DETAILED ACTION
A unity of invention restriction requirement Office action was mailed 11 March 2026 (“Office Action”).
Applicant’s reply to the Office Action was received 11 May 2026 (“Reply”).
Notice of AIA Status
The instant application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ).
If the status of the application as subject to AIA or pre-AIA is incorrect, any correction of the statutory basis (e.g., changing from AIA to pre-AIA ) for a rejection under 35 U.S.C. §§ 102 and/or 103 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.
Status of the Claims
The listing of claims filed 16 January 2024 has been examined.
Claims 1–9 are pending.
Priority
The instant application was filed 16 January 2024; is a national stage application of PCT/IN2022/050646, filed 16 July 2022, and claims priority to IN 2021 41032267, filed 17 July 2021. Applicant’s claim for foreign priority is acknowledged, and a copy of the priority document has been received.
Information Disclosure Statement
An information disclosure statement (IDS) has not been received.
Election/Restrictions
Applicant’s election with traverse of Group I (claims 1–5) in the reply filed 11 May 2026 is acknowledged. Applicant argues there would not be a serious search burden on Examiner to search for prior art for both Groups I and II. (Remarks, p.1). Applicant also argues the restriction requirement should be withdrawn because the claims have been amended. (Id.).
Applicant’s arguments have been considered but are not persuasive. This application is a national stage application of a PCT, which means establishing a search burden is not required for a restriction requirement based on a lack of unity of invention. Further, no claim amendments have been received in this application. The original claims are examined.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6–9 (Group II) are withdrawn.
Objections to the Specification
The title of the invention is objected to because it refers to the purported merits of the invention (“Novel”).
Appropriate correction is required.
For guidelines for the preparation of patent titles, see MPEP § 606 (Explaining: The word novel should not be included in the title of the invention).
Objections to the Specification
The abstract of the disclosure is objected to because it recites language referring to the purported merits (“novel”) and phrases that can be implied (“The present invention provides”).
Appropriate correction is required.
For guidelines for the preparation of patent abstracts, see MPEP § 608.01(b) (Explaining: The abstract should be in narrative form and avoid legal phraseology (e.g., means, said), terms referring to purported merits of the invention (e.g., new, novel), and phrases that can be implied (e.g., The disclosure concerns, The disclosure defined by this invention). The language should be clear and concise, and not repeat information given in the title. It should not compare the invention with the prior art. The abstract is generally limited to a single paragraph within the range of 50 to 150 words in length.).
Claim Objections
Claims 1 and 2 are objected to for using improper capitalization. Trademarks may not be improperly used in claims. (MPEP § 2173.05(u)). In this case, the capitalizations appear to be a typographical error rather than a reference to a trademark because revefenacin is a common name for a compound in branded drugs, diphenylphosphoryl is a chemical name, and sodium, potassium, rubidium, and cesium are chemical elements. The capitalization of a common name, chemical name, or element is not necessary or proper.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites: “A process for the preparation of Revefenacin . . . comprising one or more of the following steps.” Claim 1 recites six steps (a–f). With respect to the prior art, only one step in the context of preparing revefenacin needs to be found to anticipate the claim.
Claim Rejections - 35 U.S.C. § 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 WO 2006/099165 (“Theravance”).
Theravance discloses a method of preparing revefenacin. (Theravance, pp. 30–33).
In Preparation 1, biphenyl-2-isocyanate is reacted with 4-hydroxy-N-benzylpiperdine. (Id., p.30). The compound biphenyl-2-isocyanate is Formula (VI) in instant claim 1.
Preparation 1 does not state that biphenyl-2-isocyanate was made and used in situ.
Biphenyl-2-isocyanate is commercially available. See, e.g., Millipore Sigma; available at https://www.sigmaaldrich.com/US/en/product/aladdinscientific/alnh9a9dc24f (23 June 2026).
One of ordinary skill in the art would have understood Theravance to teach the compound biphenyl-2-isocyanate was obtained from a commercial source (i.e., in a pure and isolated form).
Based on the above facts, Theravance inherently discloses step “b) optionally isolating compound of formula (VI)” because it uses biphenyl-2-isocyanate in a method of preparing revefenacin, and the most reasonable inference is that the compound was obtained as a pure and isolated chemical from a commercial source.
Examiner recommends amending claim 1 to delete the phrase “one or more of the following steps” (after “comprising”).
Claim Rejections - 35 U.S.C. § 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.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claims 1–5 are rejected under 35 U.S.C. § 103 as being unpatentable over Theravance in view of Flick et al., J. Med. Chem. (2020), 63, 10652–140704 (“Flick”) and Greene et al., Protective Groups in Organic Synthesis (3rd Ed. 1999), p.503 (“Greene”).
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Regarding claims 1, 4, and 5, Theravance discloses a method of preparing revefenacin. (Theravance, pp.30–33). Theravance discloses a reaction of the compound obtained from Preparation 3 (biphenyl-2-ylcarbamic acid 1-[2-(benzylmethylamino)ethyl]piperdin-4-yl ester) with hydrogen in the presence of palladium catalyst—in ethanol—to obtain the compound of Preparation 4 (biphenyl-2-ylcarbamic acid 1-[2-(methylaminoethyl)piperdin-4-yl ester) by removing the Cbz (i.e., carbobenzyloxy or -C(O)-OBn) protecting group from the nitrogen atom. (Id., p.32). That reaction in Theravance corresponds to step e) of instant claim 1.
Flick is a review article that discusses the synthesis in Theravance. Flick summarizes the synthesis in Scheme 23, shown below. Compound 135 is reacted with compound 136 in a reductive amination reaction; and the nitrogen protecting group Cbz (i.e., carbobenzyloxy or -C(O)-OBn) is then removed by hydrogenation to obtain compound 137, which is the same compound as instant compound of Formula (VIII).
PNG
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623
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(Flick, p.10669).
Greene is a book about protecting groups used in organic synthesis. Chapter 7 is directed to protecting an amino group. Greene teaches carbamates like Boc (cleaved by acidic hydrolysis) and Cbz (cleaved by catalytic hydrogenolysis) are two of the most useful compounds for protecting a nitrogen atom. (Greene, p.503).
Ascertaining the differences between the prior art and the claims at issue
Theravance does not obtain the compound of Formula (VIII) by deprotecting the nitrogen protected with Boc in the presence of an acid. Instead, Theravance uses a different nitrogen protecting group (Cbz) than the one used in step e) of instant claim 1.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include evidence of nonobviousness relevant to step e).
The question of obviousness
Based on the above factors, it would have been prima facie obvious for a person having ordinary skill in the art prior to the filing of the instant application to modify the teachings of Theravance in view of Greene to arrive at the claimed process because Boc and Cbz are functionally equivalent nitrogen protecting groups. One of ordinary skill in the art would have had a reasonable expectation of success because the level of skill in the art is high and the Cbz and Boc protecting groups are well-known and routinely used in organic synthesis, as noted in Greene.
Claims 2 and 3 do not further limit the subject matter of step e). Those claims, if written into independent form to include the subject matter of claim 1, would be subject to this rejection.
Examiner recommends amending claim 1 to delete, “one or more of the following steps.”
Conclusion
No claims are allowed.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/J.M.N./Patent Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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