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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/29/2025 has been entered.
Claim Status
As of the Final Office Action mailed 7/10/2025, claim 14 was pending.
In Applicant's Response filed on 9/29/2025, claim 14 was amended.
As such, claim 14 is pending and has been examined herein.
Maintained Rejections
Applicant’s arguments regarding the rejection of record of claim 14 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Niedernhofer (US 20130336935 A1, 7 June 2013; Published 19 Dec 2013) as evidenced by Baljevic et al (Blood 2008; 112 (11): 5449) have been fully considered but are not persuasive. Thus, the rejection has been maintained. Response to arguments will follow the recasted rejection.
Claim Interpretation
Claim 14 recites “the CD133+ EPCs are differentiated into endothelial cells to rejuvenate a microvasculature and extend a lifespan.” The only active method step recited in claim 14 is the administration of the EPCs. Therefore, everything following the administration step is a result of the active method step.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 14 remains rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Niedernhofer (US 20130336935 A1, 7 June 2013; Published 19 Dec 2013) as evidenced by Baljevic et al (Blood 2008; 112 (11): 5449).
Niedernhofer teaches a method of treating delaying, preventing, or reversing progeria (i.e., Hutchinson-Gilford progeria) or related syndromes in a mammal, comprising administering an effective amount of isolated autologous or allogeneic stem/progenitor cells to said mammals, wherein said cells secrete or release one or more regulatory factors; wherein said one or more secreted or released regulatory factors treat delay, prevent, or reverse one or more symptoms of progeria (see claim 20 of Niedernhofer). The said isolated stem/progenitor cell is selected from a group consisting of endothelial stem/progenitor cells (see claim 21 of Niedernhofer) (“A method for treating a Hutchinson-Gilford progeria syndrome, comprising administering a pharmaceutically effective amount of endothelial progenitor cells (EPCs) to a subject in need thereof, . . . and the CD133+ EPCs are differentiated into endothelial cells to rejuvenate a microvasculature and extend a lifespan.” as in instant claim 14; see claim interpretation above). Please note that the reference teaches that the administration rejuvenates and extends lifespan and promote neovascularization of a tissue in the mammal (abstract; para 0015). It also teaches that microvasculature in the brain of ERCC1-deficient mice is reduced in comparison to WT mice but the transplantation of induced angiogenesis in the brain (para 163).
Evidentiary reference Baljevic teaches that CD133, a pentaspan surface antigen, is considered a marker of tissue-specific stem cells, including hematopoietic stem cells and endothelial progenitors. It also states that CD133 expression is high on endothelial progenitor cells, becomes downregulated during their differentiation, and it is not found on mature endothelium. Thus, the endothelial progenitor cells used to treat progeria as taught by Niedernhofer inherently express CD133, anticipating “wherein the EPCs are CD133+ EPCs” as in instant claim 14.
Response to Arguments
Applicant’s arguments have been fully considered but are not persuasive.
On p. 4 of Remarks, Applicant concedes that Niedernhofer discloses the use of EPCs to treat HGPS, but argues that the reference does not disclose the use of CD133+ EPCs in the treatment. Applicant argues that evidentiary reference Baljevic only discloses that CD133 is a marker of EPCs, that the teachings of Baljevic can only demonstrate that CD133 is one of a plurality of phenotypic profiles of EPCs, and that the Niedernhofer reference evidenced by Baljevic fails to anticipate that the EPCs used to treat progeria are CD133+. Applicant also argues that the mechanism in which the EPCs treat progeria in this invention is different by way of differentiating into endothelial cells and rejuvenating microvasculature. Applicant further makes arguments regarding a Zhang reference, stating that one of ordinary skill would lack the necessary motivation and skills to modify the method of Niedernhofer because Zhang does not teach, recite, or reasonably suggest the use of CD133+ EPCs to treat progeria nor the mechanism of action of the CD133 EPCs as claimed.
In response, the examiner disagrees. Applicant has conceded that the Niedernhofer reference in fact discloses Applicant’s instantly claimed method. Furthermore, while Niedernhofer does not explicitly describe the marker expression properties of the EPCs utilized in the method of treating, the Baljevic prior art reference shows that CD133 is an inherent property of the EPCs (as conceded by Applicant in the Remarks). "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Furthermore, the reference explicitly discloses that administration rejuvenates and extends lifespan and promote neovascularization of a tissue in the mammal. Applicant cannot run from the explicit disclosures of the prior art nor their own concessions. EPCs are known to be used to treat progeria, EPC administration extends lifespan and improves neovascularization (both shown by the Niedernhofer reference), and EPCs are known to express CD133 inherently (as shown by the Baljevic reference). An argument by the applicant is not evidence unless it is an admission, in which case, an examiner may use the admission in making a rejection (see MPEP 2145). Regarding the arguments related to the Zhang reference, the examiner notes on the record that no Zhang reference was utilized in previously mailed non-final or final Office actions, so any arguments regarding the alleged Zhang reference are moot. Thus, the rejection is proper and has been maintained.
Conclusion
No claim is allowed.
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/G.R./Examiner, Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632