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 .
Claims 22-41 are currently pending and are being examined.
Specification
The specification is objected to because reference characters 11 and 13 are used interchangeably for both the lateral shell section and a medial shell section on page 7.
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 24, 26, 32, and 40 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.
The term “at least mostly” in claim 24 is a relative term which renders the claim indefinite. The term “at least mostly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 26 recites “the at least one strap section comprises at least two stacked layers… the first layer is connected to a second layer formed by the textile section”. It is unclear if the second layer is one of the two stacked layers of the strap section or the textile section. If it is part of the textile section, it is unclear if there still need to be two stacked layers in addition to the textile section. It is noted that claim 25 requires both a strap section and a textile section.
Claim 32 recites the limitation "each transition area" in line 1 and “the lateral/medial shell section” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the limitation the “lateral/medial” shell section is indefinite since it is unclear which one (or both) is required.
Regarding claim 40, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 23-30 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 is dependent on claim 1 which has been cancelled. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The remaining claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 22 and 33-41 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schrijver (WO 98/29060).
Regarding claim 22, Schrijver discloses an ankle support (Figure 1) including a one-piece shell comprising: a lateral shell section (11); a medial shell section (2) that is larger than the lateral shell section (medial shell section 2 is larger in at least the width direction due to the additional stiffening element 16; Figure 2), the medial shell section including an elongated reinforced zone (16, 17) for providing support in the ankle support, wherein the lateral shell section is less stiff than the medial shell section (Col. 1, lines 58-67; Abstract; Col. 2, line 28 to Col. 3, line 4); and a sole shell section (8) connecting the lateral shell section and the medial shell section; wherein: the medial shell section (2) includes a medial edge configured to extend upwards from the sole shell section along the medial side of lower leg and defining an open recess (4) in the medial shell section for receiving the medial malleolus (Figure 1; Col. 2, lines 28-40); and the lateral shell section (11) includes a lateral edge configured to extend upwards from the sole shell section along the lateral side of the lower leg (Figure 3) and the lateral shell section defining an open recess (14) in the lateral shell section for receiving the lateral malleolus (Figure 3).
Regarding claim 33, Schrijver discloses wherein circumferential edges of the one-piece shell are more flexible than the elongated reinforced zone of the medial shell section (inner/lower elastic material 22; Col. 2, line 49-Col. 3, line 7).
Regarding claim 34, Schrijver discloses wherein the medial shell section and the lateral shell section together define a heel recess (7; Figures 1-3).
Regarding claim 35, Schrijver discloses wherein the medial shell section and the lateral shell section merge into another at a position above the heel recess (Figures 1 and 3).
Regarding claim 36, Schrijver discloses wherein in use, the one-piece shell is configured to leave a front part of a lower leg free such that the one-piece shell provides a semi-rigid frame defining an open instep space for receiving a foot and a lower leg of a user (10; Figures 1 and 3; Col. 2, lines 41-45).
Regarding claim 37, Schrijver discloses wherein the sole shell section comprises a reinforced sole zone (8) that extends between the medial and lateral shell sections, and wherein the reinforced sole zone is stiffer than the lateral shell section (portion of 13 that extends below heel 6 and is stiffer than at least the elastic shell part of 11; Col. 2, lines 49-63).
Regarding claim 38, Schrijver discloses wherein the elongated reinforced zone of the medial shell section is stiffer than the reinforced sole zone (stiffening element 16 is stiffer than 13 at the sole; Col. 2, line 28 to Col. 3, line 4).
Regarding claim 39, Schrijver discloses wherein the elongated reinforced zone of the medial shell section extends from or proximal to the sole shell section along the medial malleolus further upwards (Figure 1).
Regarding claim 40, Schrijver discloses wherein the one-piece shell is made by multi-material injection molding for creating a single-structure part with different regional materials or different regional material properties, for example the elongated reinforced zone providing a relatively stiff medial shell section with respect to the lateral shell section (Col. 1, lines 58-67; Abstract). It is noted the device of Schrijver appear to be substantially identical to the device claimed, although produced by a different process. Therefore, the burden is upon the applicant to come forward with evidence establishing an unobvious difference between the two. In re Marosi, 218 USPQ 289 (Fed. Cir. 1983).
Regarding claim 41, Schrijver discloses wherein the lateral shell section comprises at least one zone that is stiffer than another zone of the lateral shell section and is less stiff than the elongated reinforced zone of the medial shell section (13 is stiffer than the underlying elastic material but less stiff than 16 of the medial shell section; Figures 1 and 3; Col. 2, line 49-Col. 3, line 4).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Schrijver (WO 98/29060) in view of Voskuilen et al (US 2017/0165094 A1).
Regarding claim 31, Schrijver discloses (although does not explicitly show) a strap connected to the sole shell section and attaching to medial and lateral shell sections (at adhering pieces 19, 20; (Figures 1-3; Col. 3, lines 12-16) but does not disclose the strap includes two strap portions wherein one of the two strap portions or one of the two straps is connected proximal to the sole shell section to the lateral shell section, and the other of the two strap portions or the other of the two straps is connected proximal to the sole shell section to the medial shell section. Voskuilen teaches an ankle-foot orthosis having a strap (23) that includes two strap portions wherein one of the two strap portions or one of the two straps is connected proximal to the sole shell section to the lateral shell section, and the other of the two strap portions or the other of the two straps is connected proximal to the sole shell section to the medial shell section (Figures 2 and 4). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the strap of Scrijver that was disclosed but not explicitly shown, and provide two strap portions wherein one of the two strap portions is connected proximal to the sole shell section to the lateral shell section, and the other of the two strap portions is connected proximal to the sole shell section to the medial shell section as shown and taught by Voskuilen to secure the orthosis on the user’s foot.
Regarding claim 32, Schrijver further discloses wherein each transition area of the one-piece shell between the lateral and medial shell section and the sole shell section includes at least one notch for guiding the strap or strap portion to the lateral/medial shell section such that a part of the strap or strap portion is connectable to the lateral and medial shell section (Figures 1 and 3; see notch between sole section 9 and front of medial and lateral shell sections 2, 11).
Claims 23-30 are rejected under 35 U.S.C. 103 as being unpatentable over Schrijver (WO 98/29060) in view of McCormick et al (US 6,929,617 B2).
Regarding claim 23, Schrijver discloses that as applied above wherein at least a portion of the lateral edge is connected to a cover (band attached to adhering pieces 20, Figures 2-3; Col. 3, lines 12-16). Schrijver does not disclose the cover is elastic. McCormick teaches an ankle brace wherein the straps are elastic (13; Col, 5, lines 62-Col. 6, line 16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the cover of Schrijver being elastic as taught by McCormick for providing comfortable support when wrapping around the foot of the user.
Regarding claim 24, Schrijver discloses wherein the lateral edge is at least mostly connected to the elastic cover (band attached to adhering pieces 20, Figures 2-3; Col. 3, lines 12-16).
Regarding claim 25, Schrijver in view of McCormick teach that as applied above. Schrijver does not disclose wherein the elastic cover comprises at least one strap section and a textile section, and wherein the textile section is more elastic than the at least one strap section (Col. 5 line 62 to Col. 6 line 16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the cover of Schrijver comprising a strap and textile section as taught by McCormik for providing support and wicking properties.
Regarding claim 26, Schrijver in view of McCormick teach that as applied above. Schrijver does not disclose wherein the at least one strap section comprises at least two stacked layers; a first layer of the at least two stacked layers is less elastic than the textile section; and the first layer is connected to a second layer formed by the textile section. Schrijver teaches the at least one strap section comprises at least two stacked layers (34, 36); a first layer (36) of the at least two stacked layers is less elastic than the textile section (35); and the first layer is connected to a second layer formed by the textile section (35; Figure 6; Col. 5 line 62 to Col. 6 line 16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the cover of Schrijver comprising the strap and textile section as taught by McCormik for providing support and wicking properties.
Regarding claim 27, Schrijver in view of McCormick teach that as applied above. Schrijver does not disclose wherein the textile section comprises a double folded textile. McCormick teaches wherein the textile section comprises a double folded textile (34, 35; Figure 6; Col. 5 line 62 to Col. 6 line 16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the cover of Schrijver comprising the strap and textile section as taught by McCormik for providing support and wicking properties.
Regarding claim 28, Schrijver in view of McCormick teach that as applied above. Schrijver does not disclose wherein an edge of the elastic cover, between the portion to be releasably connected to the upper portion of the medial shell section and the lateral edge, is provided by a fold line of the double folded textile of the textile section. McCormick teaches wherein an edge of the elastic cover, between the portion to be releasably connected to the upper portion of the medial shell section and the lateral edge, is provided by a fold line of the double folded textile of the textile section (34, 35; Figures 1, 3, and 6; Col. 5 line 62 to Col. 6 line 16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the cover of Schrijver comprising the strap and textile section as taught by McCormik for providing support and wicking properties.
Regarding claim 29, Schrijver in view of McCormick teach that as applied above. Schrijver does not disclose wherein an edge area of the elastic cover, extending between the sole section and the portion of the elastic cover to be releasably connected to the upper portion of the medial shell section, is provided by the at least one strap section. McCormick teaches wherein an edge area of the elastic cover, extending between the sole section and the portion of the elastic cover to be releasably connected to the upper portion of the medial shell section, is provided by the at least one strap section (36; Figures 1, 3, and 6; Col. 5 line 62 to Col. 6 line 16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the cover of Schrijver comprising the strap and textile section as taught by McCormik for providing support and wicking properties.
Regarding claim 30, Schrijver in view of McCormick teach that as applied above. Schrijver does not disclose wherein a further edge area of the elastic cover, connected to the lateral edge of the lateral shell section, is formed by the at least one strap section. McCormick teaches wherein a further edge area of the elastic cover, connected to the lateral edge of the lateral shell section, is formed by the at least one strap section (36; Figures 1, 3, and 6; Col. 5 line 62 to Col. 6 line 16). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the cover of Schrijver comprising the strap and textile section as taught by McCormik for providing support and wicking properties.
Conclusion
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786