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 .
Response to Amendment
The amendment filed 1/29/2026 has been received and made of record. Claims 1-20 are currently pending, of which claims 1-13 and 18-20 are being examined.
Response to Arguments
Applicant's arguments filed 1/29/2026 have been fully considered but they are persuasive. In response to the applicant’s arguments regarding the newly added claim limitation and the previously made rejection, attention is directed to the new prior art of record Einarsson et al (US 6,592,539 B1) as applied to the claims in the below rejection.
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 1-2, 4, 7, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan et al (US 2008/0154164 A1) in view of Einarsson et al (US 6,592,539 B1).
Regarding claim 1, Sheehan discloses an orthopaedic device, comprising - a support plate (splint member 201), - a piece of fabric (13; spacer 13 can be fabric [0116], [0174], [0295], [0330]), wherein - the support plate is malleable into an orthopaedically supporting shape ([0330], [0343]) the support plate having a supporting surface to be arranged towards an object to be supported (inner surface Figure 4) and an opposite distal surface (outer surface Figure 4), wherein -the supporting surface of the support plate is adhered to a receiving zone of the piece of fabric (Figures 2-3, 18; [0200], such that - the distal surface of the support plate constitutes a part of a distal surface of the device (Figures 2-4, 18), and - the piece of fabric is larger than the support plate (Figures 3-4, 18), providing thus an attachment zone for fastening the orthopaedic device (via exposed portion of 13; Figure 4 or 18). Sheehan does not disclose the fabric comprises a guiding marking that indicates a position to place the support plate on the piece of fabric. Einarsson teaches an orthotic comprising a fabric (20) comprising a guiding marking (34, 36) that indicates a position to place a support plate (32) on the piece of fabric (Figures 2-5; Col. 4, lines 5-14). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the fabric of Sheehan having the guide markings as taught by Einarsson to assist in fabrication (Col. 4, lines 5-14).
Regarding claim 2, Sheehan discloses wherein the support plate is made of a composition comprising -thermoplastic polymer and -wood particles in form of granules, plates and/or fibers ([0049]).
Regarding claim 4, Sheehan discloses wherein the thermoplastic polymer is biodegradable polymer ([0150], [0192]).
Regarding claim 7, Sheehan discloses wherein the support plate may comprise at least one opening (203, Figure 4).
Regarding claim 12, Sheehan discloses an exposing element arranged for exposing a premature removal of the orthopaedic device, wherein the exposing element comprises an indication marking that breaks or changes an appearance of the indication marking when the orthopaedic device is removed from the object ([0347] discloses tape, Figure 18; applicant discloses tape is a suitable indication marking on page 16).
Claims 1, 8-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 4,066,074) in view of Einarsson et al (US 6,592,539 B1).
Regarding claim 1, Keller discloses an orthopaedic device, comprising - a support plate (10), - a piece of fabric (11; Col. 2, lines 6-8 and 19-25), wherein - the support plate is malleable into an orthopaedically supporting shape (Col. 2, lines 36-65), the support plate having a supporting surface (bottom surface in Figure 2) to be arranged towards an object to be supported (the device is capable of being applied such that the bottom surface of 10 in Figure 2 is capable of being applied to the object being supported) and an opposite distal surface (top surface of 10 in Figure 2), wherein -the supporting surface of the support plate is adhered (via adhesive 12) to a receiving zone of the piece of fabric (11 at adhesive 12; Figure 2), such that - the distal surface (top surface in Figure 2) of the support plate constitutes a part of the distal surface of the device (Figure 2), and -the piece of fabric (11) is larger than the support plate (10), providing thus an attachment zone for fastening the orthopaedic device (Figures 2 and 4). Keller does not disclose the fabric comprises a guiding marking that indicates a position to place the support plate on the piece of fabric. Einarsson teaches an orthotic comprising a fabric (20) comprising a guiding marking (34, 36) that indicates a position to place a support plate (32) on the piece of fabric (Figures 2-5; Col. 4, lines 5-14). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the fabric of Keller having the guide markings as taught by Einarsson to assist in fabrication (Col. 4, lines 5-14).
Regarding claim 8, Keller discloses wherein the piece of fabric is made of material comprising thermoplastics (Col. 2, lines 7-8 and 26-29).
Regarding claim 9, Keller discloses wherein the piece of fabric has a self-attaching surface structure having ability to fasten with itself as such (Col. 2, lines 6-13 and 20-29).
Regarding claim 10, Keller discloses wherein - the self-attaching surface structure of the piece of fabric comprises a fiber loop bundle fabric and hook-and-loop fastener (Col. 2, lines 6-13).
Regarding claim 11, Keller discloses wherein the piece of fabric has ability to fasten with itself in a normal temperature (Col. 2, lines 6-13 and 20-29).
Regarding claim 13, Keller discloses a further material layer (12) fastened to the receiving zone of the piece of fabric on the same side thereof in relation to the support plate (Figure 2).
Claims 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Sheehan et al (US 2008/0154164 A1) in view of Einarsson et al (US 6,592,539 B1) in view of Parssinen (US 2012/0071590 A1).
Regarding claim 3, Sheehan and Einarsson teach that as applied above. Sheehan discloses wherein the biodegradable polymer comprises polycaprolactone and wood fibers or sawdust ([0150]) but does not disclose the thermoplastic is non-biodegradable. Parssinen teaches a composite material for casting and splinting ([0002]) comprising caprolactone homopolymer ([0021], [0074]) reinforced with platy wood particles ([0055], [0057]) and teaches that non-biodegradable thermoplastic materials can be used as an alternative to biodegradable ones ([0087]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Sheehan and Einarsson wherein the thermoplastic is non-biodegradable as taught by Parssinen as being an alternative to biodegradable thermoplastics to increase longevity of the device in situations where environmental safety is not a priority. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 5, Sheehan and Einarsson teach that as applied above. Sheehan discloses that as applied above wherein the biodegradable polymer comprises polycaprolactone and wood fibers or sawdust ([0150]) but does not specify caprolactone homopolymers and platy wood particles. Parssinen teaches a composite material for casting and splinting ([0002]) comprising caprolactone homopolymer ([0021], [0074]) reinforced with platy wood particles ([0055], [0057]). Parssinen teaches providing the platy wood particles as opposed to smaller powdered particles orientate in the polymer matrix to provide self-reinforcement and stability ([0020], [[0067]). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the splint of Sheehan and Einarsson comprising caprolactone homopolymers and platy wood particles as taught by Parssinen to provide self-reinforcement and stability. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 4,066,074) in view of Einarsson et al (US 6,592,539 B1) in view of Arluck (US 4,136,686).
Regarding claim 6, Keller and Einarsson disclose that as applied above but does not disclose the support plate is made of a metal or alloy. Arluck teaches an orthopedic device wherein the support comprises a metal as an alternative to plastic (Col. 6, lines 47-55; Col. 11, lines 18-28). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the support plate of Keller made of metal as taught by Arluck to provide a protective reinforcing layer. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 4,066,074) in view of Einarsson et al (US 6,592,539 B1) in view of Iglesias et al (US 2005/0165338 A1).
Regarding claim 18, Keller and Einarsson disclose that as applied above but does not disclose the support plate is made of aluminum. Iglesias teaches an orthopedic device wherein the support comprises aluminum ([0099],[0104])). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the support plate of Keller made of aluminum as taught by Iglesias to provide a protective reinforcing layer. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 19 is rejected under 35 U.S.C. 103 as being unpatentable over Keller (US 4,066,074) in view of Einarsson et al (US 6,592,539 B1) in view of Edenbaum et al (US 5,520,621).
Regarding claim 19, Keller and Einarsson teach that as applied above but do not teach a further material layer of fabric. Edenbaum teaches a splint having an additional material layer that comprises fabric (36; Col. 5, lines 46-64). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Keller and Einarsson having a further layer of fabric as taught by Edenbaum to provide additional protection.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Sheehan et al (US 2008/0154164 A1) in view of Einarsson et al (US 6,592,539 B1) in view of Joseph (US 8,951,217 B2).
Regarding claim 20, Sheehan and Einarsson teach that as applied above but does not disclose wherein the piece of fabric comprises at least one active additive for promoting healing of a wound on the object. Joseph teaches an orthopedic device wherein the inner layer comprises at least one active additive for promoting healing of a wound on the object (Col. 8, lines 1-8). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Sheehan and Einarsson having an additive for promoting would healing as taught by Joseph to provide therapeutic aid to the skin.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KARI K RODRIQUEZ/ Primary Patent Examiner, Art Unit 3786
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