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 .
Response to Amendment
The amendment filed 10/24/2024 has been entered: Claims 17-39 are new and remain pending in the present application. Claims 1-16 have been canceled. Claims 17-39 are examined on the merits.
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 17-39 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “prominent” in claims 17 and 33 is ordinarily defined as “readily noticeable.” However, Applicant’s specification refers to the term prominent as “e.g. maximum, minimum, average, etc.,” on Page 3, line 12. The term is indefinite because the specification does not clearly redefine the term as only examples are provided. Further, it is unclear what is encompassed by “etc.” As such, the metes and bounds of the term “prominent” cannot be determined.
In an effort to promote compact prosecution, the limitation is interpreted as comprising a maximum, minimum, or average temperature value.
Claim 17 recites the limitation "the temperature of the treatment liquid" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claims 18-32 are rejected via their dependency on claim 17. Claims 34-39 are rejected via their dependency on claim 33.
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.
Claim(s) 17-24, and 26-39 are rejected under 35 U.S.C. 103 as being unpatentable over Pouchoulin (US 2019/0160216 A1, cited in Applicant’s IDS), in view of Wikipedia (Moving average, captured 2020 by Wayback Machine).
Regarding claim 17, Pouchoulin teaches a blood treatment apparatus (Fig. 1; Abstract) comprising:
a fluid line (dialysis line 16),
a pump configured to convey treatment liquid through the fluid line (¶ 118 describes how dialysis line 16 comprises a dialysis pump; also recirculation pump 17 which is un fluid line 10),
a heating device configured to heat the treatment liquid within the fluid line (warming device 13; ¶ 115), temperature
a temperature measuring device configured to measure the temperature of the treatment liquid using at least one temperature sensor when the treatment liquid is present in the fluid line (temperature sensor 24, also 22; ¶s 123-124),
a storage device configured for storing amounts of temperature values (¶ 123 describes control unit with memory; ¶s 20 and 128 describes how blood temperature values are stored in the control device), and
a control device configured for controlling the pump configured for conveying treatment fluid (¶s 125-129 describes the control unit controlling the flow rate of dialysis fluid through dialysis line 16 and control over recirculation pump 17),
wherein the control device is programmed to:
prompt the temperature measuring device to measure a temperature value (¶s 61 and 130-134);
store the temperature value, thus determined, in the storage device (¶s 20 and 128);
read out the stored, determined temperature values from the storage device (¶s 125-130 describe how the control unit responds to the measured temperature values, which would require reading said temperature values),
read out, from the storage device, a predetermined absolute value of the temperature which the treatment liquid at a predetermined site within the fluid line downstream of the heating device can amount to a maximum value (¶s 61 and 132-138 describe how a maximum temperature is set); and
determine the conveyance rate of the pump such that the treatment liquid already present downstream of the heating device in the fluid line, the determined temperature values of which have been read out from the storage device, reaches the predetermined site having a temperature lower than or equal to the maximum value (¶s 128 and 132-138 describe how the pump rate is also modulated to control temperature and that cooling is anticipated after the fluid leaves the heating device).
Pouchoulin does not explicitly teach measuring a plurality of temperature values at a respective plurality of measurement times which are associated with different measurement intervals, and to determine, for each of the measurement intervals, a maximum, minimum, or average temperature value from the temperature values measured during the respective measurement interval.
In addressing the same problem as Applicant, the problem being the measurement and analysis of data, Wikipedia teaches measuring a plurality of values at a respective plurality of measurement times which are associated with different measurement intervals, and to determine, for each of the measurement intervals, an average value from the values measured during the respective measurement interval (see Simple moving average or Cumulative average).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Pouchoulin to measure temperature values using a moving average, as taught by Wikipedia. Doing so would thus comprise measuring a plurality of temperature values at a respective plurality of measurement times which are associated with different measurement intervals, and determining, for each of the measurement intervals, an average temperature value from the temperature values measured during the respective measurement interval. Doing so would be advantageous in providing data smoothing (first paragraph of Wikipedia) which can help account for outlying or erroneous data measurements.
Regarding claim 18, Pouchoulin further teaches the pump is a substitute fluid pump (both pump 17 and the unshown dialysis pump would both move substitute fluid and thus are interpreted as substitute fluid pumps; ¶s 117-118).
Regarding claim 19, Pouchoulin teaches the pump for conveying the treatment liquid is a dialysis liquid pump (both pump 17 and the unshown dialysis pump would both move dialysis liquid and thus are interpreted as dialysis fluid pumps; ¶s 117-118) arranged to convey the treatment liquid as dialysis liquid into a dialysis liquid chamber of a blood filter comprising the dialysis liquid chamber and a blood chamber, separated therefrom via a membrane (blood chamber 3 with fluid chamber 4 and membrane 5; ¶s 117-121).
Regarding claim 20, Pouchoulin teaches the predetermined site is the dialysis liquid chamber (fluid chamber 4; ¶s 117-121).
Regarding claim 21, Pouchoulin further teaches the predetermined site is in addition site for treatment liquid, as a substitute fluid, into an extracorporeal circuit (¶ 122 describes infusion lines for a replacement fluid in pre-infusion line 19 and post-infusion line 20, post-infusion line 20 being adjacent to temperature sensor 22).
Regarding claim 22, Wikipedia further teaches the length of time measurement intervals is constant (under Simple moving average, using one point per day).
As previously stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Pouchoulin to measure temperature values using a moving average, as taught by Wikipedia. Doing so would thus comprise having the time length of measurement intervals be constant and to be stored in the storage device (as performing computer operations requires storage in memory). Doing so would be advantageous in providing data smoothing (first paragraph of Wikipedia) which can help account for outlying or erroneous data measurements.
Regarding claim 23, Pouchoulin further teaches the amounts of treatment liquid conveyed in each of the measurement intervals is stored (¶s 129-134 describe how the controller provides fixed flow rate amounts in ml/min, which would necessarily be stored in the controller’s memory).
Regarding claim 24, Pouchoulin further teaches the amounts of treatment liquid conveyed in each of the measurement intervals is stored (¶s 129-134 describe how the controller provides fixed flow rate amounts in ml/min, which would necessarily be stored in the controller’s memory) and are stored together with the respective temperature value and a designation for identifying the associated measurement interval corresponding to the respective determined temperature (¶s 128 and 132-138 describe how the pump rate is also modulated to control temperature based on a set temperature maximum, thus the controller uses temperature and the amount of treatment liquid conveyed, via the conveyance flow rate, together, and said parameters must be stored and identified together in memory).
Regarding claim 26, Pouchoulin further teaches the control device is programmed to control a conveyance rate of the pump for conveying treatment liquid such that the temperature of the treatment liquid being conveyed by the pump to the predetermined sites that exceed a predetermined temperature value(¶s 128 and 132-138 describe how the controller controls the pump rate in order to keep the temperature below a maximum temperature value).
Regarding claim 27, Pouchoulin further teaches the control device is programmed to adjust the determined temperature values downward by a correction value for periods of time during which the pump is not conveying (¶s 128 and 132-138 describe how the controller controls the pump rate in order to keep the temperature below a maximum temperature value, including when the pump flowrate, Qd, is 0 i.e. when the pump is not conveying).
Regarding claim 28, Pouchoulin further teaches the control device is programmed to correct or adjust the determined temperature values after storing the determined temperature values (¶s 128 and 132-138 describe how the controller controls the pump rate in order to keep the temperature below a maximum temperature value, which would necessarily require storing the temperature values to memory in order for the temperature values to be accessed by the controller).
Regarding claim 29, Pouchoulin further teaches comprising a blood pump (blood pump 8).
Regarding claim 30, Pouchoulin further teaches the control device programmed to determine a cooling of the treatment liquid during passage of the treatment liquid towards the predetermined site (¶s 91 and 134).
Regarding claim 31, Pouchoulin further teaches the determining of the cooling of the treatment liquid comprises determining the cooling of the treatment liquid during the passage of the treatment liquid between the temperature measuring device and the predetermined site (¶ 137).
Regarding claim 32, Pouchoulin further teaches the cooling of the treatment liquid during passage between the temperature measuring device and the predetermined site is determined by calculation (¶ 137 indicates the temperature is preset based on anticipated cooling).
Regarding claim 33, Pouchoulin teaches a blood treatment apparatus (Fig. 1; Abstract) comprising:
a control device configured for controlling or regulating the pump configured for conveying treatment fluid (¶s 125-129 describes the control unit controlling the flow rate of dialysis fluid through dialysis line 16 and control over recirculation pump 17),
wherein the control device is programmed to:
prompt a temperature measuring device to measure a temperature value (¶s 61 and 130-134);
store the temperature value, thus determined, in a storage device (¶s 20 and 128);
read out the stored, determined temperature values from the storage device (¶s 125-130 describe how the control unit responds to the measured temperature values, which would require reading said temperature values),
read out, from the storage device, a predetermined absolute value of a temperature which a treatment liquid at a predetermined site within a fluid line downstream of a heating device can amount to a maximum value (¶s 61 and 132-138 describe how a maximum temperature is set); and
determine the conveyance rate of the pump such that the treatment liquid already present downstream of the heating device in the fluid line, the determined temperature values of which have been read out from the storage device, reaches the predetermined site having a temperature lower than or equal to the maximum value (¶s 128 and 132-138 describe how the pump rate is also modulated to control temperature and that cooling is anticipated after the fluid leaves the heating device).
Pouchoulin does not explicitly teach measuring a temperature value at a respective plurality of measurement times which are associated with different measurement intervals, and to respectively determine, for each of the measurement intervals, a maximum, minimum, or average temperature value from the temperature values measured during the respective measurement interval.
In addressing the same problem as Applicant, the problem being the measurement and analysis of data, Wikipedia teaches measuring a plurality of values at a respective plurality of measurement times which are associated with different measurement intervals, and to determine, for each of the measurement intervals, an average value from the values measured during the respective measurement interval (see Simple moving average or Cumulative average).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Pouchoulin to measure temperature values using a moving average, as taught by Wikipedia. Doing so would thus comprise measuring a plurality of temperature values at a respective plurality of measurement times which are associated with different measurement intervals, and determining, for each of the measurement intervals, an average temperature value from the temperature values measured during the respective measurement interval. Doing so would be advantageous in providing data smoothing (first paragraph of Wikipedia) which can help account for outlying or erroneous data measurements.
Regarding claim 34, the combination of Pouchoulin and Wikipedia substantially disclose the invention of claim 17. Pouchoulin further discloses a digital storage medium with electronically readable control signals, configured to interact with a programmable computer system such that a blood treatment apparatus is programmed into the blood treatment apparatus of claim 17 (¶ 123 describes control unit with memory; ¶s 132-138 further describe how the memory and computer system are used to read and write data for the control of the device of claim 17; in addition, programming is necessary for the computerized functions of Pouchoulin).
Regarding claim 35, the combination of Pouchoulin and Wikipedia substantially disclose the invention of claim 33. Pouchoulin further discloses a digital storage medium with electronically readable control signals, configured to interact with a programmable computer system such that a blood treatment apparatus is programmed to the control device of claim 33 (¶ 123 describes control unit with memory; ¶s 132-138 further describe how the memory and computer system are used to read and write data for the control of the device of claim 33; in addition, programming is necessary for the computerized functions of Pouchoulin).
Regarding claim 36, the combination of Pouchoulin and Wikipedia substantially disclose the invention of claim 17. Pouchoulin further discloses a computer program product configured to interact with a programmable computer system such that a blood treatment apparatus is programmed into the blood treatment apparatus according to claim 17 (¶ 123 describes control unit with memory; ¶s 132-138 further describe how the memory and computer system are used to read and write data for the control of the device of claim 17; in addition, programming is necessary for the computerized functions of Pouchoulin).
Regarding claim 37, the combination of Pouchoulin and Wikipedia substantially disclose the invention of claim 33. Pouchoulin further discloses a computer program product configured to interact with a programmable computer system such that a control device is programmed into the control device of claim 33 (¶ 123 describes control unit with memory; ¶s 132-138 further describe how the memory and computer system are used to read and write data for the control of the device of claim 33; in addition, programming is necessary for the computerized functions of Pouchoulin).
Regarding claim 38, the combination of Pouchoulin and Wikipedia substantially disclose the invention of claim 17. Pouchoulin further discloses a computer program having a program code for prompting the programming of a blood treatment apparatus such that it is programmed into the blood treatment apparatus according to claim 17 (¶ 123 describes control unit with memory; ¶s 132-138 further describe how the memory and computer system are used to read and write data for the control of the device of claim 17; in addition, programming is necessary for the computerized functions of Pouchoulin).
Regarding claim 39, the combination of Pouchoulin and Wikipedia substantially disclose the invention of claim 33. Pouchoulin further discloses a computer program having a program code for prompting the programming of a control device that is programmed into the control device according to claim 33 (¶ 123 describes control unit with memory; ¶s 132-138 further describe how the memory and computer system are used to read and write data for the control of the device of claim 33; in addition, programming is necessary for the computerized functions of Pouchoulin).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Pouchoulin and Wikipedia as applied to claim 17 above, and further in view of Wikipedia (Circular buffer, captured 2020 by Wayback Machine), hereinafter Wikipedia 2.
Regarding claim 25, the combination of Pouchoulin and Wikipedia do not explicitly teach the storage device comprises a ring buffer or ring memory in which the determined temperature values are stored.
In addressing the same problem as Applicant, the problem being the storage of data, Wikipedia 2 teaches the use of a ring buffer data structure for data storage (under Overview and Uses).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Pouchoulin and Wikipedia to explicitly use a ring buffer as their memory storage device. Doing so would thus comprise the storage device comprises a ring buffer or ring memory in which the determined temperature values are stored. Doing so would be advantageous as such an arrangement can be more efficient (see Optimization in Wikipedia 2).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALESSANDRO R DEL PRIORE whose telephone number is (571)272-9902. The examiner can normally be reached Monday - Friday, 8:00 - 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALESSANDRO R DEL PRIORE/ Examiner, Art Unit 3781
/GUY K TOWNSEND/ Primary Examiner, Art Unit 3781
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