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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/05/2025 was filed after the mailing date of the application on 11/18/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of claims 16-26 in the reply filed on 04/27/2026 is acknowledged.
Newly added claims 36-37 are directed to the flexible mouthpiece for distribution of a liquid in a user's mouth of claim 16; and are therefore, properly considered part of the elected invention.
Claims 27-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/27/2026.
Claim Objections
Claims 27-35 are withdrawn from further consideration and should be labeled “Withdrawn”.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 16, 20-23, 26 and 36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9 and 26 of U.S. Patent No. 12245908. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
It is clear that all the elements of claims 16, 20-23, 26 and 36 in the immediate application are found in claims 1, 9 and 26 of the U.S. Patent. The claims are not identical; however, the mouthpiece, cited in the immediate application, comprising an inlet for a tube; at least two outlets; and a single internal channel that fluidically connects the at least two outlets to each other and to the inlet … ; would have been obvious over the mouthpiece cited in the original US. Patent. The difference between the claims of the immediate application and the claims of the US. Patent lies in the fact that the US. Patent’s claims include many more elements and is thus much more specific. Thus, the invention of the US. Patent is in effect a “species” of the “generic” invention of the immediate application. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since the claims in the immediate application are anticipated by the claims of the US. Patent, therefore, the immediate application is not patentably distinct from the claims of the US. Patent. Claims 16, 20-23, 26 and 36 in the immediate application have been analyzed and rejected with respect to claims 1, 9 and 26 of U.S. Patent No. 12245908.
The instant application reads on the U.S. Patent based on the underline portion. Please see the double patenting analysis in the table below.
Instant Application (18951523)
U.S. Patent No. 12245908.
Claims 16, 22-23, 26 and 36 are rejected with respect to claim 1 of the U.S. Patent.
Claim 16
A flexible mouthpiece for distribution of a liquid in a user's mouth, the mouthpiece comprising: an inlet for a tube; at least two outlets; and a single internal channel that fluidically connects the at least two outlets to each other and to the inlet, wherein the mouthpiece is configured to be positioned within a superior vestibule of the user's mouth apical to a gingival margin, wherein the mouthpiece is formed of 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.
Claim 22
wherein a width of the mouthpiece is in the range of 0.6cm to 1.0cm.
Claim 23
wherein a width of the internal channel is in the range of 1mm to 3mm.
Claim 26
wherein each sheet of the two sheets of flexible material has a thickness of less than 0.5mm.
Claim 36
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.
Claim 1
A mouthpiece for distribution of a liquid in a user's mouth, the mouthpiece comprising: an inlet for a tube; at least two outlets; and a single internal channel that fluidically connects the at least two outlets to each other and to the inlet, wherein the mouthpiece is configured to be positioned within a superior vestibule of the user's mouth apical to a gingival margin, wherein the mouthpiece is formed of two sheets that are bonded together, apart from in an unfixed region that defines the internal channel, such that a thickness of the mouthpiece is less than 1.0 mm, wherein a width of the mouthpiece is between 0.6 cm and 1.0, and wherein a width of the internal channel is in a range of 1mm to 3mm.
Claim 20 is rejected with respect to claim 26 of the U.S. Patent.
Claim 20
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.
Claim 26
A mouthpiece for distribution of a liquid in a user's mouth, the mouthpiece comprising: an inlet for a tube; at least two outlets; and a single internal channel that fluidically connects the at least two outlets to each other and to the inlet, wherein the mouthpiece is configured to be positioned within a superior vestibule of the user's mouth apical to a gingival margin, wherein the mouthpiece is formed of two sheets that are bonded together, apart from in an unfixed region that defines the internal channel, such that a thickness of the mouthpiece is less than 1.0 mm, wherein a width of the mouthpiece is between 0.6 cm and 1.0 cm, and wherein a cross-sectional width of the internal channel is between 2 and 16 times greater than a cross-sectional thickness of the internal channel.
Claim 21 is rejected with respect to claim 9 of the U.S. Patent.
Claim 21
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.
Claim 9
further comprising a slit configured to receive a labial frenulum of the user, and two flaps adapted to fit within the cavities of the superior vestibule which are present on each side of the labial frenulum.
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 is formed of 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]).
Wherein the mouthpiece is formed of 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.
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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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS MIGUEL RUIZ MARTIN whose telephone number is (571)270-0839. The examiner can normally be reached M-F 8 Am - 5 PM (EST).
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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/
Examiner, Art Unit 3772
/ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
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