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 Objections
Claims 5, 14, and 17-19 are objected to because of the following informalities which require appropriate correction:
In claim 5 line 3: “material silicone” should be “material and silicone”.
In claim 14 line 3: “material silicone” should be “material and silicone”.
In claim 17 line 3: “is a pattern” should be “in a pattern”.
In claim 18 line 3: “is a repeating pattern” should be “in a repeating pattern”.
In claim 18 line 3: “strips the radiation” should be “strips of the radiation”.
In claim 19 line 2: “strips the radiation” should be “strips of the radiation”.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Vissman et al (WO 2015/171467 A1) in view of Mitchell et al (US 5749840).
With respect to claim 1, Vissman discloses a combined wearable support and radiation therapy device (bioceramic materials, articles, and compositions that provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body to provide treatment – para [0005-0007]; the far infrared energy penetrates the cells and provides biomodulatory or physiological effects, such as anti-inflammatory, analgesic, and other biomodulatory or physiological effects – para [0063]; the bioceramic composition is applied to or incorporated within apparel to thereby provide a combined wearable support that also provides radiation therapy – see para [00112]) for use on a wearer (the bioceramic composition is incorporated into an article such as clothing for use on a wearer – para [0006-0007]), comprising: a liner element (articles and apparel that include the bioceramic composition – para [0099-00116]; in particular performance sleeves, knee wraps and leg sleeves – para [00112-00114]), wherein the liner element is adapted to be positioned with at least a portion of the liner element contacting the wearer (sleeves and knee wraps inherently are positioned on the body with an inner surface in contact with the body); and a radiation generating treatment integral with the liner element (the bioceramic composition is applied to or incorporated within the apparel – para [00112]), wherein the radiation generating treatment (bioceramic composition) is operative to generate radiation from heat from the body of the wearer and cause radiation to be directed towards the body of the wearer (the bioceramic materials provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body and heated or exposed to heat to provide treatment – para [0005-0007;0086]; the far infrared energy radiates towards the body (para [0063] and penetrates the cells and provides biomodulatory or physiological effects, such as anti-inflammatory, analgesic, and other biomodulatory or physiological effects – para [0063]).
Vissman does not, however, disclose that the device comprises a support element adapted to be positioned on and removably secured to a part of the body of a wearer wherein when the support element is positioned on the body of the wearer, the liner element is adapted to be positioned between the support element and the body of the wearer with at least a portion of the liner element contacting the wearer.
Mitchell, however, teaches a device (10) configured to provide a dynamic extension and/or flexion splint, having portions attachable to a human body on each side of a body joint and applying a bias force to the joint (col 3 lines 39-43) which includes a support element (pair of mechanical joint assemblies 14 that include first and second strut members 16 and 18 which extend outwardly from a mechanical joint 20 – figs 1-4) adapted to be positioned on and removably secured to a part of the body of a wearer (secured to a user’s limb – col 4 lines 63 – col 5 line 28; the strut members 16 and 18 are removably received in pockets 22 and 24 on opposite sides of sleeve 12 – col 5 lines 12-15) and a liner element (sleeve 12; figs 1 and 4) wherein when the support element is positioned on the body of the wearer, the liner element is adapted to be positioned between the support element and the body of the wearer (the sleeve is worn underneath the joint assemblies as shown in figures 1 and 4 and thus is positioned between the joint assemblies and the limb during use) with at least a portion of the liner element contacting the wearer (the sleeve is adapted to fit snugly around a limb and thus is interpreted as having at least an inner surface contacting the body when worn on a limb; see col 4 line 67 – col 5 line 6). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Vissman to include a support element adapted to be positioned on and removably secured to a part of the body of a wearer wherein when the support element is positioned on the body of the wearer, the liner element is adapted to be positioned between the support element and the body of the wearer with at least a portion of the liner element contacting the wearer, as taught by Mitchell, in order to provide a dynamic extension and/or flexion splint having portions attachable to a human body on each side of a body joint for applying a bias force to the joint.
With respect to claim 2, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 1) and Vissman also discloses that the radiation generating treatment includes a bio-ceramic material (bioceramic compositions – para [0064-0081]).
With respect to claim 3, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 2) and Vissman also discloses that the bio-ceramic material is defined by Tourmaline powder (tourmaline – para [0067]; the bioceramic can be in powder form – para [00165]; examples 1-2 para [00172-00176]).
With respect to claim 4, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 2) and Vissman also discloses that the radiation generating treatment includes a silicone paint (the bioceramic composition can be incorporated into silicone paint – para [00148]).
With respect to claim 5, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 4) and Vissman also discloses that the radiation generating treatment is formed from a mixture of the bio-ceramic material silicone paint (the bioceramic composition can be incorporated into silicone paint – para [00148]) that is no more than twenty percent bio-ceramic material (the bioceramic composition can be mixed with silicone at a ratio between about 1 part bioceramic to 6 parts silicone (16% bioceramic) to 1 part bioceramic to 35 parts silicone (2.9% bioceramic) which include less than 20% of the bioceramic material – see para [00149]).
With respect to claim 6, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 2) and Vissman also discloses that the radiation generated from heat includes far-infrared radiation (the bioceramic materials provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body and heated or exposed to heat to provide treatment – para [0005-0007;0086]).
With respect to claim 7, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 1) and Vissman also discloses that the liner element includes a treatment surface wherein the radiation generating treatment is disposed on the treatment surface (see claims 32-33 which describe that the article is prepared by applying a bioceramic to an inside or an outside of the article – thus, the article includes a surface with the bioceramic composition provided on it which renders it a “treatment” surface).
With respect to claim 8, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 7) wherein Mitchell teaches that the liner element is adapted to be positioned between the support element and the body of the wearer (see rejection of claim 1) and Vissman also discloses that at least a portion of the treatment surface is contacting the wearer (the article comprising the bioceramic contacts the skin such that heat from the body causes the bioceramic to provide far infrared thermal radiation – para [0010;00133] example 5 describes that fabric that is impregnated or infused with the ceramic is directly placed in contact with a skin of a subject – para [00188]).
With respect to claim 9, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 1) and Vissman also discloses that the radiation generating treatment (bioceramic composition) is integral with the liner element (the bioceramic composition is applied to or incorporated within the apparel – see para [00112]) in a pattern in which segments of the liner element containing the radiation generating treatment are interspersed with segments of the liner element containing none of the radiation generating treatment (example 6; para [00191]).
With respect to claim 10, Vissman discloses a combined wearable support and radiation therapy device (bioceramic materials, articles, and compositions that provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body to provide treatment – para [0005-0007]; the far infrared energy penetrates the cells and provides biomodulatory or physiological effects, such as anti-inflammatory, analgesic, and other biomodulatory or physiological effects – para [0063]; the bioceramic composition is applied to or incorporated within apparel to thereby provide a combined wearable support that also provides radiation therapy – see para [00112]) for use on a wearer (the bioceramic composition is incorporated into an article such as clothing for use on a wearer – para [0006-0007]), comprising: a liner element (articles and apparel that include the bioceramic composition – para [0099-00116]; in particular performance sleeves, knee wraps and leg sleeves – para [00112-00114]), wherein the liner element is adapted to be positioned with at least a portion of the liner element contacting the wearer (sleeves and knee wraps inherently are positioned on the body with an inner surface in contact with the body); and a radiation generating treatment integral with the liner element (the bioceramic composition is applied to or incorporated within the apparel – para [00112]), wherein the radiation generating treatment (bioceramic composition) is operative to generate radiation from heat from the body of the wearer and cause radiation to be directed towards the body of the wearer (the bioceramic materials provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body and heated or exposed to heat to provide treatment – para [0005-0007;0086]; the far infrared energy radiates towards the body (para [0063] and penetrates the cells and provides biomodulatory or physiological effects, such as anti-inflammatory, analgesic, and other biomodulatory or physiological effects – para [0063]); wherein the liner element includes a treatment surface wherein the radiation generating treatment is disposed on the treatment surface (see claims 32-33 which describe that the article is prepared by applying a bioceramic to an inside or an outside of the article – thus, the article includes a surface with the bioceramic composition provided on it which renders it a “treatment” surface) and at least a portion of the treatment surface is contacting the wearer during use (the article comprising the bioceramic contacts the skin such that heat from the body causes the bioceramic to provide far infrared thermal radiation – para [0010;00133] example 5 describes that fabric that is impregnated or infused with the ceramic is directly placed in contact with a skin of a subject – para [00188]).
Vissman does not, however, disclose that the device comprises a support element adapted to be positioned on and removably secured to a part of the body of a wearer wherein when the support element is positioned on the body of the wearer, the liner element is adapted to be positioned between the support element and the body of the wearer with at least a portion of the liner element contacting the wearer.
Mitchell, however, teaches a device (10) configured to provide a dynamic extension and/or flexion splint, having portions attachable to a human body on each side of a body joint and applying a bias force to the joint (col 3 lines 39-43) which includes a support element (pair of mechanical joint assemblies 14 that include first and second strut members 16 and 18 which extend outwardly from a mechanical joint 20 – figs 1-4) adapted to be positioned on and removably secured to a part of the body of a wearer (secured to a user’s limb – col 4 lines 63 – col 5 line 28; the strut members 16 and 18 are removably received in pockets 22 and 24 on opposite sides of sleeve 12 – col 5 lines 12-15) and a liner element (sleeve 12; figs 1 and 4) wherein when the support element is positioned on the body of the wearer, the liner element is adapted to be positioned between the support element and the body of the wearer (the sleeve is worn underneath the joint assemblies as shown in figures 1 and 4 and thus is positioned between the joint assemblies and the limb during use) with at least a portion of the liner element contacting the wearer (the sleeve is adapted to fit snugly around a limb and thus is interpreted as having at least an inner surface contacting the body when worn on a limb; see col 4 line 67 – col 5 line 6). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Vissman to include a support element adapted to be positioned on and removably secured to a part of the body of a wearer wherein when the support element is positioned on the body of the wearer, the liner element is adapted to be positioned between the support element and the body of the wearer with at least a portion of the liner element contacting the wearer, as taught by Mitchell, in order to provide a dynamic extension and/or flexion splint having portions attachable to a human body on each side of a body joint for applying a bias force to the joint.
With respect to claim 11, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 10) and Vissman also discloses that the radiation generating treatment includes a bio-ceramic material (bioceramic compositions – para [0064-0081]).
With respect to claim 12, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 11) and Vissman also discloses that the bio-ceramic material is defined by Tourmaline powder (tourmaline – para [0067]; the bioceramic can be in powder form – para [00165]; examples 1-2 para [00172-00176]).
With respect to claim 13, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 11) and Vissman also discloses that the radiation generating treatment includes a silicone paint (the bioceramic composition can be incorporated into silicone paint – para [00148]).
With respect to claim 14, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 13) and Vissman also discloses that the radiation generating treatment is formed from a mixture of the bio-ceramic material silicone paint (the bioceramic composition can be incorporated into silicone paint – para [00148]) that is no more than twenty percent bio-ceramic material (the bioceramic composition can be mixed with silicone at a ratio between about 1 part bioceramic to 6 parts silicone (16% bioceramic) to 1 part bioceramic to 35 parts silicone (2.9% bioceramic) which include less than 20% of the bioceramic material – see para [00149]).
With respect to claim 15, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 11) and Vissman also discloses that the radiation generated from heat includes far-infrared radiation (the bioceramic materials provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body and heated or exposed to heat to provide treatment – para [0005-0007;0086]).
With respect to claim 16, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 10) wherein Mitchell teaches that the liner element is adapted to be positioned between the support element and the body of the wearer (see rejection of claim 1) and Vissman also discloses that at least a portion of the treatment surface is contacting the wearer (the article comprising the bioceramic contacts the skin such that heat from the body causes the bioceramic to provide far infrared thermal radiation – para [0010;00133] example 5 describes that fabric that is impregnated or infused with the ceramic is directly placed in contact with a skin of a subject – para [00188]).
With respect to claim 17, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 10) and Vissman also discloses that the radiation generating treatment (bioceramic composition) is integral with the liner element (the bioceramic composition is applied to or incorporated within the apparel – see para [00112]) in a pattern in which segments of the liner element containing the radiation generating treatment are interspersed with segments of the liner element containing none of the radiation generating treatment (example 6; para [00191]).
With respect to claim 18, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 10) and Vissman also discloses that
the radiation generating treatment (bioceramic composition) is disposed on the treatment surface of the liner element in a repeating pattern in which the radiation generating treatment is interspersed with segments of the treatment surface containing none of the radiation generating treatment (example 6; para [00191]) and wherein the pattern is in the form of elongated strips (the article comprising the bioceramic composition applied in a pattern is shown in figure 1 wherein the pattern is shown repeated in elongated strips (i.e. the pattern appears to be rows of figure 8 symbols aligned endo to end, each row is interpreted as being an elongated strip)).
With respect to claim 20, Vissman discloses a combined wearable support and radiation therapy device (bioceramic materials, articles, and compositions that provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body to provide treatment – para [0005-0007]; the far infrared energy penetrates the cells and provides biomodulatory or physiological effects, such as anti-inflammatory, analgesic, and other biomodulatory or physiological effects – para [0063]; the bioceramic composition is applied to or incorporated within apparel to thereby provide a combined wearable support that also provides radiation therapy – see para [00112]) for use on a wearer (the bioceramic composition is incorporated into an article such as clothing for use on a wearer – para [0006-0007]), comprising: a sleeve element (articles and apparel that include the bioceramic composition – para [0099-00116]; in particular performance sleeves, knee wraps and leg sleeves – para [00112-00114]), wherein the sleeve element is adapted to be positioned around the knee of the wearer (knee wraps inherently are positioned around the knee when worn) with at least a portion of the inner surface contacting the wearer (sleeves and knee wraps inherently are positioned on the body with an inner surface in contact with the body); and a radiation generating treatment integral with the sleeve element (the bioceramic composition is applied to or incorporated within the apparel – para [00112]), wherein the radiation generating treatment (bioceramic composition) is operative to generate radiation from heat from the body of the wearer and, when positioned around the knee of the wearer, causes radiation to be directed towards the body of the wearer (a knee wrap is positioned around the knee when worn; the bioceramic materials provide an exchange of thermal radiation, more specifically far infrared radiation, when in contact with a human body and heated or exposed to heat to provide treatment – para [0005-0007;0086]; the far infrared energy radiates towards the body (para [0063] and penetrates the cells and provides biomodulatory or physiological effects, such as anti-inflammatory, analgesic, and other biomodulatory or physiological effects – para [0063]).
Vissman does not, however, disclose that the device comprises a knee brace element adapted to be positioned on and removably secured around a knee of a wearer wherein the sleeve element is adapted to be positioned between the knee brace element and the knee of the wearer with at least a portion of the inner surface contacting the wearer and at least a portion of the outer surface contacting the knee brace element.
Mitchell, however, teaches a device (10) configured to provide a dynamic extension and/or flexion splint, having portions attachable to a human body on each side of a body joint and applying a bias force to the joint (col 3 lines 39-43; body joint is interpreted as including a knee joint) which includes a knee brace element (pair of mechanical joint assemblies 14 that include first and second strut members 16 and 18 which extend outwardly from a mechanical joint 20 – figs 1-4; the structure is adapted to be positioned on each side of a body joint which is interpreted as including knee joints – thus, the brace structure is interpreted as being a “knee brace”) adapted to be positioned on and removably secured to a knee of a wearer (secured to a user’s limb – col 4 lines 63 – col 5 line 28; the structure is adapted to be positioned on each side of a body joint which is interpreted as including knee joints; the strut members 16 and 18 are removably received in pockets 22 and 24 on opposite sides of sleeve 12 – col 5 lines 12-15) and a sleeve element (sleeve 12; figs 1 and 4) wherein the sleeve element is adapted to be positioned between the knee brace element and the knee of the wearer (the sleeve is worn underneath the joint assemblies as shown in figures 1 and 4 and thus is positioned between the joint assemblies and the joint on the limb during use) with at least a portion of the inner surface contacting the wearer (the sleeve is adapted to fit snugly around a limb and thus is interpreted as having at least an inner surface contacting the body when worn on a limb; see col 4 line 67 – col 5 line 6) and at least a portion of the outer surface contacting the knee brace element (as shown in figures 1 and 4, the joint assemblies are positioned on the outer surface of the sleeve 12). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have modified the device of Vissman to include a knee brace element adapted to be positioned on and removably secured around a knee of a wearer wherein the sleeve element is adapted to be positioned between the knee brace element and the knee of the wearer with at least a portion of the inner surface contacting the wearer and at least a portion of the outer surface contacting the knee brace element, as taught by Mitchell, in order to provide a dynamic extension and/or flexion splint having portions attachable to a human body on each side of a body joint for applying a bias force to the joint.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Vissman et al (WO 2015/171467 A1) in view of Mitchell et al (US 5749840) and further in view of Wust (US 2012/0232448).
With respect to claim 19, Vissman in view of Mitchell discloses the device substantially as claimed (see rejection of claim 18) but does not disclose that the elongated strips of the radiation generating treatment are defined by waves.
Wust, however, teaches application of a heat-activated substance in a wave pattern on a skin-contacting surface of an article to provide spaces between waves that allow skin to breathe (para [0005-0006;0040]; fig 1a). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have formed the elongated strips of the radiation generating treatment on the device of Vissman in view of Mitchell in a wave pattern as taught by Wust in order to permit the skin to breathe between treatment strips.
Conclusion
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786