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 .
Status of the claims
The response filed 10/03/25 is acknowledged and has been entered. Claims 1-3 and 5-10 are pending and under examination.
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 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Oved et al (WO 2013/117746) (submitted in the IDS filed 03/02/23) in view of Daniels et al (US 2002/0004246).
Oved et al discloses a method of ruling in bacterial infection in a subject (e.g. para’s 00013, 00015) and discloses the method can comprise measuring TRAIL and CRP polypeptides in a sample from a subject (e.g. para’s 00013, 00015, 00264-00265). Oved et al discloses that that the method can also include the measurement of IP10 (e.g. para’s 00017-00018, 00264-00265). Oved et al discloses that once a bacterial infection is ruled in that a treatment regime such as an antibiotic can be administered (e.g. para’s 00015-00020,00270-00274). Oved et al discloses that TRAIL is below a threshold in bacterial infections (e.g. para 0013) and CRP is higher (e.g. 0282). Oved et al discloses that the measurement can be by immunoassay wherein antibodies that bind the polypeptides are utilized (e.g. page 9, para 00030 and pages 58-59). Oved et al discloses that the immunoassay format for the detection can be by sandwich immunoassay (non-competitive binding assay) (e.g. para 0348). Oved et al discloses that the sample can be blood, serum (fraction of blood) or plasma (fraction of blood) (e.g. page 47, para 000226). Oved et al also discloses that the effectiveness of treatment can be monitored (e.g. para 00271). Thus, teaching the treatment regimen was administered.
Oved et al differs from the instant invention in failing to teach using a lateral flow immunoassay device containing a lateral flow test strip which comprises first antibody against said TRAIL and a second antibody against said CRP and an additional antibody for IP10.
Daniels et al teaches a lateral flow immunoassay device for detecting and quantifying one or more analytes of interest in a test sample (e.g. abstract, para’s 0108-0122). Daniels et al discloses that the device comprises multiple labeled reagents which specifically bind the analytes (e.g. 0114, 0207, 0215). Daniels et al discloses that the device comprises capture (test band) and control regions having reagents that bind the analyte (e.g. 0116-0119). Daniels et al discloses that the detection format can be a non-competitive 0122). Daniels et al discloses that the labeled reagents and capture reagents can be antibodies (e.g. Figures and para’s 0142-0151). Daniels et al teaches that the capture reagents are at distinct locations along the test strip and that multiple detection reagents are used which bind to a corresponding analyte when detecting multiple analytes (e.g. para 0207). Daniels et al discloses that this provides for an assay that are is inexpensive to produce, easy to use, and capable of giving quantitative results for multiple analytes (e.g. para 0015).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate a lateral flow immunoassay device such as taught by Daniels et al with the antibodies for TRAIL and CRP and the measurement of TRAIL and CRP in the method of Oved et al because Oved et al is generic with respect to the immunoassays and specifically teaches that sandwich assays (non-competitive assay) an be used for the detection and Daniels et al shows that the device allows for determining the amount of multiple analytes in a sample and that this provides for an assay that are is inexpensive to produce, easy to use, and capable of giving quantitative results for multiple analytes. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a lateral flow immunoassay device such as taught by Daniels et al with the antibodies for TRAIL and CRP and the measurement of TRAIL and CRP in the method of Oved et al.
It would have also been obvious to one of ordinary skill in the art to incorporate the antibodies for IP10 and the measurement of IP10 in the method of Oved et al because Oved et al is generic with respect to the immunoassays and Daniels et al shows that the device allows for determining the amount of multiple analytes in a fluid sample and provides for an assay that are is inexpensive to produce, easy to use, and capable of giving quantitative results for multiple analytes. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a lateral flow immunoassay device such as taught by Daniels et al with the antibodies for TRAIL and CRP and the measurement of TRAIL and CRP in the method of Oved et al.
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Oved et al and Daniels et al and further in view of Goldstein et al (US 2012/0083711).
See above for the teachings of Oved et al., and Daniels et al.,
Oved et al., and Daniels et al., differ from the instant invention in failing to teach an additional lateral flow test strip comprising an antibody against IP10.
Goldstein et al teaches that it is known and conventional in the art that reagents can be placed in the same lateral flow strip or can be placed in multiple parallel strips in a single device (e.g. page 9, para. 0089).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to incorporate the antibodies for IP10 and the measurement of IP10 in a separate parallel test strip in the modified method and device of Oved et al because Goldstein et al shows that multiple test strips can be placed parallel in a single test device. Further, the placement of antibody against IP10 on the same or a different test strip would have been an obvious design choice, since Applicant has not disclosed this specific alignment of reagents solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with the labeled IP10 on the same of different test strip as long as the measurement of IP10 is performed.
Response to Arguments
Applicant’s arguments filed October 3, 2025 and the Declaration of Hans Boehringer under 37 C.F.R. 1.132 have been fully considered but they are not persuasive.
Applicant argues that the declaration corroborates the Applicant’s position that the selection of a non-competitive assay format in the claimed invention represents a non-obvious and counterintuitive design choice. Specifically, for an analyte such as TRAIL, whose lower concentration is associated with a positive diagnosis (i.e., bacterial infection), the standard and expected design choice is to use a competitive format—so that a positive clinical result corresponds with a visible signal. This aligns with widespread clinical and lay user expectations and reduces the risk of misinterpretation.
By contrast, the claimed invention employs a non-competitive format wherein a decrease or absence of signal signifies a positive diagnosis. This approach runs contrary to standard practice and user-interface logic in the design of LFAs. The declarant confirms that, in their professional experience, this design choice would not be intuitive or considered routine. Rather, such a selection would likely be discouraged absent the specific insights of the inventors.
These arguments and the Declaration of Boehringer is insufficient and not found persuasive because the declaration is based solely on the opinion of Boehringer without any factual evidence being provided. Further, Oved et al is teaching the detection of the same biomarkers as currently recited and for the same reason as currently recited (ruling bacterial infection). Oved et al specifically teaches that TRAIL is below a threshold in bacterial infections and CRP is higher (same as currently recited). Oved et al even teaches that the assay format can be a sandwich immunoassay (non-competitive assay). Thus, one of ordinary skill in the art is clearly motivated to the use of a sandwich assay for detecting the TRAIL and CRP because Oved et al specifically teaches that this format can be used. Also, one of ordinary skill in the art must consider all embodiments of a disclosure and it is well settled that a reference must be evaluated for all disclosures not just its preferred embodiments. In re Mills, 470 F. 2d 649, 176 USPQ 196 (CCPA 1972).
Applicant argues that Daniels et al., while disclosing multiplexing and alternative assay formats, does not suggest using a non-competitive format for low-abundance analytes like TRAIL where the absence of signal conveys clinical meaning. Nor does Daniels address the specific diagnostic challenge of ruling in a bacterial infection using this signaling logic. The combination of Oved and Daniels fails to disclose or suggest the full scope of the claimed invention, nor does it provide any motivation to adopt such an approach. As such, the rejection relies on impermissible hindsight.
This argument is not found persuasive because Daniels et al specifically teaches that sandwich assays are known and conventional on test strips and that while test strips may employ any one of a variety of assay schemes, including sandwich assay (both direct and indirect) and competitive reaction assays, all have in common the element of a detectable label that permits identification of an analyte of interest when present in an experimental sample (e.g. para 0005) and teaches that the analyte can be any analyte of interest that is a specific substance or component that is being detected and/or measured by the test strip assay of the present invention. Further, it is noted that the instant claims recite “when the amount of TRAIL is below a first predetermined amount (e.g. threshold such as taught in Oved which also specifically teaches the TRAIL is below a threshold) (NOTE: there is nothing in the claims directed to absence of signal). Further, as stated above although one may prefer a competitive assay one must also consider the sandwich assay because both Oved et al and Daniels et al teach the use of such assay and there is no factual evidence that the sandwich assay does not work for the recited biomarkers on a test strip and Oved or Daniels does not teach away from the use of sandwich assays. Thus, one of ordinary skill in the art would have a reasonable expectation of success incorporating a lateral flow immunoassay device such as taught by Daniels et al with the antibodies for TRAIL and CRP in in the method of Oved et al.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 GARY W COUNTS whose telephone number is (571)272-0817. The examiner can normally be reached M-F 7:00-4:00.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678