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 .
Election/Restrictions
Applicant’s election without traverse of claims 11-16 in the reply filed on 04/30/2026 is acknowledged.
Priority
Acknowledgment is made of the applicant's priority to the US provisional application 63/436,031.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 05/07/2024 has/have been considered by the examiner.
Claim Interpretation
Claim 1 states, “for a medical device”. MPEP 2111.02(II) states, “the claim preamble must be read in the context of the entire claim. If the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of the claimed invention’s limitations, then the preamble is not considered a limitation and is no significance to claim construction. Therefore, the limitation of “for a medical device” in the preamble of claim 1 is not given patentable weight.
Claims 1, 5, 7, and 10 state, “wherein responsive to a change in the first pressure of the fluid in the reservoir”, and will be interpreted as a manner of operation.
Claim 2 states, “fluid” and “water”, which are articles worked upon. Said limitations do not differentiate apparatus claims from prior art. See MPEP 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states 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.
Claim 2 states, “the medical device”. This feature has not been positively recited as part of the system, and is still recited as an intended use of the system. As stated in the MPEP 2115, a claim is only limited by positively recited elements.
Claims 3-4 state, “wherein the change in the first pressure of the fluid in the reservoir”, and will be interpreted as a manner of operation.
Claim 8 states, “wherein the first pressure and the second pressure are the same”, and will be interpreted as a manner of operation.
Claim 9 states, “wherein the first pressure is between 62.5 pounds per square inch and 67.5 pounds per square inch, and the second pressure is less than the first pressure”, and will be interpreted as a manner of operation.
Claim 17 states, “wherein responsive to the reservoir gauge determining the pressure of the fluid in the reservoir”, and will be interpreted as a manner of operation.
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 1-10 and 17-20 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 claims 1, 5, 7, 10; these claims state, “wherein responsive to a change in the first pressure of the fluid in the reservoir” and regarding claim 17; the claim states, “wherein responsiveness to the reservoir gauge determining the pressure of the fluid in the reservoir”. It is not clear if the claim limitation is intended to be a functional limitation of an unclaimed structure, e.g. a remote computing device such as described in paragraph 40 of the instant specification, or if the claimed limitation is directed to a manner of operation. Applicant is reminded that a manner of operation has no patentable weight in a system or apparatus claim. See MPEP 2114(II). Also note MPEP 2173.05(g), “the use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite” because of the lack of structure associated with that recitation. For the purpose of examination, the phrases of claims 1, 5, 7, 10, and 17 are interpreted as a manner of operation. Claims 2-4, 6, 8-9, and 18-20 are rejected due to their dependency on the mentioned claims above.
Regarding claims 1-4, 17, and 19; these claims have redundant antecedent basis. Claim 1 and 17 provides antecedent basis for “a fluid” in their preambles, however in multiple locations after the preambles of claim 1 or 17, the applicant uses the term “fluid” (e.g., “receive fluid”, “house fluid”, “a fluid” in the preambles of claims 2-4, etc.). It is unclear whether each mention of fluid is intended to refer to the same basis of fluid, as claimed in the preambles of the independent claims, or if they are intended to refer to different fluids. The examiner believes the applicant intended for the fluid in the preambles of claim 1 or claim 17, to refer to the continuous mentions of fluid, as mentioned above, and will interpreted as such. Appropriate correction is required. The examiner suggest the applicant provide “the” before fluid in most cases to resolve this objection, unless the applicant intended a different fluid, to which then the examiner suggests clarity within the claims for that distinction of fluids.
Regarding claims 2-10, claims 2-4 restate the preamble of claim 1, while claims 5-10 restate “system” of claim 1 only in their respective preambles. It is not clear if the applicant intends the different restatements to have different meanings. It is requested the applicant amends for consistency in their preamble restatements.
Regarding claims 3-4 and 8-9, no additional structure is recited. It is not clear if the claim limitation is to be a functional limitation of an unclaimed structure, or if the claim limitation is directed to a manner of operation. Applicant is reminded that a manner of operation has no patentable weight in a system or apparatus claim. See MPEP 2114(II). Due to the lack of structure, the limitation is interpreted as a manner of operation.
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) 1-10 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulme (US20210024381A1) in view of Fu (CN106219811A). *Note all teachings from Fu are based on the attached, English, machine-translated version.
Regarding claim 1, Hulme discloses a system for treatment of a fluid for a medical device, {abstract} the system comprising:
a pump fluidly coupled with an inlet tube, the pump configured to receive a fluid from the inlet tube and pump the fluid; {[0021] regarding inlet 117 and pump 120}
a purification device fluidly coupled with the pump, the purification device configured to receive fluid from the pump and treat the fluid; {[0021] regarding membrane 140 (purification device) and pump 120}
a reservoir fluidly coupled with the purification device, {[0016] regarding storage tank 180 (reservoir) and RO membrane unit 140} the reservoir configured to house fluid in the reservoir at a first pressure; {[0018] regarding where water pressure in storage tank 180 can drop, showing the capability of holding pressure}
a reservoir gauge coupled with the reservoir, the reservoir gauge configured to determine pressure of the fluid in the reservoir; {[0021] regarding controller module 160 measuring pressure in storage tank 180}
an outlet tube fluidly coupled with the reservoir, the outlet tube configured to facilitate a first flow of fluid from the reservoir. {[0021] regarding outlet 150 and storage tank 180}
Regarding claim 17, Hulme discloses a system {Abstract}, the system comprising:
an inlet valve, the inlet valve configured to receive a fluid and control a first flow of fluid; {[0020] regarding pressure regulator 114 coupled with solenoid valve SV1 (inlet valve)}
a pump fluidly coupled with the inlet valve, the pump configured to receive the first flow of fluid from the inlet valve and pump the fluid; {[0020-0021] regarding pressure regulator 114, inlet 117, and pump 120}
a purification device fluidly coupled with the pump, the purification device configured to receive fluid from the pump and treat the fluid; {[0021] regarding membrane 140 (purification device) and pump 120}
a reservoir fluidly coupled with the purification device, {[0016] regarding storage tank 180 (reservoir) and RO membrane unit 140} the reservoir configured to house fluid in the reservoir at a first pressure; {[0018] regarding where water pressure in storage tank 180 can drop, showing the capability of holding pressure}
a reservoir gauge coupled with the reservoir, the reservoir gauge configured to determine pressure of the fluid in the reservoir; {[0021] regarding controller module 160 measuring pressure in storage tank 180}
wherein responsive to the reservoir gauge determining the pressure of the fluid in the reservoir is the first pressure, {Note manner of operation has no patentable weight. The structure of Hulme coupled with their controller module [0008] suggest the capability of this function} the inlet valve is configured to transition to a closed state and restrict the first flow of fluid to the pump. {[0020] regarding pressure regulator 114 and solenoid valve SV1}
Regarding claim 1, Hulme fails to disclose a relief valve fluidly coupled with the reservoir, the relief valve configured to control a second flow of fluid from the reservoir, wherein responsive to a change in the first pressure of the fluid in the reservoir, the relief valve is configured to modify the second flow of fluid from the reservoir.
Regarding claim 5, Hulme fails to disclose wherein responsive to the change in the first pressure of the fluid in the reservoir, the relief valve is configured to decrease the second flow of fluid from the reservoir.
Regarding claim 7, Hulme fails to disclose wherein responsive to the change in the first pressure of the fluid in the reservoir, the relief valve is configured to modify the second flow of fluid from the reservoir to maintain a second pressure of the fluid in the reservoir.
Regarding claim 10, Hulme fails to disclose wherein responsive to the change in the pressure of the fluid in the reservoir, the relief valve is configured to modify the second flow of fluid from the reservoir such that the change in the first pressure does not exceed a predetermined threshold.
Regarding claim 17, Hulme fails to disclose a relief valve fluidly coupled with the reservoir, the relief valve configured to control a second flow of fluid from the reservoir.
Regarding claim 1, Fu teaches a relief valve fluidly coupled with the reservoir, the relief valve configured to control a second flow of fluid from the reservoir, {Bottom page 2 and top page 3 regarding the relief valve coupled with the pressure limiting valve} wherein responsive to a change in the first pressure of the fluid in the reservoir, the relief valve is configured to modify the second flow of fluid from the reservoir. {Note manner of operation has no patentable weight. The relief and pressure limiting valves (Bottom page 2 - top page 3) suggest the capability of this function}
Regarding claim 5, Fu suggests wherein responsive to the change in the first pressure of the fluid in the reservoir, the relief valve is configured to decrease the second flow of fluid from the reservoir. {Note manner of operation has no patentable weight. The relief and pressure limiting valves (Bottom page 2 - top page 3) suggest the capability of this function}
Regarding claim 7, Fu suggests wherein responsive to the change in the first pressure of the fluid in the reservoir, the relief valve is configured to modify the second flow of fluid from the reservoir to maintain a second pressure of the fluid in the reservoir. {Note manner of operation has no patentable weight. The relief and pressure limiting valves (Bottom page 2 - top page 3) suggest the capability of this function}
Regarding claim 10, Fu suggests wherein responsive to the change in the pressure of the fluid in the reservoir, the relief valve is configured to modify the second flow of fluid from the reservoir such that the change in the first pressure does not exceed a predetermined threshold. {Note manner of operation has no patentable weight. The relief and pressure limiting valves (Bottom page 2 - top page 3) suggest the capability of this function}
Regarding claim 17, Fu teaches a relief valve fluidly coupled with the reservoir, the relief valve configured to control a second flow of fluid from the reservoir. {Bottom page 2 and top page 3 regarding the relief valve coupled with the pressure limiting valve}
Regarding claims 1, 5, 7, 10, and 17; it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the invention of Hulme with the relief valve assembly of Fu because both inventions are water treatment devices meant to treat fluid, then dispense said fluid to a dialysis machine. One of ordinary skill in the art prior to the effective filing date of the claimed invention would be motivated to combine to combine the relief valve assembly of Fu to Hulme because, as taught by Fu, setting the relief valve allows for specific pressure output parameters, creating a more comfortable experience for the user of the device. {Fu, Bottom page 3} Given Fu already teaches the relief valve and pressure limiting valve can be connected to a controller {Fu, Top page 3}, it is clear of the compatibility to a controller that had already been disclosed in Hulme.
Regarding claim 2, Hulme discloses the system is a water pre-treatment system and the medical device is a dialysis machine. {[0015] regarding water supply system 100 and hemodialysis applications}
Regarding claim 3, Hulme suggests wherein the change in the first pressure of the fluid in the reservoir is responsive to an increase in the first flow of fluid from the reservoir. {Note manner of operation has no patentable weight. The structure of Hulme coupled with their controller module [0008] suggest the capability of this function}
Regarding claim 4, Hulme suggests wherein the change in the first pressure of the fluid in the reservoir is a decrease in the first pressure of the fluid. {Note manner of operation has no patentable weight. The structure of Hulme coupled with their controller module [0008] suggest the capability of this function}
Regarding claim 6, Hulme discloses the relief valve is configured to decrease the second flow of fluid from the reservoir by an amount equal to an amount of the first flow of fluid from the reservoir. {[0008] regarding the solenoid valves and changing the pressure in the pump flow rates}
Regarding claim 8, Hulme suggests wherein the first pressure and the second pressure are the same. {Note manner of operation has no patentable weight. The structure of Hulme coupled with their controller module [0008] suggest the capability of this function}
Regarding claim 9, Hulme suggests wherein the first pressure is between 62.5 pounds per square inch and 67.5 pounds per square inch, and the second pressure is less than the first pressure. {Note manner of operation has no patentable weight. The structure of Hulme coupled with their controller module [0008] suggest the capability of this function}
Regarding claim 18, Hulme discloses the pump is configured to pump the fluid at a constant flow rate. {[0021] regarding pump 120 and sending constant water supply to an external device}
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hulme (US20210024381A1) and Fu (CN106219811A), in view of Leuhmann (US20030034305A1). *Note all teachings from Fu are based on the attached, English, machine-translated version.
Regarding claim 19, the combination of Hulme and Fu fail to disclose or teach a flowmeter communicably coupled with the pump, wherein the flowmeter is configured to determine a flow rate of fluid from the pump.
Regarding claim 19, Leuhmann teaches a flowmeter communicably coupled with the pump, wherein the flowmeter is configured to determine a flow rate of fluid from the pump. {[0072] regarding pumps and flow meters}
Regarding claim 19, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Hulme and Fu with the addition of flow meters of Leuhmann because, similarly to the combined invention, Leuhmann is a water treatment apparatus for purifying and dispensing fluid into a dialysis or other medical device. One of ordinary skill in the art prior to the effective filing date of the claimed invention would be motivated to combine the flow meters of Leuhmann as flow monitoring automation is advantageous in a device that requires specific flow and pressure rates, such as medical equipment. {Leuhmann, [0073]}
Regarding claim 20, the combination of Hulme and Fu fail to disclose or teach a feedback tube fluidly coupled with the relief valve and an inlet tube in communication with the pump, wherein the feedback tube is configured to facilitate movement of fluid from the relief valve to the pump.
Regarding claim 20, Leuhmann teaches a feedback tube fluidly coupled with the relief valve and an inlet tube in communication with the pump, wherein the feedback tube is configured to facilitate movement of fluid from the relief valve to the pump. {[0030] regarding shunt feedback line 40 (feedback tube) and Fig. 3}
Regarding claim 20, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system of Hulme and Fu with feedback tube of Leuhmann as similarly stated above, these invention appear in a specific species of analogous art. One of ordinary skill in the art prior to the effective filing date of the claimed invention would be motivated to add the feedback tube to the combined invention of Hulme and Fu as the feedback tube allows for in-line adjustments after the pump has sent the fluid to the medical device, but before the fluid has reached the device, creating a quality control loop for potential contamination, parameter changes, or other factors that can influence the medical equipment.
Conclusion
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
/JOSEPH W DRODGE/Primary Examiner, Art Unit 1773
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