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 .
Response to Arguments
Applicant’s arguments, see Remarks filed on 08/20/2026, have been fully considered. The Double Patenting rejection previously presented is withdrawn in light of the Terminal Disclaimer filed on 08/20/2026. Applicant’s arguments against the rejections in view of the prior art of record have been fully considered, but are not persuasive.
The Examiner respectfully disagrees with Applicant’s assessments. Cash discloses a mouthpiece that has all the necessary structures to be positioned in a variety of place inside the oral cavity. For instance, the mouthpiece is configured to be positioned within a superior vestibule of the user's mouth apical to a gingival margin (since Cash discloses that the mouthpiece is inserted into the patient's mouth between the patient's teeth, top or bottom, and cheek/lip [0066] and that the mouthpieces sit between the teeth, upper and/or lower, and the cheek and/or lips, such as is illustrated in FIGS. 7-11 [0052]). Additionally, Cash’s mouthpiece has all the structures necessary to be configured to be positioned within a superior vestibule of the user's mouth apical to a gingival margin.
The following limitations are still deemed product-by-process limitations: “Wherein the mouthpiece comprises two sheets of a flexible material that are bonded together, wherein the two sheets of flexible material are unbonded in an unfixed region that defines the internal channel” are being treated as a product-by-process limitations and a product-by-process claim is not limited to the manipulations of the recited steps (e.g. bonding two sheets together), only the structure implied by the steps (e.g. a mouthpiece with a channel formed therein). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., internal channel being equidistant between the inner portions towards the teeth and the outer portions of the mouthpiece, fallowing a regular path; see page 11 of the Remarks) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Regarding claim 26, the Applicant argues that the applied prior art (Cash US 20150328084 A1 and De Vreese US 20120322024 A1) in combination, contradict each other teachings. The Examiner notes that De Vreese is relied upon only for the teachings of the specific thickness of the flexible material, which is a structure in an analogous device. Said device is analogous because is a device worn in the mouth which delivers liquid.
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) 16-20 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cash (US 20150328084 A1).
Regarding claim 16, the claimed limitations “Wherein the mouthpiece comprises two sheets of a flexible material that are bonded together, wherein the two sheets of flexible material are unbonded in an unfixed region that defines the internal channel” are being treated as a product-by-process limitations and a product-by-process claim is not limited to the manipulations of the recited steps (e.g. bonding two sheets together), only the structure implied by the steps (e.g. a mouthpiece with a channel formed therein). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. MPEP 2113.
Cash embodiment according to Figure 7 teaches a flexible mouthpiece (80) for distribution of a liquid in a user's mouth ([0065]), the mouthpiece comprising: an inlet (84) for a tube (Annotated Figure 7); at least two outlets (88); and a single internal channel (83) that fluidically connects the at least two outlets to each other and to the inlet (Figure 7, since Cash discloses the single internal channel 86). The Examiner notes that channel 86 is a single channel structure since there is no division/partition between either of its two sides and both sides share a common junction with the tube that allows liquid to pass from the inlet to the channel. Please see Annotated Figure 7.
Wherein the mouthpiece is configured to be positioned within a superior vestibule of the user's mouth apical to a gingival margin (since Cash discloses that the mouthpiece is inserted into the patient's mouth between the patient's teeth, top or bottom, and cheek/lip [0066] and that the mouthpieces sit between the teeth, upper and/or lower, and the cheek and/or lips, such as is illustrated in FIGS. 7-11 [0052]). Additionally, Cash’s mouthpiece has all the structures necessary to be configured to be positioned within a superior vestibule of the user's mouth apical to a gingival margin.
Wherein the mouthpiece comprises two sheets of a flexible material that are bonded together, wherein the two sheets of flexible material are unbonded in an unfixed region that defines the internal channel (since the fluid channel 86 is defined in the body of the mouthpiece; see Figure 7, [0065]). The Examiner notes that process by which the mouthpiece is formed does not determine patentability, instead patentability is based on the product itself. The mouthpiece disclosed by Cash is structurally identical to the claimed mouthpiece. The final product is the same as is claimed.
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Regarding claim 17, Cash discloses wherein the flexible material comprises a silicone material ([0058]).
Regarding claim 18, Cash discloses wherein the mouthpiece is constructed such that, when in use, each outlet of the at least two outlets is positioned complementary to an opening of a parotid duct in the user's mouth (since the mouthpiece can seat in the maxilla/upper teeth [0052] and the outlets 88 are located around the location of the third molars or the wisdom teeth Figures 7-8; therefore the at least two outlets is positioned complementary to an opening of a parotid duct).
Regarding claim 19, Cash discloses wherein the mouthpiece is configured to follow the contour of a mucous membrane of the user's mouth (since the fluid outlet(s) may face the cheek, one or more specific locations on the attached gingiva or the mucosa [0055] and the outlets of the channels are advantageously directed towards the cheek to allow for the deposited fluid/suspension to exit and “trickle” down the buccal mucosa [0067]).
Regarding claim 20, Cash discloses wherein the mouthpiece is configured such that when the mouthpiece is positioned apical to the gingival margin it is not in contact with teeth of the user (since the locations of the fluid outlet(s) may be selected by the practitioner to suit different needs, such as dry mouth, wound healing, infection control, periodontal therapy, etc.; e.g. attached to the gingiva [0055]). Additionally, the Examiner notes that Cash’s mouthpiece has all the necessary structures to be configured to such that when the mouthpiece is positioned apical to the gingival margin it is not in contact with teeth of the user (note that as shown in Figure 8, a user would just need to lower the mouthpiece, e.g. a few millimeters, to avoid contact with the teeth).
Regarding claim 36, Cash discloses wherein one of the two sheets of flexible material has at least two holes and the unfixed region that defines the internal channel is between the two holes (i.e. Cash’s holes 88 and the unfixed region that defines the internal channel, i.e. Cash’s channel 83 is between the two holes 88).
Claims 21 is rejected under 35 U.S.C. 103 as being unpatentable over Cash in view of Martin (US 20110270166 A1).
Regarding claim 21, Cash fails to disclose “further comprising two flaps configured to fit within superior vestibule cavities that are present on each side of a labial frenulum in the user's mouth”.
Martin discloses a mouthpiece, for delivering a fluid to the mouth or oropharynx of a user (Abstract). Martin discloses that the mouthpiece comprises a slit (516) wherein a labial frenulum may fit, preferably comprising two flaps (Annotated Figure 31) adapted to fit within the cavities of the superior vestibule which are present on each side of a labial frenulum ([0081]). Therefore, it would have been obvious to one of ordinary skills in the art before the effective filing date of the claimed invention to modify Cash’s mouthpiece to add the structure of a slit wherein a labial frenulum may fit, as taught by Martin; since such modification would make the device comfortable for a long period of time when worn in the maxillary gingiva.
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Claims 22 and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Cash in view of Finlay (AU 2015200296 B2).
Regarding claim 22, Cash fails to disclose “wherein a width of the mouthpiece is in the range of 0.6cm to 1.0cm”.
Finlay discloses a mouthpiece for distribution of a liquid in a user's mouth; (Abstract and [0048]). The mouthpiece (Figure 14-16, member 100) comprising an inlet for a tube (Finlay’s Annotated Figure 14) and an internal channel (122) with at least two outlets (124) (Figure 16 and Finlay’s Annotated Figure 14; [0067]). Wherein the mouthpiece is configured to be positioned within a superior 102 vestibule of the user's mouth apical to a gingival margin (Figure 16; [0067]). Finlay discloses wherein the mouthpiece is wider than it is thick; since the mouthpiece is e.g. 5 mm high/wide, and 1 mm thick ([0067]). However, Finlay does not explicitly teach that the width of the mouthpiece is between 0.6 cm and 1.0 cm.
It would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify Cash’s device in order to make it 5 mm (0.5cm) wide, as taught by Finlay; since such modification would improve the device dimensions for optimal placement and fit ([0067]).
Cash and Finlay, as modified above, teaches a range close to the claimed limitation with respect to the width; for example being only 1 mm shorter. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the width of Cash/Finlay’s mouthpiece to have a width of at least 0.6 cm, since a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close enough such that one of skill in the art would have expected them to have the same properties. See MPEP 2144.05(I)).
Regarding claim 24, Cash discloses that the mouthpiece is made of silicon ([0058]), which could be a flexible, stretchable material; but fails to specifically discloses “wherein the flexible material of the mouthpiece is configured to stretch such that the dimensions of the internal channel increase when filled with fluid”.
Finlay discloses a mouthpiece (100) for distribution of a substance in a user's mouth; (Abstract and [0115]). The mouthpiece (Figure 32) comprising a flexible material configured to stretch such that the dimensions of the internal channel (compliant tubing 141) increase when filled with fluid (since for example, pressurized gas, delivered through the oral appliance and originating at its input end, will act on the compliant tubing with resulting expansion and contraction of the tubing in direct relation to changes in pressure of the substance within the tubing [0115]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Cash’s device in order to make it comprising the flexible material configured to stretch such that the dimensions of the internal channel increase when filled with fluid, since such modification would create a kinetic stimulus acting directly upon the surrounding oral tissues, exciting sensory receptors located in the oral mucosal lining ([0115]).
Regarding claim 25, Cash fails to disclose “wherein a width of the mouthpiece is between 2 and 6 times a thickness of the mouthpiece”.
Finlay discloses a mouthpiece that is wider than it is thick; since the mouthpiece is e.g. 5 mm high/wide, and 1 mm thick ([0067]). Therefore, Finlay discloses wherein a width of the mouthpiece is between 2 and 6 times a thickness of the mouthpiece. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify Cash’s device in order to make it 5 mm (0.5cm) wide and 1 mm thick, as taught by Finlay; since such modification would improve the device dimensions for optimal placement and fit ([0067]).
Claims 23 is rejected under 35 U.S.C. 103 as being unpatentable over Cash in view of Goldstein (US 20180368598 A1).
Regarding claim 23, Cash fails to disclose “wherein a width of the internal channel is in the range of 1mm to 3mm”.
Goldstein discloses mouthpiece (100) for distribution of a liquid in a user's mouth ([0022]), the mouthpiece comprising: a single internal channel (110), wherein a width of the internal channel is in the range of 1mm to 3mm (since it could be 0.1 cm [0032]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Cash’s device in order to make the width of the internal channel 1 mm, since such modification would improve the device dimensions for optimal comfort.
Claims 26 is rejected under 35 U.S.C. 103 as being unpatentable over Cash in view of De Vreese (US 20120322024 A1).
Regarding claim 26, Cash fails to disclose “wherein each sheet of the two sheets of flexible material has a thickness of less than 0.5mm”.
De Vreese discloses a device for delivering an oral composition to the teeth or gingival tissues comprising a sheet of an orally acceptable flexible material (Abstract). Wherein the sheet of a flexible material has a thickness of less than 0.5mm ([0078]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Cash’s sheets of flexible material to make them each having a thickness of less than 0.5mm, since such modification would create a minimally invasive dental appliance that posterize comfort.
Claims 37 is rejected under 35 U.S.C. 103 as being unpatentable over Cash in view of Haider (EP 3488979 A1, see the translation attached to this Office Action).
Regarding claim 37, Cash fails to disclose “further comprising a vulcanized
platinum crosslinking agent serving to bond the two sheets of flexible material together”.
Haider discloses that two-component systems based on crosslinking silicone polymers are suitable in the field of dental technology, two-component silicone rubbers with platinum catalyzed crosslinkers are used as impression materials, since they cure at room temperature and form no fission products (see page 2, last paragraph to page 3 first paragraph). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Cash’s mouthpiece to add vulcanized platinum crosslinking agent serving to bond the two sheets of flexible material together, since such modification provides a method for curing silicone rubber without shrinkage and without release of odor or taste-impairing substances, which is very important for medical applications (see page 2, last paragraph to page 3 first paragraph).
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 extension fee 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 LUIS RUIZ whose telephone number is (571)270-0839. The examiner can normally be reached on M-F 8 Am - 5 PM (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Luis Ruiz Martin/
Patent Examiner
Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
