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 .
Benefit of Earlier Filing Date
The instant application, filed 16 May 2024, is a continuation of PCT/US2022/050065, filed 16 November 2026, which claims the benefit of an earlier filing date to U.S. Provisional Patent Application Serial No. 63/281,140, filed 19 November 2021. Acknowledgment is made of Applicant’s claim.
Restriction/Election
Requirement for Restriction/Election was mailed 03 June 2026.
Applicant’s Response to Requirement for Restriction/Election was received 03 August 2026.
Applicant’s election with traverse of Group I (Claims 1-22 and 34) and the compound 1-[[2-(difluoromethoxy)pyridine-4-yl]methyl]-3-[3-hydroxyspiro[3,3]heptan-2-yl]urea, shown below, indicating claims 1-2, 6-8, 11, 21-30, and 37 read on the elected species, in the Response filed 03 August 2026 is acknowledged.
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Regarding the restriction requirement, the traversal is on the grounds that no adequate reasons and/or examples have been provided to support a conclusion of patentable distinctness between Groups I and II, with Applicant stating nothing is on the record to support the assertion that the product of Group I could be used in a materially different process of using that product.
This is not found persuasive because MPEP 806.05(h) states, “The burden is on the examiner to provide an example, but the example need not be documented. If the applicant either proves or provides a convincing argument that the alternative use suggested by the examiner cannot be accomplished, the burden is on the examiner to support a viable alternative use or withdraw the requirement.” In the Restriction/Election of 03 June 2026, the example provided was the instantly recited compounds of formula (I) could be used in a materially different process from the therapeutic and/or prophylactic treatment of a disorder, disease, or disability associated with Kv7.2, said materially different process being physiochemical biological tests. Examiner is unaware of any evidence which would suggest the instantly claimed compounds cannot be used in physiochemical biological tests.
Accordingly, the claims in Group II (Claims 23-30 and 36) and claims which do not read on the elected species (Claims 3, 10, 12-20, and 31-36) are withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable.
Status of the Claims
The listing of claims filed 03 August 2026 has been examined.
Claims 1-2, 6-8, 11, 21-30, and 37 are pending.
Claims 1, 21-23, and 30 are amended.
Claim 37 is newly added.
Claims 23-30 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species.
Claims 3-5, 9-10, 12-20, and 31-36 are cancelled.
Claims 1-2, 6-8, 11, 21-22, and 37 are examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites, “…wherein R6 is selected from a group consisting of…” The phrase “selected from a group consisting of” designates a Markush group, which is a closed group (MPEP 2117(I)). However, claim 1 also suggests the spirocyclic cycloalkyl or 7-11 membered oxo-spiro-heterocycloalkyl of R6 may be, “...optionally substituted with one, two, or three substituents independently selected from halogen, C1-6 alkyl, hydroxy, and hydroxyC1-6alkyl…” This contradicts the aforementioned Markush group. For clarity, Examiner suggests claim 1 be amended to indicate the instantly recited structures for R6 may be substituted or unsubstituted. For example, “…and
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, each which may be optionally substituted with…” [Emphasis added.] or similar according to Applicant’s intention and as supported by the disclosure.
Appropriate correction is requested.
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 1 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation, “…R6 is a 7-11 membered spirocyclic cycloalkyl or 7-11 membered oxo-spiro-heterocycloalkyl optionally substituted with one, two or three substituents independently selected from halogen, C1-6alkyl, hydroxy, and hydroxyC1-6alkyl…”, and the claim also recites, “…wherein R6 is selected from a group consisting of:
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…”, which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 37 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 37, which depends on claim 1, recites Compound 30 (i.e., 1-[[2-(difluoromethoxy)pyridine-4-yl]methyl]-3-(1-oxaspiro[4,5]decan-3-yl)urea), shown below:
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Wherein R6 is
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. However,
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is not one of the eight potential groups for R6 recited by claim 1. Thus, claim 37 improperly broadens the scope of claim 1 to include compounds wherein R6 is
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.
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS RN: 2262926-77-0 (Entered STN: 31 January 2019).
Regarding claims 1-2 and 6, CAS RN 2262926-77-0 teaches the following compound:
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Wherein R1 is haloC1-6alkoxy, R2 is H, R3 is H, R4 is H, R5 is H, n is 1, and R6 is
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.
Regarding claim 21, a compound, which, meeting all the structural limitations required by claim 1, would be expected to exhibit the same pharmacodynamic properties as recited in claim 21. Claim 21 recites, “The compound of formula (I), or a solvate or a pharmaceutically acceptable salt thereof, according to claim 1, wherein such compound shows a Kv7.2 EC50: <3 µM.” EC50 is a pharmacodynamic property. An identical compound must inherently have the same pharmacodynamic effect, even if not recognized in the art. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical compound or chemical composition and its properties are inseparable. Therefore, if the prior art teaches the claimed chemical structure, the properties Applicant discloses and/or claims are necessarily present. See MPEP § 2112.01. Consequently, CAS RN: 2262926-77-0 would inherently fulfill the limitations regarding parameters of pharmacodynamic properties recited by claim 21.
Allowable Subject Matter
Claims 8, 11, 22, and 37 contain allowable subject matter. None of the prior art of record nor a search in the pertinent art area teaches a compound of formula (I) having the additional limitations recited by dependent claims 8, 11, 22, and 37.
The following is a statement of reasons for the indicated of allowable subject matter:
The closest prior art is Bezencon (WO 2021/219594 A1). Shown below is an exemplary compound disclosed by Bezencon (p. 113, Line 6), which shares some structural similarities to the instantly claimed compounds, as well as the generic structure presented by Bezencon (p. 4, Lines 2-4):
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A structurally similar compound which is instantly disclosed is Compound 25 (Claim 37, p. 8), shown below:
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The instantly claimed compounds differ from Bezencon in the following respects:
In the instantly claimed compounds, the spirocyclic ring system has a hydroxyl substitution. Bezencon states, “Y represents -C(RY1)(RY2)-… RY1 represents hydrogen or fluoro; RY2 represents hydrogen of fluoro…” (p. 105, Lines 14-17). Thus, the substitution on the spirocyclic ring system suggested by Bezencon is fluoro, not hydroxyl, and the substitution is in a different position than it is in the instantly claimed compounds. Bezencon lacks a suggestion to make a substitution at the position corresponding to the hydroxyl group on the spirocyclic ring system in the instantly claimed compounds.
Thus, while Bezencon’s compound shares some structural similarities with the instantly claimed compounds having a structure of formula (I), a skilled artisan would not have been motivated to make the aforementioned changes as a while to the structures which would have resulted in compounds having a structure of formula (I).
Conclusion
Claims 1-2, 6, 21, and 37 are rejected.
Claims 8, 11, and 22 are objected to as being dependent upon a rejected base claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANNA L BAUER whose telephone number is (571)272-5752. The examiner can normally be reached 8am-5pm.
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, ADAM C MILLIGAN can be reached at (571)270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.L.B./Examiner, Art Unit 1623
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621
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