DETAILED ACTION
Notice of 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 .
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.
Claim Rejections - 35 USC § 102
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 and 12 are rejected under 35 U.S.C. 102a1 as being anticipated by Iflah et al. (US Patent Publication 2018/0049875).
Claim 1: Iflah’875 discloses a system comprising:
a delivery catheter (14);
a corkscrew tissue anchor (32) disposed within the delivery catheter (paragraph [0403], [0405]) and having a proximal head portion (62) and a distal pointed portion (clearly shown in Figures 8a, 8b);
a suture (226; paragraph [0397]) coupled to the corkscrew tissue anchor and running proximally within the delivery catheter (Figure 3e; paragraph [0403]); and
a cover (26) covering at least the distal pointed portion of the corkscrew tissue anchor (paragraph [0405]).
Claim 2: Iflah’875 discloses the cover (26) includes one or more radiopaque visual markers (25; paragraph [0412]).
Claim 3: Iflah’875 discloses he one or more radiopaque visual markers (25) comprises first and second radiopaque markers associated with a distal end portion of the cover (Figure 2).
Claim 12: Iflah’875 discloses the cover (26) comprises a woven cloth (paragraphs [0395], [0544]).
Claims 1, 9, 10 and 14 are rejected under 35 U.S.C. 102a1 as being anticipated by Gilmore et al. (US Patent Publication 2015/0119936).
Claim 1: Gilmore’936 discloses a system (Figure 11) comprising:
a delivery catheter (384);
a corkscrew tissue anchor (648b) disposed within the delivery catheter (Figure 11) and having a proximal head portion (652; Figure 12a or 12b) and a distal pointed portion (clearly shown in Figures 12a);
a suture (350; paragraph [0277]) coupled to the corkscrew tissue anchor and running proximally within the delivery catheter; and
a cover (382) covering at least the distal pointed portion of the corkscrew tissue anchor (Figure 11).
Claim 9: Gilmore’936 discloses an elongate driver tool (622) disposed within the delivery catheter, the driver tool having a distal engagement feature (650) configured to engage with the head portion of the tissue anchor (see exploded view in Figure 11; paragraph [0306], [0308]).
Claim 10: Gilmore’936 discloses the distal engagement feature (650)) of the driver tool is engaged with the head portion of the tissue anchor within the delivery catheter (see Figure 11).
Claim 14: Gilmore’936 discloses a second tissue anchor (648a) coupled to a second suture (Figure 3 shows each anchor is connected to a respective tether 50a or 50b; paragraph [0277], [0297] also discloses each anchor can be coupled to a tether) that runs proximally within the delivery catheter (Figure 11), wherein:
the second tissue anchor (648a) is disposed distally of the corkscrew tissue anchor (648b) (Figure 11); and
the second suture passes radially outside of the corkscrew tissue anchor and is prevented from entanglement with the corkscrew tissue anchor by the cover (Figure 11 show the cover has a smooth inner surface which aids in preventing entanglement).
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 3 rejected under 35 U.S.C. 103 as being unpatentable over Gilmore’936, as applied to claim 1, further in view of Rabiner (US Patent Publication 2009/0048629).
Claim 2, 3: Gilmore’936 does not teach the cover includes a radiopaque marker.
Like Gilmore’936, Rabiner’629 teaches a cover (catheter 130; Gilmore’936’s cover 382 is a catheter) for delivering an anchor (100). Rabiner’629 teaches providing the distal end of the cover (130) with a plurality of radiopaque markers to aid in visualizing the distal end of the catheter during delivery of the anchor (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the cover of Gilmore’936 with plurality of radiopaque markers, as taught by Rabiner’629, in order to aid in visualizing the distal end of the catheter during delivery of the anchor (paragraph [0036]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ilfah’875, as applied to claim 1, further in view of Cole et al. (US Patent Publication 2014/0257444).
Claim 4: Iflah’875 discloses the cover (26) includes one or more radiopaque visual markers (25; paragraph [0412]), but does not disclose the markers comprise polymer having a radiopacifier filler of less than 60% density.
It is old and well known to create radiopaque markers by mixing radiopacifiers with polymer. For example, Cole’444 teaches a radiopaque marker (50) that is made of a polymer that is mixed with a radiopacifier material (paragraph [0036)). Further, Cole’44 teaches that modifying the density of the radiopacifier material allows for a change in the level of radiopacity (i.e. light, medium or dark). Specifically, Cole’544 teaches a radiopaque marker having a mixture of polymer and radiopacifier in which the radiopacifier comprises 12.5% of the volume (paragraph [0037]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Iflah’875 such that the radiopaque markers are made with a combination of polymer mixed with a radiopacifier, as taught by Cole’444, because this is a standard technique for creating a radiopaque marker for surgical implants.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gilmore’936, as applied to claim 1, further in view of Rabiner’629 in view of Cole (US Patent Application 2014/0257444).
Claim 4: Gilmore’936 does not teach the cover includes a radiopaque marker.
Like Gilmore’936, Rabiner’629 teaches a cover (catheter 130; Gilmore’936’s cover 382 is a catheter) for delivering an anchor (100). Rabiner’629 teaches providing the distal end of the cover (130) with a plurality of radiopaque markers to aid in visualizing the distal end of the catheter during delivery of the anchor (paragraph [0036]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the cover of Gilmore’936 with plurality of radiopaque markers, as taught by Rabiner’629, in order to aid in visualizing the distal end of the catheter during delivery of the anchor (paragraph [0036]).
Gilmore’936 in view of Rabiner’629 does not disclose the markers comprise polymer having a radiopacifier filler of less than 60% density.
It is old and well known to create radiopaque markers by mixing radiopacifiers with polymer. For example, Cole’444 teaches a radiopaque marker (50) that is made of a polymer that is mixed with a radiopacifier material (paragraph [0036)). Further, Cole’44 teaches that modifying the density of the radiopacifier material allows for a change in the level of radiopacity (i.e. light, medium or dark). Specifically, Cole’544 teaches a radiopaque marker having a mixture of polymer and radiopacifier in which the radiopacifier comprises 12.5% of the volume (paragraph [0037]).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device taught by Gilmore’936 in view of Rabiner’629, such that the radiopaque markers are made with a combination of polymer mixed with a radiopacifier, as taught by Cole’444, because this is a standard technique for creating a radiopaque marker for surgical implants.
Claims 5, 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gilmore’936, as applied to claim 1, further in view of Hindrichs et al. (US Patent Publication 2007/0049942).
Claim 5, 6, 8: Gilmore’936 does not teach a swivel fastener disposed about a shaft of the corkscrew tissue anchor.
Hindrichs’942 teaches a corkscrew tissue anchor (150; Figure 2) that has a proximal head (222) and a swivel fastener (230) disposed about a shaft of the of the corkscrew tissue anchor distal of the head portion (Figure 2). The swivel (230) is rotatable relative to the shaft of the corkscrew anchor (paragraph [0045]) and contains an aperture (240) configured to slidably hold the suture (130) therein.
The swivel (230) is advantageous for allowing a suture (130) to be rotatably coupled to the anchor such that the anchor does not need to be oriented in a particular direction during deployment.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the anchor taught by Gilmore’936 with a swivel, as taught by Hindrichs’942, in order to provide the stated advantages.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Gilmore’936, as applied to claim 1, further in view of Hickman et al. (US Patent Publication 2007/0260216).
Claim 12: Gilmore’936 does not explicitly discloses the cover (382) is a polymer film.
However, it is old and well known to construct catheters (382 is a catheter) of polymer films. For example, Hickman’216 teaches constructing a catheter (2) from a polymer film.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify Gilmore’936 such that the cover (catheter 382) of a polymer film, as taught Hickman’216 because it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gilmore’936 in view of Rosenman (US Patent 5,728,116).
Claim 20: Gilmore’936 discloses system comprising: a delivery catheter (384);
a tissue anchor (648b) disposed within the delivery catheter and having a shaft terminating at a distal pointed tip (clearly shown in Figure 12a).
a suture (350; paragraph [0277]) coupled to the tissue anchor and running proximally within the delivery catheter; and
a cover (382) covering at least the distal pointed tip and the shaft of the tissue anchor (Figure 11).
Gilmore’936 does not teach the tissue anchors has a plurality of barbs.
It is old and well known to add barbs to anchors in order to prevent the anchor from backing out of the tissue. For example, like Gilmore’936, Rosenman’116 teaches a corkscrew tissue anchor (Figures 1-2). Rosenman’116 teaches providing the corkscrew anchors with a plurality of barbs to increase the holding power of the anchor in tissue (column 4, lines 8-10)
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the anchor taught by Gilmore’936 with barbs, as taught by Rosenman’116, in order to prevent the anchor from withdrawing from tissue.
Allowable Subject Matter
Claims 15-19 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: Gilmore’936 teaches the limitations of claim 15 including a delivery sheath (384), a first tissue anchor (648b), a first anti-entanglement cover (382), a first suture (350; paragraph [0277]), a second tissue anchor (648a), a second suture (50a or 50b; pragraphs [0277], [0297]). However, Gilmore’936 does not disclose the second suture passes radially outside of the first cover.
Claims 7, 11 and 13 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.
Conclusion
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Lindsey Bachman
/L.B./Examiner, Art Unit 3771 18 February 2026
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771