DETAILED ACTION
This action is pursuant to the claims filed on 02/03/2026. Claims 1-17 and 38-40 are pending. A first action on the merits of claims 1-17 and 38-40 is as follows.
Response to Arguments
Applicant's arguments filed 02/03/2026 have been fully considered but they are not persuasive. Applicant argues on pages 6-7 of the remarks that Townley fails to teach identifying the avoidance region of tissue along the body lumen wall based on the received data from the at least one characterization sensor. Stating that para. [0042] of Townley fails to “teach or suggest a characterization sensor at all” let alone the above noted limitation.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the rejection of record relies upon the Rajagopalan reference to disclose the characterization sensor as the imaging system and image analysis algorithm disclosed in para. [0215]. Rajagopalan fails to explicitly teach identifying the avoidance region based specifically on the data from characterization sensor with the machine-readable instructions of the processor, and rather discloses in para. [0233] manually identifying an avoidance region. Meanwhile, in related prior art, Townley teaches a similar processor in para. [0042] that is capable of automatically detecting an avoidance region (i.e., non-target tissue). As such, these arguments are unpersuasive.
Applicant’s arguments on pages 7-8 of the remarks allege Townley fails to teach the processor configured to “select a portion of the at least one electrical ablation element to activate based on the marked avoidance region to prevent ablation in the marked avoidance region.” Further stating on page 8 that “while [Townley] mentions … electrodes that are not proximate to the target tissue remain inactive, nowhere does para. [0110] indicate that selecting which electrodes to activate is based on a marked avoidance region”.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the rejection of record relies upon the Rajagopalan reference to disclose the use of a marked avoidance region as disclosed in para. [0233] using a marker 430 to provide a marked avoidance region. As such, these arguments are unpersuasive.
All remaining arguments directed to the remaining claims are equally unpersuasive for the reasons stated above.
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.
Claim(s) 1-4, 6-8, 10, 13-17, and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan (U.S. PGPub No. 2017/0007310) in view of Townley (U.S. PGPub No. 2020/0179040).
Regarding claim 1, Rajagopalan teaches A medical system comprising: at least one characterization sensor for providing data to identify an avoidance region of tissue along a body lumen wall (Fig 1, imaging device 55); an elongate device including a proximal end portion, a distal end portion and at least one electrical ablation element coupled to the distal end portion (Fig 1 [0103] [0155]; catheter 100 with treatment element 139a), a marking system configured to mark the avoidance region (Fig 1 [0233], marker 430 is used to mark non-target tissue); and a control system comprising a processor and a memory including machine readable instructions that, when executed by the processor (Fig 1, processor 250 with algorithm 251); receive the data from the at least one characterization sensor ([0215] disclosing system receiving image data for analysis), identify the avoidance region of tissue along the body lumen wall based on the received data from the at least one characterization sensor (Fig 1 [0233], marker 430 is used to mark non-target tissue), wherein the identified avoidance region is marked by the marking system (Fig 43 [0574-0575]; step 4340), and select a portion of the at least one electrical ablation element to activate based on the marked avoidance region to prevent ablation in the marked avoidance region.
Rajagopalan fails to explicitly teach instructions that, when executed by the processor identify the avoidance region of tissue along the body lumen wall based on the received data from the at least one characterization sensor; wherein the identified avoidance region is marked by the marking system; and select a portion of the at least one electrical ablation element to activate based on the marked avoidance region to prevent ablation in the marked avoidance region.
In related prior art, Townley teaches a control system comprising a processor and a memory including machine readable instructions that, when executed by the processor cause the control system to instructions that, when executed by the processor identify the avoidance region of tissue along the body lumen wall based on the received data from the at least one characterization sensor ([0042]) and select a portion of the at least one electrical ablation element to activate based on the marked avoidance region to prevent ablation in the marked avoidance region ([0110] “electrodes 136 can be activated to target neural fibers in a specific region while the other electrodes 136 remain inactive. In certain embodiments, for example, electrodes 136 may be activated across the portion of the second segment 124 that is adjacent to tissue at the target site, and the electrodes 136 that are not proximate to the target tissue can remain inactive to avoid applying energy to non-target tissue”). 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 control system of Rajagopalan in view of Townley to incorporate the control system for identifying the avoidance region and marking the avoidance region based on said identification; and selecting a portion of the ablation element to activate based on the identified and marked avoidance region to arrive at claim 1. Doing so would advantageously provide the system with the software to avoid the unintended treatment of non-target tissue ([0110]). Furthermore, it has been held that “broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.” In reVenner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958). In the instant case, automating the marking of the avoidance region with a processor, memory, and instructions as claimed would yield the same predictable results as the disclosed manual process of marking an avoidance region ([0233], marker 430 is used to mark non-target tissue). Said predictable result being the avoidance of unwanted ablation of non-target tissue.
Regarding claim 2, Rajagopalan teaches wherein the avoidance region includes a circumferential portion of the tissue along the body lumen wall (Fig 3, device is designed to be inserted into a circumferential tissue lumen; [0017] discloses non-target tissue being the pylorus, which is a circumferential portion of the small intestine).
Regarding claim 3, in view of the combination of claim 1, Rajagopalan teaches wherein the marking system is further configured to mark the tissue in the body lumen wall identified by the at least one characterization sensor ([0550-0551] disclosing imaging device 55 imaging tissue and algorithm 251 identifying position of non-target tissue relative to the functional assembly; such that the marking of the non-target tissue is performed in response to the identified tissue).
Regarding claim 4, Rajagopalan teaches wherein the marking system includes a delivery mechanism for injecting dye or implantable sensors ([0233] disclosing marker 430 as dye or implantable marker).
Regarding claim 6, Rajagopalan teaches wherein the at least one characterization sensor includes an efficacy sensor that provides data to determine effectiveness of the ablation ([0189] functional elements 109, 119, 139, 209, 229 and/or 309 include imaging devices that are analyzed by controller 250 to determine effectiveness of ablation; [0491] further discloses sensor acquiring data to determine effectiveness of ablation).
Regarding claim 7, Rajagopalan teaches wherein the efficacy sensor includes at least one selected from the group of an imaging sensor, a temperature sensor, a current sensor, an impedance sensor, a pH sensor, or a peptide sensor (0189] functional elements 109, 119, 139, 209, 229 and/or 309 include imaging sensors that are analyzed by controller 250 to determine effectiveness of ablation).
Regarding claim 8, Rajagopalan teaches wherein the efficacy sensor is a camera for identifying a change in color of the tissue ([0184] disclosing change in color of tissue can indicate ablation progress; [0189] disclosing functional elements can be imaging devices; [0491] further discloses sensor acquiring data to determine effectiveness of ablation via color change of tissue).
Regarding claim 10, in view of the combination of claim 1, Rajagopalan teaches wherein the at least one characterization sensor configured to detect target cells in the tissue outside of the avoidance region ([0550-0551], imaging device identifies target tissue with processor s described in [0555] and modified with respect to claim 1 above).
Regarding claim 13, in view of the combination of claim 10, Rajagopalan teaches wherein the at least one characterization sensor for detecting the identified target cells includes a peptide sensor for detecting incretin hormones ([0232] tool 500 can detect GLP-1 hormone levels, which are known as incretin hormones, for diagnostic purposes).
Regarding claims 14-15, in view of the combination of claim 10, Rajagopalan teaches wherein the at least one characterization sensor for detecting the target cells includes an imaging sensor (Fig 1 imaging device 55; Fig 41 step 4120-4130 disclosing the imaging sensor used to detect target cells); wherein the imaging sensor is a narrow band imaging sensor, molecular level imaging sensor, confocal imaging sensor, hyperspectral imaging sensor, spectral imaging sensor, or photoacoustic imaging sensor ([0137] disclosing imaging device 55 as at least an ‘imaging sensor’).
Regarding claim 16, in view of the combination of claim 1, Rajagopalan teaches wherein the avoidance region includes sensitive anatomy along the body lumen wall ([0017] non-target tissue is ampulla of Vater, pylorus, and tissues surrounding both; examiner notes these regions include sensitive anatomy one would not want to ablate).
Townley further teaches wherein the at least one characterization sensor includes a biosensor and receiving the data from the at least one characterization sensor includes receiving biosensor data from the biosensor (Fig 1A [0157-0158], algorithms 110 include using sensed resistance, impedance, and/or other properties to map tissue to determine target and non target sites; [0160] also discloses using individual electrodes for mapping purposes) and wherein the control system further: determines a sensitive anatomy along the body lumen wall from the biosensor data, wherein the avoidance region includes sensitive anatomy along the body lumen wall ([0110] “electrodes 136 can be activated to target neural fibers in a specific region while the other electrodes 136 remain inactive. In certain embodiments, for example, electrodes 136 may be activated across the portion of the second segment 124 that is adjacent to tissue at the target site, and the electrodes 136 that are not proximate to the target tissue can remain inactive to avoid applying energy to non-target tissue”; system determines non-target tissue (i.e., sensitive anatomy) based on biosensor data and avoids said non-target tissue). 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 further modified Rajagopalan in view of Townley to incorporate a biosensor as part of the characterization sensor to identify the avoidance regions to arrive at claim 16. Doing so would have been obvious to one of ordinary as the use of biosensors for mapping and identifying tissue is well-known in the art to yield predictable results therein ([0157-0158, 0160]).
Regarding claim 17, in view of the combination of claim 1, Rajagopalan teaches wherein the body lumen wall surrounds a body lumen, the medical system further comprising: an instrument manipulator for positioning the elongate device within the body lumen (Fig 1 system has manipulator for positioning the catheter within the body lumen).
Regarding claim 38, in view of the combination of claim 1, Rajagopalan teaches wherein the at least one electrical ablation element includes a plurality of electrodes configured to selectively energize portions of the tissue ([0206] disclosing RF treatment element 139a comprises an array of electrodes) while preventing energization of the avoidance region (combination of claim 1 makes obvious the processor preventing the energization of the avoidance region).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Townley, and Saadat (U.S. PGPub No. 2005/0203489).
Regarding claim 5, Rajagopalan teaches the device of claim 1 as stated above.
Rajagopalan fails to teach wherein the marking system includes the at least one ablation element, and wherein the at least one ablation element delivers a first amount of energy for ablating the tissue and a second amount of energy for marking the tissue.
In related prior art, Saadat teaches a similar system wherein the marking system includes the at least one ablation element, and wherein the at least one ablation element delivers a first amount of energy for ablating the tissue and a second amount of energy for marking the tissue ([0072] [0076] [0096] and Fig 2C, 12). 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 at least one ablation element and marker of Rajagopalan in view of Saadat to incorporate the use the ablation element as a marker to arrive at the system of claim 5. Doing so would advantageously allow for the ablation element to function as a marker for marking tissue by applying a second amount of energy and as an ablation element by applying another amount of energy ([0072] [0076] [0096]).
Claim(s) 9 and 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Townley, and Wong (U.S. PGPub No. 2019/0298451).
Regarding claim 9, in view of the combination of claim 1, Rajagopalan teaches a display ([0136] system has display for showing camera view); wherein the machine readable instructions, when executed by the processor, further cause the control system to create a map of the body lumen wall; determine a location of the a plurality of target cells within the body lumen wall; and display, on the display, the map including at least one indicator of the target cells at the location.
Rajagopalan fails to teach wherein the machine readable instructions, when executed by the processor, further cause the control system to create a map of the body lumen wall; determine a location of the a plurality of target cells within the body lumen wall; and display, on the display, the map including at least one indicator of the target cells at the location.
In related prior art, Wong teaches a similar system having a display (Fig 3 step 340 discloses a display); wherein the machine readable instructions, when executed by the processor, further cause the control system to create a map of the body lumen wall (Fig 3, step 320 and [0035]); determine a location of the a plurality of target cells within the body lumen wall (Fig 3 step 330 [0038], [0058] disclosing system can determine target areas based on ultrasound and localization sensors to detect hyperplastic tissue); and display, on the display, the map including at least one indicator of the target cells at the location (Fig 3 step 340 [0041]). 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 system of Rajagopalan in view of Wong to incorporate the processor creating a map of the body lumen wall, determining a location of target cells, and displaying the map with an indicator for target cells to arrive at claim 9. Doing so would advantageously allow a user to visualize the treatment area on a display before, during, and/or after a procedure to provide improved medical outcomes.
Regarding claims 11-12, in view of the combination of claim 10 above.
Rajagopalan fails to teach wherein the at least one characterization sensor includes a depth sensor for determining a depth of the identified target cells within the a plurality of layers of the tissue; wherein the depth sensor includes an OCT sensor or an ultrasound sensor.
Wong further teaches wherein the at least one characterization sensor includes a depth sensor for determining a depth of the identified target cells within the a plurality of layers of the tissue ([0058] ultrasound sensor determines depth of hyperplastic (i.e. target) tissue); wherein the depth sensor includes an OCT sensor or an ultrasound sensor ([0058] depth is determined via ultrasound). 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 system of Rajagopalan in view of Wong to incorporate an ultrasound depth sensor to determine a depth of target cells to arrive at claims 11-12. Doing so would advantageously enable the system to determine a depth of target tissue to accurately define a treatment depth parameter for ablation ([0058-0060]; Rajagopalan disclosing controlling depth of ablation in [0145, 0187]).
Claim(s) 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Townley, and Ibrahim (U.S. PGPub No. 2019/0159835).
Regarding claim 39, Rajagopalan/Townley teaches the device of claim 38 as stated above wherein the system prevents energization of non-target tissue (Fig 43 [0574-0575]; steps 4330-4340; Townley [0110]).
Rajagopalan fails to teach wherein preventing energization of the avoidance region includes restricting a rotation of the plurality of electrodes.
In related prior art, Ibrahim teaches a similar system wherein preventing energization of the avoidance region includes restricting a rotation of the plurality of electrodes ([0019] controller restricts rotation of elongate device to prevent energization of non-target tissue). 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 system of Rajagopalan in view of Ibrahim to incorporate the restriction of rotation of the electrodes to prevent energization of the avoidance region to arrive at the system of claim 39. Doing so would advantageously incorporate a further means to prevent the inadvertent and unintended ablation of non-target tissue to yield better medical outcomes for patients by holding the treatment device in place rotationally during ablation (Ibrahim [0019-0020]; Rajagopalan Fig 43 [0574-0575]; steps 4330-4340 disclosing the preventing energization of non-target tissue).
Claim(s) 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rajagopalan in view of Townley and Howard (U.S. PGPub No. 2021/0145365).
Regarding claim 40, Rajagopalan/Townley teaches the device of claim 1 as stated above.
Rajagopalan fails to teach wherein controlling control activation of the electrical ablation element includes providing a user notification when the distal end portion of the elongate device is at or near the avoidance region.
In related prior art, Howard teaches a similar system (Fig 1) wherein controlling control activation of the electrical ablation element includes providing a user notification when the distal end portion of the elongate device is at or near the avoidance region ([0067] alert is provided to a user if the deice is pressed against non-target tissue using visualizations of an imaging system). 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 system of Rajagopalan in view of Howard to incorporate the providing of a user alert when the distal end of the device is at or near the avoidance region to arrive at the system of claim 40. Doing so would advantageously work to prevent the inadvertent treatment of non-target tissue to provide better medical outcomes ([0067]).
Conclusion
THIS ACTION IS MADE FINAL. 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 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