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
The amendment filed on 06/24/2026 has been entered. Claim 1-8 remain pending in the application. Applicant’s amendment to the drawing and specification have overcome the drawing objection and specification objection previously set forth in the Non-final Office Action mailed on 03/27/2026.
Response to Arguments
Drawings Objection:
Applicant's drawing amendment have successfully overcome the previous objections. The objections have been withdrawn.
Specification Objection:
Applicant's specification amendment has successfully overcome the previous objections. The objections have been withdrawn.
Rejection under 35 U.S.C § 103:
Applicant’s arguments, see page 7-13, filed on 06/02/2026, with respect to the rejection(s) of claim(s) 1-8 under 35 U.S.C § 103 have been fully considered and are persuasive. Therefore, the previous rejection has been withdrawn. However, upon further search and consideration, a new ground(s) of rejection is made in view of newly found prior art reference(s).
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over EP 3701850 A1 to Yoshida (hereinafter “Yoshida”) and in view of US 20040039242 A1 to Tolkoff et al. (hereinafter “Tolkoff”) and in view of JP 2015221174 A to Haga et al. (hereinafter “Haga”).
Regarding Claim 1, Yoshida teaches a low-level laser therapy device (see Para 09: “An applicator device for an endoscope”, and Para 77: “the applicator 42 can be used in a photodynamic therapy (PDT)”) using a light-emitting diode (LED) endoscope cap (see Para 09: “an applicator device for an endoscope including an applicator attachable to and removable from an insertion part of the endoscope to be inserted into a body cavity, and the applicator comprises a light emitting element that irradiates an affected area of a biological tissue in the body cavity with excitation light”, and see Fig.6-7 (applicator 42 and LED chips 64), also Para 22: “the light emitting element according to the present aspect is a light emitting diode”), the low-level laser therapy device comprising:
an endoscope cap having a through hole therein to allow the catheter to be inserted therethrough (see Para 40-44: “The applicator 42 possesses, for example, a cylindrical shape and is formed of a resin having flexibility to be easily attachable to and removable from the tip portion 24 … the forceps opening 32 and the air/water-feeding port 34 can be exposed in the body cavity. Consequently, also in a state where the applicator 42 is mounted to the tip portion 24, the treatment instrument 30 can enter and exit through the forceps opening 32, and another function of the endoscope 4 is not restricted … Each of the channels 66 is formed to extend through a circumferential portion 42c of the applicator 42 from the tip surface 42a to the end face 42b … respective probe tubes constituting the probe tube bundle 56 arranged in the universal cord 62 are connected to openings of the respective channels 66 in the end face 42b (cap like applicator over endoscope having through hole extending through cap body, through which delivery tubes are inserted/connected)”, also see Fig. 3-4, 6-7);
one or more LEDs disposed on each of the endoscope cap and the hood (see Para 43: “in a tip surface 42a of the applicator 42 … a large number of LED chips (light emitting elements or light emitting diodes) 64 are provided along a circumferential direction of the tip surface”, also Para 68-69: “the LED chips 64 and channels 66 provided in the tip surface 42a of the applicator 42 are not restrictive, and may be arranged and opened in the circumferential portion 42c of the applicator 42 … it is preferable that the respective LED chips 64 and the respective channels 66 are arranged and opened in separate annular arrays along the circumferential direction of the circumferential portion 42c (disclose distributing LED chips across multiple regions of the cap/hood structure)” and Fig. 6-7 (LED 64 in multiple region)),
wherein the one or more LEDs are configured to emit light in response to power supplied thereto (see Para 16: “an endoscope system comprising a light source device that generates illumination light … the applicator device for the endoscope further comprises a power source device that supplies power to the light emitting element” and Para 56: “the power source device 44 supplies power to the respective LED chips 64 … the respective LED chips 64 emit excitation light 88”).
However, Yoshida fails to teach the low level laser therapy device having a catheter which is formed to extend so as to be inserted into a body of a patient and includes an air insufflation part for stretching the mucosal folds of the duodenum of the patient.
Tolkoff teaches a similar treatment apparatus (see Para 16: “an apparatus for killing or debilitating pathogenic microorganisms within a patient's body, the apparatus including a light source dimensioned for insertion into a patient's body”, and Para 69: “light treating device“), a catheter (see Para 56: “a surgical instrument e.g., a catheter”) which is formed to extend so as to be inserted into a body of a patient (see Para 88: “The light guide can be inserted into the stomach through the shaft of a balloon catheter and the assembly inserted in the stomach”) catheter inserted into the patient body carrying the light delivery assembly)”, also Para 124) and includes an air insufflation part (see Para 125-128: “a gas, e.g., air, to be used for balloon inflation”, and Para 140) for stretching the mucosal folds of the duodenum of the patient (see Para 91-94: “Inflation can be accomplished using a gas, a balloon … and/or a liquid …” and Para 10,: “a treatment method and apparatus for debilitating and/or killing H. pylori or other microorganisms within a patient's body and is especially suited for treating stomach or duodenal ulcers. The present therapeutic method involves the use of visible light for eliminating pathogenic microorganisms within or supported upon the lining of a body cavity of a patient, e.g., the stomach”, also 140).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify the discloser of Yoshida to incorporate a catheter having an air insufflation part taught by Tolkoff to stretch the mucosal folds of duodenum so that the arranged LED chips can deliver more uniform, unobstructed light to tissue that would otherwise be within folds.
Yoshida teach the cap having through hole to allow catheter to be inserted, and distributing LED chips across multiple regions of the cap/hood structure to irradiated a broader area, but does not teach a hood disposed in one region outside the endoscope cap and disposed such that at least one region thereof protrudes forward from the endoscope cap.
Another reference, Haga, teaches a similar apparatus (see Abstract: a hood for an endoscope”) with a hood disposed in one region outside the endoscope cap (see Abstract: “a hood body 11 having an endoscope connection part 13 connected to a tip of an endoscope insertion part 20 on the base end side”), and disposed such that at least one region thereof protrudes forward from the endoscope cap (see Para 26: “a plurality of opening / closing bodies 12 that are supported on the distal end side of the hood body 11 so as to be freely opened and closed” and Fig 2-5, and Claims).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify/combine Yoshida to incorporate a hood outside the endoscope cap, as taught by Haga, also to distribute the LEDs across so broader area in the body cavity can be irradiated with the excitation light by the respective LED chips (see Yoshida Para 68), so that the endoscope cap with modified hood can provide more area of treatment and better visual field.
Regarding Claim 2, the combination of Yoshida, Tolkoff, and Haga as applied to claim above, teach the therapy device above, but fails to teach the hood is formed to have a joint structure.
Haga further teaches the similar apparatus (see Abstract: a hood for an endoscope”) wherein the hood is formed to have a joint structure (“connected by a hinge mechanism or the like” see Haga Para. 35 and Fig 6).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify Yoshida in view of Tolkoff and further in view of Haga to incorporate to have the hood to have a joint structure as taught by Haga to improve structural flexibility and reduce risk of damage inside the body.
Regarding Claim 6, the combination of Yoshida, Tolkoff, and Haga as applied above, teach the therapy device of claim 1 as discussed above, but fails to specifically teach a movable hood such that at least one region thereof forms a predetermined angle with respect to the endoscope cap.
Haga does, however, teach a similar apparatus wherein the hood is movable such that at least one region thereof forms a predetermined angle with respect to the endoscope cap (“the open / close bodies 12 have their tip portions simultaneously moved radially outward” see Para. 42-43 and Fig 1-2).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify Yoshida in view of Tolkoff and further in view of Haga to incorporate to have the hood to joint in ways such that it would be movable and would provide a larger field of view and/or treatment areas.
Regarding Claim 7, Yoshida in view of Tolkoff and further in view of Haga, teach the therapy device of claim 1 as discussed above, but fails to specifically teach a band having a diameter less than a diameter of the through hole.
Tolkoff, teach a similar apparatus wherein a band having a diameter less than a diameter of the through hole is inserted into the through hole (“has an outer diameter of less than or equal to” see Para. 0124, also Para 56-57).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify Yoshida in view of Tolkoff and further in view of Haga to incorporate to have the band having a diameter less than diameter of the through hole, thereby allowing the inserted band to be freely advanced/inserted, withdrawn, and/or rotate within the through hole without requiring excessive insertion force.
Claims 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida in view of Tolkoff and Haga as applied to claim 1 above, and further in view of JP 6463218 B2 to Kitaoka et al. (hereinafter “Kitaoka”).
Regarding Claim 3, Yoshida in view of Tolkoff and further in view of Haga, teach the therapy device as discussed above, but fails to specifically teach wherein the hood includes a curved region having a curved surface at one end thereof.
Kitaoka, teach similar laser treatment apparatus for an endoscope (see Description: “a laser treatment apparatus for an endoscope”) wherein the hood includes a curved region having a curved surface at one end thereof (“the cap 30 … curved surface shape” see Para 40).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify Yoshida in view of Tolkoff and Haga and further in view of Kitaoka to incorporate the hood to be a curved shaped surface at the end portion to reduce risk of damaging the patient organ when inserted into the patient's body.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Yoshida in view of Tolkoff and in view of Haga as applied to claim 1 above, and further in view of US 20160151639 A1 to Scharf et al. (hereinafter “Scharf”).
Regarding Claim 4, Yoshida in view of Tolkoff and further in view of Haga, teach the therapy device of claim 1 as discussed above, but fails to specifically teach a therapy device capable of irradiating light of different wavelengths into the patient body.
Scharf, teach a similar apparatus wherein a first LED configured to irradiate a first light of a first wavelength band (“The pulsed light can comprise a first pulse of light at a first wavelength” see Para. 42) is disposed on a surface of the endoscope cap (“light source can be operably connected to the light delivery element” see Para. 42), and a second LED configured to irradiate a second light of a second wavelength band (“and a second pulse of light at a second wavelength” see Para. 42) different from the first wavelength band (“Light source 150 can be constructed and arranged to deliver light at varying wavelengths, such as light provided at continuously varying wavelengths or light alternative between at least a first wavelength and a second wavelength. Light source 150 can be constructed and arranged to provide light at multiple wavelengths simultaneously.” see Para. 150) is disposed on a surface of the hood.
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify Yoshida in view of Tolkoff and Haga to incorporate to have a device capable of irradiating light of different wavelength from different parts of the device so that different light may irradiate in different direction and simultaneously treat different area of the patient’s duodenum.
Regarding Claim 5, Yoshida in view of Tolkoff and further in view of Haga, teach the modified therapy device as discussed in claim above, but fails to specifically teach a therapy device with predetermined wavelength band.
Scharf however, teach a similar apparatus wherein the first wavelength band is a predetermined wavelength band between 600 nm and 700 nm, and the second wavelength band is a predetermined wavelength band between 800 nm and 900 nm (“provide one or more wavelengths of light between 300 nanometers and 900 nanometers“, also see Para. 42, 150, and 201).
It would have been obvious to one of ordinary skill in the art as of the filling date of the invention to engage in experimentation to discover the optimal treatment parameter for each particular wavelength and find the optimal range for the treatment to modify Yoshida in view of Tolkoff and Haga to incorporate to have a device capable of irradiating light of different wavelength.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Yoshida in view of Tolkoff and Haga as applied to claim 1 above, and further in view of US 20190022406 A1 to Hill et al. (hereinafter “Hill”).
Regarding Claim 8, Yoshida as modified above, teach the therapy device of claim 1 as discussed above, but fails to specifically teach a therapy device with at least one LED with quantum dot as light source and a flexible organic light-emitting diode (OLED).
Hill however, teach a similar therapy apparatus wherein the LEDs include at least one of a quantum dot LED with quantum dots as a light source, and a flexible organic light-emitting diode (OLED) (“the light emitting device comprises a light emitting diode, an optical fiber, laser diodes, organic light emitting diodes (OLEDs) or quantum dots” see Para. 620).
It would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify Yoshida in view of Tolkoff and Haga to incorporate to have a device capable of having different light sources by simply substituting of one known therapeutic light source for another known therapeutic light source to obtain predictable results and to improve therapy efficiency.
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.
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/I.J./ Examiner, Art Unit 3792
/NIKETA PATEL/ Supervisory Patent Examiner, Art Unit 3792
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