Detailed Action
This is the first office action on the merits for US application number 18/900,135.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cylindrical opening of claims 9 and 17 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 1, 16, and 20 is/are objected to because of the following informalities:
Claim 1 line 1 should read “A surgical drill sheath[[,]] comprising:”.
Claim 16 line 1 should read “An adjustable navigated surgical drill sheath[[,]] comprising:”.
Claim 16 line 13 should read “sheath insert having a plurality of locking features [[and]] configured to be moved up and down within the hollow region”.
Claim 20 lines 5-10 should read “remov[[e]]ing an existing drill sheath insert from the main body of the surgical drill sheath; selecting the drill sheath insert to be placed into the main body based on the chosen pedicle screw diameter; contacting a drill head of the pedicle drill against a top of the drill sheath insert adjusted within the main body; and actuat[[e]]ing the pedicle drill.”
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “an adjustment arrangement” in claim 1 line 7, “a plurality of locking features” in claim 6 line 2, “a latching mechanism” in claim 6 line 3, “manual release feature” in claim 8 line 3, “an adjustment arrangement” in claim 16 line 8, “a plurality of locking features” in claim 16 lines 12-13, and “a latching mechanism” in claim 16 lines 13-14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim(s) 1 recites/recite the limitation "the maximum distance that the separate surgical drill bit can extend " in line 9. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “to [[the]]a maximum distance that the separate surgical drill bit can extend”.
Claim(s) 2, 3, 5, and 6 recites/recite the limitation "the adjustment mechanism" in claim 2 line 1, claim 3, line 1, claim 5 line 1, and claim 6 lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the adjustment arrangement” in claim 2 line 1, claim 3, line 1, claim 5 line 1, and claim 6 lines 2-3”.
Claim(s) 8 is/are unclear with regards to “a manual release feature” in line 3 and the intended scope or equivalents thereof. Examiner is interpreting this as referring to a surface of pivoting member 130 and suggests amending to clarify.
Claim(s) 9 recites/recite the limitation “the diameter of the separate surgical drill bit" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a diameter of the separate surgical drill bit”.
Claim(s) 16 recites/recite the limitation "the maximum distance that the separate surgical drill bit can extend " in line 10. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “to [[the]]a maximum distance that the separate surgical drill bit can extend”.
Claim(s) 16 recites/recite the limitation "the adjustment mechanism" in line 12. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “the adjustment arrangement”.
Claim(s) 17 recites/recite the limitation “the diameter of the separate surgical drill bit" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “[[the]]a diameter of the separate surgical drill bit”.
Claim(s) 19 recites/recite the limitation "the maximum distance that a separate surgical drill bit " in lines 5-6. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “that reflects [[the]]a maximum distance that the separate surgical drill bit”.
Claim(s) 4, 7, 10-15, 18, and 20 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-11, 13, 14, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keyer et al. (US 2005/0119663, hereinafter “Keyer”).
As to claim 1, Keyer discloses a surgical drill sheath (Figs. 11 and 2-7, ¶42 discloses Fig. 11 provides an alternate locking member) comprising: a handle (12) capable of allowing an operator to hold the surgical drill sheath (Fig. 11, ¶26); a main body (14, 34, Fig. 11) coupled to the handle (Fig. 11), the main body having a top region (upper portion as shown in Fig. 11, Fig. 11), a bottom region (lower portion as shown in Fig. 11, Fig. 11), and a hollow region (14, Figs. 11, 3, and 6) between the top and bottom regions (Fig. 11), wherein the main body is capable of receiving a separate surgical drill bit (Fig. 13) through a top opening (opening at 24 as shown in Fig. 6 and with dashed lines in Fig. 3, Figs. 6 and 3) in the top region (Fig. 6), through the hollow region (Fig. 11, 3, and 6), and through a bottom opening (opening at 22 shown with dashed lines in Fig. 3, Fig. 3) in the bottom region (Figs. 13, 11, and 6, ¶s 26, 27, and 45); and an adjustment arrangement (16, 20, 23, 21, 46, 52, Figs. 11 and 6, ¶42 discloses Fig. 11 provides an alternate locking member) capable of facilitating setting a specific drill depth for the separate surgical drill bit received through the main body (Figs. 11 and 6, ¶s 26, 27, 42, and 45), the specific drill depth corresponding to a maximum distance that the separate surgical drill bit can extend past the bottom opening (Figs. 11 and 6, ¶s 27, 34, 35, 37, 42, and 45), wherein the adjustment arrangement allows for a plurality of different specific drill depths (Figs. 11 and 6, ¶s 27, 34, 35, 37, 42, and 45, where ¶37 discloses that adjacent detents 44 may be dimensioned and configured to provide depth adjustment from 10 mm to 50 mm in 2 mm increments).
As to claim 2, Keyer discloses that the adjustment arrangement includes a mechanical hard stop (upper-right facing surface of 16 portion 24 as shown in Fig. 11, Fig. 11) proximate the top region (as defined, Fig. 11), the mechanical hard stop being capable of abutting against a bottom surface of a separate surgical drill operating the separate surgical drill bit when the specific drill depth is reached (Figs. 11 and 6, ¶45 discloses that the drill bit is inserted into the first and second drill guide bodies 14, 16 until the fixed stop or other feature engages or contacts proximal end 24).
As to claim 3, Keyer discloses that the adjustment arrangement is capable of facilitating adjusting a distance between the mechanical hard stop and the bottom opening (Figs. 11 and 6, ¶s 26, 27, 42, and 45).
As to claim 4, Keyer discloses that the separate surgical drill that the mechanical hard stop is capable of abutting against the bottom surface of is a pedicle drill (Figs. 11 and 6, ¶s 45 and 2, ¶45 discloses use on a vertebra and that the drill bit is inserted into the first and second drill guide bodies 14, 16 until the fixed stop or other feature engages or contacts proximal end 24, ¶2 discloses that this applies to the pedicle).
As to claim 5, Keyer discloses that the adjustment arrangement includes a movable drill sheath insert (as defined, i.e. 16, Figs. 11 and 4-6) located within the hollow region (Figs. 11 and 6) and capable of being moved up and down within the hollow region to facilitate setting the specific drill depth (Figs. 11 and 6, ¶s 26, 27, 42, and 45).
As to claim 6, Keyer discloses that the movable drill sheath insert includes a plurality of locking features (44s) along an outer surface thereof (Figs. 4-6), and wherein the adjustment arrangement further includes a latching mechanism (20, 23, 21, 46, 52, Figs. 11 and 6, ¶42 discloses Fig. 11 provides an alternate locking member) capable of interacting with the plurality of locking features (Fig. 6, ¶s 37, 41, and 42) capable of locking the movable drill sheath insert at a specific locked position relative to the main body to facilitate setting the specific drill depth (Fig. 6, ¶s 26, 27, 34, 35, 37, 42, and 45).
As to claim 7, Keyer discloses that the latching mechanism includes a pivoting member (20, 46, Fig. 11) having a pawl (46) that engages with the plurality of locking features (Fig. 6)capable of locking the movable drill sheath insert at the specific locked position (Figs. 11 and 6, ¶s 37 and 45).
As to claim 8, Keyer discloses that the pivoting member is spring loaded (via spring biased plunger 23 of ¶42, Fig. 11, ¶42) capable of locking the movable drill sheath insert at a specific locked position (Fig. 11, ¶42), and wherein the pivoting member further includes a manual release feature (upper-right surface as shown in Fig. 11, Fig. 11) capable of overcoming the spring loaded locked position and allowing the movable drill sheath insert to be moved (when a user presses thereon, ¶s 42 and 45).
As to claim 9, Keyer discloses that the movable drill sheath insert includes a cylindrical opening (inner diameter D5 of ¶31, Figs. 4 and 6, ¶31) therethrough (Fig. 4) capable of accepting the separate surgical drill bit therethrough (¶31) and having a diameter that corresponds to a diameter of the separate surgical drill bit (Figs. 4 and 13, ¶31).
As to claim 10, Keyer discloses that the movable drill sheath insert is capable of being removed from the main body (Figs. 3-6).
As to claim 11, Keyer discloses that the surgical drill sheath is capable of receiving an alternative movable drill sheath insert within the main body when the movable drill sheath insert is removed (in as much as Applicant’s if one so chooses to do so, Figs. 3-6, as evidenced by Greenberg et al. US 5,743,916 Figs. 4A and 12A and col. 6 lines 30-33), and wherein the movable drill sheath insert and alternative movable drill sheath insert that surgical drill sheath is capable of receiving are capable of use with differently dimensioned separate surgical drill bits (in as much as Applicant’s if one so chooses to do so, Figs. 3-6, as evidenced by Greenberg et al. US 5,743,916 Figs. 4A and 12A and col. 6 lines 30-33).
As to claim 13, Keyer discloses that the plurality of different specific drill depths range from about 8 to 35 mm (¶s 35 and 37 disclose that adjacent detents 44 may be dimensioned and configured to provide depth adjustment from 10 mm to 50 mm in 2 mm increments).
As to claim 14, Keyer discloses that the plurality of different specific drill depths can be adjusted by increments of about 2 mm (¶s 35 and 37 disclose that adjacent detents 44 may be dimensioned and configured to provide depth adjustment from 10 mm to 50 mm in 2 mm increments).
As to claim 19, Keyer discloses that a method (¶45) of using a surgical drill sheath (Figs. 11 and 2-7, ¶42 discloses Fig. 11 provides an alternate locking member), the method comprising: placing a drill sheath insert (16, Figs. 11 and 4-6) into a main body of the surgical drill sheath (14, 34, Fig. 11), the main body having a top region (upper portion as shown in Fig. 11, Fig. 11), a bottom region (lower portion as shown in Fig. 11, Fig. 11), and a hollow region (14, Figs. 11, 3, and 6) between the top and bottom regions (Fig. 11); adjusting the drill sheath insert to a correct height within the main body (Figs. 11 and 6, ¶s 26, 27, 37, 42, and 45, where ¶37 discloses that adjacent detents 44 may be dimensioned and configured to provide depth adjustment from 10 mm to 50 mm in 2 mm increments), wherein the correct height corresponds to a specific drill depth (Figs. 11 and 6, ¶s 27, 34, 35, 37, 42, and 45) that reflects a maximum distance that a separate surgical drill bit operated by a separate surgical drill can extend past a bottom opening (opening at 22 shown with dashed lines in Fig. 3, Fig. 3) in the bottom region of the main body (Figs. 11 and 6, ¶s 27, 34, 35, 37, 42, and 45); and guiding a separate surgical drill bit (“drill bit” of ¶45, ¶45) through the drill sheath insert and the main body of the surgical drill sheath (¶45) such that the surgical drill bit extends through the entire drill sheath insert as well as through a top opening (opening at 24 as shown in Fig. 6 and with dashed lines in Fig. 3, Figs. 6 and 3) in the top region (Fig. 6), through the hollow region (Fig. 6), and through the bottom opening in the bottom region of the main body (Figs. 13, 11, and 6, ¶s 26, 27, and 45).
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 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keyer in view of Capote et al. (US 2019/0298392, hereinafter “Capote”).
As to claim 12, Keyer discloses the invention of claim 1 as well as that the background for the invention is for drilling pilot holes for pedicle screws (¶2).
Keyer is silent to the diameter of the sheath.
Capote teaches a surgical drill (12, 14, Fig. 1), probe (Fig. 10, ¶45), drill bit (16, Figs. 1 and 11), and an enlarging/reamer bit (150, Fig. 12, ¶47) for drilling pilot holes for pedicle screws (80, Figs. 10-15), wherein the cutting head (50) of the drill bit is smaller than the diameter of a pedicle screw (80, ¶47) and bone canals produced by the cutting head can be in the range of approximately 1.5 mm to 2.5 mm (¶47) and can be widened by the enlarging/reamer bit which have diameters in the range of about 2.0 mm to 3.0 mm (¶47), wherein the cutting head can be sized to have a diameter approximating that of a threaded shaft (94) of the pedicle screw such as approximately 2.0 mm up to the largest diameter fastener used in spinal procedures, e.g. 3.0 mm (¶47).
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specifically configure the surgical drill sheath of Keyer to be configured for use with separate surgical drill bits having diameters of about 2, 2.5, or 3 mm, since such a modification would have involved a mere specification of the size of a component in order to achieve an appropriate size for drilling pilot holes for pedicle screws (Capote Figs. 10-15, ¶47; Keyer ¶2). A change in size is generally recognized as being within the level of ordinary skill in the art.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keyer in view of Kostrzewski et al. (US 2015/0305817).
As to claim 15, Keyer discloses the invention of claim 1.
Keyer is silent to a plurality of fiducial markers coupled to the main body, wherein the plurality of fiducial markers are configured to facilitate use of the surgical drill sheath as a navigated device in an augmented reality environment.
Kostrzewski teaches a surgical drill sheath (202/302/402, Figs. 1-4) for performing an operation such as preparing holes in vertebrae (¶58), the sheath comprising: a handle (208) capable of allowing an operator to hold the surgical drill sheath (Fig. 2, ¶58); a main body (204, 206, portion between 206 and 208 as shown in Fig. 2, Figs. 2 and 3A) coupled to the handle (Fig. 2), the main body having a top region (right portion as shown in Fig. 2, Fig. 2), a bottom region (left portion as shown in Fig. 2, Fig. 2), and a hollow region (204, 206) between the top and bottom regions (as defined, Fig. 2), wherein the main body is capable of receiving a separate surgical drill bit (212a, 212b, Fig. 2, ¶58) through a top opening in the top region (upper opening as shown in Fig. 4, Fig. 4, ¶58), through the hollow region (Fig. 4, ¶58), and through a bottom opening in the bottom region (lower opening as shown in Fig. 4, Fig. 4, ¶58) and a plurality of fiducial markers (shown on 210 in Fig. 2, Fig. 2) coupled to the main body (Fig. 2), wherein the plurality of fiducial markers are capable of facilitating use of the surgical drill sheath as a navigated device in an augmented reality environment (Figs. 1-4, ¶58).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the sheath as disclosed by Keyer by adding the fiducial markers as taught by Kostrzewski in order to track the sheath during an operation such as preparing holes in vertebrae (Kostrzewski ¶58) or drilling pilot holes for pedicle screws (Keyer ¶2).
As to claims 16 and 17, Keyer discloses an adjustable navigated surgical drill sheath (Figs. 11 and 2-7, ¶42 discloses Fig. 11 provides an alternate locking member) comprising: a handle (12) capable of allowing an operator to hold the surgical drill sheath (Fig. 11, ¶26); a main body (14, 34, Fig. 11) coupled to the handle (Fig. 11), the main body having a top region (upper portion as shown in Fig. 11, Fig. 11), a bottom region (lower portion as shown in Fig. 11, Fig. 11), and a hollow region (14, Figs. 11, 3, and 6) between the top and bottom regions (Fig. 11), wherein the main body is capable of receiving a separate surgical drill bit (Fig. 13) through a top opening (opening at 24 as shown in Fig. 6 and with dashed lines in Fig. 3, Figs. 6 and 3) in the top region (Fig. 6), through the hollow region (Fig. 11, 3, and 6), and through a bottom opening (opening at 22 shown with dashed lines in Fig. 3, Fig. 3) in the bottom region (Figs. 13, 11, and 6, ¶s 26, 27, and 45); and an adjustment arrangement (16, 20, 23, 21, 46, 52, Figs. 11 and 6, ¶42 discloses Fig. 11 provides an alternate locking member) capable of facilitating setting a specific drill depth for the separate surgical drill bit received through the main body (Figs. 11 and 6, ¶s 26, 27, 42, and 45), the specific drill depth corresponding to a maximum distance that the separate surgical drill bit can extend past the bottom opening (Figs. 11 and 6, ¶s 27, 34, 35, 37, 42, and 45), the adjustment arrangement allows for a plurality of different specific drill depths (Figs. 11 and 6, ¶s 27, 34, 35, 37, 42, and 45, where ¶37 discloses that adjacent detents 44 may be dimensioned and configured to provide depth adjustment from 10 mm to 50 mm in 2 mm increments), wherein the adjustment arrangement includes a removable drill sheath insert (as defined, i.e. 16, Figs. 11 and 3-6) having a plurality of locking features (44s) capable of moving up and down within the hollow region (Figs. 11 and 4-6, ¶s 26, 27, 36, 37, 42, and 45) and a latching mechanism (20, 23, 21, 46, 52, Figs. 11 and 6, ¶42 discloses Fig. 11 provides an alternate locking member) having a spring loaded pivoting member (20, 46, via spring biased plunger 23 of ¶42, Fig. 11, ¶42) with a pawl (46) capable of interacting with the plurality of locking features (Fig. 6) capable of locking the removable drill sheath insert at a specific locked position relative to the main body to facilitate setting the specific drill depth (Figs. 11 and 6, ¶s 26, 27, 34, 35, 37, 42, and 45). As to claim 17, Keyer discloses that the removable drill sheath insert includes a cylindrical opening (inner diameter D5 of ¶31, Figs. 4 and 6, ¶31) therethrough (Fig. 4) having a diameter that corresponds to a diameter of the separate surgical drill bit (Figs. 4 and 13, ¶31). capable of accepting the separate surgical drill bit therethrough (¶31) and wherein the removable drill sheath insert is capable of being be replaced with an alternative removable drill sheath insert having a cylindrical opening of a different diameter that corresponds to a separate alternative surgical drill bit diameter (in as much as Applicant’s if one so chooses to do so, Figs. 3-6, as evidenced by Greenberg et al. US 5,743,916 Figs. 4A and 12A and col. 6 lines 30-33).
Keyer is silent to a plurality of fiducial markers coupled to the main body, wherein the plurality of fiducial markers are configured to facilitate use of the surgical drill sheath as a navigated device in an augmented reality environment.
Kostrzewski teaches a surgical drill sheath (202/302/402, Figs. 1-4) for performing an operation such as preparing holes in vertebrae (¶58), the sheath comprising: a handle (208) capable of allowing an operator to hold the surgical drill sheath (Fig. 2, ¶58); a main body (204, 206, portion between 206 and 208 as shown in Fig. 2, Figs. 2 and 3A) coupled to the handle (Fig. 2), the main body having a top region (right portion as shown in Fig. 2, Fig. 2), a bottom region (left portion as shown in Fig. 2, Fig. 2), and a hollow region (204, 206) between the top and bottom regions (as defined, Fig. 2), wherein the main body is capable of receiving a separate surgical drill bit (212a, 212b, Fig. 2, ¶58) through a top opening in the top region (upper opening as shown in Fig. 4, Fig. 4, ¶58), through the hollow region (Fig. 4, ¶58), and through a bottom opening in the bottom region (lower opening as shown in Fig. 4, Fig. 4, ¶58) and a plurality of fiducial markers (shown on 210 in Fig. 2, Fig. 2) coupled to the main body (Fig. 2), wherein the plurality of fiducial markers are capable of facilitating use of the surgical drill sheath as a navigated device in an augmented reality environment (Figs. 1-4, ¶58).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the sheath as disclosed by Keyer by adding the fiducial markers as taught by Kostrzewski in order to track the sheath during an operation such as preparing holes in vertebrae (Kostrzewski ¶58) or drilling pilot holes for pedicle screws (Keyer ¶2).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keyer in view of Kostrzewski in view of Capote.
As to claim 17, the combination of Keyer in view of Kostrzewski discloses the invention of claim 16 as well as that the plurality of different specific drill depths range from about 8 to 35 mm (¶s 35 and 37 disclose that adjacent detents 44 may be dimensioned and configured to provide depth adjustment from 10 mm to 50 mm in 2 mm increments), and wherein the plurality of different specific drill depths can be adjusted by increments of about 2 mm (¶s 35 and 37 disclose that adjacent detents 44 may be dimensioned and configured to provide depth adjustment from 10 mm to 50 mm in 2 mm increments).
The combination of Keyer in view of Kostrzewski is silent to the diameter of the sheath.
Capote teaches a surgical drill (12, 14, Fig. 1), probe (Fig. 10, ¶45), drill bit (16, Figs. 1 and 11), and an enlarging/reamer bit (150, Fig. 12, ¶47) for drilling pilot holes for pedicle screws (80, Figs. 10-15), wherein the cutting head (50) of the drill bit is smaller than the diameter of a pedicle screw (80, ¶47) and bone canals produced by the cutting head can be in the range of approximately 1.5 mm to 2.5 mm (¶47) and can be widened by the enlarging/reamer bit which have diameters in the range of about 2.0 mm to 3.0 mm (¶47), wherein the cutting head can be sized to have a diameter approximating that of a threaded shaft (94) of the pedicle screw such as approximately 2.0 mm up to the largest diameter fastener used in spinal procedures, e.g. 3.0 mm (¶47).
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specifically configure the surgical drill sheath of the combination of Keyer in view of Kostrzewski to be configured for use with separate surgical drill bits having diameters of about 2, 2.5, or 3 mm, since such a modification would have involved a mere specification of the size of a component in order to achieve an appropriate size for drilling pilot holes for pedicle screws (Capote Figs. 10-15, ¶47; Keyer ¶2). A change in size is generally recognized as being within the level of ordinary skill in the art.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Keyer in view of Capote and Greenberg et al. (US 5,743,916, hereinafter “Greenberg”).
As to claim 20, Keyer discloses the invention of claim 19 as well as that the background for the invention is for drilling pilot holes for pedicle screws (¶2) and a mechanical hard stop (upper-right facing surface of 16 portion 24 as shown in Fig. 11, Fig. 11) proximate the top region (as defined, Fig. 11), the mechanical hard stop being capable of abutting against a bottom surface of a separate surgical drill operating the separate surgical drill bit when the specific drill depth is reached (Figs. 11 and 6, ¶45 discloses that the drill bit is inserted into the first and second drill guide bodies 14, 16 until the fixed stop or other feature engages or contacts proximal end 24).
Keyer is silent to the separate surgical drill is a pedicle drill and further comprising the steps of: choosing a desired length and diameter for one or more pedicle screws to be used in a subsequent pedicle operation; removing an existing drill sheath insert from the main body of the surgical drill sheath; selecting the drill sheath insert to be placed into the main body based on the chosen pedicle screw diameter; contacting a drill head of the pedicle drill against a top of the drill sheath insert adjusted within the main body; and actuating the pedicle drill.
Capote teaches a similar method (Figs. 10-15) of inserting a pedicle screw (80, Figs. 10-15) into a vertebra (Figs. 10-15), the method comprising: choosing a desired length and diameter for one or more pedicle screws to be used in a subsequent pedicle operation (Fig. 15); providing a surgical drill (12, 14, Fig. 1), probe (Fig. 10, ¶45), drill bit (16, Figs. 1 and 11), and an enlarging/reamer bit (150, Fig. 12, ¶47) for drilling pilot holes for pedicle screws (80, Figs. 10-15), wherein the cutting head (50) of the drill bit is smaller than the diameter of a pedicle screw (80, ¶47) and bone canals produced by the cutting head can be in the range of approximately 1.5 mm to 2.5 mm (¶47) and can be widened by the enlarging/reamer bit which have diameters in the range of about 2.0 mm to 3.0 mm (¶47), wherein the cutting head can be sized to have a diameter approximating that of a threaded shaft (94) of the pedicle screw such as approximately 2.0 mm up to the largest diameter fastener used in spinal procedures, e.g. 3.0 mm (¶47), and actuating the pedicle drill (¶s 29 and 39).
Greenberg teaches a similar method (Fig. 12A) of using a surgical drill sheath (900), the method comprising: placing a drill sheath insert (910, 960) into a main body (915) of the surgical drill sheath (915, 925, Fig. 12A), the drill sheath insert comprising and adapter portion (960); the main body having a top region (upper portion as shown in Fig. 12A, Fig. 12A), a bottom region (lower portion as shown in Fig. 12A, Fig. 12A), and a hollow region (915) between the top and bottom regions (Fig. 12A); adjusting the drill sheath insert to a correct height within the main body (col. 9 line 66 – col. 10 line 16, col. 14 lines 32-38), wherein the correct height corresponds to a specific drill depth that reflects a maximum distance that a separate surgical drill bit operated by a separate surgical drill can extend past a bottom opening in the bottom region of the main body (Fig. 12A); and guiding a separate surgical drill bit (170, shown in Fig. 4A for an alternate sheath, col. 8 lines 4-6) through the drill sheath insert and the main body of the surgical drill sheath such that the surgical drill bit extends through the entire drill sheath insert as well as through a top opening in the top region, through the hollow region, and through the bottom opening in the bottom region of the main body (to drill bone as disclosed in col. 8 lines 4-6, as shown in Figs. 4A and 28 for an alternate sheath, col. 8 lines 4-6); selecting the drill sheath insert (col. 14 lines 20-23, col. 15 lines 6-10), removing an existing drill sheath insert from the main body of the surgical drill sheath (portion 960/160, col. 15 lines 10-15); selecting the drill sheath insert (col. 15 lines 10-15 and 20-25) to be placed into the main body based on a chosen screw diameter (col. 3 lines 20-25, col. 15 lines 20-25); contacting a drill head of a drill against a top of the drill sheath insert adjusted within the main body (col. 14 lines 52-61); and actuating the drill (col. 14 lines 52-61).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/specify the method as disclosed by Keyer comprises choosing an appropriately sized pedicle screw, using the pedicle drill, and actuating the pedicle drill as taught by Capote in order to implant a pedicle screw in a pedicle of a vertebra (Capote abstract) including drilling pilot holes for pedicle screws (Capote Figs. 10-15, ¶47; Keyer ¶2). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the insert as disclosed by Keyer to be multiple inserts with varying diameters as taught by Greenberg in order to adapt the diameter to drill a hole for a guidewire (Greenberg col. 15 lines 6-10) as well as a hole large enough for a surgical screw (Greenberg col. 15 lines 10-22) and finally to aid in placing a surgical screw (Greenberg col. 15 lines 22-30).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to the step of abutting a feature against the mechanical hard stop of the combination of Keyer and Capote to specifically include contacting the drill head on the top of the mechanical hard stop as taught by Greenberg in order to drill pilot holes for pedicle screws (Greenberg col. 15 line 10-25; Capote Figs. 10-15, ¶47; Keyer ¶2) to a maximum penetration depth of the drill bit (Greenberg col 15 lines 15-20 and 31-35; Keyer ¶45) based on a precise length of selected screw (Greenberg col. 15 lines 31-35).
Conclusion
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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