DETAILED ACTION
This action is in response to applicant's preliminary amendments filed 06/02/25.
The examiner acknowledges the amendments to the claims.
Claims 1-20 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 .
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.
Claims 1-12 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ortiz et al., hereinafter “Ortiz” (U.S. Pat. No. 5,163,945).
Regarding claim 1, Ortiz discloses a clip applier configured to apply a surgical clip to tissue, the clip applier comprising:
a first jaw member 24 (Figures 7-8, 10-11) configured to engage a distal portion of a first leg member of the surgical clip 12;
a second jaw member (opposite 24) configured to engage a distal portion of a second leg member of the surgical clip (Id.);
a first stabilizing member 34 (see annotated Figure 7 below) extending from a first proximal portion of the first jaw member toward the second jaw member (Figures 10-11; flanges 34 extend radially inwards towards an opposing jaw member);
a second stabilizing member (another 34; see annotated Figure 7 below) extending from a second proximal portion of the second jaw member toward the first jaw member (Figures 10-11);
wherein the first and second stabilizing members 34 define a space therebetween (see annotated Figure 7 below) configured to receive a proximal portion of the surgical clip 12 and to reduce lateral movement of the proximal portion of the surgical clip (Figure 8; flanges 34 are positioned on either side of clip 12 to reduce lateral movement).
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Regarding claim 2, Ortiz discloses the first stabilizing member 34 is integral to the first jaw member 24 (flanges 34 are connected on each jaw 24, and therefore are integral) and the second stabilizing member is integral to the second jaw member (Id.).
Regarding claims 3-5, Ortiz discloses the first stabilizing member 34 comprises a first wall having a first flat inner surface (see radially inward facing surface; col. 5, lines 8-10: flanges 34 are flat, parallel, and spaced by a dimension), and the second stabilizing member comprises a second wall having a second flat inner surface (Id.), wherein the first flat inner surface of the first wall is parallel to the second flat inner surface of the second wall (Id.), wherein the first and second walls have spaced apart proximal and distal ends (Id.).
Regarding claims 6-9, Ortiz discloses the first jaw member 24 comprises a first distal portion including at least one first recess 28 (Figures 7-8, 10-11), the at least one first recess configured to receive a first boss member 16 on a first portion of a first leg member of the surgical clip, and the second jaw member comprises a second distal portion including at least one second recess (opposite 28), the at least one second recess configured to receive a second boss member (other 16) on a second portion of a second leg member of the surgical clip, wherein the at least one first recess and the at least one second recess comprise semi-circular grooves (see semi-circular cross-sectional grooves 28 in Figures 10-11), wherein the at least one first recess 28 extends transversely through the first jaw member (see Figure 7), and the at least one second recess extends transversely through the second jaw member (Id.), wherein the at least one first recess is configured to receive the first boss member on the first leg member of the surgical clip in an interference or snap-fit (col. 4, lines 23-26), and the at least one second recess is configured to receive the second boss member on the second leg member of the surgical clip in an interference or snap-fit (Id.).
Regarding claims 10-12, Ortiz discloses the first and second stabilizing members 34 do not proximally abut the proximal portion of the surgical clip when the first and second jaw members are in an open configuration (see proximalmost hinge portion of surgical clip 12 in Figures 8, 10 that is positioned away from the flanges 34), wherein the first and second stabilizing members do not proximally abut the proximal portion of the surgical clip when the first and second jaw members are in a closed configuration (Id. in Figure 11).
Regarding claim 19, Ortiz discloses the first stabilizing member 34 includes a first inner portion that overlaps the proximal portion of the surgical clip (in a lateral direction, as seen in Figure 8) when the first and second jaw members are in an open configuration, and the second stabilizing member includes a second inner portion that overlaps the proximal portion of the surgical clip when the first and second jaw members are in the open configuration (Id.).
Claims 1-2, 10, 13, 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burbank, III et al., hereinafter “Burbank” (U.S. Pat. No. 5,431,668).
Regarding claim 1, Burbank discloses a clip applier configured to apply a surgical clip to tissue, the clip applier comprising:
a first jaw member 12 (Figures 9-10) configured to engage a distal portion of a first leg member of the surgical clip 14;
a second jaw member (other 12) configured to engage a distal portion of a second leg member of the surgical clip (Id.);
a first stabilizing member (protruding surface of proximal end 120 of first jaw member) extending from a first proximal portion of the first jaw member toward the second jaw member (Id.);
a second stabilizing member (other protruding surface of proximal end 120 of second jaw member) extending from a second proximal portion of the second jaw member toward the first jaw member (Id.);
wherein the first and second stabilizing members define a space therebetween (see space between 120 in Figure 9) configured to receive a proximal portion of the surgical clip and to reduce lateral movement of the proximal portion of the surgical clip (since proximal ends 120 are positioned on either side of proximal portion of surgical clip 14).
Regarding claim 2, Burbank discloses the first stabilizing member 120 is integral to the first jaw member and the second stabilizing member 120 is integral to the second jaw member (Figures 9-10).
Regarding claim 10, Burbank discloses the first and second stabilizing members 120 do not proximally abut the proximal portion of the surgical clip when the first and second jaw members are in an open configuration (see open position in Figure 9 where the first and second stabilizing members 120 are spaced from proximal portion of surgical clip 14).
Regarding claim 13, Burbank discloses the first jaw member 12 includes a first inner surface (facing radially inward surface towards opposite second jaw member 12), the first stabilizing member 120 extending from the first inner surface (Figures 9-10), and the second jaw member includes a second inner surface, the second stabilizing member extending from the second inner surface (Id.).
Regarding claim 19, Burbank discloses the first stabilizing member 120 includes a first inner portion that overlaps the proximal portion of the surgical clip (in a lateral direction, as seen in Figure 9) when the first and second jaw members are in an open configuration, and the second stabilizing member includes a second inner portion that overlaps the proximal portion of the surgical clip when the first and second jaw members are in the open configuration (Id.).
Regarding claim 20, Burbank discloses wherein the first and second stabilizing members 120 are configured to slide over the proximal portion of the surgical clip as the first and second jaw members move to a closed configuration (moving from the position in Figure 9 to the position in Figure 10 the first and second stabilizing members 120 slide into abutment with the proximal portion of the surgical clip 14).
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 1-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9-10 and 21-22 of U.S. Patent No. 11266408 in view of Ortiz (U.S. Pat. No. 5,163,945) or Burbank (U.S. Pat. No. 5,431,668). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements of the claims are to be found in patent claims 9, 21, except for features that are merely obvious. For instance, Ortiz teaches a first stabilizing member 34 (see annotated Figure 7 above) with a first flat inner surface extending from and integral to a first proximal portion of the first jaw member toward the second jaw member (Figures 10-11; flanges 34 extend radially inwards towards an opposing jaw member); a parallel second stabilizing member (another 34; see annotated Figure 7 below) with a second flat inner surface extending from and integral to second proximal portion of the second jaw member toward the first jaw member (Figures 10-11), the first jaw member 24 comprises a first distal portion including at least one semi-circular cross-sectional first recess 28 (Figures 7-8, 10-11) extending transversely through the first jaw member, the at least one first recess configured to receive a first boss member 16 on a first portion of a first leg member of the surgical clip, and the second jaw member comprises a second distal portion including at least one semi-circular cross-sectional second recess (opposite 28) extending transversely through the second jaw member, the at least one second recess configured to receive a second boss member (other 16) on a second portion of a second leg member of the surgical clip, wherein the at least one first and second recesses are configured to receive the first and second boss members on the first and second leg members of the surgical clip in an interference or snap-fit (col. 4, lines 23-26), the first and second stabilizing members 34 do not proximally abut the proximal portion of the surgical clip when the first and second jaw members are in an open configuration (see proximalmost hinge portion of surgical clip 12 in Figures 8, 10 that is positioned away from the flanges 34), wherein the first and second stabilizing members do not proximally abut the proximal portion of the surgical clip when the first and second jaw members are in a closed configuration (Id. in Figure 11), the first stabilizing member 34 includes a first inner portion that overlaps the proximal portion of the surgical clip (in a lateral direction, as seen in Figure 8) when the first and second jaw members are in an open configuration, and the second stabilizing member includes a second inner portion that overlaps the proximal portion of the surgical clip when the first and second jaw members are in the open configuration (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 Ortiz, in order to suitably cover and protect the upper and lower surfaces of the surgical clip (Ortiz, col. 4, line 67 to col. 5, line 3). Furthermore, Burbank teaches first jaw member 12 includes a first inner surface (facing radially inward surface towards opposite second jaw member 12), the first stabilizing member 120 extending from the first inner surface (Figures 9-10), and the second jaw member includes a second inner surface, the second stabilizing member extending from the second inner surface (Id.), the first and second stabilizing members 120 are configured to slide over the proximal portion of the surgical clip as the first and second jaw members move to a closed configuration (moving from the position in Figure 9 to the position in Figure 10 the first and second stabilizing members 120 slide into abutment with the proximal portion of the surgical clip 14). 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 Burbank, in order to facilitate closure of the surgical clip (Burbank; abstract).
Claims 1-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-7, 10-11, 18-19 of U.S. Patent No. 12064115 in view of Ortiz (U.S. Pat. No. 5,163,945) or Burbank (U.S. Pat. No. 5,431,668). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements of claims are to be found in patent claims 1-2, 4, 6-7, 10-11, 18-19 except for features that are merely obvious.
For instance, Ortiz teaches a first stabilizing member 34 (see annotated Figure 7 above) with a first flat inner surface extending from and integral to a first proximal portion of the first jaw member toward the second jaw member (Figures 10-11; flanges 34 extend radially inwards towards an opposing jaw member); a second stabilizing member (another 34; see annotated Figure 7 below) with a second flat inner surface extending from and integral to second proximal portion of the second jaw member toward the first jaw member (Figures 10-11), the first jaw member 24 comprises a first distal portion including at least one semi-circular cross-sectional first recess 28 (Figures 7-8, 10-11) extending transversely through the first jaw member, the at least one first recess configured to receive a first boss member 16 on a first portion of a first leg member of the surgical clip, and the second jaw member comprises a second distal portion including at least one semi-circular cross-sectional second recess (opposite 28) extending transversely through the second jaw member, the at least one second recess configured to receive a second boss member (other 16) on a second portion of a second leg member of the surgical clip, wherein the at least one first and second recesses are configured to receive the first and second boss members on the first and second leg members of the surgical clip in an interference or snap-fit (col. 4, lines 23-26), the first stabilizing member 34 includes a first inner portion that overlaps the proximal portion of the surgical clip (in a lateral direction, as seen in Figure 8) when the first and second jaw members are in an open configuration, and the second stabilizing member includes a second inner portion that overlaps the proximal portion of the surgical clip when the first and second jaw members are in the open configuration (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 Ortiz, in order to suitably cover and protect the upper and lower surfaces of the surgical clip (Ortiz, col. 4, line 67 to col. 5, line 3). Furthermore, Burbank teaches the first and second stabilizing members 120 are configured to slide over the proximal portion of the surgical clip as the first and second jaw members move to a closed configuration (moving from the position in Figure 9 to the position in Figure 10 the first and second stabilizing members 120 slide into abutment with the proximal portion of the surgical clip 14). 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 Burbank, in order to facilitate closure of the surgical clip (Burbank; abstract).
Claims 1-14 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, 10-11, 13 of U.S. Patent No. 12023041 in view of Ortiz (U.S. Pat. No. 5,163,945) or Burbank (U.S. Pat. No. 5,431,668). Although the claims at issue are not identical, they are not patentably distinct from each other because it is clear that elements of claims are to be found in patent claims 1, 3, 5-6, 10-11, 13 except for features that are merely obvious. For instance, Ortiz teaches a first stabilizing member 34 (see annotated Figure 7 above) with a first flat inner surface extending from and integral to a first proximal portion of the first jaw member toward the second jaw member (Figures 10-11; flanges 34 extend radially inwards towards an opposing jaw member); a parallel second stabilizing member (another 34; see annotated Figure 7 below) with a second flat inner surface extending from and integral to second proximal portion of the second jaw member toward the first jaw member (Figures 10-11), the first jaw member 24 comprises a first distal portion including at least one semi-circular cross-sectional first recess 28 (Figures 7-8, 10-11) extending transversely through the first jaw member, the at least one first recess configured to receive a first boss member 16 on a first portion of a first leg member of the surgical clip, and the second jaw member comprises a second distal portion including at least one semi-circular cross-sectional second recess (opposite 28) extending transversely through the second jaw member, the at least one second recess configured to receive a second boss member (other 16) on a second portion of a second leg member of the surgical clip, wherein the at least one first and second recesses are configured to receive the first and second boss members on the first and second leg members of the surgical clip in an interference or snap-fit (col. 4, lines 23-26), the first and second stabilizing members 34 do not proximally abut the proximal portion of the surgical clip when the first and second jaw members are in an open configuration (see proximalmost hinge portion of surgical clip 12 in Figures 8, 10 that is positioned away from the flanges 34), wherein the first and second stabilizing members do not proximally abut the proximal portion of the surgical clip when the first and second jaw members are in a closed configuration (Id. in Figure 11), the first stabilizing member 34 includes a first inner portion that overlaps the proximal portion of the surgical clip (in a lateral direction, as seen in Figure 8) when the first and second jaw members are in an open configuration, and the second stabilizing member includes a second inner portion that overlaps the proximal portion of the surgical clip when the first and second jaw members are in the open configuration (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 Ortiz, in order to suitably cover and protect the upper and lower surfaces of the surgical clip (Ortiz, col. 4, line 67 to col. 5, line 3). Furthermore, Burbank teaches first jaw member 12 includes a first inner surface (facing radially inward surface towards opposite second jaw member 12), the first stabilizing member 120 extending from the first inner surface (Figures 9-10), and the second jaw member includes a second inner surface, the second stabilizing member extending from the second inner surface (Id.), the first and second stabilizing members 120 are configured to slide over the proximal portion of the surgical clip as the first and second jaw members move to a closed configuration (moving from the position in Figure 9 to the position in Figure 10 the first and second stabilizing members 120 slide into abutment with the proximal portion of the surgical clip 14). 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 Burbank, in order to facilitate closure of the surgical clip (Burbank; abstract).
Allowable Subject Matter
Claim 14 would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims and if a Terminal Disclaimer is filed to overcome the double patent rejections set forth in this office action.
Claims 15-18 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 following is a statement of reasons for the indication of allowable subject matter: None of the prior art of record, alone or in combination, teaches or renders obvious a clip applier including, inter alia, a first stabilizing member extending from a first proximal portion and first inner surface of a first jaw member toward a second jaw member, a second stabilizing member extending from a second proximal portion and second inner surface of the second jaw member toward the first jaw member, wherein the first and second stabilizing members define a space therebetween configured to receive a proximal portion of the surgical clip and to reduce lateral movement of the proximal portion of the surgical clip, wherein the first inner surface of the first jaw member includes a first longitudinal channel configured to receive a portion of the second stabilizing member when the first and second jaw members are in a closed configuration, and the second inner surface of the second jaw member includes a second longitudinal channel configured to receive a portion of the first stabilizing member when the first and second jaw members are in the closed configuration. The first and second stabilizing members in Ortiz and Burbank are not configured to be received in the opposing second and first jaw members, respectively.
Conclusion
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/DIANE D YABUT/Primary Examiner, Art Unit 3771