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
Claims filed on March 15th, 2026 have been entered. Claims 1 and 3- 21 are pending in the applications. Claims 11- 15 and 22 remain withdrawn from consideration for being drawn to an unelected invention. The amendments to claims 3-10 overcome the previous claim objections and the amendment to claim 10 overcomes the previous 35 U.S.C. 112(b) rejection.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The rejection of claims 1 and 17-19 under 35 U.S.C. 102(a)(1) over Paz et al. (US 2007/0088390) has been withdrawn in light of applicant’s amendments; specifically Paz does not teach a series of cartridges, arranged along the extracorporeal unit or a series of anchors being held in a corresponding cartridge of the series of cartridges.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3- 10, 16- 19, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz et al. (US 2007/0088390).
Regarding claim 1, Paz (Paz et al.) teaches a system (1)(Figs. 6- 8) for use with a tissue of a subject (abstract), the system comprising: a catheter device (75, 63, filament 10, anchors 50), comprising: a tube (75) that has: a distal opening that is configured to be transluminally advanced to the tissue (see annotated Fig. 6 below), and a proximal end that defines a proximal opening (see annotated Fig. 8 below), an extracorporeal unit (magazine 63) that is coupled to the proximal end of the tube (Paragraph 0081), a series of cartridges (shell 69), arranged along the extracorporeal unit (see annotated Fig. 8 below) and an implant (filament 10, anchor 50), comprising: a series of anchors, including a first anchor and other anchors, the series of anchors being arranged along the extracorporeal unit (see annotated Fig. 8 below)(Paragraphs 0081 and 0082), each of the anchors being held in a corresponding cartridge of the series of cartridges (see annotated Fig. 8 below)(Paragraphs 0081 and 0082); comprising a tissue- engaging element (53), and comprising a head (see annotated Fig. 4 below), and a tether (filament 10) that extends along the extracorporeal unit (see annotated Fig. 6 below).
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Paz does not teach in the current embodiment an anchor comprising a head with an eyelet, wherein the tether extends through the eyelet of each of the other anchors to the first anchor such that: the first anchor is advanceable, with a distal end of the tether, distally into the proximal opening and through the tube toward the tissue, and subsequentially, the other anchors are slidable, sequentially over and along the tether, distally into the proximal opening and through the tube toward the first anchor.
Paz teaches in a different embodiment, a system (100)(Figs. 5a- 5b and 11-15c) for use with a tissue of a subject (abstract), the system comprising: a catheter device (barrel 102, fasteners 55, filament 109), comprising: a tube (barrel 102) that has: a distal opening that is configured to be transluminally advanced to the tissue (see annotated Fig. 11a below)(Paragraphs 0069 and 0071), and a proximal end (105) and an implant (fasteners 55, filament 109), comprising: a series of anchors, including a first anchor and other anchors (see annotated Fig. 13 below), each of the anchors comprising: a tissue- engaging element (58), and a head that defines an eyelet (see annotated Fig. 5b), and a tether (filament 109) that extends through the eyelet of each of the other anchors to the first anchor (see annotated Fig. 13 below) such that: the first anchor is advanceable, with a distal end of the tether, distally through the tube toward the tissue, and subsequentially, the other anchors are slidable, sequentially over and along the tether, distally into the proximal opening and through the tube toward the first anchor (Paragraphs 0070, 0072, 0073, and 0074).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the tether as taught by the first embodiment to be the tether that is threaded through the eyelet of each of the anchors as taught by the second embodiment of Paz for the purpose of advancing the anchors along the tube and connecting the anchors within the body (Paz, Paragraphs 0070- 0074 and 0085). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one tether for another because both tethers are disclosed as equivalent structures for advancing anchors along the tube and connecting them within the body (Paz, Paragraphs 0070- 0074 and 0085) and substitution of one for the other would have resulted in the predictable result of connecting the eyelets of the anchors when they are deployed within tissue (Paz, Paragraphs 0070- 0074 and 0085). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
It would have been obvious to one of ordinary skill in the art to modify the anchors as taught by the first embodiment to be the anchors as taught by the second embodiment of Paz since Paz teaches that the anchor of the second embodiment firmly attaches to the tissue (Paragraph 0078) and as Paz teaches that the cartridge (shell 69) is capable of holding the anchor as it can be sized for any anchor (Paragraph 0081). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one anchor for another because both anchors are disclosed as equivalent structures for attaching tissue in the body (Paz, abstract and Paragraphs 0065, 0066, and 0071) and substitution of one for the other would have resulted in the predictable result of securing tissue within the body (Paz, abstract and Paragraphs 0065, 0066, and 0071). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the tether extending through the eyelet of each of the other anchors to the first anchor, as the combination would have the tether extending through the middle of each of the anchors and the cartridges (shell 69) and as Paz teaches that in the first embodiment that there is a reel of filament disposed within the magazine (Paragraph 0085), then it would be obvious that the filament would extend through each anchor and cartridge within the magazine.
Regarding claim 3, Paz makes obvious the system as discussed above.
Regarding wherein for each of the cartridges, the cartridge has an initial position which inhibits sliding of the corresponding anchor with respect to the extracorporeal unit, Paz teaches that when the cartridge is within the extracorporeal unit, the anchor is incapable of sliding since it is blocked by the wall of the unit (see annotated Fig. 8 below).
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Regarding for each of the cartridges remaining coupled to the extracorporeal unit, and actuatable in a manner that releases the corresponding anchor from the cartridge, Paz teaches that the cartridges are indirectly coupled to the extracorporeal unit, and are able to be actuated to release the anchor (Paragraphs 0081 and 0082).
Regarding claim 4, Paz makes obvious the system as discussed above.
Regarding wherein for each of the cartridges, the cartridge is configured such that actuation of the cartridge spaces the corresponding anchor from a barrier that, in the initial position of the cartridge, obstructs the corresponding anchor from being advanced distally out of the cartridge, as Paz teaches that the cartridges are arranged within the extracorporeal unit, the wall of the unit acts as a barrier, which in the initial position of the cartridge, prevents the anchor from being advanced distally out of it (see Fig. 8)(Paragraph 0082).
Regarding claim 5, Paz makes obvious the system as discussed above.
Paz further teaches wherein, for each of the cartridges, while the cartridge is in its initial position, the cartridge inhibits sliding of the corresponding anchor distally along the tether and through the proximal opening into the tube (see annotated Fig. 8 below)(As the cartridge is within the magazine and does not access the proximal opening of the tube, the anchor is prevented from sliding distally along the tether of the combination.).
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Regarding claim 6, Paz makes obvious the system as discussed above.
Paz further teaches wherein, for each of the cartridges, the cartridge is configured such that actuation of the cartridge releases the corresponding anchor to be advanced distally along the tether and through the proximal opening into the tube while the cartridge remains coupled to the extracorporeal unit (In Paragraph 0082, Paz teaches that the cartridge is actuatable up into the barrel, and then the fastener is able to be ejected to be advanced distally. Therefore, in the combination with the tether, when the anchor is advanced distally along the tether and through the proximal opening, the cartridge remains indirectly coupled to the extracorporeal unit.).
Regarding claim 7, Paz makes obvious the system as discussed above.
Paz further teaches wherein, for each of the cartridges, the cartridge: comprises a piece that cradles the corresponding anchor (see annotated Fig. 8 below).
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Regarding wherein the cartridge is actuatable by moving the piece proximally, as the piece is able to be moved proximally, the cartridge, which the piece is a part of, is actuatable through moving the piece proximally (see Fig. 8)(Paragraph 0082).
Regarding claim 8, Paz makes obvious the system as discussed above.
Paz further teaches wherein the piece couples the cartridge to the extracorporeal unit (As Paz teaches in Paragraph 0082 that the magazine 63 holds the shells 69, the piece of the shell is indirectly coupled to the extracorporeal unit.).
Regarding claim 9, Paz makes obvious the system as discussed above.
Regarding wherein, for each of the cartridges, the cartridge is actuatable by pulling the corresponding anchor proximally, as the combination of Paz teaches that the anchors are attached to a tether that is threaded through their eyelets, when the cartridge is in the barrel, and before the anchor is actuated distally, when the tether is pulled on, then the anchor and the cartridge would be actuatable (Paragraph 0082).
Regarding claim 10, Paz makes obvious the system as discussed above.
Paz further teaches wherein for each of the cartridges, the cartridge is configured such that, subsequently to the cartridge being actuated, the corresponding anchor is advanceable distally out of the cartridge while the next cartridge remains coupled to the extracorporeal unit (Paragraph 0082)(As the cartridge blocks the next cartridge from moving into the barrel, the next cartridge within the series would remain indirectly coupled to the extracorporeal unit).
Regarding claim 16, Paz makes obvious the system as discussed above.
Regarding wherein the system is configured such that the first anchor is advanceable, with the distal end of the tether, distally into the proximal opening and through the tube toward the tissue while the other anchors remain arranged along the extracorporeal unit, as the combination teaches that the tether is threaded through the eyelets of the anchors (see annotated Fig. 13 below), when the tether is pulled distally, the anchors would move distally and therefore move the first anchor into the proximal opening, and the other anchors would remain arranged along the extracorporeal unit, as they are disposed within cartridges (Paragraph 0082).
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Regarding claim 17, Paz makes obvious the system as discussed above.
Paz further teaches wherein the system is configured such that the first anchor is advanceable, with the distal end of the tether, distally into the proximal opening and through the tube toward the tissue while, for each of the other anchors, the tether remains threaded through the eyelet (see Fig. 13)(Paragraph 0072).
Regarding claim 18, Paz makes obvious the system as discussed above.
Paz further teaches wherein the system is configured such that the first anchor is advanceable, with the distal end of the tether, distally into the proximal opening and through the tube toward the tissue, while a proximal end of the tether remains coupled to the extracorporeal unit (see Fig. 13)(Paragraphs 0070 and 0072).
Regarding claim 19, Paz teaches the system as discussed above.
Paz further teaches the system further comprising an anchor driver (pneumatic valve 77), configured to, for each of the anchors sequentially, engage the head and advance the anchor distally into the proximal opening and through the tube (In Paragraph 0083, Paz teaches that the pneumatic valve releases a compressed gas which engages the head and advances the anchor into the barrel and ejects the anchor through the tube.).
Regarding claim 21, Paz (Paz et al.) teaches a system (1)(Figs. 6- 8) for use with a subject (abstract), comprising:
a tether (filament 10), and
a series of anchors (anchors 50), arranged along the tether (see annotated Fig. 8 below)(Paragraphs 0081 and 0082), each of the anchors comprising:
a tissue- engaging element (53), and
a head (see annotated Fig. 4 below); and
a catheter device (75, 63), comprising:
a tube (75) that has:
a distal opening that is configured to be advanced into the subject (see annotated Fig. 6 below), and
a proximal end that defines a proximal opening (see annotated Fig. 8 below), and
an extracorporeal unit (magazine 63) that is coupled to the proximal end of the tube (Paragraph 0081); and
a series of cartridges (shells 69), arranged along the extracorporeal unit, each of the cartridges:
holding a corresponding anchor of the series of anchors (see annotated Fig. 8 below)(Paragraphs 0081 and 0082).
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Regarding wherein each of the cartridges are coupled to the extracorporeal unit is in an initial position in which the cartridge inhibits sliding of the corresponding anchor distally along the tether and through the proximal opening into the tube, Paz teaches that when the cartridge is within the extracorporeal unit, the anchor is incapable of sliding since it is blocked by the wall of the unit (see annotated Fig. 8 below).
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Regarding each of the cartridges remaining coupled to the extracorporeal unit, and actuatable in a manner that releases the corresponding anchor from the cartridge, Paz teaches that the cartridges are indirectly coupled to the extracorporeal unit, and are able to be actuated to release the anchor (Paragraphs 0081 and 0082).
Paz does not teach in the current embodiment a head defining an eyelet, wherein the tether extends through the eyelet of each of the other anchors to the first anchor.
Paz teaches in a different embodiment, a system (100)(Figs. 5a- 5b and 11-15c) for use with a tissue of a subject (abstract), the system comprising: a catheter device (barrel 102, fasteners 55, filament 109), comprising: a tube (barrel 102) that has: a distal opening that is configured to be transluminally advanced to the tissue (see annotated Fig. 11a below)(Paragraphs 0069 and 0071), and a proximal end (105) and an implant (fasteners 55, filament 109), comprising: a series of anchors, including a first anchor and other anchors (see annotated Fig. 13 below), each of the anchors comprising: a tissue- engaging element (58), and a head that defines an eyelet (see annotated Fig. 5b), and a tether (filament 109) that extends through the eyelet of each of the other anchors to the first anchor (see annotated Fig. 13 below) such that: the first anchor is advanceable, with a distal end of the tether, distally through the tube toward the tissue, and subsequentially, the other anchors are slidable, sequentially over and along the tether, distally into the proximal opening and through the tube toward the first anchor (Paragraphs 0070, 0072, 0073, and 0074).
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Therefore, it would have been obvious to one of ordinary skill in the art to modify the tether as taught by the first embodiment to be the tether that is threaded through the eyelet of each of the anchors as taught by the second embodiment of Paz for the purpose of advancing the anchors along the tube and connecting the anchors within the body (Paz, Paragraphs 0070- 0074 and 0085). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one tether for another because both tethers are disclosed as equivalent structures for advancing anchors along the tube and connecting them within the body (Paz, Paragraphs 0070- 0074 and 0085) and substitution of one for the other would have resulted in the predictable result of connecting the eyelets of the anchors when they are deployed within tissue (Paz, Paragraphs 0070- 0074 and 0085). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
It would have been obvious to one of ordinary skill in the art to modify the anchors as taught by the first embodiment to be the anchors as taught by the second embodiment of Paz since Paz teaches that the anchor of the second embodiment firmly attaches to the tissue (Paragraph 0078) and as Paz teaches that the cartridge (shell 69) is capable of holding the anchor as it can be sized for any anchor (Paragraph 0081). Furthermore, it would have been obvious to one of ordinary skill in the art to substitute one anchor for another because both anchors are disclosed as equivalent structures for attaching tissue in the body (Paz, abstract and Paragraphs 0065, 0066, and 0071) and substitution of one for the other would have resulted in the predictable result of securing tissue within the body (Paz, abstract and Paragraphs 0065, 0066, and 0071). KSR, 550 U.S. 398, 82 USPQ2d 1385 (2007).
Regarding the tether extending through the eyelet of each of the other anchors to the first anchor, as the combination would have the tether extending through the middle of each of the anchors and the cartridges (shell 69) and as Paz teaches that in the first embodiment that there is a reel of filament disposed within the magazine (Paragraph 0085), then it would be obvious that the filament would extend through each anchor and cartridge within the magazine.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz et al. (US 2007/0088390) in view of Zeiner et al. (US 2010/0023024).
Regarding claim 20, Paz makes obvious the system as discussed above.
Paz does not teach wherein the catheter further comprises a port at the proximal opening of the tube, the port comprising a membrane, and the membrane is shaped to define a first aperture through the membrane, a second aperture through the membrane, and a closed slit connecting the first aperture with the second aperture.
Zeiner teaches a system (handle 522 and releasable fastener cartridge 524)(Fig. 55- 57 and 61) with a tube (576) with a proximal opening (see annotated Fig. 61 below) and a port (distal seal 572, ring seal 574) at the proximal opening (see annotated Fig. 61 below) that comprises a duckbill valve (distal seal 572) which defines the first aperture as inlet aperture and second aperture as the outlet and the slit therebetween (Paragraph 0153).
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It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the catheter as taught by Paz to further comprise a port with a membrane as taught by Zeiner, since Zeiner teaches that the membrane prevents “fluids from passing around the exterior of the sheath and out of the abdominal cavity” (Paragraph 0153).
Response to Arguments
Regarding applicant’s arguments, see Page 8, that the fastener 50 would not work with the thread going through the eyelet, this argument has been fully considered and is persuasive. However, a rejection remains utilizing the second embodiment of Paz which features a fastener with an eyelet capable of retaining the filament.
Applicant's arguments filed March 15th, 2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the embodiment of Figs. 6-8 and the embodiment Figs. 11-15 cannot be combined as the features would ruin the hydraulic propulsion of the fastener, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, applicant has not provided evidence to suggest that the combination would not work.
Regarding applicant’s arguments, see Page 9, that the combination of Paz does not make obvious wherein the tether extends through the eyelet of each of the other anchors to the first anchor, this argument has been fully considered but is not persuasive. As discussed above, as the combination would have the tether extending through the middle of each of the anchors and the cartridges (shell 69) and as Paz teaches that in the first embodiment that there is a reel of filament disposed within the magazine (Paragraph 0085), then it would be obvious that the filament would extend through each anchor and cartridge within the magazine. Furthermore, although applicant argues that this would not allow the magazine to function properly, applicant has not provided any evidence that would prove that.
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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/L.R.R./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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