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
Applicant's arguments, filed 05/28/2026, with respect to the rejection of claims 1-18 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant contends that “Relocating the inflatable portion would fundamentally change its function … A modification as suggested by the Office Action would require substantial redesign of the device of Tuval and is not a simple substitution or predictable variation. Furthermore, Tuval specifically places the inflatable portion at the distal tip within the left ventricle, indicating that its function is tied to that location. This placement discourages relocating the inflatable portion to a proximal position near the outlet openings,” that “there is no teaching in Keren of a single expandable element positioned just proximally to outlet openings, as required by claim 1. Instead, Keren discloses two balloons positioned on opposite sides of the outlet region. The ballons are used to isolate a portion of the aorta, not to be located just proximal to the outlet openings (e.g., such that they can functionally operate with the outlets). … it would not have been obvious to combine Keren with Tuval at least because Keren's proximal balloon is part of a dual-balloon occlusion system that isolates a long aortic segment, which is incompatible with Tuval's continuous-flow ventricular assist device requiring unobstructed outflow, and provides no motivation to form a localized, non- occlusive element near the outlet openings,” that “Fierens does not describe a defined distance between the balloon and the outlets, or a spacing constraint of less than 30 mm between two distinct elements, as required by claim 1,” and that “The rejection over Tuval in view of Keren and Fierens is improper and based on impermissible hindsight. … Nothing in the cited art teaches or suggests relocating, redesigning, and combining these distinct features to arrive at a proximal expandable element within less than 30 mm of outlet openings in a left ventricular assist device, the significance of these limitation described above.” Examiner respectfully disagrees.
Firstly, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to Applicant’s argument that “Relocating the inflatable portion would fundamentally change its function … A modification as suggested by the Office Action would require substantial redesign of the device of Tuval and is not a simple substitution or predictable variation. Furthermore, Tuval specifically places the inflatable portion at the distal tip within the left ventricle, indicating that its function is tied to that location. This placement discourages relocating the inflatable portion to a proximal position near the outlet openings,” the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Here, under M.P.E.P. 2143(I)(G), it states that a conclusion of obviousness may be supported by “[s]ome teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.” There is motivation to combine the second embodiment of Tuval since it states that the structure prevents backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]) and since “It will be appreciated by persons skilled in the art that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof that are not in the prior art, which would occur to persons skilled in the art upon reading the foregoing description” (Tuval ¶[0593]). Consequently, it would have been obvious to incorporate the location of the inflatable portion with the primary embodiment of Tuval.
In response to Applicant’s argument that “there is no teaching in Keren of a single expandable element positioned just proximally to outlet openings, as required by claim 1. Instead, Keren discloses two balloons positioned on opposite sides of the outlet region. The ballons are used to isolate a portion of the aorta, not to be located just proximal to the outlet openings (e.g., such that they can functionally operate with the outlets). … it would not have been obvious to combine Keren with Tuval at least because Keren's proximal balloon is part of a dual-balloon occlusion system that isolates a long aortic segment, which is incompatible with Tuval's continuous-flow ventricular assist device requiring unobstructed outflow, and provides no motivation to form a localized, non- occlusive element near the outlet openings,” Examiner takes the position that Keren teaches the expandable element at least partially proximally to the blood-outlet openings as claimed. Under the broadest reasonable interpretation, the claim language of “an expandable element surrounding the delivery tube at least partially proximally to the blood-outlet openings” does not exclude multiple expandable elements such that Keren teaches an expandable element in the claimed location. Although Applicant contends that Keren does not teach a single expandable element, this single element is not apparent from the claim as currently written such that the aforementioned interpretation is reasonable. Additionally, in response to Applicant’s argument that there is no motivation to utilize Keren, such that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, it would have been obvious to one of ordinary skill in the art at the time of the invention to combine the teachings of Keren with the modified invention of Tuval in order to provide blood to the lower extremities (Keren ¶[0092]).
In response to Applicant’s argument that “Fierens does not describe a defined distance between the balloon and the outlets, or a spacing constraint of less than 30 mm between two distinct elements, as required by claim 1,” Examiner takes the position that under the broadest reasonable interpretation, Fierens teaches the claimed spacing constraint of less than 30 mm since the limitation is directed towards the length of the delivery tube, where Figure 9 of Fierens shows a delivery tube with defined spacing. The length of the tube between the balloon and the outlets is less than 30 mm since the length of the balloon is as little as 10 mm and the outlets are distributed along a length as little as 10 mm, where the total length is 20 mm. Consequently, this means that the space between the balloon and outlets will be less that the 30 mm as claimed and this limitation is implicitly taught by Fierens (See M.P.E.P. 2144(I), emphasis added, where “The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988); In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992); see also In re Kotzab, 217 F.3d 1365, 1370, 55 USPQ2d 1313, 1317 (Fed. Cir. 2000) (setting forth test for implicit teachings)).
In response to Applicant’s argument that “The rejection over Tuval in view of Keren and Fierens is improper and based on impermissible hindsight. … Nothing in the cited art teaches or suggests relocating, redesigning, and combining these distinct features to arrive at a proximal expandable element within less than 30 mm of outlet openings in a left ventricular assist device, the significance of these limitation described above,” such that Applicant takes the position that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
An “expandable element” in claim 1. For the purposes of examination, Examiner interprets that “an expandable element” refers to “an inflatable element … e.g., a balloon” as described in ¶[0469] of Applicant’s specification and in Claim 6 of Applicant’s disclosure.
An “inflatable element” in claim 6. For the purposes of examination, Examiner interprets that “an inflatable element” refers to “a balloon” as described in ¶[0469] of Applicant’s specification.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (hereinafter “Tuval”) (U.S. Pub. No. 2019/0209758 A1, IDS Reference No. 196 from IDS Dated 04/11/2024) in view of Keren et al. (hereinafter “Keren”) (U.S. Pub. No. 2004/0064090 A1, IDS Reference No. 9 from IDS Dated 04/11/2024) and Fierens et al. (hereinafter “Fierens”) (U.S. Pub. No. 2015/0018597 A1, IDS Reference No. 111 from IDS Dated 04/11/2024).
Regarding claim 1, Tuval teaches an apparatus (Abstract, where “Apparatus and methods are described including a blood pump configured to be placed inside a body of subject, the blood pump including an impeller that includes proximal and distal bushings, and a frame disposed around the impeller, the frame including proximal and distal bearings”), comprising:
a left-ventricular assist device (¶[0009], where a “ventricular assist device includes an impeller … ventricular assist device typically includes a tube, which traverses the subject's aortic valve, such that a proximal end of the tube is disposed in the subject's aorta and a distal end of the tube is disposed within the subject's left ventricle”), comprising:
a pump-outlet tube shaped to define one or more blood-outlet openings and configured for insertion, through an aorta of a subject, into a left ventricle of a heart of the subject such that the blood-outlet openings are disposed within the aorta and a distal portion of the pump-outlet tube is disposed within the left ventricle (¶[0359], where “a tube configured to traverse an aortic valve of a subject, such that a proximal portion of the tube is disposed within an aorta of the subject and a distal portion of the tube is disposed within a left ventricle of the subject, the tube defining one or more blood inlet openings within the distal portion of the tube, and one or more blood outlet openings within the proximal portion of the tube”);
an impeller disposed within the distal portion of the pump-outlet tube (¶[0009], where “the impeller, the axial shaft and the frame are disposed within a distal portion of the tube inside the subject's left ventricle”) and configured to pump blood of the subject proximally through the pump-outlet tube (¶[0009], where “Typically, the impeller is configured to pump blood from the left ventricle into the aorta by rotating … the proximal portion of the tube defines one or more blood outlet openings, via which blood flows from the tube into the ascending aorta, during operation of the impeller”);
a delivery tube configured to extend, from outside a body of a subject, through the pump-outlet tube to the distal portion of the pump-outlet tube (Figure 10A, second outer tube 142, ¶[0393],where “an outer tube disposed around the drive cable configured to extend from outside the subject's body to within the blood-pump tube, the outer tube defining first and second openings on a portion of the outer tube disposed within the blood-pump tube”); and
a drive cable (¶[0508], where “Reference is now made to FIGS. 10A, 10B, and 10C, which are schematic illustrations of drive cable 130 of ventricular assist device 20”) passing through the delivery tube (¶[0508], where “drive cable is typically disposed within a first outer tube 140 … the first outer tube is disposed within a second outer tube 142”) and configured to rotate the impeller (¶[0508], where “the rotational motion of the impeller (which is imparted via the axial shaft), as well as the axial back-and-forth motion of the axial shaft described hereinabove, is imparted to the axial shaft via the drive cable”).
The above-described embodiment of Tuval does not teach an expandable element surrounding the delivery tube at least partially proximally to the blood-outlet openings nor a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm.
A second embodiment of Tuval teaches an expandable element (¶[0563], where “the outer surface of the distal tip portion includes an inflatable portion 278 (e.g., a balloon), which is configured to be inflated when the distal tip portion is disposed inside the subject's left ventricle”) surrounding the delivery tube (Figure 21C, where the inflatable portion 278 surrounds a tube within delivery catheter 143, where Examiner interprets that said tube is outer tube 142 since outer tube 142 is disposed within the delivery catheter 143, ¶[0509], where “delivery catheter 143 … outer tube 142 is disposed inside the delivery catheter,” ¶[0563], where “an inflation lumen for inflating the inflatable portion is configured to pass through outer tube 142, and to then pass along the outer surface of tube 24, and to the inflatable portion of the distal tip portion”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches an expandable element surrounding the delivery tube, with the invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Neither embodiment of Tuval explicitly teaches an expandable element at least partially proximally to the blood-outlet openings nor a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm.
Keren teaches an apparatus for treating congestive heart by actively or passively enhancing perfusion to the renal arteries, where an embodiment comprises a specially configured balloon catheter and extracorporeal pump (Abstract), and further teaches an expandable element at least partially proximally to the blood-outlet openings (Figure 12, blood outlet 229, proximal balloon 215, where the balloon is proximal to the blood-outlet opening, ¶[0092], where “FIG. 12 better illustrates the inner workings of catheter 211 at the catheter distal end 214 … An additional blood outlet then may be provided proximal to proximal balloon 215, thereby providing blood to the lower extremities … screw pump 218 is causing high pressure blood to exit the blood outlet 229, the proximal balloon 215 and distal balloon 216 may be inflated”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches an expandable element at least partially proximally to the blood-outlet openings, with the modified invention of Tuval in order to provide blood to the lower extremities (Keren ¶[0092]).
Neither Tuval nor Keren teaches a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm.
Fierens teaches a medical treatment system (¶[0001]) with an inflatable balloon (¶[0145]), and further teaches a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm (Figure 9, distance J, distance L, ¶[0145], where “the outlets 62 allowing the perfusion and/or drainage are positioned at the distal end X of the balloon 59 of the device and the distance J at the distal end X and over which the outlets 62 are distributed is comprised between 10 and 14 mm … The balloon length L is comprised between 10 and 50 mm, preferably between 15 and 40 mm, more preferably between 20 and 30 mm, most preferably around 24 mm.” Examiner interprets that the length of the tube between the balloon and the outlets is less than 30 mm since the length of the balloon is as little as 10 mm and the outlets are distributed along a length as little as 10 mm, where the total length is 20 mm.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Fierens, which teaches a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm, with the modified invention of Tuval so that the device properly fits within the patient’s heart.
Regarding claim 2, Tuval in combination with Keren and Fierens teaches all limitations of claim 1 as described in the rejection above.
Keren teaches that the expandable element is configured to center the delivery tube within the aorta (¶[0024], where “the balloon material is chosen so that inflation of the balloon to a volume sufficient to occlude the aorta, i.e., to a diameter of between 15 and 35 mm, will create a sufficient pressure within the balloon so as to provide the balloon with some degree of mechanical rigidity and to likewise apply a small amount of outward radial force to the aortic wall so as to provide positional and orientational stability to the balloon.” Examiner interprets that since Tuval teaches a delivery tube within the center of expandable element as described above, and since the inflation of the expandable element occludes the aorta, that the delivery tube will be centered within the aorta, where the structure of Keren is capable of centering the delivery tube.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the expandable element is configured to center the delivery tube within the aorta, with the modified invention of Tuval in order to provide positional and orientational stability to the balloon (Keren ¶[0024]).
Regarding claim 3, Tuval in combination with Keren and Fierens teaches all limitations of claim 1 as described in the rejection above.
Tuval teaches that the pump-outlet tube comprises a cylindrical portion (¶[0462], where “tube 24 includes … a cylindrical central portion 44”), and wherein the cylindrical portion of the pump-outlet tube is shaped to define the blood-outlet openings, such that the blood-outlet openings are laterally facing (Figure 2C, where blood outlet openings 109 are laterally facing with respect to cylindrical central portion 44, ¶[0455], where “the proximal portion of the tube defines one or more blood outlet openings 109, via which blood flows from the tube into the ascending aorta, during operation of the impeller”).
Regarding claim 4, Tuval in combination with Keren and Fierens teaches all limitations of claim 1 as described in the rejection above.
Tuval teaches that the pump-outlet tube comprises: a narrower section, which comprises the distal portion of the pump-outlet tube (¶[0462], where “the tube extends to the end of distal conical portion 40 of frame 34. For such applications, the tube typically defines a distal conical portion 46, with the narrow end of the cone being distal with respect to the wide end of the cone, as shown in FIG. 2C”); and
a wider section, which is proximal to and wider than the narrower section (¶[0462], where “tube 24 includes … a cylindrical central portion 44 … the tube typically defines a distal conical portion 46, with the narrow end of the cone being distal with respect to the wide end of the cone, as shown in FIG. 2C … the central portion of the tube may widen from its proximal end to is distal end”), and which is shaped to define at least a portion of each of the blood-outlet openings such that a normal vector to the portion has a distally-facing component (Figure 2C, blood outlet openings 109, cylindrical central portion 44).
Regarding claim 5, Tuval in combination with Keren and Fierens teaches all limitations of claim 1 as described in the rejection above.
Keren teaches that the expandable element is entirely proximal to the pump-outlet tube (Figure 12, proximal balloon 215, housing 219, blood outlet 229, where the proximal balloon is entirely proximal to the pump-outlet tube since the proximal balloon is proximal to the blood outlet, which is a point of output for the housing and consequently a pump-outlet tube.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the expandable element is entirely proximal to the pump-outlet tube, with the modified invention of Tuval in order to provide blood to the lower extremities (Keren ¶[0092]).
Regarding claim 6, Tuval in combination with Keren and Fierens teaches all limitations of claim 1 as described in the rejection above.
A second embodiment of Tuval teaches that the expandable element comprises an inflatable element (¶[0563], where “the outer surface of the distal tip portion includes an inflatable portion 278 (e.g., a balloon), which is configured to be inflated when the distal tip portion is disposed inside the subject's left ventricle”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches that the expandable element comprises an inflatable element, with the modified invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Regarding claim 7, Tuval in combination with Keren and Fierens teaches all limitations of claim 6 as described in the rejection above.
None of the above-described embodiments of Tuval, Keren, nor Fierens explicitly teaches that the inflatable element, when inflated, is disposed at least partly within the pump-outlet tube.
A third embodiment of Tuval teaches that the inflatable element, when inflated, is disposed at least partly within the pump-outlet tube (Figure 28C, safety balloon 80, tube 312, where the safety balloon is at least partially within the tube, ¶[0582], where “Reference is now made to FIGS. 28A, 28B, and 28C, which are schematic illustrations of ventricular assist device 308, the device including a safety balloon 80 to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches that the inflatable element, when inflated, is disposed at least partly within the pump-outlet tube, with the modified invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Regarding claim 8, Tuval in combination with Keren and Fierens teaches all limitations of claim 7 as described in the rejection above.
A third embodiment of Tuval teaches that the inflatable element is disposed entirely within the pump-outlet tube (Figure 28C, safety balloon 80, tube 312, where the safety balloon is fully within the tube, ¶[0582], where “Reference is now made to FIGS. 28A, 28B, and 28C, which are schematic illustrations of ventricular assist device 308, the device including a safety balloon 80 to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches that the inflatable element is disposed entirely within the pump-outlet tube, with the modified invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions (Tuval ¶[0582]).
Regarding claim 9, Tuval in combination with Keren and Fierens teaches all limitations of claim 7 as described in the rejection above.
Keren teaches that the inflatable element is shaped to direct the blood through the blood-outlet openings (¶[0092], where “blood exits from the housing 219 through blood outlet 229 into the renal arteries 220 … An additional blood outlet then may be provided proximal to proximal balloon 215, thereby providing blood to the lower extremities … As screw pump 218 is causing high pressure blood to exit the blood outlet 229, the proximal balloon 215 and distal balloon 216 may be inflated. The balloons 215 and 216 may also be inflated prior to the screw pump 218 activation … The balloons 215 and 216 inflate against the aorta 210 to a final outer diameter indicated in phantom, thereby isolating the area surrounding the renal arteries 220. This allows the increased pressure caused by the pump to be most effective. Higher pressure blood will be more likely to enter the renal arteries 220, thereby effectively perfusing the constricted renal arteries 220.” Examiner interprets that the inflation of the proximal balloon directs blood through the blood outlet since the balloon increases pressure to perfuse blood.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the inflatable element is shaped to direct the blood through the blood-outlet openings, with the modified invention of Tuval in order to provide blood to the lower extremities and to increase pump effectiveness (Keren ¶[0092]).
Regarding claim 10, Tuval in combination with Keren and Fierens teaches all limitations of claim 9 as described in the rejection above.
Keren teaches that a distal end of the inflatable element has a width that decreases moving distally (Figure 12, proximal balloon 215, where the proximal balloon is widest at the center and narrows towards the ends, ¶[0092], where “The balloons 215 and 216 inflate against the aorta 210 to a final outer diameter indicated in phantom, thereby isolating the area surrounding the renal arteries 220”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that a distal end of the inflatable element has a width that decreases moving distally, with the modified invention of Tuval in order to have a final outer diameter that inflates against the aorta to isolate an area surrounding the renal arteries and to increase pump effectiveness (Keren ¶[0092]).
Regarding claim 11, Tuval in combination with Keren and Fierens teaches all limitations of claim 10 as described in the rejection above.
Keren teaches that the distal end of the inflatable element is frustoconical (Figure 12, proximal balloon 215, where the proximal balloon is widest at the center and narrows towards an end creating a frustoconical shape, ¶[0092], where “The balloons 215 and 216 inflate against the aorta 210 to a final outer diameter indicated in phantom, thereby isolating the area surrounding the renal arteries 220”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the distal end of the inflatable element is frustoconical, with the modified invention of Tuval in order to have a final outer diameter that inflates against the aorta to isolate an area surrounding the renal arteries and to increase pump effectiveness (Keren ¶[0092]).
Regarding claim 12, Tuval in combination with Keren and Fierens teaches all limitations of claim 6 as described in the rejection above.
A second embodiment of Tuval teaches that the expandable element, which is an inflatable element, surrounds the delivery tube and that an inflation lumen that inflates the delivery tube passes through the delivery tube to inflate the inflatable element (Figure 21C, where the inflatable portion 278 surrounds a tube within delivery catheter 143, where Examiner interprets that said tube is outer tube 142 since outer tube 142 is disposed within the delivery catheter 143, ¶[0509], where “delivery catheter 143 … outer tube 142 is disposed inside the delivery catheter,” ¶[0563], where “an inflation lumen for inflating the inflatable portion is configured to pass through outer tube 142, and to then pass along the outer surface of tube 24, and to the inflatable portion of the distal tip portion”) and that a wall of the delivery tube is shaped to define one or more openings, wherein the inflatable element surrounds the openings (¶[0563], where “an inflation lumen for inflating the inflatable portion is configured to pass through outer tube 142, and to then pass along the outer surface of tube 24, and to the inflatable portion of the distal tip portion.” Examiner interprets that the inflation lumen, which passes through the outer tube, will have at least one opening to inflate the inflatable element, and that since the inflation lumen passes through the outer tube, that the outer tube will have at least one opening to inflate the inflatable element as well. Additionally, the inflatable element will inherently surround the opening since it would not be adequately inflated otherwise.).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Tuval, which teaches that the expandable element, which is an inflatable element, surrounds the delivery tube and that an inflation lumen that inflates the delivery tube passes through the delivery tube to inflate the inflatable element and that a wall of the delivery tube is shaped to define one or more openings, with the invention of Tuval in order to prevent backflow of blood, for example, in the event that the impeller of the ventricular assist device malfunctions and to inflate the inflatable portion (Tuval ¶[0582]).
Keren teaches that the inflatable element surrounds the openings such that a fluid flowing, via the openings, from the delivery tube into the inflatable element inflates the inflatable element (Figure 12, proximal balloon 215, inflation lumen 230, ¶[0092], where “The inflation source 224 is activated, and an inflation fluid enters inflation lumen 230, which is in fluid communication with proximal balloon 215”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Keren, which teaches that the inflatable element surrounds the openings such that a fluid flowing, via the openings, from the delivery tube into the inflatable element inflates the inflatable element, with the modified invention of Tuval in order to inflate against the aorta to a final outer diameter indicated in phantom, thereby isolating the area surrounding the renal arteries, and to increase pressure caused by the pump, which increases pump effectiveness (Keren ¶[0092]).
Regarding claim 13, Tuval in combination with Keren and Fierens teaches all limitations of claim 12 as described in the rejection above.
Tuval teaches that the left-ventricular assist device further comprises: an axial shaft coupled to the impeller (¶[0009], where “a ventricular assist device includes an impeller disposed upon an axial shaft,” ¶[0468], where “an axial shaft 92 passes through the axis of impeller 50,” ¶[0508], where “the rotational motion of the impeller (which is imparted via the axial shaft), as well as the axial back-and-forth motion of the axial shaft described hereinabove, is imparted to the axial shaft via the drive cable”) and configured to rotate such that the impeller pumps the blood (¶[0009], where “the impeller is configured to pump blood from the left ventricle into the aorta by rotating,” ¶[0508], where “the rotational motion of the impeller (which is imparted via the axial shaft)”); and
at least one bearing configured not to rotate with the axial shaft (¶[0508], where “drive cable is typically disposed within a first outer tube 140, which is configured to remain stationary while the drive cable undergoes rotational and/or axial back-and-forth motion. The first outer tube is configured to effectively act as a bearing along the length of the drive cable”), and
wherein, distally to the openings, the fluid purges an interface between the axial shaft and the bearing (¶[0513], where “debris is generated by frictional forces between the drive cable and outer tube 140. Alternatively or additionally, a fluid (e.g., purging fluid) is disposed between the drive cable and the outer tube,” ¶[0523], where “Reference is now made to FIG. 13, which is a schematic illustration of a procedure for purging drive cable 130 of ventricular assist device 20 … proximal to proximal bearing 116, axial shaft 92 and cable 130 are surrounded by first and second outer tubes 140 and 142 … the purging fluid flows between drive cable 130, and first outer tube 140, as indicated by purging-fluid-flow arrow 148 in FIG. 13. In this manner, the interface between drive cable 130 (which rotates), and outer tube 140 (which remains stationary, during rotation of the drive cable) is purged. For some applications, some of the purging fluid additionally flows to the interface between the axial shaft and proximal bearing 116, thereby purging the interface”).
Regarding claim 14, Tuval in combination with Keren and Fierens teaches all limitations of claim 1 as described in the rejection above.
Tuval teaches that the pump-outlet tube is configured to curve proximally to the impeller (Figure 2C, tube 24, impeller 50, where the tube curves proximally to the impeller, ¶[0450], where “Reference is also made to FIGS. 2A, 2B, and 2C, which are schematic illustrations of a blood pump portion 27 of ventricular assist device 20, in accordance with some applications of the present invention. Typically, an impeller 50 is disposed within a distal portion 102 of tube 24 and is configured to pump blood from the left ventricle into the aorta by rotating”).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval, Keren, and Fierens as applied to claims 1 and 14 above, and further in view of Tuval et al. (hereinafter “Tuval ‘986”) (U.S. Pub. No. 2020/0237986 A1, IDS Reference No. 228 from IDS Dated 04/11/2024).
Regarding claim 15, Tuval in combination with Keren and Fierens teaches all limitations of claim 14 as described in the rejection above.
Tuval teaches that the pump-outlet tube is configured to curve by virtue of being pre-shaped (Figure 2C, tube 24, impeller 50, where the tube curves proximally to the impeller, ¶[0450], where “Reference is also made to FIGS. 2A, 2B, and 2C, which are schematic illustrations of a blood pump portion 27 of ventricular assist device 20, in accordance with some applications of the present invention. Typically, an impeller 50 is disposed within a distal portion 102 of tube 24 and is configured to pump blood from the left ventricle into the aorta by rotating.” Examiner takes the position that Tuval teaches the pump-outlet tube is configured to curve by virtue of being pre-shaped. Pre-shaping is functional language, where the structure of Tuval is configured to be curved by pre-shaping, and since the structure of Tuval is capable of performing the intended use, it meets the claim.).
However, should Applicant contend that the curvature does not refer to the curvature at the end of the pump-outlet tube, but that the pump-outlet tube curves as a whole, Tuval ‘986 teaches that the pump-outlet tube is configured to curve by virtue of being pre-shaped.
Tuval ‘986 teaches a ventricular assist device includes an impeller disposed upon an axial shaft (¶[0010]), and further teaches that the pump-outlet tube is configured to curve by virtue of being pre-shaped (¶[0391], where “tube 24 is pre-shaped such that, during operation of the impeller, when the pressure of the blood flow through the tube maintains the proximal portion of the tube in an open state, the tube is curved. 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 posterior wall of the left ventricle, toward the apex of the left ventricle and/or toward the free wall”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches that the pump-outlet tube is configured to curve by virtue of being pre-shaped, with the modified invention of Tuval in order to maintain the proximal portion of the tube in an open state (Tuval ‘986 ¶[0391]).
Regarding claim 16, Tuval in combination with Keren and Fierens teaches all limitations of claim 14 as described in the rejection above.
None of Tuval, Keren, nor Fierens teaches that the blood-outlet openings are arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings.
Tuval ‘986 teaches that the blood-outlet openings are arranged in a non-axisymmetric arrangement (¶[0395], where “For some applications, inlet openings 108 and/or outlet openings 109 are disposed in a non-axisymmetric configuration around tube 24”), and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings (¶[0389], where “Reference is now made to FIG. 25A, which is a schematic illustration of ventricular assist device 20, tube 24 of the device being configured to become curved when blood is pumped through the tube,” ¶[0395], where “Typically, tube 24 defines the inlet openings and/or the outlet openings at locations that are such as to cause tube 24 to become curved and/or such as to maintain the curvature of tube 24 as described with reference to FIGS. 25A-C … additionally, the blood outlet openings 109 may be disposed on the side of tube 24 that is at the inside of the curve of the tube (or on the inside of the desired curve of the tube). As blood exits the blood outlet openings the blood impacts the wall of the aorta, which causes the proximal end of tube 24 to be pushed in the opposite direction, in the direction of arrow 312”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches that the blood-outlet openings are arranged in a non-axisymmetric arrangement, wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-outlet openings, with the modified invention of Tuval in order to cause the tube to become curved and/or such as to maintain the curvature of tube (Tuval ‘986 ¶[0395]) and so that a separation is maintained between the blood inlet openings and posterior wall of the left ventricle, mitral valve leaflets, and/or subvalvular components of the mitral valve, such as chordae tendineae and/or papillary muscles (Tuval ‘986 ¶[0396]) .
Regarding claim 17, Tuval in combination with Keren and Fierens teaches all limitations of claim 14 as described in the rejection above.
None of Tuval, Keren, nor Fierens teaches that the pump-outlet tube is further shaped to define one or more blood-inlet openings arranged in a non-axisymmetric arrangement, and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings.
Tuval ‘986 teaches that the pump-outlet tube is further shaped to define one or more blood-inlet openings arranged in a non-axisymmetric arrangement (¶[0395], where “For some applications, inlet openings 108 and/or outlet openings 109 are disposed in a non-axisymmetric configuration around tube 24”), and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings (¶[0389], where “Reference is now made to FIG. 25A, which is a schematic illustration of ventricular assist device 20, tube 24 of the device being configured to become curved when blood is pumped through the tube,” ¶[0395], where “Typically, tube 24 defines the inlet openings and/or the outlet openings at locations that are such as to cause tube 24 to become curved and/or such as to maintain the curvature of tube 24 as described with reference to FIGS. 25A-C. For example, as shown, the blood inlet holes may be disposed on the side of tube 24 that is at the inside of the curve of the tube (or on the inside of the desired curve of the tube). As blood flows into the blood inlet opening, this lowers the pressure in the region above the blood inlet opening, and the distal end of tube 24 is then pulled toward this region (as indicated by arrow 310)”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches one or more blood-inlet openings arranged in a non-axisymmetric arrangement, wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the blood-inlet openings, with the modified invention of Tuval in order to cause the tube to become curved and/or such as to maintain the curvature of tube (Tuval ‘986 ¶[0395]) and so that a separation is maintained between the blood inlet openings and posterior wall of the left ventricle, mitral valve leaflets, and/or subvalvular components of the mitral valve, such as chordae tendineae and/or papillary muscles (Tuval ‘986 ¶[0396]) .
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval, Keren, and Fierens as applied to claims 1 and 14 above, and further in view of Tuval ‘986 and Mitze et al. (hereinafter “Mitze”) (U.S. Pub. No. 2022/0161018 A1).
Regarding claim 18, Tuval in combination with Keren and Fierens teaches all limitations of claim 14 as described in the rejection above.
None of Tuval, Keren, nor Fierens teaches that the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall.
Tuval ‘986 teaches that the left-ventricular assist device further comprises the pump-outlet tube that is configured to curve (¶[0389], where “Reference is now made to FIG. 25A, which is a schematic illustration of ventricular assist device 20, tube 24 of the device being configured to become curved when blood is pumped through the tube,” ¶[0391], where “tube 24 is pre-shaped such that, during operation of the impeller, when the pressure of the blood flow through the tube maintains the proximal portion of the tube in an open state, the tube is curved. 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 posterior wall of the left ventricle, toward the apex of the left ventricle and/or toward the free wall”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Tuval ‘986, which teaches that the pump-outlet tube is configured to curve, with the modified invention of Tuval in order to maintain the proximal portion of the tube in an open state (Tuval ‘986 ¶[0391]), to maintain the curvature of tube (Tuval ‘986 ¶[0395]), and so that a separation is maintained between the blood inlet openings and posterior wall of the left ventricle, mitral valve leaflets, and/or subvalvular components of the mitral valve, such as chordae tendineae and/or papillary muscles (Tuval ‘986 ¶[0396]).
None of Tuval, Keren, Fierens, nor Tuval ‘986 teaches that the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall.
Mitze teaches a mechanical circulatory support system for transcatheter delivery to the heart, where the device may comprise a tubular housing, an impeller and the guidewire aid (Abstract), and further teaches that the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube (Figure 7, tubular housing 61, pump inlets 66, pump outlets 68, inlet tube 70, ¶[0056], where “pump 22 include a tubular housing 61, which may include an inlet tube 70, a distal tip 64, and/or a motor housing 74. The tubular housing 61 may include one or more pump inlets 66 and/or outlets 68, which may be part of the inlet tube 70, or part of other structures such as an intermediate structure joining a proximal end of the inlet tube 70 to the motor housing 74,” ¶[0059], where “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.” Examiner interprets that the inlet tube has bands bonded to the outer wall based on the figure shown.), and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall (¶[0118], where “FIG. 23 is a perspective view of an alternative embodiment of an inlet tube 105b of an MCS system. The inlet tube 105b may be used with any of the pumps or MCS systems described herein,” ¶[0123], where “the inlet tube 105b may be bent in the direction of the first connection section 210b, the bend being shaped, for example, as an obtuse angle with respect to a longitudinal axis of the inlet tube 105b. The bend can be realized by heat treatment of the nitinol braid section 220b. Due to the shape-memory properties of the nitinol, the inlet tube 105b can be formed with a curve shape of the braid section 220b corresponding to the human anatomy in order to enable the inlet opening of the pump inlet 230b of the first connection section 210b to be positioned in the center of the heart chamber”).
It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Mitze, which teaches that the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube, and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall, with the modified invention of Tuval in order to form a curve shape corresponding to the human anatomy in order to enable the inlet opening of the pump inlet to be positioned in the center of the heart chamber (Mitze ¶[0123]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SEFRA D. MANOS/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792
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