DETAILED ACTION
Pending Claims
Claims 1-20 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 .
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 7, 8, 11, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Noishiki (US 2012/0004673 A1).
Claims 1, 4, 7, 8, 11, and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Noishiki (US 2012/0004673 A1).
Regarding claims 1, 4, 7, 8, 11, and 12, Noishiki discloses: (1) an artificial blood vessel (paragraph 0001; Example 1 in paragraphs 0094-0101) comprising: a base material comprising a fiber having a porous structure (paragraph 0094 of Example 1; see also paragraph 0076); and a coating layer formed on a surface of the base material (paragraphs 0094-0099 of Example 1), wherein the coating layer contains a hydrophilic polymer (paragraphs 0094-0095 of Example 1: see “atelocollagen” and “crosslinking agent”) and a humectant (paragraphs 0096-0099 of Example 1: see “glycerin”), and a weight ratio of the humectant to the hydrophilic polymer is 0.1 wt% to 40 wt% (paragraphs 0098-0099 of Example 1: see “5%” & “10%” embodiments);
(4) wherein the humectant contains at least one of glycerin, diglycerin, triglycerol, and ethylene glycol (paragraphs 0096-0099 of Example 1: see “glycerin”);
(7) wherein the coating layer is applied to a portion or an entirety of an outside surface of the base material (paragraphs 0094-0097 of Example 1: “reacted in solution” and “impregnated” with solution);
(8) wherein the coating layer is applied to a portion or an entirety of an inside surface of the base material (paragraphs 0094-0097 of Example 1: “reacted in solution” and “impregnated” with solution);
(11) a method for manufacturing an artificial blood vessel (paragraph 0001; Example 1 in paragraphs 0094-0101), comprising: applying, to at least a portion of a surface of a base material made of a fiber having a porous structure (paragraph 0094 of Example 1; see also paragraph 0076), a sealing material (paragraphs 0094-0099 of Example 1) containing a hydrophilic polymer (paragraphs 0094-0095 of Example 1: see “atelocollagen” and “crosslinking agent”) and a humectant (paragraphs 0096-0099 of Example 1: see “glycerin”) and having a weight ratio of the humectant to the hydrophilic polymer of 0.1 wt% to 40 wt% to form a coating layer (paragraphs 0098-0099 of Example 1: see “5%” & “10%” embodiments); and
(12) wherein applying the sealing material comprises: applying the sealing material to at least a portion of an outside surface of the base material, at least a portion of an inside surface of the base material, or both (paragraphs 0094-0097 of Example 1: “reacted in solution” and “impregnated” with solution).
Note:
The glycerin percentages reported by Noishiki are based on the combined weight of the base material, the crosslinked coating, and the glycerin humectant (see “0.6287 g” in paragraph 0095 and “0.1572” in paragraph 0099). The following table calculates the weight ratio of glycerin to the crosslinked coating, for the disclosed glycerin percentages of 5%, 10%, 15%, 20%, 25%, and 30%. The lower amounts of 5% and 10% satisfy the instantly claimed ratio of 0.1 to 40 wt%.
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Claim Rejections - 35 USC § 102/103
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 5 and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Noishiki (US 2012/0004673 A1).
Claims 5 and 14 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Noishiki (US 2012/0004673 A1).
Regarding claim 5, the teachings of Noishiki are as set forth above and incorporated herein. Noishiki fails to explicitly disclose: (5) wherein the fiber contains at least one of polyethylene terephthalate (PET) (at type of polyester), expanded polytetrafluoroethylene (ePTFE), and polyurethane. Rather, the exemplary embodiment features a polyester fiber (see paragraph 0094), and the general teachings disclose PET as an exemplary polyester (see paragraph 0076). This appears to be sufficiently specific to anticipate the instantly claimed PET fiber. At the very least, this is sufficiently specific to obviously satisfy the instantly claimed PET fiber.
Therefore if not anticipated by Noishiki, it would have been obvious to one of ordinary skill in the are before the effective filing date of claimed invention to prepare the coated artificial blood vessel of Noishiki with a PET fiber base material because: (a) the exemplary embodiment of Noishiki features a polyester fiber; and (b) the general teachings of Noishiki disclose PET as an exemplary polyester.
Regarding claim 14, the teachings of Noishiki are as set forth above and incorporated herein. Noishiki discloses: (14) wherein applying the sealing material comprises:
immersing the base material into the hydrophilic polymer for a first duration (paragraph 0094);
drying the base material coated with the hydrophilic polymer at a first temperature for a second duration (paragraph 0095);
immersing the base material coated with the hydrophilic polymer into the humectant for a third duration (paragraphs 0096-0097); and
drying the washed base material coated with the hydrophilic polymer and the humectant at a second temperature for a fourth duration (paragraph 0097).
Noishiki fails to explicitly disclose a step of: washing, with an alcohol, the base material coated with the hydrophilic polymer and the humectant. Rather, the humectant is applied to the coated material as an ethanol-diluted solution of glycerin, wherein the application can be repeated. The use of ethanol-diluted solution appears to simultaneously satisfy the steps of immersing and washing. At the very least, the repeated application of the ethanol-diluted solution of glycerin would have obviously satisfied the steps of immersing and (subsequent) washing.
Therefore if not anticipated by Noishiki, the process of Noishiki would have obviously satisfied the instantly claimed sequence of immersing and washing because: (a) the process of Noishiki embraces repeated applications of the ethanol-diluted solution of glycerin; (b) the initial application would have represented the immersing step; and (c) the subsequent application would have represented the washing step.
Claim Rejections - 35 USC § 103
Claims 6, 9, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Noishiki (US 2012/0004673 A1).
Regarding claim 6, the teachings of Noishiki are as set forth above and incorporated herein. Noishiki fails to explicitly disclose: (6) wherein the coating layer is applied to the surface of the base material in a weight of 0.05 g/cm2 to 2 g/cm2 per unit area of the base material. Rather, the initial coating provides bioabsorbable characteristics to the porous base material (see paragraphs 0001 & 0094-0095). In addition, the glycerin moisturizes the coating (see paragraphs 0001 & 0096-0099). Accordingly, the skilled artisan would have identified the relative amounts of these coating materials (coating and glycerin) as result effective variables, wherein these relative amounts dictate the extent of both the bioabsorbable characteristics and softness characteristics of the coated porous base material.
In light of this, it has been found that, “[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,” – In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation,” –In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the coated artificial blood vessel of Noishiki with the instantly claimed coating weight (0.05 g/cm2 to 2 g/cm2 per unit area of the base material) because: (a) the initial coating of Noishiki provides bioabsorbable characteristics to the porous base material; (b) the glycerin of Noishiki moisturizes the coating; and (c) the skilled artisan would have identified the relative amounts of these coating materials (coating and glycerin) as result effective variables, wherein these relative amounts dictate the extent of both the bioabsorbable characteristics and softness characteristics of the coated porous base material. Furthermore: (d) it has been found that, “[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;” and (e) it has been found that “A particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation.”
Regarding claim 9, the teachings of Noishiki are as set forth above and incorporated herein. Noishiki fails to disclose: (9) wherein the base material forms a tube shape having an outer diameter between 12 mm and 30 mm, a thickness between 0.1 mm to 1 mm, and a length between 100 mm to 600 mm. Rather, Noishiki discloses a blood vessel (tube) length of 6 cm with an inner diameter of 8 mm (see paragraph 0094). However, it has been found that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” – see MPEP 2144.04 IV. A.
Regarding claims 16 and 17, the teachings of Noishiki are as set forth above and incorporated herein. Noishiki fails to explicitly disclose: (16) further comprising: preparing a glycerin aqueous solution at 25% weight per volume, wherein the glycerin aqueous solution is the humectant; and (17) further comprising: preparing a glycerin aqueous solution at 50% weight per volume, wherein the glycerin aqueous solution is the humectant. Rather, Noishiki discloses glycerin solutions, which are diluted with ethanol. These solutions have various concentrations ranging from 1% to 50% (see paragraphs 0097-0098). They fail to explicitly disclose an aqueous solution. However, the skilled artisan would have expected some level of water to be present because: (a) ethanol typically has a water content; and (b) glycerin is hygroscopic.
Claims 2, 3, 13, 15, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Noishiki (US 2012/0004673 A1) in view of Wallace et al. (US 2002/0165337 A1).
Regarding claims 2, 3, and 15, the teachings of Noishiki are as set forth above and incorporated herein. The exemplary embodiments of Noishiki feature a bioabsorbable polymer that undergoes crosslinking (see paragraphs 0094-0095). However, they fail to disclose: (2) wherein the hydrophilic polymer is a four-branched polymer having a polyethylene glycol (PEG) skeleton; (3) wherein the hydrophilic polymer comprises Tetra-PEG, the Tetra-PEG generated by an interlinking reaction between a first four-branched polymer represented by formula (1) and a second four-branched polymer represented by formula (2):
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wherein each of functional groups X1 to X4 of formula (1) represents any one of an amino group, a thiol group, a carboxyl group, and an aldehyde group; and (15) further comprising: mixing a first solution and a second solution in a one-to-one ratio to form the hydrophilic polymer, wherein the first solution contains Tetra-PEG comprising a thiol group at each of the terminals of the Tetra-PEG, and wherein the second solution contains Tetra-PEG comprising an N-hydroxy ester at each of the terminals of the Tetra-PEG.
Wallace et al. disclose a biocompatible gel that undergoes crosslinking (see Abstract). They disclose an exemplary two-component material having a first component of pentaerythritol poly(ethylene glycol) ether tetra-succinimidyl glutarate (corresponding to formula 2) and a second component of pentaerythritol poly(ethylene glycol) ether tetra-sulfhydryl (corresponding to formula 1) (see paragraphs 0218-0222). These components are then combined in equal parts to form the biocompatible gel (see paragraph 0223). Wallace et al. disclose that their biocompatible gels are suitable for various applications, including coating artificial blood vessels (see paragraphs 0206-0209, especially paragraph 0208). In light of this, it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination – see MPEP 2144.07.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare the coated artificial blood vessel of Noishiki with the instantly claimed hydrophilic polymer system because: (a) the exemplary embodiments of Noishiki feature a bioabsorbable polymer that undergoes crosslinking; (b) Wallace et al. disclose a biocompatible gel that undergoes crosslinking; (c) Wallace et al. disclose an exemplary two-component material having a first component of pentaerythritol poly(ethylene glycol) ether tetra-succinimidyl glutarate (corresponding to formula 2) and a second component of pentaerythritol poly(ethylene glycol) ether tetra-sulfhydryl (corresponding to formula 1), which are combined in equal parts to form the biocompatible gel; (d) Wallace et al. disclose that their biocompatible gels are suitable for various applications, including coating artificial blood vessels; and (e) it has been found that the selection of a known material based on its suitability for its intended use supports a prima facie obviousness determination.
Regarding claims 18-20, the combined teachings of {Noishiki and Wallace et al.} are as set forth above and incorporated herein to obviously satisfy the instantly claimed coating layer set forth in claims (18-20).
Regarding claim 13, the combined teachings of {Noishiki and Wallace et al.} are as set forth above and incorporated herein. The exemplary embodiments of Noishiki perform coating by immersion. Accordingly the fail to disclose: (13) spraying the sealing material on at least the portion of the surface of the base material until the porous structure of the base material is filled with the sealing material. However, the teachings of Wallace et al. demonstrate that it is also recognized in the art to apply this type of biocompatible coating to an artificial blood vessel using a spray technique (see paragraphs 0207-0028).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a spray coating technique in the process of Noishiki because: (a) the exemplary embodiments of Noishiki perform coating by immersion; and (b) the teachings of Wallace et al. demonstrate that it is also recognized in the art to apply this type of biocompatible coating to an artificial blood vessel using a spray technique.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Noishiki (US 2012/0004673 A1) in view of Kenda (US Pat. No. 5,807,354).
Regarding claim 10, the teachings of Noishiki are as set forth above and incorporated herein. Noishiki fails to explicitly disclose: (10) wherein the base material forms a tube shape comprising a ring-shaped rib pattern, the ring- shaped rib pattern formed on at least the outside surface of the base material. However, the teachings of Kenda demonstrate that this type of ring-shaped rib pattern is advantageous in terms of providing added flexibility to the tubular implant (see Abstract; column 3, lines 11-16; see also claim 12).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the instantly claimed base material in the coated artificial blood vessel of Noishiki because: (a) the artificial blood vessel of Noishiki has a tube shape; and (b) the teachings of Kenda demonstrate that the instantly claimed ring-shaped rib pattern is advantageous in terms of providing added flexibility to the tubular implant.
Communication
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/MICHAEL J FEELY/Primary Examiner, Art Unit 1766
November 15, 2025