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 .
Status of the Claims
Claims 1-20 are pending.
Claims 4, 7-8, 10-11 and 13-18 are withdrawn.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to PCT/CN2022/115068 filed on 8/26/2022 and further claims priority to FOR application numbers CN202210633028.3 and CN202110988568.9, filed 6/06/2022 and 08/26/2021, respectively. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
All references from IDS(s) received on 2/22/2024 have been considered unless marked with a strikethrough.
Elections/Restrictions
Applicant’s election of Group I without traverse in the reply filed on 7/30/2026 is acknowledged.
Claims 11 and 13-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as
being drawn to a nonelected method of use and method of making, there being no allowable generic or linking claim.
Applicant’s election of species of the Compound below elected without traverse in the reply filed on 7/30/2026 is acknowledged.
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Claims 4 (different Ring A), 7-8 (requires L1 to be -CH2-), and 10 (has additional PG group on N) are withdrawn as not reading on the elected species.
Claims 1-3, 5-6, 9, 12, and 19-20 will be examined on their merits.
No anticipatory art was found of the elected species, so the Examiner expanded the species
pursuant to MPEP 803.02. The expanded species is the sixth compound of claim 9 (see below) and reads on claims 1-3, 5-6, 9, 12, and 19-20.
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(IUPAC: 4′-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2′-(ethoxymethyl)- [1,1′-Biphenyl]-2-sulfonamide).
Anticipatory art was found on the expanded species, see 102 rejection below. Further, the elected species is rejected through an obviousness-type 103 rejection.
Claim Rejections - 35 USC § 102
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 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 1-3, 5-6, 9, 12, and 19-20 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by Murugesan, N. et al. (WO2001044239A2; cited in IDS filed 2/22/2024; “Murugesan”).
This rejection applies to the expanded species below:
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(IUPAC: 4′-[(2-butyl-4-oxo-1,3-diazaspiro[4.4]non-1-en-3-yl)methyl]-N-(4,5-dimethyl-3-isoxazolyl)-2′-(ethoxymethyl)- [1,1′-Biphenyl]-2-sulfonamide).
Murugesan teaches an overlapping genus structure with the instant claims.
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(Claim 1)
Murugesan teaches an explicit example of the expanded species (Claims 46-47) as well as a pharmaceutical composition of the compound (Claim 44).
Therefore, the limitations of claims 1-3, 5-6, 9, 12, and 19-20 are anticipated by Murugesan.
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 1-3, 5-6, 9, 12, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Murugesan, N. et al. (WO2001044239A2; cited in IDS filed 2/22/2024; “Murugesan”) in further view of Dyck et al. (J Neurochem. 1986, 46(2), 399-404; “Dyck”).
This rejection applies to the elected specie.
Murugesan teaches an overlapping genus structure with the instant claims.
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(Claim 1)
Murugesan teaches an explicit structural example with almost the same structure as the elected specie, except for the -chloro in the instant -R7 position, as well as -CD2- instead of -CH2- in the L1 position. Murugesan teaches that R3 is an isoxazolyl that is independently substituted with two substituents wither alkyl or halogen (Claims 16 and 20). Therefore, it would be obvious to substitute the -CH3 in the instant -R7 position for a halogen, such as chlorine, as taught by Murugesan.
Murugesan fails to teach deuterium substitution in the embodiments of the compounds.
However, Dyck teaches that deuterium substitution is a useful strategy to enhance the pharmacological effects of a compound without significantly altering its basic chemical structure (Page 1, left column, lines 16-19). Dyck teaches deuterium substitution can (1) protect a compound from degradation by endogenous enzymes (abstract) and (2) alter the physicochemical properties of a compound, which might affect its transport by altering its lipophilicity (page 5, right column, 2nd paragraph). Dyck suggests these large effects may be useful in developing more potent centrally acting drugs (Page 6, left column, lines 29-30).
Although Dyck does not teach the deuterated switch of the compound in the instant application,
it would have been obvious to a person skilled in the art at the time to deuterate the compound in a
position where it could avoid unwanted degradation or to enhance its physicochemical properties to
enhance drug delivery.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down inGraham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement
to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to substitute the hydrogens in structure taught by Murugesan with a deuterium switch in order to avoid unwanted endogenous degradation or to overall enhance the physicochemical properties to improve the drug metabolism or drug delivery, as taught by Dyck.
Conclusion
Claims 1-3, 5-6, 9, 12, and 19-20 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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