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
Claims 2-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 20, 2025.
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, 6-8 & 17-20 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. Please see the below reasons:
In regards to claim 1, the claim limitation “…in the second configuration, the optical component is positioned at least partially adjacent to the electrical stimulation implant…” is unclear because the claim does not set forth the degree or boundaries of what constitutes “at least partially adjacent.” It is therefore unclear how close the optical component must be to satisfy this limitation.
In regards to claim 1, the claim limitation “…capture image data of a region at and/or near the distal opening,” renders the scope of the claim unclear because the spatial extent of “near” is not defined and the use of “and/or” introduces ambiguity as to whether the region must be at the distal opening, near the distal opening or both.
In regards to claim 1, the claim limitation “the distal portion of the elongated sheath is configured to expand in cross-sectional dimension when the optical component moves from the first configuration to the second configuration,” is unclear because the claim does not specify the structure or mechanism by which the expansion occurs, nor does it clarify whether the movement of the optical component necessarily causes expansion or merely occurs contemporaneously, i.e. the scope of the limitation is uncertain.
In regards to claim 17, the claim limitation “the intermediate member includes at least one finger biased radially inward” is unclear because the claim does not specify the structure or mechanism that provides the recited radial bias. It is therefore unclear how the bias-action is provided and, as a result, the metes and bounds of the claim are uncertain.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art, as cited above, fails to disclose a method of delivering an electrical stimulation implant comprising positioning an electrical stimulation implant and an optical component positioned proximal to the electrical stimulation implant, and capturing image data of the cardiac tissue proximate to the distal end portion of a sheath with said optical component in a second position, in combination with the other claimed elements.
Claims 1, 6-8 & 17-20 are not rejected with prior art rejections.
Claims 9-16 are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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