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 .
Information Disclosure Statement
The information disclosure statement filed 06/05/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The NPL document on the IDS filed 06/05/025 was not submitted.
Claim Objections
Claims 1 and 5 are objected to because of the following informalities:
Claim 1, line 2, insert “a” before “posterior”.
Claim 1, line 16, “the proximal end” should be “a proximal end”
Claim 1, line 17, “the distal end” should be “a distal end”
Claim 5, line 1, insert “is” after “passages”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kana et al. (US Patent No. 9114023 B2) in view of Zappacosta et al. (US Publication No. 2018/0289502 A1) and Ginn (US Publication No. 2022/0296378 A1).
Regarding Claim 1, Kana discloses a bone fusion system (300, Fig. 23), comprising:
a bone fusion device (310+320, Fig. 23, col. 8; ln. 28-37) having an anterior wall, [a] posterior wall, a first lateral wall, a second lateral wall, and a central cavity open to a superior and an inferior surface (see figure below), wherein the anterior wall has a central access port extending therethrough (location shown in figure below, in Fig. 17 Kana shows that the tool (guide rod 192) extends through an opening in the anterior plate, this opening is described as 149 (Fig. 19) and disclosed as for the passage of the guide rod and for use with the locking member (col. 7; ln. 50-53)), and at least one pair of a first bone screw passage and second bone screw passage (openings 148, see figure below) in an oblique angle around the access port through the anterior wall (see below and description of holes in col. 5; ln. 11-17), the posterior wall having a hole (340) at the midpoint of its proximal surface (Fig. 23), the hole (340) being configured to detachably receive a distal end of a rod arrangement (guide rod 192) in a fastening unit specifically configured for fixing the bone fusion device into a human or animal body (see description of analogous bore 240 in col. 8; ln. 26-27); and
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a bone screw (16) in at least one of the bone screw passages (shown in Fig. 23), wherein the bone screw comprises: an elongated shaft having a proximal region and a distal region with one or more threads disposed along the length of the distal region; a head disposed at the proximal end of the elongated shaft; and a tip disposed at the distal end of the elongated shaft (see below).
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Kana is silent to the hole 340 receiving the guide rod being a blind hole.
Zappacosta discloses an intervertebral cage in the same field of endeavor wherein a guide rod (2070) extends through a proximal plate (thorugh hole 2046) and into a distal wall of the cage (2027) in order to guide the implant into place during implantation (Fig. 131, 136) [0249]. Zappacosta discloses that the threaded hole (2026) in the distal wall of the implant (2027) which receives the guide rod can be a blind hole (“the threaded bore 2026 extends from the inner surface 2027 only partially through the anterior portion 2020 of the spacer 2002”, [0249]).
It would have been obvious to one having ordinary skill in the art before the effective filing date to make the rod receiving threaded hole 340 of Kana as a blind hole as taught by Zappacosta since this is a configuration of hole known in the art to receive a guide tool in the posterior part of an intervertebral cage.
Further, Kana is silent to the screw configuration including a proximal region that is straight and a distal region (with threads) which is tapered as well as one or more helical indentations disposed along the elongated shaft in a direction opposite to the direction of said one or more threads.
Ginn discloses bone screws (270a, Fig. 9A) in the analogous art of threaded bone fasteners which have a proximal straight region (see figure below) and a distal tapered region (279) with threads (276) [0339-0342]. The screw has at least one helical indentation (290) disposed along the shaft in a direction opposite the direction of the threads (see figure below) for the purpose of communicating with a cannulation of the screw and allowing dispersion of agents and compositions through the bone screw [0342] to promote osteosynthesis surrounding the screw [0339].
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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 bone screw taught by Kana to include a configuration including a proximal region that is straight and a distal region (with threads) which is tapered as well as being cannulated with one or more helical indentations disposed along the elongated shaft in a direction opposite to the direction of said one or more threads as taught by Ginn in order to allow for a configuration which is known in the art to predictably secure to bone and allows dispersion of agents and compositions through the bone screw to promote osseosynthesis surrounding the screw.
Regarding Claim 2, Kana further discloses the bone fusion device (310+320, Fig. 23, col. 8; ln. 28-37, Kana) is assembled from a plate member (310) and a spacer member (320) , the plate member comprising: an anterior wall, a first lateral extension (one snap member 330 which has a male protrusion (i.e. lateral wall extension) like 162 shown in Fig. 21) at one end of the anterior wall and a second lateral extension (other snap member 330 which has a male protrusion (i.e. lateral wall extension) like 162 shown in Fig. 21) at the other end of the anterior wall; and the spacer member comprising: a posterior wall, a first lateral wall at one end of the posterior wall and a second lateral wall at the other end of the posterior wall (see below).
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Regarding Claim 3, Kana further discloses the first lateral extension (snap member 330 which has a male protrusion (i.e. lateral wall extension) like 162 shown in Fig. 21) has an attachment portion (163) configured to be coupled to a corresponding attachment portion (160) in the first lateral wall (fig. 21, col. 8; ln. 5-17, Kana), and the second lateral extension (snap member 330 which has a male protrusion (i.e. lateral wall extension) like 162 shown in Fig. 21) has an attachment portion (163) configured to be coupled to a corresponding attachment portion (160) in the second lateral wall (fig. 21, col. 8; ln. 5-17, Kana).
Regarding Claim 4, Kana further discloses the first bone screw passage is angled through the anterior wall in an oblique upward direction and the second bone screw passage is angled through the anterior wall in an oblique downward direction (see figure below).
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Regarding Claim 5, Kana further discloses each of the bone screw passages also angled in an inward direction towards a vertical midline of the anterior wall along the anterior- posterior axis (shown in Fig. 13, col. 7; ln. 6-10 Kana).
Regarding Claim 6, as modified by Ginn above, the one or more helical indentations of the bone screw are disposed along the whole length of the elongated shaft (taught by Ginn, see fig. 9A, Ginn).
Regarding Claim 7, as modified by Ginn above to be a cannulated screw in order to disperse composition, the bone screw further comprises: a longitudinal bore extending through said head, said straight proximal region, and at least a proximal portion of said tapered distal region (inherent due to cannulation which intersects with helical indentations, cannulation disclosed as 286 in [0338] and fig. 9B, Ginn).
Regarding Claim 8, as modified by Ginn above to be a cannulated screw in order to disperse composition, said longitudinal bore (disclosed as 286 in [0338] and fig. 9B, Ginn ) is configured to receive a guidewire of a fastening unit [0340, Ginn].
Regarding Claim 9, the longitudinal bore (disclosed as 286 in [0338] and fig. 9B, Ginn ) is a longitudinal through-bore extending through the whole screw including the head, the elongated shaft and the tip [0338, 0340, Ginn].
Regarding Claim 10, the screw of Kana as modified by Ginn above to be a cannulated screw in order to disperse composition is disclosed above. Ginn discloses that the screw could have a plurality of slits 290 [0341], therefore one of the slits 290 could be considered the helical indentation while another can be considered a through hole extending from said longitudinal bore through a lateral surface of the shaft, said through-hole being disposed along at least a portion of the length of the shaft.
Regarding Claim 11, Kana further discloses that said tip of the bone screw is a self- drilling tip (shown in Fig. 23 of Kana as having a cutting tip).
Regarding Claim 12, both Kana and Ginn disclose that the bone screw heads have a tooling recess configured for engaging with a fastening tool (shown in Fig. 23 of Kana as star shaped recess in head of screw and also in Fig. 9A of Ginn as recess 275 [0337, Ginn]).
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