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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/25/2025 has been entered.
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.
Claims 70-77 and 86, as amended or newly added, are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more.
According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of matter). Claims 70-77 are drawn to a composition of matter comprising a population of cells. Thus claims 70-77 meet the requirements for step 1 of the analysis.
Second, the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application).
Regarding the first prong (1), claims 70-77 are directed to a population of undifferentiated cells, wherein the cells are selected from MSC, mesenchymal progenitor cells, and mesenchymal stromal cells.
The specification teaches that the undifferentiated stem cells are cells present in and isolated from adipose tissue, bone marrow, synovial membrane, cord blood, Wharton’s jelly or amniotic fluid (paragraph [0014] of pre-grant publication). As such, the specification provides evidence that the claimed undifferentiated cell exist in nature in adipose tissue, bone marrow, synovial membrane, cord blood, Wharton’s jelly or amniotic fluid. Therefore, the claims are directed to a product of nature, which is a judicial exception.
Regarding the second prong (2), claims 70-77 solely recite additional structural elements of the undifferentiated cell product. As such, the claims do not recite any additional elements or a combination thereof that integrates the judicial exception identify in prong 1 as being integrated into a practical application . Further since the claims are not meaningfully limited to any particular practical application, the generic nature of the claim appears to monopolize the claimed cell population. Thus, claim 70-77 meet the requirement of step 2A as being directed to a judicial exception.
Third, if a judicial exception is present in the claim, it is further assessed to determine if the claim recites any additional elements or steps that are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception.
Claim 70 additionally recites that the cells are “at least 60% of the cells of the population express integrin α10 subunit and are MHCII negative and CD45 negative”. Neither the claim nor the specification recite/teach that these markers are exogenously introduced but rather teach that these markers are endogenous markers of a subpopulation. The claim also recites that it is “enriched”. “Enriched” means that the cells are treated to remove other cell types. It does not change the structure of the undifferentiated cells from those found in nature. As such, no additional elements are recited that would markedly distinguish the undifferentiation cell population from the one found in nature.
The amendment to claim 70 recites that claims cell population is in a composition comprising isolated, cultured, and enriched cells. Again as discussed above and below, Myriad is clear that an isolated but otherwise unchanged natural product does not amount to significantly more than the natural product judicial exception. Also as discussed “enriched” does not structurally or functionally change the cell. Cultured indicates that the cell is in a culture, which again is the same as isolated but unchanged in structure and function of the cell. As such, the amended to the claims do not recite new additional limitations that markedly distinguish the claimed composition from it natural counterpart.
Claims 71 specifies that the cells are autologous or allogenic. This specifies the source of the cells and does not impart any further structure or function that would markedly distinguish the cell population from its natural counterpart.
Claim 72 further specifies that percentage of cells present in the population that are the undifferentiated cell population. The claim does not distinguish the cells from that cell found in nature in any way, just how many of them are present. As such, the claim does not impart a marked distinction from the product of nature.
Claim 73 specifies that the cells are in vitro. While this does impart the distinction of being isolated and place in a container of some sort outside of the body, it does not impart any distinction to the cell other than isolated.
Under the holding of Myriad, an isolated but otherwise unchanged nucleic acid was not patent eligible subject matter because it was not different enough from what exists in nature to avoid improperly tying up the future use and study of naturally occurring nucleic acid. The instant claims are analogous to this situation in Myriad. "In vitro" without any specifying description of the in vitro conditions can be interpreted as cell isolation. As such, the claimed cell product can be interpreted as isolated but otherwise an unchanged undifferentiated cell and thus not patent eligible subject matter because it is not different enough from what exists in nature to avoid improperly tying up the future use and study of the naturally occurring undifferentiated cell. As such, recitation of “in vitro" fails to amount to a marked distinction from it natural counterpart.
Regarding claims 74-75, these claims specify the antibody by which the undifferentiated cells are isolated. They do not impart any structural or functional distinction to the undifferentiated cells that would distinguish them from the natural counterpart.
Regarding claim 76, this claim describes the origin of the cell and does not impart any structural or function distinction to the undifferentiated cells that would distinguish them from the natural counterpart.
Regarding claim 77, this claim specifies additional markers expressed by the cells. The specification teaches that these are endogenous markers, not ones introduced exogenously. As such, expression of the claimed markers are a natural function the undifferentiated cell and thus do not impart any distinction to the natural product.
Overall, claims 70-77 do not meet the requirements of step 2B of the 2019PEG because the claims solely recite the undifferentiated cell that is not markedly different from its natural counterpart.
Regarding the amendments to the claim:
Claim 70, as amended and new claim 86 add product by process language to provide the method by which the claim cell population is made. Regarding Step 1A, claim 70, dependents, and new claim 86 are still a composition of matter and thus the requirements for step 1A have been meet. Regarding step 2A, prong 1, claim 70, dependents, and new claim 86 recites a cell population, thus is directed to a product of nature. As such the claims are still directed to a judicial exception as required for step 2A, prong 1. Regarding prong 2, claim 70, depends, and new claim 86 recite additional recite processes by which the claimed judicial exception is made, but does not recite any additional elements that would be deemed a practical applications. As such, under prong 2 analysis, the claims are directed to a judicial exception with no integration into a practical application. Regarding step 2B, the product by process language provide a means of making the cell population but does not evidently structurally distinguish the cells population as one markedly different from the natural counterpart discussed above. As such, the claims do no meet the requirements for step 2B.
In conclusion, claims 70-86 do not meet all the requirements of the 2019PEG and therefore deemed patent ineligible.
Response to Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive.
Applicant traverses the rejection. First, Applicant reiterate argument previously address in prosecution. In response Examiner refers Applicant to previously prosecution for the rationales as to why these arguments are not found persuasive. Applicant argues that the MSC population of the claims expression high α10 integrin subunit which is not expressed by naturally occurring MSC populations. Applicant refers to Varas 2007 (of record), which Applicant submits teaches only 15% of MSC isolated from bone marrow express α10 integrin subunit, whereas the claimed MSC population has at least 60% of the MSC expressing α10 integrin subunit. Therefore, the claimed MSC population has a markedly different phenotype than naturally occurring MSC populations.
In response, Vargas reports, “In extensive monolayer cultures of MSC, α10 integrin is down-regulated. We show this down-regulation is reversed by fibroblast growth factor-2 (FGF-2)”. See abstract. As such, Vargas demonstrates that when a culture environment is changed, α10 integrin subunit expression changes. However, the MSC are still the same MSC cells. As such, Vargas demonstrates that that marker expression profiles are subject to change depending upon culture environment. As such, contrary to Applicant’s assertion, high or low expression profiles of α10 integrin subunit are not a marked distinction of the claimed cell population but rather a distinction of the culture environment in which the cell is cultured. Thus, Applicant argument is not found persuasive in demonstrates that the claimed composition is markedly different from its natural counterpart.
Applicant also refers to Example 9 of the 2014 eligible subject matter guidelines and states that the presently claimed cells are analogous to the cells of claim 3 in the example which are deemed patent eligible.
In response, the fact pattern is not analogous because the explanation as to why claim 3 patent eligible is not the same as the instant claims. Example 9, claim 3 explain that differential expression patterns claimed do not make claim 3 patent eligible. However, the disclosure in the example that the claimed population of cells grow faster than the natural counter part did demonstrate a marked distinction, which made claim 3 eligible. The instant claims do not have a demonstrated alteration in phenotype of the cell and only demonstrated alteration in expression profiles of α10 integrin subunit, which Vargas demonstrates is subject to changes based upon changes in culture conditions. As such, Applicant’s arguments are not persuasive.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632