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 .
Election/Restrictions
Claims 5-10, 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species A and C, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/26/25.
Applicant's traversal is on the grounds that search and examination of the entire application can be made without serious burden to the Examiner, in particular, because the requirement did not provide appropriate explanation of the reasons for search and/or examination burden. Applicant's traversal has been carefully considered, but fails to establish error in the propriety of the present requirement for restriction and election.
Though Applicant asserts that examination of all pending claims would not pose an undue burden on the Examiner, such is not an accurate assertion in light of the disparate nature of the presently claimed subject matter as noted in the Requirement for Restriction of 11/06/2025.
Consideration of the plurality of inventions that Applicant has claimed would significantly compromise and preclude a quality examination on the merits. Furthermore, execution of a search encompassing the entirety of Applicant's species would not only constitute an undue burden on the Examiner, but consideration of the findings of such a search in accordance with the requirements of the law under 35 U.S.C. §§101,102, 103 and 112 would be unduly onerous.
Moreover, it is further noted that a comprehensive search for the presently claimed subject matter is not solely limited to a search of the classes and subclasses in which they are classified. Therefore, it is obvious that a comprehensive search of the copious amounts of patent and non-patent literature for each of the patentably distinct inventions and their permutations presently claimed would necessarily place an undue burden on the Examiner.
Therefore, for the reasons above and those made of record in the Requirement for Restriction of 11/06/2025, the restriction requirement is deemed proper and is made FINAL.
Double Patenting
The following publications have been reviewed for double patenting, no double patenting rejections are present at this time:
Application #
Patent #
Double Patenting analysis
17/430,711
12127952
No double patenting
17/294,681
12115082
No double patenting
17/294,684
12090063
No double patenting
17/294,683
12090062
No double patenting
17/841,648
n/a
n/a - Abandoned application
18/928,707
n/a
No double patenting
18/974,389
n/a
No double patenting
Claim Objections
Claims 1- 2, 11-13, 15-17, 20 are objected to because of the following informalities:
Claims 1, 2, 12, 13, 15, 16, 17, and 20, instances of “the endplate” should be “the at least one endplate” for clarity and consistency purposes.
Claim 1, line 13, “the direction” should be “a direction”.
Claim 1, line 18, “a direction” should be “the direction”.
Claim 11, lines 10-14, “superior component” should be “superior endplate”, and “inferior component” should be “inferior endplate” for clarity and consistency purposes.
Claim 16, line 13, “the direction” should be “a direction”.
Claim 16, line 18, “a direction” should be “the direction”.
Appropriate correction is required.
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 1-4, 11-13, 15, 18-19 and 21 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 “near a posterior end of the core component” in claims 1 and 15, is a relative term which renders the claim indefinite. The term “near” 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. The claim limitation “near a posterior end of the core component” will be interpreted as located closer to the posterior end of the component relative to another feature of the core component.
Dependent claims 2-4, 11-13 are rejected under 112(b) as they contain all the deficiencies of claim 1 from which they depend.
The term “substantially” in claims 2, 11, 18, 21, is a relative term which renders the claim indefinite. The term “substantially” 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. For examination purposes:
The claim limitation “substantially fully inserted” in claim 2 will be interpreted as completely or visually identifiable as fully inserted.
The claim limitation “substantially coterminus” in claim 11 will be interpreted as exactly or visually appearing as coterminus .
The claim limitation “substantially the same” in claims 18 and 21 will be interpreted as exactly the same or visually identifiable as the same.
Dependent claim 19 is rejected under 112(b) as it contain all the deficiencies of claim 18 from which it depends.
The term “generally rhomboidal” in claim 21, is a relative term which renders the claim indefinite. The term “generally” 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. For examination purposes “generally rhomboidal” will be interpreted as being a quadrilateral with opposite parallel and congruent sides and angles.
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.
Claim(s) 1-3, 12, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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),
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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),
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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),
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the core component (115) defines the first and second recesses (190, 190) near a posterior end of the core component (the examiner notes that ‘near’ is a relative term that does not require any specific distance, the recesses are considered ‘near’ the posterior end because they are closer to the posterior end than other features such as the anterior face 120), the first and second recesses spaced apart from each other in the transverse direction (see below), and
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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].
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 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 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,
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the core component (115) defines the first and second recesses near a posterior end of the core component, the first and second recesses spaced apart from each other in the transverse direction,
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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].
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.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US Publication No. 2008/0294260 A1).
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.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gray (US Publication No. 2008/0294260 A1) in view of O’Neil et al. (US Publication No. 2007/0185578 A1).
Regarding Claim 13, Gray discloses the device as described in the rejection of claim 1 above. 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], however, Gray is silent to the posterior end of the core component bears against the first and second protrusions towards the end of the first stage of insertion and immediately before the second stage of insertion.
O’Neil discloses a mating connection between modular components in the analogous art of intervertebral implants. O’Neil shows a snap connection between a cantilevered finger (92a/b) having a projection (93a/b) and corresponding recess (96a/b) in Fig. 3A. O’Neil shows that the cantilever finger extends all the way from an attachment point adjacent the anterior end to the posterior end of the component to mate with the recesses located at the poster end of the mating component (fig. 3A).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to increase the lengths of the cantilevered fingers such that they extend to the posterior end and move the corresponding placement of the recess to be at the posterior end of the components of Gray as taught by O’Neil in order to provide an equivalent connection for the snap at a posterior location on the implant parts which is known in the art. This modified connection placement would predictably connect the core and endplate components of Gray upon full insertion of the core in between the endplates.
Allowable Subject Matter
Claim 11 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.
Claims 16-17, 20 are allowed. Claims 18-19, 21 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.
The following is a statement of reasons for the indication of allowable subject matter: No references, or reasonable combination thereof, could be found which disclose, or suggest, an oblique lateral intervertebral fusion device as set forth in Claim 16, comprising, in combination with all other claim limitations, proximal ends of the first and second fingers being attached to the endplate at first and second attachment locations respectively and towards an anterior end of the endplate, the first attachment location is spaced further in the direction of insertion from the anterior end of the endplate than the second attachment location.
Prior art which discloses proximal ends of fingers attached towards and anterior end such as Gray (US Publication No. 2008/0294260 A1) and O’Neil et al. (US Publication NO. 2007/0185578 A1) do not disclose or suggest locating these attachment locations at different relative spacing from the anterior end of the device.
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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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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/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773