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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) in the reply filed on 3/18/26 is acknowledged.
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 specimen dispensing probe in claim 1 (and dependent claims 2-7); and
a control unit in claim 1 (and dependent claims 2-7).
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.
Examiner notes that a specimen dispensing probe in claim 1 (and dependent claims 2-7) is interpreted to be any of the dispensing probes as disclosed in the specification (as originally filed) such as in paragraphs 0013-0015 and 0022), and their equivalents.
Moreover, a control unit in claim 1 (and dependent claims 2-7) is interpreted to be any of the control units disclosed in the specification such as in paragraphs 0019, 0021, 0025, 0026, and 0029, and their equivalents.
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, 2 and 4-7 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 20190151841 (hereinafter “Iwashita”).
As to claim 1, Iwashita discloses an automatic analysis device [see system in para. 0012, for example] for analyzing a specimen, comprising:
a specimen dispensing probe configured to dispense an upper layer sample of a specimen [see for example para. 0098 disclosing the pipette to be injecting into a flowpath (thus showing the pipette is configured to dispense], that is separated into the upper layer sample and a lower layer sample, from a specimen container storing the specimen into a reaction container [see for example para. 0085 disclosing a pipette chip that is positioned in a liquid injection section, wherein the pipette chip is capable of sucking liquid];
and a control unit configured to control an operation of the specimen dispensing probe [see para. 0012 disclosing a pipette controller that causes the pipette to perform injection and suction multiple times; see also para. 0098 disclosing the same],
wherein the control unit causes the specimen dispensing probe to remove a part of a surface layer of the upper layer sample or apply a vibration to the surface layer of the upper layer sample, and then dispense the upper layer sample from the specimen container to the reaction container for a specific test [see for example para. 0091 disclosing that the liquid in the liquid injection section may be sucked into pipette chip while pipette chip is moved toward the bottom of liquid injection section]. (Examiner notes that paragraph 0091 shows that that the pipette chip is controlled such that liquid is sucked into the pipette chip towards the top of the liquid injection section, and thus is the pipette chip is capable of removing a part of a surface layer of the upper layer sample. Also, the Iwashita pipette controller is capable of performing injection and suction multiple times (see para. 0012 and 0098). Examiner notes that the injection and suction multiple times is equivalent to the repeat of the aspirating and discharging which would apply a vibration to the surface layer of the liquid.
As to claim 2, Iwashita discloses that the control unit causes the specimen dispensing probe to remove the upper layer sample of an amount exceeding a threshold value from the surface layer, and then dispense the upper layer sample [capable of being used] for the specific test. See paragraph 0012 and 0098 disclosing a controller to control the pipette chip; and see paragraph 0091 disclosing the control of the pipette chip. Examiner notes that a threshold value is not specified in claim 2, and thus the disclosure by Iwashita meets the limitations of claim 2 as discussed above.
Applicant’s claim 4 recites that the part of the upper layer sample removed from the surface layer is used for a test other than the specific test. Examiner notes that claim 4 is directed to a device, and these limitations of claim 4 including use of the control unit and dispensing probe for performing tests, is interpreted to be an intended use. The Iwashita device is capable of performing the intended use since it is capable of removing an upper layer of liquid (see discussion of claim 1 above).
Applicant’s claim 5 recites that the specific test is measurement of a lactate dehydrogenase or an alkaline phosphatase. Examiner notes that claim 5 is directed to a device, and these limitations of claim 5 including use of the control unit and dispensing probe for performing test, is interpreted to be an intended use. The Iwashita device is capable of performing the intended use since it is capable of removing and dispensing any liquid reagents into a reaction vessel (see discussion of claim 1 above).
Applicant’s claim 6 recites that the control unit causes the specimen dispensing probe to repeat aspirating and discharging with respect to the surface layer so as to apply a vibration to the surface layer, and then dispense the upper layer sample for the specific test. As discussed above regarding claim 1, the Iwashita pipette controller is capable of performing injection and suction multiple times (see para. 0012 and 0098). Examiner notes that the injection and suction multiple times is equivalent to the repeat of the aspirating and discharging which would apply a vibration to the surface layer of the liquid. The Iwashita pipette is capable of aspirating an upper layer sample. Any of the subsequent discharging is equivalent to the dispensing the upper layer sample.
Applicant’s claim 7 recites that the control unit causes the specimen dispensing probe to repeat lowering and raising to come into contact with the surface layer a plurality of times so as to apply a vibration to the surface layer, and then dispense the upper layer sample for the specific test.
See Iwashita in paragraph 0085 disclosing that the pipette placed in an injection section, the position is sensed, and the pipette is moved downward, with this operation being repeated until the desired threshold. See paragraph 0086 disclosing that the pipette is moved upwards. Thus the Iwashita pipette is capable of being moved upward and downward, repeatedly, thus meeting Applicant’s claim. Also the Iwashita pipette is capable of aspirating an upper layer sample. Any of the subsequent discharging is equivalent to the dispensing the upper layer sample.
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.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20190151841 (hereinafter “Iwashita”).
Applicant’s claim 3 recites that the threshold value is set based on a depth of a suspended matter floating in the surface layer of the upper layer sample and an inner diameter of the specimen container. Providing the Iwashita pipette controller such that the pipette chip removes an amount of liquid sample as recited falls within a workable range of the Iwashita invention. Moreover, it would have been predictable by one skilled in the art that setting the threshold value for removing the liquid sample as recited would remove a desired amount of liquid sample for a particular assay.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/Primary Examiner, Art Unit 1678