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 Claims
Applicant's amendment filed 03/30/2026 is acknowledged. Claims 1 and 9 have been amended. Claims 22-41 remain withdrawn. Claims 1-41 are pending in the instant application and claims 1-21 are the subject of this 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 Any rejections or objections not reiterated herein have been withdrawn in light of amendments to the claims or as discussed in this office action.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Previous Rejection
Status of Prior Rejections/Objections:
The 112(b) rejections to claim(s) 9-10 are maintained and further clarified.
The prior art rejection(s) under 35 USC 102 directed to claim(s) 1-2, 4-9, 11-12, 17, and 20-22 as being anticipated by Engelhard is withdrawn in view of the amendments.
The prior art rejection(s) under 35 USC 103 directed to the following are withdrawn in view of the claim amendments:
Claim 3 over Engelhard in view of Schroff;
Claims 5-8 and 13-15 over Engelhard in view of Rolland; and
Claims 10, 16, and 18-19 over Engelhard in view of Seok.
New Ground(s) of Rejections
The new ground(s) of rejections were necessitated by applicant’s amendment of the claims.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Information Disclosure Statement
The information disclosure statement filed 08/18/2026 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Applicant is requested to submit a translation of the Taiwanese search reports and/or a list of the documents cited therein and the US applications the TW Applications correspond to.
Claim Rejections - 35 USC § 112(b)
Claims 9-10 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.
Regarding claim 9, the amended claim recites “at least one reagent selected from the group of: one or more target primers; or, DNA polymerase; or, 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, rather than the group of any of the three together.
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 § 103
Claim(s) 1-2, 4, 9-12, 17, and 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner (US 10968493 B1; effectively filed 07/24/2020; as cited in the IDS dated 10/09/2025) in view of Kopelman (US 20080041136 A1; published 02/21/2008) and Engelhard (AU 621236 B2; granted 03/05/1992), evidenced by UNESCO (Zooplankton sampling. Paris: UNESCO; 1979).
Regarding claims 1 and 9, Tanner teaches a solid phase LAMP reaction medium comprising:
a substrate; and
a lyophilized LAMP reagent mixture disposed on top of the substrate (col 5, para 5; col 25, para 5; col 17, j; col 3, para 2).
Tanner teaches a reagent mixture for lyophilization in colorimetric LAMP (Example 5) comprising:
Bst [a DNA polymerase] and a detergent [i.e., a re-solubilization agent] (Example 5; instant claim 9),
wherein the RT is recited to be glycerol-free [i.e., lacking a hygroscopic agent] and no ammonium compound is recited (Example 5).
Regarding claim 10, Tanner teaches that this composition is sufficient to perform a LAMP (Example 5
Tanner teaches that a desirable format for measuring a color change is a strip test such as those routinely used for pregnancy or the inline StepA test or equivalent, and that its pH dependent colorimetric LAMP is quick, easy, reliable, and suitable for scale up in molecular diagnosis of at least viruses (col 22, para 2).
Tanner teaches use with clinical samples such as blood and urine (col 4, para 1).
Tanner teaches various “salts” and optimizing the composition by varying the salt concentrations/choice (col 43, para 2-3; Fig. 15; col 17, m).
While Tanner teaches the lyophilization reagent mixture without explicit ammonium compounds, it does not explicitly teach avoiding ammonium compounds (e.g., “salts”).
Tanner fails to explicitly teach:
the structure of such test trips, including an adhesive layer, a reaction layer containing the reagent mixture on the adhesive layer, a spreading layer with uniform or gradated porosity on the reaction layer;
transparency and material of the substrate and spreading layer (claims 2, 11, 12, and 21);
a thickness of the reaction layer (claim 17); and
a discontinuous reaction layer (claim 20).
Regarding claim 1, Kopelman teaches phenol red as an indicator dye in combination with a substrate where the indicator dye changes color according to the gaseous ammonia concentration (claim 10). Kopelman teaches that ammonia has a basic and nucleophilic nature and can react with a phenolic moiety to induce a color change (para [0037-38]). Kopelman also teaches preventing ammonium ions from contacting a sensor membrane (claim 14) on which the indicator dye is immobilized (claim 1).
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 (emphasis added), 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.
Regarding claim 4, Engelhard teaches an embodiment with gaps in the adhesive tape (pg. 20, line 34-pg. 21, line 2; 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). Engelhard teaches that the structure depends on the polymer and preparation method (pg. para 1).
Regarding claim 20, Engelhard teaches a discontinuous reaction layer (Fig. 4b) with several reagent matrices (pg. 20, para 1).
Engelhard teaches that test strips that contain reagents in a matrix of paper or plastic and in which the sample is applied directly to the matrix are extremely important for quick and simple analysis of individual samples (pg. 1A, Background of the Invention, para 1). Engelhard teaches that its test strips allow separation of red blood cells without additional aids and to be used in urinalysis (pg. 6, Summary of the Invention, para 1), wherein detection in chromogenic detection systems may be performed without interference from erythrocytes and the detection reaction can be observed at the membrane surface (pg. 9, para 4).
Engelhard teaches that transparent plastic material permits readings from the bottom of the device (pg. 22, para 1). Engelhard teaches that it is possible to use only transparent polymer fabrics (pg. 24, para 1).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have avoided ammonium compounds in the undisclosed components of the master mix of LAMP reagents of the reaction layer of Tanner, motivated by the desire to avoid reactions/color change with the pH sensing dye, including phenol red, as taught by Kopelman, where omission of an element and its function is obvious if the function is not desired, as discussed in MPEP 2144.04(II)(A).
Additionally, it would have been obvious to the POSITA before the EFD of the claimed invention to have avoided further hygroscopic agents in the LAMP reagent mixture, motivated by the teachings of Tanner to use a glycerol-free enzyme where glycerol is understood to be a hygroscopic agent (see instant para [00114]), no other strongly hygroscopic agents are taught, and to lyophilize the reaction mixture, wherein the function of water absorption [hygroscopic nature] would be contrary to the ability of the contents to be freeze dried, i.e., lyophilized, and avoiding additional such agents would be obvious as further discussed in MPEP 2144.04(II)(A).
Further, it would have been obvious to the POSITA before the EFD of the claimed invention to improve the LAMP reaction medium of Tanner by using the strip test layer structure and materials of Engelhard, motivated by the desire to allow for detection without the interference from blood cells/pigments, as taught by Engelhard.
In using the strip test of Engelhard, it would have been obvious to the POSITA before the EFD of the claimed invention to have utilized the materials, transparency, and reaction layer thickness taught by Engelhard, motivated by the desire to improve distribution and adsorption with the spreading layer materials and to improve the easy of monitoring the reaction and to omit a function that was not desired (i.e., opacity), wherein each is taught or suggested by Engelhard; the particular choice of materials would be obvious species among the genus of materials for each layer presented by Engelhard; and wherein the particular thickness represents an optimizable variable dependent at least on the choice of material/preparation method (see, e.g., pg. 8, para 1).
In adapting the strip test of Engelhard, it would have been obvious to the POSITA before the EFD of the claimed invention to have utilized the discontinuous reaction layer embodiments of Engelhard at least because making separable and/or duplicating parts is obvious, as discussed in MPEP 2144.04(V)(C) and 2144.04(VI)(B). Discontinuous disposal of adhesive tape would be obvious for the same reasons.
There would have been a strong expectation of success as Tanner, Engelhard, and Kopelman are each directed to colorimetric tests on substrates, where such represents the application of a known product/technique to a known product for predictable improvement.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner (US 10968493 B1; effectively filed 07/24/2020; as cited in the IDS dated 10/09/2025) in view of Kopelman (US 20080041136 A1; published 02/21/2008) and Engelhard (AU 621236 B2; granted 03/05/1992), evidenced by UNESCO (Zooplankton sampling. Paris: UNESCO; 1979), as applied to claims 1-2, 4, 9-12, 17, and 20-21 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 combined product, 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).
Tanner, Kopelman, and Engelhard fail to explicitly 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 the combined product 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 Tanner (US 10968493 B1; effectively filed 07/24/2020; as cited in the IDS dated 10/09/2025) in view of Kopelman (US 20080041136 A1; published 02/21/2008) and Engelhard (AU 621236 B2; granted 03/05/1992), evidenced by UNESCO (Zooplankton sampling. Paris: UNESCO; 1979), as applied to claims 1-2, 4, 9-12, 17, and 20-21 above, and further in view of Rolland (US 2014/0295415 A1; published 10/02/2014).
Regarding claims 5-7 and 13, in the combined product, Tanner teaches a paper-based spot test with at least four “sections” (Fig. 12).
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).
Regarding claim 8, in the combined device, Engelhard teaches that reaction membranes can be reagent-free (pg. 8, para 6; see also pg. 36, para 5).
Tanner, Kopelman, and Engelhard fail to teach:
that the boundaries of sections of a testing area are defined by discontinuous adhesive and a spacer (claims 5-7 and 13);
sections are free of reagents (claim 8); and
materials of a spacer (claim 14).
Regarding claims 5-7 and 13, 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).
Rolland teaches multiplexing/simultaneously detecting a plurality of analytes and making and selling for a low cost (para [0029])
Regarding claim 8, Rolland teaches a subset of sections are negative controls (e.g., para [0164], [0166], [0207]; Fig. 21).
Regarding claim 14, Rolland teaches a fluid-impermeable barrier that defines boundaries may be made of polystyrene (claim 15; para [0139-140]).
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 of the combined product to improve the compatibility with the LAMP by utilizing spacers comprising discontinuous adhesive in the same plane as the reaction layer (instant claim 15)/between reaction layer segments, as taught by 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 define at least four sections in this manner, at least as an obvious duplication of parts, at least because Rolland teaches at least four testing areas and that multiplexing enables simultaneously detecting a plurality of analytes while maintaining low cost. See MPEP 2144.04(VI)(B), discussing duplication of parts.
It also would have been obvious to the POSITA before the EFD of the claimed invention to have included a reagent-free section among such sections, motivated by the desire to generate a negative control, as suggested by Rolland, that controlled for an effect of the sample on the membrane. See MPEP 2144.04(II)(A), discussing eliminating an element if its function is not desired.
Further, 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 to the POSITA before the EFD under MPEP 2144.06 as both were recognized for the same purpose, given the teachings of Rolland.
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.
Claim(s) 16 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tanner (US 10968493 B1; effectively filed 07/24/2020; as cited in the IDS dated 10/09/2025) in view of Kopelman (US 20080041136 A1; published 02/21/2008) and Engelhard (AU 621236 B2; granted 03/05/1992), evidenced by UNESCO (Zooplankton sampling. Paris: UNESCO; 1979), as applied to claims 1-2, 4, 9-12, 17, and 20-21 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).
Tanner, Engelhard, and Kopelman fail to teach dimensions for the reaction lay or spacing between segments.
Regarding claims 16 and 18, Seok teaches that a glass pad [reaction layer] 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.
Regarding claim 19, 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).
Seok teaches a stacked paper device structure (Abstract) comprising an optimized chemical components to enable dry conditions for a LAMP reaction (Abstract). Seok teaches a concern with fluid transfer (pg. 2226, Confirmation of device structure) and pore sizes (pg. 2223, col 1, para 1) and use of asymmetric membrane (entire document, e.g., pg. 2221, Materials, para 1).
Therefore, it would have been obvious to the artisan before the effective filing date of the claimed invention to have utilized the dimensions of Seok in the combined device, as such represents a combination of prior art elements to yield predictable results. Further, the dimensions of the multiplex combined device (i.e., reaction layer and spacing between) represent a matter of routine optimization (e.g., for efficient fluid distribution across a pad based on the choice of material, as suggested by Seok) and/or a matter of aesthetics (e.g., choice of round in Rolland vs. square reaction layers in Engelhard and Seok), wherein even in a narrower reading. It would be obvious to the POSITA before the EFD 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, in the combined product, it would be obvious to the POSITA before the EFD of the claimed invention that the surface area to thickness ratio could be about 192 mm^2/mm (instant claim 16), where the choice of such dimensions would be obvious for the same reasons as above.
Response to Arguments
Applicant's arguments filed 03/30/2026 have been fully considered but they are not persuasive.
Regarding the 112(b) rejection, Applicant traverses the rejection as indefinite and notes the amendment.
The rejection is maintained and further clarified. As has been further reiterated in Ex parte Chowdhury, recently designated as informative, the members of a Markush group may be proper if each performs as similar function. However, as has been noted, the artisan would not recognize that each member of the Markush group of claim 9 performs a similar function. Accordingly, the Markush grouping remains improper.
Regarding the 103 rejections, on pg. 10-11, Applicant argues that Engelhard is not drawn to the same field of endeavor because LAMP does not require asymmetry and the application Engelhard has in mind is blood separation. Applicant further argues that Rolland is not analogous in process to the teachings and claims because Rolland requires their device to be moved to conduct the various steps of the LAMP reaction, in contrast to the device of Applicant. Applicant argues that Seok requires the use of wax printing and asymmetric membranes for distributing the sample to reaction pads, which does not scale easily compared to the claimed spacers of the Applicant and Applicant does not require asymmetry. Applicant further notes that glass fiber is not optimal for obtaining vibrant colorimetric response and that cellulose is much better when using phenol red as the reporter.
The examiner respectfully disagrees that each of Engelhard, Rolland, and Seok are not analogous to the invention. In response to applicant's arguments directed to nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
In the case of Engelhard, Engelhard is directed to colorimetric detection of analytes on solid-phase mediums for at least the biological samples of blood and urine and minimizing pre-processing of samples (e.g., pg. 6, Summary of the Invention; pg. 19, para 1-2; and further as cited above in the 103 rejection). The claimed invention is also directed to colorimetric detection of analytes on solid-phase mediums (in particular, nucleic acids via LAMP), including for samples that may be blood and urine (e.g., instant para [00111] and [00199]; Examples). Further, Engelhard is “reasonably pertinent” in that it is concerned with producing a read-made test strip where the color reaction and its evaluation take place on opposite site of the product from where the sample is applied (see, e.g., pg. 19, para 1), which is the same problem that the configuration claimed appears to be addressing (e.g., e.g., instant Fig. 16: “sample application side” and “read side”).
In the case of Rolland, respectfully, the claims under examination at present are directed to the product not the process. Rolland is at least in the same field of endeavor as it, too, is directed at molecular diagnostic devices for detecting a polynucleotide analyte in a sample from a patient, particularly in a point of care setting (Abstract). Rolland utilizes colorimetric assessment of amplicons in test zones (e.g., para [0016] and [0020]), wherein the amplification may be LAMP (e.g., para [0118], Example 2).
Regarding Seok, likewise, is directed to paper-based devices for performing LAMP for the detection of nucleic acid targets (Title) and would be at least in the same field of endeavor.
Where the Applicant arguments may be interpreted to assert that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “no asymmetry”; a level of scalability; and a vibrancy of the colorimetric response) 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).
In the instant case, the asymmetric structure of Engelhard may be interpreted as two layers, as mapped in the 103 rejections, where the outer layer may be interpreted to be a spreading layer with uniform porosity and the inner layer may be interpreted to be the reaction layer containing the LAMP reagent mixture. Further, it is noted that the claims encompass a spreading layer with gradated porosity where the BRI encompasses an asymmetric porosity (e.g., the transfer/spreading layer of Seok).
Further, regarding the scalability/wax printing, Seok is not being relied upon for the wax printing; the claims requiring spacers have been rejected over the combination with Rolland and a level of scalability has not been claimed.
Regarding the vibrancy/glass fiber, while it is noted that Applicant prefers cellulosic embodiments for vibrancy, it is noted that Applicant has also disclosed the suitability of glass fiber for the reaction segments (e.g., para [00168]) and the instant claims do not require a particular material for the reaction layer.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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
