DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1-3, 5-10, 12-17, 19 and 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Copf Jr. (US Pub 2008/0200987) in view of Mears (US Patent 4,620,533).
With respect to claim 1, Copf. Jr discloses an orthopedic stabilization scaffold apparatus (See fig 1 and 2 below) an comprising: a first (Fig 2, 42a, 42b, 46a, 46b, 30 and 24) and a second anchorable frame (fig 2, 42c, 42d, 46, c, 46d, 26 and 30) connectable at a point (connected at 32b, 32c) and removably attachable (at part 44s) to an operating table (fig 1, 12) to form a substantially rigid orthopedic stabilization scaffold (abstract “rigidly connected”) for attachment of one or more external fixators (fig 2, 50, 60 and 70) for realignment of one or more bones (fig 1, 16 and 18) of a patient. With respect to claim 2, Copf. Jr discloses wherein the first anchorable frame, the second anchorable frame, or both the first and the second anchorable frames are curved to form an arch over a surface of the operating table (fig 2, 42b, 24 and 42a form an arch over the table surface); or wherein the first anchorable frame and the second anchorable frame independently comprise a shape selected from a polygon, an oval, a semicircle, a rectangle, a free-form shape or a combination thereof (the parts of each frame form free form shapes). With respect to claim 3, Copf. Jr discloses wherein one or more external fixators attach to the first anchorable frame, the second anchorable frame, or a combination thereof (Fig 2, 50, 60 and 70). With respect to claim 5, Copf. Jr discloses wherein the apparatus is configured to aid in a realignment of one or more bones of a pelvis, spine, ribs, femur, fibula, tibia, humerus, radius, or ulna (fig 1m 16 and 18 spine bones). With respect to claim 6, Copf. Jr discloses wherein the one or more external fixators comprise at least one of a clamp, an adaptor, a pin, an adaptor, a traction pin device, a ball-spike pusher device, an extension, or other surgical device used in fracture reduction (fig 1, 58 and 68). With respect to claim 7, Copf. Jr discloses wherein the apparatus anchors one or more percutaneous fracture reduction instruments (fig 1, pins are reducing the fracture).
With respect to claim 8, Copf. Jr discloses a method of treating a patient using an orthopedic fracture reduction scaffold comprising the steps of: anchoring a first anchorable frame (Fig 2, 42a, 42b, 46a, 46b, 30 and 24) and a second anchorable frame (fig 2, 42c, 42d, 46, c, 46d, 26 and 30) to an operating table (anchored at 44s), the operating table comprising a first side (see fig 2 below) opposite a second side (See fig 2 below) , wherein the first side is parallel to a patient's first arm and the second side is parallel a patient's second arm (fig 2), a head side (See fig 2 below) connecting perpendicularly the first side and the second side at a head end (fig 2), wherein a patient's head is positioned at the head end, and a foot side (see fig 2 below) connecting perpendicularly the first side and the second side at a foot end, wherein a patient's feet are positioned at the foot end (fig 2); wherein the first anchorable frame comprises a first attachment point (fig 2, 44a) and a second attachment point (fig 44b), the first attachment point is removably attachable to a first location (fig 2 at 44a) on the first side of the operating table and the second attachment point is removably attachable to a second location (fig 2 at 44b) on the first side or the second side of the operating table; wherein the second anchorable frame comprises a third attachment point (fig 2, 44c) and a fourth attachment point (fig 2, 44d), the third attachment point is removably attachable to a third location (fig 2 at 44c) on the first side of the operating table and the fourth attachment point is removably attachable to a fourth location (fig 2 at 44d) on the first side or second side of the operating table; connecting the first anchorable frame and the second anchorable frame at a point (at 32b or 32c) above the operating table to form a substantially rigid orthopedic fracture reduction scaffold for attachment of one or more external fixators (fig 2, 50, 60 and 70) to aid in a realignment (moves by 52, 62, 72 to aid in alignment) of one or more bones of a patient; connecting the one or more external fixators to one or more bones (fig 1, 58 and 68 to align the bones) and the orthopedic fracture reduction scaffold to align the one or more bones of a patient; and realigning the one or more bones (paragraph 18). With respect to claim 9, Copf. Jr discloses further comprising stabilizing the one or more bones by attaching one or more orthopedic implants, screws, plates, bolts or a combination thereof (fig 1, 58, 60 are bolts or screws). With respect to claim 10, Copf. Jr discloses wherein the step of aligning the one or more bones comprises adding, withdrawing, pushing, pulling, moving, or shifting the one or more external fixators (Fig 2, 52, 63 and 72). With respect to claim 12, Copf. Jr discloses wherein the orthopedic fracture reduction scaffold is adapted to attach to one or more bones of a pelvis, spine, ribs, femur, fibula, tibia, humerus, radius, or ulna of the patient (fig 1, spine bones). With respect to claim 13, Copf. Jr discloses wherein the first anchorable frame and the second anchorable frame independently have a shape selected from a polygon, an oval, a semi-circle, a rectangle, a free form shape, or a combination thereof (fig 1, free form shape); or wherein the first anchorable frame, the second anchorable frame or both the first and the second anchorable frame are curved to form an arch (fig 1 and 2 the frames form an arch) over a surface of the operating table. With respect to claim 24, Copf. Jr discloses further comprising attaching one or more percutaneous fracture reduction instruments (fig 1, 58, 68 and 78) to the orthopedic fracture reduction scaffold. With respect to claim 15, Copf. Jr discloses wherein the one or more external fixators comprise a clamp, a screw, an adaptor, a pin a traction pin device, a ball-spike pusher device, an extension or other surgical device used to achieve fracture reduction (fig 1, pins). With respect to claim 16, Copf. Jr discloses further comprising using a multi-planar fluoroscopic imaging device (paragraph 40) to position the one or more external fixators for the realignment of the one or more bones or a combination thereof.
With respect to claim 17, Copf. Jr discloses a kit for an orthopedic fracture stabilization scaffold comprising: a first anchorable frame (Fig 2, 42a, 42b, 46a, 46b, 30 and 24) adapted to fit an operating table; and a second anchorable frame (fig 2, 42c, 42d, 46, c, 46d, 26 and 30) adapted to fit the operating table (fig 1, 12); wherein the first and the second anchorable frames are configured to be connected at a point (Fig 2, 32) to form an arch over the operating table to form a substantially rigid orthopedic fracture stabilization scaffold (abstract) for attachment of one or more external fixators for alignment of one or more bones of a patient; and one or more external fixators (fig 2, 50, 60 and 58, 68) configured to attach to the first anchorable frame, the second anchorable frame, or a combination thereof. With respect to claim 19, Copf. Jr wherein the orthopedic fracture stabilization scaffold is used to reposition one or more bones of a pelvis, spine, ribs, femur, fibula, tibia, humerus, radius, or ulna of the patient (fig 1, spine bones). With respect to claim 20, Copf. Jr wherein the one or more external fixators comprise at least one of a clamp, an adaptor, a pin, an adaptor, a traction pin device, a ball-spike pusher device, an extension, or other surgical device used in fracture reduction (fig 1, 58, 68).
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With respect to claims 1, 8 and 17 Copf discloses the claimed invention except for specifically disclosing the material being a radiolucent material selected from carbon fiber, aluminum, an alloy, a composite, Kevlar, nylon, polyether imide resin, and combinations thereof.
Mears discloses in external fixation device (title) made from a material being a radiolucent material selected from carbon fiber (col. 16, ll. 20), aluminum (col. 7, ll. 30), an alloy (col. 7, ll. 30, a composite (col, 5, ll. 19), Kevlar, nylon (col. 5, ll. 20, polyether imide resin, and combinations thereof to be translucent on X-rays (col. 5, ll. 16).
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 and method of Copf to have the material being a radiolucent material selected from carbon fiber, aluminum, an alloy, a composite, Kevlar, nylon, polyether imide resin, and combinations thereof in view of Mears in order to be translucent on X-rays.
Response to Arguments
Applicant’s arguments, see remarks, filed 6/5/2025, with respect to the U.S.C. 112 rejection of claims 6-16 and 20 have been fully considered and are persuasive. The U.S.C. 112 rejection of claims 6-16 and 20 has been withdrawn.
Applicant’s arguments with respect to claim(s) 1-3, 5-10, 12-17, 19 and 20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 5350378 A discloses an external fixation device made from polyether imide resin and carbon fiber composites
US 4757809 A discloses an external fixation device made from Kevlar and other composites
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 STEVEN J COTRONEO whose telephone number is (571)270-7388. The examiner can normally be reached Monday-Friday 9am-5pm EST.
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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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/S.J.C/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773
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