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)(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.
(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 1-5 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C 102(a)(2) as being anticipated by Mitze et al. (hereinafter ‘Mitze’, U.S. PGPub No. 2022/0161021).
In regards to claim 1, Mitze discloses an apparatus, comprising: a blood pump, comprising: an axial shaft configured for insertion into, and rotation within, a body of a subject ([0007]: "The mechanical circulatory support systems, devices and methods may have one or more of any of the following features: a mechanical circulatory support system comprising a circulatory support catheter, comprising a circulatory support device carried by an elongate flexible catheter shaft, the circulatory support device comprising a tubular housing, a motor, an impeller configured to be rotated by the motor via a shaft, and an annular polymeric seal around the shaft..."), an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject ([0007]:"...the device actively unloads the left ventricle by pumping blood from the left ventricle into the ascending aorta and systemic circulation; the impeller is configured to be rotated by the motor via a shaft…"), a proximal radial bearing surrounding the axial shaft and configured to radially stabilize the axial shaft while the axial shaft rotates, a distal radial bearing surrounding the axial shaft distally from the proximal radial bearing and configured to radially stabilize the axial shaft while the axial shaft rotates ([0167]: "The locking mechanism 2641 may include projections extending radially outwardly that are received into corresponding grooves or recesses of the connector 2639. This engagement may rotationally stabilize the locking mechanism 2641 with respect to the connector 2639."), a proximal sleeve, which is less flexible than the axial shaft, disposed around the axial shaft such that the proximal sleeve contacts the proximal radial bearing as the axial shaft rotates ([0007]: "...the flexible section of the housing may include a flexible slotted tube covered by an outer polymeric sleeve…"), and a distal sleeve, which is less flexible than the axial shaft, disposed around the axial shaft distally from the proximal sleeve such that the distal sleeve contacts the distal radial bearing as the axial shaft rotates, wherein a ratio between a length of the axial shaft and a combined length of the proximal sleeve and distal sleeve is between 2:1 and 6:1 ([0007]: "...the tubular body of the insertion tool has a length within a range of from about 85 mm to about 160 mm... the tubular housing may have an axial length in a range of 60 mm to 100 mm…").
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In regards to claim 2, Mitze discloses a drive cable, wherein the axial shaft is coupled to the drive cable such that the axial shaft rotates with the drive cable (see Figs 9A and 9B, [0075]: "As shown, the impeller 72 may be attached to a short, rigid motor drive shaft 140. In the illustrated implementation, the drive shaft 140 extends distally into a proximally facing central lumen in the impeller 72, such as through a proximal extension 154 on the impeller hub 146, where it may be secured by a press fit, laser weld, adhesives or other bonding technique.").
In regards to claim 3, Mitze discloses a drive cable, wherein the axial shaft is a distal portion of the drive cable (see Figs 9A and 9B, [0075]: "As shown, the impeller 72 may be attached to a short, rigid motor drive shaft 140. In the illustrated implementation, the drive shaft 140 extends distally into a proximally facing central lumen in the impeller 72, such as through a proximal extension 154 on the impeller hub 146, where it may be secured by a press fit, laser weld, adhesives or other bonding technique.").
In regards to claim 4, Mitze discloses that the ratio is between 3:1 and 5:1 ([0007]: "...the tubular body of the insertion tool has a length within a range of from about 85 mm to about 160 mm... the tubular housing may have an axial length in a range of 60 mm to 100 mm…").
In regards to claim 5, Mitze discloses that a shaft length of the axial shaft is 30-50 mm, and wherein a sleeve length of the proximal sleeve and of the distal sleeve is 4-6 mm, such that the combined length is 8-12 mm ([0007]: "...the tubular body of the insertion tool has a length within a range of from about 85 mm to about 160 mm and an inside diameter within a range of from about 4.5 mm to about 6.5 mm...the tubular body of the insertion tool has a length within a range of from about 85 mm to about 160 mm... the tubular housing may have an axial length in a range of 60 mm to 100 mm…").
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.
Claims 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Mitze in view of Wang et al. (hereinafter ‘Wang’, U.S. PGPub No. 2005/0107870).
In regards to claims 6-7 and 9, Mitze discloses the invention substantially as described in claim 1 above.
However, Mitze does not disclose the proximal and distal sleeve being made of ceramic or zirconia nor the axial shaft being made of a metallic superalloy.
Wang teaches an implantable medical device which uses several different material compositions. Wang teaches uses ceramic materials ([0378]: "Thus, by way of illustration, one may use nonmagnetic materials such alumina, glass, gold-plated ceramic materials, and the like.") as well as zirconia ([0737]: "In the first step of the process preferably used to make this embodiment of the invention, (see step 40 of FIG. 1 of U.S. Pat. No. 6,713,671), conductive wires are coated with electrically insulative material. Suitable insulative materials include nano-sized silicon dioxide, aluminum oxide, cerium oxide, yttrium-stabilized zirconia, silicon carbide, silicon nitride, aluminum nitride, and the like."). Therefore, it would be obvious to one of ordinary skill in the art to use ceramic materials in an implantable device for their nonmagnetic properties ([1449]: "It is preferred that the giant magnetostrictive material is comprised of at least 80 weight percent of a ceramic material.", [1450]: "By way of illustration and not limitation, suitable ceramic materials that possess giant magnetostrictive properties are described in various U.S. patents."). Similarly, it would be obvious to one of ordinary skill in the art to use electrically insulative coatings ([0737]: "In the first step of the process preferably used to make this embodiment of the invention, (see step 40 of FIG. 1 of U.S. Pat. No. 6,713,671), conductive wires are coated with electrically insulative material. Suitable insulative materials include nano-sized silicon dioxide, aluminum oxide, cerium oxide, yttrium-stabilized zirconia, silicon carbide, silicon nitride, aluminum nitride, and the like.").
Additionally, Wang teaches using a superalloy for a primary material in an implantable device (see Wang, [0418]). Therefore, it would be obvious to one of ordinary skill in the art before the effective filing date of the blood pump axial shaft to use metallic materials, as doing so would provide a strong, magnetic material which can be used to drive an impeller or magnetic control system in an implantable device (such as the one described in Mitze) ([0419]: "Referring again to FIG. 3, one may charge to line 64 either one or more of these "binder material(s)" and/or the precursor(s) of these materials that, when subjected to the appropriate conditions in former 66, will form the desired mixture of nanomagnetic material and binder.").
In regards to claim 8, Mitze discloses that a part of the device is made of nitinol ([0065]: "The inlet tube 70 may comprise a highly flexible slotted (e.g., laser cut) metal (e.g., Nitinol) tube having a polymeric (e.g., Polyurethane) tubular layer to isolate the flow path."). It would be obvious to one of ordinary skill in the art to use nitinol, as doing so would provide a strong, magnetic material which can be used to drive an impeller or magnetic control system in an implantable device (such as the one described in Mitze) ([0419]: "Referring again to FIG. 3, one may charge to line 64 either one or more of these "binder material(s)" and/or the precursor(s) of these materials that, when subjected to the appropriate conditions in former 66, will form the desired mixture of nanomagnetic material and binder.").
Conclusion
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/B.M.L./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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