Prosecution Insights
Last updated: April 19, 2026
Application No. 18/265,787

SEPARATION COLUMN CONNECTION DEVICE AND SEPARATION DEVICE

Non-Final OA §102§103§112
Filed
Jun 07, 2023
Examiner
MCDERMOTT, JEANNIE
Art Unit
1777
Tech Center
1700 — Chemical & Materials Engineering
Assignee
Hitachi High-Tech Corporation
OA Round
1 (Non-Final)
60%
Grant Probability
Moderate
1-2
OA Rounds
2y 10m
To Grant
75%
With Interview

Examiner Intelligence

Grants 60% of resolved cases
60%
Career Allow Rate
124 granted / 208 resolved
-5.4% vs TC avg
Strong +15% interview lift
Without
With
+15.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
25 currently pending
Career history
233
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
51.2%
+11.2% vs TC avg
§102
16.4%
-23.6% vs TC avg
§112
21.4%
-18.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 208 resolved cases

Office Action

§102 §103 §112
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 . 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 interpreted in view of the instant specification and include: driving device in claim 1 to include to include a at least gears, crank arms, a motor, or equivalents thereof, fixing member in claim 1, stop or equivalents thereof, interlocking mechanism in claim 1 interpreted to include a pin, plate, latch or equivalents thereof. 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 applicant regards as his invention. Claims 4, 5 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. Claim 4 recites the limitation wherein a diameter of the first hole and a diameter of the second hole have sizes that block contact of an operator from an inside of the column case via the first hole and the second hole to the first pipe and the second pipe in the open state, this is unclear, is this blocking an operator with access to the inside of the column case from contacting the pipes, or blocking the operator from access to the inside of the column case through the areas around the first and second pipe. Claim 5 is rejected as dependent on a rejected claim. Claim Rejections - 35 USC § 102 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 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. Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lerner (US 12,422,777) With respect to claim 1, Lerner teaches a clamp for chromatography columns (abstract, a separation column connection device), comprising seals 12 and 16 with openings 14 and 18, movable seal 16 arranged in tube 44, and the openings coupled to pipes 38 and 40 (C2/L34-C3/L52, C4/L53-C5/L4, a first pipe that moves) tube 44 which can fit around a chromatography column (C4/L53-C5/L5, supporting a column case arranged between the first pipe and the second pipe, the column case having a first hole with which the first pipe communicates and a second hole with which the second pipe communicates, supporting a first pipe along a first direction and moves the first pipe in the first direction), lever 36 actuates the movable seal between rest and work positions (C4/L25-55, a driving device), first seal 12 a non-movable seal, and controlled force can be exerted on the seal by a resilient force (C3/L31-52, C5/L5-35, a fixing member that fixes a second pipe so as to be opposed to the first pipe along the first direction), clamp 10 (Fig. 1, an interlocking mechanism that moves the column case in the first direction in conjunction with movement of the first pipe), the movable seal actuates between rest and work positions (C4/L25-55, Figures, the column case allows a column cartridge retaining a separation column to be connected and disconnected, and wherein the driving device moves the first pipe and the interlocking mechanism such that two states are reversibly taken, the two states including a closed state in which the separation column is pressurized and sandwiched between the first pipe and the second pipe and an open state in which the first pipe and the second pipe are positioned at an outer side of the column case). With respect to claim 2, the separation column connection device according claim 1, is taught above. Lerner teaches the clamp (interlocking mechanism) presses the column between the seals, and the column is compressed against the seals, at minimum the compression of the seal would move the column farther than the tube (C8/L26-67, C/-C10, Figs., wherein the interlocking mechanism moves the column case such that a moving amount of the column case is less than a moving amount of the first pipe). With respect to claim 3, the device of claim 1, is taught above. Lerner teaches seals 16 and 12 (connecting to first and second pipes as discussed above, and tube 44 see Figs. 2-6 (the open state is a state where an interval between the first pipe and the second pipe is larger than a width in the first direction of the column case). With respect to claim 4, the device of claim 1, is taught above. See 112(b) rejection above, Lerner teaches a tube which may fit around the column case as discussed above, absent clarification which would prevent an operator from accessing the first or second pipe from inside the tube, a diameter of the first hole and a diameter of the second hole have sizes that block contact of an operator from an inside of the column case via the first hole and the second hole to the first pipe and the second pipe in the open state. 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 Lerner in view of Muller (US 5,194,225). With respect to claim 5, the device of claim 4 is taught above. Lerner teaches tube 44 which can fit around the column, but is silent as to the diameter of the first hole and the diameter of the second hole are 10 mm or less. Muller teaches chromatography cartridge systems and that customary columns have a diameter of 3-80 mm are usually employed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lerner’s taught device such the diameter of the first hole and the diameter of the second hole are 10 mm or less depending on the size of the column cartridge as according to Muller customary columns are 3-80 mm (see MPEP 2144.05 in the case of overlapping ranges a case of prima facie obviousness exists) and as when a primary reference is silent as to a certain detail, one of ordinary skill would be motivated to consult a secondary reference which satisfies the deficiencies of the primary reference. Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lerner in view of Nogami (US 2022/0155266), Ozbal (US 11,531,009), and Brann (US PG Pub 2013/0306653). With respect to claim 12, the device of claim 1 is taught above. Lerner is silent as to the column cartridge includes an information recording unit allows recording of information of the column cartridge, wherein the separation column connection device further includes an information reader disposed at a position opposed to the information recording unit, the information reader allowing recording and writing of information of the information recording unit, and wherein the information reader has a readable range larger than a moving range of the information recording unit between the open state and the closed state, however the use and placement of a barcode and reader would have been obvious to one of ordinary skill in the art in view of Nogami, Ozbal, and Brann, Nogami teaches a similar column change apparatus (abstract, Fig. 2), with an RFID tag and reader are employed (abstract, 0055, 0073), Ozbal teaches an automated column changer with a motorized stage and movable coupler (Fig. 9, C 13L17-50), where codes are reach by the system in various locations (C29-C30), Brann teaches a connector apparatus for a column (Figs. 4-6) and cartridge and system with barcodes and a reader (0044). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Learner’s taught device to include the column cartridge includes an information recording unit allows recording of information of the column cartridge, wherein the separation column connection device further includes an information reader disposed at a position opposed to the information recording unit, the information reader allowing recording and writing of information of the information recording unit, and wherein the information reader has a readable range larger than a moving range of the information recording unit between the open state and the closed state, as barcodes and readers are known in the art as shown by Nogami, Ozbal and Brann, and to optimize the placement to ensure proper reading of the barcodes. Allowable Subject Matter Claim 6-11 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. While the use of a motor and heating means as required in claims 6 and 8 are known in the art, the full scope of the limitations of claims 6 and 8 are not taught or suggested by the prior art. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Van Pelt (US10,077859)’ Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANNIE MCDERMOTT whose telephone number is (571)272-4479. The examiner can normally be reached Monday - Friday 8:30 - 5:00 EST. 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, Vickie Kim can be reached at 571-272-0579. 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. /JEANNIE MCDERMOTT/ Examiner, Art Unit 1777 /BRADLEY R SPIES/Primary Examiner, Art Unit 1777
Read full office action

Prosecution Timeline

Jun 07, 2023
Application Filed
Jan 10, 2026
Non-Final Rejection — §102, §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
60%
Grant Probability
75%
With Interview (+15.4%)
2y 10m
Median Time to Grant
Low
PTA Risk
Based on 208 resolved cases by this examiner. Grant probability derived from career allow rate.

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