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.
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:
“A module for calculating a cardiac rhythm, HR, setpoint value, intended to control a rate of pacing pulses issued by an active implantable medical device based on a patient's activity” in claim 1
“A module for calculating a cardiac interval, RR, setpoint value, intended to control a rate of pacing pulses issued by an active implantable medical device based on a patient's activity” in claim 12
Best support seems to be pg. 5 lines 1-5 of applicant’s specification received on 5/6/2025…. “the module comprises a microcontroller operating without being put to sleep between two consecutive cardiac cycles” of applicant’s specification received on which describes the module as being a microcontroller. Therefore, the module in claims 1 and 12 is understood to be a microcontroller and/or its functional equivalent.
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
Claims 1 and 12 are objected to because of the following informalities:
Claim 1 should be amended as follows:
“A module for calculating a cardiac rhythm and a heart rate (HR) setpoint value intended to control a rate of pacing pulses issued by an active implantable medical device based on a patient's activity,”
Claim 12 should be amended as follows:
“A module for calculating a cardiac interval and a RR setpoint value intended to control a rate of pacing pulses issued by an active implantable medical device based on a patient's activity,”
Appropriate correction is required. Claims 2-11 and 13-22 are objected based on dependency to either claim 1 or 12 above. Also, please double check grammar of all the claims.
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.
Claims 2, 11, 13 and 22 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.
Regarding claims 2 and 13, both claims recite the limitation:
“wherein the module is integrated to an ASIC circuit”
Both claims recite the claimed module is integrated with ASIC circuit, but never positively claim the circuit as being part of the module (and therefore part of the invention), only that that module is integrated with an ASIC circuit. This raises questions as to what the metes and boundaries are to this claim. Specifically, the question of whether the circuit is required or not is raised. For this examination it has been interpreted that the circuit is required. Regardless, if this is applicant’s intended interpretation or not, this limitation needs to be clarified.
Regarding claims 11 and 22, both claims recite the limitation:
“wherein the module is integrated to an active medical device of the implantable autonomous capsule type which houses, in a device body, an electronic unit including”
Both claims recite the claimed module is integrated with the medical device and its further listed parts, but the claim never positively claims the implantable device only a module and that the module is integrated with an integrated medical device and its further specific structures. This raises questions as to what the metes and boundaries are to this claim. Specifically, is the medical device and its further listed parts being claimed or not. For this examination it has been interrupted that the medical device and its further specific structures are claimed. Regardless, if this is applicant’s intended interpretation or not, this limitation needs to be clarified.
Allowable Subject Matter
Claims 1, 3-10, 12 and 14-21 would be allowable if rewritten to overcome the objection(s), set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 2, 11, 13 and 22 would be allowable if rewritten to overcome the objection(s) and rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 1 and 12 are the broadest independent claims. The closest prior art is Sheldon et al (US 20200147396) hereafter known as Sheldon.
Regarding claim 1,
Sheldon discloses:
A module for calculating a cardiac rhythm, HR, setpoint value, intended to control a rate of pacing pulses issued by an active implantable medical device based on a patient's activity [see para 67… “The functions attributed to pacemaker 14 herein may be embodied as one or more processors, controllers, hardware, firmware, software, or any combination thereof.”],
wherein the HR setpoint value is continuously determined by digital processing of a sampled activity signal representative of a patient's instantaneous activity [see para 59… “In order to avoid abrupt changes in pacing rate, the target heart rate may be determined from the patient activity metric, and the SIR may be determined from the target rate according to the transfer function that controls how quickly the SIR accelerates or decelerates up to or down to the target rate as patient activity increases or decreases, respectively.”],
wherein the module further comprises:
- a conversion stage, receiving as an input a current value of the sampled activity signal and outputting a first target HR value, obtained by application of a predetermined activity vs. cardiac rhythm function to a current value of the sampled activity signal [see para 59… “In order to avoid abrupt changes in pacing rate, the target heart rate may be determined from the patient activity metric, and the SIR may be determined from the target rate according to the transfer function that controls how quickly the SIR accelerates or decelerates up to or down to the target rate as patient activity increases or decreases, respectively.”];
However, Sheldon fails to fully disclose “a first low-pass digital filtering stage, comprising a recursive filter capable of calculating, over a first predetermined duration, a first moving average of the first target HR value issued by the conversion stage, outputting a second target HR value” and “ a combiner stage, receiving as an input (i) the first target HR value issued by the conversion stage, and (ii) the second target HR value issued by the first low-pass digital filtering stage, and adapted to determine a maximum of the first and second target HR values received as an input, thereby outputting the HR setpoint value to control the rate of pacing pulses based on the patient's activity”. Furthermore, nothing in the prior art when viewed Sheldon obviates these deficiencies. It is important to note that the missing limitations do not by themselves define the invention over the prior art. Rather, it is the missing limitations in combination with all the limitations of claim 1, together which defines the invention over the prior art. Therefore, the combination of claimed limitations of claim 1 is neither anticipated nor obviated in view of the prior art.
Regarding claim 12,
Sheldon discloses:
A module for calculating a cardiac interval, RR, setpoint value, intended to control a rate of pacing pulses issued by an active implantable medical device based on a patient's activity [see para 67… “The functions attributed to pacemaker 14 herein may be embodied as one or more processors, controllers, hardware, firmware, software, or any combination thereof.”], wherein the RR setpoint value is continuously determined by digital processing of a sampled activity signal representative of the patient's instantaneous activity [see para 47… “Cardiac event detector 224 may include a sense amplifier, comparator or other detection circuitry that compares the incoming rectified, cardiac electrical signal to an R-wave detection threshold amplitude, which may be an auto-adjusting threshold.”]
wherein the module further comprises:
“a conversion stage, receiving as an input a current value of the sampled activity signal and outputting a first target RR value, obtained by application of a predetermined activity vs. cardiac interval function to a current value of the sampled activity signal” [see
para 47… “Cardiac event detector 224 may include a sense amplifier, comparator or other detection circuitry that compares the incoming rectified, cardiac electrical signal to an R-wave detection threshold amplitude, which may be an auto-adjusting threshold.”]
However, Sheldon fails to fully disclose “a first low-pass digital filtering stage, comprising a recursive filter capable of calculating, over a first predetermined duration, a first moving average of the first target RR value issued by the conversion stage, outputting a second target RR value” and “a combiner stage, receiving as an input (i) the first target RR value issued by the conversion stage, and (ii) the second target RR value issued by the first low-pass digital filtering stage, and adapted to determine a minimum of the first and second target RR values received as an input, thereby outputting the RR setpoint value, to control the rate of pacing pulses based on the patient's activity.”
Furthermore, nothing in the prior art when viewed Sheldon obviates these deficiencies. It is important to note that the missing limitations do not by themselves define the invention over the prior art. Rather, it is the missing limitations in combination with all the limitations of claim 12, together that defines the invention over the prior art. Therefore, the combination of claimed limitations of claim 12 is neither anticipated nor obviated in view of the prior art.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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