Detailed Action
This is the first office action on the merits for US application number 18/830,270.
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 A) Orthopedic component species 1) of Figs. 1, 3, 4, and 5, B) Hole shape 1) of Figs. 1, 3, 4, and 5, C) Screw shank 1) of Figs. 1-4, 6, 24, and 20, and D) Locking cap system 2) of Figs. 4, 11-15, 24, 25, and 30 in the reply filed on August 26, 2026 is acknowledged, which indicated that claims 1-3, 5, 6, 8, 9, and 21 read on the elected species. 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)).
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) 1-3, 5, 6, 8, 9 and 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 system suitable for affixing an orthopedic component to a bone using a screw, the system comprising: a substantially rigid orthopedic component” in lines 1-3 and how it can be reasonably construed that a system for affixing a component comprises such a component. Examiner is interpreting this as referring to as “A system suitable for affixing
Claim(s) 1 recites/recite the limitation "the direction of the longitudinal axis" in line 12. There is insufficient antecedent basis for this limitation in the claim. Examiner is interpreting this as referring to, and suggests amending as, “a plurality of longitudinal splines generally extending in [[the]]a direction of the longitudinal axis,”.
Claim(s) 3 is/are unclear with regards to “the plurality of longitudinal splines are formed by recesses in the crown” that are in addition to the valleys of claim 1 line 14 or how a valley formed by a recess can be reasonably construed to be further limiting. Examiner is interpreting this as “the plurality of longitudinal valleys are formed by recesses in the crown” and suggests amending to clarify.
Claim(s) 2, 5, 6, 8, 9 and 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) 1-3, 5, 6, 9 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gnos et al. (EP 0988833 and corresponding machine translation, hereinafter “Gnos”) in view of Orbay et al. (US 2006/0009771, hereinafter “Orbay”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1-3, 5, 6, 9, and 21, Gnos discloses a system (Fig. 6) capable of affixing to a bone (Fig. 6, ¶15), the system comprising: a substantially rigid orthopedic component (1) having a hole (see illustration of Fig. 6, Fig. 6, ¶15) with a diameter (Figs. 5 and 6, ¶15), the hole comprising an entry side (see illustration of Fig. 6, Fig. 6) and an exit side (see illustration of Fig. 6, Fig. 6), the entry side of the hole comprising an internal helical thread (see illustration of Fig. 6, Fig. 6), and the exit side of the hole comprising an internal concave base (5, Fig. 6, ¶s 10 and 15); a screw (2, Fig. 6) having a longitudinal axis (vertical as shown in Fig. 6, Fig. 6), a leading end (Fig. 6), a trailing end (Fig. 6), and a cylindrical shaft (Fig. 6) extending therebetween (Fig. 6), the trailing end of the screw comprising a head (3, Fig. 6) having a convex base (4, Fig. 6, ¶16) capable of engaging the concave base of the hole (Fig. 6, ¶16) and a convex crown (see illustration of Fig. 6, Fig. 6), the cylindrical shaft comprising an external helical thread (see illustration of Fig. 6, Fig. 6) capable of engaging said bone (¶15) and having a shaft diameter (Fig. 6) smaller than the hole diameter (Fig. 6, ¶15); the crown comprising a screw socket (16) capable of accepting torque from a driver tool (Fig. 6, ¶s 10 and 15), a locking cap (6) comprising a proximal end (Fig. 6), a distal end (Fig. 6), and a substantially cylindrical body extending therebetween (Figs. 5 and 6, ¶15), the body comprising an external helical thread (7) capable of engaging the internal helical thread of the hole (Fig. 6, ¶16), the proximal end comprising a cap socket (18) capable of accepting torque from a driver tool (Fig. 6), and the distal end defining a substantially circular contact edge (see illustration of Fig. 6, Fig. 6), the contact edge capable of impinging on a plurality of longitudinal crests on the head of the screw when the locking cap is inserted in the hole (Fig. 6, ¶s 5 and 15); wherein the contact edge of the locking cap defines a substantially circular contact path (Figs. 5 and 6, ¶15) on the plurality of longitudinal crests that the contact edge is capable of impinging upon when inserted and tightened into the hole after the screw is fully inserted into the hole (Figs. 5 and 6, ¶15). As to claim 2, Gnos discloses that the screw is capable of being inserted in a plurality of angles with respect to the orthopedic component (Fig. 6, ¶s 1, 5, 10, and 15); and the screw is substantially impeded from changing angles with respect to the orthopedic component when fully inserted into the hole and after the locking cap is inserted into the hole and tightened against the head of the screw (Fig. 6, ¶s 1, 5, 10, and 15). As to claim 5, Gnos discloses that the contact path has a length between 20% and 70% of a circumference of the contact edge (Fig. 6, ¶s 10 and 15). As to claim 6, Gnos discloses that the contact path has a length between 40% and 60% of a circumference of the contact edge (Fig. 6, ¶s 10 and 15). As to claim 9, Gnos discloses that the internal helical thread of the orthopedic component has an axis in a direction (Fig. 6) normal to an upper surface of the orthopedic component (Fig. 6). As to claim 21, Gnos discloses that the contact edge is capable of cutting into or deforming the crown of the head of the screw when the locking cap is tightened against the head of the screw (Figs. 5 and 6, ¶s 4, 5, 10, and 15).
Gnos is silent to a plurality of longitudinal splines generally extending in a direction of the longitudinal axis, the plurality of splines forming a plurality of longitudinal crests and a plurality of longitudinal valleys on the crown of the screw. As to claim 3, Gnos is silent to the plurality of longitudinal valleys are formed by recesses in the crown.
Orbay teaches a similar system (700, plate 702 of ¶55, Figs. 7, and 10-11B, ¶55) capable of affixing to a bone (abstract), the system comprising: a substantially rigid orthopedic component (plate of ¶55, ¶55) having a hole (134, 138, Figs. 7 and 10, ¶55) with a diameter (Figs. 7 and 10), the hole comprising an entry side (Figs. 7 and 10) and an exit side (Figs. 7 and 10), the entry side of the hole comprising an internal helical thread (Figs. 7 and 10, ¶55); a screw (700) having a longitudinal axis (vertical as shown in Fig. 11A), a leading end (Fig. 11A), a trailing end (Fig. 11A), and a cylindrical shaft (704) extending therebetween (Fig. 11A), the trailing end of the screw comprising a head (702, Figs. 11A and 11B, ¶55) having a convex base (Fig. 11A) and a convex crown (Fig. 11A); the crown comprising a screw socket (708) capable of accepting torque from a driver tool (Fig. 11B, ¶56), and a plurality of longitudinal splines (706, 707, Fig. 11A) generally extending in the direction of the longitudinal axis (Fig. 11A), the plurality of splines forming a plurality of longitudinal crests (706, Fig. 11A, ¶55) and a plurality of longitudinal valleys (707, Fig. 11A, ¶55) on the crown of the screw (Fig. 11A, ¶55); the internal helical thread defining a substantially circular contact edge (Figs. 7 and 10, ¶55) capable of impinging on the plurality of longitudinal crests on the head of the screw when the head is inserted in the hole (¶55); wherein the contact edge of the locking cap defines a substantially circular contact path (Figs. 7 and 10, ¶55) on the plurality of longitudinal crests when the head is inserted and tightened into the hole (¶55). As to claim 3, Orbay teaches that the plurality of longitudinal valleys are formed by recesses in the crown (figs. 11A and 11B, ¶55).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the screw head as disclosed by Gnos to have a plurality of longitudinal crests and a plurality of longitudinal valleys as taught by Orbay in order to provide a known screw head shape (Orbay Figs. 11A-12) for deformably engaging a substantially circular contact edge/path (Gnos Fig. 6, ¶s 4 and 5; Orbay ¶55) that allows the screw to be secured/positively locked at an arbitrary angle within a range with respect to the axis of the given screw hole (Gnos ¶5; Orbay ¶55).
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Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gnos and Orbay in view of Castaneda et al. (US 2009/0088807, hereinafter “Castaneda”).
As to claim 8, the combination of Gnos and Orbay discloses the invention of claim 1 as well as the substantially circular contact edge/path (Gnos Fig. 6, ¶s 4 and 5; Orbay ¶55) capable of cutting into or deforming the crown of the head of the screw when the locking cap is tightened against the head of the screw (Figs. 5 and 6, ¶s 4, 5, 10, and 15); wherein the locking cap is harder than the head of the bone screw (Gnos ¶5).
The combination of Gnos and Orbay is silent to specific hardness values for the locking cap and orthopedic component, i.e. the locking cap has a hardness between 35 and 42 HRC; and the orthopedic component has a hardness between 20 and 25 HRC.
Castaneda teaches a similar system (Figs. 1-5) capable of affixing to a bone (abstract), the system comprising: a substantially rigid orthopedic component (12) having a hole (14) with a diameter (Figs. 1 and 3), the hole comprising an entry side (upper side as shown in Figs. 1 and 3, Figs. 1 and 3) and an exit side (lower side as shown in Figs. 1 and 3, Figs. 1 and 3), the entry side of the hole comprising an internal engagement (20, Figs. 1 and 3), the exit side of the hole comprising an internal concave base (Fig. 1); a screw (18) having a longitudinal axis (Figs. 1 and 2), a leading end (Figs. 1 and 2), a trailing end (Figs. 1 and 2), and a cylindrical shaft (Figs. 1 and 2) extending therebetween (Figs. 1 and 2), the trailing end of the screw comprising a head (32), the cylindrical shaft comprising an external helical thread (42, Figs. 1 and 2) capable of engaging said bone (26) and having a shaft diameter smaller than the hole diameter (Fig. 1); the head comprising a screw socket (46) capable of accepting torque from a driver tool (Figs. 1 and 2, ¶26); a locking member (16) comprising a proximal end (Figs. 1 and 4), a distal end (Figs. 1 and 4), and a body (Figs. 1 and 4) extending therebetween (Figs. 1 and 4), the body comprising an external plate engagement (36, Figs. 1 and 3, ¶s 22, 23, and 28) capable of engaging the internal helical thread of the hole (Fig. 1, ¶28); wherein the locking member comprises a cobalt chrome alloy (¶s 10 and 25) and has a hardness between 35 and 42 HRC (¶s 10 and 25 discloses 36-44 HRC); and the orthopedic component comprises a titanium alloy (¶s 9 and 19) and has a hardness between 28 and 35 HRC (¶s 9 and 19).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to specify that the locking cap and orthopedic component as disclosed by the combination of Gnos and Orbay comprises a cobalt chrome alloy and a titanium alloy, respectively, as taught by Castaneda in order to select a known biocompatible material (Castaneda ¶s 9, 10, 19, and 25) with a harder locking member than the orthopedic component (Castaneda ¶s 9, 10, 19, and 25) to provide the ability to penetrate the plate (Castaneda ¶25) to increase the frictional engagement (Castaneda ¶28) and lock the screw at the desired angle (Gnos ¶5; Castaneda ¶28). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the cobalt chrome alloy locking cap and titanium alloy orthopedic component of the combination of Gnos, Orbay, and Castaneda have a hardness between 36 and 42 HRC and a hardness between 20 and 25 HRC, respectively, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the device of the combination of Gnos, Orbay, and Castaneda would not operate differently with the cobalt chrome alloy locking cap hardness between 36 and 42 HRC and the titanium alloy hardness between 20 and 25 HRC to provide the locking member/cap with a material that is considerably harder than the orthopedic component (Castaneda abstract) to predictably lock the screw at the desired angle (Gnos ¶5; Castaneda ¶28). Further, Applicant places no criticality on the hardness ranges claimed, indicating simply that the value “may optionally” be or “has” a value within the claimed ranges (paragraphs 13 and 53).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see the attached PTO-892, Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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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
Prosecution Insights