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
Claims 1-19 are currently pending and a preliminary amendment to the claims filed on 06/04/2026 are acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, claims 1-14 in the Reply filed on 06/04/2026 is acknowledged. By way of applicant’s election, claims 15-19 have been withdrawn from further consideration. Since the election was made without traverse, the requirement is still deemed proper and is therefore made FINAL
Therefore, claims 1-14 are examined on the merits to which the following grounds of rejections are applicable.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/18/2024 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
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 2, 4-6, 12 and 14 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.
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, each of claims 2, 4, 5 and 10 recites the broad recitations, i.e., “at least 60% (claim 2), thiosulphate salt (claim 4), pH sensitive methacrylic acid and carbomer (claim 5), administration (claim 12)”, and the claim also recites, i.e., “at least 65% (claim 2), sodium thiosulphate (STS, claim 4), amounts of pH-sensitive methacrylic acid-methyl methacrylate copolymer and carbomer (claim 5), and oral dosage form of administration (claim 12) are 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.
Further, claim 6 recites “high-molecular weight (Mw) polyacrylic acid…”, but it is not clear because “high” is subjective and relative term and can vary across different polyacrylic acid classes, and the specification also does not disclose the definition of such Mw and thus, the ordinary artisan cannot determine the boundaries of claim 6. Thus, claim 6 is indefinite.
Claim 14 recites “(chronic) kidney disease”, but it is not clear whether the part covered by parenthesis is limitation or not. This is because the term “chronic” is a subset of kidney issues that includes “acute”. Thus, claim 14 is not clear.
Appropriate correction is requested.
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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Badoni et al., “A research article on formulation and evaluation of enteric coated tablet loaded with rabenprazole for mucoadhesive drug delivery”, The Pharma Innovation, vol. 1, no. 8, 2012 , pp. 50-58 (IDS of 07/18/2024) in view of Naiserová et al., “(Meth)acrylate copolymers of Eudragit® type in oral tablet technology”, Čes. slov. Farm. 2019; 68, 183–197 and Gallardo et al., “Controlled release solid dosage forms using combinations of (meth)acrylate copolymers”, Pharm Dev Technol., 2008; 13(5): 413-23, and further in view of Gordon et al. (US2010/0105717A1).
Applicant claims the below claim 1 filed on 06/04/2026:
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For examination purpose, instant claims 11-14 are intended uses of the claimed pharmaceutical oral dosage form, which merely defines a context in which the invention operates. see Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Moreover, the patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002). Thus, "recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1977). The recited intended uses do not structurally define the claimed composition because the mere recitation of an inherent property (intended use) does not render one claim patentable over the other. Applicant is merely multiplying the number of claims. Thus, the intended uses do not define different inventions. “It was held by the Patent Office tribunals, on the authority of In re Thuau, 135 F.2d 344, 30 C.C.P.A., Patents, 979, that the addition of a statement of use to a claim to a compound does not produce a materially different claim. Therefore, instant claims 11-14 do not structurally define the claimed invention, and thus, if the prior art teaches the claimed composition, such intended uses of the composition would be implicit from the prior art composition.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Badoni discloses delayed oral dosage form tablet prepared by wet granulation method using rabeprazole that is a substituted benzimidazole and acid labile, here, rabeprazole reads on the claimed therapeutically active acid-labile salt, carbopol reads on the claimed carbomer that is high-molecular weight polyacrylic acid crosslinked with alkyl pentaerythritol as supported by the instant publication at [0028]-[0029], HPMC polymer, and excipients etc. (e.g., abstract and Table 1), and thus, the prepared tablet reads on the claimed core; the core were further coated using enteric coating polymer such as HPMC-P which reads on the claimed enteric coating, and that is, the enteric coating contains HPMC-P polymer, titanium dioxide, diethyl phthalate, acetone, isopropyl alcohol (see e.g., section 2.24 on page 52); in embodiment, 100mg tablet contains 10% rabeprazole, 20-60% carbopol that overlaps the instant range of 5-30%, talc, etc. (e.g., abstract and Tables 1-2 on page 52 and section 4.5 on page 54); and the enteric coated tablet of rabeprazole releases at pH 7.2, and that is, such enteric coated tablets are capable of exhibiting sustained release properties for a period of at least 12h at a pH of 7.2 and do not release the drug for a period of 2h at an acidic pH=1.2, and in other words, the drug is not released at all in acid (first 120 minutes), and at pH 6.8, a slow release is made over a period of more than 2 hours and higher concentration of Carbopol showed better sustained release properties than HPMC as the polymer (see e.g., section 4.5 on page 54 and Table 6 on page 55)(instant claims 1 and 5 (in part), instant claims 3 and 6).
However, Badoni does not expressly teach a pH-sensitive hydrophilic methacrylic acid-methyl methacrylate copolymer of instant claims 1, 2, and 5-10. The deficiencies are cured by Naiserová, Gallardo and Gordon.
Naiserová discloses (Meth)acrylate copolymers of Eudragit® type in oral tablet technology (title); Eudragit® copolymers are divided into soluble ones, insoluble ones and a combination of these two types, wherein the soluble pH-dependent poly(meth)acrylates (Eudragit® E, L, S, FS) exhibit a certain solubility in digestive fluids by salt formation. These polymers have acidic or alkaline groups which enable a pH- dependent release of the API (Active Pharmaceutical Ingredient). They are applied in taste masking, enteric formulations as well as in controlled drug release in all sections of the intestine. Namely, Eudragit® L and S are suitable for enteric coating (e.g., page 184, right column); in particular, due to the presence of enterosoluble carboxylic groups, Eudragit® L, S, and FS are anionic pH-dependent polymers suitable for gastro-resistant formulations) (Table 1). These polymers are soluble at pH above 5.5 (instant claims 8-9). Although dissolution of pH is mainly determined by the percentage of methacrylic acid, the presence of ester comonomers also contributes. As coating polymers, they ensure the site-specific drug release in the gastrointestinal tract (GIT), enabling the targeting to specific enteric areas, such as the upper intestine, the ileum, and the colon (page 185, left column and Table 1). Eudragits® display good reproducibility and other advantages associated with synthetic polymers. Further, these are regarded as non-biodegradable, non-absorbable, and non-toxic functional excipients, thus circumventing issues accompanying synthetic polymers (page 194, see conclusion).
Gallardo discloses controlled release solid oral dosage form enables drugs to be administered more comfortably while at the same time providing a sustained and reproducible method of release, and (meth)acrylate copolymers are one of the options available when considering a sustained release solid form, and the electrical character of these copolymers and their pH-dependent solubility can result in new and modified patterns when these polymers are combined (abstract); and the examples of (meth)acrylate copolymers include pH-dependent anionic polymers such as EUDRAGIT ® L, EUDRAGIT ®S and EUDRAGIT® FS are mainly used in gastro-resistant dosage forms (page 413, right column); the Eudragit ® L includes L100 and S100 and L100 consists of poly(methacrylic acid-co-methyl methacrylate) 1:1 and S100 consists of poly(methacrylic acid-co-methyl methacrylate) 1:2 (Table 1 on pate 414. For example, as pH-dependent methacrylate polymers Eudragit S 100 starts to dissolve at pH 7.0 and Eudragit L100-55 at pH 5.5 (page 418, right column), which means pH-dependent methacryate polymers release the drug at a pH above 5.0.
Gordon discloses an extended release oral dosage form comprising a core containing an active agent (e.g., tacrolimus or its derivatives) and/or sodium thiosulphate which reads on the claimed thiosulphate salt in a polymer matrix and an enteric coating (e.g., [0068], [0134], [0230], [0232]) (instant claim 4) wherein the amount of tacrolimus ranges up to 85% (e.g., [0089]); and the dosage form is solid dispersion prepared by dissolving a physical mixture of active substance and the carrier in a common solvent, followed by evaporation of the solvent and the carrier polymers containing acidic functional groups include methacrylic acid copolymer (Eudragit L, Eudragit S) ([0163]); the delay time before release of tacrolimus, after the “pH-dependent coated tablet” dosage form has exited the stomach, may be controlled by choice of the relative amounts of Eudragit-L® and Eudragit-S® in the coating, and by choice of the coating thickness, and Eudragit-L® films dissolve above pH 6.0, and Eudragit-S® films dissolve above 7.0, and mixtures dissolve at intermediate pH's. Since the pH of the duodenum is approximately 6.0 and the pH of the colon is approximately 7.0, coatings composed of mixtures of Eudragit-L® and Eudragit-S® provide protection of the duodenum from tacrolimus. If it is desired to delay release of tacrolimus until the tacrolimus-containing “pH-dependent coated tablet” has reached the colon, Eudragit-S® may be used as the coating material, as described by Dew et al. (Br. J. Clin. Pharmac. 14 (1982) 405-408). In order to delay the release of tacrolimus for about 15 minutes or more, preferably 30 minutes or more, after the dosage form has exited the stomach, preferred coatings comprise from about 9:1 to about 1:9 Eudragit-L®/Eudragit-S®, more preferably from about 9:1 to about 1:4 Eudragit-L®/Eudragit-S®. The coating may comprise from about 3% to about 70% of the weight of the uncoated tablet core. Preferably, the coating comprises from about 5% to about 50% of the weight of the tablet core ([0242]) which overlaps the instant range of 5-30% (instant claim 5).
It would have been obvious to modify the teachings of Badoni with addition of pH-sensitive methacrylic acid-methyl methacrylate copolymer (Eudragit L, S or FS) of Gallardo/Gordon because Badoni teaches core containing active agent in a polymer such as carbopol for the sustained release and enteric coating; and Gallardo/Gordon teach benefits of using pH-sensitive methacryate polymer Eudragit L or S; and Gordon teaches the core containing active ingredient in a polymer matrix such as pH-sensitive polymer including Eudragit L or S, and therefore, the combination of those references would enhance the controlled release of the drug as taught by the applied art. In this context, please see MPEP 2144.06 stating that “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
It would have been obvious to modify the teachings of the applied art with active agent thiosulfate salt of Gordon as a matter of choice or design of active agent because the applied references have the same purpose of providing improved controlled release polymer, and therefore selecting any acid labile salt active agents would be obvious variation. Further, Gordon teaches overlapping amounts of up to 80% of active agent and 5-50% of pH-sensitive polymers, and Badoni teaches 20-60% carbomer, and therefore, the claimed amount of active agent/polymers would be optimized or increased depending on the intended purpose, severity of condition, patient sex, weight, age, etc. (instant claim 2), and in particular, the ratio of pH sensitive methacrylate copolymer to carbomer would be optimized because Badoni teaches 20-60% carbomer and Gordon teaches coating about 5%-about 50%, in the absence of criticality evidence of the claimed range (instant claim 7). Please see MPEP 2144.05 (II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
Although the applied art alone or in combination does not expressly teach release profiles of instant claim 10, it would be implicit because the applied art in combination would achieve the claimed composition. Badoni discloses enteric coated tablets are capable of exhibiting sustained release properties for a period of at least 12h at a pH of 7.2 and do not release the drug for a period of 2h at an acidic pH=1.2, and in other words, the drug is not released at all in acid (first 120 minutes), and at pH 6.8, a slow release is made over a period of more than 2 hours and higher concentration of Carbopol showed better sustained release properties than HPMC as the polymer; Gallardo discloses (meth)acrylate copolymers are one of the options available when considering a sustained release solid form, and Naiserová and Gallardo disclose the Eudragit polymers are soluble at pH above 5.5. Thus, the claimed release profiles are natural results of the combination of prior art. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). See also MPEP 2112.01 (instant claim 10).
Regarding instant claims 11-14, as noted above, they are directed to a product, not a method of use. They merely recite intended uses of the product, not limiting the product. Since the applied art teaches the claimed product and thus, such claimed intended uses would be implicit (instant claims 11-14).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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