DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/22/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 – 4, 6 – 11 and 19 – 27 are 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 19 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 19 recites “a second thread depth defined as a horizontal distance between the thread root and the cylindrical crest surface, wherein the outer thread height is substantially equal to the second thread depth”. This was not found in the organically filed application and is therefore considered new matter. In addition, it is unclear how the second thread depth would be different than the first thread depth since the base and root would be aligned along the same axis. See remarked Fig. 2 below.
PNG
media_image1.png
548
797
media_image1.png
Greyscale
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 – 4, 6 – 11, 19, 20 and 22 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 recites “a closure thread root” and “a thread root” for the threaded closure. It is unclear if these are meant to be the same or different. For purposes of examination they are assumed to be the same and “a thread root” will be read as “the closure thread root”.
Claim 1 recites “a bottom side of the outer continuously helically wound thread, the closure stab flank continuous helically wound thread;”. It is unclear what this limitation is meant to convey. For purposes of examination the stab flank is assumed to be part of the outer continuously helically wound thread of the threaded closure and the limitation will be read as “a bottom side of the outer continuously helically wound thread;”.
Claim 1 recites “wherein the first thread depth is less than the base height”. It is unclear if this base height is the first heigh of the receiver or the second height of the closure. For purposes of examination the base height is assumed to be the second height.
Claim 22 recites an upper and lower radiused surface. It is unclear if these surfaces are the same as or different than the partially rounded surfaces and junctures of claim 21. For purposes of examination they are assumed to be the same.
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.
Claim 1 – 4, 6, 10, 11 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson (US 2006/00587794 A1) in view of DeLange et al. (US 5,092,635).
Regarding claim 1, Jackson discloses a spinal fixation structure configured to limit splay (Abstract, Figs. 4 - 6), the spinal fixation structure comprising:
a receiver (Fig. 1, ref. 11) comprising a central receiver axis (Fig. 3, ref. 41), a pair of upright arms (Fig. 1, ref. 28), an open channel defined between the pair of upright arms and configured to receive an elongate rod therein (ref. 30), each of the pair of upright arms comprises an inner surface with a portion of a helically wound thread formed therein (Fig. 1, ref. 9) with a receiver load flank (ref. 46) having a first linear surface portion and a first thread base with a first height adjacent a receiver thread root (Fig. 7 of US Pat. No. 8,876,868, incorporated by reference in paragraph [0001], see below), the pair of upright arms tending to splay apart from each other when subject to an axial load (Abstract);
a threaded closure (Fig. 1, ref. 6) comprising a central closure axis (Fig. 3, ref. 41), a cylindrical body including a top end having a top surface, a bottom end having a bottom surface opposite the top surface (Fig. 3), a cylindrical closure outer surface (Fig. 3), a central internal drive structure extending into the top end (Fig. 2, ref. 61), and an outer continuous helically wound thread formed on the cylindrical outer surface (ref. 1), the outer continuous helically wound thread having a second thread base with a second height adjacent a closure thread root defined by the cylindrical outer closure surface (see remarked Fig. 7 below) and comprising:
a thread root extending along and parallel with respect to the cylindrical outer closure surface and the central closure axis and defining an innermost portion of the cylindrical body of the outer continuous helically wound thread (see remarked Fig. 7 below);
a cylindrical crest surface extending parallel with respect to the central closure axis and defining an outermost surface of the cylindrical body of the outer continuous helically wound thread (see remarked Fig. 7 below);
a closure load flank extending outwardly between the innermost portion and the cylindrical crest surface on a top side of the outer continuous helically wound thread (see remarked Fig. 7 below), the closure load flank adjacent to the innermost portion and comprising a second linear surface portion defined on the top side of the outer continuous helically wound thread, the second linear surface portion with a slope angle sloping towards the top end of the threaded closure (see remarked Fig. 7 below);
a closure stab flank extending between the thread root and the cylindrical crest surface on a bottom side of the outer continuous helically wound thread (see remarked Fig. 7 below), the closure stab flank comprising a third linear surface portion defined on the bottom side of the outer continuous helically wound thread (Fig. 7);
a first thread depth defined as a horizontal distance between the cylindrical crest surface and a line defining the second height of the second thread base (see remarked Fig. 7 below); and
a thread pitch defined as a vertical distance from a location on the cylindrical crest surface of one helically wound thread to the same location on an adjacent helically wound thread,
wherein the bottom surface of the bottom end of the cylindrical body of the threaded closure is configured to engage the elongate rod with 70 to 140 inch pounds of applied torque (the closure is fully capable of being advanced with such a torque), when positioned within the open channel of the receiver (Fig. 2), and
wherein, when the elongate rod is positioned in the open channel and the threaded closure is advanced against the elongate rod, splay between the pair of upright arms is controlled by a limited amount of permissible sliding between the first linear surface portion of the receiver load flank of the receiver and the second linear surface portion of closure load flank so as to create a maximum thrust of the closure against the elongate rod for a given amount of torque (a comparison between figures 4 and 5 show a limited amount of splaying in Fig. 4 to a more allowed amount splaying in Fig. 5 when the load flanks are slid along one another and clearance between the crest surface and the receiver is changed and in U.S. Pat. No. 8,876,868 recites a limiting of splaying in (33) of the written description).
Jackson is silent that the first thread depth is less than the base height.
DeLagne teaches a buttress thread form in the related field of threading wherein a thread depth (Fig. 3, L3) is less than a base height (Fig. 2, L1, (7) written description). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the thread such that the first thread depth is less than the second height, as taught by DeLange, for the purpose of better load distribution and reduced stress concentration.
PNG
media_image2.png
598
956
media_image2.png
Greyscale
Regarding claim 2, Jackson in view of DeLange discloses the spinal fixation structure of claim 1, further comprising the elongate rod (Jackson, Fig. 2, ref. 35).
Regarding claim 3, Jackson in view of DeLange discloses the spinal fixation structure of claim 1, further comprising a bone screw shank being positionable in the receiver (Jackson, Fig. 6).
Regarding claim 4, Jackson in view of DeLange discloses the spinal fixation structure of claim 1, wherein the closure stab flank has a slope angle sloping toward the top end of the threaded closure (see remarked Fig. 7 above).
Regarding claim 6, Jackson in view of DeLange discloses the spinal fixation structure of claim 3, wherein the bone screw shank is pivotal with respect to the receiver (Jackson, Fig. 6).
Regarding claim 10, Jackson in view of DeLange discloses the spinal fixation structure of claim 1, wherein the torque of 70 to 140 inch pounds is configured to be applied to the threaded closure to secure the elongate rod in the receiver (Jackson, paragraph [0006]).
Regarding claim 11, Jackson in view of DeLange discloses the spinal fixation structure of claim 10, wherein the torque ranges from 70 to 120 inch pounds or from 80 to 120 inch pounds (Jackson, paragraph [0006]).
Regarding claim 20, Jackson in view of DeLange discloses the spinal fixation structure of claim 1, wherein the first height of the first thread base is substantially equal to the second height of the second thread base (Jackson shows the thread heights to be substantially equal) but is silent that the heights are equal. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal fixation structure of Jackson in view of DeLange such that the heights are equal for better complimentary mating and ease of manufacture and since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 7 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson (US 2006/0058794 A1) in view of DeLange et al. (US 5,092,635) and in view of Biedermann et al. (US 2010/0087865 A1).
Regarding claim 7, Jackson in view of DeLange discloses the spinal fixation structure of claim 3, except wherein the bone screw shank and the receiver are configured such that the bone screw shank is top-loadable into the receiver. It is noted that Fig. 6 appears as though the channel is wide enough to receive the bone screw from the top, however there is no explicit disclosure to a top-loadable screw.
Biedermann teaches an analogous spinal fixation structure (Abstract) where the bone screw is configured to be top-loaded (paragraph [0036]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal fixation structure of Jackson in view of DeLange such that the bone screw shank is top-loadably into the receiver, as taught by Biedermann, for the purpose of allowing for larger bone screw heads which can better distribute loads and have higher resistance to pull-out forces.
Claims 8 - 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson (US 2006/0058794 A1) in view of DeLange et al. (US 5,092,635) and in view of Jackson (US 2026/0123965 A1).
Regarding claim 8, Jackson in view of DeLange discloses the spinal fixation structure of claim 3, except for further comprises a pressure insert configured to engage with an upper head portion of the shank and to receive the elongate rod.
Jackson teaches an analogous spinal fixation structure (Abstract) comprising a pressure insert (ref. 14) configured to engage with an upper head portion of a shank (Fig. 32) and to receive the elongate rod (Fig. 32). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the spinal fixation structure of Jackson in view of DeLange to include the pressure insert, as taught by Jackson, for the purpose of frictionally engaging the head of the bone screw to aid in holding a desired angular orientation of the bone screw (paragraphs [0093-95]).
Regarding claim 9, Jackson (794) in view of DeLange and in view of Jackson (965) discloses the spinal fixation structure of claim 8, wherein the bone screw shank and the receiver are configured such that the bone screw shank is bottom-loadable and held in the receiver with the pressure insert (both Jackson (794) and Jackson (965) disclose bottom loading bone screws, see Jackson 6,716,214 incorporated by reference Fig. 9 and Title of Jackson (965)).
Claim 21 - 27 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Jackson (US 2005/0182410 A1) in view of DeLange et al. (US 5,092,635).
Regarding claim 21, Jackson discloses a spinal fixation structure intended for use with an elongate rod (Abstract), the spinal fixation structure comprising:
a receiver housing (Fig. 20, ref. 152) having a central bore defining an inner surface in an upper portion of the central bore with an open channel configured to receive the elongate rod (Fig. 20), and a pair of upright arms (ref. 166) having a discontinuous helically wound receiver thread formed therein (ref. 1), the discontinuous helically wound receiver thread having a receiver cylindrical root surface, a receiver linear load flank, and an opposed receiver linear stab flank (see remarked Fig. 6 below), the pair of upright arms tending to splay apart from each other when subject to an axial load (paragraph [0057]); and
a closure (Fig. 20, ref. 172) having a closure central axis (Fig. 3, ref. 41), a cylindrical body including a top end having a top surface (Fig. 3), a bottom end having a bottom surface opposite the top surface (Fig. 3), a central internal drive structure extending into the cylindrical body centered along the closure central axis (Fig. 2), and an outer complementary mating closure thread with the same continuously helically wound geometry formed thereon (ref. 1, paragraph [0065]) and including a 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 (see remarked Fig. 6 below), a closure linear stab flank having a radially outwardly extending linear clearance surface portion (see remarked Fig. 6 below), an outer closure crest surface, and a closure cylindrical root surface defining an outer surface of the cylindrical body (Fig. 6), the closure linear load flank connected to a closure cylindrical root surface by a partially rounded surface having a juncture at both ends therebetween (see remarked Fig. 6 below), and a base height adjacent to the closure cylindrical root surface measured as an axial distance by a line extending parallel with respect to the closure central axis from the juncture of rounded surface with the closure linear load flank down to a juncture with the closure linear stab flank (Fig. 6), and a thread depth defined as a horizontal distance between the closure crest surface and the line defining the base height (Fig. 6),
wherein the closure thread is configured to engage the receiver thread to secure the elongate rod within the open channel of the receiver housing in a locked configuration with an applied torque of 70 to 140 inch pounds to create a downward force of the closure against the rod (Figs. 1 and 20 show a break off head which is fully capable of receiving a strong torque, see paragraph [0064], such as in the range of 70 to 140 inch pounds), and
wherein a clearance gap exists between the receiver linear stab flank and the closure linear stab flank and between the receiver cylindrical root surface and the closure crest surface when the spinal fixation structure is in the locked configuration (Fig. 6), and
wherein, when the elongate rod is positioned in the open channel and the threaded closure is advanced against the elongate rod, splay between the pair of upright arms is controlled by a limited amount of permissible sliding between the first linear surface portion of the receiver load flank of the receiver and the second linear surface portion of closure load flank so as to create the downward force of the closure against the rod (paragraph [0055-58]).
Jackson is silent that the first thread depth is less than the base height.
DeLagne teaches a buttress thread form in the related field of threading wherein a thread depth (Fig. 3, L3) is less than a base height (Fig. 2, L1, (7) written description). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the thread such that the first thread depth is less than the second height, as taught by DeLange, for the purpose of better load distribution and reduced stress concentration.
PNG
media_image3.png
414
638
media_image3.png
Greyscale
PNG
media_image4.png
393
682
media_image4.png
Greyscale
Regarding claim 22, Jackson in view of DeLange discloses the spinal fixation structure of claim 21, 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 (Jackson, Fig. 6).
Regarding claim 23, Jackson in view of DeLange discloses the spinal fixation structure of claim 21, 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. 6).
Regarding claim 24, Jackson in view of DeLange discloses the spinal fixation structure of claim 21, wherein the closure thread crest surface includes 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 (Jackson, Fig. 6).
Regarding claim 25, Jackson in view of DeLange discloses the spinal fixation structure of claim 24, 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 (Jackson, Fig. 6).
Regarding claim 26, Jackson in view of DeLange discloses the spinal fixation structure of claim 21, wherein the bottom surface of the bottom end of the closure includes a central axial nub with a curvate surface protruding downward therefrom (Jackson, Fig. 3).
Regarding claim 27, Jackson in view of DeLange discloses the spinal fixation structure of claim 21, further comprising a shank configured to be received in the receiver housing (Jackson, Fig. 20, ref. 154).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TESSA M MATTHEWS/Examiner, Art Unit 3773
