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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
“Comprising of:” should read “comprising:”
Immediately following “sucrose”, “silicified microcrystalline cellulose”, “hydroxypropyl beta-cyclodextrin”, “ammonium glycyrrhizinate”, “xylitol”, “hydroxyl propyl methyl cellulose”, “glycerol”, “flavor”, “cooling agent flavor”, “sodium carbonate”, “citric acid”, and “color”, “at” should be included.
The dash immediately following sucralose in “sucralose – 0.33% - 4%” should be removed.
The names of the individual components, e.g., “Sucrose”, etc., should be lower case.
Appropriate correction is required.
Claim 2 is objected to because of the following informalities: “betacyclodextrin” should read “beta-cyclodextrin” in order to be consistent with the terminology used in claim 1.
Claims 2-10 are objected to because of the following informalities: claims 2-10 recite “by total weight” and should read “by total weight of the composition” in order to be consistent with the terminology of claim 1. Appropriate correction is required.
Claims 3-7, 9, and 10, are objected to because of the following informalities: claims 3-7, 9, and 10 are missing “the” following “wherein”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: “flavoring agent whose” should read “wherein the flavoring agent whose”, in order to be consistent with the terminology used in the other dependent claims. 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 1-10 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 1 recites an orally disintegrating film comprising the components of a) and the excipients b), and it is unclear where the components of a) appear to read on the excipients of b), as defined by the dependent claims, if the excipients of b) are additional components or if b) is an alternative embodiment. For example, silicified microcrystalline cellulose at 1-20 wt% appears to read on the disintegrating agents of b) as evidenced by claim 5. Adding to the lack of clarity of claim 1 are the dependent claims, which recite the terminology of the excipients of b) (e.g., solubilizer, plasticizer, etc.), but also recite the concentration ranges of the individual components from a). For purposes of examination, the claim is interpreted as requiring a) or b), and the components of a) are interpreted to read on the excipients of b), as defined by the dependent claims.
Claim 2 recites the trademark/trade name “KOLLIPHOR RH 40”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a particular product and, accordingly, the identification/description is indefinite.
Claim 2 recites the limitation "wherein the solubilizer whose concentration ranges from 0.1% - 10%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as “solubilizer” with a concentration defined as having a range from 0.1% - 10%.
Claim 3 recites the limitation "wherein polymer whose concentration ranges from 10% - 25%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “polymer” with a concentration defined as having a range from 0.1% - 10%.
Claim 4 recites the limitation "wherein plasticizer whose concentration ranges from 0.1% - 10%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “plasticizer” with a concentration defined as having a range from 0.1% - 10%.
Claim 5 recites the limitation "wherein disintegrating agent whose concentration ranges from 1% - 20%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “disintegrating agent” with a concentration defined as having a range from 1% - 20%.
Claim 6 recites the limitation "wherein sweetening agent whose concentration ranges from 0.33% - 4%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “sweetening agent” with a concentration defined as having a range from 0.33% - 4%.
Claim 7 recites the limitation "wherein cooling agent whose concentration ranges from 2.5% - 10%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “cooling agent” with a concentration defined as having a range from 2.5% - 10%.
Claim 8 recites the limitation "flavoring agent whose concentration ranges from 2.5% - 10%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “flavoring agent” with a concentration defined as having a range from 2.5% - 10%.
Claim 9 recites the limitation "wherein pH modulating agent whose concentration ranges from 0.05% - 5%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “pH modulating agent” with a concentration defined as having a range from 0.05% - 5%.
Claim 10 recites the limitation "wherein coloring agent whose concentration ranges from 0.001% - 0.1%" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claim depends from claim 1, where there is no component recited as a “pH modulating agent” with a concentration defined as having a range from 0.001% - 0.1%.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
Claim 2 recites the broad recitation “polyoxyethylene castor oil derivatives”, and the claim also recites “(kolliphor RH 40)" which is the narrower statement of the range/limitation.
Claim 7 recites the broad recitation “cooling flavour”, and the claim also recites “(menthol)” which is the narrower statement of the range/limitation.
Claim 9 recites the broad recitation “amino acids”, and the claim also recites “such as aspartic acid, glutamic acid, glycine, leucine, tyrosine, and tryptophan” which is the narrower statement of the range/limitation.
Claim 10 recites the broad recitation “pigments and opacifying agents”, and the claim also recites “such as titanium oxide, silicon dioxide and zinc oxide” which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Rangabhatla (WO2019202521 A1), in view of Reddy (J Pharm Sci and Res, 2020, vol 12(7), pp. 925-940), as evidenced by Industry Plaza (Silicified Microcrystalline Cellulose: Prosolv®, pp. 1-6, retrieved 2025).
Rangabhatla discloses an oral disintegrating film composition comprising:
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. As evidenced by Industry Plaza, PROSOLV ODT G2 comprises the combination microcrystalline cellulose and colloidal silicon dioxide, which is disclosed as silicified microcrystalline cellulose. Cooling flavors include peppermint flavor, menthol, flavor oils, flavoring aromatic oil, peppermint oil, clove oil, bay oil, anise oil, eucalyptus oil thyme oil, and oil of bitter almonds (pg. 11 3rd ¶). Paracetamol is a non-steroidal anti-inflammatory drug (pg. 1 last ¶).
Rangabhatla does not teach ketorolac nor its wt% as instantly claimed.
Reddy teaches fast dissolving oral thin film drug delivery systems comprising:
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(introduction, table 1). Suitable active pharmaceutical ingredients for incorporation into the thin films include ketorolac, a non-steroidal anti-inflammatory drug (NSAID) (table 2). The saliva stimulating agents include citric acid, etc. (pg. 932 1st ¶). Flavoring agents include mint, vanilla, etc. (table 15).
Regarding ketorolac of claim 1, it would have been obvious to modify the oral disintegrating film of Rangabhatla by substituting ketorolac for paracetamol, where ketorolac is taught by Reddy as suitable for oral film formulations comprising similar components with overlapping concentrations, and where ketorolac and paracetamol are both non-steroidal anti-inflammatory drugs. See MPEP 2143(I)(B).
Regarding the wt% of ketorolac of claim 1, it would have been obvious to include ketorolac in known amounts suitable for oral disintegrating film formulations, such as from 5-30 wt%, as taught by Reddy, overlapping the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding the components and their amounts of claim 1, the orally disintegrating film composition made above comprises the same components instantly claimed, and in the same amounts instantly claimed.
Regarding claim 2, the orally disintegrating film composition made obvious above comprises hydroxypropyl beta-cyclodextrin in the claimed amounts.
Regarding claim 3, the orally disintegrating film composition made obvious above comprises hydroxylpropyl methylcellulose in the claimed amounts.
Regarding claim 4, the orally disintegrating film composition made obvious above comprises glycerol in the claimed amounts.
Regarding claim 5, the orally disintegrating film composition made obvious above comprises Prosolv ODT G2 in the claimed amounts, which comprises silicified microcrystalline cellulose.
Regarding claim 6, the orally disintegrating film composition made obvious above comprises sucralose and xylitol in the claimed amounts.
Regarding claim 7, it would have been obvious to include peppermint flavor, cooling flavors such as menthol, flavor oils, flavoring aromatic oil, peppermint oil, clove oil, bay oil, anise oil, eucalyptus oil thyme oil, and/or oil of bitter almonds as the cooling agent flavor in the claimed amounts, as taught by Rangabhatla.
Regarding claim 8, the orally disintegrating film composition made obvious above comprises chocolate flavor in the claimed amounts.
Regarding claim 9, the orally disintegrating film composition made obvious above comprises sodium carbonate and citric acid in the claimed amounts.
Regarding claim 10, the orally disintegrating film composition made obvious above comprises solid choco color in the claimed amounts.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,202,756 B2, hereinafter ‘756, in view of Reddy (J Pharm Sci and Res, 2020, vol 12(7), pp. 925-940). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘756 disclose a fast dissolving film composition comprising paracetamol, a solubilizer selected from hydroxypropyl beta-cyclodextrin, etc., a disintegrant selected from silicified microcrystalline cellulose, etc., and taste masking agent as a mixture of sodium carbonate, citric acid, and magnesium aluminometasilicate (claim 1). The composition further comprises a polymer selected from hydroxypropyl methylcellulose, etc. (claim 4), sweetening agents selected from sucralose, xylitol, etc. (claim 6), a plasticizer selected from glycerol, etc. (claim 5). A particular embodiment is disclosed in claim 10 with the amounts of excipients that overlap the claimed ranges.
The claims of ‘756 do not disclose ketorolac nor its amounts.
Reddy is discussed above.
It would have been obvious to modify the composition of ‘756 by substituting ketorolac for paracetamol, and in known amounts suitable for fast dissolving film compositions, for the same reasons discussed above by Reddy.
Regarding the excipients of a), it would have been obvious to select among the suitable excipients disclosed by ‘756, in the claimed amounts, thereby arriving at the instantly claimed invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA A ATKINSON whose telephone number is (571)270-0877. The examiner can normally be reached M-F: 9:00 AM - 5:00 PM + Flex.
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/JOSHUA A ATKINSON/
Examiner, Art Unit 1612
/MARIANNE C SEIDEL/Primary Examiner, Art Unit 1600