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. Priority Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement s (IDS) submitted on 11/15/2023 and 1/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement s are being considered by the examiner. 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 appl icant regards as his invention. Claim 14 is 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. In regard to claim 14, the word “preferably” renders the claim indefinite because it is unclear if the limitation is required or a preferred embodiment. For the purposes of this action, the latter interpretation is used. The applicant is encouraged to delete the term. 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. Claim(s) 1-4, 7-17, and 19-20 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Universitat Greifswald (WO 2020/183005; hereafter Greifswald) . In regard to claim 1, Griefswald discloses a capsule device ( 23 ) for the application to a mucous membrane, configured to accommodate a pharmaceutical preparation (2) having an elongated shape and comprising an active pharmaceutical ingredient (see page 58, line 25- page 59, line 4) , and capable of being arranged in a compact condition and in an expanded condition ( EXAMINER NOTE: the active pharmaceutical ingredient is functionally claimed; see page 58, line 25- page 59, line 4) , the capsule device comprising a hollow space (see at least Fig. 3a-3b) for accommodating the preparation in the compact condition, the capsule device having an aperture (25) , configured to allow a first end of the preparation in the compact condition to extend through the aperture such that the preparation can be transferred from its compact condition in the hollow space to its expanded condition in the surrounding area of the capsule device (see Figs. 3a-3f) , the capsule device comprising a first halve-capsule shell (23a) and a second halve-capsule shell (23b) , which are joined by overlapping the first halve- capsule shell and the second halve-capsule shell in a joined position (see Figures 2a-2e) , characterized in that the capsule device further comprising a hollow-cylindrical wall part (25a.2) , and wherein the first halve-capsule shell (23a) has a hollow-cylindrical wall including an opening (25a.1, 25c) , and said hollow-cylindrical wall part overlaps a cross section of the opening thereby forming the aperture of the capsule device in the joined position (see Fig. 2e and page 62, lines 15-17) . In regard to claim s 2 -3 , Griefswald discloses wherein the hollow-cylindrical wall of the first halve-capsule shell ( 23a ) is closed at a first end (end opposite of 25) and open at a second end ( at 25 ), and wherein the opening ( 25a.1, 25c ) is fully surrounded by the material of the hollow-cylindrical wall ( see Fig. 2d ). In regard to claim 3, 25 is described as a recess that extends around towards the first end. In regard to claim 4, Griefswald discloses wherein the cross-section of the opening ( 25a.1, 25c ) is dimensioned to receive the preparation (2) in its compact condition before joining the first halve-capsule shell (23a) and the second halve-capsule shell ( 23b ), wherein, in the joined position, the aperture ( 25 ) defined by the opening ( 25c, 25a.1 ) and the hollow cylindrical wall part has a cross-section dimensioned to prevent the preparation (2) in its compact condition from passing through the aperture ( 25 ) ( EXAMINER NOTE: the active pharmaceutical ingredient is functionally claimed ; see Figs. 3a-3f). In regard to claim 6, Griefswald discloses , wherein, in the joined position, the first halve-capsule shell ( 23a ) is inserted into the second halve-capsule shell ( 23b ). In regard to claim 7, Griefswald discloses wherein the aperture ( 25 ) is a slit-like opening, configured for allowing the preparation (2) to pass through the aperture ( 25 ), the cross-section (CS) of the aperture ( 25 ) being larger than the cross section of the strip-like preparation (2), when the latter is extending through the aperture ( 25 ) (see Figs. 3a-3f) . In regard to claim 8, Griefswald discloses wherein the capsule device ( 23 ) is configured to be suitable to be swallowed by a patient (see page 4, lines 25-30) . In regard to claim 9, Griefswald discloses which comprises a sinker device (60), which occupies a part of the hollow space and which provides an additional weight to the capsule device. In regard to claims 10-16 and 19-20 , please see the rejections above as the examiner believes all of the appropriate structure and disclosure is addressed. In regard to claim 17, Griefswald discloses a pharmaceutical dosage form according to claim 13, a drinking cup (101) , and an applicator (100) for administering the pharmaceutical dosage form to a patient, wherein the applicator is in fluid connection with the drinking cup (see Figs. 9a-9b) and comprises the pharmaceutical dosage form and wherein the preparation of the pharmaceutical dosage form is connected to the applicator by a retainer (2b) for withdrawing the preparation from the capsule device after administration to the patient. 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) 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Griefswald . The instant disclosure describes the parameters of the ratio of the cross-section of the aperture to the cross-section of the opening as being merely preferable, and does not describe these ratios as contributing any unexpected results to the system. As such, parameters such as the ratio of the cross-section of the aperture to the cross-section of the opening are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation ratio of the cross-section of the aperture to the cross-section of the opening would be dependent on the actual application of the system and, thus would be a design choice based on the actual application. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT THEODORE J STIGELL whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-8759 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 9-5:30 EST . 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, FILLIN "SPE Name?" \* MERGEFORMAT Michael Tsai can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5246 . 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. FILLIN "Examiner Stamp" \* MERGEFORMAT THEODORE J. STIGELL Primary Examiner Art Unit 3783 /THEODORE J STIGELL/ Primary Examiner, Art Unit 3783