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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/29/2026 has been entered.
Applicants’ arguments, filed 04/29/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
Instant claim 11 recites “wherein the stretchable material has a stretchable nature that provides a cantilever effect, permitting the material to cover a larger surface area than an unstretched shape of the material and adding retention of the tape to the soft tissue, teeth, or braces”. The definition of cantilever is “a projecting beam or member supported at only one end: such as a: a bracket-shaped member supporting a balcony or a cornice [or] b: either of the two beams or trusses that project from piers toward each other and that when joined directly or by a suspended connecting member form a span of a cantilever bridge” (see cantilever, Merriam-Webster [retrieved 5/26/2026], https://www.merriam-webster.com/help/citing-the-dictionary). Given the instant material is flexible the examiner is interpreting cantilever effect as the ability of the tape to remain suspended and unsupported when stretched over an area and adhered to each side of that area. This interpretation corresponds to definition “b” of Merriam-Webster and fulfils the instantly claimed requirement of “permitting the material to cover a larger surface area than an unstretched shape”.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 11, 13-18 and 21-26 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.
The phrase “the stretchable material has a stretchable nature that provides a cantilever effect” (emphasis added) in claim 11 is a relative term which renders the claim indefinite. The term “a stretchable nature” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what is meant by this term such that the artisan would reasonably appreciate the metes and bound of what is encompassed by it. It is not clear how far from the base stretchable structure one can deviate and still meet the requirement of the claim. Furthermore, it is unclear what nature of stretch provides a cantilever effect. For the purposes of examination, the examiner will interpret “a stretchable nature that provides a cantilever effect” to be a material that is stretchable.
Claim Rejections - 35 USC § 112 -- New Matter
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.
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.
Claims 11, 13-18 and 21-26 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.
Claim 11 recites the amended phrase “wherein the stretchable material has a stretchable nature that provides a cantilever effect” (emphasis added). The Examiner was also unable to find support for the recitations of newly added claims 21, 23-26. The amendments constitute new matter insofar as they were not supported by the disclosure as originally filed.
To satisfy the written description requirement, “the missing descriptive matter must necessarily be present in the [original] application’s specification such that one skilled in the art would recognize such a disclosure.” Tronzo v. Biomet, Inc., 156 F.3d 1154, 1159 (Fed. Cir. 1998).
Even if the recitation were obvious over the disclosure of the Specification, that is not the standard for satisfaction of the written description requirement. See In re Huston, 308 F.3d 1267, 1277 (Fed. Cir. 2002) (‘“Entitlement to a filing date does not extend to subject matter which is not disclosed, but would be obvious over what is expressly disclosed.’”).
Regarding instant claim 11, the only mention of a cantilever effect can be found at the second paragraph of page 7 of the specification as originally. While the disclosure supports a tape providing a cantilever effect, it does not disclose the cantilever effect is due to the stretchable nature of the tape. In fact the specification discloses “Bracket tape 30 may be designed in silicone to be attached to brackets initially in the first weeks of treatments where most uncomfortable soreness develops to avoid ulcerations in the vestibule, lip, and cheek area of the mouth. Tape 30 of this nature stays on better because it has a cantilever effect” [p. 7, para. 2]. Therefore, a cantilever effect due to the stretchy nature of the tape is not necessarily present because the material of the strip may also impact the cantilever effect, according to the specification.
Regarding instant claim 21 and 24-26, the examiner is not able to find mention of a strip that is activated contact with fluids, dissolution of the strip in hours or minutes, a strip able to withstand chewing for hours or minutes and a strip in the shape of a mouthguard.
Regarding instant claim 23, the narrow recitation of ulceration at pages 1 and 7 of the instant disclosure as originally filed does not support the breadth of the instantly claimed wound care. Additionally, all wound care is not necessarily present in the disclosure of ulcerations.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claims 11, 13-14, 17, 18, and 21-26 is rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, issue date 12/23/1997).
Regarding instant claims 11, 21-23 and 25, Biegajski discloses a device comprising water-soluble adhesive and one or more water soluble polymer layers provided as a dry film for applications in the oral cavity to deliver a breath freshening agent or substance for relief of sore throat [abstract]. In one embodiment, the film comprises a dissolvable upper layer not containing the substance (i.e. dissolvable outer layer), a middle substance-containing water soluble layer (i.e. another layer with at least one ingredient) and an adhesive layer which adheres to the mucosal surface (i.e. inner layer adjacent that adheres to soft tissue) [col. 16, lines 52-57 and figure 2]. Furthermore, Biegasjski discloses the preferred films “are very flexible, and are therefore capable of conforming to and adhering to contoured surfaces such as the gum or the roof of the mouth” [col. 8, lines 3-5]. According to Biegajski the flexibility of the film is represented by the elastic moduli which “entails measuring the tensile force per unit cross sectional area (stress) of a sample of the film during elongation of the sample at a fixed rate (strain)” (i.e., stretchable) [col. 32, lines 33-41]. Biegajski teaches that sufficiently flexible films have elastic moduli less than 1000 lb/in2 [col. 32, lines 46-52 & Figure 16].
Biegajski does not anticipate the instant claims because it does not expressly disclose that the embodiment having three layers is flexible.
However, given the disclosure of each component individually, it would have been prima facie obvious for a person having ordinary skill in the art at, before the effective filling date of the claimed invention, to have selected and combined known components for their established functions with predictable results by following the teachings of Biegajski. MPEP 2143 and 2144.06(I).
The flexible strip taught by Biegajski would have also been stretchable because, according to Biegajski, the elastic moduli of suitably flexible films are measured during elongation of the films. Therefore, one would have expected suitably flexible films to elongate (i.e., stretch). Additionally, because the films are stretchable one would have expected them to be capable of providing a cantilever effect according to the instant claims.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated a flexible and stretchable polymer strip having an outer layer, a middle layer comprising an active ingredient and an inner adhesive layer that adheres to soft tissue. Wherein the stretchable strip provides a cantilever effect as instantly claimed. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to possess the same properties and be capable of satisfying the same applications, i.e. activated by contact with fluids (instant claim 21), dissolvable by contact with fluids (instant claim 22), wound care (instant claim 23) and able to withstand chewing over hours or minutes (instant claim 25).
Regarding instant claim 13, Biegajski discloses substances that may be delivered using the film include peppermint oil (i.e. a breath freshener) [col 12, line 41].
Regarding instant claim 14 and 17, the film (i.e. strip) disclosed by Biegajski in the embodiment described above has two sides. Therefore, it is considered double sided and meets the requirements set forth by the instant limitation in instant claim 14 that “the strip is double sided”.
However, instant claim 14 is also obvious if “double sided” is interpreted as meaning the strip has adhesive on two opposite sides. Biegajski discloses the invention can be used as a dental prosthesis adhesive film [col. 14, line 39]. For use in this way, the adhesive film is die-cut into a shape (i.e. pre-cut length; instant claim 17) that conforms to the dental prosthesis [col. 14, lines 40-42]. Then, “the dry [adhesive] film is pressed onto the appropriate surface of the dental prosthesis so that it adheres. Then the dental prosthesis with the adhesive affixed is inserted into the correct position in the mouth and pressed against the mucosal surface until adhesion is achieved” [col 14, lines 39-49]. Biegajski also discloses that multi-layer films may be made by hand laminating the adhesive layers to the non-adhesive polymer layers [col. 18, lines 29-33].
It would have been obvious to one of ordinary skill in the art to at the time of filling to configure the delayed onset delivery embodiment described above comprising three layers to include an additional adhesive layer, such that the film or strip has an adhesive layer on two opposite sides. One would have been motivated to modified the film in this way to provide a dental adhesive strip with substance delivery capabilities. One would have had an expectation of success because applying the adhesive layer to the polymer layer was a known method of building the multi-layer films. Additionally, one would have had an expectation of success because the adhesive was disclosed to work in the substance delivery film and as a dental prosthetic adhesive. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to produce a double-sided dissolvable strip infused with an ingredient, as instantly claimed, which may be pre-cut into desired lengths.
Regarding instant claim 18, Biegajski discloses the water-soluble adhesive film and polymer layers, for delivering sore throat relief (i.e. medicinal deliver; abstract), are made with materials that are generally regarded as safe or national formulary certified, and therefore safe for ingestion [col 3, lines 30-34 and col 4, lines 65-67]. The examiner is interpreting material generally regarded as safe for ingestion to meet the requirements set forth by the instant limitation of “food grade polymer material”.
Regarding instant claim 21, Biegajski discloses the “active substance is released into the oral cavity as the active containing polymer layer dissolves” (i.e. activated by contact with fluid) [col. 5 lines 43-45].
Regarding instant claim 24, Biegajski discloses the adhesive device with one or more polymer layers dissolves completely within the oral cavity [col. 5, line 14]. Biegajski also discloses that in many applications the adhesive and polymer layers may deliver active substances in excess of 1 hour [col. 5, lines 24-27 and col 6, lines 26-31]. In other words, the device with an adhesive layer and polymer layers (i.e. dissolvable strip) is dissolvable over a period of minutes or hours.
Instant claim 25 would have also been obvious over Biegajski’s disclosure that the adhesive may be applied to the teeth [col 4, line 48] and that the film can provide continuous delivery of the medication for 4 hours [col. 5-6, lines 66-67 and 1-2 respectively]. It would have been expected that the film, as described by Biegajski, would have been able to withstand chewing for minutes or hours because of the extended delivery time and its application to the teeth.
Regarding instant claim 26, Biegajski discloses the adhesive may adhere to the teeth [col. 4, lines 47-48]. Biegajski also discloses the film may be cut to closely conform to the surface it will adhere onto [col. 14, lines 40-41] and that the film may be used to protect the mouth [col. 21, lines 10-15].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to cut the film in such a way to have been shaped like a mouthguard. Biegajski discloses the film may be cut to closely conform to the surface it will adhere onto. One surface the film will adhere onto is the surface of the teeth. Cutting the film to closely adhere to the teeth would have resulted in a mouthguard shape. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have produced the film as described above, in the shape of a mouthguard.
2) Claims 15 is rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, issue date 12/23/1997) as applied to claims 11, 13-14, 17, 18, and 21-26 above, and further in view of Kubo et al. (US20040214127A1, publication date 10/28/2004) and McIntyre (Hydroxypropylcellulose HPC, 1982, Food Hydrocolloids, vol. III, p 117).
Biegajski, which are taught above, differ from the instant claims insofar as they do not teach a clear or transparent film. However, Biegajski does discloses that one adhesive formulation is translucent (col. 14, lines 36-37). Biegajski also discloses that the non-adhesive polymer layers may be made from hydroxypropyl cellulose (HPC) (col. 11, lines 1-2).
Kubo relates to dental articles [title] and discloses “transparent or white semi-transparent materials such as ceramic bracket and plastic bracket have been used for the purpose of improving aesthetic appearance” [0005].
McIntyre discloses edible films made with HPC can be clear and flexible [p. 117, third to last paragraph].
It would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have combined the clear HPC films of McIntyre with the translucent adhesive layers of Biegajski. One would have been motivated because Kubo discloses transparent dental articles improve the aesthetic appearance. One would have had an expectation of success because Biegajski desire HPC films for the non-adhesive layers and McIntyre discloses the clear HPC films can be flexible. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined by known methods, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have formulated the flexible and stretchable strips, as taught above, to be translucent or clear.
3) Claims 16 is rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, issue date 12/23/1997) as applied to claims 11, 13-14, 17, 18, 21-26 above, and further in view of Allred et al. (US20160367348, publication date 12/22/2016).
Biegajski, which is taught above, differs from instant claim 16 insofar as it does not teach the product to be packaged or to have a shelf life of two years or more.
Allred discloses “packaging systems for improving long-term stability and shelf-life of a composition stored therein” [paragraph 10]. One “exemplary packaging system [is] for use in maintain the stability of an oral treatment composition” [paragraph 61], such as an adhesive [paragraph 71]. Allred also discloses that the “composition sealed within the container to exhibit good stability, even when stored at room temperature for 24 months or more” [paragraph 96].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have packaged the film taught by Biegajski in the packaging system disclosed by Allred. One would have been motivated to do so in order to improve long-term stability and shelf-life of the film. One would have had an expectation of success because the packaging system was disclosed for use with oral compositions, such as adhesives. Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have produced the film taught above in the sealed packaging system with its attendant shelf life of 2 or more years.
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.
Claim 11, 13-18 and 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of copending Application No. 17/958,294 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they both embrace a flexible and stretchable material infused with an ingredient (i.e. sorbitol; claim 13), with an adhesive (claim 14), for application to braces (claim 1). The material comprises a dissolvable polymer (i.e. polyvinyl pyrrolidones; claim 6). The product claimed in copending application ‘294 would have been capable of performing the instantly claimed functions, such as cantilever effect, because it is a flexible and stretchable product comprising a dissolvible polymer, an ingredient, and an adhesive, as instantly claimed.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
1) On page 5 of their remarks, Applicant argues that the Biegajski does not disclose an inherently stretchable material because there is no proof that the flexible materials of Biegajski would be stretchable.
This argument is not persuasive. As discussed above, Biegajski discloses that the flexibility of the films is determined by a process in which the films are elongated, i.e., stretched, and therefore the films must be stretchable (see Figure 16 & col. 32, lines 45-52]. Additionally, “[a]n elastic modulus is a fundamental property of an object or material that describes its ability to deform non-permanently under stress” (Smith, DeweSoft, 2025 [retrieved 5/26/26], https://dewesoft.com/blog/understanding-elastic-moduli). Therefore, the films desired by Biegajski also appear to be elastically stretchable insofar as their elastic moduli are disclosed.
2) On page 5-6 of their remarks, Applicant argues that the prior art does not teach a cantilever effect as instantly claimed.
This argument is moot in view of the new rejections set forth above.
3) On page 6 of their remarks, Applicant argues that the secondary references fail to cure the deficiencies of the primary reference, Biegajski.
This argument is not persuasive for the reasons discussed above and of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COLMAN WELLES whose telephone number is (571)272-3843. The examiner can normally be reached Monday - Friday, 8:30am - 5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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