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 . This is a first action on the merits of the application. Claims 1-15 are pending.
Election/Restrictions
Applicant's election with traverse of invention I, claims 1-13 in the reply filed on November 28, 2025 is acknowledged. Claims 14-15 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “Apparatus for detecting and displaying an operational condition of a” in line 1. It is respectfully suggested to amend the limitation to “An apparatus
Appropriate corrections are required.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Beals et al. (US 2018/0364205 A1, herein referred as “Beals”).
In regard to claims 1 and 13, Beals discloses techniques for determining equilibration and stability in a system, such as a system including one or more scientific instruments comprising liquid chromatography (LC) (paragraph [0002]; [0016]).
Beals discloses an apparatus for detecting and displaying an operational condition of a liquid chromatography (LC) system without user intervention (paragraphs [0005]; [0006], LC in conjunction with Mass Spectrometer (MS) in for automatic monitoring and controlling of the system in Fig. 1) comprising:
(i) an LC column of an LC system that receives a mobile phase solution and performs a separation of one or more compounds from a sample of the mobile phase solution over time (110, Fig. 1; paragraph [0003]);
(ii) a pressure sensor of the LC system that measures a pressure of the mobile phase solution in the LC column over time, producing a plurality of pressure measurements over time (paragraph [0060], measure LC column pressures; Fig. 5 and Fig. 6A show pressure measurements over time);
(iii) a display device (computer 116, Fig. 1 and data system 320, Fig. 3 directs a monitor to show data and analysis); and
(iv) a processor that (a) receives the plurality of pressure measurements over time from the pressure sensor, (b) calculates values for one or more of parameters from the plurality of pressure measurements over time, (c) classifies the values of the one or more of the six parameters as one of one or more operational conditions of the LC system using a machine learning model, and (d) displays on the display device an indicator of the classification of the values as one of the one or more operational conditions (paragraph [0099], “the computer 116, Fig. 1 may process the data received via the monitored data channels using various processing algorithms (e.g., artificial intelligence algorithms, machine learning algorithms, etc.) to determine proper functionality of the system 100, Fig. 1. For example, by using the processing algorithms, the computer 116 may generate new expected threshold values for various components of the system 100. Similarly, the computer 116 may modify existing expected threshold values. Such new and/or modified expected threshold values may then be used to define a state of equilibrium, healthy operating conditions, and/or starting conditions for the system 100, which may be used in subsequent experiments and/or analyses. In some embodiments, the new and/or modified expected threshold values, defined states of equilibrium, healthy operating conditions, and/or starting conditions for the system may be outputted to a user for approval” which meets the recited processer function recited in claim 1).
But Beals discloses does not explicitly disclose the specific feature of the process that conduct or operate as: (I) calculates values for one or more of six parameters from the plurality of pressure measurements over time, wherein the six parameters include a beginning pressure (PB), an ending pressure (PE), an average pressure (T1) for a first half of the separation, an average pressure (T2) for a second half of the separation, a ratio T1/PB, and a ratio T2/PB, (II) classifies the values of the one or more of the six parameters as one of one or more operational conditions of the LC system using a machine learning model, wherein the model is created from values of the one or more of the six parameters calculated from each separation of a plurality of known separations for each of the one or more operational conditions, and (III) displays on the display device an indicator of the classification of the values as one of the one or more operational conditions as recited in claim 1.
However, it is noted that claim 1 is about an apparatus, not about a process.
It has long been held that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990); see also Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (“An intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.”); In re Michlin, 256 F.2d 317, 320 (CCPA 1958) (“It is well settled that patentability of apparatus claims must depend upon structural limitations and not upon statements of function.”). It is the examiner’s assessment that the processor taught by Beals fully possesses the structural limitations for conducting the claimed features (I) and (II), set forth above.
Moreover, before the effective filing date of the claimed invention, the claimed features (I) and (II), set forth above, would have been obvious to one of ordinary skill in the art through routine experimentation in an effort to optimize the operation and monitoring of LC in conjunction with Mass Spectrometer (MS) in for automatic monitoring and controlling of the system in Fig. 1 and utility taking into consideration the operational parameters of the LC-MS operation (residence time, temperature, pressure, throughput), the geometry of the LC column bodies, the physical and chemical make-up of the LC feedstock as well as the nature of the LC separation end-products.
Beals discloses an embodiment of calculating values for one or more of parameters from the plurality of pressure measurements over time in Fig. 5 or Fig. 6A. In light of teachings from Beals and the examiner’s assessment set forth above, the recitation “the processor calculates values for all six of the one or more of six parameters from the plurality of pressure measurements over time” recited in claim 13 is considered prima facie obvious.
In regard to claim 2, Beals discloses new and/or modified expected threshold values may then be used to define a state of equilibrium, healthy operating conditions, and/or starting conditions for the system (paragraph [0099]) which directs one or more operational conditions comprise normal operation with no LC equipment setup issues.
In regard to claims 3-7, claim limitations directs one or more operational conditions that is a part of operating processor.
As set forth above, claim 1 is about an apparatus, not about a process. Moreover, it has long been held that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990); see also Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (“An intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.”); In re Michlin, 256 F.2d 317, 320 (CCPA 1958) (“It is well settled that patentability of apparatus claims must depend upon structural limitations and not upon statements of function.”).
Beals discloses new and/or modified expected threshold values may then be used to define a state of equilibrium, healthy operating conditions, and/or starting conditions for the system (paragraph [0099]) which directs one or more operational conditions comprise normal operation with no LC equipment setup issues.
But, Beals does not explicitly disclose specific embodiments of one or more operational conditions recited in claims 3-7.
However, it is reasonably interpreted that the embodiments of one or more operational conditions recited in claims 3-7 are considered as obvious conditions for operating and controlling LC in conjunction with MS that any person skilled in the art is enabled to make and use by modifying the teachings of Beals, set forth above, through routine experimentation in an effort to optimize the operation and monitoring of LC in conjunction with Mass Spectrometer (MS) in for automatic monitoring and controlling of the system in Fig. 1 and utility taking into consideration the operational parameters of the LC-MS operation (residence time, temperature, pressure, throughput), the geometry of the LC column bodies, the physical and chemical make-up of the LC feedstock as well as the nature of the LC separation end-products.
In regard to claims 8 and 9, Beals does not explicitly disclose the location of pressure sensor with respect to LC column. However, the employment of an output pressure transducer between mobile phase pump and LC column is well established in the field as evidenced by Wolze (US 5,457,626, col. 7, line 67 thru col. 8, line 3, As shown in FIG. 2A, pump system 100 also uses a pressure transducer 40 to monitor pressure at the pump output port 12, which pressure data is used by digital control system 128 to rapidly derive flowrate on a short term basis). Consequently, a skilled person would choose the position of the pressure sensor according to the circumstances as recited in claims 8 and 9, thereby this renders the recitations prima facie obvious.
In regard to claims 10, 11 and 12, Beals discloses the machine learning model is created using a machine learning algorithm (paragraph [0099]). It is known in the art that machine learning algorithm encompasses a support vector machine (SVM) algorithm and a decision tree algorithm as evidenced by Burbidge et al. (Drug design by machine learning: support vector machines for pharmaceutical data analysis, Computers and Chemistry 26 (2001) 5–14).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YOUNGSUL JEONG whose telephone number is (571)270-1494. The examiner can normally be reached on Monday-Friday 9AM-5PM.
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/YOUNGSUL JEONG/Primary Examiner, Art Unit 1772
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