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 .
Claim Objections
Claims 1-10 are objected to because of the following informalities:
Reference numbers for elements shown in the figures of the instant specification are shown throughout all of the claims. Examiner recommends removing these reference numbers within the claims.
Claim 1 recites “the fluid outlet” before “a fluid outlet”. While the claim is eventually clear with respect to the structure of the fluid outlet, examiner recommends placing antecedent basis at the first mention of the fluid outlet.
Claim 2 recites a data input interface making data available to a control or regulating device, and further recites “at least one control or regulating device”. The control or regulating device already has antecedent basis and as such the second instance should refer to the at least one control or regulating device.
Moreover, claim 2 recites “flow rate required at the fluid outlet” followed by “at least one fluid outlet”. Claim 1 already recites the at least one fluid outlet, which is noted to be the same element as they are noted with the same element number (8). Examiner recommends amending the claim for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 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 1 recites that the mixing apparatus is “in particular for dialysis or infusion treatments”, wherein “in particular” makes the limitation unclear as to if the device is meant for dialysis or infusion treatment. For the purpose of examination, the examiner will assume the device is required for use for dialysis or infusion treatments.
Claim 2 recites a common liquid line system which “may” comprise a liquid reservoir and the fluid outlet “may likewise comprise a dosing apparatus”. The limitation that the reservoir “may” be in the invention makes the metes and bounds of the limitation unclear as to whether or not the structure is part of the claimed invention. For the purpose of examination, the noted structures will be assumed to be part of the limitation.
Moreover, claim 2 recites the data input interface making data available to the apparatus, “and in particular to a control or regulating device”. “In particular” similarly makes the claim indefinite since the phrase doesn’t make it clear as to whether the limitation is required. For the purpose of examination, examiner will assume the limitation is required.
The remaining claims are rejected by virtue of being dependent on claim 1.
Claims 3, 6, and 9-10 are rejected by virtue of being dependent on claim 2.
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 6 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. Claim 6 recites wherein the common liquid line system contains a reservoir, a limitation already claimed in claim 2. As such, the reservoir does not further limit the claim. 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 1-2 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fichert (DE 102013102914) in view of Israel (US 4668219). References to Fichert will be pointing to the machine translation provided.
Regarding claim 1, Fichert discloses a mixing apparatus for producing solutions to be administered to humans for dialysis or infusion treatments (abstract), having:
At least two fluid inlets (fig. 1, fluid inlet for each reservoir 5-10. The inlets can also be interpreted as the inlet for reservoir 5 and for pump 3 to provide water), to which base solutions are connected (fig. 1 demonstrates a reservoir 5-10 and a source of water containing base solutions. NOTE: “base solution” as interpreted from the applicant’s instant invention is a starting formulation and not necessarily a solution with a basic pH, see instant spec, paragraph 0024),
a mixing device, which quantitatively mixes the base solutions connected to the fluid inlets in such a way that the mixed solution at the fluid outlet has the required volume or mass flow rate and corresponds in its substance composition to the required substance composition (fig. 2, mixing chamber 18 comprising a magnetic stirrer as the mixing device for mixing the differing solutions and exits at exit 19. The mixture of these substances plus water give the required substance composition, and the exit 19 provides a required volume/mass flow rate. It is noted while fig. 2 shows another embodiment, the mixing device 1 in fig. 2 corresponds essentially to the structure according to fig. 1, pg. 8, paragraph 6);
at least one fluid outlet (19), at which the substance composition of the finally mixed solution lies within the composition intervals defined by the base solutions connected to the fluid inlets (fig. 2, exit 19 as a fluid outlet of the mixer 18).
Fichert does not teach wherein the base solutions are within predefined concentration limits and differ from one another only in the substance quantities of the substances to be varied at the fluid outlet.
However, Fichert teaches wherein, for instance the solution in the first reservoir is diluted with water (page 4, paragraph 2, “At least one pure water inlet”). Israel, on the other hand, teaches a means for mixing solutions (abstract) that utilizes a first concentration of dextrose and lidocaine as a diluent, and a second solution with a different concentration of dextrose and lidocaine (col. 6, lines 38-41 and 57-68), thus suggesting that mixing two solutions of predefined limits/concentrations is a suitable means of forming a solution versus diluting a concentrate with water.
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 in Fichert such that at least two fluid inlets are connected to base solutions, wherein the base solutions (in this instance for substance in reservoir 5 and water) are within predefined concentration limits and differ from one another only in the substance quantities of the substances to be varied at the fluid outlet, as taught by Israel, since Israel appears to treat a diluting solution with drug and without drug to be equivalents in the art (col. 6, lines 38-41 describes adding drug into the IV bag to dorm a dilute solution of the drug if desired), and one of ordinary skill in the art would have found it obvious to substitute one known equivalent for another.
Regarding claim 2, Fichert discloses a number ni=2ns of fluid inlets for the variation of a number of substances contained in a solution mixed therefrom to be administered to humans (fig. 1 shows one substance from reservoir 5, with an inlet from reservoir 5 and a source of water to vary the concentration of the substance from reservoir 5, ni=1 in this instance, with 2 fluid inlets),
wherein each fluid inlet respectively has at least one dosing apparatus (3, 11), the dosing apparatuses being in fluid connection with a common liquid line system (fig. 1, pumps 3 and 11 serving as dosing apparatuses in line with the media transport device 4)
at least one common liquid line system (fig. 1 shows a common media transport device 4 as a common liquid line) which comprises a liquid reservoir (fig. 2, mixer 18 interpreted as the reservoir, whereas best understood by examiner the reservoir is part of the mixing device)
at least one data input interface which can receive data from the user and make the data available to a control or regulation device (page 4, paragraph 2, “A data interface for the transmission of patient data for the individual composition of the dialysis solution required for carrying out a blood purification process; - At least one control device that controls the individual flow control devices of the reservoir and regulates the delivery of the respective components contained in the reservoirs such that each component is quantitatively added according to the transmitted patient data of the media transport device”)
at least one control or regulating device which controls or regulates the dosing apparatus in such a way that each base solution connected to the fluid inlet is quantitatively admixed with the common liquid line system so that the solution for dialysis or infusion treatments as the volume or mass flow rate required at the fluid outlet and corresponds in its substance composition to the substance composition defined by the data input interface (page 4, paragraph 2, “at least one control device that controls the individual flow control devices of the reservoir and regulates the delivery of the respective components contained in the reservoirs such that each component is quantitatively added according to the transmitted patient data of the media transport device”)
the at least one fluid outlet for the finally mixed solution to be administered to humans, which may likewise comprise a dosing apparatus (fig. 1 shows an outlet at the end of element 4, with pump 17 as a dosing apparatus. Page 8, paragraph 5 notes that an additional reservoir with basic bicarbonate concentrate is added to line 4 for the end result to be a ready-to-use dialysis solution, which is interpreted as being utilized for being administered to humans).
but does not teach wherein these fluid from the fluid inlets differ from one another only in the substance quantities of the substances to be varied at the fluid outlet.
However, Fichert teaches wherein, for instance the solution in the first reservoir is diluted with water (page 4, paragraph 2 “At least one pure water inlet”). Israel, on the other hand, teaches a means for mixing solutions (abstract) that utilizes a first concentration of dextrose and lidocaine as a diluent, and a second solution with a different concentration of dextrose and lidocaine (col. 6, lines 38-41 and 57-68), thus suggesting that mixing two solutions of predefined limits/concentrations is a suitable means of forming a solution versus diluting a concentrate with water.
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 in Fichert such that at least two fluid inlets are connected to base solutions, wherein the base solutions (in this instance for substance in reservoir 5 and water) are within predefined concentration limits and differ from one another only in the substance quantities of the substances to be varied at the fluid outlet, as taught by Israel, since Israel appears to treat a diluting solution with drug and without drug to be equivalents in the art (col. 6, lines 38-41 describes adding drug into the IV bag to dorm a dilute solution of the drug if desired), and one of ordinary skill in the art would have found it obvious to substitute one known equivalent for another.
Regarding claim 4, Fichert discloses the mixing apparatus which is configured as an integral constituent of a blood treatment unit (page 6, paragraph 4, “A preferred embodiment of the present invention is that the mixing device is formed as an integral part of a dialysis system”).
Regarding claim 5, Fichert discloses the mixing apparatus which is located outside a blood treatment unit and is connected thereto (page 6, paragraph 5“the device according to the invention can also be designed as an additional module for a dialysis system. Such an additional module can easily be submerged in the tube system of an existing dialysis machine”).
Regarding claim 6, Fichert discloses wherein the common liquid line system contains a reservoir (fig. 2, mixing chamber 18 as the reservoir, page 8, paragraph 7 “part of the line 4 out 1 is as a mixing chamber 18”)
Regarding claim 7, Fichert does not teach wherein the device has four inputs for mutually independent variation of the concentration of two substances at the fluid outlet of the mixing apparatus.
However, Fichert discloses two inputs for variation of the concentration of one substance (fig. 1 shows reservoir 5 and water inlet from pump 3 as two inputs to vary the concentration of material in reservoir 5). Moreover, if Israel suggests using a diluted version of a drug to dilute a concentrate of the same drug (col. 6, lines 38-41 and 57-68), then one of ordinary skill in the art would appreciate that a second drug would be diluted with a diluted version of the second drug.
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 in Fichert such that the device has four inputs for mutually independent variation of the concentration of two substances at the fluid outlet of the mixing apparatus (i.e., a concentrate plus a diluting input for one substance, and a concentrate plus a diluting input for another substance), as suggested by Israel, for the purpose of providing a suitable structure that grants a matching diluted solution with each concentrate required.
Regarding claim 8, Fichert discloses wherein the device has two inputs for variation of the concentration of one substance at the fluid outlet of the mixing apparatus (fig. 1 shows reservoir 5 and water inlet from pump 3 as two inputs to vary the concentration of material in reservoir 5).
Regarding claim 9, Fichert discloses wherein the dosing apparatus is configured as a pump or valve (fig. 1 shows flow control devices 11-16 as pumps)
Regarding claim 10, Fichert discloses wherein the control or regulating unit is configured as a programmable processor (page 6, paragraph 3, “A preferred embodiment of the present invention is that the controller is a programmable processor”).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Fichert in view of Israel, and further in view of Gotch (US 20080296226).
Regarding claim 3, Fichert discloses the mixing apparatus which comprises at least one sensor device which measures at least one physical quantity (page 6, paragraph 7 “It is further preferred that sensor devices for quality control of the dialysis solution are provided at the outlet of the media transport device”), but is silent to wherein the device makes this measurement result available to the control or regulating device.
However, Gotch teaches wherein conductivity detectors are providing signals to a control unit (paragraph 0055), and based on the input, control the amount of fluid transported to the mixer (paragraph 0055).
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 in Fichert such that it comprises at least one sensor device which measures at least one physical quantity and makes the measurement result available to the control device, as taught by Gotch, for the purpose of providing a suitable structure that can control proportions of the relevant solutions after initial mixing (see Gotch, paragraph 0055).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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/Brandon W. Levy/Examiner, Art Unit 3781