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
Acknowledgement is made of applicant’s amendment which was received by the office on August 25, 2025. Claims 2,4, 25, 51 and 124-140 are pending. Claims 2,4,25, 124, 130-132 and 136-137 were previously withdrawn. Claims 51, 125-129,133-135 and 138-140 are under examination.
Drawings
The drawings filed on 8/25/2025 are unacceptable. The drawings filed on 8/25/2025 are objected to because the unlabeled rectangular boxes shown in the drawings, see Fig. 16, should be provided with descriptive text labels. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The abstract of the disclosure is objected to because the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b), see response filed 8/25/2025. A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 51, 125-129,133-135 and 138-140 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 51, 125-129,133-135 and 138-140 is/are drawn a method and/or device which is/are a statutory category of invention (Step 1: YES).
The claim limitations within independent claims 51 and 140 that set forth or describe the abstract idea is/are: “interpret a risk of a presence of wasting of a left ventricular muscle mass based on the cardiopulmonary measurement of the subject”. The reasons that the limitations is/are considered an abstract idea is/are the following: The limitations of , “interpreting a risk of a presence of wasting of a left ventricular muscle mass based on the cardiopulmonary measurement of the subject” is a process that under its broadest reasonable interpretation covers performance of the limitation in the mind with the assistance of pen and paper but for the recitation of generic computer components. For example, “interpret a risk of a presence of wasting of a left ventricular muscle mass based on the cardiopulmonary measurement of the subject” in the context of this claim encompasses the user interpreting, with the aid of pen and paper, a risk of a presence of wasting of a left ventricular muscle mass using a cardiopulmonary measurement of the subject. There is nothing to suggest an undue level of complexity in the interpreting step. If a claim limitation, under its broadest reasonable interpretation covers a metal process, i.e. performance of the limitation in the mind, but for the recitation of generic computer components, then it falls with the “Mental Processes” grouping of abstract ideas. Accordingly the claims recite an abstract idea. Although not drawn to the same subject matter, the claimed limitation(s) is/are similar to concepts that have been identified as abstract by the courts, such as: collecting information, analyzing it, and reporting certain results of the collection and analysis in Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016), selecting certain information, analyzing it using mathematical techniques, and reporting or displaying the results of the analysis in SAP America Inc. v. Investpic, LLC, 890 F.3d 1016, 126 USPQ2d 1638 (Fed Cir. 2018). Thus, the claim(s) are directed to a judicial exception and fall squarely within the realm of "abstract ideas," which is a patent-ineligible concept (Step 2A: Prong One YES).
Analyzing the claim as whole for a practical application, the claim does not include additional elements/steps that are sufficient to amount to significantly more than the judicial exception. The additionally recited element(s) appended to the abstract idea in claims include: “using an interoperable electronic device to measure a cardiopulmonary measurement of a subject, wherein the interoperable electronic device comprises a loop recorder, a cardioverter defibrillator, or a combination thereof, and wherein the cardiopulmonary measurement comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec;” and “transmitting a detection of the risk of the presence of the wasting of the left ventricular muscle mass to a second device”. The additional elements of “using an interoperable electronic device to measure a cardiopulmonary measurement of a subject, wherein the interoperable electronic device comprises a loop recorder, a cardioverter defibrillator, or a combination thereof, and wherein the cardiopulmonary measurement comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec;” and “transmitting a detection of the risk of the presence of the wasting of the left ventricular muscle mass to a second device” merely: add insignificant extra-solution activity, reciting “an interoperable electronic device to measure a cardiopulmonary measurement” is recited at a high level of generality (i.e. as a general means of gathering a cardiopulmonary measurement) and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere data gathering, which is a form of insignificant extra-solution activity (pre-solution activity). All uses of the recited judicial exception require the pre-solution activity of data gathering. Reciting “transmitting a detection of the risk of the presence of the wasting of the left ventricular muscle mass to a second device” is recited at a high level of generality and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to insignificant application, which is a form of insignificant extra-solution activity (post-solution activity), see MPEP 2106.05(g). Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (Step 2A, Prong Two, NO).
The claims not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. e.g., all elements being directed to insignificant extra-solution activity including pre-solution activity, post-solution activity carried out using well-understood routine, conventional activities previously known to the industry and amount to elements that have been recognized as well-understood, routine and conventional activity in particular fields e.g. receiving or transmitting data over a network, Symantec, see MPEP 2106.05(d)(II), the additional elements do not amount to significantly more than the above-identified judicial exception(s). Utilizing an interoperable electronic device that includes a cardioverter defibrillator and/or loop recorder to determine cardiopulmonary measurements (i)-(iii) was known within the art, see US 2017/0332942 to Pflugh et al. which utilizes cardioverter defibrillator and loop recorders (e.g. para. [0004], [0018]) for measuring parameters to provide statistical values including pNN50 (e.g. para. [0067]) and/or US 2015/0141851 to Sharma which utilizes cardioverter defibrillator (e.g. para. [0003], [0064]) for measuring parameters to provide statistical values including SDANN (e.g. para. [0005], [0064]) and/or US 2008/0300641 to Brunekreeft et al. which utilizes cardioverter defibrillator (e.g. para. [0032]) for measuring parameters to provide statistical values including SDANN and pNN50 (e.g. para. [0041]) and/or US 2018/0336969 to Jabourian which utilizes loop recorder (e.g. para. [0004]) for measuring parameters related to premature ventricular contractions (e.g. para. [0004]). Similarly, when considered as an ordered combination, the additional components/steps of the claim(s) add nothing that is not already present when the steps are considered separately (Step 2B: NO). The claims are not patent eligible.
Claim(s) 125-129,133-135 and 138-139 depend directly or indirectly from claim(s) 51. Therefore, the dependent claims rely upon the same abstract idea as the independent claim(s), as set forth above. Additionally, the dependent claims do nothing more than further limiting the abstract idea while failing to qualify as "significantly more", and the specificity of an abstract idea does not make it any "less abstract" as it is still directed to concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work subject matter. Therefore, the dependent claim(s) are also not patent eligible for the reasons discussed above. Claim(s) 125-129,133-134 and 138 fail(s) to provide significantly more, when considered as an ordered combination, as it/they merely provide further limitation regarding the subject and/or what is interpreted, which can still nonetheless be considered a mental processes, i.e. performed by a human using a pen and paper. Claim(s) 135 and 139 fail(s) to provide significantly more, when considered as an ordered combination, as it/they merely provide further limitation regarding the “data gathering” which merely: add insignificant extra-solution activity, and is merely nominally, insignificantly or tangentially related to the performance of the steps, i.e. amounts to mere data gathering, which is a form of insignificant extra-solution activity (pre-solution activity). All uses of the recited judicial exception require the pre-solution activity of data gathering.
The instantly rejected claim(s) are therefore not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. In the interest of advancing prosecution, the examiner suggests: providing evidence, for example, delineating how the abstract idea and/or additional elements appended to the abstract idea results in an improvement to the technology/technical field, which can show eligibility and/or adding a practical application of the claimed method outside of the computer (e.g. treating a patient). See MPEP § 716.01(c) for examples of providing evidence supported by an appropriate affidavit or declaration. For additional guidance, applicant is directed generally to MPEP § 2106.
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 51, 125-129,133-135 and 138-140 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. Claims 51 and 140 recite measuring “a cardiopulmonary measurement that comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec “ and “interpret a risk of a presence of a wasting of a left ventricular mass based on the cardiopulmonary measurement of the subject”, however the original disclosure does not provide any steps/procedure and/or what values or parameters are being used to interpret a risk of a presence of a wasting of a left ventricular mass based on a cardiopulmonary measurement that comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec. One of ordinary skill in the art would not understand how the inventor intended the function to be performed. Applicant’s specification states verbatim what is within the claims “an interoperable electronic device configured to measure a cardiopulmonary measurement, interpret a risk of a presence of wasting of left ventricular muscle mass” (e.g. para. [0009], [0040]) but fails to disclose the details necessary to interpret a risk of a presence of a wasting of a left ventricular mass based on the cardiopulmonary measurement of the subject. The specification does not describe in sufficient detail how a cardiopulmonary measurement that comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec is used to interpret a risk of a presence of wasting of left ventricular muscle mass. Applicant has not disclosed any particular process or steps that are used to interpret a risk of a presence of a wasting of a left ventricular mass based on a cardiopulmonary measurement of the subject. Ultimately the specification is written generically such that it defines the invention in functional language specifying a desired result, i.e. interpret a risk of a presence of a wasting of a left ventricular mass based on a cardiopulmonary measurement of the subject, but does not sufficiently identify how the function is performed or how the result is achieved. Claim 138 recites “where the device further interprets a risk of sudden cardiac death in the subject.”, however the original disclosure does not provide any steps/procedure and/or what values or parameters are being used to interpret a risk of sudden cardiac death in the subject based on a cardiopulmonary measurement that comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec. One of ordinary skill in the art would not understand how the inventor intended the function to be performed. Applicant’s specification states verbatim what is within the claims “interpret a risk of sudden cardiac death in the subject based on a cardiopulmonary measurement” (e.g. para. [0213], [0215] of published application US 2023/0082989) but fails to disclose the details necessary to interpret a risk of sudden cardiac death in the subject based on a cardiopulmonary measurement. The specification does not describe in sufficient detail how a cardiopulmonary measurement that comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec is used to interpret a risk of sudden cardiac death. Applicant has not disclosed any particular process or steps that are used to interpret a risk of sudden cardiac death in the subject based on a cardiopulmonary measurement. Ultimately the specification is written generically such that it defines the invention in functional language specifying a desired result, i.e. interpret a risk of sudden cardiac death in the subject based on a cardiopulmonary measurement, but does not sufficiently identify how the function is performed or how the result is achieved. Therefore, 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. Claims 125-129,133-135 and 138-139 directly or indirectly depend form claim 51 and are also rejected for the reasons stated above regarding claim 51. As best understood, for the purpose of examination, since applicant has not disclosed how the inventor intended the function to be performed, it has been interpreted to include any function used for aiding in determining left ventricular wasting and sudden cardiac death.
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 51, 125-129,133-135 and 138-140 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. Claims 51 and 139-140 recite “ (ii) an average heart rate during a time period of from about 60 to about 100 bpm” it is unclear what time period applicant is attempting to encompass since “from about 60 to about 100 bpm” is not a time period, clarification is required. Claims 51 and 139-140 recite “and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec” it is unclear what time period applicant is attempting to encompass since applicant recites “from about 1 minute to about 60 minutes” which provides a broad range and then immediately recites a narrower range “less than about 100 msec”. Clarification is required. Claims 51 and 140 recite “a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10%” it is unclear what applicant is attempting to encompass. Less than 10% of what? Clarification is required. Claims 51 and 140 recite “and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec” it is unclear what time period applicant is attempting to encompass. Is applicant reciting a time period of at least 100 msec? Clarification is required. Claims 125-129,133-135 and 138-139 directly or indirectly depend form claim 51 and are also rejected for the reasons stated above regarding claim 51. As best understood, for the purpose of examination, (ii) has been interpreted to be an average heart rate over any time period and a standard deviation over any time period that includes a 5-minute average.
Response to Arguments
Claim Rejections Under 35 USC 101
Applicant's arguments filed 8/25/2025 have been fully considered but they are not persuasive. Applicant argues “Claim 51 amounts to significantly more than the judicial exception because loop recorders, cardioverter defibrillators, or a combination thereof were not routinely or conventionally used to detect the recited cardiopulmonary measurements of the claim, interpret a risk of cardiac wasting, and transmit that risk to a second device at the time the application was filed.”, see pg. 11 of response filed 8/25/2025. This is not persuasive. As currently recited within claim 51 the interoperable electronic device is used to measure the cardiopulmonary measurement of a subject it is not recited as being used to interpret a risk or transmit a detection. Utilizing an interoperable electronic device that includes a cardioverter defibrillator and/or loop recorder to determine cardiopulmonary measurements (i)-(iii) was known within the art, see US 2017/0332942 to Pflugh et al. which utilizes cardioverter defibrillator and loop recorders (e.g. para. [0004], [0018]) for measuring parameters to provide statistical values including pNN50 (e.g. para. [0067]) or US 2015/0141851 to Sharma which utilizes cardioverter defibrillator (e.g. para. [0003], [0064]) for measuring parameters to provide statistical values including SDANN (e.g. para. [0005], [0064]) or US 2008/0300641 to Brunekreeft et al. which utilizes cardioverter defibrillator (e.g. para. [0032]) for measuring parameters to provide statistical values including SDANN and pNN50 (e.g. para. [0041]) or US 2018/0336969 to Jabourian which utilizes loop recorder (e.g. para. [0004]) for measuring parameters related to premature ventricular contractions (e.g. para. [0004]).
Applicant argues “Applicant asserts that claim 51 as currently amended is analogous to example 29, claim 4 of the USPTO’s patent subject matter eligibility guidance, and that the instant claim is eligible under 35 U.S.C. § 101 for at least this reason.”, see pg. 11 of response filed 8/25/2025. This is not persuasive. Unlike example 29, claim 4, claim 51 does not include an unconventional step that is more than mere instruction to “apply” using well-understood, routine or conventional techniques.
Claim Rejections Under 35 USC 112
Applicant's arguments filed 8/25/2025 have been fully considered but they are not persuasive. Applicant argues “Without acquiescing to the reasonableness of the rejection and entirely for purposes of compact prosecution, claim 51 has been amended to recite “interpreting a risk of a presence of a wasting of a left ventricular muscle mass based on the cardiopulmonary measurement of the subject”, and hence the rejection of the claim is rendered moot.”, see pg. 11 of response filed 8/25/2025. This is not persuasive. As stated within the rejection, applicant’s specification states verbatim what is within the claims “an interoperable electronic device configured to measure a cardiopulmonary measurement, interpret a risk of a presence of wasting of left ventricular muscle mass” (e.g. para. [0009], [0040]) but fails to disclose the details necessary to interpret a risk of a presence of a wasting of a left ventricular mass based on the cardiopulmonary measurement of the subject. The specification does not describe in sufficient detail how a cardiopulmonary measurement that comprises at least two measurements selected from the group consisting of: (i) from about 10 to about 5,000,000 premature ventricular contractions in a time period of from about 30 seconds to about 3 weeks; (ii) an average heart rate during a time period of from about 60 to about 100 bpm and a standard deviation of a 5-minute average NN interval (SDANN) during a time period of from about 1 minute to about 60 minutes that comprises less than about 100 msec; and (iii) a percentage of successive normal sinus R-R intervals >50 msec (pNNSO) that comprises less than 10% and an SDANN during a time period of from about 1 minute to about 60 minutes of at least 100 msec is used to interpret a risk of a presence of wasting of left ventricular muscle mass.
Claim Rejections Under 35 USC 103
In view of the claim amendments, applicant’s arguments, see pg. 12-13, filed 8/25/2025, with respect to the 103 rejections using Reza against claims 51, 122-123, 125-129, 133-135 and 138 have been fully considered and are persuasive. The 103 rejections using Reza against claims 51, 122-123, 125-129, 133-135 and 138 have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
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/JENNIFER L GHAND/Examiner, Art Unit 3796