Prosecution Insights
Last updated: May 29, 2026
Application No. 18/428,749

WAX-BASED COMPOSITIONS, ARTICLES MADE THEREFROM, AND METHODS OF MANUFACTURE AND USE

Final Rejection §103§112
Filed
Jan 31, 2024
Priority
Mar 08, 2013 — provisional 61/775,453 +5 more
Examiner
MORAN, EDWARD JOHN
Art Unit
3772
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Ultradent Products Inc.
OA Round
2 (Final)
41%
Grant Probability
Moderate
3-4
OA Rounds
1y 2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 41% of resolved cases
41%
Career Allowance Rate
264 granted / 637 resolved
-28.6% vs TC avg
Strong +61% interview lift
Without
With
+60.6%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
33 currently pending
Career history
689
Total Applications
across all art units

Statute-Specific Performance

§101
0.6%
-39.4% vs TC avg
§103
82.5%
+42.5% vs TC avg
§102
5.7%
-34.3% vs TC avg
§112
8.7%
-31.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 637 resolved cases

Office Action

§103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. Response to Amendment This action is in response to Applicant’s amendment filed 2/25/26. The amendment to the specification filed 2/25/26 has been entered. Note: Although Applicant’s arguments state that a terminal disclaimer to US 11931220 has been filed, it does not appear in the file. Response to Arguments Applicant's arguments filed 2/25/26 have been fully considered but they are not persuasive and additionally do not address the new grounds of rejection and/or interpretation below necessitated by Applicant’s amendments. Briefly, Applicant argues that the prior art combination does not teach the newly added limitations of the claims. However, the Examiner respectfully disagrees based on the new interpretation and explanation below, necessitated by the amendments. 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 1-3, 8-10, 12-16 and 18-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 12, 16 and 21 of U.S. Patent No. 11,931,220. Although the claims at issue are not identical, they are not patentably distinct from each other because US 11,931,220 anticipates all claim limitations. Regarding claim 1, US 11931220 discloses a dental tray, comprising: a composition comprising greater than 40% and up to 95% by weight of a wax component and a thermoplastic elastomer component blended with the wax component, wherein the composition is substantially free of ethylene-vinyl acetate copolymer (EVA), wherein the composition comprises at least 50% by combined weight of the wax and the thermoplastic elastomer (e.g. in instances where the wax is at least 50% weight, encompassed by ‘220, the combined weight of the wax and TPE would be greater 50%), wherein the composition is formed into a barrier layer forming at least an interior surface of the dental tray, wherein the dental tray is deformable by application of an external force and maintains its shape without significant deformation in the absence of an external force at a temperature of 25 C(e.g. plastically deformable; see claim 1). Regarding claim 2, US 11931220 discloses wherein the wax component is selected from the group consisting of petroleum wax, distilled wax, synthetic wax, mineral wax, vegetable wax, and animal wax (see claim 1). Regarding claim 3, US 11931220 discloses wherein the petroleum wax comprises at least one of paraffin wax, microcrystalline wax, or intermediate wax (see claims 2-3). Regarding claims 8-10, US 11931220 discloses wherein the thermoplastic elastomer component comprises at least one olefin-based elastomer, wherein the at least one olefin-based elastomer is selected from the group consisting of ethylene-, propylene-, and butylene-based elastomers, and wherein the dental tray is plastically deformable at room temperature and thermally stable at a temperature up to at least 40°C (see claim 1). Regarding claim 12, US 11931220 discloses a dental treatment composition adjacent to or impregnated within the barrier layer (see claim 7). Regarding claim 13, US 11931220 discloses a dental treatment device, comprising: a strip formed from a composition comprising greater than 40% and up to 95% by weight of a wax component and a thermoplastic elastomer component blended with the wax component, wherein the composition is substantially free of ethylene-vinyl acetate copolymer (EVA); wherein the composition comprises at least 50% by combined weight of the wax and the thermoplastic elastomer (e.g. in instances where the wax is at least 50% weight, encompassed by ‘220, the combined weight of the wax and TPE would be greater 50%); and a dental treatment composition adjacent to or impregnated within the strip, wherein the strip is deformable by application of an external force and maintains its shape without significant deformation in the absence of another external force at a temperature of 25 C (e.g. plastically deformable; see claim 12). Regarding claim 14, US 11931220 discloses wherein the wax component is selected from the group consisting of petroleum wax, distilled wax, synthetic wax, mineral wax, vegetable wax, and animal wax (see claim 12). Regarding claim 15, US 11931220 discloses wherein the thermoplastic elastomer component comprises at least one olefin-based elastomer (see claim 12). Regarding claim 16, US 11931220 discloses wherein the dental treatment composition includes a dental bleaching agent (see claim 16). Regarding claims 18-22. US 11931220 discloses a dental treatment device, comprising: a barrier layer formed from a composition comprising greater than 40% and up to 95% by weight of a wax component and a thermoplastic elastomer component blended with the wax component, wherein the composition is substantially free of ethylene-vinyl acetate copolymer (EVA); wherein the barrier layer forms an unobstructed application surface of the device to which a composition is applied (no obstruction or other structures are recited) and a dental treatment composition adjacent to or impregnated within the barrier layer and in directed contact with the application surface, wherein the barrier layer is a dental tray or a strip and has a maximum wall thickness of less than 1 mm (per claim 18; see claim 21); wherein the dental tray is deformable by application of an external force and maintains its shape without significant deformation in the absence of an external force at 25 C (e.g. plastically deformable; per claim 19; see claim 21); wherein the barrier layer has a wall thickness in a range of about 0.09 mm to about 0.75 mm, about 0.1-0.5 mm or about 0.15-about 0.35 mm (per claims 20-22; see claim 21). Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 18-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 18, the term “wherein the barrier layer forms an unobstructed application surface of the dental treatment device to which a dental treatment composition is applied” lacks support in the original disclosure and as such is deemed new matter and must be removed. Specifically, the original disclosure makes no mention of an unobstructed application surface, and does not provide any support for the negative limitation of the application surface specifically being unobstructed. Deletion is required. Claims 19-22 are rejected based on their dependency on a previously rejected claim. 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. Claims 1-12, and 18-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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. Regarding claim 1, the term “an external force at a temperature of 25 C” is indefinite as it is unclear if the term “external force” refers to the previously recited external force, or another force. As best understood, based on the correction of claim 13, the term intends to recite another force. Clarification is required. Regarding claim 10, the term “at room temperature” is indefinite, as it is unclear whether the term should refer back to the now recited 25 degree C in claim 1, or if it refers to another temperature. As best understood by the Examiner, both terms refer to the same room temperature, however the same term should be used throughout the claims to describe the same thing throughout the claim set. Clarification is required. Regarding claim 18, the term “wherein the barrier layer forms an unobstructed application surface” is indefinite as it is unclear what specifically would or would not be considered “unobstructed”. As explained above, the term is unsupported in the original disclosure and as such the meets and bounds of the claim term are indefinite. Correction is required. All other claims not specifically addressed above are rejected based on their dependency on a previously rejected claim. Claim Rejections - 35 USC § 103 The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). Claims 1-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanigan (WO 2013/173100 A1), as evidenced by US 61/647,632 (priority application; see attached Specification; all citations directed thereto), in view of Kanbara (JP 2009/084326 A; see attached Machine Translation). Regarding claim 1, Flanigan discloses a dental tray (70; see Figs. 3b-4; Specification of 61/647632 page 10, lines 15-19 and page 12, lines 37 through page 13, line 2), comprising: a composition comprising a wax component and a thermoplastic elastomer component blended with the wax component (see page 5, lines 21-23), wherein the composition is substantially free of ethylene-vinyl acetate copolymer (EVA) (see citations above, no EVA is recited), wherein the composition is formed into a barrier layer (see citations above; barrier layer interpreted as laminated structure which forms the tray, which in part, is formed from the composition as claimed) forming at least an interior surface of the dental tray (see Figs above; as barrier layer, interpreted as explained above, is formed into the tray), wherein the dental tray is deformable by application of an external force and maintains its shape without significant deformation in the absence of an external force at a temperature of 25 C(e.g. room temperature; implicit in order to be used and as the same composition is described; see page 1, lines 19-24; page 4, lines 8-11, 17-33; page 11, lines 23-25, 29-31; page 12, lines 6-7, 17). Flanigan further discloses wherein the wax component is selected from the group consisting of petroleum wax, distilled wax, synthetic wax, mineral wax, vegetable wax, and animal wax (see page 6, lines 23-29 and page 5, lines 6-7; per claim 2); wherein the petroleum wax comprises at least one of paraffin wax, microcrystalline wax, or intermediate wax (see citations above; per claim 3); wherein the thermoplastic elastomer component comprises at least one olefin-based elastomer (see citations above and page 6, lines 1-23; per claim 8); wherein the at least one olefin-based elastomer is selected from the group consisting of ethylene-, propylene-, and butylene-based elastomers (e.g. SBS or SEBS, see citations above; per claim 9); wherein the dental tray comprises at least one sidewall (e.g. vertical surfaces) and a bottom wall (horizontal/occlusal surfaces; see Fig. 3b and 4) adjacent to and extending laterally from the at least one sidewall, wherein the dental tray has a thickness in a range of about 0.025 mm to less than 1.5 mm (see page 4, lines 12-16; per claim 11); and further comprising a dental treatment composition adjacent to or impregnated within the barrier layer (see citations above, Fig. 4 and page 7, line 24-page 10, line 19; per claim 12). Regarding claims 4-7, the Examiner notes the claims depend from claim 2, and the Examiner choses the option of a petroleum wax at claim 2 to meet the limitations thereof (see above). As such, the species of waxes of claims 4-7 of the non-elected genus of waxes of claim 2 (e.g. distilled wax, synthetic wax, mineral wax, vegetable wax and animal wax) are not required, as the choice of the particular wax genus is not positively required in each of claims 4-7 (nevertheless, see citations above regarding the type of wax selected). Flanigan, however, does not teach wherein the wax component is present at a weight percent of greater than 40 and up to 95% of the composition, or wherein the composition comprises at least 50% by combined weight of the wax and TPE component as required. Kanbara, however, teaches a similar dental barrier layer composition comprising greater than 40% and up to 95% by weight of a wax component and a thermoplastic elastomer blended with the wax component (see claim 1; machine translation). Additionally, Kanbara encompasses embodiments where the wax weight percent is greater than 50%. Accordingly, in embodiments where the wax weight percent is greater than 50%, the combined weight percent of the wax and TPE would be greater than 50% as required. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Flanigan to include the wax component weight percentage as taught by Kanbara, as combined above, as such modification would merely involve the optimization of a result effective variable, which has been held to be within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results (see MPEP 2144.05(II)(A)). The Examiner notes that the particular wax component weight percent is a result effective variable dependent on the particular malleability and or rigidity required or desired of the device, dependent on the size, construction and or shape of the device for a particular patient. Additionally, the Examiner notes that the particular wax percent is described as merely preferable with no stated criticality in the instant specification (see [0035]). Still further, as noted above, should the device of Flanigan be modified with a weight percent of wax of more than 50%, as taught by Kanbara, as combined above, such embodiment would meet the limitation of the claimed wax percent and would additionally provide the composition with at least 50% by combined weight of the wax and TPE as required (since wax alone is 50% or greater, and the composition additionally includes some amount of the TPE). Regarding claim 10, Flanigan/Kanbara, as combined above, discloses all the features of the claimed invention, including wherein the tray is plastically deformable at room temperature and thermally stable at a temperature up to at least 40C (see page 4, lines 21-22), and additionally would be plastically deformable at room temperature and thermally stable at a temperature up to at least 40C as Flanigan/Kanbara, as combined above, discloses the same composition as claimed, which would have the same properties thereof. Regarding claim 13, Flanigan discloses a dental treatment device, comprising: a strip (see Figs. 2a/b and specification page 1, lines 25-32; page 3, line 26 through page 4, line 7; page 11, lines 10; page 13, lines 5-10) formed from a composition comprising a wax component and a thermoplastic elastomer component blended with the wax component (see citations above), wherein the composition is substantially free of ethylene-vinyl acetate copolymer (EVA) (no EVA recited); and a dental treatment composition adjacent to or impregnated within the strip (see citations above), wherein the strip is deformable by application of an external force and maintains its shape without significant deformation in the absence of another external force at a temperature of 25C (see citations and explanation above). Flanigan further discloses wherein the wax component is selected from the group consisting of petroleum wax, distilled wax, synthetic wax, mineral wax, vegetable wax, and animal wax (see page 6, lines 23-29 and page 5, lines 6-7; per claim 14); wherein the thermoplastic elastomer component comprises at least one olefin-based elastomer (see citations above and page 6, lines 1-23; per claim 15); wherein the dental treatment composition includes a dental bleaching agent (see page 7, lines 24-37; per claim 16); and wherein the strip is initially flat and sufficiently flexible to be placed over and wrapped around at least a portion of a user’s teeth, and wherein the strip has a thickness in a range of about 0.025 mm to less than 1.5 mm (see citations above; per claim 17). Flanigan, however, does not teach wherein the wax component is present at a weight percent of greater than 40 and up to 95% of the composition, or wherein the composition comprises at least 50% by combined weight of the wax component and the TPE as required. Kanbara, however, teaches a similar dental barrier layer composition comprising greater than 40% and up to 95% by weight of a wax component and a thermoplastic elastomer blended with the wax component (see claim 1; machine translation). Additionally, Kanbara encompasses embodiments where the wax weight percent is greater than 50%. Accordingly, in embodiments where the wax weight percent is greater than 50%, the combined weight percent of the wax and TPE would be greater than 50% as required. Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Flanigan to include the wax component weight percentage as taught by Kanbara, as combined above, as such modification would merely involve the optimization of a result effective variable, which has been held to be within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results (see MPEP 2144.05(II)(A)). The Examiner notes that the particular wax component weight percent is a result effective variable dependent on the particular malleability and or rigidity required or desired of the device, dependent on the size, construction and or shape of the device for a particular patient. Additionally, the Examiner notes that the particular wax percent is described as merely preferable with no stated criticality in the instant specification (see [0035]). Still further, as noted above, should the device of Flanigan be modified with a weight percent of wax of more than 50%, as taught by Kanbara, as combined above, such embodiment would meet the limitation of the claimed wax percent and would additionally provide the composition with at least 50% by combined weight of the wax and TPE as required (since wax alone is 50% or greater, and the composition additionally includes some amount of the TPE). Regarding claims 18-19, Flanigan discloses a dental treatment device (see Figs. 2-4 and citations above), comprising: a barrier layer (sheet or tray; barrier layer interpreted as laminated structure which forms the tray, which in part, is formed from the composition as claimed) formed from a composition (at least in part) comprising a wax component and a thermoplastic elastomer component blended with the wax component (see citations above), wherein the composition is substantially free of ethylene-vinyl acetate copolymer (EVA) (no EVA recited), wherein the barrier layer forms an unobstructed application surface of the dental treatment device to which a dental treatment composition is applied (e.g. composition is applied to surface of sheet or tray, see below; additionally as barrier layer is interpreted as the laminated structure forming the tray, which in part is formed by the composition, the barrier layer therefor forms an unobstructed application surface to which the composition can be applied, such that the composition is in direct contact with the application surface (e.g. the outer layer of the tray); and the dental treatment composition adjacent to or impregnated within and in direct contact with the application surface of the barrier layer (see citations and explanation above), wherein the barrier layer is a dental tray or a strip (see Figs. 2-4) and has a maximum wall thickness of less than 1 mm (see page 4, line 4; “about 1mm”). The Examiner notes that it has been held that the term “about” allows for values slightly above and below the cited value, and as such, the claimed range overlaps with the prior art range. The Examiner further notes that a prima face case of obviousness exists when the claimed range overlaps or lies inside ranges disclosed by the prior art (see MPEP 2144.05(I). Flanigan further discloses wherein the dental treatment device is deformable by application of an external force and maintains its shape without significant deformation in the absence of another external force at a temperature of 25 C (see citations and explanation above; per claim 19). Flanigan, however, does not teach wherein the wax component is present at a weight percent of greater than 40 and up to 95% of the composition as required. Kanbara, however, teaches a similar dental barrier layer composition comprising greater than 40% and up to 95% by weight of a wax component and a thermoplastic elastomer blended with the wax component (see claim 1; machine translation). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Flanigan to include the wax component weight percentage as taught by Kanbara, as combined above, as such modification would merely involve the optimization of a result effective variable, which has been held to be within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results (see MPEP 2144.05(II)(A)). The Examiner notes that the particular wax component weight percent is a result effective variable dependent on the particular malleability and or rigidity required or desired of the device, dependent on the size, construction and or shape of the device for a particular patient. Additionally, the Examiner notes that the particular wax percent is described as merely preferable with no stated criticality in the instant specification (see [0035]). Claims 18-22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Flanigan et al in view of Kanbara, as combined above, further in view of Lewis et al (US 2010/0028829 A1). Regarding claims 20-22, Flanigan/Kanbara, as combined above, discloses all the features of the claimed invention, as explained above (including those of claim 19), but does not teach wherein the wall thickness is in a range of about 0.09 to about 0.75 mm, about 0.1 to about 0.5 mm, or about 0.15 to about 0.35 mm (per claims 20-22). Additionally, the Examiner notes that the particular thickness of the device is a result effective variable dependent on the desired adaptability, strength, comfort and or support desired for the device, which may vary based on a particular patient or patient condition. Further, the Examiner notes that the instant specification describes the particular thickness as merely preferable, lacking any specific criticality (see [0058]). Lewis, however, teaches a barrier layer in the form of a dental tray or strip (see abstract), which can be formed of a blend of a wax component and a polyolefin (see [0049], with a thickness of 0.03 to 1 mm (see [0056]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Flanigan/Kanbara, as combined above to provide a thickness as taught by Lewis, as such modification would merely involve the optimization of a result effective variable, which has been held to be within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results (see MPEP 2144.05(II)(A)). Further, the Examiner notes that a prima facie case of obviousness exists when the claimed range overlaps or lies inside ranges disclosed by the prior art (see MPEP 2144.05(I). Additionally, regarding claim 18, should Applicant traverse the Examiner’s position above, regarding Flanigan/Kanbara disclosing the maximum wall thickness being less than 1 mm as required, Lewis, teaches a barrier layer in the form of a dental tray or strip (see abstract), which can be formed of a blend of a wax component and a polyolefin (see [0049], with a thickness of 0.03 to 1 mm (see [0056]). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the invention to modify the device of Flanigan/Kanbara, as combined above to provide a thickness as taught by Lewis (less than 1 mm), as such modification would merely involve the optimization of a result effective variable, which has been held to be within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results (see MPEP 2144.05(II)(A)). Further, the Examiner notes that a prima facie case of obviousness exists when the claimed range overlaps or lies inside ranges disclosed by the prior art (see MPEP 2144.05(I). Flanigan/Kanbara/Lewis, as combined above under the alternate interpretation of claim 18, further discloses the limitations of claim 19 (see Flanigan), and the specific ranges of claim 20-22 (as disclosed by Lewis, see above). 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 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 EDWARD MORAN whose telephone number is (571)270-5349. The examiner can normally be reached Monday-Friday 7 AM-4 PM EST. 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, Eric Rosen can be reached at 571-270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /EDWARD MORAN/Primary Examiner, Art Unit 3772
Read full office action

Prosecution Timeline

Jan 31, 2024
Application Filed
Nov 03, 2025
Non-Final Rejection mailed — §103, §112
Feb 25, 2026
Response Filed
May 08, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
41%
Grant Probability
99%
With Interview (+60.6%)
3y 6m (~1y 2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 637 resolved cases by this examiner. Grant probability derived from career allowance rate.

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