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 .
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 9, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Garai et al (US Publication 2022/0273958).
Referring to Claim 1, Garai et al teaches a system comprising: an electrical lead (e.g. Figure 1A, lead 110); an implantable medical device, wherein the electrical lead is electrically connected to the implantable medical device, and the implantable medical device is configured to deliver an electrical therapy to tissue of a patient via the electrical lead (e.g. Paragraphs [0021], [0026], and [0084]); a sheath configured to be at least partially disposed within vasculature of the patient and configured to receive the electrical lead such that a distal portion of the electrical lead is placed within the vasculature through the sheath (e.g. Paragraph [0078] and Figure 1C); and a lead management device connected to the implantable medical device and the sheath, wherein the lead management device is configured to secure an excess portion of the electrical lead, and wherein the lead management device is configured to control movement of the electrical lead within the vasculature of the patient (e.g. Figures 7A-7B and 9A-9C retention device 700 or 900).
Referring to Claim 9, Garai et al teaches the system of claim 1, further comprising an expandable member disposed over the implantable medical device and the lead management device, wherein the expandable member is configured to isolate the implantable medical device and the lead management device from tissue of the patient (e.g. Figure 1C, Element 170 and Paragraph [0108]).
Referring to Claim 13, Garai et al teaches the system of claim 1, wherein the sheath anchors the electrical lead within the vasculature of the patient (e.g. Figure 1C, Element 160).
Claim(s) 16-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams et al (US Patent 9,427,575).
Referring to Claim 16, Williams et al teaches a lead management device comprising: a first pocket configured to retain an implantable medical device (e.g. Figure 8C, pocket 258); and a second pocket configured to retain an excess portion of an electrical lead, wherein the electrical lead is electrically connected to the implantable medical device, and wherein the electrical lead is configured to be disposed within a vasculature of a patient and to deliver a medical therapy to tissue of the patient (e.g. Figure 8C, pocket 259. The examiner notes that the pockets are configured to retain an electrical lead and the claim does not positively recite the electrical lead).
Referring to Claim 17, Williams et al teaches the lead management device of claim 16, wherein the first pocket and the second pocket are arranged in a side-by-side configuration (e.g. Figure 8C).
Referring to Claim 18, Williams et al teaches the lead management device of claim 16, wherein the lead management device is configured to control movement of the electrical lead within the vasculature of the patient by securing the excess portion of the electrical lead in a storage configuration within the second pocket (e.g. Figure 8C).
Referring to Claim 19, Williams et al teaches the lead management device of claim 16, wherein the first pocket comprises a housing of the implantable medical device (e.g. Figure 8C).
Claim(s) 21 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezai et al (US Publication 2005/0015128).
Referring to Claim 21, Rezai et al teaches a lead management device comprising: an elongated body defining: a central groove extending from a proximal end of the elongated body to a distal end of the elongated body, wherein the central groove is configured to retain a first portion of an electrical lead connected to an implantable medical device (e.g. Figure 4A, central groove 415)); and a plurality of grooves disposed around the central groove and configured to retain a second portion of the electrical lead (e.g. Figured 4A grooves around central groove 430), wherein the lead management device is configured to control movement of the electrical lead (e.g. Figured 4A grooves around central groove 430).
Referring to Claim 24, Rezai et al teaches the lead management device of claim 21, wherein the lead management device is configured to control a length of the electrical lead within the vasculature of the patient by securing the second portion of the electrical lead in a storage configuration within the plurality of grooves (e.g. Figured 4A grooves around central groove 430).
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.
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.
Claim(s) 2-5 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by Garai et al (US Publication 2022/0273958) or, in the alternative, under 35 U.S.C. 103 as obvious over Garai et al (US Publication 2022/0273958) in view of Williams et al (US Patent 9,427,575).
Referring to Claim 2, Garai et al teaches the system of claim 1, wherein the lead management device includes one or more recesses configured to receive and secure the excess portion of the electrical lead in a storage configuration (e.g. Figures 7A and 7B).
In the alternative, that the lead management does not disclose a recess/pocket to retain excess portion of the lead. Williams et al teaches that it is known to use two pockets within the same structure for holding elongate members (leads) as set forth in Figure 8C to provide separate cavities to hold different leads to reduce the likelihood of entanglement between the leads. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with one or more recesses configured to receive and secure the excess portion of the electrical lead in a storage configuration as taught by Williams et al, since such a modification would provide the predictable results of separate cavities to hold different leads to reduce the likelihood of entanglement between the leads.
Referring to Claim 3, Garai et al teaches the system of claim 1, wherein the lead management device defines a pocket configured to retain the excess portion of the electrical lead in the storage configuration (e.g. Figure 9C, Element 935).
In the alternative, that the lead management does not disclose a recess/pocket to retain excess portion of the lead. Williams et al teaches that it is known to use two pockets within the same structure for holding elongate members (leads) as set forth in Figure 8C to provide separate cavities to hold different leads to reduce the likelihood of entanglement between the leads. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with a pocket configured to retain the excess portion of the electrical lead in the storage configuration as taught by Williams et al, since such a modification would provide the predictable results of separate cavities to hold different leads to reduce the likelihood of entanglement between the leads.
Referring to Claim 4, Garai et al or Garai et al in view of Williams et al teaches the system of claim 3, wherein the lead management device comprises a holster defining a first pocket configured to retain the implantable medical device and a second pocket configured to retain the excess portion of the electrical lead in the storage configuration (e.g. Figure 9B, Element 900 and Figure 9C, Element 935 left and right side and Paragraph [0089).
In the alternative, that the lead management does not disclose a recess/pocket to retain excess portion of the lead. Williams et al teaches that it is known to use two pockets within the same structure for holding elongate members (leads) as set forth in Figure 8C to provide separate cavities to hold different leads to reduce the likelihood of entanglement between the leads. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with a holster defining a first pocket configured to retain the implantable medical device and a second pocket configured to retain the excess portion of the electrical lead in the storage configuration as taught by Williams et al, since such a modification would provide the predictable results of separate cavities to hold different leads to reduce the likelihood of entanglement between the leads.
Referring to Claim 5, Garai et al in view of Williams et al teaches the system of claim 4, except wherein the second pocket defines a groove configured to secure the excess portion of the electrical lead. Williams et al teaches that it is known to use the pocket defines a groove configured to secure the excess portion of the electrical lead as set forth in Figure 8C to provide separate cavities to hold different leads to reduce the likelihood of entanglement between the leads. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with the pocket defines a groove configured to secure the excess portion of the electrical lead as taught by Williams et al, since such a modification would provide the predictable results of separate cavities to hold different leads to reduce the likelihood of entanglement between the leads.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garai et al (US Publication 2022/0273958) in view of Rezai et al (US Publication 2005/0015128).
Referring to Claim 6, Garai et al teaches the system of claim 1, except wherein the lead management device comprises an elongated body defining: a central groove extending from a proximal end of the elongated body to a distal end of the elongated body, the central groove being configured to retain the electrical lead and dispose the electrical lead within the sheath; and a plurality of grooves disposed around the central groove and configured to retain the excess portion of the electrical lead. Rezai et al teaches that it is known to use a central groove extending from a proximal end of the elongated body to a distal end of the elongated body, the central groove being configured to retain the electrical lead and dispose the electrical lead within the sheath (e.g. Figure 4A, central groove 415); and a plurality of grooves disposed around the central groove and configured to retain the excess portion of the electrical lead (e.g. Figured 4A grooves around central groove 430) to provide retention management of the excess lead to reduce MRI safety concerns and improved ease of revision surgery. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with an elongated body defining: a central groove extending from a proximal end of the elongated body to a distal end of the elongated body, the central groove being configured to retain the electrical lead and dispose the electrical lead within the sheath; and a plurality of grooves disposed around the central groove and configured to retain the excess portion of the electrical lead as taught by Rezai et al, since such a modification would provide the predictable results of retention management of the excess lead to reduce MRI safety concerns and improved ease of revision surgery.
Referring to Claim 7, Garai et al in view of Rezai et al teaches the system of claim 6, except wherein the plurality of grooves form a helical recess around an outer surface of the elongated body. Rezai et al teaches that it is known to use wherein the plurality of grooves form a helical recess around an outer surface of the elongated body (e.g. Figured 4A grooves around central groove 430) to provide retention management of the excess lead to reduce MRI safety concerns and improved ease of revision surgery. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with wherein the plurality of grooves form a helical recess around an outer surface of the elongated body as taught by Rezai et al, since such a modification would provide the predictable results of retention management of the excess lead to reduce MRI safety concerns and improved ease of revision surgery.
Referring to Claim 8, Garai et al in view of Rezai et al teaches the system of claim 6,except wherein the plurality of grooves are parallel to the central groove.
Rezai et al teaches that it is known to use a central groove extending from a proximal end of the elongated body to a distal end of the elongated body, the central groove being configured to retain the electrical lead and dispose the electrical lead within the sheath (e.g. Figure 4A, central groove 415); and a plurality of grooves disposed around the central groove and configured to retain the excess portion of the electrical lead; wherein the plurality of grooves are parallel to the central groove (e.g. Figured 4A grooves around central groove 430) to provide retention management of the excess lead to reduce MRI safety concerns and improved ease of revision surgery. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with an elongated body defining: a central groove extending from a proximal end of the elongated body to a distal end of the elongated body, the central groove being configured to retain the electrical lead and dispose the electrical lead within the sheath; and a plurality of grooves disposed around the central groove and configured to retain the excess portion of the electrical lead; wherein the plurality of grooves are parallel to the central groove as taught by Rezai et al, since such a modification would provide the predictable results of retention management of the excess lead to reduce MRI safety concerns and improved ease of revision surgery.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garai et al (US Publication 2022/0273958) in view of Gerber (US Publication 2008/0103575).
Referring to Claim 14, Garai et al teaches the system of claim 1,wherein the sheath comprises: an elongated body defining a sheath lumen configured to receive the electrical lead (e.g. Figure 1C). However, Garai et al does not disclose one or more valves disposed within the sheath lumen, the one or more valves configured to restrict flow of bodily fluids within the sheath lumen.
Gerber teaches that it is known to use one or more valves disposed within the sheath lumen, the one or more valves configured to restrict flow of bodily fluids within the sheath lumen as set forth in Figures 3A or 3B and valve 69 and Paragraph [0062] to provide controlling the flow of fluid. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Garai et al, with one or more valves disposed within the sheath lumen, the one or more valves configured to restrict flow of bodily fluids within the sheath lumen as taught by Gerber, since such a modification would provide the predictable results of controlling the flow of fluid.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al (US Patent 9,427,575) in view of Garai et al (US Publication 2022/0273958).
Referring to Claim 20, Williams et al teaches the lead management device of claim 16, except further comprising an expandable member disposed over the first pocket and the second pocket, wherein the expandable member is configured to isolate the implantable medical device and the electrical lead from the tissue of the patient.
Garai et al teaches that it is known to use an expandable member disposed over an implantable medical device, wherein the expandable member is configured to isolate the implantable medical device and the electrical lead from the tissue of the patient as set forth in Figure 1C, Element 170 and Paragraph [0108] to provide assisting in stabilizing the device at the appropriate position. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Williams et al, with an expandable member disposed over an implantable medical device, wherein the expandable member is configured to isolate the implantable medical device and the electrical lead from the tissue of the patient as taught by Garai et al, since such a modification would provide the predictable results of assisting in stabilizing the device at the appropriate position.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rezai et al (US Publication 2005/0015128) in view of Garai et al (US Publication 2022/0273958)
Referring to Claim 22, Rezai et al teaches the lead management device of claim 21, wherein the proximal end of the elongated body is connected to the implantable medical device (e.g. Paragraph [0002] discloses IPG provides electronic pulses to the lead). However, Rezai et al does not discloses wherein the distal end of the elongated body is connected to a sheath configured to retain the electrical lead.
Garai et al teaches that it is known to use the distal end of the elongated body is connected to a sheath configured to retain the electrical lead as set forth in Paragraph [0078] and Figure 1C to provide the delivery of electrical stimulation to the patient by retaining the lead and electrode in connection with the tissue. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Rezai et al, with the distal end of the elongated body is connected to a sheath configured to retain the electrical lead as taught by Garai et al, since such a modification would provide the predictable results of delivery of electrical stimulation to the patient by retaining the lead and electrode in connection with the tissue.
Allowable Subject Matter
Claim 23 is 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Severseike et al (US Publication 2026/0124443) discloses an expandable member to be placed over excess portions of the lead. Chardack (US Patent 3,598,128) discloses releasable storage of a lead.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/William J Levicky/Primary Examiner, Art Unit 3796
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