DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Applicant's response, filed on 07/23/2025, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of claims
Canceled:
1-27
Pending:
28-30
Amended:
28
Withdrawn:
none
Examined:
28-30
Independent:
28
Allowable:
none
Priority
As detailed on the 04/14/2017 filing receipt, this application claims priority to as early as 10/08/2014.
Drawings
The drawings filed 04/05/2017 are accepted.
Withdrawn Rejections/Objections
The rejection of claims 28-30 under 35 U.S.C. §112(a), in the Office action mailed 04/23/2025 is withdrawn in view of the amendments filed 07/23/2025.
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 28-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1). In the instant application, the claims recite the following limitations that equate to an abstract idea:
Mental processes recited include:
Claim 28 recites: "measuring concentration values of Thr and Arg in a blood sample of a subject..." and "...a sum of the measured concentration values of Thr and Arg smaller than a respective predetermined value..." are acts of evaluating, analyzing and judging data that could be practically performed in the human mind and/or with pen and paper.
Claim 30 recites: "searching for a substance effectively ameliorating a risk of arrhythmia from a suitable combination of a drug, amino acid, food and supplement." Searching is an act of evaluating, analyzing and judging data that could be practically performed in the human mind and/or with pen and paper.
Mathematical concepts recited include:
Claim 28 recites: "sum of the measured concentration values of Thr and Arg smaller than a respective predetermined value." The process of summing requires carrying out a series of mathematical calculations.
Law of Nature recited include:
Claim 28 recites "... identifying the subject having the measured concentration value of Thr or a sum of the measured concentration values of Thr and Arg smaller than a respective predetermined value as having a risk of arrhythmia..." The claim element recites a correlation between the level of Thr or sum of Thr and Arg concentration in blood and the risk of having arrhythmia, which is a law of nature because it describes a consequence of natural processes in the human body, e.g., the naturally-occurring relationship between Thr or sum of Thr and Arg concentration in blood and the risk of having arrhythmia.
Certain methods of organizing human activity recited include:
Claim 28 recites: “performing a treatment on the identified subject for the risk of arrhythmia.” The process of performing a treatment is involved with providing rules or instructions to be followed.
Claim 29 recites: "providing the subject with a suggestion for reducing a risk of arrhythmia." The process of providing the subject with a suggestion is involved with providing rules or instructions to be followed.
The processes of claim 28 includes measuring concentration values of Thr and Arg, which is involved with acts of evaluating, analyzing and judging data in order to determine the concentration of Thr and Arg. Claim 28 also includes a process of comparing the measured concentration values of Thr and Arg with a predetermined value to determine the smaller value and the sum of the measured concentration values of Thr and Arg involves adding values, which are acts of evaluating, analyzing and judging data that could be accomplished by the human mind and/or with pen and paper. Claim 30 is involved with searching for a substance that could be accomplished by reviewing, evaluating and analyzing a list of substances, which are mental processes. Acts of evaluating and analyzing data could be practically performed in the human mind and/or with pen and paper because they merely require making observations, evaluations, judgments, and opinions (See MPEP 2106.04(a)(2) subsection III). Therefore, under the broadest reasonable interpretation, claims 28 and 30 can be practically carried out in the human mind or with pen and paper as claimed, which falls under the "Mental processes" grouping of abstract ideas.
Claim 28 recites mathematical concepts and formulas as discussed above. The sum of the measured concentration values of Thr and Arg requires carrying out a series of mathematical calculations of adding values. Therefore, claim 28 recites claim elements that falls under the “mathematical concepts” grouping of abstract ideas.
Claim 28 recites a law of nature as discussed above. The claim element recites a correlation between the level of Thr or sum of Thr and Arg concentration in blood and the risk of having arrhythmia, which is a law of nature.
The limitation of claim 29 is involved with a process of providing the subject with a suggestion which is providing rules or instructions to be followed that falls under the abstract idea of "certain methods of organizing human activity."
As such, claims 28-30 recite an abstract idea (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). The above indicated judicial exceptions are not integrated into a practical application because the claims do not recite an additional elements that apply, rely on or use the judicial exception in such a manner to amount to integration into a practical application. For example, there are no limitations that reflect an improvement to technology or applies or uses the recited judicial exception in some other meaningful way. Rather, the instant claims recite additional elements that equate to mere instructions to implement an abstract idea or insignificant extra solution activity. Specifically, the instant claims recite the following additional elements:
Claim 28 recites: "measuring concentration values of Thr and Arg in a blood sample of a subject... performing a treatment..."
Claim 29 recites: "providing the subject with a suggestion for reducing a risk of arrhythmia."
The elements of claim 28 of measuring concentration of Thr and Arg equate to insignificant extra solutional activities of data gathering. Data gathering serves as input to the recited judicial exception in the claims. The listed additional elements are mere instructions to apply an exception because they recite no more than an idea of a solution or outcome and does not recite a technological solution to a technological problem. (See MPEP 2106.05(f)(1)). The limitations of claim 28 of performing a treatment and the limitation of claim 29 of providing the subject with a suggestion for reducing a risk of arrhythmia applies the exception in a generic way and does not integrate the recited exception into a practical application (see MPEP 2106.04(d)(2)). As such, as currently recited, the claims do not appear to recite an improvement to technology or apply or use the recited judicial exception in some other meaningful way. Therefore, claims 28-30 are directed to an abstract idea (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that equate to well-understood, routine and conventional activities, insignificant extra-solution activity or mere instructions to implement the abstract idea on a generic computer. The instant claims recite the following additional elements:
Claim 28 recites: "measuring concentration values of Thr and Arg in a blood sample of a subject... performing a treatment..."
Claim 29 recites: "providing the subject with a suggestion for reducing a risk of arrhythmia."
The additional elements indicated above do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. The limitation of measuring concentration values of Thr and Arg in a blood sample of a subject equate to mere data gathering activities. The courts have recognized that techniques for determining the level of a biomarker in blood by any means 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. (See MPEP 2106.05(d)). The limitation of claim 28 of performing a treatment and the limitation of claim 29 for providing the subject with a suggestion for reducing a risk of arrhythmia equates to mere instructions to apply the judicial exception in a generic way. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims (Also see MPEP 2106.04(d)(2)). Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, claims 28-30 are not patent eligible.
Response to 35 USC § 101 Arguments
Applicant's arguments filed 07/23/2025 have been fully considered as discussed below.
Applicant amended claim 28.
Applicant states that the revised claim set obviates the claim rejections under 35 U.S.C. § 101.
In response, Applicants' remarks and amendments have been fully considered and does not obviate the claim rejections under 35 U.S.C. § 101. Amended claim 28 recites the limitation of “…identifying the subject having the measured concentration value of Thr or a sum of the measured concentration values of Thr and Arg smaller than a respective predetermined value as having a risk of arrhythmia, and performing a treatment on the identified subject for the risk of arrhythmia.” Performing a treatment on the identified subject is not particular because the treatment is not specifically identified so that it does not encompass all applications of the judicial exception(s). The performing a treatment step is merely instructions to "apply" the exception in a generic way. Thus, the performing a treatment step does not integrate the JEs into a practical application under Step 2A, Second Prong, 2nd consideration of the 101 analysis. (See MPEP 2106.04(d)(2)).
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.
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hess ("Depression, Cardiovascular Disease and Amino Acids." (2014), published Spring 2014; as cited on the 04/23/2025 Notice of References 892 form).
Regarding independent claim 28, Hess teaches measuring concentration values of Thr and Arg in a blood sample of a subject and identifying the subject having the measured concentration value of Thr or a sum of the measured concentration values of Thr and Arg smaller than a respective predetermined value as having a risk of arrhythmia with "MD (major depression) has been associated with increased risk for cardiovascular disease (CVD) and conversely CVD has been associated with increased MD symptoms. Previous studies have shown that serum levels of nitric oxide (NO) were reduced in MD patients and in patients with CVD. We measured serum levels of arginine, the precursor amino acid of NO and found that they were reduced in MD subjects compared to healthy controls (HCs)." (Abstract). Hess also measures other amino acid levels in Table 4-1. Table 4-1 SERUM AMINO ACID LEVELS (Page 125) lists measured amino acid levels, including threonine for subjects with major depression (MD) and subjects that are healthy controls (HC).
Hess teaches performing a treatment on the identified subject for the risk of arrhythmia with "In cases where MD patients exhibit CVD and are at risk of MI (Myocardial Infarction), treatment with conventional antidepressants may decrease the severity of CVD symptoms and improve outcome." (Page 25, para. 3).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Hess ("Depression, Cardiovascular Disease and Amino Acids." (2014), published Spring 2014; as cited on the 04/23/2025 Notice of References 892 form) as applied to claim 28 above, in view of Eilat-Adar ("Nutritional recommendations for cardiovascular disease prevention." Nutrients 5.9 (2013): 3646-3683, published Feb. 21, 2013; cited on the 04/23/2025 Notice of References 892 form).
Hess is applied to claim 28 as discussed above.
Hess does not teach providing the subject with a suggestion for reducing a risk of arrhythmia of claim 29 and searching for a substance effectively ameliorating a risk of arrhythmia from a suitable combination of a drug, amino acid, food and supplement of claim 30. However, these limitations are taught by Eilat-Adar.
Regarding claim 29, Eilat-Adar teaches providing the subject with a suggestion for reducing a risk of arrhythmia with "This position paper, written by collaboration between the Israel Heart Association and the Israel Dietetic Association, summarizes the current, preferably latest, literature on the association of nutrition and CVD (Cardiovascular diseases) with emphasis on the level of evidence and practical recommendations. The nutritional information is divided into three main sections: dietary patterns, individual food items, and nutritional supplements." (Abstract). Eilat-Adar teaches recommendations for reducing cardiovascular diseases that includes arrhythmia.
Regarding claim 29, Eilat-Adar teaches searching for a substance effectively ameliorating a risk of arrhythmia from a suitable combination of a drug, amino acid, food and supplement with "We conducted a comprehensive literature search through electronic databases up to December 2012. We systematically searched published meta-analysis of intervention or cohort prospective studies that investigated the association between the relevant keywords of the chapter topic and cardiovascular health outcomes in electronic databases: The Cochrane Library (source: The Cochrane Central Register of Controlled Trials, Pubmed and Google Scholar. When multiple articles for a single study were present, we used the latest publication the most complete one. If needed, general historical information was added." (Page 3647, para. 2) and "This position paper, written by collaboration between the Israel Heart Association and the Israel Dietetic Association, summarizes the current, preferably latest, literature on the association of nutrition and CVD with emphasis on the level of evidence and practical recommendations. The nutritional information is divided into three main sections: dietary patterns, individual food items, and nutritional supplements." (Abstract). Eilat-Adar teaches cardiovascular diseases that includes arrhythmia.
It would have been prima facie obvious to combine the teachings of Hess and Eilat-Adar to arrive at the claimed invention. Eilat-Adar's teaching is directed towards the study of cardiac diseases and is in a similar field of endeavor as Hess. A person of ordinary skill in the art would have been motivated to combine the method of Hess with the method taught by Eilat-Adar to incorporate providing the subject with a suggestion and to search for a combination of substances for reducing the risk of heart disease, such as arrhythmia as described by Eilat-Adar. Eilat-Adar's method allows one to obtain a comprehensive understanding of the association between nutrition and CVD that would be advantageous for providing nutritional recommendations for reducing CVD risks.
Response to Arguments
Applicant's arguments filed 07/23/2025 have been fully considered as discussed below.
Response to 35 USC § 102 Arguments
Applicant amended claim 28.
Applicant argues that Hess does not teach or suggest "measuring concentration values of Thr and Arg in a blood sample of a subject; and identifying the subject having the measured concentration value of Thr or a sum of the measured concentration values of Thr and Arg smaller than a respective predetermined value as having a risk of arrhythmia" as amended claim 28 recites. Applicant mentions that the Office cites Hess for its teaching of arginine (Arg). However, Applicant states that according to claim 28, Arg is used only together with Threonine (Thr) and Hess teaches nothing about Thr. Therefore, Applicant asserts that Hess is not an anticipatory reference because Hess does not teach all the elements of claim 28. Applicant further states that Eilat-Adar does not remedy the deficiencies of Hess and in the absence of any teaching or suggestion of the elements noted above that are missing in the prior art, there is no prima facie case of obviousness.
In response, Applicant’s arguments are not persuasive because Hess teaches measuring Thr concentration in Table 4-1 SERUM AMINO ACID LEVELS (Page 125). Table 4-1 lists measured amino acid levels, including threonine for subjects. Table 4-1 meets the claim limitation of measuring concentration values of Thr in a blood sample of a subject and identifying the subject having the measured concentration value of Thr recited in claim 28. Hess also teaches "Previous studies have shown that serum levels of nitric oxide (NO) were reduced in MD patients and in patients with CVD. We measured serum levels of arginine, the precursor amino acid of NO and found that they were reduced in MD subjects compared to healthy controls (HCs)." (Abstract). This teaching meets the claim limitation of measuring concentration values of Arg in a blood sample of a subject as recited in claim 28. Hess also teaches the new claim limitation of performing a treatment on the identified subject for the risk of arrhythmia with "In cases where MD patients exhibit CVD and are at risk of MI, treatment with conventional antidepressants may decrease the severity of CVD symptoms and improve outcome." (Page 25, para. 3). Therefore, Hess anticipates claim 28 as discussed above in the claim rejections under 35 USC 102 section.
Conclusion
No claims are allowed.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/K.K./Examiner, Art Unit 1686
/LARRY D RIGGS II/Supervisory Patent Examiner, Art Unit 1686
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