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 .
Election/Restrictions
Applicant’s election without traverse of Species III in the reply filed on 2/26/2026 is acknowledged.
Claims 1-20 are currently pending and being examined.
Priority
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 disclosure of the prior-filed application, Application No. 16789048, fails 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. The prior filed application does not provide support for “a first bi-lateral heel strap operable to couple to the body near a lateral side of a heel of the wearer and at a medial side of the body above the ankle of the wearer; and a second bi-lateral heel strap operable to couple to the body near a medial side of the heel and at a lateral side of the body above the ankle; wherein the first bi-lateral heel strap is operable to wrap around a hindfoot and the ankle of the wearer; and wherein the second bi-lateral heel strap is operable to wrap around the hindfoot and the ankle” as recited in claim 1. Accordingly, claims 1-20 are not entitled to the benefit of the prior application.
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 14-20 are 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.
Claim 14 recites “wrapping the first bi-lateral heel strap around the wearer by extending the first bi- lateral heel strap from the lateral side of the heel, around the ankle, around the hindfoot, and around the ankle to the medial side of the body above the ankle; and wrapping the second bi-lateral heel strap around the wearer by extending the second bi-lateral heel strap from the medial side of the heel, around the ankle, around the hindfoot, and around the ankle to the lateral side of the body above the ankle”. This is unclear in light of the specification because it is inconsistent with what is disclosed. Applicant’s disclosure shows first and second bi-lateral heel straps that extend from one side of the brace to the other. See for example Figure 30 where strap 501 extends from the lateral side and then In Figure 32 is wrapped over the foot and attached to the medial side. Similarly straps 505 extends from the medial side and is wrapped and attached to the lateral side. The claim, however, recites the first bi-lateral heel strap around the wearer by extending the first bi- lateral heel strap from the lateral side of the heel, around the ankle, around the hindfoot, and around the ankle to the medial side of the body above the ankle; and wrapping the second bi-lateral heel strap around the wearer by extending the second bi-lateral heel strap from the medial side of the heel, around the ankle, around the hindfoot, and around the ankle to the lateral side of the body above the ankle”. It is unclear if it is required to wrap around the ankle twice or if this is an oversite in claim construction given that the drawing do not appear to support such wrapping. Applicant’s specification also discloses “the method can include wrapping the first bi-lateral heel strap around the wearer by extending the first bi-lateral heel strap from the lateral side of the heel, around the ankle, around the midfoot, and around the ankle to the medial side of the body above the ankle. At a seventh step, the method can include wrapping the second bi-lateral heel strap around the wearer by extending the second bi-lateral heel strap from the medial side of the heel, around the ankle, around the midfoot, and around the ankle to the lateral side of the body above the ankle”. This is inconsistent with the claimed limitations and drawings for similar reasons. Therefore, it is unclear what is intended to be the scope of the claim.
The remaining claims are rejected due to their dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 4-5, 7-9, and 11-13 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 4 recites “wherein the medial countervailing force strap extends from the medial side near the second aperture, over the foot to a lateral side of the body, and under the foot to the medial side near the first aperture” which positively recites the human body.
Claim 7 recites “wherein the lateral countervailing force strap extends from the lateral side near the second aperture, over the foot to a medial side of the body, and under the foot to the lateral side near the first aperture” which positively recites the human body.
Claim 11 recites “wherein the first bi- lateral heel strap and the second bi-lateral heel strap provide additional control of inversion/eversion movement of a forefoot of the wearer” which positively recites the human body.
Claim 12 recites “wherein the additional control provided by the first bi-lateral heel strap and second bi-lateral heel strap prevents excess inversion/eversion, excess pronation/supination, and excess dorsiflexion/plantarflexion” which positively recites the human body.
Claim 13 recites “wherein the first bi-lateral heel strap crosses the second bi-lateral heel strap near the hindfoot” which positively recites the human body.
It is suggested applicant use “configured to” or similar language to obviate the rejection.
The remaining claims are rejected due to their dependency.
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.
Claims 1-8 and 10-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon Jr et al (US 2006/0211968 A1) in view of Vogelbach (US 4,844,058).
Regarding claim 1, Gordon discloses in Figures 2-8 and [0027] a body (sock like body 110) comprising: a first aperture (at 120) operable to receive a foot of a wearer, the first aperture above an ankle of the wearer in use (in which the user’s leg is shown in Figure 2 to be positioned); a second aperture (at 122 in which the user’s foot is shown in Figures 2 and 3 to be positioned) operable to receive the foot of the wearer, the second aperture at an opposite end of the body from the first aperture (Figure 2); a medial countervailing force strap (medial strap 500) operable to couple to the body near a medial side of the first aperture and near a medial side of the second aperture (Figure 4); a lateral countervailing force strap (lateral strap 600) operable to couple to the body near a lateral side of the first aperture and near a lateral side of the second aperture (Figure 6). Gordon does not disclose a first bi-lateral heel strap operable to couple to the body near a lateral side of a heel of the wearer and at a medial side of the body above the ankle of the wearer; and a second bi-lateral heel strap operable to couple to the body near a medial side of the heel and at a lateral side of the body above the ankle; wherein the first bi-lateral heel strap is operable to wrap around a hindfoot and the ankle of the wearer; and wherein the second bi-lateral heel strap is operable to wrap around the hindfoot and the ankle. However, Vogelbach teaches in Figures 1-8 an analogous device with a first bi-lateral heel strap (16) operable to couple to the body near a lateral side of a heel of the wearer and at a medial side of the body above the ankle of the wearer (Figures 3-5; Col, 3, lines 44-53); and a second bi-lateral heel strap (14) operable to couple to the body near a medial side of the heel and at a lateral side of the body above the ankle (Figures 3-5; Col. 3, lines 53-66); wherein the first bi-lateral heel strap is operable to wrap around a hindfoot and the ankle of the wearer (Figures 3-5; Col, 3, lines 44-53); and wherein the second bi-lateral heel strap is operable to wrap around the hindfoot and the ankle (Figures 3-5; Col. 3, lines 53-66). It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the brace of Gordon to include heel straps taught by Vogelbach for providing additional resisting forces to the rear of the ankle joint (Col. 3, lines 39-66).
Regarding claim 2, Vogelbach further teaches wherein the first bi- lateral heel strap and the second bi-lateral heel strap are operable to secure a subtalar joint of the wearer in subtalar neutral (strap 16 resists inversion of the calcaneus and supination of the subtalar joint and strap 14 is positioned to resist eversion and anteromedial forces (subtalar pronation); Col. 3, lines 43-60), thereby protecting posterior and anterior tabula fibular and calcaneus fibular ligaments associated with ankle injuries (Figures 7-8; Col. 3, lines 39-66).
Regarding claim 3, Gordon discloses wherein the medial countervailing force strap is operable to wrap around the foot of the wearer (Figures 2-4).
Regarding claim 4, Gordon discloses wherein the medial countervailing force strap (500) extends from the medial side near the second aperture (Figure 2), over the foot to a lateral side of the body (as shown at 510 in Figure 4), and under the foot (Figure 7 shows the extension 520 of strap 500 being wrapped underneath the wearer’s arch to a medial side thereof) to the medial side near the first aperture (Figure 4 shows the extension 530 of strap 500 being extended vertically to a position above the user’s ankle joint) (note: this is a recitation of intended use).
Regarding claim 5, Gordon discloses wherein the medial countervailing force strap (500) includes a fastener (532) operable to couple to a corresponding fastener (316) of the body at the lateral side of the body (fastener 532 is capable of attaching to 316 on the lateral side ([0032]-[0033]).
Regarding claim 6, Gordon wherein the lateral countervailing force strap (600) is operable wrap to around the foot of the wearer (Figures 5-8).
Regarding claim 7, Gordon discloses wherein the lateral countervailing force strap extends from the lateral side near the second aperture (Figure 4), over the foot to a medial side of the body (Figure 5), and under the foot (Figure 7) to the lateral side near the first aperture (Figures 6 and 8).
Regarding claim 8, Gordon discloses wherein the lateral countervailing force strap (600) includes a fastener (632) operable to couple to a corresponding fastener (316’) of the body at the medial side of the body (fastener 632 is capable of attaching to 316’ on the medial side ([0032]-[0033]).
Regarding claim 10, Gordon discloses wherein the medial countervailing force strap (medial strap 500) and the lateral countervailing force strap (lateral strap 600) are operable to provide countervailing forces along the foot and ankle to resist excessive supination and pronation thereof ([0034] teaches “the medial 500 and lateral 600 straps present countervailing forces beginning at the metatarsal heads, along the forefoot and upward along the ankle joint complex” and “straps 500, 600 thus present countervailing forces in these regions so as to resist movement of the ankle and foot, inclusive of its underlying structures, from excessive pronation or supination”).
Regarding claim 11, Vogelbach further teaches wherein the first bi- lateral heel strap and the second bi-lateral heel strap provide additional control of inversion/eversion movement of a forefoot of the wearer (Figures 7-8; Col. 3, lines 39-66).
Regarding claim 12, Vogelbach further discloses wherein the additional control provided by the first bi-lateral heel strap and second bi-lateral heel strap prevents excess inversion/eversion, excess pronation/supination, and excess dorsiflexion/plantarflexion (Figures 7-8; Col. 3, lines 39-66).
Regarding claim 13, Vogelbach further teaches wherein the first bi- lateral heel strap crosses the second bi-lateral heel strap near the hindfoot (Figure 7).
Regarding claim 14, Gordon discloses a method for preventing excessive supination and/or pronation of an ankle ([0034] teaches “the medial 500 and lateral 600 straps present countervailing forces beginning at the metatarsal heads, along the forefoot and upward along the ankle joint complex” and “straps 500, 600 thus present countervailing forces in these regions so as to resist movement of the ankle and foot, inclusive of its underlying structures, from excessive pronation or supination”), the method comprising: providing the foot and ankle stabilizing brace of claim 1 (see rejection of claim 1 above); extending the foot through the first aperture (Figure 3); extending the foot through the second aperture (Figure 3); wrapping the lateral countervailing force strap around the foot by extending the lateral countervailing force strap (400) from the lateral side near the second aperture (Figure 4) to a medial side of the body (Figure 5), underneath an arch to the lateral side of the body (Figure 7), and up the lateral side of the body near first aperture (Figures 6 and 8); wrapping the medial countervailing force strap (500) around the foot by extending the medial countervailing force strap from the medial side near the second aperture (Figure 2) to a lateral side of the body (Figure 4), underneath an arch of the wearer (Figure 7) to the medial side of the body (Figure 4), and up the medial side of the body near the first aperture (Figure 4). Gordon does not disclose wrapping the first bi-lateral heel strap around the wearer by extending the first bi-lateral heel strap from the lateral side of the heel, around the ankle, around the hindfoot, and around the ankle to the medial side of the body above the ankle; and wrapping the second bi-lateral heel strap around the wearer by extending the second bi-lateral heel strap from the medial side of the heel, around the ankle, around the hindfoot, and around the ankle to the lateral side of the body above the ankle. Vogelbach teaches a similar device and method for preventing excessive pronation and/or supination, (Figures 7-8; Col. 3, lines 39-66) by wrapping the first bi-lateral heel strap (16) around the wearer by extending the first bi-lateral heel strap from the lateral side of the heel (Figure 3), around the ankle, around the hindfoot, and around the ankle to the medial side of the body above the ankle (Figure 4; Col. 3, lines 44-53); and wrapping the second bi-lateral heel strap (14) around the wearer by extending the second bi-lateral heel strap from the medial side of the heel (Figure 3), around the ankle, around the hindfoot, and around the ankle to the lateral side of the body above the ankle (Figure 5; Col. 3, lines 54-65). It would have been obvious to one having ordinary skill in the art before the effective filing of the present invention to modify the brace and method of Gordon and wrap the heel straps as taught by Vogelbach for providing additional resisting forces to the rear of the ankle joint (Col. 3, lines 39-66).
Regarding claim 15, Vogelbach further teaches wherein the first bi- lateral heel strap and the second bi-lateral heel strap are operable to secure a subtalar joint of the wearer in subtalar neutral (strap 16 resists inversion of the calcaneus and supination of the subtalar joint and strap 14 is positioned to resist eversion and anteromedial forces (subtalar pronation); Col. 3, lines 43-60), thereby protecting posterior and anterior tabula fibular and calcaneus fibular ligaments associated with ankle injuries (Figures 7-8; Col. 3, lines 39-66).
Regarding claim 16, Gordon discloses wherein the medial countervailing force strap (medial strap 500) and the lateral countervailing force strap (lateral strap 600) are operable to provide countervailing forces along the foot and ankle to resist excessive supination and pronation thereof ([0034] teaches “the medial 500 and lateral 600 straps present countervailing forces beginning at the metatarsal heads, along the forefoot and upward along the ankle joint complex” and “straps 500, 600 thus present countervailing forces in these regions so as to resist movement of the ankle and foot, inclusive of its underlying structures, from excessive pronation or supination”).
Regarding claim 17, Vogelbach further teaches wherein the first bi- lateral heel strap and the second bi-lateral heel strap provide additional control of inversion/eversion movement of a forefoot of the wearer (Figures 7-8; Col. 3, lines 39-66).
Regarding claim 18, Vogelbach further discloses wherein the additional control provided by the first bi-lateral heel strap and second bi-lateral heel strap prevents excess inversion/eversion, excess pronation/supination, and excess dorsiflexion/plantarflexion (Figures 7-8; Col. 3, lines 39-66).
Regarding claim 19, Vogelbach further teaches wherein the first bi-lateral heel strap crosses the second bi-lateral heel strap near the hindfoot (Figure 7).
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gordon Jr et al (US 2006/0211968 A1) in view of Vogelbach (US 4,844,058) in view of Gaylord et al (US 2009/0112140 A1).
Regarding claims 9 and 20, Gordon and Vogelbach teach that as disclosed above. Gordon discloses a tongue (260) and fastener tab (230) to secure the body and tongue around the foot of the wearer ([0029]). Gordon does not disclose a set of laces. Gaylord teaches a similar ankle stabilizing apparatus having a set of laces (18) to secure the body and tongue around the foot and teaches the laces are a suitable alternative to other connectors capable of drawing the front edges together ([0075]). It would have been obvious to one of ordinary skill in the art at the time of filing to substitute the fastener tab of Gordon with the laces as taught by Gaylord as being a suitable alternative fastener for securing the body member and would allow for easy fine tune adjustment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. McVeigh (US 1134442), Johnson (US 6641550), Couch (US 6142967), and Arensdorf (US 5676641) disclose similar ankle stabilizing braces.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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