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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 15th, 2024 is being considered by the examiner.
Priority
The current application claims benefit of provisional application 63335320, filed on April 27th, 2022. Examiner acknowledges the applicant’s claim for priority.
Claim Objections
Claim 1 is objected to because of the following informalities: “wherein the processing unit is further configured produce” should read “wherein the processing unit is further configured to produce”. Appropriate correction is required.
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 limitations are:
“processing unit” in claims 1, 3, 5, 7, and 9. Examiner will interpret this to be a processor, as depicted in page 4, line 7 of the specification.
“detector” in claims 1 and 5. The detector will be interpreted to encompass the structure disclosed in page 6, lines 21-28 or any equivalents thereof.
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they 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 these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-10 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.
Claims 1 and 5 recite the limitation "the subsequent intrinsic ventricular activity signal" in line 10. There is insufficient antecedent basis for this limitation in the claim and should be appropriately amended to “a subsequent intrinsic ventricular activity signal”.
Claims 1 and 5 recite the limitation “the most recently determined intrinsic AV delay” in line 11. There is insufficient antecedent basis for this limitation in the claim and should be appropriately amended to amended to “a most recently determined intrinsic AV delay”.
Claims 2-4 and 6-10 are rejected due to their dependence on indefinite claims 1 or 5.
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 9 and 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claims 1-9 recite subject matter within a statutory category as a process or machine. Claim 9 and claim 10 recite a “computer program product” and “computer readable data carrier”, respectively. Under broadest reasonable interpretation, these encompass transitory signal as “software per se”. Appropriate correction to non-transitory computer readable medium” or other non-transitory equivalents is required. Claims 1-10 recite an application of a mental process by outputting a ventricular pacing signal to a patient. Therefore, claims 1-9 recite eligible subject matter under 35 U.S.C. 101.
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.
Claims 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Carney et al (US20200398064) in view of Bloomqvist et al. (US20110202102).
Regarding claim 1, Carney teaches
A cardiac pacemaker ([0003] “An implantable pacemaker”) comprising a processing unit ([Fig. 4] processing circuitry (70)), a data memory ([Fig. 4] memory (72)), a detector and a pacing signal generator ([Fig. 4] sensing circuitry (78) detects cardiac events), wherein the processing unit, the data memory, the detector and the pacing signal generator are electrically interconnected ([Fig. 4] processing circuitry (70), memory (72), and sensing circuitry (78) are interconnected), wherein the data memory is configured to store a pre-defined programmed AV delay ([0081] “Intervals defined by the timing and control module within processing circuitry 70 may include atrial and ventricular pacing escape intervals”), wherein the detector is configured to detect an intrinsic atrial activity signal and to detect an intrinsic ventricular activity signal ([0081] “sensing circuitry 78 may also sample the detected intrinsic signals to generate an electrogram or other time-based indication of cardiac events” occurs in ventricle and atrial chambers), wherein the processing unit is configured to produce a ventricular pace control signal and to transmit it to the pacing signal generator ([0081] “processing circuitry 70 may determine the time for therapy delivery by another device, such as a pacing signal by PD”), wherein the processing unit is further configured to determine an atrial sense event from the intrinsic atrial activity signal received from the detector ([0038] “ICD 9 may be configured to detect a cardiac event of patient 14, such as an atrial contraction (p-wave)”) and an intrinsic AV delay from the atrial sense event and the subsequent intrinsic ventricular activity signal received from the detector ([0082] “The value of the count present in the interval counters when reset by sensed R-waves and P-waves may be used by processing circuitry 70 to measure the durations of R-R intervals, P-P intervals, P-R intervals and R-P intervals”)
Regarding claim 1, Carney does not explicitly teach, as taught by Bloomqvist, and to determine continuously an average intrinsic AV delay from the most recently determined intrinsic AV delay and previously determined AV delays ([0048] “the assigner 150 preferably determines the expected intrinsic AV delay as an average based on the AV delay from the delay measurer 130”) and to store the average intrinsic AV delay in the data memory, ([0060] “the value associated with the relevant sub-space from the decision support information as stored in the memory”) wherein the processing unit is further configured produce the ventricular pace control signal after one atrial sense event is determined based on the average intrinsic AV delay if the average intrinsic AV delay is fresh or based on the programmed AV delay or on a differently determined AV delay if the average intrinsic AV delay is stale. ([0048] “the weights used in the averaging are preferably larger for more recent AV delays and smaller for older AV delays. The expected AV delay is therefore in this embodiment a time-weighted average of multiple AV delays”)
Bloomqvist comes from the same field of invention as Carney and treats patients with cardiac arrythmias by tracking the AV delay across the cardiac conduction system. Bloomqvist explains “a need for a technique in identifying suitable periods during which "listening" for intrinsic contraction is appropriate and discriminating such periods for occasions where heart pacing instead should be performed” [0007] for the purpose of increasing accuracy of cardiac signals stability across beats. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the AV synchronous cardiac pacemaker in Carney’s reference to continuously update a running average of the measured intrinsic AV delays, as taught and suggested by Bloomqvist, with a reasonable expectation of success, for the purpose of increasing accuracy of cardiac signal stability across beats.
Regarding claim 5, Carney teaches an operation method of a cardiac pacemaker, wherein the pacemaker comprises a processing unit ([Fig. 4] processing circuitry (70)), a data memory ([Fig. 4] memory (72)), a detector and a pacing signal generator ([Fig. 4] sensing circuitry (78) detects cardiac events), wherein the processing unit, the data memory, the detector and the pacing signal generator are electrically interconnected ([Fig. 4] processing circuitry (70), memory (72), and sensing circuitry (78) are interconnected), wherein the data memory stores a pre-defined programmed AV delay ([0081] “Intervals defined by the timing and control module within processing circuitry 70 may include atrial and ventricular pacing escape intervals”), wherein the detector detects an intrinsic atrial activity signal and an intrinsic ventricular activity signal ([0081] “sensing circuitry 78 may also sample the detected intrinsic signals to generate an electrogram or other time-based indication of cardiac events” occurs in ventricle and atrial chambers), wherein the processing unit produces a ventricular pace control signal and transmits it to the pacing signal generator ([0081] “processing circuitry 70 may determine the time for therapy delivery by another device, such as a pacing signal by PD”), wherein the processing unit determines an atrial sense event from the intrinsic atrial activity signal received from the detector ([0038] “ICD 9 may be configured to detect a cardiac event of patient 14, such as an atrial contraction (p-wave)”) and an intrinsic AV delay from the atrial sense event and the subsequent intrinsic ventricular activity signal received from the detector ([0082] “The value of the count present in the interval counters when reset by sensed R-waves and P-waves may be used by processing circuitry 70 to measure the durations of R-R intervals, P-P intervals, P-R intervals and R-P intervals”) and determines continuously an average intrinsic AV delay from the most recently determined intrinsic AV delay and previously determined AV delays ([0048] “the assigner 150 preferably determines the expected intrinsic AV delay as an average based on the AV delay from the delay measurer 130”) and stores the average intrinsic AV delay in the data memory, ([0060] “the value associated with the relevant sub-space from the decision support information as stored in the memory”)wherein the processing unit produces the ventricular pace control signal after one atrial sense event is determined based on the average intrinsic AV delay if the average intrinsic AV delay is fresh or based on the programmed AV delay or on a differently determined AV delay if the average intrinsic AV delay is stale. ([0048] “the weights used in the averaging are preferably larger for more recent AV delays and smaller for older AV delays. The expected AV delay is therefore in this embodiment a time-weighted average of multiple AV delays.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the AV synchronous cardiac pacemaker in Carney’s reference to continuously update a running average of the measured intrinsic AV delays, as taught and suggested by Bloomqvist, with a reasonable expectation of success, for the purpose of increasing accuracy of cardiac signal stability across beats.
Regarding claim 2, Carney teaches all of the limitations of claim 1. Regarding claim 6, Carney Bloomqvist teaches all of the limitations of claim 5. Carney also teaches wherein the average intrinsic AV delay is determined from the most recently determined intrinsic AV delay and previously determined AV delays using a digital averaging. ([0185] “multiple control signals received over time by monitoring running averages, weighted averages, or any other metric for adjusting the communication schedule to align with the transmission schedule of the master device.”)
Regarding claim 3, Carney teaches all of the limitations of claim 1. Regarding claim 6, Carney teaches all of the limitations of claims 5. Regarding claim 3 and 6, Carney does not explicitly teach, as taught by Bloomqvist wherein the processing unit is configured to determine a freshness counter value ([0048] “assigner 150 assigns an expected intrinsic AV delay”) which is increased by a first pre-determined value after one intrinsic AV delay is determined ([0048] “expected AV delay is furthermore determined by the assigner 150 based on the intrinsic AV delay determined by the delay assigner 150”) and is decreased by a second pre-determined value after one ventricular pace control signal is transmitted to the pacing signal generator ([0050] “The delay assigner 150 may furthermore remove identified AV delays associated with a currently identified sub-space if their time stamps have elapsed”), wherein the average intrinsic AV delay is considered fresh if the freshness counter value is equal to or above a freshness threshold and is considered stale if the freshness counter value is below the freshness threshold. ([0048] “AV delay previously assigned to the sub-space is preferably time-stamped in order to allow estimation of how recent the actual delay value is … weights used in the averaging are preferably larger for more recent AV delays and smaller for older AV delays”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the AV synchronous cardiac pacemaker in Carney’s reference to continuously update a running average of the measured intrinsic AV delays, as taught and suggested by Bloomqvist, with a reasonable expectation of success, for the purpose of increasing accuracy of cardiac signal stability across beats.
Regarding claim 4, Carney teaches all of the limitations of claim 1. Regarding claim 8, Carney teaches all of the limitations of claims 5. Carney does not explicitly teach, as taught by Bloomqvist wherein in case the average intrinsic delay is stale, the ventricular pace control signal is produced after one atrial sense event is determined based on a pre-defined hysteresis value ([0061] “A probability estimator 180 uses the provided expected intrinsic AV delay reflective of the current patient condition to estimate an a priori probability that a detected intrinsic or induced atrial electric activity of the heart will trigger intrinsic ventricular electric activity, i.e. depolarization, leading to ventricular contraction within a target AV dela “) and the programmed AV delay or the differently determined AV delay, wherein the programmed AV delay is extended by the hysteresis value or the differently determined AV delay is extended by the hysteresis value. ([0066] “the target delay value is not fixed but is instead adjusted based on where in the parameter space the patient's current condition corresponds to”)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have modified the AV synchronous cardiac pacemaker in Carney’s to have modified the AV synchronous cardiac pacemaker in Carney’s reference to continuously update a running average of the measured and/or expected intrinsic AV delays, as taught and suggested by Bloomqvist, with a reasonable expectation of success, for the purpose of increasing accuracy of cardiac signal stability across beats.
Regarding claim 9, Carney also teaches a computer program product comprising instructions which, when executed by a processing unit, cause the processing unit to perform the steps of the method according to claim 5. ([para 182-183] “Instructions embedded or encoded in an article of manufacture including a non-transitory computer-readable storage medium encoded, may cause one or more programmable processors, or other processors, to implement one or more of the techniques described herein”)
Regarding claim 10, Carney teaches a computer readable data carrier storing a computer program product according to claim 9. ([para 182-183] “The techniques described in this disclosure may also be embodied or encoded in an article of manufacture including a non-transitory computer-readable storage medium encoded with instructions.”)
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Poore et al. (Pat. 5237992) discloses a pacemaker providing hysteresis in dual chamber modes.
Ding et al. (US20020049478) discloses a system for calculating atrio-ventricular delays for optimal timing of a ventricular pacing pulse
Conclusion
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/R.A.S/Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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