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 October 20th, 2025. Claims 1-2, 4-5, and 7-21 are pending. Claims 3 and 6 are canceled. Claim 21 is newly added.
Request for Information under 37 CFR 1.105
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
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, 4, 5, and 7-21 rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) individiually and as an ordered cominbation recite(s) a natural phenomena to native biomarker/metabolite ratios that are utilized in a diagnosis, which are representative of a discovery and not of an invention, as well as being drawn to the abstract idea of assessing a level of a biomarker against a comparator in making a determination/diagnosis that may be accomplished by mental steps. Further, as in step. c., this “determination” is another recitation to the judicial exception itself in setting forth the biomarker as C2FCPR above or below around 10.3771. 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 portion) -
This/these judicial exception(s) is(are) not integrated into a practical application because steps a-b of “obtaining,” and “analyzing” are drawn to mere data gathering steps that are all recited at a high level of generality (and further noting herein that the “assay” involved in the “analyzing” is without particular, active steps that particularly provide for “…that specifically detects at least one biomarker…” that lends its high level of generality and breadth to the “assay” set forth herein).
Further, step f. to “administering a treatment…” does not amount to integration of the judicial exception(s) as it is drawn to insignificant extra-solution activity, as such a generalized step of “administering a treatment…” is a ubiquitous operation to take place when assessing for a disease or a disorder and is not unique to the abstract idea at-hand. This is likewise seen with respect to dependent claims 14 and 20 of independent claims 13 and 18, respectively (further noting that it remains that “administering a treatment for hypertension to the subject” in cl. 18 is highly generalized, with respect to a large field of application, and without particular, active steps corresponding therewith).
As in Step 2B (i.e. significantly more portion) –
Steps a-b. to “obtaining” and “analyzing,” to the above-discussed data gathering steps are themselves ones that are to routine, conventional, and well-known in the art recited at a high level of generality
Step d. “administering a treatment….” 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. As similarly discussed above, this “administering a treatment…” step is recited at a high level of generality and such a step of “administering a treatment…” is a ubiquitous operation to be carried out by all such practitioners with respect to a disease/disorder. This is likewise seen with respect to dependent claims 14 and 20 of independent claims 13 and 18, respectively.
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));
Further, the following case law is applicable:
The added step to “administering a treatment…” does not amount to significantly more than the discovery and remains as insignificant extra-solution activity as discussed above. This step is highly generic and lacks any particularity in the treatment, nor how it relates with the prior discovery, and amounts to a general desire to apply a treatment to an ailment as would be expected.
See also Ariosa Diagnostics, Inc. v. Sequenom Inc.788 F.3d 1371, 115 USPQ 2d 1152 (Fed. Cir. 2015) that was drawn to natural phenomenon and deemed ineligible.
And In re Bhagat, Fed. Appx. (Fed. Cir. 2018) CAFC Appeal No. 2016-2525 that was drawn to natural phenomenon and deemed ineligible.
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).
Examiner further notes that the above discussion as made with respect to claim 1 equivocally applies under all of Steps 2A, Prong 1, 2A, Prong 2, and Step 2B with respect to Independent claims 13 and 18.
Notably, independent claims 13 and 18 are likewise to that of claim 1 and without the above-discussed nominal “application” step in the “administering a treatment…”
Furthermore, to the above discussion, it is noted that independent claims 13 and 18 do not recite anything additional beyond the judicial exception itself and the extra-solution activity that is the data gathering (“obtaining,” and “analyzing”).
Further, as discussed above, the “determining…10.3771” represents a judicial exception itself in an assessment step that is drawn to a mental step of a user evaluating a result.
See also MPEP 2106.04(a)- Abstract Ideas
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
Further, the remaining dependent claims 2, 4, 5, 7-12, 14-17, and 19-21 are drawn to further mental step evaluations, insignificant extra-solution activity, generalized sample types that are ubiquitous, application of routine and well-known general techniques and amount to “using X” (i.e. various spectrometry, spectroscopy, and chromatography fields [i.e. HPLC/MS] of application and are not assays as would be construed by a set of particular active steps recited to the methodology) without providing particular, active step(s) the method at-hand that functionally provide for the specific biomarker recited. Further, discussion to the subject (and their genetic variation) and their gender has no particular bearing and correlation within the active steps of the claimed methodology at-hand.
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 ejected 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 “Example 2” as providing basis for the amended recitation “the C24CPR level is above or below around 10.3771,” however, no such support is found thereat nor within the remainder of the specification.
Examiner notes that “Example 2” spans many pages in going from page 55 to page 80 of the specification, and within, many tables and values are presented in which the above-discussed recitation is not found and including with a numeral search with querying software. If this recitation (i.e. basis for “level” and for the above/below at 10.3771) is present in the Example 2, further delineation of where this can be found beyond the general fifteen pages that Example 2 spans would be helpful.
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, and 7-21 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 recitation “the C24CPR level is above or below…” lacks proper antecedent basis in the claims.
Does Applicant intend to recite “the C24CRP ratio?”
Further, while Applicant argues on page 11 toward the usage of C24CRP as describing the claimed proportion ratio as claimed, if this is the case, Applicant should remove this term from the parenthesis and instead codify the preceding language to this end by way of a recitation on the order of “…given as the C24CRP ratio.” This is likewise seen with respect to independent claims 13 and 18.
Claims 5 and 9 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 regard to claim 5, the recitation “the analysis…” lacks proper antecedent basis in the claims wherein it appears that Applicant intends to recite “the analyzing…”
With regard to claim 9, the metes and bounds of the claim are indefinitely defined as it is unclear what amount(s) constitute a “therapeutically effective amount” as claimed.
This remains with respect to the added descriptive clause of “…wherein the therapeutically effective amount comprises an amount that restores the 24CPR level to normal levels.
On page 7 of Applicant’s remarks filed October 20th, 2025, Applicant cites page 13 as providing support.
Page 13 does not provide clarity to the metes and bounds of the claim and the amount/range thereof that provides a therapeutically effective amount that comprises an amount that restores the 24CPR level to normal levels.”
The disclosure therein page 13 is highly generalized and prophetic without particulars as to this particular amount or determination thereof.
Further, the specification is without particular discussion and definition to “normal levels” with respect to 24CPR and administering a therapeutically effective amount.
The specification merely provides a general definition to the term in par.[0053] and asserts that one of ordinary skill in the art would determine such an amount.
However, the specification is without teachings (i.e. experimental data, examples, particular principles and guidelines/guideposts) that allow someone of ordinary skill in the art to understand how to determine a therapeutically effective amount.
Response to Arguments
Applicant's arguments filed October 20th, 2025 have been fully considered but they are not persuasive.
With regards to claims 1-20 rejected under 35 USC 101, Applicant traverses the rejection.
Applicant asserts that the claims are not directed to a judicial exception as the claims are drawn to a method which is a statutory category of invention as in Step 1.
This is not disputed in the action re: Step1.
With regard to step 2A (judicial exception, Step 2A, prong 1), Applicant asserts that the claims are not drawn to a ‘natural phenomenon” as the relative level which the method seeks to assess is not naturally occurring.
The ratio provided in the claims (and the particular value 10.3771) is drawn to the biomarker/discovery itself that is given as a natural phenomenon as in the metabolites within the human body and utilized in assessing potential disease/disorder therewith.
The claims remain to provide a judicial exception in setting forth a natural phenomenon.
Further, with respect to Step 2A, Prong 2 (i.e. integration portion), although not particularly argued herein, Examiner reasserts those particular discussions provided above in the body of the action wherein the judicial exception is not integrated into a practical application.
With respect to Step 2B (“significantly more” portion), Applicant asserts that independent claims 1, 13, and 18 have been amended to include that the C24CRP level is above/below around 10.3771.
Examiner asserts that this is not persuasive as satisfying step 2B does not coincide with providing a particular value to the ratio. This is once again merely drawn to the judicial exception itself and providing a particular value to the biomarker discovered. This also remains as a judicial exception itself in which such determination may be accomplished by mental steps in assessing a calculated value.
Further, as discussed above, the recited step of “administering a treatment…” fails to provide a particular treatment/prophylaxis in Step 2A, prong 2 as it is highly generalized (i.e. recites “a treatment…”), amounts to a ubiquitous field-of-use operation to be carried out by all such practitioners with respect to a disease/disorder (i.e. amounts to a general desire to apply a treatment to an ailment as would be expected), and has a nominal/insignificant relationship with respect to the exception (the discovered ratio is not particularly utilized in a manner that informs particular treatment/prophylaxis steps). This is likewise seen with respect to dependent claims 14 and 20 of independent claims 13 and 18, respectively
To this end, Examiner again refers Applicant to the instructive cases of “Endo Pharm” and “Vanda Pharm,” and section 2106.04(d)(2) of the MPEP.
Additionally, and with respect to Mayo vs. Prometheus, Applicant’s discussion that the claims herein “…select or identify patients with diseases or disorders using steps which were not practice in the past and therefore cannot be considered routine…” is not persuasive as the steps of “obtaining” and “analyzing” are highly generalized themselves in what amounts to the respective “obtaining” and “analyzing” (i.e. there are no particular manners of either step and they are recited at their highest level of breadth), and drawn to routine and conventional data gathering steps.
See also Ariosa Diagnostics, Inc. v. Sequenom Inc.788 F.3d 1371, 115 USPQ 2d 1152 (Fed. Cir. 2015) that was drawn to natural phenomenon and deemed ineligible.
And In re Bhagat, Fed. Appx. (Fed. Cir. 2018) CAFC Appeal No. 2016-2525 that was drawn to natural phenomenon and deemed ineligible.
Furthermore, to the above discussion, it is noted that independent claims 13 and 18 do not recite anything additional beyond the judicial exception itself and the extra-solution activity that is the data gathering (“obtaining,” and “analyzing”).
Further, as discussed above, the “determining…10.3771” represents a judicial exception itself in an assessment step that is drawn to a mental step of a user evaluating a result.
See also MPEP 2106.04(a)- Abstract Ideas
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
Lastly, Applicant’s comment that USPTF concluded that there was “adequate evidence not to recommend…” is unpersuasive, not particularly understood as it pertains to the present claim recitations, and not commensurate in scope with the claims.
Applicant further asserts that “unconventional” steps were utilized, however, no such particular step(s) are argued or set forth; and as discussed above, this is not seen to be the case in the claim recitations themselves wherein the claims are directed to a judicial exception for the reasons discussed therein.
Further, the remaining dependent claims 2, 4, 5, 7-12, 14-17, and 19-21are drawn to further mental step evaluations, insignificant extra-solution activity, generalized sample types that are ubiquitous, application of routine and well-known general techniques and amount to “using X” (i.e. various spectrometry, spectroscopy, and chromatography fields [i.e. HPLC/MS] of application and are not assays as would be construed by a set of particular active steps recited to the methodology), and intended usage (i.e. stage 2 hypertension as in new cl. 21) without providing particular, active step(s) the method at-hand that functionally provide for the specific biomarker recited. Further, discussion to the subject (and their genetic variation) and their gender has no particular bearing and correlation within the active steps of the claimed methodology at-hand.
As such, claims 1-2, 4-5, and 7-21 are rejected under 35 USC 101.
With regards to Claims 5 and 9 rejected under 35 USC 112 b/2nd, Applicant traverses the rejection.
Herein, as amended, the claims are maintained rejected.
With regard to claim 5, the recitation “the analysis…” lacks proper antecedent basis in the claims wherein it appears that Applicant intends to recite “the analyzing…”
With regard to claim 9, the metes and bounds of the claim are indefinitely defined as it is unclear what amount(s) constitute a “therapeutically effective amount” as claimed.
This remains with respect to the added descriptive clause of “…wherein the therapeutically effective amount comprises an amount that restores the 24CPR level to normal levels.
On page 7 of Applicant’s remarks filed October 20th, 2025, Applicant cites page 13 as providing support.
Page 13 does not provide clarity to the metes and bounds of the claim and the amount/range thereof that provides a therapeutically effective amount that comprises an amount that restores the 24CPR level to normal levels.”
The disclosure therein page 13 is highly generalized and prophetic without particulars as to this particular amount or determination thereof.
Further, the specification is without particular discussion and definition to “normal levels” with respect to 24CPR and administering a therapeutically effective amount.
The specification merely provides a general definition to the term in par.[0053] and asserts that one of ordinary skill in the art would determine such an amount.
However, the specification is without teachings (i.e. experimental data, examples, particular principles and guidelines/guideposts) that allow someone of ordinary skill in the art to understand how to determine a therapeutically effective amount.
Further, in view of the amendments to the claims, clams 1, 2, 4, 5, and 7-21 are herein rejected under 35 USC 112 b/2nd for the reasons discussed above.
The amended recitation to “the C24CPR level is above or below…” lacks proper antecedent basis in the claims.
Does Applicant intend to recite “the C24CRP ratio?”
Further, while Applicant argues on page 11 toward the usage of C24CRP as describing the claimed proportion ratio as claimed, if this is the case, Applicant should remove this term from the parenthesis and instead codify the preceding language to this end by way of a recitation on the order of “…given as the C24CRP ratio.” This is likewise seen with respect to independent claims 13 and 18.
Further, in view of the amendments to the claims, claims 1, 2, 4, 5, and 7-21 are herein rejected under 35 USC 112 a/1st for the reasons discussed above.
Applicant cites “Example 2” as providing basis for the amended recitation “the C24CPR level is above or below around 10.3771,” however, no such support is found thereat nor within the remainder of the specification.
Examiner notes that “Example 2” spans many pages in going from page 55 to page 80 of the specification, and within, many tables and values are presented in which the above-discussed recitation is not found and including with a numeral search with querying software. If this recitation (i.e. basis for “level” and for the particular above/below at 10.3771) is present in the example, further delineation of where this can be found beyond the general fifteen pages that Example 2 spans would be helpful.
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 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