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 Arguments
Applicant's arguments filed 01/20/26 have been fully considered but they are not persuasive.
On page 9 regarding claim objections and drawing objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully withdraws the objections which were addressed.
On pages 9-10 Applicant argues [0085] states that the wear-resistant and high-friction sole surface is a “solid material without voids or lattice structure”, and have durability.
The Examiner respectfully withdraws the 112 rejection of record, with the understanding that any “solid material” “without voids or lattice structure” constitutes a wear-resistant and high-friction material.
On pages 11-12 regarding prior art rejections, Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first portion of the footshell, the second portion of the footshell, the sole portion, the distalmost surface of the prosthetic foot, arch section, the distal surface of the prosthetic foot must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
The drawings are objected to because:
-item “120” refers to two different structures in figure 1.
-item “1102” is in the specification but not the figures.
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 17 is objected to because of the following informalities:
Claim 17 is objected to for not further limiting the subject matter of claim 11.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 11-13, 16-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubie et al. (US 20210177628 A1) hereinafter known as Rubie in view of Friesen et al. (US 20170135828 A1) hereinafter known as Friesen.
Regarding claims 11 and 17 Rubie discloses a prosthetic device comprising:
a foot shell (Abstract “foot cover”) comprising:
a first portion having a polymer lattice structure (Figure 5 item 106; [0028] lattice framework of an elastic polymer), and a second portion(Figure 5 item 502),
wherein the second portion is a sole portion (Figure 5) located below a distalmost surface of a prosthetic foot (see for example, Figure 1 which shows the distalmost surface of a foot 104 located above the sole portion of the shell),
and wherein the first and second portions have a continuous, single-piece construction ([0074] the prosthetic foot cover, lattice, negative pressure pump, and heel dampener can be within a monolithic device created using a single additive manufacturing or printing process),
but is silent with regards to the second portion being a solid material without voids or lattices.
However, regarding claims 11 and 17 Friesen teaches that soles of a prosthetic foot cover can include a solid material portion as a sole portion below a distalmost surface of a prosthetic foot, the solid material portion having no voids or lattices (Figure 1 item 43; [0010], [0014], [0034], [0038] the casing 4 which forms a distal end 42 can be made of a foam material. (Applicant’s specification [0062] distinguishes a “solid part” from a “lattice”. The specification [0083] describes figure 10 item 1050 as illustrating “voids”, which are incorporated into the manufacturing method to reduce weight. They are seen and described as being cutouts with large dimensions visible to the naked eye. Paragraph [0094] indicates that a solid/foam material are related to one another, as being distinct from the “lattice structures disclosed herein”. Accordingly, foam structures are not understood to include voids based on Applicant’s specification.)). Rubie and Friesen are involved in the same field of endeavor, namely prosthetic foot covers. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Rubie so that the second portion is made of a material without voids or lattices as is taught by Friesen since it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. In this case, any material which is used for a distalmost surface of a sole portion of a prosthetic foot shell would have been obvious to try. Additionally, Friesen [0008]-[0009]) indicates this particular construction is desirable in order to ensure the foot encourages the desired roll-over behavior during use.
Regarding claim 12 the Rubie Friesen Combination teaches the device of claim 11 substantially as is claimed,
wherein Rubie further discloses the sole comprises a wear-resistant, high-friction sole surface ([0028] an elastic polymer is understood to be wear-resistant and high-friction).
Regarding claim 13 the Rubie Friesen Combination teaches the device of claim 12 substantially as is claimed,
wherein Rubie further discloses the sole surface is additively manufactured with the first portion (The applicant is advised that this is a product-by-process claim. 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. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”. See MPEP 2113. In this case, the cited limitations failed to distinguish the claimed structure from Rubie, since all the structural limitations of the claim appear to be met. [0028]-[0029] the cover is made via additive manufacturing).
Regarding claim 16 the Rubie Friesen Combination teaches the device of claim 11 substantially as is claimed,
wherein Rubie further discloses the first portion has a first density (Figure 5 item 106) and the second portion has a second density different than the first density (Figure 5 item 502; see also [0011], [0044]).
Also, see the rejection to claim 1 above, the density of Rubie item 106 and Friesen item 43 is different since their constructions differ, along with Friesen [0011] describing how the material throughout the foot should exhibit different densities.
Regarding claim 18 Rubie discloses the device of claim 11 substantially as is claimed,
wherein Rubie further discloses the first portion has a first stiffness and the second portion has a second stiffness different from the first stiffness (see Figure 5, [0044], and [0028] the lattice is made of a (single) elastic polymer, meaning that the difference in densities will contribute to the two stiffnesses being different with the sole giving more support and strength (stiffness) via its lesser density).
Also, see the rejection to claim 1 above, the stiffness of Rubie item 106 and Friesen item 43 is different since their constructions differ, along with Friesen’s Abstract and [0009] describing how the material throughout the foot should exhibit different stiffnesses in order to create a desired rollover effect.
Regarding claim 20 the Rubie Friesen Combination teaches the device of claim 15 substantially as is claimed,
wherein Rubie further teaches the sole portion covers at least 30% of the distalmost surface of the foot (the Examiner notes that while the figures of Rubie are not understood to be drawn to scale, they are also not understood to be completely inaccurate. Figure 5 (in combination with Figure 1 which shows the foot placement) shows the sole portion item 502 to be spanning about half the length of the foot sole. Accordingly, the person of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of Rubie so that the sole portion covers at least 30% of the distalmost surface of the foot as is shown by Rubie).
Claims 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubie and Friesen as is applied above in view of Moretti et al. (ES 2979162 T3), hereinafter known as Moretti.
Regarding claim 15 the Rubie Friesen Combination teaches the device of claim 11 substantially as is claimed,
but is silent with regards to the specific density of the sole portion.
However, regarding claim 15 Moretti teaches that a footwear sole can have a density greater than 1.0 g/cc (page 8, second to last paragraph of the translation “density between approximately 0.9 and 1.3 g/cm3)). Rubie and Moretti are involved in the same field of endeavor, namely soles of footwear. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Rubie Friesen Combination so that the sole portion’s density was greater than 1.0 g/cc as is taught by Moretti since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only ordinary skill in the art. See MPEP 2144.05(II)(A).
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rubie and Friesen as is applied above, further in view of Thorhallsdottir et al. (US 8128709 B2) hereinafter known as Thorhallsdottir.
Regarding claim 19 the Rubie Friesen Combination teaches the device of claim 11 substantially as is claimed,
but is silent with regards to the first portion being fabricated from a material with a different chemical composition than the second portion.
However, regarding claim 19 Thorhallsdottir teaches that sole portions of prosthetic covers can be manufactured using a material with a different chemical composition than that which a first portion is made from (Column 3 lines 20-22 the foot cover is made of polyurethane; Column 4 lines 22-25 or Column 5 lines 14-16 EVA or highly elastic urethane can be used as a sole material). Rubie and Thorhallsdottir are involved in the same field of endeavor, namely prosthetic foot covers. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of the Rubie Friesen Combination to have the two portions made of different chemical compositions as is taught by Thorhallsdottir since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the person of ordinary skill would find it obvious to try any methods of changing the density/support/strength of the sole regions (since Rubie [0044] teaches this is desirable), and/or to provide the shock absorption benefits within the sole of the foot of Rubie.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 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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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 02/10/26