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 Arguments
Applicant’s arguments, see Remarks, filed 03/13/2026, with respect to the rejection of claims 10 and 20 under 112(a) have been fully considered and are persuasive. The rejections of claims 10 and 20 has been withdrawn.
Regarding the arguments directed to claims 2 – 10 and 12 – 20, applicant argues that from the context of the specification and claims of the present application, one of skill in the art is provided with sufficient certainty as to the ranges encompassed by the term “about”. The Office respectfully disagrees. The specification and claims provide no specific standards to interpret context, such as references to ISO and ASTM standards. Any variation in the screw thread characteristics directly impacts the mechanical performance of the device and are therefore crucial to the understanding of the claimed invention. One of ordinary skill would not be able to ascertain the metes and bounds of the claims without clear, objective criteria such as +/- 5% or 10% or 0.1%. Therefore, the rejection is maintained and for purposes of examination a +/- 10% of the stated value/range will be applied.
Regarding the rejections under 35 USC § 103, applicant argues that there is no recognition in the prior art that the thread depth to base ratio could be tailored to provide a secure grip on bone and /or a tighter fit to enhance screw stability and reduce the risk of loosening. The Office respectfully disagrees. The rational is not speculative or hindsight, but relies upon knowledge in the field. Please see attached publication “Factors Affecting the Pullout Strength of Cancellous Bone Screws” as supporting evidence. In addition, optimization of known parameters is applicable because bone screw design is a trade-off of well-known parameters such as inner and outer diameters, pitch and profiles. Varying these parameters for improved performance would be obvious to a person of ordinary skill in the art.
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 2 – 10 and 12 – 20 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.
The term “about” in claims 2 – 10 and 12 – 20 is a relative term which renders the claim indefinite. The term “about” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For purposes of examination the term “about” will be taken to mean a +/- 10% of the value claimed.
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 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.
Claim(s) 2 – 4, 10 – 14, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham et al. (US 2017/0209183 A1).
Regarding claim 2, Wickham discloses a bone screw (Abstract) comprising:
a head (Fig. 3, ref. 14); and
a threaded shaft extending from the head (Fig. 3, ref. 16), the threaded shaft having at least one thread defining a thread depth (the thread depth is defined as D minus D2) and a base width (the base width is taken to be the thread width at the root of the shaft or at D2), but is silent that a thread-depth-to-base-width ratio is greater than about 5.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the screw to have a thread depth to base ratio to be greater than 5 to provide a secure grip on bone via the smaller base width which would allow for a tighter fit which can enhance the screw’s stability and reduce the risk of loosening (see Response to Arguments above) and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 3, Wickham discloses the bone screw according to claim 2, wherein the threaded shaft defines a length-to-major diameter ratio of less than about 2.0 (Fig. 10 shows several ratios less than about 2.0, such as a length of 5 mm and a diameter of 4 mm which results in a ratio of 1.3).
Regarding claim 4, Wickham discloses the bone screw according to claim 3, wherein the threaded shaft defines a length of from about 5 mm to about 10 mm (Fig. 10).
Regarding claim 10, Wickham discloses the bone screw according to claim 2, except wherein the thread-depth-to-base width ratio is less than about 11.67. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the screw to have a thread depth to base ratio to be less than about 11.67 to provide a secure grip on bone via the smaller base width which would allow for a tighter fit which can enhance the screw’s stability and reduce the risk of loosening and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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Regarding claim 11, Wickham discloses the bone screw according to claim 2, wherein the thread defines at least one of: a leading-edge angle and a trailing edge angle (see remarked Fig. 5 below), but is silent regarding specific numerical values of the leading-edge angle from -4.0 degrees to 15 degrees or a trailing edge angle of from -4.0 degrees to 15 degrees. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the screw to have the leading-edge angle from -4.0 degrees to 15 degrees or a trailing edge angle of from -4.0 degrees to 15 degrees to balance high anchorage ad low insertion torque and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 12, Wickham discloses a bone screw (Abstract), comprising:
a receiver (Fig. 6, ref. 50);
a head (Fig. 5, ref. 14) at least partially disposed within the receiver (Fig. 6) and configured to angulate in at least one direction relative to the receiver (paragraph [0046]); and
a threaded shaft (ref. 16) extending from the head (Figs. 1 – 5), the threaded shaft having at least one thread defining a thread depth (D minus D2 as shown in Fig. 3), a base (considered to be the width of the thread at the root or at D2), and a tip (distal most end of the thread), but is silent that a thread-depth-to-base width ratio is greater than about 5. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the screw to have a thread depth to base ratio to be greater than 5 to provide a secure grip on bone via the smaller base width which would allow for a tighter fit which can enhance the screw’s stability and reduce the risk of loosening and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 13, Wickham discloses the bone screw according to claim 12, wherein the threaded shaft defines a length-to-major diameter ratio of less than about 2.0 (Fig. 10 shows several ratios less than about 2.0, such as a length of 5 mm and a diameter of 4 mm which results in a ratio of 1.3).
Regarding claim 14, Wickham discloses the bone screw according to claim 13, wherein the threaded shaft defines a length of from about 5 mm to about 10 mm (Fig. 10).
Regarding claim 20, Wickham discloses the bone screw according to claim 12, except wherein the thread-depth-to-base width ratio is less than about 11.67. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the screw to have a thread depth to base ratio to be less than about 11.67 to provide a secure grip on bone via the smaller base width which would allow for a tighter fit which can enhance the screw’s stability and reduce the risk of loosening and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 21, Wickham discloses the bone screw according to claim 12, wherein the thread defines at least one of: a leading-edge angle and a trailing edge angle (see remarked Fig. 5 above), but is silent that the angles are from -4.0 degrees to 15 degrees. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to construct the screw to have the leading-edge angle from -4.0 degrees to 15 degrees or a trailing edge angle of from -4.0 degrees to 15 degrees to balance high anchorage ad low insertion torque and since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claim(s) 5, 6, 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham et al. (US 2017/0209183 A1) in view of Ralph et al. (US 2010/0131012 A1).
Regarding claim 5, Wickham discloses the bone screw according to claim 2, except wherein the threaded shaft defines a major-diameter-to-minor diameter ratio of greater than about 2.0.
Regarding claim 15, Wickham discloses the bone screw according to claim 12, except wherein the threaded shaft defines a major-diameter-to-minor diameter ratio of greater than about 2.0.
Ralph teaches a bone screw (Fig. 12) having threading with a major and minor diameter (Fig. 12, refs. D1, D2) and a major to minor ratio of 1.5 to 2.0 (paragraph [0045], please note that “about 2.0” falls within this range). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the diameters of Wickham to have a ratio of greater than about 2.0, as taught by Ralph, for the purpose of greater purchasing power in the bone tissue.
Regarding claim 6, Wickham in view of Ralph discloses the bone screw according to claim 5, wherein the threaded shaft defines a major diameter of from about 4.5 mm to about 8 mm (Wickham, Fig. 10).
Regarding claim 16, Wickham discloses the bone screw according to claim 15, wherein the threaded shaft defines a major diameter of from about 4.5 mm to about 8 mm (Fig. 10).
Claim(s) 7 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham et al. (US 2017/0209183 A1) in view of Jackson et al. (US 2014/0142633 A1).
Regarding claim 7, Wickham discloses the bone screw according to claim 2, except wherein the at least one thread includes a pitch of greater than about 1.0 mm.
Regarding claim 17, Wickham discloses the bone screw according to claim 12, except wherein the at least one thread includes a pitch of greater than about 1.0 mm.
Jackson teaches a bone screw (Abstract) having a pitch greater than about 1.0 mm (paragraph [0047] discloses a range, for example 0.129 inches which is about 3 mm). Jackson teaches that the bone screw performs better under torque with such ranges (paragraph [0047]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pitch of Wickham to have a value of greater than about 1.0 mm, as taught by Jackson, for the purpose of better performing under high torques.
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham et al. (US 2017/0209183 A1) in view of Moumene et al. (US 2004/0243129 A1).
Regarding claim 8, Wickham discloses the bone screw according to claim 2, except wherein the at least one thread defines a tip width in a range of about 0.075 mm to about 0.400 mm.
Regarding claim 18, Wickham discloses the bone screw according to claim 12, except wherein the at least one thread defines a tip width in a range of about 0.075 mm to about 0.400 mm.
Moumene teaches a bone screw (Abstract) comprising a thread defining a tip width in a range of about 0.075 mm to about 0.400 mm (paragraph [0028] discloses a range of about 0.15 mm to 0.30 mm which overlaps with the claimed range). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the tip width of Wickham such that it is in a range of about 0.075 mm to about 0.400 mm, as taught by Moumene, for the purpose of concentrating a bearing load on a smaller area and acting as a sharp edge to better displace bone tissue.
Claim(s) 9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wickham et al. (US 2017/0209183 A1) in view of Poulos (US 2014/0277188 A1).
Regarding claim 9, Wickham discloses the bone screw according to claim 2, except wherein the thread depth is from about 0.75 mm to about 3.50 mm.
Regarding claim 19, Wickham discloses the bone screw according to claim 12, except wherein the thread depth is from about 0.75 mm to about 3.50 mm.
Poulos detaches a bone screw (Abstract) having a thread depth from about 0.75 mm to about 3.50 mm (paragraph [0043] discloses a thread depth of about 0.95 mm which is within the claimed range). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thread depth of Wickham to be from about 0.75 mm to about 3.50 mm, as taught by Poulos, for the purpose of balancing insertion torque and stripping risk.
Conclusion
THIS ACTION IS MADE FINAL. 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
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