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 .
Drawings
The drawings are objected to because of the following:
Figures 1-10 are not legible. They appear to be photocopies (rather than clear, black-line drawings), are dark and with poor contrast, they are illegible and fail to clearly disclose the invention as required by 37 CFR 1.84 and MPEP guidance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: “210” (see applicant’s specification, paragraph [0071].
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “215” (Figures 9-10); “22” (Figure 3); “115” (Figure 6); “315” (Figure 11).
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0071], line 4, “FIG. 6 “ should be changed to -- FIGS. 9-10 --. The description presented in paragraph [0071] is for the embodiment of Figures 9-10.
Reference number “110” has been used to identify different parts, i.e. “implant” and “serrations”.
Reference number “102” has been used to identify different parts, i.e. “serrations”, “surface architectures” and “anterior side”.
Reference number “300” has been used to identify different parts, i.e. “sagittal inclination”, “angle” and “device”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ehteshami (Pub. No.: US 2020/0197050 A1).
With regard to claim 1, Ehteshami discloses an intervertebral implant for implantation in an intervertebral space between vertebrae (see annotated Figure 4 below). The implant comprising a body 102 extending from an upper surface 110 to a lower surface 112, the body 102 having an anterior end 114, a posterior end 116, and a pair of spaced apart first and second side walls 118, 120 (see Figure 5) extending between the anterior end 114 and the posterior end 116. An internal chamber 136 is defined within the anterior and posterior ends 114, 116 and the first and second side walls 118, 120. The body 102 further includes a porous structure, i.e. multiple holes (for example holes 122, 124, 126, 132 and 134 that intersect within the body 102 to form internal chamber 136, see specification paragraph [0052]) configured to receive bone graft material. Also, the body includes other holes, e.g. 150, that received a porous structure (see specification, paragraph [0057]). As shown in annotated Figure 4, below, the upper surface 110 further comprising a plurality of upper serrations 144 positioned such that the serrations are angled and directed toward the posterior end of the body, wherein the plurality of upper serrations 144 has different heights above the upper surface (see serrations 144, on the upper surface 110, having different heights). The lower surface 112 further comprising a plurality of lower serrations 144 positioned such that the serrations are angled and directed toward the anterior end of the body, wherein the plurality of lower serrations has different heights above the lower surface (see annotated Figure 4 below).
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With regard to claim 7, the plurality of upper serrations 144 gradually increase in height along the posterior to anterior direction (e.g. annotated Figure 4, shown above, shows the posterior-most serration’s height being lower than the anterior-most serration’s height).
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.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Ehteshami (Pub. No.: US 2020/0197050 A1).
Ehteshami discloses that the plurality of upper and lower serrations may modified as appropriate for different approaches to the spine, different spinal levels, and/or different treatment modalities (see specification, paragraph [0056] and further discloses substituting serrations with barbs, teeth, spikes, or similar features.
Ehteshami discloses the claim invention except for the plurality of upper serrations gradually increasing or varying in height by 50% or greater along the posterior to anterior direction (claims 8 and 9); an anterior- most serration having a height that is at least 50% greater than the height of a posterior-most serration (claim 10); and the anterior-most serration having a height that is twice the height of the posterior-most serration (claim 11).
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Ehteshami’s serration geometry to achieve the recited height differentials. Surgeons and implant designers routinely tailor serration profiles to improve engagement with vertebral anatomy and to resist migration under anteriorly directed forces; accordingly, increasing serration height toward the anterior portion of the device is a predictable, design-driven modification. Where the general conditions of a claim are disclosed in the prior art, selecting an optimum or workable range is a matter of routine optimization within the skill of the art. See In re Aller, 220 F.2d 454, 105 USPQ 233 (CCPA 1955). Thus, implementing a 50% or greater increase in serration height in the posterior-to-anterior direction, an anterior-most serration at least 50% greater than a posterior-most serration, or an anterior-most serration twice the height of a posterior-most serration would have been within the ordinary skill of the art and would have yielded predictable results without invention.
Allowable Subject Matter
Claims 12-20 are allowed.
Claims 2-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is a statement of reasons for the indication of allowable subject matter:
The claims 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, an intervertebral implant as set forth in claims 12 and 17, wherein the upper serrations rise from the upper surface at a 45-degree angle and each of the plurality of upper serrations have different heights above the upper surface, and wherein each of the plurality of lower serrations extends from the lower surface at a 60-degree angle and are directed toward the anterior end of the body.
The claims in the instant application have not been rejected using prior art because no reference, or reasonable combination thereof, could be found which disclose, or suggest, an intervertebral implant as set forth in claims 2 and 5, wherein the plurality of lower serrations gradually increase in height along the anterior to posterior direction.
The claims in the instant application have not been rejected using prior art because no reference, or reasonable combination thereof, could be found which disclose, or suggest, an intervertebral implant as set forth in claim 3, wherein the plurality of lower serrations gradually increase in height by 50% or greater along the anterior to posterior direction.
The claims in the instant application have not been rejected using prior art because no reference, or reasonable combination thereof, could be found which disclose, or suggest, an intervertebral implant as set forth in claim 4, wherein the plurality of lower serrations have a variation of height along the anterior to posterior direction by 50% or greater.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for recited art of interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eduardo C Robert whose telephone number is (571)272-4719. The examiner can normally be reached M-F: 8 AM-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edward Lefkowitz can be reached at 571-272-2180. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773