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
Claims 1-7 are examined herein.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Takanashi et al. (IDS; Virol Methods. 2008 Mar;148(1-2):1-8).
Regarding claim 1, Takanashi teaches an immunochromatographic method of testing stool samples for noroviruses (Title and Abstract). The reference teaches that a stool sample is diluted with water and mixed with a reaction buffer comprising 0.5% Tween 20 (pg. 3, col. 1, par. 2). Tween 20 is a water-soluble polymer of instant invention.
Regarding claim 2, Tween 20 is polyoxyethylenesorbitan monolaurate - a compound containing a polyoxyethylene moiety (pg. 3, col. 1, par. 2).
Regarding claim 4, the reaction buffer comprising 0.5% Tween 20 is an extraction liquid for the stool sample (pg. 3, col. 1, par. 2).
Regarding claim 6, the immunochromatographic test strip taught by Takanashi (Fig. 1 and pg. 3, col. 1, par. 2) comprises an anti-norovirus antibody – an immobilized polyclonal antibody applied on the test line (id.), and detects norovirus in the fecal sample (Title).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Takanashi, as applied to claim 2 above, in view of Doerflinger et al. (mSphere. 2016 Oct 12;1(5): e00219-16), and as evidenced by Dow (Triton X-100 Surfactant Technical Data Sheet, pg.1).
The teachings of Takanashi have been set forth above.
Regarding claim 3, Takanashi fails to teach the compound containing a polyoxyethylene moiety is at least one selected from the group consisting of polyoxyethylene distyrenated phenyl ether, polyethylene glycol, polyoxyethylene lauryl ether, and octylphenol ethoxylate.
Regarding claim 3, Doerflinger teaches Development of a Nanobody-Based Lateral Flow Immunoassay for Detection of Human Norovirus (Title). Doerflinger also teaches polyoxyethylene moiety is octylphenol ethoxylate.
Specifically, Doerflinger teaches detection of noroviruses by immunochromatography using a mobile solvent comprising Triton X-100 (pg. 2, last par.). Triton X-100 is also known as octylphenol ethoxylate (Dow, 2026, pg. 1, Chemical Description) meeting the limitation of claim 3 reciting octylphenol ethoxylate.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Takanashi, by employing Triton X-100 surfactant as taught by Doerflinger, as an obvious matter of simple substitution of one known surfactant for another to obtain predictable results.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because both references teach detecting noroviruses in stool samples using immunochromatography, and Tween 20 and Triton X-100 are well-known surfactants, that can be used interchangeably.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Takanashi, as applied to claim 1 above, in view of Daughtridge et al. (WO 2019075487).
The teachings of Takanashi have been set forth above.
Regarding claims 5 and 7, Takanashi fails to teach the water-soluble polymer is contained in a sample drop region of an immunochromatographic test piece and an immunochromatographic test piece for testing a fecal sample, the test piece comprising a water-soluble polymer in a sample drop region.
Regarding claims 5 and 7, Daughtridge teaches a lateral flow immunoassay for monitoring anti-retroviral treatment (Abstract). Daughtridge also teaches a water-soluble polymer is contained in a sample drop region of an immunochromatographic test piece and an immunochromatographic test piece comprising a water-soluble polymer in a sample drop region.
Specifically, Daughtridge teaches that sample pads of immunochromatographic test strips may be treated with surfactants, such as Tween 20 or Triton X-100 (pg. 67, lines 18-23).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Takanashi, by placing a water-soluble polymer in a sample drop region of an immunochromatographic test piece as taught by Daughtridge, in order to promote resolubilization of conjugate-pad constituents, and to block non-specific binding sites in other components of a lateral flow device (Daughtridge pg. 67, lines 20-21). One having ordinary skill in the art would have been motivated to make such a change because lateral flow assays require resolubilization of dried conjugate-pad constituents and benefit from blocking non-specific binding sites in other components of the lateral flow device. The use of such combination would have been desirable to those of ordinary skill in the art for the reasons mentioned above.
One having ordinary skill in the art would have had a reasonable expectation of success in combining the prior art references because both references teach lateral flow assay methods and strips comprising water-soluble polymer Tween 20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alexander Volkov whose telephone number is (571) 272-1899. The examiner can normally be reached M-F 9:00AM-5:00PM (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy Nguyen can be reached on (571) 272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER ALEXANDROVIC VOLKOV/Examiner, Art Unit 1677
/REBECCA M GIERE/Primary Examiner, Art Unit 1677
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