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 .
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.
Priority
The instant application is filed as a Continuation (CON) of US App. No. 17/101945, currently patent No. 12,178,566, filed 11/23/2020. The instant application was filed 11/20/2024, before the Notice of Allowability was filed on 12/11/2024 and is considered to be co-pending and therefore the instant application is granted an effective filing date of 11/23/2020. However, it appears that this application should have been filed as a divisional application (DIV).
This application, although filed as a CON currently, discloses and claims similar subject matter disclosed in prior Application No. 17/101,945, filed 11/23/2020, appears to claim only subject matter directed to an invention that is independent and distinct from that claimed in the prior application, and names the inventor or at least one joint inventor named in the prior application. Accordingly, this application constitutes a divisional application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/26/2024 and 12/10/2025 was filed after the mailing date of the application on 11/26/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 claims recite a series of steps to be completed by sensors of a medical system (electrodes), sensing circuitry, processing circuitry, data gathered from said electrodes and sensing circuitry, and a display to output the results of the processing circuitry. This judicial exception is not integrated into a practical application because the acquiring step is recited at a high level of generality (i.e., as a general means of gathering values to be used in accuracy determination) and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no inventive concept in the claim. See below for a 2 Step Analysis of the claims.
With respect to step 1: Are the claims directed to a statutory category?
Yes. The claims recite a method to be completed by a processing system. A method claim set is eligible at step 1.
With respect to Step 2A, Prong 1: Is a Judicial Exception Recited?
Yes. The claims recite the limitations of “detecting by processing circuitry” and “correcting by processing circuitry” an inaccuracy in data. These limitations, as drafted, are a process that, under its broadest reasonable interpretation covers performance of the limitation in the mind but for the recitation of generic processing components. That is, other than reciting “a processing circuitry”, nothing in the claimed element precludes the step from being practically performed in the mind. For example, except for the “processing circuitry” language, the claim encompasses a user being able to detect and correct inaccurate data. The mere nominal recitation of a generic processing circuitry does not take the claim limitation out of the mental processing grouping. Therefore, the claim recites a mental process/abstract idea.
With respect to Step 2A, Prong 2: Is the process integrated into a practical application?
No. The claim recites the following additional elements: sensors of a medical system comprising electrodes, sensing circuitry, and a display device. The above limitations appear to be directed to mental processes, where the limitations concern only data collection, data analysis, recording the results of the data analysis, and displaying data. The capturing, sensing, and generating of data is recited at a high level of generality (i.e., as a general means of gathering values to be used in the correcting step) and amounts to mere data gathering, which is a form of insignificant extra-solution activity. The correction step is also recited at a high level of generality, and merely is feedback from the detecting step and an adjustment of a mathematical value. Further, the generating step for display of data on a display device, where displaying data is a form of insignificant extra-solution activity. Each of the additional limitations is no more than mere instructions to apply the exception using generic computing components (processing circuitry and sensing circuitry). The combination of these additional elements is no more than mere instructions to apply the exception using a generic computing component. Accordingly, even in combination, these 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. The display on the display device is not actually used for other activity. The claims are therefore directed to an abstract idea.
With respect to Step 2B: Do the claims provide an inventive concept?
No. As discussed with respect to Step 2A Prong 2, the additional elements in the claim amount to no more than mere extra-solution activity to apply the exception using generic computing components. The same analysis here applies in step 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
Since there needs to be a re-evaluation of the data collection step and adjustment step in Step 2B, further re-evaluation as to whether the recitations are more than what is well-understood, routine, conventional activity in the field is needed. There is no indication that the processing and sensing circuitry are anything other than a generic, off-the-shelf computer component, and the Symantec, TLI, and OIP Techs. court decisions cited in MPEP 2106.05(d)(II) indicate that mere collection or receipt of data over a network is a well-understood, routine, and conventional function when it is claimed in a merely generic manner (as it is here). Accordingly, a conclusion that the collecting step is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Furthermore, the ability to adjust a value with feedback is seen as well-understood, routine and conventional as different control structures using off-the-shelf computers integrate feedback into their systems.
For these reasons, there is no inventive concept in the claim, and thus it is ineligible.
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)(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.
Claims 1, 8, 11, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chakravarthy (US 2020/0357519), herein after “Chakravarthy”.
The applied reference has a common assignee (Medtronic) with the instant application. Based upon the earlier effectively filed date of the reference (April 17, 2020), it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Chakravarthy teaches
“A method (p.[0012,0104]) comprising: capturing, by one or more sensors (58) of a medical system (abstract), at least one signal indicating one or more patient physiological parameters (p.[0045, 0049]);”
“sensing, by at least one electrode of the one or more sensors, an impedance of a portion of a patient body proximate to the at least one electrode (p.[0077]);”
“generating, by sensing circuitry coupled to the one or more sensors, data corresponding to the one or more patient physiological parameters (p.[0049]);”
“detecting, by processing circuitry of the medical system, an inaccuracy in the data corresponding to the one or more patient physiological parameters based upon at least the sensed impedance of the portion of the patient body (p.[0077], inaccuracy being noisy data);”
“correcting, by the processing circuitry of the medical system, at least a portion of the inaccuracy in the data corresponding to the one or more patient physiological parameters (p.[0077], where filtering inaccurate data is a form of correction of the data)”
“generating, for display on a display device, output data indicating the inaccuracy in the data corresponding to the one or more patient physiological parameters (p.[0078]).”
Regarding claim 8, the limitations of claim 1 are taught as described above. Chakravarthy teaches “invalidating the data corresponding to the one or more patient physiological parameters if the correction is unsuccessful at correcting the at least a portion of the inaccuracy in the data corresponding to the one or more patient physiological parameters (p.[0077] where invalidating the data is discarding periods of time where filtered data is not enough to remove the highly varying levels of input impedance from noise in the ECG data).”.
Regarding claim 11, Chakravarthy teaches that the method of claim 1 can be performed by a non-transitory computer-readable medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to execute the same method of claim 1 in p.[0139]. Claim 11 is taught by the rejection of claim 1 as described above.
Regarding claim 18, the limitations of claim 11 are taught as described above. Chakravarthy teaches that the method of claim 8 can be performed by a non-transitory computer-readable medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to execute the same method of claim 8 in p.[0139]. Claim 18 is taught by the rejection of claim 8 as described above.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 14 rejected under 35 U.S.C. 103 as being obvious over Chakravarthy in view of Anderson (US Patent No. 10,517,540 B2), herein after “Anderson”.
Regarding claim 4, the limitations of claim 1 are taught as described above. Chakravarthy does not teach "wherein detecting an inaccuracy in the data corresponding to the one or more patient physiological parameters comprises: comparing the data corresponding to the one or more physiological parameters with respective detection criteria for migration or rotation of the one or more sensors; and computing a detection score indicating whether the one or more sensors migrated or rotated based on the comparison."
However, Anderson teaches in an analogous electrosurgical device with sensors: “comparing the data corresponding to the one or more physiological parameters with respective detection criteria for migration or rotation of the one or more sensors (p.[0045], updating and modifying TFM, which is based on patient physiological parameters)”, “computing a detection score indicating whether the one or more sensors migrated or rotated based on the comparison (p.[0045])”.
It would have been obvious to one of ordinary skill in the art at the time of filing to have utilize the modification of criterion as taught by Anderson with the sensing and signal processing of Chakravarthy so to provide a combined system that functions to modify detection criterion (such as patient data) when there is a detected shift in a lead or sensor. As suggested in Anderson (p.[0040]), doing so allows for the correction of the detection criteria to prevent for noise, unreliable signals, or faulty data and produces predictable results. Chakravarthy, Anderson, and the claimed invention are considered analogous pieces of art because they are in the same field of electrosurgical devices capable of conditioning patient data.
Regarding claim 14, the limitations of claim 11 are taught as described above. Chakravarthy teaches that the method of claim 4 can be performed by a non-transitory computer-readable medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to execute the same method of claim 4 in p.[0139]. Claim 14 is taught by the rejection of claim 4 as described above.
Claims 6 and 16 rejected under 35 U.S.C. 103 as being obvious over Chakravarthy in view of Anderson and Meger (US 2011/0112442).
Regarding claim 6, the limitations of claim 4 are taught as described above. Neither Chakravarthy nor Anderson teach "communicating the detection score to a remote computer as a confidence level for a medical condition alert for the patient" but Meger does in an analogous monitoring medical device. Meger teaches “communicating the detection score to a remote computer as a confidence level for a medical condition alert for the patient“ in p.[0098] which describes that all processed data (detection score) can be sent to a remote site (remote computer) for further analysis and clinical work up, including a confidence level for each clinical parameter detected, (p.[0330,0355,0361]) where the clinical parameter can be a medical condition (p.[0361]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the confidence level of Meger in Chakravarthy/Anderson. As stated in Meger p.[0361], "This technique helps prevent false alerts" and produces predictable results of improving accuracy of medical condition alerts.
Regarding claim 16, the limitations of claim 14 are taught as described above. Chakravarthy teaches that the method of claim 6 can be performed by a non-transitory computer-readable medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to execute the same method of claim 6 in p.[0139]. Claim 16 is taught by the rejection of claim 6 as described above.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being obvious over Chakravarthy in view of Anderson and Cheng (US 2020/0345309).
Regarding claim 7, the limitations of claim 4 are taught as described above. Chakravarthy/Anderson does not teach "withholding display, storage, or communication of the data corresponding to the one or more patient physiological parameters based on the detection of the inaccuracy in the data" but Cheng does in an analogous medical data detection device. Cheng teaches “withholding display, storage, or communication of the data corresponding to the one or more patient physiological parameters based on the detection of the inaccuracy in the data” in p.[0005] which states that "The processing circuitry is further configured to withhold an indication of an asystole episode for the patient based on a determination that at least one of the plurality of false asystole detection criteria is satisfied." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Cheng in Chakravarthy/Anderson to arrive at the claimed invention. As stated in Cheng p.[0004], withholding the indication "may advantageously enable improved accuracy in the identification of true asystole and, consequently, better evaluation of the condition of the patient." and produces predictable results of better patient outcomes.
Regarding claim 17, the limitations of claim 14 are taught as described above. Chakravarthy teaches that the method of claim 7 can be performed by a non-transitory computer-readable medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to execute the same method of claim 7 in p.[0139]. Claim 17 is taught by the rejection of claim 7 as described above.
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being obvious over Chakravarthy in view Cheng.
Regarding claim 9, the limitations of claim 8 are taught as described above. Chakravarthy does not teach "rejecting a medical condition prediction rendered by a medical device when, for that prediction, the medical device uses, at least in part, the data corresponding to the one or more patient physiological parameters based on the detection of the inaccuracy in the data" but Cheng does in an analogous medical data detection device. Cheng teaches “rejecting a medical condition prediction rendered by a medical device when, for that prediction, the medical device uses, at least in part, the data corresponding to the one or more patient physiological parameters based on the detection of the inaccuracy in the data” in Fig. 6 that the system of Cheng can determine if a medical prediction is false (a false asystole) based on the detection of inaccurate data (decay noise, energy pattern) in the sample, where rejecting a medical condition is considered to be synonymous to deeming it false under broadest reasonable interpretation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Cheng in Chakravarthy to teach rejecting a medical prediction in view of inaccurate detection of data. As stated in Cheng (p.[0037]), rejecting (or deeming false) asystole data "may advantageously enable improved accuracy in the identification of true asystole and, consequently, better evaluation of the condition of the patient." and produces predictable results of better identification of accurate data.
Regarding claim 19, the limitations of claim 18 are taught as described above. Chakravarthy teaches that the method of claim 9 can be performed by a non-transitory computer-readable medium comprising program instructions that, when executed by processing circuitry, cause the processing circuitry to execute the same method of claim 9 in p.[0139]. Claim 19 is taught by the rejection of claim 9 as described above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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