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.
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Yamane et al. (US 2016/0000523) in view of Grant (US 2018/0200024).
Regarding claim 1, Yamane teaches a nozzle element for a dental treatment device (Figs 1-6; nozzle 2A), in particular for a dental treatment device intended for a subgingival cleaning of at least a part of a surface of a root of a tooth (abstract; par 7 discloses the use of the nozzle for subgingival cleaning, which includes the subgingival tooth surface and gums), comprising:
a basic body (nozzle body 202) being elongated in a longitudinal direction (see annotated figure 1 below; the length of the basic body in a longitudinal direction is clearly at least more than 5 times greater than a diameter of the basic body measured in a direction perpendicular to the longitudinal direction; see applicant’s definition of elongated in the instant application specification, page 4 lines 18-21) and configured to be introduced at least partially into a periodontal pocket (abstract and par 7; the nozzle 2A is configured to be used for subgingival cleaning in a tiny gap between a subgingival tooth surface and a gum, which is the periodontal pocket),
a first feed channel (channel 21) for transporting a powder - gas - mixture (Par 27 discloses “The nozzle 2A has channel 21 and injection port 210 thereof for transferring the mixture of air and powder”), wherein said first feed channel (21) is incorporated inside the basic body (see Figs 1-3; channel 21 is inside nozzle body 202),
a first outlet opening (injection port 210) of said first feed channel (21) in an end region of the elongated basic body (see Figs 1-5; injection port 210 is in an end region of the basic body 202; see annotated Figure 2) for ejecting the powder - gas - mixture (Par 27, “The nozzle 2A has channel 21 and injection port 210 thereof for transferring the mixture of air and powder” ), wherein said first outlet opening is preferably configured for a lateral ejection of the powder - gas - mixture in a first ejection direction being slanted relative to the longitudinal direction (see Fig 5; see Par 29, the ejection of the air and powder mixture is slanted relative to the longitudinal direction),
wherein the nozzle element is configured for providing at least a part of at least one pressure relief channel (groove 24, par 30 discloses the groove 24 extending axially from a location near the notch 23 toward the connector portion 201, and functions as a guide for allowing the mixture injected through the injection port 210 to flow toward the connector portion out of the subgingival area, thus relieving pressure which is provided by the insertion of the mixture injected)
wherein the nozzle element provides at least a part of the at least one pressure relief channel (24) extends to the end of the basic body (see annotated figure 3, which defines an end region of the basic body and figure 1 and par 30 which shows the groove extends axially to a terminal point of the base body near the notch 23, and therefore is considered extending to the end of the basic body as seen in annotated figure 3).
Yamane discloses the nozzle is formed thin and flat (par 7), but fails to disclose the basic body is formed of any specific material such as an elastic material to be deformed slightly in the periodontal pocket, the pressure relief channel is open at front side of the basic body facing a periodontal pocket in utilization and wherein using the pressure relief channel, a pressure in the periodontal pocket can be successfully decreased by 30%.
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Annotated figure 1
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However, Grant teaches a basic body (tip body 110) formed of an elastic material that deforms slightly in the periodontal pocket (par 31-32 discloses the tip body 110 being made of a thermoplastic polyurethane and polyethylene, wherein the material of the prongs 120 which are polyurethane and polyethylene being flexible) for the purpose of allowing the insertion/guiding body into the interspatial/interproximal and subgingival locations while maintaining sufficient structure to enable the general shape of the basic body (par 27).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Yamane to have the basic body be formed from an elastic and deformable material as taught by Grant for the purpose of allowing the insertion/guiding body into the interspatial/interproximal and subgingival locations while maintaining sufficient structure to enable the general shape of the basic body.
Additionally, Grant teaches a basic body (tip body 110) having a pressure relief channel (external groove or channel 116) is open at front side of the basic body facing a periodontal pocket in utilization (see figure 1 and par 38 which discloses from a front surface opening via the space between prongs 120) for the purpose of venting away ejected material away from the tip to prevent any buildup of pressure (par 38).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify the basic body pressure relief channel of Yamane to have an opening at a front side of the basic body facing a periodontal pocket in utilization as taught by Grant for the purpose of venting away ejected material away from the tip to prevent any buildup of pressure.
Regarding the limitation “to be deformed slightly in the periodontal pocket” and “using the pressure relief channel, a pressure in the periodontal pocket can be successfully decreased by 30%” is interpreted as functional limitation/intended use of the claimed invention. With regard to the statement of intended use and other functional statements, they do not impose any structural limitations on the claims distinguishable over Yamane/Grant which is capable of being used as claimed if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In the instant case, Yamane discloses the nozzle element being inserted into the subgingival space near the surface of the tooth (par 9), the modification of Grant enables the nozzle element to be deformable as it is composed of elastic material (par 31-32), Grant discloses the flexibility of the material of the tip being sufficient to allow some bending or twisting within the interspatial/interproximal or subgingival location while allowing a return to the original shape (par 27) and Grant also discloses open front side pressure relief channel (groves 116) provide additional channels through which the ejected material can vent away from the tip 100 to prevent any build-up of pressure within subgingival/interspatial spaces (par 38). Wherein the decrease in pressure is interpreted as an associated feature of the claimed structure, which is taught by the prior art. Therefore, the invention of Yamane/Grant is capable of performing the intended use/functional limitation.
Regarding claim 2, Yamane further discloses wherein the part of the at least one pressure relief channel (24) is formed (i) at the end region of the basic body (see figure 1 and 4), along the length of the basic body and has a length equal to or greater than the length of the periodontal pocket in which it is inserted (where the length of the groove 24 is large enough to have the mixture guided out of the gingival pocket towards the connector 210 as recited in par 30) and/or (iii) by the shape of an outer surface of the basic body, the shape comprising a groove extending to the end region of the basic body (see figure 1 and 4).
Regarding claim 3, Yamane further discloses a second feed channel (channel 22; see annotated Figure 2 above) for transporting a fluid (par 27 discloses channel 22 being used to transfer water) is incorporated inside the basic body (see Fig. 3; channel 22 is within nozzle body 202), wherein the second feed channel has a second outlet opening (injection port 220) for ejecting the fluid in a second ejection direction at a front /distal side of the basic body (see Figs 1-4; par 36 discloses injection port 220 is at a distal side of the basic body and ejects water in a different direction than the ejection of the air-powder mixture) in the end region of the basic body (see Fig 4; par 31).
Regarding claim 4, Yamane discloses the basic body (202) is formed by a first tube forming the first channel (See annotated Figure 3 below) and a second tube forming the second channel (see annotated Figure 3 below).
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Regarding claim 5, Yamane discloses the basic body (202) has at least a first side wall and optionally a second or more side wall being opposite to the first side wall in a direction perpendicular to the longitudinal direction (see annotated Figure 4 below; the first and second side walls are opposite to each other in a direction perpendicular to the longitudinal axis), wherein the first side wall and/or the second side wall has at least two contact points for contacting a surface of the tooth during its utilization (see annotated Figure 5 below; par 37 nozzle 2A contacts the tooth surface during its utilization; it is inherent that the nozzle has more than one / at least two contact points, as the nozzle can be rotated and/or moved within the subgingival area such that different parts of the nozzle can contact the tooth surface), wherein the first side wall has a first recess between two contact points (see annotated Figure 5 below; the recess is groove 24), bounded by the first side wall and a thought first line between the two contact points at the first side wall (see annotated Figure 5 below), and/or the second side wall has a second recess between two contact points (see annotated Figure 5 below; the recess is groove 24), bounded by the second side wall and a thought second straight line between the two contact points at the second side wall (see annotated Figure 5 below).
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Regarding claim 6, Yamane/Grant disclose the claimed invention as set forth above in claim 5. Yamane further teaches wherein a first surface area of the first wall is assigned to the first recess (see annotated Figure 6 below) and a second surface area of the second wall is assigned to the second recess (see annotated Figure 6 below).
Yamane fails to explicitly teach wherein a ratio of a sum of the first surface and the second surface to a total surface of the nozzle element has a value between 1 and 20 %.
Yamane discloses that the grooves 24 allow material to flow supragingival (par 30), effectively removing excess material from the worksite at the tooth and causing less pressure to build up in the subgingival space from the build-up of mixture. Grooves 24 are also capable of allowing air that is within the periodontal pocket to flow out of the pocket, meeting the applicant’s definition of a pressure relief channel in the instant specification (page 4 lines 7-9). The figures of Yamane reveal that the grooves 24 make up a percentage of the total surface area of the entire nozzle element (Figs 1,5-6). From these drawings of Yamane, it also appears that the ratio of the grooves’ surface area to a total surface area of the nozzle element is a small amount, at least 1% or greater. Also, it is inherent that the bigger the grooves 24, the greater the flow of material across them, and thus the effect of pressure relief is greater; the grooves perform the function of pressure relief, and the size of the grooves directly correlates with that function. The size of the grooves is a result effective variable such that changing the size of the grooves changes the amount of material that is flowed away from the subgingival worksite, which affects the amount of pressure within the subgingival area and thus the work efficiency of the nozzle. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the Yamane nozzle to have a ratio within the claimed range, as it involves only adjusting the dimension of a disclosed component which would directly impact its function to channel flow of material therethrough.
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Regarding claim 7, Yamane/Grant discloses the claimed invention as set forth above in claim 5.
Yamane further discloses wherein a first surface of the first wall is assigned to the first recess (see annotated Figure 6 above) and a second or more surfaces of the second or more wall is assigned to the second or more recesses (see annotated Figure 6 above).
Yamane fails to explicitly teach wherein the sum of the surfaces of the recesses is between 0.01 to 1 mm.
However, Yamane does teach that commercial nozzles for use in general dental or medical institutions have dimensions such as 1.62 mm width and 0.78 mm thickness (par 3). The figures of Yamane reveal that the grooves 24 are sized such that roughly half of a side wall constitutes a groove (Figs 1,5-6). With width being the distance between the two side walls and the thickness being the length of a side wall, it is feasible that the sum of the surfaces of the recesses falls into a range between 0.1 and 1 mm^2. Further, it is inherent that the by modifying the thickness of a nozzle (e.g., the length of the side wall), the size of the grooves (and resultingly the surface area of a groove) within the side wall will also be modified. The size of the grooves is a result effective variable such that changing the size of the grooves changes the amount of material that is flowed away from the subgingival worksite, which affects the amount of pressure within the subgingival area and thus the work efficiency of the nozzle. Adjustment of the thickness of a nozzle directly correlates to the function of the grooves; one of ordinary skill in the art would have had a reasonable expectation of success in modifying the thickness of the nozzle in order to size the pressure relief grooves such that they function at a desired level, as it involves only adjusting the dimension of a disclosed component.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of the nozzle of Yamane such that the sum of the surfaces of the recesses falls into the claimed range of 0.01 to 1mm^2 in order to provide the desired amount of backflow and as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” /n re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 8, Yamane teaches wherein a distance between the first side wall and the second side wall measured in a direction parallel to the first ejection direction is modulated along a direction being perpendicular to the first ejection direction and the longitudinal direction (Fig 6; see annotated Figure 7 below; the distances between the first side wall and the second side wall are clearly modulated, such that the distances change in length due to the grooves in the side walls; where the grooves are, there is a smaller distance between the side walls compared to the ends of the side walls. Starting at the top of annotated Figure 7, the distance between the side walls decreases moving down towards the grooves, and then increase once again once passed the grooves, and as such the distances are modulated).
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Regarding claim 9, Yamane teaches the nozzle element of claim 5.
Yamane further discloses wherein in a cross-section perpendicular to the longitudinal direction the basic body has a minimal distance between the first side wall and the second side wall (Fig 6; the minimal distance is the distance between the deepest part of the recess of first side wall and the deepest part of the recess of the second side wall; see annotated Figure 8 below).
Yamane fails to explicitly teach wherein the minimal distance between the first side wall and the second side wall is at least 0.2 mm.
However, Yamane does teach that commercial nozzles for use in general dental or medical institutions have dimensions such as 1.62 mm width and 0.78 mm thickness (par 3; width is the distance between two side walls; a width of 1.62mm meets the claim limitation of a distance being at least 0.2mm). Based on Figure 6 of Yamane, if the distance between the two side walls at a location that is not the minimal distance is 1.62mm, it is obvious that the minimal distance will be less than 1.62mm, but still greater than 0.2mm. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the nozzle of Yamane to have a minimal distance within the claimed range, as it only involves adjusting the dimensions of a disclosed component.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the nozzle of Yamane to have a minimal distance between the first side wall and the second side wall of at least 0.2mm.
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Regarding claim 10, Yamane further discloses the basic body (202) is formed integrally (Figs 1-3,5; nozzle body 202 is clearly formed of one piece, and as such is formed integrally).
Regarding claim 11, Yamane further discloses the nozzle element (2A) has an attachment section (connector portion 201) for attaching the nozzle element to a hand piece or an adapter of the hand piece (par 27).
Regarding claim 12, Yamane further discloses the attachment section (201) is configured such that a longitudinal extension of the hand piece is orientated to be tilted relative to a first side wall about an angle less than 45° (see annotated Figure 9 below; the connector portion 201 receives the part of the hand piece 1 that extends in a longitudinal direction, the longitudinal extension of the hand piece and the first side wall are tilted about an angle less than 45°, such that the angle is about 0°; the longitudinal extension of the handpiece and the first side wall are clearly parallel to each other and thus the angle between them is 0).
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Regarding claim 13, Yamane further discloses the first side wall and the second wall mainly extend parallel to each other along the longitudinal direction over a length of the basic body (see Figs 1-6 which shows the first side wall and second side wall are parallel to each other along the longitudinal direction), wherein the pressure relief channel extends at least over the length of the basic body (Figs 1 and 5; groove 24 extends over the length of the basic body).
Regarding claim 14, Yamane discloses the first recess and/or the second recess is arranged between the first channel and the second channel (Fig 6; see annotated Figure 5; the first and second recesses are clearly arranged between the first and second channels, which are the rectangles in Fig 6 / annotated Figure 5).
Response to Arguments
Applicant's arguments filed 3/19/2026 have been fully considered but they are not persuasive.
Applicant argues on page 6-7, that the prior art fails to disclose “a pressure in the periodontal pocket can be successfully decreased by 30%”, and that this feature relies on the technical interaction between the elasticity of the basic body, structural dimensioning of the body such as the ratio of the sum of recess surface areas to the total surface area of the nozzle is dimensioned between 1%-20%, providing sufficient structural integrity to enable the relief channels to maintain sufficient cross section to discharge air. The examiner does not find this argument persuasive. It is noted that the features upon which applicant relies (i.e., the dimensions of the recess surface area and the total surface area of the nozzle ) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The applicant disclosure of the range of dimensions needed by the recessed surface relative to the nozzle surfaces is not positively recited, and while mentioned in the specification the disclosed limitation of the 30% pressure reduction in the periodontal pocket is interpreted as the result of intended use of the claimed structure.
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.
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/S.N.B./ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
4/30/2026
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