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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-8 and 14-20, Figs. 1-5 and newly added claims 31-35 in the reply filed on 05/06/2026 is acknowledged. Claims 9-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-8, 14-20 and 31-35 are presently pending in this application.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “108” has been used to designate both “actuator” and “outer sidewall”. 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. 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 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.
Claims 1-8, 14-20 and 31-35 are rejected under 35 U.S.C. 103 as being unpatentable over Mahon (2011/0071647) in view of Coppens et al. (2008/0269914) “Coppens”.
Regarding claims 1, 14 and 31, Mahon discloses an adjustable prosthetic socket 100 (Fig. 1 and abstract), comprising: a socket 110 (Fig. 1) comprising a proximal open end 124, a distal end that is substantially closed (end having attachment 126; Fig. 1), and a wall 120 surrounding and extending from the distal end to the proximal open end (Fig. 1); the socket configured to at least partially surround and secure a residual limb (par. 0060); at least one recess in the wall of the socket, wherein the at least one recess has no opening or cutouts (Fig. 3 and par. 0066 disclose a pad 154 placed within the receptacle 120 inside cavity 140 where the pad can be moved outwardly to bring an inner surface of the pad into alignment with an inner surface of the receptacle 120 creating a recess comprising the walls of the receptacle 120 and panel 122f);
at least one adjustable panel 154 sized to be arranged in the at least one recess (when the pad 154 moves outwardly and aligns with the inner surface of the receptacle 120, the pad 154 is arranged in the recess formed by the walls of the receptacle 120 and panel 122f) , wherein the at least one adjustable panel 154 resides entirely inside the socket and does not extend outside of the heat moldable socket (par. 0066 discloses the pad 154 aligns the inner surface and is located inside of receptacle 120 in its outward most position) and
an actuator 170 (Fig. 2 and par. 0073) coupled to a cable or wire and a tensioning line 104 that is configured to change an inner circumference of the socket by operation of the actuator applying tensions to the cable or wire and moving the at least one adjustable panel from a first position to a second position (par. 0073 discloses the actuator 170 can selectively apply tension to tensioning line 104 with tightening member 108 configured to move panels 122 and pad 154 inwardly; pars. 0074 0066), wherein the second position reduces at least a portion of the inner circumference of the socket (par. 0074 discloses the inward movement of pad 154 and panels 122 caused by the tension line 104 constricts a perimeter of the socket).
Mahon is silent regarding a heat moldable socket. However, Coppens teaches a similar prosthetic socket 10 comprising a heat moldable socket (par. 0025 and abstract). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prosthetic socket in Mahon to include a heat moldable socket, as taught and suggested by Coppens, for providing a custom fitted socket that maximizes patient comfort (par. 0002).
Regarding claim 2, Mahon discloses wherein the actuator 170 (Fig. 2) is configured to apply tension to the cable or wire (par. 0073).
Regarding claims 3, 18, 19 and 34, Mahon discloses further comprising a flexible inner socket or liner 144 (Fig. 3) configured to be arranged in a portion of the socket 110 (par 0061 discloses textile layer 144 inside receptacle 120 of socket 110) and Coppens teaches the heat moldable socket 10 (Fig. 1).
Regarding claims 4-7, 15-17, 32 and 33, Mahon in view of Coppens discloses the claimed invention of claim 1; except for wherein the heat moldable socket comprises an injection molded premade thermoplastic elastomer socket comprising a thermoformable material; wherein the injection molded premade thermoplastic elastomer socket is configured to be heated to a shaping temperature and becomes formable and stretchable; wherein the at least one adjustable panel comprises one of a thermoplastic plastic and polymeric material; wherein the at least one adjustable panel is configured to be heated to a formable temperature so that the at least one adjustable panel can be molded into a predetermined geometric configuration; wherein the panel comprises one of a thermoplastic plastic material and a polymeric material; wherein the heat moldable socket has a shaping temperature in a range of about 120 °F to about 305 °F and any sub-range thereof; wherein the panel is heat moldable.
However, Coppens teaches a similar prosthetic socket comprising an injection molded premade thermoplastic elastomer socket comprising a thermoformable material (par. 0005 discloses thermoplastic material and par. 0024 discloses injection molding); wherein the injection molded premade thermoplastic elastomer socket is configured to be heated to a shaping temperature and becomes formable and stretchable (par. 0029); wherein the at least one adjustable panel comprises one of a thermoplastic plastic and polymeric material (the combination of the panel 154 and the thermoplastic materials of Coppens at par. 0024 arrive at the panel comprising thermoplastic material); wherein the at least one adjustable panel is configured to be heated to a formable temperature so that the at least one adjustable panel can be molded into a predetermined geometric configuration (combination of Mahon and Coppens); wherein the panel comprises one of a thermoplastic plastic material and a polymeric material (combination of Mahon and Coppens); wherein the heat moldable socket has a shaping temperature in a range of about 120 °F to about 305 °F and any sub-range thereof; wherein the panel is heat moldable (par. 0009 of Coppens). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prosthetic socket in Mahon to include a heat moldable socket comprising an injection molded premade thermoplastic elastomer socket comprising a thermoformable material; wherein the injection molded premade thermoplastic elastomer socket is configured to be heated to a shaping temperature and becomes formable and stretchable; wherein the at least one adjustable panel comprises one of a thermoplastic plastic and polymeric material; wherein the at least one adjustable panel is configured to be heated to a formable temperature so that the at least one adjustable panel can be molded into a predetermined geometric configuration; wherein the panel comprises one of a thermoplastic plastic material and a polymeric material; wherein the heat moldable socket has a shaping temperature in a range of about 120 °F to about 305 °F and any sub-range thereof; wherein the panel is heat moldable, as taught and suggested by Coppens, for providing a reformable custom fitted socket that maximizes patient comfort (pars. 0002 and 0009).
Furthermore, the claimed phrase “injection molded” in claims 4 and 5 is being treated as a product-by-process limitation and a product-by-process claim is not limited to the manipulations of the recited steps, only the structure implied by the steps. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Regarding claim 8, Mahon discloses wherein the actuator cannot rotate more than one of 360 degrees, 180 degrees, and 90 degrees (par. 0086 discloses max rotation of 30 degrees).
Regarding claims 20 and 35, Mahon discloses wherein the at least one adjustable panel comprises a plurality of alignment features (guides 106/107; Fig. 2 and par. 0070).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah 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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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774
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