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 .
Specification
The abstract of the disclosure is objected to because the abstract spans multiple paragraphs and exceeds the maximum allowable limit of 150 words. Please see the additional information provided below. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 9 and 16 are objected to because of the following informalities:
As for claim 9, in lines 4-5 of the claim, the phrase “in which a component is same as a component” should be amended to read “in which a component is the same as a component”.
As for claim 16, in lines 5-6 of the claim, the phrase “in which a component is same as a component” should be amended to read “in which a component is the same as a component”.
Appropriate correction is required.
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:
“An absorbance measurement unit configured to measure absorbance . . .” in claims 1-12 (for claims 13 and 14, please see the 35 USC 112(b) rejection set forth below).
“A calibration curve creation unit configured to create a calibration curve . . .” in claims 9-12.
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.
The examiner notes that “control unit” and “detection unit” are not being interpreted under 35 USC 112(f), as the examiner considers these to be terms known to denote structure in the art.
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 9-14 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 calibration curve creation unit” in claims 9-12 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.
As “a calibration curve creation unit” in claims 9-12 invokes 35 USC 112(f), the examiner turns to the specification to ascertain what structure corresponds to this unit. However, no specific structure appears to be found that corresponds to the unit. The specification only appears to further describe this unit using the language by which it is claimed – a calibration curve creation unit (see element 7 in Figure 5). While the unit appears to be some kind of processor due to the disclosure of an algorithm for the creation of the calibration curve starting with paragraph 0059 on page 27 of the specification, the algorithm itself is not sufficient to impart structure to the limitation without the specific hardware (see MPEP 2181 II. B.; the structure needs to include both the algorithm and the computer or microprocessor that is programmed with the algorithm). While the specification discloses that the control unit 6 of the instant application is a computer that implements the function of the control unit (see Figure 14 and the corresponding description), this computer does not appear to be directly tied to the calibration curve creation unit in order to provide the needed structure for the limitation.
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.
As for claim 13, the claim, which recites further elements of claim 1 including a light source, a light-transmissive container, and a detection unit. However, claim 1, the claim on which claim 13 depends, recites “an absorbance measurement unit” which, when turning to the instant specification, includes a light source 41, 49, a light-transmissive container 43, and a detection unit 48. As a result, it is unclear if the elements set forth in claim 13 are in addition to the elements of the absorbance measurement unit of claim 1, or if these are the elements that make up the absorbance measurement unit as is clear from the instant specification. Clarification is required. For purposes of examination below, the examiner will interpret these features as being part of the absorbance measurement unit.
Claim 14 is rejected by virtue of its dependence on claim 13, thereby containing all the limitations of the claim on which it depends.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 9-12 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 9-12, the claims are rejected for a lack of written description for the reasons set forth above regarding 35 USC 112(b) and indefiniteness. The rejection is made because an indefinite, unbounded limitation would cover all structure that can perform the claimed function. Because the specification has not clearly defined structure for the claimed calibration curve creation unit, this indicates that applicant has not provided sufficient disclosure to show possession of the invention.
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 1-13 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Higashi et al (2013/0048215).
Regarding claim 1, Higashi (Figs. 1 and 2) discloses a concentration measurement device comprising an absorbance measurement unit 7 (concentration sensing means, the details of which are disclosed in Fig. 2; see also paragraph 0055) configured to measure absorbance (“measuring the absorbance characteristics of the processing liquid” in paragraph 0055) in a plurality of different wavelength regions for a mixed liquid in which different liquids are mixed (the light source is disclosed to be a lamp that has a wavelength around 800 to 1600 nm, with specific wavelengths used for measuring various aspects of the solution such as water or phosphoric acid; see paragraphs 0070 and 0071); and a control unit 8 (concentration controlling means) configured to correct a concentration of at least one liquid on a basis of absorbance in the plurality of different wavelength regions (see paragraph 0090, which describes the concentration controlling means as adjusting the amount of replenishment with water in order to make the concentration sensed by the concentration sensing means come close to the set concentration on the basis of the sensed concentration of the phosphoric acid solution).
As for claim 2, Higashi discloses that the absorbance measurement unit measures absorbance in two wavelength regions (see paragraph 0071; the measurement of absorption at 980 nm and 1100 nm).
As for claim 3, Higashi discloses that the absorbance measurement unit measures absorbance in a spectrum (Higashi discloses performing infrared spectroscopy in paragraph 0073).
As for claims 4-6, Higashi inherently discloses the additional limitations found in the claims that the particles contained in one of the different liquids are different from particles contained in another of the different liquids (claim 4), wherein each of the different liquids includes a suspension or solution (claim 5), and wherein the mixed liquid includes a white blood cell suspension and a red blood cell suspension (claim 6). This is because in a situation where the structure recited in the reference is substantially identical to that of the claims, the claimed functions are presumed to be inherent. See MPEP 2112.01 and In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). In the instant case, because Higashi discloses the concentration measurement device as set forth above regarding claim 1, that device is inherently capable of measuring a different solution and solutions containing particles such as red and white blood cells as set forth in claims 4-6, and as evidenced by the teachings of US 2016/0377634 to Ochiai which discloses absorbance measurement of such samples (see paragraphs 0038-0039 describing the liquid as blood, with the blood including white and red blood cells as in paragraph 0053, and the measurement being absorbance at a variety of wavelengths as in the abstract and paragraphs 0050-0052).
As for claim 7, Higashi discloses that the control unit calculates a mixing ratio of a liquid mixed in the mixed liquid from absorbance in the plurality of different wavelength regions (see paragraph 0090, “Specifically, the concentration controlling means 8 operates the flow rate adjustment valve 6b by the PID (proportion, integration, differentiation) control on the basis of the sensed concentration of the phosphoric acid solution. For example, control is made in such a manner that, when the sensed concentration of the processing liquid is above the set concentration, replenishment with the diluent is made, whereas when the sensed concentration of the processing liquid is below the set concentration, replenishment with the diluent is stopped”).
As for claim 8, Higashi discloses that the control unit corrects the absorbance on a basis of a mixing ratio of a liquid mixed in the mixed liquid (see paragraph 0090, “Specifically, the concentration controlling means 8 operates the flow rate adjustment valve 6b by the PID (proportion, integration, differentiation) control on the basis of the sensed concentration of the phosphoric acid solution. For example, control is made in such a manner that, when the sensed concentration of the processing liquid is above the set concentration, replenishment with the diluent is made, whereas when the sensed concentration of the processing liquid is below the set concentration, replenishment with the diluent is stopped”).
As for claim 9, Higashi further discloses a calibration curve creation unit (microprocessor 132; see paragraph 0082 how the microprocessor is used to determine the calibration line formula) configured to create a calibration curve (calibration line formula; see paragraphs 0065-0066 and 0082) by using a calibration-curve-creation mixed liquid in which a component is the same as a component of the mixed liquid and a concentration of each mixed liquid is known (see paragraph 0066 for the discussion of how the calibration line formula is determined).
As for claim 10, Higashi discloses that the calibration curve creation unit creates a calibration curve for obtaining a concentration of at least one mixed liquid on a basis of absorbance in a specific wavelength region by using the calibration-curve-creation mixed liquid in which a concentration of the at least one liquid is known (see paragraph 0066, “introducing a sample of a phosphoric acid solution having a known concentration”)).
As for claim 11, Higashi discloses that the calibration curve creation unit creates a calibration curve for obtaining a mixing ratio of a liquid mixed in the mixed liquid on a basis of a difference in absorbance in the plurality of different wavelength regions (see paragraph 0066, “allowing light having a different wavelength in an infrared wavelength region to be transmitted through the cell or the like, measuring an intensity value of the transmitted light, repeating this measurement for a plurality of samples, and calculating the absorbance from the intensity value of the above plurality of samples”).
As for claim 12, Higashi discloses that the calibration curve creation unit creates a calibration curve for obtaining absorbance on a basis of a mixing ratio of a liquid mixed in the mixed liquid (see paragraph 0066, “introducing a sample of a phosphoric acid solution having a known concentration”).
As for claim 13, Higashi further discloses a light source 100 configured to emit light (see paragraph 0070); a light-transmissive container 151 inside of which a fluid containing the mixed liquid flows (see paragraph 0055); and a detection unit 118 configured to detect light having passed through the container (see paragraph 0075).
Regarding claim 15, Higashi (Figs. 1 and 2) discloses a concentration measurement method comprising an absorbance measuring step of measuring absorbance (“measuring the absorbance characteristics of the processing liquid” in paragraph 0055) using concentration sensing means 7 (the details of which are disclosed in Fig. 2; see also paragraph 0055) in a plurality of different wavelength regions for a mixed liquid in which different liquids are mixed (the light source is disclosed to be a lamp that has a wavelength around 800 to 1600 nm, with specific wavelengths used for measuring various aspects of the solution such as water or phosphoric acid; see paragraphs 0070 and 0071); and a correction step of correcting a concentration using concentration controlling means 8 of at least one liquid on a basis of absorbance in the plurality of different wavelength regions (see paragraph 0090, which describes the concentration controlling means as adjusting the amount of replenishment with water in order to make the concentration sensed by the concentration sensing means come close to the set concentration on the basis of the sensed concentration of the phosphoric acid solution).
As for claim 16, Higashi further discloses a calibration curve creating step of creating a calibration curve (calibration line formula; see paragraphs 0065-0066 and 0082) by using a calibration-curve-creation mixed liquid in which a component is the sesame as a component of the mixed liquid and a concentration of each mixed liquid is known (see paragraph 0066 for the discussion of how the calibration line formula is determined).
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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Higashi et al (2013/0048215) in view of Kiuchi et al (2003/0052272).
As for claim 14, Higashi discloses the claimed invention as set forth above regarding claim 13, but fails to disclose that the light source includes a first light source emitting light having a first wavelength and a second light source emitting light having a second wavelength different from the first wavelength.
Kiuchi, in a concentration detection system that measures infrared absorbance (see paragraph 0018 for example) discloses an optical system 3 (see Fig. 1) that includes a first light source 4A and a second light source 6A where the wavelengths of each light source are different (a central wavelength range of 1.55 to 1.85 µm for light source 4A as in paragraph 0080 and between 1.42 and 1.48 µm for light source 6A as in paragraph 0105).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the single light source of Higashi for a pair of light sources with different wavelength bands as taught by Kiuchi, the motivation being that having explicit wavelength bands allows for easier measurement of various, differing aspects of the aqueous solution of interest (see paragraph 0017) and allows for concentrations of multiple constituents contained in the solution to be obtained as a result of using different wavelength bands (see the abstract).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US Pat. 5,510,267 to Marshall discloses measuring blood via absorbance (see Col. 7, lines 1-30); US 2005/0065750 to Yokoyama et al. discloses a method for measuring a component concentration in a solution via absorbance (see the abstract, paragraph 0038, and claim 3); and US 2021/0404950 to Li et al. discloses an optical sensor for measuring absorbance of a calibration solution at first and second wavelengths to provide multiple absorption measurements (see paragraph 0012).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael A. Lyons whose telephone number is (571)272-2420. The examiner can normally be reached Monday - Friday.
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/Michael A Lyons/Primary Examiner, Art Unit 2877 October 8, 2026
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