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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03 February 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 26 January 2026. As directed by the amendment: claims 1, 6-8, 13-16, 20-23, 25, and 27 have been amended, claims 2-5, 10, 12, 17-19, and 26 are cancelled, and claims 28-30 are newly added. Claims 1, 6-9, 11, 13-16, 20-25, and 27-30 currently stand pending in the application.
The amendments to the claims are not sufficient to overcome the specification objections listed in the previous action, which are repeated below in relevant part, in addition to further specification objections necessitated by the claim amendments.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are correspondingly withdrawn. The cancellation of claim 26 has rendered moot its relevant claim objection. Further claim objections necessitated by the claim amendments are presented below.
The cancellation of claim 26 has rendered moot its relevant rejections under 35 U.S.C. 112(a) and (b), which are correspondingly withdrawn. The amendments to claim 27 are sufficient to overcome the relevant rejection under 35 U.S.C. 112(a), which is correspondingly withdrawn. However, further rejections under 35 U.S.C. 112(a) are presented below, as necessitated by the claim amendments.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(d) listed in the previous action, which are correspondingly withdrawn.
Response to Arguments
Applicant's arguments filed 26 January 2026 have been fully considered but they are not persuasive. As to the rejections under 35 U.S.C. 102/103, Applicant contends that Strohkirch et al. (WO 2021/126326) fails to disclose that the rod is at least partially covered by the hand grip. Examiner respectfully submits that in the following interpretation in which the rod 4262 includes the ball and post extending from the ball, the rod is at least partially covered by the hand grip. Strohkirch is not used to reject new claims 28 and 29.
Applicant’s arguments with respect to the rejections under Grusin et al. (US 6,283,969) have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claim 1, the specification does not provide proper antecedent basis for the limitation that the ratio of R to D is between 0.3 to 0.7. The specification recites that the ratio of R/D ranges from 0.3 to 0.7 (par. [0062]), which implies inclusion of the upper and lower bounds of the range, whereas the limitation between 0.3 to 0.7 implies that the upper and lower bounds of the range are not included.
As to claim 6, the specification does not provide proper antecedent basis for the limitations that the ratio of H/R is between 1.5 to 1.7, and the ratio of D/G is between 1.5 to 2.5. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 7, the specification does not provide proper antecedent basis for the limitations that the ratio of H/R is between 1.3 to 1.9, and the ratio of D/G is between 1.0 to 5.0. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 8, the specification does not provide proper antecedent basis for the limitations that the ratio of H/R is between 1.0 to 2.0, and the ratio of D/G is between 0.1 to 10.0. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 9, the specification does not provide proper antecedent basis for the limitations that the ratio of R/D is about 0.5; the ratio of H/R is about 1.6; the ratio of D/G is about 2.0. The specification recites these values (par. [0061]) but does not recite them as about 0.5, about 1.6, or about 2.0.
As to claim 13, the specification does not provide proper antecedent basis for the limitation that the ratio of R’ to D’ is between 0.7 and 0.9. The specification recites that the ratio of R’/D’ ranges from 0.7 and 0.9 (par. [0064]), which implies inclusion of the upper and lower bounds of the range, whereas the limitation between 0.7 and 0.9 implies that the upper and lower bounds of the range are not included.
As to claim 14, the specification does not provide proper antecedent basis for the limitations that the ratio of H'/R' is between 1.5 to 1.7, and the ratio of D'/G' is between 1.2 to 1.3. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 15, the specification does not provide proper antecedent basis for the limitations that the ratio of H'/R' is between 1.3 to 1.9, and the ratio of D'/G' is between 1.0 to 2.0. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 16, the specification does not provide proper antecedent basis for the limitations that the ratio of H'/R' is between 1.0 to 2.0, and the ratio of D'/G' is between 0.1 to 10.0. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 20, the specification does not provide proper antecedent basis for the limitation that the ratio of R to D is between 0.7 and 0.9. The specification recites that the ratio of R/D ranges from 0.7 and 0.9 (par. [0064]), which implies inclusion of the upper and lower bounds of the range, whereas the limitation between 0.7 and 0.9 implies that the upper and lower bounds of the range are not included.
As to claim 21, the specification does not provide proper antecedent basis for the limitations that the ratio of H/R is between 1.5 to 1.7, and the ratio of D/G is between 1.2 to 1.3. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 22, the specification does not provide proper antecedent basis for the limitations that the ratio of H/R is between 1.3 to 1.9, and the ratio of D/G is between 1.0 to 2.0. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 23, the specification does not provide proper antecedent basis for the limitations that the ratio of H/R is between 1.0 to 2.0, and the ratio of D/G is between 0.1 to 10.0. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
As to claim 24, the specification does not provide proper antecedent basis for the limitations that the ratio of R/D is about 0.8; the ratio of H/R is about 1.6; the ratio of D/G is about 1.25. The specification recites these values (par. [0063]) but does not recite them as about 0.8, about 1.6, or about 1.25.
As to claim 25, the specification does not provide proper antecedent basis for the limitations that the ratio of H/R is between 1.0 to 8.0, and the ratio of D/G is between 0.1 to 10.0. The specification recites that the ratios range from these values, which implies inclusion of the upper and lower bounds of the range, whereas the term between implies that the upper and lower bounds of the range are not included.
Claim Objections
Claims 6-8, 14, 21-23, and 25 are objected to because of the following informalities: improper antecedence and punctuation. Appropriate correction is required. The following amendments are suggested:
Claim 6 / line 2: “wherein the ratio of H/R”
Claim 7 / line 2: “wherein the ratio of H/R”
Claim 8 / line 2: “wherein the ratio of H/R”
Claim 14 / line 2: “wherein the ratio of H’/R’”
Claim 21 / line 2: “wherein the ratio of H/R”
Claim 22 / line 2: “wherein the ratio of H/R”
Claim 23 / line 2: “wherein the ratio of H/R”
Claim 25 / line 2: “wherein the ratio of H/R”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6, 8, 15, 16, 22, 23, 25, 28, and 29 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claim 6, the limitations that the ratio of H/R is between 1.5 to 1.7, and the ratio of D/G is between 1.5 to 2.5, is not supported by the specification as originally filed in the same embodiment that has the ratio of R to D between 0.3 to 0.7, as required by claim 1. The specification recites that these ranges of H/R and D/G are in an embodiment when the ratio of R/D ranges from 0.4 to 0.6 (par. [0062]). The embodiments are presented as alternates.
As to claim 8, the limitations that the ratio of H/R is between 1.0 to 2.0, and the ratio of D/G is between 0.1 to 10.0, is not supported by the specification as originally filed in the same embodiment that has the ratio of R to D between 0.3 to 0.7, as required by claim 1. The specification recites that these ranges of H/R and D/G are in an embodiment when the ratio of R/D ranges from 0.2 to 1.0 (par. [0062]). The embodiments are presented as alternates.
As to claim 15, the limitations that the ratio of H'/R' is between 1.3 to 1.9, and the ratio of D'/G' is between 1.0 to 2.0, is not supported by the specification as originally filed in the same embodiment that has the ratio of R’ to D’ between 0.7 and 0.9, as required by claim 13. The specification recites that these ranges of H'/R' and D'/G' are in an embodiment when the ratio of R’/D’ ranges from 0.6 to 1.0 (par. [0064]). The embodiments are presented as alternates.
As to claim 16, the limitations that the ratio of H'/R' is between 1.0 to 2.0, and the ratio of D'/G' is between 0.1 to 10.0, is not supported by the specification as originally filed in the same embodiment that has the ratio of R’ to D’ between 0.7 and 0.9, as required by claim 13. The specification recites that these ranges of H'/R' and D'/G' are in an embodiment when the ratio of R’/D’ ranges from 0.4 to 1.0 (par. [0064]). The embodiments are presented as alternates.
As to claim 22, the limitations that the ratio of H/R is between 1.3 to 1.9, and the ratio of D/G is between 1.0 to 2.0, is not supported by the specification as originally filed in the same embodiment that has the ratio of R to D between 0.7 and 0.9, as required by claim 20. The specification recites that these ranges of H/R and D/G are in an embodiment when the ratio of R/D ranges from 0.6 to 1.0 (par. [0064]). The embodiments are presented as alternates.
As to claim 23, the limitations that the ratio of H/R is between 1.0 to 2.0, and the ratio of D/G is between 0.1 to 10.0, is not supported by the specification as originally filed in the same embodiment that has the ratio of R to D between 0.7 and 0.9, as required by claim 20. The specification recites that these ranges of H/R and D/G are in an embodiment when the ratio of R/D ranges from 0.4 to 1.0 (par. [0064]). The embodiments are presented as alternates.
As to claim 25, the limitations that the ratio of H/R is between 1.0 to 8.0, and the ratio of D/G is between 0.1 to 10.0, is not supported by the specification as originally filed in the same embodiment that has the ratio of R to D between 0.7 and 0.9, as required by claim 20. The specification recites that these ranges of H/R and D/G are in an embodiment when the ratio of R/D ranges from 0.4 to 1.0 (par. [0065]). The embodiments are presented as alternates.
As to claims 28 and 29, the limitation that the rod has a constant cross-sectional width viewed from the top of the rod is not supported by the specification as originally filed. The specification does not recite that the rod has a constant cross-sectional width, and since at least part of the rod is covered by the hand grip and therefore obscured in the drawings, it cannot be deduced from the drawings that the rod has a constant cross-sectional width.
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6-9, and 30 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by WIPO International Publication No. WO 2021/126326 to Strohkirch et al. (hereinafter, “Strohkirch”), and in the alternative, under 35 U.S.C. 103 as being unpatentable over Strohkirch.
As to claim 1, Strohkirch discloses a drill guide device (par. [0203]-[0205]), FIGS. 40-41, comprising: a handle extending along a longitudinal handle axis (h), the handle having a top and a bottom, the handle comprising: a rod (4262 including ball and post extending from the ball) extending along the longitudinal handle axis (h) (where the longitudinal handle axis is the axis through the rod, along which at least part of the handle including the rod extends), the rod having a top and a bottom, FIG. 41, the rod having an outer dimension R (width at the post of 4262 as shown in annotated figure) as viewed from the top of the handle, FIG. 40; and a hand grip (4210) extending along the longitudinal handle axis (h) (at least part of the hand grip extends along the longitudinal handle axis) and at least partially surrounding the rod (hand grip 4210 includes socket 4260 which at least partially surrounds 4262) (par. [0205]), the hand grip having a first end portion (portion or area of 4210 near 4260) along the longitudinal handle axis (h), a second end portion opposite the first end portion, the hand grip having an outer dimension H (width as shown in annotated figure) at the first end portion (at some point along the first end portion) as viewed from the top of the handle, FIG. 40; and a drill guide (4230 and 4240) extending along a longitudinal drill guide axis (d) and forming a hollow channel (4242) configured and adapted to receive a drill bit (par. [0203]-[0206]), FIG. 41, the drill guide having an outer dimension D (outer dimension/diameter of portion 4240) as viewed from the top of the handle, the drill guide comprising: a proximal end having an opening to the hollow channel; a distal end having an opening to the hollow channel; wherein the drill guide is coupled to the rod at an angle, FIG. 41; wherein there is a gap having a dimension G between an end of the first end portion and the drill guide measured along the bottom of the rod (see annotated figure); wherein the outer dimension R of the rod is measured proximate the drill guide; and wherein the ratio of R to D is between 0.3 to 0.7 (see annotated figure; R is approximately ½ of D so that the ratio of R to D is about 0.5); and wherein the rod (4262 including ball and post extending from the ball) is at least partially covered by the hand grip (at socket 4260 of hand grip 4210), FIG. 41.
As to claim 6, Strohkirch discloses the drill guide device of claim 1, the ratio of H/R is between 1.5 to 1.7 (about 1.6, as shown in the annotated figure), and the ratio of D/G is between 1.5 to 2.5 (about 2.0, as shown in the annotated figure).
As to claim 7, Strohkirch discloses the drill guide device of claim 1, the ratio of H/R is between 1.3 to 1.9 (about 1.6, as shown in the annotated figure), and the ratio of D/G is between 1.0 to 5.0 (about 2.0, as shown in the annotated figure).
As to claim 8, Strohkirch discloses the drill guide device of claim 1, the ratio of H/R is between 1.0 to 2.0 (about 1.6, as shown in the annotated figure), and the ratio of D/G is between 0.1 to 10.0 (about 2.0, as shown in the annotated figure).
As to claim 9, Strohkirch discloses the drill guide device of claim 1, wherein the ratio of R/D is about 0.5; the ratio of H/R is about 1.6; the ratio of D/G is about 2.0.
As to claim 30, Strohkirch discloses the drill guide device of claim 1, wherein the rod is cylindrical (at post of 4262) and the rod is welded to the drill guide. The claimed phrase “the rod is welded to the drill guide” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found (the rod in Strohkirch is fixedly/integrally attached to the drill guide), a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
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Strohkirch, partial FIGS. 40 and 41, annotated
As to claims 1 and 9, although the annotated figure shows that R is approximately ½ of D, assuming arguendo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the ratio of R/D about 0.5, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the annotated figure, the ratio appears to be about 0.5. With R/D about 0.5, this meets the claimed limitations between 0.3 to 0.7, and about 0.5.
As to claims 1 and 6-9, although the annotated figure shows that the ratio of H/R is about 1.6 (H/R is about 3/2 which is about 1.6, plus or minus 10 percent), assuming arguendo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the ratio of H/R about 1.6, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the annotated figure, the ratio appears to be about 1.6. Additionally, H can be measured at some point along the first end portion in order to meet this ratio. With H/R about 1.6, this meets the claimed limitations between 1.5 to 1.7, between 1.3 to 1.9, and between 1.0 to 2.0, and about 1.6.
As to claims 1 and 6-9, although the annotated figure shows that the ratio of D/G is about 2.0 (D appears about double G), assuming arguendo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the ratio of D/G about 2.0, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the annotated figure, the ratio appears to be about 2.0. Additionally, G can be measured when the ball 4262 is partially received in the socket 4260 of the first end portion of the hand grip, when G may be slightly greater than as shown in FIG. 41. With D/G about 2.0, this meets the claimed limitations between 1.5 to 2.5, between 1.0 to 5.0, between 0.1 to 10.0, and about 2.0.
As to claim 30, assuming arguendo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the rod and the drill guide separate parts that are connected together, since constructing a formerly integral structure in various elements involves only routine skill in the art. Constructing the rod and the drill guide as separate parts that are then connected together would provide modularity to the device, increasing ease of manufacture since cylindrical stock parts can be used for the rod and the drill guide, and different sizes can be connected together based on the application or particular patient. Then, as above, the claimed phrase “the rod is welded to the drill guide” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found (the rod in Strohkirch is a separate part that is attached to the drill guide), a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Claims 1, 11, 13-16, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 6,283,969 to Grusin et al. (hereinafter, “Grusin”) in view of U.S. Patent Application Publication No. US 2020/0170655 to Zakhary et al. (hereinafter, “Zakhary”) and U.S. Patent No. US 10,881,436 to Muller et al. (hereinafter, “Muller”).
As to claim 1, Grusin discloses a drill guide device, FIGS. 62-64, comprising: a handle extending along a longitudinal handle axis (h) (axis from top to bottom of FIG. 63), the handle having a top and a bottom, the handle comprising: a rod (narrow portion between wider hand grip and circular drill guide, in line with the wider hand grip) extending along the longitudinal handle axis (h), the rod having a top and a bottom, the rod having an outer dimension R as viewed from the top of the handle (in FIG. 62, from left to right across the narrow portion); and a hand grip (enlarged wider middle portion) extending along the longitudinal handle axis (h), the hand grip having a first end portion (superior end portion in FIGS. 62-64) along the longitudinal handle axis (h), a second end portion (inferior end portion) opposite the first end portion, the hand grip having an outer dimension H (width as measured at some point along the first end portion) at the first end portion as viewed from the top of the handle; and a drill guide (circular distal end portion at superior end up to the curve in FIG. 63) extending along a longitudinal drill guide axis (d) (through 131), FIG. 63, and forming a hollow channel configured and adapted to receive a drill bit (col. 9 / lines 43-51), FIG. 67, the drill guide having an outer dimension D (width/diameter across circular distal end portion, FIG. 62) as viewed from the top of the handle, the drill guide comprising: a proximal end having an opening to the hollow channel (openings to the hollow channel that receives 131), FIG. 67; a distal end having an opening to the hollow channel, FIG. 67; wherein the drill guide is coupled to the rod at an angle, FIG. 63; wherein there is a gap having a dimension G between an end of the first end portion and the drill guide measured along the bottom of the rod, FIG. 63; wherein the outer dimension R of the rod is measured proximate the drill guide.
As to claim 11, Grusin discloses the drill guide device of claim 1, wherein the angle between the longitudinal handle axis (h) and the longitudinal drill guide axis (d) is an obtuse angle, FIG. 63.
As to claim 13, Grusin discloses the drill guide device of claim 1, further comprising: a second drill guide (circular distal end portion at inferior end up to the curve in FIG. 63) extending along a longitudinal drill guide axis (d) (through 131), FIG. 63, and forming a hollow channel configured and adapted to receive a drill bit (col. 9 / lines 43-51), FIG. 67, the second drill guide having an outer dimension D’ (width/diameter across circular distal end portion at inferior end, FIG. 62) as viewed from the top of the handle, the second drill guide comprising: a proximal end having an opening to the respective hollow channel; a distal end having an opening to the respective hollow channel; wherein the second drill guide is coupled to the rod at an angle and at an opposite end of the rod than the drill guide, FIG. 63; wherein the hand grip has an outer dimension H’ (width as measured at some point along the second end portion) at the second end portion; wherein an outer dimension R’ (in FIG. 62, from left to right across the inferior narrow portion) of the rod is measured proximate the second drill guide; wherein there is a second gap having a dimension G’ between an end of the second end portion and the second drill guide measured along the bottom of the rod, FIG. 63.
As to claim 14, Grusin discloses the ratio of H’/R’ is between 1.5 to 1.7 (about 1.6, as shown in the annotated figure that shows H and R, where H is approximately equal to H’ and R is approximately equal to R’; H and H’ can be measured at some point along the respective end portion in order to meet this ratio), and the ratio of D’/G’ is between 1.2 to 1.3 (about 1.25, as shown in the annotated figure, where D is approximately equal to D’ and G is approximately equal to G’).
As to claim 15, Grusin discloses the drill guide device of claim 13, wherein the ratio of H’/R’ is between 1.3 to 1.9 (about 1.6, as shown in the annotated figure that shows H and R, where H is approximately equal to H’ and R is approximately equal to R’; H and H’ can be measured at some point along the respective end portion in order to meet this ratio), and the ratio of D’/G’ is between 1.0 to 2.0 (about 1.25, as shown in the annotated figure, where D is approximately equal to D’ and G is approximately equal to G’).
As to claim 16, Grusin discloses the drill guide device of clam 13, wherein the ratio of H’/R’ is between 1.0 to 2.0 (about 1.6, as shown in the annotated figure that shows H and R, where H is approximately equal to H’ and R is approximately equal to R’; H and H’ can be measured at some point along the respective end portion in order to meet this ratio), and the ratio of D’/G’ is between 0.1 to 10.0 (about 1.25, as shown in the annotated figure, where D is approximately equal to D’ and G is approximately equal to G’).
As to claim 28, Grusin discloses the drill guide device of claim 1, wherein the rod has a constant cross-sectional width viewed from the top of the rod, FIG. 62.
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Grusin, partial FIGS. 62 and 63, annotated
Grusin is silent as to the hand grip at least partially surrounding the rod; wherein the rod is at least partially covered by the hand grip.
Zakhary teaches that a hand grip can be overmolded onto a rod (par. [0062]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to overmold Grusin’s hand grip onto the rod, so that the hand grip at least partially surrounds the rod and the rod is at least partially covered by the hand grip where the hand grip is overmolded/overlaps, since constructing a formerly integral structure in various elements involves only routine skill in the art, and providing the hand grip as an overmold can allow it to have better ergonomic features and shape and to be made of a different material than the rod, for example one with better hand feel for better grip.
Grusin is silent as to wherein the ratio of R to D is between 0.3 to 0.7 (claim 1); wherein the ratio of R’ to D’ is between 0.7 and 0.9 (claim 13).
Muller teaches a drill guide device (200), FIG. 5, comprising: a handle comprising a rod (narrow portion between wider hand grip and circular drill guide) having an outer dimension R as viewed from a top of the handle; and a hand grip (wider portion of 210) having an outer dimension H; and a drill guide (circular distal end portion) forming a hollow channel configured to receive a drill bit (col. 6 / lines 34-49), the drill guide having an outer dimension D as viewed from the top; wherein the drill guide is coupled to the rod at an angle; wherein the ratio of R to D is about 0.7.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to decrease the outer dimension R or R’ of the rod in Grusin relative to the outer dimension D or D’ of the adjacent drill guide, as taught by Muller, to reduce the weight and material cost of the device, and to allow greater visibility around the rod and the device, while still allowing the drill guide to properly guide a drill.
Although Muller shows that the ratios of R to D and R’ to D’ are about 0.7, assuming arguendo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the ratios of R/D and R’/D’ 0.7, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the figures, the ratio appears to be about 0.7. Allowing for manufacturing tolerances, this ratio may be a miniscule amount less than 0.7 or greater than 0.7, which would be between 0.3 to 0.7 or between 0.7 and 0.9.
As to claims 14-16, although the annotated figure shows that the ratio of H’/R’ (labelled as H and R, since ends of the drill guide device have the same dimensions) is about 1.6 (H’/R’ is about 3/2 which is about 1.6, plus or minus 10 percent), assuming arguendo, it would have been obvious to make the ratio of H’/R’ about 1.6, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the annotated figure, the ratio appears to be about 1.6. Additionally, H’ can be measured at some point along the first end portion in order to meet this ratio. With H’/R’ about 1.6, this meets the claimed limitations of between 1.5 to 1.7, between 1.3 to 1.9, and between 1.0 to 2.0.
Assuming arguendo, as to claims 14-16, it would have been obvious to make the ratio of D’/G’ about 1.25, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the annotated figure, the ratio appears to be about 1.25. With D’/G’ about 1.25, this meets the claimed limitations of between 1.2 to 1.3, between 1.0 to 2.0, and between 0.1 to 10.0.
Claims 20-25 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Grusin in view of Zakhary, Muller, and U.S. Patent No. US 7,883,513 to Ralph et al. (hereinafter, “Ralph”).
As to claim 20, Grusin discloses a drill guide device, FIGS. 62-64, comprising: a handle extending along a longitudinal handle axis (h) (axis from top to bottom of FIG. 63), the handle having a top and a bottom, the handle comprising: a rod (narrow portion between wider hand grip and circular drill guide, in line with the wider hand grip) extending along the longitudinal handle axis (h), the rod having a top and a bottom, the rod having an outer dimension R as viewed from the top of the handle (in FIG. 62, from left to right across the narrow portion); and a hand grip (enlarged wider middle portion) extending along the longitudinal handle axis (h), the hand grip having a first end portion (superior end portion in FIGS. 62-64) along the longitudinal handle axis (h), a second end portion (inferior end portion) opposite the first end portion, the hand grip having an outer dimension H (width as measured at some point along the first end portion) at the first end portion as viewed from the top of the handle; and a drill guide (circular distal end portion at superior end up to the curve in FIG. 63) extending along a longitudinal drill guide axis (d) (through 131), FIG. 63, and forming a hollow channel configured and adapted to receive a drill bit (col. 9 / lines 43-51), FIG. 67, the drill guide having an outer dimension D (width/diameter across circular distal end portion, FIG. 62) as viewed from the top of the handle, the drill guide comprising: a proximal end having an opening to the hollow channel (openings to the hollow channel that receives 131), FIG. 67; a distal end having an opening to the hollow channel, FIG. 67; wherein the drill guide is coupled to the rod at an angle, FIG. 63; wherein there is a gap having a dimension G between an end of the first end portion and the drill guide measured along the bottom of the rod, FIG. 63; wherein the outer dimension R of the rod is measured proximate the drill guide; wherein the rod is welded to the drill guide. The claimed phrase “the rod is welded to the drill guide” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found (the rod in Grusin is fixedly/integrally attached to the drill guide), a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claim 21, Grusin discloses the drill guide device of claim 20, the ratio of H/R is between 1.5 to 1.7 (about 1.6, as shown in the annotated figure; H can be measured at some point along the respective end portion in order to meet this ratio), and the ratio of D/G is between 1.2 to 1.3 (about 1.25, as shown in the annotated figure).
As to claim 22, Grusin discloses the drill guide device of claim 20, the ratio of H/R is between 1.3 to 1.9 (about 1.6, as shown in the annotated figure; H can be measured at some point along the respective end portion in order to meet this ratio), and the ratio of D/G is between 1.0 to 2.0 (about 1.25, as shown in the annotated figure).
As to claim 23, Grusin discloses the drill guide device of claim 20, the ratio of H/R is between 1.0 to 2.0 (about 1.6, as shown in the annotated figure; H can be measured at some point along the respective end portion in order to meet this ratio), and the ratio of D/G is between 0.1 to 10.0 (about 1.25, as shown in the annotated figure).
As to claim 24, Grusin discloses the drill guide device of claim 20, wherein the ratio of H/R is about 1.6 (about 1.6, as shown in the annotated figure; H can be measured at some point along the respective end portion in order to meet this ratio); the ratio of D/G is about 1.25 (about 1.25, as shown in the annotated figure).
As to claim 25, Grusin discloses the drill guide device of claim 20, the ratio of H/R is between 1.0 to 8.0 (about 1.6, as shown in the annotated figure; H can be measured at some point along the respective end portion in order to meet this ratio), and the ratio of D/G is between 0.1 to 10.0 (about 1.25, as shown in the annotated figure).
As to claim 29, Grusin discloses the rod has a constant cross-sectional width viewed from the top of the rod, FIG. 62.
Assuming arguendo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the rod and the drill guide separate parts that are connected together, since constructing a formerly integral structure in various elements involves only routine skill in the art. Constructing the rod and the drill guide as separate parts that are then connected together would provide modularity to the device, increasing ease of manufacture since cylindrical stock parts can be used for the rod and the drill guide, and different sizes can be connected together based on the application or particular patient. Then, as above, the claimed phrase “the rod is welded to the drill guide” is being treated as a product by process limitation. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found (the rod in Grusin is a separate part that is attached to the drill guide), a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
Grusin is silent as to the hand grip at least partially surrounding the rod; wherein the rod is at least partially covered by the hand grip (claim 20).
Zakhary teaches that a hand grip can be overmolded onto a rod (par. [0062]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to overmold Grusin’s hand grip onto the rod, so that the hand grip at least partially surrounds the rod and the rod is at least partially covered by the hand grip where the hand grip is overmolded/overlaps, since constructing a formerly integral structure in various elements involves only routine skill in the art, and providing the hand grip as an overmold can allow it to have better ergonomic features and shape and to be made of a different material than the rod, for example one with better hand feel for better grip.
Grusin is silent as to wherein the ratio of R to D is between 0.7 and 0.9 or about 0.8.
Muller teaches a drill guide device (200), FIG. 5, comprising: a handle comprising a rod (narrow portion between wider hand grip and circular drill guide) having an outer dimension R as viewed from a top of the handle; and a hand grip (wider portion of 210) having an outer dimension H; and a drill guide (circular distal end portion) forming a hollow channel configured to receive a drill bit (col. 6 / lines 34-49), the drill guide having an outer dimension D as viewed from the top; wherein the drill guide is coupled to the rod at an angle; wherein the ratio of R to D is between 0.7 and 0.9.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to decrease the outer dimension R of the rod in Grusin relative to the outer dimension D of the adjacent drill guide, as taught by Muller, to reduce the weight and material cost of the device, and to allow greater visibility around the rod and the device, while still allowing the drill guide to properly guide a drill.
Although Muller shows that the ratio of R to D is about 0.8 (plus or minus 20% to allow for manufacturing tolerances), assuming arguendo, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the ratio of R/D 0.8, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the figures, the ratio appears to be about 0.8, which also meets the claimed limitation of between 0.7 and 0.9.
As to claims 21-25, although the annotated figure shows that the ratio of H/R is about 1.6 (H/R is about 3/2 which is about 1.6, plus or minus 10 percent), assuming arguendo, it would have been obvious to make the ratio of H/R about 1.6, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the annotated figure, the ratio appears to be about 1.6. Additionally, H can be measured at some point along the first end portion in order to meet this ratio. With H/R about 1.6, this meets the claimed limitations of between 1.5 to 1.7, between 1.3 to 1.9, between 1.0 to 2.0, about 1.6, and between 1.0 to 8.0.
Assuming arguendo, as to claims 21-25, it would have been obvious to make the ratio of D/G about 1.25, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. As shown in the annotated figure, the ratio appears to be about 1.25. With D/G about 1.25, this meets the claimed limitations of between 1.2 to 1.3, between 1.0 to 2.0, between 0.1 to 10.0, about 1.25, and between 0.1 to 10.0.
Grusin is silent as to the rod is cylindrical.
Ralph teaches a drill guide device, FIG. 1a, comprising a handle (108) comprising a rod and a hand grip; and a drill guide (100) coupled to the rod at an angle; where the rod is cylindrical (col. 9 / lines 46-48).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the rod in Grusin cylindrical, as taught by Ralph, since this is one of numerous shapes or configurations a person having ordinary skill in the art would find obvious for the purpose of providing an elongated rod connecting a hand grip to a drill guide. A cylindrical rod would facilitate manufacture from a cylindrical blank, and the lack of sharp edges would prevent catching on and damage of tissue. The relative dimensions as required by Grusin/Muller would remain the same, with a width/diameter from the top view of the rod providing the outer dimension R.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Grusin in view of Zakhary, Muller, and Ralph (hereinafter, “Grusin/Zakhary/Muller/Ralph”), as applied to claims 20-25 and 29 above, and further in view of U.S. Patent No. US 9,345,514 to Robinson et al. (hereinafter, “Robinson”).
Grusin/Zakhary/Muller/Ralph are silent as to wherein the dimension G is 4 mm.
Robinson teaches that a drill for a bone can have a 2.8 mm diameter (col. 7 / lines 27-29).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a drill with a 2.8 mm diameter as taught in Robinson to drill a hole in the bone as required by Grusin/Zakhary/Muller/Ralph, since Robinson teaches that this diameter is appropriate as a bone drill. The hollow channel through Grusin’s drill guide would be sized to receive this drill, thereby having an internal diameter of about 2.8 mm. Grusin contemplates providing various drill guide insert tips to accommodate different size tools therethrough (Grusin, col. 9 / lines 49-51). Then, since the dimension G of the gap appears to be about 40% greater than the diameter of the hollow channel in Grusin, the dimension G would be about 4 mm. Even if the dimension G is slightly smaller or greater than 40% of the diameter of the hollow channel, it would have been obvious to make G 4 mm, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The dimension G can also be adjusted based on the interpretation of the extent of the drill guide and the hand grip.
Conclusion
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775