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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/02/2026 has been entered.
Response to Amendment
Claims 1-8 and 11-20 are pending.
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.
Claims 5-7 are 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.
Regarding claim 5, the limitation “the first region in the shaft part includes at least part of the notch” renders the claim indefinite. It is unclear how the notch can only be located in the second region as recited in claim 1, while also having a part of the notch be in the first region. For examination purposes, the notch shall only be considered as being in the second region.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable by Yokomizo et al., (JP2018121701A) (translation provided by Examiner) in view Sarabia et al., (US20160193449A1)
Regarding claim 1, Yokomizo teaches A catheter comprising a shaft part (fig. 1 sheath 2 pg. 3 line 105) having:
a cylindrical first shaft having a guide wire lumen into which a guide wire is inserted (see annotated fig. 2 guide wire 100 goes through the first shaft. The tubes 221 and 231 form the first shaft assembly); and
a cylindrical second shaft having an imaging lumen into which an imaging device for acquiring an image of an interior of a living body lumen is inserted (see annotated fig. 2 transducer unit 41), the second shaft being disposed alongside the first shaft (see annotated fig. 2 the imaging lumen and guidewire lumen are alongside one another), wherein
in a first region from a first position at a distal end portion of the shaft part to a second position further on a proximal end side than the first position, the second shaft is not joined to the first shaft (see annotated fig. 2, the distal portion of the guide wire lumen is not joined to the imaging lumen), and
in a second region that is continuous with the first region and that is further on the proximal end side than the first region, the second shaft is joined to the first shaft (see annotated fig. 2 the proximal portions of the lumens are joined);
the first shaft includes an opening communicating with the guide wire lumen at a position on a proximal end side of a distal end in the first shaft, the opening being located only in the second region (see annotated fig. 2, the first shaft has an opening on the proximal end side of the distal end of the first shaft and is only in the second region).
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While Yokomizo teaches the opening, it is silent regarding a notch.
In the same catheter field of endeavor, Sarabia teaches a notch (fig. 3 guidewire notch 144).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the opening of Yokomizo to be a continuous guidewire notch as taught by Sarabia, as this would permit the guidewire to stay in place and continue to provide mechanical stability to the system without restricting the device from deflecting when manipulated (see Sarabia [0047]).
Claims 2 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia as applied to claim 1 above, and further in view of Howell (US 20210069471 A1).
Regarding claim 2, modified Yokomizo teaches the catheter of claim 1, wherein Yokomizo further teaches the third and fourth region (see annotated fig. 1 and 2) but fails to explicitly disclose wherein a minimum value of a wall thickness of the shaft part at a position of the guide wire lumen in a third region that includes the first region in the shaft part is smaller than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in a fourth region that is continuous with the third region and that is positioned further on the proximal end side than the third region.
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However in the same catheter field of endeavor, Howell teaches wherein a minimum value of a wall thickness of the shaft part at a position of the guide wire lumen in a fourth region that includes the first region in the shaft part is smaller than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in a fifth region that is continuous with the fourth region and that is positioned further on the proximal end side than the fourth region (see annotated fig. 1B, the minimum thickness at the fourth region is smaller than the minimum thickness of the fifth region).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the thickness of the shaft parts of Yokomizo with the variable thickness of Howell, as this would help facilitate the insertion step of operating a catheter (see Howell [0079]).
Regarding claim 3, modified Yokomizo teaches the catheter of claim 2, but fails to explicitly disclose wherein the third region in the shaft part includes a first small region and a second small region that is continuous with the first small region and that is positioned further on the proximal end side than the first small region, and wherein a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the second small region is larger than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the first small region.
In the same catheter field of endeavor, Howell teaches wherein the fourth region in the shaft part includes a first small region and a second small region that is continuous with the first small region and that is positioned further on the proximal end side than the first small region, and wherein a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the second small region is larger than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the first small region (see annotated fig. 1B below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the thickness of the shaft parts of modified Yokomizo with the variable thickness of Howell, as this would help facilitate the insertion step of operating a catheter (see Howell [0079]).
Claims 4, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia and Howell as applied to claim 3 above, and further in view of Cottone (US20200398025A1).
Regarding claim 4, modified Yokomizo teaches the catheter of claim 3, where Yokomizo but fails to explicitly teach wherein the first position is positioned on a proximal end side of a distal end of the second shaft, and wherein the second shaft is joined to the first shaft in a third region that is continuous with the first region in the shaft part and that is positioned further on a distal end side than the first region.
However in the same catheter field of endeavor, Cottone teaches wherein the first position is positioned on a proximal end side of a distal end of the second shaft (see annotated fig. 1), and wherein the second shaft is joined to the first shaft in a third region that is continuous with the first region in the shaft part and that is positioned further on a distal end side than the first region (see annotated fig. 1 and 7, the tube segment 24 and catheter body 12 are only joined at the distal and proximal joints 30 and 28 [0043] ).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Yokomizo with the attachment points of Cottone, as this would provide improved rotational and torqueability characteristics (see Cottone [0044]).
Regarding claim 5, modified Yokomizo teaches the catheter of claim 4, wherein Yokomizo teaches wherein the second region in the shaft part includes at least a part of the opening (see annotated fig. 2, the opening is only in the second region).
While Yokomizo teaches the opening, it is silent regarding a notch.
In the same catheter field of endeavor, Sarabia teaches a notch (fig. 3 guidewire notch 144).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the opening of modified Yokomizo to be a continuous guidewire notch as taught by Sarabia, as this would permit the guidewire to stay in place and continue to provide mechanical stability to the system without restricting the device from deflecting when manipulated (see Sarabia [0047]).
Regarding claim 7, modified Yokomizo teaches the catheter of claim 5, wherein Yokomizo further teaches the second region in the shaft part includes part of the opening (see annotated fig. 2 the second region contains part of the Opening).
While Yokomizo teaches the opening, it is silent regarding a notch.
In the same catheter field of endeavor, Sarabia teaches a notch (fig. 3 guidewire notch 144).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the opening of Yokomizo to be a continuous guidewire notch as taught by Sarabia, as this would permit the guidewire to stay in place and continue to provide mechanical stability to the system without restricting the device from deflecting when manipulated (see Sarabia [0047]).
Claims 6 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia, Howell, and Cottone as applied to claim 5 above, and further in view of Rahimzadeh et al., (US11980407B1).
Regarding claim 6, modified Yokomizo teaches the catheter of claim 5, but fails to explicitly disclose a cylindrical third shaft having a guide wire lumen into which a guide wire is inserted.
In the same catheter field of endeavor, Rahimzadeh teaches a cylindrical third shaft having a guide wire lumen into which a guide wire is inserted (fig. 5 lumen 1400 and 1300 are lumens that both hold a guidewire (1401 and 1301, respectively) for insertion col. 5 line 59-61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Yokomizo with the additional guidewire lumen of Rahimzadeh, as this would ease the use for physicians, by enhancing the physicians with only a single catheter to manipulate rather than multiple (see col. 5 line 67 – col. 6 line 3).
Claim 8 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia as applied to claim 1 above, and further in view of Cottone.
Regarding claim 8, modified Yokomizo teaches the catheter of claim 1, where Yokomizo but fails to explicitly teach wherein the first position is positioned on a proximal end side of a distal end of the second shaft, and wherein the second shaft is joined to the first shaft in a third region that is continuous with the first region in the shaft part and that is positioned further on a distal end side than the first region.
However in the same catheter field of endeavor, Cottone teaches wherein the first position is positioned on a proximal end side of a distal end of the second shaft (see annotated fig. 1), and wherein the second shaft is joined to the first shaft in a third region that is continuous with the first region in the shaft part and that is positioned further on a distal end side than the first region (see annotated fig. 1 and 7, the tube segment 24 and catheter body 12 are only joined at the distal and proximal joints 30 and 28 [0043] ).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Yokomizo with the attachment points of Cottone, as this would provide improved rotational and torqueability characteristics (see Cottone [0044]).
Claim 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia as applied to claim 1 above, and further in view of Yamaguchi et al., (US 20050101870 A1).
Regarding claim 11, Yokomizo teaches the catheter of claim 1, but fails to explicitly disclose a marker in the first shaft, the marker being closer to the distal end portion of the shaft than the notch.
In the same catheter field of endeavor, Yamaguchi teaches a marker in the first shaft, the marker being in the second region and spaced from the notch, the marker being closer to the distal end portion of the shaft than the notch (see annotated fig. 1 distal portion 21 has a marker 29 and is past the opening aperture and is closer to the distal end portion[0043])
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Yokomizo with the marker of Yamaguchi, as this would ensure positioning confirmation of the catheter (see Yamaguchi [0043]).
Claims 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia as applied to claim 1 above, and further in view of Rahimzadeh.
Regarding claim 12, modified Yokomizo teaches the catheter of claim 1, but fails to explicitly disclose a cylindrical third shaft having a guide wire lumen into which a guide wire is inserted.
In the same catheter field of endeavor, Rahimzadeh teaches a cylindrical third shaft having a guide wire lumen into which a guide wire is inserted (fig. 5 lumen 1400 and 1300 are lumens that both hold a guidewire (1401 and 1301, respectively) for insertion col. 5 line 59-61).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Yokomizo with the additional guidewire lumen of Rahimzadeh, as this would ease the use for physicians, by enhancing the physicians with only a single catheter to manipulate rather than multiple (see col. 5 line 67 – col. 6 line 3).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia and Rahimzadeh as applied to claim 12 above, and further in view of Tobin et al., (US20220126064A1).
Regarding claim 13, modified Yokomizo teaches the catheter of claim 12, but fails to explicitly disclose wherein a distal end of the third shaft is positioned further on the proximal end side than a distal end of the second shaft and the distal end of the third shaft is in the first region.
However in the same catheter field of endeavor, Tobin teaches wherein a distal end of the third shaft is positioned further on the proximal end side than a distal end of the second shaft and the distal end of the third shaft is in the first region (fig. 2C guidewire 194C is positioned on the proximal end of the guidewire 194B and shaft 196A and is the first region).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Yokomizo with the third shaft properties of Tobin, as this would reduce overall time required to place the catheter is reduced, reducing patient down time and improving patient outcomes (see Tobin Abstract).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia as applied to claim 1 above, and further in view of Yamaguchi.
Regarding claim 14, Yokomizo teaches the catheter of claim 1, but fails to explicitly disclose a marker in the first shaft.
In the same catheter field of endeavor, Yamaguchi teaches a marker in the first shaft (fig. 1 distal portion 21 has a marker 29 and is past the aperture opening [0043])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Yokomizo with the marker of Yamaguchi, as this would ensure positioning confirmation of the catheter (see Yamaguchi [0043]).
Regarding claim 15, Yokomizo teaches the catheter of claim 14, but fails to explicitly disclose the marker is in the first region.
In the same catheter field of endeavor, Yamaguchi teaches the marker is in the first region (see annotated fig. 1 distal portion 21 has a marker 29 and is past the aperture opening and would be part of the first region[0043])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of Yokomizo with the marker of Yamaguchi, as this would ensure positioning confirmation of the catheter (see Yamaguchi [0043]).
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Claim 16 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia and Yamaguchi as applied to claim 14 above, and further in view of Makower et al., (US 20010047165 A1).
Regarding claim 16, modified Yokomizo teaches the catheter of claim 14, but fails to explicitly disclose wherein the marker is in the second region.
In the same catheter field of endeavor, Makower teaches wherein the marker is in the second region (fig. 4k energy emitter acts as a marker and is located in the second region [0126]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the catheter of modified Yokomizo with the marker of Makower, as this would enhance visibility of the imaging apparatus (see Makower [0126]).
Claim 17 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia and as applied to claim 1 above, and further in view of Yamaguchi.
Regarding claim 17, modified Yokomizo teaches the catheter of claim 1, but fails to explicitly disclose comprising an outer shaft that covers the first shaft and the second shaft in at least a part of the second region.
In the same catheter field of endeavor, Yamaguchi teaches comprising an outer shaft that covers the first shaft and the second shaft in at least a part of the second region (fig. 8 the lumens 26d and 23D are surrounded by tube 70 [0068]), the first shaft and the shaft being in contact with one another (fig. 2 lumens 28 and 23 contact each other)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the second region of the catheter of modified Yokomizo to incorporate the outer tube of Yamaguchi, as both inventions relate to dual lumen imaging catheters, and would yield the predictable result of a region of a dual lumen catheter that has a tube that surrounds both lumens to one of ordinary skill in the art. One of ordinary skill would be able to perform such a combination, and the results of modified Yokomizo having an outer tube to hold the dual lumens inside are reasonably.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Cottone.
Regarding claim 18, Yokomizo teaches A catheter comprising a shaft part (fig. 1 sheath 2 pg. 3 line 105) having:
a cylindrical first shaft having a guide wire lumen into which a guide wire is inserted (see annotated fig. 2 guide wire 100 goes through the first shaft. The tubes 221 and 231 form the first shaft assembly); and
a cylindrical second shaft having an imaging lumen into which an imaging device for acquiring an image of an interior of a living body lumen is inserted (see annotated fig. 2 transducer unit 41), the second shaft being disposed alongside the first shaft (see annotated fig. 2 the imaging lumen and guidewire lumen are alongside one another), wherein
in a first region from a first position at a distal end portion of the shaft part to a second position further on a proximal end side than the first position (see annotated fig. 2)
in a second region that is continuous with the first region and that is further on the proximal end side than the first region, the second shaft is joined to the first shaft (see annotated fig. 2 the second region is continuous with the first region and is further proximal than the first region, and the proximal portions of the lumens are joined);
and both the first shaft and the second shaft extend continuously at least in an entirety of the first region and an entirety of the second region (see annotated fig. 2, both shafts extend continuously in the entirety of the first and second regions)
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However, Yokomizo fails to explicitly disclose the second shaft contacts the first shaft but is not joined to the first shaft.
In the same catheter field of endeavor, Cottone teaches the second shaft contacts the first shaft but is not joined to the first shaft (fig. 2 the tube segment 24 is unsecured/unattached to the catheter 12, but is still able to contact the catheter [0043]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the first region of Yokomizo to be unattached/unsecured as taught by Cottone, as this would improve the ability of the physician to position the guidewires and/or the auxiliary devices (see Cottone [0054]).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Cottone as applied to claim 18 above, and further in view of Howell.
Regarding claim 19, modified Yokomizo teaches the catheter of claim 18, wherein Yokomizo further teaches the third and fourth region (see annotated fig. 1 and 2) but fails to explicitly disclose wherein a minimum value of a wall thickness of the shaft part at a position of the guide wire lumen in a third region that includes the first region in the shaft part is smaller than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in a fourth region that is continuous with the third region and that is positioned further on the proximal end side than the third region.
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However in the same catheter field of endeavor, Howell teaches wherein a minimum value of a wall thickness of the shaft part at a position of the guide wire lumen in a fourth region that includes the first region in the shaft part is smaller than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in a fifth region that is continuous with the fourth region and that is positioned further on the proximal end side than the fourth region (see annotated fig. 1B, the minimum thickness at the fourth region is smaller than the minimum thickness of the fifth region).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the thickness of the shaft parts of modified Yokomizo with the variable thickness of Howell, as this would help facilitate the insertion step of operating a catheter (see Howell [0079]).
Regarding claim 20, modified Yokomizo teaches the catheter of claim 19, but fails to explicitly disclose wherein the third region in the shaft part includes a first small region and a second small region that is continuous with the first small region and that is positioned further on the proximal end side than the first small region, and wherein a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the second small region is larger than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the first small region.
In the same catheter field of endeavor, Howell teaches wherein the fourth region in the shaft part includes a first small region and a second small region that is continuous with the first small region and that is positioned further on the proximal end side than the first small region, and wherein a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the second small region is larger than a minimum value of the wall thickness of the shaft part at a position of the guide wire lumen in the first small region (see annotated fig. 1B below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the thickness of the shaft parts of modified Yokomizo with the variable thickness of Howell, as this would help facilitate the insertion step of operating a catheter (see Howell [0079]).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are unpersuasive. Examiner’s use of fig. 2 of Yokomizo has been changed so that only the second region contains the notch/opening as required by claim 1. This, in combination with Sarabia, would result in a notch being only in the second region.
Further, regarding claim 18, Cottone has been brought in to teach the additional claim limitations of claim 18, and therefore Applicant’s arguments 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. Further, Examiner’s use of Yokomizo of fig. 2 has been changed so that the first region and second region are continuous in its entirety.
Therefore, the claims remain rejected.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at 5712722714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
