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 .
Specification
The use of terms such as Cardomec, Capryl 90, and Stromectol, which are trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The specification 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.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 part (iii) recites “selected from one or more of … and/or…”. Examiner suggests amending to “a second surfactant selected from one or more of a polysorbate surfactant or a fatty acid ester of sorbitan” for clarity.
Claims 5-19 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n). Accordingly, claims 5-19 have not been further treated on the merits.
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 1-4 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 part (ii) recites (paraphrased to omit surfactant names), “a first surfactant comprising one or more of (a), (b), and (c)”. The use of the phrase “comprising” followed by “one or more of … and” renders the scope of the claim indefinite as it is unclear whether all the listed elements are part of the claimed invention. "Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim. In contrast “one or more of” suggests that only one of (a), (b), or (c) is required to be present. Additionally, the use of “and” seems to suggest all elements need to be present. For purposes of compact prosecution, this limitation will be interpreted to read, “a first surfactant comprising one or more of (a), (b), or (c)”.
Regarding claims 2-4, these claims depend from claim 1 and do not cure the deficiencies of claim 1. Therefore, claims 2-4 inherit the deficiencies of parent claim 1.
Examiner Note - 35 USC § 112
Although claims 7-8, 16 and 18 are not being considered on the merits, Examiner would like to extend a courtesy note that these claims contain trademarks or trade names (Masester M8120, Capryol 90, Labrasol ALF, Tween 80, and Span 20) which would normally necessitate a 112(b) rejection. 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(b) or 35 U.S.C. 112 (pre-AIA ), 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 trademark/trade name is used to identify/describe surfactants, and, accordingly, the identification/description is indefinite. Examiner suggests that Applicant address this in the reply to this Office Action.
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) 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (WO2021/138564, published 7/8/2021, cited on the 9/20/2024 IDS ), as evidenced by Menez et al (2012).
Regarding claims 1 and 4, Patel teaches a dissolvable oral film comprising an active pharmaceutical agent and surfactant [pg. 1 line 25-26]. Patel teaches that the pharmaceutical agent may be ivermectin [pg. 71 line 9] present in the amount of 0.5% to 10 % [pg. 71 line 16] (reads on instant claims 1, 4). Patel specifies that the ivermectin of its invention comprises 22, 23-dihydroavermectin B1a and 22,23-dihydroavermectin B1b [pg. 55 lines 18-19], which respectively correspond with the instantly claimed Formula VI and Formula VII. Patel further teaches that the composition may comprise of one or more surfactants including glyceryl monocaprylate (a mono fatty acid ester of glycerol) in range of 0.5 to 40% and sorbitan monooleate (a fatty acid ester of sorbitan) in the range of 0.5 to 40% [pg. 63, Embodiment A]. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claims 2 and 3, Patel does not explicitly teach the instantly claimed amounts of Formula VI (i.e. 22, 23-dihydroavermectin B1a) and Formula VII (i.e. 22,23-dihydroavermectin B1b) comprising the ivermectin of the composition. However, evidentiary source Menez teaches that Ivermectin is a mixture of the B1a and B1b forms of the drug, wherein the majority (around 90%) of the drug is in the B1a form and the remainder is in B1b form. Thus, the limitations of claims 2 and 3 are inherently met.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA LYNN CHI whose telephone number is (571)272-0026. The examiner can normally be reached Monday - Friday 9 am-5pm ET.
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/AMANDA LYNN CHI/Examiner, Art Unit 1613
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
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