DETAILED ACTION
This is the initial Office action for non-provisional application 18/774,645 filed July 16, 2024, which is a continuation of non-provisional application 18/384,372 (now US Patent 12,042,417) filed October 26, 2023, which is filed as a divisional of non-provisional application 16/997,925 (now US Patent 11,872,151) filed August 19, 2020, which was filed as a continuation-in-part of non-provision application 15/977,880 (now US Patent 11,484,426) filed May 11, 2018, and claims priority from provisional applications 63/059,580 filed July 31, 2020, 62/990,726 filed March 17, 2020, 62/980,743 filed February 24, 2020, 62/889,720 filed August 21, 2019, 62/625,893 filed February 2, 2018, and 62/505,740 filed May 12, 2017. Claims 2-21, as filed December 30, 2024, are currently 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 . 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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosures of the prior-filed applications 62/505,740, 62/625,893, 15/977,880, 62/889,720, 62/980,743, 62/990,726, and 63/059,580 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 2-21 are directed to an ankle foot orthosis (AFO) comprising a spiral strut which is not supported by the prior-filed applications 62/505,740, 62/625,893, 15/977,880, and 62/889,720.
Claims 2-7 and 14-21 require that the trimmable portion of the foot plate has a thickness dimension that is smaller than the non-trimmable portion which is not support by the prior-filed applications 62/505,740, 62/625,893, 15/977,880, 62/889,720, 62/980,743, 62/990,726, and 63/059,580.
Claims 8-13 require that at least a portion of the transition portion of the spiral strut is curved in a plane parallel with portions of the top surface of the foot plate which is not support by the prior-filed applications 62/505,740, 62/625,893, 15/977,880, 62/889,720, 62/980,743, 62/990,726, and 63/059,580.
For at least these reasons, claims 2-21 are not entitled to the benefit of all of the prior-filed applications and for purposes of applicable prior art, claims 2-27 and have the effective filing date of August 19, 2020 (the filing date of prior-filed application 16/997,925, the earliest application that can provide sufficient support to all of the claimed limitations).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-13 and 20 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7, 8, and 20 each recite the limitation “the spiral straight”; however, there is insufficient antecedent basis for this limitation in the claims. For examination purposes, the limitation “the spiral straight” has been interpreted as “the spiral strut”.
Claims 9-13 are included in the rejection under 35 U.S.C. 112(b) based on their dependence from rejected claim 8.
Claim Rejections - 35 USC § 103
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.
Claims 2-4, 14, 15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay (US 2016/0213552) in view of Siewert et al. (US 2019/0110917).
Regarding claim 2, Lindsay discloses an ankle foot orthosis (AFO) (integrated offloading device 10/110) comprising a foot plate (plate portion 12b), a spiral strut (stem portion 12a/112a) coupled with a side region of the foot plate (12b) away from a mid-line of the foot plate (12b) at an interface region, the spiral strut (12a/112a) comprising a transition portion that spirals toward the mid-line of the foot plate (12b) to an adjustable portion of the spiral strut (12a/112a), the AFO (10/110) consisting of only one spiral strut (12a/112a), and a cuff (shin support structure 14/114) that is height adjustable over the adjustable portion of the spiral strut (12a/112a) (Figs. 1a-1b, 3-4, & 11; ¶ 0061-0062, 0065, & 0082-0085).
However, Lindsay fails to teach that the foot plate comprises a trimmable portion and a non-trimmable portion, the trimmable portion of the foot plate having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion of the foot plate.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), wherein the trimmable portion (10) of the foot plate (2) has a thickness dimension between a top surface (upper side 26) and a bottom surface (underside 24) of the foot plate (2) that is smaller in dimension than the non-trimmable portion of the foot plate (2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6) (Figs. 1-3 & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by Lindsay such that foot plate includes a trimmable portion and a non-trimmable portion, the trimmable portion having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion as taught by Siewert for the purpose of adapting the length of the foot plate to a user and providing a contoured edge of the foot plate after trimming.
Regarding claims 3 and 4, the combination of Lindsay and Siewert discloses the invention substantially as claimed, as described above, and Siewert further discloses that the trimmable portion (10) of the foot plate (2) shares a common surface with the non-trimmable portion of the foot plate (2) on a top surface (upper side 26) of the foot plate (2), wherein a curved surface is present between the non-trimmable portion of the foot plate (2) and the trimmable portion (10) of the foot plate (2) on a bottom opposing region (underside 24) of the foot plate (2) opposite from the top surface (26) of the foot plate (2) (Figs. 1-3, 8-9, 13-14, & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by the combination of Lindsay and Siewert such that the foot plate has common surface between the trimmable portion and the non-trimmable portion on a top surface thereof and the foot plate has curved surface between the trimmable portion and the non-trimmable portion on a bottom opposing region of the foot plate opposite from the top surface as further taught by Siewert for the purpose of providing a smooth surface on which a user’s foot contact the foot plate.
Regarding claim 14, Lindsay discloses an ankle foot orthosis (AFO) (integrated offloading device 10/110) comprising a foot plate (plate portion 12b), a spiral strut (stem portion 12a/112a) coupled with a side region of the foot plate (12b) away from a mid-line of the foot plate (12b) at an interface region, the spiral strut (12a/112a) comprising a transition portion that spirals toward the mid-line of the foot plate (12b) to an adjustable portion of the spiral strut (12a/112a), the AFO (10/110) consisting of only one spiral strut (12a/112a), and a cuff (shin support structure 14/114) that is height adjustable over the adjustable portion of the spiral strut (12a/112a) (Figs. 1a-1b, 3-4, & 11; ¶ 0061-0062, 0065, & 0082-0085).
However, Lindsay fails to teach that the foot plate comprises a trimmable portion and a non-trimmable portion, the trimmable portion of the foot plate having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion of the foot plate.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), wherein the trimmable portion (10) of the foot plate (2) has a thickness dimension between a top surface (upper side 26) and a bottom surface (underside 24) of the foot plate (2) that is smaller in dimension than the non-trimmable portion of the foot plate (2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6), wherein the trimmable portion (10) of the foot plate (2) shares a common surface with the non-trimmable portion of the foot plate (2) on a top surface (upper side 26) of the foot plate (2), and wherein a curved surface is present between the non-trimmable portion of the foot plate (2) and the trimmable portion (10) of the foot plate (2) on a bottom opposing region (underside 24) of the foot plate (2) opposite from the top surface (26) of the foot plate (2) (Figs. 1-3, 8-9, 13-14, & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by Lindsay such that foot plate includes a trimmable portion and a non-trimmable portion, the trimmable portion having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion, the foot plate has common surface between the trimmable portion and the non-trimmable portion on the top surface, and the foot plate has curved surface between the trimmable portion and the non-trimmable portion on the bottom surface as taught by Siewert for the purpose of adapting the length of the foot plate to a user and providing a contoured edge of the foot plate after trimming and a smooth surface on which a user’s foot contact the foot plate.
Regarding claim 15, the combination of Lindsay and Siewert discloses the invention substantially as claimed, as described above, and Lindsay further discloses that the interface region in which the spiral strut (12a/112a) is coupled with the side region of the foot plate (12b) is located on a lateral side of the foot plate (12b) (Fig. 1b).
Regarding claim 19, the combination of Lindsay and Siewert discloses the invention substantially as claimed, as described above, and Lindsay further discloses that at least a portion of the transition portion of the spiral strut (12a/112a) is curved in a plane that is parallel with portions of the top surface of the foot plate (12b) (Figs. 1a-1b).
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay in view of Siewert as applied to claims 2-4 above, and in further view of Bialowons et al. (US 2020/0352771).
Regarding claim 5, the combination of Lindsay and Siewert discloses the invention substantially as claimed, as described above, and Siewert further discloses that the trimmable portion (10) of the foot plate (2) is located in portions anterior to a hindfoot region of the foot plate (2), wherein at least a portion of the trimmable portion (10) of the foot plate (2) is located on an opposing side region of the foot plate (2) that is opposite from the side region of the foot plate (2) where the strut (3+4) is coupled with the foot plate (2) (Fig. 3; the weakenings 10 extend from one side region of the foot plate 2 to another side region of the foot plate 2).
However, the combination of Lindsay and Siewert fails to teach that the trimmable portion of the foot plate is located in a hindfoot region of the foot plate as well.
Bialowons discloses an ankle foot orthosis (AFO) comprising a foot plate (foot plate 10) comprising a trimmable portion (outside of markings 50) located in both a hindfoot region (heel region 11) of the foot plate (10) as well as portions (front foot region 12) anterior to the hindfoot region (11) of the foot plate (10), wherein at least a portion of the trimmable portion (50) located in the hindfoot region (11) of the foot plate (10) is located posterior from an interface region between a strut (strut 20) and the foot plate (10) (Fig. 1; ¶ 0009-0011 & 0026).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the foot plate of the ankle foot orthosis taught by the combination of Lindsay and Siewert to include trimmable portions located in the hindfoot region of the foot plate posterior from the interface region as taught by Bialowons for the purpose of adapting the length of the hindfoot region of the foot plate to a user's foot.
Regarding claim 6, the combination of Lindsay / Siewert / Bialowons discloses the invention substantially as claimed, as described above, and Lindsay further discloses that at least a portion of the transition portion of the spiral strut (12a/112a) is curved in a plane that is parallel with portions of the top surface of the foot plate (12b) (Figs. 1a-1b).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Lindsay in view of Siewert as applied to claims 2-4 above, in further view of Bialowons as applied to claims 5 and 6 above, and in even further view of Romo et al. (US 10,561,514).
The combination of Lindsay / Siewert / Bialowons discloses the invention substantially as claimed, as described above, but fails to clearly teach that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate.
Romo discloses an ankle foot orthosis (orthosis 117) comprising a foot plate (footplate 119), a strut (strut 123) coupled with the foot plate (119), and a cuff (securing device 125) that is height adjustable over an adjustable portion of the strut (123), wherein the adjustable portion of the strut (123) comprises a rectangular cross section (Fig. 17) in a plane that is parallel with portions of a top surface of the foot plate (119) (Figs. 14-17; column 18, lines 49-57 & 65-66; column 20, lines 23-47).
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by the combination of Lindsay / Siewert / Bialowons such that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate as taught by Romo since Applicant has not disclosed that such a shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a strut for an ankle foot orthosis. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lindsay (US 2016/0213552), in view of Siewert et al. (US 2019/0110917), and in further view of Romo et al. (US 10,561,514).
Lindsay discloses an ankle foot orthosis (AFO) (integrated offloading device 10/110) comprising a foot plate (plate portion 12b), a spiral strut (stem portion 12a/112a) coupled with a side region of the foot plate (12b) away from a mid-line of the foot plate (12b) at an interface region, the spiral strut (12a/112a) comprising a transition portion that spirals toward the mid-line of the foot plate (12b) to an adjustable portion of the spiral strut (12a/112a), the AFO (10/110) consisting of only one spiral strut (12a/112a), and a cuff (shin support structure 14/114) that is height adjustable over the adjustable portion of the spiral strut (12a/112a), wherein at least a portion of the transition portion of the spiral strut (12a/112a) is curved in a plane that is parallel with portions of the top surface of the foot plate (12b) (Figs. 1a-1b, 3-4, & 11; ¶ 0061-0062, 0065, & 0082-0085).
However, Lindsay fails to teach that the foot plate comprises a trimmable portion and a non-trimmable portion.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6) (Figs. 1-3 & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by Lindsay such that foot plate includes a trimmable portion and a non-trimmable portion as taught by Siewert for the purpose of adapting the length of the foot plate to a user.
However, the combination of Lindsay and Siewert fails to clearly teach that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate.
Romo discloses an ankle foot orthosis (orthosis 117) comprising a foot plate (footplate 119), a strut (strut 123) coupled with the foot plate (119), and a cuff (securing device 125) that is height adjustable over an adjustable portion of the strut (123), wherein the adjustable portion of the strut (123) comprises a rectangular cross section (Fig. 17) in a plane that is parallel with portions of a top surface of the foot plate (119) (Figs. 14-17; column 18, lines 49-57 & 65-66; column 20, lines 23-47).
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by the combination of Lindsay and Siewert such that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate as taught by Romo since Applicant has not disclosed that such a shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a strut for an ankle foot orthosis. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lindsay in view of Siewert as applied to claims 14 and 19 above, and in further view of Romo et al. (US 10,561,514).
Regarding claim 20, the combination of Lindsay and Siewert discloses the invention substantially as claimed, as described above, but fails to clearly teach that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate.
Romo discloses an ankle foot orthosis (orthosis 117) comprising a foot plate (footplate 119), a strut (strut 123) coupled with the foot plate (119), and a cuff (securing device 125) that is height adjustable over an adjustable portion of the strut (123), wherein the adjustable portion of the strut (123) comprises a rectangular cross section (Fig. 17) in a plane that is parallel with portions of a top surface of the foot plate (119) (Figs. 14-17; column 18, lines 49-57 & 65-66; column 20, lines 23-47).
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by the combination of Lindsay and Siewert such that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate as taught by Romo since Applicant has not disclosed that such a shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a strut for an ankle foot orthosis. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 21, the combination of Lindsay / Siewert / Romo discloses the invention substantially as claimed, as described above, but fails to clearly teach that the trimmable portion of the foot plate enables an overall length of the foot plate to be trimmed by at least 75 mm. However, such a limitation depends on the starting length of the foot plate and the desired final length of the foot plate after being trimmed which will depend on dimensions of a particular user’s foot.
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the ankle foot orthosis taught by the combination of Lindsay / Siewert / Romo such that the trimmable portion of the foot plate enables an overall length of the foot plate to be trimmed by at least 75 mm since it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (US 6,676,618) in view of Siewert et al. (US 2019/0110917).
Regarding claim 14, Andersen discloses an ankle foot orthosis (AFO) comprising a foot plate (foot plate 10), a spiral strut (narrow connecting member 12) coupled with a side region of the foot plate (10) away from a mid-line of the foot plate (10) at an interface region, the spiral strut (12) comprising a transition portion that spirals toward the mid-line of the foot plate (10) to an adjustable portion of the spiral strut (12), the AFO consisting of only one spiral strut (12), and a cuff (calf abutment member 11) that is height adjustable over the adjustable portion of the spiral strut (12) (Figs. 7-8; column 4, lines 14-30; column 5, lines 5-14).
However, Andersen fails to teach that the foot plate comprises a trimmable portion and a non-trimmable portion, the trimmable portion of the foot plate having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion of the foot plate.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), wherein the trimmable portion (10) of the foot plate (2) has a thickness dimension between a top surface (upper side 26) and a bottom surface (underside 24) of the foot plate (2) that is smaller in dimension than the non-trimmable portion of the foot plate (2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6), wherein the trimmable portion (10) of the foot plate (2) shares a common surface with the non-trimmable portion of the foot plate (2) on a top surface (upper side 26) of the foot plate (2), and wherein a curved surface is present between the non-trimmable portion of the foot plate (2) and the trimmable portion (10) of the foot plate (2) on a bottom opposing region (underside 24) of the foot plate (2) opposite from the top surface (26) of the foot plate (2) (Figs. 1-3, 8-9, 13-14, & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by Andersen such that foot plate includes a trimmable portion and a non-trimmable portion, the trimmable portion having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion, the foot plate has common surface between the trimmable portion and the non-trimmable portion on the top surface, and the foot plate has curved surface between the trimmable portion and the non-trimmable portion on the bottom surface as taught by Siewert for the purpose of adapting the length of the foot plate to a user and providing a contoured edge of the foot plate after trimming and a smooth surface on which a user’s foot contact the foot plate.
Regarding claim 15, the combination of Andersen and Siewert discloses the invention substantially as claimed, as described above, and Andersen further discloses that the interface region in which the spiral strut (12) is coupled with the side region of the foot plate (10) is located on a lateral side of the foot plate (10) (Fig. 4).
Regarding claim 16, the combination of Andersen and Siewert discloses the invention substantially as claimed, as described above, and Andersen further discloses that the spiral strut (12) is configured to extend along a posterior portion of a user’s leg (Figs. 7-8). Although the combination of Andersen and Siewert fails to expressly teach that the adjustable portion of the spiral strut is located in a posterior portion of the AFO, it would have been an obvious matter of design choice to one having ordinary skill in the art to modify the ankle foot orthosis taught by the combination of Andersen and Siewert such that the adjustable portion of the spiral strut is located in a posterior portion of the AFO since it has been held that rearranging parts of an invention that would not have modified the operation of the device involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
Claims 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bader (US 2017/0216071), in view of Siewert et al. (US 2019/0110917), and in further view of Romo et al. (US 10,561,514).
Regarding claim 14, Bader discloses an ankle foot orthosis (AFO) (deformity alignment device 10) comprising a foot plate (lower foot support or platform 16), a spiral strut (elongated spiral configured interconnecting member 12) coupled with a side region of the foot plate (16) away from a mid-line of the foot plate (16) at an interface region, the spiral strut (12) comprising a transition portion that spirals toward the mid-line of the foot plate (16) to an adjustable portion of the spiral strut (12), the AFO consisting of only one spiral strut (12), and a cuff (upper calf cuff 14) (Figs. 1-4; ¶ 0035-0036).
However, Bader fails to teach that the foot plate comprises a trimmable portion and a non-trimmable portion, the trimmable portion of the foot plate having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion of the foot plate.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), wherein the trimmable portion (10) of the foot plate (2) has a thickness dimension between a top surface (upper side 26) and a bottom surface (underside 24) of the foot plate (2) that is smaller in dimension than the non-trimmable portion of the foot plate (2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6), wherein the trimmable portion (10) of the foot plate (2) shares a common surface with the non-trimmable portion of the foot plate (2) on a top surface (upper side 26) of the foot plate (2), and wherein a curved surface is present between the non-trimmable portion of the foot plate (2) and the trimmable portion (10) of the foot plate (2) on a bottom opposing region (underside 24) of the foot plate (2) opposite from the top surface (26) of the foot plate (2) (Figs. 1-3, 8-9, 13-14, & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis taught by Bader such that foot plate includes a trimmable portion and a non-trimmable portion, the trimmable portion having a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion, the foot plate has common surface between the trimmable portion and the non-trimmable portion on the top surface, and the foot plate has curved surface between the trimmable portion and the non-trimmable portion on the bottom surface as taught by Siewert for the purpose of adapting the length of the foot plate to a user and providing a contoured edge of the foot plate after trimming and a smooth surface on which a user’s foot contact the foot plate.
However, the combination of Bader and Siewert fails to teach that the cuff is height adjustable over the adjustable portion of the spiral strut.
Romo discloses an ankle foot orthosis (orthosis 117) comprising a foot plate (footplate 119), a strut (strut 123) coupled with the foot plate (119), and a cuff (securing device 125) that is height adjustable over an adjustable portion of the strut (123) (Figs. 14-17; column 18, lines 49-57 & 65-66; column 20, lines 23-47).
Therefore, it would have been obvious to one having ordinary skill in the art, to modify the ankle foot orthosis taught by the combination of Bader and Siewert such that the cuff is height adjustable over the adjustable portion of the spiral strut as taught by Romo for the purpose of accommodating users with different tibial lengths.
Regarding claim 17, the combination of Bader / Siewert / Romo discloses the invention substantially as claimed, as described above, and Bader further discloses that the interface region in which the spiral strut (12) is coupled with the side region of the foot plate (16) is located on a medial side of the foot plate (16) (Fig. 2; ¶ 0028).
Regarding claim 18, the combination of Bader / Siewert / Romo discloses the invention substantially as claimed, as described above, and Romo further discloses that the adjustable portion of the strut (123) is located in a posterior portion of the AFO (117) (Figs. 14-17).
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art to modify the ankle foot orthosis taught by the combination of Bader / Siewert / Romo such that the adjustable portion of the spiral strut is located in a posterior portion of the AFO as further taught by Romo since it has been held that rearranging parts of an invention that would not have modified the operation of the device involves only routine skill in the art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950).
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 2-6 and 14-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9, 10, 13, and 14 of US Patent 12,042,417 (reference patent ‘417) in view of Siewert et al. (US 2019/0110917).
Regarding claim 2, the limitations therein are substantially recited in claim 1 of reference patent ‘417 including an ankle foot orthosis (AFO) comprising a foot plate comprising a trimmable portion and a non-trimmable portion, a spiral strut coupled with a side region of the foot plate away from a mid-line of the foot plate at an interface region, the spiral strut comprising a transition portion that spirals towards the mid-line of the foot plate to an adjustable portion of the spiral strut, the AFO consisting on only one spiral strut, and a cuff that is height adjustable over the adjustable portion of the spiral strut.
Although claim 6 of reference patent ‘417 recites a concaved junction is disposed on at least a portion of an interface between the trimmable portion and the non-trimmable portion, the claims of reference patent ‘417 do not recite that the trimmable portion of the foot plate has a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion of the foot plate.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), wherein the trimmable portion (10) of the foot plate (2) has a thickness dimension between a top surface (upper side 26) and a bottom surface (underside 24) of the foot plate (2) that is smaller in dimension than the non-trimmable portion of the foot plate (2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6) (Figs. 1-3 & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis recited in the claims of reference patent ‘417 such that the trimmable portion of the foot plate has a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension that the non-trimmable portion of the foot plate as taught by Siewert for the purpose of providing a contoured edge of the foot plate after trimming.
Regarding claim 3, the limitations therein are substantially recited in claim 6 of reference patent ‘417 and Siewert further discloses that the trimmable portion (10) of the foot plate (2) shares a common surface with the non-trimmable portion of the foot plate (2) on the top surface (26) of the foot plate (2) (Fig. 17).
Regarding claim 4, Siewert further discloses that a curved surface is present between the non-trimmable portion of the foot plate (2) and the trimmable portion (10) of the foot plate (2) on a bottom opposing region of the foot plate (2) opposite from the top surface (26) of the foot plate (2) (Fig. 8-9 & 13-14).
Regarding claim 5, the limitations therein are substantially recited in claims 2 and 3 of reference patent ‘417 and Siewert further discloses that at least a portion of the trimmable portion (10) of the foot plate (2) is located on an opposing side region of the foot plate (2) that is opposite from the side region of the foot plate (2) where the strut (3+4) is coupled with the foot plate (2) (Fig. 3; the weakenings 10 extend from one side region of the foot plate 2 to another side region of the foot plate 2).
Regarding claim 6, the limitations therein are substantially recited in claims 4 and 5 of reference patent ‘417.
Regarding claim 14, the limitations therein are substantially recited in claims 1 and 6 of reference patent ‘417 including an ankle foot orthosis (AFO) comprising a foot plate comprising a trimmable portion and a non-trimmable portion, the trimmable portion of the foot plate shares a common surface with the non-trimmable portion of the foot plate, and a curved surface (concaved junction) between the non-trimmable portion of the foot plate and the trimmable portion of the foot plate, a spiral strut coupled with a side region of the foot plate away from a mid-line of the foot plate at an interface region, the spiral strut comprising a transition portion that spirals towards the mid-line of the foot plate to an adjustable portion of the spiral strut, the AFO consisting on only one spiral strut, and a cuff that is height adjustable over the adjustable portion of the spiral strut.
However, the claims of reference patent ‘417 do not recite that the trimmable portion of the foot plate has a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion of the foot plate, the common surface is on the top surface of the foot plate, and the curved surface is on a bottom opposing region of the foot plate opposite from the top surface of the foot plate.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), wherein the trimmable portion (10) of the foot plate (2) has a thickness dimension between a top surface (upper side 26) and a bottom surface (underside 24) of the foot plate (2) that is smaller in dimension than the non-trimmable portion of the foot plate (2), the trimmable portion (10) of the foot plate (2) shares a common surface with the non-trimmable portion of the foot plate (2) on the top surface (26) of the foot plate (2), and a curved surface is present between the non-trimmable portion of the foot plate (2) and the trimmable portion (10) of the foot plate (2) on a bottom opposing region of the foot plate (2) opposite from the top surface (26) of the foot plate (2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6) (Figs. 1-3, 8-9, 13-14, & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis recited in the claims of reference patent ‘417 such that the trimmable portion of the foot plate has a thickness dimension between a top surface and a bottom surface of the foot plate that is smaller in dimension than the non-trimmable portion of the foot plate, the common surface is on the top surface of the foot plate, and the curved surface is on a bottom opposing region of the foot plate opposite from the top surface of the foot plate as taught by Siewert for the purpose of providing a contoured edge of the foot plate after trimming and a smooth surface on which a user’s foot contact the foot plate.
Regarding claim 15, the limitations therein are substantially recited in claim 9 of reference patent ‘417.
Regarding claim 16, the limitations therein are substantially recited in claim 10 of reference patent ‘417.
Regarding claim 17, the limitations therein are substantially recited in claim 13 of reference patent ‘417.
Regarding claim 18, the limitations therein are substantially recited in claim 14 of reference patent ‘417.
Regarding claim 19, the limitations therein are substantially recited in claims 4 and 5 of reference patent ‘417.
Claims 7, 20, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of US Patent 12,042,417 (reference patent ‘417) in view of Siewert as applied to claims 2-6, 14, and 19 above, and in further view of Romo et al. (US 10,561,514).
Regarding claims 7 and 20, the limitations therein are substantially recited in the claims of reference patent ‘417 as modified by Siewert, as described above, except for that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate.
Romo discloses an ankle foot orthosis (orthosis 117) comprising a foot plate (footplate 119), a strut (strut 123) coupled with the foot plate (119), and a cuff (securing device 125) that is height adjustable over an adjustable portion of the strut (123), wherein the adjustable portion of the strut (123) comprises a rectangular cross section (Fig. 17) in a plane that is parallel with portions of a top surface of the foot plate (119) (Figs. 14-17; column 18, lines 49-57 & 65-66; column 20, lines 23-47).
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis recited in the claims of reference patent ‘417 as modified by Siewert such that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate as taught by Romo since Applicant has not disclosed that such a shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a strut for an ankle foot orthosis. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 21, although the claims of reference patent ‘417 as modified by Siewert and Romo fails to recite that the trimmable portion of the foot plate enables an overall length of the foot plate to be trimmed by at least 75 mm, such a limitation depends on the starting length of the foot plate and the desired final length of the foot plate after being trimmed which will depend on dimensions of a particular user’s foot. Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the ankle foot orthosis recited in the claims of reference patent ‘417 as modified by Siewert and Romo such that the trimmable portion of the foot plate enables an overall length of the foot plate to be trimmed by at least 75 mm since it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claims 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 7, and 8 of US Patent 12,042,417 (reference patent ‘417) in view of Romo et al. (US 10,561,514).
Regarding claim 8, the limitations therein are substantially recited in claims 1, 4, and 5 of reference patent ‘417 including an ankle foot orthosis (AFO) comprising a foot plate comprising a trimmable portion and a non-trimmable portion, a spiral strut coupled with a side region of the foot plate away from a mid-line of the foot plate at an interface region, the spiral strut comprising a transition portion that spirals towards the mid-line of the foot plate to an adjustable portion of the spiral strut, the AFO consisting on only one spiral strut, and a cuff that is height adjustable over the adjustable portion of the spiral strut, wherein at least a portion of the transition portion of the spiral strut is curved in a plane that is parallel with portions of a top surface of the footplate.
However, the claims of reference patent ‘417 fails to recite that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate.
Romo discloses an ankle foot orthosis (orthosis 117) comprising a foot plate (footplate 119), a strut (strut 123) coupled with the foot plate (119), and a cuff (securing device 125) that is height adjustable over an adjustable portion of the strut (123), wherein the adjustable portion of the strut (123) comprises a rectangular cross section (Fig. 17) in a plane that is parallel with portions of a top surface of the foot plate (119) (Figs. 14-17; column 18, lines 49-57 & 65-66; column 20, lines 23-47).
Therefore, it would have been an obvious matter of design choice to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis recited in the claims of reference patent ‘417 as modified by Siewert such that the adjustable portion of the spiral strut comprises a rectangular cross section in a plane that is parallel with the portions of the top surface of the foot plate as taught by Romo since Applicant has not disclosed that such a shape solves any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a strut for an ankle foot orthosis. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 9, the limitations therein are substantially recited in claim 7 of reference patent ‘417.
Regarding claim 10, the limitations therein are substantially recited in claim 8 of reference patent ‘417.
Regarding claim 11, although the claims of reference patent ‘417 as modified by Romo fails to recite that the trimmable portion of the foot plate enables an overall length of the foot plate to be trimmed by at least 75 mm, such a limitation depends on the starting length of the foot plate and the desired final length of the foot plate after being trimmed which will depend on dimensions of a particular user’s foot. Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to construct the ankle foot orthosis recited in the claims of reference patent ‘417 as modified by Romo such that the trimmable portion of the foot plate enables an overall length of the foot plate to be trimmed by at least 75 mm since it has been held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984).
Claims 12 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of US Patent 12,042,417 (reference patent ‘417) in view of Romo as applied to claims 8-11 above, and in further view of Siewert et al. (US 2019/0110917).
The limitations therein are substantially recited in claim 6 of reference patent ‘417. However, the claims of reference patent ‘417 as modified by Romo fails to teach that the common surface is on a top surface of the foot plate and the curved surface is on a bottom opposing region of the foot plate opposite from the top surface of the foot plate.
Siewert discloses an ankle foot orthosis (orthotic 1) comprising a foot plate (foot plate 2) comprising a trimmable portion (weakenings 10) and a non-trimmable portion (remainder of foot plate 2), a strut (foot support 3 + lower leg support bar 4) coupled with a side region of the foot plate (2) away from a mid-line of the foot plate at an interface region, and a cuff (fastening means 6), wherein the trimmable portion (10) of the foot plate (2) shares a common surface with the non-trimmable portion of the foot plate (2) on a top surface (upper side 26) of the foot plate (2), and wherein a curved surface is present between the non-trimmable portion of the foot plate (2) and the trimmable portion (10) of the foot plate (2) on a bottom opposing region (underside 24) of the foot plate (2) opposite from the top surface (26) of the foot plate (2) (Figs. 1-3, 8-9, 13-14, & 17; ¶ 0012, 0018, 0044, 0051, & 0061).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the ankle foot orthosis recited in the claims of reference patent ‘417 as modified by Romo such that the common surface is on a top surface of the foot plate and the curved surface is on a bottom opposing region of the foot plate opposite from the top surface of the foot plate as taught by Siewert for the purpose of providing a smooth surface on which a user’s foot contact the foot plate.
Allowable Subject Matter
Claims 9-13 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of base claim 8 and any intervening claims. Further, a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) would need be filed to overcome the nonstatutory double patenting rejection over US Patent 12,042,417.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 4/9/2026