DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/12/2026 has been entered. The previous objection to the claims is withdrawn in light of applicant’s amendments. Claims 1-23 remain pending in this application.
Response to Arguments
Applicant's arguments filed 1/12/2026 have been fully considered but they are not persuasive.
With regard to applicant’s argument that Fago does not teach forming a sliding surface at a residual limb or a subject, the examiner disagrees. Fago clearly teaches myoplasty, which is a procedure in which the muscles are brought over the end of the bone and sewn to the opposing group. The examiner maintains that the cut distal femur bone taught by Fago is construed to be a sliding surface formed at a residual limb of a subject over which the sutured muscles traverse and are able to work antagonistically as a muscular sling, sliding back and forth over the distal end of the bone, particularly if they are not firmly stabilized by scar tissue, and therefore meet the limitations as claimed.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., muscle spindles and golgi organs remain active and the brain receives real-time position and force feedback effectively rebuilding the biological control loop) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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.
Claim(s) 1-3, 8-10, 17, 20, and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2007/0162150 A1 to Fago et al. (Fago).
Regarding at least claim 1
Fago teaches a modular implant that provides an improved surface for interfacing with an external prosthesis (abstract). Fago meets the limitations of a method of providing proprioceptive feedback in a residual limb of a subject, comprising: a) forming a sliding surface at a residual limb of a subject, wherein the sliding surface is in the residual limb; and b) forming a linkage between a pair of agonist and antagonist muscles that traverses the sliding surface, whereby contraction of one of the muscles of the pair causes elongation of the other of the pair, thereby providing proprioceptive feedback to the subject (paragraph 0006 discloses an above knee amputation which involves cutting the femur 14 transversely at the required level of amputation, see figs. 1 and 2, and then performing myodesis/myoplasty by suturing the agonist and antagonists of the knee at 28 together over the distal end 20a of the cut femur – the distal end of the cut femur of Fago is construed to meet the limitation of a sliding surface formed at a residual limb of a subject and the pair of agonist and antagonist muscles sutured together over the distal end of the cut femur, meets the limitation of forming a linkage that traverses the sliding surface such that contraction of one of the muscles of the pair causes elongation of the other of the pair, thereby providing proprioceptive feedback as disclosed in paragraph 0068).
Regarding at least claim 2
Fago teaches the method of claim 1, wherein the sliding surface is formed at a distal end of a bone of the residual limb (paragraph 0006 discloses that the sliding surface is formed at a distal end of a bone of the residual limb by cutting the femur).
Regarding at least claim 3
Fago teaches the method of claim 2, wherein the sliding surface is transverse to a plane in which major longitudinal axes of the pair of agonist and antagonist muscles of the residual limb lie (paragraph 0006 discloses that the femur is cut to form the sliding surface which is transverse to a plane in which a major longitudinal axis of the muscle pair lies; fig. 2).
Regarding at least claim 8
Fago teaches the method of claim 1, wherein the sliding surface is a groove at a distal end of a bone of the residual limb (fig. 2 shows that the sliding surface over which the muscle pair is sutured is a groove).
Regarding at least claim 9
Fago teaches the method of claim 8, wherein the bone is at least a portion of at least one member of the group consisting of a tibia, a fibula, a femur, a humerus, a radius, and an ulna (the bone is a femur as disclosed in paragraph 0006).
Regarding at least claim 10
Fago teaches the method of claim 8, including forming a sliding surface at the distal cut end of the femur. Fago also teaches that an object of the invention is to stabilize the myodesis/myoplasty closures by both providing additional surface area for configuring the soft tissues, and providing porous fixation for those soft tissues to stabilize them as active muscular forces return (paragraph 0042). The additional surface area used to stabilize the soft tissues is construed to be a formed retinaculum at the sliding surface that stabilizes the linkage of the pair of agonist and antagonist muscles at the groove, particularly since the term “retinaculum” is any of various instruments or devices used to hold an organ, tissue, or body part in position.
Regarding at least claim 17
Fago teaches the method of claim 2, wherein the bone is a femur. Fago also contemplates below the knee lower extremity amputations that include at least a portion of a tibia and a fibula (paragraphs 0073-0074). Fago also teaches that a bridging implant is placed between the distal location of both the tibia and fibula cut bones providing an even larger area for direct weight transfer, to enable the weight at mid-stride to be transferred down into the external prosthetic leg socket to the most distal location, in order to gain operative power from the reattachment of otherwise not utilized muscle (22) (paragraphs 0073 and 0075). In this instance, the sliding surface of Fago is formed by constructing a tibia- fibula bridge between distal ends of the tibia and the fibula, whereby the tibia-fibula bridge defines the sliding surface, as claimed.
Regarding at least claim 20
Fago teaches the method of claim 17, wherein the sliding surface supports a plurality of linkages between agonist and antagonist muscles (paragraph 0006 discloses that other muscles 22 may also be sutured to the distal bundle such that the sliding surface of the cut distal femur supports a plurality of linkages between muscles).
Regarding at least claim 23
Fago teaches the method of claim 1, wherein the pair of agonist and antagonist muscles are linked by at least one member of the group consisting of muscle tissue, a tendon, and a synthetic material (the suture linking the muscle pair is a synthetic material; paragraph 0006).
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.
Claim(s) 4-7, 11-16, 18, 19, 21, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fago.
Regarding at least claim 4
Fago teaches the method of claim 1, including a sliding surface at the cut distal end. Fago also teaches that an object of the invention is to stabilize the myodesis/myoplasty closures by both providing additional surface area for configuring the soft tissues, and providing porous fixation for those soft tissues to stabilize them as active muscular forces return (paragraph 0042). It is therefore clear that Fago intends to stabilize the soft tissues while allowing the muscles to slide across the groove in the cut distal end of the femur (fig. 2).
[AltContent: textbox (groove)][AltContent: arrow]
PNG
media_image1.png
218
284
media_image1.png
Greyscale
However, Fago does not explicitly teach wherein the sliding surface is a synovial sleeve attached to a bone of the residual limb.
There is no evidence of record that establishes that specifying that the sliding surface is a synovial sleeve would result in a difference in function of the Fago device, since the groove of the cut distal end performs the function of allowing the sutured muscle pair to slide in a stabilized manner. Further, a person having ordinary skill in the art, being faced with modifying the sliding surface of Fago, would have a reasonable expectation of success in making such a modification and it appears the groove of the cut distal end would function as intended being the claimed synovial sleeve. Lastly, applicant has not disclosed that the claimed synovial sleeve solves any stated problem, indicating that “another embodiment” includes securing a synovial sleeve to form a sliding surface, and offering other acceptable embodiments (e.g., grooved end, specification at para. [0074]) and therefore there appears to be no criticality placed on the synovial sleeve as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sliding surface of Fago to be a synovial sleeve as an obvious matter of design choice within the skill of the art.Regarding at least claim 5
Fago teaches the method of claim 4, including a sliding surface that is a grooved end, modified by obvious design choice to be a synovial sleeve, at a distal end of the bone (fig. 2). However, Fago does not teach wherein the synovial sleeve is at a side portion of the bone.
There is no evidence of record that establishes that specifying that the sliding surface/synovial sleeve is at a side portion of the bone would result in a difference in function of the Fago device. Further, a person having ordinary skill in the art, being faced with modifying the placement of the sliding surface of Fago, would have a reasonable expectation of success in making such a modification and it appears the sliding surface would function as intended being the positioned at a side portion of the bone. Lastly, applicant has not disclosed that the claimed synovial sleeve being at a side portion of the bone solves any stated problem, indicating that “in one embodiment” the synovial sleeve is at a side portion of the bone, and offering other acceptable embodiments (e.g., at a distal end of the bone, specification at para. [0064]) and therefore there appears to be no criticality placed on the positioning of the sliding surface/synovial sleeve as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the positioning of the sliding surface/synovial sleeve of Fago to be at a side surface of the bone as an obvious matter of design choice within the skill of the art.
Regarding at least claim 6
Fago teaches the method of claim 4, wherein the sliding surface/synovial sleeve is at a distal end of the bone (fig. 2 shows the grooved end at a distal end of the bone).
Regarding at least claim 7
Fago teaches the method of claim 1, wherein a sliding surface is formed, and wherein a pair of agonist and antagonist muscles are linked, whereby the sliding surface supports the pair of agonist and antagonist muscles (paragraph 0006).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the invention of Fago, which includes forming a sliding surface wherein a pair of agonist and antagonist muscles are linked, whereby the sliding surface supports the pair of agonist and antagonist muscles, to include that a plurality of sliding surfaces are formed, and wherein a plurality of pairs of agonist and antagonist muscles are linked, whereby each sliding surface supports at least one pair of agonist and antagonist muscles, since it has been held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced.
Regarding at least claim 11
Fago teaches the method of claim 10, including forming a retinaculum. However, Fago does not teach wherein the retinaculum is formed of a synthetic material.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to specify that the retinaculum is formed of a synthetic material, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 12
Fago teaches the method of claim 10, including forming a retinaculum. However, Fago does not teach wherein the retinaculum is formed of at least one tissue selected from the group consisting of a tendon and a ligament.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to specify that the retinaculum is formed of a synthetic material, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 13
Fago teaches the method of claim 8, including securing the linkage of the pair of the pair of agonist and antagonist muscles at the distal end of the bone while allowing sliding of the linkage across the sliding surface (paragraph 0006 discloses a grooved cut distal end across which the muscle pair slides and paragraph 0042 discloses providing additional surface area for configuring the soft tissues, and providing porous fixation for those soft tissues to stabilize them as active muscular forces return). However, Fago does not teach further including wrapping the distal end of the bone with a material to secure the linkage of the pair of agonist and antagonist muscles at the distal end of the bone while allowing sliding of the linkage across the sliding surface.
There is no evidence of record that establishes that wrapping the distal end of the bone with a material would result in a difference in function of the Fago device, since the muscle pair slides across the grooved cut distal end of the bone and additional surface area stabilizes the soft tissues as active muscular forces return. Further, a person having ordinary skill in the art, being faced with modifying the stabilization feature of Fago, would have a reasonable expectation of success in making such a modification and it appears stabilized linkage would function as intended being the claimed wrapped distal end of the bone. Lastly, applicant has not disclosed that the claimed synovial sleeve solves any stated problem, indicating that “optionally” the bone tissue at the distal end is wrapped, and offering other acceptable embodiments (e.g., grooved end, specification at para. [0074]) and therefore there appears to be no criticality placed on the wrapped distal end as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the grooved cut distal end of Fago, which allows the muscles to slide, to be wrapped as an obvious matter of design choice within the skill of the art.
Regarding at least claim 14
Fago teaches the method of claim 13, further including at least one step selected from the group consisting of forming the groove in the distal end of the bone to thereby form the sliding surface, and forming a retinaculum at the sliding surface that stabilizes the pair of agonist and antagonist muscles at the groove (fig. 2 shows a groove formed in the distal end of the bone to thereby form the sliding surface as claimed).
Regarding at least claim 15
Fago teaches the method of claim 13, including securing the linkage of the pair of muscles at the distal end of the bone. However, Fago does not teach wherein the wrapping material is formed of a synthetic material.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to specify that the wrapping material is formed of a synthetic material, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 16
Fago teaches the method of claim 15, wherein the synthetic material includes at least one member of the group consisting of titanium, silicone, plastic, ceramic, and chromium cobalt.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to specify that the synthetic material includes at least one member of the group consisting of titanium, silicone, plastic, ceramic, and chromium cobalt, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 18
Fago teaches the method of claim 17, including a bridge. However, Fago does not teach wherein the bridge is an osseous bridge.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to specify that the bridge is an osseous bridge, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claim 19
Fago teaches the method of claim 17, including a bridge. However, Fago does not teach wherein the bridge is a tendonous bridge.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to specify that the bridge is a tendonous bridge, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07).
Regarding at least claims 21-22
Fago teaches the method of claim 1, including a sliding surface that is a grooved end, modified by obvious design choice to be a synovial sleeve, at a distal end of the bone (fig. 2). However, Fago does not teach wherein the sliding surface is defined by a tendonous ring fixed to a distal end of the residual limb, which is a distal end of a bone.
There is no evidence of record that establishes that specifying that the sliding surface is defined by a tendonous ring fixed to a distal end of the residual limb, which is a distal end of a bone, would result in a difference in function of the Fago device. Further, a person having ordinary skill in the art, being faced with modifying the sliding surface of Fago, would have a reasonable expectation of success in making such a modification and it appears the sliding surface would function as intended being defined by a tendonous ring fixed to a distal end of the residual limb, which is a distal end of a bone. Lastly, applicant has not disclosed that the claimed a tendonous ring fixed to a distal end of the residual limb solves any stated problem, indicating that “another embodiment” includes forming a tendonous ring, and offering other acceptable embodiments (e.g., grooved end, etc., specification at para. [0074]) and therefore there appears to be no criticality placed on the configuration of the sliding surface as claimed such that it produces an unexpected result.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sliding surface of Fago to be defined by a tendonous ring fixed to a distal end of the residual limb, which is a distal end of a bone, as an obvious matter of design choice within the skill of the art.
Conclusion
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. See 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 MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774