DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 21-33, drawn to a method of monitoring cardiac output in a patient, classified in A61B5/0215.
II. Claims 34-45, drawn to a system of monitoring cardiac output in a patient, classified in A61B5/7275.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the process as claimed can be practiced by another and materially different apparatus that does not comprise a base unit configured to wirelessly communicate with the pressure sensor; a second computer configured to communicate with the base unit.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
Each group of invention has separate classification and separate status in the art. Further, each group of invention requires a different field of search and different search terms and databases because each group of invention possesses a distinct element not possessed by the other groups of invention as set forth above.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Dean Small on December 8, 2025 a provisional election was made without traverse to prosecute the invention of Group II, claims 34-45. Affirmation of this election must be made by applicant in replying to this Office action. Claims 21-33 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (16/893542 filed on 6/5/2020; 14/086478 filed on 11/21/2013; 61/799536 filed on 3/15/2013; and 61/728913 filed on 11/21/2012) are acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8 November 2023 and 6 January 2025 have been considered by the examiner.
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.
Claims 34-45 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 34, and all dependent claims thereof, recites “the pressure sensor” in line 4, which is indefinite. Does this refer to the “wireless pressure sensor” previously recited in line 2?
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 34-45 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 1, 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; estimate first and second cardiac outputs (COest) of the patient based on first and second CO changes, where the first and second CO changes are determined based on the PAP values; 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 35-44 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 34-45 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 34-45 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”)
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 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”); estimate first and second cardiac outputs (COest) of the patient based on first and second CO changes, where the first and second CO changes are determined based on the PAP values (par.0006 “estimating stroke volume and cardiac output using… a pressure signal from… PAP sensor… using a change in the PAP”, which also suggests assessing changes in stroke volume and/or cardiac output; par.0080 “compute the stroke volume or cardiac output of a patient’s heart… using information from the PAP sensor 320, such as by using at least one detected PA pressure characteristic or other information received from the PAP sensor 320”); 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 (par.0033 “providing an iteratively-updating model that relates PAP and HR to at least one of a stroke volume (SV) and cardiac output (CO)”, of which relating these values equates to comparing the first COest and the second COest with one another, in order to provide a comprehensive estimation of cardiac output of the patient, as depicted in Fig. 5).
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 40, Soffer suggests the processor further configured to obtain 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 (Abstract; par.0054, 0085, 0098; Fig. 4).
With respect to claim 41, Soffer suggests calculate first and second impedance change effects based on the PAP values; determine the first and second CO changes based on the first and second impedance change effects; and subtract the first and second CO changes from the COref to obtain the first COest and the second COest (par.0009, 0054, 0061, 0067, 0085).
With respect to claim 42, Soffer suggests wherein the processor is further configured to measure the COref (Abstract; Fig. 5).
With respect to claim 43, Soffer suggest wherein the COref is a standard CO target value for a patient population (Abstract; Fig. 5).
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).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 34-45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,709,341; and claims 1-20 of U.S. Patent No. 11,832,920. Although the claims at issue are not identical, they are not patentably distinct from each other because they are obvious variants of one another.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791