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 .
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: the “oval cylindrical shell” recited in amended claims 1, 3, 9, and 13 is not found in the specification. Additionally, the “dimples” of claim 12 are not found in the specification. The examiner suggests that the applicant amend the specification to “recesses or dimples” if that is the intended meaning of the dimples.
Please note: the amendments to the specification submitted on September 2, 2025 are not entered – see 112(b) rejection below.
The amendment filed September 2, 2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: Claim 9 recites the limitation of a “solid” bottom to preparation cuff. This limitation is not supported by the specification. [0009] of the specification discloses that the preparation cuff can be designed with or without a bottom, but does not disclose that the bottom is “solid”. Figure 3 shows a bottom to the cuff (at 15) but does not disclose that this is solid. For example, were element 15 constructed of a material that is pliable, it would not be solid.
Applicant is required to cancel the new matter in the reply to this Office Action.
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 “the peripheral wall is cross-sectionally wedge-shaped, radially outwardly tapered at the open end” must be shown or the feature(s) canceled from the claim(s). The cross section of the peripheral wall as seen in Figure 2 does not show this limitation, and additional cross sections of the peripheral wall are not shown. No new matter should be entered.
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.
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, 6-10, and 12-13 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 Claims 1-13, the limitation “wherein the peripheral wall is cross-sectionally wedge shaped, radially outwardly tapered and the open end of the oval cylindrical shell” is unclear. As by definition tapering is a reduction or diminishing of a thickness or a narrowing of some kind, it is unclear how the wall can be outwardly tapered. The amendment to the specification and figures do not add clarity to the parameters of this limitation. For the purpose of examination, a peripheral wall that is cross-sectional as seen in the present invention Figure 2 will be considered to meet this limitation.
All other claims not specifically addressed above are rejected based on their dependency on Claim 1.
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.
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.
Claims 1-4, 6-10, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Heasley (US 2004/0265777) in view of Hansen et al. (US 2019/0083208, hereinafter “Hansen”).
Regarding Claim 1, Heasley discloses a dental preparation cuff for exposing a transition region between a tooth neck of a prepared tooth and surrounding gums (abstract), the dental preparation cuff comprising a cylindrical shell (Figure 6) having a circumferentially closed peripheral wall (peripheral wall in Figure 6 is circumferentially closed at the bottom of the figure); and a tooth opening (see Figure 6) an open end of the cylindrical shell for placing the dental preparation cuff on the tooth (as described in [0059]), where the peripheral wall is a-cross-sectionally wedge-shaped, radially outwardly tapered at the open end of the cylindrical shell (as described in [0016], the invention can take a conical form which would be tapered).
Heasley discloses the invention substantially as claimed, and discloses that the ring would form to the shape of the tooth ([0016]), but does not specifically disclose an oval cylindrical shell. In the same art of dental preparation cuffs, Hansen discloses an oval shell (Figure 2C 32b). It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the device of Heasley in an oval shape as taught by Hansen, as during use the Heasley device encircles the tooth which can be an oval shape.
Heasley discloses the invention substantially as described above, but also does not disclose that the dental preparation cuff consists of a material having a shore hardness in the range between 70A and 95A. Hansen teaches that the dental preparation cuff can be made of materials such as PETG film, polyurethane, silicone, and fluoropolymers ([0062]) which can have inherent shore hardnesses in the range between 70A and 95A. It would have been obvious to one having ordinary skill in the art at the time the application was filed to select a material such as PETG film, polyurethane, silicone, or fluoropolymer as taught by Hansen with a known shore hardness between 70A and 95A, to construct the device of Heasley in order to provide a device with adequate structure to securely surround the target dental area.
Furthermore, it is noted that this would have been an obvious matter of design choice, since applicant has not disclosed that having the claimed hardness provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either design.
Furthermore, absent a teaching as to criticality, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding Claim 2, Heasley in view of Hansen discloses the invention of Claim 1 as described above, and Heasley further teaches at least one recess formed in a face of the circumferentially closed peripheral wall at the tooth opening (as seen in Figure 6, there are multiple recesses formed in the outer face of the peripheral wall at the tooth opening).
Regarding Claim 3, Heasley in view of Hansen discloses the invention of Claim 2 as described above, and Heasley further teaches circumferential inner web that extends radially inward of the at least one recess around the opening (Figure 33d, 3a).
Regarding Claim 4, Heasley in view of Hansen discloses the invention of Claim 2 as described above, and Heasley further teaches circumferential outer web that extends radially outward of the at least one recess around the opening (Figure 33d, 3a on the other side of cuff 5a).
Regarding Claim 6, Heasley in view of Hansen discloses the invention of Claim 1 as described above but does not specifically disclose that the cross section of the circumferentially closed peripheral wall is configured to be elliptical with a main axis ratio in the range between 1.1 and 1.5. However, in Figure 2C of Hansen, the drawings appear to show that the main axis ratio is not equal, with one axis greater than the other, which would equate to a ratio with a range between 1.1 and 1.5. As disclosed in the present specification, this limitation is not critical ([0014]) and is “adapted to a tooth anatomy”. Therefore, it would have been obvious to one having ordinary skill in the art at the time the application was filed to configure the peripheral wall in an elliptical shape as taught by Hansen in the device of Heasley in view of Hansen in order to approximate the anatomy of a tooth ([Hansen 0031 and 0042]) which would render the main axis ratio in the same range as claimed.
Regarding Claim 7, Heasley in view of Hansen discloses the invention of Claim 1 as described above, and Hansen further teaches that the peripheral wall has a wave-shaped axial contour with two axial maximum extension regions (Figure 3, not labeled but the tip where perimeter 38 is indicating would be the maximum extension regions) and two axial minimum extension regions (Figure 3, 32a and 32b). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to utilize the shaping of the perimeter of Hansen with the circumferentially closed peripheral wall of Heasley in view of Hansen in order to more closely approximate the tooth/gum interface shape.
Regarding Claim 8, Heasley in view of Hansen discloses the invention of Claim 6 as described above but does not specifically disclose that the axial spacing between the maximum extension regions and the minimum extension regions is implemented in the range between 0.8 times and 1.2 times a smaller main axis extension of the elliptical cross-section of the peripheral wall. However, in Figure 2B of Hansen, the drawings appear to show that a measurement of the axial spacing between the maximum extension regions and the minimum extension regions would be in a range between .8 and 1.2 times a smaller main axis extension of the elliptical cross-section of the peripheral wall. It would have been obvious to one having ordinary skill in the art at the time the application was filed to construct the spacing between the maximum extension regions and the minimum extension regions implemented in the range between 0.8 times and 1.2 times a smaller main axis extension of the elliptical cross-section of the circumferentially closed peripheral wall of Heasley in view of Hansen in order to accommodate the anatomy of the tooth.
Regarding Claim 9, Heasley in view of Hansen discloses the invention of Claim 1 as described above, and Hansen further teaches a solid bottom (Figure 2C, and as seen in Figure 2B annotated below) of the preparation cuff with a the tooth opening is configured as a blind hole (Figure 2C shows the opening for the tooth), where the solid bottom of the tooth opening has a thickness which is greater than a quarter of a total axial extension of the preparation cuff perpendicular to a bottom surface of the bottom (see Figure 2B as annotated below where this ratio would apply as any section of the body (12) could be construed as the “bottom” and therefore could meet this parameter). It would have been obvious to one having ordinary skill in the art to modify the device of Heasley in view of Hansen with the bottom structure of Hansen in order to provide additional support for the preparation cuff.
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Regarding Claim 10, Heasley in view of Hansen discloses the invention of Claim 1, and Hansen further teaches that the cuff can be manufactured by a 3D printing method ([003]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to construct the device of , Heasley in view of Hansen by 3D printing as taught by Hansen, as this is a well-known method for constructing dental materials. Please note as this is a product-by-process claim, the claim is not limited to the manipulations of the recited steps, only the structure implied by the steps (see MPEP 2113).
Regarding Claim 12, Heasley in view of Hansen discloses the invention of Claim 1, and Heasley further discloses a plurality of radially elongated dimples (see Figure 6) that are circumferentially spaced in a face of the circumferentially closed peripheral wall around the tooth opening.
Regarding Claim 13, Heasley in view of Hansen discloses the invention of Claim 1, and Heasley further discloses the wedge-shaped, radially outwardly tapered open end of the oval cylindrical shell (as disclosed in [0016] of Heasley, the shell can be a conical or a cylindrical dome which would meet this limitation) which would be capable of lifting off or moving the surrounding gums.
Response to Arguments
Applicant’s arguments with respect to claims 1-4, and 6-10 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claims as described above are rejected over Heasley in view of Hansen.
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 CHRISTINE L NELSON whose telephone number is (571)270-5368. The examiner can normally be reached M - F 7:30-4:30 ET.
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, 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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/CHRISTINE L NELSON/Examiner, Art Unit 3772 /EDWARD MORAN/Primary Examiner, Art Unit 3772