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 January 17, 2026 has been reviewed by the examiner and entered of record in the file. Claims 1 and 14 are amended. Claims 10, 11 and 15-16 are canceled. Claim 17 is newly added.
3. Claims 1, 14 and 17 are under examination and are the subject of this office action.
Previous Claim Rejections - 35 USC § 112(b)
4. 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.
5. Claims 1 and 14 remain rejected and claim 17 is newly 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.
This rejection has been modified as a result of Applicant’s amendment to the claims.
6. Claims 1 and 14, as amended, and claim 17 each recite the limitation "wherein the Epac1 protein is involved" in the preamble, however there is insufficient antecedent basis for this limitation in the claims because it is not clear from the claims themselves how the Epac1 protein is “involved” in the cardiac diseases cardiac hypertrophy, cardiac fibrosis, cardiac arrythmias and reperfusion injury, or if Epac1 is necessarily present in each of said diseases. In the Specification, Applicant discusses Epac protein expression:
“By "a disease wherein the Epac protein is involved" is meant a disease wherein
the Epac protein is expressed or over-expressed, and/or mutated.” (Specification at page 6).
In the Specification, Applicant discusses Epac inhibitors:
“An aim of the present invention is to provide novel Epac inhibitors which can be useful for the prevention and/or the treatment of inflammation, cancer, vascular diseases, kidney diseases, cognitive disorders, pain, infections, obesity, and cardiac diseases.” (Specification at page 2).
And, in the Specification at pages 3-4, Applicant discusses Epac1 inhibitors:
“In one embodiment, the compounds of formula (1) are Epac1 inhibitors. In
another embodiment, the compounds of formula (1) are Epac1 selective inhibitors. In one embodiment, Epac1 selective inhibitors are compounds which exhibit an inhibitory effect on the Epac1 isoform. More particularly, they generally exhibit an inhibitory effect on Epac1 and moderate or no inhibitory effect on Epac2 isoform. By "selective Epac1 inhibitor" it may be understood the ability of the Epac1 inhibitors to affect the particular Epac1 isoform, in preference to the other isoform Epac2. The Epac1 selective inhibitors may have the ability to discriminate between the two Epac isoforms, and so affect essentially the Epac1 isoform.”
7. Claim 14 was previously rejected as being indefinite regarding the limitation(s)
"comprising a compound having formula (II) as defined in claim 1," and “in association with at least one pharmaceutically acceptable excipient”. In view of Applicant’s amendment to incorporate the compound of formula 1 into the claim, and to clarify the components of the pharmaceutical composition, the previous indefiniteness rejection is withdrawn.
Response to Arguments
8. Applicant has amended claims 1 and 14 to specify that the Epac inhibitor is Epac1, however, it is noted that the “[A]” component of the previous 35 USC 112(b) rejection has not been addressed, i.e., Applicant has still not clarified how the Epac1 protein is “involved” in each of the recited cardiac diseases, or if Epac1 is necessarily present in each of said diseases.
9. It is suggested that claims 1, 14 and 17 be amended as follows:
“a method for treating/ preventing a cardiac disease selected from the group consisting of: cardiac hypertrophy, cardiac fibrosis, cardiac arrythmias, and reperfusion injury in a patient in need thereof, wherein said cardiac disease overexpresses the Epac1 protein, said method comprising administering to the patient a therapeutically effective amount of… [language omitted]”.
Previous Claim Rejections - 35 USC § 112(a)
10. Claims 1, 10, 11, and 14-16 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as lacking enablement for a method of treating or preventing the full scope of cardiac diseases recited comprising administering any/ all of the compound species embraced by the genus of formula (II) OR for prevention of cardiac hypertrophy and cardiac fibrosis.
11. In view of Applicant’s amendment to limit the recited method of treatment to a method of treating a cardiac disease selected from the group consisting of: cardiac hypertrophy, cardiac fibrosis, cardiac arrythmias, and reperfusion injury, comprising administering the single compound AM-001, and the recited prevention to a method of preventing reperfusion injury comprising administering the compound AM-001, the previous enablement rejection of claims 1, 10, 11, and 14-16 is withdrawn.
Applicant demonstrates the protective effect of compound AM-001 against ischemia-reperfusion injury in the Specification at Example 5, wherein “acute injection of AM-001 is efficient to prevent myocardial reperfusion injury.” (page 27, lines 24-26).
12. Claims 1 and 14 were previously 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.
13. In view of Applicant’s amendment to limit the recited method of treatment to a method of treating a cardiac disease selected from the group consisting of: cardiac hypertrophy, cardiac fibrosis, cardiac arrythmias, and reperfusion injury, wherein the method is limited to administering the single compound AM-001, the previous written description rejection is withdrawn.
Conclusion
14. Claims 1, 14 and 17 are pending in the application, and all claims are rejected. No claim is presently allowed.
15. 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.
16. 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 571-272-13101310. 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
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