DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 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 20 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.
Claim 20 contains limitations that attempt to define the invention with negative limitations. While negative limitations in and of themselves are not grounds for rejection, in this case, they introduce indefiniteness into the claim. Claim 20 states that the system comprises an “atraumatic configuration with tissue contact surfaces that are devoid of tissue hooks”. MPEP 2173.05(i) teaches “the court observed that the limitation "R is an alkenyl radical other than 2-butenyl and 2,4-pentadienyl" was a negative limitation that rendered the claim indefinite because it was an attempt to claim the invention by excluding what the inventors did not invent rather than distinctly and particularly pointing out what they did invent. In re Schechter, 205 F.2d 185, 98 USPQ 144 (CCPA 1953)”.
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.
Claim(s) 1 and 2 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robinson et al (WO2021/119478A1); hereinafter Robinson.
Regarding claim 1, Robinson teaches a catheter blood pump (fig. 2, [0046]-[0049]) comprising:
An impeller (distal impeller, fig. 2, [0046]-[0049], blood pump is shown to have a distal impeller positioned within the expandable device);
An outlet cage at least partially surrounding the impeller ([0037] expandable shroud around impellers, fig. 2, [0046]-[0049]);
A drive cable operatively coupled to a motor at a proximal end thereof, and operatively coupled to the impeller at a distal end thereof ([0053] drive mechanism 472 that is coupled to an external motor, fig. 2 shows a similar drive mechanism 472coupled to an external motor);
A catheter, wherein the drive cable is disposed within the catheter (220. fig. 2, the drive mechanism is reasonably considered to extend through sheath 220 to communicate with the external motor); and an antimigration brace (anchor 260' is shown to be coupled to a component of the sheath 220 via the inflation lumen 260) is configured to have a first configuration during a tortuous insertion of the catheter into a patient and a deployable second configuration that is larger than the first configuration when in position in target anatomy of the patient whereby the anti-migration brace expands laterally outwardly in size from the first configuration to the second configuration (based on fig. 2, anchor 260] can reasonably be considered to be deflated during navigation).
Regarding claim 2, Robinson teaches the catheter blood pump of Claim 1, wherein, in the second configuration, the anti- migration brace increases in size in a longitudinal direction from a first position to a second more distal position closer to the impeller (fig. 2, [0046]-[0049], the inflation of anchor 260' is reasonably considered to cause the anchor 260] to expand in a longitudinal direction toward the distal impeller).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3, 5-10, 14-18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Tuval et al (US20190269840A1); hereinafter Tuval.
Regarding claim 3, Robinson teaches the blood pump of claim 1. Robinson fails to teach the location of the anti-migration brace. Tuval teaches the anti-migration brace is disposed on an exterior of the catheter, proximal to the outlet cage (fig. 9A-9B; [0178] the proximal end of support cage 180 is shown to connect to the distal end of the catheter and the proximal end of the support cage 180 is shown to be proximal to impeller cage 30 of impeller 28U). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Tuval because there is some teaching, suggestion, or motivation to do so. Tuval teaches that this location “supports the walls of a portion of the vena cava between the upstream and downstream impellers” ([0178]). Regarding claim 5, Robinson teaches the catheter blood pump of claim 1. Robinson fails to teach the multi-lumen catheter body. Tuval teaches the catheter has a multi-lumen catheter body and comprises at least one longitudinally extending brace lumen (lumen receiving 180 when positioned 180 is positioned within 23; fig. 9A-9B, [0178]-[0182]) , and wherein a distal end portion of the anti-migration brace is configured to be extendable out of the at least one longitudinally extending brace lumen and retractable back into the at least one longitudinally extending brace lumen (fig. 9A-9B, [0178]-[0182] the support cage 180 is reasonably considered to be retracted into 23 upon completion of the use of the device). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Tuval because it constitutes applying a known technique to a known device ready for improvement to yield predictable results. In the art of catheters, using multiple lumens and having the lumens be extendable and retractable is incredibly common, therefore incorporating this idea into the device of Robinson would have been obvious.
Regarding claim 6, Robinson teaches the blood pump of claim 1. Robinson fails to teach the location of the anti-migration brace. Tuval teaches the anti-migration brace is attached to an outer surface of the catheter at a location that is a distance proximal to the impeller (fig.9A-9B; [0178]-[0182] the proximal support cage 180 is shown to be attached to an outer surface of the catheter proximal to the impeller 28U) and that is sized and configured to reside about an aortic wall of an ascending aorta of the patient in the second configuration (fig. 9A-9B; [0181] support cage is taught to comprise a maximum diameter of approximately 30 mm and is considered capable of residing in an aortic wall of an ascending aorta of the patient when expanded). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Tuval because it constitutes use of a known technique to improve similar devices in the same way. Both Robinson and Tuval teach blood pumps, therefore adjusting the location of the anti-migration brace that is present in both inventions to accommodate the anatomy of the aorta would be obvious.
Regarding claim 7, the combination of Robinson and Tuval teaches the catheter blood pump of claim 6, Tuval further teaches the anti-migration brace has a maximal projection at a location that is in a range of 5 mm - 4 cm proximal to a proximal end of the impeller (figs. 9A-9B, [0181], support cage is taught to comprise a maximum diameter of approximately 30mm, wherein the support cage is shown to have a portion proximal to the impeller 28U that is at the maximum diameter).
Regarding claim 8, Robinson teaches the pump of claim 1. Robinson fails to teach where the anti-migration brace is attached to the impeller housing. Tuval teaches the anti-migration brace is attached to an impeller housing distal to the outlet cage (right half of 170, fig. 7D, [0167]-[0168], the left half of 170 is connect to the right half of 170 and the right half of 170 is shown to house the right impeller 28). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Tuval because it is a matter of obvious design choice where the anti-migration brace should be located relative to the outlet cage.
Regarding claim 9, Robinson teaches the pump of claim 1. Robinson fails to teach where the anti-migration brace is attached to the impeller housing. Tuval teaches the anti-migration brace is attached to an impeller housing proximal to the outlet cage (left half of 170, fig. 7d, [0167]-[0168], the right half of 170 is connect to the left half of 170 and the left half of 170 is shown to house the left impeller 28). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Tuval because it is a matter of obvious design choice where the anti-migration brace should be located relative to the outlet cage.
Regarding claim 10, Robinson teaches the pump of claim 1. Robinson fails to teach the structure of the anti-migration brace. Tuval teaches the anti-migration brace comprises an expandable mesh body (body of 180, fig. 9A-9B, [0178]-[0182]) with proximal and distal end portions configured to attach to the component of the catheter blood pump (fig. 9A-9B, [0178]-[0182], the support cage 180 is attached to a proximal hub and a distal hub collectively considered to be the component) and a medial segment therebetween configured to expand into a three-dimensional shape in the second configuration (portion of 180 extending between 28D and 28U, fig. 9A-9B [0178]-[0182]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Tuval because it constitutes use of known technique to a known device ready for improvement to yield predictable results. Robinson and Tuval both teach an anti-migration brace and there are a limited number of ways to allow the brace to be small enough to be inserted intravascularly but also expand to a size that actually fulfills it’s intended purpose.
Regarding claim 14, Robinson teaches the catheter blood pump of claim 1. Robinson fails to teach the plurality of fingers in the anti-migration brace. Tuval teaches a plurality of fingers that project radially outward from the catheter when deployed (proximal struts extending from proximal hub, figs. 9A-9B, [0178]-[0182], the support cage 180 is shown to have proximal struts extending radially outward from the catheter taught by Magenta, wherein each strut is considered to be a finger). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Tuval because there is some teaching, suggestion, or motivation to do so. Tuval teaches that the structure with the fingers “reduces the likelihood of the material and the impeller causing damage to one another during the crimping of the support cage and the impeller” ([0240]).
Regarding claim 15, the combination of Robinson and Tuval teaches the catheter blood pump of claim 14. Tuval further teaches wherein the fingers are circumferentially spaced apart (fig. 9A-9B, [0178]-[0182]) and attached to a tube segment (fig. 9A-9B, [0178]-[0182] the hub where proximal struts of 180 attach is shown to be tubular), and wherein the tube segment is attached to the catheter (fig. 9A-9B, [0178]-[0182], the hub where proximal struts of 180 attach is shown to be attached to the catheter taught by Magenta).
Regarding claim 16, the combination of Robinson and Tuval teaches the catheter blood pump of claim 15. Tuval further teaches in the first configuration, the fingers define a cylinder aligned with the tube segment (fig. 9A-9B, [0178]-[0182], when the support cage 180 is in a constrained state within guide catheter 23, the proximal struts of the support cage 180 are reasonably considered to collapse radially and align with the hub axially and form a cylindrical shape).
Regarding claim 17, the combination of Robinson and Tuval teaches the catheter blood pump of claim 16. Tuval further teaches the anti-migration brace is provided by a tubular body with first and second circumferentially spaced apart and longitudinally extending slits separate a respective finger (fig. 9A-9B, [0178]-[0182], the proximal struts of support cage 180 in the collapsed configuration are reasonably considered to form a tubular body, wherein the openings between each strut are considered to collapse as well and form slits between the struts).
Regarding claim 18, the combination of Robinson and Tuval teaches the catheter blood pump of claim 15. Tuval further teaches the plurality of fingers are provided in a number of 3 to 8 fingers (fig. 9A-9B, [0178]-[0182], the support cage 180 is shown to have 8 proximal struts attached to the proximal hub).
Regarding claim 20, Robinson teaches the catheter blood pump of Claim 1. Robinson fails to teach that the brace has an atraumatic configuration devoid of hooks. Robinson teaches the anti-migration brace has an atraumatic configuration with tissue contact surfaces that are devoid of tissue hooks (fig. 9A-9B, [0178]-[0182], the support cage 180 is shown to have an outer surface that contacts the vessel of the patient and is devoid of tissue hooks). This would have been obvious because it constitutes using a known technique to improve similar devices. Using atraumatic methods to secure pumps in blood vessels is a known technique and Robinson and Tuval both already teach blood pumps. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson to specify that the anti-migration brace is atraumatic and devoid of hooks.
Claim(s) 4,11-13, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Georges et al (US20210162196A1); hereinafter Georges.
Regarding claim 4, Robinson teaches the catheter blood pump of claim 1. Robinson fails to teach the sheath enclosing the anti-migration brace. Georges teaches a sheath enclosing the anti- migration brace when the anti-migration brace is in the first configuration (20, fig. 87 [0355]), wherein the sheath is configured to force the anti-migration brace against the component of the catheter blood pump and provide a profile of 6F-18F in the first configuration (fig. 87, [0355], the compression of anchor assembly 56 by sheath 20 causes anchor assembly 56 to compress against 42 - further, 42 is taught to have a 4,, diameter, or 12F, [0344], wherein the anchor assembly 56 is considered to have a similar diameter in the constrained configuration). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Georges because there is some teaching, suggestion, or motivation to do so. Robinson teaches that the anchor 260’ may optionally be adapted to be inflatable ([0046]). Therefore, it would have obvious to modify Robinson accordingly.
Regarding claim 11, Robinson teaches the catheter blood pump of claim 1. Robinson fails to teach the expandable lasso structure. Georges teaches the anti-migration brace comprises an expandable lasso (fig. 88, [0357], anchor assembly 56 is shown to comprise a right portion that is an expandable lasso in shape). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Georges because it constitutes simple substitution of one known element for another to yield predictable results. Both Robinson and Georges teach blood pumps that are anchored in a blood vessel and it achieves the same purpose of holding the pump in place. Replacing the anchor of Robinson for the anchor of Georges would be obvious to someone having ordinary skill in the art.
Regarding claim 12, the combination of Robinson and Georges teaches the catheter blood pump of claim 11. Georges further teaches the expandable lasso has a single loop (fig. 88, [0357], the right portion is shown to comprise a single loop).
Regarding claim 13, the combination of Robinson and Georges teaches the catheter blood pump of claim 11. Georges further teaches the expandable lasso has an open loop configuration (fig. 88 [0357] the right portion is shown to be a loop with an opening and is considered to be an open loop configuration).
Regarding claim 21, the combination of Robinson and Georges teaches the catheter blood pump of claim 4. Georges further teaches on introduction of the catheter blood pump into the patient, the sheath contains the at least part of the catheter and the anti- migration brace (fig. 87, [0355]), and wherein the anti-migration brace is physically adapted to automatically expand when the sheath is partially slidably withdrawn relative to the catheter or the catheter is partially slidably extended relative to the sheath (fig. 87-88, [0357], the anchor assembly 56 is taught to be biased toward the anchored assembly, wherein the removal of sheath 20 causes anchor assembly 56).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Calomeni et al (US20210008261A1); hereinafter Calomeni. Robinson teaches the catheter blood pump of claim 1. Robinson fails to teach the structure of the anti-migration brace. Calomeni teaches the anti-migration brace comprises a spiral member with a series of circumferential segments that increase in radius from a proximal end to a more distal end (269, fig. 5, [0129], the helical member is shown to increase in radius in the distal direction, since the expandable member 270 increases in radius) and that have radial extents that are greater than an outer diameter of a catheter body (fig. 5, [0129] see analogous fig. 10C showing a similar expandable member having an outer diameter greater than the sheath body of 322, wherein the helical member 269 is considered to be greater than the outer diameter of a sheath body as well). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Robinson with Calomeni because there is some teaching, suggestion, or motivation to do so. Calomeni teaches that the helical structure allows the anti-migration brace to be adapted to induce rotation wrap upon collapse ([0129]). This teaching would make it obvious to make the anti-migration brace of Robinson specifically a spiral member with circumferential segments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796