DETAILED ACTION
This is the first office action on the merits in this application. The claims as amended July 26, 2024, are under consideration. Claims 1-26, 41-43, 49-53, and 55-57 were canceled. Claims 27-40, 44-48 and 54 are pending.
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 § 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.
Claim(s) 27-29 and 31-35 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Medical Enterprises Distribution IFU (as presented in the July 26, 2024, IDS) (MED hereafter).
Regarding claim 27, MED teaches a surgical system as at fig. 3 (page 7) and fig. 21 (page 22), comprising:
a surgical impacting tool handpiece seen at fig. 21 capable of driving impacting of bone; and
an adapter as at fig. 3 configured to extend distally from the surgical impacting tool handpiece (attachment at the cloverleaf fitting), wherein the adapter includes a mating feature (t-slot fitting) configured to releasably couple to an inferred mating element (slot) of an inferred surgical implement (for example, broach as seen at fig. 15) configured to impact bone, the mating feature (t-slot fitting) is configured to cooperate with the mating element (slot) to prevent rotation of the surgical implement (broach) relative to the adapter with the surgical implement (broach) releasably attached to the adapter (figs. 16-17), and the mating feature (t-slot fitting) is
a distally-extending protrusion (as seen in fig. 3) configured to be seated in a proximal-facing cavity (slot) of the surgical implement and having a cross-sectional shape that is rectangular (or oval; the t-shaped protrusion, as best seen at fig. 3 can be said to have a rectangular or oval cross-sectional shape, when viewed from the distal end).
Once a single alternative of the provided list is shown to be present in the prior art, no other alternative need be considered to be claim to have been met.
Regarding claim 28, the mating feature (t-slot fitting) is configured to cooperate with the inferred mating element (slot) to prevent rotation of the inferred surgical implement (broach) relative to the adapter with the surgical implement releasably attached to the adapter (as at figs. 16-17).
Regarding claim 29, the mating feature (t-slot fitting) is integrally formed with the adapter as in fig. 3.
Regarding claim 31, a proximal portion of the adapter at the proximal portion of the cloverleaf fitting is configured to be received within the surgical impacting tool handpiece as seen in fig. 21; and the mating feature (t-slot fitting) is on a distal-facing surface of the first adapter as at fig. 3.
Regarding claim 32, the system further comprises the surgical implement (broach of fig. 15).
Regarding claim 33, the adapter is configured to releasably attach to the surgical impacting tool handpiece as at fig. 21.
Regarding claim 34, as seen at the figures on page 27, the system is provided as a kit including additional elements, including at least one additional adapter (of the same or different configuration);
wherein each of the at least one additional adapters is configured to releasably attach to the surgical impacting tool handpiece (each of the demonstrated adapters includes a cloverleaf fitting for the handpiece) such that only one of the adapter and the at least one additional adapter is configured to extend distally from the surgical impacting tool handpiece at a time; and
each of the at least one additional adapters includes a second mating feature (as seen at the figs. of page 27) configured to releasably couple to an inferred second mating element of an inferred second surgical implement configured to impact bone (some hypothetical second implement), the second mating feature is configured to cooperate with the inferred second mating element to prevent rotation of the inferred second surgical implement relative to the additional adapter with the inferred second surgical implement releasably attached to the second adapter.
Regarding claim 35, the adapter is non-releasably attached to the surgical impacting tool handpiece (see figs. 21 and 22; at least when the locking collar is in the locked position).
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) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over MED.
Regarding claim 30, the limitations of claim 27 were taught by MED, as above, but MED does not teach the mating feature (t-slot fitting) being configured to releasably attach to the adapter.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the device to be capable of having parts thereof separated, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. One would have done so in order to improve ability to access portions of the device for purposes of thorough sterilization.
Claim(s) 36-40, 44-48 and 54 is/are rejected under 35 U.S.C. 103 as being unpatentable over MED in view of Muller (US 2019/0374349 A1).
Regarding claims 36-40, MED teaches the limitations of claim 27, as above, but MED fails to teach the mating feature (t-slot fitting) of the adapter being configured to releasably couple to a mating element of a second adapter instead of to the mating element of the surgical implement configured to impact bone; the mating feature of the adapter is configured to cooperate with the mating element to prevent rotation of the second adapter relative to the adapter with the second adapter releasably attached to the adapter; and the second adapter is non-releasably coupled to a surgical implement or is configured to releasably couple to a surgical implement.
Muller teaches a system for an impactor e.g. 40 (e.g. impact machine [0053]) driving an implement e.g. 2 using a multi part adapter 12/14/18 with a coupling 56 between the two parts, a coupling present at the proximal end of the first adapter portion 14, and a coupling between the second adapter 12/18 and the implement 2.Connection between the components is ‘non-releasable’ at least when in a locked configuration.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the MED device to include multiple adapters which work together in order to permit selection of various shapes and sizes of the components which make the adapters useful in particular patient anatomies and sizes. Further, it would have been obvious to utilize the MED connectors types to couple the components as a matter of selection of functionally equivalent connection devices. One would have done so in view of the Muller teaching that providing a multi component adapter is useful in providing a modular system which is useful in various surgical procedures at different joints of a patient, and which would be most capable of being minimally invasive. See various arrangements as at figs. 5A-J.
Regarding claim 44, MED teaches a surgical system, comprising:
a first adapter configured to extend distally from a surgical impacting tool handpiece configured to drive impacting of bone as taught above in rejecting claim 27. The first adapter of fig. 3 includes a first mating feature (t-slot fitting) capable of releasably coupling to a second mating element. The first mating feature is a distally-extending protrusion configured to be seated in a proximal-facing cavity of the surgical implement and having a cross-sectional shape that is ovular or rectangular as at fig. 3.
Once a single alternative of the provided list is shown to be present in the prior art, no other alternative need be considered to be claim to have been met.
MED fails to teach a second adapter configured to extend distally from the first adapter.
Muller teaches a system for an impactor e.g. 40 (e.g. impact machine [0053]) driving an implement e.g. 2 using a multi part adapter 12/14/18 with a coupling 56 between the two parts, a coupling present at the proximal end of the first adapter portion 14, and a coupling between the second adapter 12/18 and the implement 2.Connection between the components is ‘non-releasable’ at least when in a locked configuration.
It would have been obvious to one with ordinary skill in the art at the time of the invention to form the MED device to include multiple adapters which work together in order to permit selection of various shapes and sizes of the components which make the adapters useful in particular patient anatomies and sizes. Further, it would have been obvious to utilize the MED connectors types to couple the components as a matter of selection of functionally equivalent connection devices. One would have done so in view of the Muller teaching that providing a multi component adapter is useful in providing a modular system which is useful in various surgical procedures at different joints of a patient, and which would be most capable of being minimally invasive. See various arrangements as at figs. 5A-J.
Regarding claim 45, the second adapter is non-releasably coupled to a surgical implement configured to impact bone (at least when in a locked configuration).
Regarding claim 46, the system includes the surgical implement (broach of fig. 15) configured to impact bone; wherein the second adapter, as proposed, is configured to releasably couple to the surgical implement.
Regarding claim 47, the system further includes a surgical implement (broach of fig. 15) configured to impact bone; wherein the first mating feature of the first adapter is configured to releasably couple to a selected one of the surgical implement and the second adapter (in the proposed modification).
Regarding claim 48, the claim is considered to be further limiting an inferred component. Claim 44 originally teaches ‘a second mating element’ as an inferred component. The first mating feature is configured to cooperate with an inferred second mating element to prevent rotation of the second adapter relative to the first adapter with the first mating feature releasably coupled to the second mating element.
Regarding claim 54, the system further includes the surgical impacting tool handpiece (fig. 21 of MED).
Conclusion
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/DAVID W BATES/Primary Examiner, Art Unit 3799