7Notice 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 current application has the effective filing date of 08/18/2022.
Claim Status
As per preliminary claim amendment received on 10/07/2024, claims 1-20 are pending; and all pending claims have been amended.
Claim Objection
Claims 2, 8, 10 and 16 are objected to because of the following informalities:
To claim 2, line 2-3 the limitation “each of the at least two vanes is a bent and twisted vane or a straight vane…” is objected to because the placement of terms “and” and “or” results in two different interpretations of the same claim term.
To claims 8 and 16, the phrase “1.2D<H<1.6D,0.3Didl0.4D, 0.4Dsh<0.7D” is objected to for missing “and.”
To claim 10, the last clause “comprises blood outlets located in an artery at a working position” should be rephrased such that the outlets are configured to be placed in an artery.
Appropriate correction is required.
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.
Claims 3-4, 9 and 10 are 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.
The term “close to” in claims 3 and 4 is a relative term which renders the claim indefinite. The term “close to” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Further regarding claim 3, the term “basically consistent” is another relative term which renders the claim indefinite. The term “basically consistent” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention
Regarding claims 9 and 10, which individually depends from claim 1, the terms “the outlet base” and “the outlet housing” lack proper antecedent basis because these terms are first introduced in claim 2.
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.
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, 6-7, 8, 12 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. CN215309683U (hereinafter “Liu”, original document submitted by the Applicant, Google English translation is applied in the following rejection, English translation attached).
Regarding claim 1, Liu discloses an interventional blood pump (intravascular heart assist device as shown in Figs. 1-9 and pg.4: example 1), comprising a pump body (implicit feature, as shown in Figs. 1-2; also see claim 1 “body part”) and a driving unit (motor 10), the pump body comprising an impeller (impeller 20), a blood flow catheter (sleeve 40), a blood flow inlet structure (inflow chamber 50), and a blood flow outlet structure (outflow chamber 30) which are in driving connection to the driving unit (10), wherein the blood flow outlet structure (30) comprises an outlet housing (outflow chamber bracket/holder 31), an outlet base (pump stator 23) and a guide vane structure (blades and vanes 22 and 24) arranged on the outlet base (23) and connected to the outlet housing (31; see Figs. 4-5 and pg. 4, para. 11 “…at least one guide vane 24 is arranged on the periphery of the pump stator 23, and the guide vane 24 is attached to the inner side of the outflow chamber bracket 31…”); at least a part of the impeller (impeller shaft 21 and blade 22 of impeller 20) is accommodated in the outlet housing (see Figs. 4-5 and pg. 4, para. 11 “…one end of the pump stator 23 is connected with the motor box, the other end of the pump stator 23 is arranged close to the impeller shaft 21…”); and the guide vane structure (24) is configured to be capable of converting a rotational motion of a blood flowing out of the impeller into a primarily axial motion (pg. 4 and para. 11 “The fluid design of the outflow chamber 30 and the pump stator 23 is not affected by the ease of assembly, and the rotational energy of the blood flow pumped out of the outflow chamber 30 is further converted into axial kinetic energy…”).
Regarding claim 2, Liu discloses the interventional blood pump according to claim 1, wherein the guide vane structure (22, 24) comprises at least two vanes (Figs. 4-5 illustrate 3 pieces of vanes; alternatively, see pg. 4, para. 6: 2-3 pieces); each of the at least two vanes (22, 24) is a bent and twisted vane (Figs. 4-5 are curved/spiral, interpreted as “bent and twisted vane” in the claim) or a straight vane; the each of the at least two vanes comprises a vane tip and a vane root which are respectively connected to the outlet housing and the outlet base. as well as an inlet edge and an outlet edge which are connected to the vane tip and the vane root; and the inlet edge is located on an upstream side of the outlet edge in an axial direction. (These features are taught by illustration, as shown in Figs. 4-5, and also see pg.4, para. 5-12 regarding the discussion of ‘blades’ and ‘vanes’)
Regarding claim 6, Liu discloses the interventional blood pump according to claim 1, wherein a proximal end of the blood flow inlet structure (50) is fixed at a distal end of the blood flow catheter (40, as shown in Figs. 1-2) or a distal end of the outlet housing (31); a distal end of the blood flow inlet structure (50) comprises an inlet base (implicit, where 50 is attached to 60 as shown in Figs. 1-2) fixed with a pigtail catheter (extension tube/pipe 60); the blood flow inlet structure (50) comprises a bell-shaped flow guide cone (see Fig. 3: cone tip) arranged on the inlet base and a blood suction inlet (blood inlet 51) extending from the inlet base to the proximal end of the blood flow inlet structure (see Fig. 3); a diameter of a distal end of the flow guide cone is greater than a diameter of a proximal end of the flow guide cone (inherent feature of a cone, and as illustrated in Fig. 3: cone tip); and the flow guide cone comprises a conical or concave flow guide surface connecting the distal end and the proximal end of the flow guide cone (as illustrated in Fig. 3, also see pg. 4, para. 13-15, “The device provided by the utility model also comprises… blood enters the sleeve 40 from the blood inlet 51”).
Regarding claim 7, Liu disclose the interventional blood pump according to claim 6, wherein a rotational generatrix of the flow guide surface is a straight line, a concave circular curve or a concave elliptical curve. (These features are inherent, see rejection to claim 6 above.)
Regarding claim 9, Liu disclose the interventional blood pump according to claim 1, wherein the impeller (20) is directly connected to an output shaft of the driving unit (10); the pump body sequentially comprises the blood flow outlet structure (30), the impeller (20), the blood flow catheter (40), and the blood flow inlet structure (50) from a proximal end to a distal end (as shown in Figs. 1-2); the outlet base (23) is fixed on a shell (e.g. motor box of motor 10) of the driving unit (10; pg. 4, para. 11 “The body portion further includes: one end of the pump stator 23 is connected with the motor box…”); and a proximal end of the blood flow catheter (40) is fixed on the outlet housing (31; as shown in Figs. 10-11).
Claim 12 and 17, each dependent from claim 2, these claims are rejected by Liu under the same rationale as discussed to claims 6 and 9 above, respectively.
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.
Claims 3-4, 13-14, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied to claim 1 above, and further in view of Cheng et al. CN114306921A (hereinafter “Cheng”, original document submitted by the Applicant, Google English translation is applied in the following rejection, English translation attached).
Regarding claim 3, Liu discloses the interventional blood pump according to claim 2, wherein the each vane (22, 24) is the bent and twisted vane (see Figs.4-5). Liu does not mention the specifics dimensions and/or angles of the vanes. It would have been obvious to a person of ordinary skill in the art at the time of invention to try various shapes, sizes, and setting angles for the vanes in view of Liu in order to optimize performance and/or blood flow dynamics. Alternatively Cheng, another prior art reference in analogous art teaches a cardiac blood pump (Figs. 1 and 3) comprising an blood flow outlet structure (3) comprising at least two guide vane structures (guide vanes 304), wherein each vane is the bent and twisted vane (as shown in Fig. 5); and a vane root setting angle and a vane tip setting angle gradually increase along a blood flow direction respectively the vane root setting angle and the vane tip setting angle are basically consistent with a flow angle of blood flowing out of the impeller from a corresponding position at an inlet of the guide vane structure respectively; and the vane root setting angle is close to 90° at an outlet of the guide vane structure to reduce the circulation of blood at the outlet (Figs. 4-5, also see Cheng: pg. 6: Embodiment/Example 2 which encompasses Embodiment/example 1). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Liu’s guiding vanes in view of Cheng, the motivation for doing so is to increase axial linear speed and thus increase blood flow (see Cheng: Example 2.)
Regarding claim 4, Liu in view of Cheng teaches interventional blood pump according to claim 3, wherein the vane tip setting angle is close to 90° at the outlet of the guide vane structure (see Cheng Fig.5 the tip of each vane 304 appears to be “close to 90°).
Regarding claims 13 and 18, each dependent from claim 3, these claims are rejected by Liu under the same rationale as discussed to claims 6 and 9 above, respectively.
Regarding claims 14 and 19, each dependent from claim 4, these claims are rejected by Liu under the same rationale as discussed to claims 6 and 9 above, respectively.
Claims 5, 8, 15, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied to claim 1 above.
Regarding claim 5, Liu discloses the interventional blood pump according to claim 2 comprising at least 2-3 vanes/blades 22 and 24, Liu, in pg. 3 Summary discloses the diameter of the impeller, and outer diameter, but Liu does not disclose wherein a thickness of the each of the at least two vanes (22, 24) ranges from 0.2 mm to 0.4 mm. However, the thickness of each of the vanes would have been an obvious design choice at the time of invention based on the needs to adjust the dimensions for efficiency of blood flow (Liu: pg. 5, para. 5 “By adjusting the shape and size of the impeller shaft 21 and the rotating curved surface of the blades 22, the flow of blood along the impeller shaft 21 and the shear stress of the blades 22 are improved, and the compatibility of blood pumping efficiency and blood compatibility is realized.”), and such that “the requirement of clinical intervention through blood vessels with different inner diameters is met.” (Liu: pg. 4, para. 11 last sentence)
Regarding claim 8, Liu disclose the interventional blood pump according to claim 6, Liu discusses the shape of the blood suction inlet in pg. 3, para. 1, but does not explicitly disclose wherein a diameter of an outer contour of the blood suction inlet (51) is D and an axial length is H, the diameter of the proximal end of the flow guide cone (22) is d1 and an axial length is h, and these parameters meet: 1.2D<H<1.6D, 0.3D<d1<0.4D, 0.4D<h<0.7D. However, these dimensions would have been an obvious design choice at the time of invention based on the needs to adjust the dimensions such that “the requirement of clinical intervention through blood vessels with different inner diameters is met.” (Liu: pg. 4, para. 11 last sentence)
Claims 15 and 20, each dependent from claim 5, these claims are rejected by Liu under the same rationale as discussed to claims 6 and 9 above, respectively.
Claim 16, dependent from claim 7, is rejected by Liu under the same rationale as discussed to claim 8 above.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Liu as applied to claim 1 above, and in view of Siess et al. US 11,020,584 B2.
Regarding claim 10, Liu discloses the interventional blood pump according to claim 1, Liu does not teach wherein the impeller is connected to an output shaft of the driving unit through a flexible shaft
However Siess, a prior art reference in analogous art teaches an interventional blood pump (Fig. 1: blood pump 1), wherein an impeller (impeller/rotor) is connected to an output shaft of the driving unit (motor 2) through a flexible shaft (sleeve 4 comprises flexible membrane/material, see col.9, ll.19-24 and claims 9 and 10), the pump body sequentially comprises the blood flow catheter (flow cannula 3), the blood flow outlet structure (blood flow outlet 12), the impeller (impeller/rotor), and the blood flow inlet structure (EP) from a proximal end to a distal end (see Fig.1); the blood flow catheter (3) is a radially expandable catheter (col.7, ll.20-33) having a distal end connected to an outlet housing (3 is attached to outlet 12); the blood flow catheter (3) is arranged outside the flexible shaft (4) and extends on at least a part of a length of the flexible shaft (see Fig. 5A-5B); when a blood flowing out of the blood flow outlet structure enters the radially expandable catheter, so that the radially expandable catheter is in a radial expansion state, a gap between the radially expandable catheter and the flexible shaft forms a blood flow channel (flow through openings 16); and a proximal part of the radially expandable catheter comprises blood outlets located in an artery at a working position (“working position” is interpreted as when the heart pump is implanted to provide treatment). (see col.6, ll.45-60, col.7, ll.5-58). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Liu to include the radially expandable catheter in view of Siess, the motivation for doing so is to provide the benefit that in the compressed configuration the heart pump can be easily inserted into a working position in the heart, and that in the expanded configuration can provide improved blood flow condition at the blood inflow inlet. (Siess: col.2, ll.21-63)
Regarding claim 11, Liu discloses the interventional blood pump according to claim 10, wherein when the blood pump is located at the working position, both the driving unit and the pump body are located inside a body (inherent, see Liu: pg. 2: Background and Siess: Fig. 1), and the proximal end of the radially expandable catheter is hermetically connected to a housing of the driving unit (see modification to claim 10 above, and Siess: see Fig. 5A-5B and col.5, ll.65-col.6, ll.28).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Farnan et al. US 8545380 discloses an intravascular heart pump comprising guiding vanes; see Figs. 8-10.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
July 28, 2026
Prosecution Insights