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 .
Election/Restrictions
Election/Restrictions
Applicant’s election without traverse of Group II claims 1-15 in the reply filed on 03/30/2026 is acknowledged.
Claims 16, 20, 21, 23, 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2026.
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.
Claims 1-15 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.
The term ‘about’ renders the amount of the active ingredient(s) vague rendering the scope of the base claim 1 vague.
According to disclosure the term “about” encompasses insubstantial variations, such as values within a standard margin of error of measurement (e.g., SEM) of a stated value. Unless otherwise apparent from the context, the term “about” encompasses values within ±5% or ±10% of a stated value.
Applicants definition was considered but renders the amount(s) unclear. Consider for example, dependent claim 2. The indicated % such as
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--overlap so much the meaning of the ranges is unclear.
The term ‘by weight’ adds to the confusion, as it is unclear what this means.
In addition,
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would include 0% cholesterol by weight based on instant specification para [0058], entry 1, Table 1 at page 17.
Further with the open-ended ‘comprising’ language such ranges are confusing.
The examiner points out the use of the term "comprising" in the instant Markush groupings causes the claims to be completely open-ended when, as stated above, a Markush grouping is "by its nature" a closed grouping of alternatives. Dependent claim 3 reads,
-The subcutaneous biodegradable medical implant of claim 1, configured to release a dosage amount of naltrexone in an amount in a range of 150mg to 5 grams into a bloodstream of the patient-
What makes the specific amount(s) released and how it unclear. For example, whether this relates to the amount of cholesterol with anywhere from ~0.0 % to 9.5% is not clear. Claims 2-15 do not resolve the ambiguity of the base claim 1. As such all claims are rejected.
The open-ended comprising language renders the base claim and the dependent claims vague and indefinite. See “Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005). Note that although the claims are interpreted in light of the specification,
limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Also see, In re Zletz, 13 USPQ2d 1320,1322. “An essential purpose of patent examination is to fashion claims that are precise, clear, correct and unambiguous.”
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Felix, US20190099364, Gooberman US6203813, Misra, Journal of Pharmacy and Pharmacology (1978), 30(5), 325-6 and Emanuel, US10105443.
As per disclosure,
Naltrexone is a prescription drug belonging to a class of drugs called opioid antagonists and that the Applicant has identified a number of deficiencies associated with conventional administering of naltrexone, various solutions to which are described with respect to several embodiments described herein. A subcutaneous biodegradable medical implant comprising naltrexone and less than about 10% cholesterol by weight, wherein the subcutaneous biodegradable medical implant is capable of releasing a dosage amount of the naltrexone from the subcutaneous biodegradable medical implant following subcutaneous placement of the subcutaneous biodegradable medical implant in a patient.
Felix teaches the biodegradable medical implant comprising naltrexone and capable of releasing the naltrexone from the subcutaneous biodegradable medical implant following the placement of the subcutaneous biodegradable medical implant in the patient.
Gooberman, teaches an opiate antagonist implant which is an admixture of an opiate antagonist, in either acid or base form, and a pharmaceutically acceptable carrier. The admixture is uniformly compressed into a subcutaneously implantable pellet which is effective to release levels of the opiate antagonist over desired amounts of time when subcutaneously implanted in a patient to effectively inhibit the effects of a number of addictive drugs.
Limitations of with respect to release(d) dose of naltrexone into blood stream (of instant claim 3-7 is found at Felix page 1 column B and Tables [0077], and Felix claims.
Similarly, limitations with respect to the use of triamcinolone acetonide and magnesium stearate (of claims 5-10) in the naltrexone (the opioid antagonist) is taught by Gooberman throughout and in Gooberman claims.
Neither Felix nor Gooberman teach the use of cholesterol in combination with naltrexone in biodegradable medical implant.
The teachings of Misra and Emanuel are invoked to cure the deficiency of Felix and Gooberman, that is for the teaching, suggestion and motivation to use cholesterol in combination with naltrexone in specific amounts.
Misra teaches subcutaneous implantation of a pellet containing naltrexone (10 mg), cholesterol, and glyceryl tristearate into the dorsal area behind the right hind limb of male Wistar rats produced a complete and effective blockade of analgesia due to morphine (10 mg/kg, subcutaneous) for 1 month. See Misra at column B, page 326: The method thus has the merits of simplicity, non-toxicity, non. irritability, small size for ease of insertion and removal bio-absorbability, absence of encapsulation by surrounding tissue and an extended period of drug release un-affected by body metabolism. Pellets comprising naltrexone (30 mg), cholesterol (105 mg) and glyceryltristearate (15 mg), diameter 4·5 mm, length 9 mm, implanted subcutaneously in rats blocked the antinociceptive action of 10 mg kg-1 subcutaneous dose of morphine for 2-3 months.
Further Emanuel teaches Sustained-release Drug Carrier Composition containing cholesterol in biodegradable implants. See Emanuel claims 1, 6 and 12 and paragraph [102] for triamcinolone acetonide and magnesium salts (of fatty acids).
Therefore, with the teachings of Misra and Emanuel in front, one of skill in the art would have reasonable expectation of success in using cholesterol with naltrexone, in medical implants of Felix nor Gooberman. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges (to release of the naltrexone active ingredient) only routine skill in the art. The differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art.
Accordingly, the claims do not recite an unobvious distinction over the prior art. Further, a reference is relevant not only for what it expressly teaches, but also for what it would have conveyed to one of ordinary skill in the art. See In re Opprecht, 12 USPQ2d 1235, 1236 (Fed. Cir. 1989); In re Bode, 193 USPQ 12 (CCPA 1976). In light of the foregoing discussion, the Examiner finds that the claimed subject matter as a whole would have been obvious to one of ordinary skill in the art at the time the invention was made, in view of the cited references and the knowledge generally available in the art. Accordingly, the claims are rejected under 35 U.S.C. § 103.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625
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