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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “Fig. 10, 10” has been used to designate both “end view of Fig. 6” and a straw shaped chew because there are two Fig. 10 in the drawings. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
On page 3, the instant specification recites “Fig. 11 depicts a perspective view of an alternative chew according to the invention, with the chew being straw-shaped; Fig. 11 depicts an exploded view of the chew of Fig. 11;”.
This is a minor informality because the specification provides two explanations for the same figure and is understood to be a result of the mis-labeled figures (i.e., two Fig. 10) as discussed above.
Appropriate correction is required.
Claim Interpretation
The “neutral outer layer” of claim 2 is interpreted to mean an outer layer that does not carry a permanent ionic charge.
Claim 3 recites “the member is dissolvable over a period of minutes, hours or days” which is interpreted to mean the member dissolves over a period of minutes, hours or days.
Claim 4 recites “the member is dissolvable over a 72-hour period of time” which is interpreted to mean the member dissolves over a 72 hour period of time.
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 1-20 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 term “configured” in claim 1 is a relative term which renders the claim indefinite. The term “configured” 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. The term “configured” suggests modification of the flexible member, but neither the instant claims nor the specification disclose how the member is modified. It is not clear how far from the base flexible member structure one can deviate and still meet the requirement of the claim, and so a skilled artisan would not reasonably appreciate the metes and bound of what is encompassed by the claims. For the purposes of examination “configured to” will be interpreted as “capable of”.
Instant claim 19 is indefinite because it does not recite a transitional phrase and otherwise does not indicate if the list of polymers is recited with open or closed claim language. For the purposes of examination the claim will be interpreted as having opening claim language because claim 19 depends on claim 1 and claim 1 recites open claim language. “The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended” MPEP 2111.03 I.
Regarding claim 19, the phrase "such as", and limitations in parentheses, render the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112 – Improper Dependent Form
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 requires the therapeutic tape to be a food-grade silicone polymer. However, such a polymer would destroy the dissolvable nature of the therapeutic tape required by instant claim 1 because the food grade silicone polymer material of the instant application is not dissolvable. This notion is supported by the instant specification which discloses food grade silicone for an “everlasting” chew at page 9 lines 1-10 and for a tape which is “attached to brackets of braces initially in the first weeks of treatments where most uncomfortable soreness develops” (emphasis added) at page 12, lines 24-26. Furthermore, the specification does not disclose examples or embodiments of a dissolvable food grade silicone and does not teach a dissolvable food grade silicone material. In fact, food grade silicone is notably absent from Applicant’s list of dissolvable polymers on pages 19 and 24.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) Claim(s) 1, 6, 9, 14-16 and 20 is/are 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 (i.e., for application to body parts; instant claim 20) to deliver a breath freshening agent or substance for relief of sore throat (i.e., ingredient to improve health of user according to instant claim 9) [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], conforms smoothly to the oral cavity (i.e., mold around part) [col. 6, lines 66-67] and are very flexible [col. 8, line 3]. 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 polymer having at least an outer layer), a middle substance-containing (active containing) water soluble layer (i.e., second layer with at least one ingredient to improve health) and an adhesive layer which adheres to the mucosal surface (i.e., an inner surface that adheres to an underlying part comprising a third layer; instant claim 6) [col. 16, lines 52-57 and figure 2].
The prior art anticipates instant claims 1, 9 and 20 because upon reading Biegajski a skilled artisan would have at once envisaged a dissolvable flexible member able to mold around a part, wherein the member includes a dissolvable polymer having at least an outer layer, a second layer with at least an ingredient for improving the health of the user (breath freshener or pain reliever), and an inner surface comprising a third layer that adheres to an underlying surface. The prior art film is activated by contact with fluids because the film dissolves and the active agent elutes off by contact with fluids (i.e., instant claim 14). Wherein the polymer is dissolvable by contact with fluids (i.e., instant claim 15). Since the prior art composition contains substantially the same components, i.e., dissolvable multilayer films comprising dissolvable polymers, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as being applicable to a wound (instant claim 16).
2) Claim(s) 1, 5, 7, 9, 14-16 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Singh et al. (US 8,206,738 B2, date of patent 06/26/2012).
Singha relates to a hydrogel composition with an erodible backing member oral dressing [title & abstract]. In a specific example Singha discloses a melt extruded film comprising (see col. 27, lines 35-60; tables reproduced below):
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124
400
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195
996
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Wherein “[t]he Eudragit L 100-55 is added to the extruder first, followed by PVP and PEG, at a temperature of 100 to 150° C. The composition is extruded to a thickness of 0.35 mm between a polyethylene terephthalate release liner and an erodible backing member made of Eudragit S100 with appropriate plasticizer if needed. Hydrogen peroxide solution was added to the extruded film” [col. 27, lines 60-67].
According to Singha “Eudragit S-100 is insoluble at pH below 5.5, but unlike Eudragit L30D-55, is poorly soluble in aqueous fluids having a pH in the range of 5.5 to 7.0. This copolymer is soluble at pH 7.0 and above” (i.e., Eudragit S100 is a dissolvable polymer) [col. 11, lines 7-12].
The prior art anticipates instant claim 1 because it discloses a tape (film) for intraoral use comprising a dissolvable member comprising an dissolvable polymer outer layer (Eudragit S-100) and a second layer comprising an ingredient to improve the health of a user (hydrogen peroxide; whitening agent instant claim 9) and an inner adhesive surface. Wherein the film comprises a release layer (claim 5). The prior art film is activated by contact with fluids because the film dissolves by contact with fluids (i.e., instant claims 14 and 15). Wherein the composition is for application to the body (instant claim 20). Since the prior art composition contains substantially the same components, i.e., dissolvable multilayer films comprising dissolvable polymers, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as being flexible and capable of molding to a part, any layer capable of comprising additional ingredients for improving health (instant claim 7) and applicable to a wound (instant claim 16).
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.
1) Claim(s) 1-3, 5-9, 12, an 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, date of patent 12/23/1997).
In addition to, or in alternative to, the anticipation rejection set forth above, the claims would have also been obvious over Biegajski.
Biegajski relates to “devices for administering a substance over an extended time for relief of sore throat or cough, or for administering a breath freshening agent, particularly a mint odorant, include a water soluble polymer film layer containing the active ingredient, and a water soluble pressure sensitive mucoadhesive layer” (i.e., ingredients of instant claim 9) that “may conveniently be provided in dry film form” (i.e., tape) [abstract]. “Preferred water-soluble pressure-sensitive adhesive films according to the invention 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” (i.e., conform around a part) [col. 8, lines 1-5]. In Example 4 at column 19, Biegajski discloses:
“A multilayer device was made by first co-dissolving poly(vinylpropylene) ("PVP") (K90), glycerine, methylene blue and IPA in the following proportions […] The solution was coated onto a polyester release liner […] The resulting dry film constituted the active layer material. A second film was prepared by pressing HPCEF [hydroxypropylcellulose] powder to a thickness of about 4 mils, using the heated Carver press.
The PVP/glycerin/methylene blue film and the HPCEF film were then arranged in alternating fashion to produce a laminate of six layers, three containing and three not containing the substance to be delivered. The PVP/glycerin/methylene blue layers served as an adhesive to bond the laminate composite, and served as a reservoir for the substance (methylene blue, in this illustrative example) to be released from each layer as it dissolved.” [col. 19, lines 5-27].
Example 4 of Biegajski does not anticipate the instant claims because it does not disclose that the 6-layered film is flexible and does not explicitly disclose an ingredient for improving the health of a user.
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).
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 tape comprising a dissolvable, flexible member capable of molding around a part. Wherein the member includes a dissolvable polymer having an outer layer, a second layer with at least an ingredient to improve the health of the user (breath freshener) and an inner surface comprising a third layer (adhesive layer) that adheres to an underlying part (instant claims 1, 6 and 9). Wherein the polymer of the outer layer is neutral and a polysaccharide (i.e., hydroxypropyl cellulose1; instant claims 2 and 19). Wherein the member comprises a removable release liner coupled to the inner adhesive surface (instant claim 5). The prior art film is activated by contact with fluids because the film dissolves and the active agent elutes off by contact with fluids (i.e., instant claim 14). Wherein the polymer is dissolvable by contact with fluids (i.e., instant claim 15). Since the prior art composition contains substantially the same components, i.e., dissolvable multilayer films comprising dissolvable polymers, in the same relative proportions as instantly claimed, it would be expected to inherently possess the same chemical and physical properties, such as being applicable to a wound (instant claim 16) and applicable to body parts (instant claim 20).
Regarding instant claim 3, 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 7, Biegajski discloses that “Hydroxypropyl cellulose (HPC) can be a particularly suitable polymer for construction of the active-containing layer” [col. 21, lines 48-50] and that “HPC blends well with a variety of active substances” [col. 21, lines 58-59]. Therefore, a skilled artisan would have expected the HPC layers of the film in Biegajski‘s Example 4 to be capable of comprising additional ingredients for improving health. As such, the film of Example 4 reads on the instantly claimed film “wherein any of the layers of the member may have additional ingredients for improving health.”
Regarding instant claim 8, Biegajski 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” (i.e., conformable) [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].
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). Namely 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 flexibility desired by Biegajski with the film of Example 4. As a result, the film would have 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 of Example 4 to elongate (i.e., stretch).
Biegajski discloses “the product can be cut to a shape appropriate to the particular application, and the release liners can be peeled away just prior to use” (i.e., pre-cut) [col. 34, lines 21-23], as per instant claim 12.
Regarding instant claim 17, Biegajski’s discloses 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 obvious to one of ordinary skill in the art, before the effective filling date of the claimed invention, to have provided films of Biegajski capable of withstanding chewing in the original form for a period of time ranging from minutes to hours. One would have been motivated to do so to ensure the film delivers medication for 4 hours while applied to the teeth. One would have had an expectation of success because Biegajski teaches the film may be applied to the teeth for 4 hours. 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 provided the films taught by Biegajski, as discussed above, wherein the films are able to withstand chewing in the original form for a period of time ranging from minutes to hours.
Regarding instant claim 18, 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. Cutting the film to closely adhere to the teeth to protect the mouth 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) Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, date of patent 12/23/1997) as applied to claims 1-3, 5-9, 12, an 14-20 above, and further in view of Rajaiah et al. (WO 2007/056612 A2, publication date 05/18/2007).
Biegajski, which is taught above, differs from instant claim 4 insofar as it does not explicitly discloses a dissolution rate of 72 hours. As discussed in the anticipation rejection above, 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], conforms smoothly to the oral cavity (i.e., mold around part) [col. 6, lines 66-67] and are very flexible [col. 8, line 3]. 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 polymer having at least an outer layer), a middle substance-containing (active containing) water soluble layer (i.e., second layer with at least one ingredient to improve health) and an adhesive layer which adheres to the mucosal surface (i.e., an inner surface that adheres to an underlying part comprising a third layer) [col. 16, lines 52-57 and figure 2]. Biegajski further discloses the “film[s] can be used as a denture adhesive, that can adhere to oral mucosal surfaces and to dental prosthesis for an extended period, typically of more than about 5 hours. The film can be used as part of a system for delivery of substances through the oral mucosa (as a buccal transmucosal patch), or for delivery of substances into the oral cavity itself” [col. 8, lines 5-11].
Rajaiah “relates to a denture adhesive article comprising: a) a safe and effective adhesive amount of a water soluble denture adhesive component; b) a safe and effective amount of a component selected from the group consisting of a water soluble plasticizer, a water soluble carrier, and mixtures thereof; wherein the article is bioerodible” [abstract] and wherein the article may be a film [p. 16, lines 6-7]. According to Rajaiah, a suitable amount of time for the bioerodible article to erode in is 1-3 day [p. 4, lines 10-13].
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 1-3 day erosion of Rajaiah with the denture adhesive films disclosed by Biegajski. One would have been motivated to make this combination because Rajaiah discloses 1-3 day is a suitable amount of time for water soluble denture adhesive films to erode. One would have had an expectation of success because Biegajski desires the water soluble denture adhesive films disclosed therein to dissolve over more than 5 hours. 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.
Furthermore, 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). In the present case, the instantly claimed 72 hour period of time overlaps with the 1-3 day range taught by the prior art and so a prima facie case of obviousness exists.
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 a dissolvable flexible member able to mold around a part, wherein the member includes a dissolvable polymer having at least an outer layer, a second layer with at least an ingredient for improving the health of the user, e.g., breath freshener, and an inner surface that adheres to an underlying surface. Wherein the film dissolves over a 72-hour time period.
3) Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, date of patent 12/23/1997) as applied to claims 1-3, 5-9, 12, an 14-20 above, and further in view of Singh et al. (US 8,206,738 B2, date of patent 06/26/2012).
Biegajski, which is taught above, differs from the instant claims insofar as it does not disclose that the final films are clear, transparent or opaque. Biegajski discloses translucent layers, specifically that layers of Hydroxy propyl cellulose (“HPC"), poly(vinyl pyrrolidone) (PVP) and glycerin are translucent [col. 14, lines 32-37].
Singha relates to a hydrogel composition with an erodible backing member oral dressing [title & abstract] which may be used to deliver breath freshener actives [col. 15, line 30]. According to Singha, the compositions may vary in appearance from clear, transparent to translucent to opaque” [col. 15, lines 1-3].
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 films of Biegajski to be clear, translucent or opaque, as disclosed by Singha because Singha discloses clear, transparent or opaque are suitable appearances for dissolvable oral films used to deliver breath freshening active agents. One would have had an expectation of success because, Biegajski discloses translucent layers. 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 oral films taught by Biegajski, as discussed above, to be clear, translucent or opaque.
4) Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Biegajski et al. (US 5700478, date of patent 12/23/1997) as applied to claims 1-3, 5-9, 12, an 14-20 above, and further in view of Allred et al. (US20160367348, publication date 12/22/2016).
Biegajski, which is taught above, differs from instant claim 11 insofar as it does not teach the product 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” [0010]. One “exemplary packaging system [is] for use in maintain the stability of an oral treatment composition” [0061], such as an adhesive [0071]. 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” [0096].
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.
1) Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 11, 13-18, and 21-28 of copending Application No. 17/581,825 (US20220226228A1). Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a flexible stretchable member capable of conforming to a part and comprising “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 teeth, soft tissues, and/or braces” (i.e., underlying surface) [claim 1]. Wherein the strip is dissolvable over a period of hours or minutes [claim 24].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
2) Claim 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 and 21-29 of copending Application No. 18/607,542 (US20240216108A1) in view of Singha et al. (US 8,206,738 B2, date of patent 06/26/2012).
The copending claims disclose “a member of flexible material that includes at least one ingredient to improve oral care during treatment with braces or aligners, said material comprising a single layer of a hydrogel material; wherein the flexible member has adhesive properties to permit application over the teeth, braces, gums, soft tissues […] and to remain in place for about 30 minutes or more, 45 minutes or more, or 60 minutes or more” [claim 1]. Suitable polymers include “polyacrylates, polyacrylate copolymers, polyvinyl alcohols, polyvinyl pyrrolidones, polyalkylethers, polysaccharides, carbohydrates” [claim 7].
The copending claims do not disclose multiple layers or that the member is dissolvable.
Singha relates to a hydrogel composition with an erodible backing member oral dressing [title & abstract]. Singha discloses “The erodible backing member is comprised of a polymer composition that erodes in a moist environment at a slower rate than the hydrogel and is substantially non-tacky” [col. 21, lines 20-23]. “In one embodiment, the hydrogel erodes in about 1 second to 24 hours after placement in a moist environment” [col. 21, lines 30-31].
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 erodible backing member of Singha and the dissolvability of Singha with the member disclosed by the copending claims. One would have been motivated to make this combination because Singha discloses it is suitable to form oral films as erodible oral films. One would have been motivated to combine the backing layer to ensure the film remain in place as desired by the copending claims. One would have had an expectation of success because Singha disclosed the erodible backing layer for use with a hydrogel layer. 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.
This is a provisional nonstatutory double patenting rejection.
Technological Background
The prior art made of record is considered pertinent to applicant's disclosure. Mezdour et al., Food Hydrocolloids, 2007, v. 21, p. 776-781. Mezdour is pertinent for teaching hydroxypropyl cellulose (HPC) is a neutral polysaccharide.
Conclusion
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/C.T.W./ Examiner, Art Unit 1612
/WALTER E WEBB/ Primary Examiner, Art Unit 1612
1 Mezdour et al., Food Hydrocolloids, 2007, v. 21, p. 776-781.
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