Prosecution Insights
Last updated: April 19, 2026
Application No. 18/286,497

Automatic Analyzer

Non-Final OA §103§112
Filed
Oct 11, 2023
Examiner
LIMBAUGH, KATHRYN ELIZABETH
Art Unit
1797
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Hitachi High-Tech Corporation
OA Round
1 (Non-Final)
76%
Grant Probability
Favorable
1-2
OA Rounds
3y 0m
To Grant
99%
With Interview

Examiner Intelligence

Grants 76% — above average
76%
Career Allow Rate
134 granted / 177 resolved
+10.7% vs TC avg
Strong +33% interview lift
Without
With
+33.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 0m
Avg Prosecution
29 currently pending
Career history
206
Total Applications
across all art units

Statute-Specific Performance

§101
7.0%
-33.0% vs TC avg
§103
39.4%
-0.6% vs TC avg
§102
20.1%
-19.9% vs TC avg
§112
27.8%
-12.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 177 resolved cases

Office Action

§103 §112
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. 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. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. A copy of Japanese Application JP2021-083767 has been filed with a priority date of 18 May 2021. Claim Status Claims 1-14 pending. Claims 1, 4-7, and 10-14 are rejected. Claims 2-3 and 7-9 are objected. Claim Objections Claims 3-4 and 7-9 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. The cited references below fail to teach nor fairly suggest “wherein the predetermined condition is temporal information set to the reagent container specified” as recited in instant claim 2. In other words, none of the prior art discloses wherein temporal information related to a reagent container must be fulfilled during an analysis operation prior to performing a conditioning operation related to operation of a reagent dispensing mechanism. As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a). Claims 13 is objected to because of the following informalities: it appears there should be a “the” between “is” and “same” for proper grammar. Appropriate correction is required. 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: “ a storage storing” and “a control unit controlling” in claim 1. The disclosure of the instant invention defines the storage as a reagent disk and the control unit as a computer (see [0143] of the specification). Therefore, the disclosure of the invention provides sufficient structure for performing the functions of storing and controlling. 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. 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 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 appl icant regards as his invention. Claims 1, 4-7, and 12 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 1 recites “the control unit executes analysis while switching the reagent used according to an analysis item” in lines 10-11. The way the limitation is written is unclear. Firstly, it is unclear if any steps following “executes” is further limiting to the automatic analyzer. Secondly, “executing analysis while switching the reagent used” is unclear as how can you be performing analysis while simultaneously switching the reagent being used? Recommend amending to recite “the control unit is programmed to execute[[s]] analysis , while switching wherein the reagent used is switched according to an analysis item” for clarity (see MPEP 2111.05 Functional and Nonfunctional Descriptive Material and Fig. 17 of the instant disclosure). Claim 4 recites “it has exceeded the elapsed time” in line 2, however, it is unclear what “it” is exactly supposed to refer to. Claims 4 – 7 depend on claim 3 which defines two different “elapsed time, therefore, it is unclear in claims 4-7 which “elapsed time” is being referred to. Claim 12 recites “wherein the conditioning operation uses dispensing cycle by two or more cycles” in lines 1-3 which is unclear. Recommend amending the claim limitation to recite “the conditioning operation uses comprises multiple dispensing cycle s, by wherein the number of cycles is two or more cycles” for clarity. 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 . 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, 10, and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over JP2010-060441A to Shibuya et al. (herein Shibuya) (see machine translation provided by Applicant) as cited on the 5/20/2025 IDS in view of JP2000-131324 to Saito et al. (herein Saito). Regarding claim 1 , Shibuya discloses an automatic analyzer for qualitatively and quantitatively analyzing various components contained in a biological sample (see [0001]), wherein a reaction of the sample with a stored reagent is analyzed (see [0012]). Shibuya discloses the automatic analyzer comprises: a reagent dispensing mechanism 5 including a nozzle 21 that aspirates and discharges the reagent (see [0016 – 0020]; Figs. 1-5); a reagent disk 1 (i.e., storage) storing a reagent container 8 filled with the reagent (see [0016-0020]; Figs. 1-5); and a control system 200, wherein the control system 200 is a general purpose computer for storing analysis control information, inputting information, and controlling analysis (see [0017]). Shibuya discloses that control system 200 controls the dispensing mechanism 5 to execute a condition operation of lowering the nozzle to pass through an aspiration port 22 of the reagent container of a target 8 and lifting the nozzle 21 when a predetermined condition ( i.e., any condition specified by the control system 200) is fulfilled during an analysis operation (see [0017-0027]; Figs. 1-5). Shibuya fails to explicitly disclose “analysis while switching the reagent used according to an analyte item” as recited in the instant claim. Saito discloses an analytical apparatus that controls the opening and closing of a reagent container, wherein the apparatus comprises multiple reagents and wherein the reagent is chosen based on the requested analysis item (i.e., switched) (see [0001-0004]). Saito further discloses a control unit with mechanism control (see [0006]). Saito and Shibuya are analogous in the field of automatic analyzers for reagent control. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to program the control system of Shibuya to switch the reagent based on an analysis item for the benefit of being able to perform multiple types of analysis (see [0004] of Saito). Regarding claim 10 , the combination of references above render obvious the invention of claim 1. As Shibuya discloses the control system 200 stores analysis control information, accepting input information, and controlling analysis operation (see [0017]), Shibuya reads on “the predetermined condition is request information using the reagent of a target for analysis” as implicitly has to be done to perform analysis. Regarding claims 12-14 , the combination of references above render obvious the invention of claim 1 and Shibuya discloses the conditioning operation can be repeated multiple times (i.e. multiple cycles) (see [0022]). As Shibuya discloses the control system 200 stores analysis control information, accepting input information, and controlling analysis operation (see [0017]), Shibuya suggests that the conditioning operation can either have all the cycles be the same or is capable of adjusting the analysis control wherein at least one of the cycles is different. Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over JP2010-060441A to Shibuya et al. (herein Shibuya) (see machine translation provided by Applicant) as cited on the 5/20/2025 IDS in view of JP2000-131324 to Saito et al. (herein Saito) and United States Patent Application US 2020/0191816 to Onuki et al. (herein Onuki ). Regarding claim 11 , the combination of references above render obvious the invention of claim 1. Onuki discloses a reagent dispenser designed for crystallization prevention of a reagent (see abstract). Saito and Shibuya are analogous in the field of automatic analyzers for reagent control. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the reagent of a target of execution of the conditioning operation is a predetermined reagent in which analysis accuracy is affected by crystallization at the aspiration point for benefit of monitoring crystallization so that accurate dispensing and analysis can be performed (see [0015]). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KATHRYN E LIMBAUGH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0787 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 7:00-5:00 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Lyle Alexander can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571) 272-1254 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /KATHRYN ELIZABETH LIMBAUGH/ Primary Examiner, Art Unit 1797
Read full office action

Prosecution Timeline

Oct 11, 2023
Application Filed
Mar 19, 2026
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
76%
Grant Probability
99%
With Interview (+33.4%)
3y 0m
Median Time to Grant
Low
PTA Risk
Based on 177 resolved cases by this examiner. Grant probability derived from career allow rate.

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