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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 22, 2025, has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Amendment
According to the amendment filed November 20, 2025, claim 1 has been amended. Claims 1-15 are currently pending in this application.
Response to Arguments
Applicant’s arguments with respect to the rejection of claim(s) 1, 3-4 and 13-15 under 35 U.S.C. 102(a)(1) as being anticipated by Hunziker (US 2012/0130428 A1) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hunziker (US 2012/0130428 A1) in view of Sharifi-Mehr (US 2019/0328425 A1).
Regarding claim 1, Hunziker teaches a bone nail device (100; Figs. 1-7; para. 0020), comprising:
an outer tubing (outer housing 106; Figs. 1A-2A; Note that outer housing/tubing 106 appears to be mislabeled with reference numeral “104” in Figs. 2A and 7A-C) having an inner screw thread extending over at least a part of an inner surface of the outer tubing (as shown in Fig. 7A and described in para. 0029, outer tubing 106 – mislabeled as “104” – has an inner threaded surface cooperating with threaded driver 214; also see Figs. 1A-2A), and a first bone connection member (104; Figs. 1A-1B; para. 0020),
an inner tubing (inner housing 108; Figs. 1A-2A; para. 0020; Note that inner housing/tubing 108 appears to be mislabeled with reference numeral “102” in Figs. 2A and 7A) having a second bone connection member (102; Figs. 1A-1B; para. 0020), the inner tubing being arranged inside at least a part of the outer tubing to allow a sliding axial relative movement (para. 0020 recites that “rotation of the threaded driver 214 causes the inner housing to move along a longitudinal axis with respect to the outer housing, thus extending or retracting the rod”; see claims 1-2), and
a drive unit (collectively defined by driving assembly 300 and gear reduction mechanism 124; Figs. 1-3B; para. 0020-0021), the drive unit comprising
a drive motor (defined by magnet assembly 300, having rotating magnet 110 that rotates upon application of a magnetic field; para. 0022; Figs. 1A-3B; para. 0020, 0034, “may be replaced by an electric motor that rotationally drives the gear reduction mechanism 124” as recited in para. 0033; Figs. 1A-3B; para. 0020-0022, 0034) arranged in the inner tubing and fixedly attached to the inner tubing (as shown in Figs. 1A-2B and 7A, magnetic motor assembly 300 is arranged in inner tubing 108 and attached thereto via inner bearing 201 – noting that inner tubing 108 is mislabeled with reference numeral “102” in Figs. 2A and 7A), a transport screw (threaded driver 214; Figs. 2A-2B, 7A; para. 0020) having an outer screw thread engaging the inner screw thread of the outer tubing for sliding axial movement of the inner tubing relative to the outer tubing by rotation of the transport screw (threaded driver 214 has an outer thread engaging the inner threaded surface of outer housing 106, where rotation of threaded driver due to rotation of magnet 110 causes sliding axial movement of inner housing 108 relative to outer housing 106, as described in at least para. 0028-0029 and 0034; see Figs. 1A-7C), and
a planetary gear (124; Figs. 2A-2B; para. 0023-0025) having an input end connected to the drive motor (input end at first planetary stage 204a connected to gear wheel 306 of drive motor; Fig. 2B; para. 0027) and an output end connected to the transport screw (output end stage 206 connected to transport screw, i.e. threaded driver 214; Fig. 2B).
Hunziker describes the device as an expandable rod “mounted to a patient’s spine or ribs using hooks, screws and/or other fastening mechanisms” (see para. 0004), and the disclosed the first and second bone connection members are rods, understood for attachment to bone via hooks and or screws (e.g., by each rod/connection member being received in a U-shaped recess of a pedicle screw).
Hunziker does not specifically disclose wherein the bone nail device is configured for intramedullary placement within a medullary cavity of a bone.
Sharifi-Mehr, in analogous art, is directed towards expandable rods for use in various applications (see spinal rod system 10 in Figs. 1-3 for scoliosis correction, para. 0035; expandable rod system 610 in Fig. 18 for deformity correction and/or stabilization of a long bone, para. 0079).
In a first embodiment, similar to the device and intended use of Hunziker’s expandable rod, Sharifi-Mehr teaches an expandable, telescoping spinal rod system for scoliosis correction, where the telescoping rod includes first and second bone connection portions defined by first and second end rods (see rod system 10 with first and second end rods 20, 40 in Figs. 1-3; para. 0035-0038). In this first embodiment, the ends of the bone connection members (i.e., end rods) may be secured in the pedicle screw heads, or spinal hooks or other common fixation devices may be employed (see para. 0035). This configuration is substantially the same as the bone connection members of Hunziker described above.
In a second embodiment, Sharifi-Mehr teaches an expandable, telescoping rod system having a similar structure to that of the first embodiment, and thus similar to Hunziker’s expandable rod system, particularly with regard to the first and second bone connection portions defined by first and second end rods (see rod system 610 in Fig. 18, with first and second end rods 620, 640; para. 0079). In this embodiment, Sharifi-Mehr’s expandable system is configured as a bone nail device for intramedullary placement within a medullary cavity of a long bone (see Fig. 18; para. 0079), and the first and second bone connection members (i.e. end rods) are attached to the bone via fixation members such as traditional bone screws and are shown to comprise an aperture for accommodating a traditional transverse bone screw (see Fig. 18 and para. 0079).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Hunziker’s expandable rod device as an expandable intramedullary bone nail for a long bone, configured for intramedullary placement as claimed, e.g. by modifying Hunziker’s first and second bone connection members (end rods) to comprise an aperture for a transverse bone screw so as to fix the ends of the device to respective bone portions, as taught by Sharifi-Mehr, because Sharifi-Mehr recognizes that such expandable rods can be employed for various applications, as described above, and teaches that the inclusion of bone screw apertures allows for securing the rod to bone portions of a long bone in an intramedullary application for correction of a deformity and/or stabilization of a bone.
Regarding claim 2, Hunziker and Sharifi-Mehr, in combination, disclose the device according to claim 1, wherein the first and/or second bone connection member comprises an aperture for accommodating a transverse bone fixation screw (as described above, Hunziker’s first and second bone connection members are each modified to include an aperture for a transverse bone screw as taught by Sharifi-Mehr, so that the modified device is configured for intramedullary placement and fixation within a long bone via the transverse bone screws).
Regarding claim 3, Hunziker and Sharifi-Mehr, in combination, disclose the bone nail device according to claim 1, and Hunziker discloses the device further comprising a bearing (212; Fig. 2B; para. 0028) attached to the transport screw for withstanding axial load (see Figs. 2A-2B and 7A, bearing 212 is attached to transport screw 214; para. 0028-0029).
Regarding claim 4, Hunziker and Sharifi-Mehr, in combination, disclose the bone nail device according to claim 1, and Hunziker discloses wherein the combination of drive motor (300; Figs. 1A-3B), transport screw (214; Figs. 2B, 7A) and planetary gear (124; Figs. 2A-2B) is positioned between the first bone connection member and the second bone connection member (motor 300, screw 214 and planetary gearset 124 are positioned within inner housing 108 and/or outer housing 106, thus positioned between first and second bone connection members 104, 102; Figs. 1A-1B).
Regarding claim 13, Hunziker and Sharifi-Mehr, in combination, disclose the bone nail device according to claim 1, and Hunziker discloses wherein the drive motor is an electric motor (although the drive motor described above as magnet assembly 300, Hunziker anticipates in para. 0033 that “the magnet assembly 300 may be replaced with an electric motor that rotationally drives the gear reduction mechanism 124”).
Regarding claim 14, Hunziker and Sharifi-Mehr, in combination, disclose the bone nail device according to claim 1, and Hunziker discloses wherein the drive motor is a magnetic motor driven by an external magnetic drive actuator (drive motor defined above as magnet assembly 300 is a magnetic motor, with magnet 110 that is driven by an external magnetic drive actuator, as described in para. 0034).
Regarding claim 15, Hunziker and Sharifi-Mehr, in combination, disclose the bone nail device according to claim 1, and Hunziker discloses wherein the planetary gear is a reduction gear (see para. 0020: “gear reduction mechanism 124”).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hunziker (US 2012/0130428 A1) and Sharifi-Mehr (US 2019/0328425 A1), as applied to claim 1 above, further in view of Chang (US 2014/0031870 A1).
Regarding claim 5, Hunziker and Sharifi-Mehr, in combination, disclose the bone nail device according to claim 1.
Hunziker also teaches the bone nail device comprising guiding features disposed between the outer tubing and the inner tubing to prevent relative rotation during expansion of the device (see Figs. 1-2B and para. 0029, where flats 213 on bearing 212 “prevent the inner housing [108] from spinning freely within the outer housing [106]”).
Neither Hunziker nor Sharifi-Mehr disclose wherein the outer tubing comprises a guiding slot, and the inner tubing comprises a guiding pin extending through the guide slot.
Chang, in analogous art, teaches an adjustable device comprising an inner rod telescopically movable within an outer tubing section (see Fig. 71A and 71C, showing an inner rod 142 movable within outer housing/socket 1734; para. 0277-0278), wherein the outer tubing comprises a guide slot and the inner rod comprises a guiding pin extending through the guide slot (see Fig. 71A and 71C, showing outer tubing 1734 with guide slot 1738 and a pin 1742 received by the inner rod 142, in aperture 1730; para. 0278).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunziker’s device so that the outer tubing comprises a longitudinal guide slot and the inner tubing includes a guiding pin extending through the slot, as generally taught by Chang, because where Hunziker is concerned with preventing relative rotation between the inner and outer tubing as described above, Chang recognizes that providing a guide slot and pin configuration in the claimed manner permits axial or telescoping movement between the two parts while preventing radial movement and that the length of the slot may be formed to alter the degree of telescopic movement (see Chang, para. 0278).
Regarding claim 6, Hunziker, Sharifi-Mehr and Chang teach the bone nail device according to claim 5, and Hunziker teaches wherein the combination of drive motor, transport screw and planetary gear is positioned remote from both the first bone connection member and the second bone connection member (see Hunziker, Figs. 1A-1B, where it is understood that the drive motor, transport screw, and planetary gear assemblies are housed within the outer tubing 106 and the inner tubing 108, these assemblies are remote from the first and second bone connection members 102, 104).
Claims 9, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hunziker (US 2012/0130428 A1) and Sharifi-Mehr (US 2019/0328425 A1), as applied to claim 1 above, further in view of Mittelmeier (WO 01/43652 A1) and Chang (US 2014/0031870 A1). Note that parenthetical citations to Mittelmeier are taken from the computer-generated translation attached as NPL with the Office action dated March 5, 2025.
Regarding claims 9, 10 and 12, Hunziker and Sharifi-Mehr, in combination, disclose the bone nail device according to claim 1.
Hunziker also discloses the bone nail device comprising guiding features disposed between the outer tubing and the inner tubing to prevent relative rotation during expansion of the device (see Figs. 1-2B and para. 0029, where flats 213 on bearing 212 “prevent the inner housing [108] from spinning freely within the outer housing [106]”). Further, it is noted that Hunziker’s device, as modified in view of the teachings of Sharifi-Mehr as described above, is configured for intramedullary placement in a long bone.
However, neither Hunziker nor Sharifi-Mehr not disclose [Claim 9] wherein the outer tubing comprises a curved section with a curved guide slot, [Claim 10] wherein the inner tubing is flexible in a longitudinal direction thereof, and [Claim 12] wherein the curved guide slot has a curvature with a radius larger than 500mm.
Mittelmeier, in analogous art, is directed towards a bone nail device configured for intramedullary placement in the medullary cavity of a long bone such as a femur (see bone nail 1 with elongate body 2 in Fig. 2; para. 0062), and discloses wherein the nail body “is slightly curved and has a radial curvature radius of about 1.5 m” for placement within a human femur bone (see para. 0071).
Further, in analogous art, Chang teaches an adjustable device comprising an inner rod telescopically movable within an outer tubing section (see Fig. 71A and 71C, showing an inner rod 142 movable within outer housing/socket 1734; para. 0277-0278), wherein the outer tubing comprises a guide slot and the inner rod comprises a guiding pin extending through the guide slot (see Fig. 71A and 71C, showing outer tubing 1734 with guide slot 1738 and a pin 1742 received by the inner rod 142, in aperture 1730; para. 0278).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hunziker’s modified bone nail device, which is configured for placement in the medullary cavity of a long bone, to have a curvature as taught by Mittelmeier, having a radius of about 1.5 m, i.e. larger than 500mm as claimed, and the outer tubing having a guide slot as taught by Chang, so that the guide slot accordingly has a curvature with a radius larger than 500mm as claimed, where the inner tubing would be sufficiently flexible to translate within the curved outer tubing, because Mittelmeier teaches that providing a bone nail device for a long bone with such a curvature makes the nail “particularly suitable for the human femur bone” (Mittelmeier, para. 0071) and because where Hunziker is concerned with preventing relative rotation between the inner and outer tubing as described above, Chang recognizes that providing a guide slot and pin configuration in the claimed manner permits axial or telescoping movement between the two parts while preventing radial movement and that the length of the slot may be formed to alter the degree of telescopic movement (see Chang, para. 0278).
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Pool (US 2012/0209269 A1) in view of Hunziker (US 2012/0130428 A1).
Regarding claim 1, Pool teaches a bone nail device (110; Fig. 1; para. 0047), comprising:
an outer tubing (112; Figs. 1-3C), and a first bone connection member (apertures 124 and/or fasteners 116 received therethrough; Figs. 1-5; para. 0049),
an inner tubing (114; Figs. 1-5) having a second bone connection member (122/118; Figs. 1-5; para. 0049), the inner tubing being arranged inside at least a part of the outer tubing to allow a sliding axial relative movement (as shown; Figs. 1-5; para. 0048), wherein the bone nail device is configured for intramedullary placement within a medullary cavity of a bone (see Fig. 1; para. 0047), and
a drive unit, the drive unit comprising a drive motor (shown in at least Figs. 3A-C, a drive magnet 134 disposed within a cavity of the outer tubing, described in para. 0049-0050), a transport screw having an outer screw thread (lead screw 136, engaging an inner screw thread of a nut 140 that is secured within inner tubing 114; Figs. 3A-B; para. 0049) for sliding axial movement of the inner tubing relative to the outer tubing by rotation of the transport screw (rotation of lead screw 136 translates into axial movement of the inner tubing 114 relative to the outer tubing 128; Figs. 1-3C; para. 0049), and
a planetary gear having an input end connected to the drive motor and an output end connected to the transport screw (shown in Figs. 3A-C, described in para. 0050, magnet/motor 134 with axle 161 acting as an input to planetary gear set 154, with planetary gear output shaft 144 connected to lead screw 136).
However, while Pool teaches the drive motor arranged within the outer tubing so that the transport screw, driven by the motor, engages an inner screw thread of the inner tubing, Pool does not disclose the claimed configuration where the drive motor is arranged in the inner tubing and fixedly attached to the inner tubing, and the transport screw outer screw thread engages the inner screw thread of the outer tubing for sliding axial movement of the inner tubing relative to the outer tubing by rotation of the transport screw.
Hunziker, in analogous art, teaches a bone nail device (100; Figs. 1-7; para. 0020), comprising:
an outer tubing (outer housing 106; Figs. 1A-2A; Note that outer housing/tubing 106 appears to be mislabeled with reference numeral “104” in Figs. 2A and 7A-C) having an inner screw thread extending over at least a part of an inner surface of the outer tubing (as shown in Fig. 7A and described in para. 0029, outer tubing 106 – mislabeled as “104” – has an inner threaded surface cooperating with threaded driver 214),
an inner tubing (inner housing 108; Figs. 1A-2A; para. 0020; Note that inner housing/tubing 108 appears to be mislabeled with reference numeral “102” in Figs. 2A and 7A) arranged inside at least a part of the outer tubing to allow a sliding axial relative movement (see para. 0020; claims 1-2), and
a drive unit (collectively defined by driving assembly 300 and gear reduction mechanism 124; Figs. 1-3B; para. 0020-0021), the drive unit comprising a drive motor (defined by magnet assembly 300, having rotating magnet 110 that rotates upon application of a magnetic field; para. 0022; Figs. 1A-3B; para. 0020-0022, 0034) arranged in the inner tubing and fixedly attached to the inner tubing (as shown in Figs. 1A-2B and 7A, magnetic motor assembly 300 is arranged in inner tubing 108 and attached thereto via inner bearing 201 – noting that inner tubing 108 is mislabeled with reference numeral “102” in Figs. 2A and 7A), a transport screw (threaded driver 214; Figs. 2A-2B, 7A; para. 0020) having an outer screw thread engaging the inner screw thread of the outer tubing for sliding axial movement of the inner tubing relative to the outer tubing by rotation of the transport screw (threaded driver 214 has an outer thread engaging the inner threaded surface of outer housing 106, where rotation of threaded driver due to rotation of magnet 110 causes sliding axial movement of inner housing 108 relative to outer housing 106, as described in at least para. 0028-0029 and 0034; see Figs. 1A-7C), and
a planetary gear (124; Figs. 2A-2B; para. 0023-0025) having an input end connected to the drive motor (input end at first planetary stage 204a connected to gear wheel 306 of drive motor; Fig. 2B; para. 0027) and an output end connected to the transport screw (output end stage 206 connected to transport screw, i.e. threaded driver 214; Fig. 2B).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, where Pool and Hunziker are both directed towards drive arrangements for effecting sliding axial movement between an inner tubing and an outer tubing via a magnetic drive motor and transport screw arrangement, to have modified Pool’s device to have the internal drive configuration taught by Hunziker, because Hunziker recognizes the claimed configuration with the drive motor arranged in the inner tubing and the transport screw engaging an inner thread of the outer tubing as a suitable substitute configuration for effecting the desired telescoping function.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Pool (US 2012/0209269 A1) in view of Hunziker (US 2012/0130428 A1), as applied to claim 1 above, further in view of De Jonghe (WO 2012/003555 A1).
Regarding claims 7, Pool and Hunziker teach the bone nail device according to claim 1.
Neither Pool nor Hunziker teach [Claim 7] wherein the outer tubing comprises a third bone connection member, positioned at an end of the outer tubing axially opposite from the first bone connection member, and [Claim 8] wherein the third bone connection member comprises an aperture for accommodating a transverse bone fixation screw.
De Jonghe, in analogous art, is directed towards an intramedullary bone lengthening device comprising an outer tubing and an inner tubing movable relative to one another (see outer cylinder 6 and inner cylinder 7; Figs. 7a-b and pages 5-7), the outer tubing having a bone connection aperture for a transverse screw at one end (defined by lower aperture for screw 31, shown in Figs. 7a-b; page 9, lines 13-24) and another bone connection member at an end of the outer tubing axially opposite from the other (defined by an aperture 29 for transverse bone screw 30; Figs. 7a-b).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Pool’s device to include an additional (third) bone connection aperture for receiving a transverse bone locking screw, as claimed, because De Jonghe recognizes utilizing a transverse screw in an aperture at another end of the outer tubing in a bone nail device helps to “ensure the position of the bone fragments” (see De Jonghe, page 15, lines 6-15).
Allowable Subject Matter
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter:
Claim 11 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1 and claim 11. In particular, none of the cited references teach or suggest “the inner tubing further comprising a pivotable guiding pin connection member, the pivotable guiding pin connection member comprising the second bone connection member and a guiding pin, the guiding pin extending through the curved guide slot as required by claim 11.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Other relevant prior art can be found in the attached PTO-892 form, including Forsell (US 2011/0196435 A1) which teaches expandable devices configured for placement at various locations in the body, including at least alongside a long bone (Figs. 4, 9b), alongside a spinal column (Figs. 8a-c), and within a medullary cavity of a bone (Figs. 6, 9d).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNA VICTORIA LITTLE whose telephone number is (571)272-6630. The examiner can normally be reached M-F 9a-6p EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at (571)272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNA V. LITTLE/ Examiner, Art Unit 3773 /EDUARDO C ROBERT/ Supervisory Patent Examiner, Art Unit 3773