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 .
Remarks
This Office Action fully acknowledges Applicant’s remarks filed on March 15th, 2025. Claims 1-2, 7, 9-16, and 18-21 are pending. Claims 3-6, 8, and 17 are canceled.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The amended claims recitations as presented herein lack proper antecedent basis in the specification, and are not found in Applicant’s cited support of pages 49, 61, 81, fig. 9 and examples 2 and 3 (see page 8 of Applicant’s remarks filed March 15th, 2026).
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.
Claims 1-2, 7, 9-16, and 18-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The claim(s), individually and as an ordered combination, recite(s) abstract ideas in the form a natural correlation (law of nature), mathematical concepts, and mental steps in determining whether a subject has hypertension and possible early renal damage hypertension as seen through calcitriol to 24,25-dihydoxyvitamin D to calcifediol ratio below cited thresholds and connection with a subject having hypertension and possible early renal damage, along with the calculating of the recited proportion ratio in step d. and the determination in step e. as in claim 1 that amount to steps involving math and mental steps in making a calculation and subsequent assessment of a result against a threshold value.
This is likewise seen with respect to independent claim 13 with respect to the natural correlation (law of nature) in calcitriol to 24,25-dihydoxyvitamin D to calcifediol ratio below cited threshold, and to step c. (math/metal step by “calculating”) and step d. (math/mental step in “determining”).
This is likewise seen with respect to independent claim 18 with respect to the natural correlation (law of nature) in calcitriol to 24,25-dihydoxyvitamin D to calcifediol ratio below cited threshold, and to step c. (math/metal step by “calculating”) and step d. (math/mental step in “determining”).
This is drawn to Step 2A, Prong 1 (i.e. judicial exception/abstract idea portion) of the analysis.
As in Step 2A, Prong 2 (i.e. integration into a practical application) -
This/these judicial exception(s) is(are) not integrated into a practical application because:
In claim 1 - steps a. and b. and c. are drawn to general data gathering through routine and conventional means and general sample provision.
Further, steps f. and g. are recited at a high level of generality and breadth and amount to insignificant extra-solution activity, wherein such generalized steps are ordinary when assessing for a disease or a disorder and are not unique to the abstract idea at-hand.
Similarly, as in claim 13 – steps a. and b. are drawn to general data gathering through routine and conventional means and general sample provision.
Further, step e. is recited at a high level of generality and breath and amounts to insignificant extra-solution activity as such a step is drawn to ubiquitous prophylaxis carried out by a practitioner when assessing a disease or disorder and is not unique to the abstract idea at-hand. This is likewise seen in dependent claims 14 and 16, in which such “administering a treatment…” is not particular and is a highly generalized without detail thereto, and that is ubiquitous to prophylaxis provided by a practitioner.
Similarly, as in claim 18 – steps a. and b. are drawn to general data gathering through routine and conventional means and general sample provision.
Further, the step of “administering a treatment to the subject” is recited at a high level of generality and breath and amounts to insignificant extra-solution activity as such a step is drawn to ubiquitous prophylaxis carried out by a practitioner when assessing a disease or disorder and is not unique to the abstract idea at-hand. This is likewise seen in dependent claim 20, in which such “treatment” is not particular and is a highly generalized without detail thereto, and in which “behavior modification” is not a treatment, and wherein such terminology at best amounts to general prophylaxis.
Herein, all of the claims do not provide a particular treatment or prophylaxis and instead are drawn to generalized application.
See also MPEP2106.04(d)(2) which states:
The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application.
The following case law, which has been previously provided on the record, is pertinent to this area as well -
Examiner further notes 887 F.3d 1117 (Fed. Cir. 2018) “Vanda Pharm,” and 919 F.3d 1347, 1356 (Fed. Cir. 2019) “Endo Pharm,” as providing cases in which the claims incorporated additional features related to treatment and were deemed patent eligible.
As can be seen from the Decisions in these cases and their corresponding patent claims, the claims in “Vanda Pharm” and “Endo Pharm” provide particular treatment steps in connection with the discovery.
“Endo Pharm” provides a particular method of treatment with a particular dosage regimen that avoids possible issues in dosing and allows for treatment with the lowest available dosage for patients with renal impairment (see claim 1, for example, USPN 8,808,737).
Similarly, in “Vanda Pharm,” in the method of treating schizophrenia patients with a drug (iloperidone), where the administered dose is adjusted based on whether or not the patient is “CYP2D6 poor metabolizer.” The inventors in “Vanda Pharm” discovered that the treatment of CYP2D6 poor metabolizers can be accomplished more safely by administering a lower dose of the drug than would be administered to a person who has normal CYP2D6 enzyme activity. Therein, “Vanda Pharm” patent claims refer to a reduced dose of iloperidone for poor metabolizers compared to typical metabolizers alongside the genotyping assay (see claim 1, for example, USPN 8,586,610).
Further, as in MPEP 2106(d)(2)-
The treatment or prophylaxis limitation must have more than a nominal or insignificant relationship to the exception(s). For example, consider a claim that recites a natural correlation (law of nature) between blood glucose levels over 250 mg/dl and the risk of developing ketoacidosis (a life-threatening medical condition). The claim also recites "treating a patient having a blood glucose level over 250 mg/dl with insulin”. Insulin acts to lower blood glucose levels, and administering insulin to a patient will reduce the patient’s blood glucose level, thereby lowering the risk that the patient will develop ketoacidosis. Thus, in the context of this claim, the administration step is significantly related to the recited correlation between high blood glucose levels and the risk of ketoacidosis. Because insulin is also a “particular” treatment, this administration step integrates the law of nature into a practical application. Alternatively, consider a claim that recites the same law of nature and also recites “treating a patient having a blood glucose level over 250 mg/dl with aspirin.” Aspirin is not known in the art as a treatment for ketoacidosis or diabetes, although some patients with diabetes may be on aspirin therapy for other medical reasons (e.g., to control pain or inflammation, or to prevent blood clots). In the context of this claim and the recited correlation between high blood glucose levels and the risk of ketoacidosis, administration of aspirin has at best a nominal connection to the law of nature, because aspirin does not treat or prevent ketoacidosis. This step therefore does not apply or use the exception in any meaningful way. Thus, this step of administering aspirin does not integrate the law of nature into a practical application.
Herein, as in the independent claims 1, 13, and 18, the treatment is not particular as previously discussed above and as it pertains herein to the above-cited section as the claims lack a particular treatment let alone a particular treatment with more than a nominal or insignificant relationship to the exception.
Most pertinently, the above section pertains to that of claim 9.
At the outset, it is noted that “administering behavioral modification” does not suffice in providing a particular treatment as it is a highly generalized application that is not unique to the law of nature/abstract idea and has only nominal correlation therewith and further, such a step does not amount to an administration in and of itself as “behavioral modification” is not a drug/medication and a drug/medication with particular correlation to the law of nature/abstract idea.
In the more relevant portion claim 9 recites “…administering from the group consisting of agonist of calcitriol…and any combination thereof.”
While these recitations allude to an administration, the recitations themselves do not provide a particular treatment nor one with more than a nominal or insignificant relationship to the exception(s).
First, the listed elements are not drugs or medications, let alone ones known with particular correlation to blood pressure and Vitamin D deficiency or imbalance.
The recitations amount to conceptual discussion (codifying each naturally occurring substances by way of agonist or antagonist) of the variables involved in the calculated ratio so as to affect either one of the numerator and denominator in order to increase the ratio above the cited threshold in each of the claims.
It is further seen that the treatment herein (ignoring “behavioral modification” for purposes of discussion) is not particular as the recited group is drawn to each of the naturally occurring substances being codified by both ‘agonist’ and ‘antagonist’ that implicitly provides an insignificant treatment as it encompasses all manners of manipulating the ratio and thus is arbitrary and non-particular.
It also remains that, as discussed above, these codified/nominally designated ‘agonist’, ‘antagonist’ to calcitriol, 24,-25-[]vitamin D, and calcifediol are not treatments and are not drawn to particular pharmaceuticals, medications with particular correlation to the law of nature/abstract ideas at hand, and instead are provided as conceptual descriptors.
This is further seen in par.[0160] of Applicant’s pre-grant publication US 2023/0058146 that is drawn to a laundry list of well-known over-the-counter drugs that are provided without particular correlation to the abstract ideas at-hand.
Further, with respect to claims 9 and 20 as it pertains to administering/treating by behavior modification, these are also abstract ideas themselves.
See MPEP 2106.04(a) Abstract ideas-
2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and
As in Step 2B (i.e. significantly more portion) –
Steps a-c as in claim 1; steps a-b as in claim 13; steps a-b as in claim 18. As discussed above are drawn to data gathering and sample provision steps that are routine, conventional, and well-known in the art and recited at a high level of generality.
Steps f-g. as in claim 1; step e. as in claim 13; step of “administering a treatment….” as in claim 18 as similarly discussed above is herein drawn to insignificant extra-solution activity that is a nominal application that effectively amounts to a general “apply it” constitution to the judicial exception wherein such steps are recited at a high level of generality and are not unique to the abstract idea at-hand.
Further, as in all of claims 1, 13, and 18, the natural correlation (law of nature) to the recited ratio has nothing further beyond its calculation and wherein the appended “treatment” or “administering” is not particular and without more than a nominal correlation to the natural correlation/abstract ideas.
See also - Limitations that the courts have found not to be enough to qualify as “significantly more” when recited in a claim with a judicial exception include:
i. Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984 (see MPEP § 2106.05(f));
ii. Simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d));
Examiner also notes that the recitations provided in claims 1, 13, and 18 at their conclusion to “wherein the method prevents…” (cl. 1), “wherein the method avoids…” (cl. 13), and “wherein the risk…following the treatment…” are nothing more than narrative, qualitative descriptors, and do not impart a practical application nor significantly more that the abstract ideas.
Further, the remaining dependent claims 2, 7, 10-12, 15, 19, and 21 do not suffice to provide a practical application of the abstract ideas nor are they drawn to significantly more than the abstract ideas.
The recitations of claims 2, 10-12, and 19 are drawn to a subject wherein these recitations read back to their respective sample obtaining step, which as discussed above, is drawn to routine and generalized sample provision in the biological assay, nor do the recitations provide further steps therewith that correlate and inform particular treatment methodology concordant with the abstract ideas at-hand, further wherein a particular subject is not part of the claim (and noting that humans per se are expressly prohibited from being patented; see The Leahy-Smith America Invents Act (AIA ), Public Law 112-29, sec. 33, 125 Stat. 284 (Sep. 16, 2011).
The recitations to claims 7 and 21 are drawn to a further qualitative descriptor to the overall determination and does not impart a practical application or significantly more than the abstract ideas.
The recitation of claim 15 is drawn to a statement of intended use that does not impart a practical application or significantly more than the abstract ideas.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 2, 4, 5, and 7-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant cites pages 49, 61, 81, figure 9 and Examples 2 and 3 of the specification as providing basis for the amendments to the claims.
The amended claims recitations as presented herein are not supported therein and cannot be found elsewhere, wherein such recitations are drawn to new matter in the clams.
The amended protocol (the steps a-g in cl. 1 and likewise as in cls. 13 and 18, and dependents thereof that set forth the sought methodology) is/are drawn to new matter that is not supported in the disclosure.
The specification is without sufficient and supported discussion to the steps provided in claims 1, 13, and 18, and dependents thereof, let alone to particulars as in the recited threshold ratio values as in 5.17 (cl. 1), 4.94 (cl. 13), and 5.17 (cl. 18).
Examiner notes discussion in the cited portions of the specification given by the Applicant’s representative to that of ancestry-adjusted measurements for C24CPR (the “ratio” as claimed) and inferential discussion to blood pressure and vitamin D’s potential involvement to renal issues, but the discussion is not to the particular steps recited herein and is drawn to general, narrative discussion and mentions of prior work related thereto.
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, 2, 4, 5, 7-12, and 18-21 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.
The metes and bounds of the method of claim 1 are indefinitely defined as the claim initially provides a step of “determining whether the subject has Stage 1 or Stage 2 hypertension by…” and which includes the step of e. “determining that the subject has hypertension and early renal disease when…” in which the initial step sets forth a particular determination of Stage 1 or Stage 2 hypertension and not to just general hypertension, and further, does not include particular steps therein correlated and connected with “early renal disease” so as to provide clear linkage as to its determination by the prior steps.
Step f. of claim 1 to “monitoring the subject for other clinical causes of hypertension due to chronic kidney disease and thyroid disorder” is indefinitely defined in its metes and bounds.
Initially, the phrase “other clinical causes of hypertension” is vague and indeterminate in what constitutes being monitored coincident with “other clinical causes,” and the specification is without clear discussion or definition to such terminology.
Further, the monitoring itself is unclear in its metes and bounds and indeterminate in the active step(s) that afford such. Related therewith, it is unclear the connection and correlation with “chronic kidney disease” and “thyroid disorder,” both of have which have not particular bearing or establishment in the present methodology.
With regard to claims 9 and 20, the recitations “administering behavioral modification” and “treatment comprises behavior modification” are indefinitely defined in their metes and bounds. The terminology itself is vague, indeterminate and drawn to contrived language, wherein the specification does not rectify this by providing disclosure thereto and setting forth a clear definition or metes and bounds as to what encompasses these recitations.
Further, these recitations are not understood in the context of administering and treatment as “behavior modification” indefinitely corresponds to something to be administered or qualified as treatment. The specification does not provide further discussion or clarification to this so as to apprise one of the metes and bounds.
Further, as in cl. 9, the recited Markush group listing to what is administered is indefinitely defined in its metes and bounds.
The recitations to all of the agonist/antaoginst of calcitriol, agonist/antagonist of 24,-25[]vitamin D, and agonist/antogins of calcifediol does not provide clear metes and bounds to what is being administered.
These recitations are drawn to qualitative descriptors to the naturally occurring substances set forth in the claimed ratio, and do not set forth clear metes and bounds as to an administered treatment, wherein such qualified terms do not provide to define pharmaceutical(s), drug(s), medicament compositions, etc. Further, the specification only provides general discussion thereto in likewise terms and with added discussion therewith that is also generic and does not suffice to provide clear metes and bounds to the administered treatment that corresponds with these generally-qualified terms (see pars.[0016,0159] of Applicant’s pre-grant publication US 2023/0058146). Discussion in par.[0160] to well-known over-the-counter drugs is without particular correlation to the terms at-hand and the sought methodology in terms of the recited ratio in assessing hypertension and renal disease and treatment thereof.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 2, 4, 5, and 7-21 have been considered but are moot in view of the new grounds of rection applied above in the body of the action.
Examiner acknowledges Applicants remarks with respect to the amended claims and the prior rejection of the claims under 35 USC 101, and directs Applicant above to the body of the action for a detailed discussion therewith in which the rejection has been updated to reflect the amendments made herein.
Examiner acknowledges Applicants remarks with respect to the amended claims and the prior rejection of the claims under 35 USC 112 a/1st, and directs Applicant above to the body of the action for a detailed discussion therewith in which the rejection has been updated to reflect the amendments made herein.
Examiner acknowledges Applicants remarks with respect to the amended claims and the prior rejection of the claims under 35 USC 112 b/2nd, and directs Applicant above to the body of the action for a detailed discussion therewith in which the rejection has been updated to reflect the amendments made herein.
Further, the Specification is objected to for the reasons discussed above in the body of the action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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/NEIL N TURK/Primary Examiner, Art Unit 1798
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