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 .
Claim Rejections - 35 USC § 112(b)
2. 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.
Claim 1-3 and 5-22 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.
As amended, claim 1 (lines 5-8) and claim 5 (lines 7-10) each recites:
“the inner part comprises an outer radius having an outer radius minimum value”, and
“the cavity comprises an inner radius having an inner radius minimum value”.
It is unclear whether the term “radius” refers to (i) a radius of curvature of a surface contour, or (ii) a radial dimension measured from the element’s center or axis to the element’s surface.
A radius itself is a single value; it is unclear how a single radius “having” a radius minimum. It is also unclear whether “radius minimum value” refers to (i) the minimum of a single varying radius, or (ii) the minimum of a plurality of radii present on the substrate element.
Note that the specification does not define the term “radius” or a method of measuring such radius. The specification indicates the inner part has an asymmetric shape and/or formed to be non-rotationally symmetrical (Specification page 4 lines 25-30), but does not specify what would be the reference center/axis to measure the radius of such asymmetrical or non-rotationally symmetrical structure.
For examination under the prior arts, the limitation “radius” is interpreted as encompassing either a radius of curvature of a surface contour or a radial dimension measured from the element’s center or axis
As amended, claim 1 (lines 16-17) and claim 5 (lines 19-20) each recites: “a roughness depth value Rc …” , which is indefinite because it appears to be claiming two different distinct parameters “roughness depth” and “Rc” as one parameter.
Conventionally, “roughness depth” denotes Rz, whereas “Rc” denotes the mean height of profile elements (ISO 4287 International Standard on Surface Texture). It is unclear which surface roughness parameter is being claimed - roughness depth (Rz) or mean height of profile elements (Rc)?
Note that the specification also merely states “The roughness depth value Rc…” (page 4 lines 1-2), without any further definition or elaboration of the term. While the specification provides measurement method for “average roughness value Ra” (page 3 lines 12-29), it does not provide any measurement method for either “roughness depth” or “Rc”. Therefore, one of ordinary skill in the art cannot ascertain the metes and bounds of “a roughness depth value Rc”.
For examination under the prior arts, the limitation is interpreted as encompassing either one of the parameters Rc or Rz.
As amended, claim 1 (lines 16-17) and claim 5 (lines 19-20) each recites “the defined surface roughness of the inner surface…”, which is indefinite as lacking sufficient antecedent bases in the claims. Note that claims 1 and 5 each previously defines “at least part of the inner surface has an arithmetic average roughness (claim 1 lines 10-11, claim 5 lines 13-14). It is unclear whether “the defined surface roughness” is the same as or different from the previously recited “an arithmetic average roughness”. It is also unclear whether “the define surface roughness of the inner surface” refers to a roughness parameter of at least part inner surface or of the entire inner surface.
Claim 1 preamble recites “An artificial tooth element for direction insertion into a cavity of a prosthesis base”. As such, per the preamble, the claim is directed to an artificial tooth element only, whereas “a cavity of a prosthesis base” is an element within an intended use clause, and is not positively claimed.
Claim 1, as amended, further limits the cavity of the prosthesis base in the claim body: “the cavity comprises an inner radius having an inner radius minimum value…equal to or greater than the outer radius minimum value” (lines 7-9), thereby essentially connects the cavity to the artificial tooth element. It is unclear whether the prosthesis base and its cavity are positively claimed elements of the invention. It is unclear whether the claim is directed (i) to the artificial tooth element alone (per the claim preamble), or (ii) to the artificial tooth element in combination with the cavity of the prosthesis base (per the claim body).
For examination under the prior arts, the claim is interpreted as directed to the artificial tooth element alone (per the claim preamble), and that said artificial tooth element is capable of being inserted into a prosthesis base’ cavity having the recited radius relationship.
The dependent claims are rejected herein based on dependency.
Claim Rejections - 35 USC § 103
4. 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 1-3 and 5-20 are rejected under 35 U.S.C.103 as being unpatentable over Sagolla et al. (US 2017/0367798) in view of Yeh et al. (US 2013/0216787) and Menke (US 2008/0113316).
Claims 1-3 and 15-19:
Regarding claims 1 and 15-19, Sagolla et al. discloses an artificial tooth element 4 for direct insertion into a cavity 2 of a prosthesis base 1 (Figs. 1-2). The artificial tooth element 4 (Fig. 2) comprises: an outer part 10 visible in the inserted state and an inner part (basal side 12) not visible in the inserted state (Figs. 1-2). The inner part 12 comprises a defined surface roughness at least in part. See paragraphs [0047]-[0050] emphasis added: “the basal surfaces of the prosthesis teeth are swelled… with a solvent… The abrading or roughing of the surface can be incurred by the solvent”. Also see paragraph [0084]: “at least the basal sides 12 of the prosthesis teeth 4 are cleaned and, to improve the connection with the connecting means 8, are abraded and swelled with a solvent”.
Regarding the newly recited limitations, note Sagolla et al. discloses cavities/sockets with vertical side walls that cover and surround the neck portion 12 of an artificial tooth 4; Consequently, the minimum inner radius of the cavity socket is equal to or greater than the minimum outer radius of the inserted tooth's basal side 12 (see Sagolla et al. Figs. 1-2 ;[0052] “the tooth sockets of the… base are larger than the corresponding basal surfaces of the prosthesis teeth”).
As to the specifically claimed ranges of surface roughness in claims 1 and 15-19, Sagolla et al. discloses the inner part 12 comprises a defined surface roughness at least in part (paragraphs [0047]-[0050] “the basal surfaces of the prosthesis teeth are swelled… roughed up…”; paragraph [0084] “at least the basal sides 12 of the prosthesis teeth 4 are cleaned and, to improve the connection with the connecting means 8, are abraded and swelled with a solvent”). Therefore, the inner part/basal sides 12 has a surface roughness greater than that of the outer surface roughness. However, Sagolla et al. fails to disclose the specifically claimed ranges of an arithmetic average roughness value Ra of > 0 to 30 µm, and a roughness depth value Rc between 5 and 25 µm.
Yeh et al. discloses a dental ceramic article 100 comprising a body 110 and a porous layer 120 formed on the surface thereof so as to increase the surface roughness (Fig. 1; [0011] “a ceramic article with an increased surface roughness… allow the penetration of resin adhesive thereby increasing the contact area of the ceramic/adhesive interface… improve the bonding strength between the ceramic article and the resin adhesive”; [0017] “forming a composite porous layer… thereby increasing the surface roughness of the ceramic article”; [0049] “pores (voids) are formed on the surface of the composite porous layer 120… allow the penetration of the resin adhesive that is used to fix the ceramic article 100 to an underlying structure”).
As applicable to Sagolla’s and the claimed invention, Yeh Fig. 3 shows a prosthesis 300 including an artificial tooth 304 having inner part 330 for adhesive retention to an underlying structure 306, wherein the inner part 330 has an inner surface 312 which is treated to form composite porous layer 320 with an increased average surface roughness Ra of at least about 0.5 µm, or preferably about 0.85-1.7 µm (Fig. 3; [0050]-[0054] “insertion recess 330 is treated in accordance with the method described herein to form a composite, porous layer 320 thereon”).
Per claim 1, Yeh’s treated inner surface has an increased average surface roughness Ra of 0.85 - 1.7 µm is within the recited ranges Ra of > 0 to 30 µm (as recited in claim 1). Per claims 15-18, Yeh’s inner surface roughness Ra of 0.85-1.7 µm wis within the claimed range of Ra of >0 to 10 µm, about 0.5 to about 5 µm, about 1 to about 4 µm, and about 2 to 3 µm (as recited in claims 15-18).
Yeh treats only the inner surface (engagement surfaces) to have an increased roughness, while the outer part surface (untreated polished surfaces) has a polished surface with Ra of about 0.02 µm ([0056] “green blank…was sanded and polished… an average surface roughness of about 0.02 µm”). Therefore, Yeh’s treated inner surface with an increased average surface roughness Ra (about 0.85-1.7 µm) is greater than the polished outer surface roughness Ra (about 0.02 µm), as recited in claim 1.
Per claim 9, Yeh discloses it has been known that etching would increase the surface roughness from about 0.02 µm to about 0.03 (see Yeh [0073]), making the treated inner surface roughness Ra (about 0.03 µm) to be 50% greater than the polished outer surface roughness Ra (about 0.2 µm).
Regarding the roughness depth Rc/Rz, note that the roughness of Yeh’s treated surface is formed within the porous layer 120, which has a thickness of about 5 to 20 µm (0050]). The roughness depth of that the layer 120’s is necessarily in the order of or within the layer’s thickness 5 to 20 µm, which is within the claimed range of 5 to 25 µm.
Alternatively, Menke discloses a dental implant 10 having roughened surface (Fig. 1), specifically [0028] “strongest biochemical bond is achieved at a surface roughness of approximately 1.5 µm (mean roughness value Ra);… an optimal surface structure is obtained at a mean roughness value Ra of approximately 1 µm and an average peak-to-valley height Rz of 11 µm”.
Meh’s mean roughness value Ra of approximately 1 µm is within the recited ranges Ra of > 0 to 30 µm (as recited in claim 1), a of >0 to 10 µm, about 0.5 to about 5 µm, about 1 to about 4 µm, and about 2 to 3 µm (as recited in claims 15-18).
Meh’s average peak-to-valley height Rz of 11 µm is considered to be equivalent to and is within the claimed roughness depth value Rc range of between 5 to 25 µm (as recited in claim 1).
Considering Yeh and Menke each effectively indicates that such average roughness Ra and roughness depth Rc/Rz are of result effective variables for improving bonding strength of the inner surface of a tooth/prosthesis as detailed above, and that Yeh’s and Menke’s disclosed ranges also within the claimed ranges, such claimed ranges of average roughness Ra and roughness depth Rc of the inner surface roughness and the comparison(s) between the inner surface roughness and the outer surface roughness would have been obvious to one having ordinary skill in art at the time the invention was made since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
As to claims 2-3, Sagolla et al. discloses the inner part/basal surface 12 having the surface roughness across the entire basal surface 12 to bond to adhesive 8 (Figs. 2-3; paragraph [0050] “The abrading or roughing of the surface… effective surface area for connection to the connection means is enlarged and therefore the retention of the prosthesis teeth in the prosthesis base is improved).
Claims 5-14 and 20:
Regarding claims 5 and 20, Sagolla discloses a prosthesis 1/4 with a prosthesis base 1 having a plurality of cavities 2, wherein in each of which an artificial tooth element 4 is inserted (Figs. 1-2). The artificial tooth element 4 (Fig. 2) comprises: an outer part 10 visible in the inserted state and an inner part (basal side 12) not visible in the inserted state (Figs. 1-2). The artificial tooth element 4 is adhesively bonded (via connection means 8) to the base 1’s socket 2 (Fig. 2; [0085]-[0088] “connecting means 8 of a self-hardening cement”).
Sagolla in view of Yeh and Menke discloses or makes obvious the tooth’s inner part comprising an outer radius, base’s cavity comprising an inner radius, and the claimed ranges of average roughness Ra and roughness depth Rc/Rz as detailed above with respect to claims 1 and 19.
As to claims 6-8, Sagolla et al. discloses that each of the plurality of cavities 2 having an inner surface (best pointed to by reference numeral 2 in Fig. 2). Such inner surface of the cavity/socket 2 as a whole has a defined surface roughness in the region of a bonding surface (paragraph [0049] “the tooth sockets of the prosthesis base are roughed up…”; paragraph [0084] “the tooth sockets 2… are cleaned and, to improve the connection with the connection means 9, are abraded and swelled with a solvent”). As to claim 9, Sagolla et al. fails to disclose an arithmetic average roughness value Ra of > 0 to 30 µm for the inner surface of cavity 2. However, Yeh et al. discloses an engagement surface having an increased “average surface roughness… about 0.85-1.7 µm” (paragraph [0049]) which is within the recited range Ra of > 0 to 30 µm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Sagolla et al. by forming the inner part/basal surface of the artificial tooth prothesis having the disclosed range of roughness Ra as taught by Yeh et al. in order to achieve optimum holding stable adhesive strength to denture base glue. Furthermore, considering Yeh et al. indicating that such range of average roughness is of optimizable variables, such claimed ranges of roughness Ra would have been obvious to one having ordinary skill in art at the time the invention was made since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
As to claims 10-12, Sagolla et al. discloses the cavities 2 being free from undercuts and are formed with different shapes complementary to the inner part/basal surface 12 of the artificial teeth 4 (Figs. 1-3, paragraph 24). Note that there is a gap (intermediate space) between the cavity 2 and the inner part 12 of tooth 4; such gap/intermediate space is filled with connecting means 8 of self-hardening cement (paragraphs [0085]-[0088] “the intermediate spaces between the tooth sockets 2 and the prosthesis teeth 4 are filled with the connecting means 8”). Note that the width of such gap would have been obvious since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
As to claims 13-14, Sagolla et al. discloses the cavities 2 are formed taking into consideration of the artificial tooth 4’s neck area 12 and height; and having a minimum inner radius that is equal to or greater than the minimum outer radius of the inner part 12 of tooth 4 in order to receive the inner/basal part 12 of tooth 4 therein ( Fig. 2; paragraphs [0084] “tooth sockets 2 are somewhat larger than… the basal side 12 of the prosthesis teeth 4”).
Claims 21-22 are rejected under 35 U.S.C.103 as being unpatentable over Sagolla et al. in view of Yeh et al. and Menke, and further in view of Michii et al. (WO 2015/194449). Also refer to the attached herein machine English translation of Michii et al.
Sagolla/Yeh/Menke discloses the invention substantially as claimed as applied to claims 1 and 5 as detailed above. However, per claims 21-22, Sagolla/Yeh/Menke fails to disclose the outer radius minimum value is 0.6 mm or greater.
Michii et al. discloses an artificial tooth 21 inserted into a socket 13 of a denture base 11g, wherein the tooth 21 has outer/convex radius 21a with an outer radius value of 0.3 mm or more and 1.0 mm or less (Figs. 2B and 5B; English translation page 3, first paragraph), which at least overlaps with the claimed range of 0.6 mm or greater. Therefore, such claimed range of outer radium minimum value is 0.6 mm or greater would have been obvious to one having ordinary skill in art at the time the invention was made since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
Response to Arguments
7. Applicant's arguments regarding the amended claims have been fully considered, but are not found persuasive. The claims are rejected under Sagolla in view of Yeh and Menke as detailed above. Regarding the newly recited limitations that the inner part comprises an outer radius and the cavity comprise an inner radius, note Sagolla et al. discloses cavities/sockets 2 with vertical side walls 2 that cover and surround the neck portion 12 of an artificial tooth 4 (see Sagolla et al. Figs. 1-2; [0052] “the tooth sockets of the base are larger than the corresponding basal surfaces of the prosthesis teeth”). Therefore, the minimum inner radius of the cavity socket is equal to or greater than (since it covers and surrounds) the minimum outer radius of the inserted tooth's basal side 12.
Regarding the newly claimed “roughness depth value Rc between 5 and 25 µm”, note the above 112(b) ground of rejection, and that “roughness depth value Rc” is interpreted as best understood - as encompassing either one of the parameters roughness depth Rz or roughness height Rc. Sagolla et al. discloses the inner part/basal surfaces 12 of artificial tooth 4 having a surface roughness, but fails to disclose the specifically claimed ranges of Ra and Rc. Yeh et al. discloses an artificial tooth 304, whose engagement surface 312 for adhesive retention to an underlying structure is treated to form layer 320 having an increased average surface roughness Ra of at least 0.5 µm, preferably 0.85-1.7 µm for the purpose of increasing contact area and bond strength to the resin adhesive (Yeh [0011]-[0013], [0049]-[0054]); the disclosed range is within the claimed range of average surface roughness Ra of >0 to 30 µm. Menke discloses a dental component’s surface roughness value Ra of 1.5-2 µm and an Rz of 5-15 µm as an optimal surface structure for biochemical bond (Menke [0028]); the disclosed ranges of Ra and Rz are within the claimed ranges of Ra and Rc respectively. Considering Yeh and Menke each effectively indicates that such average roughness Ra and roughness depth Rc/Rz are of result effective variables for improving bonding strength of the inner surface of a tooth/prosthesis as detailed above, and that Yeh’s and Menke’s disclosed ranges also within the claimed ranges, such claimed ranges of average roughness Ra and roughness depth Rc of the inner surface roughness and the comparison(s) between the inner surface roughness and the outer surface roughness would have been obvious to one having ordinary skill in art at the time the invention was made since it has been held that discovering an optimum or workable ranges is well within the skill of an artisan via routine experimentation in order to improve upon what is already generally known. See MPEP §§ 2144.05.
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 HAO D MAI whose telephone number is (571)270-3002. The examiner can normally be reached Mon-Fri 8:00-4:30. 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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/Hao D Mai/Examiner, Art Unit 3772
/ERIC J ROSEN/ Supervisory Patent Examiner, Art Unit 3772
