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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 7 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Specifically, Claim 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. Claim 7 positively recites part of the human body in combination with the device, as for example: in claim 7, the limitation reciting “…an L-shape cross-sectional profile that elevates a heel of the foot” of the claim encompasses a human being. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the constitution. Accordingly, proper procedure where a claim is directed to an apparatus “attached to” the human body or any part thereof is to reject such claim under 35 U.S.C 101 with an explanation that, because the claim positively recites a part of the human body, it is directed to nonstatutory subject matter. See Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987). Therefore, for at least this reason, claim 7 has been rejected under 35 USC 101. It is suggested that the claim be amended to recite “…an L-shape cross-sectional profile that is configured to elevate a heel of the foot” in order to overcome this deficiency.
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) 1-5 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al (US 2015/0018740 A1).
As per Claim 1, Davis discloses a medical boot for a bedridden patient (ABSTRACT; medical boot 100), the medical boot (100) comprising: an exterior layer (Fig 5: 162, 160, 158 combine to form the exterior layer; [0062]) including a first fabric layer (Fig 5: exterior fabric layer 162; [0062], [0066]), a foam layer (Fig 5: 160 is typically a relatively dense elastic material that flexes or compresses slightly to provide a resilient interface with the lower leg, for example, foam; [0065]), and a second fabric layer (Fig 5: material 156 includes the entire lining 158 of the therapeutic boot 100 and is positioned to surround the lower leg of the patient; [0063]) laminated together (the fleece material 156 is laminated to the lining 158; [0063]); having: a posterior support portion shaped for wrapping around a lower leg (Fig 6: the lower leg support cradle 164 includes a posterior flat surface 170 and side walls 172 that extend along the longitudinal sides of the lower leg. The lower leg support cradle 164 provides a longitudinal channel 168 that receives the lower leg of a patient. The posterior flat surface 170 stabilizes the lower leg support cradle 164 and lower leg against rotation when the patient rests in a supine position and the heel float therapeutic boot 100 is supported on a bed; [0069]); and a planar support portion extending from the posterior support portion, the planar support portion shaped for wrapping around a foot (Fig 6: foot support platform 166. The lower leg support 164 and the foot support platform 166 are connected together to form one continuous piece; [0068]; Fig 15: wings 218, 220 configured to wrap around a foot; [0092]); one or more foam blocks positioned on the exterior layer (support 400 may be covered on the exterior surface with a fabric or foam to prevent injury to other limbs while lying down in bed; the squared block shape of the heel support structure 404 helps to keep the foot of the patient upright and not roll over; [0144]; Fig 40); and an interior layer attached to the exterior layer (Fig 5: fleece interior layer 156; [0062]-[0063]; the fleece material 156 can be placed on the lining 158 by other attachment means, such as, adhesive, sewing, or combinations of these or other attachment means; [0063]).
Davis discloses that the exterior layer is manufactured such that it is formed into a shape (as shown i.e. in figs 1-4 the exterior layer of boot 100 is formed having a specific shape that is configured for application to a user’s leg/foot) but is silent as to the method of forming the exterior layer into this shape and, thus, does not explicitly disclose the exterior layer being die cut. The claimed phrase “an exterior layer…die cut into a shape” is being treated as a product by process limitation; that is, that the exterior layer is made by die cutting the layer. As set forth in MPEP 2113, product by process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though Davis is silent as to the specific process used to form the exterior layer of the boot into the final shape shown in figures 1-4, it appears that the product in Davis would be the same or similar as that claimed, especially since the prior art and claimed products include the same fabric and foam layers in the exterior layer and, furthermore, are configured to be shaped as a medical boot.
As per Claim 2, Davis discloses the medical boot as claimed (see rejection of claim 1) and also discloses that the first and second fabric layers are made of a loop material (the fastening mechanism 144a includes a hook patch 146 and a loop patch 148, loop patch 148 is attached to the exterior surface fabric layer of the upper overlapping member 130 and the hook patch 146 is attached to the right side panel 142a of the upper overlapping member 130, the hook and loop patches 146, 148 are sewn onto respective fabric layer panels of the upper overlapping member 130 to be fastened together as the two overlap; [0058]).
As per Claim 3, Davis discloses the medical boot as claimed (see rejection of claim 2) and also discloses that the exterior layer further includes fasteners that removably attach to the loop material (the fastening mechanism 144a includes a hook patch 146 and a loop patch 148 such as Velcro; [0058]).
As per Claim 4, Davis discloses the medical boot as claimed (see rejection of claim 1) and also discloses that the exterior layer includes compression lines that facilitate wrapping the posterior support portion around the lower leg, and that facilitate wrapping the planar support portion around the foot (forming by laminating; [0078]; with flexible hinge 200 formed at the location where the lower leg support portion 102 and the foot support portion 104 are connected together for wrapping around the lower leg and foot; [0079]; the foot support portion 104 is connected to the lower leg support portion 102 creating a hinge between the two; [0054]).
As per Claim 5, Davis discloses the medical boot as claimed (see rejection of claim 1) and also discloses that the exterior layer includes an interior area between a first side, a second side, a proximal end, and a distal end, and the interior area is seamless (Figs 6-7: lower leg support cradle 164 includes a posterior flat surface 170 and first and side walls 172 that extend along the longitudinal sides of the lower leg. The lower leg support cradle 164 provides a longitudinal channel 168 which serves as an interior area for receiving the lower leg of a patient; [0069]; lower leg support cradle 164 and a foot support platform 166 connected together to form one continuous, seamless piece; [0068]).
As per Claim 9, Davis discloses the medical boot as claimed (see rejection of claim 1) and also discloses that the interior layer is made of a fleece material (Fig 5: fleece interior layer 156; [0062]-[0063]).
As per Claim 10, Davis discloses the medical boot as claimed (see rejection of claim 1) and also discloses that the planar support portion continuously extends from the posterior support portion as a single assembly (Fig 6 illustrates the lower leg support cradle 164 and a foot support platform 166 connected together to form one continuous piece; [0068]).
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) 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al (US 2015/0018740 A1).
As per Claim 6, Davis discloses the medical boot as claimed (see rejection of claim 1) and also discloses that the one or more foam blocks include: a first foam block positioned in the posterior support portion, the first foam block having a first density; and a second foam block positioned on the first foam block, the second foam block having a second density (Fig 42: The squared block shape of the heel support structure 404 helps to keep the foot of the patient upright and not roll over. It is to be understood that the size, geometry and configuration of the foam support panels may vary with other examples; [0144]; foam materials inherently have a density; the heel support structure 404 further includes a first foam posterior leg support panel 430 extending from the main body 422 of the heel support structure 404; [0134]; additional second foam blocks attached to panel 430 include posterior wall 424 and the side walls 426a, 426b of the example heel support structure 404, having generally a squared shape; [0136]; the heel support structure 404 is a removable, repositionable structure, and the heel support structure 404 is a multiple piece structure (e.g., two piece) such that at least one of the pieces or all pieces can be removable and repositionable; [0152]; The heel float cradle with squared blocks shaping the heel support structure 404 can for example be constructed of a variety of materials including elastomers, polyurethane foam, and/or other open and/or closed cell foams or combinations thereof. The durometer and resilience of the material preferably compresses slightly and springs back to shape upon relieving any pressure. The heel support structure 404 is illustrated and described in more detail with reference to FIGS. 36-42; [0123]).
Davis does not, however, explicitly disclose that the second density is lower than the first density. It would have been obvious, however, to one having ordinary skill in the art, before the effective filing date of the invention, to have selected (from the variety of materials taught by Davis) first/second foam materials where the second foam has a density lower than the density of the first foam in order to provide an arrangement which compresses slightly and springs back to shape upon relieving any pressure and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
As per Claim 7, Davis discloses the medical boot substantially as claimed (see rejection of claim 6) and Davis also discloses that the first and second foam blocks form an L-shape cross-sectional profile that elevates a heel of the foot (Fig 42 illustrates an L-shaped cross-sectional profile in a side perspective view of the heel support structure 404, which includes coupled foam block sections including side walls 426a, 426b, coupled with the rounded corners 438, the rounded bottom 440, and a left side 458 of the heel support structure 404; [0146]-[0147]).
As per Claim 8, Davis discloses the medical boot substantially as claimed (see rejection of claim 6) and also discloses that the one or more foam blocks further include: a third foam block positioned in the planar support portion (squared block shape(s) the heel support structure 404; [0144]; further includes a third foam foot support block panel 432 that each extend from the main body 422 of the heel support structure 404; [0134]).
Claim(s) 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al (US 2015/0018740 A1) in view of Heyd et al (US 11,026,827 B2).
As per Claim 11, Davis discloses a method of manufacturing a medical boot (FIG. 17 is a flow chart illustrating an example method 250 of making a heel float therapeutic boot 100; [0097]), the method comprising: forming an exterior layer by laminating (Fig 5: 162, 160, 158 combine to form the exterior layer; [0062]; inner fleece material 156 is laminated to the lining 158 of the therapeutic boot 100, the fleece material 156 can be placed on the lining 158 by other attachment means, such as, adhesive, sewing, or combinations of these or other attachment means; [0063]); the exterior layer comprising a first fabric layer (Fig 5: exterior fabric layer 162; [0062], [0066]), a foam layer (Fig 5: 160 is typically a relatively dense elastic material that flexes or compresses slightly to provide a resilient interface with the lower leg, for example, foam; [0065]), and a second fabric layer (Fig 5: material 156 includes the entire lining 158 of the therapeutic boot 100 and is positioned to surround the lower leg of the patient; [0063]) into a sheet (e.g. Figs 5-7 illustrate a continuous sheet of material; lower leg support cradle 164 and a foot support platform 166. In this example, the lower leg support cradle 164 and the foot support platform 166 are connected together to form one continuous piece; [0068]) and forming the sheet into a shape (the boot inherently is formed into the shape of the finished product as shown i.e. in figs 1-4) having: a posterior support portion shaped for wrapping around a lower leg (Fig 17: method step 252 is performed to form a lower leg support portion 102 and a foot support portion 104. Examples of the lower leg support portion 102 and the foot support portion 104 are shown and described with reference to Figs 1-3; [0098]; also Fig 6: the lower leg support cradle 164 includes a posterior flat surface 170 and side walls 172 that extend along the longitudinal sides of the lower leg. The lower leg support cradle 164 provides a longitudinal channel 168 that receives the lower leg of a patient. The posterior flat surface 170 stabilizes the lower leg support cradle 164 and lower leg against rotation when the patient rests in a supine position and the heel float therapeutic boot 100 is supported on a bed; [0069]); and a planar support portion extending from the posterior support portion, the planar support portion shaped for wrapping around a foot (Fig 17: method step 252 is performed to form a lower leg support portion 102 and a foot support portion 104. Examples of the lower leg support portion 102 and the foot support portion 104 are shown and described with reference to Figs 1-3: the foot support portion 104 includes a foot support platform 166. An example of a foot support platform 166 is shown and described with reference to Fig 11; [0098]; also Fig 6: foot support platform 166. The lower leg support 164 and the foot support platform 166 are connected together to form one continuous piece; [0068]; Fig 15: wings 218, 220 configured to wrap around a foot; [0092]); positioning one or more foam blocks on the exterior layer (squared block shape of the heel support structure 404 helps to keep the foot of the patient upright and not roll over; [0144]; Fig 40; it is inherent that the block is “positioned” on the exterior layer in order to be provided at that location on the finished product); attaching an interior layer to the exterior layer (Fig 5: fleece interior layer material 156 can be placed on the lining 158 by attachment means, such as, adhesive, sewing, or combinations of these or other attachment means; [0063]); and attaching one or more fasteners to the exterior layer (upper overlapping member 130 includes a left side panel 140a extending from the left side wall 134 of the lower leg support portion 102 and a right side panel 142a extending from the right side wall 136 of the lower leg support portion 102. The upper overlapping member 130 has a fastening mechanism 144a to connect the left side panel 140a together with the right side panel 142a, fastening mechanism 144a includes a hook patch 146 and a loop patch 148; other fastening mechanisms are used, such as, buttons, adhesive, hooks, clips, clasps, bolts, straps, or combinations of these or other fastening mechanisms; [0058]; also lower overlapping member 132 includes a left side panel 140b and a right side panel 142b extending from the left and right side walls 134, 136 of the lower leg support portion 102, the lower overlapping member 132 has a fastening mechanism 144b to connect the left and right side panels 140b, 142b together, lower overlapping member 132 may also be provided the fastening mechanism 144b similar to those described for the upper overlapping member 130. Accordingly, fastening mechanisms for the lower overlapping member 132 are similar to the upper overlapping member 130 previously described; [0059]); the one or more fasteners configured to attach to the first and second fabric layers of the exterior layer for removably wrapping the medical boot around the lower leg and the foot (the upper and lower overlapping members 130, 132 of the lower leg support portion 102 are arranged and configured to wrap and fasten about an anterior portion of the lower leg. In other examples, the lower leg support portion 102 may extend further up the leg. In some embodiments, the upper overlapping member 130 and the lower overlapping member 132 are arranged and configured to define an opening 150 in the front of the lower leg support portion 102 of the heel float therapeutic boot 100; [0060]).
Davis does not, however, specifically disclose laminating a first fabric layer, a foam layer, and a second fabric layer into a sheet and die cutting the sheet into a shape. However, Heyd teaches a custom or prefabricated ankle foot orthosis (ABSTRACT) and the method of manufacture (Fig 7 provides a process flow diagram of a method of manufacture of an ankle foot orthosis according to the disclosure; Col 5 In 49-51), wherein the method of manufacture includes laminating a first fabric layer, a foam layer, and a second fabric layer into a sheet (as illustrated, the brace body 12 comprises a laminated structure of at least three material layers including an inner layer 34, a polyolefin elastomeric outer layer 36, and the rigid or semi-rigid key structural components as an intermediate layer 38 between the inner and outer layers 32, 34; inner layer 34 is composed of a closed cell polyethylene (PE) foam; Col 3 In 53-59); and die cutting the sheet into a shape (Fig 7: In a step D, the key structural thermoplastic components are manufactured using predetermined, standardized sizing and can be stamped out of sheet material using a clicker die press process or similar; Col 6 In 28-31; also the size and shape of the key structural thermoplastic components and the template that fits the fabrication standards established corresponds to the size of the key structural thermoplastic component used for fabrication; Col 6 In 28-44). It would have been obvious to one of ordinary skill in the art prior, before the effective filing date of the invention, to modify the method of manufacturing a medical boot disclosed by Davis, by including the manufacturing method steps of laminating and then die cutting the sheet into a shape, as taught by Heyd, to provide the product in a predetermined size so that it is ready for use and a patient may choose a pre-fabricated standard size that most closely fits their foot size by measuring the instep of a patient and patient's shoe size to determine the best pre-fabricated size on a sizing chart (Heyd Col 5 In 48-64).
As per Claim 12, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 11) and Davis also discloses that positioning the one or more foam blocks on the exterior layer includes: positioning a first foam block in the posterior support portion; and positioning a second foam block on the first foam block, the first and second foam blocks forming an L shape cross-sectional profile (Fig 42 illustrates an L-shaped cross-sectional profile in a side perspective view of the heel support structure 404, which includes coupled foam block sections including side walls 426a, 426b, coupled with the rounded corners 438, the rounded bottom 440, and a left side 458 of the heel support structure 404; [0146]-[0147]).
As per Claim 13, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 12) and Davis also discloses that the first foam block has a first density, and the second foam block has a second density (Fig 42: The squared block shape of the heel support structure 404 helps to keep the foot of the patient upright and not roll over. It is to be understood that the size, geometry and configuration of the foam support panels may vary with other examples; squared blocks shaping the heel support structure 404 can for example be constructed of a variety of combinations of materials with differing densities, including elastomers, polyurethane foam, and/or other open and/or closed cell foams or combinations thereof, with durometer and resilience of the material preferably compresses slightly and springs back to shape upon relieving any pressure. The heel support structure 404 is illustrated and described in more detail with reference to FIGS. 36-42; [0123] [0144]; the heel support structure 404 further includes a first foam posterior leg support panel 430 extending from the main body 422 of the heel support structure 404; [0134]; additional second foam blocks attached to panel 430 include posterior wall 424 and the side walls 426a, 426b of the example heel support structure 404, having generally a squared shape; [0136]; the heel support structure 404 is a removable, repositionable structure, and the heel support structure 404 is a multiple piece structure (e.g., two piece) such that at least one of the pieces or all pieces can be removable and repositionable; [0152]).
Davis does not, however, explicitly disclose that the second density is lower than the first density. It would have been obvious, however, to one having ordinary skill in the art, before the effective filing date of the invention, to have selected (from the variety of materials taught by Davis) first/second foam materials where the second foam has a density lower than the density of the first foam in order to provide an arrangement which compresses slightly and springs back to shape upon relieving any pressure and, furthermore, because it is within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
As per Claim 14, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 12) and Davis also discloses that positioning the one or more foam blocks on the exterior layer further includes: positioning a third foam block in the planar support portion (squared block shape(s) the heel support structure 404; [0144]; further includes a third foam foot support block panel 432 that each extend from the main body 422 of the heel support structure 404; [0134]).
As per Claim 15, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 11) and Davis also discloses that laminating the first fabric layer, the foam layer, and the second fabric layer into the sheet produces compression lines that facilitate wrapping the medical boot around the lower leg and the foot (forming by laminating; [0078]; with flexible hinge 200 formed at the location where the lower leg support portion 102 and the foot support portion 104 are connected together for wrapping around the lower leg and foot; [0079]; the foot support portion 104 is connected to the lower leg support portion 102 creating a hinge between the two; [0054]).
As per Claim 16, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 11) and Davis also discloses that the exterior layer includes an interior area between a first side, a second side, a proximal end, and a distal end, and the interior area is seamless (Figs 6-7: lower leg support cradle 164 includes a posterior flat surface 170 and first and side walls 172 that extend along the longitudinal sides of the lower leg. The lower leg support cradle 164 provides a longitudinal channel 168 which serves as an interior area for receiving the lower leg of a patient; [0069]; lower leg support cradle 164 and a foot support platform 166 connected together to form one continuous, seamless piece; [0068]).
As per Claim 17, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 11) and Davis also discloses that the first and second fabric layers are made of a loop material, and the one or more fasteners are hook fasteners (the fastening mechanism 144a includes a hook patch 146 and a loop patch 148, loop patch 148 is attached to the exterior surface fabric layer of the upper overlapping member 130 and the hook patch 146 is attached to the right side panel 142a of the upper overlapping member 130, the hook and loop patches 146, 148 are sewn onto respective fabric layer panels of the upper overlapping member 130 to be fastened together as the two overlap; the fastening mechanism 144a includes a hook patch 146 and a loop patch 148 (such as Velcro; [0058]).
As per Claim 18, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 17) and Davis also discloses that the interior layer is made of a fleece material (Fig 5: fleece interior layer 156; [0062]-[0063]).
As per Claim 19, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 18) and Davis also discloses that the interior layer is sewn onto the exterior layer (the fleece material 156 can be placed on the lining 158 by other attachment means, such as, adhesive, sewing, or combinations of these or other attachment means; [0063]).
As per Claim 20, Davis in view of Heyd discloses the method substantially as claimed (see rejection of claim 19) and Davis also discloses that the planar support portion continuously extends from the posterior support portion (Fig 6 illustrates the lower leg support cradle 164 and a foot support platform 166 connected together to form one continuous piece; [0068]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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