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 .
Joint Inventors
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.
Response to Amendments
Applicant’s amendment filed 04/06/2026 has been considered and entered.
The rejections under35 USC 112 set forth in the office action received 12/16/2025 are withdrawn in view of the applicant’s amendments.
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive.
With regards to claims 1 and 42, Applicant has argued
that Uto does not disclose a structure wherein “…the first cladding itself…” functions “…as an optical transmission region in which light propagates and from which the light is leaked…”,
that Uto does not disclose “…light being transmitted inside a cladding layer and leaking radially outward from the cladding…”, and
that “…Uto does not disclose a first cladding including a leakage portion that leaks light transmitted inside the first cladding…”.
However, Examiner respectfully disagrees with all of 1-3 above.
Elements 21b and 21ba of Uto have been respectively mapped as the “…first cladding…” and the “…leakage portion…”. Applicant’s “first cladding” functions as a light propagation region surrounding a core. Element 21b of Uto functions as a light propagation region surrounding a core. Furthermore, Uto explicitly shows light being leaked from the position of element 21ba, and in a direction radially outward from element 21b (Figure 9). Thus, Examiner maintains the rejection set forth in the office action received 12/16/2025.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 11-12, 14-15, 17, 19-20, and 42-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Uto (US 20220226665 A1).
With regards to claims 1 and 42, Uto discloses an irradiation probe system, comprising:
an irradiation probe (Uto/Fig1/Irradiation probe 1) having a core and first cladding surrounding the core (Fig9/Core 21a and first cladding 21b);
at least one light source (Fig1/Light source 42); and
a coupling portion that couples light output by the at least one light source, to at least one of the core and the first cladding (Fig1/Coupling portion [Portion of element 1 between elements 40 and 42]), wherein the core includes a first input end portion at one end of an axis of the core (Fig1/Axis defined by elongate direction of element 20), and an output end portion that is at the other end of the axis (Fig1/Input end portion [Portion of core within region labeled “B” below]; Output end portion [Portion of core within region labeled “A” below]),
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and the first cladding includes:
a second input end portion at one end of the axis (Figs1&8/Second input end [Portion of element 21b as shown in fig8, at the location “B” above]); and
a leakage portion (Fig9/Leakage portion 21ba) that is provided at a position separate from the second input end portion and leaks, radially outward, light transmitted inside the first cladding, from an outer peripheral surface of the first cladding (Fig9).
With regards to claims 2 and 43, Uto discloses the irradiation probe system according to claim 1, wherein light transmitted inside the core is output from the output end portion (Figs1&9).
With regards to claim 3, Uto discloses the irradiation probe system according to claim 1, comprising, as the at least one light source:
a light source that outputs light to be coupled to the core (Paragraph 72/Lines 13-14); and
a light source that outputs light to be coupled to the first cladding (Paragraph 72/Lines 14-15).
With regards to claims 4 and 44, Uto discloses the irradiation probe system and irradiation probe according to claims 1 and 42,, wherein the irradiation probe includes a first covering layer between the second input end portion and the leakage portion, the first covering layer surrounding the outer peripheral surface of the first cladding (Fig9/First covering layer 23).
With regards to claims 5 and 45, Uto discloses the irradiation probe system and irradiation probe according to claims 4 and 44, wherein the first covering layer includes second cladding having a refractive index lower than that of the first cladding (Paragraph 73/Lines 5-8).
With regards to claims 6 and 46, Uto discloses the irradiation probe system and irradiation probe according to claims 1 and 42, wherein the irradiation probe includes an outer cover surrounding a surface of the irradiation probe, the surface being radially outermost (Figs1&9/Outer cover 10).
With regards to claims 7 and 47, Uto discloses the irradiation probe system and irradiation probe according to claims 6 and 46, wherein the outer cover is made of a resin material (Paragraph 42).
With regards to claim 8, Uto discloses the irradiation probe system according to claim 1, wherein the irradiation probe includes a section at a position separate, along the axis, from the leakage portion, the section being where the outer peripheral surface of the first cladding is exposed (Fig9/Section [Section within region labeled “A” below]).
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With regards to claim 9, Uto discloses the irradiation probe system according to claim 1, wherein the irradiation probe includes a second covering layer that surrounds the core or the first cladding, the second covering layer being provided on a side of the leakage portion opposite to the first input end portion along the axis, the second covering layer reducing coupling of light from outside to the core (Fig9/Second covering layer [Element 13 and section of element 10 to the left of element 12]).
With regards to claim 11, Uto discloses the irradiation probe system according to claim 1, wherein the irradiation probe includes a second covering layer that surrounds the core or the first cladding, the second covering layer being provided on a side of the leakage portion opposite to the first input end portion along the axis, the second covering layer reducing output, along the axis, of the light transmitted inside the first cladding (Fig9/Section of element 10 to the left of element 12).
With regards to claim 12, Uto discloses the irradiation probe system according to claim 1, comprising a first optical element that directs, at the output end portion, light transmitted in the core, radially outward (Fig9/First optical element “A” as labeled below).
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With regards to claim 14, Uto discloses the irradiation probe system according to claim 1, wherein the leakage portion includes a recessed portion or a protruding portion provided on the outer peripheral surface of the first cladding (Fig9/Recessed portion 23a).
With regards to claims 15 and 48, Uto discloses the irradiation probe system and irradiation probe according to claims 1 and 42, wherein the leakage portion includes particles or holes provided inside the first cladding (Paragraph 80/Lines 1-2).
With regards to claim 17, Uto discloses the irradiation probe system according to claim 1, wherein the leakage portion includes a curved portion of the first cladding (Figs7-9 [Outer surface of cladding 21b is curved]).
With regards to claim 19, Uto discloses the irradiation probe system according to claim 1, wherein the first input end portion and the second input end portion are arranged in a radial direction at one end of the axis, and the coupling portion couples light output from one of the at least one light source to the core and couples light output from another one of the at least one light source to the first cladding (Figs1&8/Elements 21a and 21b [and by extension, the end portions] are arranged in a radial direction).
With regards to claim 20, Uto discloses the irradiation probe system according to claim 1, wherein the coupling portion is optically connected to the core and the first cladding (Fig1).
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.
Claims 13, 18, 32-41, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Uto (US 20220226665 A1), as applied to claims 1 and 42 above.
With regards to claim 13, Uto discloses the irradiation probe system according to claim 12, but does not specify whether or not the first optical element is configured to be detachable. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (Nerwin v. Erlichman, 168 USPQ 177, 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the first optical element of Uto to be detachable since doing so would allow for further disassembly and for further maintenance advantages associated with replaceable parts.
With regards to claim 18, Uto discloses the irradiation probe system according to claim 1, but is silent regarding the presence of a dedicated scattering layer. However, Uto does disclose the presence of light diffusing particles within the first cladding (Paragraph 20). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to separate an outer portion of the first cladding disclosed by Udo into a dedicated scattering layer since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (Nerwin v. Erlichman, 168 USPQ 177, 1).
With regards to claim 32, Uto discloses the irradiation probe system according to claim 1, comprising:
a third optical element (Fig9/Third optical element [“A” as labeled below]):
having a reflection portion that reflects second light output from the other end of the axis of the irradiation probe (Fig9/Reflection portion 22); and
wherein the irradiation probe system is configured so that the second light reflected by the reflection portion is coupled to the first cladding, at the other end (Figs1&9).
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Uto does not specifically state that the third optical element is configured to be detachable from the irradiation probe. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the third optical element of Uto to be detachable since doing so would allow for further disassembly and for further maintenance advantages associated with replaceable parts.
With regards to claims 33 and 49, Uto discloses the irradiation probe system and irradiation probe according to claims 1 and 42, wherein the irradiation probe includes an outer cover (Fig9/Outer cover composed of elements 10, 12, 13, and 31). Uto does not specifically state that the outer cover is configured to be detachable from the irradiation probe. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the outer cover of Uto to be detachable since doing so would allow for further disassembly and for further maintenance advantages associated with replaceable parts.
With regards to claim 34, Uto discloses the irradiation probe system according to claim 33, wherein the irradiation probe includes, as the outer cover, plural outer covers (Fig9/Outer covers 12 and 13). Uto does not specifically state that the plural outer covers are configured to be detachable. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the plural outer covers of Uto to be detachable since doing so would allow for further disassembly and for further maintenance advantages associated with replaceable parts.
With regards to claim 35, Uto discloses the irradiation probe system according to claim 34, wherein the irradiation probe includes, as the outer cover, plural outer covers that are at different positions along the axis (Fig9/Outer covers 12 and 13).
With regards to claim 36, Uto discloses the irradiation probe system according to claim 35, wherein the irradiation probe includes, as the outer cover, an outer cover covering the output end portion (Fig9/Outer cover 13) and an outer cover covering an outer periphery of the leakage portion (Fig9/Outer cover 12).
With regards to claim 37, Uto discloses the irradiation probe system according to claim 33, wherein the irradiation probe includes a fixed outer cover (Fig9/Fixed outer cover 13) and an outer cover that covers the fixed outer cover removably or detachably (Paragraph 87/Removable outer cover [“Balloon”]).
With regards to claim 38, Uto discloses the irradiation probe system according to claim 33, wherein the irradiation probe includes, as the outer cover, plural outer covers that have been layered over one another (Fig9/Outer covers 13 and 31).
With regards to claim 39, Uto discloses the irradiation probe system according to claim 38. Uto does not specifically state that the plural outer covers that have been layered over one another are configured to be removable one by one from outside. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the plural outer covers that have been layered over one another of Uto to be detachable since doing so would allow for further disassembly and for further maintenance advantages associated with replaceable parts.
With regards to claim 40, Uto discloses the irradiation probe system according to claim 33, wherein the outer cover is provided at a portion that comes into contact with a living body upon use for the living body (Paragraph 8/“…catheter…”).
With regards to claim 41, Uto discloses the irradiation probe system according to claim 33, wherein the outer cover is made of a biocompatible resin material (Paragraph 42).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Uto (US 20220226665 A1) as applied to claim 1 above, in view of Sinofsky (US 20110212411 A1).
With regards to claim 16, Uto discloses the irradiation probe system according to claim 1, but is silent regarding the leakage portion including a section where the outer peripheral surface of the first cladding changes in shape along the axis. However, the practice of configuring an outer peripheral surface of a first cladding to include changes in shape exits in the art as exemplified by Sinofsky.
Uto and Sinofsky are considered to be analogous in the field of optical therapy devices. Uto discloses an irradiation probe with a leakage portion including an outer peripheral surface of a first cladding. Sinofsky discloses a leakage portion (Sinofsky/Fig2/Leakage portion 40) including an outer peripheral surface of a first cladding which includes changes in shape (Sinofsky/Fig2/First cladding 34). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply shape changes to the outer peripheral surface of the first cladding within the leakage portion disclosed by Uto as suggested by Sinofsky since doing so would permit the emission of a scattered light in a fashion defined and controlled in part by the physical characteristics of the shape changes.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Uto (US 20220226665 A1) in view of Rose (US 20180113247 A1) , as applied to claim 1 above.
With regards to claim 10, Uto discloses the irradiation probe system according to claim 9, wherein the second covering layer reduces output of the light transmitted inside the first cladding, but does not disclose a reduction in output along the axis. However, the practice of configuring an irradiation probe such that output is reduced along the elongate axis of the probe exists in the art as exemplified by Rose.
Uto and Rose are considered to be analogous in the field of optical therapy devices. Rose discloses an optical probe wherein a second covering layer reduces output along the elongate axis (Rose/Fig12/Second covering layer [Elements 360 and 314]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the second covering layer of Uto such that it reduced output along the elongate axis of the probe, since doing so would further allow for the prevention of light escaping from the front of the device.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over (US 20220226665 A1) as applied to claim 1 above, in view of Nishina (WO 2010067510 A1).
With regards to claim 21, Uto discloses the irradiation probe system according to claim 1, wherein the coupling portion includes:
a first transmission optical fiber (Fig1 [Connection between elements 42 and 41]) that transmits light output by one of the at least one light source and coupled to the core and the first cladding.
Uto is silent regarding the coupling portion including a fiber bundle and regarding the fiber bundle comprising a second transmission optical fiber that transmits light output by another one of the at least one light source and coupled to the first cladding. However, the practice of configuring a coupling portion to comprise a fiber bundle with two transmission optical fibers exists in the art as exemplified by Nishina.
Uto and Nishina are considered to be analogous in the field of optical fibers. Uto discloses an irradiation probe system with a coupling portion that couples a light source to a core and a first cladding. Nishina discloses a coupling portion including a fiber bundle with a first transmission optical fiber that transmits light output by a light source and a second transmission optical fiber that transmits light output by another light source (Nishina/Fig1/First and second optical fibers 12b; Fig6/Light sources 71). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the coupling portion of Uto such that it comprised a fiber bundle with a first and second transmission optical fiber as suggested by Nishina since doing so would allow for a greater degree of control over the optical signals sent through the probe.
With regards to claim 22, Uto and Nishina together disclose the irradiation probe system according to claim 21, wherein the fiber bundle is a tapered fiber bundle that is tapered toward the irradiation probe (Nishina/Fig1).
Claims 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Uto (US 20220226665 A1) as applied to claim 1 above, in view of Swanson (US 20210341668 A1).
With regards to claim 23, Uto discloses the irradiation probe system according to claim 1, but is silent regarding:
a switchover mechanism that performs selective coupling of light output by the light source to the core or to the first cladding; and
a first control unit that controls the selective coupling by the switchover mechanism.
However, the practice of including a switchover mechanism that performs selective light coupling and a control unit within an irradiation probe system exists in the art as exemplified by Swanson.
Uto and Swanson are considered to be analogous in the field of optical probes. Uto discloses an irradiation probe system with a core, a first cladding, and a light source coupled to the core and the first cladding. Swanson discloses a probe comprising:
a switchover mechanism (Swanson/Fig2a/Switchover mechanism 203) that performs selective coupling of light; and
a first control unit (Swanson/Fig2a/First control unit 202) that controls the selective coupling by the switchover mechanism.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the irradiation probe system of Uta such that it included a switchover mechanism and first control unit as suggested by Swanson since doing so would allow for greater control over the light within the probe.
With regards to claim 24, Uto and Swanson together disclose the irradiation probe system according to claim 23, comprising: an operation input unit for a user, wherein the first control unit controls the selective coupling by the switchover mechanism according to input of an operation by the user to the operation input unit (Swanson/Paragraph 28).
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Uto (US 20220226665 A1) as applied to claim 1 above, in view of Fujuta (US 20180084977 A1).
With regards to claim 25, Uto discloses the irradiation probe system according to claim 1, but does not disclose the at least one light source as comprising plural light sources, and a second control unit that performs switchover between light sources to output light, among the plural light sources. However, the practices of configuring an irradiation probe system to include multiple light sources and a control unit that performs switchover between light sources to output light exists in the art as exemplified by Fujita.
Uto and Fujita are considered to be analogous in the field of optical probes. Uto discloses an irradiation system with at least one light source coupled to a core and first cladding of a probe. Fujita discloses a plurality of light sources coupled to a probe (Fujita/Fig20; Paragraph 85/Lines 1-6) and a control unit that performs switchover between light sources to output light (Fujita/Fig20; Paragraph 161/Lines 1-4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the irradiation probe system of Uta such that it included a plurality of light sources as the at least one light source and a control unit to perform switchover between light sources to output light as suggested by Fujita since doing so would allow for greater control over the light within the probe.
With regards to claims 26, Uta and Fujita disclose the irradiation probe system according to claim 25, wherein the plural light sources include a light source that outputs light to be coupled to the core and a light source that outputs light to be coupled to the first cladding (Fujita/Core 54 and first cladding 56 [Light from the plurality of sources is coupled to the core and the first cladding]).
With regards to claim 27, Uta and Fujita together disclose the irradiation probe system according to claim 25, wherein the plural light sources include plural light sources that output light to be coupled to the core or plural light sources that output light to be coupled to the first cladding (Fujita/Core 54 and first cladding 56 [Light from the plurality of sources is coupled to the core and the first cladding]).
With regards to claim 28, Uta and Fujita together disclose the irradiation probe system according to claim 25, comprising: an operation input unit for a user (Fujita/Fig20/Operation input unit 102), wherein the second control unit performs switchover between light sources to output light, among the plural light sources (Fujita/Paragraph 161), according to input of an operation by the user to the operation input unit (Fujita/Paragraph 156/ User [Endoscope operator]).
Claims 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Uto (US 20220226665 A1) as applied to claim 1 above, in view of Yamada (US 20200085285 A1).
With regards to claim 29, Uto discloses the irradiation probe system according to claim 1, but is silent regarding a light detection unit. However, the practice of incorporating a detection unit that detects light coupled to the output end portion, transmitted inside the core, and output from the first input end portion exists in the art as exemplified by Yamada.
Uto and Yamada are considered to be analogous in the field of optical probes. Yamada discloses an irradiation probe system comprising a detection unit (Yamada/Fig1/Detection unit 122) that detects light coupled to the output end of the probe, transmitted inside the core of the probe, and output from a first input end portion of the probe (Yamada/Fig1/Probe 160). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a light detection unit into the irradiation probe system disclosed by Uta as suggested by Yamada since doing so would allow for further means of determining when the optical probe is disconnected or improperly aligned.
With regards to claim 30, Uto and Yamada together disclose, the irradiation probe system according to claim 29, wherein the irradiation probe includes a second optical element (Uto/Fig9/Second optical element 13) that couples light coming from outside, to the output end portion.
With regards to claim 31, Uto and Yamada together disclose the irradiation probe system according to claim 30, but are silent regarding whether or not the second optical element is configured to be detachable. Uto and Yamada do not specifically state that the second optical element is configured to be detachable. However, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. Nerwin v. Erlichman, 168 USPQ 177, 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the second optical element of Uto to be detachable since doing so would allow for further disassembly and for further maintenance advantages associated with replaceable parts.
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc E Manheim whose telephone number is (703)756-1873. The examiner can normally be reached 6:30am - 5pm E.T., Monday - Tuesday and Thursday - Friday.
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/MARC E MANHEIM/Examiner, Art Unit 2874
/THOMAS A HOLLWEG/Supervisory Patent Examiner, Art Unit 2874
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