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 .
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 May 2026 has been entered.
Election/Restrictions
Newly submitted claims 45-46 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The inventions of Group I (Claims 21-26, 28-30 ,32-34, 37-40 and 42-44) and Group II (Claims 45-46) are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the combination of group I specifies a stent cage but does not require the cage configured to apply radial force sufficient to distend an inner diameter of the subject’s aorta as in group II. The subcombination of group II has separate utility such as a employing a stent cage comprising a tip, where the elements extend from the tip and expand radially as in group I.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 45-46 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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 21-26, 28-30 ,32-34, 37-40 and 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Kushwaha et al. (US 2013/0138205; hereinafter “Kushwaha”) in view of Khanal et al. (US 2014/0051908; hereinafter “Khanal”).
Regarding claim 21, Kushwaha discloses a system for assisting a subject's heart to pump blood, the system comprising: at least one circulatory assist pump comprising an impeller configured to be placed in a subject's aorta and, in operation after placement in the subject's aorta, to rotate to draw blood down the subject's aorta from the subject's heart (e.g. ¶¶ 65); and a stent cage associated with the at least one circulatory assist pump and configured to be placed with the circulatory assist pump in the subject's aorta, the stent cage configured to expand radially outward into an expanded state to affix the stent cage and the at least one circulatory assist pump in a position within the aorta for the operation of the at least one circulatory assist pump (e.g. ¶¶ 60-63), the stent cage comprising wire-like elements sized and shaped to contact and be stable against a wall of the subject's aorta in the expanded state (e.g. ¶¶ 44 – “stent 202 (and in particular the wall 204) may be defined by a metal (e.g. titanium) or other suitable material mesh tube”), the size and the shape of the wire-like elements, in the expanded state, are configured to allow an open flow of blood through the wire-like elements after placement of the system within the subject's aorta (e.g. ¶¶ 36).
Kushwaha fails to expressly disclose the cage shaped to directly contact against a wall of the subject’s aorta, where the wire-like elements are configured to encage the at least one circulatory assist pump and define areas for blood flow between the wire-like elements, wherein the stent cage further comprises a tip where the wire-like elements extend from the tip, expand radially outward relative to an impeller axis and surround the impeller. In the same field of endeavor, Khanal discloses a circulatory assist pump with a stent cage configured to directly contact against a wall of the subject’s aorta (e.g. ¶¶ 80; Fig. 2 – where the distension of the arterial wall is visible), where the wire-like elements are configured to encage the at least one circulatory assist pump and define areas for blood flow between the wire-like elements, wherein the stent cage further comprises a tip where the wire-like elements extend from the tip, expand radially outward relative to an impeller axis and surround the impeller (e.g. Fig. 4B, 9, and 10; ¶¶ 90-93 – where the examiner considers the portions of the cage wire-like elements which define gaps where flow necessarily passes through in order for the impeller to function as described), in order to effectively provide mechanical treatment of CHF. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to modify the cage of Kushwaha with a stent cage that expands to directly contact the aortic wall with wire-like elements configured to encage the at least one circulatory assist pump and define areas for blood flow between the wire-like elements, wherein the stent cage further comprises a tip where the wire-like elements extend from the tip, expand radially outward relative to an impeller axis and surround the impeller, as taught by Khanal, in order to yield the predictable results of providing a secure positioning and protection of the pump while treating a variety of additional conditions including patients suffering from CHF.
Regarding claim 30, Kushwaha teaches a method of treating a patient suffering from heart disease, the method comprising: placing into the patient's aorta a system comprising: at least one circulatory assist pump comprising an impeller, and a stent cage associated with the at least one circulatory assist pump (e.g. ¶¶ 65), which stent cage comprises wire-like elements configured to expand radially outward into an expanded state (e.g. ¶¶ 44 – “stent 202 (and in particular the wall 204) may be defined by a metal (e.g. titanium) or other suitable material mesh tube”), expanding the stent cage to the expanded state so as to contact and be stable against a wall of the subject's aorta to affix the stent cage and the a least one circulatory assist pump in a position within the patient's aorta, a size and a shape of the wire-like elements, in the expanded state, are configured to allow an open flow of blood through the wire-like elements after expansion of the stent cage within the subject's aorta (e.g. ¶¶ 60-65), and operating the impeller while the at least one circulatory assist pump is affixed in position within the patient's aorta, so to draw blood down the patient's aorta from the patient's heart (e.g. ¶¶ 36, 60-63, etc.)
Kushwaha fails to expressly disclose the cage shaped to directly contact against a wall of the subject’s aorta, where the wire-like elements are configured to encage the at least one circulatory assist pump and define areas for blood flow between the wire-like elements, wherein the stent cage further comprises a tip where the wire-like elements extend from the tip, expand radially outward relative to an impeller axis and surround the impeller. In the same field of endeavor, Khanal discloses a circulatory assist pump with a stent cage configured to directly contact against a wall of the subject’s aorta (e.g. ¶¶ 80; Fig. 2 – where the distension of the arterial wall is visible), where the wire-like elements are configured to encage the at least one circulatory assist pump and define areas for blood flow between the wire-like elements, wherein the stent cage further comprises a tip where the wire-like elements extend from the tip, expand radially outward relative to an impeller axis and surround the impeller (e.g. Fig. 4B, 9, and 10; ¶¶ 90-93 – where the examiner considers the portions of the cage wire-like elements which define gaps where flow necessarily passes through in order for the impeller to function as described), in order to effectively provide mechanical treatment of CHF. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to modify the cage of Kushwaha with a stent cage that expands to directly contact the aortic wall with wire-like elements configured to encage the at least one circulatory assist pump and define areas for blood flow between the wire-like elements, wherein the stent cage further comprises a tip where the wire-like elements extend from the tip, expand radially outward relative to an impeller axis and surround the impeller, as taught by Khanal, in order to yield the predictable results of providing a secure positioning and protection of the pump while treating a variety of additional conditions including patients suffering from CHF.
Regarding claim 23, Kushwaha discloses when the system is placed and operated in the aorta proximal and above the subject's renal arteries, the system is configured to maintain natural wall pulsatility of the subject's aorta during operation of the at least one circulatory assist pump (e.g. ¶¶ 17 – “device preferably allows the maintenance of pulsatile physiologic flow to augment the natural cardiac cycle of the heart”).
Regarding claims 24 and 32, Kushwaha discloses the system is controllable wirelessly (e.g. ¶¶ 68 – “providing a means of wireless programming”).
Regarding claims 25 and 33, Kushwaha discloses the speed of the system is controlled wirelessly (e.g. ¶¶ 20 – “control of power and settings using a near field communication system to control the power requirements and output, the timing, and/or other settings”).
Regarding claims 26 and 34, Kushwaha discloses the pump is powered wirelessly (e.g. ¶¶ 68 - power source preferably would be transcutaneously charged”).
Regarding claim 28, Kushwaha discloses the system is placed within the subject's aorta and actuates the at least one circulatory assist pump (e.g. ¶¶ 60-63).
Regarding claim 29, Kushwaha discloses the system is placed percutaneously (e.g. Abstract – “arranged for percutaneous placement the flow path”).
Regarding claim 37, Kushwaha discloses the impeller comprises a tubular casing and impeller blades are pivotally expandable and retractable relative to the tubular casing (e.g. Figs. 16-17).
Regarding claim 38, Kushwaha discloses the impeller comprises a tubular casing and impeller blades are pivotally expandable and retractable relative to the tubular casing (e.g. ¶¶ 43).
Regarding claim 39, Kushwaha discloses the impeller rotates to achieve at least 4.5 liters flow at the level of the patient’s renal arteries (e.g. ¶¶ 41 – where the flow rate would be known and targeted).
Regarding claim 40, Kushwaha discloses the system comprises multiple impellers, and the method further includes causing the multiple impellers to rotate to increase blood flow (e.g. Fig. 4, #120).
Regarding claim 42, Kushwaha discloses the stent cage comprises a tip where the stent cage conveges and shields the patient’s aortic tissue from the impeller during operation (e.g. ¶¶ 43, 60-63, etc.).
Regarding claims 43-44, Kushwaha fails to expressly disclose the stent cage being positioned at the tip of the placement catheter and the impeller being positioned within the stent cage. Khanal teaches the implantation of the stent cage as part of the tip of the placement catheter, with the impeller protected within the stent cage, prior to expanding against the aortic wall, to provide the hemodynamic circulatory assist pumping (e.g. ¶¶ 82). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to modify the placement and positioning of the impeller and stent to be protected during implantation as taught by Khanal, in order to yield the predictable results of providing a safe way of securing the pump in the most effective position in the patient’s vasculature.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kushwaha in view of Khanal, further in view of Salahieh (US 2019/0143018; hereinafter “Salahieh”). Kushwaha fails to expressly disclose the impeller has an expanded polytetrafluoroethylene (ePTFE) liner. In the same field of endeavor, Salahieh discloses the use of an expanded PTFE liner in the impeller system in order to protect both the impeller and the neighboring structures (e.g. ¶¶ 51). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of employing PTFE liners as taught by Salahieh, to improve the device of Kushwaha in the same manner.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
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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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796
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