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 .
DETAILED ACTION
1. The Amendment filed July 10, 2026, in response to the Office Action of February 13, 2026, is acknowledged and has been entered. Claims 2-3 and 6 have been cancelled. Claims 1, 4, 5, and 7 have been amended. New claims 9-16 have been added.
2. Claims 1, 4, 5, and 7-16 are currently being examined.
New 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.
3. Claims 13-16 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 13 recites “(3) predicting that an antiplatelet agent can be selected for a patient assesses as being at risk of cancer-associated thrombosis.” It is unclear if this step is drawn to a patient assessing their risk of cancer-associated thrombosis or if the claim is drawn to predicting that an antiplatelet agent can be selected for a patient already assessed as being at risk of cancer-associated thrombosis. Thus, the claim is indefinite. Claims 14-16 incorporate by reference the limitations of claim 13 and thus are also indefinite.
Amendment of the claim to, e. g., “(3) predicting that an antiplatelet agent can be selected for a patient assessed as being at risk of cancer-associated thrombosis” would help to obviate the rejection.
Response to Arguments
4. Applicant argues that to the extent that the §112(b) rejection applies to newly added claim 13, the Applicant respectfully submits that claim 13 is definite because it clarifies that the objective is to predict whether or not an antiplatelet agent can be selected in a postoperative cancer patient. Furthermore, the language "a method for assessing a risk of cancer-associated thrombosis in a perioperative period of a cancer patient" is replaced with the steps described in original claims 2 and 3. In the method of new claim 10, the soluble CLEC2 concentration alone can be used as an index, or the combination of the soluble CLEC2 concentration with the platelet count (i.e., C2PAC value) can be used as the index. Additionally, the language "from preoperative period to 30 days postoperatively overtime" is deleted and "the cancer patient" in step (1) is amended to "the postoperative cancer patient."
Applicant argues that accordingly, the Applicant respectfully submits that newly added claim 13 is definite and requests that it be permitted to proceed to allowance.
Applicant’s arguments have been considered, but have not been found persuasive because step (3) is indefinite for the reasons set forth above.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 13-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection
Claim 13 is drawn a method for predicting whether or not an antiplatelet agent can be selected in a postoperative cancer patient, the method comprising: (1) providing a sample from the postoperative cancer patient; (2a) determining a concentration of soluble CLEC2 in the sample; correlating the concentration of soluble CLEC2 with a presence or absence of a cancer-associated thrombosis in the postoperative cancer patient, or with a likelihood of outcome to assess whether the postoperative cancer patient is at risk of a cancer-associated thrombosis based on a change in the concentration of soluble CLEC2; or (2b) determining a concentration of CLEC2 and a platelet count in the sample; calculating a C2PAC value by dividing the concentration of soluble CLEC2 by the platelet count; correlating the C2PAC value with a presence or absence of a cancer- associated thrombosis in the postoperative cancer patient, or with likelihood of outcome to assess whether the postoperative cancer patient is at risk of a cancer-associated thrombosis based on a change in the C2PAC value; and (3) predicting that an antiplatelet agent can be selected for a patient assesses as being at risk of cancer-associated thrombosis.
The specification and claims as filed teach:
1. A method for assessing a risk of cancer-associated thrombosis in a perioperative period of a cancer patient, comprising the step of measuring a concentration of soluble CLEC2 in blood collected from the cancer patient.
2. The method according to claim 1, comprising: (1) providing a sample from a patient who may have cancer-associated thrombosis, or a patient who has been diagnosed with cancer-associated thrombosis; (2) determining a concentration of soluble CLEC2 in the sample; and (3) correlating the soluble CLEC2 concentration with a presence or absence of cancer-associated thrombosis in the patient, or with likelihood of outcome.
3. The method according to claim 1, wherein the step of correlating the soluble CLEC2 concentration with a presence or absence of cancer-associated thrombosis in the patient, or with likelihood of outcome comprises a step of assessing whether the patient is at risk of cancer-associated thrombosis based on a change in the soluble CLEC2 concentration.
5. The method according to claim 1, wherein a value obtained by dividing the soluble CLEC2 concentration by a platelet count is used instead of the soluble CLEC2 concentration.
6. A method for predicting efficacy determination of an antiplatelet agent in a method for assessing a risk of cancer-associated thrombosis in a perioperative period of a cancer patient, by providing samples derived from the cancer patient from preoperative period to 30 days postoperatively over time, and monitoring risk assessment continuously.
However, these disclosed methods do not teach using step (2a) or (2b) for predicting whether or not an antiplatelet agent can be selected in a postoperative cancer patient. Thus claim 13 and its dependent claims are new matter.
Maintained/Modified 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.
6. Claims 13-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract, mental correlation of a natural law/phenomenon without significantly more without significantly more. The claims recite (2a) determining a concentration of soluble CLEC2 in the sample; correlating the concentration of soluble CLEC2 with a presence or absence of a cancer-associated thrombosis in the postoperative cancer patient, or with a likelihood of outcome to assess whether the postoperative cancer patient is at risk of a cancer-associated thrombosis based on a change in the concentration of soluble CLEC2; or (2b) determining a concentration of CLEC2 and a platelet count in the sample; calculating a C2PAC value by dividing the concentration of soluble CLEC2 by the platelet count; correlating the C2PAC value with a presence or absence of a cancer-associated thrombosis in the postoperative cancer patient, or with likelihood of outcome to assess whether the postoperative cancer patient is at risk of a cancer-associated thrombosis based on a change in the C2PAC value; and (3) predicting that an antiplatelet agent can be selected for a patient assesses as being at risk of cancer-associated thrombosis. This judicial exception is not integrated into a practical application because the claims generally link the natural soluble CLEC2 concentration with assessing a risk of cancer-associated thrombosis and selecting an antiplatelet agent based on the assessment. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because claims determine the level of soluble CLEC2 concentration as a high level of generality and that are well-understood, purely conventional or routine in art.
A claim that focuses on use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, and added something significant to, the natural principle itself. See Mayo, 101 USPQ2d at 1966. Patents cannot be obtained on subject matter identified by the courts as being exempted from eligibility (i.e., laws of nature, natural phenomenon, and abstract ideas).
The Mayo framework provides that first whether the claims at issue are directed to a patent-ineligible concept is determined. If the answer is yes, then the elements of each claim both individually and “as an ordered combination” are considered to determine whether additional elements “transform the nature of the claim” into a patent-eligible application. The second step—known as the “inventive concept”—requires that claims include elements which would render the method both new and useful.
The recent Eligibility Guidance (2014 Interim Guidance on Patent Subject Matter Eligibility (Interim Eligibility Guidance and 2018 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019) address the subject matter eligibility analysis for all claims (i.e., machine, composition of matter, manufacture and process claims). The analysis is to be used for evaluating whether a claim is drawn to patent-eligible subject matter.
Step 1 determines whether the claim is directed to a process, machine, manufacture, or composition of matter. If the claim is directed to a statutory category, proceed to Step 2.
Step 2 is the two-part analysis for claims directed to laws of nature, natural phenomena, and abstract ideas (the judicially recognized exceptions).
In Step 2A, determine whether the claim is directed to a law of nature, a natural phenomenon, or an abstract idea (judicial exceptions). “Directed to” means the exception is recited in the claim, i.e., the claim sets forth or describes the exception.
In Prong One of Step 2A it is determined if the claim recites a judicial exception. If the claim recites a judicial exception then Prong Two of Step 2A determines whether the claims recites additional elements that integrate the exception into a practical application.
If the answer to Prong Two of Step 2A is no, Step 2B is used to determine whether the claim as a whole amounts to significantly more than the exception by the recitation of additional elements.
The present claims are directed to processes so Step 1 is satisfied.
For Prong One of Step 2A the claims recite a judicial exception. In particular, the claims recite (2a) determining a concentration of soluble CLEC2 in the sample; correlating the concentration of soluble CLEC2 with a presence or absence of a cancer-associated thrombosis in the postoperative cancer patient, or with a likelihood of outcome to assess whether the postoperative cancer patient is at risk of a cancer-associated thrombosis based on a change in the concentration of soluble CLEC2; or (2b) determining a concentration of CLEC2 and a platelet count in the sample; calculating a C2PAC value by dividing the concentration of soluble CLEC2 by the platelet count; correlating the C2PAC value with a presence or absence of a cancer- associated thrombosis in the postoperative cancer patient, or with likelihood of outcome to assess whether the postoperative cancer patient is at risk of a cancer-associated thrombosis based on a change in the C2PAC value; and (3) predicting that an antiplatelet agent can be selected for a patient assesses as being at risk of cancer-associated thrombosis. This is an abstract, mental correlation of the soluble CLEC2 concentration with assessing a risk of cancer-associated thrombosis and selecting an antiplatelet agent based on the assessment. So, the answer to Prong One of Step 2A is yes the claims do recite a judicial exception.
For Prong Two of Step 2A the claims do not integrate the exception into a practical application. This judicial exception is not integrated into a practical application because the claims generally link the natural soluble CLEC2 concentration with assessing a risk of cancer-associated thrombosis and selecting an antiplatelet agent based on the assessment. Thus, the answer to Prong Two of Step 2A is no.
With respect to Step 2B MPEP 2106.05 (I) teaches that
While abstract ideas, natural phenomena, and laws of nature are not eligible for patenting by themselves, claims that integrate these exceptions into an inventive concept are thereby transformed into patent-eligible inventions. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1981 (2014) (citing Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). Thus, the second part of the Alice/Mayo test is often referred to as a search for an inventive concept. Id.
An inventive concept "cannot be furnished by the unpatentable law of nature (or natural
phenomenon or abstract idea) itself." Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016). See also Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 78, 101 USPQ2d at 1968 (after determining that a claim is directed to a judicial exception, "we then ask, ‘[w]hat else is there in the claims before us?") (emphasis added)); RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"). Instead, an "inventive concept" is furnished by an element or combination of elements that is recited in the claim in addition to (beyond) the judicial exception, and is sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception itself. Alice Corp., 134 S. Ct. at 2355, 110 USPQ2d at 1981 (citing Mayo, 566 U.S. at 72-73, 101 USPQ2d at 1966
With respect to Step 2B MPEP 2106.05 (d) teaches that:
Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry. If the additional element (or combination of elements) is a specific limitation other than what is well-understood, routine and conventional in the field, for instance because it is an unconventional step that confines the claim to a particular useful application of the judicial exception, then this consideration favors eligibility. If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility.
On the other hand, Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 67, 101 USPQ2d 1961, 1964 (2010) provides an example of additional elements that were not an inventive concept because they were merely well-understood, routine, conventional activity previously known to the industry, which were not by themselves sufficient to transform a judicial exception into a patent eligible invention. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 79-80, 101 USPQ2d 1969 (2012) (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 199 (1978) (the additional elements were "well known" and, thus, did not amount to a patentable application of the mathematical formula)). In Mayo, the claims at issue recited naturally occurring correlations (the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that a drug dosage will be ineffective or induce harmful side effects) along with additional elements including telling a doctor to measure thiopurine metabolite levels in the blood using any known process. 566 U.S. at 77-79, 101 USPQ2d at 1967-68. The Court found this additional step of measuring metabolite levels to be well-understood, routine, conventional activity already engaged in by the scientific community because scientists "routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds." 566 U.S. at 79, 101 USPQ2d at 1968. Even when considered in combination with the other additional elements, the step of measuring metabolite levels did not amount to an inventive concept, and thus the claims in Mayo were not eligible. 566 U.S. at 79-80, 101 USPQ2d at 1968-69.
Additionally MPEP 2106.05 (d) II teaches that:
The courts have recognized the following laboratory techniques 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);
ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
iii. Detecting DNA or enzymes in a sample, Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088 (Fed. Cir. 2017);
iv. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011);
v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
vi. Freezing and thawing cells, Rapid Litig. Mgmt. 827 F.3d at 1051, 119 USPQ2d at 1375;
vii. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014); and
viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
With respect to the instant claims the claims perform well-understood, routine, conventional activity of determining the concentration of soluble CLEC2 in blood or providing samples from cancer patients at high level of generality and the Federal Circuit court has determined this to be well-understood, routine, and conventional activity. Additionally, Kazama et al. (Platelets 2015 26(8): 711-719, of record) teaches routinely determining the levels of soluble CLEC2 in blood. See abstract and Figures 1-6.
Thus, given the above, the instant claims do not "practically apply" the naturally occurring phenomena of the concentration of soluble CLEC2 and its correlation with the risk of cancer associated thrombosis and selecting an antiplatelet agent based on the assessment; rather, the claims "simply inform" to one performing routine active method steps of the phenomena of soluble CLEC2 in the blood and its correlation with the cancer associated thrombosis. The claims do not amount to significantly more than the abstract correlation of a natural phenomenon and thus, as a whole, the claims do not recite something significantly different than a judicial exception(s) and are not patent eligible.
Response to Arguments
7. Applicant argues that amended claim 1 requires, inter alia, a step of administering an effective amount of an antiplatelet agent to a patient assessed as being at risk of the cancer-associated thrombosis. In other words, amended claim 1 practically applies the naturally occurring phenomena of the concentration of soluble CLEC2 and its correlation with the risk of cancer-associated thrombosis. Therefore, amended claim 1 amounts to "significantly more" than the abstract correlation of natural phenomena.
The Applicant respectfully submits that claim 1, as amended above, amounts to "significantly more" than the abstract correlation of natural phenomena, and requests the §101 rejection of claim 1, and all claims depending therefrom, be withdrawn.
Additionally, the Applicant respectfully submits that each of independent claims 5 and 13 also amount "significantly more" than the abstract correlation of natural phenomena, and requests the §101 rejections of claims 5 and 13, and all claims depending therefrom, be withdrawn.
8. Applicant's arguments have been considered, but have not been found persuasive because claims 13-16 do not recite a step of administering an effective amount of an antiplatelet agent to a patient assessed as being at risk of a cancer-associated thrombosis. Thus, the claims do not amount to significantly more than the abstract correlation of a natural phenomenon and thus, as a whole, the claims do not recite something significantly different than a judicial exception(s) and are not patent eligible for the reasons previously set forth and above.
Conclusion
9. All other objections and rejections recited in the Office Action of February 13, 2026, are withdrawn in view of Applicant’s amendments and arguments.
10. Claims 13-16 are rejected. Claims 1, 4, 5, and 7-12 are allowed.
10. No claims allowed.
11. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER J REDDIG whose telephone number is (571)272-9031. The examiner can normally be reached on M-F 8:30-5:30 Eastern Time
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/Peter J Reddig/
Primary Examiner, Art Unit 1646
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