Detailed Action
This is the final office action for US application number 18/950,103. Claims are evaluated as filed on May 26, 2026.
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 .
Response to Arguments
Applicant's arguments filed May 26, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Bess, Elsawah, and Elliott teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that every feature is shown in the drawings as driver (100), a distal end (inherent feature), a proximal end (inherent feature), an outer shaft (120) with threaded portion (122), inner shaft (110) comprising a drive tip (111) and a sleeve (140) and similar for claims 8 and 15 (Remarks p. 9), Examiner notes that while having a distal end and a proximal end of a structure is an inherent feature, the current claims are written to claim a distal end (unshown feature) + a proximal end (unshown feature) + an outer shaft (120) with threaded portion (122) + inner shaft (110) comprising a drive tip (111) + a sleeve (140). That is, there are simply no structures shown in addition to the claimed an outer shaft (120) with threaded portion (122) + inner shaft (110) comprising a drive tip (111) + a sleeve (140) that appear to be able to be reasonably construed to represent the additionally claimed a distal end (unshown feature) + a proximal end (unshown feature).
With regards to Applicant’s argument that the previously cited Elliott and Elsawah do not discloses the newly claimed features (Remarks p. 9-11), Examiner notes that the rejections below have been amended accordingly.
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 driver having/comprising a distal end, a proximal end, an outer shaft with a threaded portion, an inner shaft comprising a drive tip, and a sleeve in claim 1 lines 8-18, the driver having/comprising a distal end, a proximal end, a sleeve, an outer shaft with a threaded portion, an inner shaft comprising a tip, and an array in claim 8 lines 3-16, and the driver having/comprising a distal end, a proximal end, an outer shaft with a threaded portion, an inner shaft comprising a drive tip, and a sleeve in claim 15 lines 8-14, 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, 8, 9, and 16 is/are objected to because of the following informalities:
Claim 1 line 23 should read “the inside diameter of the sleeve is less than the second outside diameter of the screw head diameter”.
Claim 8 line 18 should read “the first outside diameter of the sleeve”.
Claim 9 line 6 should read “the first outside diameter of the sleeve is greater”.
Claim 9 line 8 should read “the inside diameter of the sleeve is less”.
Claim 16 line 6 should read “the inside diameter of the sleeve is less”.
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: “drive feature” in claim 1 line 6 and “drive feature” in claim 15 line 5.
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) 1-21 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 is/are unclear with regards to “a driver having a first distal end configured to engage the surgical screw and a first proximal end opposite the first distal end, the driver comprising: an outer shaft… with a threaded portion…, an inner shaft comprising …a drive tip…., and a sleeve” in lines 8-18 relative to the disclosed device. That is, as disclosed in paragraph 130, the proximal end comprises diameter 114 and portion 115 of the inner shaft 110 and diameter 128 and portion 123 of outer shaft 120. The disclosure does not specifically identify the intended distal end other than being configured to engage screw 190. Thus, it appears that the disclosed distal end and proximal end are not in addition to the outer shaft, threaded portion, inner shaft, drive tip, and sleeve as claimed, but are instead portions/regions of the outer shaft, inner shaft, and sleeve. In other words, there does not appear to be support for both the claimed “a first distal end configured to engage the surgical screw” of line 8 and “an outer shaft comprising a second distal end with a threaded portion configured to engage the inside thread” of lines 12-13 and “an inner shaft comprising a third distal end with a drive tip configured to engage the drive feature” of lines 15-16, and “the sleeve is further configured to receive the first arm and the second arm” of line 25 or the claim is unclear as to what disclosed structure the first distal end refers; wherein a similar analysis for the claimed proximal end appears to lead to the same conclusion. Examiner notes that this could be claimed as each component (outer shaft, inner shaft, and sleeve) comprising a distal end and a proximal end, which is the most commonly taken approach that Examiner sees used by Applicant and therefore appears to be the most intuitive. Alternatively, this could be claimed as a distal end comprising a distal outer shaft portion, a distal inner shaft portion, and a distal sleeve portion and a proximal end comprising a proximal outer shaft portion, a proximal inner shaft portion, and a proximal sleeve portion. Thus, Examiner is interpreting this as referring to, and suggests amending as, “a driver
Claim(s) 8 is/are unclear with regards to “a driver having a first distal end configured to engage the surgical screw and a first proximal end opposite the first distal end, the driver comprising: a sleeve…an outer shaft… with a threaded portion…, an inner shaft …., and an array” in lines 3-14 relative to the disclosed device. That is, as disclosed in paragraph 130, the proximal end comprises diameter 114 and portion 115 of the inner shaft 110 and diameter 128 and portion 123 of outer shaft 120. The disclosure does not specifically identify the intended distal end other than being configured to engage screw 190. Thus, it appears that the disclosed distal end and proximal end are not in addition to the sleeve, outer shaft, threaded portion, inner shaft, and array as claimed, but are instead portions/regions of the sleeve, outer shaft, and inner shaft. In other words, there does not appear to be support for both the claimed “a first distal end configured to engage the surgical screw” of line 3 and “an outer shaft …comprising a second distal end with a threaded portion configured to threadably engage the surgical screw” of lines 9-11 and “an inner shaft …comprising a tip” of lines 12-16; wherein a similar analysis for the claimed proximal end appears to lead to the same conclusion. Examiner notes that this could be claimed as each component (outer shaft, inner shaft, and sleeve) comprising a distal end and a proximal end, which is the most commonly taken approach that Examiner sees used by Applicant and therefore appears to be the most intuitive. Alternatively, this could be claimed as a distal end comprising a distal outer shaft portion, a distal inner shaft portion, and a distal sleeve portion and a proximal end comprising a proximal outer shaft portion, a proximal inner shaft portion, and a proximal sleeve portion. Thus, Examiner is interpreting this as referring to, and suggests amending as, “a driver
Claim(s) 15 is/are unclear with regards to “a driver having a first distal end configured to engage the surgical screw and a first proximal end opposite the first distal end, the driver comprising: …an outer shaft… with a threaded portion…, an inner shaft comprising a drive tip…., and a sleeve” in lines 8-14 relative to the disclosed device. That is, as disclosed in paragraph 130, the proximal end comprises diameter 114 and portion 115 of the inner shaft 110 and diameter 128 and portion 123 of outer shaft 120. The disclosure does not specifically identify the intended distal end other than being configured to engage screw 190. Thus, it appears that the disclosed distal end and proximal end are not in addition to the outer shaft, threaded portion, inner shaft, and sleeve as claimed, but are instead portions/regions of the outer shaft, and inner shaft, sleeve. In other words, there does not appear to be support for both the claimed “a first distal end configured to engage the surgical screw” of line 8 and “an outer shaft comprising a second distal end with a threaded portion configured to engage the inside thread” of lines 10-11 and “an inner shaft comprising a drive tip” of line 13; wherein a similar analysis for the claimed proximal end appears to lead to the same conclusion. Examiner notes that this could be claimed as each component (outer shaft, inner shaft, and sleeve) comprising a distal end and a proximal end, which is the most commonly taken approach that Examiner sees used by Applicant and therefore appears to be the most intuitive. Alternatively, this could be claimed as a distal end comprising a distal outer shaft portion, a distal inner shaft portion, and a distal sleeve portion and a proximal end comprising a proximal outer shaft portion, a proximal inner shaft portion, and a proximal sleeve portion. Thus, Examiner is interpreting this as referring to, and suggests amending as, “a driver
Claim(s) 2-7, 9-14, and 16-21 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 § 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) 1-16 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bess et al. (US 2015/028255, hereinafter “Bess”) in view of Elsawah et al. (US 2023/0141374, hereinafter “Elsawah”).
As to claims 1-3 and 5-7, Bess discloses a surgical system (10, 800, Figs. 1-15) comprising: a surgical screw (800, Figs. 13-15) comprising: a screw head (820) comprising a second outside diameter (Figs. 13-13C), a first arm (portion of 820 to the left of slot 821 as shown in Fig. 13A, Fig. 13A), a second arm (portion of 820 to the right of slot 821 as shown in Fig. 13A, Fig. 13A), and an inside thread (822); and a screw body (810, 830) coupled with the screw head (Figs. 13-15) and comprising a drive feature (811, Fig, 13C, ¶80) and a threaded portion (830, Figs. 13-13B, ¶80) capable of engaging a bone (Figs. 13-15, ¶80); and a driver (10, Figs. 1-12, 14, and 15) comprising: an outer shaft (110, Figs. 4-5C, 7A-10B, and 13) comprising a second distal end (right end of 110 as shown in Figs. 7A and 7B, Figs. 7A and 7B, ¶56) with a threaded portion (111, Figs. 7A and 7B, ¶56) capable of engaging the inside thread (Fig. 13, ¶56) and a second proximal end (left end of 110 as shown in Figs. 5A, 5C, 7B-7C, 8B, 8C, 9B, 9C, and 10B, Figs. 5A, 5C, 7B-7C, 8B, 8C, 9B, 9C, 10B, and 13B, ¶56) opposite the second distal end of the outer shaft (as defined); an inner shaft (400) comprising a third distal end (408, 410, 411, 412, Figs. 2, 3, 10B, and 13) with a drive tip (412, Figs. 2, 3, 10B, and 13, ¶54) capable of engaging the drive feature (Fig. 13, ¶54) and a shaft tip (408, Figs. 2, 3, 10B, and 13) capable of coupling to the third distal end of the inner shaft (via unspecified structure in through hole 409a as best shown in Fig. 10B as the left portion of the drive tip nested within the right portion of 408 and the throughhole 409a withing the nested portion, Figs. 2, 3, 10B, and 13, ¶53) so that the inner shaft is captive within the outer shaft (when secured to the handle as shown in Fig. 13, Fig. 13, ¶53 discloses that flange 410 acts as a stop when 400 is advanced through 100 when 410 abuts the distal end of 100, i.e. as shown in Fig. 10B); and a sleeve (20) capable being received within an end effector of a robotic assisted surgical device (due to the structure shown in Figs. 1 and 2 if one so chooses to do so, Figs. 1 and 2), the sleeve comprising a first outside diameter (Figs. 1, 2, 10B, 11, and 13-15) and an inside diameter (Figs. 1, 2, 10B, 11, and 13); wherein: the first outside diameter of the sleeve is greater than or equal to the second outside diameter of the screw head diameter (Fig. 13); the inside diameter of the sleeve is less than the second outside diameter of the screw head diameter (Fig. 13). As to claim 2, Bess discloses that the first outside diameter of the sleeve is capable of providing a bearing surface shaped to contact the end effector (due to the structure shown in Figs. 1 and 2 if one so chooses to do so, Figs. 1 and 2). As to claim 3, Bess discloses a thumb wheel (200, 300) capable of being removably received on the second proximal end of the outer shaft (Figs. 1, 2, 4-10B, and 13C-15) so that rotation of the thumb wheel results in rotation of the outer shaft (due to mating hexagonal cross-sections of 200 and 110 disclosed in ¶s 56 and 57), wherein the outer shaft is capable of rotating independently of the sleeve (when the sleeve is secured with a hand of the clinician as disclosed in ¶82, Fig. 13, ¶82) capable of facilitating threaded engagement and threaded disengagement of the surgical screw (¶56). As to claim 5, Bess discloses a handle (401) capable of being engaged with the inner shaft (Fig. 3) so that rotation of the handle results in rotation of the inner shaft (Fig. 3). As to claim 7, Bess discloses that the inner shaft is capable of rotating independently of the outer shaft and the sleeve (when 100 is decoupled from 400 as disclosed in ¶82, ¶82).
Bess is silent to the sleeve is further configured to receive the first arm and the second arm. As to claim 6, Bess is silent to the sleeve further comprises a third arm and a fourth arm, wherein the third arm and the fourth arm are configured to be received between the first arm and the second arm.
Elsawah teaches a similar surgical system (Figs. 1-26, abstract) comprising: a surgical screw (102, Figs. 1, 2, 15, 16, 13-15, 19, 20, and 23) comprising: a screw head (114, Fig. 19) comprising a second outside diameter (Fig. 19), a first arm (left portion of 114 as shown in Fig. 20, Fig. 20), a second arm (right portion of 114 as shown in Fig. 20, Fig. 20), and an inside thread (1602, Figs. 15 and 16, ¶111); and a screw body (112, Fig. 19) coupled with the screw head (Fig. 16) and comprising a drive feature (1604, Fig. 16, ¶111) and a threaded portion (threaded shaft of 112, Fig. 16, ¶111) capable of engaging a bone (¶90); and a driver (100, Figs. 1-26, ¶90) comprising: an outer shaft (108, Figs. 2-4, 12A-16, and 21-23, ¶108) comprising a second distal end (left portion of 108 as shown in Fig. 2, Fig. 2) with a threaded portion (304/1204, Figs. 3, 4, and 12A-15, ¶92) capable of engaging the inside thread (Fig. 16, ¶s 11 and 108) and a second proximal end (1218, Figs. 12A-14) opposite the second distal end of the outer shaft (as defined, Figs. 12A-14); an inner shaft (104, Figs. 5A-6) comprising a third distal end (left portion of 104 as shown in Figs. 5A-6, Figs. 5A-6) with a drive tip (302, Figs. 5A-6) capable of engaging the drive feature (Fig. 16, ¶96) and a proximal end (502, Figs. 5A-6) opposite the distal end of the inner shaft (as defined, Figs. 5A-6); and a sleeve (110, Figs. 17A-18) comprising a proximal end (portion of 1101 between 1706s and 1704s, Figs. 17A-18) capable of being received within an end effector (due to the structure shown in Figs. 17A-18 such is capable of being received in an appropriately sized opening) of a robotic assisted surgical device (if one so chooses to insert therein) and a distal end (1704s, 17A-18) opposite the proximal distal end of the sleeve (as defined, 17A-18), the sleeve comprising a first outside diameter (Fig. 19) and an inside diameter (Figs. 16 and 18), wherein: the first outside diameter of the sleeve is greater than or equal to the second outside diameter of the screw head (Fig. 19; wherein at least the outer diameter of 1706 is shown to be greater than the outer diameter of 114 in Fig. 19); the inside diameter of the sleeve is less than the second outside diameter of the screw head (Fig. 16); and the sleeve is further capable of receiving the first arm and the second arm (between 1704s, Figs. 16 and 19); wherein the sleeve comprises a third arm (left 1704 as shown in Fig. 17A, Figs. 17A-20) and a fourth arm (right 1704 as shown in Fig. 17A, Figs. 17A-20) capable of being received between the first arm and the second arm (Fig. 19, ¶113). As to claim 3, Elsawah teaches a thumb wheel (1206, ¶108) capable of being engaged with the outer shaft (Figs. 12A-14) so that rotation of the thumb wheel results in rotation of the outer shaft (¶108), wherein the outer shaft is capable of rotating independently of the sleeve (in as much as Applicant’s ¶117) capable of facilitating threaded engagement and threaded disengagement of the surgical screw (¶s 108 and 111). As to claim 5, Elsawah teaches a handle (106, 1100) capable of being engaged with the inner shaft (¶105) so that rotation of the handle results in rotation of the inner shaft (¶105). As to claim 6, Elsawah teaches that the sleeve further comprises a third arm (left 1704 as shown in Fig. 17A, Figs. 17A-20) and a fourth arm (right 1704 as shown in Fig. 17A, Figs. 17A-20), wherein the third arm and the fourth arm are capable of being received between the first arm and the second arm (Fig. 19, ¶113). As to claim 7, Elsawah teaches that the inner shaft is capable of rotating independently of the outer shaft and the sleeve (Fig. 16, ¶s 114 and 117).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the sleeve as disclosed by Bess by adding the third and fourth arms as taught by Elsawah in order to extend the sleeve into the U-shaped recesses formed by the first and second arms (Elsawah ¶113) so that the sleeve can be utilized to provide counter-torque when driving a screw (Elsawah ¶113).
As to claim 4, the combination of Bess and Elsawah discloses the invention of claim 3.
The combination of Bess and Elsawah is silent to an array configured to facilitate relative motion tracking of the surgical system, wherein the array is configured to be received on the second proximal end of the outer shaft and secured to the outer shaft.
Elsawah further teaches an array (2510, Figs. 25 and 26) capable of facilitating relative motion tracking of the surgical system (¶122), wherein the array is capable of being secured to the second proximal end of the outer shaft (via 106/2502 and 104/2504, Fig. 25, ¶122).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device as disclosed by the combination of Bess and Elsawah by adding an array as taught by Elsawah in order to enable a surgical navigation system to track the three-dimensional position of the surgical navigation array in order to track the three-dimensional position of the device (Elsawah ¶122) to allow surgically navigated implantation of the surgical screw with all of the accompanying advantages in precision and accuracy of placement associated therewith (Elsawah ¶122).
As to claims 8, 9, 11, and 12, Bess discloses a surgical system (10, 800, Figs. 1-15) capable of use for placement of a surgical screw (800, Figs. 13-15) into a bone (Figs. 13-15, ¶80), the surgical system comprising: a driver (10, Figs. 1-12, 14, and 15) comprising: and a sleeve (20) capable being received within an end effector of a robotic assisted surgical device (due to the structure shown in Figs. 1 and 2 if one so chooses to do so, Figs. 1 and 2), the sleeve comprising a first outside diameter (Figs. 1, 2, 10B, 11, and 13-15) and an inside diameter (Figs. 1, 2, 10B, 11, and 13); an outer shaft (110, Figs. 4-5C, 7A-10B, and 13) capable of being received in the sleeve (Figs. 10B and 13) and comprising a second distal end (right end of 110 as shown in Figs. 7A and 7B, Figs. 7A and 7B, ¶56) with a threaded portion (111, Figs. 7A and 7B, ¶56) capable of threadably engage the surgical screw (Fig. 13, ¶56) and a second proximal end (left end of 110 as shown in Figs. 5A, 5C, 7B-7C, 8B, 8C, 9B, 9C, and 10B, Figs. 5A, 5C, 7B-7C, 8B, 8C, 9B, 9C, 10B, and 13B, ¶56) opposite the second distal end of the outer shaft (as defined); an inner shaft (400) comprising a third distal end (408, 410, 411, 412, Figs. 2, 3, 10B, and 13) and capable of being received in the outer shaft (Figs. 10B and 13, ¶51) and rotatable independently of the outer shaft and the sleeve (when the 100 is decoupled from 400 as disclosed in ¶82, Fig. 13, ¶82); wherein: the inner shaft comprises a tip (412, Figs. 2, 3, 10B, and 13, ¶54) capable of coupling to the third distal end of the inner shaft (via unspecified structure in through hole 409a as best shown in Fig. 10B as the left portion of the drive tip nested within the right portion of 408 and the throughhole 409a withing the nested portion, Figs. 2, 3, 10B, and 13, ¶53) so that the inner shaft is captive within the outer shaft (when secured to the handle as shown in Fig. 13, Fig. 13, ¶53 discloses that flange 410 acts as a stop when 400 is advanced through 100 when 410 abuts the distal end of 100, i.e. as shown in Fig. 10B); and the first outside diameter of the sleeve is capable of providing a bearing surface (Fig. 2) capable of being received in the end effector (due to the structure shown in Figs. 1 and 2 if one so chooses to do so, Figs. 1 and 2). As to claim 9, Bess discloses comprising the surgical screw (800, Figs. 13-15), the surgical screw comprising: a screw head (820) comprising a second outside diameter (Figs. 13-13C); and a screw body (810, 830) coupled with the screw head (Figs. 13-15) and capable of engaging the bone (Figs. 13-15, ¶80); wherein: the first outside diameter of the sleeve is greater than or equal to the second outside diameter of the screw head diameter (Fig. 13); and the inside diameter of the sleeve is less than the second outside diameter of the screw head diameter (Fig. 13). As to claim 11, Bess discloses a thumb wheel (200, 300) capable of being engaged with the outer shaft (Figs. 1, 2, 4-10B, and 13C-15) so that rotation of the thumb wheel results in rotation of the outer shaft (due to mating hexagonal cross-sections of 200 and 110 disclosed in ¶s 56 and 57), wherein the outer shaft is capable of rotating independently of the sleeve (when the sleeve is secured with a hand of the clinician as disclosed in ¶82, Fig. 13, ¶82) capable of facilitating threaded engagement and threaded disengagement of the surgical screw (¶56). As to claim 11, Bess discloses a handle (401) capable of being engaged with the inner shaft (Fig. 3) so that rotation of the handle results in rotation of the inner shaft (Fig. 3).
Bess is silent to an array configured to facilitate relative motion tracking of the surgical system, wherein the array is configured to be received on the second proximal end of the outer shaft.
Elsawah teaches a similar surgical system (Figs. 1-26, abstract) capable of use for placement of a surgical screw (102, Figs. 1, 2, 15, 16, 13-15, 19, 20, and 23) into a bone (¶90), the surgical system comprising: a driver (100, Figs. 1-26, ¶90) comprising: a sleeve (110, Figs. 17A-18) capable of being received within an end effector (due to the structure shown in Figs. 17A-18 such is capable of being received in an appropriately sized opening) of a robotic assisted surgical device (if one so chooses to insert therein), the sleeve comprising a first outside diameter (Fig. 19) and an inside diameter (Figs. 16 and 18), an outer shaft (108, Figs. 2-4, 12A-16, and 21-23, ¶108) capable of being received in the sleeve (Fig. 2 and 16) and comprising a second distal end (left portion of 108 as shown in Fig. 2, Fig. 2) with a threaded portion (304/1204, Figs. 3, 4, and 12A-15, ¶92) capable of threadably engaging the surgical screw (Fig. 16, ¶s 11 and 108) and a second proximal end (1218, Figs. 12A-14) opposite the second distal end of the outer shaft (as defined, Figs. 12A-14); an inner shaft (104, Figs. 5A-6) comprising a third distal end (left portion of 104 as shown in Figs. 5A-6, Figs. 5A-6) capable of being received in the outer shaft (Fig. 2 and 16) and rotating independently of the outer shaft and the sleeve (Fig. 16, ¶s 9, 82, 114, and 117); and an array (2510, Figs. 25 and 26) capable of facilitating relative motion tracking of the surgical system (¶122), wherein: the inner shaft comprises a tip (302, Figs. 5A-6) capable of being coupled to the third distal end of the inner shaft (Figs. 5A-6); the outside diameter of the sleeve is capable of providing a bearing surface (Figs. 17A-18) capable of being received in the end effector (due to the structure shown in Figs. 17A-18 such is capable of being received in an appropriately sized opening if one so chooses to insert such therein); and the array is capable of being received on the second proximal end of the outer shaft (via 106/2502 and 104/2504, Fig. 25, ¶122). As to claim 9, Elsawah teaches further comprising the surgical screw (102, Figs. 1, 2, 15, 16, 13-15, 19, 20, and 23), the surgical screw comprising: a screw head (114, Fig. 19) comprising a second outside diameter (Fig. 19); and a screw body (112, Fig. 19) coupled with the screw head (Fig. 16) and capable of engaging a bone (¶90); wherein: the first outside diameter of the sleeve is greater than or equal to the second outside diameter of the screw head (Fig. 19; wherein at least the outer diameter of 1706 is shown to be greater than the outer diameter of 114 in Fig. 19); and the inside diameter of the sleeve is less than the second outside diameter of the screw head (Fig. 16). As to claim 11, Elsawah teaches a thumb wheel (1206, ¶108) capable of being engaged with the outer shaft (Figs. 12A-14) so that rotation of the thumb wheel results in rotation of the outer shaft (¶108), wherein the outer shaft is capable of rotating independently of the sleeve (in as much as Applicant’s ¶117) capable of facilitating threaded engagement and threaded disengagement of the surgical screw (¶s 108 and 111). As to claim 12, Elsawah teaches a handle (106, 1100) capable of being engaged with the inner shaft (¶105) so that rotation of the handle results in rotation of the inner shaft (¶105).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device as disclosed by Bess by adding an array as taught by Elsawah in order to enable a surgical navigation system to track the three-dimensional position of the surgical navigation array in order to track the three-dimensional position of the device (Elsawah ¶122) to allow surgically navigated implantation of the surgical screw with all of the accompanying advantages in precision and accuracy of placement associated therewith (Elsawah ¶122).
As to claim 10, the combination of Bess and Elsawah discloses that the screw head further comprises a first arm (portion of 820 to the left of slot 821 as shown in Fig. 13A, Fig. 13A), a second arm (portion of 820 to the right of slot 821 as shown in Fig. 13A, Fig. 13A), and an inside thread (822).
The combination of Bess and Elsawah is silent to the sleeve is further configured to receive the first arm and the second arm.
Elsawah further teaches that the screw head further comprises a first arm (left portion of 114 as shown in Fig. 20, Fig. 20), a second arm (right portion of 114 as shown in Fig. 20, Fig. 20), and an inside thread (1602, Figs. 15 and 16, ¶111) and the sleeve is capable of receiving the first arm and the second arm (between 1704s, Figs. 16 and 19); wherein the sleeve comprises a third arm (left 1704 as shown in Fig. 17A, Figs. 17A-20) and a fourth arm (right 1704 as shown in Fig. 17A, Figs. 17A-20) capable of being received between the first arm and the second arm (Fig. 19, ¶113).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the sleeve as disclosed by the combination of Bess and Elsawah by adding the third and fourth arms as taught by Elsawah in order to extend the sleeve into the U-shaped recesses formed by the first and second arms (Elsawah ¶113) so that the sleeve can be utilized to provide counter-torque when driving a screw (Elsawah ¶113).
As to claim 13, the combination of Bess and Elsawah discloses comprising the surgical screw (800, Figs. 13-15), the surgical screw comprising: a screw head (820) comprising a first arm (portion of 820 to the left of slot 821 as shown in Fig. 13A, Fig. 13A), a second arm (portion of 820 to the right of slot 821 as shown in Fig. 13A, Fig. 13A), and an inside thread (822); and a screw body (810, 830) coupled with the screw head (Figs. 13-15) and capable of engaging the bone (Figs. 13-15, ¶80).
The combination of Bess and Elsawah is silent to the sleeve further comprises a third arm and a fourth arm, wherein the third arm and the fourth arm are configured to be received between the first arm and the second arm.
Elsawah further teaches comprising the surgical screw (102, Figs. 1, 2, 15, 16, 13-15, 19, 20, and 23), the surgical screw comprising: a screw head (114, Fig. 19) comprising a first arm (left portion of 114 as shown in Fig. 20, Fig. 20), a second arm (right portion of 114 as shown in Fig. 20, Fig. 20), and an inside thread (1602, Figs. 15 and 16, ¶111) and a screw body (112, Fig. 19) coupled with the screw head (Fig. 16) and capable of engaging the bone (¶90); wherein the sleeve further comprises a third arm (left 1704 as shown in Fig. 17A, Figs. 17A-20) and a fourth arm (right 1704 as shown in Fig. 17A, Figs. 17A-20), wherein the third arm and the fourth arm are capable of being received between the first arm and the second arm (Fig. 19, ¶113).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the sleeve as disclosed by the combination of Bess and Elsawah by adding the third and fourth arms as taught by Elsawah in order to extend the sleeve into the U-shaped recesses formed by the first and second arms (Elsawah ¶113) so that the sleeve can be utilized to provide counter-torque when driving a screw (Elsawah ¶113).
As to claim 14, the combination of Bess and Elsawah discloses the surgical screw comprising a screw head (820) comprising a first arm length (portion of 820 to the left of slot 821 as shown in Fig. 13A, Fig. 13A), a second arm length (portion of 820 to the right of slot 821 as shown in Fig. 13A, Fig. 13A), and an inside thread (822); and a screw body (810, 830) coupled with the screw head (Figs. 13-15) and capable of engaging the bone (Figs. 13-15, ¶80).
The combination of Bess and Elsawah is silent to the sleeve further comprises a third arm length and a fourth arm length, wherein the third arm and the fourth arm are wherein the third arm length is less than or equal to the first arm length.
Elsawah further teaches the surgical screw comprising: a screw head (114, Fig. 19) comprising a first arm length (left portion of 114 as shown in Fig. 20, Fig. 20), a second arm length (right portion of 114 as shown in Fig. 20, Fig. 20), and an inside thread (1602, Figs. 15 and 16, ¶111) and a screw body (112, Fig. 19) coupled with the screw head (Fig. 16) and capable of engaging the bone (¶90); wherein the sleeve further comprises a third arm length (left 1704 as shown in Fig. 17A, Figs. 17A-20) and a fourth arm length (right 1704 as shown in Fig. 17A, Figs. 17A-20), wherein the third arm and the fourth arm are capable of being received between the first arm and the second arm (Fig. 19, ¶113), wherein the third arm and the fourth arm are wherein the third arm length is less than or equal to the first arm length (Fig. 19).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the sleeve as disclosed by the combination of Bess and Elsawah by adding the third and fourth arms as taught by Elsawah in order to extend the sleeve into the U-shaped recesses formed by the first and second arms (Elsawah ¶113) so that the sleeve can be utilized to provide counter-torque when driving a screw (Elsawah ¶113).
As to claims 15, 16, 18, and 19, Bess discloses a surgical system (10, 800, Figs. 1-15) comprising: a surgical screw (800, Figs. 13-15) comprising: a screw head (820) comprising a first arm (portion of 820 to the left of slot 821 as shown in Fig. 13A, Fig. 13A), a second arm (portion of 820 to the right of slot 821 as shown in Fig. 13A, Fig. 13A), and an inside thread (822); and a screw body (810, 830) coupled with the screw head (Figs. 13-15) and comprising a drive feature (811, Fig, 13C, ¶80) and a threaded portion (830, Figs. 13-13B, ¶80) capable of engaging a bone (Figs. 13-15, ¶80); and a driver (10, Figs. 1-12, 14, and 15) comprising: an outer shaft (110, Figs. 4-5C, 7A-10B, and 13) comprising a second distal end (right end of 110 as shown in Figs. 7A and 7B, Figs. 7A and 7B, ¶56) with a threaded portion (111, Figs. 7A and 7B, ¶56) capable of engaging the inside thread (Fig. 13, ¶56) and a second proximal end (left end of 110 as shown in Figs. 5A, 5C, 7B-7C, 8B, 8C, 9B, 9C, and 10B, Figs. 5A, 5C, 7B-7C, 8B, 8C, 9B, 9C, 10B, and 13B, ¶56) opposite the second distal end of the outer shaft (as defined), the outer shaft further comprising a first non-circular drive portion (113, Figs. 2, 4, 5A, 7A, 8A, and 9A, ¶56; where ¶56 discloses 113 as labeled in Fig. 7A as having flats in a hexagonal configuration); an inner shaft (400) comprising a third distal end (408, 410, 411, 412, Figs. 2, 3, 10B, and 13) with a drive tip (412, Figs. 2, 3, 10B, and 13, ¶54) capable of engaging the drive feature (Fig. 13, ¶54); and a sleeve (20) capable being received within an end effector of a robotic assisted surgical device (due to the structure shown in Figs. 1 and 2 if one so chooses to do so, Figs. 1 and 2), and a thumb wheel (200, 300) capable of being slidably received on the second proximal end of the outer shaft (Figs. 1, 2, 4-10B, and 13C-15), the thumb wheel comprising a second non-circular drive portion (201, Figs. 2, 4, and 5C, ¶57; where ¶57 discloses that lumen 201 is hexagonal in cross section) capable of engaging the first non-circular drive portion of the outer shaft (¶57) capable of transferring rotational motion of the thumb wheel to rotational motion of the outer shaft (¶s 56, 57, and 82); wherein: the outer shaft is capable of rotating independently of the sleeve (when the sleeve is secured with a hand of the clinician as disclosed in ¶82, Fig. 13, ¶82) capable of facilitating threaded engagement and threaded disengagement of the surgical screw (¶56). As to claim 16, Bess discloses the screw head comprising a second outside diameter (Figs. 13-13C), wherein the sleeve further comprises a first outside diameter (Figs. 1, 2, 10B, 11, and 13-15) and an inside diameter (Figs. 1, 2, 10B, 11, and 13); the first outside diameter of the sleeve is greater than or equal to the second outside diameter of the screw head diameter (Fig. 13); the inside diameter of the sleeve is less than the second outside diameter of the screw head diameter (Fig. 13). As to claim 18, Bess discloses a handle (401) capable of being engaged with the inner shaft (Fig. 3) so that rotation of the handle results in rotation of the inner shaft (Fig. 3). As to claim 19, Bess discloses that the sleeve further comprises a first outside diameter (Figs. 1, 2, 10B, 11, and 13-15), wherein the first outside diameter of the sleeve is capable of providing a bearing surface shaped to be capable of being received in the end effector (due to the structure shown in Figs. 1 and 2 if one so chooses to do so, Figs. 1 and 2).
Bess is silent to the sleeve comprising a third arm and a fourth arm, wherein the third arm and the fourth arm are configured to be received between the first arm and the second arm. As to claim 16, Bess is silent to the sleeve is further capable of receiving the first arm and the second arm.
Elsawah teaches a similar surgical system (Figs. 1-26, abstract) comprising: a surgical screw (102, Figs. 1, 2, 15, 16, 13-15, 19, 20, and 23) comprising: a screw head (114, Fig. 19) comprising a first arm (left portion of 114 as shown in Fig. 20, Fig. 20), a second arm (right portion of 114 as shown in Fig. 20, Fig. 20), and an inside thread (1602, Figs. 15 and 16, ¶111); and a screw body (112, Fig. 19) coupled with the screw head (Fig. 16) and comprising a drive feature (1604, Fig. 16, ¶111) and a threaded portion (threaded shaft of 112, Fig. 16, ¶111) capable of engaging a bone (¶90); and a driver (100, Figs. 1-26, ¶90) comprising: an outer shaft (108, Figs. 2-4, 12A-16, and 21-23, ¶108) comprising a second distal end (left portion of 108 as shown in Fig. 2, Fig. 2) with a threaded portion (304/1204, Figs. 3, 4, and 12A-15, ¶92) capable of engaging the inside thread (Fig. 16, ¶s 11 and 108) and a second proximal end (1218, Figs. 12A-14) opposite the second distal end of the outer shaft (as defined, Figs. 12A-14); an inner shaft (104, Figs. 5A-6) comprising a third distal end (left portion of 104 as shown in Figs. 5A-6, Figs. 5A-6) with a drive tip (302, Figs. 5A-6) capable of engaging the drive feature (Fig. 16, ¶96); and a sleeve (110, Figs. 17A-18) capable of being received within an end effector (due to the structure shown in Figs. 17A-18 such is capable of being received in an appropriately sized opening) of a robotic assisted surgical device (if one so chooses to insert therein), the sleeve comprising a third arm (left 1704 as shown in Fig. 17A, Figs. 17A-20) and a fourth arm (right 1704 as shown in Fig. 17A, Figs. 17A-20), and a thumb wheel (1206, ¶108) capable of being engaged with the outer shaft (Figs. 12A-14); wherein the outer shaft is capable of rotating independently of the sleeve (Fig. 16, ¶s 95, 114, and 117) capable of facilitating threaded engagement and threaded disengagement of the surgical screw (Fig. 16, ¶s 108, 111, 112, 114, and 117); the third arm and the fourth arm are capable of being received between the first arm and the second arm (between 1704s, Figs. 16 and 19, ¶113). As to claim 16, Elsawah teaches that the screw head further comprises a second outside diameter (Fig. 19), wherein: the sleeve further comprises a first outside diameter (Fig. 19) and an inside diameter (Figs. 16 and 18), the first outside diameter of the sleeve is greater than or equal to the second outside diameter of the screw head (Fig. 19; wherein at least the outer diameter of 1706 is shown to be greater than the outer diameter of 114 in Fig. 19); the inside diameter of the sleeve is less than the second outside diameter of the screw head (Fig. 16); and the sleeve is further capable of receiving the first arm and the second arm (between 1704s, Figs. 16 and 19, ¶113). As to claim 18, Elsawah teaches a handle (106, 1100) capable of being engaged with the inner shaft (¶105) so that rotation of the handle results in rotation of the inner shaft (¶105).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the sleeve as disclosed by Bess by adding the third and fourth arms as taught by Elsawah in order to extend the sleeve into the U-shaped recesses formed by the first and second arms (Elsawah ¶113) so that the sleeve can be utilized to provide counter-torque when driving a screw (Elsawah ¶113).
As to claim 20, the combination of Bess and Elsawah discloses the invention of claim 15.
The combination of Bess and Elsawah is silent to an array configured to facilitate relative motion tracking of the surgical system, wherein the array is configured to be received on the second proximal end of the outer shaft and secured to the outer shaft.
Elsawah further teaches an array (2510, Figs. 25 and 26) capable of facilitating relative motion tracking of the surgical system (¶122), wherein the array is capable of being secured to the second proximal end of the outer shaft (via 106/2502 and 104/2504, Fig. 25, ¶122).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device as disclosed by the combination of Bess and Elsawah by adding an array as taught by Elsawah in order to enable a surgical navigation system to track the three-dimensional position of the surgical navigation array in order to track the three-dimensional position of the device (Elsawah ¶122) to allow surgically navigated implantation of the surgical screw with all of the accompanying advantages in precision and accuracy of placement associated therewith (Elsawah ¶122).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bess and Elsawah in view of Elliott et al. (US 2020/0121396, hereinafter “Elliott”).
As to claim 21, the combination of Bess and Elsawah discloses the invention of claim 15 as well as the second proximal end of the outer shaft further comprises a first retaining groove (115, ¶56); and the surgical system further comprises a spiral retaining ring (¶56) within the first retaining groove of the outer shaft (¶56) capable of removably retaining the thumb wheel on the outer shaft (¶56).
The combination of Bess and Elsawah is silent to the thumb wheel further comprises a second retaining groove; the spiral retaining ring being a canted coil spring seated within the second retaining groove of the thumb wheel and within the first retaining groove of the outer shaft.
Elliott teaches a similar surgical system (Figs. 10-15) capable of use with a surgical screw (¶s 39 and 51), the system comprising: a driver (214) comprising: an outer shaft (212) a first non-circular drive portion (364, Fig. 11, ¶83 discloses a hexagonal cross section); an inner shaft (guide wire of ¶48, ¶48); and a sleeve (246) capable of being received within an end effector of a robotic assisted surgical device (due to the shown structure in Fig. 10, Fig. 10); and a thumb wheel (282) capable of slidingly receiving the outer shaft (Fig. 14, ¶80), the thumb wheel comprising a second non-circular drive portion (292, 294, ¶s 81 and 83 disclose a hexagonal cross section) capable of engaging the first non-circular drive portion of the outer shaft (Fig. 14) capable of transferring rotational motion of the thumb wheel to rotational motion of the outer shaft (due to the hexagonal cross sections disclosed in ¶83, ¶83); wherein the outer shaft further comprises a first retaining groove (360, Figs. 11 and 14, ¶79); the thumb wheel further comprises a second retaining groove (368, Fig. 14, ¶80); and the surgical system further comprises a canted coil spring (366, Figs. 14 and 15, ¶79) seated within the second retaining groove of the thumb wheel and within the first retaining groove of the outer shaft to removably retain the thumb wheel on the outer shaft (Figs. 14 and 15, ¶s 79 and 80).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify/specify the thumb wheel and the spiral retaining ring as disclosed by the combination of Bess and Elsawah by adding a second retaining groove to the thumbwheel and specifying that the spiral retaining ring is a canted coil spring seated within the second retaining groove of the thumb wheel and within the first retaining groove of the outer shaft as taught by Elliott in order to releasably connect the thumb wheel and outer shaft (Bess ¶56; Elliott ¶79) to allow the outer shaft to translate in one direction while preventing translation in the opposite direction (Elliott ¶82).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Monday through Thursday, 6:30am-4pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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