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 .
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 final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/09/2025 has been entered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Status of Claims
Applicant’s amendment filed 10/09/2025 is acknowledged. Claims 1 and 4-7 have been amended. Claims 1-41 are pending in the instant application and claims 1-21 are the subject of this non-final office action.
All of the amendments and arguments have been reviewed and considered. Any rejections or objections not reiterated herein have been withdrawn in light of amendments to the claims or as discussed in this office action.
Previous Rejection
Status of Prior Rejections/Objections:
The 112(b) rejections of claim(s) 3 and 5-7 and dependent claim(s) is/are withdrawn in view of the amendments to the claims and upon further reconsideration in view of the arguments. The rejection of claim 9 is maintained.
The double patenting rejection over copending Applications 17/576,974, 17/576,976, and 17/576,973 are withdrawn in view of the terminal disclaimers. It is noted that 17/576,973 is the correct application number, which corrects the typographical error in the final rejection listing the application as 17/576,973.
The prior art rejection(s) under 35 USC 103 are withdrawn in view of the amendments.
New Ground(s) of Rejections
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP 2111.
Regarding all claims, independent claim 1 recites “A solid phase LAMP reaction medium comprising…a reaction layer”. MPEP 2111.02 discusses the effect of the preamble. Where the claims are not restricted to a structure that requires structures relevant to a LAMP reaction (e.g., reagents), the claims were interpreted broadly to encompass any solid phase reaction medium with the required structure compatible with such a use.
Para [00178] provides exemplary materials for the reaction layer including glass fiber, nylon, cellulose, polysulfone, polyethersulfone, cellulose acetate, nitrocellulose, and hydrophilic PTFE that are taught as compatible.
Regarding claims 1, 11, and 12, the specification is silent as to a definition of “spreading layer”. As such, it has been interpreted to mean a layer capable of increasing the surface area or otherwise dispersing a sample and/or fluid applied to it, consistent with the specification (e.g., para [00125] and [00166]).
Likewise, the specification is silent as to the definition of “a reaction layer”. As such, has been interpreted to mean a layer capable of allowing or providing means for a reaction to take place. This is consistent with the specification, e.g., para [0020] and [00176].
Further, the specification is silent as to the definition of “a layer”. Therefore, this was interpreted broadly to include laminate compositions of sublayers so long as they fulfil the stated purpose.
Regarding claims 5-7, the specification is silent as to a definition of “a testing area”. Fig. 16 references “Test Reaction Areas” but indicates that there are four depicted, seemingly corresponding to the four light grey strips that appear to be reaction layer strip; further, there is only a single reference to single-sided adhesive so it is not clear if this is a reference to the same embodiment as claimed. Therefore, this was interpreted broadly as any area in which a test, including one or more LAMP reactions as covered by claim 1, was or could be performed, so long as it also had required adhesive sections.
Regarding claim 16, the term “surface area to thickness ratio” lacks a definition or formula in the specification. Therefore, “surface area” has been interpreted to be the sum of all areas of the layer (e.g., approximately 2(length*width + length*height + width*height) for a rectangular prism or 2π(radius^2 +radius*height) for a cylinder/”disc”) and ratio has been interpreted to mean the division of surface areas by thickness (i.e., surface areas / thickness). Further, if there are multiple shapes comprising a layer, the surface areas have been added.
Regarding claims 16-19, the term “about” is defined in the specifications as a “term… used to provide flexibility to a numerical range endpoint by providing that a given value may be ‘a little above’ or ‘a little below’ the endpoint”. As no numeric definitions or further examples for mm or ratios have been provided, the conventional plus or minus 10% has been used for the purposes of applying art.
Claim Rejections - 35 USC § 112(b)
Claim 9 is 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.
Regarding claim 9, the claim recites “reagents selected from the group of: one or more target primers, DNA polymerase, and a re-solubilization agent”. This is an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use.
The Markush grouping of target primers, DNA polymerase, and re-solubilization agent is improper because the alternatives defined by the Markush grouping do not share a “single structural similarity” or a common use. As described in MPEP 2117(II)(A):
A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved.
Primers (oligonucleotides), DNA polymerase (protein/enzyme), and re-solubilization agents (undefined class; example given includes surfactants, para [00166]) would not be readily recognized by the artisan to behave in the same way in the context of the claimed invention such that each member could be substituted for each other with the expectation of the same intended result. Indeed, the artisan would clearly recognize each are distinct classes of reagents and that, for example, both primers and DNA polymerase would be required to carry out a LAMP reaction and thus could not be substituted for one another. An acceptable Markush group in this context would include, for example, a selection of DNA polymerases each suitable for LAMP reaction or a selection of sets of target primers that may each be utilized or a selection of re-solubilization agents that each may serve that purpose.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim 10 depends from claim 9, and is therefore included in this rejection.
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 (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 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.
Claim(s) 1-2, 4, 9, 11-12, 17, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Engelhard (AU 621236 B2; granted 03/05/1992), evidenced by UNESCO (Zooplankton sampling. Paris: UNESCO; 1979).
Regarding claims 1-2, 11-12, and 21, Engelhard teaches:
a reagent matrix (12) attached with its active separating layer (reagent layer) onto a transparent (instant claims 2 and 21; see also pg. 19, line 3) polymer film (11) by means of double-sided adhesive tape (13) (pg. 19, lines 20-25; Fig. 3) [i.e., a substrate; an adhesive layer disposed on the substrate; and a reaction layer disposed on the adhesive layer], wherein
one permeable layer (48), such as a wadding of polymer or glass, paper, or fabric of polymer or glass can be attached to the top side of the reagent matrix (42) (instant claim 11) to improve distribution and adsorption [i.e., a spreading layer disposed on the reaction layer] (pg. 20, lines 3-6)
Engelhard teaches that nylon fabric Nytal and Nytal XXX are preferred permeable layers [i.e., spreading layer] (68) for blood test strips, in particular with several test zones (pg. 24, para 2). Engelhard teaches that the spreading layer has a uniform porosity by teaching Nytal/Nytal XXX as a permeable layer, evidenced by UNESCO. While Engelhard does not explicitly teach that Nytal and derivatives are uniformly porous, it is inherently taught because UNESCO teaches that they are a nylon mesh with what would be understood to be a uniform porosity within normal manufacturing deviation (pg. 173, Table 4; pg. 20, Table 1; see also pg. 154, Specification, Net material).
Alternatively, Engelhard teaches that the reagent matrix is taught to have two porosities (entire document, e.g., pg. 8, para 2), wherein the reagents are applied to the inner layer (pg. 8, para 7). The outer layer is taught to have pore 0.1-0.5 um (pg. 9, para 1), wherein it is depicted as approximately uniform (Fig. 1). Engelhard teaches that polymer fabrics in the reagent layers [i.e., including an upper “spreading” layer] may be transparent (pg. 24, lines 3-6; instant claim 12).
It is noted that Engelhard teaches at least polysulfone and cellulose acetate (pg. 12, para 3), as well as nylon and glass fiber (pg. 26, para 2), for the reaction membrane; these are taught as suitable for the intended reactions of instant invention, i.e., LAMP, in the instant disclosure (see Interpretation).
Regarding claim 4, Engelhard teaches an embodiment in which atmospheric oxygen necessary for a reaction is stored in a free air space (16) (pg. 20, line 34-pg. 21, line 2) in a gap in the adhesive tape (13) (Fig. 3; see also pg. 19, lines 30-31).
Regarding claim 9, Engelhard teaches impregnating the reaction membrane with a surfactant (pg. 41, Example 12), wherein the instant specification teaches that surfactants are re-solubilization agents (para [00166]).
Regarding claim 17, Engelhard teaches a reaction layer of about 0.05-0.1 mm, including on the highly porous inner layer (pg. 8, para 1).
Regarding claim 20, Engelhard teaches a discontinuous reaction layer (Fig. 4b).
For at least these reasons, claims 1-2, 4, 9, 11-12, 17, and 20-21 are anticipated by Engelhard.
Claim Rejections - 35 USC § 103
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhard (AU 621236 B2; granted 03/05/1992) as applied to claims 1 and 9 above, and further in view of Schroff (Schroff S. 100% solids: A compelling solution to the challenges of medical adhesive coating [Internet]. SAE Media Group; 2015 [accessed 2025 Jan 13]. Available from: https://www.medicaldesignbriefs.com/component/content/article/23535-100-solids-a-compelling-solution-to-the-challenges-of-medical-adhesive-coating).
Regarding claim 3, in the device of Engelhard, Engelhard teaches that the detection elements can be attached with either double-sided adhesive tape or with liquid adhesive or hot-melt adhesive (pg. 21, para 2).
Engelhard fails to teach that the adhesive(s) are substantially free of volatile agents.
Schroff rectifies this by teaching that pressure sensitive adhesives (PSAs) [i.e., tape] may outgas volatile organic compound (pg. 2, para 2) due to their use of solvents (pg. 1, para 1) and that even coated PSAs may be a problem for sensitive in vitro diagnostic assay devices, especially those making important healthcare decisions (pg., 2, para 3). Schroff further teaches that 100 percent solid acrylic requires high energy radiation to cure the adhesive but may have lower interference with assay chemistries, has extremely low outgassing [i.e., are substantially free of volatile agents], and non-fluorescing properties (pg. 4). Schroff further teaches that common applications are in vitro diagnostics including lateral flow, microfluidics, PCR, and microtiter plates (pg. 5, para 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the adhesive of Engelhard for the 100% solids adhesive of Schroff, motivated by the desire to reduce any interference with the in vitro diagnostic applications of the device. There would have been a strong expectation of success as both are directed to in vitro diagnostics. Further, such a substitution would have been obvious as an art recognized equivalent for the same purpose under MPEP 2144.06(II).
Claim(s) 5-8 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhard (AU 621236 B2; granted 03/05/1992) as applied to claim 1 above, and further in view of Rolland (US 2014/0295415 A1; published 10/02/2014).
Regarding claims 5-7 and 13, in the device of Engelhard, Engelhard teaches embodiments in which the double-sided tape is contained below the reaction matrix (Fig. 3, Fig. 9); an embodiment with “several test zones” (pg. 24, line 23; Fig. 4b, Fig. 11); and discontinuous adhesive application (e.g., Fig. 2b, Fig. 3, Fig. 4). Engelhard teaches that the reagent matrix may be paper (pg. 23, para 1).
Engelhard fails to teach that the boundaries of sections of a testing area are defined by discontinuous adhesive and to explicitly teach greater than two “sections”.
Rolland teaches an embodiment in which PET film layered with adhesive, with a hole cut out to house the paper test disc, were laminated together to create a chamber [i.e., spacer; instant claim 13] that prevents evaporation during the incubation period while still allowing post-reaction analysis (para [0055]; Fig. 14), thereby defining boundaries of a section using discontinuous adhesive. Rolland teaches that the same plane as the reaction layer (Fig. 14; instant claim 15). Rolland further teaches a set of at least four sections (Fig. 3; Fig. 11, Fig. 21; instant claims 5-7) and teaches plural readouts serviced by respective different dried, color producing reagents, wherein flow paths are defined by liquid impermeable boundaries substantially permeating the thickness of the hydrophilic sheet (para [0214]).
Rolland teaches achieving a detectable result with a single copy of genomic DNA in LAMP analyses in at least some tests (Fig. 15).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the test strips for analyzing biological fluids of Engelhard to improve the compatibility with the LAMP of Rolland, motivated by the low limit of detection taught by Rolland. It thus would have further been obvious to utilize the spacers comprising discontinuous adhesive of Rolland to surround the stacked medium of Engelhard, motivated by the desire to create a boundary that reduces evaporation for uses involving heat, such as LAMP, as taught by Rolland. It likewise would have been obvious to so define at least four sections, at least as an obvious duplication of parts, at least because Rolland teaches at least four testing areas. See MPEP 2144.04)(VI)(b). Thus, it follows that the spacer would be oriented in between the segments of the reaction layer in the combined device (instant claim 15). There would have been a strong and predictable expectation of success as both are concerned with diagnostic tests for biological fluids, including optically observable results, and such represents the application of a known technique to a known device.
Regarding claim 8, in the device of Engelhard and Rolland, Engelhard teaches that reaction membranes can be reagent-free (pg. 8, para 6; see also pg. 36, para 5).
Rolland teaches a subset of sections are negative controls (e.g., para [0164], [0166], [0207]; Fig. 21), but does not explicitly teach that they are free of reagents.
However, in view of both of these teachings, a reagent-free section would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention under MPEP 2144.04(II)(A), motivated by the desire to generate a negative control that controlled for an effect of the sample on the membrane.
Regarding claim 14, in the device of Engelhard and Rolland, Rolland teaches a fluid-impermeable barrier that defines boundaries may be made of polystyrene (claim 15; para [0139-140]).
While Engelhard and Rolland do not explicitly teach a spacer comprising polystyrene, such a material substitution for PET would have been an obvious substitution/addition under MPEP 2144.06 as both were recognized for the same purpose.
Claim(s) 10, 16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engelhard (AU 621236 B2; granted 03/05/1992) as applied to claims 1 and 9 above, and further in view of Seok (Seok Y, et al. A Paper-Based Device for Performing Loop-Mediated Isothermal Amplification with Real-Time Simultaneous Detection of Multiple DNA Targets. Theranostics. 2017 Jun 1;7(8):2220-2230).
Regarding claim 10, in the device of Engelhard, Engelhard teaches a test device for analyzing substances in biological fluids with a matrix comprising an asymmetric pore structure (pg. 1, Field of the invention).
Engelhard fails to teach that the reaction layer comprises reagents sufficient to carry out a LAMP reaction.
Seok rectifies this by teaching a stacked paper device structure (Abstract) comprising an optimized chemical components to enable dry conditions for a LAMP reaction without the need for lyophilization (Abstract) comprising primers, Bst DNA polymerase, and additives to help with drying and/or re-solubilization (Table 1; Fig. 2). Seok further teaches the asymmetric structure of their transfer pad allowed for optimized fluid transfer (pg. 2226, Confirmation of device structure) and concern with pore sizes (pg. 2223, col 1, para 1).
Seok teaches use of a glass fiber pad and that glass fibers have large pores (pg. 2224, para 1).
Seok teaches that LAMP-based multiple diagnostic devices have the potential for real-time analysis with quantitative detection of ~100 copies of genomic DNA, and that such are simple and affordable for point of care testing (Abstract).
Therefore, it would have been obvious to one of skill in the art before the effective filing date of the claimed invention to utilize the optimized chemical components and glass fibers in the large pore reaction layer of Engelhard, motivated by the desire to better optimize the device for LAMP so as to allow for use in real-time analysis with a low level of detection in point of care testing, as taught by Seok. There would have been a strong expectation of success as both are directed to stacked diagnostic devices for biological samples, especially relating to optimization of pore structures to improve analysis, and such represents the application of a known technique to a known device.
Regarding claims 16 and 18, in the device of Engelhard and Seok, Seok teaches that the glass pad was 3 x 3 mm (pg. 2222, Fabrication of paper-based device, para 1).
While this is outside of the 4-12 mm and 4-25 mm, 3 mm is interpreted to be “about” 4 mm. Further, such is a matter of both routine optimization and an aesthetic design change. It would be understood that the dimensions of the reaction layer may be adjusted to suit the number of reaction sections desired and subject to design choices in light of factors such as portability and readability in a point-of-care setting (instant claim 18).
Using the dimensions of Seok’s pad with the 0.1 mm depth of Engelhard’s reaction layer (see the rejection of claim 17), the surface area of an approximately rectangular prism would be approximately:
2(3*3+0.1*3+0.1*3) = 19.2 mm^2
Thus, it follows that the surface area to thickness ratio would be about 192 (instant claim 16).
Regarding claim 19, in the device of Engelhard and Seok, Seok teaches spacing the reaction pads ~4 mm apart (Fig. S4: 2 mm between 5 mm reaction holes, comprising 3 mm squares, which are assumed to be centered).
Response to Arguments
Applicant's arguments filed 10/09/2025 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “lack of a physical barrier between the sample collection layer and ‘wells’”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Contrary to Applicant’s argument to the Office requires a negative limitation, it is noted simply that the claims have been interpreted broadly as required under MPEP 2111. Either an appropriately broad interpretation of “layer” or “disposed on” would have led the artisan to the conclusion reached, not least because Li taught composite layers as discussed previously and the dependent claims reciting material composition specify “comprises”. The independent claim is likewise open ended, aside from the specified limitations, in view of “comprising”. Lacking limitation requiring a narrower interpretation, the limitations were taught.
Nonetheless, new art has been applied to expedite prosecution in view of the additional limitation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMA R HOPPE whose telephone number is (703)756-5550. The examiner can normally be reached Mon - Fri 11:00 am - 7:00 pm.
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/EMMA R HOPPE/Examiner, Art Unit 1683
/NANCY J LEITH/Primary Examiner, Art Unit 1636