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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The present application was filed on 10/15/2021 and is a CON of PCT/JP2020/017278, filed on 04/22/2020. Acknowledgment is also made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d) to Application No. 2019-085963, filed on 04/26/2019 in Japan.
Status of the Claims
Claims 1-2 and 5-25 are pending; claims 1 is amended, claims 3-4 are canceled; claims 20-23 are withdrawn; claim 25 is newly recited. Claims 1-2, 5-19 and 24-25 are examined below.
Maintained Rejections
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.
Claims 1-2, 5, 7-15, 17-19 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over by Naoki et al. (JP 2012013687 A) ("Naoki") in view of Ueya (WO 2016039293).
Regarding claims 1-2 and 14-15, Naoki teaches a particle comprising a magnetic particle containing a magnetic material (“the present invention relates to magnetic marker particles that can be used in the biotechnology field or life science field” para. 1, “The material of the magnetic particle main body corresponding to the core portion of the magnetic marker particle is not particularly limited as long as the particle becomes magnetic as a whole” para. 24, “Depending on the application and surface treatment, a magnetic metal or alloy such as iron or nickel can be used” para. 61), wherein the magnetic particle has a resin on a surface (“The magnetic marker particles of the present invention have a magnetic particle or spherical magnetic particle (hereinafter also referred to as “core particle”) as a core and a polymer deposited on the surface of the core particle” para. 59). Note that the “polymer deposited on the surface of the core particle” is effectively analogous to a resin as per the specification paragraphs 32 and 34. Naoki further teaches wherein the particle has a number average particle diameter of 0.7 µm to 0.9 µm (“The average particle size (primary particle size) of the magnetic marker particles of the present invention is preferably about 5 nm to about 1000 nm… calculating the particle size as the number average” para. 63, “Regarding dispersibility, the “particle size of magnetic marker particles in a buffer solution (i.e., dispersed particle size)” measured using a dynamic light scattering method (DLS method) is smaller than the conventional particle size… In this respect, in a preferred embodiment of the magnetic marker particle of the present invention, the dispersion particle diameter Dp is 200 to 700 nm” paragraphs 53-54), wherein the magnetic material has a particle diameter of at least 0.1 µm (“the “core particle” of the magnetic marker particle of the present invention may be…a spherical particle” paragraph 61, paragraph 54). Note that although Naoki fails to use the language “wherein the magnetic material has a particle diameter of at least 0.1 µm”, the teaching that “the “core particle” of the magnetic marker particle of the present invention may be…a spherical particle” (paragraph 61), together with the teaching that “the dispersion particle diameter Dp is 200 to 700 nm” (paragraph 54) effectively addresses wherein the magnetic material has a particle diameter of at least 0.1 µm because the core particle, which contains the magnetic material, would inherently have a diameter of at least 100 nm. Naoki further teaches wherein the particle has a density of 5.1 g/cm3 to 10.0 g/cm3, wherein the particle has a density of 5.1 g/cm3 to 6.5 g/cm3 (“The density of the magnetic marker particles of the present invention is preferably 3 to 9 g / cm 3, more preferably 4 to 6 g / cm 3” para. 64), and wherein the resin has a functional group capable of binding a ligand, wherein the functional group capable of binding a ligand is a carboxyl group (“the polymer comprises a combination of carboxyl…” para. 15, “The magnetic marker particles of the present invention are preferably formed by immobilizing “biological substance-binding substance” and / or “biological substance-binding functional group”…. the “biological substance-binding functional group” includes a carboxyl group” para. 76). Naoki further teaches wherein sedimentation speed determined by Stokes' law is 1.0×10-5 (cm/s) or more (“[a]lthough VB in the above formula 1 depends on the particle size, it can be understood from the Stokes equation that the particle size dependence can be eliminated by dividing VB by the square of the particle size. Therefore, in Expression 3, the value is divided by the square of the primary particle diameter, and the sedimentation velocity V ′ in which the influence of the degree of aggregation is left is grasped. In the present invention, the value V ′ of the sedimentation velocity of the magnetic marker particles represented by Equation 3 is in the range of 1.0× 10 - 6 to 1.0 × 10 – 4” para. 17, “Here, the sedimentation velocity VB represented by Equation 1, which will be described in detail later, can be equated with the so-called "sedimentation velocity of dispersed particles in a buffer solution under static conditions"” para. 51, “Therefore, in the following formula 1, the dispersion stability is evaluated in consideration of eliminating the influence of the centrifugal force. VB = Vs / A….(1)…By using Equation 1, a value independent of the centrifugal force is obtained, and the dispersion stability of the magnetic marker particles in the buffer solution can be directly compared” para. 80).
Naoki fails to teach volume average particle diameter.
Ueya teaches “a solid-phase carrier, a ligand-bound solid-phase carrier, a method for detecting or separating a target substance, and a method for producing the solid-phase carrier” (para. 1). Ueya further teaches that “[t]he solid-phase carrier according to the present invention is obtained by bonding a polymer containing a structural unit represented by formula (1) and a structural unit represented by formula (2)” (para. 17), “[t]he polymer preferably forms a polymer brush on the solid-phase carrier surface” (para. 54). Ueya further teaches that in “(Structural Unit (2))” (para. 32) “R is a reactive functional group (carboxy group)” (para. 33). Ueya further teaches that “the form of the solid-phase carrier of the present invention is not particularly limited, and may be any of a particle, …but from the viewpoint of ease of detection or separation of a target substance, particles are preferable, and magnetic particles are more preferable” (para. 56). Ueya further teaches that “[t]he average particle diameter (volume average particle diameter) of the solid phase carrier according to the present invention is preferably 0.1 to 500 μm, more preferably 0.2 to 50 μm, and still more preferably 0.3 to 10 μm…[w]ith such a range, when the solid-phase carrier is a magnetic particle, the magnetism collection speed is increased, the handleability is improved, the ligand binding amount is increased, and the detection sensitivity and the like are improved” (para. 61).
With regards to the claimed range of volume average particle diameter of 0.7 µm to 0.9 µm, the prior art teaches a range of 0.3 µm to 10 µm. In such a case, since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” MPEP 2144.05.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Naoki to rely on the volume average particle diameter of .7 µm to 0.9 µm taught by Ueya because Ueya suggests that with such a range, the magnetism collection speed is increase, the handleability is improved, the ligand binding amount is increased, and the detection sensitivity and the like are improved. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Naoki and Ueya teach a magnetic particle with a resin on its surface having a carboxy functional group capable of binding a ligand that can be used in the biotechnology field. Furthermore, Naoki teaches an average diameter of 0.7 µm.
Regarding claim 5, Naoki fails to teach wherein the resin has a weight average molecular weight of 10,000 or more.
Ueya teaches wherein the resin has a weight average molecular weight of 10,000 or more (“[t]he weight average molecular weight (Mw) of the polymer is preferably 1,000 to 100,000, more preferably 3,000 to 50,000, and particularly preferably 5,000 to 30,000” para. 55). Ueya further suggests that this aids in the suppression of non-specific adsorption and the enhancement of the activity of a ligand bound to a solid phase carrier (“Molecular weight distribution (Mw)／ The Mn is preferably 1.0 to 2.5, more preferably 1.0 to 2.0, and still more preferably 1.0 to 1.5, from the viewpoint of suppressing non-specific adsorption and enhancing the activity of a ligand bound to a solid phase carrier” para. 55).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Naoki to rely on the resin having a weight average molecular weight of 10,000 or more taught by Ueya because Ueya suggests that this aids in the suppression of non-specific adsorption and the enhancement of the activity of a ligand bound to a solid phase carrier. A person having ordinary skill in the art would have had a reasonable expectation of success because both Naoki and Ueya teach magnetic particles for binding a target substance having a resin on its surface.
Regarding claim 7, Naoki in view of Ueya further suggest wherein the resin has units derived from styrene and acrylic acid (“In a preferred embodiment, in the production method of the present invention, the “compound having a polymerizable site and a carboxyl group” is preferably acrylic acid. The “compound having a polymerizable site and a sulfo group” is preferably styrene sulfonic acid” para. 31 of Naoki. “Examples of the other structural units include…styrenes” para 43 of Ueya, “METHOD FOR MANUFACTURING SOLID-PHASE CARRIER…method of preparing a polymerization initiating group-containing carrier, polymerizing a monomer (11)constituting the structural unit (1) and a monomer (12) having a functional group capable of introducing a carboxy group…Examples of the monomer having a carboxy group, an amino group or a tosyl group include (meth) acrylic acid” para. 62 of Ueya).
Regarding claim 8, the recitation of “suitable for a specimen test” does not convey any clear structural limitations to the particle itself. As such, the particle of Naoki in view of Ueya would also be capable of performing a specimen test. Nonetheless, Naoki in view of Ueya further suggest wherein the particle is suitable for a specimen test (“Uses of Magnetic Marker Particles ⟩⟩ The use of the magnetic marker particles of the present invention will be described. As described above, the magnetic marker particles of the present invention are used for testing drugs such as in vitro diagnosis, collection and testing of biological materials such as DNA and proteins in the medical and research fields, and drug delivery systems (DDS)… When the specimen for in vitro diagnosis is a body fluid such as blood, or when used for DDS applications, blood is a kind of buffer solution in which a large amount of salt is present, and the characteristics of these particles are extremely important” para. 114 of Naoki).
Regarding claims 9-13, Naoki in view of Ueya suggest wherein a number of magnetic materials in the magnetic particle is 1, and wherein the magnetic particle contains the magnetic material at a content of 100%, wherein the magnetic material contains a metal, iron or nickel, wherein the magnetic material contains an iron or nickel atom at a content of 80% to 100% (“As long as it has the above magnetic properties, the “core particle” of the magnetic marker particle of the present invention may be any particle or spherical particle …a magnetic metal or alloy such as iron or nickel can be used” para. 61 of Naoki). Note that although Naoki fails to use the language “wherein the magnetic particle contains the magnetic material at a content of 100%, wherein the magnetic material contains an iron or nickel atom at a content of 80% to 100%”, the teaching that the core particle can be a magnetic metal such as iron or nickel, inherently provides a content of magnetic material of 100% and content of iron or nickel atom of 80% to 100% because a nickel or iron core particle would necessarily include 100% of magnetic material and a content of iron or nickel atom of 80% to 100%.
Regarding claims 17-18, Naoki in view of Ueya suggest an affinity particle comprising the particle of claim 1 and a ligand that binds to the particle, wherein the ligand is an antibody or an antigen (paragraph 28 of Naoki, “The ligand-binding solid-phase carrier of the present invention is obtained by binding a ligand to a solid-phase carrier of the present invention. The ligand may be a molecule that binds to a target substance, but examples thereof include: an antibody; an antigen” para. 74 of Ueya). Ueya further teaches that “an antibody or an antigen is preferable from the viewpoint of being a ligand-bound solid-phase carrier suitable for a diagnostic agent or the like” (para. 74).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Naoki to rely on the ligand being an antibody or antigen taught by Ueya because Ueya suggests that this enables its use as a diagnostic agent or the like. A person having ordinary skill in the art would have had a reasonable expectation of success because both Naoki and Ueya teach magnetic particles for binding a target substance having a resin on its surface.
Regarding claim 19, Naoki in view of Ueya teach a test reagent comprising the affinity particle of claim 17 and a dispersion medium for dispersing the affinity particle (“an object of the present invention is to provide magnetic particles (more specifically, magnetic marker particles) exhibiting excellent dispersion stability even in a pH buffer solution, and preferably, practically sufficient in a pH buffer solution. The object is to provide magnetic marker particles exhibiting both dispersion stability and magnetic trapping properties” para. 14 of Naoki, “Further, in the present specification, the “buffer solution” or “pH buffer dispersion” means a fluid having a buffering action to counteract the change in pH when an acid or a base is added. Indicates a “liquid whose pH is kept substantially constant” used in the fields of medical science and bioscience” para. 21 of Naoki).
Regarding claim 25, Naoki in view of Ueya further suggest wherein the magnetic material has the particle diameter of at least 0.7 μm (“The average particle size (primary particle size) of the magnetic marker particles of the present invention is preferably about 5 nm to about 1000 nm” para. 63 of Naoki). Note that although Naoki fails to use the language “the magnetic material has the particle diameter of at least 0.7 μm”, the teaching that the core particle is at least 0.7 μm, (5 nm – 1000 nm) inherently provides the magnetic material having the particle diameter of at least 0.7 μm because the core particle comprises the magnetic material.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Naoki in view of Ueya as applied to claim 1 above, and further in view of Gao and Lu (CN 101178961 A) (hereinafter Gao).
Regarding claim 6, Naoki in view of Ueya address the particle of claim 1 as discussed above.
Naoki in view of Ueya further teach wherein the resin has repeating units represented by formula (3) (“The solid-phase carrier according to any one of claims 1 to 9, wherein the polymer is a block polymer including a first block constituted by repeating a structural unit represented by the formula (1) and a second block constituted by repeating a structural unit represented by the formula (2)” claim 10 of Ueya, para. 33 of Ueya, see formula 2 of Ueya being analogous to formula (3) of the instant claim).
Naoki in view of Ueya fail to teach wherein the resin has repeating units represented by formula (2).
Gao teaches a “water soluble magnetic nano-crystal” (Abstract) “widely applied to…biological (medical) field,… wherein the application of the biological field, comprising:…cell separation and labeling” (Background Technology paragraph 1). Gao teaches that the magnetic nano-crystal has “its surface…decorated with formed in situ poly N-vinyl pyrrolidone or N-vinyl pyrrolidone copolymer formed with other free radical monomer” (Background Technology paragraph 5). Gao further teaches that “poly N-vinylpyrrolidone (PVP) and monomer N-vinyl pyrrolidone (NVP) not only has excellent solubility, chemical stability, film forming property, low toxicity, physiologically inert, bonding ability and protection function, but also can be combined and various inorganic compounds and organic chemical substance. PVP application in the field of medicine is the vitality of important, physiological soluble PVP has a good, not involved in the metabolism of human body and does not form obvious stimulation to the bodily organ… provides a very good water solubility…[and] good biocompatibility” (Background Technology paragraph 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Naoki in view of Ueya to rely on the resin having repeating units represented by formula (2) taught by Gao because Gao teaches that poly N-vinylpyrrolidone (PVP) has low toxicity, is physiologically inert, has bonding ability and protection function, but also can be combined with various inorganic compounds and organic chemical substances. Gao also motivates a person having ordinary skill in the art to use PVP in the field of medicine because it is biocompatible. A person having ordinary skill in the art would have had a reasonable expectation of success given because Gao teaches that N-vinylpyrrolidone (PVP) has excellent solubility, chemical stability and film-forming property.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Naoki in view of Ueya as applied to claim 1 above, and further in view of Usuki et al. (US PGPub 20090029482)-Cite No. 4 of IDS filed on 10/18/2021 (hereinafter Usuki).
Regarding claim 16, Naoki in view of Ueya address the particle of claim 1 as discussed above.
Naoki in view of Ueya fail to teach wherein the resin has a siloxane bond.
Usuki teaches a “functional particle, and method for separation of target substance using the same” (Title). Usuki further teaches that the “particles of the present invention have a "substance or functional group capable of binding to a target substance"” (paragraph 9). Usuki teaches that “[t]he particles of the present invention are high density particles which enable a preferential binding of a target substance thereto and inhibit a binding of "substances other than the target substance" thereto” (Abstract). Usuki teaches wherein the resin has a siloxane bond (“the immobilization of "substance to which a target substance can bind" on the particles may be facilitated by adhering or introducing other substances, for example, a silicon-containing substance (e.g. siloxane, silane coupling agent and sodium silicate) or a resin having a functional group to which a target substance can bind or adhere, to the body of the particle in advance” paragraph 49 “ the above-described method for immobilizing a functional group by the use of siloxane can be employed. Specifically, a compound having a double bond and an epoxy group (e.g. glycidyl methacrylate) is reacted with the Si--H moiety of siloxane” paragraph 94). Usuki further teaches that the siloxane bond “is effective for providing the coating polymer on the surfaces of the particles” (paragraph 69).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Naoki in view of Ueya to rely on the resin having a siloxane bond taught by Usuki because Usuki teaches that “[t]his is effective for providing the coating polymer on the surfaces of the particles” (paragraph 69). A person having ordinary skill in the art would have had a reasonable expectation of success because both Naoki in view of Ueya and Usuki teach particles for binding a target substance having a resin on its surface.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Naoki in view of Ueya as applied to claim 1 above, and further in view of Tsukagoshi et al. (Colloids and Surfaces B: Biointerfaces 54 (2007) 94–100 doi:10.1016/j.colsurfb.2006.10.005) (“Tsukagoshi”).
Regarding claim 24, Naoki in view of Ueya teach the particle of claim 1 as discussed above.
Naoki in view of Ueya suggest that non-specific adsorption of impurities in the sample may result in noise (“and the impurity in the sample are non-specifically adsorbed on the surface of the solid-phase carrier instead of the ligand, which may become noise” para. 2 of Ueya).
Naoki in view of Ueya fail to teach wherein the resin has a unit derived from methoxyethyl (meth)acrylate.
Tsukagoshi teaches “poly(2-methoxyethyl-, 2-(2-methoxyethoxy)ethyl-, 2-[2-(2-methoxyethoxy)ethoxy]ethyl methacrylate) (p(nEOMA), n = 1, 2, and 3) brushed surfaces with varying the polymer density by surface initiated polymerization” (Abstract). Tsukagoshi suggests that a particle having a resin on its surface, the resin having a unit derived from methoxyethyl (meth)acrylate resists nonspecific protein adsorption (“Surface modification of poly(oligoethylene oxide methacrylate) for resisting protein adsorption” Title, “2.3. Substrate preparation Silica particles” page 95 col. 2 para. 2, “We obtained several kinds of p(nEOMA)-modified silica particles” page 97 col. 2 para. 1). Tsukagoshi further teaches that “[s]urfaces that resist the protein adsorption have applications in substrates for enzyme-linked immune assays (ELISAs) and biosensors [1], devices for drug delivery [2], and materials for patterned cell culture” (page 94 col. 1 para. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Naoki in view of Ueya to rely on the resin having a unit derived from methoxyethyl (meth)acrylate taught by Tsukagoshi because Tsukagoshi teaches that this resists nonspecific protein adsorption and Ueya teaches that nonspecific protein adsorption generates noise. A person having ordinary skill in the art would have had a reasonable expectation of success because both Naoki in view of Ueya and Tsukagoshi teach a particle with a resin on its surface for immunoassay applications.
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 1-2, 5, 7-15, 17-19 and 25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 18/329,748 in view of Naoki and Ueya.
Regarding claims 1-2 and 14-15 copending Application No. 18/329,748 recites a particle comprising a magnetic particle containing a magnetic material, wherein the magnetic particle has a resin on a surface (“[a] magnetic particle comprising: a magnetic core particle; and a polymer layer arranged on a surface of the magnetic core particle” claim 1 of copending Application No. 18/329,748) wherein the resin has a functional group capable of binding a ligand, wherein the functional group is carboxyl (“and wherein the polymer layer contains a polymer having at least one kind of functional group…carboxyl” claim 1 of copending Application No. 18/329,748).
Copending Application No. 18/329,748 fails to recite wherein the particle has a volume average particle diameter of 0.7 µm to 0.9 µm, wherein the magnetic material has a particle diameter of at least 0.1 µm, wherein the particle has a density of 5.1 g/cm3 to 10.0 g/cm3, wherein the particle has a density of 5.1 g/cm3 to 6.5 g/cm3, wherein sedimentation speed determined by Stokes' law is 1.0×10-5 (cm/s) or more .
Naoki teaches a particle comprising a magnetic particle containing a magnetic material (para. 1, para. 24, para. 61), wherein the magnetic particle has a resin on a surface (para. 59). Naoki further teaches wherein the particle has a number average particle diameter of 0.7 µm to 0.9 µm (para. 63, paragraphs 53-54), wherein the magnetic material has a particle diameter of at least 0.1 µm (paragraph 61, paragraph 54). Naoki further suggests that when the magnetic material has a particle diameter of at least 0.1 µm, the magnetic trapping property and dispersion stability are satisfactory (“the dispersion particle diameter Dp is 200 to 700 nm, and both the dispersion stability and the magnetic trapping property are practically satisfactory (Dp is this). If it is within the range, there is no practical problem even if D is small). That is, the present invention is characterized by controlling Dp so that both the magnetic trapping property and the dispersion stability can be achieved without any practical problem without special operation when used” para. 54). Naoki further teaches wherein the particle has a density of 5.1 g/cm3 to 10.0 g/cm3, wherein the particle has a density of 5.1 g/cm3 to 6.5 g/cm3 (para. 64), and wherein the resin has a functional group capable of binding a ligand, wherein the functional group capable of binding a ligand is a carboxyl group (“the polymer comprises a combination of carboxyl…” para. 15, “The magnetic marker particles of the present invention are preferably formed by immobilizing “biological substance-binding substance” and / or “biological substance-binding functional group”…. the “biological substance-binding functional group” includes a carboxyl group” para. 76). Naoki further teaches wherein sedimentation speed determined by Stokes' law is 1.0×10-5 (cm/s) or more (para. 17, para. 51 and para. 80).
Ueya teaches “a solid-phase carrier, a ligand-bound solid-phase carrier, a method for detecting or separating a target substance, and a method for producing the solid-phase carrier” (para. 1). Ueya further teaches that “[t]he solid-phase carrier according to the present invention is obtained by bonding a polymer containing a structural unit represented by formula (1) and a structural unit represented by formula (2)” (para. 17), “[t]he polymer preferably forms a polymer brush on the solid-phase carrier surface” (para. 54). Ueya further teaches that in “(Structural Unit (2))” (para. 32) “R is a reactive functional group (carboxy group)…carboxy group is more preferable from a point or the like in which the ligand is easily and quickly bonded to the solid phase carrier” (para. 33). Ueya further teaches that “the form of the solid-phase carrier of the present invention is not particularly limited, and may be any of a particle, …but from the viewpoint of ease of detection or separation of a target substance, particles are preferable, and magnetic particles are more preferable” (para. 56). Ueya further teaches that “[t]he average particle diameter (volume average particle diameter) of the solid phase carrier according to the present invention is preferably 0.1 to 500 μm, more preferably 0.2 to 50 μm, and still more preferably 0.3 to 10 μm…[w]ith such a range, when the solid-phase carrier is a magnetic particle, the magnetism collection speed is increased, the handleability is improved, the ligand binding amount is increased, and the detection sensitivity and the like are improved” (para. 61).
With regards to the claimed range of volume average particle diameter of 0.7 µm to 0.9 µm, the prior art teaches a range of 0.3 µm to 10 µm. In such a case, since there is a substantial overlap of the claimed range and the prior art range, a prima facie case of obviousness exists because it would have been obvious to a person having ordinary skill in the art to arrive at the claimed range by selecting values disclosed within the prior art range. See MPEP 2144.05. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” MPEP 2144.05.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18/329,748 to rely on the magnetic material having a particle diameter of at least 0.1 µm, wherein sedimentation speed determined by Stokes' law is 1.0×10-5 (cm/s) or more taught by Naoki because Naoki suggests that this enables satisfactory magnetic trapping and dispersion stability. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18/329,748 and Naoki teach a magnetic particle with a resin on its surface having a carboxy functional group.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18/329,748 to rely on the volume average particle diameter of .7 µm to 0.9 µm taught by Ueya because Ueya suggests that with such a range, the magnetism collection speed is increase, the handleability is improved, the ligand binding amount is increased, and the detection sensitivity and the like are improved. A person having ordinary skill in the art would have had a reasonable expectation of success given that both copending Application No. 18/329,748 and Ueya teach a magnetic particle with a resin on its surface having a carboxy functional group. Furthermore, copending Application No. 18/329,748 teaches a number average diameter of 0.1 µm or more and 2.0 µm or less.
Regarding claim 5, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 fails to recite wherein the resin has a weight average molecular weight of 10,000 or more.
Ueya teaches wherein the resin has a weight average molecular weight of 10,000 or more (para. 55). Ueya further suggests that this aids in the suppression of non-specific adsorption and the enhancement of the activity of a ligand bound to a solid phase carrier (para. 55).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of copending Application No. 18/329,748 in view of Naoki and Ueya to rely on the resin having a weight average molecular weight of 10,000 or more taught by Ueya because Ueya suggests that this aids in the suppression of non-specific adsorption and the enhancement of the activity of a ligand bound to a solid phase carrier. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18/329,748 and Ueya teach magnetic particles for binding a target substance having a resin on its surface.
Regarding claim 7, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 recites “[t]he magnetic particle according to claim 5, wherein the second polymer layer formed on the first polymer layer and serving as an outermost surface layer of the magnetic particle contains a polymer having a unit derived from glycidyl methacrylate” (claim 7 of copending Application No. 18/329,748).
Copending Application No. 18/329,748 fails to recite wherein the resin has units derived from styrene and acrylic acid.
Naoki further suggest wherein the resin has units derived from styrene and acrylic acid (para. 31).Naoki further suggests that the resin having units derived from styrene and acrylic acid enable dispersion stability of the magnetic particles in a buffer solution (“As a result of intensive studies to solve the above problems, the present inventors have focused on the component composition of the polymer formed on the surface of the magnetic particle and the three-dimensional structure of the particle, thereby dispersibility and dispersion stability in the buffer solution” para. 15).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18/329,748 to rely on the resin has units derived from styrene and acrylic acid taught by Naoki because Naoki suggests that this enables dispersion stability of the magnetic particles in a buffer solution. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18/329,748 and Naoki teach a magnetic particle with a resin on its surface having a carboxy functional group.
Regarding claim 8, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Also, with respect to claim 8, the recitation of “suitable for a specimen test” does not convey any clear structural limitations to the particle itself. As such, the particle of copending Application No. 18/329,748 in view of Naoki and Ueya would also be capable of performing a specimen test. Nonetheless, copending Application No. 18/329,748 recites wherein the particle is used for a specimen test (“[a] particle for an immunological test comprising: the magnetic particle according to claim 1; and a ligand, wherein the ligand and the functional group have a chemical bond therebetween” claim 10 of copending Application No. 18/329,748 “[t]he particle for an immunological test according to claim 10, wherein the ligand is one of an antibody or an antigen” claim 11 of copending Application No. 18/329,748).
Regarding claim 9, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 recites that the particle is used for immunological testing (claims 10-11) and that the magnetic material is made of magnetite and/or maghemite.
Copending Application No. 18/329,748 fails to recite wherein a number of magnetic materials in the magnetic particle is 1, and wherein the magnetic particle contains the magnetic material at a content of 100%.
Naoki suggest wherein a number of magnetic materials in the magnetic particle is 1, and wherein the magnetic particle contains the magnetic material at a content of 100% (para. 61). Naoki further suggests that there is a design incentive to provide magnetic particles with excellent dispersion stability (para. 14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18/329,748 to rely on the number of magnetic materials in the magnetic particle being 1, and wherein the magnetic particle contains the magnetic material at a content of 100% taught by Naoki because both copending Application No. 18/329,748 and Naoki teach particles for immunological testing comprising magnetic material. Given that there is a design incentive to provide magnetic particles with excellent dispersion stability, a person having ordinary skill in the art would have been prompted to vary copending Application No. 18/329,748 particle's magnetic material to be 1 at a 100% content in order to adapt the particle to the design incentives of the immunoassay field of endeavor. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18/329,748 and Naoki teach a magnetic particle with a resin on its surface having a carboxy functional group for immunological testing.
Regarding claims 10-11, copending Application No. 18/329,748 in view of Masuda and Russell address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 recites wherein the magnetic material contains a metal oxide (claim 10) and wherein the magnetic material is iron (claim 11) (“each contain a magnetic iron oxide” claim 2 of copending Application No. 18/329,748). Note that claims 10-11 of the instant application recites the optional limitation “selected from the group consisting of: a metal” (claim 10) and “selected from the group consisting of; nickel; and magnetite” (claim 11), therefore, despite copending Application No. 18/329,748 failing to recite a metal or nickel and magnetite, the recitation of a metal oxide and iron oxide addresses the claim because the claim scope encompasses the exclusion of the optional limitations.
Regarding claims 12-13, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 11 as discussed above.
Copending Application No. 18/329,748 recites wherein the magnetic material contains the iron (claims 2-3 of copending Application No. 18/329,748).
Copending Application No. 18/329,748 fails to recite wherein the magnetic material contains an iron atom at a content of 80% to 100%. Copending Application No. 18/329,748 also fails to recite wherein the magnetic material contains the nickel, and wherein the magnetic material contains a nickel atom at a content of 80% to 100%.
Naoki suggest wherein the magnetic material contains an iron atom at a content of 80% to 100% and wherein the magnetic material contains the nickel, and wherein the magnetic material contains a nickel atom at a content of 80% to 100% (para. 61).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18/329,748 to rely on the magnetic material contains an iron atom at a content of 80% to 100% and wherein the magnetic material contains nickel, and wherein the magnetic material contains a nickel atom at a content of 80% to 100% taught by Naoki for the same reason as discussed above, i.e. known work in one field of endeavor may prompt variations. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18/329,748 and Naoki teach a magnetic particle with a resin on its surface having a carboxy functional group for immunological testing.
Regarding claims 17-18, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 recites an affinity particle comprising the particle of claim 1 and a ligand that binds to the particle (claim 17) and wherein the ligand is an antibody or an antigen (claim 18) (“wherein the functional group is capable of being bonded to a ligand” claim 9 of copending Application No. 18/329,748 “wherein the ligand is one of an antibody or an antigen” claim 11 of copending Application No. 18/329,748).
Regarding claim 19, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 fails to recite a test reagent comprising the affinity particle of claim 17 and a dispersion medium for dispersing the affinity particle.
Naoki teaches a test reagent comprising the affinity particle of claim 17 and a dispersion medium for dispersing the affinity particle (para. 14, para. 21). Naoki further suggests that a dispersion medium enables the application of magnetic particles in various fields such as “quantitative analysis, qualitative analysis, separation and purification of cells, proteins, nucleic acids or other biological substances in the biotechnology field or life science field. Yes. Particularly recently, magnetic particles have been used as markers for detecting a target substance” (para. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18/329,748 to rely on the dispersion medium for dispersing the affinity particle taught by Naoki because Naoki suggests that a dispersion medium enables the application of magnetic particles in various fields such as “quantitative analysis, qualitative analysis, separation and purification of cells, proteins, nucleic acids or other biological substances in the biotechnology field or life science field. Yes. Particularly recently, magnetic particles have been used as markers for detecting a target substance” (para. 2). A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18/329,748 and Naoki teach a magnetic particle with a resin on its surface having a carboxy functional group for immunological testing.
Regarding claim 25, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 in view of Naoki and Ueya further suggest wherein the magnetic material has the particle diameter of at least 0.7 μm (para. 63 of Naoki). Note that although Naoki fails to use the language “the magnetic material has the particle diameter of at least 0.7 μm”, the teaching that the core particle is at least 0.7 μm, (5 nm – 1000 nm) inherently provides the magnetic material having the particle diameter of at least 0.7 μm because the core particle comprises the magnetic material.
Claim 6 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 18/329,748 in view of Naoki and Ueya as applied to claim 1 above, and further in view of Gao and Lu (CN 101178961 A) (hereinafter Gao).
Regarding claim 6, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Ueya further teaches wherein the resin has repeating unit represented by formula (3) (“The solid-phase carrier according to any one of claims 1 to 9, wherein the polymer is a block polymer including a first block constituted by repeating a structural unit represented by the formula (1) and a second block constituted by repeating a structural unit represented by the formula (2)” claim 10, para. 33, see formula 2 of Ueya being analogous to formula (3) of the instant claim).
Copending Application No. 18/329,748 view of Naoki and Ueya fail to teach wherein the resin has repeating unit represented by formula (2).
Gao teaches a “water soluble magnetic nano-crystal” (Abstract) “widely applied to…biological (medical) field,… wherein the application of the biological field, comprising:…cell separation and labeling” (Background Technology paragraph 1). Gao teaches that the magnetic nano-crystal has “its surface…decorated with formed in situ poly N-vinyl pyrrolidone or N-vinyl pyrrolidone copolymer formed with other free radical monomer” (Background Technology paragraph 5). Gao further teaches that “poly N-vinylpyrrolidone (PVP) and monomer N-vinyl pyrrolidone (NVP) not only has excellent solubility, chemical stability, film forming property, low toxicity, physiologically inert, bonding ability and protection function, but also can be combined and various inorganic compounds and organic chemical substance. PVP application in the field of medicine is the vitality of important, physiological soluble PVP has a good, not involved in the metabolism of human body and does not form obvious stimulation to the bodily organ… provides a very good water solubility…[and] good biocompatibility” (Background Technology paragraph 5).
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of copending Application No. 18/329,748 in view of Naoki and Ueya to rely on the resin having repeating units represented by formula (2) taught by Gao because Gao teaches that poly N-vinylpyrrolidone (PVP) has low toxicity, is physiologically inert, has bonding ability and protection function, but also can be combined with various inorganic compounds and organic chemical substances. Gao also motivates a person having ordinary skill in the art to use PVP in the field of medicine because it is biocompatible. A person having ordinary skill in the art would have had a reasonable expectation of success given because Gao teaches that N-vinylpyrrolidone (PVP) has excellent solubility, chemical stability and film-forming property.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 18329748 in view of Naoki and Ueya as applied to claim 1 above, and further in view of Usuki.
Regarding claim 16, copending Application No. 18/329,748 in view of Naoki and Ueya address the particle of claim 1 as discussed above.
Copending Application No. 18/329,748 in view of Naoki and Ueya fail to recite wherein the resin has a siloxane bond.
Usuki teaches wherein the resin has a siloxane bond (paragraph 49, paragraph 94). Usuki further teaches that the siloxane bond “is effective for providing the coating polymer on the surfaces of the particles” (paragraph 69).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of copending Application No. 18/329,748 in view of Naoki and Ueya to rely on the resin having a siloxane bond taught by Usuki because Usuki teaches that “[t]his is effective for providing the coating polymer on the surfaces of the particles” (paragraph 69). A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18329748 in view of Naoki and Ueya and Usuki teach particles for binding a target substance having a resin on its surface.
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-11 of copending Application No. 18329748 in view of Naoki and Ueya as applied to claim 1 above, and further in view of Tsukagoshi.
Regarding claim 24, copending Application No. 18329748 in view of Naoki and Ueya teach the particle of claim 1 as discussed above.
Copending Application No. 18329748 in view of Naoki and Ueya suggest that non-specific adsorption of impurities in the sample may result in noise (“and the impurity in the sample are non-specifically adsorbed on the surface of the solid-phase carrier instead of the ligand, which may become noise” para. 2 of Ueya).
Copending Application No. 18329748 in view of Naoki and Ueya fail to teach wherein the resin has a unit derived from methoxyethyl (meth)acrylate.
Tsukagoshi teaches “poly(2-methoxyethyl-, 2-(2-methoxyethoxy)ethyl-, 2-[2-(2-methoxyethoxy)ethoxy]ethyl methacrylate) (p(nEOMA), n = 1, 2, and 3) brushed surfaces with varying the polymer density by surface initiated polymerization” (Abstract). Tsukagoshi suggests that a particle having a resin on its surface, the resin having a unit derived from methoxyethyl (meth)acrylate resists nonspecific protein adsorption (“Surface modification of poly(oligoethylene oxide methacrylate) for resisting protein adsorption” Title, “2.3. Substrate preparation Silica particles” page 95 col. 2 para. 2, “We obtained several kinds of p(nEOMA)-modified silica particles” page 97 col. 2 para. 1). Tsukagoshi further teaches that “[s]urfaces that resist the protein adsorption have applications in substrates for enzyme-linked immune assays (ELISAs) and biosensors [1], devices for drug delivery [2], and materials for patterned cell culture” (page 94 col. 1 para. 1).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of copending Application No. 18/329,748 in view of Naoki and Ueya to rely on the resin having a unit derived from methoxyethyl (meth)acrylate taught by Tsukagoshi because Tsukagoshi teaches that this resists nonspecific protein adsorption and Ueya teaches that nonspecific protein adsorption generates noise. A person having ordinary skill in the art would have had a reasonable expectation of success because both copending Application No. 18/329,748 in view of Naoki and Ueya and Tsukagoshi teach a particle with a resin on its surface for immunoassay applications.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 1/13/2026 have been fully considered but they are not persuasive.
Applicant argues that “Naoki fails to disclose or suggest, inter alia, the sedimentation speed as claimed. While Naoki mentions sedimentation-related indices (e.g., VB, V') as parameters for evaluating dispersion stability, these indices are uniquely defined based on sedimentation behavior under centrifugal force and are different from the claimed sedimentation speed” (page 9 para. 4). However, contrary to Applicant’s remark, the sedimentation-related indices (e.g., VB, V’) taught by Naoki are based on static conditions, without any centrifugal force (“Here, the sedimentation velocity VB represented by Equation 1, which will be described in detail later, can be equated with the so-called "sedimentation velocity of dispersed particles in a buffer solution under static conditions"” para. 51, “Therefore, in the following formula 1, the dispersion stability is evaluated in consideration of eliminating the influence of the centrifugal force. VB = Vs / A….(1)…By using Equation 1, a value independent of the centrifugal force is obtained, and the dispersion stability of the magnetic marker particles in the buffer solution can be directly compared” para. 80). Applicant further argues that “the sedimentation speed (V') in the Examples in Naoki when no centrifugal force is applied is reported to be l.06-7.56x10-5 (μm/s) (Naoki, Table 2). These values are orders of magnitude less than the claimed sedimentation speed determined by Stokes' law of at least 1.0x 10-5 ( cm/s )” page 10 para. 1). However, l.06-7.56x10-5 (μm/s) is a velocity that is at least 1.0x 10-5 ( cm/s ), not orders or magnitude less. Applicant further argues that “Naoki is not concerned with providing particle collection with sedimentation toward the bottom of the container, which differentiates its detection concept from that of the present invention” (page 10 para. 2). However, the claims are not limited to providing particle collection with sedimentation toward the bottom of the container. Applicant further argues that “Naoki fails to teach inherently that the particle size of the magnetic material is at least 0.1 μm… while the primary particle diameter in Example 1 of Naoki is 24 nm, the DLS dispersion diameter is 154.3 nm, and the experimental data demonstrate that Dp can be significantly larger than D, as can be found in paragraphs [0121] to [0124] of Naoki. Accordingly, Dp of 0.1 μm or more does not mean that the core particle diameter ( or the particle diameter of the magnetic material) is necessarily (inherently) 0.1 μm or more” (page 11 paras. 2-3). However, contrary to Applicant’s remark, Naoki teaches a core particle of at least 0.1 μm or more (see rejection above). Applicant further argues that “Naoki, Ueya, Gao, Usuki, and Tsukagoshi, whether considered separately or in any permissible combination, do not disclose or suggest the presently claimed invention”(page 12 para. 3). However, Naoki in view of Ueya teach the particle of claim 1 as discussed above (see rejection above). Regarding the nonstatutory double patenting rejection, Applicant argues that “Naoki and Ueya fail to teach a particle with the claimed parameters, even if taken together with Gao, Usuki, and Tsukagoshi, at least for the reasons discussed above” (page 12 para. 5). However, copending application 18/329,748 in view of Naoki and Ueya address claim 1 as discussed above (see rejection above). Applicant further argues that “the present application has an earlier patent term filing date than the '748 application. Thus, in accordance with M.P.E.P. § 804(l)(b)(i), the provisional double patent rejection should be withdrawn” (page 12 para. 1). However, M.P.E.P. § 804(l)(b)(i) requires that the “provisional nonstatutory double patenting rejection [be] the only rejection remaining”. Given that the 103 rejections are maintained, the provisional double patenting rejections are also maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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 FERNANDO IVICH whose telephone number is (703)756-5386. The examiner can normally be reached M-F 9:30-6:00 (E.T.).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory S. Emch can be reached at (571) 272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Fernando Ivich/Examiner, Art Unit 1678
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677