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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 and 22), in the reply filed on 29 June 2026, is acknowledged.
Applicants canceled claim 20 drawn to a method of Group II. However, the Restriction Requirement is not withdrawn. If applicant cancels all the claims directed to a nonelected process invention before rejoinder occurs, the examiner should not withdraw the restriction requirement. This will preserve applicant’s rights under 35 U.S.C. 121. See MPEP 821.04(b).
Current Status of 18/389,356
This Office Action is responsive to the amended claims of 29 June 2026.
Claims 1 and 22 have been examined on the merits. Claim 1 is original. Claim 22 is previously presented.
Priority
The effective filing date is 6 November 2018.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 20 January 2026 and 15 March 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
CHEN (CN 104922061 A, (September 2015), WIPO English language machine translation provided).
The prior art reference CHEN teaches a parenteral formulation for intramuscular or subcutaneous injection (page 6/10) comprising a therapeutically effective amount of nalmefene hydrochloride (the “pharmaceutically acceptable salt” of nalmefene) (page 1) and magnesium chloride (the “parenterally acceptable absorption enhancing adjuvant” of claim 1) (page 3/10). Alternatively, the limitation “parenterally acceptable absorption enhancing adjuvant” is interpreted as an inherent property/function of the claim.
Furthermore, page 6/10 of CHEN teaches that the “formulation provides a time to onset of opioid antagonistic action of less than 5 minutes post administration” to a subject experiencing an opioid agonist overdose. Alternatively, the limitation “a time to onset of opioid antagonistic action of less than 5 minutes post administration” can also be interpreted as an inherent property or function of the nalmefene hydrochloride and magnesium chloride adjuvant parenteral formulation taught by prior art reference CHEN.
When the composition recited in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed inherent. See MPEP 2112.01(I). Also, if the composition is physically the same, it must have the same properties. See MPEP 2112.01(II).
This anticipates claim 1.
Claims 1 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
REVEX (“Revex (nalmefene hydrochloride injection).” (January 2008)),
as evidenced by:
SODIUM CHLORIDE (Weleda. “Sodium chloride.” (Before 5 November 2018), Accessed 12 August 2023. Available from: < https://www.weleda.com/ingredients/sodium-chloride-90#:~:text=Sodium > ).
The reference REVEX teaches a parenteral formulation for intramuscular or subcutaneous injection comprising a therapeutically effective amount of nalmefene hydrochloride (the “pharmaceutically acceptable salt” of nalmefene) and sodium chloride (page 1).
Furthermore, the “Pharmacokinetics” section of reference REVEX teaches that the “formulation provides a time to onset of opioid antagonistic action of less than 5 minutes post administration” to a subject experiencing an opioid agonist overdose (see Table 1 on page 2). Alternatively, the limitation “a time to onset of opioid antagonistic action of less than 5 minutes post administration” can also be interpreted as an inherent property or function of the nalmefene hydrochloride and sodium chloride adjuvant parenteral formulation taught by prior art reference REVEX.
Moreover, the reference SODIUM CHLORIDE is relied upon for the beneficial teachings that sodium chloride is a known adjuvant (see page 1/2). The Examiner interprets the limitation “parenterally acceptable absorption enhancing adjuvant” of claim 1 as an inherent property/function.
When the composition recited in the prior art reference is substantially identical to that of the claims, claimed properties or functions are presumed inherent. See MPEP 2112.01(I). Also, if the composition is physically the same, it must have the same properties. See MPEP 2112.01(II). This anticipates instant claim 1.
REVEX teaches intravenous, intramuscular, and subcutaneous administration and “nalmefene hydrochloride injection” (emphasis on “injection”) (see page 1, especially title). The “injection” of page 1 infers that a needle/injection (a “drug delivery system comprising an injection device”) will be used thereby anticipating claim 22.
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 22 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,857,547 B2. The instant amended claims of 29 June 2026 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, reference claims 1 and 7, each drawn to a parenteral formulation comprising an aqueous solution of nalmefene free base or pharmaceutically acceptable salt thereof (ie., nalmefene hydrochloride) and an adjuvant, anticipates instant claim 1, drawn to same.
The instant claim 1 limitations: “therapeutically effective amount” is inherently anticipated by the reference claims since it would not be a parenteral formulation if it were not “therapeutically effective”.
Moreover, the limitation “parenterally acceptable absorption enhancing amount of an adjuvant” and “wherein the formulation provides a time to onset of opioid antagonistic action of less than 5 minutes post administration via an intramuscular or subcutaneous injection to a subject experiencing an opioid agonist overdose” each constitute inherent properties or functions. See MPEP 2112.01(I) and (II).
Reference column 18 teaches an injection device of instant claim 22.
Claims 1 and 22 are rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,865,112 B2. The instant amended claims of 29 June 2026 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, reference claim 1, drawn to a parenteral formulation comprising a therapeutically effective amount of nalmefene or pharmaceutically acceptable salt thereof and an adjuvant, wherein the formulation provides a time to onset of opioid antagonistic action of less than 5 minutes post administration via an intramuscular or subcutaneous injection to a subject experiencing an opioid agonist overdose, anticipates instant claim 1, drawn to same.
Moreover, the limitation “parenterally acceptable absorption enhancing amount of an adjuvant” constitutes an inherent property or function. See MPEP 2112.01(I) and (II).
Also, reference claim 13, drawn to a drug delivery system comprising an injection device containing a parenteral formulation of claim 1, anticipates instant claim 22, drawn to same.
Conclusion
No claims are presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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, Andrew D Kosar can be reached at (571) 272-0913. 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.
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights