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 .
Priority
This application filed 07/24/2023 is a Continuation of PCT/CN2021/139502, filed 12/20/2021, and claims foreign priority to 202111089547.X, filed 09/16/2021. The claims are therefore examined as filed on 09/16/2021, the effective filing date. In future actions, the effective filing date of one or more claims may change, due to amendments to the claims, or further review of the priority application(s).
Claim Status
Claims 1-2 are pending.
Claims 1-2 are examined.
Claims 1-2 are rejected.
Information Disclosure Statement
The Information Disclosure Statements are in compliance with the provisions of 37 CFR 1.97. Accordingly, all references have been considered.
Specification
The disclosure is objected to because it contains several embedded hyperlinks and/or other forms of browser-executable code (see pages 6-8). Applicant is required to delete the embedded hyperlinks and/or other forms of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-2 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite because it is a “use claim”, which is an attempt to claim a process without setting forth any steps involved in the process (see MPEP 2173/05(q)). Claim 1 refers to “the use of a gene combination in preparing a tissue chip” but does not provide any steps on how to prepare a chip, and instead provides information defining the chip (describing what the chip comprises). It is unclear if the claim is actually intended to be directed to a method of chip preparation, to the chip itself, to a method of gene detection, or to something else.
Claim 1 is also unclear with regards to the tissue chip comprising “a gene model for judging the prognosis of hepatocellular carcinoma” in addition to the gene probe – it is unclear how the tissue chip itself comprises this model, or if this is an analysis method intended to be performed based on results obtained from the chip (and not stored on the chip itself). The claim is therefore indefinite due to lack of clarity.
Claim 2 is also indefinite as it depends from claim 1, and does not resolve the issues above.
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 1-2 are rejected under 35 U.S.C. 101 as they are considered “use claims” as described in the 112(b)rejection above. "Use" claims that do not clearly purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101 (see MPEP 2173/05(q)).
The MPEP at MPEP 2106 sets forth steps for identifying eligible subject matter:
(1) Are the claims directed to a process, machine, manufacture or composition of matter?
(2A)(1) Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea?
(2A)(2) Do the claims recite additional elements that integrate the judicial exception into a practical application?
(2B) If the claims recite a judicial exception and do not integrate the judicial exception, do the claims recite additional elements that provide an inventive concept and amount to significantly more than the judicial exception?
With regard to step (1) (Are the claims directed to a process, machine, manufacture or composition of matter?): No. The claims are not directed to one of the statutory classes, as they are not clearly directed to a process (method), machine, manufacture or composition of matter.
As such, the remaining steps are not applicable, and the claims are ineligible under 35 U.S.C. 101.
Claims Without an Art Rejection
No art rejection is applied to claims 1-2. Close art, for example XIONG 2020, while teaching a prognostic risk model for hepatocellular carcinoma using gene expression levels, does not teach the specific combination of genes or risk score calculated using the expression of these genes as described in the instant claims, and no combinable art before the effective filing date could be found to render the claims as obvious.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
KAUR 2020 “Identification of Platform-Independent Diagnostic Biomarker Panel for Hepatocellular Carcinoma Using Large-Scale Transcriptomics Data” teaches determining a combination of biomarker genes for predicting HCC patients
XIONG 2020 “A novel prognostic models for identifying the risk of hepatocellular carcinoma based on epithelial-mesenchymal transition-associated genes” teaches a prognostic risk model for hepatocellular carcinoma using epithelial-mesenchymal transition-associated genes
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY C LEVERETT whose telephone number is (571)272-5494. The examiner can normally be reached 8:00am - 5:00pm M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz R. Skowronek can be reached at (571) 272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY C LEVERETT/ Examiner, Art Unit 1687
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