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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 30 December 2025 has been entered.
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.
Claims 1, 3, 5, 6 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.
Claim 1 calls for using “a correspondence relation between the heart failure index and a biomarker indicating a severity of heart failure [] obtained over a period including a date of admission and a date of discharge for the subject” to set a threshold for the heart failure index. The specification does discuss finding such a correspondence relation (see figures 17, 18A, 18B, and associated discussion), but does not disclose using this relation to set any sort of threshold. At best the disclosure generally suggests the concept of a threshold for the HFI and uses this relationship to illustrate why it would be useful, but at no point is there disclosure of how such a threshold would be set or actively doing so beyond calling for use of “a predetermined threshold” (see p. 23, paragraph [0060] as filed), and in particular does not disclose the threshold being “a level between a value of the biomarker on the date of admission and a value of the biomarker on the date of discharge”. The same issue is found in claim 6. As such, the disclosure does not reasonably convey possession of use of a correspondence relation between heart failure index and a biomarker obtained over a particular period for setting a threshold for a heart failure index at the time the invention was filed.
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.
Claims 1, 3, 5, 6 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 1 recites, in part:
“wherein, a correspondence relation between the heart failure index and a biomarker indicating a severity of heart failure has been obtained over a period including a date of admission and a date of discharge for the subject, and, based on the correspondence relation between the heart failure index and the biomarker, a threshold for the heart failure index is preset to correspond to a level between a value of the biomarker on the date of admission and a value of the biomarker of the date of discharge for the subject”.
It is unclear if this is intended to include some active measurement, or if this is historic data; it is additionally unclear how these dates might relate to active use of the device, and whether operation of the device is time-dependent. The same is found in claim 6. Clarification 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.
Claim(s) 1, 3, 5 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “calculate… a systolic blood pressure and a diastolic blood pressure”, “obtain a blood pressure variation amount”, “extract a pulse wave signal superimposed on the cuff pressure signal… and acquire amplitudes of the pulse wave signal”, “plot… the first series of amplitudes”, “identify each of the local maxima and each of the local minima”, “create… a local-maximum connection line… and a local-minimum connection line”, “obtain… the blood pressure variation amount synchronized with respiration”, “refer to the correspondence relation”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. The recited processor does no more than provide a technological environment for the execution of the abstract idea itself, and does not constitute a particular machine. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a cuff and a “main body” with pump, pressure sensor, display, memory, and processor. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by MPEP 2106.05(d), where determining the level of a biomarker 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) is held to be well-understood, routine, and conventional, and Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. The element of the processor is further configured to “act as an alarm unit” with no recited means of providing an alarm or other form of output, such that it appears to merely be a disembodied transmission of data as an output of a comparison, see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 3-5 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas or further limitations on abstract ideas already recited. Claims 3 and 5 are directed to aspects of the abstract idea itself. Thus, claim(s) 1, 3, and 5 is/are rejected under 35 U.S.C. 101.
Claim(s) 6 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 6 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 6 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “calculate… a systolic blood pressure and a diastolic blood pressure”, “obtain a blood pressure variation amount”, “extract a pulse wave signal superimposed on the cuff pressure signal… and acquire amplitudes of the pulse wave signal”, “plot… the first series of amplitudes”, “identify each of the local maxima and each of the local minima”, “create… a local-maximum connection line… and a local-minimum connection line”, “obtain… the blood pressure variation amount synchronized with respiration”, “refer to the correspondence relation”. This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. The recited processor does no more than provide a technological environment for the execution of the abstract idea itself, and does not constitute a particular machine. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are a cuff and a “main body” with pump, pressure sensor, display, memory, and processor. However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by MPEP 2106.05(d), where determining the level of a biomarker 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) is held to be well-understood, routine, and conventional, and Alice v. CLS Bank and Bilksi v. Kappos, which held that generic computer structure does not otherwise transform a patent-ineligible claim into a patent-eligible one. The element of the processor is further configured to “act as an alarm unit” with no recited means of providing an alarm or other form of output, such that it appears to merely be a disembodied transmission of data as an output of a comparison, see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 6 fails to recite patent-eligible subject matter under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 30 December 2025 have been fully considered but they are not persuasive.
Applicant first argues that controlling the processor to “act as a cuff pressure control unit” to acquire a pressure signal and then find systolic and diastolic blood pressures is a “physical pressure change process” that “directly reflects a physiological response of the subject during measurement”, thus being “well beyond mere data processing”. As noted above, acquiring blood pressures is, in the context of the invention as claimed, insignificant extrasolution data gathering activity using conventional sensors (the cuff and pump) to gather the necessary data for the abstract idea, and is not part of the abstract idea itself which is evaluated in step 2A, prong one. The use of these components is not an integration of the abstract idea itself, the processing of the pressure data, as being applied with or using any sort of particular machine, such that this is entirely unpersuasive.
Applicant continues by asserting that the “clinically significant threshold determination process” (that is, selecting some value between two other values) “could not be performed as a mental process”. As no part of this “determination process” is recited in the claims beyond the threshold being a value which happens to lie between two other values, no part of the assertion that this could not be performed as a mental process is persuasive.
Applicant then argues that the invention as claimed “appl[ies] this clinically derived threshold to effect a concrete health management action” by providing a notification; again, outputting a result is not part of the abstract idea which has been identified above and in previous Office Actions, and is merely the postsolution activity of outputting that result of the comparison of a value to a threshold, such that this is also unpersuasive.
Applicant continues by asserting that “these claim elements demonstrate integration into the practical application of heart failure patient health management” – as Applicant’s remarks above were addressing step 2A, prong one, it is entirely unclear how these same remarks would thus satisfy the requirements of step 2A, prong 2 of evaluation which addresses integration into a practical application. Still further, the “practical application of heart failure patient health management” is not a practical application as recognized by the Office. As noted above, none of interaction with a subject for the purpose of data gathering, selecting a threshold from previously derived data, or outputting the result of a comparison using that threshold could be considered a tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing, such that this general allegation of integration is entirely unpersuasive.
The claims remain rejected.
Conclusion
No art has been applied against the claims at this time; however, as all the claims are rejected under 112 and 101 they are not presently allowable and the question of prior art will be revisited, if applicable, upon resolution of these other issues.
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/KAREN E TOTH/Examiner, Art Unit 3791
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