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. 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. Claim s 1-6, 11, 15 , 18, 26, 28, 38-42, and 44-49 are rejected under 35 U.S.C. 101 because the claimed invention , both individually and as an ordered combination, is directed to an abstract idea without significantly more. The claim(s) , including all of independent claims 1 , 3, and 40 recite(s) “ comparing …”, “wherein a lower level… indicates..., “wherein an equivalent or higher level… indicates …” that are drawn to mental steps/assessments that amount to an abstract idea of characterizing one’s renal decline , and likewise as in claim 40 to “determining the appropriate risk…” ( Step 2A, Prong 1) . This judicial exception is not integrated into a practical application because the claims do not provide a practical application thereto . The “detecting a level of at least one protective protein in a sample…” is drawn to mere data gathering, and that is recited at a high level of generality that is drawn to insignificant extra-solution activity. It is further noted that the listing of the prospective proteins likewise does not provide integration of a practical application to the abstract idea, but merely speaks back to the general data gathering by way of “detecting…” in which such recitations to the prospective protein(s) to be detected does not transform the “detecting” to provide a practical application . This is likewise seen in independent claim 40 that provides further the obtaining of the sample and combining of data which are drawn to extra-solution activity and data gathering (as well as reading toward an abstract idea itself in “combining data” reading on mathematical concepts), respectively ( Step 2A, Prong 2B ) . See also MPEP 2106.05(g). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements provided beyond the general data gathering step and the abstract idea(s) given by the ‘comparing’ and ‘indicating’ clauses , and wherein the provision to “obtaining a biological sample from the human subject” is drawn to extra-solution acvity ( Step 2B ). This also remains to be seen in the dependent claims that do not provide integration of the abstract idea by way of a practical application, and do not provide significantly more than the abstract idea. Claim 2 is drawn to further extra-solution activity in the “detecting” that is drawn to mere data gathering, and discussion to prospective proteins whose data is to be gathered does not provide integration of the abstract idea into a practical application, and does not provide significantly more than the abstract idea itself. Claim 4, similar to that of claim 2, is drawn to further extra-solution activity in the “detecting” that is drawn to mere data gathering, and discussion to prospective proteins whose data is to be gathered does not provide integration of the abstract idea into a practical application, and does not provide significantly more than the abstract idea itself. Claim 5, the recitation itself is drawn to a further qualification and a part of the abstract idea itself in the initial “comparing…” step, and further, wherein provision to a human subject as a part of the claim presents another piece of non-statutory subject matter. This is likewise seen in cl s . 41 , 44, 45 . With regard to claim s 6 , 46 , and as it pertains to Step 2A, Prong 2 toward a “practical application of the abstract idea,” the recitation to providing a general “therapy” to a subject that is identified as having a risk of renal decline does not represent a practical application to the abstract idea as providing a therapy to a subject that has been indicated of an ailment is not unique or particular to the abstract idea at-hand and instead is a ubiquitous application all practitioners provide to a patient with an ailment. Such recitation amounts to a general “apply it” with respect to the abstract idea and adds insignificant extra solution activity as therapy administered to a subject is a ubiquitous action that is not unique to the abstract idea at-hand. 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) ); With regard to claim 11, the recitation itself is drawn to another abstract idea in that of a mental assessment/characterization given, and wherein the recitation itself is drawn to insignificant extra-solution activity as the recitation is descriptive to a human subject, and wherein a claim relying upon a human subject is drawn to non-statutory subject matter under 35 USC 101 as seen below. This is likewise seen as in cl s . 42 , 47 . With regard to claim s 15 , 48 , the recitation does not provide significantly more than the abstract idea as it remains drawn to the data gathering aspect of the “detecting” step as in independent claim 1, and wherein the recited “using…” is drawn to provisions of well-known and conventional analytical chemistry techniques known in the art, and wherein their “using” is provided in a highly generalized fashion that amounts to general discussion of the analytical technique or analytical field of interest at-large. This is likewise seen with respect to the choices of “immunoassay” and “mass spectrometry” in which the typified categories thereof are well-known and conventional in the art. Furthermore, this discussion itself is also merely representative of two of the possible six “usages” provided (immunoassay, mass spectrometry, liquid chromatography fractionation, SOMAscan, mesoscale platform, electrochemiluminescence detection). The recitation of claim 46 amounts to extra-solution activity as it provides discussion to general prophylaxis that is a ubiquitous action to be taken by a practitioner when treating a malady of a patient. With regard to claim s 18, 42, 49, provision to the sample relates back to the insignificant extra-solution activity of detecting protein levels of a sample. Claims 26, 28, 38, and 39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claim amounts to a “use claim,” which does not fall within one of the four categories of patent eligible subject matter. "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101 . In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101 : "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid." See MPEP 2173.05 (q). Further, as in claims 5, 11, 26, 28, 38-42, 44, and 47 : Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim s 5, 11, 26, 28, 38-42, 44 , and 47 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claims 5, 11, 26, 28, 38-42, 44, and 47 are directed to or encompassing a human organism . 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 appl icant regards as his invention. Claim s 1-6, 11, 15 , 18 , 26, 28, 38-42, and 44-49 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 claimed methodology as in both of independent claims 1 and 3 are indefinitely defined as the recitation “level” is not clearly understood. Applicant’s disclosure at par.[0042] of Applicant’s pre-grant publication US 20240192227 provides that “level” or “amount” of a biomarker refers to the measurable quantity of a biomarker, e.g. protein level of a biomarker , wherein such definition is both non-definitive as it relates to an exemplary discussion of “e.g. protein level of a biomarker,” and the term “level” is further defined by the term itself int hat of “protein level” that remains to indeterminately define what particular measurement/quantity/concentration provides for the recited “level” in the claims. Par.[0120] speaks to comparison to known baseline concentrations of proteins that are known or measured, but this speaks to the comparison and not to what is being detected in the initial assessment of “a level of at least one protective protein…” Par.[0122] generally and prophetically provides that the “level” may be determined by any suitable method , which does not provide definitive discussion as to the metes and bounds of “level.” Clarification is required. Claims 1-6, 11, 15 , 18, 19, 23, 24, 26, 28, 38-42, and 44-49 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 claims are indefinitely defined as the term “protective protein” (and likewise to “agonist of a protective protein” such as in cl. 26 and elsewhere in the claims) is not a term of art, and the specification does not provide a clear and definitive definition thereof. The specification generally provides this term (abstract, pars.[0007-0011,0014,0021,0025,0027] of Applicant’s pre-grant publication US 2024/0192227) and discloses exemplary choices for the protective protein (see above passages and elsewhere in the specification). Exemplary discussion to “protective protein” does not provide a definition, as it is merely exemplary. Applicant is invited to claim those proteins disclosed herein in lieu of the indefinitely defined terminology of “protective protein.” This is likewise seen with “agonist of a protective protein,” as it relies upon the indefinitely defined “protective protein.” Examiner notes exemplary discussion to agonists as in pars.[0159-0162,0165,0173,0176,0179,0182]. Applicant is invited to claim those particular protective proteins and their concordantly-disclosed agonists. Claim 15 contains the trademark/trade name ‘ SOMAscan ’ (Examiner notes that recitation herein to “SOMAsca m ” is treated as an inadvertent typographical error) . Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph. See Ex parte Simpson , 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe determination of the level of the protein and, accordingly, the identification/description is indefinite. Applicant is invited to claim the particular “usage” as in the active step(s) that amount to such usage of “SOMAscan” to determine the level of the protein. Further, as in claim 15 , the metes and bounds of the claimed method and its positively provided, active step(s) that provide for determining the level of the protective protein are indefinitely defined as the claim utilizes the vague descriptor of “using” such various, and generalized analytical techniques and analytical fields at-large. What active step(s) are carried out to the method concordant with each of the six alternative choices “used” herein? It is further noted that “mesoscale platform” merely speaks to a general field of technology and also to the physical system itself involved therein, and also is ordinarily understood to be drawn to an immunoassay and electrochemiluminescence technology, which element are already recited in the claim. This, in and of itself, presents another issue of indefiniteness as the claim provides a range within a range, in which mesoscale platform represents a species-type recitation to that immunoassay and electrochemiluminescence genus-type recitations previously provided. Claims 23 and 24 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 recitation of claim 23 sets forth a “test panel,” however th e only item recited is that of the protein array of 19. By this, it is unclear what further element(s) provide for the “test panel” aspect as this is otherwise a redundant claim to that of the protein array of claim 19. Are there particular substances provided to each spot of the array to assess their concentration/specific binding thereat? Are there several different blood/urine samples utilized for particular antigen or antibody presence found therein? Clarification is required. This is similarly seen with respect to claim 24, in which the claim amounts to a redundant recitation to that of the test panel of claim 23, which is herein drawn to a redundant recitation of a protein array as in cl. 19. What added elements make this a kit to the test panel of claim 23? Does Applicant intend to claim the particular, reagents, enzymes, test cards, sample collectors, etc . that make-up a kit including the prior test panel/protein array? Clarification is required. Claims 26, 28, 38, and 39 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 claims amount to a “ use claim ,” wherein their metes and bounds as to the active process(es) sought to obtain a particular application are indefinitely defined. Applicant’s intentions are further not understood as the claim itself amounts to the general concept of prophylaxis. The preamble makes mention treating or preventing renal decline, however, the body of the claim is to general prophylaxis without any particular assessment(s) concordant with or correlated to “renal decline.” Clarification is required. The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 38 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 38 provides the choice of a nucleic acid and the nucleic acid is a vector, wherein claim 38 presents many alternative choices wherein it is not necessitated that one choose nucleic acid . It appears that Applicant intends to provide a prior dependent claim to that of claim 28 with a recitation to the order of “…of claim 28, wherein the at least one protective protein is a nucleic acid.” And subsequent thereto, provide further definition to that nucleic acid as in present claim 38. However , it is noted that “nucleic acid” does not appear to be utilized in the grouping of choices and it appears Applicant intends this recitation to be with respect to a “nucleic acid encoding [x].” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claim Rejections - 35 USC § 102 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. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claim(s) 19, 23, and 24 , as best understood herein, is/are rejected under 35 U.S.C. 102 a1 as being anticipated by Sanchez et al. (EP 23330471A1), hereafter Sanchez . With regard to claims 19, 23, and 24, Sanchez discloses a protein array for identifying or monitoring progressive renal decline of a human subject, the protein array comprising antibodies or antigen-binding fragments thereof specific for human FGF20, ANGPT1, PF4, CCL5 (provided “RANTES” herein, as its alternative naming) (pars.[0022,0046-0049], for example). Further, as in cl. 19, the recitation to “for identifying or monitoring progressive decline of a human subject” is drawn to a functional recitation wherein Sanchez provides a commensurately structured protein array, as discussed above, and is thus fully capable thereof. With regards to claims 23 and 24, as the claims do not provide further structure to the base protein array of claim 19, the protein array of Sanchez is equivocally constituted as a “test panel” and “kit or assay device” in as much as claimed and required herein. With regard to claim 38, Boldog discloses the nucleic acid is a vector (par.[0244]). Claim(s) 26 and 28, and 38 , as best understood herein, is/are rejected under 35 U.S.C. 102 a1 as being anticipated by Boldog et al. (US 2004/0006015), hereafter Boldog . With regards to claims 26 and 28, Boldog discloses a method of treating or preventing renal decline in a human subject comprising administering to a subject an effective amount of at least one protective protein and/or at least one agonist of a protective protein, wherein the at least one protective protein comprises FGF20 (pars.[0637,0663], for example), and wherein recitation “of treating or preventing renal decline…” is drawn to an intended use provided in the preamble of the claim not attributed particular patentable weight, and wherein Boldog discloses the commensurately, actively claimed method step of “administering to a subject…” wherein it is said that the methodology Boldog is also fully capable of treating or preventing renal decline in as much as recited and required herein. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NEIL N TURK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8914 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 930-630 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Charles Capozzi can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-3638 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NEIL N TURK/ Primary Examiner, Art Unit 1798