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 .
Claim Objections
Claim 18 objected to because of the following informalities: line 2 recite “guide wire 5” and should be changed to “guide wire” and line 7 recites “shaft 10” and should be changed to “shaft”. 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.
Claims 9-11 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.
Claim 9 recites the limitation "a notch" in line 2. It is unclear if this the same or different notch as the one in claim 1. For examination purposes, it shall be considered as “the notch”.
Further lines 2-3 recites the limitation "a position on a proximal end side of a distal end". It is unclear if this is the same or different position on the proximal end side of the distal end as recited in claim 1. For examination purposes it shall be considered the same.
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.
Claims 1, 9, and 10 are 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 (see annotated fig. 2, the first shaft has an opening on the proximal end side of the distal end of the first shaft).
PNG
media_image1.png
298
487
media_image1.png
Greyscale
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]).
Regarding claim 9, modified Yokomizo teaches the catheter of claim 1, wherein Yokomizo teaches wherein 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 (see annotated fig. 1 the opening in the first shaft), and wherein the first region in the shaft part includes at least a part of the notch (see annotated fig. 1, part of the first region includes a part of the opening, and thus the notch taught by Sarabia).
PNG
media_image1.png
298
487
media_image1.png
Greyscale
Regarding claim 10, modified Yokomizo teaches the catheter of claim 9, wherein Yokomizo further teaches the second region in the shaft part includes part of the notch(see annotated fig. 2 the second region contains part of the opening, and thus the notch of Sarabia).
PNG
media_image1.png
298
487
media_image1.png
Greyscale
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, the second shaft is not joined to the first shaft (see annotated fig. 2, the distal portion of the guide wire lumen is not jointed 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 second shaft extend continuously at least in a region from a distal end of the first region to a proximal end of the region (see annotated fig. 2, the second shaft extends continuously from the distal end of the first region and extends to the proximal end)
PNG
media_image2.png
298
487
media_image2.png
Greyscale
While Yokomizo teaches the opening, it is silent regarding a notch.
In the same catheter field of endeavor, Sarabia teaches a first shaft extends continuously in a region from a distal end of the first region to a proximal end of the second region (fig. 3 the shaft extends continuously from the distal end to the proximal end [0035]).
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.
PNG
media_image3.png
298
487
media_image3.png
Greyscale
PNG
media_image4.png
343
489
media_image4.png
Greyscale
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).
PNG
media_image5.png
267
747
media_image5.png
Greyscale
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).
PNG
media_image5.png
267
747
media_image5.png
Greyscale
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] ).
PNG
media_image6.png
478
812
media_image6.png
Greyscale
PNG
media_image7.png
630
761
media_image7.png
Greyscale
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 first region in the shaft part includes at least a part of the notch (see annotated fig. 1, part of the first region includes a part of the notch as taught by Sarabia).
PNG
media_image1.png
298
487
media_image1.png
Greyscale
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 notch(see annotated fig. 2 the second region contains part of the Opening/Notch).
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] ).
PNG
media_image6.png
478
812
media_image6.png
Greyscale
PNG
media_image7.png
630
761
media_image7.png
Greyscale
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 closer to the distal end portion of the shaft than the notch (fig. 1 distal portion 21 has a marker 29 and is past the opening aperture[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]).
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]).
PNG
media_image8.png
561
861
media_image8.png
Greyscale
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, Yamashita 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]).
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 Yamashita, 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.
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Yokomizo in view of Sarabia 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.
PNG
media_image3.png
298
487
media_image3.png
Greyscale
PNG
media_image4.png
343
489
media_image4.png
Greyscale
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).
PNG
media_image5.png
267
747
media_image5.png
Greyscale
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).
PNG
media_image5.png
267
747
media_image5.png
Greyscale
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 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. Yokomizo alone has not been used to teach the amended limitations of claim 1. Now it is the combination of Yokomizo and Sarabia that teaches the limitations of amended claim 1.
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 MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL YIMING FANG/Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798