DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 06/10/2024, are acknowledged. Claims 1-7, 9, 11, 13-17, 20-26, 28-30, 40-42 and 54 are pending in this action. Claims 8, 10, 12, 18-19, 27, 31-39, 43-53 have been cancelled. Claims 2-6, 9, 11, 13-15, 17, 20-21, 26, 29-30, 40-42 have been amended. Claims 1-7, 9, 11, 13-17, 20-26, 28-30, 40-42 and 54 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 371 of PCT/US2022/072115, filed May 4, 2022, which claims benefit of provisional U.S. Application No. 63/184,760, filed May 5, 2021.
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 (96 pages, exclusive of claims, as filed 06/10/2024) 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 the term “poloxamer comprises P407” (Para. 0017, 0044, 0313, 0340) that is unclear. If the applicant implies the use of the poloxamer sold under the trade name Kolliphor® P 407 that should be clarified.
The specification comprises typographic errors (Para. 0019-0025, 0040-0043, 0046-0051, 0066, 0315-0320, 0337-0339, 0342-0347), e.g., “60-90 wt% polycaprolactone” that needs to be corrected to “60-90 wt% of polycaprolactone. Appropriate correction is required.
The specification comprises multiple acronyms without proper definitions, e.g., “DL”, “FaSSGF”, “FED”, “FaSSIF”, “LYN-014-M”, “QPI”, “HPMCAS-MG” (e.g., Para. 0033, 0034, 0060, 0077, 0081, 0083, 0127, 0141, 0156, 0166). The acronym should be given once in parenthesis after the first use of the full term, and then the acronym used alone thereafter if needed. Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown without units of measurements (e.g., Para. 0103, 0202). Appropriate correction is required.
The use of the trademarks/trade names has been noted in this application (e.g., Para. 0109, 0110, 0152, 0167, 0207, 0218, 0222-0224; examples). It should be capitalized wherever it appears and be accompanied by the generic terminology. 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 foreign applications (e.g., Para. 0112, 0134). 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).
Information Disclosure Statement
The information disclosure statement (11 pages), filed 06/10/2024, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Claim Objections
Claims 1-4, 7, 9, 11, 13-14, 28-30, 40-41, 54 are objected to because of the following informalities:
Claim 1 comprises the typographic error “35-50 wt% polycaprolactone” that needs to be corrected to “35-50 wt% of polycaprolactone”. Similar is applied to other constituents recited in claim 1, as well as to claims 2-4, 7, 9, 11, 28-30, 54.
Claim 1 comprises the typographic error “the methadone” that needs to be corrected to “methadone”. Similar is applied to claim 28.
Claim 13 comprises the typographic error “comprises 20 mg to 50 mg” that needs to be corrected to “comprises from 20 mg to 50 mg”. Similar is applied to claims 14, 40-41.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-7, 9, 11, 13-17, 20-26, 28-30, 40-42 and 54 are 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 pre-AIA the applicant regards as the invention.
Claim 1 discloses a system comprising at least one drug-eluting component comprising methadone or a salt thereof, 35-50 wt% polycaprolactone, and 0.5-3 wt% poloxamer; and a release rate-modulating film coating the at least one drug-eluting component, wherein said system is configured to release at least 10% of methadone after the first 24 hrs of residence within the stomach. First, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Second, it is noted that the numerical limitation “10%” is unclear and indefinite, because the recited release amounts are not clearly delineated (e.g., mol%, wt%, etc.) Therefore, the metes and bound of the claim are not reasonably clear. Similar is applied to claim 28. Clarification is required.
Claim 5 recites the limitation “poloxamer comprises P407” that is not reasonably clear. Does this limitation imply that a poloxamer is a mixture (i.e., comprising)? Further, it is noted that neither the claim not the instant specification provides a clear definition for the term “P407”. Therefore, the scope of the claim is unclear. Clarification is required.
Claim 6 recites the limitation “film comprises polycaprolactone, copovidone, and magnesium stearate” that is not reasonably clear. Does this limitation disclose a film composition comprising a mixture of recited compounds, OR at least one of them. Similar is applied to claim 23 regarding the limitation “segment comprising polycaprolactone, hydroxypropyl methylcellulose acetate succinate and poloxamer” as well as to claim 24. Clarification is required.
Claim 17 (dependent on claims 15 and 1) recites the limitation “comprises a drug-eluting component of the at least one drug-eluting component” that is unclear. In the present case, it is noted that independent claim 1 discloses at least one drug-elution component comprising methadone or salt thereof, but does not teach or suggest “at least one drug-elution component comprising a drug-eluting component”. Similar is applied to claim 25. Clarification is required.
Claim 21 recited the limitation “an acid terminated copolymer of DL-lactide and glycolide (50/50 molar ratio)”, wherein recited parenthetical expression does not clarify the scope of the claim. To this point, it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). This limitation was interpreted as best understood as “an acid terminated copolymer of DL-lactide and glycolide with a 50/50 molar ratio of DL-lactide/glycolide monomers”. Clarification is required.
Claim 26 (dependent on claim 1) recites the limitation “an area under the curve of the gastric residence system is between 1000 and 6000 hr-ng/mL” that is unclear. To this point, it is noted that the instant claims do not disclose any curves of the gastric residence system. Clarification is required.
Claim 54 discloses “the drug eluting component comprises 40-70 wt% of methadone or a salt thereof, 35-50 wt% of polycaprolactone, and 0.5-3 wt% of poloxamer” that is not clear, because the amount of mixing compounds (e.g., 70+35+0.5 wt%) is more than 100%. Clarification is required.
Claims 2-4, 7, 9, 11, 13-16, 20-22, 29-30, 40-42 are rejected as being dependent on rejected independent claims 1, 28 and failing to cure the defect.
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.
Claims 1-7, 9, 11, 13-17, 20-26, 28-30, 40-42 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over Kanasty et al., US 2020/0146979 A1 (cited in IDS; hereinafter referred to as Kanasty), in view of Gernot et al., US 2015/0343067 A1 (cited in IDS; hereinafter referred to as Gernot).
Kanasty teaches gastric residence systems comprising of therapeutic agents, and/or components of said gastric residence systems such as segments or elongate members of gastric residence systems, with release rate-modulating films and methods for making and using such systems (Abstract; Para. 0006, 0007). To this point, Kanasty teaches that said gastric residence system may include:
(i) at least one elongate member comprising the therapeutic agent or the pharmaceutically acceptable salt, e.g., 40-60% of methadone (Para. 0187, 0196) and a carrier polymer(s), e.g., 44-62% of polycaprolactone, 1-15 wt% of poloxamer 407 (e.g., Kolliphor P407; Para. 0013; 0014, 0185, 0558 as applied to claims 1-2, 4-5); and
(ii) release rate-modulating polymer films covering elongated members (Para. 0024, 0042 as applied to claim 1), wherein said film may include, e.g., 48-83.8% of polycaprolactone, 4.4-23.5% of copovidone, and 2 % of magnesium stearate (Para. 0032-0034, 0130, 0134, 0136-147 as applied to claim 6-7, 9, 11).
Kanasty teaches that said gastric residence systems may include 10-600 mg of therapeutic agents (Para. 0019 as applied to claim 13).
PNG
media_image1.png
279
373
media_image1.png
Greyscale
Kanasty teaches that the gastric residence system is configured to be maintained within a stomach of a human body for at least 48 hours and to release at least 10% of the therapeutic agent/methadone during 24 hr of residence time during the stomach (Para. 0171, 0214, 0216 as applied to claim 1).
Kanasty teaches that said gastric residence system (shown in the right) comprises a central elastomer (element 106 in Fig. 1A) and a plurality of arms (elements 108) comprising a proximal end (element 103) affixed to the central elastomer (element 106) and a distal end (element 102), wherein each arm of the plurality of arms extends radially from the central elastomer, and at least one arm of the plurality of arms comprises the at least one drug-eluting component (Fig. 1A, Para. 0117, 0157 as applied to claims 15-17, 54).
Kanasty teaches that said gastric residence system may include a polymer linker(s) such as polycaprolactone, hydroxypropyl methylcellulose acetate, a poloxamer (Para. 0040, 0116, 0117, 0159, 0252 as applied to claims 20, 23); (BiO)2CO3 (here as bismuth subcarbonate; Para. 0217 as applied to claim 22); copovidone (Para. 0130 as applied to claims 24, 25).
Kanasty teaches a method of making said gastric residence systems, wherein said method includes extruding the at least one elongate member comprising the therapeutic agent or the pharmaceutically acceptable salt, and coating said elongate member with release rate-modulating film (Para. 0041, 0042 as applied to claims 28-29, 40, 42).
Kanasty does not teach the use of levomethadone as a therapeutic agent (claims 3; 14, 30, 41).
Gernot teaches dosage forms providing extended and delayed release of an active agent suitable for the treatment of pains and for pain therapy, e.g., levomethadone (Abstract; Para. 0059, 0068, 0069).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use/try levomethadone as taught by Gernot in gastric residence systems comprising therapeutic agents as taught by Kanasty. One would do so with expectation of beneficial results, because Kanasty teaches drug delivery systems, which remain in the stomach for extended period of time providing sustained release of pharmaceuticals included, and allowing thereby to optimize the frequency of the drug administering. Claims 21, 26 are rejected as being dependent on rejected base claims. Applicant is advised to clarify the claim language/scope and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615