Prosecution Insights
Last updated: April 19, 2026
Application No. 18/021,583

PRETREATMENT MECHANISM-INTEGRATED NUCLEIC ACID ANALYSIS DEVICE

Final Rejection §102§103§112
Filed
Feb 16, 2023
Examiner
GORDON, BRIAN R
Art Unit
1798
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Hitachi High-Tech Corporation
OA Round
2 (Final)
65%
Grant Probability
Moderate
3-4
OA Rounds
3y 2m
To Grant
83%
With Interview

Examiner Intelligence

Grants 65% of resolved cases
65%
Career Allow Rate
609 granted / 942 resolved
At TC average
Strong +19% interview lift
Without
With
+18.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
51 currently pending
Career history
993
Total Applications
across all art units

Statute-Specific Performance

§101
1.1%
-38.9% vs TC avg
§103
26.2%
-13.8% vs TC avg
§102
26.6%
-13.4% vs TC avg
§112
37.3%
-2.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 942 resolved cases

Office Action

§102 §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 . Response to Arguments Applicant’s arguments, see remarks/arguments, filed December 12, 2025, with respect to the rejection(s) of the claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Weber, US 2014/0311090. Specification The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Claim Interpretation Content of Specification (k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p). The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”. A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus. It is noted that the claim directed to an apparatus (device). However, the claims mention a specimen (not defined as any specific substance, material, state of matter, etc.); fluid (unspecified fluid and/or gas); a member (not specifically defined); a holding mechanism operation range; a region, access region; and a magnetic bead. However, none of the prior art positively claimed as structural elements of the device (do not structurally define the device). All of such are considered as materials/articles intended be, can be, worked upon (used with) the device. It is noted that the claims are replete with “configured to…” clauses that do not provide for any further structural elements, but are directed to intended use of the device, respective elements of the device with further unclaimed materials/articles. There is no requirement for the claimed device to be used in any method at all including with any further unclaimed materials/articles as may be intended by applicant. It is noted that the terms “section”, “part”, “machine”, “mechanism”, “actuator”; “range”; “region”, and “unit” employed throughout the claims are relatively broad and are not defined as being any specific structures. It is noted that the term “pretreatment” does not provide for any further structure of anything. There is no requirement for any pretreatment (not defined as anything specific being done to anything prior to any point in time nor prior to any specific event (process step)) nor any “treatment” to be performed at all. The “in order to” clause of claim 7 is directed to an intended use/purpose. There is no requirement of any temperature control reaction of anything to be performed. There is no requirement for any heating, cooling, reacting, collecting, introducing, holding, etc. of anything to ever be performed. As to claim 9, it is presumed that “a computing device” refers to control PC 104. 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. Claims 1, 3-5 and 7-9 are 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. As to claim 1, it is unclear if it is intended for “a holding operation range” to be structure because such is not defined in the claims by any structures nor definitive structural boundaries so as to determine what is structurally required considered as “a holding mechanism operation range”. If such is intended to be structure, it is unclear if the holding mechanism operation range is an element of the holding mechanism because the claim does not provide for such. According to the specification, it appears such range refers to the possible, intended range of movement of the holding mechanism that is also not structure nor structurally defined in the claim. However, the claim is directed to an apparatus not a process of use. There is no requirement for any moving of the holding mechanism to ever be performed. For the reasons above, it is unclear how the structures recited in the last paragraph of claim 1 can be/are required to be/can be “above” a holding mechanism operation range. Anywhere the holding mechanism is located/moved is within such movement range not above such range. Claims 3-5 and 7-9 are rejected via dependency upon a rejected claim. As to claim 4, it is unclear if the claimed device comprises “a region” and “access region of the dispensing machine” and what is structurally considered as defining such regions because the claim does not clearly recite such. It appears that each of such regions are not structural elements of the device, but are directed to possible ranges of movement (no movement of anything is required to be performed) and/or what can be or is intended to be done in such regions relative to the unclaimed, structurally undefined member. However, it is noted that each of such regions are not structurally defined (by any specific structures nor any structural boundaries, dimensions, etc.) so as to determine where each of such regions begins and ends to be structurally distinguished from any other structures/regions. Furthermore, it is unclear how a region of unknown dimensions and dimensional values is being compared as being larger than a movement range (not structure) that is also not defined by any structure, dimensions, nor determinable values. Therefore, it is unclear what value(s) (dimensional, units…length, width, height, area, volume, etc.) is/are being compared. There is no requirement for anything to ever “access” an outside of any “access region” (not structurally defined nor positively claimed as a structural element of the claimed invention/device) of the dispensing mechanism. It is unclear what is an “access region” of the dispensing mechanism. Therefore, it is unclear what is structurally considered as an outside of an access region of the dispensing mechanism. As to claim 5, it is unclear how renaming/referring to the θ-axis movement mechanism as a “rotation actuator” further structurally limits the θ-axis movement mechanism because the phrase does not provide for any further structure of the θ-axis movement mechanism. This appears to be redundant in view of claim 1 which previously states “a θ-axis movement mechanism for rotational movement of the holding mechanism” which means the θ-axis movement mechanism is capable of being actuated to rotate the holding mechanism. Furthermore, it is unclear if it is intended for the holding mechanism to comprise two grip arms because the claim does not recite such. Reciting that the a grip arm actuator [is] connected to drop two grip arms does not require such two grip arms to be elements of the holding mechanism. If applicant intends for the holding mechanism to comprise two grip arms, then the claim should clearly recite such. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1, 3-4, and 9 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Weber, US 2014/0311090. Weber discloses a sample preparation system 10 in which the rotatable gripper 1 according to the invention is employed for the preparation of samples. The sample preparation system 10 includes a tool base station 2 in which a variety of tools, such as for example the rotatable gripper 1 (holding mechanism) or a gripper for a powder-dispensing head, are parked temporarily. A sample rack 5 holds a plurality of containers 81 (members, flow cell). In the storage rack 7 for dosage-dispensing heads, different materials contained in individual dispensing heads (dispensing machine) can be kept ready for use. When samples are to be prepared, containers 81 can be placed on the load receiver 6 (analysis section). The motion module 4 (conveyance mechanism) allows the tool holder 3 to be moved in the x-, y- and z-directions. (paragraph 0033-34, 36; Figure 1). As shown in Figure 4, the device comprise a conveyance mechanism including x, y, and z- axis movement mechanisms (4) extending in respective horizontal and vertical directions and are connected to each other in a perpendicular orientation relative to each other. The rotatable gripper 1 (θ-axis movement mechanism) is supported by the z axis movement mechanism and can be rotated. The gripper comprises a clamp 20 including 2 grip arms that can be actuated to be opened and claims to grip a member. (paragraph 0036). As to claim 9, the device can be controlled and operated via a computer system. (paragraph 0026). 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. Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber, US 2014/0311090 as applied above, and further in view of Oguri; Kazuyuki et al., US 2016/0154017. Weber does not disclose a respective translation part and an elastic connecting body of a grip arm. The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc., 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness. Oguri discloses a device comprising a gripper including arm portions 51a, 51b connected to respective translation parts 40 and biasing portions 54 (elastic body). It would have been obvious to and within the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to recognize that gripping mechanism maybe alternatively be that taught as taught by Oguri for gripping and transporting structures. Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Weber, US 2014/0311090 as applied above, and further in view of Yoshida et al., US 2019/0302135 and Toyoshima et al., US 2012/0149132. Weber does not disclose a temperature control mechanism and a magnet part. Yoshida discloses a device for sample pretreatment and analysis comprising a heater and a setting part 801 for cooling and heating (paragraphs 0157, 0220); and a BF separator for separating magnetic 1160 (paragraphs 0153, 157); and parts for holding sample containers 21-23 (flow cells). The device comprises a laser light (light source) and a measuring device 30 (optical unit) and an optical unit (paragraphs 0072, 0189); and stages 920, 922, 946, 947 for holding and conveying containers. Yoshida does not specify that the BF separator comprises a magnet part. Toyoshima discloses an analyzer comprising BF separators 11, 12 and magnet 40, 42a-b, (paragraphs 0009, 20, 30, 44, 49-50, 52-53; Figures 5, 9) for collecting and separating magnetic particles. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention recognize that device of Weber may be modified to include the use magnets in the BF separator of Yoshida to collect magnetic beads within the flow cells as taught by Toyoshima and provide for analysis for flow cell contents. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Okamoto; Hideho et al. discloses devices comprising dispensers and conveyors. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday.. 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, Charles Capozzi can be reached at 571-270-3638. 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. /BRIAN R GORDON/Primary Examiner, Art Unit 1798
Read full office action

Prosecution Timeline

Feb 16, 2023
Application Filed
Sep 15, 2025
Non-Final Rejection — §102, §103, §112
Dec 12, 2025
Response Filed
Mar 13, 2026
Final Rejection — §102, §103, §112 (current)

Precedent Cases

Applications granted by this same examiner with similar technology

Patent 12601475
FLUIDIZED BED REACTOR SYSTEM AND A METHOD OF OPERATING A FLUIDIZED BED REACTOR SYSTEM
2y 5m to grant Granted Apr 14, 2026
Patent 12595457
Cultivation Container Rack and Analyzing Device
2y 5m to grant Granted Apr 07, 2026
Patent 12590980
Automatic Analysis Device
2y 5m to grant Granted Mar 31, 2026
Patent 12590981
Automatic Analyzer
2y 5m to grant Granted Mar 31, 2026
Patent 12590281
Methods, Devices, and Apparatus for Washing Samples on Array Plates
2y 5m to grant Granted Mar 31, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

AI Strategy Recommendation

Get an AI-powered prosecution strategy using examiner precedents, rejection analysis, and claim mapping.
Powered by AI — typically takes 5-10 seconds

Prosecution Projections

3-4
Expected OA Rounds
65%
Grant Probability
83%
With Interview (+18.6%)
3y 2m
Median Time to Grant
Moderate
PTA Risk
Based on 942 resolved cases by this examiner. Grant probability derived from career allow rate.

Sign in with your work email

Enter your email to receive a magic link. No password needed.

Personal email addresses (Gmail, Yahoo, etc.) are not accepted.

Free tier: 3 strategy analyses per month