DETAILED ACTION
In Applicant’s Response filed 7/18/25, Applicant has amended claims 1, 3, 5-6, and 20; and cancelled claim 11. Currently, claims 1-10 and 12-20 are pending.
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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means,” and, therefore, are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: a “means for securing” as recited in claim 1. Specifically, these limitations recite a generic placeholder (“means”) coupled with functional language (“securing”) without giving sufficient structure, material or acts for achieving this function. Thus, for claim 1, the phrase “means for securing” will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, and is being interpreted to cover the corresponding structure described in the specification (the means for securing comprises one or more foot straps and/or one or more leg straps – specification para [0025]) as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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, 3-6 and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman (US 8402678) in view of Grimes (US 2016/0338868).
With respect to claim 1, Kopelman discloses an orthopedic device for offloading weight from a portion of a subject's foot (col 1 lines 8-13) comprising: a single, continuous support pillar (platform 6; fig 8 shows that the platform 6 is a single, continuous structure), wherein the support pillar (6) is configured to extend across only a portion of a plantar surface of a subject's foot (as shown in fig 9; in preferred embodiments it extends from the hindfoot 26 into the midfoot 24; see col 4 line 65 – col 5 line 11 and fig 4); an upper assembly extending vertically from at least a portion of the support pillar (boot shown in fig 9), wherein the upper assembly is configured to wrap around at least a portion of the subject's leg (flaps 52 wrap around the leg as shown in fig 9) and at least a dorsal portion of the foot (flaps 50 wrap over the dorsal part of the foot as shown in fig 9); a means for securing the orthopedic device to the foot of the subject (straps 44 that secure flaps 50 around the foot as shown in fig 9); and a means for securing the orthopedic device to the leg of the subject (straps 44 that secure flaps 52 around the leg as shown in fig 9).
Kopelman does not, however, explicitly disclose that the support pillar comprises a posterior extension configured for extending lengthwise behind the heel.
Grimes, however, teaches an orthopedic device which comprises a sole support that has a heel end that is configured to extend beyond a heel of the wearer's foot when the splint is worn (claims 2 and 18). 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 support pillar of Kopelman so that it comprises a posterior extension configured for extending lengthwise behind the heel, like the sole support of Grimes, in order to provide added support to the heel region of the foot during use. Additionally, one would have been motivated to make such a modification since it would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
With respect to claim 3, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses a foot covering configured to enclose at least a portion of the subject's foot therein (flaps 50 wrap around the foot to enclose part of the foot as shown in fig 9).
With respect to claim 4, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses an outsole (sole 8) that is disposed below the support pillar (sole 8 is disposed below platform 6 as shown in fig 9) and is configured to extend in the anterior direction beyond the anterior-most portion of the support pillar (sole 8 extends forwardly towards the user’s toes beyond the platform 6 as shown in fig 9).
With respect to claim 5, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses that the subject's foot comprises a hindfoot, a midfoot, and a forefoot (inherent anatomical features of a human foot), and the length of the support pillar is configured to contact only the hindfoot of the subject and a portion of the midfoot (as shown in fig 9, platform 6 extends under the hindfoot and midfoot but does not extend to the forefoot or under the toes).
With respect to claim 6, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 5) but does not explicitly disclose that the length of the support pillar is configured to contact the hindfoot, but not the midfoot and forefoot. Kopelman does, however, disclose that the “platform 6 can extend varying degrees in length to encompass more or less of the foot” (col 4 lines 65-66). 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 length of the pillar on the device of Kopelman in view of Grimes so that it is configured to contact the hindfoot, but not the midfoot and forefoot since Kopelman recognizes that the length can be varied to accommodate more or less of the foot as needed to meet the specific treatment requirements of a given user.
With respect to claim 14, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses that the means for securing the orthopedic device to the foot of the subject comprises one or more foot straps (straps 44; fig 9); and the means for securing the orthopedic device to the foot of the subject comprises one or more leg straps (straps 44; fig 9).
With respect to claim 15, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses that the device comprises a shoe or a boot (figure 9 shows the device configured as a boot).
With respect to claim 16, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses a method of off-loading weight to a given portion of a subject's foot (used for post-operative off-loading of the forefoot – col 1 lines 11-12; see also col 4 lines 30-31), comprising: providing the subject with the orthopedic device and instructing the subject to wear the device for a given amount of time (the device is provided to a user and worn by the user as shown in fig 9; the device is provided to a patient by a physician that is treating the patient and is configured such that the physician is allowed access to the wounded portion of the foot while the patient is being treated – col 5 lines 5-11; it is inherent that the physician instructs the patient to wear the device for a given amount of time during treatment – this amount of time includes the instances where the physician needs access to the wounded portion of the foot as described in column 5).
With respect to claim 17, Kopelman in view of Grimes discloses the method substantially as claimed (see rejection of claim 16) and Kopelman also discloses that the subject has been diagnosed with a podiatric condition, and the given amount of time comprises the time required for the podiatric condition to substantially heal (the device is described as being configured to allow support for assisting in the stabilization and proper healing of ulcerative or pre-ulcerative conditions, post-operative off-loading of forefoot, wounds on the foot, or other conditions of the foot, especially for diabetic patients – col 1 lines 8-13; thus, the patient/user is diagnosed as having a podiatric condition such as, i.e. ulcerative or pre-ulcerative conditions, post-operative off-loading of forefoot, wounds on the foot, and the device is used for an amount of time which provides “proper healing” of the condition).
With respect to claim 18, Kopelman in view of Grimes discloses the method substantially as claimed (see rejection of claim 17) and Kopelman also discloses that the podiatric condition comprises a surgical procedure involving the foot or an ulceration of the foot (col 1 lines 8-13).
With respect to claim 19, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses a method of treating a plantar condition in a forefoot of a subject (used for post-operative off-loading of the forefoot – col 1 lines 11-12; see also col 4 lines 30-31), comprising: providing the subject with the orthopedic device and instructing the subject to wear the device until the plantar condition is substantially healed (the device is provided to a user and worn by the user as shown in fig 9; the device is described as being configured to allow support for assisting in the stabilization and proper healing of ulcerative or pre-ulcerative conditions, post-operative off-loading of forefoot, wounds on the foot, or other conditions of the foot, especially for diabetic patients – col 1 lines 8-13; thus, the patient/user is diagnosed as having a plantar condition such as, i.e. post-operative off-loading of forefoot, and the device is used for an amount of time which provides “proper healing” of the condition).
With respect to claim 20, Kopelman in view of Grimes discloses the method substantially as claimed (see rejection of claim 19) and Kopelman also discloses that the plantar condition comprises a surgical procedure involving the foot or an ulceration of the foot (col 1 lines 8-13).
Claim(s) 1 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over DeToro et al (US 6464659) in view of Grimes (US 2016/0338868).
With respect to claim 1, DeToro discloses an orthopedic device (orthopedic foot and ankle brace 11 shown in fig 2) for offloading weight from a portion of a subject's foot (in the configuration shown in fig 2, the insert 10 is configured such that the forefoot is suspended above the member 22 as described in col 3 lines 33-37 which is interpreted as being a configuration that offloads weight from the forefoot) comprising: a single, continuous support pillar (insert 10; fig 2), wherein the support pillar (10) is configured to extend across only a portion of a plantar surface of a foot of a subject (insert 10 extends across only the hindfoot and midfoot as shown in fig 2); an upper assembly extending vertically from at least a portion of the support pillar (fabric foot enclosure 25 shown in fig 2), wherein the upper assembly is configured to wrap around at least a dorsal portion of the subject's foot (sleeve 26 of enclosure 25 wraps around the dorsal part of the foot as shown in fig 2) a means for securing the orthopedic device to the foot of the subject (straps 28 with buckles 29; col 2 lines 22-27; fig 2); and a means for securing the orthopedic device to the leg of the subject (leg strap and buckle assembly 31 – col 2 lines 26-29; fig 2).
DeToro also discloses that the insert 10 can be adjusted in size (col 3 lines 36-44) but does not, however, explicitly disclose that the support pillar comprises a posterior extension configured for extending lengthwise behind the heel.
Grimes, however, teaches an orthopedic device which comprises a sole support that has a heel end that is configured to extend beyond a heel of the wearer's foot when the splint is worn (claims 2 and 18). 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 support pillar of DeToro so that it comprises a posterior extension configured for extending lengthwise behind the heel, like the sole support of Grimes, in order to provide added support to the heel region of the foot during use. Additionally, one would have been motivated to make such a modification since it would have involved a mere change in the size of a component which is generally recognized as being within the level of ordinary skill in the art.
With respect to claim 7, DeToro in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and DeToro also discloses that the support pillar (10) comprises a bottom portion (36) and a top portion (37), and the bottom portion of the support pillar (lower surface 36 of insert 10) comprises a length (length of the lower surface 36 of insert 10 is illustrated with respect to the user’s foot in fig 2) that is different from a length of the top portion of the support pillar (length of the upper surface 37 of insert 10 is illustrated with respect to the user’s foot in fig 2; as shown in fig 2, the length of surface 37 is less than the length of surface 36).
With respect to claim 8, DeToro in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 7) and DeToro also discloses that the length of the bottom portion (36) of the support pillar (10) is at least about 3/5 the length of the top portion (37) of the support pillar (10) (as shown in fig 2, the bottom portion 36 has a length which is greater than the length of the top portion 37 – thus the length of portion 36 is “at least about” 3/5 the length of portion 37 since it is actually longer than portion 37).
With respect to claim 9, DeToro in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 7) and DeToro also discloses that the length of the top portion (37) of the support pillar (10) is at least about 3/5 the length of the bottom portion (36) of the support pillar (10) (as shown in fig 2, portion 37 is illustrated as having a length that is approximately 75% of the length of portion 36; 75% (i.e. 3/4) is greater than 3/5 (i.e. 60%) and thus is “at least about” 3/5 the length).
With respect to claim 10, DeToro in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 7) and DeToro also discloses that the support pillar (10) further comprises a front side (side closest to the user’s toes in fig 2) and a back side (side located near heel in fig 2); the back side of the bottom portion being substantially orthogonal to the back side of the top portion (as shown in fig 2, the sides of each of the surfaces 36 and 37 that is near the heel in fig 2 are orthogonal to each other) and either: the front side of the top portion extends in the anterior direction beyond the front side of the bottom portion such that the front side comprises an angular slope that extends outwardly from the bottom portion to the top portion (as shown in the arrangement in fig 1); or the front side of the bottom portion extends in the anterior direction beyond the front side of the top portion such that the front side comprises an angular slope that extends outwardly from the top portion to the bottom portion (as shown in fig 2).
Claim(s) 2, 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kopelman (US 8402678) in view of Grimes (US 2016/0338868) and further in view of Bledsoe et al (US 2005/0172517).
With respect to claim 2, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) and Kopelman also discloses the upper assembly (boot, fig 9) further comprising: at least one pair of opposing leg flaps (flaps 52) and at least one pair of opposing foot flaps (flaps 50); wherein: the means for securing the orthopedic device to the foot of the subject is configured to join the at least one pair of opposing foot flaps (straps 44 that secure flaps 50 around the foot as shown in fig 9), and the means for securing the orthopedic device to the leg of the subject is configured to join the at least one pair of opposing leg flaps (straps 44 that secure flaps 52 around the leg as shown in fig 9).
Kopelman does not, however, disclose at least one strut extending vertically from the support pillar and along an outer surface of the upper assembly.
Bledsoe, however, teaches an orthopedic device that is configured as a boot (as shown in fig 1) which includes at least one strut (struts 38; figs 1-2) extending vertically from a support pillar (walking shell preferably has a pair of upstanding struts, which extend upwards on both sides of the leg, attached to the upturned edges of the shell which serve to secure the walking boot on the leg of the wearer – para [0021]; see figures 1-2) and along an outer surface of an upper assembly (the struts 38 are positioned over an outer surface of the bootie 14 as shown in fig 1). Bledsoe further teaches that the lower leg is fixed in position between and aligned with upright struts 38 such that the downward force of the patient's weight is being applied perpendicular to foot bed 26 of shell 12 (para [0101]). 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 Kopelman in view of Grimes to further include at least one strut extending vertically from the support pillar and along an outer surface of the upper assembly, like on the device of Bledsoe, in order to fix the lower leg of the user in position between and aligned with the upright struts such that the downward force of the patient's weight is being applied perpendicular to support pillar of the device.
With respect to claim 12, Kopelman in view of Grimes discloses the orthopedic device substantially as claimed (see rejection of claim 1) but does not disclose a first strut and a second strut, wherein the first strut is disposed upon a lateral side of the upper assembly and the second strut is disposed upon a medial side of the upper assembly.
Bledsoe, however, teaches an orthopedic device that is configured as a boot (as shown in fig 1) which includes a first strut and a second strut (struts 38; figs 1-2) wherein the first strut is disposed upon a lateral side of the upper assembly and the second strut is disposed upon a medial side of the upper assembly (as shown in fig 2; the walking shell preferably has a pair of upstanding struts, which extend upwards on both sides of the leg, attached to the upturned edges of the shell which serve to secure the walking boot on the leg of the wearer – para [0021]; see figures 1-2). Bledsoe further teaches that the lower leg is fixed in position between and aligned with upright struts 38 such that the downward force of the patient's weight is being applied perpendicular to foot bed 26 of shell 12 (para [0101]). 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 Kopelman in view of Grimes to further include a first strut and a second strut, wherein the first strut is disposed upon a lateral side of the upper assembly and the second strut is disposed upon a medial side of the upper assembly, like on the device of Bledsoe, in order to fix the lower leg of the user in position between and aligned with the upright struts such that the downward force of the patient's weight is being applied perpendicular to support pillar of the device.
With respect to claim 13, Kopelman in view of Grimes and further in view of Bledsoe discloses the orthopedic device substantially as claimed (see rejection of claim 12) and Bledsoe further teaches that the first strut, the second strut, or a combination thereof comprises a rigid or semi-rigid material (the struts 38 are part of shell 12 which is disclosed as being rigid – see i.e. abstract and para [0020]). 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 first and second struts of the device of Kopelman in view of Grimes and further in view of Bledsoe from a rigid material as taught by Bledsoe in order to provide support to the leg and foot of the user.
Response to Amendments/Arguments
Applicant’s amendments and arguments filed 7/18/25 have been fully considered as follows:
Regarding the objections to the claims, Applicant’s amendments have been fully considered and are sufficient to overcome the objections which, accordingly, have been withdrawn.
Regarding the claim interpretation under 35 USC 112f, in the absence of any amendments to remove the limitations or arguments in opposition to the interpretation, the Office continues to interpret the claims as outlined above.
Regarding the claim rejections under 35 USC 101, Applicant’s amendments to the claims have been fully considered and are sufficient to overcome the rejections which, accordingly, have been withdrawn.
Regarding the claim rejections under 35 USC 102 and 35 USC 103, Applicant’s arguments on pages 8-13 have been fully considered but are rendered moot in view of the new grounds of rejection presented above which were necessitated by Applicant’s amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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