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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/27/2021 has been entered.
Response to Amendment
Applicant’s amendment to the Claims have overcome the objection set forth in the Final Office Action mailed on 07/01/2024.
The claim amendments filed on 07/01/2024 have been entered. Claims 19, 104-105, and 108-123 remain pending in the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
The term “connector” is not provided in the specification or the drawings, therefore, the “connector” is not identified in the descriptive portion of the specification by reference to the drawing, designating the part or parts therein to which the term applies.
The terms “first longitudinal edge” and “second longitudinal edge” in claims 109 and 120 are not provided in the specification. The examiner is not able to ascertain what the first and second longitudinal edge is referring to in the applicant’s invention.
The term “pair of slots” in claims 110, 111, 121, and 122 is not provided in the specification. The examiner is not able to ascertain what “pair of slots” is referring to.
The term “channel” in claims 110 and 123 in reference to the connector is not provided in the specification. The examiner is not able to ascertain what “channel” is being referred to.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the
Connector of
First longitudinal edge of claims 109 and 120
Second longitudinal edge of claims 109 and 120
Pair of slots in claims 110, 111, 121, and 122
Body of connector in claims 110, 112, 121, and 123
Channel of connector in claims 110 and 123
must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant's arguments filed 07/01/2024 have been fully considered but they are not persuasive.
In response to applicant’s argument on page 2, which states that Solem ‘943 fails to disclose, among other features, an annular anchor with first and second arms that are arranged diametrically opposed to one another, and symmetrically aligned about the central axis of the annular anchor, the examiner respectfully disagrees. The definition of diametrically is “completely opposed: being at opposite extremes”. The arms which are annotated in Figure 12B are completely opposed to each other in terms of location, and are symmetric. The arms may be in a “flowered” configuration, and still have arms that are diametrically opposed and symmetric to each other.
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.
(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.
Claims 19, 104-105, 108-109, and 114 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Solem et al (US 2007/0270943 A1).
Regarding claim 19, Solem discloses an annular anchor (Figure 12B, annular anchor annotated below) comprising:
a connector (Figures 12A-B, coupling member 140 with generally tubular projection 154 constitutes the connector (annotated in Figure 12A below)) oriented at a central axis of the annular anchor (Figure 12B, central axis annotated below, the connector is oriented at the central axis of the annular anchor);
an anchor pin (Figures 12A-B, item 132 (anchor pin annotated in Figure 12A below)) comprising a first arm (Figure 12A, first arm annotated below) and a second arm (Figure 12A, second arm annotated below),
the first and second arms projecting outwardly from the connector (Figures 12A-B depicts first and second arms projecting outwardly from the connector (140,154)),
wherein the first arm and the second arm are arranged diametrically opposed to one another (Figure 12B, first and second arm are depicted diametrically opposed to one another where the definition of diametrically is “completely opposed”, the first and second arm are completely opposed to each other being on opposite sides of the center line),
and symmetrically aligned about the central axis of the annular anchor (Figure 12B which shows a cross-section of Figure 12A depicts the first and second arm symmetrically aligned about the central axis of the annular anchor).
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Regarding claim 104, Solem discloses wherein the first and second arms each extends from a first end (first end annotated in Figure 12B below) secured to the connector (Figure 12B, first end secured to the connector through the connection of the anchor pin 132 to the connector 154) along a first region (first region annotated in Figure 12B below) to a curved intermediate region (curved intermediate region annotated in Figure 12B below), and therefrom extends along a second region (second region annotated in Figure 12B below) towards a second end (second end in Figure 12B below).
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Regarding claim 105, Solem discloses wherein the first and second arm each comprises a substantially U-shaped cross-section (Figure 12B above depicts the first and second arm having a substantially U-shaped cross-section).
Regarding claim 108, Solem discloses wherein a width of the second region of each of the first and second arms gradually decreases to terminate at the second end of the respective first and second arms (Figures 12A-B depicts wherein the width of the second region of each of the first and second arms gradually decreases to terminate at the point of the second end).
Regarding claim 109, Solem discloses wherein each of the first and second arms comprises a first longitudinal edge (first longitudinal edge annotated in Figure 12B below) and an opposed second longitudinal edge (second longitudinal edge annotated in Figure 12B below), wherein the first longitudinal edge curves radially outwardly to an intermediate point (Figure 12B depicts the first longitudinal edge curved radially outward to an intermediate point), and therefrom curves radially outwardly to the second longitudinal edge (Figure 12B depicts the first and second arms further curving radially outwardly from the intermediate point to the second longitudinal edge).
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Regarding claim 114, Solem discloses wherein the first arm, the second arm and the connector are integrally formed (Figure 12B depicts the first arm, second arm, and the connector (140, 154) integrally formed, where the definition of integral is “formed as a unit with another part”).
Claims 115-120, and 123 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hiorth et al (US 2022/0015906 A1).
Regarding claim 115, Hiorth discloses an annular anchor (Figure 10, item 10 “leaflet anchor”) comprising:
a connector (Figure 10, connector annotated below) oriented at a central axis of the annular anchor (Figure 10, central axis of annular anchor annotated below);
and an annular pin (Figure 10, annular pin annotated below) consisting of a first arm and a second arm (Figure 10, first and second arm annotated below),
the first and second arms projecting outwardly from the connector (the first and second arms are shown projected outwardly from the connection in Figure 10 below),
wherein the first arm and the second arm are arranged diametrically opposed to one another (Figure 10, the first and second arm are shown diametrically opposed to one another),
and symmetrically aligned about the central axis of the annular anchor (the first and second arms are symmetrically aligned about the central axis as seen in Figure 10).
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Regarding claim 116, Hiorth discloses wherein the first arm, the second arm, and the connector are integrally formed (Figure 10 above depicts the first arm, second arm, and connector as integrally formed).
Regarding claim 117, Hiorth discloses wherein the first and second arms (Figure 10) each extends from a first end (Figure 10, annotated first end below) secured to the connector along a first region (first end secured to connector at first region) to a curved intermediate region (Figure 10, curved intermediate region annotated below), and therefrom extends along a second region towards a second end (Figure 10, second end extends from second region).
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Regarding claim 118, Hiorth discloses wherein the first and second arm each comprises a substantially U-shaped cross-section (Figure 10, first and second arm comprises a substantially U-shaped cross-section).
Regarding claim 119, Hiorth discloses wherein a width of the second region of each of the first and second arms gradually decreases to terminate at the second end of the respective first and second arms (Figures 10 depicts wherein the width of the second region of each of the first and second arms gradually decreases to terminate at the point of the second end).
Regarding claim 120, Hiorth discloses wherein each of the first and second arms comprises a first longitudinal edge (first longitudinal edge annotated in Figure 10 below) and an opposed second longitudinal edge edge (second longitudinal edge annotated in Figure 10 below), wherein the first longitudinal edge curves radially outwardly to an intermediate point (Figure 10 depicts the first longitudinal edge curved radially outward to an intermediate point), and therefrom curves radially outwardly to the second longitudinal edge (Figure 10 depicts the first and second arms further curving radially outwardly from the intermediate point to the second longitudinal edge).
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Regarding claim 123, Hiorth discloses wherein a tether (Figures 12 and 15, item 14) is connected within the channel of the body of the connector (see Hiorth, paragraph 0303 discloses wherein the tether is attached to the connector, which would occur through a channel in the body of the connector) , arranged to extend opposite to the first and second arms (Figure 15, the tether 14 extends opposite the first and second arms).
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 110-113 are rejected under 35 U.S.C. 103 as being unpatentable over Solem et al (US 2007/0270943 A1) in view of Solem (US 2008/0195126 A1).
Regarding claim 110, Solem ‘943 discloses a channel defined within the body (see Figure 12B, a channel (annotated below) can be seen through the body of the connector 140, 154) which extends along a longitudinal axis of the body (Figure 12B, channel extends along longitudinal axis of body).
However, Solem ‘943 does not disclose wherein the connector comprises a body having a pair of slots defined on a surface thereof.
Solem ‘126 discloses an annular anchor and teaches wherein the connector (see Solem ‘126, Figure 4A, item 100 “anchor portion”) comprises a body having a pair of slots defined on a surface thereof (see Solem ‘126, Figure 4A, item 114 “holes”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Solem ‘943 to include a pair of slots defined on a surface of the body as taught by Solem ‘126 for the purpose of adding strength to the fixation and promoting healing and tissue growth (see Solem ‘126, paragraph 0057).
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Regarding claim 111, as set forth supra, the combination discloses wherein the pair of slots are oriented diametrically opposed to one another (see Solem ‘126, Figure 4A depicts a multitude of holes 114 that have a mate which is diametrically opposed).
Regarding claim 112, as set forth supra, the combination discloses wherein the body comprises a circular cross-sectional shape (see Solem ‘943, the body of the connector (140,154) has a circular cross-sectional shape).
Regarding claim 113, as set forth supra, the combination discloses wherein a tether (see Figure 12B of Solem, ‘943, item 118, tether annotated above), is connected within the channel of the of the connector body (See Solem ‘943, Figure 12B above shows tether 118 connected in the channel of the body of the connector), arranged to extend opposite to the first and second arms (tether 118 extends opposite to first and second arms).
Claims 121 and 122 are rejected under 35 U.S.C. 103 as being unpatentable over Hiorth et al (US 2022/0015906 A1) in view of Solem (US 2008/0195126 A1).
Regarding claim 121, Hiorth discloses a channel defined within the body which extends along a longitudinal axis of the body (see Hiorth, Figures 8 and 9 depict a cross-section of the body of the connector with a channel along the longitudinal axis of the body) .
However, Hiorth does not disclose wherein the connector comprises a body having a pair of slots defined on a surface thereof.
Solem ‘126 discloses an annular anchor and teaches wherein the connector (see Solem ‘126, Figure 4A, item 100 “anchor portion”) comprises a body having a pair of slots defined on a surface thereof (see Solem ‘126, Figure 4A, item 114 “holes”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the connector of Hiorth to include a pair of slots defined on a surface of the body as taught by Solem ‘126 for the purpose of adding strength to the fixation and promoting healing and tissue growth (see Solem ‘126, paragraph 0057).
Regarding claim 122, as set forth supra, the combination discloses wherein the pair of slots are oriented diametrically opposed to one another (see Solem ‘126, Figure 4A depicts a multitude of holes 114 that have a mate which is diametrically opposed).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA LYNEE ZIMMERMAN whose telephone number is (313)446-4864. The examiner can normally be reached Mon. 8:30 AM-6:30 PM, Tues. - Fri. 8:30-4:00 PM.
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, Melanie Tyson can be reached on 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA LYNEE ZIMMERMAN/Examiner, Art Unit 3774
/BRIAN A DUKERT/Primary Examiner, Art Unit 3774
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