DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed 06 February 2026 has been entered. Claim(s) 1-42 remain pending in the application. Applicant’s amendments to the drawings and claims have overcome each and every objection to the drawings, and each and every rejection under 35 U.S.C. 112(b) previously set forth in the Office Action mailed 06 November 2025.
Claim Objections
Claim 39 is objected to because of the following informalities: "heat treated material treatment" should be --heat treated material --. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-14 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto (US 4925445) in view of Noriega (US 20060074442).
Regarding claim 1, Sakamoto discloses a guidewire (Figs. 1, 6A, guide wire 10), comprising:
an elongated tubular member (Fig. 1, guide wire 10 has an elongated body formed between a proximal end at body portion 11 and a distal end portion 12) having a proximal end (Fig. 1, proximal end nearest to body portion 11) and a distal end (Fig. 1, distal tip portion 14);
a proximal section extending from the proximal end toward the distal end (Fig. 1, body portion 11);
a distal section (Fig. 1, distal end portion 12, tapered portion 13, and distal tip 14 form a distal section) extending from the distal end (Fig. 1, distal tip portion 14) toward the proximal end (Fig. 1, extending toward the proximal end at body portion 11), the distal section having a tapered section (Fig. 1, tapered portion 13 is tapered) and a constant diameter section (Fig. 1, distal end portion 12 where the constant diameter is also shown by Fig. 4 of the cross section at IV) distal of the tapered section (Fig. 1, the distal end portion 12 is distal of the tapered portion 13);
a transition joint (Element “T” in annotated Fig. 6A, below), positioned between the tapered section (Fig. 6A, tapered portion 13) and the distal end (Fig. 1, distal tip portion 14); and
an extended U-shaped section (Fig. 6A, distal end portion 12A is formed in a U-shaped section) formed adjacent the transition joint (Fig. 6A, the U-shaped section of portion 12A is adjacent the transition joint “T” of the annotated Fig. 6A below).
PNG
media_image1.png
192
232
media_image1.png
Greyscale
Annotated Fig. 6A
Sakamoto additionally discloses wherein the distal section generally includes sections of differing flexibility along its length configured to facilitate prolapse of the constant diameter section and enable the constant diameter section to double back upon itself and promote formation of an extended U-shaped leading end on the guidewire adjacent the transition joint when a pressure or force is applied at the distal end while tracking in a vessel (Col. 3, line 26-28 and Col. 13, line 31-33--at least portions of the body portion and the distal end portion are formed of a super-elastic metallic member; Col. 7, line 20-25--while the distal end portion 12 goes through a bent portion of the blood vessel, a flexural deformation of a high value can be obtained under a load of a comparatively low value, and a curved deformation and its restoration are repeated).
While there is some reference to only a portion of the distal portion of Sakamoto being formed of super-elastic material such that the distal portion would have at least two sections of differing flexibility (e.g., one section super-elastic and one not), Sakamoto is silent as to where along the distal portion these sections would be found and thus cannot be relied upon to disclose wherein the constant diameter section has sections of differing flexibility along its length.
Noriega is in the field of a guidewire system (paragraph 0003) and teaches a guidewire (Fig. 3, guidewire 14; paragraph 0099), wherein the constant diameter section (Fig. 4, hypotube 37) has sections of differing flexibility along its length (Fig. 4, sections of the hypotube 37 have laser cuts; paragraph 0104-0105) in order to facilitate the desired flexibility and performance of the system (Paragraph 0103), wherein the sections of differing flexibility can occur at any portion of the constant diameter section (Paragraph 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto to include differing flexibility along the constant diameter section as taught by Noriega, the motivation being to maximize the flexibility of the guidewire (Noriega, paragraph 0104-0105 and Sakamoto, Col. 2, line 5-9).
Regarding claim 2, the combination of Sakamoto and Noriega discloses the guidewire of claim 1. Sakamoto further discloses wherein the extended U-shaped leading end extends from the constant diameter section (Fig. 6A, distal end portion 12A which forms the U-shaped leading end) to the distal end (Fig. 1, distal tip portion 14) with the transition joint positioned therebetween (Point “T” as shown in annotated Fig. 6A above is positioned between the distal end 14 and the tapered portion 13).
Regarding claim 3, the combination of Sakamoto and Noriega discloses the guidewire of claim 2. Sakamoto further discloses wherein the extended U-shaped leading end (Fig. 6A, the U-shaped leading end) has a first member having a first length (Annotated Fig. 6A, the first member indicated by “1”), a second member having a second length (Annotated Fig. 6A, the second member indicated by “2”), and a U-shaped bend joining the first member and second member (Annotated Fig. 6A, the U-shaped bend formed by joining first and second members 1 and 2).
Regarding claim 4, the combination of Sakamoto and Noriega discloses the guidewire of claim 3. Sakamoto further discloses wherein the U-shaped bend has an outer curve having an arc length (Annotated Fig. 6A, outer curve having arc length “A”) and a midpoint on the arc length (Annotated Fig. 6A, point indicated by “M").
Regarding claim 5, the combination of Sakamoto and Noriega discloses the guidewire of claim 4. Sakamoto further discloses wherein the first length of the first member (Annotated Fig. 6A, first member 1) extends from the distal end (Fig. 1, Fig. 6A, distal tip portion 14) to the midpoint (Annotated Fig. 6A midpoint “M”) on the arc length (Annotated Fig. 6A, the first length of the first member 1 extends from the distal tip portion 14 to the midpoint M on the arc length of the bend A), and the second length of the second member (Annotated Fig. 6A, second member 2) is equal to the first length of the first member (Annotated Fig. 6A, the second length of the second member 2 is equal to the first length of the first member 1).
Regarding claim 6, the combination of Sakamoto and Noriega discloses the guidewire of claim 5. Sakamoto further discloses wherein the second length of the second member (Annotated Fig. 6A, second member 2) extends from the midpoint of the arc length (Annotated Fig. 6A, midpoint M) and along the constant diameter section of the distal section (Annotated Fig. 6A, the second length of the second member 2 extends from the midpoint of the arc length M toward the tapered portion 13, along the distal end portion 12A which has a constant diameter).
Regarding claim 7, the combination of Sakamoto and Noriega discloses the guidewire of claim 6. Sakamoto additionally discloses that the length of the distal end portion 12 may be in a range between 1 and 50cm (Col. 5, line 30-42; equivalent to 0.39in. to 19.65in.), where this length encompasses the entire length of distal end portion 12, such that the length of the first member must be no more than half of this length (See annotated Fig. 6A, where the first member is the same length as the second member). As such, it may be seen that the length of the first member of Sakamoto may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to create a guidewire having the first length of the first member to be in a range from 0.07 inch to 2.5 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 8, the combination of Sakamoto and Noriega discloses the guidewire of claim 7. Sakamoto additionally discloses that the length of the distal end portion 12 may be in a range between 1 and 50cm (Col. 5, line 30-42; equivalent to 0.39in. to 19.65in.), where this length encompasses the entire length of distal end portion 12, such that the length of the second member must be no more than half of this length (See annotated Fig. 6A, where the first member is the same length as the second member). As such, it may be seen that the length of the second member of Sakamoto may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the second length of the second member to be in a range from 0.07 inch to 2.5 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 9, the combination of Sakamoto and Noriega discloses the guidewire of claim 8. Sakamoto additionally discloses that the length of the distal end portion 12 may be in a range between 1 and 50cm (Col. 5, line 30-42; equivalent to 0.39in. to 19.65in.), where this length encompasses the entire length of distal end portion 12, such that the length of the u-shaped leading end as measured longitudinally from most proximal to most distal points on the extended U-shaped leading end must be less than this total length (See annotated Fig. 6A, where the u-shaped section is comprised of the first and second members). As such, it may be seen that the length of the u-shaped section of Sakamoto may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the extended u-shaped member to have a length in a range from 0.07 inch to 2.5 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 10, the combination of Sakamoto and Noriega discloses the guidewire of claim 9. Sakamoto additionally discloses that the length of the distal end portion 12 may be in a range between 1 and 50cm (Col. 5, line 30-42; equivalent to 0.39in. to 19.65in.), where this length encompasses the entire length of distal end portion 12, such that length of the outer curve of the U-shaped bend and thus the radius of this bend must be smaller than the length of the entire distal end portion (See annotated Fig. 6A, where A shows the arc length of the outer curve of the U-shaped bend). As such, it may be seen that the length of the first member of Sakamoto may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the outer curve of the U-shaped bend to have a radius in a range from 0.01 inch to 0.17 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 11, the combination of Sakamoto and Noriega discloses the guidewire of claim 1.
Sakamoto additionally discloses wherein the constant diameter section has a weakened section adjacent to the transition joint (Col. 5, line 7-10-- a body portion 11 comparatively high in rigidity and a distal end portion 12 comparatively flexible, and a tapered portion 13 disposed therebetween; Col. 5, line 52-56-- the rigidity in a connecting portion between the body portion 11 and distal end portion 12 is moderately varied, so that breakage and bending of the guide wire 10 in this connecting portion can be prevented from occurring; Col. 7, line 21-25-- while the distal end portion 12 goes through a bent portion of the blood vessel, a flexural deformation of a high value can be obtained under a load of a comparatively low value, and a curved deformation and its restoration are repeated).
Sakamoto additionally discloses wherein the distal section generally includes sections of differing flexibility along its length configured to facilitate prolapse of the constant diameter section and enable the constant diameter section to double back upon itself and promote formation of an extended U-shaped leading end on the guidewire adjacent the transition joint when a pressure or force is applied at the distal end while tracking in a vessel (Col. 3, line 26-28 and Col. 13, line 31-33--at least portions of the body portion and the distal end portion are formed of a super-elastic metallic member; Col. 7, line 20-25--while the distal end portion 12 goes through a bent portion of the blood vessel, a flexural deformation of a high value can be obtained under a load of a comparatively low value, and a curved deformation and its restoration are repeated).
However, Sakamoto does not explicitly disclose that the weakened section is more flexible than adjacent portions of the constant diameter section.
Noriega is in the field of a guidewire system (paragraph 0003) and teaches a guidewire (Fig. 3, guidewire 14; paragraph 0099), wherein the constant diameter section (Fig. 4, hypotube 37) has a weakened section on the second member adjacent to the transition joint wherein the weakened section is more flexible than adjacent portions of the constant diameter section (Fig. 4, sections of the hypotube 37 have laser cuts; paragraph 0104-0105).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto to include a weakened section adjacent to less flexible sections in the constant diameter section as taught by Noriega, the motivation being to maximize the flexibility of the guidewire to prevent the guidewire from damaging the wall of a blood vessel and to adapt to the shape of meandering and complex vessels and vascular branching (Noriega, paragraph 0104-0105 and Sakamoto, Col. 2, line 5-9).
Regarding claim 12, the combination of Sakamoto and Noriega discloses the guidewire of claim 11. Sakamoto additionally generally teaches the weakened section is formed of heat treated material where the material is treated at a high temperature to make the material softer (Col. 9, line 26-30-- it is preferable to separate the body portion and the distal end portion in heat treatment, so that the restoring stress in the body portion can be high in value and the distal end portion flexible). Regarding wherein the weakened section is formed by heat treatment in a range from 350° C to 600° C for a time in a range from 30 seconds to 85 minutes on the second member adjacent to the transition joint, the weakened section formed by heat treatment does not structurally limit the claim. The novelty of a product does not depend on its method of production. If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the weakened section in any manner for the purpose of setting a shape of the section in order to predictably facilitate curving the guidewire, thereby facilitating conforming to vascular anatomy.
Regarding claim 13, the combination of Sakamoto and Noriega discloses the guidewire of claim 12. Sakamoto additionally discloses wherein the constant diameter section is formed from a superelastic material (Col. 8, line 1-5-- only the distal end portion of the guide wire is formed of the super-elastic metallic member, and further, provided with an elastic strain characteristic capable of being displaced to a comparatively high extent under a given stress and restorable.).
Regarding claim 14, the combination of Sakamoto and Noriega discloses the guidewire of claim 13. Sakamoto additionally discloses wherein the superelastic material is Nitinol (Col. 5, line 11-13-- The aforesaid guide wire 10 is generally formed of a super-elastic (pseudo-elastic) metallic member such as a TiNi alloy of 49.about.58 atom % N).
Regarding claim 39, the combination of Sakamoto and Noriega discloses the guidewire of claim 12. Regarding wherein the heat treated material treatment is applied to multiple sections of the constant diameter section, the application of heat treatment does not structurally limit the claim. As noted above, Sakamoto generally teaches that at least a portion of the constant diameter section may be more flexible than the rest and that more flexible sections of the device may be made by using heat treated material. The novelty of a product does not depend on its method of production: "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.". If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the constant diameter sections in any manner for the purpose of setting a shape of the section. See MPEP 2113 regarding product-by-process claims.
Claim(s) 10-14 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto in view of Noriega, further in view of Kurth (US 20130296911 A1).
Regarding claim 10, the combination of Sakamoto and Noriega discloses the guidewire of claim 9. Sakamoto additionally discloses that the length of the distal end portion 12 may be in a range between 1 and 50cm (Col. 5, line 30-42; equivalent to 0.39in. to 19.65in.), where this length encompasses the entire length of distal end portion 12, such that length of the outer curve of the U-shaped bend and thus the radius of this bend must be smaller than the length of the entire distal end portion (See annotated Fig. 6A, where A shows the arc length of the outer curve of the U-shaped bend).
Sakamoto does not explicitly state that the outer curve of the U-shaped bend has a radius in a range from 0.01 inch to 0.17 inch.
Kurth, in the same field of endeavor of a guidewire having a u-shaped distal segment, discloses a guidewire having a distal section including a U-shaped extended section with a U-shaped bend, wherein the outer curve of the U-shaped bend has a radius in a range from 0.01 inch to 0.17 inch (Paragraph 0070-- the radius "B" of the loop that forms the curved configuration can be about 0.125 inches; paragraph 0111-- Referring now to FIG. 12, an enlarged view of the end section 226 and distal section 228 is illustrated. According to an exemplary embodiment, the distal curve 226a is formed by an arcuate or bent or angled portion of the distal section 226. The distal section 226, for example, may be heat curved or bent so that the curve diameter [E] of the proximal curve 226a is about 8 mm with a +/-1 mm tolerance, for example. It is contemplated that the curve diameter [E] may be more or less than 8 mm to accommodate adult and pediatric or other uses of transseptal guidewire 220).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the guidewire of Sakamoto to utilize the particular dimensions of Kurth in order to predictably improve the ability of the guidewire to be used in vascular and/or pediatric anatomy (see Kurth, paragraph 0111).
Regarding claim 11, the combination of Sakamoto, Noriega, and Kurth discloses the guidewire of claim 10. Sakamoto additionally discloses wherein the constant diameter section has a weakened section adjacent to the transition joint (Col. 5, line 7-10-- a body portion 11 comparatively high in rigidity and a distal end portion 12 comparatively flexible, and a tapered portion 13 disposed therebetween; Col. 5, line 52-56-- the rigidity in a connecting portion between the body portion 11 and distal end portion 12 is moderately varied, so that breakage and bending of the guide wire 10 in this connecting portion can be prevented from occurring; Col. 7, line 21-25-- while the distal end portion 12 goes through a bent portion of the blood vessel, a flexural deformation of a high value can be obtained under a load of a comparatively low value, and a curved deformation and its restoration are repeated).
Sakamoto additionally discloses wherein the distal section generally includes sections of differing flexibility along its length configured to facilitate prolapse of the constant diameter section and enable the constant diameter section to double back upon itself and promote formation of an extended U-shaped leading end on the guidewire adjacent the transition joint when a pressure or force is applied at the distal end while tracking in a vessel (Col. 3, line 26-28 and Col. 13, line 31-33--at least portions of the body portion and the distal end portion are formed of a super-elastic metallic member; Col. 7, line 20-25--while the distal end portion 12 goes through a bent portion of the blood vessel, a flexural deformation of a high value can be obtained under a load of a comparatively low value, and a curved deformation and its restoration are repeated).
However, Sakamoto does not explicitly disclose that the weakened section is more flexible than adjacent portions of the constant diameter section.
Noriega is in the field of a guidewire system (paragraph 0003) and teaches a guidewire (Fig. 3, guidewire 14; paragraph 0099), wherein the constant diameter section (Fig. 4, hypotube 37) has a weakened section on the second member adjacent to the transition joint wherein the weakened section is more flexible than adjacent portions of the constant diameter section (Fig. 4, sections of the hypotube 37 have laser cuts; paragraph 0104-0105).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto to include a weakened section adjacent to less flexible sections in the constant diameter section as taught by Noriega, the motivation being to maximize the flexibility of the guidewire to prevent the guidewire from damaging the wall of a blood vessel and to adapt to the shape of meandering and complex vessels and vascular branching (Noriega, paragraph 0104-0105 and Sakamoto, Col. 2, line 5-9).
Regarding claim 12, the combination of Sakamoto, Noriega and Kurth discloses the guidewire of claim 11. Sakamoto additionally generally teaches the weakened section is formed of heat treated material where the material is treated at a high temperature to make the material softer (Col. 9, line 26-30-- it is preferable to separate the body portion and the distal end portion in heat treatment, so that the restoring stress in the body portion can be high in value and the distal end portion flexible). Regarding wherein the weakened section is formed by heat treatment in a range from 350° C to 600° C for a time in a range from 30 seconds to 85 minutes on the second member adjacent to the transition joint, the weakened section formed by heat treatment does not structurally limit the claim. The novelty of a product does not depend on its method of production. If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the weakened section in any manner for the purpose of setting a shape of the section in order to predictably facilitate curving the guidewire, thereby facilitating conforming to vascular anatomy.
Regarding claim 13, the combination of Sakamoto, Noriega, and Kurth discloses the guidewire of claim 12. Sakamoto additionally discloses wherein the constant diameter section is formed from a superelastic material (Col. 8, line 1-5-- only the distal end portion of the guide wire is formed of the super-elastic metallic member, and further, provided with an elastic strain characteristic capable of being displaced to a comparatively high extent under a given stress and restorable.).
Kurth additionally discloses a constant diameter section is formed from a superelastic material (Fig. 3, end section 36; paragraph 0060-0061—nitinol). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto to be formed from nitinol as taught by Kurth to predictably improve the ability to shape the guidewire to facilitate steering and maneuverability.
Regarding claim 14, the combination of Sakamoto, Noriega, and Kurth discloses the guidewire of claim 13. Sakamoto additionally discloses wherein the superelastic material is Nitinol (Col. 5, line 11-13-- The aforesaid guide wire 10 is generally formed of a super-elastic (pseudo-elastic) metallic member such as a TiNi alloy of 49.about.58 atom % N).
Kurth additionally discloses a constant diameter section is formed from a superelastic material (Fig. 3, end section 36; paragraph 0060-0061—nitinol). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto to be formed from nitinol as taught by Kurth to predictably improve the ability to shape the guidewire to facilitate steering and maneuverability.
Regarding claim 39, the combination of Sakamoto, Noriega and Kurth discloses the guidewire of claim 12. Regarding wherein the heat treated material treatment is applied to multiple sections of the constant diameter section, the application of heat treatment does not structurally limit the claim. As noted above, Sakamoto generally teaches that at least a portion of the constant diameter section may be more flexible than the rest and that more flexible sections of the device may be made by using heat treated material. The novelty of a product does not depend on its method of production: "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.". If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the constant diameter sections in any manner for the purpose of setting a shape of the section. See MPEP 2113 regarding product-by-process claims.
Claim(s) 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto in view of Noriega, further in view of Euteneuer (US 7824345 B2).
Regarding claim 15, the combination of Sakamoto and Noriega discloses the guidewire of claim 11. However, Sakamoto does not explicitly disclose wherein the weakened section is formed by any of a notch, an hourglass-shaped section, a groove, a U-shaped section, or a V-shaped section in the constant diameter section positioned adjacent to the transition joint.
Euteneuer, in the same field of endeavor of a guidewire having improved flexibility characteristics (Col. 1, line 5-8), discloses a guidewire having a weakened section formed by any of a notch, an hourglass-shaped section, a groove, a U-shaped section, or a V-shaped section in the second member positioned adjacent to the transition joint (Col. 6, line 28-54-- intermediate portion 120 having one or more cuts or notches 122 formed therein. Notches 122 can decrease the column strength and/or increase the flexibility of intermediate portion 120 so that at least a portion thereof can buckle if distal tip 21 encounters, for example, an occlusion… although notches 122 are depicted as being squared in shape in FIG. 4, it can be appreciated that the shape, arrangement, and/or configuration of notches 122 can be altered without departing from the spirit of the invention. For example, notches may be rounded in shape…). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto and Noriega, including differing flexibilities within the constant diameter section, to include notches, grooves, or sections as described by Euteneuer in order to predictably improve flexibility of the tip of the device (Col. 6, line 55-67).
Regarding claim 16, the combination of Sakamoto and Noriega discloses the guidewire of claim 11. The combination of Sakamoto and Noriega discloses a guidewire having a constant diameter section including a weakened section which is more flexible than adjacent portions of the constant diameter section as described above.
However, Sakamoto does not explicitly disclose wherein the weakened section is formed by attaching a ribbon member to the constant diameter section in an overlapping manner proximal to the transition joint so that a portion of the constant diameter section distal of the ribbon is weaker and more easily bendable.
Euteneuer, in the same field of endeavor of a guidewire having improved flexibility characteristics (Col. 1, line 5-8), discloses a guidewire having a weakened section formed by attaching a ribbon member to a portion adjacent to a transition joint (Col. 7, line 24-26 and line 37-38-- Coil 224 may be formed of round wire or flat ribbon ranging in dimensions to achieve the desired characteristics, such as flexibility… Coil 224 may include a proximal end 226 that is coupled to or otherwise attached to proximal portion 16). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto and Noriega to include a ribbon as described by Euteneuer as an alternative means to provide predictably improved flexibility of the tip of the device (Col. 6, line 55-67) which would enable the guidewire to pass through a vessel without damaging the vessel walls as well as enabling navigation of branching or complex vessels.
Claim(s) 19-20 and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto in view of Noriega, further in view of Dant (US 20190030300 A1).
Regarding claim 19, the combination of Sakamoto and Noriega discloses the guidewire of claim 10.
Sakamoto additionally discloses wherein the constant diameter section has a weakened section adjacent to the transition joint (Col. 5, line 7-10-- a body portion 11 comparatively high in rigidity and a distal end portion 12 comparatively flexible, and a tapered portion 13 disposed therebetween; Col. 5, line 52-56-- the rigidity in a connecting portion between the body portion 11 and distal end portion 12 is moderately varied, so that breakage and bending of the guide wire 10 in this connecting portion can be prevented from occurring; Col. 7, line 21-25-- while the distal end portion 12 goes through a bent portion of the blood vessel, a flexural deformation of a high value can be obtained under a load of a comparatively low value, and a curved deformation and its restoration are repeated), such that a section near the weakened section may be considered relatively strengthened.
Sakamoto additionally discloses wherein the distal section generally includes sections of differing flexibility along its length configured to facilitate prolapse of the constant diameter section and enable the constant diameter section to double back upon itself and promote formation of an extended U-shaped leading end on the guidewire adjacent the transition joint when a pressure or force is applied at the distal end while tracking in a vessel (Col. 3, line 26-28 and Col. 13, line 31-33--at least portions of the body portion and the distal end portion are formed of a super-elastic metallic member; Col. 7, line 20-25--while the distal end portion 12 goes through a bent portion of the blood vessel, a flexural deformation of a high value can be obtained under a load of a comparatively low value, and a curved deformation and its restoration are repeated) such that the constant diameter section includes portions which are weakened and strengthened relative to one another and correspondingly are more flexible and stiffer, respectively.
However, Sakamoto does not explicitly disclose wherein the constant diameter section has a strengthened section proximal to the transition joint that is stiffer than adjacent portions of the constant diameter section distal to the strengthened section.
Dant, in the same field of endeavor of a medical guidewire, discloses a guidewire having a constant diameter section including a strengthened section (Paragraph 0016-20-- In one embodiment, resilient portion 14 overlaps core wire 12 in a distal tip section 13 of guidewire 10). It would have been obvious ton one having ordinary skill in the art at the time of filing to modify the guidewire of Sakamoto to utilize a strengthened section as disclosed by Dant proximal to the transition joint in order to predictably improve the pushability and handling of the tip of the device (see Dant, paragraph 0018-0019). Such a goal is further supported by the disclosure of Sakamoto which describes that a guidewire must include flexibility to allow for navigation of complex anatomy and reducing damage to vessel walls while retaining strength to make the guidewire readily insertable (Sakamoto Col. 2, line 64-Col. 3, line 11).
Regarding claim 20, the combination of Sakamoto, Noriega, and Dant discloses the guidewire of claim 19. Sakamoto additionally generally teaches heat treated material treated at different temperatures depending on the required strength and flexibility of the given portion (Col. 9, line 26-30-- it is preferable to separate the body portion and the distal end portion in heat treatment, so that the restoring stress in the body portion can be high in value and the distal end portion flexible). Regarding wherein the strengthened section is formed by heat treatment in a range from 250° C to 450° C for a time in range from 2 minutes to 45 minutes on the second member at a point adjacent to the transition joint, the application of heat treatment does not structurally limit the claim. The novelty of a product does not depend on its method of production: "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.". If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the constant diameter sections in any manner for the purpose of setting a shape of the section. See MPEP 2113 regarding product-by-process claims.
Regarding claim 40, the combination of Sakamoto, Noriega, and Dant discloses the guidewire of claim 20. Regarding wherein the heat treated material treatment is applied to multiple sections of the constant diameter section, the application of heat treatment does not structurally limit the claim. As noted above, Sakamoto generally teaches that at least a portion of the constant diameter section may be more flexible than the rest and that more flexible sections of the device may be made by using heat treated material. The novelty of a product does not depend on its method of production: "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.". If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the constant diameter sections in any manner for the purpose of setting a shape of the section. See MPEP 2113 regarding product-by-process claims.
Claim(s) 21-34 and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth (US 20130296911 A1) in view of Noriega.
Regarding claim 21, Kurth discloses a guidewire (Fig. 3-6, guidewire 20), comprising:
an elongated tubular member (Fig. 3-6, guidewire 20 defines an elongated tubular member) having a proximal end (Fig. 6, guidewire 20 includes a proximal end shown nearest to portion 21/21a) and a distal end (Fig. 3-6, tip 29);
a proximal section extending from the proximal end toward the distal end (Fig. 4A, proximal portion 21a);
a distal section extending from the distal end toward the proximal end (Fig. 3, Fig. 4A, portion 24a and end section 26 define the distal section), the distal section having a tapered section (Fig. 4A-4B, circled tapered transition; paragraph 0065) and a flattened wire section (Fig. 3, end section 26; paragraph 0072-0074-- end section 26 is ovalized or pressed or otherwise formed from a portion (24a, FIG. 4a) of elongate body (22a, FIG. 4a) such that end section 26 has a substantially non-circular cross-section) distal of the tapered section (Fig. 3, Fig. 4A, Fig. 4B, end section 26 is distal to the tapered transition; paragraph 0065); and
a transition joint (Fig. 3, joint shown distal of marker 25; Fig. 6, joint is shown at the point where the end section 26 curves away from the axis 1, see “T” in annotated Fig. 6 below) positioned between the tapered section (Fig. 3, Fig. 4A, Fig. 4B, the tapered transition) and the distal end (Fig. 3, tip 29); and
wherein the flattened wire section is configured to prolapse and double back upon itself and promote formation of an extended U-shaped leading end of the guidewire adjacent the transition joint when a pressure or force is applied at the distal end while tracking in a vessel (Fig. 3-6, end section 26 is U-shaped; Paragraph 0081-0082).
PNG
media_image2.png
284
292
media_image2.png
Greyscale
Annotated Fig. 6
However, Kurth does not explicitly disclose wherein the flattened wire section has sections of differing flexibility along its length to facilitate the prolapse and doubling back of the flattened wire section.
Noriega is in the field of a guidewire system (paragraph 0003) and teaches a guidewire (Fig. 3, guidewire 14; paragraph 0099), wherein the constant diameter section (Fig. 4, hypotube 37) has sections of differing flexibility along its length (Fig. 4, sections of the hypotube 37 have laser cuts; paragraph 0104-0105) in order to facilitate the desired flexibility and performance of the system (Paragraph 0103), wherein the sections of differing flexibility can occur at any portion of the constant diameter section (Paragraph 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Kurth to include differing flexibility along the constant diameter section as taught by Noriega, the motivation being to maximize the flexibility of the guidewire (Noriega, paragraph 0104-0105 and Kurth, paragraphs 0081-0082).
Regarding claim 22, the combination of Kurth and Noriega disclose the guidewire of claim 21. Kurth further discloses wherein the extended U-shaped leading end extends from the flattened wire section (Fig. 6, distal end portion 26 which forms the U-shaped section) to the distal end (Distal tip 29) with the transition joint positioned therebetween (Point “T” as shown in annotated Fig. 6 above is positioned between the distal end 29 and the tapered portion Fig. 4B).
Regarding claim 23, the combination of Kurth and Noriega disclose the guidewire of claim 22. Kurth further discloses wherein the extended U-shaped leading end (Fig. 6, the U-shaped section) has a first member having a first length (Annotated Fig. 6, the first member indicated by “F”), a second member having a second length (Annotated Fig. 6, the second member indicated by “S”), and a U-shaped bend joining the first member and second member (Annotated Fig. 6, the U-shaped bend formed by joining first and second members F and S).
Regarding claim 24, the combination of Kurth and Noriega disclose the guidewire of claim 23. Kurth further discloses wherein the U-shaped bend has an outer curve having an arc length (Annotated Fig. 6, outer curve having arc length “A”) and a midpoint on the arc length (Annotated Fig. 6, point indicated by “M").
Regarding claim 25, the combination of Kurth and Noriega disclose the guidewire of claim 24. Kurth further discloses wherein the first length of the first member (Annotated Fig. 6, first member F) extends from the distal end (Fig. 3, Fig. 6, distal tip portion 29) to the midpoint (Annotated Fig. 6 midpoint “M”) on the arc length (Annotated Fig. 6, the first length of the first member F extends from the distal tip 29 to the midpoint M on the arc length of the bend A), and the second length of the second member (Annotated Fig. 6, second member S) is equal to the first length of the first member (Annotated Fig. 6, the second length of the second member S is equal to the first length of the first member F).
Regarding claim 26, the combination of Kurth and Noriega disclose the guidewire of claim 25. Kurth further discloses wherein the second length of the second member (Annotated Fig. 6, second member S) extends from the midpoint of the arc length (Annotated Fig. 6, midpoint M) and along the flattened wire section of the distal section (Annotated Fig. 6, the second length of the second member S extends from the midpoint of the arc length M toward the tapered portion of Fig. 4B, along the distal portion 24a and 26 which include a flattened wire section; see also Fig. 10 and paragraph 0088).
Regarding claim 27, the combination of Kurth and Noriega the guidewire of claim 26. Kurth additionally discloses that the length of the distal end portion 26 may be about 2cm or 0.79in (Paragraph 0105--the linear length of the distal section 228 and end section 226 (i.e., from the perforating tip 229 to the beginning of the radiopaque coil 225) may be about 2 cm NOTE that this section corresponds to end section 26 of Figs. 3-6, see paragraph 0088), where this length encompasses the entire length of distal end portion 24a and 26, such that the length of the first member must be no more than half of this length (See annotated Fig. 6A, where the first member is the same length as the second member). As such, it may be seen that the length of the first member of Kurth may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date to create a guidewire having the first length of the first member to be in a range from 0.07 inch to 2.5 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 28, the combination of Kurth and Noriega the guidewire of claim 27. Kurth additionally discloses that the length of the distal end portion 26 may be about 2cm or 0.79in (Paragraph 0105--the linear length of the distal section 228 and end section 226 (i.e., from the perforating tip 229 to the beginning of the radiopaque coil 225) may be about 2 cm NOTE that this section corresponds to end section 26 of Figs. 3-6, see paragraph 0088), such that the length of the second member must be no more than half of this length (See annotated Fig. 6, where the first member is the same length as the second member). As such, it may be seen that the length of the second member of Kurth may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the second length of the second member to be in a range from 0.07 inch to 2.5 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 29, the combination of Kurth and Noriega the guidewire of claim 28. Kurth additionally discloses that the length of the distal end portion 26 may be about 2cm or 0.79in (Paragraph 0105--the linear length of the distal section 228 and end section 226 (i.e., from the perforating tip 229 to the beginning of the radiopaque coil 225) may be about 2 cm NOTE that this section corresponds to end section 26 of Figs. 3-6, see paragraph 0088), such that the length of the u-shaped section must be less than this total length (See annotated Fig. 6A, where the u-shaped section is comprised of the first and second members). As such, it may be seen that the length of the u-shaped leading end as measured longitudinally from most proximal to most distal points on the U-shaped leading end of Kurth may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the extended u-shaped member to have a length in a range from 0.07 inch to 2.5 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 30, the combination of Kurth and Noriega discloses the guidewire of claim 29. Kurth additionally discloses wherein the outer curve of the U-shaped bend has a radius in a range from 0.01 inch to 0.17 inch (Paragraph 0070-- the radius "B" of the loop that forms the curved configuration can be about 0.125 inches; paragraph 0111-- Referring now to FIG. 12, an enlarged view of the end section 226 and distal section 228 is illustrated. According to an exemplary embodiment, the distal curve 226a is formed by an arcuate or bent or angled portion of the distal section 226. The distal section 226, for example, may be heat curved or bent so that the curve diameter [E] of the proximal curve 226a is about 8 mm with a +/-1 mm tolerance, for example. It is contemplated that the curve diameter [E] may be more or less than 8 mm to accommodate adult and pediatric or other uses of transseptal guidewire 220). As such, it may be seen that the length of the u-shaped section of Kurth may overlap with the claimed range of lengths. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date for the outer curve of the U-shaped bend has a radius in a range from 0.01 inch to 0.17 inch, as where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art and this sizing would facilitate conforming to vascular anatomy and/or pediatric anatomy which would necessitate a small size of guidewire.
Regarding claim 31, the combination of Kurth and Noriega discloses the guidewire of claim 21. Noriega is in the field of a guidewire system (paragraph 0003) and teaches a guidewire (Fig. 3, guidewire 14; paragraph 0099), wherein a constant diameter section (Fig. 4, hypotube 37) includes a portion which is a weakened section more flexible than adjacent portions of the constant diameter section (Fig. 4, sections of the hypotube 37 have laser cuts; paragraph 0104-0105) in order to facilitate the desired flexibility and performance of the system (Paragraph 0103), wherein the sections of differing flexibility can occur at any portion of the constant diameter section (Paragraph 0104).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Kurth to include differing flexibility along the flattened wire section adjacent to the transition joint as taught by Noriega, the motivation being to maximize the flexibility of the guidewire (Noriega, paragraph 0104-0105 and Kurth, paragraphs 0081-0082).
Regarding claim 32, the combination of Kurth and Noriega discloses the guidewire of claim 31. Kurth additionally generally teaches the weakened section is formed of heat treated material to make the material softer (Paragraph 0069-- end section 26 of transseptal guidewire 20 is biased to a curved configuration by a heat curving process or other forming process. For example, end section 26 may be treated at an elevated temperature, such as about 500 degrees Centigrade, for a set duration, such as about 10 seconds, to curve an otherwise linear superelastic nitinol wire.). Regarding wherein the weakened section is formed by heat treatment in a range from 350° C to 600° C for a time in a range from 30 seconds to 85 minutes on the second member adjacent to the transition joint, the weakened section formed by heat treatment does not structurally limit the claim. The novelty of a product does not depend on its method of production. If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the weakened section in any manner for the purpose of setting a shape of the section in order to predictably facilitate curving the guidewire, thereby facilitating conforming to vascular anatomy.
Regarding claim 33, the combination of Kurth and Noriega discloses the guidewire of claim 32. Kurth additionally discloses a constant diameter section is formed from a superelastic material (Fig. 3, end section 36; paragraph 0060-0061—nitinol). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto to be formed from nitinol as taught by Kurth to predictably improve the ability to shape the guidewire to facilitate steering and maneuverability.
Regarding claim 34, the combination of Kurth and Noriega discloses the guidewire of claim 33. Kurth additionally discloses wherein the superelastic material is Nitinol (Fig. 3, end section 36; paragraph 0060-0061—nitinol). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the guide wire of Sakamoto to be formed from nitinol as taught by Kurth to predictably improve the ability to shape the guidewire to facilitate steering and maneuverability.
Regarding claim 41, the combination of Kurth and Noriega discloses the guidewire of claim 32. Regarding wherein the heat treated material is applied to multiple sections of the constant diameter sections, the application of heat treatment does not structurally limit the claim. The novelty of a product does not depend on its method of production: "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.". If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the constant diameter sections in any manner for the purpose of setting a shape of the section. See MPEP 2113 regarding product-by-process claims.
Claim(s) 37-38 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kurth in view of Noriega, further in view of Dant (US 20190030300 A1).
Regarding claim 37, the combination of Kurth and Noriega discloses the guidewire of claim 30. However, Kurth does not explicitly disclose wherein the constant diameter section has a strengthened section on the second member and adjacent the transition joint.
Dant, in the same field of endeavor of a medical guidewire, discloses a guidewire having a constant diameter section including a strengthened section (Paragraph 0016-20-- In one embodiment, resilient portion 14 overlaps core wire 12 in a distal tip section 13 of guidewire 10). It would have been obvious ton one having ordinary skill in the art at the time of filing to modify the guidewire of Kurth to utilize a strengthened section as disclosed by Dant on the second member and adjacent the transition joint in order to predictably improve the pushability and handling of the tip of the device (see Dant, paragraph 0018-0019).
Regarding claim 38, the combination of Kurth, Noriega, and Dant discloses the guidewire of claim 37. Kurth additionally generally teaches a section can be heat treated at a temperature to affect the flexibility or stiffness of the section (Paragraph 0069-- end section 26 of transseptal guidewire 20 is biased to a curved configuration by a heat curving process or other forming process. For example, end section 26 may be treated at an elevated temperature, such as about 500 degrees Centigrade, for a set duration, such as about 10 seconds, to curve an otherwise linear superelastic nitinol wire). Regarding wherein the strengthened section is formed by heat treatment in a range from 250° C to 450° C for a time in range from 2 minutes to 45 minutes on the second member at a point adjacent to the transition joint, the application of heat treatment does not structurally limit the claim. The novelty of a product does not depend on its method of production: "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.". If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the constant diameter sections in any manner for the purpose of setting a shape of the section. See MPEP 2113 regarding product-by-process claims.
Regarding claim 42, the combination of Kurth, Noriega, and Dant discloses the guidewire of claim 38. Regarding wherein the heat treatment is applied to multiple sections of the constant diameter sections, the application of heat treatment does not structurally limit the claim. The novelty of a product does not depend on its method of production: "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes.". If the product in the claim is the same as a product in the prior art, the claim is distinguishable even through the prior art was made by a different process. It would have been obvious to form the constant diameter sections in any manner for the purpose of setting a shape of the section. See MPEP 2113 regarding product-by-process claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-6 being rejected under 35 U.S.C. 102 to Sakamoto and claims 21-26 being rejected under 35 U.S.C. 102 to Kurth 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.
Specifically, newly cited Noriega has been provided to disclose the argued limitations of claims 1 and 21. While Applicant cites portions of Sakamoto and Kurth to argue that both references recite prevention of buckling of the guidewire, Sakamoto provides for a guidewire which may buckle and be restored to an original state (Col. 3, line 3-6). Kurth additionally provides for a guidewire which is flexible and bends to prevent perforation of a vessel wall (Paragraphs 0081-0082) and which returns to a shape after any such bending or buckling (Paragraph 0083-0085). Accordingly, each reference appears sufficient to be modified according to the teachings of Noriega to include sections of differing flexibility to support this bending and return to shape, as the current claim language does not preclude the guidewire from returning to an alternate shape after the claimed doubling back upon itself.
Applicant’s arguments with respect to the rejection of the claims under 35 U.S.C. 103 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.
Noriega is additionally used to support the rejections under 35 U.S.C. 103, including claim 11 as Noriega recites a weakened section which is a portion of a constant diameter section. As noted above, Sakamoto additionally supports the formation of only a portion of a distal section being weakened (and, as a result, other portions being relatively strengthened), such that the combination may be seen to disclose the claimed limitations. As each of Sakamoto and Kurth teaches the use of heat treating material to create sections having different flexibility by using different temperature ranges and Noriega supports the formation of a particular portion of the constant diameter section having a different strength, the related claims remain rejected.
Allowable Subject Matter
Claims 17-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the most pertinent prior art of the record, Sakamoto and Kurth (cited above) fail to disclose wherein the weakened section is formed by positioning a flexible joint adjacent the transition joint or wherein the weakened section is formed by positioning a bellows joint adjacent the transition joint. While both references disclose a distal section which is formed to have a more flexible configuration than other parts of the guidewire, generally through the inclusion of a weakened section, these distal sections are generally flexible about an entire section and merely flex in and out of a shaped configuration, rather than articulating about a single joint.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA ROBERTS whose telephone number is (571)272-7912. The examiner can normally be reached M-F 8:30-4:30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571) 272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANNA ROBERTS/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
Prosecution Insights