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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract recites, “Apparatus and methods are described…”, in which the phrase, “are described” is considered implied phraseology and should be avoided. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 6 is objected to because of the following informalities:
Claim 6 recites, “…wherein the drive cable and hollow shaft are shaped to define a continuous lumen”. The term, “hollow shaft” is not explicitly mentioned in claim 5, and is interpreted to refer to claim 5’s axial shaft. It is then suggested by the Examiner that claim 6 explicitly refers the hollow shaft as the axial shaft. Appropriate correction is required.
5. The apparatus according to claim 1, wherein the axial shaft is hollow.
6. The apparatus according to claim 5, wherein the drive cable and hollow shaft are shaped to define a continuous lumen.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-2, 4-6 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Tuval (US 20200237986 A1 – hereinafter Tuval).
Re. claim 1, Tuval teaches an apparatus, comprising:
an axial shaft configured for insertion into, and rotation within, a body of a subject (figure 2D, axial shaft 92);
a delivery tube, configured to extend to the axial shaft, from outside the subject’s body, while the axial shaft is within the subject’s body (figure 10A, outer tube 142);
an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject (figure 2D, impeller 50);
proximal and distal radial bearings surrounding the axial shaft, proximally and distally to the impeller respectively, the proximal and distal radial bearings being configured to radially stabilize the axial shaft while the axial shaft rotates (figure 4, proximal bearing 116 and distal bearing 118);
a proximal bearing housing that houses the proximal radial bearing and is coupled to the delivery tube (figure 5A, coupling portion 31 which couples to the proximal bearing 116);
and a drive cable configured to rotate the axial shaft while extending through the delivery tube, the drive cable being coupled to the axial shaft within the proximal bearing housing (figure 5A, drive cable 130).
Re. claim 2, Tuval further teaches wherein the proximal bearing housing is configured to inhibit bending of the drive cable within the proximal bearing housing (figure 5A, coupling portion 31 which couples to the proximal bearing 116 to prevent bearing 116 from bending).
Re. claim 4, Tuval further teaches wherein the impeller is configured to be placed in a left ventricle of the subject and to pump blood of the subject from the left ventricle to an aorta of the subject (paragraph 0010 – “The impeller, the axial shaft and the frame are disposed within a distal portion of the tube inside the subject's left ventricle”), and wherein the proximal bearing housing is configured to be placed within the subject’s left ventricle (figure 10A shows the ventricular assist device and its parts traversing through the heart chambers; paragraph 0321 – “Typically, when the impeller and the frame are disposed in the subject's left ventricle, the first and second coupling portions are decoupled from each other, such that the proximal end of impeller is able to move with respect to frame 34 and proximal bearing 116”).
Re. claim 5, Tuval further teaches wherein the axial shaft is hollow (fluid flows through the axial shaft, paragraph 0334 – “…such that at least some fluid flows all the way to the distal end of the axial shaft”).
Re. claim 6, Tuval further teaches wherein the drive cable and hollow shaft are shaped to define a continuous lumen (figure 5A shows the drive cable 130 and axial shaft 92 coupled to form a continuous lumen).
Claim Rejections - 35 USC § 103
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (US 20200237986 A1 – hereinafter Tuval).
Re. claim 3, Tuval teaches the proximal bearing housing as stated above (figure 5A, coupling portion 31 which couples to the proximal bearing 116), and distal end of the drive cable (figure 5A, drive cable 130 includes a proximal and distal end), but does not explicitly teach a radial separation between the proximal bearing housing and a distal end of the drive cable, which is within the proximal bearing housing, is less than 2 mm.
However, despite the recitation of the essential working elements as claimed, a difference is found with respect to the layout and arrangement of elements. The difference in the layout and arrangement of the essential working elements is not considered to comprise a critical advantage to the layout of elements disclosed by Tuval, and thus is not considered to constitute a patentable difference. Furthermore, since Tuval demonstrates the capability of housing each of the working elements (proximal bearing housing, drive cable), then the architecture in which the elements are arranged is not deemed critical. This difference, wherein the only difference being the arrangement and location of essential working elements, has been held by the reviewing courts as being obvious to one of ordinary skill in the art since it is motivated by choice in design and routine skill (In re Japikse, 86 USPQ 70), see MPEP 2114.04. The location of each element is then further motivated by choice in design dictated by the limited available space.
Claim(s) 7, 9-10, 12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (US 20200237986 A1 – hereinafter Tuval) in view of Eidenschink (US 20070244550 A1 – hereinafter Eidenschink).
Re. claim 7, Tuval teaches wherein the drive cable comprises a plurality of coiled wires (paragraph 0330 – “As described hereinabove (with reference to FIG. 10B) typically the drive cable includes a plurality of coiled wire”),
And wherein the axial shaft is hollow (fluid flows through the axial shaft, paragraph 0334 – “…such that at least some fluid flows all the way to the distal end of the axial shaft”).
Tuval does not explicitly teach wherein the apparatus further comprises a coupling tube shaped to define multiple coupling-tube pores, wherein a distal end of the drive cable and a proximal end of the axial shaft, which proximal end is shaped to define multiple shaft pores, AND wherein the apparatus further comprises a bonding material.
Eidenschink teaches a similar tubular medical device which facilitates blood flow (paragraph 0051), and further teaches the device comprises a polymeric filter tube 310 comprising pores/holes in a first portion 312, placed on the proximal and distal end of the filter tube 310, to allow blood flow through (paragraph 0051 – “Blood can flow through the holes in first portion 312 of the shape memory polymer filter tube 310”). Eidenschink further teaches the known technique of using bonding material to adhere a sleeve to an outer tubing (paragraph 0032 – “As shown, sleeve 1 is secured to outer member 60 (e.g., by laser bonding or adhesive bonding)…”).
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Therefore, 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 ventricular assist device of Tuval, to incorporate the polymeric filter tube and bonding material as taught by Eidenschink since such modification would predictably result in permitting fluid to pass while retaining particulate matter (Eidenschink paragraph 0050).
The combined invention of Tuval and Eidenschink not teach the drive cable and axial shaft are disposed within opposing ends of the coupling tube, AND the bonding material bonds the drive cable to the shaft by virtue of being solidified between the coiled wires and in the proximal end of the axial shaft opposite the coupling-tube pores and shaft pores.
However, despite the recitation of the essential working elements as claimed, a difference is found with respect to the layout and arrangement of elements. The difference in the layout and arrangement of the essential working elements is not considered to comprise a critical advantage to the layout of elements disclosed by the combined invention of Tuval and Eidenschink, and thus is not considered to constitute a patentable difference. Furthermore, since the combined invention of Tuval and Eidenschink demonstrates the capability of housing each of the working elements (drive cable, axial shaft, coupling tube and bonding material), then the architecture in which the elements are arranged is not deemed critical. This difference, wherein the only difference being the arrangement and location of essential working elements, has been held by the reviewing courts as being obvious to one of ordinary skill in the art since it is motivated by choice in design and routine skill (In re Japikse, 86 USPQ 70), see MPEP 2114.04. The location of each element is then further motivated by choice in design dictated by the limited available space.
Re. claim 9, the combined invention of Tuval and Eidenschink (hereinafter the combined invention) further teaches wherein, at the distal end of the drive cable, the coiled wires are merged together (Tuval paragraph 0311 – “For some applications, the drive cable includes a plurality of wires 134 (as shown in FIG. 10B) that are disposed in a tightly-coiled configuration in order to impart sufficient strength and flexibility to the drive cable”).
Re. claim 10, the combined invention further teaches wherein the drive cable and hollow shaft are shaped to define a continuous lumen (Tuval figure 5A shows the drive cable 130 and axial shaft 92 coupled to form a continuous lumen).
Re. claim 12, the combined invention further teaches wherein the coupling tube is polymeric (Eidenschink paragraph 0051 – “Blood can flow through the holes in first portion 312 of the shape memory polymer filter tube 310”).
Re. claim 15, the combined invention further teaches wherein the coupling tube is compliant so as to conform both to the first outer diameter and to the second outer diameter (Eidenschink teaches a polymer filter tube 310, which would be made to be flexible to conform to differing shapes).
The combined invention further teaches the drive cable and axial shaft, as stated above in claim 1, but does not explicitly teach wherein a first outer diameter of the distal end of the drive cable is greater than a second outer diameter of the proximal end of the axial shaft.
However, it is held that limitations relating to the size of the essential elements are not sufficient to patentably distinguish over the prior art, as per In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955), see MPEP 2114.04. In the instant case, the combined invention sufficiently teaches the drive cable and axial shaft as stated above, but differ in their diameters, and subsequently changing their diameters would not produce and new or unexpected result, nor change operation of the device in pumping blood. Therefore, 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 combined invention’s outer diameter of the distal end of the drive cable, to be greater than a second outer diameter of the proximal end of the axial shaft, since such modification would predictably result in creating strong structural support to the device’s parts.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (US 20200237986 A1 – hereinafter Tuval) in view of Eidenschink (US 20070244550 A1 – hereinafter Eidenschink), and in further view of Scheckel (US 20200197585 A1 – hereinafter Scheckel) and Marquis (AU 2008219653 A1 – hereinafter Marquis).
Re. claim 8, the combined invention of Tuval and Eidenschink (hereinafter the combined invention) teaches the radial bearings as stated above in claim 1, but does not explicitly teach wherein the radial bearing comprises a ceramic radial bearing.
Scheckel teaches a similar blood pump device (figure 2),
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And further teaches the known element of ceramic bearings (paragraph 0005 – “Furthermore, additional bearings, for instance made of ceramics, can be provided inside the elongated polymer part”; paragraph 0031 – “The bearing spiral sleeve is preferably made of metal, for instance made of MP35N® or 35NLT®, or made of ceramics”). Therefore, 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 radial bearing material of the combined invention, to incorporate the ceramic bearing material as taught by Scheckel since such modification would predictably result in creating strong structural support to the device’s parts.
The newly combined invention further teaches the coupling tube as stated above in claim 7 (Eidenschink paragraph 0051 – “Blood can flow through the holes in first portion 312 of the shape memory polymer filter tube 310”), does not explicitly teach wherein the coupling tube is a ceramic coupling tube that is configured to rotate within the radial bearing during rotation of the axial shaft.
Marquis teaches a similar blood pump device (abstract – “One aspect of an intravascular ventricular assist device is an implantable blood pump…”), and further teaches the known element of a ceramic tubing (paragraph 0031 – “Housing 12 is a ceramic tube…”). Therefore, 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 filter tube of the newly combined invention, to incorporate the ceramic tube material as taught by Marquis, since such modification would predictably result in creating strong structural support to the device’s parts.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tuval (US 20200237986 A1 – hereinafter Tuval) in view of Eidenschink (US 20070244550 A1 – hereinafter Eidenschink), and in further view of Franano (US 20170258981 A1 – hereinafter Franano).
Re. claim 11, the combined invention of Tuval and Eidenschink (hereinafter the combined invention) teaches the bonding material as stated above in claim 7, but does not explicitly teach wherein the bonding material comprises a polymer.
Franano teaches a similar blood pump device (abstract – “The present invention relates to a rotary blood pump…”), and further teaches the known element of a polymeric bonding material (“the molten polyurethane”, paragraph 0190). Therefore, 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 bonding material of combined invention, to incorporate the ceramic tube material as taught by Marquis, since such modification would predictably result in creating strong structural support to the device’s parts.
Allowable Subject Matter
Claims 13-14 and 16-23 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.
The following is a statement of reasons for the indication of allowable subject matter: the prior art of record does not reasonably anticipate and/or render obvious to a drive cable and its first outer diameter of the distal end of the drive cable is greater than a second outer diameter of the proximal end of the axial shaft, wherein the apparatus further comprises an adaptor tube, which is shaped to define multiple adaptor-tube pores, over the proximal end of the axial shaft, the adaptor tube adding to the second outer diameter, and wherein the bonding material is solidified opposite the adaptor-tube pores, as claimed in claim 13. Dependent claim 14 is further objected due to its dependency to claim 13.
The prior art of record does not reasonably anticipate and/or render obvious to a coupling tube having a wall shaped to define multiple tabs, wherein a distal end of the drive cable and a proximal end of the axial shaft, which proximal end is shaped to define multiple shaft pores, are disposed within opposing ends of the coupling tube, and at least some of the tabs protrude into the shaft pores, respectively, as claimed in claim 16. Dependent claims 17-23 is further objected due to its dependency to claim 16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Kiyota (US 5453076 A) teaches a cardiac assist device (abstract), and further teaches a balloon 1 structured as a tube-like piece with inflatable tabs.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anh-Khoa N. Dinh whose telephone number is (571)272-7041. The examiner can normally be reached Mon-Fri 7:00am-4:00pm EST.
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/ANH-KHOA N DINH/Examiner, Art Unit 3796