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.
Response to Arguments
Applicant’s arguments, see Remarks, filed 9/22/2026, with respect to the rejection(s) of claim(s) 1-13 under Schumacher have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Yoshikawa. As discussed in the interview of 8/28/2026, Examiner acknowledges the discussion of the differences between Schumacher and the current claims.
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.
Claim 2-3 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 2 recites “a material of the elongated member includes a nickel-titanium alloy” wherein claim 1 also recites “an elongated member made of metal” wherein the claim 2 as written makes it unclear if the “metal” of claim 1 is this alloy or if there are two different materials being the metal and the NiTi alloy. Examiner will interpret this broadly as such these being the same material as recited.
Claim 3 is rejected as being dependent on claim 2.
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, 4-10, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yoshikawa (JP 2006051168 A).
Regarding claim 1, Yoshikawa discloses a hallux valgus correction brace 1 (Fig. 1, Abstract, for treating hallux valgus) comprising:
a first insertion piece 2 configured to receive a big toe of a foot (See Annotated Fig. 1);
a second insertion piece 3 configured to receive a second toe or a middle toe of the foot (See Annotated Fig. 1); and
a gap maintainer 4 coupling the first insertion piece 2 and the second insertion piece 3 (See Annotated Fig. 1),
the gap maintainer 4 being configured to apply an elastic force to the first insertion piece 1 and the second insertion piece 2 in a direction away from each other (See Annotated Fig. 1, and Page 3, there is a force to spread between the toes, and the toe brace herein is formed of materials having elasticity in order to create such force, see further Page 5 which discusses the entire toe ring 1 being made of an elastic body wherein the material therein creates the force applied between the toes in order to correct hallux valgus),
wherein the first insertion piece 1, the second insertion piece 2, and the gap maintainer 4 are integrally formed by an elongated member (See Annotated Fig 1, wherein the brace is an elongated integrally formed device) made of metal (See Page 5-6, wherein the elastic soft material may be a metal with the same properties of elastic force application for correcting hallux valgus).
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Regarding claim 4, Yoshikawa discloses the invention of claim 1 above.
Yoshikawa 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 2 and the second insertion piece 3 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 (See Annotated Fig. 1, wherein there is a formed groove opening for each of the toes to enter through into the pieces 2 and 3 on the one side therein of the device that is orthogonal to the claimed foot-width direction and the foot-length direction).
Regarding claim 5, Yoshikawa discloses the invention of claim 4 above.
Yoshikawa discloses wherein the first insertion piece 2 and the second insertion piece 3 each include an inner end and an outer end forming a pair of edges of the groove (See Annotated Fig. 1), and
the gap maintainer 4 couples the inner end of the first insertion piece 2 and the inner end of the second insertion piece 3 (See Annotated Fig. 1).
Regarding claim 6, Yoshikawa discloses the invention of claim 5 above.
Yoshikawa discloses wherein the gap maintainer 4 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 2 or the second insertion piece 3 (See Annotated Fig. 1, wherein the projections of the gap maintainer 4 are disposed on the same one side as the outer ends of the pieces 2/3).
Regarding claim 7, Yoshikawa discloses the invention of claim 5 above.
Yoshikawa discloses wherein the gap maintainer 4 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).
Regarding claim 8, Yoshikawa discloses the invention of claim 7 above.
Yoshikawa discloses 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, Yoshikawa discloses the invention of claim 7 above.
Yoshikawa discloses 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).
Regarding claim 10, Yoshikawa discloses the invention of claim 4 above.
Yoshikawa discloses wherein the gap maintainer 4 has an arc shape curved to project on the one side in the orthogonal direction (See Annotated Fig. 1, wherein the projections of the gap maintainer 4 form an arc shape that projects on the one side).
Regarding claim 12, Yoshikawa discloses the invention of claim 4 above.
Yoshikawa discloses wherein the elongated member (Fig. 1) has a plate shape (Fig. 1b, shows the elongated member being a flat plate shape) with a predetermined width (Fig. 1a, shows a width “a” of the elongated member) and a predetermined thickness (Fig. 1b, “e” being a thickness) as being unfolded in the foot-width direction (Fig. 1, shows the invention in an unattached and thus “unfolded” state with Fig. 1b showing the foot-width direction for the thickness therein).
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) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa (JP 2006051168 A) in view of Palmer (US 20170056229 A1).
Regarding claim 2, Yoshikawa discloses the invention of claim 1 above.
Yoshikawa is silent on wherein a material of the elongated member includes a nickel-titanium alloy.
However, Palmer teaches an analogous orthotic for correcting toe deformities (Abstract) being analogously formed of an elastic material to correct such toe deformities ([0010-0011, 0039]), wherein Palmer teaches such elastic material to be a metal being nickel-titanium alloy ([0010-0011, 0039, 0047], Nitinol).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the elastic/metal material of the elongated member of Yoshikawa to be/include nickel-titanium alloy as taught by Palmer in order to provide an improved elastic shape memory force for correcting the toe deformity of hallux valgus as such Nitinol nickel-titanium alloy results in a better resultant toe alignment (Palmer ([0010-0011, 0039, 0047]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa (JP 2006051168 A) in view of Palmer (US 20170056229 A1) in view of Cachia (US 20050197711 A1).
Regarding claim 3, Yoshikawa/Palmer discloses the invention of claim 2 above.
Yoshikawa/Palmer as combined 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 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 Yoshikawa/Palmer 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 at room temperature/not yet placed on the body and to activate when on the body part being affected by the shape memory material due to the material warming to the body temperature of the user (Cachia [0027]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yoshikawa (JP 2006051168 A) in view of Seaman (US 9675491 B1).
Regarding claim 11, Yoshikawa discloses the invention of claim 5 above.
Yoshikawa 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 brace of Yoshikawa 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 allow improved cushioning onto the toes when the brace is being worn (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 Yoshikawa (JP 2006051168 A) in view of Sheehan (US 20190269558 A1).
Regarding claim 13, Yoshikawa discloses the invention of claim 12 above.
Yoshikawa 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 Yoshikawa 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
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael Bredefeld can be reached at (571) 270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
