Status under America Invents Act
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Rejections based on 35 U.S.C. 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.
Claim 29 is 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.
In claim 29, it is unclear from what the bacterial colonization and gingival downgrowth is “reduced” in comparison to.
Rejections based on Prior Art
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 1-8, 10-18, 21, 22, and 24-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hansson (US 2011/0306016).
In Figure 1a Hansson discloses a dental implant 2 having an outer surface (i.e. “functionalized surface operable to be integrated with a first type of mammaliam tissue”). The outer surface includes threads 4 (i.e. “first macroscale shape of spatial extension”) with a first machined micro scale surface texture (pits 14, Figure 1b) and a first nanoscale surface topography formed on the first machined microscale surface (nanostructure 22, Figure 1c). It is noted that applicant’s written description defines “microscale” as “surface relief elements or structures [that] are predominately greater than about 2 micrometers and smaller than about 100 micrometers” and “nanoscale” as “surface relief elements or structures [that] are predominately smaller than about 2 micrometers” (paragraph [0048]). Hansson indicates that the threads 4 may be “microthreads” (depth of .02mm - .2mm) or “macrothreads” (depth greater than 0.2mm)(paragraph [0056]); that the pits 14 have a depth of 6µ (micrometers) for example (paragraph [0057]); and that the nanostructure 22 have a size of about .1µ (micrometers)(paragraph [0057]) which meets applicant’s definitions of “microscale” and “nanoscale.”
In regard to claims 2-7, the Hansson dental implant is capable of being implanted such that the textured threaded surface 4 contacts bone tissue, mucosal tissue, cutaneous and/or periodontal tissue of a mammal. The particular type of tissue that applicant intends for the claimed implant to contact fails to impose any objectively ascertainable structural distinctions from the implant disclosed by Hansson. More particularly with respect to claims 6-8, 10 and 11, the Hansson implant 2 is capable of being implanted such that the lower part (“first functionalized surface”) of the implant contacts a patient’s jaw bone and an upper part (“second functionalized surface”) of the implant contacts the patient’s periodontal/gum/ mucosa tissue.
In regard to claims 13 and 14, the “custom-shaped” limitation fails to impose any objectively ascertainable structural distinction from the implant disclosed by Hansson. Whether or not a Hansson implant “custom” fits the socket or gingival margin of a particular patient depends on a particular patient’s anatomy, rather than an objectively identifiable shape of the claimed implant.
In regard to claims 15-17, Hansson discloses that the surface may be formed with a laser 68 (paragraph [0074]).
In regard to claims 18, 21 and 22, Hansson discloses that the implant may be coated with hydroxyapatite which has a crystalline grain structure (paragraph [0044]).
In regard to claims 25 -27 and 30, the disclosed textured surfaces of Hansson are capable of being formed in a machining process (note paragraph [0039]), the manner in which the surfaces are formed fails to impose any objectively ascertainable structural distinctions from the Hansson implant.
In regard to claim 29, the Hansson implant having the same structural characteristics as that claimed by applicant would inherently be capable of reducing bacterial colonization and gingival downgrowth.
In regard to claim 31, the hydroxyapatite (paragraph [0044]) of Hansson is a mineral.
In regard to claim 32, once implanted the Hansson implant would have traces of natural dentin.
In regard to claim 33, the pits 14, 54 of Hansson meet the broadly claimed “micropore” limitation.
In regard to claim 34, note the undercuts illustrated in Figure 4b.
Claims 1-7, 9, 10, 12-14, 18, 21, 22, and 24-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mandanci et al (US 2018/0318049).
Mandanci et al disclose a dental implant 10 having a first functionalized surface (outer threaded surface 16) having a first macroscale shape of spatial extension (threads 18), having a first microscale surface topography 501 (paragraph [0044])(the manner in which the surface is intended to be formed – “machined” – fails to impose an objectively ascertainable structural distinction) and a first nanoscale surface (paragraph [0046]) that is formed onto the first microscale surface.
In regard to claims 2-7, the Mandanci et al dental implant is capable of being implanted such that the textured threaded surface 16 contacts bone tissue, mucosal tissue, cutaneous and/or periodontal tissue of a mammal. The particular type of tissue that applicant intends for the claimed implant to contact fails to impose any objectively ascertainable structural distinctions from the implant disclosed by Hansson.
In regard to claims 9 and 12, the Mandanci et al implant is a conventional two-piece dental implant with abutment (Figure 10a, 10b).
In regard to claims 13 and 14, the “custom-shaped” limitation fails to impose any objectively ascertainable structural distinction from the implant disclosed by Mandanci et al. Whether or not a Hansson implant “custom” fits the socket or gingival margin of a particular patient depends on a particular patient’s anatomy, rather than an objectively identifiable shape of the claimed implant.
In regard to claims 18, 21 and 22, Mandanci et al disclose that the implant may be coated with hydroxyapatite which has a crystalline grain structure (paragraph [0059]).
In regard to claims 25 -27 and 30, the disclosed textured surfaces of Mandanci et al are capable of being formed in a machining process, the manner in which the surfaces are formed fails to impose any objectively ascertainable structural distinctions from the Mandanci et al implant.
In regard to claim 29, the Mandanci et al implant having the same structural characteristics as that claimed by applicant would inherently be capable of reducing bacterial colonization and gingival downgrowth.
In regard to claim 31, the hydroxyapatite (paragraph [0059]) of Mandanci et al is a mineral.
In regard to claim 32, once implanted the Mandanci et al implant would have traces of natural dentin.
In regard to claim 33, the “irregular pockets of nanoscale tube-like structures” (paragraph [0046]) of Mandanci et al meet the broadly claimed “micropore” limitation.
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 19, 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hansson (US 2011/0306016) in view of McEntire et al (US 2013/0236854).
McEntire et al teach forming dental implants of silicon nitride “in order to reduce or eliminate bacterial colonization” of the implant (note paragraph [0030]). To have constructed the Hansson dental implant of silicon nitride in order to take advantage of its antibacterial properties would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. In regard to claim 36, note the pre-sintering process described at paragraph [0043]. Moreover, it is noted the manner in which applicant intends for the claimed implant to be manufactured fails to impose any objectively ascertainable structural distinctions from Hansson/McEntire et al.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hansson (US 2011/0306016) in view of Ortner et al (US 2021/0236246).
Ortner et al teach forming dental implants of zirconia in order to improve osteointegration of the implant (note paragraph [0018]). To have constructed the Hansson dental implant of silicon nitride in order to take advantage of its osteointegration properties would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hansson (US 2011/0306016) in view of Mochizuki et al (US 2013/0108879).
Mochizuki et al teach that it is desirable to provide a thin carbon film coating of titanium implants in order to improve stability and durability (note paragraphs [0002], [0004], [0006], [0007]). To have provided the Hansson implant with a thin carbon film coating in order to improve the implant’s stability and durability as taught by Mochizuki et al would have been obvious to one of ordinary skill in the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ralph Lewis whose telephone number is (571)272-4712. The examiner can normally be reached Monday-Friday from 9AM-4PM.
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/RALPH A LEWIS/Primary Examiner, Art Unit 3772 (571) 272-4712