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
2. Applicant’s election without traverse of Group I and Species I (claims 1-13) in the reply filed on 7/20/2026 is acknowledged. Thus, claims 14-22 are withdrawn from consideration.
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 1-3, and 6-7 are rejected under 35 U.S.C 103 as being unpatentable over Tuval et al. (US Pub.: 2019/0209753 A1) and further in view of Gerberding et al. (US Pub.: 2004/0193206 A1).
Regarding claim 1, Tuval teaches an apparatus, comprising:
a blood pump (e.g. Fig. 2A – blood pump portion 27; paragraphs 0448, 0450), comprising:
a pump-outlet tube (e.g. Fig. 2A – tube 24) shaped to define one or more blood-outlet openings (e.g. Fig. 2A – blood outlet openings 109) and configured for insertion into a heart of a subject (e.g. paragraphs 0448, 0450);
an impeller (e.g. Fig. 2A – impeller 50) disposed within a distal portion of the pump-outlet tube (e.g. Fig. 2A – distal portion 102 of tube 24) and configured to pump blood of the subject proximally through the pump-outlet tube (e.g. paragraphs 0450, 0455), such that the blood exits the pump-outlet tube through the blood-outlet openings (e.g. paragraphs 0450, 0455);
a delivery tube (e.g. Fig. 16C – outer tube 142) configured to extend, from outside a body of the subject, through the pump-outlet tube to the distal portion (e.g. paragraphs 0199, 0539);
and a drive cable (e.g. Fig. 16C – drive cable 130) passing through the delivery tube (142) and configured to rotate the impeller (50) (e.g. paragraphs 0451, 0539), a proximal portion of the pump-outlet tube (e.g. Fig. 2A – proximal portion 106 of tube 24) (e.g. paragraph 0455).
However, Tuval does not explicitly teach a proximal portion of the pump-outlet tube comprising multiple strips adhered to the delivery tube.
Gerberding, in a same field of endeavor of catheter-based intravascular devices, discloses an intravascular device comprising multiple strips adhered to the delivery tube (e.g. Figs. 14A-14C – plurality of strips 102 and 104 adhered to outer tube 64; paragraphs 0066-0068).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal portion of the pump-outlet tube of Tuval to incorporate multiple strips adhered to the delivery tube on the proximal side, distal side, or the entire length of the tube (e.g. paragraphs 0071, 0073), as taught and suggested by Gerberding, in order to provide the predictable results of maintain radial expandability and flexibility while defining spaces between adjacent structural members (Gerberding, paragraph 0067).
Regarding claim 2, Tuval in view of Gerberding teaches the apparatus according to claim 1 as discussed above, and Tuval further teaches wherein the proximal portion of the pump-outlet tube is conical (e.g. Fig. 2A – conical proximal portion 42; paragraph 0462). Additionally, Gerberding further teaches by virtue of the strips being adhered to the delivery tube (e.g. paragraphs 0066-068).
Regarding claim 3, Tuval in view of Gerberding teaches the apparatus according to claim 1 as discussed above, and further teaches wherein the strips are adhered to the delivery tube (Gerberding; strips 102 and 104; paragraphs 0066-0068) so as to define at least some of the blood-outlet openings (Tuval; blood outlet opening 109; paragraphs 0450, 0455) between the strips (Gerberding; paragraphs 0071-0073).
Regarding claim 6, Tuval in view of Gerberding teaches the apparatus according to claim 1 as discussed above, and Tuval further teaches wherein the pump-outlet tube (24) comprises a cylindrical portion (e.g. Fig. 2A – cylindrical central portion 44) that is distal to the proximal portion (e.g. paragraph 0462), and wherein the cylindrical portion (44) of the pump-outlet tube (24) is shaped to define at least some of the blood-outlet openings (e.g. paragraph 0455), such that the at least some of the blood-outlet openings are laterally facing (e.g. Figs. 2A-2B; paragraph 0461).
Regarding claim 7, Tuval in view of Gerberding teaches the apparatus according to claim 1 as discussed above, and further teaches wherein the proximal portion of the pump-outlet tube (Tuval; Figs. 2A-2B – proximal portion 106 of tube 24; paragraph 0455) is not molded (Gerberding; paragraphs 0066-0068).
Claims 4-5 are rejected under 35 U.S.C 103 as being unpatentable over Tuval and further in view of Gerberding and further in view of Salahieh et al. (US Pub.: 2019/0344001 A1).
Regarding claim 4, Tuval in view of Gerberding teaches the apparatus
according to claim 3 as discussed above. However, Tuval in view of Gerberding does not explicitly teach wherein at least some of the blood-outlet openings are laser cut from the pump-outlet tube.
Salahieh, in a same field of endeavor of intravascular devices, discloses wherein at least some of the blood-outlet openings are laser cut from the pump-outlet tube (e.g. paragraphs 0134, 0167, 0169).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Tuval and Gerberding to incorporate wherein at least some of the blood-outlet openings are laser cut from the pump-outlet tube, as taught and suggested by Salahieh, because laser cutting provides a known manufacturing technique for producing defined apertures/openings in tubular structures in a more precise and rapid manner.
Regarding claim 5, Tuval in view of Gerberding teaches the apparatus
according to claim 1 as discussed above. However, Tuval in view of Gerberding does not explicitly teach wherein at least some of the blood-outlet openings are laser cut from the pump-outlet tube.
Salahieh, in a same field of endeavor of intravascular devices, discloses wherein at least some of the blood-outlet openings are laser cut from the pump-outlet tube (e.g. paragraphs 0134, 0167, 0169).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Tuval and Gerberding to incorporate wherein at least some of the blood-outlet openings are laser cut from the pump-outlet tube, as taught and suggested by Salahieh, because laser cutting provides a known manufacturing technique for producing defined apertures/openings in tubular structures in a more precise and rapid manner.
Claims 8-11 and 13 are rejected under 35 U.S.C 103 as being unpatentable over Tuval and further in view of Gerberding and further in view of Varghai et al. (International Publication No.: WO 2021/243263 A1).
Regarding claim 8, Tuval in view of Gerberding teaches the apparatus according to claim 1 as discussed above. However, Tuval in view of Gerberding does not explicitly teach further comprising an expandable element surrounding the delivery tube at least partially proximally to the blood-outlet openings, a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm.
Varghai, in a same field of endeavor of intravascular devices, discloses further comprising an expandable element (e.g. Fig. 31 – expandable flow diverter 3130) surrounding the delivery tube (e.g. paragraph 0221) at least partially proximally to the blood-outlet openings (e.g. Fig. 31; paragraphs 0220-0224), a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm (e.g. paragraphs 0219-0220, 0223 – 0.1-1 inch = 2.54-25.4 mm which is less than 30mm).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Tuval and Gerberding to include an expandable element surrounding the delivery tube at least partially proximally to the blood-outlet openings, a length of the delivery tube between the expandable element and the blood-outlet openings being less than 30 mm, as taught and suggested by Varghai, for the purpose of reducing undesirable recirculation as well as to reduce hemolysis (Varghai, paragraph 183).
Regarding claim 9, Tuval in view of Gerberding in view of Varghai teaches the apparatus according to claim 8 as discussed above, and Varghai further teaches wherein the expandable element (3130) is entirely proximal to the pump-outlet tube (e.g. paragraphs 0182, 0221, 0223).
Regarding claim 10, Tuval in view of Gerberding in view of Varghai teaches the apparatus according to claim 8 as discussed above, and Varghai further teaches wherein the expandable element (3130) includes an inflatable element (e.g. Fig. 31 – expandable flow diverter 3130; paragraph 0221).
Regarding claim 11, Tuval in view of Gerberding in view of Varghai teaches the apparatus according to claim 10 as discussed above, and Varghai further teaches wherein the inflatable element (3130), when inflated, is disposed at least partly within the pump-outlet tube (e.g. paragraphs 0192, 0198, 0221).
Regarding claim 13, Tuval in view of Gerberding in view of Varghai teaches the apparatus according to claim 8 as discussed above, and Varghai further teaches wherein the inflatable element (3130) is shaped to direct the blood (e.g. paragraphs 0184-0186, 0221) through at least some of the blood-outlet openings (e.g. paragraphs 0191, 0205, 0219-0220).
Claim 12 is rejected under 35 U.S.C 103 as being unpatentable over Tuval and further in view of Gerberding and further in view of Varghai and further in view of Siess et al. (US Pub.: 2019/0046702 A1).
Regarding claim 12, Tuval in view of Gerberding in view of Varghai teaches the apparatus according to claim 10 as discussed above, and Varghai further teaches the inflatable element (3130) (e.g. paragraph 0221).
However, Tuval in view of Gerberding in view of Varghai does not explicitly teach wherein the inflatable element is disposed entirely within the pump-outlet tube.
Siess, in a same field of endeavor of intravascular devices, discloses wherein the inflatable element is disposed entirely within the pump-outlet tube (e.g. paragraphs 0012, 0019, and 0047).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Tuval, Gerberding, and Varghai to incorporate wherein the inflatable element is disposed entirely within the pump-outlet tube, as taught and suggested by Siess, in order to provide internal radial reinforcement to keep the tubular structure open and circular during blood-pump operation (Siess, paragraph 0047).
Conclusion
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/D.T./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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