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 .
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The NPL articles referenced on pages 20-21 have not been provided and therefore have not been considered.
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 1-26 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 1 recites the limitation "the ankle" in line 2, “the brace” in line 6 and “the side” in line 7. There is insufficient antecedent basis for these limitations in the claim. It is suggested these limitations read –an ankle--, --the leg brace--, and –a side--.
Claim 1 further recites that “a strut, upright connecting the leg brace to the foot support component at a certain length” which is grammatically incorrect but also unclear what is meant by upright connecting and if the strut is upright or if there is an additional upright structure. It is also unclear what is meant by a “certain” length, and if this can be any length or if it is limited to a particular length. Applicant’s specification does not clarify what the “certain” length is, so it is being interpreted as –an upright strut connecting the leg brace to the foot support component at a length--.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). Claim 1 recites “a contact plate configure to contact a walking surface”. The term “plate” is generally accepted to be a round, flat, thin piece of material whereas applicant’s plate is a curved, narrow, and blade-like (see page 1 lines 28-30). Claim 2 then goes on to recite the contact plate has an un-flat region. The term is indefinite because the specification does not clearly redefine the term and the term appears to be inconsistent with the generally accepted meaning.
Claim 4 recites the limitation "the foot plantar surface" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites “a surface” in line 3. It is unclear if this is the same as, or different than, the walking surface recited in claim 1.
Claim 6 recites the limitation "the convex curved shaped region" in line 1 and “the roll-over shape (ROS)” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation "the curve shaped region" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites “the contact plate additionally comprises a frontal plane oriented-curve configured to reproduce a medial-lateral shift in a center of pressure during walking”. The only place the frontal plant is mentioned in the specification is in the Summary of the invention on page 2, but does not provide any other details. It is unclear what is meant by this limitation or how it limits the scope of the claim. Clarification or deletion of this limitation is requested.
Claim 11 recites the limitation "the shank" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the overall curvature" and “the curve shape” in line 1. There is insufficient antecedent basis for this limitation in the claim. Furthermore, the claim recites “the curve shape is between 0.1, 0.5, and 0.8 times the patients’ height”. It is unclear what “between 0.1, 0.5, and 0.8 means. Is it between 0.1-0.5, 0.5-0.8, or 0.1-0.8? This is also indefinite because the claim appears to recite dimensions of the invention relative to the height of a person. The height of a person can vary, the height of the person is not defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree. Therefore, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention since the curve is claimed as a ratio relative to an unknown dimension. It is also noted that there are not units of measure for the “curvature”. For example, if the person is 60 inches tall, it appears that the “curvature” would be between 6 inches, 30 inches, and 48 inches in which case the length of the “curvature” of the device is almost as tall as the person. It is not clear how a person could even walk with a device almost as tall as they are on the foot in light of the invention.
Claim 13 recites the limitation "the leg" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the leg" in line 2, “the ankle” in line 2, “the side” in line 4, “the support” in line 7 and “the brace” in line 7. There is insufficient antecedent basis for these limitations in the claim. Claim 14 also recites “not shadowing said foot from a ground”. It is unclear what is meant by “not shadowing” and applicant’s specification provides no disclosure of what is meant by the phrase. Claim 14 also recites “the support is provided downright from the brace”. It is unclear what is meant by “downright”. It is being interpreted as --the foot support component is provided downward from the brace--. It is noted that the phrase “orthosis apparatus brace” in lines 2-3 is redundant and should consider reciting “a brace”.
Claim 17 recites the limitation "the foot plantar surface" in 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites the limitation "the shank" in line 2. There is insufficient antecedent basis for this limitation in the claim. The same issue applies to claim 19.
Claim 21 recites the limitation "the foot plantar surface" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 21 also recites “the contact plate at a height above the foot plantar surface thereby offloading all of the weight to the foot”. This is unclear because the claim already recited that when the contact plate is below the foot surface it offloads all the weight. One would expect that if the contact plate is above the foot surface it would not offload all the weight but rather none.
Claim 22 recites the limitation "the selected heigh", “the level”, and “the foot plantar surface” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 25 recites the limitation "the adjusting of offload step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 26 recites the limitation "the ankle" in line 2 and “the side” in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
The remaining claims are rejected due to their dependency.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-13 and 26 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 1 recites “the contact plate is positioned at the side of the foot” which positively recites the human body. It is suggested applicant use –configured to—or similar language to obviate the rejection. The same issue applies to claim 26.
Claim 11 recites “wherein the area above the ankle is located on the shank”. It is suggested applicant use –configured to—or similar language to obviate the rejection.
The remaining claims are rejected due to their dependency.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12, 14-16, and 18-26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vecsey (US 6,997,891 B1).
Regarding claim 1, Vecsey discloses an orthosis apparatus (10) for offloading weight from a foot of a patient (Figure 1; Abstract), comprising a leg brace (20), sized and shaped to attach to an area above the ankle (Figure 1, 20 attaches around the lower leg); at least one foot support component comprising a contact plate configured to contact a walking surface (as best understood, foot portion 38 which contacts the walking surface at 40; Figures 1-3); and a strut (36), upright connecting the leg brace (20) to the foot support component (38) at a certain length between the brace and the foot support component (Figures 1-2), wherein the contact plate is positioned at the side of the foot (Figures 1 and 3); and wherein the orthosis apparatus is configured to offload weight by providing support extending downwards to the contact plate (Figure 1; Col. 2, lines 17-24 and 36-46).
Regarding claim 2, Vecsey discloses wherein the contact plate comprises a convex un-flat region (at 40, Figures 1-3), sized and shaped to provide a rolling motion when contacting a surface (Figures 1-3; Col. 2, lines 25-27).
Regarding claim 3, Vecsey discloses wherein the contact plate is further sized and shaped to provide the off loading of weight is rolling motion (Figure 1; Col. 2, lines 25-27; Col. 3, lines 33-37).
Regarding claim 4, Vecsey discloses wherein the certain length between the brace and the foot support component is adjustable so as to position the contact plate at a height which can be selected to be above, below or at the foot plantar surface (Col. 2, lines 36-46).
Regarding claim 5, Vecsey discloses wherein the contact plate comprises a convex curve shaped region (at 40), sized and shaped to provide a rolling motion when contacting a surface (Figures 1-3; Col. 2, lines 25-27).
Regarding claim 6, Vecsey discloses wherein the convex curved shaped region is shaped and sized to provide a rolling motion in the sagittal plane that reproduces the roll-over shape (ROS) obtained by a non injured leg during walking (Figures 1-3; Col. 2, lines 25-27).
Regarding claim 7, Vecsey discloses wherein the curve shaped region comprises at least two distinct curved regions having a different degree of curvature deviation from an axis (the curvature at the heel portion is different than the curvature at the middle portion, see Figure 1).
Regarding claim 8, as best understood Vecsey discloses wherein the contact plate additionally comprises a frontal plane oriented-curve configured to reproduce a medial-lateral shift in a center of pressure during walking (the front of the curved portion at 40 is curved, see Figure 1; also, see Figure 3 which shows it curved when viewed from the front).
Regarding claim 9, Vecsey discloses wherein the brace is fabricated to fit a patient's leg by use of computer generated design based on scanning the leg (it is noted this is a product by process limitation and the end product is the same. 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)
Regarding claim 10, Vecsey discloses at least 2 foot support components, each configured to be positioned at a different side of the foot (See Figures 2 and 3).
Regarding claim 11, Vecsey discloses wherein the area above the ankle is located on the shank (Figure 1).
Regarding claim 12, Vecsey discloses the orthosis apparatus having a curvature with a curve shape (Figures 1-3), and is capable of placement on a user such that the overall curvature of the curve shape is between 0.1, 0.5 and 0.8 times the patient’s height (depending on the height of the user to which it is applied).
Regarding claim 14, Vecsey discloses a method of offloading weight from a foot of a patient (Abstract), the method comprising: suspending the leg of the patient at an area above the ankle in an orthosis apparatus brace (10; Figure 1; Abstract), wherein the foot is positioned below the knee (Figure 1); providing support at the side of the foot with a foot support component having a contact plate (as best understood, foot portion 38 which contacts the walking surface at 40; Figures 1-3), situated at the side of the foot and connected by a strut (36) to the brace (20) and not shadowing said foot from a ground (as best can be understood, the foot is not shadowed from the ground since there is no structure between the foot and the ground, Figures 1 and 3), wherein the support is provided downright from the brace to the contact plate, thereby offloading weight from the foot to the area above the ankle (Figure 1; Col. 2, lines 17-24 and 36-46; Col. 3, lines 25-37).
Regarding claim 15, Vecsey discloses supporting at least two sides of the foot (Figures 1 and 3; Col. 1, lines 17-30).
Regarding claim 16, Vecsey discloses adjusting the offloading of weight between the foot and the area above the ankle by positioning the contact plate at a height relative to 1-2 millimeter steps over or under the height of the foot plantar surface (Vecsey discloses the adjusting the support so that it is even with the foot and therefore falls within the range of between 1-2 millimeter steps over or under the foot; Col. 2, lines 36-46; Col. 3, lines 23-37).
Regarding claim 18, Vecsey discloses wherein the area above the ankle is located on the shank (Figure 1).
Regarding claim 19, Vecsey discloses measuring and/or monitoring the amount of load transmitted to the foot and/or to the shank (adjusting the height of the support members to the desired heigh depending on whether full support or partial support is desired; Col. 2, lines 40-46; Col. 3, lines 23-37).
Regarding claim 20, Vecsey discloses wherein said contact plate comprises a convex curve shaped region, sized and shaped to provide a rolling motion when contacting a surface (Figures 1-2; Col. 2, lines25-27; Col. 3, lines 32-37).
Regarding claim 21, Vecsey discloses adjusting the offload of weight by one or more of: positioning the contact plate at a height below the foot plantar surface thereby offloading all of the weight to the area above the ankle (Figure 1; Col. 2, lines 36-46; Col. 3, lines 25-37); positioning the contact plate at a height above the foot plantar surface thereby offloading all of the weight to the foot; or positioning the contact plate at a selected height at about the level of the foot plantar surface, thereby offloading part of the weight from the foot to the area above the ankle (Figure 1; Col. 2, lines 36-46; Col. 3, lines 25-37); wherein adjusting the height of the contact plate is effected by changing the length between the brace and the foot support component (Figure 1; Col. 2, lines 36-46; Col. 3, lines 25-37).
Regarding claim 22, Vecsey discloses wherein the selected height at about the level of the foot plantar surface, ranges between 30 millimeters over to 30 millimeters under the plantar foot surface (Figure 1; Col. 2, lines 36-46; Col. 3, lines 25-37).
Regarding claim 23, Vecsey discloses wherein the contact plate is comprises a convex curve shaped region, sized and shaped to provide a rolling motion when contacting a surface (Figures 1-2; Col. 2, lines25-27; Col. 3, lines 32-37).
Regarding claim 24, Vecsey discloses wherein the adjusting is provided in steps in accordance to a disease progress, exercise needs and/or rehabilitation level (Col. 2, lines 42-46; Col. 3, lines 23-37).
Regarding claim 25, Vecsey discloses wherein the adjusting of offload step is provided for a defined time frame (Col. 3, lines 26-37).
Regarding claim 26, Vecsey discloses an orthosis apparatus (10) for offloading weight from a foot of a patient (Abstract, Figure 1), comprising: a leg brace (20), sized and shaped to attach to an area above the ankle (Figure 1); and at least one foot support component, comprising a contact plate, wherein the at least one foot support component is connected to the leg brace; wherein the contact plate (as best understood, foot portion 38 which contacts the walking surface at 40; Figures 1-3) comprises a convex un-flat region, sized and shaped to provide a rolling motion when contacting a surface, and wherein the contact plate is positioned at the side of the foot (Figure 1; Col. 2, lines 17-27 and 36-46).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Vecsey (US 6,997,891 B1) in view of Franke et al (US 8,540,655 B2).
Regarding claim 13, Vecsey discloses that as applied above but does not disclose wherein the device further comprises a sensor which collects information indicating the amount of load offloaded from the foot to the leg. Franke discloses a weight-bearing brace that comprises a sensor which collects information indicating the amount of load offloaded from the foot to the leg (Col. 12, lines 45-54). It would have been obvious to one of ordinary skill in the art at the time of filing to provide the device of Vecsey having a sensor as taught by Franke for monitoring the load while preventing further injury to the user.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Vecsey (US 6,997,891 B1).
Regarding claim 17, Vecsey discloses that as applied above and discloses adjusting the offloading of weight between the foot and the area above the ankle by positioning the contact plate at a height relative to about the height of the foot plantar surface so as to provide full or partial support is desired (Col. 2, lines 40-46; Col. 3. Lines 23-37), wherein said height effects an offload over movement along a roll over curve while the foot takes part in a walking movement (Col. 2, lines 21-27 and 40-46; Col. 3. Lines 23-37). Vecsey does not specify wherein an offload of between 200gr and 2 kg off the foot over at least 10% of movement. However, at the time the invention was made, it would have been obvious to a person of ordinary skill in the art to provide an offload between 200gr and 2 kg over 10% of movement, since applicant has not disclosed that between 200 gr and 2 kg over 10% provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either design. Furthermore, absent a teaching as to criticality that between 200 gr and 2 kg over 10% provides an advantage, solves any stated problem, or is used for any particular purpose, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA). One of ordinary skill in the art, furthermore, would have expected Vecsey, and applicant' s invention, to perform equally well with either the device by Vecsey or the claimed amount because both would perform the same function of providing an offload weight from the foot of the user. Therefore, it would have been prima facie obvious to modify Vecsey to obtain the invention as specified in claim 17 or any other amount to provide the optimal offload weight for the user. It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kari Rodriquez whose telephone number is 571-270-1909. The examiner can normally be reached Monday-Friday 6-3 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786