Er4DETAILED 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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-12, and Species B, FIGS. 8A-9C, in the reply filed on 19 February 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4 and 13-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or group, there being no allowable generic or linking claim. Claim 4 is directed to nonelected Species A (at least the outer sleeve having an outer sleeve stop, and the inner shaft has a measuring portion, are directed to Species A), and claims 13-23 are directed to nonelected Group II.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 17/934,874, 63/247,345, 17,676,609, 17/347,492, 63/039,242, 63/349,136, 63/369,330, and 18/051,732, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior-filed applications fail to provide adequate support for an elevator tool as recited in the claims. The claims are afforded a priority date of 05 January 2023 as properly supported by prior-filed application 63/478,620.
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, “when the lock is not engaged with the handle, the handle and the distal paddle are able to rotate within the receiving portion of the outer sleeve” (claim 11) must be shown or the feature(s) canceled from the claim(s). The drawings do not show that the handle and the distal paddle are within the receiving portion of the outer sleeve, much less able to rotate within the receiving portion of the outer sleeve when the lock is not engaged. Rather, the inner shaft rotates within the receiving portion of the outer sleeve while the handle and the distal paddle are outside of the outer sleeve and rotate with respect to the outer sleeve. 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
Claims 5 and 9-12 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 5 / lines 5-6: “the
Claim 9 / line 18: “[[the]] an ipsilateral side”
Claim 10 / line 21: “manipulating the an ipsilateral side”
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.
Claims 8-12 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 8 / lines 4-5, the limitation “the at least one arm is configured to be rotated unconstrained at least about 360 degrees by the paddle handle assembly” renders the claim indefinite, because it is unclear the scope of the term “unconstrained” since the at least one arm is attached to the inner shaft which is constrained by/within the positioning grip. Although the at least one arm can be rotated at least about 360 degrees, it is constrained to a particular position in space due to the positioning grip. For examination purposes, the limitation will be interpreted as “the at least one arm is configured to be rotated at least about 360 degrees by the paddle handle assembly”.
As to claim 9 / lines 8-9, the limitation “with an inner shaft;” renders the claim indefinite, because it is unclear if this refers back to the previously recited inner shaft of claim 9 / line 6, or to a different inner shaft. For examination purposes, the limitation will be interpreted as “with the inner shaft;”.
As to claim 10 / lines 15-16, the limitation “with an inner shaft;” renders the claim indefinite, because it is unclear if this refers back to the previously recited inner shaft of claim 10 / line 13, or to a different inner shaft. For examination purposes, the limitation will be interpreted as “with the inner shaft;”.
As to claim 12 / lines 1-2, the limitation “the at least one arm is configured to be rotated through an unconstrained 360 degree rotation” renders the claim indefinite, because it is unclear the scope of the term “unconstrained” since the at least one arm is attached to the inner shaft which is constrained by/within the positioning grip. Although the at least one arm can be rotated 360 degrees, it is constrained to a particular position in space due to the positioning grip. For examination purposes, the limitation will be interpreted as “the at least one arm is configured to be rotated through a 360 degree rotation”.
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.
Claims 1-3 and 5-12 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. 4,654,028 to Suma.
As to claim 1, Suma discloses an elevator tool for preparing a surgical site for an implant device (interpreted as language of intended use; fully capable of use as an elevator tool), the elevator tool, FIGS. 6-11, comprising: a paddle handle assembly (18), FIG. 10; a distal paddle (21; the paddle comprising the elongated bodies and the broader tip at the ends of 21); the paddle handle assembly operably coupled to the distal paddle (col. 3 / lines 45-46) whereby the paddle handle assembly influences a movement of the distal paddle (since the distal paddle 21 is fixed to the paddle handle assembly 18 via inner shaft 17, movement of the paddle handle assembly results in movement of the distal paddle); and a positioning grip (16) extending between the paddle handle assembly and the distal paddle (col. 3 / lines 46-47), FIG. 10, whereby the positioning grip influences a position of the distal paddle (retraction of the positioning grip 16 results in an expanded position of the distal paddle, and advancement of the positioning grip results in a retracted position of the distal paddle within the positioning grip).
As to claim 2, Suma discloses the elevator tool of claim 1 wherein: the positioning grip comprises an outer sleeve (enlarged cylindrical portion at 22); the outer sleeve having a receiving portion (inner cannulation); and the paddle handle assembly is coupled to the distal paddle with an inner shaft (17), FIG. 7, extending through the receiving portion of the outer sleeve, FIG. 10.
As to claim 3, Suma discloses the elevator tool of claim 2 wherein: the outer sleeve is coupled to a shell (smaller diameter cylindrical portion of 16); the shell having a receiving portion (respective inner cannulation); and the inner shaft extending through the receiving portion of the shell, FIG. 10.
As to claim 5, Suma discloses the elevator tool of claim 1 further comprising: the paddle handle assembly coupled to the distal paddle with an inner shaft (17), FIG. 7; a lock (recess in proximal end of 22) coupled to the positioning grip, FIG. 6; the paddle handle assembly comprising a handle (18); and the lock configured to engage the handle (at 23) whereby when the lock is engaged with the paddle handle, the handle and the distal paddle are maintained in a locked position relative to the positioning grip (col. 3 / line 50 – col. 4 / line 2).
As to claim 6, Suma discloses the elevator tool of claim 1 wherein: the distal paddle comprises an elongated member having at least one arm (one arm of 21) extending from a rotational axis (extends away from a central rotational axis of 17 in the expanded configuration, FIGS. 7 and 10); and the at least one arm is configured to be rotated at least about 90 degrees by the paddle handle assembly (the at least one arm and the inner shaft 17 to which it is attached are capable of being rotated freely by the paddle handle assembly about the central rotational axis of 17, at least about 90 degrees and a full 360 degrees, since the inner shaft 17 rotates freely within the positioning grip 16 when the lock is not engaged, and also since the entire device as a whole can be rotated freely in space by handling of the paddle handle assembly).
As to claim 7, Suma discloses the elevator tool of claim 1 wherein: the distal paddle comprises an elongated member having at least one arm (one arm of 21) extending from a rotational axis (extends away from a central rotational axis of 17 in the expanded configuration, FIGS. 7 and 10); and the at least one arm is configured to be rotated at least about 180 degrees by the paddle handle assembly (the at least one arm and the inner shaft 17 to which it is attached are capable of being rotated freely by the paddle handle assembly about the central rotational axis of 17, at least about 180 degrees and a full 360 degrees, since the inner shaft 17 rotates freely within the positioning grip 16 when the lock is not engaged, and also since the entire device as a whole can be rotated freely in space by handling of the paddle handle assembly).
As to claim 8, Suma discloses the elevator tool of claim 1 wherein: the distal paddle comprises an elongated member having at least one arm (one arm of 21) extending from a rotational axis (extends away from a central rotational axis of 17 in the expanded configuration, FIGS. 7 and 10); and the at least one arm is configured to be rotated unconstrained at least about 360 degrees by the paddle handle assembly (the at least one arm and the inner shaft 17 to which it is attached are capable of being rotated freely and unconstrained by the paddle handle assembly about the central rotational axis of 17, at least about a full 360 degrees, since the inner shaft 17 rotates freely within the positioning grip 16 when the lock is not engaged, and also since the entire device as a whole can be rotated freely in space by handling of the paddle handle assembly).
As to claim 9, Suma discloses the elevator tool of claim 1 wherein: the positioning grip comprises an outer sleeve (enlarged cylindrical portion at 22); the outer sleeve having a receiving portion (inner cannulation); the outer sleeve coupled to a shell (smaller diameter cylindrical portion of 16); the shell having a receiving portion (respective inner cannulation); the paddle handle assembly is coupled to the distal paddle with an inner shaft (17), FIG. 7, extending through the receiving portion of the outer sleeve and the receiving portion of the shell, FIG. 10; the paddle handle assembly comprises a handle (18) coupled to the distal paddle with an inner shaft (17), FIG. 7; the elevator tool further comprises a lock (recess in proximal end of 22) coupled to the positioning grip, FIG. 6; the lock configured to engage the handle (at 23) whereby when the lock is engaged with the handle, the handle and the distal paddle are maintained in a locked position relative to the positioning grip (col. 3 / line 50 – col. 4 / line 2); the distal paddle comprises an elongated member having at least two arms (two arms of 21) extending from a rotational axis (each arm extends away from a central rotational axis of 17 in the expanded configuration, FIGS. 7 and 10); and the at least two arms are configured to be rotated at least about 180 degrees by the handle (the at least two arms and the inner shaft 17 to which they are attached are capable of being rotated freely by the handle about the central rotational axis of 17, at least about 180 degrees and a full 360 degrees, since the inner shaft 17 rotates freely within the positioning grip 16 when the lock is not engaged, and also since the entire device as a whole can be rotated freely in space by handling of the handle) whereby the at least two arms are configured to remove obstructions on a contralateral side of a vertebral body by manipulating the handle oriented on the ipsilateral side of the vertebral body (interpreted as language of intended use; the arms are fully capable of removing obstructions if placed adjacently to the obstructions to push or grasp the obstructions, and the arms are fully capable of action on a contralateral side of a vertebral body by manipulating the handle oriented on the ipsilateral side of the vertebral body since the inner shaft 17 is elongated and can extend across the vertebral body and transfer movement from the handle to the arms).
As to claim 10, Suma discloses an elevator tool for use in preparing a contralateral side of a vertebral body for an orthopedic implant (interpreted as language of intended use; fully capable of use as an elevator tool for use in preparing any side of a tissue where it is placed), the elevator tool, FIGS. 6-11, comprising: a paddle handle assembly (18), FIG. 10; a distal paddle (21; the paddle comprising the elongated bodies and the broader tip at the ends of 21); the paddle handle assembly operably coupled to the distal paddle (col. 3 / lines 45-46) whereby the paddle handle assembly influences a movement of the distal paddle (since the distal paddle 21 is fixed to the paddle handle assembly 18 via inner shaft 17, movement of the paddle handle assembly results in movement of the distal paddle); a positioning grip (16) extending between the paddle handle assembly and the distal paddle (col. 3 / lines 46-47), FIG. 10, whereby the positioning grip influences a position of the distal paddle (retraction of the positioning grip 16 results in an expanded position of the distal paddle, and advancement of the positioning grip results in a retracted position of the distal paddle within the positioning grip); the positioning grip comprises an outer sleeve (enlarged cylindrical portion at 22); the outer sleeve having a receiving portion (inner cannulation); the outer sleeve coupled to a shell (smaller diameter cylindrical portion of 16); the shell having a receiving portion (respective inner cannulation); the paddle handle assembly is coupled to the distal paddle with an inner shaft (17), FIG. 7, extending through the receiving portion of the outer sleeve and the receiving portion of the shell, FIG. 10; the paddle handle assembly comprises a handle (18) coupled to the distal paddle with an inner shaft (17), FIG. 7; the distal paddle comprises an elongated member having at least one arm (one arm of 21) extending from a rotational axis (extends away from a central rotational axis of 17 in the expanded configuration, FIGS. 7 and 10); and the at least one arm is configured to be rotated by the handle (the at least one arm and the inner shaft 17 to which it is attached are capable of being rotated freely by the handle about the central rotational axis of 17, since the inner shaft 17 rotates freely within the positioning grip 16 when the lock is not engaged, and also since the entire device as a whole can be rotated freely in space by handling of the handle) whereby the at least one arm is configured to remove obstructions on the contralateral side of the vertebral body by manipulating the paddle handle from a position oriented on the ipsilateral side of the vertebral body (interpreted as language of intended use; the arm is fully capable of removing obstructions if placed adjacently to the obstructions to push or grasp the obstructions, and the arm is fully capable of action on a contralateral side of a vertebral body by manipulating the handle from a position oriented on the ipsilateral side of the vertebral body since the inner shaft 17 is elongated and can extend across the vertebral body and transfer movement from the handle to the arm).
As to claim 11, Suma discloses the elevator tool of claim 10 wherein: the elevator tool further comprises a lock (recess in proximal end of 22) coupled to the positioning grip, FIG. 6; and the lock configured to engage the handle (at 23) whereby when the lock is engaged with the handle, the handle and the distal paddle are maintained in a locked position relative to the positioning grip (col. 3 / line 50 – col. 4 / line 2) and when the lock is not engaged with the handle, the handle and the distal paddle are able to rotate within the receiving portion of the outer sleeve (at least as much as the instant invention; the handle and the distal paddle rotate relative to the outer sleeve when the lock is not engaged).
As to claim 12, Suma discloses the elevator tool of claim 11 wherein the at least one arm is configured to be rotated through an unconstrained 360 degree rotation when the lock is not engaged with the handle (when the lock is not engaged with the handle, the arm and the inner shaft 17 to which it is attached are capable of being rotated freely and unconstrained by the handle about the central rotational axis of 17, about a full 360 degrees, since the inner shaft 17 rotates freely within the positioning grip 16 when the lock is not engaged, and also since the entire device as a whole can be rotated freely in space by handling of the handle).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775