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 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 1 is rejected under 35 U.S.C. 112 (b) for being indefinite since it is not clear if “preferably a density” is required in the claim. Correction/clarification is required.
All claims depending on claim 1 do not overcome the rejection of claim 1 under 35 U.S.C. 112 (b) for being indefinite, and therefore all claims depending on claim 1 are rejected under 35 U.S.C. 112 (b) for being indefinite.
Claim 2 is rejected under 35 U.S.C. 112 (b) for being indefinite since is not clear if “in particular a mixing operation carried out by it, is required by the claim. Correction/clarification is required.
Claim 4 is rejected under 35 U.S.C. 112 (b) for being indefinite since it is not clear if “with which the user is preferably requested to approve or instruct the prolongation of the mixing operation and/or to approve the mixture” is required by the claim. Correction/clarification is required.
Claim 8 is rejected under 35 U.S.C. 112 (b) for being indefinite since it is not clear if the limitations “preferably their time histories, preferably to file them in an electronic logbook” or “preferably a master display or a central database system” are required by the claim.
Claim 9 is rejected under 35 U.S.C. 112 (b) for being indefinite. It is not clear if “preferably carried out by means of a device according to any one of the preceding claims,” “preferably a density” or preferably by means of a measuring device associated with the device carrying out the mixing operation are required by the claim. Correction/clarification is required.
All claims depending on claim 9 do not overcome the rejection of claim 9 under 35 U.S.C. 112 (b) for being indefinite, and therefore all claims depending on claim 9 are rejected under 35 U.S.C. 112 (b) for being indefinite.
Claim 11 is rejected under 35 U.S.C. 112 (b) for being indefinite since it is not clear if “in particular a mixing operation carried out by said device” is required by the claim. Correction/clarification is required.
Claim 12 is rejected under 35 U.S.C. 112 (b) for being indefinite since it is not clear if “in particular for determining and/or scheduling times for repairs, the replacement of components and/or recalibrations” are required by the claim. Correction/clarification is required.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 3, 4, 5, 8, 9, 10, 11, and 12, are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Jansson (U.S. Publication 2019/0015800).
Regarding claim 1, Jansson teaches a device for preparing a medical solution by mixing at least one liquid and at least one concentrate raw material (figure 3, item 3 and 6, the materials are considered intended use), by means of or in a mixing container into which the at least one liquid and at least the one concentrate raw material can be fed (item 13 is considered reading on a mixing chamber), a control device (paragraph 56 feedback control), and a measuring device for measuring a parameter including a density of a mixture produced by means of the device during the mixing operation (item 12 is described as a concentration sensor, paragraph 48 teaches it may measure density), wherein the measuring device is configured to carry out measurements continuously and/or online during a mixing operation carried out by means of the device (paragraph 56 the sensor is used to maintained or a profiling curve is followed, paragraph 7 teaches an on-line preparation).
Regarding claim 2, Jansson teaches wherein the control device is configured to control or regulate the operation of the device (paragraph 56 feedback control), in particular a mixing operation carried out by it, on the basis of the parameter values generated by means of the measuring device and/ or on the basis of trend analyzes performed by it (paragraph 56 teaches the sensor is used to follow a profiling curve).
Regarding claim 3, Jansson teaches wherein the control device is configured to compare the parameter values measured by the measuring device with a setpoint value and, when the setpoint value or a tolerance range surrounding it is reached, to terminate a mixing operation carried out by means of the device and / or to issue an output to a user (paragraph 56 teaches the use of a profiling curve which is considered inherently comprising set points and a toleration range in order to obtain the desired mixed product).
Regarding claim 4, Jansson teaches wherein the control device is configured to operate the device for a first predetermined time span for carrying out a mixing operation (paragraph 49 teaches the feedback control is adjusted after a certain point in time) and, after elapse and/or during the predetermined first time span, to compare the parameter values measured by the measuring device preferably continuously and / or online, with a setpoint value (paragraph 48 teaches measuring density, paragraph 49 teaches on-line preparation) and, if the setpoint value or a tolerance range surrounding it is not reached, to prolong the mixing operation once or multiple times by a second predetermined time span to approve the mixture (paragraph 56 teaches a predetermined profiling curve for the concentration, the mixed material is delivered via dialysis once the desired concentration is reached).
Regarding claim 5, Jansson teaches wherein the control device is configured to discard a mixture produced by means of the device (paragraph 4 patient infused with the substitution solution is considered discarded by the mixing chamber 13) and/or to issue an output to a user that the produced mixture is to be discarded (paragraph 42 teaches the concentration can be adjusted by a nurse which would inherently include when the concentration is at the desired level to be sent to a patient), if a time course of the measured parameter values does not or not sufficiently approach or deviate from the setpoint value or the tolerance range during a predetermined time interval during the mixing operation (paragraph 42 teaches the result can be adjusted to obtain the desired level which inherently in a specific time).
Regarding claim 8, Jansson teaches wherein the control device is further configured to electronically document the parameter values determined by the means of the measuring device (paragraph 56 teaches using a predetermined profiling curve which inherently requires comparing the instant values to the desired values) as well as their time histories to transmit them to a master display (paragraph 42 teaches the concentration can be adjusted by a nurse which would inherently require a display).
Regarding claim 9, Jansson teaches a method for monitoring a mixing operation for preparing a medical solution (paragraph 1 teaches a medical fluid including water and a concentrate) by mixing at least one liquid (paragraph 1 teaches water) and a at least one concentrate material (paragraph 1 teaches a concentrate), wherein the mixing operation is carried out by means of a device according to any one of the preceding claims (figure 3 is considered a device for carrying out the mixing operation, see claim 1 rejection for the preceding claim), comprising the steps of measuring the density of a mixture (paragraph 48 teaches measuring density), produced by the means of the device during the mixing operation (the sensor 12 measures density during mixing in mixing chamber 13), including a measuring device associated with the device carrying out the mixing operation (item 12 sensor is considered reading on the measuring device).
Regarding claim 10, Jansson teaches wherein measuring the parameter is carried out continuously and/or online (paragraph 7 teaches on-line preparation).
Regarding claim 11, Jansson teaches further comprising the step of controlling or regulating the mixing operation carried out by the device on the basis of the parameter detected by means of the measuring device (paragraph 56 teaches a feedback control and detecting concentration to compare to a predetermined curve, paragraph 48 teaches that the sensor can be used to detect density).
Regarding claim 12, Jansson teaches using the parameter values detected by means of the measuring device in the context of a predictive maintenance of the device in particular recalibrations (paragraph 61 teaches rescaling the value of the sensor which is considered reading on recalibration).
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.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Jansson (U.S. Publication 2019/0015800) in view of Rechberger (“High Precision Vibration-Type Densitometers Based on Pulsed Excitation Measurements”).
Regarding claim 6, Jansson is silent the measuring device specifically being a flexural resonator. Regarding claim 6, Rechberger teaches the use of a flexural resonator sensor for measuring density (see abstract first two lines). Regarding claim 6, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the sensor of Jansson with the flexural resonator sensor of Rechberger in order to obtain a more accurate density reading during the mixing operation.
Regarding claim 7, Jansson is silent to the type of sensor. Regarding claim 7, Rechberger teaches a device for measuring density by means of ultrasound (glass flexural sensor which is considered capable of measuring ultrasound, see abstract lines 1-4). Regarding claim 7, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the sensor of Jansson with the flexural resonator sensor of Rechberger in order to obtain a more accurate density reading during the mixing operation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANSHU BHATIA whose telephone number is (571)270-7628. The examiner can normally be reached Monday - Friday 11 a.m. to 7:30 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, Claire Wang can be reached at (571)270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANSHU BHATIA/Primary Examiner, Art Unit 1774