DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 27 and 42-62 are pending.
Claims 1-26 and 28-41 are cancelled.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27, 42, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Eggen et al. (US 20160310723 A1, A1, 2016-10-27) (hereinafter “Eggen”) in view of van der Burg et al. (US 20130110154 A1, 2013-05-02) (hereinafter “van der Burg”).
Regarding claims 27, 42, and 61, Eggen teaches a method for implanting a leadless pacemaker device within a left atrial appendage extending from a left atrium of a heart. See, e.g., [0025]. However, Eggen does not teach the specific method steps recited in the claims.
van der Burg teaches a method for implanting a device within a left atrial appendage extending from a left atrium of a heart, comprising: introducing a distal end of a delivery sheath into the left atrium; deploying a plurality of elements of the device sequentially from the distal end into the left atrium, the elements adopting an expanded configuration within the left atrium; advancing the elements from the left atrium into the left atrial appendage; and releasing the elements to implant the device within the left atrial appendage. See, e.g., [0012], [0019], [0105], [0121], [0017] (“In another embodiment, the left atrium is accessed by surgical heart procedure. The implant can be distally advanced along the left atrium access path, and the implant can be manually delivered to the left atrial appendage of the patient.”). See also Figs. 30-31 and associated text.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of van der Burg with the invention taught by Eggen such that the invention further comprises introducing a distal end of a delivery sheath into the left atrium; deploying a plurality of elements of the pacemaker device sequentially from the distal end into the left atrium, the elements adopting an expanded configuration within the left atrium; advancing the elements from the left atrium into the left atrial appendage; and releasing the elements to implant the device within the left atrial appendage (as recited in claim 27); wherein the elements are connected sequentially together by connectors between adjacent elements, the connectors allowing the elements to translate relative to adjacent elements when the elements are deployed from the distal end of the delivery sheath to adopt the expanded configuration (as recited in claim 42); wherein the elements comprise a plurality of battery subunits electrically coupled together by one or more connectors between the subunits (as recited in claim 61) in order to improve the effectiveness of the procedure.
Allowable Subject Matter
Claims 50-60 are allowed.
Claim 43-49 and 62 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The prior art of record does not teach or suggest the claimed invention of a a method for implanting a leadless pacemaker device within a left atrial appendage extending from a left atrium of a heart, wherein the elements are connected sequentially together by connectors between adjacent elements, the connectors biased to a nonlinear shape such that, when the elements are deployed from the distal end of the delivery sheath, the connectors automatically cause the elements to fold into the expanded configuration (as recited in claim 43); further comprising: deploying a cover operatively coupled to the elements; and isolating the left atrial appendage from the left atrium using the cover after advancing the elements into the left atrial appendage (as recited in claim 46); further comprising delivering energy from the pacemaker device to ablate atrial tissue to electrically isolate the left atrial appendage from the rest of the left atrium (as recited in claim 49); a method for monitoring and reducing atrial fibrillation episodes, comprising: electrically isolating a left atrial appendage (LAA) extending from a left atrium of a heart. after isolation is confirmed, placing a leadless pacemaker within the LAA such that the leadless pacemaker has contact with atrial tissue outside of the LAA; and delivering overdrive pacing via the leadless pacemaker to help prevent and terminate AF episodes (as recited in claim 50); and a method for implanting a leadless pacemaker device within a left atrial appendage extending from a left atrium of a heart, comprising: introducing a distal end of a delivery sheath into the left atrium; deploying a plurality of elements of the pacemaker device sequentially from the distal end into the left atrium; advancing the elements from the left atrium into the left atrial appendage; releasing the elements to implant the device within the left atrial appendage; and deploying a cover after advancing the elements into the left atrial appendage to isolate the left atrial appendage from the left atrium (as recited in claim 52); wherein the elements comprise a power source and one or more electrodes coupled to the power source. the method further comprising delivering energy from the one or more electrodes to ablate atrial tissue to electrically isolate the left atrial appendage from the rest of the left atrium (as recited in claim 62).
For these reasons the claims are believed to be allowable over the art of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Jackson, can be reached on 571-272-4697. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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