DETAILED ACTION
Claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, 34, and 42 are pending. Of these, claim 42 is withdrawn as directed to a nonelected invention. Therefore, claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34 are under consideration on the merits.
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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/8/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/8/26 was filed prior to the mailing date of a first Action on the merits after the filing of an RCE. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, it was considered by the Examiner.
Status of the Rejections
A new 112(d) rejection is applied.
The 103 rejections over Swarner as primary reference are withdrawn in view of the amendment, but new rejections incorporating the teachings of two new primary references are applied as detailed below.
The double patenting rejection is withdrawn in view of the filing and approval of a terminal disclaimer, but a new rejection was necessitated by the filing of a new copending application.
Claim Interpretation
Base claims 1 and 22 recite that the first active agent “is for the treatment or prevention of HIV.” Therefore, the claims read on the prevention of HIV, wherein “prevention” would be interpreted by the skilled artisan according to its plain and ordinary meaning as encompassing the total prevention of HIV transmission. The “CDC Recommends New Injectable HIV PrEP” article discloses that the U.S. Food and Drug Administration has approved the injectable prescription medication lenacapavir for HIV pre-exposure prophylaxis (PrEP), and that the Centers for Disease Control (CDC) has reviewed the evidence on lenacapavir from two clinical trials that demonstrated strong efficacy in preventing HIV infection, and strongly recommends lenacapavir administered every six months as a subcutaneous injection for HIV PrEP therapy) see 1st and 2nd paragraphs). The background section of the present specification also notes that administration of the antiretroviral drug tenofovir has demonstrated success as a PrEP therapy (paragraph 5 as published). Therefore, the skilled artisan would conclude that the present specification in view of the knowledge of the art adequately enables and describes the full scope of the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 recites that the more than one active agent includes first and second active agents that are different from each other, but base claim 1 already requires the presence of two or more active agents, wherein the first active agent is for the treatment or prevention of HIV and the second active is for a different indication, which implies that the first and second active agents are different from each other. Therefore, claim 13 fails to limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34 are rejected under 35 U.S.C. 103 as unpatentable over Stewart et al. (Pharmaceutics 2020, 12, 105; published 1.28.20) in view of Swarner et al. (US Pat. Pub. 2018/0235900; of record in IDS).
As to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34, Stewart discloses hollow biodegradable subcutaneous implants for prolonged drug delivery from an inner reservoir, the implant formed from extruded polylactic acid, and comprising a non-porous coating of polycaprolactone 6506 with a thickness of 0.11 mm (i.e., 110 microns, which is within the ranges of claims 1-2, 22, and 31), wherein “polycaprolactone” is the elected species of polymer membrane of claims 1, 15, 22, and 29 and which is also a homopolymer of claims 17 and 27, polycaprolactone 6506 also having a molecular weight of 50,000 Da, which is within the ranges of claims 16 and 30 (Abstract and page 3). Stewart teaches that the polycaprolactone coating over the implant acts as a rate controlling membrane that is capable of providing sustained drug release via diffusion through the membrane over a period of 300 days, while equivalent non-coated implants released all of the drug within only four days, and concludes that such polycaprolactone coatings could be an ideal approach for applications requiring drug release over long periods of time such as drugs for the treatment of chronic conditions or pre-exposure prophylaxis of HIV (page 12). The release profile showed zero order kinetics over the first 60 days as recited by claim 22 (Figure 9). Stewart teaches that the use of biodegradable polymers in subcutaneous implants is advantageous because they do not require surgical removal and instead degrade naturally to products that are easily excreted by the body (paragraph bridging pages 1 and 2).
As to claims 21 and 32, the implant may have a generally cylindrical shape (Figure 3) and have a length of 40 mm, which is within the recited range (Figure 2).
Regarding claims 11 and 24, Stewart discloses incorporating methylene blue, ibuprofen sodium, or ibuprofen acid as the active agent, which are small molecules (Abstract).
As to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34, Stewart does not further expressly disclose that the two different active agents are present in combination, one of which is for the treatment of HIV and the other for another indication as recited by claims 1, 13, and 22, or that the polycaprolactone membrane is extruded as opposed to coated as recited by claims 1 and 22, nor that the active agent formulation comprises an excipient (claims 3 and 25) which is the elected species, i.e., castor oil of claim 12, or that the device fragments at one to 6 months after the active agents are depleted from the device (claim 34).
Swarner discloses a reservoir device comprising an active agent disposed within a reservoir defined by a porous polymer membrane to allow diffusion of the active when the device is positioned subcutaneously in the body of a subject (paragraphs 4 and 11). The device may comprise an active agent such as a therapeutic, a preventative, or a contraceptive, and more than one active agent may be used in combination as recited by claims 1 and 13, and the active may be a small molecule (paragraph 44), such as the HIV medication tenofovir Alafenamide Fumarate (paragraph 44), and the use of tenofovir Alafenamide Fumarate in combination with a contraceptive meets the requirement of claims 1 and 22 that the first active is for treatment or prevention of HIV and the second active is for preventative indications and/or therapeutic needs other than HIV. The polymer membrane may comprise polycaprolactone and may have a molecular weight of 15,000-80,000 Da, which is within the range of claims 16 and 30 (paragraphs 42 and 45). The device allows for zero order release kinetics for the active agents and releases the actives for 60 days as recited by claim 22 (paragraph 42). The reservoir may comprise an excipient along with the active agents (paragraph 43) and which may be castor oil, which is the elected species of excipient (Table 2). The device may be in the shape of a cylinder with a length of 40 mm, which is within the recited range (paragraphs 43 and 53). Regarding claim 34, the device may fragment at month 3, which is one month after the 60 days to depletion of the active, which reads on the 1-6 month range recited by the claim (Table 1 on page 6).
As to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the Stewart implantable reservoir device by selecting the HIV medication tenofovir Alafenamide Fumarate in combination with another active agent such as a contraceptive as the drug in the reservoir, because Stewart does not limit the identity of the drug and in fact teaches that its implant is a good candidate for delivery of drugs generally that benefit from release over a long period of time which would include chronic conditions or chronic prophylactic needs such as pre-exposure HIV prophylaxis and contraception, and Swarner teaches that combinations of medications such as tenofovir Alafenamide Fumarate and a contraceptive are suitable active agents for release from a subcutaneous reservoir device comprising a polycaprolactone membrane, such that the skilled artisan reasonably would have expected that these drugs could successfully and desirably be delivered from the Stewart device over a prolonged period of time. Such a modification is merely the simple substitution of one known element for another according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Regarding the recitation of the base claims that the polymer membrane is extruded, this limitation puts the claims in the form of product by process claims such that their patentability is determined by their structure and not by the manner in which it is formed (i.e., via extrusion). “[E]ven though product-by-process claims are limited by and defined by the process, 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, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Here, there is no evidence of record that the structure of the coated polycaprolactone layer is different in a nonobvious manner from the extruded membrane of the present claims.
Alternatively, it would have been prima facie obvious to form the polycaprolactone membrane via extrusion, because Stewart itself teaches that the polylactide biodegradable polymer layer of the implant is produced via an extrusion process, such that the skilled artisan reasonably would have expected that the polycaprolactone biodegradable polymer layer also could be produced via extrusion.
As to claims 3, 12 and 25, it further would have been prima facie obvious to incorporate castor oil into the reservoir with the active agents because Swarner expressly teaches that castor oil is a suitable excipient for use in the drug reservoir of a subcutaneous implant comprising a polycaprolactone membrane, such that the skilled artisan reasonably would have expected that it could serve as an excipient for the actives in the reservoir of the Stewart subcutaneous implant comprising a polycaprolactone membrane.
Regarding claim 34, it further would have been prima facie obvious to configure the implant device to fragment at month 3, which is one month after the 60 days to depletion of the active and which reads on the 1-6 month range recited by the claim, because Swarner expressly teaches that this is a suitable fragmentation time for a subcutaneous implant that is intended to biodegrade over time.
Claims 4 and 23 are rejected under 35 U.S.C. 103 as unpatentable over Stewart et al. (Pharmaceutics 2020, 12, 105; published 1.28.20) in view of Swarner et al. (US Pat. Pub. 2018/0235900; of record in IDS) as applied to claims 1-3, 11-13, 15-17, 21-22, 24-25, 27, 29-32, and 34 above, and further in view of Sidman (US Pat. No. 4,450,150; of record in IDS).
The teachings of Stewart and Swarner are relied upon as discussed above, but they do not further expressly disclose that the contraception agent serving as the second active agent is levonorgestrel as recited by claims 4 and 23.
Sidman teachings implantable drug delivery depots comprising fertility control agents for delivery such as the contraceptive levonorgestrel (Abstract and column 9, 5th full paragraph).
As to claims 4 and 23, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the implantable reservoir device of Stewart and Swarner as combined supra by selecting levonorgestrel as the type of contraceptive, because Swarner teaching selecting a contraceptive as an active and places no limitations on the identity of the contraceptive, and Sidman teaches that levonorgestrel is a suitable contraceptive for release from an implantable reservoir device, such that the skilled artisan reasonably would have expected that it could be used as the contraceptive in the Steward implantable reservoir device. Such a modification is merely the combining of known prior art elements according to known methods to yield predictable results, which is prima facie obvious. MPEP 2143.
Response to Applicant’s Arguments
Applicant’s arguments will be addressed to the extent they may be relevant to the new grounds of rejection.
Applicant argues that Swarner’s disclosure is insufficient to suggest the claimed combination of a first active for HIV and a second active for an indication other than HIV, claiming that Swarner’s language is ambiguous and could refer to a single active that serves a combination of purposes rather than distinct active agents in combination.
In response, this argument is not persuasive because paragraph 44 of Swarner states that the active may be “an antibody, a small molecule, a protein, and/or a peptide,” wherein the use of “and/or” clearly implies that there may be two distinct classes of active agents.
Claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34 are rejected under 35 U.S.C. 103 as unpatentable over Johnson et al. (US Pat. Pub. 2026/0034339).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
As to claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34, Johnson discloses a reservoir device defined by an extruded biodegradable permeable polymer membrane having a thickness of 45-300 microns (reading on the ranges of claims 2 and 31) and comprising polycaprolactone homopolymer (claims 15, 17, 27, and 29-30) having a molecular weight of 15,000-140,000 Da (reading on the ranges of claims 16 and 30), the membrane further comprising an active agent formulation comprising an excipient (claims 3 and 25) that is castor oil (claim 12), wherein the active agent formulation comprises a small molecule (claims 11 and 24) such as tenofovir alafenamide fumarate (claims 4 and 23), wherein a second active agent also may be present such as naltrexone (claims 13 and 23), and wherein the device has a cylindrical shape with a length of between 10 mm and 50 mm (claims 21 and 31), the device allowing for diffusion of the active through the polymer membrane with zero order release kinetics for a time period of at least 60 days when positioned subcutaneously in the body of a subject (claim 22), and wherein the polymer membrane may be configured such that it undergoes fragmentation at about one to 6 months after the active agent is depleted from the device (claim 34) (see paragraphs 98 and 120 and claims 1-2, 5-7, 8-10, and 12-13 of Johnson). Johnson does not disclose forming pores in the polymer membrane.
As to claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34, Johnson does not further expressly disclose a specific embodiment wherein the active agent is a small molecule, the polymer is polycaprolactone, and the excipient is castor oil as was elected by Applicant.
As to claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34, it would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the present invention to modify the teachings of Johnson by selecting polycaprolactone as the polymer membrane, castor oil as the excipient, and a small molecule as the active agent, because Johnson expressly teaches that the foregoing ingredients are suitable for use as the polymer membrane, excipient, and small molecule respectively. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301). MPEP § 2144.07.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-4, 11-13, 15-17, 21-25, 27, 29-32, and 34 are rejected on the ground of nonstatutory double patenting as unpatentable over all claims of US Pat. Appl. No. 19/354,918 and in view of Stewart et al. (Pharmaceutics 2020, 12, 105) where indicated below.
The teachings of the secondary reference is relied upon as discussed above.
The reference claims recite a reservoir device comprising an active agent formulation within a reservoir defined by a biodegradable permeable polymer membrane having a thickness of about 45-300 microns and which allows for diffusion of the active when positioned subcutaneously in a body of a subject via zero order release kinetics for at least 60 days when positioned subcutaneously, wherein the active may comprise a combination of tenofovir alafenamide fumarate and naltrexone, the reservoir further comprising castor oil as an excipient, wherein the membrane may comprise polycaprolactone homopolymer having a molecular weight of 15,000-140,000 Da, the device having a cylindrical shape with a length between about 10-50 mm. The reference claims do not recite the presence of pores.
Although the reference claims do not expressly recite that the polymeric membrane is extruded, this limitation puts the claims in the form of product by process claims such that their patentability is determined by their structure and not by the manner in which it is formed (i.e., via extrusion). “[E]ven though product-by-process claims are limited by and defined by the process, 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, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Here, there is no evidence of record that the structure of the coated polycaprolactone layer is different in a nonobvious manner from the extruded membrane of the present claims.
Alternatively, it would have been prima facie obvious to form the polycaprolactone membrane via extrusion, because Stewart teaches that biodegradable polymer layers of a drug reservoir implant can be produced via an extrusion process, such that the skilled artisan reasonably would have expected that the polycaprolactone layer also could be produced via extrusion.
Although the reference claims do not specify that the polymer membrane is configured to undergo fragmentation at about 1-6 months after depletion of the active from the device, the reference device will be capable of undergoing fragmentation within said time period because it comprises the same ingredients and structural configuration that are recited by the claims. Additionally, the skilled artisan would have been motivated to select a fragmentation within the claimed range in light of Swarner’s teaching that a reservoir device comprising a polycaprolactone membrane for subcutaneous release of an active suitably can possess a fragmentation period within the presently recited time range.
The claims are directed to an invention not patentably distinct from the claims of the copending application. Specifically, see above.
The USPTO may not institute a derivation proceeding in the absence of a timely filed petition. The U.S. Patent and Trademark Office normally will not institute a derivation proceeding between applications or a patent and an application of common ownership (see 37 CFR 42.411). The copending application, discussed above, would be prior art to the noted claims under 35 U.S.C. 102(a)(2) if the patentably indistinct inventions were not commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention.
In order for the Examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(c)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 U.S.C. 102(c) and 37 CFR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the inventions were commonly owned or deemed to be commonly owned as of the effective filing date under 35 U.S.C. 100(i) of the claimed invention will preclude a rejection under 35 U.S.C. 102 or 103 based upon the commonly assigned case.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GAREN GOTFREDSON whose telephone number is (571)270-3468. The examiner can normally be reached on M-F 9AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 5712720827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GAREN GOTFREDSON/Examiner, Art Unit 1619
/ANNA R FALKOWITZ/ Primary Examiner, Art Unit 1600
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