DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application filed 08/06/2024, is a 371 filing of PCT/US2023/012930, filed 02/13/2023, which claims benefit to US Provisional Application No. 63/309,151, filed 02/11/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 5, 7-10, 14-21, and 23-24, in the reply filed on 06/12/2026 is acknowledged. Applicant’s species election without traverse of rifabutin, DMSO, PLGA, Kolliphor® HS 15, and tocopherol is also acknowledged. Accordingly, claims 7-9 are withdrawn as being drawn to a non-elected species of the hydrophobic additive and claims 25-26 are withdrawn as being drawn to a non-elected invention. Additionally, the non-elected species are withdrawn from their corresponding claim.
Status of Claims
Receipt of Remarks/Amendments filed on 06/12/2026 is acknowledged. Claims 4, 6, 11-13, 22, and 27-50 are canceled. Claims 7-9 and 25-26 are withdrawn according to the election/restriction discussed above. Claims 1-3, 5, 10, 14-21, and 23-24 are examined on the merits herein.
Claim Objections
1. Claims 14-21 and 23-24 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot reference back to another multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 14-21 and 23-24 have not been further treated on the merits.
2. Claim 10 is objected to because of the following informalities: “Vitamin E derivatives” unnecessarily capitalizes the word Vitamin, please remove capitalization. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Benhabbour S. et al. (US 20240285769 A1, 08/29/2024, effectively filed on 06/30/2021, PTO-892), hereinafter Benhabbour, as evidenced by Science Direct (2026). Pluronic - an overview, sciencedirect topics. (PTO-892), hereinafter Science Direct.
Benhabbour discloses injectable, biodegradable and removable polymer based drug suspension for ultra-long-acting drug delivery (abstract).
Regarding claim 1: The polymer-based injectable suspension comprises a polymer or a combination of polymers and stabilizer; a solvent or a combination of solvents; and a drug in a suspension ([0006]; claim 1). The suspension further comprises one or more hydrophobic molecules or components (i.e., additive) ([0006]; claim 4). The polymer is a biodegradable polymer (claim 7) and the solvent is a water-miscible biocompatible solvent ([0006]; claim 9). Rate-controlling additives such as Pluronic 61 are added into the formulations of specific examples ([0034]; Table 6), which reads on an amphiphilic additive as evidenced by Science Direct. The suspension is configured to provide ultra-long-acting drug release of about 90 days or more (claim 17).
Regarding claim 2: The stable polymer-based injectable suspension forms a biodegradable in-situ forming implant (ISFI) when injected into a subject (claim 3) and the suspension is configured to provide ultra-long-acting drug release of about 90 days or more (claim 17).
Regarding claim 3: As discussed above, specific formulations comprise rate-controlling additives such as Pluronic 61 ([0034]; Table 6), which is amphiphilic as evidenced by Science Direct.
Regarding claim 5: Also discussed above, the suspensions comprise one or more hydrophobic molecules or components (i.e., additive) ([0006]; claim 4). While it is not explicitly taught that hydrophobic additives increase the release of the drug or active, it is deemed inherent that a hydrophobic component would increase the release of the drug since the composition of the prior art is identical to the composition of claims 1 and 2, meaning the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Claims 1-2, 5, and 10 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Chen G. et al. (US 20050281879 A1, 12/22/2005, PTO-892), hereinafter Chen, as evidenced by Kaye AD. et al. (2025). Vitamin E (α-Tocopherol): Emerging Clinical Role and Adverse Risks of Supplementation in Adults. Cureus. 17(2) (PTO-892).
Chen discloses injectable depot gel compositions that provide an excipient for modulating a release rate and stabilizing beneficial agents (abstract).
Regarding claim 1: The injectable compositions releases a beneficial agent of both a short duration and a prolonged duration (i.e., long-acting) ([0013]). The composition comprises a gel vehicle comprising a bioerodible, biocompatible polymer and a water-immiscible solvent; a beneficial agent (i.e., active agent) dissolved or dispersed in the gel vehicle; and an excipient for modulating a release rate, wherein the excipient stabilizes the beneficial agent by offsetting the effects of degradation of the polymer ([0013]; claim 1). The excipient may comprise an antioxidant such as tocopherol ([0016]; [0037]; [0072]; claims 5 and 8; Example 15), which reads on a hydrophobic additive as evidenced by the instant application (see instant claim 10). The solvent is necessarily a biocompatible solvent given the composition’s use in vivo (Ex. 15).
Regarding claim 2: The injectable depot gel composition is used for sustained delivery of a beneficial agent to a subject over a duration of between about twenty-four hours to about twelve months ([0027]; claim 47). In vivo administration studies were performed in rats (Ex. 10).
Regarding claims 5 and 10: As discussed above, the excipient is tocopherol, also known as vitamin E as evidenced by Kaye ([0016]; [0037]; [0072]; claims 5 and 8; Example 15). Regarding the ability of tocopherol to increase the release of the drug, such a property would have been inherent to the overall composition since the composition of the prior art is identical to the composition of claims 1 and 2, meaning the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Claims 1-3 and 5 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Venkitachalam P. et al. (WO 2020089942 A2, 05/07/2020, PTO-892), hereinafter Venkitachalam, as evidenced by Aurorium (2026). Dibutyl Sebacate (DBS) NF. (PTO-892), hereinafter Aurorium.
Regarding claim 1: Venkitachalam discloses a liquid injectable composition which may be in the form of an extended release liquid injectable dosage form (claims 1 and 25). The composition comprises (a) at least one surfactant; (b) at least one gel strength enhancer; (c) at least one solvent; (d) optionally release retarding agent(s); (e) optionally stabilizing agent(s); (f) optionally pharmaceutical excipient(s); and (g) active pharmaceutical ingredient(s) (API) (abstract; claim 1). In a specific embodiment, the release retarding agent is present and comprises at least one of a polymer and lipid (claims 10 and 11), specific embodiments comprise polylactide co glycolide (PLGA) as said polymer (claim 12; Examples 3.2, 3.5-3.11, 4.3-4.5; Tables 4, 8, and 11), which reads on a biodegradable polymer as evidenced by the instant application (see instant claim 18). The solvent is necessarily a biocompatible solvent given the composition’s use in treating a subject (abstract). The above surfactant reads on an amphiphilic additive given the art recognized definition of a surfactant. The gel strength enhancer is a lipophilic liquid and includes at least one of fatty acid, salt of fatty acid, fatty acid esters, medium chain triglycerides, glycerides, and propylene glycol derivative of medium chain triglycerides (claim 8; p. 10, para. 2), several of which read on hydrophobic additives. In a specific embodiment the gel enhancer comprises dibutyl sebacate (claim 9, Examples 3.2, 3.5 and 3.11), which is a hydrophobic additive as evidenced by Aurorium.
Regarding claim 2: The liquid injectable dosage is capable of forming a gel in situ when in contact with aqueous fluid and releases the one or more active pharmaceutical ingredients over a period of time (claim 25).
Regarding claim 3: As discussed above, the composition comprises a surfactant (abstract; claim 1), which reads on an amphiphilic additive.
Regarding claim 5: As discussed above, the composition comprises a gel strength enhancer which is a lipophilic liquid and includes at least one of fatty acid, salt of fatty acid, fatty acid esters, medium chain triglycerides, glycerides, and propylene glycol derivative of medium chain triglycerides (claim 8; p. 10, para. 2) such as dibutyl sebacate (claim 9, Examples 3.2, 3.5 and 3.11). Regarding the ability of such hydrophobic additives to increase the release of the drug, such a property would have been inherent to the overall composition since the composition of the prior art is identical to the composition of claims 1 and 2, meaning the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
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, 5, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Venkitachalam P. et al. (WO 2020089942 A2, 05/07/2020, PTO-892), hereinafter Venkitachalam, as evidenced by Aurorium (2026). Dibutyl Sebacate (DBS) NF. (PTO-892), hereinafter Aurorium, and Kaye AD. et al. (2025). Vitamin E (α-Tocopherol): Emerging Clinical Role and Adverse Risks of Supplementation in Adults. Cureus. 17(2) (PTO-892).
The teachings of Venkitachalam and Aurorium are discussed above, as are the rejections of claims 1-3 and 5.
Venkitachalam further teaches a specific embodiment in which a stabilizing agent is present and may comprise tocopherol (claims 16-17; p. 11, para. 1), which also reads on a hydrophobic additive, specifically that of claim 10. Tocopherol is an active form of vitamin E as evidenced by Kaye.
The teachings of Venkitachalam differ from that of the instant invention in that Venkitachalam doesn’t explicitly teach wherein the hydrophobic additive is tocopherol, as defined in claim 10 and elected by Applicant.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate tocopherol into the specific compositions of Venkitachalam since tocopherol is known and routine in such compositions. One of ordinary skill in the art would have been specifically motivated to incorporate tocopherol into the composition since it is a known and effective stabilizing agent which would reasonably provide the composition of Venkitachalam with increased stability. Additionally, one skilled in the art could have selected tocopherol and combined it with the polymer containing composition of Venkitachalam by known methods with no change in either’s respective function and the combination would have yielded predictable results to one of ordinary skill in the art.
One of ordinary skill in the art would have had a reasonable expectation of success in making the above modification since tocopherol is taught and encouraged by Venkitachalam.
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.
1. Claims 1-3, 5, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 9, 17 of copending Application No. 18/571,412 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a stable polymer-based injectable suspension, the stable polymer-based injectable suspension comprising: a polymer; a solvent; and a drug in a suspension (copending claim 1). The stable polymer-based injectable suspension comprises one or more hydrophobic molecules or components (i.e., additives) (copending claim 4). The polymer is a biodegradable polymer (copending claim 7) and the solvent is a water-miscible biocompatible solvent (claim 9). The suspension is configured to provide ultra-long-acting drug release of about 90 days or more (copending claim 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5, and 10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/391,998 in view of Chen. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Chen.
The copending claims recite a controlled release drug delivery system comprising a solution comprising a biodegradable polymer, a water miscible biocompatible organic solvent, at least one pharmaceutically active agent, and optionally a release rate-limiting agent. The system is implantable that provides controlled release of the active throughout an extended drug delivery time period (copending claim 1).
The copending claims differ from the instant claims in that they do not disclose an injectable composition nor a amphiphilic or hydrophobic additive, as recited in instant claim 1.
Chen discloses injectable depot gel compositions that provide an excipient for modulating a release rate and stabilizing beneficial agents (abstract).The injectable compositions of Chen also release a beneficial agent over a prolonged duration ([0013]). The composition comprises a gel vehicle comprising a bioerodible, biocompatible polymer and a water-immiscible solvent; a beneficial agent dissolved or dispersed in the gel vehicle; and an excipient for modulating a release rate, wherein the excipient stabilizes the beneficial agent by offsetting the effects of degradation of the polymer ([0013]; claim 1). The excipient may comprise an antioxidant such as tocopherol ([0016]; [0037]; [0072]; claims 5 and 8), which reads on a hydrophobic additive.
First, regarding the recitation of “injectable” in the instant claims, such a limitation is an intended use limitation. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). Chen serves as evidence that the solution of the copending claims would have been able to be used as an injectable compositions since compositions comprising all of the same core elements (i.e., a degradable polymer, solvent, active, and release agent) are routinely used as injectable compositions in the art, as taught by Chen.
Second, it would have been prima facie obvious to one of ordinary skill in the art to incorporate the tocopherol (i.e., hydrophobic additive) of Chen in the solution of the copending claims since tocopherol is a known and routine excipient for modulating a release rate in the art as taught by Chen. One or ordinary skill in the art could have performed simple substitution of one known release-rate limiting agent for another to predictably yield the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 5, and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7 of U.S. Patent No. 12,576,035 in view of Chen. The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Chen.
The ‘035 claims recite a method comprising introducing a solution to an aqueous medium, the solution comprising a biodegradable polymer, a water miscible biocompatible organic solvent, at least one pharmaceutically active agent, and optionally (d) a release rate-limiting additive. The ‘035 claims also define a controlled release drug delivery system comprising an implantable or administered device that provides controlled release of at least one pharmaceutically active agent throughout an extended drug delivery time period, said device also comprising the solution described above.
The ‘035 claims differ from the instant claims in that they do not disclose an injectable composition nor a amphiphilic or hydrophobic additive, as recited in instant claim 1.
Chen discloses injectable depot gel compositions that provide an excipient for modulating a release rate and stabilizing beneficial agents (abstract).The injectable compositions of Chen also release a beneficial agent over a prolonged duration ([0013]). The composition comprises a gel vehicle comprising a bioerodible, biocompatible polymer and a water-immiscible solvent; a beneficial agent dissolved or dispersed in the gel vehicle; and an excipient for modulating a release rate, wherein the excipient stabilizes the beneficial agent by offsetting the effects of degradation of the polymer ([0013]; claim 1). The excipient may comprise an antioxidant such as tocopherol ([0016]; [0037]; [0072]; claims 5 and 8), which reads on a hydrophobic additive.
First, regarding the recitation of “injectable” in the instant claims, such a limitation is an intended use limitation. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997). Chen serves as evidence that the solution of the ‘035 claims would have been able to be used as an injectable compositions since compositions comprising all of the same core elements (i.e., a degradable polymer, solvent, active, and release agent) are routinely used as injectable compositions in the art, as taught by Chen.
Second, it would have been prima facie obvious to one of ordinary skill in the art to incorporate the tocopherol (i.e., hydrophobic additive) of Chen in the solution of the copending claims since tocopherol is a known and routine excipient for modulating a release rate in the art as taught by Chen. One or ordinary skill in the art could have performed simple substitution of one known release-rate limiting agent for another to predictably yield the instant invention.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue X Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/SUE X LIU/Supervisory Patent Examiner, Art Unit 1616
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