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 .
Application Status
Claims 1-20, filed 9/15/2025, with claims 4, 5 and 18 withdrawn, and Group I, claims 1-3, 6-17, 19 and 20, elected. The restriction was traversed, however the restriction is maintained because the system of claims 4, 5, and 18 is a different product than the authentication assay that could be used for a different purpose than just in combination with the assay.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/29/22, 6/20/23, 10/15/24,3/21/25, 12/22/25 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where noted:
The IDS of 6/20/23, NPL reference 1, has no author listed. For NPL reference 15, the journal name, to be proper, for has been amended. The IDS of 10/15/24 NPL 1, Berk has been lined through because it was already presented on the 3/29/2022 IDS.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 3, 6, 7, 8-14, 15-17, 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is indefinite in the recitation in the preamble “authentication assay, using…”. Since the claim is directed to a product (the assay), while the intent could be that the assay uses the taggants, “using” could also be interpreted to involve a method of use of taggants. It is highly advised to select a word other than “using” that includes the taggants as components of a product, and that cannot be construed/misconstrued or generate ambiguity to suggest method steps in addition to a product being claimed. New matter must be avoided.
Claim 1 is indefinite and confusing in the recitation of, ‘incubation of the substrate with sample results in binding of the DNA taggant to the at least one reporter oligonucleotide, thereby initiating toehold mediated strand displacement reaction that exchanges the complementary strand of the at least one reporter oligonucleotide for the at least one taggant, including the fluorophore molecule, and excitation of the fluorophore molecule attached to taggant causes the fluorophore to emit light, thereby resulting in a pattern of emitted light at assay locations’. This portion of the claim is now inclusive of the method of use of the product, where the sample was collected with a taggant, the sample taggant will be bound to the reporter, and for this to happen, an incubation of the sample and substrate together must be conducted, so that during this incubation that must take place, a strand displacement reaction will occur. Then, the excitation of the fluorophore causes light emission, and this produces a pattern of light. The mixing of product components, with steps that construed as method steps, if not clarified, presents a singular claim inclusive of product and method. It is suggested that the claim be rewritten to consist clearly of only the product, if that is what is intended.
Claims 2, 3, 6, 7 depend from claim 1, and are indefinite in the recitation for the same reason.
Claim 3 is indefinite in the recitation of the decoy taggant “having a third region with a unique sequence…” but where the first and second regions are not addressed and could be: not present, the same as the non-decoy taggant, or something different.
Claim 8 is indefinite and confusing in the recitation of ‘ A method for manufacturing ‘ combined with what appear to be method steps that do not relate to manufacture, but rather to intended use: “incubation of the substrate with a sample of the authenticity label results in binding the taggant to the at least one reporter oligonucleotide thereby initiating a toehold mediated DNA strand replacement reaction that exchanges the complementary strand of the at least one reporter oligonucleotide for the at least one taggant including the fluorophore molecule and excitation of the fluorophore molecule attached to the taggant causes the fluorophore molecule to emit light, thereby resulting in a pattern of emitted light at one or more assay locations” is not construed to be a “method of manufacture”.
Claims 9-14 depend from claim 8, and are indefinite in the recitation for the same reason.
Claim 11 has the same issue and recites the method of claim 8 (a method of manufacture) further comprising: exciting the fluorophore molecule with a light emitting device (a use claim) and capturing the pattern of emitted light with an optical reader (also a use).
Claim 12 depends from claim 11, and is indefinite in the recitation for the same reason.
Claim 13 has the same issue and recites the method of claim 8 (a method of manufacture) further comprising, including the label in a coating applied to a surface of the product where at least application to a surface is a use.
Claim 14 has a similar issue and recites the method of claim 8, further comprising when the product is a liquid, adding the authenticity label to the product, which is not a method of manufacture of the assay, but a use.
Claim 15 has a similar issue as claim 1, regarding the use of “an authentication assay using…” and “incubation of the substrate with the sample results in binding, and a strand displacement reaction that displaces a strand and exposure of the substrate to light configured to excite fluorophores produces a pattern of light …”
Claims 16-18, 20 depend from claim 15, and are indefinite in the recitation for the same reason.
Claim 20, the label is added to the product is a use of an assay.
Claim interpretation
In evaluating the patentability of the claims presented in this application, the claims will be given their broadest reasonable interpretation, in view of the specification, and as set forth at MPEP§ 2111.
The term “assay” can present ambiguity in claims. Per the remarks of 9/15/2025 the authentication assay is a product. It is noted that a claim to a product may reference the process of use so long as the claim is directed to the product and not the process of use. Otherwise, a claim with both product and method steps of use of product is indefinite.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Berk (ACS Appl Mater Interfaces April 14 2021, cited on 3/29/2022 IDS).
Re: claim 1, An authentication assay using DNA taggants:
Berk disclosed an authentication assay using taggants (Fig 1):
claim1, a substrate with plurality of separated assay locations with reporters bound via anchor region
Berk depicts plurality of separated assay locations (Fig 1b, c) and anchored reporters (Fig 1a) and discussed (in Fig 1 legend).
claim 1, a sample of an authenticity label collected from a product (Fig 1C),
Here the interpretation being employed is: an authenticity label is considered part of the assay, and the sample collection is directed to the authenticity label, which is part of the product, therefore this has not been rejected under 112(b).
Berk depicts a sample of an authenticity label (applied and/or) collected from a product in Fig 1C.
claim 1, each reporter oligonucleotide bound to each assay location, has three regions,
the first region a single stranded toehold common to reporters, the second region includes universal sequence bound to each assay location, the third region includes unique sequence different for each reporter, second and third regions of reporter are pre-hybridized with complementary strand, complementary to reporter(s)
Berk disclosed reporter oligonucleotides with poly T tail, single stranded 6 bp toehold and a unique computationally-generated sequence ((Fig 1A, Fig legend line 2, Pg 19477 right col, top para; Pg 19483 right col, para 2). Berk depicts reporter complex of fluorophore and quencher oligonucleotides that are complementary (akin to second/third regions per above), and they are hybridized, bound their length, except at the toehold that is single stranded (Fig 1A).
Berk did not disclose the universal sequence. It would have been prima facie obvious to one or ordinary skill in the art to also have had the generated sequence contain a common sequence (i.e. second region) in addition to the unique sequence. The motivation to do in Berk would come from wanting to efficiently recognize a pool of taggants all belonging to one test, particularly for when a sample had not produced the anticipated result, or if intermingling of taggants occurred prior to testing because for example multiple taggants for different tests were accidentally combined during collection, since this was a field kit and collection (Pg 19438 right col final para) and included multiple swabs for different surfaces (Fig 6, Fig 6 legend). In Berk, 32 assays were generated, some of which ended up accidentally mishandled and as a result, discarded (Pg 19479, right col, para 1). To eliminate complications from potential mishandling of multiple field collected samples to be field-tested, a common sequence (and complement) in reporters/taggants for individual tests would ensure samples intended for (two) different tests and accidentally mixed or combined, could not result in binding on the wrong test, particularly if unique generated sequences were used more than once for separate tests (but only once for a given test).
claim 1, the sample includes at least one taggant, with sequence complementarity to reporter oligonucleotide first, second regions and with complementarity to third (toehold) region of at least one reporter oligonucleotide bound to assay location, at least one taggant including flurophore molecule configured to light upon excitation,
Berk depicts strand displacement with sample taggant (Fig 1A, bottom two images) thus taggant is complementary to reporter sequence, and here is complementarity to toehold of reporter (Fig 1A, 2nd, 3rd images, orange nucleotide hybridization marks, relative to black in second image are toehold). The reporter has a poly T tail that anchors the reporter complex onto the nitrocellulose substrate (Fig 1 legend, Fig 1B,C, Abstract).
Berk depicts fluorophore, at the end of the reporter complex (Fig 1A). Since the taggant and reporter are hybridized together, the taggant is construed to include a flurophore which emits when excited (Fig 1, Pg 19482 kit “blue” flashlight to excite fluorescence (shown in Fig 6).
incubation of the substrate with sample results in binding and initiating toehold mediated strand displacement reaction that exchanges the complementary strand of a reporter for the taggant including fluorescent molecule and
excitation of the fluorophore molecule attached to taggant causes the fluorophore to emit light, thereby resulting in a pattern of emitted light at assay locations
Berk depicts incubation of substrate and sample (Fig 1C), binding and toehold mediated strand displacement (Fig 1A,B). Berk does exchange complementary strand of reporter in strand displacement reaction that exchanges complementary strand of reporter for taggant (Fig 1A, second to fourth image) including fluorescent molecule, and excitation of fluorophore causes emitted light (flashlight to excite fluorescence, Pg 19482, left col final para; taggant-reporter bound light Fig 1b, image of lighted test ticket, Fig 1C). Excitation of the fluorophore molecule causes emitted light (taggant/reporter binding fig 1 b recites “matching pairs light up” and image depicts this, as does fig 1c test ticket with lit up reads). Fig 6 depicts fluorescence visible upon viewing with blue LED light.
Conclusion
All claims rejected.
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/LISA HORTH/Examiner, Art Unit 1681
/GARY BENZION/Supervisory Patent Examiner, Art Unit 1681