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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
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 dosing filter as claimed in claim 1 must be shown or the feature canceled from the claims. 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 4 is objected to because of the following informalities: “comprises a fist liquid” in the first line of the claim should read “comprises a first liquid”. Appropriate correction is required.
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.
Claims 1-2, 4, 6-8, 10, 37-39,42, 45, and 47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Labib (US 6454871 B1).
Regarding claim 1, Labib teaches a method of cleaning a lumen (method of cleaning tubing surfaces, abstract) comprising: flowing a first fluid comprising a cleaning agent to a chamber (suitable liquid including one or more cleaning agents is used to create flow along a surface, paragraph [0018]), wherein flowing the first fluid comprising the cleaning agent to the chamber creates a pressure differential across a filter fluidly coupled to the chamber (in the case of membranes, sequencing of pressure differences across the membrane, paragraph [0018]); reaching a threshold by the pressure differential, thereby triggering the flowing of the first fluid comprising the cleaning agent to the chamber to stop (pulsating gas flow can be turned on and off completely, paragraph [0062]); and flowing a second fluid through the chamber to convey the cleaning agent through a lumen, thereby cleaning the lumen (pressure applied in the same direction as normal operation of filter to allow solution to reach deeper into pores then followed by application of two-phase flow to remove newly-dislodged residue, paragraph [0147]).
Regarding claim 2, Labib teaches wherein the first fluid comprises a first gas selected from the group consisting of air, nitrogen, argon, or carbon dioxide (gas is generally air, paragraph [0037], and a useful gas is carbon dioxide, paragraph [0044]).
Regarding claim 4, Labib teaches wherein the first fluid comprises a first liquid (mixed phase cleaning mixture of an aqueous solution, abstract), and the cleaning agent is substantially insoluble in the first liquid (solid particles can be added to the cleaning solution and can be insoluble in water, paragraph [0093]), and wherein the first liquid comprises at least one of aqueous liquid, an alcohol, a hydrocarbon, or carbon dioxide (liquid cleaning solution is most commonly an aqueous solution, paragraph [0037]).
Regarding claim 6, Labib teaches wherein a cross-sectional area of the filter is perpendicular to a direction of the flowing first fluid (a velocity component perpendicular to the wall which directs the drops into the wall, paragraph [0059], and applications include microfiltration and ultrafiltration wherein the wall of the fluid passageway is a permeable membrane, paragraph [0013]).
Regarding claim 7, Labib teaches wherein a cross-sectional area of the filter is parallel toa direction of the flowing first fluid (Figure 8 feed solution “850” flows parallel to rectangular membrane sheets “810” and “812” and porous structural layer “820”).
Regarding claim 8, Labib teaches wherein the second fluid comprises a second gas selected from the group of air, nitrogen, argon, or carbon dioxide (gas is generally air, paragraph [0037], and a useful gas is carbon dioxide, paragraph [0044]).
Regarding claim 10, Labib teaches wherein the second fluid comprises a second liquid selected from the group consisting of an aqueous liquid, an alcohol, a hydrocarbon, or carbon dioxide (liquid cleaning solution is most commonly an aqueous solution, paragraph [0037]).
Regarding claim 37, Labib teaches mixing a first portion of the cleaning agent and a first portion of water to form an aggregate (adding a cleaning agent to a pure liquid such as water, paragraph [0077]); injecting the aggregate into the lumen of the medical device (cleaning solution pumped into dialysate side of hemodialyzer, paragraph [00156]); and injecting a quantity of air into the lumen of the medical device after the aggregate (dry air suppled to interior of the hollow fibers to produce back flushing and tow-phase gas-liquid flow, paragraph [0156]).
Regarding claim 38, Labib teaches wherein a proportion of the first portion of cleaning agent to the first portion of water is about 0.5% to about 5% or about 1% to about 3% (surfactant concentration of sodium dodecyl sulfate was 1%, paragraph [0143]).
Regarding claim 39, Labib teaches wherein the cleaning agent comprises sodium bicarbonate (example of suitable solid particles include sodium bicarbonate, paragraph [0093]).
Regarding claim 42, Labib teaches wherein the first portion of cleaning agent further comprises air (mixed phase cleaning mixture of a flow of gas, abstract, and gas is generally air, paragraph [0037]).
Regarding claim 45, Labib teaches wherein the mixing comprises mixing a first portion of surfactant and the first portion of cleaning agent and the first portion of water to form the aggregate (cleaning agent solution contained sodium carbonate together with a surfactant, paragraph [0137]).
Regarding claim 47, Labib teaches wherein a flow of the aggregate is turbulent (main flow of the gas is turbulent and enhances the impact of the droplets against the wall by means of the random turbulent fluctuations of local velocity, paragraph [0059]).
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.
Claims 40-41 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Labib.
Regarding claim 40, while Labib does not explicitly teach wherein the first portion of cleaning agent is about 1g to about 10 g or about 4 g to about 6 g, generally the differences in concentration will not support patentability. Labib teaches the cleaning agent is commonly a surfactant (paragraph [0018]) and that the concentration of the surfactant can be changed to result in the ideal liquid surface tension for the disinfection application (paragraph [0053]). Therefore, it would have been obvious to one of ordinary skill in the art to optimize the surfactant content to be about 1g to about 10 g or about 4 g to about 6 g to result in the appropriate surface tension through routine optimization (See MPEP 2144.05 II (A)).
Regarding claim 41, while Labib does not explicitly teach wherein the first portion of water is about 50 g to about 500 g or about 100 g to about 400 g, generally the differences in concentration will not support patentability. Labib teaches that the ratio of the water to the surfactant can be changed to result in the ideal liquid surface tension for the disinfection application (paragraph [0053]). Therefore, it would have been obvious to one of ordinary skill in the art to optimize the water content to be about 50g to about 500 g or about 100 g to about 400 g to result in the appropriate surface tension through routine optimization (See MPEP 2144.05 II (A)).
Regarding claim 46, while Labib does not explicitly teach wherein the first portion of surfactant is about 0.1 g to about 3 g or about 0.5 g to about 1.5 g, generally the differences in concentration will not support patentability. Labib teaches that the concentration of the surfactant can be changed to result in the ideal liquid surface tension for the disinfection application (paragraph [0053]). Therefore, it would have been obvious to one of ordinary skill in the art to optimize the surfactant content to be about 0.1 g to about 3 g or about 0.5 g to about 1.5 g to result in the appropriate surface tension through routine optimization (See MPEP 2144.05 II (A)).
Claims 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Labib in view of Yang (US 20200000949 A1).
Regarding claim 43, Labib teaches all aspects of the current invention except a step of heating the water to a temperature before the mixing. However, Yang teaches a step of heating the water to a temperature before the mixing (water temperature is controlled by controlling a mix of unheated and heated water to maintain a temperature of about 35°C then the system adds detergent to the water, paragraph [0050]).
Labib and Yang are considered analogous to the current invention because all are in the field of lumen cleaning methods. Therefore, it would have been obvious to one of ordinary skill in the art to combine the cleaning method taught by Labib with the water heating step taught by Yang because Yang teaches that the addition of an inline water heater advantageously allows for the liquid to be heated to the optimum temperatures for cleaning and disinfecting (paragraph [0033]).
Regarding claim 44, the combination of Labib and Yang teaches all aspects of the current invention as discussed above including wherein the temperature is about 15°C to about 25°C or about 25°C to about 40°C (maintain a temperature of about 35°C, paragraph [0050], Yang).
Allowable Subject Matter
Claims 34-36 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: the closest prior art is Labib as identified above. However, Labib does not teach a delivery of a cleaning agent dose to an eductor and the use of a filter to achieve the specific dosage.
The prior art as a whole does not teach the claimed invention within the claim environment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAYLA ROSE SARANTAKOS whose telephone number is (703)756-5524. The examiner can normally be reached Mon-Fri 7:00-4:00.
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/K.R.S./Examiner, Art Unit 1799
/DONALD R SPAMER/Primary Examiner, Art Unit 1799
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