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 .
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.
Claims 1-3, 5-8, 11-20, 23, and 25 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. In claim 1, lines 15-16, “the threshold” appears to lack a proper antecedent basis if it is not the same as “a threshold” (lines 13 and 18) and “the threshold” (lines 14 and 22-23); a similar problem exists in claim 12. Claims 23 and 25 now depend from a canceled claim.
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.
Claims 1-3, 5-8, 11-20, 23, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Palmer et al., WO 2011/100116 A2, in view of Zahedi et al., US 2014/0379096 A1. Palmer et al. disclose a method for controlling a damping variation in a prosthetic knee with an upper part pivotally coupled to a lower part, a resistance unit, adjustment device, control unit, and sensors (Figures 1-4; paragraphs 0034+, 0038+, 0089+, 0094+); reducing flexion resistance for a swing phase (paragraph 0043); capturing a profile of an ankle moment or torque characteristic acting on the prosthesis when walking or standing (Figure 6; paragraphs 0037, 0045, 0053-0054); ascertaining a maximum moment during a stance phase or when standing (Figure 6; paragraphs 0037, 0057); after reaching maximum, reducing flexion damping during the stance phase to a swing phase damping level if a moment threshold below maximum is reached (paragraphs 0058+), wherein an initial value of flexion damping prior to reduction is set to a value which locks flexion when standing or in the stance phase [paragraphs 0035 (spool valve 104 closed: “stiff mode”), 0093].
Thresholds are time variable (paragraphs 0037, 0050, 0055, 0068) and may be set to depend on walking speeds (paragraphs 0080++): “multiple data files are used with the user walking at different speeds to ensure that the prosthetic joint movement decision values are optimized not only for a single walking speed of the user, but for multiple walking speeds” (paragraph 0081, emphasis added). All decision values or thresholds based on moments, knee angles, and the like are a function of the walking speed determined and the corresponding data file selected, with each data file having prosthetic joint movement decision values or thresholds optimized according to a respective walking speed. The graph of Figure 6 is broadened or narrowed along the time domain, depending on the ascertained walking speed, so associated thresholds being set earlier or later would have been a natural consequence of gait cycle duration and would have been obvious to one of ordinary skill in the art at the effective filing date of the present invention in order to appropriately adapt to the pace of ambulation, with faster movement requiring faster responses to gait phase transitions without prematurely entering a stumble recovery state (paragraphs 0009, 0063, 0092).
Palmer et al. lack specific mention of continuously reducing flexion damping during the stance phase to a swing phase damping level, but Palmer et al. contemplate “a middle mode” and “any other number of modes with resistances between the low resistance and the high resistance” in operations other than binary (paragraph 0093), and Zahedi et al. teach a system for imparting such intermediate modes by utilizing adjustable needle and rotary valves (Figures 1B and 1C; paragraphs 0049-0053). To incorporate such damping resistance control into Palmer et al. would have been obvious in order to impart a number of resistance modes selectable in a continuous manner, with the ordinary practitioner having been left to devise specifics for the Palmer et al. variants (paragraph 0093) and Zahedi et al. describing advantages of continuously reducing flexion particularly during descent [paragraphs 0026 (“reduction in resistance may be stepped or progressive”), 0029 (“some additional support at the end of stance phase”), 0030 (“progressively reduced from the first level to the second level”), 0084], with further motivation (to combine references) provided by the similarities in Zahedi et al. [paragraphs 0008 and 0012 (sensing bending moments and axial forces), 0017 (bending moment profiles), 0110 (“peak moment is relatively late in the stance phase”), 0116 (“immediately after the maximum of the shin bending moment… the knee flexion resistance is reduced to the intermediate level”)].
Flexion damping is increased again when a moment value increases again (Palmer et al.: Figure 14; paragraph 0060), such as during a successive gait cycle, a number of which cycles are represented in Figure 14. Palmer et al. additionally include algorithms for returning the prosthetic joint to a stiff mode (and hence increasing the flexion damping again) if a moment exceeds a first moment boundary value or threshold in the event that “the amputee is standing on his or her toes, has tripped, has stumbled, or is otherwise having an abnormal gait” (Figure 6; paragraphs 0068-0069).
Regarding claims 6 and 17, thresholds may additionally be adjusted or set based on knee angle position (paragraphs 0062, 0075, 0078, 0082, 0092). Regarding claims 7 and 18, although the moment data curve 122 of Figure 6 depicts the swing phase damping trigger T2 level 136 to be somewhat less than 50% of the maximum moment, values above 50% would have been obvious for faster speeds (paragraphs 0009, 0081+) and for athletic or active amputees less prone to stumbling in order to enhance responsiveness to transitions between stance and swing phases (paragraph 0005), with safeguards being present in the control system (abstract, last sentence; Figures 7-8 and 18; paragraphs 0051++). Regarding claims 8 and 19, flexion damping is reduced depending on the profile of the moment (Figure 6; paragraphs 0059-0060). Regarding claims 11 and 20, a substantially (MPEP § 2173.05(b) III. D.) bell-shaped profile is evident from Figures 6 and 14 (moment data 122: paragraph 0045). The further limitations of other claims are adequately addressed above (MPEP § 707).
Response to Arguments
The claim language “is set later” (amended claim 1 at line 15) may be fairly interpreted to mean at a later time (i.e., “later” along a temporal dimension), which is certainly true “when the load characteristic reduces slowly” (claim 1 at line 15), even if “slow” and “quick” thresholds are exactly the same, because the corresponding “slow” load characteristic profile or curve would be spread out over a longer time duration, such that a percentage (e.g., 90% of maximum load) takes longer to attain in comparison to that (i.e., 90% of maximum load) of a load characteristic curve reducing more quickly (Applicant’s claim 1, lines 15-16). Under an alternative interpretation, “is set later” implies “is set to be ‘later’ (or further along) the at least one load characteristic profile” (claim 1, lines 9-12), but as noted in the Office action of May 27, 2025, decision values (i.e., thresholds) are optimized for multiple walking speeds (page 4, lines 7-11), and an “earlier” decision or threshold along the “quick” load characteristic would have been obvious for reasons set forth in the sentence bridging pages 4 and 5 of said Office action, which goes on to state that “athletic or active amputees” (who tend to be quicker) are “less prone to stumbling” (ibid.: page 5, lines 6-10).
Applicant has incorporated modified forms of previous claims 4 and 22 into independent claims 1 and 12, but Applicant’s remarks do not really address examiner’s grounds for rejecting claim 4 and the specific reference to paragraph 0081 of Palmer et al. Applicant misquotes this paragraph by instead reproducing a portion of paragraph 0082 (Applicant’s reply of September 30, 2025: middle of page 12). The optimized movement decision values (plural) for multiple walking speeds (Palmer et al.: paragraph 0081) encompass multiple load or moment decision or threshold values, as further explained in paragraphs 0009, 0037 (“movement data decision values can include” moment decision values), 0057, 0075 (“adjustable parameters can include” moment decision values), 0086-0087 (user can choose to apply the optimized joint movement decision values), and 0091-0093 of Palmer et al.
Conclusion
The examiner notes for the record that Applicant’s response of September 30, 2025, was filed more than four months from the mailing date of the Office action of May 27, 2025, since September 30, 2025, occurs on a Tuesday rather than a Monday.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114 (MPEP § 706.07(b)). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David H. Willse, whose telephone number is 571-272-4762. The examiner can normally be reached on Monday through Thursday. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Melanie Tyson can be reached at telephone number 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID H WILLSE/ Primary Examiner, Art Unit 3774