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 § 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 14 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 14 recites “comprising at least one additional component selected from the group consisting of …. “the locking mechanism, the locking cap,…” However, parent Claim 12 incorporates all the limitations of Claim 1 and Claim 1 already positively recites the locking mechanism and the locking cap as part of the rod connector system. As such it is unclear how these items can be an additional component or if applicant is claiming an additional locking mechanism and locking cap. Clarification is requested and the examiner will treat with art as best understood.
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, 7-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ballard US 2013/0096617.
Regarding Claim 1, Ballard discloses a rod connector system (Fig 5) comprising:
a main body defining a first side opening configured for insertion of a primary rod therein (see Fig below), and
a tulip defining a second side opening configured for insertion of a secondary rod therein (see Fig below), the tulip being inserted into a top opening in the main body and attached to the main body above the main body (end of paragraph 33 where the tulip is connected to the main body in similar fashion as that shown in Fig 7, where the bottom of the tulip is inserted through a top opening), wherein the main body includes a locking mechanism (“set screw” engaged with threaded opening #523, paragraph 33) for retaining the primary rod at a desired position therein (paragraph 33), and wherein the tulip includes a locking cap (“setscrew” engaged with threaded portion #556, paragraph 33) for maintaining the secondary rod at a desired position therein (paragraph 33).
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Regarding Claim 4, Ballard discloses the main body further includes at least one lip (#530) configured to retain the primary rod (paragraph 33).
Regarding Claim 7, Ballard discloses the tulip includes internal helical threads (#556, paragraph 33) and the locking cap includes corresponding helical threads such that the locking cap is threadable in the tulip (paragraph 33).
Regarding Claim 8, Ballard discloses the tulip is rotatable in a first direction with respect to the main body so the first side opening of the main body is at a desired angle with respect to the second side opening of the tulip (paragraph 33).
Regarding Claim 9, Ballard discloses the main body and the tulip are rotatable with respect to one another such that the secondary rod in the tulip is parallel, perpendicular or at another angle with respect to the primary rod in the main body (end of paragraph 37, rotatable about a full 360 degrees).
Regarding Claim 10, Ballard discloses the locking mechanism for retaining the primary rod at a desired position in the main body, includes a top loading screw (“setscrew” paragraph 33 that is top loaded through threaded opening #523).
Regarding Claim 11, Ballard discloses the tulip includes at least one petal (petals #555) configured to receive a cannula or tab therein (one is able to place a cannula or a tab therein between the petals)(it is noted that the cannula or tab is only functionally recited and not part of the claimed invention).
Claim 15 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ballard US 2013/0096617.
Regarding Claim 15, Ballard discloses a method of connecting multiple spinal rods (paragraph 33) comprising attaching a main body to a primary rod (“vertebral rod” paragraph 33), attaching a locking mechanism to the main body, the locking mechanism being configured to lock the primary rod to a desired position with respect to the main body by compressing the primary rod (paragraph 33, setscrew threaded into threaded opening #523 compresses/clamps onto the primary rod),
attaching a tulip to the main body (see Fig below, paragraph 33),
placing a secondary rod (“second linear rod” paragraph 33) into an opening (#553) of the tulip (see Fig below, paragraph 33),
adjusting the tulip or the secondary rod, such that the secondary rod has a desired angle with respect to the primary rod, and driving a locking cap into the tulip to lock the secondary rod at a desired position (paragraph 33, end of paragraph 37 where the tulip is rotated to a desired position).
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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.
Claim 20 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 Ballard US 2013/0096617.
Regarding Claim 20, Ballard discloses the method is an open or minimally invasive method (open or minimally invasive are the only two options available for surgery and thus Ballard would fall inherently employ either an open or minimally invasive method).
In the alternative, Ballard discloses the claimed invention as discussed above but is silent as to the type of method employed, open or minimally invasive.
However, since there are only two types of surgery, open (more invasive) and minimally invasive, it would have been obvious to one of ordinary skill in the art at a time before the effective filing date of the claimed invention to modify the method of Ballard to employ an open or minimally invasive method since these are one of two finite options one can choose to carry out the method of Ballard. See also MPEP 2145.05 (II)(B).
Claims 2-3, 13 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard US 2013/0096617 in view of Hua US 2022/0409246.
Ballard discloses the claimed invention as discussed above but does not disclose a cannula detachably attached to the tulip, wherein the cannula comprises at least two tabs defining a channel therebetween.
Hua discloses a cannula (#500) detachably attached to the tulip (#504, Fig 15, paragraph 104), wherein the cannula comprises at least two tabs (#512, #512) defining a channel (Fig 15) therebetween to help guide a rod into the tulip (paragraph 104).
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 system of Ballard to include a cannula in view of Hua above because the cannula helps guide the secondary rod to the tulip.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard US 2013/0096617 in view of Nakai US 2021/0298798.
Ballard discloses the claimed invention as discussed above but does not disclose at least one lip configured to retain the primary rod, the at least one lip is configured to provide an audible or palpable confirmation of primary rod engagement to a desired location within the main body.
Nakai discloses a main body (#32, Fig 1, 3) defining a first side opening configured for insertion of a primary rod (Fig 5 where primary rod #150 is located in the first side opening), at least one lip (#70, Fig 1, 3) configured to retain the primary rod (paragraph 58), the at least one lip is configured to provide an audible or palpable confirmation of primary rod engagement to a desired location within the main body (paragraph 58, the lips provides a snap fit with the primary rod such that it will provide palpable or tactile feedback), the lip providing provisional locking with the primary rod prior to locking of the main body to the primary rod (paragraph 58).
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 main body of Ballard to include at least one lip in view of Nakai in order to provide provisional locking with the primary rod prior to locking of the main body to the primary rod.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard US 2013/0096617 in view of Nakai US 2021/0298798.
Ballard discloses the claimed invention as discussed above but does not disclose a relaxation slot at an end of a helical cut out in the main body configured to facilitate capture or placement of the primary rod in the main body.
Nakai discloses a main body (#32, Fig 1, 3) defining a first side opening configured for insertion of a primary rod (Fig 5 where primary rod #150 is located in the first side opening), a relaxation slot (see Fig below) at an end of a helical cut out in the main body (see Fig below where the cut out is curved) configured to facilitate capture or placement of the primary rod in the main body (paragraph 58, where the relaxation slot and helical cut out help define flexible lip #70 which provides provisional locking of the primary rod).
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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 main body of Ballard to include a relaxation slot at an end of a helical cut to define a flexible lip in view of Nakai above because this provides provisional locking with the primary rod prior to locking of the main body to the primary rod.
Claims 12, 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard US 2013/0096617 in view of Stein US 2017/20170348026.
Regarding Claim 12, Ballard discloses a system (Fig 5) including the main body and the tulip of claim 1 (see rejection for claim 1 above).
Ballard does not disclose the system as part of a kit.
Stein discloses a system (Fig 3) with a main body (Fig 3) with a first side opening (#42) and a tulip (#12) that is part of a kit, where the kit is provided with different sizes for the main body and suitable tools for implantation (paragraph 38).
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 system of Ballard to be part of a kit in view of Stein because the kit provides different sizes for the main body and suitable tools for implantation.
Regarding Claim 14, Ballard as modified discloses at least one additional component selected from the group consisting of instructions for use of the system, at least one of the primary rod or the secondary rod, the locking mechanism, the locking cap (paragraph 33 in Ballard where there is at least a primary rod, secondary rod and setscrews that make up the locking mechanism and locking cap), and a tool for assembly or insertion of the rod connector system or a component thereof (see also paragraph 38 in Stein).
Claims 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard US 2013/0096617 and Stein US 2017/20170348026, as applied to claim 12 above and in further view of Hua US 2022/0409246.
Ballard as modified discloses the claimed invention as discussed above but does not disclose a cannula or one or more tabs configured to form a cannula upon attachment to the tulip.
Hua discloses a cannula (#500) detachably attached to the tulip (#504, Fig 15, paragraph 104), wherein the cannula comprises at least two tabs (#512, #512) defining a channel (Fig 15) therebetween to help guide a rod into the tulip (paragraph 104).
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 kit of Ballard as modified to include a cannula in view of Hua above because the cannula helps guide the secondary rod to the tulip.
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ballard US 2013/0096617 in view of Hua US 2022/0409246.
Ballard discloses the claimed invention as discussed above but does not disclose attaching a cannula to the tulip configured to be suitable for inserting or guiding the locking cap to the tulip, wherein the cannula comprises one or more tabs that are configured to be detachable from each other and detachable from the tulip, comprising detaching the tabs from each other and from the tulip.
Hua discloses attaching a cannula (#500, Fig 15-16, paragraph 105) to a tulip (#504, Fig 15, paragraph 103) configured to be suitable for inserting or guiding the locking cap to the tulip (paragraph 105, Figs 15-16 where the cannula guides a rod to the tulip, where the cannula would be suitable for inserting or guiding a locking cap onto the tulip to secure the rod)(examiner notes that this limitation is intended use and not an actual step being claimed), wherein the cannula comprises one or more tabs (#512, #512) that are configured to be detachable from each other and detachable from the tulip (Fig 15, paragraph 104 the tabs are able to be detached from the tulip and thus from each other, likewise see Fig 15, paragraph 105 where a removable connector #530 can be included and thus removal of the connector #530 would also detach the tabs from each other), comprising detaching the tabs from each other and from the tulip (paragraph 104-105 and discussed above), the cannula helping to guide a rod into the tulip (paragraph 104-105).
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 Barrus to include the step of attaching a cannula as discussed above in view of Hua above because the cannula helps to guide the secondary rod into the tulip. As discussed above, the cannula is also suitable for guiding the locking cap after the secondary rod is received into the tulip.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard US 2013/0096617 in view of Whipple US 9,451,994.
Ballard discloses the claimed invention as discussed above but does not disclose attaching the secondary rod to a pedicle screw.
Whipple discloses a tulip (#114) attached to a main body (#16, Fig 3), a secondary rod (#102) coupled to the tulip (Fig 3, 10) and where the secondary rod (#102) is attached to a pedicle screw (#300, Fig 10) to allow the construct to be extended from a primary rod (#101) and secure the secondary rod to the spine (Col 5 lines 50-65).
It would have been obvious to one having ordinary skill in the art at a time before the effective filing date to modify the method of Ballard to include attaching the secondary rod to a pedicle screw in view of Whipple because this extends the construct and secures the secondary rod to the spine.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for other rod connector systems.
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.
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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