DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s arguments filed in the reply on May 20, 2026 were received and fully considered. Claims 34, 40, and 42 were amended. Claim 43 was cancelled. Claim 46 is new. The current action is FINAL. Please see corresponding rejection headings and response to arguments section below for more detail.
Claim Rejections - 35 USC § 112B
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.
Claim 46 is 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 46 recites “the COref” in line 2, which lacks antecedent basis.
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 34-42 and 44-46 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 34 follows.
Regarding claim 34, the claim recites a system of monitoring cardiac output in a patient. Thus, the claim is directed to a machine/apparatus, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“…determine, based on the PAP data, PAP values experienced within the pulmonary artery of the patient over time; determine first and second cardiac output (CO) changes based on the PAP values; estimate first and second cardiac outputs (COest) of the patient based on first and second CO changes; compare the first COest and the second COest with one another; and monitor the cardiac output of the patient based on the comparison of the first COest and the second COest.”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…a wireless pressure sensor configured to be implanted in a pulmonary artery of the patient and to obtain pulmonary artery pressure (PAP) data for the patient; a base unit configured to wirelessly communicate with the pressure sensor; a second computer configured to communicate with the base unit; at least one of the base unit or second computer including a processor…”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, i.e., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they relate to well-understood, routine, and conventional components for obtaining PAP data. Moreover, “a wireless pressure sensor… implanted in a pulmonary artery” is recited at a high level of generality such that it fails to amount to a particular machine. See MPEP 2106.05(b). Lastly, “a base unit”, “a second computer”, and “a processor” merely execute the judicial exception and/or are involved with conventional data transmission, and accordingly does not amount to a particular machine. See Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 706-17 (Fed. Cir. 2014), cited in MPEP § 2106.05(b)(I).
Dependent claims 35-42, 44, and 46 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Dependent claim 45 recites “administer the candidate agent to the patient to treat the PAH of the patient”, however this fails to integrate the claims into a practical application for the following reasons. First, the recited treatment step does not appear to be linked to the judicial exception. Moreover, the recited treatment step is highly generic and does not constitute a particular treatment. See MPEP 2106.04(d)(2).
Therefore, claims 34-42, 44, and 46 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 34-39, 44, and 45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soffer et al. (US PG Pub. No. 2010/0056931 A1) (hereinafter “Soffer”) in view of Stahlberg et al. (Estimating changes in cardiac output using an implanted hemodynamic monitor in heart failure patients, Scandinavian Cardiovascular Journal, pgs. 201-208, 2010) (hereinafter “Stahlberg”).
Soffer was applied in the previous office action.
With respect to claim 34, Soffer teaches a system of monitoring cardiac output in a patient (abstract “system and method… compute a stroke volume and cardiac output”), comprising: a wireless pressure sensor configured to be implanted in a pulmonary artery of the patient and to obtain pulmonary artery pressure (PAP) data for the patient (par.0005 “Wireless sensors implanted in the heart and great vessels provide many advantages for monitoring pressures, including direct measurements of clinically valuable data, such as pressure in pulmonary artery”; par.0006 “receives a pressure signal from a single Pulmonary Artery Pressure (PAP) sensor”; see also PAP sensor 320 in Fig. 1); a base unit configured to wirelessly communicate with the wireless pressure sensor (par.0070 “a telemetry link 326 between the PAP sensor 320 and the external system 302”); at least one of the base unit or second computer including a processor (par.0077 “processor 321”) configured to: determine, based on the PAP data, PAP values experienced within the pulmonary artery of the patient over time (par.0073 “sensed PAP signal… sensor signal processing system 321 that can receive and process the PAP signal”);
However, Soffer does not explicitly teach determine first and second cardiac output (CO) changes based on the PAP values; estimate first and second cardiac outputs COest of the patient based on first and second CO changes; compare the first COest and the second COest with one another; and monitor the cardiac output of the patient based on the comparison of the first COest and the second COest.
Stahlberg teaches determine first and second cardiac output (CO) changes based on the PAP values; estimate first and second cardiac outputs COest of the patient based on first and second CO changes; compare the first COest and the second COest with one another; and monitor the cardiac output of the patient based on the comparison of the first COest and the second COest (abstract “algorithm that estimates changes in cardiac output… from an implantable hemodynamic monitor”; see pg. 207, Conclusions “simple algorithm based on RV pressure waveform data derived from an implantable hemodynamic monitor system can estimate changes in cardiac output in heart failure patients… helpful to identify changes in CO over time”).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art (“PHOSITA”) at the time of invention to modify Soffer to further incorporate determining/estimating changes in cardiac output, in the manner recited, for the purpose of improving trend analysis of cardiac output over time in heart failure patients, as evidence by Stahlberg.
Although Soffer does not expressly teach a second computer configured to communicate with the base unit, further modification to incorporate a second computer would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Soffer expressly discloses the following:
[0084] In an example, the sensor signal processing system 321 can be configured to provide a notification of the computed cardiac output or estimated stroke volume to an external device 302, such as an external repeater, or other device capable of communicating with the processor 321. In certain examples, the external device, IMD, or other device can be configured to communicate, such as by an e-mail or other communication, to a user, such as a physician or other caregiver, or the subject.
Moreover, it is widely known in the art to provide additional computers and mobile terminals (mobile phone, computer in nurse station, doctor office, etc.) for the purpose of communicating a diagnostic result to other users. Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Soffer to incorporate a second computer in order to communicate estimated cardiac output to other authorized users, nurses, doctors, etc.
With respect to claim 35, Soffer suggests wherein the processor is further configured to determine first and second mean PAP changes based on the PAP values, the first COest and the second COest estimated based on the first and second mean PAP changes, respectively (Abstract; par.0081-0083, 0088).
With respect to claim 36, Soffer suggests wherein the PAP values are determined for first and second time frames, the processor further configured to calculate first and second mean PAPs (mPAP) based on the PAP values for the corresponding first and second time frames, the first COest and the second COest estimated based on the first and second mPAPs, respectively (Abstract; par.0081-0083, 0088).
With respect to claim 37, Soffer suggests wherein the processor is further configured to analyze the PAP values to identify, for multiple cardiac beats, at least one of: i) P1,T1 pressure and time associated with a systole feature of interest, ii) P2, T2 pressure and time associated with a diastole feature of interest, or iii) P3,T3 pressure and time associated with a right ventricle (RV) incident wave (par.0088).
With respect to claim 38, Soffer suggests wherein the P2, T2 pressure and time associated with the diastole feature of interest are demarcated by a dicrotic notch in the PAP values (par.0020-0022, 0088, 0096).
With respect to claim 39, Soffer suggests wherein the processor is further configured to analyze the PAP values to identify a pressure associated with a right ventricle (RV) incident wave (RV incident pressure), the first COest and the second COest estimated based on the corresponding RV incident pressures (Abstract; par.0091).
With respect to claim 44, Soffer suggests wherein the processor is further configured to: monitor pulmonary arterial hypertension (PAH) of the patient over the time based, in part, on the comparing of the first COest and the second COest (par.0073, 0076).
With respect to claim 45, Soffer suggests wherein the processor is further configured to: identify a candidate agent, from the one or more pharmaceutical agents, for the patient based on the PAH monitored; and administer the candidate agent to the patient to treat the PAH of the patient (par.0073, 0076).
Claims 40 and 42 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soffer and Stahlberg, as applied to claim 34, in further view of Doron (US PG Pub. No. 2010/0094144 A1).
With respect to claims 40 and 42, Soffer and Stahlberg render obvious a system of monitoring a cardiac output in a patient, as set forth above.
However, Soffer and Stahlberg do not teach the limitations further recited in claims 40 and 42.
Regarding claim 40, Doron teaches the processor further configured to measure a reference cardiac output (COref), wherein the estimation of first and second cardiac outputs (COest) of the patient are based, in part, on the COref (par.0041 “calibrated directly measuring the cardiac output in a separate step using a thermodilution catheter during an invasive procedure, or alternatively, using the Fick method… From this separate cardiac output measurement… comparing these signals… calibration process can then be repeated one or more times”).
With respect to claim 42, Doron teaches teaches wherein the processor is further configured to measure the COref utilizing at least one of a thermodilution, modified Fick or Fick technique (par.0041 “calibrated… using a thermodilution catheter during an invasive procedure, or alternatively, using the Fick method”).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Soffer and Stahlberg to incorporate applying initial calibration by directly measuring CO (equates to measuring a reference CO) via thermodilution or applying Fick method in order to account for presence of any noise, as evidence by Doron (par.0041).
Claim 41 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soffer, Stahlberg, and Doron, as applied to claim 40, in further view of McGee et al. (Validation of a continuous, arterial pressure-based cardiac output measurement: a multicenter, prospective clinical trial, Critical Care, pgs. 1-7, September 19, 2007) (hereinafter “McGee”).
With respect to claim 41, Soffer, Stahlberg, Doron render obvious a system of monitoring a cardiac output in a patient, as set forth above. Soffer also suggests calculate first and second impedance change effects based on the PAP values (par.0009, 0054, 0061, 0067, 0085); and Stahlberg teaches determine the first and second CO changes based on the first and second impedance change effects (abstract; see also bottom of pg. 205).
However, Soffer, Stahlberg, and Doron do not teach the limitations further recited in claim 41.
Regarding claim 41, Mcgee teaches subtract the first and second CO changes from the COref to obtain the first COest and the second COest (see bottom of pg. 2, right column “the change in cardiac output (∆CO) was calculated as the difference in cardiac output at two time points divided by the mean cardiac output at those two time points”).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Soffer, Stahlberg, Doron to incorporate subtracting first/second CO changes in the manner recited in order to accurately measure change in cardiac output, as evidence by McGee (see bottom of pg. 2, right column).
Claim 46 rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Soffer and Stahlberg, as applied to claim 34, in further view of McGee.
With respect to claim 46, Soffer and Stahlberg render obvious a system of monitoring a cardiac output in a patient, as set forth above.
However, Soffer and Stahlberg do not teach the limitations further recited in claim 46.
Regarding claim 46, Mcgee teaches subtract the first and second CO changes from the COref to obtain the first COest and the second COest (see bottom of pg. 2, right column “the change in cardiac output (∆CO) was calculated as the difference in cardiac output at two time points divided by the mean cardiac output at those two time points”).
Therefore, it would have been prima facie obvious to PHOSITA at the time of invention to modify Soffer and Stahlberg to incorporate subtracting first/second CO changes in the manner recited in order to accurately measure change in cardiac output, as evidence by McGee (see bottom of pg. 2, right column).
Response to Arguments
Applicant’s arguments filed with respect to the 35 USC 112B rejections raised in the previous office action were persuasive in view of amendment. However, the amendment creates new indefinites issues. Please see corresponding rejection heading above for more detail.
Applicant’s arguments filed with respect to the 35 USC 101 rejections raised in the previous office action were fully considered, but they are not persuasive. Applicant appears to argue that a human mind is not equipped to perform the limitations corresponding to the judicial exception. Examiner respectfully disagrees as nothing suggests that the skilled artisan would not be able to practically perform the steps corresponding to the judicial exception, mentally, or using simple pen/paper. Moreover, Examiner maintains that steps such as determining changes, estimating outputs based on the changes, comparing, etc. describe mathematical concepts, relationships1. Applicant goes on to argue that the claims recite an improvement, appearing to suggest the implied temporal nature of the claims “multi-year life of the system” versus “semi-annual doctor visits”. Examiner respectfully disagrees as nothing from the claim requires any temporal requirement. Merely performing the recited calculations more than once is within the bounds of the patent claim, which the skilled artisan would be able to achieve. Nonetheless, implementing calculations, simple or complex, iteratively, over a time period (short or long) on a generic processor would still not be patent eligible2. Examiner also argues that the purported improvement appears to lie within the judicial exception itself. However, the judicial exception alone cannot provide the improvement. See MPEP 2106.05(a). For at least these reasons, the 35 USC 101 rejections are maintained.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered, but are moot in view of the combination of references applied in the current office action. Please see prior art section above for more detail, updated citations (new secondary references: Stahlberg, Doron, and McGee), and updated obviousness rationale.
Applicant’s arguments filed with respect to the double patenting rejections raised in the previous office action were persuasive in view of the submitted terminal disclaimer, which was approved on May 20, 2026. Therefore, these rejections are withdrawn.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 It is important to note that a mathematical concept need not be expressed in mathematical symbols, because "[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989).
2 See patent eligible claim 2 of Example 47 in AI-related SME examples issues in 2024
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