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 .
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.
Current Status of 18/210,992
This Office Action is responsive to the amended claims received 17 December 2025.
Claims 1, 3, 5-15, and 19-22 are currently pending.
Election/Restrictions
Applicant’s election without traverse of ALS in the telephone conversation of 12 September 2025, as the species of “neuron inflammation condition” of claim 1, is acknowledged. The elected species has been determined to read on claims 1, 3, 9-15, and 19-21. Claims 5-8 and 22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
A search for Applicant’s elected species did not retrieve applicable prior art or double patent art. Therefore, the search was expanded sufficiently to reach the references upon which the rejections below are based. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987).
Priority
Applicant’s claim for the benefit of the prior-filed patent applications 17/323,514 (filed 18 May 2021), 16/328,956 (filed 27 February 2019), PCT/US2017/049702 (filed 31 August 2017), and 62/382,192 (filed 31 August 2016) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) received on 17 December 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this information disclosure statement is being considered by the examiner.
Response to Amendments
The objections to the drawings, present in the previous office action, are hereby withdrawn due to the replacement drawing sheets.
The objections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
The 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections are provided herein, as necessitated by Applicant’s amendments.
The 35 U.S.C. 103 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections are provided herein, as necessitated by Applicant’s amendments.
The nonstatutory double patenting rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
Response to Arguments
Applicant argues that MOUSSY does not teach one of the instantly claimed compounds. Applicant argues that the ‘648 patent, cited within a double patenting rejection in the previous action, does not teach the subject matter of the amended claims.
The Examiner has withdrawn the rejections based upon MOUSSY and the ‘648 patent due to Applicant’s 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, 9-11, 14-15, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
ELMALEH (Cited by Applicant in IDS of 9 November 2023; WO 2014/066318 A1; International Publication Date 1 May 2014).
ELMALEH teaches the compound shown below in Table 2 therein (referred to as TS734 therein). The TS734 compound of ELMALEH is identical to compound (I) of the instant claims. ELMALEH teaches TS734 to be a cromolyn derivative in paragraph [00190] therein. Together, claims 1 and 18 of ELMALEH teach the administration of a cromolyn derivate for the treatment of dementia.
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The Examiner interprets “a condition associated with prion disease”, as stated in instant claim 1, to include dementia. A definition of this phrase is not present in the instant specification.
Paragraphs [00123]-[00125] of ELMALEH teach intravenous and transdermal administration, and administration through inhalation, of the compositions therein. Together, paragraphs [0030], [0059], and claim 7 of ELMALEH teaches the additional administration of siRNA to target Aβ peptide. Paragraph [00190] of ELMALEH teaches that TS734 inhibits aggregation of Aβ.
Claim Rejections - 35 USC § 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.
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, 9-15, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over:
ELMALEH (Cited by Applicant in IDS of 9 November 2023; WO 2014/066318 A1; International Publication Date 1 May 2014).
Teachings of ELMALEH are described in the rejections above.
Regarding claims 12-13: Example 1 of ELMALEH teaches a cromolyn dosage of 20 mg taken 4 times per day (80 mg/day/patient). It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to apply the dosage taught for cromolyn (within ELMALEH) to the cromolyn derivative taught by ELMALEH, TS734. The artisan would have expected success using this dosage because the TS734 derivative is nearly identical to cromolyn.
Allowable Subject Matter
Claims 3 and 19-20 are 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.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is that of ELMALEH (Cited by Applicant in IDS of 9 November 2023; WO 2014/066318 A1; International Publication Date 1 May 2014), which teaches an identical compound. Specifically, ELMALEH teaches the compound shown below in Table 2 therein (referred to as TS734 therein), shown below. Together, claims 1 and 18 of ELMALEH teach the administration of a cromolyn derivate for the treatment of dementia.
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ELMALEH does not provide any teachings related to the condition of ALS. The Examiner is not aware of a reasonable explanation why one of ordinary skill in the art would take the compound of ELMALEH and apply it to the treatment of ALS.
Conclusion
Claims 1, 9-15, and 21 are currently rejected. Claims 3 and 19-20 are objected to as being dependent upon a rejected base claim.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 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, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625