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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/16/2026 has been entered.
Upon further consideration of the claim language and the supporting disclosure, lack of support and lack of clarity issues has resulted in the 112(a) and 112(b) rejections set forth below.
Claim Rejections - 35 USC § 112
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 1-16 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.
Claims 1 and 14 refer to generating an index of “cardiac synchrony”. However, upon further consideration of the specification, the supporting subject matter refers to “tracking of the quality of the heart function and in particular its degree of dyssynchrony” [0009, 0028, 0073].
The specification discloses “a digital model of the heart (e.g., the dyssynchrony model described above) is then customized or personalized based on the extracted parameter set and an dyssynchrony score may be calculated. This score may then be sent back to the cardiologist in real time via a dedicated user interface (e.g., the user interface 140 of FIG. 1)” [0073]. The specification additionally discloses “the state or quality of the heart function is estimated (EST1), such as for example, the rate of dyssynchrony measured at a time T0 during an imaging process. In the next step S405, an implanted or attached therapy device (e.g., the therapy device 150 of FIG. 1) is controlled (CTRL1) by a physician or automatically by a controller (e.g., the heart function estimation controller 130 of FIG. 1). In subsequent step S406, electromechanical parameters are estimated (EST2) in real time via an implanted or attached measuring device (e.g., the measuring device 120 of FIG. 1) at a current time T1” [0086]. Even claim 11 refers to estimating the heart function based on quantification of cardiac dyssynchrony.
As is well known in the art, “cardiac synchrony” is defined as normal, coordinated electrical activation and mechanical contraction of the heart leading to normal blood pumping whereas “cardiac dyssynchrony” is defined as the uncoordinated contraction/electrical activation of the heart chambers leading to inefficient pumping. Therefore, the claim language is not clear relative to the disclosure in the specification with respect to the measure of “cardiac synchrony” or “cardiac dyssynchrony”. It is suggested claim language be modified to clarify the exact parameter this is being evaluated in view of the specification such that the claimed terms have support from the specification.
With respect to claims 1 and 14, the claim language is also directed to generating a “quantitative index” of cardiac synchrony. Upon reviewing the specification, there is no mention of the term “quantitative index”. The specification refers to the “dyssynchrony model” and a “dyssynchrony score” calculation [0073]. If the claims are referring to the “dyssynchrony score”, then it is suggested claim language reflect the terms accordingly to ensure that all claimed terms have support from the disclosure. Under broadest reasonable interpretation, “quantitative index of cardiac synchrony” cannot be interpreted to be the same as “dyssynchrony score” (from the specification).
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 1-16 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.
Claim 1 (lines 11-12) and claim 14 (lines 12-13) refer to executing an algorithm that combines “the information” and “real-time information or physiological data”. From the claim language, it is not clear what the initial reference to “the information” is referring to with respect to the previous steps of the claim (lines 5-7 in claim 1). Based on the specification, the initial reference to the “information” is referring to the “non-real-time electrical, mechanical, and/or hemodynamic signals” [0057]. It is suggested claims 1 and 14 be modified to clarify that it’s the combination of the “non-real-time information” and the “real-time information”.
Claims 1 and 14 refer to “output a quantified cardiac-function indicator derived from the index of cardiac synchrony” (lines 15-16, claim 1). It is not clear from the claim language how this cardiac-or heart-function indicator is derived from the index. As per the specification, paragraphs [0062-0065] refer to estimation of the heart function based on supervised learning or unsupervised learning or other AI-based algorithms or based on quantification of cardiac dyssynchrony based on AI approaches. It is suggested claims 1 and 14 provide clarifying language with respect to how the quantification is executed as the main objective is to determine this cardiac-function indicator to control or optimize operation of the therapy device.
The dependent claims stand rejected under 112(b) as they don’t provide additional clarity.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an information gathering system for retrieving the information”, “diagnostic system configured to measure…signals from the heart”, “therapy system configured to deliver therapy” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 6 is objected to because of the following informalities: There appears to be a closing period missing at the end of the claim after “heart function”. Appropriate correction is required.
Additional Relevant Prior Art:
Shute et al. (2021/0030295):
Directed to estimating activity, detect characteristics of heart sound component such as S1-S4 heart sounds, generate a cardiac function indicator indicating myocardial contractibility, cardiac synchrony, and cardiac hemodynamics, or other diagnostics, detect cardiac arrythmia or detect heart failure [0086]. But does not teach of the claim processing with “real-time physiological data representative of the electrical, mechanical, and/or hemodynamic heart function from a measuring device attached or implanted to the patient; executing, by the processor, an electromechanical heart-modeling algorithm that combines the information and the real-time physiological data by correlating time-aligned electrical-signal features, mechanical-motion features, and hemodynamic-pressure features to generate a quantitative index of cardiac synchrony; and outputting, by the processor, a quantified cardiac-function indicator derived from the index of cardiac synchrony to control or optimize operation of a cardiac- therapy device”.
Ludwig et al. (2013/0072790):
“Analysis component 104 can be employed, for example, to determine or develop a condition of a patient's heart, whether the patient is a good candidate for cardiac resynchronization therapy, an optimized approach to applying cardiac resynchronization therapy, a guide for a surgeon to perform a procedure related to cardiac resynchronization therapy, and other aspects. Observed and/or computed factors apposite to such determinations and/or developments can include, but are not limited to, the impact of scar tissue in the heart on the heart's function, electrical conduction and other electrical properties, cardiac asynchrony, properties that continuously or periodically impact the heart's electrical function and interaction, or properties that continuously or periodically impact cardiac synchrony” [0041].
Conclusion
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797