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 .
Specification
The disclosure is objected to because of the following informalities:
The reference characters “23a, 23a’” are both referring to “separate element” on page 17, line 24 and “liquid-retaining filter membrane” on page 17, line 23.
The reference character “25” has been used to refer to “patient port” on page 19, line 13 and “patient connection” on page 19, line 18.
Appropriate correction is required.
Claim Objections
Claims 2, 8, 9 and 13 are objected to because of the following informalities:
Regarding claim 2, lines 5 and 8, the recitation “the first” appears to be amended to recite “the first active operating state” in order to refer to the same limitation consistently in the entire claim.
Claim 8 recites the limitation “the same housing” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 9, line 4, the recitation “a conduit” appears to be amended to recite “the conduit” in order to refer to “a conduit” recited in claim 1.
Regarding claim 9, line 5, the recitation “a liquid-retaining filter membrane” appears to be amended to recite “the liquid-retaining filter membrane” in order to refer to “a liquid-retaining filter membrane” recited in claim 1.
Regarding claim 13, last line, the recitation “the patient connection join” appears to be amended to recite “the patient connection joint” in order to recite same limitation consistently in all the claims.
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 limitation(s) is/are: “unit” in claim 4.
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.
Claims 2, 4, 5, 11, 12 and 14-15 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.
Regarding claim 2, the recitation of “wherein in the first active operating state” in line 2, “for switching the device from the first to the second active operating state” in line 5, “switching the device from the first to the second active operating state” in lines 8-9 renders the claim indefinite because the claim is unclear regarding the recitation of “a first active operating state” and “a second active operating state” is positively claimed as a part of claimed invention. According to claim 1, upon which claim 2 depends upon, recites that the control device is further configured to emit … a communication signal to a data connection between the device and a unit … and/or to switch, based on the control signal, the device from a first active operating state to a second active operating state. For examination purposes, examiner construes that claim 2 positively recites “first active operating state” and “second active operating state” as a part of claimed invention.
Regarding claim 2, the recitation of “a further container as a second container” renders the claim indefinite because the claim is unclear if “a further container as a second container” is positively claimed as a part of claimed device. For examination purposes, examiner construes “a further container as a second container” is positively claimed as a part of claimed device.
Regarding claim 2, line 8, the recitation “a multi-way valve” renders the claim indefinite because the claim is unclear if “a multi-way valve” is positively claimed as a part of claimed device. For examination purposes, examiner construes “a multi-way valve” is positively claimed as a part of claimed invention.
Regarding claim 2, lines 5-6, the recitation “a further pump is controlled as a second pump” is positively claimed as a part of claimed device. For examination purposes, examiner construes “a further pump is controlled as a second pump” is positively claimed as part of claimed device.
Regarding claim 2, line 6, the recitation “as a second pump in addition to or instead of the pump” renders the claim indefinite because the claim is unclear if a second pump is replacing the pump claimed in claim 1 or is being controlled solely by second pump. For examination purposes, examiner construes that second pump is in addition to the pump claimed in claim 1.
Regarding claim 4, the recitation of “a further container” in line 6 renders the claim indefinite because the claim is unclear if “a further container” is positively claimed as a part of the claimed invention.
Regarding claim 4, the recitation of “a communication signal” in line 3, “a data connection” in line 4 and “a unit” in line 4 renders claim indefinite because the claim is unclear if these limitations refer to “a communication signal”, “a data connection” and “a unit” in claim 1, line 19 or additional. For examination purposes, examiner construes that “a data connection”, “a unit” and “a communication signal” in claim 4 refers to “a data connection”, a communication signal” and “a unit” in claim 1.
Regarding claim 5, the recitation of “the liquid-retaining filter membrane is arranged between the inlet and the outlet” in lines 6-7 renders the claim indefinite because claim 5 indicates the inlet and the outlet of a drip chamber and claim 1 recites “a conduit comprising a liquid-retaining filter membrane”. Therefore, the claim is unclear regarding how a liquid-retaining filter membrane be located between the inlet and the outlet while at the same time being in the conduit. For examination purposes, examiner construes that if the liquid-retaining filter membrane is located anywhere along the conduit or within the drip chamber wherein the drip chamber is located on the conduit then the claim is construed as meeting the claimed limitations.
Regarding claim 11, line 3, the recitation “at least two infusion or transfusion sets” renders the claim indefinite because the claim is unclear regarding whether “at least two infusion or transfusion sets” refer to “at least one infusion or transfusion set” recited in claim 9 or additional. For examination purposes, examiner construes that “at least two infusion or transfusion sets” refer to “at least one infusion or transfusion set”.
Regarding claim 12, line 3, the recitation “an infusion or transfusion set” renders the claim indefinite because the claim is unclear if “an infusion or transfusion set” refers to “at least one infusion or transfusion set” in claim 9 or additional. For examination purposes, examiner construes that “an infusion or transfusion set” in claim 12 refers to “an infusion or transfusion set” recited in claim 9.
Claim 14 recites a method of controlling a device without reciting an active step of performing the method. Therefore, the claim does not positively recite the method of actually practicing thereby rendering the claim indefinite (see MPEP 2173.05(q)).
Claim 15 being dependent on claim 14 is also rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim further discloses the limitations of the conduit but conduit is not positively claimed as a part of claimed device therefore, claim 5 fails to further limit the scope of the claimed invention (i.e. the device). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 1-5, 7-10, 13, 14, 15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Archibald et al. (US 4,714,463) in view of Whitaker et al. (US 2016/0213862 A1) further in view of Vanderveen et al. (US 2005/0145009 A1).
Regarding claim 1, Archibald discloses a device (figure 1 excluding the conduits i.e. elements 30, 40, 22, 24, 46, 34, 42, 50) for administering an infusion or transfusion of a liquid from a container 14, 16,
wherein the device comprises:
a pump 20 for pumping the liquid via a conduit 30, 40, 22, 24, 46,
a pressure measuring device 96 (figure 3, column 4, lines 29-34) for acquiring measurement values and
a control device 94,
wherein the control device 94 is configured to detect a change in the pressure (column 4, lines 29-34) based on the measurement values,
wherein the control device (column 4, lines 29-36, “empty bags”) is further configured to determine, based on the change in the pressure, whether pumping of the liquid is to be stopped,
wherein the control device (column 4, lines 29-36, “empty bags” and column 5, lines 14-40) is further configured to generate a control signal when pumping of the liquid is to be stopped, and wherein the control device is further configured to emit, based on the control signal, a communication signal (column 5, lines 32-40) to a data connection between the device and a unit 86 configured to read the communication signal and/or to switch, based on the control signal (column 5, lines 14-24), the device from a first active operating state (state of operating either element 14 or 16) to a second active operating state (state of operating other of element 16 or 14).
Archibald is silent regarding a conduit comprising a liquid-retaining filter membrane.
However, Whitaker discloses a design of an IV set with a membrane wherein a conduit 103, 303a, 303b (figures 1A, 3) comprising a liquid-retaining filter 105, 305 for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the conduit of Archibald to incorporate a liquid-retaining filter membrane as taught by Whitaker for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Archibald is further silent regarding a pressure measuring device corresponding to a pump-inlet-side pressure being present inside the conduit between the pump and the liquid-retaining filter membrane.
However, Vanderveen teaches a design of a system (figure 4) comprising a pressure measuring device 225 corresponding to a pump-inlet-side pressure being present inside the conduit 215 between the pump 222 and a drip chamber 210 for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the pressure measuring device of Archibald to incorporate a pressure measuring device corresponding to a pump-inlet-side pressure being present inside the conduit between the pump and a drip chamber as taught by Archibald for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Furthermore, Archibald modified in view of Whitaker and Vanderveen will result in a modified device comprising a pressure measuring device corresponding to a pump-inlet-side pressure being present inside the conduit between the pump and the liquid-retaining filter membrane. In addition, according to MPEP 2144.04 (VI)(C), it is obvious to one of ordinary skill in the art, to rearrange the components if the rearrangement does not modify the device operation. Therefore, rearranging the placement of Vanderveen’s pressure measuring device to be placed between the pump and the liquid-retaining filter membrane of a modified device formed by Archibald in view of Whitaker since the rearrangement does not change the operation of the device.
Regarding claim 2, Archibald discloses wherein in the first active operating state (state of operating either element 14 or 16, column 5, lines 14-28), the liquid is delivered to the patient as a first liquid form the container as a first container and in the second active operating state (state of operating other of element 16 or 14, column 5, lines 14-28) a further liquid is delivered to the patient as a second liquid from a further container as a second container, and/or wherein, for switching the device from the first to the second active operating state, a further pump is controlled as a second pump in addition to or instead of the pump as a first pump, and/or wherein a multi-way valve is controlled for switching the device from the first to the second active operating state.
Regarding claim 3, Archibald discloses wherein the control device is configured to detect a drop in the pressure on the basis of the measurement values (column 4, lines 29-34) but is silent regarding wherein the control device is configured to detect a drop in the pump-inlet-side pressure on the basis of the measurement values and to determine on the basis of the drop whether the pumping of the liquid is to be stopped and the control signal is to be generated, and/or wherein the control device is configured to determine whether the pumping of the liquid is to be stopped and the control signal is to be generated by comparing the measurement values or a difference quotient calculated on the basis of the measurement values or differential quotient calculated on the basis for the measurement values with a threshold value.
However, Vanderveen teaches wherein the control device 75 (paragraphs 0047 and 0049) is configured to detect a drop in the pump-inlet-side pressure on the basis of the measurement values and to determine on the basis of the drop whether the pumping of the liquid is to be stopped and the control signal is to be generated, and/or wherein the control device 75 (paragraphs 0047 and 0049) is configured to determine whether the pumping of the liquid is to be stopped and the control signal is to be generated by comparing the measurement values or a difference quotient calculated on the basis of the measurement values or differential quotient calculated on the basis for the measurement values with a threshold value for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the pressure sensor of Archibald to incorporate wherein the control device is configured to detect a drop in the pump-inlet-side pressure on the basis of the measurement values and to determine on the basis of the drop whether the pumping of the liquid is to be stopped and the control signal is to be generated, and/or wherein the control device is configured to determine whether the pumping of the liquid is to be stopped and the control signal is to be generated by comparing the measurement values or a difference quotient calculated on the basis of the measurement values or differential quotient calculated on the basis for the measurement values with a threshold value as taught by Vanderveen for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Regarding claim 4, Archibald discloses wherein the control device 94 is further configured to check whether the pumping of the liquid is completed (column 5, lines 17-24, column 5, lines 32-40) and whether a communication signal is to be emitted to a data connection (column 5, lines 32-40) between the device and a unit 86, which is configured to read the communication signal, and/or whether the device is to be caused to deliver a further liquid from a further container to the patient (column 5, lines 14-28), wherein the control device is further configured to generate the control signal depending on the result of the checking (column 5, lines 14-40).
Regarding claim 5, Archibald discloses wherein the conduit 30, 40 comprises a drip chamber 28, 38 arranged upstream of the pump 20, wherein the drip chamber comprises 28, 38 an inlet (an opening in elements 28, 38 that receives liquid from elements 14 and 16 respectively) through which the liquid from the container 14, 16 may enter in the form of drops, and wherein the drip chamber comprises an outlet (an opening in elements 28, 38 through which liquid exits out of elements 28, 38), through which the liquid may flow into the remaining conduit. Archibald is silent regarding wherein the liquid-retaining filter membrane is arranged between the inlet and the outlet.
However, Whitaker teaches wherein the liquid-retaining filter membrane 105 is arranged between the inlet (an opening in element 101 through which liquid enters from element 102 into element 101) and the outlet 101a for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the drip chamber of Archibald to incorporate wherein the liquid-retaining filter membrane is arranged between the inlet and the outlet as taught by Whitaker for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Regarding claim 7, Archibald discloses wherein the control device is configured to switch a multi-way valve 18 arranged in the conduit 30, 40, 22 24 46 such that subsequently to delivering the liquid as the first liquid (column 5, lines 14-32), a further liquid as a second liquid is delivered to the patient with the pump 20.
Regarding claim 8, Archibald is silent regarding wherein the pressure measuring device and the pump are arranged in the same housing.
However, Vanderveen teaches wherein the pressure measuring device 225 and the pump 222 are arranged in the same housing (housing of element 220) for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of Archibald to incorporate wherein the pressure measuring device and the pump are arranged in the same housing as taught by Vanderveen for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Regarding claim 9, Archibald discloses a system 10 (figure 1) comprising: a device (figure 1 excluding the conduits i.e. elements 30, 40, 22, 24, 46, 34, 42, 50) and at least one infusion or transfusion set (set formed by elements 30, 40, 22, 24, 46) comprising a conduit 30, 40, 22, 24, 46 and a patient connection (an end of element 46 that engages with element 48). Archibald is silent regarding a conduit with a liquid-retaining filter membrane.
However, Whitaker discloses a conduit 103, 303a, 303b (figures 1A, 3) with a liquid-retaining filter 105, 305 for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the conduit of Archibald to incorporate a liquid-retaining filter membrane as taught by Whitaker for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Regarding claim 10, Archibald is silent regarding wherein the liquid-retaining filter membrane is an air-stop membrane, and/or wherein the liquid-retaining filter membrane is a hydrophilic and/or porous liquid-retaining membrane.
However, Whitaker teaches wherein the liquid-retaining filter membrane 105, 305 is an air-stop membrane (paragraph 0047), and/or wherein the liquid-retaining filter membrane is a hydrophilic and/or porous liquid-retaining membrane (paragraph 0017, lines 4-8) for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the system of Archibald to incorporate wherein the liquid-retaining filter membrane is an air-stop membrane, and/or wherein the liquid-retaining filter membrane is a hydrophilic and/or porous liquid-retaining membrane as taught by Whitaker for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Regarding claim 13, Archibald discloses wherein the conduit 30, 40, 22, 24, 46 of the at least one infusion or transfusion set (set formed by elements 30, 40, 22, 24, 46) comprises a multi-way valve 18 at which at least a first 30 and a second 40 supply line and a discharge line 46 connected to the patient joint (end of element 46 connected to element 48).
Regarding claim 14, Archibald discloses a method (column 5, lines 13-40) of controlling a device (figure 1 excluding the conduits i.e. elements 30, 40, 22, 24, 46, 34, 42, 50) for administering an infusion or transfusion of a liquid from a container 14, 16,
wherein the device comprises:
a pump 20 for pumping the liquid to a patient via a conduit 30, 40, 22, 24, 46,
a pressure measuring device 96 (figure 3, column 4, lines 29-34) for acquiring measurement values and
a control device 94,
wherein the control device 94 is configured to determine a change in the pressure (column 4, lines 29-34) on the basis of the measurement values,
wherein the control device (column 4, lines 29-36, “empty bags”) is further configured to determine, on the basis of the change in the pressure, whether pumping of the liquid is to be stopped,
wherein the control device (column 4, lines 29-36, “empty bags” and column 5, lines 14-40) is further configured to generate a control signal when pumping of the liquid is to be stopped, and
wherein the control device is further configured to emit, based on the control signal, a communication signal (column 5, lines 32-40) to a data connection between the device and a unit 86 configured to read the communication signal and/or to switch, based on the control signal (column 5, lines 14-24), the device from a first active operating state (state of operating either element 14 or 16) to a second active operating state (state of operating other of element 16 or 14).
Archibald is silent regarding a conduit comprising a liquid-retaining filter membrane.
However, Whitaker discloses a design of an IV set with a membrane wherein a conduit 103, 303a, 303b (figures 1A, 3) comprising a liquid-retaining filter 105, 305 for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the conduit of Archibald to incorporate a liquid-retaining filter membrane as taught by Whitaker for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Archibald is further silent regarding a pressure measuring device corresponding to a pump-inlet-side pressure being present inside the conduit between the pump and the liquid-retaining filter membrane.
However, Vanderveen teaches a design of a system (figure 4) comprising a pressure measuring device 225 corresponding to a pump-inlet-side pressure being present inside the conduit 215 between the pump 222 and a drip chamber 210 for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the pressure measuring device of Archibald to incorporate a pressure measuring device corresponding to a pump-inlet-side pressure being present inside the conduit between the pump and a drip chamber as taught by Archibald for the purpose of determining a container nearing to empty or being empty in an inexpensive yet reliable manner thereby taking necessary actions as needed (paragraph 0011, lines 7).
Furthermore, Archibald modified in view of Whitaker and Vanderveen will result in a modified device comprising a pressure measuring device corresponding to a pump-inlet-side pressure being present inside the conduit between the pump and the liquid-retaining filter membrane. In addition, according to MPEP 2144.04 (VI)(C), it is obvious to one of ordinary skill in the art, to rearrange the components if the rearrangement does not modify the device operation. Therefore, rearranging the placement of Vanderveen’s pressure measuring device to be placed between the pump and the liquid-retaining filter membrane of a modified device formed by Archibald in view of Whitaker since the rearrangement does not change the operation of the device.
Regarding claim 15, Archibald discloses wherein in the first active operating state (state of operating either element 14 or 16, column 5, lines 14-28), the liquid is delivered to the patient as a first liquid form the container as a first container and in the second active operating state (state of operating other of element 16 or 14, column 5, lines 14-28) a further liquid is delivered to the patient as a second liquid from a further container as a second container, and/or wherein, for switching the device from the first to the second active operating state, a further pump is controlled as a second pump in addition to or instead of the pump as a first pump, and/or wherein a multi-way valve is controlled for switching the device from the first to the second active operating state.
Regarding claim 17, Archibald is silent regarding wherein the liquid-retaining filter membrane is arranged in an outlet region of the drip chamber.
However, Whitaker teaches wherein the liquid-retaining filter membrane 105 is arranged in an outlet region (region of element 101 where element 105 is present) of the drip chamber 101 for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of Archibald to incorporate wherein the liquid-retaining filter membrane is arranged in an outlet region of the drip chamber as taught by Whitaker for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Regarding claim 18, Archibald is silent regarding wherein the conduit comprises a drip chamber and wherein the liquid-retaining filter membrane is arranged in an outlet region of the drip chamber.
However, Whitaker teaches wherein the conduit 103 (figure 1A) comprising a liquid-retaining filter 105 and wherein the liquid-retaining filter membrane 105 is arranged in an outlet region (region of element 101 where element 105 is present) of the drip chamber 101 for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the system of Archibald to incorporate wherein the conduit comprises a drip chamber and wherein the liquid-retaining filter membrane is arranged in an outlet region of the drip chamber as taught by Whitaker for the purpose of preventing air from entering into the tubing and removing the requirement of re-priming the conduit when coupling the conduit to a new fluid source (paragraph 0015, lines 1-9).
Regarding claim 19, Archibald discloses wherein the multiport valve 18 (column 3, lines 29-34) is a magnetic multiport valve and/or an actuator-operated multiport valve.
Claim(s) 6, 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Archibald et al. (US 4,714,463) in view of Whitaker et al. (US 2016/0213862 A1) in view of Vanderveen et al. (US 2005/0145009 A1) and further in view of Halbert et al. (US 2015/0025497 A1).
Regarding claim 6, Archibald/Whitaker/Vanderveen (hereinafter referred as “modified Archibald”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Archibald is silent regarding wherein the device comprises, in addition to the pump as first pump for pumping the liquid, at least one further pump as a second pump for pumping a further liquid to the patient, wherein the control device is configured to deactivate the first pump and activate the second pump to cause the further liquid to be delivered to the patient by the second pump.
However, Halbert teaches a design of a device 20 (figure 1) for infusing multiple fluids comprising wherein the device 20 comprises, in addition to the pump (one of the pumps 24, 22, 26, 28) as first pump for pumping the liquid, at least one further pump as a second pump (other of the pumps 22, 24, 26, 28) for pumping a further liquid to the patient, wherein the control device 60 (paragraph 0025, lines 1-9, the appropriate programming instructions could be provided so that element 60 could deactivate the first pump and activate the second pump on appropriate times) is configured to deactivate the first pump and activate the second pump to cause the further liquid to be delivered to the patient by the second pump for the purpose of using a well-known alternative approach to control the liquid flow from multiple containers (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Archibald to incorporate wherein the device comprises, in addition to the pump as first pump for pumping the liquid, at least one further pump as a second pump for pumping a further liquid to the patient, wherein the control device is configured to deactivate the first pump and activate the second pump to cause the further liquid to be delivered to the patient by the second pump as taught by Halbert for the purpose of using a well-known alternative approach to control the liquid flow from multiple containers (paragraph 0018).
Examiner further construes that since modified Archibald already discloses the stopping of fluid from one container and activate fluid from another container by controlling valves (column 5, lines 14-40), one of ordinary skill in the art when modifying modified Archibald would modify in view of Halbert such that instead of controlling valves, the device will control the multiple pumps to achieve the same results. Thus, modified Archibald modified in view of Halbert will result in having the control device is configured to deactivate the first pump and activate the second pump to cause the further liquid to be delivered to the patient.
Regarding claim 11, modified Archibald discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 9. Archibald further discloses the device comprises at least a first pump 20, wherein the system comprises at least two infusion or transfusion sets (set formed by elements 30, 40, 22, 24, 46) but is silent regarding a second pump and wherein the first pump and the second pump are each associated with one of the at least two infusion or transfusion sets.
However, Halbert teaches a second pump (other of elements 22, 24, 26, 28) and wherein the first pump (one of elements 22, 24, 26, 28) and the second pump are each associated with one of the at least two infusion or transfusion sets (sets formed by elements 30/31, 32/33, 34/35 and 36/37 associated with the selected first and second pump) for the purpose of using a well-known alternative approach to control the liquid flow from multiple containers (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the system of modified Archibald to incorporate a second pump and wherein the first pump and the second pump are each associated with one of the at least two infusion or transfusion sets as taught by Halbert for the purpose of using a well-known alternative approach to control the liquid flow from multiple containers (paragraph 0018).
Regarding claim 12, modified Archibald discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 9. Archibald further comprises a first pump 20 but is silent regarding a second pump wherein the system further comprises an infusion or transfusion set associated with the first pump and the second pump.
However, Halbert teaches a second pump (other of elements 22, 24, 26, 28) wherein the system further comprises an infusion or transfusion set (sets formed by elements 30/31, 32/33, 34/35 and 36/37 associated with the selected first and second pump) associated with the first pump (one of elements 22, 24, 26, 28) and the second pump (other of elements 22, 24, 26, 28) for the purpose of using a well-known alternative approach to control the liquid flow from multiple containers (paragraph 0018).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the system of modified Archibald to incorporate a second pump wherein the system further comprises an infusion or transfusion set associated with the first pump and the second pump as taught by Halbert for the purpose of using a well-known alternative approach to control the liquid flow from multiple containers (paragraph 0018).
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Archibald et al. (US 4,714,463) in view of Whitaker et al. (US 2016/0213862 A1) in view of Vanderveen et al. (US 2005/0145009 A1) and further in view of Kamen et al. (US 2013/0177455 A1).
Regarding claim 16, modified Archibald discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 4. Archibald is silent regarding the control device configured to determine, based on the measurement values acquired by the pressure measuring device, whether there is liquid on a side of the liquid-retaining filter membrane facing away from the pump.
However, Vanderveen discloses the controller device 75 configured to determine, based on the measurement values acquired by the pressure measuring device 225 (paragraph 0045, lines 1-7), whether there is liquid on a side facing away from the pump for the purpose of determining whether the container is empty (paragraph 0045, lines 1-7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the device of Archibald to incorporate the control device configured, to determine, based on the measurement values acquired by the pressure measuring device, whether there is liquid on a side facing away from the pump as taught by Vanderveen for the purpose of determining whether the container is empty (paragraph 0045, lines 1-7).
Additionally, examiner construes that Archibald modified in view of Whitaker and Vanderveen would result in a modified device having the control device configured to determine, based on the measurement values acquired by the pressure measuring device, whether there is liquid on a side of the liquid-retaining filter membrane facing away from the pump.
Modified Archibald is further silent regarding wherein the control device is configured to cause a pumping direction of the pump to be reversed.
However, Kamen teaches a design of a device for measuring the infusing fluid wherein the control device is configured to cause a pumping direction of the pump to be reversed (paragraph 1013, lines 20-23) for the purpose of removing air from the device (paragraph 1013, lines 20-23).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the device of modified Archibald to incorporate wherein the control device is configured to cause a pumping direction of the pump to be reversed as taught by Kamen for the purpose of removing air from the device (paragraph 1013, lines 20-23).
Conclusion
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/NILAY J SHAH/Primary Examiner, Art Unit 3783