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
As of the reply filed 3/02/2026, claims 1-20 are pending. Claims 1, 8-9, and 16 have been amended.
Response to Arguments
Applicant's arguments, filed 3/02/2026, have been considered but they are moot because the new grounds of rejection each rely upon a different combination of previously cited references in order to read on the amended limitations as challenged in Applicant’s arguments.
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 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, 6, and 8-15 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US PGPub 2019/0314031 A1) in view of Wilson et al. (US PGPub 2005/0165422 A1) and Barker et al. (US PGPub 2002/0200179 A1).
With respect to claim 1, Thomas et al. discloses a surgical clip (10 in Fig. 1) comprising:
a first leg member (12) having a first inner surface (62) with a first curvature (inner surface 62 is curved, see Fig. 4, PP [0036]: “the first and second jaws 12, 14 are curved along the longitudinal axis “Z””) and a pair of first outer side surfaces (outer side surfaces of longitudinal rib 60, see annotation below) on opposite sides of the first leg member (12), the first inner surface (62) extending laterally between the first outer side surfaces (outer side surfaces of longitudinal rib 60), the first leg member (12) having a first thickness in a vertical direction, a first width in a lateral direction, and a first length in a longitudinal direction (see Figs. 1-2, 12 has these dimensions), wherein the first width is defined by at least one first lateral protrusion (overhang portion of 12a, see annotated Fig. 4 below) extending from at least one of the first outer side surfaces (outer side surfaces of longitudinal rib 60) of the first leg member (12); and
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a second leg member (14) having a second inner surface (71 in Fig. 4) with a second curvature (concave inner surface 71 is curved, PP [0036]: “the first and second jaws 12, 14 are curved along the longitudinal axis “Z””) and a pair of second outer side surfaces (see outer side surfaces of 14a in Fig. 2) on opposite sides of the second leg member (14), the second inner surface (71) extending laterally between the second outer side surfaces (outer side surfaces of 14a), the second leg member (14) having at least one first tooth (70a in Fig. 4A) on a first portion of the second leg member (70a is arranged in a row on one side of second leg member 14), at least one second tooth (70b) on a second portion of the second leg member (70b is arranged in a row on an opposite side of second leg member 14), and a second width in the lateral direction (width of 14 in Fig. 4);
wherein the second width of the second leg member (14) is greater than an outer width of the first leg member (12), the outer width defined by the first outer side surfaces (outer side surfaces of longitudinal rib 60, see annotated Fig. 4 above) of the first leg member (12, the second width of 14 between body 14a encompasses the width of longitudinal rib 60 of the first leg member 12, see closed view in Fig. 3);
wherein the at least one tooth (70a-b) of the second leg member (14) extends past the first inner surface (62) of the first leg member (12) when the surgical clip (10) is in a closed configuration (see Fig. 3); and
wherein each first outer surface (outer side surfaces of longitudinal rib 60, see annotated Fig. 4 above) of the first leg member (12) is disposed between the at least one first tooth (70a) on the first portion of the second leg member (14) and the at least one second tooth (70b) on the second portion of the second leg member (14) when the surgical clip is in the closed position (see Fig. 3, teeth 70a-b extend past longitudinal rib 60 such that the outer side surfaces of longitudinal rib 60 are disposed between the teeth).
However, Thomas et al. fails to disclose wherein the second width is defined by at least one second lateral protrusion extending from at least one of the second outer side surfaces of the second leg member, or wherein the first width is greater than the first thickness along at least half of the first length or wherein the at least one tooth of the second leg member extends past the first inner surface of the first leg member when the surgical clip is in a closed configuration.
In the same field of surgical clips, Wilson et al. teaches a surgical clip (1 in Fig. 1) comprising a first leg member (22) and a second leg member (24), wherein the second leg member (24) comprises outer side surfaces (52) and further comprises a second width defined by at least one second lateral protrusion (80) extending from at least one of the second outer side surfaces (52) of the second leg member (24).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Thomas et al. device to include at least one lateral protrusion on the second leg member as taught by the Wilson et al. reference. One of ordinary skill in the art would have been motivated to perform this modification in order to “aid the physician in cutting the ligated vessel or tissue properly, such that a tissue cuff of safe length (typically about 1.0-3.0 mm) is produced” (PP [0038]). Doing so would not have altered the main operating principle of the Thomas et al. device, which is also used for ligating blood vessels (see PP [0003] of Thomas et al.), and furthermore applying the lateral protrusions of Wilson et al. to only the second leg member would have been obvious to one of ordinary skill in the art because Wilson et al. specifically contemplates the placement of a lateral protrusion on only one leg in order to serve as a positioning marker to the physician indicating where to cut the clamped blood vessel (PP [0043]: “Clip 12 can have only one (or more) cutting guide(s) 80 on just one side surface 52 or 54 of only one or both of legs 22 or 24, if desirable, for a particular application. For example, a specialty clip 12 can be designed for a particular application where specific placement of clip 12 is imperative. In such a scenario, it could be preferable to have cutting guide 80 placed at a particular site, e.g. on only one side surface 52 or 54 of one or both first and second legs 22 and 24, as a marker for the physician to properly position clip 12, or as a reminder of where to cut after positioning”).
However, Thomas et al. as modified by Wilson et al. further fails to disclose wherein the first width is greater than the first thickness along at least half of the first length or wherein the at least one tooth of the second leg member extends past the first inner surface of the first leg member when the surgical clip is in a closed configuration.
In the same field of surgical clips (abstract), Barker et al. teaches a surgical clip comprising a first width (dimension ‘X’ in Fig. 6A), a first thickness (dimension ‘Z’ in Fig. 4B), and a first length (dimension ‘Y’ in Fig. 6A), wherein the first width (X) is greater than the first thickness (Z) along at least half of the first length (Y, PP [0080]: “in the second embodiment of clip where the width, length and height of the clip are referenced “X”, “Y”, and “Z” respectively, the height “Z” of the closed clip is fairly small and is smaller than the width “X” and length “Y” of the clip”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Thomas et al. and Wilson et al. combination to incorporate the teachings of Barker et al. and include wherein the first width is greater than the first thickness along at least half of the first length. One of ordinary skill in the art would have been motivated to perform this modification because Barker et al. teaches that providing a clip comprising a greater width helps to improve clip security and reduce the likelihood of the clip damaging the vessel wall (Barker et al. PP [0066]), which would not alter the main operating principle of the Thomas et al. device but would simply prevent damage while ensuring stability as taught by the Barker et al. reference.
Regarding claim 2, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the at least one first lateral protrusion (overhang portion of body 14a of first leg member 14 in Fig. 1 of Thomas et al., see annotated Fig. 4 above) extends at least two-thirds of the first length of the first leg (12, see Fig. 1, the overhang of body 14a extends the entire length of leg 12).
Regarding claim 3, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the second leg member (14 in Fig. 1 of Thomas et al.) has a second length in a longitudinal direction (see Fig. 1), and wherein the at least one second lateral protrusion (80 on 24 in Fig. 1 of Wilson et al., the combination as proposed would add this onto leg 14 in Fig. 1 of Thomas et al.) extends at least two-thirds of the second length of the second leg (14 in Fig. 1 of Thomas et al., see Wilson et al. PP [0038]: “Cutting guides 80 have a length L in the lengthwise direction of first and second legs 22 and 24 that varies according to need. One of skill in the art will appreciate different benefits to different lengths L, and the presently disclosed subject matter is intended to be inclusive of these variations based on design choice”, PP [0039]: “It is envisioned that length L can be as great as the length of opposing side surface 52 or 54”).
Regarding claim 4, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses at least one boss member (32 in Fig. 1 of Thomas et al.) on a distal portion of the first leg member (12).
Regarding claim 6, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses a hinge member (16 in Fig. 1 of Thomas et al.) pivotably joining the first leg member (12) and the second leg member (14).
Regarding claim 8, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the at least one tooth (70a-b in Figs. 4 and 4A of Thomas et al.) is positioned laterally of the second inner surface (71) of the second leg member (12, see Fig. 4, teeth 70a-b are laterally oriented along the length of channel 71).
Regarding claim 9, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the at least one tooth (70a-b in Figs. 4 and 4A of Thomas et al.) on the second leg member (14) comprises a plurality of teeth (70a-b), the plurality of teeth (70a-b) including a first row of teeth and a second row of teeth (see rows in Fig. 1).
Regarding claim 10, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the first row of teeth and the second row of teeth (70a-b in Figs. 4 and 4A of Thomas et al.) are configured to receive the first inner surface (62) of the first leg member (12) therebetween when the surgical clip is in the closed configuration (see Fig. 3).
Regarding claim 11, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the first row of teeth and the second row of teeth (70a-b in Figs. 4 and 4A of Thomas et al.) are staggered longitudinally (see Fig. 1, the rows 70a-b have gaps between them such that they are staggered longitudinally).
Regarding claim 12, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses a heel (16a in Fig. 1 of Wilson et al.) at a proximal portion of the second leg member (14), the heel (16a) configured to increase securement of tissue (PP [0036]: “The through bore 16a also allows for substantially complete closure of the proximal portions of the first and second jaws 12, 14”, this complete closure increases securement of tissue).
Regarding claim 13, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses a hook member (30 in Fig. 1 of Thomas et al.) on a distal portion of the first leg member (12), and a tip member (48) on a distal portion of the second leg member (14), wherein the hook member (30) is configured to engage the tip member (48) to retain the surgical clip in a closed configuration (PP [0039]: “The cam surface 48 and the engagement surface 46 are configured to receive and guide the first locking element 30 into locking engagement with the second locking element 40 when the ligation clip 10 is moved to the clamped position (FIG. 3) to secure the ligation clip 10 in the clamped position. In particular, the cam surface 48 is configured to deflect the first locking element 30 outwardly in a distal direction as the first locking element 30 passes over the cam surface 48 such that when the first locking element 30 moves past the cam surface 48, the first locking element 30 resiliently moves into engagement with the second locking element 40 (FIG. 2A)”).
Regarding claim 14, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the surgical clip is a one-piece polymeric body (Thomas et al. PP [0045]: “the surgical ligation clip 10 may be made, in whole or in part, of a resilient bioabsorbable and/or biocompatible polymeric material. Examples of suitable bioabsorbable and/or biocompatible polymers include acetal polyoxymethylene (POM), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polyoxymethylene, polyetheretherketone (PEEK), polypropylene, and polyethylene or other thermoplastic materials having similar properties that can be injection-molded”, Wilson et al. PP [0029]: “clip 12 preferably comprises a one-piece integral polymeric body formed from a suitable strong biocompatible engineering plastic such as the type commonly used for surgical implants”, the clip as proposed would have a one-piece polymeric body since both Thomas et al. and Wilson et al. support a one-piece polymeric body).
Regarding claim 15, Thomas et al. as modified by Wilson et al. and Barker et al. further discloses wherein the first inner surface (62 in Fig. 4 of Thomas et al. has a concave curvature (see Fig. 4) extending from a proximal portion to a distal portion of the first leg member (12), and the second inner surface (71 in Fig. 4) has a convex curvature (see Fig. 4) extending from a proximal portion to a distal portion of the second leg member (14).
Claims 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US PGPub 2019/0314031 A1) in view of Barker et al. (US PGPub 2002/0200179 A1).
With respect to claim 16, Thomas et al. discloses a surgical clip (10 in Fig. 1) comprising:
a first leg member (12) having a first inner surface (62) with a first curvature (inner surface 62 is curved, see Fig. 4, PP [0036]: “the first and second jaws 12, 14 are curved along the longitudinal axis “Z””) and a pair of first outer side surfaces (outer side surfaces of longitudinal rib 60, see annotated Fig. 4 below) on opposite sides of the first leg member (12), the first inner surface (62) extending laterally from one of the first outer side surfaces on a first portion of the first leg member (12) to the other one of the first outer side surfaces on a second portion of the first leg member (12, inner surface 62 extends laterally between the side walls of longitudinal rib 60, see annotated Fig. 4 below), the first leg member (12) having a first thickness in a vertical direction, a first width in a lateral direction defined by at least one first lateral protrusion (width of overhang portion of 12a, see annotated Fig. 4 below) extending from at least one of the first outer side surfaces (outer side surfaces of longitudinal rib 60) of the first leg member (12), a first length in a longitudinal direction (see Figs. 1-2, 12 has these dimensions),), and a first outer width in the lateral direction between the first outer side surfaces (width of 62 extending between outer side surfaces of longitudinal rib 60); and
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a second leg member (14) having a second inner surface (71 in Fig. 4) with a second curvature (concave inner surface 71 is curved, PP [0036]: “the first and second jaws 12, 14 are curved along the longitudinal axis “Z””) and a pair of second outer side surfaces (see outer side surfaces of 14a in Fig. 2) on opposite sides of the second leg member (14), the second inner surface (71) extending laterally from one of the second outer side surfaces on a first portion of the second leg member to the other one of the second outer side surfaces on a second portion of the second leg member (71 extends between the outer side surfaces of 14a), the second leg member (14) having a plurality of teeth (70a-b in Fig. 4A) and a second width in the lateral direction (width of 14 in Fig. 4), wherein the plurality of teeth (70a-b) include a first row of teeth and a second row of teeth (rows 70a and 70b), wherein the first and second rows of teeth (70a-b) are configured to receive the first inner surface (62) of the first leg member (12) therebetween when the surgical clip is in a closed configuration (see Fig. 3).
However, Thomas et al. fails to disclose wherein the first width is greater than the first thickness along at least half of the first length.
In the same field of surgical clips (abstract), Barker et al. teaches a surgical clip comprising a first width (dimension ‘X’ in Fig. 6A), a first thickness (dimension ‘Z’ in Fig. 4B), and a first length (dimension ‘Y’ in Fig. 6A), wherein the first width (X) is greater than the first thickness (Z) along at least half of the first length (Y, PP [0080]: “in the second embodiment of clip where the width, length and height of the clip are referenced “X”, “Y”, and “Z” respectively, the height “Z” of the closed clip is fairly small and is smaller than the width “X” and length “Y” of the clip”).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date to have modified the Thomas et al. device to incorporate the teachings of Barker et al. and include wherein the first width is greater than the first thickness along at least half of the first length. One of ordinary skill in the art would have been motivated to perform this modification because Barker et al. teaches that providing a clip comprising a greater width helps to improve clip security and reduce the likelihood of the clip damaging the vessel wall (Barker et al. PP [0066]), which would not alter the main operating principle of the Thomas et al. device but would simply prevent damage while ensuring stability as taught by the Barker et al. reference.
Regarding claim 17, Thomas et al. as modified by Barker et al. further discloses wherein the at least one first lateral protrusion (overhang of body 14a, see annotated Fig. 4 of Thomas et al. above) extends at least two-thirds of the first length of the first leg (12, see Fig. 1, the overhang extends the entire length of first leg 12).
Regarding claim 18, Thomas et al. as modified by Barker et al. further discloses wherein the first row of teeth and the second row of teeth (70a-b in Figs. 4 and 4A of Thomas et al.) are staggered longitudinally (see Fig. 4A, 70a-b are staggered).
Regarding claim 19, Thomas et al. as modified by Barker et al. further discloses a heel (16a in Fig. 1 of Thomas et al.) at a proximal portion of the second leg member (14), the heel (16a) configured to increase securement of tissue (PP [0036]: “The through bore 16a also allows for substantially complete closure of the proximal portions of the first and second jaws 12, 14”, this complete closure increases securement of tissue).
Regarding claim 20, Thomas et al. as modified by Barker et al. further discloses wherein the first curvature of the first inner surface (62 in Fig. 4 of Thomas et al.) is a concave curvature extending from a proximal portion to a distal portion of the first leg member (12), and the second curvature of the second inner surface (71 in Fig. 4) is a convex curvature extending from a proximal portion to a distal portion of the second leg member (14).
Allowable Subject Matter
Claims 5 and 7 are 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 subject matter of claims 5 and 7 filed on 3/02/2026 could either not be found or was not suggested in the prior art of record.
With respect to claim 5, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of wherein a distal end of the at least one first lateral protrusion of the first leg member is proximal of the at least one boss member, in combination with the other limitations of the independent claim.
The closest prior art is Thomas et al., which discloses each of the limitations as described above.
However, Thomas et al. fails to disclose wherein a distal end of the at least one first lateral protrusion of the first leg member is proximal of the at least one boss member since the lateral protrusion (overhang of body 12a in Fig. 1, see annotated Fig. 4 above) extends to and meets the boss member (32, see Figs. 2A and 5 to see the overhang of body 12a extend to and past boss member 32). Furthermore, the prior art of record does not suggest any motivation to modify the Thomas et al. disclosure to arrive at these features.
With respect to claim 7, the prior art does not disclose or render obvious at the effective filing date of the invention: the feature of wherein a proximal end of the at least one first lateral protrusion of the first leg member is distal of the hinge member, in combination with the other limitations of the independent claim.
The closest prior art is Thomas et al., which discloses each of the limitations as described above.
However, Thomas et al. fails to disclose wherein a proximal end of the at least one first lateral protrusion of the first leg member is distal of the hinge member since the lateral protrusion (overhang of body 12a in Fig. 1, see annotated Fig. 4 above) extends to and meets the hinge member (see overhang extending to and overlapping with hinge 16 in Fig. 4). Furthermore, the prior art of record does not suggest any motivation to modify the Thomas et al. disclosure to arrive at these features.
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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/BRIDGET E. RABAGLIA/Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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