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 .
Applicant's submission filed on 9/1/2026 has been entered. Claims 1, 3, 19-20 and 27-32 are pending in the instant application.
Election/Restrictions
Applicants previously elected Group I, methods of regulating differentiation, dedifferentiation, transdifferentiation, aging and apoptosis of target cells by activating or inhibiting the JAK-STAT signaling pathway in target cells. Applicants further elected species of the method wherein:
the JAK-STAT signaling pathway is inhibited
the STAT5A and/or STAT5B gene is targeted, and
fibroblasts are the targeted cell type.
Due to the significant amendments to the claims, the only remaining relevant detail is: fibroblasts are the targeted cell type.
Claims 1, 3 and 27-29 read on the elected invention and elected species. Claims 19-21 and 30-32 are withdrawn from consideration as being directed to non-elected invention and/or species.
Claim Interpretation
As amended, claim 1 is drawn to a method of regulating differentiation, dedifferentiation, transdifferentiation, rejuvenation, aging and apoptosis of fibroblasts, the method comprising:
treating the fibroblasts with a composition consisting of:
HG-DMEM,
FBS or human platelet concentrate, and
a small molecule mixture,
wherein the small molecule mixture consists of a small molecule combination selected from [one of the five options recited].
Due to the language limiting the ‘treatment composition’ (Examiner’s term, referring to the composition with which the fibroblasts are treated) to consisting of the specified items, no additional elements can be present.
Status of Prior Rejections/Response to Arguments
RE: Rejection of claims 1, 3, and 27-29 under 35 USC 112(b):
The amendment to claim 1 is effective to overcome the rejection of record.
The cancellation of claim 34 renders the rejection of record moot.
The rejection is withdrawn.
RE: Rejection of claims 1, 3, and 27-29 under 35 USC 103 over Lu et al:
The amendment to claim 1 to limit the ‘treatment composition’ to consisting of the claimed components is sufficient to differentiate over Lu et al. The method of Lu et al involves treatment the fibroblasts with small molecules beyond those listed in the five recited ‘small molecule mixtures’. The rejection is withdrawn.
RE: Rejection of claims 1, 3, and 27-29 on grounds of NSDP over claims of each of US Patents 11674122 and 12324817:
Applicants filed terminal disclaimers over each US Patent. The terminal disclaimers have been approved and recorded. The rejections are withdrawn.
New Rejections
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 and 27-29 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 has been amended to recite that the ‘treatment composition’ contains, inter alia, human platelet concentrate. There is no support for inclusion of human platelet concentrate. Applicants assert that FibGro Medium (cat. No. FGS0040), referenced at Pg 22 of the specification, contains platelet concentrate, and thus provides support. However no evidence is provided to support this assertion. (Applicants state an attachment was provided with the response, but no such attachment was received. The website provided does not provide meaningful information.) Even if the attachment did provide evidence that platelet concentrate was present within FibGro Medium, this would not provide support for inclusion of isolated platelet concentrate in combination with HG-DMEM and the claimed small molecule mixtures. The specification teaches FibGro (of which platelet concentration might be a component) and the claimed small molecule mixtures, the specification does not teach FibGro in combination with HG-DMEM and the claimed small molecule mixture. This is a new matter rejection.
Examiner Comment
The following amendment to claim 1 would place claims 1, 3, and 27-29 into condition for allowance:
1. A method of regulating differentiation, dedifferentiation, transdifferentiation, rejuvenation, aging and apoptosis of target cells, comprising:
treating the target cells with a composition consisting of high glucose DMEM (HG-DMEM) supplemented with a small molecule mixture, and fetal bovine serum (FBS)
wherein the target cells are fibroblasts, and
the small molecule mixture consists of a small molecule combination selected from the group consisting of:
Valproic acid (VPA), CHIR99021, Repsox, Forskolin, SP600125, Go 6983, Y-27632, Vitamin C (Vc), TTNPB, AM580 and EPZ004777;
VPA, CHIR99021, Repsox, Forskolin, Go 6983, Y-27632, Vc, TTNPB, AM580 and EPZ004777;
Ruxolitinib and S3I-201;
Y-27632, Vc, EPZ004777, Forskolin and Repsox; and
VPA, CHIR99021, Repsox, Forskolin, Go 6983, Y-27632, AM580 and EPZ004777, Vc, TTNPB and 5-Aza-2’-deoxycytidine.
On 9/11/2026 an attempt was made to contact Applicants’ representative at the listed phone number (917-588-0481), but the voice mailbox was full.
Conclusion
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 ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 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, Christopher Babic can be reached on 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ALLISON M FOX/Primary Examiner, Art Unit 1633
Prosecution Insights