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 .
DETAILED ACTION
This application is in response to the papers filed on April 16, 2026. Claims 1-20 are currently pending as per claims filed on March 25, 2024.
Applicant’s election without traverse of the invention of Group I, e.g., claims 1-7, drawn to a method for screening a substance, in the reply filed on April 16, 2026 in response to the Restriction Requirement filed on February 25, 2026 is acknowledged.
Claims 8-20 are withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Reinstatement of claims drawn to non-elected inventions will be withdrawn during prosecution. The requirement for restriction between Groups I-III is maintained for reasons of record, and hereby made FINAL. Applicant timely responded to the restriction (election) requirement in the Paper filed on April 16, 2026
Therefore, claims 1-7 are currently under examination to which the following grounds of rejection are applicable.
Priority
Acknowledgement is made of applicant’s claim of benefit under 35 U.S.C. 119(e) of prior-filed provisional application 63/491,876, filed on March 23, 2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 25, 2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or an official IDS, they have not been considered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 fails to further limit the scope of claim 1 based on “the subject” recited in claim 1, line 9 being understood as the same subject from which the somatic cells are provided; and claim 2 stating “the subject” as being the same than the subject from which somatic cells are provided.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Applicant is directed to the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on 1/07/2019, which is found at: https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf; and the October 2019 Update: Subject Matter Eligibility, which is found at https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf.
Briefly summarized here, the new guidance cites a two part test: is the claimed invention directed to a statutory class of invention (Step 1), if so then is the claimed invention as a whole directed to a law of nature, natural phenomena, or an abstract idea (i.e. set forth or described in the claim) (Step 2A, prong one), if so then is the claimed invention recite additional elements that integrate the judicial exception into a practical application (Step 2A, prong two), if not then does the claim as a whole amount to significantly more than the judicial exception (Step 2B).
Step 1:
Regarding step 1, the claims are directed to a method for screening a substance, which falls under the statutory category of a process. Accordingly, the requirements of Step 1 are met.
Step 2A, Prong One:
In regard to Step 2A prong one, claim 1 directed to a method for screening a substance comprising the step of “determining whether or not to administer or apply the substance to the subject based on a response of the differentiated cells to the substance” is a mental process; and therefore is the judicial exception of an abstract idea.
Claim 7 is directed to the method comprising “ the response of the differentiated cells [that the determination is based on] is a survival rate of the differentiated cells” is a mental process; and therefore is the judicial exception of an abstract idea.
Applicant is directed to MPEP 2106.04(a)(2) (III) which states that the courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) ("‘[M]ental processes[] and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978).
In the instant case, regarding claim 1, “determining whether or not to administer or apply the substance to the subject based on a response of the differentiated cells to the substance” can be performed merely by looking at the cell, and therefore the recited step is a mental process.
Regarding claim 7, the step of “ the response of the differentiated cells is a survival rate of the differentiated cells” can be performed in the human mind by looking at the cells, observing whether they are alive or dead, and calculating the efficiency at a given time, and therefore the recited step is a mental process.
Since the claims recite a judicial exception, the additional elements of the claims then analyzed to determine whether the judicial exception is integrated into a practical application (Step 2A prong two), and whether the claim as a whole amounts to significantly more than the judicial exception (Step 2B).
Step 2A Prong Two:
In regard to Step 2A prong two, the judicial exception is not integrated into a practical application.
Claim 1 recites the following additional elements:
“inducing pluripotent stem cells from somatic cells of a subject;”
“inducing differentiated cells from the pluripotent stem cells;”
“adding a substance to the differentiated cells and culturing the differentiated cells;”
The step of introducing the substance do not integrate the mental process into a practical application because they are merely insignificant extra solution activity of necessary data gathering and outputting. All uses of the recited judicial exception require such data gathering or data output because screening a substance requires analyzing some basis of data upon which to screen the substance. The specific recited steps are merely specific well-known ways to perform such data gathering or data output and therefore these recites steps do not integrate the judicial exception into a practical application (see MPEP 2106.05(g)). Furthermore, the steps of induction are considered routine, and well-known steps in the field of cell culturing; and in combination as a whole does not amount to significantly more than the judicial exception.
Regarding claim 7, the claim does not recite additional elements other than the mental steps discussed above and therefore the claim cannot integrate into a practical application.
Step 2B:
In regard to Step 2B, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
As stated above (see Step 2A prong one above), the additional elements recited are necessary data gathering and outputting which do not integrate the claims into a practice Application and therefore also do not amount to significantly more. The recited specific steps of induction and adding a substance
do not amount to significantly more because they recited steps are well-understood routine and conventional.
Regarding claim 7, Applicant is directed to the art of Bohlen et al. (US-8,318,488-B1) which evidences the steps of “adding a substance to the differentiated cells and culturing the differentiated cells; and determining whether or not to administer or apply the substance to the subject based on a response of the differentiated cells to the substance.” (“In particular, the present invention relates to a method for identifying and/or obtaining a drug for the amelioration or treatment of a disease or for determining the toxicity of a compound comprising contacting a test sample comprising an in vitro differentiated cell with a test substance to be screened, wherein said cell is induced to display a predefined diseased phenotype which substantially corresponds to a phenotype of a diseased cell, tissue or organ; and determining a responsive change of the phenotype in said test sample, wherein a responsive change preventing or delaying the onset or the progression of the diseased phenotype is indicative for a useful drug, and enhancing the onset or progression the diseased phenotype is indicative for the toxicity of the compound.” (Field of the Invention); “In one preferred embodiment, said phenotype in the method of the present invention is induced by culturing the in vitro differentiated cell in the presence of a physiologically active compound.” (col 23, ln 25-30).
Furthermore, the steps of reprogramming and differentiation are well-known in the art as described in the Description of Related Art section of the Specification, in which the listed Ban et al. (US-2016/0215270-A1 as listed on the IDS filed March 25, 2024), describes these methods for reprogramming somatic cells to iPSCs and then differentiating these cells to select cell fates (par 0086-0088). Therefore, because these steps are well-known, routine and conventional, they cannot amount to insignificantly more than the mental process judicial exception.
Regarding claim 7, the claim does not recite additional elements other than the mental steps discussed above and therefore the claim cannot amount to significantly more.
Judicial Exception – Conclusion
Therefore, the claims are directed to an abstract idea (mental process of screening the candidate drug on the basis of the neural cell) that is not integrated into a practical application, does not include elements that amount to significantly more than the abstract idea, and does not qualify as patent eligible subject matter under 35 U.S.C. § 101.
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 1-7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tanabe et al. (US-2022/0088087-A1; filed on October 4, 2019).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Tanabe teaches a method for screening a substance, comprising: inducing pluripotent stem cells from somatic cells of a subject; inducing differentiated cells from the pluripotent stem cells (“a method for screening for anti-ultraviolet substances including: providing skin cells by induction of differentiation from pluripotent stem cells produced from somatic cells derived from an aging disease patient or a skin disease patient;” (par 0038); “screening for anti-dryness substances” (par 0039); “screening for anti-oxidation stress substances” (par 0042); “screening for moisturizing-promoting substances” (par 0043)) adding a substance to the differentiated cells and culturing the differentiated cells (par 0038-40, 42-43, 92, 99, 0107, and 0113); and determining whether or not to administer or apply the substance to the subject based on a response of the differentiated cells to the substance (“selecting a culture medium for which a UV-induced damage to the skin cells is little or a solution for which the ultraviolet-dosed skin cells are rapidly recovered, is provided.” (par 0038; 0039-40, 42-43).
Regarding claim 2, dependent on claim 1, the rejection to claim 1 describes wherein the subject from which the somatic cells are provided and the subject to which the substance is administered or applied are the same person (par 0038).
Regarding claim 3, dependent on claim 1, Tanabe teaches wherein the substance is an additive of a beauty product, a cosmetic product, a hair tonic, or a hair growth promoter (“anti-ultraviolet substance” (par 0095); “anti-dryness substance” (par 0100); “anti-oxidation stress substance” (par 0108); “moisturizing-promoting substance” (par 0114); “hyaluronic acid” (par 0128); “iPS cell extract liquid has a hair restoration effect and a hair growth effect such as treating thin hair, preventing alopecia, promoting hair formation, and promoting hair growth” (par 0134)).
Regarding claims 4-6, all dependent on claim 1, Tanabe teaches wherein the substance is an additive of a pharmaceutical drug, a vitamin, and/or an antiseptic agent (par 0087-0090).
Regarding claim 7, dependent on claim 1, Tanabe teaches wherein the response of the differentiated cells is a survival rate of the differentiated cells (“Thereafter, the survival rate of the skin cells cultured in each of the plurality of solutions is measured, and a solution that exhibits a high skin cell survival rate is selected as a solution that contains an anti-dryness substance.” (par 0101)).
Conclusion
Claims 1-7 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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