DETAILED ACTION
This action is in response to applicant's amendments filed 12/23/25.
The examiner acknowledges the amendments to the claims.
Claims 21-40 are pending in this application.
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 Arguments
In light of Applicant’s amendments to claims 21 and 37, the prior art rejections of claims 21-29, 37-39 have been withdrawn.
Applicant’s arguments with respect to claim(s) 30-36 have been considered but are moot in view of the new grounds of rejection, including Wilson in view of Ahlberg and Green, as set forth below.
Applicant’s arguments with respect to the double patenting rejections have been considered but are moot in view of the new grounds of rejection set forth below.
It is noted that the clip track recited in claim 30 does not require “inward-facing surfaces” of outer housings that receive and guide a clip, as is recited in claims 21 and 37. Claim 30 merely recites a clip track defined by polymer portions that receive a clip. In other words, claims 21 and 37 require that the “inner-facing surfaces” of the outer housings themselves directly receive and guide the clip, while claim 30 only requires that a clip track is defined by the overmolded polymer portion. The recited clip track in claim 30 may include additional surfaces inside of the polymer portions such as jaw surfaces 110/92, wherein the polymer portions indirectly receive and guide the clip via the jaw surfaces. As discussed below, Wilson discloses outer housings 130, 132 that encompass jaws 110/92 and clip 78 (Figures 2b-2c, 12), and therefore the outer housings receive and guide the clip indirectly by means of the jaws.
Claim Objections
Claim 28 is objected to because of the following informalities: in lines 6-7 it reads “a trigger operable to the trigger overcome the distal biasing force”, and should rather read as --a trigger operable to overcome the distal biasing force--. 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.
Claims 21-29 and 36 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 21, lines 14-15 recite “a second track formed in the outer housings of the jaws”. However, claim 21 previously recites in lines 10-11 “the outer housing of each jaw comprising an inward-facing surface defining a clip track”. It is unclear if “a second track” is actually referring to the previously recited “clip track” or is a separate track. For examination purposes, lines 10-11 will be read as --the outer housing of each jaw comprising an inward-facing surface defining a second track--, and lines 14-15 will be read as –the second track formed in the outer housings of the jaws--.
Claims 22-29 are rejected due to their dependency on Claim 21.
Claim 36, recites “a trigger…causes the distal-most surgical clip…to enter a second track”. However, claim 30, upon which claim 36 depends, recites a “a distal-most surgical clip…within the clip track” (lines 12-13). It is unclear if “a second track” is actually referring to the previously recited “clip track” or is a separate track. For examination purposes, the limitation “a second track” in claim 36 will be read as --the clip track--.
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.
Claims 30, 32-36 are rejected under 35 U.S.C. 103 as being unpatentable over Wilson, Jr. et al., hereinafter “Wilson” (U.S. Pat. No. 6,824,547) in view of Ahlberg et al., hereinafter “Ahlberg” (U.S. Pub. No. 2005/0101991).
Regarding claim 30, Wilson discloses a surgical system, comprising:
a surgical device comprising:
a handle 140 (Figures 1, 4-5),
an elongate shaft 20 extending distally from the handle, the elongate shaft defining a passage for a plurality of surgical clips (such as clips 78; Figures 12-13, col. 7, lines 35-36, col. 8, line 45), each of the plurality of surgical clips including a pair of legs (Id.), and
a pair of jaws (see upper and bottom portions of 110/92; Figures 2b-2c) coupled to the elongate shaft, the pair of jaws being movable between an open position and a closed position (Figures 12-13), each jaw of the pair of jaws including a metal portion (98/116 and 102/122 made of suitable metal; col. 8, lines 30-32) and a portion 130/132 on the metal portion and defining a clip track (see Figures 2c and 12; portions 130/132 form channels that surround clip 78 and jaws 110/92, and define a clip track that receive and guide clip 78 via surfaces of the jaws);
wherein the plurality of surgical clips is adapted for distal advancement along the elongate shaft, with the pair of legs of a distal-most surgical clip of the plurality of surgical clips within the clip track (78 is positioned within clip track via jaws 110/92 within portions 130/132); and
wherein, when the pair of jaws is in the closed position, the pair of legs of the distal-most surgical clip are bent (Figures 12-13).
However, Wilson does not disclose that the portions are polymer portions, and the polymer portions being overmolded onto the metal portions.
Ahlberg teaches a method of manufacturing a jaw assembly including forming a metal frame defining first and second jaws ([0005]), and overmolding first and second housings around the first and second jaws, respectively (overmolding atraumatic plastic material over the metallic jaws; see abstract, [0008], [0049]).
It would have been obvious to one of ordinary skill before the effective filing date to modify the portions of Wilson such that they are overmolded portions as claimed, as taught by Ahlberg, to form a rigid composite jaw assembly with an atraumatic outer surface using relatively inexpensive manufacturing technologies (Id.).
Regarding claim 32, Wilson as modified teaches wherein the pair of jaws includes a first jaw (98/116; Wilson) having a first surface; a first protrusion (hook 98a/116a) extends from the first surface of the first jaw and into the polymer portion 130 of the first jaw (see Figure 12 where the hooks extend beyond the housing); the pair of jaws includes a second jaw 102/122 having a second surface facing the first surface of the first jaw; and a second protrusion (hook 102a/122a) extends from the second surface of the second jaw and into the polymer portion 132 of the second jaw (Id.).
Regarding claim 33, Wilson as modified teaches the pair of legs of the distal-most surgical clip of the plurality of surgical clips includes a first leg and a second leg (see legs of clip 78 in Figures 12-13 of Wilson);
wherein the first protrusion (hook 98a/116a) extends to contact the first leg within the polymer portion of the first jaw (Figure 12; see 98a/116a contacting boss 79a of clip); and
wherein the second protrusion (hook 102a/122a) extends to contact the second leg within the polymer portion of the second jaw (Id.; see 102a/122a contacting boss 79b of clip).
Regarding claim 34, Wilson as modified teaches further comprising the plurality of surgical clips (Figure 2b, col. 7, lines 35-36 of Wilson).
Regarding claim 35, Wilson as modified teaches the pair of jaws includes a first jaw 98/116 and a second jaw 102/122 (Wilson); wherein the polymer portion 130 (as modified by Ahlberg) of the first jaw overlies the metal portion of the first jaw; and the polymer portion 132 (as modified by Ahlberg) of the second jaw overlies the metal portion of the second jaw.
Regarding claim 36, Wilson as modified teaches a surgical method, comprising:
actuating a trigger 144 (Figure 1; Wilson) of the surgical device causes the distal-most surgical clip of the plurality of surgical clips 78 to enter a second track, or the clip track (Figures 6-8, col. 9, lines 44-51; “the most distal clip 78 is fed into the jaw assembly 90”).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Wilson (U.S. Pat. No. 6,824,547) in view of Ahlberg (U.S. Pub. No. 2005/0101991), as applied to claim 30 above, and further in view of Green et al., hereinafter “Green” (U.S. Pat. No. 5,100,420).
Regarding claim 31, Wilson as modified teaches the claimed invention, as discussed above, except for each polymer portion including a surface facing an opposing polymer portion, the facing surfaces being non-planar and non-linear.
In Figures 19a-19b, Green teaches a clip track including portions having opposing facing surfaces that are non-planar and non-linear (curved grooves 135c face each other).
It would have been obvious to one of ordinary skill before the effective filing date to modify the polymer portions to have opposing facing portions that are non-planar and non-linear, as taught by Green, in order to help conform to the clip in the track and facilitate proper alignment and positioning of the clip (Green; col. 9, lines 46-47).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-27, 29-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 11, 20 of U.S. Patent No. 11,937,820 in view of Wilson (U.S. Pat. No. 6,824,547). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims encompass the application claims (see corresponding claims in the chart below), and include limitations such as overmolded first and second housings over the jaws/arms (patent claims 4 and 15), except for features that are merely obvious. For instance, Wilson teaches the claimed features above, including a handle 140 (Figures 1, 4-5), an elongate shaft 20 extending distally from the handle and having a first track 72 (Figures 8-10) formed therein, the first track being configured to slidably seat a plurality of surgical clips therein (such as clips 78; Figures 12-13, col. 7, lines 35-36), each of the plurality of surgical clips including a pair of legs (Id.). Wilson further teaches a surgical method (col. 5, lines 20-40), comprising: actuating a trigger of the surgical device of the surgical system of claim 21 (as discussed above, and discussed regarding claim 28), the actuation of the trigger causing the distal-most one of the plurality of clips to enter the second track (Id.). It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Wilson, in order to facilitate user actuation of feeding multiple clips from a supply.
Claim 28 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 11, 20 of U.S. Patent No. 11,937,820 in view of Wilson (U.S. Pat. No. 6,824,547), as applied to claim 21 above and further in view of Green (U.S. Pat. No. 5,100,420). Regarding claim 28, the patent claims and Wilson teach the claimed invention, as discussed above, except for wherein the surgical device further comprises: a spring configured to, with the plurality of surgical clips slidably received in the first track (such as clips 138/139 in Wilson; Figure 18, col. 9, lines 18-21), apply a distal biasing force on the plurality of surgical clips (although Wilson teaches in col. 14, lines 17-20 biasing a clip channel [first track 7]) in a distal direction, and a trigger configured to be actuated, the actuation of the trigger being configured to overcome the distal biasing force to allow the distal-most one of the plurality of clips to enter the second track (although Wilson teaches a trigger 144 configured to be actuated to allow a distal-most clip to enter the second track, or within the second track within the jaw assembly 90; col. 9, line 44 to col. 10, line 24).
Green teaches in col. 4, lines 17-33 a spring (spring means) configured to, with a plurality of surgical clips slidably received in a first track, apply a distal biasing force the plurality of surgical clips, and a trigger (actuating means such as a pivoting handle) configured to be actuated, the actuation of the trigger being configured to overcome the distal biasing force to allow the distal-most one of the plurality of clips to enter a second track in jaws (actuating means transfers movement to clip advancing means; also see pusher bar 43 for advancing clips 138 one at a time to a second track 135c in Figures 19a-19b).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Wilson with a spring, apply a distal biasing force on the plurality of surgical clips in a distal direction, and a trigger configured to be actuated, the actuation of the trigger being configured to overcome the distal biasing force to allow the distal-most one of the plurality of clips to enter the second track, as taught by Green, since doing so would be substitution of one known clip advancement mechanism for another, which would yield predictable results, namely advancing the clips into the jaws for deployment. See MPEP 2143.
Application No. 18/611,511 claims
U.S. Pat. No. 11,937,820 claims
U.S. Pat. No. 10,959,732 claims
21
1, 11
1, 11, 20
22
9, 20
6, 16
23
8, 9, 20
6, 16
24
1, 11
1, 11, 20
25
7
4
26
7
4
27
1, 11
1, 11, 20
28
1, 11
1, 11, 20
29
1, 11
1, 11, 20
30
8
5
31
8
5
32
8
5
33
8
5
34
8
5
35
8
5
36
8
5
37
1, 11
5
38
1, 11
5
39
1, 11
5
40
Claims 21-23, 25-27, 29-30, 32-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 11, 16, 20 of U.S. Patent No. 10,959,732 in view of Wilson (U.S. Pat. No. 6,824,547). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims encompass the application claims (see corresponding claims in the chart above), and include limitations such as overmolded first and second housings over the jaws/arms (patent claims 2, 12 and 22), except for features that are merely obvious. For instance, Wilson teaches the claimed features above, including a handle 140 (Figures 1, 4-5), an elongate shaft 20 extending distally from the handle and having a first track 72 (Figures 8-10) formed therein, the first track being configured to slidably seat a plurality of surgical clips therein (such as clips 78; Figures 12-13, col. 7, lines 35-36), each of the plurality of surgical clips including a pair of legs (Id.). Wilson further teaches a surgical method (col. 5, lines 20-40), comprising: actuating a trigger of the surgical device of the surgical system of claim 21 (as discussed above, and discussed regarding claim 28), the actuation of the trigger causing the distal-most one of the plurality of clips to enter the second track (Id.). It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims with the above features, as taught by Wilson, in order to facilitate user actuation of feeding multiple clips from a supply.
Claim 24, 28, 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 11, 16, 20 of U.S. Patent No. 10,959,732 in view of Wilson (U.S. Pat. No. 6,824,547), as applied to claim 21 above and further in view of Green (U.S. Pat. No. 5,100,420). Regarding claims 24, 28, 31, the patent claims and Wilson teach the claimed invention, as discussed above, except for the outer housings of the pair of jaws include housings having facing non-planar and non-linear surfaces, and wherein the surgical device further comprises: a spring configured to, with the plurality of surgical clips slidably received in the first track (such as clips 138/139 in Wilson; Figure 18, col. 9, lines 18-21), apply a distal biasing force on the plurality of surgical clips (although Wilson teaches in col. 14, lines 17-20 biasing a clip channel [first track 7]) in a distal direction, and a trigger configured to be actuated, the actuation of the trigger being configured to overcome the distal biasing force to allow the distal-most one of the plurality of clips to enter the second track (although Wilson teaches a trigger 144 configured to be actuated to allow a distal-most clip to enter the second track, or within the second track within the jaw assembly 90; col. 9, line 44 to col. 10, line 24).
Green teaches portions include facing non-planar and non-linear surfaces (Figures 19a-19b; curved grooves 135c face each other) and in col. 4, lines 17-33 a spring (spring means) configured to, with a plurality of surgical clips slidably received in a first track, apply a distal biasing force the plurality of surgical clips, and a trigger (actuating means such as a pivoting handle) configured to be actuated, the actuation of the trigger being configured to overcome the distal biasing force to allow the distal-most one of the plurality of clips to enter a second track in jaws (actuating means transfers movement to clip advancing means; also see pusher bar 43 for advancing clips 138 one at a time to a second track 135c in Figures 19a-19b).
It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Wilson with a spring, apply a distal biasing force on the plurality of surgical clips in a distal direction, and a trigger configured to be actuated, the actuation of the trigger being configured to overcome the distal biasing force to allow the distal-most one of the plurality of clips to enter the second track, as taught by Green, since doing so would be substitution of one known clip advancement mechanism for another, which would yield predictable results, namely advancing the clips into the jaws for deployment. See MPEP 2143. It would have been obvious to one of ordinary skill before the effective filing date to modify the patent claims and Wilson with facing non-planar and non-linear surfaces, as taught by Green, in order to conform to the non-planar and non-linear shaped clips for controlled guidance.
Allowable Subject Matter
Claims 21-29 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, and if a Terminal Disclaimer is filed to overcome the double patent rejections set forth in this Office action.
Claims 37-39 would be allowable if a Terminal Disclaimer is filed to overcome the double patent rejections set forth in this Office action.
Claim 40 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter (also reasons for indication of allowable subject matter on page 25 of office action filed 09/24/25):
None of the prior art of record, alone or in combination, teaches or renders obvious a surgical clip applier including, inter alia, a pair of jaws each being overmolded with outer housings that each comprise an inward-facing surface defining a clip track for receiving and guiding a pair of legs of a surgical clip, or a method including, inter alia, overmolding first and second housings around first and second jaws to form opposed inward facing surfaces, each having a clip track formed therein and extending therealong for receiving and guiding a clip into the jaws.
Conclusion
THIS ACTION IS MADE FINAL. 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 DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771