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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/27/2024 and 10/23/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in the following figures, two reference characters have both been used to designate a single part, presented in the format of A(X), with A being a first reference number and X being a second reference number. The examiner finds this confusing as it appears to identify a single part with two different reference numbers. The examiner suggests selecting a single reference number to identify a single part.
FIG. 3: 100(200)
FIG. 11: 1a(1) and 1b(1)
FIG. 12: 81(8) and 82(8)
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because in FIG. 1, 10, 11, 12, 14, notification unit 90 uses two reference characters to designate a single part, presented as “91, 95”. The examiner finds this confusing as it appears to identify a single part with two different reference numbers. The examiner suggests selecting a single reference number to identify a single part.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: A, S.
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 mentioned in the description: antenna 19.
The drawings are objected to because in FIG. 1, FIG. 10, FIG. 11, and FIG. 14, the configurations of an infusion solution oxygenation device do not disclose where on the device the container pressure sensing unit 31, oxygen concentration sensing unit 32, temperature sensing unit 33, remaining amount sensing unit 34, and biological information acquisition unit 35 are located. The examiner acknowledges units 31-35 are included in other figures. However, the examiner believes it would be helpful in understanding the entirety of the invention if these units 31-35 were labeled on the above listed figures. It would also suffice to label only the control unit C on the above listed figures, as the examiner interprets the units 31-35 to be parts of the control unit C.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters in the description in compliance with 37 CFR 1.121(b) 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 of the following informalities: Beginning in paragraph [0060] and continuing on throughout the specification, the applicant uses the abbreviation “CPU”. Acronyms and abbreviations should be defined the first time they are used to remove ambiguity as to what the applicant means.
Appropriate correction is required.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 is directed towards components of the catheter connection portion. However, the examiner interprets the catheter connection portion, previously a catheter connection portion in claim 1, as a singular part. The components of claim 2, an air supply unit and an exhaust unit, separate the catheter connection portion into two separate parts, as can be seen in FIG. 11. By separating the catheter connection portion into two separate parts, claim 2 no longer aligns with the singular part of claim 1. The examiner suggests making a catheter connection portion plural in claim 1 to reflect the multiple parts as claimed in claim 2, or removing one of the claim limitations of claim 2. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: The limitation of “an air supply unit configured to supply the oxygen-containing gas into the infusion solution container” in claim 2 presents almost identical wording to the limitation of “a gas supply unit configured to supply the oxygen-containing gas to the catheter connection portion” in claim 1. It is unclear when reading the claim whether the air supply unit has means of providing its own oxygen-containing gas separate from that of the gas supply unit, or if the air supply unit is simply a part with a lumen, allowing for the passage of the oxygen-containing gas from the gas supply unit. The examiner acknowledges the applicant has addressed this concern in paragraph [0118] of the specification, stating “the air supply unit 1a is supplied with the oxygen-containing gas from the gas supply unit 21”. The examiner suggests adding specificity to the language claim 2 to clearly state what the applicant intends to claim. The applicant may, for example, change the language to read “an air supply unit configured to supply the oxygen-containing gas from the gas supply unit into the infusion solution container”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: The fifth and sixth lines of the claim states “a brain/tissue oxygen saturation”. However, in the third and fourth lines of the same claim, the claim states “a tissue oxygen saturation”. The examiner interprets “brain/tissue” as meaning both brain and tissue, or one or the other, brain or tissue. The examiner suggests modifying “a brain/tissue oxygen saturation” to be “a brain oxygen saturation” to avoid claiming the same limitation twice. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: In the sixth line of the claim, the claim states “an internal pressure of the infusion solution container”. However, claim 1 had already stated “an internal pressure of the infusion solution container”. It is unclear to the examiner if “an internal pressure” of claim 10 is the same internal pressure as claim 1. The examiner suggests if the internal pressures are the same, modifying “an” to “the” in claim 10. If the internal pressures are different, the examiner suggests adding more context to claim 10 to more clearly state a difference. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: The limitation of “supplying the oxygen-containing gas into the infusion solution container with an air supply unit” in claim 15 presents similar wording to the limitation of “supplying an oxygen-containing gas to an infusion solution in an infusion solution container via a catheter, the catheter being connected to a catheter connection portion; supplying the oxygen-containing gas to the catheter connection portion via a gas supply unit” in claim 14. It is unclear when reading the claim whether the air supply unit has means of providing its own oxygen-containing gas separate from that of the gas supply unit, or if the air supply unit is simply a part with a lumen, allowing for the passage of the oxygen-containing gas from the gas supply unit. The examiner acknowledges the applicant has addressed this concern in paragraph [0118] of the specification, stating “the air supply unit 1a is supplied with the oxygen-containing gas from the gas supply unit 21”. The examiner suggests adding specificity to the language claim 15 to clearly state what the applicant intends to claim. The applicant may, for example, change the language to read “supplying the oxygen-containing gas from the gas supply unit into the infusion solution container with an air supply unit”. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: The fifth line of the claim states “a brain/tissue oxygen saturation”. However, in the third line of the same claim, the claim states “a tissue oxygen saturation”. The examiner interprets “brain/tissue” as meaning both brain and tissue, or one or the other, brain or tissue. The examiner suggests modifying “a brain/tissue oxygen saturation” to be “a brain oxygen saturation” to avoid claiming the same limitation twice. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: In the first line of the claim, the claim states “one or more of”. This language is not exact in expressing the desired limitations of the claim, as it is interpreted as meaning only one limitation is needed to be met, but there is a possibility that more could need to be met as well. The examiner suggests removing this language and reviewing the limitations of the claim, in order to be clear as to what limitations the applicant distinctly wants to claim. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: In the fifteenth and sixteenth lines of the claim, the claim states “sensing the oxygen concentration of the infusion solution with the oxygen concentration sensing unit”. However, previously in the ninth and tenth lines of the claim, the claim almost identically states “sensing a temperature of the infusion solution with a temperature sensing unit”. Because the claim states in the first line “one or more of”, the examiner interprets that these two claim limitations have the possibility of being claimed together, which would be considered duplicate claims and improper. The examiner suggests removing one of the instances of the limitation, or rewriting the claim to make it clearer that under one circumstance, the oxygen concentration may be used for temperature adjustment, and under another circumstance the oxygen concentration may be used for pressure adjustment. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: In the seventeenth an eighteenth lines of the claim, the claim states “an internal pressure of the infusion solution container”. However, claim 14 had already stated “an internal pressure of the infusion solution container”. It is unclear to the examiner if “an internal pressure” of claim 20 is the same internal pressure as claim 14. The examiner suggests if the internal pressures are the same, modifying “an” to “the” in claim 20. If the internal pressures are different, the examiner suggests adding more context to claim 20 to more clearly state a difference. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are:
The recitation, in claim 1, of "a gas supply unit configured to supply the oxygen-containing gas to the catheter connection portion" has been interpreted as structurally a supply control mechanism that supplies the oxygen-containing gas to the catheter and controls the supply of the oxygen-containing gas. Examples may include an aperture adjusting valve or an automatic valve including an actuator [0064].
The recitation, in claim 1 and claim 12, of “a container pressure sensing unit configured to sense an internal pressure of the infusion solution container” has been interpreted as structurally a sensor that senses pressure [0079].
The recitation, in claim 2, of “an air supply unit configured to supply the oxygen-containing gas into the infusion solution container” has been interpreted as structurally a component that allows for gas passage [0118].
The recitation, in claim 2, of “an exhaust unit configured to exhaust gas from the inside of the infusion solution container” has been interpreted as structurally a component that can discharge gas from an exhaust pipe to the outside via an exhaust valve [0119].
The recitation, in claim 3, claim 9, and claim 10, of “an oxygen concentration sensing unit configured to sense an oxygen concentration of the infusion solution” has been interpreted as structurally a sensor that senses the oxygen concentration of an infusion solution, a circuit that senses the oxygen concentration of the infusion solution on the basis of a signal output from a sensor, or a functional unit implemented by execution of a program by a CPU or the like [0080].
The recitation, in claim 4, of “a pressure adjustment unit configured to adjust an internal pressure of the infusion solution container” has been interpreted as structurally a pressure adjusting mechanism that adjusts the internal pressure of the infusion solution container. Examples may include a pressure adjustment valve, such as a pressure increasing valve or a pressure reducing valve [0065].
The recitation, in claim 5, of “a biological information acquisition unit configured to acquire biological information of a patient” has been interpreted as structurally a sensor that acquires biological information, such as any medical device that acquires the biological information of the patient [0086].
The recitation, in claim 7, of “ a remaining amount sensing unit configured to sense a remaining amount of the infusion solution in the infusion solution container” has been interpreted as structurally a sensor that senses the remaining amount of an infusion solution in an infusion solution container, a circuit that senses the temperature of an infusion solution on the basis of a signal output from the sensor, or a functional unit implemented by execution of a program by a CPU or the like [0084].
The recitation, in claim 8 and claim 9, of “a temperature sensing unit configured to sense a temperature of the infusion solution” has been interpreted as structurally a sensor that senses the temperature of an infusion solution, a circuit that senses the temperature of an infusion solution on the basis of a signal output from the sensor, or a functional unit implemented by execution of a program by a CPU or the like [0082].
The recitation, in claim 9, of “a temperature adjustment signal transmission unit configured to transmit a temperature adjustment signal for adjusting the temperature of the infusion solution” has been interpreted as structurally a functional unit realized by executing a program by an electric circuit, a CPU, or the like that transmits a signal [0134].
The recitation, in claim 10, of “pressure adjustment signal transmission unit configured to transmit a pressure adjustment signal for adjusting an internal pressure of the infusion solution container” has been interpreted as structurally a functional unit realized by executing a program by an electric circuit, a CPU, or the like that transmits a pressure adjusting signal [0143].
The recitation, in claim 12, of “a gas supply unit configured to supply the oxygen-containing gas to the catheter” has been interpreted as structurally a supply control mechanism that supplies the oxygen-containing gas to the catheter and controls the supply of the oxygen-containing gas. Examples may include an aperture adjusting valve or an automatic valve including an actuator [0064].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 2, 14, and 15 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.
Claim 2 recites the limitation "gas" in the fifth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, in the first line of the claim, the claim states “A method for supplying to an infusion solution”. The claim fails to particularly point out and distinctly claim what is completing the action of “supplying”, as well as what is being supplied, thereby rendering the claim indefinite. It is unclear to one having ordinary skill in the art what the applicant intends to claim by the current language. The examiner suggests modifying the current language to add specificity as to what is completing the action of “supplying”, as well as what is being supplied. For the purposes of examination, the examiner will interpret the claim to mean an infusion solution oxygenation device is supplying oxygen-containing gas to an infusion solution.
Claim 15 recites the limitation "gas" in the fourth line of the claim. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 2, 8, 12, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Grady et al. (United States Patent Application Publication No. US 2013/0230602 A1; herein, Grady), and further in view of Loser et al. (United States Patent Application Publication No. US 2002/0069876 A1; herein, Loser).
Regarding claim 1, Grady discloses an infusion solution oxygenation device (Annotated on Figure 2 below) comprising: a catheter connection portion (Annotated on Figure 2 below) connected to a catheter (Annotated Figure 2, catheter connection portion connects to gas conducting tubing 26), the catheter configured to supply an oxygen-containing gas to an infusion solution in an infusion solution container ([0079], "the gas travels from the gas blender 20 and flowmeter 24, through gas tubing 26 and 53, and into the gas-liquid contact device 40"; [0074], "oxygen is introduced into the system through the blender 20". At this point, there is already liquid in the gas-liquid contact device 40.); a gas supply unit (gas blender 20) configured to supply the oxygen-containing gas to the catheter connection portion ([0074], "oxygen is introduced into the system through the blender 20").
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Grady does not disclose a container pressure sensing unit configured to sense an internal pressure of the infusion solution container; and wherein the gas supply unit is configured to control supply of the oxygen-containing gas based on the internal pressure sensed by the container pressure sensing unit.
However, Loser teaches a container pressure sensing unit (pressure sensor 25) configured to sense an internal pressure of the infusion solution container ([0023], "A pressure sensor 25 is arranged between the pressurized gas stub and the pressurized gas reservoir 21 and detects the internal pressure within the supply vessel 1."); and wherein the gas supply unit is configured to control supply of the oxygen-containing gas based on the internal pressure sensed by the container pressure sensing unit ([0023], Measured values of the sensor 25 are considered by a control unit 22 for metering. Examiner interprets how the control unit 22 intakes information from the sensor 25 for metering of liquid to be the same process as the gas supply unit intaking an internal pressure value to control the amount of gas provided.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Grady to include a container pressure sensing unit able to sense internal pressure as taught by Loser in order to meter the quantity of the infused product ([0023]), in this case oxygen-containing gas. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the internal pressure sensed by the container pressure sensing unit as taught by Loser in order that the gas supply unit have the ability to process measured valves sent by the container pressure sensing unit and output controls for the metering of the infused product ([0022]), in this case oxygen-containing gas.
Regarding claim 2, in the modified device of Grady, Grady discloses an air supply unit configured to supply the oxygen-containing gas into the infusion solution container (Annotated Figure 2 above depicts the connection from blender 20, through catheter connection portion, to gas-liquid contact device 40. It would be commonly understood that the catheter connection portion would contain an air supply unit as gas is supplied from blender 20, and the catheter connection portion is able to supply that gas to gas conducting tubing 26.); and an exhaust unit configured to exhaust gas from the inside of the infusion solution container ([0067], "The adjustable stopcock valve outlet and filter 37 may operate as a vent"; [0083], gas is able to exit the gas-liquid contact device by means of the adjustable stopcock valve outlet and filter 37).
Regarding claim 8, in the modified device of Grady, Grady does not disclose a temperature sensing unit configured to sense a temperature of the infusion solution; and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the temperature sensed by the temperature sensing unit.
However, Loser teaches a temperature sensing unit (temperature sensor 24) configured to sense a temperature of the infusion solution ([0023], "the temperature of the anesthetic 6 is additionally detected with a temperature sensor 24"); and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the temperature sensed by the temperature sensing unit ([0023], Measured values of the sensor 24 are considered by a control unit 22 for metering. Examiner interprets how the control unit 22 intakes information from the sensor 24 for metering of liquid to be the same process as the gas supply unit intaking a temperature value to control the amount of gas provided.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include a temperature sensing unit able to sense a temperature of the infusion solution as taught by Loser in order to meter the quantity of the infused product ([0023]), in this case oxygen-containing gas. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the temperature sensed by the temperature sensing unit as taught by Loser in order that the gas supply unit have the ability to process measured valves sent by the temperature sensing unit and output controls for the metering of the infused product ([0022]), in this case oxygen-containing gas.
Regarding claim 12, Grady discloses an infusion solution oxygenation system (Figure 2 displays the entire system) comprising: a catheter (gas conducting tubing 26) configured to supply an oxygen-containing gas to an infusion solution in an infusion solution container ([0079], "the gas travels from the gas blender 20 and flowmeter 24, through gas tubing 26 and 53, and into the gas-liquid contact device 40"; [0074], "oxygen is introduced into the system through the blender 20". At this point, there is already liquid in the gas-liquid contact device 40.); a gas supply unit (gas blender 20) configured to supply the oxygen-containing gas to the catheter ([0074], "oxygen is introduced into the system through the blender 20").
Grady does not disclose a container pressure sensing unit configured to sense an internal pressure of the infusion solution container; and wherein the gas supply unit is configured to control supply of the oxygen-containing gas based on the internal pressure sensed by the container pressure sensing unit.
However, Loser teaches a container pressure sensing unit (pressure sensor 25) configured to sense an internal pressure of the infusion solution container ([0023], "A pressure sensor 25 is arranged between the pressurized gas stub and the pressurized gas reservoir 21 and detects the internal pressure within the supply vessel 1."); and wherein the gas supply unit is configured to control supply of the oxygen-containing gas based on the internal pressure sensed by the container pressure sensing unit ([0023], Measured values of the sensor 25 are considered by a control unit 22 for metering. Examiner interprets how the control unit 22 intakes information from the sensor 25 for metering of liquid to be the same process as the gas supply unit intaking an internal pressure value to control the amount of gas provided.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Grady to include a container pressure sensing unit able to sense internal pressure as taught by Loser in order to meter the quantity of the infused product ([0023]), in this case oxygen-containing gas. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the internal pressure sensed by the container pressure sensing unit as taught by Loser in order that the gas supply unit have the ability to process measured valves sent by the container pressure sensing unit and output controls for the metering of the infused product ([0022]), in this case oxygen-containing gas.
Regarding claim 14, Grady discloses a method for supplying to an infusion solution ([0031], "methods include...solvation of the gas into the liquid"; [0079], Disclosure teaches a method of moving gas from a blender 20 to a gas-liquid contact device 40), the method comprising: supplying an oxygen-containing gas to an infusion solution in an infusion solution container via a catheter ([0079], "the gas travels from the gas blender 20 and flowmeter 24, through gas tubing 26 and 53, and into the gas-liquid contact device 40"; [0074], "oxygen is introduced into the system through the blender 20". At this point, there is already liquid in the gas-liquid contact device 40.), the catheter being connected to a catheter connection portion (Annotated Figure 2 below, catheter connection portion connects to gas conducting tubing 26); supplying the oxygen-containing gas to the catheter connection portion via a gas supply unit ([0074], "oxygen is introduced into the system through the [gas] blender 20”).
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Grady does not disclose sensing an internal pressure of the infusion solution container with a container pressure sensing unit; and controlling the supply of the oxygen-containing gas by the gas supply unit based on the internal pressure sensed by the container pressure sensing unit.
However, Loser teaches sensing an internal pressure of the infusion solution container with a container pressure sensing unit ([0023], "A pressure sensor 25 is arranged between the pressurized gas stub and the pressurized gas reservoir 21 and detects the internal pressure within the supply vessel 1."); and controlling the supply of the oxygen-containing gas by the gas supply unit based on the internal pressure sensed by the container pressure sensing unit ([0023], Measured values of the sensor 25 are considered by a control unit 22 for metering. Examiner interprets how the control unit 22 intakes information from the sensor 25 for metering of liquid to be the same process as the gas supply unit intaking an internal pressure value to control the amount of gas provided.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Grady to include a container pressure sensing unit able to sense internal pressure as taught by Loser in order to meter the quantity of the infused product ([0023]), in this case oxygen-containing gas. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the internal pressure sensed by the container pressure sensing unit as taught by Loser in order that the gas supply unit have the ability to process measured valves sent by the container pressure sensing unit and output controls for the metering of the infused product ([0022]), in this case oxygen-containing gas.
Regarding claim 15, in the modified method of Grady, Grady discloses supplying the oxygen-containing gas into the infusion solution container with an air supply unit (Annotated Figure 2 depicts the connection from blender 20, through catheter connection portion, to gas-liquid contact device 40. Catheter connection portion would contain an air supply unit as gas is supplied from blender 20, and the catheter connection portion is able to supply that gas to gas conducting tubing 26.); and exhausting gas from the inside of the infusion solution container with an exhaust unit ([0067], "The adjustable stopcock valve outlet and filter 37 may operate as a vent"; [0083], gas is able to exit the gas-liquid contact device by means of the adjustable stopcock valve outlet and filter 37).
Claims 3, 4, 10, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Grady in view of Loser as applied to claims 1 and 14 above, and further in view of Pile-Spellman et al. (United States Patent Application Publication No. US 2017/0173247 A1; herein, Pile-Spellman).
Regarding claim 3, in the modified device of Grady, Grady does not disclose an oxygen concentration sensing unit configured to sense an oxygen concentration of the infusion solution; and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Pile-Spellman teaches an oxygen concentration sensing unit (Fig. 1, Fig. 3, [0035] inline sensors 116 and microcontroller 122) configured to sense an oxygen concentration of the infusion solution ([0035], "Inline sensors may be coupled to the fluid reservoir to measure medical gas concentration in the medical liquid. The microcontroller determines whether a target concentration of the medical gas in the medical liquid has been achieved"; [0024], medical gas may be oxygen (O2)); and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the oxygen concentration sensed by the oxygen concentration sensing unit (Fig. 3, [0035], "If the target concentration has not been achieved, steps 206 and 208 may be repeated until the inline sensors indicate gas concentration at the target concentration."; [0031], microcontroller 122 instructs medical gas cylinder with regulator 102 when to re-gas. Examiner interprets how medical gas cylinder with regulator 102 is able to re-gas based on concentration level to be the same process as the gas supply unit intaking a concentration value to control the amount of gas provided.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include an oxygen concentration sensing unit for sensing oxygen concentration as taught by Pile-Spellman in order to help determine whether a target concentration of the medical gas in the medical liquid has been achieved ([0035]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the oxygen concentration sensed by the oxygen concentration sensing unit as taught by Loser in order that the gas supply unit have the ability to gas the infusion solution to a desired gas concentration ([0031]).
Regarding claim 4, in the modified device of Grady, Grady does not disclose a pressure adjustment unit configured to adjust an internal pressure of the infusion solution container; and wherein the pressure adjustment unit is configured to adjust the internal pressure based on the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Loser teaches a pressure adjustment unit (pressure controller 20) configured to adjust an internal pressure of the infusion solution container ([0022], "the pressure controller 20 receives the input from the control unit 22 for the pressure to be adjusted within the supply vessel 1"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include a pressure adjustment unit for adjusting the internal pressure as taught by Loser in order to provide the device with an electrically drivable way to adjust pressure within thew infusion solution container ([0021]-[0022]).
Further, Pile-Spellman wherein the pressure adjustment unit is configured to adjust the internal pressure based on the oxygen concentration sensed by the oxygen concentration sensing unit ([0031], The microcontroller 122 is connected to inline sensors 116, which sense concentration, and medical gas cylinder with regulator 102, which controls gas output. The regulator of medical gas cylinder 102 may limit an amount of gas pressure allowed in fluid reservoir 112. Since the microcontroller 112 collects the concentration data and controls the cylinder that regulates pressure of the fluid reservoir, it would have been obvious to someone in the art to base pressure adjustment off of the collected concentration value.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure adjustment unit taught by Loser of the modified device disclosed by Grady to specifically establish a correlation between the pressure adjustment unit and oxygen concentration of the infusion solution ([0029], [0031], [0034]).
Regarding claim 10, in the modified device of Grady, Grady does not disclose an oxygen concentration sensing unit configured to sense an oxygen concentration of the infusion solution; a pressure adjustment signal transmission unit configured to transmit a pressure adjustment signal for adjusting an internal pressure of the infusion solution container; and wherein the pressure adjustment signal transmission unit is configured to transmit the pressure adjustment signal based on the internal pressure sensed by the container pressure sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Pile-Spellman teaches an oxygen concentration sensing unit (Fig. 1, Fig. 3, [0035], inline sensors 116 and microcontroller 122) configured to sense an oxygen concentration of the infusion solution ([0035], "Inline sensors may be coupled to the fluid reservoir to measure medical gas concentration in the medical liquid. The microcontroller determines whether a target concentration of the medical gas in the medical liquid has been achieved"; [0024], medical gas may be oxygen (O2)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include an oxygen concentration sensing unit for sensing oxygen concentration as taught by Pile-Spellman in order to help determine whether a target concentration of the medical gas in the medical liquid has been achieved ([0035]).
Further, Loser teaches a pressure adjustment signal transmission unit (control unit 22) configured to transmit a pressure adjustment signal for adjusting an internal pressure of the infusion solution container ([0022], control unit 22 sends a signal when the pressure needs to be adjusted within the supply vessel 1); and wherein the pressure adjustment signal transmission unit is configured to transmit the pressure adjustment signal based on the internal pressure sensed by the container pressure sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit ([0022]-[0023], control unit 22 sends a signal regarding pressure adjustment after considering the measured valves collected by pressure sensor 25). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include a pressure adjustment signal transmission unit for transmitting a pressure adjustment signal for adjusting the internal pressure as taught by Loser in order to provide a central location for control commands to be outputted regarding metering of the oxygen-containing gas ([0022]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container pressure sensing unit as previously taught by Loser of the modified device disclosed by Grady to supply an internal pressure to the pressure adjustment signal transmission unit as taught by Loser in order for the pressure adjustment signal transmission unit to provide the commands based on measured values ([0022]-[0023]).
Regarding claim 16, in the modified method of Grady, Grady does not disclose sensing an oxygen concentration of the infusion solution with an oxygen concentration sensing unit; and controlling the supply of the oxygen-containing gas with the gas supply unit based on the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Pile-Spellman teaches sensing an oxygen concentration of the infusion solution with an oxygen concentration sensing unit (Fig. 1, Fig. 3, [0035], inline sensors 116 and microcontroller 122 sense concentration; [0035], "Inline sensors may be coupled to the fluid reservoir to measure medical gas concentration in the medical liquid. The microcontroller determines whether a target concentration of the medical gas in the medical liquid has been achieved"; [0024], medical gas may be oxygen (O2)); and controlling the supply of the oxygen-containing gas with the gas supply unit based on the oxygen concentration sensed by the oxygen concentration sensing unit (Fig. 3, [0035], "If the target concentration has not been achieved, steps 206 and 208 may be repeated until the inline sensors indicate gas concentration at the target concentration."; [0031], microcontroller 122 instructs medical gas cylinder with regulator 102 when to re-gas. Examiner interprets how medical gas cylinder with regulator 102 is able to re-gas based on concentration level to be the same process as the gas supply unit intaking a concentration value to control the amount of gas provided.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include an oxygen concentration sensing unit for sensing oxygen concentration as taught by Pile-Spellman in order to help determine whether a target concentration of the medical gas in the medical liquid has been achieved ([0035]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the oxygen concentration sensed by the oxygen concentration sensing unit as taught by Loser in order that the gas supply unit have the ability to gas the infusion solution to a desired gas concentration ([0031]).
Regarding claim 17, in the modified method of Grady, Grady does not disclose adjusting an internal pressure of the infusion solution container with a pressure adjustment unit; and adjusting the internal pressure with the pressure adjustment unit based on the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Loser teaches adjusting an internal pressure of the infusion solution container with a pressure adjustment unit ([0022], "the pressure controller 20 receives the input from the control unit 22 for the pressure to be adjusted within the supply vessel 1"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include a pressure adjustment unit for adjusting the internal pressure as taught by Loser in order to provide the device with an electrically drivable way to adjust pressure within thew infusion solution container ([0021]-[0022]).
Further, Pile-Spellman teaches adjusting the internal pressure with the pressure adjustment unit based on the oxygen concentration sensed by the oxygen concentration sensing unit ([0031], The microcontroller 122 is connected to inline sensors 116, which sense concentration, and medical gas cylinder with regulator 102, which controls gas output. The regulator of medical gas cylinder 102 may limit an amount of gas pressure allowed in fluid reservoir 112. Since the microcontroller 112 collects the concentration data and controls the cylinder that regulates pressure of the fluid reservoir, it would have been obvious to someone in the art to base pressure adjustment off of the collected concentration value.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pressure adjustment unit taught by Loser of the modified method disclosed by Grady to specifically establish a correlation between the pressure adjustment unit and oxygen concentration of the infusion solution ([0029], [0031], [0034]).
Claims 5, 6, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Grady in view of Loser as applied to claims 1 and 14 above, and further in view of Weston et al. (United States Patent Application Publication No. US 2010/0298792 A1; herein, Weston).
Regarding claim 5, in the modified device of Grady, Grady does not disclose a biological information acquisition unit configured to acquire biological information of a patient; and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the biological information acquired by the biological information acquisition unit.
However, Weston teaches a biological information acquisition unit (blood oxygen saturation level sensor 84) configured to acquire biological information of a patient ([0086], “the blood oxygen saturation level determined by the blood oxygen saturation sensor”); and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the biological information acquired by the biological information acquisition unit ([0086], [0104], If the blood oxygen saturation level falls below or rises above a predetermined value, the control device 32 may respond by controlling the vacuum pump 30 to adjust the amplitude of the negative pressure. The examiner interprets the gas supply unit controlling the supply of gas in response to acquired biological information to be obvious of the process of the control device 32 modifying the vacuum pump 30 and negative pressure in response to a measured blood oxygen saturation level). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include a biological information acquisition unit for acquisition of biological information as taught by Weston in order to automatically trigger the control device to change the magnitude or frequency of the pressure cycling ([0086]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the biological information sensed by the biological information acquisition unit as taught by Weston in order that the gas supply unit have the ability to automatically trigger the control device to change the magnitude or frequency of the pressure cycling ([0086]).
Regarding claim 6, in the modified device of Grady, Grady does not disclose the biological information includes a blood oxygen saturation, an inhaled oxygen concentration, a blood pressure, a heart rate, a respiratory rate, a tissue oxygen saturation, an arterial oxygen partial pressure, a mixed venous blood oxygen saturation, a urine oxygen partial pressure, an intravesical pressure, a brain/tissue oxygen saturation, a urine amount, a body temperature, or a cardiac output.
However, Weston teaches the biological information includes a blood oxygen saturation, an inhaled oxygen concentration, a blood pressure, a heart rate, a respiratory rate, a tissue oxygen saturation, an arterial oxygen partial pressure, a mixed venous blood oxygen saturation, a urine oxygen partial pressure, an intravesical pressure, a brain/tissue oxygen saturation, a urine amount, a body temperature, or a cardiac output ([0086], “the blood oxygen saturation level determined by the blood oxygen saturation sensor”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify biological information previously taught by Weston of the modified device disclosed by Grady to specify blood oxygen saturation level as the biological information as taught by Weston in order to help determine the most optimal program for use ([0102]). Moreover, it is commonly understood in the art that blood oxygen saturation level would be directly relevant to an oxygen-containing gas infused infusion solution being inserted into a living body, as to avoid over-oxygenating the body.
Regarding claim 18, in the modified method of Grady, Grady does not disclose acquiring biological information of a patient with a biological information acquisition unit; and controlling the supply of the oxygen-containing gas with the gas supply unit based on the biological information acquired by the biological information acquisition unit.
However, Weston teaches acquiring biological information of a patient with a biological information acquisition unit ([0086], “the blood oxygen saturation level determined by the blood oxygen saturation [level] sensor”84); and controlling the supply of the oxygen-containing gas with the gas supply unit based on the biological information acquired by the biological information acquisition unit ([0086], [0104], If the blood oxygen saturation level falls below or rises above a predetermined value, the control device 32 may respond by controlling the vacuum pump 30 to adjust the amplitude of the negative pressure. The examiner interprets the gas supply unit controlling the supply of gas in response to acquired biological information to be obvious of the process of the control device 32 modifying the vacuum pump 30 and negative pressure in response to a measured blood oxygen saturation level). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include a biological information acquisition unit for acquisition of biological information as taught by Weston in order to automatically trigger the control device to change the magnitude or frequency of the pressure cycling ([0086]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the biological information sensed by the biological information acquisition unit as taught by Weston in order that the gas supply unit have the ability to automatically trigger the control device to change the magnitude or frequency of the pressure cycling ([0086]).
Regarding claim 19, in the modified method of Grady, Grady does not disclose the biological information includes a blood oxygen saturation, an inhaled oxygen concentration, a blood pressure, a heart rate, a respiratory rate, a tissue oxygen saturation, an arterial oxygen partial pressure, a mixed venous blood oxygen saturation, a urine oxygen partial pressure, an intravesical pressure, a brain/tissue oxygen saturation, a urine amount, a body temperature, or a cardiac output.
However, Weston teaches the biological information includes a blood oxygen saturation, an inhaled oxygen concentration, a blood pressure, a heart rate, a respiratory rate, a tissue oxygen saturation, an arterial oxygen partial pressure, a mixed venous blood oxygen saturation, a urine oxygen partial pressure, an intravesical pressure, a brain/tissue oxygen saturation, a urine amount, a body temperature, or a cardiac output ([0086], “the blood oxygen saturation level determined by the blood oxygen saturation sensor”). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify biological information previously taught by Weston of the modified device disclosed by Grady to specify blood oxygen saturation level as the biological information as taught by Weston in order to help determine the most optimal program for use ([0102]). Moreover, it is commonly understood in the art that blood oxygen saturation level would be directly relevant to an oxygen-containing gas infused infusion solution being inserted into a living body, as to avoid over-oxygenating the body.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Grady in view of Loser as applied to claim 1 above, and further in view of Kondoh et al. (United States Patent Application Publication No. US 2014/0221925 A1; herein, Kondoh).
Regarding claim 7, in the modified device of Grady, Grady does not disclose a remaining amount sensing unit configured to sense a remaining amount of the infusion solution in the infusion solution container; and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the remaining amount of the infusion solution acquired by the remaining amount sensing unit.
However, Kondoh teaches a remaining amount sensing unit (remaining pharmaceutical sensor (encoder 26)) configured to sense a remaining amount of the infusion solution in the infusion solution container ([0111], “The amount of pharmaceutical remaining in the pharmaceutical syringe 4 can be sensed by this remaining pharmaceutical sensor (encoder 26).”); and wherein the gas supply unit is configured to control the supply of the oxygen-containing gas based on the remaining amount of the infusion solution acquired by the remaining amount sensing unit (FIG. 10, [0010], [0111], Controller 7 is connected to the remaining pharmaceutical sensor, in which the controller 7 can display warnings to the user based to the amount of pharmaceutical remaining in the pharmaceutical syringe 4. The examiner interprets the process of the controller intaking information from the remaining pharmaceutical sensor and producing an output to be similar to that of the gas supply unit outputting oxygen-containing gas based on the remaining amount sensed.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include a remaining amount sensing unit for sensing a remaining amount of the infusion solution as taught by Kondoh in order to protect the user from unproper device use ([0111]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the remaining amount of the infusion solution acquired by the remaining amount sensing unit as taught by Kondoh in order that the gas supply unit have the ability to protect the user from incorrect device use ([0111]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Grady in view of Loser as applied to claim 1 above, and further in view of Pile-Spellman and Pouchoulin (United States Patent Application Publication No. US 2019/0160216 A1).
Regarding claim 9, in the modified device of Grady, Grady does not disclose an oxygen concentration sensing unit configured to sense an oxygen concentration of the infusion solution; a temperature sensing unit configured to sense a temperature of the infusion solution; a temperature adjustment signal transmission unit configured to transmit a temperature adjustment signal for adjusting the temperature of the infusion solution; and wherein the temperature adjustment signal transmission unit is configured to transmit the temperature adjustment signal based on the temperature sensed by the temperature sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Pile-Spellman teaches an oxygen concentration sensing unit (Fig. 1, Fig. 3, [0035], inline sensors 116 and microcontroller 122) configured to sense an oxygen concentration of the infusion solution ([0035], "Inline sensors may be coupled to the fluid reservoir to measure medical gas concentration in the medical liquid. The microcontroller determines whether a target concentration of the medical gas in the medical liquid has been achieved"; [0024], medical gas may be oxygen (O2)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include an oxygen concentration sensing unit for sensing oxygen concentration as taught by Pile-Spellman in order to help determine whether a target concentration of the medical gas in the medical liquid has been achieved ([0035]).
Further, Loser teaches a temperature sensing unit (temperature sensor 24) configured to sense a temperature of the infusion solution ([0023], "the temperature of the anesthetic 6 is additionally detected with a temperature sensor 24"). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include a temperature sensing unit able to sense a temperature of the infusion solution as taught by Loser in order to meter the quantity of the infused product ([0023]), in this case oxygen-containing gas.
Grady in view of Loser and Pile-Spellman still does not disclose a temperature adjustment signal transmission unit configured to transmit a temperature adjustment signal for adjusting the temperature of the infusion solution; and wherein the temperature adjustment signal transmission unit is configured to transmit the temperature adjustment signal based on the temperature sensed by the temperature sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Pouchoulin teaches a temperature adjustment signal transmission unit (control unit 25) configured to transmit a temperature adjustment signal for adjusting the temperature of the infusion solution ([0126], control unit 25 is configured to control said recirculation pump 17 and said fluid warming device 13 in order to adjust the temperature of blood in the blood circuit.); and wherein the temperature adjustment signal transmission unit is configured to transmit the temperature adjustment signal based on the temperature sensed by the temperature sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit ([0126]-[0133], Control unit 25 communicates with the fluid warming device 13 and the recirculation pump 17 to bring and keep the measured blood temperature equal to or close to the preset blood temperature. The communication is based on signals sent from the blood temperature sensor 22 to the control unit 25.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to include a temperature adjustment signal transmission unit able to adjust a temperature of the infusion solution, based on a received temperature sensed by the temperature sensing unit as taught by Pouchoulin in order to bring the measured infusion solution temperature equal or close to a temperature which would be acceptable to infuse into a body ([0129]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Grady in view of Loser as applied to claim 1 above, and further in view of Electra Brown et al. (United States Patent Application Publication No. US 2007/0089796 A1; herein, Electra Brown).
Regarding claim 11, in the modified device of Grady, Grady discloses a first connection portion (Annotated on Figure 2 below, first connection portion of valve 16) connected to a supply source of a first gas containing an oxygen gas ([0079], "the gas travels from the gas blender 20 and flowmeter 24, through gas tubing 26 and 53, and into the gas-liquid contact device 40"; [0074], "oxygen is introduced into the system through the blender 20"); a second connection portion (Annotated on Figure 2 below, second connection portion of valve 16) connected to a supply source of a second gas different from the first gas ([0073], "a high pressure tank 120 connected through a regulator and tubing 110 to the inlet four-way stopcock valve 16. The tank 120 includes a different gas than is introduced through the gas blender 20 and flowmeter 24.").
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Grady does not explicitly disclose wherein the second gas contains nitrogen, argon, nitrogen monoxide, nitrous oxide gas, or carbon dioxide; and the gas supply unit is configured to prepare the oxygen-containing gas by mixing the first gas and the second gas.
However, Electra Brown teaches wherein the second gas contains nitrogen, argon, nitrogen monoxide, nitrous oxide gas, or carbon dioxide (FIG. 2, [0030], one of the gasses to be mixed is nitrogen); and the gas supply unit is configured to prepare the oxygen-containing gas by mixing the first gas and the second gas (FIG. 2, [0040], oxygen and nitrogen are mixed). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified device disclosed by Grady to specify the second gas as nitrogen, as well as specify that the two gasses are to be mixed as taught by Electra Brown in order to produce a medical grade air product that satisfies the United States Pharmacopeia requirements or other requirements having specified oxygen concentrations ([0022]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Grady in view of Loser as applied to claim 12 above, and further in view of Burnett et al. (US 2014/0005650 A1).
Regarding claim 13, in the modified system of Grady, Grady discloses a supply lumen (tube 53) configured to supply the oxygen-containing gas into the infusion solution container ([0079], "the gas travels from the gas blender 20 and flowmeter 24, through gas tubing 26 and 53, and into the gas-liquid contact device 40"); and
Grady does not explicitly disclose as part of the catheter an exhaust lumen configured to exhaust gas from the inside of the infusion solution container.
However, Burnett teaches an exhaust lumen (exhaust catheter 222) configured to exhaust gas from the inside of the infusion solution container ([0200], [0207], Cooling probe positioned within the balloon 174 may be variously configured, but completes the same function of withdrawing fluid or gas from an interior space out through exhaust tube 213). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified system disclosed by Grady include an exhaust lumen as part of the catheter as taught by Burnett in order to evacuate exhausted or excess gas from an interior container ([0192]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Grady in view of Loser as applied to claim 14 above, and further in view of Kondoh, Pile-Spellman, and Pouchoulin.
Regarding claim 20, in the modified method of Grady, Grady does not disclose one or more of:
sensing a remaining amount of the infusion solution in the infusion solution container with a remaining amount sensing unit, and controlling the supply of the oxygen-containing gas with the gas supply unit based on the remaining amount of the infusion solution acquired by the remaining amount sensing unit;
sensing a temperature of the infusion solution with a temperature sensing unit, and controlling the supply of the oxygen-containing gas with the gas supply unit based on the temperature sensed by the temperature sensing unit;
sensing an oxygen concentration of the infusion solution with an oxygen concentration sensing unit, transmitting a temperature adjustment signal for adjusting the temperature of the infusion solution with a temperature adjustment signal transmission unit, and transmitting the temperature adjustment signal based on the temperature sensed by the temperature sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit; and
sensing the oxygen concentration of the infusion solution with the oxygen concentration sensing unit, transmitting a pressure adjustment signal with a pressure adjustment signal transmission unit for adjusting an internal pressure of the infusion solution container, and transmitting the pressure adjustment signal based on the internal pressure sensed by the container pressure sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit.
However, Loser teaches sensing a temperature of the infusion solution with a temperature sensing unit ([0023], "the temperature of the anesthetic 6 is additionally detected with a temperature sensor 24"), and controlling the supply of the oxygen-containing gas with the gas supply unit based on the temperature sensed by the temperature sensing unit ([0023], Measured values of the sensor 24 are considered by a control unit 22 for metering. Examiner interprets how the control unit 22 intakes information from the sensor 24 for metering of liquid to be the same process as the gas supply unit intaking a temperature value to control the amount of gas provided.); transmitting a pressure adjustment signal with a pressure adjustment signal transmission unit for adjusting an internal pressure of the infusion solution container ([0022], control unit 22 sends a signal when the pressure needs to be adjusted within the supply vessel 1), and transmitting the pressure adjustment signal based on the internal pressure sensed by the container pressure sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit ([0022]-[0023], control unit 22 sends a signal regarding pressure adjustment after considering the measured valves collected by pressure sensor 25). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include a temperature sensing unit able to sense a temperature of the infusion solution as taught by Loser in order to meter the quantity of the infused product ([0023]), in this case oxygen-containing gas. Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the temperature sensed by the temperature sensing unit as taught by Loser in order that the gas supply unit have the ability to process measured valves sent by the temperature sensing unit and output controls for the metering of the infused product ([0022]), in this case oxygen-containing gas. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include a pressure adjustment signal transmission unit for transmitting a pressure adjustment signal for adjusting the internal pressure as taught by Loser in order to provide a central location for control commands to be outputted regarding metering of the oxygen-containing gas ([0022]). Finally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container pressure sensing unit as previously taught by Loser of the modified method disclosed by Grady to supply an internal pressure to the pressure adjustment signal transmission unit as taught by Loser in order for the pressure adjustment signal transmission unit to provide the commands based on measured values ([0022]-[0023]).
Further, Kondoh teaches sensing a remaining amount of the infusion solution in the infusion solution container with a remaining amount sensing unit ([0111], “The amount of pharmaceutical remaining in the pharmaceutical syringe 4 can be sensed by this remaining pharmaceutical sensor (encoder 26).”), and controlling the supply of the oxygen-containing gas with the gas supply unit based on the remaining amount of the infusion solution acquired by the remaining amount sensing unit (FIG. 10, [0010], [0111], Controller 7 is connected to the remaining pharmaceutical sensor, in which the controller 7 can display warnings to the user based to the amount of pharmaceutical remaining in the pharmaceutical syringe 4. The examiner interprets the process of the controller intaking information from the remaining pharmaceutical sensor and producing an output to be similar to that of the gas supply unit outputting oxygen-containing gas based on the remaining amount sensed.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include a remaining amount sensing unit for sensing a remaining amount of the infusion solution as taught by Kondoh in order to protect the user from unproper device use ([0111]). Further, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified gas supply unit disclosed by Grady to control supply of the oxygen-containing gas based on the remaining amount of the infusion solution acquired by the remaining amount sensing unit as taught by Kondoh in order that the gas supply unit have the ability to protect the user from incorrect device use ([0111]).
Further, Pile-Spellman teaches sensing an oxygen concentration of the infusion solution with an oxygen concentration sensing unit (Fig. 1, Fig. 3, [0035], inline sensors 116 and microcontroller 122 sense concentration; [0035], "Inline sensors may be coupled to the fluid reservoir to measure medical gas concentration in the medical liquid. The microcontroller determines whether a target concentration of the medical gas in the medical liquid has been achieved"; [0024], medical gas may be oxygen (O2)). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include an oxygen concentration sensing unit for sensing oxygen concentration as taught by Pile-Spellman in order to help determine whether a target concentration of the medical gas in the medical liquid has been achieved ([0035]).
However, Pouchoulin teaches transmitting a temperature adjustment signal for adjusting the temperature of the infusion solution with a temperature adjustment signal transmission unit ([0126], control unit 25 is configured to control said recirculation pump 17 and said fluid warming device 13 in order to adjust the temperature of blood in the blood circuit.), and transmitting the temperature adjustment signal based on the temperature sensed by the temperature sensing unit or the oxygen concentration sensed by the oxygen concentration sensing unit ([0126]-[0133], Control unit 25 communicates with the fluid warming device 13 and the recirculation pump 17 to bring and keep the measured blood temperature equal to or close to the preset blood temperature. The communication is based on signals sent from the blood temperature sensor 22 to the control unit 25.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Grady to include a temperature adjustment signal transmission unit able to adjust a temperature of the infusion solution, based on a received temperature sensed by the temperature sensing unit as taught by Pouchoulin in order to bring the measured infusion solution temperature equal or close to a temperature which would be acceptable to infuse into a body ([0129]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Spears et al. (United States Patent US 5,693,017 A) is considered relevant prior art with regards to supplying oxygen-gas to a supersaturated solution for infusion.
Spears et al. (United States Patent US 6,241,802 A) is considered relevant prior art with regards to a system for providing gas to a supersaturated fluid for infusion.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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