DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/03/2026 has been entered.
Response to Amendment
The amendments received 02/03/2026 have been entered. Claims 1, 5, and 8-11 are pending. Claim 10 remains withdrawn. Any objection or rejection set forth in the Office Action mailed 09/04/2025 not maintained herein has been overcome and is withdrawn. Examiner has considered Applicant’s arguments regarding the rejection of claim 1 under 112(b) over the limitation “devoid of any stabilizer or chelating agent” and finds the arguments persuasive.
New grounds of rejection are set forth.
Election/Restrictions
Claim 1 is allowable. The restriction requirement between groups I and II, as set forth in the Office action mailed on 10/07/2024 , has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is maintained because the nonelected claims do not require all the limitations of an allowable claim.
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.
Claim 11 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 11 contains the trademark/trade name "USP". Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a name used to identify the business United States Pharmacopeia and/or monographs thereof and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites “wherein the composition comprises at least 90% of the naltrexone when stored at 40oC / 75 % RH and 25 oC / 60% RH for at least 6 months.” However, claim 1, from which claim 8 depends, is directed toward a “stable” composition. Per the instant specification, the term “stable” is defined as below (p. 10 of specification filed 01/07/2022).
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Claim 8 recites limitations that are within the definition of “stable” as in the instant specification. Moreover, while claim 1 only recites “stable” generally, in the Remarks filed 07/14/2025 on pages 5-6, Applicant argues against the rejection of the claims over “stable” being indefinite by citing the above definition. Thus, Applicant’s argument in the Remarks filed 02/03/2026 that “stable” is to be interpreted more broadly than the definition in view of the specification (p. 4-5) contradicts Applicant’s previous arguments. It is unclear, therefore, how claim 8 recites a narrower limitation than that which is inherently required by claim 1 as previously argued.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1, 5, and 9 are allowed. The closest prior art is that of record.
Conclusion
Claims 1, 5, and 9 are allowed. Claims 8 and 11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 04/16/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624