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 .
FINAL ACTION
Priority
Instant application 18/036,673 filed on 05/12/2023 claims benefit as follows:
CONTINUING DATA:
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Status of the Application
The amendment submitted on 06/27/2026 has been entered.
Claims 1 and 22 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/12/2023 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments/Amendments
The amendment filled on 06/27/2026 has been entered.
Applicant amended claim 1, canceled claims 2-21, and added claim 22.
It should be noted that Applicant limited the instant method to a method for the treatment (prevention has been deleted) of Parkinson's disease, multiple sclerosis, amyotrophic lateral sclerosis and peripheral neuropathy. In addition, Applicant limited the method to a method comprising administering SARM1 enzyme activity inhibitor as a single active ingredient to a subject in need thereof. Further, the SARM1 enzyme activity inhibitor has been limited to compounds 2-7.
Applicant’s amendment and Applicant’s arguments have overcome all rejections of record. Therefore, all rejections of records are withdrawn. However, upon further consideration, a new ground(s) of rejection is made over WO-2006/045581-A1.
The new rejection was necessitated by Applicant’s amendment.
Election/Restrictions/ Species Election
Applicant elected without traverse of compound 2 and peripheral neuropathy in the reply filed on 12/19/2025.
A careful review of the prior art has indicated that combination of elected species is free of the prior art. A claim directed to the elected species in independent form would be free of prior art.
The examiner has moved onto alternative species: compound 7
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The subsequent examination is based on this species expansion.
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO-2006/045581-A1.
WO-2006/045581 teaches instant compound 7 as PPAR ACTIVATOR (see compound 24, page 21):
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Further, WO-2006/045581 teaches and claims a method of treating multiple diseases, including Parkinson’s disease, comprising administering to a patient in need thereof a therapeutically effective amount of a compound as defined in any of claims 1-10 (see claim 17).
Therefore, WO-2006/045581 teaches the same compound for treatment of the same conditions.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a
scientific explanation for the prior art’s functioning, does not render the old composition patentably
new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947
(Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently
present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252,
1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed.
Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art
plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily
possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the
discovery of properties of a known material does not make it novel, the identification and
characterization of a prior art material also does not make it novel." Id.
Further, "where the Patent Office has reason to believe that a functional limitation asserted to
be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the characteristics relied on"); In
re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (indicating that the burden of proof can be shifted
to the applicant to show that the subject matter of the prior art does not possess the characteristic
relied on whether the rejection is based on inherency under 35 U.S.C. 102 or obviousness under 35
U.S.C. 103 (MPEP 2183).
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 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO-2006/045581-A1 in view of Paul (Paul DA, Qureshi ARM, Rana AQ. Peripheral neuropathy in Parkinson's disease. Neurol Sci. 2020 Oct;41(10):2691-2701).
WO-2006/045581 teaches instant compound 7 as PPAR ACTIVATOR (see compound 24; the last compound on page 21):
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Further, WO-2006/045581 teaches and claims a use of the compound in treatment of multiple sclerosis, Parkinson’s disease (see claim 11).
Furthermore, WO-2006/045581 teaches and claims a method of treating multiple diseases, including Parkinson’s disease, comprising administering to a patient in need thereof a therapeutically effective amount of a compound as defined in any of claims 1-10 (see claim 17).
WO-2006/045581 teaches that the compound acts as a PPAR activator but does not teach the compound acts as a SARM1 enzyme activity inhibitor as recited in instant claims.
However, WO-2006/045581 teaches the same compound for treatment of the same conditions. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252,1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." (See also MPEP 2112)
Further, "where the Patent Office has reason to believe that a functional limitation asserted to
be critical for establishing novelty in the claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to require the applicant to prove that the
subject matter shown to be in the prior art does not possess the characteristics relied on"); In
re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980) (indicating that the burden of proof can be shifted
to the applicant to show that the subject matter of the prior art does not possess the characteristic
relied on whether the rejection is based on inherency under 35 U.S.C. 102 or obviousness under 35
U.S.C. 103 (MPEP 2183).
Regarding instant claim 22, WO-2006/045581 does not explicitly teach treatment of peripheral neuropathy.
WO-2006/045581 teaches and claims a method of treating Parkinson’s disease comprising administering to a patient in need thereof a therapeutically effective amount of the compound.
Paul teaches that peripheral neuropathy (PN) is present in Parkinson’s disease (PD) (see abstract).
Treating Parkinson’s disease inherently treats peripheral neuropathy, a result that logically flows from the administration steps disclosed by WO-2006/045581.
It is noted that MPEP 2112 discusses the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph).
Conclusion
No claim is allowed.
Applicants’ 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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, Clinton A 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.
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.
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
/I.S./Examiner, Art Unit 1621
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