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 Claims
The amendments and arguments filed on 12/05/2025 are acknowledged and have been fully considered. Claims 113,115,117,119-135,138, and 141 are pending. Claims 113,117, and 119 have been amended. Claims 129-131 and 134-135 have been withdrawn. Claims 1-112, 114, 116, 118, 136-137, 139-140, and 142-143 have been canceled. Applicants’ amendments are supported by the originally filed disclosure.
No new matter has been added.
Thus, claims 113,115,117,119-128, 132-133, 138, and 141 will be examined on the merits herein.
Claim Rejections - 35 USC § 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 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.
Claim(s) 113,115,117,119-128, 132-133, and 141 are rejected under 35 U.S.C. 103 as being unpatentable over Guillard et al (US 20030211145 A1).
Guillard discloses pharmaceutically acceptable and stable compositions (see entire document, for instance, abstract). Guillard teaches composition comprising a) from 35 to 75% by weight ibuprofen, b) from 1 to 10% by weight alkali hydroxide, and c) from 15 to 55% by weight of an emulsifier selected from sorbitan esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearates, or mixtures thereof (see entire document, for instance [0028]- [0035]). Guillard teaches alkali hydroxide is used in an amount of from 1 to 10% by weight, preferably 1 to 5% by weight (see entire document, for instance, [0039]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05). Therefore, it would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. In the instant case the ranges taught by Guillard et al. are close to the instantly claimed ranges such that a person of ordinary skill in the art would still have been motivated to use them in the practiced pharmaceutical composition. The Examiner thus respectfully submits that a person of ordinary skill in the art would have had a reasonable expectation that it will likely be in the majority within the practiced percentages.
Guillard teaches the alkali hydroxide used as component b) in the present invention is preferably sodium hydroxide (NaOH), potassium hydroxide (KOH) or their mixture (see entire document, for instance, [0040]). The most preferred alkali hydroxide according to the invention is KOH (see entire document, for instance, [0040]). Guillard teaches preferred polyoxyethylene sorbitan fatty acid esters polysorbate 80 (see entire document, for instance, [0049]). Example 1 and 2 depict weight of composition 420mg. Guillard discloses 1-20% by weight water (see entire document, for instance, [0019]). Guillard discloses capsules for liquid filling have usually a volume of from 0.3 to 1.0 ml ([0059]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05). Therefore, it would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. In the instant case the ranges taught by Guillard et al. are close to the instantly claimed ranges such that a person of ordinary skill in the art would still have been motivated to use them in the practiced pharmaceutical composition. The Examiner thus respectfully submits that a person of ordinary skill in the art would have had a reasonable expectation that it will likely be in the majority within the practiced percentages.
Claims 113,115,117,119-128, 132-133, and 141 are rejected under Guillard. Guillard et al does not teach within a single embodiment in order to anticipate but renders obvious the instant claims. As such it would be obvious at the time the invention was filed to rearrange the components of Guillard and obtain a composition as claimed. A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of variables (for example, form), in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, "when 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.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention was made to rearrange the disclosed elements and embodiments of Guillard et al., to include an example form, to prepare the claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed compositions and methods is within the purview of the ordinary skilled artisan upon reading Guillard et al., as cited above, and would yield predictable results.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. Applicant argues, "Guillard does not disclose or suggest, at least a weight ratio of the one or more polyoxysorbitan esters to the ibuprofen being from 0.4:1 - 0.8:1 as recited in amended claim 113, or the weight ratio of the one or more polyoxysorbitan esters to the ibuprofen being from 0.5:1 - 0.7:1 as recited in claim 115... the Examples of Guillard, the ratio of emulsifier (e.g., sorbitan esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearates, or mixtures thereof) to ibuprofen is at a minimum 1:1. " The examiner respectfully disagrees. Specifically, Guillard expressly teaches active components of the composition. Guillard teaches composition comprising a) from 35 to 75% by weight ibuprofen, b) from 1 to 10% by weight alkali hydroxide, and c) from 15 to 55% by weight of an emulsifier selected from sorbitan esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearates, or mixtures thereof (see entire document, for instance [0028]- [0035]). Guillard teaches alkali hydroxide is used in an amount of from 1 to 10% by weight, preferably 1 to 5% by weight (see entire document, for instance, [0039]). As such, Applicants argument is not found persuasive. It is noted that Applicant has not articulated the criticality of the ratio. It is noted that 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.”
Claim(s) 113,115,117,119-128, 132-133, 138, and 141 are rejected under 35 U.S.C. 103 as being unpatentable over Guillard et al (US 20030211145 A1) as applied to claims 113,115,117,119-128, 132-133, and 141 above, and further in view of ROBERTS et al (US 20180071221 A1).
The teachings of Guillard et al have been set forth above. However, they do not expressly disclose including a soft gelatin capsule. ROBERTS et al remedy this deficiency.
ROBERTS discloses compositions comprising ibuprofen, ibuprofen salts, or combinations thereof, methods for making the same, and methods for treating subjects in need thereof (abstract). ROBERTS teach the bioavailability of a drug depends on several factors, including drug solubility in an aqueous environment and drug permeability through lipophilic membranes ([0003]). Orally administered drugs absorb and show good bioavailability only when they are soluble in the gastric medium ([0003]). ROBERTS teaches soft capsules have gained increased popularity and acceptance due to their elegant and clear gelatin shell ([0008]). Furthermore, soft capsules are uniform, stable, dissolve quickly, allow for liquid formulations, and are easier to swallow ([0008]). ROBERTS discloses there is an unmet need for a soft capsule immediate release ibuprofen formulation that is as fast as or faster than currently available tablet and caplet forms ([0009]). ROBERTS teaches the need for a formulation to overcome limitations of poor aqueous solubility, be highly stable, have increased bioavailability, provide rapid perceptible relief onset, and reduce plasma level variability ([0009]). Accordingly, it is desirable to develop formulations of ibuprofen sodium in soft gelatin capsules ([0009]). ROBERTS teaches pH modifying agents or neutralizing agents ([0071]). Suitable non-limiting examples of such agents include sodium hydroxide, potassium hydroxide ([0071]). ROBERTS teaches the active pharmaceutical ingredient comprise ibuprofen (see entire document, for instance [0012]). ROBERTS disclose an active pharmaceutical ingredient of about 10 mg-or about 800 mg (see entire document, for instance, [0113]- [0117]).
Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Guillard with the composition of ROBERTS et al. One would be motivated to do so with a reasonable expectation of success in applying a known technique to a known device (method, or product) ready for improvement to yield predictable results. In the instant case a pharmaceutical dosage form that is easily digested and dissolve quickly in the stomach thus allowing quicker onset of the desired pharmaceutical effect.
Claims 139-140 recites percentage of ibuprofen to be solubilized in simulated gastric fluid at a pH of 1.2. Looking to Applicants’ instant specification, the limitation appears to be a property that is tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., pg. 28, lines 1-5). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining composition is disclosed in the prior art, the recited limitation of claim 139-140, will also be considered to be met.
Response to Arguments
Applicant's arguments filed 12/05/2025 have been fully considered but they are not persuasive. Applicant's argument is not found persuasive against the grounds of rejection above. As Applicant indicates, "Roberts discloses there being an "unmet need for a soft capsule immediate release ibuprofen formulation," that the document solves." There would be a reasonable expectation of success since the references are directed to ibuprofen formulation.
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 113,115,117,119-128, 132-133, 138, and 141 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 121-144 of copending Application No. 17/999,056 in view of Guillard et al (US 20030211145 A1). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection.
The copending claims are directed to a composition comprising a composition for encapsulation in a soft gelatin shell, the composition comprising: ibuprofen; one or more polyoxysorbitan esters; and a base, wherein a weight ratio of the one or more polyoxysorbitan esters to the ibuprofen is from 0.0025:1 - 1.5:1, a weight ratio of the base to the ibuprofen is from 1:3 - 1:12, and a weight ratio of the one or more polyoxysorbitan esters to the base is 0.009:1 - 11:1.
However, the copending claims do not explicitly teach 50% - 65% w/w ibuprofen. Guillard et al remedy this deficiency.
Guillard teaches composition comprising a) from 35 to 75% by weight ibuprofen, b) from 1 to 10% by weight alkali hydroxide, and c) from 15 to 55% by weight of an emulsifier selected from sorbitan esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearates, or mixtures thereof (see entire document, for instance [0028]- [0035]). Guillard teaches alkali hydroxide is used in an amount of from 1 to 10% by weight, preferably 1 to 5% by weight (see entire document, for instance, [0039]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05). Therefore, it would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. In the instant case the ranges taught by Guillard et al. are close to the instantly claimed ranges such that a person of ordinary skill in the art would still have been motivated to use them in the practiced pharmaceutical composition. The Examiner thus respectfully submits that a person of ordinary skill in the art would have had a reasonable expectation that it will likely be in the majority within the practiced percentages. Thus, the scope of the copending claims anticipates the scope of the instant claims.
Response to Arguments
Applicants' filed arguments and amendments with regard to the nonstatutory double patenting rejections have been fully considered, but they are not persuasive.
Claims 113,115,117,119-128, 132-133, 138, and 141 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 82-90,92-93,95-97, and 100-107 of copending Application No. 17/999,073 in view of Guillard et al (US 20030211145 A1). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection.
The copending claims are directed to composition for encapsulation in a soft gelatin shell, the composition comprising: ibuprofen; one or more polyvinyl pyrrolidones; and one or more polyethylene glycols, wherein a weight ratio of the ibuprofen to the one or more polyvinylpyrrolidones is from 2:1 - 15:1, a weight ratio of the ibuprofen to the one or more polyethylene glycols is from 1:1 - 5:1, and a weight ratio of the one or more polyethylene glycols to the one or more polyvinylpyrrolidones is 2:1 - 10:1.
However, the copending claims do not explicitly teach 50% - 65% w/w ibuprofen, polyvinylpyrrolidones or polyethylene glycol. Guillard et al remedy this deficiency.
Guillard teaches composition comprising a) from 35 to 75% by weight ibuprofen, b) from 1 to 10% by weight alkali hydroxide, and c) from 15 to 55% by weight of an emulsifier selected from sorbitan esters, polyoxyethylene sorbitan fatty acid esters, polyoxyethylene stearates, or mixtures thereof (see entire document, for instance [0028]- [0035]). Guillard teaches alkali hydroxide is used in an amount of from 1 to 10% by weight, preferably 1 to 5% by weight (see entire document, for instance, [0039]). Guillard teaches the capsule shell material contains 0 to 95% pharmaceutically acceptable extenders based upon the weight of the hydrophilic polymer ([0024]). The extender may be selected from polyvinylpyrrolidone ([0024]). Guillard teaches the capsule shell material may furthermore contain 0 to 40% pharmaceutically acceptable plasticizers based upon the weight of the hydrophilic polymer ([0021]). The plasticizer which may be employed can be polyethylene glycol ([0021]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05). Therefore, it would be within the purview of the skilled artisan to manipulate amounts of components within said ranges by routine experimentation, with a reasonable expectation of success. In the instant case the ranges taught by Guillard et al. are close to the instantly claimed ranges such that a person of ordinary skill in the art would still have been motivated to use them in the practiced pharmaceutical composition. The Examiner thus respectfully submits that a person of ordinary skill in the art would have had a reasonable expectation that it will likely be in the majority within the practiced percentages. Thus, the scope of the copending claims anticipates the scope of the instant claims.
Response to Arguments
Applicants' filed arguments and amendments with regard to the nonstatutory double patenting rejections have been fully considered, but they are not persuasive.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham, can be reached at (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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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611