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 title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 1 and 8 are objected to because of the following informalities: in line 2 of claim 1 and in line 3 of claim 8, the limitation “the optical measurement” should be “an optical measurement” for antecedent purposes. 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.
Claim 14 is 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.
In regards to claim 14, the use of the limitation “it” in line 2 of the claim is unclear. What does “it” mean in the context of the claim? Is it the reference values, optical measurement, the change in amplitude and/or shifts of phase, quantity of air? For Examining purposes the “it” some value of changes in amplitude and/or shifts of phase relative to reference values with presence and quantity of air in the cuvette. Please clarify.
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.
Claim(s) 1, 3, 8, 10 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loderer et al. (US 20180110913) in view of Padmanabhan et al. (US 20070166195) and Jasperse et al. (US 20250319466).
Re claims 1 and 8: Loderer teaches an in-vitro diagnostic (IVD) analyzer and automated method (fig. 5, 6, 9, 12 and 13) comprising an optical detection unit (615/613/612/614/616) comprising a cuvette (T) for the optical measurement of a biological sample (paragraph 27 and 61) contained therein, the IVD analyzer (fig. 13 and 6) further comprising a piezo actuator (27/31) (paragraph 40 and 43) arranged on one side of the cuvette (see fig. 6) configured to transmit ultrasonic waves (paragraph 40 and 43) through the cuvette (T) (see fig. 6), a piezo receiver (29/33) arranged on the opposite side of the cuvette (T) configured to receive ultrasonic waves (paragraph 40 and 43) transmitted through the cuvette (T) (fig. 6) and a controller (21/430) configured to operate according to either a flow rate operating mode or an air-detection operating mode (paragraphs 51 and 52, fig. 5, 9 and 12, operates in two modes, bubble/air detection and flow rate detection), and wherein according to the air-detection operating mode (bubble/air detection mode, paragraph 51 and 52) the piezo actuator (27/31) is configured to transmit ultrasonic waves through the cuvette (T) (paragraphs 40, 43, 51 and 52) and the controller (430/21) is configured to correlate changes in amplitude and/or shifts of phase of the ultrasonic waves received by the piezo receiver (29/33) relative to reference values with an eventual presence and quantity of air (bubble/air) in the cuvette (T) (paragraphs 43-45 and 59-63, fig. 5, 9, 12 and 13), but does not specifically teach configured to operate according to either a lysis operating mode, wherein according to the lysis operating mode the piezo actuator is configured to transmit ultrasonic waves through the cuvette for disrupting cellular particles contained in the biological sample and determine if the optical measurement of the biological sample is affected by the presence of air. Padmanabhan teaches a controller (40) is configured to correlate changes in amplitude and/or shifts of phase of the ultrasonic waves (paragraphs 158 and 159) received by a receiver (828) relative to reference values with an eventual presence and quantity of air in a cuvette (fig. 18), in order to determine if an optical measurement of a biological sample is affected by the presence of air (paragraph 73 and 159). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to determine if the optical measurement is affected by the presence of air/bubbles similar to Padmanabhan with the analyzer of Loderer in order to ensure the optical measurement is just the lysed sample or sample without bubbles providing an output with reduced error caused by the bubble/air. Loderer as modified by Padmanabhan does not specifically teach configured to operate according to either a lysis operating mode, wherein according to the lysis operating mode the piezo actuator is configured to transmit ultrasonic waves through the cuvette for disrupting cellular particles contained in the biological sample. Jasperse teaches an in-vitro diagnostic (IVD) analyzer (fig. 11 and 13) comprising an optical detection unit (112/114) comprising a cuvette (22/12) for the optical measurement of a biological sample (paragraph 97 and 98) contained therein, the IVD analyzer (fig. 11 and 13) further comprising a piezo actuator (14) arranged on one side of the cuvette (22) configured to transmit ultrasonic waves through the cuvette (22) (paragraph 100) and a controller (106) configured to operate according to either a lysis operating mode (216/218) or a plasma anti-node operating mode (210/212), wherein according to the lysis operating mode (216/218) the piezo actuator (14) is configured to transmit ultrasonic waves through the cuvette (214) for disrupting cellular particles contained in the biological sample (paragraph 216) (fig. 11 and 13). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to further include a lyse operation mode similar to Jasperse with the piezo actuator of Loderer in order to use the piezo actuator in a mode for a lyse operation for determining hemoglobin with the optical sensor and detect bubble/air disturbances in an air detection mode in the channel reducing the number of transducers in the analyzer providing for a more compact analyzer compensating for unwanted air/bubbles in the optical measurements.
Re claims 3 and 10: Loderer as modified by Padmanabhan and Jasperse teaches the IVD analyzer and method, wherein the ultrasonic waves transmitted by the piezo actuator (Loderer, 27/31, Jasperse, 14) according to the air detection operating mode have different amplitude and/or frequency with respect to the ultrasonic waves transmitted according to the lysis operating mode (Jasperse, paragraphs 146 and 147, Loderer, paragraphs 40 and 43, different frequencies).
Re claim 14: Loderer as modified by Padmanabhan and Jasperse teaches comprising performing the optical measurement of the biological system if it is determined that the optical measurement is unaffected by the presence of air (Padmanabhan, paragraph 73 and 159, fig. 18, when air is present the analyzer is shut down, the optical measurement is performed when no air is present).
Claim(s) 2 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Loderer et al. (US 20180110913) as modified by Padmanabhan et al. (US 20070166195) and Jasperse et al. (US 20250319466) as applied to claims 1 and 8 above, and further in view of Huemer (US 20100151512).
Re claims 2 and 9: Loderer as modified by Padmanabhan and Jasperse teaches the IVD analyzer and method, wherein the piezo actuator (Loderer, 27/31) and the piezo receiver (Loderer, 29/33) are surrounding the cuvette (Loderer, T) (Loderer, fig. 6), but does not specifically teach a ring shaped such as to form an optical window in the middle of the ring for the optical measurement of the biological sample through the cuvette. Huemer teaches an IVD analyzer (fig. 3 and 4), wherein a piezo transducer (2) is ring shaped such as to form an optical window (25a) in the middle of the ring for the optical measurement of a biological sample (28) through a cuvette (20) (see fig. 3, 4 and 6). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a ring shape for the piezo receiver and actuator of Loderer as modified by Padmanabhan and Jasperse similar to Huemer in order to lyse and detect air in the sample without blocking the optical measurement from occurring at the sample providing for a compact design with multiple modes of operation (MPEP, 2144.04, VI, C).
Allowable Subject Matter
Claims 4-7, 11-13 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regards to claims 4 and 11, the prior art of record individually or in combination with fails to teach the IVD analyzer according to claims 3 and 1 and the method in claims 10 and 8 respectively as claimed, more specifically in combination with wherein the amplitude is greater than about 200 V according to the lysis operating mode and smaller than about 50 V according to the air-detection operating mode.
In regards to claims 5 and 12, the prior art of record individually or in combination with fails to teach the IVD analyzer according to claims 3 and 1 and the method in claims 10 and 8 respectively as claimed, more specifically in combination with wherein the frequency is smaller than about 60 KHz according to the lysis operating mode and greater than about 60 KHz according to the air-detection operating mode.
In regards to claims 6 and 13, the prior art of record individually or in combination with fails to teach the IVD analyzer according to claims 3 and 1 and the method in claim 8 respectively as claimed, more specifically in combination with wherein, according to the air-detection operating mode, the controller is configured to scan a predetermined resonance frequency range and to correlate changes in a received wave amplitude spectrum relative to reference wave amplitude spectra and/or a shift of a wave phase profile relative to reference wave phase profiles with the presence and quantity of air in the cuvette.
In regards to claims 7 and 15, the prior art of record individually or in combination with fails to teach the IVD analyzer according to claim 1 and the method in claim 8 respectively as claimed, more specifically in combination with wherein the controller is configured to operate according to the air-detection operating mode before and after operation according to the lysis operating mode in order to additionally determine, by comparison, a lysis result obtained during the lysis operating mode.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER D BENNETT whose telephone number is (571)270-3419. The examiner can normally be reached 9AM-6PM EST M-F.
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/JENNIFER D BENNETT/ Examiner, Art Unit 2878