825DETAILED 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 .
Applicants’ arguments, filed 9/19/2025, have been fully considered. Rejections and/or objections not reiterated from previous office action are hereby withdrawn.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 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 “underlying surface” in claim 11 is a relative phrase which renders the claim indefinite. The phrase “underlying surface” 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 phrase such that the artisan would reasonably appreciate the metes and bounds of what is encompassed by it. It is not clear what may be an “underlying surface” and still meet the requirement of the claim.
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 stand 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 strip of flexible and stretchable material is a dissolvable polymer having an outer layer, another layer with at least the ingredient, and an inner adhesive layer adjacent the layer having at least the ingredient that adheres to the underlying surface.” The Examiner was also unable to find support for the recitations of newly added claims 21-26. 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.’”).
The specification does not appear to disclose a product with more than one layer. And even though such a layered device could possibly be considered obvious in view of the disclosure that the product may comprise natural or synthetic polymers [p. 9, 2nd full para.], however, there is nothing in the specification that would necessitate multiple layers for the instant strip.
Furthermore, the specification does not support a product for use on an underlying surface, in general, (other than teeth, mouth, gums [p. 9, 1st full para.], soft tissue [p. 9, 2nd full para.] and braces [p. 9, 3rd full para,]). In fact, the disclosure as originally filed does not disclose that the product may be used outside the oral cavity at all. The phrase “including the mouth” suggest application to surfaces other than the mouth, which causes the claim to read on undisclosed surfaces.
Therefore, a product with multiple layers for use on “an underlying surface” is considered new matter because layers, and application to an underlying surface, generally, are not necessarily present in the disclosure as originally filed.
Response to Arguments
Applicant argues there is support for multilayer aspect of the claimed phrase “wherein the strip of flexible and stretchable material is a dissolvable polymer having an outer layer, another layer with at least the ingredient, and an inner adhesive layer adjacent the layer having at least the ingredient that adheres to the underlying surface” in the specification. Specifically, applicant cites: “The strips 30 may be double sided and may be and may be made of a poly vinyl pyrrolidone matrix that contains specified ingredients, such as natural anti-irritants” [p. 9, lines 24-25].
This argument is not persuasive. While the cited portion of the specification discloses a double sided strip, there is no mention of multiple layers. The examiner is also unable to find support for a multilayered strip in the specification as whole. Moreover, one of ordinary skill in the art, upon reading the application as originally presented, would not readily envisage a multilayer oral strip because there is nothing to suggest more than one layer.
Applicant has not indicated how the newly added claims 21-26 are supported by the disclosure as originally filed.
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.
Claims 11, 21-23 and 25 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biegajski et al. (US 5700478, issue date 12/23/1997).
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). The film is "suitable for affixing to the dental surface or to the surface of various forms of prosthesis" (col. 3, lines 50-53) and conforms smoothly to the oral cavity (i.e. flexible and stretchable; col. 6, lines 66-67; see also col. 8, lines 1-5). In one embodiment, for delayed onset delivery of the active agent, 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 an underlying surface; col. 16, lines 52-57 and figure 2).
The prior art is anticipatory insofar as it teaches a flexible and stretchable dissolvable strip comprising a dissolvable polymer having an outer layer, another layer with at least one ingredient, and an inner adhesive layer adjacent to the layer with at least on ingredient that adheres to an underlying surface. 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. having properties that permit it to conform to an underlying surface (instant claim 11), 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).
Response to Arguments
Applicant argues that Biegajski does not teach the material is stretchable and so is not anticipatory.
This argument is not persuasive. The prior art teaches a flexible stretchable film insofar as it teaches: “Preferred water-soluble pressure sensitive adhesive 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” (see col. 8, lines 1-5). In order to conform smoothly to an oral surface, which are often irregular, the oral film would have to be stretchable. Irregularities in a surface cause the distance between two points, as measured along the surface, to differ from the distance between the same two points as measured by a straight line. In other words, when an oral film is applied to an irregular surface it would have to be able to stretch in order to compensate for the varied distances along the surface in order to conform smoothly to that surface. Therefore, considering the broadest reasonable interpretation of “stretchable” (i.e., any amount of stretch) and the disclosure that the oral film conforms smoothly to the oral surface, one would have expected the oral film of the prior art to be a stretchable oral film.
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 13-15, 17, 18, 24 and 26 stand 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, 21-23 and 25 above and evidenced by McIntyre (Hydroxypropylcellulose HPC, 1982, Food Hydrocolloids, vol. III, p 117).
Biegajski, which is taught above, differs from instant claims 13-15, 17, 18, 24 insofar as it does not disclose the film taught above to be translucent, double sided, food grade, pre-cut, dissolvable or hours or minutes, or the specific active agent included in the film.
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 meet 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; limitation of 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 laminated 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 15, Biegajski discloses that one adhesive formulation is translucent (col. 14, lines 36-37). Biegajski also discloses that the polymer layer may be made from hydroxypropyl cellulose (HPC) (col. 11, lines 1-2). Edible films made with HPC were known to be clear and flexible, as evidenced by McIntyre on page 117 at the third to last paragraph. Biegajski does not specifically combine the translucent adhesive layers and the two HPC layers, as instantly claimed. However, given the disclosure of each component individually, it would have been obvious to a person having ordinary skill in the art at the time of filing to have combined the known components for their established functions with predictable results. See MPEP 2143 and 2144.06(I).
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.
Regarding instant claim 25, while instant claim 25 is anticipated it is also 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.
Response to Arguments
Applicant argues that Biegajski does not teach the material is stretchable.
These arguments are not persuasive. The claims stand rejected for the same reasons above and of record.
2) Claims 16 stands rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, issue date 12/23/1997), as evidenced by evidenced by McIntyre (Hydroxypropylcellulose HPC, 1982, Food Hydrocolloids, vol. III, p 117) as applied to claims 11, 13-15, 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.
Response to Arguments
Applicant asserts Allred fails to cure the noted deficiencies of Biegajski set forth above.
These arguments are not persuasive. The claims stand rejected for the same reasons above and of record.
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 and 23 stand 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 of wound care because it is a flexible 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
Applicant asserts the skilled artisan would not have been motivated by the applied references to reach the instantly claimed product for use on an underlying surface and asserts the double patenting rejection of claims 11, 13 and 23 should be withdrawn or held in abeyance.
These arguments are not persuasive. The claims stand rejected for the same reasons above and of record.
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.
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/C.T.W./Examiner, Art Unit 1612
/WALTER E WEBB/Primary Examiner, Art Unit 1612