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 .
Response to Amendment
Claims filed on March 2nd, 2026 have been entered. Claims 2- 11 are pending in the application. The amendment to claim 2 and claims 5 and 8 overcome the previous claim objections and the 35 U.S.C. 112(b) rejection.
Drawings
Applicant’s arguments regarding the drawing objections has been fully considered and are persuasive. The previous drawing objections have been withdrawn.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.
Claim(s) 2, 5 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 2005/0203553) in view of Stigall (US 2014/0275996).
Regarding claim 2, Maschke ‘553 teaches a catheter system (Fig. 1)(abstract), comprising: a catheter (OCT-rotablation catheter shown in Fig. 1) having an optical coherence tomography (OCT) imaging sensor (4) attached thereto configured to gather OCT images (Paragraph 0022); and a controller (The controller is interpreted as a part of the user interface that controls the system, as set forth in Paragraph 0026).
Maschke ‘553 does not teach the controller configured to automatically identify an external elastic lamina in the OCT images.
Stigall teaches an imaging system (Figs. 5a- 5b) for use in an atherectomy procedure (abstract) that identifies an EEL in images (Paragraph 0040).
It would have been obvious to modify the controller as taught by Maschke ‘553 to have the ability to identify an EEL through an image as taught by Stigall, as Maschke ‘553 teaches that the device is able to provide information on the vascular wall, which an EEL is a part of (Maschke ‘553, Paragraph 0015), Stigall teaches the identification system being in use with an atherectomy device and an imaging device (Stigall, abstract and Paragraph 0040) and one of ordinary skill in the art would recognize that identifying the tissue that requires operation allows for the operator to confirm where the device is located and perform an operation.
The combination does not teach the identification as automatic.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to automate the identification of the external elastic lamina in the OCT images, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routing skill in the art. In re Venner, 120 USPQ 192.
Regarding claim 5, Maschke ‘553 and Stigall teaches the catheter system as discussed above.
Regarding wherein the controller is further configured to adjust a depth of cut based upon the identification of the external elastic lamina in the OCT images, as this language is functional, the controller only has to be able to complete the function. Since Maschke ‘553 teaches that the user interface controls the system in Paragraph 0026, and the combination of Maschke ‘553 and Stigall automatically identifies the external elastic lamina (see claim 2 above), when it is identified, a user and therefore the controller being modified by the user, would be able to adjust the depth of cut based upon the information given.
Regarding claim 8, Maschke ‘553 and Stigall teaches the catheter system as discussed above.
Regarding wherein the controller is further configured to reorient a distal tip of the catheter based upon the identification of the external elastic lamina in the OCT images, as this language is functional, the controller only has to be able to complete the function. Since Maschke ‘553 teaches that the user interface controls the system in Paragraph 0026, and the combination of Maschke ‘553 and Stigall automatically identifies the external elastic lamina (see claim 2 above), when it is identified, a user and therefore the controller being modified by the user, would be able to reorient the distal tip of the catheter based on the identification of the external elastic lamina.
Claim(s) 3- 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 2005/0203553) in view of Stigall (US 2014/0275996), as applied to claim 2 above, in further view of Spencer et al. (US 2011/0021926).
Regarding claim 3, Maschke ‘553 and Stigall make obvious the catheter system as discussed above.
Maschke ‘553 further teaches a display connected to the controller (The display is the visualization unit set forth in Paragraph 0026).
The combination does not teach wherein the display is configured to display the OCT images as a toroidal view of the vessel.
Spencer (Spencer et al.) teaches imaging a body lumen through OCT using a catheter (abstract), and displaying the OCT images as a toroidal view of the vessel (Paragraphs 0042 and 0085).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the display as taught by the combination to display the OCT images as a toroidal view of the vessel, as that is a well-known display method of the images of an OCT device, as shown by Spencer (Paragraph 0042).
Regarding claim 4, Maschke ‘553 and Stigall make obvious the catheter system as discussed above.
Maschke ‘553 does not teach wherein the controller is further configured to highlight the external elastic lamina in the OCT images on the display.
Stigall teaches an imaging system (Figs. 5a- 5b) for use in an atherectomy procedure (abstract) that identifies an EEL in images, wherein the EEL is highlighted on the display (Paragraph 0040).
It would have been obvious to modify the controller as taught by the combination to have the ability to highlight the EEL on the display as taught by Stigall, as Maschke ‘553 teaches that the device is able to provide information on the vascular wall, which an EEL is a part of (Maschke ‘553, Paragraph 0015), Stigall teaches the identification system being in use with an atherectomy device and an imaging device (Stigall, abstract and Paragraph 0040) and one of ordinary skill in the art would recognize that highlighting the EEL allows for clear identification between the EEL and a plaque to be removed.
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 2005/0203553) in view of Stigall (US 2014/0275996), as applied to claim 6 above, in further view of Maschke (US 2005/0187571) and in view of Mokelke et al. (US 2011/0040344).
Regarding claims 6 and 7, Maschke ‘553 and Stigall teaches the catheter system as discussed above.
The combination does not teach (claim 6) wherein the controller is configured to move a cutter of the catheter from an active mode to a passive mode to adjust the depth of cut or (claim 7) wherein the catheter further includes a balloon configured to inflate or deflate to expose or cover the cutter, and wherein the controller is configured to at least partially deflate the balloon to move the cutter from the active mode to the passive mode.
Maschke ‘571 teaches a similar catheter system (abstract)(Figs. 1- 3) comprising a catheter (1), an OCT sensor (3) disposed in the catheter (Paragraph 0022), a cutter (rotating knife 4) and a balloon (8) configured to inflate and cover the cutter with tissue (Paragraph 0023) and then deflate to expose the cutter to the blood of the vessel (When the balloon is deflated, the cutter would not be pressed into the tissue and therefore would be exposed to the blood of the vessel.).
It would have been obvious to modify the catheter as taught by Maschke ‘553 to have a balloon as taught by Maschke ‘571 since both Maschke ‘553 and Maschke ‘571 teach cutters for removing tissue (Maschke ‘553, abstract and Paragraph 0022; Maschke ‘571, abstract and Paragraph 0023) and Maschke ‘571 teaches that the balloon aids in the removal of tissue (Paragraph 0023).
The combination does not teach (claim 6) wherein the controller is configured to move a cutter of the catheter from an active mode to a passive mode to adjust the depth of cut or (claim 7) wherein the controller is configured to at least partially deflate the balloon to move the cutter from the active mode to the passive mode.
Mokelke (Mokelke et al.) teaches a system for treating an issue within the body (abstract) comprising a controller that controls the operation of a balloon (Paragraph 0067).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the controller as taught by the combination to control the operation of the balloon as taught by Mokelke, as Maschke ‘553 teaches that the controller operates the device (Maschke ‘553, Paragraph 0026), and the balloon of the combination is a part of the device.
Regarding wherein the controller is configured to move a cutter of the catheter from an active mode to a passive mode to adjust the depth of cut, as Maschke ‘571 teaches that the balloon presses tissue into the cutter (Paragraph 0023), when the controller inflates the balloon, then the cutter would be moved into an active mode able to cut the tissue, and when the controller deflates the balloon, the cutter would be moved into a passive mode with the depth of cut reduced to zero as the cutter is no longer present.
Claim(s) 9- 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Maschke (US 2005/0203553) in view of Stigall (US 2014/0275996), as applied to claim 2 above, in further view of Dasilva (US 6,451,009).
Regarding claims 9- 11, Maschke ‘553 teaches the catheter system as discussed above.
The combination does not teach (claim 9) wherein the controller is further configured to determine a distance between a cutter of the catheter and the external elastic lamina, (claim 10) wherein the controller is configured to activate an alarm if the distance is below a threshold value, or (claim 11) wherein the controller is configured to prevent cutting if the distance is below a threshold value.
Dasilva teaches a system (40)(Fig. 2) for treating tissue (abstract, Column 3, Lines 56- 57), the system comprising having imaging device (OCDR 51), an ablation tool (55), and a controller (control unit 50) configured to identify tissue, and to determine a distance between the ablation tool and the tissue, wherein the controller is configured to activate an alarm if the distance is below a threshold value and is configured to prevent cutting if the distance is below a threshold value (Column 3, Lines 10- 14; 48- 57).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the controller as taught by the combination to be able to determine a distance between a cutter and the external elastic lamina, to activate an alarm if the distance is below a threshold, and to prevent cutting if the distance is below a threshold value, since Maschke ‘553 teaches that the OCT imaging system can be upgraded to allow quantification , such as length and surface of the stenosis, and the distance between the cutter and the external elastic lamina would be a known quantity, and the controller can use these quantities (Paragraphs 0026 and 0027), and Davila teaches that the alarm and prevention of cutting prevents damage to sensitive tissue (abstract, Column 3, Lines 10- 14).
Response to Arguments
Applicant's arguments filed March 2nd, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments, see Pages 8 and 10, regarding that the prior art does not disclose all of the claim limitations as Stigall does not disclose any ability to identify an EEL through an optical coherence tomograph (OCT) image, have been fully considered but are not persuasive. The reference of Stigall is used to teach what target is identified by the OCT sensor of Maschke, it is not used to teach the sensor or the type of imaging. As Maschke teaches that the OCT sensor provides “important additional medical information about the plaque and the vascular wall, e.g. inflammatory processes” (Paragraph 0015), which includes inflammatory processes as an example and not the only information capable of being obtained about the vascular wall as applicant argues on Page 9, then with the teaching of Stigall the target that is imaged by OCT in Maschke is modified to be the EEL, which is a part of the vascular wall. Therefore, the combination teaches identifying the EEL through an OCT sensor.
Applicant’s arguments, see Pages 9- 10, regarding that it would not have been obvious to modify the system to automatically identify the EEL, has been fully considered but is not persuasive. As Maschke teaches that the system includes a user interface which controls the system and operates the visualization for the OCT imaging (Paragraph 0026), then the manual activity is the identification of tissue by a user through the user interface. Therefore, within the combination, the manual activity that is being automated is the identification of the EEL through the OCT sensor.
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 LINDSEY R. RIVERS whose telephone number is (571)272-0251. The examiner can normally be reached Monday- Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at (571) 272- 4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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