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 .
Election/Restrictions
Applicant’s election without traverse of invention I, Species ii and Species a in the reply filed on 3/30/26 is acknowledged.
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.
(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 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by EP 2922486 to Shuman et al. (hereinafter Shuman).
Regarding Claim 1, an interpretation of discloses an apparatus (apparatus for creating mechanically-based heat generation for tissue treatment and clinical applications: see paragraph 4), comprising:
a drive-cable-bearing tube ("catheter body" 110), configured for insertion into a body of a subject and comprising one or more inwardly-facing ceramic portions ("internal surface" of "catheter body" 110; "ceramic coatings": see paragraph 13);
a drive cable ("drive wire" 140) comprising one or more outwardly-facing ceramic portions ("exterior surface" of "drive wire" 140; "ceramic coatings": see paragraph 13) and configured to:
pass through the drive-cable-bearing tube (110) such that the outwardly-facing ceramic portions ("exterior surface" of "drive wire" 140) are aligned with the inwardly-facing ceramic portions ("internal surface" of "catheter body" 110),
couple to an intracorporeal device ("thermally conductive catheter tip" 170 = "friction producing plug" 130 + "catheter high friction material" 160) at a distal end of the drive-cable-bearing tube (110), and
rotate ("rotational": see paragraph 11) within the drive-cable-bearing tube (110), thereby rotating the intracorporeal device (130), while the outwardly-facing ceramic portions ("exterior surface" of "drive wire" 140) are aligned with the inwardly-facing ceramic portions ("internal surface" of "catheter body" 110).
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.
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.
Claim(s) 1-2, 5, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190209756 to Yuval et al. (hereinafter Yuval) in view of EP 3858398 to Skrzypczak et al. using the related US PG Pub US 20230049460 (hereinafter Skr) for paragraph numbers.
Regarding Claim 1, an interpretation of Yuval discloses an apparatus, comprising:
a drive-cable-bearing tube ([0504], [0517], Figs. 10A, 12-13 see also [0588]), configured for insertion into a body of a subject and for passing through an aorta of the subject ([0445]-[0446], [0504], [0517], Figs. 1B, 10A, 12-13 see also [0588]) and comprising one or more inwardly facing friction reduction elements at a section of the drive-cable-bearing tube that is configured to sit within an aortic arch of the subject ([0517] including “friction-reduction elements 170 disposed around at least a portion of the drive cable”, [0518] including “For some applications, the friction-reduction elements are disposed between drive cable 130 and outer tube 142 substantially along the full length of drive cable 130 and outer tube 142. Alternatively, the friction-reduction elements are disposed between drive cable 130 and outer tube 142 at locations at which drive cable 130 and outer tube 142 are configured to be substantially curved, e.g., at the location at which drive cable 130 and outer tube 142 are disposed within the aortic arch,”, [0519], Figs. 10A, 12-13 see also [0588]; Fig. 12 for example shows an larger diameter wall of ball bearing casing attached to the tube and the inner wall connected with the drive cable);
a drive cable ([0448], [0517], Figs. 7, 10A, 12-13 see also [0588]) comprising one or more outwardly-facing friction reduction elements ([0517]-[0519], Figs. 10A, 12-13 see also [0588]; Fig. 12 for example shows an larger diameter wall of ball bearing casing attached to the tube and the inner wall connected with the drive cable) and configured to:
pass through the drive-cable-bearing tube ([0517]-[0519], Figs. 10A, 12-13 see also [0588]) such that the outwardly-facing friction reduction elements are aligned with the inwardly-facing friction reduction elements ([0517]-[0519], Figs. 10A, 12-13 see also [0588]; Fig. 12 for example shows an larger diameter wall of ball bearing casing attached to the tube and the inner wall connected with the drive cable),
couple to an intracorporeal device at a distal end of the drive-cable-bearing tube ([0504], Figs. 11C-E, 12-13 see also [0588]), and
rotate within the drive-cable-bearing tube, thereby rotating the intracorporeal device ([0504], Figs. 11C-E, 12-13 see also [0588]; drive cable makes impeller rotate via axial shaft while the drive cable bearing tube (ie first and/or second outer tube) remains stationary), while the outwardly-facing friction reduction elements are aligned with the inwardly- facing friction reduction elements ([0517]-[0519], Figs. 10A, 12-13 see also [0588]; Fig. 12 for example shows an larger diameter wall of ball bearing casing attached to the tube and the inner wall connected with the drive cable).
An interpretation of Yuval may not explicitly disclose the inward facing and outward facing friction reduction elements are ceramic portions.
However, in the same field of endeavor (medical devices), Skr teaches the inward facing and outward friction reduction elements are ceramic portions ([0011] including “Preferably, at the location where the at least one outer layer of the drive shaft is absent or thinned, a bearing sleeve surrounds the at least one inner layer or the thinned at least one outer layer and said bearing sleeve forms an inner surface”, [0015], [0018] including “the bearing sleeve and/or the outer bearing ring comprises one or more ceramic and/or metal”, [0113]-[0114] including “The bearing sleeve 30 is rotatably supported in the outer bearing ring 32 which, in turn, is fixed in the catheter or in a proximal end of the housing”, Figs. 9A-10B) .
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified friction reduction elements as discussed by Yuval to include the opposing friction reduction elements to be ceramic as recited by Skr because it provides low friction with high durability ([0031]). Alternatively and separately, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to combine modified friction reduction elements as discussed by Yuval to include the opposing friction reduction elements to be ceramic as recited by Skr because it is combining prior art elements (the recitation of using friction reducing elements as recited by Yuval with the specific friction reducing element of ceramic portions of the respective elements as recited by Skr) according to known methods to yield predictable results.
Regarding Claim 2, an interpretation of Yuval discloses wherein the outwardly-facing friction reducing elements comprise respective that cover a main body of the drive cable ([0517]-[0519], Figs. 10A, 12-13 see also [0588]; Fig. 12 for example shows an larger diameter wall of ball bearing casing attached to the tube and the inner wall connected with the main body of the drive cable as it goes around the arch).
An interpretation of Yuval may not explicitly disclose the outward facing friction reduction elements are ceramic sleeves.
However, in the same field of endeavor (medical devices), Skr teaches the the outward facing friction reduction elements are ceramic sleeves ([0011] including “Preferably, at the location where the at least one outer layer of the drive shaft is absent or thinned, a bearing sleeve surrounds the at least one inner layer or the thinned at least one outer layer and said bearing sleeve forms an inner surface”, [0015], [0018] including “the bearing sleeve and/or the outer bearing ring comprises one or more ceramic and/or metal”, [0113]-[0114] including “The bearing sleeve 30 is rotatably supported in the outer bearing ring 32 which, in turn, is fixed in the catheter or in a proximal end of the housing”, Figs. 9A-10B) .
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified friction reduction elements as discussed by Yuval to include the friction reduction elements to be ceramic sleeves as recited by Skr because it provides low friction with high durability ([0031]). Alternatively and separately, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to combine modified friction reduction elements as discussed by Yuval to include the opposing friction reduction elements to be ceramic as recited by Skr because it is combining prior art elements (the recitation of using friction reducing elements as recited by Yuval with the specific friction reducing element of ceramic sleeves of the respective elements as recited by Skr) according to known methods to yield predictable results.
Regarding Claim 5, an interpretation of Yuval further discloses wherein the drive-cable-bearing tube further comprises the inwardly-facing friction reducing features at a section of the drive-cable-bearing tube that is configured to sit within an ascending aorta of the subject ([0517] including “friction-reduction elements 170 disposed around at least a portion of the drive cable”, [0518] including “For some applications, the friction-reduction elements are disposed between drive cable 130 and outer tube 142 substantially along the full length of drive cable 130 and outer tube 142. Alternatively, the friction-reduction elements are disposed between drive cable 130 and outer tube 142 at locations at which drive cable 130 and outer tube 142 are configured to be substantially curved, e.g., at the location at which drive cable 130 and outer tube 142 are disposed within the aortic arch,”, [0519], Figs. 10A, 12-13 see also [0588]; Fig. 12 for example shows an larger diameter wall of ball bearing casing attached to the tube and the inner wall connected with the drive cable).
An interpretation of Yuval may not explicitly disclose the inward facing friction reduction elements are ceramic portions.
However, in the same field of endeavor (medical devices), Skr teaches the inward facing friction reduction elements are ceramic portions ([0011] including “Preferably, at the location where the at least one outer layer of the drive shaft is absent or thinned, a bearing sleeve surrounds the at least one inner layer or the thinned at least one outer layer and said bearing sleeve forms an inner surface”, [0015], [0018] including “the bearing sleeve and/or the outer bearing ring comprises one or more ceramic and/or metal”, [0113]-[0114] including “The bearing sleeve 30 is rotatably supported in the outer bearing ring 32 which, in turn, is fixed in the catheter or in a proximal end of the housing”, Figs. 9A-10B).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified friction reduction elements as discussed by Yuval to include the inward facing friciton reduction elements to be ceramic as recited by Skr because it provides low friction with high durability ([0031]). Alternatively and separately, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to combine modified friction reduction elements as discussed by Yuval to include the friction reduction elements to be ceramic as recited by Skr because it is combining prior art elements (the recitation of using friction reducing elements as recited by Yuval with the specific friction reducing element of ceramic portions of the respective elements as recited by Skr) according to known methods to yield predictable results.
Regarding Claim 9, an interpretation of Yuval further discloses wherein the intracorporeal device includes a blood pump (abstract, [0445], [0504] see also [0588]).
Claim Rejections - 35 USC § 103
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yuval in view of Skr in further view of US 20210213274 to Das et al. (hereinafter Das).
Regarding Claim 6, as discussed above in claim Yuval in view Skr discloses the inwardly-facing ceramic. An interpretation of Yuval in view of Skr may not explicitly disclose the ceramic comprise zirconia.
However, in the same field of endeavor (medical devices), Das teaches ceramic sleeves to be made of zirconia ([0033]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the ceramic portions as disclosed by Yuval in view of Skr to be more specifically made of zironica, because it is merely combining prior art elements (ceramic portions as disclosed by Yuval in view of Skr; and the ceramic is more specifically zirconia) according to known methods to yield predictable results.
Regarding Claim 7, as discussed above in claim Yuval in view Skr discloses the outwardly-facing ceramic. An interpretation of Yuval in view of Skr may not explicitly disclose the ceramic comprise zirconia.
However, in the same field of endeavor (medical devices), Das teaches ceramic sleeves to be made of zirconia ([0033]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the ceramic portions as disclosed by Yuval in view of Skr to be more specifically made of zironica, because it is merely combining prior art elements (ceramic portions as disclosed by Yuval in view of Skr; and the ceramic is more specifically zirconia) according to known methods to yield predictable results.
Allowable Subject Matter
Claims 8, 10-11 were not found in the prior art. Claims 8, 10-11 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
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/James Moss/Examiner, Art Unit 3792
