DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the amendments received after a Non-Final Rejection on 15 October 2025. Claims 1-3, 7 and 10-27 are currently pending.
Claim Objections
Claim 1 is objected to because of the following informalities:
In line 22, it appears that the phrase “the driver” should read “a driver.”
In line 25, it appears that the phrase “a driver” should read “the driver.”
Claim 7 is objected to because of the following informality:
In line 2, it appears that the phrase “a surgical bending instrument” should read “the surgical bending instrument” for consistency.
Claim 11 is objected to because of the following informality:
In lines 1-2, it appears that the phrase “bound by a the first guide edge” should read “bound by the first guide edge.”
Claim 13 is objected to because of the following informalities:
In line 20, it appears that the phrase “the driver” should read “a driver.”
In line 26, it appears that the phrase “a driver” should read “the driver.”
Claim 23 is objected to because of the following informality:
In line 19, it appears that the phrase “wherein the central portion that includes” should read “wherein the central portion includes.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 10-12 and 17-27 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 10 recites the limitation "The bowed plate of claim 8" in line 1. Since claim 8 has been canceled, there is insufficient antecedent basis for this limitation in the claim.
Note: It appears that amending line 1 of claim 10 to read “The bowed plate of claim 1” would overcome this rejection. For examination purposes, claim 10 will be treated as reading as such.
Claim 11 recites the limitation "The bowed plate of claim 8" in line 1. Since claim 8 has been canceled, there is insufficient antecedent basis for this limitation in the claim. Since claim 12 is dependent upon claim 11, it contains the same issue.
Note: It appears that amending line 1 of claim 11 to read “The bowed plate of claim 1” would overcome this rejection. For examination purposes, claim 11 will be treated as reading as such.
Claim 17 recites the limitation “the backplate” in lines 19 and 24 (i.e. two separate instances). There is insufficient antecedent basis for this limitation in the claim. Since claims 18-22 are dependent upon claim 17, they contain the same issue.
Note: It appears that amending lines 19 and 24 of claim 17 to read “the central portion” would overcome this rejection. For examination purposes, claim 17 will be treated as reading as such.
Claim 23 recites the limitation “the backplate” in lines 22 and 27 (i.e. two separate instances). There is insufficient antecedent basis for this limitation in the claim. Since claims 24-27 are dependent upon claim 23, they contain the same issue.
Note: It appears that amending lines 22 and 27 of claim 23 to read “the central portion” would overcome this rejection. For examination purposes, claim 23 will be treated as reading as such.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 7, 10-13, 15-17, 19, 21-23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Amis et al. (U.S. Patent Application Publication 2020/0038076) in view of Hartdegen et al. (U.S. Patent Application Publication 2017/0196604).
Regarding claims 1-3, 7 and 10-12, Amis et al. disclose (as to part of claim 1) a bowed plate (5) capable of being used to fixate osteotomies and joint arthrodesis comprising a backplate (8) comprising a support portion (i.e. left-most portion of 8 including 9 and 11 as best seen in Figure 1) and an aperture portion (i.e. right-most portion of 8 including 10 and 12 as best seen in Figure 1) that share an intervening central portion (25); the aperture portion being capable of receiving a screw (20); a singular leg (9) extending from the support portion, capable of being implanted into a bone hole (see paragraph 0049), wherein the leg comprises one or more fixation features (i.e. barbs) biased toward the backplate (i.e. due to the free end of the leg being angled toward a central axis of the plate (see Figure 4), the fixation features facing the central axis are biased toward the backplate) and capable of enabling the leg to grip an inner wall of a bone hole (see paragraph 0036), wherein the central portion comprises a curvature (see Figure 4) that angles the leg (i.e. an axis extending longitudinally through the center of 9) and a centerline (i.e. centerline defined by an axis extending longitudinally through the center of 12) of a slanted aperture (12) toward a midline (i.e. midline defined through the center of 5 and from top-to-bottom as best seen in Figure 4) of the bowed plate, wherein upon being placed into a straightened configuration (i.e. configuration as best seen in Figures 6 and 9), the curvature of the central portion may be straightened (i.e. via 95) such that the leg and the centerline of the slanted aperture become parallel to one another (i.e. in the configuration as best seen in Figure 6, see paragraph 0040), wherein the leg is joined to the support portion using a tapered portion (i.e. tapered portions located at 30 and 31 as best seen in Figure 4), wherein the tapered portion is capable of strengthening the leg with respect to the support portion (i.e. although not explicitly stated in the prior art reference, Figure 4 shows that the tapered portion is defined by an addition of material as the leg transitions to the support portion; this addition of material would inherently provide additional strength given the entirety of the bowed plate can be made from the same material), wherein the central portion is capable of respectively accommodating a first grip (107/108) and a second grip (109) comprising a surgical bending instrument (95) capable of straightening the bowed plate (see paragraphs 0045-0051), and wherein the first grip and the second grip extend across a majority of the width of the backplate (see Figure 14), wherein (as to claim 2) the one or more fixation features include teeth (i.e. barbs, see Figure 4 and paragraph 0036), wherein (as to claim 3) the bowed plate comprises nitinol (see paragraph 0036), and wherein (as to claim 7) the central portion is capable of being straightened by way of a surgical bending instrument (95) for placement at a bone fixation or fusion site of a patient (see Figures 13-15) (see Figures 1-17, and paragraphs 0036-0054).
Amis et al. disclose the claimed invention except for wherein (as to the remainder of claim 1) the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the backplate, wherein advancing a driver exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate, wherein the notches and a first and second guide edge are capable of positioning the driver, wherein (as to claim 10) the central portion is capable of facilitating removing the first grip and the second grip from between a bone surface and the backplate after implantation of the bowed plate into a bone, wherein (as to claim 11) the central portion is bound by the first guide edge and the second guide edge that cooperate to center the bowed plate between the first grip and the second grip of the surgical bending instrument, and wherein (as to claim 12) the first notch and the second notch and the first guide edge and the second guide edge are configured to position a driver of the surgical bending instrument at a location of the central portion that is optimal for straightening the bowed plate.
Hartdegen et al. teach the use of a bowed plate (120) capable of being used to fixate osteotomies and joint arthrodesis comprising a backplate (120) comprising a support portion (i.e. left-most instance of 129 as best seen in Figure 3) and an aperture portion (i.e. right-most instance of 129 as best seen in Figure 3) that share an intervening central portion (124), wherein the central portion includes a first notch (i.e. left-most instance of 122 as best seen in Figure 3) and a second notch (i.e. right-most instance of 122 as best seen in Figure 3) that are capable of respectively accommodating a first grip (102a) and a second grip (102b) comprising a surgical bending instrument (100) for straightening the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width (i.e. width and extension as best seen in Figure 2C) of the backplate (see Figure 6), wherein advancing a driver (104a or 104b, i.e. advancing either 104a toward 104b or 104b toward 104a into the position as best seen in Figure 1E) exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening (i.e. to the position as best seen in Figure 1E) of the central portion of the bowed plate, wherein the central portion is capable of facilitating removing the first grip and the second grip from between a bone surface and the backplate after implantation of the bowed plate into a bone (i.e. due to the locations of the first and second notches, see Figure 2D), wherein the central portion is bound by a first guide edge (i.e. edge defined by left-most instance of 122 as best seen in Figure 3) and a second guide edge (i.e. edge defined by right-most instance of 122 as best seen in Figure 3) that cooperate to center the bowed plate between the first grip and the second grip of the surgical bending instrument (see Figure 2D), and wherein the first notch and the second notch and the first guide edge and the second guide edge are configured to position the driver of the surgical bending instrument at a location of the central portion that is optimal for straightening the bowed plate (i.e. straightened configuration as best seen in Figure 1E) (see Figures 1A-10C, and paragraphs 0109-0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Amis et al. with wherein the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the backplate, wherein advancing a driver exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate, wherein the notches and a first and second guide edge are capable of positioning the driver, wherein the central portion is capable of facilitating removing the first grip and the second grip from between a bone surface and the backplate after implantation of the bowed plate into a bone, wherein the central portion is bound by the first guide edge and the second guide edge that cooperate to center the bowed plate between the first grip and the second grip of the surgical bending instrument, and wherein the first notch and the second notch and the first guide edge and the second guide edge are configured to position a driver of the surgical bending instrument at a location of the central portion that is optimal for straightening the bowed plate in view of Hartdegen et al. in order to provide an alternative, well-known and obvious plate configuration and surgical bending instrument for both bending the bowed plate into an insertion configuration and precisely guiding a screw into the aperture portion and into bone to yield predictable results.
Regarding claims 13 and 15-16, Amis et al. disclose (as to part of claim 13) a bowed plate (250) capable of being used to fixate osteotomies and joint arthrodeses comprising a backplate (280) comprising a central portion (295) having a first end (i.e. end defined by 300 and 302) and a second end (i.e. end defined by 301 and 303); a support portion (i.e. portion extending from 300) joined with the first end; a first aperture portion (i.e. portion extending from 301) joined with the second end, the first aperture portion capable of receiving a screw (i.e. via 292, see paragraph 0060); a leg (281) extending from the support portion via a tapered portion (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing tapered portions at 30 and 31), capable of being implanted into a bone hole (see paragraph 0062); wherein the leg comprises one or more teeth (i.e. barbs, see Figure 19) and one or more fixation features (e.g. a plurality of grooves, see Figure 19) capable of enabling the leg to grip an inner wall of the bone hole (see paragraph 0062); wherein the central portion comprises a curvature (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing a curvature) that angles the leg (i.e. an axis extending longitudinally through the center of 281) and a centerline (i.e. centerline defined by an axis extending longitudinally through the center of 292) of a slanted aperture (292) toward a midline (i.e. midline defined through the center of 250 and from top-to-bottom as best seen in Figure 19) of the bowed plate, wherein upon being placed into a straightened configuration (i.e. configuration as best illustrated in Figures 6 and 9), the curvature of the central portion may be straightened (i.e. via 95) such that the leg and the centerline of the slanted aperture become parallel to one another (i.e. in the configuration as best illustrated in Figure 6, see paragraph 0061); and a second aperture portion (i.e. portion extending from 303) joined with the second end, wherein the central portion is capable of respectively accommodating a first grip (107/108) and a second grip (109) comprising a surgical bending instrument (95) capable of straightening the bowed plate (see paragraphs 0045-0051), and wherein the first grip and the second grip extend across a majority of the width of the backplate (see Figure 14), wherein (as to claim 15) each of the first aperture portion and the second aperture portion includes a slanted aperture (292 and 294) (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing where 12 would be slanted relative to a midline of 5), and wherein (as to claim 16) the support portion comprises a third aperture portion (i.e. portion defined by portion extending from 300 and defining 291 as best seen in Figure 19) that includes a slanted aperture (291) (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing where 11 would be slanted relative to a midline of 5) for receiving a bone screw (see paragraph 0060) (see Figures 1-17 and 19, and paragraphs 0036-0054 and 0059-0062).
Amis et al. disclose the claimed invention except for wherein (as to the remainder of claim 13) the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, wherein advancing a driver exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the backplate, and wherein the notches and a first and second guide edge are capable of positioning the driver.
Hartdegen et al. teach the use of a bowed plate (120) capable of being used to fixate osteotomies and joint arthrodesis comprising a backplate (120) comprising a support portion (i.e. left-most instance of 129 as best seen in Figure 3) and an aperture portion (i.e. right-most instance of 129 as best seen in Figure 3) that share an intervening central portion (124), wherein the central portion includes a first notch (i.e. left-most instance of 122 as best seen in Figure 3) and a second notch (i.e. right-most instance of 122 as best seen in Figure 3) that are capable of respectively accommodating a first grip (102a) and a second grip (102b) comprising a surgical bending instrument (100) for straightening the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width (i.e. width and extension as best seen in Figure 2C) of the backplate (see Figure 6), wherein advancing a driver (104a or 104b, i.e. advancing either 104a toward 104b or 104b toward 104a into the position as best seen in Figure 1E) exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening (i.e. to the position as best seen in Figure 1E) of the central portion of the bowed plate, wherein the central portion is bound by a first guide edge (i.e. edge defined by left-most instance of 122 as best seen in Figure 3) and a second guide edge (i.e. edge defined by right-most instance of 122 as best seen in Figure 3), wherein the first notch and the second notch and the first guide edge and the second guide edge are configured to position a driver (104a or 104b) of the surgical bending instrument (see Figures 1A-10C, and paragraphs 0109-0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Amis et al. with wherein the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, wherein advancing a driver exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the backplate, and wherein the notches and a first and second guide edge are capable of positioning the driver in view of Hartdegen et al. in order to provide an alternative, well-known and obvious plate configuration and surgical bending instrument for both bending the bowed plate into an insertion configuration and precisely guiding a screw into the aperture portion and into bone to yield predictable results.
Regarding claims 17 and 19, in a first interpretation, Amis et al. disclose (as to part of claim 17) a bowed plate assembly (250) capable of being used to fixate osteotomies and joint arthrodeses comprising a central portion (280) disposed between a first aperture portion (i.e. portion extending from 300) comprising a slanted aperture (291) (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing where 11/12 would be slanted relative to a midline of 5) and a second aperture portion (i.e. portion extending from 303), the first aperture portion being capable of receiving a bone screw (i.e. via 291, see paragraph 0060); the central portion comprising a curvature (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing a curvature) that angles a leg (281) and a centerline (i.e. central axis defined along and through center of 291) of the slanted aperture toward a midline (i.e. central axis defined along and through center of 250) of the bowed plate assembly; wherein upon being placed into a straightened configuration (i.e. configuration as best illustrated in Figures 6 and 9), the curvature of the central portion may be straightened (i.e. via 95) such that the leg and the centerline of the slanted aperture become parallel to one another (i.e. in the configuration as best illustrated in Figure 6, see paragraph 0061); one or more legs (281 and a screw located within 291) coupled with the first aperture portion; and one or more legs (284 and a screw located within 294) coupled with the second aperture portion, wherein at least one (e.g. 281 and 284) of the one or more legs comprises one or more fixation features (i.e. barbs) biased toward the central portion (i.e. due to the free end of the leg being angled toward a central axis of the plate (see Figures 4 and 19), the fixation features facing the central axis are biased toward the central portion), and wherein one or more legs (e.g. 282 or 283) comprises a tapered portion (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing tapered portions at 30 and 31) to couple with a support portion (e.g. portion extending from 301 or portion extending from 302), wherein the central portion is capable of respectively accommodating a first grip (107/108) and a second grip (109) comprising a surgical bending instrument (95) capable of straightening the bowed plate assembly (see paragraphs 0045-0051), and wherein the first grip and the second grip extend across a majority of the width of the central portion (see Figure 14), wherein (as to claim 19) any one of the one or more legs (e.g. a screw located within 294) comprises a support portion (i.e. portion defined by a head of the screw, see Figure 1) that is capable of being threaded into a threaded aperture (294) disposed within the second aperture portion (see Figures 1-17 and 19, and paragraphs 0036-0054 and 0059-0062).
Amis et al. disclose the claimed invention except for wherein (as to the remainder of claim 17) the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate assembly, wherein advancing a driver exerts an increasing degree of force onto the central portion by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate assembly, wherein the first notch and the second notch serve to center the bowed plate assembly within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the central portion, and wherein the notches and a first and second guide edge are capable of positioning the driver.
Hartdegen et al. teach the use of a bowed plate assembly (120) capable of being used to fixate osteotomies and joint arthrodesis comprising a backplate (120) comprising a support portion (i.e. left-most instance of 129 as best seen in Figure 3) and an aperture portion (i.e. right-most instance of 129 as best seen in Figure 3) that share an intervening central portion (124), wherein the central portion includes a first notch (i.e. left-most instance of 122 as best seen in Figure 3) and a second notch (i.e. right-most instance of 122 as best seen in Figure 3) that are capable of respectively accommodating a first grip (102a) and a second grip (102b) comprising a surgical bending instrument (100) for straightening the bowed plate, wherein advancing a driver (104a or 104b, i.e. advancing either 104a toward 104b or 104b toward 104a into the position as best seen in Figure 1E) exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening (i.e. to the position as best seen in Figure 1E) of the central portion of the bowed plate, wherein the first notch and the second notch serve to center the bowed plate assembly within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width (i.e. width and extension as best seen in Figure 2C) of the central portion (see Figure 6), wherein the central portion is bound by a first guide edge (i.e. edge defined by left-most instance of 122 as best seen in Figure 3) and a second guide edge (i.e. edge defined by right-most instance of 122 as best seen in Figure 3), wherein the first notch and the second notch and the first guide edge and the second guide edge are configured to position the driver of the surgical bending instrument (see Figures 1A-10C, and paragraphs 0109-0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Amis et al. with wherein the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate assembly, wherein advancing a driver exerts an increasing degree of force onto the central portion by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate assembly, wherein the first notch and the second notch serve to center the bowed plate assembly within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the central portion, and wherein the notches and a first and second guide edge are capable of positioning the driver in view of Hartdegen et al. in order to provide an alternative, well-known and obvious plate configuration and surgical bending instrument for both bending the bowed plate assembly into an insertion configuration and precisely guiding a screw into the aperture portion and into bone to yield predictable results.
Regarding claims 17 and 21-22, in a second interpretation, Amis et al. disclose (as to part of claim 17) a bowed plate assembly (250) capable of being used to fixate osteotomies and joint arthrodeses comprising a central portion (280) disposed between a first aperture portion (i.e. portion extending from 300 and 302) comprising a slanted aperture (291 or 293) (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing where 11/12 would be slanted relative to a midline of 5) and a second aperture portion (i.e. portion extending from 301 and 303), the first aperture portion being capable of receiving a bone screw (i.e. via 291 or 293, see paragraph 0060); the central portion comprising a curvature (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing a curvature) that angles a leg (281 or 283) and a centerline (i.e. central axis defined along and through center of 291 or center of 293) of the slanted aperture toward a midline (i.e. central axis defined along and through center of 250) of the bowed plate assembly; wherein upon being placed into a straightened configuration (i.e. configuration as best illustrated in Figures 6 and 9), the curvature of the central portion may be straightened (i.e. via 95) such that the leg and the centerline of the slanted aperture become parallel to one another (i.e. in the configuration as best illustrated in Figure 6, see paragraph 0061); one or more legs (281 or 283 and a screw located within 291 or 293) coupled with the first aperture portion; and one or more legs (282 or 284 and a screw located within 292 or 294) coupled with the second aperture portion, wherein at least one (e.g. 281, 282, 283, or 284) of the one or more legs comprises one or more fixation features (i.e. barbs) biased toward the central portion (i.e. due to the free end of the leg being angled toward a central axis of the plate (see Figures 4 and 19), the fixation features facing the central axis are biased toward the central portion, and wherein one or more legs (e.g. 281, 282, 283, or 284) comprises a tapered portion (see paragraph 0059 referring to 250 being identical in design to 5, and Figure 4 showing tapered portions at 30 and 31) to couple with a support portion (e.g. portion extending wherein 281, 282, 283, or 284 engages 250), wherein the central portion is capable of respectively accommodating a first grip (107/108) and a second grip (109) comprising a surgical bending instrument (95) capable of straightening the bowed plate assembly (see paragraphs 0045-0051), and wherein the first grip and the second grip extend across a majority of the width of the central portion (see Figure 14), wherein (as to claim 21) the first aperture portion includes side-by-side aperture portions (i.e. portions extending from 300 and 302 are side-by-side as best seen in Figure 19), and wherein (as to claim 22) the second aperture portion includes one or more in-line aperture portions (i.e. the portion extending from 301 is in-line with the portion extending from 300, the portion extending from 301 is in-line with the portion extending from 303, and the portion extending from 303 is in-line with the portion extending from 302) (see Figures 1-17 and 19, and paragraphs 0036-0054 and 0059-0062).
Amis et al. disclose the claimed invention except for wherein (as to the remainder of claim 17) the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, wherein advancing a driver exerts an increasing degree of force onto the central portion by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate assembly, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the central portion, and wherein the notches and a first and second guide edge are capable of positioning the driver.
Hartdegen et al. teach the use of a bowed plate (120) capable of being used to fixate osteotomies and joint arthrodesis comprising a backplate (120) comprising a support portion (i.e. left-most instance of 129 as best seen in Figure 3) and an aperture portion (i.e. right-most instance of 129 as best seen in Figure 3) that share an intervening central portion (124), wherein the central portion includes a first notch (i.e. left-most instance of 122 as best seen in Figure 3) and a second notch (i.e. right-most instance of 122 as best seen in Figure 3) that are capable of respectively accommodating a first grip (102a) and a second grip (102b) comprising a surgical bending instrument (100) for straightening the bowed plate, wherein advancing a driver (104a or 104b, i.e. advancing either 104a toward 104b or 104b toward 104a into the position as best seen in Figure 1E) exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening (i.e. to the position as best seen in Figure 1E) of the central portion of the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width (i.e. width and extension as best seen in Figure 2C) of the backplate (see Figure 6), wherein the central portion is bound by a first guide edge (i.e. edge defined by left-most instance of 122 as best seen in Figure 3) and a second guide edge (i.e. edge defined by right-most instance of 122 as best seen in Figure 3), wherein the first notch and the second notch and the first guide edge and the second guide edge are configured to position the driver of the surgical bending instrument (see Figures 1A-10C, and paragraphs 0109-0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the invention of Amis et al. with wherein the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, wherein advancing a driver exerts an increasing degree of force onto the central portion by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate assembly, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the central portion, and wherein the notches and a first and second guide edge are capable of positioning the driver in view of Hartdegen et al. in order to provide an alternative, well-known and obvious plate configuration and surgical bending instrument for both bending the bowed plate into an insertion configuration and precisely guiding a screw into the aperture portion and into bone to yield predictable results.
Regarding claims 23 and 25-27, Amis et al. disclose (as to part of claim 23) a method for fixating a bone fusion site (see Figure 17) of a patient comprising drilling a first bone hole (i.e. for receiving 9 or 10) at the bone fusion site; drilling a second bone hole (i.e. for receiving 19 or 20) across the bone fusion site (see paragraphs 0049 and 0053); straightening a bowed plate (8) by way of a surgical bending instrument (95) (see paragraphs 0046 and 0047); inserting a leg (9 or 10) comprising the bowed plate into the first bone hole (see paragraph 0049), the leg extending from a support portion (i.e. portion of 25 defined at the intersection of 9 and 25, or the intersection of 10 and 25), wherein the leg is joined to the support portion using a tapered portion (i.e. tapered portions located at 30 and 31 as best seen in Figure 4), capable of being implanted into a bone hole (see paragraph 0049); including a central portion (25) comprising a curvature (see Figure 4) that angles the leg and a centerline (i.e. centerline defined by an axis extending longitudinally through the center of 12) of a slanted aperture (12) toward a midline () of the bowed plate (i.e. midline defined through the center of 5 and from top-to-bottom as best seen in Figure 4); straightening the curvature of the central portion (i.e. via 95) such that the leg and the centerline of the slanted aperture are parallel to one another (i.e. in the configuration as best seen in Figure 6, see paragraph 0040), wherein the leg comprises one or more fixation features (i.e. barbs, see paragraph 0036); extending a bone screw (19 or 20) through an aperture portion (i.e. portion of 8 defining 11 or 12) of the bowed plate (see paragraph 0053); tightening the bone screw into the second bone hole (see paragraph 0053); relaxing the bowed plate such that the leg and the bone screw compress the bone fusion site (see paragraphs 0049 and 0050); removing the surgical bending instrument from between the bone fusion site and the bowed plate (see paragraphs 0049 and 0050), wherein the central portion is capable of respectively accommodating a first grip (107/108) and a second grip (109) comprising a surgical bending instrument (95) capable of straightening the bowed plate assembly (see paragraphs 0045-0051), and wherein the first grip and the second grip extend across a majority of the width of the central portion (see Figure 14), wherein (as to claim 25) tightening includes causing the aperture portion and a support portion (30 or 31) to contact the bone fusion site (see Figure 17, and paragraph 0053), wherein (as to claim 26) relaxing includes reducing a degree of force applied to the bowed plate by the surgical bending instrument (see paragraph 0050), and wherein (as to claim 27) straightening includes loading the bowed plate into the surgical bending instrument (see Figure 13, and paragraph 0046); activating the surgical bending instrument to forcibly clasp (i.e. via 107, 108, and 109) the bowed plate (see paragraph 0046); and operating the surgical bending instrument to manipulate (i.e. via 102) the bowed plate from a bowed configuration (i.e. configuration as best seen in Figure 13) to a straightened configuration (i.e. configuration as best seen in Figure 14) (see paragraph 0046) (see Figures 1-17, and paragraphs 0036-0054).
Amis et al. disclose the claimed method except for wherein (as to the remainder of claim 23) the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, advancing a driver that exerts an increasing degree of force onto the central portion by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the central portion, and wherein the notches and a first and second guide edge are capable of positioning the driver.
Hartdegen et al. teach the use of a bowed plate (120) capable of being used to fixate osteotomies and joint arthrodesis comprising a backplate (120) comprising a support portion (i.e. left-most instance of 129 as best seen in Figure 3) and an aperture portion (i.e. right-most instance of 129 as best seen in Figure 3) that share an intervening central portion (124), wherein the central portion includes a first notch (i.e. left-most instance of 122 as best seen in Figure 3) and a second notch (i.e. right-most instance of 122 as best seen in Figure 3) that are capable of respectively accommodating a first grip (102a) and a second grip (102b) comprising a surgical bending instrument (100) for straightening the bowed plate, advancing a driver (104a or 104b, i.e. advancing either 104a toward 104b or 104b toward 104a into the position as best seen in Figure 1E) exerts an increasing degree of force onto the backplate by the first grip, second grip, and the driver, thereby causing a corresponding straightening (i.e. to the position as best seen in Figure 1E) of the central portion of the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width (i.e. width and extension as best seen in Figure 2C) of the backplate (see Figure 6), wherein the central portion is bound by a first guide edge (i.e. edge defined by left-most instance of 122 as best seen in Figure 3) and a second guide edge (i.e. edge defined by right-most instance of 122 as best seen in Figure 3), wherein the first notch and the second notch and the first guide edge and the second guide edge are configured to position the driver of the surgical bending instrument (see Figures 1A-10C, and paragraphs 0109-0117).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Amis et al. with wherein the central portion includes a first notch and a second notch that are capable of respectively accommodating a first grip and a second grip comprising a surgical bending instrument for straightening the bowed plate, advancing a driver that exerts an increasing degree of force onto the central portion by the first grip, second grip, and the driver, thereby causing a corresponding straightening of the central portion of the bowed plate, wherein the first notch and the second notch serve to center the bowed plate within the surgical bending instrument and enable the first grip and the second grip to extend across a majority of the width of the central portion, and wherein the notches and a first and second guide edge are capable of positioning the driver in view of Hartdegen et al. in order to provide an alternative, well-known and obvious plate configuration and surgical bending instrument for both bending the bowed plate into an insertion configuration and precisely guiding a screw into the aperture portion and into bone to yield predictable results.
Claims 14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Amis et al. (U.S. Patent Application Publication 2020/0038076) in view of Hartdegen et al. (U.S. Patent Application Publication 2017/0196604), as applied to claims 13 and 17 above respectively, further in view of Herzog et al. (U.S. Patent 6,187,009).
Regarding claim 14, Amis et al. in view of Hartdegen et al. disclose the claimed invention except for wherein the leg includes one or more circumferential grooves, threads, or any combination thereof.
Herzog et al. teach the use of a plate (1) capable of being used to fixate osteotomies and joint arthrodeses comprising a leg (4) extending from the plate, wherein the leg comprises one or more teeth (16) and one or more circumferential grooves (see Figure 8) (see Figures 1-2 and 8, and column 3, lines 1-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Amis et al. in view of Hartdegen et al. with wherein the leg includes one or more circumferential grooves, threads, or any combination thereof in view of Herzog et al. in order to provide an alternative, well-known and obvious means for securely retaining the bowed plate within bone.
Regarding claim 18, Amis et al. in view of Hartdegen et al. disclose the claimed invention except for wherein any one of the one or more legs includes one or more circumferential teeth that are biased toward the central portion.
Herzog et al. teach the use of a plate (1) capable of being used to fixate osteotomies and joint arthrodeses comprising a leg (4) extending from the plate, wherein the leg comprises one or more circumferential teeth (16) that are biased toward the plate (see Figure 8) (see Figures 1-2 and 8, and column 3, lines 1-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Amis et al. in view of Hartdegen et al. with wherein any one of the one or more legs includes one or more circumferential teeth that are biased toward the central portion in view of Herzog et al. in order to provide an alternative, well-known and obvious means for securely retaining the bowed plate within bone.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Amis et al. (U.S. Patent Application Publication 2020/0038076) in view of Hartdegen et al. (U.S. Patent Application Publication 2017/0196604), as applied to claim 19 above, further in view of Hearn (U.S. Patent 8,221,421).
Amis et al. disclose wherein (as to part of claim 20) the support portion includes a flat top surface (i.e. surface as best seen in Figure 1) and the aperture portion includes a threaded aperture (see Figure 1).
Amis et al. in view of Hartdegen et al. disclose the claimed invention except for wherein (as to the remainder of claim 20) the flat top portion is surrounded by tapered peripheral threads that are capable of engaging with threads comprising the threaded aperture.
Hearn et al. teach the use of a plate (12) comprising a threaded aperture (22), and a leg (42) comprising a support portion (44) capable of being threaded into the threaded aperture, wherein the support portion includes a flat top surface (i.e. top-most surface of 44 as best seen in Figure 19) surrounded by tapered peripheral threads (see Figure 19) that are capable of engaging threads (i.e. threads defined by 22) comprising the threaded aperture (see Figures 3-4 and 19, and column 5, lines 17-25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Amis et al. in view of Hartdegen et al. with wherein the flat top portion is surrounded by tapered peripheral threads that are capable of engaging with threads comprising the threaded aperture in view of Hearn et al. in order to provide a well-known, obvious means for preventing removal of the support portion from the first aperture portion.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Amis et al. (U.S. Patent Application Publication 2020/0038076) in view of Hartdegen et al. (U.S. Patent Application Publication 2017/0196604), as applied to claim 23 above.
Amis et al. disclose drilling the second bone hole after inserting the leg and after aligning a slanted aperture (11 or 12, i.e. slant as best seen in Figure 4) with the bone (see paragraph 0053).
Amis et al. in view of Hartdegen et al. disclose the claimed method except for wherein inserting the leg includes aligning the slanted aperture with the second bone hole.
One having ordinary skill in the art would recognize that an alternative method would include drilling the second bone hole prior to inserting the leg. Doing so would allow for the slanted aperture to be then be aligned with the second bone hole to yield predictable results.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Amis et al. in view of Hartdegen et al. with wherein inserting the leg includes aligning the slanted aperture with the second bone hole in order to provide a predictable means for aligning the slanted aperture with the second bone hole.
Response to Arguments
The applicant's arguments filed 15 October 2025 have been fully considered but they are not persuasive.
On numbered pages 13-14, the applicant argues that Amis et al. does not disclose/teach one singular aperture and one singular leg. The examiner respectfully disagrees. The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). Therefore, the fact that the device disclosed by Amis et al. includes/contains additional elements (e.g. an additional aperture and an additional leg) is irrelevant to the currently claimed invention. Therefore, it is the examiner's position that Amis et al. discloses the device as claimed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775