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Claims 2-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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:
The claim recites, in relevant part, “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.”
The claim fails to clearly set forth the relationship between movement of the optical component and expansion of the distal portion of the elongated sheath. Specifically, it is unclear whether movement of the optical component causes the expansion, triggers the expansion, is required for the expansion or merely occurs contemporaneously with the expansion. As such, the meters and bounds of the claim are not reasonably certain because the nature of the relationship between the recited events is unclear.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art, Wagner et al., Willis et al., etc., (as cited in the ‘reference notes’), either alone or in combination, fails to teach or suggest a delivery system for an electrical stimulation implant including an optical component moveable relative to the electrical stimulation implant between first and second configuration to facilitate direct visualization and image capture of tissue proximate a distal opening during implant delivery.
More particularly, the prior art fails to disclose or suggest the claimed cooperative or suggest the claimed cooperative arrangement and operation between the optical component and the electrical stimulation implant that permits visualization of tissue during delivery of the implant. Accordingly, the claims would be allowable if rewritten to include the limitation(s) overcoming the rejection under 35 U.S.C 112(b).
Response to Arguments
Applicant's arguments filed May 5, 2020 have been fully considered but they are not persuasive. The applicant contends that one or ordinary skill in the art would understand the scope of the claim language reciting the distal portion of the elongated sheath expands “when” the optical component moves from the first configuration to the second configuration. However, the rejection is not based on whether expansion occurs, but rather on the unclear relationship between the recited movement of the optical component and the expansion of the distal portion of the sheath.
The claim does not specify whether movement of the optical component causes the expansion, initiates the expansion, is necessary for the expansion or merely occurs during the same time period. Accordingly, the claim fails to provide reasonable certainty as to the scope of the claimed relationship between these limitations. Therefore, the rejection under 35 U.S. 112(b) maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/NICOLE F JOHNSON/ Primary Examiner, Art Unit 3796
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