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) 1-4, 9, 10, 12, 13, 18-21, 26, 27, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eck (2006/0173381).
With respect to claims 1 and 18, Eck teaches of a system and method for measuring relative displacement between two flexible elongate instruments within a body lumen [0012]. Eck teaches of a first flexible elongate instrument such as the guide wire 3 comprising a plurality of spatial encoding markers or structuring 3’ [0009, 0012-0013, 0026] and a second flexible elongate instrument with the inner catheter 2 with sensors 5 or detectors configured to obtain a signal from the markers or structuring 3’ (fig. 4) and the first and second flexible elongate instruments are configured for relative movement within a body lumen or where the inner catheter 2 moves over the guidewire 3 and components are arranged to be capable of moving independently of each other within the body lumen [0025, 0027]. Eck teaches of a controller 6 (fig. 4) configured to measure relative displacement or distance of the first and second elongate instruments based on the signals obtained from the two detectors and a detected offset of the obtained signal or the D1, D2, and D3 distance measurements [0031]. Under broadest reasonable interpretation, Eck teaches of measuring distance or relative displacement of the guide wire and the inner catheter based on the signals obtained from the two detectors and a detected offset of the obtained signals.
With respect to claims 2 and 19, Eck teaches of the sensor offset to be longitudinal offset or shifted in longitudinal direction [0020, 0011, fig. 3].
With respect to claims 3 and 20, Eck teaches of the offset between the sensors to be fixed or a fixed contact point [0026, 0027].
With respect to claims 4 and 21, Eck teaches of the controller configured to determine the relative direction of movement between the instruments based on the offset or the direction of the shifting [0007, 0012, 0031, 0032].
With respect to claims 9 and 26, Eck teaches of the markers or structurings 3’ comprising patterns that varies abut the circumference of the elongate instrument or the guide wire (fig. 5) or with respect to the changing radii of the guide wire [0030].
With respect to claims 10 and 27, Eck teaches of the use of optical detectors wherein the signal element sensor is a single element light sensor such as a photodiode [0028].
With respect to claims 12, 13, 29, and 30, Eck teaches of the energy source configured to deliver continuous energy [0026]. Eck teaches of the energy associated with one source varying with respect to stimulation energy associated with the other source with respect to the timing of the light stimulation [0028].
Eck does not teach of all of the claimed elements in a single embodiment. It would have therefore been obvious to one of ordinary skill in the art to combine the elements from the various embodiments to effectively determine the position or mutual position shift of two elements to improve catheter managements to reduce the burden on the patient [0007, 0008].
Claim(s) 5-8, 14-17, 22-25, 31, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eck in view of Kornblau et al. (2008/0262473).
With respect to claims 5, 7, 8, 22, 24, and 25, Eck does not explicitly teach of determining the change in orientation between the elongate instruments. In a similar field of endeavor Kornblau et al. teach of determining a position of a second object which travels along a first object using a determined position of the first object and a relative linear displacement [0055]. Kornblau et al. teach of detection of change in orientation of two points on a single object and/or coordinating activity of two separate objects [0076]. Kornblau et al. also teach of the controller configured to determining incremental change in position between the first and second instruments or the incremental distance based on the amplitude between the signals [0092-0098].
With respect to claims 6, 14, and 23, Eck does not teach of the specifics of the position of the marker being defined in a coordinate frame of the system and another modality. Kornbalu et al. teach of determining an absolute position of the second instrument in the reference coordinate frame based on the offset of the signals and include a localization sensor or marker for spatial alignment of the markers to a position defined in both a coordinate frame of reference of the system and a coordinate frame of reference of another modality such as ultrasound , CT, radiofrequency, etc. [0063, 0083, 0084, fig. 1].
With respect to claims 15 and 32, Eck does not explicitly teach of a imaging marker. Kornblau et al. teach the use of imaging marker as the localization marker [0060] where the position of the distal tip can be ascertained using an imaging device.
With respect to claims 16, 17, and 31, Kornblau et al. therefore teach of aligning the instruments relative to the localization sensor or marker and registering a position and orientation of the one of the instruments based on the detected position and orientation of the marker or sensor in both a coordinate frame of the system and coordinate frame of reference of another modality [0079-0084]. With respect to claim 17, Kornblau et al. teach of updating a spatial arrangement obtained from the other modality [0063] based on the measured relative displacement of the first and second instruments [0064-0067] or the linear displacement of the guide wire and catheter.
It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Kornblau et al. to modify Eck to more effectively track and determine the linear displacement of a second object relative to the first object and ascertain a position of the second object based upon the relative linear displacement and position of the first object [0008].
Claim(s) 11 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eck in view of Shachar et al. (2007/0197891). Eck does not explicitly teach of the use of a Hall effect plate. In a related field of endeavor Shachar et al. teach of apparatus and method for mapping and ablation catheter that includes Hall effect sensor array [0057, 0061]. The Eck reference teaches of mechanical, electromagnetic, or optical techniques and it would be obvious to use hall sensor array with respect to electromagnetic detection. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Shachar et al. to modify Eck to accurately measure the position of the catheter tip relative to the frame to control the movement of the catheter tip [Shachar, 0061].
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