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 Claims and Response to Amendments
The amendments filed June 3, 2026 have been acknowledged and entered. Claims 1-2, 23-25 and 27-37 are pending.
Information Disclosure Statements
Acknowledgement is made of the Information Disclosure Statement filed on June 3, 2026 . All references have been considered except where marked with a strikethrough.
Election/Restriction
The present examination is based on Applicant’s election of S3QEL-2 and Alzheimer’s disease in the response filed January 20, 2026. Applicant remarks filed June 3, 2026 did not overcome the art rejection set forth in the previous office action. The search has thus been limited to the elected species.
Elected Species:
PNG
media_image1.png
221
498
media_image1.png
Greyscale
Claims 27, 31 and 35 (in full) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species. Claims 1-2, 23-25 and 28-30, 32-34 and 36-37 are withdrawn in part, other than the above indicated subgenus, with regard to prior art search as being drawn to a nonelected species.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Maintained Rejections
Claim Rejections - 35 USC § 112a
Claims 1-2, 23-25, 30 and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The reasons for this rejection were set forth in the previous Office Action mailed March 3, 2026 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed June 3, 2026 have been fully considered but they are not persuasive.
Applicant argues that the application as filed provides evidence that S1QELs
and S3QELs are biologically active in assays directly relevant to neurodegenerative diseases,
including neuroinflammation assays, astrocytic reactivity assays, and neuronal survival assays in both
in vitro cell culture systems and in vivo transgenic mouse models of frontotemporal dementia-linked
pathology (hTauP301S mice). Applicant submits that claim 1 represents a reasonable generalization of the S1QEL and S3QEL compounds tested in the specification (page labeled 12 of remarks).
This argument is not found persuasive because the claims do not require that the S1QEL or S3QEL possess any particular structure. Nor does the specification teach that such compounds correspond to any particular structure. The claims fail to comply with the written description requirement for the reasons which were set forth previously and which are incorporated herein by reference and repeated in part below.
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is.” See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.")".
The rejection is still deemed proper and thus maintained.
Claim Rejections - 35 USC § 103
Claims 1-2, 23-25 and 28-30, 32-34 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Orr et al. (Nature Chemical Biology 2015, 11, 834-836) (hereinafter “Orr”) in view of Reddy (Journal of Biomedicine and Biotechnology 2006, 6, article 31372, pages 1-13) (hereinafter “Reddy”).
The reasons for this rejection were set forth in the previous Office Action mailed March 3, 2026 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed June 3, 2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments against the references individually (arguments regarding Orr at pages labeled 13-14 “Regarding Orr”), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The instant claims are unpatentable over Orr in view of Reddy.
Applicant states they disagree with the Examiner's characterization of Reddy (page labeled 14 of remarks) and argues Reddy's teaching is not the broad principle that any reduction of ROS treats Alzheimer's disease. Reddy specifically discloses that mitochondrially targeted antioxidant scavengers represent a promising therapeutic approach. In other words, compounds that physically accumulate inside
mitochondria by exploiting the mitochondrial membrane potential and neutralize existing free radicals
may be used to treat Alzheimer's disease.
Examiner respectfully disagrees. Applicant seems to be characterizing Reddy as narrowly focused on mitochondrially targeted antioxidants (see page labeled 14 of remarks, quotation from Reddy; page 15 Reddy’s teaching is not the broad principle…); however, as a whole Reddy is teaching that antioxidants may be beneficial in the treatment of Alzheimer’s disease. Although Reddy discusses mitochondrially targeted antioxidants, a person of ordinary skill in the art would easily have recognized that the therapeutic approach to treat AD disclosed in Reddy is to reduce ROS. Reddy’s use of mitochondrially targeted antioxidants would not have precluded or discouraged the exploration of other antioxidant therapies including treating with a S3QEL as is claimed. Moreover, and as pointed out by Applicant, Reddy specifically notes that mitochondrial antioxidants have a major limitation (Reddy at page 1 cited by Applicant, a major limitation in applying mitochondrial antioxidants to AD treatment has been the inability of researchers to enhance antioxidant levels in mitochondria). Although Reddy notes there has been a breakthrough, the known limitation would have motivated a person of ordinary skill in the art to explore other antioxidant therapies such as treatment with a S3QEL.
Applicant further appears to be arguing that the instant claims are not obvious over the prior art because the antioxidants of Reddy and Orr have different antioxidant effects and mechanisms of action (see page labeled 15 of remarks, Orr expressly discloses that site-specific ROS suppression (i.e., S3QEL-2) and general ROS elimination (i.e., the antioxidants disclosed in Reddy) produce different outcomes…One of ordinary skill in the art would have understood the differences between selective ROS production suppression and indiscriminate scavenging and the concomitant biological consequences…there are substantial mechanistic difference…). These arguments are not found persuasive for the reasons noted above (as a whole Reddy is teaching that antioxidants may be beneficial in the treatment of Alzheimer’s disease. Reddy’s use of mitochondrially targeted antioxidants would not have discouraged the exploration of other antioxidant therapies including treating with a S3QEL as is claimed). The differences in the antioxidants noted by Applicant would not have precluded using a S3QEL to treat AD because as a whole Reddy teaches that antioxidants may be beneficial in the treatment of AD.
The rejection is still deemed proper and maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 KEVIN MARTIN whose telephone number is (571)270-0917. The examiner can normally be reached Monday - Friday 8 am - 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, Jeffrey Murray can be reached on (571) 272-9023. 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.
June 10, 2026
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/
Primary Examiner, Art Unit 1624
Prosecution Insights