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.
Claims 1-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Struck et al. (US 11534307 B2) (hereon referred to as Struck).
Regarding claim 1, Struck teaches a spinal interbody device (see Fig. 2A) comprising:
an interbody (200); and
a movable backout prevention mechanism (250) disposed at least partially within the interbody (see Fig. 2D),
comprising a body (252) and one or more lobes (256, 258) integral with the body,
wherein each of the one or more lobes (256, 258) is configured to be moved between an unlocked position for insertion of a fixation member and a locked position for preventing backout of the fixation member (see Col. 12, ll. 51-67).
Regarding claim 2, Struck teaches the device of claim 1, wherein the backout prevention mechanism (250) is configured to be rotatably moved between the unlocked position and the locked position (see Col. 12, ll. 26-50).
Regarding claim 3, Struck teaches the device of claim 1, wherein the backout prevention mechanism (250) comprises a detent (263A) configured to engage an indent (292A) to provide tactile feedback to a user and to prevent free rotation of the backout prevention mechanism (see Col. 12, ll. 56-67).
Regarding claim 4, Struck teaches the device of claim 1, wherein at least a portion of the backout prevention mechanism (250) is disposed between an anterior face of an anterior wall of the interbody and a posterior face of the anterior wall (see labeled diagram of Fig. 2C below).
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Regarding claim 5, Struck teaches the device of claim 1, wherein the body has a shape that is polyhedral (see Fig. 2A).
Regarding claim 6, Struck teaches the device of claim 1, wherein the device is manufactured using additive manufacturing (see Col. 2, ll. 43-60).
Regarding claim 7, Struck teaches the device of claim 1, wherein the device comprises titanium, tantalum, stainless steel, cobalt chrome molybdenum, or a plastic (see Col. 23, ll. 47-67).
Regarding claim 8, Struck teaches a spinal interbody device kit (see Fig. 2A) comprising:
a spinal interbody device (see Fig. 1A) comprising:
an interbody (200); and
a movable backout prevention mechanism (250) disposed at least partially within the interbody (see Fig. 2D),
comprising a body (252) and one or more lobes (256, 258) integral with the body,
wherein each of the one or more lobes (256, 258) is configured to be moved between an unlocked position for insertion of a fixation member and a locked position for preventing backout of the fixation member (see Col. 12, ll. 51-67); and
one or more tools (1300) to manipulate the backout prevention mechanism (see Col. 24, ll. 4-16 and Col. 12, ll. 4-10).
Regarding claim 9, Struck teaches the kit of claim 8, wherein the backout prevention mechanism (250) is configured to be rotatably moved between the unlocked position and the locked position (see Col. 12, ll. 26-50).
Regarding claim 10, Struck teaches the kit of claim 8, wherein the backout prevention mechanism (250) comprises a detent (263A) configured to engage an indent (292A) to provide tactile feedback to a user and to prevent free rotation of the backout prevention mechanism (see Col. 11, ll. 52-59 and Col. 12, ll. 4-10).
Regarding claim 11, Struck teaches the kit of claim 8, wherein at least a portion of the backout prevention mechanism (250) is disposed between an anterior face of an anterior wall of the interbody and a posterior face of the anterior wall (see labelled diagram of Fig. 2C above).
Regarding claim 12, Struck teaches the kit of claim 8, wherein the body has a shape that is polyhedral (see Fig. 2A).
Regarding claim 13, Struck teaches the kit of claim 8, wherein the device is manufactured using additive manufacturing (see Col. 2, ll. 43-60).
Regarding claim 14, Struck teaches the kit of claim 8, wherein the device comprises titanium, tantalum, stainless steel, cobalt chrome molybdenum, or a plastic (see Col. 23, ll. 47-67).
Regarding claim 15, Struck teaches a method of using a spinal interbody device (see Col. 26, ll. 53-64) comprising:
providing a patient in need of implantation of a spinal interbody (see Col. 25, ll. 56-67 and Col. 26, ll. 1-15);
providing the spinal interbody device (see Fig. 2A), comprising:
an interbody (200); and
a movable backout prevention mechanism (250) disposed at least partially within the interbody (see Fig. 2D),
comprising a body (252) and one or more lobes (256, 258) integral with the body,
wherein each of the one or more lobes (256, 258) is configured to be moved between an unlocked position for insertion of a fixation member and a locked position for preventing backout of the fixation member (see Col. 12, ll. 51-67); and
implanting the spinal interbody device in the patient (see Col. 25, ll. 56-67 and Col. 26, ll. 1-15).
Regarding claim 16, Struck teaches the method of claim 15, wherein the one or more lobes (256, 258) are each configured to be rotatably moved between the unlocked position and the locked position (see Col. 12, ll. 26-50).
Regarding claim 17, Struck teaches the method of claim 15, wherein the backout prevention mechanism (250) comprises a detent (263A) configured to engage an indent (292A) to provide tactile feedback to a user and to prevent free rotation of the backout prevention mechanism (see Col. 11, ll. 52-59 and Col. 12, ll. 4-10).
Regarding claim 18, Struck teaches the method of claim 15, wherein at least a portion of the backout prevention mechanism (250) is disposed between an anterior face of an anterior wall of the interbody and a posterior face of the anterior wall (see labelled diagram of Fig. 2C above).
Regarding claim 19, Struck teaches the method of claim 15, wherein the body has a shape that is polyhedral (see Fig. 2A).
Regarding claim 20, Struck teaches the method of claim 15, wherein the device is manufactured using additive manufacturing (see Col. 2, ll. 43-60).
Regarding claim 21, Struck teaches the method of claim 15, wherein the device comprises titanium, tantalum, stainless steel, cobalt chrome molybdenum, or a plastic (see Col. 23, ll. 47-67).
Regarding claim 22, Struck teaches a method for additive manufacturing of a spinal interbody device (see Col. 25, ll. 56-67 and Col. 26, ll. 1-15) comprising:
using additive manufacturing to make the spinal interbody device (see Col. 2, ll. 43-60), comprising:
an interbody (200); and
a movable backout prevention mechanism (250) disposed at least partially within the interbody (see Fig. 2D),
comprising a body (252) and one or more lobes (256, 258) integral with the body,
wherein each of the one or more lobes (256, 258) is configured to be moved between an unlocked position for insertion of a fixation member and a locked position for preventing backout of the fixation member (see Col. 12, ll. 51-67); and
wherein the mechanism is additively manufactured (see Col. 2, ll. 43-60) with the backout prevention mechanism disposed at least partially within a void formed within a portion of the interbody (see Col. 22, ll. 52-67).
Regarding claim 23, Struck teaches the method of claim 22, wherein the one or more lobes (256, 258) are each configured to be rotatably moved between the unlocked position and the locked position (see Col. 12, ll. 26-50).
Regarding claim 24, Struck teaches the method of claim 22, wherein the backout prevention mechanism (250) comprises a detent (263A) configured to engage an indent (292A) to provide tactile feedback to a user and to prevent free rotation of the backout prevention mechanism (see Col. 11, ll. 52-59 and Col. 12, ll. 4-10).
Regarding claim 25, Struck teaches the method of claim 22, wherein the at least a portion of the backout prevention mechanism (250) is disposed between an anterior face of an anterior wall of the interbody and a posterior face of the anterior wall (see labelled diagram of Fig. 2C above).
Regarding claim 26, Struck teaches the method of claim 22, wherein the body has a shape that is polyhedral (see Fig. 2A).
Regarding claim 27, Struck teaches the method of claim 22, wherein the device comprises titanium, tantalum, stainless steel, cobalt chrome molybdenum, or a plastic (see Col. 23, ll. 47-67).
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 HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773