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
Applicant's arguments filed 1/20/2026 have been fully considered but they are not persuasive. Regarding the rejection of claim 59 under 35 U.S.C. 112, first paragraph, applicant argues the claims are supported by the written specification because there is an example where the stabilizing member completely encircles the outside of the femoral bone and another example where the stabilizing member could comprise a plurality of parts each covering smaller portions. While it’s true that the specification provides these examples, neither example specifically discloses “the stabilizing member has a circumferential extension for meshing with more than 50% of the outer surface of the femoral bone”. The specification never uses the term “50%” or half therefore the specific value of “more than 50%” is directed to new matter.
Applicant’s arguments regarding the rejection of claims 53, 54, 56, and 58-60 under 35 U.S.C. 103(a) as being unpatentable over Linares have been fully considered but they are not persuasive. Applicant argues the examiner is mixing different embodiments of Linares in order to argue that it would have been obvious for a skilled person starting from Linares to end up with a method for mounting a medical device for fixation in a femoral bone of a patient. It is true that the examiner relies on different embodiments of Linares to arrive at the claimed invention. This is why the rejection is under 35 U.S.C. 103(a) instead of 35 U.S.C. 102(b). The examiner does not combine the embodiments without teachings and instead explains why a person of ordinary skill in the art would have found it obvious to combine teachings of particular embodiments to arrive at the claimed invention.
Applicant argues the device in Linares with the branches in bone marrow can harm the bone by scraping, which is avoided by the present inventive concept, but applicant does not explain what particular inventive concept avoids the supposed scraping. If applicant means the “substantially flat bone contacting portion” avoids bone scraping, this is not persuasive because the examiner applies the teachings from the embodiment of fig.7 of Linares that comprises bone contacting portions that are flat.
Applicant argues there is no reason for the skilled person to adapt the embodiment shown in fig.1 of Linares with a device to adjust and increase a radial force to tighten the clamping force. Applicant argues increasing the radial force outside the bone on the embodiment shown in fig.1 would harm the bone and the patient would be greatly harmed. This is not persuasive because both of the fig.1 and fig.6 embodiments attach to the bone by clamping the cut end of the bone. Fig.6 simply adds radially directed pins for further securing the implant to the bone. Since Linares specifically teaches the pins for aiding in securing the implant to bone, it is unlikely doing so would harm the bone or patient, otherwise Linares would not suggest such an option. Further, applicant has not sufficiently explained how adding the pins would harm the bone. The instant application functions the same way as the device of Linares with the combined features as discussed in the rejection below, e.g. internal bone contacting surfaces that contact the inside surface of the bone and a radial clamping force on the outer surface of the bone. To argue that the combination taught by Linares would be harmful to the patient implies applicant’s invention would also be harmful to the patient. The examiner maintains modifying Linares to arrive at the claimed invention would have been obvious to a person of ordinary skill in the art as discussed in detail below.
Applicant did not address the rejection of claims under 35 U.S.C. 112, second paragraph, therefore, the rejection is maintained.
Claim Objections
Claim 53 is objected to because of the following informalities: In the last line of claim 53, “in” is believed to be in error for --on-- (see previous claim 54 which recited “on the outer surface of the femoral bone”). Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 59 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not disclose that the stabilizing member has a circumferential extension for meshing with more than 50% of the outer surface of the femoral bone. “the outer surface of the femoral bone” includes the entire outer surface of a femoral bone extending from a proximal end of the bone to a distal end of the bone including the shaft. The figures only show the stabilizing member located at the proximal end of the femoral bone and do not show a stabilizing member meshing/engaging more than 50% of the outer surface of the femoral bone. Par. 101 of the specification as filed recites “The stabilizing member could be adapted to completely encircle the outside of the femoral bone 7 or covering the entire cut surface 610”. “50%” or half is never mentioned in the specification.
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 53, 56, and 58-60 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.
Regarding claim 53, line 16 recites “wherein the contacting surface is substantially flat”. The scope of “substantially flat” is unclear. The specification does use the term “flat”. The only embodiment that shows flat bone contacting surfaces of an expanding portion is the embodiment of figs. 9a and 9b (non-elected species). In figs. 9a-9b, cross-sections A-A show flat bone contacting surfaces. But in the elected species shown in figs. 3a-8b and 10-14 each of the cross-sections A-A shows rounded bone contacting surfaces. Therefore, since the specification does not discuss “flat” or “substantially flat” surfaces, and the elected embodiment shows round bone contacting surfaces, is it unclear what the scope of “substantially flat” is as it pertains the elected embodiment.
Claim 59 requires a circumferential extension for meshing with more than 50% of the outer surface of the femoral bone. An outer surface of a femoral bone includes all outer surfaces of the femoral bone including the proximal portion, shaft, and distal portion. It is unclear how the circumferential extension could mesh/engage more than 50% of the outer surface of the femoral bone.
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.
Claims 53, 56, and 58-60 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Linares US 2011/0035022 (hereafter referred to as Linares).
Regarding claim 53, Linares discloses a method for mounting a medical device for fixation in a bone of a patient, the method comprising: a. cutting a skin portion of the patient, b. dissecting a region of a patient, c. surgically affecting and opening the bone (see par. 16 which discloses “a sectioned end of a patient’s bone 12” and figures 1-2; since the end of the bone is sectioned and opened as shown in figs. 1-2, steps a-c were inherently and necessarily carried out prior to the medical device being inserted in the bone), d. inserting an expanding portion 22 of the medical device at least partially into the bone (fig.1), e. expanding the expanding portion within the bone, such that a bone contacting surface (surface of 32) is placed in contact with the inside of the bone for fixating the medical device directly or indirectly to the cortical bone (fig.2), and f. stabilizing the medical device to the bone with a stabilizing member (considered the member 10) having a clasping portion 16 wherein the stabilizing member is placed in contact with at least two distanced portions 18 of an outer surface of the bone, so as to radially stabilize the medical device relative the bone (figs. 1-2 show the clasping portion 16 located at opposing sides of the bone distanced/spaced diametrically apart, wherein the clasping portion clamps around the sectioned bone end which radially stabilizes the medical device). The embodiment of figs. 1-2 of Linares discloses the invention substantially as claimed, but figs. 1-2 of Linares show bone contacting surfaces that are pointed instead of flat. However, fig. 7 of Linares teaches the bone contacting surfaces can be flat and discloses the bone contacting surfaces are for securing against an inner perimeter of the bone (par.27). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the pointed ends of figs. 1-2 to be flat ends as taught in fig.7 since Linares teaches both shapes are suitable for securing the device against the inside of the bone. Such a shape substitution would have been obvious to a person of ordinary skill in the art since simple substitution of the one known shape for the other would yield predictable results. Regarding the step of adjusting a radial clamping force in/on the outer surface of the femoral bone, while the embodiment of figs. 1-2 clamps the end of the cut bone, the embodiment of figs. 1-2 does not disclose adjusting a radial clamping force on the outer surface of the femoral bone. However, the embodiment of fig.6 teaches pins 64 and 66 extending from an outer surface and through the bone for the purpose of securing the device to the bone (par.25). When the pins are inserted, the radial clamping force on the outer surface of the femoral bone inherently changes/adjusts. While Linares does not specifically disclose combining the embodiments, it would have been obvious to one of ordinary skill in the art at the time of the invention to apply the pins of the embodiment of fig.6 to the clamping portions of the device of the embodiment of fig.1 in order to firmly secure the device to the bone. Finally, Linares discloses the invention substantially as claimed but does not specifically disclose that the bone is a femoral bone of a hip joint. However, Linares teaches the implant can be configured so that it mimics a joint defining end face for use in a hip in par.16. As would be understood by a person of ordinary skill in the art, the joint defining end face for use in a hip is a femoral head of a femoral bone. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to carry out the method of Linares in a hip region of a patient and fixate the medical device in a femoral bone as taught by Linares, in order to repair a femoral bone of a hip joint.
Regarding claim 56, see figs. 1-2 for operating device 28 adapted to operate the expanded portion (par.20 discloses rotating nut 28 to pivot/expand the branches 32). It is customary to rotate a hex nut either manually or with a motorized tool.
Regarding claim 58, the portion of the stabilizing member that extends across the cut bone end 18 is considered a circumferential extension for meshing/engaging with at least a part (the cut surface) of the outer surface of the bone (figs. 1-2).
Regarding claims 59 and 60, figs. 1-2 of Linares show circumferential extensions engaging the cut surface 18 of the bone, but Linares does not specifically state that the circumferential extension meshes with the entire cut surface of the bone (i.e., contacts the cut bone all the way around the circumference of the cut surface). However, Linares teaches “the implant 10 exhibits a three dimensional configuration with an inner facing and generally perimeter extending recessed rim, see as shown at 16 and which is sized and configured so that it annularly seats a mating sectioned edge profile, at 18, of the associated bone 12” in par.17 and discloses “An additional advantage associated with the stem locking arrangement is in preventing bone marrow from escaping from the implant to bone connection, and by virtue of the screw tightening resulting in the implant being drawn in a seal-tight fashion against the sectioned edge 18 of the bone” in par. 21. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the circumferential extension/surface 16 of Linares, if necessary, such that it extends annularly along the entire cut surface of the bone and meshes with the entire cut surface of a femoral bone in order to provide a tight seal against the bone to prevent bone marrow from escaping as taught by Linares. Meshing with the entire cut surface includes meshing with more than 50% of the cut surface.
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached on (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774