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 .
Priority
The instant application was filed 17 August 2023 and is the continuation of 18/451,462 filed 17 August 2023. The Application claims priority to provisional application 62/771,453 filed 26 November 2018 and is a CIP of 16/693,051 filed 22 November 2019. Therefore, the effective filing date of the instant application is 26 November 2018.
Election/Restrictions
Applicant’s election without traverse of Cremophor RH40, Vitamin E, and Transcutol in the reply filed on 15 December 2025 is acknowledged.
Claim Objections
Claim 1 is objected to because of the following informalities: “greater than the solubility of the pharmaceutically active ingredient alone the aqueous solution.” The Applicant is advised to correct the confusing language. Appropriate correction is required.
Claims 2 and 8 are objected to because of the following informalities: “Maisine® CC, and Vitamin E” with an unnecessary comma between Maisine® CC and Vitamin E. The Applicant is advised to strike out the extra comma. 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 1-9, 13, and 18 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.
Claims 1-9, 13, 18 contain the trademark/trade name Tween 80, Tween 40, Tween 20, Lauroglycol 90, Labrasol, Cremophor RH40, Cremophor EL, Labrafil M2125, Labrafil 1944, Span 80, Capryol, Peceol, Miglyol 812, Maisine CC, Labrafac WL 1349, and Transcutol. 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 various surfactants, oils, or cosolvents and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ambuhl et al. (US 2003/0216303 A1).
Ambuhl teaches a microemulsion composition (abs; entire teaching) that spontaneously forms (para. 45), which is interpreted as a self-microemulsifying drug delivery system to deliver a drug, such as Cyclosporine A (para. 56), which is interpreted as CRV431 in claims 12 and 16. The composition fits into a three-way phase diagram (para. 158), which is interpreted as a pseudo-ternary phase system. Cyclosporin is interpreted as a poorly soluble drug in water. Therefore, it is interpreted and expected for cyclosporin to be dispersed at a concentration greater than the poor solubility of cyclosporin in water (para. 54), addressing the limitation in claim 1. The composition may comprise 5-50% of Transcutol as a second component and carrier medium (paras. 50, 101), 32.4% of Maisine (paras. 104, 239), 38.6% of Cremophor RH40 as a surfactant (paras. 129, 239), 9.5% of propylene glycol (paras. 101, 239), 0.05-1% of vitamin E (para. 193), 1-15% of cyclosporine (para. 53), and 0-60% of ethanol (para. 101), addressing claims 1, 2, 7-9. Ambuhl describes the compositions comprising the drug to be stable and intact after days or weeks at room temperature (para. 209), addressing claims 10, 11, and 15. These physical properties, such as the system’s stability, are interpreted as properties that would naturally and necessarily occur given the combination of components present in the system. The diameter of the particles may be less than 100 nm but greater than 10 nm (para. 46), addressing claim 14.
Ambuhl does not teach a specific combination of the components listed in at least claim 1 or the specific ratios or concentrations in claims 3-6, 13, 18-20.
In regards to selecting the combination of cyclosporin A, Transcutol, Maisine, Cremophor RH40, propylene glycol, vitamin E, and ethanol in at least claim 1, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Ambuhl teaches compositions and methods for making a self-microemulsifying drug delivery system, whereas the claimed invention is directed towards a pseudo-ternary phase system comprising an active ingredient, a surfactant, an oil, and a cosolvent. Since Ambuhl teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to the ratios and concentrations in claims 3-6, 13, and 18-20, Ambuhl teaches 5-50% of Transcutol as a second component and carrier medium (paras. 50, 101), 32.4% of Maisine (paras. 104, 239), 38.6% of Cremophor RH40 as a surfactant (paras. 129, 239), 9.5% of propylene glycol (paras. 101, 239), 0.05-1% of vitamin E (para. 193), 1-15% of cyclosporine (para. 53), and 0-60% of ethanol (para. 101). That being said and in lieu of objective evidence of unexpected results, the concentration and ratios can be viewed as a variable that achieves the recognized result of successfully making the pseudo-ternary system composition, which a skilled artisan would have been easily motivated to modify and adjust. The optimum or workable range of amounts can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of the components as nonobvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613