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 Arguments
Applicant’s arguments with respect to the previous rejection(s) of the claims have been fully considered but are not found persuasive.
Regarding the 112 rejection, the language in the disclosure mentioning high flow through areas in the protective cage is not equivalent to “allowing an open flow of blood…” as recited in the amended claims. In this scenario, one is specifying a specific region of the cage, while the claims are generally setting forth that the entire cage allows open flow of blood. It is suggested to amend the claim language with similar language found in the originally filed disclosure to overcome this rejection.
Regarding the 103 rejection, applicant argues that the prior art does not provide wire-like elements that are configured to encage the pump, with reference to the term “encage” being defined as “to confine in or as in a cage”. Applicant further contends that Kushwaha cannot confine the rotor in or as in a cage as that would prevent the separate introduction of the stent and rotor as disclosed. The examiner respectfully disagrees and is of the position that the prior art’s separate introduction has no bearing on this limitation/property of the invention. “To confine” is defined as “to hold within allocation” or “to keep within limits”. ¶¶ 16 of the prior art, along with the other cited areas, are clear that the pump position is limited to and held within the stent. The claims do not require that these elements are an integral one piece, that they are inserted together, or that they require additional structures which would require either of these. Accordingly, the rejections are maintained below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-26, 28-42 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In claims 21 and 30, the newly amended claim language recites “an open flow of blood between the wire-like elements”; however, this limitation in combination with the other limitation of the claim, do not appear to be supported by the disclosure as filed. The examiner as unable to find discussion or support for the flow of blood being directed between the wire-like elements of the cage. It is required that applicant indicate where support lies for this limitation or amend the claims to follow the scope of the disclosure as originally filed.
Claims 22-26, 28-29, and 31-42 are rejected under the same rationale as being dependent upon claims 21 or 30 and their limitations.
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, 23-26 and 28-42 are rejected under 35 U.S.C. 103 as being unpatentable over Kushwaha et al. (US 2013/0138205; hereinafter “Kushwaha”) in view of Rodefeld et al. (US 2011/0257462; hereinafter “Rodefeld”), further in view of Maimon et al. (US 2018/0326132; hereinafter “Maimon”).
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 allow an open flow of blood between the wire-like elements. In the same field of endeavor, Rodefeld discloses a cardiac assist pump configured to be placed against the wall of the subject’s aorta with wire-like elements configured to encage the at least one circulatory assist pump and allow an open flow of blood between the wire-like elements (e.g. Fig. 14, ¶¶ 126, 134-136). In addition, in the same field of endeavor, Maimon discloses a cardiac assist pump configured to be placed against the wall of the subject’s aorta with wire-like elements configured to encage the at least one circulatory assist pump and allow an open flow of blood between the wire-like elements (e.g. ¶¶ 51, 57, etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known use of stent cages that expand to directly contact the aortic wall with wire-like elements configured to encage the at least one circulatory assist pump and allow an open flow of blood between the wire-like elements, as taught by Rodefeld and Maimon, 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 an aneurysm.
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 allow an open flow of blood between the wire-like elements. In the same field of endeavor, Rodefeld discloses a cardiac assist pump configured to be placed against the wall of the subject’s aorta with wire-like elements configured to encage the at least one circulatory assist pump and allow an open flow of blood between the wire-like elements (e.g. Fig. 14, ¶¶ 126, 134-136). In addition, in the same field of endeavor, Maimon discloses a cardiac assist pump configured to be placed against the wall of the subject’s aorta with wire-like elements configured to encage the at least one circulatory assist pump and allow an open flow of blood between the wire-like elements (e.g. ¶¶ 51, 57, etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known use of stent cages that expand to directly contact the aortic wall with wire-like elements configured to encage the at least one circulatory assist pump and allow an open flow of blood between the wire-like elements, as taught by Rodefeld and Maimon, 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 an aneurysm.
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 31, Kushwaha discloses the patient is suffering from heart failure (e.g. ¶¶ 14 – “use in either severe left ventricular failure of severe right ventricular failure”).
Regarding claim 35, Kushwaha discloses a tip, wherein, in the expanded state, the wire-like elements extend from the tip, expand radially outward relative to an impeller axis, and surround the impeller (e.g. ¶¶ 43)
Regarding claim 36, Kushwaha discloses the system further comprises a tip, and wherein, in the expanded state, the wire-like elements extend from the tip, expand radially outward relative to an impeller axis, and surround the impeller (e.g. ¶¶ 20).
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 subject'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 claims 41-42, Kushwaha discloses the stent cage comprises a tip where the stent cage conveges and shields the aortic tissue from the impeller during operation (e.g. ¶¶ 43, 60-63, etc.).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Kushwaha in view of Rodefeld, further in view of Maimon, 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
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 extension fee 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 date of this final action.
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