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 .
DETAILED ACTION
This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 12/16/2025.
As filed, claims 1, 3-7, and 20-22 are pending; claims 2, 8-19, and 23-26 are withdrawn; and claims 27-32 are cancelled.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 12/16/2025, with respect to claims 1, 3-7, and 20-22, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112 fourth paragraph rejection of claim 21 is withdrawn per amendments.
The § 102(a)(1) rejection of claims 1, 3-7, 20, and 22 by CAS775 is withdrawn per amendments.
The § 102(a)(1) rejection of claims 1 and 3-6 by Bessie is withdrawn per amendments.
The provisional, nonstatutory obviousness-type double patenting (ODP) rejection of claims 1, 3-6, and 22 by co-pending application no. 17/310,179 is maintained because Applicant’s remarks are not persuasive. Without filing and approval of a terminal disclaimer, the provisional ODP rejection is maintained.
The provisional, nonstatutory obviousness-type double patenting (ODP) rejection of claim 21 by co-pending application no. 17/310,179 is maintained because Applicant’s remarks are not persuasive. Without filing and approval of a terminal disclaimer, the provisional ODP rejection is maintained.
The claim objection of claim 1 is withdrawn per amendments.
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, 3-7, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Abstract Registry No. 1218817-70-9, hereinafter CAS709.
Regarding claims 1, 3-7, and 22, CAS709 teaches the following compound or pharmaceutical composition thereof (with unbuffered water), which meets all the limitations of these claims
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134
386
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42
620
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Wherein: instant variables R1 and R2 are H; instant variable V is C7-alkyl; instant variable W is a bond; instant variable X is phenyl; instant variables m is 1; instant variables R3 and R4 are H; instant variable n is 0; instant variables Y and Z are bonds; instant variables R7 and R8 are H.
Claims 1, 3-6, and 22 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2022/0089581, hereinafter Lynch. See IDS filed 3/9/2023.
Regarding claims 1, 3-6, and 22, Lynch, for instance, teaches the following compound or pharmaceutical composition thereof, which meets all the limitations of these claims.
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316
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(pg. 7,compound 5f)
Wherein: instant variables R1 and R2 are H; instant variable V is C10 alkyl; instant variable W is a bond; instant variable X is phenyl; instant variables m is 0; instant variable n is 2; instant variables Y and Z are bonds; and one of instant variable R5 and one of instant variables R7, together with the carbons and the nitrogen atom form a piperidine ring, while the remaining instant variables R5, R6, and R8 are H.
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110
430
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(paragraph 0090)
Double Patenting
The 3/9/2023 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to a compound of instant formula (I) or pharmaceutical composition thereof.
Claims 1, 3-6, and 22 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
17/310,179
19 and 20
Yes
In this instance, the analysis employed for the abovementioned nonstatutory obviousness-type double patenting rejection parallels the analysis for anticipation, wherein the instant compound is anticipated by the compound, which is
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(5e), etc., and such compounds are encompassed by the abovementioned conflicting claims of the abovementioned co-pending application.
Claim 21 is rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
17/310,179
19 and 20
Yes
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned co-pending application are drawn to an obvious variant of the compound of instant formula (I) (i.e. positional isomer), or pharmaceutical composition thereof.
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned co-pending application described the compound of instant formula (I) as a positional isomer thereof.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) 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 those 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 typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness - none
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other because they are drawn to its obvious variant having the same therapeutic utility (e.g. SPNS2 inhibitor, etc.). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned co-pending application.
As recited above, the compounds in the conflicting claims of abovementioned co-pending application are obvious variants of the compounds of instant formula (I).
As for the abovementioned obvious variants (i.e. positional isomer), MPEP 2144.09.II. states, “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195USPQ 426 (CCPA 1977).
The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds (i.e. positional isomer) would possess similar activity (i.e. they would be therapeutically active as SPNS2 inhibitors).
Accordingly, one of ordinary skill would be motivated, from the disclosure in the prior art, to make the modifications required to arrive at the instant invention with reasonable expectation of success for obtaining a compound with the same utility. The motivation to make the change would be to make additional compound for the quoted purpose.
Subsequently, the instant compounds are prima facie obvious over the abovementioned positional isomer.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown that the abovementioned positional isomer (i.e. obvious variants) are patentably distinct and therefore, excluded as the compound of instant formula (I) the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant compound forms and that of the conflicting claims of the abovementioned co-pending application to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy 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.
Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1, 3-7, 21, and 22 are rejected.
Claim 20 is objected.
Claims 2, 8-19, and 23-26 are withdrawn.
Claims 27-32 are cancelled.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton 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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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621