DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-11) and Species A (Figures 5A-6B) in the reply filed on 08/12/26 is acknowledged.
Claims 4, 6, 7, 9, 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/12/26.
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 1-3, 5, 8, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gertner et al., hereinafter “Gertner” (U.S. Pub. No. 2005/0216040).
Regarding claim 1, Gertner discloses a tether protection device, comprising:
an inflatable member 65 (Figure 2G; [0086]) configured to be positioned over an opening in a target tissue, the inflatable member comprising a central portion defining an opening 66 extending through the inflatable member, the opening of the inflatable member being configured to allow for a plurality of tethers extending from the opening in the target tissue to be disposed at least partially therein (similar to how opening 44 of device allows connector 12 to extend through in Figures 2C-2D, the opening 66 is capable of allowing a plurality of tethers to be disposed at least partially therein); and
a fluid port 63 ([0087]-[0089]) extending through a wall portion of the inflatable member, the inflatable member being configured to be inflated via the fluid port to:
an initial inflation state (position in between deflated configuration in Figure 2I and fully inflated configuration in Figure 2H, when the inflatable member is first starting to inflate and teeth 68 are not gripping the connector 12 or plurality of tethers) in which the plurality of tethers is allowed to move freely within the opening of the inflatable member, and
a first inflation state (position in Figure 2H or position right before being fully inflated in Figure 2H when teeth 68 initially start gripping the connector 12 or plurality of tethers) in which at least a portion of the central portion is collapsed around and in contact with the plurality of tethers (Id.).
Regarding claim 2, Gertner discloses an externally oriented surface of the central portion comprises a texture ([0086]; protrusions 69, and gripping elements 67 can have teeth 68 angled toward top external surface).
Regarding claim 3, Gertner discloses the texture comprises at least one
of a plurality of bumps and a plurality of ridges 68 (Id.).
Regarding claim 5, Gertner discloses a circumferential portion of the inflatable member 65 forms a circular shape (Figure 2G).
Regarding claim 8, Gertner discloses the opening 66 of the inflatable member comprises 65 a circular shape while the inflatable member is in the first inflation
state (Figure 2H).
Regarding claim 10, Gertner discloses the inflatable member 65 is configured
to be maintained in a second inflation state while a pair of tether tails of the plurality of
tethers is tied together ("configured to be maintained in a second inflation state while a pair of tether tails of the plurality of tethers is tied together" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner; the Office submits that the device of Gertner meets the structural limitations of the claim, and is capable of being further inflated from said first inflation state [as discussed above] such that the teeth 68 further grips connector 12 or the plurality of tethers extending therethrough which have tails that are tied together), the second inflation state being more pressurized than the first inflation state (Id.).
Claims 1, 5, 8, 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huddleston et al., hereinafter “Huddleston” (U.S. Pub. No. 2021/0236287).
Regarding claim 1, Huddleston discloses a tether protection device, comprising:
an inflatable member 491 (Figures 4A-4B; [0056]-[0059]) configured to be positioned over an opening in a target tissue, the inflatable member comprising a central portion defining an opening 492 extending through the inflatable member, the opening of the inflatable member being configured to allow for a plurality of tethers extending from the opening in the target tissue to be disposed at least partially therein (similar to how opening 492 of device allows tether 436 to extend through, the opening 492 is capable of allowing a plurality of tethers to be disposed at least partially therein); and
a fluid port 486 (Id.) extending through a wall portion of the inflatable member, the inflatable member being configured to be inflated via the fluid port to:
an initial inflation state (position in between deflated configuration in Figure 4A and fully inflated configuration in Figure 4B, when the inflatable member is first starting to inflate and pins 488 are not gripping the tether 436 or plurality of tethers) in which the plurality of tethers is allowed to move freely within the opening of the inflatable member, and
a first inflation state (position in Figure 4B or position right before being fully inflated in Figure 4B when pins 488 initially start gripping the tether 436 or plurality of tethers) in which at least a portion of the central portion is collapsed around and in contact with the plurality of tethers (Id.).
Regarding claim 5, Huddleston discloses a circumferential portion of the inflatable member 491 forms a circular shape (Figures 4A-4B).
Regarding claim 8, Huddleston discloses the opening 492 of the inflatable member 491 comprises a circular shape while the inflatable member is in the first inflation state (Figure 4B).
Regarding claim 10, Huddleston discloses the inflatable member 491 is configured to be maintained in a second inflation state while a pair of tether tails of the plurality of tethers is tied together ("configured to be maintained in a second inflation state while a pair of tether tails of the plurality of tethers is tied together" constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner; the Office submits that the device of Huddleston meets the structural limitations of the claim, and is capable of being further inflated from said first inflation state [as discussed above] such that the pins 48 further grips or pierces tether 436 or the plurality of tethers extending therethrough which have tails that are tied together), the second inflation state being more pressurized than the first inflation state (Id.).
Claim Rejections - 35 USC § 103
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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Huddleston (U.S. Pub. No. 2021/0236287) in view of Gertner (U.S. Pub. No. 2005/0216040).
Regarding claims 2-3, Huddleston discloses the claimed invention, as discussed above, except for an externally oriented surface of the central portion comprises a texture, wherein the texture comprises at least one of a plurality of bumps and a plurality of ridges. Huddleston instead teaches fastening devices or pins 488 that can be used to pierce a tether or a plurality of tethers ([0057]-[0059]).
In the same field of art, namely tether protection devices, Gertner teaches an externally oriented surface of a central portion of inflatable member 65 comprises a texture ([0086]; protrusions 69, and gripping elements 67 can have teeth 68 angled toward top external surface), wherein the texture comprises at least one of a plurality of bumps and a plurality of ridges 68 (Id.).
It would have been obvious to one of ordinary skill before the effective filing date to modify Huddleston with a texture as claimed, as taught by Gertner, since doing so would be substitution of one known fastening device for another, which would yield predictable results, namely facilitating securing the position of a tether within the device. See MPEP 2143.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANE D YABUT whose telephone number is (571)272-6831. The examiner can normally be reached M-F 9am-5pm.
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/DIANE D YABUT/Primary Examiner, Art Unit 3771
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