DETAILED ACTION
This Office Action is responsive to the Amendment filed 27 August 2025. Claims 1 – 5 and 7 - 20 are now pending. The Examiner acknowledges the amendments to claims 1 – 2, 9, 11, and 19 as well as the cancellation of claims 6 and 21.
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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 1, 3 – 5, and 7 – 10 are rejected under 35 U.S.C. 103 as being unpatentable over Futoshi (WO 2017038557 A1, see attached translation) in view of Field (US 20030040756 A1) in view of Matsubara et al (US 20020004111 A1, hereinafter Matsubara) in further view of Qiao et al (2015, hereinafter Qiao; NPL: U).
Regarding claim 1, Futoshi teaches an embryo transfer tool (“instrument 1 for embryo transplantation”, abstract) comprising:
a flexible tube (“flexible tube 21”, page 6, paragraph 2) that is made of a colorless and transparent synthetic resin (“Examples of the material for forming the flexible tube 21 include polyester, polyolefin (for example, polyethylene, polypropylene ethylene-propylene copolymer), polyamide (for example, 6 nylon, 66 nylon), polyester (for example, polyethylene terephthalate), fluororesin (for example, , PTFE, ETFE) and the like can be used”, page 6, paragraph 2),
the flexible tube (21) having a longitudinal extent and a central axis that extends along the longitudinal extent of the flexible tube (21) (Figure 7),
the flexible tube (21) including a lumen (cavity of “flexible tube 11”, Figure 7) that extends along at least a part of the longitudinal extent of the flexible tube (21) (Figure 7),
the flexible tube (21) having an inner surface surrounding the lumen and also having an outer surface facing away from the lumen (Figure 7); and
a hub (“hub 12”, page 5, paragraph 5) that is provided at a proximal end portion of the flexible tube (21) (Figure 7),
wherein the flexible tube (21) includes:
a first microparticle-containing synthetic resin portion (“a first bubble-containing surface layer” 13a, page 3, paragraph 2; Figure 1) comprised of synthetic resin containing microparticles that are optically transparent hollow beads (“bubbles”, page 3, paragraph 3),
the first microparticle-containing synthetic resin portion (13a) having a predetermined width (Figure 6 shows 13a at a predetermined width) and extends extending over a predetermined length from a distal end portion of the flexible tube (21) toward a proximal end of the flexible tube (21) (page 3, paragraph 2; Figure 1),
the first microparticle-containing synthetic resin portion (13a) having an outer periphery as seen in a transverse cross-section of the flexible tube (21) that is transverse to the central axis of the flexible tube (21) and that passes through the first microparticle-containing synthetic resin portion (13a) (Figure 6);
a second microparticle-containing synthetic resin portion (“second bubble-containing surface layer” 13b, page 3, paragraph 2) comprised of synthetic resin that contains microparticles that are optically transparent hollow beads (“bubbles”, page 3, paragraph 3),
the second microparticle-containing synthetic resin portion (13b) having a predetermined width (Figure 6 shows 13b at a predetermined width), extending from the distal end portion of the flexible tube (21) toward the proximal end of the flexible tube (21) (“A second bubble-containing surface layer 13b facing 13a, located between the first bubble-containing surface layer 13a and the second bubble-containing surface layer 13b, extending a predetermined length from the distal end of the flexible tube 11 toward the proximal end”, page 3, paragraph 2), and being opposed to the first microparticle-containing synthetic resin portion (13a) (Figure 6 shows 13b is on the opposing side from 13a),
the second microparticle-containing synthetic resin portion (13b) having an outer periphery as seen in the transverse cross-section of the flexible tube (21) (Figure 6);
a first microparticle-free portion (“first colorless and transparent portion” 15a, page 3, paragraph 2) comprised of synthetic resin (“…polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer)…”, page 6, paragraph 2) that is free of microparticles (Figures 1, 5 and 6), the first microparticle-free portion being colorless, transparent (13a) and positioned between the first microparticle-containing synthetic resin portion (13a) and the second microparticle-containing synthetic resin portion (13b) (Figures 1; 5 and 6),
the first microparticle-free portion (15a) extending over a predetermined length from a distal end of the flexible tube (21) toward the proximal end of the flexible tube (21) (Figures 1; 5 and 6); and
a second microparticle-free portion comprised of synthetic resin (“a second colorless and transparent portion” 15b, page 3, paragraph 2) that is free of microparticles (Figures 1, 5 and 6), the second microparticle-free portion (15b) being colorless, transparent and positioned in opposing relation to the first microparticle-free portion (15a) (Figure 6 shows 15b is on the opposing side from 15a),
so that the outer periphery of the first microparticle-containing synthetic resin portion (13a) and the outer periphery of the second microparticle-containing synthetic resin portion (13b) are spaced from the outer surface of the flexible tube (21) as seen in the transverse cross-section (Figure 6) and
so that the outer periphery of the first microparticle-containing synthetic resin portion (13a) and the outer periphery of the second microparticle-containing synthetic resin portion (13b) are spaced from the inner surface of the flexible tube as seen in the transverse cross-section (Figure 6),
the synthetic resin of the first and second microparticle-containing synthetic resin portions (respectively, 13a and 13b) being a colorless and transparent synthetic resin (page 3, paragraph 6; Examiner interprets the “soft tube 11” contains the “a first bubble-containing surface layer 13a” and “second bubble-containing surface layer 13b” and can be made of colorless and transparent resin such as “polyolefin (polyethylene, polypropylene)”.).
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Futoshi does not teach the microparticle-containing synthetic resin portions are positioned within an inner wall of the flexible tube, are not exposed on an outer surface and an inner surface of the flexible tube, and the optically transparent hollow glass beads having a diameter of 0.5 to 200 μm, the optically transparent hollow glass beads are dispersed in the synthetic resin, and the microparticle-containing synthetic resin portions including boundary surfaces that are formed between the synthetic resin and the optically transparent hollow glass beads, the optically transparent hollow glass beads having an average particle size of 10 to 80 μm, an effective hydrostatic pressure under which 10 volume % of the glass beads collapse is at least 3 megapascals; and a ratio of the volume of the optically transparent hollow glass beads contained in the microparticle-containing portions is 5% to 20%; and wherein the embryo transfer tool includes, at a distal end portion thereof, an annular transparent distal end portion that does not include the microparticle-containing portions, and the microparticles-containing portions are not exposed in the distal end surface of the embryo transfer tool.
However, Field discloses an “embryo replacement catheter has a flexible extruded shaft of a transparent polyurethane with a bore extending along its length” and teaches the microparticle-containing synthetic resin portions (Figure 2) are positioned within an inner wall ([0018], Figure 2) of the flexible tube (“extruded shaft”, [0008]), are not exposed on an outer surface and an inner surface of the flexible tube (“the outer surface of the device may be smooth and uninterrupted by gas bubbles, and the device may have an inner surface that is smooth and uninterrupted by gas bubbles”, [0007]; Figure 2), and the optically transparent hollow glass beads (“The bubbles could be formed by the incorporation of hollow microspheres of resin or glass.”, [0023]) having a diameter of 1 to 50 μm ([0023]),
the optically transparent hollow glass beads ([0023]) are dispersed in the synthetic resin ([0023]), and the microparticle-containing synthetic resin portions (Figure 2) including boundary surfaces that are formed between the synthetic resin (“Polyurethane material 21”, [0020]) and the optically transparent hollow glass beads ([0023]) (Examiner interprets that the outer surface and inner surface are uninterrupted by gas bubbles as well as at the distal end.) and
wherein teaches the embryo transfer tool (“embryo replacement catheter”, abstract) includes, at a distal end portion (“patient end 11” [0018] Figure 1) thereof, an annular transparent distal end portion (“patient end 11” [0018] Figure 1) that does not include the microparticle-containing portions, and the microparticles-containing portions are not exposed in the distal end surface of teaches the embryo transfer tool (“embryo replacement catheter”, abstract) (“The outer and inner surfaces 13 and 14 of the shaft may be smooth and uninterrupted by gas bubbles or the bubbles may break the surface.” [0018] Figures 1 and 2; Examiner interprets the distal end portion does not include and/or expose the microparticles-containing portions considering “the shaft may be smooth and uninterrupted by gas bubbles”.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embryo transfer tool of Futoshi to incorporate the microparticle-containing synthetic resin portions are positioned within an inner wall of the flexible tube, are not exposed on an outer surface and an inner surface of the flexible tube, and the optically transparent hollow glass beads having a diameter of 0.5 to 200 μm, the optically transparent hollow glass beads are dispersed in the synthetic resin, and the microparticle-containing synthetic resin portions including boundary surfaces that are formed between the synthetic resin and the optically transparent hollow glass beads and wherein the embryo transfer tool includes, at a distal end portion thereof, an annular transparent distal end portion that does not include the microparticle-containing portions, and the microparticles-containing portions are not exposed in the distal end surface of the embryo transfer tool, as taught by Field, for the benefit of “increase[ing] the visibility of the catheter under ultrasound imaging whilst still enabling material flowing along the catheter to be seen” (Field: abstract) and preventing abrasions in patient’s and/or healthcare professional’s body when in use.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embryo transfer tool of Futoshi to incorporate at a distal end portion thereof, an annular transparent distal end portion that does not include the first and second microparticle-containing portions, as taught by Field, for the benefit of preventing abrasions in patient’s and/or healthcare professional’s body when in use.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optically transparent hollow glass bead’s diameter of the embryo transfer tool of Futoshi such as a range of 1 to 50 μm, as taught by Field, for the benefit of increase the visibility of the device under ultrasound observation (Field: [0009]). Furthermore, it has been held that “[i]n 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).” See MPEP 2144.05(I). Applicant appears to have placed no criticality on the claimed range.
The modified invention of Futoshi and Field does not teach the optically transparent hollow glass microspheres having an average particle size that is 10 to 80 μm, an effective hydrostatic pressure under which 10 volume % of the glass beads collapse is at least 3 megapascals; and a ratio of the volume of the optically transparent hollow glass beads contained in the microparticle-containing portion is 5% to 20%.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optically transparent hollow glass bead’s diameter of the embryo transfer tool of Futoshi such as a range of 1 to 50 μm, as taught by Field, for the benefit of increase the visibility of the device under ultrasound observation (Field: [0009]). Furthermore, it has been held that “[i]n 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).” See MPEP 2144.05(I). Applicant appears to have placed no criticality on the claimed range.
The modified invention of Futoshi and Field does not teach the optically transparent hollow glass microspheres having an effective hydrostatic pressure under which 10 volume % of the glass beads collapse is at least 3 megapascals; and a ratio of the volume of the optically transparent hollow glass beads contained in the microparticle-containing portion is 5% to 20%.
However, Matsubara discloses “a hollow aluminosilicate glass microsphere comprising a glass composition containing no or substantially no alkali metal and having substantially no eluted amount of boron, and a method for producing the same” ([0001]) and an effective hydrostatic pressure under which 10 volume % of the glass beads collapse is at least 3 megapascals (“a fracture strength of at least 50 MPa at the time when 10% volume is reduced based on volume under hydrostatic pressure”, [0020], [0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optically transparent hollow glass microspheres of Futoshi and Field to incorporate an effective hydrostatic pressure under which 10 volume % of the glass beads collapse is at least 3 megapascals, as taught by Matsubara, for the benefit of preventing the “fractur[ing] at the time of preparing a compound or during” use (Matsubara: [0020]).
The modified invention of Futoshi, Field and Matsubara does not teach a ratio of the volume of the optically transparent hollow glass beads contained in the microparticle-containing portion is 5% to 20%.
However, Qiao discloses “density, thermal conductivity, and compressive properties of hollow glass microsphere (HGM)-filled epoxy composites were investigated” and teaches a ratio of the volume of the optically transparent glass beads contained in the microparticle-containing portions being 5% to 20% (Figure 2b depicts 10 volume % and Figure 2c depicts 20 volume %). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embryo transfer tool of Futoshi, Field and Matsubara such that a ratio of the volume of the optically transparent glass beads contained in the microparticle-containing portions being 5% to 20%, as taught by Qiao, for the benefit of adjusting the composition to the desired compressive modulus and strength needed for the user (page 1416, column 1, paragraph 4).
Regarding claim 3, Futoshi and Field teach all limitations of claim 1. Futoshi teaches the synthetic resin forming the first and second microparticle-containing synthetic resin portions (“a first bubble-containing surface layer” 13a, page 3, paragraph 2; Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2) is the same as the colorless and transparent synthetic resin (“polyolefin (polyethylene, polypropylene)”, page 3, paragraph 6 for “soft tube 11”; “polyolefin (for example, polyethylene, polypropylene”, page 6, paragraph 2 for “flexible tube 21”) forming the flexible tube (“flexible tube 21”, page 6, paragraph 2). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions and both flexible tube and soft tube from Futoshi can be from the same material and reads on the limitation “is same the colorless and transparent synthetic resin”.
Regarding claim 4, Futoshi and Field teach all limitations of claim 1. Futoshi teaches the synthetic resin forming the first and second microparticle-containing synthetic resin portions has higher flexibility than the colorless and transparent synthetic resin forming the flexible tube (“flexible tube 21”, page 6, paragraph 2) (“As a material for forming the flexible tube 21, a material that is harder than the soft tube 11 and has a certain degree of shape retention and flexibility is used.”, page 6, paragraph 2). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions (page 6, paragraph 7) and that harder material has less flexibility.
Regarding claim 5, Futoshi and Field teach all limitations of claim 1. Futoshi teaches the first and second microparticle-containing synthetic resin portions (respectively, “a first bubble-containing surface layer” 13a, page 3, paragraph 2, Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2) have a flexibility that is equivalent to flexibility of the synthetic resin forming the flexible tube (21) ((“polyolefin (polyethylene, polypropylene)”, page 3, paragraph 6 for “soft tube 11”; “polyolefin (for example, polyethylene, polypropylene”, page 6, paragraph 2 for “flexible tube 21”). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions and both flexible tube and soft tube from Futoshi can be from the same material and reads on the limitation “has flexibility that is equivalent to flexibility”.
Regarding claim 7, Futoshi and Field teach all limitations of claim 1. Futoshi teaches a thickness of each of the first and second microparticle-containing synthetic resin portions is 1/5 to 1/3 of a thickness of the flexible tube (“flexible tube 21”, page 6, paragraph 2) (“thickness of the first and second bubble-containing surface layers is 1/5 to 1/3 of the thickness of the soft tube” page 6, paragraph 8).
Regarding claim 8, Futoshi and Field teach all limitations of claim 1. Futoshi teaches a width of each of the first and second microparticle-containing synthetic resin portions is at least 30/100 of an outer circumferential length of the flexible tube (“the width of the first and second colorless and transparent portions is 30/100 or more of the outer peripheral length of the soft tube”, page 6, paragraph 7).
Regarding claim 9, Futoshi and Field teach all limitations of claim 1. Futoshi teaches an embryo transfer device (“embryo transfer device 10”, page 5, paragraph 8) comprising:
the embryo transfer tool (“instrument 1 for embryo transplantation”, abstract) according to claim 1,
the flexible tube (“flexible tube 21”, page 6, paragraph 2) being a first flexible tube (21); and
a sheath (“sheath” 2, page 5, paragraph 9) that includes a second flexible tube (“soft tube” 11, page 5, paragraph 9) and a sheath hub (“sheath hub” 22, page 5, paragraph 7) that is provided at a proximal end of the second flexible tube (11), the second flexible tube (“soft tube” 11, page 5, paragraph 9) being made of a material that is harder than a material from which the first flexible tube (21) of the embryo transfer tool (1) is made so that the second flexible tube (1) is harder than the first flexible tube (21) of the embryo transfer tool (1) (“hard sheath”, page 2, paragraph 2; “hard resin”, page 5, paragraph 7; “For example, synthetic rubber such as urethane rubber, silicone rubber and butadiene rubber, natural rubber such as latex rubber, soft vinyl chloride, polyolefin (polyethylene, polypropylene). , Ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, a mixture of polypropylene and polyethylene or polybutene), polyester (polyethylene terephthalate, polybutylene terephthalate), polyamide, polyolefin elastomer, polyamide elastomer, styrene elastomer (for example, styrene) -Butadiene-styrene copolymer, styreneisoprene-styrene copolymer, styrene-ethylenebutylene-styrene copolymer), etc. Elastomers, polyurethanes, in particular thermoplastic polyurethanes (thermoplastic polyether polyurethanes, thermoplastic polyester polyurethanes, particularly preferably segmented thermoplastic polyether polyurethanes having a soft segment part and a hard segment part, more particularly soft As the main component of the segment, polytetramethylene ether glycol, polyethylene glycol, polypropylene glycol and the like are preferable, and as the main component of the hard segment, 1,4-butanediol and the like are preferable.”, page 3 paragraph 6), the sheath (2) accommodating the first flexible tube (21) with the distal end portion of the first flexible tube (21) projecting from the sheath (2) (Figure 7).
Regarding claim 10, Futoshi and Field teach all limitations of claim 9. Futoshi teaches a portion of the first flexible tube (“flexible tube 21”, page 6, paragraph 2) projects from a distal end of the sheath (2), at least a part of the portion of the first flexible tube (21) that projects from the distal end of the sheath (2) including the first and second microparticle- containing synthetic resin portions (“a first bubble-containing surface layer” 13a, page 3, paragraph 2; Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Futoshi in view of Field, as applied in claim 1, in view of Ogura (US 20100036201 A1).
Regarding claim 2, Futoshi and Field teach all limitations of claim 1. Futoshi teaches the first and second microparticle-containing synthetic resin portions (respectively, 13a and 13b, page 3, paragraph 2) and optically clear hollow beads (“bubbles”, page 3, paragraph 3) but does not teach the microparticle-containing synthetic resin portion contains 0.5 - 5 parts by weight of the optically transparent hollow glass beads per 100 parts by weight of the synthetic resin of the microparticle-containing synthetic resin portion.
However, Ogura discloses “an endoscopic flexible tube, including a spiral tube, a mesh tube covering the spiral tube, and a sheath coating the outer surface of the mesh tube, the sheath being composed of a sheathing resin material containing closed cells” (abstract) and teaches the microparticle-containing synthetic resin portion (“sheathing material”, [0040]) contains 45 or less parts by weight of the optically clear hollow glass beads (“hollow microspheres”, [0040]) per 100 parts by weight of the synthetic resin (“sheathing resin material”, [0040]) of the microparticle-containing synthetic resin portion. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microparticle-containing synthetic resin portions of the microparticle-containing synthetic resin portion of the embryo transfer tool of Futoshi such as a range of 0.5 - 5, as taught by Ogura, for the benefit of reducing the specific gravity of the sheath to increase its elasticity while preventing embrittlement. Furthermore, it has been held that “[i]n 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).” See MPEP 2144.05(I). Applicant appears to have placed no criticality on the claimed range.
Claims 11 and 13 - 20 are rejected under 35 U.S.C. 103 as being unpatentable over Futoshi in view of Field in view of Matsubara et al (US 20020004111 A1, hereinafter Matsubara) in further view of Qiao et al (2015, hereinafter Qiao; NPL: U).
Regarding claim 11, Futoshi teaches an embryo transfer tool (“instrument 1 for embryo transplantation”, abstract) comprising:
a flexible tube (“flexible tube 21”, page 6, paragraph 2) that is made of a colorless and transparent synthetic resin (“Examples of the material for forming the flexible tube 21 include polyester, polyolefin (for example, polyethylene, polypropylene ethylene-propylene copolymer), polyamide (for example, 6 nylon, 66 nylon), polyester (for example, polyethylene terephthalate), fluororesin (for example, , PTFE, ETFE) and the like can be used”, page 6, paragraph 2),
the flexible tube (21) having an outer surface and an inner surface (Figure 7); and
a hub (“hub 12”, page 5, paragraph 5) that is provided at a proximal end portion of the flexible tube (21), wherein the flexible tube (21) includes:
a first microparticle-containing synthetic resin portion (“a first bubble-containing surface layer” 13a, page 3, paragraph 2; Figure 1) that is made of synthetic resin containing optically transparent hollow beads as microparticles (“bubbles”, page 3, paragraph 3), wherein the first microparticle-containing synthetic resin portion has a predetermined width (Figure 6 shows 13b at a predetermined width) and extends over a predetermined length from a distal end portion of the flexible tube toward a proximal end of the flexible tube (21) (page 3, paragraph 2; Figure 1);
a second microparticle-containing synthetic resin portion (“second bubble-containing surface layer” 13b, page 3, paragraph 2) that is made of synthetic resin containing optically transparent hollow beads as microparticles (“bubbles”, page 3, paragraph 3), wherein the second microparticle-containing synthetic resin portion has a predetermined width and extends from the distal end portion of the flexible tube (21) toward the proximal end of the flexible tube (21) (“A second bubble-containing surface layer 13b facing 13a, located between the first bubble-containing surface layer 13a and the second bubble-containing surface layer 13b, extending a predetermined length from the distal end of the flexible tube 11 toward the proximal end”, page 3, paragraph 2), wherein the second microparticle-containing synthetic resin portion is opposed to the first microparticle containing synthetic resin portion (13a) (Figure 6 shows 13b is on the opposing side from 13a);
a first microparticle-free portion (“first colorless and transparent portion” 15a, page 3, paragraph 2) that is made of synthetic resin (“…polyolefin (for example, polyethylene, polypropylene, ethylene-propylene copolymer)…”, page 6, paragraph 2) free of any microparticles (Figures 1, 5 and 6), that is colorless, transparent and positioned between the first microparticle-containing synthetic resin portion (13a) and the second microparticle-containing synthetic resin portion (13b), and that extends over a predetermined length from a distal end of the flexible tube (21) toward the proximal end (Figures 1; 5 and 6);
a second microparticle-free portion (“a second colorless and transparent portion” 15b, page 3, paragraph 2) that is made of synthetic resin free of any microparticles (Figures 1, 5 and 6), and is colorless, transparent and positioned in opposing relation to the first microparticle-free portion (15a) (Figure 6 shows 15b is on the opposing side from 15a);
the first and second microparticle-containing synthetic resin portions (“a first bubble-containing surface layer” 13a, page 3, paragraph 2; Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2) being formed by a colorless and transparent synthetic resin ((“polyolefin (polyethylene, polypropylene)”, page 3, paragraph 6 for “soft tube 11”; “polyolefin (for example, polyethylene, polypropylene”, page 6, paragraph 2 for “flexible tube 21”); Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions and both flexible tube and soft tube from Futoshi can be from the same material and reads on the limitation.)
the synthetic resin forming the first microparticle-containing synthetic resin portion (13a) having higher flexibility than the colorless and transparent synthetic resin forming the flexible tube (21) (“As a material for forming the flexible tube 21, a material that is harder than the soft tube 11 and has a certain degree of shape retention and flexibility is used.”, (page 6, paragraph 2). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions (page 6, paragraph 7) and that harder material has less flexibility.):
the synthetic resin forming the second microparticle-containing synthetic resin portion (13b) having higher flexibility than the colorless and transparent synthetic resin forming the flexible tube (21) (“As a material for forming the flexible tube 21, a material that is harder than the soft tube 11 and has a certain degree of shape retention and flexibility is used.”, (page 6, paragraph 2). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions (page 6, paragraph 7) and that harder material has less flexibility.):
the first and second microparticle-containing synthetic resin portions (respectively, 13a and 13b, page 3, paragraph 2) have a flexibility equivalent to the flexibility of the flexible tube (21) ((“polyolefin (polyethylene, polypropylene)”, page 3, paragraph 6 for “soft tube 11”; “polyolefin (for example, polyethylene, polypropylene”, page 6, paragraph 2 for “flexible tube 21”; Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions and both flexible tube and soft tube from Futoshi can be from the same material and reads on the limitation “has flexibility that is equivalent to flexibility”.):
wherein the colorless and transparent synthetic resin (“Examples of the material for forming the flexible tube 21 include polyester, polyolefin (for example, polyethylene, polypropylene ethylene-propylene copolymer), polyamide (for example, 6 nylon, 66 nylon), polyester (for example, polyethylene terephthalate), fluororesin (for example, , PTFE, ETFE) and the like can be used”, page 6, paragraph 2) forming the flexible tube (21) is located between the inner surface of the flexible tube (21) and the synthetic resin forming the first microparticle-containing synthetic resin portion (13a) as seen in a transverse cross-section of the flexible tube (21) (see annotated Futoshi’s Figure 6):
wherein the colorless and transparent synthetic resin (“Examples of the material for forming the flexible tube 21 include polyester, polyolefin (for example, polyethylene, polypropylene ethylene-propylene copolymer), polyamide (for example, 6 nylon, 66 nylon), polyester (for example, polyethylene terephthalate), fluororesin (for example, , PTFE, ETFE) and the like can be used”, page 6, paragraph 2) forming the flexible tube (21) is located between the outer surface of the flexible tube (21) and the synthetic resin forming the first microparticle-containing synthetic resin portion (13a) as seen in the transverse cross-section of the flexible tube (21) (see annotated Futoshi’s Figure 6):
wherein the colorless and transparent synthetic resin forming the flexible tube is
located between the inner surface of the flexible tube and the synthetic resin forming the
second microparticle-containing synthetic resin portion as seen in the transverse cross-section
of the flexible tube (21) (see annotated Futoshi’s Figure 6): and
wherein the colorless and transparent synthetic resin (“Examples of the material for forming the flexible tube 21 include polyester, polyolefin (for example, polyethylene, polypropylene ethylene-propylene copolymer), polyamide (for example, 6 nylon, 66 nylon), polyester (for example, polyethylene terephthalate), fluororesin (for example, , PTFE, ETFE) and the like can be used”, page 6, paragraph 2) forming the flexible tube (21) is located between the outer surface of the flexible tube (21) and the synthetic resin forming the second microparticle-containing synthetic resin portion (13b) as seen in the transverse cross-section of the flexible tube (21) (see annotated Futoshi’s Figure 6).
Futoshi does not teach the microparticle-containing synthetic resin portions are positioned within an inner wall of the flexible tube, having an outer periphery that faces towards and is spaced from the inner surface and the outer surface of the flexible tube so that the outer periphery of the microparticle-containing synthetic resin portions is not exposed on the outer surface and the inner surface of the flexible tube, the optically transparent hollow glass beads are dispersed in the synthetic resin, and the microparticle-containing synthetic resin portions including boundary surfaces that are formed between the synthetic resin and the optically transparent hollow glass beads, the optically transparent hollow glass beads having an average particle size of 10 to 80 μm, an effective hydrostatic pressure under which 10 volume % of the glass beads collapse is at least 3 megapascals; and a ratio of the volume of the optically transparent hollow glass beads contained in the microparticle-containing portions is 5% to 20%; and wherein the embryo transfer tool includes, at a distal end portion thereof, an annular transparent distal end portion that does not include the microparticle-containing portions, and the microparticles-containing portions are not exposed in the distal end surface of the embryo transfer tool.
However, Field discloses an “embryo replacement catheter has a flexible extruded shaft of a transparent polyurethane with a bore extending along its length” (abstract) and teaches the microparticle-containing synthetic resin portions (Figure 2) are positioned within an inner wall ([0018], Figure 2) of the flexible tube (“the outer surface of the device may be smooth and uninterrupted by gas bubbles, and the device may have an inner surface that is smooth and uninterrupted by gas bubbles”, [0007]; Figure 2),
having an outer periphery that faces towards and is spaced from the inner surface and the outer surface of the flexible tube so that the outer periphery of the microparticle-containing synthetic resin portions (Figure 2) is not exposed on the outer surface and the inner surface of the flexible tube ([0007]; Figure 2) (“the outer surface of the device may be smooth and uninterrupted by gas bubbles, and the device may have an inner surface that is smooth and uninterrupted by gas bubbles”, [0007]; Figure 2),
the optically transparent hollow glass beads (“The bubbles could be formed by the incorporation of hollow microspheres of resin or glass.”, [0023]) are dispersed in the synthetic resin ([0023]), and
the microparticle-containing synthetic resin portions (Figure 2) including boundary surfaces that are formed between the synthetic resin (“Polyurethane material 21”, [0020]) and the optically transparent hollow glass beads ([0023]), and
the optically transparent hollow glass beads ([0023]) having an average particle size of 1 to 50 μm ([0023]); and
wherein the embryo transfer tool (“embryo replacement catheter”, abstract) includes, at a distal end portion (“patient end 11” [0018] Figure 1) thereof, an annular transparent distal end portion (“patient end 11” [0018] Figure 1) that does not include the microparticle-containing portions, and the microparticles-containing portions are not exposed in the distal end surface of the embryo transfer tool (“embryo replacement catheter”, abstract) (“The outer and inner surfaces 13 and 14 of the shaft may be smooth and uninterrupted by gas bubbles or the bubbles may break the surface.” [0018] Figures 1 and 2; Examiner interprets the distal end portion does not include and/or expose the microparticles-containing portions considering “the shaft may be smooth and uninterrupted by gas bubbles”.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embryo transfer tool of Futoshi such that teaches the microparticle-containing synthetic resin portions are positioned within an inner wall of the flexible tube,
having an outer periphery that faces towards and is spaced from the inner surface and the outer surface of the flexible tube so that the outer periphery of the microparticle-containing synthetic resin portions is not exposed on the outer surface and the inner surface of the flexible tube, the optically transparent hollow glass beads, and the microparticle-containing synthetic resin portions including boundary surfaces that are formed between the synthetic resin and the optically transparent hollow glass beads, and the optically transparent hollow glass beads having an average particle size of 1 to 50 μm, as taught by Field, for the benefit of “increase[ing] the visibility of the device under ultrasound imaging” (Field: [0006]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embryo transfer tool of Futoshi to incorporate at a distal end portion thereof, an annular transparent distal end portion that does not include the first and second microparticle-containing portions, as taught by Field, for the benefit of preventing abrasions in patient’s and/or healthcare professional’s body when in use.
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optically transparent hollow glass bead’s diameter of the embryo transfer tool of Futoshi such as a range of 1 to 50 μm, as taught by Field, for the benefit of increase the visibility of the device under ultrasound observation (Field: [0009]). Furthermore, it has been held that “[i]n 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).” See MPEP 2144.05(I). Applicant appears to have placed no criticality on the claimed range.
The modified invention of Futoshi and Field does not teach the optically transparent hollow microspheres having an effective hydrostatic pressure under which 10 volume % of the glass beads collapse is at least 3 megapascals; and a ratio of the volume of the optically transparent glass beads contained in the microparticle-containing portions is 5% to 20%.
However, Matsubara discloses “a hollow aluminosilicate glass microsphere comprising a glass composition containing no or substantially no alkali metal and having substantially no eluted amount of boron, and a method for producing the same” ([0001]) and an effective hydrostatic pressure according to 90% yield pressure resistance under which 10 volume % of the glass beads collapse being at least 3 megapascals (MPa) (“a fracture strength of at least 50 MPa at the time when 10% volume is reduced based on volume under hydrostatic pressure”, [0020], [0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the optically transparent hollow glass microspheres of Futoshi and Field to incorporate an effective hydrostatic pressure under which 10 volume % of the glass beads collapse being at least 3 megapascals, as taught by Matsubara, for the benefit of preventing the “fractur[ing] at the time of preparing a compound or during” use (Matsubara: [0020]).
The modified invention of Futoshi, Field and Matsubara does not teach a ratio of the volume of the optically transparent hollow glass beads contained in the microparticle-containing portions is 5% to 20%.
However, Qiao discloses “density, thermal conductivity, and compressive properties of hollow glass microsphere (HGM)-filled epoxy composites were investigated” and teaches a ratio of the volume of the optically transparent hollow glass beads contained in the microparticle-containing portions is 5% to 20% (Figure 2b depicts 10 volume % hollow glass microsphere (HGM) to epoxy and Figure 2c depicts 20 volume % HGM to epoxy). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embryo transfer tool of Futoshi, Field and Matsubara such that a ratio of the volume of the optically transparent glass beads contained in the microparticle-containing portions being 5% to 20%, as taught by Qiao, for the benefit of adjusting the composition to the desired compressive modulus and strength needed for the user (page 1416, column 1, paragraph 4).
Regarding claim 13, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 11. Futoshi teaches the synthetic resin forming the first and second microparticle-containing synthetic resin portions (“a first bubble-containing surface layer” 13a, page 3, paragraph 2; Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2) is the same as the colorless and transparent synthetic resin (“polyolefin (polyethylene, polypropylene)”, page 3, paragraph 6 for “soft tube 11”; “polyolefin (for example, polyethylene, polypropylene”, page 6, paragraph 2 for “flexible tube 21”) forming the flexible tube (“flexible tube 21”, page 6, paragraph 2). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions and both flexible tube and soft tube from Futoshi can be from the same material and reads on the limitation “is same the colorless and transparent synthetic resin”.
Regarding claim 14, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 11. Futoshi teaches the synthetic resin forming the first and second microparticle-containing synthetic resin portions has higher flexibility than the colorless and transparent synthetic resin forming the flexible tube (“flexible tube 21”, page 6, paragraph 2) (“As a material for forming the flexible tube 21, a material that is harder than the soft tube 11 and has a certain degree of shape retention and flexibility is used.”, page 6, paragraph 2). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions (page 6, paragraph 7) and that harder material has less flexibility.
Regarding claim 15, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 11. Futoshi teaches the first and second microparticle-containing synthetic resin portions (respectively, “a first bubble-containing surface layer” 13a, page 3, paragraph 2, Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2) have a flexibility that is equivalent to flexibility of the synthetic resin forming the flexible tube (21) ((“polyolefin (polyethylene, polypropylene)”, page 3, paragraph 6 for “soft tube 11”; “polyolefin (for example, polyethylene, polypropylene”, page 6, paragraph 2 for “flexible tube 21”). Examiner interprets the soft tube contains the first and second microparticle-containing synthetic resin portions and both flexible tube and soft tube from Futoshi can be from the same material and reads on the limitation “has flexibility that is equivalent to flexibility”.
Regarding claim 16, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 11. Futoshi teaches the embryo transfer tool (“instrument 1 for embryo transplantation”, abstract) and the first and second microparticle-containing portions (respectively, “a first bubble-containing surface layer” 13a, page 3, paragraph 2, Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2). Futoshi does not teach the embryo transfer tool including, at a distal end portion thereof, an annular transparent distal end portion that does not include the microparticle-containing portions.
However, Field discloses an “embryo replacement catheter has a flexible extruded shaft of a transparent polyurethane with a bore extending along its length” and teaches the embryo transfer tool (“embryo replacement catheter”, abstract) includes, at a distal end portion thereof, an annular transparent (“clear, transparent polyurethane material”, [0018]) distal end portion that does not include microparticle-containing portions (“the outer surface of the device may be smooth and uninterrupted by gas bubbles, and the device may have an inner surface that is smooth and uninterrupted by gas bubbles”, [0007]; Figure 2). Examiner interprets that the outer surface and inner surface are uninterrupted by gas bubbles as well as at the distal end. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the embryo transfer tool of Futoshi to incorporate at a distal end portion thereof, an annular transparent distal end portion that does not include microparticle-containing portions, as taught by Field, for the benefit of preventing abrasions in patient’s and/or healthcare professional’s body when in use.
Regarding claim 17, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 11. Futoshi teaches a thickness of each of the first and second microparticle-containing synthetic resin portions is 1/5 to 1/3 of a thickness of the flexible tube (“flexible tube 21”, page 6, paragraph 2) (“thickness of the first and second bubble-containing surface layers is 1/5 to 1/3 of the thickness of the soft tube” page 6, paragraph 8).
Regarding claim 18, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 11. Futoshi teaches a width of each of the first and second microparticle-containing synthetic resin portions is at least 30/100 of an outer circumferential length of the flexible tube (“the width of the first and second colorless and transparent portions is 30/100 or more of the outer peripheral length of the soft tube”, page 6, paragraph 7).
Regarding claim 19, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 11. Futoshi teaches an embryo transfer device (“embryo transfer device 10”, page 5, paragraph 8) comprising:
the embryo transfer tool (“instrument 1 for embryo transplantation”, abstract) according to claim 11,
the flexible tube (“flexible tube 21”, page 6, paragraph 2) being a first flexible tube (21); and
a sheath (“sheath” 2, page 5, paragraph 9) that includes a second flexible tube (“soft tube” 11, page 5, paragraph 9) that is a material harder than a material of the first flexible tube (21) of the embryo transfer tool (1) and a sheath hub (“sheath hub” 22, page 5, paragraph 7) that is provided at a proximal end of the second flexible tube (11), the sheath (2) accommodating the first flexible tube (21) with the distal end portion of the first flexible tube (21) projecting from the sheath (2) (Figure 7).
Regarding claim 20, Futoshi, Field, Matsubara and Qiao teach all limitations of claim 19. Futoshi teaches a portion of the first flexible tube (“flexible tube 21”, page 6, paragraph 2) projects from a distal end of the sheath (2), at least a part of the portion of the first flexible tube (21) that projects from the distal end of the sheath (2) including the first and second microparticle-containing synthetic resin portions (“a first bubble-containing surface layer” 13a, page 3, paragraph 2; Figure 1; “second bubble-containing surface layer” 13b, page 3, paragraph 2).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Futoshi, Field, Matsubara and Qiao, as applied in claim 11, in view of Ogura (US 20100036201 A1).
Regarding claim 12, Futoshi, Field and Matsubara teach all limitations of claim 11. Futoshi teaches the first and second microparticle-containing synthetic resin portions (respectively, 13a and 13b, page 3, paragraph 2) and optically clear hollow beads (“bubbles”, page 3, paragraph 3) but does not teach the microparticle-containing synthetic resin portions contain 0.5-5 parts by weight of the optically transparent hollow glass beads per 100 parts by weight of the synthetic resin.
However, Ogura discloses “an endoscopic flexible tube, including a spiral tube, a mesh tube covering the spiral tube, and a sheath coating the outer surface of the mesh tube, the sheath being composed of a sheathing resin material containing closed cells” (abstract) and teaches the microparticle-containing synthetic resin portions (“sheathing material”, [0040]) contain 45 or less parts by weight of the optically transparent hollow glass beads (“hollow microspheres”, [0040]) per 100 parts by weight of the synthetic resin (“sheathing resin material”, [0040]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microparticle-containing synthetic resin portions of the embryo transfer tool of Futoshi such as a range of 0.5 - 5, as taught by Ogura, for the benefit of reducing the specific gravity of the sheath to increase its elasticity while preventing embrittlement. Furthermore, it has been held that “[i]n 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).” See MPEP 2144.05(I). Applicant appears to have placed no criticality on the claimed range.
Response to Arguments
Applicant's arguments, see page 15, filed 29 August 2025, with respect to the drawing objections have been fully considered and are all persuasive. The drawing objections regarding reference numeral “11” and “21” of 29 May 2025 have been withdrawn.
Applicant's arguments, see page 16, filed 29 August 2025, with respect to the claims objections have been fully considered and are all persuasive in light of the amendments. The claim objections for 9 and 11 of 29 May 2025 have been withdrawn.
Applicant's arguments, see page 16, filed 29 August 2025, with respect to 35 U.S.C. 112(b) rejections have been fully considered and are all persuasive in light of the amendments. The 35 U.S.C. 112(b) rejections for 1 - 20 of 29 May 2025 have been withdrawn.
Applicant's arguments, see page 16, filed 29 August 2025, with respect to 35 U.S.C. 112(d) rejections have been fully considered and are all persuasive in light of the amendments. The 35 U.S.C. 112(d) rejections for 4 – 5 and 14 - 15 of 29 May 2025 have been withdrawn.
Applicant’s arguments with respect to claim(s) 1 – 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. See rejections above.
Applicant's arguments, pages 17 – 18, filed 29 August 2025 have been fully considered but they are not persuasive. Applicant contends “the Examiner's interpretation is not supported by Field's paragraph [0007], which does not mention the distal end, or Field's Fig. 2, which, as explained in paragraph [0015], only shows part of the catheter and so does not show the distal end.”. However, Field teaches the embryo transfer tool (“embryo replacement catheter”, abstract) includes, at a distal end portion (“patient end 11” [0018] Figure 1) thereof, an annular transparent distal end portion (“patient end 11” [0018] Figure 1) that does not include the microparticle-containing portions, and the microparticles-containing portions are not exposed in the distal end surface of teaches the embryo transfer tool (“embryo replacement catheter”, abstract) (“The outer and inner surfaces 13 and 14 of the shaft may be smooth and uninterrupted by gas bubbles or the bubbles may break the surface.” [0018] Figures 1 and 2; Examiner interprets the distal end portion does not include and/or expose the microparticles-containing portions considering “the shaft may be smooth and uninterrupted by gas bubbles”.). See rejection above.
Applicant's arguments, pages 17 – 18, filed 29 August 2025 have been fully considered but they are not persuasive. Applicant contends “Field does not say anything about preventing abrasions”. However, it would have been obvious to one of ordinary skill in the art to modify the embryo transfer tool of Futoshi such that microparticles-containing portions are not exposed, as taught by Field, for the benefit of preventing abrasions and not harm the patient.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JULIE THI TRAN/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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