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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, an air insufflation part must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is formed of more than one paragraph. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 1-3 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over US Pub. No.: US 2004/0039242 A1 to Tolkoff et al. (hereinafter “Tolkoff”) and in view of JP 6463218 B2 to Kitaoka et al. (hereinafter “Kitaoka”) and in view of JP 2015221174 A to Haga et al. (hereinafter “Haga”).
Regarding Claim 1, Tolkoff teaches a low-level laser therapy device (“light treating device 100”, see Para. 49 and 56) using a light-emitting diode (LED) (see “a light emitting diode” in Para. 12) endoscope cap, the low-level laser therapy device comprising: a catheter (“a surgical instrument e.g., a catheter”; see Para. 56) which is formed to extend so as to be inserted into a body of a patient (“so that it can be easily introduced into the esophagus and stomach, either by itself or, if desired, through an appropriate flexible endoscope” see Para. 124) and includes an air insufflation part (“a gas, e.g., air, to be used for balloon inflation” see Para. 128, also see Para. 140) for stretching the mucosal folds of the duodenum of the patient;
and one or more LEDs disposed on each of the endoscope cap and the hood (“reflective particles 402, is attached to a distal end of the light guide” see Fig 4A and Para. 61).
However, Tolkoff fails to teach an endoscope cap having a through hole therein to allow the catheter to be inserted therethrough.
Kitaoka teaches similar laser treatment apparatus for an endoscope in which a cap having a through hole (“a cap having a hole” see Para 6) therein to allow the catheter to be inserted therethrough (“the tip of the optical fiber is inserted into the hole” Para. 36).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify Tolkoff to incorporate a hole in the cap as taught by Kitaoka to allow a better guided insertion and secure fixation of the catheter.
Tolkoff does not appear to 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. However, Haga, teaches a similar apparatus with a hood disposed in one region outside the endoscope cap (“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” see Abstract) and disposed such that at least one region thereof protrudes forward from the endoscope cap (“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” see Para. 26 and Fig 4-5).
Accordingly, it would have been obvious to one of ordinary skill in the art as of the filling date of the invention to modify and combine Tolkoff and Kitaoka to incorporate a hood outside the endoscope cap, as taught by Haga, so that the endoscope cap could be modified with a hood to provide more area of treatment and better visual field.
Regarding Claim 2, the combination of Tolkoff, Kitaoka, and Haga applied above, teaches a similar apparatus 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 Tolkoff in view of Kitaoka and further 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 3, Tolkoff in view of Kitaoka 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 in which a cap having a curved surface at the end portion (“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 Tolkoff in view of Kitaoka and further Haga 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.
Regarding Claim 6, the combination of Tolkoff, Kitaoka, and Haga 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 Tolkoff in view of Kitaoka and further 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.
Regarding Claim 7, Tolkoff in view of Kitaoka 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).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tolkoff in view of Kitaoka 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, Tolkoff in view of Kitaoka 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 Tolkoff in view of Kitaoka 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, Tolkoff in view of Kitaoka further in view of Haga, teach the modified therapy device in claim 4 as discussed 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 Tolkoff in view of Kitaoka 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 Tolkoff in view of Kitaoka 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, Tolkoff 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 Tolkoff in view of Kitaoka 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/I.J./Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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