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 .
Claim Status
Applicants’ amendments and arguments filed 10/21/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 1 and 4 are amended.
Claims 2-3, 5-13, 15-32, 35-40, 42-51, 53-56, 58-64, 66-67, 69-71, 73-74, 76-86, 88-115, 117-136, 140-141, 143-144, and 146-150 are cancelled.
Claims 14, 33-34, 41, 52, 57, 65, 68, 72, 75, 87, 116, and 142 remain withdrawn.
Claims 1, 4, 137-139, and 145 are examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/21/2025 is being considered by the examiner.
Claim Interpretation
As to the limitation of 'for use in a gastric residence system’ it is noted that the instant claims are composition claims and future intended use is not given patentable weight. Thus any composition comprising a carrier polymer, at least one agent or pharmaceutically acceptable salt thereof, and a release rate-modulating film coated on a least a portion of the surface of the arm wherein the release rate-modulating film comprises a combination of poly-D,L-lactide (PDL) and poly-D,L-lactide/glycolide (PDLG) will meet this limitation.
Claim 137 recites the term “substantially free of the agent.” The term “substantially” is not defined or described in the disclosure with regard to an amount of agent. As such, for the purposes of this examination, the term will be defined as a small amount greater than 0%, specifically examiner broadly interprets this to mean up to 5%.
Claim 139 recites the term “wherein the release rate of agent from the arm is substantially the same before and after thermal cycling.” The term “substantially” is not defined or described in the disclosure with regard to thermal cycling. The examiner broadly interprets substantially to be defined as +/-5%.
As to the limitations of Claim 139, applicant is reminded this is a composition/product claim and the prior art teaches a gastric arm comprising polycaprolactone, risperidone, and poly-D,L-lactide with poly-D,L-lactide/glycolide thereby since a product is not separable from its physical properties then it necessarily teaches the same release rate of agent from the arm under the conditions claimed by instant claim 139. Therefore, since the prior art teaches the composition described by applicants instant application, but applicants observation that the ‘release rate of agent from the arm in aqueous media is substantially linear over at least a 96-hour period and substantially the same before and after thermal cycling’ does not give it patentable weight, since it is the same composition as adding a characterization to a prior art patented invention is not patentable. Thus, any art teaching the limitations of the instant claim 1 with also teach the limitations of the instant claim 139.
In regards to claims 1 and 138, which utilize the term “about”. Applicants’ specification broadly defines about as “When numerical values are expressed herein using the term "about" or the term "approximately," it is understood that both the value specified, as well as values reasonably close to the value specified, are included. For example, the description "about 500 C" or "approximately 500 C" includes both the disclosure of 500 C itself, as well as values close to 500 C. Thus, the phrases "about X" or "approximately X" include a description of the value X itself. If a range is indicated, such as "approximately 500 C to 600 C" or "about 500 C to 600 C," it is understood that both the values specified by the endpoints are included, and that values close to each endpoint or both endpoints are included for each endpoint or both endpoints; that is, "approximately 500 C to 600 C" (or "about 500 C to 600 C") is equivalent to reciting both "500C to 600 C" and "approximately 500 C to approximately 600 C" (or "about 500 C to 600 C)” which fails to distinctly define the term “about”. Therefore, examiner broadly interprets “about” to mean plus or minus 10% of any number following the term.
New Rejections Necessitated by Claim Amendments
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 138 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 138 states “wherein the increase in the weight of the arm due to addition of the release rate-modulating film is about 2% to about 6% of the weight of the uncoated arm”. Claim 138 is dependent upon claim 1 which fails to claim or define the weight of the arm and fails to claim an embodiment of an uncoated arm, therefore leaving claim 138 indefinite as it is unclear what defines both elements. Therefore, for the purpose of moving prosecution forward, examiner broadly interprets the claim to mean any concentration of the release rate-modulating film.
Claim Rejections - 35 USC § 103
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 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.
Claims 1, 137-139, and 145 are rejected under 35 U.S.C. 103 as being unpatentable over Kanasty et al. (WO2018227147A1, published 12/13/2018, hereafter Kanasty) in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences) and in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). https://web.archive.org/web/20160824222556/https://www.polysciences.com/default/polydl-lactic-acid-iv-20-28dlg, via wayback machine, hereafter Polysciences2).
As cited for interest, PLGA is generally an acronym for poly D,L-lactic-co-glycolic acid (page 2, paragraph 2.1; Makadia, H.K.; Siegel, S.J. Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier. Polymers 2011, 3, 1377-1397. https://doi.org/10.3390/polym3031377).
Kanasty claims a gastric residence system comprising a therapeutically effective amount of an agent or a pharmaceutical acceptable salt thereof wherein: the gastric residence system has at least one elongate member (claim 1; according to the claim limitations of the instant claim 1). Kanasty further defines the elongated members as arms (paragraph 0157; according to the claim limitations of the instant claim 1). Claim 1 of Kanasty further claims the elongate member comprising: a carrier polymer, the agent or the pharmaceutically acceptable salt thereof, and a release-rate modulating polymer film coated on the surface (according to the claim limitations of the instant claim 1). Claim 30 Kanasty claims the carrier polymer to comprise a poly lactone and claim 31 of Kanasty further defines the carrier polymer as polycaprolactone (according to the claim limitations of the instant claim 1). Claim 2 of Kanasty claims the polymer film comprises one or more of polycaprolactone (PC ), polyglycolic acid (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), a polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyhydroxy valerate (PHV), poty(3-hydroxybuty ate-co-3-hydroxyvalerate) (PHBV), polyethylene adipate (PEA), polybutylene succinate (PBS), a polyester with one or more aromatic groups in the main chain, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PIT), polyethylene naphthalate (PEN), block or random copolymers incorporating the monomer constituents of any of the foregoing, copolymers of lactide and caprolactone (poly-lactide-co-caprolactone; PLC), cellulose acetate (CA), ethyl cellulose (EC), copolymers of acrylate and methacrylate esters, Eudragit S; or a mixture of two or more of the foregoing (according to the claim limitations of the instant claim 1). Furthermore, Kanasty teaches the film lacking permeable agent and lacking pores produced by the removal of porogens (paragraph 0038; according to the claim limitations of the instant claim 137). Additionally, Kanasty teaches the concentration of porogens within the film to be about 1-40% (paragraph 0033; according to the claim limitations of the instant claim 137). Paragraph 0035 of Kanasty claims the release-rate modulating polymer film can comprise about 0.1-20% of the total weight of the segment (according to the claim limitations of the instant claim 138). Furthermore, Kanasty teaches the weight of the film can make up about 0-10% of the film-covered carrier polymer agent segment (paragraph 0151; according to the claim limitations of the instant claim 139). Lastly, Kanasty teaches the agent/agents are to include, but are not limited to the following: drug, a pro-drug, a biologic, a statin, rosuvastatin, a nonsteroidal anti-inflammatory drug (NSAID), meloxicam, a selective serotonin reuptake inhibitor (SSRs), escitalopram, citalopram, a blood thinner, clopidogrel, a steroid, prednisone, an antipsychotic, aripiprazole, risperidone, an analgesic, buprenorphine, an opioid antagonist, naloxone, an anti-asthmatic, montelukast, an anti-dementia drug, memantine, a cardiac glycoside, digoxin, an alpha blocker, tamsulosin, a cholesterol absorption inhibitor, ezetimibe, an anti-gout treatment, colchicine, an antihistamine, loratadine, cetirizine, an opioid, loperamide, a proton-pump inhibitor, omeprazole, an antiviral agent, entecavir, an antibiotic, doxycycline, ciprofloxacin, azithromycin, an anti-malarial agent, levothyroxine, a substance abuse treatment, methadone, varenicline, a contraceptive, a stimulant, caffeine, a nutrient, folic acid, calcium, iodine, iron, zinc, thiamine, niacin, vitamin C, vitamin D, biotin, a plant extract, a phytohormone, a vitamin, a mineral, a protein, a polypeptide, a polynucleotide, a hormone, an anti-inflammatory drug, an antipyretic, an antidepressant, an antiepileptic, an antipsychotic agent, a neuroprotective agent, an anti-proliferative, an anti-cancer agent, an antimigraine drug, a prostaglandin, an antimicrobial, an antifungals, an antiparasitic, an anti-muscarinic, an anxiolytic, a bacteriostatic, an immunosuppressant agent, a sedative, a hypnotic, a bronchodilator, acardiovascular drug, an anesthetic, an anti-coagulant, an enzyme inhibitor, a corticosteroid, a dopaminergic, an electrolyte, a gastro-intestinal drug, a muscle relaxant, a parasympathomimetic, an anorectic, an anti-narcoleptics, quinine, lumefantrine, chloroquine, amodiaquine, pyrimethamine, proguanil, chlorproguanil-dapsone, a sulfonamide, sulfadoxine, sulfamethoxypyridazine, mefloquine, atovaquone, primaquine, halofantrine, doxycycline, clindamycin, artemisinin, an artemisinin derivative, artemether, dihydroartemisinin, arteether, or artesunate (paragraph 0187; according to the claim limitations of the instant claim 145). Kanasty further claims the viscosity of the release rate-modulating polymer film to be about 1.0-2.1 dL/g or more specifically 1.5-2.1dL/g (claims 16-17; according to the claim limitations of the instant claim 1).
Kanasty fails to teach the viscosity of PDL and PDLG specifically as claimed by instant claim 1.
Polysciences teaches a product of poly(D,L-lactide-co-glycolide) in which the viscosity is 0.4dL/g (description).
Polysciences2 teaches a product of poly-D,L-lactide in which the viscosity is from 1.6-2.4 dL/g (specifications).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric arm composition comprising polycaprolactone, an agent or pharmaceutical, and a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as outlined by Kanasty ready for improvement with the known technique of measuring and optimizing viscosities of poly-D,L-lactide and poly-D,L-lactide/glycolide to the known values of known products 1.6-2.4 dL/g and 0.4 dL/g respectively as outlined by Polysciences and Polysciences2. Adding the forementioned limitations to a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, both Polysciences and Polysciences2 teach values for these polymers are known to lie within the ranges of the instant claim 1 making them further of obviousness.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kanasty et al. (WO2018227147A1, published 12/13/2018, hereafter Kanasty) in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences) and in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). https://web.archive.org/web/20160824222556/https://www.polysciences.com/default/polydl-lactic-acid-iv-20-28dlg, via wayback machine, hereafter Polysciences2), and in view of Moroishi et al. (Moroishi, H., Sonotaki, S., & Murakami, Y. (2018). PLA- and PLA/PLGA-Emulsion Composite Biomaterial Sheets for the Controllable Sustained Release of Hydrophilic Compounds. Materials, 11(12), 2588. https://doi.org/10.3390/ma11122588, hereafter Moroishi).
As described above, Kanasty in view of Polyscience and in view of Polyscience2 teaches the arm composition of the instant claim 1. However, Kanasty fails to teach the ratio of poly-D,L-lactide to poly-D,L-lactide/glycolide as claimed by the instant claim 4.
Moroishi teaches a PLA/PLGA biomaterial sheet for the controllable sustained release of hydrophilic compounds (title). Furthermore, Moroishi teaches PLA and PLGA have been frequently used in the polymeric biomaterials, because of their biocompatibility and easily controllable degradation properties (page 3-4, paragraph section 3.1). Moroishi teaches the sheets are aimed to achieve successful release of drugs (page 2, paragraph 2). Lastly, Moroishi teaches PLA and PLGA together at the following concentrations: PLA = 2% and PLGA = 1-4% (page 3, paragraph section 2.2).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric arm composition comprising polycaprolactone, an agent or pharmaceutical, and a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as outlined by Kanasty ready for improvement with the known technique of measuring and optimizing the ratio of poly-D,L-lactide to poly-D,L-lactide/glycolide to the known range of 2:1 to 1:2 as outlined by Moroishi. Adjusting the concentrations of poly-D,L-lactide to poly-D,L-lactide/glycolide within a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 4 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan.
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 and 145 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 28-29, and 56-57 of U.S. Patent No. US12023406B2 in view of Burt et al. (Burt, H. M., Zhang, X., Toleikis, P., Embree, L., & Hunter, W. L. (1999). Development of copolymers of Poly(D,L-lactide) and methoxypolyethylene glycol as micellar carriers of paclitaxel. Colloids and Surfaces B: Biointerfaces, 16(1–4), 161–171. https://doi.org/10.1016/s0927-7765(99)00067-3, hereafter Burt), in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences), and in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). https://web.archive.org/web/20160824222556/https://www.polysciences.com/default/polydl-lactic-acid-iv-20-28dlg, via wayback machine, hereafter Polysciences2). Although the claims at issue are not identical, they are not patentably distinct from each other.
US12023406B2 claims a gastric residence system comprising a therapeutically effective amount of an agent or a pharmaceutically acceptable salt thereof wherein at least one elongate member (i.e. instant claimed ‘arm’) comprises a carrier polymer, the agent or the pharmaceutically acceptable salt, and a release-rate modulating polymer film coated on the surface (claim 1; according to the claim limitations of the instant claim 1). Furthermore, claim 1 of US12023406B2 claims the release-rate modulating polymer film comprises one or more polyester materials with a repeating unit of the form -R1-O-C(=O)-, wherein R1 is selected from the group consisting of C1-C12 alkylene groups, ethers containing between two and twelve carbon atoms, and polyesters containing between three and twelve carbon atoms (according to claim limitations of the instant claim 1). Claim 3 of US12023406B2 claims the release rate modulating polymer film comprises at least two different polyester materials (according to the claim limitations of the instant claim 1). Claim 28 of US12023406B2 claims the carrier polymer to be a polylactone and claim 29 of US12023406B2 claims the carrier polymer to be polycaprolactone (according to the claim limitations of the instant claim 1). Furthermore, claim 56 of US12023406B2 claims the agent or pharmaceutically salt thereof is selected from the group consisting of donepezil, doxycycline, a pharmaceutically acceptable salt of donepezil, or a pharmaceutically acceptable salt of doxycycline (according to the claim limitations of the instant claim 145). Lastly, claim 57 of US12023406B2 claims the gent or pharmaceutically salt thereof is risperidone or a pharmaceutically acceptable salt of risperidone (according to the claim limitations of the instant claim 145).
US12023406B2 fails to teach the release-rate modulating film specifically be a mixture of poly-D,L-lactide and poly-D,L-lactide/glycolide.
Burt teaches that poly-D,L-lactide and poly(lactide-co-glycolide) are polyesters (page 162, paragraph 4 and paragraph 6 respectively).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric arm or elongate comprising a carrier polymer such as caprolactone, a pharmaceutical agent such as risperidone, and a release rate modulating film coated on the surface in which the film is made of two polyesters as claimed by US12023406B2 with the simple substitution of poly-D,L-lactide and poly(lactide-co-glycolide as the two polyesters as outlined by Burt. Simple substitution of two polyesters for another is within the purview of the skilled artisan and would yield predictable results.
Both US12023406B2 and Burt fail to teach the intrinsic viscosities of PDLG and PDL as in instant claim 1.
Polysciences teaches a product of poly(D,L-lactide-co-glycolide) in which the viscosity is 0.4dL/g (description).
Polysciences2 teaches a product of poly-D,L-lactide in which the viscosity is from 1.6-2.4 dL/g (specifications).
One skilled in the art before the effective filing date of the claimed invention would gastric arm or elongate comprising a carrier polymer such as caprolactone, a pharmaceutical agent such as risperidone, and a release rate modulating film coated on the surface in which the film is made of two polyesters such as poly-D,L-lactide and poly(D,L-lactide-co-glycolide) as outlined by US12023406B2 in view of Burt ready for improvement with the known technique of measuring and optimizing viscosities of poly-D,L-lactide and poly-D,L-lactide/glycolide to the known values of known products 1.6-2.4 dL/g and 0.4 dL/g respectively as outlined by Polysciences and Polysciences2. Adding the forementioned limitations to a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, both Polysciences and Polysciences2 teach values for these polymers are known to lie within the ranges of the instant claim 1 making them further of obviousness.
Claims 1 and 145 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 13 of U.S. Patent No. US11576866B2, in view of Kanasty et al. (WO2018227147A1, published 12/13/2018, hereafter Kanasty), in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences), in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). https://web.archive.org/web/20160824222556/https://www.polysciences.com/default/polydl-lactic-acid-iv-20-28dlg, via wayback machine, hereafter Polysciences2), and as evidenced by Burt et al. (Burt, H. M., Zhang, X., Toleikis, P., Embree, L., & Hunter, W. L. (1999). Development of copolymers of Poly(D,L-lactide) and methoxypolyethylene glycol as micellar carriers of paclitaxel. Colloids and Surfaces B: Biointerfaces, 16(1–4), 161–171. https://doi.org/10.1016/s0927-7765(99)00067-3, hereafter Burt). Although the claims at issue are not identical, they are not patentably distinct from each other.
As cited for interest, PLGA is generally an acronym for poly D,L-lactic-co-glycolic acid (page 2, paragraph 2.1; Makadia, H.K.; Siegel, S.J. Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier. Polymers 2011, 3, 1377-1397. https://doi.org/10.3390/polym3031377).
Further as cited for interest, poly(lactic acid) or polylactide contains chiral entities, it exists in a few forms, most commonly poly(l-lactide), poly(d-lactide), and poly(D,L-lactide) (page 2, 2.2.2.1 Polylactide; Raja, M. M., Lim, P. Q., Wong, Y. S., Xiong, G. M., Zhang, Y., Venkatraman, S., & Huang, Y. (2019). Chapter 18: Polymeric Nanomaterials: Methods of Preparation and Characterization. In Nanocarriers for Drug Delivery (pp. 557–653). essay., via ScienceDirect)
As evidenced by Burt, poly-D,L-lactide and poly(lactide-co-glycolide) are polyesters (page 162, paragraph 4 and paragraph 6 respectively).
US11576866B2 claims a gastric residence system comprising a therapeutically effective amount of adamantane-class drug or a pharmaceutically acceptable salt thereof wherein the system comprises at least one elongate member (i.e. instant claimed ‘arm’) comprises a carrier polymer, adamantane-class drug or a pharmaceutically acceptable salt, and a release rate-modulating polymer film coated on the surface in which the release rate modulating film comprises one or more polyester materials (claim 1; according to the claim limitations of the instant claim 1). Claims 3 and 13 of US11576866B2 claims the adamantane-class drug or pharmaceutically acceptable salt thereof is selected from the group consisting of memantine, amantadine, adapromine, nitromenantine, rimantadine, bromantane, tromantadine, neramexane (according to the claim limitations of the instant claim 145).
US11576866B2 fails to teach the release-rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide.
Kanasty claims a gastric residence system comprising a therapeutically effective amount of an agent or a pharmaceutical acceptable salt thereof wherein: the gastric residence system has at least one elongate member (claim 1; according to the claim limitations of the instant claim 1). Kanasty further defines the elongated members as arms (paragraph 0157; according to the claim limitations of the instant claim 1). Claim 2 of Kanasty claims the polymer film comprises one or more of polycaprolactone (PC ), polyglycolic acid (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), a polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyhydroxy valerate (PHV), poty(3-hydroxybuty ate-co-3-hydroxyvalerate) (PHBV), polyethylene adipate (PEA), polybutylene succinate (PBS), a polyester with one or more aromatic groups in the main chain, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PIT), polyethylene naphthalate (PEN), block or random copolymers incorporating the monomer constituents of any of the foregoing, copolymers of lactide and caprolactone (poly-lactide-co-caprolactone; PLC), cellulose acetate (CA), ethyl cellulose (EC), copolymers of acrylate and methacrylate esters, Eudragit S; or a mixture of two or more of the foregoing (according to the claim limitations of the instant claim 1).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric residence system comprising a therapeutically effective amount of adamantane-class drug or a pharmaceutically acceptable salt thereof wherein the system comprises at least one elongate member comprises a carrier polymer, adamantane-class drug or a pharmaceutically acceptable salt, and a release rate-modulating polymer film coated on the surface as claimed by US11576866B2 with the simple substitution of using poly-D,L-lactide and poly-D,L-lactide/glycolide as the polymers in the release rate modulating film as outlined by Kanasty and as evidenced by Burt. Simple substitution of a group of polyesters for another group of polyesters is within the purview of the skilled artisan and would yield predictable results.
Further both US11576866B2 and Kanasty fail to teach the viscosity of PDL and PDLG specifically as claimed by instant claim 1.
Polysciences teaches a product of poly(D,L-lactide-co-glycolide) in which the viscosity is 0.4dL/g (description).
Polysciences2 teaches a product of poly-D,L-lactide in which the viscosity is from 1.6-2.4 dL/g (specifications).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric residence system comprising a therapeutically effective amount of adamantane-class drug or a pharmaceutically acceptable salt thereof wherein the system comprises at least one elongate member comprises a carrier polymer, adamantane-class drug or a pharmaceutically acceptable salt, and a release rate-modulating polymer film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide coated on the surface as claimed by US11576866B2 in view of Kanasty ready for improvement with the known technique of measuring and optimizing viscosities of poly-D,L-lactide and poly-D,L-lactide/glycolide to the known values of known products 1.6-2.4 dL/g and 0.4 dL/g respectively as outlined by Polysciences and Polysciences2. Adding the forementioned limitations to a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, both Polysciences and Polysciences2 teach values for these polymers are known to lie within the ranges of the instant claim 1 making them further of obviousness.
Claims 1, 137-139, and 145 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 40, 143-146, and 218 of copending Application No. 17774132 (reference application) in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences), and in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). https://web.archive.org/web/20160824222556/https://www.polysciences.com/default/polydl-lactic-acid-iv-20-28dlg, via wayback machine, hereafter Polysciences2). Although the claims at issue are not identical, they are not patentably distinct from each other.
17774132 claims a gastric residence system comprising one or more arms comprising a carrier polymer and an agent (claim 1; according to the claim limitations of the instant claim 1). Claim 1 of 17774132 further claims the arm comprising a carrier polymer-agent further comprises a release rate-modulating film coated on the arm, wherein the release modulating film comprises poly-D, L-lactide (PDL) and poly-D,L-lactide/glycolide (PDLG) (according to the claim limitations of the instant claim 1). 17774132 claims the carrier polymer to be polycaprolactone (PCL) (claim 40; according to the claim limitations of the instant claim 1). Claim 143 of 17774132 claims the release rate-modulating film is substantially free of porogen (according to the claim limitations of instant claim 137). Claim 144 of 17774132 claims the increase in the weight of the arm due to addition of the release rate-modulation film is about 2% to about 6% of the weight of the uncoated arm (according to the claim limitations of the instant claim 138). Claim 145 of 17774132 claims the release rate of agent from the arm in aqueous media is substantially linear over at least a 96-hour period (according to the claim limitation of the instant claim 139). Claim 146 of 17774132 claims the release rate of agent from the arm is substantially the same before and after thermal cycling (according to the claim limitations of the instant claim 139). Lastly, claim 218 of 17774132 claims the at least one agent or a pharmaceutically acceptable salt thereof comprises one or more of drug, a pro-drug, a biologic, a statin, rosuvastatin, a nonsteroidal anti-inflammatory drug (NSAID), meloxicam, a selective serotonin reuptake inhibitor (SSRs), escitalopram, citalopram, a blood thinner, clopidogrel, a steroid, prednisone, an antipsychotic, aripiprazole, risperidone, an analgesic, buprenorphine, an opioid antagonist, naloxone, an anti-asthmatic, montelukast, an anti-dementia drug, memantine, a cardiac glycoside, digoxin, an alpha blocker, tamsulosin, a cholesterol absorption inhibitor, ezetimibe, an anti-gout treatment, colchicine, an antihistamine, loratadine, cetirizine, an opioid, loperamide, a proton-pump inhibitor, omeprazole, an antiviral agent, entecavir, an antibiotic, doxycycline, ciprofloxacin, azithromycin, an anti-malarial agent, levothyroxine, a substance abuse treatment, methadone, varenicline, a contraceptive, a stimulant, caffeine, a nutrient, folic acid, calcium, iodine, iron, zinc, thiamine, niacin, vitamin C, vitamin D, biotin, a plant extract, a phytohormone, a vitamin, a mineral, a protein, a polypeptide, a polynucleotide, a hormone, an anti-inflammatory drug, an antipyretic, an antidepressant, an antiepileptic, an antipsychotic agent, a neuroprotective agent, an anti-proliferative, an anti-cancer agent, an antimigraine drug, a prostaglandin, an antimicrobial, an antifungals, an antiparasitic, an anti-muscarinic, an anxiolytic, a bacteriostatic, an immunosuppressant agent, a sedative, a hypnotic, a bronchodilator, a cardiovascular drug, an anesthetic, an anti-coagulant, an enzyme inhibitor, a corticosteroid, a dopaminergic, an electrolyte, a gastro-intestinal drug, a muscle relaxant, a parasympathomimetic, an anorectic, an anti-narcoleptics, quinine, lumefantrine, chloroquine, amodiaquine, pyrimethamine, proguanil, chlorproguanil-dapsone, a sulfonamide, sulfadoxine, sulfamethoxypyridazine, mefloquine, atovaquone, primaquine, halofantrine, doxycycline, clindamycin, artemisinin, an artemisinin derivative, artemether, dihydroartemisinin, arteether, or artesunate (according to the claim limitations of the instant claim 145). Lastly, claim 147 of 17774132 claims the gastric residence system comprises an arm (according to the claim limitations of the instant claim 1).
17774132 fails to claim the PDLG and PDL intrinsic viscosity as in instant claim 1.
Polysciences teaches a product of poly(D,L-lactide-co-glycolide) in which the viscosity is 0.4dL/g (description).
Polysciences2 teaches a product of poly-D,L-lactide in which the viscosity is from 1.6-2.4 dL/g (specifications).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric residence system comprising one or more arms comprising a carrier polymer and an agent, with a release modulating film comprises poly-D, L-lactide (PDL) and poly-D,L-lactide/glycolide (PDLG) as claimed by 17774132 ready for improvement with the known technique of measuring and optimizing viscosities of poly-D,L-lactide and poly-D,L-lactide/glycolide to the known values of known products 1.6-2.4 dL/g and 0.4 dL/g respectively as outlined by Polysciences and Polysciences2. Adding the forementioned limitations to a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, both Polysciences and Polysciences2 teach values for these polymers are known to lie within the ranges of the instant claim 1 making them further of obviousness. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 145 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 15 of copending Application No. 18289326 (reference application) in view of Kanasty et al. (WO2018227147A1, published 12/13/2018, hereafter Kanasty), in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences), and in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). https://web.archive.org/web/20160824222556/https://www.polysciences.com/default/polydl-lactic-acid-iv-20-28dlg, via wayback machine, hereafter Polysciences2). Although the claims at issue are not identical, they are not patentably distinct from each other.
As cited for interest, PLGA is generally an acronym for poly D,L-lactic-co-glycolic acid (page 2, paragraph 2.1; Makadia, H.K.; Siegel, S.J. Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier. Polymers 2011, 3, 1377-1397. https://doi.org/10.3390/polym3031377).
Further as cited for interest, poly(lactic acid) or polylactide contains chiral entities, it exists in a few forms, most commonly poly(l-lactide), poly(d-lactide), and poly(D,L-lactide) (page 2, 2.2.2.1 Polylactide; Raja, M. M., Lim, P. Q., Wong, Y. S., Xiong, G. M., Zhang, Y., Venkatraman, S., & Huang, Y. (2019). Chapter 18: Polymeric Nanomaterials: Methods of Preparation and Characterization. In Nanocarriers for Drug Delivery (pp. 557–653). essay., via ScienceDirect)
18289326 claims a gastric residence system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50% polycaprolactone, and a release rate-modulating film coating (claim 1; according to the claim limitations of the instant claims 1 and 145). Furthermore, claim 15 of 18289326 claims the gastric residence system comprises a plurality of arms, in which one of the arms comprises the at least one drug-eluting component (according to the claim limitations of the instant claim 1).
18289326 fails to claim the release rate-modulating film to comprise poly-D,L-lactide and poly-D,L-lactide/glycolide.
Kanasty claims a gastric residence system comprising a therapeutically effective amount of an agent or a pharmaceutical acceptable salt thereof wherein: the gastric residence system has at least one elongate member (claim 1; according to the claim limitations of the instant claim 1). Kanasty further defines the elongated members as arms (paragraph 0157; according to the claim limitations of the instant claim 1). Claim 2 of Kanasty claims the polymer film comprises one or more of polycaprolactone (PC ), polyglycolic acid (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), a polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyhydroxy valerate (PHV), poty(3-hydroxybuty ate-co-3-hydroxyvalerate) (PHBV), polyethylene adipate (PEA), polybutylene succinate (PBS), a polyester with one or more aromatic groups in the main chain, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PIT), polyethylene naphthalate (PEN), block or random copolymers incorporating the monomer constituents of any of the foregoing, copolymers of lactide and caprolactone (poly-lactide-co-caprolactone; PLC), cellulose acetate (CA), ethyl cellulose (EC), copolymers of acrylate and methacrylate esters, Eudragit S; or a mixture of two or more of the foregoing (according to the claim limitations of the instant claim 1).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric residence system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50% polycaprolactone, and a release rate-modulating film coating as claimed by 18289326 with the ready for improvement with the known technique of using a combination of poly-D,L-lactide and poly-D,L-lactide/glycolide as outlined by Kanasty. Using a combination of poly-D,L-lactide and poly-D,L-lactide/glycolide as a release rate-modulating film as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Both 18289326 and Kanasty fail to teach the viscosity of poly-D,L-lactide and poly-D,L-lactide/glycolide as in instant claim 1.
Polysciences teaches a product of poly(D,L-lactide-co-glycolide) in which the viscosity is 0.4dL/g (description).
Polysciences2 teaches a product of poly-D,L-lactide in which the viscosity is from 1.6-2.4 dL/g (specifications).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a gastric residence system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50% polycaprolactone, and a release rate-modulating film coating comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by 18289326 in view of Kanasty ready for improvement with the known technique of measuring and optimizing viscosities of poly-D,L-lactide and poly-D,L-lactide/glycolide to the known values of known products 1.6-2.4 dL/g and 0.4 dL/g respectively as outlined by Polysciences and Polysciences2. Adding the forementioned limitations to a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, both Polysciences and Polysciences2 teach values for these polymers are known to lie within the ranges of the instant claim 1 making them further of obviousness. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 145 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10, 31, 51, 82, and 90 of copending Application No. 18272786 (reference application) in view of Kanasty et al. (WO2018227147A1, published 12/13/2018, hereafter Kanasty), in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences), and in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). https://web.archive.org/web/20160824222556/https://www.polysciences.com/default/polydl-lactic-acid-iv-20-28dlg, via wayback machine, hereafter Polysciences2). Although the claims at issue are not identical, they are not patentably distinct from each other.
As cited for interest, PLGA is generally an acronym for poly D,L-lactic-co-glycolic acid (page 2, paragraph 2.1; Makadia, H.K.; Siegel, S.J. Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier. Polymers 2011, 3, 1377-1397. https://doi.org/10.3390/polym3031377).
Further as cited for interest, poly(lactic acid) or polylactide contains chiral entities, it exists in a few forms, most commonly poly(l-lactide), poly(d-lactide), and poly(D,L-lactide) (page 2, 2.2.2.1 Polylactide; Raja, M. M., Lim, P. Q., Wong, Y. S., Xiong, G. M., Zhang, Y., Venkatraman, S., & Huang, Y. (2019). Chapter 18: Polymeric Nanomaterials: Methods of Preparation and Characterization. In Nanocarriers for Drug Delivery (pp. 557–653). essay., via ScienceDirect)
18272786 claims a gastric residence system comprising 6 arms wherein at least one arm comprises a drug eluting segment comprising a carrier polymer, risperidone or a salt thereof, and further comprising a coating comprising a release rate-modulating film (claims 1-2, 10, 31, 82, and 90; according to the claim limitations of the instant claims 1 and 145). Claim 51 of 18272786 claims the drug eluting segment comprises risperidone and polycaprolactone (according to the claim limitations of the instant claims 1 and 145).
18272786 fails to claim the release rate-modulating film to comprise poly-D,L-lactide and poly-D,L-lactide/glycolide.
Kanasty claims a gastric residence system comprising a therapeutically effective amount of an agent or a pharmaceutical acceptable salt thereof wherein: the gastric residence system has at least one elongate member (claim 1; according to the claim limitations of the instant claim 1). Kanasty further defines the elongated members as arms (paragraph 0157; according to the claim limitations of the instant claim 1). Claim 2 of Kanasty claims the polymer film comprises one or more of polycaprolactone (PC ), polyglycolic acid (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), a polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyhydroxy valerate (PHV), poty(3-hydroxybuty ate-co-3-hydroxyvalerate) (PHBV), polyethylene adipate (PEA), polybutylene succinate (PBS), a polyester with one or more aromatic groups in the main chain, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PIT), polyethylene naphthalate (PEN), block or random copolymers incorporating the monomer constituents of any of the foregoing, copolymers of lactide and caprolactone (poly-lactide-co-caprolactone; PLC), cellulose acetate (CA), ethyl cellulose (EC), copolymers of acrylate and methacrylate esters, Eudragit S; or a mixture of two or more of the foregoing (according to the claim limitations of the instant claim 1).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric residence system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50% polycaprolactone, and a release rate-modulating film coating as claimed by 18272786 with the ready for improvement with the known technique of using a combination of poly-D,L-lactide and poly-D,L-lactide/glycolide as outlined by Kanasty. Using a combination of poly-D,L-lactide and poly-D,L-lactide/glycolide as a release rate-modulating film as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Both 18272786 and Kanasty fail to teach the viscosity of poly-D,L-lactide and poly-D,L-lactide/glycolide as in instant claim 1.
Polysciences teaches a product of poly(D,L-lactide-co-glycolide) in which the viscosity is 0.4dL/g (description).
Polysciences2 teaches a product of poly-D,L-lactide in which the viscosity is from 1.6-2.4 dL/g (specifications).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim would claim a gastric residence system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50% polycaprolactone, and a release rate-modulating film coating comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by 18272786 in view of Kanasty ready for improvement with the known technique of measuring and optimizing viscosities of poly-D,L-lactide and poly-D,L-lactide/glycolide to the known values of known products 1.6-2.4 dL/g and 0.4 dL/g respectively as outlined by Polysciences and Polysciences2. Adding the forementioned limitations to a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, both Polysciences and Polysciences2 teach values for these polymers are known to lie within the ranges of the instant claim 1 making them further of obviousness. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 and 145 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 12, 15, 19, 36, 63-64, and 97 of copending Application No. 18289331 (reference application) in view of Kanasty et al. (WO2018227147A1, published 12/13/2018, hereafter Kanasty), in view of Polysciences (Poly(D,L-Lactide-co-glycolide), 50:50, IV 0.40 DL/G, acid-terminated. Poly(D,L-lactide-co-glycolide), 50:50, IV 0.40 dl/g, acid-terminated. (2017, May 29). https://web.archive.org/web/20170529103446/https://www.polysciences.com/default/poly-d-l-lactide-co-glycolide-50-50-iv-0-40-dl-g, via wayback machine, hereafter Polysciences), and in view of Polysciences (Poly(D,L-lactic acid), IV 2.0 DL/G. Poly(dl-lactic acid) i.v. 2.0 -2.8dl/g | Polysciences, Inc. (2016, August 24). Although the claims at issue are not identical, they are not patentably distinct from each other.
As cited for interest, PLGA is generally an acronym for poly D,L-lactic-co-glycolic acid (page 2, paragraph 2.1; Makadia, H.K.; Siegel, S.J. Poly Lactic-co-Glycolic Acid (PLGA) as Biodegradable Controlled Drug Delivery Carrier. Polymers 2011, 3, 1377-1397. https://doi.org/10.3390/polym3031377).
Further as cited for interest, poly(lactic acid) or polylactide contains chiral entities, it exists in a few forms, most commonly poly(l-lactide), poly(d-lactide), and poly(D,L-lactide) (page 2, 2.2.2.1 Polylactide; Raja, M. M., Lim, P. Q., Wong, Y. S., Xiong, G. M., Zhang, Y., Venkatraman, S., & Huang, Y. (2019). Chapter 18: Polymeric Nanomaterials: Methods of Preparation and Characterization. In Nanocarriers for Drug Delivery (pp. 557–653). essay., via ScienceDirect).
18289331 claims a gastric residence system comprising at least one co-extruded drug-eluting component comprising a carrier polymer, buprenorphine or a salt thereof, naloxone or a salt thereof, and a rate-modulating release film coating (claims 1, 36, 63-64, and 97; according to the claim limitations of the instant claims 1 and 145). Claim 5 of 18272786 claims that at least one co-extruded drug-eluting component comprises a first co-extruded portion comprising naloxone and a second co-extruded portion comprising buprenorphine and naloxone (according to the claim limitations of the instant claim 1 and 145). Claims 12 and 15 of 18272786 claims the composition comprises polycaprolactone (according to the claim limitations of the instant claim 1). Lastly, claim 19 of 18289331 claims the gastric residence system comprises a plurality of arms, wherein at least one arm of the plurality of arms comprises at least one co-extruded drug-eluting component (according to the claim limitations of the instant claim 1).
18289331 fails to claim the release rate-modulating film to comprise poly-D,L-lactide and poly-D,L-lactide/glycolide.
Kanasty claims a gastric residence system comprising a therapeutically effective amount of an agent or a pharmaceutical acceptable salt thereof wherein: the gastric residence system has at least one elongate member (claim 1; according to the claim limitations of the instant claim 1). Kanasty further defines the elongated members as arms (paragraph 0157; according to the claim limitations of the instant claim 1). Claim 2 of Kanasty claims the polymer film comprises one or more of polycaprolactone (PC ), polyglycolic acid (PGA), polylactic acid (PLA), poly(lactic-co-glycolic acid) (PLGA), a polyhydroxyalkanoate (PHA), polyhydroxybutyrate (PHB), polyhydroxy valerate (PHV), poty(3-hydroxybuty ate-co-3-hydroxyvalerate) (PHBV), polyethylene adipate (PEA), polybutylene succinate (PBS), a polyester with one or more aromatic groups in the main chain, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polytrimethylene terephthalate (PIT), polyethylene naphthalate (PEN), block or random copolymers incorporating the monomer constituents of any of the foregoing, copolymers of lactide and caprolactone (poly-lactide-co-caprolactone; PLC), cellulose acetate (CA), ethyl cellulose (EC), copolymers of acrylate and methacrylate esters, Eudragit S; or a mixture of two or more of the foregoing (according to the claim limitations of the instant claim 1).
One skilled in the art before the effective filing date of the claimed invention would claim a gastric residence system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50% polycaprolactone, and a release rate-modulating film coating as claimed by 18289331 with the ready for improvement with the known technique of using a combination of poly-D,L-lactide and poly-D,L-lactide/glycolide as outlined by Kanasty. Using a combination of poly-D,L-lactide and poly-D,L-lactide/glycolide as a release rate-modulating film as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Both 18289331 and Kanasty fail to teach the viscosity of poly-D,L-lactide and poly-D,L-lactide/glycolide as in instant claim 1.
Polysciences teaches a product of poly(D,L-lactide-co-glycolide) in which the viscosity is 0.4dL/g (description).
Polysciences2 teaches a product of poly-D,L-lactide in which the viscosity is from 1.6-2.4 dL/g (specifications).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim would claim a gastric residence system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50% polycaprolactone, and a release rate-modulating film coating comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by 18289331 in view of Kanasty ready for improvement with the known technique of measuring and optimizing viscosities of poly-D,L-lactide and poly-D,L-lactide/glycolide to the known values of known products 1.6-2.4 dL/g and 0.4 dL/g respectively as outlined by Polysciences and Polysciences2. Adding the forementioned limitations to a gastric arm composition comprising a release rate modulating film comprising poly-D,L-lactide and poly-D,L-lactide/glycolide as claimed by instant claim 1 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, both Polysciences and Polysciences2 teach values for these polymers are known to lie within the ranges of the instant claim 1 making them further of obviousness. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Arguments
Applicant’s arguments filed on 10/21/2025 have been considered by the examiner.
In regards to the 35 USC § 112(b) rejection over claim 138, Applicant argues the arm will inherently have a weight both before and after coating thus claim 138 does not lack antecedent basis for weight. Applicant references MPEP 2173.05(e), specifically “Inherent components of elements recited have antecedent basis in the recitation of the elements themselves.”
In response to Applicant’s argument, examiner directs the Applicant to MPEP 2173.05(e) which further states “if the scope of the claim can be reasonably assertable”. Although the arm inherently possesses a weight, it is unclear what that weight because it is not defined in the instant claim 1. For example, the uncoated arm could weigh as little as 5µg or as high as 5kg, therefore the scope of the claim cannot be reasonably asserted. Applicant’s amendments have not remedied this deficiency.
In summary, the examiner is not persuaded by Applicant’s arguments or amendments, therefore, the 35 USC § 112(b) rejection over claim 138 is maintained.
In regards to the Double Patenting rejections, Applicant states that allowable subject matter has not yet been indicated in this application and that Applicant will address these double-patenting rejections once allowable subject matter is identified.
Applicant has failed to properly address the double patenting rejections and has failed to provided any reasoning why the rejections should be withdrawn. Therefore, the examiner is not persuaded by Applicant’s arguments, thus the rejections are maintained and updated for claim amendments.
In regards to the 35 USC §103 rejection over claim 2 (now amended claim 1) over Kanasty in view of Polyscience, and in view of Polyscience2, Applicant argues that Kanasty discloses 19 polymers to include a mixture or two more and argues that this would result in 342 different combinations, thus further selections are required to choose PDL and PDLG as in the instantly claimed invention. Applicant further argues the instant application demonstrates unexpected and favorable results referencing figures 2-6 and 10-12 and examples 12-14 from the instant specification. Specifically Applicant argues that exposure to welding of the arms coated with PDL-PDLG (Fig. 10-12) films did not significantly alter the release rate of the drug from the arms and claims the opposite is true for polycaprolactone (Fig.2-6).
In response to applicant's arguments against the references individually, specifically Kanasty, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further in regards to Applicant’s argument that Kanasty teaches a variety of combinations, the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” Simply stating that Kanasty provides a list of polymers to include the instantly claimed polymer combination instead of claiming the combination solely does not demonstrate material change. In regards to Applicants reference to polycaprolactone versus PDL-PDLG, it is first noted that Applicant only handpicked a few examples from the instant application to demonstrate polycaprolactone coatings have a change in release rate upon welding. Further, Figures 7, 8A, and 8B found in the instant application correspond to PC26 (examples 9-10, page 59-61, instant specification) which is a polycaprolactone (PCL) based coating. These figures demonstrate that polycaprolactone does possess the same property of little to no change in release rate upon coating and welding. Therefore, the mixture of PDL-PDLG does not possess unexpected or superior results when compared to polycaprolactone.
In summary, the examiner is not persuaded by Applicant’s arguments against the 35 USC §103 rejection over claim 2 (now amended claim 1). Therefore, the rejection is maintained and updated for claim amendments.
In regards to the 35 USC §103 rejection over claim 4, Applicant argues that for the same reasons as above, claim 4 is not obvious.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, as outlined above, Applicant’s arguments against Kanasty in view of Polyscience, and in view of Polyscience2 are not found persuasive by the examiner. As Applicant has provided no additional reasoning for the withdrawal of 35 USC §103 rejection over claim 4, the examiner is not persuaded by Applicant’s arguments. Therefore, the 35 USC §103 rejection over claim 4 is maintained and updated for claim amendments.
Conclusion
No claims allowed.
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.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./ Examiner, Art Unit 1611