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 .
Priority
This application is a continuation of PCT/JP2021/035186 filed 09/24/2021. This application also claims foreign priority to application JP2020-163874 filed 09/29/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted were filed on 03/15/2023, 04/20/2023, and 04/22/2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election of Group I (Claims 1-19) in the reply filed on 03/17/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/17/2026.
Claim Objections
Claim 7 is objected to because of the following informalities:
“extends less than entirety of a circumferential extent” should be corrected to: “extends less than an entirety of a circumferential extent”
Claim 19 is objected to because of the following informalities:
“main portion of the shaft member” should be corrected to:
“main portion of the tubular shaft member”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 11 recites the limitation "the weakened portion". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, it will be interpreted for there to be “a weakened portion” in the invention.
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, 3-4, 8, 11, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Itou (US20110224650) in view of Castaneda (US5279596).
Regarding claim 1, Itou teaches an image core drive shaft (42, 13) that is to be used in an image diagnosis catheter (Figs. 1-2 & 6, [0033-0034], [0038], [0055]), the image core drive shaft (42, 13) 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]); and
a shaft member (13) fixed to the proximal end of the coil shaft (42) (Figs. 1 & 5-6, [0053], [0055], wherein figures 1 & 5 shows the shaft member 13 being fixed to a proximal end of the coil shaft 42 at connector 33).
However, Itou fails to explicitly teach the shaft member having higher torsional stiffness than torsional stiffness of the coil shaft.
In an analogous catheter field of endeavor, Castaneda teaches such a feature. Castaneda teaches a catheter (10) with a proximal portion (14) and a distal portion (22) (Fig. 1, Column 2 line 60 – Column 3 line 29). Castaneda teaches the distal portion (22) includes a coil (28) which enables the distal portion (22) to be twisted with significantly reduced torsion resistance compared to the proximal portion (14) (Column 3 lines 50-59). Castaneda teaches the proximal portion (14) has greater torsional stiffness than the distal portion (22) (Abstract, Column 1 lines 64-68, Column 5 lines 33-38).
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 proximal portion of a catheter have greater torsional stiffness than the distal portion as taught by Castaneda (Abstract, Column 1 lines 64-68, Column 5 lines 33-38). Greater torsional stiffness at the proximal portion enables effective transmission of torque or rotation, allowing for the catheter to be reliably rotated from a proximal end to cause the distal end to rotate a substantially equal amount as recognized by Castaneda (Column 1 lines 17-23). Since Itou teaches wherein the proximal portion of the catheter comprises the shaft member (13) and the distal portion comprises the coil shaft (42), Itou modified by the teachings of Castaneda to have the proximal portion have a greater torsional stiffness than the distal portion would predictably result in the shaft member (13) having higher torsional stiffness than torsional stiffness of the coil shaft (42).
Regarding claim 3, Itou in view of Castaneda teaches the invention as claimed above in claim 1
Itou further teaches wherein an axial length of the shaft member (13) is 200 mm or more and 1750 mm or less (Fig. 6, [0061], wherein the shaft member 13 includes a distal portion 15, a first intermediate portion 16, a second intermediate portion 17, and a proximal portion 18, [0066], “length of the distal slit portion 15 is preferably around 10 mm to 100 mm”, [0067], “length of the first intermediate slit portion 16 is preferably around 50 mm to 250 mm”, [0068], “The length of the second intermediate slit portion 17 is preferably around 500 mm to 900 mm”, [0072], “The length of the proximal slit portion 18 is 20 mm”, wherein 100 + 250 + 500 + 20 = 870 mm shaft member length).
Regarding claim 4, Itou in view of Castaneda teaches the invention as claimed above in claim 1.
Itou further teaches wherein the shaft member (13) is a tubular member that possesses an outer surface provided with a notch (14) (Figs. 6, 8-9, & 12, [0055], wherein the spiral slits 14 comprise notches).
Regarding claim 8, Itou in view of Castaneda teaches the invention as claimed above in claim 1.
Itou further teaches wherein the shaft member (13) includes 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, [0061], [0068], “The slit pitch of the second intermediate slit portion 17 is preferably around 3 mm to 6 mm”).
Regarding claim 11, Itou in view of Castaneda teaches the invention as claimed above in claim 8.
Itou further teaches wherein the weakened portion (18) is proximal the 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).
Regarding claim 13, Itou in view of Castaneda 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, 13) according to Claim 1 (Figs. 1-2 & 6, [0033-0034], [0038], [0055]); 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, 13), 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) (Fig. 2, [0038], [0040], [0055]),
the drive shaft (42, 13) comprising: a tubular shaft member (13) and 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, the tubular shaft member (13) possessing a distal end and a proximal end, the distal end of the tubular shaft member (13) being connected to the tubular coil shaft (42), 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),
the tubular shaft member (13) being comprised of a main portion (17) that extends from the distal end of the tubular shaft toward the proximal end of the tubular shaft member (13), the tubular shaft member including a plurality of slits (14) that are axially spaced apart from one another (Figs. 6-9, [0061]).
However, Itou fails to explicitly teach the 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, Castaneda teaches such a feature. Castaneda teaches a catheter (10) with a proximal portion (14) and a distal portion (22) (Fig. 1, Column 2 line 60 – Column 3 line 29). Castaneda teaches the distal portion (22) includes a coil (28) which enables the distal portion (22) to be twisted with significantly reduced torsion resistance compared to the proximal portion (14) (Column 3 lines 50-59). Castaneda teaches the proximal portion (14) has greater torsional stiffness than the distal portion (22) (Abstract, Column 1 lines 64-68, Column 5 lines 33-38).
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 proximal portion of a catheter have greater torsional stiffness than the distal portion as taught by Castaneda (Abstract, Column 1 lines 64-68, Column 5 lines 33-38). Greater torsional stiffness at the proximal portion enables effective transmission of torque or rotation, allowing for the catheter to be reliably rotated from a proximal end to cause the distal end to rotate a substantially equal amount as recognized by Castaneda (Column 1 lines 17-23). Since Itou teaches wherein the proximal portion of the catheter comprises the shaft member (13), which includes the main portion (17), and the distal portion comprises the coil shaft (42), Itou modified by the teachings of Castaneda to have the proximal portion have a greater torsional stiffness than the distal portion would predictably result in the main portion (17) of the shaft member (13) having higher torsional stiffness than a torsional stiffness of the coil shaft (42).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Itou (US20110224650) in view of Castaneda (US5279596) as applied to claim 1 above, and further in view of Scheckel (US20220211996).
Regarding claim 2, Itou in view of Castaneda 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 5-7, 12, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Itou (US20110224650) in view of Castaneda (US5279596) as applied to claims 4, 8, and 14 above, and further in view of O’Connor (US6352531).
Regarding claim 5, Itou in view of Castaneda teaches the invention as claimed above in claim 4.
However, Itou fails to teach wherein the notch 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 Castaneda teaches the invention as claimed above in claim 4.
However, Itou fails to teach wherein the notch includes a plurality of pairs of slits, the pairs of slits being axially spaced apart along a length of the tube, 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 Castaneda teaches the invention as claimed above in claim 4.
However, Itou fails to teach wherein the notch includes a plurality of slits each of which extends along less than entirety of a circumferential extent of the tubular 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 12, Itou in view of Castaneda 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 15, Itou in view of Castaneda 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 Castaneda 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 Castaneda 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 Castaneda 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).
Claims 9-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Itou (US20110224650) in view of Castaneda (US5279596) as applied to claims 8 and 14 above, and further in view of Van (US20180368934).
Regarding claim 9, Itou in view of Castaneda teaches the invention as claimed above in claim 8.
Itou further teaches wherein the shaft member (13) includes a 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).
However, Itou fails to teach wherein the shaft member includes a weakened portion having 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 weakened portion 18 of Itou, has a 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 teaches wherein the weakened portion (18) is a proximal section and wherein the coil shaft (42) is a distal section, Itou modified by the teachings of Van to have the proximal portion have lower torsional stiffness than the distal section would predictably result in the proximal weakened portion (18) having a lower torsional stiffness than the distal coil shaft (42).
Regarding claim 10, Itou in view of Castaneda and Van teaches the invention as claimed above in claim 9.
Itou further teaches wherein a plurality of slits are disposed in the weakened portion (18) in a pattern (spiral) identical to the pattern of the slits in the 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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Regarding claim 19, Itou in view of Castaneda teaches the invention as claimed above in claim 14.
Itou further teaches wherein the tubular shaft member (13) includes a weakened portion (18) positioned proximal of the main portion (17) of the shaft member, the weakened portion (18) including a plurality of slits (14), the weakened portion 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).
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 weakened portion 18 of Itou, has a 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 teaches wherein the weakened portion (18) is a proximal section and wherein the coil shaft (42) is a distal section, Itou modified by the teachings of Van to have the proximal portion have lower torsional stiffness than the distal section would predictably result in the proximal weakened portion (18) having a lower torsional stiffness than the distal coil shaft (42).
Conclusion
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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/TOMMY T LY/ Examiner, Art Unit 3797 /SERKAN AKAR/ Primary Examiner, Art Unit 3797
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