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 .
Reopening of Prosecution After Appeal Brief
In view of the Appeal Brief filed on 1/28/2026, PROSECUTION IS HEREBY REOPENED. A new ground of rejection is set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
Response to Amendment
The Appeal Brief filed 12/30/2025 has been entered. Applicant’s arguments are in response to in the Final Office Action mailed 05/30/2025. Applicant’s claims under examination in this Office Action, are for the claim set that was filed 04/28/2025, as also found in the pg 11-14 Appendix of the Appeal Brief (i.e., the claim set filed 09/30/2025 was denied entry due to introduction of a scope changing amendment after the Final Office Action). Furthermore, the Appeal Brief mainly focuses on the proposed allowability of instant claim 6.
The arguments against the motivation to combine Solomonidou within the Prior Art on record are persuasive (see ‘response to arguments’ below for explanation). Therefore, the 103 rejection has been withdrawn (by removing Solomonidou’s teaching of the neutralization of free carboxyl groups of a polymer in a film formulation).
However, the withdrawal of the 103 rejection (caused by Applicant’s arguments against Solomonidou) is modified by teachings of Zhang (i.e., Zhang is on record from the previous Final Office Action) with additional references that provided a better representation of the Prior Art. Herein, the new grounds of rejection are made primarily on the basis of previously unconsidered exemplary species of Zhang such as sodium alginate (Na alginate) and sodium carboxymethyl cellulose (NaCMC) (i.e., they are taught as exemplary polymeric species suitable for incorporation into the dissolvable backing layer of the multi-layer films, in the same paragraph that polyacrylic acid is taught [0037]). Thus, Solomonidou is no longer required to teach the neutralization of the polymers containing free carboxyl groups (such as polyacrylic acid), as applied to drug-delivery film formulations. Additionally, new evidentiary references of Frei-Rutishauser and Aktar are incorporated to provide the structures of Na alginate and NaCMC (i.e., they represent polymers containing neutralized carboxyl groups), and overall editing has been conducted for readability and improved fit of the newly incorporated references.
Furthermore, the reference Chan (US20060198873A1; where PGPub is a family member of JP2006528636A from the new IDS filed 05/29/2025, as #9 on the Foreign Patent Document List) is incorporated into the new grounds of rejection. The most recent IDS (filed 05/29/2025) was not previously considered in the Final Office Action (mailed 5/30/2025), because it had not been filed in a timely manner compared to the Final Office Action mail date. Thus, the most recent IDS contained a reference (specifically, Chan) relevant to patentability of the instant Application. Finally, Manhar (Journal of Applied Pharmaceutical Science, 2013) have been incorporated to more precisely address Applicant’s issues with the rejection, as a whole.
Thus, this Office Action constitutes a second Non-Final Office Action. Furthermore, “there is nothing unusual, certainly, about an examiner changing his viewpoint as to the patentability of claims as the prosecution of a case progresses, and so long as the rules of Patent Office practice are duly complied with an applicant has no legal ground for complaint because of such change in view. The life of a patent solicitor has always been a hard one. In re Ruschig, 154 USPQ 118, 120-21 (CCPA 1967).” In this case, the Examiner had not previously recognized specific chemical structures of sodium alginate (Na alginate) and sodium carboxymethyl cellulose (NaCMC), as evidenced by Frei-Rutishauser and Aktar, which are identified by Zhang as components of the backing layer [0037], and therefore, did not properly consider their contribution within the Prior Art.
The Examiner further acknowledges the following:
Claims 1-19 are pending.
Claims 1-19 are presented for examination and rejected as set forth below.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3, 5, 8-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 20040224007 A1; cited on the IDS on 12/21/2023), as evidenced by Frei-Rutishauser (BioProcess International, 2016) and Aktar (Polymers, 2014).
Independent claim 1 (from which all other claims depend from) is directed to a multi-layer oral thin film comprising a matrix layer, which contains at least one polymer and at least one pharmaceutically active agent, and at least one backing layer, wherein the at least one backing layer comprises at least one polymer containing free carboxyl groups, wherein 10 to 100% of the free carboxyl groups of the at least one polymer comprising free carboxyl groups are present in a neutralized form as a salt. The term “free carboxyl groups” is understood to mean a free acid of a carboxyl group (or carboxylic acid group).
Zhang teaches a multi-layer drug delivery device comprising a water-dissolvable backing layer (abstract, Fig. 1).
Regarding claims 1, 3, 5, and 14-15: Zhang teaches a buccal patch (defined as a flexible film [0006] and reads on oral) that comprises several layers (Zhang – claims 1 and 18). There is an active layer that comprises a drug or active agent and a matrix material [0066]. The matrix material can be a polymer [0069]. There is also a backing layer comprising a film (Zhang – claim 14) that can be made of polyacrylic acid (a non-limiting example), which is defined by Zhang as a hydrophilic polymer [0037]. Zhang teaches incorporation of one or more “hydrophilic polymer that have the property of being dissolvable in saliva or moisture of an oral cavity” into the backing layer [0037].
Furthermore, Zhang teaches sodium carboxymethyl cellulose (NaCMC) and sodium alginate (Na alginate) (i.e., Na alginate is notably distinguished as a preferred species in [0037]), as exemplary polymeric species, as suitable for incorporation into the dissolvable backing layer of the multi-layer films [0037].
As evidenced by Frei-Rutishauser, NaCMC is a chemical polymer that contains carboxylic acids which are neutralized by sodium (pg 1; see below for reproduced figure).
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As evidenced by Aktar, sodium alginate is a chemical polymer that contains carboxylic acids which are neutralized by sodium (pg 1351, Figure 1).
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Thus, the sodium alginate and NaCMC, as taught by Zhang as suitable for the dissolvable backing layer [0037], are 100% deprotonated as depicted in the images above (meeting the 100% neutralization limitation of instant claim 1).
Furthermore, the pre-neutralization of polymers like polyacrylic acid is also obvious because Zhang provides a non-limiting list of compounds to represent hydrophilic polymers (including polymers containing free carboxyl groups such as polyacrylic acid [0037]) suitable for incorporation into the backing layer, that can be in acidic (e.g., polyacrylic acid) or in neutralized form (e.g., Na alginate or NaCMC) [0037].
Regarding % neutralization range of instant claim 1, note that Zhang’s teaching of polyacrylic acid infers 0% neutralization of free carboxyl groups and Zhang’s teaching of Na alginate or NaCMC infers 100% neutralization of free carboxyl groups (see images above). Furthermore, mixtures of free acid polymers and neutralized polymers, as taught by Zhang with “one or more hydrophilic polymers” [0037], renders the entirety of the instant range of 10-100% obvious. Note that "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003) (see 2144.05(I)).
The hydrophilic polymer ranges from 10 to 80 wt% [0042] of the hydrophilic region of the backing layer, which overlaps with the instant range of 10-99 wt% of instant claim 3. With regard to the numerical range, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”).
Furthermore, Zhang teaches the time in which the hydrophilic region or component will dissolve when exposed to moisture (e.g., saliva) depends on a number of factors, including identity and concentrations of the various components [0041].
Zhang also teaches a process method in developing a gel composition (which can be a colloid solution or suspension, so reads on solution or suspension) for the active layer (comprising the drug interferon), pipetting the gel onto a disk (reads on spreading out), and drying overnight [0091]. Zhang teaches a method in developing a gel composition (reads on suspension or solution) for the backing layer, casting the gel composition into a plastic mold (reads on spreading out), and allowing it to dry. The active layer is then pressed gently on top of the combined adhesive and backing layer, joining together the active and backing layers to form the combined multi-layer patch [0094]. Figure 2 [0022] is further exemplified, in which the active layer is directly joined onto the backing layer. Finally, Zhang demonstrates a method for the delivery of interferon as the active agent by applying the oral transmucosal delivery patch to a dog cheek in an animal study [0012, 0088, 0095-0096].
Regarding claim 8: Zhang teaches a plasticizer in the backing layer (Zhang - claim 8, [0038]).
Regarding claims 9-10: Zhang teaches the active layer contains a matrix comprising a polymer such as alginic acid, its salts and derivatives, celluloses, cellulose ethers, their salts and derivatives, starches, carrageenan, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, polyvinyl pyrrolidone, acacia, and polyacrylic acids [0069].
Regarding claim 11: Zhang teaches examples of actives such as fentanyl, codeine, sufentanil, lofentanil, carfentanil, alfentunil, morphine, other opiates, sumatriptan, other triptans, interferons, heparin, proteins, peptides, barbiturates, analgesics, anesthetics, anxiolytics, sedatives, anti-depressants, cannabinoids, anticoagulants, antibiotics, antihistamines, blood pressure modulators, anti-cholesterol drugs, etc. [0067].
Regarding claim 12: Zhang teaches auxiliary substances in the active layer such as enhancers [0068] and flavorants/sweeteners [0071] and in the backing layer such as flavors, sweeteners, coloring agents, preservatives, surfactants, plasticizers, emulsifiers, etc. [0038].
In summary, Zhang teaches a multi-layer oral film comprising a backing layer and an active layer that comprise specific components. Zhang further teaches a method of making the multi-layer oral film and method of administering the multi-layer oral film for drug delivery.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 20040224007 A1; cited on the IDS on 12/21/2023), as evidenced by Frei-Rutishauser (BioProcess International, 2016) and Aktar (Polymers, 2014), as applied to claims 1, 3, 5, 8-12, and 14-15 above, and in further view of Chan (US20060198873A1; where PGPub is a family member of JP2006528636A from the new IDS filed 05/29/2025, as #9 on the Foreign Patent Document List), and Manhar (Journal of Applied Pharmaceutical Science, 2013), as evidenced by Thakral (Expert Opinion on Drug Delivery, 2013).
As discussed above, Zhang teaches a transmucosal delivery device with a water-dissolvable backing layer and an active layer with a drug and polymeric matrix, in which the free carboxyl groups of the hydrophilic polymer of the backing layer can be neutralized. Zhang also teaches a general process method assembling the multi-layer oral thin films (as found in instant claim 13). However, Zhang does not explicitly teach the pH of the film layer of pH 3.5-7 (instant claim 2; i.e., based on the ingredients recited by Zhang, one would expect a pH range that overlaps with the instant range), polymers with free carboxyl groups of 10-40 wt% (instant claim 4), a (meth)acrylic/acid/ethyl acrylate copolymer (instant claim 6), and the neutralization of the free carboxyl groups in the backing layer with sodium hydroxide (NaOH), in relation to the method or composition (instant claims 7, 13, and 16).
Chan teaches orally dissolving films that contain pre-neutralized Eudragit type films such as poly(ethylacrylate-methacrylic acid) copolymer (reads on claim 6) (Chan – claim 14, [0037, 0050]), that are neutralized with alkaline neutralizing agents such as sodium hydroxide (reads on claims 7, 13, and 16) (Chan – claim 16), where the disclosed copolymer exhibits pH sensitive solubility [0029]. Thus, poly(ethylacrylate-methacrylic acid) copolymers are demonstrated by Chan as suitable ingredients in dissolvable film formulations and meet Zhang’s definition for an ingredient of the backing layer (i.e., Zhang teaches incorporation of one or more “hydrophilic polymer that have the property of being dissolvable in saliva or moisture of an oral cavity” into the backing layer” with polyacrylic acid, Na alginate, and NaCMC, as non-limiting examples [0037]). By example, Chan teaches neutralization of Eudragit L100-55 in a demonstration [0050]. As evidenced by Thakral (see pg 134, table 1), the structure of Eudragit L100-55 (and Eudragit L100) has a 1:1 acid to ester ratio (i.e., within the “ethyl acrylate-methacrylic acid” subunit) (pg 134, table 1) (i.e., reads on instant claim 4 for “the content of free carboxylic groups in the polymer comprising free carboxyl groups is 10 to 40 wt%”, because the free carboxyl group molecular weight is 46 g/mol, within the larger “ethyl acrylate-methacrylic acid” subunit weighing 186.21 g/mol; thus, 46/186 = 24 wt%).
Manhar teaches oral film compositions comprising mixtures of Eudragit L100 (polymer with free carboxyl groups) and NaCMC (polymer with sodium neutralized carboxyl groups) to have pHs between 5.88-7.23 (see S4-S6 in Tables 1-3, pg 077) (reads on the instant pH range of 3.5 to 7 in claim 2, by overlap). The FFP:MP ratios of 5:3, 7:1, and 3:1 represent about 25% neutralization in the film layer. Drug release in S4-S6 is affected by the change in polymeric ingredient amounts (Fig 1, pg 078), whereby drug release rate is controlled by dissolution kinetics of the polymers (pg 078-079, ‘drug release study’).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate pre-neutralized Eudragit polymers (i.e., with certain carboxyl group content, formed by sodium hydroxide deprotonation, and specified with a certain pH), as described by Chan and Manhar, into Zhang’s backing layer, because Zhang teaches incorporation of hydrophilic polymers (i.e., including but not limited to polyacrylic acid, Na alginate, NaCMC, etc.) in the dissolvable backing layer, where the selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). Thus, poly(ethylacrylate-methacrylic acid) copolymers (including pre-neutralized forms) are demonstrated by Chan as suitable for dissolvable film formulation structures, and meet Zhang’s definition for an ingredient of the backing layer (i.e., Zhang teaches incorporation of one or more “hydrophilic polymer that have the property of being dissolvable in saliva or moisture of an oral cavity” into the backing layer with polyacrylic acid, Na alginate, and NaCMC, as non-limiting examples [0037]). Thus, the combined Prior Art teaches the obviousness of the instant claims, including claim 6 (as discussed in the Appeal Brief filed 12/30/2025).
Additionally, in terms of motivation, Chan teaches poly(ethylacrylate-methacrylic acid) copolymers (including pre-neutralized forms) exhibits pH sensitive solubility [0029]. Thus, a PHOSITA would be able to modulate the solubility property of the backing layer by including Chan’s copolymers into the backing layer, whereby Zhang teaches the time in which the hydrophilic region or component will dissolve when exposed to moisture (e.g., saliva) depends on a number of factors, including identity and concentrations of the various components [0041].
Claims 1, 3, 5, 8-12, 14-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 20040224007 A1; cited on the IDS on 12/21/2023), as evidenced by Frei-Rutishauser (BioProcess International, 2016) and Aktar (Polymers, 2014), as applied to claims 1, 3, 5, 8-12, and 14-15 above, and in further view of Tao (US20180289606A1).
As discussed above, Zhang teaches a transmucosal delivery device with a water-dissolvable backing layer and an active layer with a drug and polymeric matrix, in which the free carboxyl groups of the hydrophilic polymer of the backing layer can be neutralized. Zhang teaches plasticizers for use in the backing layer [0038]. However, the Zhang does not specifically teach triethyl citrate as the plasticizer (instant claim 17).
Tao teaches a multi-film delivery system intended for tooth whitening in the mouth (abstract). The orally dissolvable films (ODFs) can comprise poly(meth)acrylic acid (Tao – claim 2 and claim 8) and further comprise plasticizers such as triethyl citrate (Tao – claim 16) for the purpose of increasing the workability, spreadability, and flexibility of the ODF.
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the backing layer of the film taught by the Prior Art with a plasticizer such as triethyl citrate because triethyl citrate would increase the workability, spreadability, and flexibility of the backing layer.
Claims 1, 3, 5, 8-12, 14-15, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (US 20040224007 A1; cited on the IDS on 12/21/2023), as evidenced by Frei-Rutishauser (BioProcess International, 2016) and Aktar (Polymers, 2014), as applied to claims 1, 3, 5, 8-12, and 14-15 above, and in further view of Salama (US20140079740A1).
As discussed above, Zhang teaches a transmucosal delivery device with a water-dissolvable backing layer and an active layer with a drug and polymeric matrix, in which the free carboxyl groups of the hydrophilic polymer of the backing layer can be neutralized. Zhang teaches analgesics, anesthetics, anxiolytics, sedatives, anti-depressants, cannabinoids, anticoagulants, antibiotics, antihistamines, blood pressure modulators, anti-cholesterol drugs, etc. [0067]. However, the Zhang does not teach specifically the instant S-ketamine (claims 18-19).
Salama teaches S-ketamine, its salts and/or derivatives for oral transmucosal administration forms for the treatment of pain (abstract, title), including fast dissolving oral thin films [0001, 0162-0163]. Salama teaches ease of administration, improved compliance, and predictable systemic dosing of these formulations [0036-0037].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to use S-ketamine in the oral thin film drug taught above because S-ketamine oral thin films are known to be useful in the literature for treatment of pain in contrast to typical oral or intranasal administration [0028-0029], and the advantages of using S-ketamine for pain in a buccal delivery system (i.e., oral thin film) are described by Salama, including ease of administration, improved compliance, and predictable systemic dosing [0036-0037], which are also some advantages Zhang describes of buccal systems [0008, 0012]. Thus, a person skilled in the art would have thought to combine S-ketamine into the oral thin film formulation described in the prior art above.
Response to Arguments
Applicants arguments (i.e., “Appeal Brief Filed”), see pg 1-14, filed 12/30/2025, with respect to the 103 rejection of claims 1-19 under rejection have been fully considered and are persuasive (see below for further explanation). Therefore, the 103 rejection has been withdrawn (by removing Solomonidou’s teaching of the neutralization of the free carboxyl groups of a backing layer polymer).
However, a new ground of rejection is made on the basis of previously unconsidered polymeric species of the Zhang reference on record, that contain neutralized carboxyl groups (i.e., sodium alginate (Na alginate) and sodium carboxymethyl cellulose (NaCMC)), which are from the same section of Zhang that teaches the previously discussed polyacrylic acid, as a hydrophilic polymer useful for incorporation into a dissolvable backing layer [0037]) (see 103 above). The structures of Na alginate and NaCMC are evidenced by Frei-Rutishauser and Aktar. Thus, prosecution has been reopened.
Due to the application of a new ground of rejection in the 103, many arguments below are now moot, but will be responded to, if possible.
On pg 1-2, Applicant provides an introduction.
On pg 3 (and 9), Applicant argues that instant claim 6 is non-obvious, such that claim 6 is directed to a multi-layer oral thin film comprising a matrix layer which contains at least one polymer, at least one pharmaceutically active agent, and at least one backing layer, where the at least one backing layer comprises a (meth)acrylic acid/ethyl acrylate copolymer wherein 10 to 100% of the free carboxyl groups comprise free carboxyl groups present in a neutralized form as a salt. The Examiner directs Applicant to the new 103 rejection (see above), that demonstrates the obviousness of claim 6.
On pg 4, Applicant presents the background and context of the argument.
As a point of notice, it is noted that a general recognized theme of the arguments is that the references are treated piecemeal, which is per se unpersuasive. It is the combined teachings that define the art, where the combined Prior Art listed in the 103 rejection, provides a prima facie case of obviousness. The Examiner attempts to address the arguments outside of the piecemeal arguments presented. Further discussion is provided below.
On pg 4, Applicant argues that Zhang only teaches polyacrylic acid as one of over forty possible choices. Note that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985). Thus, Zhang provides a direct teaching of selecting polyacrylic acid as a non-limiting example of a “hydrophilic polymer that have the property of being dissolvable in saliva or moisture of an oral cavity” [0037].
Furthermore, with respect to the new 103 rejection above, Zhang teaches sodium carboxymethyl cellulose (NaCMC) and sodium alginate (i.e., notably distinguished as a preferred species in [0037]), also as exemplary polymeric species, as suitable for incorporation into the dissolvable backing layer of the multi-layer films [0037], which demonstrates the obviousness of dissolvable backing layers comprising polymers with neutralized carboxyl groups by Zhang.
On pg 4, Applicant argues that Zhang does not teach selection of (meth)acrylic acid/ethyl acrylate copolymer. As discussed before, this is a piecemeal argument that is per se unpersuasive. Furthermore, the addition of Chan and Manhar in the new ground of rejection (see 103 above) sufficiently teach the obviousness of (meth)acrylic acid/ethyl acrylate copolymers (including pre-neutralized forms) in film structures intended for drug delivery formulations. Thus, the above rationale of the combined Prior Art demonstrates the use of (meth)acrylic acid/ethyl acrylate copolymers (including pre-neutralized versions) as a backing layer in drug devices as obvious.
On page 4, Applicant argues that Zhang does not teach that selection of different materials for backing layers (including neutralized polymers) can be used to adjust dissolution time. First, it is not necessary that the Prior Art teach the same motivation as Applicant: In an obviousness analysis, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
However, even with this guidance, Zhang teaches directly that “the time in which the hydrophilic region or component will dissolve when exposed to moisture (e.g., saliva) depends on a number of factors. These include the identity and concentrations of the various components within the hydrophilic region, the components within the non-hydrophilic region discussed more fully below, as well as their size, the thickness of the overall backing layer, the amount of moisture to which the backing layer is exposed, and the existence of agitation, movement or other external forces (e.g., tongue movements) that might accelerate the breakdown or dissolution of the backing layer” [0041]. Thus, Zhang precisely teaches that “the identity and concentrations of various components” within the backing layer affects dissolution time of the backing layer [0041].
Furthermore, in consideration of all Prior Art on record (i.e., where it is the combined teachings that are relevant), Chan teaches orally dissolving films that contain pre-neutralized Eudragit type films such as poly(ethylacrylate-methacrylic acid) copolymer (Chan – claim 14, [0050]), where the disclosed copolymer exhibits pH sensitive solubility [0029]. Also, Manhar teaches oral film compositions comprising mixtures of Eudragit L100 (polymer with free carboxyl groups) and NaCMC (polymer with sodium neutralized carboxyl groups), where the drug release in S4-S6 is affected by the change in polymeric ingredient amounts (Fig 1, pg 078), whereby drug release rate is controlled by dissolution kinetics of the polymers (pg 078-079, ‘drug release study’). Thus, the combined Prior Art readily teaches that selection of different materials for backing layers (including neutralized polymers) that are used to adjust dissolution time.
On page 4, Applicant argues that Zhang does not teach a copolymer in a neutralized form as a salt. As discussed as the primary reason for this second non-final action, a revisitation of Zhang demonstrates that Zhang clearly teaches a copolymer in a neutralized form as a salt (see 103 rejection for discussion of NaCMC and Na alginate, and also the rationale for neutralizing polyacrylic acid as taught by Zhang [0037]. Specifically, Zhang recites two polysaccharide polymers (i.e., sodium carboxymethyl cellulose (NaCMC) and Na alginate) for the backing layer (in addition to polyacrylic acid), where the polysaccharide polymers are sodium salts of free carboxylic acids [0037]. Framed against the instant invention, this also demonstrates the breadth that was intended by Zhang to include hydrophilic polymers such as polyacrylic acid, that are also useful in their neutralized sodium salt form (as demonstrated by examples of NaCMC and Na alginate) [0037]. Furthermore, Zhang teaches the time in which the hydrophilic region or component will dissolve when exposed to moisture (e.g., saliva) depends on a number of factors, including identity and concentrations of the various components [0041].
On pg 5, Applicant argues against Solomonidou, suggesting Solomonidou does not teach neutralization to modify dissolution time, improve mouthfeel or residue of backing layer. This is argument is moot because Solomonidou is no longer relied upon in the rejection, and this argument is addressed in other sections of this response and the 103 rejection (i.e., Zhang, Chan, and Manhar teach selection of acid and/or pre-neutralized polymers affect dissolution time of a film layer in an oral film composition).
On pg 5, Applicant argues against incorporation of 3V reference, where the 3V references does not teach an improved backing layer for an oral thin film. This is argument is moot because 3V is no longer relied upon in the rejection, and this argument is addressed in other sections of this response and the 103 rejection (i.e., Manhar now teaches the obviousness of pH of oral film compositions).
On pg 5-6, Applicant argues that Thakral does not teach Eudragit as a backing layer. As discussed before, this is a piecemeal argument that is per se unpersuasive. References need not teach all elements. All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). However, in order to provide a more specifically address Applicant’s invention, Chan and Manhar are incorporated to teach different Eudragit species, including pre-neutralized versions for oral film formulations (i.e., whereby Thakral now provides evidentiary information on the structural nature of the proprietary names for the polymers discussed by Chan and Manhar).
On pg 6-7, with respect to “obvious to try”, the Examiner does not invoke this specific KSR-rationale. This is argument is moot because Thakral is no longer relied upon in the rejection (i.e., as motivation), and this argument is addressed in other sections of this response and the 103 rejection (i.e., the selection of Eudragit from the teachings of Chan and/or Manhar is obvious, when Zhang teaches incorporation of one or more “hydrophilic polymer that have the property of being dissolvable in saliva or moisture of an oral cavity” into the backing layer [0037] and Chan and Manhar teach pre-neutralized Eudragit polymers that are dissolvable polymers in the oral cavity). Further note that semantic arguments based on “could” vs “would” are generally not persuasive. Furthermore,
On pg 7, Applicant returns to the selection of polyacrylic acid in Zhang among hundreds of dissolvable backing film materials, which has been addressed above. Furthermore, Zhang teaches the time in which the hydrophilic region or component will dissolve when exposed to moisture (e.g., saliva) depends on a number of factors, including identity and concentrations of the various components [0041].
On pg 7, Applicant suggests that the Examiner has selected Eudragit merely because it exists. Note the new ground of rejection, that demonstrates incorporation of various Eudragit species (including pre-neutralized versions disclosed by Chan and Manhar) in oral drug film formulations.
On pg 7-8, Applicant states that neutralization of polyacrylic acid into a neutralized form is not a modification a PHOSITA would pursue because Solomonidou teaches the resulting effect to be improved mucoadhesive adhesion. With respect to arguments regarding the rationale to incorporate Solomonidou the in the previous Final Office Action, the Examiner finds Applicant’s arguments persuasive. The Examiner agrees with line of argumentation for the mucosal irritation of the small intestine (as taught by Solomonidou) versus irritation of the oral cavity by films (which was the Examiner’s proposed explanation for joining Zhang with Solomonidou) is persuasive.
However, the Examiner points to the new ground of rejection, regarding Zhang, that demonstrates neutralization of polymers containing free carboxylic acids as obvious (see 103 rejection above). A revisitation of Zhang demonstrates that Zhang clearly teaches a copolymer in a neutralized form as a salt (see 103 rejection for discussion of NaCMC and Na alginate chemical structures, and also the rationale for neutralizing polyacrylic acid as taught by Zhang [0037]). Specifically, Zhang recites two polysaccharide polymers (i.e., sodium carboxymethyl cellulose (NaCMC) and Na alginate) for the backing layer (in addition to polyacrylic acid), where the polymers contain neutralized carboxyl groups (as required by instant claim 1) [0037]. Framed against the instant invention, this also demonstrates the breadth that was intended by Zhang to include hydrophilic polymers such as polyacrylic acid, that are also useful in their neutralized sodium salt form (as demonstrated by examples of NaCMC and Na alginate) [0037]. Furthermore, Zhang teaches the time in which the hydrophilic region or component will dissolve when exposed to moisture (e.g., saliva) depends on a number of factors, including identity and concentrations of the various components [0041].
On pg 8-9, Applicant argues that the instant invention is for oral application and provides benefits of dissolving without residue and good mouthfeel. Zhang already teaches these beneficial effects, as expected benefits of dissolvable backing layers (e.g., for dissolvable backings “this eliminates the need to remove the patch”, which eliminates residue and is expected to improve mouthfeel) [0009-0010].
On pg 9-10, Applicant argues that instant claim 6 is non-obvious and concludes. However, the Examiner has furnished new grounds of rejection (as provided in the 103 rejection above) that demonstrates obviousness of the instant claim set. The instant claim set is rejected on the basis of the new grounds of rejection by this second Non-Final Action, and thus reopening prosecution.
On pg 11-14, Applicant recites the claims assessed at the time of the final rejection (filed 4/28/2025), which are the examined claim set in this current Office Action.
Correspondence
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/R.P./Examiner, Art Unit 1614 6/29/2026
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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