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
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Priority of CHINA application 201811391555.8 filed 11/21/2018 is acknowledged.
Election/Restrictions
Applicant’s election of Group II claims 4-8 in the reply filed on 8/13/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 1 link(s) inventions Group I and Group II. The restriction requirement
between the linked inventions is subject to the nonallowance of the linking claim(s), claim 1. Upon the indication of allowability of the linking claim(s), the restriction requirement as to the linked inventions shall be withdrawn and any claim(s) depending from or otherwise requiring all the limitations of the allowable linking claim(s) will be rejoined and fully examined for patentability in accordance with 37 CFR 1.104. Claims that require all the limitations of an allowable linking claim will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
Applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, the allowable linking claim, such claim may be subject to provisional statutory and/or non-statutory double patenting rejections over the claims of the instant application.
Where a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claims 2-3 and 9-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. The restriction requirement is made final.
Claim status
Claims 2-3 and 9-15 are withdrawn.
Claims 1 and 4-8 are pending and are examined on the merits.
Claim Objections
Claim 5 recites “type B: the product of”, which should read as “type B: a product of”.
Claim 5 recites “type C: the product of”, which should read as “type C: a product of”.
Claim 5 recites “type D: the product of”, which should read as “type D: a product of”.
Claim 5 recites “type E: the product of”, which should read as “type E: a product of”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 –Second Paragraph
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 5 and 7-8 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 5 recites “the imprinted gene Peg10,” “the imprinted gene Snrpn/Snurf,” and “the imprinted gene Trapc9” in steps “type B”, “type C”, “type D”, and “type E”; claim 7 recites “the imprinted gene Peg10,” “the imprinted gene Snrpn/Snurf,” and “the imprinted gene Trapc9” genes in step (1). There is insufficient antecedent basis for these limitations in the claims.
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 and 4-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Step 1: Process, Machine, Manufacture or Composition
Claim 1 recites a prognostic marker, which is drawn to a “composition of matter.”
Claims 4-6 are drawn to "a prognostic typing model", which is not, in all embodiments of Broadest Reasonable Interpretation, interpreted as belonging to any statutory category listed in 35 USC 101. In a BRI, the claim reads on a mathematical model comprising no structure other than data and/or mathematical formulas. The claim is not recited as a process, and the claim is not limited to any particular structure as a 101 machine or manufacture. The claim reads on data and/or mathematical formulas which are not proper patentable subject matter because it does not fit within any of the four statutory categories of invention (In re Nuijten, Federal. Circuit, 2006).
In a BRI, each recited instance of a "model" reads on data and/or mathematical formulas in at least some embodiments.
None of the dependent claims remedy this rejection.
Claims 7-8 are directed to a process, here a "method," for creating the typing model of claim 4, with process steps including “performing”, “counting”, and “performing”.
Step 2A Prong One: Identification of Judicial Exceptions
The claim(s) recite(s):
Claim 1 recites a prognostic marker comprising imprinted gene Dcn, which is a natural product.
Claim 4 is drawn to a model which is math. In a BRI, each recited instance of a "model" reads on data and/or mathematical formulas in at least some embodiments.
Claim 5 depends from and further limit claim 4. Claim 5 recites five subtypes for the typing model recited in claim 4. Therefore, individually and as a whole, claim 5 is drawn to models of math.
Claim 6 depends from and further limit claim 4. Claim 6 recites and explains two mathematical calculations required for the typing model of claim 4:
the total expressed quantity of a said imprinted gene = (b+c+d)/(a+b+c+d)x100%; and
the expressed quantity of the imprinted gene with a copy number variation = d/(b+c+d) x100%;
Therefore, claim 6 is drawn to a model of math explicitly.
Claim 7 recites the following abstract ideas:
(2) Calculating a total expressed quantity of the imprinted gene Peg10, Dcn, Snrpn/Snurf, or Trappc9 in each said sample and an expressed quantity of the imprinted gene Peg10, Dcn, Snrpn/Snurf, or Trappc9 with a copy number variation in each said sample according to formulas with which to calculate said expressed quantities (Claim 7).
This step recites a mathematical calculation according to a formula. Hence this step equates to an abstract idea of mathematical concepts.
Calculating a product of each said total expressed quantity and a corresponding said expressed quantity corresponding to a copy number variation (Claim 7).
This step recites a mathematical calculation of a product of two parameters. Hence this step equates to an abstract idea of mathematical concepts.
(3) Performing a difference analysis, by way of Student's t-test, on the products of the total expressed quantities of the imprinted gene and the expressed quantities of the imprinted gene with a copy number variation so as to create the typing model (Claim 7).
This step recites a mathematical calculation according to an algorithm (Student’s t-test). Hence this step equates to an abstract idea of mathematical concepts.
Claim 8 further describes the samples and numbers of claim 7. There are no active steps recited in claim 8.
Step 2A Prong Two: Consideration of Practical Application
The claims result in a process of difference analysis, by way of Student's t-test, on the products of the total expressed quantities of the imprinted gene and the expressed quantities of the imprinted gene with a copy number variation so as to create the typing model. The claims do not recite any additional elements that integrate the abstract idea/judicial exception into a practical application. The identified additional elements are drawn to insignificant extra-solution activities as they are necessary to acquire data to conduct abstract ideas.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception.
Step 2B: Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea. The recited additional elements are drawn to:
(1) performing in-situ hybridization on samples with known five-year survival rate information, using a probe for the imprinted gene Dcn, of the imprinted gene Peg 10, of (the) imprinted gene Snrpn/Snurf, or of the imprinted gene Trappc9 (claim 7); and
(2) counting a, b, c, and d under a microscope (claim 7).
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the above identified additional elements are routine and conventional to perform the acts of in-situ hybridization on samples with probes, and count numbers under a microscope. The courts have recognized a similar laboratory technique as well-understood, routine, conventional activity in the life science arts when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity:
i. Determining the level of a biomarker in blood by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017);
viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
Viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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.
Claim(s) 1 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shi et al. ("Decorin is responsible for progression of non-small-cell lung cancer by promoting cell proliferation and metastasis." Tumor Biology 36 (2015): 3345-3354. Newly cited), and evidenced by Gu et al. ("Differential expression of decorin, EGFR and cyclin D1 during mammary gland carcinogenesis in TA2 mice with spontaneous breast cancer." Journal of Experimental & Clinical Cancer Research 29.1 (2010): 6. Newly cited).
Claim 1 is directed to a marker comprising the imprinted Dcn gene and claim 4 is directed to a prognostic typing model for lung cancer using the marker. Regarding claims 1 and 4, Shi provides (emphasis provided) “by quantitative reverse-transcriptase polymerase chain reaction (qRT-PCR) and Western blot. Also, the relationship between decorin and the NSCLC patients’ clinical characteristics or survival was analyzed. Via ectopic expression analyses and Western blot, the roles of decorin in proliferation, metastasis, and the underline mechanism for decorin expression were further explored. We found that decorin was downregulated in NSCLC tissues compared with the adjacent normal lung tissues or normal tissues. Additionally, the expression of decorin was correlated with tumor size, lymph node metastasis, tumor stage, and prognosis. We also showed that overexpression of decorin could inhibit NSCLC cell lines proliferation and metastasis. Through Western blot analysis, we identified that E-cadherin and vascular endothelial growth factor (VEGF) are two key factors responsible for the growth arrest and metastasis inhibition induced by decorin in NSCLC. Our results indicated that decorin plays crucial roles in NSCLC against carcinogenesis and progression. Decorin might be a predictive factor and an attractive therapeutic target for NSCLC patients” (page 3345, col 2, 1st para), which teaches that Decorin can be a prognostic marker for lung cancer.
However, Shi does not describe that Dcn is an imprinted gene. Whether a gene is an imprinted gene or not, is an inherent character of the gene. As long as Shi used the Dcn gene, even Shi does not explicitly claim, the Dcn gene is imprinted. The “imprinting” character of the Dcn gene is evidenced by Gu, Gu provides “Several imprinted genes, oncogenes and tumor suppressor genes were differentially expressed between normal mammary gland tissues and breast cancer tissues of TA2 mice. The imprinted gene decorin and the oncogene EGFR were down-regulated in tumor tissues, while the oncogene cyclin D1 was up-regulated” (page 1, Section “Abstract”/“Results” lines 1-3), which reveals the Dcn (decorin) gene is inherently an imprinted gene.
Free-of-Art Analysis
Claims 5-8 are art-free because the specific method to count genetic imprinting in the Dcn (Decorin), Peg10, Snrpn/Snurf, and/or Trappc9 gene in lung cancer and prognostic typing models based upon.
Most reference related to the Dcn gene describe the Dcn gene as a tumor suppressor. The higher Dcn expression is indicative of good prognosis for cancers and higher ratio of inactivation of the Dcn gene is associated with bad prognosis. Instant claims do not contradict with this doctoring regarding the Dcn expression, but they don’t affirm this doctoring explicitly either. Instead, the instant claims rely on the initial counts the cell ratio with the copy number variation (CNV) of these imprinted genes. Because the product of
the total expressed quantity of a said imprinted gene = (b+c+d)/(a+b+c+d)x100%; and
the expressed quantity of the imprinted gene with a copy number variation = d/(b+c+d) x100%;
equals to d/(a+b+c+d)x100% (a, b, c and d are defined in claim 6).
Art does not teach establishing imprinted cell ratio by hematoxylin staining and counting the red/brown spots in the nuclei.
Hence, the practice of counting a, b, c, and d in claim 5 for imprinted genes Dcn, Peg10, Snrpn/Snurf, and Trappc9 is not taught in art.
Hence, the practice of counting a, b, c, and d in claims 7 and 8 for imprinted genes Dcn, Peg10, Snrpn/Snurf, or Trappc9 (wherein a, b, c and d have been defined in claim 6) is not taught in art.
For the above reason, the instant claims 5-8 are free-of-art.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUOZHEN LIU whose telephone number is (571)272-0224. The examiner can normally be reached Monday-Friday 8-5.
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/GL/
Patent Examiner
Art Unit 1686
/Anna Skibinsky/
Primary Examiner, AU 1635