DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This Office Action is in response to the paper filed 17 June 2025. Claims 1, 2, 5-7, 9, 10, 12, 16, 35, 37 have been amended. Claims 42-44, 51, 52, 56-58, 65, and 66 have been cancelled. Claims 76-78 are newly added. Claims 1-3, 5-7, 9, 10, 12, 15, 16, 35, 37, 39, and 76-78 are currently pending and under examination.
This application is a 35 U.S.C. §371 national stage filing of International Application No. PCT/US2020/048080, filed August 27, 2020, which claims benefit of priority to U.S. Provisional Application No. 62/892,712, filed August 28, 2019.
Withdrawal of Rejections:
The rejection of claims 1-3, 5-7, 9, 10, 12, 15, 16, 35, 37, and 39 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, is withdrawn.
The rejection of claim 35 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form, is withdrawn.
The rejection of claims 1-3, 5-7, 9, 10, 12, 15, 16, 35, 37, and 39 under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Edelberg et al., is withdrawn.
New Rejections Necessitated by Amendment:
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 1-3, 5-7, 9, 10, 12, 15, 16, 35, 37, 39, and 76-78 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.
To determine if a claim limitation complies with the written description requirement under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, determinations should include the following considerations:
a. Actual reduction to practice
b. Disclosure of drawings or structural chemical formulas
c. Sufficient relevant identifying characteristics, such as:
i. Complete structure
ii. Partial structure
iii. Physical and/or chemical properties
iv. Functional characteristics when coupled with a known or disclosed correlation between function and structure
d. Method of making the claimed invention
e. Level of skill and knowledge in the art
f. Predictability in the art
Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species of the invention is sufficient (MPEP 2163).
With regard to independent claims 1, 6, and 9, Applicant is deemed to have had possession of a method for treating a vascular disease, increasing blood flow in pulmonary arteries, and reducing blood pressure in a subject in need thereof, by administering hemogenic endothelial cells (HEs) obtained by in vitro differentiation of pluripotent stem cells, the HEs being positive for all of miRNA-214, miRNA-199A-3p, and miRNA-335. However, at the time of filing, Applicant is not deemed to have had possession of the methods including just one or more of the miRNA species as currently claimed. Applicant has reduced to practice the methods of treatment in a subject by administering the HEs having all of miRNA-214, miRNA-199A-3p, and miRNA-335, which Applicant calls “J1-HEs” (see Example 5, Table 5; Example 7). However, Applicant has not reduced to practice a method of providing treatment as claimed in a subject by administering HEs having only one or two of the claimed miRNAs. The HEs made by Applicant and used successfully in the treatment methods clearly express all of miRNA-214, miRNA-199A-3p, and miRNA-335 (see Table 5).
The drawings fail to provide support for the method as currently claimed. Additionally, while sufficient relevant identifying characteristics for the HE cells used to successfully treat the conditions as claimed are presented, including having unique miRNA markers including all of miRNA-214, miRNA-199A-3p, and miRNA-335, such identifying characteristics, including the differences in function provided by the absence of one or more of the identified miRNA markers, is not provided. While the level of skill in the art is high, the art is unpredictable. There is no indication that HE cells with only one or two of the unique miRNA markers found in the J1-HE cells would necessarily be capable of providing successful treatment to a subject who would benefit from treating a vascular disease, increasing blood flow in pulmonary arteries, or reducing blood pressure, or even be safe for administration to the subject.
For the forgoing reasons, the disclosure would not lead one of skill in the art to the conclusion that the Applicant was in possession of the invention as currently claimed. Claims 3, 5, 12, 15, 16, 35, 37, and 76-78 are included in this rejection, as these claims depend from above rejected claims, and fail to remedy the noted deficiency.
Response to Arguments
In view of Applicant’s amendments, all previous rejections have been withdrawn. Therefore, Applicant’s arguments are moot. However, new rejections have been set forth above.
Conclusion
No claims are allowable.
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 JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila G. Landau can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
