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 Objections
Claim 18 is objected to because of the following informalities: the claim recites “Claim16” which should read “Claim 16”. Appropriate correction is required.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 10, 11, 16, 17, 19, and 20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Corbett et al (US 2017/0340787, hereinafter “Corbett”).
Regarding claim 1, Corbett discloses a percutaneous circulatory support device (par 0001-0002, 0005), comprising: an impeller portion (par 0078) comprising: a distal end portion (par 0078); a proximal end portion (par 0078); and an impeller being rotatable to cause blood to flow through the percutaneous circulatory support device (par 0001-0002, 0078); a cannula coupled to the distal end portion (par 0078); and a catheter coupled to the proximal end portion, the catheter comprising a preformed curve having a radius in a range of 2.00 inches to 0.25 inches (par 0078, 0081, 0091).
Regarding claim 2, Corbett discloses the radius of the preformed curve is in a range of 1.50 inches to 0.90 inches (par 0078, 0081).
Regarding claim 10, Corbett discloses the preformed curve is a preformed catheter curve, and the cannula comprises a preformed cannula curve (par 0091).
Regarding claim 11, Corbett discloses the preformed catheter curve and the preformed cannula curve are disposed in a common plane (par 0106).
Regarding claim 16, Corbett discloses a method of manufacturing a percutaneous circulatory support device (par 0001-0002, 0005), the method comprising: providing an impeller portion comprising a distal end portion, a proximal end portion, and a rotatable impeller (par 0001-0002, par 0078); coupling a cannula to the distal end portion (par 0078); and coupling a catheter to the proximal end portion, the catheter comprising a preformed curve having a radius in a range of 2.00 inches to 0.25 inches (pars 0078, 0081, 0091).
Regarding claim 17, Corbett discloses the preformed curve comprises an arc length in a range of 1.88 inches to 0.63 inches (par 0078, 0081).
Regarding claim 19, Corbett discloses the preformed curve is a preformed catheter curve, and the cannula comprises a preformed cannula curve (par 0091).
Regarding claim 20, Corbett discloses the preformed catheter curve and the preformed cannula curve are disposed in a common plane (par 0106).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 4, 5, 6, 7, 8, 9, 12, 13, 14, 15, and 18 rejected under 35 U.S.C. 103 as being unpatentable over Corbett.
Regarding claim 3, Corbett discloses the claimed invention including details about the shaping of the device (par 0106, 0115) as well as shape features for assisting with navigating the device through locations in the body such as the aortic arch (par 0103-0106). Corbett discloses the various curves and locations (par 0078, 0081, 0091) and modifications to the structure to fit the anatomy of the patient (par 0115), including as shown in figures 1, 3, and 6. Corbett, however, does not explicitly disclose the radius of the preformed curve is in a range of 1.40 inches to 1.00 inches. Corbett does, however, note that the shape of the device may include variations in sizes, shapes, proportions (par 0115) to established curves, angles, and shapes (pars 0106; figures 1, 3, 6). Therefore, the disclosure of Corbett encompasses a modification that includes the radius of the preformed curve in a range of 1.40 inches to 1.00 inches as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Corbett to include the radius of the preformed curve in a range of 1.40 inches to 1.00 inches, since such a modification would provide the predictable results of shaping modifications that facilitate insertion of the pump assembly into the body.
Regarding claims 4, 5, and 6, Corbett discloses the claimed invention including details about the shaping of the device (par 0106, 0115) as well as shape features for assisting with navigating the device through locations in the body such as the aortic arch (par 0103-0106). Corbett discloses the various curves and locations (par 0078, 0081, 0091) and modifications to the structure to fit the anatomy of the patient (par 0115), including as shown in figures 1, 3, and 6. Corbett, however, does not explicitly disclose the preformed curve is offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches, 0.65 inches to 0.05 inches, or 0.55 inches to 0.15 inches. Corbett does, however, note that the shape of the device may include variations in sizes, shapes, proportions (par 0115) to established curves, angles, and shapes (pars 0106; figures 1, 3, 6). Therefore, the disclosure of Corbett encompasses a modification that includes the preformed curve offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches, 0.65 inches to 0.05 inches, or 0.55 inches to 0.15 inches as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Corbett to include the preformed curve offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches, 0.65 inches to 0.05 inches, or 0.55 inches to 0.15 inches, since such a modification would provide the predictable results of shaping modifications that facilitate insertion of the pump assembly into the body.
Regarding claims 7, 8, and 9, Corbett discloses the claimed invention including details about the shaping of the device (par 0106, 0115) as well as shape features for assisting with navigating the device through locations in the body such as the aortic arch (par 0103-0106). Corbett discloses the various curves and locations (par 0078, 0081, 0091) and modifications to the structure to fit the anatomy of the patient (par 0115), including as shown in figures 1, 3, and 6. Corbett, however, does not explicitly disclose an arc length in a range of 1.88 inches to 0.63 inches, 1.70 inches to 1.10 inches, or 1.60 inches to 1.20 inches. Corbett does, however, note that the shape of the device may include variations in sizes, shapes, proportions (par 0115) to established curves, angles, and shapes (pars 0106; figures 1, 3, 6). Therefore, the disclosure of Corbett encompasses a modification that includes an arc length in a range of 1.88 inches to 0.63 inches, 1.70 inches to 1.10 inches, or 1.60 inches to 1.20 inches as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Corbett to include an arc length in a range of 1.88 inches to 0.63 inches, 1.70 inches to 1.10 inches, or 1.60 inches to 1.20 inches, since such a modification would provide the predictable results of shaping modifications that facilitate insertion of the pump assembly into the body.
Regarding claims 12 and 13, Corbett discloses a percutaneous circulatory support device (par 0001-0002, 0005), comprising: an impeller portion (par 0078) comprising: a distal end portion (par 0078); a proximal end portion (par 0078); an impeller being rotatable to cause blood to flow through the percutaneous circulatory support device (pars 0001-0002, 0078); a cannula coupled to the distal end portion (par 0078); and a catheter coupled to the proximal end portion (par 0078, 0081, 0091), the catheter comprising a preformed curve having an arc length in a range of 1.88 inches to 0.63 inches and being offset from the proximal end portion by a distance in a range of 1.00 inches to 0.05 inches.
Corbett discloses the claimed invention including details about the shaping of the device (par 0106, 0115) as well as shape features for assisting with navigating the device through locations in the body such as the aortic arch (par 0103-0106). Corbett discloses the various curves and locations (par 0078, 0081, 0091) and modifications to the structure to fit the anatomy of the patient (par 0115), including as shown in figures 1, 3, and 6. Corbett, however, does not explicitly disclose the catheter comprising a preformed curve having an arc length in a range of 1.88 inches to 0.63 inches and being offset from the proximal end portion by a distance in a range of 1.00 inches to 0.05 inches, where the preformed curve comprises a radius in a range of 2.00 inches to 0.25 inches, or the preformed curve is offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches. Corbett does, however, note that the shape of the device may include variations in sizes, shapes, proportions (par 0115) to established curves, angles, and shapes (pars 0106; figures 1, 3, 6). Therefore, the disclosure of Corbett encompasses a modification that includes the catheter comprising a preformed curve having an arc length in a range of 1.88 inches to 0.63 inches and being offset from the proximal end portion by a distance in a range of 1.00 inches to 0.05 inches, where the preformed curve comprises a radius in a range of 2.00 inches to 0.25 inches, or the preformed curve is offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Corbett to include the catheter comprising a preformed curve having an arc length in a range of 1.88 inches to 0.63 inches and being offset from the proximal end portion by a distance in a range of 1.00 inches to 0.05 inches, where the preformed curve comprises a radius in a range of 2.00 inches to 0.25 inches, or the preformed curve is offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches, since such a modification would provide the predictable results of shaping modifications that facilitate insertion of the pump assembly into the body.
Regarding claim 14, Corbett discloses the preformed curve is a preformed catheter curve, and the cannula comprises a preformed cannula curve (par 0091).
Regarding claim 15, Corbett discloses the preformed catheter curve and the preformed cannula curve are disposed in a common plane (par 0091, 0106).
Regarding claim 18, Corbett discloses the claimed invention including details about the shaping of the device (par 0106, 0115) as well as shape features for assisting with navigating the device through locations in the body such as the aortic arch (par 0103-0106). Corbett discloses the various curves and locations (par 0078, 0081, 0091) and modifications to the structure to fit the anatomy of the patient (par 0115), including as shown in figures 1, 3, and 6. Corbett, however, does not explicitly disclose the preformed curve is offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches. Corbett does, however, note that the shape of the device may include variations in sizes, shapes, proportions (par 0115) to established curves, angles, and shapes (pars 0106; figures 1, 3, 6). Therefore, the disclosure of Corbett encompasses a modification that includes the preformed curve is offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches as known in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the features of Corbett to include the catheter comprising the preformed curve offset from the proximal end portion of the impeller portion by a distance in a range of 1.00 inches to 0.05 inches, since such a modification would provide the predictable results of shaping modifications that facilitate insertion of the pump assembly into the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lindsey G Wehrheim whose telephone number is (571)270-5181. The examiner can normally be reached Monday - Friday 9 a.m. - 5 p.m. EST.
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Lindsey G Wehrheim
Primary Examiner
Art Unit 3799
/LINDSEY G WEHRHEIM/Primary Examiner, Art Unit 3799
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