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 . Claims 1-14 are pending and examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “26” has been used to designate both recess and circumferential edge. 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.
Specification
The disclosure is objected to because of the following informalities; appropriate correction is required.
Regarding page 11, paragraph 1, “base element 22” should be corrected to “base element 20.”
Regarding page 11, paragraph 2, “forefoot region 2” should be corrected to “forefoot region 21.”
Claim Objections
Regarding claim 1, the recitation “connection device” should be corrected to “proximal connection device.”
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.
Claims 1, 2, 4, 7, 8, and 13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 2005/0038524 A1 (“Jonsson”).
Regarding claim 1, Jonsson discloses a prosthetic foot insert (prosthetic foot 200, see Figs. 8-11), comprising:
a proximal connection device for fastening to a lower leg tube or a lower leg socket (pyramid 37‴ is adapted to connect to a pylon or other prosthesis, see Fig. 8 and [0049]);
at least one base element is coupled or connected to the connection device (foot member 10‴ is connected to pyramid 37‴, see Fig. 8); and
a forefoot region (crepe portion 16‴),
wherein at least one base element has a heel region or is connected to the heel region (foot member 10‴ is connected to heel member 20‴, see Figs. 8 and 9), wherein the heel region is formed from a first material (heel member 20‴ can be fabricated from the same materials as foot member 10‴, which may be made from carbon filament with epoxy binder or other filament types such as glass, Kevlar, and nylon, see [0041] and [0047]) and extends from the forefoot region in a posterior direction (heel member 20‴ extends from the rear end of crepe portion 16‴ in a posterior direction, see Figs. 8 and 9),
wherein the forefoot region is formed from a second material which has a lower modulus of elasticity than the first material (crepe portion 16‴ comprises a resilient pad or cushion made of a compressible or porous material, including solid urethane, which are softer materials than the first range of materials and thus must have a lower modulus of elasticity) and projects forward beyond an anterior end of the heel region (crepe portion 16‴ projects forward past the front end 22‴ of heel member 20‴, see Figs. 8 and 9).
Regarding claim 2, Jonsson further discloses that at least one base element is configured as a guide element, a base spring, or a downwardly inclined forefoot spring (foot member 10‴ is fabricated to be strong while still being able to flex to provide efficient energy storage and release during motion of the foot, where the adapter rolls-up onto the foot member during gait to provide increased flexion and more efficient energy storage and release during heel-strike through toe-off, and therefore foot member 10‴ is configured as a base spring, see [0068], [0070], and [0071]).
Regarding claim 4, Jonsson further discloses that the forefoot region is overmolded, injection-molded, formed by a two-component injection-molding method, or formed by an additive production method on at least one base element, or wherein the forefoot region is materially fastened on at least one base element (crepe portion 16‴ is materially fastened to foot member 10‴ with an adhesive, and can include other means such as bolts, screws, and bands, see [0043]).
Regarding claim 7. Jonsson further discloses that the forefoot region comprises a hallux section (toe member 10a‴), a lateral toe section (toe member 10b‴), and a recess between the hallux section and the lateral toe section (longitudinal slot 16c‴ between toe member 10a‴ and toe member 10b‴, see Fig. 10).
Regarding claim 8, Jonsson further discloses that the forefoot region protrudes medially and/or laterally beyond the first material of the at least one base element (crepe portion 16‴ protrudes laterally beyond the first material of foot member 10‴, see annotated Fig. 10 below).
PNG
media_image1.png
393
786
media_image1.png
Greyscale
Regarding claim 13, Jonsson further discloses that the forefoot region comprises an edge (crepe portion 16‴ can have a rounded edge corresponding to the rounded edge of the front end 12‴, as prosthetic foot 200 having generally the same structure as the prosthetic foot 100, see [0043] and [0061]) and upwardly directed bulges on a lower side (crepe front end 16b‴ bulges upwardly from the tip of crepe portion 16‴ on its lower side, see annotated Fig. 9 below and Fig. 10).
PNG
media_image2.png
457
864
media_image2.png
Greyscale
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0038524 A1 (“Jonsson”) in view of US 2012/0271434 A1 (“Friesen”).
Regarding claim 3, Jonsson does not disclose a reception pocket, however Friesen discloses a similar prosthetic foot with a reception pocket for a spring component (receiving means 42 receives the forefoot spring 2, see Figs. 1 and 2) formed on at least one base element from the first material (receiving means 42 can be formed integrally on the base spring, and thus must be from the first material of the base element, see [0074]).
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 foot disclosed by Jonsson to include a reception pocket that is formed from the same first material as the base element, as taught by Friesen, in order to securely receive and hold the spring component relative to the base element with a form-fit connection.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0038524 A1 (“Jonsson”) in view of US 2014/0058530 A1 (“Cheng”).
Regarding claim 5, Jonsson further discloses that the first material is a polyamide, a thermoplastic copolyester elastomer, or a polyether ether ketone (heel member 20‴ can be fabricated from the same material as foot member 10‴, which includes nylon (polyamide) filament, see [0041]).
Jonsson does not disclose that the second material is a thermoplastic polyamide
elastomer, a thermoplastic copolyester elastomer, a thermoplastic olefin elastomer, a thermoplastic styrene block copolymer, or a urethane-based thermoplastic elastomer, however, Cheng discloses a prosthetic foot where the second material is a thermoplastic elastomer (first curved flexible member 2 can be made of high polymer material including thermoplastic elastomer, see [0028]).
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 second material of the prosthetic foot disclosed by Jonsson to be a thermoplastic elastomer, as taught by Cheng, in order to undergo elastic deformation without being easily broken.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0038524 A1 (“Jonsson”) in view of US 2016/0000582 A1 (“Gunnarssonn”).
Regarding claim 6, Jonsson does not disclose that the first material has a modulus of elasticity greater than the second material, however Gunnarssonn discloses a prosthetic foot with a hybrid layup of different materials, where the first material has a modulus of elasticity greater than the second material by a factor of 2 to 10 (carbon fiber and S-glass materials used in the prosthetic foot had a Young’s modulus of 125 GPa and ~50 GPA respectively, such that the carbon fiber material has a modulus about 2.5 times greater than the S-glass material, see Table. 1). Gunnarssonn teaches that the hybrid layup of different materials is selected to provide increased flexibility or decreased stiffness compared with a carbon-fiber foot member.
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 first and second materials disclosed by Jonsson to have the first material have a modulus greater than the second material by a factor of 2 to 10, because Gunnarssonn teaches that the materials for the prosthetic foot can be selected with different moduli to adjust flexibility, strength, and stiffness. Selecting a modulus ratio of about 2.5 would have been a predictable used of known prosthetic foot properties to enable a stiffer base member with a softer, more flexible forefoot region.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0038524 A1 (“Jonsson”) in view of US 2015/0374514 A1 (“Clausen”).
Regarding claim 9, Jonsson does not disclose a ledge which extends locally or fully over a width of the at least one base element on a lower side, however Clausen discloses a prosthetic foot with a ledge which extends locally or fully over a width of the at least one base element (forefoot piece 410 is generally sized and shaped to correspond to the forefoot region 418 and/or toe region 420 of the foot element 400, see [0042] and Figs. 12A and 12B), wherein the ledge is formed or arranged on a lower side of the at least one base element (forefoot piece 410 is coupled to a bottom surface of at least a portion of the forefoot region 418 and/or toe portion 420 of the foot element 400, see [0042] and Figs. 12A and 12B).
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 foot insert disclosed by Jonsson to include a ledge that extends locally or fully over a width of the lower side of the base element, as taught by Clausen, in order to support the lower foot member during stance at portions of the heel and toe regions, and enhance its suspension and increase vertical displacement due to the fasteners not contacting the ground (see [0043]).
Regarding claim 10, Jonsson does not disclose that the ledge is formed on the at least one base element or by the forefoot region, however Clausen further discloses that the ledge is formed on the at least one base element or by the forefoot region (forefoot piece 410 coupled to bottom surface of at least a portion of the forefoot region 418 and/or toe portion 420 of the foot element 400, see [0042] and Figs. 12A and 12B).
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 foot insert disclosed by Jonsson to include a ledge formed on at least one base element or by the forefoot region, as taught by Clausen, in order to support the lower foot member during stance at portions of the heel and toe regions, and enhance its suspension and increase vertical displacement due to the fasteners not contacting the ground (see [0043]).
Regarding claim 11, Jonsson does not disclose that the ledge has a round or rounded cross section provided with a curvature, however Clausen further discloses the ledge has a round or rounded cross section (bottom surface of the forefoot piece 410 is curved or downward-facing convex, see [0043]) provided with a curvature that decreases in an anterior direction (forefoot piece 410 decreases in curvature in an anterior direction, see Figs. 12A and 12B).
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 foot insert disclosed by Jonsson to have a ledge with a decreasing anterior curvature, as taught by Clausen, in order to support the lower foot member during stance at portions of the heel and toe regions, enable smoother rollovers, and enhance its suspension and increase vertical displacement due to the fasteners not contacting the ground (see [0037] and [0043]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0038524 A1 (“Jonsson”) in view of US 2015/0374514 A1 (“Clausen”), and further in view of US 2013/0144403 A1 (“Lecomte”).
Regarding claim 12, Jonsson does not disclose that the ledge forms a rolling edge, however Clausen further discloses that the ledge forms a rolling edge which bears on ground over a width of the ledge in a terminal stance phase (forefoot piece 410 has downward-facing convex and allows for the foot element 400 to be supported during stance at portions of the heel and toe portion 420, therefore the lower-side convex forefoot piece 410 forms a rolling or contact edge that bears on the ground during stance, see [0043] and Figs. 12A and 12B).
Clausen further teaches that the forefoot and toe features improve rollover and
pressure distribution through the forefoot and big toe region from heel strike to toe off (see [0037]).
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 foot insert disclosed by Jonsson to have
a ledge with a rolling edge, as taught by Clausen, to support the lower foot member during
stance at portions of the heel and toe regions, enable smoother rollovers, improved distribution of pressure, enhanced suspension, and increased vertical displacement.
Jonsson in view of Clausen does not expressly disclose that the ledge forms a rolling edge which bears on ground in a terminal stance phase, however Lecomte discloses a prosthetic foot with a foot member that has a change in curvature (see [0026]). Lecomte teaches that the radius of curvature on the distal side 15b of the segment 15 of downward curvature can be chosen to promote a smooth rollover of the foot member 10 during ambulation, which would occur through terminal stance and toe-off (see [0026]).
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 ledge with a rolling edge which bears on ground as disclosed by Jonsson in view of Clausen to be in a terminal stance phase, as taught by Lecomte, in order to enable smoother rollover during ambulation from heel-strike to toe-off.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over US 2005/0038524 A1 (“Jonsson”) in view of US 6,443,995 B1 (“Townsend”).
Regarding claim 14, Jonsson does not disclose stabilizing struts, however Townsend discloses a prosthetic foot including stabilizing struts formed in the forefoot region (expansion joint struts 38, 39 and 40 included in forefoot portion 2A, see col. 12, lines 20-33 and Figs. 3 and 4). Townsend teaches that as the plantar weight-bearing surface contacts the ground, weight is borne on the expansion joint struts creating a suspended web effect, thereby maintaining structural stability for a stable foot while improving biplanar forefoot motion capabilities (see col. 12, lines 20-33).
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 foot insert disclosed by Jonsson to include stabilizing struts in the forefoot region, as taught by Townsend, in order to improve stability, forefoot flexibility during gait, and load distribution.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHA UYEN C NGUYEN whose telephone number is (571)272-3399. The examiner can normally be reached Monday-Friday 8:30-5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.C.N./Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
Prosecution Insights