DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed June 4, 2026 has been entered. Claims 2, 8 have been amended. Claim 1 is canceled. Claims 14-21 are new. Claims 2-7 are withdrawn. Currently, claims 8-21 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 6-7, filed June 4, 2026, with respect to the rejection(s) of claim(s) 8 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Herman et al. (US 2019/0321049).
Terminal Disclaimer
The terminal disclaimer filed on June 4, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 11,351,359; 11,471,665; 11,697,017; 12,017,060 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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) 8-9, 11, 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delgado, III (US 2006/0036127) in view of Herman et al. (US 2019/0321049).
Regarding claim 8, Delgado, III discloses a blood flow assist system comprising: a pump 110 comprising: an impeller 115 disposed in a pump housing (fig. 4); and a strut 121 comprising a first end disposed at or coupled with the pump housing (fig. 4), a second end 122 opposite the first end, and an inflection zone disposed between the first end and the second end, the second end elastically deflectable toward and away from a longitudinal axis of the pump (fig. 3-4), a free state of the strut spacing the second end thereof away from the longitudinal axis of the pump (fig. 4), the second end of the strut configured to engage a wall of the blood vessel ([0038]); and a sheath 140 comprising an inner wall configured to be disposed over the pump and to deflect the strut between the first and second end thereof (fig. 3), wherein the inflection zone is at a first distance from the first end and a second distance from the second end, the first distance less than the second distance (fig. 3).
Delgado, III does not expressly disclose wherein the inflection zone is configured such that when the strut is deflected by the inner wall of the sheath, the second end of the strut is spaced away from the inner wall of the sheath. Herman et al. teaches struts 92 of a similar purpose of anchoring a device to tissue can comprise a shape having a first end and a second end, and an inflection zone (curved portion of the strut) disposed between the first end and the second end, the second end elastically deflectable toward and away from a longitudinal axis of the device (fig. 3a-b), a free state of the strut spacing the second end thereof away from the longitudinal axis of the device (fig. 3a), the second end of the strut configured to engage tissue; wherein the inflection zone is configured such that when the strut is deflected by the inner wall of the sheath, the second end of the strut is spaced away from the inner wall of the sheath (fig. 3c). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the strut of Delgado, III to comprise a curvature at the inflection zone as taught by Herman et al. such that when the strut is deflected by the inner wall of the sheath, the second end of the strut is spaced away from the inner wall of the sheath in order to allow a configuration that facilitates sliding the sheath over the struts and maintains a constant resistance to movement of sheath over struts, thereby facilitating control by the operating physician ([0381]), and further to select an inflection zone location that is a first distance from the first end and a second distance from the second end, the first distance less than the second distance since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 9, Delgado, III discloses wherein the second end of the strut comprises a hook 123 (fig. 3-4).
Regarding claim 11, Delgado, III discloses further comprising a tether 117 coupled with a first end of the pump, the tether comprising an electrical conveyance configured to convey current to and from a source (“battery” [0041]) connectable to a proximal end of the electrical conveyance ([0040]).
Regarding claim 14, Delgado, III in view of Herman et al. discloses the strut comprises a first segment extending from the first end and a second segment between the first segment and the second end of the strut, the second segment angled relative to the first segment, the second segment longer than the first segment (see figure below).
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Regarding claim 15, Delgado, III in view of Herman et al. discloses wherein the second segment includes a first portion extending from and angled relative to the first segment and a second portion extending from and angled relative to the first portion (see figure below).
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Regarding claim 16, Delgado, III in view of Herman et al. disclose wherein the strut comprises a first segment extending from the first end, a second segment extending from the first segment at an angle relative to the first segment, and a third segment extending from the second segment at an angle relative to the second segment (see figure below).
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Claim(s) 10, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delgado, III (US 2006/0036127) in view of Herman et al. (US 2019/0321049) and further in view of Najafi et al. (US 2011/0303229).
Regarding claim 10, Delgado, III does not expressly disclose wherein the inflection zone comprises an S-connection between a first span of the strut and a second span of the strut, the first span and the second span being disposed along parallel trajectories. Najafi et al. teaches a similar device comprising struts 26 implanted within a blood vessel ([0038]) wherein the inflection zone comprises an S-connection between a first span of the strut and a second span of the strut, the first span and the second span being disposed along parallel trajectories ([0021]; see figure below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Delgado, III to shape the arms in the manner taught by Najafi et al. to allow for smooth corners and edges for vessel contact ([0030]).
Regarding claim 12, Delgado, III does not expressly disclose convex contact pads at a distal portion of the strut, the convex contact pads configured to contact a blood vessel to maintain spacing of the pump housing from a blood vessel wall in which the pump housing is disposed. Najafi et al. discloses convex contact pads 36 ([0038]) at a distal portion of the strut, the convex contact pads configured to contact a blood vessel wall to maintain spacing of the device housing from a blood vessel wall ([0024]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include convex contact pads at the ends of the struts as taught by Najafi et al. in order to help navigate blood vessel curvature without causing damage to the walls ([0038]).
Regarding claim 13, Delgado, III does not expressly disclose wherein a major lateral dimension of the at least a portion of the strut is less than a major lateral dimension of the pump housing. Najafi et al. teaches a major lateral dimension of the at least a portion of the strut is less than a major lateral dimension of the device housing (see figure below). It would have been obvious to one of ordinary skill in the before the effective filing date of the claimed invention to make the lateral dimension of the strut less than a lateral dimension of the housing for an easy, low-profile deployment ([0018-0019], [0031]). The examiner considers the lateral dimension of the strut in closed position is necessarily less than the lateral dimension of the housing because it must fit within the housing during deployment. Furthermore, the claim only requires “a portion” of the strut to be less than the lateral dimension of the housing in which case even the tiniest portion of the strut would read on the claim.
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Claim(s) 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delgado, III (US 2006/0036127) in view of in view of Herman et al. (US 2019/0321049) and Tuseth et al. (US 2018/0311421).
Regarding claim 17, Delgado, III discloses a blood flow assist system comprising: a pump 110 comprising: an impeller 115 disposed in a pump housing (fig. 4); and a strut 121 comprising a first end disposed at or coupled with the pump housing (fig. 4), a second end 122 opposite the first end, and an inflection zone disposed between the first end and the second end, the second end elastically deflectable toward and away from a longitudinal axis of the pump (fig. 3-4), a free state of the strut spacing the second end thereof away from the longitudinal axis of the pump (fig. 4), the second end of the strut configured to engage a wall of the blood vessel ([0038]); and a sheath 140 comprising an inner wall configured to be disposed over the pump and to deflect the strut between the first and second end thereof (fig. 3).
Delgado, III does not expressly disclose wherein the inflection zone is configured such that when the strut is deflected by the inner wall of the sheath, the second end of the strut is spaced away from the inner wall of the sheath. Herman et al. teaches struts 92 of a similar purpose of anchoring a device to tissue can comprise a shape having a first end and a second end, and an inflection zone (curved portion of the strut) disposed between the first end and the second end, the second end elastically deflectable toward and away from a longitudinal axis of the device (fig. 3a-b), a free state of the strut spacing the second end thereof away from the longitudinal axis of the device (fig. 3a), the second end of the strut configured to engage tissue; wherein the inflection zone is configured such that when the strut is deflected by the inner wall of the sheath, the second end of the strut is spaced away from the inner wall of the sheath (fig. 3c). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the strut of Delgado, III to comprise a curvature at the inflection zone as taught by Herman et al. such that when the strut is deflected by the inner wall of the sheath, the second end of the strut is spaced away from the inner wall of the sheath in order to allow a configuration that facilitates sliding the sheath over the struts and maintains a constant resistance to movement of sheath over struts, thereby facilitating control by the operating physician ([0381]), and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Delgado, III does not expressly disclose wherein the second end of the strut comprises a contact pad having a width larger than an immediately adjacent expanse of the strut. Tuseth et al. teaches it is known in the art to provide a contact pad 306 at a distal end of a strut 302, the shape of the contact pad 306 having a width larger than an immediately adjacent expanse of the strut (fig. 3). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Delgado, III to include a contact pad sized and shaped like the contact pad taught by Tuseth et al. in order provide a larger surface area for contacting the tissue, and since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claim 18, Delgado, III does not expressly disclose wherein the inflection zone is a first distance from the first end and a second distance from the second end, the first distance less than the second distance. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select an inflection zone location that is a first distance from the first end and a second distance from the second end, the first distance less than the second distance since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Regarding claims 19-21, see the rejection of claims 14-16, respectively.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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