DETAILED ACTION
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.
Claims 1-4 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0071632 (Vikinsky) in view of U.S. Patent Application Publication No. 2011/0004199 (Ross).
Regarding claim 1, Vikinsky discloses a bone fixation device (106/100/122), comprising: a pair of rings (106a/106b); a plurality of struts (100) interposed between the pair of rings (see Fig. 1C), each of the plurality of struts having an adjustable length (see paragraph [0071]); a first motor configured to adjust a length of a first strut of the plurality of struts (see paragraphs [0071], [0074], [0075], and [0083] and Fig. 1C; each strut 100 comprises an actuator 104 that includes a motor); a second motor configured to adjust a length of a second strut of the plurality of struts (see paragraphs [0071], [0074], [0075], and [0083] and Fig. 1C; each strut 100 comprises an actuator 104 that includes a motor for adjusting a length of a respective strut); and an interface module (122) that is attached to a first ring of the pair of rings (see Fig. 1C and paragraph [0095]), wherein the interface module is configured to be connected to the first motor and the second motor (see paragraphs [0103] and [0116]; interface module sends controlling signals to actuator motor), and the interface module comprising a processor (see paragraph [0091]) configured to: control the first motor to adjust the length of the first strut (see paragraphs [0091], [0093], [0094], [0103]-[0105], and [0116]; interface module 122 may simultaneously control multiple struts 100 to adjust their lengths); and control the second motor to adjust the length of the second strut (see paragraphs [0091], [0093], [0094], [0103]-[0105], and [0116]; interface module 122 may simultaneously control multiple struts 100 to adjust their lengths).
Further regarding claim 1, Vikinsky is silent regarding the interface module being removably attachable. However, Ross discloses an external fixation device (50) in which a component (10) with an interface module (see paragraph [0032]) for controlling adjustment of the external fixation device is removably attachable to the device (via fitting 30, see paragraph [0035]). Regarding claim 2, Ross suggests wherein the interface module is configured to be detached from the bone fixation device when a treatment session is over (detached via fitting 30, see paragraph [0035]; see also Abstract, one tool used to adjust multiple struts, thus, must be removable from the struts, including when treatment session is over). Regarding claim 3, Ross suggests further comprising a connecting member (fitting 30, see paragraph [0035]; see also clip, paragraph [0064]), wherein the interface module is attached to and detached from the external fixation device using the connecting member (see paragraphs [0035] and [0064]). Regarding claim 4, Ross discloses wherein the connecting member comprises a clip (see paragraph [0064]). Additionally, it would have been prima facie obvious to make the clip “quick release” in order to allow a user to minimize the time necessary for connecting and releasing the tool/motor from the strut.
Further regarding claims 1-4, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the interface module be removably attachable to the ring of the bone fixation device in order to reduce the number of parts on the bone fixation device worn by the user by having the interface module removable from the device, and/or to allow for an interface module to be usable on multiple bone fixation devices by the having the module removably attachable to each device.
Further regarding claim 1, Vikinsky appears to disclose the interface module being electrically connected to the motors (see paragraphs [0103] and [0116]). Alternatively, Ross discloses an external fixator tool (10) wherein an interface module (34/20) is electrically connected to a motor (38) of the strut to control operation of the motor (see paragraph [0013]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the interface module be electrically connected to the motors to allow for the motors to be controlled directly by the interface module (see Ross, paragraph [0013]).
Regarding claim 11, Vikinsky discloses a bone fixation device (106/100/122), comprising: a pair of rings (106a/106b); a plurality of struts (100) interposed between the pair of rings (see Fig. 1C), each of the plurality of struts having an adjustable length (see paragraph [0071]); an interface module (122) that is attached to one of the pair of rings (see Fig. 1C and paragraph [0095]), wherein the interface module is configured to be connected to the first motor and the second motor (see paragraphs [0071], [0074], [0075], [0083], [0103] and [0116] and Fig. 1C; each strut 100 comprises an actuator 104 that includes a motor and the interface module sends controlling signals to the actuator motors), and the interface module comprising a processor (see paragraph [0091]) configured to: control the first motor to adjust a length of a first strut of the plurality of struts (see paragraphs [0091], [0093], [0094], [0103]-[0105], and [0116]; interface module 122 may simultaneously control multiple struts 100 to adjust their lengths); and control the second motor to adjust a length of a second strut of the plurality of struts (see paragraphs [0091], [0093], [0094], [0103]-[0105], and [0116]; interface module 122 may simultaneously control multiple struts 100 to adjust their lengths).
Further regarding claim 11, Vikinsky is silent regarding the interface module being removably attachable. However, Ross discloses an external fixation device (50) in which a component (10) with an interface module (see paragraph [0032]) for controlling adjustment of the external fixation device is removably attachable to the device (via fitting 30, see paragraph [0035]). Regarding claim 12, Ross suggests wherein the interface module is configured to be detached from the bone fixation device when a treatment session is over (detached via fitting 30, see paragraph [0035]; see also Abstract, one tool used to adjust multiple struts, thus, must be removable from the struts, including when treatment session is over). Regarding claim 13, Ross suggests further comprising a connecting member (fitting 30, see paragraph [0035]; see also clip, paragraph [0064]), wherein the interface module is attached to and detached from the external fixation device using the connecting member (see paragraphs [0035] and [0064]). Regarding claim 14, Ross discloses wherein the connecting member comprises a clip (see paragraph [0064]). Additionally, it would have been prima facie obvious to make the clip “quick release” in order to allow a user to minimize the time necessary for connecting and releasing the tool/motor from the strut.
Further regarding claims 11-14, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the interface module be removably attachable to the ring of the bone fixation device in order to reduce the number of parts on the bone fixation device worn by the user by having the interface module removable from the device, and/or to allow for an interface module to be usable on multiple bone fixation devices by the having the module removably attachable to each device.
Further regarding claim 11, Vikinsky appears to disclose the interface module being electrically connected to the motors (see paragraphs [0103] and [0116]). Alternatively, Ross discloses an external fixator tool (10) wherein an interface module (34/20) is electrically connected to a motor (38) of the strut to control operation of the motor (see paragraph [0013]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the interface module be electrically connected to the motors to allow for the motors to be controlled directly by the interface module (see Ross, paragraph [0013]).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Vikinsky in view of Ross, and further in view of U.S. Patent No. 5,180,380 (Pursley).
Regarding claim 5, Vikinsky discloses that the interface module (122) uses wired or wireless means for communicating with an external controlling device, and it would be prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention for the interface module to use wired or wireless connecting members to connect to each of the first and second motors in order to allow for communication between the controller and the motors to enable the controller to simultaneously control multiple strut motors (see Vikinsky, paragraphs [0094] and [0096]).
Further regarding claim 5, Vikinsky is silent regarding the processor being further configured to generate an indication when the first or second connector is connected to the wrong motor. However, Pursley discloses a motorized orthopaedic system (see Abstract), wherein the system generates an indication if a motor is not functioning properly according to a controller’s instructions (see col. 6, lines 28-48). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the device of Vikinsky such that the processor is configured to generate an indication when a connector is connected to the wrong motor as Pursley suggests providing a notification to prevent a motor from operating improperly according to a controller’s instructions (see Pursley, col. 6, lines 28-48).
Claims 6, 9, 16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vikinsky in view of Ross, and further in view of U.S. Patent Application Publication No. 2010/0010576 (Skelton).
Regarding claims 6, 9, 16, and 19, Vikinsky is silent regarding wherein the processor is further configured to receive a treatment session delay request from a user of the bone fixation device (claims 6 and 16); wherein the processor is further configured to receive an indication from a user of the bone fixation device that indicates to postpone a treatment session (claims 9 and 19). However, Skelton discloses a system for delivering therapy from a medical device wherein the system is configured to receive a request/indication from a user to pause treatment (see paragraphs [0240] and [0250]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the processor of Vikinsky to be configured to receive a request/indication from a user to delay/postpone treatment as suggested by Skelton as the user may feel it is not safe or appropriate for the system to provide a treatment session, and accordingly would want a mechanism to prevent the treatment session from occurring.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Vikinsky in view of Ross, and further in view of U.S. Patent Application Publication No. 2006/0052782 (Morgan).
Regarding claims 7 and 17, Vikinsky is silent regarding wherein the processor is further configured to determine if one or more measured parameters remain within a treatment safety boundary. However, Morgan discloses an orthopedic implant (10) wherein the implant includes a sensor (50) that detects a parameter regarding a user's body adjacent the implant, wherein the sensor detects a body temperature (see paragraph [0032]), wherein, if the body temperature exceeds a predetermined value, a processor (100) is configured to send an inflammation alert to one or more of a user of the implant and a physician treating the user (see paragraphs [0037] and [0045]); and wherein the processor is further configured to compare the determined parameter to a stored range of values, and if the determined parameter is not within the range of values, the processor is configured to send an alert to one or more of the user of the bone fixation device and a physician treating the user (see paragraphs [0037] and [0045]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the device of Vikinsky to have a temperature sensor and a processor configured to send an alert for a an out of boundary temperature fever or infection (i.e., a type of inflammation) as suggested by Morgan in order to alert the user and/or doctor that the patient’s body may not be tolerating the bone fixation device well and needs medical attention.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Vikinsky in view of Ross, and further in view of U.S. Patent Publication No. 2007/0043310 (Trandafir) or U.S. Patent Application Publication No. 2007/0150026 (Bourget).
Regarding claims 8 or 18, Vikinsky is silent regarding wherein the processor is further configured to send a recommended body posture to a user of the bone fixation device. However, Trandafir discloses a system for delivering therapy to a patient that involves a processor configured to send a recommended body posture to the user in order for the therapy to be delivered effectively (see paragraphs [0025], [0048], [0055], and [0064]). Additionally, Bourget discloses a system for delivering treatment to a patient in which a processor is configured to recommend the user to assume a certain body posture in order to diagnose a problem that caused a therapy shutdown (see Bourget, paragraph [0073]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the process of Vikinsky to send a recommended body posture to a user of the bone fixation device in order to allow the patient to be best positioned to receive effective treatment, or to allow the system to diagnose a problem that caused a problematic therapeutic treatment session.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Vikinsky in view of Ross, and further in view of U.S. Patent Application Publication No. 2008/0051779 (Mackenzie).
Regarding claims 10 and 20, Vikinsky is silent regarding wherein the interface module comprises a force sensor that measures a force applied by one or more of the first motor or the second motor. However, Mackenzie discloses a bone lengthening system (see Abstract) wherein the system comprises a force sensor that measures a force applied by a motorized distractor (see paragraphs [0005], [0007], and [0027]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the device of Vikinsky to have the interface module comprises a force sensor that measures a force applied by the motor in order to allow the motor to be disabled if a predetermined threshold of force is reached, thus maintaining the safety of the patient (see Mackenzie, paragraph [0005]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12,220,250 (Cohen).
Although the claims at issue are not identical, they are not patentably distinct from each other because the difference between the application claims and the patent claims lies in the fact that the patent claims include the subject matter of the application claims, plus additional features. Thus, the invention of the patent claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the application claims are anticipated by the patent claims, they are not patentably distinct from the patent claims.
Claims 1 and 11 are each anticipated by claim 1 of Cohen.
Claims 1 and 11 are each anticipated by claim 6 of Cohen.
Response to Arguments
Applicant's arguments filed May 7, 2026 have been fully considered but they are not persuasive.
Double Patent Rejections
Applicant argues on page 6 of the Remarks that the double patenting rejection is premature, and the rejection be held in abeyance. However, only compliance with objections or requirements as to form not necessary for further consideration of the claims may be held in abeyance, and the rejection is maintained. See MPEP, Section 804.
103 Rejections
Applicant argues on page 7 of the Remarks that Ross fails to disclose the programmable tool 10 in Ross is removably attachable to a first ring; however, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ross is not relied on for disclosing an interface module being attachable to a ring; Vikinsky is relied on for disclosing this feature. Ross is relied on for suggesting an interface module tool being removably attachable from part of an external fixation device in order to allow the interface module to be usable on multiple devices and reduce the number of parts on the device worn by the user at all times. This suggestion from Ross is useful whether the interface module tool is attached to a strut or ring of an external fixation device.
Applicant argues on page 7 of the Remarks that the programmable tool 10 of Ross is not configured to be electrically connected to a first motor and a second motor, only mechanically connected; however, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). First, Vikinsky is relied on for disclosing the interface being electrically connected to the first and second motors (see paragraphs [0103] and [0116]), and Applicant does not provide reasoning how Vikinsky fails to disclose this feature; thus, Ross need not even be relied on for suggesting this feature. In the alternative, Ross discloses in paragraph [0013] that “[a] controller is in electrical communication with the data port, the signal-sensor, the power supply and the motor”; thus, Ross does suggest an interface module tool electrically connected to a motor.
Applicant argues on pages 7-8 of the Remarks that the programmable tool 10 of Ross does not have a processor configured to control a first motor and a second motor to adjust first and second strut lengths, respectively. However, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ross is not relied on for disclosing a processor configured to control a first motor and a second motor to adjust first and second strut lengths, respectively, the motors located externally of the interface module; Vikinsky is relied on for disclosing this feature. Ross is relied on for suggesting an interface module tool being removably attachable from part of an external fixation device in order to allow the interface module to be usable on multiple devices and reduce the number of parts on the device worn by the user at all times. This suggestion from Ross is useful whether the interface module tool includes a motor and a processor for controlling the motor, or whether the interface module tool includes a processor for controlling motors contained in an external fixation device.
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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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