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
The information disclosure statements (IDS) submitted on April 18, 2024, July 15, 2024, and November 7, 2024 contain more than 550 references. The information disclosure statements have been considered by the examiner inasmuch as is practically possible. However, if Applicant believes any specific reference to be pertinent to patentability, such references should be particularly brought to the examiner’s attention.
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 5 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.
Claim 5, lines 1-2 recites the phrase “wherein the thrust bearing comprises the proximally-facing ceramic surface by virtue of being coated with a ceramic coating.” This phrase is unclear, as it is not known if the bearing is required to be coated with a ceramic coating.
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.
Claims 1, 4-5, 8, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Jarvik (US 5,507,629).
Regarding claim 1, Jarvik discloses the claimed a blood pump, comprising (e.g. Figures 1-4):
an axial shaft configured for insertion into, and rotation within, a body of a subject (e.g. rotor 34);
an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject (e.g. impeller 36 and 38);
a thrust bearing comprising a proximally-facing ceramic surface and disposed distally from the axial shaft so as to inhibit distal movement of the axial shaft beyond the thrust bearing ("thrust bearing": see column 4, lines 48-52; see figure 4); and
a distally-facing cover (e.g. wear-resistant insert 66) that covers a distal end of the axial shaft such that the cover contacts the surface as the axial shaft rotates (e.g. contact surface of wear-resistant insert 64 as axial shaft 34 rotates).
Jarvik does not expressly disclose that the distally facing cover is ceramic. Jarvik does disclose that it was well known in the art use wear resistant inserts that are ceramic (e.g. distally located wear-resistant inserts 40 and 42 that can be made from a ceramic material (see column 4, lines 37-40). It would therefore be obvious for the person skilled in the art, when choosing a material for the wear-resistant inserts of the distal thrust bearing to use the same material as used for the proximal wear resistant insert, since such a modification would provide the system with the reliable results of a wear resistant insert.
Regarding claim 4, Jarvik additionally discloses wherein the thrust bearing comprises a piece of ceramic comprising the proximally-facing ceramic surface (e.g. as shown in Figure 4).
Regarding claim 5, Jarvik wherein the thrust bearing comprises the proximally-facing ceramic surface by virtue of being coated with a ceramic coating (e.g. as shown in Figure 4).
Regarding claim 8, Jarvik additionally discloses a distal bearing housing that houses the distal thrust bearing (e.g. bearing support strut 46: see figures 2 and 4) and a distal radial bearing that is housed within the distal bearing housing and is configured to radially stabilize the axial shaft while the axial shaft rotates (the inner surface of "lip" 68 of wear resistant insert 64 can be considered as a radial bearing: see paragraph column 4, lines 64-67)
Regarding claim 12, Jarvik additionally discloses a ceramic cap that comprises the ceramic cover and fits around the distal end of the axial shaft (e.g. wear-resistant insert 66).
Claims 1-5, 8-9, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Salahieh (US 2019/0344001) in view of Jarvik.
Regarding claim 1, Salahieh discloses the claimed a blood pump, comprising (e.g. Figures 18B, 18D, and 19):
an axial shaft configured for insertion into, and rotation within, a body of a subject (e.g. shaf 346 and attached portions)
an impeller coupled to the axial shaft such that, as the axial shaft rotates, the impeller pumps blood of the subject (e.g. proximal impeller 341 and "distal impeller" 342)
a thrust bearing comprising:
a proximally-facing ceramic surface and disposed distally from the axial shaft so as to inhibit distal movement of the axial shaft beyond the thrust bearing (e.g. thrust bearing 366: see paragraph 150 and figure 18D) and
a distally-facing cover (e.g. see figure 18D) that covers a distal end of the axial shaft such that the cover contacts the surface as the axial shaft rotates.
Salahieh does not expressly disclose that the distally facing cover is ceramic. Jarvik does disclose that it was well known in the art use wear resistant inserts that are ceramic (e.g. distally located wear-resistant inserts 40 and 42 that can be made from a ceramic material (see column 4, lines 37-40). It would therefore be obvious for the person skilled in the art, to use the ceramic cover of Jarvik in the device of Salahieh, since such a modification would provide the system with the reliable results of a wear resistant insert.
Regarding claim 2, Salahieh additionally discloses a drive cable, wherein the axial shaft is coupled to the drive cable such that the axial shaft rotates with the drive cable (e.g. drive cable as disclosed in [0148] – [0149]).
Regarding claim 3, Salahieh additionally discloses a drive cable, wherein the axial shaft is a distal portion of the drive cable (e.g. the fourth section 365 of the drive cable in figure 18D).
Regarding claim 4, Salahieh additionally discloses wherein the thrust bearing comprises a piece of ceramic comprising the proximally-facing ceramic surface (e.g. as shown in Figure 18D).
Regarding claim 5, Salahieh additionally discloses wherein the thrust bearing comprises the proximally-facing ceramic surface by virtue of being coated with a ceramic coating (e.g. as shown in Figure 18D).
Regarding claim 8, Salahieh additionally discloses wherein the blood pump further comprises a distal bearing housing that houses the distal thrust bearing (e.g. bearing housing shaft section 347 that houses the thrust bearing 366; Figure 18D); and a distal radial bearing that is housed within the distal bearing housing and is configured to radially stabilize the axial shaft while the axial shaft rotates (e.g. bearing 351).
Regarding claim 9, Salahieh additionally discloses wherein the axial shaft is configured for insertion, over a guidewire, and is shaped to define a shaft lumen for passage of the guidewire therethrough, and the thrust bearing is shaped to define a bearing lumen that is configured to be continuous with the shaft lumen (e.g. shaft lumen as disclosed in [0149 and as shown in Figure 18D).
Regarding claim 12, Jarvik additionally discloses a ceramic cap that comprises the ceramic cover and fits around the distal end of the axial shaft (e.g. wear-resistant insert 66).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Jarvik or Salahieh in view of Jarvik.
Regarding claims 6-7, Jarvik or Salahieh in view of Jarvik disclose the claimed invention except the express mention of ceramic surface that comprises zirconia. Asada disclose that it was well known in the art of thrust bearings to include a surface of zirconia (e.g. Col. 6, lines 1-25). It would have been obvious to one having ordinary skill in the art to include the zirconia coated thrust bearing of Asada in the device of Jarvik or Salahieh in view of Jarvik in order to provide the system with the predictable results of a reliable thrust bearing.
Allowable Subject Matter
Claims 10-11 and 13 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 Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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