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 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 1-20 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 use of “substantially continuous concave longitudinal profile” is terminology of relative degree, which has no basis of comparison. For this reason, it is considered broad and relatively unlimited. The examiner asserts that the claimed physical property (in this case, substantially continuous concave longitudinal profile) is present in the prior art material to some extent even though it is not explicitly recited. Therefore, the examiner hereby burdens the applicant to show that this property is not present.
Claim 18 recites the limitation "the docking station" in line 1. There is insufficient antecedent basis for this limitation in the claim. For examination purposes the examiner interprets this term to be “the docking station frame.”
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) 1-2, 11 and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Letac et al. U.S. Publication 2011/0040375 A1.
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Regarding Claim 1, Letac et al. discloses a docking station frame 10 as seen in figures 3A-3B for a medical device, the docking station frame 10 comprising a plurality of strut portions extending from a proximal end 12 to a distal end 12 and forming a plurality of cells, wherein when the docking station frame 10 is in an expanded, unconstrained condition, the plurality of strut portions form a substantially continuous concave longitudinal profile (paragraphs [0054], [0077] and [0080]) having outer radial retaining portions at the proximal end and the distal end and an inner radial central portion defining a valve seat (as seen in Figure 3B).
Regarding Claim 2, Letac et al. discloses wherein the plurality of strut portions comprise a plurality of circumferential strut portions axially spaced to define a plurality of rows of the plurality of cells, and a plurality of longitudinal strut portions circumferentially spaced and joined with the plurality of circumferential strut portions to define the plurality of cells of the plurality of cells in each of the plurality of rows (as seen in the annotated Figure 3b above).
Regarding Claim 11, Letac et al. discloses wherein when the docking station frame is in the expanded, unconstrained condition, the inner radial central portion is substantially cylindrical (paragraphs [0038], [0054]).
Regarding Claim 15, Letac et al. discloses wherein the docking station frame is configured to be crimped to a diameter of no greater than about 5.4 mm (abstract and paragraphs [0075], [0078], [0084] and [0089]).
Regarding Claim 16, Letac et al. discloses wherein the concave longitudinal profile has a continuous radius of curvature between the proximal and distal ends and across the inner radial central portion (as seen in the annotated Figure 3B above).
Regarding Claim 17, Letac et al. discloses wherein the concave longitudinal profile has a radius of curvature that increases from each of the proximal and distal ends toward the inner radial central portion (as seen in the annotated Figure 3B above).
Claim(s) 1-7, 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cooper et al. U.S. Publication 2019/0262129 A1.
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Regarding Claim 1, Cooper et al. discloses a docking station frame 220 as seen in figures 5A-5E for a medical device, the docking station frame 220 comprising a plurality of strut portions extending from a proximal end to a distal end and forming a plurality of cells 134a, 134b (as seen in Figures 5A-5C and paragraph [0122]), wherein when the docking station frame 200 is in an expanded, unconstrained condition, the plurality of strut portions form a substantially continuous concave longitudinal profile (paragraphs [0131], [0134] and [0137] as seen in Figures 5A-5C) having outer radial retaining portions 104, 124 at the proximal end and the distal end (paragraphs [0127-0128] and [0130]) and an inner radial central portion defining a valve seat 262 (paragraph [0138] and as seen in Figures 5J-5K).
Regarding Claim 2, Cooper et al. discloses wherein the plurality of strut portions comprise a plurality of circumferential strut portions axially spaced to define a plurality of rows of the plurality of cells, and a plurality of longitudinal strut portions circumferentially spaced and joined with the plurality of circumferential strut portions to define the plurality of cells of the plurality of cells in each of the plurality of rows (as seen in the annotated Figure 3b above).
Regarding Claim 3, Cooper et al. discloses wherein the plurality of circumferential strut portions comprises at least five circumferential strut portions defining at least four rows of the plurality of cells (as seen in Figure 2 and paragraph [0122]).
Regarding Claim 4, Cooper et al. discloses wherein the plurality of longitudinal strut portions comprises at least twelve longitudinal strut portions defining at least twelve cells in each of the plurality of rows (as seen in the annotated Figure 5B).
Regarding Claim 5, Cooper et al. discloses wherein the plurality of circumferential strut portions comprises undulating strut portions (as seen in the annotated Figure 5B).
Regarding Claim 6, Cooper et al. discloses wherein a distal one of the undulating strut portions defines the outer radial retaining portion 104 at the distal end (as seen in Figures 5A-5B and paragraph [0127-0128]), and a proximal one of the undulating strut portions defines the outer radial retaining portion 124 at the proximal end (as seen in Figure 5A and 5B).
Regarding Claim 7, Cooper et al. discloses wherein each of the undulating strut portions includes proximal portions joined with a corresponding one of the plurality of longitudinal strut portions, and distal portions unattached from the plurality of longitudinal strut portions (as seen in the annotated Figure 5B).
Regarding Claim 11, Cooper et al. discloses wherein when the docking station frame is in the expanded, unconstrained condition, the inner radial central portion is substantially cylindrical (paragraph [0118]).
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) 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cooper et al. U.S. Publication 2019/0262129 A1 in view of Armer et al. U.S. Publication 2017/0231756 A1.
Regarding Claim 8, Cooper et al. discloses wherein when the docking station frame is in the expanded, unconstrained condition, the inner radial central portion has a diameter of about 27 mm to 29 mm (paragraph [0117-0118]). However, Cooper et al. does not expressly disclose the docking station frame is expandable to accommodate a valve having a diameter of about 29 mm. Armer et al. teaches a docking station in the same field of endeavor comprising a valve seat (abstract) having a diameter of 27 mm (paragraph [0211]), wherein the diameter increases no more than 3 mm (between 1 mm to 3 mm, see paragraph [0175]) by the radial outward force applied when expanding the docking station (paragraphs [0009] and [0011]), wherein the docking station in the expanded unconstrained condition has a diameter of 27 mm to 38 mm, preferably 29 mm (paragraphs [0011], [0016], [0175] and [0199]) for the purpose of conforming to the size of the valve. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Cooper’s valve seat to be 27 mm in diameter and a docking station to be expanded to 29 mm in diameter as taught by Armer et al. for the purpose of avoiding over expansion of the valve seat such that the valve would be securely held in the valve seat when the docking station is expanded to the native valve (paragraph [0175]).
Regarding Claim 9, Cooper et al. discloses wherein when the docking station frame is in the expanded, unconstrained condition has a diameter of about 27 mm to 29 mm (paragraph [0117-0118]). However, Cooper et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the docking station frame has a length between about 35 mm and about 40 mm. Armer et al. teaches a docking station in the same field of endeavor comprising a valve seat (abstract) and a docking station frame having a length of 27 mm to 38 mm for the purpose of enhancing the retention of the valve seat within the docking station and have a frame that can seal the implant to the vessel (paragraphs [0009-0011], [0013], [0016-0017]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Cooper’s docking station to have a diameter of about 35 mm to 40 mm as taught by Armer et al. for the purpose of enhancing the retention of the valve seat within the docking station and have a frame that can seal the implant to the vessel.
Regarding Claim 10, Cooper et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the outer radial retaining portions extend at an angle between about 30° and about 45° with respect to a central longitudinal axis of the docking station frame. Armer et al. teaches a docking station in the same field of endeavor comprising a valve seat (abstract) and a docking station frame having an outer radial retaining portions 414 on the proximal and distal ends 12, 14 (see Figures 15A-15B), wherein the retaining portions extend at an angle between 30 to 50 degrees, preferably about 45 degrees (paragraph [0196]) for the purpose of having flared portions that engage into the surrounding anatomy and locks the device in place (paragraph [0196]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Cooper’s retaining portions to extend between 30 to 45 degrees as taught by Armer et al. for the purpose of having flared portions that engage into the surrounding anatomy and locks the device in place.
Claim(s) 9-10, 12, 14 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Letac et al. U.S. Publication 2011/0040375 A1 in view of Armer et al. U.S. Publication 2017/0231756 A1.
Regarding Claim 9, Letac et al. discloses the docking station frame 10 in an expanded state has a diameter of 23 mm (see paragraphs [0099-0101], [0112]). However, Letac et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the docking station frame has a length between about 35 mm and about 40 mm. Armer et al. teaches a docking station in the same field of endeavor comprising a valve seat (abstract) and a docking station frame having a length of 27 mm to 38 mm for the purpose of enhancing the retention of the valve seat within the docking station and have a frame that can seal the implant to the vessel (paragraphs [0009-0011], [0013], [0016-0017]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Letac’s docking station to have a diameter of about 35 mm to 40 mm as taught by Armer et al. for the purpose of enhancing the retention of the valve seat within the docking station and have a frame that can seal the implant to the vessel.
Regarding Claim 10, Letac et al. discloses an outer radial retaining portions on the proximal and distal ends (see annotated Figure 3B above). However, Letac et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the outer radial retaining portions extend at an angle between about 30° and about 45° with respect to a central longitudinal axis of the docking station frame. Armer et al. teaches a docking station in the same field of endeavor comprising a valve seat (abstract) and a docking station frame having an outer radial retaining portions 414 on the proximal and distal ends 12, 14 (see Figures 15A-15B), wherein the retaining portions extend at an angle between 30 to 50 degrees, preferably about 45 degrees (paragraph [0196]) for the purpose of having flared portions that engage into the surrounding anatomy and locks the device in place (paragraph [0196]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Letac’s retaining portions to extend between 30 to 45 degrees as taught by Armer et al. for the purpose of having flared portions that engage into the surrounding anatomy and locks the device in place.
Regarding Claim 12, Letac et al. discloses the height of the expanded frame 10 is preferably 10 to 15 mm (paragraph [0082]), the frame is expanded by a balloon 26 that has a length of 3 to 4 cm in its cylindrical part which corresponds to the inner radial central portion (see Figure 12A, paragraph [0145]). However, Letac et al. does not expressly disclose wherein the substantially cylindrical inner radial central portion has a length of about 3 mm to about 6 mm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the length of the central portion of the cylindrical frame to be about 3 mm to about 6 mm to accommodate the balloon to be placed within the valve (paragraph [0145]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding Claim 14, Letac et al. discloses the height of the expanded frame 10 is preferably 10 to 15 mm (paragraph [0082]), therefore, the central portion is capable of having at least 8 mm. However, Letac et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the valve having a deployed outer diameter of 29 mm. Armer et al. teaches a docking station in the same field of endeavor comprising a docking station in the expanded unconstrained condition having a diameter of 27 mm to 38 mm, preferably 29 mm (paragraphs [0011], [0016], [0175] and [0199]) for the purpose of conforming to the size of the valve. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Letac’s docking station to be expanded to 29 mm in diameter as taught by Armer et al. for the purpose of avoiding over expansion of the valve seat such that the valve would be securely held in the valve seat when the docking station is expanded to the native valve (paragraph [0175]).
Regarding Claim 19, Letac et al. discloses a docking station frame 10 as seen in figures 3A-3B for a medical device, the docking station frame 10 comprising a plurality of strut portions extending from a proximal end 12 to a distal end 12 and forming a plurality of cells, wherein when the docking station frame 10 is in an expanded, unconstrained condition, the plurality of strut portions form outer radial retaining portions at the proximal end and the distal end extending at an angle (as seen in the annotated Figure 3B and paragraphs [0054], [0077] and [0080]). However, Letac et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the outer radial retaining portions extend at an angle between about 30° and about 45° with respect to a central longitudinal axis of the docking station frame. Armer et al. teaches a docking station in the same field of endeavor comprising a valve seat (abstract) and a docking station frame having an outer radial retaining portions 414 on the proximal and distal ends 12, 14 (see Figures 15A-15B), wherein the retaining portions extend at an angle between 30 to 50 degrees, preferably about 45 degrees (paragraph [0196]) for the purpose of having flared portions that engage into the surrounding anatomy and locks the device in place (paragraph [0196]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Letac’s retaining portions to extend between 30 to 45 degrees as taught by Armer et al. for the purpose of having flared portions that engage into the surrounding anatomy and locks the device in place.
Claim(s) 13 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Letac et al. U.S. Publication 2011/0040375 A1 in view of Wallace et al. U.S. Publication 2016/0158003 A1.
Regarding Claim 13, Letac et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the outer radial retaining portions have a radius of curvature of between about 14 mm and about 20 mm. Wallace et al. teaches a docking station frame in the same field of endeavor comprising a continuous curved profile (see Figures 1-2) having an outer radial retaining portions 2, 4 (paragraph [0044], [0046]), wherein the retaining portions 2, 4, comprises curvature having a length between 15 to 20 mm, more preferably 20 mm (paragraph [0074]) for the purpose of having arches having a shorter length to increase the stiffness of the anchor (paragraph [0074]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Letac’s retaining portions to include a radius of curvature having a length of 20 mm as taught by Wallace et al. for the purpose of having arches having a shorter length to increase the stiffness of the anchor.
Regarding Claim 20, Letac et al. discloses a docking station frame 10 as seen in figures 3A-3B for a medical device, the docking station frame 10 comprising a plurality of strut portions extending from a proximal end 12 to a distal end 12 and forming a plurality of cells, wherein when the docking station frame 10 is in an expanded, unconstrained condition, the plurality of strut portions form outer radial retaining portions at the proximal end and the distal end extending at an angle (as seen in the annotated Figure 3B and paragraphs [0054], [0077] and [0080]). the plurality of strut portions form a curved longitudinal profile (paragraphs [0054], [0077] and [0080]) having outer radial retaining portions at the proximal end and the distal end and an inner radial central portion defining a valve seat, the inner radial central portion being substantially cylindrical (paragraphs [0038], [0054]). However, Letac et al. does not expressly disclose wherein when the docking station frame is in the expanded, unconstrained condition, the outer radial retaining portions have a radius of curvature of between about 14 mm and about 20 mm. Wallace et al. teaches a docking station frame in the same field of endeavor comprising a continuous curved profile (see Figures 1-2) having an outer radial retaining portions 2, 4 (paragraph [0044], [0046]), wherein the retaining portions 2, 4, comprises curvature having a length between 15 to 20 mm, more preferably 20 mm (paragraph [0074]) for the purpose of having arches having a shorter length to increase the stiffness of the anchor (paragraph [0074]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Letac’s retaining portions to include a radius of curvature having a length of 20 mm as taught by Wallace et al. for the purpose of having arches having a shorter length to increase the stiffness of the anchor.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Letac et al. U.S. Publication 2011/0040375 A1 in view of Buchbinder et al. U.S. Publication 2012/0059458 A1.
Regarding Claim 18, Letac does not expressly disclose the docking station further comprising a plurality of radiopaque markers disposed around the proximal end of the docking station frame. Buchbinder et al. teaches a docking station frame as seen in figures 4A-4D in the same field of endeavor comprising a proximal and a distal retaining portions 58, 62, and a valve seat (see Figure 4A-4D) wherein the retaining portions of the docking station frame comprises radiopaque markers for the purpose of assisting in the proper orientation of the valve support (paragraph [0066]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Letac’s docking station frame to further include radiopaque markers on the retaining portions as taught by Buchbinder et al. for the purpose of assisting in the proper orientation of the valve support.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEEMA MATHEW whose telephone number is (571) 270-1452. The examiner can normally be reached on Monday-Friday 9 am – 5 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE, Melanie Tyson at (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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/SEEMA MATHEW/
Primary Examiner, Art Unit 3774
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