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 .
Election/Restrictions – Withdrawn
Applicant’s election with traverse of 1-16 in the reply filed on 08/21/2025 is acknowledged. However, in view of the prior art, as well as the claim amendments and arguments submitted 08/21/2025, the examiner is withdrawing the restriction requirement. Accordingly, the claims under current examination are claims 1-20.
Claim Interpretation
Claim 11 recites “wherein the flexible and stretchable material is a poly vinyl pyrrolidone matrix.” The examiner is interpreting this to mean the first layer and the second layer of claim 1 are polyvinylpyrrolidone.
Claim 12 recites “wherein the flexible and stretchable material is a polyacrylate or a polyacrylate copolymer.” The examiner is interpreting this to mean the first layer and the second layer of claim 1 are a polyacrylate or a polyacrylate copolymer.
Claim Rejections - 35 USC § 112
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 8 and 18 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.
Instant claim 8 recites “the hydrogel includes water in a range from about 5% to about 50%”. It is unclear how the percent range is measured (e.g., v/w or w/w). For the purposes of examination, the percent range will be interpreted as percent by weight.
The term “configured for” in claim 18 is a relative term which renders the claim indefinite. The term “configured for” 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 unclear how the how the material is “configured” for self-application. For the purposes of examination, “configured for” will be interpreted as “capable of.”
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1) Claims 1-6, 9, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong et al. (KR 100550065 B1, publication date 02/08/2006; citing English translation).
Hong discloses an adhesive for whitening teeth “comprising one or more hydrogel matrix layers, tooth attachment site protective layers, and exposed site protective layers" [abstract]. In one example, see first paragraph of page 7, the hydrogel is made with polyacrylic acid (i.e., polyacrylate and water swellable polymer1; limitation of instant claim 3, 6, and 9), and includes hydrogen peroxide (i.e., whitening agent; limitation of instant claim 13) and sodium stearate (i.e., a salt; limitation of instant claim 15). The hydrogel is applied to a PET film (polyethylene terephthalate) and laminated to a PE film (polyethylene; limitation of instant claim 2). According to Hong the polyethylene terephthalate film is an attachment site protective layer (i.e., release liner, limitation of instant claims 4 and 5) [p. 5, last paragraph].
The prior art is anticipatory insofar as it discloses a tape for use in the mouth comprising two layers that are laminated together and that include a first layer polyethylene polymer film and a second layer of polyacrylic acid, a water swellable hydrogel material, wherein a whitening agent and salt are associated with the hydrogel. The oral tape further comprises a third layer of polyethylene terephthalate as a release layer. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to have the same properties, i.e. flexible and stretchable.
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 7, 8, 14, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (KR 100550065 B1, publication date 2/8/2006; citing English translation) as applied to claims 1-6, 9, 13, and 15 above.
Regarding instant claims 7 and 8, Hong discloses a material for the hydrogel is carboxymethyl cellulose (i.e., alkylated derivative of cellulose) which may be present in amounts from 0.01% to 70% [p. 4, paragraph 9].
It would have been obvious to one or ordinary skill in the art, at the time of filling, to have selected carboxymethyl cellulose, the alkylated derivative of cellulose, as the hydrogel material because Hong discloses it is an option. MPEP 2144.07. Additionally, one of ordinary skill in the art would have appreciated that, considering the discloses range of carboxymethyl cellulose, the water content of the hydrogel would range from 99.99% to 30%. As a result, the percent range of the water content in the prior art overlaps with the instantly claimed range and a prima facie case of obviousness exist. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have produced the layered flexible and stretchable material disclosed by Hong with a hydrogel comprising an alkylated derivative of cellulose and with a water content as instantly claimed.
Regarding instant claim 14, Hong discloses the hydrogel may contain medicinal ingredients [p. 5, paragraph 5] and is an adhesive [p. 4, first paragraph]. It would have been prima facie obvious for a person having ordinary skill in the art at, at the time of filling, to have selected and combined known components for their established functions with predictable results by following the teachings of Hong . MPEP 2143 and 2144.06(I). Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have produced the adhesive of the prior art such that it provided a medicinal delivery system.
Regarding instant claim 17-19, Hong discloses the hydrogel layer may comprise gum disease prevention components [p. 5, para. 5]. One of ordinary skill in the art would have understood a gum disease prevention component to be a therapeutic agent for transmission to the soft tissue of the mouth.
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the gum disease prevention component with the oral adhesive taught by Hong above. One would have been motivated and had an expectation of success in doing so because Hong discloses the gum disease prevention component is a desirable additive. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, 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, at the time of filling, to have produced the therapeutic sticker from the oral adhesive taught by Hong. The oral adhesive taught by Hong, and discussed above, comprises a flexible material which is made up of a polymer layer and a hydrogel material, and is infused with an ingredient for oral care (whitening agent) and salts. The therapeutic sticker, which would have been obvious at the time of filling, further comprises a therapeutic agent for transmission to the soft tissue of the mouth (i.e., gum disease prevention component).
2) Claims 16 and 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hong et al. (KR 100550065 B1, publication date 2/8/2006; citing English translation) as applied to claims 1-9, 13-15 and 17-19 above, and further in view of Giniger et al. (US 2007/0122362 A1, publication date 5/31/2007).
Hong, which is taught above, differs from instant claims 16 and 20 insofar as it does not teach the length or width of the film and does not teach a semi-circular shape. Hong does teach the thickness to be between 10 and 100 µm (i.e. 0.001 cm to 0.1 cm; p. 6, paragraph 4) and that it may be cut into a shape [p. 6, paragraph 7].
Giniger discloses a “hydrophilic cohesive hydrogel products which are adapted for a variety of oral uses” [0018] such as whitening teeth [abstract]. Giniger discloses the hydrogel product may be short strips that are about 8 mm wide and about 24 mm long (i.e. 0.8 cm and 2.4 cm) [paragraph 32].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to produce the film discloses by Hong in the dimensions disclosed by Giniger. One would have been motivated to do so because Hong teaches the film for whitening teeth should be cut to size but does not disclose a specific size. One would have had an expectation of success because Giniger discloses a suitable dimensions for a tooth whitening film. The result would have been a film, as taught by Hong, with a length of 2.4 cm, a width of 0.8 cm and a thickness between 0.001 cm to 0.1 cm. In the case, such as the present case, where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have produced a material with at least a polymer layer and a hydrogel material layer with the dimensions instantly claimed.
Regarding instant claim 20, Giniger discloses the hydrogel can be in a semi-circular shape [page 5, images]. It would have been obvious to one of ordinary skill in the art, at the time of filling, to have cut the film disclosed in Hong into a semi-circular shape following Giniger’s disclosure. One would have been motivated to do so because Hong teaches the film should be cut to size but does not disclose a specific size. One would have had an expectation of success because Giniger discloses a similar product that is shaped in a semi-circle. Additionally, in combining these elements one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Therefore, would have been obvious to one of ordinary skill in the art, at the time of filling, to have cut the film and therapeutic sticker taught by Hong into a semicircular shape. Because the prior art contains substantially the same components as instantly claimed, it would have been expected to have the same properties, i.e. capable of adhering to the soft tissue inside the mouth.
3) Claims 1, 6, 7, 10-15 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 2004/0224007 A1, publication date 9/11/2004).
Regarding instant claims 1, 6, 7 and 10-12, Zhang discloses an oral “drug delivery device comprises a water-dissolvable backing layer, an adhesive layer adjacent to at least a portion of the backing layer, and an active layer” (abstract). The backing layer is a hydrogel comprising at least on component selected from ethyl cellulose (instant claims 6 and 7), polyvinylpyrrolidone (limitation of instant claim 11), polyacrylic acid (limitation of instant claim 12), and derivatives thereof (limitation of instant claim 10) [p. 9, claim 7]. The adhesive layer may comprise polyvinyl pyrrolidone (limitation of instant claim 11) and/or polyacrylic acid polymer (limitation of instant claim 12) [p. 9, claim 5].
Zhang is not anticipatory because it does not disclose all the instantly claimed components in one example or embodiment.
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, at the time of filling, to have selected and combined known components for their established functions with predictable results by following the teachings of Zhang . MPEP 2143 and 2144.06(I).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have produced an oral adhesive comprising two or more layers (i.e., water-dissolvable backing layer, an adhesive layer, and an active layer) laminated together. Wherein the first and second layers (i.e., the flexible and stretchable material) are either polyacrylic acid (i.e., a polyacrylate) or a polyvinyl pyrrolidone matrix.
Similarly, it would have been obvious to one of ordinary skill in the art, at the time of filling, to have produced the oral adhesive taught by Zhang comprising ethyl cellulose, an alkylated derivative of cellulose, and its derivatives as the hydrogel.
Regarding instant claim 13 and 14, Zhang discloses the device may contain morphine (i.e., pain reliever) [p. 9, claim 2]. As a result, the device would have had adhesive properties and provided a medicinal delivery system.
Regarding instant claim 15, Zhang discloses the device may contain plasticizers [p. 9, claim 8].
Regarding instant claim 17-19, Zhang discloses the active layer to be a matrix material [0066] which may be polyacrylic acids (i.e. an acrylic polymer) [0069] and may further include sodium laurylsulfate (i.e., a salt) [0068] and flavorants. Flavoring agents are an ingredient to improve oral care according to the instant specification at page 19, paragraph 2.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). It would have been obvious to one of ordinary skill in the art to have formed this active layer as a hydrogel because Zhang discloses a polyacrylic acid hydrogel. The result would have been a material comprising two or more layers including a first layer of polymer film (i.e., adhesive layer) and a second layer of hydrogel material (i.e., active layer) with a therapeutic agent associated with the hydrogel, where the hydrogel is an acrylic polymer (i.e. polyacrylic acids) and further includes a salt (i.e. sodium laurylsulfate) and an ingredient to improve oral care. Wherein the therapeutic agent is for transmission to the soft tissue of the mouth.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11, 13-18 and 21-26 of copending Application No. 17/581,825 and in view of Hong et al. (KR 100550065 B1, publication date 2/8/2006; citing English translation), Zhang (US 2004/0224007 A1, publication date 9/11/2004) and Giniger et al. (US 2007/0122362 A1, publication date 5/31/2007).
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 1), for application to braces (claim 1). The material comprises a dissolvable polymer (i.e. polyvinyl pyrrolidone).
The copending claims do not disclose all the specific polymers instantly claimed.
Hong discloses an adhesive for whitening teeth “comprising one or more hydrogel matrix layers, tooth attachment site protective layers, and exposed site protective layers" [abstract]. In one example, see first paragraph of page 7, the hydrogel is made with polyacrylic acid (i.e., polyacrylate and water swellable polymer2; limitation of instant claim 3, 6, 9 and 19), and includes hydrogen peroxide (i.e., whitening agent; limitation of instant claim 13 and 17) and sodium stearate (i.e., a salt; limitation of instant claim 15 and 17). The hydrogel is applied to a PET film (polyethylene terephthalate) and laminated to a PE film (polyethylene; limitation of instant claim 2). According to Hong the polyethylene terephthalate film is an attachment site protective layer (i.e., release liner, limitation of instant claims 4 and 5) [p. 5, last paragraph].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the polymers of Hong with the adhesive disclosed by the copending claims. In combining these elements, one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
Regarding instant claims 7 and 8, Hong discloses a material for the hydrogel is carboxymethyl cellulose (i.e., alkylated derivative of cellulose) which may be present in amounts from 0.01% to 70% [p. 4, paragraph 9].
One of ordinary skill in the art would have appreciated that, considering the discloses range of carboxymethyl cellulose, the water content of the hydrogel would range from 99.99% to 30%. As a result, the percent range of the water content in the prior art overlaps with the instantly claimed range and a prima facie case of obviousness exist. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
The copending claims and Hong do not disclose the flexible stretchable material (all layers) are polyvinylpyrrolidone or polyacrylate.
Zhang discloses an oral “drug delivery device comprises a water-dissolvable backing layer, an adhesive layer adjacent to at least a portion of the backing layer, and an active layer” (abstract). The backing layer is a hydrogel comprising at least on component selected from ethyl cellulose (instant claims 6 and 7), polyvinylpyrrolidone (limitation of instant claim 11), polyacrylic acid (limitation of instant claim 12), and derivatives thereof (limitation of instant claim 10) [p. 9, claim 7]. The adhesive layer may comprise polyvinyl pyrrolidone (limitation of instant claim 11) and/or polyacrylic acid polymer (limitation of instant claim 12) [p. 9, claim 5].
It would have been obvious to one of ordinary skill in the art, at the time of filling, to have combined the polymers of Zhang with the adhesive disclosed by the copending claims. In combining these elements, one would have expected nothing more than predictable results because, when combined, each prior art element would have performed the same function as it had separately. See MPEP 2143, Exemplary Rationale A.
The copending claims, Hong and Zhang do not disclose a semicircular shape.
Regarding instant claim 20, Giniger discloses an oral adhesive comprising a hydrogel can be in a semi-circular shape [page 5, images].
It would have been obvious to form the adhesive of the copending application into a semicircle because Giniger discloses a semicircle is a suitable shape. MPEP 2144.07.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure. J. Elliott et al., Polymer, Volume 45, Issue 5, 2004, Pages 1503-1510 is pertinent for teaching that polyacrylic acids in hydrogels are a swellable polymer.
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.
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, Frederick Krass can be reached on 571-272-0580. 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.
/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
1 J. Elliott et al., Polymer, Volume 45, Issue 5, 2004, Pages 1503-1510
2 J. Elliott et al., Polymer, Volume 45, Issue 5, 2004, Pages 1503-1510