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 .
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) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb et al. (US Pub 2004/0204712) in view of Zacouto et al. (US Pub 2002/0151978).
With respect to claim 1, Kolb discloses a construct (see fig 1 and 6 below) comprising: a bone plate (fig 1, 10) with a plurality of through openings (fig 1, 28s) configured to be secured to a bone; a plurality of bone fasteners (fig 6, 25) having a head (see fig 6 below) and a threaded shaft (see fig 6 below and paragraph 44, bone screws) positioned through each of the respective through openings in the bone plate; and a reverse dynamization component (fig 1, 16) configured to, once the construct is secured to the bone, allow for micro-motion of the bone for a period of time and then form a rigid configuration to prevent subsequent movement of the bone (paragraph 41 discloses the plate can be converted from a dynamic plate to a rigid plate, this can be performed in a follow up procedure).
With respect to claim 1, Kolb discloses the claimed invention except for once the period of time has expired changing the construct to a rigid configuration.
Zacouto discloses once the period of time has expired (paragraph 106) changing the construct to a rigid configuration (paragraph 135 change the rigidity during different phases of the bone healing to allow for a theoretically possible or desirable natural movement between the two bone parts to which the anchoring means are fixed (paragraph 135).
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 device of Kolb to include once the period of time has expired automatically changing the construct to a rigid configuration in view of Zacouto in order to allow for a theoretically possible or desirable natural movement between the two bone parts to which the anchoring means are fixed.
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Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb et al. in view of Zacouto as applied to claim 1 above, and further in view of Biedermann er al. (US Pub 2014/0188180).
With respect to claim 3, Kolb in view of Zacouto discloses the claimed invention with discloses the device being converted automatically by changing the rigidity of a damping component (paragraph 135 of Zacouto and does not disclose wherein the reverse dynamization component is formed of a shape-memory material that is activated due to an external stimulation to change from a first state to allow for the micro-motion to a second state when in the rigid configuration.
Biedermann discloses a reverse dynamism component formed of a shape-memory material (paragraph 7) that is activated due to an external stimulation (paragraph 68) to change from a first state to allow for the micro-motion to a second state when in the rigid configuration (paragraph 67 changes between states) to convert the device between a dynamic to rigid configuration (paragraph 8)
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the changing the rigidity of a damping component of Kolb in view of Zacouto with the wherein the reverse dynamization component is formed of a shape-memory material that is activated due to an external stimulation to change from a first state to allow for the micro-motion to a second state when in the rigid configuration in view of Biedermann because a changing the rigidity of a damping component and the reverse dynamization component is formed of a shape-memory material that is activated due to an external stimulation to change from a first state to allow for the micro-motion to a second state when in the rigid configuration are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of converting the device between a dynamic to rigid configuration.
Claim(s) 6 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kolb et al. in view of Zacouto as applied to claim 1 above, and further in view of Boyce et al. (US pub 2007/0233272).
With respect to claim 6, Kolb in view of Zacouto discloses the claimed invention except for includes a patch implantable along a bottom of the bone plate or along the bone fasteners, wherein the patch acts as a bioresorbable nutrient matrix.
Boyce discloses includes a patch (paragraph 20, a layer added to the subsurface region of an implant) implantable along a bottom of the bone plate (paragraph 20) or along the bone fasteners, wherein the patch acts as a bioresorbable nutrient (paragraph 91 and paragraph 92) matrix (paragraph 20, crosslinking subsurface) to allow for bioactive substances to be delivered to the surgical site (paragraph 91). With respect to claim 10, Boyce discloses wherein the patch comprises a time release strip configured to be applied to a fracture at the time of surgical repair (paragraph 20 placed on the underside of the implant). With respect to claim 11, Boyce discloses wherein the patch comprises a mix of nutrients and compounds that are configured to facilitate the biologic calcification of callus (paragraph 92 includes osteoinductive factor and bone cells among other calcification promoting agents).
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 device of Kolb in view of Zacouto to include a patch implantable along a bottom of the bone plate or along the bone fasteners, wherein the patch acts as a bioresorbable nutrient matrix in view of Boyce in order to allow for bioactive substances to be delivered to the surgical site.
With respect to claim 12, Kolb in view of Zacouto and in view of Boyce discloses wherein the patch is configured to release the nutrients and the compounds after a period of time (paragraph 91) but does not specifically disclose that coincides with a time at which adequate callus formation has been achieved. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the time that coincides with a time at which adequate callus formation has been achieved, 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).
Response to Arguments
Applicant’s arguments, see remarks, filed 12/3/2025, with respect to the 112 rejection of claims 1, 3, 6 and 10-12 have been fully considered and are persuasive. The 112 rejection of claims 1, 3, 6 and 10-12 has been withdrawn.
Applicant's arguments filed 12/3/2025 have been fully considered but they are not persuasive. The applicant argues that Zacouto only discloses the system becoming less rigid over time. The examiner respectfully disagrees. Paragraph 135 states changes in the damping can be made over time. Zacouto also discloses in paragraph 253 that the device can be made rigid in compression and paragraph 354 states the rigidity can be increased, such that Zacouto discloses both increasing as well as decreasing the rigidity over time.
The applicant does not individually argue the 103 rejections of claims 3, 6 and 10-12.
The rejections are deemed proper. The examiner suggests more clearly defining the strips as the reverse dynamization feature that harden over time (as disclosed in paragraph 52) to overcome the art of record.
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.
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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