DETAILED ACTION
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 claims 1-9 and 15-20 in the reply filed on 12 Nov. 2025 is acknowledged.
Claim Interpretations - 35 USC § 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.
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 collection unit configured to collect soluble iron contained in a sample” in claim 1, with the generic placeholder “unit”, the function of “collect”, and no structural modifier. The corresponding structure in the specification ¶32 is a three-way valve, a second three-way valve, and a cartridge.
“a reaction unit configured to produce a reaction solution” in claim 1, with the generic placeholder “unit”, the function of “produce”, and no structural modifier. The corresponding structure in the specification ¶36 is a reaction vessel.
“a detection unit configured to detect an absorbance of the reaction solution” in claim 1, with the generic placeholder “unit”, the function of “detect”, and no structural modifier. The corresponding structure in the specification ¶39 is an optical absorbance detector.
“a supply control unit configured to supply the soluble iron collected in the collection unit and a reagent to the reaction unit” in claim 1, with the generic placeholder “unit”, the function of “supply”, and no structural modifier. The corresponding structure in the specification ¶47 is a controller for the reagent and samples.
“a regeneration control unit configured to supply” in claim 4, with the generic placeholder “unit”, the function of “supply”, and no structural modifier. There is no corresponding structure in the specification.
“estimation unit configured to estimate” in claim 5, with the generic placeholder “unit”, the function of “estimate”, and no structural modifier. There is no corresponding structure in the specification.
“a washing control unit configured to supply the pure water” in claim 8, with the generic placeholder “unit”, the function of “supply”, and no structural modifier. The corresponding structure in the specification ¶54 is a pipe.
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(b)
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.
Claim 5 is 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 limitation
“a regeneration control unit configured to supply” in claim 4;
“estimation unit configured to estimate” in claim 5;
invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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.
Claims 1-5, 8-9, and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shinichi et al. WO2019087762 published 9 May. 2019 as translated by US20200155996 (hereafter Shinichi).
Regarding claim 1, Shinichi teaches an analysis system (Fig 2) comprising:
a collection unit (a three-way valve V21, V24, V22; a second three-way valve V20, V16, V19; and a cartridge 441) configured to collect soluble iron contained in a sample (¶39);
a reaction unit (reaction vessel 451 and/or 421) configured to produce a reaction solution (¶41, ¶421);
a detection unit (an optical absorbance detector 452) configured to detect an absorbance of the reaction solution (¶42); and
a supply control unit (a controller for the reagent and samples 60) configured to supply the soluble iron collected in the collection unit and a reagent to the reaction unit (¶43).
Regarding claim 2, Shinichi teaches all the limitations of claim 1. Shinichi further teaches wherein the collection unit collects the soluble iron with a solid phase extractant using a chelating resin (¶56-59).
Regarding claim 3, Shinichi teaches all the limitations of claim 1. Shinichi further teaches
a sample supply tube (tube to P07) through which the sample is supplied to the collection unit; and
an eluate supply tube (tube to V16) through which an eluate is supplied to the collection unit, wherein
the supply control unit supplies the sample to the collection unit through the sample supply tube, then sends the eluate to the collection unit through the eluate supply tube, and supplies the eluate and the soluble iron to the reaction unit (where the configuration of conduits, valves, etc is fully capable of performing the function, see MPEP 2114, 2115, 2173.05(g)).
Regarding claim 4, Shinichi teaches all the limitations of claim 2. Shinichi further teaches an alkaline solution supply tube (tube with V03) through which an alkaline solution is supplied to the collection unit; and a regeneration control unit (unit with V14) configured to supply the soluble iron to the reaction unit, and then supply the alkaline solution to the collection unit.
Regarding claim 5, Shinichi teaches all the limitations of claim 1. Shinichi further teaches an estimation unit configured to estimate an iron concentration in the sample based on the absorbance detected (¶42).
Regarding claim 8, Shinichi teaches all the limitations of claim 1. Shinichi further teaches a pure water tank storing pure water (waters supplied via pump P03 and/or P08, where one of ordinary skill would know that a tank to store the pure water would be used); a pure water supply pipe (pipe with pump P03 and/or pipe with pump P08) through which the pure water is supplied from the pure water tank to one of the reaction unit and the detection unit or both; and a washing control unit (pipe with valve V04 and/or V27) configured to supply the pure water to one of the reaction unit and the detection unit or both through the pure water supply pipe.
Regarding claim 9, Shinichi teaches all the limitations of claim 1. Shinichi further teaches a reference solution tank storing a reference solution, whose iron concentration is adjusted in advance; and a calibration control unit configured to calibrate the detection unit based on the reaction solution obtained by mixing the reference solution and the reagent (¶78-80, where one of ordinary skill in the art would understand that a tank would be used for the reference solution in order to store the solution until needed)
Regarding claim 15, Shinichi teaches all the limitations of claim 2. Shinichi further teaches
a sample supply tube (tube to P07) through which the sample is supplied to the collection unit; and
an eluate supply tube (tube to V16) through which an eluate is supplied to the collection unit, wherein
the supply control unit supplies the sample to the collection unit through the sample supply tube, then sends the eluate to the collection unit through the eluate supply tube, and supplies the eluate and the soluble iron to the reaction unit (where the configuration of conduits, valves, etc is fully capable of performing the function, see MPEP 2114, 2115, 2173.05(g)).
Regarding claim 16, Shinichi teaches all the limitations of claim 2. Shinichi further teaches an estimation unit configured to estimate an iron concentration in the sample based on the absorbance detected (¶42).
Regarding claim 17, Shinichi teaches all the limitations of claim 3. Shinichi further teaches an estimation unit configured to estimate an iron concentration in the sample based on the absorbance detected (¶42).
Regarding claim 18, Shinichi teaches all the limitations of claim 4. Shinichi further teaches an estimation unit configured to estimate an iron concentration in the sample based on the absorbance detected (¶42).
Regarding claim 19, Shinichi teaches all the limitations of claim 15. Shinichi further teaches an estimation unit configured to estimate an iron concentration in the sample based on the absorbance detected (¶42).
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Shinichi as applied to claim 1 above, and further in view of “PHD Ultra Syringe Pump Series User’s Guide” published 2 Apr. 2012 accessed at <https://www.harvardapparatus.com/media/manuals/Product%20Manuals/PHD%20ULTRA%20Manual-70-3xxx_5419-002REV1.0.pdf> (hereafter Syringe).
Regarding claim 6, Shinichi teaches all the limitations of claim 1. Shinichi further teaches a pump (P07) configured to suck liquid into a vessel (pump body) and send a predetermined amount (amount pumped) of the liquid from the vessel, wherein the supply control unit controls the pump to send the sample to the collection unit (¶43).
Shinichi does not teach where the pump is a syringe pump.
Syringe teaches where a syringe pump is a high accuracy pump (page 10).
Applicant is reminded of the duty to disclose, as recited in MPEP §609: “In nonprovisional applications, applicants and other individuals substantively involved with the preparation and/or prosecution of the application have a duty to submit to the Office information which is material to patentability as defined in 37 CFR 1.56."
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump (P07) of Shinichi by using the syringe pump (page 10) of Syringe because of the high accuracy (page 10).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Shinichi as applied to claim 1 above.
Regarding claim 7, Shinichi teaches all the limitations of claim 1. Shinichi further teaches a supply of nitrogen (via valve V25) to the reaction unit (451) where the supply control unit controls the operation of the system (¶43).
The Shinichi system would have been fully capable of supplying air, where air is mostly nitrogen. See MPEP 2114, 2115, 2173.05(g).
Shinichi does not teach a pump configured to supply air to the reaction unit, wherein the supply control unit makes the pump supply the air to the reaction unit, causing air bubbling to stir the soluble iron and the reagent.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the supply (via valve V25)of Shinichi by using a pump where a pump provides a driving means to the fluid to transport and/or pressurize the fluid.
The Shinichi system would have been fully capable of the supply control unit makes the pump supply the air to the reaction unit, causing air bubbling to stir the soluble iron and the reagent, where the air/nitrogen is supplied below the liquid surface as shown in Fig 2. See MPEP 2114, 2115, 2173.05(g).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Shinichi as applied to claim 2 above, and further in view of “PHD Ultra Syringe Pump Series User’s Guide” published 2 Apr. 2012 accessed at <https://www.harvardapparatus.com/media/manuals/Product%20Manuals/PHD%20ULTRA%20Manual-70-3xxx_5419-002REV1.0.pdf> (hereafter Syringe).
Regarding claim 20, Shinichi teaches all the limitations of claim 2. Shinichi further teaches a pump (P07) configured to suck liquid into a vessel (pump body) and send a predetermined amount (amount pumped) of the liquid from the vessel, wherein the supply control unit controls the pump to send the sample to the collection unit (¶43).
Shinichi does not teach where the pump is a syringe pump.
Syringe teaches where a syringe pump is a high accuracy pump (page 10).
Applicant is reminded of the duty to disclose, as recited in MPEP §609: “In nonprovisional applications, applicants and other individuals substantively involved with the preparation and/or prosecution of the application have a duty to submit to the Office information which is material to patentability as defined in 37 CFR 1.56."
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pump (P07) of Shinichi by using the syringe pump (page 10) of Syringe because of the high accuracy (page 10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN HOBSON whose telephone number is (571)272-9914. The examiner can normally be reached 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dieterle can be reached at 571-270-7872. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/STEPHEN HOBSON/Examiner, Art Unit 1776