DETAILED ACTION
Receipt is acknowledged of applicant’s Preliminary Amendment filed December 16, 2024.
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 .
Status of the Claims
Claims 3-9 and 12-22 have been amended. No claims were cancelled or newly added. Accordingly, claims 1-22 remain pending in the application.
Information Disclosure Statement
The IDS’s dated May 12, 2025 and May 5, 2026 have been considered. Signed copies are enclosed herewith.
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.
Claims 1, 2, 7, 9, 10-16 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Karpukhin et al. (WO 2021/037874 A1, Mar. 4, 2021, hereafter as “Karpukhin”).
The claimed invention of claims 1-9 is drawn to an oral tablet comprising: naproxen sodium; mannitol; a superdisintegrant; and a lubricant, wherein the oral tablet does not comprise a glidant.
The claimed invention of claims 10-22 is drawn to a naproxen sodium tablet formed by the process of: mixing naproxen sodium, mannitol, a superdisintegrant, and a lubricant in a continuous in-line mixer to form a tableting mixture; transferring the tableting mixture to a tablet press; and pressing the tableting mixture into naproxen sodium tablets.
Regarding instant claims 1, 2 and 7, Karpukhin teaches an oral tablet (oral tablet; page 3, lines 6-9; page 14, line 30) comprising: naproxen sodium (naproxen sodium; page 15, line 8); mannitol (mannitol; page 14, lines 30-32); a superdisintegrant (sodium starch glycolate (superdisintegrant); page 15, lines 1-2); and a lubricant (magnesium stearate; page 15, lines 2-4), wherein the oral tablet does not comprise a glidant (oral tablet does not contain a glidant; page 3, lines 6-9; page 14, line 30 - page 15, line 11).
Karpukhin does not teach a particular embodiment combining each of the claimed elements, however Karpukhin teaches a finite grouping of diluents, disintegrants, and lubricants. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the particular diluent, mannitol, the particular disintegrant, sodium starch glycolate, and the particular lubricant, magnesium stearate with a reasonable expectation of success because Karpukhin teaches a finite grouping of each category and it is not inventive to discover the optimum combination of disclosed diluents, disintegrants, and lubricants.
Regarding instant claim 9, Karpukhin teaches the elements discussed above. Karpukhin teaches a particular embodiment comprising 220 mg naproxen sodium (paragraph bridging pages 10-11 and page 20, lines 31-32).
Regarding instant claims 10, 15 and 16, Karpukhin teaches the elements discussed above. Karpukhin also teaches the steps of mixing and compressing the mixture into tablets (page 22). While Karpukhin does not explicitly teaches a continuous in-line mixer, it is noted that claim 10 and its depending claims 11-22 are deemed product-by-process claims due to the limitation, “formed by the process of...” and as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). As discussed above, Karpukhin suggests a naproxen sodium tablet comprising mannitol, sodium starch glycolate and magnesium stearate. Accordingly, Karpukhin suggests the claimed product.
Regarding instant claim 11, Karpukhin teaches the elements discussed above. The claim recites, “wherein the process does not include a granulation step”. While Karpukhin is silent to said limitation, the claim is deemed a product-by-process claim due to the limitation, “the process does not include a granulation step” and as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). The claim does not further limit the product, only the method in which it is made and, as such, Karpukhin meets the limitations of the claim.
Regarding instant claim 12, Karpukhin teaches the elements discussed above. The claim recites the limitation, mixing in a continuous in-line mixer comprises feeding the ingredients to the in-line mixer through a loss-in-weight feeder. While Karpukhin is silent to said limitation, the claim is deemed a product-by-process claim due said limitation and, as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). The claim does not further limit the product, only the method in which it is made and, as such, Karpukhin meets the limitations of the claim.
Regarding instant claim 13, Karpukhin teaches the elements discussed above. The claim recites, “mixing the naproxen sodium, the mannitol, and the superdisintegrant prior to adding the lubricant to the in-line mixer”. While Karpukhin is silent to said limitation, the claim is deemed a product-by-process claim due to said limitation and, as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). The claim does not further limit the product, only the method in which it is made and, as such, Karpukhin meets the limitations of the claim.
Regarding instant claim 14, Karpukhin teaches the elements discussed above. The claim recites, “wherein transferring the tableting mixture to a tablet press comprises vacuuming transferring”. While Karpukhin is silent to said limitation, the claim is deemed product-by-process claims due said limitation and, as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). The claim does not further limit the product, only the method in which it is made and, as such, Karpukhin meets the limitations of the claim.
Regarding instant claim 22, Karpukhin teaches the elements discussed above. Karpukhin teaches a particular embodiment comprising 220 mg naproxen sodium (paragraph bridging pages 10-11 and page 20, lines 31-32).
Thus, the teachings of Karpukhin render the instant claims prima facie obvious.
Claims 3-7 and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Karpukhin et al. (WO 2021/037874 A1, Mar. 4, 2021, hereafter as “Karpukhin”), as applied to claims 1 and 10, in view of Kamath et al. (WO 2021/127546 A1, June. 24, 2021, hereafter as “Kamath”).
The claimed invention is described above.
Karpukhin teaches the elements discussed above.
Karpukhin is silent to 70-80% naproxen sodium (instant claims 3 and 17).
Kamath teaches naproxen sodium tablet formulations comprising 220 mg of naproxen sodium or 70-80% naproxen sodium (abstract; [0050]-[0051]).
Both references are drawn to naproxen sodium tablet formulations for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include naproxen sodium in an amount of 70-80% of the tablet formulation of Karpukhin, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that including naproxen sodium in a tablet formulation in an amount of 70-80% is suitable for formulating oral tablets comprising naproxen sodium. In addition, MPEP 2144.05 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”.
Karpukhin is silent to 15-25% mannitol (instant claims 4 and 18).
Kamath teaches naproxen sodium tablet formulations comprising 5-40% w/w, 5-30% w/w, 5-20% w/w, 10-40% w/w, 10-30% w/w, 10-20% w/w, 15-40% w/w, 15-30% w/w, or 15-20% w/w mannitol (abstract; [0081]).
Both references are drawn to naproxen sodium tablet formulations for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of mannitol in the tablet formulation of Karpukhin by way of routine experimentation, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that including mannitol in a tablet formulation in an amount of 5-40% w/w, 5-20% w/w, 10-40% w/w, 10-30% w/w, 10-20% w/w, 15-40% w/w, 15-30% w/w, or 15-20% w/w is suitable for formulating oral tablets comprising naproxen sodium and it is not inventive to discover within the prior art’s disclosed range(s), the optimal range(s). In addition, MPEP 2144.05 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”.
Karpukhin is silent to 3-8% superdisintegrant (instant claims 5 and 19).
Kamath teaches naproxen sodium tablet formulations comprising 1-10% w/w, 1-7% w/w, 1-5% w/w, 1-3% w/w, 2-10% w/w, 2-8% w/w, 2-6% w/w, 2-4% w/w, 3-10% w/w, 3-9% w/w, 3-7% w/w, 3-5% w/w, 4-10% w/w, 4-8% w/w, 4- 6% w/w, or 4-5% w/w sodium starch glycolate (a disintegrant) (abstract; [0083]).
Both references are drawn to naproxen sodium tablet formulations for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of a disintegrant such as sodium starch glycolate in the tablet formulation of Karpukhin by way of routine experimentation, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that including a disintegrant such as sodium starch glycolate in a tablet formulation in an amount of 1-10% w/w, 1-7% w/w, 1-5% w/w, 1-3% w/w, 2-10% w/w, 2-8% w/w, 2-6% w/w, 2-4% w/w, 3-10% w/w, 3-9% w/w, 3-7% w/w, 3-5% w/w, 4-10% w/w, 4-8% w/w, 4- 6% w/w, or 4-5% w/w is suitable for formulating oral tablets comprising naproxen sodium and it is not inventive to discover within the prior art’s disclosed range(s), the optimal range(s). In addition, MPEP 2144.05 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”.
Karpukhin is silent to 1-6% lubricant (instant claims 6 and 20) and the particular lubricant, stearic acid (instant claim 7).
Kamath teaches naproxen sodium tablet formulations comprising a lubricant such as stearic acid or magnesium stearate in amounts of 0.1-10% w/w, 0.1-7% w/w, 0.1-5% w/w, 0.1-2% w/w, 0.5-10% w/w, 0.5-7% w/w, 0.5-5% w/w, 0.5-2% w/w, 1-10% w/w, 1-7% w/w, 1-5% w/w, or 1-2% w/w (abstract; [0062]-[0063] and [0085]).
Both references are drawn to naproxen sodium tablet formulations for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to either substitute magnesium stearate for stearic acid or combine magnesium stearate and stearic acid in the tablet formulation of Karpukhin, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that magnesium stearate and stearic acid are functional equivalents, that is, known lubricants used in tablet formulations. It is prima facie obvious to substitute and combine equivalents known for the same purpose (MPEP 2144.06).
Additionally, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of a lubricant such as stearic acid or magnesium stearate in the tablet formulation of Karpukhin by way of routine experimentation, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that including a lubricant such as stearic acid or magnesium stearate in a tablet formulation in an amount of 0.1-10% w/w, 0.1-7% w/w, 0.1-5% w/w, 0.1-2% w/w, 0.5-10% w/w, 0.5-7% w/w, 0.5-5% w/w, 0.5-2% w/w, 1-10% w/w, 1-7% w/w, 1-5% w/w, or 1-2% w/w is suitable for formulating oral tablets comprising naproxen sodium and it is not inventive to discover within the prior art’s disclosed range(s), the optimal range(s). In addition, MPEP 2144.05 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”.
Thus, the combined teachings of Karpukhin and Kamath render the instant claims prima facie obvious.
Claims 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Karpukhin et al. (WO 2021/037874 A1, Mar. 4, 2021, hereafter as “Karpukhin”), as applied to claims 1 and 10, in view of Park et al. (US 2014/0364513 A1, Dec. 11, 2014, hereafter as “Park”).
The claimed invention is described above.
Karpukhin teaches the elements discussed above. Karpukhin also teaches that naproxen sodium has poor flowability (page 25, lines 15-21).
Karpukhin is silent to spray-dried mannitol.
Park teaches an oral formulation which disintegrates quickly in tablet form (abstract). Park teaches spray-dried mannitol has various applications in the pharmaceutical art due to its properties of stable, non-hygroscopic, good taste, fast disintegration, good flowability and good compressibility and is mainly used as a diluent in direct tableting without manufacturing granules ([0031]-[0032]). Park additionally teaches naproxen as a suitable active ingredient that can be incorporated in the tablet ([0068] and [0073]).
Both references are drawn to tablets for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include spray-dried mannitol in the invention of Karpukhin, as suggested by Park, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches spray-dried mannitol is suitable for oral tablet formulations comprising naproxen sodium due to its many beneficial properties. A skilled artisan would have also been motivated because the prior art teaches naproxen sodium has poor flowability and spray-dried mannitol has good flowability, thereby, providing improved flowability in a naproxen sodium tablet formulation.
Thus, the combined teachings of Karpukhin and Park render the instant claims prima facie obvious.
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 10-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 17/786,728 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the instant claims and the subject matter of the copending claims are significantly overlapping.
The instant claims are drawn to a naproxen sodium tablet formed by the process of: mixing naproxen sodium, mannitol, a superdisintegrant, and a lubricant in a continuous in-line mixer to form a tableting mixture; transferring the tableting mixture to a tablet press; and pressing the tableting mixture into naproxen sodium tablets.
The copending claims are drawn to naproxen sodium tablet, comprising: roller-compacted granules comprising: naproxen sodium; and intragranular excipients comprising: mannitol; colloidal silicon dioxide; one or more lubricants; and one or more superdisintegrants, wherein the tablet comprises 60-80% w/w naproxen sodium, wherein the tablet has a dissolution profile wherein at least 80% naproxen sodium is dissolved at 10 minutes and at least 95% naproxen sodium is dissolved at 20 minutes as determined by the USP apparatus-2 Dissolution Test in phosphate buffer pH 7.4 at 37°C ± 0.5°C and methods of using thereof. The copending claims are also drawn to a bilayer naproxen sodium tablet, comprising: a naproxen sodium layer, comprising: granules, comprising naproxen sodium; mannitol; colloidal silicon dioxide; sodium starch glycolate; starch and/or partially pregelatinized starch; stearic acid or magnesium stearate; and croscarmellose sodium, and an acetaminophen layer, comprising: acetaminophen; colloidal silicon dioxide; starch and/or partially pregelatinized starch; stearic acid or magnesium stearate, and croscarmellose sodium, wherein the tablet has a disintegration time of less than 5 minutes as determined by the USP Disintegration Test in water using a basket-rack assembly with disks at 37°C ± 0.5°C; and methods of using thereof. The copending claims further recite, wherein the naproxen sodium tablet comprises a total amount of 10-20% w/w mannitol and wherein the naproxen sodium tablet further comprises mannitol, sodium starch glycolate, and magnesium stearate as extragranular excipients.
It is noted that the instant claims are deemed product-by-process claims due to the limitation, “formed by the process of...” and the like and as such, determination of patentability is based on the product itself, not by the method in which it is made. 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 (MPEP 2113). The copending claims are drawn to a naproxen sodium tablet comprising mannitol, one or more superdisintegrants, e.g., sodium starch glycolate and one or more lubricants, e.g., magnesium stearate and stearic acid. Accordingly, the copending claims meet the limitations of the instantly claimed product and, as such, the subject matter of the instant claims is unpatentable over the subject matter of the copending claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19, 20 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 17/786,728 (reference application), as applied to claim 10 above, in view of Kamath et al. (WO 2021/127546 A1, June. 24, 2021, hereafter as “Kamath”).
The claimed invention is described above.
The copending claims recite the elements discussed above.
The copending claims are silent to 3-8% superdisintegrant (instant claim 19).
Kamath teaches naproxen sodium tablet formulations comprising 1-10% w/w, 1-7% w/w, 1-5% w/w, 1-3% w/w, 2-10% w/w, 2-8% w/w, 2-6% w/w, 2-4% w/w, 3-10% w/w, 3-9% w/w, 3-7% w/w, 3-5% w/w, 4-10% w/w, 4-8% w/w, 4- 6% w/w, or 4-5% w/w sodium starch glycolate (a disintegrant) (abstract; [0083]).
Both the copending claims and Kamath are drawn to naproxen sodium tablet formulations for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of a disintegrant such as sodium starch glycolate in the copending tablet formulation by way of routine experimentation, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that including a disintegrant such as sodium starch glycolate in a tablet formulation in an amount of 1-10% w/w, 1-7% w/w, 1-5% w/w, 1-3% w/w, 2-10% w/w, 2-8% w/w, 2-6% w/w, 2-4% w/w, 3-10% w/w, 3-9% w/w, 3-7% w/w, 3-5% w/w, 4-10% w/w, 4-8% w/w, 4- 6% w/w, or 4-5% w/w is suitable for formulating oral tablets comprising naproxen sodium and it is not inventive to discover within the prior art’s disclosed range(s), the optimal range(s). In addition, MPEP 2144.05 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”.
The copending claims are silent to 1-6% lubricant (instant claim 20).
Kamath teaches naproxen sodium tablet formulations comprising a lubricant such as stearic acid or magnesium stearate in amounts of 0.1-10% w/w, 0.1-7% w/w, 0.1-5% w/w, 0.1-2% w/w, 0.5-10% w/w, 0.5-7% w/w, 0.5-5% w/w, 0.5-2% w/w, 1-10% w/w, 1-7% w/w, 1-5% w/w, or 1-2% w/w (abstract; [0062]-[0063] and [0085]).
Both the copending application and Kamath are drawn to naproxen sodium tablet formulations for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the amount of a lubricant such as stearic acid or magnesium stearate in the tablet formulation of the copending application by way of routine experimentation, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that including a lubricant such as stearic acid or magnesium stearate in a tablet formulation in an amount of 0.1-10% w/w, 0.1-7% w/w, 0.1-5% w/w, 0.1-2% w/w, 0.5-10% w/w, 0.5-7% w/w, 0.5-5% w/w, 0.5-2% w/w, 1-10% w/w, 1-7% w/w, 1-5% w/w, or 1-2% w/w is suitable for formulating oral tablets comprising naproxen sodium and it is not inventive to discover within the prior art’s disclosed range(s), the optimal range(s). In addition, MPEP 2144.05 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”.
The copending claims are silent to 220 mg of naproxen sodium (instant claim 22).
Kamath teaches naproxen sodium tablet formulations comprising 220 mg of naproxen sodium (abstract; [0050]-[0051]).
The copending claims and Kamath are drawn to naproxen sodium tablet formulations for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include naproxen sodium in an amount of 220 mg in the copending tablet formulation, as suggested by Kamath, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches that including naproxen sodium in a tablet formulation in an amount of 220 mg is suitable for formulating oral tablets comprising naproxen sodium. In addition, MPEP 2144.05 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”.
Thus, the subject matter of the instant claims is unpatentable over the subject matter of the copending claims in view of Kamath.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 21 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 17/786,728 (reference application), as applied to claim 10 above, in view of Park et al. (US 2014/0364513 A1, Dec. 11, 2014, hereafter as “Park”).
The claimed invention is described above.
The copending claims recite the elements discussed above.
The copending claims are silent to spray-dried mannitol (instant claim 19).
Park teaches an oral formulation which disintegrates quickly in tablet form (abstract). Park teaches spray-dried mannitol has various applications in the pharmaceutical art due to its properties of stable, non-hygroscopic, good taste, fast disintegration, good flowability and good compressibility and is mainly used as a diluent in direct tableting without manufacturing granules ([0031]-[0032]). Park additionally teaches naproxen as a suitable active ingredient that can be incorporated in the tablet ([0068] and [0073]).
Both the copending claims and Park are drawn to tablets for oral administration, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include spray-dried mannitol in the copending invention, as suggested by Park, with a reasonable expectation of success. A skilled artisan would have been motivated to do so because the prior art teaches spray-dried mannitol is suitable for oral tablet formulations comprising naproxen sodium due to its many beneficial properties.
Thus, the subject matter of the instant claims is unpatentable over the subject matter of the copending claims in view of Park.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
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/CASEY S HAGOPIAN/Examiner, Art Unit 1617
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