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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/16/26 has been entered.
Applicant's arguments filed 1/16/26 have been fully considered but they are not persuasive. The claims remain rejected for the reasons of record.
Claim 19 is considered in this action, not withdrawn.
Applicant has amended the claims to indicate that the cells are now required to be “a sheet.”
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) 1-2, 4-11, 17, 19, 21 & 25 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 cell population predominately comprising alveolar epithelial or alveolar epithelial cells which are CPM positive.
The specification (and at least claim 2) indicates that the cells are isolated from a subject by selecting for CPM. The markers claimed all are inherent properties of the cells and used to identify the cell as such.
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 or composition of the population has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring cells and molecules.
The limitation “sheet” describing the cells has been introduced to the claims but the claims still requirement nothing more than the cells per se and whether the cells form a sheet or not would not appear to make the cells markedly different from the natural cells especially because the specification merely indicates that (p 31) cells “are formed into a sheet” and there is no indication what the parameters of such a sheet are. The broadest reasonable interpretation of “sheet” absent an explicit definition could be any simple linear array of the cells and that would not appear to be different from the product of nature. Even if there would be considered to be an actual difference, said difference would not appear to be markedly different in that the cells can be isolated and/or manipulated in vitro as in culturing and the cells per se not differ markedly from the product of nature absent and showing to the contrary.
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.
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BLAINE LANKFORD
Examiner
Art Unit 1657
/BLAINE LANKFORD/Primary Examiner, Art Unit 1657