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 .
Priority
This application claims priority from application 18/300820, filed 04/14/2023.
Status of Claims
Claims 1-20 are pending.
Information Disclosure Statement
The Information Disclosure Statements filed on 04/14/2023 and 05/09/2023 have been considered by the examiner.
Drawings
The objections to the drawings have been withdrawn in view of the applicant’s amendments.
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) 1-4, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cachia US 2005/0197711 A1 in view of Lauf et al (Lauf) USPN 11,554,020 B2.
Cachia discloses the invention substantially as claimed being a method of correcting a bone deformity (Figures 18A-D) comprising: forming an osteotomy in bone ([0162] discloses a passage may be made in the sinus tarsi and Figures 18A-D show the implant being inserted to form an osteotomy by dividing/separating the talus from the calcaneus); providing an expandable implant [0164] inserting and positioning the expandable implant into the osteotomy [0161]-[0164]; and expanding the implant to correct the bone deformity [0161]-[0164].
However, Cachia does not disclose an expandable implant with a pivoting endplate and the actuator/driving mechanisms.
Lauf teaches the use of 99an expandable implant (10 Figure 7) comprising: a main body 12; a moveable endplate 14 pivotably connected to the main body (pivots about pin 20), the endplate defining a pair of ramps (66); an actuator assembly (16 Figure 7) including an actuator 80 and two actuator pivots 82/83, each actuator pivot having a ring 100 received on the actuator and a foot 108 with a sliding surface configured to mate with respective ramps on the endplate (4:37-47); and a drive assembly 78 configured to move the actuator assembly, wherein movement of the drive assembly translates the actuator assembly to expand the endplate away from the main body (Figures 3-6); expanding the implant to correct the bone deformity by rotating the drive screw to translate the actuator assembly (Figures 5-6), thereby expanding the endplate away from the main body(Figures 5-6) in the same field of endeavor for the purpose of providing a fully adjustable wedge shape that can be continuously adjusted before and after insertion.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to replace the implant of with Cachia with that of Lauf in order to provide an implant that is fully adjustable wedge shape that can be continuously adjusted before and after insertion to achieve the proper angle.
2. The combination discloses the endplate is pivotably connected to the main body with a hinge pin (Lauf 20 Figures 3-6).
3. The combination discloses the endplate is angled relative to the main body (Lauf Figure 6, additionally the broadest reasonable interpretation of angled includes every angle from 0 to 360 degrees so it is inherently angled regardless of the configuration).
4. The combination discloses the main body includes a front nose (Lauf near 28 in Figure 7), an opposite rear wall (Lauf near 52 Figure 7), and a pair of sidewalls (Lauf sides of 12 in Figure 7) connecting the front nose to the rear wall defining a central cavity (Lauf open area within 12 of Figure 7).
16. The combination discloses a method of correcting a bone deformity (Cachia Abstract) comprising: forming an osteotomy in bone (Cachia [0162]); inserting an expandable implant into the osteotomy (Cachia [0161]-[0164]), the expandable implant having a main body (Lauf 12), a moveable endplate (Lauf 14) pivotably connected to the main body (Lauf Figures 4-6), an actuator assembly (Lauf 16) including an actuator (Lauf 80) and two actuator pivots (Lauf 82/83), each actuator pivot having a ring (Lauf 100) received on the actuator (Lauf Figure 7) and a foot (Lauf 108) configured to mate with the endplate (Lauf Figures 5-6), and a drive assembly (Lauf 78) including a drive screw (Lauf 78) configured to move the actuator assembly (Lauf Figures 4-6); and expanding the implant (Lauf Figures 4-6) to correct the bone deformity (Cachia Abstract) by rotating the drive screw to translate the actuator assembly (Lauf Figures 4-6), thereby expanding the endplate away from the main body (Lauf Figures 4-6).
17. The combination discloses the expandable implant has an adjustable wedge thickness configured to be dialed in by a surgeon to correct the deformity (Lauf Figures 4-6).
18. The combination discloses the bone deformity is a flatfoot deformity (Cachia Abstract).
19. The combination discloses the bone is a calcaneus of a foot (Cachia Figures 28A-B).
20. The combination discloses the osteotomy is formed on a lateral aspect of the calcaneus, and expanding the implant lengthens a lateral column of the foot (Cachia Figures 28A-B).
Claim(s) 6-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cachia and Lauf (Combination 1) as applied to claims 1-4 and 16-20 above, and further in view of Weiman et al (Weiman) US 10,709,573 B2.
9. The combination discloses a method of correcting a bone deformity (Cachia Abstract) comprising: forming an osteotomy in bone (Cachia [0162]); providing an expandable implant (Lauf Figure 7) comprising: a main body (Lauf 12) having a front nose, an opposite rear wall, and a pair of sidewalls connecting the front nose to the rear wall defining a central cavity (see claim 4 above); a moveable endplate (Lauf 14) pivotably connected to the main body (Lauf Figures 4-6), the endplate having an outer surface with a plurality of teeth (Lauf 58) configured to engage bone and an inner surface defining a pair of ramps (Lauf 66); an actuator assembly (Lauf 16) including an actuator having a cylindrical body (Lauf 98) and two actuator pivots (Lauf 82/83), each actuator pivot having a ring received on the cylindrical body of the actuator (Lauf 100) and a foot configured to mate with one of the ramps on the endplate (Lauf 108); and a drive assembly (Lauf 78), wherein the drive screw is threadedly engaged with the actuator (Lauf 94/86), and wherein rotation of the drive screw pulls the actuator (Lauf Figures 4-6), thereby causing the two actuator pivots to slide along the ramps of the endplate to expand the endplate away from the main body inserting (Lauf Figures 4-6) and positioning the expandable implant into the osteotomy (Cachia [0161]-[0164]); and expanding the implant to correct the bone deformity (Cachia [0161]-[0164]) by rotating the drive screw to translate the actuator assembly (Lauf Figures 4-6), thereby expanding the endplate away from the main body (Lauf Figures 4-6).
However, Combination 1 does not disclose a drive assembly with locking or retaining rings.
Weiman discloses a drive assembly (900 Figure 87) including a drive screw 860, a lock ring 904, and a retaining ring 890 aligned along a longitudinal axis in the same field of endeavor for the purpose of providing a means for locking the screw to prevent backing out.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the drive assembly of Lauf to include a locking ring and retaining ring in order to provide a means for locking the screw to prevent backing out.
6. The combination discloses the drive assembly includes a drive screw, a lock ring, and a retaining ring aligned along a longitudinal axis (860/890/904 Weiman Figure 87).
7. The combination discloses the actuator assembly is aligned along an axis perpendicular to the longitudinal axis of the drive assembly (Lauf Figures 6-7).
8. The combination discloses the drive screw (Lauf 78) includes a threaded shaft (Lauf 86), a distal tip with a reduced diameter (Lauf 888), and an enlarged head with a drive recess (84 Lauf Figure 13).
10. The combination discloses each actuator pivot has a smooth inner surface 100 to allow each actuator pivot to rotate on the cylindrical body of the actuator (Lauf Figures 4-7).
11. The combination discloses the two actuator pivots are fitted to each end of the cylindrical body of the actuator (Lauf Figure 7).
12. The combination discloses each foot (Lauf 108) defines a smooth sliding surface and the ramps (Lauf 66) define a corresponding smooth sliding surface such that the foot is configured to slide against the ramp to expand the endplate.
15. The combination discloses the actuator has an enlarged cylindrical band defining a bore therethrough (Lauf 94), wherein the bore is internally threaded to interface with the threaded shaft of the drive screw (Lauf Figure 7).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cachia and Lauf (Combination 1) as applied to claims 1-4 and 16-20 above, and further in view of Coyne et al (Coyne) US 2022/0008220 A1.
Combination 1 discloses the invention substantially as claimed being described above. However, Combination 1 does not disclose the rear wall of the body includes a second bore.
Coyne discloses a bone wedge having a body with a rear portion comprising a first bore for receiving the drive assembly and a second bore in communication with the central cavity of the body in the same field of endeavor for the purpose of providing a accepting an insertion tool and allowing another path for ingrowth.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the rear wall the implant to include the additional through bore to allow for the use of additional stabilizing tools and further ingrowth after insertion.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cachia, Lauf, and Weiman (Combination 2) as applied to claims 6-12 and 15 above, and further in view of Varela US 2012/0185049 A1.
Combination 2 discloses the invention substantially as claimed being described above. However, Combination 2 does not disclose the foot and ramps comprise male/female portions or arched surfaces.
Valera discloses a bone wedge having corresponding foot and ramps comprising a male projection extending into a female recess in the same field of endeavor for the purpose of providing a sliding engagement that resists slipping or separating.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the foot and ramp of the combination to include a foot with a male projection and a ramp with a corresponding female recess in order to prevent decoupling.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cachia, Lauf, and Weiman (Combination 2) as applied to claims 6-12 and 15 above, and further in view of Dewey et al (Dewey) US 2017/0216045 A1.
Combination 2 discloses the invention substantially as claimed being described above. However, Combination 2 does not disclose the foot and ramps comprise arched surfaces.
Dewey discloses a bone wedge having corresponding foot with arched projections 92 and ramps comprising a curved recess between 42/43 (Figures 8-9) in the same field of endeavor for the purpose of providing a sliding engagement that resists slipping forward or backward and biases the implant to an intermediate position.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the foot and ramp of the combination to include a foot with an arched upper surface and a ramp with a corresponding curved recess in order resist slipping to far forward or backward and biases the implant to the stable intermediate position.
Response to Arguments
Applicant's arguments filed 03/16/2026 have been fully considered but they are not persuasive. The applicant argues that the prior art of record fails to disclose the step of forming an osteotomy in bone. The applicant then cites the following definition for osteotomy: a bone cutting procedure to realign and reshape your bones or joints. This is not persuasive because the applicant proposed definition is not considered to be the broadest reasonable definition. Merriam Webster defines an osteotomy as “a surgical operation in which a bone is divided or a piece of bone is excised (as to correct a deformity)”. While an osteotomy may commonly include cutting or removing bone, it can also be accomplished by dividing bones. Additionally, the original disclosure discusses an osteotomy, but fails to provide a specific definition, limiting it to only cutting bones. As explained above Cachia discloses insertion within the sinus tarsi, but his procedure is considered to qualify as an osteotomy because [0162] discloses that a passage may be made in the sinus tarsi and Figures 18A-D clearly show the implant being inserted within the passage to form an osteotomy by dividing/separating bones. Specifically the method separates and divides the talus from the calcaneus by inserting the implant as a spacer). The bones are considered to be reshaped because they have been spread apart and angled differently.
Additionally, it is noted that the act of placing a wedge implant within a cut portion of bone instead or a space between bones does not rise to a novel aspect. A quick search of osteotomy, wedge, and the main bones of the ankle resulted in thousands of references including SU 1650113, which dates back to 1991. Furthermore US 20150216575, 2017/0056031, 2018/0008419, and 20180228498, all clearly teach that the use of wedge implants to fill osteotomy of a bone in the foot is old and well known in the art.
In order to advance prosecution the applicant is advised to better define the osteotomy step/location, the position/orientation of the implant when being expanded, and the overall shape of the ramps. If the applicant has specific wording to propose they are encouraged to call the examiner to discuss possible amendments.
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (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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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
Prosecution Insights