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 .
The current application has the priority date of 06/30/02023 to PRO 63511407
Claim Status
As per preliminary claim amendment received on 06/28/2024, claims 1-18 are pending.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9, 11, 16 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7 and 9, these claims recite “moveable, non-rigid spacer” and “moveable, non-rigid spacer receiver”; in here the term “non-rigid” is a relative term which renders the claim indefinite. The term “non-rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The Examiner suggest using other structural description from the Specification including “compressed, deformed, or retracted” found in [0055].
Regarding claim 11, the claim recites “further comprising multiple additional medical devices disposed between the first medical device and the second medical device when the medical device connection mechanism is placed in an assembled configuration” (emphasize added); the term ‘multiple additional medical devices’ as recited within the context of the claim is rejected under rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim because this can refer to any number and any type of existing medical devices.
Regarding claim 16 and 17, these claims recite the claim features, “key slot” and “keyed interrupted threaded portion”; these limitations are not defined in the claim, not are they distinctly defined in the Specification. The Applicant is encouraged to describe these terms using additional structural features found in Specification [0041-0043].
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5 and 11-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bouliane US 2013/0282019 A1 (hereinafter “Bouliane”).
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Regarding claim 1, Bouliane discloses an orthopedic medical device connection mechanism (instrument 100) comprising:
a first medical device (first shaft 118) having:
a protrusion (see annotated Fig. 5A), the protrusion including a proximal end and a distal end distally disposed from the proximal end along a height of a protrusion body (see Fig. 5A: “protrusion body” is annotated in rectangle), the protrusion body comprising an interrupted threaded portion (external treads 162, with slot 158) disposed closer to the distal end than the proximal end (see Fig. 5A); and
a second medical device (receiver 204) having:
a body (210),
an interior sidewall (see annotated Fig. 6A), the interior sidewall defining a hole extending into the body (204; Note: regarding “hole” annotated Fig.6A shows body 204 engaged with screw 202 at its distal end, but when screw 202 is removed, a through-hole in 204 would be apparent, see col.4, ll.8-22),
a discontinuous threaded portion (internal thread 214, with U-shaped channel 212) disposed within the hole, the discontinuous threaded portion defining a threadless channel extending along a discontinuous threaded portion height, and the discontinuous threaded portion configured to receive the interrupted threaded portion of the protrusion of the first medical device through the threadless channel (col.6, ll. 15-17 “The external thread 162 may include a first diameter T1 sufficient for threaded engagement with the internal thread 214 of the receiver 204”; also see Figs. 5A-6C).
Regarding claim 2, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the protrusion further comprises a shank portion disposed closer to the proximal end of the protrusion than the distal end. (see annotated Fig. 5A)
Regarding claim 3, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein threads of the interrupted threaded portion (external treads 162) and threads of the discontinuous threaded portion (internal thread 214) have a trapezoidal cross-sectional shape. (This is illustrated as shown in Figs. 5A-6C)
Regarding claim 4, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the discontinuous threaded portion (internal thread 214) defines multiple threadless channels extending along the discontinuous threaded portion height (at least two U-shaped channels 212; as shown in Fig. 6A-6C and col.4, ll.23-35).
Regarding claim 5, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the discontinuous threaded portion (internal thread 214) is configured to receive the interrupted threaded portion (external treads 162) of the protrusion of the first medical device through multiple threadless channels. (col.6, ll.6-10 “. An external male thread 162 on the distal end of the attachment feature 110 may mate with the internal female thread 214 of the receiver 204 as shown in FIG. 2. The external thread 162 may include a tapered distal surface.”)
Regarding claim 11, Bouliane discloses the orthopedic medical device connection mechanism of claim 1 further comprising multiple additional medical devices (106, 108, 120, 202) disposed between the first medical device and the second medical device when the medical device connection mechanism is placed in an assembled configuration. (As shown in Fig. 6A and 6B: screw 202, driving feature 106, alignment features 108 and shaft 120 are all taken to encompass “multiple additional medical devices” disposed between 118 and 200)
Regarding claim 12, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the first medical device (first shaft 118) is selected from the group consisting essentially of: an adaptor, a handle, and a positioning member. (See [0024-0025] first shaft 118 is adapted for screw delivery, it is taken to encompass an “adaptor” and/or a “positioning member” for a screw in this claim)
Regarding claim 13, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the second medical device (receiver 204) is selected from the group consisted essentially of: a broach, a reamer, a rasp, a keel punch, and a bone cutting device. (see [0022-0023] receiver 204 is part of screw assembly 200, and is taken to encompass “broach” or “reamer” in this claim)
Regarding claim 14, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the second medical device (receiver 204) is selected from the group consisting essentially of: an endoprosthetic cone, an endoprosthetic implant, and an endoprosthetic implant component. (See Background of invention [0003-0004]: device adapted for spine, hip, and thigh regions)
Regarding claim 15, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the second medical device (receiver 204) is a secondary adaptor configured to engage an orthopedic instrument, an orthopedic endoprosthetic implant, of a component thereof. (see [0022-0023] receiver 204 is part of screw assembly 200, which is taken to encompass “secondary adaptor” for a screw placement, and also see Background of invention [0003-0004]: device adapted for spine, hip, and thigh regions)
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 6 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bouliane as applied to claim 1 and further in view of Garcia-Bengochea et al. US 2018/0140336 A1 (hereinafter “Garcia”).
Regarding claim 6, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, but does not disclose wherein threads of the interrupted threaded portion (162) and threads of the discontinuous threaded portion (214) are timed threads. However, another prior art reference in the analogous field of orthopedic medical device connection mechanism, discloses a spinal stabilization implant assembly, comprising a first medical device (302; see Fig. 15) having a protrusion (314) comprising a threaded portion (308), and a second medical device (304; see Fig. 15) having a body, an interior sidewall defining a hole (340), a discontinuous threaded portion (350), in which second medical device is configured to receive the threaded portion of the protrusion of the first medical device (as shown in Figs. 15-16). Specifically, with regard to the coupling, the second medical device comprising a clocking connection, comprising a clocking alignment recess 362 on the second medical device, adapted to engage with the clocking alignment projection 364 on the first medical device, as described in [0096]. (Note: ‘clocking’ alignment is taken to encompass “timed” threads because these are analogous concepts in the art.) It would have been obvious to a person of ordinary skill in the art at the time of invention to modify the threads of the interrupted threaded portion (162) and threads of the discontinuous threaded portion (214) to include a timed delivery connection, i.e. via timed threads, in view of the clocking alignment in Garcia; the motivation for doing so is because this type of connection provides visual and functional alignment that is known to improve seal and gap, preventing gaps, and speeding up assembly.
Regarding claim 18, this claim is rejected by Bouliane and in view of Garcia as discussed to claims 1 and 6 above.
Claims 7-10, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bouliane as applied to claim 1 and further in view of Ainsworth et al. US 2006/0079898 A1 (hereinafter “Ainsworth”).
Regarding claims 7 and 9, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, wherein the first medical device (118) further comprises a base (stop 164, see annotated Fig. 5A: shaded area), the protrusion extends from a distal side of the base (164; see Fig. 5A-5D), but Bouliane does not disclose a moveable non-rigid spacer extends from the distal side of the base. Bouliane also discloses a proximal side of the second medical device (receiver 204), but does not disclose wherein the proximal side of the second medical device further comprises a moveable non-rigid spacer receiver.
However, Ainsworth, another prior art reference in the analogous art of spinal surgical devices discloses a bone anchor (300) comprising a distal portion 340 and a proximal portion 344 (see Fig. 4). With regard to the coupling of these two medical devices, Ainsworth discloses using of an elastically deformable component, an elastic washer/ring or a coil spring and a corresponding receiving structure/shape for said elastically deformable component ([0115-0116, 0119-0120]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Bouliane to include the elastic deformable component and corresponding receiver as part of the orthopedic medical device connection mechanism of claim 1, in view of Ainsworth; the motivation for doing so is to allow for load distribution between components. (Ainsworth [0115]).
Regarding claims 8 and 10, Bouliane in view of Ainsworth further discloses the orthopedic medical device connection mechanism of claim 7; but does not disclose a pin extending from the distal side of the base; and wherein the proximal side of the second medical device further defines an arcuate groove configured to closely receive the pin of the first medical device as a configuration of the medical device connection mechanism changes from a preassembled configuration to an assembled configuration.
However, Bouliane teaches inserting one or more guiding pins 150 to corresponding slots for maintaining alignment between an inner portion 132 and an outer portion 134 ([0029] and as shown in Fig. 4). As it is recognized in Bouliane that guiding pins can be used for alignment; it would have been a mere design choice at the time of invention to further modify Bouliane to include a guiding pin extending from the distal side of the base and to provide an arcuate groove configured to closely receive the pin of the first medical device as a configuration of the medical device connection mechanism changes from a preassembled configuration to an assembled configuration. The motivation for doing so would be for optimize alignment of the first and second medical devices.
Regarding claims 16 and 17, Bouliane discloses the orthopedic medical device connection mechanism of claim 1, but does not disclose wherein the threadless channel is a keyed slot, the keyed slot being recessed within the body of the second medical device and wherein the interrupted threaded portion of the protrusion is a keyed interrupted threaded portion.
However, Ainsworth, another prior art reference in the analogous art of spinal surgical devices discloses a bone anchor (300) comprising a distal portion 340 and a proximal portion 344 (see Fig. 4). With regard to these two medical devices, Ainsworth states in [0094] “slot 488 in the cavity (364?) of the distal bone anchor 340 and the slot 492 in the cavity 412 of the proximal bone anchor 344. The use of these two slots allows for a keyed delivery of the two components. A keyed (or timed) delivery of the two bone anchors 340 and 344 allows for control over the rotational position of the two sets of threads.” It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Bouliane’s threadless channel (U-shaped channel 212) in the second medical device (204) as a keyed slot, and the interrupted threaded portion (external treads 162) in the first medical device (118) as a keyed interrupted threaded portion, in view of Ainsworth; the motivation for doing so is because “this controlled delivery is to avoid cross threading.” (Ainsworth: [0094] increase strength and maximum engagement between the threads in counter parts.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
December 24, 2025