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 .
Status of Claims
This office action is in response to the patent application 18/886,935 originally filed on September 16, 2024. Claims 1-20 were originally presented for examination.
In the preliminary amendment filed April 25, 2025, claims 1-20 were canceled and claims 21-39 were introduced as new claims. Of the new claims, claims 21 and 34 are independent. Claims 21-39 are now pending examination.
Information Disclosure Statement
The Information Disclosure Statement filed on April 25, 2025 has been considered. An initialed copy of the Form 1449 is enclosed herewith.
Priority
This application is a continuation of US patent application 16/987,759, filed August 7, 2020. This application claims priority of US provisional application 62/883,968, filed August 7, 2019.
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 21-33 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.
Claim 21, and substantially similar limitations in claim 23, recites the limitation “a model arm.” The limitation is originally introduced earlier in claim 21. As such, the subsequent limitations are either (1) not following antecedent basis (i.e. “[[a]] the model arm”); or (2) are intended to be new limitations which ambiguously conflict with the previous limitation of claim 21. Therefore, claims 21 and 23 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. Claim 22-33 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 21. Claim 24 and 28-33 are also rejected under 35 U.S.C. § 112(b), based on their respective dependencies to claim 23.
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.
Claims 21-27 and 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (US 2019/0274834) in view of Makower et al. (hereinafter “Makower,” US 2010/0145449).
Regarding claim 21, and substantially similar limitations in claim 34, Johnson discloses an apparatus comprising:
a joint that pivotally connects an upper member of a model arm and a lower member of a model arm (Johnson [0074], “an exemplary nano-magnetic prosthetic joint may be suitable for: a hip joint prosthesis, a knee joint prosthesis, a shoulder joint prosthesis, an ankle joint prosthesis, or an elbow joint prosthesis, etc,” an elbow joint prosthesis would connect the upper and lower members of an arm); and
…
wherein rotation of the joint caused by rotation of the lower member changes an angular orientation of the magnetic elements (Johnson [0038], “an exemplary embodiment of the present invention provides an exemplary embodiment of a prosthetic joint comprising correlated magnet pairs programmed to attract and/or repel with a prescribed force and engagement distance, or to attract and/or repel at a certain spatial orientation.”); and
wherein the magnetic elements repel each other in a first angular orientation and attract each other in a second angular orientation (Johnson [0098], “an exemplary embodiment of the present invention an exemplary embodiment of the present invention provides an exemplary embodiment of a prosthetic joint comprising correlated magnet pairs programmed to attract and/or repel with a prescribed force and engagement distance, or to attract and/or repel at a certain spatial orientation.”).
Johnson does not teach a feedback mechanism comprising first and second magnetic elements that are positioned so as to provide audible and tactile feedback when the joint is moved during performance of a reduction procedure.
However, Makower discloses a feedback mechanism comprising first and second magnetic elements that are positioned so as to provide audible and tactile feedback when the joint is moved during performance of a reduction procedure (Makower [0020], “an audible sound such as a click is created by the collar or adjustment assembly when it is unlocked or locked to provide feedback to the physician. Also, audible sounds or tactile feedback can be provided to the physician as the collar or adjustment assembly is translated along the length of the shaft. Such feedback can be incorporated both into unlocking the energy absorbing device as well as for translating components of the device to new positions.”).
Makower is analogous to Johnson, as both are drawn to the art of medical devices. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Johnson, to include a feedback mechanism comprising first and second magnetic elements that are positioned so as to provide audible and tactile feedback when the joint is moved during performance of a reduction procedure, as taught by Makower, in order to provide the feedback necessary to indicate relative movement between the parts (Makower [0153]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 22, and substantially similar limitations in claim 36, Johnson does not teach wherein the feedback mechanism is configured to fit within a recess of a bottom end of the upper member.
However, Makower discloses wherein the feedback mechanism is configured to fit within a recess of a bottom end of the upper member (Makower Fig. 1A, showing the implant device including feedback mechanism configured to fit within a bottom end of the upper member).
Makower is analogous to Johnson, as both are drawn to the art of medical devices. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Johnson, to include wherein the feedback mechanism is configured to fit within a recess of a bottom end of the upper member, as taught by Makower, in order to provide the feedback necessary to indicate relative movement between the parts (Makower [0153]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 23, Johnson does not teach every limitation of wherein the apparatus comprises a shaft for affixing the feedback mechanism at a first point to the upper member of a model arm and at a second point to the lower member of the model arm.
However, Makower discloses wherein the feedback mechanism is configured to fit within a recess of a bottom end of the upper member (Makower Fig. 1A, showing the implant device fitting within a bottom end of the upper member).
Makower is analogous to Johnson, as both are drawn to the art of medical devices. It would be obvious to try by one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method as taught by Johnson, to include wherein the feedback mechanism is configured to fit within a recess of a bottom end of the upper member, as taught by Makower, in order to provide the feedback necessary to indicate relative movement between the parts (Makower [0153]). Doing so is a predictable solution that one of ordinary skill in the art could have pursued with a reasonable expectation of success.
Regarding claim 24, and substantially similar limitations in claim 37, Johnson in view of Makower discloses wherein the magnetic elements of the feedback mechanism are mounted on the shaft, and wherein the second magnetic element can be linearly displaced along the shaft (Johnson [0031], “the present invention provides a solution that leverages the embedded magnetic granules/grains, the magnetic pattern, shape, and/or bulk geometric structure, or nano-magnetic particles, or programmable magnets, etc. to create a low friction “cushion” between two surfaces of a prosthetic joint.”).
Regarding claim 25, Johnson in view of Makower discloses wherein the first magnetic element is positioned within a proximal portion of an upper member recess and the second magnetic element is positioned within a joint member recess (see Johnson Fig. 4C and [0114], “In the depicted embodiment of FIG. 4C, hardened magnetic nano-particles are partially embedded on the lower top portion of the femoral head 420 and the upper top portion of the tibia component 422.”).
Regarding claim 26, and substantially similar limitations in claim 38, Johnson in view of Makower discloses wherein the magnetic elements are spaced at a distance at which they repel each other when the upper member and the lower member of the model arm are in an initial bent orientation associated with a bending of the joint (Johnson [0123], “The magnetic system also may be engineered with a distinct and separate force curve to also lightly repel aligned or partially aligned if the components are too close.”).
Regarding claim 27, and substantially similar limitations in claim 35, Johnson in view of Makower discloses wherein the magnetic elements are moved closer together causing the magnetic elements to forcefully attract each other, when the lower member of the model arm is pivoted downward by a user via movement of the joint (Johnson [0125], “The correlated magnet pair 1100 are programmed to attract or repel with a prescribed force and engagement distance, and, to attract or repel at certain spatial orientations.”).
Allowable Subject Matter
Claims 28-33 are dependent upon a prior art-rejected base claim, but would be allowable if (1) rewritten in independent form including all of the limitations of the base claim and any intervening claims, and (2) the 35 USC 112(b) issues in claims 21 and 23 are resolved.
Claim 39 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.
These claims have allowable subject matter because they recite a cam element interfacing with the joint structures. None of the cited prior art references of record contemplate integrating a cam element with the magnetic joint elements.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Takasu et al. (US 2013/0122478) Human phantom training aid for mastering manipulative techniques and method for mastering manipulative techniques using human phantom training aid
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/STEPHEN ALVESTEFFER/Examiner, Art Unit 3715
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