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 § 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 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Taft (US 2017/0106176).
Regarding claim 11, Taft discloses shunt implant device comprising:
a shunt barrel (170a and 170b) formed at least in part by a plurality of arcuate panels (sidewalls 170a and 170b) configured in an at least partially cylindrical form (figure 6B);
a first anchor arm (154b) projecting from a first axial side of the shunt barrel and deflected radially outward in a first radial direction (figure 6A); and
a second anchor arm (152b) projecting from a second axial side of the shunt barrel and deflected radially outward in the first radial direction (figure 6A).
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) 1-10, 12-14, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taft (US 2017/0106176) in view of Popp (US 2021/0378824).
Regarding claim 1, Taft discloses a shunt implant device (figure 6A) comprising: one or more anchor arms (152b and 154b, [0086]; and a tubular barrel (170a and 170b) formed by and first and second barrel wings (170a and 170b) but fails to teach the wings configured to curve and overlap to form a tubular barrel form.
Popp discloses a frame for a stent (figure 4E, [0051]) comprising first and second barrel wings configured to curve and overlap to form a tubular barrel form ([0054], see annotated figure below).
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Popp provides a variety of forms for the frames including the overlap embodiment to improve the strength of the frame ([0054]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Taft by substituting/modifying the form of the frame to include overlapping segments in order to improve the strength of the frame.
Regarding claim 2, Taft does not disclose wherein the first and second barrel wings are configured to be inwardly deflected such that distal portions of the first and second barrel wings are circumferentially overlapped.
Popp discloses a frame for a stent ([0051]) comprising first and second barrel wings wherein the first and second barrel wings are configured to be inwardly deflected such that distal portions of the first and second barrel wings are circumferentially overlapped. ([0054], see annotated figure above).
Popp provides a variety of forms for the frames including the overlap embodiment to improve the strength of the frame ([0054]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Taft by substituting/modifying the form of the frame to include overlapping segments in order to improve the strength of the frame.
Regarding claim 3, Taft does not disclose wherein distal edges of the first and second barrel wings are curved towards one another and disposed proximate to one another when the first and second barrel wings form the tubular barrel form.
Popp discloses a frame for a stent ([0051]) comprising first and second barrel wings wherein distal edges of the first and second barrel wings are curved towards one another and disposed proximate to one another when the first and second barrel wings form the tubular barrel form (see figure 4E).
Popp provides a variety of forms for the frames including the overlap embodiment to improve the strength of the frame ([0054]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Taft by substituting/modifying the form of the frame to include overlapping segments in order to improve the strength of the frame.
Regarding claim 4, Taft discloses wherein the one or more anchor arms and the first and second barrel wings project from a backbone support structure of the shunt implant device (see annotated figure 6B below).
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Regarding claim 5, Taft discloses wherein, in a flattened configuration the one or more anchor arms project in a first dimension ( figures 6A, the anchor arms project outward), and the first and second barrel wings project in a second dimension that is perpendicular to the first dimension (figure 6C, [0083]) .
Regarding claims 6 and 7, Taft further discloses wherein the first and second barrel wings each comprise a plurality of lateral struts (170b) separated by one or more lateral slit gaps (figure 6A, gaps between the struts, [0083]) and, wherein the first and second barrel wings each comprise a plurality of vertical struts (170a) separated by one or more vertical slit gaps (figure 6A, gaps between the struts, [0083]).
Regarding claim 8, Taft further discloses wherein the first and second barrel wings comprise struts (179) forming one or more rows of polygonal cells (figure 6A, [0081]).
Regarding claim 9, Taft further discloses wherein the tubular barrel form has an axis (176, [0083]) that is angled relative to a tissue plane associated with the shunt implant device (figure 10).
Regarding claim 10, Taft further discloses, wherein at least one of the one or more anchor arms comprises a sensor-retention means (192 aperture,[0095]) configured to secure a sensor device to the shunt implant device (can perform the intended use of attaching a device to the shunt device through the use of the opening).
Regarding claim 12, Taft does not disclose, wherein the shunt barrel includes an axial gap formed between distal edges of the plurality of arcuate panels.
Popp discloses a shunt barrel including an axial gap between the distal edges of the arcuate panels ([0054]).
Popp provides a variety of forms for the frames including the overlap embodiment to improve the strength of the frame ([0054]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Taft by substituting/modifying the form of the frame to include overlapping segments in order to improve the strength of the frame.
Regarding claim 13, Taft discloses wherein the plurality of arcuate panels are coupled by a backbone structure (see annotated figure 6B above), which would be diametrically opposite the axial gap of Popp.
Regarding claim 14, Taft discloses the backbone structure comprises at least one axial strut (struts throughout the sidewall in figure 6A-6B).
Regarding claims 16-19, Taft does not disclose wherein the plurality of arcuate panels are configured to assume a compressed delivery configuration in which a first one of the plurality of arcuate panels is deflected radially inside of, and circumferentially overlapping, a second one of the plurality of arcuate panels (claim 16). wherein, in an expanded configuration, the first and second ones of the plurality of arcuate panels are radially aligned (claim 17). wherein contact between edges of the plurality of arcuate panels prevents radial compression of the shunt barrel (claim 18). wherein, when the plurality of arcuate panels are in the compressed delivery configuration, the shunt barrel has a diameter that is less than a diameter of the shunt barrel in an expanded configuration in which the first and second ones of the plurality of arcuate panels are radially aligned (claim 19).
Popp discloses a frame for a stent ([0051]) wherein the plurality of arcuate panels are configured to assume a compressed delivery configuration in which a first one of the plurality of arcuate panels is deflected radially inside of, and circumferentially overlapping, a second one of the plurality of arcuate panels (figure 4E, [0054])). wherein, in an expanded configuration, the first and second ones of the plurality of arcuate panels are radially aligned (figure 4B). wherein contact between edges of the plurality of arcuate panels prevents radial compression of the shunt barrel (figure 4B). wherein, when the plurality of arcuate panels are in the compressed delivery configuration, the shunt barrel has a diameter that is less than a diameter of the shunt barrel in an expanded configuration in which the first and second ones of the plurality of arcuate panels are radially aligned ([0054]).
Popp provides a variety of forms for the frames including the overlap embodiment to improve the strength of the frame ([0054]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Taft by substituting/modifying the form of the frame to include overlapping segments in order to improve the strength of the frame.
Regarding claim 20, Taft discloses a method of shunting fluid, the method comprising:
providing a shunt device comprising one or more anchor arms (152b and 154b, figure 6A) and first and second barrel wings (170a and 170b) configured to curve to form a tubular barrel form (figure 6B);
advancing the shunt device to a target tissue wall within a patient ([0020]);
forming an opening in the target tissue wall ([0023]);
deploying the one or more anchor arms on one or more sides of the target tissue wall ([0029]);
deploying the first and second barrel wings within the opening ([0029]);
shunting blood through the tubular barrel form ([0029-0030]).
Taft does not teach configuring the shunt device in a compressed delivery configuration by inwardly deflecting at least one of the first and second barrel wings to cause the first and second barrel wings to overlap, thereby reducing a diameter of the shunt device;
disposing the shunt device in the compressed delivery configuration in a delivery catheter;
expanding the first and second barrel wings within the opening to form the tubular barrel form; and
Popp discloses configuring the shunt device in a compressed delivery configuration (figure 4E) by inwardly deflecting at least one of the first and second barrel wings to cause the first and second barrel wings to overlap ([0012], [0054]), thereby reducing a diameter of the shunt device;
disposing the shunt device in the compressed delivery configuration in a delivery catheter ([0054]);
expanding the first and second barrel wings within the opening to form the tubular barrel form ([0054]).
Popp provides a variety of forms for the frames including the overlap embodiment to improve the strength of the frame ([0054]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Taft by substituting/modifying the form of the frame to include overlapping segments in order to improve the strength of the frame.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taft (US 2017/0106176) in view of Popp (US 2021/0378824) further in view of Rowe (US 2022/0008014).
Regarding claim 15, Taft and Popp do not teach further comprising a pressure sensor device, wherein the pressure sensor device is secured to the first anchor arm by a plurality of sensor-retention fingers projecting from the first anchor arm.
Rowe discloses a shunt comprising a pressure sensor (2410, figures 24-25), wherein the pressure sensor device is secured to the first anchor arm by a plurality of sensor-retention fingers (2474, [0138-0139]) projecting from the first anchor arm (figures 24-25).
Rowe provides the sensor in order to monitor conditions in the body ([0049]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Taft and Popp with the sensor device of Rowe in order to monitor conditions in the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KAI H WENG/Primary Examiner, Art Unit 3781
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