Prosecution Insights
Last updated: May 29, 2026
Application No. 19/285,358

PHARMACEUTICAL COMPOSITION COMPRISING MELOXICAM

Final Rejection §103§112
Filed
Jul 30, 2025
Priority
Nov 06, 2020 — IN 202041048559 +2 more
Examiner
LAZARO, DOMINIC
Art Unit
1611
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Mylan Laboratories Ltd.
OA Round
2 (Final)
63%
Grant Probability
Moderate
3-4
OA Rounds
2y 4m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants 63% of resolved cases
63%
Career Allowance Rate
411 granted / 651 resolved
+3.1% vs TC avg
Strong +31% interview lift
Without
With
+31.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
27 currently pending
Career history
691
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
60.2%
+20.2% vs TC avg
§102
6.5%
-33.5% vs TC avg
§112
5.9%
-34.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 651 resolved cases

Office Action

§103 §112
DETAILED ACTION Status of Claims The amendments, and arguments, filed April 02, 2026, are acknowledged and have been fully considered. Claims 1-4, 9-14, 16-18 and 20-36 are pending. Claims 1, 4, 9-14, 16, 18, 20, 22 and 24 have been amended; new claims 33-36 have been added; claims 25-32 have been withdrawn; claims 8 and 19 have been cancelled; and claims 5-7 and 15 were previously cancelled. Claims 1-4, 9-14, 16-18, 20-24 and 33-36 are currently under 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 Status of Office Action: Final Withdrawn Claim Rejections The rejection of claims 4, 11-14, 18, 22 and 24 under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite (items A., B., C. and D. at par. 3-4 of the 01/02/2026 Office action), is withdrawn in light of applicant’s 04/02/2026 amendments. Applicant’s 04/02/2026 remarks at p. 2, par. 4 to p. 4, par. 1, are acknowledged. The rejection of claims 1-4, 8-14 and 16-24 under 35 U.S.C. § 103 over FRIEDL (US 2005/0053669 A1) (at par. 5-10 of the 01/02/2026 Office action), is withdrawn in light of applicant’s 04/02/2026 amendments (in particular, the amendment to independent claim 1 reciting, “including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising one or more of the water-soluble alkalizing agents”). Applicant’s 04/02/2026 arguments at p. 4, par. 2 to p. 5, par. 3, cont. on p. 6, are acknowledged, but are moot in light of the new rejections presented herein. The nonstatutory double patenting rejection of claims 1-4, 8-14 and 16-24 over claims 1-4, 8-14 and 16-24 of US copending Appl. No. 18/251,923 (at par. 11-13 of the 01/02/2026 Office action), is withdrawn in light of the electronic terminal disclaimer filed April 02, 2026 for US Appl. No. 18/251,923, which was approved April 02, 2026. The nonstatutory double patenting rejection of claims 1-4, 8-14 and 16-24 over claims 1-25 of US copending Appl. No. 19/285,261 (at par. 14-16 of the 01/02/2026 Office action), is withdrawn in light of the electronic terminal disclaimer filed April 02, 2026 for US Appl. No. 19/285,261, which was approved April 02, 2026. The nonstatutory double patenting rejection of claims 1-4, 8-14 and 16-24 over claims 1-25 of US copending Appl. No. 19/285,330 (at par. 17-19 of the 01/02/2026 Office action), is withdrawn in light of the electronic terminal disclaimer filed April 02, 2026 for US Appl. No. 19/285,330, which was approved April 02, 2026. New Claim Objections – Necessitated by Amendments The following claims are objected to because of the following informalities: A. Claim 1 is objected to because the claim should read: 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 including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising the one or more of the water-soluble alkalizing agents, and wherein the composition provides a median meloxicam Tmax of less than about 3.5 hours after administration to health humans under fasting conditions. B. Claim 13 is objected to because the claim should read: 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 including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising the one or more of the water-soluble alkalizing agents, and wherein the composition provides a mean meloxicam Tmax about 15 minutes less than the mean Tmax provided by conventional meloxicam tablets containing 15 mg meloxicam after administration to healthy adult humans under fasting conditions. C. Claim 16 is objected to because the claim should read: 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 including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising the one or more of the water-soluble alkalizing agents, 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. Appropriate correction is required. New Claim Rejections – 35 U.S.C. § 112 – Indefiniteness Necessitated by Amendments 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, 13-14, 18 and 36 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. Claim 4 is drawn to: 4. ([…]) The solid oral pharmaceutical composition of claim 3, wherein the composition provides a mean bioavailability measured as area under a plasma concentration-time curve (AUC) in healthy adult humans under fasting condition that is not more than about 20% of the bioavailability provided by conventional meloxicam tablets containing 15 mg meloxicam when administered to healthy adult humans under fasting conditions. wherein the recitation, “conventional meloxicam tablets,” is indefinite because it is unclear as to what the particular composition represents “conventional meloxicam tablets” in comparison to the instant “solid oral pharmaceutical” (i.e., a “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 including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising [the] one or more of the water-soluble alkalizing agents” recited in claim 1). For instance, it is unclear as to whether “conventional meloxicam tablets” differ from the “solid oral pharmaceutical” in terms of the presence or absence of “one or more water-soluble alkalizing agents,” some other component, or some combination of other components. In this regard, 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). B. Claim 13 is indefinite for similar reasons as discussed above in item A. for claim 4. Subsequent claim 14 depends on claim 13 and are thus, indefinite as well. C. Claim 14 is indefinite for similar reasons as discussed above in item A. for claim 4. D. Claim 18 is indefinite for similar reasons as discussed above in item A. for claim 4. Subsequent claim 36 depends on claim 18 and are thus, indefinite as well. Further clarification is required. New Claim Rejections – 35 U.S.C. § 103 Necessitated by Amendments 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, 9-14, 16-18, 20-24 and 33-36 are rejected under 35 U.S.C. § 103 as being unpatentable over XIE (CN 1233323 C, Publ. Dec. 28, 2005; on 10/31/2025 IDS; as evidenced by English language translation of CN 1233323 C; hereinafter, “Xie”). Page and line numbers for Xie refer to English language translation of CN 1233323 C. Xie is directed to: Orally disintegrating tablet of meloxicam and its preparation Abstract The present invention discloses an oral disintegrating tablet of meloxicam. Meloxicam is used as a main drug; auxiliary materials comprise lactose, mannitol, cellulose microcrystalline, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, sodium bicarbonates, citric acids, aspartame, essence and magnesium stearate. The present invention has favorable curative effects on rheumatoid arthritis and painful osteoarthritis; the present invention which can be conveniently taken and quickly disintegrated offers convenience to old people, infants, babies, children or patients with the obstacle for taking medicines or inconvenience for taking water. Xie, title & abstract. In this regard, Xie disclosed a claim embodiment directed to “meloxicam orally disintegrating tablets” obtainable by a “raw material pulverizing, weighing mixing, granulation, sheeting process”: 1, a kind of meloxicam orally disintegrating tablets is characterized in that being made up of principal agent and adjuvant, and its percentage by weight is respectively: principal agent 3~15%, adjuvant 85~97%; Principal agent is a meloxicam, and adjuvant is made up of following weight percentages: A, lactose 0 ~ 70% B, mannitol 0 ~ 60% C, microcrystalline Cellulose 15 ~ 30% D, low-substituted hydroxypropyl cellulose 0 ~ 10% E, crospolyvinylpyrrolidone 3 ~ 10% F, sodium bicarbonate 0.5 ~ 5% G, citric acid 0.5 ~ 5% H, aspartame 0.5 ~ 1% I, essence 0.5 ~ 1% J, magnesium stearate 0.5 ~ 5% Wherein, lactose, mannitol are filler; Low-substituted hydroxypropyl cellulose, microcrystalline Cellulose and crospolyvinylpyrrolidone are disintegrating agent; Citric acid, sodium bicarbonate are effervescent; Magnesium stearate is a lubricant; Aspartame, essence are correctives. 2, the preparation method of meloxicam orally disintegrating tablets according to claim 1 comprises raw material pulverizing, weighing mixing, granulation, sheeting process, it is characterized in that: concrete processing step is as follows: Step 1: with meloxicam and various adjuvant pulverize separately, cross 50~100 mesh sieves then, preserve standby respectively; Step 2: take by weighing meloxicam by recipe quantity, take by weighing filler and disintegrating agent and the effervescent partly measured by accessory formula, and with its abundant mix homogeneously; Step 3: with the mixed uniformly component of step 2, adopt wet granulation, under 40~50 ℃ temperature, dry granulate then; Step 4: in the granule that step 3 makes, add the disintegrating agent of surplus and other adjuvants in effervescent and the accessory formula, fully mix homogeneously; Step 5: the granule of step 4 mix homogeneously is sent into tablet machine, carry out tabletting. Xie, claims 1-2. 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 including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising one or more of the water-soluble alkalizing agents, and 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 including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising one or more of the water-soluble alkalizing agents, and wherein the composition provides a mean meloxicam Tmax about 15 minutes less than the mean Tmax provided by conventional meloxicam tablets 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 including one or more water-soluble alkalizing agents, wherein the meloxicam is embedded in alkaline surroundings comprising one or more of the water-soluble alkalizing agents, 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. Xie clearly teaches “meloxicam orally disintegrating tablets” (Xie, claim 1), WHEREBY it is noted: “principal agent,” i.e., “meloxicam” (Xie, claim 1) is “meloxicam” of claims 1, 13 and 16; “F, sodium bicarbonate” (Xie, claim 1) is encompassed by “one or more alkalizing agents” of claims 1, 13 and 16, and “sodium bicarbonate” of claims of 8-9 and 19-20: 9. ([…]) The solid oral pharmaceutical composition of claim 2, wherein the water-soluble 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. […] 20. ([…]) The solid oral pharmaceutical composition of claim 17, wherein the water-soluble 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. wherein the “meloxicam orally disintegrating tablets” (Xie, claim 1) are obtainable by a “raw material pulverizing, weighing mixing, granulation, sheeting process” (Xie, claim 2), and therefore, “meloxicam” and “F, sodium bicarbonate” (Xie, claim 1) are processed into the same granules, thereby meeting the requirements of claims 1, 13 and 16 for “alkaline surroundings,” “wherein the meloxicam is embedded in alkaline surroundings comprising one or more of the water-soluble alkalizing agents.” However, Xie’s “meloxicam orally disintegrating tablets” contain “meloxicam” as a “principal agent,” in an amount of “principal agent 3~15%” (Xie, claim 1) and therefore, Xie DOES NOT EXPRESSLY TEACH 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 Xie’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 dosage size, Xie teaches exemplary embodiments for obtaining tablets of 100.5 mg (Xie, p. 4, ln. 9, Embodiment 1), 108 mg (Xie, p. 4, ln. 41, Embodiment 2) and 101.5 mg (Xie, p. 5, ln. 20, Embodiment 3). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to formulate Xie’s “meloxicam orally disintegrating tablets” containing 3 to 15 wt.% “meloxicam” as a “principal agent” “principal agent 3~15%” (Xie, claim 1) per Xie’s broader disclosure, as a 100.5 mg table (Xie, p. 4, ln. 9, Embodiment 1) containing to 3.0 to 15.1 mg “meloxicam.” 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 Xie teaches the structure of the instant composition, as discussed above, then it reasonably follows that Xie’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 conventional meloxicam tablets 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 measured as area under a plasma concentration-time curve (AUC) in healthy adult humans under fasting condition that is not more than about 20% of the bioavailability provided by conventional meloxicam tablets 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 conventional meloxicam tablets 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 measured as area under a plasma concentration-time curve (AUC) in healthy adult humans under fasting conditions that is not more than about 20% of the mean bioavailability provided by conventional meloxicam tablets 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. Thus, Xie renders 1-4, 9, 13-14, 16-18 and 20 obvious. Regarding claims 10-12 and 21-24 and the requirements: 10. ([…]) The solid oral pharmaceutical composition of claim 2, 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 poloxamer 407, 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 poloxamer 407, 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 comprising copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, or poloxamer 407, 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 are selected from copovidone, hypromellose, povidone, hydroxy propyl cellulose, hydroxy ethyl cellulose, PEG 6000, PEG 8000, PEG 20000, and poloxamer 407, and any combination thereof. Xie’s Xie’s “meloxicam orally disintegrating tablets” contain “D, low-substituted hydroxypropyl cellulose” (Xie, claim 1), which is encompassed by “hydroxy propyl cellulose” of claims 11-12, 22 and 24, and “one or more hydrophilic polymers” of claims 10-12 and 21-24. Thus, Xie renders claims 10-12 and 21-24 obvious. Regarding claims 33-36 and the requirements: 33. ([…]) The composition of claim 2, wherein the alkalizing agent or agents are present in an amount of less than about 400 mg. 34. ([…]) The composition of claim 3, wherein the alkalizing agent or agents are present in an amount of less than about 400 mg. 35. ([…]) The composition of claim 17, wherein the alkalizing agent or agents are present in an amount of less than about 400 mg. 36. ([…]) The composition of claim 18, wherein the alkalizing agent or agents are present in an amount of less than about 400 mg. Since it would be obvious to formulate Xie’s “meloxicam orally disintegrating tablets” (Xie, claim 1) per Xie’s broader disclosure, as a 100.5 mg table (Xie, p. 4, ln. 9, Embodiment 1), as discussed above, one would be further motivated to incorporate “F, sodium bicarbonate 0.5 ~ 5%” (Xie, claim 1), i.e., 0.5 to 5.0 mg sodium bicarbonate. See MPEP § 2144.05 (I) regarding the obviousness of prior art overlapping claimed numerical ranges; see also MPEP § 2123 [R-5] regarding the obviousness of rearranging a reference according to the teachings of that same reference. Thus, Xie renders claims 33-36 obvious. Summary/Conclusion Claims 1-4, 9-14, 16-18, 20-24 and 33-36 are rejected. No claims are allowed. Applicant’s amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /DOMINIC LAZARO/Primary Examiner, Art Unit 1611
Read full office action

Prosecution Timeline

Jul 30, 2025
Application Filed
Jan 02, 2026
Non-Final Rejection mailed — §103, §112
Apr 02, 2026
Response Filed
Apr 30, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
63%
Grant Probability
94%
With Interview (+31.3%)
3y 2m (~2y 4m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 651 resolved cases by this examiner. Grant probability derived from career allowance rate.

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