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 .
Election/Restrictions
Applicant's election with traverse of Species B (Figs. 9-14) in the reply filed on June 18, 2025 is acknowledged.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 21-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Janna et al. (US 2024/0261009; “Janna”).
Claim 21, Janna discloses an orthopedic screw (Fig. 2B) having a longitudinal axis (Fig. 2B; axis running lengthwise through the screw), comprising: a head portion (140) defining a proximal end (140) and having a first outer diameter (diameter of the head), a tip portion (110) defining a cutting edge (112) and a distal end (110), a body (120) extending between the proximal end and the distal end along the longitudinal axis (Fig. 2B) and defining a shaft (120) having a second outer diameter (diameter of the shaft) that is less than the first outer diameter (Fig. 2B), and a neck portion (130) defining a taper (Fig. 2B; paragraph [0040]) extending between the first outer diameter and the second outer diameter (Fig. 2B; paragraph [0040]) and having an outer surface (Fig. 2B; where 130 points) that defines first and second cutting flutes (Fig. 2B; 170; paragraph [0041]) that cooperatively define a cutting surface, a cutting relief, and a material removal channel (Fig. 2B; paragraph [0041]); wherein the proximal end defines a proximal opening (Fig. 2C; 142) creating a cavity (142), the head portion defining a cavity (Fig. 2C; where 142 points) bounded by a circumferential wall (wall that 142 points towards) and a transverse wall (Fig. 2C; the lower transverse shoulder and wall just below the circumferential wall and above what looks like internal threads).
Claim 22, Janna discloses the orthopedic screw of claim 21, wherein the head portion defines a continuous circumferential flange (Fig. 2A; flange just proximal where 146 and 148 point) that forms the proximal end (Fig. 2A).
Claim 23, Janna discloses the orthopedic screw of claim 21, wherein the proximal end has a third outer diameter (Fig. 2A; diameter measured near where 148 points) that is different from the first outer diameter and the second outer diameter (Fig. 2A); and wherein the third outer diameter is less than the first outer diameter and greater than the second outer diameter (Fig. 2A).
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.
Claim(s) 31-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Janna et al. (US 2024/0261009; “Janna”), in view of Wapner et al. (US 2019/0321087; “Wapner”).
Claim 31, Janna discloses an orthopedic screw (Fig. 2B) having a longitudinal axis (Fig. 2B; axis running lengthwise through the screw), comprising: a head portion (140) defining a proximal end (140) and having a first outer diameter (diameter of the head), a tip portion (110) defining a cutting edge (112) and a distal end (110), a body (120) extending between the proximal end and the distal end along the longitudinal axis (Fig. 2B) and defining a shaft (120) having a second outer diameter (diameter of the shaft) that is less than the first outer diameter (Fig. 2B), and a neck portion (130) defining a taper (Fig. 2B; paragraph [0040]) extending between the first outer diameter and the second outer diameter (Fig. 2B; paragraph [0040]) and having an outer surface (Fig. 2B; where 130 points) that defines first and second cutting flutes (Fig. 2B; 170; paragraph [0041]) that cooperatively define a cutting surface, a cutting relief, and a material removal channel (Fig. 2B; paragraph [0041]); wherein the proximal end defines a proximal opening (Fig. 2C; 142) creating a cavity (142) the head portion defining a cavity (Fig. 2C; where 142 points) bounded by a circumferential wall (wall that 142 points towards) and a transverse wall (Fig. 2C; the lower transverse shoulder and wall just below the circumferential wall and above what looks like internal threads).
However, Janna does not disclose the screw having an inner core member and an outer body member as required by the claim.
Wapner teaches an orthopedic screw (Fig. 1) comprising a metal inner core member defining the tip portion and the circumferential wall; and a polymeric outer body member disposed circumferentially around the inner core member and comprising the body (paragraph [0053]; Applicant has directly copied this paragraph into their application, see paragraph [0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the screw of Janna, to have the inner core and outer body, as taught by Wapner, because this combination of materials provides desirable characteristics and a favorable balance between manufacturability and strength considerations. In these embodiments, the outer body member can be made of any material suitable for use in medical devices intended for orthopedic use, including use as a long-term implant (paragraph [0053]).
Claim 32, Janna in view of Wapner disclose the orthopedic screw of claim 31, Janna discloses wherein the head portion defines a continuous circumferential flange (Fig. 2A; flange just proximal where 146 and 148 point) that forms the proximal end (Fig. 2A).
Claim 33, Janna in view of Wapner disclose the orthopedic screw of claim 32, Janna discloses wherein the proximal end has a third outer diameter (Fig. 2A; diameter measured near where 148 points) that is different from the first outer diameter and the second outer diameter (Fig. 2A); and wherein the third outer diameter is less than the first outer diameter and greater than the second outer diameter (Fig. 2A).
Claim 34, Janna in view of Wapner disclose the orthopedic screw of claim 33, Wapner teaches wherein the metal inner core member comprises a Titanium alloy (paragraph [0053]).
Claim 35, Janna in view of Wapner disclose the orthopedic screw of claim 34, Wapner teaches wherein the polymeric outer body member comprises a carbon fiber reinforced polymer (paragraph [0053]).
Claim 36, Janna in view of Wapner disclose the orthopedic screw of claim 35, Wapner teaches wherein the polymeric outer body member comprises carbon fiber reinforced polyether ether ketone (paragraph [0053]).
Claim 37, Janna discloses an orthopedic screw (Fig. 2A) having a proximal end (140), a distal end (110), and a longitudinal axis (axis of the screw) extending between the proximal end and the distal end (Fig. 2A), the orthopedic screw comprising: a head (140) portion having a first outer diameter (diameter measured near where 148 points); a body (120) extending between the proximal end and the distal end along the longitudinal axis (Fig. 2A) and defining a shaft (120) having a second outer diameter (diameter measured near where 160 points) that is less than the first outer diameter (Fig. 2A); and a neck portion (130) defining a taper (Fig. 2A; paragraph [0040]) extending between the first outer diameter and the second outer diameter (Fig. 2A; paragraph [0040]) and having an outer surface (Fig. 2B; surface that 130 points towards) that defines first and second cutting flutes (Fig. 2B; 170; paragraph [0041]) that cooperatively define a cutting surface, a cutting relief, and a material removal channel (Fig. 2B; paragraph [0041]).
However, Janna does not disclose the screw having an inner core member and an outer body member as required by the claim.
Wapner teaches an orthopedic screw (Fig. 1) comprising a metal inner core member extending along the longitudinal axis and defining the proximal end and the distal end and a polymeric outer body member disposed circumferentially around the inner core member (paragraph [0053]; Applicant has directly copied this paragraph into their application, see paragraph [0051]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the screw of Janna, to have the inner core and outer body, as taught by Wapner, because this combination of materials provides desirable characteristics and a favorable balance between manufacturability and strength considerations. In these embodiments, the outer body member can be made of any material suitable for use in medical devices intended for orthopedic use, including use as a long-term implant (paragraph [0053]).
Claim 38, Janna in view of Wapner disclose the orthopedic screw of claim 37, Janna discloses wherein the proximal end has a third outer diameter (Fig. 2A; diameter measured near where 148 points) that is different from the first outer diameter and the second outer diameter (Fig. 2A); and wherein the third outer diameter is less than the first outer diameter and greater than the second outer diameter (Fig. 2A).
Claim 39, Janna in view of Wapner disclose the orthopedic screw of claim 38, Wapner teaches wherein the metal inner core member comprises a Titanium alloy (paragraph [0053]).
Claim 40, Janna in view of Wapner disclose the orthopedic screw of claim 39, Wapner teaches wherein the polymeric outer body member comprises a carbon fiber reinforced polymer (paragraph [0053]).
Response to Arguments
In response to Applicant’s argument that Janna fails to disclose “the head portion having a neck portion with a taper…and a material removal channel, the Examiner respectfully disagrees. As pointed out in the previous rejection and the current rejection above, the flute 170 in the tapered neck region 130 teaches all the limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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 Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (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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/Zade Coley/Primary Examiner, Art Unit 3775