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 .
Claim Objections
Claim 33 is objected to because of the following informalities: The claim reads “wherein the proximal expandable portion comprise elongated ribs.” “Comprise” should be replaced with “comprises.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25 – 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 25 recites “a proximal reversibly expandable portion being reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS.”
It is unclear what the “proximal reversibly expandable portion” is referring to. Is it a proximal portion of the annuloplasty device as a whole? Or is it a proximal portion of the displacement unit. It is noted that the claim later recites that the “displacement unit comprises a distal anchoring portion.” It is recommended to state that the displacement unit also comprises the proximal reversibly expandable portion.
Furthermore, It is unclear what is meant by “reversibly foldable.” Does it mean the proximal reversibly expandable portion can be expanded/unfolded after being compressed/folded? Or does it mean the proximal reversibly expandable portion can be folded in one direction and a reversible direction? It is noted that the “proximal reversibly expandable portion” appears to have support in the spec teaching that the proximal portion may be expanded and then collapsed for retrieval.
Dependent claims 26 – 35 do not cure the deficiencies of independent claim 25.
Claim 36 recites “inserting a flexible and removable elongate displacement unit… positioning a proximal reversibly expandable portion… anchoring a distal anchoring portion inside the CS.” It is unclear what the proximal and distal portions are a part of. It is recommended to state that the displacement unit comprises a proximal portion and a distal portion.
Dependent claims 37 – 43 do not cure the deficiencies of independent claim 36.
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.
Claim(s) 25 – 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keränen et al. (US PGPUB 2016/0095705).
Regarding claim 25, Keränen discloses an annuloplasty device (e.g. 100) for treating a defective mitral valve having an annulus (e.g. ¶ 41), comprising:
a removable and flexible elongate displacement unit (e.g. 101) for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state (e.g. ¶ 41),
a proximal reversibly expandable portion (e.g. 102) being reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS (e.g. ¶ 41),
wherein the displacement unit comprises a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape when inserted in the CS (e.g. ¶ 41; Figs. 3a-b),
a stent (e.g. 105) arranged around the displacement unit and being movable relative the displacement unit along the longitudinal direction for insertion into the CS (e.g. ¶ 42), and
wherein the stent (e.g. 105) is releasably connected to a delivery device and arranged radially between the displacement unit and the proximal expandable portion in a radial direction (R), the radial direction (R) being perpendicular to the longitudinal direction, wherein the proximal expandable portion is connected to a sheath and is configured to be expanded in the radial direction (R) by pushing a proximal portion of the sheath towards the distal anchoring portion (e.g. ¶ 45 – 46),
the annuloplasty device comprising a catheter (e.g. 109) to enclose the stent and position the stent relative the displacement unit in the longitudinal direction, wherein the stent is ejectable from, and retrievable into, the catheter by the delivery device (e.g. ¶ 47),
wherein the catheter is movable over the displacement unit and inside said sheath in the longitudinal direction, in said activated state (e.g. ¶ 49).
Regarding claim 26, Keränen discloses the stent is reversibly expandable in the radial direction (R) in said activated state (e.g. ¶ 50).
Regarding claim 27, Keränen discloses the stent comprises retention units to anchor the stent in the CS (e.g. ¶ 51).
Regarding claim 28, Keränen discloses the retention units are arranged on a defined surface section of the stent adapted to be arranged towards the annulus when the stent is in the CS (e.g. ¶ 52).
Regarding claim 29, Keränen discloses a plurality of retention units are arranged around a circumference of the stent (e.g. ¶ 53).
Regarding claim 30, Keränen discloses the retention units are resiliently moveable from a retracted state to an expanded state, whereby the retention units are flexible to bend from the expanded state to the retracted state when arranged inside the catheter, and expand from the retracted state to the expanded state when released from the catheter (e.g. ¶ 55).
Regarding claim 31, Keränen discloses the retention units are aligned essentially flush with an outer diameter of the stent in the retracted state (e.g. ¶ 56).
Regarding claim 32, Keränen discloses a distance (L) between the proximal expandable portion and the distal anchoring portion in the longitudinal direction decreases to a reduced distance (L') when the displacement unit is transferred from the delivery state to the activated state (e.g. ¶ 41).
Regarding claim 33, Keränen discloses the proximal expandable portion comprise elongated ribs formed in a sheath by elongated cuts in the sheath, extending in the longitudinal direction, the ribs being foldable to expand in the radial direction (R) (e.g. ¶ 62).
Regarding claim 34, Keränen discloses the distal anchoring portion comprises an inflatable unit being expandable in the radial direction (R) (e.g. ¶ 58).
Regarding claim 35, Keränen discloses a guide wire arranged to extend inside a lumen of the displacement unit and to exit the lumen at a distal opening of the displacement unit (e.g. ¶ 64).
Regarding claim 36, Keränen discloses a method (e.g. 400) for treating a defective mitral valve having an annulus (e.g. ¶ 65), said method comprising:
Inserting (e.g. 401) a flexible and removable elongate displacement unit, having a longitudinal direction, in a delivery state into a coronary sinus (CS) adjacent said valve (e.g. ¶ 65),
Positioning (e.g. 402) a proximal reversibly expandable portion against a tissue wall at the entrance of said CS, wherein the proximal expandable portion is connected to a sheath (e.g. ¶ 65),
Anchoring (e.g. 403) a distal anchoring portion inside the CS (e.g. ¶ 65),
Expanding the proximal reversibly expandable portion in a radial direction (R),perpendicular to the longitudinal direction, by pushing a proximal portion of the sheath towards the distal anchoring portion (e.g. ¶ 68),
Activating (e.g. 404) the displacement unit in an activated state whereby the distal anchoring portion is moved in the longitudinal direction of the displacement unit to reduce a distance (L) between the distal anchoring portion and the proximal expandable portion such that the shape of the annulus is modified to a modified shape (e.g. ¶ 65),
Advancing (e.g. 405) a stent through the proximal expandable portion and over the displacement unit into the CS (e.g. ¶ 65),
anchoring (e.g. 406) the stent in the CS to retain the modified shape of the annulus (e.g. ¶ 65),
withdrawing (e.g. 407) the displacement unit through the stent to remove the displacement unit after temporary activation in the activated state (e.g. ¶ 65).
Regarding claim 37, Keränen discloses the distal anchoring portion comprises an inflatable unit and anchoring the distal anchoring portion comprises inflating the inflatable unit in the coronary sinus, and/or in the great cardiac vein and/or, and/or in the anterior interventricular branch or vein, and/or in the posterior vein, and/or in the posterior ventricular vein of the heart (e.g. ¶ 67).
Regarding claim 38, Keränen discloses withdrawing a catheter enclosing the stent and expanding the stent in a radial direction (R) being perpendicular to the longitudinal direction (e.g. ¶ 69).
Regarding claim 39, Keränen discloses the catheter is movable through the proximal expandable portion and over the displacement unit in the longitudinal direction (e.g. ¶ 70).
Regarding claim 40, Keränen discloses anchoring retention units of the stent into the CS to retain the modified shape of the annulus when the displacement unit is withdrawn (e.g. ¶ 71).
Regarding claim 41, Keränen discloses anchoring the retention units in a tissue wall of the CS in the direction of the annulus (e.g. ¶ 72).
Regarding claim 42, Keränen discloses advancing the catheter over the stent to disengage the stent from the CS for repositioning or removal of the stent from the CS (e.g. ¶ 73).
Regarding claim 43, Keränen discloses releasing the stent from a delivery device movably arranged inside the catheter (e.g. ¶ 74).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796