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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 20, 2025 has been entered.
Disposition of Claims
Claims 1, 5 & 8-20 are pending and rejected.
Claims 2-4 & 6-7 are canceled.
Response to Arguments
Applicant’s arguments, see Page 4, filed November 20, 2025, with respect to the rejections under 35 U.S.C. § 112(b) of Claims 1, 5 & 8-20 have been fully considered and are persuasive.
The rejections under 35 U.S.C. § 112(b) of Claims 1, 5 & 8-20 have been withdrawn.
Applicant’s arguments, see Pages 4-5, filed November 20, 2025, with respect to the rejections under 35 U.S.C. § 103 of Claims 1, 5 & 8-20 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 5, 8-16 & 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Takahashi (WO 2017/150154 A1) in view of Bala (US 2009/0264706).
Regarding Claim 1, Takahashi, as best understood, discloses an integrated disposable tissue visualization device with off axis viewing (Fig. 1, 1; [0014]), comprising:
an elongate rigid tubular probe (Fig. 1, 2; [0014]), extending along a longitudinal axis between a proximal end and a distal end (Fig. 2, O; [0022]);
a camera (Fig. 3, 39; [0024]);
an illumination element (Fig. 3, 32; [0022]);
a prism (Fig. 3, 35; [0023]); and
a sled (Fig. 3, 11c; [0022]) configured to receive the camera and the prism (see Fig. 3),
wherein the sled comprises a distal angled surface at a distal end (an angled prism-receiving surface disposed at a distal end portion of 11c; see Fig. 3), the angled surface configured to receive the prism (the angled prism-receiving surface interfaces with an angled surface of 35; see Fig. 3),
wherein the prism provides off-axis viewing of a target tissue at an angle (see Fig. 3); and
wherein the prism comprises high index of refraction material of at least 2.0 ([0029]).
Takahashi fails to explicitly disclose wherein the angle of off-axis viewing is at a range of about 25 degrees to about 30 degrees.
However, Bala teaches a visualization device with off axis viewing (Fig. 5A, 16; [0032]), comprising:
an elongate rigid tubular probe (Fig. 5A, 20; [0034]), extending along a longitudinal axis between a proximal end and a distal end (see Fig. 5A);
a prism (Fig. 5A, 50; [0035]); and
a sled (Fig. 5B, 70; [0036]) configured to receive the prism ([0036]),
wherein the prism provides off-axis viewing of a target tissue at an angle range of about 25 degrees to about 30 degrees (Fig. 5A, 50 can have an angle of 30° or an angle of 45°; [0040]), and
wherein the prism comprises high index of refraction material ([0040]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to replace the right-angled prism as disclosed by Takahashi, with the 30° angled prism taught by Bala, as various off-axis prisms are known to be interchangeable based only the requirements of a given procedure (Bala; [0031]).
Regarding Claim 5, Takahashi, as previously modified by Bala, teaches the device of Claim 1. Takahashi further discloses wherein the camera is positioned within an enclosed area of the sled (see Fig. 3).
Regarding Claim 8, Takahashi, as previously modified by Bala, teaches the device of Claim 1. Takahashi further discloses wherein the prism comprises an angled surface configured to be positioned on the angled surface of the sled (an angled surface of 35; see Fig. 3).
Regarding Claim 9, Takahashi, as previously modified by Bala, teaches the device of Claim 8. Takahashi further discloses wherein a slope of the angled surface of the prism is substantially similar a slope of the angled surface of the sled (the angled surface of 35 and the angled prism-receiving surface of 11c are substantially the same slope; see Fig. 3).
Regarding Claim 10, Takahashi, as previously modified by Bala, teaches the device of Claim 1. Takahashi further discloses wherein the sled (Fig. 3, 11c; [0022]), the camera (Fig. 3, 39; [0024]), and a potted housing (Fig. 3, 11d; [0027]) form a cylindrical assembly (Fig. 3, 11; [0014]).
Regarding Claim 11, Takahashi, as previously modified by Bala, teaches the device of Claim 1. Takahashi further discloses the sled and a potted housing form a cylindrical assembly with the camera positioned therein (see Fig. 3).
Regarding Claim 12, Takahashi, as previously modified by Bala, teaches the device of Claim 11. Takahashi further discloses wherein the distal angled surface of the sled comprises an angled distal surface of the cylindrical assembly (11c is part of 11 and therefore the angled prism-receiving surface of 11c is an angled distal surface of 11; see Fig. 3).
Regarding Claim 13, Takahashi, as previously modified by Bala, teaches the device of Claim 12. Takahashi further discloses wherein the cylindrical assembly further comprises the prism ([0023]), wherein the prism is positioned on the angled distal surface of the cylindrical assembly (the angled prism-receiving surface of 11c, which is also the angled distal surface of 11 interfaces with the angled surface of 35; see Fig. 3).
Regarding Claim 14, Takahashi, as previously modified by Bala, teaches the device of Claim 13. Takahashi further discloses wherein the prism comprises a flat surface (Fig. 3, 34; [0023]) configured to form a flat distal end of the cylindrical assembly (Fig. 2, 11a; [0020]).
Regarding Claim 15, Takahashi, as previously modified by Bala, teaches the device of Claim 11. Takahashi further discloses wherein the cylindrical assembly is positioned at the distal end of the elongate rigid tubular probe ([0014]).
Regarding Claim 16, Takahashi, as previously modified by Bala, teaches the device of Claim 11. Takahashi further discloses wherein the illumination element is positioned circumferentially around the cylindrical assembly (c of 32 is positioned circumferentially about O of 11; see Fig. 3).
Regarding Claim 18, Takahashi, as previously modified by Bala, teaches the device of Claim 1. Takahashi further discloses wherein the illumination element comprises an illumination fiber or light emitting diodes ([0025]).
Regarding Claim 19, Takahashi, as previously modified by Bala, teaches the device of Claim 1. Takahashi further discloses wherein the prism is configured to refract an image of the target tissue to be received by the camera ([0017] & [0023]).
Regarding Claim 20, Takahashi, as previously modified by Bala, teaches the device of Claim 1. Takahashi further discloses wherein the target tissue comprises an orthopedic joint (Fig. 1, 1 is an endoscope and is therefore capable of being an arthroscope; [0014]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi (WO 2017/150154 A1) in view of Bala (US 2009/0264706) as applied to Claim 11 above, and further in view of Yamaya (US 2020/0037861).
Regarding Claim 17, Takahashi, as previously modified by Bala, teaches the device of Claim 11. Takahashi, as previously modified by Bala, fails to explicitly disclose a covering that surrounds the cylindrical assembly.
However, Yamaya teaches an off-axis viewing visualization device (Fig. 1, 12 wherein 12 is a side-facing endoscope; [0030] & [0038]) comprising:
an elongate rigid tubular probe (Fig. 1, 15; [0033]), extending along a longitudinal axis between a proximal end and a distal end (see Fig. 1); and
a cylindrical assembly (Fig. 5, 16; [0033]) comprising:
an optical system (Fig. 5, 28; [0035]); and
an illumination system (Fig. 5, 27; [0035]); and
a covering (Fig. 5, 17; [0033]) that surrounds the cylindrical assembly ([0033]).
The advantage of the disposable covering is to reduce a risk of infection by minimizing the portions of the endoscope that need to be cleaned and sterilized (Yamaya; [0012]).
Therefore, it would have been obvious before the effective filing date of the claimed invention to someone with ordinary skill in the art to modify the cylindrical assembly as disclosed by Takahashi, as previously modified by Bala, to include the disposable covering taught by Yamaya, to reduce a risk of infection by minimizing the portions of the endoscope that need to be cleaned and sterilized (Yamaya; [0012]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN FLOYD LONDON whose telephone number is (571)272-4478. The examiner can normally be reached Monday - Friday: 10:00 am ET - 6:00pm ET.
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/STEPHEN FLOYD LONDON/Examiner, Art Unit 3795
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795