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 Arguments
This Office action is in response to the applicant’s communication filed on 12/8/2025. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 9, with respect to Applicant’s amendments to the drawings made in view of the previous objections to the drawings have been fully considered and are persuasive. The previous objections to the drawings have been withdrawn.
Applicant’s arguments, see pages 9-10, with respect to Applicant’s claim amendments made in view of the previous 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn.
Applicant's arguments, see pages 10-12, alleging that Gayzik fails to disclose the clip assembly capable of moving distally with distal movement of the distal portion of the driver have been fully considered but they are not persuasive. It is the Examiner’s position that Gayzik discloses its clip assembly capable of moving distally with distal movement of the distal portion of the driver have been fully considered but they are not persuasive. Gayzik expressly discloses that its distal portion (1354) of the driver is deformable and comprises at least two arms that extend radially outward in a relaxed state (see annotated Fig. 17 below; [0107]). Such radially outward force provided by the deformable member (1354) would provide a frictional/interference fit between the outer surface of the deformable member (1354) and the inner surface if the clip arms (1016a/1016b). The radially outward force is so strong that before the deformable member (1354) moves relative to the clip arms (1016a/1016b) during deployment, the clip arms (1016a/1016b) bend inward as collet (1070) is distally pushed along the clip ([0108]). Additionally and/or in the alternative, the embodiment of Figure 10B of Gayzik expressly teaches two arms of biased deformable members (742’/743’) being disposed within recessed notches (722’/723’) of the clip assembly (720’) that would provide only one-way motion (i.e., only proximal movement) of the distal portion of the driver relative to the clip assembly ([0088]). The deformable members (742’/743’) would allow for distal movement of the clip assembly (720’) with distal movement of the distal portion (742’/743’) of the driver (i.e., free ends of the two deformable member arms 742’/743’ abut/contact the interior walls of the notches/recesses 722’/723’). For at least these reasons, Applicant’s arguments are not persuasive.
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Applicant’s arguments, see page 12, with respect to the deficiencies of the embodiment of Figs. 13A-13E of Gordon have been fully considered and are persuasive. Therefore, the previous prior art rejections based on the embodiment of Figs. 13A-13E of Gordon have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under the embodiment of Figs. 3A-3H of Gordon, as set forth below.
Claim Rejections - 35 USC § 102
Claim(s) 1 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gordon et al. (US 2011/0077668).
Gordon discloses (see Figs. 3A-3H) a medical clip system comprising the following claim limitations:
(claim 1) An endoscopic device (10) comprising a clip assembly (40) comprising a first jaw (42a); a second jaw (42b); and a release portion (i.e., at 46) connecting a proximal portion of the first jaw (42a) and a proximal portion of the second jaw (42b) (as shown in Figs. 3A-3H), the release portion (46) including an opening (as expressly shown in Figs. 3A-3H) extending through a proximal end of the release portion (46) (as shown in Figs. 3A-3H); and a driving assembly (22/24/26/28/35) operably interfacing with the clip assembly (40) (as shown in Figs. 3A-3H), the driving assembly comprising a sheath (35); and a driver (22/24/26/28) movably disposed within the sheath (35) (as shown in Figs. 3C-3D; [0056]), a distal portion (24/26/28) of the driver operably extending through the opening of the release portion (46) (as expressly shown in Figs. 3B-3G); wherein at least one jaw (42a/42b) is movable between an open position (see Figs. 3A-3B and 3D-3G) and a closed position (see Figs. 3C and 3H) via movement of the driver (22/24/26/28) relative to the sheath (35) (as shown in Figs. 3G-3H; [0060]); and wherein the distal portion (24/26/28) of the driver is configured to (i.e. capable of) operatively couple the driving assembly with the clip assembly (40) when the distal portion (24/26/28) of the driver is disposed distally from the opening of the release portion (46) (as expressly shown in Figs. 3B-3G; [0054]; [0057]-[0058]; [0061]) such that the clip assembly (40) moves distally with distal movement of the distal portion (24/26/28) of the driver (as expressly shown between Figs. 3C-3D; [0056]; [0058]) and the distal portion (24/26/28) of the driver is configured to be (i.e., capable of) proximally retracted through the opening of the release portion (46) via a predetermined proximal pull force to decouple the driving assembly (22/24/26/28/35) from the clip assembly (40) (as expressly shown in Figs. 3F-3H; [0060]-[0061]); and
(claim 8) wherein the predetermined pull force is greater than a force which moves the at least one jaw (42a/42b) from the open position (see Figs. 3A-3B and 3D-3G) to the closed position (see Figs. 3C and 3H) (as shown in Figs. 3F-3H; [0060]-[0061]; express disclosure for initial proximal force to move the clip jaws to the closed position, and a subsequent greater force to detach/deploy the clip from the distal portion of the driver).
Claim Rejections - 35 USC § 102 or § 103
Claim(s) 1-3, 6 and 8 are rejected under 35 U.S.C. 102(a)(1) as anticipated by the embodiment of Fig. 17 of Gayzik (US 2010/0016873) or, in the alternative, under 35 U.S.C. 103 as obvious over the embodiment of Fig. 17 of Gayzik (US 2010/0016873) in view of the embodiment of Fig. 10B of Gayzik.
The embodiment of Fig. 17 of Gayzik discloses a medical clip system comprising the following claim limitations:
(claim 1) An endoscopic device comprising: a clip assembly comprising: a first jaw (1016a); a second jaw (1016b); and a release portion (i.e., proximal clip end, i.e. to the “left” of collet 1070 in Fig. 17) connecting a proximal portion of the first jaw (1016a) and a proximal portion of the second jaw (1016b) (as shown in Fig. 17), the release portion including an opening (1028) extending through a proximal end of the release portion (as shown in Fig. 17); and a driving assembly operably interfacing with the clip assembly, the driving assembly comprising a sheath (1040); and a driver (1035/1352/1354) movably disposed within the sheath (1040) (as shown in Fig. 17), a distal portion (1352/1354) of the driver operably extending through the opening (1028) of the release portion (as shown in Fig. 17); wherein at least one jaw is movable between an open position and a closed position via movement of the driver (1035/1352/1354) relative to the sheath (1040) ([0101]-[0108]; proximally pulling operating wire 1350 acts to close jaws and slide collet 1070 over the jaws to the stop members 1025a/1025b); and wherein the distal portion (1352/1354) of the driver is configured to (i.e., capable of) operatively couple the driving assembly with the clip assembly when the distal portion (1352/1354) of the driver is disposed distally from the opening (1028) of the release portion (as shown in Fig. 17; [0107]-[0108]) such that the clip assembly moves distally with distal movement of the distal portion (1352/1354) of the driver (the arguments provided in paragraph 5 above regarding the embodiment of Fig. 17 are repeated herein) and the distal portion (1352/1354) of the driver is configured to be (i.e., capable of) proximally retracted through the opening (1028) of the release portion via a predetermined proximal pull force to decouple the driving assembly from the clip assembly ([0108]; deformable tag arms 1354 expressly are pulled radially inward as it gets proximally pulled back through hole 1028);
(claim 2) wherein the distal portion of the driver includes a tag with a leg (at 1354) extending radially outwardly configured to (i.e., capable of) operably retain the driver in the release portion (as expressly shown in Fig. 17; [0107]-[0108]);
(claim 3) wherein the leg (1354) of the driver is configured to (i.e., capable of) move radially inward via the predetermined proximal pull force such that the distal portion (1354) of the driver is retractable through the opening (1028) of the release portion ([0107]-[0108]; proximal retraction expressly disclosed);
(claim 6) wherein a laterally outer portion of at least one jaw (1016a/1016b) includes a retention fin (1025a/1025b) configured to (i.e., capable of) prevent a collar (1070) from sliding away from a distal end of the at least one jaw (1016a/1016b) ([0107]-[0108]; fins/stops 1025a/1025b expressly disclosed to prevent collet 1070 from sliding off the distal ends of the jaws 1016a/1016b); and
(claim 8) wherein the predetermined pull force is greater than a force which moves the at least one jaw (1016a/1016b) from the open position to the closed position (as shown in Fig. 17; [0107]-[0108]; first level of force moves collet 1070 and closes the jaws 1016a/1016b, wherein thereafter a greater second level of force deforms the tag 1354 inward to release the clip from the driver and shaft).
If the deformable distal portion (1354) of the embodiment of Fig. 17 of Gayzik is determined to not disclose a coupling configured to move the clip assembly distally with distal movement of the distal portion of the driver, as applied above, then claims 1-3, 6 and 8 are rejected under 35 U.S.C. 103 as obvious over the embodiment of Fig. 17 of Gayzik (US 2010/0016873) in view of the embodiment of Fig. 10B of Gayzik.
The embodiment of Fig. 17 of Gayzik discloses a medical clip system comprising all the limitations of the claim except for the clip assembly configured to more distally with distal movement of the distal portion of the driver. The embodiment of Fig. 10B of Gayzik teaches a highly similar medical clip system comprising a clip assembly (720’) configured to (i.e., capable of) more distally with distal movement of the distal portion (742’/743’) of the driver (as shown in Fig. 10B, biased deformable elements 742’/743’ are disposed within notches/recesses 722’/723’ allowing for one-way proximal movement of the distal portion of the driver relative to the clip assembly). Accordingly, the embodiment of Fig. 10B of Gayzik teaches that it is known that a distal portion of a driver being disposed within notches/recesses of a clip assembly and a distal portion of a driver not being disposed within notches/recesses of a clip assembly are elements that are functional equivalents for providing a releasable/detachable connection between a driver and a clip assembly wherein proximal driver movement over a force level threshold deploys the clip assembly from the distal portion of the driver. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the clip assembly having notches/recesses taught by the embodiment of Fig. 10B of Gayzik for the clip assembly not having notches/recesses of the embodiment of Fig. 17 of Gayzik because both elements were known equivalents for providing a releasable/detachable connection between a driver and a clip assembly wherein proximal driver movement over a force level threshold deploys the clip assembly from the distal portion of the driver within the medical clip art. The substitution would have resulted in the predictable results of providing a releasable/detachable connection between a driver and a clip assembly wherein proximal driver movement over a force level threshold deploys the clip assembly from the distal portion of the driver to the device of the embodiment of Fig. 17 of Gayzik.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771