTO-892 of 02/20/2025).
The claims of App. ‘271 recite the invention(s) of claims 1-19 as discussed in detail above and further incorporated herein.
The claims of App. ‘271 do not recite that the drug compound includes one or more antipsychotics.
The teachings of Clark and Barnwal are as set forth above and further incorporated herein.
It would have been obvious to one of ordinary skill in the art to modify the implantable and refillable device recited in the claims of App. ‘271 by substituting the contraceptive agent with the anti-schizophrenic drug buprenorphine taught by Clark based on the teachings of Barnwal. One of ordinary skill in the art would have been motivated to use the device recited in the claims of App. ‘271 to deliver buprenorphine to patients over a sustained period of time, as taught by Barnwal. There is a reasonable expectation of success because both Barnwal and the claims of App. ‘271 teach or recite the delivery of drug compounds using ethylene vinyl acetate-based implants.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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