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 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.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims recite a memory and processor which are in communication. This could be transitory or a non-transitory memory component. The use of transitory memory is not within the statutory subject matter. It is suggested that the language is amended to recited “non-transitory memory”.
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 1-7 and 9-16 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 3-4 recite “monitoring a total number of historical detection intervals belonging to atrial tachycardia intervals within a set time of a target pacemaker in a tracking mode”. It is first unclear what applicant intends “a total number of historical detection intervals” to be. A detection interval could be a segment of time in which cardiac signals are monitored, such as the P-wave, R-wave, T-wave, PP interval (atrial depolarization) or RR intervals (ventricular depolarizations), to name a few. An atrial detection interval would be the PP interval, often referred to as the PPI. This is known in the art to be the time from the detection of a first P wave to a second P wave in a cardiac ECG, often used to determine atrial tachycardia. This claim language indicates that all of the signals monitored fall into a category of tachycardia. It is unclear how all detection intervals, which are previously recorded or sensed (indicating historical) can all belong to atrial detection intervals, this would indicate that the entire ECG segment is comprised only of atrial tachycardia. Although this language is unclear and indefinite proposed claim language could include “monitoring historical intervals to determine atrial tachycardia intervals using a target pacemaker in a tracking mode.”
Claim 1, lines 5-6 recite; “in the case that the total number is within a first preset number range threshold, adjusting an atrial-ventricular delay interval duration of the target pacemaker”. Initially, the language “in the case” lacks proper antecedent basis and should read “in a case”. It is unclear what a preset number range threshold is or could be. This could be a number range as in 3-5 or it could be a threshold which is either an upper or lower threshold. For instance if a threshold is 5 then if more than 5 events are detected it exceeds the threshold. If it is a range then if 4 events are recorded it falls within the 3-5 range. It is suggested that this language is amended to recite a threshold or a range however the use of both is indefinite. Finally, with respect to this language it is unclear and indefinite what applicant intends an atrial-ventricular delay interval duration to be. In the field of pacing cardiac tissue that atrial-ventricular delay is the time in which the cardiac signal from the atria travels to the ventricle. Stated another way, the AV delay is the time in between the contraction of the upper atrial chambers and the contraction of the lower ventricular chambers. In this case the pacemaker appears to be adjusting the AV delay, which is a stimulation signal, based on the number of tachycardia events detected within a detection window. The language atrial-ventricular delay interval duration however is confusing in this context, the AV delay interval can be adjusted, this would happen when a stimulus signal is used to stimulate the AV node thus controlling the AV interval. However, it is not clear what applicant intends an delay interval duration to be, this could be the duration of the signal delivered to control the AV node or it could be something else entirely.
Claim 1, lines 7-10 recite; “determining whether the total number of historical detection intervals belonging to the atrial tachycardia intervals within the set time after the atrial-ventricular delay interval duration of the target pacemaker is adjusted is greater than an upper limit value of the first preset number range threshold”. This language, in light of the language in lines 3-4, is indefinite. It is understood that it would be necessary to determine a total number of intervals belonging to an ATI class however, it is unclear why this determinization is happening after the intervals have already been classified as tachycardia. It is assumed that this language is meant to mean that after the AV delay is adjusted, the device monitors the detection intervals again to determine a count. However the use of the language “greater than an upper limit value of the preset number range threshold”, is indefinite because it is not clear if this is a threshold or a range.
Claim 1, lines 11-14 recite; “in the case that the total number of the historical detection intervals belonging to the atrial tachycardia intervals within the set time after the atrial-ventricular delay interval duration of the target pacemaker is adjusted is greater than the upper limit value of the first preset number range threshold, determining that an atrial tachycardia event occurs.” Initially the language “in the case” lacks proper antecedent basis and should read “in a case”. The language “the atrial-ventricular delay interval” is indefinite as discussed above. The language “the upper limit value of the first preset number range threshold” is also indefinite as discussed above.
Claim 2 recites “further comprising wherein, before the step of determining whether the total number of historical detection intervals belonging to the atrial tachycardia intervals within the set time after the atrial-ventricular delay interval duration of the target pacemaker is adjusted is greater than an upper limit value of the first preset number range threshold”. As above with claim 1 the language is indefinite.
Claim 2 recites “the atrial tachycardia interval” in line 12. This language is indefinite. In this claim there is a new period of monitoring yet “the atrial tachycardia interval” has antecedent basis back to claim 1 which would indicate that it is somehow the same interval. It is suggested that this language is amended to recite “an atrial tachycardia interval.”
Claim 2 recites “in the case that the current detection interval is the atrial tachycardia interval and the current detection interval is within the confirmation period of atrial tachycardia, determining whether the total number of historical detection intervals belonging to the atrial tachycardia within the set time after the atrial-ventricular delay interval duration of the target pacemaker is adjusted is greater than an upper limit value of the first preset number range threshold.” The language “in the case” lacks proper antecedent basis and should read “in a case”. The language “the atrial tachycardia interval” is indefinite in that it is unclear how the same interval is within this language, it is suggested that the language is amended to read “an atrial tachycardia interval”. As with the claim 1 rejection it is indefinite as to what an upper limit value of the first preset number range threshold is or could be.
Claim 3 recites “in the case”, this language lacks proper antecedent basis and should read “in a case”.
Claim 3 recites “acquiring an atrial sensing event in the current historical detection interval” and “determining whether a rate of the atrial sensing event exceeds a atrial tachycardia detection rate”. If a single atrial sensing event is acquired then no rate can be established, therefore this language is indefinite. Regarding the “atrial tachycardia detection rate”, this language is indefinite. The rate could be how often atrial tachycardia is occurring in a signal or it could be the associated with the PPI. For instance the PPI could indicate an atrial heart rate of x beats-per-minute. This language is therefore indefinite. It is further unclear what “the current historical detection interval” is or could be. The language “current” is the opposite of “historical”. Finally the language “a atrial tachycardia” should read “an atrial tachycardia.
Claim 4 recites “in the case” in lines 3 and 7. This language lacks antecedent basis. Further it is unclear how the cases can be separate if the same language is used. It is suggested that the language “in a case” or “in the case” is amended to read “when”, such as “when the rate of the atrial sensing…” for clarity.
Claim 6 recites “determining whether a number of atrial tachycardia intervals identified as integer in the total number is greater than a second preset number threshold”. This language should read “a an integer”. Claim 6 also recites “in the case” in lines 7 and 9. The language lacks proper antecedent basis and is indefinite, it is unclear how the cases are different.
The remainder of the claims are also rejected in that they depend from previously rejected claims. Note that all claims depend from claim 1.
All claims are rejected under 35 U.S.C § 112 and it is improper to rely on speculative assumptions regarding the meaning of a claim and then base a rejection under 35 U.S.C. 103 on these assumptions. (In re Steele 305 F.2d 859,134 USPQ 292 (CCPA 1962)).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Thompson et al. US 2003/0074026 discloses an algorithm for discriminating tachycardias. In this algorithm the AA and VV cycles are monitored, it is determined if the AA intervals (AAI) are within a tachycardia range to determine SVT.
Hess et al. US 5,814,083 discloses a pacemaker to determine tachycardia.
Dong et al. US 2011/0130666 discloses a pacemaker which senses contractions in the atria to control the AV delay time of stimulation (paragraph 0043). The system also determines SVT , ST, AF and AFI (paragraph 0049).
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
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