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 .
Claims 1-20 are the currently pending claims. Claim 7 has been withdrawn; and claims 1-6 and 8-20 are hereby under examination.
Election/Restrictions
Claim 7 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/5/2025.
Claim Objections
Claims 1, 8, 12-15, and 18-19 are objected to because of the following informalities:
In claim 1, line 5: “a dimension of a first guidewire” is inconsistent with the remainder of the claim, which refers to the recited diameter of the guidewire and no other dimension;
Claim 1, line 7: “a dimension of a second guidewire” is inconsistent with the remainder of the claim, which refers to the recited diameter of the guidewire and no other dimension; and
A similar issue reciting “a dimension of the guidewire” is noted in claim 8 (line 3), claim 12 (line 8 and line 10), claim 13 (line 4), claim 14 (line 4), claim 15 (lines 5 and line 6), claim 18 (line 4), and claim 19 (line 4).
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 12-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth the subject matter which the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the applicant regards as the invention.
Claim 12 recites “a guidewire having one of a first diameter or a second diameter” in line 3, and further recites, in lines 3-5, that "the first portion of the channel has a first width sized to conform to a dimension of the guidewire having the first diameter, wherein the second portion of the channel has a second width sized to conform to a dimension of the guidewire having the second diameter". It is unclear whether the system requires a single guidewire that selectively has either diameter, whether different guidewires are alternately used, or whether both diameters are contemplated in a single guidewire, rendering the claim indefinite. The Examiner is interpreting the system to include a guidewire that is either the first diameter or the second diameter, and a medical component having two channel portions sized for the respective diameters.
Claims 13-14 are rejected by virtue of their dependence from claim 12.
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 1-6 and 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer (US-1389486-A), hereto referred as Brewer, and further in view of Hite (US-3230628-A), hereto referred as Hite.
Regarding claim 1, Brewer teaches a measuring instrument having a body with a channel/slot formed therein, the channel/slot having adjacent portions of progressively different widths that allow a wire or similar article to be inserted from an open end and advanced until further advancement is prevented by a width corresponding to the diameter of the article, thereby determining the gauge of the article: a body portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the numeral i indicates a body, having a slot 2 that opens out of one end of said body”, Brewer teaches a body that forms the base structure of the instrument); and a channel formed in the body portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the numeral i indicates a body, having a slot 2 that opens out of one end of said body”, Brewer’s slot is a channel formed in the body); the channel including a first portion adjacent a second portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form various widths”, Brewer teaches adjacent step-formed portions along the slot that define successive widths depicting various portions defined by the widths); the first portion including an opening of the channel (Brewer, FIG. 1-5; p. 2, ll. 57-76: “a slot 2 that opens out of one end of said body”, Brewer teaches the slot has an opening at one end); wherein the first portion of the channel has a first width sized to conform to a dimension of a first guidewire having a first diameter (Brewer, FIG. 1-5; p. 2, ll. 12-26: "the gauge of a device or article, which may be wire, drills, sheet materials, and the like can be easily and quickly determined", showing the measurement of a wire or the like; p. 2, ll. 57-76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gauges or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches a first width region at the open end that permits insertion and tight fitting of an article of a corresponding size, which corresponds to a channel width sized to conform to a wire diameter); wherein the second portion of the channel has a second width sized to conform to a dimension of a second guidewire having a second diameter (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form various widths”, Brewer teaches additional adjacent portions of the slot defining different widths to fit different gauges, corresponding to a second width sized to conform to a second wire diameter); and wherein the first diameter is greater than the second diameter (Brewer, FIG. 1-5; p. 2: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches a larger width at one end transitioning to smaller widths along the slot, corresponding to a larger first diameter than a second diameter).
Also regarding claim 1, Brewer does not expressly teach that the device is a medical component used in a surgical procedure used to measure a medical guidewire. Rather, Brewer discloses a gauge or measuring instrument having a body with a channel/slot formed therein, the channel having adjacent portions of progressively different widths such that an article (e.g., wire) is inserted from an open end and advanced until it fits tightly at a width corresponding to the diameter of the article, thereby determining the gauge/width of the article. However, Brewer does not expressly teach that the wire being measured is a guidewire used in a medical context and is measured with a medical component.
Hite teaches that surgical tool sets include instruments configured to measure the diameter of K-wires (i.e., guidewires per the Instant Application, [0002]) as part of orthopedic surgical aids, stating that the gauge determines the dimensions of “Kirchner wires” used in orthopedic surgery (Hite, col. 1, ll. 8-60; col. 2, ll. 33-50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer in view of Hite to apply Brewer’s stepped gauge channel structure to measure the diameter of a surgical guidewire (e.g., a Kirschner-wire/K-wire) used during surgical procedures. The combination would have been feasible because Brewer already teaches a simple mechanical stepped-width channel that determines the diameter of a wire by insertion until snug fit, and Hite teaches that K-wires are used by surgeons and that it is desirable to have surgical aids for measuring K-wire diameters. Further, modifying Brewer into a surgical instrument would have been feasible because the claimed structure is a simple machined or formed body defining a channel/slot, and medical instruments commonly employ rigid, sterilizable materials and finishes suitable for surgical environments, such that a stepped-width channel gauge could be manufactured in a surgical-grade material and sterilized for operating room use. The benefit of this combination would be to provide a simple, reliable, and readily manufacturable surgical guidewire/K-wire diameter sizer using known stepped-slot gauge technology, thereby facilitating correct wire selection and compatibility with other surgical tools and components.
Regarding claim 2, the modified Brewer teaches a measuring instrument but does not expressly teach that the medical component is a medical instrument used to perform a task in a surgical procedure. The modified Brewer teaches a gauge or measuring component for determining the size of guidewire and other articles, but does not expressly teach use of such a gauge as a medical instrument used during a surgical procedure.
Hite teaches a surgical aid specifically configured for use by surgeons to measure the dimensions of orthopedic screws and Kirchner wires in the operating room, stating that the invention relates to “surgical aids” for determining such dimensions (Hite, col. 1, ll. 8-60; col. 2, ll. 33-50: " This reduces chances for error and saves time in the operating room"). Hite therefore establishes that measuring the diameter of Kirschner wires, which are guidewires per the Instant Application [0002], is a task performed using medical instruments in surgical procedures.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Brewer in view of Hite to implement the wire gauge instrument as a medical instrument used to perform a task in a surgical procedure, namely measuring the diameter of a surgical guidewire. The combination would have been feasible because Hite teaches forming wire-measuring gauges as surgical instruments suitable for operating room use, and Brewer teaches a straightforward mechanical gauge structure for determining wire size that can be readily implemented in such a surgical instrument. The benefit of this combination would have been to provide surgeons with a simple, reliable medical instrument for determining guidewire diameter during a surgical procedure, thereby improving surgical efficiency and supporting appropriate instrument selection to reduce errors (Hite, col. 2, ll. 33-50).
Regarding claim 3, the modified Brewer does not teach that the medical component is one of a screw sizer, a handle of a driver, a targeting guide, a drill guide, a cannula, a handle of a cannula, a wire guide, a clamp, a retractor, a sterilization tray, or a screw caddy. Rather, the modified Brewer teaches a gauge or measuring instrument having a body portion and a channel/slot with adjacent portions that form different widths for determining the gauge of an article such as wire, and does not teach that the medical component is specifically one of a screw sizer, a handle of a driver, a targeting guide, a drill guide, a cannula, a handle of a cannula, a wire guide, a clamp, a retractor, a sterilization tray, or a screw caddy.
Hite teaches a surgical aid used in orthopedic surgery that determines the dimensions of orthopedic screws (i.e., a screw sizer) as well as k-wires (Hite, col. 1, ll. 8-15 : “This invention relates to scales and gauges and more particularly, to surgical aids which accurately and readily determine the dimensions of orthopedic screws, Kirchner wires and Steinmann pins”; col.1, ll. 38-61: "the gauge is in the form of a stainless steel scale having calibrations in millimeters and inches along the edges of one face and having a gauge for measuring the length of orthopedic screws and the diameter of wires and pins calibrated on the other face", see also FIG. 1-3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Brewer in view of Hite to configure the guidewire sizing medical component as a screw sizer used in the surgical procedure, as recited. The combination would have been feasible because Hite teaches forming a surgical screw-measuring gauge as a unitary stainless-steel instrument for operating room use, including easy sanitation (Hite, col. 1, ll. col.1, ll. 38-61: “the gauge is in the form of a stainless steel scale… Stainless steel is used to provide easy sanitation and because it holds its dimensions well under normal temperature ranges”), and Brewer’s stepped-width channel structure can be formed into (or alongside) such a screw sizer body portion using routine machining/formation techniques. The benefit of this combination would have been to reduce the number of separate instruments required during the surgical procedure by integrating the guidewire sizing feature into a screw-sizing instrument already used during the procedure, thereby improving surgical workflow and efficiency.
Regarding claim 4, the modified Brewer teaches that the first width is equal to the first diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer explains that the slot width at the wedged location corresponds to the size of the inserted cylindrical article, which is its diameter; p. 2, ll. 84-97: “moving said article along the slot until it fits snugly between a shoulder 4 and the wall 3 of said slot”, Brewer shows the article fitting snugly between opposing faces, which corresponds to the separation equaling the article’s diameter).
Regarding claim 5, the modified Brewer teaches that the second width is equal to the second diameter (Brewer, p. 2, ll. 57–76: : “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer explains that the progressively smaller widths correspond to different wire sizes such that a smaller diameter wire advances farther to a narrower portion where it fits tightly, corresponding to the second width matching the second diameter; p. 2, ll. 84-97: “moving said article along the slot until it fits snugly between a shoulder 4 and the wall 3 of said slot”, Brewer shows the article fitting snugly at a selected shoulder location corresponding to one of the narrower width portions, which corresponds to the separation equaling the article’s diameter at that portion).
Regarding claim 6, Brewer teaches that (Brewer, FIG.1-5; p. 2, ll. 57–76: “the numeral i indicates a body, having a slot 2 that opens out of one end of said body and extends to a point adjacent the other end thereof”, Brewer teaches a channel that is formed by removal of material from the body and that opens to the exterior surface; p. 2, ll. 57–76: “so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer shows that the channel receives the article between opposing walls while remaining open, such that a portion of the article circumference remains exposed relative to the exterior surface).
Alternative Construction: If “indentation” is construed to require a channel open only on one exterior side of the body portion and not extending fully through the body, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Brewer to form the channel as a surface indentation rather than as a through-slot.
Brewer teaches the functional measuring relationship in which opposing channel surfaces define a width and the article is advanced until it fits between those surfaces to determine size (Brewer, p. 2, ll. 60–66: “until wedged or fitted tightly between the walls thereof”).
Hite teaches that gauging elongate articles may be performed using an indented channel formed on an exterior surface of a rigid body, rather than a through-cut slot (Hite, claim 1: “an elongated plate having an indented channel formed longitudinally therein”; col. 2, ll. 1-11: “Downwardly in this plate is formed an indented channel 12 extending longitudinally along the center of the plate”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Brewer in view of Hite to implement Brewer’s stepped gauging geometry as a surface indentation on an exterior of the body portion. Such a modification would have been feasible because the measuring function depends on opposing surfaces defining a width and does not depend on the channel extending fully through the body. The benefit of this modification would have been to preserve the same gauging function while improving accessibility, visibility of the article during measurement, and structural integrity of the body portion.
Regarding claim 8, Brewer teaches that the channel further includes a third portion adjacent the second portion (Brewer, FIG. 1-5; p. 2, ll. 57–76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form Various widths with said slot”, Brewer teaches a plurality of adjacent step-formed shoulders that define successive portions of different widths along the slot); the third portion of the channel having a third width sized to conform to a dimension of a third guidewire having a third diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches that the slot includes progressively smaller width portions that tightly fit different size cylindrical articles, corresponding to a third width portion that conforms to a third diameter); and wherein the second diameter is greater than the third diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches that successive portions along the slot have smaller widths, corresponding to a larger diameter at an upstream portion and a smaller diameter at a further portion; see FIG. 1-5).
Regarding claim 9, the modified Brewer teaches that the third width is equal to the third diameter (Brewer, p. 2, ll. 57–76: : “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer explains that the progressively smaller widths correspond to different wire sizes such that a smaller diameter wire advances farther to a narrower portion where it fits tightly, corresponding to the third width matching the third diameter; p. 2, ll. 84-97: “moving said article along the slot until it fits snugly between a shoulder 4 and the wall 3 of said slot”, Brewer shows the article fitting snugly at a selected shoulder location corresponding to one of the narrower width portions, which corresponds to the separation equaling the article’s diameter at that portion).
Regarding claim 10, the modified Brewer teaches that the channel further includes a fourth portion adjacent the third portion (Brewer, FIG. 1-5; p. 2, ll. 57–76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form Various widths with said slot”, Brewer teaches a plurality of adjacent step-formed shoulders that define successive portions of different widths along the slot); the third portion of the channel having a third width sized to conform to a dimension of a third guidewire having a third diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches that the slot includes progressively smaller width portions that tightly fit different size cylindrical articles, corresponding to a third width portion that conforms to a third diameter); and wherein the third diameter is greater than the fourth diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches that successive portions along the slot have smaller widths, corresponding to a larger diameter at an upstream portion and a smaller diameter at a further portion; see FIG. 1-5).
Regarding claim 11, the modified Brewer teaches that the first portion of the channel includes a corner that extends a length of the first portion of the channel (Brewer, FIG. 1-5, p. 2-3, ll. 98-117: “the body 9 has one side wall cut in step formation which defines shoulders 10, the corners 11 of which are rounded”, Brewer teaches that the channel portion includes corners 11 associated with shoulders 10 and the figures depicts the corners 11 extending along the step-formed channel portion; p. 2-3, ll. 98-117: “and said shoulders extend from one end of the body 9 to a point adjacent the other end”, Brewer teaches that the shoulders 10 extend along a length of the body, such that the associated corners extend along a length of the corresponding channel portion as depicted in the figures).
Regarding claim 12, Brewer teaches that a system for obtaining a measurement of a guidewire, comprises a body portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the numeral i indicates a body, having a slot 2 that opens out of one end of said body”, Brewer teaches a body that forms the base structure of the instrument, which measures wires) and a channel formed in the body portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the numeral i indicates a body, having a slot 2 that opens out of one end of said body”, Brewer’s slot is a channel formed in the body); the channel including a first portion adjacent a second portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form various widths”, Brewer teaches adjacent step-formed portions along the slot that define successive widths depicting various portions defined by the widths); the first portion including an opening of the channel (Brewer, FIG. 1-5; p. 2, ll. 57-76: “a slot 2 that opens out of one end of said body”, Brewer teaches the slot has an opening at one end); wherein the first portion of the channel has a first width sized to conform to a dimension of the guidewire having the first diameter (Brewer, FIG. 1-5; p. 2, ll. 12-26: "the gauge of a device or article, which may be wire, drills, sheet materials, and the like can be easily and quickly determined", showing the measurement of a wire or the like; p. 2, ll. 57-76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gauges or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches a first width region at the open end that permits insertion and tight fitting of an article of a corresponding size, which corresponds to a channel width sized to conform to a wire diameter); wherein the second portion of the channel has a second width sized to conform to a dimension of the guidewire having the second diameter (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form various widths”, Brewer teaches additional adjacent portions of the slot defining different widths to fit different gauges, corresponding to a second width sized to conform to a second wire diameter); and wherein the first diameter is greater than the second diameter (Brewer, FIG. 1-5; p. 2: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches a larger width at one end transitioning to smaller widths along the slot, corresponding to a larger first diameter than a second diameter).
Also regarding claim 12, Brewer does not teach that the system is a medical component comprising a [medical] guidewire having one of a first diameter or a second diameter. Rather, Brewer discloses a gauge or measuring instrument having a body with a channel/slot formed therein, the channel having adjacent portions of progressively different widths such that an article (e.g., wire) is inserted from an open end and advanced until it fits tightly at a width corresponding to the diameter of the article, thereby determining the gauge/width of the article. However, Brewer does not expressly teach that system is a medical component and the wire being measured is a guidewire.
Hite teaches that surgical tool sets include instruments configured to measure the dimensions of Kirschner wires, which are guidewires per the Instant Application [0002], as part of orthopedic surgical aids, stating that such gauges “accurately and readily determine the dimensions of orthopedic screws, Kirchner wires and Steinmann pins” used in orthopedic surgery (Hite, col. 1, ll. 8-60). By teaching gauges calibrated to determine the dimensions of Kirschner wires, Hite indicates that such guidewires exist in multiple different diameters and that measuring components are used to determine which diameter a particular guidewire has, corresponding to a guidewire having one of a first diameter or a second diameter, even though Hite does not recite those exact words (Hite, col. 1, ll. 8–60; col. 2, ll. 33–50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer in view of Hite to apply Brewer’s stepped gauge channel structure to measure the diameter of a guidewire that may have one of several different diameters. The combination would have been feasible because Brewer already teaches a simple mechanical stepped-width channel that determines the diameter of a wire by insertion until snug fit, and Hite teaches that K-wires are used by surgeons and that it is desirable to have surgical aids for measuring K-wire diameters. Further, modifying Brewer into a surgical instrument would have been feasible because the claimed structure is a simple machined or formed body defining a channel/slot, and medical instruments commonly employ rigid, sterilizable materials and finishes suitable for surgical environments, such that a stepped-width channel gauge could be manufactured in a surgical-grade material and sterilized for operating room use. The benefit of this combination would be to provide a simple, reliable, and readily manufacturable guidewire/K-wire diameter sizer using known stepped-slot gauge technology, thereby facilitating correct wire selection and compatibility with other surgical tools and components.
Regarding claim 13, the modified Brewer teaches that the guidewire has one of the first diameter, the second diameter, or a third diameter (As established in Claim 12 above, the modified Brewer is applied to measure the diameter of a guidewire that may have one of several different diameters, which includes a third diameter); wherein the channel of the medical component further includes a third portion adjacent the second portion (Brewer, FIG. 1-5; p. 2, ll. 57–76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form Various widths with said slot”, Brewer teaches a plurality of adjacent step-formed shoulders that define successive portions of different widths along the slot); the third portion of the channel having a third width sized to conform to a dimension of the guidewire having the third diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches that the slot includes progressively smaller width portions that tightly fit different size cylindrical articles, corresponding to a third width portion that conforms to a third diameter); and wherein the second diameter is greater than the third diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches that successive portions along the slot have smaller widths, corresponding to a larger diameter at an upstream portion and a smaller diameter at a further portion; see FIG. 1-5).
Regarding claim 14, the modified Brewer teaches that the guidewire has one of the first diameter, the second diameter, the third diameter, or a fourth diameter (As established in Claim 12 above, the modified Brewer is applied to measure the diameter of a guidewire that may have one of several different diameters, which includes a third or fourth diameter); wherein the channel further includes a fourth portion adjacent the third portion (Brewer, FIG. 1-5; p. 2, ll. 57–76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form Various widths with said slot”, Brewer teaches a plurality of adjacent step-formed shoulders that define successive portions of different widths along the slot, including a further portion adjacent the prior portion); the fourth portion of the channel having a fourth width sized to conform to a dimension of the guidewire having the fourth diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches that the slot includes progressively smaller width portions that tightly fit different size cylindrical articles, corresponding to a fourth width portion that conforms to a fourth diameter); and wherein the third diameter is greater than the fourth diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches that successive portions along the slot have smaller widths, corresponding to a larger diameter at an upstream portion and a smaller diameter at a further portion; see FIG. 1-5).
Regarding claim 15, Brewer teaches a method for obtaining a measurement of a guidewire having one of a first diameter or a second diameter... including a body portion (Brewer, FIG. 1-5; p. 2, ll. 1-20: "This invention relates to new and useful improvements in gages or measuring instruments and has for its primary object the provision of means, whereby the gage of a device or article, which may be wire, drills, sheet materials, and the like can be easily and quickly determined or obtained"; p. 2, ll. 57-76: “the numeral i indicates a body, having a slot 2 that opens out of one end of said body”, Brewer teaches a body portion) and a channel formed in the body portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the numeral i indicates a body, having a slot 2 that opens out of one end of said body”, Brewer teaches a channel/slot formed in the body portion); the channel including a first portion adjacent a second portion (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form various widths”, Brewer teaches adjacent portions along the slot that define successive widths); the first portion including an opening of the channel (Brewer, FIG. 1-5; p. 2, ll. 57-76: “a slot 2 that opens out of one end of said body”, Brewer teaches an opening of the channel); wherein the first portion of the channel is sized to conform to a dimension of the guidewire having the first diameter (Brewer, FIG. 1-5; p. 2, ll. 12-26: "the gauge of a device or article, which may be wire, drills, sheet materials, and the like can be easily and quickly determined", showing the measurement of a wire or the like; p. 2, ll. 12-26: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gauges or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches a first width region at the open end that permits insertion and tight fitting of an article of a corresponding size, which corresponds to a channel width sized to conform to a wire diameter); wherein the second portion of the channel is sized to conform to a dimension of the guidewire having the second diameter (Brewer, FIG. 1-5; p. 2, ll. 57-76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form various widths”, Brewer teaches additional portions of the slot defining different widths to fit different wire sizes); and wherein the first diameter is greater than the second diameter (Brewer, p. 2, ll. 57-76: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches decreasing widths along the slot corresponding to larger to smaller diameters); the method comprising: inserting a tip of the guidewire into the channel through the opening (Brewer, p. 2, ll. ll. 57-76: “articles of different gauges or sizes can be inserted in said slot from its open end”, Brewer teaches inserting an article into the channel through the opening); until advancement of the tip of the guidewire further into the channel is prevented (Brewer, p. 2, ll. 57-76: “passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches advancing the article until it wedges or fits tightly, which prevents further advancement).
Also regarding claim 15, Brewer does not expressly teach that method uses a medical component to obtain the measurement of the [medical] guidewire. Rather, Brewer discloses a gauge or measuring instrument having a body with a channel/slot formed therein, the channel having adjacent portions of progressively different widths such that an article (e.g., wire) is inserted from an open end and advanced along the slot until it is “wedged or fitted tightly between the walls” to thereby determine or obtain the gauge of the article. However, Brewer does not expressly teach that measurement device is a medical component or that the guidewire is medical in nature.
Hite teaches that surgical tool sets include instruments configured to measure the dimensions of Kirschner wires, which are guidewires per the Instant Application [0002], as part of orthopedic surgical aids, stating that such gauges “accurately and readily determine the dimensions of orthopedic screws, Kirchner wires and Steinmann pins” used in orthopedic surgery (Hite, col. 1, ll. 8-60). By teaching gauges calibrated to determine the dimensions of Kirschner wires, Hite indicates that such guidewires exist in multiple different diameters and that measuring components are used to determine which diameter a particular guidewire has, corresponding to a guidewire having one of a first diameter or a second diameter, even though Hite does not recite those exact words (Hite, col. 1, ll. 8–60; col. 2, ll. 33–50).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brewer in view of Hite to apply Brewer’s stepped gauge channel structure to measure the diameter of a guidewire that may have one of several different diameters. The combination would have been feasible because Brewer already teaches a method in which a wire is inserted into a stepped-width channel and advanced along the channel until the wire wedges or fits tightly between opposing surfaces, thereby preventing further advancement and enabling determination of the wire gauge. Hite teaches that surgeons use medical components, specifically surgical aids, to measure the dimensions of Kirschner wires in orthopedic procedures. Applying Brewer’s stepped-width channel structure in a surgical measurement method would therefore have been a straightforward and predictable adaptation, as the claimed steps rely on manual insertion and advancement of the guidewire within a simple machined or formed channel, and medical instruments are routinely manufactured from rigid, sterilizable materials suitable for surgical environments, as evidenced by Hite. The benefit of this combination would be to provide a simple, reliable, and readily performable method for determining the diameter of a surgical guidewire or K-wire using known stepped-slot gauging technology, thereby facilitating correct guidewire selection and compatibility with other surgical tools and components.
Regarding claim 16, the modified Brewer teaches that the method further comprises: advancing the tip of the guidewire further into the channel (Brewer, p. 2, ll. 57-76: “articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches passing/advancing the inserted article along the slot); until advancement of the tip of the guidewire further into the channel is prevented at an endpoint of the second portion of the channel (Brewer, p. 2, ll. 84-97: “moving said article along the slot until it fits snugly between a shoulder 4 and the wall 3 of said slot”, Brewer teaches advancement being prevented when the article fits snugly at a shoulder defining one of the step-formed portions of the slot); and obtaining the measurement of the guidewire as the second diameter (Brewer, p. 2, ll. 77-83: “when an article is properly fitted between a certain shoulder and the wall 3 of said slot, the respective character to said shoulder indicates the gage of said article”, Brewer teaches obtaining the measurement by identifying the gage/size corresponding to the shoulder at which the article is prevented from further advancement).
Regarding claim 17, the modified Brewer teaches that the method further comprises: advancing the tip of the guidewire further into the channel (Brewer, p. 2, ll. 57-76: “articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches passing/advancing the inserted article along the slot); until advancement of the tip of the guidewire further into the channel is prevented at an endpoint of the first portion of the channel (Brewer, p. 2, ll. 84-97: “moving said article along the slot until it fits Snugly between a shoulder 4 and the wall 3 of said slot”, Brewer teaches advancement being prevented when the article fits snugly at a shoulder defining one of the step-formed portions of the slot); and obtaining the measurement of the guidewire as the first diameter (Brewer, p. 2, ll. 77-83: “when an article is properly fitted between a certain shoulder and the wall 3 of said slot, the respective character to said shoulder indicates the gage of said article”, Brewer teaches obtaining the measurement by identifying the gage/size corresponding to the shoulder at which the article is prevented from further advancement).
Regarding claim 18, the modified Brewer teaches that the guidewire has one of the first diameter, the second diameter, or a third diameter (As established in Claim 15 above, the modified Brewer is applied to obtain a measurement of a guidewire that may have one of several different diameters, which includes a third diameter); wherein the channel of the medical component further includes a third portion adjacent the second portion (Brewer, FIG. 1-5; p. 2, ll. 57–76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form Various widths with said slot”, Brewer teaches a plurality of adjacent step-formed shoulders that define successive portions of different widths along the slot); the third portion of the channel sized to conform to a dimension of the guidewire having the third diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches that the slot includes progressively smaller width portions that tightly fit different size cylindrical articles, corresponding to a third width portion that conforms to a third diameter); and wherein the second diameter is greater than the third diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches that successive portions along the slot have smaller widths, corresponding to a larger diameter at an upstream portion and a smaller diameter at a further portion; see FIG. 1-5).
Regarding claim 19, the modified Brewer teaches that wherein the guidewire has one of the first diameter, the second diameter, the third diameter, or a fourth diameter (As established in Claim 15 above, the modified Brewer is applied to obtain a measurement of a guidewire that may have one of several different diameters, which includes a fourth diameter); wherein the channel further includes a fourth portion adjacent the third portion (Brewer, FIG. 1-5; p. 2, ll. 57–76: “the other wall has a plurality of projections or shoulders 4 arranged in step formation so as to form Various widths with said slot”, Brewer teaches a plurality of adjacent step-formed shoulders that define successive portions of different widths along the slot, including a further portion adjacent the prior portion); the fourth portion of the channel sized to conform to a dimension of the guidewire having the fourth diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end, so that articles of different gages or sizes can be inserted in said slot from its open end and passed along the same until wedged or fitted tightly between the walls thereof”, Brewer teaches that the slot includes progressively smaller width portions that tightly fit different size cylindrical articles, corresponding to a fourth width portion that conforms to a fourth diameter); and wherein the third diameter is greater than the fourth diameter (Brewer, p. 2, ll. 57–76: “The slot decreases in width progressively from one end in the direction of the other end”, Brewer teaches that successive portions along the slot have smaller widths, corresponding to a larger diameter at an upstream portion and a smaller diameter at a further portion; see FIG. 1-5).
Regarding claim 20, the modified Brewer does not teach that the method further comprises performing a surgical procedural task using the medical component, the surgical procedural task being separate from obtaining the measurement of the guidewire. Rather, as established in Claim 15 above, the modified Brewer is applied to a method for obtaining a measurement of a guidewire by a medical component. However, the modified Brewer does not expressly teach performing an additional surgical procedural task using the same medical component that is separate from obtaining the measurement of the guidewire.
Hite teaches a single unitary surgical aid used in orthopedic surgery that performs multiple surgical measurement tasks, including measuring orthopedic screws using an indented channel and a head-receiving aperture that form a matrix so the screw “may be inserted readily to provide an unquestionable gauge of length”, and also measuring wire diameters using circular aperture gauges calibrated to Kirchner wires (Hite, col. 2, ll. 3-22: “an indented channel 12 extending longitudinally along the center of the plate”, “the aperture 16 and channel 12 form a matrix in which the screw 15 may be inserted readily to provide an unquestionable gauge of length”; Hite, col. 2, ll. 12-33: “a series of spaced circular aperture gauges 25 …matching standard sizes of Kirchner wires or Steinmann pins used in orthopedic surgery”; Hite, col. 2, ll. 33-50: “This reduces chances for error and saves time in the operating room”); where the Instant Application gives an example of a separate surgical procedural task as: “(e.g., determine a screw size for installation)” (Instant Application, [0040]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the modified Brewer in view of Hite to further perform a surgical procedural task using the medical component that is separate from obtaining the measurement of the guidewire, by configuring the same medical component to also be used to measure an orthopedic screw during the surgical procedure. The combination would have been feasible because Hite teaches a unitary surgical gauge that includes both a wire diameter gauging function and an orthopedic screw measuring function in a single stainless steel plate instrument, and the modified Brewer teaches a straightforward mechanical stepped-width channel for determining wire diameter by insertion until snug fit, such that the modified Brewer stepped-width guidewire measurement feature could be incorporated into, or formed alongside, the screw-measuring matrix features taught by Hite using routine machining and formation techniques. The benefit of this combination would have been to reduce the number of separate instruments required during the surgical procedure by integrating guidewire diameter measurement and screw measurement into a single medical component, thereby reducing chances for error and saving time in the operating room as taught by Hite (Hite, col. 2, ll. 12-50).
Conclusion
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791