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 Amendment
This action is in response to Applicant’s amendment filed 3/9/26.
Response to Arguments
Applicant's arguments filed 3/9/26 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
The Examiner notes that Applicant argues that the combination of Vuillemot/Hansen does not teach the newly added limitations of the claims, however upon further consideration the Examiner disagrees, finding such limitations to fall short of overcoming the arrangement of the space as taught by Hansen. Specifically, the claim states that the spaces extend from an occlusal side to a gingival side of the mold body, without defining what said sides encompass. Accordingly, the interpretation below, namely that the top half of the device of Hansen is an occlusal side and the bottom half being a gingival side, with the space thereby extending from the occlusal to the gingival side, reads on the added claim language. Additionally, the Examiner notes several other issues that must be addressed as explained below. Therefore, Applicant’s arguments have been fully considered but are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments.
Note: In order to move the application forward, the Examiner suggests Applicant make the following changes in the claims.
Clarify that the first and second space extend completely though the gingival and occlusal sides such that they are open to the gingival and occlusal edges of the mold portions, or the like.
In view of the new grounds of rejection to Martz (see below), link the film of claim 12 back to the film of claim 1 and amend claim 1 to be a kit, or alternatively pursue the kit of claim 12.
Amend the independent claim(s) to recite a connection between in the mold portions, which must be present to hold the portions together; for example incorporating claim 11 into the independent claim
Amend the specification as required below
Specification
The disclosure is objected to because of the following informalities: While the newly added limitations to claim 1 are supported by the original figures 2-3, the terms listed in the claim are not found in the original disclosure. The claim language (and any further amendment thereto) should be added to the specification. No new matter should be entered.
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 1-9 and 11-12 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.
Regarding claim 1, the claim as a whole is indefinite as it is unclear how the tool comprising a mold body comprising distinct facial and lingual mold portions and an incisal flexure for each, with a space therebetween, is held together to form the body. As best understood by the Examiner the stiffening bar (claim 11) or other handle must be provided between the mold portions in order to hold them together to form the mold body. This position is supported by the original disclosure which shows the mold portions only being held together by the stiffening bar. As such it is unclear how the device functions as a “body” when the components are separate from each other. Clarification is required.
Regarding claim 12, the term “at least one flexible film” is indefinite as it is unclear whether or not the term intends to refer back to the previously recited film, or a separate film. As best understood by the Examiner the term is intended to refer back, however the claim should be amended to recite as such. Clarification is required.
All other claims not specifically addressed above are rejected based on their dependency on a previously rejected claim.
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.
Claim(s) 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martz et al (US 2015/0157421 A1).
Regarding claim 1, Martz et al discloses a dental restoration custom tool (see device of Figs. 2-3; configured to be used to place restorative material if so desired), comprising: a mold body (all instances of 15 in combination) for a patient-specific, customized fit with a facial side and a lingual side of at least two adjacent teeth of a patient (see Figs. 2-3 and [0008]-[0008], [0054]-[0055]), wherein the mold body comprises: a first facial mold portion (facial portion of a first instance of 15) for the patient-specific, customized fit with the facial side of a first tooth of the patient; a second facial mold portion (e.g. facial portion of an adjacent instance of 15) for the patient-specific, customized fit with the facial side of a second tooth of the patient adjacent the first tooth; a first lingual mold portion (e.g. lingual portion of the first instance of 15) for the patient-specific, customized fit with the lingual side of the first tooth of the patient; a second lingual mold portion (e.g. lingual portion of the adjacent instance of 15) for the patient-specific, customized fit with the lingual side of the second tooth of the patient (all portions capable of applying a mold material to the teeth if so desired); and a first incisal flexure including a first curved body connecting and integrally joining the first facial mold portion to the first lingual mold portion (e.g. incisal/occlusal surface of first instance of 15), and a second incisal flexure including a second curved body connecting and integrally joining the second facial mold portion to the second lingual mold portion (e.g. incisal/occlusal surface of the adjacent instance of 15), the flexures configured to allow the facial mold portions and the lingual mold portions to articulate relative to one another (e.g. at least to some degree due to flexibility of the device; see [0054]-[0055]), wherein the mold body includes a first space between the first facial mold portion and the second facial mold portion (e.g. open area between the facial surfaces of the first and adjacent instances of 15; see Figs. 2-3) and a second space between the first lingual mold portion and the second lingual mold portion (e.g. open area between the lingual surfaces of the first and adjacent instances of 15; see Figs. 2-3), wherein at least a portion of a flexible film is capable of being interposed between the first space and the second space to form an interproximal portion of a mold cavity between the first tooth and the second tooth (capable of being used as such if so desired; film not positively recited, required nor part of the claimed tool), and wherein the first space and the second space each extend from an occlusal side of the mold body to a gingival side of the mold body (see Figs. 2-3), and wherein the mold body is configured to combine with the flexible film to form the mold cavity encompassing missing tooth structure of at least one tooth of the first tooth and the second tooth (configured to be used as such if so desired; mold not positively recited, required or part of claimed tool; space is configured to receive an appropriately sized and shaped film).
Martz further discloses wherein the first and second facial portions of the mold body and the first and second lingual portions of the mold body correspond with portions of an existing tooth structure of the patient prior to restoration (e.g. can be used prior to any restoration), the mold body having a geometry selected to provide the patient-specific, customized fit based on three-dimensional (3D) scan data from a digital 3D representation or model of an intraoral structure of the patient (see citations above), the geometry being defined to accommodate an average thickness of the flexible film (e.g. appropriately sized and shaped film based on the geometry is configured to be used therewith; film not positively required, see above; per claim 2); wherein the first incisal flexure includes a first flexure surface that aligns with an incisal surface of the first tooth (e.g. occlusal/incisal surface of first instance of 15; per claim 3); wherein the second incisal flexure includes a second flexure surface that aligns with an incisal surface of the second tooth (e.g. occlusal/incisal surface of adjacent instance of 15; per claim 4); wherein one or more of the first flexure surface or the second flexure surface provides a positional reference surface for the incisal surface of either the first tooth or the second tooth (e.g. incisal/occlusal surfaces of tool provide a position reference surface as it is engaged with the incisal/occlusal surfaces; per claim 5); wherein the flexible film is configured to extend from a supragingival surface to a subgingival surface of a tooth to be restored (tool configured to be used with a film placed as such if so desired; film not positively recited, see above; per claim 6); wherein the flexible film is configured to extend between a portion of a gingiva of the patient and a subgingival surface of the tooth to be restored (tool configured to be used with a film placed as such if so desired; film not positively recited, see above; per claim 7); wherein the flexible film is configured to be positioned in the interproximal portion of the mold cavity (tool configured to be used with a film paced as such if so desired; film not positively recited, see above; per claim 8); wherein the first facial mold portion, the second facial mold portion, the first lingual mold portion, and the second lingual mold portion together form inner surfaces corresponding to an outer surface of a tooth prior to restoration (see Figs. 2-3; device can be used on a tooth prior to a restoration procedure if so desired; per claim 9); and the tool further comprising a stiffening bar (17) connecting the first facial mold portion to the second facial mold portion (see Figs. 2-3; per claim 11).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Vuillemot (US 7217131 B2) in view of Hansen et al (WO 2016/094272 A1).
Regarding claim 1, Vuillemot discloses a dental restoration custom tool (see Figs. 8-9 and 13-14), comprising: a mold body (24) for a patient-specific, customized fit with a facial side and a lingual side of at least two adjacent teeth of a patient (see Fig. 8 showing mold extending on facial and lingual sides of teeth and Fig. 9 showing at least two adjacent teeth; Figs. 1-7 showing the process of customizing the mold based on an impression, model, and wax up), wherein the mold body comprises: a first facial mold portion (facial surface of mold 24 corresponding to a first tooth) for the patient-specific, customized fit with the facial side of a first tooth of the patient (see above); a second facial mold portion (e.g. facial surface of mold 24 corresponding to a second tooth, adjacent the first tooth) for the patient-specific, customized fit with the facial side of a second tooth of the patient adjacent the first tooth (see above); a first lingual mold portion (lingual surface of mold 24 corresponding to the first tooth) for the patient-specific, customized fit with the lingual side of the first tooth of the patient; a second lingual mold portion (lingual surface of mold 24 corresponding to the second tooth) for the patient-specific, customized fit with the lingual side of the second tooth of the patient; and a first incisal flexure including a first curved body connecting and integrally joining the first facial mold portion to the first lingual mold portion (incisal surface of mold 24 corresponding to the first tooth, which joins the facial and lingual sides of the mold corresponding to the first tooth; see Fig. 8 showing exemplary curvature of the mold covering the incisal end), and a second incisal flexure including second curved body connecting and integrally joining the second facial mold portion to the second lingual mold portion (incisal surface of mold 24 corresponding to the second tooth, which joins the facial and lingual sides of the mold corresponding to the second tooth; see Fig. 8 showing exemplarily curvature of the mold covering the incisal end), the flexures configured to allow the facial mold portions and the lingual mold portions to articulate relative to one another (configured to articulate (e.g. flex apart) at the curved body at least in part, with sufficient force, due to the flexibility silicone material of the mold (see col 6, lines 47-53) and additionally at col 7, line 26; col 8, lines 3-20 and 58, noting that the mold is snapped off and over the teeth, implicitly involving some articulation to snap on and off). Regarding claim 12, Vuillemot discloses a kit for forming a dental restoration within a mouth of a patient comprising, the tool as described above and a dental restorative material (54; see claim 14). Vuillemot, however, does not teach wherein the mold body of the tool includes a first space between the first facial mold portion and the second facial mold portion, and a second space between the first lingual mold portion and the second lingual mold portion, wherein at least a portion of a flexible film is interposed between the first and second space to form an interproximal portion of a mold cavity between the first and second teeth, wherein the first space and the second space each extend from an occlusal side of the mold body to a gingival side of the mold body, and wherein the mold body is configured to combine with the flexible film to form the mold cavity encompassing missing tooth structure of at least one tooth of the first tooth and the second tooth, the kit further including the flexible film as required.
Hansen et al, however, teaches a similar restoration molding tool with custom lingual and occlusal portions (see abstract and Figs. 19-25), wherein the tool body comprises a first space between the first and second facial mold portions (e.g. slot to receive foil or plastic matrix on labial portion of tool between a first portion corresponding to a labial portion of a first tooth and second portion corresponding to a labial portion of a second tooth, see [0085] and also shown in Figs. 19-21, next to portion 580b; no reference number for space; see labial side of A below) and a second space between the first and second lingual mold portions (e.g. slot to receive foil or plastic matrix on lingual portion of tool between a first lingual portion corresponding to the lingual surface of the first tooth and second lingual portion corresponding to the lingual surface of the second tooth, see [0085] and also shown in Figs. 19-21, next to portion 580b; no reference number for space; lingual side of A), wherein at least a portion of a flexible film (e.g. foil or plastic matrix [0085]) is interposed between the first space and second space to form an interproximal portion of a mold cavity between the first and second teeth (configured to be used as such, see [0085]), wherein the first space and the second space each extend from an occlusal side of the mold body (B, below) to a gingival side of the mold body (C), and wherein the mold body is configured to combine with the flexible film to form a mold cavity encompassing missing tooth structure of at least one tooth of the first and the second tooth (configured to be used as such; see [0085] and cited Figs. above). Hansen et al further discloses a kit comprising the tool, the flexible film and a restorative material (see [0085] and Fig. 23). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Vuillemot to include the first and second spaces between labial and lingual mold portions, as taught by Hansen, and to modify the kit of Vuillemot to include the flexible film, as such modification would help in assuring a custom shape and flash free contact point between the restored teeth and would allow ease of placement and removal of the film therein (see Hansen, [0085]).
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Vuillemot/Hansen, as combined above, additionally discloses wherein the first and second facial portions of the mold body and the first and second lingual portions of the mold body correspond with portions of an existing tooth structure of the patient prior to restoration (e.g. customized fit), the mold body having a geometry selected to provide the patient-specific, customized fit (e.g. correspond at least in part either a) at unrestored surfaces (such as at the gum line and/or lingual surface, see Fig. 7 Vuillemot), b) since the restored surface is based on the unrestored tooth, it has a close similarity thereto (meeting the broadest reasonable interpretation of the term, see Google Dictionary), or c) correspond to post restored shape of tooth, prior to the restoration process). The term “based on three-dimensional scan data from a digital 3D representation or model of an intraoral structure of the patient, the geometry being defined to accommodate an average thickness of the flexible film” is a product by process limitation, that is the mold body is made by 3D scanning. However, as noted in MPEP 2113 product by process limitations are not limited by the particular method of making the product but only the structure imparted thereby. In the instant case the structure imparted by the specific process is the customized fit and space to accommodate an average thickness of the flexible film, which as explained above, Vuillemot/Hansen discloses, meeting the limitations of the claims (per claim 2, see MPEP 2113).
Vuillemot/Hansen, as combined above, further discloses wherein the first incisal flexure includes a first flexure surface that aligns with an incisal surface of the first tooth (e.g. internal surface of first flexure aligns with incisal surface of first tooth, see Vuillemot; per claim 3); wherein the second incisal flexure includes a second flexure surface that aligns with an incisal surface of the second tooth (e.g. internal surface of second flexure aligns with incisal surface of second tooth, see Vuillemot; per claim 4); wherein one or more of the flexure surfaces provides a positional reference surface of the incisal surface of either the first or second tooth (e.g. incisal surfaces contact and abut flexure surfaces, positioning tooth, see Vuillemot; per claim 5); wherein the flexible film is configured to extend from a supragingival surface to a subgingival surface of a tooth to be restored (e.g. plastic or foil matrix is configured to be placed supra and sub gingivally if so desired, see Hansen; per claim 6); wherein the flexible film is configured to extend between a portion of a gingiva of the patient and a subgingival surface of the tooth to be restored (e.g. plastic or foil matrix is configured to extend between a portion of the gingiva and subgingival surface of tooth if so desired; configured to be used as such, see Hansen; per claim 7); wherein the flexible film is configured to be positioned in the interproximal portion of the mold cavity (e.g. plastic or foil matrix is configured to be placed around teeth, including interproximal portions thereof, corresponding to interproximal portion of mold cavity; configured to be used as such if so desired, see Hansen; per claim 8); and wherein the facial mold portions and the lingual mold portions together form inner surfaces corresponding to an outer surface of a tooth prior to restoration (correspond either to pre restored shape (as explained above), and/or correspond to post restored shape of tooth, prior to the restoration process; see citations above Vuillemot; per claim 9).
Claim(s) 11 is rejected under 35 U.S.C. 103 as being unpatentable over Vuillemot in view of Hansen et al, as combined above, further in view of Hansen et al (WO 2017/106431 A1, cited by Applicant; Hereafter Hansen 2).
Regarding claim 11, Vuillemot/Hansen, as combined above, does not teach wherein the device comprises a stiffening bar connecting the first and second facial mold portions as required.
Hansen 2, however, teaches a similar dental mold device (see Figs. 1-2) with a plurality of facial mold portions (15a/14a/14b) with a stiffening bar (29) connecting them together (handle 29 provides increased stiffness compared to a device without handle, at least due to increased thickness/material of the device). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Vuillemot/Hansen, as combined above to include the stiffening bar of Hansen 2, as such modification would allow for easier manipulation, placement and removal of the device, as well as providing increased rigidity (due to increased material thickness).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Please see attached PTO892 form.
THIS ACTION IS MADE FINAL. 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 EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST.
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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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/EDWARD MORAN/Primary Examiner, Art Unit 3772
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