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 .
The amendment filed on August 20, 2025 has been received and considered. By this amendment, claims 1-3, 5, and 8-10 are amended and claims 1-11 are now pending in the application.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 4-6, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Araki (WO 02/27225, previously cited) in view of Groß-Hardt et al. (U.S. 2017/0087288). Regarding claim 1, Araki discloses a centrifugal blood pump for effectuating conveying of blood in between an axial inlet cannula 1 and a tangential outlet cannula 2 (Figure 1 and “The casing 3 comprises an inlet 1 at its upper end and an outlet 2 at the bottom thereof”, page 13, lines 24-25), said centrifugal blood pump comprising; a housing shroud 3 comprising a pumping chamber housing an impeller 4 comprising embedded passive magnets 15 and a rotating hub 12 centered on an axis of rotation, and a magnetic drive means 16 magnetically coupled to said impeller for actuating the rotation of impeller, and said impeller comprising a plurality of main blades 5 attached onto said rotating hub 12 (see Figure 2). However, Araki fails to disclose said main blades have a blade wrap angle in the range of 100°-125°, a blade angle at the hub in the range of 30°-40°, a blade angle at the shroud in the range of 55°-62.5°, and a blade lean angle (A) (25) in the range of 0°-25°. Groß-Hardt teaches a non-occluding intravascular pump comprising a shroud, impeller, and rotating hub (see Abstract), wherein the dimensions of the components of the system are chosen in order to reduce hemolysis (“The pump may further provide a variety of design features to reduce hemolysis”, paragraph [0005]), including a blade wrap angle in the range of 100°-125° (“In some embodiments, the wrap angle may be 100+/−10 degrees.”, paragraph [0042]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Araki to have a blade wrap angle in the range of 100°-125°, as taught by Groß-Hardt, in order to reduce hemolysis. Furthermore, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the blade angles of Araki to have a blade angle at the hub to be in the range of 30°-40°, a blade angle at the shroud to be in the range of 55°-62.5°, and a blade lean angle (A) to be in the range of 0°-25°, as it involves only adjusting the dimensions of the blades, which Groß-Hardt has shown to be routine experimentation. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the blade angles of Araki to have a blade angle at the hub to be in the range of 30°-40°, a blade angle at the shroud to be in the range of 55°-62.5°, and a blade lean angle (A) to be in the range of 0°-25° as a matter of routine optimization since it has been held that “where 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 optimization.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 2, Araki in view of Groß-Hardt provides the invention substantially as claimed, but fails to provide that the blade wrap angle is in the range of 120°-125°. It appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the blade wrap angle of Araki to be in the range of 120°-125°, as it involves only adjusting the dimensions of the blades, which Groß-Hardt has shown to be routine experimentation. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the blade angles of Araki to have a blade wrap angle in the range of 120°-125° as a matter of routine optimization since it has been held that “where 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 optimization.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 4, Araki discloses that said impeller comprises a plurality of splitter blades (it can be seen in Figure 7 that there are 4 blades, where two can be considered the claimed plurality of main blades and two can be considered to claimed splitter blades, as neither one is defined in any specific sense).
Regarding claim 5, it is respectfully submitted that in the embodiment of Figure 7 of Araki, where the main blades are considered two blades located opposite one another and the splitter blades are considered the other two blades shown, said splitter blades would have an angular offset of 50% corresponding to the main blades.
Regarding claim 6, Araki discloses that said impeller comprises five main blades (“Usually there are provided 2-8 vanes”, page 10, line 19).
Regarding claim 8, Araki discloses the invention substantially as claimed, but fails to disclose that each blade is rounded with the elliptic ratio of 2.0 at the leading edge and trailing edge. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Araki such that each blade is rounded with an elliptic ratio of 2.0 at the leading edge and trailing edge, since it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). Furthermore, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 9, Araki discloses that said magnetic drive means comprises a motor (“Driving magnet 16 is rotated by a motor placed out of the pump”, page 13, line 27-page 14, line 1), a magnetic rotor disk having embedded permanent magnets 16 attached to motor housed in a motor cover housing attached to said housing shroud (see Figures 1, 3, and 4), and permanent magnets of magnetic rotor disk are coupled to embedded passive magnets 15 with opposite polarity embedded in the impeller for actuating the rotation of impeller (see Figures 1, 3, and 4 and “driven magnets 15 in the magnet casing 14 at the lower portion are magnetically coupled with the driving magnet 16 located out of the casing 3. Driving magnet 16 is rotated by a motor placed out of the pump. As a result, the impellers and associated driven magnets 15 are rotated so as to supply energy to the blood”, page 13, line 26-page 14, line 2). However, Araki fails to disclose that the motor is embedded. It would have been obvious to one having ordinary skill in the art before the effective filing date to embed the motor of Araki in the housing with the impeller since it was known in the art that placing a motor in the same housing as an impeller and magnetic driving means provides a device that may be completely implanted within the body without required external connections.
Regarding claim 10, Araki discloses that said impeller is disposed between axial sliding bearings along an axis of rotation (“According to a fifth aspect of the present invention, there is provided a turbo blood pump according to the above mentioned three aspects wherein an upper portion and lower portion of the impeller rotary shaft are structured in a pivot bearing structure and sliding bearing structure, the sliding bearing of the cylindrical face contacting type.”, page 5, lines 21-24).
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Araki (WO 02/27225, previously cited) in view of Groß-Hardt et al. (U.S. 2017/0087288) as applied to claims 1, 2, 4-6, and 8-10 above, and further in view of Stewart et al. (U.S. 2020/0407940, previously cited). Araki in view of Groß-Hardt discloses the invention substantially as claimed, but fails to disclose that said impeller comprises five splitter blades or said inlet cannula houses a flow straightener having straight inducer blades. Stewart teaches a centrifugal pump 5 that includes an impeller comprising primary blades 46 and splitter blades 47 (“The stator blades 45 comprises a plurality of primary stator blades 46 and secondary or splitter blades 47 provided between adjacent pairs of primary stator blades 46.”, paragraph [0123]) and a flow straightener having straight inducer blades 50 (nozzle 30 including anti-rotation vanes 50, see Figure 3). Stewart teaches that a splitter blade “is a small blade between each main blade” and the “splitter blades increase the blading and hence help to straighten the flow but do not increase the blockage to an unacceptable level because they are only present in the area where the blade angles are smaller” (see paragraph [0153]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of in view of Groß-Hardt to include a flow straightener having straight inducer blades in the inlet cannula and five splitter blades (one splitter blade between each main blade), as taught by Stewart, in order to straighten the flow without increasing the blockage to an unacceptable level and as it has been held that known work in one field of endeavor may prompt variations of it for use in either the same field or a different based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007).
Allowable Subject Matter
Claim 3 is 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.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAMMIE K MARLEN whose telephone number is (571)272-1986. The examiner can normally be reached Monday through Friday from 8 am until 4 pm.
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/TAMMIE K MARLEN/Primary Examiner, Art Unit 3796