DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission, filed 02/20/2026, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 02/20/2026, is acknowledged.
Claims 1, 4-5, 7, 9-17, 19, 21-23 are pending in this action. Claims 2, 18, 20 have been cancelled. Claims 3, 6, 8 have been cancelled previously. Claims 1, 5, 13, 17, 19, 21 have been amended. Claims 1, 4-5, 7, 9-17, 19, 21-23 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application, filed March 11, 2025, is a continuation of PCT/IB2023/062817, filed December 15, 2023, which claims benefit of foreign priority to IN202221073257, filed December 17, 2022. International application WO 2024/127365) published under the Patent Cooperation Treaty (PCT/IB2023/062817) has been retrieved from WIPO/PCT.
Claim Objections
Claims 7, 9, 19 are objected to because of the following informalities:
Claim 7 comprises the typographic error “the duloxetine hydrochloride” that needs to be corrected to “duloxetine hydrochloride”. Similar is applied to claim 19.
Claim 9 comprises the typographic error “the hydroxypropyl methylcellulose” that needs to be corrected to “hydroxypropyl methylcellulose”.
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, 4-5, 7, 9-17, 19, 21-23 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 pre-AIA the applicant regards as the invention.
Claim 1 recites the limitation “film-forming polymer comprises one or more of hydroxypropyl methylcellulose, ethyl cellulose, methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, cellulose acetate, cellulose acetate trimellitate, polyvinylpyrrolidone, polyvinyl alcohol, and polyethylene glycol” that is unclear, because the structure of the recited compound/polymer/constituent is not clearly delineated. To this point, it is noted that the term “comprising” allows the presence of additional, unrecited compounds/constituents even in a large amount. Therefore, it is unclear what is claimed as “a polymer”. Is it a mixture of compounds (i.e., comprising), OR a block copolymer? Similar is applied to the limitations “enteric polymer comprises” recited in claims 1, as well as to claims 4, 5, 21. Applicant is advised to use the proper Markush group language, i.e., “selected from the group consisting of A, B, … and mixtures thereof” to clearly define constituents that can be used in the claimed product. Clarification is required.
In response to applicant’s argument that newly introduced amendment “polymer comprises one or more” of recited compounds clarifies said limitation, it is noted that the limitation “polymer comprises one recited compound” does not clear define the structure of the recited constituent/polymer. Is it a mixture with other compounds, OR a part of said polymer, e.g., a block copolymer? Clarification is required.
As stated previously, claim 15 recites the limitation “discrete units have an average diameter of from about 500 µm to about 1800µm” that is unclear and indefinite. To this point, it is noted that where a claimed value (i.e., particle/unit diameter) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Without knowing these parameters, the metes and bounds of the claimed subject matter are not reasonably clear. Clarification is required.
In response to applicant’s argument that one of ordinary skill in the art would understand that if the average diameter of the discrete units, as measured by any standard method, falls within the range of "about 500 µm to about 1800 µm," then such discrete units would be encompassed by the claim, it is noted that it is well known in the field that different methods of particle size analysis yield different estimates of particle size for the same sample (see Wikipedia and references cited wherein; “Interpretation of Particle Size Reported by Different Analytical Techniques” on labmanager.com; “Comparison of particle characterization methods” on microtrac.com as cited previously), i.e., experimental estimates of particle sizes depend on methods of measurements used to obtain it. Therefore, said claim does not clearly set forth the metes and bounds of the patent protection desired, and one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. MPEP § 2173.05(c). Therefore, the clarification is required.
Claim 17 recites the limitation “a finishing layer comprising polyethylene glycol, hydroxypropyl methylcellulose, titanium dioxide, and talc” that is not reasonably clear. Does this limitation define “a finishing layer” as a mixture comprising recited compounds, OR comprising at least one of them? Similar is applied to claim 23.
Claims 7, 9-14, 16, 19, 22 are rejected as being dependent on rejected independent claims 1, 17, 21 and failing to cure the defect.
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.
Claims 1, 4-5, 7, 9-17, 19, 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Roy et al., US 2012/0207825 A1 (hereinafter referred to as Roy), in view of Vyas et al., US 2009/0226517 A1 (hereinafter referred to as Vyas), Winter, US 2009/0221668, Nanda et al., Journal of Pharmaceutical Sciences 2021, 110(12):3773-3375 (cited in IDS; hereinafter referred to as Nanda), and Challapalli et al., US 2005/0250838 A1 (hereinafter referred to as Challapalli).
Roy teaches pharmaceutical compositions comprising:
PNG
media_image1.png
280
377
media_image1.png
Greyscale
a drug layer comprising sugar spheres, 67.3 mg of duloxetine hydrochloride (i.e., about 23 wt% by the weight of the composition; shown on the right), hydroxypropyl methylcellulose (HPMC), wherein duloxetine hydrochloride was sprayed over sugar spheres, and further dispersion of HPMC was sprayed over spheres (Para. 0035, 0055-0059, 0060, 0062 as applied to claims 1, 7, 13, 17, 19, 21);
barrier layer comprising sucrose, 15 wt% of hydroxypropyl methylcellulose by the weight of composition, talc (Para. 0055 as applied to claims 1, 4, 9, 17, 21);
enteric layer comprising hydroxypropyl methylcellulose phthalate, triethyl citrate, talc (Para. 0055 as applied to claims 1, 5, 17, 20-21).
Roy teaches that said compositions may include a "separating layer" or a "barrier layer" that are present between the core and a functional layer (Para. 0036), and wherein the functional layer may include the layer that changes/modifies the release of the drug from the dosage form, and wherein said functional layer may include rate-controlling polymers, e.g., hydroxypropyl methylcellulose, ethylcellulose, hydroxypropyl cellulose, methylcellulose, hydroxyethylcellulose, hydroxypropyl methylcellulose phthalate, (Abstract; Para. 0001, 0038- 0040), plasticizer, anti-tacking agent, e.g., polyethylene glycols, and opacifying agent, e.g., 0.1-10 wt% of titanium dioxide to prevent photo-degradation (Para. 0041, 0047-0049 as applied to claims 11, 17, 23). Roy teaches that said compositions can be in a form of pellets, granules, mini-tablets, tablets, capsules (Para. 0042 as applied to claims 14, 16, 22).
Though Roy teaches that said compositions may include such drug combination as duloxetine and ascorbic acid or pharmaceutically acceptable salts thereof (Claim 19; Para. 0034), Roy does not specifically teach that the drug layer comprises duloxetine hydrochloride and ascorbic acid (clams 1, 17).
Vyas teaches pharmaceutical formulations comprising such active agent as duloxetine or its pharmaceutically acceptable salts, e.g., duloxetine hydrochloride (Title, Abstract; Para. 0008, 0076), wherein duloxetine or salt thereof can be used in a combination with acids (e.g., amino acids) for providing improved storage stability of said active agent (Claims 3, 11-12; Abstract; Para. 0105).
PNG
media_image2.png
247
247
media_image2.png
Greyscale
Winter teaches the preparation of duloxetine hydrochloride by a process that provides a maximum yield of desired product/drug with a minimum amount of undesired by-products (Abstract; Para. 0003). To this point, Winter further teaches pharmaceutical formulations comprising duloxetine hydrochloride, wherein said formulations/compositions include ascorbic acid as anti-oxidant agent (Claim 19; Para. 0037).
Nanda teaches that ascorbic acid can be used in pharmaceutical compositions to minimize the formation of nitrosamine (shown on the right) in drug product when nitrite and vulnerable amine is present, and further teaches that it is well known in the field that nitrite is often present as an impurity in excipients at ppm level (Abstract).
Challapalli teaches pharmaceutical formulations providing an extended or controlled release of such antidepressant as duloxetine or hydrochloride salt thereof, e.g., 10-100 mg of duloxetine hydrochloride (Abstract; Para. 0060, 0062, 0143), wherein said antidepressant/active agent is premixed with stabilizers, diluents, binders, solubilizers (Para. 0032). Challapalli specifically teaches the use in said formulations 0.001-3 wt% of such stabilizer as ascorbic acid (Para. 0099, 0111). Challapalli also teaches that a spay solution comprising said active agent can be sprayed onto sugar spheres (Para. 0078), and further teaches that said formulations may also include hydroxypropyl methylcellulose/hypromellose, hydroxypropyl cellulose, hydroxyethyl cellulose, methylcellulose, ethylcellulose, sucrose, sugar spheres, polyethylene glycols (Para. 0104); hydroxypropyl methylcellulose/hypromellose phthalate (Para. 0110), talc, titanium dioxide, triethyl citrate (Para. 0104, 0106, 0111).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include acidic compounds, e.g., ascorbic acid, as taught by Vyas, Winter, Nanda and Challapalli into the drug layer as taught by Roy. One would do so with expectation of beneficial results, because the cited prior art teaches that said approach can be used to improve storage stability of the compositions, and also that ascorbic acid can be used in pharmaceutical compositions to minimize effect of oxidation (i.e., as anti-oxidant) as well as to minimize the formation of nitrosamine in drug product having a vulnerable amine.
With regard to the concentrations instantly claimed, it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Regarding the properties of the disclosed formulations, it is noted that the cited prior art teaches formulations that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. The fact that applicant 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).
Response to Arguments
Applicant's arguments, filed 02/20/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner’s comments are set forth next.
The Declaration under 37 CFR 1.132, filed 02/20/2026, has been considered. To this point, in response to the applicant’s argument that instant invention shows unexpected results that 0.01-0.5 wt% of ascorbic acid allow controlling the amount of such impurities as nitrosoduloxetine and 1-naphthol, it is noted that the cited prior art by Vyas, Winter, Nanda and Challapalli teaches the use of acids, e.g., ascorbic acid, to control stability of duloxetine hydrochloride. Further, it is noted that one skilled in the art would have understood that properties of multicomponent systems depend on compounds included as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of said system/composition. Therefore, it is expected that different compositions might have different properties. The determination of suitable or effective concentration/compositions (for providing/controlling properties of compositions) can be and usually is determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. To this point, it is noted that the applicant shows that some compositions works better than others, but does not explain what is unexpected. Therefore, it is the examiner’s positions that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, because every element of the invention has been collectively taught by the combined teachings of the references cited. Regarding the specific impurities, it is noted that the fact that applicant 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. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Applicant is advised to clarify the claimed language, the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
Prosecution Insights