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 1-25 are pending in the instant application.
Claims 1, 4, 5, 8, 10, 12, 14-15, 17, 21, and 24 are amended
Claims 2-3, 6-7,9, 11, 13, 16, 18-20, 22-23, and 25 are cancelled
Claims 26-35 are new.
Claims 1, 4, 5, 8, 10, 12, 14-15, 17, 21, 24, and 26-35 are examined herein.
Priority
The instant application is a CIP of U.S. Patent Application No. 18/251,923, filed on 05 May 2023, and claims benefit of foreign priority to IN202041048559, filed on 06 November 2020, and the benefit of priority to PCT/IB2021/060148, filed on 03 November 2021. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 06 November 2020.
Information Disclosure Statement
The information disclosure statement (IDS), submitted on 31 October 2025 and 23 January 2026, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 06 February 2026 has been entered.
In view of applicant amendment to specification, the trademark objection of record is withdrawn.
In view of applicant amendment to claim 10, the objection of record is withdrawn.
In view of applicant amendment to claims 1, 8, and 15, the 112(a)-written description objection of record is withdrawn.
In view of applicant amendment to claim 1 and the filed affidavit, the 102(a)(1) rejections of record over Bosch, Friedl, and Tabuteau are all withdrawn. All three references fail to disclose the amended limitation of a solid oral pharmaceutical composition comprising amorphous meloxicam. Additionally, Friedl does not teach the required tablet dosage form.
In view of applicant amendment to claim 1 and the filed affidavit, the 103 rejection of record over Bosch in view of Karolewicz is withdrawn for the same reasons above.
In view of applicant amendment to claim 1 and the filed affidavit, the 103 rejection of record over Tabuteau in view of Srisha and Brady is withdrawn for the same reasons above.
With respect to the double patenting rejection, as the co-pending application has an earlier filing date the rejection is maintained and modified below in light of the claim amendments.
In addition, new rejections and objections are necessitated by amendment (see below).
All rejections and objections not found below have been withdrawn.
Consideration of Affidavit
The affidavit written by Amit Antarkar, filed on 06 February 2026, is acknowledged and found sufficient to further support the pending claims.
To demonstrate the interchangeability of hydrophilic polymers in the formulation, three formulations were tested, with ingredients tabulated in the first table of paragraph 8 and results of dissolution in the second table. The Viatris formulation contains copovidone, Formulation 9 contains povidone, and Formulation 10 contains hydroxypropyl methylcellulose. All three formulations result in comparable dissolution time, demonstrating various hydrophilic polymers can be used in the formulation.
To demonstrate the interchangeability of water-soluble alkalizing agents in the formulation, four formulations were tested, with ingredients tabulated in the first table of paragraph 9 and results of dissolution in the second table. Formulation 4 contains meglumine, Formulation 5 contains sodium hydroxide, Formulation 6 contains lysine, and Formulation 7 contains sodium carbonate. All four formulations result in comparable dissolution time, demonstrating various water-soluble alkalizing agents can be used in the formulation. Formulation 8 shows the composition with a water-insoluble alkalizing agent, calcium carbonate. Not only does the dissolution time significantly decrease, but the meloxicam retains its crystalline form.
Antarkar next compares the Viatris Formulation to two formulations, one to model Tablet E as disclosed by Tabuteau (Formulation 3), and the other meloxicam is added to placebo granules (Formulation 2). This experiment demonstrates the importance of the amorphous meloxicam in the formulation to the dissolution profile. Both Formulation 2 and 3 contain crystalline meloxicam and have a significantly decreased dissolution profile. This also demonstrates that Tabuteau’s formulation would contain crystalline meloxicam and subsequently the superior results of the instant invention to the prior art.
Finally, PXRD studies demonstrate that the manufacturing process of the instant invention converts crystalline meloxicam to its amorphous form. This amorphous form is integral to the instant invention and results in a superior dissolution profile to the commercially available meloxicam formulations.
Overall, the affidavit establishes the product made by the recited process is not the same product presented by Bosch, Tabuteau or Friedl. Instead, due to the incorporation of a hydrophilic polymer and water-soluble alkalizing agent with amorphous meloxicam to produce a solid oral tablet the instant invention yields a composition with a superior dissolution profile resulting in improved bioavailability.
MAINTAINED REJECTIONS
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, 4, 5, 8, 10, 12, 14-15, 17, 21, 24, 26-31, and 33-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 8-13, and 23 of co-pending Application No. 18/251,923 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the co-pending application recites the pharmaceutical composition comprising meloxicam, and at least one pharmaceutically acceptable excipient (claim 1) wherein the pharmaceutically acceptable excipient comprises one or more hydrophilic polymers or alkalizing agents (claim 8) and the composition is in the form of a tablet (claim 4).
Regarding claims 4, the co-pending application recites the alkalizing agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, meglumine, and combinations thereof (claim 11).
Regarding claims 5, the co-pending application recites the hydrophilic polymer is selected from the group consisting of copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose and combinations thereof (claim 9).
Regarding claim 8, the co-pending application recites the pharmaceutical composition, which would include drug granules, comprising meloxicam and at least one pharmaceutically acceptable excipient (claim 1). The method of making recited in the instant application is not limiting.
Regarding claims 10, the co-pending application recites the hydrophilic polymer is selected from the group consisting of copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose and combinations thereof (claim 9).
Regarding claim 12, the co-pending application recites the alkalizing agent is selected from the group consisting of sodium carbonate, sodium bicarbonate, meglumine, and combinations thereof (claim 11).
Regarding claims 14, the co-pending application recites the pharmaceutical composition (claim 1) in tablet form (claim 4). The method of preparation is not limiting.
Regarding claim 15, the co-pending application recites the pharmaceutical composition, which would include drug pellets, comprising meloxicam and at least one pharmaceutically acceptable excipient (claim 1) wherein the pharmaceutically acceptable excipient comprises one or more hydrophilic polymers or alkalizing agents (claim 8) and the composition is in the form of a tablet (claim 4). The method of making recited in the instant application is not limiting.
Regarding claim 17, the co-pending application recites the pharmaceutical composition, which would include drug granules, comprising meloxicam and at least one pharmaceutically acceptable excipient (claim 1) wherein the pharmaceutically acceptable excipient comprises one or more hydrophilic polymers or alkalizing agents (claim 8), the compositions comprises 5 mg to 50 mg of meloxicam (claim 6), and the composition is in the form of a tablet (claim 4). The method of making recited in the instant application is not limiting.
Regarding claim 21, the co-pending application recites the hydrophilic polymer as copovidone (claim 10) and the alkalizing agent as sodium bicarbonate (claim 12).
Regarding claims 24, the co-pending application recites the pharmaceutically acceptable excipient comprises one or more lubricants (claim 8).
Regarding claim 26 and 27, the co-pending application recites the meloxicam is embedded in alkaline surrounding (claim 23).
Regarding claim 28, the co-pending application recites the composition comprising 5 mg to 50 mg of meloxicam (claim 6).
Regarding claim 29, the co-pending application recites the hydrophilic polymer is selected from the group consisting of copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose and combinations thereof (claim 9).
Regarding claim 30 and 31, the co-pending application recites the pharmaceutically acceptable excipient comprises one or more diluents, binders, hydrophilic polymers, lubricants, glidants, disintegrants, alkalizing agents, coating materials, solvents or combinations thereof (claim 8).
Regarding claim 33 and 34, the co-pending application recites the alkalizing agent, sodium bicarbonate, to be present in an amount from 100 mg to 400 mg (claim 13).
NEW REJECTIONS/OBJECTIONS FACILITATED BY AMENDMENT
Claim Objections
Claim 17 is objected to because of the following informalities:
Claim 17 recites an alphabetic numeral system but lists “(A)” twice. The second “(A)” should be “(B)”.
Appropriate correction is required.
Claims 32 and 35 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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, 4, 5, 8, 10, 12, 14-15, 17, 21, 24, 26-27, and 30-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 20 of co-pending Application No. 19/285,330 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the co-pending application recites the pharmaceutical composition comprising meloxicam, and at least one pharmaceutically acceptable excipient (claim 1) wherein the pharmaceutically acceptable excipient comprises one or more hydrophilic polymers or alkalizing agents (claim 2) and the composition is in the form of a tablet (claim 20).
Regarding claims 4, the co-pending application recites the alkalizing agent is selected from the group consisting of ammonium hydroxide, sodium phosphate, sodium acetate, sodium carbonate,
sodium bicarbonate, meglumine, ethylamine, triethylamine, ethanediamine, tromethamine, lysine,
20 arginine, histidine, or sodium hydroxide (claim 4).
Regarding claims 5, the co-pending application recites the hydrophilic polymer is selected from the group consisting of copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, or combinations thereof (claim 4).
Regarding claim 8, the co-pending application recites the pharmaceutical composition comprising drug granules of meloxicam and at least one pharmaceutically acceptable excipient (claim 2). The method of making recited in the instant application is not limiting.
Regarding claims 10, the co-pending application recites the hydrophilic polymer is selected from the group consisting of copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, or combinations thereof (claim 4).
Regarding claim 12, the co-pending application recites the alkalizing agent is selected from the group consisting of ammonium hydroxide, sodium phosphate, sodium acetate, sodium carbonate,
sodium bicarbonate, meglumine, ethylamine, triethylamine, ethanediamine, tromethamine, lysine,
20 arginine, histidine, or sodium hydroxide (claim 4).
Regarding claims 14, the co-pending application recites the pharmaceutical composition (claim 1) in tablet form (claim 20). The method of preparation is not limiting.
Regarding claim 15, the co-pending application recites the pharmaceutical composition comprising drug pellets of meloxicam and at least one pharmaceutically acceptable excipient wherein the pharmaceutically acceptable excipient comprises one or more hydrophilic polymers or alkalizing agents (claim 2) and the composition is in the form of a tablet (claim 20). The method of making recited in the instant application is not limiting.
Regarding claim 17, the co-pending application recites the pharmaceutical composition, which would include drug granules, comprising meloxicam and at least one pharmaceutically acceptable excipient (claim 1) wherein the pharmaceutically acceptable excipient comprises one or more hydrophilic polymers or alkalizing agents (claim 8), the compositions comprises 5 mg to 50 mg of meloxicam (claim 6), and the composition is in the form of a tablet (claim 4). The method of making recited in the instant application is not limiting.
Regarding claim 21, the co-pending application recites the hydrophilic polymer can be copovidone and the alkalizing agent can be sodium bicarbonate (claim 4).
Regarding claims 24, the co-pending application recites one or more pharmaceutically acceptable excipients which comprises lubricants (claim 1).
Regarding claim 26 and 27, the co-pending application recites the meloxicam is embedded in alkaline surrounding (claim 1).
Regarding claim 30 and 31, the co-pending application recites a pharmaceutically acceptable excipient which includes diluents, binders, hydrophilic polymers, lubricants, glidants, disintegrants, alkalizing agents, coating materials, solvents or combinations thereof (claim 1).
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.
Claim(s) 1, 4, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bosch (US9526734B2) in view of Suzuki et al. (Journal of Pharmaceutical Sciences.2018;107:446-452).
Regarding claim 1, Bosch discloses a pharmaceutical composition comprising meloxicam and one or more excipients (column 2, line 30), which includes hydrophilic polymers and alkalizing agents and discloses the pharmaceutical composition as a tablet (column 6, line 47).
Bosch does not disclose the meloxicam to be amorphous.
Suzuki discloses enhanced oral absorption of amorphous meloxicam and hydroxypropylmethyl cellulose (abstract).
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. It would be prima facie obvious to one ordinary skill in the art to replace the crystalline meloxicam of Bosch’s formulation with the amorphous meloxicam taught by Suzuki. The skilled artisan would be guided to making this substitution as both Bosch and Suzuki teach the same compound for the same utility. And the skilled artisan would be motivated to making the substitution based on the increased bioavailability taught by Suzuki.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claim 4, Bosch discloses the formulation can include sodium acetate, sodium carbonate, sodium bicarbonate, and sodium hydroxide (column 9).
Regarding claim 5, Bosch discloses the pharmaceutical composition may include one or more polymers including polyethylene glycol (PEG), the polymer of vinyl pyrrolidone and vinyl acetate (copovidone), polyvinylpyrrolidone (povidone), hydroxypropylmethyl cellulose (hypromellose), and hydroxypropyl cellulose (column 18).
Conclusion
Claims 1, 4, 5, 8, 10, 12, 14-15, 17, 21, 24, 26-27, and 30-31 are rejected.
Claims 32 and 35 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621