DETAILED ACTION
This is in response to communication of 4/30/26.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of AIA 35 U.S.C. code not present in this action can be found in previous office actions dated 2/4/25, 6/6/25 and 12/8/25
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/30/26 has been entered.
Claim Rejections - 35 USC § 103
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Kohama et al. US PGPub 2017/0258966 hereinafter KOHAMA in view of Ochiai et al. US PGPub 2012/0024779 hereinafter OCHIAI on claims 1, 3-8, 15-16, 18 and 21 are maintained. The rejection is updated below to meet the added claim limitations. The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Kohama et al. US PGPub 2017/0258966 hereinafter KOHAMA in view of Ochiai et al. US PGPub 2012/0024779 hereinafter OCHIAI on claims 2 and 17 are withdrawn because the claims have been cancelled.
As for claim 1, KOHAMA teaches "According to the above configuration, a medical device including a lubrication layer (coating layer) that exhibits excellent lubricity and durability, and a method for producing the medical device are provided" (paragraph 17) and "Among the materials for forming the base layer 1, the metal material is not particularly limited and a metal material that is generally used for a medical device, such as a catheter, a guidewire, and an indwelling needle may be used" (Paragraph 30, lines 1-5), i.e. A method for manufacturing a medical instrument that includes a base layer and that is configured to be positioned in a lumen or cavity in a living body.
KOHAMA teaches "A method for producing the medical device as set forth in claim 1, comprising: dissolving the block copolymer (A) and the polymer (B) in a solvent to prepare a mixture liquid; coating at least a part of the base layer with the mixture liquid; and thereafter, crosslinking or polymerizing the block copolymer (A) in the absence of a catalyst to thereby form a mesh structure on the base layer" (claim 9), i.e. applying a solution onto the base layer of the medical instrument to provide a lubricating coating layer on the medical instrument that facilitates sliding of the medical instrument in the living body when the medical instrument is brought into contact with fluid in the living body, the solution that is applied onto the base layer comprising: a block copolymer having a structural unit (A) ... and a structural unit (B) ... and a solvent to form the lubricating layer.
KOHAMA teaches "The reactive monomer composing the block copolymer (A) has an epoxy group as a reactive group" (paragraph 41, lines 1-2), i.e. structural unit (A) derived from a reactive monomer having an epoxy group.
KOHAMA teaches "The hydrophilic monomer(constituting unit (A-2')) composing the polymer (B)" (paragraph 44, line 1), i.e. a structural unit (B) derived from a hydrophilic monomer.
KOHAMA is silent on a choline derivative.
OCHIAI teaches “According to the above-mentioned particular structure, making use of the copolymer that comprises a monomer (A), a monomer (B) and a monomer (C) having a specified structure as monomer components” (paragraph 19, lines 1-4) and “The monomer (B) having a basic functional group, which is a monomer component of the copolymer, may be any monomer which can copolymerize with the monomer (A) in a specific molar ratio” (paragraph 40, lines 1-4).
OCHIAI teaches "It is preferred that the monomer (B) is at least one monomer selected from the monomers of formulae (3), (4), (5) and (6) below, respectively" (paragraph 41; emphasis added). OCHIAI teaches the following chemical formula after paragraph 41:
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OCHIAI teaches "(wherein (R5)s represent a hydrogen or a methyl group, (R6)s independently represent. .. an alkyl group having 1 ... carbon atoms respectively, n represents an integer of 2 to 4, and (X-)s represent an anion derived from halogen" (paragraph 42), i.e. a choline derivative.
Examiner notes that OCHIAl's formula 4 is a monomer compound that is reacted with another polymer (such that the double bond would be broken to attach to the other polymer) to form a new structure, thereby overlapping with Formula 2 of Claim 1:
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Wherein Xs- is a halide ion, and R2 represented a hydrogen atom.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a choline derivative of Formula 2 in the process of KOHAMA because OCHIAI teaches that the copolymer including the monomer (B) can effectively adsorb leukocyte selectively and can copolymerize with another monomer at a specific molar ratio.
As for claim 3, KOHAMA is silent on a choline derivative.
OCHIAI teaches “According to the above-mentioned particular structure, making use of the copolymer that comprises a monomer (A), a monomer (B) and a monomer (C) having a specified structure as monomer components” (paragraph 19, lines 1-4) and “The monomer (B) having a basic functional group, which is a monomer component of the copolymer, may be any monomer which can copolymerize with the monomer (A) in a specific molar ratio” (paragraph 40, lines 1-4).
OCHIAI teaches "It is preferred that the monomer (B) is at least one monomer selected from the monomers of formulae (3), (4), (5) and (6) below, respectively" (paragraph 41; emphasis added). OCHIAI teaches the following chemical formula after paragraph 41:
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OCHIAI teaches "(wherein (R5)s represent a hydrogen or a methyl group, (R6)s independently represent. .. an alkyl group having 1 ... carbon atoms respectively, n represents an integer of 2 to 4, and (X-)s represent an anion derived from halogen" (paragraph 42), i.e. a choline derivative.
Examiner notes that OCHIAl's formula 4 is a monomer compound that is reacted with another polymer (such that the double bond would be broken to attach to the other polymer) to form a new structure, thereby overlapping with Formula 2 of Claim 3:
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Wherein Xs- is a halide ion, and R2 represented a hydrogen atom.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a choline derivative of Formula 2 in the process of KOHAMA because OCHIAI teaches that the copolymer including the monomer (B) can effectively adsorb leukocyte selectively and can copolymerize with another monomer at a specific molar ratio.
As for claim 4, KOHAMA teaches "Here, the reactive monomer composing the block copolymer (A) is not particularly limited as long as it has an epoxy group. Specific examples include glycidyl acrylate" (paragraph 45, lines 1-3), i.e. wherein the reactive monomer having an epoxy group includes at least one selected from the group consisting of glycidyl acrylate.
As for claim 5, KOHAMA teaches "In addition, the hydrophilic monomers composing the block copolymer (A) and the polymer (B) are selected from the group consisting of acrylamide and an acrylamide derivative. The acrylamide derivative is not particularly limited as long as it can impart lubricity by coming into contact with a body fluid or an aqueous solvent. Specific examples include ... N,N-dimethylacrylamide." (paragraph 46, lines 1-8), i.e. wherein the hydrophilic monomer includes at least one selected from the group consisting of N,Ndimethylacylamide.
As for claim 6, KOHAMA teaches "Further, the solvents may be used alone or in mixture of two or more thereof. In the concentration of the monomers in the polymerization solvent (for the block copolymer (A), the total concentration of the hydrophilic monomer and the reactive monomer, and for the polymer (B), the total concentration of the hydrophilic monomer) is preferably 5 to 90% by weight, more preferably 8 to 80% by weight, and particularly preferably 10 to 50% by weight" (paragraph 50, lines 10-17), i.e. wherein the solution includes a range that overlaps with 1% to 10% by mass of block copolymer. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See M PEP 2144.05.
As for claim 7, KOHAMA is silent on the choline derivative.
OCHIAI teaches "A surface treating agent is comprising a copolymer including: a monomer (A) having a hydrophilic functional group of formula (1) or (2) below, a monomer (B) having a basic functional group and a monomer (C) having a reactive functional group as monomer components, wherein the copolymer has a molar ratio of the monomer (A)/(B)/(C) between 70/15/15 to 98/1 /1" (abstract, lines 1-7) and further teaches "The monomer (C) having a reactive functional group is a monomer component of the copolymer, whatever monomer having a reactive functional group that is capable to copolymerize with the monomer (A) and (B) in a specific molar ratio may be used for a monomer component of the copolymer. The reactive functional group includes, for example, a hydroxyl group, an epoxy group, a primary amine, secondary amine or hydrogen. The monomer (C) has an effect to fix the copolymer (the surface treating agent) to the base material" (paragraph 47), i.e. wherein the solution includes an epoxy-containing block copolymer to a choline derivative at a ratio that overlaps with at a mass ratio of 1:0.005 to 1:1. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art before the effective filing date to range that overlaps with wherein the solution includes the block copolymer and the choline derivative at a mass ratio of 1:0.005 to 1:1 in the process of claim 1 because OCHIAI teaches that including the monomer (B) can effectively adsorb leukocyte selectively and can copolymerize with another monomer at a specific molar ratio.
As for claim 8, KOHAMA teaches "The block copolymer (A) and the polymer (B) after the (co )polymerization are preferably purified by a common purification method, such as reprecipitation method, a dialysis method, an ultrafiltration method, or an extraction method" (paragraph 53), i.e. wherein the block copolymer is purified.
As for claim 15, KOHAMA teaches "According to the above configuration, a medical device including a lubrication layer (coating layer) that exhibits excellent lubricity and durability, and a method for producing the medical device are provided" (paragraph 17) and "Among the materials for forming the base layer 1, the metal material is not particularly limited and a metal material that is generally used for a medical device, such as a catheter, a guidewire, and an indwelling needle may be used" (Paragraph 30, lines 1-5), i.e. A method for manufacturing a medical instrument that includes a base layer and that is configured to be positioned in a lumen or cavity in a living body.
KOHAMA teaches "A method for producing the medical device as set forth in claim 1, comprising: dissolving the block copolymer (A) and the polymer (B) in a solvent to prepare a mixture liquid; coating at least a part of the base layer with the mixture liquid; and thereafter, crosslinking or polymerizing the block copolymer (A) in the absence of a catalyst to thereby form a mesh structure on the base layer" (claim 9), i.e. applying a solution onto the base layer of the medical instrument to provide a lubricating coating layer on the medical instrument that facilitates sliding of the medical instrument in the living body when the medical instrument is brought into contact with fluid in the living body, the solution that is applied onto the base layer comprising: a block copolymer having a structural unit (A)... and a structural unit (B)... and a solvent, the solution that is applied onto the base layer being prepared by dissolving the block copolymer ... in a solvent
KOHAMA further teaches "the base layer comprises a metal material" (claim 14).
KOHAMA teaches "The reactive monomer composing the block copolymer (A) has an epoxy group as a reactive group" (paragraph 41, lines 1-2), i.e. structural unit (A) derived from a reactive monomer having an epoxy group.
KOHAMA teaches "The hydrophilic monomer(constituting unit (A-2')) composing the polymer (B)" (paragraph 44, line 1 ), i.e. a structural unit (B) derived from a hydrophilic monomer.
KOHAMA is silent on a choline derivative that promotes cross-linking or polymerization of the block copolymer to enhance sliding durability of the lubricating layer
OCHIAI teaches “According to the above-mentioned particular structure, making use of the copolymer that comprises a monomer (A), a monomer (B) and a monomer (C) having a specified structure as monomer components” (paragraph 19, lines 1-4) and “The monomer (B) having a basic functional group, which is a monomer component of the copolymer, may be any monomer which can copolymerize with the monomer (A) in a specific molar ratio” (paragraph 40, lines 1-4).
OCHIAI teaches "It is preferred that the monomer (B) is at least one monomer selected from the monomers of formulae (3), (4), (5) and (6) below, respectively" (paragraph 41; emphasis added). OCHIAI teaches the following chemical formula after paragraph 41:
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OCHIAI teaches "(wherein (R5)s represent a hydrogen or a methyl group, (R6)s independently represent. .. an alkyl group having 1 ... carbon atoms respectively, n represents an integer of 2 to 4, and (X-)s represent an anion derived from halogen" (paragraph 42), i.e. a choline derivative.
Examiner notes that OCHIAl's formula 4 is a monomer compound that is reacted with another polymer (such that the double bond would be broken to attach to the other polymer) to form a new structure, thereby overlapping with Formula 2 of Claim 1:
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Wherein Xs- is a halide ion, and R2 represented a hydrogen atom.
OCHIAI further teaches "The monomer (B) has an effect to adsorb leukocyte selectively" (paragraph 40, lines 8-9).
OCHIAI further teaches "The monomer (B) having a basic functional group, which is a monomer component of the copolymer, may be any monomer which can copolymerize with the monomer (A) in a specific molar ratio" (paragraph 40, lines 1-4), i.e. a monomer that promotes cross-linking or polymerization of the block copolymer to enhance sliding durability of the lubricating layer by crosslinking to form the lubricating layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a choline derivative of Formula 2 in the process of KOHAMA because OCHIAI teaches that the copolymer including the monomer (B) can effectively adsorb leukocyte selectively and can copolymerize with another monomer at a specific molar ratio.
As for claim 16, KOHAMA teaches "wherein the crosslinking or polymerizing are achieved by drying the coating film of the mixture liquid applied on the base layer" (claim 11), i.e. wherein after the applying of the solution onto the base layer of the medical instrument to form the lubricating coating layer, drying ... treating the lubricating coating layer.
As for claim 18, KOHAMA is silent on a choline derivative.
OCHIAI teaches “According to the above-mentioned particular structure, making use of the copolymer that comprises a monomer (A), a monomer (B) and a monomer (C) having a specified structure as monomer components” (paragraph 19, lines 1-4) and “The monomer (B) having a basic functional group, which is a monomer component of the copolymer, may be any monomer which can copolymerize with the monomer (A) in a specific molar ratio” (paragraph 40, lines 1-4).
OCHIAI teaches "It is preferred that the monomer (B) is at least one monomer selected from the monomers of formulae (3), (4), (5) and (6) below, respectively" (paragraph 41; emphasis added). OCHIAI teaches the following chemical formula after paragraph 41:
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OCHIAI teaches "(wherein (R5)s represent a hydrogen or a methyl group, (R6)s independently represent. .. an alkyl group having 1 ... carbon atoms respectively, n represents an integer of 2 to 4, and (X-)s represent an anion derived from halogen" (paragraph 42), i.e. a choline derivative.
Examiner notes that OCHIAl's formula 4 is a monomer compound that is reacted with another polymer (such that the double bond would be broken to attach to the other polymer) to form a new structure, thereby overlapping with Formula 2 of Claim 1:
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Wherein Xs- is a halide ion, and R2 represented a hydrogen atom.
OCHIAI further teaches "The monomer (B) has an effect to adsorb leukocyte selectively" (paragraph 40, lines 8-9).
OCHIAI further teaches "The monomer (B) having a basic functional group, which is a monomer component of the copolymer, may be any monomer which can copolymerize with the monomer (A) in a specific molar ratio" (paragraph 40, lines 1-4), i.e. a monomer that promotes cross-linking or polymerization of the block copolymer to enhance sliding durability of the lubricating layer by crosslinking to form the lubricating layer.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a choline derivative of Formula 2 in the process of KOHAMA because OCHIAI teaches that the copolymer including the monomer (B) can effectively adsorb leukocyte selectively and can copolymerize with another monomer at a specific molar ratio.
As for claim 21, KOHAMA teaches "According to the above configuration, a medical device including a lubrication layer (coating layer) that exhibits excellent lubricity and durability, and a method for producing the medical device are provided" (paragraph 17), and "Among the materials for forming the base layer 1, the metal material is not particularly limited and a metal material that is generally used for a medical device, such as a catheter, a guidewire, and an indwelling needle may be used" (Paragraph 30, lines 1-5), i.e. A method forming a lubricating layer that facilitates sliding of the medical instrument in the lumen or cavity in the living body when the medical instrument is brought into contact with fluid in the body.
KOHAMA teaches "A method for producing the medical device as set forth in claim 1, comprising: dissolving the block copolymer (A) and the polymer (B) in a solvent to prepare a mixture liquid; coating at least a part of the base layer with the mixture liquid; and thereafter, crosslinking or polymerizing the block copolymer (A) in the absence of a catalyst to thereby form a mesh structure on the base layer" (claim 9), i.e. preparing a solution comprising: i) a block copolymer having a structural unit (A) ... and a structural unit (B) ... iii) a solvent; applying the solution onto a base layer of a medical instrument that is configured to be positioned in a lumen or cavity in a living body; cross/inking or polymerizing the copolymer to form, on the base layer of the medical instrument.
KOHAMA teaches "The reactive monomer composing the block copolymer (A) has an epoxy group as a reactive group" (paragraph 41, lines 1-2), i.e. structural unit (A) derived from a reactive monomer having a reactive group.
KOHAMA teaches "The hydrophilic monomer(constituting unit (A-2')) composing the polymer (B)" (paragraph 44, line 1 ), i.e. a structural unit (BJ derived from a hydrophilic monomer.
KOHAMA is silent on ii) a choline derivative; and the cross/inking or polymerization being promoted by the choline derivative to enhance sliding durability of the lubricating layer.
OCHIAI teaches “According to the above-mentioned particular structure, making use of the copolymer that comprises a monomer (A), a monomer (B) and a monomer (C) having a specified structure as monomer components” (paragraph 19, lines 1-4) and “The monomer (B) having a basic functional group, which is a monomer component of the copolymer, may be any monomer which can copolymerize with the monomer (A) in a specific molar ratio” (paragraph 40, lines 1-4).
OCHIAI teaches "It is preferred that the monomer (B) is at least one monomer selected from the monomers of formulae (3), (4), (5) and (6) below, respectively" (paragraph 41; emphasis added). OCHIAI teaches the following chemical formula after paragraph 41:
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OCHIAI teaches "(wherein (R5)s represent a hydrogen or a methyl group, (R6)s independently represent. .. an alkyl group having 1 ... carbon atoms respectively, n represents an integer of 2 to 4, and (X-)s represent an anion derived from halogen" (paragraph 42), i.e. a choline derivative.
Examiner notes that OCHIAl's formula 4 is a monomer compound that is reacted with another polymer (such that the double bond would be broken to attach to the other polymer) to form a new structure, thereby overlapping with Formula 2 of Claim 1:
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Wherein Xs- is a halide ion, and R2 represented a hydrogen atom.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a ii) a choline derivative; and the crosslinking or polymerization being promoted by the choline derivative to enhance sliding durability of the lubricating layer in the process of KOHAMA because OCHIAI teaches that including the monomer (B) can effectively adsorb leukocyte selectively and can copolymerize with another monomer at a specific molar ratio.
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Kohama et al. US PGPub 2017/0258966 hereinafter KOHAMA and Ochiai et al. US PGPub 2012/0024779 hereinafter OCHIAI as applied to claim 1, 15 and 21 above, and further in view of SHINODA et al. US PGPub 2013/0095226 hereinafter SHINODA on claims 19, 20, and 22 are maintained. The rejection is updated below to meet the added claim limitations.
As for claim 19, KOHAMA teaches "A method for producing the medical device as set forth in claim 1, comprising: dissolving the block copolymer (A) and the polymer (B) in a solvent to prepare a mixture liquid; coating at least a part of the base layer with the mixture liquid; and thereafter, crosslinking or polymerizing the block copolymer (A) in the absence of a catalyst to thereby form a mesh structure on the base layer" (claim 9), i.e. crosslinking or polymerizing the copolymer to form, on the base layer of the medical instrument, the lubricating layer.
KOHAMA and OCHIAI are silent on washing the medical instrument after the cross/inking or polymerizing of the copolymer to remove at least some of the choline derivative included in the block copolymer solution before positioning the medical instrument in the lumen or cavity of the living body.
SHINODA teaches "A method for firmly fixing a hydrophilic polymer on a polyamide surface" (abstract, lines 1-2) and "Medical devices to be inserted into a living body, such as catheters and guide wires, should exhibit excellent lubricity to reduce damage to living body tissue such as blood vessel and to enhance operability for the operator'' (paragraph 3, lines 1- 4).
SHINODA teaches "After the surface lubricating layer is formed, it is possible to wash away the excess of the hydrophilic polymer with an appropriate solvent so that only the hydrophilic polymer firmly fixed on the base material is left in situ" (paragraph 63), i.e. washing the medical instrument after forming the coating to remove the unwanted reactants before positioning the medical instrument in the lumen or cavity of the living body.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a washing step in the combined process of KOHAMA and OCHIAI such that it includes washing the medical instrument after the cross/inking or polymerizing of the copolymer to remove at least some of the choline derivative included in the block copolymer solution before positioning the medical instrument in the lumen or cavity of the living body because SHI NODA teaches that such a step can remove unreacted components while maintaining the lubricating layer.
As for claim 20, KOHAMA teaches "A method for producing the medical device as set forth in claim 1, comprising: dissolving the block copolymer (A) and the polymer (B) in a solvent to prepare a mixture liquid; coating at least a part of the base layer with the mixture liquid; and thereafter, crosslinking or polymerizing the block copolymer (A) in the absence of a catalyst to thereby form a mesh structure on the base layer" (claim 9), i.e. crosslinking or polymerizing the copolymer to form, on the base layer of the medical instrument, the lubricating layer.
KOHAMA and OCHIAI are silent on washing the medical instrument after the crosslinking or polymerizing of the copolymer to remove at least some of the choline derivative included in the block copolymer solution before positioning the medical instrument in the lumen or cavity of the living body.
SHINODA teaches "A method for firmly fixing a hydrophilic polymer on a polyamide surface" (abstract, lines 1-2) and "Medical devices to be inserted into a living body, such as catheters and guide wires, should exhibit excellent lubricity to reduce damage to living body tissue such as blood vessel and to enhance operability for the operator'' (paragraph 3, lines 1- 4).
SHINODA teaches "After the surface lubricating layer is formed, it is possible to wash away the excess of the hydrophilic polymer with an appropriate solvent so that only the hydrophilic polymer firmly fixed on the base material is left in situ" (paragraph 63), i.e. washing the medical instrument after forming the coating to remove the unwanted reactants before positioning the medical instrument in the lumen or cavity of the living body.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a washing step in the combined process of KOHAMA and OCHIAI such that it includes washing the medical instrument after the crosslinking or polymerizing of the copolymer to remove at least some of the choline derivative included in the block copolymer solution before positioning the medical instrument in the lumen or cavity of the living body because SHI NODA teaches that such a step can remove unreacted components while maintaining the lubricating layer.
As for claim 22, KOHAMA teaches "A method for producing the medical device as set forth in claim 1, comprising: dissolving the block copolymer (A) and the polymer (B) in a solvent to prepare a mixture liquid; coating at least a part of the base layer with the mixture liquid; and thereafter, crosslinking or polymerizing the block copolymer (A) in the absence of a catalyst to thereby form a mesh structure on the base layer" (claim 9), i.e. crosslinking or polymerizing the copolymer to form, on the base layer of the medical instrument, the lubricating layer.
KOHAMA and OCHIAI are silent on washing the medical instrument after the crosslinking or polymerizing of the copolymer to remove at least some of the choline derivative included in the block copolymer solution before positioning the medical instrument in the lumen or cavity of the living body.
SHINODA teaches "A method for firmly fixing a hydrophilic polymer on a polyamide surface" (abstract, lines 1-2) and "Medical devices to be inserted into a living body, such as catheters and guide wires, should exhibit excellent lubricity to reduce damage to living body tissue such as blood vessel and to enhance operability for the operator'' (paragraph 3, lines 1- 4).
SHINODA teaches "After the surface lubricating layer is formed, it is possible to wash away the excess of the hydrophilic polymer with an appropriate solvent so that only the hydrophilic polymer firmly fixed on the base material is left in situ" (paragraph 63), i.e. washing the medical instrument after forming the coating to remove the unwanted reactants before positioning the medical instrument in the lumen or cavity of the living body.
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a washing step in the combined process of KOHAMA and OCHIAI such that it includes washing the medical instrument after the crosslinking or polymerizing of the copolymer to remove at least some of the choline derivative included in the block copolymer solution before positioning the medical instrument in the lumen or cavity of the living body because SHINODA teaches that such a step can remove unreacted components while maintaining the lubricating layer.
Response to Arguments
Applicant's arguments filed 4/30/26 have been fully considered but they are not persuasive.
Applicant’s principal arguments are summarized and addressed below:
(a) Applicant alleges that OCHIAI formula 4 has a moiety that neither the claimed formula 1 or 2 has, specifically a CH2=CR5-COO- moiety, and therefore cannot teach that claim.
Examiner respectfully points out that the formula 4 of OCHIAI is of a monomer that is incorporated into a larger copolymer (paragraph 35), meaning that the monomer of formula 4 is reacted with other components to make a polymer structure.
Formula 4's CH2=CR5-COO- is the unreacted monomer before it becomes a structural unit within the polymer. When reacted with the components, the double breaks to react with the components such that Formula 4 becomes, -CH2-CR5-COO- which is a moiety that is taught by Formula 2 of the claims.
Examiner reminds Applicant that the language of the claims is "wherein the choline derivative is at least one selected from the group consisting of a compound... and a polymer having a structure unit represented by the following Formula 2", OCHAIA 's reacted monomer Formula 4 certainly falls within that scope.
Applicant's argument can only be considered persuasive if they ignore that the monomers taught by OCHIAI are constituents of a larger copolymer and go on to form the structural units thereof. As such this cannot be considered persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN A DAGENAIS whose telephone number is (571)270-1114. The examiner can normally be reached 8-12 and 1-5.
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/KRISTEN A DAGENAIS/ Examiner, Art Unit 1717
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