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 .
The first inventor to file provisions of the Leahy-Smith America Invents Act (AIA ) apply to any application for patent, and to any patent issuing thereon, that contains or contained at any time—
(A) a claim to a claimed invention that has an effective filing date on or after March 16, 2013 wherein the effective filing date is:
(i) if subparagraph (ii) does not apply, the actual filing date of the patent or the application for the patent containing a claim to the invention; or
(ii) the filing date of the earliest application for which the patent or application is entitled, as to such invention, to a right of priority under 35 U.S.C. 119, 365(a), or 365(b) or to the benefit of an earlier filing date under 35 U.S.C. 120, 121, or 365(c); or
(B) a specific reference under 35 U.S.C. 120 , 121, or 365(c), to any patent or application that contains or contained at any time a claim as defined in paragraph (A), above.
Status of the Claims
Claim(s) 1-22 is/are pending.
Claim Objections
Claim 12 is objected to because of the following informalities:
Claim 12 recites “super elastic rod or wire”, which should be “a super elastic rod or wire”.
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application will determine what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims see Table I below rejected on the ground of nonstatutory double patenting as being unpatentable over claims see Table I below of U.S. Patent No. see Table I below. Although the claims at issue are not identical, they are not patentably distinct from each other because the following prior claims contain the limitations claimed by the current Application as indicated in the following table.
Table I
Current Application
Prior Patent
US 10,828,150
1-2, 7
1
4
7
6
4
8
8
9
6
12-13
11
15
15
17
12
18
17
19
18
20
13-14
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 1-11, 16-17, and 19-22 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.
The term "downward" in claims 1, 8, and 19 is a relative term which renders the claim indefinite. The term "downward" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, this term is indefinite.
The term "below" in claims 1, 9, and 20 is a relative term which renders the claim indefinite. The term "below" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, this term is indefinite.
The term "about" in claims 5-6, 9-11, 16-17, and 20-22 is a relative term which renders the claim indefinite. The term "about" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure provides no metric for determining the bounds of “about” (such as standard deviation or another metric). Therefore, this term is indefinite.
The term "downwardly" in claims 8 and 19 is a relative term which renders the claim indefinite. The term "downwardly" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, this term is indefinite.
Claim(s) 2-4 and 7 are rejected as dependent from a rejected claim.
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.
Claim(s) 1-3, 7-8, 12-14, and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schweich, et al (Schweich) (US 2013/0282110 A1).
Regarding Claim 1, Schweich teaches a docking station (e.g. Figures 6-7, 9-10) for an expandable heart valve (e.g. [0041], [0042]), the docking station being implantable at a native mitral valve having an annulus and leaflets (e.g. [0041], [0042]), comprising:
a super elastic (e.g. [0210]) rod or wire forming a continuous, closed shape (e.g. Figures 6-7, 9-10) defining:
an atrial ring arranged around a central axis (e.g. Figure 9) and sized to circumscribe the native annulus (e.g. Figure 9) including two ring portions lying in a common plane (e.g. Figure 9), the two ring portions being separated at pairs of adjacent ends by gaps (e.g. Figure 9; annotated Figure 9 below, a portion is on each side of the dashed line);
a descending bend commencing at each end of the two ring portions extending downward generally perpendicularly from the common plane (e.g. annotated Figure 7 below); and
a pair of generally arcuate arms extending from adjacent descending bends below the common plane of the atrial ring with apices pointed away from each other (e.g. annotated Figure 7 below; circled arms), wherein the arms are each curved generally around the central axis (e.g. Figure 6) and each have a radius less than a radius of the atrial ring (e.g. Figures 7, 9-10; the entire size of the arms are each less than a radius of the atrial ring and thus must have arm radii less than the ring radius), the two ring portions being flexibly connected through the arms (e.g. Figures 6-7, 9-10), and wherein
the docking station is configured such that it does not significantly interfere with the native leaflets after the docking station is installed to allow functioning of the mitral heart valve before expansion of the expandable heart valve within the mitral heart valve (e.g. Figures 6, 9; the docking station is placed such that when implanted alone, the native leaflets remain able to move and coapt; however, [0217]).
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430
382
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335
508
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Annotated Figure 9, Schweich
Annotated Figure 7, Schweich
Regarding Claim 2, the atrial ring defines a circular or oval peripheral shape (e.g. Figure 9).
Regarding Claim 3, the central axis is a Z-axis, and the docking station defines perpendicular X- and Y-axes within the common plane, with the X-axis extending across the atrial ring and intersecting the gaps between the pairs of adjacent ends of the ring portions (the coordinate system overlayed on the device is considered to be as claimed), and wherein the docking station is symmetric about a plane defined by the X- and Z-axes (e.g. Figure 9).
Regarding Claim 7, the arms each have a rounded V-shape formed by an upper strut, a curved end defining an apex of the arm, and a lower strut (e.g. annotated Figure 7 above), and the lower strut of each pair of arms connects to the lower strut on the other arm of that pair (e.g. annotated Figure 7 above).
Regarding Claim 8, the lower strut on each arm of each pair connects to the lower strut on the other arm of that pair via a downwardly curved bridge portion that extends downward from the lower struts (e.g. annotated Figure 7 above).
Regarding Claim 12, Schweich teaches a docking station (e.g. Figures 6-7, 9-10) for an expandable heart valve (e.g. [0041], [0042]), the docking station being implantable at a native mitral valve having an annulus and leaflets (e.g. [0041], [0042]), comprising:
[a] super elastic (e.g. [0210]) rod or wire forming a continuous, closed shape (e.g. Figures 6-7, 9-10) defining:
two half rings arranged around a central axis (e.g. Figure 9) and separated at two pairs of adjacent end gaps (e.g. Figure 9; annotated Figure 9 below, a portion is on each side of the dashed line), the two half rings defining an incomplete atrial ring (e.g. Figures 7, 9) sized to fit around the native annulus (e.g. Figure 9); and
a pair of ventricular anchors each connected to a pair of adjacent ends of the half rings and axially spaced from the half rings (e.g. Figure 7), each of the ventricular anchors having two arms extending away from each other (e.g. annotated Figure 7 above), and each ventricular anchor being curved generally around the central axis (e.g. Figure 6) and formed by bends in the super elastic rod or wire (e.g. Figures 7, 9) to enable the two half rings to elastically flex apart (e.g. [0202]; the material is flexible and thus able to perform the claimed function), and wherein
the docking station is configured such that it does not significantly interfere with the native leaflets after the docking station is installed to allow functioning of the mitral heart valve before expansion of the expandable heart valve within the mitral heart valve (e.g. Figures 6, 9; the docking station is placed such that when implanted alone, the native leaflets remain able to move and coapt; however, [0217]).
Regarding Claim 13, the atrial ring generally defines a circular or oval peripheral shape in a common plane (e.g. Figure 9).
Regarding Claim 14, the central axis is a Z-axis, and the docking station defines perpendicular X- and Y-axes within the common plane, with the X-axis extending across the atrial ring and intersecting the gaps between the pairs of adjacent ends of the ring portions (the coordinate system overlayed on the device is considered to be as claimed), and wherein the docking station is symmetric about a plane defined by the X- and Z-axes (e.g. Figure 9).
Regarding Claim 18, the arms each have a rounded V-shape formed by an upper strut, a curved end defining an apex of the arm, and a lower strut (e.g. annotated Figure 7 above), and the lower strut of each pair of arms connects to the lower strut on the other arm of that pair (e.g. annotated Figure 7 above).
Regarding Claim 19, the lower strut on each arm of each pair connects to the lower strut on the other arm of that pair via a downwardly curved bridge portion that extends downward from the lower struts (e.g. annotated Figure 7 above).
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 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.
Claims 4-6, 9-11, 15-17, and 20-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schweich, et al (Schweich) (US 2013/0282110 A1) as discussed supra, alone.
Regarding Claims 4 and 15, Schweich discloses the invention substantially as claimed but fails to teach the at least two ring portions are two half rings and an angular span of each half ring is between 170-178°.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schweich such that the at least two ring portions are two half rings and an angular span of each half ring is between 170-178° as such a modification would have been an obvious matter of design choice involving a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04 IV).
Regarding Claims 5-6 and 16-17, Schweich discloses the invention substantially as claimed but fails to teach:
(1) a diameter of the first ring is between about 25-33 mm,
(2) the gaps have a width of between 1-6 mm, and
(3) the arms having a radius of curvature that is about 2-3 mm less than the radius of curvature of the atrial ring.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schweich such that (1) a diameter of the first ring is between about 25-33 mm, (2) the gaps have a width of between 1-6 mm, and (3) the arms having a radius of curvature that is about 2-3 mm less than the radius of curvature of the first ring as such modifications would have been an obvious matter of design choice involving a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04 IV).
Regarding Claims 9-11 and 20-22, Schweich discloses the invention substantially as claimed but fails to teach the specific dimensions of the claimed ranges.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Schweich such that (1) the arms each descend down below the horizontal plane of the atrial ring to a depth of between about 10-15 mm, (2) the arms each define an angular span θ of between about 30o-60º, and (3) the arms each define an angular span θ of between about 10-20 mm as such modifications would have been an obvious matter of design choice involving a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art and it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (see MPEP 2144.04 IV).
Relevant Prior Art
US 2005/0010287 A1 to Macoviak teaches a docking station of a super elastic wire formed into two half rings as claimed in at least claims 1 and 12 (e.g. Figure 9B).
US 2014/0200662 A1 to Eftel, et al teaches a docking station for a heart valve implant (e.g. Figure 5).
US 2015/0112433 A1 to Schweich, et al teaches a docking station for a heart valve implant (e.g. Figures 22-23).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE A LOPEZ whose telephone number is (571)270-7044. The examiner can normally be reached 8:30 AM - 5:30 PM, MST.
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/LESLIE A LOPEZ/Primary Examiner, Art Unit 3774 9/16/2026
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