DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 2 is objected to because of the following informalities: lines 2-3 should be amended to - portion of the feet in contact with the bone structure-. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: lines 2-3 should be amended to - and removal of the device does not cause clinically relevant damage to the bone structure -. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-20 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 1:
The claim recites the limitation "the bone burr" in lines 5 and 7. There is insufficient antecedent basis for this limitation in the claim. The office has assumed this refers to the bone burr hole or bone hole recited in claim 2.
The limitation “a plurality of protrusions or a plurality of feet connected to the base and inserted inside the bone burr; the feet are in contact with and apply pressure to the inner wall of the bone hole regardless of a diameter of the bone burr for holding the bone fixation device onto a bone structure having a bone surf ace;” in lines 4-8 is unclear. This limitation is unclear because it only modifies the structure of the bone burr and the feet raising a question of if these limitations need to be taught by the reference if the structure of the bone hole and the protrusions is taught by the reference. This is because line 2 indicate the structure can include a bone burr hole or a bone hole and a plurality of protrusion or a plurality of feet. If the prior art teaches a bone hole and a plurality of protrusion does the reference need to further teach the limitations in lines 4-8 since they only modify the bone burr or feet? For the sake of examination, the office has interpreted the limitation of lines 4-8 to apply to the structures of the bone burr hole or the bone hole and the protrusions or the feet however the applicant should amend the claim to clarify.
The limitation “the bone fixation device onto a bone structure having a bone surface;” in lines 7-8 is unclear. This limitation is unclear because it established another “bone structure” which has already been established in line 2 raising a question of if multiple bone structures are required by the claim or one. For the sake of examination, the office has assumed this refers to the same bone structure. However, the applicant should amend the claim to clarify. Further, the claims are unclear because of the references to the “bone structure” in line 9 since multiple have been established in the claim raising a question of which one this limitation refers to. as indicated before, the office has assumed these limitation refer to same bone structure however the applicant should amend the claim to clarify.
Claims 2-20 are rejected due to their dependence on claim 1.
Regarding claim 2:
The claim is unclear because of the limitation “wherein the number of feet are between 2 to 4,”in line 1 of the claim. The limitation is unclear since it is modifying the structure of the feet which in claim one is one of two options (the other being the protrusions). Since the claim does not positively require the plurality of feet it’s unclear if the structure of the feet is required by the prior art since only the feet are further modified. For the sake of examination, the office has interpreted this limitation to apply to the feet or the protrusions however the applicant should amend the claim to clarify.
Claim 3 is rejected due to its dependence on claim 2.
Regarding claim 8:
The claim recites the limitation "the teeth" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 is rejected due to its dependence on claim 8.
Regarding claim 10:
The claim recites the limitation "the teeth" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15:
The claim recites the limitation "the curvature" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 17:
The claim is unclear because of the limitation “wherein the hinge is a different material than the fixation device to accommodate strain during use of the fixation device” in lines 1-2. It’s unclear how the hinge can be a different material form the fixation device since it is part of the fixation device as claim in claim 16. For the sake of examination, the office has assumed this is attempting to claim that the hinge is a different material from other structures in the fixation device. However, the applicant should amend the claims to clarify.
Regarding claim 18:
The claim recites the limitation "the teeth" in lines 1 and 2. There is insufficient antecedent basis for this limitation in the claim.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20080183191 A1 to Schoepp.
Schoepp discloses:
Regarding claim 1:
A bone fixation device (figures 1-5), comprising:
a base (30/72/72a) disposed above a bone structure (52) having a bone burr hole (50) or a bone hole (50) with an inner wall (see the inner wall of 50);
the base (30/72/72a) having a geometrical shape or a ring shape (see the ring shape/geometrical shape of 30/72/72a in figures 1-5);
a plurality of protrusions (24/80) or a plurality of feet (24/80) connected to the base (30/72/72a) and inserted inside the bone burr (as shown in figures 1-5);
the feet (24/80) are in contact with and apply pressure to the inner wall (as shown in figures 2 and 4) of the bone hole (50) regardless of a diameter of the bone burr (as shown in figures 1-5 the extension of the feet 24/80 is variable since it is adjustable based on the knobs 208/84 or the rachet 62) for holding the bone fixation device onto a bone structure (52) having a bone surface (as shown in figures 2 and 4 the bone structure 52 has a top/bone surface);
the bone fixation device is secured flat (as shown in figure 2) onto the bone structure (52) without screws or other fixation accessories (no screws into the bone structure 52 and only uses itself to secure it in place as shown in figures 1-5) into the bone surface of the bone structure (52); and
wherein the feet (24/80) is only in contact with the inner wall of the bone hole (50) for holding of the bone fixation device (as shown in figures 2, 4 and 5 the feet 24/80 are only in contact with the inner wall).
Regarding claim 2:
The device of claim 1, wherein the number of feet (24/80) are between 2 to 4 (as shown in figures 1, 3, 4 and 5 the feet number 2), and the feet (24/80) are of a design that penetrate bone without requiring rotation of a portion of the feet (24/80) in contact with bone (the feet penetrate the bone via the assembly 20/84/88/62 and the feet are not rotated along the central longitudinal axis (not screwed in place)).
Regarding claim 4:
The device of claim 1, further including a spring action member (84/88) or hinge having a material deflection without deformation to apply pressure to the inner wall of burr hole (as shown in figures 3 and 4 the spring 88 deforms and applies a force to 66/62 and 18/16 in order for the feet 24/80 to apply a force to the inner wall of the bore hole 50) .
Regarding claim 5:
The device of claim 1 further having a removable or temporary feature wherein the device is not intended for permanent fixation; and removal of the device does not cause clinically relevant damage to the bone (the device shown in figures 1-5 is removable as taught in ¶0033, “ Opposing resilient locking arms having slidably engaging interlocking teeth 62, shown schematically at 60, similar to a common surgical scissor-clamp is another mechanism that may be used for locking the plates 16, 18 in the clamped state. The locking arms 60 may be adapted to be repeatedly locked and unlocked or may be adapted to be locked only once, after which the arms must be broken or destroyed in order to unclamp the plates 16, 18.”).
Regarding claim 6:
The device of claim 1, wherein the feet (24/80) further includes a rough feature (see the teeth 82/48) for contact into the inner wall of the burr hole (50)(as shown in figures 1-5).
Regarding claim 7:
The device of claim 6, further includes a protrusion or a sharp (see 82/48 which are described as “ridges, striations, a roughened surface, hooks, or spikes” in ¶0030) for biting into or engaging the sidewall of the burr hole (50) as the device is expanded (as shown in figures 1-5).
Regarding claim 8:
The device of claim 6, wherein the teeth (82/48) has a triangular profile or a surface selected from the group consisting of a knurl, a roughened surface (see 82/48 which are described as “ridges, striations, a roughened surface, hooks, or spikes” in ¶0030), a textured surface, a raised surface, a tapered protrusion, a knife edge, and any combination thereof, and the profile depends on an expected loading of the fixation device, wherein the expected loading includes pullout, rotation, and torque (inherent function of the teeth 82/48 since they inherently resist pullout, rotation and torque since they are mounted to the bone hole 50).
Regarding claim 9:
The device of claim 8, wherein an arc length of the profile are within the burr hole and used for at least one accessory to go into or through the burr hole (see figures 1-5 and 6 which show the feet have an arc length which is smaller than the burr hole 50 in order to insert it within burr hole 50).
Regarding claim 10:
The device of claim 6, wherein the teeth are multiple rows of teeth and dependent on a clinical need (see figures 1-5 which show the teeth 82/48 with multiple rows and are dependent on the size of the hole 50 in order to maximize the grip of the device).
Regarding claim 11:
The device of claim 1, the fixation device further defines a clearance (40 as shown in figure 1) through a center of the fixation device (device shown in figure 1) for allowing access to and/or through the burr hole (50)(allows the device 14 to extend through the hole 40 into the burr hole 50).
Regarding claim 12:
The device of claim 11, wherein the clearance further includes a lateral access (see the gap between 42 as shown in figure 2) defined by the fixation device, and wherein the lateral access provides a space available from a side of the fixation device to visualize and access at least one accessory (the gap 42 allows for a view of the tool 14 and further allows the tool 14 to extend through 44 into the burr hole 50).
Regarding claim 13:
The device of claim 11, wherein the at least one accessory is selected from the group consisting of an implant, an instrument (work instrument 14 as described in ¶0036), a catheter, a needle, a biopsy needle, a stent, an endoscope, an ultrasonic probe, a DBS lead, an intraoperative device, a sensor, a registration, a fiduciary marker, a diagnostic device, a guide, a surgical device, equipment, and any combination thereof.
Regarding claim 14:
The device of claim 1, further includes a flat surface (see the flat top surface of 30/72 as shown in figures 1-3) that does not deform or deflect, and wherein the flat surface is a reference surface for interface with other components (the top surface 30/72 allows for the mounting of arms 16/18).
Regarding claim 15:
The device claim 1, wherein the fixation device (structure of figure 2) is seated flat (seated flat as shown in figures 2 on the bone 52) regardless of the curvature of the bone structure (52).
Regarding claim 16:
The device of claim 1, further includes an expandable hinge (see the hinge 46 as shown in figures 4 and 5) for expansion of the fixation device; and expansion of the fixation device is achieved without an external instrument (the expansion of arms 18 and 16 around hinge 46 is achieved via the spring 88 or rachet 62 without any other instrument).
Regarding claim 18:
The device of claim 1, wherein the teeth (48/82) provides for vertical axis tensioning (holds the tool 10 in place when the teeth 48/82 is engage with the bone 52) when the teeth (48/52) are expanded radially and/or tangentially (48/82 is expanded radially outward into the bone hole 50) relative to surface of the bone structure (52).
Regarding claim 19:
The device of claim 1, further including a bone retractor (see the fastener mechanism 32/20/36 in figure 2, fastener mechanism 84 in figure 3 or ratchet mechanism 62 in figure 5 which is accordance with applicants disclosure indicating the retractor mechanism “may contain mating features (104) for use with a fastener, ratcheting feature, or mechanical locking feature”) to apply pressure to the inner wall of the burr hole for mounting of accessories (applies a force to the feet 24/80 which applies a force to the burr hole 50).
Regarding claim 20:
The device of claim 1, further including a mount (40 as shown in figure 1) attached to an external surface (see the external surface of arms 16/18 or plate 30) of the fixation device (10 in figure 1), the mount for holding accessories thereon (holds accessory 14 in place as shown in figure 1).
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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080183191 A1 to Schoepp as applied to claim 2 above, and further in view of US 6267769 B1 to Truwit.
Regarding claim 3:
Schoepp fails to disclose:
The device of claim 2, wherein the bone hole has a 14mm, 11mm, or 8mm diameter.
Truwit teaches:
An instrument guide (200) as shown in figure 2 that is attached to a burr hole (250). The reference further teaches the burr hole can range in size of 14 to 15mm. the reference teaches this is to allow instruments to be inserted into the skull (column 2, lines 1-32).
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 Schoepp to make the bone/burr hole 14mm as taught by Truwit for the purpose of introducing tools into the skull.
Note: the applicant should note that the claim could be rejected under 35 USC 102 since this claim is modifying the structure of the bone hole which is beyond the scope of the claim raising a question of if the structure of the bone hole (and modifications to it) are required to infringe it or if it is only intended use. For the sake of examination, the office has made a 35 USC 103 rejection above under the interpretation that the structure of the bone hole is required by the claim however the applicant should amend the claim to positively recite the structure and further modify the scope of the claim if they intend for this to distinguish from the prior art in some manner.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20080183191 A1 to Schoepp as applied to claim 16 above, and further in view of DE 60308569 T2 to Dalla (see English language machine translation attached to this or a previous office action).
Regarding claim 17:
Schoepp fails to disclose:
The device of claim 16, wherein the hinge is a different material than the fixation device to accommodate strain during use of the fixation device.
Dalla teaches:
A socket joint (figure 1) attached to a bone that includes a hinge. The reference further teaches the hinge can be made of a wear resistant material to reduce wear (see translation page 5 final paragraph).
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 Schoepp to make the hinge out a different material as taught by Dalla in order to resist wear (Dalla, page 5 final paragraph).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following is pertinent prior art:
US-20050182425-A1
Schulte
See the fixation device (figure 2)
US-20160317239-A1
Turner
See the fixation device (figure 1)
US-20190133708-A1
Manley
See the fixation device (figure 3)
US-4998938-A
Ghajar
See the fixation device (figure 5)
US-20030153982-A1
Pria
See the hip prothesis (figure 1)
EP-2653130-A1
DALLOLIO
See the fixation device (figure 1)
WO-9817191-A1
BERNAYS
See the fixation device (figure 2)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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/WESLEY G HARRIS/Examiner, Art Unit 3783