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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/3/2026 has been entered.
Claims 1, 3, 4, 8, 11, 13, 16, 17, 24-29, 41, 50, and 65-67 are pending.
Claims 1 and 65-67 remain withdrawn.
Claim 3 has been amended by Applicant.
Claims 3, 4, 8, 11, 13, 16, 17, 24-29, 41, and 50 are currently under examination.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Rejections Maintained
Claim Rejections - 35 USC § 101
Claims 3, 4, 8, 11, 13, 16, 17, 24-29, 41, and 50 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. As stated in the 2019 PEG, abstract ideas include mathematical concepts (including mathematical relationships, formulas, equations, and calculations), mental processes (including concepts performed in the human mind), and certain methods of organizing human activity (including managing personal behavior, relationships, or interactions between people). The rationale for this determination is explained below:
Claims 3, 4, 8, 11, 13, 16, 17, 24-29, 41, and 50 are directed to abstract ideas and natural phenomenon because the claims recite abstract ideas and natural phenomenon (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “abstract ideas” include the “comparing” step (a mental process) and the possible “adopting” step (a mental processes and/or a method of organizing human activity) of claim 26. The “natural phenomenon” include: amounts of megakaryocytes correlate with prognosis of cancer; amounts of circulating tumor cells correlate with prognosis; differences between amounts of CTCs and megakaryocytes correlate with prognosis; amounts of CTCs and megakaryocytes mathematically correlate with prognosis; and the presence of genomic alterations confirm malignancy of CTCs. In regards to administering recited therapeutic agent(s) and/or a therapeutic regime when the subject is identified as having a poor prognosis (see claim 3), the claims broadly encompass embodiments wherein administering a therapeutic agent/or a therapeutic regime are not required (see “when” in claim 3). In such embodiments, recited judicial exceptions are clearly not applied. In regards to embodiments requiring administration of a treatment or treatment regimen, MPEP 2106.04(d)(2) indicates a claim reciting a judicial exception is not directed to a judicial exception if it also recites additional elements(s) demonstrating the claim as a whole integrates the exception into a practical application by using recited judicial exceptions to effect a particular treatment or prophylaxis that has more than a nominal or insignificant relationship to the exception(s) (see aspirin example under “Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s)” at MPEP 2106.04(d)(2)). In the instant situation, there is not more than a “nominal or insignificant relationship” between a recited level of megakaryocytes indicative of a poor prognosis (judicial exception) and the optional (“when”) step of administering a therapeutic agent (such as an anti-androgen, a corticosteroid, oestrogen, or any chemotherapeutic agent) and/or therapeutic regime (such as hormone therapy, any chemotherapy, radiotherapy, any immunotherapy) encompassed by the claims to a subject with cancer having a level of megakaryocytes indicative of a poor prognosis. It has not been shown that high levels of megakaryocytes in a subject with cancer indicates that said subject will respond particularly well to each recited therapy and each recited therapeutic regime encompassed by the claims, as compared to cancer patients that have not been shown to have elevated levels of megakaryocytes.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (when considered both individually and as an ordered combination) are limited to requiring well-understood, routine and conventional limitations of measuring amounts of megakaryocytes in a blood sample, wherein the megakaryocytes are optionally enriched in the sample, wherein amounts of CTCs are optionally measured, and wherein genomic alterations in megakaryocytes or CTCs are measured (“Step 2B”). Well-understood, routine and conventional limitations are not meaningful limitations and are not enough to qualify the claimed method as reciting something “significantly more” than the judicial exception(s) (see Part I.B.1 of the interim Guidance).
Recited measuring and enriching steps are well-known, conventional, and routine in the art:
see page 721 and Table 1 of Kaufman et al (Blood, 1965, 26(6): 720-730; 10/3/24 IDS) teaching enriching megakaryocytes in a blood sample and measuring the amounts of enriched megakaryocytes;
see Table 1 of Scheinin et al (Blood, 1963, 22(1): 82-87; 10/3/24 IDS) teaching measuring the amounts of megakaryocytes in blood samples;
see Ozkumur et al (Science Translational Medicine, 2013, 179(5): 179ra47; 11 pages; 10/3/24 IDS) teaching enriching megakaryocytes and CTCs in blood samples from cancer patients, measuring the amounts of enriched CTCs and detecting enriched megakaryocytes (Figure 6, in particular);
see Leversha et al (Clin Cancer Res, 2009, 15(16): 2091-2097; 10/3/24 IDS) teaching enriching megakaryocytes and CTCs in blood samples from castration-resistant metastatic prostate cancer patients (many of which have been treated with chemotherapy and/or radiation – see right column on page 2096), measuring the amounts of enriched CTCs and detecting enriched megakaryocytes, measuring PSA concentration in samples from the patients, and measuring genomic alterations in megakaryocytes and CTCs by FISH (page 2092 and Figures 2-3, in particular); and
see right column on page 112 of Hume et al (NEJM, 1964, 270(3): 111-117; 10/3/24 IDS) teaching enriching and measuring CTCs and megakaryocytes in blood from subjects with various cancers.
The examiner further takes official notice that it is well-understood, routine and conventional to administer recited therapeutics and therapeutic regimes to subjects with cancer.
Further, MPEP 2106.05(d)(II) provides a non-limiting list of laboratory techniques recognized by courts as well-understood, routine, conventional activity. These techniques include:
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);
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v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
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Here, the claims do not contain any significant additional elements or steps beyond the observation of judicial exception(s) present when performing routine and conventional methods. Further, just as methods comprising detecting paternal DNA sequences in particular samples by PCR was identified in Ariosa v. Sequenom as "well-known, routine, and conventional" (see first paragraph on page 13 of Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015)) even though the prior art did not demonstrate detecting said paternal DNA sequences in said particular samples by PCR, the methods encompassed by the instant claims are well-known, routine, and conventional. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (common methods of detecting cells, proteins, and genetic alterations) and optionally administering a cancer treatment or treatment regime are routinely performed in the art to obtain data from subjects and therapeutically treat cancer patients. Moreover, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility…." Ariosa Diagnostics, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015), cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016). Further, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013). The claims do not recite something “significantly more” than the judicial exception(s); rather, the claims “simply inform” the natural phenomenon to one performing routine active method steps and do not amount to significantly more than the judicial exception(s). See the 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) (“the interim Guidance”).
Response to Arguments
In the Reply of 2/3/26, Applicant argues that the claims are patent eligible because the claims practically apply the judicial exceptions by requiring a recited therapeutic agent or therapeutic agent be administered to a subject identified as having a poor prognosis.
The amendments to the claims and the arguments found in the Reply of 2/3/26 have been carefully considered, but are not deemed persuasive. In regards to the argument that that the claims are patent eligible because the claims practically apply the judicial exceptions by requiring a recited therapeutic agent or therapeutic agent be administered to a subject identified as having a poor prognosis, claimed methods only require administering a therapeutic agent or a therapeutic regime “when” a subject is identified as having a poor prognosis. In instances when the subject is not identified as having a poor prognosis, recited therapeutics and therapeutic regimens are not required to be administered. In such embodiments, recited judicial exceptions are clearly not applied. In regards to embodiments requiring administration of a treatment or treatment regimen, MPEP 2106.04(d)(2) indicates a claim reciting a judicial exception is not directed to a judicial exception if it also recites additional elements(s) demonstrating the claim as a whole integrates the exception into a practical application by using recited judicial exceptions to effect a particular treatment or prophylaxis that has more than a nominal or insignificant relationship to the exception(s) (see aspirin example under “Whether The Limitation(s) Have More Than A Nominal Or Insignificant Relationship To The Exception(s)” at MPEP 2106.04(d)(2)). In the instant situation, there is not more than a “nominal or insignificant relationship” between a recited level of megakaryocytes indicative of a poor prognosis (judicial exception) and the optional (“when”) step of administering a therapeutic agent (such as an anti-androgen, a corticosteroid, oestrogen, or any chemotherapeutic agent) and/or therapeutic regime (such as hormone therapy, any chemotherapy, radiotherapy, any immunotherapy) encompassed by the claims to a subject with cancer having a level of megakaryocytes indicative of a poor prognosis. It has not been shown that high levels of megakaryocytes in a subject with cancer indicates that said subject will respond particularly well to each recited therapy and each recited therapeutic regime encompassed by the claims, as compared to cancer patients that have not been shown to have elevated levels of megakaryocytes.
Conclusion
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/SEAN E AEDER/Primary Examiner, Art Unit 1642