DETAILED ACTION
This action is pursuant to RCE filed on 12/2/2025. Claims 1 and 4-16 are pending, claims 2 and 3 have been cancelled by the applicant. A non-final action on the merits of claims 1 and 4-16 is as follows.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/2/2025 has been entered.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-6 and 10-11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Frushour et al. (hereinafter ‘Frushour’, US 20180042632 A1).
Regarding independent claim 1, Frushour discloses a surgical instrument (surgical instrument in Fig. 1), comprising:
a pair of jaws having a first jaw member and a second jaw member (pair of jaws comprising first jaw member 110 and second jaw member 120 in Fig. 4) that are pivotally mounted with respect to each other for movement between an open position and a closed position ([0054]: the jaws are mounted to move between a spaced-apart, open configuration and an approximated, closed position for grasping tissue);
a first sealing surface (tissue contacting surface 114 in Fig. 5A) supported by the first jaw member (supported on jaw member 110 as seen in Fig. 5A) and having a first track formed (track 117 in Fig. 5A) therein that extends from a first open end (open end is the proximal side of the track where the back is open nearest the handle in Fig. 5A) to a first closed end (this is the distal side of the track furthest from the handle in Fig. 5A; the claim does not explicitly state which part of the track is closed and is thus interpreted as the most distal edge and the bottom as both are closed near the distal end; additionally, “end” is a broad term that is interpreted to be the distal half of the track as the claim does not limit “end” to the very tip of the track);
a second sealing surface (sealing surface 124 in Fig. 5B) supported by the second jaw member (supported on jaw member 120 in Fig. 5B) and having a second track formed therein (second track 127 in Fig. 5B) that extends from a second open end (open end is the proximal side of the track where the back is open nearest the handle in Fig. 5B) to a second closed end (this is the distal side of the track furthest from the handle in Fig. 5B; the claim does not explicitly state which part of the track is closed and is thus interpreted as the most distal edge and the bottom as both are closed near the distal end; additionally, “end” is a broad term that is interpreted to be the distal half of the track as the claim does not limit “end” to the very tip of the track) and that will align with the first track when the pair of jaws are in the closed position to define a knife pathway ([0060]: the plates 114 and 124 define a knife channel 117, 127 that extends therethrough and receives a knife to facilitate reciprocation of the knife between the jaw member to cut tissue);
a first slot (slot 118 in Fig. 5A) formed in a first distal end of the first jaw member (the last slot is on the distal end of the jaw member as highlighted below; as broadly claimed, the first distal end of the first jaw member is the entire distal half of the jaw as the word “end” can be interpreted as a general area rather than the very tip of the jaw member) that penetrates through the first closed end of the first track (the slot 118 penetrates through the closed, distal end of the track as seen in Fig. 5A; again “the first closed end” is broadly interpreted as the distal half of the slot that is closed on the top and most distal edge because the claim does not state which part of the track is closed) so that the first slot is in communication with the first track ([0061]: the holes 118 extend through the jaw to be in communication with the knife channel); and
a second slot (slot 128 in Fig. 5B) formed in a second distal end of the second jaw member (the last slot is on the distal end of the jaw member as highlighted below; as broadly claimed, the second distal end of the second jaw member is the entire distal half of the jaw as the word “end” can be interpreted as a general area rather than the very tip of the jaw member) that penetrates through the second closed end of the second track (the slot 128 penetrates through the closed, distal end of the track as seen in Fig. 5B; again “the second closed end” is broadly interpreted as the distal half of the slot that is closed on the bottom and most distal edge because the claim does not state which part of the track is closed) so that the second slot is in communication with the second track ([0061]: the holes 128 extend through the jaw to be in communication with the knife channel).
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Regarding claim 4, Frushour discloses the surgical instrument of claim 1, further comprising a knife blade (knife blade 84 as seen in Figs. 9 and 11) positioned in the knife pathway and moveable in the knife pathway toward the first closed end of the first track and the second closed end of the second track ([0060]: the knife is positioned in the knife channel 117, 127 and reciprocates along it to cut tissue disposed between the jaws – in order to cut tissue the knife must inherently move toward the close, distal ends of the tracks).
Regarding claim 5, Frushour discloses the surgical instrument of claim 4, wherein movement of knife blade in the knife pathway will cause any debris in the knife pathway to be ejected from at least one of the first slot and the second slot ([0061]: the vent holes are arranged in communication with the knife channel to allow steam to escape; this is a functional limitation of the device and as such the prior art must be capable of the claimed functional limitation; in the present case, just as steam can escape through the vent holes, so can debris as the knife is actuated toward the vent holes).
Regarding claim 6, Frushour discloses the surgical instrument of claim 5, wherein the first slot and the second slot extend under the first sealing surface and the second sealing surface, respectively (the slots 118 and 128 extend under the respective sealing surfaces as seen in Figs. 5A and 5B).
Regarding independent claim 10, Frushour discloses a method of clearing debris from a surgical instrument, comprising:
providing a vessel sealer including pair of jaws formed by a first jaw member (pair of jaws comprising first jaw member 110 in Fig. 4 is provided) having a first sealing surface (tissue contacting surface 114 in Fig. 5A) with a first track (track 117 in Fig. 5A) having a first closed end (the distal side of the track furthest from the handle in Fig. 5A; the claim does not explicitly state which part of the track is closed and is thus interpreted as the most distal edge and the bottom as both are closed near the distal end; additionally, “end” is a broad term that is interpreted to be the distal half of the track as the claim does not limit “end” to the very tip of the track) and a first slot (slot 118 in Fig. 5A) formed in a first distal end of the first jaw member (the last slot is on the distal end of the jaw member as highlighted below; as broadly claimed, the first distal end of the first jaw member is the entire distal half of the jaw as the word “end” can be interpreted as a general area rather than the very tip of the jaw member) that penetrates through the closed end of the first track (the slot 118 penetrates through the closed, distal end of the track as seen in Fig. 5A; again “the first closed end” is broadly interpreted as the distal half of the slot that is closed on the top and most distal edge because the claim does not state which part of the track is closed) to be in communication with the first track ([0061]: the holes 118 extend through the jaw to be in communication with the knife channel) and a second jaw member (second jaw member 120 in Fig. 4) having a second sealing surface (sealing surface 124 in Fig. 5B) with a second track (second track 127 in Fig. 5B) having a second closed end (the distal side of the track furthest from the handle in Fig. 5B; the claim does not explicitly state which part of the track is closed and is thus interpreted as the most distal edge and the bottom as both are closed near the distal end; additionally, “end” is a broad term that is interpreted to be the distal half of the track as the claim does not limit “end” to the very tip of the track) and a second slot (slot 128 in Fig. 5B) formed in a second distal end of the second jaw member (the last slot is on the distal end of the jaw member as highlighted below; as broadly claimed, the second distal end of the second jaw member is the entire distal half of the jaw as the word “end” can be interpreted as a general area rather than the very tip of the jaw member) that penetrates through the closed end of the first track (the slot 128 penetrates through the closed, distal end of the track as seen in Fig. 5B; again “the second closed end” is broadly interpreted as the distal half of the slot that is closed on the bottom and most distal edge because the claim does not state which part of the track is closed) to be in communication with the second track ([0061]: the holes 128 extend through the jaw to be in communication with the knife channel); and
extending a knife blade within the first track and the second track ([0060]: the knife is positioned in the knife channel 117, 127 and reciprocates along it to cut tissue disposed between the jaws) to push any debris out of the first slot and the second slot ([0061]: the vent holes are arranged in communication with the knife channel to allow steam to escape; this is a functional limitation of the device and as such the prior art must be capable of the claimed functional limitation; in the present case, just as steam can escape through the vent holes, so can debris as the knife is actuated toward the vent holes; thus the claimed method would necessarily be met through the routine use of the device).
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Regarding claim 11, Frushour discloses the method of claim 10, wherein the first slot and the second slot extend under the first sealing surface and the second sealing surface, respectively (the slots 118 and 128 extend under the respective sealing surfaces as seen in Figs. 5A and 5B).
Regarding claim 15, Frushour discloses the surgical instrument of claim 1, wherein the first slot is in communication with the first closed end of the first track and the second slot is in communication with the second closed end of the second track when the pair of jaws are in the open position and when the jaws are in a closed position and a knife is fully extended into the knife pathway ([0061]: the holes 118 and 128 extend through the jaws to be in communication with the knife channels – this is true regardless of whether the jaws are open or if they are closed and the knife is extended; the holes extend into the closed ends of the knife channels and remain in place regardless of the actuation state of the jaws or knife).
Regarding claim 16, Frushour discloses the method of claim 10, wherein the first slot is in communication with the first closed end of the first track and the second slot is in communication with the second closed end of the second track during the step of extending a knife blade within the first track and the second track to push any debris out of the first slot and the second slot ([0061]: the holes 118 and 128 extend through the jaws to be in communication with the knife channels – this is true regardless of whether the jaws are open or if they are closed and the knife is extended; the holes extend into the closed ends of the knife channels and remain in place regardless of the actuation state of the jaws or knife).
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.
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.
Claim(s) 7-9 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Frushour as applied to claims 6/5/4/1 and 11/10 respectively and described above.
Regarding claim 7, Frushour discloses the surgical instrument of claim 6/5/4/1 as described above. Frushour further discloses that the vent holes have a width as seen in Figs. 5A and B.
However, Furshour is silent to the slots having a first width proximate the tip of the jaws and a second width proximate the respective tracks that is wider than the first width.
The vent holes of Froushour have an opening at the top, which is proximate to the tip of the jaws as it is very near or close to the tip of the jaws. The width at the bottom of the holes is proximate the respective tracks. As written, given the broadest reasonable interpretation of the claim, there is no limitation that both widths cannot be proximate to the tip of the pair of jaws since the orientation of the slot is not defined. Frushour does not limit the shape of the holes, just that they are capable of venting steam buildup ([0061]). Furthermore, the instant application does not state the benefit of creating different widths within the slot. The instant application discusses the dimensions of the widths of the slots but does not assign criticality or benefit to those dimensions (page 6 of the instant application). It would have been an obvious matter of design choice to adjust the shape of the slot such that the width closest to the track is wider than the exit, since the applicant has not disclosed that varying the widths solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with one consistent width. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 8, Frushour discloses the surgical instrument of claim 7, wherein the first slot and the second slot each have a depth that extends at least halfway through the first jaw member and the second jaw member, respectively ([0061]: the vent holes 118 and 128 extend completely through the distal jaw bodies; the claim does not state on which part of the jaw the slots extend at least halfway through and in the distal locations in which they are disposed, they extend all of the way through into the knife channel).
Regarding claim 9, Frushour discloses the surgical instrument of claim 8, wherein the first track and the second track are curved ([0060]: the jaw bodies and tissue contacting surfaces define curved configurations, thus if the curved jaws define a curved knife channel; this can be seen in Fig. 7 where the vent holes 118 follow the curved knife channel).
Regarding claim 12, Frushour discloses the surgical instrument of claim 6/5/4/1 as described above. Frushour further discloses that the vent holes have a width as seen in Figs. 5A and B.
However, Furshour is silent to the slots having a first width proximate the tip of the jaws and a second width proximate the respective tracks that is wider than the first width.
The vent holes of Froushour have an opening at the top, which is proximate to the tip of the jaws as it is very near or close to the tip of the jaws. The width at the bottom of the holes is proximate the respective tracks. As written, given the broadest reasonable interpretation of the claim, there is no limitation that both widths cannot be proximate to the tip of the pair of jaws since the orientation of the slot is not defined. Frushour does not limit the shape of the holes, just that they are capable of venting steam buildup ([0061]). Furthermore, the instant application does not state the benefit of creating different widths within the slot. The instant application discusses the dimensions of the widths of the slots but does not assign criticality or benefit to those dimensions (page 6 of the instant application). It would have been an obvious matter of design choice to adjust the shape of the slot such that the width closest to the track is wider than the exit, since the applicant has not disclosed that varying the widths solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with one consistent width. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 13, Frushour discloses the method of claim 12, wherein the first slot and the second slot each have a depth that extends at least halfway through the first jaw member and the second jaw member, respectively ([0061]: the vent holes 118 and 128 extend completely through the distal jaw bodies; the claim does not state on which part of the jaw the slots extend at least halfway through and in the distal locations in which they are disposed, they extend all of the way through into the knife channel).
Regarding claim 14, Frushour discloses the method of claim 13, wherein the first track and the second track are curved ([0060]: the jaw bodies and tissue contacting surfaces define curved configurations, thus if the curved jaws define a curved knife channel; this can be seen in Fig. 7 where the vent holes 118 follow the curved knife channel).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 4-16 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.
The examiner recommends amending the claims to more precisely describe the orientation of the slot penetrating through the end of the track. “A first distal end” can be reasonably interpreted as the entire half of the jaw that is positioned distally on the jaw member. Similarly, “a closed end” can be any area of the track that is closed near the end of the track. The claim does not explicitly state that the slot extends through the face of the jaw that is located on the tip of the jaws and perpendicular to the respective sealing surfaces. The slot located on the top as shown in Frushour is still penetrating through a closed end of the track and is located on the distal end of the jaws. The face through which the slot penetrates and the orientation of the slot in relation to the knife track must be specifically defined.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571)272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794