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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 22 September 2025. As directed by the amendment: claims 1, 3-7, and 9 have been amended, and claims 10-18 stand withdrawn. Claims 1-18 currently stand pending in the application.
The amendments to the claims are not sufficient to overcome the claim objections listed in the previous action, which are repeated below in relevant part.
Response to Arguments
Applicant's arguments filed 22 September 2025 with respect to the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive.
As to Reitblat et al. (US 2017/0164985), Applicant contends that Reitblat does not disclose or suggest that inner sides of portions of the two side walls that face each other each include a threading, since FIG. 18 of Reitblat discloses one threaded portion 500. Examiner respectfully submits that, although Reitblat refers to previous embodiments to describe interaction with an externally threaded blocker, the embodiment of FIG. 18 differs from previous embodiments in that the embodiment of FIG. 18 is utilized when both blades have been removed and the side walls of the gripping member 312’ are the only components gripping the pedicle screw head (par. [0091] describes FIG. 18 is largely similar to FIGS. 13 and 15, and par. [0085] describes the use in FIGS. 11-16B and 17A-D when both blades have been removed). Applicant refers to FIGS. 6B and 8B which show an embodiment in which only one blade has been removed, and the internal threads 58 are provided on the one remaining blade 52 (par. [0063]) and not on side walls of a retractor/gripping member which is inserted over the blade. Therefore, there is a lack of equivalence between the embodiment shown in FIGS. 6B and 8B, to which Applicant refers to show that internal threading is on only one side, and the embodiment shown in FIG. 18 and referred to in the rejection, where there are no blades remaining (and therefore no single blade remaining that provides threads on only one side) and the internal threading is provided on the side walls of the gripping member. Although Reitblat does not specifically show that there is threading on each of the two side walls (324’, 326’), since the inner side of only one side wall is shown in FIG. 18, Reitblat also does not teach away from having threading on each side wall, since the embodiment of FIG. 18 is utilized when both blades have been removed and the side walls are the only components gripping the pedicle screw head. Assuming arguendo, the following rejection duplicates the threading 500 so that there is threading on each of the two side walls.
Examiner further notes that the claim does not require threading on each of the two side walls. Rather, claim 1 can be interpreted that one of the two side walls has portions (e.g. proximal and distal portions of the threaded section on one side wall) that each include a threading (since the portions each include a proximal or distal part/section of the threading) on their inner side. The two side walls face each other, i.e. the claim does not require the portions to face each other (this term modifies the two side walls) and therefore the portions may be on the same side wall. The claim does not require that each of the two side walls has a portion, but only that portions of the two side walls (the portions in this interpretation being on one of the side walls) include threading. Inner sides of portions of each of the two side walls include a threading is different than inner sides of portions of the two side walls each include a threading.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As to Biedermann et al. (US 7,879,036), Applicant contends that Biedermann does not disclose or suggest that inner sides of portions of the two side walls that face each other include a threading, since Biedermann’s barb elements are located externally on one single external surface. Examiner respectfully submits that Biedermann is relied upon as a teaching of biased flanks that can be arranged in a helical line (deployed) or can be biased in line with the side wall (collapsed). As applied to Reitblat, the threading would be arranged so as to protrude inwardly so as to engage the threaded blocker as required by Reitblat.
Applicant further contends that one skilled in the art would not have been led to modify Reitblat in view of Biedermann. Applicant contends that the flanks/tabs in Biedermann are arranged in a helical line to provide screw threading into the bone by cutting into and removal of the bone material both during insertion and removal of the screw, and therefore there is no fine tuning adjustment because the cutting edge of the flanks/tabs continually cut away bone material every time the screw is rotated. Examiner respectfully submits that Biedermann teaches that “[[t]]he barb elements provide for a thread-like function, which allows to correct the position of the bone anchoring element in the core hole after inserting it into the core hole, by either positioning it deeper into the bone by means of a screwing-inwards motion or by screwing it backwards.” (col. 2 / lines 6-11). Biedermann is thus relied upon as a teaching of flanks/tabs arranged in a helical line to provide the benefits of screw threading, or movement in a thread-like function.
Applicant contends that modifying Reitblat for rapid insertion of the blocker would render Reitblat unsatisfactory for its intended purposes, since modifying Reitblat in the manner suggested by the Office would result in the blocker being positioned immediately at the screw head inner thread and not in the correct starting position and with the risk of cross-threading occurring in the screw head. The device of Reitblat is configured with threading on the arm above the screw head to avoid this from happening. Examiner respectfully submits that this is mere conjecture. Reitblat contemplates embodiments having no interior threading (FIG. 13B), and even when Reitblat contemplates threading, it is recited that the interior surface “may” include a threaded portion, allowing for the possibility that there is no threaded portion, and therefore establishing that there are not significant risks associated with no threaded portion. The start of threading a blocker into an internally threaded portion would encounter the same risk of cross-threading if the blocker is introduced first into threads in the side walls or first into threads in the screw head; i.e. accidentally cross-threading the blocker into a threaded side wall portion would yield a similarly increased surgical time as if this cross-threading occurred in the screw head.
Simply removing the threading would provide rapid insertion but would lack the benefit of fine tuning rotational adjustment as guided by screw threading and contemplated by Biedermann.
The simple substitution of one thread type for another is motivated by the above reasons, including that the tabs taught in Biedermann are able to be arranged in a helical line to provide the benefits of screw threading, while also able to be biased in line with the side wall for rapid insertion of the blocker to save surgical time. Biedermann’s tabs provide flexibility in application.
As to Stokes et al. (US 2018/0256212), Applicant contends that Stokes does not disclose or suggest that inner sides of portions of the two side walls that face each other each include a threading. Applicant contends that only the arm 202 is shown to have an inner threading. Examiner respectfully submits that Stokes discloses portions of the first and second sidewalls are threaded (par. [0047]). Although threads are only visible on arm 202 in the perspective of FIG. 2A, there appears to be a corresponding thickness on arm 203, and another embodiment shown in FIGS. 4A-4C show threads on both arms 402 and 403.
The arguments as to Biedermann are addressed as above.
Claim Objections
Claim 4 is objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 4 / line 2: “[[the]] a proximal side of each side wall”
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2017/0164985 to Reitblat et al. (hereinafter, “Reitblat”), in view of U.S. Patent No. US 7,879,036 to Biedermann et al. (hereinafter, “Biedermann”).
As to claim 1, Reitblat discloses a screw extender, FIG. 18, for an implant system having a distal side for holding a screw and a proximal side, the screw extender comprising: two side walls (324’, 326’) facing each other and connected to each other (par. [0091]), FIG. 18; wherein inner sides of portions of the two side walls that face each other each include a threading (500) (inner/inwardly facing sides of portions, e.g. proximal and distal portions of the threaded section of 324’ shown in FIG. 18, each include threading, where the portions are of the two side walls – of one side wall of the two side walls – and the two side walls face each other), and wherein the threading includes a plurality of flanks, each flank including a tab that is bent inwardly towards the other side wall (where the term “bent” is commonly understood to mean having an angle; each thread portion is a tab that is bent inwardly towards the other side wall because it is at an angle pointing toward the other side wall).
As to claim 5, Reitblat discloses the screw extender of claim 1, wherein the two side walls are connected to each other at the proximal side by a connection element (horizontal portion connecting 324’ and 326’), the two side walls and the connection element are formed from one strip of material (where a strip is a long narrow piece; since the side walls and the connection element are elongate and monolithic, they are formed from one strip or long narrow piece of material), the strip of material bent (having an angle, as defined above) at two locations (where the connection element meets each side wall) by ninety degrees, the connection element located between the two bent locations. The claimed phrases “formed from one strip of material” and “bent at two locations by ninety degrees” are being treated as product by process limitations. 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 (in this case, monolithically formed side walls and connection element – one strip – which are at an angle to each other – bent), 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 claim 6, Reitblat discloses the screw extender of claim 1, wherein the two side walls and a connection element are separate elements (where “separate” is commonly understood to mean distinct; the side walls and the connection element are separate or distinct since they are distinguishable from each other due to their different axes and shapes) that are connected to each other (integrally) to form a U-shape, FIG. 18.
As to claim 8, Reitblat discloses the screw extender of claim 1, wherein at least the inner sides of the portions of the two side walls with the threading are bent to form an arcuate shape when viewed in a direction of an axis of longitudinal extension of the two side walls, FIG. 18.
Reitblat is silent as to a wall-traversing opening in the corresponding side wall delineating the flank (claim 1); wherein the wall-traversing opening forms a U-shape around the bent tab (claim 2).
Biedermann teaches a threading including a plurality of flanks, each flank including a bent tab and a wall-traversing opening in a side wall delineating the flank, FIGS. 1 and 3; wherein the wall-traversing opening forms a U-shape around the bent tab, FIG. 1.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Reitblat’s threading to include a plurality of flanks each including a tab that is delineated by a wall-traversing opening, such that the tabs are bent inwardly towards the other side wall as required by Reitblat, i.e. the tabs bend away from the inner surface of the side walls, since Biedermann teaches that such flanks/tabs can be arranged in a helical line to provide the benefits of screw threading, i.e. fine tuning adjustment of complementarily threaded parts, while also allowing rapid insertion of one part relative to another when the flanks/tabs are biased in line with the side wall. In the application of Reitblat, the flanks/tabs can be biased in line with the side wall for rapid insertion of the blocker (the free end of the flanks/tabs would be directed distally) to save surgical time, and when the flanks/tabs spring back out away from the side wall and towards the other side wall they can allow for fine tuning rotational adjustment of the threaded blocker along the threads created by the helically arranged flanks/tabs, as well as removal of the blocker by reverse rotation. The simple substitution of one known element for another (one type of thread for another) to obtain predictable results (threaded interaction) is within the ordinary skill in the art.
Assuming arguendo, Reitblat is silent as to wherein inner sides of portions of the two side walls that face each other each include a threading.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide threading on inner sides of portions of each of the two side walls that face each other, since the mere duplication of the essential working parts of a device involves only routine skill in the art. Although Reitblat does not specifically show that there is threading on each of the two side walls (324’, 326’), since the inner side of only one side wall is shown in FIG. 18, Reitblat also does not teach away from having threading on each side wall, since the embodiment of FIG. 18 is utilized, similar to previous embodiments, when both blades have been removed and the side walls are the only components gripping the pedicle screw head. Providing threading (complementarily arranged, so that a continuous thread extends along both side walls) on each of the two side walls for threaded interaction with the threaded blocker would ensure that the blocker remains aligned within the space between the side walls and does not slip lower on an unthreaded side wall.
As to claim 3, Reitblat discloses wherein a distal side of each side wall includes a first engagement mechanism (330) for holding a pedicle screw (labelled and described with respect to FIG. 17C, par. [0072]), the first engagement mechanism formed by at least one protruding ridge (protrudes outwardly from a rest of the side wall) and a slit-shaped wall-traversing opening (332’), FIG. 18.
As to claim 7, Reitblat discloses wherein the at least one protruding ridge of the first engagement mechanism is arranged to be parallel (along its longitudinal length) to an axis of longitudinal extension of the two side walls.
Reitblat is silent as to a slit-shaped wall-traversing opening on each side of the ridge.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify each side wall of Reitblat to divide into three distal prongs (333) since the mere duplication of the essential working parts of a device involves only routine skill in the art, and having more prongs would allow the side walls to better conform to the pedicle screw they are gripping. Then, the middle of the three prongs would have a slit-shaped wall-traversing opening on each side of the ridge of the prong.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Reitblat in view of Biedermann (hereinafter, “Reitblat/Biedermann”), as applied to claims 1-3 and 5-8 above, and further in view of U.S. Patent No. US 7,491,208 to Pond, Jr. et al. (hereinafter, “Pond”).
As to claim 9, Reitblat/Biedermann are silent as to wherein at least one of the two side walls includes a bent fold along a long side of the corresponding side wall, the bent fold bent along a bending line that is parallel to a longitudinal axis of extension of the screw extender to stiffen the screw extender.
As to claim 1, Pond teaches a screw extender for an implant system having a distal side for holding a screw and a proximal side, FIG. 7, the screw extender comprising: two side walls (20) facing each other and connected to each other.
As to claim 9, Pond teaches wherein at least one of the two side walls includes a bent fold (where 22 transitions into angled side portions 46) along a long side of the corresponding side wall, the bent fold bent along a bending line that is parallel to a longitudinal axis of extension of the screw extender to stiffen the screw extender (fully capable of stiffening the screw extender at least at its distal end).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the outer edges of the side walls of Reitblat/Biedermann with a bent fold along an external long side of the side wall, the bent fold bent along a bending line that is parallel to a longitudinal axis of extension, to create angled side portions that can grip around the edges of the pedicle screw head, as taught by Pond, for greater attachment security. Reitblat contemplates tabs (344a) that grip the pedicle screw, but providing the angled side portions as a bent side or end of the side wall would provide greater gripping area and compatibility with a different type of pedicle screw such as taught by Pond. As above, the phrase “bent fold bent along a bending line” is being treated as a product by process limitation and does not require the angled side portions to be formed by bending, since the resultant structure (two sections at an angle to each other) is taught by Pond.
Claims 1-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2018/0256212 to Stokes et al. (hereinafter, “Stokes”), in view of Biedermann.
As to claim 1, Stokes discloses a screw extender, FIGS. 2A-2J, for an implant system having a distal side for holding a screw, FIG. 2A, and a proximal side, the screw extender comprising: two side walls (202, 203) facing each other and connected to each other; wherein inner sides of portions of the two side walls that face each other each include a threading (par. [0047]), FIG. 2A, and wherein the threading includes a plurality of flanks, each flank including a tab that is bent inwardly towards the other side wall (where the term “bent” is commonly understood to mean having an angle; each thread portion is a tab that is bent inwardly towards the other side wall because it is at an angle pointing toward the other side wall).
As to claim 3, Stokes discloses the screw extender of claim 1, wherein a distal side of each side wall includes a first engagement mechanism (portion of 207 adjacent each distal side of each wall) for holding a pedicle screw, FIG. 2A, the first engagement mechanism formed by at least one protruding ridge (horizontal ridge on proximal end of 207) and a slit-shaped wall-traversing opening on each side of the ridge (since the ridge is formed by a slit-shaped opening on each side that traverses or travels across or at least partially through the wall).
As to claim 4, Stokes discloses the screw extender of claim 1, wherein the proximal side of each side wall includes a second engagement mechanism (220, 230) for holding a handle (210; where a handle is commonly understood as being a graspable part), FIG. 2C, the second engagement mechanism formed by at least one protruding ridge and a slit-shaped wall-traversing opening formed on each side of the ridge (slit-shaped openings extending along or traversing across and through the wall, on each side of and defining the ridge forming the mechanism 220, 230), FIG. 2C.
As to claim 5, in another interpretation, Stokes discloses the screw extender of claim 1, wherein the two side walls are connected to each other at the proximal side by a connection element (210), FIG. 2C, the two side walls and the connection element are formed from one strip of material (where a strip is a long narrow piece; since the side walls and the connection element are elongate and monolithic, they are formed from one strip or long narrow piece of material), the strip of material bent (having an angle, as defined above) at two locations (where the connection element meets each side wall, or where the connection element 210 extends downward to 220/230) by ninety degrees, the connection element located between the two bent locations. The claimed phrases “formed from one strip of material” and “bent at two locations by ninety degrees” are being treated as product by process limitations. 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 (in this case, monolithically formed side walls and connection element – one strip – which are at an angle to each other – bent), 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 claim 6, in another interpretation, Stokes discloses the screw extender of claim 1, wherein the two side walls and a connection element are separate elements (where “separate” is commonly understood to mean distinct; the side walls and the connection element are separate or distinct since they are distinguishable from each other due to their different axes and shapes) that are connected to each other to form a U-shape, FIG. 2B.
As to claim 8, Stokes discloses the screw extender of claim 1, wherein at least the inner sides of the portions of the two side walls with the threading are bent to form an arcuate shape when viewed in a direction of an axis of longitudinal extension of the two side walls, FIG. 2A.
Stokes is silent as to a wall-traversing opening in the corresponding side wall delineating the flank (claim 1); wherein the wall-traversing opening forms a U-shape around the bent tab (claim 2).
Biedermann teaches a threading including a plurality of flanks, each flank including a bent tab and a wall-traversing opening in a side wall delineating the flank, FIGS. 1 and 3; wherein the wall-traversing opening forms a U-shape around the bent tab, FIG. 1.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Stokes’ threading to include a plurality of flanks each including a tab that is delineated by a wall-traversing opening, such that the tabs are bent inwardly towards the other side wall as required by Stokes, i.e. the tabs bend away from the inner surface of the side walls, since Biedermann teaches that such flanks/tabs can be arranged in a helical line to provide the benefits of screw threading, i.e. fine tuning adjustment of complementarily threaded parts, while also allowing rapid insertion of one part relative to another when the flanks/tabs are biased in line with the side wall. In the application of Stokes, the flanks/tabs can be biased in line with the side wall for rapid insertion of a blocker (the free end of the flanks/tabs would be directed distally) to save surgical time, and when the flanks/tabs spring back out away from the side wall and towards the other side wall they can allow for fine tuning rotational adjustment of the threaded blocker along the threads created by the helically arranged flanks/tabs, as well as removal of the blocker by reverse rotation. The simple substitution of one known element for another (one type of thread for another) to obtain predictable results (threaded interaction) is within the ordinary skill in the art.
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 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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775