DETAILED ACTION
Claims 1-18 are pending in the present application.
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 .
Reissue Applications
The present reissue application is a reissue of USPN 10,358,432 (the ‘432 patent). The ‘432 patent is a DIV of USPN 10,112,924, which was reissued as USPN RE 49,825.
Information Disclosure Statement
The 5 page information disclosure statement filed on February 14, 2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
In the 20 page information disclosure statement filed on February 14, 2025, foreign patents 9-35 and non-patent literature documents 40-50 have not been considered as a copy has not been provided in either the present reissue application or the underlying patent prosecution history. Additionally, non-patent literature document 17 has not been considered as the citation does not contain a title or page numbers.
Certificate of Correction
On May 9, 2023, a Certificate of Correction was issued for the ‘432 patent that amended claims 1 and 5.
As per MPEP 1410, “[p]ursuant to 37 CFR 1.173(a)(1), [reissue] applicant is required to include a copy of any disclaimer (37 CFR 1.321), certificate of correction (37 CFR 1.322 –1.324), reexamination certificate (37 CFR 1.570 and 1.997) or certificate from a trial before the Patent Trial and Appeal Board (PTAB) (37 CFR 42.80) issued in the patent for which reissue is requested. Accordingly, Applicant is required to provide a copy of the Certificate of Correction.
Non-Compliant Amendment
The amendment filed on June 20, 2024 does not comply with 37 CFR 1.173 which sets for the manner of making amendments in reissue applications. While the improper amendment has been entered and considered, a supplemental paper correctly amending the reissue application is required with Applicant’s next response. An amendment filed after final rejection that fails to comply with 37 CFR 1.173 will not be entered.
All amendment changes must be made relative to the patent to be reissued, not relative to a previous submitted amendment. Pursuant to 37 CFR 1.173(d), any such changes which are made to the specification, including the claims, must be shown by employing the following markings:
(1) The matter to be omitted by reissue must be enclosed in brackets, i.e., single brackets; and
(2) The matter to be added by reissue must be underlined.
The non-compliance issues are as follows:
In the specification, the amendment does not point to a specific column and line number for the deletion and insertion to occur. Additionally, the first line of deleted subject matter includes “35 USS.C” instead of “35 U.S.C.”.
In lines 9-10 of claim 1, the term “or methyl” is deleted by single bracketing:
PNG
media_image1.png
108
528
media_image1.png
Greyscale
However, the term “or methyl” was already deleted by the Certificate of Correction issued on May 9, 2023:
PNG
media_image2.png
24
288
media_image2.png
Greyscale
Therefore, the term “or methyl” should be absent from the present reissue claims as the term had already been deleted via a prior Certificate of Correction.
Additionally, in lines 9-10 of claim 1, the term
PNG
media_image3.png
164
96
media_image3.png
Greyscale
, which was present in issued claim 1 is missing from the current reissue claim.
In claim 5, an amendment is made to change the definition of U from “hydrogen, alkyl, or absent” to “hydrogen or alkyl”:
PNG
media_image4.png
158
554
media_image4.png
Greyscale
However, amendments to claim 5 have already been made by the Certificate of Correction issued on May 9, 2023:
PNG
media_image5.png
62
428
media_image5.png
Greyscale
The “or” between hydrogen and alkyl should not be underlined and “or absent” at the end of the claim should be omitted as these changes have already been effected via a Certificate of Correction.
Specification
The disclosure is objected to because of the following informalities: the amendment to the specification includes where Ser. No. 15/368,508 was filed Dec. 2, 201 instead of Dec. 2, 2016. Additionally, the amendment to the specification should indicate that Ser. No. 15/368,508 issued as U.S. Patent No. 10,112,924.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: In the definition of L in lines 11-13, a comma should be inserted between
PNG
media_image6.png
96
84
media_image6.png
Greyscale
and
PNG
media_image7.png
78
60
media_image7.png
Greyscale
. 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5-7, 9, and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mustazza et al. (J. Med. Chem. 2008, 1058-1062).
Mustazza et al. teaches compounds of the formula
PNG
media_image8.png
274
178
media_image8.png
Greyscale
where R1 and R2 are hydrogen, R3 is isopropyl or tert-butyl, and R4 is benzyl. See compounds 5j and 5m, Scheme 1, page 1059. With respect to claims 1 and 2, R1 and R2 together with the carbon atoms to which they are attached are aryl, R3 is unsubstituted arylalkyl, and L is (C3-C8) substituted cycloalkyl. The compounds are shown to have activity as nociceptin receptor agonists. See Table 1, page 1060. Mustazza et al. teaches that nociceptin receptor agonists are potential therapeutic agents for anxiety, neuropathic pain, cough, drug abuse, and urinary incontinence. See page 1058, first full paragraph.
Mustazza et al. does not teach where there is additional substitution on the benzyl group such that R3 is substituted arylalkyl as required by present claim 1.
In the chemical arts, compounds that differ by replacement of a hydrogen atom for a methyl group are expected to have similar properties and be obvious variants. One example is the decision on In re Wood, Whittaker, Stirling, and Ohta (199 USPQ 137). A tolyl ring (either ortho-, meta- or para-) used instead of a phenyl ring in the compound of Mustazza would create a compound with an R3 arylalkyl group substituted with a methyl group as presently claimed. Additionally, the core structure has nociceptin receptor agonist activity, and that utility would be expected to be conserved by adding a methyl group to the phenyl ring in the benzyl group.
The person of ordinary skill in the art would be motivated to modify the teachings of Mustazza et al. to arrive at the presently claimed invention as the methyl analog would be an obvious variant of the compound of Mustazza et al. Additionally, as the modifications to the compound do not affect the core structure of the pharmaceutically active compound of Mustazza et al., there would be a reasonable expectation of success.
With respect to claims 5-7, Z is
PNG
media_image9.png
46
34
media_image9.png
Greyscale
or
PNG
media_image10.png
54
28
media_image10.png
Greyscale
and U is hydrogen.
With respect to claim 9, J is -CH- and p is 0.
With respect to claims 14-18, the compounds are identified above as nociceptin receptor agonists, which are capable of treating conditions including anxiety, neuropathic pain, cough, drug abuse, and urinary incontinence. See page 1058, first full paragraph. Mustazza et al. teaches that compound 5j behaved as a full agonist. See page 1061, first column, line 13. Additionally, compound 5j was present in a pharmaceutical composition comprising an excipient to perform assays. See Figures 2 and 3, page 1059, and Table 1, page 1060. The person of ordinary skill in the art would expect that administration of compound 5j (and analogs thereof) would modulate a nociception receptor and be useful for treating or preventing substance abuse in line with the description provided by Mustazza.
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 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/370,145 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
Claim 1 of the ‘145 application claims a method of treating opioid use disorder in a patient by administering the same compounds as claimed in present reissue claims 1-18. Specifically, claims 1-13 of the ‘145 teach the same compounds as claimed in claims 1-13 of the present reissue application. Additionally, opioid use disorder includes both treating and modulating a nociception receptor and treating substance abuse and dependence as claimed in present reissue claims 15-18. Therefore, claims 1-13 and 15-18 are anticipated.
With respect to present reissue claim 14, the method of treating opioid use disorder claimed by the ‘145 application would include formulating the active agent with a pharmaceutically acceptable vehicle prior to administration in order to achieve the proper dosage. The person of ordinary skill would select appropriate vehicles depending on the form of administration and dosage required in order to appropriately administer the active agent with a reasonable expectation of success. Therefore, claim 14 is rendered obvious.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 10,358,432 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Conclusion
Claims 1-18 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
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, Patricia Engle can be reached at 571-272-6660. 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.
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/Alan Diamond/
Patent Reexamination Specialist
Central Reexamination Unit 3991
/Patricia L Engle/SPRS, Art Unit 3991