The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 8-10-2026 has been entered.
Claims 1-7 and 15-24 are currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 8-10-2026 has been considered. Initialed copies are attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
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.
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.
Claims 1-7 and 15-24 are rejected under 35 U.S.C. 103 as being unpatentable over Filali-Ansary et al. (Therap. Drug Mon, Vol. 38 No. 4, pages 471-482 – IDS filed on 12-29-2022) and Meesters et al. (Bioanalysis Vol. 3 No. 20, pages 2357-2364 – IDS filed on 8-10-2026).
Filali-Ansary et al. disclose the use of dried blood spot methodology in combination with liquid chromatography and tandem mass spectrometry to measure the teriflunomide concentrations in human blood (see page 472, left column). Filali-Ansary et al. further disclose that said teriflunomide is a treatment for relapsing-remitting multiple sclerosis; that due to its long half-life it’s concentration in blood should be monitored; and that when used in pregnant women a concentration of ≤ 0.02 mcg/mL (i.e. the non-teratogenic level) should be achieved (see page 471, right column). Finally, Filali-Ansary et al. disclose that the internal standard used is blood sample is [2H4]-teriflunomide (see page 472, left column) and the blood samples can be obtained via finger-prick (see page 475, right column). With regard to claims 4 and 5, while Filali-Ansary et al. do not utilize the terminology “peak area ratio” with regard to the measurement of teriflunomide et al., the do disclose that the threshold for fetal toxicity (i.e. being a teratogen) is a concentration of ≤ 0.02 mcg/mL and that calculations of the curve’s parameters are based on the ratio of the peak areas of teriflunomide/IS versus the concentration of teriflunomide and that teriflunomide concentrations for samples were calculated from the curve’s equation obtained by means of linear regression. Consequently, Filali et al. anticipates all the limitations of the rejected claims.
Filali-Ansary et al. differs from the instant invention in that they don’t disclose the adding the internal standard to the filter paper prior to addition of the sample (i.e. pretreating filter paper).
Meesters et al. disclose multiple methods of using internal standards in dried spot analysis generally (see abstract) and the pretreatment of the DBS paper prior to sample spotting (see page 2359).
The KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that Filali-Ansary et al. demonstrates the use of internal standards in DBS methods and the pretreatment of the filters is well established in the art (as evidenced by Meesters et al.), the pretreatment of the DBS filters with the internal standard in the methods of Filali-Ansary et al. is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met.
Conclusion
No claim is allowed.
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/ROBERT A ZEMAN/Primary Examiner, Art Unit 1645 August 17, 2026
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