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 § 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 6-10 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.
In claim 6, it is unclear what “a groove defined in an out surface of the catheter” is unclear and doesn’t make sense. It is treated as “an outer surface”.
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) 1-5, 11, 12, 14, 17, 19-23 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Killeen et al (US 2020/0360666).
Regarding claim 1, Killeen discloses a centering device (fig 1) configured to access a vasculature of a patient (abstract), comprising: a catheter 10 including an elongate body 12 defining a lumen 34 communicating with an opening disposed adjacent a distal tip thereof (fig 1, see step 706 in fig 7); and a centering device transitionable between a retracted configuration and an extended configuration (¶20 – “wires configured to expand radially outward from the catheter), the centering device in the extended configuration configured to distance a distal tip of the catheter from a wall of the vasculature (¶20 – “re-center the catheter in the vessel”), the centering device including a wire 22 extending longitudinally along an outer surface of the catheter (fig 1) and slidably engaged therewith (¶30 – “push and/or pull support wires 22”), the wire comprising: a distal tip coupled to a distal portion of the catheter (at 24 as per ¶23, fig 1); an expandable portion disposed proximate the distal tip of the catheter (fig 1) and configured to transition between the retracted configuration and the extended configuration (¶20, ¶30); and a proximal portion 16 configured to remain external to the patient (for controlling wires and attachment to medical connectors).
Regarding claim 2, wherein the wire includes one of a shape memory material or nitinol (¶70).
Regarding claim 3, wherein the expandable portion is elastically deformable from the retracted configuration to the extended configuration (¶30, also see shape memory material of ¶70).
Regarding claim 4, wherein the expandable portion includes a hinge or a living hinge (hinges about fixed constraint 24).
Regarding claim 5, wherein the proximal portion is slidable along a longitudinal axis between the retracted configuration and the extended configuration (¶30).
Regarding claim 11, wherein a portion of the wire extends through a wire lumen extending through a wall of the catheter (fig 2B).
Regarding claim 12, further includes a loop 40 formed integrally with the catheter body and configured to receive a portion of the wire extending therethrough (fig 2B).
Regarding claim 14, further including an abutment 26 formed integrally with the catheter, the distal tip of the wire configured to abut against the abutment and prevent further distal movement of the distal tip relative to the catheter (fig 3A, ¶26).
Regarding claim 17, wherein an apex of the expandable portion in the extended configuration is disposed radially outward from a central longitudinal axis relative to the retracted configuration (fig 1).
Regarding claim 19, wherein the distal tip of the wire is disposed proximal of the distal tip of the catheter (fig 1).
Regarding claim 20, wherein the distal tip of the wire is disposed a second distance from the distal tip (1 mm to about 10 cm as per ¶27), the second distance being less than two times the diameter of the lumen (lumen is about 4 Fr to about 10 Fr as per ¶37; which is about 1.33 mm to about 3.33 mm; thus in the minimum embodiment of 1 mm it will be less than two times the diameter of the lumen).
Regarding claim 21, wherein the proximal portion is disposed adjacent a bifurcation of the catheter (catheter is split into different lumens 40 which is disposed adjacent the proximal portion 16 of catheter).
Regarding claim 22, wherein the expandable portion in the extended configuration is configured to distend a vessel wall to a larger diameter along a first axis extending perpendicular to a longitudinal axis (via wires contacting vessel wall when expanded as per ¶20).
Regarding claim 23, wherein the centering device in the extended configuration is configured to prevent a distal tip of the catheter from contacting a wall of the vasculature (¶20).
Regarding claim 25, wherein the lumen of the catheter is fluid locked between a hub disposed at a proximal end of the elongate body and a distal tip (due to only exits from catheter being at proximal end and distal tip).
Claim(s) 1-10, 14, 16, 17, 19 and 21-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fortson (US 10,980,981)
Regarding claim 1, Fortson discloses a centering device configured to access a vasculature of a patient, comprising: a catheter 102 including an elongate body defining a lumen 208 (fig 4B) communicating with an opening disposed adjacent a distal tip thereof (fig 4C); and a centering device 404 (fig 7A) transitionable between a retracted configuration (fig 4A) and an extended configuration (figs 6A and 7A), the centering device in the extended configuration configured to distance a distal tip of the catheter from a wall of the vasculature (fig 7B), the centering device including a wire 404 extending longitudinally along an outer surface of the catheter and slidably engaged therewith (fig 4A; Col.11 ll 32-36), the wire comprising: a distal tip coupled to a distal portion of the catheter (fig 4A); an expandable portion disposed proximate the distal tip of the catheter and configured to transition between the retracted configuration (fig 4A) and the extended configuration (fig 6A); and a proximal portion 110 configured to remain external to the patient (so that a caregiver may access and control the device; further, device does not need to be fully inserted).
Regarding claim 2, wherein the wire includes one of a shape memory material or nitinol (Col.11 ll 11-14).
Regarding claim 3, wherein the expandable portion is elastically deformable from the retracted configuration to the extended configuration (Col.11 ll 5).
Regarding claim 4, wherein the expandable portion includes a hinge or a living hinge (hinges about distal most point attached to tip 112, fig 6A).
Regarding claim 5, wherein the proximal portion is slidable along a longitudinal axis between the retracted configuration and the extended configuration (figs 10 and 11).
Regarding claim 6, wherein a portion of the wire is disposed within a groove defined in an out surface of the catheter (fig 4A).
Regarding claim 7, further including the expandable portion of the wire disposed within the groove when the wire is in the retracted configuration (fig 4A).
Regarding claim 8, further including the proximal portion of the wire disposed within the groove and slidably engaged therewith (fig 11).
Regarding claim 9, wherein a radial depth of the groove is equal to a thickness of the wire (fig 5B).
Regarding claim 10, further including a bridge 404 formed integrally with the catheter body and extending across the groove, perpendicular thereto, the bridge configured to retain a portion of the wire within the groove.
Regarding claim 14, further including an abutment 112 formed integrally with the catheter, the distal tip of the wire configured to abut against the abutment and prevent further distal movement of the distal tip relative to the catheter (fig 7B).
Regarding claim 16, further including a push-button actuating mechanism 1008 configured to transition the wire between the retracted configuration and the extended configuration (figs 10 and 11).
Regarding claim 17, wherein an apex of the expandable portion in the extended configuration is disposed radially outward from a central longitudinal axis relative to the retracted configuration (figs 4A and 6A).
Regarding claim 19, wherein the distal tip of the wire is disposed proximal of the distal tip of the catheter (fig 5A).
Regarding claim 21 wherein the proximal portion is disposed adjacent a bifurcation of the catheter (fig 11, disposed adjacent outer grooves, which are bifurcations).
Regarding claim 22, wherein the expandable portion in the extended configuration is configured to distend a vessel wall to a larger diameter along a first axis extending perpendicular to a longitudinal axis (Col.11 ll 56-61).
Regarding claim 23, wherein the centering device in the extended configuration is configured to prevent a distal tip of the catheter from contacting a wall of the vasculature (fig 7B).
Regarding claim 24, further including a second expandable portion disposed axially relative to the expandable portion, the second expandable portion including a second apex contacting a vessel wall at a different longitudinal configuration from the first apex (fig 7B).
Regarding claim 25, wherein the lumen of the catheter is fluid locked between a hub disposed at a proximal end of the elongate body and a distal tip (in retracted configuration, due to wires blocking all exits from the catheter between the distal tip and proximal end of elongate body in the retracted configuration).
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.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Killeen et al (US 2020/0360666).
Regarding claim 15, while Killeen substantially discloses the invention as claimed, it does not disclose wherein the proximal portion of the wire is coupled to a second proximal portion of a second wire to form a loop, the loop configured to be advanced distally to transition one of the wire or the second wire between the retracted configuration and the extended configuration.
In fig 1 of Killeen, the control members 17 are disclosed as slidable levers (¶30). It is unclear how the control members are attached to the wires. One of ordinary skill in the art would appreciate the two most likely ways of attaching the levers and wires are crimping the wire to the lever, or looping an end of the wire around a peg or other projection of the level.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Killeen such that the proximal portion of the wire is coupled to a second proximal portion of a second wire to form a loop, the loop configured to be advanced distally to transition one of the wire or the second wire between the retracted (as part of a loop attachment between the wire and control member) configuration and the extended configuration as suggested by Killeen as it is a known, specific means by which to attach the wire to the control member.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Killeen et al (US 2020/0360666) or Fortson (US 10,980,981).
Regarding claim 18, while both references substantially disclose the invention as claimed, neither Killeen nor Fortson disclose an apex is disposed a first distance from the distal tip, the first distance being less than three times the diameter of the lumen.
Both references disclose using the wires (and apex of said wires) to center the device within the lumen (see various citations in the 102 rejections). It would have been obvious via routine experimentation to determine an appropriate distance place the apex in order to properly center the device.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to determine an appropriate location (for either/both Killeen and Fortson) such that an apex is disposed a first distance from the distal tip, the first distance being less than three times the diameter of the lumen, in order to properly center the catheter, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233 (CCPA 1955).
Allowable Subject Matter
Claim 13 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.
The examiner did not find a teaching or suggestion for modifying either of the closest art Killeen and Fortson such that a lumen of the loop is angled relative to the longitudinal axis, absent impermissible hindsight.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783