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 .
Detailed Action
Summary
This is the Final Office action based on the 17/494444 in response filed 01/20/2026.
Claims 1, 3, 5-19 are pending.
Claims 1, 3, 5-18 are examined and have been fully considered.
Claims 2 & 4 have been cancelled.
Claim 19 is withdrawn.
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.
The claimed invention of Claims 1, 3, 5-18 are directed to an abstract idea/law of nature/natural correlation without significantly more. The claim(s) recite(s) the abstract idea/law of nature which as claimed is the claimed, “analyzing and judging,” as one of “negative, positive, false positive,” of “primary aldosteronism.” This is a natural correlation/ abstract idea which is the ARR value and it’s correlation with primary aldosteronism. This judicial exception is not integrated into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 2A, Prong One: Identify the judicial exceptions (law of nature/natural phenomenon/abstract ideas).
Independent Claim 1 recites “analyzing and judging” as “one of,” “results,” of “primary aldosteronism,” disease. Analyzing and judging as claimed are mental processes which are abstract idea type of judicial exception. Further- the correlation between ARR and primary aldosteronism is a natural correlation which is a law of nature judicial exception. Though the word “diagnosis,” or diagnosing is not used---- and the method is done to determine a result of primary aldosteronism (a disease or condition), the diagnosis is still there.
Further in claim 1, there is a “combining,” step- however all that is claimed is “combining a concentration of aldosterone with the production rate of angiotensin I” This kind of “combining,” is just math/a mathematical process/addition. Therefore, this is also an abstract idea.
Step 2A Prong Two: Has the abstract idea been integrated into a particular practical application?
For Claim 1, the answer is no.
The claimed detection using LC- MS/MS is done to gather data to perform the judicial exception and therefore is extra solution activity. See MPEP 2106.05 (g).
This remains the case when taking into account that the detection is for “production rate of angiotensin I and hypertension therapeutics,” since the detection is just done in a plasma sample and further there is no actual dosing of therapeutics done in the claims. Even if the dosing were done in the boundaries of the claim, it would seemingly ben done before the claimed incubation, and not instead as a result of determination of the judicial exception--- so therefore would not practically apply the judicial exception.
Step 2B: Do the claims recite any elements which are significantly more than the abstract idea?
Here, we look to the elements other than the abstract idea and law of nature/natural correlation to see if there is significantly more.
As outlined above all of the claimed steps including the “combining,” “analyzing,” and “judging,” are interpreted as mental or mathematical processes so are abstract ideas.
The claims include mention of other things like “liquid chromatograph-tandem mass spectrometry,” and “therapeutics influencing ARR,” and that the detection is for “production rate of angiotensin I and hypertension therapeutics,” none of these things are actively used or administered in the instant claims and the detecting as claimed can still be reading off a chart. The requirement that the detecting is done “in a plasma sample,” does not change matters. Further the recitation of what the what the hypertension therapeutics are does not change the analysis above as is just further specifying what is detected, since they are just detected in a natural plasma sample.
Further, using plasma samples, and LC-MS-MS are well understood, routine and conventional (WURC) in the art as is detecting biomarkers in these types of samples. Therefore, the additional elements do not amount to significantly more. Things that are WURC are not considered to add significantly more. See MPEP 2106.05(d) II.
The dependent claims undergo the same analysis.
Claim 3, recites that the ARR is computed/calculated using a specific formula. The claimed formula is still a simple mathematical equation and calculation. Therefore, this remains an abstract idea.
Claims 5-7 specifies properties of the therapeutics and are analyzed the same as the therapeutics in Claim 1. They further specify that a clinical medication AI guidance system is used, which itself contains two modules and a decision tree system. At the level of generality claimed, all these things are WURC and therefore not enough to make the claims a practical application as step 2A/2 or be significantly more at 2B. No specific computer or processor is claimed as being specially “programmed to,” or “configured to.”
Claim 8 depends on Claim 7 so carries that analysis. Claim 8 further specifies that production rate of angiotensin I is calculated using a claimed formula and using an incubation time. The claimed formula is still simple math so and abstract idea. Further incubation times and their use in measuring “rates,” are WURC. Therefore, there is no practical application as step 2A/2 or be significantly more at 2B.
Claim 9, attempts to further limit the detecting from Claim 1. Though Claim 9 is long, everything in 1) is very generalized and WURC laboratory analysis and therefore does not change the matters above. 2) just specifies how many compounds are detected, 3) specifies that standards are used and these in addition to the other things in 3) are WURC so does not change the matters above.
Claim 10 specifies that zinc sulfate, methanol, and an isotope are used for analysis. However, nothing is claimed about any interaction with the sample or derivatization. Therefore, this all reads on extra-solution activity and therefore does not practically apply nor adds significantly more.
Claim 11 specifies that a generation buffer is used that contains PMSF, Tris, and EDTA and that formic or acetic acid is used. However, nothing is claimed about any interaction with the sample or derivatization. Therefore, this all reads on extra-solution activity and therefore does not practically apply nor adds significantly more.
Claim 12 specifies that specifies that standards are used. These are WURC so does not change the matters above.
Claim 13 does not add significantly more for the same reasons as Claims 9-12.
Claim 14 contains specific mobile phrase times and flow rates. This seems more specific and like it might help overcome 101 however, does not currently as mobile phases are not required in Claim 9 which claim 12 depends on, nor is it found in any of the claims before this.
Claim 15 is rejected for the same reasons as Claim 14. Though it seems more specific, these limitations are not clearly required by the claims due to antecedent basis/112 issues.
Claims 16-17 are rejected by virtue of being dependent on Claim 1. The limitations in Claims 16-17 could the detection, if detection were positively written as required in the independent claim significantly more, however not as a dependent claim since it carries the analysis of Claim 1.
Claim 18, does not change the matters above. All that is claimed in Claim 18 is something “can influence,” but it does not mean that it does. Further Claim 18 claimed that “can be,” analyzed by AU software. Again- this doesn’t require that anything is analyzed by AI software, so does not change the matters above. Even if claimed as required, this would not change things as AI software is WURC.
All claims are rejected under 101.
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.
Claims 1, 3 & 5-18 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.
With respect to Claim 1—the claim preamble requires “medicaments influencing aldosterone-to-renin (ARR),” however the claim body requires “hypertension products influencing ARR.” These are not exactly the same thing and indicate different scope. Applicant should amend the claims to promote clarity, as it is not clear if they are the same or different things.
Further with respect to Claim 1, the preamble requires, “during detection of plasma renin activity,” however nowhere in the claim body do the claims indicate that plasma renin activity is actually detected or measured. Correction is required to fix this as it is unclear what the claims require.
Even further with respect to Claim 1, it is claimed, “combining a concentration of aldosterone with the production rate of angiotensin I to obtain an ARR value,” however it is not claimed anywhere is a concentration of aldosterone is measured. How is the concentration of aldosterone found if it is not measured? Or instead, is the “combining,” just some kind of standard concentration of aldosterone used for the equation to obtain an ARR value. This is not clear and requires correction.
Further with respect to Claim 1- combining a concentration (of aldosterone) and a rate (of production of angiotensin I) would not have the same units as concentration for example could be in ng/ml and rate could be in ml/min. Therefore, it is unclear how they are combined / “combining,” into and aldosterone-to-renin ratio since they have different unit. Further--- it’s unclear how an “aldosterone- to-renin,” ratio could even be found since as claimed it does not seem like renin is measured anywhere, and further aldosterone also is not measured anywhere.
Further, it is unclear with respect to Claim 1, what is going on in the claim is unclear as it claims that the ARR value (which is a combination of production rate of angiotensin I and aldosterone) and is analyzed and judged, “analyzing and judging,” “based on a result of the detecting of the presence of hypertension therapeutics.” How is one value judge “based on,” another. As claimed- this does not make sense and is unclear. It is assumed that some type of correlation between the two values indicate the claimed negative, positive, false negative, or false positive results of primary aldosteronism (PA) screening, but this is not clear form the claims. It is also not clear how or if “analyzing,” is any different from “judging,” as both terms are claimed. Applicant should also review the dependent Claims for where “analyzes and judges,” or similar is claimed and make corrections throughout the claim set with respect to this.
Correction is required for all of the issues above.
With respect to Claim 3, it is unclear since the formula requires “concentration of aldosterone,” when or if it is measured or detected. It is not claimed as being measured or detected, so this is unclear.
With respect to Claim 5, “increase,” and “decrease,” are relative terms which are not defined by the claim and therefor these terms are unclear in the claim language.
With respect to Claim 5, it is unclear if the claimed “analyzing and judging,” is supposed to refer back to the analyzing and judging claimed in Claim 1 or not since no “the,” is used before it. If it is meant to be the same thing, it fails to have proper antecedent basis.
With respect to Claim 6, “basic,” in “basic information,” is a relative term and not defined by the claim. Each different person reading this term would assume it means something slightly different. Therefore, it is unclear in the claim and requires correction.
With respect to Claim 6, applicant uses, “ARR index,” however Claim 1 and Claim 7 use “ARR value.” It is unclear if applicant means the same thing by these terms.
With respect to Claim 7, it claims “medicament capable of increasing ARR,” however Claim 6, 5, and 1 which is depends from indicated that these medicaments are hypertension therapeutics. So, what applicant is referring to in Claim 7 is unclear. Applicant should amend claims to be consistent with the terminology used in Claim 1.
With respect to Claim 9, “detecting, by LC-MS/MS,” fail to have proper antecedent basis as this was referred to in Claim 1 already so without “the,” it is unclear if applicant is referring back to that detection or not.
Further for Claim 9, in the second to last paragraph from the bottom, “screening for hypertension therapeutics,” it is unclear if these are the same hypertension therapeutics used in Claim 1 or not.
It is also unclear for Claim 9, in the second to last paragraph from the bottom if the “high performance liquid chromatography tandem mass spectrometry system,” is attempting to further clarify the LC- MS/MS used in Claim 1 or not as it is not claimed as referring back or further comprising in any way.
Even further with respect to Claim 9, it is not clear if the last paragraph, staring in “a double check is necessary,” is a positive claim step or not and it is also unclear if what is in quotations in the claim---“a mixed medicament-screening working solution,” --- is required or if it is just exemplary. Further- the same issued with respect to “medicament,” versus, “hypertension therapeutics,” is present in this claim as it was in earlier claims. Even further with respect to Claim 9, it is unclear how or if applicant can actually “thus ensuring the accuracy,” as this seems to only be a result and speculative and not a clear method step.
With respect to Claim 13, “evenly,” is a relative term that is not described by the claim and is therefore unclear.
With respect to Claim 15, “the standard substance,” is unclear as to what it refers back to. Is it the “internal standard,” referred to in Claim 9.
With respect to Claim 16, it is unclear if applicant is referring back to the HPLC-MS/MS detection in Claim 9 or the LC/MS/MS detection referred to in Claim 1 by “the detecting by LC-MS/MS.” As claimed, this fails to have proper antecedent basis.
All other dependent claims are rejected by virtue of being dependent on Claim 1.
Claim Objections
Claims 3 ,5,6, 13-14 & 18 are objected to because of the following informalities:
With respect to Claim 3, it refers back to Claim 2, which was cancelled. It is assumed that this is a typo and is supposed to be dependent on Claim 1.
With respect to Claim 5, it refers back to Claim 4, which was cancelled. It is assumed that this is a typo and is supposed to be dependent on Claim 1.
With respect to Claim 6, “the information module,” is assumed to be the “patient information module,” used in Claim 5. Applicant should amend claim to indicate this and used the same terminology throughout the claim set for clarity’s sake.
With respect to Claim 13, “the incubation refers that,” should be “the incubation refers to that.”
With respect to Claim 14, applicant refers to “the liquid chromatography.” It is assumed that applicant means the HPLC referred to in Claim 9, but applicant should clarify since just “liquid chromatography,” is referred to in Claim 1.
With respect to Claim 18, it says, “any one of claims 1.” Further it says, “hypertension medicaments,” which Claim 1 says, “hypertension therapeutics.” It is assumed this is a typo and required correction.
Appropriate correction is required.
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.
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 non-obviousness.
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.
Claims 1, 3, 5-18 are rejected under U.S.C. 103 as being obvious by POGLITSCH in US 20160266151 in view of TRAN in US 20180001184.
With respect to Claim 1, POGLITSCH teaches of methods and kits for the diagnosis of primary hyperaldosteronism (PHA). In particular, the present invention relates to the use of a new diagnostic parameter that is composed of the ratio between the Ang II level, in particular the steady state equilibrium Ang II level, and the aldosterone level in a biological sample, such as e.g. plasma (abstract).
POGLITSCH further teaches of measuring the ARR (which stands for aldosterone to renin ratio) (paragraph 0003) and that measuring can be done by liquid chromatography tandem mass spectrometry (paragraph 0022-0023, 0106).
POGLITSCH further teaches that a plasma sample is used and that also quality control samples are used and internal standards (abstract, paragraphs 0106-0107).
POGLITSCH further teaches of detecting whether an ARR influencing drug is present wherein the RAS interfering drug is one such as Lisinopril, capropril, aliskiren, amastatin, angiotensin converting enzyme 2 (ACE2), neutral endopeptidase, also called neprilysin (NEP) (paragraph 0070).
POGLITSCH also teaches of measuring angiotensin II or (Ang 1-8)(paragraph 0001, 0008, 0021, 0098) and of determining the production rate of it (paragraph 0084- 0085) and also of measuring aldosterone concentration (paragraph 0003, 0011, 0074).
POGLITSCH does not specifically teach of detecting and monitoring medications effects on the disease or markers thereof.
TRAN is used to remedy this. TRAN teaches of an Internet of Things device (abstract). TRAN further teaches of using the device to monitor treatment data, and treatment response from a patient population among other things (paragraph 0003). TRAN even further teaches of using the device to monitor hypertension, primary aldosteronism (paragraphs 0224-0244), and further of monitoring the drugs and therapeutics used to treat, control, and alleviate hypertension (paragraph 0286). TRAN also teaches of the device analyzing the treatment and giving feedback on the treatment and treatment drugs (paragraph 0298, Table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to monitor the drugs and treatment to see if they have adverse consequences as is done in TRAN in the method of POGLITSCH due to the advantages this offers in lower costs and side effects that come about due to adverse side effects of drugs (TRAN, paragraph 0005).
With respect to Claim 3, POGLITSCH teaches of measuring the ARR (which stands for aldosterone to renin ratio) and specifically that the formula is the mass concentration of aldosterone divided by the renin activity (rate of renin production) and or renin concentration in blood plasma (paragraph 0003).
With respect to Claims 5-7, POGLITSCH teaches of an ARR influencing drug being an RAS interfering drug such as Lisinopril, capropril, aliskiren, amastatin, angiotensin converting enzyme 2 (ACE2), neutral endopeptidase, also called neprilysin (NEP) (paragraph 0070). The claimed “results,” are material properties of the drugs so if the drugs are taught, these possible results are as well.
TRAN further teaches of the device including an Internet of Thing (IoT) device includes a camera coupled to a processor; and a wireless transceiver coupled to the processor. Blockchain smart contracts can be used with the device to facilitate secure operation This can be read as an AI guidance system through broadest reasonable interpretation.
TRAN further teaches of using a database (database module) with a patient profile (patient information module), (paragraph 0289, 0288) and of storing multiple algorithms to analyze metrics (paragraph 0290-0297). TRAN further teaches of using a decision tree (paragraph 0215, 0385-0386).
With respect to Claim 8, POGLITSCH teaches of measuring the levels of angiotensin II or other peptide degradation product. The sample is incubated until steady state is reached and then the concentration is quantified in the sample (paragraph 0075, 0079). POGLITSCH further teaches that Ang I, is also a peptide degradation product, making it obvious to measure after incubation (paragraph 0084). This makes Claim 8 obvious.
With respect to Claim 9, POGLITSCH teaches of pretreating the sample (paragraph 0083, 0103, 0108, 0125), using internal standards (paragraph 0098, 0102), using formic acid which can be used as a terminating solution (paragraph 0100), incubating (paragraph 0075, 0079), and centrifuging/precipitating/vortexing and then using the resultant (supernatant) for mass spec liquid chromatography (paragraph 0022). The parameters can be optimized through routine experimentation. See MPEP 2144.05
With respect to Claim 10, POGLITSCH teaches of using methanol (paragraph 0104), sulfates (paragraph 0082, 0096), and isotopic internal standards (paragraph 0102).
With respect to Claim 11, POGLITSCH teaches of using EDTA in a protease inhibitor cocktail (paragraph 0080-0081, 0095, 0100, 0130), and further of using PMSF (paragraph 0100), and Tris (paragraph 0099), and further of using formic acid (paragraph 0100).
With respect to Claim 12, POGLISTCH teaches of using standards (paragraph 0098, 0102) POGLITSCH and TRAN do not teach of medication standards specifically, however there are large 112 issued with the part of Claim 9 where this is introduced so the standards of POGLITSCH can be interpreted as these as the claims are unclearly claimed.
With respect to Claim 13, POGLITSCH teaches of incubating at 37 degrees Celsius for 30 minutes and 60 minutes (paragraph 0160, 0168). POGLITSCH further teaches of collecting sample over a few weeks, so this can read on before and after the claimed incubation (paragraph 0166).
With respect to Claims 14-15, POGLITSCH teaches of pretreating the sample (paragraph 0083, 0103, 0108, 0125), using internal standards (paragraph 0098, 0102), using formic acid (paragraph 0100), and methanol (paragraph 0104). POGLITSCH does not teach of the claimed mobile phase or the retention times claimed, but as the claims LC/MS/MS is taught, these parameters can be optimized through routine experimentation. See MPEP 2144.05. POGLITSCH does not teach of all the claimed drugs.
With respect to Claims 16-17, POGLITSCH teaches of using the device in MRM mode and using a triple quadrupole MS (paragraphs 0160-0162). POGLITSCH does not teach of the information found on the table in Claim 16 or 17, but as shown above in the 112 rejections, the claim is very unclear. So as best understood, these conditions for mass spectrometry are considered taught or at least made obvious as they are optimizable through routine experimentation.
With respect to Claim 18, POGLITSCH teaches of an ARR influencing drug being an RAS interfering drug such as Lisinopril, capropril, aliskiren, amastatin, angiotensin converting enzyme 2 (ACE2), neutral endopeptidase, also called neprilysin (NEP) (paragraph 0070). The claimed “results,” are material properties of the drugs so if the drugs are taught, these possible results are as well.
TRAN further teaches of the device including an Internet of Thing (IoT) device includes a camera coupled to a processor; and a wireless transceiver coupled to the processor. Blockchain smart contracts can be used with the device to facilitate secure operation This can be read as an AI guidance system through broadest reasonable interpretation.
TRAN further teaches of using a database (database module) with a patient profile (patient information module), (paragraph 0289, 0288) and of storing multiple algorithms to analyze metrics (paragraph 0290-0297). TRAN further teaches of using a decision tree (paragraph 0215, 0385-0386). From the combination of these two things it would have been obvious that the influences of medication of AAR “can be analyzed and predicted by AI software.” It would have been obvious to one of ordinary skill in the art to monitor the drugs and treatment to see if they have adverse consequences as is done in TRAN using the internet of things and AI, in the method of POGLITSCH due to the advantages this offers in lower costs and side effects that come about due to adverse side effects of drugs (TRAN, paragraph 0005).
It is noted that all of the instant claims are very unclear and confusing. Therefore, though some of the claims currently contain a great deal of detail, it is not clear much of what is limiting and much of what is not as they are currently claimed. It is suggested that applicant go through these claims and significantly clarify matters with amendments.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive.
The prior 101 rejection is maintained for claims as amended 01/20/2026. Though the applicant has added detection to the claim body, it now also seems that the claimed are diagnostic for “primary aldosteronism,” so the claims are read as encompassing a natural correlation judicial exception as shown above.
Some of the prior 112 (b) rejections are overcome due to amendments dated 01/20/2026 however some are maintained and further ones are made due to amendments dated 01/20/2026 as shown above.
Some of the prior objections have been overcome due to amendments made 01/20/2026 however due to amendments dated 01/20/2026 more are shown on the record above.
With respect to the 101 rejection, applicant argues that the instant claimed require physical steps, and employs specific analytical technology (incubation and LC-MS/MS). With respect to this, the examiner notes that “physical steps,” and “incorporation of analytical technology,” are not the test to determine whether the claims amount to significantly more than a judicial exception. The examiner notes the LC/MS/MS and incubation are well understood, routine and conventional in the art, especially at the level of generality claimed. Therefore, this is not found to be significantly more than the claimed judicial exception.
Further, with respect to the 101, applicant argues that the claimed integration of detection of interfering drugs with the calculation of ARR improves diagnostic accuracy and avoid unnecessary drug wash out periods, and that this is a practical application.
The examiner notes, that as claimed--- this is not considered to be a practical application in light of US practice law with respect to subject matter eligibility, especially with respect to how generally the claims are written. In fact, in the claims--- no steps are performed after the instant abstract idea or mental process of analyzing or judging if the patient has primary aldosteronism is performed. Since nothing is performed after this step in the claim--- there is no practical application of the judicial exception.
Further—with respect to the hypertension therapeutics which are claimed as being detected. The claim does not require that all of the claimed therapeutics actually be detected, but instead only that a plasma sample is screened or it’s seen if the plasma sample has the therapeutics or a subset thereof in it. Therefore, there is no practical application here, but instead merely a plasma sample is screened. While the examiner understands that there might be more with respect to the invention---- the rejections in the action are made based on exactly what is claimed, and the broadest reasonable interpretation of the claims. Things which are not in the claims, for example applicants claim of avoiding unnecessary drug washout periods, are not read into the claims.
Therefore, all claims remain rejected under 101.
With respect to the 103 rejection applicant argues that POGLITSCH teaches away from AAR base diagnosis in favor of AA2R.
First of all--- the examiner notes that it seems here that applicant is arguing that their instant method is for an ARR based diagnostic method. The examiner notes that for 101 purposes, diagnostic claims without practically applying the judicial exception or adding significantly more--- are considered to be patent ineligible.
Further- with respect to the 103 rejection, the examiner disagrees with applicant that POGLITSCH’s teaching of AA2R diagnoses teaches away from AAR diagnoses. Even though yes the examiner sees that POGLITSCH teaches of AA2R, they also teach of AAR and diagnoses related to this. Therefore, this teaches of the instant claims.
Applicant further argues that neither POGLITCH or TRAN teach of synchronous LC MS/MS detection of a defined panel of 43 antihypertensive drugs during renin activity to flag results. With respect to this, the examiner notes that what is required by the claim is that there is detection for medicaments influencing ARR, and not that ALL 43 hypertension related or anti-hypertension therapeutic are detected. All that is required is that a sample is screened for some of them. The prior art does in fact teach of this as shown in the prior art rejection above.
Further with respect to the prior art, applicant argues that the claimed method solves a specific, unmet clinical problem of avoiding risky drug wash out periods while improving ARR accuracy. Applicant argues that neither POGLITSCH or TRAN teach of this. With respect to this--- the examiner notes that this argument is not commensurate in scope with the instant claims. Since this material is not claimed, the prior art is not required to teach of it.
All claims remain rejected under 103.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday.
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/REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758