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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/13/2022, 09/12/2022, and 02/09/2024 has been considered by the examiner.
Election/Restrictions
Applicant's election of Species B, Claims 1-2, with traverse in the reply filed on 08/12/2025 is acknowledged.
Upon consideration of the claims and the elected species, claim 4 is drawn to elected Species B, although Applicant had withdrawn claim 4. Thus, claim 4 is also examined herein.
The traversal is on the ground(s) that “search and examination of the entire application can be made without serious search and/or examination burden”. This is not found persuasive because for purposes of the initial requirement, a serious burden on the Examiner may be prima facie shown if the Examiner shows by appropriate explanation of separate classification, or separate status in the art, or a different field of search (as defined in MPEP § 808.02). The restriction requirement clearly meets this requirement. While that prima facie showing may be rebutted by appropriate showings or evidence by the Applicant, an unsupported statement by Applicant that no serious burden would exist in the examination of all pending claims does not qualify as an “appropriate showing” or “evidence”. See MPEP § 803. As stated in the prior Office Action, the claims of the present application contain distinct inventions. A search of these inventions may overlap, but the search of one invention does not include all the areas required for the others. A serious burden does exist, as different searches are required for each invention. Therefore, in order to ensure the quality of the search and examination, these inventions should be searched separately to account for their differences.
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claims 1 and 4 are objected to because of the following informalities:
Claim 1, line 1: please amend “measures the concentration” to –measures [[the]]a concentration --.
Claim 1, line 2: please amend “on the result” to –on [[the]]a result --.
Claim 1, line 3: please amend “and the result” to –and [[the]]a result --.
Claim 1, lines 8-9: please amend “such that the absolute value of the temperature” to – such that [[the]]an absolute value of [[the]]a temperature --.
Claim 4, lines 4-5: please amend “such that the absolute value of the temperature” to – such that [[the]]an absolute value of [[the]]a temperature --.
Claim 4, line 6: please amend “smaller than the absolute value of the temperature” to – smaller than [[the]]an absolute value of [[the]]a temperature --.
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.
Claim 1, “a reagent generation unit for diluting and restoring a reagent stock solution having a concentration higher than a predetermined ion concentration with pure water to generate a reagent having the predetermined ion concentration”, is being interpreted under 35 U.S.C. 112(f). Prong 1: a reagent generation unit (uses the generic placeholder), prong 2: for diluting and restoring… (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). The corresponding structure for performing the functions is described in the specification (see e.g., Paras. [0042, 0027, 0032] and Fig. 3) such as a reagent unit 103 (which is a concentrated internal standard solution bottle 3, a diluent bottle 4, a reference electrode solution bottle 5, a degassing mechanism 6, filters 15, or a dilution and restoration unit 24) and a mechanism unit 104 (which is an internal standard solution syringe 7, the diluent syringe 8, the sipper syringe 9, or the solenoid valves 16), and equivalents thereof. The examiner notes that while the specification mentions the diluent bottle 4 as part of the reagent unit 103, it is not a part of the structure of Fig. 3 and thus suggests a concentrated internal standard solution bottle 3, a diluent bottle 4, a reference electrode solution bottle 5, a degassing mechanism 6, filters 15, or a dilution and restoration unit 24 as alternatives-- “or”. The same reasoning of alternative structures is applied to the mechanism unit 104.
Claim 4, “a specimen dilution unit for diluting a specimen to be analyzed with pure water to generate a diluted specimen”, is being interpreted under 35 U.S.C. 112(f). Prong 1: a specimen dilution unit (uses the generic placeholder), prong 2: for diluting a specimen … (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). However, the scope of the term “specimen dilution unit” is unclear due to the specification not clearly disclosing the corresponding structure. An explanation is provided in the 35 USC 112(b) rejection below.
Claim Rejections - 35 USC § 112
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 1-2 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, because the claim purports to invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, but fails to recite a combination of elements as required by that statutory provision and thus cannot rely on the specification to provide the structure, material or acts to support the claimed function. As such, the claim recites a function that has no limits and covers every conceivable means for achieving the stated function, while the specification discloses at most only those means known to the inventor. Accordingly, the disclosure is not commensurate with the scope of the claim.
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 1-2 and 4 are 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.
Regarding claim 1, claim 1 recites “higher than a predetermined ion concentration” in line 6. However, it is unclear if the predetermined ion concentration is the same as the predetermined ion concentration recited in lines 2-3 or a different, newly recited predetermined ion concentration, such as a second predetermined ion concentration. Applicant should clarify the relationship between these two predetermined ion concentrations. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 1, claim 1 recites “a reagent” in line 7. However, it is unclear if the reagent of line 7 is the same as the reagent recited in line 2 or a different, newly recited reagent. Applicant should clarify the relationship between these two reagents. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 1, claim 1 recites the limitation "the dilution and restoration” in the last line of claim 1. There is insufficient antecedent basis for this limitation in the claim. The examiner notes that claim 2 also recites the same limitation of “the dilution and restoration”. Therefore, the scope of claim 1 is indefinite. Claims 2 and 4 are further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of claim 1.
Regarding claim 4, claim 4 recites “a specimen to be analyzed” in line 2. However, it is unclear if the specimen to be analyzed of line 2 in claim 4 is the same as “a specimen” recited in line 2 of claim 1 (on which claim 4 depends) or a different, newly recited specimen that is distinct from the specimen of claim 1. Applicant should clarify the relationship between these two specimens. Therefore, the scope of claim 4 is indefinite.
Regarding claim 4, claim 4 recites “pure water” in line 2. However, it is unclear if the pure water of line 2 in claim 4 is the same as the pure water recited in line 6 of claim 1 (on which claim 4 depends) or a different, newly recited element of pure water. Applicant should clarify the relationship between these two pure waters. Therefore, the scope of claim 4 is indefinite.
Regarding claim 4, the claim limitation “a specimen dilution unit” 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. The specification states “The specimen dispensing unit 101, the dilution tank 10 of the analysis unit 102, the reagent unit 103, and the mechanism unit 104 form a specimen dilution unit for diluting a specimen to be analyzed with a diluent to generate a diluted specimen” in Para. 0042. However, it is unclear if the reagent unit 103 and the mechanism unit 104 of the specimen dilution unit is the same or different as the reagent unit and mechanism unit included in the reagent generation unit, as claimed in claim 1 [see 112f analysis above]. Furthermore, it is unclear how other units which make up the reagent generation unit can also be included in the specimen dilution unit and what are the structures that are overlapping or different between all the claimed units. It is unclear what exactly entails the specimen dilution unit and 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 corresponding structure for performing the functional limitation is not described in the specification and without clearly linking the structure to the function and the claim is subsequently 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
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.
Claim(s) 1-2, and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kishioka et al. (WO-2018020880-A1, references herein made with respect to US equivalent US-20190265187-A1).
Regarding claim 1, an electrolyte analysis apparatus (Kishioka teaches an electrolyte concentration measurement device 400 [Abstract, Fig. 4 and Para. 0096]), the limitation “which measures the concentration of a specific ion in a specimen based on the result of measuring a reagent having a predetermined ion concentration with an ion selective electrode and the result of measuring the specimen with the ion selective electrode” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Kishioka teaches the above electrolyte concentration measurement device as shown in Fig. 4 that is specifically configured to perform the functional limitations above (Kishioka teaches measuring the concentration of a specimen and internal standard liquid by ion selective electrodes 101, 102 and 103 and the reference electrode 104 [Paras. 0127-0133 and Fig. 4-5] where the specimen to be analyzed may be serum or urine [Para. 0003, 0071] with the plurality of ion selective electrodes (ISE) corresponding to ions to be detected “specific ions” in order to simultaneously analyze a plurality of ions (sodium ions, potassium ions, calcium ions, chloride ions or the like) [Para. 0004], the electrolyte analysis apparatus which measures the concentration in the specimen based on the result of measuring the internal standard liquid [corresponding to a reagent having a predetermined ion concentration as the internal standard liquid is within a set concentration range, Para. 0124] with the ion selective electrodes and the result of measuring the specimen with the ion selective electrodes [Paras. 0124-0133 and Fig. 4-5], and thus is capable of performing the functional limitations above), comprising:
a reagent generation unit for diluting and restoring a reagent stock solution having a concentration higher than a predetermined ion concentration with pure water to generate a reagent having the predetermined ion concentration (Kishioka teaches an internal standard liquid preparation unit 440 which at least includes an internal standard liquid preparation container A441, an internal standard liquid preparation container B442, a drug substance supply unit 448 that supplies a drug substance 447 where the drug substance in a form of concentrated liquid may be used [the drug substance is in a form of concentrated liquid and corresponds to a reagent stock solution], an internal standard liquid syringe 131, electromagnetic valve 123, stirring mechanisms 443 and 444, and switching valves [electromagnetic valves 421, 422 and 423] [these structures corresponding to a reagent generation unit]. Kishioka further teaches a pure water supply pump 481 that introduces pure water into each preparation container where stirring mechanisms 443 and 444 stir and mix the drug substance 447 [the drug substance is in a form of concentrated liquid and corresponds to a reagent stock solution] and the pure water, thus diluting and restoring a reagent stock solution having a concentration higher than a predetermined ion concentration with pure water to generate a reagent/internal standard liquid having the predetermined ion concentration/set concentration range, where the internal standard liquid “reagent” is prepared by supplying pure water to the preparation container A441 using the pure water supply pump 481 while stirring by the stirring unit 443 and the prepared internal standard liquid concentration is calculated (S504) where the ion concentration of the internal standard liquid is within a set concentration range (S505) [Paras. 0096-0097, 0101-0102, 0147, 0124-0133 and Figs. 4-5]); and
the limitation “the reagent generation unit generates the reagent such that the absolute value of the temperature difference between the reagent obtained by diluting and restoring the reagent stock solution with the pure water, and the pure water is smaller than an absolute value of a temperature difference between the reagent obtained by the dilution and restoration, and the reagent stock solution” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Kishioka teaches the above reagent generation unit as outlined in the rejection above that is specifically configured to perform the functional limitations above (Kishioka teaches an internal standard liquid preparation unit 440 which at least includes an internal standard liquid preparation container A441, an internal standard liquid preparation container B442, a drug substance supply unit 448 that supplies a drug substance 447 where the drug substance in a form of concentrated liquid may be used [the drug substance is in a form of concentrated liquid and corresponds to a reagent stock solution], an internal standard liquid syringe 131, electromagnetic valve 123, stirring mechanisms 443 and 444, and switching valves [electromagnetic valves 421, 422 and 423] [these structures corresponding to a reagent generation unit]. Kishioka further teaches a pure water supply pump 481 that introduces pure water into each preparation container where stirring mechanisms 443 and 444 stir and mix the drug substance 447 [the drug substance is in a form of concentrated liquid and corresponds to a reagent stock solution] and the pure water, thus diluting and restoring a reagent stock solution having a concentration higher than a predetermined ion concentration with pure water to generate a reagent/internal standard liquid having the predetermined ion concentration/set concentration range [Paras. 0096-0097, 0101-0102, 0147, 0124-0133 and Figs. 4-5, see rejection above]). Since the prior art does disclose a reagent generation unit comprising substantially the same elements or components as that of the applicant, it is contended that the reagent generation unit of the prior art is capable of performing the functional limitations above. Accordingly, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent and cannot have mutually exclusive properties, and thus, the claimed property or function (i.e., the reagent generation unit generates the reagent such that the absolute value of the temperature difference between the reagent obtained by diluting and restoring the reagent stock solution with the pure water, and the pure water is smaller than an absolute value of a temperature difference between the reagent obtained by the dilution and restoration, and the reagent stock solution), is necessarily present in the prior art material [See MPEP 2112.01 (I)]).
Regarding claim 2, the electrolyte analysis apparatus according to claim 1, the limitation “wherein the reagent generation unit generates the reagent by mixing the reagent stock solution and the pure water in a volume ratio such that the absolute value of the temperature difference between the reagent obtained by the dilution and restoration, and the pure water is smaller than the absolute value of the temperature difference between the reagent obtained by the dilution and restoration, and the reagent stock solution” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Kishioka teaches the above reagent generation unit as outlined in the rejection above that is specifically configured to perform the functional limitations above (Kishioka teaches an internal standard liquid preparation unit 440 which at least includes an internal standard liquid preparation container A441, an internal standard liquid preparation container B442, a drug substance supply unit 448 that supplies a drug substance 447 where the drug substance in a form of concentrated liquid may be used [the drug substance is in a form of concentrated liquid and corresponds to a reagent stock solution], an internal standard liquid syringe 131, electromagnetic valve 123, stirring mechanisms 443 and 444, and switching valves [electromagnetic valves 421, 422 and 423] [these structures corresponding to a reagent generation unit]. Kishioka further teaches a pure water supply pump 481 that introduces pure water into each preparation container where stirring mechanisms 443 and 444 stir and mix the drug substance 447 [the drug substance is in a form of concentrated liquid and corresponds to a reagent stock solution] and the pure water, thus diluting and restoring a reagent stock solution having a concentration higher than a predetermined ion concentration with pure water to generate a reagent/internal standard liquid having the predetermined ion concentration/set concentration range [Paras. 0096-0097, 0101-0102, 0147, 0124-0133 and Figs. 4-5, see rejection above]). Since the prior art does disclose a reagent generation unit comprising substantially the same elements or components as that of the applicant, it is contended that the reagent generation unit of the prior art is capable of performing the functional limitations above. Accordingly, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent and cannot have mutually exclusive properties, and thus, the claimed property or function (i.e., wherein the reagent generation unit generates the reagent by mixing the reagent stock solution and the pure water in a volume ratio such that the absolute value of the temperature difference between the reagent obtained by the dilution and restoration, and the pure water is smaller than the absolute value of the temperature difference between the reagent obtained by the dilution and restoration, and the reagent stock solution), is necessarily present in the prior art material [See MPEP 2112.01 (I)]).
Regarding claim 4, the electrolyte analysis apparatus according to claim 1, further comprising: a specimen dilution unit for diluting a specimen to be analyzed with pure water to generate a diluted specimen (Kishioka teaches a specimen “to be analyzed” dispensed into a dilution cup 120 by the dispensing nozzle, where the diluent in the diluent preparation container A451 is dispensed into the dilution cup 120 by using the diluent syringe pump 132 and the specimen “to be analyzed” is diluted in the set ratio D, thereafter the diluted specimen in the dilution cup 120 is sucked from the sipper nozzle 107 and introduced into the flow paths 1011, 1021 and 1031 of the ion selective electrodes 101, 102 and 103 [Para. 0126-0127]. Kishioka further teaches a diluent preparation unit 450 which prepares the diluent by introducing pure water from the pure water supply 481 into each preparation container as the pure water supply 481 is connected to the diluent preparation unit 450 and the liquid preparation containers 451 and 452 and the diluent preparation unit 450 similarly supplies the diluted drug substance 457 which is diluted by the pure water supply pump 481 that introduces pure water into each preparation container [0096-0098], the structures of the dispensing nozzle, dilution cup 120, diluent syringe pump 132, and the diluent preparation unit 450 corresponding to a specimen dilution unit for diluting a specimen to be analyzed with pure water [the pure water is contained in the diluent which dilutes the specimen, thus the specimen to be analyzed is diluted with pure water to generate the diluted specimen] to generate a diluted specimen [Para. 0126-0127, 0096-0098 and Figs. 4-5]), wherein
The limitation “the specimen dilution unit generates the diluted specimen such that the absolute value of the temperature difference between the diluted specimen and the pure water is smaller than the absolute value of the temperature difference between the specimen and the diluted specimen” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation 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. See MPEP 2114. In the instant case, Kishioka teaches the above specimen dilution unit as outlined in the rejection above that is specifically configured to perform the functional limitations above (Kishioka teaches a specimen “to be analyzed” dispensed into a dilution cup 120 by the dispensing nozzle, where the diluent in the diluent preparation container A451 is dispensed into the dilution cup 120 by using the diluent syringe pump 132 and the specimen “to be analyzed” is diluted in the set ratio D, thereafter the diluted specimen in the dilution cup 120 is sucked from the sipper nozzle 107 and introduced into the flow paths 1011, 1021 and 1031 of the ion selective electrodes 101, 102 and 103 [Para. 0126-0127]. Kishioka further teaches a diluent preparation unit 450 which prepares the diluent by introducing pure water from the pure water supply 481 into each preparation container as the pure water supply 481 is connected to the diluent preparation unit 450 and the liquid preparation containers 451 and 452 and the diluent preparation unit 450 similarly supplies the diluted drug substance 457 which is diluted by the pure water supply pump 481 that introduces pure water into each preparation container [0096-0098], the structures of the dispensing nozzle, dilution cup 120, diluent syringe pump 132, and the diluent preparation unit 450 corresponding to a specimen dilution unit for diluting a specimen to be analyzed with pure water [the pure water is contained in the diluent which dilutes the specimen, thus the specimen to be analyzed is diluted with pure water to generate the diluted specimen] to generate a diluted specimen [Para. 0126-0127, 0096-0098 and Figs. 4-5]. Since the prior art does disclose a specimen dilution unit comprising substantially the same elements or components as that of the applicant, it is contended that the specimen dilution unit of the prior art is capable of performing the functional limitations above. Accordingly, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent and cannot have mutually exclusive properties, and thus, the claimed property or function (i.e., the specimen dilution unit generates the diluted specimen such that the absolute value of the temperature difference between the diluted specimen and the pure water is smaller than the absolute value of the temperature difference between the specimen and the diluted specimen), is necessarily present in the prior art material [See MPEP 2112.01 (I)]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schmidt et al. (US20100247379A1) teaches a reagent preparing apparatus capable of being connected to a sample measuring section for measuring a sample using a diluted reagent prepared by the reagent preparing apparatus, comprising: a reagent preparing section for preparing a diluted reagent containing a predetermined reagent and pure water [see e.g., Abstract and Fig. 2].
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/S.Y.O./Examiner, Art Unit 1794
/JAMES LIN/Supervisory Patent Examiner, Art Unit 1794
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