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 .
Status of the Claims
Claims 1-2, 4, 7-10, 13-14, 72-73, 78-79, 83, 92, 94, 96, 103, 105, 107, 109-111, 133, 159-161, 163-164, and 169-170 are pending (claim set as filed on 10/20/2023).
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 05/21/2026 is acknowledged. The traversal is on the grounds that the groups are part of an overlapping search area such that a search and examination of the entire application would not place a serious burden on the Examiner. This argument is not persuasive because the restriction requirement is based upon a lack of unity and not serious burden. In other words, search/serious burden is for U.S. restriction practice whereas the instant application is based upon 371 unity of invention restriction practice. Thus, the groups lack a special technical feature as explained below.
Claims 72-73, 78-79, 83, 92, 94, 96, 103, 105, 107, 109-111, 133, 159-161, 163-164, and 169-170 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 1-2, 4, 7-10, and 13-14 are presented for examination.
Priority
This application is a 371 of PCT/CN2022/088016 which has a foreign application to CN 202110429176.9 filed on 04/21/2021.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 10/20/2023 and 12/30/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Drawings
The drawings filed on 10/20/2023 have been accepted.
Claim Rejections - 35 USC §101, Subject Matter Eligibility
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 1-2, 4, 7-10, and 13-14 are rejected under 35 U.S.C. 101 because they are drawn to ineligible subject matter (based on the 2019 Revised Patent Subject Matter Eligibility Guidance).
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a process of identifying dopaminergic neural precursor cells.
STEP 2A: PRONG ONE: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
YES, the claims recite at least one judicially recognized exception(s) of: a law of nature, natural phenomenon, and/or an abstract idea. In particular, under the broadest reasonable interpretation, the base claim’s recitations of “identifying”, “determining”, and “dopaminergic neural precursors cells” denotes the judicial exceptions.
a law of nature/natural phenomenon: the recitation of “dopaminergic neural precursors cells” describes natural products that already exists in nature.
(b) an abstract idea: the recitation of “identifying” and “determining” under BRI describes an abstract idea that falls within the mental processes groupings of abstract ideas which are concepts performed in the human mind (including an observation, evaluation, judgment, or opinion).
PRONG TWO: Does the claim recite additional elements that integrate the judicial exception into a practical application?
NO, the exception is not integrated into a practical application of the exception. The additional elements or a combination of elements in the claims does not impose a meaningful limit on the judicial exception. For example, the claims stop after the judicial exception and thus, it does not apply or use the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see Vanda Memo).
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
NO, the claimed invention is directed to a law of nature/natural phenomenon, and/or an abstract idea without significantly more. The claim(s) recite(s) the identification and determination of dopaminergic neural precursor cells which denotes the judicial exception(s) where under BRI describes an abstract idea that falls within the mental processes groupings of abstract ideas which are concepts performed in the human mind (including an observation, evaluation, judgment, or opinion) (MPEP 2106.04(a)). This judicial exception is not integrated into a practical application because the additional elements of obtaining a sample in order to perform tests is well-understood, routine, and conventional activity for those in the field of diagnostics. Further, the steps are recited at a high level of generality such that it amounts to insignificant pre-solution activity, e.g., a mere data gathering step necessary to use the correlation that dopaminergic neural precursors express a certain type of markers. The determining, evaluating, and comparative steps are considered various common practices that are routine and conventional activities performed by visual observation, abstract mental analysis, and pathological side by side comparison. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. The claim here does not invoke any of the considerations that courts have identified as providing significantly more than the exception.
Moreover, the dependent claims are not deemed to qualify as significantly more because they do not add a specific limitation other than what is well-understood, routine, and conventional in the field. Therefore, when the additional elements are viewed as an ordered combination, they are not deemed to add meaningful limits on the use of the exception.
Therefore, the claims, as a whole, are considered as processes directed to judicially recognized exceptions without amounting to significantly more from what occurs in nature and thus, are not eligible subject matter under 35 U.S.C. §101.
Claim Rejections - 35 USC §102, Anticipation
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.
Claims 1-2, 4, 7-10, and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 2021/0093673 A1 - cited in the IDS filed on 10/20/2023).
Kim’s general disclosure relates to a method for separation of dopaminergic neural cells and a pharmaceutical composition comprising dopaminergic neural cells separated thereby for treatment of Parkinson’s disease (see abstract & ¶ [0001]).
Regarding claims 1 and 7-10 pertaining to the identification step, Kim teaches the identification and isolation dopaminergic neurons by specific surface markers that could distinguish and enrich dopaminergic neurons (see ¶ [0010]-[0013]). In particular, Kim teaches “a differentiation protocol with stepwise specifications of mDA neurons and develop cell surface markers in each stage … an LMX1A-eGFP reporter hESC line which is manipulated to express green fluorescent protein (eGFP) concurrently with LMX1A, which is an mDA neural progenitor stage specific gene, and a PITX3-mCherry reporter hESC line which is manipulated to express a red fluorescent protein (mCherry) concurrently with PITX3, which is a mature mDA neuronal stage-specific gene. Transcriptome analysis of LMX1A+ mDA neural precursor cells and PITX+ mDA neural cells revealed cell surface marker candidates specifically expressed on progenitors of mDA neural cells (neural precursor cells). Among them, TPBG was discovered as a novel cell surface marker” (see ¶ [0015], [0020]-[0021]). Kim teaches TPBG-positive cells positive for all the three markers (EN1, FOXA2, and LMX1A) were also significantly enriched (see ¶ [0188]-[0189]). Kim further teaches identification of mDA marker candidates where “comparative microarray analysis of the four isolated cells identified upregulated genes in LMX1A+ cells, and PITX3+ cells relative to their reference cells LMX1A cells and PITX3- cells (>2-FC). Among the upregulated genes, 53 candidate genes coding for cell membrane proteins having extracellular domains were identified by gene mining. The 53 identified genes included a number of genes known to be specific for mouse mDA progenitors (Corin, Clstn2, Kitlg, Plxdc2, Pcdh7, Ferd31, Freml, Alcam, and Notch2)” (see ¶ [0161]-[0164]).
Regarding claims 2 and 4 pertaining to the dopaminergic neural precursor cells, Kim discloses “As used herein, the term ‘neural cells’ refers to cells constituting the nervous system and is used in the same meaning as neurons, and ‘dopaminergic neural cells’ means neural cells secreting the neurotransmitter dopamine. The dopaminergic neural cells may be dopaminergic neural progenitors or dopaminergic neural precursor cells, or mature dopaminergic neurons, but are not limited thereto. As used herein, the term ‘neural progenitors or neural precursor cells’ means undifferentiated precursor cells that have not yet expressed a differentiated characteristic, and ‘progenitors’, ‘precursors’, and ‘precursor cell’ may be used interchangeably” (see ¶ [0028]-[0031]-[0032]). The human stem cells or precursors may include embryonic stem cells, embryonic germ cells, embryonic carcinoma cells, induced pluripotent stem cells (iPSCs), adult stem cells, and fetal cells, but are not limited thereto (see ¶ [0035]-[0038]).
Regarding claims 13-14, Kim teaches “target validation was assessed by examining whether the genes were expressed in mDA cells that were practically differentiating. As a result, among the targets, surface marker genes were identified to be upregulated in LMX1A+ cells relative to LMX1A- cells (FIG. 14) and upregulated or downregulated in both LMX1A + cells and PITX3+ cells (FIG. 15). Commercially available antibodies were screened against 18 genes among 21 genes” (see ¶ [0165]).
Conclusion
No claims were allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NGHI V NGUYEN whose telephone number is (571)270-3055. The examiner can normally be reached Mon-Fri: 9 - 3 pm (ET).
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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