DETAILED ACTION
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
Applicant’s reply dated 09 March 2026 to the previous Office action dated 08 September 2025 is acknowledged. Pursuant to amendments therein, claims 21-43 are pending in the application.
A new rejection under 35 U.S.C. 112 is made herein in view of applicant’s claim amendments.
The rejections under 35 U.S.C. 103 made in the previous Office action is/are withdrawn in view of applicant’s claim amendments, but new (modified) rejections under 35 U.S.C. 103 are made herein in view of applicant’s claim amendments.
Claim Rejections - 35 USC § 112
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 30-32 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 30-32 depend upon claim 2 which has been canceled, and thus such claims are incomplete and therefore indefinite per MPEP 608.01(n)(V). For purposes of compact prosecution such claims are interpreted herein as depending upon claim 21.
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 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.
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 21-36 and 38-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tengler et al. (US 2014/0112996 A1; published 24 April 2014; of record).
Tengler et al. discloses oral dosage forms for prolonged therapy including various pluralities of drug-containing resin particles (title; abstract). In one embodiment, the pharmaceutical composition comprises at least one pharmaceutically active ADHD effective agent drug-resin complex providing for immediate release and at least one pharmaceutically active ADHD effective agent drug-resin complex covered with a delayed/triggered release coating and/or an extended release barrier coating (paragraphs [0018], [0094]). The ADHD effective agent may be a mixture such as 75% dextroamphetamine and 25% levoamphetamine (i.e., ratio of 3:1) (paragraphs [0019], [0155]). The resin particles may be cation exchange resins and the composition may be a liquid suspension (paragraph [0022]). Drug that is unbound may also be included in the composition (paragraph [0142]) (i.e., an immediate release component). The liquid dosage forms provide for dosage flexibility (i.e., titratable dose) and ease of swallowing and are especially preferred for pediatric use (paragraph [0132]). Acidulants may be included in amounts generally known to adjust pH (paragraph [0133]). A barrier coating should be water-insoluble and water-permeable (paragraph [0117]), and may comprise a polymer, plasticizer, and stabilizer (paragraph [0121]), and may include polyvinylacetate (i.e., pH-independent, non-ionic) (paragraph [0123]), and may comprise solvent-based ethylcellulose (i.e., pH-independent, non-ionic) (paragraph [0120]). The delayed release coating is different from a triggered-release coating which is degraded as a result of a triggering event such as a pH change (i.e., the delayed release coating is pH-independent) (paragraph [0127]). A triggered-release coating may also be pH-independent (paragraphs [0127]-[0128]). Coatings can be applied with a fluid-bed coating apparatus having the Wurster configuration (i.e., cured coatings) (paragraph [0116]). The pharmacokinetic parameters of the composition including Cmax and various AUCs may be within a range of 90-115% of the values of the same parameters for a bioequivalent reference composition such as ADDERALL XR (paragraph [0030]), and they may be adjusted by adjusting the relative amounts of coated and uncoated drug-resin particles in the composition (paragraph [0224]), and various such pharmacokinetic parameter values are provided in Tables 8-11. The composition may comprise various amounts of the different pluralities of drug-resin particles such as 20-50% of the first plurality and 50-80% of the second plurality (i.e., 20-50% of drug in the first plurality and 50-80% of drug in the second plurality and remaining 0-30% of drug unbound) (paragraph [0021]). The drug may be in salt form (paragraphs [0103], [0108]) and aspartate and sulfate are known salt forms of amphetamine (paragraph [0007]). Tengler et al. discloses many different cation exchange resins such as sodium polystyrene sulfonate that may be used in the composition (paragraphs [0096], [0098]). Unit dosages of liquid drug suspension may be for example 5, 10, 15, 30, or 60 mL (paragraph [0150]), and the effective dosage of amphetamine may range from 3.13-18.8 mg calculated as free base (paragraph [0147]). ADHD is treated by administering/delivering an effective amount of the composition to a subject wherein the amount of drug delivered is about 2-60mg per 24 hours once a day as a single or multiple unit dose (paragraph [0027]) and the composition can be therapeutically effective throughout the day (paragraph [0138]). The composition preferably comprises a suspension in aqueous vehicle, and the total water content is about 20-75% w/v (paragraph [0134]). Administration is for ages 6 to adult (paragraph [0147]). Saccharate counterion is optional and can be excluded (paragraph [0019]).
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 follow the suggestions of Tengler et al. as discussed above and to formulate a liquid suspension having the elements as discussed above and to administer it per methods as discussed above, with a reasonable expectation of success.
Regarding the claimed recitation of a lack of pH-dependent release coating, as discussed above Tengler et al. discloses pH-independent coatings.
Although Tengler et al. does not explicitly disclose all the claimed pharmacokinetic parameter value ranges and profiles and effects, 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 optimize such pharmacokinetic values and profiles and effects by varying the relative amounts of coated and uncoated drug-resin particles and unbound drug in the composition as suggested by Tengler et al. through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success.
It is also noted that a prima facie case of obviousness exists where claimed ranges overlap with or are merely close to ranges disclosed in the prior art per MPEP 2144.05(I). Moreover, differences in concentration will generally not support patentability of subject matter encompassed by the prior art absent evidence of criticality per MPEP 2144.05(II)(A).
Regarding the claimed separate cation exchange resins, 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 make the composition of Tengler et al. as discussed above using more than one cation exchange resin, thereby resulting in the different drugs and particle pluralities bound to different resins, with a reasonable expectation of success, given that Tengler et al. discloses many different cation exchange resins that may be used in the composition, and given that it is prima facie obvious to combine equivalents known for the same purpose per MPEP 2144.06(I).
Regarding the claimed aspartate and sulfate counterions, 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 make the composition of Tengler et al. as discussed above using more than one counterion, such as with aspartate and sulfate, with a reasonable expectation of success, given that Tengler et al. discloses that the drug may be in salt form and aspartate and sulfate are known salt forms of amphetamine, and given that it is prima facie obvious to combine equivalents known for the same purpose per MPEP 2144.06(I). Regarding the claimed concentrations of aspartate and sulfate counterions, as noted above, differences in concentration will generally not support patentability of subject matter encompassed by the prior art absent evidence of criticality per MPEP 2144.05(II)(A).
Regarding the claimed amounts/dosages/ratios of amphetamine, Tengler et al. discloses that unit dosages of liquid drug suspension may be for example 5, 10, 15, 30, or 60 mL as discussed above, which range of 5-60 mL encompasses the claimed 8 mL, and a prima facie case of obviousness exists where claimed ranges overlap with ranges disclosed in the prior art per MPEP 2144.05(I); and Tengler et al. discloses that the effective dosage of amphetamine may range from 3.13-18.8 mg calculated as free base, which is close to the claimed 20 mg, and a prima facie case of obviousness exists where claimed ranges are merely close to ranges disclosed in the prior art per MPEP 2144.05(I). Furthermore, differences in concentration will generally not support patentability of subject matter encompassed by the prior art absent evidence of criticality per MPEP 2144.05(II)(A).
Regarding the claimed water concentration ranges, although Tengler et al. discloses total water content is about 20-75% w/v, such range is believed to overlap the claimed ranges of in excess of 50% w/w and about 60-90% w/w given that the composition of Tengler et al. as discussed above is an aqueous suspension and thus w/v and w/w amounts are about the same, and a prima facie case of obviousness exists where claimed ranges overlap with ranges disclosed in the prior art per MPEP 2144.05(I), and a prima facie case of obviousness exists where claimed ranges are merely close to ranges disclosed in the prior art per MPEP 2144.05(I). Furthermore, differences in concentration will generally not support patentability of subject matter encompassed by the prior art absent evidence of criticality per MPEP 2144.05(II)(A).
Regarding claims 40 and 42, although Tengler et al. does not specifically disclose pH of about 2.5-4 as claimed, 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 optimize pH of the composition of Tengler et al. as discussed above by varying the concentration of acidulants therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Tengler et al. teaches that acidulants may be included in amounts generally known to adjust pH (i.e., pH/acidulant concentration is a known result-effective variable).
Claims 21-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tengler et al. as applied to claims 21-36 and 38-43 above, and further in view of Mehta et al. (US 2007/0215511 A1; published 20 September 2007; of record).
Tengler et al. is relied upon as discussed above.
Tengler et al. does not specifically disclose a coating comprising about 70-90 wt% polyvinylacetate, a stabilizer, and about 2-20 wt% plasticizer as in claim 37.
Mehta et al. discloses pharmaceutical preparations comprising drug(s) bound to an ion-exchange resin to provide a drug-ion exchange resin complex having a water-insoluble water-permeable non-ionic coating that is highly flexible, substantially tack-free, maintains its film integrity, and provides controllable modified release of the active pharmaceutical(s) in the gastrointestinal tract for a duration of up to about 24 hours (paragraph [0010]). The coating is cured (paragraph [0068]). The barrier coating can comprise about 70-90 wt% polyvinylacetate (paragraph [0069]), a stabilizer and preferably about 5-10 wt% plasticizer (paragraphs [0065]-[0067], [0070]; claims 12-19).
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 use the barrier coating of Mehta et al. as discussed above as the coating in the composition of Tengler et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to combine the teachings of Tengler et al. and Mehta et al. as discussed above in order to make the coating highly flexible and substantially tack-free, while maintaining its film integrity, and providing controllable modified release of the active pharmaceutical(s) in the gastrointestinal tract for a duration of up to about 24 hours, as suggested by Mehta et al.
Response to Arguments
Applicant's arguments regarding obviousness filed 09 March 2026 have been fully considered but they are not persuasive.
Applicant argues that the Tengler et al. examples do not teach or suggest combining delayed release and immediate release components with any uncomplexed amphetamine APIs, and include elements excluded from the instant claims, and do not include elements included in the instant claims (remarks pages 9-11). In response, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments, and disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments, per MPEP 2123. Tengler et al. teaches or suggests all claimed elements as discussed in the rejections.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any 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 MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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