DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 20, 2026 has been entered.
Claim Rejections - 35 USC § 102
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 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 1-3, 5, 10, 11, and 13-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by U.S. Patent Application Publication No. 2013/0201212 (Haskell) or, in the alternative, under 35 U.S.C. 103 as being obvious over Haskell in view of U.S. Patent Application Publication No. 2011/0313418 (Nikonavas).
Regarding claim 1, Haskell discloses a computer-implemented method comprising: receiving, using one or more graphical user interfaces of a computing system, configuration information associated with a fixation apparatus, the fixation apparatus including rings and struts (see Abstract, fixation apparatus is an external fixator including rings and struts), the configuration information comprising one or more geometric characteristics of one or more elements of the fixation apparatus (see paragraphs [0100]-[0106] and Fig. 12, e.g.); displaying, using the one or more graphical user interfaces, images of the fixation apparatus and the first and the second anatomical structure segments attached thereto (see paragraphs [0100]-[0101] and Fig. 12, e.g.); receiving, using the one or more graphical user interfaces, first image information comprising indications of one or more locations, within the images, of at least part of one or more elements of the fixation apparatus (see paragraph [0084] and Fig. 4, e.g.); receiving, using the one or more graphical user interfaces, second image information comprising indications of one or more locations, within the images, of at least part of the first and the second anatomical structure segments (see paragraph [0084] and Fig. 4, e.g.); providing, via the one or more graphical user interfaces, a control that allows user selection of an option to perform axial movement in an initial part of treatment over a specified duration (see paragraphs [0196] and [0207]-[0209], and Figs. 37A-40; see marked-up Fig. 37A below in which a “shorten” or “lengthen” option is provided in the graphical user interface that allows a user to selection an option to perform shortening or lengthening (i.e., axial movement) in an initial part of treatment; user can also set the number of days over which an initial step of treatment occurs); determining, by the computing system, manipulations to the fixation apparatus for correction of an anatomical structure deformity of the first and second anatomical structure segments, the manipulations comprising adjustments to the struts (see paragraphs [0192], [0194], and [0210], e.g.), wherein the determining, by the computing system, the manipulations is performed based, at least in part, on the user selection of the option to perform the axial movement in the initial part of the treatment over the specified duration (see paragraphs [0076], [0168]-[0171], [0191]-[0196], [0207]-[0209] and [0219] e.g.); and providing, by the computing system, to one or more users, indications of the manipulations to the fixation apparatus (see paragraphs [0192], [0194], and [0210], e.g.).
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Haskell appears to disclose determining, by the computing system, based at least in part on the configuration information, the first image information, and the second image information, positions and orientations of the first and the second anatomical structure segments in three-dimensional space (see Abstract, paragraphs [0100], [0136], [0142], and Figs. 37A-43). Alternatively, Nikonavas discloses a computer-implemented method for controlling manipulation of a fixation apparatus attached to bone segments, comprising: receiving first image information comprising indications of one or more locations, within the images, of at least part of one or more elements of the fixation apparatus (see paragraphs [0022]- [0025] and [0030]); receiving second image information comprising indications of one or more locations, within the images, of at least part of the first and the second anatomical structure segments (see paragraphs [0022]- [0025], [0046], and [0047]); determining, by the computing system, based at least in part on the configuration information, the first image information, and the second image information, positions and orientations of the first and the second anatomical structure segments in three-dimensional space (see Abstract and paragraphs [0025], [0027], [0046], [0052], and [0056]); determining, by the computing system, manipulations to the fixation apparatus for correction of the anatomical structure deformity, the manipulations comprising adjustments to the struts (see paragraphs [0052]-[0056]); and providing, by the computing system, to one or more users, indications of the manipulations to the fixation apparatus (see paragraphs [0052]-[0056]). 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 method of Haskell to include a 3D representation of the anatomical segments and a corresponding attached fixation apparatus in order to facilitate a user in determining the best treatment plan for a given patient by modeling possible corrective treatment plans on 3D representations of a patient’s anatomy.
Regarding claim 2, Haskell discloses wherein the configuration information comprises a length of one or more struts of the fixation apparatus (see paragraph [0101], [0138], [0148], and [0161], e.g.).
Regarding claim 3, Haskell discloses wherein the configuration information comprises indications of mounting points at which one or more struts are mounted (see paragraph [0101], e.g.).
Regarding claim 5, Haskell discloses further comprising providing, using the one or more graphical user interfaces, a graphical representation of the fixation apparatus based at least in part on the configuration information (see paragraphs [0100]-[0105] and Figs. 14A-14B, e.g.).
Regarding claim 10, Haskell discloses wherein the determining, by the computing system, the manipulations is performed based, at least in part, on a specified duration of treatment (see paragraphs [0205]-[0209], e.g.).
Regarding claim 11, Haskell discloses wherein the determining, by the computing system, the manipulations is performed based, at least in part, on a specified rate of distraction (see paragraphs [0196]-[0209], e.g.)
Regarding claim 13, Haskell discloses further comprising generating one or more graphical representations of a position and an orientation of the first and second anatomical structure segments and rings of the fixation apparatus (see Figs. 6-43, e.g.).
Regarding claim 14, Haskell discloses wherein the one or more graphical representations comprise day-by-day graphical representations of a position and an orientation of the first and second anatomical structure segments and the rings of the fixation apparatus throughout treatment for the anatomical structure deformity (see paragraph [0200] and Figs. 39A-39E, e.g.). Additionally, 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 use any desired day-by-day increments that allows a user to visualize a corrective treatment over time.
Regarding claim 15, Haskell discloses wherein the images comprise non-orthogonal images (see paragraphs [0084] and [0085], e.g.).
Regarding claim 21, Haskell discloses wherein the specific duration comprises a number of days (see paragraphs [0196] and [0207]-[0209], and Figs. 37A-40; user can set the number of days over which an initial step of treatment occurs).
Regarding claim 16, Haskell discloses a computing system (see paragraphs [0076] and [0078], e.g.) comprising: one or more processors (120); and one or more memories (130/150) having stored therein first instructions that, upon execution by the one or more processors, cause the computing system perform operations comprising: receiving, using one or more graphical user interfaces of the computing system, configuration information associated with a fixation apparatus, the fixation apparatus including rings and struts (see Abstract, fixation apparatus is an external fixator including rings and struts), the configuration information comprising one or more geometric characteristics of one or more elements of the fixation apparatus (see paragraphs [0100]-[0106] and Fig. 12, e.g.); displaying, using the one or more graphical user interfaces, images of the fixation apparatus and first and the second anatomical structure segments attached thereto (see paragraphs [0100]-[0101] and Fig. 12, e.g.); receiving, using the one or more graphical user interfaces, first image information comprising indications of one or more locations, within the images, of at least part of one or more elements of the fixation apparatus (see paragraph [0084] and Fig. 4, e.g.); receiving, using the one or more graphical user interfaces, second image information comprising indications of one or more locations, within the images, of at least part of the first and the second anatomical structure segments (see paragraph [0084] and Fig. 4, e.g.); providing, via the one or more graphical user interfaces, a control that allows user selection of an option to perform axial movement over a specified duration that comprises a number of days in an initial part of treatment (see paragraphs [0196] and [0207]-[0209], and Figs. 37A-40; see marked-up Fig. 37A below in which a “shorten” or “lengthen” option is provided in the graphical user interface that allows a user to selection an option to perform shortening or lengthening (i.e., axial movement) in an initial part of treatment; user can also set the number of days over which an initial step of treatment occurs); determining manipulations to the fixation apparatus for correction of an anatomical structure deformity of the first and second anatomical structure segments, the manipulations comprising adjustments to the struts (see paragraphs [0192], [0194], and [0210], e.g.), wherein the determining the manipulations is performed based, at least in part, on the user selection of the option to perform the axial movement in the initial part of the treatment (see paragraphs [0076], [0168]-[0171], [0191]-[0196], and [0219] e.g.); and providing, to one or more users, indications of the manipulations to the fixation apparatus (see paragraphs [0192], [0194], and [0210], e.g.).
Haskell appears to disclose determining, based at least in part on the configuration information, the first image information, and the second image information, positions and orientations of the first and the second anatomical structure segments in three-dimensional space (see Abstract, paragraphs [0100], [0136], [0142], and Figs. 37A-43). Alternatively, Nikonavas discloses a computer-implemented method for controlling manipulation of a fixation apparatus attached to bone segments, comprising: receiving first image information comprising indications of one or more locations, within the images, of at least part of one or more elements of the fixation apparatus (see paragraphs [0022]- [0025] and [0030]); receiving second image information comprising indications of one or more locations, within the images, of at least part of the first and the second anatomical structure segments (see paragraphs [0022]- [0025], [0046], and [0047]); determining, by the computing system, based at least in part on the configuration information, the first image information, and the second image information, positions and orientations of the first and the second anatomical structure segments in three-dimensional space (see Abstract and paragraphs [0025], [0027], [0046], [0052], and [0056]); determining, by the computing system, manipulations to the fixation apparatus for correction of the anatomical structure deformity, the manipulations comprising adjustments to the struts (see paragraphs [0052]-[0056]); and providing, by the computing system, to one or more users, indications of the manipulations to the fixation apparatus (see paragraphs [0052]-[0056]). 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 method of Haskell to include a 3D representation of the anatomical segments and a corresponding attached fixation apparatus in order to facilitate a user in determining the best treatment plan for a given patient by modeling possible corrective treatment plans on 3D representations of a patient’s anatomy.
Regarding claim 17, Haskell discloses wherein the configuration information comprises a length of one or more struts of the fixation apparatus (see paragraph [0101], [0138], [0148], and [0161], e.g.).
Regarding claim 18, Haskell discloses wherein the configuration information comprises indications of mounting points at which one or more struts are mounted (see paragraph [0101], e.g.).
Regarding claim 19, Haskell discloses wherein the images comprise non-orthogonal images (see paragraphs [0084] and [0085], e.g.).
Regarding claim 20, Haskell discloses one or more non-transitory computer-readable storage media (see paragraphs [0011] and [0076], e.g.) having stored thereon instructions that, upon execution by one or more computing devices, cause the one or more computing devices to perform operations comprising: receiving, using one or more graphical user interfaces of the one or more computing devices, configuration information associated with the fixation apparatus, the fixation apparatus including rings and struts (see Abstract, fixation apparatus is an external fixator including rings and struts), the configuration information comprising one or more geometric characteristics of one or more elements of the fixation apparatus (see paragraphs [0100]-[0106] and Fig. 12, e.g.); displaying, using the one or more graphical user interfaces, images of the fixation apparatus and first and the second anatomical structure segments attached thereto (see paragraphs [0100]-[0101] and Fig. 12, e.g.); receiving, using the one or more graphical user interfaces, first image information comprising indications of one or more locations, within the images, of at least part of one or more elements of the fixation apparatus (see paragraph [0084] and Fig. 4, e.g.); receiving, using the one or more graphical user interfaces, second image information comprising indications of one or more locations, within the images, of at least part of the first and the second anatomical structure segments (see paragraph [0084] and Fig. 4, e.g.); providing, via the one or more graphical user interfaces, a control that allows user selection of an option to perform axial movement over a specified duration in an initial part of treatment wherein the specific duration comprises a number of days (see paragraphs [0196] and [0207]-[0209], and Figs. 37A-40; see marked-up Fig. 37A below in which a “shorten” or “lengthen” option is provided in the graphical user interface that allows a user to selection an option to perform shortening or lengthening (i.e., axial movement) in an initial part of treatment; user can also set the number of days over which an initial step of treatment occurs); determining manipulations to the fixation apparatus for correction of the anatomical structure deformity of the first and the second anatomical structure segments, the manipulations comprising adjustments to the struts (see paragraphs [0192], [0194], and [0210], e.g.), wherein the determining the manipulations is performed based, at least in part, on the user selection of the option perform the axial movement in the initial part of the treatment (see paragraphs [0076], [0168]-[0171], [0191]-[0196], and [0219] e.g.); and providing, to one or more users, indications of the manipulations to the fixation apparatus (see paragraphs [0192], [0194], and [0210], e.g.).
Haskell appears to disclose determining, based at least in part on the configuration information, the first image information, and the second image information, positions and orientations of the first and the second anatomical structure segments in three-dimensional space (see Abstract, paragraphs [0100], [0136], [0142], and Figs. 37A-43). Alternatively, Nikonavas discloses a computer-implemented method for controlling manipulation of a fixation apparatus attached to bone segments, comprising: receiving first image information comprising indications of one or more locations, within the images, of at least part of one or more elements of the fixation apparatus (see paragraphs [0022]- [0025] and [0030]); receiving second image information comprising indications of one or more locations, within the images, of at least part of the first and the second anatomical structure segments (see paragraphs [0022]- [0025], [0046], and [0047]); determining, by the computing system, based at least in part on the configuration information, the first image information, and the second image information, positions and orientations of the first and the second anatomical structure segments in three-dimensional space (see Abstract and paragraphs [0025], [0027], [0046], [0052], and [0056]); determining, by the computing system, manipulations to the fixation apparatus for correction of the anatomical structure deformity, the manipulations comprising adjustments to the struts (see paragraphs [0052]-[0056]); and providing, by the computing system, to one or more users, indications of the manipulations to the fixation apparatus (see paragraphs [0052]-[0056]). 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 media of Haskell to include a 3D representation of the anatomical segments and a corresponding attached fixation apparatus in order to facilitate a user in determining the best treatment plan for a given patient by modeling possible corrective treatment plans on 3D representations of a patient’s anatomy.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Haskell and Nikonavas, and further in view of U.S. Patent Application Publication No. 2007/0055234 (McGrath).
Regarding claims 6 and 7, Haskell and Nikonavas fail to disclose or suggest wherein the graphical representation of the fixation apparatus includes color-coded graphical representations of struts (claim 6); wherein the color-coded graphical representations of the struts in the graphical representation of the fixation apparatus match a physical color-coding of the struts in the fixation apparatus (claim 7), though Haskell does suggest using color-coded graphical representations to facilitate viewing of images in a graphical user interface (see paragraphs [0087] and [0088], e.g.). Additionally, McGrath discloses an external fixation system including rings and struts, wherein struts may be physically color-coded (see paragraph [0040]). 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 include physically color-coded struts as suggested by McGrath in order to facilitate a user in distinguishing and keeping track of various struts as they are adjusted over time (see McGrath, paragraph [0040]). Additionally, 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 use color-coded graphical representations of the struts corresponding to the color-coded struts in order to facilitate tracking of the individual struts on the graphical user interface in addition to the physical world.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Haskell and Nikonavas, and further in view of U.S. Patent Application Publication No. 2010/0087819 (Mullaney).
Regarding claim 8, Haskell and Nikonavas fails to disclose or suggest wherein a reference ring of the fixation apparatus is non-orthogonal with respect to an anatomical structure on which it is mounted. However, Mullaney discloses a method for treating a fractured bone including a fixation apparatus (10) including a reference ring (12, 14) wherein it is disclosed that the reference ring may be non-orthogonal with respect to bone segments attached to the rings (see Mullaney, paragraph [0094]). 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 method of Haskell and Nikonavas such that a reference ring is non-orthogonal with respect to an anatomical structure on which it is mounted as suggested by Mullaney in order to allow a user to position the ring in a position that best facilitates healing of a fractured bone.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Haskell and Nikonavas, and further in view of U.S. Patent Application Publication No. 2016/0113681 (Singh).
Regarding claim 9, Haskell and Nikonavas fails to disclose or suggest wherein the determining, by the computing system, the manipulations is performed based, at least in part, on instructions to perform two adjustments per day. However, Singh suggests a method of adjusting a fixation apparatus wherein it is suggested that multiple adjustments per day be used (see paragraph [0054]). 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 method of Haskell and Nikonavas to allow multiple adjustments per day in order to allow the user to tailor the treatment plan over a desired timeframe, and because it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Haskell and Nikonavas, and further in view of U.S. Patent Application Publication No. 2009/0036892 (Karidis).
Regarding claim 9, Haskell and Nikonavas fails to disclose or suggest wherein the determining, by the computing system, the manipulations is performed based, at least in part, on instructions to perform two adjustments per day. However, Karidis suggests a method of adjusting a fixation apparatus wherein it is suggested that multiple adjustments per day be used (see paragraph [0054]). 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 method of Haskell and Nikonavas to allow multiple adjustments per day in order to allow the user to tailor the treatment plan over a desired timeframe, and because it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Haskell and Nikonavas, and further in view of U.S. Patent Application Publication No. 2013/0138017 (Jundt).
Regarding claim 12, Haskell and Nikonavas fail to disclose or suggest further comprising generating one or more alerts for one or more of the manipulations to the fixation apparatus that result in at least one strut movement of more than a threshold amount. However, Jundt discloses a bone distraction device (see Abstract) wherein it is suggested that excessive bone distraction rates will trigger an alarm alerting the user that an abnormal condition has occurred and the system should be shut down or fixed (see paragraph [0046]). 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 provide an alert when a threshold of desired strut movement is exceeded in order to alert the user to a potential problem in a corrective treatment plan that allows the user to address the problem before damage to the patient is done.
Response to Arguments
Applicant's arguments filed January 20, 2026 have been fully considered but they are not persuasive.
On pages 10-11 of the Remarks, Applicant argues that Haskell does not disclose “providing a control that allows user selection of an option to perform axial movement in an initial part of treatment over a specified duration” and “wherein the determining, by the computing system, the manipulations is performed based, at least in part, on the user selection of the option to perform the axial movement in the initial part of the treatment”. The examiner disagrees. As noted in marked-up Fig. 37A, the “SET CORRECTION TAB” 700 of the graphical user interface of Haskell has a “Shorten” or “Lengthen” option that allows the user to allow for axial movement during any phase of the treatment. Further, paragraphs [0196] and [0207]-[0209] make clear that the corrections can be broken up into multiple steps, and in each correction step (including an initial correction step) the user can individually set each parameter (including a shortening or lengthening axial movement and the number of days over which the step takes place). Whether the initial distraction to disengage bone fragments counts as an initial first step of treatment or not, Haskell still discloses allowing the user to break the treatment into steps, and set the duration of each step and whether it will involve shortening or lengthening axial movement. Thus, Haskell discloses “providing a control that allows user selection of an option to perform axial movement in an initial part of treatment over a specified duration”. Further, subsequent correction steps are performed based on previous correction steps (see paragraphs [0191]-[0209], e.g.), and thus, Haskell discloses “wherein the determining, by the computing system, the manipulations is performed based, at least in part, on the user selection of the option to perform the axial movement in the initial part of the treatment”.
Conclusion
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773