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 § 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 1-21 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.
Claim 1 recites the limitation "the plane" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-21 are rejected as indefinite for depending upon an indefinite claim.
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) 1-5, 8-9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata et al (US Patent Pub. 20170231673A1) in view of Biedermann (US Patent Pub 20200275957A1) and Sanders et al (US Patent Pub. 20060235396A1).
Hirata recites an apparatus for stabilizing and fixating fractures, revision procedures, joint fusion, osteotomies and reconstruction of the bones of the human body. Specifically in regards to claim 1, Hirata recites a bone fusion plate (4) comprising a generally elongate member having an upper surface and a lower, bone contact surface (surface with 14); a layer structure (7a-7e, Fig. 3a-4b) comprising a series of layers of PEEK-embedded carbon fiber tape oriented at different angles (Fig. 1-4b; and Para. [0021],[0023],[0040],[0153],[0163]-[0168]). Hirata also recites two or more fixation apertures (6) disposed along the bone fusion plate and configured to receive bone screws (5); and a threaded hole (Fig. 14a-14c) comprising each of the two or more fixation apertures (6), wherein at least one of the fixation apertures comprises an elongated aperture (20, Fig. 2a) configured to receive a bone screw with respect to the plane (plane along longitudinal axis of the plate) of the bone fusion plate to facilitate compressing adjacent bone portions together (Fig. 1 and 14a-14c). Hirata also recites wherein a plate (4) length ranges between about 0.90 inches and about 10.00 inches, and about 2.00 inches, and a plate thickness ranges between about 0.04 inches and about 0.10 inches (Hirata recites wherein the plate length is 5-6cm which is 1.969in to 2.362in, and the thickness ranges from 2-3mm, or 0.0787-0.118in.) (Para. [0006],[0013],[0039],[0175]). However, the reference is silent as to the plate having an oblique slot or the width range.
Biedermann recites an apparatus for stabilizing and fixating fractures, revision procedures, joint fusion, osteotomies and reconstruction of the bones of the human body. Specifically in regards to claim 1, Biedermann recites a bone fusion plate (12) comprising a generally elongate member (32) having an upper surface (33) and a lower bone contacting surface (31), two or more fixation apertures (34/36) disposed along the bone fusion plate (12) and configured to receive bone screws (14), wherein at least one of the fixation apertures (36) comprises an elongated aperture (36) configured to receive a bone screw at an oblique angle with respect to the plane (plane along longitudinal axis of the plate) of the bone fusion plate (12) to facilitate compressing adjacent bone portions together (The hole 36 is re-orientable hole that can be moved to any angle with respect to the longitudinal axis of the plate as needed.) (Fig. 1-2; and Para. [0038]-[0041]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the slot (20) in the plate width of Hirata to be a re-orientable slot as taught in Biedermann in order to support a head of a bone fastener at various locations (Para. [0039]). However, the references are silent as to the plate width range.
Sanders recites an apparatus for stabilizing and fixating fractures, revision procedures, joint fusion, osteotomies and reconstruction of the bones of the human body. Specifically in regards to claim 1, Sanders recites a bone fusion plate (Fig. 3) with a plate length of 22.9 mm, or 0.902in, and wherein the plate width ranges between about 0.25 inches (Sanders recites wherein the plate width is 12.2mm, or 0.480in.) (Fig. 3, and Para. [0031]-[0032]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the plate width of Hirata to be in the range of .25-2inches as taught in Sanders since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or working ranges involves only routine skill in the art.
In regards to claim 2, Hirata recites wherein the threaded hole (6) is configured to accept a threaded locking drill guide tower for on-axis pilot hole preparation (The threaded holes 6 shown in Fig. 14 are more than capable of accepting threaded guides to be locked in place.) (Fig. 14a-14c).
In regards to claim 3, Hirata recites wherein the threaded hole (6) is configured to accept a threaded locking bone screw or a non-threaded bone screw (Fig. 14a-14c).
In regards to claim 4, Hirata recites wherein the PEEK-embedded carbon fiber tape includes an additional additive that provides visualization of both the fusion site and the bone plate under X-Ray (Fig. 10c; and Para. [0056],[0176],[0009]).
In regards to claim 5, Hirata recites wherein a longitudinal aspect of the bone fusion plate (4) includes one or more angles or bends such that the bone fusion plate (4) matches the anatomy of the bone to be fused (Fig. 2b; and Para. [0150],[0190],[0197]).
In regards to claim 8, Hirata recites wherein a transverse aspect of the bone fusion plate (4) includes one or more curvatures such that the bone fusion plate matches the anatomy of the bone to be fused (Fig. 2b; and Para. [0150],[0190],[0197]).
In regards to claim 9, Hirata recites wherein the bone fusion plate (4) includes any of various markings, shapes, diagrams, symbols, words, numbers, or indicators configured to assist a practitioner with correctly orienting the bone fusion plate (4) onto the bones to be treated (Para. [0056],[0176]).
In regards to claim 11, Hirata recites wherein the bone fusion plate (4) is configured to be shipped and stored in sterile packaging in a single barrier or dual barrier configuration (The plate 4 of Hirata is fully capable of being shipped in sterile packaging since it is meant to be used in the human body.).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Biedermann and Sanders as applied to claim 1 above, and further in view of Myerson et al (US Patent Pub. 20060241608A1).
Hirata in view of Biedermann and Sanders disclose a bone plate composed of peek and carbon fiber tape that contains apertures that are threaded for use with threaded or non-threaded screws. However, the references are silent as to dorsiflexion or hallux valgus angles.
Myerson recites an apparatus for stabilizing and fixating fractures, revision procedures, joint fusion, osteotomies and reconstruction of the bones of the human body. Specifically, Myerson recites a bone fusion plate (10) comprising a generally elongate member having an upper surface (19) and a lower, bone contact surface (18) (Fig. 1-4; and Para. [0020],[0030]). In regards to claims 6-7, Myerson recites wherein the bone fusion plate (10) includes a vertical angle configured to accommodate a dorsiflexion angle of the bones in a human foot, and wherein the bone fusion plate (10) includes a horizontal angle configured to accommodate a hallux valgus angle of the human foot ranging between about 2 degrees and about 10 degrees (Myerson recites the plate 10 preferably incorporates a pre-determined dorsi-flexion angle .alpha., as shown in FIG. 4, of dorsi-flexion angle of about 17 degrees for the first toe, which has been found to be anatomically optimal for most patients. While the plate is also incorporated with an acceptable varus-valgus angle may range from 5-10 degrees, with five degrees being most preferred for the majority of patients.) (Fig. 1-4; and Para. [0010],[0024],[0033]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the plate of Hirata to have dorsiflexion and hallux valgus angles as taught in Myerson in order to be able to use the plate on the foot and the range of dorsiflexion angle has been found to be anatomically optimal for most patients while the hallux valgus angle being most preferred for the majority of patients (Para. [0024],[0033]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Biedermann and Sanders as applied to claim 9 above, and further in view of Dresher et al (US Patent Pub. 20170156768A1).
Hirata in view of Biedermann and Sanders disclose a bone plate composed of peek and carbon fiber tape that contains apertures that are threaded for use with threaded or non-threaded screws, and wherein the plate includes markers. However, the references are silent as a joint line indicator.
Dresher recites an apparatus for stabilizing and fixating fractures, revision procedures, joint fusion, osteotomies and reconstruction of the bones of the human body. Specifically, Dresher recites a bone fusion plate (20) comprising a generally elongate member having an upper surface and a lower, bone contact surface (Fig. 1; and Para. [0051]). In regards to claims 10, Dresher recites wherein the bone fusion plate (20) includes a joint line indicator (94) disposed on the upper surface to assist the practitioner with aligning a longitudinal aspect of the bone fusion plate (20) with a joint to be fixated (Fig. 1; and Para. [0064]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the plate of Hirata to have a joint indicator line as taught in Dresher since by aligning the indicator with the edge of the first bone, a sufficient amount of the first bone is present for the fasteners to engage through the at least one fastener opening to secure the compression plate relative to the first bone (Para. [0064]).
Claim(s) 12 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Biedermann and Sanders as applied to claim 11 above, and further in view of Wahl et al (US Patent Pub. 20200246052A1).
Hirata in view of Biedermann and Sanders disclose a bone plate composed of peek and carbon fiber tape that contains apertures that are threaded for use with threaded or non-threaded screws, and wherein the plate includes markers. However, the references are silent as to packaging comprising inner and outer tubes or thermoformed trays.
Wahl recites a medical apparatus. Specifically, Wahl recites a medical device (112/108) (Fig. 1-2; and Para. [0023]-[0025]). In regards to claims 12, Wahl recites wherein the sterile packaging is a tube assembly (100) comprising an inner tube (120) contained inside an outer tube (116) (Fig. 1-2; and Para. [0023]-[0025]). In regards to claim 16, Wahl recites wherein the sterile packaging is a thermoform tray assembly comprising an inner tray contained inside an outer tray (Para. [0023],[0034]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the system of Hirata to have packaging comprising inner and outer tubes or thermoformed trays as taught in Wahl in order to have a secure way to ship sterile instruments (Para [0023]).
Claim(s) 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Biedermann and Sanders and Wahl as applied to claim 12 above, and further in view of Licardo et al (US Patent Pub. 20110155592A1).
Hirata in view of Biedermann and Sanders and Wahl disclose a bone plate composed of peek and carbon fiber tape that contains apertures that are threaded for use with threaded or non-threaded screws, and wherein the plate includes markers, and wherein the shipping package is a tubular assembly. In regards to claims 13-15, Wahl recites a tube assembly having inner and outer tubes (Fig. 1-2). However, the references are silent as to the packaging comprising a foldable internal retainer with clasps.
Licardo in regards to claim 13-15, recites wherein the package (100) which is configured to house an internal implant retainer (12) that is configured to protect the implant (I) within the sterile packaging (100) during shipping and storage, wherein the internal implant retainer (12) comprises: first and second halves (38/39) that share intervening fold lines (dotted line in Fig. 7-9); and a retaining cavity (cavity created by sleeve 12 to house I); and wherein the first half (38) is configured to be folded onto to the second half (39), by way of the fold lines, to surround the implant (1) between the retaining cavities such that the implant (I) is enclosed within the retaining cavities for storage and shipping within the sterile package (100) (Fig. 1-2 and 7-9; and Para. [0030]-[0033],[0037]-[0040]). Licardo recites one or more push clasps (19) disposed in each of the first and second halves (holes 49/50 and pin 19), and wherein the push clasps are configured to be pressed together (Fig. 3-4 and 7-9; and Para. [0033]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the system of Hirata to have a retainer packaging comprising a foldable sleeve as taught in Licardo in order to prevents, or at least hinders, the packaging lid from wrapping medical implant too tightly (Para [0030]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Biedermann and Sanders as applied to claim 11 above, and further in view of Bentz (US Patent Pub. 20170190492A1).
Hirata in view of Biedermann and Sanders disclose a bone plate composed of peek and carbon fiber tape that contains apertures that are threaded for use with threaded or non-threaded screws, and wherein the plate includes markers. However, the references are silent as to the packaging comprising internal and external pouches.
Bentz in regards to claim 17, recites wherein the sterile packaging (701) is a pouch assembly comprising an inner pouch (742) contained inside an outer pouch (Fig. 13-15; and Para. [0079]-[0083]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the system of Hirata to have a retainer packaging comprising a pouch as taught in Bentz in order to have a package that includes a housing portion and a handling portion, which together form a structure that can be configured to be airtight (e.g., form a hermetic seal). (Para [0035]).
Claim(s) 18-19 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Biedermann and Sanders as applied to claim 11 above, and further in view of von Hoffman et al (US Patent Pub. 20020143335A1).
Hirata in view of Biedermann and Sanders disclose a bone plate composed of peek and carbon fiber tape that contains apertures that are threaded for use with threaded or non-threaded screws, and wherein the plate includes markers. However, the references are silent as to the means of sterilization.
Von Hoffman in regards to claim 18-19 and 21, recites wherein the sterile packaging is capable of withstanding sterilization by way of GAMMA sterilization, Ethylene Oxide Sterilization, or Electron Beam sterilization (Para. [0111]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the system of Hirata to have a retainer packaging comprising a pouch as taught in von Hoffman since they are all common forms of sterilization (Para [0111]).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hirata in view of Biedermann and Sanders as applied to claim 11 above, and further in view of Treace et al (US Patent Pub. 20160235454A1).
Hirata in view of Biedermann and Sanders disclose a bone plate composed of peek and carbon fiber tape that contains apertures that are threaded for use with threaded or non-threaded screws, and wherein the plate includes markers. However, the references are silent as to the means of sterilization.
Treace in regards to claim 18-20, recites wherein the sterile packaging is capable of withstanding sterilization by way of GAMMA sterilization, Ethylene Oxide Sterilization, or steam sterilization (Para. [0031]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the system of Hirata to have a retainer packaging comprising a pouch as taught in von Hoffman since they are all common forms of sterilization (Para [0031]).
Response to Arguments
Applicant’s amendments filed on 11/3/25 have overcome the previous 101 rejections which have now been withdrawn.
Applicant’s arguments with respect to the claims have been considered but are moot because the arguments do not apply to the new combination of references being used in the current rejection.
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 MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775