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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/14/26 has been entered.
Notice of Amendment
In response to the amendment(s) filed on 1/14/26, amended claim(s) 1-2, 6-7, 13, and 18-21 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Objections
Claim 2 is objected to because of the following informalities: “the continuous analyte sensor transcutaneous continuous potassium sensor” (lines 1-2) appears that it should be “the transcutaneous continuous potassium sensor.”
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.
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: “a transcutaneous continuous potassium sensor configured to generate analyte measurements associated with potassium levels of a patient during a plurality of time periods, the analyte measurements indicating a potassium level present in the interstitial fluid of the patient,” in claim 1, which corresponds to “a body, a working electrode, a reference electrode, and/or a counter electrode” (see para [0517] of Applicant’s specification as originally filed).
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
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.
Claim(s) 1-2 and 5-22 is/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.
For claim 1, the claim term “the continuous analyte sensor” (line 5) lacks antecedent basis. The claim is examined as this referred back to the previously recited “continuous potassium sensor.”
For claim 10, the claim term “the kidney function” (line 3) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 10, the claim term “the kidney” (line 6) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 18, the claim term “the change in interstitial potassium levels” (lines 1-2) lacks antecedent basis. The claim is examined as this referring back to “a change in in-vivo potassium levels” recited in claim 1.
For claim 18, the claim term “the first period of time” (line 3) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 18, the claim term “the second period of time” (lines 4-5) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 18, the claim term “the real-time data stream of estimated interstitial potassium values” (line 8) lacks antecedent basis. The claim is examined as this referred back to “estimated potassium values representative of an in-vivo level of potassium” recited in claim 1.
Dependent claim(s) 2 and 5-22 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-2 and 5-22 is/are rejected under 35 U.S.C. 112(b).
Claim Rejections - 35 USC § 101
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.
Claim(s) 1-2 and 5-22 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “process the analyte measurements to determine a real-time data stream of estimated potassium values representative of an in-vivo level of potassium in the interstitial fluid or blood of the patient,” “determine, based on the real-time data stream of estimated potassium values, a change in in-vivo potassium levels for the patient from a first of the plurality of time periods to a second of the plurality of time periods,” and “determine, based on the change in in-vivo potassium levels, a disease prediction of the patient.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “a transcutaneous continuous potassium sensor configured to generate analyte measurements associated with potassium levels of a patient during a plurality of time periods, the analyte measurements indicating a potassium level present in the interstitial fluid of the patient,” “a sensor electronics module coupled to the continuous potassium sensor,” “a memory comprising executable instructions,” and “one or more processors in data communication with the sensor electronics module and configured by the executable instructions.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0293] of U.S. Patent Application Publication No. 2014/0158538 to Collier et al. and/or para [0098] of U.S. Patent Application Publication No. 2006/0217771 to Soykan et al. and Alice v. CLS, which held that generic computer structures do not otherwise transform a patent-ineligible claim into a patent-eligible one. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2 and 5-22 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas, further limitations on abstract ideas already recited, and/or additional elements that are not significantly more. For claim 2, the additional elements of “wherein the continuous analyte sensor comprises: a substrate, a working electrode disposed on the substrate, a reference electrode disposed on the substrate,” are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0006] of U.S. Patent Application Publication No. 2022/0400984 to Lee et al. (hereinafter “Lee”). For claim 15, the additional elements of “wherein the one or more other non-analyte sensors comprise at least one of an insulin pump, an accelerometer, a temperature sensor, an electrocardiogram (ECG) sensor, a heart rate monitor, a blood pressure sensor, an impedance, a peritoneal dialysis machine, a hemodialysis machine, a continuous positive airway pressure machine, a body sound sensor, or a respiratory sensor,” are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0030] of U.S. Patent Application Publication No. 2020/0359913 to Ghodrati et al. (hereinafter “Ghodrati”). Thus, claim(s) 1-2 and 5-22 is/are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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(s) 1, 5-7, 13-15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0316219 to Paz et al. (hereinafter “Paz”) in view of U.S. Patent Application Publication No. 2021/0045640 to Poltorak.
For claim 1, Paz discloses a monitoring system (Abstract), comprising:
a transcutaneous continuous potassium sensor configured to generate analyte measurements associated with potassium levels of a patient during a plurality of time periods, the analyte measurements indicating a potassium level present in the interstitial fluid of the patient (Examiner’s Note: construed in view of the 112(f) invocation above) (114) (Fig. 1) (para [0124]) (also see para [0118]); and
a sensor electronics module (150) (Fig. 1) (para [0112]) coupled to the continuous potassium sensor (as can be seen in Fig. 1);
a memory (146) (Fig. 1) (para [0117]) comprising executable instructions (para [0205]);
one or more processors (148) (Fig. 1) (para [0117]) in data communication with the sensor electronics module (as can be seen in Fig. 1) (also see para [0120]) and configured by the executable instructions (para [0129]) to:
process the analyte measurements (para [0128], [0194], and [0225]) to determine a real-time data stream of estimated potassium values (“continuously monitoring in real time at least … a potassium level,” para [0047]);
determine, based on the real-time data stream of estimated potassium values, a change in in-vivo potassium levels for the patient from a first of the plurality of time periods to a second of the plurality of time periods (para [0056], [0205], [0214], [0228], and [0236]); and
determine, based on the change in potassium levels, a disease prediction of the patient (para [0056], [0205], [0214], [0228], and [0236]).
Paz does not expressly disclose that the potassium values are a representative of an in-vivo level of potassium in the interstitial fluid or blood of the patient.
However, Poltorak teaches urinary potassium values that are representative of an in-vivo level of potassium in the interstitial fluid or blood of the patient (para [0060] and [0063]).
It would have been obvious to a skilled artisan to modify Paz such that the potassium values are a representative of an in-vivo level of potassium in the interstitial fluid or blood of the patient, in view of the teachings of Poltorak, for the obvious advantage of ensuring that the diagnosis of the patient is accurate (i.e., the urine potassium values represent potassium values that are actually in the patient), which is what Paz wants to do.
For claim 5, Paz further discloses wherein the analyte measurements of the patient are monitored continuously, semi-continuously, or periodically during the plurality of time periods (para [0118]).
For claim 6, Paz further discloses wherein the disease prediction comprises at least one of: an indication of a presence of kidney dysfunction in the patient (para [0039] [0047], [0056]-[0057], and/or [0073]); an indication of a severity of kidney dysfunction in the patient; an indication of a level of risk of the patient being diagnosed with kidney dysfunction; and an indication of a level of improvement or deterioration of the kidney dysfunction in the patient.
For claim 7, Paz further discloses wherein the indication of the level of improvement or the deterioration of kidney dysfunction in the patient is based, at least in part, on at least one of: a procedure previously performed on the patient; a drug previously ingested by the patient; one or more actions taken by the patient; or one or more other clinical actions (Examiner’s Note: this claim language being a further limitation on an alternative limitation previously recited in claim 6; because the alternative was not relied upon in the rejection of claim 6, Paz further satisfies this claim language since that another alternative is taught by Paz).
For claim 13, Paz further discloses wherein the processor is further configured to: monitor one or more other analytes (para [0039] [0047], [0056]-[0057], and/or [0073]), wherein the disease prediction is further generated using analyte data relating to the one or more other analytes (para [0039] [0047], [0056]-[0057], and/or [0073]), and wherein the one or more analytes include at least one of: glucose, creatinine, blood urea nitrogen (BUN), ammonia, C-peptide, and cystatin C (para [0039] [0047], [0056]-[0057], and/or [0073]).
For claim 14, Paz further discloses wherein the processor is further configured to: monitor other sensor data of the patient during the plurality of time periods using one or more other non-analyte sensors (para [0047], [0057], and [0073]), wherein the disease prediction is further generated using the other sensor data (para [0047], [0057], and [0073]).
For claim 15, Paz does not expressly disclose wherein the one or more other non-analyte sensors comprise at least one of an insulin pump, an accelerometer, a temperature sensor, an electrocardiogram (ECG) sensor, a heart rate monitor, a blood pressure sensor, an impedance, a peritoneal dialysis machine, a hemodialysis machine, a continuous positive airway pressure machine, a body sound sensor, or a respiratory sensor.
However, Paz does teach that heart rate, blood pressure, and central venous pressure are important parameters to be monitored for patients to maintain proper balance of fluid input and fluid output (para [0018]).
Therefore, it would have been obvious to a skilled artisan to modify Paz wherein the one or more other non-analyte sensors comprise at least one of an insulin pump, an accelerometer, a temperature sensor, an electrocardiogram (ECG) sensor, a heart rate monitor, a blood pressure sensor, an impedance, a peritoneal dialysis machine, a hemodialysis machine, a continuous positive airway pressure machine, a body sound sensor, or a respiratory sensor, in view of the teachings of Paz, to provide a means by sense these parameters to improve maintaining the proper balance of fluid input and output.
For claim 18, Paz further discloses wherein determining the change in in-vivo potassium levels comprises: establishing a baseline in-vivo potassium level for the patient during the first time period (para [0222]); and determining a change from the baseline in-vivo potassium level of the patient during the second period of time by comparing the in-vivo potassium level for the patient from the second period of time to the baseline in-vivo potassium level (para [0222]), based on the real-time data stream of estimated in-vivo potassium values (para [0222]).
Claim(s) 2 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak, and further in view of U.S. Patent Application Publication No. 2006/0293576 to Van Antwerp (hereinafter “Van Antwerp”).
For claim 2, Paz and Poltorak do not expressly disclose wherein the transcutaneous continuous potassium sensor comprises: a substrate, a working electrode disposed on the substrate, a reference electrode disposed on the substrate, wherein the analyte measurements generated by the transcutaneous continuous potassium sensor correspond to an electromotive force at least in part based on a potential difference generated between the working electrode and the reference electrode.
However, Van Antwerp teaches a substrate (para [0073]), a working electrode disposed on the substrate (para [0073]), a reference electrode disposed on the substrate (para [0073]), wherein the analyte measurements generated correspond to an electromotive force at least in part based on a potential difference generated between the working electrode and the reference electrode (para [0073]-[0074]) (also see para [0080]-[0081]).
It would have been obvious to a skilled artisan to modify Paz wherein the continuous analyte sensor comprises: a substrate, a working electrode disposed on the substrate, a reference electrode disposed on the substrate, wherein the analyte measurements generated by the transcutaneous continuous potassium sensor correspond to an electromotive force at least in part based on a potential difference generated between the working electrode and the reference electrode, in view of the teachings of Van Antwerp, because such a modification would be combining different known electrode structure(s) of analyte sensor(s) that would lead to the predictable result of monitoring a potassium concentration.
For claim 22, Paz further discloses wherein the potential difference corresponds to a concentration of potassium ions associated with the patient (para [0222]).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak, and further in view of U.S. Patent Application Publication No. 2020/0000824 to Moraitis.
For claim 8, Paz and Poltorak do not expressly disclose wherein the disease prediction comprises a least one of: an indication of a level of risk of the patient being diagnosed with at least one of hyperkalemia or hypokalemia within a first threshold amount of time; an indication of a level of risk of the patient experiencing a cardiac event within a second threshold amount of time; or an indication of a level of risk of the patient experiencing a severe medical consequence due to potassium imbalance of the patient within a third threshold amount of time.
However, Moraitis teaches wherein the disease prediction comprises a least one of: an indication of a level of risk of the patient being diagnosed with at least one of hyperkalemia or hypokalemia within a first threshold amount of time (para [0168]-[0174]); an indication of a level of risk of the patient experiencing a cardiac event within a second threshold amount of time; or an indication of a level of risk of the patient experiencing a severe medical consequence due to potassium imbalance of the patient within a third threshold amount of time.
It would have been obvious to a skilled artisan to modify Paz wherein the disease prediction comprises a least one of: an indication of a level of risk of the patient being diagnosed with at least one of hyperkalemia or hypokalemia within a first threshold amount of time; an indication of a level of risk of the patient experiencing a cardiac event within a second threshold amount of time; or an indication of a level of risk of the patient experiencing a severe medical consequence due to potassium imbalance of the patient within a third threshold amount of time, in view of the teachings of Moraitis, for the obvious advantage of being able to identify patient’s with a potassium deficiency so that they may be treated.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak, and further in view of U.S. Patent Application Publication No. 2013/0317316 to Kandeel.
For claim 9, Paz and Poltorak do not expressly disclose wherein the processor is further configured to generate one or more recommendations for treatment based, at least in part, on the disease prediction.
However, Kandeel teaches wherein the processor is further configured to generate one or more recommendations for treatment (para [0004]) based, at least in part, on the disease prediction (Examiner’s Note: claim 6 identifies that the claimed “disease prediction” can be “an indication of a presence of one or more diseases in the patient”) (see Fig. 4, which shows that “Exercise,” “Food optimization,” and “Drug therapy” are based on “Questionnaire,” and para [0035]-[0036] indicate that the questionnaire can include “diabetes diagnosis,”) (also see para [0031], which indicates that the ADAMS system can provide recommendations).
It would have been obvious to a skilled artisan to modify Paz wherein the processor is further configured to generate one or more recommendations for treatment based, at least in part, on the disease prediction, in view of the teachings of Kandeel, for the obvious advantage of treating the patient so that they can have their health improved.
For claim 10, Paz, as modified, further discloses wherein the one or more recommendations for treatment are generated further based on at least one of: a predicted effect of the one or more recommendations on kidney function of the patient; a predicted effect of the one or more recommendations on one or more conditions associated with the kidney of the patient (para [0036] Kandeel) (also see para [0002] of Kandeel).
For claim 11, Paz, as modified, further discloses wherein the one or more recommendations for treatment comprise at least one of: drug prescription recommendations; medical supplement recommendations; insulin dosage recommendations; invasive or non-invasive procedure recommendations; medical device recommendations for use by the patient; lifestyle modification recommendations; exercise recommendations; or diet modification recommendations (para [0004] of Kandeel).
For claim 12, Paz, as modified, further discloses wherein the insulin dosage recommendation comprises a recommended combination dosage of insulin and glucose (Examiner’s Note: this claim language being a further limitation on an alternative limitation previously recited in claim 11; because the alternative was not relied upon in the rejection of claim 11, the combination further satisfies this claim language since that another alternative is taught by the combination).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak, and further in view of U.S. Patent Application Publication No. 2021/0299353 to Mannu et al. (hereinafter “Mannu”).
For claim 16, Paz and Poltorak do not expressly disclose wherein the disease prediction is generated using a model trained using training data, wherein the training data comprises records of historical patients with varying stages of kidney disease.
However, Mannu teaches wherein the disease prediction is generated using a model trained using training data (para [0036]-[0037]), wherein the training data comprises records of historical patients with varying stages of kidney disease (para [0120], [0161], and [0182]).
It would have been obvious to a skilled artisan to modify Paz wherein the disease prediction is generated using a model trained using training data, wherein the training data comprises records of historical patients with varying stages of kidney disease, in view of the teachings of Mannu, for the obvious advantage of being able to diagnose kidney failure (see para [0005] of Mannu).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak, and further in view of U.S. Patent Application Publication No. 2021/0100533 to Seres et al. (hereinafter “Seres”).
For claim 17, Paz and Poltorak do not expressly disclose wherein the processor is further configured to: obtain at least one of demographic information, food consumption information, activity level information, medication information, health and sickness information, or disease stage information related to the patient; and wherein the disease prediction is generated further using at least one of the food consumption information, the activity level information, the medication information, the health and sickness information, or the disease stage information related to the patient.
However, Seres teaches wherein the processor is further configured to: obtain at least one of demographic information, food consumption information, activity level information, medication information, health and sickness information, or disease stage information related to the patient (para [0104]); and wherein the disease prediction is generated further using at least one of the food consumption information, the activity level information, the medication information, the health and sickness information, or the disease stage information related to the patient (para [0104]).
It would have been obvious to a skilled artisan to modify Paz wherein the processor is further configured to: obtain at least one of demographic information, food consumption information, activity level information, medication information, health and sickness information, or disease stage information related to the patient; and wherein the disease prediction is generated further using at least one of the food consumption information, the activity level information, the medication information, the health and sickness information, or the disease stage information related to the patient, in view of the teachings of Seres, for the obvious advantage of incorporating additional parameters/information to get a more accurate diagnostic output.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak, and further in view of U.S. Patent Application Publication No. 2006/0079740 to Silver et al. (hereinafter “Silver”).
For claim 19, Paz and Poltorak do not expressly disclose wherein determining the change comprises determining a rate of change of interstitial potassium levels from the first time period to the second time period based on the real-time data stream of estimated interstitial potassium values.
However, Silver teaches determining a rate of change of potassium levels from a first time period to a second time period (para [0067]).
It would have been obvious to a skilled artisan to modify Paz wherein determining the change comprises determining a rate of change of interstitial potassium levels from the first time period to the second time period based on the real-time data stream of estimated interstitial potassium values, in view of the teachings of Silver, because a rate of change is suitable way to determine “trend,” which is what Paz wants to already do.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak and Silver, and further in view of U.S. Patent Application Publication No. 2015/0141767 to Rogers et al. (hereinafter “Rogers”).
For claim 20, Paz, Poltorak, and Silver do not expressly disclose wherein determining the change comprises determining an upward or downward change in the interstitial potassium level from the first time period as compared to the second time period.
However, Rogers teaches wherein determining the change comprises determining an upward or downward change in the potassium level from the first time period as compared to the second time period (see Fig. 34) (also see [0082] and [0553]).
It would have been obvious to a skilled artisan to modify Paz wherein determining the change comprises determining an upward or downward change in the interstitial potassium level from the first time period as compared to the second time period, in view of the teachings of Rogers, because a rate of change is suitable way to determine “trend,” which is what Paz wants to already do.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paz in view of Poltorak, and further in view of U.S. Patent Application Publication No. 2016/0256063 to Friedman et al. (hereinafter “Friedman”).
For claim 21, Paz and Poltorak do not expressly disclose wherein a baseline interstitial potassium level in the first time period comprises an average interstitial potassium level of the patient during the first time period.
However, Friedman wherein a baseline potassium level in the first time period comprises an average potassium level of the patient during the first time period (para [0080]).
It would have been obvious to a skilled artisan to modify Paz wherein a baseline interstitial potassium level in the first time period comprises an average interstitial potassium level of the patient during the first time period, in view of the teachings of Friedman, for the obvious advantage of reducing errors from individual measurements to get a more accurate diagnostic output.
Response to Arguments
Applicant’s arguments filed 1/14/26 have been fully considered.
With respect to the claim objections, Applicant’s amendments and arguments are persuasive and the objections are withdrawn.
With respect to the 112 rejections, Applicant’s amendments and arguments are persuasive with respect to some of the rejections. Rejection(s) being maintained appeared to not have been addressed in the amendment.
With respect to the 101 rejections, Applicant’s amendments will be treated in the order they were presented. With respect to the first argument, this argument is conclusory. Performing steps such as “process,” and/or “determine” are types of steps that can reside in the human mind. The human mind makes determinations and performs processes everyday. With respect to the second argument, the claimed subject matter does not offer a tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. With respect to the third argument, this argument is conclusory as well. The response does not provide rational underpinning as to what subject matter is “significantly more” or why it is “significantly more.”
With respect to the 102 rejection, Applicant’s arguments have been considered but are moot because the arguments do not address the new grounds of rejection necessitated by Applicant’s amendments presented in the response filed 1/14/26. However, to address claim 2, both claims 1 and 2 are apparatus-type claims. Therefore, structure is given more patentable weight that purpose/function. (see page 12 of the response, which argues that Paz and Van Antwerp “serve entirely different purpose”). Here, even if the purposes are different, Paz and Van Antwerp use the same category of structures: electrodes. Similarly, they are both sensing analytes present in a fluid medium. Accordingly, even if one is urine and one is blood, a skilled artisan would expect that Van Antwerp’s electrode structure could modify Paz’s electrode structure (since they are both electrodes, that’s not too far of a jump) to sense analytes in whatever bodily fluid media that are placed in and/or adjacent to (whether that’s urine, blood, or could also work in other bodily fluids like saliva). Therefore, the differences highlighted in the response prove to be immaterial. Additionally, arguments such as Paz disclosing that glass capillaries, selective membranes, and coaxial shielding are used are not negated by Van Antwerp’s structure. That is, modifying Paz in view of Van Antwerp doesn’t get rid of any of those things, it only adds to it. As a result, no evidence of inoperability is present in either of these references and Applicant is reminded that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). And, “KSR does not require that a combination only unit old elements without changing their respective functions. . . . Instead, KSR teaches that ‘[a] person of ordinary skill is also a person of ordinary creativity, not an automation.’ And it explains that the ordinary artisan recognizes 'that familiar items may have obvious uses beyond their primary purposes, and in many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.” ClassCo v. Apple, slip op., at 8 (quoting KSR v. Teleflex) (Fed. Cir. 2016). Therefore, a skilled artisan will be able to recognize that Van Antwerp can be used beyond its primary purpose and incorporated in a urinary potassium sensor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
Prosecution Insights