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 .
Claim Status
Applicants’ amendments and arguments filed 11/24/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 3, 6-7, 14, 22-26, 28-32, and 34 are canceled.
Claims 1-2, 4-5, 9, 11-12, and 15-18 have been amended.
Claims 9-13, 15-21, and 33 remain withdrawn.
Claims 1-2, 4-5, 8, and 27 are examined on the merits.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/23/2025, 11/11/2025, 12/30/2025, and 02/27/2026 are being considered by the examiner.
New Rejections Necessitated by Claim Amendments
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.
Claim(s) 1-2, 4-5, 8 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Hughey et al. (US10478429B2, published 11/19/2019, hereafter Hughey).
Hughey claims a controlled release oral pharmaceutical composition comprising one or more active pharmaceutical ingredients, about 35% to about 70% by mass glyceryl monolinoleate, and about 20 to about 50% by mass polyethylene oxide having an average molecular weight (Mv) of about 1,000,000 to about 7,000,000 (claim 1; according to the claim limitations of the instant claims 1, 5, 8, and 27). Hughey teaches one aspect of the of the composition further comprises water (column 4, lines 30-31; according to the claim limitations of the instant claim 1). Claim 8 of Hughey claims the concentration of the one or more active pharmaceutical ingredients to be about 1-30% by mass (according to the claim limitations of the instant claims 1-2). Hughey teaches using a hydrophilic vehicle, such as polyethylene glycol, as a carrier that has a high degree of miscibility with the polyethylene oxide (column 25, lines 58-62; according to the claim limitations of the instant claim 7). Hughey teaches oxycodone as an active pharmaceutical ingredient (column 3, lines 27-29; according to the claim limitations of the instant claims 1-2). Finally, Hughey provides the following abuse deterrent controlled release matric example formulations: formulation 4 comprising 60% polyethylene glycol 600, 8% polyethylene glycol 1000, 10.7% polyethylene oxide (WSR 301), 10.7% polyethylene oxide (WSR 303), and 9% oxycodone; formulation 5 comprising 57.6% polyethylene glycol 600, 7.6% polyethylene glycol 1000, 9.6% polyethylene oxide (WSR 301), 9.6% polyethylene oxide (WSR 303), and 8.6% oxycodone; formulation 6 comprising 60% polyethylene glycol 600, 8% polyethylene glycol 1000, 10.7% polyethylene oxide (WSR 303), and 9% oxycodone (column 66, table 7; according to the claim limitations of the instant claims 1-2, 4-5, 8, and 27).
Hughey does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Hughey with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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. A person of ordinary skill in the art who is not an automaton is capable of producing the composition of the instant claims with predictable results.
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 1-2, 4-5, 8, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-10, 49, and 54 of copending Application No. 18/031,669 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
18/031,669 claims a modified release softgel capsule comprising (a) a controlled release fill composition comprising: (i) at least one active agent and (ii) a controlled release material (claim 1; according to the claim limitations of the instant claim 1). Claim 2 of 18/031,669 claims the controlled release material to comprise polyethylene oxide and claim 3 of 18/031,669 claims the controlled release material comprises polyethylene oxide having a number average molecular weight of from about 0.05M Dation to about 15M Daltons (according to the claim limitations of the instant claims 1 and 5). Claim 6 of 18/031,669 claims the controlled release material is present in the controlled release fill composition in an amount of at least about 8wt% and up to about 65wt% based on a total weight of the controlled release fill composition (according to the claim limitations of the instant claims 1, 3, 8, and 27). Claim 7 of 18/031,669 claims the controlled release fill composition further comprises (iii) a hydrophilic carrier having a number average molecular weight of from about 200 Daltons to about 5000 Daltons (according to the claim limitations of the instant claim 1). Claim 8 of 18/031,669 claims the hydrophilic carrier comprising polyethylene glycol, propylene glycol, water, or a combination thereof (according to the claim limitations of the instant claim 1). Claim 9 of 18/031,669 claims the hydrophilic carrier is present in the controlled release fill composition in an amount of about 5 wt% to about 60 wt% based on the total weight of the controlled release fill composition (according to the claim limitations of the instant claims 1, 4, and 27). Claim 10 of 18/031,669 claims the at least one active agent is present in the controlled release fil composition in an amount of about 5 wt% to about 60 wt % based on the total weight of the controlled release fill composition (according to the claim limitations of the instant claim 2). Claim 49 of 18/031,669 claims a modified release softgel capsule comprising (a) a controlled release fill composition comprising (i) at least one active agent (ii) a polyethylene oxide having a number average molecular weight of from about 0.05M Dalton to about 15M Dalton, and (iii) optionally a hydrophilic carrier (according to the claim limitations of the instant claims 1 and 5). Lastly, claim 54 of 18/031,669 claims a modified release softgel capsule comprising (a) a controlled release fill composition comprising (i)at one active agent and (ii) a controlled release material (according to the claim limitations of the instant claim 1).
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reponses to Applicant’s Arguments
Applicant’s arguments filed on 11/24/2025 have been considered by the examiner.
In regards to the Election/Restriction requirement, Applicant again argues that Hughey et al. does not teach the newly amended common technical feature of a controlled release capsule fill composition comprising: i) an active pharmaceutical ingredient; ii) 21.5 wt.% to 65 wt.% of polyethylene oxide have a number average molecular weight of from 0.05 M daltons to 15 daltons, based on a total weight of the controlled release capsule fill composition; and iii) a polyethylene glycol having a number average molecular weight of from 50 daltons to 5000 daltons.
As outlined in the previous office action and reiterated here, unity was broken based off of the originally filed claims. Furthermore, Hughey et al found in the restriction office action mailed 06/12/2025, found in the 35 U.S.C. 102(a)(2) rejection of the previous non-final rejection office action mailed 08/26/2025, and found below in the 35 U.S.C. 103 rejection teaches the new amendments.
Therefore, Examiner is not persuaded by Applicant’s arguments and the requirement is still deemed proper.
In regards to the 35 USC § 102(a)(2) rejection, Applicant references Hughey specifically the example formulations, arguing the formulations do not teach a concentration of polyethylene oxide that includes or exceeds 21.4 wt% as required by the instant claim 1. Additionally, Applicant argues against Hughey by quoting Hughey and claiming it is teaching away from the combination of polyethylene oxide and polyethylene glycol as the combination yields highly viscous compositions at room temperature which impedes manufacturability and further processing. Lastly, Applicant pulls one graph figure, Figure 6, from Hughey and argues the figures demonstrates that formulations 4-6 were inferior due to their relatively poor abuse-resistant properties when compared to the standard.
In regards to Applicant’s argument that the formulations do not teach the concentrations of polyethylene oxide as in the instant claim 1, it is noted that the new rejection of record is a 35 USC § 103 rejection. As outlined above and reiterated here, a reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[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. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results. As noted in the 35 USC § 103 rejection, Hughey claims the composition comprises about 20% to about 50% by mass polyethylene oxide having an average molecular weight (Mv) of about 1,000,000 to about 7,000,000 (claim 1), thus teaching the concentration of polyethylene oxide in the instant claim 1.
In regards to Applicant’s argument that Hughey teaches away from the combination of polyethylene oxide and polyethylene glycol, it is noted that this statement is part of a paragraph which is discussing the motivation to add one or more flowability enhancers. Specifically, as quoted by Applicant the full paragraph of Hughey states “It was found that the addition of one or more flowability enhancers such as mono- or di-glycerides (e.g., Capmul® MCM), oleic acid, and glyceryl monolinoleate (e.g., Maisine™ 35-1) increases the flowability of the one or more release modifiers (e.g., high molecular weight polyethylene oxide), and thus, provides for a flowable matrix suitable for encapsulation in the soft or hard capsule shells as described herein. For example, using a conventional hydrophilic vehicle, such as polyethylene glycol, it was demonstrated that a carrier comprising polyethylene glycol had a high degree of miscibility with the high molecular weight polyethylene oxide. The resulting mixtures of polyethylene oxide and polyethylene glycol became highly viscous at room temperature, which complicates further processing steps. Further, it was found that certain oils and lipophilic vehicles are not suitable as a flowability enhancer for the one or more release modifiers.” (column 25, lines 51-67). Hughey is teaching the addition of one of more flowability enhancers increases the flowability of release modifiers such as polyethylene oxide as opposed to previous compositions such as polyethylene oxide and polyethylene glycol alone. Therefore, Hughey is not teaching away from the combination of polyethylene oxide and polyethylene glycol, but in contrast is teaching against the combination alone. As mentioned above and reiterated here, A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Further, it is noted that the instant claims utilize the transitional term “comprising” which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps per the MPEP 2111.03(I). Thus, the instant claims do not exclude the addition of one or more flowability enhancers such as glyceryl monolinoleate.
In regards to Applicant’s argument that FIG. 6 of Hughey teaches the formulations 4-6 are inferior to the standard, it is first noted that Hughey does not teach the formulations being “inferior” to the standard, but merely teaches the formulations having a quicker rate of release in specific conditions, aqueous conditions at 80oC (column 13, lines 52-55). Further, it is noted that Applicant’s instant claims are not directed towards a specific release profile, but broadly claim “a controlled release”. Additionally, it is noted that Hughey’s FIG. 7 demonstrates the formulations have a slower rate of release in FASSGF and FASSIF buffer (column 13, lines 56-60). As mentioned above and reiterated here, A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Further for a composition claim it is immaterial as to whether it is preferred or not rather the prior art reference is enabled for all that it teaches even non-preferred embodiments and as such its teachings overlap with the instant claimed composition as outlined above.
In summary, the previous rejections of record are withdrawn due to claim amendments and new grounds of rejection are seen above in the 35 USC § 103 rejection.
In regards to the Double Patenting rejection, Applicant has provided no argument or reasoning as to why the rejection should be withdrawn. Therefore, the rejection is maintained and updated for amendments.
Conclusion
No claims 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 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 ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611