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 Claims
Claims 1-25 are pending.
Claims 2, 7, 11-13, 15-17, 19, and 21-25 are withdrawn from consideration as directed to non-elected inventions.
Claims 1, 3-6, 8-10, 14, 18 and 20 are presented for examination and rejected as set forth in greater detail below.
Claim Interpretation
Applicants Claims are directed to compositions combining defined concentrations of each of a C7-10 alkane, EDTA or a salt thereof, and buffer, which optionally includes any of a variety of additional components including an active pharmaceutical ingredient such as the atropine applicants elected in their response filed 12 February 2026. Dependent claims indicate the composition is in the form of a cream, and more particularly an oil-in-water cream. Claim 5 indicates that the C7-10 alkane is “an emollient”: this language appears to describe a function the component identified as a C7-10 alkane is to contribute to the composition as a whole rather than any particular limitation on the identity of that component. Applicants are reminded that art 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. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434-35 (Fed. Cir. 2000)(indicating that claim language has no separate limiting effect if, for example, “the language merely gives a descriptive name to the set of limitations in the body of the claim that completely set forth the invention.”). Claim 6 narrows the identity of the alkane to isohexadecane, Claim 8 the EDTA to disodium EDTA, and Claim 9 the buffer to citric acid or a salt thereof. Claim 10 includes the elected atropine as a pharmaceutical ingredient. Claim 14 requires the composition contain isohexadecane, EDTA disodium salt, and potassium citrate. Claims 18 and 20 specify the pH of the composition.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-6, 8-10, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shanler (U.S.PGPub. 2020/0188517).
Shanler describes topical cream formulations of Claim 3. (Abs); [0002]. Shanler indicates these compositions are to possess a pH between 2-7, a range overlapping and therefore rendering obvious the values of Claims 18 and 20. [0008], See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Shanler indicates that the cream compositions are emulsions, [0061], and more specifically may be of the oil-in-water type recited by Claim 4. [0073]. Atropine of Claim 10 is identified by Shanler as a representative pharmaceutical agent which may be included in the creams described. [0085]. Disodium EDTA is identified by Shanler as a representative chelating agent included in the compositions in concentrations of about 0.01% of the composition, addressing limitations of Claims 1, 8, and 14. [0088-89]. Shanler indicates emollients such as the isohexadecane of Claims 1, 5, 6, and 14 may be included in concentrations of about 1% of the weight of the composition. [0097-98]. Buffers such as citric acid or sodium citrate may be included in these creams to maintain the pH of about 3.5 or 5.5 providing buffer capacity of about 200mM, addressing limitations of Claims 1, 9, 18, and 20. [0104].
The specific combination of features claimed is disclosed within the broad teachings of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of atropine provided as an oil-in-water cream emulsion containing isohexadecane, disodium EDTA, and citric acid in the amounts and pH values claimed, anticipation cannot be found.
That being said, however, it must be remembered that “[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)). “[W]hen 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 prima facie obvious to have selected various combinations of atropine provided as an oil-in-water cream emulsion containing isohexadecane, disodium EDTA, and citric acid in the amounts and pH values claimed from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1, 3-6, 8-10, 14, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Shanler as applied to Claims 1, 3-6, 8-10, 18, and 20 above, and further in view of Riordan (U.S. PGPub. 2012/0195969).
Shanler, discussed in greater detail above, suggests atropine provided as an oil-in-water cream emulsion containing isohexadecane, disodium EDTA, and citric acid in the amounts and pH values claimed.
Shanler does not, however, describe using potassium citrate as a component of the buffer system in such topical cream compositions.
This is cured by the teachings of Riordan, which establishes that at the time the instant application was filed, potassium citrate was known to be useful as a buffer component for topical pharmaceutical emulsions. [0037; 0123].
It would have been prima facie obvious to have used potassium citrate as the buffer component in the atropine emulsions taught by Shanler owing to the art-recognized utility of potassium citrate as buffer components in topical emulsions. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)(Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use.).
Response to Arguments
Applicant's arguments filed 21 July 2026 have been fully considered but they are not persuasive.
Applicants assert that there is no motivation to select from the discrete teachings of Shanler the specific combination of components known in the art as usefully included in topical cream formulations, as Applicants allege the purposes of the compositions of the present claims and those of Shanler differ. Specifically, Applicants assert, the present claims are directed to compositions which may deliver an active agent through the skin to the eye tissue, whereas Shanler merely describes cream compositions containing the same ingredients claimed for topical application to the eyelid. This is irrelevant to the proper obviousness analysis, as it has long been held that the reason or motivation to modify a prior art 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. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). Here, applicants oil-in-water cream emulsion formulations are suggested by Shanler. Nothing more is needed for a prima facie case of obviousness.
Applicants assert that isohexadecane is one among many alternative emollients Shanler describes as emollients useful in the cream compositions therein suggested. Once more, Applicants assert an irrelevant issue, as it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Finally, Applicants assert that the compositions of the instant application provide unexpected results on the basis of analyses of “Formulation 5” and “Formulation 6” which applicants assert demonstrate synergistic drug delivery on the basis of the data provided by “Fig. 5” and “Fig. 6” of the disclosure as originally filed. Applicants are reminded that even if we agreed that the claimed composition provided synergistic results, a position the Examiner does not adopt, more would be required to show nonobviousness, as synergism is not per se unexpected. See In re Diamond, 360 F. 2d 214, 218 ( CCPA 1966). (“What section 103 requires is ‘unexpected synergism’ ... “ (pg. 216, n.7); “we attribute no magic status to synergism per se since it may be expected or unexpected"” (pg. 218). Synergy, broadly understood, is the observation of supra-additive results achieved by a particular combination. Here, each of the citrates, alkanes such as the presently claimed isohexadecane, and EDTA of the claims are understood by the skilled artisan to each represent permeation enhancers suitable for use in the ocular area to drastically improve the uptake and delivery of drug applied to the surface of the eyelid for the treatment of even posterior segment ocular diseases. See Bosworth (U.S. PGPub. 2019/0151334) [0010; 0035; 0079]. As three known permeation enhancing agents are being combined in applicant’s compositions, an increased permeation of drug observed by a composition containing three penetration enhancers compared to a similar composition containing only two cannot, without more, serve to establish that such an improvement is unexpected.
Moreover, applicants comparison of “Formulation 5” and “Formulation 6” suffers from additional flaws. The data provided via these two compositions does not permit a skilled artisan to determine what effect, if any, each of the known penetration enhancers has individually on the uptake of drugs delivered in such a manner, rendering a proper isobolographic analysis of the asserted synergy on the basis of these examples impossible. Moreover, Formulation 5 combines 66.823% of a 10mM potassium citrate buffer with 0.2% disodium EDTA and 2% of a 20-25% isohexadecane composition, while Formulation 6 lacks the citrate and the isohexadecane, while containing only 0.02% disodium EDTA. Particular significance concerning non-obviousness cannot be ascribed to those examples since the compositions of the two examples do not have such correspondence that the improved results can be traced, within a reasonable certainty, to the particularly claimed combination. It is not an unreasonable burden on applicants to require comparative examples relied on for non-obviousness to be truly comparative. The cause and effect sought to be proven is lost here in the welter of unfixed variables. In re Dunn, 349 F.2d 433, 439 (CCPA 1965). Moreover, applicants are reminded that once the examiner establishes a prima facie case of obviousness, the burden shifts to the applicant to rebut that case. In re Kao, 639 F.3d 1057, 1066 (Fed. Cir. 2011). When unexpected results are proffered, Applicants must “provide an adequate basis to support the conclusion that other embodiments falling within the claim will behave in the same manner” in order to “establish that the evidence is commensurate with [the] scope of the claims.” Id. at 1068. One data point is insufficient to “to ascertain a trend in the exemplified data which would allow [one having ordinary skill in the art] to reasonably extend the probative value thereof.” In re Kollman, 595 F.2d 48, 56 (Fed. Cir. 1979).
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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