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 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.
(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.
Claim(s) 1,8 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Pecor US 2009/0043241, hereafter Pecor, provided in the IDS, hereafter Pecor.
Regarding Claim 1, Pecor discloses A blood pump system (abstract) switchable between a first flow direction and a second flow direction (para. 0049, 0084), the blood pump system comprising: a filter trap (housing [708] comprising membrane [718], where said membrane performs a filtering function [para. 0122-0123]); and a blood pump comprising (pump [32], see para. 0042), where the filtering tube structure may be coupled with the pump (para. 0120): a pump housing comprising: a first connector configured as a fluid inlet into the pump housing in the first flow direction and as a fluid outlet from the pump housing in the second flow direction (inlet [34]); and a second connector in fluid communication with the filter trap, the second connector configured as a fluid inlet into the pump housing in the second flow direction and as a fluid outlet from the pump housing in the first flow direction (outlet [36], where the inlet and out let are interpreted as the first and second connector, respectively, and where the filter is disclosed to connect to the pump). Pecor discloses that various types of pumps may be used (para. 0042) and that the drive means of the pump may be impellers (para. 0049), as such an impeller pump and thus an impeller within a housing is disclosed.
Paragraph 0049 discloses that the pump speed and output is controlled, and that the controller also allows for reversal of the pumping direction. As such it is thus interpreted that the impeller is configured to rotate at a predetermined pump speed in a first rotary direction to generate fluid flow in the first flow direction at a first pressure and a first flowrate (first set pumping speed), the impeller configured to rotate in a second rotatory direction, opposite the first rotary direction, at the predetermined pump speed to generate fluid flow in the second flow direction at a second pressure and a second flowrate (when determined to reverse direction). As the pump controls and regulates the speed of the device, it is interpreted that set speeds may vary. Although there is no specific disclosure that the first flowrate greater than the second flowrate and the first pressure greater than the and the second pressure, the examiner notes that per MPEP Section 2114 [A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Therefore, as Pecor teaches a controller for controlling and regulating pump speeds, where the structural limitations of claim 1 are met by Pecor, and having a first speed be different from a second speed is interpreted to be functional language, Pecor reads to the claimed invention.
Regarding claim 8, Pecor teaches the blood pump system according to claim 1, wherein a product of the first flowrate and the first pressure is different from a product of the second flowrate and the second pressure. The examiner notes that as detailed under the rejection of claim 1, the first and second flowrate were found to be able to be different values. Thus, as the flowrates are different, a product using the individual flow rates would differ between the first and second flowrate.
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) 27-28,31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pecor.
Regarding claim 27, Pecor teaches the blood pump system according to claim 1, but fails to specifically teach wherein the second flowrate is between 30% and 50% of the first flowrate.
Pecor does disclose that the controller controls the operation of the pump (para. 0043 0049) and thus the flow rate as desired. As such the pump speed and thus flow rate is a result effective variable in that flow rate may be adjusted as seen fit. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have a flow rate as claimed, as it involves only adjusting the operation of a parameter disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Pecor by making the second flow rate 30-50% of the first flow, as an operation of the pump, as a matter of routine optimization since it has been 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).
Regarding claim 28, Pecor teaches the blood pump system according to claim 1, wherein the first flowrate is in the range of 2.8 L/min. to 3.5 L/min, and the second flowrate is the range of 1.2 L/min. to 1.5 L/min (para. 0043). Per para. 0043, the pump is sized to generate blood flow in the range of .1 to 3 L/min. While it is not disclosed that the first flow rate is 2.8-3.5 L/min and the second flow rate is 1.2-1.5 L/min, both ranges are overlapping with the suitable operating parameters of Pecor, and thus it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to supply a suitable flow rate between 2.8-3.5 L/min for the first flowrate and a suitable flow rate of between 1.2-1.5 L/min for the second flow rate.
While no pressure values are disclosed, Pecor does teach that the device is configured to provided and insure sufficient flow and pressure (para. 0066), where it is interpreted that operation of the pump to impact flow rate would also impact pressure. As such the pump speed and thus pressure is a result effective variable in that the pump operation and thus pressure may be adjusted as seen fit (insured to be sufficient). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have a pressure as claimed, as it involves only adjusting the operation of a parameter disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Pecor by making the first flowrate pressure of 100-140 mmHg and the second flowrate pressure of 2-10mmHg, per operation of the pump, as a matter of routine optimization since it has been 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).
Regarding Claim 31, Pecor discloses a method of pumping blood in a first direction and a second direction (para. 0049, 0084, where pump is reversible), the method comprising: inserting a first tube into a first blood vessel of a patient (tube [52] para. 0052, figure 1), the first tube fluidly coupled to a blood pump (seen connected to pump 32); inserting a second tube into a second blood vessel of the patient ([tube [50] para. 0052), the second tube fluidly coupled to the blood pump (seen connected to pump 32); operating the blood pump at a first operational pump speed such that blood flows through the blood pump in a first flow direction into the first blood vessel of the patient at a first pressure and a first flowrate (para. 0049, where pump is operated and the speed and thus flow rate (and pressure) is controlled); and operating the blood pump at the first operational pump speed such that blood flows through the blood pump in a second flow direction into the second blood vessel at a second pressure and a second flowrate, the first flowrate greater than the second flowrate and the first pressure greater than the second pressure (where the pump is operated in a pulsatile fashion, and/or the pump speed is controlled by the controller, where the second flow direction is the reverse direction, per para. 0049). While the examiner notes that it is not specifically disclosed that the second flow rate and pressure is different from the first, as the pump speed and thus flowrate and pressure is a result effective variable in that the pump operation and thus flowrate and pressure may be adjusted as seen fit (insured to be sufficient per para. 0063). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device to have a pressure as claimed, as it involves only adjusting the operation of a parameter disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the device of Pecor by making flowrate and pressure in the second direction less than in the first direction, as a matter of routine optimization since it has been 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).
Claim(s) 2-5, is/are rejected under 35 U.S.C. 103 as being unpatentable over Pecor in view of Groß-Hardt et al. US 2017/0087288, hereafter Groß-Hardt, provided in the IDS.
Regarding claim 2, Pecor discloses the blood pump system according to claim 1, wherein the impeller comprises: a body having a first segment and a second segment and a vane extending radially outward from the body and helically wrapped about the second segment of the body. The examiner notes that Pecor is disclosed to use an impeller (para. 0049), where a second embodiment of Pecor specifically depicts the impeller configuration (figure 14). It would therefore have been obvious to one having ordinary skill in the prior to the effective filing date of the claimed invention to use the impeller pumping configuration seen in figure 14 as the pump of the device of Pecor. Doing so would merely involve the simple substitution of one known element for another to obtain predictable results (that being pumping of blood through the system), and thus a prima facie case of obviousness exists. However, the examiner notes that the disclosure and figures of Pecor are not clear to define a first and second segment and a vane. As such the examiner relies on Groß-Hardt.
Groß-Hardt teaches an impeller blood pump and is thus considered analogous to the claimed invention. Groß-Hardt teaches that the impeller comprises a first and second segment (where the first segment is interpreted to be the thicker portion comprising the motor [40] seen in figure 1 and the second segment is the hub [33].) The examiner further notes that vanes (35) can be seen attached to the hub (33) and thus are attached to the second segment, and that the vanes may be raked and/or various shapes (para. 0043). Therefore, as Pecor teaches that an impeller pump is suitably used in the system, and Groß-Hardt teaches a suitable impeller structure comprising a first and second segment and vanes, for an impeller, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the impeller structure of Groß-Hardt as the impeller structure of Pecor. Doing so would merely require the simple substitution of one known element for another to obtain predictable results, that being functioning as an impeller pump, and thus a prima facie case of obviousness exists.
Regarding claim 3, Pecor and Groß-Hardt teach the blood pump system according to claim 2, wherein the vane has a rake such that radially outer parts of the vane are farther from the first segment than radially inner parts of the vane. The examiner notes that as detailed under the rejection of claim 2, Groß-Hardt teaches that the vanes may be raked.
Regarding claim 4, Pecor and Groß-Hardt teach the blood pump system according to claim 2, wherein the vane helically wraps about the second segment of the body with a variable pitch such that parts of the vane closer to the first segment have a lesser pitch than parts of the vane farther from the first segment (Groß-Hardt figure 1, para. 0043, provided in the rejection of claim 2). The examiner notes that as seen in Groß-Hardt, the vanes helically wrap around the second segment where the pitch (interpreted as the direction/bending) of the rake is seen to change along the length.
Regarding claim 5, Pecor and Groß-Hardt teach the blood pump system according to claim 2, wherein the second segment is frustoconically shaped (figure 1 of Groß-Hardt, see also figure 3A). While the first segment of Groß-Hardt is not taught to be egg shaped, this portion merely comprises the motor. Per MPEP Section 2144 IV B, In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.) The examiner notes that as modifying the motor comprising portion to be egg-shaped, in the examiner’s opinion, would not have an impact on the function of the pump, as the motor would still be able to function, one having ordinary skill in the art prior to the effective filing date of the claimed invention would have found it obvious to modify the shape of the first segment of Groß-Hardt to be egg0shaped, as a matter of an obvious change in shape.
Claim(s) 6,10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pecor in view of Ellingboe et al. US 2002/0085952, hereafter Ellingboe.
Regarding claim 6, Pecor teaches the blood pump system according to claim 1, but fail to teach wherein the filter trap includes a one-way valve configured to remain closed when fluid flows through the pump housing in the first flow direction and to open when fluid flows through the pump housing in the second flow direction.
Ellingboe teaches a blood treatment system and is thus considered analogous to the claimed invention. Ellingboe teaches that a tubing line is connected to a bubble trap (152) where the bubble trap may include a filter screen (200) and a vent (one way valve) (para. 0163). Therefore, as Ellingboe teaches that traps including a filter may further include a valve, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the housing (708 of Pecor) comprising the filter (membrane 718, where the construction is interpreted as the trap per the rejection of claim 1), with a valve, as Ellingboe teaches that traps including filter may further include a one-way valve. Doing so would merely involve combining prior art elements according to known methods to yield predictable results, that being the construction of a trap, and thus a prima facie case of obviousness exists.
Regarding claim 10, Pecor and Ellingboe teach the blood pump system according to claim 6, wherein the filter trap comprises: a housing (708 of Pecor); a first trap connector (first port 716); a second trap connector (second port 720); a perforated wall disposed within the housing (membrane 718), the perforated wall defining an interior chamber and an exterior chamber within the housing (space inside [708] being the interior chamber, and the portion outside the housing [708] and connected with [802] is interpreted as the exterior chamber, within the housing when connected with [802]; and the one-way valve segregating the interior chamber into an inlet section and a trap house. The examiner notes that in the obvious combination with Ellingboe, a valve was found obvious to include in the filter trap. As the valve is a one-way valve, one side of the valve would be the inlet section and the other side of the valve is interpreted as the trap house.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pecor in view of Ellingboe and further in view of Kapur et al. US 2021/0077792, hereafter Kapur.
Regarding claim 12, Pecor and Ellingboe teach the blood pump system according to claim 10, wherein the one-way valve is attached to the perforated wall. While the examiner notes that the valve and defined perforated wall are in fluid communication with one another, it is not disclosed that the valve is attached to the perforated wall. However, per MPEP section 2144 IV C, In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). Therefore, as modifying the position of the valve to be attached to the filter would still allow fluid to flow and allow both the valve and the filter to function, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to provide the valve on the perforated wall.
Regarding the limitation that the valve comprises two flexible members, the prior art applied is silent.
Kapur teaches a blood flow system and is thus considered analogous to the claimed invention. Kapur teaches a flow limiting relief valve used in the system (para. 0179-0184, see figures 34a-b), where said valve, seen in 34b has two flaps that remain substantially closed until a substantial force is applied (para. 0182). Per the same citation, the flaps are elastic and return to the closed position. Therefore, as Kapur teaches that flow limiting valves in a blood treatment system may be made from a two-flap configuration, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the valve configuration of Kapur as the valve configuration of the previous prior art configuration. Doing so would merely involve the simple substitution of one known element for another to obtain predictable results, that being flow limitation, and thus a prima facie case of obviousness exists.
Regarding claim 13, Pecor, Ellingboe, and Kapur teach the blood pump system according to claim 12, wherein the two flexible members are self-biased towards to the closed position (see rejection of claim 12, in view of Kapur).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pecor in view of Ellingboe and Kapur, and further in view of Brugger US 5503801, hereafter Brugger.
Regarding claim 14, Pecor, Ellingboe, and Kapur teach the blood pump system according to claim 12, but fails to teach wherein the perforated wall includes a first perforated portion and a second perforated portion, the first perforated portion separated from the second perforated portion by an unperforated portion.
Brugger teaches a blood trap apparatus and is thus considered analogous to the claimed invention. Brugger teaches a filter within said trap (filter 96) comprising perforations (100). As seen in figure 8 the wall (98) of the filter comprises solid components between adjacent perforations (see annotated figure below). Therefore, as Brugger teaches a perforated filter in the style taught in Brugger is suitable in a blood system trap, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the filter of Brugger for the filter of Pecor. Doing so would merely require the Simple substitution of one known element for another to obtain predictable results (that being filtering of material), and thus a prima facie case of obviousness exists.
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Regarding claim 19, Pecor, Ellingboe, Kapur, and Brugger teach the blood pump system according to claim 14, wherein the perforated wall includes a third perforated portion configured to place the exterior chamber and the inlet section in direct fluid communication see Brugger figure 9, where the filter allows blood to flow from the perforations through the exit (88’, column 8, lines 21-30). Thus, it is interpreted that the open bottom of the filter is a third perforated portion communicating the exterior chamber and the inlet section.
Regarding claim 22, Pecor, Ellingboe, Kapur, and Brugger teach the blood pump system according to claim 1, further comprising a first tube (Pecor 52)fluidly coupled to the pump housing about the first connector and a second tube (Pecor 50) fluidly coupled to the pump housing about the second connector, the first tube configured to fluidly couple to a first blood vessel of the human body and the second tube configured to fluidly couple to a second blood vessel of the human body (para. 0052, 0062). The examiner notes that as seen in figure 1 of Pecor, both the defined first and second tubes connect to the pump, thus through the defined connectors.
Allowable Subject Matter
Claims 15-18 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:
Regarding claim 15, Pecor, Ellingboe, Kapur, and Brugger teach the blood pump system according to claim 14, wherein the two flexible members each include a wall engagement portion (connected to the wall as seen in Brugger) but fails to teach the wall engagement portions are configured to engage the unperforated portion when the two flexible members are in the open position. The examiner notes at best, the rearrangement of parts configuration can position the flexible members to engage with the filter (perforated component), but it would not have been obvious to one having ordinary skill in the art to specifically configure the valves to, when open, connect to the unperforated portion of the filter of Brugger, given that the unperforated portion is too small to reasonably support and end of the valve, and the valve positioning ins said location (in view of Brugger), would not likely allow the valve to elastically go back to is closed position. The examiner notes that in an updated search, not prior art was found to read to this limitation, best seen in figure 7 of the instant application. The prior art applied remains the closest.
Claims 16-18 are objected to as being dependent on claim 15. However, the examiner found no further art to read on said claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781
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