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.
Claim(s) 1-20 is/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.
The term “normal” in claims 1, 14-15 is a relative term which renders the claim indefinite. The term “normal” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Per broadest reasonable interpretation, “normal” means “conforming to an expected standard, average, or rule.” However, what “standard, average, or rule” is considered “normal”? For example, is “normal” defined as the lack of “heart failure” since it is recited in the alternative? Thus, it is unclear how “normal” is defined. For examination purposes, the "normal" is interpreted as suitable/appropriate to any degree.
Claim(s) 2-13 is/are rejected as being dependent on claim 1.
Claim(s) 16-20 is/are rejected as being dependent on claim 14.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Based upon consideration of all of the relevant factors with respect to the claims as a whole, the claims are directed to non-statutory subject matter which do not include additional elements that are sufficient to amount to significantly more than the judicial exception because of the following analysis:
Claim 1 is drawn to a system which is within the four statutory categories (i.e., machine). Claim 14 is drawn to a method which is within the four statutory categories (i.e., method). Claim 15 is drawn to a device which is within the four statutory categories (i.e., machine).
Independent claim 1 (which is representative of independent claims 14-15) recites determine a respective one or more values for each of a plurality of physiological parameters, the plurality of physiological parameters comprising: fluid retention, wherein the respective one or more values for fluid retention correspond to a fluid retention state from a first set of states comprising a plurality of fluid retention states; and temperature, wherein the respective one or more values for temperature correspond to a temperature state from a second set comprising a plurality of temperature states; determine, using a probability model, one or more diagnostic states based on the respective values; determine a classification of a health condition of a patient as one of normal or heart failure based on the application of the diagnostic states to the probability model; determine, from the probability model, a probability score indicating a likelihood of the classification of the health condition being correct; and generate an output based on the health condition and the probability score.
Under its broadest reasonable interpretation, the limitations noted above, as drafted, covers certain methods of organizing human activity (i.e., managing personal behavior or relationships or interactions between people…following rules or instructions), but for the recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to collect data, analyze the data, and provide an output accordingly (i.e., health prediction and accuracy of prediction) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps as indicated supra. That is, other than reciting generic computer components (discussed infra), the claim amounts to managing personal behavior or relationships or interactions between people following rules or instructions. If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Claim 1 recites additional elements (i.e., A medical system comprising: an implantable medical device; an external device; a data server; and processing circuitry). Claim 14 recites additional elements (i.e., processing circuitry of a medical device system). Claim 15 recites additional elements (i.e., A computing device comprising processing circuitry). Looking to the specifications, a computing device having processing circuitry is described at a high level of generality (¶ 0043; ¶ 0188-0189), such that it amounts to no more than mere instructions to apply the exception using generic computer components. Also, although the claims add “an implantable medical device,” “an external device,” “a data server,” they are not used in the claims, which amounts to no more than mere instructions to implement an abstract idea on a computer, and only generally links the use of a judicial exception to a particular technological environment or field of use (i.e., computer technology), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Reevaluated under step 2B, the additional elements noted above do not provide “significantly more” when taken either individually or as an ordered combination. The use of a general purpose computer or computers (i.e., a computing device having processing circuitry) amounts to no more than mere instructions to apply the exception using generic computer components and does not impose any meaningful limitation on the computer implementation of the abstract idea, so it does not amount to significantly more than the abstract idea. Also, although the claims add “an implantable medical device,” “an external device,” “a data server,” they are not used in the claims, which amounts to no more than mere instructions to implement an abstract idea on a computer, and only generally links the use of a judicial exception to a particular technological environment or field of use (i.e., computer technology), which does not impose meaningful limits on the scope of the claim. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. The combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology and their collective functions merely provide a conventional computer implementation of the abstract idea. Furthermore, the additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generally linking the abstract idea to a particular technological environment or field of use, as the courts have found in Parker v. Flook; similarly, the current invention merely limits the claimed calculations to the healthcare industry which does not impose meaningful limits on the scope of the claim. Therefore, there are no limitations in the claims that transform the judicial exception into a patent eligible application such that the claims amount to significantly more than the judicial exception.
Dependent claims 2-13, 16-20 include all the limitations of the parent claims and further elaborate on the abstract idea discussed above and incorporated herein.
Claims 2-13, 16-20 further define the analysis and organization of data for the performance of the abstract idea and do not recite any additional elements. Thus, the claims do not integrate the abstract idea into a practical application and do not provide “significantly more.”
Although the dependent claims add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. These information characteristics do not change the fundamental analogy to the abstract idea groupings and, when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as the independent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-2, 5-9, 12-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. US 2021/0093254 A1 (hereinafter referred to as "Sarkar").
Regarding (previously presented) claim 1, Sarkar teaches a medical system comprising:
an implantable medical device (Sarkar: ¶ 0049, i.e., “medical device(s) 17 may include an implantable medical device (IMD)”);
an external device (Sarkar: ¶ 0049);
a data server (Sarkar: ¶ 0049); and
processing circuitry (Sarkar: ¶ 0058-0060) configured to:
determine a respective one or more values for each of a plurality of physiological parameters (Sarkar: ¶ 0134), the plurality of physiological parameters comprising:
fluid retention, wherein the respective one or more values for fluid retention correspond to a fluid retention state from a first set of states comprising a plurality of fluid retention states (Sarkar: ¶ 0037, i.e., “a decrease in impedance could reflect an increase in retained fluid”; ¶ 0076, i.e., “The one or more subcutaneous tissue impedance parameters may include one or more subcutaneous tissue impedance scores or fluid index values”; ¶ 0109, i.e., “the physiological parameters may include subcutaneous tissue impedance parameters”); and
temperature, wherein the respective one or more values for temperature correspond to a temperature state from a second set comprising a plurality of temperature states (Sarkar: ¶ 0109, i.e., “the physiological parameters may include…temperature”);
determine, using a probability model, one or more diagnostic states based on the respective values (Sarkar: ¶ 0068; ¶ 0103-0105; ¶ 0129);
determine a classification of a health condition of a patient as one of normal or heart failure based on the application of the diagnostic states to the probability model (Sarkar: ¶ 0040; ¶ 0116-0117);
determine, from the probability model, a probability score indicating a likelihood of the classification of the health condition being correct (Sarkar: ¶ 0115-0117; ¶ 0139); and
generate an output based on the health condition and the probability score (Sarkar: ¶ 0140; ¶ 0199).
Regarding (original) claim 2, Sarkar teaches the medical system of claim 1, wherein the processing circuitry is configured to determine the respective one or more values for fluid retention by determining one or more values for impedance (Sarkar: ¶ 0037, i.e., “a decrease in impedance could reflect an increase in retained fluid”; ¶ 0076, i.e., “The one or more subcutaneous tissue impedance parameters may include one or more subcutaneous tissue impedance scores or fluid index values”).
Regarding (currently amended) claim 5, Sarkar teaches the medical system of claim 1, wherein the output comprises the classification of the health condition (Sarkar: ¶ 0140; ¶ 0199).
Regarding (currently amended) claim 6, Sarkar teaches the medical system of claim 1, wherein the output comprises a risk level associated with the health condition (Sarkar: ¶ 0140; ¶ 0199).
Regarding (currently amended) claim 7, Sarkar teaches the medical system of claim 1, wherein the output comprises the probability score (Sarkar: ¶ 0140; ¶ 0199).
Regarding (currently amended) claim 8, Sarkar teaches the medical system of claim 1, wherein the processing circuitry is configured to determine the respective one or more values for each of the plurality of physiological parameters by collecting a respective one or more measurements for each of the respective one or more values for each of the plurality of physiological parameters at a pre-determined time of day (Sarkar: ¶ 0181, i.e., “processing circuitry 50 may control impedance measurements for determining respiration parameters to occur when certain conditions are satisfied, e.g., time of day, such as night”).
Regarding (currently amended) claim 9, Sarkar teaches the medical system of claim 1, wherein the respective one or more values for fluid retention are determined from one or more subcutaneous tissue impedance measurements (Sarkar: ¶ 0037, i.e., “a decrease in impedance could reflect an increase in retained fluid”; ¶ 0076, i.e., “The one or more subcutaneous tissue impedance parameters may include one or more subcutaneous tissue impedance scores or fluid index values”).
Regarding (currently amended) claim 12, Sarkar teaches the medical system of claim 1, wherein the processing circuitry is further configured to calibrate the respective one or more values for each of the plurality of physiological parameters (Sarkar: ¶ 0130, i.e., “Processing circuitry 80 may extract such features for each physiological parameter to encode amplitude and temporal characteristics with respect to particular temporal scales”).
Regarding (original) claim 13, Sarkar teaches the medical system of claim 12, wherein the processing circuitry is configured to calibrate the respective one or more values for each of the plurality of physiological parameters by determining a respective median value for each of the respective one or more values for each of the plurality of physiological parameters (Sarkar: ¶ 0130, i.e., “processing circuitry 98 may analyze a large set of time series data for each physiological parameter for time windows including the…median…Processing circuitry 80 may extract such features for each physiological parameter to encode amplitude and temporal characteristics with respect to particular temporal scales”).
Regarding (previously presented) claim 14, claim 14 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 14 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Regarding (previously presented) claim 14, claim 14 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 14 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Regarding (previously presented) claim 15, claim 15 recites substantially similar limitations analogous to those already addressed in claim 1, and thus, claim 15 is similarly analyzed and rejected in a manner consistent with the rejection of claim 1.
Regarding (new) claim 16, claim 16 recites substantially similar limitations analogous to those already addressed in claim 2, and thus, claim 16 is similarly analyzed and rejected in a manner consistent with the rejection of claim 2.
Regarding (new) claim 17, claim 17 recites substantially similar limitations analogous to those already addressed in claim 3, and thus, claim 17 is similarly analyzed and rejected in a manner consistent with the rejection of claim 3.
Regarding (new) claim 18, claim 18 recites substantially similar limitations analogous to those already addressed in claim 8, and thus, claim 18 is similarly analyzed and rejected in a manner consistent with the rejection of claim 8.
Regarding (new) claim 19, claim 19 recites substantially similar limitations analogous to those already addressed in claim 12, and thus, claim 19 is similarly analyzed and rejected in a manner consistent with the rejection of claim 12.
Regarding (new) claim 20, claim 20 recites substantially similar limitations analogous to those already addressed in claim 13, and thus, claim 20 is similarly analyzed and rejected in a manner consistent with the rejection of claim 13.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 3, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. US 2021/0093254 A1 (hereinafter referred to as "Sarkar") in view of U.S. Patent App. Pub. No. US 2017/0188875 A1 (hereinafter referred to as "BANET").
Regarding (currently amended) claim 3, Sarkar teaches the medical system of claim 1.
Yet, Sarkar does not explicitly teach, but BANET teaches, in the same field of endeavor, wherein the plurality of fluid retention states comprises a wet state and a dry state (BANET: ¶ 0085, i.e., “high fluid content (e.g. the patient is ‘wet’), and…low fluid content (e.g. the patient is ‘dry’)”).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the plurality of fluid retention states comprises a wet state and a dry state, as taught by BANET, within the system of Sarkar, with the motivation of “allowing better detection of certain disease states and/or management of chronic conditions such as CHF, diabetes, hypertension, COPD, and kidney failure” (BANET: ¶ 0047).
Regarding (currently amended) claim 10, Sarkar teaches the medical system of claim 1.
Yet, Sarkar does not explicitly teach, but BANET teaches, in the same field of endeavor, wherein the respective one or more values for fluid retention are determined from one or more tissue perfusion measurements (BANET: ¶ 0084-0085).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the respective one or more values for fluid retention are determined from one or more tissue perfusion measurements, as taught by BANET, within the system of Sarkar, with the motivation of “allowing better detection of certain disease states and/or management of chronic conditions such as CHF, diabetes, hypertension, COPD, and kidney failure” (BANET: ¶ 0047).
Claim(s) 4, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent App. Pub. No. US 2021/0093254 A1 (hereinafter referred to as "Sarkar") in view of U.S. Patent App. Pub. No. US 2020/0196943 A1 (hereinafter referred to as "Minor").
Regarding (currently amended) claim 4, Sarkar teaches the medical system of claim 1.
Yet, Sarkar does not explicitly teach, but Minor teaches, in the same field of endeavor, wherein the plurality of temperature states comprises a cold state and a warm state (Minor: ¶ 0080).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the plurality of temperature states comprises a cold state and a warm state, as taught by Minor, within the system of Sarkar, with the motivation “to assist in proper treatment regimens for patients at risk of heart failure hospitalizations based on the physiologic measurements performed” (Minor: ¶ 0022).
Regarding (currently amended) claim 11, Sarkar teaches the medical system of claim 1.
Yet, Sarkar does not explicitly teach, but Minor teaches, in the same field of endeavor, wherein the respective one or more values for temperature are determined from one or more subcutaneous tissue temperature measurements, endocardial tissue temperature measurements, or intramuscular tissue temperature measurements (Minor: ¶ 0080).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to include wherein the respective one or more values for temperature are determined from one or more subcutaneous tissue temperature measurements, endocardial tissue temperature measurements, or intramuscular tissue temperature measurements, as taught by Minor, within the system of Sarkar, with the motivation “to assist in proper treatment regimens for patients at risk of heart failure hospitalizations based on the physiologic measurements performed” (Minor: ¶ 0022).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2013/0116578 A1 teaches determining a heart failure risk score for the subject according to measured physiological parameters.
WO 2012/061153 A1 teaches monitoring temperature and impedance for evaluating the success of a treatment applied to tissue in a patient.
“Monitoring in the Intensive Care” teaches the significance of monitoring impedance and temperature as biological parameters for patients.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Huynh whose telephone number is (571)272-8317. The examiner can normally be reached on M-Th 8-5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMILY HUYNH/Primary Examiner, Art Unit 3683
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