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 with respect to amended claim 1 have been considered but are moot in view of the new ground of rejection necessitated by amendment. In particular, the rejections below rely on Kumar (US 2007/0019816) to teach a tissue former where the shoulder region is at the interface between the cap portion and the conical portion and that shoulder is also the apex or widest portion of the tissue former. 3
Claim Interpretation
“About” is defined in the specification as being “within plus or minus 10 percentage of the referenced linear dimension or angle” in paragraph [0027].
In Claim 1, “encompasses the tissue former” is being interpreted as extending around the entire circumference of the tissue reformer.
Claim Objections
Claim 16 objected to because of the following informalities: “wherein the tissue former is coupled to the dental implant with a fastener” should be “wherein the tissue former is configured to couple to the dental implant with a fastener.” Appropriate correction is required.
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 1-2, 5-13, 16-18, and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar (US 2001/0019816) in view of Szakacs et al. (EP 2526892).
Regarding Claim 1, Kumar teaches a tissue former (healing cap 22) configured to couple to a dental implant (Figure 2; ¶ 0055)), comprising:
a base portion arranged at a first end of the tissue former (bottom of healing cap 22, as shown in annotated Figure 4A below);
a cap portion arranged at a second end of the tissue former (portion of healing cap above widest portion of healing cap 22), the first and second ends being opposite from each other along a central longitudinal axis of the tissue former (cap portion is top of healing cap and base is bottom of healing cap as shown in Figure 4C), wherein the cap portion comprises a flat surface extending perpendicular to the central longitudinal axis and a rounded surface disposed radially outward from the flat surface (see annotated Figure 4A below);
a conical portion (extends from base to widest portion of healing cap 22, see annotated Figure 4A below) defining a surface that extends from the base portion towards the cap portion and encompasses the tissue former, wherein the tissue former has radial symmetry about the central longitudinal axis (Figures 4B and 4C show the healing cap in views along the longitudinal axis which show radial symmetry) ; and
a shoulder portion (widest portion of the healing cap, see annotated Figure 4A below) arranged at an interface between the rounded surface of the cap portion and the conical portion (see Figure 4A below), the shoulder portion comprising an apex having a diameter greater than (i) a diameter of the base portion and (ii) a diameter of the cap portion (shoulder is defined as the widest portion of the healing cap and therefor the diameter is greater than any diameter of the base or cap portion).
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Kumar does not explicitly teach the conical portion being curved and concave.
However, Szakacs, in the same field of endeavor of tissue shaping devices for use with dental implants (abstract), teaches a tissue former (gum-shaping screw 110) comprising a base portion (distal portion 114 and distal neck portion 116b); a cap portion (see annotated Figure 1b below) at the opposite end along a central longitudinal axis see annotated Figure 1b), wherein the cap portion comprises a flat surface extending perpendicular to the central longitudinal axis and a rounded surface disposed radially outward from the flat surface (Figures 1b and 1c); a concave conical portion (proximal neck portion 16a) defining a curved surface (concave curvature 22) that extends from the base portion towards the cap portion and encompasses the tissue former (Figure 1b), wherein the tissue former has radial symmetry about the central longitudinal axis (Figure 1C); and a shoulder portion (see annotated Figure 1b) between the cap portion and the curved surface of the concave conical portion (shoulder is between these portions, as seen in Figure 1b; given the shoulder has significant height, it spans the distance between these portions, but at a consistent diameter) with a diameter greater than a diameter of the base portion and a diameter of the cap portion (seen in Figure 1b that the shoulder is the widest portion). Szakacs teaches that the curved concave surface helps integration with the gum tissue (¶ 0020).
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Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue former as taught by Kumar to include the conical portion being curved as taught by Szakacs in order to help the surface integrate with the gum tissue (Szakacs ¶ 0020).
Regarding Claim 2, Kumar teaches wherein the base portion (bottom of healing cap 22 as shown in annotated Figure 4A above) is configured to abut with a dental implant (Figure 6). It is well known that dental implants and abutments can be separate or integral pieces, therefore it would be obvious to make the base of the tissue former configured to abut an abutment associated with the dental implant if the dental implant and abutment were integral so the tissue former could still be used with the single piece implant.
Additionally, this limitation is functional, and the tissue former as taught by Kumar and Szakacs in Claim 1 is fully capable of abutting with an abutment associated with a dental implant.
Regarding Claim 5, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Szakacs further teaches wherein a curvature of the curved surface varies continuously between the base portion and the shoulder portion (curvature 122 appears to vary along proximal neck portion 116a).
Regarding Claims 6-8, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar does not teach a specific diameter for the tissue former. Szakacs teaches the diameter of the widest portion of the tissue former (proximal gum shaping portion 12) being about 3-7 mm (Fig. 2a description between ¶ 0013 and ¶ 0014).
Therefore, while Kumar and Szakacs do explicitly teach the claimed diameters of about 6.8 mm (6.12-7.48 mm; Claim 6), about 7.6 mm (6.84-8.36 mm; Claim 7), or about 8.2 mm (7.38-9.62 mm Claim 8), the diameter range taught by Szakacs does overlap that of claims 6 and 7. Furthermore it would have been obvious to one of ordinary skill in the art to make the diameters of the shoulder portion that size if necessitated by the dental implant diameter or the size of the area of the gingival tissue that needed to be shaped. The diameters taught by Szakacs are close and Kumar shows that the diameter of the tissue former should be larger than the dental implant diameter (see Figure 6). Furthermore, the applicant appears to place no criticality on the claimed diameter, indicating in the instant application that these diameters are optional (¶ 7).
Regarding Claim 9, Kumar and Szakacs teach the tissue former of claim 6, as presented above. Szakacs further teaches wherein a curvature of a surface of the concave conical portion is dependent on the diameter of the shoulder portion (the diameter of the cylindrical face can vary as it is taught as being in a range (Fig. 2a description between ¶ 0013 and ¶ 0014) and the base is taught as being dependent on the type of implant the gum-shaping screw is compatible with (¶ 0020) therefore the curve of the surface will depend on those parameters).
Szakacs teaches that the concave conical portion is curved in order to improve integration with the gum tissue (¶ 0020). Szakacs further teaches that the base diameter will be dependent on the type of implant with which the tissue former is compatible (¶ 0020).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue former taught by Kumar with the curved conical portion taught by Szakacs to also include the curvature of a surface of the concave conical portion being dependent on the diameter of the shoulder portion as also taught by Szakacs. The shoulder portion diameter would be determined by the necessary hole size in the gums, and Szakacs teaches the base size is dependent on the implant (¶ 0020). Therefore if the base is for a certain implant that is constant, the curvature would depend on the diameter of the shoulder portion selected for the necessary hole size in the gums, assuming the height remained constant.
Regarding Claim 10, Kumar and Szakacs teach the tissue former of claim 9, as presented above. Szakacs further teaches wherein a slope of the curvature of the surface of the concave conical portion is variable between the base portion and the shoulder portion (Figure 2b). When the slope is relative to the vertical midline of the tissue former and the concave conical portion is curved rather than linear, as taught by Szakacs in order to better integrate with the gums (¶ 0020), the slope varies along the length of the curve relative to the vertical midline. In contrast, a linear conical portion would have a constant slope.
Regarding Claim 11, Kumar and Szakacs teach the tissue former of claim 10, as presented above. Szakacs further teaches wherein the slope of the curvature of the surface of the concave conical portion is steepest in proximity to the base portion (Figure 2b shows the slope of the curve near the base is almost vertical relative to the vertical midline of the tissue former therefore is steepest there).
Regarding Claim 12, Kumar and Szakacs teach the tissue former of claim 10, as presented above. Szakacs further teaches wherein the slope of the curvature of the concave conical portion is gentlest in proximity to the shoulder portion (Figure 2b, the slope of the curve near the near the shoulder is gentlest relative to the vertical midline of the tissue former).
Regarding claims 11 and 12, the slope of curvature is gentlest in proximity of the shoulder portion and steepest in proximity of the base portion as a result of the concave curved shape of the conical portion taught by Szakacs. If the conical portion was linear the slope would be constant and if the conical portion was convex the slope would be steepest near the shoulder portion and gentlest near the base. All such sloped determined relative to the vertical midline. See example figure below.
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Regarding Claim 13, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar teaches the device further comprising a cavity (central bore 24) extending internally between the base and cap portions along the central longitudinal axis (Figure 4D shows cross section of healing cap 22), wherein the cavity includes a cylindrical portion (middle portion of central bore 24 as shown in Figure 4D) and a conical portion (top portion of central bore 24 as shown in Figure 4D).
Regarding Claim 16, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar further teaches wherein the tissue former is coupled to the dental implant with a fastener (Figure 6 shows coupling screw 28 attaching healing cap 22 to implant body 12) .
Regarding Claim 17, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar further teaches wherein the dental implant is part of a multi-unit dental system (Figure 2).
Regarding Claim 18, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar teaches wherein the tissue former is made from a biocompatible material (¶ 0058).
Regarding Claim 20, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar further teaches wherein the shoulder portion is shaped to provide a smooth transition between the cap portion and the conical portion (see annotated Figure 4C where the shoulder is only the widest portion where the transition between the conical portion and the curved part of the cap portion occurs, and given the cap is for use when healing the gums, it is obvious the cap should have smooth edges so as to not continually damage the tissue).
Regarding Claim 21, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar further teaches wherein an outer circumferential surface of the tissue former lacks a linear surface extending parallel to the central longitudinal axis such that the apex of the shoulder portion is a point of maximum diameter of the tissue former (see annotated Figure 4A above, where the shoulder is defined as being the widest part of the healing cap and therefore the apex and maximum diameter, and no linear surface parallel to the longitudinal axis is present on the exterior surface of the healing cap.).
Claims 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar (US 2001/0019816) and Szakacs et al. (EP 2526892) as applied to claim 13 above, and further in view of Buser (WO 97/20518; translation provided with previous office action).
Regarding Claim 13, Kumar and Szakacs teach the tissue former of claim 1, as presented above. Kumar teaches the device further comprising a cavity (central bore 24) extending internally between the base and cap portions along the central longitudinal axis (Figure 4D shows cross section of healing cap 22). While Kumar does also teach wherein the cavity includes a cylindrical portion (middle portion of central bore 24 as shown in Figure 4D) and a conical portion (top portion of central bore 24 as shown in Figure 4D), the conical portion as taught by Kumar is intended for the fastener.
However, Buser, in the same field of healing caps for dental implants (abstract), teaches wherein the cavity along the central longitudinal axis (axial through-bore 320) includes a cylindrical portion (screw head receptable 323) and a conical portion (counter shoulder 321), where the cavity’s conical portion is designed to accommodate the dental implant (implant 1) on which the tissue former (protective cap 300) is configured to be coupled (see Figure 5A). Buser teaches the through cavity including a conical portion such that it is complementary to the implant (translation page 5 in description of Figures 4A and 4B).
Kumar also teaches that the cavity shape is dependent on the shape of the implant with which it is to be used (¶ 0021, 0059).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the tissue former as taught by Kumar and Szakacs to have a conical region in the internal cavity at the base end of the tissue former as taught by Buser in order to be complementary to an implant with a such a conical abutment area (Buser translation page 5 in description of Figures 4A and 4B). In additional to Kumar stating the tissue former is shaped to compliment the implant, Szakacs also supports a modification to make the base of the tissue fit the dental implant to be used, indicating the shape and dimensions of the part of the former that abuts the implant is determined by the type of implant it needs to be compatible with (Szakacs ¶ 0020).
Regarding Claim 14, Kumar, Szakacs, and Buser teach the tissue former of claim 13, as presented above.
Buser further teaches wherein the conical portion of the cavity comprises a step portion (short cylindrical section 325 in combination with short conical section above), wherein the step portion is tapered at an angle of about 120 degrees (see annotated Figure 4A below; the protective cap or healing abutment includes counter shoulder 321 that is conical and then steps down to the cylindrical portion in multiple steps, at least one of which is tapered at an angle of about 120 degrees). Buser teaches the through cavity including a conical portion such that it is complementary to the implant (translation page 5 in description of Figures 4A and 4B).
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Regarding Claim 15, Kumar, Szakacs, and Buser teach the tissue former of claim 13, as presented above.
Buser teaches therein the cavity along the central longitudinal axis (axial through-bore 320) has a conical portion (counter shoulder 321) to accommodate and complement the implant (translation page 5 in description of Figures 4A and 4B).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cavity of the tissue former as taught by Kumar and Szakacs to include the recess for the implant being conical shaped as taught by Buser in order to accommodate an implant which such a shape. Furthermore, Buser, Kumar, and Szakacs all teach the tissue former must be complementary to the implant on which it is installed (Buser translation page 5 in description of Figures 4A and 4B; Kumar (¶ 0021, 0059; Szakacs ¶ 0020). Therefore if the implant on which it will be installed has a concave top, it would be obvious to one of ordinary skill in the art that the base portion on the first end of the tissue former should further comprise a convex base surface at least partially defining the conical portion of the cavity.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar (US 2001/0019816) and Szakacs et al. (EP 2526892) as applied to claims 18 above, and further in view of DE 102014105884 A1.
Regarding Claim 19, Kumar and Szakacs teach the tissue former of claim 18, but do not explicitly teach the biocompatible material being printed with a 3D printer. Such a limitation is a product by process limitation, and thus requires that that tissue former be fabricated from a material that can be 3D printed, but the tissue former does not need to be 3D printed if it is such that it could be 3D printed.
Kumar teaches the tissue former being fabricated out of metal or metal and Teflon (¶ 0058). But other materials are known to be appropriate for tissue formers or healing caps, and such other materials can be 3D printed.
DE 102014105884 A1, in the same field of endeavor of healing abutments or tissue formers (abstract), teaches wherein the biocompatible material forming the tissue former (translation page 2 third paragraph; translation bottom of page 3 into page 4 provides plastic biocompatible materials out of which the healing cap can be made) is printed using a three-dimensional (3D) printer (translation page 3 third paragraph from bottom of page). Three-dimensional printing is taught as a preferred fabrication method for the tissue formers because it is easy and quick (translation page 3 third paragraph from bottom of page).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the tissue formers as taught by Kumar and Szakacs to be fabricated from a material that can be manufactured by 3D printing as taught by DE 102014105884 A1 because such a manufacturing method is easy and quick (translation page 3 third paragraph from bottom of page).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sutter (WO 9852487) teaches a healing cap (85) that appear to have concave sides connecting the base to the shoulder, which is then connected to the rounded surface of the cap portion, and the shoulder is an apex of the device. The healing cap also has a central bore. However, it is unclear if the cap is circular such that the curved portion of the cap extends outward radially.
Robb et al. (US 2012/0295226) teaches a temporary healing abutment where the conical portion has either a linear or curved concave outer surface.
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.
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/JENNIFER P CONNELL/ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
3/13/2026