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 . Claims 1, 3-18 and 20 are pending in this application.
Response to Amendment
Applicant’s amendment filed 09/10/2026 in response to the previous Office Action (06/12/2026) is acknowledged. Rejection of claims 1-20 under 35 U.S.C. 102(a)(1) (item 4) and 35 U.S.C. 112(b) (items 6a-6f) has been obviated. The 35 U.S.C. 112(d) rejection (item 8) has been maintained. Even though applicants overcome most of the rejections raised in the previous Office Action by claim amendment, said amendment raises new issue that needs further rejection.
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.
Claims 15 and 20 are 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:
a. In claim 15, the phrase “treating a disease or disorder associated with dysregulated caspase activity” is indefinite. What diseases are covered and what are not? How can one tell if a given disease is not associated with dysregulated caspase activity? In order to overcome this rejection, the examiner recommends that applicants recite specific diseases.
b. Claim 20 is rejected because the pharmaceutical composition lacks a pharmaceutically acceptable carrier. Note that applicants deleted the phrase “pharmaceutically acceptable vehicle” in claim 20. It is recommended that applicants amend the claim as “A pharmaceutical composition comprising any one of the compounds, according to claim 1 and a pharmaceutically acceptable vehicle”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14 and 16-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. In claims 14 and 16-18, applicant’s recitation “wherein the compound of Formula I has an inhibitory activity against caspase 1, caspase 3 and caspase 7”, “wherein the compound of Formula I has an inhibitory activity against one or more caspase enzyme”, etc. fails to narrow down the claim limitation of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to arguments
Applicant’s argument filed 09/10/2026 has been fully considered but it is not persuasive.
Applicant’s amendment to claims 14, and 16-18 did not resolve the issue. Applicants repeated the same problem by amending the claims that did not narrow down the claim limitation of claim 1. For example, claim 14 is amended as “wherein the compound of Formula I has an inhibitory activity against caspase 1, caspase 3 and caspase 7” but said amendment fails to narrow the claim limitation of claim 1. Note that claim 1 is drawn to compounds and not to compounds with an inhibitory activity against caspase 1, caspase 3 and caspase 7. Note that applicants are simply labeling the compound as “compounds with an inhibitory activity against caspase 1, caspase 3 and caspase 7” that has no support in claim 1. Claims 14 and 16-18 are duplicates of claim 1. It is recommended that applicants delete claims 14 and 16-18 to overcome this rejection.
Allowable Subject Matter
Claims 1 and 3-13 are allowed.
Information Disclosure Statement
8. Applicant’s Information Disclosure Statement, filed on 09/10/2026 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
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 extension fee 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 date of this final action.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 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 an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Kahsay Habte/
Primary Examiner, Art Unit 1624
September 19, 2026
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