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.
Claims 1-20 are 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 1 recites the limitation "the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end" in lines 20-22. It is unclear whether “the leading end and the trailing end” are referring to the leading end and trailing end of the endplate, or the leading end and the trailing end of the core component. For the purpose of examining the claim “the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end” will be interpreted as “the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end of the other of the core component and the endplate.”
Claim 1 recites the limitation "a desired extent of overlap" in line 27. The term “desired” in claim 1 is a relative term which renders the claim indefinite. The term “desired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 7 recites the limitation "the fingers of the ratchet and the further ratchet" in line 4. There is insufficient antecedent basis for this limitation in the claim (the fingers of the further ratchet). For the purpose of examining the claim, the “the fingers of the ratchet and the further ratchet” will be interpreted as “the finger of the ratchet and a finger of the further ratchet”.
Claim 11 recites the limitation "the direction of separation" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examining the claim, “the direction of separation” will be interpreted as “a direction of separation”.
Claim 14 recites the limitation "comprising first and second endplates" in lines 1-2. It is unclear whether two new endplates are being claimed, or if the first endplate is referring to the endplate disclosed in claim 1. For the purpose of examining the claim, “comprising first and second endplates” will be interpreted as “comprising a second endplate”.
Claim 15 recites the limitation "comprising first and second endplates" in lines 1-2. It is unclear whether two new endplates are being claimed, or if the first endplate is referring to the endplate disclosed in claim 1. For the purpose of examining the claim, “comprising first and second endplates” will be interpreted as “wherein the endplate is a first endplate, and further comprising a second endplate”.
Claim 20 recites the limitation "the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end" in lines 11-13. It is unclear whether “the leading end and the trailing end” are referring to the leading end and trailing end of the endplate, or the leading end and the trailing end of the core component. For the purpose of examining the claim “the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end” will be interpreted as “the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end of the other of the core component and the endplate.”
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 1-9, 11, 12, 14, 19 and 20, as best understood, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coppes et al. (U.S. Publication No.2010/0280617 A1; hereinafter “Coppes”).
Regarding claim 1, Coppes discloses an intervertebral fusion device (see the embodiment of Figures 41-42) comprising: an endplate (246) configured to be received in an intervertebral space defined between first and second vertebrae, the endplate having a leading end and a trailing end (see annotated Figure 41 below); a core component (238) configured to be received in the intervertebral space, the core component having a leading end and a trailing end (see annotated Figure 42 below); and at least one ratchet (240, 244), each at least one ratchet comprising a pawl (240) and a linear rack (244) defining plural recesses (defined by shoulders 248), the pawl comprised in one of the core component and the endplate (Figure 42 shows wherein the arms 240 are provided on the underside of component 238) , the linear rack (244) comprised in the other of the core component and the endplate (Figure 41), wherein the core component and the endplate are configured to engage with each other by disposing the leading end of the core component adjacent the trailing end of the endplate and then moving the core component relative to the endplate in a direction of insertion such that the leading end of the core component moves towards the leading end of the endplate and extent of overlap of the core component and the endplate increases (para.0132), the plural recesses (defined by shoulders 248) of the linear rack extend in the direction of insertion and from near or at one of the leading end and the trailing end of the other of the core component and the endplate towards the other of the leading end and the trailing end of the other of the core component and the endplate (Figures 41-42), the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end of the endplate (Figure 41 shows wherein shoulders 248 extend less than 60% of a distance between the leading end and trailing end of the endplate 246), and the at least one ratchet is configured such that the pawl starts to inter-engage with the plural recesses of the linear rack as the core component is moved further relative to the endplate in the direction of insertion and such that the pawl progresses along the plural recesses with further movement of the core component until the core component and the endplate have a desired extent of overlap (para.0132).
Regarding claim 2, Coppes further discloses wherein the pawl (240) is integrally formed with the one of the core component and the endplate (Figure 42 shows wherein arms 240 are integral with component 238), and the linear rack (244) is integrally formed with the other of the core component and the endplate (Figure 41 shows wherein channel 244 is integrally formed with endplate 246).
Regarding claims 3 and 4, Coppes further discloses a further ratchet (the second side of the ratchet disclosed in claim 1 above), the further ratchet comprising a pawl (second finger 240 in Figure 42) and a linear rack defining plural recesses (defined by second shoulder 248 in Figure 41), and the ratchet and the further ratchet are spaced apart from each other in a transverse direction (see annotated Figures 41-42 below). Coppes further discloses wherein the linear racks of the ratchet and the further ratchet are spaced apart from each other in the transverse direction and are substantially parallel to each other (recesses defines by shoulders 248 are parallel to each other, as shown in Figure 41).
Regarding claim 5, Coppes further discloses wherein the pawl comprises a finger (240) which defines at least one protrusion at a distal end of the finger (protrusions defined by shoulders 242 as shown in Figure 42), the finger attached at its proximal end at or near one of the leading end and the trailing end of the one of the core component and the endplate (see annotated Figure 42 below).
Regarding claim 6, Coppes further discloses wherein the finger extends in the direction of insertion towards the other of the leading end and the trailing end whereby the distal end of the finger is at or near the other of the leading end and the trailing end (see annotated Figure 42 below).
Regarding claim 7, Coppes further discloses a further ratchet (the second side of the ratchet disclosed in claim 1 above), the further ratchet comprising a pawl (second finger 240 in Figure 42) and a linear rack defining plural recesses (defined by second shoulder 248 in Figure 41), and the ratchet and the further ratchet are spaced apart from each other in a transverse direction (see annotated Figures 41-42 below), and in which the finger of the ratchet and a finger of the further ratchet are spaced apart from each other in the transverse direction and are substantially parallel to each other (see annotated Figure 42 below).
Regarding claim 8, Coppes further discloses wherein the at least one protrusion of the finger of the ratchet and the at least one protrusion of the finger of the further ratchet protrude towards each other, and the core component and the endplate are configured such that the fingers of the ratchet and the further ratchet flex apart in the transverse direction as the core component moves relative to the endplate in the direction of insertion (arms 240 are initially pushed resiliently together as they enter guiding portion 247 of channel 244, and eventually arms 240 spring outwards and shoulders 242 are captured by edges 248 of channel 244, see para.0132).
Regarding claim 9, Coppes further discloses wherein the core component and the endplate are configured such that transverse sides of the core component are received between and are adjacent the fingers of the ratchet and the further ratchet to thereby guide movement of the core component relative to the endplate (para.0132).
Regarding claim 11, Coppes further discloses wherein the core component and the endplate are configured to inter-engage whereby there is movement of the core component and the endplate in the direction of insertion, and movement in a direction of separation of the first and second vertebrae is prevented (arms 240 are initially pushed resiliently together as they enter guiding portion 247 of channel 244, and eventually arms 240 spring outwards and shoulders 242 are captured by edges 248 of channel 244, see para.0132).
Regarding claim 12, Coppes further discloses wherein the core component defines an elongate protrusion on each transverse side (arm 240 on each transverse side of component 238), the endplate defines a keyway towards each transverse side (keyway defined by shoulder 248 on each transverse side of component 246), and each elongate protrusion is slidably received in a respective one of the keyways (para.0132).
Regarding claim 14, Coppes further discloses a second endplate, the second endplate comprised in and integrally formed with the core component (the second endplate is the upper side of inlay 238, as shown in Figure 41).
Regarding claim 19, Coppes further discloses wherein the core component and the endplate are configured to lock together when they are in registration with each other to prevent movement in a direction of separation of the first and second vertebrae (arms 240 are initially pushed resiliently together as they enter guiding portion 247 of channel 244, and eventually arms 240 spring outwards and shoulders 242 are captured by edges 248 of channel 244, see para.0132).
Regarding claim 20, Coppes discloses a method of installing an intervertebral fusion device in an intervertebral space defined between first and second vertebrae, the intervertebral fusion device comprising an endplate (246) having a leading end and a trailing end (see annotated Figure 41 below), a core component (238) having a leading end and a trailing end (see annotated Figure 42 below), and at least one ratchet (240, 244), each at least one ratchet comprising a pawl (240) and a linear rack (244) defining plural recesses (recesses defined by shoulders 248), the pawl comprised in one of the core component and the endplate (Figures 41-42), the linear rack (244) comprised in the other of the core component and the endplate (Figures 41-42), the plural recesses extending in a direction of insertion of the intervertebral fusion device into the intervertebral space and from near or at one of the leading end and the trailing end of the other of the core component and the endplate towards the other of the leading end and the trailing end of the other of the core component and the endplate (Figures 41-42), the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end (Figure 41 shows wherein shoulders 248 extend less than 60% of a distance between the leading end and trailing end of the endplate 246), the method comprising: disposing the leading end of the core component adjacent the trailing end of the endplate (Figure 41); bringing the core component into engagement with the endplate by moving the core component relative to the endplate in the direction of insertion such that the leading end of the core component moves towards the leading end of the endplate and extent of overlap of the core component and the endplate increases (para.0132); and further moving the core component relative to the endplate in the direction of insertion whereby the pawl starts to inter-engage with the plural recesses of the linear rack and such that the pawl progresses along the plural recesses with further movement of the core component until the core component and the endplate have a desired extent of overlap (para.0132); and installing the endplate and the core component in the intervertebral space (para.0092).
PNG
media_image1.png
637
499
media_image1.png
Greyscale
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 13 is rejected under 35 U.S.C. 103 as being unpatentable over Coppes (U.S. Publication No.2010/0280617 A1).
Regarding claim 13, Coppes discloses the claimed invention except for wherein the endplate is an inferior endplate, the linear rack is comprised in the core component and the pawl is comprised in the inferior endplate. Instead, Coppes discloses wherein the linear rack (244) is comprised in the inferior endplate (246) and the pawl (240) is comprised in core component (238). 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 locking mechanism of Coppes such that the linear rack is comprised in the core component and the pawl is comprised in the inferior endplate, since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art. In re Einstein, 8 USPQ 166 (CCPA 1931).
Claims 15-18, as best understood, are rejected under 35 U.S.C. 103 as being unpatentable over a first embodiment of Coppes (Figures 1-2), in view of a second embodiment of Coppes (Figures 41-42) as applied to claim 1 above.
Regarding claim 1, Coppes discloses an intervertebral fusion device (embodiment shown in Figures 1-2) comprising: an endplate (12) configured to be received in an intervertebral space defined between first and second vertebrae, the endplate having a leading end (near reference numeral 18 in Figure 1) and a trailing end (near reference numeral 22 in Figure 1); a core component (16) configured to be received in the intervertebral space, the core component having a leading end (opposite end of reference numeral 38 in Figure 1) and a trailing end (near reference numeral 38 in Figure 1); wherein the core component and the endplate are configured to engage with each other by disposing the leading end of the core component adjacent the trailing end of the endplate and then moving the core component relative to the endplate in a direction of insertion such that the leading end of the core component moves towards the leading end of the endplate and extent of overlap of the core component and the endplate increases (para.0097).
Furthermore, regarding claims 15-18, Coppes discloses a second endplate (14), and wherein the core component (16) is configured to be received between and to engage with the first and second endplates by movement of the core component relative to the first and second endplates (para.0097). Coppes further discloses wherein transverse sides (wings 42) of the core component (16) are snugly received between opposing walls (44) defined by the second endplate whereby the core component moves slidably relative to the second endplate in the direction of insertion (para.0097).
However, Coppes’s first embodiment (Figures 1-2) fails to disclose at least one ratchet, each at least one ratchet comprising a pawl and a linear rack defining plural recesses, the pawl comprised in one of the core component and the endplate, the linear rack comprised in the other of the core component and the endplate, the plural recesses of the linear rack extend in the direction of insertion and from near or at one of the leading end and the trailing end of the other of the core component and the endplate towards the other of the leading end and the trailing end of the other of the core component and the endplate, the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end of the endplate, and the at least one ratchet is configured such that the pawl starts to inter-engage with the plural recesses of the linear rack as the core component is moved further relative to the endplate in the direction of insertion and such that the pawl progresses along the plural recesses with further movement of the core component until the core component and the endplate have a desired extent of overlap.
In a second embodiment, Coppes discloses a locking mechanism comprising at least one ratchet (240, 244), each at least one ratchet comprising a pawl (240) and a linear rack (244) defining plural recesses (defined by shoulders 248), the pawl comprised in one of the core component and the endplate (Figure 42 shows wherein the arms 240 are provided on the underside of component 238) , the linear rack (244) comprised in the other of the core component and the endplate (Figure 41), the plural recesses (defined by shoulders 248) of the linear rack extend in the direction of insertion and from near or at one of the leading end and the trailing end of the other of the core component and the endplate towards the other of the leading end and the trailing end of the other of the core component and the endplate (Figures 41-42), the plural recesses extending by no more than 60% of a distance between the leading end and the trailing end of the endplate (Figure 41 shows wherein shoulders 248 extend less than 60% of a distance between the leading end and trailing end of the endplate 246), and the at least one ratchet is configured such that the pawl starts to inter-engage with the plural recesses of the linear rack as the core component is moved further relative to the endplate in the direction of insertion and such that the pawl progresses along the plural recesses with further movement of the core component until the core component and the endplate have a desired extent of overlap (para.0132).
It would have been obvious to one of ordinary skill the art before the effective filing date of the claimed invention to modify the implant 10 of Coppes’s first embodiment (Figure 1 and 2) such that the core component and an endplate are connected via a ratchet mechanism as disclosed in Coppes’s second embodiment (Figures 41-42) in order to provide an additional means of securing the core component and endplate together.
PNG
media_image2.png
654
464
media_image2.png
Greyscale
Allowable Subject Matter
Claim 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 10 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 1. In particular, none of the cited references teach or suggest wherein the finger defines plural protrusions towards a distal end of the finger, the finger defining a first number of protrusions and the linear rack defining a second number of recesses, the second number being greater than the first number, as required by claim 10.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Baynham et al. U.S. Publication No.2007/0270968 A1
Weiman et al. U.S. Publication No.2016/0151168 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773