DETAILED ACTION
Status of Application
Preliminary amendments to the claims, filed 09/16/2024, are acknowledged. Claims 1-13, 16, 18-21 are pending in this action. Claims 14, 15, 17 have been cancelled. Claims 3-11, 16, 18 have been amended. New claims 19-21 have been added. No new matter was added. Claims 1-13, 16, 18-21 are currently under consideration.
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:
The data provided in the specification are unclear, given that the data are shown without units of measurements (e.g., Pages 8, 17, 36). Appropriate correction is required.
The use of the trademarks/trade names has been noted in this application (e.g., Pages 8, 9, 11, 18, 31, 35-37, 39-41, 43). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
Information Disclosure Statement
The information disclosure statement, filed 09/16/2024, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
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 6-7, 9-10, 20 are objected to because of the following informalities:
Claim 6 comprises acronyms “USP/NF”. The acronym should be given once in parenthesis after the first use of the full term, and then the acronym is used alone thereafter if needed. Similar is applied to claims 7, 10, 20.
Claim 9 recites the limitation “exhibiting a content of the BK B2 receptor antagonist in the range from” that should be corrected to “wherein BK B2 receptor antagonist is present in an amount of from” for clarity.
Claim 10 comprises the typographic error “about 0.5 to 6.5” that needs to be corrected to “from about 0.5 to 6.5” or clarified. Similar is applied to other numerical limitations recited in claim 10.
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 3-10, 13, 18-21 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 3 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. Similar is applied to claims 4-5, 8-10, 19. Clarification is required.
Claim 6 comprises parenthetical expression “(USP/NF)” that does not clarify the scope of the claim. To this point, it is noted that parenthetical expressions are not permissible, which do not contribute to clearness or exactness in stating applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). In the present case, said claim contains parentheses, which raises the question as to which feature of the claimed constituent is required by the claim. Similar is applied to claim 7. Clarification is required.
Claim 9 recites the limitation “in the range from about 5 mg to about 100 mg per g” that is not reasonably clear, because the amount/concentration of the constituent is not clearly delineated. Similar is applied to other amount/content limitations recited in claims 9, 21. Clarification is required.
Claim 9 is unclear and indefinite, because said claim recites a broad range/limitation (i.e., 5 mg to about 100 mg) together with a narrow range/limitation (e.g., 5 mg to about 60 mg) that falls within the broad range/limitation in the same claim. Further, it is noted that where broad language is followed by "such as" and then narrow language, the claim is indefinite, because it is unclear if the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. See Exparte Steigewald, 131 USPQ 74 (Bd. App. 1961); Exparte Hall, 83 USPQ 38 (Bd. App. 1948); Exparte Hasche, 86 USPQ 481 (Bd. App. 1949). Therefore, the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. MPEP § 2173.05. Similar is applied to claims 10, 18, 21. Clarification is required.
Claim 10 recites the limitations “SO parts (in weight)”, “such as 40 hydrogenated castor oil” that is unclear. Clarification is required.
Claim 10 recites the term “essentially consisting” that is not reasonably clear. 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 13 recites the limitation “a capsule wall which comprises gelatine, water, and at least one plasticizer selected from propylene glycol, glycerol, sorbitol, sorbitan, sorbitol-based plasticizer mixtures, or any combinations thereof” that is not reasonably clear. To this point, it is noted that the members of the Markush group must belong to a recognized physical or chemical class or to an art-recognized class. MPEP §803.02. In the present case, some members of said group are defined by their chemical properties, whereas other members are defined by their functionality (i.e., sorbitol-based plasticizer mixtures). This limitation was interpreted as best understood as “wherein a capsule wall comprises gelatine, water and a plasticizer selected from the group consisting of propylene glycol, glycerol, sorbitol, sorbitan, and any combinations thereof”. Clarification is required.
Claim 20 is rejected as being dependent on rejected claims 8 and 19 and failing to cure the defect.
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 1-2, 11-12, 16 are allowed.
Claims 3-10, 18-21 are rejected, but would be allowable if rewritten or amended to overcome the 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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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615