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
This action is in response to papers filed February 4, 2026. Applicant’s reply to the restriction/election requirement of December 4, 2025 has been entered. Claims 2, 4, 5, 7-11, 13, 15, 16, 18, 19, 25-27, 30, 33-37, and 45-47 have been amended; and claims 6, 12, 14, 21-24, 29, 31, 32, 38-44, and 48 have been canceled. Claims 1-5, 7-11, 13, 15-20, 25-28, 30, 33-37, and 45-47 are pending in the application.
Priority
Acknowledgment is made of Applicant's claim for foreign priority based on Indian Patent Application No. 202211043456, filed in the Republic of India on July 29, 2022. It is noted, however, that Applicant has not filed a certified copy of the above cited Indian Patent application as required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election of Group I, claims 1-5, 7-11, 13, 15-20, 25-28, 30, 33-36, and 46, is acknowledged. Applicant’s elections of i) “Kyron 114” as the species of ion exchange resin, ii) “bitter masking agent” as the species of further constituent, iii) “mannitol” as the species of diluent, iv) “crospovidone” as the species of disintegrant, v) “peppermint flavor” as the species of flavoring agent, vi) “aspartame” as the species of sweetener, vii) “sodium stearyl fumarate” as the species of lubricant, viii) “2 years, 25-30C, and 60-75% humidity” as the species of stability period, ix) “direct compression” as the species of means of forming the tablet are all also acknowledged. The Examiner has determined that claims 1-5, 7-11, 13, 33-36, and 46 read on the elected subject matter.
Accordingly, claims 15-20, 25-28, 30, 37, 45, and 47 are hereby withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected subject matter, there being no allowable generic or linking claim. Applicant expressly stated that the species elections are made without traverse. However, because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, i.e. between Groups I-III, the election of Group I has also been treated as an election without traverse (MPEP § 818.01(a)).
Election was made without traverse in the reply filed on February 4, 2026. Claims 1-5, 7-11, 13, 33-36, and 46 are currently under examination.
Abstract
The abstract of the disclosure is objected to because of the following:
1. The abstract should be a concise summary of the key technical aspects of the invention which are new to the art to which the invention pertains. If the invention is a composition, the abstract should recite the key requisite ingredients. If the invention is a method, the abstract should recite the key requisite active steps.
2. The abstract merely informs the reader about palatable ODTs comprising drotaverine. These are not new to the art. Nor does the abstract properly inform the reader about the key technical aspects of the invention. At the very least, the abstract should disclose ODTs containing a drotaverine-ion exchange resin complex, in which the ion exchange resin is Kyron or Indion.
3. Moreover, the abstract introduces “methods” but does not recite the key requisite active steps.
4. There should be a comma between “palatable” and “orally disintegrating”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1, 4, 5, 8, 9, and 46 are objected to because of the following:
i). In claims 1, 4, 5, and 8, the term “drotaverine” should not be capitalized.
ii). In claim 1, there should be a comma between “a salt thereof” and “and an ion exchange resin”, and there should be a semicolon rather than a comma between “ion exchange resin” and “wherein”.
iii). In claim 1, both expressions “ion exchange resin” and “ion-exchange resin” are used. Applicant should decide if they want to employ the hyphen or not, and be consistent.
iv) In claim 9, the expression “around 850 microns to 300 microns” is in improper format. Applicant is advised to amend the expression to e.g. “300 microns to 850 microns”.
v). In claim 46, the preamble, i.e. “The dosage form of claim 1” is inconsistent with the preamble employed for the other claims, which is directed to “The oral dosage form”. Applicant is advised to maintain a consistent preamble.
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, 3, 8, 9, and 33-36 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 stipulates in a wherein clause that “the dosage form further comprises a taste enhancer”. The chemical compound or compounds that fall within the purview of “a taste enhancer” are not defined by the claim. Nor is the baseline or reference “taste” to which “a taste enhancer” is relative to. A “taste” is really nothing more than an abstract mental sensation. Hence, a “taste enhancer” is a relative, arbitrary and subjective criterion. What may be a “taste enhancer” for one subject in one context may not be for another subject, or even for the same subject in a different context. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 8 stipulates in a wherein clause that “the ratio of drotaverine to ion-exchange resin is 1:2 to 1:6”. The parameter for which the ratio is based is not defined by the claim. One of ordinary skill in the art cannot thus definitively ascertain whether the “ratio” is a weight ratio, a molar ratio, a volume ratio, or some other ratio. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 9 stipulates in a wherein clause that “the size of the granules is in the range of around 850 microns to 300 microns”. One of ordinary skill in the art cannot make heads or tails out of “around” the specified range of 850 microns to 300 microns. For example, is 900 microns included in this “around” the specified range? How about 200 microns?
Claim 33 stipulates that the dosage form is “stable” for 2 years when stored under the recited temperature and humidity conditions. The term “stable” is not defined by the claim. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “stable”. Does “stable” mean that the dosage form does not explode? Does stable mean the dosage form does not get contaminated with bacteria? Does stable mean that 100% of the drotaverine present at the start of the 2-year storage period is still present after the 2-year storage period? Or what?
Claims 34, 35, and 36 stipulate in a wherein clause that the dosage form exhibits “improved taste”, “improved aftertaste”, and “improved palatability”, respectively. Indeed, “taste”, “aftertaste” and “palatability” are really nothing more than abstract mental sensations, and thus are arbitrary and subjective criteria. Moreover, the term “improved” is relative, arbitrary, and subjective as well, and the baseline or reference “taste”, “aftertaste”, and “palatability” is not defined. One of ordinary skill in the art thus cannot definitively ascertain the metes and bounds of the claimed subject matter.
Claim 3 is indefinite for depending from an indefinite claim.
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 1-5, 7-11, 13, 33-36, and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Kuralla et al. (J Applied Pharm Sci. 2018; 8(10): 39-46), in view of Pilgaonkar et al. (U.S. Patent Application Pub. No. 2010/0215740), and Sikandar et al. (Eur. J. Biol. Sci. 2011; 3(3): 67-71).
Applicant Claims
Applicant’s elected subject matter is directed to an orally disintegrating tablet comprising a drotaverine-Kyron 114 complex and a bitter taste masking agent; wherein the drotaverine is present in the tablet in the amount of 2.5-100 mg, wherein the drotaverine to Kyron 114 “ratio” is 1:2 to 1:6, and wherein the tablet comprises granules 300-850 microns in size and has a hardness of 3-12 kp.
**Kyron 114 is a copolymer of methacrylic acid crosslinked with divinylbenzene.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Kuralla et al. disclose an orally disintegrating tablet comprising drotaverine (i.e. a bitter active) and a bitter taste masking agent; wherein the drotaverine is present in the tablet in the amount of 40 mg; and wherein the tablet comprises granules less than 600 microns in size, is formed by direct compression, and exhibits good mechanical strength and disintegrates in the mouth in less than 60 seconds.
Pilgaonkar et al. disclose an orally disintegrating tablet comprising a bitter active-cation exchange resin complex and a bitter taste masking agent (e.g. peppermint flavor); wherein the cation exchange resin can be e.g. a copolymer of methacrylic acid crosslinked with divinylbenzene; wherein the bitter active to ion exchange resin “ratio” is e.g. 1:2; and wherein the tablet comprises granules and is directly compressed, has a hardness of e.g. 20-40 N (i.e. 2-4 kp), and has a disintegration time of e.g. 8-12 seconds (abstract; paragraphs 0012, 0013, 0016, 0022, 0029, 0032-0034, 0045, 0047, Examples).
Sikandar et al. disclose that taste masking of bitter actives can be successfully accomplished by forming a bitter active-cation exchange resin complex with Kyron 114, a cation exchange resin that is a copolymer of methacrylic acid crosslinked with divinylbenzene; wherein the bitter active to Kyron 114 ratio is 1:2 to 1:3.
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Kuralla et al. do not explicitly disclose that the drotaverine (i.e. a bitter active) is in a complex with the cation exchange resin Kyron 114; wherein the drotaverine to Kyron 114 “ratio” is 1:2 to 1:6. These deficiencies are cured by the teachings of Pilgaonkar et al. and Sikandar et al.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to combine the respective teachings of Kuralla et al., Pilgaonkar et al. and Sikandar et al., outlined supra, to devise Applicant’s presently claimed orally-disintegrating tablet.
Kuralla et al. disclose an orally disintegrating tablet comprising drotaverine (i.e. a bitter active) and a bitter taste masking agent; wherein the drotaverine is present in the tablet in the amount of 40 mg; and wherein the tablet comprises granules less than 600 microns in size, is formed by direct compression, exhibits good mechanical strength, and disintegrates in the mouth in less than 60 seconds. Since Pilgaonkar et al. disclose that in an orally disintegrating tablet, a bitter active can be complexed with a cation exchange resin; wherein the cation exchange resin can be e.g. a copolymer of methacrylic acid crosslinked with divinylbenzene, and the bitter active to ion exchange resin “ratio” is e.g. 1:2; successfully masks the bitter taste of the active and has a disintegration time of e.g. 8-12 seconds; and since Sikandar et al. disclose that taste masking of bitter actives can be successfully accomplished by forming a bitter active-cation exchange resin complex specifically with Kyron 114, a cation exchange resin that is a copolymer of methacrylic acid crosslinked with divinylbenzene; wherein the bitter active to Kyron 114 ratio is 1:2 to 1:3, and that this measure for taste masking can be combined with other measures for taste masking, such as peppermint flavoring and granulation; one of ordinary skill in the art would thus be motivated to employ a drotaverine-Kyron 114 complex together with a bitter taste masking agent in the Kuralla et al. orally-disintegrating tablet; wherein the drotaverine to Kyron 114 “ratio” is e.g. 1:2 to 1:3, with the reasonable expectation that the resulting tablet will exhibit good mechanical strength, disintegrate in the mouth in less than 60 seconds, and successfully mask the bitter taste of drotaverine for better patient compliance.
One of ordinary skill in the art, in view of the cited prior art, would thus arrive at the claimed orally-disintegrating tablet. Since the tablet is the same (or at least not patentably distinct), the properties must be the same as well.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the 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 references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617