Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 7 and 21 - 30 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding the argument that Jackson does not teach controlled playing a part of the arms relative to each other in the embodiment shown in figures 6 and 7 which teach an positive angle and perpendicular angle for the closure load flank, this is not found persuasive because Jackson discloses an amount of splaying in paragraphs [0059] in the form of “virtually no” as opposed to no splaying. Claim 1 require “controlled splaying” and “virtually no” meets the broad definition of controlled. In other words, “virtually no splaying” is a controlled splaying.
Regarding the rejection of claim 26 under 112(b), applicant states that claim 26 is amended to depend upon claim 27. However, no such amendment was found. In the most recent listing of claims, claim 26 is still dependent upon claim 27. For purposes of examination claim 26 is assumed to depend from claim 27.
Claim Objections
Claim 23 is objected to because of the following informalities:
Claim 23, “the closure central axis of the closure” should read “the central axis of the closure”.
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.
Claims 1 – 7 and 21 – 30 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is amended to recite “a decreased thread pitch contributes to an increased thrust for a given torque”. The terms “decreased” and “increased” are comparative terms and it not clear what they are comparing to. For purposes of examination any pitch in the range of 0.040 to 0.120 inches (paragraph [0052]) with torques in range of 75-to-125-inch pounds (paragraph [0052]) will fulfill the recited limitation as it meets the definition defined by applicant.
In addition, it is unclear if “a given torque” is the same as or different than “a torque of at least 75 in pounds”. For purposes of examination, they are assumed to be the same.
Claim 26 recites the elongate rod, but it unclear if the rod is part of the claimed invention or only functionally recited. For purposes of examination the rod is assumed to be part of the claimed invention. Claim 26 should be amended to depend from 27 or be amended to clarify the positive recitation of the elongate rod such as within claim 27.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 – 7 and 21 - 30 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson (US 2005/0182410 A1) in view of Keyer et al. (US 2016/0206350 A1).
Regarding claim 1, Jackson discloses a spinal fixation structure intended for use with an elongate rod (Abstract), the spinal fixation structure comprising:
a receiver housing (Fig. 1, ref. 11) having a central bore defining an inner surface in an upper portion of the central bore with an open channel (ref. 26) configured to receive the elongate rod (Fig. 1), and upright arms (ref. 28) having a discontinuous helically wound receiver thread formed therein (ref. 9), the discontinuous helically wound receiver thread having a receiver cylindrical root surface (see remarked Fig. 6 below), a base height adjacent the receiver cylindrical root surface measured as an axial distance extending parallel with respect to a longitudinal axis of the receiver housing (see remarked Fig. 6 below), a receiver linear load flank (ref. 39’, Fig. 6), and an opposed receiver linear stab flank (see remarked fig. 6 below); and
a closure (Fig. 1, ref. 1) having a closure central axis, a cylindrical body including a top end having a top surface, a bottom end having a bottom surface opposite the top surface (Fig. 1), a central internal drive structure extending into the cylindrical body centered along the closure central axis (Fig. 1, ref. 59), and an outer complementary mating helically wound closure thread formed thereon (ref. 4) and including a continuously wound closure linear load flank having a radially outwardly extending surface portion that angles upwardly toward the top end of the closure or extends perpendicularly relative to the closure central axis (Figs. 6 – 7 shows a parallel and upwardly angled embodiments), a closure linear stab flank having a radially outwardly extending linear clearance surface portion, and a closure cylindrical root surface defining an outer surface of the cylindrical body and a base height adjacent the closure cylindrical root surface measured as an axial distance extending parallel with respect to the closure central axis (see remarked Fig. 6 below), with the base height of the receiver thread being substantially equal to the base height of the closure thread (Fig. 3 shows the base heights being substantially equal),
where the closure thread is configured to engage the receiver thread to secure the elongate rod within the open channel of the receive housing in a locked configuration with a torque of at least 75-inch pounds (paragraph [0006]).
wherein threaded engagement of the closure and the receiver housing is such that axial loading between the receiver load flank and the closure load flank causes controlled splaying apart of the upright arms relative to each other (paragraph [0057] discloses limiting the splaying, thus allowing for controlled splaying),
wherein a clearance gap exists between the receiver linear stab flank and the closure linear stab flank when the spinal fixation structure is in the locked configuration (Fig. 6),
Jackson is silent that the closure thread has a thread pitch within a range of 0.040 inches and 0.070 inches and wherein a decreased thread pitch contributes to an increased thrust for a given torque, wherein the splaying apart of the upright arms increased with the torque so as to contribute to increased thrust.
Keyer teaches an analogous spinal fixation structure (Abstract) comprising a closure (ref. 103, Fig. 1) having a thread pitch of about 1.0 mm (paragraph [0052]). It is noted that about 1.0 mm converts to about 0.04 inches. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the closure thread pitch to be 1.0 mm (0.04 inches), as taught by Keyer, for the purpose of providing a fine pitch to improve adjustment precision and holding power. It is noted that the combination of Jackson in view of Keyer results in a pitch in the range of 0.04 to 0.07 inches and a torque of at least 75-inch pounds, and by applicant’s admission this results in a decreased thread pitch which contributes to an increased thrust for a given torque, wherein the splaying apart of the upright arms will increase with the torque so as to contribute to increased thrust.
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Regarding claim 2, Jackson in view of Keyer discloses the spinal fixation structure of claim 1, wherein the closure cylindrical root surface extends between an upper radiused surface communicating with the closure linear load flank and a lower radiused surface communicating with the closure linear stab flank (see remarked Fig. 6 below of Jackson).
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Regarding claim 3, Jackson in view of Keyer discloses the spinal fixation structure of claim 1, wherein the closure cylindrical root surface is parallel with respect to the closure central axis and helically wound around the cylindrical body of the closure (Jackson, Fig. 3).
Regarding claim 4, Jackson in view of Keyer discloses the spinal fixation structure of claim 1, wherein the closure thread includes a thread crest having an outer cylindrical surface portion extending parallel relative to the central axis of the closure, wherein a lower end of the outer cylindrical surface portion joins with a curvilinear surface at an outer end of the radially outwardly extending linear clearance surface portion of the closure linear stab flank (see remarked Fig. 6 below of Jackson).
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Regarding claim 5, Jackson in view of Keyer discloses the spinal fixation structure of claim 4, wherein the mating helically wound closure thread further comprises a toe defined between the radially outwardly extending surface portion of the closure linear load flank and the thread crest, the toe angling upward from the radially outwardly extending surface portion of the closure linear load flank (ref. 55, Jackson).
Regarding claim 6, Jackson in view of Keyer discloses spinal fixation structure of claim 1, wherein the bottom surface of the bottom end of the closure includes a central axial nub with a curvate surface protruding downward therefrom (Fig. 3, Jackson).
Regarding claim 7, Jackson in view of Keyer discloses the spinal fixation structure of claim 1, further comprising a shank configured to be received in the receiver housing (Fig. 20, ref. 154, Jackson).
Regarding claim 21, Jackson in view of Keyer discloses spinal fixation structure of claim 1, wherein the base height of the mating helically wound closure thread extends between a first upper radiused surface communicating with the closure linear load flank and a first lower radiused surface communicating with the closure linear stab flank (see remarked Fig. 6 above of Jackson).
Regarding claim 22, Jackson in view of Keyer discloses the spinal fixation structure of claim 1, wherein the base height of the receiver thread extends between a second upper radiused surface communicating with a receiver stab flank and a second lower radiused surface communicating with a receiver load flank (Fig. 6, Jackson).
Regarding claim 23, Jackson discloses the spinal fixation structure of claim 1, wherein the longitudinal axis of the receiver housing is aligned with the closure central axis of the closure (Fig. 1, Jackson).
Regarding claim 24, Jackson in view of Keyer discloses the spinal fixation structure of claim 1, wherein the radially outwardly extending surface portion of the continuously wound closure linear load flank is at a load flank angle relative to a horizontal axis, the load flank angle being the same for an entirety of the continuously wound closure linear load flank (Jackson, Fig. 3 shows the angle being constant along the length of the closure).
Regarding claim 25, Jackson in view of Keyer, discloses the spinal fixation structure of claim 1, wherein the radially outwardly extending linear clearance surface portion of the closure linear stab flank is at a stab flank angle relative to a horizontal axis, the stab flank angle being the same for an entirety of the continuously wound closure linear stab flank (Jackson, Fig. 3 shows the angle being constant along the length of the closure).
Regarding claim 26, Jackson in view of Keyer, discloses the spinal fixation structure of claim 1, wherein, in the locked configuration, the elongate rod is secured in position in the open channel of the receiver housing via the closure (Jackson, Fig. 2).
Regarding claim 27, Jackson in view of Keyer, discloses the spinal fixation structure of claim 1, further comprising the elongate rod (Jackson, Fig. 2, ref. 35).
Regarding claim 28, Jackson in view of Keyer, discloses the spinal fixation structure of claim 1, wherein controlled splaying apart of the upright arms with axial loading is permitted up until the locked configuration is achieved (Jackson, paragraph [0057 - 58] disclose limiting the splaying, thus a controlled playing. In addition, once the closure is fully inserted, the all of the splay control surfaces will be activated.).
Regarding claim 29, Jackson in view of Keyer, discloses the spinal fixation structure of claim 28, wherein the locked configuration is achieved when corresponding splay control ramps of the receiver housing and the closure, respectively, come into engagement so as to prevent splaying apart of the upright arms of the receiver housing (Jackson, Fig. 3, paragraphs [0057-58]).
Regarding claim 30, Jackson in view of Keyer, discloses the spinal fixation structure of claim 7, wherein the shank comprises a partially spherical shaped head configured to pivotally engage a spherical seating surface in the receiver housing (Jackson, paragraph [0065]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 which lists the prior art used in the current Office Action not already of record.
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 TESSA M MATTHEWS whose telephone number is (571)272-8817. The examiner can normally be reached M - F 8am - 1pm.
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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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/TESSA M MATTHEWS/Examiner, Art Unit 3773