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 .
Response to Amendment
Examiner acknowledges the amendment filed 25 March 2026 wherein: claims 1-14 are amended; claims 1-14 are pending.
Response to Arguments
Applicant’s arguments, see Remarks (page 8, first line through page 12, last line), filed 25 March 2026, have been fully considered. Examiner acknowledges the prior claim objections the prior claim objections have been overcome. Examiner further acknowledges that limitations which previously invoked 35 U.S.C. § 112(f) have been amended. However, the new limitations still use generic placeholders coupled with functional language without reciting sufficient structures to perform the recited functions, and the generic placeholders are not preceded by structural modifiers. Accordingly, the amended limitations still invoke 35 U.S.C. § 112(f) and still require rejection under 35 U.S.C. § 112(b) due to a lack of description of the corresponding structures in Applicant’s specification. Examiner further acknowledges some 35 U.S.C. § 112(b) rejections have been overcome by amendment; however, some remain or are newly required due to amendment as described below.
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 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) 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):
(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). The presumption that the claim limitation is interpreted under 35 U.S.C. § 112(f) 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). The presumption that the claim limitation is not interpreted under 35 U.S.C. § 112(f) 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), 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) 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) 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. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. § 112(f), 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), Applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. § 112(f) (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).
Claims 1, 3, and 14
Claims 1, 3, and 14 are interpreted under 35 U.S.C. § 112(f).
Claim 1
Regarding claim 1, the limitation “computational device” uses the generic placeholder “device” 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. Accordingly, this limitation is interpreted under 35 U.S.C. § 112(f) as corresponding to any means capable of performing the claimed function because no corresponding structure is described in Applicant’s specification.
Similarly, the limitation “data communication and data representing module” (with generic placeholder “module”) is interpreted under 35 U.S.C. § 112(f) as corresponding to any means capable of performing the claimed function because no corresponding structure is described in Applicant’s specification.
Claims 3 and 14
The limitations “signal processing module”, “data acquisition module”, and “computational device” are interpreted under 35 U.S.C. § 112(f) as corresponding to any means capable of performing the claimed function because no corresponding structure is described in Applicant’s specification.
Claim Rejections — 35 U.S.C. § 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.
Claims 1-14
Claims 1-14 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 3, and 14
Regarding claims 1, 3, and 14, for each claim:
One or more claim limitations invoke 35 U.S.C. § 112(f). 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 described above. Therefore, the claim is indefinite and is rejected under 35 U.S.C. § 112(b).
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);
(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 3 and 14
Regarding claim 3, the limitation “the computational device” lacks sufficient antecedent basis. The limitation “the device” is indefinite because multiple devices are previously recited.
Claims 4-13
Regarding claims 4-13, the limitation “the device” is indefinite because multiple devices are previously recited in claim 3.
Claim 11
Regarding claim 11, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c)(I). In the present instance, claim 1 recites the broad recitation “not more than 1 min”, and the claim also recites “not more than 1 s” which is the narrower statement of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim. A narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim.
Claims 2-14
Regarding claims 2-14, the claims are further rejected due to their dependence on indefinite claims.
Allowable Subject Matter
Claims 1-14
Claims 1-14 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. § 112(b) set forth in this Office action. The following is a statement of reasons for the indication of allowable subject matter:
Claim 1
Regarding claim 1, as best understood, the cited prior art does not expressly disclose or suggest the claimed invention, particularly the claimed use of the particularly claimed concentration equation, in combination with the other elements of the claim.
The cited prior art discloses some elements of the claim. Fridolin-2013 (US 2013/0193347 A1) discloses a multiparametric optical method for assessing concentration of uremic solutes (concentrations of protein-bound and middle-sized uremic solutes), including uremic toxins (5) in biological solutions (1) wherein the biological solution (1) is transferred into measurement cuvette (“fluorimetrical cuvette”), biological solution (1) is illuminated with optical signal in the cuvette, transmitted light from the biological solution (1) is registered with detector (“light detector”), and concentration of uremic solutes (concentrations of protein-bound and middle-sized uremic solutes) in the biological solution (1) is assessed with program executed in the computing device (3) characterized in that optical signal is registered at least at two wavelength ranges at absorbance and/or fluorescence spectral optimums of the uremic solutes; light absorbance and fluorescence are assessed from the light transmitted from the biological fluid at suitable wavelengths; and concentrations of protein-bound and middle-sized uremic solutes, and glycation end- products, including indoxyl sulphate, and beta-2-microglobulin are assessed, and calculated concentrations are transferred to a display device (4; ¶ 1, 43, 51-56; Fig. 1).
While various means for determining concentration of uremic solutes using fluorescence measurements were generally known in the art, the cited prior art does not expressly disclose or suggest Applicant’s particularly claimed use of the particularly claimed concentration equation. Accordingly, claim 1 would be allowable.
Claims 2-14
Regarding claims 2-14, as best understood, the claims would be allowable due to their dependence.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Meibaum (US 2013/0237896 A1) discloses determining the concentration of UV active uremic toxins in spent dialysate (¶¶ 33-34).
Alic (US 2015/0323447 A1) discloses determining the concentration of uremic toxins in a fluid excreted or extracted from a body (¶ 35).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAKE RIDDICK whose telephone number is (571)270-1865. The examiner can normally be reached M - Th 6:30 am - 5:00 pm ET, with flexible scheduling.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Uzma Alam can be reached at 571-272-2995. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Blake C. Riddick, Ph.D.
Primary Examiner
Art Unit 2884
/BLAKE C RIDDICK/ Primary Examiner, Art Unit 2884
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