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 .
Election/Restrictions
Applicant’s election without traverse of Group III, claims 21-28 in the reply filed on 6/5/26 is acknowledged.
Claims 1-7,12-13, and 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/5/26.
Applicant's election with traverse of SEQ ID NO 1 in the reply filed on 6/5/26 is acknowledged. The traversal is on the ground(s) that the elected group does not require a SEQ ID. This is not found persuasive because in the event of claim amendments requiring the SEQ ID, a serious search burden would exist. See the restriction requirement mailed 4/20/26.
The requirement is still deemed proper and is therefore made FINAL.
Claims 21-28 are under examination herein.
Priority
Application claims priority to 62/477903 and 63/541314 provisional application with an effective filing date of 2/24/23 and 9/29/23. Claims of the instant application are not supported by the priority documents, specifically there is no support for the claimed generic protein comprising a Zn 2+ binding domain. Therefore, instant application has a priority date of 2/23/24.
Information Disclosure Statement
The IDS filed on 5/28/26, 5/23/24 have been fully considered except where references have been lined through.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 25, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
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 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Bai (WO 2024/092160) While Bai was published after the filing date of instant invention, it claims priority to 10/26/22 and therefore is valid prior art under 35 USC 102(a)(2). Claims 23-24 are further evidenced by Perevozchikova ("Investigating the structural impact of the glutamine repeat in huntingtin assembly." Biophysical Journal 107.2 (2014): 411-421).
Regarding claims 21, 25, and 28, Bai teaches methods and compositions of proteases (abstract). Bai teaches that the protein can comprise insulin-degrading enzyme (IDE) (p38 lines 26-31). As evidenced by instant claim 25, IDE is a protein comprising a Zn2+ binding region exhibiting antiaggregating activity. Bai teaches that the protein can be effective against protein aggregates of huntingtin (HTT) which are pathogenic (p38 lines 1-13). As evidenced by instant claim 28, HTT is an aggregation prone poly Q protein.
It is obvious to one of ordinary skill in the arts to experiment within the inventive confines of Bai to arrive at a method of using a disaggregating protein to disaggregate a aggregation prone polyQ protein. All of the claimed components were known in the arts at the time of filing of instant invention and would be yield nothing more than predictable results with a reasonable expectation of success to one of ordinary skill in the arts.
Regarding claim 22, Bai teaches that the protein can act on a substrate comprising the HTT aggregate (contacting the aggregates) (p38 lines 1-11).
Regarding claims 23-24, as evidenced by Perevozchikova, HTT in the pathogenic form comprises more than 36 glutamines in a repeat (contiguous) (introduction).
Regarding claim 26, Bai teaches the protein can be administered to a subject (in vivo) (p59 lines 10-17).
Regarding claim 27, Bai teaches that viral vectors can be used to introduce the protein into a cell (p55 lines 24-40). Bai teaches that cell can be a eukaryotic cell (conditions to allow the aggregation protein polyQ protein to be disaggregated) (claim 38).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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, Louise Humphrey can be reached at 571-272-5543. 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.
/TREVOR KANE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657
Prosecution Insights