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 .
Claim Interpretation
It is noted that MPEP 608.01(m) addresses the use of reference characters in the claims and holds that “Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims. The reference characters, however, should be enclosed within parentheses so as to avoid confusion with other numbers or characters which may appear in the claims. Generally, the presence or absence of such reference characters does not affect the scope of a claim.” In the instant case, the Examiner is not interpreting the presence of the reference characters in the claim as having a limiting effect on either of the scope or broadest reasonable interpretation of the claims.
Response to Amendment
The Amendment filed November 26, 2025 has been entered. Applicant’s amendments have overcome the claim objection and the 112(b) rejections previously set-forth in the Non-Final Office mailed on 08/27/2025. Currently, claims 1, 3-4, 9, 13-15, and 17 have been amended, claims 18-19 have been newly added, and claims 1-15, and 17-19 are pending in the application.
Claim Rejections - 35 USC § 102
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 1-4, 8-10, 13-15, and 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer (U.S. Application No. 20140378961 A1).
Regarding independent claims 1 and 17, Fischer discloses an apparatus (11), comprising:
a body (12) configured for attachment to an exterior of a surgical instrument (56) by a user of the surgical instrument without use of a tool, the body configured to extend at least partially around the exterior of the surgical instrument or instrument component when attached thereto (pa. 0038 & Fig. 1);
As seen in the cross-section of the apparatus in Fig. 5, the surgical instrument is nestled/attached to the recessed cavity/indentation of a distal portion of the apparatus’ body without the additional assistance of any external tool. The claim language is broad and does not specifically describe what tool(s) may not be utilized to assist attaching the surgical instrument to the body of the apparatus. Furthermore, the Specification of the instant application describes, “the connection of the light receiving device with the surgical instrument by means of the apparatus is preferably possible without tools. The apparatus can be preferably plugged on the instrument or, at least partly, pushed into the instrument [Emphasis added by Examiner, pa. 0010]. Therefore, Examiner will be interpreting the claim language “a body configured for attachment to an exterior of a surgical instrument by a user of the surgical instrument without use of a tool” as any attachment style between two components which does not involve the assistance of an external tool/device.
Fischer further discloses a light receiving device (i.e., optical fibers 31, 33) operably coupled to the body (pa. 0042 & Fig. 5), wherein the light receiving device comprises a light inlet (18, 19, 20, 21) (pa. 0038) at a distal end of the light receiving device (Figs. 2-3) configured for receiving light created during use of the surgical instrument, the light receiving device configured to transmit the received light proximally to a light analysis device (17) (pa. 0043, 0054 & Fig. 23);
wherein the light inlet faces a working section (i.e., a distal section of the electrode probe) of an electrode (13) of the surgical instrument when the apparatus is attached to the surgical instrument (see Figs. 1-3);
wherein the light inlet has a light acceptance angle (18a, 20a) and the body is configured such that a distal end of the electrode (13) of the surgical instrument is located inside the light acceptance angle of the light inlet when the apparatus is attached to the surgical instrument (pa. 0040 & Figs. 3, 17);
wherein the light created during use of the surgical instrument is created by the electrode (pa. 0045).
Regarding claim 2, Fischer discloses wherein the body is configured to be attached to the surgical instrument (pa. 0038) such that the light receiving device has one single spatial position or a plurality of predefined spatial positions relative to the surgical instrument.
Examiner is highlighting the fact that the light receiving device (i.e., optical fibers) extend from the distal portion of the surgical instrument (as seen in Fig. 5) to the proximal end of the cable (15). Therefore, at the distal end, the light receiving device has one spatial position relative to the surgical instrument (since it is embedded within the structure of the surgical instrument), but in the light receiving device portion that is inside the cable, there exists a plurality of predefined spatial positions relative to the surgical instrument as the user moves the apparatus during surgery.
Regarding claim 3, Fischer discloses wherein the electrode (13) is configured to be supplied with electrical RF energy (pa. 0038), wherein the body of the apparatus is configured to be attached to the surgical instrument (pa. 0038) such that the light receiving device has one single spatial position (pa. 0042) or a plurality of predefined spatial positions relative to the electrode (pa. 0038).
Examiner is highlighting the fact that the light receiving device (i.e., optical fibers) extend from the distal portion of the surgical instrument (as seen in Fig. 5) to the proximal end of the cable (15). Therefore, at the distal end, the light receiving device has one spatial position relative to the electrode (since it is embedded within the structure of the surgical instrument that also holds the electrode), but in the light receiving device portion that is inside the cable, there exists a plurality of predefined spatial positions relative to the electrode as the user moves the apparatus during surgery.
Regarding claim 4, Fischer discloses wherein the body of the apparatus is configured to support the electrode (13) and is configured to be attached to the surgical instrument (pa. 0038) such that the light receiving device has one single spatial position (pa. 0042) or a plurality of predefined spatial positions relative to the electrode (pa. 0038).
Examiner is highlighting the fact that the light receiving device (i.e., optical fibers) extend from the distal portion of the surgical instrument (as seen in Fig. 5) to the proximal end of the cable (15). Therefore, at the distal end, the light receiving device has one spatial position relative to the electrode (since it is embedded within the structure of the surgical instrument that also holds the electrode), but in the light receiving device portion that is inside the cable, there exists a plurality of predefined spatial positions relative to the electrode as the user moves the apparatus during surgery.
Regarding claim 8, Fischer discloses wherein the body of the apparatus comprises a flushing channel (36, 40), wherein the flushing channel is configured to output a flushing medium that laterally passes the light inlet of the light receiving device (pa. 0047 & Figs. 13-14).
Regarding claim 9, Fischer discloses wherein the body of the apparatus comprises a flushing channel (36, 40), wherein the body defines a spatial position of the flushing channel relative to the light receiving device (pa. 0047 & Figs. 13-14) such that the inlet is oriented to receive light created by the electrode (pa. 0045).
Regarding claim 10, Fischer discloses disclose wherein the light inlet of the light receiving device is arranged inside the body of the apparatus when the light receiving device is attached to the surgical instrument.
Examiner is interpreting the word “inside” as partially/fully or directly/indirectly situated with the boundaries or confines of. As shown in Figure 5, the light inlets (18, 20) are situated within the circumferential boundaries of the distal end of the light receiving device, wherein the proximal portion of the surgical instrument (56, or section 28 as seen in the figure) is situated inside the apparatus. Therefore, the light inlet is indirectly situated inside with the boundaries or confines of the apparatus.
Regarding claim 13, Fischer discloses a channel section (see dashed circles on annotated Fig. 14 below) limited on one side by a wall (see arrow in annotated Fig. 14) and configured to be limited on another side by a first longitudinal side (see arrow in annotated Fig. 14) of the electrode, wherein the channel section is configured to be flushed with a flushing medium (with the aid of nozzle (42)) (pa. 0047), wherein the channel section is configured such that a second longitudinal side (see arrow in annotated Fig. 14) of the electrode opposite the first longitudinal side, is exposed at least in sections along the channel section (i.e., bottom channel) when the light receiving device is attached to the surgical instrument.
Regarding claim 14, Fischer discloses wherein an optical axis (i.e., a center axis of the light acceptance angle) being oriented at an acute angle (via prism 38) with respect to a longitudinal axis of the electrode of the surgical instrument when the surgical instrument is attached to the apparatus (pa. 0047, 0052 & Figs. 17-19).
Regarding claim 15, Fischer discloses a method of using the apparatus (11) of claim 1, comprising attaching the light receiving device (i.e., optical fibers 31, 33) (pa. 0038, 0042 & Figs. 1-5) on the surgical instrument (16) during a surgery of with the apparatus (pa. 0038).
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Regarding claim 18, Fischer discloses wherein the body comprises a distal end portion (i.e., distal-most region/surface of the body, see Fig. 5) that defines a channel or recess (i.e., recessed/indented structure as seen in the cross-section of Fig. 5) configured for receiving a distal end of the surgical instrument (pa. 0038 & Fig. 5).
Regarding claim 19, Fischer discloses wherein the body comprises a distal end portion (i.e., distal-most region/surface of the body as seen in Fig. 5) comprising an opening (i.e., lumen which allows passage for electrical line 29 and a proximal portion/section of the electrode, pa. 0042 & Fig. 5) for allowing the electrode of the surgical instrument to extend therethrough.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer, as applied in claim 1 above, and further in view of Vayser (U.S. Application No. 20180078301 A1).
Regarding claim 5, Fischer discloses wherein the body comprises a mount (i.e., hollow distal circumferential portion of the body (12) which receives coupling piece (28) of the surgical instrument, as seen in Fig. 5) configured to limit movement of the surgical instrument in the mount (pa. 0042), wherein the mount is configured to hold the surgical instrument in the axial direction (see Figs. 1-5).
However, Fischer does not disclose wherein the mount allows for movement of the surgical instrument in an axial direction, nor wherein the mount is configured to include a device for subsequent definition or limitation of an axial position of the surgical instrument in the mount.
Vayser, in the same field of endeavor, teaches an apparatus (10) comprising a handle (204, analogous to the body of Fischer) and a cylindrical structure (202, analogous to the surgical instrument of Fischer) (pa. 0047 & Fig. 2A), wherein the handle further comprises a mount (i.e., hollow distal circumferential portion of the handle that receives the cylindrical structure, as seen in Fig. 2A. This is analogous to the mount structure of Fischer). The cylindrical structure may be fixedly attached to the handle or it may be adjustably attached in order to allow movement of the cylindrical structure in an axial direction (pa. 0050 & Figs. 2B-2C), wherein the mount includes a device (i.e., a collet, a threaded connection, a pin and detent mechanism, a spring-loaded mechanism, a ratchet and pawl mechanism) for subsequent definition or limitation of an axial position of the surgical instrument in the mount (pa. 0050).
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 coupling piece of the surgical instrument of Fischer to be adjustably attached to the mount in order to move in an axial direction as taught by Vayser for the purpose of providing a necessary length that accommodates the size of the electrode (Vayser, pa. 0050). Furthermore, it would have been obvious to modify the mount of Fischer to include a device as taught by Vayser in order to allow further and specific adjustment of the length of the coupling piece of the surgical device (Vayser, pa. 0050).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer and Vayser, as applied in claims 1 and 5 above, and further in view of Jako (U.S. Patent No. 6346106 B1).
Regarding claim 6, Fischer/Vayser combination disclose the invention substantially as claimed in claims 1 and 5 discussed above.
However, they do not explicitly disclose wherein the device comprises a section that is movable transverse to the axial direction, wherein the section is configured to engage the surgical instrument by a lateral movement of the section after arrangement of the instrument in the mount in order to define or limit the axial position of the surgical instrument in the mount.
Jako, in the same field of endeavor, teaches a surgical instrument (102) comprising an electrode (114) and a controlling mechanism including a rachet wheel (326) and a lever (329) (analogous to the device of Vayser, i.e., the ratchet and pawl mechanism) (Col. 5, lines 56-667 – Col. 6, lines 1-4 & Fig. 5). Furthermore, Jako teaches wherein the ratchet wheel further comprises a section (i.e., the lever) that is movable transverse to the axial direction, wherein the section is configured to engage the surgical instrument by a lateral movement of the section (i.e., up and down as the wheel rotates).
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 substituted the ratchet and pawl mechanism with the rachet wheel and a lever configuration of Jako because they are both known equivalents in the art and they would yield the same predictable results of mechanically moving a component.
Regarding claim 7, Fischer/Vayser combination disclose the invention substantially as claimed in claims 1 and 6 discussed above.
However, they do not disclose wherein the section is attached to the mount via a resilient transition portion.
Jako, in the same field of endeavor, teaches wherein the section is attached to the mount via a resilient transition portion (i.e., a spring) (Col. 5, lines 56-667 – Col. 6, lines 1-4 & Fig. 5).
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 substituted the ratchet and pawl mechanism with the rachet wheel and a lever configuration of Jako because they are both known equivalents in the art and they would yield the same predictable results of mechanically moving a component.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Fischer, as applied in claim 1 above, and further in view of Igarashi (E.P. Application No. 3195824 A1).
Regarding claims 11-12, Fischer discloses wherein the body of the apparatus comprises a flushing channel (36, 40), wherein the flushing channel is configured to output a flushing medium that laterally passes the light inlet of the light receiving device (pa. 0047 & Figs. 13-14).
However, Fischer does not disclose wherein the light inlet is arranged inside, or at least partially inside, the flushing channel when the light receiving device is attached to the surgical instrument.
Igarashi, in the same field of endeavor, teaches a medical device (1) comprising a fluid channel (19) (pa. 0099-0100 & Fig. 20) and a separate optical fiber channel (30) (pa. 0017). However, in an alternative embodiment, both channels may be configured as a single channel performing both functions (pa. 0107).
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 substituted the separate optical fiber/flushing channel embodiment of Fischer with a single channel as taught by Igarashi since they are both known equivalents and would yield the same predictable results of allowing space for an optic fiber and a flushing fluid.
Response to Arguments
Applicant's arguments filed 11/26/2025 have been fully considered but they are not persuasive.
With regards to newly amended independent claim 1, Applicant argues that the Fischer reference does not disclose the newly added limitation, “a body configured for attachment to an exterior of a surgical instrument (11) or to an exterior of an instrument component (12) of the surgical instrument (11) by a surgical user of the surgical instrument (11) without use of a tool, the body configured to extend at least partially around the exterior of the surgical instrument or instrument component when attached thereto (Emphasis added by Examiner). Specifically, Applicant asserts that, “the apparatus in accordance with claim 1 is configured to be attached to an existing surgical instrument without use of a tool by a user, such as a physician, when the obtaining tissue information by means of light analysis is desired”. However, Examiner respectfully disagrees.
The Fischer reference discloses an apparatus (11), comprising a body (12) configured for attachment to an exterior of a surgical instrument (56) by a user of the surgical instrument without use of a tool, the body configured to extend at least partially around the exterior of the surgical instrument or instrument component when attached thereto (pa. 0038 & Fig. 1). As seen in the cross-section of the apparatus in Fig. 5, the surgical instrument is nestled/attached to the recessed cavity/indentation of a distal portion of the apparatus’ body without the additional assistance of any external tool. Applicant has failed to point out to Examiner in the Remarks specifically what tool(s) are disclosed in the Fischer reference which may be interpreted as assisting to attach the surgical instrument to the body of the apparatus. Furthermore, the Specification of the instant application describes, “the connection of the light receiving device with the surgical instrument by means of the apparatus is preferably possible without tools. The apparatus can be preferably plugged on the instrument or, at least partly, pushed into the instrument [Emphasis added by Examiner, pa. 0010]. Therefore, the claim language is still broad enough to be interpreted as any attachment style between two components which does not involve the assistance of an external tool. Therefore, the rejection is maintained.
With respect to newly added dependent claims 18-19, Applicant argues that the Fischer reference does not disclose the limitations of the claims. However, Examiner disagrees.
Fischer discloses wherein the body comprises a distal end portion (i.e., distal-most region/surface of the body, see Fig. 5) that defines a channel or recess (i.e., recessed/indented structure as seen in the cross-section of Fig. 5) configured for receiving a distal end of the surgical instrument (pa. 0038 & Fig. 5). Fischer further discloses wherein the body comprises a distal end portion (i.e., distal-most region/surface of the body as seen in Fig. 5) comprising an opening (i.e., lumen which allows passage for electrical line 29 and a proximal portion/section of the electrode, pa. 0042 & Fig. 5) for allowing the electrode of the surgical instrument to extend therethrough. Therefore, for the reasons set-forth above, the rejection of Fischer is sustained.
Applicant has further argued with respect to independent claim 17 on page 10 of the Remarks. These arguments are unpersuasive for substantially the same rationale as set forth above with respect to independent claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Benaron (US 5807261 A) teaches a tool for nondestructive interrogation of the tissue including a light source emitter and detector which may be mounted directly on the surgical too.
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.
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794