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 .
Claim Objections
Claims 9, 10, 17, 18 are objected to because of the following informalities:
Claim 9, line 5, “the tulip body” should be “the first tulip body”.
Claim 10, line 2, “the tulip body” should be “the first tulip body”.
Claim 17, line 2, “the body” should be “the body of the primary connector”.
Claim 18, line 2, “the opening” should be “the opening in the lower portion of the body of the secondary connector”.
Appropriate correction is required.
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.
Claim 19 is 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. Claim 19 recites “the secondary connector further comprises a secondary body portion laterally offset from the body” (emphasis added). However, it is unclear if “the body” is referring to the body of the primary connector or the secondary connector (recited in claim 15). The specification provides support for both bodies of the primary and secondary connectors being laterally offset to a secondary body portion (shown in Fig. 5), therefore it is unclear from the specification which way this limitation should be interpreted. For examination purposes, “the secondary connector further comprises a secondary body portion laterally offset from the body” will be interpreted as “the secondary connector further comprises a secondary body portion laterally offset from the body of the secondary connector”.
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.
(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.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rayon et al. (US Patent No. 8758411 B1).
Regarding Claim 1, Rayon discloses a spinal connector device (70, Fig. 11), comprising: a body, comprising:
an opening formed in a distal end of the body, the opening configured to receive a portion of a fastener therein;
a slotted opening formed along a proximal portion of the body, the slotted opening configured to receive a spinal fixation rod therein;
an extending arm integrally extending from the body; and
a coupling member integrally extending from the extending arm, wherein the coupling member is configured to be received within a body of a separate spinal connector device (col. 6; ln. 5-32).
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Regarding Claim 2, the coupling member comprises an at least substantially spherical coupling head (74) (col. 6; ln. 31).
Regarding Claim 3, the coupling member is fully capable of mimicking a pedicle screw head (sphere head 74 is the same shape as a spherical head of a pedicle screw).
Claim(s) 15, 17, 18, 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by German et al. (US Publication No. 2020/0367939 A1).
Regarding Claim 15, German discloses a spinal connector system (Fig. 4), comprising: a primary connector, comprising: a body defining a slotted opening configured to receive a rod therein; an opening formed in a lower portion of the body, the opening configured to receive a portion of a bone fastener therein; an extending arm extending from an outer surface of the body; and a coupling member extending from the extending arm; and a secondary connector, comprising: a body; and an opening formed in a lower portion of the body, the opening configured to receive the coupling member therein to secure the primary connector to the secondary connector. (see figure below)
Regarding Claim 17, the arm is integral with the body of the primary connector (Fig. 2).
Regarding Claim 18, the secondary connector further comprises a proximal opening positioned above the opening (see figure below).
Regarding Claim 19 (as best understood), the secondary connector further comprises a secondary body portion laterally offset from the body [of the secondary connector], wherein the secondary body portion comprises a slotted opening configured to receive a rod therein (see figure below).
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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) 1-3, 9-18, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al. (US Publication No. 2022/0354546 A1).
Regarding Claim 1, Morris discloses a spinal connector device (160, Fig. 9), comprising: a body (162), comprising:
an opening (176) formed in a distal end of the body, the opening configured to receive a portion of a fastener therein [0091];
a slotted opening (170) formed along a proximal portion of the body, the slotted opening configured to receive a spinal fixation rod therein [0091];
an extending arm integrally extending from the body (see below).
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Morris discloses that the extending arm connects the body to a separate spinal connector device (164), however the embodiment shown in Fig 9 does not disclose a coupling member integrally extending from the extending arm configured to be received within the body of the separate connector (164).
Morris discloses an alternative embodiment of a connector device in Fig. 21. Morris discloses this connector (290) has a body with an integral extending arm (296) extending from a distal end thereof, wherein the extending arm (296) has a coupling member (298) integrally extending from the extending arm, wherein the coupling member is configured to be received within a body of a separate spinal connector device (304) in order to receive a second rod in a variety of different orientations relative to the first rod [0111].
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 connection between the second, separate connector (164) and the extending arm of the device of Fig 9 with a coupling member (spherical head) connection as taught in the embodiment of Fig. 21-22A in order to allow the second rods received by the second body to be oriented in a variety of different orientations relative to the first rod received in the first body.
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Regarding Claim 2, the coupling member (as modified above) comprises an at least substantially spherical coupling head (see teaching of element 298 in [0111]).
Regarding Claim 3, the coupling member (spherical head as modified above) is configured to mimic a pedicle screw head [0111].
Regarding Claim 9, Morris discloses a spinal tulip connector system (160, Fig. 9), comprising:
a first tulip body (162), comprising a slotted proximal opening (170) configured to receive a spinal fixation rod therein [0091] and a distal opening (176) configured to receive a screw head therein [0091]; and
a second tulip body (164).
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Morris discloses that the extending arm connects the first tulip (162) to the second tulip (164), however the embodiment shown in Fig 9 does not disclose a coupling head integrally extending from the extending arm configured to be received within a distal opening of the body of the second tulip (164).
Morris discloses an alternative embodiment of a connector device in Fig. 21. Morris discloses this connector (290) has a body with an integral extending arm (296) extending from a distal end thereof, wherein the extending arm (296) has a coupling head (298) integrally extending from the extending arm, wherein the coupling member is configured to be received within a distal opening body of a separate spinal connector device (304) (Fig. 22A) in order to receive a second rod in a variety of different orientations relative to the first rod [0111].
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 connection between the second, separate connector (164) and the extending arm of the device of Fig 9 with an integral coupling head (spherical head) on the first tulip connected within a distal opening in the second tulip taught in the embodiment of Fig. 21-22A in order to allow the second rods received by the second body to be oriented in a variety of different orientations relative to the first rod received in the first body.
Regarding Claim 10, further comprising an extending arm integrally extending from the [first] tulip body, wherein the coupling head integrally extends from the extending arm (arm shown in figure above, also see Fig. 21 for integral connections).
Regarding Claim 11, the coupling head integrally extends at an at least substantially perpendicular angle from the extending arm (Fig. 21).
Regarding Claim 12, further comprising a bone screw comprising a bone screw head, wherein the bone screw head is configured to be received in the distal opening of the first tulip body [0091].
Regarding Claim 13, Morris is silent to the relative sizes between screw heads and the spherical head 298 of the connector. However, it would have been obvious for the head 298 to comprise a shape and size that at least substantially matches a shape and size of the bone screw head since this is one of two predicable solutions (the other being different sized heads) which would both have a reasonable expectation of success of providing polyaxial motion to the connector system.
Regarding Claim 14, the coupling head comprises a plurality of facets configured to facilitate locking of the second tulip body at a desired orientation. Fig. 21 (“The outer surface of the spherical head 298 may be threaded or a have a roughened surface, for example, to enhance engagement with the corresponding opening in the headed rod 310 or tulip assembly 304.” [0110])
Regarding Claim 15, Morris discloses a spinal connector system (160, Fig. 9), comprising:
a primary connector (162), comprising a body having a slotted proximal opening (170) configured to receive a spinal fixation rod therein [0091] and a lower opening (176) configured to receive a screw head therein [0091];
an extending arm extending from an outer surface of the body (see below); and
a secondary connector comprising a body (164).
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Morris discloses that the extending arm connects the primary connector (162) to the secondary connector (164), however the embodiment shown in Fig 9 does not disclose a coupling member integrally extending from the extending arm configured to be received within a lower opening of the body of the secondary connector (164).
Morris discloses an alternative embodiment of a connector device in Fig. 21. Morris discloses this connector (290) has a body with an integral extending arm (296) extending from a distal end thereof, wherein the extending arm (296) has a coupling head (298) integrally extending from the extending arm, wherein the coupling member is configured to be received within a distal opening body of a separate spinal connector device (304) (Fig. 22A) in order to receive a second rod in a variety of different orientations relative to the first rod [0111].
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 connection between the secondary connector (164) and the extending arm of the device of Fig 9 with an integral coupling head (spherical head) on the primary connector connected within a distal opening in the secondary connector taught in the embodiment of Fig. 21-22A in order to allow the second rods received by the second body to be oriented in a variety of different orientations relative to the first rod received in the first body.
Regarding Claim 16, the primary connector comprises a tulip connector, and wherein the secondary connector comprises a tulip connector (Fig. 9, 22A).
Regarding Claim 17, the extending arm integrally extends from the outer surface of the body [of the primary connector] (Fig. 9).
Regarding Claim 18, the secondary connector further comprises a proximal opening positioned above the opening (308 shown in Fig. 22A).
Regarding Claim 20, the secondary connector is configured to be adjustable relative to the primary connector in roll, pitch, and yaw (due to polyaxial connection as modified in claim 15).
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al. (US Publication No. 2022/0354546 A1) in further view of Kondrashov et al. (US Publication No. 2013/0123854 A1).
Regarding Claim 6, Morris discloses the spinal connector device as described in the rejection of claim 1 above. However, Morris is silent to a second extending arm integrally extending from the body.
Kondrashov discloses a spinal connector (302, Fig. 3) in the same field of endeavor wherein the body of the rod receiver (301) has a first and second separate spinal connector devices ((312, 318) extending from opposite sides the body in order to provide three rods to the spinal construct which provides more support to an extremely unstable spine [0053]. Kondrashov further discloses that the separate spinal connector devices (312, 318) may be moveably connected to the first (central) rod receiver (301) to allow a surgeon to adjust the supporting rods [0055].
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 connector device of Morris to have a second spinal connector extending on an opposite side of the body as taught by Kondrashov in order to provide three rods to the spinal construct which provides more support to an extremely unstable spine. It would have been obvious to use the same structure of the extending arm and coupling member for a receiver as taught by Morris in the structure of the second spinal connector.
Therefore, regarding claim 7, the resultant device would have a second coupling member integrally extending from the second extending arm (structure taught by Morris), wherein the second coupling member is configured to be received within a body of a separate spinal connector device. And, regarding claim 8, the second extending arm extends from an opposite surface of the body relative to the extending arm (orientation taught by Kondrashov).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al. (US Publication No. 2022/0354546 A1) in further view of Jackson et al. (US Publication No. 2022/0061892 A1).
Regarding Claim 4, Morris discloses the spinal connector device as described in the rejection of claim 1 above. However, Morris is silent to the coupling member defines an at least substantially cylindrical lateral surface.
Jackson discloses a head shape for fitting into a receiver of a tulip, wherein the head shape has a cylindrical lateral surface (34) for the purpose of providing a capture recess to allow the head and retainer (70) to fit within a seating surface (132) of the tulip to avoid high-stress discontinuities while providing for a smooth continuous engagement between the internal components that resists pull-out at all angulation angles [0155].
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 shape of the coupling member (spherical head of Morris) to have a cylindrical lateral surface as taught by Jackson in order to use an alternative head configuration known in the art which could accommodate a retainer to sit within the tulip and allow a smooth continuous engagement between the internal components that resists pull-out at all angulation angles.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morris et al. (US Publication No. 2022/0354546 A1) in further view of Loftis et al. (US Publication No. 2023/02407242 A1).
Regarding Claim 5, Morris discloses the spinal connector device as described in the rejection of claim 1 above. However, Morris is silent to the extending arm extends below a lower end of the body defining the opening.
Loftis discloses a spinal connector in the same field of endeavor (Fig. 19A-D). Loftis discloses that the extension arm (220) connects the body (210) to the separate spinal connector device (230) in a direction along axis L2 (Fig. 19A) [0155]. Loftis discloses that the connection 220 may be straight or not straight (curved or bent) and may be tilted away for different acute angle(s) from any one, two, or three of the L1, L2, and L3 axes dependent on the need of the spinal applications [0155, 0186].
It would have been obvious to one having ordinary skill in the art to tilt /bend the extending arm of Morris in a direction away from the L2 axis in order to meet the need of the application of the stabilization system. It would have been obvious to tilt downwards in order to drop the secondary rod to meet the need of the application. Since the extending arm extends from the distal end of the body, any degree tilted downwards would result in the arm extending below the lower end of the body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773