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
Applicant’s election without traverse of Group I (claims 1-15) in the reply filed on 06/19/2026 is acknowledged.
Claims 16-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/19/2026.
Remarks
This action is in response to the remarks filed 06/19/2026.
Claims 1-20 are pending, with claims 16-20 withdrawn. Claims 1-15 are examined in the office action below.
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 6, 7, 11, and 12 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.
Claims 6 and 7 recite the limitation "the one or more membranes" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation “the interior and exterior threaded surfaces” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the deformable sleeve” in line 2 and “the sleeve lumen” in line 3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 2, 9, 10, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Grace (US Patent Application Publication 2019/0046788).
Regarding claim 1, Grace discloses a lead extender (e.g. Abstract) comprising: a connector defining a chamber having an inner wall and an opening into the chamber, the chamber configured to receive a proximal portion of a cut implantable medical lead through the opening, wherein the connector comprises a locking mechanism configured to lock the proximal portion of the cut implantable medical lead to the inner wall of the chamber (e.g. Par. [0065]: lead extension device with teeth that prevent movement; Fig. 13); and an extension line, having a distal end attached to the connector, the extension line configured to extend through a lumen of an extraction tool from a distal end to a proximal end of the extraction tool (e.g. Par. [0063]: lead extension device; Par. [0065]; Par. [0070]).
Regarding claim 2, Grace further discloses wherein the connector is configured to move through the lumen of the extraction tool (e.g. Par. [0065]: the device can be moved through the sleeve).
Regarding claim 9, Grace further discloses wherein the locking mechanism comprises an anchor post positioned relative to a distal opening of the connector such that the proximal portion of the cut implantable medical lead may be advanced through the distal opening in a first direction, around the anchor post, and back through the distal opening in a second direction, opposite the first direction (e.g. Par. [0065]).
Regarding claim 10, Grace further discloses wherein the anchor post is a cross- bar extending across the distal opening (e.g. Fig. 13: post 94 is considered to be the anchor).
Regarding claim 12, Grace further discloses wherein the sleeve further comprises one or more protrusions from the inner wall of the sleeve into the sleeve lumen (e.g. Fig. 13).
Regarding claim 14, Grace further discloses wherein the locking mechanism relies on frictional forces induced from feeding the cut implantable medical lead around the anchor post (e.g. Fig. 13: teeth in the device prevent movement).
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.
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 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Grace (US Patent Application Publication 2019/0046788) as applied to claim 1 above, and further in view of Kerr (US Patent Application Publication 2010/0049116).
Regarding claim 8, Grace further discloses wherein the opening comprises an opening of the sleeve lumen, the inner wall comprises an inner wall of the sleeve lumen, and the chamber comprises the sleeve lumen, and wherein the locking mechanism comprises the deformable sleeve deformed toward the longitudinal axis to reduce a volume of the chamber and constrain the proximal portion of the cut implantable medical lead to the inner wall within the chamber (e.g. Fig. 13).
However, Grace fails to disclose wherein the connector comprises: a deformable sleeve comprising a sleeve lumen and an exterior threaded surface; and a compression cap comprising an interior threaded surface configured to align with the exterior threaded surface of the deformable sleeve and defining a compression cap lumen configured to receive at least a portion of the deformable sleeve when the exterior and interior threaded surfaces and threaded together, wherein the deformable sleeve is configured to deform toward a longitudinal axis of the connector when the exterior and interior threaded surfaces are threaded together, and wherein the distal end of the extension line is attached to the compression cap.
Kerr is directed towards a catheter. Kerr discloses a deformable sleeve comprising a sleeve lumen and an exterior threaded surface and a compression cap comprising an interior threaded surface configured to align with the exterior threaded surface of the deformable sleeve and defining a compression cap lumen configured to receive at least a portion of the deformable sleeve when the exterior and interior threaded surfaces and threaded together, wherein the deformable sleeve is configured to deform toward a longitudinal axis of the connector when the exterior and interior threaded surfaces are threaded together, and wherein the distal end of the extension line is attached to the compression cap (e.g. Pars. [0062]-[0063]: the sleeve 44 and cap 32 contains threaded portions that can be attached together; Fig. 1A).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace to include the deformable threaded sleeve and compression cap as taught by Kerr because doing so would allow the connector to lock in to place and prevent additional movement.
Regarding claim 15, Grace fails to disclose wherein the compression cap may form a single contiguous piece with the deformable sleeve. Kerr is directed towards a catheter. Kerr discloses wherein the compression cap may form a single contiguous piece with the deformable sleeve (e.g. Par. [0019]: the sleeve and cap are pre-assembled together to prevent axial movement).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Kerr to include the compression cap forming a single piece with the sleeve as taught by Kerr because doing so would prevent axial movement (e.g. Kerr, par. [0019]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Grace (US Patent Application Publication 2019/0046788) as applied to claim 1 above, and further in view of Cobbley at al. (US Patent Application Publication 2003/0203668), hereinafter Cobbley.
Regarding claim 11, Grace fails to disclose wherein at least one of the interior and exterior threaded surfaces further comprises a compression activated epoxy bladder configured to release epoxy when the interior and exterior threaded surfaces are threaded together. Cobbley is directed towards electrical interconnects. Cobbley discloses using compression activated epoxy for attachment (e.g. Pars. [0041]-[0042]: epoxy released when there is compression).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace to include the compression activated epoxy as taught by Cobbley because doing so would allow effective attachment of the parts.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Grace (US Patent Application Publication 2019/0046788) as applied to claim 1 above.
Regarding claim 13, Grace further discloses wherein the cross- bar may be a beveled cross-bar for looping or advancing the proximal portion of the cut implantable medical lead around the cross-bar (e.g. Fig. 13: post 94 is considered to be the anchor). Grace discloses the claimed invention but does not disclose expressly the cross-bar including a notch or tapered portion. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the invention as taught by Grace with the cross-bar including a notch or tapered portion, because Applicant has not disclosed that cross-bar including a notch or tapered portion provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the cross-bar as taught by Grace, because it provides the same purpose of looping or advancing the lead and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Grace. Therefore, it would have been an obvious matter of design choice to modify Grace to obtain the invention as specified in the claim.
Allowable Subject Matter
Claims 3-5 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. Regarding claim 3, no prior art was found teaching individually or suggesting the limitations of “the connector comprises one or more rupturable membrane seals defining one or more epoxy bladders within the chamber, wherein the locking mechanism comprises an inactivated epoxy contained within the one or more epoxy bladders”. Claims 4 and 5 depend on claim 3.
Claims 6 and 7 depend on claim 3 and would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Allen et al. (US 2006/0115335) is directed towards using epoxy bladders.
Hanson et al. (US 2021/0111525) is directed towards connector assemblies for medial lead extensions.
Kerr (US 2008/0108969) is directed towards a catheter.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
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