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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant's election with traverse of Species A (Fig. 1-8 and 12) in the reply filed on 6/9/2026 is acknowledged. Applicant’s traversal is found persuasive. No claims are withdrawn and the election of species requirement is withdrawn.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6, 10, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schumacher (US 20200054374 A1).
Regarding claim 1, Schumacher discloses a hallux valgus correction brace (Fig. 35-37, implanted brace for hallux valgus/bunions) comprising:
a first insertion piece (10) configured to receive a big toe of a foot (Fig. 35-37 and [0107], first insertion piece 10 receives the first metatarsal 51 being the big toe);
a second insertion (20) piece configured to receive a second toe or a middle toe of the foot (Fig. 35-37 and [0107], second insertion piece 20 receives the second metatarsal 52 being the second toe); and
a gap maintainer (30) coupling the first insertion piece (10) and the second insertion piece (20) (Fig. 35-37 and [0178]),
the gap maintainer (30) being configured to apply an elastic force to the first insertion piece and the second insertion piece in a direction away from each other (Fig. 35-37 and [0178, 0190, 0028, 0177, 0207], gap maintainer 30 includes the flexural feature 100 being a metal elastic feature for elastically moving the toes and pieces 10/20 from each other),
wherein the first insertion piece (10), the second insertion piece (20), and the gap maintainer (30) are integrally formed by an elongated member made of metal (Fig. 35-37, elongated member, [0190] whole brace may be made of metal of the flexure feature).
Regarding claim 2, Schumacher discloses the invention of claim 1 above.
Schumacher further discloses wherein a material of the elongated member includes a nickel-titanium alloy ([0190] elongated member may be made of nitinol being a nickel-titanium alloy).
Regarding claim 4, Schumacher discloses the invention of claim 1 above.
Schumacher further discloses wherein assuming that a direction in which the first insertion piece and the second insertion piece are arranged side by side is defined as a foot-width direction and an insertion direction of the second toe or the middle toe into the second insertion piece is defined as a foot-length direction,
the first insertion piece (10) and the second insertion piece (20) each form a groove opening on one side in an orthogonal direction orthogonal to each of the foot-width direction and the foot-length direction (Fig. 35-37, groove openings of 10/20 facing downward being the one side orthogonal direction as defined).
Regarding claim 5, Schumacher discloses the invention of claim 4 above.
Schumacher further discloses wherein the first insertion piece (10) and the second insertion piece (20) each include an inner end and an outer end forming a pair of edges of the groove (Fig. 35, each piece 10/20 have outer ends defining the ends of the grooves and inner ends being where they each meet with the gap maintainer 30 being a pair of edges of the formed groove), and
the gap maintainer (30) couples the inner end of the first insertion piece and the inner end of the second insertion piece (Fig. 35-37, gap maintainer integral with the “inner ends” of the first/second insertion pieces 10/20).
Regarding claim 6, Schumacher discloses the invention of claim 5 above.
Schumacher further discloses wherein the gap maintainer (30) is disposed on the one side in the orthogonal direction with respect to the outer end of at least one of the first insertion piece or the second insertion piece (Fig. 35-37, gap maintainer 30 has structure that is disposed on the one side of the orthogonal direction being the direction of the groove openings and outer ends of the pieces 10/20).
Regarding claim 10, Schumacher discloses the invention of claim 4 above.
Schumacher further discloses wherein the gap maintainer (30) has an arc shape curved to project on the one side in the orthogonal direction (Fig. 35-37).
Regarding claim 12, Schumacher discloses the invention of claim 4 above.
Schumacher further discloses wherein the elongated member has a plate shape with a predetermined width and a predetermined thickness as being unfolded in the foot-width direction (Fig. 35-37, the elongated member is a plate shape being of the same form as the present application brace with width and thickness therein [0209], being a shape memory nitinol able to be unfolded [0190]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher (US 20200054374 A1) in view of Cachia (US 20050197711 A1).
Regarding claim 3, Schumacher discloses the invention of claim 2 above.
Schumacher is silent on wherein a shape recovery temperature of the nickel-titanium alloy is 32 degrees C or less.
However, Cachia teaches an analogous nitinol implant brace for bunions ([0013, 0024]) wherein the nitinol may have a shape recovery temperature being 32 degrees C or less (see [0027], temperature of shape memory activation is 30 degrees Celsius).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the nitinol shape memory material of Schumacher to have a shape recovery temperature being 32 degrees C or less as taught by Cachia in order to enable the shape memory to be not activated when not yet implanted and to activate when implanted/on the body part being affected by the shape memory material (Cachia [0027]).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher (US 20200054374 A1) in view of Yoshikawa (JP 2006051168 A).
Regarding claim 7, Schumacher discloses the invention of claim 5 above.
Schumacher fails to disclose wherein the gap maintainer includes: a first projection connected to the inner end of the first insertion piece and projecting toward the groove of the first insertion piece; a second projection connected to the inner end of the second insertion piece and projecting toward the groove of the second insertion piece; and a coupler coupling the first projection and the second projection.
However, Yoshikawa teaches an analogous hallux valgus brace (Fig. 1-3 and Abstract) having analogous first and second insertion pieces (2/3) (See Annotated Fig. 1) wherein an analogous gap maintainer (4) (See Annotated Fig. 1) includes:
a first projection connected to the inner end of the first insertion piece and projecting toward the groove of the first insertion piece (See Annotated Fig. 1);
a second projection connected to the inner end of the second insertion piece and projecting toward the groove of the second insertion piece (See Annotated Fig. 1); and
a coupler coupling the first projection and the second projection (See Annotated Fig. 1, coupler being the outer surface material of the gap maintainer 4 connecting the projections).
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Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the shape of the gap maintainer 30 of Schumacher to have the projections and coupler shape as taught by Yoshikawa in order to provide a shape that would better hold the toes for the hallux valgus brace (Yoshikawa Fig. 1 and Pages 2-3 of the translation).
Regarding claim 8, Schumacher in view of Yoshikawa discloses the invention of claim 7 above.
Yoshikawa further teaches wherein the first projection and the second projection each have an arc shape (See Annotated Fig. 1 of Yoshikawa, wherein the projections have an arc shape by both their overall curving shape as well as their ends having a convex arc shape).
Regarding claim 9, Schumacher in view of Yoshikawa discloses the invention of claim 7 above.
Yoshikawa further teaches wherein the coupler has an arc shape curved to project on an other side in the orthogonal direction (See Annotated Fig. 1, wherein the orthogonal one side direction is the direction of the groove openings, wherein as shown the coupler of the gap maintainer 4 has arc shapes formed on both bottom and top sides thus having an arc that projects on both the orthogonal one side as well as arc that projects and curved on an other side of the orthogonal direction)
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher (US 20200054374 A1) in view of Seaman (US 9675491 B1).
Regarding claim 11, Schumacher discloses the invention of claim 5 above.
Schumacher is silent on one or more protective members covering at least an inner surface of the groove of each of the first insertion piece and the second insertion piece.
However, Seaman teaches an analogous hallux valgus brace (title) (Fig. 1-33) comprising an analogous metal insert/brace (Col. 6 lines 35-44 and Fig. 15, metal bracket 23 with spring action for straightening), the brace comprising an analogous insertion piece and inner surface therein for receiving toes of the user therein (Fig. 10, 17-18, 23-24),
wherein the Seaman brace is formed for external wearing (Fig. 1-33) and the metal is thus provided with one or more protective members covering at least an inner surface of the groove of each of the first insertion piece and the second insertion piece (Col. 6 lines 35-44 and Fig. 15, foam provided on the inner and outer surface of the worn brace including the analogous insertion piece and inner surface for receiving toes therein) (Col. 9 lines 5-10, foam provides cushioning of the toes).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the metal implant brace of Schumacher to comprise one or more protective members covering at least an inner surface of the groove of each of the first insertion piece and the second insertion piece as taught by Seaman in order to configure the hallux valgus brace for use as an external brace instead of an implant, the protective members providing cushioning to the toes from the metal insert (Seaman Col. 6 lines 35-44 and Fig. 15 and Col. 9 lines 5-10).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schumacher (US 20200054374 A1) in view of Cachia (US 20050197711 A1).
Regarding claim 13, Schumacher discloses the invention of claim 12 above.
Schumacher is silent on wherein the elongated member has a mesh shape with a plurality of through holes.
However, Sheehan teaches an analogous orthotic brace (Fig. 1-23) having a mesh shape with plurality of through holes 42/46/44 (Fig. 1-23 and [0063], the brace has a plurality of holes 42/46/44 placed all over forming a mesh shape in the brace) (the apertures provide “having relatively larger apertures or relatively greater “openness” so as to reduce the overall amount and weight of material and thus cost and improve breathability” [0062]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the analogous brace orthosis of Schumacher to have a mesh shape with a plurality of through holes as taught by Sheehan in order to reduce the weight and cost of material to manufacture the brace (Sheehan [0062]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 10327823 B2 – hallux valgus implant brace with mesh coating for protection
US 2471997 A – toe brace
US 2818062 A – toe yoke
US 20170056229 A1 – nitinol brace with padding
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEVIN S ALBERS whose telephone number is (571)272-0139. The examiner can normally be reached Monday-Friday 7:30 am to 5:00 pm.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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