DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the claims and applicant arguments/remarks, filed 05/26/2026, is acknowledged.
Claims 1-7 are pending in this action. Claim 10 has been cancelled. Claims 8-9, 11-29 have been cancelled previously. Claims 1-3 have been amended. Claims 1-7 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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 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.
Priority
This application claims benefit of provisional U.S. Application No. 63/141,233, filed January 25, 2021.
Claim Rejections - 35 USC § 112(1)
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 1-7 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The newly amended independent claim 1 is directed to pharmaceutical compositions comprising a softgel capsule comprising a fill composition and a shell composition comprising sorbitol and sorbitan, and wherein said softgel capsules have a hardness of 6-13N.
In the present case, it is noted that the instant specification teaches: (i) the use of sorbitol as a plasticizer (Para. 0064), and/or as a sweetener (Para. 0067); and (ii) the use of sorbitan derivatives as a surfactant (Para. 0059, 0060). Further, it is noted that the instant specification provides the example of compounds/compositions that can be used for encompassing the fill compositions (Para. 0080), i.e., compositions including: (i) 40.7-47% of gelatin; (ii) 28.56-32.61% of water; (iii) 11.89-24.7% of “sorbitol sorbitan solution”; and (iv) 40.7% of glycerin (Para. 0080). No information is provided regarding: (i) “a shell” and/or “shell composition comprising sorbitol and sorbitan”; (ii) the composition of the “sorbitol sorbitan solution” as used in the example (Para. 0080); (iii) what compounds can be include into the fill compositions and/or should be excluded to provide specific hardness of the final softgel capsules as instantly claimed, i.e., 6-13 N. Therefore, the examiner maintains the position that the instant specification does not provide required written description of the claimed invention.
While it is recognized that adequate written description of a limitation is not required to be stated in haec verba in the specification or claims as originally filed, adequate written support for claim limitations must arise from either an explicit or implicit suggestion by the disclosure to show that such a concept as claimed was actually in possession of applicant at the time of the invention. For the reasons provided supra, applicant has failed to provide the necessary teachings, by describing the claimed invention with all of its limitations using such descriptive means that fully set forth the claimed invention, in such a way as to reasonably convey to one skilled in the relevant art that applicant had possession of the claimed invention.
Claim Rejections - 35 USC § 112(b)
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 1-7 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 the applicant regards as the invention.
Newly amended claim 1 discloses “a fill composition comprising naproxen free acid and a potassium salt of naproxen”, and further recites the limitation “wherein the potassium salt of naproxen is present in an amount corresponding to a molar ratio of potassium hydroxide to naproxen free acid of less than 1” that is unclear, because the structure of the claimed fill composition is not clearly delineated. In the present case, it is unclear if said recited molar ratio of potassium hydroxide to naproxen free acid refers to a specific preparation step, or discloses the constituents to be present in the claimed fill composition, i.e., a potassium salt of naproxen, naproxen free acid and potassium hydroxide, wherein said fill compositions may also include additional components (i.e., comprising)? As stated previously, “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel). Similar is applied to claims 2, 3. Clarification is required.
Claims 4-7 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
Claim Rejections - 35 USC § 103 - MAINTAINED
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al., US 5,360,615 (hereinafter referred to as Yu’615), in view of Yu et al., US 5,071,643 (hereinafter referred to as Yu’643), and further in view of Berthel et al., US 2003/0219477 (hereinafter referred to as Berthel), Lopez et al., US 2013/0011470 (hereinafter referred to as Lopez), and Hassan et al., US 2014/0093562 (hereinafter referred to as Hassan).
Yu’615 teaches concentrated solutions/compositions comprising an acidic pharmaceutical agent(s), e.g., naproxen (i.e., naproxen free acid), that are suitable for filling into softgel capsules (Abstract; Col. 2, Lns. 29-33; Col. 4, Lns. 26-29; Col. 6, Lns. 10-25; Examples), wherein said filling compositions comprise hydroxide species, e.g., potassium hydroxide as an ionizing agent, for increasing solubility of said acidic pharmaceutical agent (Claims 1, 4, 8; Col. 8, Lns. 16-26 as applied to claim 1). To this point, Yu’615 specifically teaches the fill compositions for softgel capsules, wherein said compositions may include: (i) a solvent system comprising 10-80 wt% of polyethylene glycol and 1-20 wt% of water; (ii) an acidic drug/naproxen (i.e., naproxen free acid); (iii) hydroxide species, e.g., potassium hydroxide as an ionizing agent; (iv) wherein the hydroxide species are present in an amount of 0.1-1 mole of hydroxide ions per mole of acidic groups in the acidic drug; and (v) wherein the acidic drug/naproxen is present in said solvent system as a free acid and a cationic salt, and further teaches that including water in a solvent system allows minimize a capsule size (Col. 4, Lns. 36-43; Table 1).
Yu’615 teaches that said filling compositions may include 20-50 wt% of naproxen, 0.2-0.9 mole of hydroxide ion per mole of naproxen (Col. 5, Lns. 16-20 and 28-33 as applied to claims 1-3), and provides example of softgel capsules having a minimum size 7, oblong shape and comprising the filling composition having the unit dosage 250 mg of naproxen, and also teaches controlling capsule size to permit easy swallowing (Col. 6, Lns. 35-48; Table 1 as applied to claims 1, 4, 6, 7).
Yu’615 does not specifically teach the use of filling compositions in an amount of 600-700 mg (claim 5).
To this point, it is noted that Yu’615 provides examples of filling compositions (500-625 mg) comprising naproxen (e.g., 250 mg), potassium hydroxide (e.g., 18.25 mg) and/or other active agents or salts thereof (Examples III-XII). Yu’615 also teaches that the dosages administered depend upon the acidic pharmaceutical agent employed, the mode of administration, the treatment desired, the size, age, and weight of the patient being treated (Col. 9, Lns. 19-29); identifying thereby said parameter as result effective variable.
Yu’643 teaches filling compositions for softgel capsules (e.g., solutions comprising 20-50 wt% of naproxen; 0.2-0.9, or 0.4-0.6 moles of hydroxide ion per mole of naproxen); and further teaches that (i) the solubility of naproxen was greater in the presence of potassium hydroxide than in the presence of sodium hydroxide, and (ii) properties of said solutions/compositions depend on concentrations of naproxen, hydroxide ion, and a solvent system, identifying thereby said parameters as result-effective variables (Abstract; Col. 4, Lns. 23-40; Col. 5, Lns. 13-17 and 25-30; Col. 8, Lns. 15-26). Yu’643 provides examples of highly concentrated filling compositions (600-625 mg) comprising 250-260 mg of naproxen, 18.25-22.5 mg of potassium hydroxide, in combination with other additives (Examples XI, XII).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare softgel capsules comprising naproxen as taught by Yu and comprising a desired naproxen dose, weight of filling compositions, and/or having a desired capsule size. One would do so with expectation of beneficial results, because Yu teaches the softgel filling compositions that (i) allow enhancement/improvement of bioavailability of the used active agents, and (ii) can be encapsulated in small capsules allowing an easy swallowing.
Though Yu’615 teaches that by selecting a proper ratio of the free pharmaceutical agent and its salt, the solubility of that agent can be maximized, identifying thereby said ratio as a result effective variable (Col. 6, Lns. 5-7), Yu’615 does not specifically teach the amounts of potassium salt of naproxen as recited in claim 1, and also does not teach softgel capsule shell comprising sorbitol and sorbitan (claim 1).
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Berthel teaches pharmaceutical formulations having increased stability and bioavailability of an active agent/drug containing a carboxylic acid function (e.g., naproxen), wherein said formulations are suitable for filling softgel capsules having desired shape and size, and wherein said filling compositions may include: (i) a therapeutically effective amount of said drug, e.g., 125-500 mg of naproxen and/or salt thereof; and (ii) an effective amount of potassium hydroxide not to exceed the molar equivalent of the carboxylic acid function (Claims 1-2, 5-7, 9; Abstract; Para. 0037, 0040, 0044, 0051, 0065). Berthel teaches that for drugs having a carboxyl acidic function, the filling composition includes 0.05-1.0 mole of hydroxide ions (e.g., originated from potassium hydroxide) for each molar equivalent of said acidic drug/naproxen (Para. 0076), identifying thereby the molar ratios of acid drug/naproxen to a hydroxide ions/potassium hydroxide as result effective variables for providing filling compositions to be used for filling softgel capsules with increased stability and increased bioavailability of an acidic agent containing a carboxylic acid function (e.g., naproxen). Berthel teaches that said capsules can be formed into desired shape and size (Para. 0085), and provides examples of filling compositions (334 mg) comprising 200 mg of naproxen and 40 mg of potassium hydroxide (Para. 0091).
Lopez teaches naproxen formulations suitable for encapsulation into soft gel capsules with increased stability, concentration and bioavailability of naproxen, wherein said formulations include: (i) naproxen and naproxen salt (e.g., naproxen sodium), and (ii) a solvent system such as polyethylene glycol, propylene glycol, povidone, and 1-10 wt% of water, in combination with other additives (Title; Abstract; Para. 0002, 0013, 0018, 0019). To this point, Lopez teaches that controlling a ratio of naproxen-to-naproxen salt/sodium (i.e., acid form and salt form of naproxen) can be used for controlling pH of filling material to ensure the compatibility of the fill material with the gel shell, which encapsulates the naproxen formulation (Para. 0022; Example 4). Lopez also teaches that the softgel capsule shell formulation may be based on gelatin or other gelling agents or their combinations suitable soft gel encapsulation, wherein said shell formulation may include suitable plasticizers, e.g., sorbitol-sorbitan solutions (Para. 0030).
Hassan teaches solid naproxen concentrates that can be formulated into softgel capsules, tablets, suspensions, etc., wherein at least 90 wt% of said solid naproxen concentrate is naproxen free acid and naproxen alkali salt (e.g., naproxen potassium) that can be present in any suitable amount, e.g., 15-85% of solid naproxen free acid and 15-85% of solid naproxen alkali salt (e.g., naproxen potassium; Title, Para. 0016-0018, 0022, 0024, 0034-0035, 0038, 0042; Examples). Hassan teaches that said naproxen concentrates (i) has improved physical properties compared to naproxen salts or naproxen free acid (Para. 0031); (ii) can be used to formulate immediate or controlled release naproxen-containing capsules (Para. 0031, 0044); (iii) can be formulated into soft shell capsules containing the equivalent of 200-500 mg of naproxen per capsule (Para. 0051). Hassan further teaches that softgel capsule shell may be plasticized with sorbitol (Para. 0041).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to control the concentrations of naproxen and naproxen salt as taught by Berthel, Lopez, and Hassan preparing filling compositions taught by Yu. One would do so with expectation of beneficial results, because the cited prior art teaches that relative concentrations of naproxen and its salts can be used for controlling solubility, stability and bioavailability of naproxen as well as pH of filling composition, and also for providing immediate/controlled release naproxen-containing capsules containing the equivalent of 200-500 mg of naproxen per capsule. It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare/use softgel capsules comprising a shell composition comprising sorbitol-sorbitan solution or sorbitol as plasticizers (and/or sweeteners), because the cited prior art teaches the encapsulation of naproxen into softgel capsules with increased stability, concentration and bioavailability (Lopez, Hassan).
Further, with regard to the concentrations of potassium salt of naproxen as instantly claimed (claim 1), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where 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.
Regarding the properties of the disclosed softgel capsules, i.e., a hardness of 6-13N, it is noted that the cited prior art teaches compositions that are substantially the same as the compositions recited by the instant claims, i.e., comprise components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. Pertinent Prior Art of record, i.e., US 2020/0309453 A1 (see below), provides a strong support to the examiner’s position. Further, it is noted that “The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2020/0309453 A1 – teaches softgel capsules (Para. 0002, 0053) that may include naproxen (i.e., naproxen free acid) or potassium salt of naproxen (Para. 0034, 0035); potassium hydroxide (Para. 0046, 0047); sorbitol (Para. 0007, 0010, 0038, 0047, 0053); sorbitan monolaurate, sorbitan monooleate, sorbitan monopalmitate, sorbitan monostearate (Para. 0037, 0047); wherein said capsules can be dried to a hardness of 8N in less than 24 hours, i.e., 13-24 hours (Para. 0058).
US 6,387,400 - teaches pharmaceutical compositions for use in soft gel formulations, wherein said formulations may include pharmaceutically active ingredient/naproxen, potassium hydroxide in combination with other additives, and allow to significantly increase the concentration of the pharmaceutically active ingredient/naproxen resulting in either a reduction in overall fill volume and dosage unit size (i.e., soft gel capsule) or an increase in concentration of pharmaceutically active ingredient per dosage form.
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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 23-25 of copending Application No. 17/594,677.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: A pharmaceutical composition comprising a softgel and a fill composition, the fill composition comprising a reaction product of naproxen free acid and potassium hydroxide, wherein a molar ratio of the potassium hydroxide to naproxen free acid is less than about 1; and wherein the softgel has a size 8 to 14; and wherein the fill composition has a weight of 200-800 mg. Further, it is noted that the specification of the referenced copending application teaches that (i) said softgel compositions may have a hardness of 2-20 N, e.g., 6-13 N (Para. 0069-0079); and also teaches (ii) the use of “sorbitol-sorbitan solution” for encompassing the fill compositions (Para. 0076). In the present case, the copending application claims are merely broader than instant claims that include additional limitation (i.e., relative concentration of naproxen potassium, sorbitan and sorbitol, a hardness) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said copending application. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 05/26/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and rejections have been added to the record to address newly introduced amendments and/or to clarify the position of the examiner. Additional examiner comments are set forth next.
In response to the applicant’s argument that the instant specification provides sufficient support for the limitation “shell composition comprising sorbitol and sorbitan” by using the term “encompassing” in Para. 0080, it is noted that the instant specification teaches several steps for formation of softgel capsules (Para. 0081-0090). No information is provided in Para. 0081-0090 regarding the encompassing the fill compositions by using solutions comprising gelatin, water, “sorbitol sorbitan solution”; and glycerin (see above) i.e., regarding the formation of shell comprising sorbitol and sorbitan. Clarification is required.
In response to applicant’s argument that the cited prior art does not teach softgel capsules having a hardness as newly claimed, i.e., 6-13N, it is noted that the cited prior art teaches filling compositions comprising the same components. Thus, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. Adding to that, as stated above, the Pertinent Prior Art of record, i.e., US 2020/0309453 A1 (see above) teaches softgel capsules that may include naproxen (i.e., naproxen free acid) or potassium salt of naproxen, potassium hydroxide, sorbitol, and sorbitan derivatives; wherein said capsules can be dried to a hardness of 8N in less than about 24 hours. Further, it is noted that an inherent feature/property needs not be recognized by one of ordinary skill in the art at the time of the invention (Schering Corp. v. Geneva Pharmaceuticals, Inc. (339 F.3d 1373, 1377, 67 U.S.P.Q.2d 1664, 1668) (Fed. Cir. 2003)). It is only required that the subject matter is, in fact, inherent in the prior art reference (Schering Corp. v. Geneva Pharmaceuticals, Inc.). Furthermore, it is noted that the fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention has been collectively taught by the combined teachings of the references. Applicant is advised to clarify the structure of the claimed compositions and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application in condition for allowance.
Conclusion
No claim is allowed at this time.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615
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