DETAILED ACTION
This Office action is in response to applicant’s amendments filed 05/18/2026. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The effective filing date of the present application is 01/08/2021. In applicant’s amendments filed 05/18/2026, claims 1, 10, 12, 16, and 18 were amended. Claims 1-20, as filed on 05/18/2026, are currently pending.
Applicant’s election with traverse of Species A (Figures 1A-3C, 5A, and 5B) and claims 1-20 in the reply filed on 05/18/2026 is acknowledged. The traversal is on the grounds that:
“[N]o search and/or examination burden exists” and [s]pecies A, B, C, D, E, F, G, H, I, J, K, and L are sufficiently related such that a thorough search for the subject matter of the claims 1-20 would encompass a search for the subject matter of all species.”
“Separation of the claims into separate species would not only cause duplicative examination along with unnecessary delay and expense, it would prevent the Applicant from pursuing full protection of the device as disclosed. The inability to protect the embodiment depicted in FIGS. 1A-24 in one set of claims would preclude the Applicant from full protection of its invention(s) at the United States Patent and Trademark Office.”
This is not found persuasive for the following reasons:
There is a serious search and/or examination burden for the patentably distinct species (Species A through L) as set forth above because the species require a different field of search that includes searching different classes/subclasses and employing different search strategies and search queries.
Separation of the claims into separate species would not cause duplicative examination, see immediately above. Figures 1-24 do not represent a single disclosed species or a single grouping of patentably indistinct species. Applicant is provided the ability to file one or more divisional applications in an effort to obtain “full protection of its invention(s) at the United States Patent and Trademark Office.”
The requirement is still deemed proper and is therefore made FINAL.
Claims 6, 7, and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-5 and 8-19, as filed on 05/18/2026, are considered below.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/19/2024 and 02/24/2026 were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 1, 12, and 16 are objected to because of the following informalities:
In claim 1, line 1, “the device comprising:” should be --- comprising: ---.
In claim 1, lines 2-3, “a device body comprising a mouthpiece sized and shaped to be insertable into a user's mouth” should be --- a device body comprising a mouthpiece configured to be sized and shaped to be insertable into a mouth of a user ---.
In claim 1, line 8, “the flow of fluid” should be --- a flow of fluid ---.
In claim 1, line 13, “such the user” should be --- such that the user ---.
In claim 1, lines 15-16, “the first amount” should be --- the first amount of negative pressure ---.
In claim 12, line 1, “the system comprising:” should be --- comprising: ---.
In claim 12, lines 11-13, “a restricted configuration in which a user must apply at least a first amount of negative pressure to create a first flow rate of the fluid” should be --- a restricted configuration configured such that a user must apply at least a first amount of negative pressure to create a first flow rate of a liquid through the lumen ---.
In claim 12, lines 14-17, “a less restricted configuration in which the user must apply at least a second amount of negative pressure to create a second flow rate of the fluid, wherein the second amount of negative pressure is greater than the first amount” should be --- a less restricted configuration configured such that the user must apply at least a second amount of negative pressure to create a second flow rate of the liquid through the lumen, wherein the second amount of negative pressure is greater than the first amount of negative pressure ---.
In claim 16, line 1, “the device comprising:” should be --- comprising: ---.
In claim 16, line 7, “to allow flow of liquid” should be --- to allow a flow of liquid ---.
In claim 16, line 9, “to allow liquid to flow” should be --- to allow the liquid to flow ---.
In claim 16, lines 11-12, “wherein the at least one distal opening is urged into the second, open configuration when a user” should be --- wherein the at least one distal opening is configured to be urged into the second, open configuration when a user ---.
Appropriate correction is required.
Terminal Disclaimer
The terminal disclaimer filed on 03/06/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent Numbers 11,724,154 and 12,138,508 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Double Patenting
The closest prior art of record is applicant’s U.S. Patent Numbers 11,724,154 and 12,138,508. In the interest of compact prosecution, any nonstatutory double patenting rejections that would have been applied in the instant application have been preemptively obviated by applicant’s terminal disclaimer filed on 03/06/2026, see above.
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.
Claims 1-4, 8, and 12-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davies (US 2010/0181329).
Regarding claim 1, Davies discloses an oropharyngeal exercise device (Figures 6, 7, 9, 11, and 12), the device comprising:
(a) a device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12) comprising a mouthpiece (the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 6, 7, 9, 11, and 12) sized and shaped to be insertable into a user's mouth;
(b) a lumen (the liquid passage 36; Figures 6 and 12) defined within the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12);
(c) a flow restriction structure (the slit 42; Figures 9 and 11) associated with the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12), wherein the flow restriction structure comprises:
(i) a restricted configuration in which the flow restriction structure is configured to restrict the flow of fluid through the lumen such that the user must apply at least a first amount of negative pressure to create a first flow rate of the fluid; and
(ii) a less restricted configuration in which the flow restriction structure is configured to restrict the flow of fluid through the lumen such the user must apply at least a second amount of negative pressure to create a second flow rate of the fluid, wherein the second amount of negative pressure is greater than the first amount, and wherein the second flow rate is greater than the first flow rate
(According to paragraph 0040, “Mouthpiece portion 76 may take a variety of configurations including (but not limited to) mouthpiece portions that include a user-actuated valve adapted to permit selective dispensing of drink liquid from the drink container, mouthpiece portions that permit a user to draw, or suck, drink liquid from the drink container, mouthpiece portions that permit a user to squeeze drink liquid from the drink container, and/or other configurations of mouthpiece portions. Illustrative, non-exclusive examples of mouthpiece portions, including bite-actuated mouthpieces, that may be utilized with or incorporated into mouthpiece assemblies according to the present disclosure.” Emphasis added. According to paragraph 0041, “When the mouthpiece portion includes a bite-actuated valve, which refers to a valve that is urged from a closed configuration to an open configuration by a user biting upon the valve (such as opposed sidewalls thereof) the mouthpiece portion may be referred to as a bite-actuated mouthpiece. Bite-actuated valves (and/or bite-actuated mouthpieces) are typically biased to a closed configuration, and thus automatically return from an open configuration to a closed configuration upon release of the compressive forces being applied thereto by a user, such as by a user's teeth and/or mouth.” Emphasis added. Davies discloses that the bite-actuated valve (the slit 42; Figures 9 and 11) is adjustable when urged from the closed configuration to the open configuration by a selective amount of the compressive forces being applied to the mouthpiece portion by the user biting upon the bite-actuated valve (the slit 42; Figures 9 and 11). The Office considers the limitations (i) and (ii), see above, to be functional language. Davies therefore discloses all of the structural limitations of the claim and is capable of performing the functions of the restricted configuration (i) and the less restricted configuration (ii).); and
(d) at least one distal opening (the slit 42; Figures 9 and 11) defined in the mouthpiece (the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 6, 7, 9, 11, and 12) and in fluidic communication (Figures 6, 7, 9, 11, and 12) with the lumen (the liquid passage 36; Figures 6 and 12), wherein the flow restriction structure (the slit 42; Figures 9 and 11) can be the at least one distal opening.
Regarding claim 2, Davies further discloses wherein the mouthpiece has an ovular cross-sectional shape (refer to the annotated Figure 11, see below).
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Regarding claim 3, Davies further discloses wherein the at least one distal opening is a slit defined in a distal end of the mouthpiece (the slit 42 is defined in the distal end of the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 9 and 11).
Regarding claim 4, Davies further discloses wherein a length of the slit is parallel with a cross-sectional width of the mouthpiece (refer to the annotated Figure 11, see below).
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Regarding claim 8, Davies further discloses wherein the device body further comprises a proximal opening (the crimping region 44; Figures 6 and 12) in fluidic communication with the lumen (the crimping region 44 is in fluidic communication with the liquid passage 36; Figure 12), wherein the proximal opening is sized to couple with an elongate tube (the straw 68; Figure 12).
Regarding claim 12, Davies discloses an oropharyngeal exercise system, the system comprising:
(a) a liquid container (the liquid container 12; Figure 7);
(b) a lid (the cap assembly 14/114; Figure 7) removably coupleable to the liquid container (Figures 11 and 12); and
(c) an exercise device (the rigid collar member 70/170 together with the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12) removably coupleable with the lid (Figure 11), the exercise device comprising:
(i) a device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12) comprising a mouthpiece (the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 6, 7, 9, 11, and 12);
(ii) a lumen (the liquid passage 36; Figures 6 and 12) defined within the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12); and
(iii) at least one distal opening (the slit 42; Figures 9 and 11) defined in the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12) and in fluidic communication (Figures 6, 7, 9, 11, and 12) with the lumen (the liquid passage 36; Figures 6 and 12), wherein the at least one distal opening comprises:
(A) a restricted configuration in which a user must apply at least a first amount of negative pressure to create a first flow rate of the fluid; and
(B) a less restricted configuration in which the user must apply at least a second amount of negative pressure to create a second flow rate of the fluid, wherein the second amount of negative pressure is greater than the first amount, and wherein the second flow rate is greater than the first flow rate and increases exponentially as the second amount of negative pressure continues to be applied
(According to paragraph 0040, “Mouthpiece portion 76 may take a variety of configurations including (but not limited to) mouthpiece portions that include a user-actuated valve adapted to permit selective dispensing of drink liquid from the drink container, mouthpiece portions that permit a user to draw, or suck, drink liquid from the drink container, mouthpiece portions that permit a user to squeeze drink liquid from the drink container, and/or other configurations of mouthpiece portions. Illustrative, non-exclusive examples of mouthpiece portions, including bite-actuated mouthpieces, that may be utilized with or incorporated into mouthpiece assemblies according to the present disclosure.” Emphasis added. According to paragraph 0041, “When the mouthpiece portion includes a bite-actuated valve, which refers to a valve that is urged from a closed configuration to an open configuration by a user biting upon the valve (such as opposed sidewalls thereof) the mouthpiece portion may be referred to as a bite-actuated mouthpiece. Bite-actuated valves (and/or bite-actuated mouthpieces) are typically biased to a closed configuration, and thus automatically return from an open configuration to a closed configuration upon release of the compressive forces being applied thereto by a user, such as by a user's teeth and/or mouth.” Emphasis added. Davies discloses that the bite-actuated valve (the slit 42; Figures 9 and 11) is adjustable when urged from the closed configuration to the open configuration by a selective amount of the compressive forces being applied to the mouthpiece portion by the user biting upon the bite-actuated valve (the slit 42; Figures 9 and 11). The Office considers the limitations (A) and (B), see above, to be functional language. Davies therefore discloses all of the structural limitations of the claim and is capable of performing the functions of the restricted configuration (A) and the less restricted configuration (B).).
Regarding claim 13, Davies further discloses wherein the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12) comprises an attachment structure (the anchor portion 86; Figure 11), wherein the attachment structure is configured to sealably couple (Figure 12) with an opening (the through-passage 34; Figure 11) defined in the lid (the cap assembly 14/114; Figures 7 and 11).
Regarding claim 14, Davies further discloses an elongate tube (the straw 68; Figures 7 and 12) removably coupleable (Figure 11) with the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12).
Regarding claim 15, Davies further discloses wherein the at least one distal opening is a slit defined in a distal end of the mouthpiece (the slit 42 is defined in the distal end of the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 9 and 11).
Regarding claim 16, Davies discloses an oropharyngeal exercise device (Figures 6, 7, 9, 11, and 12), the device comprising:
(a) a device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12) comprising a distal extension (the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 6, 7, 9, 11, and 12) comprising a pliable material (the bite-actuated mouthpiece 176 is made of a pliable material; paragraphs 0040-0041);
(b) a lumen (the liquid passage 36; Figures 6 and 12) defined within the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12); and
(c) at least one distal opening (the slit 42; Figures 9 and 11) defined in the distal extension (the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 6, 7, 9, 11, and 12) and in fluidic communication (Figures 6, 7, 9, 11, and 12) with the lumen (the liquid passage 36; Figures 6 and 12), wherein the at least one distal opening comprises:
(i) a first, restricted configuration configured to allow flow of liquid therethrough at a first flow rate; and
(ii) a second, open configuration configured to allow liquid to flow therethrough at a second flow rate greater than the first flow rate,
wherein the at least one distal opening is urged into the second, open configuration when a user has applied a predetermined amount of compressive force to external walls of the distal extension via a tongue of the user, wherein the pliable material facilitates formation of the second, open configuration
(According to paragraph 0040, “Mouthpiece portion 76 may take a variety of configurations including (but not limited to) mouthpiece portions that include a user-actuated valve adapted to permit selective dispensing of drink liquid from the drink container, mouthpiece portions that permit a user to draw, or suck, drink liquid from the drink container, mouthpiece portions that permit a user to squeeze drink liquid from the drink container, and/or other configurations of mouthpiece portions. Illustrative, non-exclusive examples of mouthpiece portions, including bite-actuated mouthpieces, that may be utilized with or incorporated into mouthpiece assemblies according to the present disclosure.” Emphasis added. According to paragraph 0041, “When the mouthpiece portion includes a bite-actuated valve, which refers to a valve that is urged from a closed configuration to an open configuration by a user biting upon the valve (such as opposed sidewalls thereof) the mouthpiece portion may be referred to as a bite-actuated mouthpiece. Bite-actuated valves (and/or bite-actuated mouthpieces) are typically biased to a closed configuration, and thus automatically return from an open configuration to a closed configuration upon release of the compressive forces being applied thereto by a user, such as by a user's teeth and/or mouth.” Emphasis added. Davies discloses that the bite-actuated valve (the slit 42; Figures 9 and 11) is adjustable when urged from the closed configuration to the open configuration by a selective amount of the compressive forces being applied to the mouthpiece portion by the muscles of the mouth (the tongue is one of the muscles of the mouth) and/or the teeth of the user upon the bite-actuated valve (the slit 42; Figures 9 and 11). The Office considers the limitations (i) and (ii), see above, to be functional language. Davies therefore discloses all of the structural limitations of the claim and is capable of performing the functions of the first, restricted configuration (i) and the second, open configuration (ii).).
Regarding claim 17, Davies further discloses a proximal opening (the crimping region 44; Figures 6 and 12) defined in the device body (the mouthpiece assembly 18/118; Figures 6, 7, 9, 11, and 12), wherein the proximal opening is in fluidic communication with the lumen (the crimping region 44 is in fluidic communication with the liquid passage 36; Figure 12).
Regarding claim 18, Davies further discloses wherein the distal extension is a mouthpiece (the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 6, 7, 9, 11, and 12) configured for insertion into a mouth of the user.
Regarding claim 19, Davies further discloses wherein the at least one distal opening is defined in a distal end of the distal extension (the slit 42 is defined in the distal end of the mouthpiece portion 76 in the form of the bite-actuated mouthpiece 176; Figures 9 and 11).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 2010/0181329) in view of Choi (US 2006/0226110).
Regarding claim 5, Davies discloses the invention as substantially claimed, see above, but is silent as to: wherein the slit comprises stress relief openings defined at each end of the slit.
Choi teaches an analogous oropharyngeal exercise device (paragraph 0002: “The present disclosure relates generally to drink bottles, and more particularly to drink bottles with bite-actuated mouthpieces.”) wherein a slit comprises stress relief openings defined at each end of the slit (refer to the annotated Figure 16, see below).
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It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the mouthpiece and the slit of Davies’s invention such that the slit comprises stress relief openings defined at each end of the slit, as taught by Choi, in order to obtain the predictable result of increasing the durability and longevity of the mouthpiece over the functional life of the device.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Davies (US 2010/0181329) in view of Suzuki (CN 102020051 A).
Regarding claim 9, Davies discloses the invention as substantially claimed, see above, but is silent as to: wherein the mouthpiece comprises a length of 7 mm to 65 mm.
Suzuki teaches an analogous oropharyngeal exercise device (the beverage container 1; Figures 1A and 1B) wherein a mouthpiece (the mouthpiece 12, 22 of the suction adapter 10, 20; Figures 1A and 1B) comprises a length of 7 mm to 65 mm (h1, h2 of the mouthpiece 12, 22 is 17 mm; paragraph 0041; Figures 1A and 1B).
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the mouthpiece of Davies’s invention such that it comprises a length of 7 mm to 65 mm, as taught by Suzuki, and particularly because ensuring that the length of a mouthpiece of a beverage container is suitable for use in a mouth of a user involves only routine skill in the art.
Regarding claim 10, Davies discloses the invention as substantially claimed, see above, but is silent as to: wherein the mouthpiece comprises a material with a hardness ranging from 25A durometer to 45A durometer.
Suzuki teaches an analogous oropharyngeal exercise device (the beverage container 1; Figures 1A and 1B) wherein a mouthpiece (the mouthpiece 12, 22 of the suction adapter 10, 20; Figures 1A and 1B) comprises a material with a hardness ranging from 25A durometer to 45A durometer (paragraph 0042: “The suction adapter 10, 20 can be made of various elastic materials, but as one example, silicon can be used as raw material. In the this case, the hardness of the silicon according to Japanese industrial standard (JIS) of K6253 durometer rebound hardness type A and preferably is about 40.”).
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the mouthpiece of Davies’s invention such that it comprises a material with a hardness ranging from 25A durometer to 45A durometer, as taught by Suzuki, and particularly because ensuring that the hardness of an elastic material of a mouthpiece of a beverage container is suitable for use in a mouth of a user involves only routine skill in the art.
Regarding claim 11, Davies discloses the invention as substantially claimed, see above, but is silent as to: wherein the mouthpiece comprises a wall having a thickness ranging from 0.1 mm to 10 mm.
Suzuki teaches an analogous oropharyngeal exercise device (the beverage container 1; Figures 1A-2B) wherein a mouthpiece (the mouthpiece 12, 22 of the suction adapter 10, 20; Figures 1A-2B) comprises a wall having a thickness ranging from 0.1 mm to 10 mm (The wall thickness of the mouthpiece 12 equals one-half of d1 (d1 = 9 mm; paragraph 0041; Figures 1A and 2A) minus D1 (D1 = 4 mm; paragraph 0041; Figure 1A), which is 2.5 mm. The wall thickness of the mouthpiece 22 equals one-half of d2 (d2 = 8.2 mm; paragraph 0041; Figures 1B and 2B) minus D2 (D2 = 4 mm; paragraph 0041; Figure 1B), which is 2.1 mm.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the mouthpiece of Davies’s invention such that it comprises a wall having a thickness ranging from 0.1 mm to 10 mm, as taught by Suzuki, and particularly because ensuring that the wall thickness of a mouthpiece of a beverage container is suitable for use in a mouth of a user involves only routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY D URBIEL GOLDNER whose telephone number is (313)446-6554. The examiner can normally be reached between 9AM and 5PM, Eastern Time, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LoAn B Jimenez can be reached on (571)272-4966. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/GARY D URBIEL GOLDNER/Primary Examiner, Art Unit 3784
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