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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 22-25 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 22, the specification and the drawings do not disclose wherein the projection at the lumen as a width (w1) in the radial direction smaller than a width (w2) of the proximal tip in the radial direction and wherein the lumen extends along an axial direction of the first end. The specification discloses the projection at the lumen as a width (w1) in the radial direction smaller than a width (w2) of the proximal tip in the radial direction on page 11 line 23 – page 12 line 2 and, in a separate embodiment, the lumen extends along an axial direction of the first end on page 10 lines 12-23. However, there is no description of how these two embodiments would work together. The specification and the drawings do not describe or show a projection at the lumen is smaller in the radial direction than the proximal tip in the radial direction in combination with the lumen extending along an axial direction of the first end. Dependent claims 23-25 are likewise rejected.
Regarding claim 23, the specification and the drawings do not disclose wherein the projection at the lumen as a width (w1) in the radial direction smaller than a width (w2) of the proximal tip in the radial direction and wherein the lumen is coaxially aligned with the first end along the axial direction. The specification discloses the projection at the lumen as a width (w1) in the radial direction smaller than a width (w2) of the proximal tip in the radial direction on page 11 line 23 – page 12 line 2 and, in a separate embodiment, the lumen may be coaxially aligned with he first end along the axial direction on page 10 lines 24-28. However, there is no description of how these two embodiments would work together. The specification and the drawings do not describe or show a projection at the lumen is smaller in the radial direction than the proximal tip in the radial direction in combination with the lumen being coaxially aligned with the first end along the axial direction.
Regarding claim 24, the specification and the drawings do not disclose wherein the projection at the lumen as a width (w1) in the radial direction smaller than a width (w2) of the proximal tip in the radial direction and wherein the lumen comprises a drilled opening in the proximal tip. The specification discloses the projection at the lumen as a width (w1) in the radial direction smaller than a width (w2) of the proximal tip in the radial direction on page 11 line 23 – page 12 line 2 and, in a separate embodiment, the lumen may comprise a drilled opening in the proximal tip on page 10 line 29 – page 11 line 5. However, there is no description of how these two embodiments would work together. The specification and the drawings do not describe or show a projection at the lumen is smaller in the radial direction than the proximal tip in the radial direction in combination with the lumen comprising a drilled opening in the proximal tip. Dependent claim 25 is likewise rejection.
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.
Claim 24-25 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 24 recites “wherein the lumen comprises a drilled opening in the proximal tip” in lines 1-2. From claim 16 lines 8-9, it is understood the lumen is through a projection which extends from the proximal tip. The lumen is not in the proximal tip. It is unclear if the lumen of claim 24 is the same lumen in the projection of claim 16 or a separate and additional lumen. Dependent claim 25 is likewise rejected.
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.
The factual inquiries 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.
Claim(s) 16-18, 25 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 2018/0177594 A1) in view of Cabiri (US 2012/0136436 A1).
Regarding claim 16, Patel discloses An annuloplasty device (1100, docking device, fig. 19), said annuloplasty device comprising: a first support ring (1130, upper region, fig. 19) and a second support ring (1120, lower region, fig. 19) having a coiled configuration in which the first and second support rings are arranged as a coil around a central axis (fig. 19), wherein the first and second support rings are configured to be arranged on opposite sides of native heart valve leaflets of a heart valve (figs. 6-8) and the first and second support rings have respective free ends (31, proximal tip, 712, tip, fig. 22A); and a line (1163, line/suture, fig. 22A) attached at a proximal connection (1162, hole/bore, fig. 22A) at a proximal tip of a first end of one of the free ends (31, proximal tip, fig. 22A).
Patel fails to teach a projection wherein the width at the lumen in the radial direction is smaller than the width of the proximal tip in the radial direction. However, Cabiri discloses an annuloplasty device with a connection for a suture/line that includes the proximal connection comprises a projection extending from the proximal tip in the axial direction of the first end (37, suture fastener, fig. 1), wherein a lumen extends through the projection (47, hole, fig. 1) and wherein the projection at the lumen has a width (w1) in the radial direction smaller than a width (w2) of the proximal tip in the radial direction (see annotated fig. 1, below). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximal connection of Patel to include a projection wherein the width at the lumen in the radial direction is smaller than the width of the proximal tip in the radial direction as taught by Cabiri since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
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Regarding claim 17, Patel fails to teach the lumen is sized to receive a distal tip of the line. However, Cabiri further discloses the lumen is sized to receive a distal tip of the line (¶ [0345]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximal connection of Patel to include the lumen is sized to receive a distal tip of the line as taught by Cabiri since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 18, Patel further discloses the first end is configured to be compressed to clamp the distal tip of the line inside the lumen (31, proximal tip, fig. 22A). The phrase “the first end is configured to be compressed to clamp the distal tip of the line inside the lumen” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the proximal tip (¶ [0100] points to the coil being made of compressible and malleable materials) is considered to be capable of being compressed to claim the distal tip of the line inside the lumen.
Regarding claim 25, Patel fails to teach the lumen extends along a radial direction being perpendicular to the axial direction. However, Cabiri further discloses the lumen extends along a radial direction being perpendicular to the axial direction (fig. 1). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the proximal connection of Patel to include the lumen extends along a radial direction being perpendicular to the axial direction as taught by Cabiri since it is a simple substitution of one known element for another to obtain predictable results, which courts have recognized supports a conclusion of obviousness (see MPEP 2143).
Regarding claim 28, Patel further discloses the proximal connection is arranged at least partly at a surface of the proximal tip (see annotated fig. 19, below), the surface having a normal direction, the surface being angled such that a vector component of the normal direction is parallel with an axial direction of the first end (see annotated fig. 19, below).
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Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel in view of Cabiri as applied to claim 17 above, an further in view of Meier (US 2012/0121349 A1).
Regarding claim 19, Patel in view of Cabiri fails to teach the distal tip of the line comprises an expanded diameter portion. However, Meier discloses a tether locking device to be used with heart tissue that includes the distal tip of the line comprises an expanded diameter portion (2804, bulbous head, fig. 28A-B). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the line of Patel and Cabiri to include the distal tip of the line comprises an expanded diameter portion as taught by Meier in order to allow the plug to be translated in one direction within a hollow portion of a locking member, while not allowing the plug to be translated in another direction within the hollow portion of the locking member (¶ [0204], Meier).
Regarding claim 20, Patel in view of Cabiri fails to teach the expanded diameter portion is sized to be locked against a narrow section of the lumen. However, Meier further discloses the expanded diameter portion is sized to be locked against a narrow section of the lumen (¶ [0205]). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the line of Patel and Cabiri to include the expanded diameter portion is sized to be locked against a narrow section of the lumen as taught by Meier in order to prevent the plug from moving back out of the hollow portion (¶ [0205], Meier).
Regarding claim 21, Patel in view of Cabiri fails to teach the expanded diameter portion comprises an at least partly spherical portion or a hook-shaped portion. However, Meier further discloses the expanded diameter portion comprises an at least partly spherical portion (2804, bulbous head, fig. 28A-B). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the line of Patel and Cabiri to include the expanded diameter portion comprises an at least partly spherical portion or a hook-shaped portion as taught by Meier in order to prevent the plug from moving back out of the hollow portion (¶ [0205], Meier).
Conclusion
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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774