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 Rejections - 35 USC § 112
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.
In claim 1, line 10, “based on a right atrial pressure or central venous pressure” is inferentially including both pressures and it is unclear where they are coming from. Are they received from an element or determined as part of the method. In addition, “right atrial pressure or central venous pressure and the MAP” is unclear for the use of “or…and…” and what the “and” applies to. Does that mean using a right atrial pressure by itself is ok, or does it require using one of the RAP and CVP, and the MAP?
In claim 2, “is calibrated…” is in the passive voice and it is unclear if a method step is being positively recited/claimed. Method steps require active voice and it is suggested to state “further comprising calibrating the PPG…”.
Similarly, in claim 3, “is determined” is vague and in the passive voice.
In claims 4-9, the claims use passive voice (configured, trained, determined, corrected, filtered, and received) and are vague as it is unclear if a method step is being positively recited/claimed or if the limitations are intended/functional use recitations and only require the capability to be done that way. It is suggested to use active voice.
In claim 6, the claim is vague and conflicts with claim 1. Claim 1 receives the PTT from the PPG device, but claim 6 has it determined from an ECG signal. It is unclear what element is providing or determining the PTT and what elements or steps are included in the method. In addition, if a “calibrated” PPG is providing the PTT, why does an ECG need to be used?
Similarly, claim 15 has this problem.
In claim 10, line 15, “based on a right atrial pressure or central venous pressure” is inferentially including either pressure and it is unclear if they are being positively recited/claimed or are meant as functional/intended use recitations. No element has set forth to receive or determine these pressures. If the pressures are meant to be positively recited, it is suggested to first state an element that contains the pressures. If the pressures are meant as a functional/intended use recitation, then it is suggested put the pressures in an intended/functional use recitation or for the claim to set forth that they are received. In addition, “right atrial pressure or central venous pressure and the MAP” is unclear for the use of “or…and…” and what the “and” applies to. Does that mean using a right atrial pressure by itself is ok, or does it require using one of the RAP and CVP, and the MAP?
In claim 11, “a calibration factor” is vague and inferentially included. It is unclear if the factor is being positively or functionally recited.
In claim 12, line 3, “a first device” is vague and inferentially included.
In claim 14, “training data including…” is vague and inferentially included.
In claim 15, “an electrocardiogram signal” is vague and inferentially included. In addition, no element has been set forth to determine the PTT.
In claim 18, it is unclear if the pacemaker is being positively claimed or functionally recited. If the pacemaker is being positively recited, it is suggested to first state the system further comprises a pacemaker. If the pacemaker is being functionally recited, it is suggested for the claim to use intended use language such as “wherein the processor is configured to receive the heart rate from a pacemaker”.
In claim 19, lines 3-4, “based on a…received from a calibrated…” is vague and in the passive voice. In line 11, “based on a right atrial pressure or central venous pressure” is inferentially including either pressure and it is unclear where they are coming from. Are they received from an element or determined as part of the method. In addition, “right atrial pressure or central venous pressure and the MAP” is unclear fur the use of “or…and…” and what the “and” applies to. Does that mean using a right atrial pressure by itself is ok, or does it require using one of the RAP and CVP, and the MAP?
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 1-20 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 written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The subject matter which was not described in the specification is the determining of a stroke volume based on the PTT from the calibrated PPG device, in combination with the other steps and/or elements in the claims.
The claims have only repeated the words of the disclosure for how to determine a stroke volume based on the PTT from the calibrated PPG. The inventors had a general idea of performing this function/action but they did not possess the specific details of how this specific function/action is carried out when they filed the application.
The specification (e.g. paras. 6-8, 32, 50, etc.) uses the same words in the claim(s) for how to determine a stroke volume based on the PTT (or determine stroke volume at the minimum just using the PTT), from the calibrated PPG device, but go no further in describing how this is done. No equations or further guidance is given. In addition, it appears other factors are used in determining the stroke volume, such as using blood pressure and an electrocardiogram, but no guidance is given on how to use these other factors to determine stroke volume.
This rejection is related to written description.
Claims 1-20 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.
The subject matter which was not described in the disclosure is the determining of a stroke volume based on the PTT from the calibrated PPG device, in combination with the other steps and/or elements in the claims. The disclosure fails to state or teach one of ordinary skill in the art the exact way to determine a stroke volume based on the PTT from the calibrated PPG device, in combination with the other steps and/or elements in the claims.
Without this disclosure, one skilled in the art cannot practice the invention without undue experimentation because of the number of operational parameters in the process/apparatus and uncertainty of the nature of the invention as to how to determine a stroke volume based on the PTT from the calibrated PPG device.
Due to the lack of an enabling specification and lack of direction provided by the inventor for how to determine a stroke volume based on the PTT from the calibrated PPG device, several questions arise as to how to make and/or use the invention, such as:
How is stroke volume determined from the PTT?
How is stroke volume determined, at the minimum, from just the PTT alone (as the claims do not contain any other element or variable used to determine a stroke volume from the PTT)?
Are there any specific equations used to calculate stroke volume from the PTT? What are those equations?
Does using a calibrated PPG device influence how stroke volume is determined from the PTT?
Are other devices need to determine SV from the PTT, such as a blood pressure device or electrocardiogram?
Do these other devices need to be used in an equation or calculation to determine stroke volume from a PTT from a calibrated PPG device?
One example of many showing the state of the prior art, the level of ordinary skill and predictability, and necessary detail needed to enable someone skilled in the art to make and/or use a stroke volume determining system and method is patent number 8977348 to Su et al that describes calculating stroke volume from a measure of change in impedance between a peak and a bottom of the curve (e.g. col. 5, line 44 to col. 6, line 8) or through the well-known equation of using cardiac output and pulse rate to calculate stroke volume (e.g. SV=CO/PR, col. 7, lines 47-67, etc.).
Since there are numerous questions as to how the invention is made and/or used, since no amount of direction or guidance was presented, since other stoke volume systems and methods describe in detail how to determine a stroke volume, and/or since one skilled in the art cannot practice the invention without undue experimentation (as seen by the above questions) because of the number of operational parameters in the process/apparatus that are needed to determine a stroke volume based on the PTT from the calibrated PPG device, one skilled in the art to which it pertains is not enabled to make and/or use the invention of the subject matter presented in the claims.
This rejection is related to enablement.
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 an abstract idea without significantly more. The claim(s) recite(s) the mental concept or mathematical equation of receiving data (e.g. SBP, DBP, PTT, HR, etc.) to determine/calculate different parameters (SV, MAP, CO, etc.) to determine/calculate a system vascular resistance. This judicial exception is not integrated into a practical application because the combination of additional elements (e.g. memory, processor, and in the dependent claims a first device or machine learning model, etc.—Note that the method claims are not connected to any element) fails to integrate the judicial exception into a practical application. The additional elements are generically recited computer elements that do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. In addition, the first device or machine learning model are insignificant extra-solution activity that merely gather data for the abstract idea/mental concept/mathematical equation and is nothing more than an attempt to generally link the method or system to a particular technological environment. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered separately and in combination only store, calculate, and/or retrieve information and these are well-understood, routine, conventional computer functions as recognized by the court decisions listed in MPEP 2106.05.
The claims are directed to an abstract idea and/or the end result of the system/method, the essence of the whole, is a patent-ineligible concept. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they amount to a general computer performing a calculation. The claims are directed to an abstract idea, i.e. implementing the idea of receiving data (e.g. SBP, DBP, PTT, HR, etc.) to determine/calculate different parameters (SV, MAP, CO, etc.) to determine/calculate a system vascular resistance, such as may be done by a mental process, critical thinking, and/or paper and pencil, or done by a mathematical equation, with additional generic computer elements, or additional structure (e.g. memory, processor, and in the dependent claims a first device or machine learning model, etc.—Note that the method claims are not connected to any element) recited at a high level of generality that perform generic functions routinely used in the art, and do not add a meaningful limitation to the abstract idea because they would be routine in any computer implementation or in the relevant art. Thus, the recited generic computer components perform no more than their basic computer functions. These additional elements are well‐understood, routine and conventional limitations (see cited document(s)) that amount to mere instructions or elements to implement the abstract idea. In addition, the first device or machine learning model are insignificant extra-solution activity that merely gather data for the abstract idea/mental concept/mathematical equation and is nothing more than an attempt to generally link the method or system to a particular technological environment. In addition, the end result of the system/method, the essence of the whole, is a patent-ineligible concept. See the recent decisions by the U.S. Supreme Court, including Alice Corp., Myriad, and Mayo. In addition, the current claims are similar to other recent court decisions dealing with analyzing, comparing, and/or displaying data, such as Electric Power Group, Digitech, Grams, and Classen.
Based on the plain meaning of the words in the claim, the broadest reasonable interpretation of the claims (e.g. claim 10 having a memory and processor, and corresponding method claims 1 and 19, which are not connected to any element) is a system having a memory and processor, wherein the processor is programmed with executable instructions to perform the calculations/mental process/critical thinking. The claims do not impose any limits on how the data (e.g. SBP, DBP, PTT, HR, etc.) is received by the processor, and thus this step covers any and all possible ways in which this can be done, for instance by typing the information into the system, or by the system obtaining the information from another device. The claim also does not impose any limits on how the computations are accomplished, and thus it can be performed in any way known to those of ordinary skill in the art.
The calculations are simple enough to be practically performed in the human mind or through critical thinking. Note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation. Nor does the recitation of a processor in the claim negate the mental nature of this limitation because the claim here merely uses the processor as a tool to perform the otherwise mental process.
The memory and processor are recited so generically (no details whatsoever are provided other than that they are a memory and processor) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. In addition, the first device or machine learning model are insignificant extra-solution activity that merely gather data for the abstract idea/mental concept/mathematical equation and is nothing more than an attempt to generally link the method or system to a particular technological environment. It should be noted that because the courts have made it clear that mere physicality or tangibility of an additional element or elements is not a relevant consideration in the eligibility analysis, the physical nature of these computer components does not affect this analysis. See MPEP 2106.05(I) for more information on this point, including explanations from judicial decisions including Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 224-26 (2014).
Although the processor or claim limitations may fall under several exceptions (e.g., a mathematical concept-type abstract idea or a mental process-type abstract idea), there are no bright lines between the types of exceptions. See, e.g., MPEP 2106.04(I). Thus, it is sufficient for the examiner to identify that the limitations align with at least one judicial exception, and to conduct further analysis based on that identification.
The limitations of the claims are carried out by the processor and the memory. No element has been set forth to sense the data signals (e.g. SBP, DBP, PTT, HR, etc.), and the only additional element is the memory, where the processor performs the necessary software tasks so that the result of the abstract mental process is just data/determined systemic vascular resistance. The memory limitation represents extra-solution activity because it is a mere nominal or tangential addition to the claim. In addition, the first device or machine learning model are insignificant extra-solution activity that merely gather data for the abstract idea/mental concept/mathematical equation and is nothing more than an attempt to generally link the method or system to a particular technological environment. See MPEP 2106.05(g), discussing limitations that the Federal Circuit has considered to be insignificant extra-solution activity. Even when viewed in combination, the additional elements in this claim do no more than automate the mental processes (e.g., the mental computation of receiving data (e.g. SBP, DBP, PTT, HR, etc.) to determine/calculate different parameters (SV, MAP, CO, etc.) to determine/calculate a system vascular resistance, etc.), using the computer components as a tool. While this type of automation may improve the life of a practitioner/physician (by minimizing or eliminating the need for mentally computing metrics), there is no change to the computers and other technology that are recited in the claim as automating the abstract ideas, and thus this claim cannot improve computer functionality or other technology. See, e.g., Trading Technologies Int’l v. IBG, Inc., 921 F.3d 1084, 1093 (Fed. Cir. 2019) (using a computer to provide a trader with more information to facilitate market trades improved the business process of market trading, but not the computer) and the cases discussed in MPEP 2106.05(a)(I), particularly FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1095 (Fed. Cir. 2016) (accelerating a process of analyzing audit log data is not an improvement when the increased speed comes solely from the capabilities of a general-purpose computer) and Credit Acceptance Corp. v. Westlake Services, 859 F.3d 1044, 1055 (Fed. Cir. 2017) (using a generic computer to automate a process of applying to finance a purchase is not an improvement to the computer’s functionality). Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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/George R Evanisko/Primary Examiner, Art Unit 3792 6/27/26
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