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 .
Response to Arguments
Applicant's arguments filed 08/07/2025 have been fully considered but they are not persuasive. Applicant has argued that the prior art of Simmons fails to provide for the new limitation of the “plurality of bone anchors arranged in a manner to provide a unitary interface fin”, however upon further consideration Simmons is cited for providing this new limitation as cited in the following action. The new limitation has required a new 112(a) rejection for new matter/written description and all the previous 112(b) rejections are still present as are the objections to the drawings and specification.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the customized implant having both “a plurality of bone anchors arranged in a manner to provide a unitary interface fin” and that is set “using an implant screw such that the plurality of bone anchors is driven into and piecers a lower surface” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. The original drawings only show a fin in figures 5-11 that does not combine with the “implant screw” which is shown in Figure 17 as only cooperating with the custom implant in figures 14-19.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because:
-reference character “420” has been used to designate both the implant post in figures 5-9 and a screw in figures 17 and 19.
-reference character “410” has been used to designate both a fin in figures 5-9 and a spike in figures 14, 15, 17, and 19.
-reference characters "410" and "410a" have both been used to designate a fin.
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. 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:
Reference numeral 410 is first linked to a “fin” on page 8/paragraph [0032] but then in paragraph [0033] is linked to a “bone anchor” and in paragraph [0037] as “the implant”.
Reference numeral 420 is first linked to a “retention implant post” in page 8 but then on page 12 is linked to a “implant screw”.
Throughout the specification the numbering of paragraphs is inconsistent. Paragraph [0005] is actually 2 paragraphs, paragraph [0032] is actually 11 paragraphs. It appears the number of paragraphs need to be corrected throughout the specification so that each paragraph is numbered sequentially to maintain a clear consistency.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 2 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to recite the limitations of “a plurality of bone anchors arranged in a manner to provide a unitary interface fin” and that is set “using an implant screw such that the plurality of bone anchors is driven into and piecers a lower surface”, however the original disclosure fails to provide any support for these two features of a “fin” and the “implant screw” from being disclosed as being use in the same embodiment. The embodiments with the “fin” are shown and described in relation to figures 1-13c and the embodiments with the implant screw are shown and described in relation to figures 14-19. There is no support for the implant screw to be used with the fin. The attempt at adding a screw to the implant of Figs. 1-13c would result in the implant screw only screwing into the fin itself.
For purposes of examination any prior art that has bone anchors in unitary interface will be deemed to provide for a “Fin” configuration.
Regarding claim 2, any claim depending from a claim reciting new matter also recites new matter.
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 and 2 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 terms “maximized” and “maximizes” in claims 1 and 2 respectively are relative terms which renders the claims indefinite. The terms “maximized” and “maximizes” are not defined by the claims, 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 degree to which the surface area boarding healthy teeth that would be considered to be “maximized(s)” is unclear and indefinite. For purposes of examination any prior art that provides for creating a surface area of exposed jaw bone that is sufficient to effectively seat a dental implant between healthy teeth will be deemed to provide for the claim limitation.
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 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simmons et al. (US 2003/0232308 A1) including the full incorporation by reference of Simmons (US 6,537,069 B1, application no 09/968,228).
Regarding claim 1, Simmons ‘308 discloses a method of providing a dental implant (title and abstract, a method of providing reconstruction using a dental implant), the method comprising:
preparing an implant surface area by removing soft tissue and exposing underlying jawbone tissue such that the exposed jawbone tissue has a surface area that is maximized between bordering healthy teeth (Fig. 11/13 soft tissue overlaying element 104 is removed to expose the bone between the boarding health teeth 102/104 for placement of implant 114, paragraph [0016] disclosing the gum to match a natural interdental papillary is created and thus is part of the initial removing of the existing soft tissue over the missing tooth, regarding maximizing paragraph [0017] discloses the that the implant that is to be placed can have a wide platform that fills in between teeth and thus would be considered to maximize the surface area);
cutting a bone box having a set depth within the jawbone tissue, the bone box occupying the maximized surface area (paragraph [0036] all disclosing cutting box into the bone having shapes that including not having a round cross section and that the prepared osteotomy/bone box would occupy the maximized surface);
providing a customized implant with a surface area commiserate with the maximized surface area (paragraph [0068] disclosing the approach for the implant is customized and the implant is designed to match the site to be treated and thus the provided implant would be customized commiserate with the site), the insert having a plurality of bone anchors arranged in a manner to provide a unitary interface fin (Fig. 1/6/8 elements 18/66/84 being a plurality of bone anchors that are a unitary interface part of the implant that is inserted into the prepared bone with each side of the implant and anchors being aligned and forming a fin, such as two side fins for example in fig. 8a anchors 84 arranged along edge of 87 on near 86 are one side fin, alternatively longitudinal elements 90 having a length and width and height would also separately read on the limitation a unitary fin interface of a plurality of bone anchors);
setting the implant within the bone box using an implant screw such that the plurality of bone anchors is driven into and pierces a lower surface of the bone box (Fig. 1/2 element 22, Fig. 6 elements 62; Fig. 8a element 88 being an opening for such an element as 22, are all implant screws that are used to set the implant within the bone box site and the plurality of bone anchors Fig. 1/6/8 elements 18/66/84 are driven into and pierce the lower surface of the prepare bone box area, such as in paragraph [0037] disclosing that elements 18 are spikes that provide additional stability by tacking into the bone),
allowing the implant to osseo-integrate with the underlying jawbone tissue (paragraph [0070] disclosing the implant is to be Osseo-integrated).
Regarding claim 2, Simmons’308 further discloses preliminary steps of: creating a digital model of at least a portion of an oral cavity (paragraph [0068] lines 1-10 disclosing collecting data to of the treatment site to make a CAD model of the site); using the digital model to create a customized implant that maximizes osseointegration area (paragraph [0068] lines 8-9 using the 3-D model of the site to design the implant); using the digital model to create a guide for fashioning a bone box to receive the customized insert (Simmons ‘069, Fig. 9 element 94 is a guide formed to fashion the site for the implant to cut the bone box in column 7 lines 6-9); and positioning the guide within the oral cavity as a preliminary step to prepare the implant surface area (fig. 9 element 94 positioned within the oral cavity to transfer the shape of the implant to the site so the surgeon can cut the correct form column 7 lines 6-9).
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 MATTHEW P SAUNDERS whose telephone number is (571)270-3250. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached at (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.P.S/Examiner, Art Unit 3772 09/30/2025
/THOMAS C BARRETT/SPE, Art Unit 3799