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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 7-15, in the reply filed on 10/7/2025 is acknowledged.
Claims 1-6 are withdrawn from consideration as being directed to non-elected claims.
Claim Objections
Claims 12-15 are objected to because of the following informalities: the claims appear to contain a typographical error in reciting “LINCO1798” instead of “LINC01798”. Appropriate correction is required.
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 10-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims simply recite the term “use” without providing any active steps. Accordingly, the claims do not fall within at least one of the four categories of patent eligible subject matter.
Claims 7-9 and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation/law of nature and an abstract idea without significantly more. This judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
35 U.S.C. § 101 requires that to be patent-eligible, an invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. M.P.E.P. § 2106. Regarding judicial exceptions, “[p]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972); see also M.P.E.P. § 2106. The unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, 561 U.S. 593, 601 (June 28, 2010) and Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). See also Myriad v Ambry, CAFC 2014-1361, -1366, December 17, 2014. The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66, 71 (2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Dia-mond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. at 601 (2010).
Claims Analysis:
As set forth in MPEP 2106, the claims have been analyzed to determine whether they are directed to one of the four statutory categories (STEP 1).
The instant claims are directed to methods and therefore are directed to one of the four statutory categories of invention.
The claims are then analyzed to determine if they recite a judicial exception (JE) (STEP 2A, prong 1) [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)].
The claimed invention recites a method of diagnosing colorectal cancer, rectal cancer, or colorectal adenoma by measuring the methylation level of the CpG region of the LINC01798 gene. This recitation is a natural correlation between the level of CpG methylation of LINC01798 and colorectal cancer, rectal cancer, or colorectal adenoma. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claims also recites steps or elements such as: “comparing” the measuring methylation levels, “providing information for the diagnosis”, “determining whether colorectal cancer, rectal cancer, or colorectal adenoma is present”. However these are considered a recitation of abstract ideas because they encompasses conclusions and determinations which can occur entirely within the mind. It is therefore determined that the claims are directed to judicial exceptions.
The claims are then analyzed to determine whether they recite an element or step that integrates the JE into a practical application (STEP 2A, prong 2) [Vanda Pharmaceuticals Inc., v. West-Ward Pharmaceuticals, 887 F.3d 1117 (Fed. Cir. 2018)].
The claims recite steps of measuring methylation levels, however this does not integrate the JE into a practical application because it is a mere data gathering step to use the correlation and does not add a meaningful limitation to the method.
In the absence of steps or elements that integrate the JE into a practical application, the additional elements/steps are considered to determine whether they add significantly more to the JE either individually or as an ordered combination, to “’transform the nature of the claim’ into a patent eligible application” [Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012), Alice Corp. Pry. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347 (2014)] (STEP 2B).
In the instant situation, the steps of measuring CpG methylation levels, including by “PCR”, “pyrosequencing”, “bisulfite sequencing”, or any of the other assays listed in claims 8 and 14, are generally recited and do not provide any particular reagents that might be considered elements that transform the nature of the claims into a patent eligible application because no specific elements/steps are recited. This step is not only a mere data gathering step, but the general recitation of detection of known nucleic acids is well understood, routine, and conventional activity (See MPEP 2106.05(d)(II)). Applicant is reminded that in Mayo, the Court found that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Further "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”. Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by’ . . . adding ‘insignificant post-solution activity’” (quoting Diehr, supra, at 191–192)). The Court also summarized their holding by stating “[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Therefore these limitations/steps do not “‘transform the nature of the claim’ into a patent-eligible application.’” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297).
When viewed as an ordered combination, the claimed limitations are directed to nothing more than the determination that a natural correlation/phenomena exists. Any additional element consists of using well understood, routine and conventional activity, and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.
Accordingly, it is determined that the instant claims are not directed to patent eligible subject matter.
Claim Rejections - 35 USC § 112
112(b)
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.
Claims 7-15 rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
The claims recite “the CpG region of the LINC01798 gene”, however this lacks sufficient antecedent basis because it is not clear which “CpG region” is being referred to. For example, the GWAS Catalog (ebi.ac.uk/gwas) teaches that the coordinates result in a 431kb gene which would be expected to contain more than one “CpG region”. Accordingly, the metes and bounds of the claim are unclear.
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Claim 10 recites a “use of an agent” for measuring the methylation level of a CpG region of the LINC01798 gene for manufacturing a preparation for diagnosing…”, however the claim does not provide any active steps. It is not clear if the claim is directed to measuring methylation levels or to manufacturing a reagent for detecting methylation.
The recitation of “primers specific for unmethylated regions” is confusing because it is not clear what unmethylated regions are being referred to. Do they refer to unmethylated regions of the LINC01798 gene or to any unmethylated sequence.
Claim 13 recites “determining whether… cancer … is present based on the measuring methylation level”, however the term “based on” is vague. The relationship between the methylation levels and diagnosis is not made clear by the recitation of “based on”. Additionally, the measurement of “levels” is a relative value that is unclear without a reference by which to compare it.
Claim Rejections - 35 USC § 102
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 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li (Li et al; Journal of Cellular Biochemistry; DOI:10.1002/jcb.29463, pages 1-10; January 13, 2020).
It is noted that claims 10-12 are directed to the use of an agent however they do not recite any positive active steps. Accordingly, the claims have been given their broadest reasonable interpretation to encompass methods that use an agent to detecting CpG methylation. Li teaches using the HM450K methylation microarray (agent) for CpG methylation analysis. Therefore, the teachings of Li are taken to anticipate the claims.
Conclusion
Li (Li et al; Journal of Cellular Biochemistry; DOI:10.1002/jcb.29463, pages 1-10; January 13, 2020). Li teaches a study that analyzed the DNA methylation of lncRNAs in colon adenocarcinoma. Li teaches identifying 105 lncRNAs whose expression was upregulated and 116 lncRNAs whose expression was downregulated in patients with colon adenocarcinoma compared to normal tissue controls, as well as CpG methylation analysis of 70 upregulated lncRNAs. However, with regard to claims 7-9 and 13-15, none of the differentially regulated lncRNAs (either upregulated or downregulated) or differentially methylated lncRNAs identified by Li were LINC01798.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to examiner Jehanne Sitton whose telephone number is (571) 272-0752. The examiner is a hoteling examiner and can normally be reached Mondays-Fridays from 8:00 AM to 2:00 PM Eastern Time Zone.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682