DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 5/26/2026 have been fully considered but they are not persuasive.
Regarding the 35 USC 101 rejection of the claims, Applicant argues on page of the response “Unlike a clinician observing data, the independent claims expressly require acquisition of physiologic signals via a signal receiver circuit and determination of a patient metric from those signals over a defined first time period prior to therapy. These operations cannot practically be performed in the human mind because they require processing of time-based, sensor-derived physiologic signals and correlating data from multiple physiologic modalities, such as heart sound and respiration.” The Examiner respectfully disagrees. As noted in the rejection, the step of acquiring physiologic signals via a signal receiver circuit is an additional element (and not part of the abstract idea) that only amounts to the insignificant, extra-solution activity of data gathering. The step of determining a patient metric from these signals are part of the abstract idea and, due to the breadth of the claim, only amounts to decision making base don patient data that a skilled clinician can perform in their mind and/or wit the aid of pen and paper.
Applicant’s amendment regarding the inclusion of Claim 22 that requires enabling or disabling CRT or MSP therapy based on the predicted response does overcome the 35 USC 101 rejection as it provides a practical application of device control based on the results of the abstract process. This limitation is not found in Claim 21 so claim 21 and some of its dependents are likewise rejected under 35 USC 101, see rejection below.
Applicant further argues on p. 9 of the Response, “Claim 5 requires, among other things, that the assessment circuit is configured to determine the patient metric as a function of the S3 information over the S1 information and the RSBI information. Claim 5. Claim 13 requires similar limitations. This limitation expressly recites a specific ratio-based algorithmic process embedded in the operational logic of the assessment circuit, constituting a specific data processing technique that determines how the assessment circuit executes its core decision logic and integrates any abstract idea into a practical application. Enfish, 822 F.3d at 1339.” The Examiner respectfully disagrees. Claim 5 only requires making a decision based on simple division/ratio (S3 information over S1 information) and RSBI information. The assessment circuit is so generically claimed that it is a generic computer processor and such Claim 5 is the generic computer implementation of abstract concepts that can be performed mentally by a clinician.
On pp. 9-10 of the Response, Applicant argues the process prevents unnecessary high-power mode activation in a finite-battery ambulatory devoice. However, Claims 1 and 21 do not include limitations commensurate in scope with the arguments. Namely, the claims do not require any action base don the decision making that would alter battery consumption. However, Claim 22 dos by enabling or disabling CRT or MSP therapy. Therefore, claims 1 and 21 are still rejected under 35 USC 101 while claim 22 is not.
Regarding Claim 23, the Examiner notes the enabling or disabling of the CRT or MSP a claimed does not overcome the 101. It is different from claim 22 in that claim 22 requires the enabling/disabling to be based on the determination. Claim 23 does not require this and instead simply adds on a disabling or enabling of CRT or MSP, regardless of the decision. The stimulation in this case insignificant, extra-solution activity that is broadly applied during the process and simply is performed in order to gather data for the mental analysis step (see example c, MPEP §2106.04.(d)(2)).
Regarding the 102 rejection of the claims, Applicant argues on pg. 12 of the response, “The claimed requirement that the first time period is prior to the CRT or MSP therapy is dispositive: Zhang operation occurs during ongoing CRT therapy, not prior to it. The cited portions of Zhang require active pacing parameter variation and evaluation of resulting heart sound changes during ongoing therapy, and therefore cannot determine a predicted response to the CRT or MSP therapy at issue based on physiologic information from a first time period prior to that therapy. In contrast, the present claims require determining a predicted response based on physiologic information obtained during a first time period prior to the CRT or MSP therapy for which response is being predicted, without relying on therapy-induced changes produced by varying pacing parameters during an optimization routine, which is neither disclosed nor suggested in Zhang.” The Examiner respectfully disagrees.
Applicant’s claim 1 states “determine a patient metric using the received physiologic information from a first time period”. Nothing in the claims states that some form of therapy could not be delivered during this time period. Claim 1 then states “determine an indication of a predicted response to at least one of cardiac resynchronization therapy (CRT) or multi-site pacing (MSP ) therapy based on the determined patient metric”. Again, nothing in this statement precludes any prior application of a therapy. The terms CRT or MSP therapy, given their broadest reasonable interpretation, amount to a set of parameters that provide a CRT response or are delivered in a MSP configuration. For instance, a first CRT therapy would involve parameters having a first AV delay. A patient response can be detected, parameters reassessed and then adjusted. The application of an adjusted AV delay would therefore amount to a second CRT therapy. This is a typical closed-loop type response in pacing in that during a first time period, a first CRT is delivered; responses are sensed during that first time period; parameters are adjusted; and, during a second time period after the first time period, a new CRT therapy with adjusted parameters is delivered. This meets the claim requirement of “wherein the first time period is prior to the CRT or MSP therapy”.
Applicant argues on p. 13 of the Response that claim 5 requires both heart sound and respiration information. However, as note din the Non-Final Rejection, Claim 1 states “at least one of heart sound information or respiration information” clearly setting forth the broadest, reasonable interpretation of the claim as only requiring one of heart sound or respiration. Thus any dependent claim, given this BRI, would only require one of them. Claim 5 does not state “wherein including at least one of heart sound information or respiration information includes the S3 information over the S1 information and the RSBI information” or some variant thereof. Currently, the claim limitations are claimed separately from the “including” language of Claim 1 and if, as in claim 1, only heart sound or only RSBI is chosen as the option, the other would not be needed in the dependent claim. The interpretation and associated rejections are being maintained.
Applicant argue son pp. 13-14 of the response, “Gillberg does not receive or process sensor-derived physiologic signals collected over a defined pre-therapy time period and used to compute a patient-specific metric, but instead relies on model-based simulation using patient characterization inputs, which are not tied to any temporally bounded physiologic signal acquisition or metric determination as recited in the claims. Gillberg contains no pre-therapy monitoring window, no patient metric derived from measured physiological signals over such a window, and no threshold comparison of a signal-derived metric to predict binary CRT or MSP therapy response before therapy initiation.” The Examiner respectfully disagrees.
First, the Examiner notes Applicant is arguing a claim scope that is not currently reflected in the claims. Claim1 does not require a pre-therapy monitoring window nor does the claim require predicting a binary response as argued. Additionally, while the preamble of Claim 21 mentions “pre-therapy screening”, the body of the claim does not define any pre-therapy window as argued and does not require a binary CRT or MSP therapy response. The claims scope only requires gathering data and then adjusting therapy to be delivered after the data is gathered base don an analysis of the data. Gilliberg discloses this process in that Gilliberg discloses obtaining “patient characterization data” (par. [0035]) wherein the data can include heart sounds (par. [0037]) and that this “patient characterization data” is used to create a model that is then used to predict a response and provide therapy modification based on the predicted response(par. [0031, 0041, 0165, 0191]). The application of the adjusted therapy occurs after the initial data collection and thus meets the limitation of predicting a response to therapy prior to an actual application of the new therapy.
Applicant’s arguments with respect to Zhou, namely that the combination of Gillberg and Zhou fail to provide the missing pre-therapy monitoring period have been considered but are not persuasive in that the argued scope is not commensurate in scope with the claim limitations. The claims do not preclude a therapy from being provided during the first time period and instead simply state that an adjusted or new therapy is applied after a first time period in which data is gathered (this time period could have another therapy applied during it).
The rejections are therefore maintained.
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 1-16, 21, 23 and 24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1
The claims are drawn to products (Claims 1-8, 21, 23 and 24) and processes (Claims 9-16)
Step 2A, Prong 1
Claims 1, 9 and 21 recite the steps of “determining a patient metric using the received physiologic information”; “determine an indication of a predicted response to at least one of cardiac resynchronization therapy (CRT) or multi-site pacing (MSP) therapy based on the determined patient metric, wherein the first time period is prior to the CRT or MSP therapy”; and “provide the determined indication of the predicted response to a user or process”. These steps are so broadly claimed that they could amount to a clinician looking at a set of data (such as heart sound data); and predict a level of response to therapy, such as CRT therapy, if the heart sounds indicate therapy would be needed. The predicted response could simply be “they will respond positively” or “they will respond negatively”. The last step of providing the indication could be a mental acknowledgement (which is a process) or could be verbal or written communication to a user.
Step 2A, Prong 2
Claims 1, 9 and 21 do not include any additional elements that amount to integration of the abstract idea into a practical application. The claims include the additional elements of a receiver circuit and an assessment circuit. The receiver circuit amounts to the insignificant extra-solution activity of data gathering. The assessment circuit amounts to generic computer implementation of the abstract idea. Insignificant, extra-solution activity and generic computer implementation do not amount to integration of the abstract idea into a practical application.
Step 2B
Claims 1, 9 and 21 do not include any additional elements that amount, alone or in combination, to significantly more than the abstract idea itself. he claims include the additional elements of a receiver circuit and an assessment circuit. The receiver circuit amounts to the insignificant extra-solution activity of data gathering. The assessment circuit amounts to generic computer implementation of the abstract idea. Insignificant, extra-solution activity and generic computer implementation, alone or in combination, do not amount to significantly more than the abstract idea itself.
Claims 2 and 10 only generically expands the abstract idea to another technological environment or field of use.
Claims 3, 5, 8, 11, 13 and 16 only further define the abstract idea.
Claims 4, 6, 7, 12, 14, 15 and 24 only further define the data gathering steps.
Claim 23 only generically links the abstract idea to another technological environment of field of use (ambulatory devices) and only recites therapy in a way that amounts to insignificant, extra solution activity in that is simply sets up the environment in which the data is gathered. The therapy is not tied to the result of the determination (see MPEP §2106.04(d)(2), example c).
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 24 is 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 21, from which claim 24 depends, only requires “at least one of heart sound information or respiration information”. However, claim 24 requires both RSBI and S1 or S3 information, contradicting claim 24 that only requires one of the types. To overcome this rejection, the Examiner suggests amending Claim2 4 to state “wherein the at least one of heart sound information or respiration information requires both the heart sound information and the respiration information” or some variant thereof. The claims are currently unclear as to what combination of information Applicant is incorporating. For the purposes of examination, the Examiner will defer to the “or” language and interpret the claims as only requiring of respiration or heart sounds.
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.
(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 1-7, 9-15 and 21, 22 and 24 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Zhang et al. (8,617,082).
Regarding Claims 1, 9 and 21, Zhang discloses a signal receiver circuit 82 (Fig. 3) configured to receive heart sounds and an assessment circuit 80 (Fig. 3, 4) configured to determine a patient metric using the heart sounds (comparisons of previous S3/S4 sounds; and determine an indication of a predicted response (predicted improvement from optimization, such as a predicted minimization of amplitude or duration of S3 and/or S4 sounds) based on the determined patient metric; and provide the optimization to a user or process (col. 18, lines 5-15).
In regards to Claims 2, 10 and 19, Zhang discloses heart sound sensor 82 can be a distinct structure on a lead (separate from the stimulator housing) and/or can be a separate sensor wirelessly connected to the IMD (col. 12, lines 57-64). In this configuration, Zhang discloses the assessment circuit 80 inside the IMD housing receives information form the first medical device (sensor on a lead or remote sensor connected via a wireless connection).
Regarding Claims 3 and 11, Zhang discloses comparing the heart sound metric to a threshold (col. 17, lines 29-35) and further discloses that the predicted response is an indication that a patient will respond to therapy and ultimately minimize the amplitude and/or duration of S3 and/or S4 sounds (col. 18, lines 4-15).
In regard to claims 4-7, 12-15 and 24, Applicant is requiring both heart sound and respiration information. However, the broadest reasonable interpretation of Claims 1, 9 and 17, from which Claims 4-7, 12-15 and 20 depend, only require one of heart sound or respiration. The Examiner has interpreted claims 1, 9 and 17 as only requiring heart sounds and thus does not require respiration signals. For the purposes of interpretation, Claims 4-7, 12-15 and 24 are being interpreted as only requiring heart sounds and Zhang discloses the heart sound information contains S1-S4 information, such as amplitudes and durations (col. 18 lines 1-15).
Regarding Claim 22, Zhang discloses enabling (e.g. applying) the new CRT parameters in response to the determination that an optimization for a predicted optimal response is needed (col. 18, lines 11-13).
Claims 1, 2, 9, 10 and 21-23 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Gillberg et al. (2021/0196132).
Regarding Claims 1, 9 and 21-23, Gillberg discloses a medical device system comprising a signal receiver circuit 86 (Fig. 3) to receive physiological information, one type being heart sounds from an ambulatory motion sensor 38 (par. [0037, 0059]). Gillberg further discloses an assessment circuit 80 configured to determine patient metrics from the heart sounds; and determine a predicted response to CRT therapy using a cardiovascular (CV) model(par. [0041, 0165, 0191]). Lastly, Gillberg discloses providing the results of the simulation/prediction to a user or process and implementing (enabling) the new parameters (par. [0009, 0031]).
In regards to Claims 2, 10 and 19, Gillberg discloses a first medical device (i.e. a motion sensor) that is a distinct device with its own housing from a second implantable medical device, e.g. a housing 60 having stimulation circuitry 84 therein, see Fig. 2 and 3). They are subcomponents of the same system but meet the BRI of a first and second medical device that are distinct from one another.
Claim Rejections - 35 USC § 103
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 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.
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 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Gillberg et al. (2021/0196132) in view of Zhou (PGPUB 2023/0068131). Gillberg discloses utilizing impedance measurements in the therapy modelling but fails to disclose transthoracic impedance. However, Zhou discloses utilizing transthoracic impedance measurements along with other measures such as heart sounds to identify abnormalities and ultimately optimize therapy parameters to be delivered to the patient (par. [0083-0088, 0121-0124, 0127, 0138]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Gillberg reference to include transthoracic impedance sensing, as taught and suggested by Zhou, for the purpose of identifying abnormalities and ultimately optimizing therapy parameters to be delivered to the patient.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (8,617,082) in view of Perschbacher et al. (2019/0231207).
The Examiner notes this rejection is being made in the event Applicant intends therapy optimization to be in response to both RSBI and S1 and S3 sounds. While the claims do not necessarily set forth this combination (see the 35 USC 112b rejection above), this potential alternative is being addressed for the sake of compact prosecution.
Regarding Claim 24, Zhang discloses comparing the heart sound metric to a threshold (col. 17, lines 29-35) and further discloses that the predicted response is an indication that a patient will respond to therapy and ultimately minimize the amplitude and/or duration of S3 and/or S4 sounds (col. 18, lines 4-15). Zhang dos not disclose the use of RSBI information in predicting a possible therapy outcome/response. However, in the same field of endeavor of CRT pacing, Perschbacher discloses an arrhythmia detection algorithm can rely on other metrics such as RSBI in conjunction with hearts sounds, for the purpose of more accurately classifying abnormal heart events (par. [0063, 0083]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Zhang reference to include RSBI analysis, as taught and suggested by Perschbacher, for the purpose of more accurately classifying abnormal heart events.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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