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 .
Receipt is acknowledged of IDS filed on 10/05/2022, 03/10/2025, and 02/24/2026.
Claims 17-27 have been added.
Claims 1, 5-6, 8-12 and 16-27 are pending.
Claims 2-4, 7, and 13-15 are cancelled.
Claims 1, 5, 6, and 16 are amended.
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 2/10/2026 is acknowledged.
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, 5-6, 8-12 and 16-27 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.
Regarding claims 1, 9, 12, 16, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claims 1, 5, 6, 10, and 18-27, the “variants” does not meet the written description provision of 35 USC § 112, first paragraph, due to lacking chemical structural information for what they are and chemical structures are highly variant and encompass a myriad of possibilities. The specification provides insufficient written description to support the genus of biomarker variants encompassed by the claim, since there is no description of the structural relationship of these variants provided in the specification and Applicant has not provided a description as to how the base molecule may be changed while remaining a variants.
Regarding claim 11, it is unclear if the second “the biomarker” is in reference to the biomarker from the sample or the reference biomarker. For compact prosecution purposes, it is interpreted to mean the reference biomarker.
The dependent claims fall therewith.
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.
Claims 1, 5, 6, 8-10, 12, 16-19 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ARTHUR (US 2014/0038203 A1).
Regarding claim 1, ARTHUR teaches a method for determining an increased risk of developing acute kidney injury (AKI) in a subject (claim 1 and claim 5). The method comprises the steps of:
Measuring a protein, which reads on biomarker, from a sample from said subject (claim 1), proteins/biomarkers such as Complement factor D and Insulin-like growth factor-binding protein 1 are examined (table 1A), which reads on determining in a sample obtained from the subject the amount of at least two biomarkers including both Complement factor D and Insulin-like growth factor-binding protein 1.
The measurement is compared to a reference sample (claim 1), which reads on comparing the amount of said at least two biomarkers one biomarker with a reference amount for said at least two biomarkers one biomarker, wherein the reference amount is the amount of the respective biomarker in healthy subjects, such as subjects who are not at risk of developing AKI and/or who do not have AKI, and
If an increased risk is determined, then therapy can be administered (claim 3), which reads on changing a therapy plan of the subject when a risk of AKI is predicted or when an early diagnosis of AKI is made.
Note, with regard to claim 1, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).), this is in reference to “wherein an increased amount of Complement factor D and Insulin-like growth factor-binding protein 1, or isoforms, fragments or variants thereof, compared to the reference amount indicates that the subject has AKI or is at risk of developing AKI”. Furthermore, ARTHUR teaches that the sample relative to a reference level indicates that the subject has an increased risk of developing the nephropathy or kidney disease (claim 1).
Regarding claim 5-6 and 10, ARTHUR teaches further proteins/biomarkers can be tested, such as haptoglobin (table 1A), which is a protein biomarker.
Regarding claim 8, ARTHUR teaches the sample is a urine sample (claim 1).
Regarding claim 9, ARTHUR teaches that samples were taken from subjects prior to receiving renal replacement therapy (page 17, paragraph 0155), which reads on planned medical intervention.
Regarding claim 12, ARTHUR teaches that the measuring step comprises performing an EILSA assay (claim 22).
Regarding claim 16, ARTHUR teaches that if an increased risk is determined, therapeutic drugs can be given to the patient (Page 2, paragraph 0013), which reads on administration of drugs alleviating go9r reversing AKA effects.
Regarding claim 17, ARTHUR teaches samples were taken from patients with Aki after cardiac surgery who did or did not require dialysis (page 4, paragraph 0019).
Regarding claim 18, 19, and 22, ARTHUR teaches further proteins/biomarkers can be tested, such as Chitinase-3-like protein 1, haptoglobin, (table 1A).
Claim Rejections - 35 USC § 103
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 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 nonobviousness.
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, 5, 6, 8-12, 16-19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over ARTHUR (US 2014/0038203 A1) in view of VARGHESE (Identification of Diagnostic Urinary Biomarkers for Acute Kidney Injury. American Federation for Medical Research. 2010.).
ARTHUR teaches Applicant’s invention as discussed above.
ARTHUR does not teach that the biomarkers have a sequence identity with reference biomarker.
Regarding claim 11, VARGHESE teaches identifying proteins for diagnosing AKI (abstract). To identify the protein biomarkers in the sample, protein sequencing was done (page 617, paragraph 2), which matches the sequences for proper identification (figure 4). This allowed for accurate analysis and identification (abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate having the biomarkers have a sequence identity with reference biomarker. The person of ordinary skill in the art would have been motivated to make those modifications, because this allows for accurate identification, and reasonably would have expected success because the references are in the same field of endeavor, such as identifying biomarkers for AKI.
The reference does not specifically teach the percentage of sequence identity as claimed by the Applicant. The percentage of sequence identity is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of the ordinary skill to determine the optimal percentage of sequence identity in order to best achieve desired results, such as a high enough percentage match to confirm the biomarker. The higher the match the more accurate the identification is. Thus, absent of some demonstration of unexpected results from the claimed parameters, this optimization of the percentage of sequence identity would have been obvious at the time of Applicant’s invention.
Claims 1, 5, 6, 8-12, and 16-27 are rejected under 35 U.S.C. 103 as being unpatentable over ARTHUR (US 2014/0038203 A1) and VARGHESE (Identification of Diagnostic Urinary Biomarkers for Acute Kidney Injury. American Federation for Medical Research. 2010.) in view of KRISHNAPPA (Acute Kidney Injury in Hematopoietic Stem Cell Transplantation: A Review. Internatinal Journal of Nephrology. 2016.) and WONG (A Multibiomarker-Based Model for Estimating the Risk of Septic Acute Kidney Injury. Crit Care Med. 2015.).
ARTHUR and VARGHESE teach Applicant’s invention as discussed above.
ARTHUR and VARGHESE do not teach analyzing for elafin and myeloblastin.
Regarding claim 20, 23, 25, and 27, KRISHNAPPA teaches method of determining and reducing risk of AKI (abstract) and that increased urinary elafin levels were found to be associated with the development of AKI (page 9, paragraph 6).
Regarding claim 21, 24, 26, and 27, WONG teaches measuring various biomarkers to determine the development of AKI (abstract), such as proteinase 3 (page 4, paragraph 1), also known as myeloblastin.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate elafin and proteinase 3/myeloblastin as biomarkers analyzed. The person of ordinary skill in the art would have been motivated to make those modifications, because high levels of these biomarkers are associated with the development of AKI, and reasonably would have expected success because the references are in the same field of endeavor, such as biomarkers for AKI.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA L. MEJIAS whose telephone number is (703)756-5666. The examiner can normally be reached M-F.
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
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