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 .
The Applicants’ response to the office action filed on 19 February 2026 has been considered and acknowledged.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 February 2026 has been entered.
Status of the Application
Claims 23-36, 38,39 and 41-44 are pending. Claims 29-31 are withdrawn.
Claims 23-28, 32-36, 38,39 and 41-44 are under examination.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Leck et al., Henkel et al. and Brown et al.
Claims 23-25, 38, 39 and 41- 44 are rejected under 35 U.S.C. 103 as being unpatentable over Leck et al. (US20140234873) in view of Henkel et al. ("Epitope mapping using peptide microarray in autoantibody profiling." Microarray Technology: Methods and Applications. New York, NY: Springer New York, 2016. 209-224.) and Brown et al. (US20050274885).
Leck et al. teach biochips for analysis of target biomolecules, including proteins, peptides, and polypeptides are known in the art. Furthermore, Leck et al. teach a biochip comprising hydrophilic reaction areas comprising peptide probes that are immobilized to capture target material (e.g. Entire Leck reference and especially …The target matter or precursor thereof may thus be of any nature. Examples include, but are not limited to, … a peptide, a polypeptide, an amino acid, a protein, a synthetic polymer, a biochemical composition, a glycoprotein,… In embodiments where the target matter is for example a protein, a polypeptide, a peptide, …, it may contain an affinity tag… Where the target matter is a protein, a polypeptide, or a peptide, further examples of an affinity tag include, but are not limited to, oligohistidine ( such as a penta- or hexahistidine-tag), polyhistidine, a streptavidin binding tag …, an immunoglobulin domain, maltose-binding protein, glutathione-S-transferase (GST), calmodulin binding peptide (CBP), FLAG-peptide (e.g. of the sequence Asp-Tyr-LysAsp-Asp-Asp-Asp-Lys-Gly), the T7 epitope (Ala-Ser-MetThr-Gly-Gly-Gln-Gln-Met-Gly), maltose binding protein (MBP), the HSY epitope of the sequence Gln-Pro-Glu-LeuAla-Pro-Glu-Asp-Pro-Glu-Asp of herpes simplex virus glycoprotein D, the Vesicular Stomatitis Virus Glycoprotein (VSV-G) epitope of the sequence Tyr-Thr-Asp-Ile-Glu-MetAsn-
Arg-Leu-Gly-Lys, the hemagglutinin (HA) epitope of the sequence Tyr-Pro-Tyr-Asp-Val-Pro-Asp-Tyr-Ala and the "myc" epitope of the transcription factor c-myc of the sequence Glu-G ln-Lys-Leu-Ile-Ser-Glu-Glu-Asp-Leu…as in para 0058, pg. 4).
Furthermore, Leck et al. teach hydrophilic immobilization reaction areas are surrounded by hydrophobic surface(e.g. Entire Leck reference and especially Abstract; para 0063,pg. 5; para 0219,pg. 28; Fig. 1A-C).
Furthermore, Leck et al. teach the biochip comprises a polymer resin surface (e.g. Entire Leck reference and especially para 0088,pg. 9; para 0097-0098, pg. 10-11; para 0272-0273,pg. 33).
Regarding the limitation: “wherein each of the at least one reaction area is hydrophilic and more than one spot comprising the material, a thickener, and a surfactant are present on the reaction area” as recited in claim 23 and the limitation: “wherein the spots are prepared by spotting a solution comprising the biological material, the thickener, and the surfactant on each of the at least one reaction area” as recited in claim 38:
Leck et al. teach hydrophilic immobilization areas comprise a polymer coating, wherein possible polymers include poly (methyl methacrylate ) and a polymethacrylate co-polymer (e.g. Entire Leck reference and especially …Compounds and other matter listed in this review are generally suitable materials for selected surface areas of the immobilisation member of the apparatus of the invention. This surface is patterned in such a way that it includes at least one predefined immobilisation area, for instance a hydrophilic immobilisation area. Such surface patterning may for example be obtained by a surface treatment… Examples of a chemical surface treatment include, but are not limited to exposure to… polydimethylsiloxane (PDMS),y-(3,4-epoxycyclohexyl)ethyltrimethoxysilane, poly (methyl methacrylate ) and a polymethacrylate co-polymer as in para 0098,pg. 10-11).
Furthermore, Leck et al. teach immobilization areas are contacted with sample mixture that includes reaction solution comprises a viscous agent and surfactant (e.g. peptide target as in para 0058, pg. 4; viscous agent as in para 0061, pg. 5; surfactant as in para 0123-0127,pg. 14-15).
Therefore, Leck et al. teach biochips are known in the art comprising a substrate comprising a resin surface, wherein hydrophilic reaction areas reside on the resin surface and wherein the resin substrate is contacted with a solution comprising peptide target, a thickener and a surfactant.
Furthermore, prior to the effective filing date of the claimed invention, Henkel et al. teach peptide spotting buffers for preparing a peptide array, i.e. biochip, are known in the art, wherein the buffer is prepared by combining glycerol, i.e. thickening agent glycerin, and Triton X 100, i.e. a surfactant, and subsequently adding sample peptides to this buffer prior to spotting on a substrate (e.g. Entire Henkel reference and especially Fig. 1, pg. 211; steps 6-8, Section 3.3 Peptide and Protein Preparation, pg. 214).
Therefore, as Leck et al. and Henkel et al. both teach biochip compositions, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the biochip of Leck et al. comprising a substrate comprising a resin surface, wherein hydrophilic reaction areas reside on a resin surface and wherein the resin substrate is contacted with a solution comprising a thickener and a surfactant to include the features of peptide spotting buffers for preparing a peptide biochip, wherein the buffer is prepared by combining glycerol, i.e. thickening agent glycerin, and Triton X 100, i.e. a surfactant, and subsequently adding sample peptides to this buffer prior to spotting on a substrate as taught by Henkel et al. because as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a biochip. Furthermore, Henkel et al. teach the merits of putting a thickening agent and a surfactant in the same peptide spotting buffer (e.g. Triton X-100 is required to reduce the surface tension of water to prevent annular (or donut-shaped) inhomogeneous fluorescent spots ( see Fig. 2 ). Glycerol is primarily used to increase physical
adsorption, and hence, to increase the binding capacity as in Note 8, pg. 219).
Therefore, the combined teachings of Leck et al. and Henkel et al. render obvious the limitations: a biochip, comprising: a biochip substrate comprising a resin-made surface and at least one reaction area on the resin-made surface; and a material which is immobilized on each of the at least one reaction area and comprises a biological material(e.g. peptide capture molecules), wherein each of the at least one reaction area is hydrophilic and more than one spot comprising the material, a thickener, and a surfactant are present on the reaction area (e.g. peptide target, thickening agent glycerin, and Triton X 100), and wherein the biological material is a peptide, and wherein the biochip does not comprise a test sample comprising a target to be tested by the biochip as recited in claim 23.
Regarding the limitation: wherein the material, the thickener, and the surfactant are absent on the reaction area between the spots as recited in claims 23 and 24 and the limitation: wherein the material, the thickener, and the surfactant are absent on the coating layer between the spots as recited in claim 25 :
As noted above, Leck et al. teach hydrophilic immobilization reaction areas are surrounded by hydrophobic surface(e.g. Entire Leck reference and especially Abstract; para 0063,pg. 5; para 0219,pg. 28; Fig. 1A-C).
Furthermore, Henkel et al. teach applying a buffer comprising glycerin, Triton X 100 and polypeptides in discrete spots to a substrate ( e.g. Entire Henkel reference and especially Fig. 1, pg. 211; steps 6-8, Section 3.3 Peptide and Protein Preparation, pg. 214).
Additionally, prior the effective filing date of the claimed invention, Brown et al. teach arrays, i.e. biochip, wherein sample solutions are retained in discrete areas of the substrate are known in the art. Specifically, Brown et al. teach a sample plate for analysis of biomolecules (e.g. para 0005, pg. 1) comprising a plurality of sample regions (i.e. reaction spots), wherein each of the sample regions are discrete entities separated by a section of the plate surface. Furthermore, Brown et al. teach arrays may have additional features to maintain discrete reaction spots, such as a circular groove that surrounds each sample region (e.g. para 0009-0012, pg. 1; para 0017, pg. 1; para 0026, pg. 2; para 0036-0040, pg. 2; para 0112,para 0116, pg. 5; sample area designated as item 5 is a discrete feature in an area encircled by moat designated as item 3 in Fig. 1a) and the grooves of each individual sample regions do not intersect (e.g. Fig. 1a and as below).
Furthermore, like Leck, Brown et al. teach each sample region is surrounded by inert area that does not retain sample, i.e. a section of the carbon-containing PTFE or polystyrene hydrophobic surface that is inert (e.g. Fig. 1 a and b). The presence of the hydrophobic surface allows improved retention of sample volume on the sample region (e.g. para 0120, pg. 5).
Therefore, as Leck et al., Henkel et al. and Brown et al. all teach substrates comprising individual reaction spots to which biomolecules are retained, it would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Leck et al. and Henkel et al. to include a plurality of discrete reaction spots, wherein each reaction spot is also by an area of the inert hydrophobic surface as taught by Brown et al. because a person of ordinary skill in the art would recognize that incorporating hydrophobic areas that encircle each individual reactions spot would promote improved sample retention (e.g. allowing improved retention of sample volume on the sample region as in para 0120,pg. 5, Brown).
Therefore, the combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious claim 23.
Furthermore, as at least Leck et al. and Brown et al. teach hydrophilic features surrounded by hydrophobic regions , the combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious claim 24.
Regarding claims 38 and 39:
These claims depend from claims 23 and 24 which recite a product invention.
Therefore, claims 38 and 39 are considered product-by-process claims:
See MPEP 2113. PRODUCT-BY-PROCESS CLAIMS ARE NOT LIMITED TO THE MANIPULATIONS OF THE RECITED STEPS, ONLY THE STRUCTURE IMPLIED BY THE STEPS
“[E]ven 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) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.).
Therefore, as the combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious the claimed biochip of claims 23 and 24, these combined teachings also render obvious claims 38 and 39.
Furthermore, as Henkel et al. teach applying a buffer comprising glycerin, Triton X 100 and sample peptides in discrete spots to a substrate (e.g. Entire Henkel reference and especially Fig. 1, pg. 211; steps 6-8, Section 3.3 Peptide and Protein Preparation, pg. 214), the combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious claims 41 and 42.
Furthermore, as at least Leck et al. teach polypeptide capture molecules( e.g. para 0058,pg. 4, Leck), the combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious claims 43 and 44.
Leck et al., Henkel et al., Brown et al. and Matsudaira et al.
Claims 25-28 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Leck et al., Henkel et al. and Brown et al., as applied to claims 23-28,34, 38, 39, 43 and 44 above, and further in view of Matsudaira et al. ("Automated microfluidic assay system for autoantibodies found in autoimmune diseases using a photoimmobilized autoantigen microarray." Biotechnology progress 24.6 (2008): 1384-1392.).
The combined teachings of Leck et al., Henkel et al. and Brown et al. as applied above are incorporated in this rejection.
The combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious a biochip comprising a polymer resin surface and hydrophilic areas; at least one reaction region comprising multiple reaction spots, each region comprising thickening agent and surfactant and a biological material that is a peptide, wherein the biochip does not comprise a test sample comprising a target to be tested by the biochip, wherein the reaction spots retain the sample comprising target and the sample, thickener and surfactant are absent on the reaction area between the spots.
However, the combined teachings of Leck et al., Henkel et al. and Brown et al. do not expressly teach claims 25-28 and 34.
However, prior to the effective filing date of the claimed invention, Matsudaira et al. teach biochips are known in the art comprising a polystyrene plate comprising a coating of Poly(polyethylene glycol methacrylate (PPEGM), a photocrosslinking agent, a 4,4 '-diazidostiIbene-2,2'disulfonic acid disodium salt (BIS) and a surfactant, Tween 20. Specifically, Matsudaira et al. teach a “photoimmobolization” process to immobilize capture molecules, i.e. autoantigens, that is facilitated by a solution comprising Poly(polyethylene glycol methacrylate)(PPEGM), Tween-20 and 4,4 '-diazidostiIbene-2,2'disulfonic acid disodium salt (BIS), wherein the autoantigens include peptides Ro/SS-A (52 kDa), Ro/SS-A (60kDa), U1snRNP (68 kDa), U-snRNA B/B’, Jo-1, CENP-B;SS-B/La, Scl-70 ; and SS-A and Sm (e.g. Entire Matsudaira reference and especially Fig. 1, pg. 1385; Reagents and sera section - Photoimmobilization of autoantigens section, Materials and Methods section, pg. 1386; autoantigens as listed in 1st para, Reagents and sera section; Photoimmobilization was performed as illustrated in Figure 1. An aqueous solution of BIS (2.5 mg/mL), PPEGM (50 mg/mL), and Tween 20 (5%) were mixed in phosphate-buffered solution (PBS) and spin-coated on the plate… as in 1st para, Photoimmobilization of autoantigens section).
Furthermore, Matsudaira et al. teach the chip comprises discrete spots (e.g. Entire Matsudaira reference and especially … Autoantigens (1 mg/mL) were dissolved in deionized water with BIS (0.1 mg/mL), the aqueous solutions were microspotted onto the plate (50 nL) with a microarray spotter (PixSis-4500,Cartesian, Irvine, CA) and the droplets were dried… as in 1st para, Photoimmobilization of autoantigens section, pg. 1386; Fig. 2, pg. 1386).
Furthermore, Matsudaira et al. teach these prepared autoantigen – immobilized plates are subsequently used to capture proteins in serum, which were detected using HRP-labeled anti-IgG antibody(e.g. Entire Matsudaira reference and especially Microarray assay procedure section, pg. 1386-1387; Fig. 4-6, pg. 1388-1389).
Furthermore, Matsudaira et al. teach the merits of PEG polymer coatings for microarray analysis of various molecules (e.g. Entire Matsudaira reference and especially …We have developed a new photoimmobilization method incorporating a nonbiofouling polymer, polyethylene glycol.31,41–44 In particular, a polymer carrying polyethylene glycol in the side chains poly(polyethylene glycol methacrylate) (PPEGM), which is a vinyl polymer containing polyethylene glycol (PEG) brush, has been employed in previous studies, and it was demonstrated that PPEGM was more effective for antibiofouling than the usual PEG.31,41 By this method, nonspecific interaction was reduced, and various types of molecules were easily immobilized in the microarray by the same method. In addition, our photoimmobilization method is very convenient because the system consists only of a mixture of matrix polymer and photoreactive crosslinker. In this investigation, we applied the method to immobilization of autoantigens and developed an automated assay system using a microfluidic device… as in 2nd para, pg. 1386).
Therefore, as Matsudaira et al. also teach biochip compositions, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the biochip of Leck et al. , Henkel et al. and Brown et al. comprising a substrate comprising a resin surface, wherein hydrophilic reaction areas reside on a resin surface and wherein the resin substrate is contacted with a solution comprising a thickener and a surfactant to include the features of a polystyrene chip comprising discrete spots comprising capture peptide molecules, such as autoantigens, that are photoimmobilized with coating comprising Poly(polyethylene glycol methacrylate)(PPEGM), wherein the coated substrate is prepared prior to exposure to target sample as taught by Matsudaira et al. because as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a biochip. Furthermore, Matsudaira et al. teach the merits of PEG polymer coatings for microarray analysis of various molecules (e.g. 2nd para, pg. 1386).
Furthermore, as Matsudaira et al. teach a “photoimmobilization” process to immobilize capture molecules, i.e. autoantigens, that is facilitated by a solution comprising Poly(polyethylene glycol methacrylate)(PPEGM) and Tween 20 (e.g. Entire Matsudaira reference and especially Fig. 1, pg. 1385; Reagents and sera section - Photoimmobilization of autoantigens section, Materials and Methods section, pg. 1386), the combined teachings of Leck et al., Henkel et al. , Brown et al. and Matsudaira et al. render obvious claims 25-27.
Furthermore, as Matsudaira et al. teach a polystyrene chip comprising discrete spots comprising capture peptide molecules, such as autoantigens, that are photoimmobilized with coating comprising a PEG polymer thickener, i.e. (PPEGM), wherein Matsudaira et al. teach the merits of PEG polymer coatings for microarray analysis of various molecules (e.g. Entire Matsudaira reference and especially Fig. 1, pg. 1385; Fig. 2, pg. 1386; Reagents and sera section - Photoimmobilization of autoantigens section, Materials and Methods section, pg. 1386; merits of PEG polymer coating as in 2nd para, pg. 1386) and Henkel et al. teach a spotting buffer comprising the thickener glycerin and the surfactant Triton X-100, the combined teachings of Leck et al., Henkel et al., Brown et al. and Matsudaira et al. render obvious claims 28 and 34.
Leck et al., Henkel et al., Brown et al. and Ito et al.
Claim 25-28 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Leck et al., Henkel et al. and Brown et al., as applied to claims 23-28,34, 38, 39, 43 and 44 above, and further in view of Ito et al. (US20110065126).
The combined teachings of Leck et al., Henkel et al. and Brown et al. as applied above are incorporated in this rejection.
The combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious a biochip comprising a polymer resin surface and hydrophilic areas; at least one reaction region comprising multiple reaction spots, each region comprising thickening agent and surfactant and a biological material that is a peptide, wherein the biochip does not comprise a test sample comprising a target to be tested by the biochip, wherein the reaction spots retain the sample comprising target and the sample, thickener and surfactant are absent on the reaction area between the spots.
Regarding claims 25-28 and 34:
Prior to the effective filing date of the claimed invention, like Leck et al., Henkel et al. and Brown et al., Ito et al. teach substrates to which biological substance is immobilized. Furthermore, Ito et al. teach the substrate is composed of polystyrene, polypropylene , polycarbonate or acrylic resin (e.g. Entire Ito reference and especially para 0030, pg. 2) and are coated with a layer comprising a water soluble polymer and photocrosslinking agent to facilitate immobilization of target substance(e.g. Entire Ito reference and especially para 0030- 0067, pg. 2-6; photoimmobilization as in para 0062-0066; mixture as in para 0050).
Furthermore, Ito et al. teach multiple polymers including PEG polymers, including polyethylene glycol methacrylate ( e.g. Entire Ito reference and especially para 0036,pg. 2-3).
Furthermore, Ito et al. teach multiple biological substances are immobilized including polypeptides (e.g. Entire Ito reference and especially para 0060,pg. 6).
Therefore, as Leck et al., Henkel et al., Brown et al. and Ito et al. all teach biochip compositions, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the biochip of Leck et al., Henkel et al. and Brown et al. to include water soluble polymers and immobilized capture molecules as taught by Ito et al. because as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a biochip.
Therefore, as Ito et al. teach photoimmobilization of polypeptides on a substrate composed of polystyrene, polypropylene , polycarbonate or acrylic resin comprising a coating comprising water soluble polymers are known in there art, including polyethylene glycol methacrylate (e.g. Entire Ito reference and especially para 0030- 0067, pg. 2-6; immobilized polypeptides as in para 0060; photoimmobilization as in para 0062-0066; mixture as in para 0050), the combined teachings of Leck et al., Henkel et al., Brown et al. and Ito et al. render obvious claims 25-27.
Furthermore, as Ito et al. teach photoimmobilization of polypeptides on a substrate composed of polystyrene, polypropylene , polycarbonate or acrylic resin comprising a coating comprising multiple water soluble polymers are known in there art, including PEG polymers, including polyethylene glycol methacrylate (e.g. Entire Ito reference and especially para 0030- 0067, pg. 2-6; immobilized polypeptides as in para 0060; photoimmobilization as in para 0062-0066; mixture as in para 0050)and Henkel et al. teach a spotting buffer comprising the thickener glycerin and the surfactant Triton X-100, the combined teachings of Leck et al., Henkel et al., Brown et al. and Ito et al. render obvious claims 28 and 34.
Leck et al., Henkel et al., Brown et al. and Sakamoto et al.
Claim 32, 33, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Leck et al., Henkel et al. and Brown et al., as applied to claims 23-28,34, 38, 39, 43 and 44 above, and further in view of Sakamoto et al. (US20130028789).
The combined teachings of Leck et al., Henkel et al. and Brown et al. as applied above are incorporated in this rejection.
The combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious a biochip comprising a polymer resin surface and hydrophilic areas; at least one reaction region comprising multiple reaction spots, each region comprising thickening agent and surfactant and a biological material that is a peptide, wherein the biochip does not comprise a test sample comprising a target to be tested by the biochip, wherein the reaction spots retain the sample comprising target and the sample, thickener and surfactant are absent on the reaction area between the spots.
However, the combined teachings of Leck et al., Henkel et al. and Brown et al. do not expressly teach claims 32, 33, 35 and 36.
Prior to the effective filing date of the claimed invention, Sakamoto et al. teach kits are known in the art comprising lab chips, i.e. biosensors, that are sealed in packaging material with a desiccating agent (e.g. Entire Sakamoto reference and especially para 0056-0057, pg. 2; para 0086,pg. 4; Fig. 4A). Sakamoto et al. teach kits are sealed with an inert gas (e.g. Entire Sakamoto reference and especially para 0081,pg. 4).
Therefore, as Leck et al., Henkel et al., Brown et al. and Sakamoto et al. all teach biochip compositions, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the biochip of Leck et al., Henkel et al. and Brown et al. to include features of a kits comprising lab chips that are sealed with an inert gas in packaging material with a desiccating agent as taught by Sakamoto et al. because as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a biochip.
Therefore, the combined teachings of Leck et al., Henkel et al., Brown et al. and Sakamoto et al. render obvious the limitation: wherein the package is prepared by packing the biochip by packaging together with inert gas as recited in claims 32 and 35.
Furthermore, the combined teachings of Leck et al., Henkel et al., Brown et al. and Sakamoto et al. render obvious claims 33 and 36.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Patent Application No. 16/487,670
Claims 23-28, 32-36, 38,39 and 41-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-42, 45 and 48 of copending Application No. 16/487,670 in view of Leck et al. (US20140234873); Henkel et al. ("Epitope mapping using peptide microarray in autoantibody profiling." Microarray Technology: Methods and Applications. New York, NY: Springer New York, 2016. 209-224.); Brown et al. (US20050274885); Matsudaira et al. ("Automated microfluidic assay system for autoantibodies found in autoimmune diseases using a photoimmobilized autoantigen microarray." Biotechnology progress 24.6 (2008): 1384-1392.); Ito et al. (US20110065126); and Sakamoto et al. ( US20130028789).
Claims 29-42, 45 and 48 of copending Application No. 16/487,670 recite a biochip comprising a polymer surface and an array of immobilization features, i.e. spots, comprising a photocrosslinking agent having at least two photoreactive groups.
Claims 29-42, 45 and 48 of copending Application No. 16/487,670 do not expressly teach a biochip also comprising a thickening agent and a surfactant.
However, these features are known in the art.
As discussed in the current rejections, the combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious claims 23-25, 38, 39 and 41- 44. Furthermore, the additional teachings of Matsudaira et al. render obvious claims 25-28 and 34. Furthermore, the additional teachings of Ito et al. render obvious claims 25-28 and 34. Furthermore, the additional teachings of Sakamoto et al. render obvious claims 32,33, 35 and 36.
Therefore, as claims 29-42, 45 and 48 of copending Application No. 16/487,670; Leck et al., Henkel et al., Brown et al., Matsudaira et al., Ito et al. and Sakamoto et al. all teach biochip compositions, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the biochip of claims 29-42, 45 and 48 of copending Application No. 16/487,670 and to include the combined teachings of Leck et al., Henkel et al., Brown et al., Matsudaira et al., Ito et al. and Sakamoto et al. as discussed in the rejections above because as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a biochip as recited by the instant invention.
This is a provisional nonstatutory double patenting rejection.
Patent Application No.18/043,368
Claims 23-28, 32-36, 38,39 and 41-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/043,068 in view of Leck et al. (US20140234873); Henkel et al. ("Epitope mapping using peptide microarray in autoantibody profiling." Microarray Technology: Methods and Applications. New York, NY: Springer New York, 2016. 209-224.); Brown et al. (US20050274885); Matsudaira et al. ("Automated microfluidic assay system for autoantibodies found in autoimmune diseases using a photoimmobilized autoantigen microarray." Biotechnology progress 24.6 (2008): 1384-1392.); Ito et al. (US20110065126); and Sakamoto et al. ( US20130028789).
Claims 1-20 of copending Application No. 18/043,068 recite a biochip comprising one or more reaction spots comprising immobilized material.
Claims 1-20 of copending Application No. 18/043,068 do not expressly teach a biochip also comprising a thickening agent and a surfactant.
However, these features are known in the art.
As discussed in the current rejections, the combined teachings of Leck et al., Henkel et al. and Brown et al. render obvious claims 23-25, 38, 39 and 41- 44. Furthermore, the additional teachings of Matsudaira et al. render obvious claims 25-28 and 34. Furthermore, the additional teachings of Ito et al. render obvious claims 25-28 and 34. Furthermore, the additional teachings of Sakamoto et al. render obvious claims 32,33, 35 and 36.
Therefore, as claims 1-20 of copending Application No. 18/043,068; Leck et al., Henkel et al., Brown et al., Matsudaira et al., Ito et al. and Sakamoto et al. all teach biochip compositions, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the biochip of claims 1-20 of copending Application No. 18/043,068 and to include the combined teachings of Leck et al., Henkel et al., Brown et al., Matsudaira et al., Ito et al. and Sakamoto et al. as discussed in the rejections above because as a person of ordinary skill in the art would recognize that these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a biochip as recited by the instant invention.
This is a provisional nonstatutory double patenting rejection.
Response to the Arguments
Any rejection not reiterated or specifically addressed has been overcome by amendment.
Regarding Applicants’ arguments and amendments, they are persuasive. The 112(b) rejections are withdrawn.
Regarding Applicants’ arguments that the previously cited art does not meet the requirements of the amended claims: New rejections are set forth to address the instant claims. However, previously cited references teach art relevant to the amended claims and therefore are included in the new rejections.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHANA S KAUP whose telephone number is (571)272-6897. The examiner can normally be reached on M-F 7am-7pm EST.
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/SAHANA S KAUP/ Supervisory Primary Examiner, Art Unit 1612
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