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 .
Priority
Claims 30-50 are deemed to have an effective filing date of April 14, 2017 as the provisional application fails to disclose determining a lower pacing rate and a ventricular pacing percentage and comparing the determined values with respective thresholds to select/choose the exposure mode of therapy.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0007], lines 7-8, of the originally-filed specification (OFS), in pertinent part, reads: “the pacing percentage is not lower than the pacing percentage, then”. The Examiner believes “threshold” is missing from the second recitation of “pacing percentage” as the pacing percentage cannot be lower that itself.
In paragraph [0076] of the OFS, line 3, “query operation 808” should be --query operation 806-- to be consistent with the rest of the specification and the drawings.
Appropriate correction is required.
Claim Objections
Claim 43, 44, and 47 are objected to because of the following informalities: The word “heart” is misspelled in line 3, 2, or 2, respectively.
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 30 and 32-50 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.
The term “lower pacing rate” in claims 30 and 50 is a relative term which renders the claim indefinite. The term “lower pacing rate” is 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. In addition, it is unclear to what the lower “pacing rate” refers. Is it the pacing rate of the therapy energy as in US 2011/0196450 to McClure et al., paragraph [0057]? Or, the rate of the heart beat (e.g., paragraph [0005] of US 2003/0144706 to Funke)?
In addition, the recitation of “the pacing percentage is not lower than the pacing percentage, then choosing” (claim 30, lines 9-10; claim 50, lines 11-12) is indefinite as it appears a word or words are missing. Thus, the scope of claims 30 and 50 is vague and indefinite.
Claims 32-49 are rejected because they depend from an indefinite claim.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2011/0077706 to Ellingson et al. is directed to automatic selection of parameters of an exposure mode of an implantable medical device (IMD). Ellingson discloses that its processor may determine a pacing percentage and when the pacing percentage is less than the threshold pacing percentage, the processor selects a non-pacing mode (e.g., paragraph [0083]). In addition, when the pacing percentage is greater than or equal to the threshold pacing percentage (i.e., not lower than), the processor chooses an operating mode, which could be a permanent pacing mode. Ellingson discloses determining a heart rate and a rate of therapy, but, in as much as the claim is understood, does not appear to choose a non-pacing rate when a lower pacing rate is lower than rate threshold (see paragraphs [0086] and [0113]: when the determined pacing rate is less than the threshold heart rate, the processor may set a pacing mode with a pacing rate of 85 beats per minute) .
US Patent Application Publication No. 2003/0144706 to Funke is directed to a method and apparatus for controlling an IMD in response to the presence of a magnetic field which discloses parasystoly occurs when the IMD attempts to stimulate the heart at a rate lower than the patient’s actual spontaneous heart rate (e.g., paragraph [0005]); but does not appear to describe when the heart rate/energy/stimulation rate is less than the rate threshold.
US Patent Application Publication No. 2011/0196450 to McClure et al. is directed to an electronic prescription activation device and teaches that an IMD may be programmed with the electronic prescription before the patient has a medical procedure such as an MRI scan (e.g., paragraphs [0056]-[0057]).
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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792