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 .
Drawings
The drawings were received on January 31, 2026. These drawings have been entered.
Claim Objections
Claim 12 is objected to because of the following informalities: there should be a semicolon between “screw” and “and” (line 7). Appropriate correction is required.
Claim 12 is objected to because of the following informalities: the period after “reducer” should be a semicolon (line 11). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 5 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 5 recites the limitation "the ramped or conical portion of the distal portion" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Because claim 4 recites that the distal end includes a ramped or conical portion, the Examiner is interpreting claim 5 as reciting “the ramped or conical portion of the distal end.”
Claim 11 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 11 recites the limitation "the ramped or conical portion of the distal portion" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Because claim 10 recites that the distal end includes a ramped or conical portion, the Examiner is interpreting claim 11 as reciting “the ramped or conical portion of the distal end.”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claims 1, 4-6, 8-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (US 5,578,035 A).
Claim 1. Lin discloses a device (see Figs. 2a-2b) for removing a reducer from a tulip of a spinal screw comprising:
one or more actuating members (diameter-adjusting elements 200; see Fig. 2a inset) configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw; and
a ram (urging element 400) having a tapered distal end (urging end 410) slidably coupled to the one or more actuating members configured to move the one or more actuating members outwardly from a stored position (see Fig. 2a) to a deployed position (see Fig. 2b);
wherein during distal movement of the ram, the one or more actuating members are is configured to slide along the tapered distal end and move outwardly (compare Fig. 2b to Fig. 2a) and push the locking reducer clips in an outward direction to uncouple with the tulip recesses and unlock the reducer from the tulip (Figs. 2a-2b; col. 4, ll. 5-16). Note that “for removing a reducer from a tulip of a spinal screw,” “configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw,” and “configured to … push the locking reducer clips in an outward direction to uncouple with the tulip recesses and unlock the reducer from the tulip” are all intended use statements, and the Examiner is taking the position that the device of Lin is capable of performing in such a manner.
Claim 4. Lin discloses wherein the tapered distal end includes a distal portion (distal-most tip of urging end 410; see Fig. 2a inset) having a first diameter, a ramped or conical portion (see Fig. 2a inset) that transitions from the first diameter to a second diameter, and a proximal portion (see Fig. 2a inset) having the second diameter, the second diameter being larger than the first diameter (Figs. 2a-2b; col. 4, ll. 5-16).
Claim 5. Lin discloses wherein when the one or more actuating members are in contact with the first diameter of the distal portion they are in the stored position (when the distal-most tip of urging end 410 first contacts diameter-adjusting elements 200, they would still be in the stored position), when the one or more actuating members are in contact with the ramped or conical portion of the distal end they move outwardly from the stored position to the deployed position (would occur prior to reaching the position shown in Fig. 2b), and when the one or more actuating members are in contact with the second diameter of the proximal portion they stay in the deployed position (see Fig. 2b) (Figs. 2a-2b; col. 4, ll. 5-16).
Claim 6. Lin discloses a tubular body (tubular body 100) configured for insertion in a reducer, the one or more actuating members are coupled to the tubular body (via holding elements 220 and retaining device 150) and the ram is slidably positioned in the tubular body (urging element 400 slides along threads of hollow interior 120 during rotation), wherein during distal movement of the ram in the tubular body, the tapered distal end slidingly engages the one or more actuating members to move them outwardly from the stored position to the deployed position (Figs. 2a-2b; col. 4, ll. 5-16). Note that “configured for insertion in a reducer” is an intended use statement, and the Examiner is taking the position that the device of Lin is capable of performing in such a manner.
Claim 8. Lin discloses a device (see Figs. 2a-2b) for removing a reducer from a tulip of a spinal screw comprising:
one or more actuating members (diameter-adjusting elements 200; see Fig. 2b inset) configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw; and
a ram (urging element 400) having a tapered distal end (urging end 410) slidably coupled to the one or more actuating members, the tapered distal end configured to engage the one or more actuating members to move them outwardly from a stored position (see Fig. 2a) to a deployed position (see Fig. 2b);
wherein the outward movement of the one or more members is configured to push the locking reducer clips outward to disengage with the tulip recesses and unlock the reducer from the tulip (Figs. 2a-2b; col. 4, ll. 5-16). Note that “for removing a reducer from a tulip of a spinal screw,” “configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw,” and “configured to push the locking reducer clips outward to disengage with the tulip recesses and unlock the reducer from the tulip” are all intended use statements, and the Examiner is taking the position that the device of Lin is capable of performing in such a manner.
Claim 9. Lin discloses a tubular body (tubular body 100) configured for insertion in a reducer, the one or more actuating members coupled to the tubular body (via holding elements 220 and retaining device 150) and the ram is slidably positioned in the tubular body (urging element 400 slides along threads of hollow interior 120), wherein during distal movement of the ram in the tubular body, the tapered distal end slidingly engages the one or more actuating members to move them outwardly from the stored position to the deployed position (Figs. 2a-2b; col. 4, ll. 5-16). Note that “configured for insertion in a reducer” is an intended use statement, and the Examiner is taking the position that the device of Lin is capable of performing in such a manner.
Claim 10. Lin discloses wherein the tapered distal end includes a distal portion (distal-most tip of urging end 410; see Fig. 2a inset) having a first diameter, a ramped or conical portion (see Fig. 2a inset) that transitions from the first diameter to a second diameter, and a proximal portion (see Fig. 2a inset) having the second diameter, the second diameter being larger than the first diameter (Figs. 2a-2b; col. 4, ll. 5-16).
Claim 11. Lin discloses wherein when the one or more actuating members are in contact with the first diameter of the distal portion they are in the stored position (when the distal-most tip of urging end 410 first contacts diameter-adjusting elements 200, they would still be in the stored position), when the one or more actuating members are in contact with the ramped or conical portion of the distal end they move outwardly from the stored position to the deployed position (would occur prior to reaching the position shown in Fig. 2b), and when the one or more actuating members are in contact with the second diameter of the proximal portion they stay in the deployed position (see Fig. 2b) (Figs. 2a-2b; col. 4, ll. 5-16).
Claim 12. Lin discloses a device (see Figs. 2a-2b) for removing a reducer from a tulip of a spinal screw comprising:
a tubular body (tubular body 100) configured for insertion in a reducer having a locking mechanism;
one or more actuating members (diameter-adjusting elements 200; see Fig. 2b inset) coupled to the tubular body, the one or more actuating members configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw; and
a ram (urging element 400) slidably positioned in the tubular body (urging element 400 slides along threads of hollow interior 120 during rotation), the ram having a tapered distal end (urging end 410) configured to engage the one or more actuating members to move them outwardly from a stored position (see Fig. 2a) to a deployed position (see Fig. 2b) to engage the locking mechanism of the reducer;
wherein the outward movement of the one or more actuating members is configured to push the locking reducer clips outward to disengage with the tulip recesses and unlock the reducer from the tulip (Figs. 2a-2b; col. 4, ll. 5-16). Note that “for removing a reducer from a tulip of a spinal screw,” “configured for insertion in a reducer having a locking mechanism,” “configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw,” “to engage the locking mechanism of the reducer,” and “configured to push the locking reducer clips outward to disengage with the tulip recesses and unlock the reducer from the tulip” are all intended use statements, and the Examiner is taking the position that the device of Lin is capable of performing in such a manner.
[AltContent: textbox (Distal Portion)][AltContent: textbox (Proximal Portion)][AltContent: textbox (Ramped Portion)][AltContent: textbox (Actuating Members)]
Claims 1 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (WO 2021/006665 A1). See US 2022/0287756 A1 for an English-language equivalent.
Claim 1. Lee discloses a device (removal apparatus 10) for removing a reducer from a tulip of a spinal screw comprising:
one or more actuating members (polygonal extensions 120, which are each separated by a gap) configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw; and
a ram (handle 200) having a tapered distal end (pressing part 230) slidably coupled to the one or more actuating members configured to move the one or more actuating members outwardly from a stored position (see Fig. 3) to a deployed position (see Fig. 4);
wherein during distal movement of the ram, the one or more actuating members are is configured to slide along the tapered distal end and move outwardly (compare Fig. 4 to Fig. 3) and push the locking reducer clips in an outward direction to uncouple with the tulip recesses and unlock the reducer from the tulip (Figs. 1-8). Note that “for removing a reducer from a tulip of a spinal screw,” “configured to engage locking reducer clips positioned within tulip recesses locking the reducer to the tulip of the spinal screw,” and “configured to … push the locking reducer clips in an outward direction to uncouple with the tulip recesses and unlock the reducer from the tulip” are all intended use statements, and the Examiner is taking the position that the device of Lee is capable of performing in such a manner.
Claim 7. Lee discloses wherein continued distal movement of the ram is further configured to contact a rod or set screw within the tulip and push the reducer off of the spinal screw (Figs. 1-8). Note that “configured to contact a rod or set screw within the tulip and push the reducer off of the spinal screw” is an intended use statement, and the Examiner is taking the position that the device of Lee is capable of performing in such a manner due to the opening at the free end of polygonal extensions 120.
Response to Arguments
Applicant's arguments filed January 31, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments regarding Lin and Lee focus on intended use recitations (see the first and third bullet points) regarding the manner in which the device acts on a reducer and a tulip (see pgs. 7-9). A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, as stated in the rejections above, the devices of Lin and Lee are capable of acting on a tulip and a reducer in the manner recited in the claims. The Examiner notes that the claims are not directed to a system including the device, the reducer, and the tulip, but are merely directed to the device. Thus, Lin and Lee need not disclose a reducer or tulip, but must merely be capable of performing in the manner claimed.
Applicant also merely presents a statement that Lin and Lee fail to disclose a ram as claimed and that the ram affects the actuating members as claimed (see the second and third bullet points). However, as stated in the rejections above, Lin and Lee satisfy these limitations.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIANNA N HARVEY whose telephone number is (571)270-3815. The examiner can normally be reached Mon.-Fri. 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIANNA N HARVEY/Primary Examiner, Art Unit 3773