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 § 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, 4, 8, 14 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Park (WO 2013187645) in view of Garcia Martin et al. (WO 2015162329) and Dinkelacker (EP 1440669) and in further view of Ishiwata (WO 2018088389).
Regarding Claim 1, Park teaches an implant structure comprising a fixture that acts as an artificial tooth root (implant fixture 1), wherein the fixture includes:
a cylindrical bone contact portion (outer lower section La) having a first outer peripheral surface on which a thread is formed (Figure 1 shows thread on implant fixture 1) and
a gingival contact portion (outer upper section Ua) having a second outer peripheral surface and disposed on the bone contact portion (Figure 1 shows that Ua is on the bone contact portion as it abuts outer lower section La), and
the first outer peripheral surface and the second outer peripheral surface include a plurality of protrusions (Figure 1 includes insets showing the surface roughness which is formed by parts of the surfaces sticking out or protruding),
wherein an arithmetic mean roughness (Ra) value of the second outer peripheral surface (surface of outer upper section Ua) is in a range of 1.0 µm to 5.0 µm (translation page 5 middle paragraph teaches the upper section, which is the gingival contact portion, has a surface roughness of 0.2-1.0 µm, overlapping and therefore anticipating the claimed range of the instant application at 1.0 µm),
wherein an arithmetic mean roughness (Ra) value of the first outer peripheral surface is in a range of 0.5 um to 3.0 um (translation page 5 middle paragraph teaches the lower section, which is the bone contact portion, has a surface roughness of 1.5-3.0 µm on the top part of that section and a surface roughness of 0.2-1.0 µm on the bottom part of that section, both of these ranges significantly or completely overlap the claimed range).
Park teaches that the gingiva contact portion, or upper portion, of the implant having such a surface roughness to prevent bacterial growth and proliferation, providing an anti-bacterial surface (“Advantageous Effects” paragraph). Park teaches that the bone contact portion has specified surface roughness in order to increase bone adherence to the implant structure (“Advantageous Effects” paragraph). Park also teaches that the antibacterial portion and the bone adhering portion of the implant have different surface structures (see insets in Figure 1).
Park specifies the surface roughness of the different parts of the implant fixture, but does not specify other details of the surface. Therefore, Park does not explicitly teach the protrusions on the surfaces are nano-protrusions, the dimensions of such protrusions, or the protrusions being formed by surface-treating the structure with a femtosecond laser.
However, Garcia Martin, in the same field of endeavor of dental implants (bottom of translation page 4; translation page 5 two lines above “Detailed Description of the Invention”), teaches implants with titanium surfaces with antibacterial properties (abstract) and teaches that antibacterial surfaces, such as the second outer peripheral surface of the gingiva contacting portion, have nano-protrusions with a shape that promotes killing of bacteria present on the surface (first paragraph under “Detailed Description of the Invention”), and the nano-protrusions have a width of 10 to 1000 nm (space between nano-protrusions is 50-150 nm; special definition of width in instant specification is the same as space in Garcia Martin; second bullet point under “Explanation of the Invention”) and an aspect ratio of 1:1 to 1:50 (second bullet point under “Explanation of the Invention” teaches the diameter of the nano-protrusions is 30 to 100 nm and the height is 100 to 300 nm, therefore the aspect ratio of the taught nano-protrusions ranges from 100:100 to 30:300, or 1:1 to 1:10; nano-protrusions in Figures 1 and 5 are shown as being much taller than they are wide therefore the ratio of the nano-protrusions shown in figures is 1:>1).
Additionally, Dinkelacker, in the same field of endeavor of bone implants (abstract), teaches a titanium implant with a surface to promote osseointegration (first paragraph in “Summary of the invention”) with nano-protrusions (nanostructure 81 with crests 82 and lacunae 86), that have a width of 10nm to 1000nm (distance between ridges can range from 100-500 nm; translation page 6 bottom paragraph) and an aspect ratio of 1000:1 to 1:1 (depth/height of protrusions is described as 10-500 nm and distance between ridges is described as 100-500nm; based on Figure 8 of nanostructure 81, the width of the base of each crest is the same as the distance between the tops and also the nanostructures appear at least as wide as they are tall; therefore aspect ratio of horizontal distance:height for nano-protrusions described is 500:10 to 100:500 or 5:1 to 1:5, this range overlaps and therefore anticipates the claimed range of the instant application).
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 dental implant taught by Park to include the protrusions of the first peripheral surface (intended to be osseointegrative) being nano-protrusions with the width and aspect ratio taught by Dinkelacker and the protrusions of the second peripheral surface (intended to be antibacterial) being nano-protrusions with the width and aspect ratio taught by Garcia Martin, while maintaining the surface roughness taught by Park as being effective for osseointegration or antibacterial surfaces. This is a simple combination of material properties known to be effective for osseointegration or antibacterial surfaces, and the exact necessary nano-protrusion dimensions, such as height, diameter, wall slope of protrusions, or other dimensions to form the required width, aspect ratio, and surface roughness, can be determined through routine calculations and experimentation.
The combination of the dental implant of Park with the nano-protrusion parameters of Dinkelacker for the first outer peripheral surface (for osseointegration) and the nano-protrusion parameters of Garcia Martin for the second outer peripheral surface (for anti-bacterial properties) further teach wherein the aspect ratio of the nano- protrusions included in the first outer peripheral surface (Dinkelacker translation page 6 bottom paragraph teach the nano-protrusions being at least as wide as they are tall) is different from the aspect ratio of the nano-protrusions included in the second outer peripheral surface (Garcia Martin Figures 1 and 5 and second bullet point under “Explanation of the Invention” teach the nano-protrusions being much taller than they are wide).
Dinkelacker further teaches that surface structures on titanium implants can be formed by blasting, etching, sputtering, or treatment with a laser (translation: abstract, page 3 bottom paragraph, page 6 top paragraph). Therefore it would have been obvious to try surface-treating with a laser to create the nano-protrusions. And one might be motivated to try a laser over blasting or etching for surface treatment due to the high level of control that is possible when using a laser system, or to prevent contaminant remaining on the surface such as from etching or blasting (translation page 4 second paragraph). However Dinkelacker does not specify the use of a femtosecond laser.
Ishiwata, in the same field of endeavor of implants with nanostructured surface (abstract), teaches the use of a femtosecond laser for creating (translation bottom of page 12 into top of page 13 teaches use of femtosecond laser to create microvilli, and that such process is the same for microvilli 81 on titanium and 41 on ceramic) a nanostructured surface (living tissue surface 70 with microvilli 81, which differ from microvilli 41 only in material) on a titanium dental implant (translation pages 10 and 12 teaches that dental implant 3 is a titanium alloy implant). Ishiwata further teaches where the surface treatment is irradiating of a femtosecond laser beam in a linear-type and grid-type pattern (Figures 7 and 8; translation page 9 teaches about the small grooves and large grooves being formed by scanning with the laser). While Ishiwata does not specifically state the laser intensity as being 1-5 W, it does teach shapes created by the femtosecond laser on the implant can be changed by adjusting the width of the laser, the scanning speed, the laser light output and the number of times an area is irradiated. Therefore the laser intensity would be chosen based on routine experimentation to achieve the desired final result. The limitation to the parameters of the laser irradiation of the surface are product-by-process limitations, and the implant created by the processes taught by Ishiwata would be the same as the implant created as claimed, as a variety of parameters can be varied in laser irradiation to result in the same final product.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create the surface structures of the dental implant of Park modified with the more specific nano-protrusion parameters of Garcia Martin and Dinkelacker using a femtosecond laser as taught by Ishiwata. Dinkelacker teaches a laser as a potential surface treatment, therefore it would be obvious to try a laser. Dinkelacker does not provide further specifics of the laser for the surface treatment, therefore it would be obvious to use the femtosecond laser taught by Ishiwata as it is known to be able to form nano-protrusions on titanium dental implants.
Regarding Claim 4, Park, Garcia Martin, Dinkelacker, and Ishiwata teach the implant structure of claim 1, as presented above. Garcia Martin further teaches wherein the nano-protrusions have blunt ends (Figures 1A-C and 5).
Regarding Claim 8, Park, Garcia Martin, Dinkelacker, and Ishiwata teach the implant structure of claim 1, as presented above. Park further teaches wherein the implant structure includes at least one material selected from titanium, or titanium alloy (first line under “Advantageous Effect”). Garcia Martin, Dinkelacker, and Ishiwata also teach at least the surface of the implant structure being titanium or a titanium alloy.
Regarding Claim 14, Park teaches an implant structure comprising a fixture that acts as an artificial tooth root (implant fixture 1), wherein the fixture includes:
a cylindrical bone contact portion (outer lower section La) including a first outer peripheral surface on which a thread is formed (Figure 1 shows thread on implant fixture 1), the first outer peripheral surface is a bone formation facilitation region (“Advantageous Effects” paragraph) including a plurality of protrusions (Figure 1 includes insets showing the surface roughness which is formed by parts of the surfaces sticking out or protruding), and
an antibacterial activity facilitation region (outer upper section Ua; taught as being antibacterial in “Advantageous Effects” paragraph) having a second outer peripheral surface that is located on the bone formation facilitation region (Figure 1 shows that Ua is on the bone contact portion as it abuts outer lower section La) and includes a plurality of protrusions (Figure 1 includes insets showing the surface roughness which is formed by parts of the surfaces sticking out or protruding),
wherein an arithmetic mean roughness (Ra) value of the second outer peripheral surface (surface of outer upper section Ua) is in a range of 1.0 µm to 5.0 µm (translation page 5 middle paragraph teaches the upper section, which is the gingival contact portion, has a surface roughness of 0.2-1.0 µm, overlapping and therefore anticipating the claimed range of the instant application at 1.0 µm),
wherein an arithmetic mean roughness (Ra) value of the first outer peripheral surface is in a range of 0.5 µm to 3.0 µm (translation page 5 middle paragraph teaches the lower section, which is the bone contact portion, has a surface roughness of 1.5-3.0 µm on the top part of that section and a surface roughness of 0.2-1.0 µm on the bottom part of that section, both of these ranges significantly or completely overlap the claimed range);
wherein the antibacterial activity facilitation region (Ua) is formed in the range of 0.1 mm to 3.0 mm (the upper section is the top 2.5 mm of the implant; see “Tech Solution”) in a direction from a top end of the bone contact portion to the bone formation facilitation region (La).
Park specifies the surface roughness of the different parts of the implant fixture, but does not specify other details of the surface. Therefore, Park does not explicitly teach the protrusions on the surfaces are nano-protrusions, the dimensions of such protrusions, or the protrusions being formed by surface-treating the structure with a femtosecond laser.
However, Garcia Martin, in the same field of endeavor of dental implants (bottom of translation page 4; translation page 5 two lines above “Detailed Description of the Invention”), teaches implants with titanium surfaces with antibacterial properties (abstract) and teaches the antibacterial surfaces having nano-protrusions with a shape that promotes killing of bacteria present on the surface (first paragraph under “Detailed Description of the Invention”), and the nano-protrusions have a width of 10 to 1000 nm (space between nano-protrusions is 50-150 nm; special definition of width in instant specification is the same as space in Garcia Martin; second bullet point under “Explanation of the Invention”) and an aspect ratio of 1:1 to 1:50 (second bullet point under “Explanation of the Invention” teaches the diameter of the nano-protrusions is 30 to 100 nm and the height is 100 to 300 nm, therefore the aspect ratio of the taught nano-protrusions ranges from 100:100 to 30:300, or 1:1 to 1:10; nano-protrusions in Figures 1 and 5 are shown as being much taller than they are wide therefore the ratio of the nano-protrusions shown in figures is 1:>1).
Additionally, Dinkelacker, in the same field of endeavor of bone implants (abstract), teaches a titanium implant with a surface to promote bone formation along the implant (first paragraph in “Summary of the invention”) with nano-protrusions (nanostructure 81 with crests 82 and lacunae 86), that have a width of 10nm to 1000nm (distance between ridges can range from 100-500 nm; translation page 6 bottom paragraph) and an aspect ratio of 1000:1 to 1:1 (depth/height of protrusions is described as 10-500 nm and distance between ridges is described as 100-500nm; therefore aspect ratio of horizontal distance:height for nano-protrusions described is 500:10 to 100:500 or 5:1 to 1:5, this range overlaps and therefore anticipates the claimed range of the instant application, but furthermore based on Figure 8, the fact that the depth can be much smaller than the width, and that the structures are intended to be rounded rather than sharp).
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 dental implant taught by Park to include the protrusions of the bone formation facilitation region being nano-protrusions with the width and aspect ratio taught by Dinkelacker and the protrusions of the antibacterial activity facilitation region being nano-protrusions with the width and aspect ratio taught by Garcia Martin, while maintaining the surface roughness taught by Park as being effective for osseointegration or antibacterial surfaces. This is a simple combination of material properties known to be effective for osseointegration or antibacterial surfaces, and the exact necessary nano-protrusion dimensions, such as height, diameter, wall slope of protrusions, or other dimensions to form the required width, aspect ratio, and surface roughness, can be determined through routine calculations and experimentation.
The combination of the dental implant of Park with the nano-protrusion parameters of Dinkelacker for the first outer peripheral surface (for osseointegration) and the nano-protrusion parameters of Garcia Martin for the second outer peripheral surface (for anti-bacterial properties) further teach wherein the aspect ratio of the nano- protrusions included in the first outer peripheral surface (Dinkelacker translation page 6 bottom paragraph teach the nano-protrusions being at least as wide as they are tall) is different from the aspect ratio of the nano-protrusions included in the second outer peripheral surface (Garcia Martin Figures 1 and 5 and second bullet point under “Explanation of the Invention” teach the nano-protrusions being much taller than they are wide).
Dinkelacker further teaches that surface structures on titanium implants can be formed by blasting, etching, sputtering, or treatment with a laser (translation: abstract, page 3 bottom paragraph, page 6 top paragraph). Therefore it would have been obvious to try surface-treating with a laser to create the nano-protrusions. And one might be motivated to try a laser over blasting or etching for surface treatment due to the high level of control that is possible when using a laser system, or to prevent contaminant remaining on the surface such as from etching or blasting (translation page 4 second paragraph teaches such contaminations are possible). However Dinkelacker does not specify the use of a femtosecond laser.
Ishiwata, in the same field of endeavor of implants with nanostructured surface (abstract), teaches the use of a femtosecond laser for creating (translation bottom of page 12 into top of page 13 teaches use of femtosecond laser to create microvilli, and that such process is the same for microvilli 81 on titanium and 41 on ceramic) a nanostructured surface (living tissue surface 70 with microvilli 81, which differ from microvilli 41 only in material) on a titanium dental implant (translation pages 10 and 12 teaches that dental implant 3 is a titanium alloy implant). Ishiwata further teaches where the surface treatment is irradiating of a femtosecond laser beam in a linear-type and grid-type pattern (Figures 7 and 8; translation page 9 teaches about the small grooves and large grooves being formed by scanning with the laser). While Ishiwata does not specifically state the laser intensity as being 1-5 W, it does teach shapes created by the femtosecond laser on the implant can be changed by adjusting the width of the laser, the scanning speed, the laser light output and the number of times an area is irradiated. Therefore the laser intensity would be chosen based on routine experimentation to achieve the desired final result. The limitation to the parameters of the laser irradiation of the surface are product-by-process limitations, and the implant created by the processes taught by Ishiwata would be the same as the implant created as claimed, as a variety of parameters can be varied in laser irradiation to result in the same final product.
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to create the surface structures of the dental implant of Park modified with the more specific nano-protrusion parameters of Garcia Martin and Dinkelacker using a femtosecond laser as taught by Ishiwata. Dinkelacker teaches a laser as a potential surface treatment, therefore it would be obvious to try a laser. Dinkelacker does not provide further specifics of the laser for the surface treatment, therefore it would be obvious to use the femtosecond laser taught by Ishiwata as it is known to be able to form nano-protrusions on titanium dental implants.
Regarding Claim 16, Park, Garcia Martin, Dinkelacker, and Ishiwata teach the implant structure of claim 14, as presented above. Garcia Martin further teaches wherein the nano-protrusions of the antibacterial activity facilitation region have blunt ends (Figures 1A-C and 5).
Regarding Claim 17, Park, Garcia Martin, Dinkelacker, and Ishiwata teach the implant structure of claim 14, as presented above. Park further teaches wherein the implant structure includes at least one material selected from titanium, or titanium alloy (first line under “Advantageous Effect”), though Garcia Martin, Dinkelacker, and Ishiwata also teach at least the surface of the implant structure being titanium or a titanium alloy as well.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant argues that the claimed invention “not a mere combination of individual elements from cited documents. Rather it is an organic combination of features that achieves a synergistic effect.” However, combining known individual elements which individually achieve known results (antibacterial properties or osseointegrative properties achieved due to specific nanoprotrusion aspect ratios and specific surface roughness) is not the basis for patentability based on an assertion that combining them achieved synergistic effects.
Applicant argues that while Park teaches a dental implant with different upper and lower surface properties, including roughness in the claimed ranges, it does not teach nano-protrusions but rather a more random surface. The examiner agrees that Park does not teach the details of the nano-protrusions, but Park does teach that surface roughness is known to affect the osseointegrative and antibacterial properties of titanium dental implants. Therefore it would be obvious to control the surface roughness to be within ranges known to have the desired effects. Surface roughness is a result of nano-protrusions and other surface structures which may not be specifically recited in the claims. Given that Park does not teach more specific details on the nano-structures on the surface, it would be obvious to look elsewhere for additional parameters known to achieve the desired effects.
Applicant argues that while the implant of Garcia Martin discloses the claimed aspect ratio for antibacterial nano-protrusions, it has a much lower roughness than claimed due to the method of creating the nano-protrusions. The rejection does not rely on Garcia Martin to teach the method of creating the nano-protrusions, but rather relies on Garcia Martin to teach nano-protrusion dimensions known to achieve antibacterial results. As stated above, surface roughness depends on more than just nano-protrusion shape, therefore it would be obvious to utilize both a surface roughness and nano-protrusion dimensions known to achieve antibacterial results and the combination of the two could be achieved through routine optimization and testing of surface properties.
Applicant argues that Dinkelacker does not teach the claimed aspect ratio because patent drawings are not precise scales. Examiner assumes this argument is directed to Dinkelacker not teaching the claimed aspect ratio for osseointegration surfaces, though the argument states antibacterial region. The examiner agrees that the patent drawing of Dinkelacker cannot be relied upon to teach precise scales. However the claimed aspect ratios are not precise, rather requiring the nanoprotrusions to be at least as wide as they are tall (claimed aspect ratio for first outer surface to promote osseointegration is 1000:1 to 1:1). Nano-protrusions taught by Dinkelacker with a depth (or height) of 10-500 nm and a width of 100-500 nm are typically at least as wide as they are tall, more likely wider than they are tall.
All together these references teach the components of the claimed dental implant in such a way that the implant as claimed would be obvious. Therefore while no single reference teaches the complete combination, Park teaches that a combination is desirable but is silent to some details and the combination of references teaches those details as known to achieve the desired properties of being antibacterial or osseointegrative.
Additionally, the claimed ranges for aspect ratio and width of nano-protrusions are large and the applicant does not appear to place criticality on the ranges, stating in paragraphs [10] to [18] of the instant specification that the ranges are “about” or “may be” before providing ranges.
Applicant’s arguments regarding Ishiwata not disclosing the specific laser intensity and irradiation patterns are not convincing as these limitations are product-by-process limitations. Ishiwata teaches that it is known and obvious to fabricate desired specific surface patterns on dental implants using a femtosecond laser. The precise laser intensity and irradiation pattern used would not be known by observing the final product as multiple variables can be optimized for laser irradiation systems to achieve the same final product.
Conclusion
THIS ACTION IS MADE FINAL. 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 Jennifer P. Connell whose telephone number is (703)756-1169. The examiner can normally be reached Monday - Thursday 9 am - 3 pm ET.
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/JENNIFER P CONNELL/ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
Prosecution Insights