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 .
Applicant’s election without traverse of Group I, claims 1-13, in the reply filed on 16 July 2026 is acknowledged.
Claims 14-20 have been withdrawn.
Claims 1-13 are presented for examination 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 1-13 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 is rendered vague and indefinite by the phrase “wherein the oil phase, the surfactant, and the solvent are sourced from a single species of a plant”. Since the oil phase contains volatile oil from the species Nigella sativa, does the “single species of a plant” mean that the plant species is Nigella sativa? If so, it would be more clear to simply state that the oil phase, surfactant and solvent are sourced from Nigella sativa.
Claim 2 is rendered vague and indefinite by the phrase “wherein the lipid-based drug delivery system is incubated with mother of vinegar”. It is unclear how this incubation is meant to limit the claims, which are directed to a composition, not its method of use. That is – does the language mean to define the claimed system as to how it is made (i.e., a product-by-process format) or does the language simply mean that the system of claim 1 further comprises mother of vinegar (such as in claim 3).
Claim 2 is rendered vague and indefinite by the phrase “wherein the aqueous ethanoic acid has a concentration of 0.01 – 50%”. It is unclear to what the % is meant to refer. Percentage of ethanoic acid within the claimed system or the solvent component comprising ethanoic acid.
Claim 3 is rendered vague and indefinite by the phrase “which ferments with Nigella sativa carbohydrates to generate ethyl alcohol;ethyl ester and fatty acid esters esterified from at least a portion of the ethyl alcohol, forming an emulsifier and a stabilizer”. It is unclear if the semi-colon is meant to be a comma or is meant to separate recited components of the claimed system, such as in claim 4.
All other claims depend directly or indirectly from rejected claims and are, therefore, also rejected under U.S.C. 112, second paragraph, for the reasons set forth above.
“[W]here there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 35 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 USC 103 should not be based on considerable speculation about the meaning of terms employed in a claims or assumptions that must be made as to the scope of the claims.” MPEP 2173.06 II.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL G FIEBIG whose telephone number is (571)270-5366. The examiner can normally be reached M-F 8-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 5712720947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUSSELL G FIEBIG/Examiner, Art Unit 1655
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