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 .
Applicants' arguments, filed 12/23/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 32 and 42 stand rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sun et al (Chinese J of Pharma, 2018, 978-980).
Applicants assert the prior art does not teach application of the HPMCAS coating in a mixture with only water.
Examiner disagrees. While it is true the prior art includes ethanol, the instant rejected claims are directed to a product, not a process. Thus, product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. See MPEP 2113. Here, the end result of both with and without additional solvents is a coating of HPMCAS on the capsule. Absent evidence which demonstrates a distinction in the resulting product, the claim is still anticipated.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 32-41 and 48-51 stand rejected under 35 U.S.C. 103 as being unpatentable over He et al (US 2017/0035699) in view of Deshpande et al (US2004/0028737).
Applicants reassert the water only argument now with regards to He et al, which issue discussed above.
Additionally, Applicants assert there is no motivation to coat the entire capsule based on the teaching of Deshpande et al.
Examiner notes that Applicants appear to limit the teaching of Deshpande et al to only coating the active agents, but the reference is relied upon for teaching enteric coatings generally. As such, while the focus is on coating pellets, there is nothing in the reference which suggests an enteric coating cannot be applied to the shell or entire capsule. As such, if the composition is used as a band to provide enteric delivery, coating entire would simply be an extension, albeit nonpreferred, of providing enteric delivery. But nonpreferred are still considered teachings. As such, the difference between using the film as a band and coating the entire capsule would only be a matter of coverage, with the end result being an enteric coating of HPMCAS which releases the capsule after passing the stomach.
Claims 32-41 and 48-51 stand rejected under 35 U.S.C. 103 as being unpatentable over Boldis et al (US2010/0212261) in view of Deshpande et al (US2004/0028737).
Applicants reassert the water only argument now with regards to Boldis et al, which issue discussed above.
Additionally, Applicants assert there is no motivation to coat the entire capsule based on the teaching of Deshpande et al.
Examiner notes that Applicants appear to limit the teaching of Deshpande et al to only coating the active agents, but the reference is relied upon for teaching enteric coatings generally. As such, while the focus is on coating pellets, there is nothing in the reference which suggests an enteric coating cannot be applied to the shell or entire capsule. As such, if the composition is used as a band to provide enteric delivery, coating entire would simply be an extension, albeit nonpreferred, of providing enteric delivery. But nonpreferred are still considered teachings. As such, the difference between using the film as a band and coating the entire capsule would only be a matter of coverage, with the end result being an enteric coating of HPMCAS which releases the capsule after passing the stomach.
Double Patenting
Claims 32-41 and 48-51 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,980,918 in view of Deshpande et al (US2004/0028737).
Applicants reiterate the arguments with regards to lack of water as a solvent in the second dipping, which is rebutted above. Therefore, this rejection is maintained for reasons recited above.
Claims 32-41 and 48-51 stand rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,555,908 in view of Deshpande et al (US2004/0028737).
Applicants reiterate the arguments with regards to lack of water as a solvent in the second dipping, which is rebutted above. Therefore, this rejection is maintained for reasons recited above.
Allowable Subject Matter
Claims 42-47 are allowed. Unlike the composition claims rejected above, claims 42-47 are method claims which require the active step of dip molding into the second mixture with no solvents other than water. As such, the product by process argument does not apply and there is not motivation to remove the ethanol from the methods discussed above.
Conclusion
THIS ACTION IS MADE FINAL. 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 BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon 2-6pm and Tues-Fri (9am-6pm + mid-day flex).
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, Sahana S. Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612
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