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 § 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 5 and 9 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.
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 “larger than 3”, and the claim also recites “larger than 10” 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.
Likewise, Claim 9 includes the broad rage 20-60 followed by he narrower range 40-50.
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, 6 and 10-13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Hess et al. (2003/0120317).
Regarding Claims 1 and 13, Hess discloses an implantable medical device and method of operating the device, wherein the device comprises a processor 68 (i.e. the claimed generator device) that is configured to process cardiac sensed signals and control pacing therapy (par. [0034]). The processor 68 is configured to detect atrial cycle lengths (the claimed atrial interval) in order to detect an atrial tachyarrhythmia, see par. [0040]. Once the tachyarrhythmia is detected, an ATP therapy is triggered from a sequence of ATP therapies (par. [0040]). Upon triggering the first therapy using the cycle length, a record (reference value) is made of the cycle length/tachyarrhythmia classification and/or the time length of the episode. After delivery of the first therapy, the heart rhythm and cycle length is re-assessed. If there is no change (the classification stays the same due to a comparison of the current cycle length value to the one for which therapy was already applied), therapy is withheld. However, if there is a change (the cycle length changes from the originally classified cycle length by an amount that places it in another classification category and/or if the episode time exceeds a limit) a second ATP therapy from the sequence of therapies is selected and applied. (see par. [0049-0055]).
With regard to Claim 6, Hess discloses only applying ATP therapy for the same classification when a predetermined amount of time has elapsed from the application of the first therapy (par. [0050]).
In regard to Claim 10, the iterative process of storing and tracking which arrhythmia classifications have been made and what associated ATP therapies of a sequence have been applied. This can happen for first, second, third, etc. sequences. Each time a classification is made and ATP is delivered, the reference values representing what was selected are updated. (par. [0055]).
Regarding Claims 11 and 12, Hess also discloses detecting a stability measure, namely a regularity of the rhythm, that can also be used to trigger ATP therapy (par. [0055])
Claim Rejections - 35 USC § 103
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 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.
Claims 2, 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. (2003/0120317).
In regards to Claim 2, Hess discloses the changes to interval values that correspond to different bins of classification that are spaced 50-100ms apart in exemplary cases (par. [0059]). While some values of change could be within the 25-100ms range claimed, this does not necessarily mean all changes that create a new classification would be in the claimed range. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to delineate classification bins in a range of 25-100ms, since it has been held that where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. In re Wertheim, 191 USPQ 90.
Regarding Claim 3, while Hess discloses the bins can be separated by time values such as 50 50 ms and whole there are scenarios of changes in interval values that would amount to a 50% change (such as a value of 100ms being classified in bin 1 and a value of 150ms being classified in bin 2, wherein such an increase is a 50% increase) the Examiner notes that the exact range of changes (10-50%)is not explicitly disclosed by Hess. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to rely on percentage changes of 10-50% to delineate the bins, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
In regard to Claim 7, Hess discloses only reapplying the same ASTP therapy if a maximum time limit has been reached but does not set forth any particular value for the time limit. It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to set a max time limit of 1-20 minutes, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. (2003/0120317) in view of Bardy (US Patent 5,292,338).
Regarding Claim 4, Hess discloses all of the claimed invention except for averaging the AA (also called P-P) intervals to identify a tachyarrhythmia. However, the use of average AA intervals to identify a tachyarrhythmia is well-known and well-established in the art, as disclosed by Bardy (col. 6, lines 26-32). This provides the benefit of accurately determining sustained arrhythmias versus a singular episode or errant reading. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Hess reference to include averaging multiple AA intervals, as taught and suggested by Bardy, for the purpose of accurately detecting sustained tachyarrhythmia events.
In regard to Claim 5, Hess and Bardy disclose averaging multiple AA intervals but fails to disclose the exact number of intervals that are averaged. It would have been obvious to one having ordinary skill in the art at the time the invention was made to average at least 3 intervals, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hess et al. (2003/0120317) in view of Brandell (US Patent 6,068,651).
Regarding Claims 8 and 9, Herss discloses all of the claimed features except for preventing therapy when a coagulation time window has elapsed. However, in the same field of endeavor of treating atrial arrhythmias, Brandell discloses locking out stimulation therapy after an extended amount of time (such as 24 hours) in order to prevent blood coagulation by allowing a physician to treat the patient with anticoagulants (col. 8, lines 10-20). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in the Hess reference to include ceasing therapy after 24 hours, as taught and suggested by Brandell, for the purpose of preventing blood coagulation by allowing a physician to treat the patient with anticoagulants.
Conclusion
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
