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 .
Claim Objections
Claim 5 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claims 11-13 are objected to under 37 CFR 1.75 as being a substantial duplicate of claims 17-19. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13, 15, and 17-20 rejected under 35 U.S.C. 101 because Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-13, 15, and 17-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 1, 14 and 17 states “wherein the measurement locations of the plurality of sensors are spaced apart from one another along the tube such that, when the tube is in the proper position within the heart and the pulmonary artery, at least one measurement location is within each of a right atrium, a right ventricle, and the pulmonary artery”;
Claims 6 and 15 state “a first port at a first measurement location within the pulmonary artery when the tube is in the proper position within the heart and the pulmonary artery; “a second port at a second measurement location within the right ventricle when the tube is in the proper position within the heart”; “a third port at a third measurement location within the right atrium when the tube is in the proper position within the heart”.
Thus, these claims include a human within the scope and are non-statutory.
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.
Claim(s) 1-5, 14, and 16 is/are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Aboul-Hosn et al (US Publication 2005/0279370).
Referring to Claim 1, Aboul-Hosn et al teaches a right ventricular assist device for placement at least partially inside a heart and a pulmonary artery of a mammalian subject, the right ventricular assist device comprising: a tube having an inlet configured to be positioned within the mammalian subject when the tube is in a proper position within the mammalian subject and an outlet configured to be located in the pulmonary artery when the tube is in the proper position (e.g. Figure 14, tube 70); a pump connected to the inlet and configured to pump blood from the inlet to the outlet (e.g. Paragraph [0069] and Figures 14 and 19); a plurality of sensors having measurement locations along the tube to measure a plurality of pressures of blood exterior to the tube at the measurement locations, wherein the measurement locations of the plurality of sensors are spaced apart from one another along the tube such that, when the tube is in the proper position within the heart and the pulmonary artery, at least one measurement location is within each of a right atrium, a right ventricle, and the pulmonary artery (e.g. Paragraph [0103] discloses multiple pressure transducers are used along the length of the cannula); a controller in communication with the pump and the plurality of sensors, wherein the plurality of sensors convey the plurality of pressures to the controller, and wherein the controller is configured to instruct the pump to pump blood through the tube depending on at least one of the plurality of pressures (e.g. Paragraph [0066] discloses a controller controls the pump in response to measurement of blood pressure transducer).
Referring to Claim 2, Aboul-Hosn et al teaches the right ventricular assist device of claim 1, wherein the controller is configured to instruct the pump to vary a flow rate of blood pumped through the tube (e.g. Paragraph [0066]).
Referring to Claim 3, Aboul-Hosn et al teaches the right ventricular assist device of claim 2, wherein the controller is configured to instruct the pump to vary the flow rate of blood to maintain a first pressure representing a pressure of blood in the pulmonary artery above a first threshold pressure, and wherein the controller is configured to instruct the pump to vary the flow rate of blood to maintain a first pressure representing a pressure of blood in the pulmonary artery below a second threshold pressure (e.g. Paragraph [0066]).
Referring to Claim 4, Aboul-Hosn et al teaches the right ventricular assist device of claim 1, wherein the inlet is configured to be positioned within a right ventricle or a right atrium of the heart (e.g. Figure 14).
Referring to Claim 5, Aboul-Hosn et al teaches the right ventricular assist device of claim 1, wherein the plurality of pressure sensors comprises: a first sensor positioned along the tube adjacent the outlet, the first sensor configured to be located within the pulmonary artery when the tube is in the proper position within the heart and the pulmonary artery and measure a first pressure of the plurality of pressures (e.g. Paragraph [0103]); a second sensor positioned along the tube distant from the first sensor, the second sensor configured to be located within the right ventricle when the tube is in the proper position within the heart and the pulmonary artery and measure a second pressure of the plurality of pressures (e.g. Paragraph [0103]); a third sensor positioned along the tube distant from the first sensor and the second sensor, the third sensor configured to be located within the right atrium when the tube is in the proper position within the heart and the pulmonary artery and measure a third pressure of the plurality of pressures (e.g. Paragraph [0103]).
Referring to Claim 14, Aboul-Hosn et al teaches a right ventricular assist device for placement at least partially inside a heart and a pulmonary artery of a mammalian subject, the right ventricular assist device comprising: a tube having an inlet configured to be positioned within the mammalian subject when the tube is in a proper position within the mammalian subject and an outlet configured to be located in the pulmonary artery when the tube is in the proper position (e.g. Figure 14, tube 70); a pump connected to the inlet and configured to pump blood from the inlet to the outlet (e.g. Paragraph [0069] and Figures 14 and 19); a first sensor positioned along the tube adjacent the outlet, the first sensor configured to be located within the pulmonary artery when the tube is in the proper position within the heart and the pulmonary artery and measure a first pressure of blood exterior to the tube at a first measurement location of the first sensor (e.g. Paragraph [0103]); a second sensor positioned along the tube distant from the first sensor, the second sensor configured to be located within the right ventricle when the tube is in the proper position within the heart and the pulmonary artery and measure a second pressure of blood exterior to the tube at a second measurement location of the second sensor (e.g. Paragraph [0103]); a third sensor positioned along the tube distant from the first sensor and the second sensor, the third sensor configured to be located within the right atrium when the tube is in the proper position within the heart and the pulmonary artery and measure a third pressure of blood exterior to the tube at a third measurement location of the third sensor (e.g. Paragraph [0103]); a controller in communication with the pump, the first sensor, the second sensor, and the third sensor, wherein the first sensor, the second sensor, and the third sensor convey measurements of the first pressure, the second pressure, and the third pressure, respectively, to the controller and the controller is configured to instruct the pump to pump blood through the tube depending on at least one of the measurements of the first pressure, the second pressure, and the third pressure (e.g. Paragraph [0066] discloses a controller controls the pump in response to measurement of blood pressure transducer).
Referring to Claim 16, Aboul-Hosn et al teaches the right ventricular assist device of claim 14, wherein the controller is configured to instruct the pump to vary the flow rate of blood to maintain a first pressure representing the pressure of blood in the pulmonary artery above a first threshold pressure, and wherein the controller is configured to instruct the pump to vary the flow rate of blood to maintain a first pressure representing the pressure of blood in the pulmonary artery below a second threshold pressure (e.g. Paragraph [0066]).
Allowable Subject Matter
Claim 17-20 are allowed over the prior art, but are rejected under 101 as identified above.
Claims 6-13 and 15 are currently rejected under 101. However, no prior art was found teaching individually, or suggesting in combination, all of the features of the claims.
The following is a statement of reasons for the indication of allowable subject matter: No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically a first spacer positioned along the tube and configured to be between the pulmonary artery and the right ventricle when the tube is in the proper position, the first spacer configured to plug a gap in the pulmonary valve; a second spacer positioned along the tube and configured to be between the right ventricle and the right atrium when the tube is in the proper position, the second spacer configured to plug a gap in the tricuspid valve (claims 11 and 17); a first, second and third port and a first, second and third lumen extending at least partially within the tube from the first, second and third port (claim 6) and in combination with the recited structural limitations of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Menon et al (US Publication 2020/005943) discloses a cannula with three pressure sensors (e.g. Figure 4) and where flow rate of blood being drained is determined.
Aboul-Hosn et al (US Patent 6,295,877) discloses a pressure sensing cannula with multiple transducers along the length.
Tuval et al (US Publication 2020/0237986) discloses a ventricular assist device with multiple sensors on the outer surface of a tube and controls the pumping of blood in response to the measure blood pressure.
Treu et al (US Publication 2023/0211059) discloses an extracorporeal blood processing flow balancing device with multiple pressure transducers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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/William J Levicky/Primary Examiner, Art Unit 3796
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