DETAILED ACTION
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 .
Acknowledgment of Papers Received: Amendment/Response dated 8/13/25.
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 nonobviousness.
Claim(s) 1-3, 5, 7-10 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Lundin et al (US 2017/0016908 A1 hereafter Lundin) in view of Niwa (Biomarkers discovery for kidney diseases by mass spectrometry, Journal of Chromatography B, 870, 148-153, 2008 hereafter Niwa).
Lundin discloses a diagnosis method for chronic kidney disease comprising analyzing a biological sample such as urine [abstract]. The biological sample is analyzed via mass spectrometry [0055]. The biomarkers are analyzed and compared with a ratio of biomarkers indicating the risk of kidney disease and severity of the disease’s progression, meaning these tests would be repeated over time for trials and treatment procedures [0069-0070, claim 17].
The reference discloses a method for the diagnosis of a chronic kidney disease or glomerulopathy comprising analyzing urine samples with mass spectroscopy and making calculations of the results in order to provide a diagnosis based on the amounts of biomarkers in the sample. The reference however is silent to the specific protein biomarkers of the instant claims. These protein are well known in the art regarding diagnosing conditions as seen in the Niwa study.
Niwa discloses the discovery of different biomarkers and how they relate to different kidney disorders (abstract). The biomarkers are analyzed by mass spectrometry of a biological samples such as urine (abstract). Biomarkers include albumin, alpha-1beta-glycoprotein, zinc alpha2-glycoprotein, alpha-2-HS-glycoprotein, and alpha -1-antitrypsin (3.2). Conditions diagnoses by these methods include Lupus, acute kidney injury and diabetic nephropathy (3.2-3.7). These biomarkers can allow for screening of these conditions (Results). It would have been obvious to apply the analytical methods of Lundin to the biomarkers of Niwa in order to diagnose similar conditions.
Regarding the assigning and determining of probability steps, it is the position of the Examiner that such limitations do not distinguish over the prior art as the prior art accomplishes the same goals. These steps are essentially mental steps that can be accomplished in the mind of the practitioner, and Lundin and Niwa both screen for biomarkers and make assessment of the data, analyzing them against standards and making diagnoses based on these results. Within those diagnostic steps, comparisons to standards are made, and educated inferences are taken buy those of ordinary skill in the art. While not specifically enumerated by the prior art, these probability and assignments and determinations would be a normal part of a diagnosis as multiple conditions might fight the same criteria, but for example diabetic nephropathy might be more likely than lupus nephritis, based on the number and type of biomarkers found in the assay.
With these aspects in mind, It would have been obvious to follow the disclosures of the prior art with an expected result of a method of non-invasive diagnosis. It would have been obvious to apply the assay of Lundin to the biomarkers of Niwa as they both are attempting to diagnosis and monitor similar conditions using the same testing methods. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a method of diagnosing kidney disorders.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-3,5,7-10 and 12 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 5712720616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618