DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Examiner acknowledges the receipt of the Applicant’s Amendment dated June 12, 2025. Applicant amended claim 21. Claims 1-10, 12-17, and 19-22 are pending.
Applicant's arguments with respect to claims 1, 8, and 15 have been considered and are persuasive. As to Applicant’s arguments regarding Vrba not being in the field of endoscopy, Examiner notes that Vrba teaches energy delivery via a catheter that can be configured to improve visualization as well as providing an endoscope for imaging in [0586] and [0597]. However in order to expedite prosecution upon further search and consideration, the claims are rejected under 35 U.S.C. 103 as discussed below in view of the new grounds of rejection over Sharma et al. (U.S. Publication 2020/0085496) as necessitated by the amendment.
Claim Objections
Applicant has amended Claim 21 and the objection is withdrawn.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-10, 12-17, and 19-22 are rejected under 35 U.S.C. 103 as being unpatentable over Tojo et al. (U.S. Publication 2018/0031493, hereinafter “Tojo”) and in further views of Alvarez Icaza Rivera et al. (U.S. Publication 2009/0085444, hereinafter “Rivera”), Banik et al. (U.S. Publication 2003/0069475, hereinafter “Banik”), Fabro (U.S. Publication 2013/0023758), Vrba et al. (U.S. Publication 2019/0069949, hereinafter “Vrba”), and Sharma et al. (U.S. Publication 2020/0085496, hereinafter “Sharma”).
As to Claim 1, Tojo discloses a medical device (1) in [0040] and Fig. 1, comprising:
a flexible elongate member (7) in [0044] having a proximal end adjacent to (9) in [0044] as shown in Fig. 1, a distal end (7a) in [0046], and a length (7b, 7c) in [0046] therebetween;
a set of one or more positional controls “manipulation wires” in [0048] disposed along the length of the flexible elongate member, each positional control in the set of one or more positional controls configured to adjust at least a portion of the flexible elongate member; and
a set of one or more transducers (8b) in [0057]-[0059] and Figs. 3A-3C with (23) in [0065] and Fig. 4 disposed along the length of the flexible elongate member, at least a portion of the set of one or more transducers configured to generate data indicative of a configuration of the flexible elongate member, wherein at least one positional control in the set of positional controls is configured for operation by circuitry (22) in [0051], [0065], and [0069] shown in Figs. 4 and 9 comprised in a device manager (4) in [0041] based on data indicative of the configuration of the flexible elongate member generated by the set of one or more transducers.
As to Claims 1-7, however Tojo does not specifically disclose that at least a portion of the set of one or more transducers is configured to monitor an environment of at least a portion of the flexible elongate member that comprises an interior of a body lumen. Rivera teaches in the analogous field of endeavor of endoscopy in [0314] wherein at least a portion of the set of one or more transducers “transducers” in [0302] is configured to monitor an environment of at least a portion of the flexible elongate member that comprises an interior of a body lumen. It would have been obvious to one of ordinary skill in the art to provide the medical device and transducers of Tojo with additional transducers as taught by Rivera in order to fulfill the same function with predictable results for monitoring the position of the medical device.
In order to expedite prosecution, Banik is cited as a secondary teaching to evidence the level of ordinary skill in the art. In particular, Banik teaches in the analogous field of endoscopy that positional controls are configured to be operated by circuitry in [0087]-[0092] as desirable functionality by a user via position sensors in [0064] and [0092]. Therefore it would have been obvious to one of ordinary skill in the art to provide the device of Tojo with transducers and control means taught by Rivera and Banik in order to fulfill the same function with predictable results for position monitoring and control of the medical device during normal operation.
However Tojo does not specifically disclose a transducer comprising a rangefinder. Fabro teaches in the analogous field of endoscopy wherein transducers capably visualize structures such that relative positions of the anatomy and orientation of a catheter can be determined in [0195]. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the transducers of Tojo, Rivera, and Banik with rangefinding means as taught by Fabro in order to fulfill the same function of navigation with the body lumen and providing additional visualization (Fabro, [0195]).
However Tojo does not specifically disclose a plurality of balloons. Vrba teaches in the analogous field of endoscopy in [0586] and [0597] wherein one or more positional controls comprising a plurality of independently controllable “independently actuatable” in [0048] balloons or balloon segments “inflatable members” in [0048] and (2025) in [0298] and Fig. 20. Sharma teaches in the analogous field of endoscopy in [0622] where transducers can be positioned on balloons of a balloon catheter in [0574] and Fig. 33 such that voltages are measured and that the balloon can be deflated for removal of the catheter in [0398]-[0399]. It would have been obvious to one of ordinary skill in the art to provide the medical device of Tojo with a plurality of independently controllable balloons or balloon segments as taught by Vrba with transducers and being removable as taught by Sharma in order to fulfill the same function of occlusion as needed with predictable results and estimating a shape and size of body lumen (Sharma, [0575]).
As to Claim 2, Tojo discloses the medical device of claim 1, comprising the device manager, the circuitry of the device manager configured to monitor a position of the flexible elongate member within the body lumen based on the data generated by the set of one or more transducers as described in [0078]-[0082].
As to Claim 3, Tojo discloses the medical device of claim 1, comprising the device manager and a user interface (5, 6) in [0041] and Fig. 1 communicatively coupled to the device manager, the circuitry of the device manager configured to operate at least one positional control in the set of one or more positional controls based on input received via the user interface as described in [0048].
As to Claim 4, Tojo discloses the medical device of claim 1, comprising the device manager and a user interface (5, 6) in [0041] and Fig. 1 communicatively coupled to the device manager, the circuitry of the device manager configured to display the configuration of the flexible elongate member via the user interface as described in [0051] and [0169].
As to Claim 5, Tojo in view of Vrba discloses the medical device of claim 1, wherein Vrba also teaches that one or more portions of the plurality of independently controllable balloons are configured to retract into the flexible elongate member when deflated “deflated” and “retracted” in [0298]. Sharma also teaches that the balloon can be deflated for removal of the catheter in [0398]-[0399] as discussed above.
As to Claim 6, Tojo discloses the medical device of claim 1, comprising the device manager, the circuitry of the device manager configured to determine a suggested position “insertion/removal amount and the rotation amount of the insertion section” in [0117], [0142], and [0168] of at least a portion of the flexible elongate member.
As to Claim 7, Tojo discloses the medical device of claim 6, comprising the device manager and a user interface (5, 6) in [0041] and Fig. 1 communicatively coupled to the device manager, the circuitry of the device manager configured to communicate the suggested position of at least a portion of the flexible elongate member via the user interface as described in [0051] and [0169].
As to Claim 8, Tojo discloses an apparatus (1) in [0040] and Fig. 1, comprising:
a processor (4) in [0041] and Fig. 1; and
memory (0040) in [0051] and Fig. 1 comprising instructions that when executed by the processor cause the processor to:
identify one or more feedback signals “light transmission amount” in [0057] generated by a set of one or more transducers (8b) in [0057]-[0059] and Figs. 3A-3C with (23) in [0065] and Fig. 4 disposed along a length (7b, 7c) in [0046] of a flexible elongate member (7) in [0044];
determine a current configuration as described in [0117], [0142], and [0168] of at least one portion of the flexible elongate member within a body lumen based on one or more portions of the one or more feedback signals generated by the set of one or more transducers;
compare the current configuration of the at least one portion of the flexible elongate member to a target configuration “target shape information” in [0152]-[0153] and [0163]-[0164] of the at least one portion of the flexible elongate member; and
generate one or more control signals “direct manipulation information” in [0103] and [0129]-[0130] to operate at least one positional control in a set of one or more positional controls disposed along the length of the flexible elongate member to adjust the flexible elongate member based on comparison of the current configuration of the at least one portion of the flexible elongate member to the target configuration.
As to Claims 8-14, however Tojo does not specifically disclose that at least a portion of the set of one or more transducers is configured to monitor an environment of at least a portion of the flexible elongate member that comprises an interior of a body lumen. Rivera teaches in the analogous field of endeavor of endoscopy in [0314] wherein at least a portion of the set of one or more transducers “transducers” in [0302] is configured to monitor an environment of at least a portion of the flexible elongate member that comprises an interior of a body lumen. It would have been obvious to one of ordinary skill in the art to provide the medical device and transducers of Tojo with additional transducers as taught by Rivera in order to fulfill the same function with predictable results for monitoring the position of the medical device.
In order to expedite prosecution, Banik is cited as a secondary teaching to evidence the level of ordinary skill in the art. In particular, Banik teaches in the analogous field of endoscopy that positional controls are configured to be operated by circuitry in [0087]-[0092] as desirable functionality by a user via position sensors in [0064] and [0092]. Therefore it would have been obvious to one of ordinary skill in the art to provide the device of Tojo with transducers and control means taught by Rivera and Banik in order to fulfill the same function with predictable results for position monitoring and control of the medical device during normal operation.
However Tojo does not specifically disclose a transducer comprising a rangefinder. Fabro teaches in the analogous field of endoscopy wherein transducers capably visualize structures such that relative positions of the anatomy and orientation of a catheter can be determined in [0195]. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the transducers of Tojo, Rivera, and Banik with rangefinding means as taught by Fabro in order to fulfill the same function of navigation with the body lumen and providing additional visualization (Fabro, [0195]).
However Tojo does not specifically disclose a plurality of balloons. Vrba teaches in the analogous field of endoscopy in [0586] and [0597] wherein one or more positional controls comprising a plurality of independently controllable “independently actuatable” in [0048] balloons or balloon segments “inflatable members” in [0048] and (2025) in [0298] and Fig. 20. Sharma teaches in the analogous field of endoscopy in [0622] where transducers can be positioned on balloons of a balloon catheter in [0574] and Fig. 33 such that voltages are measured and that the balloon can be deflated for removal of the catheter in [0398]-[0399]. It would have been obvious to one of ordinary skill in the art to provide the medical device of Tojo with a plurality of independently controllable balloons or balloon segments as taught by Vrba with transducers and being removable as taught by Sharma in order to fulfill the same function of occlusion as needed with predictable results and estimating a shape and size of body lumen (Sharma, [0575]).
As to Claim 9, Tojo discloses the apparatus of claim 8, the memory comprising instructions that when executed by the processor cause the processor to communicate the target configuration of the at least one portion of the flexible elongate member as described in [0051] and [0169] via a user interface (5, 6) in [0041] and Fig. 1.
As to Claim 10, Tojo discloses the apparatus of claim 8, the memory comprising instructions that when executed by the processor cause the processor to communicate the current configuration of the at least one portion of the flexible elongate member as described in [0051] and [0169] via a user interface (5, 6) in [0041] and Fig. 1.
As to Claim 11, Tojo discloses the apparatus of claim 8, the memory comprising instructions that when executed by the processor cause the processor to determine the environment (configuration) of the at least one portion of the flexible elongate member within the body lumen based on at least one portion of the one or more feedback signals generated by the set of one or more transducers as described in [0152]-[0153] and [0163]-[0164].
As to Claim 12, Tojo discloses the apparatus of claim 8, the memory comprising instructions that when executed by the processor cause the processor to operate at least one positional control in the set of one or more positional controls as described in [0048] based on input received via a user interface (5, 6) in [0041] and Fig. 1.
As to Claim 13, Tojo discloses the apparatus of claim 8, the memory comprising instructions that when executed by the processor cause the processor to determine the target configuration of the at least one portion of the flexible elongate member based on a previous configuration of the at least one portion of the flexible elongate member as described in [0152]-[0153] and [0163]-[0164].
As to Claim 14, Tojo discloses the apparatus of claim 8, the memory comprising instructions that when executed by the processor cause the processor to determine the target configuration of the at least one portion of the flexible elongate member as described in [0152]-[0153] and [0163]-[0164] based on input received via a user interface (5, 6) in [0041] and Fig. 1.
As to Claim 15, Tojo discloses a method, comprising:
identifying one or more feedback signals “light transmission amount” in [0057] generated by a set of one or more transducers (8b) in [0057]-[0059] and Figs. 3A-3C with (23) in [0065] and Fig. 4 disposed along a length (7b, 7c) in [0046] of a flexible elongate member (7) in [0044];
determining a current configuration as described in [0117], [0142], and [0168] of at least one portion of the flexible elongate member within a body lumen based on one or more portions of the one or more feedback signals generated by the set of one or more transducers;
comparing the current configuration of the at least one portion of the flexible elongate member to a target configuration “target shape information” in [0152]-[0153] and [0163]-[0164] of the at least one portion of the flexible elongate member; and
generating one or more control signals “direct manipulation information” in [0103] and [0129]-[0130] to operate at least one positional control in a set of one or more positional controls disposed along the length of the flexible elongate member to adjust the flexible elongate member based on comparison of the current configuration of the at least one portion of the flexible elongate member to the target configuration.
As to Claims 15-22, however Tojo does not specifically disclose that at least a portion of the set of one or more transducers is configured to monitor an environment of at least a portion of the flexible elongate member that comprises an interior of a body lumen of a patient. Rivera teaches in the analogous field of endeavor of endoscopy in [0314] wherein at least a portion of the set of one or more transducers “transducers” in [0302] is configured to monitor an environment of at least a portion of the flexible elongate member that comprises an interior of a body lumen of a patient. It would have been obvious to one of ordinary skill in the art to provide the medical device and transducers of Tojo with additional transducers as taught by Rivera in order to fulfill the same function with predictable results for monitoring the position of the medical device.
In order to expedite prosecution, Banik is cited as a secondary teaching to evidence the level of ordinary skill in the art. In particular, Banik teaches in the analogous field of endoscopy that positional controls are configured to be operated by circuitry in [0087]-[0092] as desirable functionality by a user via position sensors in [0064] and [0092]. Therefore it would have been obvious to one of ordinary skill in the art to provide the device of Tojo with transducers and control means taught by Rivera and Banik in order to fulfill the same function with predictable results for position monitoring and control of the medical device during normal operation.
However Tojo does not specifically disclose a transducer comprising a rangefinder. Fabro teaches in the analogous field of endoscopy wherein transducers capably visualize structures such that relative positions of the anatomy and orientation of a catheter can be determined in [0195]. It would have been obvious to one of ordinary skill in the art at the time of invention to provide the transducers of Tojo, Rivera, and Banik with rangefinding means as taught by Fabro in order to fulfill the same function of navigation with the body lumen and providing additional visualization (Fabro, [0195]).
However Tojo does not specifically disclose a plurality of balloons. Vrba teaches in the analogous field of endoscopy in [0586] and [0597] wherein one or more positional controls comprising a plurality of independently controllable “independently actuatable” in [0048] balloons or balloon segments “inflatable members” in [0048] and (2025) in [0298] and Fig. 20. Sharma teaches in the analogous field of endoscopy in [0622] where transducers can be positioned on balloons of a balloon catheter in [0574] and Fig. 33 such that voltages are measured and that the balloon can be deflated for removal of the catheter in [0398]-[0399]. It would have been obvious to one of ordinary skill in the art to provide the medical device of Tojo with a plurality of independently controllable balloons or balloon segments as taught by Vrba with transducers and being removable as taught by Sharma in order to fulfill the same function of occlusion as needed with predictable results and estimating a shape and size of body lumen (Sharma, [0575]).
As to Claim 16, Tojo discloses the method of claim 15, comprising communicating the target configuration of the at least one portion of the flexible elongate member as described in [0051] and [0169] via a user interface (5, 6) in [0041] and Fig. 1.
As to Claim 17, Tojo discloses the method of claim 15, comprising communicating the current configuration of the at least one portion of the flexible elongate member as described in [0051] and [0169] via a user interface (5, 6) in [0041] and Fig. 1.
As to Claim 18, Tojo discloses the method of claim 15, comprising determining an environment (configuration) of the at least one portion of the flexible elongate member within the body lumen based on at least one portion of the one or more feedback signals generated by the set of one or more transducers as described in [0152]-[0153] and [0163]-[0164].
As to Claim 19, Tojo discloses the method of claim 15, comprising operating at least one positional control in the set of one or more positional controls as described in [0048] based on input received via a user interface (5, 6) in [0041] and Fig. 1.
As to Claim 20, Tojo discloses the method of claim 15, comprising determining the target configuration of the at least one portion of the flexible elongate member based on a previous configuration of the at least one portion of the flexible elongate member as described in [0152]-[0153] and [0163]-[0164].
As to Claim 21, Tojo in view of Vrba discloses the method of claim 15, wherein the body lumen is a duodenum of the patient and wherein after the flexible elongate member is adjusted [based on comparison of the current configuration of the at least one portion of the flexible elongate member to the target configuration] the method further comprises accessing a biliary duct of the patient as described in [0012], [0246], and [0719]-[0720].
As to Claim 22, Tojo in view of Vrba discloses the apparatus of claim 8, wherein Vrba also teaches that one or more portions of the plurality of independently controllable balloons are configured to retract into the flexible elongate member when deflated “deflated” and “retracted” in [0298]. Sharma also teaches that the balloon can be deflated for removal of the catheter in [0398]-[0399] as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See the enclosed 892 form. 20250120649 and 20210196341 are cited to show deflatable removable balloons with transducers
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM B CHOU whose telephone number is (571) 270-3367. The examiner can normally be reached on M-F 9 am - 6 pm.
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, Michael Carey can be reached on (571) 270-7235. 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.
/WILLIAM CHOU/
Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795