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 Objections
Claims 1, 8 and 9 are objected to because of the following informalities:
For claim 1, Examiner recommends amending the wording of the paragraphs beginning with “wherein the first suction arm…” and “wherein the second suction arm” to state the following:
wherein the external member is connected to the first/second suction arm between the first end and second end of the first/second suction arm, such that the first/second suction arm extends past the external member
This change makes the claimed limitations easier to follow structurally.
For claims 8-9:
“An other portion” in line 2, should be “another portion”.
“First aperture” in the last line, should be “the first aperture”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6, and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anderson (US 7785105 B2).
Regarding claim 1, Anderson discloses an intra-oral dental appliance (20+30) comprising:
an external member (30);
a flexible and poseable first suction arm (20, left side) (refer to col. 8, lines 23-25, annotated Fig. 8 below); the tubing portion consists of a pliable plastic tube with an embedded compliant metallic wire that can be bent or adapted as needed in use) comprising:
a first end (refer to annotated Fig. 8 below);
a second end (22);
hollow tubing (refer to annotated Fig. 8 below) (refer to col. 8, lines 21-22; standard saliva ejectors exhibit a hollow tube portion); and
a suction tip (22) provided at the second end of the first suction arm (22);
a flexible and poseable second suction arm (20, right side) (refer to col. 8, lines 23-25) comprising:
a first end (refer to annotated Fig. 8 below);
a second end (22);
hollow tubing (refer to annotated Fig. 8 below) (refer to col. 8, lines 21-22);
a suction tip (22) provided at the second end of the second suction arm (22); and
a connector (Y-shaped fitting) connected to the first end of the first suction arm (22) and the first end of the second suction arm (22), the connector (Y-shaped fitting) connectable to a vacuum source (refer to col. 8, lines 17-21; the operatory suction tubing can employ a Y-shaped fitting so that multiple saliva ejectors can be simultaneously used and connected to a central remote vacuum pump),
wherein the second end of the first suction arm (22) is positionable independently from the second end of the second suction arm (22) (refer to col. 8, lines 23-25; each hollow tube is equipped with an embedded metallic wire for independent bending), [[and ]]
wherein the first suction arm (20, left) connected to the external member (30) between the first end (refer to annotated Fig. 9 below) and the second end of the first suction arm (22) so that the first suction arm (20, left) extends past the external member (30) to the second end of the first suction arm (22) and extends further into a mouth of a patient, relative to the external member (30), when the external member (30) is positioned holding open the mouth of the patient (refer to col. 9, lines 22-25; Examiner understands this limitation as intended use; the left and right suction tube notches 34 formed in the tongue shield 33 are wider than the diameter of typical saliva ejector tubing allowing it to enter the interior area of the tongue shield 33; thus, the suction arms (20) are capable of being positioned further into the mouth, relative to the external member (30)), and
wherein the second suction arm (20, right) is connected to the external member (30) between the first end (refer to annotated Fig. 9 below) and the second end of the second suction arm (22) so that the second suction arm (20, right) extends past the external member (30) to the second end of the second suction arm (22) and extends further into the patient's mouth, relative to the external member (30), when the external member (30) is positioned holding open the mouth of the patient (refer to col. 9, lines 22-25)
and wherein the second end of the first suction arm (22) and the second end of the second suction arm (22) are unconnected to the external member (30) (refer to col. 9, lines 19-25, annotated Fig. 9 below; rather than using the stanchions 37, saliva evacuators 20 engaging the tongue shield 33 rely on a mechanical interfit between a notch 34 of a pre-determined width and the tubing portion of a saliva ejector 20).
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Regarding claim 2, Anderson discloses the intra-oral dental appliance of claim 1 (20+30) further comprising:
a first poseable wire integrated into the tubing of the first suction arm (20, left) (refer to col. 8, lines 23-25; a compliant, ductile metallic wire is embedded within the walls of the plastic tubing); and,
a second poseable wire integrated into the tubing of the second suction arm (20, right) (refer to col. 8, lines 23-25).
Regarding claim 3, Anderson discloses the intra-oral dental appliance of claim 1 (20+30) wherein the suction tip (22) provided on the second end of the first suction arm (22) comprises at least one aperture (slit), the at least one aperture (slit) smaller than the cross-sectional area of the tubing of the first suction arm (20) (refer to col. 8, lines 36-37, annotated Fig. 9 above; the head 22 exhibits multiple slits that open into the hollow interior; as demonstrated in annotated Fig. 9 above, the slit is significantly smaller than the cross-sectional area of the tube taken along the length of the tube).
Regarding claim 4, Anderson discloses the intra-oral dental appliance of claim 1 (20+30) wherein the external member (30) comprises:
a first lip retractor (40, left) having a generally arcuate shape with an inner surface (refer to annotated Fig. 1 below) and an outer surface (refer to annotated Fig. 1 below), the outer surface having an open channel (refer to annotated Fig. 1 below) with a substantially semi- circular cross-section for receiving a patient's lips (refer to col. 6, lines 65-66, col. 7, lines 1-5; the present appliance 30 includes two lip retractors 40 arucate in shape with a contour selected to retract the patient's lips outward and rearward);
a second lip retractor (40, right) having a generally arcuate shape with an inner surface (refer to annotated Fig. 1 below) and an outer surface (refer to annotated Fig. 1 below), the outer surface having an open channel (refer to annotated Fig. 1 below) with a substantially semi- circular cross-section for receiving a patient's lips (refer to col. 6, lines 65-66, col. 7, lines 1-5);
a first retractor flange having a front end connected to the first lip retractor (40, left) and extending outwards from the uter surface of the first lip retractor (refer to annotated Fig. 1 below);
a second retractor flange having a front end connected to the second lip retractor (40, right) and extending outwards from the outer surface of the second lip retractor (refer to annotated Fig. 1 below);
a first wing member (42, left) attached to the first lip retractor (40, left) and extending backwards from the inner surface of the first lip retractor (refer to annotated Fig. 1 below) (refer to col. 7, lines 61-62; two opposing side ears 42 extend laterally outward from the front edges of the lip retractors 40);
a second wing member (42) attached to the second lip retractor (40, right) and extending backwards from the inner surface of the second lip retractor (refer to annotated Fig. 1 below); and
a flexible resilient member (35+36) connected between the first retractor flange and the second retractor flange (refer to annotated Fig. 1 below), the flexible resilient member (35+36) biasing the first lip retractor (40, left) and the second lip retractor (40, right) apart (refer to col. 6, lines 34-35, 45-50; the cheek distention arms 36 are generally adjacent to the cross bar 35, subject to bending loads, flexural loads and torsional forces to distend a patient’s cheeks; thus, these structures (35+36) form a flexible member capable of withstanding flexural loads).
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Regarding claim 6, Anderson discloses an external member (30) for keeping a patient's mouth open (refer to col. 6, lines 38-42; the device 30 has left and right cheek distention arms 36 that extend laterally outward and forward from opposing rear portions of the tongue shield 33 to distend a patient's cheeks away from the molars and vestibules), the external member (30) comprising:
a first lip retractor (40, left) having a generally arcuate shape with an inner surface (refer to annotated Fig. 1 below) and an outer surface (refer to annotated Fig. 1 below), the outer surface having an open channel (refer to annotated Fig. 1 below) with a substantially semi- circular cross-section for receiving a patient's lips (refer to col. 6, lines 65-66, col. 7, lines 1-5; the present appliance 30 includes two lip retractors 40 arucate in shape with a contour selected to retract the patient's lips outward and rearward);
a second lip retractor (40, right) having a generally arcuate shape with an inner surface (refer to annotated Fig. 1 below) and an outer surface (refer to annotated Fig. 1 below), the outer surface having an open channel (refer to annotated Fig. 1 below) with a substantially semi- circular cross-section for receiving a patient's lips (refer to col. 6, lines 65-66, col. 7, lines 1-5);
a first retractor flange having a front end connected to the first lip retractor (40, left) and extending outwards from the uter surface of the first lip retractor (refer to annotated Fig. 1 below);
a second retractor flange having a front end connected to the second lip retractor (40, right) and extending outwards from the outer surface of the second lip retractor (refer to annotated Fig. 1 below);
a first wing member (42, left) attached to the first lip retractor (40, left) and extending backwards from the inner surface of the first lip retractor (refer to annotated Fig. 1 below) (refer to col. 7, lines 61-62; two opposing side ears 42 extend laterally outward from the front edges of the lip retractors 40);
a second wing member (42) attached to the second lip retractor (40, right) and extending backwards from the inner surface of the second lip retractor (refer to annotated Fig. 1 below); and
a flexible resilient member (35+36) connected between the first retractor flange and the second retractor flange (refer to annotated Fig. 1 below), the flexible resilient member (35+36) biasing the first lip retractor (40, left) and the second lip retractor (40, right) apart (refer to col. 6, lines 34-35, 45-50; the cheek distention arms 36 are generally adjacent to the cross bar 35, subject to bending loads, flexural loads and torsional forces to distend a patient’s cheeks; thus, these structures (35+36) form a flexible member capable of withstanding flexural loads);
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a first aperture sized to accept tubing and passing through at least one of: the first lip retractor (40, left); and, the first retractor flange (refer to annotated Fig. 1 below) (refer to col. 9, lines 50-55; Examiner is interpreting the first aperture as the hole or opening in the external member through which the tube passes; the vertical guides 43 are aligned with the stanchions 37, forming an aligned opening or aperture that the suction tube 20 passes through, passing through the distal end of the lip retractor and the retractor flange)
a first opening [in]] passing through the inner surface sized to allow tubing to pass through the first opening, the first opening leading into the first aperture (refer to annotated Figs. 1, 5, 8 below);
a second aperture sized to accept tubing and passing through at least one of: the second lip retractor (40, right); and, the second retractor flange (refer to annotated Fig. 1 below) (refer to col. 9, lines 50-55); and
a second opening [[in]] passing through the inner surface of the sized to allow tubing to pass through the second opening, the second opening leading into the second aperture (refer to annotated Figs. 1, 5, 8 below) (the inner surface extends along the retractor from the flange, to the distal, lower end of the retractor; first and second openings are formed along the edges of the inner surface of the retractors, passing through the inner surface to allow the tubing to pass through the external member; as demonstrated in annotated Fig. 1 below, these openings lead into the aligned aperture the tube passes through).
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Regarding claim 11, Anderson discloses the external member of claim 6 (30) wherein the first aperture (refer to annotated Fig. 1 below) has an upper portion extending above the first opening and a lower portion extending below the first opening (refer to annotated Fig. 1 below) (the portion of the aperture formed by the stanchions 37 forms the upper portion, the portion of the aperture formed by the vertical guides forms the lower portion).
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Regarding claim 12, Anderson discloses the external member of claim 11 (30) wherein the upper portion is sized to pressure fit tubing in the upper portion and the lower portion is sized to pressure fit tubing in the lower portion (refer to col. 9, lines 50-55; Examiner understands “pressure fitting” as securing the tubing, consistent with Applicant’s description on page 18, lines 11-13 of the specification; the upper and lower portions are sized and configured to hold or secure the tubing in a desired position).
Claim(s) 6-10 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cohen et al. (US 4019255 A), herein Cohen.
Regarding claim 6, Cohen discloses an external member (15) for keeping a patient's mouth open (refer to col. 2, lines 12-15, Fig. 1; a dental apparatus 15 retracts the cheeks to expose the patient’s teeth), the external member (15) comprising:
a first lip retractor (17, left) having a generally arcuate shape with an inner surface and an outer surface (refer to annotated Fig. 1 below), the outer surface having an open channel with a substantially semi- circular cross-section for receiving a patient's lips (refer to annotated Fig. 1 below) (refer to col. 2, lines 17-22, 33-35; each retractor element 16 includes on its inner end a hook part 17 which may have a transversely extending channel-like portion 18 of U-shaped cross section that is arcuate or bowed; the side walls 21 of each hook part engage the lips);
a second lip retractor (17, right) having a generally arcuate shape with an inner surface and an outer surface (refer to annotated Fig. 1 below), the outer surface having an open channel with a substantially semi- circular cross-section for receiving a patient's lips (refer to annotated Fig. 1 below) (refer to col. 2, lines 17-22, 33-35);
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a first retractor flange (25, left) having a front end connected to the first lip retractor (17, left) and extending outwards from the outer surface of the first lip retractor (refer to annotated Fig. 2 below) (refer to col. 2, lines 34-37, col. 3, lines 26-29; a generally straight extension or shank 25 extends from the hooked part outer side walls 21, 22, outwardly away from the mouth; of note- Examiner is considering the flange 25 as continuous with the retractor 17, such that the tube 36 is centered on the boundary formed on the side walls 21,22 between the flange 17 and retractor 25);
a second retractor flange (25, right) having a front end connected to the second lip retractor (17, right) and extending outwards from the outer surface of the second lip retractor (refer to annotated Fig. 2 below) (refer to col. 2, lines 34-37);
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a first wing member (refer to annotated Fig. 2 below) attached to the first lip retractor (17, left) and extending backwards from the inner surface of the first lip retractor (refer to annotated Fig. 2 below);
a second wing member (refer to annotated Fig. 2 below) attached to the second lip retractor (17, right) and extending backwards from the inner surface of the second lip retractor (refer to annotated Fig. 2 below);
a flexible resilient member (27) connected between the first retractor flange (25, left) and the second retractor flange (25, right), the flexible resilient member (27) biasing the first lip retractor (17, left) and the second lip retractor (17, right) apart (refer to col. 2, lines 37-41; the outer end of each shank 25 terminates in a transverse or forwardly projecting lug 26 providing connector means for connecting respective retractor elements 16 to opposite ends of a resiliently contractile element 27);
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a first aperture sized to accept tubing and passing through at least one of: the first lip retractor (17, left); and, the first retractor flange (25, right) (refer to annotated Fig. 2 below);
a first opening [[in]] passing through the inner surface sized to allow tubing to pass through the first opening, the first opening leading into the first aperture (refer to annotated Fig. 2 below);
a second aperture sized to accept tubing and passing through at least one of: the second lip retractor (17, right); and, the second retractor flange (25, right); and
a second opening [[in]] passing through the inner surface of the sized to allow tubing to pass through the second opening, the second opening leading into the second aperture (refer to annotated Fig. 2 below) (Examiner understands the first and second openings as leading into to the first aperture, consistent with page 17, lines 4-12 of the specification and Fig. 9; the first and second openings are shown as the openings in the inner surface, leading into the first and second apertures, which pass through the front and back walls of the first lip retractor).
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Regarding claim 7, Cohen discloses the external member of claim 6 (15) wherein the first lip retractor (17, left) further comprises: a front wall; and, a back wall (refer to annotated Fig. 2 from claim 1 above), and the second lip retractor (17, right) further comprises: a front wall; and, a back wall refer to annotated Fig. 2 from claim 6 above), and wherein the first aperture passes through both the front wall and the back wall of the first lip retractor and the second aperture passes through both the front wall and the back wall of the second lip retractor (refer to annotated Fig. 2 from claim 6 above).
Regarding claim 8, Cohen discloses the external member of claim 7 (15) wherein a portion of the first aperture passes through the front wall of the first lip retractor (refer to annotated Fig. 2 from claim 1 above)and an other portion of first aperture passes through the first retractor flange (25, left) (refer to annotated Fig. 2 from claim 6 above) (refer to col. 2, lines 34-36, col. 3, lines 25-30; Examiner is considering the flange 25 as continuous with the retractor 17, such that the tube 36 is centered on the boundary formed on the side walls 21,22 between the flange 17 and retractor; thus, a portion of the aperture extends through both the retractor and the adjacent flange).
Regarding claim 9, Cohen discloses the external member of claim 7 (15) wherein a portion of the first aperture passes through the back wall of the first lip retractor and an other portion of first aperture passes through the first wing member (refer to annotated Fig. 2 from claim 6 above).
Regarding claim 10, Cohen discloses the external member of claim 6 (15) wherein the first aperture passes through the first retractor flange (25, left) and the first aperture passes through the first wing member (refer to annotated Fig. 2 from claim 6 above) (refer to col. 2, lines 34-36, col. 3, lines 25-30; Examiner is considering the flange 25 as continuous with the retractor 17, such that the tube 36 is centered on the boundary formed on the side walls 21,22 between the flange 17 and retractor; thus, the aperture extends through the retractor flange).
Allowable Subject Matter
The prior art of record fails to teach or reasonably suggest an external member for keeping a patient’s mouth open that includes first and second lip retractors, first and second flanges, first and second wing members, a flexible member connected between the first and second flanges, first and second apertures extending through the first and second flanges and more particularly first and second channels provided in the first and second wing members with an outer wall of the channel extending further than an inner wall all as explicitly set forth in pending claim 5. As claim 5 has been rewritten to over the prior 35 U.S.C. 112 rejection and typographical error, claim 5 is allowed.
Response to Arguments
The outstanding drawing objection of the black and white photographs is withdrawn in view of the newly submitted drawing amendment.
The outstanding 35 U.S.C. 112(b) rejections of claims 2, 4-6, and 7-12 are withdrawn in view of the newly submitted claim amendments.
Applicant's arguments filed 06/16/2026 have been fully considered but they are not persuasive.
In response to the argument that Anderson does not anticipate claim 1, due to the stanchions (37) of the appliance (30), Examiner points to Fig. 9 and col. 9, lines 15-22, which disclose the use of notches (34) to engage the tubing portions of the saliva ejectors (20) as an alternative to using the stanchions (37). This embodiment is also referenced in the above rejection. Further, as also stated by the Applicant, Anderson teaches that the saliva ejectors (20) can be employed in several positions and combinations (refer to col. 9, lines 41-45); however, Anderson does not explicitly teach in any of the referenced passages by Applicant that the ejectors (20) cannot extend past the appliance (30) to perform the intended use of suctioning saliva gathered in the oral cavity. Rather, Anderson teaches using the available notches (34) to position the tubing in whichever position is desired.
In response to the argument that Cohen does not teach an opening passing through an inner surface, Examiner points to the above rejection. The opening for tubing as taught by Cohen (refer to annotated figures above) passes through the inner surface, as the surface is only the top layer of the retractor structure. Further, this opening leads to an aperture which is shown as allowing the tube (36) to extend through the retractor element (17), the same function as Applicant’s device. Examiner recommends Applicant amend the claim language for the limitations for the opening and apertures to make it clear as to where the openings end and the apertures begin. Currently, the claim language only requires the openings as leading into the apertures, which are another opening, and it is up to subjective interpretation as to where two openings leading into one another start and end.
Additionally, the rejection of claim 6 now also relies on a new grounds of rejection by Anderson.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Adriena J Webb Lyttle whose telephone number is (571)270-7639. The examiner can normally be reached Mon - Fri 10:00-7:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Edelmira Bosques can be reached at (571) 270-5614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADRIENA J WEBB LYTTLE/Examiner, Art Unit 3772
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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