DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 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.
Claims 4, 24 are 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 4, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 24, the limitation of the tip portion having a pigtail shape contradicts the specification and it is unclear if the pigtail shape would be workable in the claimed invention (see specification pg. 92, lines 1-14). The addition of the sentence stating “notwithstanding the above, however, it is noted that in some embodiments, distal-tip element 107 has a pigtail shape” does not provide any additional information as to how the previous limitations presented would be overcome.
Claim Rejections - 35 USC § 102
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 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, 3-4, 7-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mitze et al. (US Pre-Grant Publication 2022/0161018), hereinafter ‘Mitze’.
Regarding claim 1, Mitze teaches an apparatus (Fig. 1) comprising:
a device (Fig. 1) configured for insertion into a left ventricle of a heart of a subject ([0005], left ventricle);
a delivery tube ([0062], guidewire extends throughout catheter shaft, inlet tube 70, Figs. 8A-8B) coupled to the device and configured to traverse an aortic arch of the subject while the device is within the left ventricle;
and an elongation-resistant fiber running axially along the delivery tube (guidewire 1111, Fig. 1) so as to bias an orientation of the delivery tube while the delivery tube traverses the aortic arch such that the elongation-resistant fiber is disposed inside a curve of the aortic arch, thereby biasing an orientation of the device ([0121], guidewire coils as in Fig. 1, flexible enough for insertion through aortic arch).
Regarding claim 3, Mitze teaches the device according to claim 1, further comprising:
wherein at least a portion of the elongation-resistant fiber is not parallel to a longitudinal axis of the delivery tube ([0054], distal zone of body 101 is preshaped, Figs. 5-6).
Regarding claim 4, Mitze teaches the device according to claim 3, further comprising:
wherein the portion of the elongation-resistant fiber is configured to twist a portion of the delivery tube that passes through an ascending aorta in a vicinity of the aortic valve, such as to conform with an anatomical twist of the ascending aorta in the vicinity of the aortic valve ([0121], insertion through aortic arch).
Regarding claim 7, Mitze teaches the device according to claim 1, further comprising:
wherein the elongation-resistant fiber is disposed within a wall of the delivery tube ([0061], second guidewire port 78, Fig. 8A).
Regarding claim 8, Mitze teaches the device according to claim 7, further comprising:
wherein the delivery tube comprises a braid, and wherein the elongation-resistant fiber is threaded through the braid ([0119], braided).
Regarding claim 9, Mitze teaches the device according to claim 1, further comprising:
wherein the device comprises a blood pump configured to pump blood of the subject from the left ventricle ([0104], pump 100 may be blood pump),
and wherein the apparatus comprises a left-ventricular assist device ([0104], ventricular assist device) comprising the device, the delivery tube, and the elongation-resistant fiber (Fig. 3).
Regarding claim 10, Mitze teaches the device according to claim 9, further comprising:
wherein the left-ventricular assist device further comprises a drive cable, which is distally coupled to the blood pump and passes through the delivery tube ([0069], drive shaft 140, Figs. 9A, 9B).
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.
Claim(s) 1-16, 18-23, 25 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US Pre-Grant Publication 2020/0237985), hereinafter ‘Tuval’, in view of Chou (US Pre-Grant Publication 2020/0289136), hereinafter ‘Chou’.
Regarding claim 1, Tuval teaches an apparatus (Fig. 1A), comprising:
a device (ventricular assist device (20), Fig. 1B) configured for insertion into a left ventricle of a heart of a subject ([0222], insertion of device in left ventricle);
a delivery tube (delivery catheter (143)) coupled to the device and configured to traverse an aortic arch of the subject while the device is within the left ventricle ([0376], delivery catheter is guided along aortic arch); and
a structure ([0312], first and second outer tubes (140, 142, respectively) running axially along the delivery tube (Fig. 10A) so as to bias an orientation of the delivery tube while the delivery tube traverses the aortic arch such that the structure is disposed inside a curve of the aortic arch, thereby biasing an orientation of the device ([0394], 140/142 are shaped to define curved shapes).
Tuval does not teach that the structure is an elongation-resistant fiber.
Chou teaches a catheter system for insertion into a cerebral vessel of a patient [0022], further comprising:
and an elongation-resistant fiber (reinforcement fiber (801)) running axially along the delivery tube (Figs. 8B, 8C) so as to bias an orientation of the delivery tube [0150].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include an elongation-resistant fiber that biases the orientation of the delivery tube. Doing so would prevent elongation, as recognized by Chou [0145].
Regarding claim 2, Tuval and Chou teach the device according to claim 1. Chou teaches the device further comprising:
wherein the elongation-resistant fiber is an aramid fiber ([0284], reinforcement fiber material can be various high tenacity polymers like Kelvar).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include an elongation-resistant aramid fiber. Doing so would provide mechanical integrity, as recognized by Chou [0284].
Regarding claim 3, Tuval and Chou teach the device according to claim 1. Tuval teaches the device further comprising:
wherein at least a portion of the elongation-resistant fiber is not parallel to a longitudinal axis of the delivery tube ([0382], curved portion of distal tip element 107 curves away from longitudinal axis 348, Fig. 22A).
Regarding claim 4, Tuval and Chou teach the device according to claim 3. Tuval teaches the device further comprising:
wherein the portion of the elongation-resistant fiber is configured to twist a portion of the delivery tube that passes through an ascending aorta in a vicinity of the aortic valve, such as to conform with an anatomical twist of the ascending aorta in the vicinity of the aortic valve ([0376], distal tip portion guides delivery catheter along curved anatomy, e.g. aortic arch).
Regarding claim 5, Tuval and Chou teach the device according to claim 3. Chou teaches the device further comprising:
wherein a length of the portion is between 5 and 20 cm ([0181], elongate body (360) is at least about 5cm, up to 50cm).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include a length of the portion between 5-20cm. Doing so would allow for the device to reach cerebrovascular targets, as recognized by Chou [0182].
Regarding claim 6, Tuval and Chou teach the device according to claim 3.
Tuval discloses the circumferential span can vary in angle as desired but does not explicitly disclose a range of 30-60 degrees. Fig. 26 A-F appear to disclose such a span, but the Examiner notes the drawings are not necessarily to scale. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to limit the angle to between 30 and 60 degrees, 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.
Regarding claim 7, Tuval and Chou teach the device according to claim 1. Chou teaches the device further comprising:
wherein the elongation-resistant fiber is disposed within a wall of the delivery tube ([0150], reinforcement fiber 801 incorporated within a wall of distal luminal portion, Fig. 8B-C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include the elongation-resistant fiber in the wall of the delivery tube. Doing so would prevent elongation of a reinforcement layer, as recognized by Chou [0150].
Regarding claim 8, Tuval and Chou teach the device according to claim 7. Chou teaches the device further comprising:
wherein the delivery tube comprises a braid, and wherein the elongation-resistant fiber is threaded through the braid ([0105], reinforcement layer can be a structure such as a braid).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include a braid in the delivery tube. Doing so would provide increased torqueability, as recognized by Chou [0107].
Regarding claim 9, Tuval and Chou teach the device according to claim 1. Tuval teaches the device further comprising:
wherein the device comprises a blood pump configured to pump blood of the subject from the left ventricle ([0343], blood pump that includes impeller 50 is disposed within subject’s left ventricle/configured to pump blood, Fig. 5B), and wherein the apparatus comprises a left-ventricular assist device ([0010], ventricular assist device disposed within left ventricle) comprising the device and the delivery tube (Fig. 5B, outer tube 142 and impeller 50).
Tuval does not teach that the apparatus comprises an elongation-resistant fiber.
Chou teaches a catheter system for insertion into a cerebral vessel of a patient [0022], further comprising:
wherein the apparatus comprises the elongation-resistant fiber ([0150], reinforcement fiber 801 incorporated within a wall of distal luminal portion, Fig. 8B-C).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include the elongation-resistant fiber. Doing so would prevent elongation of a reinforcement layer, as recognized by Chou [0150].
Regarding claim 10, Tuval and Chou teach the device according to claim 9. Tuval teaches the device further comprising:
wherein the left-ventricular assist device further comprises a drive cable, which is distally coupled to the blood pump and passes through the delivery tube ([0312], drive cable 130 disposed within first outer tube 140 that is disposed within a second outer tube 142, Fig. 10A).
Regarding claim 11, Tuval and Chou teach the device according to claim 9. Tuval teaches the device further comprising:
wherein the left-ventricular assist device further comprises a pump-outlet tube coupled to the delivery tube ([0353], second outer tube 142 is typically disposed within tube 24, Fig. 17A),
wherein the blood pump is disposed at least partly within the pump-outlet tube ([0224], impeller 50 that pumps blood within tube 24, Fig. 1C)
and wherein the pump-outlet tube is configured to curve within the left ventricle while the blood pump pumps the blood from the left ventricle through the pump-outlet tube ([0490], a portion of the tube becomes curved while pump pumps blood).
Regarding claim 12, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein the delivery tube is configured to curve, and wherein the pump-outlet tube is configured to curve by virtue of the delivery tube curving ([0394], outer tube 140 and/or 142 causes the tube 24 to assume curved shape).
Regarding claim 13, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein the blood pump is disposed at least partly within a distal portion of the pump-outlet tube ([0289], impeller 50 disposed in distal-most portion of tube 24), and wherein a proximal portion of the pump-outlet tube is configured to curve ([0490], a portion of the tube becomes curved while pump pumps blood).
Regarding claim 14, Tuval and Chou teach the device according to claim 11. Chou teaches the device further comprising:
wherein a circumferential angle between the elongation-resistant fiber and a circumferential position on the pump-outlet tube at an inside of the curve is between -10 and 10 degrees ([0150], fiber 801 is captured under reinforcement layer 803 that is within the distal luminal portion 222 of the catheter 200, Figs. 8B-C, 2A).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include a circumferential angle between -10-10 degrees between the elongation-resistant fiber and the pump-outlet tube. Doing so would allow for the body of the device to navigate the bends of the vasculature, as recognized by Chou [0100].
Regarding claim 15, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein the pump-outlet tube is configured to curve by virtue of being pre-shaped ([0392], tube 24 is pre-shaped such that it is curved).
Regarding claim 16, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein the pump-outlet tube is shaped to define multiple openings arranged in a non-axisymmetric arrangement ([0396], inlet and outlet openings 108, 109 can be non-axisymmetric and cause tube to curve, Figs. 25A-C)
and wherein the pump-outlet tube is configured to curve by virtue of the blood flowing through the openings ([0396], as blood flows, pressure changes cause tube to curve).
Regarding claim 18, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein while the delivery tube traverses the aortic arch, the pump-outlet tube curves away from a posterior wall of the left ventricle ([0392], curving away from posterior wall of left ventricle).
Tuval does not teach that the elongation-resistant fiber biases the orientation of the delivery tube.
Chou teaches a catheter system for insertion into a cerebral vessel of a patient [0022], further comprising:
the elongation-resistant fiber biases the orientation of the delivery tube ([0150]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include an elongation-resistant fiber that biases the orientation of the delivery tube. Doing so would prevent elongation, as recognized by Chou [0145].
Regarding claim 19, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein while the delivery tube traverses the aortic arch, the pump-outlet tube curves away from a septal wall of the left ventricle ([0392], curving away from septal wall of left ventricle).
Tuval does not teach that the elongation-resistant fiber biases the orientation of the delivery tube.
Chou teaches a catheter system for insertion into a cerebral vessel of a patient [0022], further comprising:
the elongation-resistant fiber biases the orientation of the delivery tube ([0150]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include an elongation-resistant fiber that biases the orientation of the delivery tube. Doing so would prevent elongation, as recognized by Chou [0145].
Regarding claim 20, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein while the delivery tube traverses the aortic arch, the pump-outlet tube curves toward an apex of the left ventricle ([0392], curving toward the apex of the left ventricle).
Tuval does not teach that the elongation-resistant fiber biases the orientation of the delivery tube.
Chou teaches a catheter system for insertion into a cerebral vessel of a patient [0022], further comprising:
the elongation-resistant fiber biases the orientation of the delivery tube ([0150]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include an elongation-resistant fiber that biases the orientation of the delivery tube. Doing so would prevent elongation, as recognized by Chou [0145].
Regarding claim 21, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein while the delivery tube traverses the aortic arch, the pump-outlet tube curves away from a septal wall of the left ventricle ([0392], curving away from septal wall of left ventricle).
Tuval does not teach that the elongation-resistant fiber biases the orientation of the delivery tube.
Chou teaches a catheter system for insertion into a cerebral vessel of a patient [0022], further comprising:
the elongation-resistant fiber biases the orientation of the delivery tube ([0150]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include an elongation-resistant fiber that biases the orientation of the delivery tube. Doing so would prevent elongation, as recognized by Chou [0145].
Regarding claim 22, Tuval and Chou teach the device according to claim 11. Tuval teaches the device further comprising:
wherein the blood pump comprises a tip portion that is disposed distally from the pump-outlet tube and curves within a plane ([0382], distal tip portion 120 curves, Fig. 22B).
Tuval discloses the distal tip portion curves within a plane as desired, but does not explicitly disclose a range of 25-65 degrees. Fig. 25 A appears to disclose such a span, but the Examiner notes the drawings are not necessarily to scale. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to limit the angle to between 25 and 65 degrees, 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.
Tuval does not teach an elongation-resistant fiber within the delivery tube.
Chou teaches a catheter system for insertion into a cerebral vessel of a patient [0022], further comprising:
the elongation-resistant fiber within the delivery tube ([0150]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval to incorporate the teachings of Chou to include an elongation-resistant fiber within the delivery tube. Doing so would prevent elongation, as recognized by Chou [0145].
Regarding claim 23, Tuval and Chou teach the device according to claim 22. Tuval teaches the device further comprising:
wherein the angle is between 35 and 55 degrees (Fig. 25A).
Regarding claim 25, Tuval and Chou teach the device according to claim 22. Tuval teaches the device further comprising:
wherein the tip portion comprises:
a straight segment (proximal straight portion of distal tip element 107) that defines a longitudinal axis ([0382], longitudinal axis 348, Fig. 22A-B); and
a curved segment that is distal to the straight segment and curves in a first direction with respect to the longitudinal axis before passing through an inflection point and curving in a second direction with respect to the longitudinal axis, such that the curved segment defines a bulge on one side of the longitudinal axis ([0382], curves towards longitudinal axis then away to define bulge 351).
Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US Pre-Grant Publication 2020/0237985) in view of Chou (US Pre-Grant Publication 2020/0289136), further in view of Madrid et al. (US Pre-Grant Publication 2016/0206425), hereinafter ‘Madrid’.
Regarding claim 17, Tuval and Chou teach the device according to claim 11, but do not teach the limitations of claim 17.
Madrid teaches a catheter delivery system ([0006], Fig. 38B), further comprising:
wherein the left-ventricular assist device further comprises one or more bands bonded to an outer wall of the pump-outlet tube ([0228], Fig. 54, catheter shaft 1050 comprises a plurality of flexible locking sections 1052),
and wherein the pump-outlet tube is configured to curve by virtue of the bands being bonded to the outer wall ([0228], flex and bend).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval and Chou to incorporate the teachings of Madrid to include bands bonded to the outer wall of the pump-outlet tube to cause it to curve. Doing so would allow for the device to navigate through the anatomy, as recognized by Madrid [0228].
Claim(s) 24 is rejected under 35 U.S.C. 103 as being unpatentable over Tuval et al. (US Pre-Grant Publication 2020/0237985) in view of Chou (US Pre-Grant Publication 2020/0289136), further in view of Singru (US Pre-Grant Publication 2021/0085955), hereinafter ‘Singru’.
Regarding claim 24, Tuval and Chou teach the device according to claim 22 and claim 24. Additionally, Singru teaches a ventricular decompression and assisting apparatus (100), further
comprising:
wherein the tip portion has a pigtail shape (Fig. 4, [0076]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tuval and Chou to incorporate the teachings of Singru to include the tip portion having a pigtail shape. Doing so would minimize bleeding and puncturing, as recognized by Singru [0143].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Romero et al. (US Pre-Grant Publication 2016/0064117) teaches a driveline cable.
Kearsley et al. (US Pre-Grant Publication 2015/0031937) teaches a modular driveline.
MacDonald et al. (US Pre-Grant Publication 2010/0152523) teaches a mechanical cardiac assist device.
Tartaglia et al. (US Pre-Grant Publication 2003/0171650) teaches an endoscope.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH L OKONAK whose telephone number is (571)272-1594. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.L.O./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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