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 .
Applicant’s response and claim amendment filed on November 13, 2025 have been fully considered.
The previous claim rejections made under 35 U.S.C. 112 (b) as indicated in the Office action dated August 13, 2025 are withdrawn in view of the amendments made to the rejected claims.
The previous claim rejection made under 35 U.S.C. 102 over Raghunathan (US 4221778 A) is withdrawn in view of the amendment made to claim 1 which requires that the one or more functional barrier coatings comprise hypromellose and/or talc.
The previous claim rejection made under 35 U.S.C. 103 over Meadows et al. (U 20030099711 A1) is withdrawn for the same reason. A new rejection has been made to address the amended claim 1.
The previous claim rejection made under 35 U.S.C. 103 over Meadows and further in view of Jain et al. (US 20110268808 A1) is withdrawn and modified to address the amended claim; the original grounds of rejection have been maintained.
The previous claim rejection made under 35 U.S.C. 103 over Meadows and further in view of Mehta et al. (US 20130136797 A1) is withdrawn and modified to address the amended claim; the original grounds of rejection with respect to claims 22-37 have been maintained.
The previous claim rejection made under 35 U.S.C. 103 over Meadows and further in view of Templeton et al. (CA2355829 A1) is withdrawn and modified to address the amended claim; the original grounds of rejection 37 have been maintained.
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.
Claims 1 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Meadows et al. (U 20030099711 A1, published on May 29, 2003) (“Meadows” hereunder) in view of Allphine et al. (US 20180318222 A1, published on November 8, 2018) (“Allphine” hereunder).
The amended claim 1 is directed to an extended-release suspension composition comprising:
a) polymeric coated active ingredient-ion exchange resin complex comprising:
(i) active ingredient particulate matrix comprising active ingredient-ion exchange resin complex, the active ingredient being a pharmaceutically acceptable active ingredient,
(ii) solvation coating on the active ingredient-ion exchange resin complex to generate a pre-coated active ingredient-ion exchange resin complex,
(iii) one or more functional barrier coatings on the pre-coated active ingredient—ion exchange resin complex, wherein said one or more functional barrier coatings provide modified release profile to said pharmaceutically acceptable active ingredient, and
b) pharmaceutically acceptable excipients,
wherein said extended-release suspension composition is devoid of uncoated active ingredient-ion exchange resin complex portion and polyvinyl acetate, and
wherein said one or more functional barrier coatings comprise hypromellose and/or talc.
Meadows teaches an oral pharmaceutical preparation sustained release comprising a pharmaceutically active drug bound to small particles of an ion-exchange resin, which is coated with an aqueous based diffusion barrier comprising a water-permeable, film forming polymer such as ethyl cellulose, which provide a controlled sustained release of drug under conditions encountered in the gastrointestinal tract. See abstract; the present claim (i) and (iii). The reference further teaches, “at least some of the barrier coated drug-resin particles may be coated with an enteric coating to provide a tailored release profile”. See Id; reference claim 14. The enteric coating also meets the one or more functional barrier coating limitation of (iii).
As for the present claim 1 (ii), Meadows further teaches that the drug-resin particles are treated with a solvating or impregnation agent by adding in the complexation step or preferably coated with it after complexing. See [0037]. The effective solvating agents include polyethylene glycol, povidone (polyvinylpyrrolidone), hypromellose (hydropropylmethylcellulose), propylene glycol, etc. The reference teaches, “[t]his treatment helps particles retain their geometry, and enables the effective application of diffusion barrier coatings to such particles”. See Id.
Example 1 discloses a formulation comprising (i) phenylpropanolamine complexed with polystyrene (ion resin), (ii) treated with a solvating agent, PEG, and (iii) coated with an aqueous dispersion of ethylcellulose. The barrier coated drug-resin complex was used in making six different formulations, each with different amount of Opadry and/or different amounts of a second barrier coating material (Surelease, ethylcellulose). There is no indication that any of the drug-ion exchange resin complex is uncoated.
The reference teaches formulating the composition in the form of suspensions reconstituted from non-effervescent granules, containing excipients such as suitable solvents, preservatives, emulsifying agents, suspending agents, diluents, sweeteners, coloring agents and flavoring agents. See [0055-0056]. Following such teaching to make a sustained release suspension comprising phenylpropanolamine would have been prima facie obvious. See present claim 1.
Meadows teach that film forming polymers can be mixed pigments or with other substances to alter the characteristics of the coating. The reference teaches that, while the major components of the coating should insoluble in and permeable to water, pharmaceutically acceptable polymers such as hydropropylmethylcellulose (Hypromellose), ethylcellulose, etc. can be used. See [0040].
As for talc, Allphin teaches that talc is an anti-tack agent and a filler which are added to functional coating composition to make the film crushable during the transition of the composition in the GI. The reference teaches that the duration or extent of the drug delivered by varying the filler levels in the film. See [0055].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Meadows and incorporate talc in the film coating composition of Meadows as Allphin suggests that duration or extent of the drug release can be further adjusted by such addition and adjusting the filler level in the film. Since Meadows teaches incorporating substances to alter the properties of the coating, the skilled artisan would have had a reasonable expectation of successfully producing a sustained release pharmaceutical composition with a targeted release property.
Regarding claim 21, Meadows teaches that other suitable drugs for the formulation include methylphenidate hydrochloride, amphetamine, dextroamphetamine, etc. See [0030]; reference claim 13.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Meadows and Allphin as applied to claim 1 and 21 above, and further in view of Jain et al. (US 20110268808 A1, published on November 3, 2011) (“Jain” hereunder).
Jain teaches a dual release aqueous liquid suspension containing extended-release drug particles. The reference further teaches that suitable excipients for the composition include thickeners, preservatives, glidants (anti-tacking agents/lubricants), chelating agents, plasticizers (solvation coating agent), complexing agents (ion exchange resin), buffering agent, suspending agents, release modifiers (barrier coating polymers/entrapment polymer), wetting agents (surfactants), as well as flavoring agents (taste masking agent), sweeteners, etc. See [0055]. The reference also teaches, “certain excipients used in the present composition can serve more than one purpose.”
Meadows and Jain are both directed to oral suspensions comprising microparticles comprising drugs having modified release profiles and disclose pharmaceutical excipients suitable to formulate the composition. Combining art-recognized functional equivalents for same purposes is prima facie obvious. See MPEP 2144.06. Thus, it follows that combining the excipients of Meadows and Jains to make a stable oral suspension would have been prima facie obvious.
Claims 22-37 are rejected under 35 U.S.C. 103 as being unpatentable over Meadows and Allphin and as applied to claims 1 and 21 above, and further in view of Mehta et al. (US 20130136797 A1, published May 30, 2013) (“Mehta” hereunder).
Regarding claim 22, Meadows teaches that suitable excipients for the suspension include suitable solvents, preservatives, emulsifying agents (surfactants), suspending agents, diluents, sweeteners and flavoring agents (taste masking). See [0055-0056]. The reference also teaches ion exchange resin, solvation coating agent, entrapment polymers and functional barrier coating polymers as discussed above. See also the present claim 27.
Although Meadows generally teaches suitable excipients for the extended-release suspension, the reference fail to teach all of the excipients of the present claims.
Regarding claims 24, 33, 35-37, Mehta teaches a liquid suspension containing a coated drug-ion exchange resin complex. The reference further teaches and suggests that such composition may be formulated with conventional pharmaceutically acceptable excipients including: lubricants (magnesium or calcium stearate, talc, also anti-tacking agent); thickeners (xanthan gum, starch, etc); surfactants such as polysorbates; stabilizing agents such as preservatives such as methyl or ethyl parabens, chelating agents such as EDTA; sweeteners such as high fructose corn syrup, sucrose, xylitol, etc.; flavoring agents such as vanilla, fruit flavors, etc; buffers; plasticizers such as dibutyl sebacate, propylene glycol, etc. See [00640077-0088]
Meadows and Mehta are both directed to oral suspensions comprising microparticles comprising drugs having modified release profiles and disclose pharmaceutical excipients suitable to formulate the composition. Combining art-recognized functional equivalents for same purposes is prima facie obvious. See MPEP 2144.06. Thus, it follows that combining the excipients of Meadows and Jains to make a stable oral suspension would have been prima facie obvious.
Regarding claim 23, Meadows teaches that the ion resin used in the invention is sulfonated polystyrene.
Regarding claim 25, Meadows teaches that the effective solvating agents include polyethylene glycol, povidone (polyvinylpyrrolidone), hypromellose (hydropropylmethylcellulose), propylene glycol, etc.
Regarding claim 26, Meadows Example 1 discloses that ethylcellulose is used in treating the pre-coated drug-ion resins.
Regarding claim 28, Meadows teaches that plasticizers for ethylcellulose include dibutyl sebacate, triethyl citrate, etc. See [0041].
Regarding claim 29, Meadows teaches that guar gum is used as a suspending agent; using guar gum as a suspending agent would also provide a taste masking effects. See [0056].
Regarding claim 31, Mehta teaches citric acid used in an example suspension comprising dextromethorphan. See [0163].
Regarding claim 32, Meadows teaches that microcrystalline cellulose is used as a suspending agent. See [0056].
Regarding claim 34, Meadows teaches methyl propyl paraben, etc are used as preservatives. See [0060]. Mehta teaches that drug release rate can be modified by treating the drug-ion exchange complex with a release retardant prior to the application of the water-permeable diffusion barrier coating. See [0052]. Such release retardants include water-insoluble polymers including PVA, cellulose acetates, ethylcellulose, acrylic based polymers, etc. See [0053]. The reference further teaches that the retardants can be added after formation of the drug-ion exchange resin complex. See [0055].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Meadows and Mehta as applied to claims 1, and 21-37 above, and further in view of Templeton et al. (CA2355829 A1, July 13, 2000) (“Templeton” hereunder).
Meadows fails to teach placebo granules.
Templeton teaches oral dosage form comprising a drug adsorbed to an ion exchange resin and a taste-masking agent, which may be reconstituted as a suspension. See abstract. The reference teaches placebo granulates comprising a flavoring agent inside and outside of the granule and combined with the drug-resin complex. See p. 9, lines 8-19.
Given the teachings of using flavoring agents in the formulations in Meadows, one of ordinary skill in the art would have been obviously motivated to look to prior art such as Templeton for teachings on providing flavor in in the suspension and combine placebo granules comprising flavoring agents with the oral suspension of Meadows. Since both references are directed suspension comprising drugs complexed with ion exchange resins, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and produce a stable suspension with improved taste.
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 GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GINA C JUSTICE/ Primary Examiner, Art Unit 1617