DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
In view of the amendments filed on 2/3/2026, the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph rejections and the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejections, cited in the office action of 11/3/2025, are moot.
Applicant’s arguments with respect to claim(s) 34, 36-46, and 59-66 have been considered, but are moot in view of the new grounds of rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 34, 36-38, and 43-46 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Marino (US Pat. No. 4,733,654).
Marino discloses the following regarding claim 34: a fracture fixation apparatus comprising: an intramedullary structure (1, 2) comprising a first hole (24); an extramedullary structure (19) comprising a second hole (31) and configured to directly contact a surface of at least one bone segment (Fig. 1); and an alignment arm (14) connected to the intramedullary structure (Fig. 1), wherein the alignment arm aligns the intramedullary and extramedullary structures (Fig. 1) such that a first fastener (26) can be placed through the first hole and the second hole (Fig. 1; col. 2, lines 31-col. 3, lines 14). Please note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Marino discloses the following regarding claim 36: the fracture fixture apparatus of claim 34, wherein the extramedullary structure is a femoral component (Fig. 1; col. 2, lines 31-col. 3, lines 14).
Marino discloses the following regarding claim 37: the fracture fixture apparatus of claim 34, wherein the extramedullary structure is a bone plate (Fig. 1).
Marino discloses the following regarding claim 38: the fracture fixture apparatus of claim 34, wherein the alignment arm is further connected to the extramedullary structure (Fig. 1).
Mario discloses the following regarding claim 43: the fracture fixture apparatus of claim 34, wherein the alignment arm and the intramedullary structure are both configured to receive a guide wire (Fig. 1, where the openings within the alignment arm and intramedullary structure are fully capable of receiving guide wires).
Marino discloses the following regarding claim 44: the fracture fixture apparatus of claim 34, wherein the intramedullary structure is further configured to provide fixation of at least one fracture between a plurality of bone segments (col. 3, lines 7-14).
Marino discloses the following regarding claim 45: the fracture fixture apparatus of claim 34, wherein the extramedullary structure is further configured to provide fixation of at least one fracture between a plurality of bone segments (col. 3, lines 7-14).
Marino discloses the following regarding claim 46: the fracture fixture apparatus of claim 34, wherein the extramedullary structure and the intramedullary structure are together configured to provide fixation of at least one fracture between a plurality of bone segments (col. 3, lines 7-14).
Claim Rejections - 35 USC § 103
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.
Claims 39-41, 59-62, and 64-66 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marino in view of Gotfried (Pub. No. US 2005/0010223 A1).
Regarding claims 39-41, Marino discloses the limitations of the claimed invention, as described above. While it further recites the use of additional alignment arm instruments to facilitate drill positions (Figs. 5-6; col. 3, lines 15-59), it does not explicitly recite using first, second, and third cannulas to facilitate fastener placement. Gotfried teaches that it is well known in the art that fracture fixation devices comprise an alignment arm comprising a first cannula (top element 464) that facilitates the first fastener to be placed through the first hole and the second hole (Fig. 8; paras. 0114-0116); a second cannula of the alignment arm (middle element 464) that facilitates a second fastener to be placed through a third hole (446, middle hole of element 412) of the intramedullary structure (Fig. 8; paras. 0115-0116); and a third cannula (bottom element 464) of the alignment arm that facilitates a third fastener to be placed through a fourth hole (444, bottom hole of element 412) of the intramedullary structure (Fig. 8; paras. 0115-0116). This configuration allows the user to more easily and accurately apply the fasteners to the device and the additional holes and fasteners will more securely anchor the device to the bone. It would have been obvious to one having ordinary skill in the art to apply the cannulation instruments and additional holes and fasteners to the fixation apparatus taught by Gotfried to the devices of Marino, in order to more easily and accurately apply the fasteners to the device and to more securely anchor the device to the bone. Such a modification would be made with a reasonable expectation of success.
Regarding claims 59-62 and 64-66, Marino teaches the following regarding claim 59: a fracture fixation apparatus comprising: an intramedullary structure (1, 2) comprising a first hole (24); an extramedullary structure (19) comprising a second hole (element 31 aligned with element 24) and a bone contacting surface for placement against an exterior surface of at least one bone (Fig. 1); a first fastener (26); a second fastener (27); and an alignment arm (19) connected to the intramedullary structure (Fig. 1).
While it further recites the use of additional alignment arm instruments to facilitate drill positions (Figs. 5-6; col. 3, lines 15-59), Marino does not explicitly recite the alignment arm further comprising first, second, and third alignment features. Gotfried teaches that it is well known in the art that fracture fixation devices comprise an alignment arm comprising a first cannula alignment feature (top element 464) aimed at the first hole (Fig. 8) to facilitate insertion of the first fastener into the intramedullary structure (Fig. 8; paras. 0117-0120); and a second alignment feature (middle element 464) aimed at the second hole to facilitate insertion of the second fastener into the intramedullary structure and the extramedullary structure (Fig. 8; paras. 0114-0117). The first alignment feature or the second alignment feature comprises a cannula (Fig. 8). A third fastener (lowest bone screw) (paras. 0114-0117) and the extramedullary structure further comprising a third hole (lowest element 458), and the alignment arm further comprises a third alignment feature (lowest element 464) aimed at the second hole to facilitate insertion of the third fastener into the extramedullary structure (Fig. 8; paras. 0109-0120). This configuration allows the user to more easily and accurately apply the fasteners to the device and the additional holes and fasteners will more securely anchor the device to the bone. It would have been obvious to one having ordinary skill in the art to apply the cannulation instruments and additional holes and fasteners to the fixation apparatus taught by Gotfried to the devices of Marino, in order to more easily and accurately apply the fasteners to the device and to more securely anchor the device to the bone. Such a modification would be made with a reasonable expectation of success.
Marino teaches the following regarding claim 62: the fracture fixation apparatus of claim 59, wherein the alignment arm is further connected to the extramedullary structure (Fig. 1).
Marino teaches the following regarding claim 64: the fracture fixture apparatus of claim 59, wherein the alignment arm and the intramedullary structure are both configured to receive a guide wire (Fig. 1, where the openings within the alignment arm and intramedullary structure are fully capable of receiving guide wires).
Marino teaches the following regarding claim 65: the fracture fixture apparatus of claim 59, wherein at least one of the intramedullary structure and extramedullary structure is further configured to provide fixation of at least one fracture between a plurality of bone segments (col. 3, lines 7-14).
Marino teaches the following regarding claim 66: the fracture fixture apparatus of claim 59, wherein the extramedullary structure and the intramedullary structure are together configured to provide fixation of at least one fracture between a plurality of bone segments (col. 2, lines 31-col. 3, lines 14).
Claim 42 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marino in view of Neufeld (US Pat. No. 4,103,683).
Marino discloses the limitations of the claimed invention, as described above. However, it does not recite the alignment arm being connected to the intramedullary structure by a threaded component. Neufeld teaches that it is well known in the art that an alignment arm (20) is connected to an intramedullary structure (10) by a threaded component (30) (Fig. 1; col. 4, lines 43-col. 5, lines 7), for the purpose of securely attaching the components together and allowing for an easier disassembly. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the alignment arm of Marino to comprise a threaded component to attach to the intramedullary structure, as taught by Neufeld, in order to securely attach the components together and to allow for an easier disassembly. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, substituting one type of attachment means for another, is generally considered to be within the level of ordinary skill in the art.
Claim 63 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Marino in view of Gotfried, further in view of Neufeld (US Pat. No. 4,103,683).
Marino, as modified by Gotfried, teaches the limitations of the claimed invention, as described above. However, they do not recite the alignment arm being connected to the intramedullary structure by a threaded component. Neufeld teaches that it is well known in the art that an alignment arm (20) is connected to an intramedullary structure (10) by a threaded component (30) (Fig. 1; col. 4, lines 43-col. 5, lines 7), for the purpose of securely attaching the components together and allowing for an easier disassembly. It would have been an obvious matter of design choice to one having ordinary skill in the art to modify the alignment arm of Marino and Gotfried to comprise a threaded component to attach to the intramedullary structure, as taught by Neufeld, in order to securely attach the components together and to allow for an easier disassembly. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, substituting one type of attachment means for another, is generally considered to be within the level of 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 Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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