DETAILED ACTION
This action is in response to applicant’s amendment received on September 7th, 2025.
Double Patenting
Claims 9 and 16-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-26 of copending Application No. 17/516,590. Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the invention of claim 9 of the current application and the invention of claims 19-26 of the copending application lies in the fact that the invention of claims 19-26 of the copending application includes more elements and is thus more specific. Thus the invention of claims 19-26 of the copending application is in effect a "species" of the "generic" invention of claims 9 and 16-18 of the current application. It has been held that the generic invention is “anticipated” by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since claims 9 and 16-18 of the current application are anticipated by claims 19-26 of the copending application, claims 9 and 16-18 are not patentably distinct from claims 19-26.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claims 1-9 and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Haim (U.S. Patent 6,203,493) in view of Acker (U.S. Patent 6,161,032) and in view of Jutras (U.S. Publication 2003/0040879).
Regarding claims 1-8:
Ben-Haim discloses a device (for example see Figures 5-6) comprising:
(claim 1) a sensor carrier configured to be removably arranged in a lumen of a medical instrument including (144; column 6 lines 46-51)
(claim 1) at least two localizers (22; column 6 lines 62-64 and column 7 lines 21-42)
(claim 1) wherein each of the localizers are configured for providing a sensor signal representing position and orientation of the localizer
(claim 1) wherein the sensor carrier has a distal end and a proximal end
(claim 2) wherein a first of the localizers are arranged at or near the distal end of the sensor carrier and a second of the localizers are arranged at a distance from the first localizer toward the proximal end of the sensor carrier (for example see Figure 5)
(claim 3) wherein the sensor carrier includes a third localizer configured for providing a sensor signal representing position and orientation of the third localizer arranged a distance from the first and second localizers towards the proximal end of the sensor carrier (for example see Figure 5)
(claim 1) a position detection system (column 8 lines 29-32) configured for determining position and orientation of the at least wo localizers in a position detection system’s coordinate system from received sensor signals
(claim 1) a calibration unit (column 11 lines 20-24) capable of calibrating a medical instrument with the sensor carrier arranged in its lumen by calculating a distance between the medical instrument tip and at least one of the localizers based on the position and orientation of a calibration device and the position and orientation of at least one of the localizers determined by the position detection system
(claim 4) wherein the calibration unit is capable of determining a medical instrument’s virtual longitudinal axis based on the position of the localizers
(claim 5) wherein the calibration unit is capable of extrapolating a medical instrument’s virtual longitudinal axis from the distal end of the sensor carrier and for determining the position of a distal end of the medical instrument in order to calibrate the medical instrument
(claim 6) wherein the calibration unit is capable of automatically detecting whether or not a medical instrument’s tip is in contact with the medical calibration device by determining whether a virtual longitudinal axis defined by the positions of the localizers intersects a known position of a calibration device over a predetermined period of time and for starting automatic calibration of the medical instrument when the tip is found to be in contact with the calibration device
Ben-Haim fails to disclose the device comprising a calibration device and a medical instrument identification unit.
Regarding the device comprising a calibration device, Acker teaches a device comprising a medical instrument (20), a sensor carrier (30), and a position detection system (80 and 100), wherein the device further comprises a calibration device (316) configured such that its position and orientation of the calibration device can be determined in the position detection system’s coordinate system in order to determine the position and orientation of the sensor carrier within the position detection system’s coordinate system (column 8 line 38 to column 10 line 54). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Ben-Haim further comprising a calibration device in view of Acker in order to determine the position and orientation of the sensor carrier within the position detection system’s coordinate system.
Regarding the device comprising a medical instrument identification unit, Jutras teaches a device comprising a medical instrument (S) including a tip (102) sensor carrier (106 and 108) including at least two localizers (110, 112, 114) configured for providing position and orientation, wherein the device further comprises a medical instrument identification unit (C) configured to determine a length between the tip of the instrument and the position of the localizers and the calculated angle of the instrument relative to the instrument identification unit (paragraphs 30-33) and wherein the unit includes a database that contains the different lengths of different medical instruments configured to identify each instrument based on the lengths in the database (paragraph 34) in order to validate the instruments being used in the procedure. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Ben-Haim as modified by Acker further comprising a medical identification unit in view of Jutras in order to validate the instrument being used in the procedure.
The device of Ben-Haim as modified by Acker as further modified by Jutras discloses a device wherein the medical instrument identification instrument is capable of identifying a medical instrument based on the length of the lumen determined by the distance between the localizers and wherein the medical instrument identification instrument is capable of identifying an instrument based on a calculated angle of the medical instrument.
Regarding claims 9 and 16-22:
Ben-Haim discloses a device (for example see Figures 5-6) comprising:
(claim 9) a sensor carrier configured to be removably arranged in a lumen of a medical instrument including (144; column 6 lines 46-51)
(claim 9) at least two localizers (22; column 6 lines 62-64 and column 7 lines 21-42)
(claim 9) wherein each of the localizers are configured for providing a sensor signal representing position and orientation of the localizer
(claim 16) wherein the sensor carrier has a distal end and a proximal end
(claim 16) wherein a first of the localizers are arranged at or near the distal end of the sensor carrier and a second of the localizers are arranged at a distance from the first localizer toward the proximal end of the sensor carrier (for example see Figure 5)
(claim 17) wherein the sensor carrier includes a third localizer configured for providing a sensor signal representing position and orientation of the third localizer arranged a distance from the first and second localizers towards the proximal end of the sensor carrier (for example see Figure 5)
(claim 9) a position detection system (column 8 lines 29-32) configured for determining position and orientation of the at least wo localizers in a position detection system’s coordinate system from received sensor signals
(claim 9) a calibration unit (column 11 lines 20-24) capable of calibrating a medical instrument with the sensor carrier arranged in its lumen by calculating a distance between the medical instrument tip and at least one of the localizers based on the position and orientation of a calibration device and the position and orientation of at least one of the localizers determined by the position detection system
(claim 18) wherein the calibration unit is capable of determining a medical instrument’s virtual longitudinal axis based on the position of the localizers
(claim 19) wherein the calibration unit is capable of extrapolating a medical instrument’s virtual longitudinal axis from the distal end of the sensor carrier and for determining the position of a distal end of the medical instrument in order to calibrate the medical instrument
(claim 20) wherein the calibration unit is capable of automatically detecting whether or not a medical instrument’s tip is in contact with the medical calibration device by determining whether a virtual longitudinal axis defined by the positions of the localizers intersects a known position of a calibration device over a predetermined period of time and for starting automatic calibration of the medical instrument when the tip is found to be in contact with the calibration device
Ben-Haim fails to disclose the device comprising a calibration device, a medical instrument identification unit, and the device comprising a plurality of medical instruments.
Regarding the device comprising a calibration device, Acker teaches a device comprising a medical instrument (20), a sensor carrier (30), and a position detection system (80 and 100), wherein the device further comprises a calibration device (316) configured such that its position and orientation of the calibration device can be determined in the position detection system’s coordinate system in order to determine the position and orientation of the sensor carrier within the position detection system’s coordinate system (column 8 line 38 to column 10 line 54). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Ben-Haim further comprising a calibration device in view of Acker in order to determine the position and orientation of the sensor carrier within the position detection system’s coordinate system.
Regarding the device comprising a medical instrument identification unit, Jutras teaches a device comprising a medical instrument (S) including a tip (102) sensor carrier (106 and 108) including at least two localizers (110, 112, 114) configured for providing position and orientation, wherein the device further comprises a medical instrument identification unit (C) configured to determine a length between the tip of the instrument and the position of the localizers and the calculated angle of the instrument relative to the instrument identification unit (paragraphs 30-33) and wherein the unit includes a database that contains the different lengths of different medical instruments configured to identify each instrument based on the lengths in the database (paragraph 34) in order to validate the instruments being used in the procedure. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Ben-Haim as modified by Acker further comprising a medical identification unit in view of Jutras in order to validate the instrument being used in the procedure.
The device of Ben-Haim as modified by Acker as further modified by Jutras discloses a device wherein the medical instrument identification instrument is capable of identifying a medical instrument based on the length of the lumen determined by the distance between the localizers and wherein the medical instrument identification instrument is capable of identifying an instrument based on a calculated angle of the medical instrument.
Regarding the device comprising a plurality of medical instruments, it would have been obvious to one having ordinary skill in the art at the time the invention was to provide the device of Ben-Haim as modified by Acker as further modified by Jutras further comprising a plurality of medical instruments, i.e. a plurality of endoscopes for different sized patients, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Response to Arguments
Applicant's arguments filed September 7th, 2025 have been fully considered but they are not persuasive. The applicant’s argument that the prior art references used in the prior art rejections do not disclose and/or teach the applicant’s invention as claimed is not persuasive. The examiner has provided detailed prior art rejections showing how the prior art references disclose and/or teach the limitations of the claims as presented. Furthermore, If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). The applicant has not provided arguments and/or evidence to rebut the prima facie case of obviousness.
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 Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775