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.
Notice of Amendment
In response to the amendment(s) filed on 8/24/26, amended claim(s) 1-2, 10, and 18-21 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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 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 § 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 time period of the plurality of time periods to a second time period 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 transcutaneous 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 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 transcutaneous 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 time period of the plurality of time periods to a second time period 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 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, 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 a 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 in-vivo potassium levels from the first time period to the second time period based on the real-time data stream of estimated 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 in-vivo potassium levels from the first time period to the second time period based on the real-time data stream of estimated 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 of the in-vivo 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 of the in-vivo 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 of the in-vivo 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 in-vivo potassium level in the first time period comprises an average in-vivo potassium level of the patient during the first time period.
However, Friedman wherein a baseline in-vivo potassium level in the first time period comprises an average in-vivo 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 in-vivo potassium level in the first time period comprises an average in-vivo 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 8/24/26 have been fully considered.
With respect to the claim objection, Applicant’s amendments and arguments are persuasive and the objection is withdrawn.
With respect to the 112(f) invocation, the term “sensor” has been found to not connote structure in at least Desa IP v. EML Technologies, No. 06-1168 (Fed. Cir. 2007). Additionally, mentioning structure in the specification doesn’t mean that the claim language recites structure. That’s why the specification is consulted when the claim recites a nonce term, so that the corresponding structure can give scope to the claim language. As a result, the invocation is maintained.
With respect to the 112 rejections, Applicant’s amendments and arguments are and thus the rejections are withdrawn.
With respect to the 101 rejections, Applicant’s amendments will be treated in the order they were presented. With respect to the first argument, the claim language is broad enough to be two data points and therefore two numerical values. That is, a “data stream of estimated potassium values” is broad enough to be 2 potassium values. The human mind can determine 2 values. The same argument applies to the next argument since the claim language is broad enough to encompass 2 values. With respect to the next argument, “using a continuous potassium monitor, to provide kidney-health decision support and disease prediction” is not an improvement in technology, it’s an improvement in an abstract idea. The sensor itself is considered under step 2B and the abstract ideas that are considered under step 2A do not improve any technology. Instead, they are potentially a better way to make a diagnosis and making a diagnosis is a abstract idea because doctors can generate diagnoses in their minds. With respect to the next argument about the sensor not being generic, the sensor is treated under step 2B and the rejection provides evidence that it is well-known, routine, and conventional. The argument tries to import structure from the specification into the claim and then argue that that imported structure is not generic. However, claims are read in light of the specification without importing features from the specification into the claim.
With respect to the 103 rejection, Applicant’s arguments will be treated in the order they were presented. With respect to the first argument, the claimed “transcutaneous continuous potassium sensor” is being treated under 35 U.S.C. 112(f) and the corresponding structure given to this term is “a body, a working electrode, a reference electrode, and/or a counter electrode.” Therefore, if Paz teaches one of these elements (since the operator “and/or” is used, denoting alternatives), then it reads on the scope of the claim language under 35 U.S.C. 112(f). As a result, Applicant’s arguments are not commensurate in scope with the claim language. The argument(s) in the response focus on the intended use of the sensor (i.e., interstitial fluid vs. urine), but the claim is defined by its corresponding structure due to the 112(f) invocation. Additionally, if “transcutaneous” means that the sensor is required to be attached to the skin, then that would present 101 issues because now a living organism (i.e., the skin) is being required to infringe the claim. However, notwithstanding the above, it appears that if the claim was clarified such that structure is recited and the 112(f) invocation no longer applies, then Applicant’s arguments may be more persuasive. With respect to the next argument about the change in principle of operation, the same reasoning for the above argument applies here as well. Paz would not need to be modified in such a way because the scope of the 112(f) invocation covers what is disclosed in Paz. With respect to the next argument, the claim language recites “urinary potassium values that are representative…” with “representative” being the key word here. So the scope of the claim language is not that the values need to be actual levels of potassium in interstitial or blood, but just that the values have to be representative of those levels. Poltorak expressly discloses “Here it causes the reabsorption of sodium ions from the renal tubular fluid in exchange for potassium ions that are secreted from the blood plasma into the tubular fluid to exit the body via the urine” (para [0060] and “This creates an ionic concentration gradient which results in the reabsorption of sodium (Na.sup.+) ions from the tubular fluid into the blood, and secreting potassium (K.sup.+) ions from the blood into the urine (lumen of collecting duct)” (para [0063]). These urinary potassium values are “representative” of the potassium in the blood because the potassium are secreted from the blood into the urine. Therefore, since the potassium passes from blood to urine, the levels in the urine are going to “represent” the levels in the blood. With respect to the next argument, the motivation is not “to improve accuracy,” as argued on page 17 of the response. Instead, the rejection states “ensuring the diagnosis of the patient is accurate.” It’s not that it’s more accurate, it’s that accuracy is ensured and the rejection gives the example of the urine potassium values representing values that are actually in the patient (i.e., in the blood versus in urine that has voided from the patient).
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.
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.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
