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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: inlet valve 620 and outlet valve 630. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “pneumatic pressure pump disposed in a connection pipe that connects the blood pump and the oxygenator and is configured to form vacuum in the blood pump by sucking the gas supplied to the blood pump” in claim 13 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-19 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.
Regarding claim 1, “a pump” in lines 5 and 7 renders the claim indefinite, as it is unclear whether these are the same pumps as each other and whether they are the same as the “a blood pump” in line 1. For examination purposes, these are interpreted as the same, especially as Figure 1 shows them all as the parts of the same blood pump 100.
Claims 2-19 are rejected as dependents of claim 1.
Regarding claim 6, the limitation “a pump” in lines 1 and 2 renders the claim indefinite as it is unclear whether this is the same or different than pump in claim 1. For examination purposes this is interpreted as the same. Additionally, the limitation “the gas inflow/outflow” in line 3 renders the claim indefinite as it is unclear how the gas inflow/outflow port of claim 1, which the outer wall of a blood chamber is configured to have, is also on a different part , being the inlet valve or the outlet valve. For examination purposes, “the gas inflow/outflow port” of line 3 in claim 6 is considered a different gas inflow/outflow port than that of the outer wall.
Claims 7-9 are rejected as dependents of claim 6.
Regarding claim 10, the limitation “a pump” in lines 2-3” renders the claim indefinite as it is unclear whether this is the same or different than pump in claim 1. For examination purposes this is interpreted as the same.
Regarding claim 11, the limitation “the valves” in the last line of the claim renders the claim indefinite, as it is unclear which valves are being referred to. For examination purposes, this limitation is interpreted as “the plurality of valves.”
Claims 12-19 are rejected as dependents of claim 11.
Claim 12 recites the limitation "the plurality of blood pumps" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 13, the limitation “a connection pipe” in line 2 renders the claim indefinite, as it is unclear whether this is the same or different than that of claim 1.
Regarding claim 15, the limitation “a pump” in line 2 renders the claim indefinite as it is unclear whether this is the same or different than pump in claim 1. For examination purposes this is interpreted as the same.
Claim 16 is rejected as a dependent of claim 15.
Regarding claim 16, the limitation “the valve” is indefinite as it is unclear which valve is being referred to.
Regarding claim 17, the limitation “a pump” in lines 3-4 renders the claim indefinite as it is unclear whether this is the same or different than pump in claim 1. For examination purposes this is interpreted as the same. Additionally, the limitation “an inlet valve” in line 5 renders the claim indefinite as it is unclear whether it is the same or different than the “an inlet valve” of claim 1 and “an outlet valve” in line 9 renders the claim indefinite as it is unclear whether it is the same or different than the “an outlet valve” in claim 1. For examination purposes, as Figure 13 shows these to be different, they are interpreted as being different.
Claims 18-19 are rejected as dependents of claim 17.
Claim 18 recites the limitation "the operation" in line 3. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, “the operation” is interpreted as “the series of operations.” Additionally, the limitation “a pump” in lines 4, 8, 10, and 14 renders the claim indefinite as it is unclear whether this is the same or different than pump in claim 1. For examination purposes this is interpreted as the same.
Claim 19 is rejected as a dependent of claim 18, and as it includes “the operation”.
Claim 19 recites the limitation "the number of repetitions" in line 3 and “the basis” in line 3. There is insufficient antecedent basis for these limitations in the claim.
Claim Rejections - 35 USC § 102
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 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 and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lim et al. (KR 101882479). While a copy and translation of Lim has been provided by applicant, all citations to the Description section below are to the translation provided with this office action.
Regarding claim 1, Lim discloses a blood pump (see Figs. 2-4) forcing blood to flow in one direction (see par. 40), comprising: a blood chamber comprising an outer wall 100 configured to have a gas inflow/outflow port 130 formed at one end thereof and a pouch (see Figs. 2-3, par. 28 bag 200 shown in Fig. 3 is accommodated inside housing 100) inserted into the outer wall (see par. 28) and configured to have both ends coupled to both ends of the outer wall, respectively (see Figs. 2, 3; par. 29, 32, 38); an inlet valve 300 for a pump coupled to one end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood to the blood chamber (see par. 35, 41-42); and an outlet valve 400 for a pump coupled to the other end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood from the blood chamber (see oar. 35, 50-51).
Regarding claim 2, Lim discloses in the blood chamber, a pneumatic pressure is formed between the outer wall and the pouch by a gas that is introduced and discharged through the gas inflow/outflow port 130 (see par. 28, 31-32).
Regarding claim 3, Lim discloses the blood chamber, an outward form of each of the outer wall and the pouch is a bent pipe shape (see Fig. 2).
Regarding claim 4, Lim discloses one side of the pouch is deformed by pneumatic pressure so that a flow of blood is formed (see Pr. 28, 30-32).
Regarding claim 5, Lim discloses the pouch 200 is formed in a hollow form (see Fig. 3) having an elastic restoring force (par. 33, can be relaxed and contracted and par. 38, flexible material).
Regarding claim 10, Lim discloses a connection unit 120, 110 configured to have both ends coupled to the blood chamber and the inlet valve for a pump or the outlet valve for a pump (see Figs. 2-3), respectively, and to have an internal diameter that is increased from an end of the connection unit coupled to the inlet valve for a pump or the outlet valve for a pump toward an end of the connection unit coupled to the blood chamber (see Figs. 2-3).
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 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, 6, and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johns et al. (US 2019/0358375) in view of Kato et al. (US 6,123,519).
Regarding claim 1, Johns discloses a blood pump forcing blood to flow in one direction (see Figs. 1-3, par. 49-50), comprising: a blood chamber (see Fig. 3, blood 16 goes into pump apparatus) comprising an outer wall (see Fig. 3, outside wall like outer duct 11 in Fig. 2) configured to have a fluid inflow/outflow port formed at one end thereof (see Fig. 3, port above compression of main chamber to eject blood, which is like fluid port 15 in Fig. 2) and a pouch 200 inserted into the outer wall and configured to have both ends coupled to both ends of the outer wall, respectively (see Fig. 3); an inlet valve 23 for a pump coupled to one end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood to the blood chamber (see Fig. 3, par. 50); and an outlet valve 24 for a pump coupled to the other end of the blood chamber in a way that a fluid communicates therewith and configured to block a flow of blood from the blood chamber (see Fig. 3, par. 50).
Johns does not disclose the fluid inflow/outflow port being a gas inflow/outflow port, though Johns discloses the pumping liquid can be any suitable non-toxic liquid such as saline solution, water or silicone oil (see par. 38).
Kato discloses it is well known for a fluid pump to use liquid, such as saline or water, or gas into and out of the pumping means to intermittently repeat inflow and outflow of the fluid (see col. 16, lines 61-64). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the inflow/outflow port be a gas inflow/outflow port, Kato disclosing such a known alternative of the saline or water disclosed by Johns and using gas would predictably result in the inflow/outflow material to help with the pumping via providing gas into and out of the pouch.
Regarding claim 6, Kato and Johns disclose the limitations of claim 1 and Johns discloses the inlet valve for a pump or the outlet valve for a pump further comprises: a valve outer wall having the gas inflow/outflow port formed at one end thereof (see Fig. 3, port with arrow going in, as with valve 23, or other port with arrow going out, as with valve 24, showing fluid flowing into or out of valve and port is on each outer wall of each valve); and a valve pouch inserted into the valve outer wall and configured to have both ends coupled to both ends of the valve outer wall, respectively (see Fig. 3, inside of valves that move to allow valve to open and close).
Regarding claim 8, Kato and Johns disclosed the limitations of claim 6, and Johns further discloses one side of the valve pouch is deformed by pneumatic pressure so that a flow of blood is blocked (see Fig. 3, par. 50).
Regarding claim 9, Kato and Johns disclosed the limitations of claim 6, and Johns further discloses the valve pouch is formed in a hollow form having an elastic restoring force (see Fig. 3, par. 11, 50).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johns in view of Kato as applied to claim 1 above, and further in view of Chmiel (US 4,008,710).
Regarding claim 7, Johns and Kato discloses the limitations of claim 6 but do not disclose an outward form of each of the valve outer wall and the valve pouch is a bent pipe shape.
Chmiel discloses a pump with an outlet valve bent shape having a pouch 14 and outer wall 10, wherein the outer wall 10 connects to an oxygenator (see Fig. 1; col. 3, lines 42-48). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the blood pump have the valve outer wall and valve pouch be a bent pipe shape, as disclosed by Chmiel, this shape being a well known alternative for allowing for connection to an oxygenator, such connection shown as desirable by Johns (see par. 21, pump in ECMO, which would require oxygenator), and predictably resulting in valve allowing for inflow/outflow to help with pumping blood.
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johns in view of Kato as applied to claim 1 above, and further Brady et al. (US 2011/0129389) in view of Fischel (US 3,877,843) and in view of Orr (US 2009/0137940).
Regarding claim 11, Johns and Kato disclose the blood pump according to claim 1 and Johns further discloses a blood oxygenation system comprising the blood pump (see par. 21) and an oxygenator configured to oxidize blood (see par. 21, for oxygenation needs an oxygenator in ECMO system), but they do not disclose an oxygenator configured to oxidize blood that is circulated by the blood pump.
Brady discloses that in an ECMO system, a blood pump is used to pump blood to the oxygenator (see Fig. 1, par. 10),the pump maintaining pressure and flow of ECMO system (see par. 9). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the blood oxygenation system have the oxygenator configured to oxidize blood that is circulated by the blood pump, as Brady discloses in an ECMO system that the pump maintains pressure and flow, including the flow to the oxygenator, therefore providing blood flow to the oxygenator in the ECMO system of Johns and Kato.
Johns, Kato, and Brady do not disclose a pressure tank configured to accommodate compressed gas and a connection pipe that is a moving passage of the gas and configured to connect the blood pump and the pressure tank or the oxygenator; a plurality of valves disposed in the connection pipe and configured to control a flow of the gas that is introduced and discharged through the blood pump; and a controller configured to control an operation of the blood pump by opening and closing the valves.
Fischel discloses a pulsatile pumping system 16 (see Fig. 1) that includes a pressure tank 82 configured to accommodate a compressed gas to drive the pump (see Fig. 1, col. 4, lines 12-15) and associated connection pipe (see Fig. 1, connection pipe between pressurized air and pump 54) that is a moving passage of the gas (see Fig. 1, pressurized air 82 travels through pipe) and configured to connect the blood pump and pressure tank (see Fig. 1); a plurality of valves 110, 144, 132, 140 that are open and closed and are disposed in the connection pipe and configured to control a flow of the gas that is introduced and discharged through the blood pump (see col. 4, line 48-col. 5, line 29). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further include the pressure tank, connection pipe, and plurality of valves helping to drive the pulsatile system, as disclosed by Fischel, in order to supply the gas for pumping blood.
Orr discloses a controller configured to control operation of valves in a blood pumping assembly (see par. 309, 326). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to further include a controller as disclosed by Orr configured to control an operation of the blood pump by controlling the flow control valves, as disclosed by Orr, in order to more easily control the system.
Regarding claim 12, Johns, Kato, Brady, Fischel, and Orr disclose the blood oxygenation system of claim 11 but as described above do not disclose the blood oxygenation system comprises the plurality of blood pumps, and the controller controls the plurality of blood pumps so that blood is discharged from some of the plurality of blood pumps and blood is introduced into remaining blood pumps of the blood plurality of blood pumps.
In a different embodiment as described above, Johns discloses that improved control of flow can be achieved with two pumps in parallel and working 180 degrees out of phase (see par. 48). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the blood pumps be a plurality as disclosed by Johns in order to have improved control of flow. Additionally, duplication of parts has been found to be obvious absent new and unexpected results. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). Consequently, one of ordinary skill in the art before the effective filing date of the claimed invention would have found duplication of the blood pumps to be obvious.
Orr discloses a controller configured to control operation of valves in a blood pumping assembly, the controller controlling multiple pumps (see par. 309, 326). Consequently, it would have been obvious to a person having ordinary skill in the art for multiple pumps to be controlled by the controller, as disclosed by Orr, in order to more easily control the system. Furthermore, as Johns discloses the two pumps in parallel and working 180 degrees out of phase, blood would be discharged form some of the plurality of blood pumps and introduced into remaining blood pumps of the plurality of blood pumps.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johns in view of Kato in view of Brady in view of Fischel and further in view of Orr as applied to claim 11 above, and further in view of Grant et al. (US 2008/0216898)
Regarding claim 15, Johns, Kato, Brady, Fischel, and Orr disclose the limitations of claim 11 but do not disclose a plurality of pressure sensors disposed in the blood chamber, the inlet valve for a pump, and the outlet valve for a pump, respectively.
Grant discloses pressure valves used to operate the pumps located at different points in the flow path and pressure control using a pressure sensor at each pump chamber which requires pressure control (see par. 231). Consequently, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have a pressure sensor at each pump chamber, which would include the blood chamber, inlet valve, and outlet valve, in order to help with pressure control of the pump.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johns in view of Kato in view of Brady in view of Fischel in view of Orr and further in view of Grant as applied to claim 15 above, and further in view of Robinson et al. (US 5,423,738).
Regarding claim 16, Johns, Kato, Brady, Fischel, Grant, and Orr disclose the limitations of claim 15 but do not disclose the controller determines whether the valve has failed based on pressure measured by the pressure sensor in a preset condition.
Robinson discloses a blood pumping and processing system where the controller monitors pressure thresholds and limits and pinpoints potential failures (see col. 28, lines 41-48). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have the controller monitor the pressure from the pressure sensors and compare to a pressure limit/threshold to determine failures, as disclosed by Robinson, in order to help with monitoring the system.
Allowable Subject Matter
Claims 13-14 and claims 17-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 for claims 13 and 14: the closest prior art found is Johns, Kato, Brady, Fischel, and Orr, which do not disclose a connection pipe that connects the blood pump and the oxygenator and is configured to form vacuum in the blood pump by sucking the gas supplied to the blood pump, or oxygen moved from the pressure tank to the blood pump and form the blood pump to the oxygenator through the connection pipe. In applicant’s invention, oxygen is moved throughout the system, helping to pump the blood pump and oxygenate via the oxygenator via a connection between the blood pump and the oxygenator. None of the prior art found has such a connection. Furthermore, while Mechanika (GB 1,046,098) discloses supplying oxygen via the same tank to help pump the blood pumps and supply and oxygenator with blood, these connections to the blood pumps and the oxygenator are separate connections that would not allow for oxygen to move between the blood pump and the oxygenator.
The following is a statement of reasons for the indication of allowable subject matter for claims 17-19: the closest prior art found is Johns, Kato, Brady, Fischel, and Orr, which do not disclose the required third connection valve having one end connected to the outlet valve for the pump, with the third inlet valve having both ends connected to the pressure tank and the third connection valve, respectively, and the third outlet valve having both ends connected to the oxygenator and the third connection valve, respectively. In applicant’s invention, this allows for a connection between the tank, blood pump, and oxygenator. None of the prior art found has such a connection. Furthermore, while Mechanika (GB 1,046,098) discloses supplying oxygen via the same tank to help pump the blood pumps and supply and oxygenator with blood, these connections to the blood pumps and the oxygenator are separate connections that would not allow for oxygen to move between the blood pump and the oxygenator.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARIANA ZIMBOUSKI whose telephone number is (303)297-4665. The examiner can normally be reached 8:30 - 5:00 PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, REBECCA E EISENBERG can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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