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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1 and 3-19 in the reply filed on 12 February 2026 is acknowledged.
Further acknowledgement is made of applicant’s election of atropine as the active pharmaceutical ingredient of Claims 1, 3-6, 8-10, 14, and 18.
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Claims 2, 7, 11-13, 15-17, 19, and 21-25 are withdrawn from consideration as directed to non-elected inventions.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.
Priority
The instant application claims the benefit of Provisional U.S. application 63/392,266 filed 26 July 2022.
Claim Interpretation
Applicants Claims are directed to compositions combining defined concentrations of each of a C7-10 alkane, metal chelating agent, 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 chelating agent to 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.).
Conclusion
No Claims are allowable.
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.
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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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