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 .
This Office Action is in response to the amendments dated September 4, 2025.
Claims 12-13, 16-18, 21-25, 28-29, and 32-33 are pending.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: “diffusers” as set forth in claims 32 and 33 is a term not used in the Specification. The Examiner assumes these are the lenses 1149. Appropriate correction is required. To the extent Applicant considers the term “diffusers” to impart some structural or functional difference from a lens, the Examiner would have to consider the term unsupported by the original disclosure. Currently, the Examiner is considering the terms to be equivalent in scope.
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.
Claims 12-13, 16, 18, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hirata (US 2005/0182291) in view of Benning et al. (US 2013/0131447).
Regarding Claim 12, Hirata discloses:
A medical device comprising:
an outer tubular body (20 in Fig. 2 including 26) having a proximal end and a closed distal end (see Fig. 3A showing the proximal end 26 attached to the visualization stylet and the closed distal end with lens 21/22), the outer tubular body defining at least one conduit therein (see Fig. 3A showing the body 20 receiving the stylet 2), the outer tubular body defining a central optically transparent window (21) disposed within the closed distal end of the outer body (shown in Fig. 3A);
a removable visualization stylet (2) having a proximal end and a distal end (shown in Fig. 1), said visualization stylet being disposed within the conduit and being removable from the proximal end of the outer tubular body (the two are attached using a threaded configuration), wherein a distal end region of the visualization stylet includes an electronic photodetector chip (31) mounted thereon having a distally facing surface (distal surface of 31) configured to detect incoming light traveling along a proximal direction through the central optically transparent window disposed within the closed distal end of the outer body (see Fig. 3A showing the lens group in front of the CCD to direct light thereon); and
a plurality of micro-LED elements (22) disposed radially outwardly with respect to the electronic photodetector chip, the plurality of micro-LED elements being located radially inwardly with respect to an outer radial surface of the outer tubular body (see Fig. 3A, for example, showing the LEDs outward from the chip and inward from the outer surface of the tubular body); the plurality of micro-LED elements being distally oriented and configured to project light distally beyond the electronic photodetector chip in a distal direction to provide direct forward illumination (see Fig. 3A showing the forward direction of the LEDs), wherein the plurality of micro-LED elements are configured to direct light along a distal direction along a first optical pathway that is spatially distinct from and radially outwardly displaced from a second optical pathway associated with the electronic photodetector chip of the removable visualization stylet (see Fig. 3A showing the LEDs along a path that is different from the image sensor).
Hirata does not explicitly disclose wherein the visualization stylet is slidably disposed within the conduit and being slidably removable from the proximal end of the outer tubular body. The Examiner notes that threaded engagements and snap-on or friction fit configurations are well-known alternatives in the art. Benning teaches that caps can be secured using an interference fit, a snap fit, or threads (see Paragraph 0033). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hirata’s connection means to be a sliding one like a snap fit or interference fit where the cap slides onto the stylet. Such a modification is the simple substitution of one known for another to obtain predictable results.
Regarding Claim 13, Hirata as modified further discloses wherein the outer tubular body has a circular cross- section (see Hirata Figs. 2 and 5, for example, showing the circular cross-section of 20).
Regarding Claim 16, Hirata as modified further discloses at least one lens element disposed along the first optical pathway (Hirata’s LEDs include distal lens 22A).
Regarding Claim 18, Hirata as modified further discloses wherein the closed distal end of the outer tubular body has a blunted shape (see Hirata Fig. 3A showing the rounded corners of 20 at the distal end).
Regarding Claim 21, Hirata as modified further discloses wherein the plurality of micro-LED elements are disposed radially outwardly of and at least partially circumferentially surround the electronic photodetector chip (see Hirata Fig. 3A).
Regarding Claim 22, Hirata as modified further discloses wherein the plurality of micro-LED elements are disposed radially outwardly of and circumferentially surround the electronic photodetector chip (see Hirata Fig. 3A).
Claims 17, 23, 25, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Hirata (US 2005/0182291) and Benning et al. (US 2013/0131447), as applied to claim 12 above, and further in view of Adair et al. (US 2011/0034769).
Hirata and Benning disclose the invention substantially as claimed as stated above.
Regarding Claim 17, they do not explicitly disclose wherein the electronic photodetector chip is rectangular in shape. Circular and rectangular imaging chips are known in the art. Adair shows that the two are interchangeable (see Fig. 1b and Paragraph 0055). Both shapes are known in the art, and a person having ordinary skill in the art would consider them interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hirata’s device to have a rectangular photodetector chip. Such a modification is the simple substitution of one known shaped sensor for another to yield predictable results as is shown in the art.
Regarding Claim 23, Hirata discloses:
A medical device comprising:
an outer tubular body (20 in Fig. 2 including 26) having a proximal end and a closed distal end (see Fig. 3A showing the proximal end 26 attached to the visualization stylet and the closed distal end with lens 21/22), the outer tubular body defining at least one conduit therein (see Fig. 3A showing the body 20 receiving the stylet 2), the outer tubular body defining a central optically transparent window (21) disposed within the closed distal end of the outer body (shown in Fig. 3A);
a removable visualization stylet (2) having a proximal end and a distal end (shown in Fig. 1), said visualization stylet being disposed within the conduit and being removable from the proximal end of the outer tubular body (the two are attached using a threaded configuration), wherein a distal end region of the visualization stylet includes a electronic photodetector chip (31) mounted thereon having a distally facing surface configured to detect incoming light traveling along a proximal direction through the central optically transparent window disposed within the closed distal end of the outer body (see Fig. 3A showing the lens group in front of the CCD to direct light thereon); and
a plurality of lighting elements (22) disposed radially outwardly with respect to the electronic photodetector chip, the plurality of lighting elements being located radially inwardly with respect to an outer radial surface of the outer tubular body (see Fig. 3A, for example, showing the LEDs outward from the chip and inward from the outer surface of the tubular body); the plurality of lighting elements being distally oriented and configured to project light distally beyond the electronic photodetector chip in a distal direction to provide direct forward illumination (see Fig. 3A showing the forward direction of the LEDs), wherein the plurality of lighting elements are configured to direct light along a distal direction along a first optical pathway that is spatially distinct from and radially outwardly displaced from a second optical pathway associated with the electronic photodetector chip of the removable visualization stylet (see Fig. 3A showing the LEDs along a path that is different from the image sensor).
Hirata does not explicitly disclose wherein the visualization stylet is slidably disposed within the conduit and being slidably removable from the proximal end of the outer tubular body. The Examiner notes that threaded engagements and snap-on or friction fit configurations are well-known alternatives in the art. Benning teaches that caps can be secured using an interference fit, a snap fit, or threads (see Paragraph 0033). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hirata’s connection means to be a sliding one like a snap fit or interference fit where the cap slides onto the stylet. Such a modification is the simple substitution of one known for another to obtain predictable results.
Also, Hirata does not explicitly disclose wherein the electronic photodetector chip is rectangular in shape. Circular and rectangular imaging chips are known in the art. Adair shows that the two are interchangeable (see Fig. 1b and Paragraph 0055). Both shapes are known in the art, and a person having ordinary skill in the art would consider them interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hirata’s device to have a rectangular photodetector chip. Such a modification is the simple substitution of one known shaped sensor for another to yield predictable results as is shown in the art.
Regarding Claim 25, Hirata as modified further discloses wherein the outer tubular body has a circular cross-section (see Hirata Figs. 2 and 5, for example, showing the circular cross-section of 20).
Regarding Claim 28, Hirata as modified further discloses wherein the closed distal end of the outer tubular body has a blunted shape (see Hirata Fig. 3A showing the rounded corners of 20 at the distal end).
Regarding Claim 29, Hirata as modified further discloses wherein the plurality of lighting elements are disposed radially outwardly of and at least partially circumferentially surround the electronic photodetector chip (see Hirata Fig. 3A).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hirata (US 2005/0182291), Benning et al. (US 2013/0131447), and Adair et al. (US 2011/0034769), as applied to claim 23 above, and further in view of Yamamoto (US 4,706,653).
Hirata, Benning, and Adair disclose the invention substantially as claimed as stated above. Hirata uses LEDs for illumination. Fiber optics are old and well-known alternatives to LEDs. Yamamoto teaches using fiber optics for guiding light from the proximal end to the distal end of a scope with a similar cap (see fibers 25 and cap 13). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hirata’s lighting elements to be fiber optics as shown in Yamamoto. Such a modification is a simple substitution of known elements to yield predictable results. Fiber optics have been used for decades and allow for a simple means to transmit illumination light from the proximal end of the device to its distal end.
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Hirata (US 2005/0182291) and Benning et al. (US 2013/0131447), as applied to claim 12 above, and further in view of Boulais et al. (US 2007/0249907).
Hirata and Benning disclose the invention substantially as claimed as stated above; however, they do not explicitly disclose wherein the outer tubular body includes a plurality of discrete light diffusers, each said light diffuser corresponding to each said micro-LED element that is configured to diffuse distally-directed light originating from each said micro-LED element. Boulais teaches molding lenses into the cap to change the pattern of illumination light distribution (see Paragraph 0020). The Examiner notes that Applicant has not used the term “diffuser” and lenses are what are shown in the disclosure. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hirata’s device to include Boulais’ diffusers. Such a modification provides a means for distributing the light as desired.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Hirata (US 2005/0182291), Benning et al. (US 2013/0131447), and Adair et al. (US 2011/0034769), as applied to claim 23 above, and further in view of Boulais et al. (US 2007/0249907).
Hirata, Benning, and Adair disclose the invention substantially as claimed as stated above; however, they do not explicitly disclose wherein the outer tubular body includes a plurality of discrete light diffusers, each said light diffuser corresponding to each said micro-LED element that is configured to diffuse distally-directed light originating from each said micro-LED element. Boulais teaches molding lenses into the cap to change the pattern of illumination light distribution (see Paragraph 0020). The Examiner notes that Applicant has not used the term “diffuser” and lenses are what are shown in the disclosure. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hirata’s device to include Boulais’ diffusers. Such a modification provides a means for distributing the light as desired.
Response to Arguments
Applicant's arguments filed September 4, 2025, have been fully considered but they are not persuasive.
Applicant argued against the combination of Yoon and Hirata. The Examiner has removed that rejection, so the argument is moot.
The Examiner notes that Applicant has basically changed the claims from covering the combination of elements seen in Figs. 2A-2C to only include the visualization stylet as shown in Figs. 11A-11B. The “outer tube” as shown in the figures and referenced in the Specification was 220. Now, Applicant seems to consider the cap to be the claimed outer tube. This change broadens the claims significantly such that references directed to endoscopes with caps would read on them. At this time, the application is not in condition for allowance.
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 TIMOTHY JAY NEAL whose telephone number is (313)446-4878. The examiner can normally be reached Mon-Fri 7:30-5:30.
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/TIMOTHY J NEAL/ Primary Examiner, Art Unit 3795