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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action. Please see MPEP 2004, which in part provides guidance as follows:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff ’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
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.
Claims 1-5 and 7-20 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2020/0237985 A1 to Tuval et al. (hereinafter “Tuval”).
Regarding Claims 1 and 14, Tuval teaches an apparatus/method, comprising:
a blood pump (see e.g. the abstract: “Apparatus and methods are described including manufacturing a housing for an impeller of a blood pump”), comprising:
an axial shaft (92) configured for insertion into, and rotation within, a left ventricle of a subject (see e.g. Para. 10: “The impeller, the axial shaft and the frame are disposed within a distal portion of the tube inside the subject's left ventricle”);
an impeller (50) coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood from the left ventricle (see e.g. Para. 312: “the rotational motion of the impeller (which is imparted via the axial shaft)”);
a frame (34) surrounding the impeller; and
a tip portion (107) coupled to a distal end of the frame and comprising:
a distal curved portion (see portion of 107 closer to valve 390, i.e. the more distal curve of tip portion 107), which is configured, when deployed within the left ventricle, to lie in a plane; and
a proximal curved portion (see portion of 107 closer to tube 126, i.e. the more proximal curve of tip portion 107), which is configured, when deployed within the left ventricle, to not lie in the plane (see generally FIGS. 6A-C and 22C; the curves are shown forming a loop where the tip 107 curves back over itself in a manner such that both curved portions cannot lie in the same plane) and to be curved such that, a distal end of the proximal curved portion points toward an apex of the left ventricle (see e.g. FIGS. 23A-B showing the general location of deployment relative to the apex 342 of the left ventricle).
Regarding Claim 2, Tuval further teaches a drive cable (130), wherein the axial shaft is coupled to the drive cable such that the axial shaft rotates with the drive cable (see generally FIGS. 10A-F and Para. 312, 314, 316).
Regarding Claim 3, Tuval further teaches a drive cable (130), wherein the axial shaft is a distal portion of the drive cable (see generally FIGS. 10A-F and Para. 312, 314, 316).
Regarding Claim 4, Tuval further teaches wherein the plane is a first plane, and wherein the proximal curved portion is configured, when deployed within the left ventricle, to lie in a second plane that is not parallel to the first plane (see generally FIGS. 6A-C and 22C; the curves are shown forming a loop where the tip 107 curves back over itself in a manner such that both curved portions cannot lie in the same plane, i.e. the distal tip element 107 has at least two curves that must lie in different planes).
Regarding Claims 5 and 20, Tuval further teaches wherein the tip portion is configured such that when the tip portion is deployed within the left ventricle, an angle between a distal end of the proximal curved portion and the axial shaft is between 100 and 170 degrees (see generally FIGS. 6A-C; one can choose/interpret as the “curved portion[s]” any portion of the proximal and distal curves lying along different planes; additionally see e.g. Paras. 402-403 describing a wide variety of possible angles).
Regarding Claim 7, Tuval further teaches wherein the distal curved portion is atraumatic (see e.g. Para. 385).
Regarding Claims 8 and 18, Tuval further teaches wherein the tip portion is configured such that when the tip portion is deployed within the left ventricle the distal curved portion has a pigtail shape (see e.g. Paras. 386-387).
Regarding Claims 9 and 17, Tuval further teaches wherein the tip portion is configured such that when the tip portion is deployed within the left ventricle the distal curved portion comprises: a straight segment that defines a longitudinal axis; 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 (see e.g. Paras. 386-387).
Regarding Claims 10 and 19, Tuval further teaches wherein the tip portion is configured such that when the tip portion is deployed within the left ventricle the tip portion further comprises a straight portion proximal to the proximal curved portion (see straight portion 126).
Regarding Claim 11, Tuval further teaches wherein the tip portion is configured such that when the tip portion is deployed within the left ventricle the straight portion (126) is configured to receive the axial shaft (92) while the axial shaft rotates (see e.g. Para. 287: “Axial-shaft-receiving tube 126 defines lumen 127, which is configured to receive the axial shaft”).
Regarding Claim 12, Tuval further teaches wherein the tip portion is shaped to define a lumen, which passes through the proximal curved portion and the distal curved portion (see e.g. lumen 122 in FIGS. 6A-C).
Regarding Claim 13, Tuval further teaches wherein the blood pump further comprises a valve (390) at a distal end of the distal curved portion (see e.g. FIGS. 6A-C).
Regarding Claim 15, Tuval further teaches wherein rotating the impeller comprises rotating the impeller while the distal curved portion pushes against an apex of the left ventricle (see e.g. FIGS. 23A-B).
Regarding Claim 16, wherein inserting the blood pump into the left ventricle comprises deploying the proximal curved portion within the left ventricle with the proximal curved portion curved such that, a distal end of the proximal curved portion points toward an apex of the left ventricle (see e.g. FIGS. 23A-B)
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 6 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Tuval.
Regarding Claims 6 and 21, it is unclear what is the exact size of the angle between the distal and proximal portions of tip 107 (i.e. the angle between the claimed proximal curved portion and the claimed “the plane”). As seen in e.g. FIGS. 6A-C, the tip 107 curves back over itself, i.e. it introduces some angle away from the plane of the figure, but it is just not clear whether that angle falls between 25-65 degrees. Nevertheless, it would have been obvious to one of ordinary skill in the art as of the filing date of Applicant’s invention to engage in routine experimentation to discover the optimal angle and general size and shape of the tip. See MPEP § 2144.05(II)(A)( “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”) (citing In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)). Here, there doesn’t appear to be a specific criticality to the exact range of 25-65 degrees, and in view of Tuval’s general teachings of different values for the angles of the tip (see e.g. Paras. 402-403, i.e. generally speaking a variety of tip shapes are contemplated), one skilled in the art would appreciate that different sizes and shapes of the tip would be desirable in different applications, and would thus consider it obvious to experiment with those sizes and shapes to obtain optimal values.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792