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 .
This application is a domestic application, filed 11 Oct 2023; and claims benefit of provisional application 63/415,438, filed 12 Oct 2022.
Claims 23-24 are pending in the current application and are examined on the merits herein.
Specification
The abstract of the disclosure is objected to because in chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Correction is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Chamberlain et al. (US 6,617,315, issued 09 Sep 2003, provided by Applicant in IDS filed 20 Aug 2025) in view of Verma (Synlett, 2012, 23, p1099-1100, provided by Applicant in IDS filed 20 Aug 2025).
Chamberlain et al. teaches benzimidazole derivatives and the preparation of the benzimidazole derivatives and pharmaceutical formulations containing them (abstract; column 1, lines 10-15). Benzimidazole compounds of formula (V)
PNG
media_image1.png
100
130
media_image1.png
Greyscale
are prepared by reacting a compound of formula (VI)
PNG
media_image2.png
82
116
media_image2.png
Greyscale
with a reagent such as an isothiocyanate of formula (VII)
PNG
media_image3.png
46
162
media_image3.png
Greyscale
carried out in the presence of a carbodiimide such as dicyclohexyl carbodiimide (column 14, lines 10-35). Chamberlain et al. teaches the working example including general procedures to produce 5,6-dichloro-2-(isopropylamino)-1-(2,3,5-tri-O-acetyl-beta-L-ribofuranosyl)-1H-benzimidazole including the deprotection of the compound (example 24 at column 27, line 15 to column 28, line 25), to give the compound named maribavir and addressing limitations of claim 24. In the general procedure I the appropriate 1,2-phenylenediamine is combined with the appropriate isothiocyanate (1.0–1.25 mmol/mmol of diamine) and anhydrous pyridine (3-5 mL/mmol of diamine) (column 27, lines 40-50). In the general procedure II the appropriate 2-(alkylamino)-1H-benzimidazole was reacted with 1,2,3,5-tetra-O-acetyl-L-ribofuranose, (column 27, line 55 to column 28, line 10).
Chamberlain et al. does not specifically disclose the method comprising reacting the appropriate 4,5-dichloro-1,2-phenylenediamine with diisopropylcarbodiimide (compound 6) and the appropriate isothiocyanate. (claim 23-24)
Verma teaches N,N′-diisopropylcarbodiimide (DIC) is a liquid carbodiimide used in peptide synthesis and contains the functional group RN=C=NR. By using DIC one can avoid the tedious removal of dicyclohexylurea (DCU) formed during the use of dicyclohexylcarbodiimide (DCC), as diisopropylurea (DIU) is comparatively easy to remove at the time of purification. Besides being a less expensive and commercially available reagent, DIC is a good coupling agent and widely used in solid-phase peptide synthesis. As a liquid, it is easier to handle than the commonly used DCC. In synthetic organic chemistry, compounds containing the carbodiimide functionality are dehydrating agents and are often used to activate carboxylic acids towards amide or ester formation (page 1099, section Introduction).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Chamberlain et al. in view of Verma in order to select the carbodiimide to be N,N′-diisopropylcarbodiimide. One of ordinary skill in the art would have been motivated to combine Chamberlain et al. in view of Verma in order to select the carbodiimide to be N,N′-diisopropylcarbodiimide with a reasonable expectation of success because both Chamberlain et al. and Verma teach the carbodiimide is an art-recognized class of reactant known for the same purpose, Chamberlain et al. teaches the use of a carbodiimide such as, but not limited to, dicyclohexyl carbodiimide, and Verma teaches diisopropyl carbodiimide has known advantages when used in place of dicyclohexyl carbodiimide, providing motivation for selecting the carbodiimide to be diisopropyl carbodiimide.
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 23-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 12,377,078 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-26 are drawn to the method of preparing compound 2 comprising reacting compound 5 with compounds 6 and 7, having the same structures as the claimed compounds. Reference claim 14 recites the method further comprising reacting compound 2 with compound 8 to provide compound 3, and reacting compound 3 to provide maribavir, where compounds 2 and 3 have the same structures as the claimed compounds, meeting limitations of claims 23-24. Reference claims 2-13 and 15-26 recite further limitations of the method that would fall within the scope of claims 23-24.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan S Lau whose telephone number is (571)270-3531. The examiner can normally be reached Monday-Friday 9a-5p Eastern.
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, Scarlett Goon can be reached at (571)270-5241. 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.
/JONATHAN S LAU/Primary Examiner, Art Unit 1693