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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on November 12th, 2025. Claims 16-18, 22, and 24-28 are pending. Claims 1-15, 19-21, and 23 are canceled.
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:
Reagent storage unit to store a reagent bottle…as in cls. 16/17
Reagent transport unit to transport…as in cls. 16/17
Reagent loading unit for mounting a reagent bottle…as in cls. 17/18
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.
A reagent disc and equivalents thereof (see pars.[0038,0203] of Applicant’s pre-grant publication US 2023/0324426), and equivalents thereof.
2) A combination of a gripper mechanism, lid opening mechanism, vertical drive motor and a horizontal drive motor, and equivalents thereof (see pars.[0056,0058,0059], for example), and wherein the components of the lid opening mechanism and gripper mechanism are as discussed in pars.[0058,0059].
3)The structure as seen in pars.[0052,0053], for example, 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.
The recitations to “abnormal or failed state” in the claims are construed as equivocal to one another, and this is seen through pars.[0174,0184] of Applicant’s pre-grant publication US 2023/0324426 in which both of terms abnormal and failed refer to “halt of the analyzer under analysis.”
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 16-18, 22, and 24-28 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.
The “reference member” is indefinitely defined by way of the recitations to “a concave surface indicating…” and “a convex surface indicating…” in independent claims 16 and 17.
Given the qualification that the reference member (as in both of cls. 16&17) is “provided in one unit of the reagent loading unit and the reagent transport unit,” the provision of the reference member being a “concave surface” is indefinitely understood.
Even assuming the base structural medium for this surface (i.e. a surface does not exist absent a base medium therefor) is given to the reagent loading unit or the reagent transport unit, that merely describes the reagent loading unit or the reagent transport unit and does not set forth a reference member provided in one of these units.
For example, does Applicant intend to recite that the reference member is a concave cutout/indentation/protrusion/etc within a surface of one of these units?
And likewise with respect to “convex surface.”
Further, as in independent cls. 16&17, the amended recitation to “wherein the distance measured…is a vertical distance from the standby position…” is indefinitely understood herein.
Initially, the recitation “the standby position” lacks proper antecedent basis in the claims, wherein it is thus unclear what particular starting position is utilized in assessing a distance.
Further, and as previously discussed in the Office Action mailed on August 28th, 2025, the term “vertical distance,” is a relative term which renders the claim indefinite. The terms not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Applicant needs to particularly define the relative spatial confines of the automatic analyzer in order to establish the sought distances and pathways. The claimed automatic analyzers are without particular discussion as to spatial orientation and functionality of the transport unit that affords a desired X-Y-Z movement within different planes in which the reagent storage unit and reagent transport unit and the positioned reference member reside, and with respect to what defines “the standby position.”
Examiner further notes that discussion to “a standby position” does not remedy this or particularly establish what is “vertical” as “a standby position” is merely a general point in three-dimensional space of the reagent transport unit.
This likewise follows in the subsequent controller configuration as recited in claims 16 and 17 as it pertains to this vertical distance and the standby position which are assessed at a plurality of times.
Further, and coincident with the above-discussed issue of clarity with the “vertical distance from the standby position,” the recitation of claim 22 is indefinitely defined in the configuration of the controller to “adjust a vertical travel distance…based on the vertical distance from the standby position to the reference member.”
Lastly, and pertaining to similar discussion previously provided with respect to indefiniteness of claims 23-26 (claim 23 now canceled and incorporated into independent cls. 16&27), Examiner reasserts that this “vertical distance” and the sought movement with respect to a “transport parameter” remains indefinitely recited herein.
The claims appear to speak to assessing proper alignment and movement distances of the reagent transport unit/reagent bottle for placement of the bottle at a particular point in a processing cycle that involves all of the reagent loading unit, reagent storage unit, and reagent transport unit, however, the claims are absent any discussion to the controller being configured for actual transportation operations that move the transport unit/bottle.
The controller being “configured to adjust a transport parameter” does not affect a movement. Further, the general discussion to “transport parameter” does not necessitate a particular operation that moves the reagent transport unit/reagent bottle a certain distance within the confines of the claim. Further, and coincident therewith this “vertical distance” measured at a plurality of times, the assessment of “abnormal or failed state” is indefinitely understood as the claims do not set forth an actual goal or success (so as to provide relative comparison for an “abnormal or failed state”) in terms of this movement/distance between a reference member and the standby position relative to any one of the reagent loading unit, reagent storage unit, and reagent transport unit.
Clarification is required.
Allowable Subject Matter
Claims 16-18, 22, and 24-28 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not teach or fairly suggest, as best understood herein, an automated analyzer as recited in either of independent claims 16 and 17, as particularly recited therein, wherein the controller is configured to adjust a transport parameter of the reagent transport unit based on the position of the reference member detected by the sensor, wherein the distance measured by the sensor is a vertical distance from the standby position of the reagent transport unit to the reference member, and wherein the controller is configured to determine the distance from the standby position to the reference member detected by the sensor at a plurality of times, determine a change of the distance over time, and determine whether an abnormal or failed state of one unit of the reagent loading unit, the reagent storage unit, and the reagent transport unit occurs based on the change of the distance over time.
Response to Arguments
Applicant's arguments filed November 12th, 2025 have been fully considered but they are not persuasive.
With regards to the rejection of the claims under 35 USC 112 b/2nd, Applicant asserts that rejections are moot in light of the amendments made to the claims.
Examine asserts that for the reasons discussed above in the body of the action, the claims remain rejected under 35 USC 112 b/2nd.
Conclusion
THIS ACTION IS MADE FINAL. 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 NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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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.
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/NEIL N TURK/Primary Examiner, Art Unit 1798