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 .
Response to Amendment
In response to amendment filed February 2, 2026, claims 25, 27, 33-34 and 50 are amended. Claims 52-53 are added and claims 1-24 and 35-42 are cancelled. Claims 25-34 and 43-54 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed February 2, 2026, with respect to claim objections have been fully considered and are persuasive in view of the amendment. The objection of claim 32 has been withdrawn.
Applicant's arguments filed February 2, 2026 with respect to the rejection of claims under 35 U.S.C 101 have been fully considered but they are not persuasive.
In response to applicant’s arguments that the claims do not recite an abstract idea, Examiner respectfully disagrees. The abstract ideas is identified as the step determining. That is, as broadly and reasonably interpreted, the above recited step of determining is a step that can practically be performed in the mind or with the aid of pen/paper. An experienced medical professional can perform the claimed step of determining by mentally determining how much of a blood vessel is congested by looking at the obtained signals. Thus, the claims can be readily interpreted as being a mere application of a mental process on a computer. An improved abstract idea is still an abstract idea even if such an abstract idea results in more accurate results. Applicant refers to the tangible claim elements that are in addition to the abstract idea (i.e., the additional elements). Applicant argues that because the additional elements are tangible, the claims are not directed to an abstract idea. However, this is not the test for eligibility. “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility.” MPEP 2106.04(d) I. citing Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USOQ2d 1976, 1983-84 (2014). Thus, applicant’s identification of the additional elements in the claims as not being abstract does not influence the eligibility analysis. Applicant should not conflate the abstract idea with the elements of the claim that are in addition to the abstract idea (i.e. additional elements).
In response to Applicant’s argument that the claims integrate the abstract idea into practical application, Examiner respectfully disagrees. An improvement to the technology cannot be in the abstract idea. MPEP 2106.05a. “[L]imitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.” MPEP 2106.05(h). “[T]he additional element in Flook ... was not sufficient to make the claim eligible, because it was merely an incidental or token addition to the claim that did not alter or affect how the process steps of calculating the alarm limit value were performed.” Further, The data-gathering steps of obtaining; and wirelessly receiving and the data-output step of providing do not add a meaningful limitation to the method as they are insignificant extra-solution activity. Furthermore, the abstract idea amounts to simply implementing the abstract idea on a computer with steps of obtaining; determining; prompting; providing; detecting; wirelessly receiving and remotely energizing. The additional elements are identified in the 101 section below as being the elements that comprise a sensor and a processor. When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Applicant’s arguments, see Remarks, filed February 2, 2026, with respect to the rejection(s) of claims under 35 U.S.C 103 have been fully considered and are persuasive in view of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gifford (US 20190167188 A1).
Information Disclosure Statement
Applicant has submitted 224 foreign patent documents, 78 non-patent literature references and 640 US patent documents.
Although a concise explanation of the relevance of the information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted and how it is understood to be relevant. Concise explanations (especially those which point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more are highly relevant to patentability. MPEP 609.04(a) III.
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 25-33 and 43-54 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 25-33 and 43-54 are all within at least one of the four categories.
The independent claim 25 recites:
determine the congestion in a blood vessel of the vessel based on the first and second signals
The independent claim 33 recites:
determining the congestion in a blood vessel of the vessel based on the first and second signals.
The independent claim 50 recites:
determining the congestion in a blood vessel of the vessel based on the first and second signals.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. See footnotes 14 and 15.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018) (performing a resampled statistical analysis to generate a resampled distribution).
The claimed steps of determining can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
With respect to the pending claims, for example, an experienced medical professional can perform the claimed step of determining by mentally determining how much of a blood vessel is congested by looking at the obtained signals. Thus, the claims can be readily interpreted as being a mere application of a mental process on a computer.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. For example, dependent claims recite steps (e.g. determining, providing, detecting) that can be performed in the mind. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
The judicial exception (abstract idea) in claims 30-32 is integrated into practical application because it is directed towards a drug treatment schedule; a medical treatment schedule; and further specifies that the medical treatment schedule comprises at least one of a diuretic or vasodilation schedule, a modification to a medical device such as a vascular pump, drug pump, dialysis or auto-filtration machine, pacing device or extracorporeal membrane (ECMO) machine.
This judicial exception (abstract idea) in claims 21-29, 34 and 43-54 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for obtaining; determining; prompting; providing; detecting; wirelessly receiving and remotely energizing merely invoke a computer as a tool.
The data-gathering step (obtaining; wirelessly receiving) and the data-output step (providing) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for obtaining; determining; prompting; providing; detecting; wirelessly receiving and remotely energizing.
The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide information about a blood vessel.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for obtaining; determining; prompting; providing; detecting; wirelessly receiving and remotely energizing. The claims do not apply the obtained data to a particular machine. Rather, the data is merely output in an post-solution step.
The additional elements are identified as follows: a sensor; a processor
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
the non-patent literature cited by applicant:
Blehar, et al, Inferior vena cava displacement during respirophasic ultrasound imaging, Critical Ultrasound Journal (2012) 4:18
Huguet et al., Three-Dimensional Inferior Vena Cava for Assessing Central Venous Pressure in Patients with Cardiogenic Shock, J Am Soc Echocardiogr. 2018; 31: 1034-43 (https://doi.org/10.1016/ j.echo.2018.04.003)
Dehkordi et al., Extracting Instantaneous Respiratory Rate From Multiple Photoplethysmogram Respiratory-Induced Variations; Frontiers in Physiology, Vol. 9,Article 948; July 18, 2018 (DOI: 10.3389/fphys.2018.00948).
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25-26, 28-33, 43-45 and 48-54 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Horst (US 20190175035 A1; previously cited) in view of Gifford (US 20190167188 A1).
With respect to claim 25, Van der Horst discloses a system for determining congestion in a blood vessel (see paragraph 0041-0046 and Fig. 1, system #100) comprising:
a sensor configured to be implanted in the vessel (see Fig. 1 and paragraph 0046, sensor #202 disposed along elongate member #170 which is inside of vessel #80), the sensor further configured to generate a first signal indicating the first area measurement, a1, of the vessel prior to a patient maneuver (see paragraph 0050-0052 and 0078, sensor #202 can be used to obtain imaging data from the vessel, from which one or more measurement values associated with the vessel, such as cross section area can be determined; and see paragraph 0032, prior to a renal denervation treatment) and generate a second signal indicating the second area measurement, a2, of the vessel (see paragraph 0050-0052 and 0078, sensor #204 can be used to obtain imaging data from the vessel, from which one or more measurement values associated with the vessel, such as cross section area can be determined and further compared) […];
a processor (see paragraph 0040 and 0058-0060, processor #140) configured to determine the […] in a blood vessel of the vessel based on the first and second signals (see paragraph 0058-0060, processor can measure changes in vessel diameter using the signals obtained by sensors #202,204 and any suitable measurement value within the vessel is contemplated by the processor).
Van der Horst does not specifically teach the sensor further configured to make a first area measurement of the blood vessel and make a second area measurement of the blood vessel; and that a second signal indicating a second area measurement, a2, of the vessel is done after a patient maneuver. Van der Horst further does not specifically teach determining congestion in a blood vessel.
Gifford teaches making a first area measurement of the blood vessel before patient maneuver (see paragraph 0008, 0032-0037, 0043-0049: supplies perturbation testing and continued measurement where a baseline area signal is selected and retained immediately before leg raise) and making a second area measurement of the blood vessel after patient maneuver (see paragraph 0008, 0032-0037, 0043-0049: supplies perturbation testing and continued measurement where a baseline area signal is selected and retained immediately after leg raise). Gifford further teaches determining congestion in a blood vessel (see paragraph 0007, 0043, 0037: processor measures perturbation response for hypervolemic indication where hypervolemic assessment supplies a congestion indication).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Van der Horst with the teachings of Gifford because it would have resulted in the predictable result of basing diagnostic decisions and treatments on changes in IVC physical dimension to provide earlier warning of hypervolemia or hypovolemia and enabling the modulation of patient treatments to permit more stable long-term fluid management (Gifford: see abstract).
With respect to claim 26, all limitations of claim 25 apply in which Van der Horst further discloses wherein the processor is further configured to determine a patient fluid status based on an identified signal shape derived from the first and second area measurement signals (see paragraph 0015, pulse wave velocity of fluid is determined by processor; and see paragraph 0070-0071, signal shapes such as recognizable patterns).
With respect to claim 28, all limitations of claim 25 apply in which Van der Horst further discloses wherein the processor is further configured to provide a notification of a patient fluid status based on the first and second signals (see paragraph 0039, computing device outputs calculated PWV to display where clinician may make therapeutic decisions).
With respect to claim 29, all limitations of claim 25 apply in which Van der Horst in view of Toth further teaches wherein the processor is further configured to provide a notification indicating an action for reducing congestion in the blood vessel (Van der Horst: see paragraph 0039, therapeutic and diagnostic decisions are made by clinician).
With respect to claim 30, all limitations of claim 29 apply in which Van der Horst further discloses wherein the action comprises a drug treatment schedule (Van der Horst: see paragraph 0039, therapeutic and diagnostic decisions are made by clinician which include treatment schedule).
With respect to claim 31, all limitations of claim 29 apply in which Van der Horst further discloses wherein the action comprises a medical treatment schedule (Van der Horst: see paragraph 0039, therapeutic and diagnostic decisions are made by clinician which include treatment schedule).
With respect to claim 32, all limitations of claim 31 apply in which Van der Horst further discloses wherein the medical treatment schedule comprises at least one of a diuretic or vasodilation schedule, a modification to a medical device such as vascular pump, drug pump, dialysis or auto-filtration machine, pacing device or extracorporeal membrane oxygenation (ECMO) machine (see paragraph 0042, filtration and other devices).
With respect to claim 33, Van der Horst discloses
obtaining a first signal indicating a first area measurement, a1, from a sensor implanted in a blood vessel prior to a patient performing a patient maneuver (see Fig. 1 and paragraph 0046, sensor #202 disposed along elongate member #170 which is inside of vessel #80; and see paragraph 0050-0052 and 0078, sensor #202 can be used to obtain imaging data from the vessel, from which one or more measurement values associated with the vessel, such as cross section area can be determined; and see paragraph 0032, prior to a renal denervation treatment);
obtaining a second signal indicating a second area measurement, a2, from the sensor implanted in the blood vessel (see paragraph 0050-0052 and 0078, sensor #204 can be used to obtain imaging data from the vessel, from which one or more measurement values associated with the vessel, such as cross section area can be determined and further compared) […];
determining the […] in a blood vessel of the vessel based on the first and second signals (see paragraph 0058-0060, processor can measure changes in vessel diameter using the signals obtained by sensors #202,204 and any suitable measurement value within the vessel is contemplated by the processor).
Van der Horst does not specifically teach that a second signal indicating a second area measurement, a2, of the vessel is done after a patient maneuver. Van der Horst further does not specifically teach determining congestion in a blood vessel.
Gifford teaches making a first area measurement of the blood vessel before patient maneuver (see paragraph 0008, 0032-0037, 0043-0049: supplies perturbation testing and continued measurement where a baseline area signal is selected and retained immediately before leg raise) and making a second area measurement of the blood vessel after patient maneuver (see paragraph 0008, 0032-0037, 0043-0049: supplies perturbation testing and continued measurement where a baseline area signal is selected and retained immediately after leg raise). Gifford further teaches determining congestion in a blood vessel (see paragraph 0007, 0043, 0037: processor measures perturbation response for hypervolemic indication where hypervolemic assessment supplies a congestion indication).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Van der Horst with the teachings of Gifford because it would have resulted in the predictable result of basing diagnostic decisions and treatments on changes in IVC physical dimension to provide earlier warning of hypervolemia or hypovolemia and enabling the modulation of patient treatments to permit more stable long-term fluid management (Gifford: see abstract).
With respect to claim 43, all limitations of claim 33 apply in which Van der Horst further teaches wherein said determining the congestion comprises detecting change in wave patterns of the first and second signals indicating area measurements (Van der Horst: see paragraph 0058-0060, processor can measure changes in vessel diameter using the signals obtained by sensors #202,204 and any suitable measurement value within the vessel is contemplated by the processor).
With respect to claim 44, all limitations of claim 43 apply in which Van der Horst further discloses wherein said detecting a change in wave patterns comprises detecting a square wave pattern (see paragraph 0070-0071, signal shapes such as recognizable patterns).
With respect to claim 45, all limitations of claim 43 apply in which Van der Horst further discloses further comprising placing the sensor in the blood vessel comprises implanting the sensor in a patient's inferior vena cava (WC) (see Fig. 1 and paragraph 0046, sensor #202 disposed along elongate member #170 which is inside of vessel #80; and see paragraph 0066, inferior vena cava).
With respect to claim 48, all limitations of claim 33 apply in which Van der Horst further discloses wherein said obtaining the first signal and the second signal comprise wirelessly receiving vessel area trace signals from a remotely energized sensor (see paragraph 0062-0063, electrical connections between processing system and sensors where electrodes are positioned on patient to receive ECG signals).
With respect to claim 49, all limitations of claim 48 apply in which Van der Horst further discloses further comprising remotely energizing the sensor by delivering an electric field (see paragraph 0062-0063, various peripheral devices may include electrical connections between processing system and other components of system which may include antenna).
With respect to claim 50, Van der Horst discloses a system for determining congestion in a blood vessel (see paragraph 0041-0046 and Fig. 1, system #100) comprising:
a sensor configured to be disposed in the vessel (see Fig. 1 and paragraph 0046, sensor #202 disposed along elongate member #170 which is inside of vessel #80), the sensor further configured to obtain a first signal indicating the first area measurement, a1, of the vessel prior to a patient maneuver (see paragraph 0050-0052 and 0078, sensor #202 can be used to obtain imaging data from the vessel, from which one or more measurement values associated with the vessel, such as cross section area can be determined; and see paragraph 0032, prior to a renal denervation treatment) and obtain a second signal indicating the second area measurement, a2, of the vessel (see paragraph 0050-0052 and 0078, sensor #204 can be used to obtain imaging data from the vessel, from which one or more measurement values associated with the vessel, such as cross section area can be determined and further compared);
a processor (see paragraph 0040 and 0058-0060, processor #140) configured to determine the […] in a blood vessel of the vessel based on the first and second signals (see paragraph 0058-0060, processor can measure changes in vessel diameter using the signals obtained by sensors #202,204 and any suitable measurement value within the vessel is contemplated by the processor), wherein the sensor comprises a variable inductor that produces wirelessly delivered area trace signal when remotely energized by an electric field (see paragraph 0062-0063, electrical connections between processing system and sensors where electrodes are positioned on patient to receive ECG signals).
Van der Horst does not specifically teach that a second signal indicating a second area measurement, a2, of the vessel is done after a patient maneuver. Van der Horst further does not specifically teach determining congestion in a blood vessel.
Gifford teaches making a first area measurement of the blood vessel before patient maneuver (see paragraph 0008, 0032-0037, 0043-0049: supplies perturbation testing and continued measurement where a baseline area signal is selected and retained immediately before leg raise) and making a second area measurement of the blood vessel after patient maneuver (see paragraph 0008, 0032-0037, 0043-0049: supplies perturbation testing and continued measurement where a baseline area signal is selected and retained immediately after leg raise). Gifford further teaches determining congestion in a blood vessel (see paragraph 0007, 0043, 0037: processor measures perturbation response for hypervolemic indication where hypervolemic assessment supplies a congestion indication).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Van der Horst with the teachings of Gifford because it would have resulted in the predictable result of basing diagnostic decisions and treatments on changes in IVC physical dimension to provide earlier warning of hypervolemia or hypovolemia and enabling the modulation of patient treatments to permit more stable long-term fluid management (Gifford: see abstract).
With respect to claim 51, all limitations of claim 50 apply in which Van der Horst further discloses further comprising at least one antenna for delivering the electric field and receiving the wireless area trace signal (see paragraph 0062-0063, various peripheral devices may include electrical connections between processing system and other components of system which may include antenna).
With respect to claim 52, all limitations of claim 50 apply in which Van der Horst further discloses wherein the implanted sensor is further configured for implantation in the inferior vena cava (IVC) to measure a cross-sectional area of the IVC and produce a wirelessly delivered area trace signal (see Fig. 1 and paragraph 0046, sensor #202 disposed along elongate member #170 which is inside of vessel #80; and see paragraph 0066, inferior vena cava).
With respect to claim 53, all limitations of claim 52 apply in which Van der Horst further discloses wherein the implanted sensor comprises a variable inductor having a flexible coil configured to extend around an inner periphery of the IVC in contact with the IVC wall, and the variable inductor produces the wireless area trace signal when remotely energized by an electric field (see paragraph 0062-0063, electrical connections between processing system and sensors where electrodes are positioned on patient to receive ECG signals).
With respect to claim 54, all limitations of claim 53 apply in which Van der Horst further discloses further comprising at least one antenna for delivering the electric filed and receiving the wireless area trace signal (see paragraph 0062-0063, various peripheral devices may include electrical connections between processing system and other components of system which may include antenna).
Claims 27, 34 and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Horst in view of Gifford as applied to claim 26 and 33 above respectively, and further in view of Toth (US 20180303414 A1; previously cited).
With respect to claim 27, all limitations of claim 26 apply in which Van der Horst further discloses wherein the identified signal shape comprises a square wave patten observed in an area trace obtained from the senor implanted in a patient inferior vena cave (IVC) (see paragraph 0062-0063, electrical connections between processing system and sensors where electrodes are positioned on patient to receive ECG signals; (see paragraph 0070-0071, signal shapes such as recognizable patterns).
Van der Horst and Gifford do not teach a Valsalva maneuver.
Toth teaches measuring a signal of a vessel after a patient maneuver (see paragraph 0051-0056, evaluating how the subject activity responds to stress test with sensors with data conveys in physiologic signals of vessel wall where stress test may include Valsalva maneuver).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Van der Horst and Gifford with the teachings of Toth to measure signal of a vessel after a patient maneuver and determine congestion because it would have resulted in the predictable result of comparing performance of performing a maneuver for treatment (Toth: see [0068]) of congestion of a blood vessel (Toth: [0015]-[0017]).
With respect to claim 34, all limitations of claim 33 apply in which Van der Horst further discloses implanting the sensor in the blood vessel (see Fig. 1 and paragraph 0046, sensor #202 disposed along elongate member #170 which is inside of vessel #80)
Van der Horst and Gifford do not teach wherein the patient maneuver is a Valsalva maneuver.
Toth teaches wherein the patient maneuver is a Valsalva maneuver (see paragraph 0051-0056, evaluating how the subject activity responds to stress test with sensors with data conveys in physiologic signals of vessel wall where stress test may include Valsalva maneuver).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Van der Horst and Gifford with the teachings of Toth to measure signal of a vessel after a patient maneuver and determine congestion because it would have resulted in the predictable result of comparing performance of performing a maneuver for treatment (Toth: see [0068]) of congestion of a blood vessel (Toth: [0015]-[0017]).
With respect to claim 46, all limitations of claim 33 apply in which Van der Horst and Gifford do not teach wherein prompting the patient to perform the maneuver comprises prompting the patient to perform a Valsalva or sniff-type maneuver.
Toth teaches wherein prompting the patient to perform the maneuver comprises prompting the patient to perform a Valsalva (see paragraph 0051-0056, evaluating how the subject activity responds to stress test with sensors with data conveys in physiologic signals of vessel wall where stress test may include Valsalva maneuver).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Van der Horst and Gifford with the teachings of Toth to measure signal of a vessel after a patient maneuver and determine congestion because it would have resulted in the predictable result of comparing performance of performing a maneuver for treatment (Toth: see [0068]) of congestion of a blood vessel (Toth: [0015]-[0017]).
With respect to claim 47, all limitations of claim 46 apply in which Toth further teaches wherein the maneuver is a Valsalva maneuver (see paragraph 0051-0056, evaluating how the subject activity responds to stress test with sensors with data conveys in physiologic signals of vessel wall where stress test may include Valsalva maneuver).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
