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 .
Response to Traversal of Restriction
Applicant’s arguments, see Remarks filed November 29, 2025, with respect to claims 1-20 have been fully considered and are persuasive in view of the amendment. The restriction requirement for claims 1-20 has been withdrawn.
In view of the withdrawal of the restriction requirement, Applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Response to Amendment
In response to amendment filed November 29, 2025, claim 1 is amended. No claims are cancelled and no new claims are added.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-4, 10 and 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibe (US 20090281524 A1) in view of Baumann (US 6059739 A; cited by applicant).
With respect to claim 1, Scheibe discloses a bendable sheath (see paragraph 0026, bi-directional sheath assembly #10), comprising
a tube assembly (see paragraph 0027, deflectable sheath #16) and
a handle assembly (see paragraph 0028, handle assembly #14),
the handle assembly comprises a fixing seat (see paragraph 0035 and Fig. 4, knob #66) and a driving member (see paragraph 0036, lead screw #64),
a distal end of the tube assembly is provided with a bendable section (see Fig. 2, distal end of #16 is a bendable section #16A),
a proximal end of the tube assembly is fixedly connected to the driving member (see Fig. 4, #16C is proximal end of sheath #16 and is connected to lead screw #64),
the driving member is rotatably connected to the fixing seat (see Fig. 4 and see paragraph 0036, #64 is rotatably connected to #66),
one of the fixing seat and the driving member comprises an elastic element (see paragraph 0036 and Figs. 9-10, knob #66 comprises a sleeve #68 which is elastic), the other comprises an angle indexing part (see paragraph 0036 and Figs. 9-10, screw #64 comprises threaded portion #64A where screw provides intervals depending on position along screw),
the elastic element is cooperated with the angle indexing part and the relative position of the driving element and the fixed seat is locked in real time (see paragraph and Figs. 4-5 and 7, sleeve #68 is cooperating with threated portion #64A where the position of screw #64 and knob #66 is locked). Scheibe does not specifically disclose a handle assembly which further comprises an adjusting component, and the adjusting component is used to adjust a bending degree of the bendable section so that the distal end of the tube assembly forms a bending angle
Baumann teaches a handle assembly (see Fig. 1, handle #10) which comprises an adjusting component (see col 4 lines 48-55, inner slider member #34 is advanced with respect to handle portion #12 and outer tubular portion is advanced with respect to tension wire #32 which causes deflection of tubular member), and the adjusting component is used to adjust a bending degree of the bendable section so that the distal end of the tube assembly forms a bending angle (see col 1 lines 56-60, control degree of curvature displayed by stylet or guidewire).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scheibe with the teachings of Baumann to have added an adjusting component because it would have resulted in the predictable result of moving or rotating a knob to cause deflection of a distal end of a stylet or guidewire (Baumann: see col 4 lines 48-55) and providing an assembly which is relatively inexpensive and simple to manufacture (Baumann: see col 2 lines 27-37).
With respect to claim 2, all limitations of claim 1 apply in which Scheibe further discloses wherein the angle indexing part comprises a plurality of indexing elements arranged at intervals (see paragraph 0036 and Figs. 9-10, screw #64 comprises threaded portion #64A at multiple locations where screw provides intervals depending on position along screw), when the driving member rotates relative to the fixing seat, the elastic element moves among the plurality of indexing elements (see Fig. 4 and see paragraph 0036, #64 is rotatably connected to #66 and when screw #64 rotates the sleeve #68 moves along the threaded portion #64A).
With respect to claim 3, all limitations of claim 2 apply in which Scheibe further discloses wherein the plurality of indexing elements are arranged at equal intervals or unequal intervals (see paragraph 0036 and Figs. 9-10, screw #64 comprises threaded portion #64A where screw provides equal intervals depending on position along screw).
With respect to claim 4, all limitations of claim 2 apply in which Scheibe further discloses wherein the fixing seat comprises a connecting ring (see paragraph 0035-0036 and Fig. 8, knob #66 has a first friction washer #70), the connecting ring comprises a connecting aperture penetrating through the fixing seat in the axial direction (see Fig. 7-8, #70 connects to knob #66 via the sleeve #68 where the connecting aperture is the hole in the middle of the washer #70), the driving member comprises a connecting cylinder (see paragraph 0034-0038 and Fig. 4, Fig. 7: screw #64 has a lumen #64C on which a support shaft #72 is utilized to attached knob #66 and sleeve #68 onto threaded portion #64A of screw #64), the connecting cylinder is rotatably disposed in the connecting aperture (see Fig. 9, the support shaft #72 is rotatable disposed into #70).
With respect to claim 10, all limitations of claim 4 apply in which Scheibe further discloses
wherein the connecting ring comprises a first side wall facing the driving member (see paragraph 0035-0036 and Fig. 7, washer #70 has a first wall that faces screw #64), the driving member comprises a driving part connected to the connecting cylinder (see Fig. 4), the driving part is provided with a second side wall facing the first side wall around the connecting cylinder (see Fig. 4),
the elastic element is disposed at the first side wall, the plurality of indexing elements are disposed at the second side wall (see Fig. 4); or,
the elastic element is disposed at the second side wall, the plurality of indexing elements are disposed at the first side wall.
With respect to claim 13, all limitations of claim 10 apply in which Scheibe further discloses wherein the elastic element is a convex rib (see paragraph 0035-0036 and 0042 and Fig. 4, knob #66 has sleeve #68 which covers like a rib), […], when the driving member rotates relative to the fixing seat (see Fig. 4), the convex rib is sequentially snapped into the plurality of grooves or the plurality of toothed grooves (see Fig. 4).
Scheibe does not specifically disclose that t the plurality of indexing elements are selected from a plurality of grooves or toothed grooves arranged at intervals.
Baumann teaches a plurality of indexing elements (see Fig. 3 and col 4 lines 14-17, inwardly facing screw threads #38 and outwardly facing screw threads #36) that are a plurality of grooves arranged at intervals (see Fig. 3 and col 4 lines 14-17, threads #36 and threads #38 are arranged at intervals as concave grooves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scheibe with the teachings of Baumann to have a plurality of indexing elements because it would have resulted in the predictable result of rotationally fixing two elements together and allowing them to slid distally relative providing a mechanism for quickly forming a curve in a stylet or guidewire (Baumann: see col 1 lines 65-67-col 2 lines 1-10).
With respect to claim 14, all limitations of claim 4 apply in which Scheibe further discloses wherein the handle assembly further comprises a circlip (see Fig. 4, #60), the outer peripheral wall of the connecting cylinder is provided with a snapping groove (see Fig. 4, #38,#40), the connecting cylinder passes through the connecting aperture and exposes the snapping groove (see Fig. 4), the circlip is snapped into the snapping groove (see Fig. 4).
With respect to claim 15, all limitations of claim 4 apply in which Scheibe further discloses wherein the handle assembly further comprises an inner core (see Fig. 5, inner core is interpreted to be where #16C is running through), a proximal end of the tube assembly is fixedly connected to the inner core (see Fig. 4-5, proximal end of #16 is attached to inner core where #16C is pointing), the driving member is fixedly connected to the inner core (see Fig. 4, screw #64 is connected to inner core where #16C is pointing).
With respect to claim 16, all limitations of claim 15 apply in which Scheibe further discloses wherein the proximal end of the inner core is further provided with a plurality of locking slots (see Fig. 4, inner core has locking slots #36,#38,#40), the inner peripheral wall of the connecting cylinder is provided with a plurality of locking ribs (see Fig. 4), the plurality of locking ribs and the plurality of locking slots are corresponding to each other and connected with each other (see Fig. 4).
With respect to claim 17, Scheibe discloses a bendable sheath (see paragraph 0026, bi-directional sheath assembly #10), comprising a tube assembly (see paragraph 0027, deflectable sheath #16) and a handle assembly (see paragraph 0028, handle assembly #14), a distal end of the tube assembly is provided with a bendable section (see Fig. 2, distal end of #16 is a bendable section #16A), the handle assembly comprises:
a fixing seat (see paragraph 0035 and Fig. 4, knob #66), the fixing seat is rotatably connected to the tube assembly (see paragraph 0035 and Fig. 4, knob #66 is rotatably connected to sheath #16);
a driving member (see paragraph 0036, lead screw #64), the driving member is rotatably connected to the fixing seat (see Fig. 4 and see paragraph 0036, #64 is rotatably connected to #66), the driving member is fixedly connected to a proximal end of the tube assembly and drives the tube assembly to rotate relative to the fixing seat (see Fig. 4 and see paragraph 0036, #64 is rotatably connected to #66 and fixed to proximal end of sheath #16 and drives sheath #16 to rotate relative to knob #66); […].
Scheibe does not specifically disclose an adjusting component, the adjusting component is rotatable relative to the fixing seat, the adjusting component is connected to the bendable section and used to adjust the bending degree of the bendable section.
Baumann teaches a handle assembly (see Fig. 1, handle #10) which comprises an adjusting component (see col 4 lines 48-55, inner slider member #34 is advanced with respect to handle portion #12 and outer tubular portion is advanced with respect to tension wire #32 which causes deflection of tubular member), the adjusting component is rotatable relative to the fixing seat (see col 4 lines 48-55, rotation of knob with respect to inner slider member #31) the adjusting component is connected to the bendable section and used to adjust the bending degree of the bendable section (see col 1 lines 56-60, control degree of curvature displayed by stylet or guidewire).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scheibe with the teachings of Baumann to have added an adjusting component because it would have resulted in the predictable result of moving or rotating a knob as part of a handle to cause deflection of a distal end of a stylet or guidewire (Baumann: see col 4 lines 48-55) and providing an assembly which is relatively inexpensive and simple to manufacture (Baumann: see col 2 lines 27-37).
With respect to claim 18, all limitations of claim 17 apply in which Scheibe and Baumann further teaches wherein the driving member (Scheibe: see paragraph 0036, lead screw #64) and the adjusting component (Baumann: see col 4 lines 48-55, inner slider member #34) are respectively disposed at the both sides of the fixing seat (Scheibe: see paragraph 0035 and Fig. 4, knob #66 would have a screw #64 on one side and an adjustment component on another side).
With respect to claim 19, all limitations of claim 17 apply in which Baumann further teaches wherein the adjusting component comprises a sliding member (Baumann: see col 4 lines 48-55, inner slider member #34) and a adjusting member sleeved at the sliding member (Baumann: see col 4 lines 48-55, inner slider member #34), the sliding member is connected to the bendable section (Baumann: see col 4 lines 48-55 and Fig. 3, inner slider member #34 connects to deflectable stylet #16), the adjusting member drives the sliding member to move to adjust the bending degree of the bendable section (see col 4 lines 48-55, inner slider member #34 is advanced with respect to handle portion #12 and outer tubular portion is advanced with respect to tension wire #32 which causes deflection of tubular member).
With respect to claim 20, all limitations of claim 17 apply in which Scheibe further discloses wherein one of the fixing seat and the driving member comprises an elastic element (see paragraph 0036 and Figs. 9-10, knob #68 comprises a sleeve #68 which is elastic), the other comprises an angle indexing part (see paragraph 0036 and Figs. 9-10, screw #64 comprises threaded portion #64A where screw provides intervals depending on position along screw) and the relative position of the driving element and the fixed seat is locked in real time (see paragraph and Figs. 4-5 and 7, sleeve #68 is cooperating with threated portion #64A where the position of screw #64 and knob #66 is locked).
Claims 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibe in view of Baumann as applied to claim 4 above, and further in view of Eversull (US 9950142 B2).
With respect to claim 5, all limitations of claim 4 apply in which Scheibe further discloses wherein the driving member comprises a driving cylinder coaxial with the connecting cylinder (see paragraph 0036-0038, lead screw #64 has washer #76), an annular groove is formed between the driving cylinder and the connecting cylinder (see Fig. 9, a circular groove is formed between shaft #72 and washer #76), the connecting ring is rotatably accommodated in the annular groove (see Fig. 9, #70 is accommodated into groove formed between #76 and #72).
Scheibe and Baumann do not specifically teach the elastic element is disposed at the outer peripheral wall of the connecting ring, the plurality of indexing elements are disposed at the inner peripheral wall of the driving cylinder or that the elastic element is disposed at the inner peripheral wall of the driving cylinder, the plurality of indexing elements are disposed at the outer peripheral wall of the connecting ring.
Eversull teaches an elastic element (see Fig. 1b, rotatable knob #34a) that is disposed on an outer peripheral wall of a connecting ring (see Fig. 1b, #34a is on the outside of #30) and Eversull further teaches a plurality of indexing elements (see Fig. 1b, one or more threads #34c) that are disposed at the inner peripheral wall of the connecting ring (see Fig. 1, #34b is on the inside of #30)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scheibe and Baumann with the teachings of Eversull to have disposes elements on two different sides because it would have resulted in the predictable result of allowing a desired amount of rotation between two elements when moving a stylet (see col 8 lines 27-56).
With respect to claim 6, all limitations of claim 5 apply in which Scheibe further discloses wherein the fixing seat further comprises a fixing ring disposed at one end of the connecting ring (see paragraph 0035-0036 and Fig. 5-7, knob #66 has oval shaped protrusions #66A at one end of washer #70), the fixing seat form a circular stepped structure (see Fig. 7, knob #66 is circular), the fixing ring is coaxial with the connecting ring, the fixing ring is axially communicated to the connecting ring (see Fig. 7, knob #66 is coaxial with washer #70).
With respect to claim 7, all limitations of claim 5 apply in which Scheibe further discloses wherein the elastic element is selected from a spring plunger or an elastic protrusion (see paragraph 0036 and Figs. 9-10, knob #68 comprises a sleeve #68 which is elastic), […], when the driving member rotates relative to the fixing seat, the spring plunger or the elastic protrusion is sequentially snapped into the plurality of concave grooves (see Fig. 4).
Scheibe does not specifically disclose that the plurality of indexing elements are a plurality of concave grooves arranged at intervals.
Baumann teaches a plurality of indexing elements (see Fig. 3 and col 4 lines 14-17, inwardly facing screw threads #38 and outwardly facing screw threads #36) that are a plurality of concave grooves arranged at intervals (see Fig. 3 and col 4 lines 14-17, threads #36 and threads #38 are arranged at intervals as concave grooves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scheibe with the teachings of Baumann to have a plurality of indexing elements because it would have resulted in the predictable result of rotationally fixing two elements together and allowing them to slid distally relative providing a mechanism for quickly forming a curve in a stylet or guidewire (Baumann: see col 1 lines 65-67-col 2 lines 1-10).
With respect to claim 8, all limitations of claim 7 apply in which Scheibe further discloses wherein the outer peripheral wall of the connecting ring or the inner peripheral wall of the driving cylinder is provided with an installation aperture along the radial direction (see paragraph 0035-0036 and 0042 and Fig. 4, knob #66 has sleeve #68 with internal threads #68A that has a aperture where a wire is going through it), the elastic element is the spring plunger disposed in the installation aperture (claim 7 recites spring plunger or elastic protrusion where elastic protrusion was examined).
With respect to claim 9, all limitations of claim 5 apply in which Scheibe further discloses wherein the elastic element is a convex rib (see paragraph 0035-0036 and 0042 and Fig. 4, knob #66 has sleeve #68 which covers like a rib), […], when the driving member rotates relative to the fixing seat (see Fig. 4), the convex rib is sequentially snapped into the plurality of grooves or the plurality of toothed grooves (see Fig. 4).
Scheibe does not specifically disclose that the plurality of indexing elements are selected from a plurality of grooves or toothed grooves arranged at intervals.
Baumann teaches a plurality of indexing elements (see Fig. 3 and col 4 lines 14-17, inwardly facing screw threads #38 and outwardly facing screw threads #36) that are a plurality of grooves arranged at intervals (see Fig. 3 and col 4 lines 14-17, threads #36 and threads #38 are arranged at intervals as grooves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scheibe with the teachings of Baumann to have a plurality of indexing elements because it would have resulted in the predictable result of rotationally fixing two elements together and allowing them to slid distally relative providing a mechanism for quickly forming a curve in a stylet or guidewire (Baumann: see col 1 lines 65-67-col 2 lines 1-10).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Scheibe in view of Baumann as applied to claim 10 above, and further in view of Kuehn (US 6743239 B1).
With respect to claim 11, all limitations of claim 10 apply in which Scheibe further discloses when the driving member rotates relative to the fixing seat, the spring plunger or the elastic protrusion is sequentially snapped into the plurality of concave grooves (see Fig. 4).
Scheibe does not specifically disclose that the plurality of indexing elements are a plurality of concave grooves arranged at intervals. Scheibe also does not specifically disclose wherein the elastic element is selected from a spring plunger or an elastic protrusion.
Baumann teaches a plurality of indexing elements (see Fig. 3 and col 4 lines 14-17, inwardly facing screw threads #38 and outwardly facing screw threads #36) that are a plurality of concave grooves arranged at intervals (see Fig. 3 and col 4 lines 14-17, threads #36 and threads #38 are arranged at intervals as concave grooves).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Scheibe with the teachings of Baumann to have a plurality of indexing elements because it would have resulted in the predictable result of rotationally fixing two elements together and allowing them to slid distally relative providing a mechanism for quickly forming a curve in a stylet or guidewire (Baumann: see col 1 lines 65-67-col 2 lines 1-10).
Scheibe and Baumann do not specifically teach wherein the elastic element is selected from a spring plunger or an elastic protrusion.
Kuehn teaches an elastic element selected from a spring plunger (see Fig. 29 and col 6 lines 32-58, shaft #556 can be pulled to draw spring #540 towards plunger #546 where arm #550 moves).
It would have been obvious to one of ordinary skill in the art before the effective filings date of the claimed invention to have modified Scheibe and Baumann with the teachings of Kuehn to have utilized a spring plunger because it would have resulted in the predictable result of allowing an elastic element to extend and fold when device is in use (Kuehn: see col 6 lines 32-58).
With respect to claim 12, all limitations of claim 11 apply in which Scheibe in view of Baumann and Kuehn further teaches wherein the first side wall or the second side wall is provided with an installation aperture in the axial direction (Scheibe: see paragraph 0035-0036 and 0042 and Fig. 4, knob #66 has sleeve #68 with internal threads #68A that has a aperture where wire is going through it), the elastic element is the spring plunger disposed in the installation aperture (Kuehn: see Fig. 29 and col 6 lines 32-58, shaft #556 can be pulled to draw spring #540 towards plunger #546 where arm #550 moves).
It would have been obvious to one of ordinary skill in the art before the effective filings date of the claimed invention to have modified Scheibe and Baumann with the teachings of Kuehn to have utilized a spring plunger disposed in an aperture because it would have resulted in the predictable result of allowing an elastic element to extend and fold when device is in use (Kuehn: see col 6 lines 32-58).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791