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 .
Claims 1-26 are currently pending and under examination.
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 1-26 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 detecting a cancer or tumor in a subject by determining the concentration of cfDNA and generating a model on subjects with cancer and determining the concentration of cfDNA and generating a model on subjects without cancer. This recitation is a natural correlation between the concentration of cfDNA and cancer diagnosis. With regard to the natural correlation, as in Mayo, the relationship is itself a natural process that exists apart from any human action. The claimed invention also recites “determining a concentration”, “generating a model”, “determining the presence of cancer”, “comparison of the first and second model”, obtaining an “optimized threshold”, “classifying” concentrations as low, moderate, and high, etc, which are recitations of abstract ideas because they encompass mathematical formulas and calculations, reading reports, making mental comparisons, and otherwise performing abstract mental activity that requires no more than pencil and paper. 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 obtaining biological sample and isolating cfDNA, however this does not integrate the JE into a practical application because it is a mere data gathering step and does not add a meaningful limitation to the method. Dependent claims directed to use of electrophoresis or PCR, etc, or a genomic cancer screening assay are also mere data gathering. The additional elements recited are all directed to abstract ideas or merely recite the natural correlation and therefore do not integrate the JE’s into a practical application because they are JE’s themselves.
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 step of obtaining a sample is considered insignificant post solution activity. The steps of isolating cfDNA, determining concentrations, and performing a genomic screening assay 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. These steps are not only mere data gathering, 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 § 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 1, 2, 4, 5, 8-15, 17, 18, and 21-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (Kim et al; Frontiers in Veterinary Science; September 2021, volume 8, pages 1-8; cited in the IDS filed 2/20/2025) .
Kim method of detecting cancer (lymphoma, hepatocellular carcinoma, thyroid hemangiosarcoma, mammary carcinoma, adenocarcinoma, and mast cell tumor; see page 4, col 1) in dogs by determining the concentration of cfDNA in plasma obtained from the animals (page 1-2). Kim teaches collecting blood samples, storing supernatant following centrifugation of plasma to obtain optimal cell free plasma (page 2, col 2). With regard to claims 1, 2, 14, and 15, this is considered to teach isolating cfDNA and extracting the cfDNA, as well as obtaining a plasma sample and determining the concentration of cfDNA directly from the sample since the supernatant is plasma. With regard to claims 4 and 17, Kim teaches using a fluorometric assay for detecting cfDNA concentration in subjects with cancer and subjects without cancer. In analysis of the cfDNA concentrations in both subjects with cancer and without cancer, including the use of statistical models (see pages 2-3), Kim inherently teaches generating a first and second experimental model. Kim teaches comparing data and results for both subjects with and without carcinoma (see pages 3-7; determination of a distribution of cfDNA concentrations in healthy controls and cancerous patients and a comparison of the values with these distributions). With regard to claims 5 and 18, Kim teaches obtaining optimized thresholds (pages 3-6). With regard to claims 8-13 and 21-26, Kim teaches different demographic variables, including age and gender, in dogs (mammal, canine) (see whole document, page 4).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 8-18, and 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Jeon (Jeon et al; Laboratory Medicine and Quality Assurance, vol 41, 2019, pages 214-219).
Kim method of detecting cancer (lymphoma, hepatocellular carcinoma, thyroid hemangiosarcoma, mammary carcinoma, adenocarcinoma, and mast cell tumor; see page 4, col 1) in dogs by determining the concentration of cfDNA in plasma obtained from the animals (page 1-2). Kim teaches collecting blood samples, storing supernatant following centrifugation of plasma to obtain optimal cell free plasma (page 2, col 2). Kim teaches isolating cfDNA and extracting the cfDNA, as well as obtaining a plasma sample and determining the concentration of cfDNA directly from the sample since the supernatant is plasma. Kim teaches using a fluorometric assay for detecting cfDNA concentration in subjects with cancer and subjects without cancer. In analysis of the cfDNA concentrations in both subjects with cancer and without cancer, including the use of statistical models (see pages 2-3), Kim necessarily teaches generating a first and second experimental model. Kim teaches comparing data and results for both subjects with and without carcinoma (see pages 3-7; determination of a distribution of cfDNA concentrations in healthy controls and cancerous patients and a comparison of the values with these distributions). Kim teaches obtaining optimized thresholds (pages 3-6). Kim teaches different demographic variables, including age and gender, in dogs (mammal, canine) (see whole document, page 4).
With regard to claims 3 and 16, Kim does not teach using electrophoresis for cfDNA measurement, however Jeon teaches analysis of different methods of quantifying cfDNA and teaches that electrophoresis allows for additional determination of the size distribution of DNA fragments (see abstract, whole document). Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to have included analysis via electrophoresis as taught by Jeon, in the method of cfDNA quantification of Kim because Jeon teaches that it also allows for determination of size distribution of DNA fragments.
Claims 1, 2, 4-15, and 17-26 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Koumbaris (Koumbaris et al; WO2022/129370).
Kim method of detecting cancer (lymphoma, hepatocellular carcinoma, thyroid hemangiosarcoma, mammary carcinoma, adenocarcinoma, and mast cell tumor; see page 4, col 1) in dogs by determining the concentration of cfDNA in plasma obtained from the animals (page 1-2). Kim teaches collecting blood samples, storing supernatant following centrifugation of plasma to obtain optimal cell free plasma (page 2, col 2). Kim teaches isolating cfDNA and extracting the cfDNA, as well as obtaining a plasma sample and determining the concentration of cfDNA directly from the sample since the supernatant is plasma. Kim teaches using a fluorometric assay for detecting cfDNA concentration in subjects with cancer and subjects without cancer. In analysis of the cfDNA concentrations in both subjects with cancer and without cancer, including the use of statistical models (see pages 2-3), Kim necessarily teaches generating a first and second experimental model. Kim teaches comparing data and results for both subjects with and without carcinoma (see pages 3-7; determination of a distribution of cfDNA concentrations in healthy controls and cancerous patients and a comparison of the values with these distributions). Kim teaches obtaining optimized thresholds (pages 3-6). Kim teaches different demographic variables, including age and gender, in dogs (mammal, canine) (see whole document, page 4).
Kim does not teach classifying concentration into low, moderate, and high category, however Koumbaris teaches classifying samples into clinically relevant categories in quantification of cfDNA (see whole document). Koumbaris teaches data analysis including calculating scores, (see whole document), as well as classification of samples as low, medium and high depending on the score for cfDNA (see for example claim 5 of Koumbaris). Therefore, it would have been prima facie obvious to the ordinary artisan prior to the effective filing date to have included analysis as taught by Koumbaris in the method of Kim for the benefit of obtaining clinically relevant categories for diagnostic purposes.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Winston Shen, can be reached on (571) 272-3157. The fax phone number for organization where this application or proceeding is assigned is (571) 273-8300.
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/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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