DETAILED ACTION
This action is pursuant to the claims filed on 08/17/2022. Claims 18-37 are pending. A first action on the merits of claims 18-37 is as follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/20/2025, 06/20/2025, 03/21/2023, 09/12/2022, 08/30/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 18-21, 23, 25-27, 30-31, 33-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (U.S. PGPub No. 2017/007310) in view of Strommer (U.S. PGPub No. 2005/0197566).
Regarding claim 18, Rajagopalan teaches A medical system for positioning a medical device within a body lumen, the medical system comprising: the medical device comprising a distal end portion, an expandable member (Fig 25A-C, distal end at 115 and multiple expandable members 130); at least one alignment sensor ([0182] pressure sensors used with functional assemblies 130; [0215] also discloses image sensors that function as alignment sensors); and a control system operably coupled to the medical device and the at least one alignment sensor, wherein the control system comprises a processing system and a memory system operatively coupled to the processing system, the memory system including programmed instructions adapted to cause the processing system to perform operations ([0162] console 200, settings 201, controller 250, processor 252, algorithm 251 defined control system with programmed instructions therein) comprising: detecting, via the at least one alignment sensor, alignment of the distal end portion of the medical device with an anatomic structure ([0215]); expanding the expandable member to contact a wall of the body lumen to align the distal end portion of the medical device with a longitudinal centerline of the body lumen ([0162] and Fig 25 “one or more console settings 201 comprise a setting related to a system 10 parameter selected from the group consisting of: pressure and/or volume of a fluid delivered to and/or extracted from functional assembly 130 for inflation and/or deflation (e.g. to obtain apposition of ports 137 and/or to anchor functional assembly 130 in the intestine)”).
Rajagopalan fails to teach advancing the medical device a total insertion distance via the programmed instructions and processing system.
In related prior art, Strommer teaches a similar device wherein a similar processing system includes instructions for advancing the medical device a total insertion distance ([0043]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rajagopalan in view of Strommer to incorporate the instructions for the processor to advance the medical device a total insertion distance to arrive at claim 18. Doing so would advantageously enable the processing system to monitor and track advancement of the medical device to detect blockages to avoid unintentional harm to a patient ([0043]).
Regarding claims 19 and 33, in view of the combination of claim 18 above, an alternative embodiment of Rajagopalan teaches a rigidizing system, wherein the control system is further operatively coupled to the rigidizing system (Fig 18 [0430-0432] anchors 144a and 144b, and vacuum ports 137 all function to rigidize the distal end of the device to prevent movement), and wherein the operations further comprise: rigidizing the distal end portion of the medical device using the rigidizing system (Fig 18 and [0430-0432] anchors 144a-b are deployed with the expansion of the functional member 130 which is disclosed as part of the processor operations in [0162]); wherein the distal end portion of the medical device being rigidized is near the expandable member (Fig 18 anchors 144a-b rigidize the distal end portion of the medical device included the portion near expandable member 130). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the embodiment of Fig 25 of Rajagopalan in view of Fig 18 to incorporate the rigidizing system to arrive at claims 19 and 33. Doing so would advantageously anchor the functional assemblies 130 at a location within the patient’s anatomy to prevent unintended movement of the medical device ([0430-0432]).
Regarding claim 20, in view of the combination of claim 19 above, Rajagopalan further teaches wherein the operations further comprise collapsing the expandable member after rigidizing the distal end portion of the medical device (Figs 3, 18 and 25, functional members 130 are collapsed after rigidizing to remove the medical device from the patient after the operation is completed).
Regarding claim 21, in view of the combination of claim 18 above, Strommer teaches wherein advancing the medical device includes inserting a fixed distance, the fixed distance being an incremental distance of the total insertion distance ([0043]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rajagopalan in view of Strommer to incorporate the instructions for the processor to advance the medical device an incremental distance of the total insertion distance to arrive at claim 21. Doing so would advantageously enable the processing system to monitor and track advancement of the medical device to detect blockages to avoid unintentional harm to a patient ([0043]).
Regarding claim 23, in view of the combination of claim 18 above, Rajagopalan teaches wherein the at least one alignment sensor includes at least one navigation sensor configured to detect at least one of a proximity of the distal end portion of the medical device to the anatomic structure, a force between the medical device and the anatomic structure ([0248]), or a misalignment with a desired orientation along a desired path within the body lumen.
Regarding claim 25, in view of the combination of claim 18 above, Rajagopalan teaches wherein the at least one alignment sensor includes at least one imaging sensor configured to detect a proximity of the distal end portion of the medical device to the anatomic structure ([0215] image sensor detects apposition of assembly 130 on distal end portion of the medical device with the anatomic structure).
Regarding claim 26, in view of the combination of claim 25 above, Rajagopalan teaches wherein the imaging sensor comprises an endoscopic camera, an ultrasound device, a fiberscope, or an optical coherence tomography device ([0137]).
Regarding claim 27, in view of the combination of claim 18 above, Rajagopalan teaches wherein the anatomic structure is the body lumen and the at least one alignment sensor is configured to detect a fluid meniscus to determine a proximity of the distal end portion of the medical device to the body lumen ([0215] image sensor detects apposition of assembly 130 on distal end portion of the medical device with the anatomic structure being a body lumen; image sensor and medical device is capable of detecting a fluid meniscus of the body lumen).
Regarding claim 30, in view of the combination of claim 18 above, Rajagopalan teaches wherein the anatomic structure is a body sphincter (see Fig 3) and the at least one alignment sensor include a pressure sensor for detecting a pressure gradient across the body sphincter ([0248] [0182] pressure sensor measures pressure of the level of apposition with the intestine and muscular contraction of the intestine).
Regarding claim 31, in view of the combination of claim 30 above, Rajagopalan teaches wherein the advancing of the medical device includes inserting the distal end portion of the medical device towards a direction of the pressure gradient (see Fig 3, medical device is advanced towards a direction of the pressure gradient).
Regarding claim 34, in view of the combination of claim 18 above, Rajagopalan teaches wherein the medical device further comprises at least one ablation element for ablation of the wall of the body lumen ([0476] functional assemblies 130 are configured to perform ablation procedure).
Regarding claim 35, in view of the combination of claim 18 above, Rajagopalan teaches a steering mechanism coupled to the control system ([0276] disclosing controls 104, 24, 34, 44 in the form of a user interface to allow operator to steer distal portion of shaft), wherein the operations further comprises positioning the distal end portion of the medical device within the body lumen to align the distal end portion with the anatomic structure (see Fig 25, distal end portion is aligned with anatomical structure within body lumen; user interface disclosed in [0276] requires instructions within the controller to actuate the inputted operation).
Regarding claim 36, in view of the combination of claim 18 above, Rajagopalan teaches a medical device comprising a user input device coupled to the control system for advancing the catheter the total insertion distance ([0276]).
Rajagopalan fails to teach wherein the total insertion distance is based on input provided through the user input device.
Strommer further teaches a user input device coupled to the control system, wherein the total insertion distance is based on input provided through the user input device (Fig 1 [0028-0029], user indicates the origin 136 and destination 138 of the medical device (i.e., a total insertion distance)). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rajagopalan in view of Strommer to incorporate the instructions for the processor to advance the medical device a total insertion distance based on a user input to arrive at claim 36. Doing so would advantageously enable the processing system to monitor and track advancement of the medical device to detect blockages to avoid unintentional harm to a patient ([0043]).
Regarding claim 37, in view of the combination of claim 18 above, Strommer teaches a user interface for providing user guidance based on the detecting of a misalignment of the medical device with the anatomic structure, wherein the user guidance is at least one of visual, audible, or haptic guidance ([0050] visual feedback of automatic advancement of the catheter can provide user guidance (i.e., manual control takeover with guidance from visual feedback) based on detection of misalignment as disclosed in [0043] at more intricate portions of path 128). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rajagopalan in view of Strommer to incorporate the user interface for providing user guidance based on the detecting of a misalignment to arrive at claim 37. Doing so would advantageously provide an operator with user guidance in the form of a visual feedback interface to enable manual control of the medical device in more intricate portions of the anatomy ([0050]).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Strommer, and in further view of Howard (U.S. PGPub No. 2021/0145365).
Regarding claim 24, the Rajagopalan/Strommer combination teaches the device of claim 23.
Rajagopalan is silent to the type of navigation sensor.
In related prior art, Howard teaches a similar navigation sensor comprises a capacitive strain gauge, a fiber bragg sensor (Figs 2-8, fiber bragg grating sensor 36 for pressure and force sensing), a semiconductor, an electromagnetic sensor, a gravity sensor, an acoustic sensor, or an accelerometer. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Rajagopalan in view of Howard to incorporate the fiber bragg sensor to arrive at claim 24. Doing so would be obvious to one of ordinary skill in the art as fiber bragg sensors are well-known in the art as a type of force sensor used in medical devices for monitoring said forces as needed ([0048]).
Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Strommer, and in further view of Brister (U.S. PGPub No. 2015/0374525).
Regarding claims 28-29, in view of the combination of claim 18 above.
Rajagopalan further teaches wherein the anatomic structure is a body sphincter (see Fig 3, the anatomy is a sphincter); wherein the advancing of the medical device includes inserting the distal end portion of the medical device towards a direction of the pH gradient (Fig 3 insertion of medical device is towards a pH gradient in the same manner as applicant’s instant invention).
Rajagopalan fails to teach the at least one alignment sensor include a pH sensor for detecting a pH gradient across the body sphincter.
In related prior art, Brister teaches a similar device wherein at least one alignment sensor include a pH sensor for detecting a pH gradient across the body sphincter ([0159] a pH sensor can function as an alignment sensor for identifying location based on expected pH values of the anatomy). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the alignment sensor of Rajagopalan in view of Strommer and Brister to incorporate the pH sensor for detecting a pH gradient across the body sphincter to arrive at claims 28-29. Doing so would advantageously enable the alignment sensor to detect pH values of the anatomy to determine the location within the anatomy ([0159]).
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Strommer, and in further view of Nollert (U.S. PGPub No. 2021/0000520).
Regarding claim 32, the Rajagopalan/Strommer combination teaches the device of claim 18 as stated above. Rajagopalan further teaches wherein the expandable member comprises at least one balloon (see Fig 25, functional members 130 are balloons [0471])
Rajagopalan fails to teach wherein the expanding of the balloon is automatically triggered based on detecting a misalignment of the medical device with the anatomic structure.
In related prior art, Nollert teaches a similar device wherein expanding of the balloon is triggered to automatically align the medical device with the anatomic structure ([0021] balloon automatically aligns with anatomy upon inflation to create a known orientation relative to the stomach). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the balloons of Rajagopalan in view of Strommer and Nollert to incorporate the step of automatically triggering the expansion of the balloon to align the medical device with the body lumen when misalignment is detected to arrive at claim 32. Doing so would advantageously provide a balloon shape that yields a known orientation relative to the anatomic structure when inflated ([0021]).
Allowable Subject Matter
Claim 22 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 22, the Rajagopalan, Strommer, Brister, Howard, and Nollert references fail to teach the system of claim 22 including the operations comprising relaxing the distal end portion of the medical device after the medical device is inserted the fixed distance; and after relaxing the distal end portion, repeating the detecting of the alignment of the distal end portion of the medical device with the anatomic structure, the expanding of the expandable member, and the advancing of the medical device the incremental distance until the medical device has advanced the total insertion distance. The Strommer reference discloses moving the medical device a fixed distance that is an incremental distance of the total insertion distance to reiteratively check for blockages or obstacles. However, Strommer fails to teach the repeated relaxing and expanding of the distal end portion and expandable member respectively between each incremental advancment. The other prior art of record fail to cure this deficiency. No other pertinent prior art reference were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claim(s) 22.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adam Z Minchella whose telephone number is (571)272-8644. The examiner can normally be reached M-Fri 7-3 EST.
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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