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 .
Priority
The current claims have support going back to US Provisional 63,544,585 filed October 17, 2023.
Response to Arguments
Applicant’s arguments with respect to claim(s) below have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. New rejections were made in view of Van der Pol US 2022/0257286. It is also noted that Stein was completely reinterpreted in view of applicant’s amendments. Applicant is welcomed to contact the examiner if they have any questions.
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.
Claims 1, 4, 7, 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van der Pol US 2022/0257286 (hereinafter Van).
Regarding Claim 1, Van discloses a coupler (Fig 1a-2b) unit for use in a surgical procedure (abstract), the add on coupler unit comprising:
a receptacle portion (see Fig below) comprising:
a top (see Fig below);
a bottom disposed substantially opposite the top (see Fig below);
a first side (see Fig below);
a second side disposed substantially opposite the first side (see Fig below);
a coupler first receptacle (see Fig below) defined by internal surfaces of the receptacle portion (see Fig below), the first receptacle being configured to receive and couple to an anchor receptacle of a first coupler (it is noted that the anchor receptacle of a first coupler is functionally recited and not part of the claimed invention, where the first receptacle is capable of revieing an anchor receptacle of a first coupler, see Fig 3b):
a first opening formed in the bottom (see Fig below) and configured to allow an anchor coupled to the anchor receptacle of the first coupler to extend therethrough (it is noted that an anchor coupled to the anchor receptacle of the first coupler is functionally recited and the first opening is capable of allowing an anchor coupled to the anchor receptacle of the first coupler to extend therethrough); and
a second opening formed in the first side (see Fig below) and configured to allow a first rod coupled to the anchor receptacle of the first coupler to extend therethrough (Fig 3b, it is noted that the first rod is functionally recited and the second opening is capable of having a first rod extend therethrough), wherein the second opening is contiguous with the first opening (see Fig below); and
a rod portion extending from the second side of the receptacle portion (see Fig below), the rod portion comprising a second receptacle having a third opening (see Fig below) that is configured to receive an end portion of a second rod to thereby join the first coupler to a second coupler (Fig 3b, see Fig below, where the second rod and coupler are functionally recited and the third opening is capable of receiving an end portion of a second rod to thereby join the first coupler to a second coupler).
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Regarding Claim 4, Van discloses the coupler unit is configured to form a snap fit connection between the receptacle portion and the anchor receptacle of the first coupler, the snap fit connection requiring at least 100 pounds of force to separate (examiner notes that the first coupler is functionally recited and that the coupler unit is capable of being used with an anchor receptacle of a first coupler with deflectable features, the deflectable features deflecting inward as it is received into the first receptacle and then extends outward in snap fit when passed through the first receptacle such that it snaps onto the anchor receptacle and be made to require least 100 pounds of force to separate)(in other words, the coupler unit is capable of being coupled with an anchor receptacle of the first coupler via a snap fit, the snap fit connection requiring at least 100 pounds of force to separate).
Regarding Claim 7, Van discloses the top defines a fourth opening (see Fig below) configured to provide access to a superior portion of the anchor receptacle (see Fig below, Fig 3b where it is noted that the anchor receptacle is functionally recited and the fourth opening is capable of providing access to a superior portion of an anchor receptacle).
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Regarding Claim 8, Van discloses a rim extends between the fourth opening and the second opening (see Fig below, see Figs above in claim 1, 7).
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Claims 9-11, 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van der Pol US 2022/0257286 (hereinafter Van).
Regarding Claim 9, Van discloses a coupler system (Fig 2a-3b) comprising:
a first coupler (see Fig below, Fig 3b) comprising:
an anchor receptacle configured to receive a first anchor (see Fig below, Fig 3b-3c, able to receive a first anchor such as anchor #70, it is noted that the first anchor is only functionally recited); and
a rod of the first coupler coupled to the anchor receptacle (see Fig below, Fig 3b);
an add-on coupler (Fig 2a) configured to couple the first coupler to a second coupler (see Fig below, Fig 2a, it is noted that the second coupler is functionally recited and the add-on coupler is capable of coupling the first coupler to a second coupler via a rod #40 that is able to be coupled to the add-on coupler), the add-on coupler comprising:
a receptacle portion (Fig 2a) comprising:
a coupler receptacle receiving and coupled to the anchor receptacle (see Figs below, Fig 3b), the coupler receptacle defining a first opening allowing passage of the first anchor therethrough (see Fig below, it is noted that the first anchor is functionally recited and that a first anchor is capable of passing through the first opening, for example, the bottom of the bone anchor is capable of going through the bone anchor prior to implantation) and a second opening allowing passage of the rod of the first coupler therethrough (see Fig below); and
a rod portion (see Fog below) comprising:
a neck extending away from the coupler receptacle opposite the second opening (see Fig below); and
a rod receptacle formed in the neck, receiving and coupled to an end portion of a rod of the second coupler (see Fig below, Fig 3b, it is noted that the rod receptacle can receive a rod such as rod #40 that is able to be coupled to a second coupler).
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Regarding Claim 10, Van discloses an additional opening formed in a top thereof (see Fig above in claim 9).
Regarding Claim 11, Van discloses the first opening is contiguous with the second opening (as seen in Fig 2a above, Fig 3b).
Regarding Claim 14, Van discloses the second opening comprises a roughly u-shaped opening (as seen in Fig 2b where the second opening is roughly u-shaped).
Regarding Claim 15, Van discloses the first coupler is configured to be secured to a first spinal vertebra via the first anchor (Fig 2a-3b where the coupler is capable of being secured to the vertebra via a first anchor), and the second coupler is configured to be secured to a second spinal vertebra via a second anchor (it is noted that the second coupler and second anchor are functionally recited and looking at Fig 3b, a second coupler with a second anchor is capable of being secured to rod #40, where the second anchor is capable of securing the second coupler to a second vertebra).
Claim 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Van der Pol US 2022/0257286 (hereinafter Van).
Regarding Claim 16, Van discloses a method for forming a coupler assembly (Fig 2a, 3b) for use in a spinal procedure (abstract), the method comprising:
obtaining a coupler unit (Fig 2a) comprising:
a receptacle portion (see Fig below) comprising:
a top (see Fig below);
a bottom disposed substantially opposite the top (see Fig below);
a first side (see Fig below);
a second side disposed substantially opposite the first side (see Fig below);
a first receptacle defined by the top, the bottom, the first side, and the second side (see Fig below), the first receptacle being configured to receive and couple to an anchor receptacle of a first coupler (Fig 3b, see Fig below):
a first opening formed in the bottom that allows an anchor coupled to the anchor receptacle of the first coupler to extend therethrough (it is noted that this limitation is intended use and not an actual step, the first opening is capable of allowing an anchor coupled to the anchor receptacle of the first coupler to extend therethrough, for example, placing a distal end of the anchor through the first opening while the anchor is coupled to an anchor receptacle); and
a second opening (see Fig below) formed in the first side configured to allow a first rod (#60) coupled to the anchor receptacle of the first coupler to extend therethrough (se Fig below, Fig 3b), wherein the second opening is contiguous with the first opening (see Fig 3b, Fig below); and
a rod portion extending from the second side of the receptacle portion (see Fog below), the rod portion comprising a second receptacle having a third opening configured to receive a second rod to thereby join the first coupler to a second coupler (see Fig below, it is noted that the second coupler is not positively recited and that this limitation is intended use not an actual step, where a second coupler is capable of being coupled to second rod #40 such that the first coupler and second coupler can be coupled together);
coupling the receptacle portion of the coupler unit to the anchor receptacle of the first coupler by disposing the anchor receptacle of the first coupler therein (as seen in Fig 3b, see Fig below); and
coupling the second rod (#40) to the rod portion (Fig 3b, see fig below).
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Regarding Claim 17, Van discloses wherein the anchor receptacle of the first coupler is coupled to an existing anchor (#70) inserted into a first vertebra prior to the coupling the receptacle portion of the coupler unit to the anchor receptacle of the first coupler (abstract, paragraph 13, “already implanted”).
Claim 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stein US 2017/0348026.
Regarding Claim 16, Stein discloses a method for forming a coupler assembly (Fig 4, see also Fig 1) for use in a spinal procedure (abstract), the method comprising:
obtaining a coupler unit (Fig 1, 4) comprising:
a receptacle portion (see Fig below) comprising:
a top (see Fig below);
a bottom disposed substantially opposite the top (see Fig below);
a first side (see Fig below);
a second side disposed substantially opposite the first side (see Fig below);
a first receptacle defined by the top, the bottom, the first side, and the second side (see Fig below), the first receptacle being configured to receive and couple to an anchor receptacle of a first coupler (Fig 1, 4, see Fig below):
a first opening formed in the bottom that allows an anchor coupled to the anchor receptacle of the first coupler to extend therethrough (see Fig below, Fig 1, it is noted that this limitation is intended use and not an actual step, the first opening is capable of allowing an anchor coupled to the anchor receptacle of the first coupler to extend therethrough, for example, placing a distal end of the anchor through the first opening while the anchor is coupled to an anchor receptacle); and
a second opening (see Fig below) formed in the first side configured to allow a first rod (#50) coupled to the anchor receptacle of the first coupler to extend therethrough (se Fig below, Fig 1, 4), wherein the second opening is contiguous with the first opening (see Fig 1, Fig below); and
a rod portion extending from the second side of the receptacle portion (see Fig below, likewise paragraph 31-32, Fig 1-4 where the rod portion is able to be reoriented relative to the second opening such that it extends from the second side), the rod portion comprising a second receptacle having a third opening configured to receive a second rod to thereby join the first coupler to a second coupler (see Fig below, it is noted that the second coupler is not positively recited and that this limitation is intended use not an actual step, where a second coupler is capable of being coupled to second rod #52 such that the first coupler and second coupler can be coupled together);
coupling the receptacle portion of the coupler unit to the anchor receptacle of the first coupler by disposing the anchor receptacle of the first coupler therein (as seen in Fig 1, 4, see Fig below); and
coupling the second rod (#52) to the rod portion (Fig 1, 4, see fig below).
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Regarding Claim 17, Stein discloses wherein the anchor receptacle of the first coupler is coupled to an existing anchor (#3, Fig 1, 4) inserted into a first vertebra prior to the coupling the receptacle portion of the coupler unit to the anchor receptacle of the first coupler (paragraph 34, “previously implanted”).
Regarding Claim 18, Stein discloses coupling a second anchor receptacle of the second coupler to a new anchor and inserting the new anchor into a second vertebra (paragraph 34-35, likewise, see Fig 9 where an additional/second anchor receptacle of a second coupler is attached to second rod #52, with a new screw #70 implanted into a second vertebra to extend the construct).
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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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-3, 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Pol US 2022/0257286 in view of Hawkes US 2014/0114357.
Van discloses the claimed invention as discussed above where the second receptacle is configured to couple to a second rod (#40, Fig 3a-3b) but does not disclose the second receptacle is configured to provide a poly-axial coupling to the second rod, the rod portion comprises a neck having a slit formed therein, a collar slidably disposed along the neck, the collar is configured to at least partially compress the slit to decrease an inner diameter of the neck proximate the slit.
Hawkes discloses a similar coupling unit (see Fig below) the second receptacle is configured to provide a poly-axial coupling to the second rod so that the angle between the second rod and second receptacle can be adjusted (via an internal spherical collet #26, see Fig below, paragraph 65), the rod portion comprises a neck having a slit formed therein (see Fig below), a collar slidably disposed along the neck, the collar is configured to at least partially compress the slit to decrease an inner diameter of the neck proximate the slit to lock the second rod to the coupler unit (paragraph 62, 68, 78)
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It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the second receptacle to include a spherical collet, collar, slit in view of Hawkes above because this allows the angle between the second rod and the second receptacle to be adjusted and the collar and slit allows for locking of the angle and the second rod to the second receptacle.
Claim 12 are rejected under 35 U.S.C. 103 as being unpatentable over Van der Pol US 2022/0257286 in view of Le Couëdic 2018/0078286.
Van discloses the claimed invention as discussed above where the additional opening is proximate the second opening (see annotated Fig above in claim 9) but does not disclose a process disposed proximate the second opening, the process being configured to decrease a flexibility of the coupler receptacle.
Le Couëdic discloses a first coupler (#8, Fig 1c), an add-on coupler (Fig 2) which comprises a coupler receptacle (#22) to receive the first coupler in a snap fit (paragraph 55, Fig 1c), process (“rib”, paragraph 26, 55), the process being configured to decrease a flexibility of the coupler receptacle (by virtue of the rib adding additional structure to the coupler receptacle as compared to a coupler receptacle without a process/rib, where the rib/process increases the strength of the coupler receptacle), the process coupling to a corresponding groove on the first coupler to aid in coupling the first coupler to the coupler receptacle (paragraph 26, 55).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Van and include a process/rib in the coupler receptacle and a corresponding groove on the first coupler in view of Le Couëdic above because this provides a snap-fit connection to aid in coupling the first coupler to the coupler receptacle. The examiner notes that with the modification, the process would be located proximate the additional opening and thus would also be proximate (close to) to the second opening.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Van der Pol US 2022/0257286 and Le Couëdic 2018/0078286, as applied to claim 12 above, and in further view of Hawkes US 2015/0148853.
Van discloses the claimed invention as discussed above where the process increases a coupling strength of the add-on coupler with the first coupler by providing a snap fit between add-on coupler and first coupler (as discussed in claim 12 above), where the process defines a female member through which the first coupler is male member inserted therein (as discussed in claim 12 above) where a certain amount of pound force is needed to remove the add-on coupler (paragraph 26, 55) but does not disclose the process increases a coupling strength of the add-on coupler with the first coupler by at least 500 pounds.
Hawkes teaches removing a male member from a female member would require at least 500 pounds of force for removal (paragraph 50, 800 pounds of force or 1200 or more pounds of force).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Van as modified such that the process increases the coupling strength by at least 500 pounds, such as 800 or 1200 pounds, in view of Hawkes above because these provides known values to generate an interference fit between male and female members which require a high force for removal.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Stein US 2017/0348026 in view of Montello US 2010/0324599.
Stein discloses the claimed invention as discussed above where coupling the receptacle portion of coupler unit to the anchor receptacle of the first coupler comprises inserting a set screw (#54) through a top of the receptacle portion and into the anchor receptacle and securing the set screw (#54) in place (Fig 1, 4 paragraph 33), where the bottom of the set-screw engages the first rod (#50, Fig 4, paragraph 33) but does not disclose coupling the receptacle portion of coupler unit to the anchor receptacle of the first coupler comprises inserting a rivet through a top of the receptacle portion and into the anchor receptacle and securing the rivet in place.
Montello discloses an anchor receptacle (Fig 4a), a set screw (#64), the bottom of the set screw includes a saddle (#66) coupled to the set screw via a rivet (#80, paragraph 51, Figs 5a-5c), the saddle provides a rod contacting surface (#76) that matches the contour of a spinal rod (#24, paragraph 50).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the set screw of Stein to include a saddle that is secured to the set screw via a rivet in view of Montello above because this provides a rod contacting surface that matches the contour of the spinal rod. The examiner notes that with the addition of the saddle and rivet, Stein as modified discloses the coupling the coupler receptacle of the add-on coupler to the anchor receptacle of the first coupler comprises inserting a rivet into the coupler receptacle and the anchor receptacle and securing the rivet in place (Fig 1-4 of Stein, set screw #54 of Stein as modified to include the saddle and rivet in view of Montello is inserted into the coupler receptacle and the anchor receptacle, where tightening of nut #54 secures all the components including the rivet in place, paragraph 33 in Stein).
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Van der Pol US 2022/0257286.
Regarding Claim 18, Van discloses coupling a second anchor receptacle of the second coupler to a new anchor and inserting the new anchor into a second vertebra (paragraph 34, 45, where an additional/second anchor receptacle of a second coupler #80 is attached to second rod #40, with a new screw #70 implanted into a second vertebra to lengthen the construct).
In the alternate, Van discloses the claimed invention as discussed above where the second rod (#40) extends the construct (paragraph 34, 45) but does not explicitly disclose coupling a second anchor receptacle of the second coupler to a new anchor and inserting the new anchor into a second vertebra.
However, since the second rod (#40) is for extending the construct (paragraph 45) and that additional couplers (similar to #80) and anchors (similar #70) are used (paragraph 45), it would be obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify Van and include a second anchor receptacle of a second rod coupler (similar to #80) and a new anchor (similar #70) and inserting the new into a second vertebra as this allows the second rod to extend the construct (paragraph 34, 45).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Stein US 2017/0348026 in view of Sweeny US 2005/0107789 and Lindquist US 2013/0072983.
Stein discloses the claimed invention as discussed above where the coupling the coupler receptacle of the coupler unit to the anchor receptacle comprises implanting the coupler unit and coupling the coupler receptacle of the coupler unit to the anchor receptacle (paragraph 34), where coupling the second receptacle of the coupler unit to the rod of second coupler comprises sliding a locking component (#56) along the rod portion (paragraph 32, Fig 4, locking unit is rotatably slides along a vertical axis of the rod portion to couple the second rod #52 to the second receptacle)(it is also noted that the locking unit #56 is in the form of a set screw with an opening, where ‘56’ is placed in fig 4, for a tool).
Stein does not disclose wherein: the coupling the coupler receptacle of the coupler unit to the anchor receptacle of the first coupler comprises using an anchor locker comprising a hollow shaft configured to be disposed over a wand; and the coupling the second receptacle of the coupler unit to the rod of the second coupler comprises using a rod locker comprising a handle and a head configured to slide a locking component along the rod portion in response to actuation of the handle.
Sweeney discloses a method (Fig 4) of implanting a coupler (#10) comprising using an anchor locker (#100) comprising a hollow shaft (Fig 4, the locker itself defines a hollow shaft)(alternatively, #120 can be considered a hollow shaft) configured to be disposed over a wand (it is noted that the wand is only functionally recited and that the hollow shaft is capable of being disposed over a wand, likewise, see paragraph 29 where the hollow shaft can be disposed over a wand in the form of a dilator), the anchor locker used to retract tissue and provide a pathway to implant the coupler (paragraph 29).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the method of Stein to use an anchor locker in view of Sweeney above because this provides a pathway to implant the coupler unit to the first coupler. The examiner notes that with the modification, the anchor locker provides the necessary space/pathway for implanting the coupler unit such that the coupler receptacle of the coupler unit can coupler to the anchor receptacle of the first coupler.
Lindquist discloses coupling a rod receptacle (where rod #34 is located in Fig 11b) of a coupler unit (#10, Fig 1a, 11b) to a rod (#34) by using a rod locker (#120, Fig 11c) comprising a handle (#54) and a head (#56) configured to slide a locking component (set screw #36, where head #56 is placed within a opening of the locking component/set screw #36, Fig 11b) along the coupler unit (paragraph 96-97, Fig 11b, where the locking component #36 rotatably slides along a vertical axis of the coupler unit) in response to actuation of the handle (paragraph 96-97 via rotation of the handle).
It would have also been obvious to one having ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the method of Ensign as modified to have coupling the rod to the rod receptacle of the add-on coupler comprises using a rod locker in view of Justis because this is a known instrument to place the rod to the rod receptacle.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JAN CHRISTOPHER L MERENE whose telephone number is (571)270-5032. The examiner can normally be reached Mon-Fri 8:30 am - 6pm EST.
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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/JAN CHRISTOPHER L MERENE/ Primary Examiner, Art Unit 3773