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 .
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.
Claim Status
Applicant’s amendment of 03/25/2026 is acknowledged. Claims 1-3, 7-13, 16-18, and 20-25 are amended; claims 4-6, 14-15, and 19 are cancelled; claim 26 is new. Claims 1-3, 7-13, 16-18, and 20-26 are currently pending.
Election/Restrictions
An election of invention/species was required in the instant application as detailed in the Office action dated 09/03/2025.
Applicant’s arguments submitted on 03/25/2026 with respect to the restriction requirement have been fully considered but were not found to be persuasive.
Applicant argues that “5% to 40% of dextrin; the dextrin is one or more of maltodextrin, hydroxypropyl-β-cyclodextrin, glucosyl-β-cyclodextrin and sulfobutyl-β-cyclodextrin” are special technical features that make a contribution over the prior art. This is not found persuasive because the claimed technical features do not make a contribution over the prior art in view of Lin and Dhote, as discussed in detail the prior art rejections and response to arguments below, and are therefore not special technical features. Thus, Groups I-III lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-3, 7-13, 16-18, and 20-26 are pending in the application. Claims 8-10 and 20-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 10/23/2025. New claim 26 falls within the scope of elected Group I. Accordingly, claims 1-3, 7, 11-13, 16-18, and 22-26 are being examined on the merits herein.
Priority
The instant application is a 371 of PCT/CN2021/083192 filed on 03/26/2021 and claims foreign priority to CN202011145109.6 filed on 10/23/2020 as reflected in the filing receipt dated on 09/20/2023. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Withdrawn Objections and Rejections
Applicant’s amendments to the claims have overcome the previous objections to the claims. Thus, the objections are hereby withdrawn.
Applicant’s amendments to the claims have overcome/rendered moot the previous 112(b) rejections. Thus, the rejections are hereby withdrawn. Applicant’s amendment to the claims has prompted the new grounds of rejection presented herein.
Applicant’s cancellation of claim 19 has rendered moot the previous rejections of the claim. Thus, the rejections are hereby withdrawn.
The previous rejections under 35 U.S.C. 103 have been revised only to address Applicant’s amendments to claims 22 and 25 and introduction of new claim 26.
Claim Objections
Claim 2 is objected to because of the following informalities:
Claim 2 recites the limitation “rasagiline or the pharmaceutical salt” in line 11. The claim should read "rasagiline or the pharmaceutically acceptable salt thereof" to clarify that the salt refers to the rasagiline salt recited in claim 1 and does not refer to a different and previously unrecited pharmaceutical salt.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 2 and 3 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.
Claim 2 recites at least four instances of the limitation “in use” [lines 11-14]. While the claim is drawn to a product, the inclusion of the phrase “in use” makes it unclear whether Applicant is attempting to claim a process without reciting active method steps involved in the process. How is the component in use if it is not recited as part of a process comprising active steps? Therefore, the scope of the claim is indefinite. Claim 3 is rejected by virtue of its dependence on claim 2, as it fails to resolve the ambiguity in question.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
New Matter Rejection
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The limitation “5%-25%” has been added to claim 25 in the amendment filed on 03/25/2026. However, the instant disclosure does not provide support for the entirety of the scope encompassed by the limitation “5%-25%” as recited in the amended claims. In particular, the instant specification and claims as originally filed only provide support for dextrin concentrations of 5%, 10%, 20%, or 25% within the amended range.
If Applicant believes this rejection is in error, Applicant must disclose where in the specification support for the entire scope of the amendment(s) and/or new claims can be found. As a result, claim 25 represents new matter.
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.
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 1-3, 7, 11, 16, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20120214877A1; published 08/23/2012; related to CN102048717A cited on IDS of 07/11/2023) in view of Dhote et al. (AJPER, vol. 4, p. 1-29; published: 06/2015) and as evidenced by Pareek et al. (WO2010052727A1; published: 05/14/2010).
Lin, throughout the reference, discloses mucosal film preparations of rasagiline or a pharmaceutically acceptable salt thereof [claims 1 and 7]. In an exemplary embodiment, an oral mucosal film comprises: 1% rasagiline; 30% polyvinyl alcohol; 3% glycerol; 1% titanium dioxide; 5% Tween 80; 59.5% water; and 0.5% tocopherol [0069, example 11-1]. Each component is represented as its weight percent based on the total weight of the composition [0025]. Lin explicitly teaches wherein the above mixture is dried into a film [0069], suggesting that water is not present in the final product and, therefore, does not contribute to the weight of the dried film. As such, an ordinarily skilled artisan would determine that the dried film product comprises: 2.5% rasagiline; 74% polyvinyl alcohol; 7.4% glycerol; 2.5% titanium dioxide; 12.3% Tween-80; and 1.2% tocopherol.
Regarding the rasagiline or a pharmaceutical salt recited in claim 1: The amount of rasagiline in the film of Lin lies within and thus renders obvious the claimed range. Further, Lin explicitly teaches that pharmaceutically acceptable salts of rasagiline include hydrochloride, mesylate, ethyl sulfonate, or sulfate [0011]. Therefore, one of ordinary skill in the art before the effective filing date of the claimed invention could at once envisage an embodiment wherein the rasagiline is in the form of rasagiline mesylate, which reads on the pharmaceutically acceptable salt of rasagiline as instantly claimed, as well as Applicant’s elected species of rasagiline.
Regarding the polymer film-forming material recited in claim 1: Polyvinyl alcohol reads on the polymer film-forming material as evidenced by instant claim 2, as well as a component of Applicant’s elected species of polymer film-forming material. The amount of polyvinyl alcohol lies within and thus renders obvious the claimed range.
Regarding the other excipients recited in claim 1: The other components in the film comprise 23.4% of the film, which lies within and thus renders obvious the instantly claimed range.
Regarding claim 2: As discussed above, polyvinyl alcohol reads on the instantly claimed polymer film-forming material and is sufficient to meet an alternative of the claim. Additionally, regarding the one or more other excipients, titanium dioxide reads on the claimed colorant as evidenced by instant claim 3 and tocopherol is an antioxidant as evidenced by Lin [0012] and are each sufficient to meet an alternative of the claim. Additionally, regarding the amount of rasagiline or the pharmaceutical salt in use, the amount of rasagiline lies within and thus is sufficient to meet an alternative of the claim.
Regarding claim 3: The film of Lin comprises titanium dioxide, which satisfies the instantly claimed condition (5), and is sufficient to meet an alternative of the claim, as well as Applicant’s elected species of colorant. Additionally, the film of Lin comprises polyvinyl alcohol, which satisfies the instantly claimed condition (8), and is sufficient to meet an alternative of the claim.
Regarding claim 7: The amount of rasagiline exemplified by Lin closely approaches the instantly claimed amounts of 1% and 5% of rasagiline or the pharmaceutical salt, the amount of polyvinyl alcohol exemplified by Lin closely approaches the instantly claimed amounts of 70% and 80% of the polymer film-forming material, and the amount of other components exemplified by Lin closely approaches the instantly claimed amount of 20% of other excipients. A prima facie case of obviousness exists where the claimed ranges or amounts “do not overlap with the prior art but are merely close” such that “one skilled in the art would have expected them to have the same properties”. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Note: MPEP 2144.05(I). Each disclosed concentration is sufficient to meet an alternative of the claim. Additionally, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to adjust the amount of rasagiline within the range of 0.1% to 40% as taught by Lin [claim 3], which overlaps the instantly claimed amounts of rasagiline or the pharmaceutical salt, using the disclosed 2.5% as a starting point for routine optimization because Lin teaches that any amount within this range is suitable for forming a stable rasagiline composition. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Note MPEP 2144.05.
Regarding claim 11: The amount of titanium dioxide exemplified by Lin lies within and thus renders obvious the range recited in condition (5) of the instant claim and, therefore, meets an alternative of the claim.
Regarding claim 16: The amount of titanium dioxide exemplified by Lin closely approaches the instantly claimed amount of 4% of colorant. A prima facie case of obviousness exists where the claimed ranges or amounts “do not overlap with the prior art but are merely close” such that “one skilled in the art would have expected them to have the same properties”. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Note: MPEP 2144.05(I). Therefore, the concentration is sufficient to meet an alternative of the claim.
Regarding claim 24: The amount of polyvinyl alcohol exemplified by Lin lies within and thus renders obvious the instantly claimed range of polymer film-forming material.
Regarding claim 26: Lin further teaches an exemplary embodiment, wherein an oral mucosal film comprises: 1% rasagiline; 30% polyvinyl alcohol; 3% glycerol; 1% titanium dioxide; 5% Tween-80; and 60% water [0069, example 11-4]. As discussed above, Lin explicitly teaches wherein the above mixture is dried into a film, suggesting that water is not present in the final product and, therefore, does not contribute to the weight of the dried film. As such, an ordinarily skilled artisan would determine that the dried film product comprises: 2.5% rasagiline; 75% polyvinyl alcohol; 7.5% glycerol; 2.5% titanium dioxide; and 12.5% Tween 80. As discussed above, polyvinyl alcohol reads on the claimed film-forming material and titanium dioxide is a colorant which reads on the claimed other excipient(s). Glycerol (same as glycerin) and Tween 80 (brand name for polysorbate 80) are known plasticizers used in pharmaceutical films Pareek [pg. 5, third para.]. Therefore, the composition consists only of the instantly recited components with the exception of dextrin, wherein this deficiency is cured in view of Dhote as discussed below.
Lin does not expressly teach that the film comprises dextrin, specifically Applicant’s elected species of hydroxypropyl-β-cyclodextrin, as recited in claims 1, 23 and 26, the amount of dextrin recited in claims 1, 25, and 26.
Dhote, which throughout the reference reviews oral dissolving film formulations, teaches that the unpleasant taste of active pharmaceutical ingredients can be reduced by minimizing drug dissolution within the oral cavity [pg. 8]. β-cyclodextrins are widely used to form stable complexes with the drug, which decreases the amount of drug particles exposed to the taste buds [pg. 20-21]. Dhote further provides an example wherein palatable ibuprofen has been formulated at ratios of drug:hydroxypropyl-β-cyclodextrin ranging from 1:11 to 1:15 [pg. 21].
Regarding the dextrin recited in claims 1, 23, and 26: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the film of Lin by further including a taste-masking agent, such as hydroxypropyl-β-cyclodextrin of Dhote, to minimize the amount of rasagiline exposed to the taste buds.
The Examiner notes that the inclusion of hydroxypropyl-β-cyclodextrin in the film is also sufficient to meet an alternative of claim 2.
Regarding the amount of dextrin recited in claim 1: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 37.5% hydroxypropyl-β-cyclodextrin by weight of the film (calculated by Examiner based on the ratio of drug:hydroxypropyl-β-cyclodextrin taught by Dhote), which lies within and thus renders obvious the instantly claimed range of dextrin, as a starting point for routine optimization of the taste of the film because Dhote teaches that this ratio has been successfully used to mask the taste of drug in oral dissolving films.
Regarding the amount of dextrin recited in claim 25: Dhote further teaches that the bitter taste of carbetapentane citrate was reducing by preparing a 1:1 complex with cyclodextrin. Together with Dhote’s example of hydroxypropyl-β-cyclodextrin-complexed ibuprofen, the prior art clearly teaches that the ratio of drug:cyclodextrin is a tunable parameter that varies by drug type and desired effect. Thus, it would have been prima facie obvious to manipulate the concentration of hydroxypropyl-β-cyclodextrin within the composition taught by the combination of Lin and Dhote according to known methods to achieve a desired taste-masking effect. "[W]here 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, 456, 105 USPQ 233, 235 (CCPA 1955). Given that Applicant did not point out the criticality of the dextrin concentration of the invention, it is concluded that the normal desire of scientists or artisans to improve upon what is already generally known would provide the motivation to determine where in a disclosed set of ranges is the optimum concentration. NOTE: MPEP 2144.05.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the film of Lin as proposed because Dhote teaches that taste-masking agents are routinely used in the art to improve the palatability of oral dissolving films, such as that of Lin.
It is noted that the recitation “sublingual” in the claims an intended use of the claimed composition. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Since the structure of the oral mucosal film taught by the combination of Lin and Dhote is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02.
Claims 1-3, 7, 11-13, 16, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20120214877A1; published 08/23/2012; related to CN102048717A cited on IDS of 07/11/2023) in view of Dhote et al. (AJPER, vol. 4, p. 1-29; published: 06/2015), as applied to claims 1-3, 7, 11, 16, and 23-26 above, and further in view of Patil et al. (IJPLCP, vol. 11, p. 6760-6768; published: 07/2020) and as evidenced by Pareek et al. (WO2010052727A1; published: 05/14/2010).
The combination of Lin and Dhote teach the invention(s) of claims 1-3, 7, 11, 16, and 23-26 as discussed in detail above and further incorporated herein.
The combination of Lin and Dhote does not expressly teach that the polymer film-forming material further comprises hydroxypropyl methylcellulose as required by Applicant’s elected species, or wherein the mixture has a mass ratio of hydroxypropyl methylcellulose and polyvinyl alcohol as recited in claims 12 and 13, or that the film-forming material is one of those recited in claim 22.
Patil, throughout the reference, teaches the development of fast dissolving oral film formulations and evaluates the effect of different film forming polymers on properties such as tensile strength, disintegration time, and percentage drug dissolution [abstract]. Ultimately, film formulations containing a blend of hydroxypropyl methylcellulose E15 and polyvinyl alcohol were found to exhibit superior properties, including fast disintegration times and quicker drug release [pg. 3762-6765, tables 1-3, formulations 7-9].
Regarding claims 12, 13, and 22: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the film taught by the combination of Lin and Dhote by further including hydroxypropyl methylcellulose E15 as a film former because Patil teaches that its combination with polyvinyl alcohol achieves faster drug release in oral dissolving films compared to either polymer alone.
Regarding the instantly claimed mass ratios of hydroxypropyl methylcellulose to polyvinyl alcohol, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a 50:50 mass ratio of hydroxypropyl methylcellulose to polyvinyl alcohol (also written as 1:1), as a starting point for routine optimization of the film because Patil teaches that this ratio resulted in the fastest film disintegration times and fastest drug release in-vitro [pg. 3762-6765, tables 1-3, formulation 7]. The mass ratio taught by Patil lies within and thus renders obvious the range recited in instant claim 12 (for example, a mass ratio of 30:30, also written as 1:1, lies within the claimed range) and closely approaches the ratios recited in instant claim 13 (for example, 45:40, also written as 1:0.9). A prima facie case of obviousness exists where the claimed ranges or amounts “do not overlap with the prior art but are merely close” such that “one skilled in the art would have expected them to have the same properties”. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Note: MPEP 2144.05(I).
The presence of hydroxypropyl methylcellulose satisfies the instantly claimed condition (1) of claim 22, and is sufficient to meet an alternative of the claim. The Examiner notes that the open claim language “comprises” recited in parent claim 1 does not exclude the presence of polyvinyl alcohol in the film so long as the hydroxypropyl methylcellulose is present in the range of 30% to 85% by mass relative to the total components of the film, as required by parent claim 1. Because a 1:1 mass ratio of hydroxypropyl methylcellulose to polyvinyl alcohol equates to 37% by mass of hydroxypropyl methylcellulose (calculated by Examiner based on 74% by mass of film forming material in the unmodified composition), the conditions of parent claim 1 are still satisfied.
The Examiner notes that the inclusion of hydroxypropyl methylcellulose in combination with polyvinyl alcohol in the film is also sufficient to meet alternatives of claims 2, 3, and 11.
One of ordinary skill in the art would have a reasonable expectation of success in modifying the film taught by the combination of Lin and Dhote with the teachings of Patil as proposed because Patil teaches that the combination of polyvinyl alcohol and hydroxypropyl methylcellulose is known to be used in the development of dissolving oral film formulations, and Lin teaches that its carrier may contain one or more polymers including polyvinyl alcohol polymers and cellulose polymers (Paragraph 0018).
Claims 1-3, 7, 11-13, 16-18, and 22-26 are rejected under 35 U.S.C. 103 as being unpatentable over Lin et al. (US20120214877A1; published 08/23/2012; related to CN102048717A cited on IDS of 07/11/2023) in view of Dhote et al. (AJPER, vol. 4, p. 1-29; published: 06/2015) and Patil et al. (IJPLCP, vol. 11, p. 6760-6768; published: 07/2020), as applied to claims 1-3, 7, 11-13, 16, and 22-26 above, and further in view of Park et al. (WO2010150930A1; published: 12/29/2010) as evidenced by ACS (webpage, <https://www.acs.org/molecule-of-the-week/archive/s/stevioside.html>; published: 05/28/2018) and as evidenced by Pareek et al. (WO2010052727A1; published: 05/14/2010).
The combination of Lin, Dhote, and Patil teach the invention(s) of claims 1-3, 7, 11-13, 16, and 22-26 as discussed in detail above and further incorporated herein.
The combination of Lin, Dhote, and Patil does not expressly teach that the film further comprises Applicant’s elected species of sweetener, steviol glycoside, wherein the steviol glycoside is present in the amount recited in claims 17 and 18, or Applicant’s elected species of essence, strawberry.
Park, throughout the reference, teaches fast dissolving oral films comprising at least one water-soluble polymer, at least one medically active ingredient, a stevioside-based sweetener as a taste improver, and at least one first sweetener as a taste masking agent [claim 1].
Regarding claims 17 and 18: Park teaches that stevioside, which is a steviol glycoside as evidenced by ACS [ACS, pg. 1], stevioside, which has a delayed onset of sweetness, is preferable for controlling the unpleasant taste felt when the drug is absorbed and remains in the oral cavity [0055]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the film taught by the combination of Lin, Dhote, and Patil by further including stevioside as a sweetener to improve the film’s aftertaste.
Regarding the instantly claimed amount of sweetener, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use 10% stevioside by weight of the film, which lies within and thus renders obvious the ranges recited in instant claims 17 and 18, as a starting point for routine optimization of the film because Park teaches that this amount is useful for successfully masking the bitter and unpleasant taste of a drug [0050].
The Examiner notes that the inclusion of stevioside in the film is also sufficient to meet alternatives of claims 2, 3, and 11.
Regarding Applicant’s elected species of essence: Park teaches that it is necessary to include various fragrances, such as strawberry, in oral dissolving films since the product is dissolved and absorbed in the oral cavity [0082-0085]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the film taught by the combination of Lin, Dhote, and Patil by further including strawberry fragrance/essence, which is sufficient to meet alternatives of instant claims 2 and 3, by using 1% by weight of the film, which lies within and thus renders obvious the range recited in an alternative of instant claim 11, as a starting point for routine optimization because Park teaches that this amount is useful for developing palatable oral dissolving films [0085].
One of ordinary skill in the art would have a reasonable expectation of success in modifying the film taught by the combination of Lin, Dhote, and Patil as proposed because Park teaches that stevioside and fragrances are advantageous in oral dissolving films comprising a water-soluble polymer (e.g. polyvinyl alcohol and/or hydroxypropyl methylcellulose), a medically active ingredient (e.g. rasagiline mesylate), and a first sweetener (e.g., hydroxypropyl-β-cyclodextrin).
Response to Arguments
Applicant’s arguments submitted on 03/25/2026 with respect to rejections under 35 U.S.C. 103 have been fully considered but were not found to be persuasive.
Applicant argues that Lin does not teach dextrin and its amount and that the hydroxypropyl-β-cyclodextrin in Dhote has a different function and, thus, one of ordinary skill in the art would not have a reasonable expectation of success in modifying Lin as proposed. This argument was not found to be persuasive. First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the feature upon which applicant relies (i.e., the function of hydroxypropyl-β-cyclodextrin) is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Even if it were a claimed feature, the Examiner directs Applicant's attention to MPEP 2112, section I: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art's functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In instant case, the fact that Applicant has found out that the prior art's hydroxypropyl-β-cyclodextrin can improve the stability and dissolution of the film is not patentably distinguishable since the prior art teaches that the same ingredient is known to be used in oral dissolving films, and Applicant would merely be attempting to claim an allegedly unrecognized property of the prior art.
Applicant further argues that the active pharmaceutical ingredient in Dhote is completely different from the active pharmaceutical ingredient of Lin/the present application and, thus, one of ordinary skill would not have known whether a component in Dhote could also be successfully used in Lin/the present application. The Examiner respectfully directs Applicant’s attention to MPEP 2143.02(II), which states, “Obviousness does not require absolute predictability, but at least some degree of predictability is required.” As evidenced by the work of Dhote, the formation of inclusion complexes of drugs with cyclodextrins is a technique routinely used in the art to predictably produce oral formulations wherein the unpleasant taste of the drug—including but not limited to ibuprofen—is masked. Dhote even notes that the amphophilic nature of cyclodextrins makes them capable of interacting with a large variety of guest molecules, and that β-cyclodextrins have a cavity size suitable for the widest range of drugs [pg. 20-21; previously cited]. Dhote’s exemplary teaching of hydroxypropyl-β-cyclodextrin-complexed ibuprofen simply provides a starting point for optimization of the ratio between hydroxypropyl-β-cyclodextrin of Dhote and the rasagiline of Lin. It would have been customary for an ordinarily skilled artisan to look within the prior art teachings to optimize the technique according to known and predictable methods in order to achieve an oral dissolving film with an acceptable level of taste masking. Absent of any objective evidence demonstrating that the prior art components cannot be combined as proposed, an ordinarily skilled artisan would reasonably expect that including the hydroxypropyl-β-cyclodextrin of Dhote in the oral disintegrating film of Lin would produce the predictable result of a rasagiline mucosal film with improved taste. See Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348, 1364, 1367–68 (Fed. Cir. 2007) (reasoning that "the expectation of success need only be reasonable, not absolute").
Applicant further argues that Lin in view of Dhote fails to teach all limitations of amended claim 25 and new claim 26. Regarding claim 25, as discussed in detail above and absent a demonstration of the criticality of the claimed range, it would have been prima facie obvious to manipulate the concentration of hydroxypropyl-β-cyclodextrin within the composition taught by the combination of Lin and Dhote according to known methods to achieve a desired taste-masking effect. Regarding claim 26, as discussed in detail above, the combination of Lin and Dhote as evidenced by Pareek teaches a composition consisting only of the instantly recited components and thus meets the claim.
Regarding Applicant’s argument that inclusion of antioxidant is necessary to achieve Lin’s inventive purpose, the Examiner notes that while inclusion of an antioxidant in Lin’s exemplary mucosal films [examples 11-1, 11-2, and 11-3] appears to slow decomposition of rasagiline at extreme temperatures over several days (e.g., 60°C for 10 days) compared to a film without an antioxidant [example 11-4; see Lin’s table 24], its exclusion does not render the film inoperable for its intended purpose as a mucosal film. According to the portions of Lin cited by Applicant [0008-0009; 0022], the reference does not expressly criticize the exclusion of an antioxidant but demonstrates the advantages of including one, particularly in the context of a transdermal patch. ‘A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.' In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994).
In view of the foregoing, the prior art rejections of record are maintained.
Conclusion
No claim is 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 SARAH CLINKSCALES WISTNER whose telephone number is (571)270-7715. The examiner can normally be reached Monday - Thursday 8:00 AM - 5:00 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH C WISTNER/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
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