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 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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Butler (2023/0355206) in view of Altshuler (2023/0218861).
With respect to claims 1, 13, and 20, Butler teaches of an intravascular imaging device 210 and method for imaging a blood vessel comprising a catheter shaft 252 having a proximal region with imaging window 254 and a distal region 256 where the distal end region has a guidewire lumen 262 formed therein [0061, fig. 5]. Butler teaches of the catheter shaft 252 to include a telescoping assembly 258 having a telescope hub or inner shaft 266, [0063] configured to be secured to a pullback assembly disposed at or near the proximal end of the catheter assembly 250 [0061-0063, 0066, 0067]. Butler teaches of the telescope hub 280 to include a proximal flange, a loading region or distal shaft member 272 disposed distal of the proximal flange [0064, 0065]. Butler teaches of an imaging core 260 disposed within the catheter shaft 270 [0061, 0063].
With respect to claims 1, 13, and 20, Butler does not explicitly teach of grip region with a non-circular cross-sectional shape. In a similar field of endeavor Altshuler teaches of an ergonomic catheter handle used in IVUS purposes with a pullback system enable catheter deployment and imaging functionality [0031]. Altshuler teaches of handle or grip 24 to be adapted in size and shape to provide an ergonomic grip and may have different shapes and sizes including a triangular cross-section and therefore non-circular cross-sectional shape [0042, fig. 5B]. Altshuler teaches of the grip or handle region to have cross-section that fits into a circle 25 of 25 mm diameter [0072] and therefore under broadest reasonable interpretation, the reference teaches of a D-shaped or semi-circular shape that can fit into a circular cross-section. Altshuler also teaches of the handle to include a strain relief sleeve 26 at the distal end of the handle body 23 and is adapted to irremovably secure the handle body to the catheter probe [0041] and therefore under broadest reasonable interpretation, the handle or grip region has a configuration or shape that is complimentary to the surface of the pullback assembly. Altshuler teaches of the grip or handle to have one or more ribs formed therein or the knurl-like features 27 on the handle body [0043]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Altshuler to modify Butler to provide a handle with proper grip for better support, handling, and manipulations of the unit [Altshuler, 0072, 0073].
With respect to claim 2, Butler in view of Altshuler teaches of the imaging core to be translatable within the catheter shaft [0063].
With respect to claim 3, Butler in view of Altshuler teaches of the imaging core to include an ultrasound transducer [0061].
With respect to claim 4, Butler in view of Altshuler teaches of the imaging core to include an optical coherence tomography imaging device [0061].
With respect to claims 5 and 14, Butler in view of Altshuler teaches of the loading region or distal shaft member 272 to have a substantially circular cross-sectional shaft and is substantially cylindrical shape (fig. 5, 7).
With respect to claims 6, and 15, Butler in view of Altshuler teaches of the loading region or distal shaft member 272 to be configured to engage an attachment region that includes an attachment rod 278 of the pullback assembly [0064].
With respect to claims 7, 8, 16, and 17, Butler does not explicitly teach of the particulars of the grip region and specifically an attachment clip. Altshuler teaches of the length of the handle to be in the range of 1 to 2 times or more the predetermined pullback length/imaging core where the pullback unit is configured to engage with the imaging core to move the imaging core in a lengthwise direction through the shaft [0070, 0071]. Altshuler teaches of the coupling mechanism 21 that couples the handle to the connection port where the coupling mechanism 21 has a length about 45 mm while the handle has a dimension of 133 mm and therefore under broadest reasonable interpretation, the reference teaches of the grip region to be sized larger than the attachment or coupling mechanism [0036, 0042, 0047]. Altshuler also teaches of the coupling mechanism includes a locking feature 21a engaging with a corresponding locking feature such as a locking pin 21b or attachment clip enabling the handle to be attached with a push and twist procedure [0048]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Altshuler to modify Butler to provide a handle with proper grip for better support, hand catheter shaft 270 [0061, 0063].
With respect to claims 9-12, 18, and 19, Butler does not explicitly teach of grip region with a non-circular cross-sectional shape. In a similar field of endeavor Altshuler teaches of an ergonomic catheter handle used in IVUS purposes with a pullback system enable catheter deployment and imaging functionality [0031]. Altshuler teaches of handle or grip 24 to be adapted in size and shape to provide an ergonomic grip and may have different shapes and sizes including a triangular cross-section and therefore non-circular cross-sectional shape [0042, fig. 5B]. Altshuler teaches of the grip or handle region to have cross-section that fits into a circle 25 of 25 mm diameter [0072] and therefore under broadest reasonable interpretation, the reference teaches of a D-shaped or semi-circular shape that can fit into a circular cross-section. Altshuler also teaches of the handle to include a strain relief sleeve 26 at the distal end of the handle body 23 and is adapted to irremovably secure the handle body to the catheter probe [0041] and therefore under broadest reasonable interpretation, the handle or grip region has a configuration or shape that is complimentary to the surface of the pullback assembly. Altshuler teaches of the grip or handle to have one or more ribs formed therein or the knurl-like features 27 on the handle body [0043]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Altshuler to modify Butler to provide a handle with proper grip for better support, handling, and manipulations of the unit [Altshuler, 0072, 0073].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAISAKHI ROY whose telephone number is (571)272-7139. The examiner can normally be reached Monday-Friday 7-3 EST.
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, Christopher Koharski can be reached at 571-272-7230. 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.
BR
/BAISAKHI ROY/ Primary Examiner, Art Unit 3797