DETAILED ACTION
Claims 1 and 24 are amended. A complete action on the merits of pending claims 1-3, 5-8, 10-11, and 23-26 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to applicant’s amendments filed on 01/16/2026 which are entered.
Claim Rejections - 35 USC § 103
Claim(s) 1-3, 6-7, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz (US Patent No. 5163945).
Regarding claim 1, Ortiz teaches, a clip applier (Figures 1-2, surgical device/clip applier (10); Col. 3, line 58-61) configured to releasably secure a surgical clip (Figures 8 and 10-11, surgical clip (12); Col. 3, line 61-66) contained in a cavity (Figures 12-13, cavities (80); Col. 6, line 62-63) of a cartridge (Figures 12-13, cartridge (78); Col. 6, line 62-63) (Col. 7, line 50-Col. 8, line 7), the surgical clip (clip (12)) comprising first and second leg members (Figures 8 and 10-11, hinged leg portions (14); Col. 3, line 62-66), the clip applier (surgical device/clip applier (10)) comprising:
a first jaw member (Figures 2, 4, and 6-8, one of the opposing jaw members (24); Col. 4, line 9-11) including a first clip engagement inner portion (Figures 4 and 6-8, clip receiving/closing portions (26); Col. 4, line 11-17), a first cartridge engagement outer portion (Figures 4-5 and 7-8, shield mean (31); Col. 4, line 45-48) and a first channel configured to receive the first leg member of the surgical clip (Col. 4, line 11-17, disclose, the clip receiving/closing portions (26) are configured to receive the leg portions (14) of the surgical clip (12). This corresponds to the claimed “first channel configured to receive the first leg member,” and Figures 7-8 further reinforce the presence of a channel, where a channel is clearly seen at clip receiving/closing portions (26)), the first clip engagement inner portion including at least one recess (Figures 7-8, grooved portion (28)) configured to receive a portion of the first leg member (Figures 8 and 10-11, boss portion (16)) (Col. 4, line 23-26), the first cartridge engagement outer portion including at least one first flange (Figures 7-8, angular flanges (34)) extending laterally of the first clip engagement inner portion and the first channel (Figures 7-8; Col. 5, line 49-63), and the at least one first flange (angular flanges (34)) configured to abut at least one first side surface of the cartridge to align the first jaw member with the first leg member (Figures 12-13 and 15-19; Col. 6, line 62-Col. 7, line 8 and Col. 7, line 36-58, disclose, that the cartridge (78) includes cavities (80) having side walls (90 and 92), and retainer openings (86) defined by parallel side walls (96) and end walls (98), which cooperate with side shield flanges (34) of the jaw members. This disclosure expressly states that the cavity walls, spacer portions, and retaining lips “function together to guide the insertion of the jaw members (24) and side shield flanges (34) into the cavity, similar to the insertion of a key into a keyhole” (Col. 7, line 52-58). Thus, this discloses flanges abutting cartridge side surface to align the jaw with the clip leg member); and
a second jaw member (Figures 2, 4, and 6-8, the other of the opposing jaw members (24); Col. 4, line 9-11) including a second clip engagement inner portion (Figures 4 and 6-8, clip receiving/closing portions (26); Col. 4, line 11-17), a second cartridge engagement outer portion (Figures 4-5 and 7-8, shield mean (31); Col. 4, line 45-48) and a second channel configured to receive the second leg member of the surgical clip (Col. 4, line 11-17, disclose, the clip receiving/closing portions (26) are configured to receive the leg portions (14) of the surgical clip (12). This corresponds to the claimed “first channel configured to receive the first leg member,” and Figures 7-8 further reinforce the presence of a channel, where a channel is clearly seen at clip receiving/closing portions (26)), the second clip engagement inner portion including at least one recess (Figures 7-8, grooved portion (28)) configured to receive a portion of the second leg member (Figures 8 and 10-11, boss portion (16)) (Col. 4, line 23-26), the second cartridge engagement outer portion including at least one second flange (Figures 7-8, angular flanges (34)) extending laterally of the second clip engagement inner portion and the second channel (Figures 7-8; Col. 5, line 49-63), and the at least one second flange (angular flanges (34)) configured to abut at least one second side surface of the cartridge to align the second jaw member with the second leg member (Figures 12-13 and 15-19; Col. 6, line 62-Col. 7, line 8 and Col. 7, line 36-58, disclose, that the cartridge (78) includes cavities (80) having side walls (90 and 92), and retainer openings (86) defined by parallel side walls (96) and end walls (98), which cooperate with side shield flanges (34) of the jaw members. This disclosure expressly states that the cavity walls, spacer portions, and retaining lips “function together to guide the insertion of the jaw members (24) and side shield flanges (34) into the cavity, similar to the insertion of a key into a keyhole” (Col. 7, line 52-58). Thus, this discloses flanges abutting cartridge side surface to align the jaw with the clip leg member).
Ortiz does not expressly teach that the flanges have a first inner surface and a second inner surface configured to abut the respective side surface of the cartridge.
However, configuring the flanges such that their inner surfaces (the faces oriented toward the opposing jaw/clip centerline) are arranged to abut a side surface of the cartridge would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Ortiz teaches that the flanges (34) and cavity side walls cooperate to guide and align the jaws with the clip during loading in a “key-in-keyhole” manner (Col. 7, line 52-58). This alignment function is achieved via contact between portions of the flanges and cartridge surfaces. Reorienting or redesigning the flanges so that their inner surfaces (rather than solely outer edges) directly abut cartridge side surfaces is merely a reversal of parts or obvious design choice to achieve the same predictable result of guiding/aligning the jaws to the clip leg members during pickup.
In re Einstein, 8 USPQ 167 (CCPA 1931) (reversal of parts is obvious where the same function is achieved); MPEP § 2144.04 (VI)(A). One of ordinary skill would have been motivated to make this modification to provide more positive, pre-insertion alignment and reduce the risk of misalignment during the initial descent of the jaws into the cavity, particularly given the small size of surgical clips and the need for reliable boss engagement as admitted in the background of the present disclosure (Paragraph [0004]). See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obvious to apply known technique to a known device ready for improvement to yield predictable results).
Regarding claim 2, Ortiz further teaches, wherein: the first cartridge engagement outer portion has a width greater than a width of the first clip engagement inner portion, and the second cartridge engagement outer portion has a width greater than a width of the second clip engagement inner portion (Figure 7 shows side shield means (31) which include angular flanges (34) extending laterally outward beyond the width of the clip receiving portions (26) (Col. 4, line 45-57 and Col. 4, line 64-Col. 5, line 12). Thus, side shield means (31) (outer cartridge engagement portions) which include angular flanges (34) are clearly wider than the inner clip engagement portions (clip receiving portion (26)).
Regarding claim 3, Ortiz further teaches, wherein the at least one recess of the first clip engagement inner portion and the at least one recess of the second clip engagement inner portion (grooved portions (28)) are configured to be inserted into the cavity (cavities (80) in cartridge (78)) to engage the surgical clip (surgical clip (12)) while the at least one first flange and the at least one second flange (angular flanges (34)) remain outside of the cavity (Figures 13 and 18; Col. 6, line 62-68, disclose, cartridge (78) includes cavities (80) with retainer openings (86). The jaw recesses (28) enter the cavity to engage the clip, while side shield flanges (34) cooperate with side walls (90, 92, & 96) that remain outside the cavity (Figures 13 and 18) like key guides (Col. 7, line 50-58)).
Regarding claim 6, Ortiz further teaches, wherein the at least one first flange comprises a pair of first flanges extending in opposing lateral directions of the first clip engagement inner portion, and wherein the at least one second flange comprises a pair of second flanges extending in opposing lateral directions of the second clip engagement inner portion (Side shield means (31) include angular flanges (34) that extend laterally from opposite sides of the jaw (Figure 7; Col. 4, line 45-63). Both jaws have these paired flanges).
Regarding claim 7, Ortiz further teaches, wherein the at least one first flange is at least partially tapered, and the at least one second flange is at least partially tapered (Figures 7-8 and Col. 4, line 49-63, show/disclose, the flanges (34) as angled/tapered).
Regarding claim 11, Ortiz further teaches, wherein the at least one first flange and the at least one second flange (angular flanges (34)) form a V-shape when the clip applier (surgical device/clip applier (10)) is in an open configuration (Figures 4, 6-8 and 18 show jaws (24) spreading apart, with flanges (34)/surfaces (35) angling outward to form a V-shape).
Claim(s) 5, 8, 10, and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz, in view of Patel (US PGPUB No. 20120083803 A1).
Regarding claim 5, Ortiz teaches, the at least one recess (grooved portion (28)) of the first clip engagement inner portion (clip receiving/closing portion (26)) configured to receive a boss (boss portion (16)) on the first leg member (hinged leg portion (14)) (Col. 4, line 23-26), and the at least one recess (grooved portion (28)) of the second clip engagement inner portion (clip receiving/closing portion (26)) to receive a boss (boss portion (16)) on the second leg member (hinged leg portion (14)) (Col. 4, line 23-26).
Ortiz fails to teach, wherein the at least one recess of the first clip engagement inner portion comprises first and second spaced apart recesses configured to receive first and second bosses on the first leg member, and the at least one recess of the second clip engagement inner portion comprises first and second spaced apart recesses configured to receive first and second bosses on the second leg member.
Patel discloses, a clip applicator and a surgical clip. Patel teaches, jaws of a surgical clip applier having a generally U-shaped cross section such that there are opposing spaced apart parallel walls (Figures 19-22, opposed hinged jaws (830 & 835); Paragraph [0069]) each provided with recesses (Figure 20, cutouts (880 & 885); Paragraph [0069]) at their respective upper edges for receiving bosses of a surgical clip (See Figures 20 and 22; Paragraphs [0061]-[0070]). Thus, these cutouts constitute the claimed “first and second spaced-apart recesses” that are “configured to receive first and second bosses” on each of the first leg member and the second leg member.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the jaws of Ortiz to include the dual, spaced-apart recesses of Patel, as both references and the claimed invention are directed to clip applicators and surgical clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the jaws of Ortiz to include the dual, spaced-apart recesses of Patel, as such a modification would have been predictable, namely, to improve engagement and stabilization of the surgical clip during application, as indicated by Patel.
Regarding claim 8, Ortiz teaches, the first and second jaw members (opposing jaw members (24)) of the clip applier (surgical device/clip applier (10)); and the surgical clip (surgical clip (12)).
Ortiz fails to teach, wherein the clip applier includes first and second protrusions on at least one of the first and second jaw members, the clip applier being configured to receive a proximal portion of the surgical clip between the first and second protrusions to laterally stabilize a proximal portion of the surgical clip.
Patel teaches, jaws with opposing walls (opposed hinged jaws (830 & 835)) that act as protrusions, defining a channel for receiving the proximal portion of the surgical clip between them, thereby laterally stabilizing the proximal portion (See Figures 20 and 22; Paragraphs [0065]-[0070]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to incorporate the parallel protrusions of Patel into the jaws of Ortiz, as both references and the claimed invention are directed to clip applicators and surgical clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the parallel protrusions of Patel into the jaws of Ortiz, as such a modification would have been predictable, namely, to laterally stabilize the proximal portion of the clip during application.
Regarding claim 10, Ortiz teaches, the first and second jaw members (opposing jaw members (24)) of the clip applier (surgical device/clip applier (10)).
Ortiz fails to teach, wherein the first and second protrusions extend from an attachment portion of the at least one of the first and second jaw members, and the first and second protrusions have a width less than a width of the attachment portion.
Patel teaches, U-shaped jaws (Paragraph [0069]) in which the opposing walls (the protrusions) extend upward from a broader base portion (attachment portion), and the walls each have a width less than the overall base portion (See Figures 20 and 22).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to incorporate the parallel protrusions of Patel into the jaws of Ortiz, which are configured to extend from an attachment portion/base with reduced width as taught by Patel, as both references and the claimed invention are directed to clip applicators and surgical clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the parallel protrusions of Patel into the jaws of Ortiz, which are configured to extend from an attachment portion/base with reduced width as taught by Patel, as such a modification would have been predictable, namely, since such a design provides mechanical strength at the jaw base while maintaining a narrow engagement interface to properly seat the clip bosses.
Regarding claim 23, Ortiz teaches, the first and second jaw members (opposing jaw members (24)) of the clip applier (surgical device/clip applier (10)) for engaging the clip (clip (12)).
Ortiz fails to teach, wherein the first protrusion is on the first jaw member, and the second protrusion is on the second jaw member.
Patel teaches, first and second jaws (opposed hinged jaws (830 & 835)), each including a protrusion (wall) such that a proximal portion of the clip is received between the opposing protrusions of the respective jaws (See Figures 20 and 22; Paragraphs [0069]-[0070]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to provide the first protrusion on the first jaw member and the second protrusion on the second jaw member in Ortiz as taught by Patel, as both references and the claimed invention are directed to clip applicators and surgical clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the first protrusion on the first jaw member and the second protrusion on the second jaw member in Ortiz as taught by Patel, as such a modification would have been predictable, namely, to achieve lateral stabilization of the clip.
Regarding claim 24, Ortiz teaches, a clip applier (Figures 1-2, surgical device/clip applier (10); Col. 3, line 58-61) configured to releasably secure a surgical clip (Figures 8 and 10-11, surgical clip (12); Col. 3, line 61-66) contained in a cavity (Figures 12-13, cavities (80); Col. 6, line 62-63) of a cartridge (Figures 12-13, cartridge (78); Col. 6, line 62-63) (Col. 7, line 50-Col. 8, line 7), the surgical clip (clip (12)) comprising first and second leg members (Figures 8 and 10-11, hinged leg portions (14); Col. 3, line 62-66), the clip applier (surgical device/clip applier (10)) comprising:
a first jaw member (Figures 2, 4, and 6-8, one of the opposing jaw members (24); Col. 4, line 9-11) including: a first clip engagement portion (Figures 4 and 6-8, clip receiving/closing portions (26); Col. 4, line 11-17) configured to engage the first leg member (Figures 8 and 10-11; Col. 4, line 11-17), and a first cartridge engagement portion (Figures 4-5 and 7-8, shield mean (31); Col. 4, line 45-48) including at least one first flange (Figures 7-8, angular flanges (34)) extending laterally of the first clip engagement portion (Figures 7-8; Col. 5, line 49-63), the at least one first flange (angular flanges (34)) configured to abut a first side surface of the cartridge to align the first jaw member with the first leg member (Figures 12-13 and 15-19; Col. 6, line 62-Col. 7, line 8 and Col. 7, line 36-58, disclose, that the cartridge (78) includes cavities (80) having side walls (90 and 92), and retainer openings (86) defined by parallel side walls (96) and end walls (98), which cooperate with side shield flanges (34) of the jaw members. This disclosure expressly states that the cavity walls, spacer portions, and retaining lips “function together to guide the insertion of the jaw members (24) and side shield flanges (34) into the cavity, similar to the insertion of a key into a keyhole” (Col. 7, line 52-58). Thus, this discloses flanges abutting cartridge side surface to align the jaw with the clip leg member); and
a second jaw member (Figures 2, 4, and 6-8, the other of the opposing jaw members (24); Col. 4, line 9-11) including: a second clip engagement portion (Figures 4 and 6-8, clip receiving/closing portions (26); Col. 4, line 11-17) configured to engage the second leg member (Figures 8 and 10-11; Col. 4, line 11-17), and a second cartridge engagement portion (Figures 4-5 and 7-8, shield mean (31); Col. 4, line 45-48) including at least one second flange (Figures 7-8, angular flanges (34)) extending laterally of the second clip engagement portion (Figures 7-8; Col. 5, line 49-63), the at least one second flange (Figures 7-8; Col. 5, line 49-63) configured to abut a second side surface of the cartridge to align the second jaw member with the second leg member (Figures 12-13 and 15-19; Col. 6, line 62-Col. 7, line 8 and Col. 7, line 36-58, disclose, that the cartridge (78) includes cavities (80) having side walls (90 and 92), and retainer openings (86) defined by parallel side walls (96) and end walls (98), which cooperate with side shield flanges (34) of the jaw members. This disclosure expressly states that the cavity walls, spacer portions, and retaining lips “function together to guide the insertion of the jaw members (24) and side shield flanges (34) into the cavity, similar to the insertion of a key into a keyhole” (Col. 7, line 52-58). Thus, this discloses flanges abutting cartridge side surface to align the jaw with the clip leg member).
As discussed above with respect to claim 1, configuring the flanges to have an inner surface configured to abut the cartridge side surface would have been obvious as a reversal of parts or obvious design choice for the same alignment function.
Ortiz fails to teach, wherein the clip applier includes first and second protrusions integrally formed on at least one of the first and second jaw members, the at least one first flange and the at least one second flange extending laterally from the first and second protrusions, and the clip applier being configured to receive a proximal portion of the surgical clip between the first and second protrusions to laterally stabilize a proximal portion of the surgical clip.
Patel teaches, a surgical clip applier with jaws having a U-shaped cross section, each including first and second protrusions (opposite walls) integrally formed with the jaw (Figures 20 and 22; Paragraphs [0061]-[0070]). The opposing protrusions/walls are configured to receive a proximal portion of the surgical clip therebetween to laterally stabilize the clip during application (Paragraphs [0065]-[0070]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the jaws of Ortiz to include the protrusions taught by Patel, such that the at least one first flange and the at least one second flange taught by Ortiz extend laterally from the first and second protrusions taught by Patel, allowing the clip applier to receive a proximal portion of the surgical clip between the first and second protrusions to laterally stabilize a proximal portion of the surgical clip, as both references and the claimed invention are directed to clip applicators and surgical clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the jaws of Ortiz to include the protrusions taught by Patel, such that the at least one first flange and the at least one second flange taught by Ortiz extend laterally from the first and second protrusions taught by Patel, allowing the clip applier to receive a proximal portion of the surgical clip between the first and second protrusions to laterally stabilize a proximal portion of the surgical clip, as such a modification would have been predictable, namely, merely substitute one known jaw structure (U-shaped taught by Patel) for another known jaw structure (Solid one piece taught by Ortiz), yielding predictable results, such as, providing improved lateral stabilization of the clip and improving alignment of the jaws relative to the cartridge and the clip leg members, consistent with the teachings of both references. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The inner surface abutment is obvious over Ortiz alone as set forth above.
Regarding claim 25, Ortiz further teaches, wherein the first clip engagement portion (clip receiving/closing portions (26)) includes at least one recess (Figures 7-8, grooved portion (28)) configured to receive a portion of the first leg member (Figures 8 and 10-11, boss portion (16)) (Col. 4, line 23-26), and the second clip engagement portion (clip receiving/closing portions (26)) includes at least one recess (Figures 7-8, grooved portion (28)) configured to receive a portion of the second leg member (Figures 8 and 10-11, boss portion (16)) (Col. 4, line 23-26).
Regarding claim 26, Ortiz teaches, the first and second jaw members (opposing jaw members (24)) of the clip applier (surgical device/clip applier (10)) for engaging the clip (clip (12)).
Ortiz fails to teach, wherein the first protrusion is on the first jaw member, and the second protrusion is on the second jaw member.
Patel teaches, first and second jaws (opposed hinged jaws (830 & 835)), each including a protrusion (wall) such that a proximal portion of the clip is received between the opposing protrusions of the respective jaws (See Figures 20 and 22; Paragraphs [0069]-[0070]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to provide the first protrusion on the first jaw member and the second protrusion on the second jaw member in Ortiz as taught by Patel, as both references and the claimed invention are directed to clip applicators and surgical clips. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the first protrusion on the first jaw member and the second protrusion on the second jaw member in Ortiz as taught by Patel, as such a modification would have been predictable, namely, to achieve lateral stabilization of the clip.
Response to Arguments
Applicant’s arguments, see pages 1-2 of Applicant’s remarks, filed 01/16/2026, with respect to claims 1 and 24 have been fully considered and are persuasive.
The Examiner agrees that Ortiz does not expressly or inherently disclose flanges having an inner surface configured to abut a side surface of the cartridge, as the flanges (34) are inwardly extending side shields whose inner (clip-facing) surfaces engage the clip for retention/protection (Figures 7-8, & 18; Co. 4, line 64-Col. 5, line 11), while alignment/guidance during loading occurs via outer edges or lateral faces of the flanges being constrained by internal cavity walls (Figure 13; Col. 7, line 52-58). Accordingly, the 35 U.S.C. 102 rejection of claims 1-3, 6-7, and 11 over Ortiz is withdrawn.
However, Applicant’s arguments are not persuasive with respect to obviousness under 35 U.S.C. 103. The limitation directed to the flange having an inner surface configured to abut a side surface of the cartridge does not patentably distinguish over Ortiz. As explained in the updated rejections above, reorienting the flanges of Ortiz so that their inner surfaces (rather than outer edges) abut cartridge side surfaces for alignment is an obvious reversal of parts or design choice yielding the predictable result of jaw-to-clip alignment during loading. No criticality has been shown for using the inner surface specifically, and the function (guidance/alignment) remains the same. See In re Einstein (reversal obvious); KSR (predictable results from known techniques).
The combination with Patel for the protrusions/stabilization feature is maintained for the reasons previously stated and is not affected by the amendment.
See updated rejections above.
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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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771