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 .
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 20 is objected to because of the following informalities: in line 4: “the body” should be “the unitary body”; in line 8: “the secure the first and second portions” should be “configured to secure the first and second portions”. Appropriate correction is required.
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 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunnsteinsson et al (US 2019/0240057).
With respect to claim 1, Gunnsteinsson discloses an orthopedic walker (Fig 17A), comprising: a body formed from at least one polymeric material and having a unitary construction (body 501 formed from at least one polymeric material – para [0190], unitary construction – para [0050]; Fig 17A, see also para [0205],); the body forming first and second portions divided by a median plane and connected to one another by a footbed (Fig 17A, body 501 with first and second portions 502 and 504 and footbed 522), the first and second portions extending from the footbed and forming an interior volume for receiving a foot and lower leg of a user (shown in Fig 17A); wherein the footbed (522) includes an outsole formed unitarily with the body (unitary construction - para [0011]; para [0205] – the outer surface 534 of the footbed 534 may have a curvilinear profile 535 with a tread which is interpreted as being an outsole); wherein the body forms an anterior opening extending along the body between the first and second portions (Fig 17C, opening 536 between portions 502 and 504), and the body forms a posterior opening extending along the body between the first and second portions (fig 17C-D, opening 538 between portions 502 and 504); and wherein the first and second portions are resiliently articulable relative to the median plane to permit expansion and contraction of the interior volume (Fig 17G, articulation shown).
With respect to claim 2, Gunnsteinsson discloses the orthopedic walker as claimed (see rejection of claim 1) and also discloses that the anterior opening (opening 536) extends from a toe region to a proximal edge of the body (as shown in Fig 17C).
With respect to claim 3, Gunnsteinsson discloses the orthopedic walker as claimed (see rejection of claim 1) and also discloses that the posterior opening (opening 538) extends from a proximal edge of the body toward the footbed (as shown in fig 17D).
With respect to claim 4, Gunnsteinsson discloses the orthopedic walker as claimed (see rejection of claim 1) and also discloses that the anterior opening (536) and the posterior opening (538) remain at least partially open when the orthopedic walker is worn by the user (as shown in figs 18A-B).
With respect to claim 5, Gunnsteinsson discloses the orthopedic walker as claimed (see rejection of claim 1) and also discloses that the first and second portions (502,504) are arranged to deflect away from one another during donning of the orthopedic walker (as shown in figs 17G-H) and to return toward one another (as shown in figs 18A-B).
With respect to claims 8-9, Gunnsteinsson discloses the orthopedic walker as claimed (see rejection of claim 1) and also discloses that the body and the outsole are formed from an expanded polymeric material which comprises ethylene-vinyl acetate ([0197], [0119], ethylene-vinyl acetate).
With respect to claim 10, Gunnsteinsson discloses the orthopedic walker as claimed (see rejection of claim 1) and also discloses that the orthopedic walker is configured for use on either a right leg or a left leg of a user (para [0051-0052]).
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.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Gunnsteinsson et al (US 2019/0240057) in view of Howard (US 2005/0145256).
With respect to claims 6-7, Gunnsteinsson et al discloses the orthopedic walker as claimed (see rejection of claim 1) and also discloses that the first and second portions 502, 504 may pivot inwardly toward one another upon application of a load, such as using a strap to tension at least in a circumferential or partially circumferential orientation about the walker 500 (para [0192]). Gunnsteinsson does not, however, explicitly disclose at least one strap arranged to extend across at least one of the anterior opening or the posterior opening wherein the at least one strap cooperates with the body to form a circumferential securing system.
Howard, however, teaches an analogous walker comprising at least one strap extending over at least part of an exterior surface of the body and across at least one of the anterior and posterior openings (Fig 1-2, straps 54 over a part of exterior of portion 14 and crossing over the opening between flaps 22a and 22b on the anterior part of the walker) wherein the at least one strap cooperates with the body to form a circumferential securing system (the straps 54 cooperate with the exterior portion 14 of the walker via passage through apertures 52 as shown in figs 1-2 such that the straps 54 extend completely around the boot and thus circumscribe the structure as shown in figs 1-2). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson with the addition of the straps as taught by Howard in order to properly tension and retain the boot to the user (Howard [0010], [0011]).
Claims 11-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gunnsteinsson et al (US 2019/0240057) in view of Bird et al (US 2013/0066247).
With respect to claim 11, Gunnsteinsson discloses an orthopedic walker (Fig 17A), comprising: a unitary polymeric body (body 501 formed from at least one polymeric material – para [0190], unitary construction – para [0050]; Fig 17A, see also para [0205]); defining a foot-receiving portion (lower receiving section 505 is configured to accommodate the malleolus of an ankle and thus is interpreted as being a foot receiving portion; see para [0186]; fig 18A-B) and a lower-leg-receiving portion (upper receiving section 503 that is configured to accommodate the lower leg as shown in figs 18A-B), the unitary polymeric body having a semi-rigid construction (para [0131]); the unitary polymeric body defining an interior volume (shown in Fig 17A); accessible through at least one longitudinal opening formed in the body (as shown in figs 17G-H the leg is inserted via separation of openings 536 and 538), the longitudinal opening (536,538) arranged for resilient expansion of the body during donning and contraction of the body (as shown in Figs 17G-H); an outsole formed unitarily with and integrally from the unitary polymeric body (unitary construction - para [0011]; para [0205] – the outer surface 534 of the footbed 534 may have a curvilinear profile 535 with a tread which is interpreted as being an outsole).
Gunnsteinsson does not, however, disclose an inflatable liner positioned within the interior volume, the inflatable liner comprising at least one bladder configured to selectively expand within the interior volume wherein inflation of the bladder urges the unitary polymeric body toward a closed configuration about the foot-receiving portion and the lower-leg-receiving portion.
Bird et al teaches an analogous ankle boot further comprising an inflatable liner positioned within the interior volume (bladder positioned within ankle shell cavity - para [0005]), the inflatable liner comprising at least one bladder configured to selectively expand within the interior volume (bladder configured and arranged to be selectively inflated – para [0005]) wherein inflation of the bladder urges the unitary polymeric body toward a closed configuration about the foot-receiving portion and the lower-leg-receiving portion (inflating of the bladders selectively places pressure on a lower leg portion of a patient to provide a selected amount of support – para [0045]; the pressure is interpreted as urging the structure towards a closed configuration around the leg in order to provide the requisite stability and support). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson to further include an inflatable liner as taught by Bird et al in order to better secure the system to the user and provide improved support to the leg/foot (Bird et al [0005;0036;0045]).
With respect to claim 12, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Bird further teaches a pump (Fig 1, pump 120b) supported by the unitary polymeric body (as shown in fig 1) and fluidly coupled to the inflatable liner (inflation pumps 120a and 120b are coupled to the respective pump connection portions 406a and 406b of the bladder inflation assemblies 402a and 402b through the respective air pump passages 220a and 220b in the walker shell 102 – para [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gunnsteinsson in view of Bird to include a pump as taught by Bird et al in order to provide inflation means for the bladder on the device of Gunnsteinsson in view of Bird to thereby better secure the system to the user and provide improved support to the leg/foot (Bird et al [0005;0036;0045]).
With respect to claim 13, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Bird further teaches a valve (Fig 1, valve 122b) in fluid communication with the inflatable liner (relief valve apertures 222a and 222b provide passages for a relief valve 122b to the respective bladder – para [0037]) and accessible from an exterior surface of the unitary polymeric body (as shown in fig 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson in view of Bird to include a valve as taught by Bird in order to permit a user to control/adjust inflation by selectively releasing air out of the bladder using the valve to deflate the bladder (Bird para [0036]).
With respect to claim 14, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Bird further teaches that the inflatable liner includes at least one bladder (402a/402b; fig 9A) arranged to contact both the foot-receiving portion and the lower-leg-receiving portion (as shown in fig 11, at least bladder 402b extends from the foot receiving portion into at least a lower part of the lower leg receiving portion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson in view of Bird to include at least one bladder arranged to contact both the foot-receiving portion and the lower-leg-receiving portion as taught by Bird in order to provide support and stability to both the foot and lower leg of the user.
With respect to claim 15, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Bird further teaches that the inflatable liner (bladders 402a/402b; fig 9A) is removable from the interior volume (as shown in fig 9A). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson in view of Bird so that the inflatable liner is removable like the bladders in Bird in order to permit removal for replacement or cleaning.
With respect to claim 16, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Bird further teaches that the inflatable liner (bladders 402a/402b; fig 9A) is configured to fill voids between the interior volume of the unitary polymeric body and anatomical features of a user (air inflation pump 120b is designed to selectively inflate a bladder that is positioned around the patient's ankle to selectively provide stability – para [0036]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson in view of Bird so that the inflatable liner is configured to fill voids between the interior volume of the unitary polymeric body and anatomical features of a user like the bladders in Bird in order to provide stability to the user’s ankle.
With respect to claim 17, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Gunnsteinsson further discloses that the unitary polymeric body provides structural support to the foot and lower leg without a separate rigid frame (the semi-rigid nature of the body material provides rigid support to the limb – para [0010]).
With respect to claim 18, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Gunnsteinsson further discloses the at least one longitudinal opening extends from a toe region of the body to a proximal edge of the body (opening 536 extends from a toe region to a proximal edge of the body as shown in Fig 17C).
With respect to claim 19, Gunnsteinsson in view of Bird discloses the orthopedic walker substantially as claimed (see rejection of claim 11) and Gunnsteinsson further discloses that the outsole is configured to contact a ground surface without attachment of a separate outsole component (the outer surface 534 of the footbed 534 may have a curvilinear profile 535 with a tread to enable foot rollover and traction for walking – para [0205]; thus, the outer surface with treads is configured to contact the ground during walking and does not require a separate outsole)
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Gunnsteinsson et al (US 2019/0240057) in view of Howard (US 2005/0145256) and further in view of Bird et al (US 2013/0066247).
With respect to claim 20, Gunnsteinsson discloses an orthopedic walker (Fig 17A), comprising: a unitary body formed from an expanded polymeric material (body 501 formed from at least one polymeric material – para [0190], unitary construction – para [0050]; Fig 17A, see also para [0205]; the polymeric material is ethylene-vinyl acetate which is an expanded polymeric material – see para [0197], [0119]); the unitary body defining first and second portions (Fig 17A, body 501 with first and second portions 502 and 504) separated by both an anterior longitudinal opening (Fig 17C, opening 536 between portions 502 and 504) and a posterior longitudinal opening (fig 17C-D, opening 538 between portions 502 and 504) extending between a toe region and a proximal region of the body (as shown in Fig 17C), the unitary body including a footbed (footbed 522) and an outsole formed integrally with the unitary body (unitary construction - para [0011]; para [0205] – the outer surface 534 of the footbed 534 may have a curvilinear profile 535 with a tread which is interpreted as being an outsole), wherein the unitary body is resiliently deformable to open during donning and to return toward a closed configuration (para [0010]; open for donning as shown in Figs 17G-H; return to closed configuration shown in figs 18A-B)
Gunnsteinsson also discloses that the first and second portions 502, 504 may pivot inwardly toward one another upon application of a load, such as using a strap to tension at least in a circumferential or partially circumferential orientation about the walker 500 (para [0192]). Gunnsteinsson does not, however, disclose a plurality of straps extending across the anterior longitudinal opening and the posterior longitudinal opening to secure the first and second portions about a foot and lower leg of a user.
Howard, however, teaches an analogous walker comprising an exterior shell 14 that includes anterior and posterior longitudinal openings (as shown in fig 3) and straps extending over at least part of an exterior surface of the body and across the anterior and posterior openings (Fig 1-2, straps 54 over a part of exterior of portion 14 and crossing over the anterior/posterior openings in shell 14 since the straps 54 extend circumferentially around the walker as shown in figs 1-2) and wherein the straps secure the first and second portions about a foot and lower leg of a user (the straps are tensioned to secure the internal boot within the external shell – para [0010]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson with the addition of the straps as taught by Howard in order to properly tension and retain the boot to the user (Howard [0010], [0011]).
Gunnsteinsson also does not disclose an inflatable liner positioned within the unitary body and including at least one bladder inflatable by a pump mounted to the unitary body.
Bird et al teaches an analogous ankle boot further comprising an inflatable liner positioned within the interior volume (bladder positioned within ankle shell cavity - para [0005]), the inflatable liner comprising at least one bladder configured to selectively expand within the interior volume (bladder configured and arranged to be selectively inflated – para [0005]) inflatable by a pump (Fig 1, pump 120b; inflating of the bladders selectively places pressure on a lower leg portion of a patient to provide a selected amount of support – para [0045]) mounted to the unitary body (as shown in fig 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Gunnsteinsson in view of Howard to further include an inflatable liner as taught by Bird et al in order to better secure the system to the user and provide improved support to the leg/foot (Bird et al [0005;0036;0045]).
Double Patenting
NON-STATUTORY DOUBLE PATENTING
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-3, 6-13, 18 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 5-6 of U.S. Patent No. 12533251 (hereinafter “the ‘251 patent”).
Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 of the present application and claim 1 of the ‘251 patent differ in that the patented claims include more elements than the claims in the present application and, therefore, are more narrow and specific. Thus, claim 1 of the ‘251 Patent is in effect a “species” of the broader, “generic” invention recited in claim 1 of the present application. It has been held that a generic invention is anticipated by the species. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Thus, claim 1 of the present application is anticipated by claim 1 of the ‘251 patent and, therefore, is not patentably distinct from claim 1 of the ‘251 patent.
All of the limitations of claim 2 can be found in claim 1 of the ‘251 Patent. All of the limitations of claim 3 can be found in claim 1 of the ‘251 Patent. All of the limitations of claim 6 can be found in claim 3 of the ‘251 Patent. All of the limitations of claim 7 can be found in claim 5 of the ‘251 Patent. All of the limitations of claim 8 can be found in claim 1 of the ‘251 Patent. All of the limitations of claim 9 can be found in claim 1 of the ‘251 Patent. All of the limitations of claim 10 can be found in claim 2 of the ‘251 Patent. All of the limitations of claim 11 can be found in claims 1 and 6 of the ‘251 Patent. All of the limitations of claim 12 can be found in claim 6 of the ‘251 Patent. All of the limitations of claim 13 can be found in claim 6 of the ‘251 Patent. All of the limitations of claim 18 can be found in claim 1 of the ‘251 Patent. All of the limitations of claim 20 can be found in claims 1, 3 and 6 of the ‘251 Patent.
Claims 4-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12533251 (hereinafter “the ‘251 patent”) in view of Gunnsteinsson et al (US 2019/0240057).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘251 patent in view of Gunnsteinsson to one having ordinary skill in the art at the time of the invention. Specifically, claims 4-5 of the present application differ from claim 1 of the ‘251 Patent in that the patent claims do not disclose that the anterior opening and the posterior opening remain at least partially open when the orthopedic walker is worn by the user or that the first and second portions are arranged to deflect away from one another during donning of the orthopedic walker and to return toward one another.
Gunnsteinsson, however, teaches an orthopedic walker (Fig 17A), comprising: a body formed from at least one polymeric material and having a unitary construction (body 501 formed from at least one polymeric material – para [0190], unitary construction – para [0050]; Fig 17A, see also para [0205],); the body forming first and second portions divided by a median plane and connected to one another by a footbed (Fig 17A, body 501 with first and second portions 502 and 504 and footbed 522), the first and second portions extending from the footbed and forming an interior volume for receiving a foot and lower leg of a user (shown in Fig 17A); wherein the footbed (522) includes an outsole formed unitarily with the body (unitary construction - para [0011]; para [0205] – the outer surface 534 of the footbed 534 may have a curvilinear profile 535 with a tread which is interpreted as being an outsole); wherein the body forms an anterior opening extending along the body between the first and second portions (Fig 17C, opening 536 between portions 502 and 504), and the body forms a posterior opening extending along the body between the first and second portions (fig 17C-D, opening 538 between portions 502 and 504); and wherein the first and second portions are resiliently articulable relative to the median plane to permit expansion and contraction of the interior volume (Fig 17G, articulation shown). Gunnsteinsson further discloses that the anterior opening (536) and the posterior opening (538) remain at least partially open when the orthopedic walker is worn by the user (as shown in figs 18A-B) and that the first and second portions (502,504) are arranged to deflect away from one another during donning of the orthopedic walker (as shown in figs 17G-H) and to return toward one another (as shown in figs 18A-B). 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 walker of the ‘251 patent so that the anterior opening and the posterior opening remain at least partially open when the orthopedic walker is worn by the user or that the first and second portions are arranged to deflect away from one another during donning of the orthopedic walker and to return toward one another, as taught by Gunnsteinsson, in order to render the walker easier to apply and remove from the user’s leg.
Claims 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12533251 (hereinafter “the ‘251 patent”) in view of Bird et al (US 2013/0066247).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘251 patent in view of Gunnsteinsson and Bird to one having ordinary skill in the art at the time of the invention. Specifically, claims 14-16 of the present application differ from claims 1 and 6 of the ‘251 Patent in that the patent claims do not disclose that the inflatable liner includes at least one bladder arranged to contact both the foot-receiving portion and the lower-leg-receiving portion, wherein the inflatable liner is removable from the interior volume, wherein the inflatable liner is configured to fill voids between the interior volume of the unitary polymeric body and anatomical features of a user,
Bird et al teaches an ankle boot comprising an inflatable liner positioned within the interior volume (bladder positioned within ankle shell cavity - para [0005]), the inflatable liner comprising at least one bladder configured to selectively expand within the interior volume (bladder configured and arranged to be selectively inflated – para [0005]) wherein inflation of the bladder urges the unitary polymeric body toward a closed configuration about the foot-receiving portion and the lower-leg-receiving portion (inflating of the bladders selectively places pressure on a lower leg portion of a patient to provide a selected amount of support – para [0045]; the pressure is interpreted as urging the structure towards a closed configuration around the leg in order to provide the requisite stability and support).
Bird further teaches that the inflatable liner includes at least one bladder (402a/402b; fig 9A) arranged to contact both the foot-receiving portion and the lower-leg-receiving portion (as shown in fig 11, at least bladder 402b extends from the foot receiving portion into at least a lower part of the lower leg receiving portion). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of ‘251 patent to include at least one bladder arranged to contact both the foot-receiving portion and the lower-leg-receiving portion as taught by Bird in order to provide support and stability to both the foot and lower leg of the user.
Bird further teaches that the inflatable liner (bladders 402a/402b; fig 9A) is removable from the interior volume (as shown in fig 9A). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of the ‘251 patent so that the inflatable liner is removable like the bladders in Bird in order to permit removal for replacement or cleaning.
Bird further teaches that the inflatable liner (bladders 402a/402b; fig 9A) is configured to fill voids between the interior volume of the unitary polymeric body and anatomical features of a user (air inflation pump 120b is designed to selectively inflate a bladder that is positioned around the patient's ankle to selectively provide stability – para [0036]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of the ‘251 patent so that the inflatable liner is configured to fill voids between the interior volume of the unitary polymeric body and anatomical features of a user like the bladders in Bird in order to provide stability to the user’s ankle.
Claims 17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of U.S. Patent No. 12533251 (hereinafter “the ‘251 patent”) in view of Gunnsteinsson et al (US 2019/0240057).
Although the claims at issue are not identical, they are not patentably distinct from each other because the application claims would have been obvious over the ‘251 patent in view of Gunnsteinsson and Bird to one having ordinary skill in the art at the time of the invention. Specifically, claims 17 and 19 of the present application differ from claims 1 and 6 of the ‘251 Patent in that the patent claims do not disclose that the unitary polymeric body provides structural support to the foot and lower leg without a separate rigid frame and wherein the outsole is configured to contact a ground surface without attachment of a separate outsole component.
Gunnsteinsson, however, teaches an orthopedic walker (Fig 17A), comprising: a unitary polymeric body (body 501 formed from at least one polymeric material – para [0190], unitary construction – para [0050]; Fig 17A, see also para [0205]); defining a foot-receiving portion (lower receiving section 505 is configured to accommodate the malleolus of an ankle and thus is interpreted as being a foot receiving portion; see para [0186]; fig 18A-B) and a lower-leg-receiving portion (upper receiving section 503 that is configured to accommodate the lower leg as shown in figs 18A-B), the unitary polymeric body having a semi-rigid construction (para [0131]); the unitary polymeric body defining an interior volume (shown in Fig 17A); accessible through at least one longitudinal opening formed in the body (as shown in figs 17G-H the leg is inserted via separation of openings 536 and 538), the longitudinal opening (536,538) arranged for resilient expansion of the body during donning and contraction of the body (as shown in Figs 17G-H); an outsole formed unitarily with and integrally from the unitary polymeric body (unitary construction - para [0011]; para [0205] – the outer surface 534 of the footbed 534 may have a curvilinear profile 535 with a tread which is interpreted as being an outsole).
Gunnsteinsson further discloses that the unitary polymeric body provides structural support to the foot and lower leg without a separate rigid frame (the semi-rigid nature of the body material provides rigid support to the limb – para [0010]) and that the outsole is configured to contact a ground surface without attachment of a separate outsole component (the outer surface 534 of the footbed 534 may have a curvilinear profile 535 with a tread to enable foot rollover and traction for walking – para [0205]; thus, the outer surface with treads is configured to contact the ground during walking and does not require a separate outsole)
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 walker of the ‘251 patent so that the unitary polymeric body provides structural support to the foot and lower leg without a separate rigid frame and wherein the outsole is configured to contact a ground surface without attachment of a separate outsole component, as taught by Gunnsteinsson, in order to simplify the device by eliminating the need for additional elements to provide structural support and to permit walking, thereby reducing manufacturing costs and making the device easier to use for a wearer.
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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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786
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