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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 17 utilizes the terms “means for receiving…”and “means for determining…”. The “means for receiving” will be interpreted as a signal receiving circuit, see par. [0024] of the PGPUB of the present application). The “means for determining” will be interpreted as an assessment circuit (e.g. a processor), see par. [0024] of the PPGUB of the present application).
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 abstract idea without significantly more.
Step 1
The claims are drawn to products (Claims 1-8 and 17-20) and processes (Claism 9-16)
Step 2A, Prong 1
Claims 1, 9, 17 and 18 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, 17 and 18 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, 17 and 18 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, 10, 19 and 20 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 and 15 only further define the data gathering steps.
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 17-20 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, 17 and 18, 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 f 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 20, 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 20 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).
Claims 1, 2, 9, 10 and 17-19 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, 17 and 18, Gillberg discloses a medical device system comprising a signal receiver circuit 86 (Fig. 3) to receive physiological information, one type being heart sounds form 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 (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.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796