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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-2, 5, 8-9, 11, 14, 16-17, 19-20, 24, and 29 in the reply filed on 11/03/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of the species of a “placental ASC” of claim 1 in the reply filed on 11/03/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 12-13, 18, 25-27, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Claims 8-9, 11, 17, 19, 20, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/03/2025.
Status of the Claims
Claims 1-2, 5, 8-9, 11-14, 16-20, 24-27, 29, and 32 are currently pending.
Claims 1-2, 5, 8-9, 11, 13-14, 16-17, 19-20, 24, 26-27, 29, and 32 are amended.
Claims 8-9, 11-13, 17-20, 24-27 and 32 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim.
Claims 3-4, 6-7, 10, 15, 21-23, 28 and 30-31 are cancelled.
Claims 1-2, 5, 14, 16, and 29 have been considered on the merits.
Claim Interpretation
Claim 1 contains limitations which are non-elected species. The elected species of a placental ASC is seen in item i. (b) a cultured placental ASC. Claim 1 is being effectively read as:
A method of enhancing a cellular or physiological function in a subject in need thereof, comprising contacting said subject with i. (b) a cultured placental ASC, thereby enhancing a cellular or physiological function in a subject.
Claim 5 contains two limitations, “where said cellular function is cellular aerobic respiration” and “said subcellular fraction comprises a naked or an encapsulated mitochondrion”. The second limitation containing a “subcellular fraction” is limiting a currently non-elected species of claim 1, and therefore the limitation is not being considered in the rejections below.
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.
Claims 1, 2, 5, 14, 16, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prather et al (Cytotherapy, 2009).
Regarding claim 1, Prather teaches a method of enhancing a cellular or physiological function in a subject in need thereof through contacting the subject with cultured placental adherent stromal cells (ASC), termed PLX-PAD by Prather (pg. 430, col. 1, para 3; and pg. 428, col. 2, para 3). Prather teaches that the PLX-PAD are administered through intramuscular injection as required by claim 2 (pg. 430, col. 1, para 3). Prather teaches that ASCs are isolated from placental tissue, grown on a 2D substrate, and subsequently grown in a 3D culture in a bioreactor; which results in the PLX-PAD as required by claims 14 and 16 (pg. 428, col. 2, para 3). Prather also teaches that the PLX-PAD express CD73, CD90, CD29, and CD105 and do not express CD14, CD19, and CD34 as required by claim 29 (pg. 429, Table 1). Prather teaches that the method results in the enhancing a cellular or physiological function, and that the cellular function is aerobic respiration through Figure 7. Figure 7 depicts results of testing oxidative stress and endothelial inflammation in subject administered control (PBS) and PLX-PAD treatment, in which the treatment group showed a reduction in both oxidative stress and endothelial inflammation. Prather teaches that the decrease in endothelial inflammation is “due to an increased oxygen supply in mice treated with PLX-PAD cells but not in control mice treated with PBS”, which meets the claimed requirements of an increase of aerobic respiration as required by claim 5 (pg. 433, Fig. 7 description).
Therefore, Prather anticipates the claims.
Conclusion
No claims are allowed.
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