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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation “The composition according to claim 6, wherein the composition is used for a reverse transcription polymerase chain reaction method” in lines 1-2, which is indefinite because it is unclear how “wherein the composition is used for a reverse transcription polymerase chain reaction method” limits the composition and/or structure of “The composition according to claim 6”. It is also unclear if the applicant is claiming a method of using the composition according to claim 6 for a reverse transcription polymerase chain reaction method, and if the applicant is claiming a method, the steps for performing the method are unclear. For further examination of the claims, this limitation is interpreted as “The composition according to claim 6, wherein the composition is for a reverse transcription polymerase chain reaction method”.
Claim 8 recites the limitation “The composition according to claim 6, wherein the composition is used for a quantitative polymerase chain reaction method” in lines 1-2, which is indefinite because it is unclear how “wherein the composition is used for a quantitative polymerase chain reaction method” limits the composition and/or structure of “The composition according to claim 6”. It is also unclear if the applicant is claiming a method of using the composition according to claim 6 for a quantitative polymerase chain reaction method, and if the applicant is claiming a method, the steps for performing the method are unclear. For further examination of the claims, this limitation is interpreted as “The composition according to claim 6, wherein the composition is for a quantitative polymerase chain reaction method”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 4, 6-10, 14, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ko et al. (US 2019/0360021 A1, cited in IDS).
Regarding claim 1, Ko teaches a 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent that is present in a composition for a polymerase reaction [0010] that is a polymerase chain reaction [0013], which reads on a sensitizer for nucleic acid amplification, which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having 1 carbon atom as claimed.
Regarding claim 3, Ko teaches that the 2-methacryloyloxyethyl phosphorylcholine (MPC)- containing zwitterionic copolymer [0010] includes a zwitterionic 2-methacyrloxyethyl phosphorylcholine (MPC) unit and an alkyl methacrylate-based monomer unit functionalized by a cationic, an anionic, or a hydrophobic functional group [0011], wherein the alkyl methacrylate-based monomer unit is methyl methacrylate, ethyl methacrylate, n-butyl methacrylate, butyl methacrylate, pentyl methacrylate, hexyl methacrylate, heptyl methacrylate, octyl methacrylate, or tridecyl methacrylate [0036], which reads on wherein the sensitizer is a copolymer further comprising a constitutional unit derived from a monomer represented by the formula (2) wherein R4 is a methyl group, and R5 is an alkyl group having 1, 2, 4 to 8, or 13 carbon atoms as claimed.
Regarding claim 4, Ko teaches that the 2-methacryloyloxyethyl phosphorylcholine (MPC)- containing zwitterionic copolymer [0010] includes a zwitterionic 2-methacyrloxyethyl phosphorylcholine (MPC) unit and an alkyl methacrylate-based monomer unit functionalized by a cationic, an anionic, or a hydrophobic functional group [0011], wherein the alkyl methacrylate-based monomer unit is tridecyl methacrylate [0036], which reads on wherein R5 is an alkyl group having 13 carbon atoms as claimed.
Regarding claims 6 and 14, Ko teaches a composition for a polymerase reaction including a 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent [0010], wherein the polymerase reaction is a polymerase chain reaction [0013], which reads on a composition for nucleic acid amplification comprising the sensitizer according to claim 1 as claimed, and on a composition for nucleic acid amplification, comprising the sensitizer according to claim 3 as claimed.
Regarding claim 7, Ko teaches that the composition for a polymerase reaction may be used for application to reverse transcription PCR [0050], wherein PCR is polymerase chain reaction [0002], which reads on wherein the composition is used for a reverse transcription polymerase chain reaction method as claimed.
Regarding claim 8, Ko teaches that the composition for a polymerase reaction may be used for quantitative fluorescent PCR or quantitative fluorescent PCR [0050], wherein PCR is polymerase chain reaction [0002], which reads on wherein the composition is used for a quantitative polymerase chain reaction method as claimed.
Regarding claims 9, 10, and 15, Ko teaches a kit including a composition for a polymerase reaction including a 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent [0053], wherein the kit is a PCR kit and further includes a reducing agent, a buffer, a mixture of dNTP, an instruction for use of the composition, and other components required for a thermal cycling reaction to amplify a nucleic acid, wherein the kit also includes a sample containing a predefined target nucleic acid which is used in a control group reaction, wherein the kit includes a stock solution, buffer, enzyme, detectable label or reagent, required for detection, tube, and membrane [0054], which reads on a test kit comprising the composition according to claim 6 as claimed, wherein the test kit is for a clinical test as claimed, and on a test kid comprising the composition according to claim 14 as claimed. Ko satisfies the limitation wherein the test kit is for a clinical test as claimed also because Ko teaches all of the claimed ingredients, amounts, process steps, and process conditions of the test kit, which means that Ko’s test kit would have been suitable for a clinical test.
Claims 1, 2, 6-8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaneko (US 2018/0369804 A1).
Regarding claims 1 and 2, Kaneko teaches 2-methacryloyloxyethylphosphorylcholine polymer that is used as a material that is used in a cell low-attachment treatment [0056], wherein the inside of a container for PCR is coated with the material, wherein cell low-attachment treatment prevents cells, that is, protein from attaching to the inside of the container for PCR, and the material does not absorb protein [0055], where in a case in which the which the cell low-attachment treatment is carried out on the inside of the container for PCR, it is possible to prevent the cell from attaching to the inner wall of the container for PCR, reliably make the cell reach the bottom surface, and enable the observation of the cell [0057], wherein PCR is polymerase chain reaction [0004], which reads on a sensitizer for nucleic acid amplification which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having 1 carbon atom as claimed, wherein the sensitizer is a homopolymer comprising one kind of constitutional unit derived from the monomer represented by the formula (1) as claimed.
Regarding claims 6 and 12, Kaneko teaches a dispersion liquid obtained by dispersing a material that is a 2-methacryloyloxyethylphosphorylcholine polymer in a solvent, wherein the dispersion liquid is used in a coating method in which a surface is coated by dipping the surface in the dispersion liquid and then drying the surface [0056], wherein the surface is the inside of a container for PCR, wherein the treatment is a cell low-attachment treatment that prevents cells, that is, protein from attaching to the inside of the container for PCR, and the material does not absorb protein [0055], where in a case in which the which the cell low-attachment treatment is carried out on the inside of the container for PCR, it is possible to prevent the cell from attaching to the inner wall of the container for PCR, reliably make the cell reach the bottom surface, and enable the observation of the cell [0057], wherein PCR is polymerase chain reaction [0004], which reads on a composition for nucleic acid amplification, comprising the sensitizer according to claim 1 as claimed, and on a composition for nucleic acid amplification, comprising the sensitizer according to claim 2 as claimed.
Regarding claim 7, Kaneko satisfies the limitation wherein the composition is used for a reverse transcription polymerase chain reaction method as claimed because Kaneko teaches all of the claimed ingredients, amounts, process steps, and process conditions of the composition according to claim 6, which means that Kaneko’s composition must be able to be used for a reverse transcription polymerase chain reaction method.
Regarding claim 8, Kaneko satisfies the limitation wherein the composition is used for a quantitative polymerase chain reaction method as claimed because Kaneko teaches all of the claimed ingredients, amounts, process steps, and process conditions of the composition according to claim 6, which means that Kaneko’s composition must be able to be used for a quantitative polymerase chain reaction method.
Claims 1, 3-8, 14, 16, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sakaki et al. (JP 2006-305401 A, machine translation in English used for citation).
Regarding claim 1, Sakaki teaches a terpolymer of 2-(meth)acryloyloxyethyl phosphorylcholine, glycerol mono(meth)acrylate, and alkyl(meth)acrylate (Sakaki claim 4), or copolymers obtained by copolymerizing a hydrophobic monomer with 2-(meth)acryloyloxyethyl phosphorylcholine [0011], or terpolymers of a hydroxyl group-containing monomer, a hydrophobic monomer, and 2-(meth)acryloyloxyethyl phosphorylcholine [0011], wherein examples of hydrophobic monomers include methyl (meth)acrylate, ethyl (meth)acrylate, butyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, lauryl (meth)acrylate, and stearyl (meth)acrylate [0012], and/or wherein the hydroxyl group-containing monomer is glycerol (meth)acrylate [0013], which reads on a polymer comprising a constitutional unit derived from a monomer represented by the formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having1 carbon atom as claimed. Sakaki satisfies the limitation wherein the polymer is a sensitizer for nucleic acid amplification because Sakaki teaches all of the claimed ingredients, amounts, process steps, and process conditions of the polymer, which means that Sakak’s polymer must be a sensitizer for nucleic acid amplification as claimed. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (MPEP 2112.01(I)). "Products of identical chemical composition cannot have mutually exclusive properties (MPEP 2112.01(II))." A chemical composition and its properties are inseparable (MPEP 2112.01(II)). Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (MPEP 2112.01(II)).
Regarding claim 3, Sakaki teaches copolymers obtained by copolymerizing a hydrophobic monomer with 2-(meth)acryloyloxyethyl phosphorylcholine [0011], or terpolymers of a hydroxyl group-containing monomer, a hydrophobic monomer, and 2-(meth)acryloyloxyethyl phosphorylcholine [0011], or a copolymer of a combination of monomers that is a combination of MPC-butyl methacrylate-GLM, wherein GLM is glycerol methacrylate [0013], and MPC is 2-(meth)acryloyloxyethyl phosphorylcholine [0004, 0014], wherein examples of hydrophobic monomers include methyl (meth)acrylate, ethyl (meth)acrylate, butyl (meth)acrylate, 2-ethylhexyl (meth)acrylate, lauryl (meth)acrylate, and stearyl (meth)acrylate [0012], which reads on wherein the sensitizer is a copolymer further comprising a constitutional unit derived from a monomer represented by the formula (2) wherein R4 is a hydrogen atom or a methyl group, and R5 is an alkyl group having 1, 2, 4, 8, 12, or 18 carbon atoms as claimed.
Regarding claim 4, Sakaki teaches copolymers obtained by copolymerizing a hydrophobic monomer with 2-(meth)acryloyloxyethyl phosphorylcholine [0011], or terpolymers of a hydroxyl group-containing monomer, a hydrophobic monomer, and 2-(meth)acryloyloxyethyl phosphorylcholine [0011], wherein examples of hydrophobic monomers include lauryl (meth)acrylate, and stearyl (meth)acrylate [0012], which reads on wherein R5 is an alkyl group having 12 or 18 carbon atoms as claimed.
Regarding claim 5, Sakaki teaches a terpolymer of 2-(meth)acryloyloxyethyl phosphorylcholine, glycerol mono(meth)acrylate, and alkyl(meth)acrylate (Sakaki claim 4), or terpolymers of a hydroxyl group-containing monomer, a hydrophobic monomer, and 2-(meth)acryloyloxyethyl phosphorylcholine [0011], wherein the hydroxyl group-containing monomer is glycerol (meth)acrylate [0013], which reads on wherein the sensitizer is a copolymer further comprising a constitutional unit derived from a monomer represented by the formula (3) wherein R6 is a hydrogen atom or a methyl group, and R7 is an alkyl having 3 carbon atoms, and two hydroxy groups as claimed.
Regarding claim 6, Sakaki teaches that the terpolymer of 2-(meth)acryloyloxyethyl phosphorylcholine, glycerol mono(meth)acrylate, and alkyl(meth)acrylate (Sakaki claim 4) is present in a gas-purifier further comprising an enzyme and water (Sakaki claim 1), and that the copolymers obtained by copolymerizing a hydrophobic monomer with 2-(meth)acryloyloxyethyl phosphorylcholine or the terpolymers of a hydroxyl group-containing monomer, a hydrophobic monomer, and 2-(meth)acryloyloxyethyl phosphorylcholine are a 2-(meth)acryloyloxyethyl phosphorylcholine-containing polymer [0011] that is present in a gas phase purifier that further contains an enzyme and water [0009], which reads on a composition comprising the sensitizer according to claim 1. The limitation wherein the composition is a composition for nucleic acid amplification is an intended use. Sakaki’s composition would have been capable of performing as a composition for nucleic acid amplification as claimed because Sakai teaches all of the claimed ingredients, amounts, process steps, and process conditions of the composition for nucleic acid amplification. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim (MPEP 2111.02(II)).
Regarding claim 7, Sakaki satisfies the limitation wherein the composition is used for a reverse transcription polymerase chain reaction method as claimed because Sakaki teaches all of the claimed ingredients, amounts, process steps, and process conditions of the composition according to claim 6 as explained above, and Sakaki’s composition therefore would have been capable of being used for a reverse transcription polymerase chain reaction method. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (MPEP 2112.01(I)). "Products of identical chemical composition cannot have mutually exclusive properties (MPEP 2112.01(II))." A chemical composition and its properties are inseparable (MPEP 2112.01(II)). Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (MPEP 2112.01(II)).
Regarding claim 8, Sakaki satisfies the limitation wherein the composition is used for a quantitative polymerase chain reaction method as claimed because Sakaki teaches all of the claimed ingredients, amounts, process steps, and process conditions of the composition according to claim 6 as explained above, and Sakaki’s composition therefore would have been capable of being used for a quantitative polymerase chain reaction method. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established (MPEP 2112.01(I)). "Products of identical chemical composition cannot have mutually exclusive properties (MPEP 2112.01(II))." A chemical composition and its properties are inseparable (MPEP 2112.01(II)). Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (MPEP 2112.01(II)).
Regarding claim 14, Sakaki teaches that the copolymers obtained by copolymerizing a hydrophobic monomer with 2-(meth)acryloyloxyethyl phosphorylcholine or the terpolymers of a hydroxyl group-containing monomer, a hydrophobic monomer, and 2-(meth)acryloyloxyethyl phosphorylcholine are a 2-(meth)acryloyloxyethyl phosphorylcholine-containing polymer [0011] that is present in a gas phase purifier that further contains an enzyme and water [0009], which reads on a composition comprising the sensitizer according to claim 3. The limitation wherein the composition is a composition for nucleic acid amplification is an intended use. Sakaki’s composition would have been capable of performing as a composition for nucleic acid amplification as claimed because Sakai teaches all of the claimed ingredients, amounts, process steps, and process conditions of the composition for nucleic acid amplification. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim (MPEP 2111.02(II)).
Regarding claim 16, Sakaki teaches a copolymer of a combination of monomers that is a combination of MPC-butyl methacrylate-GLM, wherein GLM is glycerol methacrylate [0013], and MPC is 2-(meth)acryloyloxyethyl phosphorylcholine [0004, 0014], which reads on wherein the sensitizer is a copolymer further comprising a constitutional unit derived from a monomer represented by the formula (3) wherein R6 is a methyl group, and R7 is an alkyl group having 3 carbon atoms, and two hydroxy groups as claimed.
Regarding claim 17, Sakaki teaches that the copolymer of a combination of monomers that is a combination of MPC-butyl methacrylate-GLM [0013] is a 2-(meth)acryloyloxyethyl phosphorylcholine-containing polymer [0011] that is present in a gas phase purifier that further contains an enzyme and water [0009], which reads on a composition comprising the sensitizer according to claim 16. The limitation wherein the composition is a composition for nucleic acid amplification is an intended use. Sakaki’s composition would have been capable of performing as a composition for nucleic acid amplification as claimed because Sakai teaches all of the claimed ingredients, amounts, process steps, and process conditions of the composition for nucleic acid amplification. To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim (MPEP 2111.02(II)).
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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 2, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ko et al. (US 2019/0360021 A1, cited in IDS) as applied to claim 1 and further in view of Kaneko (US 2018/0369804 A1).
Regarding claims 2 and 12, Ko teaches the sensitizer according to claim 1 as explained above. Ko teaches a 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent that is present in a composition for a polymerase reaction [0010] that is a polymerase chain reaction [0013], which reads on a composition for nucleic acid amplification.
Ko does not teach that the sensitizer is a homopolymer comprising one kind of constitutional unit derived from the monomer represented by the formula (1), and does not teach that the composition for nucleic acid amplification comprises the sensitizer according to claim 2. However, Kaneko teaches 2-methacryloyloxyethylphosphorylcholine polymer that is used as a material that is used in a cell low-attachment treatment [0056], wherein the inside of a container for PCR is coated with the material, wherein cell low-attachment treatment prevents cells, that is, protein from attaching to the inside of the container for PCR, and the material does not absorb protein [0055], where in a case in which the which the cell low-attachment treatment is carried out on the inside of the container for PCR, it is possible to prevent the cell from attaching to the inner wall of the container for PCR, reliably make the cell reach the bottom surface, and enable the observation of the cell [0057], wherein PCR is polymerase chain reaction [0004]. Ko and Kaneko are analogous art because both references are in the same field of endeavor of a sensitizer for nucleic acid amplification which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1). Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to use Kaneko’s 2-methacryloyloxyethylphosphorylcholine polymer to substitute for a fraction of Ko’s 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent in Ko’s composition. The proposed modification would read on wherein the sensitizer is a homopolymer comprising one kind of constitutional unit derived from the monomer represented by the formula (1) as claimed, and on the composition for nucleic acid amplification comprising the sensitizer according to claim 2 as claimed. One of ordinary skill in the art would have been motivated to do so because Kaneko teaches that the 2-methacryloyloxyethylphosphorylcholine polymer is a material that is beneficial for being a cell low-attachment treatment [0056] when the inside of a container for PCR is coated with the material, is beneficial for preventing cells, that is, protein from attaching to the inside of the container for PCR when the inside of the container is coated with the material, is beneficial for not absorbing protein [0055], and is beneficial for preventing a cell from attaching to the inner wall of a container for PCR [0057], and that PCR is polymerase chain reaction [0004], which would have been desirable for Ko’s composition because Ko teaches that the composition for a polymerase reaction comprises a 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent [0010], and that the polymerase reaction is a polymerase chain reaction [0013].
Regarding claim 13, Ko teaches a kit including the composition for a polymerase reaction including the 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent [0053], wherein the kit is a PCR kit and further includes a reducing agent, a buffer, a mixture of dNTP, an instruction for use of the composition, and other components required for a thermal cycling reaction to amplify a nucleic acid, wherein the kit also includes a sample containing a predefined target nucleic acid which is used in a control group reaction, wherein the kit includes a stock solution, buffer, enzyme, detectable label or reagent, required for detection, tube, and membrane [0054], which reads on a test kit comprising the composition according to claim 12 as claimed.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ko et al. (US 2019/0360021 A1, cited in IDS) as applied to claim 9, and further in view of Saito (JP 2010-207180 A, cited in IDS, machine translation in English used for citation, made of record on 12/03/2024).
Regarding claim 11, Ko teaches the test kit according to claim 9 as explained above. Ko teaches that the kit may also optionally include a detectable label or reagent, required for detection [0054].
Ko does not teach that an object of the test is a virus. However, Saito teaches a method for detecting norovirus RNA comprising amplifying norovirus RNA purified by a method for purifying norovirus RNA by a nucleic acid amplification reaction, and detecting norovirus by detecting the amplified nucleic acid, wherein the norovirus RNA is purified in a reaction vessel for purifying norovirus RNA, wherein the reaction vessel comprises a carrier, wherein the reaction vessel has, on a surface of the carrier, a polymer substance containing a first unit having a group derived from a phosphoric acid ester constituting a hydrophilic portion of a phospholipid and a second unit having a carboxylic acid-derived group [0008], wherein the first unit is a (meth)acryloyloxyalkylphosphorylcholine group [0012]. Ko and Saito are analogous art because both references are in the same field of endeavor of a sensitizer of nucleic acid amplification which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1). Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to use Saito’s norovirus RNA as the detectable label or reagent in Ko’s kit. The proposed modification would read on wherein an object of the test is a virus as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for providing a detectable label or reagent for Ko’s kit and/or for providing Ko’s kit with the ability to detect a norovirus RNA because Saito teaches a method for detecting norovirus RNA comprising amplifying norovirus RNA purified by a method for purifying norovirus RNA by a nucleic acid amplification reaction, and detecting norovirus by detecting the amplified nucleic acid, wherein the norovirus RNA is purified in a reaction vessel for purifying norovirus RNA, wherein the reaction vessel comprises a carrier, wherein the reaction vessel has, on a surface of the carrier, a polymer substance containing a first unit having a group derived from a phosphoric acid ester constituting a hydrophilic portion of a phospholipid and a second unit having a carboxylic acid-derived group [0008], wherein the first unit is a (meth)acryloyloxyalkylphosphorylcholine group [0012], and because Ko teaches that the kit may also optionally include a detectable label or reagent, required for detection [0054], that a kit includes a composition for a polymerase reaction including a 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent [0053], that wherein the kit is a PCR kit and further includes a reducing agent, a buffer, a mixture of dNTP, an instruction for use of the composition, and other components required for a thermal cycling reaction to amplify a nucleic acid, that the kit also includes a sample containing a predefined target nucleic acid which is used in a control group reaction, and that the kit includes a stock solution, buffer, enzyme, detectable label or reagent, required for detection, tube, and membrane [0054].
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 1-8, 12, 14, 16, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, and 7 of copending Application No. 19/130,695 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a dry composition for nucleic acid amplification, comprising a polymer containing a constitutional unit derived from a monomer represented by the formula (1) [Chem. 1]
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wherein X1 is a (meth)acryloyloxy group or a (meth)acryloylamino group, L1 is an alkylene group having 2 to 4 carbon atoms and optionally having one hydroxy group, and R1 to R3 are each independently an alkyl group having 1 to 3 carbon atoms (claim 1), which reads on a sensitizer for nucleic acid amplification which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having 1 carbon atom as claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-8, 12, 14, 16, and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/697,245 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a nucleic acid amplification-promoting agent consisting of a polymer comprising a constitutional unit derived from a monomer having a phosphorylcholine group (claim 1), wherein the polymer comprises one or more polymers selected from the following group a: [group a] (a-1) a polymer comprising a constitutional unit derived from 2-(meth)acryloyloxyethylphosphorylcholine alone, (a-2) a copolymer comprising a constitutional unit derived from 2-(meth)acryloyloxyethylphosphorylcholine and a constitutional unit derived from (meth)acrylic acid, (a-3) a copolymer comprising a constitutional unit derived from 2-(meth)acryloyloxyethylphosphorylcholine and a constitutional unit derived from a C2-C20 alkyl (meth)acrylate, (a-4) a copolymer comprising a constitutional unit derived from 2-(meth)acryloyloxyethylphosphorylcholine, a constitutional unit derived from a C2-C8 alkyl (meth)acrylate, and a constitutional unit derived from a C2-C8 alkyl (meth)acrylate having two or more hydroxy groups as substituents, and (a-5) a copolymer comprising a constitutional unit derived from a 2-(meth)acryloyloxyethylphosphorylcholine and a constitutional unit derived from a polyethylene glycol (meth)arylate (claim 2), which reads on a sensitizer for nucleic acid amplification which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having 1 carbon atom as claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-3, 6-8, 12, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/458,354 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims a method for improving repeatability of a nucleic acid amplification method, comprising performing a nucleic acid amplification reaction using a reaction composition comprising water, an amplification target nucleic acid at a concentration of not more than 10,000 copies/mL, and one or more polymers selected from the following group A at a concentration of 0.005 to 0.5 w/v%:[group A](Al) a polymer consisting of a constitutional unit derived from 2-(meth)acryloyloxyethylphosphorylcholine (A2) a copolymer containing a constitutional unit derived from 2-(meth)acryloyloxyethylphosphorylcholine and a constitutional unit derived from (meth)acrylic acid (claim 1), which reads on a sensitizer for nucleic acid amplification which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having 1 carbon atom as claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 4, 6-8, and 14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of U.S. Patent No. 8,252,531 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a method of clinical analysis comprising the steps of: (1) contacting a sample containing a specific nucleic substance with a test agent capable of hybridizing with said specific nucleic substance in the presence of polymer (H) having a nonspecific hybridization inhibitory action in an amount of 0.0001 to 20 wt % of a hybridization system, under particular conditions for hybridizing said specific nucleic substance with said test agent, and specifically hybridizing said nucleic substance with said test agent, while said polymer (H) inhibits nonspecific hybridization, wherein said polymer (H) has a weight average molecular weight of 1000 to 5000000 and has a group derived from a monomer having a phosphorylcholine-like group represented by the formula (1), and (2) detecting a reactant generated by hybridization of said specific nucleic substance with said test agent in step (1) (claim 1), wherein said polymer (H) is a polymer obtained by polymerization of a monomer composition comprising 5 to 90 mol % of said monomer having a phosphorylcholine-like group represented by the formula (1), 5 to 90 mol % of at least one of a monomer having a carboxyl group and a monomer having a sulfone group, and 5 to 60 mol % of a hydrophobic monomer (claim 2), wherein said monomer having a phosphorylcholine-like group represented by the formula (1) is 2-((meth)acryloyloxy)ethyl-2'-(trimethylammonio)ethyl phosphate, said monomer having a carboxyl group is (meth)acrylic acid, said monomer having a sulfone group is 2-methylpropane sulfonate, and said hydrophobic monomer is a monomer represented by the formula (2):
PNG
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112
156
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Greyscale
wherein R6 stands for a hydrogen atom or a methyl group, L1 stands for
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22
142
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, and L2 stands for a hydrogen atom,
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28
130
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, wherein g each denotes an integer of 1 to 24, and L3 stands for a hydrogen atom, or a methyl group (claim 3), which reads on a sensitizer for nucleic acid amplification which is a polymer comprising a constitutional unit derived from a monomer represented by the formula (1) wherein X1 is a (meth)acryloyloxy group, L1 is an alkylene group having 2 carbon atoms, and R1 to R3 are each independently an alkyl group having 1 carbon atom as claimed.
Allowable Subject Matter
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 18, Sakaki et al. (JP 2006-305401 A, machine translation in English used for citation) teaches the composition according to claim 17 as explained above.
Sakaki does not teach a test kit comprising the composition according to claim 17. Although Ko et al. (US 2019/0360021 A1, cited in IDS) teaches a kit including a composition for a polymerase reaction including a 2-methacryloyloxyethyl phosphorylcholine (MPC)-containing zwitterionic copolymer detergent [0053], wherein the kit is a PCR kit [0054], Ko does not teach or suggest using the composition according to claim 17 in the kit because Ko does not teach the sensitizer according to claim 16. Also, Sakaki, Ko, and the prior art of record do not teach or suggest any benefits or advantages to using Sakaki’s composition in a test kit. Sakaki teaches that their composition is a gas phase purifier that contains an enzyme, water [0009], and a 2-(meth)acryloyloxyethyl phosphorylcholine-containing polymer [0011] that is a copolymer of a combination of monomers that is a combination of MPC-butyl methacrylate-GLM [0013], and the prior art of record do not teach or suggest any benefits or advantages to using a gas phase purifier in a test kit. Furthermore, the prior art of record do not teach or suggest a test kit comprising the composition according to claim 17.
Correspondence
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/DAVID T KARST/Primary Examiner, Art Unit 1767