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
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) 1-3, 5, 8-11, and 13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Skudas (US20130280788A1).
Regarding claim 1, Skudas teaches a fluid supply device for providing a mobile phase for a sample separating device, the fluid supply device comprising: {[0025] re. solvent delivery system and separation unit} a supply path configured to provide a fluid for forming at least a part of the mobile phase; {[0025] re. lines for liquid between separation units and the solvent delivery system} a fluid conveying unit configured to receive and pressurize the fluid from the supply path and to convey the fluid to the sample separating device; {[0101] re. pump and reservoir for delivery of a liquid to separation system} and a sterile filter disposed in the supply path upstream of the fluid conveying unit and configured to filter the fluid. {[0050] re. sterile filters & Figure 15 re. sterile filter upstream of the chromatography/separation device of the taught invention}
Regarding claim 2, Skudas teaches a fluid source configured to provide a solvent as the fluid to the supply path. {[0099] re. solvent reservoir}
Regarding claim 3, Skudas teaches wherein the sterile filter has a pore size selected from the group consisting of: a pore size effective for blocking passage of microorganisms in the fluid; a pore size of 1 μm or less; a pore size of 0.5 μm or less; and a pore size of 0.1 μm or less. {[0050] re. sterile filters & Figure 15 re. sterile filter upstream of the chromatography/ separation device of the taught invention} Given the function of sterile filters to remove microorganisms and fine particulates, the disclosed sterile filter upstream of the separation process would be "effective for blocking passage of microorganisms".
Regarding claim 5, Skudas teaches a pre-filter pump disposed in the supply path and configured to push the fluid through the sterile filter and toward the fluid conveying unit. {[0101] re, the pumps of the reservoirs can be used to mix two or more liquid streams coming from two or more reservoirs (prior to the sterile filter)}
Regarding claim 8, Skudas teaches a pressure control device configured to control pressure in the supply path imparted to the sterile filter. {[0211-0212 re. detectors and they computer system capable of connecting to the pumps and valves to monitor and adjust the system in real time based on in-line measurements}
Regarding claim 9, Skudas teaches wherein the pressure control device comprises at least one of: a pressure relief device configured to divert at least a portion of the fluid in the supply path outputted from the pre-filter pump away from the sterile filter; a flow sensor configured to measure a flow characteristic of the fluid outputted from the pre-filter pump, {[0223] re. the flow of the feed is controlled} wherein the pre-filter pump is controlled based on the measured flow characteristic. {[0211-0212 re. detectors and the computer system capable of connecting to the pumps and valves to monitor and adjust the system in real time based on in-line measurements}
Regarding claims 10 and 11, Skudas teaches a buffer unit {[0217] re. buffer reservoirs and pumps} (Claims 10 and 11) disposed in the supply path between the sterile filter and the fluid conveying unit, the buffer unit configured to buffer the fluid. {Figure 15 re. "salt addition" (buffer) step, wherein the salt addition occurs between the sterile filter and separation step} (Claims 10 and 11) Note dependent claims 10-11 are identical in language, hence why they were rejected together. Due to their different dependencies, the claims are in proper form.
Regarding claim 13, Skudas teaches a fluid valve switchable between a first state at which the fluid valve enables a passing of the fluid from the supply path toward the fluid conveying unit, and a second state at which the fluid valve prevents the passing of the fluid from the supply path toward the fluid conveying unit. {[0025] re. each branch having an on/off valve}
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 4 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skudas (US20130280788A1), as applied to the claims above.
Regarding claim 4, Skudas teaches a high-pressure fluid path through which the fluid conveying unit conveys the fluid to the sample separating device, {[0221] re. high-pressure pumps} wherein the supply path is a low-pressure fluid path relative to the high-pressure fluid path. {[0221] re. low-pressure pumps}
Skudas fails to teach that the supply path is a low-pressure fluid path relative to the high-pressure fluid path, however, the claimed fluid flow paths are capable of performing in a high pressure environment (high-pressure fluid flow path) and low pressure environment (supply path).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to recognize the high and low pressure capabilities within the taught flow path of Skudas as MPEP § 2114 (II) recites, "[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.
Regarding claim 12, Skudas teaches wherein the buffer unit comprises a sensor unit configured to detect a sensor information related to the fluid in the supply path. {[0211] re. analysis of sample quality and monitoring through detectors}
Skudas is silent to the sensor unit being located in the buffer unit. However, Skudas teaches that detectors may be placed in any suitable location. {Skudas, [0211]}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to include a sensor in the buffer unit, especially a pH sensor (which is disclosed as a type of detector in [0211]), as buffers typically stabilize the pH of a system, and including operational parameter monitoring system is well known to will increase the accuracy and efficacy of a separation system.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skudas (US20130280788A1), as applied to the claims above, in view of Vorm (US20200041467A1).
Regarding claims 6 and 7, Skudas fails to teach wherein the pre-filter pump is configured to pressurize the fluid at a lower pressure than the fluid conveying unit; (Claim 6) and comprising one of: the pre-filter pump is configured to pressurize the fluid to a pressure in a range from 1.2 bar to 3 bar; the pre-filter pump is configured to pressurize the fluid to a pressure in a range from 1.2 bar to 3 bar, and the fluid conveying unit is configured to pressurize the fluid to a pressure of at least 500 bar. (Claim 7)
Vorm, directed to a chromatographic separation system {Vorm, Abstract}, teaches wherein the pre-filter pump is configured to pressurize the fluid at a lower pressure than the fluid conveying unit; (Claim 6) {[0014] re. pumps configured for flow rates of 1-50 bar entering into a holding loop (low pressure) and pumps configured for 1-3,000 bar for pumping fluid leading to a chromatography column} and comprising one of: the pre-filter pump is configured to pressurize the fluid to a pressure in a range from 1.2 bar to 3 bar; the pre-filter pump is configured to pressurize the fluid to a pressure in a range from 1.2 bar to 3 bar, and the fluid conveying unit is configured to pressurize the fluid to a pressure of at least 500 bar. (Claim 7) {[0014] re. pumps configured for flow rates of 1-50 bar entering into a holding loop (low pressure) and pumps configured for 1-3,000 bar for pumping fluid leading to a chromatography column}
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to modify Skudas with Vorm’s teachings wherein the pre-filter pump is configured to pressurize the fluid at a lower pressure than the fluid conveying unit; (Claim 6) and comprising one of: the pre-filter pump is configured to pressurize the fluid to a pressure in a range from 1.2 bar to 3 bar; the pre-filter pump is configured to pressurize the fluid to a pressure in a range from 1.2 bar to 3 bar, and the fluid conveying unit is configured to pressurize the fluid to a pressure of at least 500 bar (Claim 7) as Vorm, similar to Skudas, teaches a system including components for the delivery of a solution into a chromatography instrument. {Vorm, Abstract} One would be motivated to modify the pre-filter pump of Skudas to include the features of the pumps of Vorm as it is necessary to switch from low pressure to a high pressure position for chromatographic separation. {Vorm, [0014]}
Claim(s) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Skudas (US20130280788A1), as applied to the claims above, in view of Victor (US5862832A).
Regarding claim 14, Skudas teaches wherein: the supply path comprises a plurality of supply conduits configured to provide a plurality of different fluids, respectively; {[0025] re. lines for liquid between separation units and the solvent delivery system & [0101] re. two or more liquid streams coning from two or more reservoirs} the sterile filter is one of a plurality of sterile filters, {[0050] re. one or more sterile filters} the sterile filters respectively disposed in the supply conduits upstream of the fluid conveying unit and configured to respectively filter the different fluids. {Figure 15 re. sterile filter upstream of the chromatography/separation device of the taught invention}
This figure of Skudas is silent to a plurality of sterile filters, but given the Skudas teaches a plurality of conduit lines between the reservoirs and the separation systems, it is clear to one of ordinary skill in the art, that a sterile filter is deployed between each of the solvent lines when there are multiple.
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to include a sterile filter in each conduit line as some conduits may not be filtered, if a sterile filter was not placed within every conduit leading towards to chromatography separation system, which would lower the effectiveness of the delivery system.
Skudas further teaches a fluid combining unit configured to combine the fluid packages outputted from the proportioning unit to form the mobile phase; {[0050] re. in-line portion of the static mixers (wherein the line or pipe is the fluid combining unit)} and the fluid conveying unit is configured to receive and pressurize the mobile phase from the fluid combining unit and to convey the mobile phase to the sample separating device. {[0101] re. pump and reservoir for delivery of a liquid to separation system}
Skudas fails to teach the fluid supply device further comprises: a proportioning unit upstream of the fluid conveying unit and configured to proportion fluid packages of the different fluids, respectively.
Victor, drawn to a device for use within a chromatography conveying apparatus, teaches the fluid supply device further comprises: a proportioning unit upstream of the fluid conveying unit and configured to proportion fluid packages of the different fluids, respectively. {Column 3 lines 41-48 re. a gradient proportioning valve and from the reservoirs to a common outlet} Given this component is taught take liquid from the reservoir, it is clear to one of ordinary skill in the art, that this component would be as claimed "upstream of the fluid conveying unit" taught by Skudas.
It would be obvious to one of ordinary skill prior to the effective filing date of the claimed invention to add to Skudas’ flow path to include Victor’s teachings wherein the fluid supply device further comprises: a proportioning unit upstream of the fluid conveying unit and configured to proportion fluid packages of the different fluids, respectively as both. Doing so is beneficial as the proportioning unit is more conducive to use, and there is more accurate delivery of the respective proportions of components in a liquid composition. {Victor, Column 3 lines 19-24}
Regarding claim 15, Skudas teaches wherein: the proportioning unit comprises a plurality of fluid valves respectively communicating with the supply conduits; and each fluid valve is switchable between a first state at which the fluid valve enables a passing of a respective one of the fluid packages from the respective supply conduit to the fluid combining unit, and a second state at which the fluid valve prevents the passing of the respective fluid from the respective supply conduit to the fluid combining unit. {[0099] re. solvent selection valves where each is selectively chosen when it is in liquid communication with the reservoirs and the separation system}
Regarding claim 16, Skudas teaches a plurality of pre-filter pumps disposed in the respective supply conduits and configured to push the respective different fluids through the respective sterile filters and toward the proportioning unit. {[0101] re, the pumps of the reservoirs can be used to mix two or more liquid streams coming from two or more reservoirs (prior to the sterile filter)}
Regarding claim 17, Skudas teaches a plurality of buffer units {[0217] re. at least two buffer reservoirs} disposed in the respective supply conduits between the respective sterile filters and the proportioning unit, the buffer units configured to buffer the respective different fluids. {[0221] re. different buffers used during the process}
Regarding claim 18, Skudas teaches a mixing unit disposed between the fluid combining unit and the fluid conveying unit, the mixing unit configured to mix the fluid packages of the mobile phase. {[0191] re. static mixers & Figure 15 re. "Static Mixer for salt addition" (referring to the mixer itself)}
Regarding claim 19, Skudas teaches wherein the fluid combining unit and the mixing unit are disposed between the proportioning unit and the fluid conveying unit. {[0050] re. in-line (combining unit) and static mixers (mixing unit)}.
Skudas fails to teach wherein the fluid combining unit and the mixing unit are configured as an integrally formed fluid member.
The claimed fluid combining unit to be combined with the mixing unit would be obvious to one of ordinary skill in the art at the effective filing date of the invention. Regarding MPEP § 2144.04 (V) (B) “making integral”. Re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965). The court affirmed, "that the use of a one piece construction instead of the structure disclosed in [the prior art] (multiple pieces) would be merely a matter of obvious engineering choice."
Regarding claim 20, Skudas teaches a sample separating device, comprising: the fluid supply device of claim 1, wherein a fluidic sample is to be injected into the mobile phase; {[0082] re. solvent can used to describe elute (mobile phase) and [0025] re. solvent delivery system} and a sample separating unit configured to receive the mobile phase with the fluidic sample injected therein and to separate the fluidic sample. {[0025] re. separation unit}
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Gebauer (US20130112624A1), drawn to a solvent delivery system to a chromatography device including sterile filters, pumps, pressure differences, and other features of some of the dependent claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONNOR J ROTONDI whose telephone number is (571)272-2058. The examiner can normally be reached M-F 8:00am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Lebron can be reached at (571)272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CONNOR J ROTONDI/ Examiner, Art Unit 1773
/BENJAMIN L LEBRON/ Supervisory Patent Examiner, Art Unit 1773
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