DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Information Disclosure Statement
2. The Information Disclosure Statements submitted on 28 February 2025, 31 July 2025, and 11 June 2026 have been considered by the Examiner.
Claim Rejections - 35 USC § 103
3. 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.
4. Claims 1-4, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Li (US 2021/0220635 A1) in view of Belenger et al. (US Patent No. 4,507,048)
Regarding claim 1, Li teaches a driving mechanism (the pump head 10 comprises a driving mechanism 2020 having a motor 510 that is coupled with the rotating shaft 1030 [0037, 0053]), comprising:
a housing assembly (the pump head housing assembly 10 includes a casing 1 [0037, FIG. 2, FIG. 4, FIG. 6]);
a rotating assembly having a distal end and a proximal end, the distal end of the rotating assembly being rotatably mounted on the housing assembly, the proximal end of the rotating assembly being provided with a first groove (the shaft 103 may be replaced by a rotating shaft 1030 [0053, FIG. 2, FIG. 6]. Specifically, figure 6 illustrates the rotating shaft 1030 having a proximal end portion 104 and a distal end portion that is opposite to the proximal end portion 104 [0045, 0053, FIG. 6]. Furthermore, figure 4 illustrates the proximal end portion 104 being depressed inwardly to form the first bowl-shape groove 308 [0045, 0053, FIG. 4, FIG. 6]), and the first groove having a concave first spherical wall (the first bowl-shaped groove 308 is concave which allows the spherical structure 4 to be disposed between the first bowl-shaped groove 308 and the second bowl-shaped groove 305 [0045, 0053, FIG. 4, FIG. 6]), wherein the housing assembly is provided with a second groove (the pump head housing assembly 10 includes a casing 1 which contains the second bowl-shaped groove 305 [0037, 0045-0046, FIG. 4, FIG. 6]), the second groove being opposed to the first groove, and the second groove having a concave second spherical wall (the second bowl-shaped groove 305 is concave which allows the spherical structure 4 to be disposed between the first bowl-shaped groove 308 and the second bowl-shaped groove 305 [0045, 0053, FIG. 4, FIG. 6]. Specifically, figure 4 illustrates the first bowl-shaped groove 308 being positioned opposite to the second bowl-shaped groove 305 [FIG. 4, 0045-0046]); and
a sphere partially arranged in the first groove and partially arranged in the second groove (the spherical structure 4 may be disposed or embedded between the first bowl-shaped groove 308 and the second bowl-shaped groove 305 [0045, 0053, FIG. 4]).
Although Li teaches the sphere to rotate (the spherical structure 4 may function as a rotating bearing [0046]), Li does not explicitly teach the sphere respectively slidably abutting against the first spherical wall and the second spherical wall.
The prior art by Belenger is analogous to Li, as they both teach centrifugal blood pumps comprising a ball or spherical structure ([abstract]).
Belenger teaches the sphere respectively slidably abutting against the first spherical wall and the second spherical wall (figure 7 illustrates the single ball 25 abutting against the spherical recess of the first jewel 23 and the spherical recess of the second jewel 21 [abstract, column 4 lines 30-50, FIG. 7]. Specifically, the first jewel 23 and the second jewel 21 are configured to withstand continuous frictional contact (e.g., rubbing or sliding contact) with the ball 25 without material heating [column 4 lines 30-50, FIG. 7]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Li’s sphere to slidably abut against the first spherical wall and the second spherical wall, as taught by Belenger. The advantage of such modification may improve the mechanical operation and hemodynamical properties of the blood pump (see the [abstract, column 2 lines 8-16, column 4 lines 30-50] by Belenger).
Regarding claim 2, Li teaches wherein each of an opening edge of the first groove proximate to the second groove and an opening edge of the second groove proximate to the first groove is provided with a rounded portion (Specifically, figure 4 illustrates the open edge of the second bowl-shaped groove 305 being positioned opposite to the open edge of the first bowl-shaped groove 308 [FIG. 4, 0045-0046]. The Examiner respectfully submits that each of the grooves 305 and 308 are “bowl-shaped” which inherently consist of a rounded portion that is defined along the edge [0045-0046, FIG. 4]).
Regarding claim 3, Li in view of Belenger suggests the driving mechanism according to claim 1. Li and Belenger do not explicitly teach wherein a diameter of the sphere is greater than a sum of lengths of the first groove and the second groove along a rotating axis of the rotating assembly.
The Examiner respectfully submits that Li teaches the use of the sphere, the first groove, the second groove, and the rotating assembly ([see the claim 1 above]). Thus, configuring a diameter of the sphere to be greater than a sum of lengths of the first groove and the second groove along a rotating axis of the rotating assembly would be a matter of changing the size of the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 4, Li in view of Belenger suggests the driving mechanism according to claim 3. Li and Belenger do not explicitly teach wherein the length of the first groove along the rotating axis of the rotating assembly is greater than or equal to 1/4 of the diameter of the sphere and less than 1/2 of the diameter of the sphere; and/or,
the length of the second groove along the rotating axis of the rotating assembly is greater than or equal to 1/4 of the diameter of the sphere and less than 1/2 of the diameter of the sphere.
The Examiner respectfully submits that Li teaches the use of the sphere, the first groove, the second groove, and the rotating assembly ([see the claim 1 above]). Thus, configuring the length of the lengths of the first groove and the second groove as recited above would be a matter of changing the size of the known elements without producing a new and unexpected result, with such matters having been held by the Courts as being obvious to the skilled artisan (MPEP 2144.04).
Regarding claim 17, Li teaches wherein the rotating assembly comprises:
a rotating shaft having a proximal end and a distal end (figure 6 illustrates the rotating shaft 1030 having a proximal end portion 104 and a distal end portion that is opposite to the proximal end portion 104 [0045, 0053, FIG. 6]); and
a rotor comprising a first rotor unit (the rotor or impeller assembly 3 [0039, FIG. 6]), wherein the distal end of the rotating shaft is rotatably mounted on the housing assembly (figure 6 illustrates the rotating shaft 1030 having a proximal end portion 104 and a distal end portion that is opposite to the proximal end portion 104 [0045, 0053, FIG. 6]. Specifically, figure 6 illustrates the distal end of the rotating shaft 1030 being coupled directly to casing 1 of the pump head housing assembly 10 [0037, 0053, FIG. 6]), the first rotor unit is fixedly connected to the proximal end of the rotating shaft, and the first groove is formed in the first rotor unit (figure 6 illustrates the shaft 1030 having a proximal end portion 104 [0045, 0053]. Specifically, the proximal end portion 104 forms the first bowl-shaped groove 308 that extends within the impeller assembly 3 [FIG. 4, FIG. 6, 0045]. Furthermore, when the impeller 3 rotates, the blood is delivered through the gap of the first bowl-shaped groove 308 [0045]).
Regarding claim 19, Li teaches a blood pump, comprising an impeller and a driving mechanism(The pump head 10 comprises an impeller 3 [abstract, 0037, 0039-0040, 0053, FIG. 6]. Furthermore, the pump head 10 comprises a driving mechanism 2020 having a motor 510 that is coupled with the rotating shaft 1030 [0037, 0053]), the driving mechanism comprising:
a housing assembly (the pump head housing assembly 10 includes a casing 1 [0037, FIG. 2, FIG. 4, FIG. 6]);
a rotating assembly having a distal end and a proximal end, the distal end of the rotating assembly being rotatably mounted on the housing assembly, the proximal end of the rotating assembly being provided with a first groove (the shaft 103 may be replaced by a rotating shaft 1030 [0053, FIG. 2, FIG. 6]. Specifically, figure 6 illustrates the rotating shaft 1030 having a proximal end portion 104 and a distal end portion that is opposite to the proximal end portion 104 [0045, 0053, FIG. 6]. Furthermore, figure 4 illustrates the proximal end portion 104 being depressed inwardly to form the first bowl-shape groove 308 [0045, 0053, FIG. 4, FIG. 6]), and the first groove having a concave first spherical wall (the first bowl-shaped groove 308 is concave which allows the spherical structure 4 to be disposed between the first bowl-shaped groove 308 and the second bowl-shaped groove 305 [0045, 0053, FIG. 4, FIG. 6]), wherein the housing assembly is provided with a second groove (the pump head housing assembly 10 includes a casing 1 which contains the second bowl-shaped groove 305 [0037, 0045-0046, FIG. 4, FIG. 6]), the second groove being opposed to the first groove, and the second groove having a concave second spherical wall (the second bowl-shaped groove 305 is concave which allows the spherical structure 4 to be disposed between the first bowl-shaped groove 308 and the second bowl-shaped groove 305 [0045, 0053, FIG. 4, FIG. 6]. Specifically, figure 4 illustrates the first bowl-shaped groove 308 being positioned opposite to the second bowl-shaped groove 305 [FIG. 4, 0045-0046]);
a sphere partially arranged in the first groove and partially arranged in the second groove (the spherical structure 4 may be disposed or embedded between the first bowl-shaped groove 308 and the second bowl-shaped groove 305 [0045, 0053, FIG. 4]); and
the impeller is connected to the rotating assembly, and rotatable along with the rotating assembly (the impeller 3 is mounted on the magnetic structure 2 or 6 which is coupled to a rotating shaft (e.g., rotating shaft 1030) of the electric motor 510 [0040, 0053, FIG. 6]. Specifically, the rotating shaft of the electric motor 510 is configured to impart rotation on the magnetic structure 2 or 6 [0040, 0053]. Furthermore, when magnetic structure 2 or 6 rotates, the magnetic structure 2 or 6 drives the impeller 3 to rotate [0040, 0053]).
Although Li teaches the sphere to rotate (the spherical structure 4 may function as a rotating bearing [0046]), Li does not explicitly teach the sphere respectively slidably abutting against the first spherical wall and the second spherical wall.
The prior art by Belenger is analogous to Li, as they both teach centrifugal blood pumps comprising a ball or spherical structure ([abstract]).
Belenger teaches the sphere respectively slidably abutting against the first spherical wall and the second spherical wall (figure 7 illustrates the single ball 25 abutting against the spherical recess of the first jewel 23 and the spherical recess of the second jewel 21 [abstract, column 4 lines 30-50, FIG. 7]. Specifically, the first jewel 23 and the second jewel 21 are configured to withstand continuous frictional contact (e.g., rubbing or sliding contact) with the ball 25 without material heating [column 4 lines 30-50, FIG. 7]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Li’s sphere to slidably abut against the first spherical wall and the second spherical wall, as taught by Belenger. The advantage of such modification may improve the mechanical operation and hemodynamical properties of the blood pump (see the [abstract, column 2 lines 8-16, column 4 lines 30-50] by Belenger).
Allowable Subject Matter
5. Claims 5-16 and 18 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 Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims
Regarding claim 5, Li in view of Belenger suggests the driving mechanism according to claim 1. Li teaches wherein the second groove has a first opening (the second bowl-shaped groove 305 and the first bowl-shaped groove 308 defines an opening or gap that is filled with blood which causes the spherical structure 4 to suspend in the blood [0045]).
However, Li and Belenger do not explicitly teach wherein the second groove has a second opening, the first opening being closer to the first groove than the second opening, and a central axis of the first opening coinciding with a central axis of the second opening;
wherein the second opening is centrally located at the second spherical wall; and/or a diameter of the second opening is 1/9 to 1/3 of the diameter of the sphere.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 6, Li in view of Belenger suggests the driving mechanism according to claim 1. Li teaches wherein the housing assembly comprises a pump case (the pump head housing assembly 10 comprises a casing 1 having an upper pump casing 12 [0037, 0040, FIG. 2, FIG. 4, FIG. 6]) and a support member mounted on the pump case (figures 2 and 6 illustrates the supporting surface 301 being positioned within the upper pump casing 12 [0037, 0040, FIG. 2, FIG. 6]);
wherein the driving mechanism further comprises a support base fixedly connected to the pump case (the casing 1 comprises a lower base 11 [0040, FIG. 2, FIG. 6]. Specifically, the upper pump casing 12 is connected to the lower base 11 [0037, 0040, FIG. 2, FIG. 4, FIG. 6]);
a liquid passing hole formed on the support base (the blood outlet 102 is formed on the lower base 11 [0037-0038, 0047, FIG. 3, FIG. 4, FIG. 6]), and
a mounting cavity in communication with the liquid passing hole (figures 2-3 illustrates the mounting shaft 201 having a hollow body or cavity 203 which is in communication with the blood flow that is delivered through the blood outlet 102 on the lower base 11 [0037, 0044, 0046-0047, FIG. 2, FIG. 3, FIG. 6]), wherein the mounting cavity formed on the support base (figures 2 and 6 illustrates the mounting shaft 201 having the hollow body or cavity 203 which is positioned on the lower base 11 of the casing 1 [FIG. 2, FIG. 6]); an
the second groove is in communication with the liquid passing hole (the blood is delivered through the second bowl-shape groove 305 and is further delivered through the blood outlet 102 on the lower base 11 [0042, 0045-0046, 0048, FIG. 2, FIG. 3, FIG. 4, FIG. 6]).
However, Li and Belenger do not explicitly teach the second groove formed in the support member, and the support member is mounted in the mounting cavity. The Examiner respectfully submits that Li teaches away from claimed structure, as Li’s second groove 305 is formed at the end portions of the vanes 303-304 of the impeller 3, rather than being formed within the support member 301 ([0040-0042, 0045, FIG. 4, FIG. 6]).
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 7-9 are considered to contain allowable subject matter, as claims 7-9 depend upon claim 6.
Regarding clam 10, Li in view of Belenger suggests the driving mechanism according to claim 1. Li teaches wherein the housing assembly comprises a pump case (the pump head housing assembly 10 comprises a casing 1 [0037, 0040, FIG. 2, FIG. 4, FIG. 6]);
a shaft sleeve mounted on the pump case; and a distal end of the rotating assembly extends through the shaft sleeve (the casing 1 includes the rotating shaft 1030 extends through the magnetic structure 2 [0053, FIG. 6]. Specifically, the magnetic structure 2 is sleeve-fit onto the rotating shaft 1030 [0053, FIG. 6]).
Li and Belenger do not explicitly teach wherein the driving mechanism further comprises a stop member fixedly connected to the rotating assembly, wherein the stop member is located between the shaft sleeve and the sphere, and the stop member is capable of abutting against the shaft sleeve to prevent the rotating assembly from moving away from the sphere.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 11-14 are considered to contain allowable subject matter, as claims 11-14 depend upon claim 10.
Regarding claim 15, Li in view of Belenger suggests the driving mechanism according to claim 1. Li teaches wherein the housing assembly comprises a pump case (the pump head housing assembly 10 comprises a casing 1 [0037, 0040, FIG. 2, FIG. 4, FIG. 6]), a support member (figures 2 and 6 illustrates the supporting surface 301 being positioned within the casing 1 [0037, 0040, FIG. 2, FIG. 6]), and a shaft sleeve (the casing 1 includes the rotating shaft 1030 extends through the magnetic structure 2 [0053, FIG. 6]. Specifically, the magnetic structure 2 is sleeve-fit onto the rotating shaft 1030 [0053, FIG. 6]), wherein the support member and the shaft sleeve are mounted on the pump case (the supporting surface 301 and the sleeve-fit magnetic structure 2 are disposed within casing 1 [FIG. 6]);
a distal end of the rotating assembly rotatably extends through the shaft sleeve sleeve (the casing 1 includes the rotating shaft 1030 extends through the magnetic structure 2 [0053, FIG. 6]. Specifically, the magnetic structure 2 is sleeve-fit onto the rotating shaft 1030 [0053, FIG. 6]);
the sphere is movably received in the pump case (the spherical structure 4 may function as a rotating bearing within the casing 1 [0046, FIG. 4]); and
the support member, the shaft sleeve, and the sphere are arranged along a rotating axis of the rotating assembly (figures 4 and 6 illustrates the end portion of 104 of the rotating shaft 1030 has an axis that is aligned with the supporting surface 301, the magnetic sleeve structure 2, and the spherical structure 4 [FIG. 4, FIG. 6]).
Li and Belenger do not explicitly teach wherein the second groove is formed in the support member, and the support member, the shaft sleeve, and the sphere are capable of collectively limit the rotating assembly. The Examiner respectfully submits that Li teaches away from claimed structure, as Li’s second groove 305 is formed at the end portions of the vanes 303-304 of the impeller 3, rather than being formed within the support member 301 ([0040-0042, 0045, FIG. 4, FIG. 6]).
Regarding claim 18, Li in view of Belenger suggests the driving mechanism according to claim 17. Li and Belenger do not explicitly teach wherein the rotor further comprises a second rotor unit fixedly connected to the rotating shaft and arranged proximate to the distal end of the rotating shaft;
wherein the driving mechanism further comprises a stator, the stator comprising a first stator unit and a second stator unit which are arranged along an axis of the rotating shaft, wherein the first stator unit and the second stator unit are located between the first rotor unit and the second rotor unit; the first stator unit is capable of driving the first rotor unit to rotate, and the second stator unit is capable of driving the second rotor unit to rotate; each of the first stator unit and the second stator unit comprises a magnetic core and a coil wound around the magnetic core;
the driving mechanism further comprises a magnetic conductive member connected to the housing assembly; the magnetic core of the first stator unit and the magnetic core of the second stator unit are fixedly connected to the magnetic conductive member; and
the rotating shaft rotatably extends through the first stator unit, the second stator unit, and the magnetic conductive member.
The prior art by Granegger (US 2021/0268262 A1) is analogous to Li, as they both teach a blood pump comprising a sphere or ball bearing ([abstract, 0148]).
Granegger teaches wherein the rotor further comprises a second rotor unit fixedly connected to the rotating shaft and arranged proximate to the distal end of the rotating shaft (figure 3 illustrates the second rotor 76 being positioned at the distal end of the shaft 10 [0150, FIG. 3]. Meanwhile, figure 3 illustrates the first rotor 75 being positioned at the proximal end of the shaft 10 [0150, FIG. 3]. Specifically, the shaft 10 is configured to rotate [0146]);
wherein the driving mechanism further comprises a stator, the stator comprising a first stator unit and a second stator unit which are arranged along an axis of the rotating shaft (figure 3 illustrates the second stator 78 being positioned at the distal end of the shaft 10 [0150, FIG. 3]. Meanwhile, figure 3 illustrates the first stator 77 being positioned at the proximal end of the shaft 10 [0150, FIG. 3]. Specifically, the shaft 10 is configured to rotate [0146]), wherein the first stator unit and the second stator unit are located between the first rotor unit and the second rotor unit (figure 3 illustrates the first stator 77 and the second stator 78 being located between the first rotor 75 and the second rotor 76 [0150, FIG. 3]);
the first stator unit is capable of driving the first rotor unit to rotate, and the second stator unit is capable of driving the second rotor unit to rotate (the motors 71 and 72 are coupled to the first stator 77 and the second stator 78, respectively [0138-0140, 0150]. Specifically, the motors 71-72 drive the stators 77-78 to rotate the rotors 75-76 [0138-0140, 0150]);
each of the first stator unit and the second stator unit comprises a coil (each stator 77 and 78 comprises bearing coils 63 [0150]).
Granegger does not explicitly teach wherein the coil of each of the first stator unit and the second stator unit is wound around a magnetic core;
the driving mechanism further comprises a magnetic conductive member connected to the housing assembly;
the magnetic core of the first stator unit and the magnetic core of the second stator unit are fixedly connected to the magnetic conductive member; and
the rotating shaft rotatably extends through the first stator unit, the second stator unit, and the magnetic conductive member.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitations. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Conclusion
6. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The prior art by Ohara (U.S. Patent No. 5,601,418) is pertinent to Applicant’s disclosure, as Ohara teaches a blood pump comprising a sphere (e.g., ball) and impellers ([abstract]).
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
Prosecution Insights