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 .
Response to Arguments
A second non-final is being issued to apply a different prior art rejection to the claims.
Applicant’s arguments with respect to all claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein one of the steering wires is coupled to the frame by virtue of being coupled to the bearing housing.” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 20120059460 to Reitan (hereinafter Reitan).
Regarding Claim 1, an interpretation of Reitan discloses an apparatus, comprising:
a blood pump (abstract, Fig. 10-12) , comprising:
an axial shaft configured for insertion into, and rotation within, a body of a subject (drive shaft 4 figs. 1, 10-12, [0034]);
an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject (propeller 3 figs. 1, 10-12, [0034]); and
a frame surrounding the impeller (Cage 2 figs. 1, 10-12, [0034]); and
one or more steering wires coupled to the frame ([0033] including “attached”, [0049], Fig. 10-11; the thread/wire is attached to the sleeve at the base of the cage) and configured to extend from the frame, to outside the body of the subject, while the frame is within the body ([0033], [0049] including “is controlled from the outside and can therefore be used to determine the position of the pumphead 1 in the ascending aorta 11.”).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 1-3, 7-15, 17, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209751 to Tuval (hereinafter Tuval) in view of US 20200088207 to Schumacher et al. (hereinafter Schumacher).
Regarding Claim 1, an interpretation of Tuval discloses an apparatus, comprising:
a blood pump (abstract see also [0588]), comprising:
an axial shaft ([0464], Fig. 4 see also [0588]) configured for insertion into, and rotation within, a body of a subject ([0013], [0464], [0481], Fig. 4 see also [0588]; to the extent “for . . “ is reciting an intended use of the device the prior art device recited is functionally capable of performing the intended use);
an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject ([0013], [0459], [0464], [0481], Figs. 2A-B, 3A-4 see also [0588]; to the extent “for . . “ is reciting an intended use of the device the prior art device recited is functionally capable of performing the intended use); and
a frame surrounding the impeller ([0450]-[0451], [0464], [0481], Figs. 2A-B, 3A-4 see also [0588]; also referred to in the art as a scaffold, cage etc.).
an interpretation of Tuval may not explicitly disclose one or more steering wires coupled to the frame and configured to extend from the frame, to outside the body of the subject, while the frame is within the body.
However, in the same field of endeavor (medical devices), Schumacher teaches one or more steering wires coupled to the frame and configured to extend from the frame, to outside the body of the subject, while the frame is within the body ([0071] including “These cables 22, 23 can be secured at the proximal end outside the patient's body on a Manipulation ring which can be pushed and pulled from outside.”, Fig. 2; Fig. 2 shows the cable attached to the bearing frame).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulatting its positioning.
Regarding Claim 2, Yuval further discloses a drive cable ([0448], [0504], [0507], Figs. 7, 10A-C, 11C-E see also [0588]), wherein the axial shaft is coupled to the drive cable such that the axial shaft rotates with the drive cable ([0504], Figs. 10C, 11C-E see also [0588]).
Regarding Claim 3, an interpretation of Yuval further discloses a drive cable ([0448], [0504], [0507], Figs. 7, 10A-C, 11C-E see also [0588]), wherein the axial shaft is a distal portion of the drive cable ([0504], Figs. 10C, 11C-E see also [0588]).
Regarding Claim 7, an interpretation of Yuval may not explicitly disclose a handle comprising a steering control, wherein the steering wires are coupled to the steering control so as to be controllable via the steering control.
However, in the same field of endeavor (medical devices), Schumacher teaches a handle comprising a steering control, wherein the steering wires are coupled to the steering control so as to be controllable via the steering control ([0071] including “These cables 22, 23 can be secured at the proximal end outside the patient's body on a Manipulation ring which can be pushed and pulled from outside.”, Fig. 2; cage/frame is attached to bearing frame element which the cables are also attached pull adjust one cable relative to the other and it “steers” the device).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Regarding Claim 8, an interpretation of Yuval further discloses a radial bearing ([0464], [0478] see also [0588]), configured to radially stabilize the axial shaft while the axial shaft rotates ([0464], [0478] see also [0588]; to the extent “to . . .” is reciting an intended use of the device the prior art device recited is functionally capable of performing the intended use); and
a bearing housing that houses the radial bearing and is coupled to the frame ([0464], [0478], Fig 5A see also [0588]; outer enclosure of the bearing(s) see Figs. 5A-B),
An interpretation of Yuval may not explicitly disclose wherein one of the steering wires is coupled to the frame by virtue of being coupled to the bearing housing.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein one of the steering wires is coupled to the frame by virtue of being coupled to the bearing housing ([0071], Fig. 2; per fig. 2 cage/frame is attached to bearing frame element which the cables are also attached pull adjust one cable relative to the other and it “steers” the device).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulatting its positioning.
Regarding Claim 9, an interpretation of Yuval may not explicitly disclose wherein the steering wires are configured for orienting the frame.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein the steering wires are configured for orienting the frame ([0071], Fig. 2; cage/frame is attached to bearing frame element which the cables are also attached pull adjust one cable relative to the other and it “steers” the device).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulatting its positioning.
Regarding Claim 10, an interpretation of Yuval further discloses placement of the pump in the left ventricle of a heart ([0445], [0483]-[0484] see also [0588])
An interpretation of Yuval may not explicitly disclose wherein the steering wires are configured to extend from the frame while the frame is within a left ventricle of a heart of the subject, and wherein the steering wires are configured for orienting the frame within the left ventricle.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein the steering wires are configured to extend from the frame while the frame is within a left ventricle of a heart of the subject ([0070]-[0071], Fig. 2; to the extent “to . . . “ is reciting an intended use of the device the prior art device recited is functionally capable of performing the intended use), and wherein the steering wires are configured for orienting the frame within the left ventricle ([0071], Fig. 2; cage/frame is attached to bearing frame element which the cables are also attached pull adjust one cable relative to the other and it “steers” the device. to the extent “for . . .” is reciting an intended use of the device the prior art device recited is functionally capable of performing the intended use).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Regarding Claim 11, an interpretation of Yuval may not explicitly disclose wherein one of the steering wires is coupled to a proximal end of the frame.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein one of the steering wires is coupled to a proximal end of the frame ([0071], Fig. 2; cage/frame is attached to bearing frame element which the cables are also attached pull adjust one cable relative to the other and it “steers” the device).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Regarding Claim 12, an interpretation of Yuval may not explicitly disclose wherein another one of the steering wires is coupled to a distal end of the frame.
However, in the same field of endeavor (medical device), Schumacher teaches wherein another one of the steering wires is coupled to a distal end of the frame ([0071], Fig. 2; cage/frame is attached to bearing frame element which the cables are also attached pull adjust one cable relative to the other and it “steers” the device).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Yuval in view of Schumacher discloses the claimed invention except for the steering wires attached to the distal end. It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to rearrange the positioning of attachment of a cable to the distal end of the pump, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. (see MPEP 2144.04(VI)). Applicants do not recite a criticality for the positioning the steering wires and recite the steering wires can be mounted in multiple positions.
Regarding Claim 13, an interpretation of Tuval further discloses a delivery tube coupled to the frame and configured to extend from the frame, to outside the body of the subject, while the frame is within the body ([0390], [0504]-[0505] including “second outer tube”, [0535], Fig. 13 see also [0518], [0588]),
an interpretation of Tuval may not explicitly disclose wherein the steering wires pass through the delivery tube.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein the steering wires pass guided by the catheter ([0071], Fig. 2; the cables run through the outer tube).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame, and a first and a second outer tube etc. as disclosed by Tuval to include cables attached to the bearing and frame element which extends externally to outside the person as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Yuval in view of Schumacher discloses the claimed invention except for the steering wires through within the first outer tubes (aka delivery tube). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to rearrange the positioning of steering wires to be within the first outer tube, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. (see MPEP 2144.04(VI)). Applicants do not recite a criticality for the positioning the steering wires being positioned between the delivery and drive-cable- bearing tube.
Regarding Claim 14, an interpretation of Yuval further discloses a drive-cable- bearing tube coupled to the frame and configured to extend from the frame, to outside the body of the subject, within the delivery tube ([0504] including “first outer tube”, [0517], Figs. 5A13 see also [0588]),
Tuval discloses a delivery tube which runs through lumen of a delivery catheter and has a first outer tube inside the delivery tube, an interpretation of Yuval may not explicitly disclose wherein the steering wires are disposed between the drive-cable-bearing tube and the delivery tube.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein the steering wires pass through the delivery tube.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein the steering wires pass guided by the catheter ([0071], Fig. 2; the cables run through the outer tube).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame, and a first and a second outer tube etc. as disclosed by Tuval to include cables attached to the bearing and frame element which extends externally to outside the person as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Yuval in view of Schumacher discloses the claimed invention except for the steering wires through between the first and second outer tubes (aka delivery and drive-cable- bearing tube). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to rearrange the positioning of steering wires to be between the first and second outer tubes, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. (see MPEP 2144.04(VI)). Applicants do not recite a criticality for the positioning the steering wires being positioned between the delivery and drive-cable- bearing tube.
Regarding Claim 15, an interpretation of Tuval discloses a method, comprising:
inserting a blood pump into a body of a subject ([0445]-[0446], Fig. 1B see also [0588]), the blood pump including:
an axial shaft ([0464], Fig. 4 see also [0588]), an impeller coupled to the axial shaft ([0013], [0464], [0481], Fig. 4 see also [0588]), and a frame surrounding the impeller ([0450]-[0451], [0464], [0481], Figs. 2A-B, 3A-4 see also [0588]; also referred to in the art as a scaffold, cage etc.);
subsequently to orienting the frame, rotating the impeller such that the impeller pumps blood of the subject ([0013], [0445]-[0446], [0459], [0464], [0481], Figs. 1B, 2A-B, 3A-4 see also [0588]).
an interpretation of Tuval may not explicitly disclose using one or more steering wires coupled to the frame and extending from the frame to outside the body of the subject, orienting the frame.
However, in the same field of endeavor (medical devices), Schumacher teaches one or more using one or more steering wires coupled to the frame and extending from the frame to outside the body of the subject, orienting the frame ([0071] including “These cables 22, 23 can be secured at the proximal end outside the patient's body on a Manipulation ring which can be pushed and pulled from outside.”, Fig. 2; Fig. 2 shows the cable attached to the bearing frame).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Regarding Claim 17, an interpretation of Tuval further discloses wherein inserting the blood pump comprises inserting the blood pump into a left ventricle of the subject ([0445], [0483]-[0484] see also [0588]).
Regarding Claim 19, an interpretation of Tuval may not explicitly disclose one of the steering wires is coupled to a proximal end of the frame.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein one of the steering wires is coupled to a proximal end of the frame ([0071], Fig. 2; cage/frame is attached to bearing frame element which the cables are also attached pull adjust one cable relative to the other and it “steers” the device).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
Claim Rejections - 35 USC § 103
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuvel in view of Schumacher in further view of US 20180263773 to Poppe et al. (hereinafter Poppe).
Regarding Claim 4, an interpretation of Tuval may not explicitly disclose wherein the steering wires comprise respective elongation-resistant fibers.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein the steering wires ([0071] including “These cables 22, 23 can be secured at the proximal end outside the patient's body on a Manipulation ring which can be pushed and pulled from outside.”, Fig. 2; Fig. 2 shows the cable attached to the bearing frame).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulating its positioning.
An interpretation of Tuval in view of Schumacher may not explicitly disclose the wires are elongation-resistant fibers.
However, in the same field of endeavor (medical devices), Poppe teaches a variety of wire and cables known in the VAD art including aramid ([0081] including “an axial wire made from a suitable polymer or metal (e.g., aramid)”; aramid is a elongation-resistant fiber).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval in view of Schumacher to include the wire is more specifically a aramid fiber because this is merely the simple substitution of one known element (pull cable Schuaker) for another (aramid fiber of Poppe) to obtain predictable results.
Regarding Claim 5, an interpretation of Tuval may not explicitly disclose wherein the steering wires comprise respective aramid fibers.
However, in the same field of endeavor (medical devices), Schumacher teaches wherein the steering wires ([0071] including “These cables 22, 23 can be secured at the proximal end outside the patient's body on a Manipulation ring which can be pushed and pulled from outside.”, Fig. 2; Fig. 2 shows the cable attached to the bearing frame).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval to include cables attached to the bearing and frame element as recited by Schumacher because it is combining the known prior art elements as disclosed by Tuval with those disclosed by Schumacher according to known method to yield the predictable results of having a wired connection to the bearing frame for manipulatting its positioning.
An interpretation of Tuval in view of Schumacher may not explicitly disclose the wires are aramid fibers.
However, in the same field of endeavor (medical devices), Poppe teaches a variety of wire and cables known in the VAD art including aramid fibers ([0081] including “an axial wire made from a suitable polymer or metal (e.g., aramid)”; aramid is a elongation-resistant fiber).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the percutaneous VAD with pump elements including the frame etc. as disclosed by Tuval in view of Schumacher to include the wire is more specifically a aramid fiber because this is merely the simple substitution of one known element (pull cable Schuaker) for another (aramid fiber of Poppe) to obtain predictable results.
Allowable Subject Matter
Claim 6, 16, 18, 20-21 are allowable over the prior art. Claims 6, 16, 18, 20-21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20200030511 see [0036]-[0041], Figs 5-6
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/James Moss/Examiner, Art Unit 3792
