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 Objections
Applicant is advised that should claim 1 be found allowable, claim 20 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
In claim 20, the claim contains the same limitations as claim 1, except for the preamble stating it is a ventricular assistance system. It is unclear what additional limitations are in claim 20 compared to claim 1, as claim 1 contains intended/functional use limitations directed to a ventricular assistance system and pump.
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.
Claim 18 is 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.
In claim 18, line 8, “…or, the liquid inlet…” is vague as it is unclear what the “or” phrase pertains to or is in reference to. What specific element or phrase is it an alternative language to? It is unclear what the claim is limiting.
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
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.
Claims 1, 8-10, 12, 16, 17, 19, and 20 are rejected under 35 U.S.C. 102(a1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Aboul-Hosn (6083260). Aboul-Hosn meets the claimed limitations as follows:
--a pump housing with an accommodating cavity (e.g. figure 1, elements 60, 52, 80; figures 9A-E, etc.)
--a pipeline assembly having a liquid outlet pipe in communication with the accommodating cavity (e.g. figure 1, element 20 with outlet at 22; figure 9, etc.—Note that the pump can be reversed so that element 20/22 is an outlet; col. 7, lines 1-6; col. 11, lines 40-42, etc.), with a liquid inlet in communication with the accommodating cavity (e.g. figure 1, element 30/32, etc.) that has a certain length what can extend through a ventricular wall and the outlet pipe can extend through an aortic arch into an aorta (Note that these claim limitations are functional/intended use recitations and the prior art only needs to be capable of meeting these limitations; e.g. figures 1, 12, 13, etc. showing extending through a wall; figures 14-21 showing that the lengths are capable of extending through an aortic arch into an aorta, or for claim 19 extending into a second organ, depending on how the pump is used/inserted)
--an impeller rotatably received in the accommodating cavity to enable liquid from the inlet to flow out through the outlet (e.g. figure 1, element 70, figures 7-8, etc.). While Aboul-Hosn does not call the rotor with blades and “impeller”, it meets the definition of an impeller.
In the alternative, it would have been obvious to one having ordinary skill in the art at the time the invention was made to have modified the rotor pump with blades as taught by Aboul-Hosn, with an impeller, as is well known and common knowledge in the art (mpep 2144I, 2144.03), since it would provide the predictable results of an highly efficient pumping rotor that smoothly, and/or without shear stress, move blood or fluids in the body.
For claim: 8, pump housing provided with a liquid outlet cavity connected to outlet pipe, and the liquid entering from the inlet flows into the outlet pipe through the cavity (e.g. figure 1, element 62; figure 5 area at 56; figure 9, center cavity to expel fluid such as element 160, 173, etc.); 9, see the figure below; 10, pump housing having a bottom housing (e.g. figure 1, element 80, etc.) and a top housing (e.g. figure 1, element 60, etc.) and it encloses the liquid outlet cavity (e.g. figures 5, 9, etc.); 12, see the figure below; 16, a liquid inlet pipe provided outside the liquid outlet pipe (e.g. figure 1, element 30 outside element 20, etc.); 17, an arc shaped pumped outer housing (e.g. round/arc shaped housing 60, 52, 80 in figure 1, etc.) with outlet pipe in a tangential direction to the pump housing and bent (e.g. figure 1, element 30 tangential to arc housing 52, and bent as shown by squiggly lines in figure 1, also shown in figure 12 as bent, etc.) and extends from the pump housing in a direction approaching the liquid outlet pipe (e.g. figure 1, figure 12, etc.)
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Claim 2, 5, 6, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Aboul-Hosn in view of Nishimura et al (WO 2012/165429). Aboul-Hosn discloses the claimed invention having the inlet and outlets connected to the accommodating cavity, but does not disclose using a liquid outlet pipe with a liquid inlet pipe in the outlet pipe to have a flow channel formed between the liquid inlet pipe and outlet pipe, where the inlet is exposed on an outer peripheral surface of the outlet pipe (e.g. claim 2), a plurality of inlets along a circumferential direction perpendicular to an axis of the liquid outlet pipe and are exposed from the outer peripheral surface of the liquid pipe, and the plurality of liquid inlets are in communication with the liquid inlet pipe (e.g. claim 5), the two liquid inlets are provided that are opposite to each other (claim 6), and/or the first pipe section has the inlets and is in between the second pipe section having the outlet and the pump housing, where the outer diameter of the first pipe section is greater than the second pipe section (claim 7). Nishimura discloses using a liquid outlet pipe with a liquid inlet pipe in the outlet pipe to have a flow channel formed between the liquid inlet pipe and outlet pipe, where the inlet is exposed on an outer peripheral surface of the outlet pipe (e.g. figures 3, 4, 7, 9, 12, etc.), a plurality of inlets along a circumferential direction perpendicular to an axis of the liquid outlet pipe and are exposed from the outer peripheral surface of the liquid pipe, and the plurality of liquid inlets are in communication with the liquid inlet pipe (e.g. figures 9, 11, 12, 14, etc.), the two liquid inlets are provided that are opposite to each other (e.g. figure 11/13, 21c4, 21c5, etc.), and/or the first pipe section has the inlets and is in between the second pipe section having the outlet and the pump housing, where the outer diameter of the first pipe section is greater than the second pipe section (figures 1-11, etc.) to provide a one-piece inlet and outlet cannula that can be easily inserted into the body/heart to circulate fluid. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Aboul-Hosn, with using a liquid outlet pipe with a liquid inlet pipe in the outlet pipe to have a flow channel formed between the liquid inlet pipe and outlet pipe, where the inlet is exposed on an outer peripheral surface of the outlet pipe (e.g. claim 2), a plurality of inlets along a circumferential direction perpendicular to an axis of the liquid outlet pipe and are exposed from the outer peripheral surface of the liquid pipe, and the plurality of liquid inlets are in communication with the liquid inlet pipe (e.g. claim 5), the two liquid inlets are provided that are opposite to each other (claim 6), and/or the first pipe section has the inlets and is in between the second pipe section having the outlet and the pump housing, where the outer diameter of the first pipe section is greater than the second pipe section (claim 7), as taught by Nishimura, since it would provide the predictable results of a one-piece inlet and outlet cannula that can be easily inserted into the body/heart to circulate fluid.
Allowable Subject Matter
Claims 3-4, 11, and 13-15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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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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/George R Evanisko/Primary Examiner, Art Unit 3792 9/23/26
