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 .
Application Status
2. Applicant's amendment and response, submitted on June 17, 2026, has been reviewed by the examiner and entered of record in the file. Claims 1, 28 and 31 are amended. Claims 6, 25, 26, 29, 30, and 32 are canceled. Claims 34-39 are newly added.
3. Claims 1-3, 5, 7, 10-15, 21, 22, 27, 28, 31 and 33-39 are present in the application and under examination in this office action.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on June 17, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Previous Claim Rejections - 35 USC § 112(b)
5. 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.
6. Claims 1-3, 5-7, 10-15, 21, 22, 25-29, and 30-33 were previously 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.
7. Claims 6, 25, 26, 29, 30, and 32 are canceled.
8. Claim 1 was previously rejected as being unclear regarding the “further related statins” recited in the right column of the table. In view of the deletion of the table from the claim, and the amendment to limit the compound to atorvastatin, simvastatin, rosuvastatin, or a salt thereof, the previous indefiniteness rejection is withdrawn.
9. The rejections to claims 2, 3, 5, 7, 10-15, 21, 22, 27, 28, 31 and 33 as being dependent upon and including all of the limitations of claim 1, are also withdrawn.
10. Claim 6 was previously rejected as being unclear regarding the statins listed in the right column of the table. In view of the cancellation of claim 6, the previous indefiniteness rejection is withdrawn.
11. Claim 26 was previously rejected as being unclear regarding the statins listed in the right column of the table. In view of the cancellation of claim 26, the previous indefiniteness rejection is withdrawn.
12. Claim 29 was previously rejected as being indefinite regarding the recitation of “discomfort in other areas of the body.” In view of the cancellation of claim 29, the previous indefiniteness rejection is withdrawn.
Maintained Claim Rejections - 35 USC § 112(b)
13. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
14. Claims 28 and 31 remain 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.
15. Claim 28 was previously rejected as being unclear regarding the recitation of the “recognition of the onset of a symptom.” Applicant has amended the claim to delete “recognition of” and to limit the symptom(s) of ischemia.
However, there is insufficient antecedent basis for the limitation of “the onset of a symptom… [language omitted]” because there is no prior mention of “the onset” in the claim or in claim 1.
Therefore claim 28 remains rejected.
16. Claim 31 was previously rejected as being unclear regarding the limitation of diagnosing ischemia “by assessing a marker of ischemia.” Applicant amended the claim to add the text “the concentration of” following the term “assessing” and to clarify the method of assessing and the marker of ischemia.
However, there is insufficient antecedent basis for the limitation of “the concentration of a marker… [language omitted]” because there is no prior mention of “the concentration of” in the claim or in claim 1.
Therefore claim 31 remains rejected.
Previous Claim Rejections - 35 USC § 112(a)
17. Claims 1-3, 5-7, 10-15, 21, 22 and 25-33 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as being enabled for a method of administering atorvastatin or simvastatin to a subject in need thereof for mitigating ischemic damage due to an ischemia caused by myocardial infarction wherein the ischemia is produced in the heart, but lacking enablement for a method of preventing or reducing any/ all types of ischemia damage wherein the ischemia is produced in any tissue or organ selected from kidney, intestines, pancreas, liver, lung, skeletal muscle, and combinations thereof, as presently recited.
18. In view of Applicant’s amendment to limit the claims to the treatment of ischemia-related cardiac damage in a subject comprising administering atorvastatin, simvastatin, or rosuvastatin, wherein the ischemia is due to a myocardial infarction, the previous scope of enablement rejection is withdrawn.
19. Applicant submitted a 1.132 Declaration on June 17, 2026, and a clearer version of Figure 1 of said Declaration was submitted August 26, 2026, demonstrating the protective cardiac effects of atorvastatin or rosuvastatin on myocardial infarction following ischemia injury.
Conclusion
20. In conclusion, claims 1-3, 5-7, 10-15, 21, 22, and 25-33 are pending in the application, and all claims are currently rejected. No claim is presently allowed.
21. 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.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached on Monday-Friday 8:30AM-5PM EST.
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, Amy Clark can be reached on 571-272-0130. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
