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
In a telephonic interview with Attorney of Record, Kristina Konstas, on 22 January 2026 it was conveyed the claim set filed on 31 October 2025 and examined in the previous office action did not belong to this application. The correct claim set was filed on 30 July 2025 and is the set used to re-examine the application herein.
Claims 1-27 are pending in the instant application.
Claims 1-27 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 statements (IDS), submitted on 31 October 2025 and 26 January 2026, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Interpretation
Claims 1-27 are directed to a composition; as such, the intended use (i.e. for treating acute pain) does not alter the chemical structure(s) of composition and is therefore not further limiting. See MPEP 2111.02.II:
[S]tatements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963) (The claims were directed to a core member for hair curlers and a process of making a core member for hair curlers. The court held that the intended use of hair curling was of no significance to the structure and process of making.); In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962) (statement of intended use in an apparatus claim did not distinguish over the prior art apparatus). To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.
Claims 7-20 are directed to a composition; as such, the method of making does not alter the chemical structure(s) of composition and is therefore not further limiting. See MPEP 2113 I:
[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Objections to Specification
The use of the term “Lutrol F-127”, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 5, 8-12, 14-15, 21 and 26 recite the pharmaceutical salt or ester of meloxicam. Ester is not described, defined, nor are any examples given, in the specification. As the dependent claims do not remedy the issue they are subject to the rejection as well.
One of ordinary skill in the art would not be able to determine the scope of functional esters of meloxicam based on the specification. The specification does not provide a structural or functional definition of ester, therefore under broadest reasonable interpretation this includes ester prodrugs. Formulation of an ester prodrug would require the applicant to possess the knowledge of which esters would lead to a functional drug and which would not. Lillethorup et al. (RSC Med. Chem.2025;16:1037) details functional issues that arise with ester prodrugs. Due to their structure, ester prodrugs are released by both chemical and enzymatic hydrolysis. This combination of mechanisms can hinder the selectively of drug release. Additionally, an ester prodrug can by hydrolyzed in the gastrointestinal tract, releasing the active compound before it reaches its target and negating the drug’s efficacy while potentially inducing adverse side effects. Not all ester prodrugs will work; structure-function correlation is necessary to establish the bounds of a functional ester prodrug of meloxicam. As the specification does not provide any structure-function correlation to support the bounds of a functional ester of meloxicam, nor are any examples presented in the instant specification, this suggests the applicant is not in possession of a functional ester of meloxicam nor in possession of the knowledge of which esters would or would not maintain the function of meloxicam.
In conclusion, there is no structure-function correlation between what is and what is not a functional ester in the specification. Without the correlation between structure and function or an adequate representation of species functioning as an ester of meloxicam, the instant invention fails to comply with the written description requirement.
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 4 and 24-25 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.
Claims 4 and 24-25 contains the trademark/trade name Lutrol® F-127. 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 a hydrophilic polymer and, accordingly, the identification/description is indefinite.
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 and 8-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 22 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 claims 1-4 and 8-14, the co-pending application recites the pharmaceutical composition comprising meloxicam, or a pharmaceutically acceptable salt or ester, and at least one pharmaceutically acceptable excipient for the treatment of pain (claim 22) wherein the composition is embedded in alkaline surroundings (claim 23).
Regarding claims 15-19, the co-pending application recites the pharmaceutical composition comprising meloxicam, or a pharmaceutically acceptable salt or ester, and at least one pharmaceutically acceptable excipient for the treatment of pain (claim 22) wherein the composition is embedded in alkaline surroundings (claim 23). As the co-pending application teaches the claimed composition the functional outputs of that composition would be expected to meet the functional properties claimed. Therefore, it would appear the claimed limitation of the composition being apply to withstand acidic dissolution media would necessarily occur. MPEP 2112.01:I states:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
Regarding claims 21-27, the co-pending application recites the pharmaceutical composition comprising meloxicam, or a pharmaceutically acceptable salt or ester, and at least one pharmaceutically acceptable excipient for the treatment of pain (claim 22) wherein the composition is embedded in alkaline surroundings (claim 23). As the co-pending application teaches the claimed composition the functional outputs of that composition would be expected to meet the functional properties claimed. Therefore, it would appear the claimed limitation of the composition not precipitating in acidic dissolution media would necessarily occur. See MPEP 2112.01:I.
Claims 1-27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-8, and 15 of co-pending Application No. 19/285,261 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 8, the co-pending application recites a solid oral pharmaceutical composition comprising meloxicam or a pharmaceutically acceptable salt or ester (claim 1) wherein the meloxicam is coated in an alkalizing agent and hydrophilic polymer (claim 15).
Regarding claims 2 and 3, the co-pending application recites the meloxicam composition coated in an alkalizing agent and hydrophilic polymer (claim 15). Wherein the alkaline surroundings are either granules (claim 8) or pellets (claim 15),
Regarding claim 4, the co-pending application recites the alkalizing agents to be ammonium hydroxide, sodium phosphate, sodium acetate, sodium carbonate, sodium bicarbonate, meglumine, ethylamine, triethylamine, ethanediamine, tromethamine, lysine, arginine, histidine, or sodium hydroxide (claim 6). And the hydrophilic polymer(s) to be copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, or Lutrol F-127 (claim 7).
Regarding claims 5 and 9-14, the co-pending application recites the solid oral composition dispersed in a solution containing an alkalizing agent and hydrophilic polymer and then coated in an alkalizing agent and hydrophilic polymer (claim 8 and 15).
Regarding claims 6 and 7, the co-pending application recites the dispersion comprising hydrophilic polymers (claim 8 and 15). The method of making the solid dispersion is not limiting.
Regarding claims 15-20, the co-pending application recites a solid oral pharmaceutical composition comprising meloxicam or a pharmaceutically acceptable salt or ester (claim 1) wherein the alkalized spheres are coated in meloxicam dispersed in an alkalizing agent and hydrophilic polymer and then coated in an alkalizing agent and hydrophilic polymer (claim 15). As the co-pending application teaches the claimed composition the functional outputs of that composition would be expected to meet the functional properties claimed. Therefore, it would appear the claimed limitation of the composition being apply to withstand acidic dissolution media would necessarily occur. MPEP 2112.01:I states:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
Regarding claims 21-22 and 26-27, the co-pending application recites a solid oral pharmaceutical composition comprising meloxicam or a pharmaceutically acceptable salt or ester (claim 1) wherein the alkalized spheres are coated in meloxicam dispersed in an alkalizing agent and hydrophilic polymer and then coated in an alkalizing agent and hydrophilic polymer (claim 15). As the co-pending application teaches the claimed composition the functional outputs of that composition would be expected to meet the functional properties claimed. Therefore, it would appear the claimed limitation of the composition not precipitating in acidic dissolution media would necessarily occur. See MPEP 2112.01:I.
Regarding claims 23-25, the co-pending application recites the alkalizing agents to be ammonium hydroxide, sodium phosphate, sodium acetate, sodium carbonate, sodium bicarbonate, meglumine, ethylamine, triethylamine, ethanediamine, tromethamine, lysine, arginine, histidine, or sodium hydroxide (claim 6). And the hydrophilic polymer(s) to be copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, or Lutrol F-127 (claim 7).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bosch (US9526734B2).
Regarding claims 1-3 and 8-14, Bosch discloses a pharmaceutical composition comprising meloxicam and one or more excipients (column 2, line 30) for treating pain (column 2, line 12). Bosch discloses the composition is prepared when granules of meloxicam, lactose monohydrate, sodium lauryl sulfate (alkalizing agent) and PEG6000 (hydrophilic polymer) are milled together (column 11) to form an attrited blend. That blend can then be combined with microcrystalline cellulose, croscarmellose sodium (hydrophilic polymer), and sodium lauryl sulfate (alkalizing agent). This is further milled with croscarmellose sodium (hydrophilic polymer), sodium lauryl sulfate (alkalizing agent), and sodium stearyl fumarate to produce a final blend of granules (columns 20, example 2), that would be embedded in alkaline surroundings.
Regarding claim 4, Bosch discloses the pharmaceutical composition comprising a millable grinding matrix, a type of excipient, selected from sodium acetate, sodium carbonate, sodium bicarbonate, and sodium hydroxide (column 9).
Regarding claims 5 and 6, the method of milling disclosed by Bosch creates a solid dispersion of meloxicam in the matrix. Bosch discloses hydrophilic polymeric matrices.
Regarding claims 15-17, Bosch discloses a pharmaceutical composition comprising meloxicam and one or more excipients, including alkalizing agents and hydrophilic polymers (column 2, line 30), for treating pain (column 2, line 12). Bosch discloses a method of milling the meloxicam such that it is embedded in an alkaline environment. As the reference teaches the claimed composition, the functional outputs of that composition would be expected to meet the functional properties claimed. Therefore, it would appear the claimed limitation of the composition being apply to withstand acidic dissolution media would necessarily occur. MPEP 2112.01:I states:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
Regarding claims 18 and 19, the method of milling disclosed by Bosch creates a solid dispersion of meloxicam in the matrix. Bosch discloses hydrophilic polymeric matrices.
Regarding claim 20, Bosch discloses formulating the composition into granules to be encapsulated (column 20).
Regarding claims 21-22 and 26-27, Bosch discloses a pharmaceutical composition comprising meloxicam and one or more excipients, including alkalizing agents and hydrophilic polymers (column 2, line 30), for treating pain (column 2, line 12). Bosch discloses a method of milling the meloxicam such that it is embedded in an alkaline environment. As the reference teaches the claimed composition, the functional outputs of that composition would be expected to meet the functional properties claimed. Therefore, it would appear the claimed limitation of the composition not precipitating in acidic dissolution media would necessarily occur. See MPEP 2112.01:I.
Regarding claim 23, Bosch discloses the pharmaceutical composition comprising a millable grinding matrix, a type of excipient, selected from sodium acetate, sodium carbonate, sodium bicarbonate, and sodium hydroxide (column 9).
Regarding claims 24-25, 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).
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 8-12 and 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). As the process of making is not further limiting, the claims are substantial duplicates.
Applicant is advised that should claim 6 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). As the process of making is not further limiting, the claims are substantial duplicates.
Conclusion
Claims 1-27 are rejected.
Claims 7-12 and 14 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