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 .
Claim Objections
Claims 1, 3-4, 7, 12, 16-17, and 20 are objected to because of the following informalities:
In Claim 1, “a calculator included in the computer system for using the parametric measurements of the waveform to calculate a value for a blood flow volume in the patient’s vasculature” should read “a calculator included in the computer system for using the parametric measurements of the blood flow waveform to calculate a value for a blood flow volume in the patient’s vasculature”.
In Claim 3, “wherein the parametric measurements of the waveform include...” should read “wherein the parametric measurements of the blood flow waveform include...”.
In Claim 4, “wherein each blood flow volume is comparable to...” should read “wherein each calculated value of the blood flow volume is comparable to...”.
In Claim 7, “wherein the monitor evaluates respective changes in a diastolic pressure, ±Δpd, a systolic pressure ±Δps, and ±Δtr” should read “wherein the monitor evaluates respective changes in a diastolic pressure[[,]] ±Δpd, a systolic pressure ±Δps, and the time pulse rate ±Δtr”.
In Claim 12, “wherein the parametric measurements of the waveform sequentially include...” should read “wherein the parametric measurements of the blood flow waveform sequentially include...”.
In Claim 16, “a means for using the parametric measurements of the waveform” should read “a means for using the parametric measurements of the blood flow waveform”.
In Claim 17, “wherein the parametric measurements of the waveform sequentially include...” should read “wherein the parametric measurements of the blood flow waveform sequentially include...”.
In Claim 20, “wherein the evaluating means compares respective changes in a diastolic pressure, ±Δpd, a systolic pressure ±Δps, and ±Δtr” should read “wherein the evaluating means compares respective changes in a diastolic pressure[[,]] ±Δpd, a systolic pressure ±Δps, and the time pulse rate ±Δtr”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “a means having a readable medium with executable instructions stored thereon for directing the receiving means to collect parametric measurements of the blood flow waveform” in Claim 16.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim 16 is being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function
“means” is linked with the transitional word “for” and modified by the functional language “receiving audiometric signals from the vasculature of the patient”
“means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0020] as a pulse oximeter and equivalents thereof.
Claim 16 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function
“means” is linked with the transitional word “for” and modified by the functional language “using the parametric measurements of the waveform to calculate values for changes in the blood flow waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes”
“means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0012] and [0022] as a calculator function, program, or code within a computer system and equivalents thereof.
Claim 16 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function
“means” is linked with the transitional word “for” and modified by the functional language “evaluating changes in the blood flow waveform as indicators of the patient’s health condition”
“means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on Fig. 2, [0013], and [0021] as a computer system and equivalents thereof.
Claim 16 is also being interpreted under 35 U.S.C. § 112(f) as it:
Uses the nonce term “means” for the apparatus performing the specified function
“means” is linked with the transitional word “for” and modified by the functional language “presenting sequential values of parametric values on a visual display for use in evaluating the patient’s health condition”
“means” is not modified by sufficient structure, material, or acts for performing the claimed function.
This claim will be interpreted in accordance with the disclosure of the applicant on [0013] and [0020]-[0021] as computer-executable instructions to present data on a video display and equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 16-20 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue." Consistent with Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Wands factors continue to provide a framework for assessing enablement in a utility application or patent, regardless of technology area. See Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al., 89 FR 1563 (January 10, 2024). These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The Examiner notes that the Non-Patent Literature (NPL) to Brown et al (“A comparison of linear and logarithmic auditory tones in pulse oximeters”, hereinafter Brown, published in 2015) has been relied upon for evidence in this rejection.
Claim 1 recites “a pulse oximeter adapted to be non-invasively positioned against the body of a patient to receive audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform” and Claim 16 recites “a means adapted to be non-invasively positioned against the body of a patient for receiving audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform”, which is being interpreted under 35 U.S.C. § 112(f) as a pulse oximeter.
Regarding factor A), the scope of enablement provided to one skilled in the art by the disclosure is not commensurate with the scope of protection sought by the claims. Claim 1 requires a pulse oximeter, which is a device that senses red and infrared light (Brown, 2015), to be non-invasively positioned against the body of a patient and to receive audiometric signals from the vasculature of the patient, which are auditory signals. The examiner could not find an example of the broadest reasonable interpretation of the term “auditory signals” to mean anything other than sound, and in addition could not find an example of the broadest reasonable interpretation of “pulse oximeter” to mean anything other than an optical sensor. The specification does not explain this contradiction further. Instead it states “a computer system that receives audiometric signals from the pulse oximeter” ([0012]), which describes a different situation in which a pulse oximeter outputs auditory signals such as a tone instead of sensing auditory signals. One of ordinary skill in the art could not have made the entire scope of the claimed invention, specifically a pulse oximeter adapted to be non-invasively positioned against the body of a patient to receive audiometric signals from the vasculature of the patient, without undue experimentation. The interpretation of Claim 16 under 112(f) leads to a similar conclusion. Regarding factor B), Claims 1 and 16 (due to the interpretation under 35 U.S.C. § 112(f)) require the “means adapted to be non-invasively positioned against the body of a patient for receiving audiometric signals from the vasculature of the patient” to be explicitly a pulse oximeter that is capable of receiving auditory signals. Regarding factor C), there is no prior art that teaches a pulse oximeter adapted to receive audiometric signals from the vasculature of the patient —rather, pulse oximeters are adapted to output audiometric signals for example, where the pitch of the auditory tone changes with the level of oxygen saturation (See the “Introduction Section” of Brown, 2015). Regarding factor D), the level of one of ordinary skill in the art is not such that one of ordinary skill could easily conceive of how to sense auditory tones with a photodiode meant for sensing red and infrared light as are normally in pulse oximeters. Regarding factor E), one skilled in the art would not readily anticipate the effect of attempting to sense an audio signal with an optical detector, and therefore there is lack of predictability in the art. Regarding factor F), the applicant provides no direction on how to receive, i.e. detect, an audiometric signal using a pulse oximeter. Instead, the applicant discloses a computer system that receives audiometric signals from the pulse oximeter—this is a critical difference from the claimed limitation, as pulse oximeters are known to output audiometric signals, but never to sense them directly. Regarding factor G), the examiner has found no working examples of a pulse oximeter configured to detect audiometric signals. Regarding factor H), there would be an undue amount of necessary experimentation required for one of ordinary skill in the art to make a pulse oximeter detect audiometric signals based on the cursory content of the disclosure.
Based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).
Claims 2-9 and 17-20 are rejected by virtue of dependence on Claims 1 and 16, respectively.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “a monitor connected to the computer system to evaluate changes in the parametric measurements of blood flow volume as an indicator of the patient’s health condition”. There is insufficient antecedent for the limitation “the parametric measurements of blood flow volume”. While Claim 1 previously recites collecting parametric measurements of the blood flow waveform and thus implicitly changes in the parametric measurements of the blood flow waveform, there is no previous recitation of parametric measurements of a blood flow volume. For the purposes of substantive examination, the examiner is construing this claim limitation as “a monitor connected to the computer system to evaluate changes in the parametric measurements of blood flow waveform as an indicator of the patient’s health condition”.
Claims 2-9 are rejected by virtue of dependence on Claim 1.
Claim 7 recites the limitation " wherein the monitor evaluates respective changes in a diastolic pressure, ±Δpd, a systolic pressure ±Δps, and ±Δtr ". It is unclear if “a diastolic pressure” and “a systolic pressure” are referring to the previously recited diastolic pressure and systolic pressure recited in parent Claim 3, or different pressures. For the purposes of substantive examination, the examiner is construing this claim limitation as “wherein the monitor evaluates respective changes in [[a]] the diastolic pressure, ±Δpd, [[a]] the systolic pressure ±Δps, and ±Δtr”.
Claims 8-9 are rejected by virtue of dependence on Claim 7.
Claim 10 recites the limitation "identifying values for the parametric measurements from the blood flow volume waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function". There is insufficient antecedent basis for this limitation in the claim. There is no previous mention of a blood flow volume waveform. For the purposes of substantive examination and since there is previous mention of a blood flow waveform, the examiner is construing this claim limitation as “identifying values for the parametric measurements from the blood flow to calculate a value for a blood volume in the patient’s vasculature during each pulse of the patient’s heart muscle function”.
Claims 11-15 are rejected by virtue of dependence on Claim 10.
Claim 11 recites the limitation " wherein values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes". There is insufficient antecedent basis for “values of the blood flow volume” in the claim, even assuming Claim 10’s recitation of “a blood flow volume waveform” was proper. For the purposes of substantive examination, Claim 10 will be construed as explained above and Claim 11 will be construed as “wherein each calculated value of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes”.
Claims 12-15 are rejected by virtue of dependence on Claim 11.
Claim 16 recites “a means for using the parametric measurements of the waveform to calculate values for changes in the blood flow waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes”. There is insufficient antecedent basis for “the calculated values of the blood flow volume” in the claim. For the purposes of substantive examination, the examiner is construing this claim limitation as “a means for using the parametric measurements of the waveform to calculate values for a blood flow volume in the patient’s vasculature during each pulse of the patient’s heart muscle function wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes”.
Claims 17-20 are rejected by virtue of dependence on Claim 16.
Claim 20 recites the limitation " wherein the evaluating means compares respective changes in a diastolic pressure, ±Δpd, a systolic pressure ±Δps, and ±Δtr ". It is unclear if “a diastolic pressure” and “a systolic pressure” are referring to the previously recited diastolic pressure and systolic pressure recited in parent Claim 17, or different pressures. For the purposes of substantive examination, the examiner is construing this claim limitation as “wherein the evaluating means compares respective changes in [[a]] the diastolic pressure, ±Δpd, [[a]] the systolic pressure ±Δps, and ±Δtr”.
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 1-20 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 1 follows.
Regarding Claim 1, the claim recites a system for monitoring blood flow in a patient. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
collect parametric measurements of the blood flow waveform
using the parametric measurements of the waveform to calculate a value for a blood flow volume in the patient’s vasculature during each pulse of the patient’s heart muscle function
evaluate changes in the parametric measurements of blood flow volume as an indicator of the patient’s health condition
These limitations describe a mathematical calculation and/or 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 with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally collecting parametric measurements of the blood flow waveform, e.g. using pen and paper, mental observation, or using generic computing components to record data.
“Using the parametric measurements of the waveform to calculate a value for a blood flow volume in the patient’s vasculature during each pulse of the patient’s heart muscle function” is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally evaluate changes in the parametric measurements of blood flow volume as an indicator of the patient’s health condition, e.g. by qualitative thought and mental observation, using pen and paper, or using generic computing components to record data.
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 (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering. See MPEP 2106.05(g).
a pulse oximeter adapted to be non-invasively positioned against the body of a patient to receive audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a computer system having a readable medium with executable instructions stored thereon that direct the computer system to...
a calculator included in the computer system for...
a monitor connected to the computer system to...
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a pulse oximeter adapted to be non-invasively positioned against the body of a patient to receive audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform
a computer system having a readable medium with executable instructions stored thereon that direct the computer system to...
a calculator included in the computer system for...
a monitor connected to the computer system to...
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The pulse oximeter is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/10/2024 (“Structurally, a system for measuring the blood flow of a patient in accordance with the present invention preferably includes a pulse oximeter of any type well known in the pertinent art. The importance here is that it is well known a pulse oximeter will trace changes in blood pressure during a patient's heartbeat”).
The computer system, readable medium with executable instructions, calculator, and monitor are considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/10/2024 (See Fig. 2 and [0020]; under broadest reasonable interpretation, a computer system with a readable memory, calculating, and monitoring capabilities is a widely available commercial product).
Dependent Claims 2-9 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claim 7 also fails to add subject qualifying as significantly more to the abstract independent claim as it recites limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claim 7 also fails to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claim as it does not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Regarding Claim 10, the claim recites a method for monitoring blood flow in a patient. Thus, the claim is directed to a process, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
receiving audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform
collecting parametric measurements of the blood flow waveform
identifying values for the parametric measurements from the blood flow volume waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function
evaluating changes in the calculated parametric measurements as an indicator of the condition of the patient’s cardio vascular system
These limitations describe a mathematical calculation and/or 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 with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally receiving audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform, e.g. by hearing or using a generic transducer such as a stethoscope.
A human is capable of manually/mentally collecting parametric measurements of the blood flow waveform, e.g. visually, audibly, or with pen and paper.
“identifying values for the parametric measurements from the blood flow volume waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function” is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally evaluating changes in the calculated parametric measurements as an indicator of the condition of the patient’s cardio vascular system, e.g. by qualitative thought and mental observation, using pen and paper, or using generic computing components to record data.
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 (Step 2A, Prong Two).
There are no additional elements to analyze under this step.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
There are no additional elements to analyze under this step.
Regarding Claim 16, the claim recites a system for monitoring blood flow in a patient. Thus, the claim is directed to an apparatus, which is one of the statutory categories of invention (Step 1).
The claim is then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong One). The following limitations set forth a judicial exception:
directing the receiving means to collect parametric measurements of the blood flow waveform
calculate values for changes in the blood flow waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes
evaluating changes in the blood flow waveform as indicators of the patient’s health condition
These limitations describe a mathematical calculation and/or 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 with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner also notes that nothing from the claims suggests an undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps.
For example:
A human is capable of manually/mentally directing the receiving means to collect parametric measurements of the blood flow waveform, e.g. controlling a PPG sensor to take measurements.
“Calculating values for changes in the blood flow waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes” is a mathematical calculation that can be performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time.
A human is capable of manually/mentally evaluating changes in the blood flow waveform as indicators of the patient’s health condition, e.g. by qualitative thought and mental observation, using pen and paper, or using generic computing components to record data.
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 (Step 2A, Prong Two).
The following limitations amount to insignificant extra-solution activity to the judicial exception, e.g. mere data gathering and output. See MPEP 2106.05(g).
a means adapted to be non-invasively positioned against the body of a patient for receiving audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform
a means for presenting sequential values of parametric values on a visual display for use in evaluating the patient’s health condition
The following limitations amount to a recitation of the words "apply it" (or an equivalent)and/or nothing more than mere instructions to implement the abstract idea on a generic computer. See MPEP 2106.05(f).
a means having a readable medium with executable instructions stored thereon for...
a means for using the parametric measurements of the waveform to... (see the interpretation of this limitation under 35 U.S.C. § 112(f) above)
a means for evaluating changes in the blood flow waveform as indicators of the patient’s health condition (see the interpretation of this limitation under 35 U.S.C. § 112(f) above)
Therefore, these additional limitations do not integrate the judicial exception into a practical application.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, amounts to significantly more than the identified judicial exception (Step 2B):
The following limitations do not amount to significantly more than the abstract idea for substantially similar reasons applied in Step 2A, Prong Two.
a means adapted to be non-invasively positioned against the body of a patient for receiving audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform
a means for presenting sequential values of parametric values on a visual display for use in evaluating the patient’s health condition
a means having a readable medium with executable instructions stored thereon for...
a means for using the parametric measurements of the waveform to... (see the interpretation of this limitation under 35 U.S.C. § 112(f) above)
a means for evaluating changes in the blood flow waveform as indicators of the patient’s health condition (see the interpretation of this limitation under 35 U.S.C. § 112(f) above)
The following limitations is/are considered to be well-understood, routine, and conventional (WURC).
The pulse oximeter (i.e. a means adapted to be non-invasively positioned against the body of a patient for receiving audiometric signals from the vasculature of the patient, wherein the received signals are descriptive of a blood flow waveform as stated in the Claim Interpretation section above) is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/10/2024 (“Structurally, a system for measuring the blood flow of a patient in accordance with the present invention preferably includes a pulse oximeter of any type well known in the pertinent art. The importance here is that it is well known a pulse oximeter will trace changes in blood pressure during a patient's heartbeat”).
The means having a readable medium with executable instructions stored thereon is considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/10/2024 (See Fig. 2 and [0020]; under broadest reasonable interpretation, a computer system with a readable memory is a widely available commercial product)
The calculator and computer system (i.e. a means for using the parametric measurements of the waveform to calculate values for changes in the blood flow waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature which can be used for diagnostic purposes; a means for evaluating changes in the blood flow waveform as indicators of the patient’s health condition as stated in the Claim Interpretation section above) are considered to be well-understood, routine, and conventional based on statement from the applicant's specification filed 02/10/2024 (See Fig. 2 and [0020]; under broadest reasonable interpretation, a computer system with calculating capabilities is a widely available commercial product).
Dependent Claims 17-20 also fail to add subject matter qualifying as significantly more to the abstract independent claims as they merely further limit the abstract idea.
Dependent Claim 20 also fails to add subject qualifying as significantly more to the abstract independent claim as it recites limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above.
Dependent Claim 20 also fails to add subject matter integrating the judicial exception or qualifying as significantly more to the abstract independent claim as it does not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, Claims 1-20 are not patent eligible under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voss et al (US 20080183232 A1, cited in applicant’s IDS, hereinafter Voss).
Regarding Claim 1, Voss discloses a system (See all of Figs. 3-4) for monitoring blood flow in a patient ([0071], [0081]) which comprises:
a pulse oximeter (Element 200, Fig. 3; Element 300, Fig. 4; “An example of a photoplethysmographic tissue probe is, for example, a pulse oximeter”, [0080]) adapted to be non-invasively positioned against the body of a patient to receive audiometric signals (See Fig. 7; “FIG. 7 is a schematic illustration of an optical photoplethysmograph ("OP") signal”, [0042]; under broadest interpretation and in light of the 112(a) rejection above, the physiological processes that are detected by the waveform also create audiometric sounds) from the vasculature of the patient (“In one embodiment, the photoplethysmographic tissue probe is configured to communicate with or accept a body part, such as a finger, whereby one or more electromagnetic radiation emitters are disposed on one side of the tissue opposite one or more detectors to accept radiation from the emitters after passing through the tissue”, [0079]), wherein the received signals are descriptive of a blood flow waveform (“Although pulse oximeters are typically configured to measure oxygen levels in the blood, the temporal output of pulse oximeters provides an indication of the amount of blood flowing through the probed tissue”, [0081]);
a computer system having a readable medium (Elements 72-76, Fig. 4) with executable instructions stored thereon that direct the computer system to (“Programming for the signal processor 72 can be provided through media 80 transmitted to media reader 76, or through the network connection 78”, [0094]) collect parametric measurements of the blood flow waveform (Step 430, Fig. 8; “measurement(s) M includes at least one temporal measurement of blood flow through tissue, such as an OP signal from a pulse oximeter”, [0150]; this corresponds to the applicant’s specification which recites “all of the variables that are involved in defining a blood pressure waveform are hereinafter collectively referred to as "parametric measurements” in [0003]);
a calculator (A part of Element 72, Fig. 4/part of element 94, Fig. 3) included in the computer system for using the parametric measurements of the waveform to calculate a value for a blood flow volume in the patient’s vasculature during each pulse of the patient’s heart muscle function (Step 740, Fig. 8; “What is measured is the effect of the aortic pressure, which, according to the invention, comprises an optical photoplethysmograph ("OP") signal that indicates the volume of blood flow through tissue that is distant from the heart”, [0128]; “For example, stroke volume ("SV") is calculated for each beat by the following equation...”, [0143]); and
a monitor (A different part of Element 72, Fig. 4/part of element 94, Fig. 3) connected to the computer system (See Figs. 3-4) to evaluate changes in the parametric measurements of blood flow volume (Step 750, Figs. 8-9; see Equation 21 after [0255]) as an indicator of the patient’s health condition (“The performance of the cardiovascular system, including the heart, has characteristically been measured in terms of several different parameters, including the stroke volume and cardiac output of the heart”, [0002]).
Regarding Claim 2, Voss discloses the system of claim 1 wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature (“What is measured is the effect of the aortic pressure, which, according to the invention, comprises an optical photoplethysmograph ("OP") signal that indicates the volume of blood flow through tissue that is distant from the heart. Specifically, as the heart contracts, pressure builds in the aorta, forcing blood through the arteries.”, [0127]) which can be used for diagnostic purposes (The Examiner notes this clause is non-limiting functional language).
Regarding Claim 3, Voss discloses the system of claim 2 wherein the parametric measurements of the waveform include, in sequence:
a diastolic blood pressure measurement, pd (See Fig. 6, where diastolic pressure is the first data point on the waveform):
a systolic blood pressure measurement, ps (See Fig. 6, where systolic pressure follows the diastolic pressure point on the waveform): and
a time pulse rate (seconds / pulse), tr, for each pulse of the patient’s heart muscle function (See “time” on the X-axis of Fig. 6).
Regarding Claim 4, Voss discloses the system of claim 3 wherein each blood flow volume is comparable to the value of an area bounded by the blood flow waveform (See Fig. 7; an “OP” (optical photoplethysmograph) graph over time, which shows changes in blood volume over time, would show to total blood volume amount via an area under the OP curve) and a timeline underneath the blood flow waveform equal in value to the time pulse rate tr of the patient’s heart muscle function (See Fig. 7; under broadest reasonable interpretation, this graph shows an optical photoplethymography cycle which is a single pulse of the patients heart muscle function).
Regarding Claim 5, Voss discloses the system of claim 4 wherein the blood flow waveform is a trace of changes in blood pressure measurements in a sequence of diastolic-systolic–diastolic measurements during each pulse of the patient’s heart muscle function (See Fig. 6, where changes in blood pressure during sequence of diastolic-systolic–diastolic measurements during each pulse of the patient’s heart muscle function are graphed).
Regarding Claim 6, Voss discloses the system of claim 5 wherein the timeline for each pulse of the patient’s heart muscle function includes when the patient’s aortic valve opens and when it closes (See Fig. 6, where an entire cycle of the patient’s heart muscle function is graphed, which includes when the patient’s aortic valve opens and when it closes).
Regarding Claim 7, Voss discloses the system of claim 6 wherein the monitor evaluates respective changes in a diastolic pressure, ±Δpd, a systolic pressure ±Δps, and ±Δtr (“This information can then be used for various diagnostic purposes. By way of example, heart rate variation and blood pressure variation (possibly cardiac output variation), can be used to better detect hypovolemia prior to anesthesia-patients react differently to anesthetic (i.e. crash)”, [0114]).
Regarding Claim 8, Voss discloses the system of claim 7 wherein the change in each parametric measurement is evaluated in comparison with the change in every other parametric measurement during tr (See Fig. 6, wherein the blood flow waveform’s systolic, diastolic, and aortic pressure are graphed: this corresponds to the applicant’s specification, which states “all of the variables that are involved in defining a blood pressure waveform” in [0002]; “Block 430 stores information from previous heartbeats and compares measurements between heartbeats”, [0114]).
Regarding Claim 9, Voss discloses the system of claim 8 wherein indicators of a patient’s health condition include changes in the blood flow volume (See Step 819, Fig. 9; “a predetermined phenomenological model that is adapted to provide an estimate of a blood volume-time relationship proximate the heart and compute at least one physiologic characteristic associated with cardiac function based on the estimated blood volume-time relationship”, Abstract), based on changes in blood pressure measurements ±Δpd, and ±Δps (See Step 809, Fig. 9, which step 819 is based on), and changes in the time pulse rate ±Δtr (“This information can then be used for various diagnostic purposes. By way of example, heart rate variation and blood pressure variation (possibly cardiac output variation), can be used to better detect hypovolemia prior to anesthesia-patients react differently to anesthetic (i.e. crash)”, [0114]).
Regarding Claim 10, Voss discloses a method for monitoring blood flow in a patient which comprises the steps of: receiving audiometric signals (See Fig. 7; “FIG. 7 is a schematic illustration of an optical photoplethysmograph ("OP") signal”, [0042]; under broadest interpretation and in light of the 112(a) rejection above, the physiological processes that are detected by the waveform also create audiometric sounds; while the Examiner notes the broadest reasonable interpretation of “receiving audiometric signals” means auditory signals, the applicant’s specification makes clear that pulse oximeter signals are received in this method step. Therefore, for the purposes of compact prosecution, receiving the pulse oximeter signals as taught in Voss will be considered to anticipate this limitation) from the vasculature of the patient (“In one embodiment, the photoplethysmographic tissue probe is configured to communicate with or accept a body part, such as a finger, whereby one or more electromagnetic radiation emitters are disposed on one side of the tissue opposite one or more detectors to accept radiation from the emitters after passing through the tissue”, [0079]), wherein the received signals are descriptive of a blood flow waveform (“Although pulse oximeters are typically configured to measure oxygen levels in the blood, the temporal output of pulse oximeters provides an indication of the amount of blood flowing through the probed tissue”, [0081]);
collecting parametric measurements of the blood flow waveform (Step 410, Fig. 5; “measurement(s) M from Block 410 can be provided by systems 200 and 300”, [0100]; this corresponds to the applicant’s specification which recites “all of the variables that are involved in defining a blood pressure waveform are hereinafter collectively referred to as "parametric measurements”” in [0002]);
identifying values for the parametric measurements from the blood flow volume waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function (“Construct Temporal Arterial Pressure Signal (Block 710)”, [0149]; Step 740, Fig. 8; “What is measured is the effect of the aortic pressure, which, according to the invention, comprises an optical photoplethysmograph ("OP") signal that indicates the volume of blood flow through tissue that is distant from the heart”, [0128]; “For example, stroke volume ("SV") is calculated for each beat by the following equation...”, [0143]; this limitation is being interpreted in light of the 112(b) rejection above); and
evaluating changes in the calculated parametric measurements (Step 750, Figs. 8-9; see Equation 21 after [0255]; this limitation is being interpreted in light of the 112(b) rejection above) as an indicator of the condition of the patient’s cardio vascular system (“The performance of the cardiovascular system, including the heart, has characteristically been measured in terms of several different parameters, including the stroke volume and cardiac output of the heart”, [0002]).
Regarding Claim 11, Voss discloses the method of claim 10 wherein values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature (“What is measured is the effect of the aortic pressure, which, according to the invention, comprises an optical photoplethysmograph ("OP") signal that indicates the volume of blood flow through tissue that is distant from the heart. Specifically, as the heart contracts, pressure builds in the aorta, forcing blood through the arteries”, [0127]; this limitation is being interpreted in light of the 112(b) rejection above) which can be used for diagnostic purposes (The Examiner notes this clause is non-limiting functional language).
Regarding Claim 12, Voss discloses the method of claim 11 wherein the parametric measurements of the waveform sequentially include:
a diastolic blood pressure measurement, pd (See Fig. 6, where diastolic pressure is the first data point on the waveform):
a systolic blood pressure measurement, ps (See Fig. 6, where systolic pressure follows the diastolic pressure point on the waveform): and
a time pulse rate (seconds / pulse), tr, for each pulse of the patient’s heart muscle function (See “time” on the X-axis of Fig. 6).
Regarding Claim 13, Voss discloses the method of claim 12 wherein the blood flow waveform is bounded by a timeline underneath the blood flow waveform (See Fig. 7; an “OP” (optical photoplethysmograph) graph over time, which shows changes in blood volume over time, would show to total blood volume amount via an area under the OP curve) equal in value to the time pulse rate tr of the patient’s heart muscle function (See Fig. 7; under broadest reasonable interpretation, this graph shows an optical photoplethymography cycle which is a single pulse of the patients heart muscle function).
Regarding Claim 14, Voss discloses the method of claim 13 wherein the blood flow waveform is a trace of changes in blood pressure measurements in a sequence of diastolic-systolic–diastolic measurements during each pulse of the patient’s heart muscle function (See Fig. 6, where changes in blood pressure during sequence of diastolic-systolic–diastolic measurements during each pulse of the patient’s heart muscle function are graphed), and wherein the timeline for each pulse of the patient’s heart muscle function extends between the diastolic pressure at the beginning of the pulse and the diastolic pressure at the end of the pulse (See Fig. 7, where at least one entire cycle of the patient’s heart muscle function is from diastolic pressure at the beginning to diastolic pressure at the end).
Regarding Claim 15, Voss discloses the method of claim 14 wherein the change in each parametric measurement is evaluated in comparison with the change in every other parametric measurement during tr See Fig. 6, wherein the blood flow waveform’s systolic, diastolic, and aortic pressure are graphed: this corresponds to the applicant’s specification, which states “all of the variables that are involved in defining a blood pressure waveform” in [0002]; “Block 430 stores information from previous heartbeats and compares measurements between heartbeats”, [0114]), and wherein indicators of a patient’s health condition are based on changes in blood pressure measurements ±Δpd, and ±Δps, and changes in the time pulse rate ±Δtr (“This information can then be used for various diagnostic purposes. By way of example, heart rate variation and blood pressure variation (possibly cardiac output variation), can be used to better detect hypovolemia prior to anesthesia-patients react differently to anesthetic (i.e. crash)”, [0114]).
Regarding Claim 16, Voss discloses a system for monitoring blood flow in a patient which comprises:
a means (Element 200, Fig. 3; Element 300, Fig. 4; “An example of a photoplethysmographic tissue probe is, for example, a pulse oximeter”, [0080]) adapted to be non-invasively positioned against the body of a patient for receiving audiometric signals (See Fig. 7; “FIG. 7 is a schematic illustration of an optical photoplethysmograph ("OP") signal”, [0042]; under broadest interpretation and in light of the 112(a) rejection above, the physiological processes that are detected by the waveform also create audiometric sounds) from the vasculature of the patient (“In one embodiment, the photoplethysmographic tissue probe is configured to communicate with or accept a body part, such as a finger, whereby one or more electromagnetic radiation emitters are disposed on one side of the tissue opposite one or more detectors to accept radiation from the emitters after passing through the tissue”, [0079]), wherein the received signals are descriptive of a blood flow waveform (“Although pulse oximeters are typically configured to measure oxygen levels in the blood, the temporal output of pulse oximeters provides an indication of the amount of blood flowing through the probed tissue”, [0081]);
a means having a readable medium (Elements 72-76, Fig. 4) with executable instructions stored thereon for (“Programming for the signal processor 72 can be provided through media 80 transmitted to media reader 76, or through the network connection 78”, [0094]) directing the receiving means to collect parametric measurements of the blood flow waveform (Step 430, Fig. 8; “measurement(s) M includes at least one temporal measurement of blood flow through tissue, such as an OP signal from a pulse oximeter”, [0150]; this corresponds to the applicant’s specification which recites “all of the variables that are involved in defining a blood pressure waveform are hereinafter collectively referred to as "parametric measurements” in [0003]);
a means for using the parametric measurements of the waveform to calculate values for changes in the blood flow waveform in the patient’s vasculature during each pulse of the patient’s heart muscle function (Step 740, Fig. 8; “What is measured is the effect of the aortic pressure, which, according to the invention, comprises an optical photoplethysmograph ("OP") signal that indicates the volume of blood flow through tissue that is distant from the heart”, [0128]; “For example, stroke volume ("SV") is calculated for each beat by the following equation...”, [0143]; this limitation is being interpreted in light of the 112(b) rejection above) wherein the calculated values of the blood flow volume have an operational correlation with blood flow values in tissue throughout the vasculature (“What is measured is the effect of the aortic pressure, which, according to the invention, comprises an optical photoplethysmograph ("OP") signal that indicates the volume of blood flow through tissue that is distant from the heart. Specifically, as the heart contracts, pressure builds in the aorta, forcing blood through the arteries.”, [0127]) which can be used for diagnostic purposes (The Examiner notes this clause is non-limiting functional language);
a means for (A different part of Element 72, Fig. 4/part of element 94, Fig. 3) evaluating changes in the blood flow waveform as indicators of the patient’s health condition (“By way of example, heart rate variation and blood pressure variation (possibly cardiac output variation), can be used to better detect hypovolemia prior to anesthesia-patients react differently to anesthetic (i.e. crash)”, [0114]); and
a means for presenting sequential values of parametric values (“The analyzed information is then provided, as signal C, to Block 440, where one or more physiologic characteristics are displayed. In one embodiment, the physiologic characteristic(s) are visually displayed on a display, such as display 74 or 96”, [0113]) on a visual display (Element 96, Fig. 3; Element 74, Fig. 4) for use in evaluating the patient’s health condition (The Examiner notes this clause is non-limiting functional language).
Regarding Claim 17, Voss discloses the system of claim 16 wherein the parametric measurements of the waveform sequentially include:
a diastolic blood pressure measurement, pd (See Fig. 6, where diastolic pressure is the first data point on the waveform):
a systolic blood pressure measurement, ps (See Fig. 6, where systolic pressure follows the diastolic pressure point on the waveform): and
a time pulse rate (seconds / pulse), tr, for each pulse of the patient’s heart muscle function (See “time” on the X-axis of Fig. 6).
Regarding Claim 18, Voss discloses the system of claim 17 wherein each blood flow waveform is bounded by a timeline underneath the blood flow waveform (See Fig. 7; an “OP” (optical photoplethysmograph) graph over time, which shows changes in blood volume over time, would show to total blood volume amount via an area under the OP curve), wherein the timeline is equal in value to the time pulse rate tr of the patient’s heart muscle function (See Fig. 7; under broadest reasonable interpretation, this graph shows an optical photoplethymography cycle which is a single pulse of the patients heart muscle function).
Regarding Claim 19, Voss discloses the system of claim 18 wherein the blood flow waveform is a trace of changes in blood pressure measurements in a sequence of diastolic-systolic–diastolic measurements during each pulse of the patient’s heart muscle function See Fig. 6, where changes in blood pressure during sequence of diastolic-systolic–diastolic measurements during each pulse of the patient’s heart muscle function are graphed), and wherein the timeline for each pulse of the patient’s heart muscle function extends between the diastolic pressure at the beginning of the pulse and the diastolic pressure at the end of the pulse (See Fig. 7, where at least one entire cycle of the patient’s heart muscle function is from diastolic pressure at the beginning to diastolic pressure at the end).
Regarding Claim 20, Voss discloses the system of claim 19 wherein the evaluating means compares respective changes in a diastolic pressure, ±Δpd, a systolic pressure ±Δps, and ±Δtr, which are each evaluated in comparison with one another during tr (“Determine the Extent of Pressure Pulse (Block 720); Determine Heart Rate (Block 730)”, [0149]) as indicators of a patient’s health condition (“Calculate Stroke Volume (Block 740); and Compute Cardiac Output (Block 750)”, [0149]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Huang et al (US 20160081561), which discloses a method for monitoring blood flow in a patient which comprises the steps of: receiving audiometric signals (See Fig. 2).
See Saito et al (US 20110125033 A1), which discloses which discloses a method for monitoring blood flow in a patient which comprises the steps of: receiving audiometric signals (See Figs. 1-2).
See Kimura (US 20050065432 A1).
See Addison et al (US 20140316286 A1).
See Sathya et al (US 20190200879 A1).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791