DETAILED ACTION
Status of Claims
Claims 1-4, 8-14 and 16-32 are currently pending. Claims 1-4, 8-14 and 16-24 are currently under consideration and are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 25-32 are withdrawn from consideration. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Office Action: Non-Final.
Election/Restrictions
Applicant’s election of the claims of Group I (claims 1-4, 8-14 and 16-24) in the response filed on December 15, 2025 (to the October 23, 2025 Requirement for Restriction) is acknowledged. In response to applicant’s election, the claims of Group II (claims 35-32) are withdrawn from further consideration pursuant to 37 C.F.R. § 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. It is noted that new claims 31-32 are drawn as method claims (although depending on product claims 4 and 18), and therefore grouped with the withdrawn, method claims of Group II. Applicant has elected the claims of Group I without traverse.
Accordingly, the October 23, 2025 Requirement for Restriction is made FINAL, and claims 1-4, 8-14 and 16-24 are examined as follows.
Claim Rejections – 35 U.S.C. § 112 - Indefiniteness
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, 11-14, 18, 22 and 24 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 , that applicant regards as the invention.
A. Claims 4, 13-14 and 18 contain the trademark/trade name, “MOBIC.” 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, 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 particular formulation of an oral suspension or tablet of meloxicam at par. [0006] of the instant published application, US 2025/0352479 A1, and, accordingly, the identification/description is indefinite. Subsequent claims 14 depend on claim 13, and are thus, indefinite as well.
B. Claim 4 is drawn to
4. ([…]) The solid oral pharmaceutical composition of claim 3, wherein the composition provides a mean bioavailability (AUC) in healthy adult humans under fasting condition that is not more than about 20% of the bioavailability provided by MOBIC containing 15 mg meloxicam when administered to healthy adult humans under fasting conditions.
wherein the recitation of the term, “mean bioavailability (AUC),” renders the metes and bounds of the claim unclear. The instant published application, US 2025/0352479 A1, at par. [0052]-[0053], describe “[m]easures of bioavailability are well known in the art and include the area under the plasma concentration-time curve (AUC), the maximum concentration (Cmax), and the time to reach Cmax (Tmax).” However, it is unclear as to whether “mean bioavailability” in claim 4 encompasses either “AUC,” “Cmax” or “Tmax,” or is limited to the parenthetical “AUC,” alone. To the extent applicant intends the latter, the claim should be amended to recite “mean bioavailability measured as area under a plasma concentration-time curve (AUC).” Further in this respect, it is noted that the Board has held: “if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (expanded panel).
C. Claims 11-12, 22 and 24 contain 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, 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 poloxamer-407, and, accordingly, the identification/description is indefinite.
D. Claim 18 is indefinite for similar reasons as discussed above for recitation of the term, “mean bioavailability (AUC).”
Further clarification is required.
Claim Rejections – 35 U.S.C. § 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.
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 pre-AIA 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 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 C.F.R. § 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 1-4, 8-14 and 16-24 are rejected under 35 U.S.C. § 103 as being unpatentable over FRIEDL (US 2005/0053669 A1, Publ. Mar. 10, 2005; on 10/31/2025 IDS; hereinafter, “Friedl”).
Friedl is directed to:
PHARMACEUTICAL COMPOSITION COMPRISING MELOXICAM
ABSTRACT
The invention relates to a new formulation for oral administration of active substances with pH-dependent solubility characteristics and the pharmacologically acceptable salts thereof, which improves the bioavailability of the active substance.
Friedl, title & abstract. In this regard, Friedl exemplifies a meloxicam formulation:
Meloxicam Examples:
[0126]
[…]
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Friedl, par. [0126], Ex.’s c31 & c32.
Regarding independent claims 1, 13 and 16 and the requirements:
1. ([…]) A solid oral pharmaceutical composition for treating acute pain in an individual in need thereof, the composition comprising meloxicam or a pharmaceutically acceptable salt or ester thereof in an amount equivalent to 15 mg meloxicam effective for treating acute pain and one or more pharmaceutically acceptable excipients,
wherein the composition provides a median meloxicam Tmax of less than about 3.5 hours after administration to health humans under fasting conditions.
[…]
13. ([…]) A solid oral pharmaceutical composition for treating acute pain in an individual in need thereof, the composition comprising meloxicam or a pharmaceutically acceptable salt or ester thereof in an amount equivalent to 15 mg meloxicam and one or more pharmaceutically acceptable excipients, wherein the composition provides a mean meloxicam Tmax about 15 minutes less than the mean Tmax provided by MOBIC containing 15 mg meloxicam after administration to healthy adult humans under fasting conditions.
[…]
16. ([…]) A solid oral pharmaceutical composition for treating acute pain in an individual in need thereof, the composition comprising meloxicam or a pharmaceutically acceptable salt or ester thereof in an amount equivalent to 15 mg meloxicam and one or more pharmaceutically acceptable excipients, wherein the composition provides a meloxicam Cmax of between about 2000 ng/ml to about 3500 ng/ml after administration to healthy adult humans under fasting conditions.
Friedl clearly teaches a meloxicam formulation (Friedl, par. [0126], Ex.’s c31 & c32), WHEREBY it is noted:
“meloxicam” (Friedl, par. [0126], Ex.’s c31 & c32) is “meloxicam” of claims 1, 13 and 16;
“meglumine starter” (Friedl, par. [0126], Ex.’s c31 & c32) is encompassed by “one or more pharmaceutically acceptable excipients” of claims 1, 13 and 16, as well as “one or more alkalizing agents” and “meglumine” of claims 8-9 and 19-20:
8. ([…]) The solid oral pharmaceutical composition of claim 3, wherein the composition comprises one or more alkalizing agents.
9. ([…]) The solid oral pharmaceutical composition of claim 8, wherein the alkalizing agent or agents comprise ammonium hydroxide, sodium phosphate, sodium acetate, sodium carbonate, sodium bicarbonate, meglumine, ethylamine, triethylamine, ethanediamine, tromethamine, lysine, arginine, histidine, or sodium hydroxide, or any combination thereof.
[…]
19. ([…]) The solid oral pharmaceutical composition of claim 17, wherein the composition comprises one or more alkalizing agents.
20. ([…]) The solid oral pharmaceutical composition of claim 19, wherein the alkalizing agent or agents comprise ammonium hydroxide, sodium phosphate, sodium acetate, sodium carbonate, sodium bicarbonate, meglumine, ethylamine, triethylamine, ethanediamine, tromethamine, lysine, arginine, histidine, or sodium hydroxide, or any combination thereof.
[…]
“povidone K 90” (Friedl, par. [0126], Ex.’s c31 & c32) is encompassed by “one or more pharmaceutically acceptable excipients” of claims 1, 13 and 16, as well as “one or more hydrophilic polymers” and “povidone” of claims 10-12 and 21-24:
10. ([…]) The solid oral pharmaceutical composition of claim 3, wherein the composition comprises one or more hydrophilic polymers.
11. ([…]) The solid oral pharmaceutical composition of claim 10, wherein the hydrophilic polymer or hydrophilic polymers comprise copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, or Lutrol F-127, or any combination thereof.
12. ([…]) The solid oral pharmaceutical composition of claim 9, wherein the composition comprises one or more hydrophilic polymers selected from copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, and Lutrol F-127, and any combination thereof.
[…]
21. ([…]) The solid oral pharmaceutical composition of claim 17, wherein the composition comprises one or more hydrophilic polymers.
22. ([…]) The solid oral pharmaceutical composition of claim 17, wherein the hydrophilic polymer or hydrophilic polymers comprises copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, or Lutrol F-127, or any combination thereof.
23. ([…]) The solid oral pharmaceutical composition of claim 20, wherein the composition further comprises one or more hydrophilic polymers.
24. ([…]) The solid oral pharmaceutical composition of claim 23, wherein the hydrophilic polymer or hydrophilic polymers is selected from copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, and Lutrol F-127, and any combination thereof.
However, Friedl’s exemplary meloxicam formulation contain 2.85 wt.% and 5.78 wt.% meloxicam (Friedl, par. [0126], Ex.’s c31 & c32), and therefore, Friedl DOES NOT EXPRESSLY TECH an exemplary embodiment with “an amount equivalent to 15 mg meloxicam” as required by claims 1, 13 and 16, which is well within the purview of the ordinarily skilled artisan, in light of Friedl’s broader disclosure. In this regard, it is noted that a reference is analyzed using its broadest teachings. MPEP § 2123 [R-5] states: “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. With regard to suitable amounts of meloxicam, Friedl teaches:
[0037] For meloxicam, for example, daily doses of 4 mg to 30 mg, preferably capsules containing 7.5 mg or 15.0 mg are suitable.
Friedl, par. [0037]. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to rearrange Friedl’s exemplary meloxicam formulation (Friedl, par. [0126], Ex.’s c31 & c32) per Friedl’s broader disclosure to contain “daily doses of 4 mg to 30 mg” (Friedl, par. [0037]). In this regard, it is noted that MPEP § 2144.05 (I), states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d, 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).”
Regarding claims 1, 13 and 16, it is noted that the requirement, “treating acute pain,” is a recitation of intended use. In this regard, it is noted that recitations of intended use must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it reads on the claim. See MPEP § 2103 (I)(C)). Since Friedl teaches the structure of the instant composition, as discussed above, then it reasonably follows that Friedl’s composition would be capable of performing the intended use.
Regarding claims 1, 13 and 16, it is noted that the requirements:
“wherein the composition provides a median meloxicam Tmax of less than about 3.5 hours after administration to health humans under fasting conditions” (claim 1),
“wherein the composition provides a mean meloxicam Tmax about 15 minutes less than the mean Tmax provided by MOBIC containing 15 mg meloxicam after administration to healthy adult humans under fasting conditions” (claim 13), and
“wherein the composition provides a meloxicam Cmax of between about 2000 ng/ml to about 3500 ng/ml after administration to healthy adult humans under fasting conditions” (claim 16),
as well as the requirements of claims 2-4, 14 and 17-18:
2. ([…]) The solid oral pharmaceutical composition of claim 1, wherein the composition provides a median meloxicam Tmax within less than about 90 minutes after administration to healthy humans under fasting conditions.
3. ([…]) The solid oral pharmaceutical composition of claim 2, wherein the composition provides a median meloxicam Tmax within less than about 60 minutes after administration to healthy humans under fasting conditions.
4. ([…]) The solid oral pharmaceutical composition of claim 3, wherein the composition provides a mean bioavailability (AUC) in healthy adult humans under fasting condition that is not more than about 20% of the bioavailability provided by MOBIC containing 15 mg meloxicam when administered to healthy adult humans under fasting conditions.
[…]
14. ([…]) The solid oral pharmaceutical composition of claim 13, wherein the composition provides a mean meloxicam Tmax about 1.0 hours, 2 hours, 2.5 hours, or 3 hours less than the mean Tmax provided by MOBIC containing 15 mg meloxicam after administration to healthy adult humans under fasting conditions.
[…]
17. ([…]) The solid oral pharmaceutical composition of claim 16, wherein the composition provides a mean meloxicam Cmax of between about 2200 ng/ml to about 3400 ng/ml after administration to healthy adult humans under fasting conditions.
18. ([…]) The solid oral pharmaceutical composition of claim 17, wherein the composition provides a mean bioavailability (AUC) in healthy adult humans under fasting conditions that is not more than about 20% of the mean bioavailability provided by MOBIC containing 15 mg after administration to healthy adult humans under fasting conditions.
are functional limitations. In this regard, it is noted that the structure, material or act in the claim that is connected to (i.e., performs) the recited function is the combination of recited elements of claims 1, 13 and 16, which achieve the resulting release effects. Therefore, the broadest reasonable interpretation (see MPEP § 2111 with respect to broadest reasonable interpretation) of the functional language is: an intended release effect of a composition that meets the structural requirements of claims 1, 13 and 16. Because this functional language merely recites the intended result of the recited structural limitations, it imposes no patentable distinction on the claim (i.e., the functional language is not further limiting beyond the noted structural limitations). Therefore, one of ordinary skill in the art would understand that a composition meeting the structural requirements of claims 1, 13 and 16 will achieve the intended result of the functional limitations and fall within the boundaries of the claims. Further, in this respect, it is noted, “[w]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); and also MPEP § 2144.05(II)(A). In the instant case, relase effect is clearly a result-effective variable, which Friedly teaches “absorbability can also be predicted with some accuracy” using Friedl’s “empirical test method,” which “is suitable for optimising drug preparations” for “maximum release and/or the area under the curve (AUC) from time 0 to the end of the release”
[0043] Therefore, within the scope of the invention, an empirical test method was developed which has a better correlation with the in vivo performance in humans. In this procedure, a drug preparation which contains the maximum dose used in humans is released in a volume of 200 ml (this corresponds to the dose in humans) in buffer at a pH with reduced solubility of the active substance in the physiologically acceptable range, i.e. between pH 1-7. As the absorbability can also be predicted with some accuracy using this method, even at non-acidic gastric pH levels, it is suitable for optimising drug preparations. In order to identify the most favourable formulation in each case from a number of possible recipes, the maximum release and/or the area under the curve (AUC) from time 0 to the end of the release may be used as relevant characteristics.
Friedl, par. [0037]. Therefore, it would have been customary for an artisan of ordinary skill to optimize Friedl’s exemplary meloxicam formulation (Friedl, par. [0126], Ex.’s c31 & c32) per Friedl’s “empirical test method” for “maximum release and/or the area under the curve (AUC) from time 0 to the end of the release” (Friedl, par. [0037]) in order to attain the release effects recited in claims 1-4, 13-14 and 16-18.
Thus, Friedl renders 1-4, 8-14 and 16-24 obvious.
Claim Rejections - Nonstatutory 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 obviousness-type 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
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).
Claims 1-4, 8-14 and 16-24 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-13, 16 and 18-23 of copending Application No. 18/251,923 (‘923 Application). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a solid pharmaceutical composition comprising meloxicam, and pharmaceutically acceptable excipients such as an alkalizing agent and hydrophilic polymer.
Thus, claims 1-13, 16 and 18-23 of the ‘923 Patent anticipate claims 1-4, 8-14 and 16-24.
Claims 1-4, 8-14 and 16-24 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-25 of copending Application No. 19/285,261 (‘261 Application). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a solid pharmaceutical composition comprising meloxicam, and pharmaceutically acceptable excipients such as an alkalizing agent and hydrophilic polymer.
Thus, claims 1-25 of the ‘261 Patent anticipate claims 1-4, 8-14 and 16-24.
Claims 1-4, 8-14 and 16-24 are provisionally rejected on the ground of nonstatutory double patenting over claims 1-25 of copending Application No. 19/285,330 (‘330 Application). This is a provisional double patenting rejection since the conflicting claims have not in fact been patented.
Although the conflicting claims are not identical, they are not patentably distinct because the instant claims as well as the copending claims are drawn to a solid pharmaceutical composition comprising meloxicam, and pharmaceutically acceptable excipients such as an alkalizing agent and hydrophilic polymer.
Thus, claims 1-25 of the ‘330 Patent anticipate claims 1-4, 8-14 and 16-24.
Conclusion
Claims 1-4, 8-14 and 16-24 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOMINIC LAZARO whose telephone number is (571)272-2845. The examiner can normally be reached on Monday through Friday, 8:30am to 5:00pm EST; alternating Fridays out.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, BETHANY BARHAM can be reached on (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DOMINIC LAZARO/Primary Examiner, Art Unit 1611