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 .
Status of Claims
Claims 1 and 3-36 are pending, claims 3, 6-7, and 15-32 have been withdrawn from consideration, claim 2 has been cancelled, and claims 1, 4-5, 8-14, and 33-36 are currently under consideration for patentability under 37 CFR 1.104.
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that “Ransbury, Tearney ‘506, and Gjorsvik…fail to teach an inflatable balloon being configured to inflate to position a light source a predetermined distanced from an inner surface of the inflatable balloon” (on pg. 9 of Remarks), the Examiner respectfully disagrees. Ransbury discloses an inflatable balloon (101, figure 1) being configured to inflate to position a light source (light source is housed inside the balloon [0047]) a predetermined distanced from an inner surface of the inflatable balloon (light source…move independently…retracts from a fully extended position; inflation of the balloon without support assembly can achieve the same result [0047] | see 150, figure 9a). Specifically, Ransbury teaches an inner tube (108, figure 1) that may move independently from a support assembly (103, figure 1) of the balloon (101, figure 1) and may move the optical components further from the target tissue (or through inflation of the balloon) ([0047]).
Regarding Applicant’s argument that “Applicant submits that a minimum distance, as taught by Gjorsvik, is not a predetermined distance, as called for by the claim 1…is not contemplated or possible with the systems in the art of record and, particularly, Gjorsvik” (on pg. 9-10 of Remarks), the Examiner respectfully disagrees. 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).
As discussed above, Ransbury discloses an inflatable balloon (101, figure 1) being configured to inflate to position a light source (light source is housed inside the balloon [0047]) a predetermined distanced from an inner surface of the inflatable balloon (light source…move independently…retracts from a fully extended position; inflation of the balloon without support assembly can achieve the same result [0047] | see 150, figure 9a). Gjorsvik teaches a catheter device (see figure 1) with a catheter body (12, figure 1) and a distal end (10, figure 1). The distal end includes a balloon (18, figure 1) and a foley balloon (20, figure 1). The distal end includes a light source or light emitting elements for providing illumination for the required PDT or photodynamic treatment ([0093]). A central part (22, figure 2) of the array of light emitting elements is within the expansion and positioning balloon ([0093]). The expansion and positioning balloon provides for a minimum distance between the light emitting elements and the bladder wall ([0047]). There can be automatic control of the light dose that relates to the minimum distance of the body tissue from the light emitting element ([0047]). A controller (68, figure 2) controls/starts the array of light emitting elements, providing light for the required period of time to provide a required light dose ([0112]).
The visualization system (120, figures 9a-b) of Ransbury is modified with the controller (68, figure 2) of Gjorsvik, as doing so would provide a controller to control/start the light and to provide light for the required period of time to provide a required light dose for PDT ([0112]; Gjorsvik). The modified device would have a control unit (68, figure 2; Gjorsvik) configured to receive one or more treatment parameters (required period of time [0112]; Gjorsvik) for treating the lesion within the subject and control the light source configured to selectively apply the light to the lesion within the subject based on the one or more treatment parameters (required period of time to provide a required light dose [0112]). Specifically, Gjorsvik teaches automatic control of the light dose that relates to the distance between the body tissue from the light emitting elements, which is determined by the distance between the light emitting elements and the outer surface of the balloon ([0047]).
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) 1, 4-5, 8, 10, and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Ransbury (US 2016/0143522), in view of Tearney (US 2012/0004506) and Gjorsvik (US 2018/0369603).
Regarding claim 1, Ransbury discloses an endoscopic device for treating a lesion within a subject, the endoscopic device comprising: a catheter (100, figure 1), the catheter comprising: a sheath (104, figure 1) having a lumen (one or more lumens [0027]); an inflatable balloon (101, figure 1) configured to be inflated through the lumen of the sheath (movable…inflated state [0031]); and a light source (light source is housed inside the balloon [0047]) controllable through the lumen of the sheath to selectively apply light to the lesion within the subject (light source…move independently…[0047]); wherein the inflatable balloon is configured to inflate to position the light source a predetermined distance from an inner surface of the inflatable balloon when the light source is passed through the lumen of the sheath, into the inflatable balloon (light source…move independently…retracts from a fully extended position; inflation of the balloon without support assembly can achieve the same result [0047]; Ransbury | see 150, figure 9a). Ransbury is silent regarding an endoscope configured to be inserted into the subject, the endoscope including a working channel; the catheter configured to pass through the working channel of the endoscope, and a control unit configured to receive one or more treatment parameters for treating the lesion within the subject and control the light source configured to selectively apply the light to the lesion within the subject based on the one or more treatment parameters.
Tearney teaches the use of a balloon catheter to assess and diagnose diseases arising from luminal organs ([0002] and [0004]). The balloon catheter can be used as a standalone device or with the endoscope through the accessory channel ([0004]).
Gjorsvik teaches a catheter device (see figure 1) with a catheter body (12, figure 1) and a distal end (10, figure 1). The distal end includes a balloon (18, figure 1) and a foley balloon (20, figure 1). The distal end includes a light source or light emitting elements for providing illumination for the required PDT or photodynamic treatment ([0093]). A central part (22, figure 2) of the array of light emitting elements is within the expansion and positioning balloon ([0093], 18, figure 2). The expansion and positioning balloon provides for a minimum distance between the light emitting elements and the bladder wall ([0047]). There can be automatic control of the light dose that relates to the minimum distance of the body tissue from the light emitting element ([0047]). A controller (68, figure 2) controls/starts the array of light emitting elements, providing light for the required period of time to provide a required light dose ([0112]).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the endoscope device/catheter of Ransbury to be used with an endoscope as taught by Tearney ([0004]). Doing so would allow the catheter to be delivered through the accessory channel of the endoscope to the target area ([0004]). Additionally, it would have been obvious to modify the device, specifically the visualization system (120, figures 9a-b), of Ransbury with the controller (68, figure 2) of Gjorsvik. Doing so would provide a controller to control/start the light and to provide light for the required period of time to provide a required light dose for PDT ([0112]; Gjorsvik). The modified device would have an endoscope configured to be inserted into the subject (endoscope [0004]; Tearney), the endoscope including a working channel (accessory channel [0004]); the catheter configured to pass through the working channel of the endoscope (with the endoscope…[0004]), and a control unit (68, figure 2; Gjorsvik) configured to receive one or more treatment parameters (required period of time [0112]; Gjorsvik) for treating the lesion within the subject and control the light source configured to selectively apply the light to the lesion within the subject based on the one or more treatment parameters (required period of time to provide a required light dose [0112]).
Regarding claim 4, Ransbury further discloses the light source includes one of a fiber optic cable (optical fiber to deliver light to the balloon [0042]) extending through the lumen to emit light within the inflatable balloon or a light emitting diode (LED) arranged in the inflatable balloon (LED [0048]; Ransbury).
Regarding claim 5, Ransbury further discloses the fiber optic cable includes a distal end presenting an opening forming an angle of 90 degrees or 180 degrees relative to an optical path through the fiber optic cable (wider angles of illumination…using a fiber bundle [0048]; longitudinal movement of the light source and/or light detecting instrument within the balloon can change the field of view [0047]; the Examiner interpreted the fiber optical cable to have an opening to faces the optical path and would be 180 degrees).
Regarding claim 8, Ransbury further discloses the inflatable balloon is selectively movable between a collapsed position sized to move through the working channel of the endoscope and an expanded position sized to engage the subject after being deployed from the working channel of the endoscope (movable between a collapsed…inflated state [0031]; Ransbury | the balloon would be in an uninflated state when moving through the working channel of the endoscope).
Regarding claim 10, Ransbury further discloses the light source is coupled to a guide wire (light source…inner tube retracts [0047]; Ransbury | inner tube…housing a guide wire [0027]), and the guide wire is configured to arrange the light source in a desired position within the inflatable balloon (inner tube retracts [0047]).
Regarding claim 33, Gjorsvik further teaches the predetermined distance of the light source from the inner surface of the inflatable balloon when the light source is passed through the lumen of the sheath (expansion and positioning balloon provides for a minimum distance…[0047]; Gjorsvik), into the inflatable balloon determines a power setting of the light source (light dose…relates to the minimum distance…[0047]).
Regarding claim 34, Gjorsvik further teaches the predetermined distance of the light source from the inner surface of the inflatable balloon is approximately half of a diameter of the inflatable balloon (see location of 22 with respect to 18, figure 2; Gjorsvik).
Regarding claim 35, Gjorsvik further teaches the predetermined distance of the light source from the inner surface of the inflatable balloon is approximately half of a width of the inflatable balloon (see location of 22 with respect to 18, figure 2; Gjorsvik).
Regarding claim 36, Gjorsvik further teaches the treatment parameters include at least one power setting of the light source (required period of time to provide a required light dose…[0112]; Gjorsvik | broadly interpreted the power setting can be the light dose).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ransbury (US 2016/0143522) and Tearney (US 2012/0004506) and Gjorsvik (US 2018/0369603) as applied to claim 1 above, and further in view of Tearney (US 2007/0274650).
Ransbury and Tearney and Gjorsvik disclose all of the features in the current invention as shown above in claim 1. Ransbury discloses the balloon may be made with variable sizes and shapes to fit into desired anatomy ([0028]). They are silent regarding the inflatable balloon has a maximum diameter between 14 millimeters and 25 millimeters.
Tearney teaches a balloon catheter (see figure 1a) that can be used within the esophageal lumen ([0073]). The balloon (2040, figure 1a) can have an inflated diameter of 1.8 cm ([0073]).
It would have been obvious to one of ordinary skill in the art to modify the device to have a balloon with an inflated diameter of 1.8 cm (or 18 mm [0073]) as taught by Tearney. Doing so would allow the device, specifically the balloon catheter, to be used in the esophageal lumen ([0073]; Tearney).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ransbury (US 2016/0143522) and Tearney (US 2012/0004506) and Gjorsvik (US 2018/0369603) as applied to claim 1 above, and further in view of Fukushima (US 2019/0174995).
Ransbury and Tearney and Gjorsvik disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the light source includes an advancement marker on a proximal end, and wherein the advancement marker displays a measure of placement of the light source within the inflatable balloon.
Fukushima teaches a treatment tool (1, figure 1) for an endoscope, where the treatment tool has a sheath (2, figure 1), a balloon (3, figure 1), a stylet (6, figure 1), and a positioning marker (7, figure 1). The positioning marker may be providing by painting an outer surface of the stylet with paint or putting a tape ([0039]). The markers can be a color that is complementary to the color of a surface of a tissue to provide contrast and improve visibility of the marker ([0040]). The color of the marker needs to be visible to the imager of the endoscope ([0040]).
It would have been obvious to one of ordinary skill in the art to modify the light source of Ransbury to have a positioning marker (7, figure 1) on its proximal end as taught by Fukushima. Doing so would provide the amount/distance of advancing/retracting of the light source ([0048]). The modified device would have the light source includes an advancement marker (7, figure 1; Fukushima) on a proximal end, and wherein the advancement marker displays a measure of placement of the light source within the inflatable balloon (amount/distance of advancing/retracting [0048]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ransbury (US 2016/0143522) and Tearney (US 2012/0004506) and Gjorsvik (US 2018/0369603) as applied to claim 1 above, and further in view of Schaeffer (US 2012/0303011).
Ransbury and Tearney and Gjorsvik disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the inflatable balloon forms a mask to control a direction of light delivery from the light source to the subject.
Schaefer teaches a catheter (110, figure 2) with a balloon (134, figure 2). The proximal (138, figure 2) and distal (140, figure 2) portions of the balloon can have a mask applied to it ([0052]). The mask(s) limit the radially-directed light (182, figure 2) to the working length (150, figure 2) of the balloon ([0051]).
It would have been obvious to one of ordinary skill in the art to modify the device to apply a mask(s) to the balloon ([0052]) as taught by Schaeffer. Doing so would limit the radially-directed light to the working length of the balloon ([0051]). The modified device would have the inflatable balloon forms a mask to control a direction of light delivery from the light source to the subject ([0051]-[0052]; Schaeffer).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ransbury (US 2016/0143522) and Tearney (US 2012/0004506) and Gjorsvik (US 2018/0369603) as applied to claim 1 above, and further in view of Dietrich (US 4,612,938).
Ransbury and Tearney and Gjorsvik disclose all of the features in the current invention as shown above in claim 1. They are silent regarding a scattering medium arranged in the inflatable balloon to scatter light from the light source.
Dietrich teaches a transparent balloon (17, figure 2) with a light dispersing or scattering medium (4, figure 2) contained inside it. The transparent balloon is at the end of a catheter (18, figure 2). A light conductor (19, figure 2) is used for irradiation for diagnosis and therapy (Col. 3, lines 59-60). The scattering medium can be fat emulsified in water (Col. 4, lines 55-57).
It would have been obvious to one of ordinary skill in the art to modify the device to inflate the balloon with a scattering medium, like fat emulsified in water (Col. 4, lines 55-57), as taught by Dietrich. Doing so would allow for irradiation to be used for diagnosis and/or therapy (Col. 3, lines 59-60; Dietrich). The modified device would have a scattering medium (4, figure 2) arranged in the inflatable balloon to scatter light from the light source (Col. 3, lines 59-60).
Regarding claim 14, Dietrich further teaches the scattering medium includes at least one of a water-fat emulsion (fat emulsified in water; Col. 4, lines 55-57) or titanium dioxide solution.
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 PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
March 4, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795