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 amendments to claims 1, 25, and 34 in the response filed on 11/26/2025 are acknowledged.
Claims 1, 2, 4, 6, 8-14, 23, and 25-36 remain pending in the application
Claims 3, 5, 7, 15-22 and 24 are cancelled.
Claims 1, 2, 4, 6, 8-14, 23, and 25-36 are examined.
Response to Arguments
The applicant’s arguments have been considered but are moot in view of the new grounds of rejection necessitated by the applicant’s amendments to the claims. The applicant has modified claims 1, 25, and 34 to require “the surgical tool comprising a pair of pivoting jaws located at a distal end of the shaft in a fixed axial position relative to the handpiece”, and “wherein the cable extends from within the shaft, through a bore in the exterior surface of the shaft and to an exterior of the shaft to connect to the light generator” limitations heretofore not presented for examination in this application. As such, the scope of the claims was substantially changed and new grounds for rejection are presented.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2, recites “the surgical tool comprises an ablator selected from the group consisting of a thermal-ablator, a cryo-ablator, an electro-ablator and an ultrasonic-ablator”, but claim 1 already recites “the surgical tool comprising a pair of pivoting jaws”. The examiner suggests clarifying the claims to incorporate language such as in [0026] of Applicant’s spec, stating “In examples, surgical tool 30 can comprise forceps, a cutting tool, an ablation electrode, a cryogenic needle or applicator, an ultrasonic probe tip and the like, and combinations thereof”
Appropriate correction is required.
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.
Claim(s) 1, 2, 4, 5, 8, 9, 14, 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0157920 to Vayser et al. (hereinafter “Vayser”) in view of U.S. Publication No. 2019/0008603 to Hansen et al. (hereinafter “Hansen”).
Regarding claim 1, Vayser discloses a device for performing a surgical procedure, the device comprising: a shaft extending from a proximal portion to a distal portion along a longitudinal axis (202, Fig. 2B, [0042]); a handpiece connected to the proximal portion (204, Fig. 2B, [0041]) in a fixed axial position relative to the shaft ([0044] -The optical waveguide 202 may be fixedly attached to the handle 204 or it may be adjustably attached thereto, the examiner notes that Vayser teaches a fixed attachment); a surgical tool connected to a distal end of the distal portion (214, Fig. 2B, [0042]); a lumen extending through the shaft from the proximal portion to the surgical tool (Fig. 2B);a light conductor extending into the proximal portion and at least partially through the shaft ([0077]); a light emitter connected to the light conductor to emit light from the light conductor toward the surgical tool (302, Fig. 3A, [0047]); and a light generator coupled to the light conductor (306, Fig. 3A, [0047]); wherein the light emitter is positioned and oriented to emit light from the shaft to project the light distally onto the surgical tool (302, Fig. 3A, [0047]); wherein the light emitter is in a fixed axial position relative to the surgical tool and the handpiece(302, Fig. 3A, [0047]), the fixed position being proximal of the surgical tool (302, Fig. 3A, [0047]).
Vayser fails to expressly teach the surgical tool comprising a pair of pivoting jaws located at a distal end of the shaft in a fixed axial position relative to the handpiece
However, Hansen teaches of a device (Hansen: Fig. 1) including a surgical tool connected to a distal end of the distal portion (Hansen: 2, Fig. 1, [0134]), the surgical tool comprising a pair of pivoting jaws located at a distal end of the shaft in a fixed axial position relative to the handpiece (Hansen: 2, Fig. 1, [0134]).
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 Vayser so that the surgical tool is a pair of pivoting jaws, as taught by Hansen. It would have been advantageous to make the combination for the purpose of performing a surgical procedure ([0003] of Hansen).
Regarding claim 2, Vayser, in view of Hansen, teaches the device of claim 1, and Vayser further discloses wherein the surgical tool comprises an instrument for treating tissue, wherein the surgical tool comprises an ablator selected from the group consisting of a thermal-ablator, a cryo-ablator, an electro-ablator and an ultrasonic-ablator (214, Fig. 2B, [0042]).
Regarding claim 4, Vayser, in view of Hansen, teaches the device of claim 1, wherein the surgical tool comprises an optical device for viewing tissue ([0079])
Regarding claim 6, Vayser, in view of Hansen, teaches the device of claim 1, and Vayser further discloses further comprising: a switch located on the handpiece to selectively operate the light generator (1504, 1506 , 1508, Fig. 15, [0049]), wherein the light generator is within the handpiece or between the handpiece and the distal portion (306, Fig. 3A, [0047]).
Regarding claim 8, Vayser, in view of Hansen, teaches the device of claim 1, and Vayser further discloses wherein:the light conductor comprises an optical fiber; and the light emitter comprises an end surface of the optical fiber ([0077]).
Regarding claim 9, Vayser, in view of Hansen, teaches discloses the device of claim 1, and Vayser further discloses wherein the light conductor is outside of the lumen ([0077]) and the light emitter is located on an exterior of the shaft proximal of the surgical tool (302, Fig. 3A, [0047]).
Regarding claim 14, Vayser, in view of Hansen, teaches the device of claim 10, and Vayser further discloses further comprising: multiple channels extending along the tubular body; and a light conductor disposed in respective ones of the multiple channels (Fig. 3A).
Regarding claim 36, Vayser, in view of Hansen, teaches the device of claim 1, and Vayser further discloses further comprising: a lever connected to the handpiece ([0068]); and a cable extending from the lever at the handpiece, through the shaft and to the surgical tool (43, Fig. 5, [0142]).
Claim(s) 25, 26, 29-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0157920 to Vayser et al. (hereinafter “Vayser”) in view of U.S. Publication No. 2006/0069313 to Couvillon et al. (hereinafter “Couvillon”).
Regarding claim 25, Vayser discloses a device for performing a surgical procedure, and Vayser further discloses the device comprising: a shaft extending from a proximal portion to a distal portion along a longitudinal axis (202, Fig. 2B, [0042]); a handpiece connected to the proximal portion;a surgical tool connected to a distal end of the distal portion (204, Fig. 2B, [0041]); a cable extending at least partially through the shaft ([0077]); and a light generator connected to the cable (306, Fig. 3A, [0047]), the light generator positioned on the shaft proximate the distal end (306, Fig. 3A, [0047]); wherein the light generator is disposed radially outward of an outer surface of the shaft to project distally alongside the outer surface and onto the surgical tool ([0047]- Alternative embodiments have LEDs positioned more distally located along the extended shaft).
Vayser fails to expressly teach and wherein the cable extends from within the shaft, through a bore in the outer surface of the shaft and to an exterior of the shaft to connect to the light generator.
However, Couvillon teaches of a device (Couvillon: 20, Fig. 2, [0022]) wherein the cable extends from within the shaft, through a bore in the outer surface of the shaft and to an exterior of the shaft to connect to the light generator (Couvillon: 248, Fig. 7, ([0043]).
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 Vayser to utilize a cable and bore in the manner as taught by Couvillon. It would have been advantageous to make the combination for the purpose of providing light (Couvillon: [0043]).
Regarding claim 26, Vayser, in view of Couvillon, teaches the device of claim 25, and Vayser further discloses further comprising a light emitter connected to the light generator (302, Fig. 3A, [0047]), the light emitter configured to emit light toward the surgical tool (302, Fig. 3A, [0047]).
Regarding claim 29, Vayser, in view of Couvillon, teaches the device of claim 26, and Vayser further discloses further comprising: an additional light emitter to emit light toward the surgical tool (302, Fig. 3A, [0047]); wherein the additional light emitter is disposed on the shaft (302, Fig. 3A, [0047]).
Regarding claim 30, Vayser, in view of Couvillon, teaches the device of claim 29, and Vayser further discloses wherein: the shaft has a longitudinal axis (202, Fig. 2B, [0042]); and the additional light emitter is oriented in a different circumferential direction on the shaft than the light emitter (302, Fig. 3A, [0047]).
Regarding claim 31, Vayser, in view of Couvillon, teaches the device of claim 26, and Vayser further discloses wherein the cable comprises a light conductor connecting the light generator and the light emitter ([0077]).
Regarding claim 32, Vayser, in view of Couvillon, teaches the device of claim 31, and Vayser further discloses further comprising: a lumen extending through the shaft (Fig. 3A); wherein the light conductor extends at least partially in the lumen and the light emitter comprises an end of the light conductor ([0077]).
Claim(s) 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vayser in view of Couvillon and further in view of U.S. Publication No. 2019/0008603 to Hansen et al. (hereinafter “Hansen”).
Regarding claim 27, Vayser, in view of Couvillon, teaches the device of claim 26.
Vayser, in view of Couvillon, fails to expressly teach wherein: the shaft has an end cap at the distal portion; and the light emitter is disposed more proximal than the end cap.
However, Hansen teaches of a device (Fig. 1) wherein: the shaft (Hansen: 4a, Fig. 1, [0136]) has an end cap (Hansen: 4a’, Fig. 1, [0136]) at the distal portion (Hansen: Fig. 1); and the light emitter (Hansen: 4, Fig. 1, [0136]) is disposed more proximal than the end cap (Hansen: Fig. 1 – the examiner notes that the proximal end of the light emitter is proximal to the distal end of the end cap).
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 Vayser, in view of Couvillon, to utilize an end cap, as taught by Hansen. It would have been advantageous to make the combination for the purpose of generating light ([0136] of Hansen).
Regarding claim 28, Vayser in view of Couvillon and Hansen, teaches the device of claim 27.
Vayser in view of Couvillon and Hansen, fails to expressly teach further comprising:an additional light emitter to emit light toward the surgical tool;wherein the additional light emitter is disposed on the end cap.
However, Hansen further teaches an additional light emitter (Hansen: 84, Fig. 13, [0153]) to emit light (Hansen:87a, 87b, Fig. 13, [0153]) toward the surgical tool (Hansen:: 82, Fig. 13, [0153]).wherein the light emitter (Hansen:4, Fig. 1, [0136]) is disposed on the end cap (Hansen:4a’, Fig. 1, [0136]).
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 end cap of the device of Vayser in view of Couvillon and Hansen, to include an additional light emitter, as taught by Hansen. It would have been advantageous to make the combination for the purpose of informing a surgeon using the surgical instrument assembly about the relative position of the object to the gripping space ([0153] of Hansen).
Claim(s) 10, 11, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0157920 to Vayser et al. (hereinafter “Vayser”) and Couvillon and further in view of U.S. Publication No. 2016/0120395 to Qi.
Regarding claim 10, Vayser, teaches the device of claim 1.
Vayser, in view of Couvillon, fails to expressly teach wherein the shaft comprises: a tubular body defining the lumen, the tubular body comprising: an inner wall; an outer wall; and a channel extending along the tubular body to receive the light conductor.
However, Qi teaches of a device (Qi: Fig. 6) wherein the shaft (Qi: 2, Fig. 6, [0036]) comprises: a tubular body defining the lumen (Qi: 2, Fig. 6, [0036]), the tubular body comprising: an inner wall (Qi: Fig. 6); an outer wall (Qi: Fig. 6); and a channel extending along the tubular body to receive the light conductor (Qi: 23, Fig. 6, [0042]).
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 Vayser, in view of Couvillon, to include a shaft, as taught by Qi. It would have been advantageous to make the combination for the purpose of using more than one surgical instrument in surgery ([0042] of Qi).
Regarding claim 11, Vayser, in view of Couvillon and Qi, teaches the device of claim 10.
Vayser, in view of Couvillon and Qi, fails to expressly teach wherein the channel comprises a groove in the outer wall, wherein: the shaft has a circular cross-sectional area; the lumen has a circular cross-sectional area centered within the shaft; the groove has a V-shaped cross-sectional area; and the groove does not impinge on the lumen.
However, Qi further teaches wherein the channel comprises a groove in the outer wall (Qi: 23, Fig. 6, [0042]), wherein: the shaft has a circular cross-sectional area (Qi: Fig. 6); the lumen has a circular cross-sectional area centered within the shaft (Fig. 6); the groove has a V-shaped cross-sectional area (Qi: 23, Fig. 6, [0042]); and the groove does not impinge on the lumen (Qi: 23, Fig. 6, [0042]).
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 Vayser, in view of Couvillon and Qi, to utilize the channel, as taught by Qi. It would have been advantageous to make the combination for the purpose of using more than one surgical instrument in surgery ([0042] of Qi).
Regarding claim 12, Vayser, in view of Couvillon and Qi, teaches the device of claim 11.
Vayser, in view of Couvillon and Qi, fails to expressly teach further comprising a sheath at least partially surrounding the tubular body to secure the light conductor in the groove, wherein the channel is less than a thickness between the inner wall and the outer wall.
However, Qi further teaches further comprising a sheath at least partially surrounding the tubular body to secure the light conductor in the groove, wherein the channel is less than a thickness between the inner wall and the outer wall (Qi: 26, Fig. 6, [0036]).
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 Vayser, in view of and Couvillon Qi, to utilize a sheath, as taught by Qi. It would have been advantageous to make the combination for the purpose of using more than one surgical instrument in surgery ([0042] of Qi).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vayser and Couvillon and Qi and further in view of U.S. Publication No. 2017/0056055 to Truckai.
Regarding claim 13, Vayser, in view of Couvillon and Qi, teaches the device of claim 10.
Vayser, in view of Couvillon and Qi, fails to expressly teach wherein the channel comprises a passageway between the inner wall and the outer wall.
However, Truckai teaches of a device (Truckai: 100, Fig. 1, [0034]) wherein the channel comprises a passageway between the inner wall and the outer wall (Truckai: 132, Fig. 2, [0035]).
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 Vayser, in view of Couvillon and Qi, so that the channel comprises a passageway between the inner wall and the outer wall, as taught by Truckai. It would have been advantageous to make the combination for the purpose of performing surgery on the patient ([0018] of Truckai).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable U.S. Publication No. 2016/0045277 to Vayser et al. (hereinafter “Vayser”) and Couvillon and further in view of U.S. Publication No. 2015/0103140 et al. (hereinafter “Kotsuk”).
Regarding claim 23, Vayser and Couvillon teaches the device of claim 1.
Vayser, in view of Couvillon, fails to expressly teach wherein the light generator is releasably attached to an exterior of the handpiece.
However, Kostuk teaches of a device (Kostuk: 600, Fig. 12, [0080]) teaches wherein the light generator (Kostuk: 660, Fig. 12, [0080]) is releasably attached to an exterior of the handpiece (Kostuk: 670, Fig. 12, [0080]).
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 Vayser, in view of Couvillon, to utilize the light generator, as taught Kostuk. It would have been advantageous to make the combination for the purpose of swapping compatible respective modules of differing specifications for particular imaging applications ([0080] of Kostuk).
Claim(s) 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vayser and Couvillon and further in view U.S. Publication No. 2014/0066911 to Nau.
Regarding claim 33, Vayser, in view of Couvillon, teaches the device of claim 31, and Vayser further discloses further comprising: a lumen (Vayser: [0057]) extending through the shaft (Fig. 2A); wherein the light conductor extends at least partially through the lumen (Vayser: [0056]) and has a distal portion protruding through an exterior sidewall of the shaft to connect to the light emitter (Vayser: Fig. 2a).
Vayser, in view of Couvillon, fails to expressly teach a lens comprising the light emitter.
However, Nau teaches of a device (Nau: 20, Fig. 1, [0037]) including a lens comprising the light emitter (Nau: 406a, Fig. 4A, [0060]).
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 Vayser, in view of Couvillon, to utilize a lens comprising the light emitter, as taught by Nau. It would have been advantageous to make the combination in order to direct the light beam to the tissue ([0061] of Nau).
Claim(s) 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2016/0157920 to Vayser et al. (hereinafter “Vayser”) in view of U.S. Publication No. 2006/0069313 to Couvillon et al. (hereinafter “Couvillon”) and U.S. Publication No. 2019/0008603 to Hansen et al. (hereinafter “Hansen”).
Regarding claim 34, Vayser discloses a device for performing a surgical procedure, the device comprising: a shaft extending from a proximal portion to a distal portion (202, Fig. 2B, [0042]), the shaft extending along a longitudinal axis(202, Fig. 2B, [0042]); a handpiece connected to the proximal portion in a fixed axial position relative to the shaft (204, Fig. 2B, [0041]-[0044] -The optical waveguide 202 may be fixedly attached to the handle 204 or it may be adjustably attached thereto, the examiner notes that Vayser teaches a fixed attachment)); a surgical tool connected to a distal end of the distal portion, (214, Fig. 2B, [0042]); a lumen extending through the shaft from the proximal portion to the surgical tool (Fig. 2B); a cable extending into the proximal portion and at least partially through the shaft ([0077]); and a light generator coupled to the cable and positioned in the handpiece (306, Fig. 3A, [0044]- LEDs in the handle , [0047]); and a light emitter (302, Fig. 3A, [0047]) mounted radially outward of an exterior surface of the shaft relative to the longitudinal axis in a fixed position relative to the surgical tool and the handpiece (302, Fig. 3A, [0047]), the fixed position being proximal of the surgical tool (Fig. 3A); wherein light from the light generator is positioned and oriented to project distally onto the surgical tool (302, Fig. 3A, [0047]).
Vayser fails to expressly teach wherein the surgical tool comprising a pair of pivoting jaws located at a distal end of the shaft and being located in a fixed axial position on the shaft relative to the handpiece, wherein the cable extends from within the shaft, through a bore in the exterior surface of the shaft and to an exterior of the shaft to connect to the light generator.
However, Hansen teaches of a device (Hansen: Fig. 1) including a surgical tool connected to a distal end of the distal portion (Hansen: 2, Fig. 1, [0134]), the surgical tool comprising a pair of pivoting jaws located at a distal end of the shaft in a fixed axial position relative to the handpiece (Hansen: 2, Fig. 1, [0134]).
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 Vayser so that the surgical tool is a pair of pivoting jaws, as taught by Hansen. It would have been advantageous to make the combination for the purpose of performing a surgical procedure ([0003] of Hansen).
Vayser, in view of Hansen fails to expressly teach wherein the cable extends from within the shaft, through a bore in the outer surface of the shaft and to an exterior of the shaft to connect to the light generator.
However, Couvillon teaches of a device (Couvillon: 20, Fig. 2, [0022]) wherein the cable extends from within the shaft, through a bore in the outer surface of the shaft and to an exterior of the shaft to connect to the light generator (Couvillon: 248, Fig. 7, ([0043]).
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 Vayser to utilize a cable and bore in the manner as taught by Couvillon. It would have been advantageous to make the combination for the purpose of providing light (Couvillon: [0043]).
Regarding claim 35, Vayser, in view of Couvillon, teaches the device of claim 34, and Vayser further discloses further comprising: a light conductor extending from the light generator to the distal portion of the shaft ([0077]), the light conductor extending at least partially through the shaft ([0077]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTEN A. SHARPLESS whose telephone number is (571)272-2387. The examiner can normally be reached Monday-Tuesday 6:00 AM - 2:00 PM, and Friday 6:00 AM - 10:00 AM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mike Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.A.S./Examiner, Art Unit 3795 /MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
Prosecution Insights