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 .
Specification
In the Amendments to Specification of August 5, 2026, Applicant has revised paragraph 0031 to address issues with regard to reference character 305, but the examiner is unable to locate this reference character in the drawings as filed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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 12-15, and 29-32 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement and 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. The claims contain subject matter not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor had possession of the claimed invention. In claim 29, the bendable cable and the resiliently deformable element being “in series” (line 2) is neither described nor illustrated; instead, the cable appears to pass through most or all of a compression spring (Figures 12B and 14A-14B) in sort of a collinear or parallel relationship, with direct or indirect attachment being made at a distal rather than a proximal region of the compression spring, with the cable being under tension while the compression spring is under compression (Applicant’s specification: paragraph 0038); the original disclosure lacks any mention or suggestion of a tension spring (or other resiliently deformable element under tension) in series with a cable under tension. Claim 29 lacks support and is vague, indefinite, and confusing as to the scope. In claim 32, line 12, “the upper connection points” lack proper antecedent bases, and there is no discussion in Applicant’s specification of these points being “positioned generally on or above a horizontal plane of the mounting point” (claim 32, lines 12-13). Some of Applicant’s drawings (Figures 2, 3, 6B, 13, 15A-15B) appear to depict a proximal connection point above a horizontal plane of a mounting point and another proximal connection point just below the horizontal plane, so “generally on” a horizontal plane is vague and indefinite as to the scope, particularly in the absence of any explanation in the original disclosure, with the metes and bounds of “horizontal plane” and “mounting point” themselves being vague in light of the specification (e.g., page 8, lines 10-12). In claims 12-15, it is unclear whether the “tensile element” (claims 12 and 14, line 2 of each; claim 13, line 3) is the same as or different from the “bendable cable” newly added to claim 9 at line 3. In claim 31, line 2, --axis-- should be inserted after “instantaneous”. In claims 30-31, it is not understood why the joint is called an “implant”.
Claim Rejections - 35 USC § 102
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 1-2, 4-7, 18-19, and 22-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lührs et al., US 6,749,640 B1, which discloses a prosthetic joint comprising a proximal part 2 having various mounting points on a proximal side (Figures 7-8, 14, 17-19) configured to connect to a proximal prosthetic limb part (column 2, lines 1-4; column 7, lines 14-23); a distal part 1 configured to connect to a distal prosthetic limb part (column 2, lines 1-4; column 8, lines 55-58); a polycentric linkage mechanism connected to proximal and distal parts 2, 1 (Figures 1-8; column 6, lines 1-17; column 7, lines 9-13) and arranged to rotate distal part 1 from an extended position, where distal part 1 is disposed on a distal side of proximal part 2 (Figure 1), to a flexed position, where a portion of distal part 1 is disposed on the proximal side of proximal part 2 (Figures 2-3); the linkage mechanism may provide a range of motion of as much as 175° between extended and flexed positions (column 3, lines 35-38; column 7, lines 3-8); distal part 1 is arranged to rotate relative to proximal part 2 about an instantaneous axis of rotation defining a medial-lateral axis of proximal part 2 (Figure 4; column 1, lines 64-67; column 2, lines 55-61; column 6, lines 1-18; column 7, lines 9-13); first anterior linkages 3, 3´ and posterior linkages 4, 4´ are pivotally connected to proximal part 2 and distal part 1 via connection points 5-8 (Figures 1-3; column 6, lines 1-10; column 7, lines 14-23); the position of an instantaneous axis of rotation is determined by the location of said connection points 5-8 (Figure 4; column 6, lines 10-17); the connection points of first anterior linkages 3, 3´ in some embodiments may be spaced from a mid-plane of proximal part 2 by a smaller distance along the medial-lateral axis than connection points of posterior linkages 4, 4´ (column 7, lines 24-37); distal part 1 is spaced from proximal part 2 in the direction of flexion as the distal part is rotated between extended and flexed positions [Figures 2 (60° excursion) and 3 (140° maximum excursion: column 4, lines 56-60; column 7, lines 3-8) demonstrate that at flexion values beyond 60° and up towards 140°, distal part 1 is spaced apart from proximal part 2 in the direction of flexion; MPEP § 2125]; and in an extended position (e.g., Figure 8), connection points 6 of first anterior linkages 3, 3´ are spaced from certain mounting points, such as posterior rim portions of attachment element 36 or 37, by a smaller distance in the direction of flexion than connection points 7 or 8 of posterior linkages 4, 4´.
Regarding claim 2, because of the proximally (or upwardly) directed bend of posterior linkages 4, 4´ (Figure 5), the “second” angle formed with a longitudinal axis of proximal part 2 is smaller than a “first” angle formed between first anterior linkages 3, 3´ and the longitudinal axis; moreover, all four linkages innately define acute and obtuse angles (inversely related; adding to 180°) with said longitudinal axis. Regarding claim 4, first anterior linkages 3, 3´ are oriented in the direction of flexion in the sense that they are proximally or upwardly angled in that direction (Figure 5); posterior linkages 4, 4´ are bent in the direction of flexion and connection point 7. Regarding claim 5, connection points 5-8 are all disposed on a distal side of a mounting point of attachment element 36 or 37 (Figures 5, 7-8). Regarding claim 7, distal part 1 includes a clamp 31 for releasably securing a portion of the distal prosthetic limb part to a channel within distal part 1 (Figures 5-7, 9-12; column 8, lines 55-58). Regarding claims 18-19, attachment element 36 or 37 of proximal part 2 includes an inner recess and an outer annular recess (Figures 5-8, 20-22, 24) each capable (MPEP § 2114) of engaging a complementarily shaped portion of the proximal prosthetic limb part; attachment element 36 or 37 may also be viewed as a gripping member in that the outer annular recess is capable of being gripped by a grasping or engaging member extending distally from an appropriately configured proximal prosthetic limb part. Regarding claims 6 and 22-25, Figures 2-3 clearly show a spacing of the linkage mechanism from proximal part 2 in a direction of knee flexion such that as flexions approach 140° or 175°, proximal part 2 provides a load path between a mounting point of attachment element 36 or 37 and an external surface abutting near connection point 8; distal part 1 likewise provides a load path to an external surface contacting the region of connection point 5 (Figure 3). Regarding claim 26, the “connection point” of proximal part 2 is somewhat arbitrary and could be viewed, for example, as connection points 8 or an anterior portion of attachment element 36 or 37 so that posterior connection points 7 are spaced a greater distance than anterior connection points 5 from the “connection point” in an extended position (Figures 1, 5, and 7-8). Regarding claim 27, first anterior linkages 3, 3´ cross a plane defined by posterior linkages 4, 4´ during flexion (Figures 1-3; column 2, lines 55-61; column 7, lines 9-13).
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 3 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lührs et al., US 6,749,640 B1. Regarding claim 3, angles within the claimed ranges appear to be shown in Figure 5 and would have been obvious under routine experimentation and/or analysis by one of ordinary skill in the art at the effective filing date of the instant invention in order to match a diversity of users and uses, with Lührs et al. contemplating various relative distances among connection points 5-8 (column 6, line 56, to column 7, line 3). Regarding claim 21, a length of proximal part 2 being about 40 millimeters would have been obvious in order to accommodate relatively long femoral stumps (column 2, lines 1-5); moreover, “as little as” (claim 21, last line) may be interpreted as including larger and/or smaller lengths.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lührs et al., US 6,749,640 B1, in view of Benson, US 2005/0049720 A1. Lührs et al. incorporates a tensioning lock 31 and axial gap 32 for receiving and locking an attachment piece of a distal prosthesis (column 8, lines 55-58; Figures 5-7, 9-12). Benson teaches a quick-release tube clamp 40 which comprises a body 320 formed as an open loop with a pair of ends 350A and 350B spaced from one another by release distance 410 and locked distance 400 (Figures 3-6) across which extends pin or bolt 530 rotatably connected via pivot pin 310 to a lever or handle 300 with camming surface 620 (paragraphs 0019, 0031+, 0037+). To utilize such a quick-release clamp for Lührs et al. would have been obvious from the stated advantages (Benson: paragraphs 0014-0015, 0033, 0041), with further motivation (to combine) provided by the similar purposes (Benson: paragraphs 0004, 0006, 0027), the ordinary practitioner having been left to add further details on the tersely described tensioning lock 31 of Lührs et al.
Claims 9, 11-16, 28, and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Lührs et al., US 6,749,640 B1, in view of Wild, US 2005/0203639 A1. Regarding claim 28 and others, a bendable cable connected to a resiliently deformable element such as a compression spring was known in the art at the effective filing date of the present invention, as seen in Wild (Figures 3A-3F, 4B, 5B, 6B, 7B; abstract; paragraphs 0038, 0040), and would have been obvious for Lührs et al. in view of the advantages pertaining to the gait cycle (Wild: paragraphs 0003, 0008, 0038-0040), with further motivation (to combine) provided by the similarities of the Wild prosthetic knee and the use of hybridization (paragraphs 0006-0007) and by Lührs et al. similarly employing a spring storage mechanism (Lührs et al.: Figure 7 and spring 63; column 3, lines 48-54; column 8, lines 8-21 and 44-54); other features of claim 28 are anticipated by Lührs et al., as explained above. In the Wild system, bendable cable 98 is connected to compression spring 96 at locknut 99 and indirectly to a proximal part via rotatable barrel 74, lever 92, and rear link 30 (Figure 3C; paragraph 0038). Regarding claim 30, cable 98 does not flip to cause the knee joint to flex beyond a certain angle of flexion because compression spring 96 is not affixed so as to be placed under tension and because rotatable barrel would be diametrically sized (as would have been understood by the ordinary practitioner) to accommodate the maximum flexion in Lührs et al., similar to that illustrated in Figure 7B of Wild but with a greater amount of knee flexion as described in Lührs et al. Regarding claims 9, 11-12, and 31, cable 98 generates a force and torque about the instantaneous axis of rotation over a range of motion of the linkage mechanism to urge the joint toward an extended position (Wild: Figures 6B, 7B; paragraph 0040). Regarding claim 13, compression spring 96 and a portion of bendable cable 98 extend through a distal tubular element 95 (Figure 3C; paragraph 0038). Regarding claims 14-15, a hand operated locking member to selectively lock cable 98 would have been obvious from flow control valve 51 of Wild (Figure 2A; paragraph 0040, last sentence) and the limit stops of Lührs et al. (column 2, lines 20-26; column 6, lines 28-31) in order to enable support of a user’s weight at various knee flexion angles. Regarding claim 16, manual torque adjustments would likewise have been obvious from the flow control valve 51 of Wild (Figure 2A; paragraph 0040, last sentence) in order to match the needs of a particular user.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s remarks have been considered but are deemed moot in view of the new grounds of rejection, necessitated by the new claims and by the altered scope of previously filed claims. It is noted for the record that Applicant’s disclosure encompasses multiple mounting points and two or more anterior linkages (specification: page 8, lines 10-12 and 33-36).
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL (MPEP § 706.07(a)). 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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
/DAVID H WILLSE/ Primary Examiner, Art Unit 3774
