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 .
Election/Restrictions
Applicant’s election without traverse of Group 1 (Claims 1-7) in the reply filed on 06/08/2026 is acknowledged.
Claims 8-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/08/2026.
Information Disclosure Statement
The Information Disclosure Statement filed 07/30/2024 has been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities:
Page 4, line 23: “Thepeaks” should be changed to “The peaks”.
Page 10, line 31: “is inserted once 521” should be changed to “in inserted at once 521” or “is inserted 521”.
Appropriate correction is required.
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 2-7 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 2-7 recite the limitation “Active electrical system of claim 1” in line 1, whereas an active electrical system was already introduced in a claim that claims 2-7 depend from (claim 1). Consider changing to “The active electrical system of claim 1”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation “in implantable defibrillators”, and the claim also recites “in particular in non-transvenous defibrillators” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The terms “intrinsic non-malignant rhythm” and “intrinsic malignant rhythm” in claim 3 are relative terms which render the claim indefinite. The terms “intrinsic non-malignant rhythm” and “intrinsic malignant rhythm” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It would be unclear and subjective as to what the standard or threshold for the algorithm’s classification of “malignant” and “non-malignant” rhythms. In other words, what would qualify for non-malignant vs. malignant according to the algorithm?
Claim 4 recites the limitation "the cardiac arrest" in line 2. There is insufficient antecedent basis for this limitation in the claim. The Examiner ponders whether Applicant intended for claim 4 to depend from claim 3, which mentions “a total and/or ventricular cardiac arrest”.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites the broad recitation “cardiac events”, and the claim also recites “in particular a trigger timing” which is the narrower statement of the range/limitation. Also, claim 5 recites the broad recitation “morphological features of a signal curve around a cardiac event”, and the claim also recites “in particular an area under the signal curve” which is the narrower statement of the range/limitation. Also, claim 5 recites the broad recitation “signal blocks”, and the claim also recites “in particular metrics of block features” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The terms “malignant and non-malignant rhythms and/or signal features” in claim 6 are relative terms which render the claim indefinite. The terms “malignant and non-malignant rhythms and/or signal features” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It would be unclear and subjective as to what the standard or threshold for the algorithm’s classification of “malignant” and “non-malignant” rhythms. In other words, what would qualify for non-malignant vs. malignant according to the algorithm?
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “comparing with a threshold value in the time domain”, and the claim also recites “in particular counting zero crossings” which is the narrower statement of the range/limitation. Also, claim 7 recites the broad recitation “comparing with a threshold value…in the frequency domain”, and the claim also recites “in particular determining a signal energy in specific frequency bands” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Stephens, et al. (US 5,292,339 – cited on IDS).
Regarding claim 1, Stephens teaches (Fig. 1, # 10 – arrhythmia control system, i.e. active electrical system) active electrical system comprising implantable components and an external programming unit (Col. 3, line 56 – Col. 4, line 8; Col. 4, lines 49-54 – external programmer), the system further comprising:
(Fig. 2, # 12 – electrode lead, i.e. electrode pair, 35 – pacing circuit, 37 – sensing circuit) at least two electrode poles forming at least one electrode pair configured to provide energy delivery and sensing (Col. 4, line 28 – Col. 4, line 48);
(Fig. 2, # 12 – electrode lead, 35 – pacing circuit, i.e. pulse delivery unit) a pulse delivery unit for generating electrical pulses and delivery via the at least one electrode pair (Col. 4, lines 38-48 – Pacing circuit 35 causes pulse generator 36 to generate pacing pulses 44 which are delivered to the patient's heart 14 by means of cardiac lead 12.);
(Fig. 2, # 12 – electrode lead, 37 – sensing circuit, i.e. sensing unit, 39, 41) a sensing unit for sensing electrical cardiac signals via the at least one electrode pair within a predetermined time period (Col. 4, lines 27-37);
(Fig. 4, # 82 and 84 – classification of bradycardia or tachyarrhythmia) an algorithm for classifying the sensed electrical cardiac signals (Col. 5, lines 45-65); and
(Fig. 1, # 16 – microprocessor, 39 – control) a control unit (Col. 4, lines 22-26) configured to (Fig. 4, # 87 – deliver antitachyarrhythmia pacing, i.e. first mode) drive the pulse delivery unit in a first mode to deliver a predetermined number of pulses at repetition rates greater than or equal to a threshold value (Col. 5, line 66 – Col. 6, line 7), and to (Fig. 4, # 91, 94) drive the pulse delivery unit in a second mode to deliver a predetermined maximum number of pulses at repetition rates below the threshold value (Col. 6, lines 8-21 and 38-48 – Examiner notes that Stephens discloses sets a high pacing rate so that pulses will be delivered at repetition rates below that high pacing rate (i.e., threshold value)), and wherein (Fig. 4, # 91[Wingdings font/0xE0]94[Wingdings font/0xE0]87) the control unit in the second mode is configured to switch to the first mode or terminate pulse delivery depending on a classification result of the algorithm (Col. 6, lines 38-48 – if the time since reversion is not equal to or greater than the post therapy time out, the loop passes back to 82 [(i.e., and back to 87 (first mode))]).
Therefore, claim 1 is unpatentable over Stephens, et al.
Regarding claim 2, Stephens teaches active electrical system of claim 1, wherein (Fig. 4) the active electrical system is configured to provide post-shock stimulation in implantable defibrillators, in particular in non-transvenous defibrillators (e.g., Abstract – Upon detection and confirmation of a tachycardia, antitachycardia therapy in the form of antitachycardia pacing pulse therapy and/or cardioversion or defibrillation therapy is delivered to the heart. Thereafter, upon reversion of the tachycardia, bradycardia support pacing is again delivered to the heart but at a greater rate than the earlier normal standby rate and only for a predetermined time period).
Therefore, claim 2 is unpatentable over Stephens, et al.
Regarding claim 3, Stephens teaches active electrical system of claim 1, wherein (Fig. 4, # 82, 84) the algorithm is configured to classify a total and/or ventricular cardiac arrest, an intrinsic non-malignant rhythm, an intrinsic malignant rhythm and/or technical or physiological signal disturbances (Col. 5, lines 45-65; Examiner notes that bradycardia and tachyarrhythmia would be considered intrinsic malignant rhythms).
Therefore, claim 3 is unpatentable over Stephens, et al.
Regarding claim 4, Stephens teaches active electrical system of claim 1, wherein the algorithm is configured to (Fig. 4, # 82, 84, 85) determine an occurrence of the cardiac arrest by comparing a signal range and/or a signal energy with a predetermined threshold value (e.g., Col. 5, lines 45-65).
Therefore, claim 4 is unpatentable over Stephens, et al.
Regarding claim 5, Stephens teaches active electrical system of claim 1, wherein the algorithm is configured to (Fig. 4, # 82, 84, 85) detect and classify an intrinsic heart rhythm by evaluating cardiac events, in particular a trigger timing, morphological features of a signal curve around a cardiac event, in particular an area under the signal curve, a peak-to-peak time interval, a jagged difference, and signal blocks, in particular metrics of block features (e.g., Col. 5, lines 45-65).
Therefore, claim 5 is unpatentable over Stephens, et al.
Regarding claim 6, Stephens teaches active electrical system of claim 1, wherein (Fig. 4) the algorithm is configured to determined and distinguish between malignant and non-malignant heart rhythms and/or signal features (e.g., Col. 5, line 45 - Col. 6, line 7).
Therefore, claim 6 is unpatentable over Stephens, et al.
Regarding claim 7, Stephens teaches active electrical system of claim 1, wherein (Fig. 4) the algorithm is configured to detect signal perturbations by evaluating metrics and/or comparing with a threshold value in the time domain, in particular counting zero crossings, and/or in the frequency domain, in particular determining a signal energy in specific frequency bands (e.g., Col. 5, line 45 - Col. 6, line 7).
Therefore, claim 7 is unpatentable over Stephens, et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL TAYLOR HOLTZCLAW whose telephone number is (571)272-6626. The examiner can normally be reached Monday-Friday (7:30 a.m.-5:00 p.m. EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL T. HOLTZCLAW/Primary Examiner, Art Unit 3796
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