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 .
provisions of the AIA .
DETAILED ACTION
Priority and Status of Claims
1. This application claims benefit of the foreign application:
INDIA IN202211043457 with a filing date 07/29/2022. However, the certified foreign priority document has not been filed to the Office. Applicants are requested to file the document to the Office to obtain the foreign priority.
2. Claims 1-11, 13, 16, 18-19, 21, 24-26, 28, 30, 33-38 and 44 are pending in the application.
Claim Rejections - 35 USC § 112
3. 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.
Claims 4-5 and 28 is 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 pre-AIA the applicant regards as the invention.
Claims 4-5 and 28 independently contain the trademark/trade name “Povidone”, “Kollidon 12 PF”, “Kyron 314”, “Indion 204”, “Indion 234”, “Indion 294” and “Kyron 114”, see lines 2 and 5 in claim 28. 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 metaxalone, accordingly, the identification/description is indefinite. Incorporation of original chemical names of above trade names would obviate the rejection.
4. 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.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 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(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-11, 13, 16, 18-19, 21, 24-26, 28, 30, 33-38 and 44 are rejected under
35 U.S.C. 103(a) as being obvious over Badabhagni et al. US 2014/0080864 A1.
Applicants claim an oral suspension comprising Drotaverine or a salt thereof, wherein the Drotaverine or salt thereof is in a concentration of greater than 4 mg/mL, see claim 1.
Dependent claims 2-11, 13, 16, 18-19, 21, 24-26, 30, 33-36 and 44 further limit the
scope of compositions, i.e., specific amount or salt of Drotaverine including
hydrochloride, resin including Kyron 114, carboxymethylcellulose or gum, and
methods of use for treating pain.
Applicants claim an oral suspension comprising Drotaverine hydrochloride, Kyron114, Simethicone, Xanthan gum, Povidone (Kollidon 12 PF), Sucrose, Citric acid, Tween-80, Sodium metabisulphite, Sorbitol 70%, glycerin, Methyl Paraben, Propyl Paraben, and a flavoring agent, wherein the Drotaverine hydrochloride and Kyron 114 comprise a drug-resin complex, and wherein the Drotaverine hydrochloride and Kyron 114 are in a 1:3 ratio, see claim 28.
Applicants claim a method of preparing an oral suspension of Drotaverine or salt thereof comprising:
a. heating a quantity of water and adding at least one preservative and milled sucrose, stirring the resulting mixture continuously until dissolved to obtain a solution;
b. cooling the solution to obtain a cooled solution;
c. adding at least one acidifier and at least one antioxidant into the cooled solution until dissolved to obtain a solution;
d. adding at least one wetting agent into the solution until dissolved to obtain a solution;
e. adding at least one stabilizer and a dispersion that has been obtained by soaking at least one suspending agent in water, until dissolved to obtain a bulk solution;
f. sifting a drug-resin complex comprising Drotaverine or a salt thereof through a sieve, adding the bulk solution obtained in step (e), and stirring until dissolved to obtain a bulk suspension; and
g. adding a quantity of water to the bulk suspension to obtain a suspension of Drotaverine or a salt thereof, see claim 37. Dependent claim 38 further limit the scope of processes, i.e., adding simethicone.
Determination of the scope and content of the prior art (MPEP §2141
Badabhagni et al. ‘864 discloses a pharmaceutical composition for oral administration comprising: 5 to 30% (w/w) of drotaverine hydrochloride; and at least 60% (w/w) of a liquid mixture of at least one non-ionic hydrophilic surfactant and at least one non-ionic hydrophobic surfactant or resin. Badabhagni et al. ‘864 also discloses a method for preparing a pharmaceutical preparation according to claim 1, comprising the following successive steps: dissolving the drotaverine hydrochloride in the liquid mixture of at least one non-ionic hydrophilic surfactant and at least one non-ionic hydrophobic surfactant, with stirring, in order to obtain a homogeneous mixture; and then adjusting the pH between 4-6 using a conventional buffer. Badabhagni et al. ‘864 compositions are used for treating pain, see claims 1, 13 and 14 in column 6.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Badabhagni et al. ‘864 is that the instant claims are embraced within the scope of Badabhagni et al. ‘864. Badabhagni et al. ‘864 read on the instant compositions of claims 1 and 28, and indirectly processes of making of claim 0 37, and dependent claims 2-11, 13, 16, 18-19, 21, 24-26, 30, 33-36 and 44.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-11, 13, 16, 18-19, 21, 24-26, 28, 30, 33-38 and 44 prima facie obvious because one would be motivated to employ the compositions of Badabhagni et al. ‘864 to obtain instant invention.
Moreover, the amount of a specific amount of ingredient drotaverine of the instant composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize, optimization of parameters (dose, administration strategy) from known compositions and methods of use of Badabhagni et al. ‘864 is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results based on factors such as the severity of the condition being treated for treating depression, see MPEP 2144.05. Therefore Badabhagni et al. ‘864 renders obviousness over the instant invention.
The motivation to make the claimed compositions, processes of making, and methods of use derived from the known compositions, processes and methods of use of Badabhagni et al. ‘864 would possess similar activity to that which is claimed in the reference.
Double Patenting
6. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 is provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Berlia et al. co-pending application No. 18/361,142. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim an oral suspension comprising Drotaverine or a salt thereof, wherein the Drotaverine or salt thereof is in a concentration of greater than 4 mg/mL, see claim 1.
Berlia et al. ‘142 claims an oral dosage form comprising Drotaverine or a salt thereof and an ion exchange resin, wherein Drotaverine and the ion-exchange resin comprise a Drotaverine-ion-exchange complex, and wherein the dosage form is formulated as an orally disintegrating tablet, see claim 1.
The difference between instant claims and Berlia et al. ‘142 is that the instant claims are embraced within on the scope of Berlia et al. ‘142.
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ the compositions and methods of use of Berlia et al. ‘142 to obtain instant invention. It is noted that a choice formulation of tablet or suspension is a routine alternative in the pharmaceutical science industry.
The motivation to make the claimed compositions from the known compositions of Berlia et al. ‘142 would possess similar activity to that which is claimed in the reference.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REI TSANG SHIAO whose telephone number is (571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
December 12 2025