DETAILED ACTION
Response to Arguments
Applicant's arguments filed 19 May 2026 have been fully considered but they are not persuasive.
Claim rejections under 35 USC 112(b):
The issues have been overcome however, by amendment new issues are raised as discussed herein below.
Claim rejections under 35 USC § 102(a)(1): Zhang
The remarks have been found unpersuasive. The amended subject matter is discussed herein below. Specifically, the claimed identifiers and instructions are not specifically disclosed. In Zhang, figure 5 shows samples analyzed by plotting peaks against well numbers. In order for the peaks to be associated with well numbers for a moving well plate (i.e. XY stage carrying the source plate for rapid translation between source wells enabling high throughput sample processing (last paragraph on page 17)), the controller must recognize identifiers of each sample and perform analysis at each sample location (i.e. adjust the position operational setting from first position associated with first sample to second position). Therefore, the claims, as amended, are not sufficient to overcome the rejection in view of Zhang.
Claim rejections under 35 USC 102(a)(1): Datwani
The remarks generally take the position that the amended subject matter is not suggested by Datwani. This has not been found persuasive as discussed below. Moreover, the remarks take the position that output cannot be interpreted as an operational setting. This has not been found persuasive. The output is not interpreted as an operational setting, rather the positioning of the well-plate. That is, as discussed in paragraph [0098] the ejector acoustically couples to each of a series of fluid reservoirs. In order to acoustically couple to the reservoirs the reservoirs or ejector must inherently be positioned via translation. The translation for positioning a reservoir for acoustic coupling is an operational setting in order for data analysis to occur. An identifier is inherent in order for the reservoir location to be known for positioning in rapid succession.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 19-21 and 23-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 lacks written description for reciting “perform a mass analysis operation specific to the first sample with the mass analysis instrument based upon one or more analysis instructions associated with a first identifier associated with the first sample, wherein the first identifier is interpretable by the controller;
adjust at least one operational setting the mass analysis instrument based upon one or more analysis instructions associated with a second identifier associated with the second sample, wherein the second identifier is interpretable by the controller”
Specifically, the instant specification is devoid of:
1) any instructions associated with the with the first identifier associated with the first sample
2) performing a mass analysis operation specific to the first sample based upon above instructions
3) any instructions associated with a second identifier associated with the second sample
4) adjusting at least one operational setting of the mass analysis instrument based upon the instructions in (3) above
MPEP 2161.01 (I) recites:
“ The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir. 2005). Computer-implemented inventions are often disclosed and claimed in terms of their functionality. For computer-implemented inventions, the determination of the sufficiency of disclosure will require an inquiry into the sufficiency of both the disclosed hardware and the disclosed software due to the interrelationship and interdependence of computer hardware and software. The critical inquiry is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 682. 114 USPQ2d 1349, 1356 (citing Ariad Pharm., Inc. V. Eli Lilly & Co, 598 F.3d 1336, 1351, 94 USPQ2d 1161, 1172 (Fed. Cir. 2010) ”
In the instant case, the instant application teaches in paragraph [0006] of the published application “the systems and methods further provide for: identifying at least one analysis instruction associated with the plurality of samples; and, performing at least one of the capturing, diluting, transporting, or mass analyzing based on the at least one analysis instruction. In some aspects, the identifying is performed by an indicia physically associated with the plurality of samples, and wherein the indicia is accessed by the system to locate the associated analysis instruction corresponding to the plurality of samples”.
Similarly, language exists in paragraphs [0012], [0014] and [0074].
However, these paragraphs are merely a repetition of the desired claim result of generating instructions to perform mass analysis or adjust an operational parameter, without any disclosure as to what those instructions are, how they are associated with first or second identifiers nor how the operational parameters are adjusted based on said instructions associated.
Paragraph [0073] of the instant specification teaches “ identifier interpretable by the controller 130, 135, 145, by example through use of a machine reading device 65 such as a bar code or QR code reader, and configured to enable the controller to generate signals configured for causing at least one component 70, 80, 90, 95, 105, 100 of the system 1000 to perform at least one sample capture, sample transfer, dilution, dissolution, or mass analysis operation specific to the sample associated with the identifier”
Additionally, paragraph [0056] of the published application suggests a barcode is scanned and passed to the controller so as to cause settings to change. However, there is no disclosed criteria as to under what basis the mass spectrometer settings are changed based on an identified barcode.
That is, at best the specification provides a means for identifying some indicia by a controller, however is devoid of any suggestion as to how the controller achieves the claimed result associating some instructions with a particular identifiers associated with a first sample and second sample and then either performing mass analysis or adjusting an operational parameter based on the instructions. The specification only indicates there is some identifier that is interpretable by the computer and indicates some instruction to either adjust some operational parameter or initiate some analysis operation. Except for the general disclosure of operational parameters and mass analysis, the specification is completely silent with respect to any algorithm, steps, flow chart, prose to suggest what and how the instructions are implemented for mass analysis and adjustment. There is not even a single example of the procedure conducted.
MPEP 2161.01(I) further recites:
“It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) ”
Here, the specification does not disclose how the claimed result is achieved, therefore fails to demonstrate the possession of the claimed invention. In other words, the specification is devoid of any algorithm, flow chart, prose, etc…that demonstrate of the identifiers are associated with particular instructions to either perform mass analysis on a first sample or adjust operational parameters of the mass analysis of the second sample. Indeed, the adjusting operational parameters of the second sample suggests the operational parameters associated with the first sample are not adequate for analysis of the second sample. This would necessitate at the very least some discussion of which those operational settings are changed and how they are changed so as to instruct the mass analysis instrument to change those parameters to perform the mass analysis operation on the second sample. However, instead the specification is silent with respect to any “second sample” and merely vaguely discusses association between identifiers and instructions. Therefore, while QR codes, barcodes, readers and associating instructions with identifiers may have been within the skill of a person of ordinary skill in the art, these are not instructions per se, but instead specific analysis instructions associated with specific samples and specific adjustment instructions associated with operational settings for a second sample. Indeed the claim is clear that the mass analysis operation is “specific to the first sample” suggesting that it would be different from the mass analysis operation of the second sample, however any means of determining a specific mass analysis operation to a first sample is absent from the instant disclosure. As there is no disclosure as to what operational parameters for the second sample are adjusted, how instructions are determined and how they are implemented, this amounts to a lack of written description as to how the inventor intends to achieve the claimed function and therefore fails to satisfy the written description requirement under 35 USC § 112(a).
Claims 20-21 and 23-27 fail to meet the written description requirement by virtue of their dependencies on rejected claim 19.
As the specification provides no guidance as to how the procedure is conducted, the identifiers are interpreted broadly as any identifier. For instance, in Zhang numbered wells (fig. 5) are used to associate data with location of sample (i.e. interpretable by a controller), where mass analysis is performed based mass analysis instructions associated with well number 1 and an operational setting of the mass analysis system is adjusted (i.e. position of the breadboard to well number 2) based upon instructions associated with the second identifier (position of well number 2) which is interpretable by the controller (in order to associate data with well number 2). A similar interpretation is taken with respect to Datwani which teaches automatic alignment and rapid successive droplet ejection ([0098] and [0114]), suggesting that an identifier is required to determine position of reservoirs for droplet ejection (see further discussion below).
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 23 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.
Claim 23 is vague and indefinite for reciting “the first identifier is associated with data representing a plurality of analysis instructions”. Specifically, claim 19 requires “one or more analysis instructions associated with a first identifier”, therefore it is not clear whether the claimed “a plurality of analysis instructions” is the same or different from one or more analysis instructions of claim 19. No unambiguous determination can be made.
Claim 19 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. (“Acoustic Ejection Mass spectrometry for High-throughput analysis”, 01/29/2020) (submitted with the office action of 06/23/2025)
Regarding claim 19, Zhang et al. teaches a system for analyzing collections of substance samples (fig. 1 on page 9 and figure S1 on page 22), the system comprising at least one of each of:
a sample handler (source plate gripper in figure S1 on page 22);
a sample capture device (OPI and acoustic transducer in figures 1 and S1);
a mass analysis instrument (best seen in figure 2 on page 9, mass spectrometer inlet); and
a controller (paragraph bridging pages 17-18 teaches software for the breadboard system, the mass spectrometer and the OPI. Since software is executed on a computer, there is inherently a controller), the controller operative, in accordance with instructions received from at least one of an operator input device and machine-interpretable instructions stored in memory accessible by the controller, to generate signals (software is inherently saved to memory to execute control of the gripper, OPI and mass spectrometer) configured to:
cause the sample handler to collectively retrieve from a sample source a plurality of samples of one or more substances, and deliver the plurality of collected samples to the sample capture device (page 18 under “sample analysis with ADE-OPI-MS” note “loading the sample plate into the gripper of the x-y stage, stage translation to position selected source well above the acoustic transducer”, figure 1 shows a plurality of samples of one or more substances in wells. That is, the means for loading is the sample source, translating is retrieving the loaded plate from the source and translation to a position selected source well above the acoustic transducer is the delivering to the sample capture device (i.e. OPI));
cause the sample capture device to independently capture a first sample and a second sample of the collectively retrieved samples delivered by the sample handler, and transfer the first sample and the second sample to the mass analysis instrument (see figure 1 and discussion above);
perform a mass analysis operation specific to the first sample with the mass analysis instrument based upon one or more analysis instructions associated with a first identifier associated with the first sample, wherein the first identifier is interpretable by the controller (First interpretation: figure 5 shows mass analysis data collected associated with each well. In order for the data to be associated with each well the location of the well on the plate must be identified (i.e. identifier associated with the first sample well 1) and mass analysis operation specific to the first sample is the mass analysis performed by ADE-OPI-MS on the first well location with the first sample. The well location is clearly interpretable by the computer so as to process and associate data with the well number. Alternatively, page 18, under “sample analysis with ADE-OPI-MS” note dynamic fluid analysis (DFA) to determine acoustic ejection parameters of the OPI, page 16, first paragraph teaches DFA algorithms to determine droplet ejection parameters. That is, an identifier (desired droplet ejection parameter) interpretable by a controller to adjust a parameter of the OPI/acoustic transducer (capture device) to determined droplet ejection parameters for mass analysis)
adjust operational at least one setting of the mass analysis instrument based upon one or more analysis instructions associated with a second identifier associated with the second sample, wherein the second identifier is interpretable by the controller (first interpretation, well numbers of figure 5 are the second identifier with second sample in well number 2, wherein the adjusted operational setting is the well plate position for acoustic droplet ejection from well number 2. The second identifier (i.e. well number 2) is interpretable by the computer as evidence by the correlation between the well number and the data associated therewith). Alternatively, as discussed above DFA repeated for the second sample); and
perform a mass analysis operation specific to the second sample with the mass analysis instrument at the adjusted at least one operational setting (as seen in figure 5 mass analysis performed for each well number)
cause mass analysis instrument to ionize and detect one or more particles of the transferred sample (inherent to the apparatus of figure 1).
Claims 19-21 and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Datwani et al. (US 2019/0157061)(submitted with IDS).
Regarding claim 19, Datwani teaches a system for analyzing collections of substance samples (fig. 1a-1b), the system comprising at least one of each of:
a sample handler ([0092], “ a positioning means is incorporated in order to move a substrate containing the reservoirs (which may be positioned on a movable stage, for instance) relative to the acoustic ejector)”);
a sample capture device (51);
a mass analysis instrument (as seen in figure 1B); and
a controller (180), the controller operative, in accordance with instructions received from at least one of an operator input device and machine-interpretable instructions stored in memory accessible by the controller, to generate signals (inherent in order to control the acoustic droplet injection device and generate mass spectra seen in figures 4-9) configured to:
cause the sample handler to collectively retrieve from a sample source a plurality of samples of one or more substances (paragraph [0144] expressly teaches a 384-well plate and source plate mounted to motorized stage. Moreover, paragraph [0144] teaches fluid samples were loaded into wells. Thus the motorized stage collectively retrieve samples from the sample source (i.e. source of fluid samples that are loaded into well). Paragraph [0114] teaches the controller is coupled to the acoustic droplet injector device and is configured to operate any aspect of the acoustic droplet injection device, including “automation means for positioning one or more reservoirs into alignment with the acoustic radiation generator. Since the wells are mounted to a stage for loading the sample and the controller positions the reservoirs (i.e. wells see paragraph [0038]), the controller collectively retrieves the samples loaded from sample source via controlling the motorized stage ([0144] and [0114]) delivers the collected samples to the sample capture device ([0114], i.e. positioning near acoustic radiation generator 11 causes droplets 49 to be ejected to sample capture device or flow probe 51 see paragraph [0100] and figures 1a-1b)),and
cause the sample capture device to independently capture a first sample and a second sample of the collectively retrieved samples delivered by the sample handler ([0114] and [0100], note figure 1A shows 49 ejected toward the flow sampling probe. Note paragraph [0114] envisioned more than one reservoir positioned into alignment), and
transfer the first sample and the second sample to a mass analysis instrument (inherent to figure 1b showing MS downstream of acoustic droplet ejection device 11);
perform a mass analysis operation specific to the first sample (fig. 1A with first reservoir aligned MS is conducted) based upon one or more analysis instruction associated with a first identifier associated with the first sample ([0114] teaches automatic positioning one or more reservoirs into alignment with the acoustic radiation generator, thus in order to perform acoustic droplet formation and injecting droplets into sampling probe at each reservoir automatically, the device inherently requires some means of identifying the location of reservoir so as to automatically align the reservoir (with sample) so as to perform the mass analysis operation on the sample within the reservoir (i.e. droplet formation). See also [0098] which teaches substrate positioning means acoustically couples the ejector to each of a series of fluid reservoirs in rapid succession, thereby allowing fast and controlled ejection of fluid sample droplets from different reservoirs. In order to acoustically couple each reservoir in rapid succession the controller of [0114] must inherently interpret where each reservoir is located, this is interpreted to be the identifiers of the series of reservoirs)
adjust at least one operational setting (again the position of the second reservoir) of the mass analysis instrument ([0114] note the position of the second reservoir (i.e. automated positioning of one or more reservoirs)) based upon one or more analysis instructions associated with a second identifier associated with the second sample, wherein the second identifier is interpretable by the controller (as with the first reservoir above, in order to automatically align a second reservoir there inherently must be some means of identifying the location and instructing the automated alignment means to position the second reservoir with respect to the acoustic radiation generator, which is necessarily interpreted by the controller to automate the positioning);
perform a mass analysis operation specific to the second sample with the mass analysis instrument at the adjusted at least one operational setting (inherent for mass analysis of the additional reservoir)
cause the mass analysis instrument to ionize and detect one or more particles of the transferred sample (inherent since the controller controls device 11 and 11 supplies sample to be ionized and analyzed by MS).
Regarding claim 20, Datwani teaches wherein the sample capture device is configured, in accordance with signals generated by the at least one controller, to add to at least one of the first sample and the second sample at least one of a dilutant and a solvent (via solvent inlet 57), prior to transferring the at least one captured sample to the mass analysis instrument (as indicated by arrows from 57, see paragraph [0119]).
Regarding claim 21, Datwani teaches wherein the first identifier is configured to enable the controller to generate signals configured for causing at least one component of the system for analyzing collections of pluralities of substance samples to perform at least one sample capture, sample transfer, dilution, dissolution, or mass analysis operation specific to the sample associated with the identifier (via acoustic coupling ([0098]) the process in figure 1B is accomplished).
Regarding claim 23, Datwani et al. teach wherein the first identifier is associated with data representing a plurality of analysis instructions ([0098] via positioning to acoustically couple the process of sampling, ionization and mass spectrometry commences controlled by the controller), and wherein the controller is operative to perform at least one of the sample transfer, dilution, dissolution, or mass analysis operation based on at least one of the plurality of analysis instructions while the sample capture probe is capturing the second sample (controller 180 to perform the sample collection and analysis of figure 1B, note the claim is written as an apparatus, since the device is capable of capturing a second sample during a mass analysis operation of the first (i.e. for instance data processing), there is no structural distinction between the claimed invention and that of Datwani).
Regarding claim 24, Datwani et al. teach wherein the sample capture probe comprises a sample ejector (fig. 1a, 11).
Regarding claim 25, Datwani et al. teach wherein the sample capture probe comprises a sample ejector configured to independently eject a selected sample from the plurality of samples for capture by the sample capture probe ([0098]).
Regarding claim 26, Datwani et al. teach a sample staging device for positioning the selected sample for ejection by the sample ejector ([0098], substrate positioning means).
Regarding claim 27, Datwani et al. teach wherein the sample staging device is further operative to position a next selected sample for ejection by the sample ejector ([0098]) and optionally wherein the controller is further operative to coordinate the ejector to eject a plurality of selected samples before positioning a next sample relative to the sample ejector (optional is not required by the claim and thus not considered).
Note to applicant:
During the updated NPL search, it was found the applicants Chang Liu and Thomas Covey presented or were listed on a number of posters during the 67th ASMS and 66Th ASMS conferences on mass spectrometry. The subject matter appears particularly relevant to the claimed invention and not part of the file wrapper.
The examiner was unable to obtain them to for the purposes of examination. In order to provide a more complete record, it is noted that these posters exist and may be available as prior art. Making these posters or any presented content part of the record would make the record more complete. The list of titles are provided below:
“Acoustic-OPP-MS: The Next Generation BioAnalytical Platform for Drug Discovery with Ultra-High Throughput”
Acoustic-Open Port-Mass Spectrometry (AOMS) Enabled HTS: Assay Development for Choline Transporter (CHT) Uptake Function Assessment
A High-Throughput Mass Spectrometry Plate-Reader: Acoustic Droplet Ejection to an Open-Port Probe Sampling Interface
Acoustic-Open Port-Mass Spectrometry (AOMS): A New Platform for Ultrafast, Direct Human PK Analysis without Sample Preparation
Development and Optimization of a High-Throughput Open-Port Sampling Interface for Drug Discovery LC MS/MS Analysis;
A New Platform for High-Throughput Mass Spectrometry: Acoustic Droplet Ejection with an Open Port Probe Sampling Interface
Development and Optimization of a High-Throughput Open-Port Sampling Interface for Drug Discovery LC MS/MS Analysis
Acoustic-Droplet-Ejection to the Open-Port Probe Sampling Interface of MS (ADE-OPP-MS) - the Automated High-Throughput Bioanalysis Platform for Drug Discovery
Next Generation Sample Introduction for High Throughput Mass Spectrometry: Acoustic Droplet Ejection with an Open Port Probe
Drug Discovery Applications of ADE-OPP-MS (Acoustic-Droplet-Ejection coupled Open-Port-Probe Mass Spectrometry) Platform;
High-Throughput Analysis of Synthetic Samples from High-Density Microplates with ESI-MS Enabled by the Acoustic-Droplet-Ejection to the Open-Port Probe sampling interface
High-Throughput Analysis of Synthetic Samples from High-Density Microplates with ESI-MS Enabled by the Acoustic-Droplet-Ejection to the Open-Port Probe sampling interface
Relevant art of interest to the applicant:
US pgPub 2004/0026615 teaches an acoustic mist ionization mass spectrometry device.
Mason (US pgPub 2022/0170895) teaches a similar acoustic mist ionization mass spectrometry device as discussed above with respect to Sinclair.
Sinclair references a 2016 publication that teaches similar subject matter, see reference 19.
Sinclair al. (Sinclair et al. “Acoustic mist ionization platform for direct and contactless ultrahigh-throughput mass spectrometry analysis of liquid samples”, Analytical chemistry, 2019) (copy of publication submitted with the non-final rejection of 23 June 2025) in view of Dawati.
Regarding claim 19, Sinclair teaches a system for analyzing collections of substance samples (fig. 1), the system comprising at least one of each of:
a sample handler (plate handling robot, page 3791, right column first full paragraph)
a sample capture device (fig. 1a, elements 1, 4-5);
a mass analysis instrument (fig. 1a, heated transfer tube 6 and “MS”); and
a controller (page 3793, left column, last full paragraph “a new mass spectrometer interface with robust custom built hardware and software to acquire and process data”), the controller operative, in accordance with instructions received from at least one of an operator input device and machine-interpretable instructions stored in memory accessible by the controller, to generate signals (inherent to cause operation) configured to:
cause the sample handler to collectively retrieve from a sample source a plurality of samples of one or more substances and deliver the plurality of collected samples to the sample capture device (page 3791 right column, first paragraph ), and
deliver the plurality of collected samples to the sample capture device (fig. 1a);
cause the sample capture device to independently capture at least one of the collectively retrieved samples delivered by the sample handler (screen shot provided below from movie shows independent capture of one of the collectively retrieved samples),
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and
transfer the at least one captured sample to a mass analysis instrument (fig. 1a arrow to MS);
adjust at least one operational parameter of at least one of the mass analysis instrument (Sinclair teaches a real time recording of plate barcode and well location for every MS scan and saves a single mass spectrum per sample as a text file (page 3791, last paragraph). Thus each mass spectrum is associated with a particular well. Therefore, a parameter of the mass analysis instrument (i.e. mass spectrum of sample) is adjusted by designation of its sample location on which plate) and
cause the mass analysis instrument to ionize and detect one or more particles of the transferred sample (heated transfer tube results in improved ionization efficiency (page 3791, left column, last paragraph) thus provides ionization prior to mass analysis for detection).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J LOGIE whose telephone number is (571)270-1616. The examiner can normally be reached M-F: 7:00AM-3:00PM.
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/MICHAEL J LOGIE/Primary Examiner, Art Unit 2881
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