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 .
Status of the Application
A request for continued examination under 37 CFR 1.114, including the fee setforth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 21, 2026 has been entered.
Status of the Application
This Office Action is in response to Applicant's arguments filed on January 21, 2026. Claim(s) 1-11 and 21-28 are pending and examined herein.
Response to Arguments
Applicant’s arguments with respect to the 103 rejection of claims 1-11, 21, and 28 as being unpatentable over Zhang (CN 1854120) of record (IDS 2/10/25, Reference #1) and the 103 rejection of claims 22-27 as being unpatentable over Zhang (CN 1854120) of record (IDS 2/10/25, Reference #1) as applied to claims 1-11, 21, and 28 above in view of Morand (International Journal of Pharmaceutics, 2007) have been fully considered.
Applicant presents the following arguments:
A combination is obvious only when the combination yields merely the expected results. This has been made explicit by the CAFC which has stated “when a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields ne more than one would expect from such an arrangement, the combination is obvious.” KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 417, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007) (quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282, 96 S.Ct. 1532, 47 L.Ed.2d 784 (1976)); emphasis added. See also MPEP 2141(1).
Thus, even if the Office's reading of Zhang was credited, the Office alleges no more than a "obvious to try" rationale for modifying Zhang's lauric acid to undecanoic acid, with a reasonable expectation of obtaining no more than a composition that can solubilize drugs. This utterly ignores that obviousness in such a scenario can only exist if the modification then provides only what was expected. Here, the undecanoic acid compositions provide something (antifungal activity), which is completely unexpected in view of the cited prior art.
Applicant has previously made of record that the claimed compositions comprising undecanoic acid exhibit unexpected antifungal activity. See instant specification at paragraph [0004]. Nothing in Zhang would have provided a reasonable expectation of such an outcome.
With respect to the arguments above, examiner respectfully notes that Zhang teaches a composition comprising a quaternary ammonium salt and a carboxylate radical, both of which are embraced by the instant claims. While the undecanoic acid is not specifically exemplified, it is well within the teachings of Zhang. Examiner set forth the “homologue” rationale merely to say that an example was taught with lauric acid, wherein lauric acid is two carbons longer than undecanoic acid, therefore one could envision that the homologues are expected to be preparable by the same method and to have the same properties.
Furthermore, applicant’s finding of antifungal properties associated with the composition is not persuasive. Applicant’s arguments are not commensurate in scope of the claimed invention. Applicant provides data for choline-undecanoate ionic liquids showing greatest differential killings for three fungal species ([00210]-[00214]). Thus, in the instant case, the reason or motivation to modify a reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. While there must be motivation to make the claimed invention, there is no requirement that the prior art provide the same reason as the applicant to make the claimed invention. MPEP 2144 Sources of Rationale Supporting a Rejection Under 35 U.S.C. 103. /www.uspto..qov/web/offices/pac/mpep/documents/2100 2144.htm>.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
MPEP, KSR teaches us that under the right circumstances, “obvious to try” can indeed be the basis for a proper conclusion of obviousness. The attorney’s argument fails to account for KSR, which is a Supreme Court case. MPEP 2144.05(II)(B) states: Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
The argument does not provide a reasonable basis to conclude that the examiner failed to establish a prima facie case of obviousness.
The maintained/modified rejections are made in the Non-Final Office action below as necessitated by amendment.
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.
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.
Claims 1-11, 21, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 1854120) of record (IDS 2/10/25, Reference #1).
Regarding the intended use limitations (as recited in claim 21), such limitations of the instant claims fail to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition, which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Ptiney Bowes Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473,378, 42 USPQ2d 1550, 1554 and MPEP 2112.02(II). In the instant composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Regarding claims 1, 3, 4, and 8, Zhang teaches (claim 1, abstract):
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Regarding claims 9 and 28, Zhang teaches the composition may be used as oral liquid, injection, large infusion, spray, eye drops and other different administration methods.
Regarding claims 10, 11 and 21, Zhang teaches the composition may be used to increase the water solubility of poorly water-soluble drugs in the pharmaceutical field, such as: amphotericin B, rapamycin, cyclosporine A (abstract; claim 7).
Regarding claims 2 and 5-7, Zhang teaches a ratio of choline: lauric acid as 1:2.5 (calculation based on example 5).
Zhang does not specifically exemplify the undecanoic acid as required by the limitations of the instant claims.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known of the ionic liquid comprising a quaternary ammonium salt and a carboxylate anion wherein R can be C1-C17 (shown above) as taught by Zhang. In example 5, Zhang exemplifies lauric acid, among several examples, as the acid anion. Lauric acid has an alkyl tail two carbons longer. Compounds that differ only by the presence of an extra methyl group are homologues which are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologues. Homologues are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required.
Zhang does not specifically teach a ratio of cation to anion of from 2:1 to 1:2 as required by the limitations of claims 5-7.
As discussed above, Zhang teaches a ratio of choline: lauric acid as 1:2.5. Generally, mere optimization of ranges will not support the, patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "When the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also In re Peterson, 315 F. 3d at 1330, 65 USPQ 2d at 1382 "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages." MPEP 2114.04.
Thus, based on the foregoing reasons, the instant claims are deemed unpatentable over the cited reference.
Claims 22-27 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang (CN 1854120) of record (IDS 2/10/25, Reference #1) as applied to claims 1-11, 21, and 28 above in view of Morand (International Journal of Pharmaceutics, 2007).
Zhang is discussed above.
Zhang teaches the composition may be used to increase the water solubility of poorly water-soluble drugs in the pharmaceutical field, such as amphotericin B (abstract; claim 7).
Zhang does not specifically teach treating a fungal infection in a subject in need thereof, specifically keratitis (claim 25) or Candida, Fusarium, Curvularia and Aspergillus (claim 26), wherein the fungal infection is ocular (claim 22), wherein the subject has received corneal surgery (claims 23-24).
Regarding claims 22-24, and 27, Morand teaches local fungal infections with Candida, Fusarium, Curvularia and Aspergillus can lead to serious ulceration of the cornea and must be treated rapidly (abstract).
Regarding claim 26, Morand teaches amphotericin B is considered the treatment of choice for systemic infections caused by Candida, Aspergillus, and Fusarium (page 150, column 1, first ¶).
Regarding claim 25, Morand teaches an ophthalmic preparation of amphotericin B for the treatment of fungal keratitis (page 152, column 2, 1st full ¶).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have known of the ionic liquids containing amphotericin B as taught by Zhang and envisioned its application in the treatment of fungal infections namely keratitis, Candida, Fusarium, Curvularia, and Aspergillus. The motivation, provided by Morand, teaches that amphotericin B is considered the treatment of choice for systemic infections caused by said infections. Fungal infections with Candida, Fusarium, Curvularia and Aspergillus can lead to serious ulceration of the cornea and must be treated rapidly. Thus, the skilled artisan would employ the ionic liquid formulation containing amphotericin B for ocular purposes for the treatment of the various fungal infections of the cornea, whether or not the patient has received cornea surgery. Optimal dosages for a given set of conditions can be ascertained by those skilled in the art using conventional dosage determination taken into account by the treating physician such as the age, body weight, sex, diet and condition of the patient, the time of administration.
Based on the foregoing reasons, the instant claims are deemed unpatentable over the cited art.
Conclusion
Claims 1-11 and 21-28 are not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
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/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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