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 Objections
Claims 16 and 23 are objected to for relative terminology, namely “predominately.” Applicant’s specification teaches:
0011 e.g. “The first functionalized surface can include a pattern resulting predominately from a laser process, and/or the laser process can be based at least in part on laser interferometry, a laser ablation process, and/or a laser spallation process.”
0042 e.g. “The updated design of the custom-shaped transmucosal portion 162 may have predominately a cross-sectional convex outline devoid of concave or straight outline segments.
Appropriate correction is required.
0044 e.g. “The term “macroscale” in this context shall be understood that the dimensional extension(s) of the defining surface, form or contour elements are predominately greater than about 100 micrometers.”
As interpreted, “predominantly” is quantified as a range having upper and lower limits with respect to the micro and microscale limitations; however, the term is relative with respect to the patterns associated with laser processing and the extent to which laser processing is employed to achieve predominant patterns. Appropriate correction is required for clarifying the extent to which a pattern is predominantly produced from laser processing.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4, 16, 18-20, and 22-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McLean et al. (USPN 12029653).
Claim 1.
McLean teaches a method of manufacturing an implant, the method comprising:
obtaining a specification of the implant, the implant including a first functionalized surface operable to integrate with a first type of mammalian tissue, the first functionalized surface including a first macroscale shape and a first microscale texture formed onto the first macroscale shape, the specification including a description of the first microscale texture (ABSTRACT, claim 1, Col 3 lines 58-67 thru. Col 4 lines 1-5, lines 32-46, Figure 9 e.g. see macroscale and microscale structures for tissue integration: “A medical implant has a textured tissue contact surface comprising a roughened surface that includes a plurality of macroscale and microscale projections and recesses and a plurality of nanostructures on the projections and within the recesses. The nanostructures comprise a plurality of spaced elongated waves, each wave having a crest and a trough. Each wave and recess comprise a plurality of individual polygonal structures, some of which comprise pyramidical-type shapes. The textured tissue contact surface is formed by initially laser ablating a tissue contact surface on the implant with a nanosecond pulsed laser followed by laser ablating the initially ablated surface with a femto-second pulsed laser.
and
machining the first microscale texture based at least in part on the description of the first microscale texture (ABSTRACT, Col 1 lines 31-51, Col 1 lines 63-67, Col 4 lines 4-12, Col 5 lines 8-25 e.g. see laser machining micro and macroscale structures : “The textured tissue contact surface is formed by initially laser ablating a tissue contact surface on the implant with a nanosecond pulsed laser followed by laser ablating the initially ablated surface with a femto-second pulsed laser,” see also “roughened surface 24 is formed by ablating top contact surface 18 a with a pulsed laser in the nanosecond range to create a plurality of projections 26 and recesses 28. Such a process may be performed in accordance with the nanosecond laser devices”)
Claim 2.
The method of claim 1,
wherein,
the specification includes a description of the first macroscale shape (ABSTRACT, Col 1 lines 31-51, Col 1 lines 63-67, Col 5 lines 8-25 e.g. see machining macroscale structures), and
the method includes machining the first macroscale shape based at least in part on the description of the first macroscale shape ((ABSTRACT, Col 1 lines 31-51, Col 1 lines 63-67, Col 5 lines 8-25 e.g. see machining macroscale structures)
Claim 3.
The method of claim 1,
wherein,
the first functionalized surface includes a first nanoscale topography superimposed on the first microscale texture (ABSTRACT, Col 4 lines 46-63, Col 5 lines 53-62, Figure 4: 24 ->26->30 e.g. see nanoscale structures per macro and micro scale portions and recesses)
Claim 4.
The method of claim 3,
wherein,
the specification includes a description of the first nanoscale topography (Figure 4-30, Figure 8, Figure 9) and
the method includes machining the first nanoscale topography based at least in part on the description of the first nanoscale topography ((ABSTRACT, Col 1 lines 31-51, Col 1 lines 63-67, Col 5 lines 8-25))
Claim 16.
The method of claim 1,
wherein,
the first functionalized surface includes a pattern resulting predominately from a laser process (ABSTRACT, claim 7, background of invention) and
the laser process is based at least in part on laser interferometry, a laser ablation process, or a laser spallation process (ABSTRACT, claim 7, background of invention)
Claim 18.
The method of claim 3,
wherein,
the first nanoscale topography is at least partially formed by at least one of grains, crystals, crystallites, polymorphic aggregates, nano pores, or amorphic aggregates included in a substrate material or a coating material of the implant (Col 4 lines 46-60 e.g. see nanostructures 30 on the projections as reading on amorphic aggregates)
Claim 19.
The method of claim 2,
wherein,
the implant is configured for dental implantation (ABSTRACT, supra claim 1)
the description of the first macroscale shape is at least partially representative of an anatomical shape correlating to a shape of a root of a tooth of a pre-identified patient, or to a shape of an alveolar socket of the pre-identified patient (ABSTRACT, Figure 9)
the machining of the first macroscale shape includes a customization process (ABSTRACT, Figure 9, Col 4 lines 13-67) and
the first macroscale shape of the implant at least partially correlates to the anatomical shape (Figure 9)
Claim 20.
The method of claim 2,
wherein,
the implant is configured for dental implantation (Figure 9)
the description of the first macroscale shape is at least partially representative of an anatomical shape correlating to a crown of a pre-identified patient, a transmucosal portion of a tooth of the pre-identified patient, a gingival margin of the pre-identified patient, or a bone crest adjacent an alveolar socket of the pre-identified patient (Figure 9, background of invention, Col 6 lines 6-15 e.g. see jawbone insertion as reading on a gingival margin and/or transmucosal portion, Figure 9 regions corresponding to patient anatomy)
the machining of the first macroscale shape includes a customization process (ABSTRACT, Col 4 lines 31-67) , and
the first macroscale shape of the implant at least partially correlates to the anatomical shape (Figure 9 e.g. see multiple macroscale shapes corresponding to anatomical shapes)
Claim 22.
McLean teaches a method to manufacture an implant, the method comprising:
obtaining a specification of the implant, the implant including a functionalized surface operable to be integrated with a type of mammalian tissue, the functionalized surface including a macroscale shape and a microscale texture superimposed on the macroscale shape, supra claim 1 and a nanoscale topography superimposed on the microscale texture, the specification including a description of the nanoscale topography; supra claim 1, and
machining the nanoscale topography based at least in part on the description of the nanoscale topography, supra claim 1
Claim 23.
The method of claim 22,
wherein,
the nanoscale topography includes a pattern predominately resulting from a laser process, and
the laser process is based at least in part on laser interferometry, a laser ablation process, or a laser spallation process (ABSTRACT, supra claim 16)
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.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over McLean in view over Malshe et al. (PG/PUB 20120276336).
Claim 5.
The method of claim 3 but does not teach the first coating described below. Malshe teaches the first coating described below, further comprising:
applying a first coating, the first coating including the first nanoscale topography (Malshe, ABSTRACT, claim 1, 0004-0005, 0010-0014)
One of ordinary skill in the art before the effective filing date of the claimed invention applying the teachings of Malshe et al., namely applying a first coating, to the teachings of McLean, namely providing a nanoscale structure, would achieve an expected and predictable result via combining said elements using known methods to increase strength. Malshe is in the same field of endeavor and reasonable pertinent to a problem of enhancing strength as described, ABSTRACT, summary of invention.
Claim 6.
The method of claim 5, further comprising:
removing at least a portion of the first coating (Malshe, 0038)
Claims 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over McLean in view over Hansson (PG/PUB 20110306016).
Claim 7.
The method of claim 3 but does not expressly teach the second functionalized surface to be integrated into a second type of tissue described below. Hansson teaches a second functionalized surface to be integrated into a second type of mammalian tissue described below
wherein,
the implant includes a second functionalized surface operable to (e.g. as interpreted, intended use because the implant is capable of being implanted in multiple tissues) be integrated with a second type of mammalian tissue, the second functionalized surface includes a second macroscale shape and a second microscale texture formed onto the second macroscale shape, the specification includes a description of the second microscale texture (Hansson, ABSTRACT, 0009, Figure 1a, 1b, 1c e.g. see second macro structures)
the method includes machining the second microscale texture based at least in part on the description of the second microscale texture (Hansson, 0073-74, Figure 8 e.g. see second microscale structure, supra claim 1 for machining)
the second type of mammalian tissue and the first type of mammalian tissue are different tissue types (Hansson, 0009, 0023-25 e.g. see different tissue type than the tissue type of claim 1)
One of ordinary skill in the art before the effective filing date of the claimed invention applying the teachings of Hanson et al., namely expanding upon the second functionalized surface having a second macroscale and microscale shape for integration into a second type of tissue for a tissue type, to the teachings of McLean, namely providing a first functionalized surface having a first macroscale shape for tissue type, would achieve an expected and predictable result via combining said elements using known methods. The inclusion of the second functionalized surface is configured for insertion into different tissue types. Hansson is in the same field of endeavor with a benefit of enhancing ingrowth as described, summary of invention.
Claim 8.
The method of claim 7,
wherein,
the second microscale texture and the first microscale texture are different texture types (Hannson, 0056, figure 1a, 1b, 1c, supra claim 1 for first microscale texture different than the microscale texture of Hansson)
Claim 9.
The method of claim 7,
wherein,
the specification includes a description of the second macroscale shape (Hansson, Figure 1a, 1b, 1c, 0056-59 e.g. see macro-threads)
the method includes machining the second macroscale shape based at least in part on the description of the second macroscale shape (Hansson, 0073-74, supra claim 1)
Claim 10.
The method of claim 9,
wherein,
the second macroscale shape and the first macroscale shape are different shapes (Hansson, 0056-58, supra claim 1 e.g. see first macro vs second macro threads)
Claim 11.
The method of claim 7,
wherein,
the second functionalized surface includes a second nanoscale topography superimposed on the first microscale texture (Hansson, 0037-38, 0058-59)
Claim 12.
The method of claim 11,
wherein,
the second nanoscale topography and the first nanoscale topography are different nanoscale topographies (supra claim 11 for different nanoscale topographies, supra claim 1)
Claim 13.
The method of claim 11,
wherein,
the specification includes a description of the second nanoscale topography (Hansson, 0058-59, figures 1a-1c), and
the method includes machining the second nanoscale topography based at least in part on the description of the second nanoscale topography (Hansson, 0073-74, supra claim 1)
Claims 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over McLean in view over Hannsson (PG/PUB 20110306016) in view over Malshe et al. (PG/PUB 20120276336).
Claim 14.
The method of claim 11 but does not expressly teach the second coating. Malshe teaches the second coating described below, further comprising:
applying a second coating, the second coating includes the second nanoscale topography (Malshe, 0038-39, 0044-48)
One of ordinary skill in the art before the effective filing date of the claimed invention applying the teachings of Malshe et al., namely applying a first coating, to the teachings of McLean, as modified, namely providing a second nanoscale structure, would achieve an expected and predictable result via combining said elements using known methods to increase strength. Malshe is in the same field of endeavor and reasonable pertinent to a problem of enhancing strength as described, ABSTRACT, summary of invention,
Claim 15.
The method of claim 14, further comprising:
removing at least a portion of the second coating (Malshe, 0038)
Claim 17.
The method of claim 1 but does not expressly teach the chemical vapor deposition. Malshe teaches the chemical vapor deposition.
wherein,
the first functionalized surface includes a coating resulting from a chemical vapor deposition process or a physical vapor deposition process (Malshe, 0038, 0052)
One of ordinary skill in the art before the effective filing date of the claimed invention applying the teachings of Malshe et al., namely applying a first coating, to the teachings of McLean, namely providing a nanoscale structure, would achieve an expected and predictable result via combining said elements using known methods to increase strength. Malshe is in the same field of endeavor and reasonable pertinent to a problem of enhancing strength as described, ABSTRACT, summary of invention,
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over McLean in view Verma et al. (PG/PUB 20110117522).
Claim 21.
The method of claim 20 but does not expressly teach the transmucosal limitations described below. Verma teaches the transmucosal limitation described below.
wherein,
the first macroscale shape includes a transmucosal implant portion (Verma, ABSTRACT, 0037, 0146, 0162)
machining of the first macroscale shape includes forming the transmucosal implant portion with a cross-sectional convex outline devoid of concave or straight outline segments (Verma, ABSTRACT, 0037, 0146, 0162, 0031, supra claim 1 for machining)
One of ordinary skill in the art before the effective filing date of the claimed invention applying the teachings of Verma et al., namely providing a transmucosal portion having the convex outline, to the teachings of McLean, namely providing a dental implant for machining, would achieve an expected and predictable result via combining said elements using known methods to provide a convex shape devoid of concave or straight outline as a matter of design choice in light of the finite and quantifiable shapes for accommodating patient anatomies, as described ABSTRACT.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over McLean in view over Campbell (PG/PUB 20120177694).
Claim 24.
The method of claim 22 but does not expressly teach the molding limitations described below. Campbell teaches the molding limitations described below, further comprising:
forming the nanoscale topography or the microscale texture using a molding tool, the molding tool having a surface in a molding cavity that includes the microscale texture or the nanoscale topography (0146, 0189 e.g. see mold having microscale/nano-scale textures)
One of ordinary skill in the art before the effective filing date of the claimed invention applying the teachings of Campbell et al., namely forming nanoscale structures using a molding tool, to the teachings of McLean, namely providing a dental implant having nanoscale portions, would achieve an expected and predictable result via combining said elements using known methods to provide a dental implant produced via mold having nanoscale features. Campbell is reasonably pertinent to dental surgery applications, as described, 0165, and would commend itself to the production of dental implant described by McLean.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Claim 1 relevancy
20250049539 12029653 20230414368 20230218373 20230165482 20210153982 9848995 20100042226 20200030065 20220265897 20230414368 12029653 20110306016
Claim 5 relevancy
20230218373 20220265897 20210153982 20200030065 20100042226 8684734
Claim 6 relevancy
20240000548 20170156824
Claim 7 relevancy
20230165482 20200030065 9848995
Claim 8 relevancy
20220265897
Claim 21 relevancy
20250090282
Claim 24 relevancy
7622129 20070259427
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/DARRIN D DUNN/Patent Examiner, Art Unit 2117