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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-11) with a species election of Species 1-2 (Claims 8-11) and Species 2-1 (Claim 13) in the reply filed on 10/28/2025 is acknowledged.
Claims 6-7, 12-17, 21-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected “Catheter device having an anchor deployment mechanism and an anchor”(Claims 12-17), “A first method of manufacturing an anchor”(Claim 21), “A second method of manufacturing an anchor”(Claim 22), “A method of use of an anchor” (Claim 23) and a non-elected species of plugging device (Claims 6-7), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/2/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Paz (US 2009/0182352 A1).
Regarding claim 1, Paz discloses
An anchor configuration for implantation in body tissue (see Fig. 7), the anchor configuration comprising:
an anchor comprising a number of hooks (barbs 84, see Fig. 10) for engagement with the body tissue (see Para. [0111]) and having a folded (see Fig. 9) and unfolded position (see Fig. 7);
wherein the anchor is made of an elastic material such that it can be elastically deformed into the folded position by application of a constraining force (see Para. [0021] mentioning wherein the device may be formed from nitinol), and will return to the unfolded position when no constraining force is applied (see Para. [0021] and Figs. 7 and 9 showing a transition between a deployed, expanded configuration and an undeployed, constrained configuration); and
a plugging device for enhancing contact with the body tissue (baseplate 82, see Fig. 10);
wherein the plugging device is for combining with one or more parts of the anchor to provide the enhanced contact (see Figs. 9-10 and Para. [0110]); and
wherein at least one of the hooks is encircled by the plugging device (see Fig. 9 showing widened portions (89) of the barbs are disposed within and encircled by the baseplate; see also Para. [0110]).
Regarding claim 2, Paz discloses the invention of claim 1, Paz further discloses wherein the plugging device is configured to seal an entry site between the hooks and the body tissue when the anchor is implanted in the body tissue (the baseplate is adapted to seal an entry site between the barbs and the body tissue; see Fig. 10; see also Fig. 2 and Para. [0101]-[0102] for functionality reference in which baseplate (12) seals the opening in tissue made during insertion of the hooks into said tissue).
Regarding claim 3, Paz discloses the invention of claim 1, Paz further discloses wherein the anchor comprises an anchor body (crown 81, see Fig. 10), wherein the hooks extend from a base of the anchor body (see Fig. 10).
Regarding claim 4, Paz discloses the invention of claim 3 Paz further discloses wherein the anchor body is configured to compress the plugging device against the body tissue when the hooks are in the unfolded position and the anchor is implanted in the body tissue (see Figs. 9-10 and Para. [0110] mentioning wherein movement of the baseplate and crown closer to one-another compresses the barbs into a deployed configuration).
Regarding claim 5, Paz discloses the invention claim 1, Paz further discloses wherein a portion of the plugging device encircling the at least one hook is configured to provide a first sealing surface around a respective entry site of the at least one hook (see Figs. 2 and 10; see also Para. [0101]-[0102] and [0110]), and wherein the plugging device is configured to provide a second sealing surface capturing all of the entry sites of all of the hooks (see Figs. 2 and 10).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-4 and 8-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Conklin (US 2019/0224009 A1) in view of Paz (US 2009/0182352 A1).
Regarding claim 1, Conklin teaches:
An anchor configuration for implantation in body tissue (see Fig. 4), the anchor configuration comprising:
an anchor comprising a number of hooks (arms 116, see Fig. 4) for engagement with the body tissue (see Fig. 6) and having a folded (see Para. [0039] mentioning wherein the arms may be flexed radially-inward towards the hub (114)) and unfolded position (see Fig. 4 and Para. [0039]);
a plugging device for enhancing contact with the body tissue (suture shown in Fig. 6; see also Para. [0042]);
wherein the plugging device is for combining with one or more parts of the anchor to provide the enhanced contact (see Fig. 6 showing wherein the suture is threaded through the valve tissue; see also Para. [0038]); and
wherein at least one of the hooks is encircled by the plugging device (see Fig. 6 and Para. [0042] mentioning wherein the suture is knotted through openings within the arms).
However, while Conklin discloses wherein the anchor is configured to radially expand and contract by allow the arms to move either away from or towards the central hub (see Para. [0041]), Conklin does not expressly disclose wherein the anchor is made of an elastic material such that it can be elastically deformed into the folded position by application of a constraining force, and will return to the unfolded position when no constraining force is applied.
In the same field of endeavor, namely tissue anchor devices, Paz teaches:
An anchor configuration for implantation in body tissue (see Fig. 7), the anchor configuration comprising:
an anchor comprising a number of hooks (barbs 84, see Fig. 10) for engagement with the body tissue (see Para. [0111]) and having a folded (see Fig. 9) and unfolded position (see Fig. 7);
wherein the anchor is made of an elastic material such that it can be elastically deformed into the folded position by application of a constraining force (see Para. [0021] mentioning wherein the device may be formed from nitinol), and will return to the unfolded position when no constraining force is applied (see Para. [0021] and Figs. 7 and 9 showing a transition between a deployed, expanded configuration and an undeployed, constrained configuration).
It would have been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, to have modified at lest a portion of the anchor of Conklin to formed from nitinol as disclosed by Paz to allow for elastic deformation into the folded position while maintaining the ability to return to its normal unfolded position upon release of a compressive force (i.e., during navigation through tortuous anatomy or during movement of the valve within which the device of Conklin is to be implanted within) since it has been held that selection of a known material for a specific intended purpose is obvious to one of ordinary skill in the art (see In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960)).
Regarding claim 2, the combination of Conklin and Paz discloses the invention of claim 1, Conklin further discloses wherein the plugging device is configured to seal an entry site between the hooks and body tissue when the anchor is implanted in body tissue (see Fig. 6 and Para. [0038] and [0042] mentioning wherein the suture is utilized to seal the valve tissue to the arms of the anchor device; thereby sealing the body tissue to the arms of the anchor device).
Regarding claim 3, the combination of Conklin and Paz discloses the invention of claim 1, Conklin further discloses wherein the anchor comprises an anchor body (anchor body 104, see Figs. 3 and 6), wherein the hooks extend from the base of the anchor body (see Fig. 6).
Regarding claim 4, the combination of Conklin and Paz discloses the invention of claim 4, Conklin further discloses wherein the anchor body is configured to compress the plugging device against the body tissue when the hooks are in the unfolded position and the anchor is implanted in the body tissue (see Figs. 6 and Para. [0038] and [0042] mentioning wherein the sutures are secured through openings within the insert (104) during coupling to the valve tissue; the insert serves as an anchor to compress the suture against the tissue when the implant is sufficiently tensioned against said tissue).
Regarding claim 8, the combination of Conklin and Paz discloses the invention of claim 1, Conklin further discloses wherein the plugging device is a line (suture shown in Fig. 6), the line in combination with the anchor (see Fig. 6); the line is joined to the anchor by a knotting configuration (see Para. [0042] and Fig. 6) comprising a plurality of loops around the anchor (see Fig. 6); and the at least one hook is encircled by at least one loop of the plurality of loops (see Fig. 6 showing wherein the left-most arm is encircled by the suture forming a knot therein).
Regarding claim 9, the combination of Conklin and Paz discloses the invention of claim 8, Conklin further discloses wherein the knotting configuration comprises at least two knots (see Fig. 6 showing a plurality of knots).
Regarding claim 10, the combination of Conklin and Paz discloses the invention of claim 8, Conklin further discloses wherein the anchor comprises an anchor body (insert 104, see Fig. 6), wherein the hooks extend from a base of the anchor body (see Fig. 6); and the anchor body is a tubular body (see Figs. 4 and 6), and wherein at least part of the knotting configuration is located within the tubular body (see Fig. 6 showing the suture forming knots within the insert).
Regarding claim 11, the combination of Conklin and Paz discloses the invention of claim 8, Conklin further discloses wherein the anchor comprises an anchor body (insert 104, see Fig. 6), wherein the hooks extend from a base of the anchor body (see Fig. 6); and the anchor body comprises at least two threading holes (see Examiner’s Diagram of Fig. 6 below showing two threading holes within the body of the insert), wherein the threading holes accommodate at least part of the knotting configuration (see Examiner’s Diagram of Fig. 6 below showing wherein the two labeled threading holes receive the suture therethrough).
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Examiner’s Diagram of Fig. 6
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2004/0003819 A1 to St. Goar, US 10660633 B2 to Vyhmeister, US 2005/0234512 A1 to Nakao, US 2019/0343634 A1 to Garvin, US 2004/0078054 A1 to Biggs, US 2019/0343633 A1 to Garvin, US 2016/0128682 A1 to Konrath, US 2023/0320717 to Palese, US 2019/0247039 A1 to Gregoire, US 2019/0015091 A1 to Guo, US 2016/0038267 A1 to Allen, US 2024/0108328 A1 to Stone, US 2016/0199115 A1 to Anderson, US 2010/0292733 A1 to Hendricksen, US 2025/0120802 A1 to Zens, US 2010/0198258 A1 to Heaven, US 2012/0046747 A1 to Justin, US 2004/0002734 A1 to Fallin, US 2012/0059416 A1 to Justin, US 2016/0157851 A1 to Spenciner, US 2023/0233200 A1 to Kubiak, US 2003/0144696 A1 to Sinnott, US
2012/0029562 A1 to Trenhaile, US 6146406 A to Shluzas, US 2009/0287246 A1 to Caludwell, US 2006/0293710 A1 to Foerster, US 11375995 B1 to Tran, US 11678872 B2 to Gammie, US 5549633 A to Evans and US 8226682 B2 to Maruyama all disclose anchor devices comprising a suture thread wrapped or looped around at least a portion of the anchor device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771