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 dated 3/16/26.
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) 3-9, 17-19, 34-39 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Robinson et al (US 2013/0165343 hereafter Robinson) in view of Nikrad et al (WO 2014/105198 A2 hereafter Nikrad).
Robinson discloses methods for detecting biomarkers in a fluid sample including blood [abstract, 0004, 0012]. Among the biomarkers detected by the method include COL1A1, SHBG and CBX7 [Table 1]. The testing can detect dozens of biomarkers [Table 3]. The reference is silent to the specific biomarkers capture reagents. The use of said capture reagents is known in the art as seen in the Nikrad patent.
Nikrad discloses a method of detecting levels of N biomarkers proteins in a samples of bodily fluids such as blood, serum and urine meeting the limitations of claim 19 [0082]. The method includes N is from 5 to 25 biomarkers including SHBG, ACY1 meeting the limitations of claim 7, 8, 17, 18 [0011, 0013]. The method further comprises at least two, three or four slow-off aptamer with an off rate of ≥ 30 minute, meeting the limitations of claim 34-39 [0016]. It would have been obvious to apply these biomarker detection protocols to the method of Robinson in order to detect and diagnose a wider variety of conditions.
With these aspects in mind it would have been obvious to the combine the biomarker testing methods of the prior art in order to detect a broad range of metabolic conditions. It would have been obvious to apply the similar testing of biomarkers in Nikrad to the testing protocol of Robinson as they test similar biomarker proteins and solve the same problem of non-invasive diagnosis. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of stable means of non-invasively diagnosing patients for metabolic disorders.
Response to Arguments
Applicant’s arguments, see Amendment/Remarks, filed 3/16/26, with respect to the rejection(s) of claim(s) 3-11, 17-19, 34-39 and 45 under 35 USC 103(a) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejections.
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
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