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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/23/2026 has been entered.
Allowable Subject Matter
The indicated allowability of claims 10 and 13-15 are withdrawn in view of the newly discovered references IP et al (US 2019/0110786). Rejections based on the newly cited reference(s) follow.
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 1-2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Lesser (US 2017/0000586) in view of Kilcher et al (US 2006/0234187) and Fowler Jr (US 6,190,312)
Regarding claim 1, Lesser discloses an assistant tool for dental treatment (lip protector 10) comprising an inner frame (perimeter 16 and portions of lip guard 12 and 14 that is positioned on the interior side of the lip, pointed out as the upper lip guard rim 46 and the lower lip guard rim 48) configured to be inserted into an oral cavity (see figure 1 and 2), and a retraction member (outer lip portion of the upper and lower lip guards 12/14 see figures 1-2) coupled to the inner frame to retract tissues around the oral cavity (see figure 1-2 and par 25 which discloses the guards exposing the teeth by forcing the upper and lower lip out of the way and is coupled to the inner frame by being unitary with the lip guard rim), wherein the assistant tool (10) comprises:
a holder (tube 18) provided on at least one of the inner frame and the retraction member to fix a suction (see figures 1-4, with the holder located on the perimeter 16, see par 25 and fixes tube 22), and is configured such that one side of the suction is portioned in a predetermined portion in the oral cavity while maintaining the oral cavity of a patient in an open state (see par 25 and figure 1 which discloses positioning the tube in a desired position to enable a dental procedure), and
a portion of the inner frame (inner portion of the upper lip guard rim 46), configured to be in contact with a periphery of a frenum in the oral cavity (interpreted as functional language wherein the lip guard rim 46 is positioned in contact with the lip and frenum, as seen in figure 2 and par 27),
the inner frame includes a first section in configured to be in contact with a periphery of the frenum in the oral cavity (see annotated figure 4, wherein the interior portion of the lip guard is capable of being in contact with a periphery of frenum as seen in figure 2), a second section configured to be in contact with a periphery of buccal mucosa (see annotated figure 4, wherein a portion of the perimeter 16 is capable of being positioned adjacent to the buccal mucosa as seen in figure 2), and a third section that is between the first section and the second section and is configured to be in contact with a periphery of soft tissue and hard tissue of the oral cavity (see annotated figure 4, wherein a portion of the perimeter 16 which connects with the lip guard is in contact with both the dentition and the mucosal tissue as seen in figure 2),
wherein the second section is extended long in a lateral direction (see annotated figure 4, where the second section extends laterally into the mouth as seen in figure 2), and the third section has a curved shape in which an absolute value of a slope is same or varies from the first section to the second section (see annotated figure 4).
Lesser fails to disclose a portion of the frame includes an indention formed in a shape dented toward a central portion of the oral cavity, the indention is configured to be seated in the frenum of the oral cavity when the inner frame is inserted into the oral cavity,
wherein the holder is provided on the inner frame or the retraction member so as to slide along the inner frame or the retraction member, thereby allowing a suction to be positioned at a first position according to an anatomical shape in the oral cavity and a situation of the procedure, and wherein the first position indicates a position at which a suction operation can be performed by the suction without disturbing the procedure.
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Annotated figure 4
Kilcher teaches a portion of a frame ((lip retractor 30) includes an indention (apertures 52/54) formed in a shape dented toward a central portion of the oral cavity (see figure 5), the indention (52/54) is configured to be seated in the frenum of the oral cavity when the inner frame is inserted into the oral cavity (par 26 and figure 8) for the purpose of reducing or eliminating pressure on the frenulum when the retractor is installed in the patient’s mouth (par 26).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Lesser to have the portion of the frame includes an indentation formed in a shape dented toward a central portion of the oral cavity as taught by Kilcher for the purpose of reducing or eliminating pressure on the frenulum when the retractor is installed in the patient’s mouth.
Fowler teaches a holder (snap on clip 42) provided on a frame or retraction member (see figures 9-10, attached to the frame member 36) so as to slide along the frame or the retraction member (col 7, lines 18-20) for the purpose of enabling adjustment to the position of the holder while preventing accidental disengagement (col 7, lines 17-18).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Lesser/Kilcher to have the holder provided on the inner frame or retraction member to slide along the inner frame or the retraction member as taught by Fowler for the purpose of enabling adjustment to the position of the holder while preventing accidental disengagement
The limitation “thereby allowing a suction to be positioned at a first position according to an anatomical shape in the oral cavity and a situation of the procedure, and wherein the first position indicates a position at which a suction operation can be performed by the suction without disturbing the procedure” is considered intended use/functional language achievable by the disclosed prior art, where the holder of Lesser holds a tool, such as a suction (see figure 1) and the teaching of Fowler allowing for positioning of the holder and suction into a desired position.
Regarding claim 2, Lesser further discloses the inner frame (16) and the retraction member (12/14) are formed in a shape in which top and bottom are symmetrical or asymmetrical (see figure 4, appear to be symmetrical) and left and right are symmetrical or asymmetrical (see figure 4, appears to be symmetrical).
Regarding claim 5, Lesser discloses the holder (10) is configured to fix the suction such that an end of the suction is positioned in the oral cavity where water is collected (in view of figures 1-2, which discloses the end positioned within the mouth and includes a tongue retractor positioned in the mouth around the treatment area).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Lesser in view of Kilcher et al and Fowler Jr as applied to claim above, and further in view of Battan (WO 2013/057670).
Regarding claim 4, Lesser/Kilcher/Fowler discloses the claimed invention as set forth above in claim 1. Lesser further teaches the suction includes a suction tip (retractor 30) and a suction tube (22), but fails to disclose the suction tube has an elastic modulus in a range of 0.01 to 185 Mpa.
However, Battan teaches a suction tube (pipe 10, which has a use as a suction cannula 7 for dental use, see page 10, lines 24-25), where the tube (10/7) has an elastic modulus in the range of 0.01 to 185 Mpa (where the preferred admixture B used for pipe 10 gives a modulus of elasticity of 150Mpa, see page 12, lines 10-12 and 15) for the purpose of providing sufficient mechanical strength with a high level of flexibility and resistance to kinking when bent (page 2, lines 5-7)
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Lesser/Kilcher/Fowler to have the suction tube has an elastic modulus in a range of 0.01 to 185 Mpa as taught by Battan for the purpose of providing sufficient mechanical strength with a high level of flexibility and resistance to kinking when bent.
Claims 10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Horvath (US 2004/0097795) in view of IP et al (US 2019/0110786) and Anderson (US 2007/0148619)
Regarding claim 10, Horvath discloses an assistant tool for dental treatment (see figures 1-3) comprising
an inner frame (inner tension frame 1) configured to be inserted into an oral cavity (see figures 3-4), and
a retraction member (outer tension frame 2 and film like means 3) coupled to the inner frame to retract tissues around the oral cavity (see figure 1 and figure 3, par 40 discloses the application of tension force on the lips and cheeks),
wherein the assistant tool comprises a holder provided on at least one of the inner frame and the retraction member to fix a suction (par 13 discloses the tension frame being composed of several parts joined together and at least one of the frame parts can be attachable to a saliva device and can be constructed as a small tube provided with holes),
the retraction member (2/3) includes:
an outer frame (2) configured so as to be mounted on an outside of the oral cavity (figure 3 and 4, shows the outer frame positioned outside the lip 4); and
a cover member (3) in the form of a film having elasticity or superelasticity (par 16 discloses the film-like means being elastically stretchable), with one side coupled to the inner frame and the other side coupled to the outer frame (see figures 1-4).
The limitation “the assistant tool for dental treatment is configured such that, even when it is mounted, the assistant tool allows the oral cavity of a patient to be open, and also allows an opening process of widening a gap between upper and lower teeth and a closing process of narrowing the gap between the upper and lower teeth to be performed”, is interpreted as a functional limitation that is capable of being achieved in view of the disclosed structure of Horvath. Specifically, a closed and open design wherein the tension frames are flexible and sized for the specific patient, see par 18, 21 and 47.
Horvath fails to disclose wherein the holder is provided on the inner frame or the retraction member so as to be moved and a force required to separate the suction tube from the holder is greater than a force required to fix the suction tube to the holder.
Ip teaches a holder (coupling mechanism 375) provided on an inner frame (upper ring 350) so as to be moved (par 69-70 discloses the coupling mechanism being snap fit and therefore movable to a desired portion).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Horvath to have the holder is provided on the inner frame or the retraction member so as to be moved as taught by Ip for the purpose of enabling removable and positioning of the holder to the oral cavity in a desired position.
Anderson teaches a force required to separate the suction tube (20) from a holder is greater than a force required to fix the suction tube to the holder (par 60 discloses magnets as one of the connectors which would require more force to separate than to fix or attach).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Horvath/Ip to have a force required to separate the suction tube from the holder is greater than a force required to fix the suction tube to the holder as taught by Anderson for the purpose of securely attaching a standard saliva ejector to the holder.
The limitations “wherein one side of the suction to be positioned at a normal position on a predetermined portion in the oral cavity ” and “allowing the suction to be positioned at a first position according to an anatomical shape in the oral cavity and a situation of the procedure, wherein the first position indicates a position at which a suction operation can be performed by the suction without disturbing the procedure, wherein the suction includes a suction tip and a suction tube” are intended use or functional limitations which are achievable by the prior art of record in view of the disclosure of the holder of Ip which allows for placement at a desired position see par 69-70.
Regarding claim 13, Anderson further teaches a holder (stanchion 37) is provided on an inner frame (distending arms 36), an outer holder (two vertical guides 43) is provided in the outer frame (lip retractor 40), and the suction tube (suction tube 20) is fixed to the holder and the outer holder (see figure 11) for the purpose of positioning the saliva ejector in a desired position during dental procedure (par 63).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing fate of the claimed invention to modify Horvath/Ip/Anderson to have the holder positioned on the inner frame, an outer holder is provided on the outer frame, and the suction tube is fixed to the holder and the outer holder as taught by Anderson for the purpose of positioning the saliva ejector in a desired position during dental procedure.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Horvath in view of Ip et al and Anderson as applied to claim 10 above, and further in view of Muller et al (US 2017/0196659).
Regarding claim14, Horvath/Ip/Anderson fail to disclose the inner frame includes a first section configured to be in contact with a periphery of the frenum in the oral cavity, a second section configured to be in contact with a periphery of buccal mucosa, and a third section that is between the first section and the second section and is configured to be in contact with a periphery of soft tissue and hard tissue of the oral cavity, and between a highest point of the first section and a lowest point of the second section, there is the same height or a predetermined height difference such that a surface including a closed curve or an open curve forming the inner frame is formed as a curved surface.
Muller teaches an inner frame (14) includes a first section (recess 20/18) configured to be in contact with a periphery of frenum in the oral cavity (par 35 discloses the proximity to a frenula extension), a second section (lateral areas 34/36) configured to be in contact with a periphery of buccal mucosa (see figure 1, where the spacing between the frenum and the cheek would result in contact between the lateral areas when applied to the mouth), and a third section (comfort projections 28/30) that is between the first section and the second section (see figure 1) and is configured to be in contact with a periphery of soft tissue and hard tissue of the oral cavity (when attached the space between the frenula and the periphery would include the hard and soft tissue of the mouth), and between a highest point of the first section (20) and a lowest point of the second section (34/36), there is the same height or a predetermined height difference (see figure 1, there is a height difference which is predetermined based on the positioning of the device) such that a surface including a closed curve or an open curve forming the inner frame is formed as a curved surface (see figure 1) for the purpose of enabling adjustability in size and position in any suitable manner (par 53).
Therefore, it would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify Horvath/Ip/Anderson to have the inner frame includes a first section configured to be in contact with a periphery of the frenum in the oral cavity, a second section configured to be in contact with a periphery of buccal mucosa, and a third section that is between the first section and the second section and is configured to be in contact with a periphery of soft tissue and hard tissue of the oral cavity, and between a highest point of the first section and a lowest point of the second section, there is the same height or a predetermined height difference such that a surface including a closed curve or an open curve forming the inner frame is formed as a curved surface as taught by Muller for the purpose of enabling adjustability in size and position in any suitable manner.
Regarding claim 15, Muller further teaches the second section (34/36) is extended long in a lateral direction (see figure 1), and the inner frame (14) is configured in a peanut shape (see figure 1) in which portions in contact with peripheries of frenum in the oral cavity are dented into a concave shape (recesses 18/20, see paragraph 35), for the reasons set forth above.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/S.N.B./Examiner, Art Unit 3772
/HEIDI M EIDE/Primary Examiner, Art Unit 3772
4/3/2026
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