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 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 head of a bone screw therein (shown in Fig. 14 below);
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 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 head of a bone screw therein [“The central opening 176 may be configured to accept a portion of a fastener, such as a screw head.”, 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 proximal slotted proximal opening (170) in an upper portion of the body of the primary connector (shown below), the proximal slotted opening 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 proximally 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 proximally from the extending arm (shown below), 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].
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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) coming off of the proximal side of the extending arm integrally attached to the primary connector which is 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.
Allowable Subject Matter
Claim 19 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. The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Loftis et al. (US Publication No. 2020/0367939 A1). Although Loftis et al. (US Publication No. 2020/0367939 A1) teaches an identical secondary connector in Fig. 18 to what is claimed in claims 15, 18 and 19 (see comparison images below), there is no disclosure of this secondary connector being used with a primary connector having the limitations recited in claim 15.
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Response to Arguments
Applicant's arguments filed 7/2/26 with regards to the rejection of claim 1 as anticipated by Rayon have been fully considered but they are not persuasive. Applicant argues that the distal opening of Rayon is not configured to receive a head of a bone screw. This is not persuasive because as shown above in Fig. 14 of Rayon, there is a bone screw in the opening. This is also described in col. 6; ln. 5-32 where Rayon discloses that the connector 76 can be implanted as part of a pedicle screw.
Applicant argues with regards to the 103 rejection using Morris that Morris does not teach a single combination having a screw-head receiving tulip structure as shown in Fig. 9 and a spherical head connection as shown in Fig. 21 and the examiner has not provided a reason why PHOSITA would replace the existing integral connection of Fig. 9 with the modular spherical head shown in Fig. 21. This is not persuasive because the reasoning had been provided in the rejection where Morris discloses the modular spherical head connection allows different orientations of the rods relative to one another [0111, Morris]. This is the motivation as to why one of ordinary skill would want to use this type of connection.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant’s arguments with regards to the rejection of claim 3 are not persuasive. Applicant argues that the head 298 of the connecting member shown in Fig. 21 does not mimic a pedicle screw head. The examiner disagrees because a pedicle screw head has partially spherical outer surface as does the connector and allows for polyaxial motion of the tulip assembly as does connector 298. Therefore, in both shape and function, head 298 mimics a polyaxial screw head.
Applicant’s arguments with regards to the rejection of claim 9 are not persuasive. Applicant argues that the resultant modification of Morris does not result in distinct first tulip body and second tulip body. The examiner disagrees. As shown below, the modification made in the rejection of claim 9 relies on modifying the connection of the extending arm to the second tulip in a way which is taught by the embodiment of Fig. 21. The extending arm is already integral with the first tulip body in Fig. 9. This modification results in the connector being part of that integral extending arm (as is also shown in Fig. 21 that the head of the connector is integral with the extending arm) and now a secondary, modular tulip body which accepts that connector in order to move polyaxially to adjust the positions of the rod relative to one another.
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Applicant’s arguments towards the German reference are moot since the amendment overcame the German rejection under 35 USC 102.
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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached at 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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