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 .
Specification
The use of the terms Ateva® 4030AC, Ateva® 2820AG or Ateva® 1807EG, which are trade names or a marks used in commerce, has been noted in this application. See pg. 9 lines 16-24 of the Instant Application’s Specification for Ateva® 4030AC, Ateva® 2820AG or Ateva® 1807EG, where the use of a proper symbol is included indicating the use of commerce following the term.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: ‘112’ of Figure 4. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 13 objected to because of the following informalities: Claim 13, line 2 recites Luerlock ® which is the improper spelling of the registered trademark Luer-Lok®. For the purpose of examination, the limitation is being treated as generic luer lock. Appropriate correction is required.
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.
Claim 12 is rejected under 35 U.S.C. 112(b), 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 12 contains the trademarks/trade names: Ateva ® 4030AC. Ateva ®2820AG, Ateva ®1807EG. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982) and MPEP 2173.05(u).
The claim scope is uncertain since the trademark or trade name cannot be used properly to describe any particular material or product. In fact, the value of a trademark would be lost to the extent that it became the generic name of a product, rather than used as an identification of a source or origin of a product. Thus, the use of a trademark or trade name in a claim to describe a material or product would not only render a claim indefinite, but would also constitute an improper use of the trademark or trade name.
A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In claim 12, the trademark/trade names, Ateva® 4030AC, Ateva® 2820AG or Ateva® 1807EG, are used to identify/describe the material ethylene-vinyl acetate (EVA).
For the purposes of examination, it will be interpreted for claim 12 that the thermoplastic material is made of ethylene-vinyl acetate (EVA), and for claim 13, that the fitting of the tubular connection is a Luer-lock type fitting.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 7, 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2021082162 A1) and as evidenced by Suchan (US 20060228675 A1).
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Figure 1: annotated Figures 5-6 of Wei.
Regarding claim 1, Wei discloses a mouthpiece for providing a free upper airway during procedural sedation (Figure 1 above; ‘100’ is a mouthpiece for providing free upper airway during procedural sedation, Wei [0005]) the mouthpiece comprising:
a body comprising an airway channel extending from a first end of the body to a second end of the body (Figure 1 above; where the body of the mouthpiece comprises an airway channel ‘11’, that extends from the first end ‘13’ of the body to the second end ‘14’ of the body);
wherein the first end is an anterior end of the body and the second end is a posterior end of the body (Figure 1 above; where the first end ‘13’ is the front end of the body (anterior) and the second end ‘14’ is the back end of the body that interfaces with the user (posterior));
a first stop supported by the body configured to control the insertion depth of the body into the oral cavity of a patient (Figure 1 above; where ‘15’ is a first stop, Wei [0032]; where the first stop pushes the patient’s upper teeth or upper lip backward to keep the jaws misaligned and the airway open, physically stops the device from sliding too deep by abutting against the teeth – thereby controlling the insertion depth by forming a stop through the first stop, where the pharyngeal tissue is lifted by the action of the first and second stops, which keeps the upper airway open and reduces the risk of suffocation);
a second stop supported by the body (Figure 1 above; where the second stop ‘17’ is supported by the body of the device);
a thermoplastic element supported by the body, the thermoplastic element having a malleable state in which the thermoplastic element is configured to receive a dental impression from the patient and a set state for allowing fixation of the dental impression (Figure 1 above; where ‘40’ is a soft pad, Wei [0079-0080]; where the soft pad ‘40’ may be made of a TPU (thermoplastic) and the when the patient bites down on the body ‘10’ the upper and lower teeth act directly on the soft pad ‘40’ which can reduce the damage to the patient, where thermoplastic materials have a malleable state such that a dental impression from a patient could be formed a set state for fixation to happen);
wherein the thermoplastic element is arranged between the first stop and the second stop such that anterior and posterior movement of the thermoplastic element in relation to the body is restricted by means of the first stop and the second stop respectively (Figure 1 above; where the thermoplastic element ‘40’ is arranged between the first stop ‘15’ and the second stop ‘17’ because it annularly extends around between the first and second stops, where the anterior and posterior movement of the thermoplastic element in relation to the body is restricted because the movement is limited by the structural pieces the first and second stop respectively).
It would have been readily understood by one of ordinary skill in the art that a thermoplastic element would be able to have a malleable state to receive a dental impression from the patient and a set state for allowing fixation of the dental impression, since as evidenced by Suchan, [0022]; a thermoplastic element made of ethyl vinyl acetate (EVA), [0045]; dental impressions can be made from a thermoplastic, where it has a deformable state (malleable), and can be molded to have a fixed state, shaped in a manner of the teeth. Where the malleable state and fixed state are properties of a thermoplastic material.
Regarding claim 7, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1, wherein the second end of the body is curved (Figure 1 above; where the second end ‘14’ of the body is curved).
Regarding claim 12, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1, wherein the thermoplastic element is made of a material chosen from the group consisting of: Ateva* 4030AC, Ateva* 2820AG or Ateva*1807EG (Suchan [0022]; where the thermoplastic element is made of ethyl vinyl acetate (EVA) – which is the generic material name of the trademarks Ateva 4030AC, 2820AG, 1807EG).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei by having the thermoplastic material be EVA as taught by Suchan, since, EVA demonstrates sufficient strength and at the same time good light permeability (Suchan [0022]).
Regarding claim 15, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1, wherein the first stop and the second stop are integrally formed with the body (Wei [0116]; where the first stop ‘15’ and the second stop ‘17’ are integrally formed with the body ‘10’ of the mouthpiece).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2021082162 A1), as evidenced by Suchan (US 20060228675 A1), and further in view of Wallis (US 20210213225 A1).
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Figure 6: annotated Figures 21-24 of Wallis.
Regarding claim 2, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1, comprising a first and second stop (Figure 1 above; ‘15’ first stop, ‘17’ second stop);
and the thermoplastic element receiving the dental impression (Figure 1 above; where ‘40’ is a soft pad, Wei [0079-0080]; where the soft pad ‘40’ may be made of a TPU (thermoplastic) and the when the patient bites down on the body ‘10’ the upper and lower teeth act directly on the soft pad ‘40’ which can reduce the damage to the patient, where thermoplastic materials have a malleable state such that a dental impression from a patient could be formed a set state for fixation to happen).
Wei, as evidenced by Suchan is silent to a first protrusion.
Wallis discloses the bite block wherein:
the first stop comprises a first protrusion extending from the body and having an anterior sloping surface configured to induce anterior movement of the lower jaw of the patient (Figure 6 above; where there is a first stop configured to limit movement, with a first protrusion ‘40’ that extends from the body of the mouthpiece and has an anterior sloping surface that is configured to induce anterior movement of the lower jaw of the patient, Wallis [0099]; where ‘40’ acts as a tooth guide that engages with the teeth, preferentially biasing to inhibit the teeth from disengaging, it is fixed to the moving lower portion and transfers mechanical force, allowing for the longitudinal movement of the lower jaw).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei, as evidenced by Suchan to include a first protrusion portion extending from the body as taught by Wallis, since, the protrusion portion helps to inhibit damage to the teeth and the disengagement of the teeth while using the mouthpiece (Wallis [0099]).
Regarding claim 3, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1, comprising a first and second stop (Figure 1 above; ‘15’ first stop, ‘17’ second stop);
and the thermoplastic element receiving the dental impression (Figure 1 above; where ‘40’ is a soft pad, Wei [0079-0080]; where the soft pad ‘40’ may be made of a TPU (thermoplastic) and the when the patient bites down on the body ‘10’ the upper and lower teeth act directly on the soft pad ‘40’ which can reduce the damage to the patient, where thermoplastic materials have a malleable state such that a dental impression from a patient could be formed a set state for fixation to happen).
Wei, as evidenced by Suchan is silent to a second protrusion.
Wallis discloses the bite block wherein:
wherein the second stop comprises a second protrusion extending from the body and having an anterior sloping surface configurated for appropriately positioning the teeth of the upper and lower jaws in relation to the body (Figure 6 above; where ‘36’ acts as a second protrusion portion, extending from the body, for the upper jaw with an anterior sloping surface that is configured for positioning the lower and upper jaws in relation to the body of the mouthpiece, Wallis [0099]; where ‘36’ acts a tooth guide and manages the upper teeth to help position the teeth of the lower/upper jaw in relation to the device).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei, as evidenced by Suchan to include a second protrusion portion extending from the body as taught by Wallis, since, the protrusion portion helps to inhibit damage to the teeth and the disengagement of the teeth while using the mouthpiece (Wallis [0099]).
Regarding claim 4, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1.
Wei, as evidenced by Suchan fails to disclose a plurality of flanges extending from the body.
Wallis discloses the bite block wherein:
the second stop comprises a plurality of flanges extending from the body (Figure 6 above; where the second stop has a plurality of flanges (protrusions), ’36,40a,40b’ all extending from the body of the mouthpiece).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei, as evidenced by Suchan to include a plurality of flange portions extending from the body as taught by Wallis, since, the protrusion portion helps to inhibit damage to the teeth and the disengagement of the teeth while using the mouthpiece (Wallis [0099]).
Claims 5, 8, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2021082162 A1), as evidenced by Suchan (US 20060228675 A1), and further in view of Lee (KR 20170133032 A).
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Figure 2: annotated Figure 1 of Lee.
Regarding claim 5, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1.
Wei, as evidenced by Suchan is silent to the first stop comprising an annular flange.
Lee discloses a mouthpiece wherein:
the first stop comprises an annular flange associated with the first end of the body (Figure 2 above; where the first stop that is on the first end of the body of the mouthpiece is an annular flange).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei, as evidenced by Suchan to have an annular flange associated with the first end of the body as taught by Lee, since, this shape allows for close contact with the mouth of the patient (Lee [0042]).
Regarding claim 8, modified Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 5, wherein the annular flange is curved (Figure 2 above; where the annular flange is curved).
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Figure 3: annotated Figure 2 of Lee.
Regarding claim 9, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1.
Lee discloses the mouthpiece further comprising:
at least one tubular connection defining a side channel extending from an access port available from the first end of the body into the airway channel (Figure 3 above; where there is a tubular connection ‘113’ with a side channel inside that extends from an access port from the first end of the body, Lee [0044]; where the tubular connection can supply oxygen into the patient’s mouth, thereby having access to an airway channel to direct air to the patient).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei, as evidenced by Suchan to include a tubular connection as taught by Lee, since, the tubular connection allows for oxygen to be supplied to the patient’s mouth (Lee [0039]).
Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the position of the tubular connection to go through the airway channel since such a modification would simply involve merely the tubular connection to be connected with the airway channel, instead of outside of the airway channel formed on the inner body of the mouthpiece, without changing the operation of the device, a rearrangement of parts is generally recognized as being within the level of ordinary skill in the art (see MPEP 2144.04).
Regarding claim 14, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 1.
Wei as evidenced by Suchan fails to disclose that the airway channel has an elliptical cross-sectional area.
Lee discloses the mouthpiece wherein:
wherein the airway channel has an elliptical cross-sectional area (Lee Figure 3; where the body ‘120’, comprising the member ‘121’ has an elliptical cross-sectional area and the airway channel is formed by the shape of the body ‘120’, thereby the airway channel also has an elliptical cross-sectional area, Lee [0049, 0053], and Figure 2 above; where the airway channel has an elliptical shape).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei, as evidenced by Suchan to include an elliptically shaped cross-section of the airway channel as taught by Lee, since, this shape better corresponds to the shape of the opened lips of the patient (Lee [0053]).
Claims 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2021082162 A1), as evidenced by Suchan (US 20060228675 A1), further in view of Lee (KR 20170133032 A), and even further in view of Gulka (US 20160199609 A1).
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Figure 4: annotated Figure 10B of Gulka.
Regarding claim 6, modified Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 5.
Modified Wei, as evidenced by Suchan fails to disclose a grip element supported by the annular flange.
Gulka discloses a respiratory interface further comprising:
a grip element supported by the annular flange and configurated to facilitate manual handling of the mouthpiece (Gulka Figure 10B; ‘305’ is a grip element supported by the annular flange).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the modified mouthpiece of Wei, as evidenced by Suchan to include a grip element with the annular flange as taught by Gulka, since, a grip element helps medical professionals to insert or remove the mouthpiece (Gulka [0054]).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2021082162 A1), as evidenced by Suchan (US 20060228675 A1), and further in view of Flynn (US 7946288 B2).
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Figure 5: annotated Figures 3-4 of Flynn.
Regarding claim 10, Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 7.
Wei as evidenced by Suchan, fails to disclose that the thermoplastic element has a truncated conical shape tapering towards the second end of the body.
Flynn discloses the mouthpiece wherein:
the thermoplastic element has a truncated conical shape tapering towards the second end of the body (Flynn [015]; where the mouthpiece ‘10’ is made of a thermoplastic material (element), Figure 5 above; where the second end of the ring made of thermoplastic material ‘51’+’56’ has a truncated conical shape such that it tapers toward the second end of the body of the mouthpiece).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mouthpiece of Wei as evidenced by Suchan by having the thermoplastic element be a truncated conical shape as taught by Flynn, since, this shape creates a wide, unobstructed path for medical tools (Flynn [020]).
Regarding claim 11, modified Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 10, wherein the thermoplastic element has a posterior end having a curvature corresponding to that of the first end of the body (Figure 1 above; where there is a posterior end that has a curvature that corresponds to that of the first end ‘13’ of the body, because they both curve in the same way against the user for a better fit against the face).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wei (WO 2021082162 A1), as evidenced by Suchan (US 20060228675 A1), in view of Lee (KR 20170133032 A) and further in view of Anca (US 8684919 B2).
Regarding claim 13, modified Wei, as evidenced by Suchan further discloses the mouthpiece according to claim 9.
Modified Wei, as evidenced by Suchan fails to disclose a Luerlock fitting.
Anca discloses a mouthpiece wherein:
the access port of the at least one tubular connection comprises a fitting of a Luerlock* type (Anca [015]; where the tubular connection ‘142’ comprises a Luerlock fitting, Anca Figure 1A; where ‘142’ the tubular connection comprises the access port with the Luerlock fitting).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the modified mouthpiece of Wei, as evidenced by Suchan to include a Luerlock fitting with the tubular connection as taught by Anca, since, this type of fitting provides an air-tight seal and allows for oxygen to be provided to the patient (Anca [015]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Jacobs (US 5769633 A): oral application with a thermoplastic material consisting of EVA 10-40% weight vinyl acetate, portion being in range of 24%-26%.
Davis (US 8656925 B2): bite block with a similar shaped body portion.
Colman (US 20160325064 A1): tubular connection formed into the airway channel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AISLINN MOIRA JONES whose telephone number is (571)272-3835. The examiner can normally be reached Monday-Friday 7:30-5, EO Friday 7:30-4.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 5712707410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AISLINN M JONES/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
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