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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/24/2025 has been entered.
Response to Amendment
Amendments to claims 1, 15 of 10/24/2025 acknowledged and entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claim(s) 1, 3, 5, 6, 9, 12, 13, 14, 15, 17, 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reydel (US 20120232342 A1) in view of Ouchi (US 20060173241 A1) and Leiner (US 20090043167 A1).
Regarding claim 1, Reydel discloses an optical coupler configured to cooperate with an endoscope, the optical coupler comprising;
an attachment section (218, Fig. 2, [0032]) comprising one or more elastic material(s) ([0028]) and dimensioned to be removably attached to a distal end of the endoscope ([0032]);
a visualization section (210, Fig. 2, [0031]) in contact with the attachment section (Fig. 2, [0032]) and at least partially surrounding a distal surface of the endoscope (Fig. 2)
wherein the optical coupler is configured for advancement within a lumen of a patient (210, Fig. 2, [0031 (see [0031]-[0035]).
Reydel fails to expressly teach the visualization section comprises a main body with an interior portion, wherein at least the interior portion of the main body comprises a semi-solid gel configured to allow transmission of an optical image therethrough; and
at least two supporting elements spaced from each other and positioned exterior to the attachment section and extending laterally away from the attachment section or the visualization section, and the at least two supporting elements are dimensioned to contact an internal surface of the lumen to substantially maintain a position of the optical coupler within a center of the lumen.
However, Leiner teaches the visualization section (fig. 2, element 30, [0020], image guide 30) comprises a main body (fig. 2, element 30, [0020], image guide 30) with an interior portion (fig. 2, element 32, [0020], image conduit 32), wherein at least the interior portion of the main body comprises a semi-solid gel (fig. 2, element 36, [0020], index matching material 36 such as a gel) configured to allow transmission of an optical image therethrough.
However, Ouchi teaches of an optical coupler (fig. 35, element 526) comprising at least two supporting elements spaced from each other (fig. 35, element 626) and positioned exterior to the attachment section, distal to the endoscope (fig. 34, element 5a, the distal surface of the scope terminates proximal to the bosses 626), and extending laterally away from the attachment section or the visualization section ([0138]), and the at least two supporting elements are dimensioned to contact an internal surface of the lumen to substantially maintain a position of the optical coupler within a center of the lumen ([0141] bosses 626 have a height of 1-3mm, therefore in a lumen sized to have 2-6mm of clearance to the scope, the scope would be stabilized in the center of the lumen).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupler of Reydel to include a gel as taught in Leiner in order to reduce Fresnel reflections between image transmission surfaces (Leiner [0020]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupler of Reydel to include a plurality of stabilizing projections as taught in Ouchi in order to interact with colonic creases (Ouchi [0146]).
Regarding claim 3, Reydel in view of Ouchi and Leiner teaches The optical coupler of claim 1,
Further, Ouchi teaches the coupler wherein the at least two supporting elements extend laterally away from the attachment section ([0141], bosses 626 extend laterally to height h26).
Regarding claim 5, Reydel, in view of Ouchi and Leiner teaches the optical coupler of claim 1, and Reydel further discloses wherein the endoscope comprises a tube with a longitudinal axis (Reydel: 120, Fig. 2, [0031]).
Ouchi further teaches the coupler wherein the at least two supporting elements extending at an angle transverse to the longitudinal axis of the elongate flexible shaft ([0141], bosses 626 extend laterally to height h26).
Regarding claim 6, Reydel, in view of Ouchi and Leiner, teaches the optical coupler of claim 1, and Reydel further discloses wherein the visualization section includes an outer surface extending distal to the distal end of the endoscope (Reydel: 210, Fig. 2, [0031]).
Regarding claim 9, Reydel in view of Ouchi and Leiner teaches the optical coupler of claim 6, and Reydel further discloses wherein a portion of the outer surface is within a field of view of the optical imaging system when the attachment section is mounted at the distal end of the optical imaging system (Reydel: 210, Fig. 2, [0031]).
Regarding claim 12, Reydel in view of Ouchi and Leiner teaches the optical coupler of claim 1, and Reydel further discloses wherein the attachment section is integral with the visualization section (Reydel: Fig. 2).
Regarding claim 13, Reydel in view of Ouchi and Leiner teaches the optical coupler of claim 12, and Reydel further discloses wherein the visualization section is distal of the attachment section when the attachment section is coupled to the distal end of the endoscope (Reydel: 210, 218, Fig. 2, [0032]).
Regarding claim 14, Reydel in view of Ouchi and Leiner teaches the optical coupler of claim 1, and Reydel further discloses wherein the visualization section has a central opening overlying at least a portion of the lens of the endoscope when the attachment section is coupled to the distal end of the endoscope (Reydel: 210, Fig. 2, [0031]).
Regarding claim 15, Reydel discloses an optical imaging system for visualizing a surface area in a patient, the system comprising:
an endoscope having an elongate flexible shaft with proximal and distal end (120, Fig. 2, [0031]) and a lens at the distal end of the shaft (122, Fig. 2, [0032]), wherein the shaft is configured for advancement through a lumen within the patient (120, Fig. 2, [0031]); and
an optical coupler comprising:
an attachment section (218, Fig. 2, [0032]) removably coupled to the distal end of the endoscope ([0032]);
a visualization section (210, Fig. 2, [0031]) in contact with the attachment section (Fig. 2, [0032]) and at least partially surrounding a distal surface of the endoscope (Fig. 2),
Reydel fails to expressly teach the visualization section comprises a main body with an interior portion, wherein at least the interior portion of the main body comprises a semi-solid gel configured to allow transmission of an optical image therethrough; and
at least two supporting elements spaced from each other and positioned exterior to the attachment section and extending laterally away from the attachment section or the visualization section, wherein the at least two supporting elements are dimensioned to contact an internal surface of the lumen to substantially maintain a position of the optical coupler within a center of the lumen.
However, Leiner teaches the visualization section (fig. 2, element 30, [0020], image guide 30) comprises a main body (fig. 2, element 30, [0020], image guide 30) with an interior portion (fig. 2, element 32, [0020], image conduit 32), wherein at least the interior portion of the main body comprises a semi-solid gel (fig. 2, element 36, [0020], index matching material 36 such as a gel) configured to allow transmission of an optical image therethrough.
However, Ouchi teaches of an optical imaging system comprising: an optical coupler (fig. 35, element 526) comprising: at least two supporting elements spaced from each other (fig. 35, element 626) and positioned exterior to the attachment section, distal to the endoscope (fig. 34, element 5a, the distal surface of the scope terminates proximal to the bosses 626) and extending laterally away from the attachment section or the visualization section ([0138]), and the at least two supporting elements are dimensioned to contact an internal surface of the lumen to substantially maintain a position of the optical coupler within a center of the lumen ([0141] bosses 626 have a height of 1-3mm, therefore in a lumen sized to have 2-6mm of clearance to the scope, the scope would be stabilized in the center of the lumen).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupler of Reydel to include a gel as taught in Leiner in order to reduce Fresnel reflections between image transmission surfaces (Leiner [0020]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupler of Reydel to include a plurality of stabilizing projections as taught in Ouchi in order to interact with colonic creases (Ouchi [0146]).
Regarding claim 17, Reydel in view of Ouchi and Leiner teaches optical imaging system of claim 15.
Further, Ouchi teaches the system wherein the at least two supporting elements extend laterally away from the attachment section ([0141], bosses 626 extend laterally to height h26).
Regarding claim 19, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 15.
Further, Ouchi teaches the system wherein the at least two supporting elements extending at an angle transverse to a longitudinal axis of the elongate flexible shaft ([0141], bosses 626 extend laterally to height h26).
Regarding claim 20, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 15, and Reydel further discloses wherein the visualization section includes an outer surface extending distal to the distal end of the endoscope (Reydel: 210, Fig. 2, [0031])
Regarding claim 21, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 15, and Reydel further discloses wherein the outer surface is spaced apart from the lens of the endoscope by a length equal to a reference distance selected from values in the depth of field distance range of the optical imaging system (Reydel: 210, Fig. 2, [0031]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have spaced apart the outer surface from the proximal surface by a length equal to a reference distance selected from values in the depth of field distance range of the optical imaging system. It would have been advantageous to make the combination in order to adjust the distances as measured from the leading end of the endoscope to an observed object, as is commonly known in the art. Additionally, it has been held that, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II A)).
Regarding claim 22, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 21, and Reydel further discloses wherein the reference distance is in the lower 10% of values in the depth of field distance range of the optical imaging system.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have spaced apart the outer surface from the proximal surface by a length equal to a reference distance selected from values in the depth of field distance range of the optical imaging system in order to adjust the distances as measured from the leading end of the endoscope to an observed object, as is commonly known in the art. For example, see Konno 5,555,129, Morita US 2004/0263613 and Breidenthal 7,621,868, wherein the reference distance is in the lower 10% of values in the depth of field distance range of the optical system, since it has been held that, “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”, (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (MPEP 2144.05 II A)).
Regarding claim 23, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 21, and Reydel further discloses wherein a portion of the outer surface is within a field of view of the lens when the attachment section is mounted at the distal end of the endoscope (Reydel: 210, Fig. 2, [0031]).
Regarding claim 26, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 15, and Reydel further discloses wherein the attachment section is integral with the visualization section (Reydel: 210, 218, Fig. 2).
Regarding claim 27, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 26, and Reydel further discloses wherein the visualization section is distal of the attachment section when the attachment section is coupled to the distal end of the endoscope (Reydel: 210, Fig. 2, [0031]).
Regarding claim 28, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 15, and Reydel further discloses wherein the visualization section has a central opening overlying at least a portion of the lens of the endoscope when the attachment section is coupled to the distal end of the endoscope (Reydel: 210, Fig. 2, [0031]).
Claim(s) 2, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reydel in view of Ouchi and Leiner as applied to claims 1, 15 above, and further in view of Saadat (WO 2007147060 A2).
Regarding claim 2, Reydel in view of Ouchi and Leiner teaches The optical coupler of claim 1,
Reydel in view of Ouchi and Leiner does not explicitly teach the coupler wherein the at least two supporting elements are elastic.
However, Saadat teaches the coupler wherein the at least two supporting elements (fig. 14a, element 214) are elastic ([0169]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupler of Reydel to include elastic supporting elements as taught in Saadat in order to allow the supports to expand or deploy given a particular configuration (Saadat [0169]).
Regarding claim 16, Reydel in view of Ouchi and Leiner teaches The optical coupler of claim 15,
Reydel in view of Ouchi and Leiner does not explicitly teach the coupler wherein the at least two supporting elements are elastic.
However, Saadat teaches the coupler wherein the at least two supporting elements (fig. 14a, element 214) are elastic ([0169]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupler of Reydel to include elastic supporting elements as taught in Saadat in order to allow the supports to expand or deploy given a particular configuration (Saadat [0169]).
Claim(s) 11, 25, 29, and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reydel in view of Ouchi and Leiner as applied to claims 1, 15 and further in view of U.S. Patent No. 5,078,681 to Kawashima.
Regarding claim 11, Reydel in view of Ouchi and Leiner teaches the optical coupler of claim 1.
Reydel in view of Ouchi and Leiner fails to expressly teach wherein the elastic material(s) are selected from the group consisting of silicone elastomers, silicone gels, albumin based gels, mineral oil based gels, epoxies, polyurethane, polyisoprene, polybutadiene, crosslinked polysiloxane, polyvinyl alcohol, poly(hydroxyethyl methacrylate), polyethylene glycol, poly(methacrylic acid), and mixtures thereof.
However, Kawashima teaches of an analogous device (Kawashima: Fig. 1) wherein the elastic material(s) are selected from the group consisting of silicone elastomers (Kawashima: Col. 3, lines 25-33).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Reydel, in view of Miyoshi, so that the elastic material(s) are selected from the group consisting of silicone elastomer, as taught by Kawashima. It would have been advantageous to make the combination for the purpose of having a thinner material (Col. 3, lines 25-33 of Kawashima).
Regarding claim 25, Reydel in view of Ouchi and Leiner teaches the optical imaging system of claim 15.
Reydel in view of Ouchi and Leiner fails to expressly teach wherein the elastic material(s) are selected from the group consisting of silicone elastomers, silicone gels, albumin based gels, mineral oil based gels, epoxies, polyurethane, polyisoprene, polybutadiene, crosslinked polysiloxane, polyvinyl alcohol, poly(hydroxyethyl methacrylate), polyethylene glycol, poly(methacrylic acid), and mixtures thereof.
However, Kawashima teaches of an analogous device (Kawashima: Fig. 1) wherein the elastic material(s) are selected from the group consisting of silicone elastomers (Kawashima: Col. 3, lines 25-33).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Reydel, in view of Miyoshi, so that the elastic material(s) are selected from the group consisting of silicone elastomer, as taught by Kawashima. It would have been advantageous to make the combination for the purpose of having a thinner material (Col. 3, lines 25-33 of Kawashima).
Regarding claim 29, Reydel in view of Ouchi and Leiner teaches the optical coupler of claim 1, and Reydel further discloses wherein the visualization section comprises one or more material(s) capable of transmitting an optical image of a surface area (Reydel: 210, Fig. 2, [0028]).
Reydel, in view of Ouchi and Leiner, fails to expressly teach one or more elastic material(s), wherein the one or more elastic materials has an index of refraction of 1.3 to 1.7.
However, Kawashima teaches of an analogous device including one or more elastic material(s), wherein the one or more elastic materials has an index of refraction of 1.3 to 1.7 (Kawashima: Col. 3, lines 25-33).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Reydel, in view of Miyoshi. to utilize one or more elastic materials has an index of refraction of about 1.3 to about 1.7, as taught by Kawashima. It would have been advantageous to make the combination for the purpose of having a thinner material (Col. 3, lines 25-33 of Kawashima).
Regarding claim 30, Reydel in view of Ouchi and Leiner and Kawashima teaches the optical coupler of claim 29.
Further, Kawashima teaches of an analogous device including one or more elastic material(s), wherein the index of refraction is 1.4 to 1.5 (Kawashima: Col. 3, lines 25-33).
Claims 10 and 24 is rejected under 35 U.S.C. 103 as being unpatentable over Reydel in view of Ouchi and Leiner as applied to claims 1, 15 and further in view of U.S. Publication No. 2010/0026940 to Takegami.
Regarding claim 10, Reydel, in view of Ouchi and Leiner, teaches the optical coupler of claim 1.
Reydel, in view of Ouchi and Leiner, fails to expressly teach the wherein the elastic material(s) have a durometer of from 40-95 on the Shore 00 scale.
However, Takegami teaches of an elastic material wherein the elastic material preferably has a durometer of from 40-95 on the Shore 00 scale (Takegami: [0202]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastic material of Reydel, in view of Miyoshi, so that it has a durometer of from 40-95 on the Shore 00 scale, as taught by Takegami. It would have been advantageous to make the combination in order to produce good surface smoothness ([0190] of Takegami), and since it has been held that, the selection of a known material based upon its suitability for the intended use is a design consideration with the skill of the art (see MPEP 2144.07).
Regarding claim 24, Reydel, in view of Ouchi and Leiner, teaches the optical imaging system of claim 15.
Reydel, in view of Ouchi and Leiner, fails to expressly teach the wherein the elastic material(s) have a durometer of from 40-95 on the Shore 00 scale.
However, Takegami teaches of an elastic material wherein the elastic material preferably has a durometer of from 40-95 on the Shore 00 scale (Takegami [0202]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the elastic material of Reydel, in view of Miyoshi, so that it has a durometer of from 40-95 on the Shore 00 scale, as taught by Takegami. It would have been advantageous to make the combination in order to produce good surface smoothness ([0190] of Takegami), and since it has been held that, the selection of a known material based upon its suitability for the intended use is a design consideration with the skill of the art (see MPEP 2144.07).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Moriyama (WO 03065884 A1).
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/TIMOTHY TUAN LUU/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795