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 .
Response to Amendment
The amendment filed on 8/6/2026 has been entered. Claims 1-5, 11-16, and 18-25 remain pending in the application. Claims 5 and 18 remain withdrawn. Applicant’s amendments to the Drawings and Claims have overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 5/6/2026.
Response to Arguments
Applicant’s arguments, see pages 11-14, filed 8/6/2026, with respect to claim 1 have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 102 rejection identified in the non-final dated 5/6/2026 moot, and require a new ground of rejection.
Therefore, the 102 rejection previously identified in the non-final action dated 5/6/2026 has been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see pages 14-15, filed 8/6/2026, with respect to claim 16 have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 102 rejection identified in the non-final dated 5/6/2026 moot, and require a new ground of rejection.
Therefore, the 102 rejection previously identified in the non-final action dated 5/6/2026 has been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Applicant’s arguments, see pages 15-16, filed 8/6/2026, with respect to claim 20 have been fully considered and are persuasive in light of Applicant’s amendments. Applicant amended the independent claim with newly added limitations. Such newly added limitations change the scope of the claims, render the previous 103 rejection identified in the non-final dated 5/6/2026 moot, and require a new ground of rejection.
Therefore, the 103 rejection previously identified in the non-final action dated 5/6/2026 has been withdrawn.
However, upon further search and consideration, a new ground of rejection is made. Please see section 35 USC § 103 below for further explanation.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “outermost portion” and “innermost portion” of the sheath in claim 25 must be shown or the feature(s) canceled from the claim(s). The drawings are objected to under 37 CFR 1.83(a) for failing to illustrate the claimed arrangement of the first lumen and the second lumen positioned between the inner wall and the outer wall of the sheath, as recited in claim 21. The drawings should be amended to illustrate the claimed features, including the positioning of the first lumen and the second lumen relative to the inner wall and the outer wall of the sheath. Examiner notes that a transverse cross-sectional view could help illustrate the arrangement. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, line 6, “includes distal opening at a distal end of the electrode” should read “includes a distal opening at a distal end of the electrode.” This suggested modification would improve the antecedent basis for the claim limitation.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 25 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 recites the limitation "the sheath includes an innermost portion and an outermost portion” in lines 1-2. The recitation of “an innermost portion and the outermost portion are each formed of the light-emitting optical fiber” in lines 2-3 render the scope of the claim unclear. Specifically, it is unclear what structural components of the sheath constitute the innermost portion and the outermost portion and how each of these portions is formed of the light-emitting optical fiber. Furthermore, the claim recites a non-light-emitting material positioned between the innermost portion and the outermost portion, but it is unclear how the recited portions and intervening material are structurally arranged to form the claimed sheath. Accordingly, the structural configuration of the sheath and the relationship to the light-emitting optical fiber cannot be reasonably ascertained.
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.
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.
The present rejection(s) reference specific passages from cited prior art. However, Applicant is advised that the rejections are based on the entirety of each cited prior art. That is, each cited prior art reference “must be considered in its entirety”. (See MPEP 2141.02(VI)) Therefore, Applicant is advised to review all portions of the cited prior art if traversing a rejection based on the cited prior art
Claims 1-2, 11-12, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Appl. Publ. No. 2023/0270494 A1 to Shi et al. (“Shi”) in view of U.S. Patent Appl. Publ. No. 2010/0041986 A1 to Nguyen et al. (“Nguyen”).
Regarding claim 1, Shi discloses a medical device (‘endoscope’; Fig. 1A, [0098]), comprising:
an insertion portion, including a shaft that includes a sheath (‘endoscope body 401 of endoscope’; Fig. 1A and 8C, [0102]) and an electrode (the electrical treatment part (including, but is not limited to, an endoscopic submucosal dissection (ESD) knife 222; Fig. 8C, [0100]), wherein the sheath includes a sheath lumen (‘instrument passage 403 of the endoscope’; Figs. 2-3; [0098]), wherein the electrode is positioned within at least a distal portion of the sheath (Fig. 8C).
However, Shi does not explicitly disclose wherein the electrode includes an electrode lumen extending longitudinally through a central portion of the electrode, wherein the electrode lumen includes distal opening at a distal end of the electrode, and wherein the electrode is configured to deliver energy to a target site;
a light-emitting optical fiber configured to deliver light to the target site, wherein at least a portion of the light-emitting optical fiber is positioned within the sheath or the electrode lumen; and
a light-receiving optical fiber configured to receive light from the target site through the distal opening of the electrode lumen, wherein at least a portion of the light-receiving optical fiber is positioned within the electrode lumen, wherein the light-receiving optical fiber terminates at the distal opening of the electrode lumen, and wherein a distal end of the light-emitting optical fiber is spaced apart from a distal end of the light-receiving optical fiber.
Nguyen teaches a medical device (‘catheter 110’; Fig. 1-2, [0025]), comprising:
an insertion portion, including a shaft that includes a sheath (‘an elongated tubular catheter body 230’; Fig. 2, [0025]) and an electrode (‘the distal region of the catheter 110 includes a tip electrode 402’; Fig. 4A, [0028]), wherein the sheath includes a sheath lumen (lumen through which wires 408, 410, 412 run through; Fig. 4A), wherein the electrode is positioned within at least a distal portion of the sheath (‘the distal region of the catheter 110 includes a tip electrode 402’; Fig. 4A, [0028]), wherein the electrode includes an electrode lumen extending longitudinally through a central portion of the electrode (central lumen indicated by broken lines; Fig. 4C, [0030]), wherein the electrode lumen includes distal opening at a distal end of the electrode (‘the catheter distal region 24 also includes one or more openings … 330’; Fig. 4A, [0026]), and wherein the electrode is configured to deliver energy to a target site (‘the catheter tip 340 may be fabricated from suitable biocompatible materials to conduct ablation energy, such as RF energy’; Fig. 4A, [0027]);
a light-emitting optical fiber configured to deliver light to the target site (‘a light beam from a high-speed swept laser travels through the optical fiber 601 and enters optical switch 602 which, in accordance with the digital control signal received from the data acquisition card 614, selects one of the five optical fibers 604.sub.i, i=0, … 4, and directs the light beam to the selected optical fiber 604.sub.j.’; Figs. 4A and 6; [0045]), wherein at least a portion of the light-emitting optical fiber is positioned within the sheath or the electrode lumen (the distal region of the catheter includes … a plurality of optical fibers 604.sub.i, i=0, … N; Fig. 4A, [0028]); and
a light-receiving optical fiber configured to receive light from the target site through the distal opening of the electrode lumen (‘the reflected light from an imaging object near the distal tip of the catheter 110 and the reflected light from the selected fiber end face, which is the reference beam, travel back in the same selected optical fiber toward the optical circulator 606.sub.j that is associated with the selected optical fiber 604.sub.j.; Figs. 4A and 6, [0045]), wherein at least a portion of the light- receiving optical fiber is positioned within the electrode lumen (central optical fiber 604; Fig. 4A), wherein the light- receiving optical fiber terminates at the distal opening of the electrode lumen (‘a plurality of optical fibers 604.sub.i, i=0, …, N, terminating at a plurality of openings or transparent windows 330’; Fig. 4A, [0028]), and wherein a distal end of the light-emitting optical fiber is spaced apart from a distal end of the light-receiving optical fiber (the optical fibers 604 are spaced apart from each other; Fig. 4A).
Nguyen is considered to be analogous to the claimed invention because it is in the same field of medical devices with an electrode disposed within the lumen. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated light-receiving and light-emitting optical fibers within a lumen of the electrode and within the sheath in the medical device of Shi, as taught by Nguyen, to increase the functionality of the medical device of Shi by enabling the collection and transmission of received light for optical sensing and/or imaging.
Regarding claim 2, Shi, as previously modified by Nguyen, discloses a medical device according to claim 1. Shi further discloses wherein the electrode has a "T" shaped cross-section with an electrode shaft and a widened distal portion (‘the head part 2221 may be a needle knife or may be a T-shaped knife, a star-shaped knife, provided that the head part is applicable to ESD surgery’; Fig. 7A-B, [0151]), wherein a portion of the electrode extends distally of the sheath lumen in both an extended configuration (Fig. 7B) and a retracted configuration (Fig. 7A) of the electrode, and wherein the widened distal portion is wider than an opening of the sheath lumen (the head part 221 is wider than an opening of the lumen; Fig. 7A-B).
Regarding claim 11, Shi, as previously modified by Nguyen, discloses a medical device according to claim 1. Nguyen further teaches wherein the medical device includes a handle (‘the catheter 110 comprises a control unit body 210’; Fig. 2, [0025]), wherein the light-emitting optical fiber extends from the handle through a portion of the shaft to deliver light to the target site (the OCT system 600 comprises an optical fiber 601 … which are connected via the fiber optic connector 270 to the five corresponding optical fibers which terminate inside the catheter 110; Figs. 2 and 6; [0044]).
Regarding claim 12, Shi, as previously modified by Nguyen, discloses a medical device according to claims 1 and 11. Nguyen further teaches wherein the handle of the medical device includes a port (fiber optic connector 270; Fig. 2, [0044]), wherein the port is coupled to a light source that provides light to the light-emitting optical fiber (‘a light beam from a high-speed swept laser travels through the optical fiber 601 and enters optical switch 602 which, in accordance with the digital control signal received from the data acquisition card 614, selects one of the five optical fibers 604.sub.i, i=0, … 4, and directs the light beam to the selected optical fiber 604.sub.j.’; Figs. 2 and 6; [0045]).
Regarding claim 24, Shi, as previously modified by Nguyen, discloses a medical device according to claim 1. Shi further discloses wherein the electrode is movably positioned within the sheath lumen (the ESD knife 222 is movably positioned within the sheath lumen; Figs. 7A-B), such that the electrode is extendable (Fig. 7B) and retractable (Fig. 7A) relative to a distal end of the sheath.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen, as applied to claim 1 above, and further in view of U.S. Patent Appl. Publ. No. 2023/0270322 A1 to Bala (“Bala”).
Regarding claim 3, Shi, as previously modified by Nguyen, discloses a medical device according to claim 1. However, Shi, as modified by Nguyen, does not explicitly disclose wherein at least a portion of the sheath is configured to convey light and form the light-emitting optical fiber.
Bala teaches wherein at least a portion of the sheath is configured to convey light and form the light-emitting optical fiber (‘the endoscope uses a cylinder of high index, high transmission polymer, cyclic polyolefin as the high index core material and air as the low refractive index cladding, providing the same total internal reflection phenomena as with glass fiber optics’; Fig. 1, [0041]). Bala teaches that the sheath can provide for increasing the light output of the light source and expanding the area of illumination ([0041]).
Bala is considered to be analogous to the claimed invention because it is in the same field of medical devices configured to perform illumination. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a portion of the sheath that is configured to convey light and form the light-emitting optical fiber in the medical device of Shi, as taught by Bala, to increase the functionality of the medical device of Shi by increasing the light output of the light source and expanding the area of illumination, as recognized by Bala.
Regarding claim 4, Shi, as previously modified by Nguyen and Bala, discloses a medical device according to claims 1 and 3. However, Shi, as modified by Nguyen and Bala, does not explicitly disclose wherein a distal end of the sheath includes a first width, wherein a distal end of the electrode includes a second width, and wherein the second width is less than the first width, such that the distal end of the electrode does not block a path of light emission from the distal end of the sheath.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the width of the distal end of the electrode of Shi to be less than the width of the distal end of the sheath of Shi since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the electrode and sheath would not operate differently with the claimed diameters.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen, as applied to claims 1 and 11 above, and further in view U.S. Patent Appl. Publ. No. 2019/0110838 A1 to Martinez et al. (“Martinez”).
Regarding claim 13, Shi, as previously modified by Nguyen, discloses a medical device according to claims 1 and 11. However, Shi, as modified by Nguyen, does not explicitly disclose wherein the light-receiving optical fiber extends through the electrode lumen, through a shaft lumen, to the handle, and to a processor, wherein the processor analyzes light received by the light-receiving optical fiber to generate a light profile.
Martinez teaches wherein the light-receiving optical fiber extends through the electrode lumen, through a shaft lumen, to the handle, and to a processor (the control unit 14 may also include a light emitter 44 and light receiver 45 that are in optical communication with and configured to transmit and receive, respectively, light through the optical fibers 62; Fig. 2, [0051]), wherein the processor analyzes light received by the light-receiving optical fiber to generate a light profile (the optical fibers 62 may be used to identify the type of tissue structure being interrogated by the device 12. Different tissues have different optical properties that may be detected by the device 12; [0062] and [0064]) (during and/or after the delivery of treatment or ablation energy, the optical fiber(s) 62 may be used to detect fluorescence from the tissue at the target treatment location, and the processing circuitry 92 may compare this in-treatment and/or post-treatment fluorescence to the pre-treatment or baseline fluorescence; [0067]).
Martinez is considered to be analogous to the claimed invention because it is in the same field of medical device systems with electrodes. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, to incorporate the teachings of Nguye, by configuring the optical fiber to connect to a processor configured to analyze light to generate a light profile. Doing so would be to identify the type of tissue structure being interrogated by the device, as recognized by Martinez.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen and Bala.
Regarding claim 16, Shi discloses a medical device (endoscope’; Fig. 1A, [0098]), comprising:
a handle (drive part 30; Fig. 1A);
an insertion portion, including a shaft that includes a sheath (‘endoscope body 401 of endoscope’; Fig. 1A and 8C, [0102]) and an electrode (the electrical treatment part (including, but is not limited to, an endoscopic submucosal dissection (ESD) knife 222; Fig. 8C, [0100]), wherein the sheath includes a sheath lumen (‘instrument passage 403 of the endoscope’; Figs. 2-3; [0098]), wherein the electrode is positioned within at least a distal portion of the sheath (Fig. 8C),
However, Shi does not explicitly disclose a handle including a port and a hub. Additionally, Shi does not explicitly disclose wherein the electrode includes an electrode lumen, and wherein the electrode is configured to deliver energy to a target site;
a light-emitting optical fiber configured to deliver light to the target site, wherein at least a portion of the light-emitting optical fiber is positioned within the sheath or the electrode lumen, and wherein at least a portion of the sheath is configured to convey light and form the light-emitting optical fiber; and
a light-receiving optical fiber configured to receive light from the target site, wherein at least a portion of the light-receiving optical fiber is positioned within the electrode lumen;
wherein at least the portion of the sheath is configured to direct optical energy distally from a distal end of the sheath toward the target site.
Nguyen teaches a medical device (‘catheter 110’; Fig. 1-2, [0025]), comprising:
a handle (a control unit body 210; Fig. 2, [0025]) including a port (‘fiber optic connector 270’; Fig. 2, [0025]) and a hub (‘an irrigation port 250’; Fig. 2, [0025]);
an insertion portion, including a shaft that includes a sheath (‘an elongated tubular catheter body 230’; Fig. 2, [0025]) and an electrode (‘the distal region of the catheter 110 includes a tip electrode 402’; Fig. 4A, [0028]), wherein the sheath includes a sheath lumen (lumen through which wires 408, 410, 412 run through; Fig. 4A), wherein the electrode is positioned within at least a distal portion of the sheath (‘the distal region of the catheter 110 includes a tip electrode 402’; Fig. 4A, [0028]), wherein the electrode includes an electrode lumen (central lumen indicated by broken lines; Fig. 4C, [0030]), and wherein the electrode is configured to deliver energy to a target site (‘the catheter tip 340 may be fabricated from suitable biocompatible materials to conduct ablation energy, such as RF energy’; Fig. 4A, [0027]);
a light-emitting optical fiber configured to deliver light to the target site (‘a light beam from a high-speed swept laser travels through the optical fiber 601 and enters optical switch 602 which, in accordance with the digital control signal received from the data acquisition card 614, selects one of the five optical fibers 604.sub.i, i=0, … 4, and directs the light beam to the selected optical fiber 604.sub.j.’; Figs. 4A and 6; [0045]), wherein at least a portion of the light-emitting optical fiber is positioned within the sheath or the electrode lumen (the distal region of the catheter includes … a plurality of optical fibers 604.sub.i, i=0, … N; Fig. 4A, [0028]); and
a light-receiving optical fiber configured to receive light from the target site (‘the reflected light from an imaging object near the distal tip of the catheter 110 and the reflected light from the selected fiber end face, which is the reference beam, travel back in the same selected optical fiber toward the optical circulator 606.sub.j that is associated with the selected optical fiber 604.sub.j.; Figs. 4A and 6, [0045]), wherein at least a portion of the light-receiving optical fiber is positioned within the electrode lumen (central optical fiber 604; Fig. 4A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a light-receiving and light-emitting optical fiber within a lumen of the electrode in the medical device of Shi, as taught by Nguyen, to increase the functionality of the medical device of Shi by enabling the collection and transmission of received light for optical sensing and/or imaging.
Furthermore, Bala teaches wherein at least a portion of the sheath is configured to convey light and form the light-emitting optical fiber (‘the endoscope uses a cylinder of high index, high transmission polymer, cyclic polyolefin as the high index core material and air as the low refractive index cladding, providing the same total internal reflection phenomena as with glass fiber optics’; Fig. 1, [0041]). Bala teaches that the sheath can provide for increasing the light output of the light source and expanding the area of illumination ([0041]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a portion of the sheath that is configured to convey light and form the light-emitting optical fiber in the medical device of Shi, as taught by Bala, to increase the functionality of the medical device of Shi by increasing the light output of the light source and expanding the area of illumination, as recognized by Bala.
Claims 21-23 is rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen, as applied to claims 1 above, and further in view U.S. Patent Appl. Publ. No. 2005/0203341 A1 to Welker et al. (“Welker”).
Regarding claim 21, Shi, as previously modified by Nguyen, discloses a medical device according to claim 1. However, Shi, as previously modified by Nguyen, does not explicitly disclose wherein the sheath includes an inner wall and an outer wall, wherein the sheath includes a first lumen and a second lumen, wherein the first lumen and the second lumen are each positioned between the inner wall and the outer wall, wherein at least a portion of the light-emitting optical fiber is positioned within the first lumen, and wherein the second lumen is configured for at least one of fluid delivery or suction.
Welker teaches wherein the sheath includes an inner wall (inner wall 148; Fig. 11) and an outer wall (outer wall 148; Fig. 11), wherein the sheath includes a first lumen (top right quadrant 150; Fig. 11) and a second lumen (smaller lumens 126; Fig. 11), wherein the first lumen and the second lumen are each positioned between the inner wall and the outer wall (smaller lumens 126 are positioned between the inner wall 148 and the outer wall 148; Fig. 11), wherein at least a portion of the light-emitting optical fiber is positioned within the first lumen (‘imaging guide endoscopic element 112 composed of a plurality of optical cores 114 encased in a common cladding 116; Fig. 11, [0081]), and wherein the second lumen is configured for at least one of fluid delivery or suction (‘each of these lumen endoscopic elements may serve as … fluid transfer channel’; Fig. 11, [0082]).
Welker is considered to be analogous to the claimed invention because it is in the same field of medical devices with an optical fiber imaging guide. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated a second lumen configured for at least one of fluid delivery or suction in the medical device of Shi, as taught by Welker, to increase the functionality of the medical device of Shi by enabling the delivery of fluid to a target treatment site. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the lumens of Shi, as modified by Nguyen, to match the configuration taught by Welker, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70.
Regarding claim 22, Shi, as previously modified by Nguyen and Welker, discloses a medical device according to claims 1 and 21. Welker further teaches wherein a distal opening of the second lumen is at least partially radially outside of the distal end of the electrode (the smaller lumen 126 is at least partially radially outside of the bigger, central lumen 126; Fig. 11).
Regarding claim 23, Shi, as previously modified by Nguyen and Welker, discloses a medical device according to claims 1 and 21. Welker further teaches wherein the inner wall defines the sheath lumen (larger central lumen 126; Fig. 11), and wherein the inner wall separates the sheath lumen from the first lumen and the second lumen (the inner wall 148 separates the larger central lumen 126 from the quadrants 150 and the smaller lumens 126; Fig. 11).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen and Martinez, as applied to claims 1, 11, and 13 above, and further in view U.S. Patent Appl. Publ. No. 2022/0110681 A1 to Angle et al. (“Angle”).
Regarding claim 14, Shi, as previously modified by Nguyen and Martinez, discloses a medical device according to claims 1, 11, and 13. However, Shi, as previously modified by Nguyen and Martinez, does not explicitly disclose wherein based on the generated light profile, the processor is configured to deactivate the electrode.
Angle teaches wherein based on the generated light profile, the processor is configured to deactivate the electrode (if the probing beam detects a structure (e.g., a blood vessel) that is undesirable for ablation, the system may be configured to briefly blank (i.e., turn off) the ablation beam until the probing beam or the results from the probing indicate that the combined beams are no longer scanning over an undesirable structure; [0133]). Angle teaches that deactivating the electrode based on a light profile helps to limit ablation of blood vessels to avoid excessive bleeding ([0012]).
Angle is considered to be analogous to the claimed invention because it is in the same field of medical device systems with electrodes. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, as modified by Nguyen and Martinez, to incorporate the teachings of Angle by configuring the processor to deactivate the electrode based on the light profile. Doing so would be help to limit ablation of blood vessels to avoid excessive bleeding, as recognized by Angle.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen, Martinez, and Angle, as applied to claims 1, 11, and 13-14 above, and further in view U.S. Patent Appl. Publ. No. 2025/0352029 A1 to Tanigami et al. (“Tanigami”).
Regarding claim 15, Shi, as previously modified by Nguyen, Martinez, and Angle, discloses a medical device according to claims 1, 11, and 13-14. However, Shi, as modified by Nguyen, Martinez, and Angle, does not explicitly disclose wherein when the processor detects a red light the processor sends a signal to disable energization of the electrode.
Tanigami teaches wherein when the processor detects a red light (it is also possible to apply red light observation (RDI: Red Dichromatic Imaging) in which a biological tissue is irradiated with light in a green wavelength band and special light including light in an amber wavelength band and light in a red wavelength band, and a blood vessel and a bleeding portion in a deep portion such as mucosa can be grasped. In this case, the detector 923 detects the blood vessel region from the blood vessel recognition image of the red light observation image; Fig. 10, [0115]). The reflected red light detection is used to easily detect a blood vessel in a deep portion such as a mucosa ([0115]).
Tanigami is considered to be analogous to the claimed invention because it is in the same field of medical devices with a processor for generating a light profile. It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, as modified by Nguyen, Martinez, and Angle, to incorporate the teachings of Tanigami by configuring the processor to detect red light. Doing so would be help to easily detect a blood vessel in a deep portion such as a mucosa, as recognized by Tanigami.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen, Martinez, and Angle.
Regarding claim 20, Shi discloses a medical device (endoscope’; Fig. 1A, [0098]), comprising:
an insertion portion, including a sheath (‘endoscope body 401 of endoscope’; Fig. 1A and 8C, [0102]) and an electrode (the electrical treatment part (including, but is not limited to, an endoscopic submucosal dissection (ESD) knife 222; Fig. 8C, [0100]);
wherein the sheath includes a sheath lumen (‘instrument passage 403 of the endoscope’; Figs. 2-3; [0098]); and
wherein the electrode is positioned within at least a distal portion of the sheath lumen (Fig. 8C).
However, Shi does not explicitly disclose wherein the sheath includes one or more fluid delivery or suction application lumens;
wherein the electrode includes an electrode lumen extending longitudinally through a central portion of the electrode to a distal opening of the electrode lumen at a distal end of the electrode, and wherein the electrode is configured to deliver energy to a target site;
a light-emitting optical fiber configured to deliver light to the target site, wherein at least a portion of the light-emitting optical fiber is positioned within the sheath or the electrode lumen, and wherein the light-emitting optical fiber terminates at a distal end of the sheath; and
a light-receiving optical fiber configured to receive light from the target site through the distal opening of the electrode lumen, wherein at least a portion of the light-receiving optical fiber is positioned within the electrode lumen, and wherein the light- receiving optical fiber terminates at the distal opening of the electrode lumen; and
wherein the light-receiving optical fiber is coupled to a processor, wherein the processor analyzes light received by the light-receiving optical fiber to generate a light profile, wherein based on the light profile, the processor is configured to deactivate the electrode.
Nguyen teaches a medical device (catheter 110’; Fig. 1-2, [0025]), comprising:
an insertion portion, including a sheath (an elongated tubular catheter body 230’; Fig. 2, [0025]) and an electrode (‘the distal region of the catheter 110 includes a tip electrode 402’; Fig. 4A, [0028]);
wherein the sheath includes a sheath lumen (lumen through which wires 408, 410, 412 run through; Fig. 4A), wherein the sheath includes one or more fluid delivery or suction application lumens (the distal region of the catheter 110 includes … a fluid lumen 404 for irrigating fluid to elution holes 320; Fig. 4A, [0028]);
wherein the electrode is positioned within at least a distal portion of the sheath lumen (‘the distal region of the catheter 110 includes a tip electrode 402’; Fig. 4A, [0028]), wherein the electrode includes an electrode lumen extending longitudinally through a central portion of the electrode (central lumen indicated by broken lines; Fig. 4C, [0030]) to a distal opening of the electrode lumen at a distal end of the electrode (‘the catheter distal region 24 also includes one or more openings … 330’; Fig. 4A, [0026]), and wherein the electrode is configured to deliver energy to a target site (‘the catheter tip 340 may be fabricated from suitable biocompatible materials to conduct ablation energy, such as RF energy’; Fig. 4A, [0027]);
a light-emitting optical fiber configured to deliver light to the target site (‘a light beam from a high-speed swept laser travels through the optical fiber 601 and enters optical switch 602 which, in accordance with the digital control signal received from the data acquisition card 614, selects one of the five optical fibers 604.sub.i, i=0, … 4, and directs the light beam to the selected optical fiber 604.sub.j.’; Figs. 4A and 6; [0045]), wherein at least a portion of the light-emitting optical fiber is positioned within the sheath or the electrode lumen (the distal region of the catheter includes … a plurality of optical fibers 604.sub.i, i=0, … N; Fig. 4A, [0028]), and wherein the light-emitting optical fiber terminates at a distal end of the sheath (‘a plurality of optical fibers 604.sub.i, i=0, …, N, terminating at a plurality of openings or transparent windows 330’; Fig. 4A, [0028]); and
a light-receiving optical fiber configured to receive light from the target site through the distal opening of the electrode lumen (‘the reflected light from an imaging object near the distal tip of the catheter 110 and the reflected light from the selected fiber end face, which is the reference beam, travel back in the same selected optical fiber toward the optical circulator 606.sub.j that is associated with the selected optical fiber 604.sub.j.; Figs. 4A and 6, [0045]), wherein at least a portion of the light-receiving optical fiber is positioned within the electrode lumen (central optical fiber 604; Fig. 4A), and wherein the light- receiving optical fiber terminates at the distal opening of the electrode lumen (‘a plurality of optical fibers 604.sub.i, i=0, …, N, terminating at a plurality of openings or transparent windows 330’; Fig. 4A, [0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated light-receiving and light-emitting optical fibers within a lumen of the electrode and within the sheath in the medical device of Shi, as taught by Nguyen, to increase the functionality of the medical device of Shi by enabling the collection and transmission of received light for optical sensing and/or imaging. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated one or more fluid delivery lumens in the medical device of Shi, as taught by Nguyen, to increase the functionality of the medical device of Shi by enabling the delivery of fluids to the environment distal of the medical device.
Martinez further discloses wherein the light-receiving optical fiber is coupled to a processor (the control unit 14 may also include a light emitter 44 and light receiver 45 that are in optical communication with and configured to transmit and receive, respectively, light through the optical fibers 62; Fig. 2, paragraph 0051);
wherein the processor analyzes light received by the light-receiving optical fiber to generate a light profile (the optical fibers 62 may be used to identify the type of tissue structure being interrogated by the device 12. Different tissues have different optical properties that may be detected by the device 12; paragraph 0062 and 0064) (during and/or after the delivery of treatment or ablation energy, the optical fiber(s) 62 may be used to detect fluorescence from the tissue at the target treatment location, and the processing circuitry 92 may compare this in-treatment and/or post-treatment fluorescence to the pre-treatment or baseline fluorescence; paragraph 0067).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, to incorporate the teachings of Nguyen by configuring the optical fiber to connect to a processor configured to analyze light to generate a light profile. Doing so would be to identify the type of tissue structure being interrogated by the device, as recognized by Martinez.
Furthermore, Angle teaches wherein based on the generated light profile, the processor is configured to deactivate the electrode (if the probing beam detects a structure (e.g., a blood vessel) that is undesirable for ablation, the system may be configured to briefly blank (i.e., turn off) the ablation beam until the probing beam or the results from the probing indicate that the combined beams are no longer scanning over an undesirable structure; [0133]). Angle teaches that deactivating the electrode based on a light profile helps to limit ablation of blood vessels to avoid excessive bleeding ([0012]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, as modified by Nguyen and Martinez, to incorporate the teachings of Angle by configuring the processor to deactivate the electrode based on the light profile. Doing so would be help to limit ablation of blood vessels to avoid excessive bleeding, as recognized by Angle.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Shi in view of Nguyen and Bala, as applied to claim 16 above, and further in view of Martinez, Angle, and Tanigami.
Regarding claim 19, Shi, as previously modified by Nguyen and Bala, discloses a medical device according to claim 16. However, Shi, as modified by Nguyen and Bala, does not explicitly disclose wherein the light-receiving optical fiber is coupled to a processor; wherein the processor analyzes light received by the light-receiving optical fiber to generate a light profile, wherein, based on the light profile, the processor is configured to deactivate the electrode; wherein when the processor detects a red light, the processor sends a signal to disable energization of the electrode.
Martinez further discloses wherein the light-receiving optical fiber is coupled to a processor (the control unit 14 may also include a light emitter 44 and light receiver 45 that are in optical communication with and configured to transmit and receive, respectively, light through the optical fibers 62; Fig. 2, paragraph 0051);
wherein the processor analyzes light received by the light-receiving optical fiber to generate a light profile (the optical fibers 62 may be used to identify the type of tissue structure being interrogated by the device 12. Different tissues have different optical properties that may be detected by the device 12; paragraph 0062 and 0064) (during and/or after the delivery of treatment or ablation energy, the optical fiber(s) 62 may be used to detect fluorescence from the tissue at the target treatment location, and the processing circuitry 92 may compare this in-treatment and/or post-treatment fluorescence to the pre-treatment or baseline fluorescence; paragraph 0067).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, to incorporate the teachings of Nguyen and Bala by configuring the optical fiber to connect to a processor configured to analyze light to generate a light profile. Doing so would be to identify the type of tissue structure being interrogated by the device, as recognized by Martinez.
Furthermore, Angle teaches wherein based on the generated light profile, the processor is configured to deactivate the electrode (if the probing beam detects a structure (e.g., a blood vessel) that is undesirable for ablation, the system may be configured to briefly blank (i.e., turn off) the ablation beam until the probing beam or the results from the probing indicate that the combined beams are no longer scanning over an undesirable structure; [0133]). Angle teaches that deactivating the electrode based on a light profile helps to limit ablation of blood vessels to avoid excessive bleeding ([0012]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, as modified by Nguyen, Bala, and Martinez, to incorporate the teachings of Angle by configuring the processor to deactivate the electrode based on the light profile. Doing so would be help to limit ablation of blood vessels to avoid excessive bleeding, as recognized by Angle.
Finally, Tanigami teaches wherein when the processor detects a red light (it is also possible to apply red light observation (RDI: Red Dichromatic Imaging) in which a biological tissue is irradiated with light in a green wavelength band and special light including light in an amber wavelength band and light in a red wavelength band, and a blood vessel and a bleeding portion in a deep portion such as mucosa can be grasped. In this case, the detector 923 detects the blood vessel region from the blood vessel recognition image of the red light observation image; Fig. 10, [0115]). The reflected red light detection is used to easily detect a blood vessel in a deep portion such as a mucosa ([0115]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the medical device of Shi, as modified by Nguyen, Bala, Martinez, and Angle, to incorporate the teachings of Tanigami by configuring the processor to detect red light. Doing so would be help to easily detect a blood vessel in a deep portion such as a mucosa, as recognized by Tanigami.
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.
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/OLIVIA GRACE STARKEY/ Examiner, Art Unit 3795
/MICHAEL J CAREY/ Supervisory Patent Examiner, Art Unit 3795
