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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/24/2025 has been entered.
Response to Amendment
Applicant’s amendments of claims 1, 3-9, 12-13, 15-17, and 24-29 are acknowledged by the Examiner.
Applicant’s amendments of claims 1, 4-9, 12-13, 15-17, 24, and 27-29 have overcome a majority of the claim objections. Therefore, the claim objections are withdrawn. Claim 12 still recites “the footplate” and remains objected to.
Applicant’s amendments of claims 3, and 12 have overcome some of the claim rejections under 35 U.S.C. 112(b). The rejections under 35 U.S.C. 112(b) are updated below.
Currently claims 1-17, and 24-29 are pending in the current application.
Response to Arguments
Applicant's arguments filed 07/24/2025 have been fully considered but they are not persuasive.
In regards to Applicant’s arguments that Nobbe in view of Zachariasen fails to disclose the newly amended limitations of the pre-fabricated, single-piece strut including a distal end having a pair of fingers each having a hole and the additively manufactured footplate including holes that align with the holes in the fingers. Examiner notes that Lasher teaches these features. As can be seen in figure 2 of Lasher, each of the fingers (5) as taught by Lasher include a hole (see figure 2 that 5a extends through 5, and thus, suggests a hole through 5) for receiving attachment structures (5a) to attach the fingers (5) to the foot device (3), thus making obvious the inclusion of holes in the fingers for the purpose of receiving attachment structures which attach the fingers to the foot device. Furthermore, as can also be seen in figure 2 of Lasher the attachment structures (5a) similarly extend into the foot device (3) which also suggests a hole through the foot device (3) aligned with the holes through the fingers (5) to receive the attachment structures (5a), thus making obvious the inclusions of holes in the additively manufactured foot plate also for the purpose of receiving attachment structures which attach the fingers to the foot device. Therefore, while neither reference of Nobbe or Zachariasen discloses the newly amended limitations, the teaching reference of Lasher teaches the newly amended limitations as discussed above. Therefore, the combination of Nobbe in view of Zachariasen and Lasher discloses the newly amended claim limitations.
In regards to Applicant’s arguments that the combination of Nobbe in view of Lasher to include the features of “the pre-fabricated, single-piece strut including a distal end having a pair of fingers each having a hole and the additively manufactured footplate including holes that align with the holes in the fingers” would require a redesign of the device of Nobbe, as such features would prevent the wedge(s) 20 from being disposed between part 30 and the strut 12 when such portions are coupled together. Examiner respectfully disagrees.
Examiner first suggests that one of ordinary skill in the art could simply rearrange wedge 20 to be positioned between 30 and 14 of Nobbe, which would result in wedge 20 still providing the desired effect of adjusting the DROCS for angle and tilt required for each patient as disclosed by [0021] of Nobbe. Furthermore, Examiner also notes that Nobbe discloses in [abstract], and [0005] that: (m)ounting structure may also include mounting plates positioned on the rear surface of the strut and one or more tapered wedges. Thus, suggesting that not only are the wedge plates optional, but also that there are embodiments where only a single wedge (i.e. only the wedge located at the proximal end of 12) may be used depending on the user.
Further, Nobbe also discloses in [0021] that “Wedge shaped plates 20 or discs 62 can be utilized between the strut 12 and each of the attached components”. Further evidencing that wedges 20 are optional inclusions which “can be utilized”.
Furthermore, Nobbe also discloses in [0028] that “Fitting and alignment are adapted for each end user… adjustments are made for the end user. These adjustments may include angulation changes and rotary position changes…These are accomplished by placement and orientation of the wedge plates”. Which also suggests that the device may or may not be adjusted depending on the user, and thus may not include wedges to provide the optional angulation changes and rotary position changes.
Thus, the modification of Nobbe in view of Zachariasen and Lasher does not destroy the operation, or require a redesign of the device of Nobbe as suggested by Applicant for the aforementioned reasons.
With regards to Applicant’s arguments that Lasher does not disclose a footplate. Examiner agrees that Lasher discloses a shoe and not a footplate. However, Lasher does not need to disclose a footplate as this feature is already disclosed by Nobbe. Lasher as discussed above, discloses attachment of the fingers (5) of the single-piece strut (4) through use of aligning holes in the fingers (5) and holes the structure intended to be worn on a user’s foot (3) for the purpose of receiving attachment structures (5a) which make obvious a modification of the strut, and foot plate disclosed by Nobbe as will be discussed below.
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 second hole, and the third hole (of the center portion of the anchor) each aligning the holes in the fingers of claim 12 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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
Claims 1, 4 and 12 is objected to because of the following informalities:
Claim 1 recites the limitation “each aligning with holes in the fingers”. This limitation should be amended to recite “the holes in the fingers”.
Claim 4 recites the limitation “on the finger” in line 3. This limitation should be amended to recite “the pair of fingers” to maintain consistency in the claims.
Claim 12 recites the limitation “the footplate” in line 7. This limitation should be amended to recite “the additively manufactured footplate” to maintain consistency in the claims.
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 3-4, 8, and 12-16 are 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 3 recites the limitation " the center portion" in line 2. There is insufficient antecedent basis for this limitations in the claim. For the purpose of examination, Examiner will interpret this limitation as “a center portion”.
Claim 4 recites the limitation "the anchor" in line 2. There is insufficient antecedent basis for this limitations in the claim. For the purpose of examination, Examiner will interpret this limitation as “an anchor”.
Claim 4 recites the limitation "the hole in the center portion" in line 2. There is insufficient antecedent basis for this limitations in the claim. For the purpose of examination, Examiner will interpret this limitation as “a hole in the center portion”.
Claim 8 recites the limitation "the anchor" in the line 5. There is insufficient antecedent basis for this limitations in the claim. For the purpose of examination, Examiner will interpret this limitation as “an anchor”.
Claim 12 recites the limitation “an anchor with two fingers forming a two-finger expansion and coupled to the footplate, the anchor having a center portion with a hole, a second hole, and a third hole, and each finger including a hole, the second and third holes each aligning the holes in the fingers”. This limitation is held to be unclear in view of the drawings given the center portion of the anchor, while seen to have four holes in embodiments seen in figure 15 is not seen to have any holes that align the holes of the fingers. Therefore, claim 12 is considered unclear as to what is being claimed. For the purpose of examination, Examiner will interpret this limitation of claim 12 as: “the anchor having a center portion with a hole,
Claim 16 recites the limitation “the hole in the center portion of the anchor” this limitation is held to be unclear in view of claim 12 which currently recites “the anchor having a center portion with a hole, a second hole, and a third hole”. Therefore, it is unclear as to which hole of the center portion of the anchor applicant is referring to. For the purpose of examination, Examiner will interpret claim 16 in view of the interpretation of claim 12 described above which recites only a single hole for the center portion of the anchor.
Claims 12-15 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 27 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 27 recites the limitation “wherein the stiffness of the pre-fabricated, single-piece strut is suited to one or more gait needs or requirements of the patient”. This limitation is recited verbatim in claim 24 from which claim 27 depends. Therefore, claim 27 is of improper dependent form for failing to further limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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(s) 1-6, 12-15, and 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nobbe et al. (US 2007/0027421 A1) (hereinafter Nobbe) in view of Zachariasen (US 2014/0180185 A1) and Lasher (US 1,332,047).
In regards to claim 1, Nobbe discloses an ankle-foot orthosis (10; see [0019]; see figure 1) comprising:
a manufactured footplate (14; see [0021]; see figure 1);
a calf cuff (16; see [0021]; see figure 1) separate from the manufactured footplate (14); and
a pre-fabricated strut,(12, 30, and left and right 38 taken together; see [0021], and [0032-0033]; see figure 3; 12, 30, and left and right 38 are pre-fabricated prior to utilization in 10, and are assembled together and thus are considered as “the pre-fabricated strut”; hereinafter solely referred to as 12) connecting the manufactured footplate (14) to the calf cuff (16), the pre-fabricated strut (12) having a thickness and a width (see figure 1) adapted to define a patient-specific stiffness about an ankle joint of a patient (see [0021] in reference to sizing and shaping each structure to match the limb of the individual) the pre-fabricated strut (12) including a distal end (end comprising 30 and 38) having a pair of fingers (left and right 38) coupled to the additively manufactured footplate (14; see figure 3).
Nobbe does not disclose the manufactured foot plate is an additively manufactured footplate produced by “additive manufacturing”. However, this limitation is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Nonetheless, Zachariasen teaches an analogous footplate (footplate as seen in figure 9) which is produced by additive manufacturing (see [0016] in reference to producing the orthosis by additive manufacturing) for the purpose of eliminating the labor-intensive processes of hand-forming a positive model and making the orthosis, thereby significantly reducing the amount of time it takes to make a custom orthosis (see [0051]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manufactured footplate as disclosed by Nobbe and to have formed the manufactured footplate by the additive manufacturing process as taught by Zachariasen in order to have provided an improved method of producing the manufactured footplate that would add the benefit of eliminating the labor-intensive processes of hand-forming a positive model and making the orthosis, thereby significantly reducing the amount of time it takes to make a custom orthosis (see [0051]).
Nobbe as now modified by Zachariasen does not disclose the pre-fabricated strut is a pre-fabricated, single-piece strut, and
each finger having a hole, and the additively manufactured footplate including holes each aligning with holes in the fingers.
However, Lasher teaches an analogous ankle foot orthosis (brace; see [page 1 ln 55-70]; see figure 1) comprising an analogous portion to be worn on a user’s foot (2; see [pg 1 ln 65-75]; 2 while being a shoe, is a portion of the ankle foot orthosis to be worn on the user’s foot, and therefore is considered analogous to the manufactured footplate of Nobbe) and an analogous pre-fabricated strut (4; see [Page 1 ln 75-80]; see figure 1; 4 is pre-fabricated prior to the assembly of the orthosis) comprising a distal end (forked end; see figures 1 and 2) having a pair of fingers (left and right 5; see [pg 1 ln 100-108]; see figures 1 and 2); the pre-fabricated strut (4) is a pre-fabricated, single-piece strut (see figure 2 that 4 and 5 are formed as a single-piece strut), and
each finger (left and right 5) having a hole (see figure 2 that left and right 5 each have a hole for receiving 5a), and the portion to be worn on the user’s foot (2) including holes (see figure 2 that left and right sides of 3 each have a hole for receiving 5a) each aligning with holes in the fingers (left and right 5; see figure 2 that the holes formed through left and right 5, and into left and right sides of 3 align with one another for receiving 5a) for the purpose of attaching the strut to the portion to be worn on a user’s foot to provide a firm means of support to the user’s ankle (see [pg 2 ln 1-11]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-fabricated strut, the fingers of the pre-fabricated strut, and the additively manufactured footplate as disclosed by Nobbe as now modified by Zachariasen and to formed the pre-fabricated strut as a single piece (thereby forming a pre-fabricated, single-piece strut), and to have included the holes in each of the fingers and additively manufactured footplate which align with each other and receive an attachment mechanism as taught by Lasher in order to have provided an improved pre-fabricated strut that would add the benefit of increasing the ease of manufacturing as the pre-fabricated strut would be produced simultaneously in one step, and the benefit of attaching the strut to the additively manufactured foot plate to provide a firm means of support to the user’s ankle (see [pg 2 ln 1-11]).
In regards to claim 2, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe as now modified by Zachariasen Lasher does not disclose wherein the calf-cuff is additively manufactured, and a separation of the additively manufactured footplate and the additively manufactured calf cuff allows an additive manufacturing time of the ankle-foot orthosis to be reduced. However, these limitations are drawn to an article of manufacture, and therefore the limitations are considered to be product-by-process limitations that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Nonetheless, Zachariasen teaches an analogous calf cuff (calf cuff as seen in figure 9) which is produced by additive manufacturing (see [0016] in reference to producing the orthosis by additive manufacturing) for the purpose of eliminating the labor-intensive processes of hand-forming a positive model and making the orthosis, thereby significantly reducing the amount of time it takes to make a custom orthosis (see [0051]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calf cuff as disclosed by Nobbe and to have formed the calf cuff by additive manufacturing as taught by Zachariasen in order to have provided an improved method of producing the calf cuff that would add the benefit of eliminating the labor-intensive processes of hand-forming a positive model and making the orthosis, thereby significantly reducing the amount of time it takes to make a custom orthosis (see [0051]). Thus, forming the foot plate and calf cuff separately which would allow an additive manufacturing time of the ankle-foot orthosis to be reduced as claimed.
In regards to claim 3, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses each finger (left and right 38) extending from the center portion (30; see figure 5) the pair of fingers (left and right 38) adapted to extend around an ankle region of the patient (see figure 3).
In regards to claim 4, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe as now modified by Lasher further discloses wherein the pair of fingers (left and right 38 of Nobbe) outwardly and downwardly extend from the center portion (30 of Nobbe) of the anchor (30 and 38 of Nobbe; see figures 3 and 5 of Nobbe), positioning the hole (32 of Nobbe; see [0028] and figure 3 of Nobbe) in the center portion (30 of Nobbe; see figure 3 of Nobbe) above each hole (holes in left and right 38 of Nobbe as taught by Lasher) disposed on the finger (left and right 38 of Nobbe), forming a three-hole configuration on the distal end (end of 12 comprising 30 and 38 of Nobbe) of the pre-fabricated, single-piece strut (12 of Nobbe as now modified by Lasher; see figure 5 of Nobbe that left and right 38 are positioned below 30, thus the holes taught by Lasher included into left and right 38 of Nobbe, would be positioned below the hole in the center portion and form a three-hole configuration as claimed).
In regards to claim 5, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses the pre-fabricated, single-piece strut (12 of Nobbe as now modified by Lasher) including one or more of a proximal end (upper end of 12; see figure 3) adapted to be coupled to the calf cuff (16; see figure 3 that the upper end of 12 couples to 16), the proximal end (upper end of 12) having two holes (28; see [0028]; see figure 3), or a cross-section having a C-, V- r I-shape (12 being a flat bar has a cross section in the shape of an I, similar to Applicant’s flat bar having the same cross section).
In regards to claim 6, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses wherein the two holes (28) of the proximal end (upper end of 12) of the pre-fabricated, single-piece strut (12 of Nobbe as now modified by Lasher) are disposed in a vertical orientation (see figure 3).
In regards to claim 12, Nobbe discloses (see rejection of claim 12 under 35 U.S.C. 112(b) and resulting interpretation of claim 12 above, said interpretation being included into the body of the rejection below for clarity purposes) an ankle-foot orthosis (10; see [0019]; see figure 1) comprising:
a manufactured footplate (14; see [0021]; see figure 1);
a calf cuff (16; see [0021]; see figure 1) separate from the manufactured footplate (14); and
a pre-fabricated strut, (12, 30, and left and right 38 taken together; see [0021], and [0032-0033]; see figure 3; 12, 30, and left and right 38 are pre-fabricated prior to utilization in 10, and are assembled together and thus are considered as “the pre-fabricated strut”; hereinafter solely referred to as 12) connecting the manufactured footplate (14) to the calf cuff (16),
wherein the pre-fabricated strut (12) includes a distal end (end comprising 30 and 38) having an anchor (30 and 38; see [0032-0033]; see figure 3) with two fingers (left and right 38; see figure 5) forming a two finger expansion (see figure 5) and coupled to the manufactured footplate (14; see figure 2), the anchor (30 and 38) having a center portion (30) with a hole (32 located in 30; see [0028]; see figure 3), wherein the manufactured footplate (14) includes a first hole (see [0028] in reference to each component (including 14) having an aligned hole), the anchor (30 and 38) adapted to uniformly spread a load in the ankle region of the manufactured foot plate (14; the Y-shape of 30 and left and right 38 spreads a load exhibited by 12 over a larger area in the ankle region of the foot plate), the load below a fracture strength of a material of the manufactured foot plate (14; given 14 is not described as breaking upon 30 and 38 receiving a load from the bending of 12; the load is considered below a fracture strength of the material of 14), and
wherein the anchor (30 and 38) allows a shape and a volume of the manufactured foot plate (14) to fit inside a shoe of the patient (see [0032]).
Nobbe does not disclose the manufactured foot plate is produced by “additive manufacturing”. However, this limitation is drawn to an article of manufacture, and therefore the limitation is considered to be a product-by-process limitation that is given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Nonetheless, Zachariasen teaches an analogous footplate (footplate as seen in figure 9) which is produced by additive manufacturing (see [0016] in reference to producing the orthosis by additive manufacturing) for the purpose of eliminating the labor-intensive processes of hand-forming a positive model and making the orthosis, thereby significantly reducing the amount of time it takes to make a custom orthosis (see [0051]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the manufactured footplate as disclosed by Nobbe and to have formed the manufactured footplate by additive manufacturing as taught by Zachariasen in order to have provided an improved method of producing the manufactured footplate that would add the benefit of eliminating the labor-intensive processes of hand-forming a positive model and making the orthosis, thereby significantly reducing the amount of time it takes to make a custom orthosis (see [0051]).
Nobbe as now modified by Zachariasen does not disclose the pre-fabricated strut is a pre-fabricated, single-piece strut, and
each finger including a hole, and the additively manufactured footplate includes a second hole, and a third hole, the second and third holes each aligning the holes in the fingers.
However, Lasher teaches an analogous ankle foot orthosis (brace; see [page 1 ln 55-70]; see figure 1) comprising an analogous portion to be worn on a user’s foot (2; see [pg 1 ln 65-75]; 2 while being a shoe, is a portion of the ankle foot orthosis to be worn on the user’s foot, and therefore is considered analogous to the manufactured footplate of Nobbe) and an analogous pre-fabricated strut (4; see [Page 1 ln 75-80]; see figure 1; 4 is pre-fabricated prior to the assembly of the orthosis) comprising a distal end (forked end; see figures 1 and 2) having a pair of fingers (left and right 5; see [pg 1 ln 100-108]; see figures 1 and 2); the pre-fabricated strut (4) is a pre-fabricated, single-piece strut (see figure 2 that 4 and 5 are formed as a single-piece strut), and
each finger (left and right 5) including a hole (see figure 2 that left and right 5 each have a hole for receiving 5a), and the portion to be worn on the user’s foot (2) including a second hole, and a third hole (see figure 2 that left and right sides of 3 each have a hole for receiving 5a) the second and third holes each aligning the holes in the fingers (left and right 5; see figure 2 that the holes formed through left and right 5, and into left and right sides of 3 align with one another for receiving 5a) for the purpose of attaching the strut to the portion to be worn on a user’s foot to provide a firm means of support to the user’s ankle (see [pg 2 ln 1-11]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-fabricated strut, the fingers of the pre-fabricated strut, and the additively manufactured footplate as disclosed by Nobbe as now modified by Zachariasen and to formed the pre-fabricated strut as a single piece (thereby forming a pre-fabricated, single-piece strut), and to have included the holes in each of the fingers and the second and third holes in the foot portion which align with each other and receive an attachment mechanism as taught by Lasher in order to have provided an improved pre-fabricated strut that would add the benefit of increasing the ease of manufacturing as the pre-fabricated strut would be produced simultaneously in one step, and the benefit of attaching the strut to the additively manufactured foot plate to provide a firm means of support to the user’s ankle (see [pg 2 ln 1-11]).
In regards to claim 13, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses further comprising an ankle bending stiffness (12 being made from a composite material (see [abstract]) has an ankle bending stiffness as per applicant’s specification [0007] which states composite materials have specific bending stiffnesses) and a dynamic response (12 being a flat spring exhibits more restoring forces when bent more, thus exhibiting dynamic responses in response to the level of bending), wherein one or more of the ankle bending stiffness and the dynamic response is adjusted by adding or removing one or more plates (20; see [0021]; see figure 3) to the pre-fabricated single-piece strut (12 of Nobbe as now modified by Lasher; the addition of 20 changes the stiffness of 12 (and thus an ankle bending stiffness) as well as the dynamic response of 12 to said ankle bending).
In regards to claim 14, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe as now modified by Zachariasen and Lasher does not disclose wherein the additively manufactured footplate is adapted to be formed by a tree structure support during an additive manufacturing process, the additively manufactured footplate and the tree support structure comprising a single material, and wherein the tree support structure includes a support structure for material extrusion for the additively manufactured footplate, and wherein at least one anchor of the tree structure support is removable from the additively manufactured footplate without using a chemical for dissolving a support material.
However, these limitations are drawn to an article of manufacture, and therefore the limitations are considered to be product-by-process limitations that are given patentable weight only for the structural limitations imparted to the final product by the process. When a claim is directed to a device, the process steps are not germane to the issue of patentability. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps (emphasis added). Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. “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.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
In regards to claim 15, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses the pre-fabricated single-piece strut (12 of Nobbe as now modified by Lasher) further comprising a proximal end (upper end of 12; see figure 3) adapted to be coupled to the calf cuff (16; see figure 3 that the upper end of 12 couples to 16), the proximal end (upper end of 12) having two holes (28; see [0028]; see figure 3).
In regards to claim 28, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses wherein the pre-fabricated single-piece strut (12 of Nobbe as now modified by Lasher) includes a portion with a shape (shape of the lower portion of 12; see figure 3), and wherein the additively manufactured foot plate (14 of Nobbe as now modified by Zachariasen) has a portion with a shape (upper end of 14; see figure 3)) complimentary to the shape of the portion (shape of the lower portion of 12) of the pre-fabricated single-piece strut (12; see figure 3 that the lower portion of 12 and the upper portion of 14 are shaped complimentary to one another).
In regards to claim 29, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses wherein a collective shape and volume of the manufactured foot plate (14 of Nobbe as now modified by Zachariasen) and the pre-fabricated single-piece strut (12 of Nobbe as now modified by Lasher) together are adapted to fit inside a shoe of the patient (see [0032] in reference to the device fitting into an average adult shoe with the lower portion of 12 being positioned above the heel portion; however if a user were wearing high top shoes or boots, the lower portion of 12 would be received within a user’s shoe as claimed).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nobbe in view of Zachariasen and Lasher as applied to claim 1 above, and further in view of Devreese (US 2006/0276736 A1).
In regards to claim 7, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe further discloses the use of composite material for the pre-fabricated, single-piece strut (see [Abstract]). However, Nobbe as now modified by Zachariasen and Lasher does not disclose wherein the pre-fabricated single-piece strut comprises metal, including spring steel.
However, Devreese teaches an analogous ankle foot orthosis (dynamic orthosis; see [0042]; see figure 1) comprising an analogous footplate (1; see [0044]; see figure 1), an analogous calf cuff (2; see [0045]; see figure 1), and an analogous pre-fabricated, single-piece strut (3; see [0046]; see figure 1) wherein the pre-fabricated, single-piece strut (3) comprises metal, including spring steel (see [0051] any suitable springy metallic material is considered to encompass metal, including spring steel) for the analogous purpose of providing a degree of assistance to the user’s ankle (see [0049]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the composite material of the pre-fabricated, single-piece strut as disclosed by Nobbe as now modified by Zachariasen and Lasher and to have formed the strut from a metal, including spring steel as taught by Devreese in order to have provided an improved pre-fabricated single-piece strut that would add the benefit of providing a degree of assistance to the user’s ankle (see [0049]). Furthermore, such a modification is held to be obvious in view of Devreese teaching the strut can be made from either metallic or composite materials (see [0051]) thereby suggesting metals and composites are known equivalents to one another.
Claim(s) 8 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nobbe in view of Zachariasen and Lasher as applied to claim 1 and 15 above, and further in view of Storup et al. (US 2019/0000659 A1) (hereinafter Storup).
In regards to claim 8, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe as now modified by Zachariasen and Lasher does not disclose further comprising one or more plates connected to the pre-fabricated single-piece strut to help increase flexural stiffness of the ankle-foot orthosis, each of the plates includes a proximal end having at least two holes adapted to align with the proximal end of the pre-fabricated single-piece strut and a distal end having at least one hole adapted to align with a hole in the anchor of the pre-fabricated, single-piece strut.
However, Storup teaches an analogous ankle foot orthosis (30; see [0056]; see figure 3a) comprising an analogous foot plate (31; see [0057]; see figure 3a), an analogous calf cuff (38; see [0057]; see figure 3a), and an analogous pre-fabricated single-piece strut (32; see [0056]; see figure 3a), further comprising one or more plates (additional 32) connected to the pre-fabricated single-piece strut (32; see figure 3b) to help increase flexural stiffness of the ankle-foot orthosis (see [0058] adjusting 32 by addition or removal of the additional 32 increases and decreases the flexural stiffness providing a greater or less rigid orthotic), each of the plates includes a proximal end having at least two holes (upper two 36; see [0057]; see figure 3b) adapted to align with the proximal end of the pre-fabricated, single-piece strut (32) and a distal end having at least one hole (lower third 36; see [0057]; see figure 3b) adapted to align with the hole of the pre-fabricated, single-piece strut (32; see figure 3b that the holes of 32 and additional 32 align) for the purpose of customizing the device to the individual needs of each user (see [0058]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-fabricated single-piece strut as disclosed by Nobbe as now modified by Zachariasen and Lasher and to have included the one or more plates which comprise a proximal end having at least two holes for aligning with the proximal end of the pre-fabricated single-piece strut, and a distal end having at least one hole adapted to align with a hole in the distal end of the pre-fabricated single-piece strut and are configured to be attached to the pre-fabricated single-piece strut as taught by Storup in order to have provided an improved pre-fabricated single-piece strut that would add the benefit of customizing the device to the individual needs of each user (see [0058]) by including or removing the additional plates as needed.
In regards to claim 16, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe as now modified by Zachariasen and Lasher does not disclose further comprising one or more plates, each plate having a proximal end and a distal end, the proximal end having two holes adapted to align with the holes of the proximal end of the pre-fabricated, single-piece strut, and the distal end having a hole adapted to align with the hole in the center portion of the anchor of the distal end of the pre-fabricated, single-piece strut.
However, Storup teaches an analogous ankle foot orthosis (30; see [0056]; see figure 3a) comprising an analogous foot plate (31; see [0057]; see figure 3a), an analogous calf cuff (38; see [0057]; see figure 3a), and an analogous pre-fabricated single-piece strut (32; see [0056]; see figure 3a), further comprising one or more plates (additional 32) each plate having a proximal end (upper end of 32; see figure 3b) and a distal end (lower end of 32; see figure 3b), the proximal end having two holes (upper two 36; see [0057]; see figure 3b) adapted to align with holes of the pre-fabricated single-piece strut (32; see figure 3b) and the distal end having at least one hole (lower third 36; see [0057]; see figure 3b) adapted to align with the hole of the distal end of the pre-fabricated single-piece strut (32; see figure 3b that the holes of 32 and additional 32 align) for the purpose of customizing the device to the individual needs of each user (see [0058]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-fabricated single-piece strut as disclosed by Nobbe as now modified by Zachariasen and Lasher and to have included the one or more plates which comprise a proximal end having at least two holes for aligning with the holes of the proximal end of the pre-fabricated single-piece strut, and a distal end having at least one hole adapted to align with a hole in the distal end of the pre-fabricated single-piece strut and are configured to be attached to the pre-fabricated single-piece strut as taught by Storup in order to have provided an improved pre-fabricated single-piece strut that would add the benefit of customizing the device to the individual needs of each user (see [0058]) by including or removing the additional plates as needed.
Claim(s) 9 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nobbe in view of Zachariasen and Lasher as applied to claim 1 and 12 above, and further in view of Sivak et al. (US 2009/0306801 A1) (hereinafter Sivak).
In regards to claim 9, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe as now modified by Zachariasen and Lasher does not disclose further comprising an inertia measurement unit disposed on the pre-fabricated single-piece strut near the additively manufactured calf cuff, the inertia measurement unit adapted to measure one or more of gait motion and patient data during use.
However, Sivak teaches an analogous ankle foot orthosis (device seen in figure 2b) comprising an analogous foot plate (lower portion of the device seen in figure 2b) and an analogous pre-fabricated, single-piece strut (strut as seen in figure 2b) further comprising an inertia measurement unit (pedometer/accelerometer sensor, and pressure sensor; see [0028] all three sensors measure the foot’s inertia for monitoring a user’s gait) disposed on the pre-fabricated, single-piece strut (see [0028]; see annotated figure 2b below), the inertia measurement unit (pedometer/accelerometer sensor, and pressure sensor) adapted to measure one or more of gait motion and patient data during use (see [0028]) for the purpose of monitoring the patient’s gait cycle (See [0028]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-fabricated, single-piece strut as disclosed by Nobbe as now modified by Zachariasen and Lasher and to have included the inertia measurement unit disposed on the pre-fabricated, single-piece strut as taught by Sivak in order to have provided an improved pre-fabricated, single-piece strut that would add the benefit of monitoring the patient’s gait cycle (See [0028]), thereby allowing for a monitoring of the patient’s gait to ensure proper healing of the user’s limb and effectiveness of the device.
With regards to the limitation of the inertia measurement unit disposed on the pre-fabricated, single-piece strut near the additively manufactured calf cuff, as seen in the annotated figure 2b below, Sivak teaches the sensors can be embedded within the device including regions near the upper end of the pre-fabricated, single-piece strut. The inclusion of the sensor as these locations would place the sensor as claimed near the calf cuff.
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In regards to claim 17, Nobbe as now modified by Zachariasen and Lasher discloses the invention as discussed above.
Nobbe as now modified by Zachariasen and Lasher does not disclose further comprising an inertia measurement unit disposed on the pre-fabricated, single-piece strut near the additively manufactured calf cuff, the inertia measurement unit adapted to measure a gait motion.
However, Sivak teaches an analogous ankle foot orthosis (device seen in figure 2b) comprising an analogous foot plate (lower portion of the device seen in figure 2b) and an analogous pre-fabricated, single-piece strut (strut as seen in figure 2b) further comprising an inertia measurement unit (pedometer/accelerometer sensor, and pressure sensor; see [0028] all three sensors measure the foot’s inertia for monitoring a user’s gait) disposed on the pre-fabricated, single-piece strut (see [0028]; see annotated figure 2b below), the inertia measurement unit (pedometer/accelerometer sensor, and pressure sensor) adapted to measure a gait motion of the patient (see [0028]) for the purpose of monitoring the patient’s gait cycle (See [0028]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the pre-fabricated, single-piece strut as disclosed by Nobbe as now modified by Zachariasen and to have included the inertia measurement unit disposed on the pre-fabricated, single-piece strut as taught by Sivak in order to have provided an improved pre-fabricated, single-piece strut that would add the benefit of monitoring the patient’s gait cycle (See [0028]), thereby allowing for a monitoring of the patient’s gait to ensure proper healing of the user’s limb and effectiveness of the device.
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