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 .
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.
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.
Claims 1-4 and 6-12 are 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 1 recites the limitation "the distal face of the jaw liner" in the last line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-4 and 6-12 are rejected since they are dependent upon an indefinite base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 and 6-12 are rejected under 35 U.S.C. 103 as being unpatentable over Shelton et al. (US 2017/0202609) in view of Sarley et al. (US 2021/0196334).
Regarding claim 1, Shelton discloses an end effector assembly of a surgical instrument (see Figs. 40-43), comprising: an ultrasonic blade adapted to receive ultrasonic energy to vibrate the ultrasonic blade and adapted to connect to a source of electrosurgical energy (see ultrasonic blade 1006, Figs. 40-41 and 43, [0275] and [0282]), the ultrasonic blade defining a distal face (see outward facing surface of the distal end of blade 1006, Figs. 40-41 and 43); and a jaw member movable relative to the ultrasonic blade from a spaced-apart position to an approximated position for clamping tissue therebetween (see jaw member 1014, Figs. 40-41), the jaw member including: a structural body having a body portion (see 1020) and a distal cap portion (see distal tip of 1022), at least a portion of the distal cap portion of the structural body defining an electrode (see electrode 1022) adapted to connect to the source of electrosurgical energy at a potential different from a potential of the ultrasonic blade (see [0282]); and a jaw liner engaged within the body portion of the structural body and extending therefrom towards the ultrasonic blade (see pad 1024) such that, in the approximated position, the jaw liner contacts the ultrasonic blade to define a gap distance between the electrode and the distal face of the ultrasonic blade to facilitate bipolar electrosurgical tissue treatment upon conduction of bipolar energy between the electrode and the distal face of the ultrasonic blade and through tissue in contact therewith (see [0280], Fig. 43). However, Shelton fails to disclose wherein the distal cap portion of the structural body extends distally beyond the jaw liner and encloses at least a portion of the distal face of the jaw liner.
Sarley teaches an end effector assembly (see Figs. 178-180) comprising a distal cap portion (see electrode 2674 and electrode side walls 2676, Figs. 178-180) and a jaw liner (see clamp arm pad 2677, Figs. 178-180), wherein the distal cap portion extends distally beyond the jaw liner and encloses at least a portion of the distal face of the jaw liner (as shown in Fig. 178). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal cap portion of Shelton such that it extends distally beyond the jaw liner and encloses at least a portion of the distal face of the jaw liner in light of Sarley, the motivation being to provide the additional advantage of reducing gaps between the electrode and the lateral sides of the clamp jaw where tissue can build up during RF sealing (see Sarley [0682]).
Regarding claim 2, Shelton further discloses wherein the entire distal cap portion defines the electrode (see entire distal tip of 1022 defining the electrode, Fig. 42).
Regarding claim 3, Shelton in view of Sarley teaches the limitations of claim 1, however Shelton fails to further disclose wherein a portion of the distal cap portion is electrically insulative and wherein a distal cap electrode disposed on or within the electrically insulative portion defines the electrode within the same embodiment.
Shelton further discloses a portion of a distal cap portion being electrically insulative and wherein a distal cap electrode disposed on or within the electrically insulative portion defines the electrode (see electrodes 6208a-b and 6210a-b disposed on the insulative portion 6216, Figs. 71 and 72, [0397]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the distal cap portion in the embodiment of Figures 40-43 of Shelton such that a portion of the distal cap portion is electrically insulative and wherein a distal cap electrode disposed on or within the electrically insulative portion defines the electrode in light of the embodiment of Figures 71 and 72 of Shelton, the motivation being to provide the additional advantage of allowing the instrument to sense where tissue is present to more efficiently treat tissue being grasped (see Shelton [0396]).
Regarding claim 4, Shelton further discloses wherein a distal-most extent of the electrode and a distal-most extent of the distal face of the ultrasonic blade are substantially aligned with one another in the approximated position (see [0280], Fig. 40 and 43).
Regarding claim 6, Shelton further discloses wherein the jaw liner is formed from an electrically-insulative material (see [0280]).
Regarding claim 7, Shelton further discloses wherein the jaw liner is formed from a more-compliant material and the structural body is formed from a more-rigid material (see [0279]-[0281]).
Regarding claim 8, Shelton further discloses wherein the body portion of the structural body includes first and second electrode surfaces extending along opposing sides of the jaw liner, the first and second electrode surfaces adapted to connect to the source of electrosurgical energy at a potential different from the potential of the ultrasonic blade to enable conduction of bipolar energy between the first and second electrode surfaces and the ultrasonic blade and through tissue clamped therebetween in the approximated position (see surfaces 1046 on opposing sides extending along opposing sides of pad 1024 and adapted to connect to the source of energy at a different potential than the ultrasonic blade to enable conduction of bipolar energy as claimed, [0282], Fig. 43).
Regarding claim 9, Shelton in view of Sarley teaches the limitations of claim 8, however Shelton fails to further disclose wherein the electrode and the first and second electrode surfaces are independently energizable within the same embodiment.
Shelton further discloses an embodiment having multiple electrodes, wherein each of the plurality of electrode surfaces are independently energizable (see electrode surfaces L1-L5 and R1-R5, Figs. 79-81, [0408]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the electrode and electrode surfaces in the embodiment of Figures 40-43 of Shelton such that wherein the electrode and the first and second electrode surfaces are independently energizable in light of the embodiment of Figures 79-81 of Shelton, the motivation being to provide the additional advantage of allowing the instrument to only provide energy to locations where tissue is present to more efficiently treat tissue being grasped (see Shelton [0408]).
Regarding claim 10, Shelton further discloses wherein the electrode and the first and second electrode surfaces are electrically coupled to one another (see electrode surfaces being electrically coupled together, [0282]).
Regarding claim 11, Shelton further discloses wherein, in the approximated position, the ultrasonic blade and the first and second electrode surfaces define a second gap distance therebetween (see Fig. 43).
Regarding claim 12, Shelton further discloses wherein the gap distance and the second gap distance are different from one another (see annotated Figure 43 below).
PNG
media_image1.png
379
301
media_image1.png
Greyscale
(Annotated Shelton Fig. 43)
Response to Arguments
Applicant’s arguments with respect to claims 1 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In the instant case, the new grounds of rejection are based on the combination of the Shelton and Sarley references as newly set forth above which has not been specifically addressed by the arguments.
In response to applicant’s arguments directed to Shelton failing to disclose the alignment required by claim 4 (see Remarks pg. 8), the examiner respectfully disagrees. Applicant argues that the distal-most extent of electrode member 1022 cannot be aligned with the distal-most extent of distal face of 1006 since they do not overlap, however it appears in Fig. 40 that the two elements do overlap since 1022 covers 1006 as can be appreciated by comparing Figs. 40 and 41. Regardless, the claim does not specifically require that the distal-most extend of the electrode and the distal-most extent of the distal face overlap, it requires that they are substantially aligned with one another which can be mutually exclusive features. In the instant case, the examiner maintains that the distal-most extent of electrode member 1022 and the distal-most extent of distal face of 1006 are substantially aligned with one another in a parallel fashion in Fig. 40.
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 SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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, Joanne Rodden can be reached at 303-297-4276. 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.
/SEAN W COLLINS/Primary Examiner, Art Unit 3794