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 .
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 4, 6-11 and 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hossler U.S. Patent No. (4,699,130) in view of Chisena U.S. Patent No. (5,171,310) and evidenced by Kaufman et al. U.S. Publication No. (2009/0054818 A1).
With respect to claim 1, Hossler discloses an upper arm splint device (50, fig.4), comprising:
a rigid outer member or splint (as shown in the reproduced image of fig.4 below; the modular splint 14, comprises multiple segments of splints connected via Velcro, (abstract)) and ([Col.2], lines 46-52) configured to fit upon an outside of an upper arm and shoulder (as shown in fig.4); the rigid outer member or splint comprising plastic ([Col.4], lines 64-68, Each splint segment 14 and 16 is made from a strong, but lightweight plastic] and ([Col.3], lines 29-36, each splint 14 including the two sidewalls 42 is preferably made from a plastic material. A variety of known plastic materials such as ABS, polycarbonate and polystyrene would be acceptable];
a rigid inner member or splint (as shown in the reproduced image of fig.4 below; the modular splint 14, comprises multiple segments of splints connected via Velcro, (abstract)) configured to fit upon an inside of the upper arm (as shown in fig.4); the rigid inner member comprising plastic ([Col.4], lines 64-68, Each splint segment 14 and 16 is made from a strong, but lightweight plastic] and ([Col.3], lines 29-36, each splint 14 including the two sidewalls 42 is preferably made from a plastic material. A variety of known plastic materials such as ABS, polycarbonate and polystyrene would be acceptable];
a plurality of outer stabilization bladders or air cushions (40, see reproduced image of fig.3E below) coupled to the rigid outer member and capable of independent inflation; as shown in figs.(3C-E) each splint segment (14) of the multiple segments comprises an air cushion or bladder (40) on both sides of each segments (14); as shown in (fig.4, the embodiment drawn to the inventive concept of the instant application comprises three segments for the rigid outer member to which three air cushion or bladders are connected as shown in (fig.3E); as such, constitutes a plurality of outer stabilization bladders [outer is being interpreted as the outer surface of the upper and forearm, see the reproduced image of fig.4 below];
a plurality of inner stabilization bladders (40, see reproduced image of fig.3E below) coupled to the rigid inner member and capable of independent inflation via valve (44) and ([Col.3], lines 18-20, a one-way valve 44 is used to inflate air cushion 40); as shown in (fig.4, the embodiment drawn to the inventive concept of the instant application comprises three segments for the rigid inner member to which three air cushion or bladders (40) are connected as shown in (fig.3E); as such, constitutes a plurality of inner stabilization bladders [inner is being interpreted as the inner surface of the upper and forearm, see the reproduced image of fig.4 below];
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a plurality of bands or straps (18) connecting the rigid outer member to the rigid inner member (as shown in fig.4);
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Hossler substantially discloses the invention a claimed except wherein inflation of selected ones of the plurality of outer stabilization bladders and selected ones of the plurality of inner stabilization bladders provides a three-point fixation configured to align a fractured humerus.
Chisena however, teaches a method and apparatus (as shown in figs.1-12F) are provided for aligning and/or maintaining the reduction of fractures of long bones, to hasten the stimulation of the osteogenesis reaction, the cellular components of fracture healing, and/or the mitigation of pain associated with fractures (Abstract) comprising two soft-tissue deforming members (7A, 7B) being utilized reduction in the angulated humeral fracture ([Col.10], lines 66-68) and ([Col.11], lines 1-32). Chisena further teaches in ([Col.14], lines 39-68, “In order to "operate" the orthopaedic device 5 of the present invention, the cross-sectional diameter of the bracing system 6 is reduced by applying a hoop stress to the bracing structure 8 and tongue structure 9, i.e. by tightening strapping means 12A and 12B illustrated in FIGS. 6A through 6C. In response to the application of the hoop stress and consequential reduction in diameter of the bracing system 6 (i.e. from d.sub.1 to d.sub.2 as illustrated in FIGS. 3A and 4A), a distribution of radially directed force is applied over the soft-tissue deforming member 7 and the skin of the limb and about the angulated long bone fracture, so as to achieve both mechanical and biochemical functions through the gross "asymmetrical" deformation of the soft-tissues 4 surrounding the fracture site. The mechanical functions include: the establishment of a fixation of pressure at three points (i.e. "three-point fixation") along the fractured long bone for achieving closed reduction of the angulation thereof; tamponading the torn blood vessels at the fracture site; and local restriction of the microcirculation in the soft-tissues 4 deformed between the soft-tissue deforming member 7 and the apex of the fracture. The "beneficial" biochemical effects obtained through the application of the orthopaedic device 5 of the present invention, will be described hereinafter in detail, and notably, these beneficial biochemical changes in the soft-tissues underlying the soft-tissue deforming member 7, occur secondary to the mechanical functions described above”]. As regard the “selected ones” limitation, this is based on the location of the bone fracture, as discloses in Chisena in ([Col.15], lines 1-16, Chisena teaches “In order to carry out mechanical functions described above, the radially directed force distribution provided by the bracing system 6, is transmitted from the soft-tissue deforming member 7, through the soft-tissues, and results in application of pressure along the fractured humerus at three points which are generally indicated in FIG. 3 by P.sub.1, P.sub.2 and P.sub.3, the first, second and third contact points, respectively. Initially, the three pressure points, referred to as "three point fixation," is characterized by three bound force vectors P.sub.1, P.sub.2, P.sub.3 each having a magnitude which is largest at the time when the angulation .alpha..sub.o is largest, and the magnitude tends to decrease over time as the angulation is further reduced, and bone fragments align. In the equilibrium configuration, the magnitude of these force vectors may wax and wane in response to muscle contraction of the soft-tissues”.
While Chisena did not teach the use of bladders, it is well known in the art to utilize a variety of other devices for providing a three-point fixation as evidenced in Kaufman, in para [0053, “While in the preferred embodiment, the anterior pressure pads and the posterior pressure pads are inflatable air bladders, the anterior pressure pads and the posterior pressure pads may also comprise liquid-filled sacs, gel-filled sacs or foam-type (e.g., polyurethane) pads”]; Kaufmann further provide evidenced of the use of bladders for performing the function of providing a three-point fixation in a splint for stabilizing the anatomy [0013]; in para [0056, next, a fixation plan is determined. When the thoracolumbosacral orthosis 10 is to be used for the treatment of back pain or for post-surgical treatment, a three-point fixation in the sagittal plane including (i) ASIS bilateral fixation, (ii) sternal fixation, and (iii) transscapular-interscapular and/or lumbar fixation is typically selected. This type of three-point fixation can be implemented in the thoracolumbosacral orthosis 10 by: (1) inflating the air bladders comprising the pair of anterior superior iliac spine (ASIS) pads 58L and 58R on the interior surface 25 of the anterior shell 20 such that the pair of anterior superior iliac spine (ASIS) pads 58L and 58R extends away from the interior surface 25 to create pressure pads that extends inwardly toward the patient's torso when the thoracolumbosacral orthosis 10 is placed on the patient; (2) inflating the air bladder comprising the sternal-clavicular pad 52 on the interior surface 25 of the anterior shell 20 such that the sternal-clavicular pad 52 extends away from the interior surface 25 to create a pressure pad that extends inwardly toward the patient's torso; (3) inflating the air bladders comprising the transscapular-interscapular pad 62 and/or the lumbar pad 69 on the interior surface 35 of the posterior shell 30 such that the transscapular-interscapular pad 62 and/or the lumbar pad 69 extends away from the interior surface 35 to create a pressure pad that extends inwardly toward the patient's torso. Of course, any other anterior or posterior pressure pads may be inflated as needed under the patient treatment program. For example, the paraspinal pads 68L and 68R may be inflated. The anterior shell 20 and the posterior shell 30 are then secured to the patient's torso as shown in FIGS. 1-3 using the fastening system 40. Alternatively, the anterior shell 20 and the posterior shell 30 may be secured to the patient's torso first and then the air bladders for the anterior pressure pads and the posterior pressure pads may be inflated thereafter for custom fitting to a patient's torso].
In view of the teachings of Chisena, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the selected ones of the plurality of outer stabilizing bladders and the selected ones of the plurality of inner stabilizing bladders in like manner, for providing a three-point fixation configured to align a fractured humerus to reduce and maintain angulation of the fracture; as a result of the local restriction of the blood transport through the microcirculation, healing of the fracture is stimulated and pain associated with the fracture is mitigated. In addition, torn blood vessels at the fracture site are physically tamponaded and thereby reduce bleeding from the torn blood vessels (Abstract of Chisena).
With respect to claim 4, the combination of Hossler/Chisena substantially discloses the invention as claimed. Hossler further discloses the rigid outer member and/or the rigid inner member comprises plastic ([Col.3], lines 29-36, each splint 14 including the two sidewalls 42 is preferably made from a plastic material. A variety of known plastic materials such as ABS, polycarbonate and polystyrene would be acceptable).
With respect to claim 6, the combination of Hossler/Chisena substantially discloses the invention as claimed. Hossler further discloses the plurality of bands or straps (18) are coupled to the rigid outer member and are configured for subsequent connection to the rigid inner member (as shown in fig.4).
With respect to claim 7, the combination of Hossler/Chisena substantially discloses the invention as claimed. Hossler further discloses the plurality of bands or straps (18) are coupled to the rigid inner member and are configured for subsequent connection to the rigid outer member (as shown in fig.4).
With respect to claim 8, the combination of Hossler/Chisena substantially discloses the invention as claimed. Hossler further discloses the splint device is configured to fit around an upper arm of a wearer having a broken humerus bone ([Col.1], lines 52-55, the twelve inch segments are useful for setting long bones, such as found in the arms and legs) and ([Col.4], lines 50-52, for example, FIG. 4 illustrates the use of the system 10 in the context of a probable fracture of the upper arm 48] and ([Col.4], lines 55-57, it provides rigidity, thereby eliminating unwanted movement of injured and/or tender tissue, bones and joints].
With respect to claim 9, the combination of Hossler/Chisena substantially discloses the invention as claimed. Hossler further inherently discloses inflation of one or more bladders or air cushion (40) of the plurality of outer stabilization bladders and/or the plurality of inner stabilization bladders or air cushion (40) causes the broken humerus bone to properly align to facilitate proper healing ([Col.4], lines 55-57, it provides rigidity, thereby eliminating unwanted movement of injured bones and joints, which implied that the device perform the function of causing the broken humerus bone to properly align to facilitate proper healing].
With respect to claim 10, the combination of Hossler/Chisena substantially discloses the invention as claimed. Hossler further discloses inflation of two bladders of the plurality of outer stabilization bladders or air cushions (40) and inflation of one bladder of the plurality of inner stabilization bladders or air cushions (40) to properly align the broken humerus bone to facilitate proper healing ([Col.4], lines 55-57, it provides rigidity, thereby eliminating unwanted movement of injured bones and joints, which implied that the device perform the function of causing the broken humerus bone to properly align to facilitate proper healing]. Hossler did not explicitly discloses the bladders provides a three-point fixation.
Chisena however, teaches a method and apparatus (as shown in figs.1-12F) are provided for aligning and/or maintaining the reduction of fractures of long bones, to hasten the stimulation of the osteogenesis reaction, the cellular components of fracture healing, and/or the mitigation of pain associated with fractures (Abstract) comprising two soft-tissue deforming members (7A, 7B) being utilized reduction in the angulated humeral fracture ([Col.10], lines 66-68) and ([Col.11], lines 1-32). Chisena further teaches in ([Col.14], lines 39-68, “In order to "operate" the orthopaedic device 5 of the present invention, the cross-sectional diameter of the bracing system 6 is reduced by applying a hoop stress to the bracing structure 8 and tongue structure 9, i.e. by tightening strapping means 12A and 12B illustrated in FIGS. 6A through 6C. In response to the application of the hoop stress and consequential reduction in diameter of the bracing system 6 (i.e. from d.sub.1 to d.sub.2 as illustrated in FIGS. 3A and 4A), a distribution of radially directed force is applied over the soft-tissue deforming member 7 and the skin of the limb and about the angulated long bone fracture, so as to achieve both mechanical and biochemical functions through the gross "asymmetrical" deformation of the soft-tissues 4 surrounding the fracture site. The mechanical functions include: the establishment of a fixation of pressure at three points (i.e. "three-point fixation") along the fractured long bone for achieving closed reduction of the angulation thereof; tamponading the torn blood vessels at the fracture site; and local restriction of the microcirculation in the soft-tissues 4 deformed between the soft-tissue deforming member 7 and the apex of the fracture. The "beneficial" biochemical effects obtained through the application of the orthopaedic device 5 of the present invention, will be described hereinafter in detail, and notably, these beneficial biochemical changes in the soft-tissues underlying the soft-tissue deforming member 7, occur secondary to the mechanical functions described above”]. As regard the “selected ones” limitation, this is based on the location of the bone fracture, as discloses in Chisena in ([Col.15], lines 1-16, Chisena teaches “In order to carry out mechanical functions described above, the radially directed force distribution provided by the bracing system 6, is transmitted from the soft-tissue deforming member 7, through the soft-tissues, and results in application of pressure along the fractured humerus at three points which are generally indicated in FIG. 3 by P.sub.1, P.sub.2 and P.sub.3, the first, second and third contact points, respectively. Initially, the three pressure points, referred to as "three point fixation," is characterized by three bound force vectors P.sub.1, P.sub.2, P.sub.3 each having a magnitude which is largest at the time when the angulation .alpha..sub.o is largest, and the magnitude tends to decrease over time as the angulation is further reduced, and bone fragments align. In the equilibrium configuration, the magnitude of these force vectors may wax and wane in response to muscle contraction of the soft-tissues”.
While Chisena did not teach the use of bladders, it is well known in the art to utilize a variety of other devices for providing a three-point fixation as evidenced in Kaufman, in para [0053, “While in the preferred embodiment, the anterior pressure pads and the posterior pressure pads are inflatable air bladders, the anterior pressure pads and the posterior pressure pads may also comprise liquid-filled sacs, gel-filled sacs or foam-type (e.g., polyurethane) pads”]; Kaufmann further provide evidenced of the use of bladders for performing the function of providing a three-point fixation in a splint for stabilizing the anatomy [0013]; in para [0056, next, a fixation plan is determined. When the thoracolumbosacral orthosis 10 is to be used for the treatment of back pain or for post-surgical treatment, a three-point fixation in the sagittal plane including (i) ASIS bilateral fixation, (ii) sternal fixation, and (iii) transscapular-interscapular and/or lumbar fixation is typically selected. This type of three-point fixation can be implemented in the thoracolumbosacral orthosis 10 by: (1) inflating the air bladders comprising the pair of anterior superior iliac spine (ASIS) pads 58L and 58R on the interior surface 25 of the anterior shell 20 such that the pair of anterior superior iliac spine (ASIS) pads 58L and 58R extends away from the interior surface 25 to create pressure pads that extends inwardly toward the patient's torso when the thoracolumbosacral orthosis 10 is placed on the patient; (2) inflating the air bladder comprising the sternal-clavicular pad 52 on the interior surface 25 of the anterior shell 20 such that the sternal-clavicular pad 52 extends away from the interior surface 25 to create a pressure pad that extends inwardly toward the patient's torso; (3) inflating the air bladders comprising the transscapular-interscapular pad 62 and/or the lumbar pad 69 on the interior surface 35 of the posterior shell 30 such that the transscapular-interscapular pad 62 and/or the lumbar pad 69 extends away from the interior surface 35 to create a pressure pad that extends inwardly toward the patient's torso. Of course, any other anterior or posterior pressure pads may be inflated as needed under the patient treatment program. For example, the paraspinal pads 68L and 68R may be inflated. The anterior shell 20 and the posterior shell 30 are then secured to the patient's torso as shown in FIGS. 1-3 using the fastening system 40. Alternatively, the anterior shell 20 and the posterior shell 30 may be secured to the patient's torso first and then the air bladders for the anterior pressure pads and the posterior pressure pads may be inflated thereafter for custom fitting to a patient's torso].
In view of the teachings of Chisena, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the selected ones of the plurality of outer stabilizing bladders and the selected ones of the plurality of inner stabilizing bladders in like manner, for providing a three-point fixation configured to align a fractured humerus to reduce and maintain angulation of the fracture; as a result of the local restriction of the blood transport through the microcirculation, healing of the fracture is stimulated and pain associated with the fracture is mitigated. In addition, torn blood vessels at the fracture site are physically tamponaded and thereby reduce bleeding from the torn blood vessels (Abstract of Chisena).
With respect to claim 11, the combination of Hossler/Chisena substantially discloses the invention as claimed. Hossler further discloses inflation of two bladders of the plurality of inner stabilization bladders or air cushion (40) and inflation of one bladder of the plurality of outer stabilization bladders or air cushion (40) provides a three-point fixation to properly align the broken humerus bone to facilitate proper healing ([Col.4], lines 55-57, it provides rigidity, thereby eliminating unwanted movement of injured bones and joints, which implied that the device perform the function of causing the broken humerus bone to properly align to facilitate proper healing]. Hossler did not explicitly discloses the bladders provides a three-point fixation.
Chisena however, teaches a method and apparatus (as shown in figs.1-12F) are provided for aligning and/or maintaining the reduction of fractures of long bones, to hasten the stimulation of the osteogenesis reaction, the cellular components of fracture healing, and/or the mitigation of pain associated with fractures (Abstract) comprising two soft-tissue deforming members (7A, 7B) being utilized reduction in the angulated humeral fracture ([Col.10], lines 66-68) and ([Col.11], lines 1-32). Chisena further teaches in ([Col.14], lines 39-68, “In order to "operate" the orthopaedic device 5 of the present invention, the cross-sectional diameter of the bracing system 6 is reduced by applying a hoop stress to the bracing structure 8 and tongue structure 9, i.e. by tightening strapping means 12A and 12B illustrated in FIGS. 6A through 6C. In response to the application of the hoop stress and consequential reduction in diameter of the bracing system 6 (i.e. from d.sub.1 to d.sub.2 as illustrated in FIGS. 3A and 4A), a distribution of radially directed force is applied over the soft-tissue deforming member 7 and the skin of the limb and about the angulated long bone fracture, so as to achieve both mechanical and biochemical functions through the gross "asymmetrical" deformation of the soft-tissues 4 surrounding the fracture site. The mechanical functions include: the establishment of a fixation of pressure at three points (i.e. "three-point fixation") along the fractured long bone for achieving closed reduction of the angulation thereof; tamponading the torn blood vessels at the fracture site; and local restriction of the microcirculation in the soft-tissues 4 deformed between the soft-tissue deforming member 7 and the apex of the fracture. The "beneficial" biochemical effects obtained through the application of the orthopaedic device 5 of the present invention, will be described hereinafter in detail, and notably, these beneficial biochemical changes in the soft-tissues underlying the soft-tissue deforming member 7, occur secondary to the mechanical functions described above”]. As regard the “selected ones” limitation, this is based on the location of the bone fracture, as discloses in Chisena in ([Col.15], lines 1-16, Chisena teaches “In order to carry out mechanical functions described above, the radially directed force distribution provided by the bracing system 6, is transmitted from the soft-tissue deforming member 7, through the soft-tissues, and results in application of pressure along the fractured humerus at three points which are generally indicated in FIG. 3 by P.sub.1, P.sub.2 and P.sub.3, the first, second and third contact points, respectively. Initially, the three pressure points, referred to as "three point fixation," is characterized by three bound force vectors P.sub.1, P.sub.2, P.sub.3 each having a magnitude which is largest at the time when the angulation .alpha..sub.o is largest, and the magnitude tends to decrease over time as the angulation is further reduced, and bone fragments align. In the equilibrium configuration, the magnitude of these force vectors may wax and wane in response to muscle contraction of the soft-tissues”.
While Chisena did not teach the use of bladders, it is well known in the art to utilize a variety of other devices for providing a three-point fixation as evidenced in Kaufman, in para [0053, “While in the preferred embodiment, the anterior pressure pads and the posterior pressure pads are inflatable air bladders, the anterior pressure pads and the posterior pressure pads may also comprise liquid-filled sacs, gel-filled sacs or foam-type (e.g., polyurethane) pads”]; Kaufmann further provide evidenced of the use of bladders for performing the function of providing a three-point fixation in a splint for stabilizing the anatomy [0013]; in para [0056, next, a fixation plan is determined. When the thoracolumbosacral orthosis 10 is to be used for the treatment of back pain or for post-surgical treatment, a three-point fixation in the sagittal plane including (i) ASIS bilateral fixation, (ii) sternal fixation, and (iii) transscapular-interscapular and/or lumbar fixation is typically selected. This type of three-point fixation can be implemented in the thoracolumbosacral orthosis 10 by: (1) inflating the air bladders comprising the pair of anterior superior iliac spine (ASIS) pads 58L and 58R on the interior surface 25 of the anterior shell 20 such that the pair of anterior superior iliac spine (ASIS) pads 58L and 58R extends away from the interior surface 25 to create pressure pads that extends inwardly toward the patient's torso when the thoracolumbosacral orthosis 10 is placed on the patient; (2) inflating the air bladder comprising the sternal-clavicular pad 52 on the interior surface 25 of the anterior shell 20 such that the sternal-clavicular pad 52 extends away from the interior surface 25 to create a pressure pad that extends inwardly toward the patient's torso; (3) inflating the air bladders comprising the transscapular-interscapular pad 62 and/or the lumbar pad 69 on the interior surface 35 of the posterior shell 30 such that the transscapular-interscapular pad 62 and/or the lumbar pad 69 extends away from the interior surface 35 to create a pressure pad that extends inwardly toward the patient's torso. Of course, any other anterior or posterior pressure pads may be inflated as needed under the patient treatment program. For example, the paraspinal pads 68L and 68R may be inflated. The anterior shell 20 and the posterior shell 30 are then secured to the patient's torso as shown in FIGS. 1-3 using the fastening system 40. Alternatively, the anterior shell 20 and the posterior shell 30 may be secured to the patient's torso first and then the air bladders for the anterior pressure pads and the posterior pressure pads may be inflated thereafter for custom fitting to a patient's torso].
In view of the teachings of Chisena, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the selected ones of the plurality of outer stabilizing bladders and the selected ones of the plurality of inner stabilizing bladders in like manner, for providing a three-point fixation configured to align a fractured humerus to reduce and maintain angulation of the fracture; as a result of the local restriction of the blood transport through the microcirculation, healing of the fracture is stimulated and pain associated with the fracture is mitigated. In addition, torn blood vessels at the fracture site are physically tamponaded and thereby reduce bleeding from the torn blood vessels (Abstract of Chisena).
With respect to claim 13, regarding the method step claimed, to the extent that the prior art apparatus meets the structural limitations of the apparatus as claimed (see rejection to claim 1), it will inherently perform the method steps as claimed. Furthermore, it has been held that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of anticipation has been established. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986) and In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); (under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device) see MPEP 2112.01(1), as such, the combination of Hossler/Chisena discloses a method of stabilizing a broken humerus bone, comprising the steps of: positioning the upper arm splint device of claim 1 about an upper arm of a user; and inflating one or more bladders of the plurality of outer stabilization bladders and/or the plurality of inner stabilization bladders to cause the broken humerus bone to properly align to facilitate proper healing.
With respect to claim 14, the combination of Hossler/Chisena substantially discloses the invention as claimed except the step of inflating is performed to inflate two bladders of the plurality of outer stabilization bladders and to inflate one bladder of the plurality of inner stabilization bladders to provide a three-point fixation to properly align the broken humerus bone to facilitate proper healing; however, based on the location of the humerus bone fracture, it would have been obvious to one of ordinary skill in the art to selectively inflate two bladders of the plurality of outer stabilization bladders and to inflate one bladder of the plurality of inner stabilization bladders in order to provide the most appropriate bracing contour for embracing a fractured long bone so as to maximally control the alignment of the fracture and therewhile stimulate its healing; it would have been obvious to try; choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success which is to provide a three-point fixation to properly align the broken humerus bone to facilitate proper healing.
With respect to claim 15, the combination of Hossler/Chisena substantially discloses the invention as claimed except the step of inflating is performed to inflate two bladders of the plurality of inner stabilization bladders and to inflate one bladder of the plurality of outer stabilization bladders to provide a three-point fixation to properly align the broken humerus bone to facilitate proper healing; however, based on the location of the humerus bone fracture, it would have been obvious to one of ordinary skill in the art to selectively inflate two bladders of the plurality of inner stabilization bladders and to inflate one bladder of the plurality of outer stabilization bladders in order to provide the most appropriate bracing contour for embracing a fractured long bone so as to maximally control the alignment of the fracture and therewhile stimulate its healing; it would have been obvious to try; choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success which is to provide a three-point fixation to properly align the broken humerus bone to facilitate proper healing.
With respect to claim 16, the combination of Hossler/Chisena substantially discloses the invention as claimed except comprising the step of: rotating the rigid outer member and the rigid inner member radially at or about 90° around the shoulder/arm to accommodate stabilization for humeral breaks that occur in different axes/planes; however, as shown in (fig.4) and [(Abstract, the modular splint system includes segments that are connectable to each other with a velcro.RTM.-like material. Multiple segments can be connected to each other so as to form an elongated splint)]; in addition, Hossler discloses in ([Col.4], lines 47-52, One of the major advantages of the present invention lies in its adaptability. The system 10 can be employed to accommodate substantially all arm and leg injuries of varying degrees of seriousness. For example, FIG. 4 illustrates the use of the system 10 in the context of a probable fracture of the upper arm 48); since the splints are multiple segments connected via hook and loop fastener, one of ordinary skill in the art is capable of manipulating the splint such that the rigid outer member and the rigid inner member are configured to rotate radially at or about 90° around the shoulder/arm to accommodate stabilization for humeral breaks that occur in different axes/planes in order to promote healing of the humerus.
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Hossler/Chisena as applied to claim 1 above, and further in view of Carlin U.S. Patent No. (8,919,346 B2).
With respect to claim 2, the combination of Hossler/Chisena substantially discloses the invention as claimed except the rigid outer member is capable of inflation, and wherein the rigid outer member becomes rigid upon inflation.
Carlin however, teaches a forearm and hand positioning device according to a preferred embodiment of the invention comprises a first inflatable air bladder (4, fig.1) longitudinally extending with an upper surface that, when the first air bladder is inflated, supports the forearm and hand of a patient with a radial artery of the patient remaining accessible to an operator. A second air bladder or outer rigid member (5, fig.1; becomes rigid when inflated) of the device longitudinally extends beneath and is connected to the first air bladder and is configured when the second air bladder is inflated, to elevate the first air bladder and a forearm and hand supported on the first air bladder to a comfortable working height for an operator above a support for the patient's arm ([Col.1], lines 33-44); the first air bladder 4 is longitudinally extending in the direction of arrow A-A in FIG. 1, and has an upper surface 6 that, when the first air bladder is inflated, supports and tightens around the arm as shown in FIG. 2 to secure the arm in a position in the device. The second air bladder 5 or outer rigid member [becomes rigid when inflated] is longitudinally extending beneath and connected to the first air bladder and configured, when the second air bladder is inflated, to elevate the arm above the support 13 to comfortable working height for the operator. The first and second air bladders are separately inflatable using compressed air introduced through respective air valves 7 and 8 shown schematically in FIG. 1. The extent of inflation of air bladder 5 can be varied for adjusting the height the arm is supported above the cath arm board 13 independently of positioning tightness of the air bladder 4 on the arm. Three Velcro.RTM. straps 9 on the device, only two of which are shown in the drawings, releasably secure the hand, the proximal forearm and the upper arm near the bicep to the device ([Col.2], lines 36-53).
In view of the teachings of Carlin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the rigid outer member of Hossler/Chisena, in like manner, such that the rigid outer member becomes rigid when inflated in order to achieve a comfortable working height for shoulder of the user.
With respect to claim 3, the combination of Hossler/Chisena substantially discloses the invention as claimed except the rigid inner member is capable of inflation, and wherein the rigid inner member becomes rigid upon inflation.
Carlin however, teaches a forearm and hand positioning device according to a preferred embodiment of the invention comprises a first inflatable air bladder or inner rigid member (4, fig.1; becomes rigid when inflated) longitudinally extending with an upper surface that, when the first air bladder is inflated, supports the forearm and hand of a patient with a radial artery of the patient remaining accessible to an operator. A second air bladder or outer rigid member (5, fig.1) of the device longitudinally extends beneath and is connected to the first air bladder and is configured when the second air bladder is inflated, to elevate the first air bladder and a forearm and hand supported on the first air bladder to a comfortable working height for an operator above a support for the patient's arm ([Col.1], lines 33-44); the first air bladder 4 or inner rigid member [becomes rigid when inflated] is longitudinally extending in the direction of arrow A-A in FIG. 1, and has an upper surface 6 that, when the first air bladder is inflated, supports and tightens around the arm as shown in FIG. 2 to secure the arm in a position in the device. The second air bladder 5 or outer rigid member is longitudinally extending beneath and connected to the first air bladder and configured, when the second air bladder is inflated, to elevate the arm above the support 13 to comfortable working height for the operator. The first and second air bladders are separately inflatable using compressed air introduced through respective air valves 7 and 8 shown schematically in FIG. 1. The extent of inflation of air bladder 5 can be varied for adjusting the height the arm is supported above the cath arm board 13 independently of positioning tightness of the air bladder 4 on the arm. Three Velcro.RTM. straps 9 on the device, only two of which are shown in the drawings, releasably secure the hand, the proximal forearm and the upper arm near the bicep to the device ([Col.2], lines 36-53).
In view of the teachings of Carlin, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the rigid inner member of Hossler/Chisena, in like manner, such that the rigid inner member becomes rigid when inflated in order to achieve a comfortable working height for an operator above a support for the patient's arm ([Col.1], lines 40-44) of Carlin.
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hossler/Chisena as applied to claim 1 above, and further in view of Eriksson U.S. Publication No. (2016/0081843 A1).
With respect to claim 5, the combination of Hossler/Chisena substantially discloses the invention as claimed except the rigid outer member and/or the rigid inner member comprises metal.
Eriksson however, teaches a splint (110 or 210, figs.3 and 10) made of a metal material [0084]-[0085] and [0097].
In view of the teachings of Eriksson, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the rigid outer member and/or the rigid inner member of Hossler/Chisena to comprise metal in order to conform to the anatomy of the user [0085] of Eriksson.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Hossler/Chisena.
With respect to claim 12, Hossler substantially discloses the invention as claimed but did not explicitly discloses the rigid outer member and the rigid inner member are configured to rotate radially at or about 90° around the shoulder/arm to accommodate stabilization for humeral breaks that occur in different axes/planes, however, as shown in (fig.4) and [(Abstract, the modular splint system includes segments that are connectable to each other with a velcro.RTM.-like material. Multiple segments can be connected to each other so as to form an elongated splint)]; in addition, Hossler discloses in ([Col.4], lines 47-52, One of the major advantages of the present invention lies in its adaptability. The system 10 can be employed to accommodate substantially all arm and leg injuries of varying degrees of seriousness. For example, FIG. 4 illustrates the use of the system 10 in the context of a probable fracture of the upper arm 48); since the splints are multiple segments connected via hook and loop fastener, one of ordinary skill in the art is capable of manipulating the splint such that the rigid outer member and the rigid inner member are configured to rotate radially at or about 90° around the shoulder/arm to accommodate stabilization for humeral breaks that occur in different axes/planes in order to promote healing of the humerus.
Response to Arguments
Applicant’s arguments, see pages 1-9, filed 06/15/2026, with respect to the rejection(s) of claim(s) 1, 4, 6-11 and 13 under 35 U.S.C. 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Hossler in view of Chisena.
In response to applicant's argument that Hossler is directed generally to a modular splint system for immobilization of injured limbs, while Carlin is directed to a forearm and hand positioning device used to support a patient's arm during a medical procedure. Carlin's inflatable support members are used to elevate and position an arm at a desired working height for an operator, not to create corrective forces for fracture reduction or to establish a three-point fixation arrangement. Nothing in Carlin teaches or suggests selective inflation of stabilization bladders positioned on opposite sides of a fractured humerus, nor does Carlin teach or suggest generating a three-point fixation configured to align a fractured humerus. The Office Action identifies no teaching in either reference that would have motivated a person of ordinary skill in the art to modify Hossler's modular splint system to arrive at Applicant's claimed humeral fracture alignment device., the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Applicant further argues Applicant further respectfully traverses the rejection of claim 12 under 35 U.S.C. §103 as allegedly obvious over Hossler. Claim 12 recites that the rigid outer member and the rigid inner member are configured to rotate radially at or about 90° around the shoulder/arm to accommodate stabilization for humeral breaks that occur in different axes or planes. The Office Action acknowledges that Hossler does not expressly disclose this feature but concludes that because Hossler employs modular splint segments connected by hook-and-loop fasteners, a person of ordinary skill in the art would have been capable of manipulating the splint to achieve the claimed rotational configuration.
Applicant respectfully submits that the fact that a device may be physically manipulated in some manner does not establish that the device is configured to perform the specific function recited in the claim. Claim 12 requires a configuration that permits radial repositioning of the outer and inner members approximately 90° around the shoulder and upper arm SO that stabilization forces may be applied in different anatomical planes depending upon the orientation of the humeral fracture. The Office Action identifies no disclosure in Hossler of such a configuration, no disclosure of treating fractures occurring in different anatomical planes by repositioning support members, and no disclosure that the splint segments are intended to be rotated relative to one another to alter the direction of fixation forces.
This is not found to be persuasive as the limitation is broad and Applicant did not claimed a specific device or structure for carrying out this specific function; since the modular splint system includes segments that are connectable to each other with a velcro.RTM.-like material. Multiple segments can be connected to each other so as to form an elongated splint)]; in addition, Hossler discloses in ([Col.4], lines 47-52, One of the major advantages of the present invention lies in its adaptability. The system 10 can be employed to accommodate substantially all arm and leg injuries of varying degrees of seriousness. For example, FIG. 4 illustrates the use of the system 10 in the context of a probable fracture of the upper arm 48); since the splints are multiple segments connected via hook and loop fastener, one of ordinary skill in the art is capable of manipulating the splint such that the rigid outer member and the rigid inner member are configured to rotate radially at or about 90° around the shoulder/arm to accommodate stabilization for humeral breaks that occur in different axes/planes in order to promote healing of the humerus.
The amendment to claim 1 overcome the 35 U.S.C. 112(b) rejections (that applied to claims 2-13 based on dependency), therefore, the rejection has been withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786
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