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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “rigid” in claim 1-5, 7 and 12-13 is a relative term which renders the claim indefinite. The term “rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 6 and 8-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter since they depend directly or indirectly on rejected base claim 1 and therefore, contain the same deficiencies.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 4, 6-11 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hossler U.S. Patent No. (4,699,130) 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); Note: as regard to the term “rigid”; Hossler discloses in ([Col.4], lines 53-57, “…The invention just described has a number of useful characteristics: 1. It provides rigidity, thereby eliminating unwanted movement of injured and/or tender tissue, bones and joints…”]; Furthermore, the outer member or splint is made from material that would render it rigid as set forth in ([Col.3], lines 29-36];
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); Note: as regard to the term “rigid”; Hossler discloses in ([Col.4], lines 53-57, “…The invention just described has a number of useful characteristics: 1. It provides rigidity, thereby eliminating unwanted movement of injured and/or tender tissue, bones and joints…”]; Furthermore, the outer member or splint is made from material that would render it rigid as set forth in ([Col.3], lines 29-36];
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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and;
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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With respect to claim 4, Hossler 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, Hossler 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, Hossler 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, Hossler 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, Hossler 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, Hossler inherently 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) 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]. The concept of “a three-point fixation” is evidenced by Kaufman et al. who discloses in [0056, “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 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]; in this instance, the plurality of bladders or inflatable cushion (40) position at the upper arm in spaced relation when inflated will (1) extends inwardly toward the patient’s torso”]; in this instance, inflating the bladders or air cushions (40) extends away from the interior surface of the rigid outer/inner member and extends inwardly toward the patient's torso [upper arm where the broken humerus is located] when placed on the patient as treatment for aligning the broken humerus bone of the user to facilitate proper healing.
With respect to claim 11, Hossler inherently 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]. The concept of “a three-point fixation” is evidenced by Kaufman et al. who discloses in [0056, 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 ads 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]; in this instance, the plurality of bladders or inflatable cushion (40) position at the upper arm in spaced relation when inflated will (1) extends inwardly toward the patient’s torso”]; in this instance, inflating the bladders or air cushions (40) extends away from the interior surface of the rigid outer/inner member and extends inwardly toward the patient's torso [upper arm where the broken humerus is located] when placed on the patient as treatment for aligning the broken humerus bone of the user to facilitate proper healing.
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, Hossler discloses a method of stabilizing a broken humerus bone, comprising the steps of: positioning an upper arm splint device about an upper arm of a user, the upper arm splint device, comprising: a rigid outer member configured to fit upon an outside of an upper arm and shoulder, a rigid inner member configured to fit upon an inside of the upper arm, a plurality of outer stabilization bladders coupled to the rigid outer member and capable of independent inflation, a plurality of inner stabilization bladders coupled to the rigid inner member and capable of independent inflation, and a plurality of bands or straps connecting the rigid outer member to the rigid inner member; and inflating one or more bladders of the plurality of outer stabilization bladders and/or the plurality of inner stabilization bladders causes the broken humerus bone to properly align to facilitate proper healing.
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) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Hossler 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, Hossler 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, in like manner, such that the rigid outer 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.
With respect to claim 3, Hossler 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, 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 as applied to claim 1 above, and further in view of Eriksson U.S. Publication No. (2016/0081843 A1).
With respect to claim 5, Hossler 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 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.
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.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 5712703076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786