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 12/26/25 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because it does not include a list of all patents, publications, applications, or other information submitted for consideration by the Office. U.S. patents and U.S. patent application publications must be listed in a section separately from citations of other documents. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
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, 2, 3, 4, 11, 12, 13, 15, 22 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.
The term “in proximity to” in claims 1 and 15 is a relative term which renders the claim indefinite. The term “in proximity to” 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. Applicant has amended the relative term “near” with an analogous term “in proximity to” which has the same issues. Applicant argues that the something that is half way between faces is not “in proximity to” one of the faces but does not demonstrate or explain at what degree of distance one of ordinary skill would consider a feature to be “in proximity to” one of the faces. There is no definitive metes and bounds to the term “in proximity to” which would allow one having ordinary skill in the art to understand what qualifies, or disqualifies, something as “in proximity to”. The specification does not use this terminology or describe any degree to measure what qualifies as “in proximity to”. Further, the dictionary definition of “in proximity to” being very near to (merriam-webster.com). Looking to the drawings for evidence, Fig. 3F shown below depicts the recesses as varying distances from the posterior face and there is no established scale of the drawings to which a percentage distance can be measured.
PNG
media_image1.png
499
674
media_image1.png
Greyscale
With no clear boundary of what is or is not “very near” and the drawings supporting varying distances of recesses from the posterior face, the scope of the claim cannot be ascertained. Therefore, claims 1 and 15 are indefinite. Dependent claims 2, 3, 4, 11, 12, 13, 22 are rejected under 112(b) as they contain all the deficiencies of claim 1 from which they depend.
For examination purposes, the limitation of claims 1 and 15, “the first and second recess in proximity to a posterior face of the core component” will be interpreted as “the first and second recesses are closer to a posterior face of the core component than an anterior face of the core component”.
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) 1-4, 12, 13, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US Publication No. 2008/0294260 A1).
Regarding Claim 1, Gray discloses an intervertebral fusion device (100, Fig. 2), comprising:
at least one endplate (110, 112, Fig. 2) configured to be received in an intervertebral space defined between first and second vertebrae [0037];
a core component (115, Fig. 2) configured to engage with the at least one endplate when the at least one endplate is in the intervertebral space and the core component is inserted into the intervertebral space [0043];
first and second fingers (165, 165, Fig. 3) [0050]; and
first and second recesses (190, 190, Fig. 7) [0054],
wherein a proximal end of each of the first and second fingers is attached to the endplate at or adjacent an anterior end of the endplate that first receives the core component when the core component is inserted into the intervertebral space (see below),
PNG
media_image2.png
545
704
media_image2.png
Greyscale
each of the first and second fingers extends in the direction of insertion of the core component towards a posterior end of the endplate and is unattached along its length except at its proximal end whereby the finger flexes along its length (see below),
PNG
media_image3.png
545
704
media_image3.png
Greyscale
the first and second fingers are spaced apart from each other in a transverse direction (shown below) which is orthogonal to a direction of insertion of the core component and to a direction of separation of the first and second vertebrae, the first finger defines a first protrusion (170) at a distal end thereof and the second finger defines a second protrusion (170) at a distal end thereof [0050], each protrusion protruding from the respective finger in the transverse direction (shown below),
PNG
media_image4.png
545
704
media_image4.png
Greyscale
the core component (115) defines the first and second recesses (190, 190) and a posterior face, the first and second recesses spaced apart from each other in the transverse direction (see below), and
PNG
media_image5.png
597
541
media_image5.png
Greyscale
the core component (115) bears against the first and second protrusions (170) during a first stage of insertion to flex the first and second fingers in the transverse direction, and during a second stage of insertion after the first stage of insertion the first and second protrusions are received in the first and second recesses respectively and under spring bias exerted by the first and second fingers to thereby retain the core component relative to the endplate [0050].
Gray is silent to the first and second recesses (190, 190) explicitly being closer to the posterior face of the core than an anterior face of the core.
The recesses and mating protrusions (170) act to mate to secure or limit movement of the plate relative to the core when the core is slid into the channel in the plate [0050]. The length of the detent arm (165) supporting the protrusion (170) on the endplate is directly correlated to the position of the recess (190) so that the endplate and core components can mate when assembled [0054]. One of ordinary skill in the art would have had reasonable expectation of success to make the detent arm 165 any length along the sliding connection between the core and endplate, and making the detent arm any length would have had predictable results of locking the core to the endplate when the protrusion engages the correspondingly positioned recess. Making the arm longer such that the protrusions and corresponding recesses are closer to the far ends of the elements would have been obvious to try.
Further, the length of the detent arm and therefore the corresponding position of the recess along the length of the core amounts to a mere change in dimension of the detent length and recess distance of the device of Gray. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) , the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In this case, the change of relative dimension such that the detent arm is longer and therefore the recess is closer to the posterior face of the core than the anterior face of the core would not have interrupted the functionality or changed the principle of operation or performance of the device of Gray and therefore would have been an obvious modification.
PNG
media_image6.png
491
927
media_image6.png
Greyscale
Regarding Claim 2, each of the first and second protrusions (170, 170) is located on the endplate (110/112) and each of the first and second recesses (190, 190) is located on the core component (115) whereby the first and second protrusions are received in the first and second recesses respectively when the core component is substantially fully inserted into the intervertebral space relative to the endplate [0043, 0050].
Regarding Claim 3, the intervertebral fusion device (100) comprises first and second endplates (110, 112) and the core component (115) is received between the first and second endplates when the core component is inserted into the intervertebral space (fig. 2) [0043, 0048].
Regarding Claim 4, Gray discloses the device as described in the rejection of claim 3 above. Gray further discloses that both endplates 110 and 112 couple with the core 115 with channels that have mating connections [0043] but doesn’t show the connections of plate 112 or that the core has third and fourth recesses to hold those fingers. However, it would have been obvious to one having ordinary skill in the art to connect endplate 112 in the same way as endplate 110 to the core115 (fingers 165 with protrusions 170 which mate with recesses 190) in order to secure endplate 112 to the core member in the same way that endplate 110 is secured to ensure all components of the implant are stable and secure.
Regarding Claim 12, the first and second protrusions (170, 170) protrude towards each other (fig. 3) and the core component (115) and the endplate (110) are configured such that the first and second fingers flex apart in the transverse direction during the first stage of insertion [0050].
Regarding Claim 13, Gray discloses the device as described in the rejection of claim 1 above with modified lengths of the detent arms and corresponding modified positions of the recesses to accept the protrusions of the detent arms. Gray further discloses that the core component (115) and the endplate (110) are configured such that transverse sides of the core component are received between and are adjacent the first and second fingers during the first stage of insertion of the core component to thereby guide movement of the core component relative to the endplate [0050]. The longer detent arms and recesses closer to the posterior face of the core component to accept the protrusions would result in the posterior end of the core component bearing against the first and second protrusions towards the end of the first stage of insertion and immediately before the second stage of insertion.
Regarding Claim 15, Gray discloses a method of installing an intervertebral fusion device (100, Fig. 2, 12a-c) in an intervertebral space between first and second adjacent vertebrae, the intervertebral fusion device comprising at least one endplate(110, 112), a core component(115), first and second fingers (165, 165, Fig. 3) and first and second recesses (190, 190, Fig. 7), the method comprising:
bringing the core component (115) into engagement with the endplate (110) by moving the core component relative to the endplate [0050, 0061]; and
inserting the intervertebral fusion device into the intervertebral space [0061], wherein a proximal end of each of the first and second fingers is attached to the endplate at or adjacent an anterior end of the endplate that first receives the core component when the core component is brought into engagement with the endplate [0050], each of the first and second fingers extends in a direction of insertion of the intervertebral fusion device into the intervertebral space towards a posterior end of the endplate and is unattached along its length except at its proximal end whereby the finger flexes along its length (see figures in rejection of claim 1), the first and second fingers are spaced apart from each other in a transverse direction which is orthogonal to the direction of insertion and to a direction of separation of the first and second vertebrae (see figures in rejection of claim 1), the first finger defines a first protrusion (170) at a distal end thereof and the second finger defines a second protrusion at a distal end thereof, each protrusion protruding from the respective finger in the transverse direction,
PNG
media_image4.png
545
704
media_image4.png
Greyscale
the core component (115) defines the first and second recesses (190, 190) and a posterior face, the first and second recesses spaced apart from each other in the transverse direction,
and the core component bears against the first and second protrusions during a first stage of engagement of the core component with the endplate to flex the first and second fingers in the transverse direction [0050], and during a second stage of engagement after the first stage of engagement the first and second protrusions are received in the first and second recesses respectively and under spring bias exerted by the first and second fingers to thereby retain the core component relative to the endplate [0050].
Gray is silent to the first and second recesses (190, 190) explicitly being closer to the posterior face of the core than an anterior face of the core.
The recesses and mating protrusions (170) act to mate to secure or limit movement of the plate relative to the core when the core is slid into the channel in the plate [0050]. The length of the detent arm (165) supporting the protrusion (170) on the endplate is directly correlated to the position of the recess (190) so that the endplate and core components can mate when assembled [0054]. One of ordinary skill in the art would have had reasonable expectation of success to make the detent arm 165 any length along the sliding connection between the core and endplate, and making the detent arm any length would have had predictable results of locking the core to the endplate when the protrusion engages the correspondingly positioned recess. Making the arm longer such that the protrusions and corresponding recesses are closer to the far ends of the elements would have been obvious to try.
Further, the length of the detent arm and therefore the corresponding position of the recess along the length of the core amounts to a mere change in dimension of the detent length and recess distance of the device of Gray. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984) , the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In this case, the change of relative dimension such that the detent arm is longer and therefore the recess is closer to the posterior face of the core than the anterior face of the core would not have interrupted the functionality or changed the principle of operation or performance of the device of Gray and therefore would have been an obvious modification.
PNG
media_image6.png
491
927
media_image6.png
Greyscale
Allowable Subject Matter
Claims 16-21 are allowed.
Claims 11 and 22 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 13 and 15 have been considered but are moot in view of the new grounds of rejection necessitated by amendment.
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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773
Prosecution Insights