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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-18) in the reply filed on 03/16/2026 is acknowledged.
Claims 19-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/16/2023.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 5, the claim recites, “wherein the flexural rigidity at a third portion of the delivery tube, which is configured to pass through at least a portion of an aortic arch of the subject, is between the flexural rigidity at the first portion of the delivery tube and the flexural rigidity at the second portion of the delivery tube.” However, claim 1 recites, “a third portion of the delivery tube” (line 12), and that a third portion of the delivery tube has a rigidity greater than a first and second portion of the delivery tube. It is unclear if “a third portion of the delivery tube” from line 1 of claim 5 is the same “a third portion of the delivery tube” from line 12 of claim 1. If they are the same, the recitation that the third portion of the delivery tube has a flexural rigidity between that of the first and second portion, contradicts the recitation in claim 1, which says the first portion has a flexural rigidity less than the second portion, and the second portion has a flexural rigidity less than the third portion (effectively claiming that the third portion has the greatest flexural rigidity, and therefore cannot have a flexural rigidity between the first and second portion).
Claim Rejections - 35 USC § 102
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 1, 5-7, and 9-11 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Keenan et al. (US 11077294 B2, "Keenan").
Regarding claim 1, Keenan teaches an apparatus (catheter pump 10 (Fig. 1)), comprising: a left-ventricular assist device (Fig. 3; impeller assembly 92; para. (25): "FIG. 3 illustrates one use of the catheter pump 10. A distal portion of the pump 10 is placed in the left ventricle LV of the heart to pump blood from the LV into the aorta."), comprising: an impeller (Fig. 4; 112) configured for insertion into a left ventricle of a heart of a subject (Fig. 3; para. (25): "A distal portion of the pump 10 is placed in the left ventricle LV of the heart to pump blood from the LV into the aorta."); a delivery tube (catheter body 104; Fig. 4-6) configured to pass, through an aorta of the subject (Fig. 3; impeller assembly 92), from outside the subject into the left ventricle (para. (4): "A rotary blood pump is typically inserted into the body and connected to the cardiovascular system, for example, to the left ventricle and the ascending aorta to assist the pumping function of the heart"), the delivery tube comprising a braid (para. (42): "In addition to the foregoing structures for varying the stiffness along the length of the catheter body 104, a separate stiffening component, such as a braid 188, can be disposed in the catheter body 104, 104A."; para. (43): " As discussed above, the catheter assembly 100 preferably also includes an outer sheath or sheath assembly 88 provided over the elongate body 104, 104A to aid in delivering, deploying and/or removing the impeller 112."; Fig. 6A-D) having a pick density that varies along a length of the delivery tube (para. (51): "A braided structure 157 can be provided along at least a portion of the length of the sheath assembly 88′ to provide reinforced mechanical strength, e.g., improved longitudinal or axial strength and improved radial strength. In one embodiment a stiffness contribution by the braided structure 157 varies along the length of the sheath assembly 88′, for example providing a denser braid in the proximal portion 153A than in portions of the sheath assembly 88′ distal the proximal portion 153A."; para. (53): "The second portion 153B can be configured with less stiffness than the proximal portion 153A. The second portion 153B can have a portion of the braided structure 157 that is less stiff, e.g., lower braid density, than the portion of the braided structure 157 in the proximal portion 153A."), such that a flexural rigidity of the delivery tube at a first portion of the delivery tube (para. (6): "When the sheath assembly is in the impeller assembly deployment position, a reduction in stiffness is provided between the distal end of the sheath assembly and the impeller assembly."), which is configured to traverse an aortic valve of the subject, is less than the flexural rigidity at a second portion of the delivery tube, which is configured to traverse at least a portion of an aortic arch of the subject, and the flexural rigidity at the second portion is less than the flexural rigidity at a third portion of the delivery tube, which is configured to traverse a descending aorta of the subject (para. (53) mentions the portions of the sheath assembly 88', and where the position markers decrease in stiffness: "The second portion 153B can be configured with less stiffness than the proximal portion 153A. The second portion 153B can have a portion of the braided structure 157 that is less stiff, e.g., lower braid density, than the portion of the braided structure 157 in the proximal portion 153A… A third portion 153C disposed distal the second portion 153B can have a lesser stiffness than in the second portion 153B." ; Para. (53) also discloses that the braid density is varied to achieve the change in stiffness. Additionally, given that the braid rigidity is a matter of varying the braid density, and the delivery tube and braid of Keenan discloses varying the braid density to change the stiffness of delivery tube portions, then, absent evidence of the contrary, each portion of the sheath (153A, 153B, and 153C) would have enough flexibility to be able to traverse their respective anatomical structures (the descending aorta, aortic arch, and aortic valve). Since the device of Keenan is also concerned with left ventricular assist, the portions of the aorta that the delivery tube needs to traverse would be the same as that of the instant application); and a drive cable (drive shaft 144; Fig. 6), which passes through the delivery tube (para. (32): "The drive shaft 144 extends proximally within the catheter body 104 from the impeller 112.") and is configured to rotate the impeller so as to pump blood of the subject from the left ventricle into the aorta (para. (32): "The drive shaft 144 couples with the motor at the proximal end and with the impeller 112 at the distal end thereof. The drive shaft 144 can be formed with any suitable structure, but should be sufficient flexible to traverse at least from a peripheral (e.g., femoral) artery to a heart chamber, such as the left ventricle, as well as sufficiently durable to rotate at a high speed for several hours, for several days, and in some cases, months."; the drive shaft is coupled with the motor to rotate the impeller and assist with pumping blood to the aorta from the left ventricle.).
Regarding claim 5, Keenan teaches the apparatus according to claim 1 (see above), wherein the flexural rigidity at a third portion of the delivery tube, which is configured to pass through at least a portion of an aortic arch of the subject, is between the flexural rigidity at the first portion of the delivery tube and the flexural rigidity at the second portion of the delivery tube. (para. (53) mentions the portions of the sheath assembly 88', and where the position markers decrease in stiffness: "The second portion 153B can be configured with less stiffness than the proximal portion 153A. The second portion 153B can have a portion of the braided structure 157 that is less stiff, e.g., lower braid density, than the portion of the braided structure 157 in the proximal portion 153A… A third portion 153C disposed distal the second portion 153B can have a lesser stiffness than in the second portion 153B." ; Para. (53) also discloses that the braid density is varied to achieve the change in stiffness. Additionally, given that the braid rigidity is a matter of varying the braid density, and the delivery tube and braid of Keenan discloses varying the braid density to change the stiffness of delivery tube portions, then, absent evidence of the contrary, each portion of the sheath (153A, 153B, and 153C) would have enough flexibility to be able to traverse their respective anatomical structures (the descending aorta, aortic arch, and aortic valve). Since the device of Keenan is also concerned with left ventricular assist, the portions of the aorta that the delivery tube needs to traverse would be the same as that of the instant application). Additionally, the any portion of the delivery tube could be considered the “third portion” (as well as the “first portion” and “second portion.” It is merely a matter of labeling the tube. Since Keenan discloses portions with varying rigidities that are used for LVAD delivery, the portion passing through the aortic arch could be considered the “third portion.”).
Regarding claim 6, Keenan teaches the apparatus according to claim 1 (see above), wherein the delivery tube comprises a uniform inner surface. (para. (33): " In one embodiment, the catheter body 104 has an inner layer 148 surrounding the lumen 140 that comprises high density polyethylene (HDPE). For example, Marlex 4903 HDPE can be disposed about the lumen 140. If a composite structure is used to form the catheter body 104, the inner layer 148 has a thickness that is sufficient to withstand wear caused by interaction with the drive shaft 144, which can be rotated at a very high speed in some applications, for example from 20,000-40,000 revolutions per minute. The inner layer can have a thickness of 0.003 inches." Keenan discloses that the thickness is 0.003 inches and is the same material; Therefore, it is uniform.).
Regarding claim 7, Keenan teaches the apparatus according to claim 1 (see above), wherein the flexural rigidity at a distal end of the delivery tube is greater than the flexural rigidity at the first portion of the delivery tube (para. (40): "For example, in one embodiment, the catheter body 104 is stiffest near the distal end where the catheter body 104 is joined to the working end."; “[S]tiffest” implies the distal end is stiffer than the first portion ).
Regarding claim 9, Keenan teaches the apparatus according to claim 7 (see above), wherein the flexural rigidity at the distal end of the delivery tube is between the flexural rigidity at the first portion of the delivery tube and the flexural rigidity at the third portion of the delivery tube (para. (53) mentions the portions of the sheath assembly 88', and where the position markers decrease in stiffness: "The second portion 153B can be configured with less stiffness than the proximal portion 153A. The second portion 153B can have a portion of the braided structure 157 that is less stiff, e.g., lower braid density, than the portion of the braided structure 157 in the proximal portion 153A… A third portion 153C disposed distal the second portion 153B can have a lesser stiffness than in the second portion 153B." ; Para. (53) also discloses that the braid density is varied to achieve the change in stiffness. Additionally, the labeling of “the distal end” is broad enough to be considered any section of the tubing. As necessitated by claim 1, the first portion of the delivery tube has a flexural rigidity less than the second portion, which has less flexural rigidity than the third portion (order of flexural rigidity: 1<2<3). As necessitated by claim 7, the flexural rigidity of the distal end of the delivery tube is greater than that of the first portion (Distal > 1). And, as necessitated claim 9, the distal end’s flexural rigidity is between the 1 and 3 (1<D<3). Given it’s broadest reasonable interpretation, since Keenan disclose a second portion (153B) with a flexural rigidity between the first (153A) and third (153C), the second portion (153B) could be considered as the distal portion, which has flexural rigidity between the first and third portions. Therefore, claim 9 is anticipated by Keenan.
Regarding claim 10, Keenan teaches the apparatus according to claim 1 (see above), wherein the flexural rigidity at a fourth portion of the delivery tube, which is configured to span a point of insertion into a body of the subject, is less than the flexural rigidity at the third portion. (para. (53): "The fourth portion 153D can have any suitable configuration. In one embodiment, the fourth portion 153D is stiffer than the third portion 153C."; Absent evidence of the contrary, and since the stiffness is variable, 153D could span a point of insertion into a body. It is merely a matter of defining which portion of the tube is the fourth portion.).
Regarding claim 11, Keenan teaches the apparatus according to claim 10 (see above), wherein the flexural rigidity at a proximal end of the delivery tube is greater than the flexural rigidity at the fourth portion (para. (53): “A fourth portion 153D can correspond to the marker 155A. The fourth portion 153D can have any suitable configuration. In one embodiment, the fourth portion 153D is stiffer than the third portion 153C. In one embodiment, the fourth portion 153D has the same stiffness as the second portion 153B.” The proximal end is the end closest to 153A; It is disclosed that 153D has the same stiffness as 153B, which is disclosed in para. (53) as being less stiff than 153A).
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.
Claims 2-4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 11077294 B2, "Keenan"), in view of Colgan et al. (US 6520983 B1, "Colgan").
Regarding claim 2, Keenan teaches the apparatus according to claim 1 (see 102 rejection above). However, Keenan does not expressly teach a ratio between the pick density of the braid within the first portion of the delivery tube to pick density of the braid within the third portion of the delivery tube is between 3:2 and 5:2.
Colgan, concerned with the common problem of delivering medical devices through tortuous vasculature, discloses a catheter stent with an outer sheath covering the stent. Colgan discloses a braid (para (99); LCP fiber braid or metal braided coil), wherein a ratio between the pick density of the braid within the first portion of the delivery tube (para. (90; third layer; see para. (93) for more details about the outer sheath 382) to pick density of the braid within the third portion of the delivery tube is between 3:2 and 5:2. (para. (99): "The third layer which consists of LCP fiber braid or metal braided coil could have variable pick density from proximal end to distal end. At the proximal end, the pick density is 20 pick/in for additional stiffness and tensile strength, and at the distal end, the pick density is 120 pick/in for additional flexibility and radial strength to restrain the stent in the delivery system."; Further, para. (95) mentions where the pick density could vary in between the proximal and distal ends: “The pick density could be 20 pick/in or 120 pick/in, or vary in between.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device, specifically the braids, of Keenan, to include the pick density ratios between 5:2 and 3:2 of two portions of the braid. Both Keenan and Colgan disclose where the pick densities and rigidity is variable along the delivery tube, and Colgan discloses a ratio that is nearly the same as the claimed range. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Keenan with Colgan, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05). One of ordinary skill would be able to try different pick densities at different portions of the braid until arriving at the claimed range of pick densities.
Regarding claim 3, Keenan teaches the apparatus according to claim 1 (see 102 rejection above). However, Keenan does not expressly teach where a pick density of the braid within the first portion of the delivery tube is between 30 and 50 picks per inch and the pick density of the braid within the third portion of the delivery tube is between 15 and 25 picks per inch.
Colgan discloses a pick density of the braid within the first portion of the delivery tube is between 30 and 50 picks per inch and the pick density of the braid within the third portion of the delivery tube is between 15 and 25 picks per inch. (para. (99): "The third layer which consists of LCP fiber braid or metal braided coil could have variable pick density from proximal end to distal end. At the proximal end, the pick density is 20 pick/in for additional stiffness and tensile strength, and at the distal end, the pick density is 120 pick/in for additional flexibility and radial strength to restrain the stent in the delivery system."; Further, para. (95) mentions where the pick density could vary in between the proximal and distal ends: “The pick density could be 20 pick/in or 120 pick/in, or vary in between.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device, specifically the braids, of Keenan, to include the claimed pick densities of two portions of the braid. Both Keenan and Colgan disclose where the pick densities and rigidity is variable along the delivery tube, and Colgan discloses pick densities substantially overlapping that of the claimed pick densities. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Keenan with Colgan, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05). One of ordinary skill would be able to try different pick densities at different portions of the braid until arriving at the claimed range of pick densities.
Regarding claim 4, Keenan teaches the apparatus according to claim 1 (see 102 rejection above). However, Keenan does not expressly teach wherein the flexural rigidity monotonically increases between the first portion of the delivery tube and the third portion of the delivery tube.
Colgan discloses wherein a flexural rigidity monotonically increases between the first portion of the delivery tube and the third portion of the delivery tube. (para. (99): "The third layer which consists of LCP fiber braid or metal braided coil could have variable pick density from proximal end to distal end. At the proximal end, the pick density is 20 pick/in for additional stiffness and tensile strength, and at the distal end, the pick density is 120 pick/in for additional flexibility and radial strength to restrain the stent in the delivery system. The transition length can be abrupt or gradual (1 cm to 25 cm)."; "[A]brupt" transition implies a monotonical increase).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device, specifically the braids, of Keenan, to include monotonically increasing flexural rigidity between the first and third portions of the tube, as disclosed by Colgan. One of ordinary skill would recognize that including the braid of Colgan in the apparatus of Keenan would improve the flexibility and pushability without kinking to provide effective delivery of the LVAD device (i.e., the impeller) (see Colgan para (15)) Therefore, it would have been obvious for one of ordinary skill to modify the braided tube of Keenan with that of Colgan to improve the delivery of medical devices through vasculature.
Regarding claim 8, Keenan teaches the apparatus according to claim 7 (see above). However, Keenan does not expressly teach wherein the flexural rigidity monotonically increases between the first portion of the delivery tube and the distal end of the delivery tube.
Colgan discloses wherein the flexural rigidity monotonically increases between the first portion of the delivery tube and the distal end of the delivery tube. (para. (99): "The third layer which consists of LCP fiber braid or metal braided coil could have variable pick density from proximal end to distal end. At the proximal end, the pick density is 20 pick/in for additional stiffness and tensile strength, and at the distal end, the pick density is 120 pick/in for additional flexibility and radial strength to restrain the stent in the delivery system. The transition length can be abrupt or gradual (1 cm to 25 cm)."; "Abrupt" transition implies a monotonical increase; Given the broadest reasonable interpretation of first portion and a distal portion, in the case of Colgan, the denser end (120 pick/in) could be considered the distal end, and less dense end (20 pick/in) could be considered to be the first portion. For the same reason as above, it would have been obvious to modify the device of Keenan with the braids of Colgan.
Claims 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 11077294 B2, "Keenan"), in view of Mitze et al. (US 20220161018 A1, “Mitze”).
Regarding claims 12-15, Keenan discloses the apparatus according to claim 11 (see above). However, Keenan does not expressly disclose wherein a tensile rigidity of the delivery tube is more uniform than the flexural rigidity of the delivery tube (claim 12; Keenan, however, does mention the tensile strength in para. (40)); wherein a tensile-rigidity ratio between the tensile rigidity at the second portion of the delivery tube and the tensile rigidity at the first portion of the delivery tube is less than a flexural-rigidity ratio between the flexural rigidity at the second portion of the delivery tube and the flexural rigidity at the first portion of the delivery tube (claim 13); wherein a tensile-rigidity ratio between the tensile rigidity at the third portion of the delivery tube and the tensile rigidity at the second portion of the delivery tube is less than a flexural-rigidity ratio between the flexural rigidity at the third portion of the delivery tube and the flexural rigidity at the second portion of the delivery tube (claim 14); and wherein a tensile-rigidity ratio between the tensile rigidity at the third portion of the delivery tube and the tensile rigidity at the first portion of the delivery tube is less than a flexural-rigidity ratio between the flexural rigidity at the third portion of the delivery tube and the flexural rigidity at the first portion of the delivery tube (claim 15).
Mitze, in the same field of endeavor of circulatory assist devices, discloses a transcatheter system for device delivery to the heart. Mitze discloses a braid section (220b) for an inlet to tube (105b), and where the braids give the tube the ability to adjust the rigidity of the inlet tube (para. [0121]: “The braid section 220b may extend over at least half of the inlet tube 105b in order to adjust the rigidity of the inlet tube 105b…). Mitze further discloses where the inlet tube must be flexible enough to pushed through the aortic arch (one of ordinary skill would know bending around the arch correlates to flexural rigidity), and where the tube must be stiff enough to be pushed through the axial direction without kinking (one of ordinary skill would know axial stress correlates to tensile rigidity; see para. [0121]). Lastly, Mitze discloses where the requirements for flexibility and rigidity can be met by design of the braid structure (para. [0121]: “The inlet tube 105b may thus be flexible enough to be able to be pushed through the aortic arch, and also has a rigidity so that it can be pushed through the blood vessels in the axial direction without kinking. The relevant requirements for flexibility and rigidity of the inlet tube 105 are set by means of the shaping of the braid section 220. The design of the braid structure can determine the ratio of flexibility and rigidity.”).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the apparatus as taught by Keenan with a braided structure with higher flexural rigidity than tensile rigidity in certain areas of the tube since it has been held that where the general conditions of a claim are disclosed in the prior art (in this case, both Mitze and Keenan are in the same field of LVAD delivery tubing, and the tubing must have enough flexural and tensile rigidity to traverse the aortic arch and deliver an impeller to the left ventricle, as disclosed by Mitze), discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05). Mitze discloses where the design of the braid structure determines the rigidity and flexibility of the delivery tube (para. [0121]). One of ordinary skill in the art would recognize that optimizing the ratio of tensile rigidity and flexural rigidity would be a matter of experimenting until finding the optimal rigidity ratios for each portion of the tubing. Further, both Keenan and Mitze disclose using braided tubing for the same purpose (delivery of an impeller to the left ventricle). Thus, both the tubing of Keenan and Mitze have the same functional requirements (flexural and tensile rigidity). Therefore, one of ordinary skill would know, as Mitze discloses, that the braid structure could be varied until the optimal ratio of flexural and tensile rigidity for the different sections of tubing are achieved. Therefore, it would have been a matter of routine optimization of flexural and tensile rigidity to arrive at the claimed tensile-rigidity to flexural-rigidity ratios at the first, second, and third portion of the tubing, as well as where the tensile rigidity is more uniform than the flexural rigidity.
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 11077294 B2, "Keenan"), Mitze et al. (US 20220161018 A1, “Mitze”), and Bredenbreuker et al. (US 20140255176 A1, "Bredenbreuker").
Regarding claims 15 and 16, Keenan, in combination with Mitze, discloses the apparatus according to claim 12 (see above). However, neither reference discloses wherein the delivery tube further comprises at least one fiber that extends along the length of the delivery tube and increases the tensile rigidity of the delivery tube, relative to if the delivery tube would not comprise the fiber (claim 15), or wherein the fiber comprises an aramid fiber (claim 16).
Bredenbreuker, in the same field of endeavor of circulatory assist pump devices, discloses a catheter-based device for pump delivery through vasculature to the heart. Bredenbreuker discloses at least one fiber that extends along the length of the delivery tube (housing) and increases the tensile rigidity of the delivery tube, relative to if the delivery tube would not comprise the fiber. (para. (33): "For the stabilization of the stretch-resistant element, in particular of also of the entire housing skin, it may also be advantageously provided that the stretch-resistant element has stretch-resistant fibers extending in circumferential direction, in particular glass fibers or carbon fibers. Other fibers or reinforcement elements for improving the stretch resistance are also conceivable."; para. [0096]: " The stretch-resistant element 37 may be embodied, for example, as a high-strength plastic film, in particularly also with reinforcement fibers revolving in circumferential direction, e.g. made from or with glass fiber or carbon fiber materials, or also from or with aramide fibers or nylon fibers."); and wherein the fiber comprises an aramid fiber (para. [0033]: "For the stabilization of the stretch-resistant element, in particular of also of the entire housing skin, it may also be advantageously provided that the stretch-resistant element has stretch-resistant fibers extending in circumferential direction, in particular glass fibers or carbon fibers. Other fibers or reinforcement elements for improving the stretch resistance are also conceivable."; para. [0096]: " The stretch-resistant element 37 may be embodied, for example, as a high-strength plastic film, in particularly also with reinforcement fibers revolving in circumferential direction, e.g. made from or with glass fiber or carbon fiber materials, or also from or with aramide fibers or nylon fibers.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Keenan to include the fiber element of Bredenbreuker. One of ordinary skill would recognize that the fiber of Bredenbreuker would provide increased stretch-resistance and tensile strength, as disclosed by Bredenbreuker. In doing so, it would be advantageous in that the delivery tube would have more strength and durability during delivery through vasculature. Therefore, it would have been an obvious improvement to include the fiber of Brendenbreuker in the device of Keenan.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Keenan et al. (US 11077294 B2, "Keenan") in view of Tuval et al. (US 20220079457 A1, “Tuval”).
Regarding claim 18, Keenan discloses a method, comprising: inserting an impeller (Fig. 4; 112) and a delivery tube (Catheter body 104) into a body of a subject (Fig. 3; para. (25): "A distal portion of the pump 10 is placed in the left ventricle LV of the heart to pump blood from the LV into the aorta."), the delivery tube including a braid (para. (42): "In addition to the foregoing structures for varying the stiffness along the length of the catheter body 104, a separate stiffening component, such as a braid 188, can be disposed in the catheter body 104, 104A."; para. (43): " As discussed above, the catheter assembly 100 preferably also includes an outer sheath or sheath assembly 88 provided over the elongate body 104, 104A to aid in delivering, deploying and/or removing the impeller 112." ; Fig. 6A-D) having a pick density that varies along a length of the delivery tube (para. (51): "A braided structure 157 can be provided along at least a portion of the length of the sheath assembly 88′ to provide reinforced mechanical strength, e.g., improved longitudinal or axial strength and improved radial strength. In one embodiment a stiffness contribution by the braided structure 157 varies along the length of the sheath assembly 88′, for example providing a denser braid in the proximal portion 153A than in portions of the sheath assembly 88′ distal the proximal portion 153A."; para. (53): "The second portion 153B can be configured with less stiffness than the proximal portion 153A. The second portion 153B can have a portion of the braided structure 157 that is less stiff, e.g., lower braid density, than the portion of the braided structure 157 in the proximal portion 153A.") such that a flexural rigidity of the delivery tube at a first portion of the delivery tube is less than the flexural rigidity at a second portion of the delivery tube, and the flexural rigidity at the second portion is less than the flexural rigidity at a third portion of the delivery tube (para. (53) mentions the portions of the sheath assembly 88', and where the position markers decrease in stiffness: "The second portion 153B can be configured with less stiffness than the proximal portion 153A. The second portion 153B can have a portion of the braided structure 157 that is less stiff, e.g., lower braid density, than the portion of the braided structure 157 in the proximal portion 153A… A third portion 153C disposed distal the second portion 153B can have a lesser stiffness than in the second portion 153B." ; Para. (53) also discloses that the braid density is varied to achieve the change in stiffness.); positioning the impeller and delivery tube such that the impeller is disposed within a left ventricle of a heart of the subject (Fig. 3; impeller assembly 92 shown disposed in left ventricle) and the delivery tube passes through an aorta of the subject from outside the subject into the left ventricle (para. (9): “The method can include advancing a distal portion of a catheter assembly including an impeller assembly and a catheter body to a treatment location of a patient. The method can include contacting an outer surface of the catheter body with a contact zone of an inner wall of an aorta of the patient to secure at least the distal portion of the catheter assembly against the aorta of the patient, the inner wall being located adjacent to the junction of the ascending aorta and the aortic arch.”); the second portion of the delivery tube traversing at least a portion of an aortic arch of the subject, and the third portion of the delivery tube traversing a descending aorta of the subject (para. (9); Fig. 6D-4; what can be considered as a second portion is shown traversing the aortic arch, and what can be considered a third portion can be shown traversing the descending aorta.); and using a drive cable, which passes through the delivery tube, rotating the impeller so as to pump blood of the subject from the left ventricle into the aorta (para. (32): "The drive shaft 144 couples with the motor at the proximal end and with the impeller 112 at the distal end thereof. The drive shaft 144 can be formed with any suitable structure, but should be sufficient flexible to traverse at least from a peripheral (e.g., femoral) artery to a heart chamber, such as the left ventricle, as well as sufficiently durable to rotate at a high speed for several hours, for several days, and in some cases, months."; the drive shaft is coupled with the motor to rotate the impeller and assist with pumping blood to the aorta from the left ventricle.). However, Keenan does not expressly disclose where the method includes the first portion of the delivery tube traversing the aortic valve of the subject (Keenan only shows the impeller assembly, not the catheter body, traversing the aortic valve).
Tuval, in the same field of endeavor of methods and devices for circulatory assist devices, discloses a method for delivering an impeller pump. Tuval discloses where a first portion of the delivery tube (pump-outlet tube 24) traverses the aortic valve (26) of the subject (Fig. 1B; para. [0159]: “The ventricular assist device includes a pump-outlet tube 24, which traverses an aortic valve 26 of the subject.”).
It would have been obvious for one of ordinary skill in the art to modify the method of Keenan to further include where a delivery tube extends past the aortic valve. One of ordinary skill in the art would recognize that the aortic valve is an anatomical feature preceding the left ventricle. Both Keenan and Tuval are concerned with pumping blood from the left ventricle through the aorta. Thus, it would have been obvious to include a tube that extends through the aortic valve to provide access to the left ventricle, and to improve circulation from the left ventricle. Thus, it would have been obvious for one of ordinary skill in the art to modify the method of Keenan with that of Tuval since Tuval shows a delivery tube traversing the aortic valve.
Conclusion
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/O.L.M./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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