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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/19/26 has been entered.
Drawings
Drawing amendments filed 2/19/26 are acceptable.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 6-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Harshman et al. (US Patent No. 9498264 B2).
Regarding Claim 1, Harshman discloses a bone fixation device (1600, fig. 16), comprising: a continuum morphable hollow shell structure including a proximal end and a distal end; an implantation head at the proximal end including an aperture; and a screw thread positioned external to the shell structure between the implantation head and a screw tip positioned at the distal end (see figure below),wherein the continuum morphable hollow shell structure is configured to retain a castable filler material (Shell segments 1604 have aligned central openings as can be seen in Fig. 18A-B, these openings are denoted as an example in Fig. 5B, 5D as 508. These openings form a hollow core which is fully capable of having a filler material injected therethrough. the filler material would be fully capable of forming a stiffening core within the shell as the material could harden within the core space).
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Regarding Claim 2, the implantation head comprises a screw head (shown above, 1610 is a surface which acts as a screw head to allow the device to be screwed into bone).
Regarding claim 3, the shell structure is cylindrical (shown above).
Regarding Claim 6, the shell structure has a length in the range of 1 cm to 50 cm (col. 15; ln. 4-45).
Regarding Claim 7, the shell structure comprises at least one of ABS, PLA, biomaterial, polyamide, PEEK, titanium, nitinol, and cobalt-chrome alloys (col. 10; ln. 47-67).
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) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Fallin et al. (US Patent No. 10,492,838 B2).
Regarding Claim 4-5, Harshman discloses the shell structure has an outer diameter in the range of 2 mm to 20 mm (“the diameter may be about 5 mm, about 6 mm, about 7 mm, about 8 mm, about 9 mm, about 10 mm, about 11 mm, about 12 mm, about 13 mm, about 14 mm, about 15 mm, or any diameter between any of the listed diameters”, col. 15; ln. 4-45). Harshman is silent to the inner diameter or wall thickness of the shell structure or the size of the threads.
Fallin discloses a flexible bone implant in the same field of endeavor comprising a flexible shell structure with an inner diameter (diameter of cannulation 101 for guidewire) of 1-2 mm (col. 3; ln. 50) and an outer diameter (116) of 2.5-3.5mm (Col. 3; ln. 49) and therefore a wall thickness range of .5-1mm. Further, Fallin teaches a thread pitch is most preferably 2.75 mm (col. 15; ln. 44-49). Fallin teaches these dimensions for the purpose of securing to a particular bone for repair.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the dimensions of the device of Harshman to have an inner diameter of 1-2 mm and an outer diameter of 2.5-3.5mm and therefore a wall thickness range of .5-1mm and a thread pitch of 2.75 mm in order to be a suitable size shown in the art to secure to the bone.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Adam et al. (US Publication No. 2020/0315662 A1).
Regarding Claim 8, Harshman discloses the device of claim 1 as described above. Harshman is silent to how the shell structure is made.
Adam discloses flexible implants in the same field of endeavor. Adam discloses creating the flexible implants, made from materials such as titanium alloys [0102] through additive manufacturing (e.g. 3D printing) to quickly manufacture both simple and complex parts without tooling and without the need for assembly of different parts [0089].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to make the continuum morphable hollow shell structure of Harshman by 3D printing as taught by Adam in order to manufacture without tooling and without the need for assembly.
Claim(s) 9, 13-15, 19, 22, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Cummins et al. (US Publication No. 2018/0008329 A1).
Regarding Claim 9, Harshman discloses a bone fixation device (1600, fig. 16), comprising: a continuum morphable hollow shell structure including a proximal end and a distal end; an implantation head at the proximal end including an aperture; and a screw thread positioned external to the shell structure between the implantation head and a screw tip positioned at the distal end (see figure below),wherein the continuum morphable hollow shell structure is configured to retain a castable filler material (Shell segments 1604 have aligned central openings as can be seen in Fig. 18A-B, these openings are denoted as an example in Fig. 5B, 5D as 508. These openings form a hollow core which is fully capable of having a filler material injected therethrough.);
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at least one reinforcement wire (1608n, Fig. 16) configured for insertion into the bone fixation device (Fig. 16). The fixation device of Harshman is cannulated due to the aligned central openings, however Harshman is silent to a castable filler material configured for insertion into the bone fixation device.
Cummins discloses a cannulated bone fixation screw in the analogous art of orthopedic fixation screws. Cummins teaches the cannulation allows the screw to be inserted with orthopedic instrumentation and further, the screw can be used in conjunction with bone cement that is injected into the bone structure into which the orthopedic screw is inserted so as to stabilize the bone structure and to increase the purchase of the screw in the bone [0023-0024].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to inject through the cannulated bone fixation device of Harshman a bone cement (castable filler material) as taught by Cummins in order to stabilize the bone structure and to increase the purchase of the screw in the bone.
Regarding Claim 13, Harshman discloses the at least one reinforcement wire (1608n) comprises at least one of Nitinol, stainless steel, titanium, and carbon fiber (col. 8; ln. 6-10)
Regarding Claim 14, the stiffness of the system is fully capable of being configured based on a finite element analysis modeled developed based on a target bone mineral density and target bone anatomy by changing the material properties of the castable filler material. (the system’s parameters (wire thickness, cement type, material type etc.) can be configured using such a method, the finite element analysis model is not positively required by the claim).
Regarding Claim 15, Harshman discloses a bone fixation method, comprising:
fabricating a bone fixation device including a continuum morphable hollow shell structure including a proximal end and a distal end, an implantation head at the proximal end including an aperture, and a screw thread positioned external to the shell structure between the implantation head and a screw tip positioned at the distal end (see structure defined in rejection of claim 9 above, method of making discussed by Harshman in col. 14; ln. 10-20);
drilling an implantation trajectory (col. 14; ln. 37-67);
implanting the bone fixation device (col. 14; ln. 37-67);
implanting at least one reinforcement wire within the bone fixation device (fibers 1608n are part of device and implanted therewith). Harshman is silent to injecting the bone fixation device with a castable filler material via the aperture of the bone fixation device.
Cummins discloses a cannulated bone fixation screw in the analogous art of orthopedic fixation screws. Cummins teaches the cannulation allows the screw to be inserted with orthopedic instrumentation and further, the screw can be used in conjunction with bone cement that is injected into the bone structure into which the orthopedic screw is inserted so as to stabilize the bone structure and to increase the purchase of the screw in the bone [0023-0024].
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to inject through the cannulated bone fixation device (via the accessible aperture) of Harshman a bone cement (castable filler material) as taught by Cummins in order to stabilize the bone structure and to increase the purchase of the screw in the bone.
Regarding Claim 19, Harshman discloses the bone fixation device is fabricated by at least one of additive manufacturing and molding (molding described by Harshman in col. 14; ln. 10-20).
Regarding Claim 22, Cummins discloses that the cement is injected in situ (cement is injected into the bone structure into which the orthopedic screw is inserted, [0023-0024])
Regarding Claim 23, Harshman discloses the at least one reinforcement wire (1608n) comprises at least one of Nitinol, stainless steel, titanium, and carbon fiber (col. 8; ln. 6-10)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Cummins et al. (US Publication No. 2018/0008329 A1) in further view of Janna et al. (US Publication No. 2015/0257799 A1)
Regarding Claim 10, Harshman in view of Cummins discloses the system of claim 9 in the rejection above. Harshman in view of Cummins is silent to at least one strain gauge configured for insertion into the bone fixation device.
Janna discloses an intermedullary bone implant [0051] in the same field of endeavor which comprises a strain gauge integrated into the implant to monitor the biomechanical forces exerted on it during fracture healing if the data can be used to decouple the load sharing environment between the implant and the surrounding bone [0008].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to integrate a strain gauge within the bone implant of Harshman in view of Cummins as taught by Janna in order to monitor the biomechanical forces exerted on it during fracture healing.
Claim(s) 11, 12, 20, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Cummins et al. (US Publication No. 2018/0008329 A1) in further view of Yi et al. (CN 103432624 A).
Harshman in view of Cummins discloses the system/method of claim 9/15 in the rejection above. Cummins is silent to the specific material of the filler bone cement.
Yi discloses a bone cement in the analogous art of bone fixation cements which comprise injectable bismuth-based alloy (i.e. Field’s metal [0010]) with low melting point [0026] for the purpose of using a cement with good biocompatibility and short curing time [0023, 0027, 0028].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to use a low-melting point alloy bone cement such as Field’s metal taught by Yi as the bone cement in the device of Harshman in view of Cummins since Yi shows that this material is suitable for implantation for orthopedic cements.
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Cummins et al. (US Publication No. 2018/0008329 A1) in further view of Gelaude et al. (WO 2016/102025 A1).
Regarding Claim 16, Harshman in view of Cummins discloses the method of claim 15 as described above. Harshman does not describe the surgical planning method comprising characterizing a target bone tissue including identifying regions of osteoporotic bone and bone with low mineral density, and forming the implantation trajectory based on the characterization.
Gelaude discloses, in the analogous art of surgical planning for introducing a bone fixation device, creating a trajectory for the bone fixation device by evaluating bone density (by scanning, see page 2; ln. 27-34, density described in page 6;ln. 29-page 7; ln. 4 and pg. 12; ln. 30-31, Fig. 7) and creating a fixation score based on bone density measurements obtained from a patient scan (page 7; ln.1 ) and further selecting the fixation configuration having the highest score to receive the bone fixation device (claim 1 of Gelaude). Gelaude discloses that the method can be applied to any time of bone fixation devices (pg. 8; ln. 1-3).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to plan the trajectory or placement of the fixation device of Harshman in view of Cummins by using bone density scan data to create a fixation score and use the highest fixation score (implant in highest density areas) to determine the implant trajectory as taught by Gelaude in order to most strongly secure the threads of device of Whittaker in the bone.
Regarding Claim 17, the implantation trajectory is configured to avoid the identified regions of osteoporotic bone and bone with low mineral density (as taught by Gelaude, the highest fixation score is selected and based on density, this would be the densest bone (i.e. avoidance of low density bone).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Cummins et al. (US Publication No. 2018/0008329 A1) in further view of Gelaude et al. (WO 2016/102025 A1) in further view of Urvoy et al. (US Publication No. 2021/0100629 A1).
Regarding Claim 18, the methods of claim 16 as taught by Harshman in view of Cummins in view of Gelaude is described above. Gelaude discloses that CT scans of the patient’s bone can be done and converted into 3D models to use finite element analysis to create the fixation score (see claim 11 of Gelaude). Gelaude discloses visualizing bone density measurements from the scan data (page 12; ln. 26-31, Fig 7) which is a way of demarcating regions of low density (see Fig. 7), however Gelaude is silent to using specifically QCT scans but does describe any types of scan can be used (page 2; ln. 26-30).
Urvoy discloses using quantitative computed tomography (QCT) scans on the target bone tissue to generate bone density data in the analogous art of bone fixation surgical planning [0020, 0073].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to use a QCT to generate the bone density data since this is a known way of scanning the bone which would predictably generate patient data for FEA and surgical planning.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harshman et al. (US Patent No. 9498264 B2) in view of Cummins et al. (US Publication No. 2018/0008329 A1) in further view of Donovan et al. (US Patent No. 12,082,876 B1).
Regarding Claim 24, Harshman in view of Cummins discloses the method of claim 15 as described above. Harshman in view of Cummins is silent to drilling being performed with a flexible steerable drilling robot configured to create at least one of a straight, a curved, or a complex trajectory.
Donovan discloses an introducer drill to access a target treatment region within bone along a curved trajectory which is a robotic drill cable of creating at least one of a straight, a curved, or a complex trajectory (col. 5; ln. 4-15) in order to facilitate access to the target treatment locations within bone along a curved trajectory (col. 1; ln. 11-17).
It would have been obvious to one having ordinary skill in the art at the time the invention was filed to use a flexible steerable drilling robot as taught by Donovan configured to create at least one of a straight, a curved, or a complex trajectory in order to assist in forming the trajectory of the implant of Harshman in view of Cummins in order to facilitate access to the treatment locations within bone along a curved trajectory.
Response to Arguments
Applicant's arguments filed 2/19/26 have been fully considered but they are not persuasive.
Applicant argues that it would frustrate the principle of operation of the device of Harshman to inject a castable filler material into the channel since Harshman describes the channels of Harshman are configured to retain fibers which tension/slide within the channel to actuate the main body to change its curvature.
This is not found persuasive because although the device of Harshman is tensioned to change its curvature during implantation, the curvature is finalized and the device is intended to retain its shape (“made rigid”) in the body to secure the bone Harshman col. 21, ln. 33-35. Once it is implanted and placed into the desired configuration through tensioning of the fibers the device is no longer intended to be movable. This is evidenced by the tightening mechanism (fixation element) described in Harshman col; 18; ln. 9-14, col. 27:ln. 46-50; col. 29; ln. 63-67. It is at this point in the installation process where the device would be fully capable of receiving a bone cement. Bone cement or hardenable filler material capable of being introduced at this point in the installation would form a stiffening core within the shell structure as it would harden within the space in the channel.
Not only would the acceptance of bone cement not have interfered with the manipulation of the fibers (because they had already been tensioned and secured in final placement , see Harshman col. 29; ln. 63-67) but the added benefit of injecting bone cement once final placement of the device had been achieved would be to stabilize the bone structure and to increase the purchase of the screw in the bone as taught by Cummins[0023-0024]. Therefore, the examiner maintains the rejections set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773