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’s filing of claims 1-8 on 1/31/24 is acknowledged. Claims 1-8 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 1/31/24 and 7/23/25 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation under 35 U.S.C. 112(f)
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: dispensing mechanism configured to, cleaning unit configured to, and a control unit configured to in claims 1 and 4.
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 Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
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.
Claims 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oonuma et al. (“Oonuma,” US Pub. No. 2007/0175284, cited in IDS).
As to claim 1, Oonuma discloses in automatic analysis device in fig. 4 comprising: a dispensing mechanism in fig. 1 configured to aspirate and discharge a specimen; a cleaning unit configured to clean the dispensing mechanism; and a control unit configured to determine whether to perform additional cleaning in addition to normal cleaning performed at each dispensing, wherein the control unit is configured to perform the determination based on a use of a pre-specimen dispensed before a post-specimen to be dispensed by the dispensing mechanism. See e.g., [0049] et seq.
As to claim 2, Oonuma discloses a type of a control specimen of the pre-specimen, the control unit is configured to determine necessity or non-necessity of the additional cleaning in e.g., [0048] et seq.
As to claim 3, Oonuma discloses a type of calibrator of the pre-specimen, the control unit is configured to determine necessity or non-necessity of the additional cleaning in e.g., [0048] et seq.
As to claim 4, Oonuma discloses an automatic analysis device comprising: a dispensing mechanism configured to aspirate and discharge a specimen; a cleaning unit configured to clean the dispensing mechanism; and a control unit configured to determine whether to perform additional cleaning in addition to normal cleaning performed at each dispensing, wherein the control unit is configured to perform the determination based on the number of times a pre-specimen dispensed before a post-specimen to be dispensed by the dispensing mechanism is dispensed, and the number of times of dispensing is the number of times the same pre-specimen is dispensed after a dispensing target is switched to the pre-specimen. See fig. 1 et seq. and [0035] et seq.
As to claim 5, Oonuma discloses the control unit is configured to determine a predetermined pattern from a plurality of cleaning patterns related to the additional cleaning in e.g., [0040] et seq.
As to claim 6, Oonuma discloses the control unit is configured to determine whether to perform the additional cleaning in consideration of a test item of the post-specimen in e.g., [0040] et seq.
As to claim 7, Oonuma discloses the post-specimen is dispensed a plurality of times and is used for another test item, the additional cleaning is performed before first dispensing of the post-specimen when a test item on which the additional cleaning is to be performed is included in e.g., [0040] et seq.
As to claim 8, Oonuma teaches an automatic analysis method comprising: a dispensing step of aspirating and discharging a specimen by a dispensing mechanism; a normal cleaning step of cleaning the dispensing mechanism at each dispensing; and an additional cleaning step of performing an additional cleaning when a control unit determines necessity of the additional cleaning, wherein the control unit is configured to determine necessity or non-necessity of the additional cleaning based on a use of a pre-specimen dispensed before a post-specimen to be dispensed by the dispensing mechanism or the number of times the same pre-specimen is dispensed after a dispensing target is switched to the pre-specimen. See e.g., [0035] et seq.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to 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, Lyle Alexander can be reached at 571-272-1254.
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.
/LORE R JARRETT/Primary Examiner, Art Unit 1797
6/27/2026
Prosecution Insights