DETAILED ACTION
1. The amendment of September 4, 2025 has been entered into the record.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
3. The amendment filed om is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: ‘the control unit 140 is a component of a computer’s central processing unit (CPU)’ (the underlined material is not supported by the original disclosure) of paragraph [0032]. Applicant’s disclosure only reiterates the term ‘control unit’ with the Figures referring to a functional block as a ‘control unit’ which appears to be at most a standalone dedicated unit that is not a component of a CPU (FIG. 1: 140; FIGS. 8 and 9: 230). Applicant’s disclosure describes the control unit as having functions of estimation (abstract, paragraphs [0007], [0059], [0060], [0062], [0065], [0075], [0085], and [0098]), calculation (paragraphs [0062], [0070], and [0075], determination/obtaining (paragraphs [0010], [0066], [0073], [0074], [0075], [0083], and [0086]), and signal reception (paragraph [0042], [0044], [0054], and [0098]).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Interpretation
4. 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.
5. 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.
6. 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: detection unit in claim 1 and control unit in claim 1.
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
7. 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.
8. Claims 1-3 and 5-6 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.
As for claim 1, claim limitation “control 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. With regards to ‘control unit’, the specification appears to only reiterates this term noting that the Figures refer to a functional block as the ‘control unit’ (FIG. 1: 140; FIGS. 8 and 9: 230). Therefore, it is unclear as to what structure performs control in the applicant’s disclosure. 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.
Claims 2, 3, 5, and 6 are rejected by virtue of their dependency.
9. 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.
10. Claims 1-3 and 5-6 are 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.
As for claim 1, claim limitation ‘control unit’ has been interpreted as invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The specification appears to only reiterate this term noting that the Figures refer to a functional block as the ‘control unit’ (FIG. 1: 140; FIGS. 8 and 9: 230). Therefore, it is unclear as to what structure corresponds to this term. The term is an indefinite, unbounded limitation thereby covering all ways of performing control and indicates that the inventor had not provided sufficient disclosure to show possession of the invention.
Lastly, regarding claim 1 and ‘configured to determine a dilution factor of suspended substances or turbidity substances in the fluid to be measured, by using a first diameter of the inner tube and a second diameter of the outer tube, and estimate a concentration of the suspended substances or turbidity substances on the basis of the dilution factor,’ there does not appear to be any description of what constitutes a dilution factor. There does not appear to be any description of how to perform or accomplish the determination of the dilution factor. There does not appear to be any description of how to perform or accomplish the concentration estimation ‘on the basis of the dilution factor.’
Claims 2, 3, 5, and 6 are rejected by virtue of their dependency.
Allowable Subject Matter
11. Claims 1-3 and 5-6 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and if the rejection under 35 USC 112(a) is overcome.
Response to Arguments
12. Applicant’s arguments, see Remarks (last four lines of page 6), filed September 4, 2025, with respect to FIG. 2 have been fully considered and are persuasive. Due to the filing of a replacement sheet on September 4, 2025, the previous drawing objection has been withdrawn.
Applicant's arguments filed September 4, 2025 with regards to the rejections under 35 USC 112(b) and USC 112(a) (see Remarks pages 7-8) have been fully considered but they are not persuasive.
Regarding the rejections under 35 USC 112(b) and the applicant submitting that the term ‘control unit’ refers to a component of a central processing unit that manages a computer’s operations (see Remarks: page 7 second paragraph) and that the amendment to paragraph [0032] to describe “The control unit 140 is a component of a computer’s central processing unit (CPU)” does not introduce new matter because the mere inclusion of dictionary or art recognized definitions known at the time of filing an application may not be considered new matter (see MPEP 2163.07, section I) and stating that the structure of the control unit is inherent in the specification see Remarks: page 7 third paragraph), the examiner disagrees. ‘Control unit’ does not necessarily just refer to a component of a CPU but to a standalone dedicated unit. As stated above with regards to the objection to the specification, Applicant’s disclosure only reiterates the term ‘control unit’ with the Figures referring to a functional block as a ‘control unit’ which appears to be at most a standalone dedicated unit that is not a component of a CPU (FIG. 1: 140; FIGS. 8 and 9: 230). Applicant’s disclosure describes the control unit as having functions of estimation (abstract, paragraphs [0007], [0059], [0060], [0062], [0065], [0075], [0085], and [0098]), calculation (paragraphs [0062], [0070], and [0075], determination/obtaining (paragraphs [0010], [0066], [0073], [0074], [0075], [0083], and [0086]), and signal reception (paragraph [0042], [0044], [0054], and [0098]).
The examiner also refers applicant to MPEP 2163.07 I:
If there are multiple definitions for a term and a definition is added to the application, it must be clear from the application as filed that applicant intended a particular definition, in order to avoid an issue of new matter and/or lack of written description. See, e.g., Schering Corp. v. Amgen, Inc., 222 F.3d 1347, 1352-53, 55 USPQ2d 1650, 1654 (Fed. Cir. 2000).
Regarding the rejections under 35 USC 112(a) and the applicant referring to the amendment to the specification (see Remarks: last paragraph of page 7) to describe “The control unit 140 is a component of a computer’s central processing unit (CPU)” thereby making it clear as to what structure corresponds to the term “control unit,” the examiner disagrees. As stated above, 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: ‘the control unit 140 is a component of a computer’s central processing unit (CPU)’ (the underlined material is not supported by the original disclosure) of paragraph [0032].
Regarding the rejections under 35 USC 112(a) (see Remarks: page 8) and the applicant referring to paragraphs [0083], [0084], FIGS. 4A and 4B, as providing adequate description of how to determine a dilution factor, the examiner disagrees. As the stated above in the rejection, ‘there does not appear to be any description of what constitutes a dilution factor. There does not appear to be any description of how to perform or accomplish the determination of the dilution factor.’ Paragraph [0083] only refers determining the dilution factor ‘by using the first diameter R1 of the inner tube 111 and a second diameter R2 of the outer tube.’ What constitutes the determined dilution factor when it is based on ‘using the first diameter’ and ‘a second diameter R2’? How are the diameters used to determine a dilution factor? And apparently the only use of a ratio of the diameters is to determine a resolution (last two lines of paragraph [0083]. As well paragraph [0084] is not clear with regards to the dilution factor being proportional to the ratio of the outer tube diameter and the inner tube diameter. Paragraph [0084] states that the ‘dilution factor may vary’ between the multi-tubular structures of FIGS. 4A and 4B if the outer diameters differ and the inner diameters are the same and that the dilution factor of the multi-tubular structure 110 in FIG. 4B ‘may be larger’ if its outer tube diameter is larger than the outer tube diameter of the multi-tubular structure 110 in FIG. 4A. ‘May be’ suggests that the dilution factor is not necessarily proportional to an outer tube diameter or a ratio of the outer tube diameter and the inner tube diameter which seems to make the relationship between dilution factor and the inner and outer diameters unclear.
Regarding the rejections under 35 USC 112(a) (see Remarks: page 8) and the applicant referring to paragraphs [0085] and [0086], as providing adequate description of how to estimate a concentration of the suspended substances or turbidity substances on the basis of the dilution factor, the examiner disagrees. Paragraph [0085] merely refers to using dilution when high-concentration fluids need to be measured, and paragraph [0086] refers to determining the dilution factor by using the first diameter of the inner tube and the second diameter of the outer tube in which ‘then may’ the concentration be estimated ‘using the dilution factor.’ Again, what constitutes the determined dilution factor when it is based on ‘using the first diameter’ and ‘a second diameter R2’? How are the diameters used to determine a dilution factor? How is the dilution factor used to estimate the concentration of the suspended substances or the turbidity substances?
The applicant notes that the ‘specification does not describe how to estimate a concentration based on the dilution factor in detail’(Remarks: page 8: last two lines of third paragraph). The examiner reminds the applicant of the following:
MPEP 2163 II 3(a) (see third paragraph): The description need only describe in detail that which is new or not conventional. See Hybritech v. Monoclonal Antibodies, 802 F.2d at 1384, 231 USPQ at 94.
Applicant’s arguments, see Remarks (last three lines of page 8 to line 9 of page 9), with respect to the previous rejections under 35 USC 103 have been fully considered and are persuasive. Due to the amendment to the claims, the previous rejections under 35 USC 103 have been withdrawn.
Conclusion
13. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: please refer to the attached PTO-892. The examiner also specifically notes the following:
US 2015/0330817 to Law et al. teaches a control unit comprising a central processing unit (Figure 2: 20 and 23; paragraph [0029]).
US 10,234,387 to Kambayashi et al. teaches a control unit realized as a central processing unit, a random access memory, or a dedicated hardware circuit (col. 3, line 62-col. 4, line 3).
US 10,663,399 to Kambayashi et al. teaches a control unit that can analyze concentration, turbidity, absorbance, and the like (col. 4, lines 30-45) and realized as a central processing unit, a random access memory, or a dedicated hardware circuit (col. 4, lines 46-49).
US 11,428,621 to Kambayashi et al. teaches a control unit realized as a central processing unit, a random access memory, or a dedicated hardware circuit (col. 4, lines 15-18).
14. 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.
Fax/Telephone Numbers
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Gordon J. Stock, Jr. whose telephone number is (571) 272-2431.
The examiner can normally be reached on Monday-Friday, 10:00 a.m. - 6:30 p.m.
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supervisor, Kara Geisel, can be reached at 571-272-2416. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GORDON J STOCK JR/
Primary Examiner, Art Unit 2877