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Claims 1 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/18/2026.
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.
Claims 1-4, 6-10, 12-13 & 17-18 is rejected under 35 U.S.C 103 as being unpatentable over Kallback et al. (US 20160228061) herein referred to as Kallback, in view of Salahieh et al. (US 20170042614) herein referred to as Salahieh.
Regarding Claim 1, Kallback discloses a sheath (Claim 1; Paragraph [0027]; the medical device is a sheath), comprising: an elongated shaft defining a major lumen along a longitudinal axis and having a distal section opposite a proximal section (Claim 1), the shaft including a signal layer (Claim 10; wherein a cylindrical flexible circuit is disposed inside of the shaft); the signal layer having an electrically insulative substrate (Paragraph [0007]; wherein the flexible circuit is made of a dielectric layer, therefore is made of an electrically insulative substrate), an electrically conductive lead trace disposed on the electrically insulative substrate (Paragraph [0049]; wherein the flexible circuit 100 comprises conductive traces disposed on a dielectric layer), and an interface pad exposed on a radially outward surface of the signal layer in the distal section and electrically coupled to the lead trace (Figure 1, 121; Paragraph [0048]; wherein the distal end of the electrical traces are terminated into the solder pads), the lead trace extending in a route from the proximal section to the distal section (Figure 1, 110), and an electrode exposed on the shaft and electrically coupled to the interface pad (Figure 1, 130). However, Kallback does not explicitly disclose the lead trace extending in a curvilinear route.
Salahieh discloses a sheath comprising a signal layer (Figure 1D) wherein the lead trace extends in a curvilinear route (Figure 3D). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the linear route taught by Kallback to be the curvilinear route taught by Salaheih. The motivation being the traces can be created as a sinusoidal line to allow for some elongation of the expandable element so that the individual electrodes can spread farther apart and the electrodes become substantially larger (Salahieh, Paragraph [0130]).
Regarding claim 2, Kallback in view of Salahieh disclose the sheath of claim 1. Kallback also discloses wherein the shaft further includes a spacer disposed around the interface pad and between the interface pad and the electrode (Figure 4, 140)
Regarding claim 3, Kallback in view of Salahieh discloses the sheath of claim 2. Kallback also discloses wherein the spacer is an electrically insulative spacer (Paragraph [0072]; wherein the spacer is made of a biocompatible hydrogel which is seen as electrically insulative).
Regarding claim 4, Kallback in view of Salahieh discloses the sheath of claim 2. Salahieh also discloses wherein the curvilinear route is serpentine (Figure 3D). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the curvilinear route taught by Kallback to be serpentine taught by Salaheih. The motivation being the traces can be created as a sinusoidal line to allow for some elongation of the expandable element so that the individual electrodes can spread farther apart and the electrodes become substantially larger (Salahieh, Paragraph [0130]).
Regarding claim 6, Kallback in view of Salahieh disclose the sheath of claim 1. Kallback also discloses wherein the shaft includes an elongated braided support member disposed between the signal layer and the electrode (Paragraph [0034]; wherein flexible circuit is placed inside shaft material made of a braided polymer shaft such that electrodes would have to be exposed to sample current or impedance therefore the braided polymer would be in between the signal layer and the electrode).
Regarding claim 7, Kallback in view of Salahieh discloses the sheath of claim 6. Kallback also discloses wherein the braided support member includes conductive fibers (Paragraph [0057]; wherein elongated body which is the braid as taught above, can contain electrical wires therefore includes conductive fibers).
Regarding claim 8, Kallback in view of Salahieh disclose the sheath of claim 1. Kallback also discloses wherein the shaft includes an elongated and electrically insulative liner layer disposed radially underneath the signal layer (Figure 2, 105; wherein bottom layer of 105 is seen an the insulative liner layer), the liner layer having an inner wall defining the major lumen (Figure 3)
Regarding claim 9, Kallback in view of Salahieh disclose the sheath of claim 1. Kallback also discloses wherein the lead trace is disposed from the proximal section to the distal section along a radially inward surface of the signal layer (Figure 2, 110)
Regarding claim 10, Kallback in view of Salahieh disclose the sheath of claim 9. Salahieh also discloses wherein the curvilinear route is in a horseshoe pattern (Figure 3A). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the curvilinear route taught by Kallback to be a horse shoe pattern taught by Salaheih. The motivation being the traces can be created as a sinusoidal line to allow for some elongation of the expandable element so that the individual electrodes can spread farther apart and the electrodes become substantially larger (Salahieh, Paragraph [0130]).
Regarding claim 12, Kallback in view of Salahieh disclose the sheath of claim 1. Kallback also discloses wherein the substrate is a flexible and stretchable thermoplastic polyurethane (Paragraph [0037]; wherein the substrate can be made of thermoplastic polymers such that polyurethane is a polymer)
Regarding claim 13, Kallback in view of Salahieh disclose the sheath of claim 1. Kallback also discloses wherein the electrode is electrically coupled to the interface pad via a conductive ink (Paragraph [0075]; wherein conductors may also be formed by ink jet printing or in other ways; Paragraph [0042]; wherein electrical conductors are formed in via holes 140 which connect the interface pads to the electrodes)
Regarding claim 17, Kallback discloses a sheath (Claim 1; Paragraph [0027]; the medical device is a sheath), comprising: an elongated shaft defining a major lumen along a longitudinal axis and having a distal section opposite a proximal section (Claim 1), the shaft including the shaft including a braided support member (Paragraph [0034]; wherein flexible circuit is placed inside shaft material made of a braided polymer shaft such that electrodes would have to be exposed to sample current or impedance therefore the braided polymer would be in between the signal layer and the electrode) and a signal layer (Claim 10; wherein a cylindrical flexible circuit is disposed inside of the shaft); the signal layer having an electrically insulative substrate (Paragraph [0007]; wherein the flexible circuit is made of a dielectric layer, therefore is made of an electrically insulative substrate), an electrically conductive lead trace disposed on the electrically insulative substrate (Paragraph [0049]; wherein the flexible circuit 100 comprises conductive traces disposed on a dielectric layer), and an interface pad exposed on a radially outward surface of the signal layer in the distal section and electrically coupled to the lead trace (Figure 1, 121; Paragraph [0048]; wherein the distal end of the electrical traces are terminated into the solder pads), the lead trace extending in a route from the proximal section to the distal section (Figure 1, 110), the signal layer radially underneath the braided support member (Paragraph [0034]; wherein flexible circuit is placed inside shaft material made of a braided polymer shaft such that electrodes would have to be exposed to sample current or impedance therefore the braided polymer would be in between the signal layer and the electrode); and an electrode radially above the braided support member (Paragraph [0034]; wherein flexible circuit is placed inside shaft material made of a braided polymer shaft such that electrodes would have to be exposed to sample current or impedance therefore the braided polymer would be in between the signal layer and the electrode), exposed on the shaft and electrically coupled to the interface pad (Figure 1, 130). However, Kallback does not explicitly disclose the lead trace extending in a curvilinear serpentine route.
Salahieh discloses a sheath comprising a signal layer (Figure 1D) wherein the lead trace extends in a curvilinear serpentine route (Figure 3D). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the linear route taught by Kallback to be the curvilinear serpentine route taught by Salaheih. The motivation being the traces can be created as a sinusoidal line to allow for some elongation of the expandable element so that the individual electrodes can spread farther apart and the electrodes become substantially larger (Salahieh, Paragraph [0130]).
Regarding claim 18, Kallback in view of Salahieh disclose the sheath of claim 17. Kallback also discloses wherein the shaft includes an elongated and electrically insulative liner layer disposed radially underneath the signal layer (Figure 2, 105; wherein bottom layer of 105 is seen an the insulative liner layer), the liner layer having an inner wall defining the major lumen (Figure 3).
Claim 5 is rejected under 35 U.S.C 103 as being unpatentable over Kallback and Salahieh in view of Hancock et al. (US 20210052317) herein referred to as Hancock.
Regarding Claim 5, Kallback in view of Salahieh disclose the sheath of claim 2. However, Kallback in view of Salahieh does not explicitly disclose wherein the spacer includes ribs.
Hancock discloses a sheath (Figure 2) comprising a spacer that includes ribs (Figure 2, 602). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the spacer discloses by Kallback in view of Salahieh to include ribs. The motivation being to allow for bending and flexures of the spacer which improves the flexibility of the device (Hancock, Paragraph [0115]).
Claim 11 is rejected under 35 U.S.C 103 as being unpatentable over Kallback and Salahieh in view of Highsmith (US 20190336205) herein referred to as Highsmith.
Regarding Claim 11, Kallback in view of Salahieh disclose the sheath of claim 9. However, Kallback in view of Salahieh does not explicitly disclose wherein the lead trace is copper tracing laminated on the substrate.
Highsmith discloses a sheath comprising a signal layer (Figure 4) wherein the lead trace is copper tracing laminated on the substrate (Paragraph [0044]; wherein the flexible circuit is made by laminating thin traces of copper). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the lead trace taught by Kallback in view of Salahieh to be copper tracing laminated on the substrate. The motivation being there is many different methods and materials that can be used to make lead traces (Highsmith, Paragraph [0044]).
Claim 14 is rejected under 35 U.S.C 103 as being unpatentable over Kallback and Salahieh in view of Olson (US 20210361220) herein referred to as Olson.
Regarding Claim 14, Kallback in view of Salahieh disclose the sheath of claim 1 wherein an electrode is electrically coupled to a conductors disposed in conductive ink (Paragraph [0075]; wherein conductors may also be formed by ink jet printing or in other ways; Paragraph [0042]; wherein electrical conductors are formed in via holes 140 which connect the interface pads to the electrodes). However, Kallback in view of Salahieh does not explicitly disclose wherein the electrode is electrically coupled to an electrically conductive spring disposed in the conductive ink.
Olson discloses a sheath comprising a signal layer (Figure 1, 128) wherein the electrode is electrically coupled to an electrically conductive spring disposed in the conductive ink (Paragraph [0042]; wherein the electrical conductors can be springs) . Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrical conductor that is disposed in conductive ink to be a conductive spring as taught by Olson. The motivation being electrical conductors can be wires, conductive routing layers, electrical contacts (e.g., spring contacts or flat contacts) such that they are all seen as interchangeable (Olson, Paragraph [0042]).
Claim 15-16 is rejected under 35 U.S.C 103 as being unpatentable over Kallback and Salahieh in view of Suarez et al. (US 20230181241) herein referred to as Suarez.
Regarding Claim 15, Kallback in view of Salahieh disclose the sheath of claim 1. However, Kallback in view of Salahieh does not explicitly disclose wherein the sheath includes a dilator.
Suarez discloses a sheath (Figure 5) comprising a dilator (Paragraph [0089]; wherein sheath can contain a dilator instrument). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the sheath taught by Kallback in view of Salahieh to include a dilator in the shaft. The motivation being applying a known technique, using a dilator , to a known device, the device disclosed by Kallback in view of Salahieh ready for improvement to yield predictable results of being able to dilate portions of a heart for treatment (MPEP 2143 (D)).
Regarding Claim 16, Kallback in view of Salahieh disclose the sheath of claim 1. However, Kallback in view of Salahieh does not explicitly disclose wherein the electrode is integrally formed with the interface pad.
Suarez discloses a sheath (Figure 5) wherein the electrode is integrally formed with the interface pad (Figure 6 & 7, 544: wherein interface pads are integrally formed underneath the electrodes). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrodes taught by Kallback in view of Salahieh to allow for them to be integrally formed with the interface pads as taught by Suarez. The motivation being any other suitable arrangements and relationships may be used to connect interface pads to electrodes, therefore are all seen as interchangable (Suarez, Paragraph [0061]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
