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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Consideration of factors under In re Wands, shows that an undue amount of experimentation would be required to make or use the invention based on the content of the disclosure. Examiner addresses only the salient Wands factors below for brevity, though other factors may also support the conclusion of non-enablement.
The level of one of ordinary skill and predictability in the art are considered high because the invention pertains to mechanics of materials and fluid dynamics which are inherently based on physical fundamental principles that are influenced by material properties.
However, the amount of direction and working examples provided by the inventor are minimal; disclosure recites “For some applications, the bands are bonded to the pump-outlet tube in such a manner that they cause the pump-outlet tube to assume a desired curvature upon being deployed inside the subject’s body,” and Fig. 31 is the only provided working example.
The quantity of experimentation needed to make the invention is considered high because of the various combinations of materials, dimensions, and configurations that are available.
Furthermore, the scope of the claimed invention is drawn to a genus of bands from a range of band species. Various band properties, configurations, orientations, and combinations thereof require a representative number of species to adequately describe the entire genus; See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
For at least these reasons, it is clear that one of ordinary skill in the art endeavoring to make and use the invention could not do so without undue experimentation, and the claims fail the enablement requirement of 35 USC 112(a).
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.
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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al (US Pre Grant Publication 2020/0237985), in view of Madrid et al (US Pre Grant Publication 2016/0206425).
Regarding claim 1, Tuval teaches an apparatus, comprising:
a left-ventricular assist device (20, Fig. 16A), comprising:
a collapsible pump-outlet tube (24, Fig. 1C and [0228] made of a collapsible material) configured for insertion, through an aorta of a subject, into a left ventricle of a heart of the subject such that the pump-outlet tube traverses an aortic valve of the subject (Tuval, [0220], Fig. 1B);
a frame (34, Fig. 1C) disposed at least partly within a distal portion of the pump-outlet tube and configured to hold the distal portion of the pump-outlet tube open (Tuval, [0227], Fig. 1C);
an impeller (50, Fig. 1C) disposed within the frame and configured to pump blood of the subject, through the pump-outlet tube, from the left ventricle into the aorta, thereby maintaining a proximal portion of the pump-outlet tube in an open state (Tuval, [0224]);
Tuval does not disclose one or more bands, each of which is bonded to an outer wall of the proximal portion of the pump-outlet tube, without extending around a full circumference of the pump-outlet tube, such that, while the proximal portion of the pump-outlet tube is maintained in the open state, the proximal portion of the pump-outlet tube curves at respective locations of the bands.
However, Madrid teaches a system comprising:
one or more bands (702, Fig. 32), each of which is bonded to an outer wall of the proximal portion of the pump-outlet tube (Madrid, [0178]), without extending around a full circumference of the pump-outlet tube, such that, while the proximal portion of the pump-outlet tube is maintained in the open state, the proximal portion of the pump-outlet tube curves at respective locations of the bands (Madrid, [0175-0179], Fig. 37); at least one strut (702) coupled to at least one outer balloon member (708) and attached to outer wall of proximal member (706) inside of catheter tube (711); plurality of struts along longitudinal direction and circumferentially-spaced with various configurations of struts and outer balloon member which include multiple struts supporting one outer balloon member and various expansion sequences that include outer balloon member expansion before strut expansion and vice versa; open state of catheter tube delivers fluid to outer balloon member which expands and curves around collapsed struts or maintains curved support provided by expanded struts (Fig. 32-37).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval with the one or more bands, each of which is bonded to an outer wall of the proximal portion of the pump-outlet tube, without extending around a full circumference of the pump-outlet tube, such that, while the proximal portion of the pump-outlet tube is maintained in the open state, the proximal portion of the pump-outlet tube curves at respective locations of the bands as taught by Madrid. One of ordinary skill in the art would have been motivated to make these modifications to prevent contact with the septal wall by guiding the distal tip element of the ventricular assist device toward the apex or free wall of the left ventricle (Tuval, [0380]).
Regarding claim 2, Tuval and Madrid teach the apparatus according to claim 1, but do not disclose wherein the bands are polymeric.
However, Madrid further teaches a system wherein the bands are polymeric [0175]; “Struts 702 can be formed of a variety of materials and in a variety of shapes, as long as the shape and structure is sufficiently strong to cause expansion of a prosthetic device, as described in more detail below. For example, each strut 702 can be formed of a tubular structure of elastic material, such as stiff plastic or metal.”
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein the bands are polymeric as further taught by Madrid. One of ordinary skill in the art would have been motivated to make these modifications to control strut properties such as elasticity and/or stiffness (Madrid, [0175]).
Regarding claim 3, Tuval and Madrid teach the apparatus according to claim 1, but do not disclose wherein a number of the bands is between 1 and 8.
However, Madrid further teaches a system wherein a number of the bands is between 1 and 8 ([0007], [0175], [0178], [0195], Fig. 5B); outer balloon comprises at least one strut; embodiments disclose expansion members with 1, 3, 7, and 8 balloon members.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein a number of the bands is between 1 and 8 as further taught by Madrid. In addition, the expansion members with 2, 5, and 6 struts are presumed obvious because they fall within the range of 1 and 8 struts as further taught by Madrid. One of ordinary skill in the art would have been motivated to make these modifications to prevent contact with the septal wall by guiding the distal-tip element of the ventricular assist device toward the apex or free wall of the left ventricle (Tuval, [0380]).
Regarding claim 4, Tuval and Madrid teach the apparatus according to claim 1, and Tuval further teaches a system wherein the left-ventricular assist device further comprises a blood-pressure-measurement tube (220, Fig. 16A) configured to extend to within the left ventricle from outside the subject [0343], and wherein the bands couple the blood-pressure-measurement tube to the outer wall of the proximal portion of the pump-outlet tube (24) ([0343], [0350]), but does not disclose bands that couple the blood-pressure-measurement tube to the outer wall of the proximal portion of the pump-outlet tube.
However, Madrid further teaches a system wherein the bands (452, Fig. 29) couple the blood-pressure-measurement tube to the outer wall of the proximal portion of the pump-outlet tube ([0168], [0178]); securing members (452) can be integrated with balloon member (450) as holding flaps or separate members that are coupled to balloon member (450) and prosthetic device (454);
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein the bands couple the blood-pressure-measurement tube to the outer wall of the proximal portion of the pump-outlet tube as further taught by Madrid. One of ordinary skill in the art would have been motivated to make these modifications to improve maneuverability of the pump-outlet tube by securing the blood-pressure-measurement tube to the outer wall of balloon member (Madrid, [0168]).
Regarding claim 5, Tuval and Madrid teach the apparatus according to claim 1, and Tuval teaches an apparatus wherein the left-ventricular assist device further comprises an optical fiber (272, Fig. 16E) configured to extend to within the left ventricle from outside the subject [0350], but does not disclose wherein the bands couple the optical fiber to the outer wall of the proximal portion of the pump-outlet tube.
However, Madrid further teaches a system wherein the bands (452, Fig. 29) couple the optical fiber to the outer wall of the proximal portion of the pump-outlet tube ([0168], [0178]); securing members (452) can be integrated with balloon member (450) as holding flaps or separate members that are coupled to balloon member (450) and prosthetic device (454);
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein the bands couple the optical fiber to the outer wall of the proximal portion of the pump-outlet tube as further taught by Madrid. One of ordinary skill in the art would have been motivated to make these modifications to improve maneuverability of the pump-outlet tube by securing the optical fiber to the outer wall of balloon member (Madrid, [0168]).
Regarding claim 6, Tuval and Madrid teach the apparatus according to claim 1, but do not disclose wherein each of the bands (702, Fig. 32) extends around 20-80% of the full circumference of the pump-outlet tube [0178].
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid with bands that extend around 20-80% of the full circumference of the pump-outlet tube because it is not inventive to discover the optimum or workable ranges through routine experimentation [In re Aller, 105 USPQ 233]. Furthermore, improving upon what is already generally known provides motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages [Peterson, 65 USPQ2d at 1382].
Regarding claim 7, Tuval and Madrid teach the apparatus according to claim 1, and Tuval further teaches a system wherein, by virtue of the proximal portion of the pump-outlet tube curving at the locations of the bands, the distal portion of the pump-outlet tube is configured to point toward an apex of the left ventricle while the pump-outlet tube traverses the aortic valve (Tuval, [0392], Fig. 25C); “Further typically, the curvature is such that when the proximal end of the tube is disposed within the aorta, at least a portion of the tube is disposed within the left ventricle and curving away from the septal wall of the left ventricle, toward the apex of the left ventricle and/or toward the free wall.”
Regarding claim 8, Tuval and Madrid teach the apparatus according to claim 1, and Tuval further teaches a system wherein, by virtue of the proximal portion of the pump-outlet tube curving at the locations of the bands, the distal portion of the pump-outlet tube is configured to point toward a free wall of the left ventricle while the pump-outlet tube traverses the aortic valve (Tuval, [0392], Fig. 25C); “Further typically, the curvature is such that when the proximal end of the tube is disposed within the aorta, at least a portion of the tube is disposed within the left ventricle and curving away from the septal wall of the left ventricle, toward the apex of the left ventricle and/or toward the free wall.”
Regarding claim 9, Tuval and Madrid teach the apparatus according to claim 1, but do not disclose wherein the bands are displaced from one other, along a length of the pump-outlet tube, by 1-5mm.
However, Madrid further teaches a system wherein the bands are displaced from one other, along a length of the pump-outlet tube, by 1-5mm (Madrid, [0203], Fig. 46).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein the bands are displaced from one other, along a length of the pump-outlet tube, by 1-5mm because it is not inventive to discover the optimum or workable ranges through routine experimentation [In re Aller, 105 USPQ 233]. Furthermore, improving upon what is already generally known provides motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages [Peterson, 65 USPQ2d at 1382].
Regarding claim 10, Tuval and Madrid teach the apparatus according to claim 1, but do not disclose wherein the left-ventricular assist device comprises two bands displaced circumferentially from one another.
However, Madrid further teaches a system wherein the left-ventricular assist device comprises two bands displaced circumferentially from one another ([0175], Fig. 32).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein the left-ventricular assist device comprises two bands displaced circumferentially from one another as further taught by Madrid. One of ordinary skill in the art would have been motivated to make these modifications to control the contact points of the expansion member by altering the structural displacements and thereby the shape of the expansion member (Madrid, [0175]).
Regarding claim 11, Tuval and Madrid teach the apparatus according to claim 10, but do not disclose a system wherein the bands are displaced circumferentially from one other by 20-120 degrees.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein the bands are displaced circumferentially from one other by 20-120 degrees because it is not inventive to discover the optimum or workable ranges through routine experimentation [In re Aller, 105 USPQ 233]. Furthermore, improving upon what is already generally known provides motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages [Peterson, 65 USPQ2d at 1382].
Regarding claim 12, Tuval and Madrid teach the apparatus according to claim 10, but do not disclose a system wherein the circumferential displacement of the bands is configured to cause the pump-outlet tube to twist.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein the circumferential displacement of the bands is configured to cause the pump-outlet tube to twist because it is not inventive to discover the optimum or workable ranges through routine experimentation [In re Aller, 105 USPQ 233]. Furthermore, improving upon what is already generally known provides motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages [Peterson, 65 USPQ2d at 1382].
Claim(s) 13 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al (US Pre Grant Publication 2020/0237985), in view of Madrid et al (US Pre Grant Publication 2016/0206425), and in further view of Danforth (US Patent No. 4,909,787).
Regarding claim 13, Tuval and Madrid teach the apparatus according to claim 1, but do not disclose wherein an axial spacing between adjacent bands is non-uniform along a length of the pump-outlet tube..
However, Danforth teaches a system wherein an axial spacing between adjacent bands is non-uniform along a length of the pump-outlet tube ([7:30-35], Fig. 6D); wedge of film (80) creates non-linear spacing along axial direction wherein the spacing is greater at the outer edge of heart pump tube.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval and Madrid wherein an axial spacing between adjacent bands is non-uniform along a length of the pump-outlet tube. as taught by Danforth. One of ordinary skill in the art would have been motivated to make these modifications to reduce coronary trauma during angioplasty by controlling tube flexibility (Danforth, [6:28-45]).
Regarding claim 14, Tuval, Madrid, and Danforth teach the apparatus according to claim 13, but do not disclose wherein the non-uniform axial spacing between the adjacent bands is configured to cause different regions of the pump-outlet tube to assume respective degrees of curvature.
However, Danforth further discloses a system wherein the non-uniform axial spacing between the adjacent bands is configured to cause different regions of the pump-outlet tube to assume respective degrees of curvature ([7:30-35], Fig. 6D); curvature of tube is greater toward inside of non-uniform band spacing.
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Tuval, Madrid, and Danforth wherein the non-uniform axial spacing between the adjacent bands is configured to cause different regions of the pump-outlet tube to assume respective degrees of curvature as further taught by Danforth. One of ordinary skill in the art would have been motivated to make these modifications to reduce coronary trauma during angioplasty by controlling tube flexibility (Danforth, [6:28-45]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWANE COLLARD whose telephone number is (571)272-6553. The examiner can normally be reached M-F 9 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ben Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DWANE COLLARD/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796