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 .
Priority
Applicant’s claim for the benefit of a prior-filed application 18/539,596 (now US 12324762 B2) under 35 U.S.C. 119(e), 120, 121, 365(c) or 386(c), is acknowledged.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 21-41 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12324762 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because as seen in the comparison table the claims are substantially identical in scope.
Instant Application
U.S. Patent No. US 12324762 B2
Claim 21:
An ankle/foot orthosis, comprising:
a foot part, which has a sole configured to receive a foot; and
a shin part having an elongate gutter shape that is configured to extend along a length of a shin, the shin part being configured to extend along and contact a frontal aspect of the shin, the shin part being connected to the foot part via a spring;
the spring comprising a first arc and a second arc, wherein the first arc is configured to extend medially from the foot part and to extend inwardly in a direction of an ankle to form a hinge area, and
wherein the second arc is configured to curve laterally and anteriorly from the hinge area to merge into the shin part,
wherein the hinge area forms a furthest posterior position of the spring.
Claim 1:
An ankle/foot orthosis, comprising:
a foot part, which has a sole configured to receive a foot;
a shin part having an elongate gutter shape or cup shape that is configured to extend along a length of a shin, the shin part being configured to extend along and bear on a frontal aspect of the shin and being connected to the foot part via a spring;
(minor differences but substantially the same scope)
the spring further comprising a first arc and a second arc, the first arc being configured to extend medially from the foot part and to extend in an arc behind an ankle in a lateral direction to form a hinge area, and
wherein the second arc is configured to curve laterally and anteriorly from the hinge area to merge into the shin part,
wherein the first arc has a larger medial bulge than the second arc and the hinge area forms a furthest posterior position of the spring.
Claim 22:
The ankle/foot orthosis of claim 21, wherein the spring and the shin part are made in one piece.
Claim 2:
The ankle/foot orthosis of claim 1, wherein the spring and the shin part are made in one piece.
Claim 23:
The ankle/foot orthosis of claim 21, wherein the spring is configured to extend proximally substantially parallel to the shin.
Claim 4:
The ankle/foot orthosis of claim 1, wherein the spring is configured to extend proximally substantially parallel to the shin.
24. (New) The ankle/foot orthosis of claim 21, wherein the spring and the foot part are made in one piece from a fiber-reinforced plastic.
5. The ankle/foot orthosis of claim 1, wherein the spring and the foot part are made in one piece from a fiber-reinforced plastic.
25. (New) The ankle/foot orthosis of claim 21, wherein foot part, the shin part, and the spring are permanently connected, bonded or laminated together.
6. The ankle/foot orthosis of claim 1, wherein foot part, the shin part, and the spring are permanently connected, bonded or laminated together.
26. (New) The ankle/foot orthosis of claim 21, wherein the hinge area is designed to be torsionally stable about a proximal-distal axis.
7. The ankle/foot orthosis of claim 1, wherein the hinge area is designed to be torsionally stable about a proximal-distal axis.
27. (New) The ankle/foot orthosis of claim 21, wherein the hinge area is designed to be flexurally stiff in a medial-lateral direction.
28. (New) The ankle/foot orthosis of claim 21, wherein the spring has a width measured in an anterior-posterior direction that tapers from the foot part in a posterior and proximal direction such that a smallest width measured in the anterior-posterior direction is along a portion of the spring.
8. The ankle/foot orthosis of claim 1, wherein the hinge area is designed to be flexurally stiff in a medial-lateral direction.
9. The ankle/foot orthosis of claim 1, wherein the spring has a width measured in an anterior-posterior direction that tapers from the foot part in a posterior and proximal direction such that a smallest width measured in the anterior-posterior direction is along a portion of the spring.
29. (New) The ankle/foot orthosis of claim 21, wherein the shin part has a greater length in a longitudinal dimension than a width in a medial/lateral direction.
10. The ankle/foot orthosis of claim 1, wherein the shin part has a greater length in a longitudinal dimension than a width in a medial/lateral direction.
30. (New) The ankle/foot orthosis of claim 21, wherein the shin part is flexurally stiff in a medial plane.
11. The ankle/foot orthosis of claim 1, wherein the shin part is flexurally stiff in a medial plane.
Claim 31:
An ankle/foot orthosis, comprising:
a foot part, which has a sole configured to receive a foot; and
a shin part having an elongate gutter shape that is configured to extend along a length of a shin, the shin part being further configured to contact a frontal aspect of the shin, the shin part being connected to the foot part via a spring;
wherein the spring comprises a first arc and a second arc, the first arc being configured to extend medially inward from the foot part behind a natural ankle joint axis to form a hinge area, and
the second arc being configured to curve laterally and anteriorly from the hinge area to merge into the shin part,
wherein the hinge area forms a furthest posterior position of the spring.
Claim 1:
An ankle/foot orthosis, comprising:
a foot part, which has a sole configured to receive a foot;
a shin part having an elongate gutter shape or cup shape that is configured to extend along a length of a shin, the shin part being configured to extend along and bear on a frontal aspect of the shin and being connected to the foot part via a spring;
(minor differences but substantially the same scope)
the spring further comprising a first arc and a second arc, the first arc being configured to extend medially from the foot part and to extend in an arc behind an ankle in a lateral direction to form a hinge area, and
[behind ankle is behind a natural ankle joint axis] (further see: 19. The ankle/foot orthosis of claim 1, wherein the first arc is configured to extend from the foot part to the ankle at an angle in a posterior and proximal direction, and wherein a front edge of the spring is configured to extend behind a natural ankle joint axis, and wherein the second arc is configured to extend obliquely in an anterior and proximal direction until the second arc extends parallel to a tibia proximally.)
wherein the second arc is configured to curve laterally and anteriorly from the hinge area to merge into the shin part,
wherein the first arc has a larger medial bulge than the second arc and the hinge area forms a furthest posterior position of the spring.
32. (New) The ankle/foot orthosis of claim 31, wherein the spring and the shin part are made in one piece.
2. The ankle/foot orthosis of claim 1, wherein the spring and the shin part are made in one piece.
33. (New) The ankle/foot orthosis of claim 31, wherein the spring is configured to extend proximally substantially parallel to the shin.
4. The ankle/foot orthosis of claim 1, wherein the spring is configured to extend proximally substantially parallel to the shin.
34. (New) The ankle/foot orthosis of claim 31, wherein the spring and the foot part are made in one piece from a fiber-reinforced plastic.
5. The ankle/foot orthosis of claim 1, wherein the spring and the foot part are made in one piece from a fiber-reinforced plastic.
35. (New) The ankle/foot orthosis of claim 31, wherein foot part, the shin part, and the spring are permanently connected, bonded or laminated together.
6. The ankle/foot orthosis of claim 1, wherein foot part, the shin part, and the spring are permanently connected, bonded or laminated together.
36. (New) The ankle/foot orthosis of claim 31, wherein the hinge area is designed to be torsionally stable about a proximal-distal axis.
7. The ankle/foot orthosis of claim 1, wherein the hinge area is designed to be torsionally stable about a proximal-distal axis.
37. (New) The ankle/foot orthosis of claim 31, wherein the hinge area is designed to be flexurally stiff in a medial-lateral direction.
8. The ankle/foot orthosis of claim 1, wherein the hinge area is designed to be flexurally stiff in a medial-lateral direction.
38. (New) The ankle/foot orthosis of claim 31, wherein the spring has a width measured in an anterior-posterior direction that tapers from the foot part in a posterior and proximal direction such that a smallest width measured in the anterior-posterior direction is along a portion of the spring.
9. The ankle/foot orthosis of claim 1, wherein the spring has a width measured in an anterior-posterior direction that tapers from the foot part in a posterior and proximal direction such that a smallest width measured in the anterior-posterior direction is along a portion of the spring.
39. (New) The ankle/foot orthosis of claim 31, wherein the shin part has a greater length in a longitudinal dimension than a width in a medial/lateral direction.
10. The ankle/foot orthosis of claim 1, wherein the shin part has a greater length in a longitudinal dimension than a width in a medial/lateral direction.
Claim 40:
An ankle/foot orthosis, comprising: a foot part, which has a sole configured to receive a foot; and
a shin part having an elongate gutter shape that is configured to extend along a length of a shin, the shin part being further configured to contact a frontal aspect of the shin, the shin part being connected to the foot part via a spring;
wherein the spring comprises a first arc and a second arc, the first arc being configured to extend medially inward a direction of an ankle from the foot part behind a natural ankle joint axis to form a hinge area, and
the second arc being configured to curve laterally and anteriorly from the hinge area to merge into the shin part,
wherein the hinge area forms a furthest posterior position of the spring, and
wherein the foot part, the shin part, and the spring are integrally formed together.
Claim 1:
An ankle/foot orthosis, comprising:
a foot part, which has a sole configured to receive a foot;
a shin part having an elongate gutter shape or cup shape that is configured to extend along a length of a shin, the shin part being configured to extend along and bear on a frontal aspect of the shin and being connected to the foot part via a spring;
(minor differences but substantially the same scope)
the spring further comprising a first arc and a second arc, the first arc being configured to extend medially from the foot part and to extend in an arc behind an ankle in a lateral direction to form a hinge area, and
[behind ankle is behind a natural ankle joint axis] (further see: 19. The ankle/foot orthosis of claim 1, wherein the first arc is configured to extend from the foot part to the ankle at an angle in a posterior and proximal direction, and wherein a front edge of the spring is configured to extend behind a natural ankle joint axis, and wherein the second arc is configured to extend obliquely in an anterior and proximal direction until the second arc extends parallel to a tibia proximally.)
wherein the second arc is configured to curve laterally and anteriorly from the hinge area to merge into the shin part,
wherein the first arc has a larger medial bulge than the second arc and the hinge area forms a furthest posterior position of the spring.
Claim 15:
The ankle/foot orthosis of claim 1, wherein the spring, the shin part, and the foot part are made in one piece.
[one piece and integral the same scope] [note independent claim 21 also maps more directly herein]
41. (New) The ankle/foot orthosis of claim 21, wherein the first arc is attached medially to the foot part and extends posteriorly and proximally from the foot part.
19. The ankle/foot orthosis of claim 1, wherein the first arc is configured to extend from the foot part to the ankle at an angle in a posterior and proximal direction, and wherein a front edge of the spring is configured to extend behind a natural ankle joint axis, and wherein the second arc is configured to extend obliquely in an anterior and proximal direction until the second arc extends parallel to a tibia proximally. (first arc extends medial in claim 1 thus is attached medially, and extends posterior and proximal direction)
Claim 42 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 19 of U.S. Patent No. US 12324762 B2 in view of CAESAR (US 2440894 A).
Regarding claim 42, U.S. Patent No. US 12324762 B2 claims wherein the first arc is configured to extend laterally in the direction posterior to the ankle after reaching the furthest medial point (claim 19, “the first arc is configured to extend from the foot part to the ankle at an angle in a posterior and proximal direction”, first arc goes in a direction posterior to the ankle).
U.S. Patent No. US 12324762 B2 does not claim the first arc extending laterally after reaching the furthest medial point.
However, Caesar teaches an analogous spring 21/22 with a first arc 28/29 wherein the first arc 28/29 is configured to extend laterally in the direction posterior to the ankle after reaching the furthest medial point (Fig. 1-2, the first arc as best seen in Fig. 2 has a furthest medial point at which it begins to extend laterally afterwards, wherein as seen with Fig. 1-2 the direction is posterior to the ankle).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have provided the shape of the first arc/spring of Caeser such that the first arc extending laterally after reaching the furthest medial point in order to provide improved pressure feel for the patient from the spring action (Caeser Col. 4 lines 8-45)
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 claim 42 (wherein the first arc is configured to extend laterally in the direction posterior to the ankle after reaching the furthest medial point) 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.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: there is lack of antecedent basis of the term “the furthest medial point” and in general claim 42 (wherein the first arc is configured to extend laterally in the direction posterior to the ankle after reaching the furthest medial point).
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.
Claim 31-40 and 42 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.
Claims 31 and 40 recites “the first arc being configured to extend medially inward” is confusing. Medially is interpreted as "lying or extending toward the median axis of the body", and in this instance it can be interpreted as inward toward the main axis of the body or the main axis of the leg. Medial is the extent toward a median axis, so it already means "inward," but by including "inward" in the claim it is unclear if medially is not intended to not mean inward within the claim. For the sake of compact prosecution, the Examiner will interpret medial to be relative to the body as a whole as is common with ankle orthosis and inward to be a clarifier of inward relative to the body rather than a modifier.
Claim 42 recites “the furthest medial point”. There is a lack of antecedent basis for this limitation.
Claims 32-39 are rejected as being depending on a rejected claim.
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.
Claims 21-23, 25, 28, 31-33, 35, 38 and 40-42 are rejected under 35 U.S.C. 103 as being unpatentable over Caesar (US 2440894) in view of Shlomovitz (US 2009/0198166).
Regarding claim 21, Caesar discloses an ankle/foot orthosis (Fig 1), comprising:
a foot part 1, which has a sole 5 configured to receive a foot (Fig 1, foot part 1 with sole 5);
a shin part 35 having an elongate gutter shape that is configured to extend along a length of a shin (Fig 6, shin part 35, elongated gutter as it is extended is width, also extends along a length of the shin although not directly thereon),
the shin part 35 being connected to the foot part 1 via a spring 21/22 (Fig. 1-5, spring 21/22 has arcs 28/29/30 that connect the foot part 1 to the shin part 35)
the spring 21/22 further comprising a first arc and a second arc (Fig 1, first arc 28, second arc 29/30),
the first arc 28 being configured to extend medially from the foot part and to extend inwardly in a direction of an ankle to form a hinge area (Fig 1, Fig 2, first arc portion 28 extends medially from the foot part 1 and then extends inwardly towards the ankle to form a hinge area), and
wherein the second arc 29/30 is configured to curve laterally and anteriorly from the hinge area to merge into the shin part (Fig 1-2, second arc 30 extend laterally and then has an anterior curve to merge with shin part 35).
Caesar does not disclose the shin part being configured to extend along and contact a frontal aspect of the shin, and wherein the hinge area forms a furthest posterior position of the spring.
Shlomovitz teaches an analogous spring for an ankle having a foot member, spring, and shin member (Fig 1, foot member 110, spring 130, shin member 146), the shin part being configured to extend along and bear on a frontal aspect of the shin and being connected to the foot part via a spring (Fig 1), further wherein the analogous spring 130 has a first arc 130/131 extending in a direction of the ankle to form an analogous hinge area 130 (area pointed to by reference number 130 specifically in Fig. 3) and a second arc 132 that curves laterally and anteriorly away from the hinge area 130 to merge into the shin member 146, wherein the hinge area 13 forms a furthest posterior position of the spring (Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shin part of Caesar to bear on the front of the shin as taught by Shlomovitz in order for the spring to better respond to the ankle of the leg and the foot (Shlomovitz [0152], [0153], [0154]), and to modify the spring shape such that the hinge area forms a furthest posterior position of the spring, in order to ensure the hinge lines up with the ankle joint of the user (see Shlomovitz [0144], lines up above the ankle thus hinging/flexing with the joint therein).
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Regarding claim 22, Caesar/Shlomovitz discloses the invention of claim 21 above.
Ceaser discloses wherein the spring and the shin part are made in one piece (Caesar Fig 1, members of the shin and spring and foot part are combined/made into/in one piece before a user would apply the device or during use so interpreted as one piece).
Furthermore, providing the spring and shin part as one piece does not appear to be critical to the function of the invention as disclosed.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have made the components of Caesar/Shlomovitz to be made in one piece, as MPEP 2144.04(V)(B) “Making Integral” provides that making a one-piece integral construction from separate parts would be of obvious engineering choice without any present criticality towards this limitation:
[In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice."); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form "a single integral and gaplessly continuous piece." Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.).]
Regarding claim 23, Caesar/Shlomovitz discloses the invention of claim 21 above.
Caesar discloses wherein the spring is configured to extend proximally substantially parallel to the shin (Fig. 1-2, second arc 30 of the spring extends substantially parallel a shin of the user).
Regarding claim 25, Caesar/Shlomovitz discloses the invention of claim 21 above.
Caesar/Shlomovitz discloses wherein foot part, the shin part, and the spring are permanently connected, bonded or laminated together (“Are permanently connected” is interpreted as intended use, wherein the user may keep all the components of Caesar/Shlomovitz shown in Fig. 1 of each to be permanently connected by the user).
Regarding claim 28, Caesar/Shlomovitz discloses the invention of claim 21 above.
Caesar discloses wherein the spring has a width measured in an anterior-posterior direction that tapers from the foot part in a posterior and proximal direction such that a smallest width measured in the anterior-posterior direction is along a portion of the spring (See Annotated Figure of Caesar below, wherein the spring 21/22 has a width at the foot part measured in an anterior-posterior direction, wherein then when extending from the foot part in a posterior and proximal direction there is a smallest width measured in the anterior posterior direction along a portion of the spring, two distinct widths of the spring with one larger and the other smaller, thus the smallest therein).
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Regarding claim 31, Caesar discloses an ankle/foot orthosis (Fig 1), comprising:
a foot part 1, which has a sole 5 configured to receive a foot (Fig 1, foot part 1 with sole 5);
a shin part 35 having an elongate gutter shape that is configured to extend along a length of a shin (Fig 6, shin part 35, elongated gutter as it is extended is width, also extends along a length of the shin although not directly thereon),
the shin part 35 being connected to the foot part 1 via a spring 21/22 (Fig. 1-5, spring 21/22 has arcs 28/29/30 that connect the foot part 1 to the shin part 35)
the spring 21/22 further comprising a first arc and a second arc (Fig 1, first arc 28, second arc 29/30),
the first arc 28 being configured to extend medially inward from the foot part behind a natural ankle joint axis to form a hinge area (Fig 1, Fig 2, first arc portion 28 extends medially from the foot part 1 and then extends inwardly towards the ankle to form a hinge area, extends behind the natural joint and thus behind the natural joint axis therein), and
wherein the second arc 29/30 is configured to curve laterally and anteriorly from the hinge area to merge into the shin part (Fig 1-2, second arc 30 extend laterally and then has an anterior curve to merge with shin part 35).
Caesar does not disclose the shin part being configured to extend along and contact a frontal aspect of the shin, and wherein the hinge area forms a furthest posterior position of the spring.
Shlomovitz teaches an analogous spring for an ankle having a foot member, spring, and shin member (Fig 1, foot member 110, spring 130, shin member 146), the shin part being configured to extend along and bear on a frontal aspect of the shin and being connected to the foot part via a spring (Fig 1), further wherein the analogous spring 130 has a first arc 130/131 extending in a direction of the ankle to form an analogous hinge area 130 (area pointed to by reference number 130 specifically in Fig. 3) and a second arc 132 that curves laterally and anteriorly away from the hinge area 130 to merge into the shin member 146, wherein the hinge area 13 forms a furthest posterior position of the spring (Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shin part of Caesar to bear on the front of the shin as taught by Shlomovitz in order for the spring to better respond to the ankle of the leg and the foot (Shlomovitz [0152], [0153], [0154]), and to modify the spring shape such that the hinge area forms a furthest posterior position of the spring, in order to ensure the hinge lines up with the ankle joint of the user (see Shlomovitz [0144], lines up above the ankle thus hinging/flexing with the joint therein).
Regarding claim 32, Caesar/Shlomovitz discloses the invention of claim 31 above.
Ceaser discloses wherein the spring and the shin part are made in one piece (Caesar Fig 1, members of the shin and spring and foot part are combined/made into/in one piece before a user would apply the device or during use so interpreted as one piece).
Furthermore, providing the spring and shin part as one piece does not appear to be critical to the function of the invention as disclosed.
Therefore, it would have been also obvious to one of ordinary skill in the art before the effective filing date to have made the components of Caesar/Shlomovitz to be made in one piece, as MPEP 2144.04(V)(B) “Making Integral” provides that making a one-piece integral construction from separate parts would be of obvious engineering choice without any present criticality towards this limitation:
[In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice."); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form "a single integral and gaplessly continuous piece." Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.).]
Regarding claim 33, Caesar/Shlomovitz discloses the invention of claim 31 above.
Caesar discloses wherein the spring is configured to extend proximally substantially parallel to the shin (Fig. 1-2, second arc 30 of the spring extends substantially parallel a shin of the user).
Regarding claim 35, Caesar/Shlomovitz discloses the invention of claim 31 above.
Caesar/Shlomovitz discloses wherein foot part, the shin part, and the spring are permanently connected, bonded or laminated together (“Are permanently connected” is interpreted as intended use, wherein the user may keep all the components of Caesar/Shlomovitz shown in Fig. 1 of each to be permanently connected by the user).
Regarding claim 38, Caesar/Shlomovitz discloses the invention of claim 31 above.
Caesar discloses wherein the spring has a width measured in an anterior-posterior direction that tapers from the foot part in a posterior and proximal direction such that a smallest width measured in the anterior-posterior direction is along a portion of the spring (See Annotated Figure of Caesar below, wherein the spring 21/22 has a width at the foot part measured in an anterior-posterior direction, wherein then when extending from the foot part in a posterior and proximal direction there is a smallest width measured in the anterior posterior direction along a portion of the spring, two distinct widths of the spring with one larger and the other smaller, thus the smallest therein).
Regarding claim 40, Caesar discloses an ankle/foot orthosis (Fig 1), comprising:
a foot part 1, which has a sole 5 configured to receive a foot (Fig 1, foot part 1 with sole 5);
a shin part 35 having an elongate gutter shape that is configured to extend along a length of a shin (Fig 6, shin part 35, elongated gutter as it is extended is width, also extends along a length of the shin although not directly thereon),
the shin part 35 being connected to the foot part 1 via a spring 21/22 (Fig. 1-5, spring 21/22 has arcs 28/29/30 that connect the foot part 1 to the shin part 35)
the spring 21/22 further comprising a first arc and a second arc (Fig 1, first arc 28, second arc 29/30),
the first arc 28 being configured to extend medially inward from the foot part behind a natural ankle joint axis to form a hinge area (Fig 1, Fig 2, first arc portion 28 extends medially from the foot part 1 and then extends inwardly towards the ankle to form a hinge area, extends behind the natural joint and thus behind the natural joint axis therein), and
wherein the second arc 29/30 is configured to curve laterally and anteriorly from the hinge area to merge into the shin part (Fig 1-2, second arc 30 extend laterally and then has an anterior curve to merge with shin part 35).
Caesar does not disclose the shin part being configured to extend along and contact a frontal aspect of the shin, and wherein the hinge area forms a furthest posterior position of the spring.
Shlomovitz teaches an analogous spring for an ankle having a foot member, spring, and shin member (Fig 1, foot member 110, spring 130, shin member 146), the shin part being configured to extend along and bear on a frontal aspect of the shin and being connected to the foot part via a spring (Fig 1), further wherein the analogous spring 130 has a first arc 130/131 extending in a direction of the ankle to form an analogous hinge area 130 (area pointed to by reference number 130 specifically in Fig. 3) and a second arc 132 that curves laterally and anteriorly away from the hinge area 130 to merge into the shin member 146, wherein the hinge area 13 forms a furthest posterior position of the spring (Fig. 3).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shin part of Caesar to bear on the front of the shin as taught by Shlomovitz in order for the spring to better respond to the ankle of the leg and the foot (Shlomovitz [0152], [0153], [0154]), and to modify the spring shape such that the hinge area forms a furthest posterior position of the spring, in order to ensure the hinge lines up with the ankle joint of the user (see Shlomovitz [0144], lines up above the ankle thus hinging/flexing with the joint therein).
Ceaser discloses wherein the foot part, the shin part, and the spring are integrally formed together. (Caesar Fig 1, members of the shin and spring and foot part are combined/made into/in one piece before a user would apply the device or during use so interpreted as one piece, and thus being integral).
Furthermore, providing the spring and shin part and foot part as being integrally formed together does not appear to be critical to the function of the invention as disclosed.
Therefore, it would have been also obvious to one of ordinary skill in the art before the effective filing date to have made the components of Caesar/Shlomovitz to be integrally formed together, as MPEP 2144.04(V)(B) “Making Integral” provides that making a one-piece integral construction from separate parts would be of obvious engineering choice without any present criticality towards this limitation:
[In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice."); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form "a single integral and gaplessly continuous piece." Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.).]
Regarding claim 41, Caesar/Shlomovitz discloses the invention of claim 21 above.
Caesar discloses wherein the first arc 28/29 is attached medially to the foot part 1 (Fig. 1-2, attached at a medial side therein) and extends posteriorly and proximally from the foot part 1 (Fig. 1-2, extends posteriorly and proximally from the foot part).
Regarding claim 42, Caesar/Shlomovitz discloses the invention of claim 21 above.
Caesar discloses wherein the first arc 28/29 is configured to extend laterally in the direction posterior to the ankle after reaching the furthest medial point (Fig. 1-2, the first arc as best seen in Fig. 2 has a furthest medial point at which it begins to extend laterally afterwards, wherein as seen with Fig. 1-2 the direction is posterior to the ankle).
Claims 24 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Caesar (US 2440894) in view of Shlomovitz (US 2009/0198166), in view of Savard (US 20110196277 A1).
Regarding claim 24/34, Caesar/Shlomovitz discloses the invention of claim 21/34 above.
Caesar/Shlomovitz do not disclose wherein the spring and the foot part are made in one piece from a fiber-reinforced plastic.
However, Savard teaches an analogous orthotic foot brace (title), having an analogous shin part 24 attached to a foot part 21 via a spring 34 (Fig. 4, shows spring bending motion), wherein the spring and the foot part are made in one piece (Fig. 4, combined and secured as one whole piece as a finished product), from a fiber-reinforced plastic (see [0068]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the spring and the foot part of Caesar/Shlomovitz to be made in one piece from a fiber-reinforced plastic as taught by Savard, as a fiber-reinforced plastic spring would have high strength and low weight (Savard [0068]), and Furthermore MPEP 2144.04(V)(B) “Making Integral” provides that making a one-piece integral construction from separate parts would be of obvious engineering choice without any present criticality towards this limitation:
[In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, "that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice."); but see Schenck v. Nortron Corp., 713 F.2d 782, 218 USPQ 698 (Fed. Cir. 1983) (Claims were directed to a vibratory testing machine (a hard-bearing wheel balancer) comprising a holding structure, a base structure, and a supporting means which form "a single integral and gaplessly continuous piece." Nortron argued that the invention is just making integral what had been made in four bolted pieces. The court found this argument unpersuasive and held that the claims were patentable because the prior art perceived a need for mechanisms to dampen resonance, whereas the inventor eliminated the need for dampening via the one-piece gapless support structure, showing insight that was contrary to the understandings and expectations of the art.).]
Claims 26-27 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Caesar (US 2440894) in view of Shlomovitz (US 2009/0198166) in view of Ruotoistenmaki (US 2949111).
Regarding claim 26/36, Caesar/Shlomovitz discloses the invention of claim 21/31 above.
Caesar/Shlomovitz is silent on wherein the hinge area is designed to be torsionally stable about a proximal-distal axis.
However, Ruotoistenmaki teaches an analogous spring and analogous hinge area (Fig 2, spring 5 and hinge area 4) that does not allow twisting movements of the foot (Col 1 lines 38-47, Col 2 lines 58-61) thus is torsionally stable.
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 spring shape of Caesar/Shlomovitz with the flat leaf spring shape as taught by Ruotoistenmaki in order to prevent unwanted movements of the foot (Ruotoistenmaki Col 1 lines 59-60, Col 2 lines 58-61).
Regarding claim 27/37, Caesar/Shlomovitz discloses the invention of claim 21/31 above.
Caesar/Shlomovitz is silent on wherein the hinge area is designed to be flexurally stiff in a medial-lateral direction.
Ruotoistenmaki teaches an analogous ankle orthosis with an analogous hinge (Fig 2, spring 5 and hinge area 4) that is stiff in a side wise, thus medial-lateral, direction (Ruotoistenmaki Col 1 lines 59-60, Col 2 lines 58-61).
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 spring shape of Savard with the flat leaf spring shape as taught by Ruotoistenmaki in order to prevent unwanted movements of the foot (Ruotoistenmaki Col 1 lines 59-60, Col 2 lines 58-61).
Claim 29 and 39 is rejected under 35 U.S.C. 103 as being unpatentable over Caesar (US 2440894) in view of Shlomovitz (US 2009/0198166), and further in view of Warner (US 2009/0105624).
Regarding claim 29/39, Caesar/Shlomovitz discloses the invention of claim 21/31 above.
Caesar/Shlomovitz is silent on wherein the shin part has a greater length in a longitudinal dimension than a width in a medial/lateral direction (Shlomovitz appears this way in Fig 1, but is not explicitly stated or clear enough to infer from the drawings).
Warner teaches an analogous shin part for an ankle orthosis wherein the shin part has a greater length in a longitudinal dimension than a width in a medial/lateral direction (Fig 7, [0031], [0032], oblong shape of aperture and shin member interpreted as longer in the longitudinal dimension than medial/lateral).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the shin part of Caesar/Shlomovitz to be longer in the longitudinal dimension as taught by Warner to better support the shin and stabilize the device (Warner [0032]).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Caesar (US 2440894) in view of Shlomovitz (US 2009/0198166) in view of Ingimundarson (US 2004/0134500).
Regarding claim 29, Caesar/Shlomovitz discloses the invention of claim 21 above.
Caesar/Shlomovitz is silent on wherein the shin part is flexurally stiff in a medial plane.
Ingimundarson teaches an analogous ankle orthosis with an analogous shin part that is detailed to be rigid (Ingimundarson Page 3 paragraph 0040) thus flexurally stiff in all planes.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to replace the shin material of Caesar/Shlomovitz with the stiff material as taught by Ingimundarson in order to maintain the foot in a functional position (Ingimundarson Page 2 paragraph 0017).
Conclusion
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/KEVIN S ALBERS/Patent Examiner, Art Unit 3786
/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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