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 .
Status of Application
The Preliminary Amendment filed on 05/27/25 is acknowledged.
Claims 3, 12, 17, 21, 23, 25-26, 29, 32, and 35-44 were cancelled.
Claims 1-2, 4-11, 13-16, 18-20, 22, 24, 27-28, 30-31, and 33-34 were amended.
Claims 1-2, 4-11, 13-16, 18-20, 22, 24, 27-28, 30-31, and 33-34 are pending and included in the prosecution.
Priority
This Application is a 371 of PCT/EP2022/079666 filed on 10/24/22. This Application also claims foreign priority to PCT/EP2021/079584 filed on 10/25/21. Receipt is acknowledged of certified copies of papers submitted under 35 U.S.C. 119 (a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/24/24 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the examiner is considering the information disclosure statement. Please see the attached copy of PTO-1449.
Specification
The disclosure is objected to because of the following informalities: On Page 1, line 36, the term “Transgluaminase” should be corrected to recite “Transglutaminase.” Appropriate correction is required.
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 11, 13, 24, and 27 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 pre-AIA the applicant regards as the invention.
Claims 11, 13, 24, and 27 contain the trademarks/trade names Eudragit® and claim 27 also contains the trademark Macrogol ®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademarks/trade names Eudragit® and Macrogol® are used to identify/describe methacrylic acid-methyl methacrylate copolymers and polyethylene glycol, respectively and, accordingly, the identification/description is indefinite.
It is recommended that the trademark/tradenames be removed from the claims in favor of the generic descriptions. It is also recommended that the generic terminology be recited positively without being enclosed in parentheses. Please see MPEP 2173.05(d).
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Buchold et al. (US 2015/0203535 A1 – “Buchold”) is cited as art of interest for teaching pyridinone derivatives as inhibitors for tissue transglutaminase (Abstract), including (S,E)-methyl 7-(1-(2-(2-ethyl butylamino)-2-oxoethyl)-2-oxo-1,2-dihydropyridin-3-ylamino)-6-(1-methyl-1H-imidazole-5-carboxamido)-7-oxohept-2-enoate (compound A63) ([0097]). Buchold also teaches a method for treating diseases associated with tissue transglutaminase ([0001]) including the treatment or prophylaxis of coeliac disease ([0004], claim 24) which is characterized by a chronic inflammation of the mucosa of the small intestine ([0004]). Buchold teaches coated tablets ([0149] and [0150]) but does not mention a plurality of particles in the form of coated granules, coated pellets, coated beads, coated minicapsules, or coated minitablets comprising a core material and an enteric polymer as recited in instant claim 1.
Conclusion
Claims 11, 13, 24, and 27 are rejected.
Claims 1-2, 4-10, 14-16, 18-20, 22, 28, 30-31, and 33-34 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARADHANA SASAN whose telephone number is (571)272-9022. The examiner can normally be reached Monday to Friday from 6:30 am to 3:00 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 on 571-272-6023. 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.
/ARADHANA SASAN/Primary Examiner, Art Unit 1615
Prosecution Insights