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 .
Response to Amendment
The Amendment filed 01/06/2026 has been entered. Claims 1-12 remain pending in the application. Applicant’s amendments to the claims have overcome each and every 112(b) rejections previously set forth in the Non-Final Office Action mailed 10/06/2025.
Claim Objections
Claim 1 is objected to because of the following informalities: In lines 7-8, it is suggested to recite “the first major surface disposed on the second…” as “the first major surface of the analyte binding layer disposed on the second…”. Appropriate correction is required.
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 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, 4-5, and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 20090111169 A1) in view of Perbost et al. (US 6171797 B1).
Regarding claim 1, Kim teaches an article (Fig. 1), comprising:
a flexible carrier film (Fig. 1 and paragraph [0045], flexible substrate 100) with a first major surface (top surface of substrate 100) and a second major surface (bottom surface of substrate 100), wherein a first major surface of the flexible carrier film comprises an array of structures extending away therefrom (Fig. 1, array of pads 120 extending from the top surface of substrate 100), wherein at least a portion of the structures comprise:
an inorganic layer (Fig. 1, layer of active pads 120; paragraph [0041] teaches the active pads are made of silicon oxide) with a first major surface (bottom surface of active pads 120) and a second major surface (top surface of active pads 120), wherein the first major surface of the inorganic layer is on the flexible carrier film (bottom surface of active pads 120 is on substrate 100),
an analyte binding layer (Fig. 1, layer of probes 160) with a first major surface (interpreted as the bottom surface of the probes 160) and a second major surface (interpreted as the top surface of the probes 160), the first major surface disposed on the second major surface of the inorganic layer (Fig. 1 shows the bottom surface of the probes 160 are on the top surface of active pads 120 via elements 140, 142), wherein the analyte binding layer (probes 160) is bonded to the inorganic layer (active pads 120) via a network of linkers (linkers 140), and wherein the second major surface of the analyte binding layer (Fig. 1, interpreted as the top surface of probe 160) comprises at least one functional group selected to bind with a biochemical analyte (paragraphs [0047]-[0048] teach the probes 160 are probes is for a target of biological sample to be analyzed, therefore inherently comprises at least one functional group to bind to a target biological sample, i.e. biochemical analyte); and
recessed features interspersed with the structures (Fig. 1, teaches gaps or recesses between pads 120, i.e. structures), each recessed feature having a floor (Fig. 1, interpreted as the bottom floor 100 of the recesses between pads 120) and walls extending away from the floor (Fig. 1 interpreted as the walls of the pads 120 that extends away from the floor 100 to form the gaps or recesses between pads 120), wherein at least a portion of the recessed features are free of the inorganic layer and the analyte binding layer (Fig. 1 teaches the gap or recesses between pads 120 are free of the pads 120 and probes 160), and
further wherein the second major surface of the inorganic layer (Fig. 1, top surface of active pads 120) and the floors of the recessed features (Fig. 1, interpreted as the bottom floor 100 of the gap or recesses between pads 120) comprise etched surfaces (interpreted as a product-by-process limitation, see MPEP 2113, wherein even though product-by-process claims are limited by and defined by the process, i.e. etched, determination of patentability is based on the product itself, and if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process; since Kim teaches the structures of the claimed second major surface of the inorganic layer and the floors of the recessed features, Kim teaches all of the limitations of the claimed surfaces; paragraphs [0083]-[0086] teaches etching to form the pads on the substrates, therefore, the second major surface of the inorganic layer and floors of the recessed features are etched surfaces).
Kim fails to teach the network of linking groups as a network of hydrocarbon linking groups.
Perbost teaches arrays of distinct polymers covalently bonded to the surface of a substrate, the arrays are used for analyte detection (abstract). Perbost teaches the substrate includes flexible substrates (column 3, lines 55-57). Perbost teaches a reactive moiety is bound to a substrate via a linking group (column 5, lines 15-26), wherein suitable linkers include hydrocarbon chains (column 6, lines 25-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the linkers of Kim to incorporate the teachings hydrocarbon linkers of Perbost (column 5, lines 15-26; column 6, lines 25-29) to provide: the network of linking groups as a network of hydrocarbon linking groups. Doing so would have a reasonable expectation of successfully binding a reactive moiety, e.g. a probe, to a flexible substrate as taught by Perbost (column 5, lines 15-26; column 6, lines 25-29).
Regarding claim 4, modified Kim fails to teach wherein the inorganic layer (Fig. 1, layer of active pads 120; paragraph [0041] teaches the active pads are made of silicon oxide) has a thickness of less than 100 nm.
Kim teaches the inorganic layer (Fig. 1, layer of active pads 120; paragraph [0041] teaches the active pads are made of silicon oxide) has a thickness of about 100-125 nm (paragraph [0039]).
Since Kim teaches the inorganic layer with a range of thickness (paragraph [0039]) that is merely close to the claimed range of less than 100 nm, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the thickness of the inorganic layer of modified Kim to provide: the inorganic layer has a thickness of less than 100 nm. See MPEP 2144.05 (I). I.e., a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (Titanium Metals Corp. of Americav.Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985)).
Regarding claim 5, Kim further teaches wherein the inorganic layer comprises an oxide of silicon, titanium or aluminum (Fig. 1, layer of active pads 120; paragraph [0041] teaches the active pads are made of silicon oxide).
Regarding claim 8, modified Kim fails to teach wherein the hydrocarbon linking group is at least one methylene unit long, and wherein the hydrocarbon linking group and can be linear, cyclic, branched, or aromatic and can optionally contain heteroatoms.
Perbost teaches arrays of distinct polymers covalently bonded to the surface of a substrate, the arrays are used for analyte detection (abstract). Perbost teaches the substrate includes flexible substrates (column 3, lines 55-57). Perbost teaches a reactive moiety is bound to a substrate via a linking group (column 5, lines 15-26), wherein suitable linkers include hydrocarbon chains, usually of 2 to 12 atoms, which structures may be linear or branched and include one or more features, e.g. annular structures, such as phenyl moieties, heteroatoms, e.g. N, S, O and the like (column 6, lines 25-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrocarbon linking group of modified Kim to incorporate the teachings hydrocarbon linkers that include hydrocarbon chains that can be linear or branched of Perbost (column 5, lines 15-26; column 6, lines 25-29) to provide: wherein the hydrocarbon linking group is at least one methylene unit long, and wherein the hydrocarbon linking group and can be linear, cyclic, branched, or aromatic and can optionally contain heteroatoms. Doing so would have a reasonable expectation of successfully binding a reactive moiety, e.g. a probe, to a flexible substrate as taught by Perbost (column 5, lines 15-26; column 6, lines 25-29).
Regarding claim 9, modified Kim fails to teach wherein the hydrocarbon linking group is derived from a condensation of a functional silane onto the inorganic layer, wherein the functional silane comprises functional groups chosen from epoxides, oxiranes, aziridines, isocyanates, alcohols, thiols, amines, chloromethylbenzyl, bromomethylbenzyl, iodomethylbenzyl, alkyl halides, vinyl, carbonyls such as aldehydes and ketones, carboxylic acids, esters, azides, sulfates, phosphates, alkenes, alkynes, (meth)acrylates, (meth)acrylamides, norbornenes, diazonium salts, hydrazines, hydrazones, oximes, halogens, hydroxyls, tetrazoles, tetrazines, benzophenones, aryl azides, halogenated aryl azides, diazos, azos, and mixtures and combinations thereof.
Kim teaches coupling of probes includes silane linkers (paragraph [0088]),
Perbost teaches arrays of distinct polymers covalently bonded to the surface of a substrate, the arrays are used for analyte detection (abstract). Perbost teaches the substrate includes flexible substrates (column 3, lines 55-57). Perbost teaches a reactive moiety is bound to a substrate via a linking group (column 5, lines 15-26), wherein suitable linkers include hydrocarbon chains (column 6, lines 25-29). Perbost teaches a substrate or solid support may be prepared with conventional silanization procedures using silanes (column 6, lines 30-49). Perbost teaches attaching a probe to a substrate includes preparing a surface with a linker reacted with a complementary functional group, such as an amine, hydroxyl, hydrazide, or carboxyl group (column 9, lines 21-39). Perbost teaches reactive groups include halogens (column 5, lines 38-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrocarbon linking group of modified Kim to incorporate the teachings of silane linkers of Kim (paragraph [0088]) and the teachings of conventional silanization procedures using silanes, and linkers with functional groups such as amine, hydroxyl, hydrazide, carboxyl group, or halogens of Perbost (column 5, lines 15-26; column 5, lines 38-47; column 6, lines 25-29; column 6, lines 30-49; column 9, lines 21-39) to provide: wherein the hydrocarbon linking group is derived from a condensation of a functional silane onto the inorganic layer, wherein the functional silane comprises functional groups chosen from epoxides, oxiranes, aziridines, isocyanates, alcohols, thiols, amines, chloromethylbenzyl, bromomethylbenzyl, iodomethylbenzyl, alkyl halides, vinyl, carbonyls such as aldehydes and ketones, carboxylic acids, esters, azides, sulfates, phosphates, alkenes, alkynes, (meth)acrylates, (meth)acrylamides, norbornenes, diazonium salts, hydrazines, hydrazones, oximes, halogens, hydroxyls, tetrazoles, tetrazines, benzophenones, aryl azides, halogenated aryl azides, diazos, azos, and mixtures and combinations thereof. Doing so would have a reasonable expectation of successfully binding a reactive moiety, e.g. a probe, to a flexible substrate as taught by Perbost (column 5, lines 15-26; column 6, lines 25-29).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. silane linkers with functional groups such as amines and carboxylic acids) by known methods with no change in their respective functions (i.e. attachment of the analyte binding layer to a surface), and the combinations yielded nothing more than predictable results (i.e. providing the linking group with silane linkers with functional groups such as amines and carboxylic acids would yield nothing more than the obvious and predictable result of enabling linking or binding of the analyte binding layer to the article). See MPEP 2143(A).
Regarding claim 10, Kim further teaches wherein the structures comprise posts (Figs. 1-2 show active pads 120 as posts) with a diameter of 10 nm to 10,000 nm (paragraph [0044] teaches the length of the active pads is 200 nm, therefore, the diameter is between 10-10000nm; note that the BRI of “posts” includes rectangular shaped posts and the claim does not specify the posts are circular).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Perbost as applied to claim 1 above, and further in view of Krishnamoorthy et al. (US 20220291172 A1; effectively filed 08/19/2019).
Regarding claim 2, modified Kim fails to teach wherein the flexible carrier film further comprises an anti-biofouling layer.
Krishnamoorthy teaches a biosensor for sensing an biomolecule, the biosensor comprising nanoscale regions having affinity for the biomolecule and a passivation region (abstract; Figs. 14-15). Krishnamoorthy teaches the biosensor comprises a passivation layer (Figs. 14-15, element 26) between nanodomes (22). Krishnamoorthy teaches the nanoscale regions are isolated from one another by the passivated region in such a way that adsorption of the analyte on the interface is confined to the nanoscale regions (paragraphs [0014],[0059]). Krishnamoorthy teaches the passivated region may comprise an anti-fouling layer; for instance, the passivated region could comprise a layer of protein-resistant polyethylene glycol moieties (paragraph [0025]). Krishnamoorthy teaches the nanopatterned sensor interfaces provides for increases in sensitivity (paragraph [0072]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible carrier film of modified Kim to incorporate the teachings of an anti-biofouling layer between sensing regions of a biosensor of Krishnamoorthy (Figs. 14-15; paragraphs [0014],[0025],[0059]) to provide: wherein the flexible carrier film further comprises an anti-biofouling layer. Doing so would have a reasonable expectation of successfully improving adsorption of target analytes at desired regions and therefore improve sensitivity of the overall article.
Regarding claim 3, modified Kim fails to teach wherein the anti-biofouling layer comprises a material chosen from the group consisting of fluoropolymers, non-aromatic hydrocarbon polymers, cyclic olefin polymers, cyclic olefin copolymers, cyclic block copolymers, silicones, metals, a methyl terminated layer, a noble metal and mixtures and combinations thereof.
Krishnamoorthy teaches a biosensor for sensing an biomolecule, the biosensor comprising nanoscale regions having affinity for the biomolecule and a passivation region (abstract; Figs. 14-15). Krishnamoorthy teaches the biosensor comprises a passivation layer (Figs. 14-15, element 26) between nanodomes (22). Krishnamoorthy teaches the nanoscale regions are isolated from one another by the passivated region in such a way that adsorption of the analyte on the interface is confined to the nanoscale regions (paragraphs [0014],[0059]). Krishnamoorthy teaches the passivated region may comprise an anti-fouling layer; for instance, the passivated region could comprise a layer of protein-resistant polyethylene glycol moieties (paragraph [0025]). Krishnamoorthy teaches the nanopatterned sensor interfaces provides for increases in sensitivity (paragraph [0072]). Krishnamoorthy teaches the passivation layer is a methoxypolyethylene glycol thiol (SH-PEG-CH.sub.3) layer (paragraph [0094]), i.e. a methyl terminated layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the flexible carrier film of modified Kim to incorporate the teachings of an anti-biofouling layer between sensing regions of a biosensor of Krishnamoorthy (Figs. 14-15; paragraphs [0014],[0025],[0059]) and a methyl terminated layer of methoxypolyethylene glycol thiol of Krishnamoorthy (paragraph [0094]) to provide: wherein the anti-biofouling layer comprises a methyl terminated layer. Doing so would have a reasonable expectation of successfully improving adsorption of target analytes at desired regions and therefore improve sensitivity of the overall article.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Perbost as applied to claim 1 above, and further in view of Ofir et al. (US 20090264317 A1).
Regarding claim 6, while Kim teaches coupling of probes includes silane linkers (paragraph [0088]), and probes can include a polymer (paragraph [0048]), modified Kim fails to teach wherein the analyte binding layer is chosen from the group consisting of reactive silane, a functionalizable hydrogel, a functionalizable polymer, and mixtures and combinations thereof.
Ofir teaches a functionalized patternable material on a substrate that reacts with a chemical moiety (abstract). Ofir teaches functionalized patterned surfaces are employed in manufacture of articles for analytical devices, sensors, and sensing arrays (paragraph [0065]). Ofir teaches a functionalized patterned surface can comprise geometric features such as squares or rods (paragraph [0054]). Ofir teaches rapid and facile replication of three-dimensional patterns wherein selected features of a pattern can be selectively chemically functionalized, and reaction of the first click chemical moiety of the functionalized organic polymer and the second click chemical moiety of the complementary reactant enables chemical versatility because of the variety of click reactions available and their selectivity (paragraph [0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyte binding layer of modified Kim to incorporate the teachings of functionalized patternable materials including functionalizable polymers of Ofir (abstract; paragraphs [0062],[0065]) to provide: wherein the analyte binding layer is chosen from the group consisting of reactive silane, a functionalizable hydrogel, a functionalizable polymer, and mixtures and combinations thereof. Doing so would have a reasonable expectation of successfully improving rapid and facile manufacturing of a selectively chemically functionalized article as taught by Ofir (paragraph [0062]).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. an analyte binding layer as a functionalizable polymer) by known methods with no change in their respective functions (i.e. sensitive detection of an analyte), and the combinations yielded nothing more than predictable results (i.e. providing the analyte binding layer as a functionalizable polymer would yield nothing more than the obvious and predictable result of enabling sensitive detection of an analyte). See MPEP 2143(A).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Perbost and Ofir as applied to claim 6 above, and further in view of Charych et al. (US 20020055125 A1).
Regarding claim 7, while Kim teaches coupling of probes includes silane linkers (paragraph [0088]), modified Kim fails to teach wherein the analyte binding layer comprises at least one of acrylamide copolymers and condensed silanes.
Charych teaches a protein-binding array (abstract) comprising array elements on a planar substrate (abstract). Charych teaches an anchoring group may be used to bond a protein-binding agent to a substate surface, such as an activated silane that can condense with hydroxyls or other silanes to form siloxane bonds (paragraph [0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyte binding layer of modified Kim to incorporate the teachings of silane linkers of Kim (paragraph [0088]) and the teachings of activated silanes that can condense to bind a protein-binding agent to a surface of Charych (paragraph [0044]) to provide: wherein the analyte binding layer comprises at least one of acrylamide copolymers and condensed silanes. Doing so would have a reasonable expectation of successfully improve anchoring or binding of the analyte binding layer to the article.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the analyte binding layer comprising condensed silanes) by known methods with no change in their respective functions (i.e. attachment of the analyte binding layer to a surface), and the combinations yielded nothing more than predictable results (i.e. providing the analyte binding layer with condensed silanes would yield nothing more than the obvious and predictable result of enabling anchoring or binding of the analyte binding layer to the article). See MPEP 2143(A).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim in view of Perbost as applied to claim 1 above, and further in view of Hartman et al. (US 20040142495 A1; cited in the IDS filed 04/19/2023).
Regarding claim 11, modified Kim fails to teach the article of claim 1, further comprising an adhesive layer on the second major surface of the flexible carrier film.
Hartman teaches an article for detecting the presence or absence of an analyte (abstract). Hartman teaches the article includes a facestock film having first and second surfaces, an adhesive layer adjacent to the facestock film second surface, and a detecting system adjacent to the facestock film first surface (paragraph [0010]). Hartman teaches an adhesive label that can be adhered to an inside surface of a clear, vapor-impermeable, plastic-film meat container to analyze contents within a container, such as perishable food (paragraph [0024]). Hartman teaches an adhesive layer (Fig. 1C, element 112) on a second major surface of a carrier film (104), and a release liner (114) releasably adhered to the adhesive layer (112) (paragraph [0025]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the article of modified Kim to incorporate the teachings of an article with an adhesive layer for adhering the article to an area of detection of Hartman (abstract; paragraphs [0010],[0024]-[0025]; Fig. 1C) to provide: the article of claim 1, further comprising an adhesive layer on the second major surface of the flexible carrier film. Doing so would have a reasonable expectation of successfully improving attachment of the article to an area for analysis, therefore improving convenience of use of the article for detection an analyte as discussed by Hartman (paragraph [0024]).
Regarding claim 12, modified Kim fails to teach the article of claim 11, further comprising a support layer on the adhesive layer, wherein the support layer is chosen from the group consisting of a release liner and a rigid substrate.
Hartman teaches an article for detecting the presence or absence of an analyte (abstract). Hartman teaches the article includes a facestock film having first and second surfaces, an adhesive layer adjacent to the facestock film second surface, and a detecting system adjacent to the facestock film first surface (paragraph [0010]). Hartman teaches an adhesive label that can be adhered to an inside surface of a clear, vapor-impermeable, plastic-film meat container to analyze contents within a container, such as perishable food (paragraph [0024]). Hartman teaches an adhesive layer (Fig. 1C, element 112) on a second major surface of a carrier film (104), and a release liner (114) releasably adhered to the adhesive layer (112) (paragraph [0025]). Hartman teaches the release liner (114) can subsequently be removed and the article (100) can be adhesively applied to a substrate (paragraph [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the article of modified Kim to incorporate the teachings of an article with an adhesive layer and release liner for adhering the article to an area of detection of Hartman (abstract; paragraphs [0010],[0024]-[0025],[0033]; Fig. 1C) to provide: the article of claim 11, further comprising a support layer on the adhesive layer, wherein the support layer is chosen from the group consisting of a release liner and a rigid substrate. Doing so would have a reasonable expectation of successfully improving attachment of the article to an area for analysis, therefore improving convenience of use of the article for detection an analyte as discussed by Hartman (paragraph [0024]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, and 9-10 of U.S. Patent No. 12,097,498 (herein, “Patent ‘498”) in view of Kim et al. (US 20090111169 A1) in view of Perbost et al. (US 6171797 B1).
Regarding claim 1, Patent ‘498 recites an article (claim 1), comprising:
a flexible carrier film with a first major surface and a second major surface (claim 1, “flexible structured film with a first major surface and a second major surface”), wherein a first major surface of the flexible carrier film comprises an array of structures extending away therefrom (claim 1, “posts”), wherein at least a portion of the structures comprise:
an inorganic layer (claim 1) with a first major surface and a second major surface (claim 1, the first and second major surfaces are implied since the layer would have two surfaces), wherein the first major surface of the inorganic layer is on the flexible carrier film (claim 1 recites the inorganic layer is on the posts of the flexible structured film),
an analyte binding layer (claim 1) with a first major surface and a second major surface (claim 1, the first and second major surfaces are implied since the analyte binding layer would have two surfaces), the first major surface disposed on the second major surface of the inorganic layer (claim 1, the analyte binding layer is on the inorganic layer, therefore a first major surface of the analyte binding layer is on the second major surface of the inorganic layer), wherein the analyte binding layer is bonded to the inorganic layer (claim 1), and wherein the second major surface of the analyte binding layer comprises at least one functional group selected to bind with a biochemical analyte (claim 1).
Patent ‘498 fails to recite: the analyte binding layer is bonded to the inorganic layer via a network of hydrocarbon linking groups; and recessed features interspersed with the structures, each recessed feature having a floor and walls extending away from the floor, wherein at least a portion of the recessed features are free of the inorganic layer and the analyte binding layer, and further wherein the second major surface of the inorganic layer and the floors of the recessed features comprise etched surfaces.
Kim teaches an article (Fig. 1), comprising: a flexible carrier film (Fig. 1 and paragraph [0045], flexible substrate 100) with a first major surface (top surface of substrate 100) and a second major surface (bottom surface of substrate 100), wherein a first major surface of the flexible carrier film comprises an array of structures extending away therefrom (Fig. 1, array of pads 120 extending from the top surface of substrate 100), wherein at least a portion of the structures comprise: an inorganic layer (Fig. 1, layer of active pads 120; paragraph [0041] teaches the active pads are made of silicon oxide) with a first major surface (bottom surface of active pads 120) and a second major surface (top surface of active pads 120), wherein the first major surface of the inorganic layer is on the flexible carrier film (bottom surface of active pads 120 is on substrate 100), an analyte binding layer (Fig. 1, layer of probes 160) with a first major surface (interpreted as the bottom surface of the probes 160) on the second major surface of the inorganic layer (Fig. 1 shows probes 160 are on the top surface of active pads 120 via elements 140, 142), wherein the analyte binding layer (probes 160) is bonded to the inorganic layer (active pads 120) via a network of linkers (linkers 140), and wherein the second major surface of the analyte binding layer (Fig. 1, interpreted as the top surface of probe 160) comprises at least one functional group selected to bind with a biochemical analyte (paragraphs [0047]-[0048] teach the probes 160 are probes is for a target of biological sample to be analyzed, therefore inherently comprises at least one functional group to bind to a target biological sample, i.e. biochemical analyte); and recessed features interspersed with the structures (Fig. 1, teaches gaps or recesses between pads 120, i.e. structures), wherein at least a portion of the recessed features are free of the inorganic layer and the analyte binding layer (Fig. 1 teaches the gap or recesses between pads 120 are free of the pads 120 and probes 160); and further wherein the second major surface of the inorganic layer (Fig. 1, top surface of active pads 120) and the floors of the recessed features (Fig. 1, interpreted as the bottom floor 100 of the gap or recesses between pads 120) comprise etched surfaces (interpreted as a product-by-process limitation, see MPEP 2113, wherein even though product-by-process claims are limited by and defined by the process, i.e. etched, determination of patentability is based on the product itself, and if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process; since Kim teaches the structures of the claimed second major surface of the inorganic layer and the floors of the recessed features, Kim teaches all of the limitations of the claimed surfaces; paragraphs [0083]-[0086] teaches etching to form the pads on the substrates, therefore, the second major surface of the inorganic layer and floors of the recessed features are etched surfaces). Kim teaches etching to form the pads on the substrates (paragraph [0083]-[0086])
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the structures of Patent ‘498 to incorporate the teachings of recessed features interspersed with the structures and etching of Kim (Fig. 1) to provide: recessed features interspersed with the structures, each recessed feature having a floor and walls extending away from the floor, wherein at least a portion of the recessed features are free of the inorganic layer and the analyte binding layer, and further wherein the second major surface of the inorganic layer and the floors of the recessed features comprise etched surfaces. Doing so would have a reasonable expectation of successfully separating the structures and analyte binding layer for proper analyte detection as taught by Kim (Fig. 1).
Modified Patent ‘498 fails to recite: the analyte binding layer is bonded to the inorganic layer via a network of hydrocarbon linking groups.
Perbost teaches arrays of distinct polymers covalently bonded to the surface of a substrate, the arrays are used for analyte detection (abstract). Perbost teaches the substrate includes flexible substrates (column 3, lines 55-57). Perbost teaches a reactive moiety is bound to a substrate via a linking group (column 5, lines 15-26), wherein suitable linkers include hydrocarbon chains (column 6, lines 25-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyte binding layer of Patent ‘498 to incorporate the teachings hydrocarbon linkers of Perbost (column 5, lines 15-26; column 6, lines 25-29) to provide: the analyte binding layer is bonded to the inorganic layer via a network of hydrocarbon linking groups. Doing so would have a reasonable expectation of successfully binding a reactive moiety, e.g. a probe, to a flexible substrate as taught by Perbost (column 5, lines 15-26; column 6, lines 25-29).
Regarding claim 2, Patent ‘498 further recites wherein the flexible carrier film further comprises an anti-biofouling layer (claim 1).
Regarding claim 3, Patent ‘498 further recites wherein the anti-biofouling layer comprises a material chosen from the group consisting of fluoropolymers, non-aromatic hydrocarbon polymers, cyclic olefin polymers, cyclic olefin copolymers, cyclic block copolymers, silicones, metals, a methyl terminated layer, a noble metal and mixtures and combinations thereof (claim 1, “methylated surface”).
Regarding claim 4, Patent ‘498 further recites wherein the inorganic layer has a thickness of less than 100 nm (claim 2, “less than 200 nm” includes dimensions less than 100 nm).
Regarding claim 5, Patent ‘498 further recites wherein the inorganic layer comprises an oxide of silicon, titanium or aluminum (claim 2).
Regarding claim 6, Patent ‘498 further recites wherein the analyte binding layer is chosen from the group consisting of reactive silane, a functionalizable hydrogel, a functionalizable polymer, and mixtures and combinations thereof (claim 1).
Regarding claim 7, Patent ‘498 further recites wherein the analyte binding layer comprises at least one of acrylamide copolymers and condensed silanes (claim 4).
Regarding claim 8, modified Patent ‘498 fails to recite: wherein the hydrocarbon linking group is at least one methylene unit long, and wherein the hydrocarbon linking group and can be linear, cyclic, branched, or aromatic and can optionally contain heteroatoms.
Perbost teaches arrays of distinct polymers covalently bonded to the surface of a substrate, the arrays are used for analyte detection (abstract). Perbost teaches the substrate includes flexible substrates (column 3, lines 55-57). Perbost teaches a reactive moiety is bound to a substrate via a linking group (column 5, lines 15-26), wherein suitable linkers include hydrocarbon chains, usually of 2 to 12 atoms, which structures may be linear or branched and include one or more features, e.g. annular structures, such as phenyl moieties, heteroatoms, e.g. N, S, O and the like (column 6, lines 25-29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrocarbon linking group of modified Patent ‘498 to incorporate the teachings hydrocarbon linkers that include hydrocarbon chains that can be linear or branched of Perbost (column 5, lines 15-26; column 6, lines 25-29) to provide: wherein the hydrocarbon linking group is at least one methylene unit long, and wherein the hydrocarbon linking group and can be linear, cyclic, branched, or aromatic and can optionally contain heteroatoms. Doing so would have a reasonable expectation of successfully binding a reactive moiety, e.g. a probe, to a flexible substrate as taught by Perbost (column 5, lines 15-26; column 6, lines 25-29).
Regarding claim 9, modified Patent ‘498 fails to recite: wherein the hydrocarbon linking group is derived from a condensation of a functional silane onto the inorganic layer, wherein the functional silane comprises functional groups chosen from epoxides, oxiranes, aziridines, isocyanates, alcohols, thiols, amines, chloromethylbenzyl, bromomethylbenzyl, iodomethylbenzyl, alkyl halides, vinyl, carbonyls such as aldehydes and ketones, carboxylic acids, esters, azides, sulfates, phosphates, alkenes, alkynes, (meth)acrylates, (meth)acrylamides, norbornenes, diazonium salts, hydrazines, hydrazones, oximes, halogens, hydroxyls, tetrazoles, tetrazines, benzophenones, aryl azides, halogenated aryl azides, diazos, azos, and mixtures and combinations thereof.
Kim teaches coupling of probes includes silane linkers (paragraph [0088]),
Perbost teaches arrays of distinct polymers covalently bonded to the surface of a substrate, the arrays are used for analyte detection (abstract). Perbost teaches the substrate includes flexible substrates (column 3, lines 55-57). Perbost teaches a reactive moiety is bound to a substrate via a linking group (column 5, lines 15-26), wherein suitable linkers include hydrocarbon chains (column 6, lines 25-29). Perbost teaches a substrate or solid support may be prepared with conventional silanization procedures using silanes (column 6, lines 30-49). Perbost teaches attaching a probe to a substrate includes preparing a surface with a linker reacted with a complementary functional group, such as an amine, hydroxyl, hydrazide, or carboxyl group (column 9, lines 21-39). Perbost teaches reactive groups include halogens (column 5, lines 38-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the hydrocarbon linking group of modified Patent ‘498 to incorporate the teachings of silane linkers of Kim (paragraph [0088]) and the teachings of conventional silanization procedures using silanes, and linkers with functional groups such as amine, hydroxyl, hydrazide, carboxyl group, or halogens of Perbost (column 5, lines 15-26; column 5, lines 38-47; column 6, lines 25-29; column 6, lines 30-49; column 9, lines 21-39) to provide: wherein the hydrocarbon linking group is derived from a condensation of a functional silane onto the inorganic layer, wherein the functional silane comprises functional groups chosen from epoxides, oxiranes, aziridines, isocyanates, alcohols, thiols, amines, chloromethylbenzyl, bromomethylbenzyl, iodomethylbenzyl, alkyl halides, vinyl, carbonyls such as aldehydes and ketones, carboxylic acids, esters, azides, sulfates, phosphates, alkenes, alkynes, (meth)acrylates, (meth)acrylamides, norbornenes, diazonium salts, hydrazines, hydrazones, oximes, halogens, hydroxyls, tetrazoles, tetrazines, benzophenones, aryl azides, halogenated aryl azides, diazos, azos, and mixtures and combinations thereof. Doing so would have a reasonable expectation of successfully binding a reactive moiety, e.g. a probe, to a flexible substrate as taught by Perbost (column 5, lines 15-26; column 6, lines 25-29).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. silane linkers with functional groups such as amines and carboxylic acids) by known methods with no change in their respective functions (i.e. attachment of the analyte binding layer to a surface), and the combinations yielded nothing more than predictable results (i.e. providing the linking group with silane linkers with functional groups such as amines and carboxylic acids would yield nothing more than the obvious and predictable result of enabling linking or binding of the analyte binding layer to the article). See MPEP 2143(A).
Regarding claim 10, Patent ‘498 further recites wherein the structures comprise posts with a diameter of 10 nm to 10,000 nm (claim 5).
Regarding claim 11, Patent ‘498 further recites the article of claim 1, further comprising an adhesive layer on the second major surface of the flexible carrier film (claim 9).
Regarding claim 12, Patent ‘498 further recites the article of claim 11, further comprising a support layer on the adhesive layer, wherein the support layer is chosen from the group consisting of a release liner and a rigid substrate (claim 10).
Response to Arguments
Applicant’s arguments, see page 5, filed 01/06/2026, with respect to the rejections under 35 U.S.C. 112 have been fully considered and are persuasive. The rejections under 35 U.S.C. 112 of 10/06/2025 has been withdrawn.
Applicant's arguments, see pages 6-8, filed 01/06/2026, with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In response to applicant’s argument that the prior art fails to teach claim 1, specifically new limitation “further wherein the second major surface of the inorganic layer and the floors of the recessed features comprise etched surfaces” (Remarks, pages 6-7), the examiner disagrees.
Kim teaches: further wherein the second major surface of the inorganic layer (Fig. 1, top surface of active pads 120) and the floors of the recessed features (Fig. 1, interpreted as the bottom floor 100 of the gap or recesses between pads 120) comprise etched surfaces (interpreted as a product-by-process limitation, see MPEP 2113, wherein even though product-by-process claims are limited by and defined by the process, i.e. etched, determination of patentability is based on the product itself, and if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process; since Kim teaches the structures of the claimed second major surface of the inorganic layer and the floors of the recessed features, Kim teaches all of the limitations of the claimed surfaces; paragraphs [0083]-[0086] teaches etching to form the pads on the substrates, therefore, the second major surface of the inorganic layer and floors of the recessed features are etched surfaces).
The limitation of “etched surfaces” and applicant’s arguments regarding the prior art failing to teach etch processes that provides the second major surface of the inorganic layer and the floors (Remarks, pages 6-7) are interpreted as product-by-process limitations. MPEP 2113 states even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself; the patentability of a product does not depend on its method of production; if the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process (In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)). Since Kim teaches the structures of the claimed second major surface of the inorganic layer (Fig. 1, top surface of active pads 120) and the floors of the recessed features (Fig. 1, interpreted as the bottom floor 100 of the gap or recesses between pads 120), Kim teaches all of the limitations of the claimed product.
It is suggested for applicant to further incorporate additional limitations to the specific arrangement and materials of elements 220, 218, 224, 212 of Fig. 3A and elements 320, 318, 312 of Fig. 3B to differentiate the claims from the prior art.
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., “particular sequence of steps…a patterned layer 244 is first used to create a topological pattern…”, Remarks, page 8) 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).
Applicant's arguments, see page 8, filed 01/06/2026, with respect to the double patenting rejections, have been fully considered but they are not persuasive. The double patenting rejections are maintained in the view of the amended claims (see above double patenting rejection of claim 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jamshidi et al. (US 20160199832 A1) teaches a droplet actuator (abstract). Jamshidi teaches recessed features (Figs. 44A-44B, wells between pedestals 3720) including a floor (3716) and walls extending upwards (walls of pedestals 3720).
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 HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758