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
Claims 10-15 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/11/2026.
Applicant’s election without traverse of invention I, claims 1-9 and 16-19, in the reply filed on 2/11/2026 is acknowledged.
Drawings
The drawings are objected to because Figures 1 and 2 are misaligned leaving labels on blank pages and images with incorrect labels. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 objected to because of the following informalities:
Line 9: “customize” should read “customized”.
Claim 7 objected to because of the following informalities:
Line 3: “portion” should read “portions”.
Appropriate correction is required.
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 5, 7-9, and 16-19 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 5 recites the limitation "the final moldable putty" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim should read “a final moldable material” or “a final moldable putty”. The “moldable material” has not been claimed to be a “putty” prior to this claim as well as “the final” version of the material.
Claims 7-9 are rejected on their dependent basis on claim 5.
Claim 16 recites the limitation "the moldable putty" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim should read “the moldable material” or “a moldable putty”.
Claim 17-19 recites the limitation "the customized orthotic device" while being dependent on claim 9. There is insufficient antecedent basis for this limitation in the claim. For terms of examination, the claims are being understood as dependent on claim 16 rather than claim 9 to better match the preamble.
Claim 17 recites the limitation "the final moldable putty" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim should read “a final moldable material” or “a final moldable putty”.
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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by FR2353276 (Herein “Royer”).
Regarding Claim 1, Royer discloses a customizable prosthetic device (See Fig 1 for prosthetic device 1), comprising:
a footplate (See Fig 2 reinforcement sole 10); and
a contoured prosthetic cap assembly (See Fig 2 for side view of prosthetic device 1), comprising:
a prosthetic cap component (See Fig 2 for surface 5 of housing 3 which has rough shape of front of foot similar to prosthetic cap component), and
a moldable material component (See Fig. 2 for the molded element 2 which is shaped by surface 5), wherein the moldable material component can be formed and contoured to an interfacing portion of an amputated appendage (See Fig. 2 for the molded element 2 which is shaped by surface 5 and inner surface 4 of housing 3) while resting on a top of the footplate (See fig 2 reinforcement sole 10), wherein the moldable material component can then be cured (see [14] for hardening of moldable element 2) and fastened to the prosthetic cap component to form a customized prosthetic appendage, wherein the customize prosthetic appendage can then be fastened to the footplate (See [29] for housing 3 and moldable element 2 being coupled to reinforcement sole 10).
Regarding Claim 2, Royer discloses the device of claim 1, further comprising an enclosure system configured to provide a lateral barrier around the customized prosthetic appendage when being contoured to the amputated appendage (See Fig 2 for surface 5 in combination with lateral flange 7).
Regarding Claim 3, Royer discloses the device of claim 2, wherein the enclosure system is adjustable (See Fig 2 flange 7 which is elastic and in eyelets 11 to allow for adjustable stretch).
Regarding Claim 4, Royer discloses the device of claim 3, wherein the enclosure system comprises a first portion and a second portion, wherein the first portion is removably couplable from the second portion (See Fig 2 flange 7 which is elastic and in eyelets 11 which are parts of 5 so they can be removed).
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) 5-7 and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over FR2353276 (Herein “Royer”) in view of US 20110265348 A1 (Herein “Schmutte”).
Regarding Claim 5, Royer does not teach the use of a putty, however Schmutte which teaches of molding a shoe insert to the shape of the foot discloses:
moldable material is provided in two parts that are mixed together to form the final moldable putty (See [61] for two mixable putties that when combined form the final putty to be cured).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to use mixable putties of Schmutte with the prosthetic disclosed by Royer
as Schmutte teaches that the use of the mixable putties allows for molding without the need for specialized tools (See [61]).
Regarding Claim 6, Royer does not teach silicone as a material for the moldable element however Schmutte further discloses:
wherein the moldable material is comprised of a silicone-based material (See [63] for putty to be made of silicone).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to use the silicone putties of Schmutte with the moldable element disclosed by Royer as Schmutte teaches that the use of silicone material allows for quick chemically curing and precise contour (See [29]).
Regarding Claim 7, Royer discloses the device of claim 5, further comprising a wrapping material configured to be applied to the moldable material and the prosthetic cap component to couple the respective portion together (See [13] for hardening varnish covers the surface 5 and hardening component).
Regarding Claim 16, Royer discloses
A customized orthotic device (See Fig 1 for prosthetic device 1), the device comprising:
a moldable material capable of curing to a final shape (See Fig. 2 for the molded element 2 which is shaped by surface 5); and
a footplate (See Fig 2 reinforcement sole 10), wherein the moldable [material] is configured for placement on the footplate to generally replace any anatomical features normally present on a footplate (See [29] for housing 3 and moldable element 2 being coupled to reinforcement sole 10).
Royer does not teach the use of a putty; however, Schmutte further discloses:
Moldable putty (See [61] for two mixable putties that when combined form the final putty to be cured).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to use mixable putties of Schmutte with the prosthetic disclosed by Royer
as Schmutte teaches that the use of the mixable putties allows for molding without the need for specialized tools (See [61]).
Regarding Claim 17, Royer does not teach the use of a putty, however Schmutte further discloses:
wherein the moldable putty material is provided in two parts that are mixed together to form the final moldable putty (See [61] for two mixable putties that when combined form the final putty to be cured).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to use mixable putties of Schmutte with the prosthetic disclosed by Royer
as Schmutte teaches that the use of the mixable putties allows for molding without the need for specialized tools (See [61]).
Regarding Claim 18, Royer does not teach silicone as a material for the moldable element however Schmutte further discloses:
wherein the moldable putty is comprised of a silicone-based material (See [63] for putty to be made of silicone).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to use the silicone putties of Schmutte with the moldable element disclosed by Royer as Schmutte teaches that the use of silicone material allows for quick chemically curing and precise contour (See [29]).
Allowable Subject Matter
Claims 8,9, and 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lukas M Lehman whose telephone number is (571)272-5040. The examiner can normally be reached M-F 7:30-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah C Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.M.L./Patent Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700