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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 06 Oct 2025 has been entered.
Claims 1-5 and 7-17 remain pending in the application.
Claims 2 and 5 are amended.
Claim 6 is cancelled.
Claims 10-16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1-5, 7-9 and 17 are under consideration to the extent that the orodispersible thin film is oral, the film forming polymer is HPMC, the plasticizer is polyethylene glycol, and that the ingredient that acts as an adsorbent is titanium dioxide.
37 C.F.R. 1.121 – Manner of making Amendments
Claim 2 has been amended in the claim set filed 06 Oct 2025 to replace “9 kg/mm2” with “9 kg/cm2.” The applicant did not present markings to indicate the changes that were made relative the immediate prior version. The applicant is reminded that amended claims need to be presented in accordance with MPEP 714(II)(C).
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: in the prior-filed application, Application No. IN201821014188, the applicant failed to provide adequate written description support for claims 4 and 17. Accordingly, priority cannot be granted at this time, thus claims 4 and 17 are granted the filing date of the prior application PCT/IN2019050299 (11 Apr 2019).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. IN20182104188, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application ‘188 fails to provide support for the addition of the generic group of “plasticizers” and specifically does not provide support for polyethylene glycol. Accordingly, claims 4 and 17 are not entitled to the benefit of the prior application.
Response to Arguments
The applicant provides a quotation from an article by Ruchi Sharma for evidence that a film inherently has to have a plasticizer in it to make materials more flexible or elastic (pages 9-11 of remarks). The examiner is not persuaded by this as the applicant has not established that orodispersible films inherently have plasticizers. While it may be understood that plasticizers are a common component for films, this is not sufficient support for establishing possession of the general category of plasticizers or the specific plasticizer of polyethylene glycol. The examiner notes that MPEP 2163.07(a), as cited by the applicant, is directed to inherent functions and properties that are present in the invention and not to components that may be included. The examiner does not doubt that plasticizers such as polyethylene glycol would be readily incorporated into films, but there is a difference between what one would recognize as an obvious component and establishing possession sufficient for the written description. The entitlement to a filing date does not extend to subject matter, which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977).
The applicant further argues that the invention is an orodispersible film and regarding the terms “plasticizer” and “polyethylene glycol” that the ‘claims or its terms cannot be selectively construed separate from the context in which they are used, the claim should be read with all its elements together in its entire[t]y and the meaning that comes out should be construed” (page 11 off remarks). While the examiner agrees that the terms used the by applicant may be understood in the context of the invention, this again does not provide support for the “plasticizer” and “polyethylene glycol.” While the applicant has support for the broad recitation of an “orodispersible film” this does not provide support for possession of everything that one may recognize as potentially being included in an orodispersible film.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 07 Jul 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claim 2 pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 07 Jul 2025 is hereby withdrawn in light of applicants amendment of the claims.
Rejections Maintained
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7-9 and 17 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.
Claims 1-5, 7-9 and 17 are indefinite in reciting “paper like surface roughness” in claims 1 and 5. The term “paper like surface roughness” is a relative term which renders the claims indefinite. The term “paper like surface roughness” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paper may be made from a variety of disparate materials which lead to varying textures and degrees of roughness. Additionally, as there is no clear standard for comparison, the phrase is subjective in that multiple practitioners may evaluate the same film and draw alternative conclusions about whether the films roughness is paper like. This additionally renders claims 4 and 7 as indefinite with the recitation that the film comprises an ingredient that imparts “required roughness” to the surface of the substrate. As the limitation of “paper like surface roughness” is relative, it is unclear what the “required roughness” of the substrate is, thereby rendering the claim indefinite. Additionally, it is not clear whether the “required roughness” as recited in claims 4 and 7 are equivalent to the “paper like surface roughness” as recited in claims 1 and 5 or if a different degree of roughness is required.
Response to Arguments
Applicant's arguments filed 06 Oct 2025 have been fully considered but they are not persuasive. Applicant argues that the phrase “paper like surface roughness, porosity and absorptivity for the purpose of printing” should be interpreted under 112(f) (page 13 of remarks). Applicant specifically looks to use of the word “for” in the phrase as evidence that it meets the requirements for 112(f) interpretation (pages 13-14 of remarks). The examiner does not agree that “paper like surface roughness, porosity and absorptivity” satisfies the requirement for interpreting under 112(f) as the phrase does not use “means” or a substitute for “means” that is a generic placeholder (see MPEP 2181(I)(A). The examiner maintains that the phrase is indefinite but this does not in turn mean that the phrase is to be understood as a generic placeholder for “means.” The claims fail the first prong in the analysis for 112(f) and thus are not interpreted under 112(f).
The applicant points to examples of the invention in the specification for how the phrase is to be interpreted. The applicant states that the examples can be “observed and studied to understand and define the structure of the film” (page 13 of remarks). The specification does not define what limitation “paper like surface roughness, porosity and absorptivity for the purpose of printing” invokes and it is not clear how the examples are to be studied in order to provide a definition. Overall, the examiner maintains that the claim is not to be interpreted under 112(f) and that the specification does not provide a definition that clarifies the ambiguity in the claim and thus claim in considered to remain indefinite.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Janβen et al. (International Journal of Pharmaceutics 441 (2013) 818– 825) as evidenced by the instant specification.
Janβen teaches that orodispersible films (ODF) are an ideal oral dosage form for paediatric and geriatric drug delivery (page 818 paragraph 1). Janβen teaches an orodispersible film where the ODF was first cast and subsequently had API added using an industry-relevant printing technique (page 818 paragraph 3). Janβen teaches that drug-free ODFs were produced by solvent casting and subsequently printed on (page 820 section 3.1 paragraph 1). Therefore, the ODFs of Janβen are understood to consist of a drug-free film which serves as the “substrate for making an orodispersible thin film” as recited in claim 5, to which an ink is additionally applied. Example ODFs were printed with the API Tadalafil and rasagiline mesylate using flexography printing technology (page 819 paragraph 2). The thickness of the ODF was 54.7 ± 0.5 μm (page 822 paragraph 2), and as there is no indication in the claim as to the parameters of “thin”, the ODF of Janβen is understood as reading on the “orodispersible thin film” of instant claims 1 and 5.
Janβen teaches that the challenge of API printing onto ODFs is to avoid film disintegration, rupturing or crumbling during the printing process and to maintain the fast dissolving properties (page 819 paragraph 1, page 820 section 3.1 paragraph 1). Therefore, a combination of a HPMC-based drug-free film and an ink based on ethanolic HPC-solution was chosen as, in contrast to HPC, HPMC does not fully dissolve within ethanol and the film was not supposed to disintegrate during the printing process (page 820 section 3.1 paragraph 1). As evidenced by the instant specification, cavities, or depressions, in films form when films made from hydrophilic polymers are dissolved by water based inks or inks containing any hydrophilic ingredient (page 5 paragraph 3, page 6 paragraph 2). As further evidenced by the specification, inks per the invention contained ethanol (page 13 Table 1) and the film substrates were formed from HPMC (page 18 Table 9). Therefore, the ethanolic HPC-solution ink with either Tadalafil or rasagiline mesylate and the HPMC film that is not supposed to disintegrate during the printing process as taught by Janβen, is understood to read on the “orodispersible thin film printed with an ink comprising at least one active ingredient on its surface and is free from cavities” of claim 1 and the “orodispersible thin film that has printing on its surface with at least one active ingredient for oral delivery, and is free from cavities” of claim 5.
Janβen teaches that the thickness, disintegration time and mechanical properties of the ODFs were not affected by printing and that any slightly lower mechanical property was not relevant for handling (page 824 paragraph 2, page 822 paragraph 3). Janβen teaches that the combination of a HPMC-based drug-free film and an ethanolic ink with HPC enables the manufacturing of printed ODFs without film rupturing or crumbling during the process and without losing the fast dissolving properties of the ODFs, that the printed layer could not be separated from the film and that no loss of crystals or API is anticipated during packaging and storage due to the strong adherence of the ink to the ODFs (page 823 paragraph 1). As the printed API was able to secure tightly to the ODF and the film did not have a relevant loss in mechanical properties after printing, this is understood to read on the requirement of instant claims 1 and 5 of a film characterized in having a “porosity and absorptivity for the purpose of printing; and foldability and mechanical strength for the purpose of withstanding handling in the course of its manufacturing, packaging, storage, transportation and use.”
As discussed supra, the phrase in claims 1 and 5 of a “paper like surface roughness” is relative and may be interpreted by one of ordinary skill as encompassing surfaces that are smooth to rough. As evidenced by the instant specification, a paper like appearance is the requisite for active ingredient printing i.e. surface roughness, porosity, foldability, mechanical strength, absorptivity etc. (page 12 lines 1-3). As the film of Janβen is able to be successfully printed, it would be understood to have a paper like appearance and an appropriate surface roughness. Therefore, the ODF of Janβen is understood to read on the requirement of a “paper like surface roughness” in claims 1 and 5.
Response to Arguments
Applicant's arguments filed 25 Jun 2025 have been fully considered but they are not persuasive. The applicant appears to argue that the phrase “comprising” requires interpretation of the claim to be limited to only what is explicitly recited in the claim and that “whatever is not expressly claimed cannot be construed as anticipated by the applicant over any cited prior art.” The applicant then makes a distinction about the level of protection that would be afforded in a patent when “consisting of” instead of “comprising” is used and states that “comprising” is a better choice for their purpose (pages 15-16 of remarks).
The point of the argument by the applicant regarding the protection sought after with “comprising” verse “consisting of” is not entirely clear to the examiner. At this point the examiner merely reiterates that for purposes of examination that the phrase “comprising” is understood to be inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). The claims are open to additional elements such as a liner and the claims are maintained as anticipated by the teaching of Janβen for the reasons given above.
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 1-5, 7-9 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Janβen et al. (International Journal of Pharmaceutics 441 (2013) 818– 825) as evidenced by the instant specification in view of Patil et al. (IJSR Volume 3 Issue 7, July 2014) and Karavas et al. (WO 2016/015798 published 04 Feb 2016) .
The teachings of Janβen are described supra.
Regarding claim 2, Janβen additionally teaches that the tensile strength of the Rasagiline mesylate and Tadalafil ODF per the invention ranged from ~15.72-19.10 MPa (page 822 Table 1) which is equivalent to ~160 – 195 kg/cm2, and that the disintegration time ranged from ~22-46 seconds (page 824 Table 2), thus meeting the requirements of disintegration time and tensile strength of claim 2.
Janβen does not teach that the film has a folding endurance of a minimum of 8 times (claim 2) or that the film comprises polyethylene glycol or titanium dioxide (claim 4 and 17). These deficiencies are made up for in the teachings of Patil.
Patil teaches that fast dissolving oral films are a drug delivery system for the oral delivery of the drugs in an ultra thin film prepared using hydrophilic polymers that rapidly dissolves on the top or the floor of the tongue or buccal cavity (page 2088 col 1).
Regarding claim 2, Patil teaches that the typical folding endurance for film is between 100-150 (page 2091 7. Folding endurance). Patil additionally teaches that the typical disintegration time for film is 5-30 seconds (page 2091 7. Disintegration test). 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).
Regarding claims 4 and 17, Patil teaches that plasticizers in oral films enhance mechanical properties such as tensile strength and elongation to the film by reducing the glass transition temperature of the polymer and reduces brittleness of the strip and improves flexibility (page 2089 section 2.1.3). The choice of plasticizer depends upon the type of solvent used and its compatibility with the polymer and commonly employed plasticizers include low molecular weight polyethylene glycols (page 2089 section 2.1.3).
Regarding claims 4, 7-9, and 17, Patil additionally teaches that titanium dioxide is used as a prominent coloring agent for oral films (page 2089 section 2.1.7).
Karavas teaches an orodispersible film comprising Enalapril (abstract). Karavas teaches that fillers, such as titanium dioxide, may be added as a film component to reduce greasy features of the film in the mouth and endow a skeleton structure to the film and that the fillers may be in the range from 1 to 15% w/w of the film (page 7 lines 28-33). 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). The titanium dioxide of Patil and Karavas would necessarily act as an adsorbent and impart roughness to the surface of the film/substrate. "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. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Further, "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have formed an orodispersible thin film comprising HPMC, low molecular weight polyethylene glycol, and 1-15% w/w titanium dioxide because titanium dioxide reduces greasy features of the film in the mouth and endows a skeleton structure to the film as taught by Karavas, and wherein the film is formulated to have a folding endurance of 100-150 times, a disintegration time between 5 and 30 seconds as taught by Patil, and a tensile strength of ~160 – 195 kg/cm2 and printed with an ethanolic ink containing an active ingredient wherein the ink does not disintegrate (form cavities) in the film. Ethanolic inks containing active ingredients have been shown to successfully print on HPMC films without disintegrating or otherwise significantly affecting the mechanical properties, such as tensile strength, of the film by Janβen, thus making ethanolic inks and HPMC films an attractive option to one of ordinary skill. Additionally, low molecular weight polyethylene glycol and titanium dioxide (1-15% w/w) are common ingredients in films and the functional properties of a disintegration time between 5-30 seconds and a folding endurance of 100-150 times are taught as typical properties of films by Patil, thus providing one of ordinary skill in the art with a reasonable expectation of successfully forming a film with these components and claimed properties.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by
the references.
Response to Arguments
Applicant's arguments filed 06 Oct 2025 have been fully considered but they are not persuasive. The applicant argues that the film of Janβen has an intermediate liner as an essential element and that Janβen does not anticipate or render obvious as this feature is not named in claims 1 and 5. The examiner disagrees with the applicants position and again notes that the phrase “comprising” is understood to be inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). The claims are open to additional elements such as an intermediate liner and the claims are maintained as obvious from the teaching of Janβen for the reasons given above. The distinction made by the applicant regarding what are essential elements in the claim is not persuasive in overcoming the rejection. Each of the elements recited in the claims are obvious for the reasons described above and the fact that other elements unrecited are not considered essential for the invention by the applicant is not a sufficient reason to overcome the rejection. The applicant notes that claim 5 does not recite “comprising.” The examiner acknowledges that transitional phrases such as "has" must be interpreted in light of the specification to determine whether open or closed claim language is intended (See MPEP 2111.03(II)(IV). Claim 5 is directed merely to the substrate and not to the orodispersible thin film itself and the art meets the requirements of the substrate as noted in the rejection above. The specification does not indicate that a liner should excluded and there is not a clear reason to read the claim as closed to unrecited elements, similar to “consisting of.” Thus, the addition of a liner onto the substrate is understood to render obvious the instant claims.
The applicant asked for the examiner to review the final rejection from 18 Oct 2024 regarding the rejection of claim 8 and 9 (page 18 of remarks). As previously noted, claims 8 and 9 were rejected in the non-final from 09 May 2024 and the same rejection was applied in the final rejection on 18 Oct 2024. Upon review of the rejections, it is clear that claims 8 and 9 were properly rejected in the Final rejection of 18 Oct 2024. The applicant further asserts that the rejection of claims 8 and 9 is improper as the rejection ”is directed against recital of the single ingredient titanium dioxide (page 19 of remarks). The examiner notes that claims 8 and 9 only require titanium dioxide as the ingredient that imparts roughness. Thus, it is only necessary to address titanium dioxide as the required ingredient in the rejection.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600