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 § 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 12, 13, and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Stevens et al (US 6,029,671, hereinafter “Stevens”).
Regarding claim 12, Stevens discloses a method for delivering a guidewire through a heart valve (as shown in figure 8), the method comprising: delivering a delivery catheter via a blood flow pathway to a heart valve (col 16, ln 54-col 17, ln 4; endoaortic partitioning device 10), the delivery catheter having a first inner lumen configured to receive an inner catheter, a positioning device, and a guidewire (col 16, ln 54-col 17, ln 4; where the endoaortic partitioning device 10 includes a lumen containing the mitral valvuloplasty catheter with a lumen to receive guidewire 518); passing the inner catheter through the first inner lumen of the delivery catheter (col 16, ln 54-col 17, ln 4; where the endoaortic partitioning device 10 includes a lumen containing the mitral valvuloplasty catheter with a lumen to receive guidewire 518, such that the inner catheter is passed through the inner lumen of the delivery catheter), the inner catheter having a second inner lumen and configured to carry the positioning device at an exterior surface of the inner catheter (col 16, ln 54-col 17, ln 4; where the dilatation balloon 512 is coupled to the outer surface of the mitral valvuloplasty catheter, the valvuloplasty catheter including an inner lumen that receives the guidewire); extending the inner catheter out of a distal end of the delivery catheter to allow the positioning device to expand in multiple directions around the inner catheter (col 16, ln 54-col 17, ln 4; as shown in figure 8, the dilatation balloon is not expanded within the endoaortic partitioning device but rather at the target location in the mitral valve after extending out of the partitioning device lumen, such that the inner catheter extends out of the delivery catheter and allows the balloon/positioning device to expand in multiple directions around the inner catheter as the positioning device is inflated); and passing the guidewire through the second inner lumen of the inner catheter and out of a distal end of the inner catheter (col 16, ln 54-col 17, ln 4; as shown in figure 8, the guidewire is passed through the second inner lumen of the inner catheter and out of a distal end of the inner catheter).
Regarding claim 13, Stevens discloses that the positioning device is configured to expand to position the inner catheter and guidewire above a central portion of the heart valve (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the dilatation balloon positions the inner catheter and guidewire above a central portion of the heart valve).
Regarding claim 14, Stevens discloses that the positioning device has a generally cylindrical shape with generally flat sides configured to extend along the blood flow pathway to prevent tilting of the positioning device (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the dilatation balloon is shown to be generally cylindrical with generally flat sides capable of preventing tilting of the positioning device).
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 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 1, 2, 3, 5, 6, 7, 11, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Richardson (US 2014/0031857 A1).
Regarding claim 1, Stevens discloses a system for delivering a guidewire through a heart valve (as shown in figure 8), the system comprising: a delivery catheter configured to pass through a blood flow pathway of a heart (col 16, ln 54-col 17, ln 4; endoaortic partitioning device 10); an inner catheter having an inner lumen (col 16, ln 54-col 17, ln 4; mitral valvuloplasty catheter with a lumen to receive guidewire 518); a guidewire configured to pass through the inner lumen of the inner catheter (col 16, ln 54-col 17, ln 4; mitral valvuloplasty catheter with a lumen to receive guidewire 518); and a positioning device coupled to an outer surface of the inner catheter (col 16, ln 54-col 17, ln 4; dilatation balloon 512 coupled to the outer surface of the mitral valvuloplasty catheter as shown in figure 8); wherein: the delivery catheter is configured to receive the inner catheter, guidewire, and positioning device (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the endoaortic partitioning device 10 receives the mitral valvuloplasty catheter, guidewire, and dilatation balloon); the delivery catheter is configured to prevent expansion of the positioning device (col 16, ln 54-col 17, ln 4; as shown in figure 8, the dilatation balloon is not expanded within the endoaortic partitioning device but rather at the target location in the mitral valve); and the positioning device is configured to expand upon removal from the delivery catheter (col 16, ln 54-col 17, ln 4; as shown in figure 8, the dilatation balloon is expanded within the target location in the mitral valve).
Stevens discloses the claimed invention (see rejection above), but does not explicitly disclose the positioning device is crimped to an outer surface of the inner catheter. Richardson is analogous art in regard to structures used during cardiovascular interventions and surgeries (abstract, par 0007). Richardson discloses it was known in the art to couple elements for intravascular applications using conventional means such as crimping (par 0018). Applied to the invention of Stevens, the features of Richardson would provide means to crimp the positioning device to an outer surface of the inner catheter of Stevens 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 provide the features of Richardson in the invention of Stevens, since such a modification would provide the predictable results of a conventional means to couple elements effectively that is able to withstand deployment in the heart of vasculature.
Regarding claim 2, Stevens discloses the positioning device is configured to conform to the blood flow pathway upon removal from the delivery catheter (col 16, ln 54-col 17, ln 4; as shown in figure 8, the dilatation balloon is expanded within the mitral valve to relieve a stenosis, such that the expanded balloon is inflated and presses on the mitral valve to relieve the stenosis).
Regarding claim 3, Stevens discloses the positioning device is configured to, upon removal from the delivery catheter, position the inner catheter and guidewire above a central portion of the heart valve (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the dilatation balloon positions the inner catheter and guidewire above a central portion of the heart valve).
Regarding claim 5, Stevens discloses the positioning device has a generally cylindrical shape with generally flat sides configured to extend along the blood flow pathway to prevent tilting of the positioning device (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the dilatation balloon is shown to be generally cylindrical with generally flat sides capable of preventing tilting of the positioning device).
Regarding claim 6, Stevens in view of Richardson as cited in the rejection of claim 1 above does not explicitly disclose the positioning device comprises: a base portion; one or more side portions extending from the base portion and around a hollow interior of the positioning device; and an opening across from the base portion and configured to be positioned near the heart valve to collect fragments displaced from the heart valve. Richardson is analogous art in regard to structures used during cardiovascular interventions and surgeries (abstract, par 0007). Richardson further discloses it was known in the art to provide a device for positioning and filtering (pars 0004, 0027), including a base portion (as shown in figure 5, the right portion of the conical element), one or more side portions extending from the base portion and around a hollow interior of the positioning device (par 0027, as shown in figure 5, where the side portions extend from the base portion on the right side to the left side near elements 40 and 42); and an opening across from the base portion (as shown in figure 5) and configured to be positioned near the heart valve to collect fragments displaced from the heart valve (par 0027). Applied to the invention of Stevens in view of Richardson above, the further features of Richardson would provide the positioning device comprising: a base portion; one or more side portions extending from the base portion and around a hollow interior of the positioning device; and an opening across from the base portion and configured to be positioned near the heart valve to collect fragments displaced from the heart valve 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 provide the further features of Richardson in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of effective diversion of debris, protecting downstream tissue from damage.
Regarding claim 7, Stevens discloses positioning device is configured to expand to a diameter that is less than a diameter of the blood flow pathway to allow the positioning device to move along the blood flow pathway after the positioning device expands (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the dilatation balloon is disclosed to be inflated such that during inflation the balloon would be allowed to move along the blood flow pathway after the positioning device expands).
Regarding claim 11, Stevens discloses the positioning device is configured to attach at multiple portions of the outer surface of the inner catheter (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the dilatation balloon extends along a length of the inner catheter/valvuloplasty catheter which Examiner interprets to read on attaching to a length (composed of multiple portions) of the outer surface of the inner catheter).
Regarding claim 15, Stevens discloses the claimed invention (see rejection of claim 12 above), but does not explicitly disclose the positioning device comprises: a base portion; one or more side portions extending from the base portion and around a hollow interior of the positioning device; and an opening across from the base portion and configured to be positioned near the heart valve to collect fragments displaced from the heart valve. Richardson is analogous art in regard to structures used during cardiovascular interventions and surgeries (abstract, par 0007). Richardson discloses it was known in the art to provide a device for positioning and filtering (pars 0004, 0027), including a base portion (as shown in figure 5, the right portion of the conical element), one or more side portions extending from the base portion and around a hollow interior of the positioning device (par 0027, as shown in figure 5, where the side portions extend from the base portion on the right side to the left side near elements 40 and 42); and an opening across from the base portion (as shown in figure 5) and configured to be positioned near the heart valve to collect fragments displaced from the heart valve (par 0027). Applied to the invention of Stevens, the features of Richardson would provide the positioning device comprising: a base portion; one or more side portions extending from the base portion and around a hollow interior of the positioning device; and an opening across from the base portion and configured to be positioned near the heart valve to collect fragments displaced from the heart valve 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 provide the features of Richardson in the invention of Stevens, since such a modification would provide the predictable results of effective diversion of debris, protecting downstream tissue from damage.
Regarding claim 17, Stevens discloses a device for positioning a guidewire at an opening of a heart valve (as shown in figure 8), the device comprising: an expandable base portion configured to compress to fit within a delivery catheter and expand within a blood flow pathway upon removal from the delivery catheter (col 16, ln 54-col 17, ln 4; as shown in figure 8, the dilatation balloon is expanded within the target location in the mitral valve); and one or more side portions configured to extend along tissue walls of the blood flow pathway to prevent tilting of the inner catheter (col 16, ln 54-col 17, ln 4; as shown in figure 8, where the dilatation balloon is shown with generally flat sides capable of preventing tilting of the inner catheter at least along the length of the balloon).
Stevens discloses the claimed invention (see rejection above), but does not explicitly disclose the positioning device is crimped to an outer surface of the inner catheter, thereby providing a crimped portion. Richardson is analogous art in regard to structures used during cardiovascular interventions and surgeries (abstract, par 0007). Richardson discloses it was known in the art to couple elements for intravascular applications using conventional means such as crimping (par 0018). Applied to the invention of Stevens, the features of Richardson would provide means to crimp the positioning device to an outer surface of the inner catheter, thereby providing a crimped portion of Stevens 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 provide the features of Richardson in the invention of Stevens, since such a modification would provide the predictable results of a conventional means to couple elements effectively that is able to withstand deployment in the heart of vasculature.
Claims 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Richardson, further in view of Salahieh et al (US 2005/0137696 A1, hereinafter “Salahieh”).
Regarding claim 4, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the positioning device at least partially comprising braided cords. Salahieh is analogous art in regard to structures known for use in cardiac surgery, such as heart valve replacement (abstract). Salahieh discloses it was known in the art to provide a positioning device that includes braided cords (pars 0032, 0041). Applied to the invention of Stevens in view of Richardson, the features of Salahieh would provide means for including braided cords in the positioning device 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 provide the features of Salahieh in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of protection for the patient from embolism during cardiac surgery as known in the art.
Regarding claim 18, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the expandable base portion is at least partially composed of braided cords. Salahieh is analogous art in regard to structures known for use in cardiac surgery, such as heart valve replacement (abstract). Salahieh discloses it was known in the art to provide a positioning device that includes braided cords (pars 0032, 0041). Applied to the invention of Stevens in view of Richardson, the features of Salahieh would provide means for including braided cords in the positioning device 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 provide the features of Salahieh in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of protection for the patient from embolism during cardiac surgery as known in the art.
Claims 8, 9, 10, 16, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens in view of Richards, further in view of Carpenter et al (US 2010/0179583 A1, hereinafter “Carpenter”).
Regarding claim 8, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the positioning device comprises one or more cords coiled about the inner catheter. Carpenter is analogous art in regard to known structures used during an endovascular procedure (abstract). Carpenter discloses it was known in the art to provide an emboli deflector further used as an anchored element in the circulatory system (pars 0077, 0127; figures 17A-C), including a positioning device comprising a positioning device comprising one or more cords coiled about a catheter (par 0077, 0127, figures 17A-C). Applied to the invention of Stevens in view of Richardson, the features of Carpenter would provide the positioning device comprising one or more cords coiled about the inner catheter 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 provide the features of Carpenter in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of known structures to prevent embolism during cardiovascular surgery.
Regarding claim 9, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the one or more cords are configured to increase in diameter at a base portion of the positioning device and maintain a maximal diameter at a side portion of the positioning device. Carpenter is analogous art in regard to known structures used during an endovascular procedure (abstract). Carpenter discloses it was known in the art to provide an emboli deflector further used as an anchored element in the circulatory system (pars 0077, 0127; figures 17A-C), including a positioning device comprising a cord that increases in diameter at a base portion of the positioning device and maintain a maximal diameter at a side portion of the positioning device (par 0127, figures 17A-C). Applied to the invention of Stevens in view of Richardson, the features of Carpenter would provide one or more cords configured to increase in diameter at a base portion of the positioning device and maintain a maximal diameter at a side portion of the positioning device 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 provide the features of Carpenter in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of known structures to prevent embolism during cardiovascular surgery.
Regarding claim 10, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 1 above), but does not explicitly disclose the positioning device comprises one or more flexible cords configured to curve away from the inner catheter and extend along the blood flow pathway. Carpenter is analogous art in regard to known structures used during an endovascular procedure (abstract). Carpenter discloses it was known in the art to provide an emboli deflector further used as an anchored element in the circulatory system (pars 0077, 0127; figures 17A-C), including a positioning device comprising a flexible cord that curves away from an inner elongated member and extends along a blood flow pathway when implanted (par 0077, 0127, figures 17A-C). Applied to the invention of Stevens in view of Richardson, the features of Carpenter would provide the positioning device comprising one or more flexible cords configured to curve away from the inner catheter and extend along the blood flow pathway 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 provide the features of Carpenter in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of known structures to prevent embolism during cardiovascular surgery.
Regarding claim 16, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 12 above), but does not explicitly disclose the positioning device comprises one or more cords coiled about the inner catheter. Carpenter is analogous art in regard to known structures used during an endovascular procedure (abstract). Carpenter discloses it was known in the art to provide an emboli deflector further used as an anchored element in the circulatory system (pars 0077, 0127; figures 17A-C), including a positioning device comprising a positioning device comprising one or more cords coiled about a catheter (par 0077, 0127, figures 17A-C). Applied to the invention of Stevens in view of Richardson, the features of Carpenter would provide the positioning device comprising one or more cords coiled about the inner catheter 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 provide the features of Carpenter in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of known structures to prevent embolism during cardiovascular surgery.
Regarding claim 19, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 17 above), but does not explicitly disclose the positioning device comprises one or more cords coiled about the inner catheter. Carpenter is analogous art in regard to known structures used during an endovascular procedure (abstract). Carpenter discloses it was known in the art to provide an emboli deflector further used as an anchored element in the circulatory system (pars 0077, 0127; figures 17A-C), including a positioning device comprising a positioning device comprising one or more cords coiled about a catheter (par 0077, 0127, figures 17A-C). Applied to the invention of Stevens in view of Richardson, the features of Carpenter would provide the positioning device comprising one or more cords coiled about the inner catheter 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 provide the features of Carpenter in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of known structures to prevent embolism during cardiovascular surgery.
Regarding claim 20, Stevens in view of Richardson discloses the claimed invention (see rejection of claim 17 above), but does not explicitly disclose the positioning device comprises one or more flexible cords configured to curve away from the inner catheter and extend along the blood flow pathway. Carpenter is analogous art in regard to known structures used during an endovascular procedure (abstract). Carpenter discloses it was known in the art to provide an emboli deflector further used as an anchored element in the circulatory system (pars 0077, 0127; figures 17A-C), including a positioning device comprising a flexible cord that curves away from an inner elongated member and extends along a blood flow pathway when implanted (par 0077, 0127, figures 17A-C). Applied to the invention of Stevens in view of Richardson, the features of Carpenter would provide the positioning device comprising one or more flexible cords configured to curve away from the inner catheter and extend along the blood flow pathway 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 provide the features of Carpenter in the invention of Stevens in view of Richardson, since such a modification would provide the predictable results of known structures to prevent embolism during cardiovascular surgery.
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 4/17/2026
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