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
Claim 1 is objected to because of the following informalities: “predefine” should be “predefined.” Appropriate correction is required.
Claims 2 and 3 are objected to because of the following informalities: “dependant” should be “dependent.” 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 1-9 and 11-12 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 claims 1, 11, and 12, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 10, 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spickermann et al. (US 20190143025 A1).
Regarding claim 10, Spickermann discloses an apparatus for blood vessel needle dislodgement detection, comprising;
a blood analysis loop (2, fig. 3); and
a processor configured to control the blood analysis loop and detect a potential blood vessel needle dislodgement (para. [0048]);
wherein the blood analysis loop is configured to carrying out a blood treatment and/or an analysis on a patient (para. [0061]);
wherein the blood analysis loop comprises a blood pump (6), a blood line pressure sensor (7) and a blood line clamp (9, para. [0064-0064, 0066]);
wherein the blood line pressure sensor is configured to record blood line pressure datasets of the blood of the patient and to transmit the recorded blood line pressure datasets to the processor (para. [0064, 0066]);
wherein the processor is further configured to confirm or disprove the potential blood vessel needle dislodgement and, based on a confirming or disproving a potential blood vessel dislodgement detection, to operate the blood line clamp and/or the blood pump (para. [0043, 0077]).
Regarding claim 13, Spickermann discloses the apparatus of claim 10 and further discloses wherein the processor is further configured to stop the blood pump of the blood analysis loop, keep open the blood line clamp and instruct the blood line pressure sensor to carry out a static blood vessel pressure measure such as to confirm or disprove the potential blood vessel needle dislodgement (par. [0072]).
Regarding claim 14, Spickermann discloses the apparatus of claim 10 and further discloses wherein the processor is communicatively connected with the blood analysis loop (para. [0015]).
Regarding claim 15, Spickermann discloses the apparatus of claim 10 and further discloses wherein the processor is further configured to trigger an alarm when the potential blood vessel needle dislodgement is confirmed (para. [0042]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 5, and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spickermann et al. (US 20190143025 A1) in view of Wabel et al. (US 20150164370 A1) and Sands et al. (US 20130211206 A1).
Regarding claim 1, Spickermann discloses a method for blood vessel dislodgement detection, comprising the following steps:
carrying out a blood treatment and/or an analysis on a patient using a blood analysis loop at a predefined blood flow (para. [0015, 0060]);
recording at predefined time intervals blood line pressure datasets using a blood line pressure sensor (7) of the blood analysis loop (para. [0043, 0066]);
detecting a potential blood vessel dislodgement based on a detecting function λ (para. [0043]);
confirming or disproving the potential blood vessel needle dislodgment by a static blood line pressure measure performed by stopping the blood flow and keeping a blood line of the blood analysis loop not isolated from the patient blood vessel (para. [0072])
wherein detecting a potential blood vessel needle dislodgement comprises a comparison between the detecting function λ and a predefined threshold B (para. [0048]).
However, Spickermann fails to disclose filtering the recorded blood line pressure datasets using a predefined filter function, in particular a Kalman filter.
Wabel teaches a measurement device for dialysis that filters data via a Kalman filter (para. [0046]).
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 method of Spickermann and incorporate the filtering as used in Wabel to reduce noise from the detected measurements. Furthermore, Spickermann already teaches filtering data with a function (para. [0044, 0067]), so incorporating a specific filter function would yield predictable results namely, a dataset with reduced noise.
However, Spickermann and Wabel fail to disclose testing the filtered blood line pressure datasets using the processor, which is configured to test the filtered blood line pressure datasets based on a test function, in particular the Wald test.
Sands teaches a patient monitoring system that tests their pressure readings against a chi-squared test threshold (para. [0107]).
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 method of Spickermann and incorporate the testing as used in Sands to determine a statistically significant deviation from a designated threshold value. Furthermore, Spickermann already teaches testing a pressure value to a reference value (para. [0015]), so incorporating a statistical test to determine significance would yield predictable results namely, a verification of a significant pressure change.
Regarding claim 5, the combination of Spickermann, Wabel, and Sands discloses the method of claim 1. Spickermann further discloses comprising the following step: in case the potential blood vessel needle dislodgement is confirmed, the blood analysis loop remains stopped and/or an alarm is triggered (para. [0042]).
Regarding claim 8, the combination of Spickermann, Wabel, and Sands discloses the method of claim 1. Spickermann further discloses wherein the blood flow is constant during each predefined time intervals (para. [0009, 0025, 0043]); and wherein the blood flow is controlled using a blood pump of the blood analysis loop (para. [0062, 0064]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spickermann et al. (US 20190143025 A1) in view of Wabel et al. (US 20150164370 A1).
Regarding claim 11, Spickermann discloses the apparatus of claim 10, but fails to disclose wherein the processor is further configured to filter the recorded blood line pressure datasets using a predefined filter function, in particular a Kalman filter.
Wabel teaches a measurement device for dialysis that filters data via a Kalman filter (para. [0046]).
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 method of Spickermann and incorporate the filtering as used in Wabel to reduce noise from the detected measurements. Furthermore, Spickermann already teaches filtering data with a function (para. [0044, 0067]), so incorporating a specific filter function would yield predictable results namely, a dataset with reduced noise.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spickermann et al. (US 20190143025 A1) in view of Sands et al. (US 20130211206 A1).
Regarding claim 12, Spickermann discloses the apparatus of claim 10, but fails to disclose wherein the processor is further configured to test the difference between a recorded blood line pressure data set and a filtered blood line pressure dataset based on a test function, in particular the Wald test.
Sands teaches a patient monitoring system that tests their pressure readings against a chi-squared test threshold (para. [0107]).
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 method of Spickermann and incorporate the testing as used in Sands to determine a statistically significant deviation from a designated threshold value. Furthermore, Spickermann already teaches filtering data with a function (para. [0044, 0067]) and testing said pressure to a reference value (para. [0015]), so incorporating a statistical test to determine significance would yield predictable results namely, a verification of a significant pressure change.
Allowable Subject Matter
Claims 2-4, 6-7, and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form and to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: there is no art alone or in combination with the found prior art that discloses these limitations: initializing the filter function wherein it is based on a statistical parameter that is dependent on the blood analysis loop, automatically restarting the blood flow if the dislodgement is disproved, detection and alarm probabilities, and time dependent difference functions.
Spickermann teaches a basic needle dislodgement detection system using a detecting function, and Wabel and Sands are incorporated to apply more functions for refining the method. No prior art could be found within the needle dislodgement technology nor the broader art of extracorporeal system that would have been reasonable to combine with those references without relying in hindsight. Such detailed limitations would be adding processes and functionality beyond what Spickermann, Wabel, or Sands teaches and would not have been obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN A KIM whose telephone number is (703)756-4738. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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/ERIN A KIM/Examiner, Art Unit 3781
/SUSAN S SU/Primary Examiner, Art Unit 3781 22 July 2026
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