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 .
Acknowledgment of Papers Received: Amendment dated 1/20/26.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined disclosures of Sowden et al (CA 3 031 474 A1 hereafter Sowden) in view of Howard et al (US 2021/0378968 hereafter Howard) and Stevens et al (US 5,980,944 hereafter Steven).
Sowden teaches a variety of solid dosage forms comprising at least two cavities on opposing sides on the surface [Fig. 6B, 6H]. The cavities can contain simethicone either in the core or the immediate release portion [Figure 18, 19]. The coating portion, part 301 or 303 can comprise the polymer, immobilizing the simethicone [Figure 19]. These components can be present in the core, coating and immediate release portions [0055-0057]. The solid dosage forms comprising discontinuous coatings applied to tablet and capsule core because the tablets or capsules have multiple cavities [0029, Fig. 7]. The dosage forms comprise substrates or cores of a variety of shapes including shapes with opposing surfaces, where the opposing faces comprise cavities [pg 16, Figure 6]. The dosage can comprise simethicone [0062] along with active agents like loperamide [0063]. The substrate can be elongated [0053 Figure 7]. The substrate or core comprises calcium carbonate or magnesium hydroxide and is coated [0061]. The cavities can be filled with an active composition [Figure 6A, 6B] and coated [0085].
The reference discloses a dosage form comprising a coated substrate with at least one cavity on the surface comprising simethicone immobilized. The reference is however silent to diffusion of the immobilized agent. Optimizing the diffusion of an applied active agent is known in the art as seen in the Howard patent.
Howard discloses a solid dosage form comprising a tablet core with cavity along the surface [abstract, Fig. 1]. There can be four cavities, with two on each side or multiple shaped cavities [Figures]. The tablet can be elongated and comprise loperamide [Figures, 0123, Example 9]. The active agent is deposited onto the tablet and immobilized such that the deposited agent diffuses from the dosage from at less than 30 mm2 [0151]. The tablet further comprises calcium carbonate and aluminum hydroxide [0123]. The tablet further comprises simethicone [0239-0244]. The tablet is coated with film forming polymers where the coating has a weight based on the core about 1-5 percent [0139-0141]. It would have been obvious to include the diffusion rate of Howard into the tablet of Sowden as they solve the same problem.
As discussed above, Sowden discloses a solid dosage form comprising multiple cavities on the surface, where they can oppose each other [Figure 6A, 6B, 18,19]. The dosage forms comprise simethicone, and an immobilizing polymer coating. The dosage form can comprise four cavities depending on the punch and orientation of manufacturing device [Fig. 6H]. The refence discloses that the solid dosage form is formed by flowing materials into a mold for shaping [0044]. The reference discloses that the flowable materials include polymers and carbohydrates that are meltable and flow below 150°C is silent however to the specific materials of claim 18. These specific compounds are found in the prior art as seen in Stevens.
Stevens teaches a dosage form comprising a substrate with at least one cavity wherein the cavity comprises simethicone and one material that immobilizes the simethicone (abstract, Figures 3, 4, col. 3, lin. 23-55). The substrate is a table core (Figure 3,4). The core is elongated and the tablet comprises loperamide (Figure 3,4, col. 5, lin. 3-22). The dosage form further comprises magnesium stearate (col. 5, lin. 53-57). The tablet core is coated (Figure 3, 4, parts 22, 30). The coating is a polymer including trimethylammonium ethyl methacrylate chloride which has a melting point less than 120 °C (- 25 °C) and can be gelled ionically (col. 4, lin. 5-35). The dosage forms are formed by forming a core and filling it with simethicone and a blend of a polymer that either immobilizes the compound or coating the simethicone core with a polymer that immobilizes the compound (Examples). The simethicone is flowable when applying in the method and is dried in the process (Examples). It would have been obvious to apply these polymers to the formulation and method of Sowden as they solve the same problem.
With these aspects in mind it would have been obvious to combine the prior art with an expected result of a stable solid dosage form. It would have been obvious to apply the diffusion rate of Howard into the similar formulation of Sowden as they solve the same problem and have the same components. It would have been obvious to apply the polymers of Steven in to the similar dosage form of Sowden as they solve the same problem. One of ordinary skill in the art would have been motivated to combine the prior art with an expected result of a stable oral dosage useful in controlled drug delivery.
Response to Arguments
Applicant’s arguments, see Amendments, filed 1/20/26, with respect to the rejection(s) of claim(s) 1-23 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the above recited rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICAH PAUL YOUNG whose telephone number is (571)272-0608. The examiner can normally be reached Monday through Friday, 9:00 am to 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, Michael Hartley can be reached at 5712720616. 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.
/MICAH PAUL YOUNG/Primary Examiner, Art Unit 1618
Prosecution Insights