DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification and claims as well as applicant arguments/remarks, filed 04/27/2026, is acknowledged. Amendments to the specification have been entered.
Claims 1-13, 16, 18-22 are pending in this action. Claims 14, 15, 17 have been cancelled previously. Claims 3-6, 8-10, 13, 18-19, 21 have been amended. New claim 22 has been added. No new matter was added. Claims 1-13, 16, 18-21 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a 371 of PCT/EP2022/072049, filed August 5, 2022, which claims benefit of foreign priority to EP21189990.1, filed August 5, 2022.
Specification
The lengthy specification (45 pages, exclusive of claims) has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. MPEP 608.01.
The specification is objected to because of the following informalities: As stated previously, the data provided in the specification are unclear, given that the data are shown without units of measurements, e.g., “percent” (Page 8), “%” (Pages 17, 36). In the present case, it is unclear what “percent” is disclosed – wt%, mol%, etc. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement, filed 04/27/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
Applicant has submitted the information disclosure statement comprising oversized references (e.g., comprising 166, 266, 111, 193, 264, 127, 118, 165 pages) without specifically pointing out where relevant material can be found in each of the references. As a result, the examiner has considered said references and/or information disclosure statement to the extent permitted by the allotted time for such consideration and consistent with the MPEP.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
The information disclosure statement does not include Certificate Statement and Privacy Act Statement (MPEP 609), and/or does not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
Claim Objections
Claims 10, 22 are objected to because of the following informalities:
Claim 10 comprises the typographic error “99.5 to 99.5 wt%” that needs to be corrected to “from 99.5 to 99.5 wt%”. Similar is applied to other constituents recited in claim 10.
Claim 10 comprises the typographic error “50 parts (in weight) propylene glycol monocaprylate type II” that needs to be corrected to “50 parts by weight of propylene glycol monocaprylate type II” or clarified. Similar is applied to other constituents recited in claim 10.
The acronyms recited in new claim 22 should be removed, because said acronyms are not used in subsequent claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 6-7, 9-10, 20-21 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.
Claim 6 recites the limitation “propylene glycol monocaprylate type II of the United States Pharmacopeia and The National Formulary (USP/NF)” that is unclear and indefinite. In the present case, it is noted that said claim does not clearly define the structure of the constituent/compound to be used in the claimed product, but make a reference to the products disclosed by USP/NF. To this point, it is noted that “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Given that the structure of said constituent, e.g., “propylene glycol monocaprylate type II”, is not clearly delineated, one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Similar is applied to claims 7, 10, 20. Clarification is required. MPEP 2111.04 and 2173.05
Claim 9 recites the limitation “from 5 mg to 100 mg per g” that is not reasonably clear, because the amount/concentration of the constituent is not clearly delineated. This limitation was interpreted as best understood as “from 5 mg to 100 mg per g of the liquid pharmaceutical composition” Similar is applied to other amount/content limitations recited in claims 9 as well as to claim 21. Clarification is required.
As stated previously, claim 10 recites the term "about” that is a relative term, which renders the claim indefinite. This term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Clarification is required.
Claim 10 further recites the limitations “parts (in weight)” that is not reasonably clear. This limitation was interpreted as best understood as “parts by weight”. Clarification is required.
Claim 10 recites the limitation “liquid vehicle consisting of (i), (ii), (iii)” and further recites the limitation “and optionally (iv)” that is unclear. In the present case, the scope of the claim (i.e., consisting of) is not clearly delineated. Similar is applied to the recited constituents (a-I)-(c-I). Clarification is required.
Response to Arguments
Applicant's arguments, filed 04/27/2026, have been fully considered. Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action. Applicant is advised to clarify claims 6-7, 9-10, 20-22 to place the application in condition for allowance.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The prior art does not teach liquid pharmaceutical compositions suitable for oral administering and comprising a bradykinin B2 receptor antagonist having a chemical structure as instantly claimed, wherein said compositions comprise the bradykinin B2 receptor antagonist in a dissolved form in a liquid vehicle comprising propylene glycol monocaprylate, polyoxyl castor oil, and propylene glycol. Applicant teaches that said compositions substantially enhance oral delivery of the bradykinin B2 receptor antagonist, lead to unexpectedly rapid absorption of the compound into the bloodstream of a subject, provide excellent stability and allow for sufficient drug load.
Conclusion
Claims 1-5, 8, 11-13, 16, 18-19 are allowed.
Claims 6-7, 9-10, 20-22 are objected and/or rejected, but would be allowable if rewritten or amended to overcome the objections and/or rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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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.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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