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 .
Response to Arguments
Applicant's arguments filed 4/4/2026 have been fully considered but they are not persuasive. Regarding the rejection of claims 1, 5-7, 10, 15, 16, 27, 32, and 60 under 35 U.S.C. 103 as being unpatentable over Bertram in view of Hyde JR, Komistek, and Janssen, applicant argues none of the references disclose a separation distance of no more than about 7 mm between the single magnet and the at least one magnet at the end surface of the tapered volume. Applicant argues that while the Office Action relies on Komistek to assert that the claimed separation distance can be arrived at by routine experimentation, the claimed separation distance provides physiologically relevant forces that would prevent dislocation. Applicant argues it is known that there is an inverse square relationship between magnetic force and separation distance as disclosed by Komistek, therefore an increase in separation distance from 7 mm to 9 mm results in about 40% decrease in magnetic force and such a decrease would negatively impact the functionality of the claimed THR prosthesis. These arguments are not persuasive because Komistek specifically teaches minimizing the distance between the magnets to increase the force between the magnets and prevent dislocation. Therefore, a person of ordinary skill in the art would have found it obvious to optimize the separation distance by routine experimentation to provide for an optimal force to prevent dislocation. For instance, if a person of ordinary skill in the art were to try a 9 mm separation and the force was inadequate, they would decrease the distance to increase the force in light of the teachings of Komistek. In the primary reference Bertram, the opposing magnets are used for an attractive force that prevents dislocation. Obviously, a person of ordinary skill in the art would not settle for a distance that does not provide the desired force. Applicant has not shown that a separation distance of less than about 7 mm provides an unexpected result. It is not surprising that a minimized separation distance results in a greater force. A smaller separation distance produces the expected result of greater force. Therefore, the examiner maintains that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a separation distance of no more than 7 mm because doing so based on the teachings of minimizing the distance as taught by Komistek involves only routine skill in the art and yields predictable results.
Applicant further argues that none of the references disclose a distance of no more than about 5 mm between each of the one or more magnets of the spherical head and the outside surface of the spherical head as set forth in present claim 1. Applicant argues Janssen fails to render this claim element obvious because Janssen does not disclose a minimal distance to the spherical surface, and in fact does not teach any distance between magnets and bearing surfaces, let alone a distance of no more than about 5 mm between the magnets. Applicant argues Janssen is silent as to any starting point or guidance of a distance from which to optimize. This is not persuasive because Janssen specifically states in col. 4, lines 47-56 “The magnet 8 and the element 13 should be embedded in their respective parts 3 and 11 as closely as possible to the respective spherical and trough-shaped surface to achieve strong magnetic forces. However, the spacing of the magnet 8 from its spherical surface and of the element 13 from its trough-shaped surface should be sufficient to prevent the magnet 8 and the element 13 from becoming exposed due to wear-off of the embedding material of the head 3 and the socket 11, respectively”. This passage teaches a person of ordinary skill in the art to embed the magnet as close as possible to the surface of the component while preventing the magnets from being exposed due to wear. The passage clearly sets forth how a distance is measured since Janssen states “the spacing of the magnet 8 from its spherical surface”. The starting point for measuring a distance to the magnet is clearly the spherical surface. From Janssen’s teaching of the general condition of a minimal distance from a magnet to a respective bearing surface, the examiner maintains that a person of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to optimize this distance through routine experimentation to the claimed distance. Applicant argues in cases such as In re Aller or In re Peterson, the prior art disclosed some range or value that overlapped with claimed ranges/values, thus the rationale of routine optimization does not account for differences in distances disclosed in Janssen and the present claims because Janssen does not disclose any distances. This is not persuasive because Janssen discloses a general range of greater than zero (since the magnet should be spaced sufficiently away from the surface to avoid wear) and a minimal distance from the surface to achieve a strong magnetic force. While no specific value is disclosed by Janssen, a person of ordinary skill in the art could and would determine an optimal distance from the surface to achieve both objectives taught by Janssen. Using the general distance range set forth in Janssen, a person of ordinary skill in the art would not need a specific value to determine an optimal distance and would be entirely capable of determining the optimal distance based on the parameters set forth by Janssen.
In conclusion, Bertram discloses the invention substantially as claimed except for the claimed specific arrangements and spacings of the magnets. It seems that it would have been obvious to a person of ordinary skill in the art to modify, if necessary, the magnets of Bertram to the claimed arrangement to achieve optimal attraction forces. Nevertheless, additional references were applied to demonstrate that the magnet arrangement and spacings would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention. Specifically, Hyde teaches the exact arrangement of magnets wherein a magnetic arrangement consists of a single central magnet and an array of six magnets that are each equidistant from the single central magnet, Komistek teaches minimizing the distance between opposing magnets to increase the force between the magnets and prevent dislocation, and Janssen teaches minimizing the distance of a magnet from the surface to achieve strong magnetic forces. Therefore, it would have been prima facie obvious to modify Betram in view of Hyde, Komistek, and Janssen to arrive at the claimed invention in order to design the magnet arrangement and spacing to provide an optimal attraction force to prevent dislocation.
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, 5-7, 10, 15, 16, 27, 32, and 60 are rejected under 35 U.S.C. 103 as being unpatentable Bertram, III US 2003/0236572 (hereafter referred to as Bertram) in view of Hyde, JR. US 2002/0032484 (hereafter referred to as Hyde) in view of Komistek US 2015/0305872 (hereafter referred to as Komistek), and further in view of Janssen et al. US 4,024,588 (hereafter referred to as Janssen).
Regarding claim 1, Bertram discloses a total hip replacement (THR) prosthesis 602, comprising (a) an acetabular component 614 having a full or partial hemispherical shape that comprises a central dome, a periphery, and an intermediate wall therebetween (fig.6), wherein the acetabular component comprises a shell 614 comprising a concave inner surface (the inner surface facing 612), a convex outer surface (the outer surface facing bone), and a thickness therebetween (fig.6), wherein the acetabular component further comprises one or more magnets 616, each comprising a long axis, wherein the one or more magnets comprise a single magnet at the central dome and an array of two or more magnets (fig.6 shows a central magnet and an array of at least two magnets), and (b) a femoral component comprising (i) a stem portion 608 comprising a proximal end (top end) and a distal end (bottom end), (ii) a neck portion comprising a tapered end and a base end, wherein the base end of the neck portion is joined to the proximal end of the stem portion, and the neck portion extends at an angle from the stem portion (see annotated fig.6 below), and (iii) a spherical head 606 that is affixed to the tapered end of the neck portion (fig.6), wherein the spherical head comprises a tapered volume (see the tapered volume which receives the neck in fig.6), an outside surface, and a thickness between the tapered volume and the outside surface (the thickness is the material between the tapered volume and the outside surface), wherein the tapered volume extends inward from the outside surface of the spherical head and is defined by an end surface that is the innermost surface of the tapered volume and walls that extend from the outside surface to the end surface (fig.6), and wherein the tapered volume is configured to receive the tapered end of the neck portion (fig.6; par.26), wherein the spherical head further comprises one magnet 604 comprising a long axis, wherein the magnet is at the end surface of the tapered volume (fig.6 shows the magnet 604 within the neck and within the head at the end surface), wherein the acetabular component is configured to receive all or a portion of the spherical head of the femoral component (fig.6), and wherein the magnets of the acetabular component and the single magnet of the spherical head of the femoral component are oriented to generate an attractive force (fig.6 shows N and S; claim 1 discloses attraction to minimize dislocation or uncoupling of the components).
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Bertram discloses the invention substantially as claimed, however, Bertram does not disclose that the magnets in the acetabular component consist of a single magnet and an array of two or more magnets, wherein every magnet in the array is equidistant from the single magnet at the central dome.
Hyde teaches a ball and socket prosthesis comprising magnets (fig.5B), in the same field of endeavor, wherein a magnetic arrangement consists of a single central magnet 12 and an array of six magnets 14 wherein every magnet in the array is equidistant from the single magnet 12 in the center (fig.1A) for the purpose of maintaining a desired relationship between components (par.11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the acetabular component of Bertram to be limited to a central magnet and an array of equidistant magnets as taught by Hyde since Hyde teaches this is a suitable design for use in a joint prosthesis in order to maintain components in a desired orientation. Bertram discloses “one or, preferably, a plurality of magnets 616” are used in the acetabular component (par.27) and Bertram shows a central magnet and a plurality of magnets around the central magnet in fig.6. Hyde specifically teaches a magnetic array design in a joint prosthesis which is identical to the design of the invention wherein the magnets consist of only a central magnet and an array of equidistant magnets. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the prior art elements of Bertram and Hyde according to known methods to yield predictable results. Bertram further discloses the single magnet at the central dome and the at least one magnet at the end surface of the tapered volume of the spherical head are separated by a distance when the long axis of the single magnet at the central dome is parallel to the long axis of the at least one magnet at the end surface of the tapered volume (fig.6) but neither Bertram nor Hyde discloses a desired separation distance of no more than about 7 mm.
Komistek teaches a THR prosthesis comprising magnets, in the same field of endeavor, wherein the distance between the magnetic components is minimized to increase the force between the magnets and prevent dislocation (par.123-124).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to minimize the separation distance between the magnets of Bertram in view of Hyde as taught by Komistek in order to ensure sufficient magnetic force to prevent dislocation. While Komistek does not disclose a specific value of no more than about 7 mm, Komistek discloses the general conditions of the claim, namely a minimal separation distance, and discloses separation distance is a result effective variable since it affects the magnetic force. Komistek generally teaches minimizing the separation distance and since it has been held that it is not inventive to discover the optimum or workable ranges by routine experimentation and would be an obvious extension of prior art teachings (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A), it would have been obvious to a person of ordinary skill in the art to select a separation distance of no more than 7 mm because doing so based on teachings of minimizing the distance as taught by Komistek involves only routine skill in the art and yields predictable results. Bertram in view of Hyde in view of Komistek discloses the invention substantially as claimed, however, Bertram in view of Hyde in view of Komistek does not disclose that each of the one or more magnets (in the spherical head) is no more than about 5 mm from the outside surface of the spherical head.
Janssen teaches a ball and socket prosthesis comprising magnets (figs.1-5), in the same field of endeavor, wherein the magnets in opposing components should be embedded in their respective parts as closely as possible to the bearing surfaces to achieve strong magnetic forces (col.4, lines 47-56).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to position the one or more magnets in the spherical head of Bertram in view of Hyde in view of Komistek as closely as possible to the convex surface as taught by Janssen in order to achieve strong magnetic forces. While Janssen does not disclose a specific value of no more than about 5 mm, Janssen discloses the general conditions of the claim, namely a minimal distance to the spherical surface, and discloses distance to the spherical surface is a result effective variable since it affects the magnetic force. Janssen generally teaches minimizing the distance to the spherical surface of the spherical head and since it has been held that it is not inventive to discover the optimum or workable ranges by routine experimentation and would be an obvious extension of prior art teachings (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A), it would have been obvious to a person of ordinary skill in the art to select a distance of no more than about 5 mm because doing so based on the teachings of minimizing the distance of the magnet to the spherical surface as taught by Janssen involves only routine skill in the art and yields predictable results.
Regarding claims 5, 6, 10, and 15, the array taught by Hyde consists of 6 magnets around the central magnet. The magnets in the array are equidistant from each other (Hyde figs.1A, and 2A show the equal distance), and the magnets comprise a cylindrical shape (Hyde fig.1A).
Regarding claim 7, Bertram fig.6 shows the long axis of the single central magnet is perpendicular to a tangent line of the curvature at the central dome.
Regarding claim 16, Bertram fig.6 shows each magnet surrounding the central magnet having a long axis that is angled about 20 to 70 degrees from the long axis of the single central magnet and shows each magnet is perpendicular to a tangent line of the curvature of the acetabular component. Bertram teaches the magnets are oriented this way for the purpose of achieving the greatest flux density between the opposing poles of the magnets on the femoral and acetabular sides as the femoral component rotates (par.27). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to orient the acetabular component magnets of the prosthesis of Bertram in view of Hyde in view of Komistek in view of Janssen as claimed and as taught by Bertram in order to provide sufficient magnetic force for preventing dislocation and uncoupling of the components.
Regarding claims 27 and 32, Bertram shows a single magnet 604 at the end surface of the tapered volume in fig.6. The long axis of magnet 604 is perpendicular to the end surface of the tapered volume.
Regarding claim 60, Bertram discloses implanting the prosthesis in the subject in fig.6 therefore it would be obvious to implant the prosthesis of Bertram in view of Hyde in view of Komistek in view of Janssen in a subject in order to treat a subject in need of hip repair.
Conclusion
THIS ACTION IS MADE FINAL. 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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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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.
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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