DETAILED ACTION
Status of Application
Claims 1-20, filed 12/12/2024, are pending in this action. Claims 1-20 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application is a continuation of U.S. Patent Application No. 16/411,111, filed May 13, 2019 and now issued as U.S. Patent No. 12,268,632, which claims benefit of provisional U.S. Application No. 62/670,766, filed May 12, 2018, and U.S. Application No. 62/714,383, filed August 3, 2018, 2018.
Inventorship
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.
Specification
The lengthy specification (46 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01. The specification is objected to because of the following informalities:
The specification comprises typographic errors, e.g., Latanoprost, Travoprost, Bimatoprost, PARYLENE (e.g., Para. 013-015, 087-088. 090, 094, 096-103, 106, 108) that need to be corrected to latanoprost, bimatoprost, travoprost, parylene, respectively. Appropriate correction is required.
The use of the trademarks/trade names has been noted in this application (Para. 050, 055, 070, 075, 077, 081-083, 090, 092). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The specification comprises references on a publication (e.g., Para. 056, 070). The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
The specification comprises typographic errors, e.g., anaesthetic (e.g., Para. 070), include (Para. 078) that need to be corrected to anesthetic, including, respectively. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement, filed 05/08/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Claim Objections
Claims 1, 17 are objected to because of the following informalities:
Claim 1 comprises the typographic error “and therapeutic agent” that needs to be corrected to “and a therapeutic agent”.
Claim 17 comprises the typographic error “comprising three to five depot channels” that needs to be corrected to “comprising from three to five depot channels” (see claim 16).
Appropriate correction is required.
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.
Claims1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson, US 2015/0342894 (cited in IDS), in view of Forsell, US 2006/0111791 (cited in IDS), Butuner et al., US 2015/0133546 (cited in IDS; hereinafter referred to as Butuner), and Nangia et al., US 2008/0311191 (cited in IDS; hereinafter recited as Nangia).
Anderson teaches drug delivery systems configured to exhibit zero-order or near-zero-order release of drugs, and wherein said drug delivery systems may include (Claim 1; Title; Abstract; Para. 0002, 0027, 0028):
(i) a polymeric inner matrix that may include such polymers as polysiloxanes/silicones, polyurethanes, polyisobutylene, polyisoprene, etc. (Para. 0030 as applied to claim 1);
(ii) a drug/active compound dispersed in the polymeric inner matrix, e.g., prostaglandin (Para. 0022 as applied to claims 1, 4);
(iii) a polymeric outer layer(s) disposed at least partially around the inner matrix, wherein the outer layers can be at least partially disposed around/over the inner matrix, e.g., the inner matrix may be covered by the outer layer everywhere except at one or more portions of the matrix being free of the outer layer (i.e., openings), thereby confining release of the drug to a relatively small area and, thus, allowing for extended release of the drug over extended periods of time, e.g., days, months, etc., and wherein said polymeric outer layer can be substantially impermeable to the active compounds (Claim 1; Para. 0017, 0018, 0043, 0046 as applied to claims 1, 18-20);
(iv) at least one coating disposed on an exterior surface of the polymeric outer layer (Claim 10; Para. 0027 as applied to claim 1, 10, 11).
Anderson teaches that said drug delivery systems may include upto 10 g of the drug and provide examples of the polymer matrix comprising 11.8 wt% of the active agent (Para. 0024, 084 as applied to claims 1-3).
Anderson does not teach the use of a coating layer composed of poly(p-xylylene) (claims1, 6-7, 12-13), and/or comprising a metallic material (claims 8-9, 12-14); and also does not teach the use of such prostaglandin analogs as bimatoprost, latanoprost, tafluprost, travoprost (claim 5).
Forsell teaches an implant for use inside of human body, wherein said implant comprises a base material (e.g., silicon, polyurethane) having surfaces exposed to aggressive body cells, when implanted in the human body (Abstract; Para.0009). To this point, Forsell teaches the use of cell barrier coating (e.g., comprising poly-para-xylylene polymer or titanium) that is coated on the surfaces of the base material to prevent body cells from breaking down the base material (Abstract; Para. 0007; 0022). Forsell specifically teaches the use of impermeable coating comprising poly-para-xylylene polymer (Claims 19-20; Para. 0011).
Butuner teaches sustained release delivery systems comprising a drug core, i.e., a silicone polymer matrix and a therapeutic agent, e.g., prostaglandin or analogs thereof such as latanoprost, bimatoprost, travoprost, dispersed therein (Claims 124-0128; Title; Abstract; Para. 0009-0012, 0047, 0095-0096, 0100-0102, 0139, 0195, 0199, 0211, 0267-0269), and a sheath/cover body that can be of appropriate shapes and materials to control the migration of the therapeutic agent/latanoprost from the drug core (Para. 0151-0153). Butuner teaches that latanoprost can be combined with silicone at different concentrations, e.g., 5-34% (Para. 0203).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize barrier coatings comprising poly-para-xylylene polymer or titanium as taught by Forsell preparing drug delivery systems as taught by Anderson, because Forsell teaches that said approach allows controlling/minimizing breaking down the base material in vivo. One would do so with expectation of beneficial results, because said approach would allow preventing unintended release of a drug from the polymer matrix comprising said drug and a base material. It also would have been obvious to one of ordinary skill in the art to use/try such active agents as prostaglandin analogs as taught by Butuner preparing delivery systems as taught by Anderson and Forsell. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach would provide sustained delivery systems for anti-glaucoma agents, e.g., prostaglandin analogs, providing controllable delivery of said therapeutic agents over extended period of time.
Anderson also does teach openings/depot channels that are orthogonal to the coating layers (claim 15), and/or drug delivery systems comprising depot channels (claims 16, 17).
Nangia teaches drug delivery systems (e.g., multi-layered tablets) with controllable drug release rate, e.g., providing zero order kinetics (Abstract, Para. 0109, 0110, 0115, 0123, 0179). To this point, Nangia teaches the use of drug delivery systems that include (i) an inner reservoir comprising the drug; (ii) a 1st coating layer impermeable to the passage of the drug and covering at least a portion of the inner reservoir, and wherein at least a portion of the inner reservoir is not coated with the 1st coating layer (e.g., there are one or more pores in the 1st coating layer); and (iii) a 2nd coating layer permeable to the passage of the drug, wherein the 2nd coating layer covers the 1st coating layer and the uncoated portion of the inner reservoir (Para. 0103, 0176). Nangia also teaches that one can use delivery systems/multi layers tablets including a cavity through all or part of the delivery system/tablet, wherein said cavity extends through the delivery system/tablet and creates a channel open at both ends, and wherein said delivery system/tablets can be coated on all or selected surfaces (Para. 0170).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a coating approach and/or depot channels as taught by Nanjia, preparing drug delivery systems as taught by Anderson, Forsell and Butuner. One would do so with expectation of beneficial results, because Nanjia teaches that said approach can be used for providing desired drug release profile, e.g., zero-order controlled drug release kinetics.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2018/0333296 A1 (cited in IDS) – teaches a controlled/sustained release drug delivery device/system comprising: (i) silicone matrix comprising a bioactive agent (e.g., a prostaglandin analog travoprost); and (ii) polymer coatings (that can be porous or includes openings) and/or a membrane comprising titanium, platinum, etc.; and (iii) wherein the bioactive agent is released from said system for a period of time from days to years (Para. 0008, 0023, 0132, 0138, 0145, 0399, 0412, 0414).
US 2006/0110428 (cited in IDS) - teaches a controlled/sustained release drug delivery device/system comprising: (i) a polymer matrix comprising a bioactive agent and such polymers as silicones, polyurethanes, polyesters, acrylic polymers (Para. 0097, 0249); and (ii) a coating layer on an outer surface of said polymer matrix (Para. 0136); and wherein the bioactive agent is released through small openings by pseudo zero order release kinetics (Para. 0243) for period of time from 1 month to 20 years (Para. 0243).
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,268,632.
Although the conflicting claims are not identical, they are not patentably distinct from each other because prior patent also claims: A controlled-release drug depot comprising: (a) a polymer matrix comprising a silicone polymer matrix material and a prostaglandin analogue, wherein the prostaglandin analogue is present in an amount of from 1% to 25% of the total weight of the polymer matrix material; (b) from one to five coating layers on an outer surface of the polymer matrix that form a drug impermeable membrane, the one to five coating layers having at least one coating layer comprising a poly(p-xylylene) polymer or a metallic material; and (c) from one to five depot channels, wherein each of the one to five depot channels being a tunnel that entirely traversing thorough the polymer matrix and the one to five coating layers, and each of the one to five depot channels providing a controlled release of the prostaglandin analogue; and wherein the controlled-release drug depot is a sustained-release formulation that releases the prostaglandin analogue over a period of from 7 days to 90 days. . In the present case, the instant claims are merely broader than prior patent claims that include additional limitation (i.e., prostaglandin analogues as therapeutic agent) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patent.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of copending Application No. 17/118,492.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: A drug delivery device comprising: and a polymer matrix comprising one or more drug depots having one or more therapeutic drugs, the polymer layer optionally having openings; wherein the one or more therapeutic drugs are released over period of time of at least one week and wherein the release rate approximates zero order kinetics. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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