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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/07/2026, with respect to the rejection(s) of claim(s) under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the following. See detailed rejection below.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 5-10, 21, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calomeni et al (US20210008261A1; hereinafter “Calomeni”) in view of Zeng et al. (US20130303830A1; hereinafter “Zeng”).
Regarding claims 1 and 21, Calomeni teaches an apparatus comprising: a blood pump ([0010] catheter blood pump) comprising an impeller ([0010] expandable impeller), the impeller being configured: to be delivered through vasculature of a subject ([0051] deploying a pump portion of a catheter blood pump) while the impeller is in a radially-constrained configuration, to self-expand to a non-radially-constrained configuration ([0086] adapted to be collapsed to a delivery configuration so that it can be delivered with a lower delivery profile. The impellers may be attached to drive mechanism 1612), and to pump blood while in the non-radially-constrained configuration, wherein (a) a diameter of the impeller when the impeller is in its non-radially-constrained configuration at a location at which the diameter of the impeller is at its maximum ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm) and (b) a diameter of the impeller when the impeller is in its radially-constrained configuration ([0108] This allows it to be delivered using a lower profile delivery device (smaller French size) than would be required if none of working portion 1104 was collapsible, [0159] pigtail catheter can be used to deliver so the size ranges from 6 French to 18 French - 2mm to 6 mm).
Calomeni fails to explicitly disclose the dimensions of the collapsed diameter and therefore fails to disclose the ratio to be greater than 7:2 (as in claim 21, less than 2mm and more than 7 mm).
Zeng, from a similar field of endeavor teaches an impeller assembly having a stored configuration and a diameter that is preferably small enough to be inserted percutaneously into a patient's vascular system [] the impeller 300 can have a diameter in the stored configuration corresponding to a catheter size []about 8 FR [] (para 0045, 8 Fr = 2.7 mm) and when the impeller is positioned within a chamber of the heart it can be advantageous to expand the impeller to have a diameter as large as possible in the expanded or deployed configuration [] the impeller can have a diameter corresponding to a catheter size greater than about 21 FR in the deployed or expanded configuration (para 0046; 21Fr = 7 mm) in order to increase the flow rate of the heart pump while reducing the motor speed (para 0047, 0049). Zeng further teaches that it can be advantageous to make the diameter of the impeller and the cannula as small as possible for insertion into the patient's vasculature (para 0049). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Calomeni with the teachings of Zeng, because doing so would allow for taking advantage of a low profile to provide the predictable result of improving the safely insertion of the pump while increasing the flow rate of the heart pump while reducing the motor speed (para 0050).
It is noted that Calomeni as modified by Zeng do not explicitly disclose the claimed ratio. However, the Calomeni discloses the various expanded diameter while Zeng teaches the stowed dimensions. Zeng further teaches that smaller diameters for the stowed impeller and larger diameters for the deployed impeller are desirable as they would improve insertion and operation. Therefore, the claimed ratio is considered to be disclosed, taught and/or rendered obvious by the combination presented above.
The court has further 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, the specification as originally presented has not provided any evidence that the particular range is critical.
PNG
media_image1.png
589
893
media_image1.png
Greyscale
Regarding claim 2, Calomeni as modified by Zeng renders obvious the apparatus according to claim 1, wherein, in its radially-constrained configuration, the impeller has a diameter of less than 2 mm ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm”; it is understood that “1mm” could be considered the stored diameter; Zeng, para 0049 “advantageous to make the diameter of the impeller and the cannula as small as possible for insertion into the patient's vasculature”).
Regarding claim 5, Calomeni as modified by Zeng renders obvious the apparatus according to claim 1, wherein the impeller comprises an impeller frame that comprises proximal and distal end bushings ([0112] proximal strut, coupled to bearing 361, bearing 350 is also coupled to the distal region of central tubular member 346), at least one helical elongate element that winds from the proximal bushing to the distal bushing (fig. 1 shows a helical shape), and an elastomeric material that is coupled to the at least one helical elongate element, such that the at least one helical elongate element with the elastomeric material coupled thereto defines a blade of the impeller ([0087] polyurethane elastomers).
Regarding claim 6, Calomeni as modified by Zeng renders obvious the apparatus according to claim 5, wherein the impeller further comprises a spring that extends from the first bushing to the second bushing ([0092] any of the impellers herein can include one or more blades made from a plastic formulation with spring characteristics), and wherein the elastomeric material is coupled to the at least one helical elongate element such as to form a film of the elastomeric material that extends from the at least one helical elongate element to the spring ([0087] polyurethane elastomers).
Regarding claim 7, Calomeni as modified by Zeng renders obvious the apparatus according to claim 5, wherein the at least one helical elongate element comprises two elongate elements, and wherein the elastomeric material is coupled to the two helical elongate elements, such that the two helical elongate elements with the elastomeric material coupled thereto define a blade of the impeller (figure 1 shows 2 helical components intertwining).
Regarding claim 8, Calomeni as modified by Zeng renders obvious the apparatus according to claim 5, wherein the at least one helical elongate element comprises three or more elongate elements ([0244] The impellers have one or more blades), and wherein the elastomeric material is coupled to the three or more helical elongate elements, such that each of the three or more helical elongate elements with the elastomeric material coupled thereto defines a respective blade of the impeller ([0092] any of the impellers herein can include one or more blades made from a plastic formulation with spring characteristics, [0087] polyurethane elastomers).
Regarding claim 9, Calomeni as modified by Zeng renders obvious the apparatus according to claim 1, wherein, in its non-radially-constrained configuration, the diameter of the impeller at the location at which the diameter of the impeller is at its maximum is more than 7 mm ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm; Zeng, para 0046-0049).
Regarding claim 10, Calomeni as modified by Zeng renders obvious the apparatus according to claim 9, wherein, in its non-radially-constrained configuration, the diameter of the impeller at the location at which the diameter of the impeller is at its maximum is more than 8 mm ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm; Zeng para 0046-0049).
Regarding claim 24, Calomeni as modified by Zeng renders obvious the apparatus according to claim 21, wherein, in its non-radially-constrained configuration, the diameter of the impeller at the location at which the diameter of the impeller is at its maximum is more than 8 mm ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm; Zeng, para 0046-0049).
Claim(s) 3, 4, 11-20, 22, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Calomeni in view of Zeng and Alexander et al (US 20200405926 A1; hereinafter “Alexander”).
Regarding claim 3, Calomeni as modified by Zeng renders obvious the apparatus of claim 1. but fails to teach particular rotational speeds, pressures, and flow rates. Alexander teaches the impeller is configured to provide positive blood flow by rotating at a rotation rate of less than 20,000 RPM , when pumping against a pressure gradient of 100 mmHg ([0009] rotational speeds are generally much slower (2,000-10,000 rpm) than axial flow blood pumps, provide total pressure rise and flow (about 120 mmHg and 5 L/min)). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Calomeni with Alexander because there is some teaching, suggestion, or motivation to do so. Alexander teaches that these parameters are better suited to take over heart function and to provide total pressure rise ([0009]).
Regarding claim 4, Calomeni as modified by Zeng renders obvious the apparatus of claim 1. but fails to teach particular rotational speeds, pressures, and flow rates. Alexander teaches the impeller is configured to provide blood flow of more than 4.5 L/min ([0055] maintain a flow rate of about 5 L/min), when rotating at a rotation rate of less than 20,000 RPM ([0008] Examples of axial rotary pumps (which operate at 10,000-20,000 rpm) are the DeBakey VAD® of MicroMed Cardiovascular, Inc. (Houston, Tex., USA), the FlowMaker® of Jarvik Heart, Inc. (New York, N.Y., USA), formerly known as Jarvik 2000, the HeartMate II of Thoratec Corporation (Pleasanton, Calif., USA), and the Impella Recover® system of Impella CardioSystems AG (Aachen, Germany)), when pumping against a pressure gradient of 50 mmHg ([0055] The mechanical circulation support comprises a centrifugal blood pump configured to provide a pressure rise between about 40 mmHg and about 80 mmHg in the blood flow). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Calomeni with Alexander because there is some teaching, suggestion or motivation to do so. Alexander teaches that treating congestive heart failure in a patient comprises installing a mechanical circulation support within the descending aorta of the patient ([0055]) and the parameters provided are simply the ones that best support that function which the goal of the present invention as well.
Regarding claim 11, Calomeni teaches an apparatus comprising: a blood pump ([0010] catheter blood pump) comprising an impeller ([0010] expandable impeller), the impeller being configured: to be delivered through vasculature of a subject ([0051] deploying a pump portion of a catheter blood pump) while the impeller is in a radially-constrained configuration ([0086] adapted to be collapsed to a delivery configuration so that it can be delivered with a lower delivery profile. The impellers may be attached to drive mechanism 1612) in which the impeller has a diameter ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm, if the deployed diameter is <2mm, then the radially constrained would be much less) but fails to explicitly disclose the impeller diameter in stowed configuration to be less than 2mm.
Zeng, from a similar field of endeavor teaches an impeller assembly having a stored configuration and a diameter that is preferably small enough to be inserted percutaneously into a patient's vascular system [] the impeller 300 can have a diameter in the stored configuration corresponding to a catheter size []about 8 FR [] (para 0045, 8 Fr = 2.7 mm) and when the impeller is positioned within a chamber of the heart it can be advantageous to expand the impeller to have a diameter as large as possible in the expanded or deployed configuration [] the impeller can have a diameter corresponding to a catheter size greater than about 21 FR in the deployed or expanded configuration (para 0046; 21Fr = 7 mm) in order to increase the flow rate of the heart pump while reducing the motor speed (para 0047, 0049). Zeng further teaches that it can be advantageous to make the diameter of the impeller and the cannula as small as possible for insertion into the patient's vasculature (para 0049). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Calomeni with the teachings of Zeng, because doing so would allow for taking advantage of a low profile to provide the predictable result of improving the safely insertion of the pump while increasing the flow rate of the heart pump while reducing the motor speed (para 0050).
It is noted that Calomeni as modified by Zeng do not explicitly disclose the claimed ratio. However, the Calomeni discloses the various expanded diameter while Zeng teaches the stowed dimensions. Zeng further teaches that smaller diameters for the stowed impeller and larger diameters for the deployed impeller are desirable as they would improve insertion and operation. Therefore, the claimed ratio is considered to be disclosed, taught and/or rendered obvious by the combination presented above.
The court has further 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, the specification as originally presented has not provided any evidence that the particular range is critical.
Calomeni as modified by Zeng renders the limitation above obvious but fail to teach particular rotational speeds, pressures, and flow rates. Alexander teaches the impeller is configured to self-expand to a non-radially-constrained configuration, and to pump blood while in the non-radially-constrained configuration by the impeller rotating, the impeller being configured to provide positive blood flow by rotating at a rotation rate of less than 20,000 RPM, when pumping against a pressure gradient of 100 mmHg ([0009] rotational speeds are generally much slower (2,000-10,000 rpm) than axial flow blood pumps, provide total pressure rise and flow (about 120 mmHg and 5 L/min)). It would be obvious to modify with Calomeni with Alexander because there is a teaching, suggestion, or motivation to do so. Alexander teaches that these specifications are “better suited to take over heart function and to provide total pressure rise” ([0009]).
Regarding claim 12, Calomeni as modified by Zeng renders obvious the apparatus according to claim 11. Calomeni fails to teach particular rotational speeds, pressures, and flow rates. Alexander teaches the impeller is configured to provide blood flow of more than 4.5 L/min, when rotating at a rotation rate of less than 20,000 RPM, when pumping against a pressure gradient of 50 mmHg ([0034] generates pressures rises between about 40 to about 80 mmHg and maintains a flow rate of approximately 5 L/min). It would be obvious to modify Calomeni with Alexander because there is a teaching, suggestion, or motivation to do so. Alexander teaches the MCS (with the same specifications as the present invention) is specifically suited for late stage III and/or early stage IV CHF ([0034]).
Regarding claim 13, Calomeni as modified by Zeng and Alexander renders obvious the apparatus according to claim 11. Calomeni further teaches a ratio between (a) a diameter of the impeller when the impeller is in its non-radially-constrained configuration at a location at which the diameter of the impeller is at its maximum ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm) and (b) the diameter of the impeller when the impeller is in its radially-constrained configuration is greater than 7:2 ([0108] This allows it to be delivered using a lower profile delivery device (smaller French size) than would be required if none of working portion 1104 was collapsible, [0159] pigtail catheter can be used to deliver so the size ranges from 6 French to 18 French - 2mm to 6 mm; See rejection of claim 1 or 11 for the ratio; Zeng para 0046-0049).
Regarding claim 14, Calomeni as modified by Zeng and Alexander renders obvious the apparatus according to claim 11. Calomeni further teaches wherein, in its non-radially-constrained configuration, a diameter of the impeller at a location at which a diameter of the impeller is at its maximum is more than 7 mm([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm; See rejection of claim 1 or 11 for the ratio; Zeng para 0046-0049).
Regarding claim 15, Calomeni as modified by Zeng and Alexander renders obvious the apparatus according to claim 14. Calomeni further teaches its non-radially-constrained configuration, the diameter of the impeller at the location at which the diameter of the impeller is at its maximum is more than 8 mm ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm; See rejection of claim 1 or 11 for the ratio; Zeng para 0046-0049).
Regarding claim 16, Calomeni teaches an apparatus comprising:
a blood pump ([0010] catheter blood pump) comprising an impeller ([0010] expandable impeller), the impeller being configured:
to be delivered through vasculature of a subject ([0051] deploying a pump portion of a catheter blood pump) while the impeller is in a radially-constrained configuration ([0086] adapted to be collapsed to a delivery configuration so that it can be delivered with a lower delivery profile. The impellers may be attached to drive mechanism 1612) in which the impeller has a diameter ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm, if the deployed diameter is <2mm, then the radially constrained would be much less) but fails to explicitly disclose the impeller diameter in stowed configuration to be less than 2mm.
Zeng, from a similar field of endeavor teaches an impeller assembly having a stored configuration and a diameter that is preferably small enough to be inserted percutaneously into a patient's vascular system [] the impeller 300 can have a diameter in the stored configuration corresponding to a catheter size []about 8 FR [] (para 0045, 8 Fr = 2.7 mm) and when the impeller is positioned within a chamber of the heart it can be advantageous to expand the impeller to have a diameter as large as possible in the expanded or deployed configuration [] the impeller can have a diameter corresponding to a catheter size greater than about 21 FR in the deployed or expanded configuration (para 0046; 21Fr = 7 mm) in order to increase the flow rate of the heart pump while reducing the motor speed (para 0047, 0049). Zeng further teaches that it can be advantageous to make the diameter of the impeller and the cannula as small as possible for insertion into the patient's vasculature (para 0049). It would have been obvious to one of ordinary skill in the art to modify the disclosure of Calomeni with the teachings of Zeng, because doing so would allow for taking advantage of a low profile to provide the predictable result of improving the safely insertion of the pump while increasing the flow rate of the heart pump while reducing the motor speed (para 0050).
It is noted that Calomeni as modified by Zeng do not explicitly disclose the claimed ratio. However, the Calomeni discloses the various expanded diameter while Zeng teaches the stowed dimensions. Zeng further teaches that smaller diameters for the stowed impeller and larger diameters for the deployed impeller are desirable as they would improve insertion and operation. Therefore, the claimed ratio is considered to be disclosed, taught and/or rendered obvious by the combination presented above.
The court has further 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 experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Here, the specification as originally presented has not provided any evidence that the particular range is critical.
Calomeni as modified by Zeng renders the limitation above obvious but fails to teach particular rotational speeds, pressures, and flow rates. Alexander teaches an impeller being configured to self-expand to a non-radially-constrained configuration, and to pump blood while in the non-radially-constrained configuration by the impeller rotating, the impeller being configured to provide blood flow of more than 4.5 L/min, when rotating at a rotation rate of less than 20,000 RPM, when pumping against a pressure gradient of 50 mmHg ( [0034] generates pressures rises between about 40 to about 80 mmHg and maintains a flow rate of approximately 5 L/min). It would be obvious to modify with Calomeni with Alexander because there is a teaching, suggestion, or motivation to do so. Alexander teaches the MCS (with the same specifications as the present invention) is specifically suited for late stage III and/or early stage IV CHF ([0034]).
Regarding claim 17, Calomeni as modified by Zeng and Alexander renders obvious the apparatus of claim 16. Alexander further teaches the impeller is configured to provide positive blood flow by rotating at a rotation rate of less than 20,000 RPM, when pumping against a pressure gradient of 100 mmHg ([0009] 2,000-10,000 rpm, 120 mmHg and 5 L/min).
Regarding claim 18, Calomeni as modified by Zeng and Alexander renders obvious the apparatus of claim 16. Calomeni further teaches a ratio between (a) a diameter of the impeller when the impeller is in its non-radially-constrained configuration at a location at which the diameter of the impeller is at its maximum ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm) and (b) the diameter of the impeller when the impeller is in its radially-constrained configuration is greater than 7:2 ([0108] This allows it to be delivered using a lower profile delivery device (smaller French size) than would be required if none of working portion 1104 was collapsible, [0159] pigtail catheter can be used to deliver so the size ranges from 6 French to 18 French - 2mm to 6 mm; for ratio, see rejections of independent claims, Zeng, para 0046-0049).
Regarding claim 19, Calomeni as modified by Zeng and Alexander renders obvious the apparatus of claim 16. Calomeni further teaches a diameter of the impeller at a location at which a diameter of the impeller is at its maximum is more than 7 mm ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm see rejections of independent claims, Zeng, para 0046-0049).
Regarding claim 20, Calomeni as modified by Zeng and Alexander renders obvious the apparatus according to claim 19. Calomeni further teaches in its non-radially-constrained configuration, the diameter of the impeller at the location at which the diameter of the impeller is at its maximum is more than 8 mm ([0153] an impeller can have a deployed diameter, shown as Di in fig. 9. In some embodiments Di can be from 1 mm-30 mm, or any subrange therein. For example, in some embodiments Di may be from 1 mm-15 mm, from 2 mm-12 mm, from 2.5 mm-10 mm, or 3 mm-8 mm; see rejections of independent claims, Zeng, para 0046-0049).
Regarding claim 22, Calomeni as modified by Zeng and Alexander renders obvious apparatus of claim 21. Calomeni fails to teach particular rotational speeds, pressures, and flow rates. Alexander teaches the impeller is configured to provide positive blood flow by rotating at a rotation rate of less than 20,000 RPM, when pumping against a pressure gradient of 100 mmHg ([0009] 2,000-10,000 rpm, 120 mmHg and 5 L/min). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Calomeni with Alexander because there is some teaching, suggestion, or motivation to do so. Alexander teaches these specifications are “better suited to take over heart function and to provide total pressure rise” ([0009]).
Regarding claim 23, Calomeni teaches the apparatus of claim 21. Calomeni fails to teach particular rotational speeds, pressures, and flow rates. Alexander teaches the impeller is configured to provide blood flow of more than 4.5 L/min ([0055] maintain a flow rate of about 5 L/min), when rotating at a rotation rate of less than 20,000 RPM ([0008] Examples of axial rotary pumps (which operate at 10,000-20,000 rpm) are the DeBakey VAD® of MicroMed Cardiovascular, Inc. (Houston, Tex., USA), the FlowMaker® of Jarvik Heart, Inc. (New York, N.Y., USA), formerly known as Jarvik 2000, the HeartMate II of Thoratec Corporation (Pleasanton, Calif., USA), and the Impella Recover® system of Impella CardioSystems AG (Aachen, Germany)), when pumping against a pressure gradient of 50 mmHg ([0055] The mechanical circulation support comprises a centrifugal blood pump configured to provide a pressure rise between about 40 mmHg and about 80 mmHg in the blood flow). It would have been obvious to a person having ordinary skill in the art before the effective filing date of this invention to modify Calomeni with Alexander because as shown through the listing of examples in the reference, these specifications for flow rate, rotation rate and pressure gradient are well known in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US20160354525A1 to McBride et al.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANA SAHAND whose telephone number is (571)272-6842. The examiner can normally be reached M-Th 8:30 am -5:30 pm; F 9 am-3 pm.
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, Jennifer S McDonald can be reached at (571) 270- 3061. 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.
/SANA SAHAND/Examiner, Art Unit 3796
Prosecution Insights