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 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 1-12 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.
Claim 1 recites the limitation “the gas generating agent” in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Is this the same as the “gas producing agent” recited in line 4?
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ji et al. CN102429886A.
This rejection has been withdrawn in view of the Amendment filed 12/03/2025.
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 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Reyes et al. US 20050058707 A1, in view of Ji et al. CN 102429886 A.
This rejection has been withdrawn in view of the Amendment filed 12/03/2025.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. CN 101269049 B, in view of Ji et al. CN 102429886 A.
Gao teaches an osmotic pump controlled release tablet comprising a tablet core and a coating. The core comprising ligustrazine phosphate, penetration enhancer, a binder, a lubricant, solubility regulator with proper amount of absolute ethyl alcohol solution containing 20% binder, the weight ratio of the ligustrazine phosphate, penetrating agent, binding agent and lubricant is 75: 240: 30 : 1,8, said coating is composed of cellulose acetate, polyethylene glycol 400, diethyl phthalate and solvent; the acetic acid cellulose, polyethylene glycol 400, diethyl phthaltate with weight volume ratio of the solvent is 30 mg: 6 to 12 ml: 3 to 9 ml: 1000 ml. See abstract and paragraph 0017. Coating weight gain of about 2% is found in paragraph 0018. Tablet core further comprises solubility regulator such as sodium bicarbonate is found in paragraph 0024.
Gao does not expressly teach the claimed penetration enhancing agent.
Ji teaches a tablet comprising a tablet core and a controlled release coating layer. Tablet core comprising indapamide as the main active agent, filling agent, penetrating agent, adhesive, release agent and lubricant, release coating layer film-forming material comprises a release film, plasticizer and/or a pore-forming agent, wherein the filling agent comprises agar, the tablet core contains 0.5%-2% main active agent, filling agent 1-20%, penetrating agent 50-90%, bond 1-15%, release regulator 1-20% and lubricant 0.5-3%. See Abstract. Filler, binder, solubilizer, glidant, lubricant, disintegrant, and penetration enhancing agent are found in paragraphs 0011 and 0015-0017. Controlled release film coating comprising semipermeable film material is found in paragraphs 0012-0013. Coating weight grain of less than 5% is found in paragraph 0019. Method for preparing the film coating tablet is found in paragraphs 0020-0027.
Thus, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to, by routine experimentation select a penetration enhancing agent in view of the teaching in Ji with the expectation to obtain film coated tablet having a release rate suitable for the delivery of any active drug. This is because Ji teaches the use of the claimed penetration enhancing agent in a controlled release tablet formulation is known and useful in pharmaceutical art, and this is because Gao teaches the desirability to include any known penetration enhancing agent, and this is because Gao teaches the inclusion of sodium chloride in a tablet core is desired.
Response to Arguments
Applicant’s arguments filed 12/03/2025 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN T TRAN whose telephone number is (571)272-0606. The examiner can normally be reached Monday-Friday, 8:30 am-5:30 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, ROBERT A. WAX can be reached at 571-272-0623. 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.
/SUSAN T TRAN/Primary Examiner, Art Unit 1615