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 .
Information Disclosure Statement
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); 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).
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Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 12,053,371. Although the claims at issue are not identical, they are not patentably distinct from each other because the Patent discloses:
Regarding Claim 1, the Patent discloses a delivery system for delivering an anchor to a diseased native valve of a heart (column 18, lines 2-3), comprising: an anchor control catheter (column 18, line 4); and an anchor guide extending from the anchor control catheter (column 18, lines 5-6), the anchor guide comprising a flexible configuration with an elongate delivery geometry and a rigid configuration with a curved deployed geometry (column 18, lines 6-8), the anchor guide in the rigid configuration comprises a proximal section, a middle section, and a distal section (column 18, lines 8-10), wherein the proximal section comprises a straight central axis and extends from the anchor control catheter (column 18, lines 11-12), the middle section spirals axially and radially outwards from the straight central axis (column 18, lines 13-14), and the distal section curves about the straight central axis (column 18, lines 14-15), wherein the anchor guide is shape-set to assume an intermediate configuration that has an intermediate geometry that is between the elongate delivery geometry and the curved deployed geometry (column 18, lines 16-19).
Regarding Claim 2, the Patent discloses wherein the anchor guide comprises a plurality of cuts configured to define a shape of the anchor guide in the rigid configuration (column 18, lines 20-22).
Regarding Claim 3, the Patent discloses wherein the plurality of cuts comprises window cuts, interlocking spiral cuts, or toothed wedge cuts (column 18, lines 23-25).
Regarding Claim 4, the Patent discloses further comprising one or more actuation elements configured to actuate the anchor guide from the flexible configuration to the rigid configuration (column 18, lines 26-29).
Regarding Claim 5, the Patent discloses wherein the one or more actuation elements comprises a nested concentric shaft mechanism or one or more pullwires or cables (column 18, lines 30-32).
Regarding Claim 6, the Patent discloses wherein the anchor guide comprises a shape memory material (column 18, lines 33-34).
Regarding Claim 7, the Patent discloses wherein the anchor guide comprises a central channel configured to hold the anchor therein (column 18, lines 35-37).
Regarding Claim 8, the Patent discloses wherein the anchor guide is configured to deflect the anchor positioned within the central channel when the anchor guide is transitioned from the flexible configuration to the rigid configuration (column 18, lines 38-41).
Regarding Claim 9, the Patent discloses wherein the anchor guide is configured to position the anchor concentrically relative to a central axis of the anchor control catheter (column 18, lines 42-44).
Regarding Claim 10, the Patent discloses wherein the anchor guide in the flexible configuration is configured to be positioned within a delivery sheath (column 18, lines 45-47).
Regarding Claim 11, the Patent discloses a delivery system for delivering an anchor to a diseased native valve of a heart (column 18, lines 2-3), comprising: an anchor control catheter (column 18, line 4); and an anchor guide extending from the anchor control catheter (column 18, lines 5-6), the anchor guide comprising an elongate delivery geometry (column 18, lines 6-8), and a spiral deployed geometry that comprises a proximal section, a middle section, and a distal section (column 18, lines 8-10), wherein the proximal section comprises a straight central axis and extends from the anchor control catheter (column 18, lines 11-12), the middle section spirals axially and radially outwards from the straight central axis (column 18, lines 13-14), and the distal section curves about the central axis (column 18, lines 14-15), wherein upon deployment the anchor guide is biased to assume an intermediate geometry that is between the elongate delivery geometry and the spiral deployed geometry (the claim discloses the intermediate geometry is between the elongate delivery geometry and the curved deployed geometry, therefore a curved deployed geometry can be interpreted to be spiral- having curves, see column 18, lines 16-19).
Regarding Claim 12, the Patent discloses wherein the anchor guide comprises a plurality of cuts configured to define a shape of the anchor guide in the rigid configuration (column 18, lines 20-22).
Regarding Claim 13, the Patent discloses wherein the plurality of cuts comprises window cuts, interlocking spiral cuts, or toothed wedge cuts (column 18, lines 23-25).
Regarding Claim 14, the Patent discloses further comprising one or more actuation elements configured to actuate the anchor guide from the flexible configuration to the rigid configuration (column 18, lines 26-29).
Regarding Claim 15, the Patent discloses wherein the one or more actuation elements comprises a nested concentric shaft mechanism or one or more pullwires or cables (column 18, lines 30-32).
Regarding Claim 16, the Patent discloses wherein the anchor guide comprises a shape memory material (column 18, lines 33-34).
Regarding Claim 17, the Patent discloses wherein the anchor guide comprises a central channel configured to hold the anchor therein (column 18, lines 35-37).
Regarding Claim 18, the Patent discloses wherein the anchor guide is configured to deflect the anchor positioned within the central channel when the anchor guide is transitioned from the flexible configuration to the rigid configuration (column 18, lines 38-41).
Regarding Claim 19, the Patent discloses wherein the anchor guide is configured to position the anchor concentrically relative to a central axis of the anchor control catheter (column 18, lines 42-44).
Regarding Claim 20, the Patent discloses a delivery system for delivering an anchor to a diseased native valve of a heart (column 18, lines 2-3), comprising: an anchor control catheter (column 18, line 4); and an anchor guide extending from the anchor control catheter (column 18, lines 5-6), the anchor guide comprising a delivery configuration having an elongate geometry (column 18, lines 6-7), and a deployed configuration having a curved geometry (column 18, lines 6-8) that comprises a proximal section, a middle section, and a distal section (column 18, lines 8-10), wherein the proximal section comprises a straight central axis and extends from the anchor control catheter (column 18, lines 11-12), the middle section spirals axially and radially outwards from the straight central axis (column 18, lines 13-14), and the distal section curves about the central axis (column 18, lines 14-15), wherein upon deployment the anchor guide is biased to assume an intermediate configuration that has an intermediate geometry with less curvature than the anchor guide in the deployed geometry (the claim states the intermediate is in between the elongate delivery geometry and the curved deployed geometry, therefore the intermediate geometry is less curvature than the deployed geometry, see column 18, lines 16-19).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Patel et al. U.S. Publication 2018/0318079. Patel et al. discloses a delivery system 2 (see Figures 2A-3B) for delivering an anchor 1 to a diseased native valve of a heart (paragraph [0076] and [0083-0090]), comprising an anchor control catheter 20; and an anchor guide 24 extending from the anchor control catheter 20 (paragraphs [0083-0085] and as seen in Figures 2A-2B), the anchor guide comprising a delivery configuration having an elongate geometry (the curved middle section spirals away from a straight region, see paragraph 2B and paragraph [0083-0085]), and a deployed configuration having a curved geometry that comprises a proximal section , a middle section, and a distal section (as seen in Figures 2B), wherein the proximal section comprises a straight central axis (before the curve) and extends from the anchor control catheter 20 (as seen in Figure 2B), the middle section spirals axially and radially outwards from the straight central axis (portion before 25), and the distal section 25 curves about the central axis (as seen in Figure 2B). However, the prior art fails to teach nor render obvious wherein upon deployment the anchor guide is biased to assume an intermediate configuration that has an intermediate geometry with less curvature than the anchor guide in the deployed geometry.
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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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