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 .
Status of the Claims
Claims 1, 5-6, and 8-21 are currently pending.
Claims 1 and 12 are amended.
Claims 13-21 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim.
Claims 2-4 and 7 are canceled.
Claim(s) 1, 5-6, and 8-12 have been considered on the merits.
Note to Applicant
In the future, it is requested that the Applicant' s follows the guidelines set forth under 37 CFR 1.121 when filing amended claim sets, see MPEP 714 section II C. Claim 1 contains the limitations “cucurbitacin” in line 11 and “chidamide” in line 15 that were not present in claim 1 filled on 05/31/2022 and markings to show the changes made to claim 1 should have been included (i.e. strike-through for deleted matter or underlining for added matter). Additionally, claim 12 is currently amended and does not contain a status identifier.
Withdrawn Rejections
The 35 U.S.C. 112(b) rejections made onto claims 1-3 and 7 are withdrawn in light of the amendments submitted on 11/17/2025.
The 35 U.S.C. 103 rejections are withdrawn in light of the amendments submitted on 11/17/2025.
New and Maintained Rejections Necessitated by Amendment
Claim Objections
Claim 1 objected to because of the following informalities:
Step b) currently reads “a ALK inhibitor” in line 9, which should be amended to “an ALK inhibitor”
Step b) currently reads “a ALK inhibitor, and and cucurbitacin” in lines 9-11, which should be amended to delete one instance of “and”.
Step c) currently reads “funny current;.” In line 17 and the period needs to be deleted.
Step d) currently reads “in a serum-free medium for to generate” in line 19 and the word “for” needs to be deleted.
Appropriate correction is required.
Claim 10 objected to because of the following informalities: a comma should be inserted after the phrase “The method of claim 1”. Appropriate correction is required.
Applicant is advised that should claim 6 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-6, and 8-12 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.
Claim 1 recites a limitation of “wherein a)-d) are performed for a period of time that is not more than 9 days”. Step d) is claimed to be “continuing to culture the SAN-like cells from step c) in a serum-free medium for to generate a population of SAN-like cells that express CAV3.1, CAV1.3, and Cx30.2”. However, the specification states “If continued in culture, (such as by 30 days), the cells express CAV3.1, CAV1.3 and Cx30.2 and electrophysiological properties similar to SA node cells” (pg. 11, [0040]). Thus, the specification supports that step d) alone requires continued culture, such as up to 30 days, to achieve the claimed cell expression profile. Therefore, the limitation of “wherein a)-d) are performed for a period of time that is not more than 9 days”, lacks written description because there does not appear to be any support for achieving the claimed cell expression profile of step d), which includes the multi-day steps a)-c), in 9 days or less.
This is a new matter rejection.
Dependent claims 5-6 and 8-12 are included in this rejection due to dependency.
Response to Arguments
Applicant’s arguments, see Remarks, pg. 7-8, filed 11/17/2025, with respect to the rejections made under 35 U.S.C. 103 have been fully considered and are persuasive. Specifically, there does not appear to be a prior art which employs chidamide in methods regarding the generation or culture of sinoatrial node cells. Accordingly, the rejection of claims 1, 5-6, and 8-12 have been withdrawn.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632