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 .
Status of the Claims
Claims 1-6, 9-14, 16, 18-19, and 21 are pending and under current examination. Claims 7, 8, 15, 17, and 20 are cancelled.
Withdrawn Claim Rejections
All rejections pertaining to claims 7, 8, 17, and 20 are moot because the claims are cancelled in the amendments to the claims filed 12/5/2025.
All rejections under 35 U.S.C. 102 are withdrawn in view of the amendments to the claims filed 12/5/2025.
All rejections not reiterated have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s amendments to the claims filed 12/5/2025 have necessitated the new grounds of rejection.
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.
Claims 1-6, 9, 10, 12-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (U.S. Application No. 2005/0136096, publication date: 6/23/2005, cited in the IDS filed 7/25/2023, of record) in view of Salehi et. al. (Progress in Biomaterials, pg. 175-187, publication year: 2017, of record), as evidenced by Singh et. al. (Carbohydrate Polymers, pg. 190-207, publication year: 2015, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 1 and 14, Davidson discloses a method, for preparing a thin film, Example XII, wherein xanthan gum, locust bean gum, carrageenan and pullulan are mixed and hydrated in hot purified water to form a gel. The gel is stored in a refrigerator overnight to form a film layer [0065]. Chlorhexidine is combined with carboxymethylcellulose powder, modified food starch, carrageenan, sucralose, talc, catnip and a lipid to produce a powder matrix [0083]. The powder matrix is applied to the upper exposed surface of the film layer via static spray gun. The powder matrix layer and film layer together comprise a medicant composition [0084]. The medicant composition is cured using any desired heat treatment process [0086]. The Examiner considers the phrase “cured using any desired heat treatment process” to read on the “forming a composite between the polymer film and the powder” limitation of the instant claim. Davidson also teaches that auxiliary adhesion compositions that adhere to the oral mucosa may be included in the oral dissolving film and that all examples of composition provided are given without limiting the use or inclusion of other comparable functionally equivalent compositions even though such comparable or functionally equivalent compositions are not listed [0031].
Regarding claim 2, Davidson teaches that the film layer is dried at 200oF and that the lipid preferably has a softening point or melting temperature of about 200oF so that the temperature at which the film layer is dried is the ideal softening point for the lipid. [0085].
Regarding claim 3, Davidson does not disclose the residual moisture properties as recited in claim 3. However, the invention as claimed is not structurally distinguishable from the disclosure of Davidson and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Regarding claim 4, Davidson discloses that the composition applied to the polymer film contains carboxymethylcellulose powder and carrageenan [0083].
Regarding claim 5, Davidson discloses that pullulan is present as a polymer in the film [0065]. Singh teaches that pullulan is a water soluble exo-polysaccharide (pg. 190, Abstract).
Regarding claim 6, Davidson discloses a method for preparing a thin film wherein xanthan gum, locust bean gum, carrageenan and pullulan are mixed and hydrated in hot purified water to form a gel. The gel is stored in a refrigerator overnight to form a film layer [0065].
Regarding claim 9, Davidson teaches that the monolayer film made from a hydrocolloid such as xanthan gum, locust bean gum, carrageenan and pullulan may contain a plasticizer (claims 80 and 81) and that methods for producing the film layer and incorporating plasticizers in the film layer are well known in the art [0044].
Regarding claim 10, Davidson teaches that the medicant in the film may be an anti-histamine, antibiotics, cardio strengthening agents, local narcotic agents, cough curing agents, blood pressure depressing agents, and agents for curing virulent carcinoma or ulcers [0037].
Regarding claim 12, Davidson discloses a method for preparing a thin film wherein xanthan gum, locust bean gum, carrageenan and pullulan are mixed and hydrated in hot purified water to form a gel. The gel is stored in a refrigerator overnight to form a film layer [0065]. Chlorhexidine is combined with carboxymethylcellulose powder, modified food starch, carrageenan, sucralose, talc, catnip and a lipid to produce a powder matrix [0083]. Sucralose is included as an intense sweetener and catnip is included as a flavorant [0083].
With regards to the “area density” limitations of instant claim 13, the prior art teaches the same oral thin film as claimed and therefore, the area density properties are necessarily present; the Examiner directs attention to MPEP 2112.01 (II) which states: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
Regarding claim 16, Davidson discloses that the oral film is orally administered to a cat once a day for three weeks until a satisfactory clinical response is obtained [0087].
Regarding claim 17, Davidson discloses a method for preparing a thin film wherein xanthan gum, locust bean gum, carrageenan and pullulan are mixed and hydrated in hot purified water to form a gel. The gel is stored in a refrigerator overnight to form a film layer [0065]. Chlorhexidine is combined with carboxymethylcellulose powder, modified food starch, carrageenan, sucralose, talc, catnip and a lipid to produce a powder matrix [0083]. The powder matrix is applied to the upper exposed surface of the film layer via static spray gun. The powder matrix layer and film layer together comprise a medicant composition [0084].
Regarding claim 18, Davidson discloses a method for preparing a thin film wherein the medicament is combined with carboxymethylcellulose powder [0083].
Regarding claim 19, Davidson teaches that that the size of particulate in the powder matrix can be in the range of 10 mesh to 400 mesh or finer [0040].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claim 1, Davidson does not teach the inclusion of polyethylene oxide (PEO). However, this deficiency is cured by Salehi.
Salehi teaches that PEO-based mucoadhesive buccal films are resistant against fracture and tear and that low molecular weight PEO has a fast dissolution rate in oral saliva (pg. 176 Introduction).
Regarding claim 19, Davidson does not disclose a particle size for the carboxymethylcellulose powder included in Example XII.
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claim 1, the idea for combining compounds each of which is known to be useful for the same purpose, in order to form a composition which is to be used for the same purpose, flows logically from their having been used individually in the prior art. See In re Kerkhoven 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). As shown by the recited teachings, the instant claims define nothing more than the concomitant use of conventional mucoadhesive polymers used in oral dissolving films. It would follow that the recited claims define prima facie obvious subject matter. See MPEP 2144.06.
Furthermore, the average molecular weight of the PEO in the film is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal average molecular weight of PEO in order to best achieve the desired results as such would provide advantageous formulation effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Salehi teaches that low molecular weight PEO has a fast dissolution rate in oral saliva (pg. 176 Introduction). The Examiner considers it prima facie obvious to optimize the average molecular weight of PEO present in the film, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the average molecular weight of the PEO would affect the rate of dissolution of the film in the mouth and therefore be an optimizable variable.
Regarding claim 19, the particle size of the carboxymethylcellulose powder in example XII is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal particle size in order to best achieve the desired results as such would provide advantageous biological effect. It would have been prima facie obvious to one of ordinary skill in the art at the time of the invention to engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F. 2d 454, 105 USPQ 233 (CCPA 1955). In the instant case, Davidson teaches that the size of particulate in the powder matrix can be in the range of 10 mesh to 400 mesh or finer [0040]. The Examiner considers it prima facie obvious to optimize the particle size of the carboxymethylcellulose powder , absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the particle size is preferably less than 10 mesh and therefore is an optimizable variable.
Claims 11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Davidson (U.S. Application No. 2005/0136096, publication date: 6/23/2005, cited in the IDS filed 7/25/2023, of record), as applied to claims 1-6, 9, 10, 12-14, and 16-19 above, and further in view of Kizawa (U.S. Patent No. 4,517,173, issue date: 5/14/1985, of record), as evidenced by Yuan et. al. (Trends in Food Science and Technology, pg. 139-153, publication year: 2021, of record).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Regarding claims 11 and 21, Davidson teaches the relevant limitations of claim 1 as described above.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 11 and 21, Davidson does not teach an additional layer of the film opposite the side of the second polymer. However, this deficiency is cured by Kizawa.
Kizawa discloses a method of preparation of an oral film that comprises first pouring the pharmaceutical layer, followed by an intermediate layer, and finally a poor water-soluble layer containing shellac is added (col. 5 and 6 example 1, line 47). Kizawa also teaches that the poor water-soluble layer has poor water solubility and consequently, the pharmaceutical component of the pharmaceutical layer is not eluted and it can be retained in the buccal cavity for long hours without giving a feeling of contacting an extraneous material (col. 7 and 8, Industrial Utilization). Yuan teaches that shellac is a natural polymer (pg. 139, Abstract).
Finding of a Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 11 and 21, it would have been prima facie obvious to one of ordinary skill in the art of filing to apply an additional layer opposite the side of the second polymer on the oral dissolving film embraced by Davidson. One would have understood in Kizawa that an oral dissolving film may contain a layer opposite a medicament layer made up of a poorly water-soluble polymer such as shellac. It would have been obvious to include such a layer opposite the powder matrix layer embraced by Davidson. One of ordinary skill in the art of filing would have been motivated to include an additional polymer layer opposite the powder matrix in order to ensure that the medicament is not eluted too quickly and that the oral dissolving film can be retained in the buccal cavity for long hours. The artisan of ordinary skill would have had reasonable expectation of success because Kizawa teaches that additional polymer layers comprised of poorly water-soluble ingredients may be included in a mucoadhesive buccal patch.
Response to Arguments
Applicant's arguments filed 12/5/2025 have been fully considered but they are not persuasive.
On pages 6 and 8, Applicant argues that the skilled artisan has no motivation to modify Davidson based on Salehi. This is not found persuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Davidson teaches that auxiliary adhesion compositions that adhere to the oral mucosa may be included in the oral dissolving film and that all examples of composition provided are given without limiting the use or inclusion of other comparable functionally equivalent compositions even though such comparable or functionally equivalent compositions are not listed [0031]. The artisan of ordinary skill in the art would, in view of Salehi, understand that the inclusion of polyethylene oxide would impart its mucoadhesive properties to the oral dissolving film and would therefore be motivated to include polyethylene oxide in the oral dissolving film taught by Davidson.
On page 6, Applicant argues that the reliance on Kerkhoven is misplaced because the Examiner is making a substitution rather than a combination. This is not found persuasive. As described in the rejection statement above, Davidson teaches that auxiliary adhesion compositions that adhere to the oral mucosa may be included in the oral dissolving film and that all examples of composition provided are given without limiting the use or inclusion of other comparable functionally equivalent compositions even though such comparable or functionally equivalent compositions are not listed [0031]. Salehi teaches that PEO-based mucoadhesive buccal films are resistant against fracture and tear and that low molecular weight PEO has a fast dissolution rate in oral saliva (pg. 176 Introduction). The claims therefore describe the concomitant use of conventional mucoadhesive polymers used in oral dissolving films, not a substitution. Therefore, the argument is not persuasive and the rejection is maintained.
On page 8, Applicant argues that Davidson does not explain how to select polymers for the auxiliary adhesion composition that form a protective layer on one side of the multilayer oral thin film. This is not found persuasive. In response, the Examiner refers Applicant to MPEP 2145 (X)(A) which states:
Applicants may also argue that the combination of two or more references is “hindsight” because “express” motivation to combine the references is lacking. However, there is no requirement that an “express, written motivation to combine must appear in prior art references before a finding of obviousness.” See Ruiz v. A.B. Chance Co., 357 F.3d 1270, 1276, 69 USPQ2d 1686, 1690 (Fed. Cir. 2004). See MPEP § 2141 and § 2143 for guidance regarding establishment of a prima facie case of obviousness. (Emphasis added.)
Please refer to MPEP 2141.03(I) regarding the factors to consider when determining level of ordinary skill: “A person of ordinary skill in the art is also a person of ordinary creativity, not an automation.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle." Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ." Id. at 418, 82 USPQ2d at 1396.
On page 8, Applicant argues that a skilled person following Davidson’s teachings would focus on dissolution time rather than protecting the multilayer film from erosion and would therefore not replace the polymers in paragraph [0031] of Davidson with polyethylene oxide since no functionally equivalent compositions would result. This is not found persuasive. As described in the rejection statement above, Davidson teaches that auxiliary adhesion compositions that adhere to the oral mucosa may be included in the oral dissolving film and that all examples of composition provided are given without limiting the use or inclusion of other comparable functionally equivalent compositions even though such comparable or functionally equivalent compositions are not listed [0031]. Salehi teaches that PEO-based mucoadhesive buccal films are resistant against fracture and tear and that low molecular weight PEO has a fast dissolution rate in oral saliva (pg. 176 Introduction). Based on these teachings, one of ordinary skill in the art of filing would have understood that PEO included in mucoadhesive buccal films has a direct effect on dissolution time and would therefore be motivated to include PEO in the teachings of Davidson in order to adjust the dissolution time to the desired time frame. Therefore, the argument is not persuasive and the rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH ANNE MEYERS whose telephone number is (571)272-2271. The examiner can normally be reached Monday-Friday 8am-5pm ET.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614