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 Amendment
The amendment filed 07/03/2026 has been entered. Claims 1-20 remain pending in the application, with claim 20 having been withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejections previously set forth in the Non-Final Office Action mailed 04/07/2026.
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 1 is objected to because of the following informalities:
“the tubular shaft being including a plurality of axially...” corrected to:
“the tubular shaft member including a plurality of axially…”
Claim 14 is objected to because of the following informalities:
“extend from the distal end of the tubular shaft toward” corrected to:
“extend from the distal end of the tubular shaft member toward”
Appropriate correction is required.
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.
Claims 1, 3-8, and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Itou (US20110224650) in view of Dick (US20090018393) and O’Connor (US6352531).
Regarding claim 1, Itou teaches an image core drive shaft (42) that is to be used in an image diagnosis catheter and that is connectable to an external device (7, 71) configured to rotationally drive the image core drive shaft (42) (Figs. 1-2, 4, & 11, [0033-0034], [0038], [0045], [0046-0047], [0088-0089], “The ultra-sound catheter 1 described above is connected to an external drive apparatus 7 shown in FIG. 11 and is driven by this external drive apparatus 7”, [0092], “…by transmitting a rotational motion of the motor in the scanner device 71 to the drive shaft 42”), the image core drive shaft (42) comprising:
a coil shaft (42) having a distal end configured to be fixed to a proximal end of a housing (412) that accommodates a signal transmitter and receiver (411), the coil shaft (42) possessing a proximal end and a distal end, the coil shaft (42) including at least one wire that is wound into a coil (Figs. 1-2 & 4-5, [0038], [0040]).
However, Itou fails to teach a tubular shaft member fixed to the proximal end of the coil shaft so that the coil shaft and the shaft member rotate together when the image core drive shaft is rotated, the tubular shaft member having higher torsional stiffness than torsional stiffness of the coil shaft; and the tubular shaft member having a distal end and a proximal end that are axially spaced apart from one another.
In an analogous catheter field of endeavor, Dick teaches such a feature. Dick teaches a catheter (10) including a rotary drive shaft (40) having an optical train (30), and optical fiber (50), thus teaching an image core drive shaft (Fig. 1, [0028-0029]). Dick teaches wherein the rotary drive shaft (40) comprises a hypotube metal drive shaft (400) joined with a stranded hollow core shaft (500) (Figs. 9-11, [0050]). Dick teaches wherein the stranded hollow core shaft (500) comprises helically wound metal wires (520), thus comprising a coil shaft ([0051], [0053], “coiled hollow core shaft”). Dick teaches a distal end of the hypotube metal shaft (400) is joined onto a proximal end of the hollow core shaft (500) via coaxial engagement, thus teaching wherein the hypotube metal shaft (400) comprises a tubular shaft member fixed to a proximal end of a coil shaft (Fig. 10b, [0054]). Moreover, figure 10b shows wherein the tubular shaft member (400) includes a spaced apart distal end and proximal end (Fig. 10b). Dick teaches wherein the coaxial fitting ensures a 1:1 rotation of the hypotube metal shaft (400) and the stranded hollow core shaft (500) ([0054]). Dick therefore teaches a tubular shaft member (hypotube 400) fixed to a proximal end of a coil shaft (hollow core shaft 500) so that the coil shaft and the shaft member rotate together when the image core drive shaft is rotated. Dick further teaches wherein the hypotube metal drive shaft (400) is a solid metal wall which has increased torsional rigidity (stiffness) and reduces or eliminates the possibility of the coiled hollow core shaft from unraveling or dissociating under torsional forces applied ([0053]). Moreover, Dick teaches wherein the diameters of the core shaft and hypotube metal tube are substantially the same ([0032], “The coaxial fitting of the hypotube metal over the stranded hollow core shaft may be accomplished by allowing the OD of the stranded hollow core shaft to vary from the ID of the hypotube metal tube by about 0.001 to 0.009 inches”). Dick also teaches wherein both the core shaft (500) and hypotube shaft (400) may comprise nitinol ([0050-0051]). At matched diameter and material, the closed-wall solid tube hypotube shaft (tubular shaft member) necessarily has higher torsional stiffness than the helically wound core shaft (coil shaft). Twisting of a coil turns applied torque into bending and unbending of the wire rather than pure cross-sectional twist. Reference “Symmetry Laser”, attached to the Office Action, evidences that a tubular shaft (i.e. hypotube shaft 500) has higher torsional stiffness than a coil shaft (i.e. core shaft 500) by disclosing “Inherent helical structure: A coil’s helical geometry means that applying torque simply tightens or loosens the coil rather than efficiently transmitting rotation. The effective torsional stiffness is orders of magnitude lower than a tubular structure”. Moreover, where the prior art structure is substantially identical, a claimed property (i.e. the tubular shaft member having higher torsional stiffness than torsional stiffness of the coil shaft) is presumed inherent and applicant bears burden of showing otherwise. See In Re Best, 562 F.2d 1252, 1255; In re Spada, 911 F.2d 705, 709; MPEP § 2112(IV), 2112.01(I)-(II).
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 the invention of Itou to have the image core drive shaft comprise a coil shaft joined to a solid metal wall hypotube as taught by Dick (Fig. 10b, [0028-0029], [0032], [0050-0051], [0053-0054]). The hypotube joined to the coil shaft allows for increased torsional rigidity, increases column strength or axial rigidity to improve push-ability, reduces or eliminates possibility of the coil shaft unraveling or dissociating under torsional forces applied, and reduces NURD, wherein NURD is a known failure mode for rotational imaging as recognized by Dick ([0003], [0053]). Modifying Itou to include a solid wall metal hypotube attached to the coil shaft of Dick would predictably result wherein the tubular shaft member (metal hypotube 400) has higher torsional stiffness than that of the coil shaft (core shaft 500) since a coil’s structural geometry has an effective torsional stiffness orders of magnitude lower than a tubular structure as evidenced by Symmetry Laser. Where the prior art structure is substantially identical, a claimed property (i.e. the tubular shaft member having higher torsional stiffness than torsional stiffness of the coil shaft) is presumed inherent and applicant bears burden of showing otherwise. See In Re Best, 562 F.2d 1252, 1255; In re Spada, 911 F.2d 705, 709; MPEP § 2112(IV), 2112.01(I)-(II).
However, the modified combination noted above fails to teach the tubular shaft being including a plurality of axially spaced apart slits.
In an analogous catheter field of endeavor, Dick and O’Connor teaches such a feature. Dick teaches wherein slots, holes, or other aperture shape formations may be formed by means of cutting or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft (400) while retaining substantial torsional rigidity ([0055]). Dick thus provides motivation and reason to include a plurality of slits in the tubular shaft member.
O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein a shaft (42) may include notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A, reproduced below, the plurality of notches or slits (44, 46) are axially spaced apart. While Dick above provides reason to include slits in the tubular shaft member, O’Connor provides the slit geometry for providing the flexibility.
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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 the invention of Itou to have the tubular hypotube shaft member include axially spaced apart slits as taught by Dick ([0055]) and by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by Dick and O’Connor may predictably cause a specific area in the shaft to have additional desired flexibility as recognized by Dick ([0055]) and O’Connor (Column 5 lines 60-67).
Regarding claim 3, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 1
However, Itou fails to teach wherein an axial length of the tubular shaft member is 200 mm or more and 1750 mm or less.
While Itou fails to teach such a feature, it would have still been obvious to one of ordinary skill in the art, before the effective filing date of the invention, to have modified the invention of Itou to have the axial length of the tubular shaft member be 200 mm or more and 1750 mm or less. Itou in view of Dick teaches wherein the tubular shaft member may comprise a hypotube metal drive shaft. Dick teaches additional length (longer sections) of the hypotube metal shaft may be employed to achieve a greater reduction of nonuniform rotational distortion (“NURD”) ([0055]). Dick further teaches wherein the length of the hypotube metal shaft should not extend too far distally as it would interfere with the flexibility of the catheter and prevent it from navigating anatomical passageways ([0055]). Dick therefore recognizes tubular shaft member length as a result-effective variable which affects NURD reduction and flexibility. It would have been obvious to a person of ordinary skill in the art before the effective filing date to determine a workable axial length of the tubular shaft member, including a length within the recited 200 mm to 1750 mm, through routine optimization of the tradeoff Dick identifies. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); MPEP § 2144.05 (II).
Regarding claim 4, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 1.
Itou further teaches the at least one wire that is wound into the coil (42) having an outer periphery that is exposed (Fig. 2, wherein figure 2 show wherein the coil 42 has an outer periphery that is exposed).
However, Itou fails to teach wherein the plurality of slits in the tubular shaft member pass through the tubular shaft member.
In an analogous catheter field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Conor teaches wherein the fiber shaft (30) is surrounded by a reinforcing tube (38) (i.e. tubular shaft member) which includes a plurality of helically arranged apertures (40) formed as slits (Fig. 3A, Column 5 lines 17-35). As shown in figure 3A, reproduced below, the plurality of slits (40) in the tubular shaft member pass through the tubular shaft member, exposing the optical fiber (32) underneath.
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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 the invention of Itou to have the plurality of slits pass through the tubular shaft member as taught by O’Connor (Fig. 3A, Column 5 lines 17-35). Having the plurality of slits pass through the tube predictably allows for greater flexibility than incompletely passing through.
However, the modified combination noted above fails to expressly teach the tubular shaft member having an outer surface that is exposed.
In an analogous catheter field of endeavor, Dick teaches such a feature. Dick teaches a catheter (10) including a rotary drive shaft (40) having an optical train (30), and optical fiber (50), thus teaching an image core drive shaft (Fig. 1, [0028-0029]). Dick teaches wherein the rotary drive shaft (40) comprises a hypotube metal drive shaft (400) joined with a stranded hollow core shaft (500) (Figs. 9-11, [0050]). Dick teaches wherein the stranded hollow core shaft (500) comprises helically wound metal wires (520), thus comprising a coil shaft ([0051], [0053], “coiled hollow core shaft”). Dick teaches a distal end of the hypotube metal shaft (400) is joined onto a proximal end of the hollow core shaft (500) via coaxial engagement, thus teaching wherein the hypotube metal shaft (400) comprises a tubular shaft member fixed to a proximal end of a coil shaft (Fig. 10b, [0054]). As shown by figure 10b, the tubular shaft member (400) has an exposed outer surface (Fig. 10b). Dick further teaches wherein the tubular shaft member (400) improves frictional interface by replacing an interrupted or more concentrated load transference between individual strands and the monolithic outer sheath with a continuous and more distributed load across a solid-walled hypotube metal shaft ([0053]).
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 the invention of Itou to similarly have the tubular shaft member have an exposed outer surface like the coil shaft as taught by Dick (Fig. 10b, [0053]). The exposed surface may may improve frictional interface by receiving load from the sheath and provide continuous load distribution across the tubular shaft member as recognized by Dick ([0053]).
Regarding claim 5, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 4.
However, Itou fails to teach wherein each of the plurality of slits has a non-spiral shape.
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A, reproduced below, the notches or slits (44, 46) have a non-spiral shape.
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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 the invention of Itou to have the notch be a non-spiral shape or pattern as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67). Moreover, O’Connor similarly teaches wherein the notch may be spiral shaped (Fig. 3A), therefore showing wherein multiple patterns or solutions may be implemented to create a catheter portion with desired flexibility, torqueability, and pushability.
Regarding claim 6, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 4.
However, Itou fails to teach wherein the plurality of slits includes a plurality of pairs of slits, the pairs of slits being axially spaced apart along a length of the tubular shaft member, each of the slits extending along a circumferential direction
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A, reproduced below, the notch includes a plurality of pairs of slits (44, 46), each slit of a pair being radially opposite one another, the pairs of slits being axially spaced apart along a length of the tube, and each of the slits extending along a circumferential direction (slits 46 are shown extending along a circumferential direction, implying slits 44 is similar).
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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 the invention of Itou to have the notch include a plurality of pairs of slits which are alternating laterally as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67).
Regarding claim 7, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 4.
However, Itou fails to teach wherein each of the plurality of slits extends along less than an entirety of a circumferential extent of the tubular shaft member.
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A and especially slits 46 reproduced below, the slits (44, 46) extend along less than the entirety of the circumference of the shaft comprising a tubular member.
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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 the invention of Itou to have the notch include a plurality of pairs of slits which are alternating laterally as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67).
Regarding claim 8, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 1.
However, Itou fails to teach wherein the tubular shaft member includes a longitudinally extending main portion in which the plurality of slits each having a width and arranged in a circumferential direction of the main portion each having a width and arranged in a circumferential direction of the main portion are disposed in a pattern, the slits being axially spaced apart at a pitch along a longitudinal extent of the main portion.
In an analogous catheter field of endeavor, Dick and Itou teaches such a feature. Dick teaches wherein slots, holes, or other aperture shape formations may be formed by means of cutting or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft (400) while retaining substantial torsional rigidity ([0055]). Dick thus provides motivation and reason to include a plurality of slits in the tubular shaft member for increased flexibility.
Itou teaches wherein an intermediate tube (13) may include a longitudinally extending main portion (17) in which a plurality of slits (14) each having a width and arranged in a circumferential direction of the main portion (17) are disposed in a pattern (spiral), the slits (14) being axially spaced apart at a pitch along a longitudinal extend of the main portion (17) (Figs. 6 & 8, [0015], [0061], [0068], “The slit pitch of the second intermediate slit portion 17 is preferably around 3 mm to 6 mm”, [0099]).
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 the invention of Itou to similarly include a main portion of a plurality of slits having a gradient/graded slit density axially spaced apart at a pitch as taught by Dick ([0055]) and Itou (Figs. 6 & 8, [0015], [0061], [0068], [0099]). Having a main portion (in which slit density is lowest) and graded slit density may provide for greater flexibility at a distal portion and some rigidity on the proximal side, allowing for relatively easier insertion of the catheter in a living body as recognized by Itou ([0015], [0099]).
Regarding claim 12, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 8.
However, Itou fails to teach wherein the pattern of slits in the longitudinally extending main portion is a pattern in which the slits are arranged in pairs, the pairs of slits being arranged side by side at the pitch in the axial direction while being circumferentially shifted by a predetermined angle, the slits in each pair facing each other in a radial direction.
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A reproduced below, the pairs of slits (44, 46) are arranged side by side at the pitch in an axial direction while being circumferentially shifted by a predetermined angle (90°), and the slits in each pair (44, 46; see slits 44) facing each other in the radial direction.
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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 the invention of Itou to have the pattern of slits be arranged alternating laterally as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67). O’Connor similarly teaches wherein the configuration or arrangement may include variable width and depth of the slits (44, 46) (Column 5 lines 65-67), thereby including main and weakened portions. Itou modified by the teachings of O’Connor would thus predictably result wherein the spiral pattern including the main portion taught by Itou is instead alternating laterally arranged slits (44, 46) like taught by O’Connor (Fig. 4A, Column 5 lines 60-67).
Regarding claim 13, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 1.
Itou further teaches an image diagnosis catheter (1) (Fig. 1, [0033-0034]) comprising:
an imaging core (4) comprised of an image core drive shaft (42) according to Claim 1 (Figs. 1-2 & 6, [0033-0034], [0038], [0055], Itou in view of Dick and O’Connor above teaches the imaging core according to claim 1); and
a sheath (2) in which the imaging core (4) is positioned (Figs. 1-2, [0034], [0038]).
Regarding claim 14, Itou teaches an image diagnosis catheter (1) (Fig. 1, [0033-0034]) comprising:
an imaging core (4) and a tubular sheath (2) in which the imaging core (4) is positioned (Figs. 1-2, [0034], [0038]), the imaging core (4) comprising:
a drive shaft (42) connectable to an external device (7, 71, 72) configured to rotationally drive and axially move the drive shaft, a housing (412), and a signal transmitter and receiver (411) positioned in the housing (412) and connected to a signal line (54) extending inside the drive shaft (42) (Figs. 1-2, 4, & 11, [0038], [0040], [0055], [0088-0089], “The ultra-sound catheter 1 described above is connected to an external drive apparatus 7 shown in FIG. 11 and is driven by this external drive apparatus 7”, “an axial direction moving device 72 which grabs the scanner device 71 and which causes the axial direction movement depending on the motor and the like”, [0092], “…by transmitting a rotational motion of the motor in the scanner device 71 to the drive shaft 42”, [0097]),
the drive shaft (42) comprising: a tubular coil shaft (42) (Figs. 2 & 6, [0040], [0055]);
the tubular coil shaft (42) possessing a distal end to which the housing (412) is connected so that rotation and axial movement of the drive shaft (42) results in rotation and axial movement of the housing (412) and the signal transmitter and receiver (411), the coil shaft (42) including at least one wire that is wound into a coil (Figs. 1-2 & 4-6, [0038], [0042], [0053], [0055], [0061], wherein figures 1 & 5 shows the shaft member 13 being fixed to a proximal end of the coil shaft 42 at connector 33, [0088-0089], [0092], “…by transmitting a rotational motion of the motor in the scanner device 71 to the drive shaft 42 and by rotating the housing 412 fixed at the distal end of the drive shaft 42. By pulling the whole ultra-sound catheter 1 toward the hand-side and by causing the ultrasonic transducer 411 to move in the longitudinal direction, it is possible to obtain a cross-sectional image of 360.degree”, [0097], “the axial direction moving device 72 is operated, the ultrasonic transducer 411 moves toward the axial direction”).
However, Itou fails to teach the drive shaft comprising: a tubular shaft member, the tubular shaft member possessing a distal end and a proximal end, the distal end of the tubular shaft member being connected to the tubular coil shaft so that the tubular coil shaft and the tubular shaft member rotate and axially move together when the drive shaft is rotated and axially moved, the tubular shaft member including a plurality of slits, and a main portion of the tubular shaft member at which are located the plurality of slits having a higher torsional stiffness than a torsional stiffness of the coil shaft.
In an analogous catheter field of endeavor, Dick teaches such a feature. Dick teaches a catheter (10) including a rotary drive shaft (40) having an optical train (30), and optical fiber (50), thus teaching an image core drive shaft (Fig. 1, [0028-0029]). Dick teaches wherein the rotary drive shaft (40) comprises a hypotube metal drive shaft (400) joined with a stranded hollow core shaft (500) (Figs. 9-11, [0050]). Dick teaches wherein the stranded hollow core shaft (500) comprises helically wound metal wires (520), thus comprising a coil shaft ([0051], [0053], “coiled hollow core shaft”). Dick teaches a distal end of the hypotube metal shaft (400) is joined onto a proximal end of the hollow core shaft (500) via coaxial engagement, thus teaching wherein the hypotube metal shaft (400) comprises a tubular shaft member fixed to a proximal end of a coil shaft (Fig. 10b, [0054]). Moreover, figure 10b shows wherein the tubular shaft member (400) possesses a distal end and proximal end (Fig. 10b). Dick teaches wherein the coaxial fitting ensures a 1:1 rotation of the hypotube metal shaft (400) and the stranded hollow core shaft (500) ([0054]). Dick therefore teaches a tubular shaft member (hypotube 400) fixed to a proximal end of a coil shaft (hollow core shaft 500) so that the coil shaft and the shaft member rotate together when the drive shaft is rotated and axially moved. Dick further teaches wherein the hypotube metal drive shaft (400) is a solid metal wall which has increased torsional rigidity (stiffness) and reduces or eliminates the possibility of the coiled hollow core shaft from unraveling or dissociating under torsional forces applied ([0053]). Moreover, Dick teaches wherein the diameters of the core shaft and hypotube metal tube are substantially the same ([0032], “The coaxial fitting of the hypotube metal over the stranded hollow core shaft may be accomplished by allowing the OD of the stranded hollow core shaft to vary from the ID of the hypotube metal tube by about 0.001 to 0.009 inches”). Dick also teaches wherein both the core shaft (500) and hypotube shaft (400) may comprise nitinol ([0050-0051]). In addition, Dick teaches wherein the hypotube (500) may include a plurality of slits ([0055], “Alternatively, slots, holes or other aperture shape formations may be formed by means of cutting, etching, ablating or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft 400 while retaining substantial torsional rigidity”). Dick therefore teaches the tubular shaft member including a plurality of slits. At matched diameter and material, the slitted solid tube hypotube shaft (tubular shaft member) necessarily has higher torsional stiffness than a helically wound core shaft (coil shaft). Twisting of a coil turns applied torque into bending and unbending of the wire rather than pure cross-sectional twist. Reference “Symmetry Laser”, attached to the Office Action, evidences that a tubular shaft (i.e. hypotube shaft 500) has higher torsional stiffness than a coil shaft (i.e. core shaft 500) by disclosing “Inherent helical structure: A coil’s helical geometry means that applying torque simply tightens or loosens the coil rather than efficiently transmitting rotation. The effective torsional stiffness is orders of magnitude lower than a tubular structure”. The difference of a metal hypotube having a plurality of slits is negligible compared to a helically wound wire. Moreover, where the prior art structure is substantially identical, a claimed property (i.e. the tubular shaft member having higher torsional stiffness than torsional stiffness of the coil shaft) is presumed inherent and applicant bears burden of showing otherwise. See In Re Best, 562 F.2d 1252, 1255; In re Spada, 911 F.2d 705, 709; MPEP § 2112(IV), 2112.01(I)-(II).
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 the invention of Itou to have the image core drive shaft comprise a coil shaft joined to a solid metal wall hypotube as taught by Dick (Fig. 10b, [0028-0029], [0032], [0050-0051], [0053-0054]). The hypotube joined to the coil shaft allows for increased torsional rigidity, increases column strength or axial rigidity to improve push-ability, reduces or eliminates possibility of the coil shaft unraveling or dissociating under torsional forces applied, and reduces NURD, wherein NURD is a known failure mode for rotational imaging as recognized by Dick ([0003], [0053]). Modifying Itou to include a solid wall metal hypotube attached to the coil shaft of Dick would predictably result wherein the tubular shaft member (metal hypotube 400) has higher torsional stiffness than that of the coil shaft (core shaft 500) since a coil’s structural geometry has an effective torsional stiffness orders of magnitude lower than a tubular structure as evidenced by Symmetry Laser. Where the prior art structure is substantially identical, a claimed property (i.e. the tubular shaft member having higher torsional stiffness than torsional stiffness of the coil shaft) is presumed inherent and applicant bears burden of showing otherwise. See In Re Best, 562 F.2d 1252, 1255; In re Spada, 911 F.2d 705, 709; MPEP § 2112(IV), 2112.01(I)-(II).
However, the modified combination noted above fails to teach the tubular shaft member being comprised of a main portion that extends from the distal end of the tubular shaft toward the proximal end of the tubular shaft member.
In an analogous catheter field of endeavor, Dick and Itou teaches such a feature. Dick teaches wherein slots, holes, or other aperture shape formations may be formed by means of cutting or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft (400) while retaining substantial torsional rigidity ([0055]). Dick thus provides motivation and reason to include a plurality of slits in the tubular shaft member for increased flexibility.
Itou teaches an intermediate tube (13) being comprised of a main portion (17) that extends from a distal end of the intermediate tube toward a proximal end of the intermediate tube (13), the intermediate tube (13) including a plurality of slits (14) (Figs. 6-9, [0061]).
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 the invention of Itou to have the tubular shaft member include a main portion which extends from a proximal to distal direction with a plurality of slits as taught by Dick ([0055]) and Itou (Figs. 6-9, [0061]). The graded slits including a main portion and weakened portion of axially spaced apart slits may produce desired flexibility at certain locations of the shaft which may improve steerability and maneuverability as recognized by Itou (Figs. 6-9, [0015], [0099]).
However, the combination noted above fails to teach wherein the plurality of slits are axially spaced apart from one another.
In an analogous catheter field of endeavor, Dick and O’Connor teaches such a feature. Dick teaches wherein slots, holes, or other aperture shape formations may be formed by means of cutting or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft (400) while retaining substantial torsional rigidity ([0055]). Dick thus provides motivation and reason to include a plurality of slits in the tubular shaft member.
O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein a shaft (42) may include notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A, reproduced below, the plurality of notches or slits (44, 46) are axially spaced apart. While Dick above provides reason to include slits in the tubular shaft member, O’Connor provides the slit geometry for providing the flexibility.
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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 the invention of Itou to have the tubular hypotube shaft member include axially spaced apart slits as taught by Dick ([0055]) and by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by Dick and O’Connor may predictably cause a specific area in the shaft to have additional desired flexibility as recognized by Dick ([0055]) and O’Connor (Column 5 lines 60-67).
Regarding claim 15, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 14.
However, Itou fails to teach wherein the slits are arranged in pairs, the slits of each pair facing each other in a radial direction.
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A reproduced below, the slits (44, 46) are arranged in pairs and the slits of each pair (see 44) face each other in a radial direction.
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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 the invention of Itou to have the pattern of slits be arranged alternating laterally as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67).
Regarding claim 16, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 14.
Itou further teaches wherein the main portion (17) of the tubular shaft member (13) possesses a circumference (Figs. 6-7, [0062]).
However, Itou fails to teach each of the slits extending along only a portion of the circumference of the main portion of the tubular shaft member.
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A and especially slits 46 reproduced below, the slits (44, 46) extend along only a portion of the circumference of the shaft comprising a tubular member.
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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 the invention of Itou to have the plurality of pairs of slits alternate laterally and extend only a portion of the circumference as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67).
Regarding claim 17, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 14.
However, Itou fails to teach wherein axially adjacent slits are offset from each other in a circumferential direction of the main portion of the tubular shaft member.
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A reproduced below, the axially adjacent slits 44 and 46 are offset from each other in a circumferential direction.
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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 the invention of Itou have the pattern of slits be arranged alternating laterally as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67).
Regarding claim 18, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 17.
However, Itou fails to teach wherein the slits are arranged in pairs so that two slits forming each pair are positioned at a common axial position along the main portion of the tubular shaft member, the axially adjacent pairs of the slits being offset from each other in the circumferential direction of the main portion of the tubular shaft member.
In an analogous flexible medical device including a drive shaft field of endeavor, O’Connor teaches such a feature. O’Connor teaches an optical fiber shaft (30) that is torqueable and pushable and thus comprises a drive shaft (Column 5 lines 17-59). O’Connor teaches wherein the optical fiber composite shaft may be used with a guide catheter (Column 1 lines 5-13, Column 2 lines 10-13). O’Connor teaches wherein the shaft (42) includes notches in the form of alternating laterally arranged slits (44, 46) to produce a composite shaft that has a desired flexibility in a specific area of the shaft (Fig. 4A, Column 5 lines 60-67). As shown in figure 4A reproduced below, the axially adjacent slits 44 and 46 are offset from each other in a circumferential direction, and the slits (44, 46) forming each pair are positioned at a common axial position (see slits 44).
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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 the invention of Itou have the pattern of slits be arranged alternating laterally as taught by O’Connor (Fig. 4A, Column 5 lines 60-67). The arrangement taught by O’Connor may predictably cause a specific area in the shaft to have a desired flexibility, torqueability, and pushability as recognized by O’Connor (Column 5 lines 60-67).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Itou (US20110224650) in view of Dick (US20090018393) and O’Connor (US6352531) as applied to claim 1 above, and further in view of Scheckel (US20220211996).
Regarding claim 2, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 1.
However, Itou fails to teach wherein an axial length of the coil shaft is 250 mm or more and 1000 mm or less.
In an analogous catheter with a drive shaft field of endeavor, Scheckel teaches such a feature. Scheckel teaches a catheter (1) with a flexible drive shaft (2) (Fig. 1, [0069]). Scheckel teaches wherein the axial length of the drive shaft typically lies in a region between 80 cm and 150 cm ([0011]). Scheckel therefore teaches wherein the length may be between 800 mm and 1500 mm, which overlaps with 250 mm and 1000 mm.
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 the invention of Itou to have the axial length of the drive shaft be between 800 mm and 1500 mm as taught by Scheckel ([0011]). This length is recognized as typical, i.e. conventional, and also a rule as recognized by Scheckel ([0011]). Since Itou teaches wherein the drive shaft comprises the coil shaft, Itou modified by the teachings of Scheckel would predictably result in the coil shaft having an axial length between 250 mm and 1000 mm. An ordinarily skilled artisan would recognize to modify or adjust the length of the catheter and drive shaft such that it may sufficiently reach areas of interest within a patient.
Claims 9-11 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Itou (US20110224650) in view of Dick (US20090018393) and O’Connor (US6352531) as applied to claims 8 and 14 above, and further in view of Van (US20180368934).
Regarding claim 9, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 8.
Itou in view of Dick above in claim 8 teaches wherein the tubular shaft member may have a gradient or graded slit density, thus comprising a main portion (17) and weakened portion (18).
However, the combination noted above fails to expressly teach wherein the tubular shaft member includes a weakened portion having lower torsional strength than a torsional strength of the main portion and the coil shaft.
In an analogous catheter field of endeavor, Van teaches such a feature. Van teaches a catheter (1) having a shaft comprising a distal section (21) and a proximal section (22) (Fig. 2, [0027], [0035]). Van teaches wherein the proximal section (22) has a lower torsional stiffness than the distal section (21) (Abstract, [0044]). Van therefore teaches wherein a proximal section, i.e. a tubular shaft member, may have a section of lower torsional strength than a distal section, i.e. a coil shaft 42 of Itou.
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 the invention of Itou to have a proximal section of the tubular shaft member have lower torsional stiffness than a distal section as taught by Van (Abstract, [0044]). In this configuration, torque applied to the distal section may be absorbed by the proximal section, facilitating optical shape sensing and thus tracking of the catheter as recognized by Van (Abstract, [0005-0007]). Since Itou in view of Dick teaches a tubular shaft member with graded slit density thus comprising a main portion (17) and weakened portion (18), and wherein the coil shaft (42) is a distal section, Itou modified by the teachings of Van to have a proximal portion have lower torsional stiffness than the distal section would predictably result in a proximal weakened portion (18) having a lower torsional stiffness than the distal coil shaft (42) and the main portion (17).
Regarding claim 10, Itou in view of Dick, O’Connor, and Van teaches the invention as claimed above in claim 9.
However, Itou fails to teach wherein a plurality of slits are disposed in the weakened portion in a pattern identical to the pattern of the plurality of slits in the main portion, except that a width of the slits in the weakened portion is smaller than the width of the slits in the main portion and/or a pitch of the slits in the weakened portion is smaller than the pitch of the slits in the main portion.
In an analogous catheter field of endeavor, Dick and Itou teaches such a feature. Dick teaches wherein slots, holes, or other aperture shape formations may be formed by means of cutting or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft (400) while retaining substantial torsional rigidity ([0055]). Dick thus provides motivation and reason to include a plurality of slits in the tubular shaft member for increased flexibility.
Itou teaches wherein a plurality of slits are disposed in a weakened portion (18) in a pattern (spiral) identical to the pattern of the plurality of slits in a main portion (17), except that a width of the slits in the weakened portion (18) is smaller than the width of the slits in the main portion (17) and/or a pitch of the slits in the weakened portion (18) is smaller than the pitch of the slits in the main portion (17) (Fig. 6, [0061], [0063], [0068-0069]).
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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 the invention of Itou to have the weakened portion of the tubular shaft member include a smaller pitch than the main portion as taught by Dick ([0055]) and Itou (Fig. 6, [0061], [0063], [0068-0069]). By adjusting pitch density in such a manner, a desired flexibility may predictably be provided for a given section.
Regarding claim 11, Itou in view of Dick, O’Connor, and Van teaches the invention as claimed above in claim 9.
However, Itou fails to teach wherein the weakened portion is proximal the main portion.
In an analogous catheter field of endeavor, Dick and Itou teaches such a feature. Dick teaches wherein slots, holes, or other aperture shape formations may be formed by means of cutting or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft (400) while retaining substantial torsional rigidity ([0055]). Dick thus provides motivation and reason to include a plurality of slits in the tubular shaft member for increased flexibility.
Itou teaches wherein a weakened portion (18) is proximal a main portion (17) (Figs. 6-9, [0061], wherein portion 18 having a higher slit density than portion 17 implies it being weaker and thus a weakened portion, [0064-0065], Fig. 7).
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 the invention of Itou to have the weakened portion be proximal the main portion as taught by Dick ([0055]) and Itou (Fig. 6, [0061], [0063], [0068-0069]). Greater flexibility, e.g. for steering, may be provided at the proximal weakened portion as recognized by Itou ([0099]).
Regarding claim 19, Itou in view of Dick and O’Connor teaches the invention as claimed above in claim 14.
However, Itou fails to teach wherein the tubular shaft member includes a weakened portion positioned proximal of the main portion of the tubular shaft member, the weakened portion including a plurality of slits, the weakened portion having a lower torsional strength than a torsional strength the main portion.
In an analogous catheter field of endeavor, Dick and Itou teaches such a feature. Dick teaches wherein slots, holes, or other aperture shape formations may be formed by means of cutting or other means to generate designs in the tubular structure which permit additional flexibility of the distal region of the hypotube metal shaft (400) while retaining substantial torsional rigidity ([0055]). Dick thus provides motivation and reason to include a plurality of slits in the tubular shaft member for increased flexibility.
Itou teaches wherein a tubular shaft member (13) includes a weakened portion (18) positioned proximal of a main portion (17) of the tubular shaft member, the weakened portion (18) including a plurality of slits (14), the weakened portion (18) having a lower torsional strength than a torsional strength of the main portion (17) (Fig. 6, [0010], [0061], [0064-0065], wherein higher slit density of proximal slit portion 18 compared to intermediate portion 17 results in it having lower torsional strength than the intermediate slit portion 17 and thus comprise a weakened portion).
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 the invention of Itou to have a weakened portion of the tubular shaft member proximal a main portion include a smaller pitch than the main portion as taught by Dick ([0055]) and Itou (Fig. 6, [0061], [0063], [0068-0069]). By adjusting pitch density in such a manner, a desired flexibility may predictably be provided for a given section, thus also affecting torsional strength.
However, Itou fails to teach the weakened portion having a lower torsional strength than a torsional strength of the coil shaft.
In an analogous catheter field of endeavor, Van teaches such a feature. Van teaches a catheter (1) having a shaft comprising a distal section (21) and a proximal section (22) (Fig. 2, [0027], [0035]). Van teaches wherein the proximal section (22) has a lower torsional stiffness than the distal section (21) (Abstract, [0044]). Van therefore teaches wherein a proximal section, i.e. a tubular shaft member, may have a section of lower torsional strength than a distal section, i.e. a coil shaft 42 of Itou.
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 the invention of Itou to have a proximal section of the catheter have lower torsional stiffness than a distal section as taught by Van (Abstract, [0044]). In this configuration, torque applied to the distal section may be absorbed by the proximal section, facilitating optical shape sensing and thus tracking of the catheter as recognized by Van (Abstract, [0005-0007]). Since Itou in view of Dick teaches a tubular shaft member with graded slit density thus comprising a main portion (17) and weakened portion (18), and wherein the coil shaft (42) is a distal section, Itou modified by the teachings of Van to have a proximal portion have lower torsional stiffness than the distal section would predictably result in a proximal weakened portion (18) having a lower torsional stiffness than the distal coil shaft (42).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TOMMY T LY whose telephone number is (571) 272-6404. The examiner can normally be reached M-F 12:00pm-8:00pm eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anhtuan Nguyen can be reached at 571-272-4963. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TOMMY T LY/ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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