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
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/639,768, filed on 02/18/2020.
Status of Claims
Applicant's arguments, filed 02/05/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 02/05/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicants have amended claims 1-4, 6, 11, 16-17, and 19.
Applicants have left claims 5, 7-10, 12-15, and 18 as originally filed/previously presented.
Claims 1-19 are the current claims hereby under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/29/2026 is being considered by the examiner.
Specification - Withdrawn
Response to Arguments
Applicant’s arguments, see page 11 of Remarks, filed 02/05/2026, with respect to the specification have been fully considered and are persuasive. Applicants have amended the specification, rendering the objection moot. The objection of the specification has been withdrawn.
Claim Objections
Response to Arguments
Applicant’s arguments, see page 11 of Remarks, filed 02/05/2026, with respect to claims 1, 3, 6, 16, and 17 have been fully considered and are persuasive. Applicants have amended the claims, rendering the objections moot. The objections of claims 1, 3, 6, 16, and 17 has been withdrawn.
Claim Interpretation - 35 USC § 112(f) - Maintained
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:
Claim 5: The claim limitation “an output port for providing an output to a user, a medical practitioner or a medical team …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “port” coupled with functional language “for providing an output to a user, a medical practitioner or a medical team …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “port”.
Claim 9: The claim limitation “an input port configured for receiving information …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “port” coupled with functional language “configured for receiving information …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “port”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“output means, e.g. output port, which may for example be implemented in the external device, e.g. in a dedicated device or in a dedicated computer program application … an auditive or display system”, or equivalents thereof, as described in para. [0171-0173] of the disclosure filed on 05/08/2023;
“input port of the health monitoring system may be configured for receiving the information regarding one or more physiological parameters from a wearable, worn by the user … receiving information regarding the user via user input, via apps used by the user”, or equivalents thereof, as described in paras. [0177], [0180], and [0183] of the disclosure filed on 05/08/2023.
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 - Withdrawn
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.
Response to Arguments
Applicant’s arguments, see pages 11-12 of Remarks, filed 02/05/2026, with respect to claims 3-4, 6, 11, and 17 have been fully considered and are persuasive. Applicants have amended the claims, rendering the rejections moot. The 112(b) rejection of claims 3-4, 6, 11, and 17 has been withdrawn.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Response to Arguments
Applicant’s arguments, see page 12 of Remarks, filed 02/05/2026, with respect to claim 19 have been fully considered and are persuasive. Applicants have amended the claim, rendering the rejection moot. The 112(d) rejection of claim 19 has been withdrawn.
Claim Rejections - 35 USC § 101 - Maintained/Modified Necessitated by Applicant’s Amendments and Withdrawn
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Analysis of independent claims 1 and 16:
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claim 1 is directed to a system, which describes one of the four statutory categories of patentable subject matter, i.e., a machine. Claim 16 is directed to a method, which describes one of the four statutory categories of patentable subject matter, i.e., a process. Therefore, further consideration is necessary.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claim 1 and claim 16 recite an abstract idea. In particular, the claims recite the following:
Determining, from the stored creatinine information and the stored glucose related information, a kidney-related parameter for the living creature.
These elements recited in claims 1 and 16 are drawn to an abstract idea since (1) they involve a mental process that can be practically performed in the human mind including observation, evaluation, judgment, and opinion and using pen and paper.
Determining, from the stored creatinine information and the stored glucose related information, a kidney-related parameter for the living creature is directed towards a mental process that can be practically performed in the human mind. For example, a person with ordinary skill in the art could reasonably determine a kidney-related parameter from creatinine information and glucose related information, with the aid of pen and paper and/or a look up table. For example, a person could reasonably determine a kidney-related parameter based on an increase or decrease in creatinine levels and glucose levels. There is nothing to suggest an undue level of complexity in determining a kidney-related parameter.
Prong Two: Claims 1 and 16 do not recite additional elements that integrate the exception into a practical application. Therefore, the claims are “directed to” the abstract idea. The additional elements merely:
Recite the words “apply it” or an equivalent with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g., “a processor”), and
Add insignificant extra-solution activity (the pre-solution activity of: using generic data-gathering components (e.g. “an implantable sensor configured for repetitively measuring simultaneously creatinine information and glucose related information in bodily tissue or bodily fluids of the living creature …”).
As a whole, the additional elements merely serve to gather information to be used by the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. The processing performed remains in the abstract realm, i.e., the result is not used for a treatment. No improvement to the technology is evident. Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional. For example, “an implantable sensor configured for repetitively measuring simultaneously creatinine information and glucose related information” is well-understood, routine, and conventional, as disclosed by Rebec et al. (US 20130303865 A1) - para. [0031], [0037], [0040].
Further, “a processor” does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1 and 16 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above. E.g., all elements are directed to pre-solution elements directed towards necessary data gathering, which merely facilitate the abstract idea.
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Analysis of the dependent claims:
Claims 2-15 and 17-19 depend from the independent claims. The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
Further describe the abstract idea (“determining the kidney-related parameter from the combination of the stored creatinine information and glucose related information” (claim 3), “comparing the creatinine information with a predetermined range, wherein the predetermined range is based on previously measured creatinine information from the living creature” (claim 7), “determining an estimated glomerular filtration rate (eGFR)” (claim 8), “detection of a worsening renal function and/or for prognosis of the renal function of the living creature” (claim 11), “using the creatinine information in combination with the one or more of lipids, urea or albumin for monitoring chronic kidney disease progression” (claim 12), “time-dependent monitoring during a dialysis session and wherein the processor is configured for indicating a blood condition as function of the dialysis that is performed in the dialysis session” (claim 14), “said determining the kidney-related parameter being determining from the combination of the stored creatinine information and glucose related information” (claim 17), “time-dependent monitoring during a dialysis session and indicating a blood condition as function of the dialysis that is performed in the dialysis session” (claim 19)),
Further describe the pre-solution activity (or the structure used for such activity) (“the kidney-related condition correspond to one of an artificial kidney, a transplanted kidney or an own kidney of the living creature” (claim 2), “the implantable sensor is configured for obtaining spectrophotometric sensing data and for deriving the creatinine information and the glucose related information from the same spectrophotometric sensing data” (claim 4), “the creatinine information is a creatinine concentration” (claim 6), “an input port configured for receiving information regarding at least one of an age, length, weight, gender and/or ethnical characteristic of the human being and the processor being configured for taking into account one, more or all of said at least one of age, length, weight, gender and/or ethnical characteristic of the human being for determining the estimated glomerular filtration rate” (claim 9), “detecting one or more of lipids, urea or albumin” (claim 12)), and
Further describe the post-solution activity (“an output port for providing an output to a user, a medical practitioner or a medical team and wherein the monitoring system is programmed for providing personalised recommendations regarding the kidney-related parameter to the user through the output port” (claim 5), “indicating whether the obtained creatinine concentration is within a predetermined range, for providing a user of the monitoring system with a warning for consulting a medical practitioner, or for providing a warning to a medical practitioner of the user the monitoring system” (claim 6), “indicating a degree or stage of diabetes nephropaty or Lupus Nephritis and/or for indicating that a consult with a medical practitioner is advised” (claim 10), “indicating, after a kidney transplant in a patient, a degree of acceptance of a transplanted kidney by the body of the patient and/or monitoring a graft stability” (claim 13), “outputting an indication that, once a blood condition is determined to be appropriate, the dialysis session may be stopped” (claim 15), “indicating, after a kidney transplant in a patient, a degree of acceptance of a transplanted kidney by the body of the patient and/or monitoring a graft stability” (claim 18)) (recited at a high level of generality).
Per the Berkheimer requirement, the additional elements are well-understood, routine, and conventional.
For example, an implantable sensor for obtaining spectrophotometric sensing data for deriving creatinine information and glucose information is well-understood, routine, and conventional, as disclosed by Joseph et al. (US 20160022180 A1) - para. [0132], para. [0134], para. [0166], para. [0209].
For example, an output port is well-understood, routine, and conventional, as disclosed by Rebec et al. (US 20130303865 A1) - para. [0100-0101], para. [0120].
For example, an input port is well-understood, routine, and conventional, as disclosed by Rebec et al. (US 20130303865 A1) - para. [0138-0139].
Taken alone or in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way. The additional elements do not add anything significantly more than the abstract idea. The collective functions of the additional elements merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements improves the functioning of a computer, output device, improves technology other than the technical field of the claimed invention, etc. Therefore, the claims are rejected as being directed to non-statutory subjection matter. Claims 1-19 are rejected.
Response to Arguments
Applicant's arguments filed 02/05/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 12-14 of Remarks, filed 02/05/2026, that “The claim is accordingly directed to a technological system for in-vivo physiological monitoring, not to a natural correlation or abstract idea itself … Claim 1 requires implantation of a sensor within a living creature, simultaneously biochemical measurement in bodily tissue or fluids, and programmed data processing by a processor. These steps cannot be performed in the human mind … the claim … recites significantly more than the alleged exception …”.
The Examiner respectfully disagrees. As recited above, an implantable sensor configured for repetitively measuring simultaneously creatinine information and glucose related information has been shown to be well-understood, routine, and conventional, and is a pre-solution step of necessary data gathering to be used by the abstract idea as outlined above. Further, “an implantable sensor” is recited at a very high level of generality. As recited above, a processor for implementing an abstract idea does not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)). Therefore, the additional elements of the implantable sensor and the processor do not integrate the abstract idea into a practical application.
Applicants have argued on page 14 of Remarks, filed 02/05/2026, that “the claimed system improves medical monitoring technology by enabling continuous, in-vivo kidney monitoring, reduced reliance on intermittent laboratory testing, and improved temporal resolution of physiological changes”.
The Examiner respectfully disagrees. Applicants arguments are not commensurate in scope with the claimed invention. Specifics of the implantable sensor and determining of a kidney-related parameter are not claimed. Further, having the claims focus on determining the health state of the human body is not itself limiting the claims to improving the technology because cases that involve practical, technological improvements extend beyond simply improving the accuracy of a prediction.1 See, e.g., McRO, Inc. v. Bandai Namco Games America Inc., 837 F.3d 1299, 1315 (Fed. Cir. 2016) (“The claimed process uses a combined order of specific rules that renders information into a specific format that is then used and applied to create desired results: a sequence of synchronized, animated characters.”); Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1304 (Fed. Cir. 2018) (finding patent eligible a claim drawn to a behavior-based virus scan that protects against viruses that have been “cosmetically modified to avoid detection by code-matching virus scans”); Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1330, 1333 (Fed. Cir. 2016) (discussing patent eligible claims directed to “an innovative logical model for a computer database” that included a self-referential table allowing for greater flexibility in configuring databases, faster searching, and more effective storage); CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358, 1368 (Fed. Cir. 2020) (explaining that the claims at issue focus on a specific means for improving cardiac monitoring technology; they are not “directed to a result or effect that itself is the abstract idea and merely invoke generic processes and machinery” (quoting McRO, 837 F.3d at 1314)).
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Response to Arguments
Applicant’s arguments, see page 14 of Remarks, filed 02/05/2026, with respect to claim 2 have been fully considered and are persuasive. Applicants have amended the claim to no longer be directed to or encompass a human organism, rendering the rejection moot. The 101 rejection regarding a human organism of claim 2 has been withdrawn.
Claim Rejections - 35 USC § 102 - Maintained/Modified Necessitated by Applicant’s Amendments
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 1-3 and 5-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rebec et al. (US 20130303865 A1) (previously cited), hereinafter referred to as Rebec.
The claims are generally directed towards a monitoring system for monitoring a kidney-related condition of a living creature, the monitoring system comprising an implantable sensor configured for repetitively measuring simultaneously creatinine information and glucose related information in bodily tissue or bodily fluids of the living creature and for storing said creatinine information and said glucose related information, a processor programmed for determining, from the stored creatinine information and the stored glucose related information, a kidney-related parameter for the living creature.
Regarding claim 1, Rebec discloses a monitoring system for monitoring a kidney-related condition of a living creature (Abstract, “end stage renal disease monitoring system …”, Fig. 4A), the monitoring system comprising
an implantable sensor (Fig. 4A, Fig. 4E, element 400, para. [0085], “implantable sensor”) configured for repetitively measuring simultaneously creatinine information and glucose related information in bodily tissue or bodily fluids of the living creature and for storing said creatinine information and said glucose related information (para. [0034], para. [0037], “ESRD analyte sensor … detect glucose and one or more analytes that are relevant to kidney function …”, para. [0040], “analysis region … detect glucose concentrations … third analysis region … detect creatinine”, para. [0090-0092], “image capture device … processor, an optical sensor, a memory … image capture device may be configured to perform a rudimentary image analysis …”, para. [0095], para. [0098], para. [0100], para. [0134]),
a processor programmed for determining, from the stored creatinine information and the stored glucose related information, a kidney-related parameter for the living creature (para. [0027], “glucose, creatinine … used to monitor the status and progression of ESRD …”, para. [0034], para. [0090-0091], para. [0097], para. [0140-0143], “determining an estimated glomerular filtration rate based on the creatinine value …”, para. [0129]).
Regarding claim 2, Rebec discloses the monitoring system according to claim 1, wherein the kidney-related condition correspond to one of an artificial kidney, a transplanted kidney or an own kidney of the living creature (para. [0037], “relevant to kidney function …”, para. [0142], “early stage of kidney disease …”, para. [0156], “used to monitor kidney function in a user after a kidney transplant …”).
Alternatively and/or additionally, in regard to the limitation of “the kidney-related condition correspond to one of an artificial kidney, a transplanted kidney or an own kidney of the living creature”, it is considered an intended use of the claimed device. Such a limitation does not further limit the structure of the claimed device. There is no recitation in the claim what structural limitation causes the device to be compatible with a kidney that is an artificial kidney, a transplanted kidney or an own kidney of the living creature. As Rebec teaches monitoring kidney function and using the device with a transplanted kidney (para. [0037], para. [0142], para. [0156]), it is considered reading on the limitation of “the kidney-related condition correspond to one of an artificial kidney, a transplanted kidney or an own kidney of the living creature”. For the above consideration, see MPEP § 2114.II: "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
Regarding claim 3, Rebec discloses the monitoring system according to claim 1, wherein the processor is programmed for determining the kidney-related parameter from the combination of the stored creatinine information and glucose related information (para. [0027], “glucose, creatinine … used to monitor the status and progression of ESRD …”, para. [0034], para. [0129]).
Regarding claim 5, Rebec discloses the monitoring system according to claim 1, wherein the monitoring system furthermore comprises an output port for providing an output to a user, a medical practitioner or a medical team (para. [0100-0101], “displayed or communicated to the user … second computing system/database may be operated by a caretaker or a second medical provider …”, para. [0120]) and wherein the monitoring system is programmed for providing personalised recommendations regarding the kidney-related parameter to the user through the output port (para. [0100], “communicate the results to the user or to another device/system, and/or generate and communicate a message, notification, alert, instructions …”, para. [0120]).
Regarding claim 6, Rebec discloses the monitoring system according to claim 1, wherein the creatinine information is a creatinine concentration and wherein the processor is configured for indicating whether the obtained creatinine concentration is within a predetermined range, for providing a user of the monitoring system with a warning for consulting a medical practitioner, or for providing a warning to a medical practitioner of the user of the monitoring system (para. [0027], “creatinine … concentration”, para. [0032], para. [0120], “determined values exceeds an applied threshold value … sending an alert (e.g., to a user, a caretaker, a medical provider, etc.) …”).
Regarding claim 7, Rebec discloses the monitoring system according to claim 1, wherein the processor is configured for comparing the creatinine information with a predetermined range, wherein the predetermined range is based on previously measured creatinine information from the living creature (para. [0032], para. [0095], “previously determined representative values … creatinine reference ranges”, para. [0100], para. [0120], “determined values exceeds an applied threshold value …”, para. [0144], “determines that an eGFR value is lower than a previous eGFR value …”).
Regarding claim 8, Rebec discloses the monitoring system according to claim 1, the processor being adapted for determining an estimated glomerular filtration rate (eGFR) (para. [0139-0144], “select … a formula for calculating eGFR …”).
Regarding claim 9, Rebec discloses the monitoring system according to claim 8, the living creature being a human being (para. [0028], “human”) and the system comprising an input port configured for receiving information regarding at least one of an age, length, weight, gender and/or ethnical characteristic of the human being and the processor being configured for taking into account one, more or all of said at least one of age, length, weight, gender and/or ethnical characteristic of the human being for determining the estimated glomerular filtration rate (para. [0138-0139], “user’s age/birthdate, gender, ethnicity, weight, height, medications, or other information which may be input by the user … reader device may determine an estimated glomerular filtration rate based on the creatinine value, the user’s age, the user’s gender, and the user’s ethnicity …”).
Regarding claim 10, Rebec discloses the monitoring system according to claim 1, wherein the monitoring system is adapted for indicating a degree or stage of diabetes nephropaty or Lupus Nephritis and/or for indicating that a consult with a medical practitioner is advised (para. [0004], para. [0037], para. [0144], “send an instruction to the user to make an appointment with a medical care provider”).
Regarding claim 11, Rebec discloses the monitoring system according to claim 10, wherein the monitoring system is adapted for detection of a worsening renal function and/or for prognosis of the renal function of the living creature (para. [0036], “closer monitoring of ESRD …”).
Regarding claim 12, Rebec discloses the monitoring system according to claim 1, wherein the implantable sensor is furthermore configured for detecting one or more of lipids, urea or albumin (para. [0031], para. [0040], “detect blood urea nitrogen (BUN) …”, para. [0080]) and wherein the processor is programmed for using the creatinine information in combination with the one or more of lipids, urea or albumin for monitoring chronic kidney disease progression (para. [0031], para. [0037], “ESRD sensors may be provided with multiple analysis regions … detect glucose and one or more analytes that are relevant to kidney function (e.g., BUN, creatinine …”).
Regarding claim 13, Rebec discloses the monitoring system according to claim 1, wherein the monitoring system is adapted for indicating, after a kidney transplant in a patient, a degree of acceptance of a transplanted kidney by the body of the patient and/or monitoring a graft stability (para. [0156], “monitor kidney function in a user after a kidney transplant …”).
Regarding claim 14, Rebec discloses the monitoring system according to claim 1, wherein the system is configured for time-dependent monitoring during a dialysis session and wherein the processor is configured for indicating a blood condition as function of the dialysis that is performed in the dialysis session (para. [0136], “communicate calculated values and/or instructions to a medical device … may be a dialysis machine … one or more instructions to the dialysis machine to stop, start, continue operating, or alter the rate of fluid flow …”, para. [0149], para. [0152]).
Regarding claim 15, Rebec discloses the monitoring system according to claim 14, wherein the processor is configured for outputting an indication that, once a blood condition is determined to be appropriate, the dialysis session may be stopped (para. [0136], “communicate calculated values and/or instructions to a medical device … may be a dialysis machine … one or more instructions to the dialysis machine to stop, start, continue operating, or alter the rate of fluid flow …”, para. [0149], para. [0152], “computing system may determine that the dialysis should be ended …”).
Regarding claim 16, Rebec discloses a method of monitoring a kidney-related condition of a living creature (Abstract, “end stage renal disease monitoring system …”, para. [0028], “methods … for monitoring ESRD”, Fig. 4A), the method comprising
repetitively simultaneously measuring creatinine information and glucose related information in bodily tissue or bodily fluids of the living creature and storing said creatinine information and said glucose related information (para. [0034], para. [0037], “ESRD analyte sensor … detect glucose and one or more analytes that are relevant to kidney function …”, para. [0040], “analysis region … detect glucose concentrations … third analysis region … detect creatinine”, para. [0090-0092], “image capture device … processor, an optical sensor, a memory … image capture device may be configured to perform a rudimentary image analysis …”, para. [0095], para. [0098], para. [0100], para. [0134]), and
determining, from the stored creatinine information and the stored glucose related information, a kidney-related parameter for the living creature (para. [0027], “glucose, creatinine … used to monitor the status and progression of ESRD …”, para. [0034], para. [0090-0091], para. [0097], para. [0140-0143], “determining an estimated glomerular filtration rate based on the creatinine value …”, para. [0129]).
Regarding claim 17, Rebec discloses the method according to claim 16, said determining the kidney-related parameter being determining from the combination of the stored creatinine information and glucose related information (para. [0027], “glucose, creatinine … used to monitor the status and progression of ESRD …”, para. [0034], para. [0129]).
Regarding claim 18, Rebec discloses the method according to claim 16, the method comprising indicating, after a kidney transplant in a patient, a degree of acceptance of a transplanted kidney by the body of the patient and/or monitoring a graft stability (para. [0156], “monitor kidney function in a user after a kidney transplant …”).
Regarding claim 19, Rebec discloses the method according to claim 16, the method comprising time-dependent monitoring during a dialysis session and indicating a blood condition as function of the dialysis that is performed in the dialysis session (para. [0136], “communicate calculated values and/or instructions to a medical device … may be a dialysis machine … one or more instructions to the dialysis machine to stop, start, continue operating, or alter the rate of fluid flow …”, para. [0149], para. [0152], “computing system may determine that the dialysis should be ended …”).
Response to Arguments
Applicant's arguments filed 02/05/2026 have been fully considered but they are not persuasive.
Applicants have argued on page 15 of Remarks, filed 02/05/2026, that “Rebec does not disclose or unambiguously teach simultaneous measurement of creatinine and glucose as a function of the system, nor a sensor configuration necessarily configured to perform such simultaneous measurements in operation”.
The Examiner respectfully disagrees. As reiterated above, Rebec teaches simultaneous measurement of creatine and glucose through the use of multiple analysis regions and using an image capture device with an optical sensor to perform image analysis on the multiple analysis regions para. [0034], para. [0037], “ESRD analyte sensor … detect glucose and one or more analytes that are relevant to kidney function …”, para. [0040], “analysis region … detect glucose concentrations … third analysis region … detect creatinine”, para. [0090-0092], “image capture device … processor, an optical sensor, a memory … image capture device may be configured to perform a rudimentary image analysis …”, para. [0095], para. [0098], para. [0100], para. [0134]).
Applicants have argued on page 15-16 of Remarks, filed 02/05/2026, that “There is accordingly no teaching or suggestion in Rebec of a processor programmed to determine a kidney-related parameter from creatinine and glucose information …”.
The Examiner respectfully disagrees. As reiterated above, Rebec discloses determining a kidney-related parameter from both glucose information and creatinine information (para. [0027], “glucose, creatinine … used to monitor the status and progression of ESRD …”, para. [0034], para. [0090-0091], para. [0097], para. [0140-0143], “determining an estimated glomerular filtration rate based on the creatinine value …”, para. [0129], “representative value may include comparing … glucose range or a creatinine range …”). The claims currently do not recite how the creatinine information and the glucose related information is used to determine a kidney-related parameter, and the claims do not recite what a kidney-related parameter is.
Claim Rejections - 35 USC § 103 - Maintained/Modified Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Rebec et al. (US 20130303865 A1) (previously cited), hereinafter referred to as Rebec, in view of Joseph et al. (US 20160022180 A1) (previously cited), hereinafter referred to as Joseph.
Regarding claim 4, Rebec discloses the monitoring system according to claim 1.
However, Rebec does not explicitly disclose wherein the implantable sensor is configured for obtaining spectrophotometric sensing data and for deriving the creatinine information and the glucose related information from the same spectrophotometric sensing data.
Joseph teaches of an analogous long-term implantable monitoring system (Abstract, Fig. 1, para. [0019]). Joseph teaches the system includes an implanted sensor for repetitively measuring creatinine information in bodily tissue or bodily fluids, storing said creatinine information (Fig. 1, element 105, para. [0082], para. [0132-0134], para. [0228]). Joseph teaches the system is configured for substantially simultaneously measuring glucose related information in said bodily tissue or bodily fluids and for storing said glucose related information (para. [0082], para. [0132-0134], para. [0209], para. [0228]). Joseph further teaches the implantable sensor is configured for obtaining spectrophotometric sensing data and for deriving the creatinine information and the glucose related information from the same spectrophotometric sensing data (para. [0082], para. [0132-0134], “sensor can be a flow-through sensor that monitors the chemical concentration and/or physical composition of the solution (i.e., glucose … creatinine …) optical sensor can use near-infrared spectroscopy …”, para. [0209]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implantable sensor disclosed by Rebec to be configured for obtaining spectrophotometric sensing data and for deriving the creatinine information and the glucose related information from the same spectrophotometric sensing data, as taught by Joseph. This is because Joseph teaches optical sensing methods are advantageous as they do not produce byproducts that are toxic or harmful to the body or the implant (para. [0135]). Additionally, one of ordinary skill in the art would recognize spectrophotometric sensing is a simple and suitable substitution for the optical chemical sensor disclosed by Rebec.
Response to Arguments
Applicants arguments filed 02/05/2026 did not directly address this rejection. The Examiner cannot find a reason to withdraw it.
Conclusion
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.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
1 See In re Board of Trustees of Leland Stanford Junior University, 991 F.3d 1245 (Fed. Cir. 2021).