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 .
Claim Objections
The numbering of claims is proper now.
Claim Rejections - 35 USC § 112
The rejection under 35 U.S.C. 112(b) has been overcome by applicant’s amendment and arguments.
Applicant's arguments filed 12/15/25 have been fully considered but they are not persuasive. Applicant has amendment claim 75 (and other corresponding claims) to indicate that the claimed cell is a “modified iPSC-derived” cell. The limitation “modified” without an actual qualifier does not lead to a claim requires the claimed cell to have markedly different characteristics from what occurs in nature. It also not necessary that iPSC-derived cells would necessarily have markedly different characteristics from what occurs in nature particularly where the characteristics claimed are not distinct from the natural cell.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) 75-97 is/are directed to a naturally occurring cell population. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims are drawn to a composition of matter.
The claims are drawn to a natural phenomenon, namely the occurrence in nature of a human cell population that expresses CD34 and CD31 and can differentiate into at least 4 cell types, e.g. MSC, HSC, smooth muscle & functional endothelial cells, Claim 12 requires CD45. Claim 14 requires vWF and CD144. Claim 17 requires CD90, CD73, and CD105 in the absence of CD31 and CD45. The other dependent claims recite further inherent functional properties of the cells. require
The instant specification describes the invention as a cell produced from IPSCs but as IPSCs differentiate into cells that are the same as natural precursors or ultimately differentiated cells, it follows that the instant cells produced at IPSCs are the same as naturally occurring cells and thus the claims are drawn to a judicial exception to patentability.
The claims are drawn to the cells per se and thus this judicial exception is not integrated into a practical application.
The specification contains no evidence, that the culturing of the cells imparts characteristics markedly different from those cells as they exist and function in nature. As such, there is no evidence that the claimed population has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring cells and molecules.
For these reasons, the claimed invention does not appear to have markedly different characteristics from what occurs in nature and is a “product of nature” exception. Accordingly, the claim is directed to an exception.
The claimed invention does not include any additional features that could add significantly more to the exception, so the claim does not qualify as eligible subject matter.
Concluding the analysis, the claimed invention is drawn to a judicial exception to the statute and must be rejected as ineligible under 35 USC101.
Conclusion
THIS ACTION IS MADE FINAL. 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 BLAINE LANKFORD whose telephone number is (571)272-0917. The examiner can normally be reached M-Th 8-6:30.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657
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