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:
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 chip to be injecting into a flowpath [thus showing the pipette is configured to dispense] [Examiner notes that pipette chip is equivalent to Applicant’s dispensing probe], 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; Examiner notes that the pipette chip is capable of performing the recited intended use];
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 chip 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 so as to suppress mixing of a suspended matter floating in the surface layer into the upper layer sample to be dispensed, 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 [equivalent to Applicant’s specimen dispensing probe] and that the pipette chip is capable of moving up and down in the 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 the pipette chip is capable of removing a part of a surface layer of the upper layer sample. In any case, Applicant’s claims are directed to a device, and the Iwashita device meets Applicant’s claims since it is capable of removing a part of a surface layer of the upper layer sample [depending on use, e.g., where the fluid sample is located]. 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 and be capable of suppressing mixing of a suspended matter floating in the surface layer into the upper layer sample.
Examiner notes the Applicant’s paragraph 0033 discloses the following.
“In Embodiment 1, the removal of a part of the surface layer of the upper layer sample A prior to dispensing of the specimen for the specific test is described. In order to suppress the adhering of the suspended matter D to the outer walls of the specimen dispensing probes 11a, 12a, the specimen may be dispensed for the specific test after the suspended matter D floating in the surface layer of the upper layer sample A is settled. In Embodiment 2, the settling of the suspended matter D by applying a vibration to the surface layer of the upper layer sample A prior to dispensing the specimen for a specific test will be described. Since a difference from Embodiment 1 is a flow of a process, the description of other contents is omitted.” Para. 0033.
The Iwashita pipette chip, as a pipette that can aspire, is capable of removing a part of the surface layer of the upper layer, which thus meets Applicant’s claim 1.
Moreover, Applicant’s paragraph 0041 discloses the following.
“The control unit 20 causes each of the specimen dispensing probes 11a, 12a to operate to repeat the aspirating and discharging of the upper layer sample A in the specimen container 15. The upper layer sample A to be aspirated is the surface layer in which the suspended matter D floats. By repeating the aspirating and discharging of the surface layer of the upper layer sample A in the specimen container 15, the vibration is applied to the surface layer of the upper layer sample A, and the suspended matter D floating in the surface layer is settled. Para. 0041 (emphasis added).
The Iwashita device, which allows for the pipette to repeat the aspiration and dispensing [i.e., discharging], is capable of performing the intended use of applying a vibration to the surface layer of the upper layer sample so as to suppress mixing of a suspended matter floating in the surface layer into the upper layer sample to be dispensed.
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.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
Applicant disagrees that “specimen dispensing probe” or “control unit” invokes 35 USC 112 (f). Applicant states that the language itself recites structural context: the “specimen dispensing probe” is a probe for dispensing a specimen form a specimen container to a reaction container, and the “control unit” is recited in the context of an automated analysis device as a controller for controlling operation of that probe. Applicant asserts that these terms are not mere placeholders, but denote classes of structures understood by persons of ordinary skills in the automatic analyzer art.
Applicant asserts that “control unit” is not claimed as a generic “unit for” performing an abstract result, but rather recites [specific control operations, as recited in claim 1].
Alternatively, Applicant asserts even assuming arguendo that 112(f) applies, the specification discloses corresponding structure linked to the claimed functions. The corresponding structure includes at least control unit 20, implemented as dedicated hardware such as an ASIC or FPGA, or as a computer including an MPU executing software, together with specimen dispensing probes 11a and 12a connected to specimen syringe 18 and movable horizontally and vertically. The specification further discloses the operative control sequence corresponding to the claimed function.
These arguments are not persuasive since the limitations claimed are generic regarding structure and recite functions of the generic structure, thus invoking 35 USC 112(f). The details described in the specification mentioned above by Applicant are not recited in the claims themselves. Rather the claims recite generic structure, followed by function.
Moreover, Applicant argues that the rejection does not identify a consistent mapping in Iwashita for the claimed “specimen container”, “reaction container” and pre-dispensing treatment of the surface layer of the upper layer sample. Applicant argues that if Iwashita’s liquid chip wells are treated as the alleged specimen container, the Iwashita does not disclose that a specimen in such a well is separated into an upper layer sample and a lower layer sample, does not disclose suspended matter floating in a surface layer of the upper layer sample in that well, and does not disclose controlling the pipette chip to remove or vibrate that surface layer before dispensing the upper layer sample to a reaction container. Applicant also argues that if the injection section 45 or flow path 44 is treated as the location where repeated suction/injection occurs, that structure is part of the reaction chip itself, not a specimen container storing a separated specimen from which an upper layer sample is dispensed into a reaction container.
Examiner notes that the Iwashita pipette chip is equivalent to Applicant’s specimen dispensing probe. The Iwashita pipette chip is capable of performing the recited intended use and thus meets Applicant’s claims.
Examiner notes that Applicant’s paragraph 0033 discloses the following.
“In Embodiment 1, the removal of a part of the surface layer of the upper layer sample A prior to dispensing of the specimen for the specific test is described. In order to suppress the adhering of the suspended matter D to the outer walls of the specimen dispensing probes 11a, 12a, the specimen may be dispensed for the specific test after the suspended matter D floating in the surface layer of the upper layer sample A is settled. In Embodiment 2, the settling of the suspended matter D by applying a vibration to the surface layer of the upper layer sample A prior to dispensing the specimen for a specific test will be described. Since a difference from Embodiment 1 is a flow of a process, the description of other contents is omitted.” Para. 0033.
The Iwashita pipette chip, as a pipette that can aspire, is capable of removing a part of the surface layer of the upper layer, which thus meets Applicant’s claim 1. Examiner notes that Applicant is claim a device (rather than a method), and therefore if the prior art device is capable of performing the recited intended use, the prior art meets the claims.
Moreover, Applicant’s paragraph 0041 discloses the following.
“The control unit 20 causes each of the specimen dispensing probes 11a, 12a to operate to repeat the aspirating and discharging of the upper layer sample A in the specimen container 15. The upper layer sample A to be aspirated is the surface layer in which the suspended matter D floats. By repeating the aspirating and discharging of the surface layer of the upper layer sample A in the specimen container 15, the vibration is applied to the surface layer of the upper layer sample A, and the suspended matter D floating in the surface layer is settled. Para. 0041 (emphasis added).
The Iwashita device, which allows for the pipette to repeat the aspiration and dispensing [i.e., discharging], is capable of performing the intended use of applying a vibration to the surface layer of the upper layer sample so as to suppress mixing of a suspended matter floating in the surface layer into the upper layer sample to be dispensed.
Applicant also argues that although Iwashita may refer generally to a specimen liquid, Iwashita does not disclose the claimed specimen that is separate in a specimen container into an upper layer sample and a lower layer sample, nor suspended matter floating in a surface layer of such an upper layer sample. Applicant argues that the mere disclosure of a specimen liquid is not a disclosure of a separated specimen having an upper layer sample, lower layer sample, and suspended matter floating in the surface layer of the upper layer sample. Applicant argues that anticipation cannot be based on an undisclosed hypothetical use of Iwashita’s device.
Applicant’s arguments are not persuasive. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Iwashita device is capable of performing the intended use as explained above.
Applicant has also amended the claims and asserts that Iwashita does not teach or suggest the claimed limitations.
Specifically, claim 1 has been amended to recite that
“the control unit is configured to cause 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 so as to suppress mixing of a suspended matter floating in the surface layer into the upper layer sample to be dispensed”.
Iwashita meets Applicant’s limitations. See for example paragrap 0091 disclosing that the liquid in the liquid injection section may be sucked into pipette chip [equivalent to Applicant’s specimen dispensing probe] and that the pipette chip is capable of moving up and down in the 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 the pipette chip is capable of removing a part of a surface layer of the upper layer sample. In any case, Applicant’s claims are directed to a device, and the Iwashita device meets Applicant’s claims since it is capable of removing a part of a surface layer of the upper layer sample [depending on use, e.g., where the fluid sample is located]. 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 and be capable of suppressing mixing of a suspended matter floating in the surface layer into the upper layer sample.
Examiner emphasizes that Applicant’s claims are directed to a device (rather than a method), and the device of Iwashita meets Applicant’s claims since it has the structures of the claimed device and is capable of performing the device, as discussed above.
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 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
