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 § 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.
Claims 1 and 10 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.
Claim 1 recites a broad limitation in lines 4-5 “a holder provided on at least one of the inner frame and the retraction member to fix a suction” and then a more narrow in lines 24-25 recites “the holder is provided in the inner frame, an outer holder is provided in the retraction member”, which is a narrower statement than provided earlier in the claim; A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, the holder is interpreted as being provided on the inner frame.
Claim 1 recites in lines 4-5 “a holder provided on at least one of the inner frame and the retraction member to fix a suction” it is unclear if the suction is a part of the assistant tool or if “to fix” is an operation of the holder. Please provide clarification. For the purpose of examination, the suction is interpreted as a structural element of the assistant tool.
Claim 10 recites a broad limitation in lines 4-5 “a holder provided on at least one of the inner frame and the retraction member to fix a suction” and then a more narrow in lines 23-24 recites “the holder is provided in the inner frame, an outer holder is provided in the retraction member”, which is a narrower statement than provided earlier in the claim; A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purpose of examination, the holder is interpreted as being provided on the inner frame.
Claim 1 recites in lines 4-5 “a holder provided on at least one of the inner frame and the retraction member to fix a suction” it is unclear if the suction is a part of the assistant tool or if “to fix” is an operation of the holder. Please provide clarification. For the purpose of examination, the suction is interpreted as a structural element of the assistant tool.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Lesser (US 2017/0000586) in view of Kilcher (US 2006/0234187), Fowler et al (US 6,190,312), Anderson (US 2007/0148619) and Battan (WO 2013/057670).
In regard to claim 1, Lesser discloses an assistant tool for dental treatment (lip protector 10) comprising an inner frame (perimeter 16 that is positioned on the interior side of the lip) configured to be inserted into an oral cavity (see figure 1 and 2), and a retraction member (upper and lower lip guards 12/14) coupled to the inner frame (see figures 3-4) 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 comprises:
a holder (tube 18) provided on the inner frame 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),
a portion of the inner frame (inner portion of the upper lip guard rim 46 on perimeter 16), 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 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),
wherein 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),
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).
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, wherein an outer holder is provided in the retraction member, wherein the retraction member includes first to fourth retraction members, wherein the first and second retraction members are formed in a curved plate structure extending from the inner frame toward the outside of the oral cavity, and configured to retract the patient's lips, wherein the third and fourth retraction members are formed in a curved plate structure extending from the inner frame toward the outside of the oral cavity, configured to retract the patient's inner cheeks, wherein the suction includes a suction tip and a suction tube, the suction tube comprises a metal wire serving as a reinforcing material, and the suction tube has an elastic modulus in a range of 50 to 100 MPa.
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Annotated figure 4
Kilcher discloses an assistant tool for dental treatment comprising an inner frame (connecting elements 44, 46, 48, 50) configured to be inserted into an oral cavity (see figures 7-9), and a retraction member (upper and lower lip shields 32, 34 and cheek portions 36, 38) coupled to the inner frame to retract tissues around the oral cavity (see figures 7-9) teaches a portion of the inner frame (portion adjacent to the side edge 82) configured to be in contact with a periphery of a frenum in the oral cavity (see figure 8) includes an indentation (apertures 52/54) formed in a shape dented toward a central portion of the oral cavity (see figures 5 and 8), and the indentation is configured to be seated in the frenum of the oral cavity when the inner frame is inserted into the oral cavity (see figures 7-9), wherein the inner frame includes the indentation (see figure 5), wherein the inner frame and the retraction member are formed in a shape in which top and bottom are symmetrical and left and right are symmetrical (see figure 5 and 7), wherein the retraction member includes first to fourth retraction members (32, 34, 36, 38),wherein the first and second retraction members(32/34) are formed in a curved plate structure (see figure 5, defines channel 80) extending from the inner frame toward the outside of the oral cavity, and configured to retract the patient's lips (see figures 7-9), wherein the third and fourth retraction members (36 and 38) are formed in a curved plate structure extending from the inner frame toward the outside of the oral cavity (see figures 5-9), configured to retract the patient's inner cheeks (figures 7) 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 modify Lesser to have 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 inner frame and the retraction member are formed in a shape in which top and bottom are symmetrical and left and right are symmetrical, wherein the retraction member includes first to fourth retraction members, wherein the first and second retraction members are formed in a curved plate structure extending from the inner frame toward the outside of the oral cavity, and configured to retract the patient's lips, wherein the third and fourth retraction members are formed in a curved plate structure extending from the inner frame toward the outside of the oral cavity, configured to retract the patient's inner cheeks as taught by Kilcher for the purpose of reducing or eliminating pressure on the frenulum when retracting.
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.
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) and wherein the suction includes a suction tip (22) and a suction tube (20), the suction tube comprises a metal wire serving as a reinforcing material (par 57), 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, at the time of applicant’s invention to modify Lesser to have an outer holder is provided in the retraction member and the suction includes a suction tip and a suction tube, the suction tube comprises a metal wire serving as a reinforcing material as taught by Anderson for the purpose of positioning the saliva ejector in a desired position during dental procedure.
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 50 to 150 Mpa (where the preferred admixture B used for pipe 10 gives a modulus of elasticity of 50-150 Mpa, 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), however the prior art fails toe explicitly disclose the modulus of elasticity between 50-100.
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/Muller/Battan to have the suction tube has an elastic modulus in a range of 50 to 150 Mpa to 50-100 Mpa since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990), for the purpose of providing sufficient mechanical strength with a high level of flexibility and resistance to kinking when bent.. Further, applicants appear to have placed no criticality on the claimed range, see page 16, lines 7-13 discloses the range of the elastic modulus in the range of 0.01 to 185 Mpa and the range of the prior art falls within.
Claims 10 is rejected under 35 U.S.C. 103 as being unpatentable over Horvath (US 2004/0097795) in view of IP et al (US 2019/0110786), Anderson , Muller et al (US 2017/0196659) and Battan et al
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 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, 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, the suction includes a suction tip and a suction tube, 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, the holder is provided in the inner frame, an outer holder is provided in the outer frame, and the suction tube is fixed to the holder and the outer holder,
wherein 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, wherein the second section is extended long in a lateral direction, wherein the inner frame is configured in a peanut shape in which portions are configured to be in contact with peripheries of frenum in the oral cavity are dented into a concave shape, and the suction tube comprises a metal wire serving as a reinforcing material, and the suction tube has an elastic modulus in a range of 50 to 100 MPa.
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.
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.
Anderson teaches the suction includes a suction tip (22) and a suction tube (20), the suction tube comprises a metal wire serving as a reinforcing material (par 57), 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), 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 date of the claimed invention to modify Horvath to have the suction includes a suction tip and a suction tube, 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, the holder is provided in the inner frame, an outer holder is provided in the outer frame, and the suction tube is fixed to the holder and the outer holder, the suction tube comprises a metal wire serving as a reinforcing material, as taught by Anderson for the purpose of positioning the saliva ejector in a desired position during dental procedure.
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),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) and 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 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 to have wherein 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, wherein the second section is extended long in a lateral direction, wherein the inner frame is configured in a peanut shape in which portions are configured to be in contact with peripheries of frenum in the oral cavity are dented into a concave shape as taught by Muller for the purpose of enabling adjustability in size and position within the mouth of the user.
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 50 to 150 Mpa (where the preferred admixture B used for pipe 10 gives a modulus of elasticity of 50-150 Mpa, 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), however the prior art fails to explicitly disclose the modulus of elasticity between 50-100.
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/Muller/Battan to have the suction tube has an elastic modulus in a range of 50 to 150 Mpa to 50-100 Mpa since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990), for the purpose of providing sufficient mechanical strength with a high level of flexibility and resistance to kinking when bent. Further, applicants appear to have placed no criticality on the claimed range, see page 16, lines 7-13 discloses the range of the elastic modulus in the range of 0.01 to 185 Mpa and the range of the prior art falls within.
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 to the combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's arguments filed 7/7/2026 have been fully considered but they are not persuasive. Page 7-8 applicant argues that the prior art fails to disclose a metal wire serving as a reinforcing material, However Anderson discloses the suction having a metallic embedded wire as set forth above. Additionally, applicants argue that the claimed range of 50-100 MPa provides unexpected results with support found in the specification, the examiner does not find this argument persuasive. On page 16 of the specification, in summary the range of elastic modulus to provide a desired hold and limit discomfort is provided as not exceeding 185 MPa or between the range of 0.01-185 MPa, which Battan discloses values within this range as desirable for similar reasons. The table discloses specific values 50 and 100 having minimal discomfort, but as stated above the provided range of operation is given as between 0.01 and 185 Mpa.
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.
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/S.N.B./ Examiner, Art Unit 3772
/HEIDI M EIDE/ Primary Examiner, Art Unit 3772
9/29/2026
