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 .
Applicant' s arguments, filed 7/23/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 7/23/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-21 are the currently pending claims. Claim 7 has been previously withdrawn. Claims 1-6, 8-15, and 18-20 have been amended. Claim 21 has been added. Claims 1-6 and 8-21 are hereby under examination.
Claim Objections
Claims 2 and 20 are objected to because of the following informalities:
In claim 2, lines 1-2: “the surgical procedure task” is inconsistent with the antecedent “a surgical procedural task” in claim 1 and should be revised to “the surgical procedural task”; and
In claim 20, line 4: “the surgical procedural task is a task that needs the measurement of the guidewire be obtained” is grammatically incorrect and should be revised to “wherein the surgical procedural task is a task that requires the measurement of the guidewire to be obtained”.
Appropriate correction is required.
Claim Interpretation
Regarding claims 1, 12, and 15, the limitation of a “surgical procedural task separate from being a sizer” is interpreted as requiring a surgical procedural task separate from the guidewire-sizing function of the previously recited “integrated guidewire sizer”. The limitation does not exclude a separate task merely because that task involves determining a dimension or size of a different surgical component using a different method. This interpretation is consistent with the context of the claim language and with the Specification. Specifically, paragraph [0040] states that, after measuring the guidewire, the surgeon may “subsequently perform a separate surgical procedural task (e.g., determine a screw size for installation) using medical instrument 200.” This interpretation is also consistent with dependent claim 3, which identifies a screw sizer as one of the recited medical instruments. A construction that excluded every additional sizing function would exclude both the Specification's express example and the screw-sizer species recited in claim 3, and therefore would not be the broadest reasonable interpretation consistent with the Specification. Accordingly, the phrase “separate from being a sizer” distinguishes the recited surgical procedural task from the guidewire-sizing function of the integrated guidewire sizer and does not require that the second task be wholly unrelated to sizing another component.
Regarding claim 2, the limitation “wherein the surgical procedure task is a task in which the guidewire needs to be sized” is interpreted as requiring the recited surgical procedural task to be performed in a surgical procedure in which guidewire sizing is needed. The limitation does not require that the result of the guidewire sizing be used as an input to, or otherwise control, performance of the separate surgical procedural task. This interpretation is consistent with the Specification, which explains that the medical instrument may be any suitable instrument used “during a procedure in which a guidewire's diameter may need to be measured” and expressly identifies screw sizers among the examples. See Spec. ¶[0031].
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 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer (U.S. Patent No. 1,389,486), hereinafter Brewer, and further in view of Hite (U.S. Patent No. 3,230,628), hereinafter 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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 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, FIGS. 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 first diameter of a first guidewire (Brewer, FIGS. 1-5; p. 2, ll. 12-18: “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”, 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 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 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 second diameter of a second guidewire (Brewer, FIGS. 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, FIGS. 1-5; p. 2, ll. 57-76: “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 a medical instrument comprising an integrated guidewire sizer 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, such as a 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 or 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 instrument.
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 modified Brewer in view of Hite to implement Brewer's wire gauge 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 resulting medical instrument includes Brewer's stepped-width channel as an integrated guidewire sizer configured to determine the diameter of a surgical guidewire. 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).
Also, regarding claim 1, the modified Brewer does not teach wherein the medical instrument is further configured to be used to perform a surgical procedural task separate from being a sizer. Rather, as established above, the modified Brewer is configured as a medical instrument for determining the diameter of a surgical guidewire. However, the modified Brewer does not teach that the same medical instrument is further configured to perform a surgical procedural task separate from the guidewire-sizing function.
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 to provide a gauge of screw length, and also measuring wire diameters using circular aperture gauges calibrated to Kirchner wires (Hite, col. 2, ll. 3-22; col. 2, ll. 33-50). Hite further teaches that the screw gauges and wire gauges provide the surgeon with a single versatile scale-gauge so that several separate instruments are unnecessary, thereby reducing chances for error and saving time in the operating room (Hite, col. 2, ll. 33-50). Under the claim interpretation set forth above, Hite's orthopedic screw-measuring function is a surgical procedural task separate from the guidewire-sizing function.
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 instrument that is separate from the guidewire-sizing function, by configuring the same medical instrument 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. 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 instrument, thereby reducing chances for error and saving time in the operating room as taught by Hite (Hite, col. 2, ll. 33-50).
Regarding claim 2, the modified Brewer does not fully teach wherein the surgical procedure task is a task in which the guidewire needs to be sized. Rather, as established regarding claim 1, the modified Brewer includes an integrated guidewire sizer and is further configured to perform the separate surgical procedural task of determining the size of an orthopedic screw. However, the modified Brewer does not expressly teach that the orthopedic screw-sizing task is performed in a surgical procedure in which guidewire sizing is needed.
Hite teaches that, during orthopedic operating-room procedures, selection of an incorrect screw length or a wire or pin having an unsuitable diameter may cause serious consequences, and therefore provides a unitary surgical gauge for accurately determining both orthopedic screw dimensions and the diameters of Kirschner wires and Steinmann pins (Hite, col. 1, ll. 8-61). Hite further teaches that the calibrated Kirschner-wire and Steinmann-pin gauges are used in combination with the screw gauges on the same surgical aid so that the surgeon need not carry several instruments for reference, thereby reducing chances for error and saving time in the operating room (Hite, 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 used the modified Brewer's screw-sizing function in the orthopedic procedures contemplated by Hite, in which both the proper orthopedic screw dimension and the proper Kirschner-wire diameter are determined. Hite expressly identifies incorrect screw length and unsuitable wire or pin diameter as measurement and selection problems encountered in orthopedic operating-room procedures and addresses both problems with one surgical aid, which contains two separate features. A person of ordinary skill therefore would have had reason to use the combined instrument during an orthopedic procedure requiring both screw sizing and guidewire sizing so that the appropriate screw and guidewire could be selected while reducing measurement and selection errors and saving operating-room time. In the resulting use, the separate surgical procedural task of determining the orthopedic screw size is a task in which the guidewire needs to be sized.
Regarding claim 3, the modified Brewer teaches wherein the medical instrument 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, or a retractor, through the screw-sizer alternative. The Hite teaching incorporated regarding claims 1 and 2 configures the same unitary surgical instrument to determine the dimensions of orthopedic screws using a screw-measuring gauge, thereby providing a screw sizer (Hite, col. 1, ll. 8-15; col. 1, ll. 38-61; FIGS. 1-3).
Regarding claim 4, the modified Brewer teaches wherein 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 wherein 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, the modified Brewer teaches wherein the channel is an indentation on an exterior of the body portion (Brewer, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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 extends inward from an open end of the body and is open to the exterior; 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. 57-76: “until wedged or fitted tightly between the walls thereof”).
Hite teaches that gauging an elongate article 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. 3-11: “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 wherein the channel further includes a third portion adjacent the second portion (Brewer, FIGS. 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 third diameter of a third guidewire (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 guidewire 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 FIGS. 1-5).
Regarding claim 9, the modified Brewer teaches wherein 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 wherein the channel further includes a fourth portion adjacent the third portion (Brewer, FIGS. 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 fourth diameter of a fourth guidewire (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 portion that conforms to a fourth guidewire 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 FIGS. 1-5).
Regarding claim 11, the modified Brewer teaches wherein the first portion of the channel includes a corner that extends a length of the first portion of the channel (Brewer, FIGS. 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; 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 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 a system for obtaining a measurement of a guidewire, comprising a body portion (Brewer, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 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, FIGS. 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 the first diameter (Brewer, FIGS. 1-5; p. 2, ll. 12-18: “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”, 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 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 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 the second diameter (Brewer, FIGS. 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, FIGS. 1-5; p. 2, ll. 57-76: “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 fully teach a guidewire having one of a first diameter or a second diameter; and a medical instrument including an integrated guidewire sizer configured to obtain the measurement of the 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, such as a 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 medical guidewire having one of the recited diameters or that the measuring instrument is a medical instrument including an integrated guidewire sizer configured to obtain the measurement of the 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 instruments are used to determine which diameter a particular guidewire has, corresponding to a guidewire having one of a first diameter or a second diameter (Hite, col. 1, ll. 8-60; col. 2, ll. 33-38).
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 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. Hite further teaches forming its surgical gauge from stainless steel to provide easy sanitation and dimensional stability (Hite, col. 1, ll. 38-61). The benefit of this combination would have been 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. The resulting medical instrument includes Brewer's stepped-width channel as an integrated guidewire sizer configured to obtain the measurement of the guidewire.
Also, regarding claim 12, the modified Brewer does not teach wherein the medical instrument is further configured to perform a surgical procedural task separate from being a sizer. Rather, as established above, the modified Brewer includes an integrated guidewire sizer configured to obtain the measurement of a surgical guidewire. However, the modified Brewer does not teach that the same medical instrument is further configured to perform a surgical procedural task separate from the guidewire-sizing function.
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; col. 2, ll. 33-38). Hite further teaches that the wire gauges and screw gauges provide the surgeon with a single versatile scale-gauge so that several separate instruments are unnecessary, thereby reducing chances for error and saving time in the operating room (Hite, col. 2, ll. 33-50). Under the claim interpretation set forth above, Hite's orthopedic screw-measuring function is a surgical procedural task separate from the guidewire-sizing function.
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 instrument that is separate from the guidewire-sizing function, by configuring the same medical instrument 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 instrument, thereby reducing chances for error and saving time in the operating room as taught by Hite (Hite, col. 2, ll. 33-50).
Regarding claim 13, the modified Brewer teaches wherein the guidewire has one of the first diameter, the second diameter, or a third diameter (as established regarding 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 instrument further includes a third portion adjacent the second portion (Brewer, FIGS. 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 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 FIGS. 1-5).
Regarding claim 14, the modified Brewer teaches wherein the guidewire has one of the first diameter, the second diameter, the third diameter, or a fourth diameter (as established regarding 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, FIGS. 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 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 FIGS. 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, FIGS. 1-5; p. 2, ll. 12-18: “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 1 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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 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, FIGS. 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 the first diameter (Brewer, FIGS. 1-5; p. 2, ll. 12-18: “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”, 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 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 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 the second diameter (Brewer, FIGS. 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); inserting a tip of the guidewire into the channel through the opening (Brewer, p. 2, ll. 57-76: “articles of different gages 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); and obtaining the measurement of the guidewire (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 gauge corresponding to the shoulder at which the article fits).
Also, regarding claim 15, Brewer does not expressly teach that the method uses a medical instrument comprising an integrated guidewire sizer 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, such as a 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 the measurement device is a medical instrument comprising an integrated guidewire sizer 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 instruments are used to determine which diameter a particular guidewire has, corresponding to a guidewire having one of a first diameter or a second diameter (Hite, col. 1, ll. 8-60; col. 2, ll. 33-38).
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 implement Brewer's stepped gauge channel structure as an integrated guidewire sizer of a medical instrument used 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 surgical aids to measure the dimensions of Kirschner wires in orthopedic procedures and further teaches forming its surgical gauge from stainless steel to provide easy sanitation and dimensional stability (Hite, col. 1, ll. 38-61). The benefit of this combination would have been 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.
Also, regarding claim 15, the modified Brewer does not teach performing a surgical procedural task using the medical instrument, the surgical procedural task being separate from being a sizer. Rather, as established above, the modified Brewer is applied to a method for obtaining a measurement of a guidewire using a medical instrument comprising an integrated guidewire sizer. However, the modified Brewer does not teach performing an additional surgical procedural task using the same medical instrument that is separate from the guidewire-sizing function.
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 Kirschner 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. 33-38: “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”). Under the claim interpretation set forth above, Hite's orthopedic screw-measuring function is a surgical procedural task separate from the guidewire-sizing function.
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 instrument that is separate from the guidewire-sizing function, by configuring the same medical instrument 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 instrument, thereby reducing chances for error and saving time in the operating room as taught by Hite (Hite, col. 2, ll. 33-50).
Regarding claim 16, the modified Brewer teaches wherein advancement of the tip of the guidewire further into the channel is prevented upon the tip of the guidewire reaching 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 wherein the measurement of the guidewire is obtained 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 gauge/size corresponding to the shoulder at which the article is prevented from further advancement).
Regarding claim 17, the modified Brewer teaches wherein advancement of the tip of the guidewire further into the channel is prevented upon the tip of the guidewire reaching 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 wherein the measurement of the guidewire is obtained 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 gauge/size corresponding to the shoulder at which the article is prevented from further advancement).
Regarding claim 18, the modified Brewer teaches wherein the guidewire has one of the first diameter, the second diameter, or a third diameter (as established regarding 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 instrument further includes a third portion adjacent the second portion (Brewer, FIGS. 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 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 FIGS. 1-5).
Regarding claim 19, the modified Brewer teaches wherein the guidewire has one of the first diameter, the second diameter, the third diameter, or a fourth diameter (as established regarding 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, FIGS. 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 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 FIGS. 1-5).
Claims 1, 12, 15 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brewer (U.S. Patent No. 1,389,486), hereinafter Brewer, and further in view of Nadeau (Kara Nadeau, “Safe and battle-ready,” Healthcare Purchasing News, Sept. 22, 2018, available at www.hpnonline.com/sterile-processing/article/13001349/safe-and-battle-ready (last accessed Aug. 19, 2026)), hereinafter Nadeau.
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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 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, FIGS. 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 first diameter of a first guidewire (Brewer, FIGS. 1-5; p. 2, ll. 12-18: “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”, 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 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 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 second diameter of a second guidewire (Brewer, FIGS. 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, FIGS. 1-5; p. 2, ll. 57-76: “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 a medical instrument comprising an integrated guidewire sizer 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, such as a 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 or 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 instrument.
Nadeau teaches a gSource gRack specifically for K-wires and pins, model gS 98.5409, that accommodates common K-wire and pin diameter sizes from 0.7 mm to 4.5 mm and includes a measuring gauge on which the K-wire and pin diameters are marked (Nadeau, pp. 6-8). Nadeau therefore teaches measuring surgical K-wires having different diameters using a device intended for K-wire use in the operating-room environment.
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 Nadeau to apply Brewer's stepped gauge channel structure to measure the diameter of surgical K-wires having different standard diameters. Brewer already teaches a simple mechanical stepped-width channel by which the diameter of a wire is easily and quickly determined by advancing the wire until it fits at the corresponding width, while Nadeau teaches the need to identify K-wires among numerous available diameter sizes and provides a measuring gauge for those K-wires. A person of ordinary skill would therefore have had reason to use Brewer's known stepped-width wire-gauge geometry for the K-wire measuring function taught by Nadeau. The structures are mechanically compatible because both perform passive dimensional measurement of wires, and Brewer's channel requires only insertion of the wire into progressively narrower gauge portions. The resulting medical instrument uses Brewer's stepped-width channel to determine the diameter of surgical K-wires, thereby providing the recited integrated guidewire sizer.
Also, regarding claim 1, the modified Brewer does not teach wherein the medical instrument is further configured to be used to perform a surgical procedural task separate from being a sizer. Rather, as established above, the modified Brewer is configured as a medical instrument for determining the diameter of a surgical K-wire. However, the modified Brewer does not teach that the same medical instrument is further configured to perform a surgical procedural task separate from the guidewire-sizing function.
Nadeau further teaches that the same gRack having the K-wire measuring gauge includes 12 slots for storage and organization of the different K-wire and pin diameter sizes, with the diameters marked on both the measuring gauge and the slots “for easy identification and organization.” Nadeau teaches that the gRack folds closed with the K-wires and pins held securely in place to prevent shifting and, when open, converts to a tabletop stand for use in the operating room (Nadeau, pp. 6-8). Thus, in addition to the measuring function, Nadeau teaches using the same K-wire device to organize, securely retain, and present K-wires for selection and use during the surgical procedure.
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 Nadeau by integrating the Brewer stepped-width K-wire measuring feature into the gRack-type instrument while retaining Nadeau's K-wire organization, secure-retention, and tabletop-stand functions. Nadeau itself provides the reason for combining these functions on the same instrument by identifying difficulties associated with organizing and storing K-wires and pins having numerous different diameter sizes and by providing both a measuring gauge and corresponding diameter-marked organizational locations for easy identification and organization. Nadeau further teaches that the same rack securely holds the K-wires and pins and presents them in a tabletop stand for selection and use in the operating room. The modification would have been mechanically compatible because Nadeau already teaches the measuring gauge and the organizational and retention structures together on the same physical rack, while Brewer merely supplies a known alternative geometry for performing the wire-measuring function. The resulting medical instrument retains the separate surgical-procedure functions of organizing, securely holding, and presenting K-wires for selection and use while using Brewer's stepped-width channel for guidewire sizing, thereby configuring the instrument to perform a surgical procedural task separate from the guidewire-sizing function. This treatment is consistent with the Specification's description of a guidewire sizer integrated with an instrument or another suitable item used to perform at least one other task during a surgical procedure. See Spec. ¶[0030].
Regarding claim 12, Brewer teaches a body portion (Brewer, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 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, FIGS. 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 the first diameter (Brewer, FIGS. 1-5; p. 2, ll. 12-18: “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”, 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 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 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 the second diameter (Brewer, FIGS. 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, FIGS. 1-5; p. 2, ll. 57-76: “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 fully teach a system for obtaining a measurement of a guidewire, the system comprising: a guidewire having one of a first diameter or a second diameter; and a medical instrument including an integrated guidewire sizer configured to obtain the measurement of the guidewire. Rather, Brewer teaches a measuring instrument for determining the gauge of an article, which may be a wire, using the stepped-width channel discussed above. However, Brewer does not expressly teach that the wire is a surgical guidewire or that the measuring instrument is a medical instrument including an integrated guidewire sizer.
Nadeau teaches that effectively organizing and storing K-wires and pins is difficult because many different lengths and diameter sizes are available. Nadeau further teaches gSource's gRack for 9-inch K-wires and pins, model gS 98.5409, which includes 12 slots for common K-wire and pin diameter sizes from 0.7 mm to 4.5 mm and a measuring gauge marked with the K-wire and pin diameters (Nadeau, pp. 6-8). Nadeau therefore teaches surgical K-wires having different available diameters together with a surgical device having a measuring gauge for those K-wires.
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 Nadeau to use Brewer's stepped-width wire-gauging structure as the measuring gauge for the surgical K-wires of Nadeau's gRack. Brewer teaches determining wire gauge by inserting a wire into a progressively narrowing stepped slot until the wire fits tightly, while Nadeau teaches that surgical K-wires are available in numerous different diameters and provides a measuring gauge for those K-wires. A person of ordinary skill would therefore have been motivated to apply Brewer's known wire-gauging structure to Nadeau's K-wire measuring function to determine which of the available K-wire diameters is present. The modification would have been technically compatible because both arrangements perform passive mechanical measurement of wire diameter and would not require alteration of the K-wires or the organizational functions of Nadeau's rack. The resulting system would include a surgical guidewire having one of the available diameters and a medical instrument including Brewer's stepped-width channel as an integrated guidewire sizer configured to obtain the measurement of the guidewire.
Also, regarding claim 12, the modified Brewer does not teach wherein the medical instrument is further configured to perform a surgical procedural task separate from being a sizer. Rather, the modified Brewer includes a medical instrument having an integrated guidewire sizer configured to obtain the measurement of a surgical K-wire, but does not teach that the same medical instrument is further configured to perform a separate surgical procedural task.
Nadeau further teaches that the same gRack having the K-wire measuring gauge includes 12 slots for storage and organization of the different K-wire and pin diameter sizes, with the K-wire and pin diameters marked on both the measuring gauge and the slots for “easy identification and organization.” Nadeau teaches that the gRack folds closed for storage, securely holds the K-wires and pins in place to prevent shifting when closed, and converts when open into a tabletop stand that presents the organized K-wires for selection and use in the operating room (Nadeau, pp. 6-8).
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 Nadeau to configure the same medical instrument to organize, securely retain, and present K-wires for selection and use during the surgical procedure in addition to performing the guidewire-sizing function. Nadeau identifies the difficulty associated with effectively organizing and storing K-wires and pins having numerous different lengths and diameter sizes and addresses that difficulty by providing the measuring gauge together with organized K-wire slots on the same rack. Nadeau further teaches that the rack securely retains the K-wires when closed and converts to a tabletop stand for use in the operating room when open. A person of ordinary skill would therefore have been motivated to retain those organization, retention, and surgical-use presentation functions when using Brewer's stepped-width wire-gauging structure as the measuring gauge of Nadeau's K-wire rack. The modification would have been technically compatible because Nadeau itself provides a K-wire measuring gauge together with the separate K-wire organization, retention, and tabletop-stand features on the same physical instrument. The resulting medical instrument would obtain the guidewire measurement using the integrated guidewire sizer and would also perform the separate surgical procedural task of organizing, securely retaining, and presenting K-wires for selection and use during the surgical procedure. See Spec. ¶[0030].
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, FIGS. 1-5; p. 2, ll. 12-18: “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 1 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, FIGS. 1-5; p. 2, ll. 57-76: “the numeral 1 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, FIGS. 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, FIGS. 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 the first diameter (Brewer, FIGS. 1-5; p. 2, ll. 12-18: “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”, 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 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 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 the second diameter (Brewer, FIGS. 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); inserting a tip of the guidewire into the channel through the opening (Brewer, p. 2, ll. 57-76: “articles of different gages 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); and obtaining the measurement of the guidewire (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 gauge corresponding to the shoulder at which the article fits).
Also, regarding claim 15, Brewer does not expressly teach that the method uses a medical instrument comprising an integrated guidewire sizer 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, such as a 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 the measurement device is a medical instrument comprising an integrated guidewire sizer or that the guidewire is medical in nature.
Nadeau teaches a gSource gRack specifically for K-wires and pins, model gS 98.5409, which accommodates common K-wire and pin diameter sizes from 0.7 mm to 4.5 mm and includes a measuring gauge on which the K-wire and pin diameters are marked. Nadeau further identifies difficulties associated with effectively organizing and storing K-wires and pins because numerous lengths and diameter sizes are available (Nadeau, pp. 6-8).
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 Nadeau to apply Brewer's stepped gauge channel and associated measurement method to obtain the diameter of surgical K-wires having different available diameters. Brewer already teaches a method in which a wire is inserted into a stepped-width channel and advanced until the wire wedges or fits tightly between opposing surfaces, thereby preventing further advancement and enabling determination of the wire gauge. Nadeau teaches that surgical K-wires are provided in numerous different diameters and provides a measuring gauge for those K-wires. A person of ordinary skill would therefore have had reason to apply Brewer's known stepped-width wire-gauging method to the K-wire measuring function taught by Nadeau. The operations are compatible because both concern passive dimensional measurement of wires, and Brewer's method requires only insertion and advancement of the wire through progressively narrower gauge portions until fit. The resulting method obtains the measurement of a surgical guidewire using Brewer's stepped-width channel as the integrated guidewire sizer of the medical instrument.
Also, regarding claim 15, the modified Brewer does not teach performing a surgical procedural task using the medical instrument, the surgical procedural task being separate from being a sizer. Rather, as established above, the modified Brewer is applied to obtain a measurement of a surgical guidewire using a medical instrument comprising an integrated guidewire sizer. However, the modified Brewer does not teach using the same medical instrument to perform a surgical procedural task separate from the guidewire-sizing function.
Nadeau further teaches that the same gRack having the K-wire measuring gauge includes 12 slots for storage and organization of the different K-wire and pin diameter sizes, with the K-wire and pin diameters marked on both the measuring gauge and the slots “for easy identification and organization.” Nadeau teaches that the gRack holds the K-wires and pins securely in place when closed and, when open, converts to a tabletop stand that presents the organized K-wires for selection and use in the operating room (Nadeau, pp. 6-8).
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 Nadeau to use the same medical instrument to identify, organize, and present K-wires for selection and use during the surgical procedure. Nadeau identifies difficulties associated with managing K-wires and pins having numerous different diameter sizes and addresses those difficulties by providing a measuring gauge together with diameter-marked organizational locations for easy identification and organization. Nadeau further teaches configuring the same device as a tabletop stand for use in the operating room, where the organized K-wires remain available for selection and surgical use. The modification would have been mechanically compatible because Nadeau already provides the measuring gauge, organizational slots, and tabletop-stand structure on the same physical rack, while Brewer supplies a known alternative geometry and method for performing the wire-sizing function. The resulting method uses the medical instrument both to obtain the guidewire measurement using Brewer's stepped-width channel and to identify, organize, and present that guidewire for selection and use during the surgical procedure. See Spec. ¶[0030].
Regarding claim 20, the modified Brewer does not fully teach the surgical procedural task is a task that needs the measurement of the guidewire be obtained. Rather, as established regarding claim 15, the modified Brewer obtains a measurement of the guidewire using the integrated guidewire sizer and uses the same medical instrument to identify, organize, and present K-wires for operating-room use. Nadeau further teaches that K-wires and pins are available in numerous different diameter sizes and that the same diameter values are marked on both the measuring gauge and the corresponding organizational slots “for easy identification and organization” (Nadeau, pp. 6-8). However, the modified Brewer does not expressly teach using the guidewire measurement obtained with the integrated guidewire sizer to select or verify the guidewire before it is presented for use in the surgical procedure.
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 by using the guidewire diameter obtained with the integrated guidewire sizer to identify or verify the guidewire before selecting and presenting that guidewire for use during the surgical procedure. Nadeau teaches that K-wires and pins are available in numerous different diameter sizes, provides a measuring gauge together with organizational slots bearing corresponding diameter markings "for easy identification and organization," and presents the organized K-wires for selection and use in the operating room (Nadeau, pp. 6-8). The Instant Specification, in describing the state of the art in its Background, acknowledges that "It can be difficult, however, to determine a guidewire size based solely on visual inspection of the guidewires." Spec. ¶[0002]. That acknowledgment is taken as an admission of what was known to a person of ordinary skill in the art before the effective filing date. Because a K-wire's diameter cannot reliably be determined by visual inspection, correlating a particular K-wire with the corresponding diameter-marked location on Nadeau's rack (and thereby identifying the wire being selected) requires that the wire be measured. A person of ordinary skill would therefore have had reason to use the measuring gauge provided on Nadeau's rack to determine or verify the diameter of a K-wire as part of identifying, organizing, and selecting that wire for surgical use, thereby avoiding reliance on visual inspection and reducing the likelihood that a wire of an incorrect diameter would be selected. This use would have required no change to the established measuring, identification, organization, or presentation functions, because Nadeau already provides the measuring gauge, the corresponding diameter markings, and the K-wires together on the same tabletop rack for operating-room use. In the resulting method, the separate surgical procedural task of identifying, organizing, and presenting the guidewire for selection and use cannot be carried out without knowing the guidewire's diameter, such that the surgical procedural task requires the measurement of the guidewire to be obtained.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Brewer (U.S. Patent No. 1,389,486), hereinafter Brewer, and further in view of Nadeau (Kara Nadeau, “Safe and battle-ready,” Healthcare Purchasing News, Sept. 22, 2018, available at www.hpnonline.com/sterile-processing/article/13001349/safe-and-battle-ready (last accessed Aug. 19, 2026)), hereinafter Nadeau, as evidenced by AccessGUDID (AccessGUDID Device Record History for gSource model gS 98.5409, Public Device Record Key 47b193d4-6dfe-45e4-ad13-d4567f025e39, Public Version No. 1, Public Version Date October 5, 2020, available at www.accessgudid.nlm.nih.gov/devices/00840314247797 (last accessed Aug. 19, 2026)), hereinafter AccessGUDID.
The modified Brewer teaches the limitations of claim 1 as discussed above.
Regarding claim 21, the modified Brewer does not expressly disclose wherein the medical instrument is a sterilization tray or a screw caddy. Rather, Nadeau identifies the medical instrument relied upon regarding claim 1 as gSource's gRack for K-wires and pins, model gS 98.5409, which includes 12 slots for storage and organization of K-wires and pins, securely holds the K-wires and pins, and converts to a tabletop stand for use in the operating room (Nadeau, pp. 6-8). However, Nadeau does not expressly identify the gRack as a sterilization tray or screw caddy.
AccessGUDID documents the same gSource model gS 98.5409 identified by Nadeau. Public Version No. 1, dated October 5, 2020, identifies the brand as gSource, the model and catalog number as gS 98.5409, and the device as “gRack, K-Wire and Pin 12 1/2", holds 9" wires/pins 0.7mm - 4.5mm [.028" - .177"].” The same record assigns FDA Product Code FSM with the Product Code Name “Tray, Surgical, Instrument,” states that the device requires sterilization prior to use, and identifies moist heat or steam as the sterilization method.
Under the broadest reasonable interpretation consistent with the Specification, a sterilization tray encompasses a tray-type item that organizes and holds surgical instruments for use in a surgical procedure and for sterilization. The Specification expressly identifies a sterilization tray as an item used in a surgical procedure into which the guidewire sizer may be integrated. See Spec. ¶¶[0030]-[0031]. AccessGUDID identifies the same gSource gS 98.5409 gRack disclosed by Nadeau as “Tray, Surgical, Instrument” and states that it requires sterilization before use. Public Version No. 1 predates the effective filing date. Accordingly, Nadeau's gRack satisfies the sterilization-tray alternative of claim 21. AccessGUDID is relied upon as documentary evidence of the identity and classification of the same device, not to supply a separate physical modification of Nadeau's gRack.
Response to Arguments
Objections
Applicant's amendments filed 7/23/2026, and the accompanying remarks at page 6, regarding the previous Objections of claims 1, 8, 12-15, and 18-19 have been fully considered and are persuasive. The previous Objections have been withdrawn.
35 U.S.C. §112(b)
Applicant's amendments filed 7/23/2026, and the accompanying remarks at page 6, regarding the previous 112(b) Rejections of claims 12-14 have been fully considered and are persuasive. The previous 112(b) rejections have been withdrawn.
35 U.S.C. §103
Applicant's arguments filed 7/23/2026, pages 6-7, regarding the previous rejection of claims 1, 12, and 15 under 35 U.S.C. 103, have been fully considered but are not persuasive. The rejection of claims 1, 12, and 15 over Brewer in view of Hite is maintained on the grounds set forth above.
Applicant’s amendments necessitated the alternative grounds of rejection set forth in the present action. Claims 1, 12, and 15 were amended to newly require a surgical procedural task separate from the guidewire-sizing function. The alternative rejections over Brewer in view of Nadeau address that newly added limitation using Nadeau’s separate non-sizing functions of organizing, securely retaining, and presenting K-wires for selection and use during a surgical procedure.
For claims 1 and 15, the amendments to the dependent-claim structure independently necessitated the additional rejection paths. Subject matter previously recited in the sterilization-tray alternative of claim 3 was removed from claim 3 and presented in newly added claim 21, which depends from amended claim 1, thereby requiring reconsideration of the rejection path through claim 1. Claim 20 was amended to require the separate surgical procedural task to be a task that requires the guidewire measurement to be obtained, thereby requiring reconsideration of the rejection path through amended claim 15. The Brewer and Nadeau grounds address the claim paths and relationships produced by those amendments.
With respect to claim 12, the Examiner does not adopt Applicant’s narrower construction under which the recited “surgical procedural task separate from being a sizer” must be wholly unrelated to any sizing function. As explained above, the broadest reasonable interpretation requires the task to be separate from the guidewire-sizing function, but does not exclude sizing a different surgical component. Nevertheless, to fully address amended claim 12 under the narrower construction advanced by Applicant for the newly added limitation, claim 12 is alternatively rejected over Brewer in view of Nadeau. That alternative ground relies on Nadeau’s non-sizing functions of organizing, securely retaining, and presenting K-wires for selection and use during a surgical procedure. The alternative ground therefore does not constitute adoption of Applicant’s construction, but directly addresses the amended claim under the construction advocated by Applicant.
Applicant's Argument: Applicant argues that Brewer is directed to a general gauge for determining the gauge of articles such as wires, drills, and sheet materials and does not teach a medical instrument or a medical purpose for its gauge. Applicant notes that the previous Office Action acknowledged that Brewer does not expressly teach that its device is a medical instrument used in a surgical procedure to measure a medical guidewire.
Examiner's Response: Applicant is correct that Brewer alone does not expressly teach that Brewer's gauge is a medical instrument or that the measured wire is a surgical guidewire. This does not establish error in the rejection because the rejection does not rely on Brewer alone for that subject matter.
Brewer is relied upon for the stepped-width channel structure and associated wire-gauging operation. Hite is relied upon for applying such measurement to surgical guidewires. Hite teaches orthopedic surgical aids configured to determine dimensions of Kirschner wires and Steinmann pins. The previous Office Action therefore expressly recognized Brewer's deficiency and relied on Hite to provide the medical and surgical K-wire context.
Applicant's argument that Brewer itself lacks a medical purpose therefore does not identify a deficiency in the Brewer and Hite combination as actually applied.
Applicant's Argument: Applicant notes that the previous Office Action relied on Hite as teaching a unitary surgical aid that performs multiple surgical measurement functions, including measurement of orthopedic screws and wire diameters. Applicant argues, however, that Hite still has not been shown to teach a medical instrument that can “perform a surgical procedural task separate from being a sizer” and therefore does not cure Brewer's deficiency with respect to the newly added limitation.
Examiner's Response: Applicant's argument is not persuasive because a construction that excludes every additional sizing function is inconsistent with the amended claims read in light of the Specification.
Claim 1 first recites an “integrated guidewire sizer” and then requires the medical instrument to be further configured to perform “a surgical procedural task separate from being a sizer.” As set forth in the Claim Interpretation section of the present action, this limitation requires a surgical procedural task separate from the guidewire-sizing function of the previously recited integrated guidewire sizer. It does not require the second task to be unrelated to determining the size of a different surgical component with a different method.
The Specification directly supports this interpretation. Paragraph [0040] describes measuring the guidewire diameter and then states that the surgeon may subsequently perform a “separate surgical procedural task” using the same medical instrument, expressly identifying determining a screw size for installation as an example. Thus, the Specification itself identifies screw-size determination as a separate surgical procedural task following guidewire sizing even though screw-size determination also involves determining a size. Dependent claim 3 is consistent with this interpretation because it identifies a screw sizer as one of the recited medical instruments. A contrary construction that excluded every additional sizing function would exclude both paragraph [0040]'s express example and the screw-sizer species recited in claim 3, and therefore would not be the broadest reasonable interpretation consistent with the Specification.
Hite teaches a unitary orthopedic surgical aid that determines the diameter of Kirschner wires and Steinmann pins and also separately determines dimensions of orthopedic screws. The present rejection relies on the K-wire measurement function for the guidewire-sizing context and on the orthopedic screw-measuring function for the separate surgical procedural task. Hite's screw-measuring function is separate from determining the diameter of the guidewire and is the same type of task that the Specification expressly identifies as an example of a “separate surgical procedural task.”
Accordingly, the fact that Hite's additional function also involves determining a dimension does not establish that Hite fails to satisfy the amended limitation.
Claims 12 and 15
Applicant's arguments filed 7/23/2026, page 8, regarding the previous rejection of independent claims 12 and 15 under 35 U.S.C. 103 have been fully considered but are not persuasive. The rejection of claims 12 and 15 over Brewer in view of Hite is maintained, as revised to address the amended claim language. Separate alternative rejections of claims 12 and 15 over Brewer in view of Nadeau are set forth above.
Applicant's Argument: Applicant states that claims 12 and 15 differ in scope from claim 1 but include limitations similar to those discussed with respect to claim 1, and argues that claims 12 and 15 are patentable for at least the same reasons, where applicable. Applicant does not present a separate substantive prior-art argument for either claim.
Examiner's Response: The argument is not persuasive. Applicant relies on substantially the same arguments presented regarding claim 1. For the reasons discussed above, Brewer is not relied upon alone for the medical guidewire context, and Hite's orthopedic screw-measuring function provides a surgical procedural task separate from the guidewire-sizing function under the interpretation set forth in the present action. Applicant therefore has not established error in the rejection of claims 12 and 15 over Brewer in view of Hite.
Dependent Claims 2-6, 8-11, 13-14, and 16-19
Applicant's arguments filed 7/23/2026, page 8, regarding the previous rejection of claims 2-6, 8-11, 13-14, and 16-19 under 35 U.S.C. 103 have been fully considered but are not persuasive. The rejections of claims 2-6, 8-11, 13-14, and 16-19 are maintained on the grounds set forth above. The previous rejection of claim 20 over Brewer in view of Hite is not maintained in view of the amendment to claim 20. A separate present rejection of amended claim 20, necessitated by the amendment, is set forth above in view of Brewer and Nadeau.
Applicant's Argument: Applicant argues that claims 2-6, 8-11, 13-14, and 16-19 are patentable because they depend from allegedly allowable independent claims and because they recite their own unique combinations of features. Applicant further states that, although it has not addressed all issues concerning the dependent claims, it does not necessarily agree with the Examiner's characterization and assessment of those claims and believes each claim is patentable on its own merits.
Examiner's Response: The argument is not persuasive. For the reasons discussed above, Applicant has not established error in the rejection of claims 1, 12, or 15. The present rejections separately account for the additional limitations of claims 2-6, 8-11, 13-14, and 16-19. Applicant does not identify a specific error in the prior-art findings or obviousness reasoning applied to those additional limitations. The general assertion that the dependent claims contain unique patentable combinations therefore does not establish error in the presently stated rejections.
New Claim 21
Applicant's arguments filed 7/23/2026, pages 8-9, regarding newly added claim 21 have been fully considered but are not persuasive as to Applicant's reliance on the alleged patentability of claim 1. Claim 21 was newly added and was not subject to the previous rejection under 35 U.S.C. 103. A present rejection of claim 21 is set forth above.
Applicant's Argument: Applicant argues that claim 21 is patentable because it depends from allegedly patentable claim 1 and because it recites its own unique combination of features.
Examiner's Response: Applicant's reliance on the alleged patentability of claim 1 is not persuasive for the reasons discussed above. Claim 21 was newly added, so there is no previous rejection of claim 21 to maintain or withdraw. The additional subject matter of claim 21 is addressed in the separate present rejection set forth above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/AARON MERRIAM/Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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