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 .
Examiner’s Note
The previous Non-final Office Action mailed 05/28/2026 has been vacated. The present Non-final Office Action supersedes the previous Non-final Office Action. A new time period for response is set according to the mailing date of the present Non-final Office Action.
Specification
The disclosure is objected to because of the following informalities:
[0037], line 6, “second fire 42” should be changed to “second wire 42.”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 1-6, 12, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2014117399 to Nishimura et al. (“Nishimura”) in view of U.S. Patent Publication No. 2002/0068868 to Thompson et al. (“Thompson”).
Regarding claim 1, Nishimura teaches a catheter (Fig. 7a) comprising a shaft (22) having a distal end (distal end of 22), a proximal end (proximal end of 22), and a lumen (lumen of 22) extending in a longitudinal direction, a first wire (41a, Fig. 7b) having a distal end and a proximal end and extending in the lumen of the shaft, the distal end being fixed to a distal end part of the shaft (as better seen in Fig. 4a), and the proximal end being disposed at a proximal end part of the shaft (Fig. 4a), a second wire (41b) having a distal end and a proximal end and extending in the lumen of the shaft, the distal end being fixed to a distal end part of the shaft (Fig. 4a), and the proximal end being disposed at a proximal end part of the shaft (Fig. 4a), a leaf spring (83) disposed in the lumen of the shaft so as to separate the lumen of the shaft into a first part (portion above 83, Fig. 7b) where the first wire is disposed and a second part (portion below 83, Fig. 7b) where the second wire is disposed in the longitudinal direction, and a first coil (81a) having a lumen in which the first wire is disposed (Fig. 7b) and being disposed in the first part, wherein the first coil is fixed to a proximal end side of the leaf spring (Fig. 4a) and the first coil has a total length L1 in its natural state and a total length LC1 at maximum compression, and a ratio LC1/L1 is 0.9 or more ([0027], a 0.5% compression would yield 0.995 ratio), but does not teach the supporting member and the intermediate unfixed portion.
Thompson teaches a supporting member (34, Fig. 3), to which the proximal end of a leaf spring (32) is fixed, extending in the longitudinal direction, having a lumen in which a first wire (62) and a second wire (64) are disposed (Fig. 3), and being disposed proximal to the leaf spring (Fig. 3). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Nishimura with a supporting member as taught by Thompson in order to stiffen the catheter body and to help impart twisting motion from the handle to the steering assembly ([0038]). Once combined, the first coil would be distal to a distal end of the supporting member.
Thompson further teaches a first coil (left 90, Fig. 8) being fixed to a proximal end side of the leaf spring at two or more locations (two solder spots), which include a first fixed portion (upper solder spot), and a second fixed portion (lower solder spot), so that the first coil has at least one unfixed portion including an intermediate unfixed portion (unfixed portion between the upper and lower adhesive spots), which is not fixed to the leaf spring and is located between the first fixed portion and the second fixed portion, the second fixed portion is located proximal to the first fixed portion (Fig. 8). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used two attachment points for the first coil of Nishimura as taught by Thompson to yield the predictable result of providing attachment between a coil and a leaf spring. Nishimura already teaches that the coils are soldered to the leaf spring ([0031]), Thompson merely shows an example of such soldering in an analogous device.
Regarding claim 2, Nishimura and Thompson teach the catheter according to claim 1 as shown above, Thompson further teaching the supporting member is a tubular member (34).
Regarding claim 3, Nishimura and Thompson teach the catheter according to claim 1 as shown above, Nishimura further teaching the first coil is a closely wound coil ([0031]).
Regarding claim 4, Nishimura and Thompson teach the catheter according to claim 1 as shown above, once combined, an outer surface of the first coil is fixed to a surface of the leaf spring at the first fixed portion and the second fixed portion is taught by Thompson while, Nishimura teaches the surface of the leaf spring defining a part of the first part of the lumen of the shaft.
Regarding claim 5, Nishimura and Thompson teach the catheter according to claim 1 as shown above, Thompson further teaching an unfixed portion having a longest length in the longitudinal direction among the at least one unfixed portion has a length in its natural state in the longitudinal direction of 50% or longer of the total length L1 of the first coil in its natural state (Fig. 8).
Regarding claim 6, Nishimura and Thompson teach the catheter according to claim 1 as shown above, Nishimura teaching the first coil being disposed in the first part of the lumen of the shaft, Thompson further teaching the first coil having a distal unfixed portion (portion above upper solder spot), which does not include a fixed portion where the first coil and the leaf spring is fixed, between a distal end of the first coil and the first fixed portion (Fig. 8).
Regarding claim 12, Nishimura and Thompson teach the catheter according to claim 1 as shown above, Nishimura further teaching a third coil (81b) having a lumen, wherein the third coil is disposed in the second part of the lumen of the shaft (Fig. 7b) and the second wire is disposed in the lumen of the third coil (Fig. 7b).
Regarding claim 13, Nishimura and Thompson teach the catheter according to claim 12 as shown above, but does not show the claimed range. wherein the third coil has a total length L3 in its natural state and a total length LC3 at maximum compression, and the ratio LC3/L3 is less than 0.9.
Nishimura discloses that the tightly wound coils may be compressed by varying amounts ([0034]) which would allow for various levels of flexure. The range of the ratio of the length of the coil in a natural state and in a compressed state is a result effective variable in that changing the flexure of the coil would be necessary to suit the particular need or application. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the coil of Nishimura to provide a coil having a compression ratio within the claimed range, as it involves only adjusting the type of coil which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of the total length L3 of the coil in its natural state and a total length LC3 of the coil at maximum compression to be less than 0.9 as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims 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).
Regarding claim 15, Nishimura and Thompson teach the catheter according to claim 1, Nishimura further teaching the first coil is fixed to the leaf spring by welding, soldering, bonding, or crimping at the first fixed part and the second fixed part ([0031]).
Regarding claim 16, Nishimura and Thompson teach the catheter according to claim 1, Thompson further teaching the intermediate unfixed portion has a length in its natural state in the longitudinal direction of 50% or longer of the total length L1 of the first coil in its natural state (Fig. 8).
Claims 7, 8, 10, 11 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Thompson as applied to claim 1 above, and further in view of U.S. Patent Publication 2017/0197060 to Houck.
Regarding claim 7, Nishimura and Thompson teach the catheter according to claim 1 but do not teach a second coil.
Houck teaching a second coil (93B/C) having a lumen in which the first wire is disposed (Fig. 9) and being disposed distal to the first coil (93A). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a first and second coil (or separated the first coil) on the first wire of Nishimura and Thompson as taught by Houck to allow the deflectable catheter to form a complex curve with bends ([0038]). Once combined, the second coil would be disposed in the first part.
Regarding claim 8, Nishimura, Thompson, and Houck teach the catheter according to claim 7 as shown above, but does not teach the claimed range.
Nishimura discloses that the tightly wound coils may be compressed by varying amounts ([0034]) which would allow for various levels of flexure. The range of the ratio of the length of the coil in a natural state and in a compressed state is a result effective variable in that changing the flexure of the coil would be necessary to suit the particular need or application. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the coil of Nishimura to provide a coil having a compression ratio within the claimed range, as it involves only adjusting the type of coil which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of the total length L2 of the coil in its natural state and a total length LC2 of the coil at maximum compression to be less than 0.9 as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims 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).
Regarding claim 10, Nishimura, Thompson, and Houck teach the catheter according to claim 7, Nishimura teaching the first coil is formed of a helically wound first coil wire ([0031]), once combined with Houck, the second coil is formed of a helically wound second coil wire, but does not teach varying the pitch interval.
Houck further teaches a pitch interval of a first coil (91’) being shorter than a pitch interval of a second coil (90’). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to vary pitch intervals in order to vary a shaft radius when the associated wire experiences a longitudinal load ([0035]) in order to allow for greater bending variances to suit the particular need or application.
Regarding claim 11, Nishimura, Thompson, and Houck teach the catheter according to claim 10, once modified by Houck to have a separated original coil, Nishimura, Thompson and Houck would teach a coil wire diameter of the first coil is the same as a coil wire diameter of the second coil, and a coil diameter of the first coil is the same as a coil diameter of the second coil (since the diameter of the original coil all had the same original coil wire diameter and coil diameter).
Regarding claim 14, Nishimura and Thompson teach the catheter according to claim 1, Nishimura further teaching a third coil (81b) having a lumen, the third coil is disposed in the second part of the lumen of the shaft (Fig. 7b), and the second wire is disposed in the lumen of the third coil (Fig. 7b), but do not teach the second coil and the protection tube.
Houck teaches a second coil (93C/B) having a lumen, a first wire (40E) is disposed in the lumen of a first coil (93A) and the lumen of the second coil so that the second coil is located at a distal side of the first coil (Fig. 9). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a first and second coil (or separated the first coil) on the first wire of Nishimura and Thompson as taught by Houck to allow the deflectable catheter to form a complex curve with bends ([0038]). Once combined, the second coil would disposed in the first part of the lumen of the shaft.
Houck further teaching a protection tube (84, Fig. 6) having a lumen, and the protection tube is disposed in the lumen of the shaft so that a leaf spring, a first coil, and a third coil are placed in the lumen of the protection tube (Fig. 6). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified catheter of Nishimura and Thompson with a protection tube as taught by Houck to allow the deflectable catheter shaft section to begin curving from a more distal location than does body coil alone ([0033]) in order to suite various needs and application. Once combined, the second coil would also be placed in the lumen of the protection tube
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Nishimura in view of Thompson and Houck as applied to claim 7 above, and further in view of U.S. Patent Publication 2013/0296781 to Tegg et al. (“Tegg”).
Regarding claim 9, Nishimura, Thompson, and Houck teach the catheter according to claim 7 as shown above, but do not mention stiffness. Tegg generally teaches that coils used in bendable catheters may varied in terms of bending stiffness. It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used different bending stiffnesses in the first and second coils of Nishimura, Thompson, and Houck to yield the predictable result of providing adjustability and customization of the various coil properties to suit a particular need or application. Tegg does not explicitly disclose the claimed difference in bending stiffness between a first and second coil.
However, as previously mentioned, Tegg discloses that the coil properties such as bending stiffness may be adjusted or customized ([0095]). The range of the difference in bending stiffness between the first coil and the second coil is a result effective variable in that changing the bending stiffness of one or both coils would be necessary to suit the particular need or application. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying at least one of the coils of Nishimura, Thompson, and Houck to a difference in bending stiffness within the claimed range, as it involves only adjusting the type of coil which would require adjustment based on the aforementioned factors. Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the difference between the bending stiffness of the first coil and the bending stiffness of the second coil to be 50% or less, as a matter of routing optimization since it has been held that “[W]here the general conditions of a claims 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: CN 203763234, U.S. Patent Publication No. 2014/0135688, WO 2012/098788, and U.S. Patent No. 3,552,384.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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