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 .
Applicant Response
Applicant's response, filed 06/15/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 7-8 are newly added.
Claims 1-8 are pending and under examination herein.
Claims 1-8 are rejected.
Priority
The instant application is a National Stage entry of PCT/JP2021/016671 , International Filing Date: 04/26/2021, which claims the benefit of foreign priority to JP 2020-146823, filed 09/01/2020. As such, the effective filing date assigned to each of claims 1-8 is 09/01/2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed 10/23/2025 is in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. A signed copy of the IDS is included with this Office Action.
Drawings
The drawings filed 02/07/2023 were accepted by the examiner in the office action mailed 04/21/2026.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
In claim 1:
protocol selection input reception unit configured to receive an input for selecting one of the plurality of protocols;
a sample position display unit configured to read, from the storage unit, information on a position of the sample disposing portion and information on the sample corresponding to the protocol input to the protocol selection input reception unit and display the information on the position and the information on the sample on the display unit;
a display item selection unit configured to receive selection of one or both of the information on the position of the sample disposing portion and the information on the sample;
a display switching unit configured to switch display of the display unit by the sample position display unit depending on selection through the display item selection unit.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
With respect to the protocol selection input reception unit, sample position display unit, and display switching unit, the instant specification discloses these units are included as functional blocks in the controlling/processing unit, which is a general personal computer, and each functional block described above is embodied by a processor executing an analysis program installed beforehand (para 0026).
Applicant’s Arguments filed 06/15/2026 state on p 6, para 7 that paragraphs [0036]-[0066] of the specification and Fig. 2 as originally filed, disclose the selection of display items is provided using the selection display item selection checkboxes 653, and as such, the "display item selection unit" is incorporated as a part of the control/processing unit 4, like the other recited "units."
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The rejection of claims 1-5 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 are withdrawn in view of Applicant’s Arguments filed 06/15/2026, which state on page 6, para 7 that paragraphs [0036]-[0066] of the specification and Fig. 2 as originally filed, disclose the selection of display items is provided using the selection display item selection checkboxes 653, and as such, the "display item selection unit" is incorporated as a part of the control/processing unit 4, like the other recited "units" (i.e. computer implemented). This is found to be persuasive.
The rejection of claims 1-5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn in view of Applicant’s Arguments filed 06/15/2026, which state on page 6, para 7 that paragraphs [0036]-[0066] of the specification and Fig. 2 as originally filed, disclose the selection of display items is provided using the selection display item selection checkboxes 653, and as such, the "display item selection unit" is incorporated as a part of the control/processing unit 4, like the other recited "units" (i.e. computer implemented). This is found to be persuasive.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1-8 appear to be free from a rejection under 35 U.S.C. 101, as the claims recite statutory subject matter (Step 1: YES) and the claims do not recite any concepts that equate to an abstract idea, law of nature or natural phenomenon (Step 2A, Prong 1:NO).
Claim Rejections - 35 USC § 102
The rejection of claims 1-6 under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (Analytical chemistry 2011, 83(16); hereafter referred to as Liu) are withdrawn in view of claim amendments filed 06/15/2026, as Liu does not appear to disclose displaying information of the position comprising representations of the actual positions of the sample disposing portions in the sample housing member.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Analytical chemistry 2011, 83(16); previously cited; hereafter referred to as Liu), in view of Beckman Coulter(Biomek® Software Version 4.1 User’s Manual 2018; newly cited; hereafter referred to as the Biomek Software User’s Manual Version 4.1), and Beckman Coulter (Reliability in the things you can’t see: Biomek software solution 2017. Beckman Coulter Life Sciences; newly cited; hereafter referred to as the Biomek Software Solution Brochure). This rejection is newly recited and necessitated by claim amendments.
With respect to claims 1 and 6-8, Liu discloses an automated, information-dependent, iterative MS/MS acquisition (IMMA) tool for improving MS/MS efficiency, increasing proteome coverage, and shortening analysis time for high-throughput proteomics applications based on the LC–MALDI MS/MS platform (title; abstract)
Liu further discloses IMMA software supports an automated and integrated pipeline for data acquisition, processing, analysis, and storage, indicating that it is computer implemented (p 6287, col 2, para 6; fig 1).
Liu discloses with IMMA, one can customize the settings for each MS/MS run by using a library of pre-saved methods and parameters, and then save them as protocols that can be recalled and applied to newly selected targets (supplemental p 15, para 1). Liu further discloses a screen shot of the user interface (GUI) of IMMA software in figure S3, indicating there is a display unit to display the GUI. Figure S3 shows:
On the right panel is the job-tree that is connected to the Oracle Database embedded in the 4800/5800 MALDI TOF/TOF and it displays all LCMS plates available for MS/MS analysis or database search. Liu further discloses that all available MS/MS acquisition and processing methods were initially created in 4000 Series Explorer Software and saved individually in the Oracle 14 database (supplemental p 14, para 2).
On the left panel, all acquisition/processing parameters used by IMMA are displayed and subjected to change by users.
On the middle panel, selected LCMS plate(s) can be defined and queued for MS/MS acquisition, with data management, job queue parameters and job queue sections. Briefly, the “acquisition method” defines the MS/MS method and parameters, and “processing method” defines the database-searching parameters. The “AutoPopulate” button creates an MS/MS queue for a batch of LCMS plates, while the “Add one iteration” button creates one iteration at a time. A completely defined IMMA procedure can be saved as a “protocol” by using the “save” button, and recalled and applied to the currently selected plate(s) by using the “load protocol” button and the browsing capability. All items in the queue are displayed in a window and available for modification prior to execution. Pressing the “process” button will start the execution of all items in the queue. In addition, it will also execute batch processing of database search for selected MS/MS runs (the top portion of the panel).
However, Liu does not appear to disclose displaying the information on the position comprising representations of the actual positions of the sample disposing portions in the sample housing member, and displaying the information at locations of the representations of the actual positions of the sample disposing portions in the sample housing member.
However, with respect to claims 1 and 6-8, the prior art to the Biomek Software User’s Manual Version 4.1 discloses software with information about the liquid-handling system, including information specific to an instrument, including additional components installed, deck layout, and framing information and information about labware, tip, and liquid types, and pipetting techniques and templates (p xlvii, para 1-p xlviii, para 7). The Biomek Software User’s Manual Version 4.1 further discloses the GUI includes a deck editor which allows Biomek Software to select, edit and remember each deck position for each Biomek pod, and the Deck Editor is used to set the properties of each active labware positioner (ALP), microplates and position, including the names (chapter 5; chapter 15).
The prior art to the Biomek Software Solution Brochure, also in the same field of endeavor, discloses numerous software solutions that simplify the complexity of sample and data handling through intelligent processing to meet individual workflow needs, and summarizes various software add-ons, including flexible software package designed to provide complete automation and process control supporting a wide variety of applications across life sciences, such as through integration of devices and use of data at the plate and well level to make decisions (p 2, para 1-p 4, last para).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the GUI of Liu with the deck editor function disclosed by the Biomek Software User’s Manual Version 4.1, because it would simplify the complexity of sample and data handling through intelligent processing to meet individual workflow needs, and provide complete automation and process control supporting a wide variety of applications across life sciences, such as through integration of devices and use of data at the plate and well level to make decisions, as disclosed by . There would be a reasonable expectation of success because including representations of the actual positions of the sample disposing portions as disclosed by the Biomek Software User’s Manual Version 4.1 and the Biomek Software Solution Brochure would not impede the steps of Liu as Liu already considers the position of the wells.
With respect to claims 2-4, Liu discloses using 5800 or 4800 MALDI TOF/TOF mass spectrometer with LCMS plates, indicating sample disposing portions would be provided in a lattice pattern. Liu further discloses the user can define a specific IMMA procedure, including setting acquisition and processing parameters, for the spot set(s) selected, suggesting that the user can select which arrangements to show as processed, and the GUI would display the spot set(s) that were used based on the parameters selected by the user (supplementary p 14, para 2-p15, para 1; Fig S3).
With respect to claim 5, Liu discloses the GUI displays text information for specifying the different samples via iTRAQ labels (p 6287, col 1, para 4; fig S3).
Therefore, the invention is prima facie obvious.
Response to Applicant’s Arguments
Applicant’s arguments have been fully considered, and new art has been applied to teach the amended limitations of the instant claims.
Double Patenting
Ther rejections of claims 1-6 on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US11988680B2 in view of Liu et al. (Analytical chemistry 2011, 83(16); hereafter referred to as Liu) are withdrawn in view of claim amendments filed 06/15/2026, as neither the reference Patent nor the prior art to Liu appear to disclose displaying information of the position comprising representations of the actual positions of the sample disposing portions in the sample housing member.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. US11988680B2 in view of Liu et al. (Analytical chemistry 2011, 83(16); hereafter referred to as Liu), Beckman Coulter(Biomek® Software Version 4.1 User’s Manual 2018; newly cited; hereafter referred to as the Biomek Software User’s Manual Version 4.1), and Beckman Coulter (Reliability in the things you can’t see: Biomek software solution 2017. Beckman Coulter Life Sciences; newly cited; hereafter referred to as the Biomek Software Solution Brochure). This rejection is newly recited and necessitated by claim amendments.
Response to Applicant’s Arguments
Applicant’s arguments have been fully considered, and new art has been applied to teach the amended limitations of the instant claims.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
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/N.D./ Examiner, Art Unit 1686
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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