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
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 11-12, and 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dance (US 5117839 A).
Regarding claim 1, Dance discloses an elongate steerable medical device (catheter 10, Fig 1), comprising: a shaft (catheter body 12, Fig 1) comprising: an elongate outer member (Outer surface of catheter body 12, Fig 1); and an elongate inner member (guidewire 16, Fig 1) slidingly disposed within the elongate outer member (Outer surface of catheter body 12, Fig 1); and a handle assembly (1000, Annotated Fig 1) removably securable to the shaft (12), the handle assembly (1000, Annotated Fig 1) comprising: a handle body (body of handle assembly 1000, Annotated Fig 1) including a proximal handle (1001, Annotated Fig 1); a spool (guidewire fixation knob 54, Fig 1) slidingly and releasably securable to the handle body (body of handle assembly 1000, Fig 1), the spool (54) adapted to be releasable securable to the elongate inner member (16) (Col 4, lines 34-43); a knob (guidewire rotation knob 52, Fig 1) that is rotatably and releasably securable to the handle body (body of handle assembly 1000, Annotated Fig 1) (Col 4, lines 22-33), the knob (52) adapted to be releasably securable to the elongate inner member (16) such that rotation of the knob (52) relative to the handle body (body of handle assembly 1000, Annotated Fig 1) causes rotation of the elongate inner member (16); a collet (rigid threaded nut 28, Fig 1) removably securable to a distal end (1001, Annotated Fig 1) of the handle body (body of handle assembly 1000, Annotated Fig 1), the collet (28) adapted to releasably secure the elongate outer member (12) relative to the collet (28) (Col 3, lines 34-35); wherein movement of the spool (54) relative to the handle body (body of handle assembly 1000, Annotated Fig 1) causes the elongate inner member (16) to move relative to the elongate outer member (12).
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Regarding claim 11, Dance discloses the elongate steerable medical device of claim 1. Dance discloses wherein the elongate inner member (16) further comprises a crimp sleeve (compressible fixation device 60, Fig 2) secured to the proximal portion of the elongate inner member (16) (Fig 2).
Regarding claim 12, Dance discloses the elongate steerable medical device of claim 11, wherein the spool (54) defines an interior cavity (1005, Annotated Fig 2) adapted to accommodate the crimp sleeve (60) therein in order to secure the proximal portion (1003, Annotated Fig 1) of the elongate inner member (16) relative to the spool (54).
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Regarding claim 15, Dance discloses the elongate steerable medical device of claim 1, wherein the distal end (1002, Annotated Fig 1) of the handle body (body of handle 1000, Annotated Fig 1) includes a threaded outer surface (1006, Annotated Fig 1) and a cavity (portion of inner lumen 26 pertaining to the section of threading) defined by the threaded outer surface (1006, Annotated Fig 1).
Regarding claim 16, Dance discloses the elongate steerable medical device of claim 15, wherein the collet (28) comprises: a tapered inner collet section (1007, Annotated Fig 3) disposed within the cavity (cavity formed between 28 and distal end 1002 of handle 1000); and an outer collet section (1008, Annotated Fig 3) threadedly engaged with the threaded outer surface (1006, Annotated Fig 1) and thus securing the elongate outer member (12) relative to the tapered inner collet section (1007, Annotated Fig 3).
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Regarding claim 17, Dance discloses the elongate steerable medical device of claim 1, wherein the shaft (12)comprises a guidewire (16)(Fig 1).
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 2-7, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Dance (US 5117839 A) in view of Lorenzo (EP 0823261 A2) in further view of Eskuri (US 20050065456 A1).
Regarding claim 2, Dance discloses the elongate steerable medical device of claim 1, wherein the elongate inner member (16) comprises: an elongate core wire (guidewire 16, Fig 1): a proximal portion (1003, Annotated Fig 1) that extends proximally from the elongate outer member (12) ; and distal portion (1004, Annotated Fig 4); and a sheath (inner sheath 14, Fig 1) extending over the elongate core wire (16).
Dance is silent regarding an asymmetric distal portion having a semi-circular cross-sectional profile; wherein the asymmetric distal portion is secured to the sheath.
Lorenzo teaches a medical device (Figs 5-6) comprising an elongate core wire (Core wire 160, Fig 6) comprising an asymmetric distal portion having a semi-circular cross-sectional profile (semicircular cross section; Fig 6); and a sheath (outer tube 120, Fig 6) extending over the elongate core wire (160);
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance with similar semi-circular profile as taught by Lorenzo to create a channel for passage of fluid therethrough (Col 4, lines 39-41).
Dance/Lorenzo are silent wherein the asymmetric distal portion is secured to the sheath.
Eskuri teaches a medical device (Figs 5-6) comprising an elongate core wire (14) wherein an asymmetric distal portion ([0042]: “For example, the cross-sectional shape of core wire 14 may be oval, rectangular, square, polygonal, and the like, or any suitable shape.”) is secured to the sheath ([0061]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo with similar polymeric sheath attached to the core member as taught by Eskuri to provide strength, flexibility or other desired characteristics ([0061]).
Regarding claim 3, Dance/Lorenzo/Eskuri disclose the elongate steerable medical device of claim 2. Dance is silent wherein the sheath comprises one or more polymeric layers extending over the elongate core wire.
Eskuri teaches a medical device (Figs 5-6) comprising an elongate core wire (14) wherein the sheath (170) comprises one or more polymeric layers extending over the elongate core wire ([0061]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo/Eskuri with similar polymeric sheath attached to the core member as taught by Eskuri to provide strength, flexibility or other desired characteristics ([0061]).
Regarding claim 4, Dance/Lorenzo/Eskuri disclose the elongate steerable medical device of claim 2. Dance is silent wherein the sheath further comprises a braided layer.
Eskuri discloses wherein the sheath further comprises a braided layer (helically wrapped wire 560, Fig 11; ([0037]; [0058]-[0059]; [0071]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo/Eskuri with similar braided layer coated with radiopaque material as taught by Eskuri to provide visualization under imaging techniques ([0065]).
Regarding claim 5, Dance/Lorenzo/Eskuri disclose the elongate steerable medical device of claim 2. Dance is silent wherein at least a portion of the sheath comprises a laser cut hypotube.
Eskuri wherein at least a portion of the sheath comprises a laser cut hypotube ([0037];[0040] discloses hypotube as a suitable structure as alternative to the coiled wire).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo/Eskuri with similar radiopaque hypotube as taught by Eskuri to provide visualization under imaging techniques ([0037];[0040]; [0065]).
Regarding claim 6, Dance/Lorenzo/Eskuri disclose the elongate steerable medical device of claim 2. Dance is silent wherein the sheath comprises a distal sleeve that is disposed over and secured to the asymmetric distal portion of the elongate core wire.
Eskuri teaches wherein the sheath comprises a distal sleeve (distal portion of polymer sheath 170, Fig 7) that is disposed over and secured to the asymmetric distal portion of the elongate core wire (core wire 114, Fig 7;[0042]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo/Eskuri having a similar distal protion of sleeve secured and disposed over the asymmetrical distal portion as taught by Eskuri to provide strength, flexibility or other desired characteristics ([0061]).
Regarding claim 7, Dance/Lorenzo/Eskuri disclose the elongate steerable medical device of claim 2. Dance is silent wherein the sheath comprises a proximal sleeve disposed over the proximal portion of the elongate core wire.
Eskuri teaches wherein the sheath (170) comprises a proximal sleeve (proximal portion of sheath 170; [0061]; sleeve can have a length up to 25in) disposed over the proximal portion of the elongate core wire (proximal portion of sheath 170 in its maximum length would cover a proximal portion core wire 114).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo/Eskuri having a similar distal protion of sleeve secured and disposed over the asymmetrical distal portion as taught by Eskuri to provide strength, flexibility or other desired characteristics ([0061]).
Regarding claim 20, Dance discloses a steerable guidewire assembly (Fig 1), comprising: a steerable guidewire (catheter body 12+ inner sheath 14 + guidewire 16, Fig 1) comprising: an elongate outer member (Outer surface of catheter body 12, Fig 1); an elongate inner member (guidewire 16, Fig 1) slidingly disposed within the elongate outer member (Outer surface of catheter body 12, Fig 1), the elongate inner member (16) including: a proximal portion (1003, Annotated Fig 1) that extends proximally from the elongate outer sheath (12); and a sheath (inner sheath 14, Fig 1) extending over the elongate inner member (16); a handle assembly (1000, Annotated Fig 1) removeably securable to the steerable guidewire (12+14+16), the handle assembly (1000, Annotated Fig 1)comprising: a handle body (body of handle assembly 1000, Annotated Fig 1) including a proximal handle (1001, Annotated Fig 1); a spool (54) slidingly securable to the handle body (body of handle assembly 1000, Annotated Fig 1), the spool (54) adapted to enable translation of the elongate inner member (16) (Fig 5); a knob (guidewire rotation knob 52, Fig 1) rotatably securable to the handle body (body of handle assembly 1000, Annotated Fig 1), the knob (52) adapted to enable rotation of the elongate inner member (16) (Fig 4); a collet (rigid threaded nut 28, Fig 1) removably securable to a distal end (1002, Annotated Fig 1) of the handle body (body of handle assembly 1000, Annotated Fig 1), the collet (28) adapted to releasably secure the elongate outer member (12) relative to the collet (28); wherein relative movement of the spool (54) and/or the knob (52) facilitates steering of the steerable guidewire (12+14+16).
Dance is silent regarding the elongate inner member including an asymmetric distal portion having a semi-circular cross-sectional profile; the asymmetric distal portion secured to the sheath
Lorenzo teaches a steerable guidewire assembly (guidewire 110, Figs 5-6) comprising an elongate inner member (Core wire 160, Fig 6) the elongate inner member (160) including an asymmetric distal portion having a semi-circular cross-sectional profile (semicircular cross section; Fig 6).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance with similar semi-circular profile as taught by Lorenzo to create a channel for passage of fluid therethrough (Col 4, lines 39-41).
Dance/Lorenzo are silent wherein the asymmetric distal portion is secured to the sheath.
Eskuri teaches a medical device comprising an elongate core wire (14) wherein an asymmetric distal portion ([0042]: “For example, the cross-sectional shape of core wire 14 may be oval, rectangular, square, polygonal, and the like, or any suitable shape.”) is secured to the sheath ([0061]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo with similar polymeric sheath attached to the core member as taught by Eskuri to provide strength, flexibility or other desired characteristics ([0061]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Dance (US 5117839 A). in view of Lorenzo (EP 0823261 A2) in further view of Eskuri (US 20050065456 A1) in further view of Sharrow et al. (US 20040167437 A1).
Regarding claim 8, Dance/Lorenzo/Eskuri disclose the elongate steerable medical device of claim 2. Dance is silent wherein the asymmetric distal portion of the elongate core wire comprises a flexibility-enhancing pattern formed therein.
Sharrow teaches a medical device ([0055]) comprising a the asymmetric ([0042]) distal portion of the elongate core wire (core wire 17b; [0055]) comprises a flexibility-enhancing pattern formed therein (Fig 18).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Lorenzo/Eskuri with similar slot pattern as taught by Sharrow for the purpose of increasing in lateral flexibility ([0055])
Claims 9-10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Dance (US 5117839 A) in view of Measamer (US 20070244512 A1).
Regarding claim 9, Dance discloses the elongate steerable medical device of claim 1. Dance is silent wherein the spool comprises a first spool half and a second spool half that are adapted to releasably snap together to slidingly secure the spool to the handle body with the proximal portion of the elongate inner member extending therethrough.
Measamer teaches elongate steerable medical device (Fig 1) comprising a spool (spool 56, Fig 2)wherein the spool comprises a first spool half and a second spool half (spool 56 halves; [0036]) that are adapted to releasably snap together ([0036]: halves joined by press pins 62) to slidingly secure the spool (56) to the handle body (handle assembly 50, Fig 2) with the proximal portion of the elongate inner member (actuator member 46, Fig 1) extending therethrough ([0037]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the spool device of Dance to be split in halves and secure the inner member when joined as taught by Measamer for the purpose of securing and facilitating displacing the inner member ([0036]-[0037]).
Regarding claim 10, Dance/Measamer discloses the elongate steerable medical device of claim 9. Dance is silent wherein the first spool half and the second spool half are adapted to separate from each other and the handle body in order to allow release of the proximal portion of the elongate inner member.
Measamer teaches wherein the first spool half and the second spool half (spool 56 halves; [0036]) are adapted to separate from each other and the handle body ([0036]: spool halve are structurally capable of being joined and separated using force) in order to allow release of the proximal portion of the elongate inner member (proximal portion of actuator member 46, Fig 1).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Measamer with similar spool as taught by Measamer for the purpose of securing and facilitating displacing the inner member ([0036]-[0037]).
Regarding claim 18, Dance discloses a handle assembly (1000, Annotated Fig 1) adapted for use with a steerable elongate medical device (catheter body 12, Fig 1), the steerable elongate medical device including an elongate outer member (Outer surface of catheter body 12, Fig 1) and an elongate inner member (guidewire 16, Fig 1) disposed within the elongate outer member (12), the handle assembly (1000, Annotated Fig 1) comprising: a handle body (body of handle 1000, Annotated Fig 1) including a proximal handle (1001, Annotated Fig 1); a spool (guidewire fixation knob 54, Fig 1) slidingly secured to the handle body (body of handle 1000, Annotated Fig 1), the spool (54)adapted to releasable secure the elongate inner member (16) (Col 4, lines 34-43); a collet (rigid threaded nut 28, Fig 1) removably securable to a distal end (1001, Annotated Fig 1) of the handle body (body of handle 1000, Annotated Fig 1), the collet (28) adapted to releasably secure the elongate outer member device (12); wherein steering the steerable elongate medical device (12+16+14) is enabled by moving the spool (54) relative to the handle body (body of handle 1000, Annotated Fig 1).
Dance is silent wherein a first spool half and a second spool half that are adapted to releasably snap together to form a spool slidingly secured to the handle body, the spool adapted to releasable secure the elongate inner member.
Measamer teaches elongate steerable medical device (Fig 1) comprising a first spool half and a second spool half (spool 56 halves; [0036]) that are adapted to releasably snap together to form a spool ([0036]: halves joined by press pins 62) slidingly secured to the handle body (handle assembly 50, Fig 2), the spool (56) adapted to releasable secure the elongate inner member (actuator member 46, Fig 1; [0037]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the spool device of Dance to be split in halves and secure the inner member when joined as taught by Measamer for the purpose of securing and facilitating displacing the inner member ([0036]-[0037])
Claim 13-14 is rejected under 35 U.S.C. 103 as being unpatentable over Dance (US 5117839 A) in view of Kelleher et al. (US 5762069 A) in further view of Bunch et al. (US 20200276414 A1).
Regarding claim 13, Dance discloses the elongate steerable medical device of claim 1, wherein the knob (52) is adapted to rotatably secure the knob (52) to the handle body (1001, Annotated Fig 1) with the proximal portion (1003, Annotated Fig 1) of the elongate inner member (16) extending therethrough.
Dance is silent wherein the knob comprises a first knob half and a second knob half that are adapted to releasably snap together.
Kelleher teaches a medical device (Fig 1) comprising a knob (Wheel 68, Fig 1-2)comprises a first knob half and a second knob half that are adapted to snap together (Col 7, lines 8-11).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the knob of device of Dance to be manufactured in joinable halves as taught by Kelleher to ease the process of putting together the handle components (Col 7, lines 8-11).
Dance/Kelleher are silent wherein the snap is releasable.
Bunch teaches a medical device (Fig 8) comprising a knob (secondary manipulator device 200, Fig 8), wherein the knob comprises a first knob half (281) and a second knob half (282)that are adapted to releasably snap together (Secondary manipulator relies on pins and at least one screw which and is structurally capable of being releasable; [0066]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Kelleher with similar knob snap mechanism as taught by Bunch for the purpose of aligning and releasable secure the halves together ([0066]).
Regarding claim 14, Dance/Kelleher/Bunch discloses the elongate steerable medical device of claim 13. Dance is silent wherein the first knob half and the second knob half are adapted to separate from each other and the handle body in order to allow release of the proximal portion of the elongate inner member from the handle assembly.
Bunch teaches a medical device (Fig 8) comprising a knob (secondary manipulator device 200, Fig 8), wherein the knob comprises a first knob half (mating half 281, Fig 8) and a second knob half (mating half 282, Fig 8) wherein the first knob half (281) and the second knob half (282) are adapted to separate from each other and the handle body (Secondary manipulator relies on pins and at least one screw which and is structurally capable of being releasable; [0066]).
Note: Dance/Kelleher/Bunch as modified is structurally capable of release the proximal portion (1003, Annotated Fig 1; from Dance) of the elongate inner member (16, from Dance) from the handle assembly (1000, Annotated Fig 1) ( the inner member 16 is being held by connections between spool 54+ knob 52+ and fixation device 60; when knob halves are separated, inner member 16 is released).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Kelleher/Bunch with similar knob snap mechanism as taught by Bunch for the purpose of aligning and releasable secure the halves together ([0066]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Dance (US 5117839 A) in view of Measamer (US 20070244512 A1) in further view of Kelleher et al. (US 5762069 A) in view of Bunch et al. (US 20200276414 A1).
Regarding claim 19, Dance/Measamer discloses the handle assembly of claim 18. Dance discloses further comprising a knob (guidewire rotation knob 52, Fig 1) rotatably secured to the handle body (body of handle assembly 1000, Annotated Fig 1) (Col 4, lines 22-33) with the elongate inner member (16) extending therethrough such that rotation of the knob (52)relative to the handle body (body of handle assembly 1000, Annotated Fig 1) causes rotation of the elongate inner member (16).
Dance is silent wherein the knob including a first knob half and a second knob half that are adapted to releasably snap together.
Kelleher teaches a medical device (Fig 1) comprising a knob (Wheel 68, Fig 1-2)comprises a first knob half and a second knob half that are adapted to snap together (Col 7, lines 8-11).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the knob of device of Dance/Measamer to be manufactured in joinable halves as taught by Kelleher to ease the process of putting together the handle components (Col 7, lines 8-11).
Dance/Measamer/Kelleher are silent wherein the snap is releasable.
Bunch teaches a medical device (Fig 8) comprising a knob (secondary manipulator device 200, Fig 8), wherein the knob comprises a first knob half (281) and a second knob half (282)that are adapted to releasably snap together (Secondary manipulator relies on pins and at least one screw which and is structurally capable of being releasable; [0066]).
Therefore, it would be prima facie obvious, before the effective filing date of the present invention, to modify the device of Dance/Measamer/Kelleher with similar knob snap mechanism as taught by Bunch for the purpose of aligning and releasable secure the halves together ([0066]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GUILLERMO G PAZ ESTEVEZ whose telephone number is (703)756-5951. The examiner can normally be reached Monday- Friday 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached on (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GUILLERMO G PAZ ESTEVEZ/ Examiner, Art Unit 3783
/Lauren P Farrar/ Primary Examiner, Art Unit 3783