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 19 September 2022 and is the national stage entry of PCT/CN2021/082173filed 22 March 2021. The Applicant claims priority to PCT/CN2020/080477 filed 20 March 2020. An English copy of the document has been provided. The effective filing date of the instant application is 20 March 2020.
Examiner’s Note
The Applicant's amendments and arguments filed 12 March 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 12 March 2026, it is noted that claim 1 has been amended. Support for the amendment can be found on pg. 3 of the specification. No new matter has been added.
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, 3-5, 9-12, 15, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu (WO 2010065936 A1).
Yu teaches methods for improving efficiency of delivery of drug compounds to a subject (entire teaching; para. 12; abs). The method and composition may comprise high penetration drugs in an aqueous and/or ethanol carrier (para. 174, 175). The high penetration compound may be a peptide (para. 15), such as Leu-enkephalin (H-Tyr-Gly-Gly-Phe-Leu-OH) (para. 20) and may be in its salt form (para. 84). A linker may link a functional unit to the drug through a bond, such as an ester bond (para. 23) with an isopropyl alkyl group (para. 87), which is interpreted as addressing Applicant’s election of H-Tyr-Gly-Gly-Phe-Leu-OCH(CH3)2.HCl in claim 20. The compound and Applicant’s election is interpreted as addressing the protonated amine group limitation of claim 1. The composition may be provided as a kit, typically as dry powders, that may be reconstituted later with solution (para. 128) before administration to a patient (para. 174). The components packaged as dry powders to be later reconstituted before administration is interpreted as being contained in separate containers, addressing the limitation in claim 1. In one embodiment, the pH of one formulation is adjusted to 4-7 (para. 294). The method and composition thus far address the limitations in claims 1, 3-5, 12, and partially claims 19 and 21. The composition may further comprise pH adjusting and buffering agents, such as sodium acetate (para. 107), addressing claims 9-11 and 21. The amount of drug can be 0.0001-100% (para. 109), which addresses claims 15, 19, and 21. The amount of ethanol in water may vary, such as 25% (para. 241-242) or 70% ethanol (para. 214), addressing claims 19 and 21.
Yu does not teach an exact combination of steps recited in claim 1.
In regards to selecting the combination of packing and reconstituting the formulation comprising high penetration compound with a carrier, “[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.”
Yu teaches methods for improving efficiency of delivery of drug compounds that may comprise high penetration drugs in an aqueous and/or ethanol carrier, whereas the claimed invention is directed towards a method for improving the stability of a composition comprising a high penetration drug substance and pharmaceutically acceptable carrier. Since Yu 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.
Claim(s) 1, 3-5, 8-12, 15, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu (WO 2010065936 A1) and lifetein.com.
In regards to claim(s) 1, 3-5, 9-12, 15, 19-21, Yu, as applied supra, is herein applied in its entirety for its teachings of methods for improving efficiency of delivery of drug compounds that may comprise high penetration drugs in an aqueous and/or ethanol carrier.
Yu does not specifically teach storing the solution at a temperature of 2-8 °C in claim 8.
Lifetein.com teaches that peptide solutions may be stored at a temperature of 4 °C (pg. 2).
Since Yu does not specifically teach storing the solution at a temperature of 2-8 °C in claim 8, one of ordinary skill in the art would have been motivated to use lifetein.com’s teaching that peptide solutions may be stored at a temperature of 4 °C with a reasonable expectation of success. A skilled artisan would have been led to combine the teachings since a peptide solution would likely be used shortly after reconstitution and lifetein.com teaches that a temperature of 4 °C will suffice for short-time storage.
Response to Arguments
Applicant's arguments filed 12 March 2026 have been fully considered but they are not persuasive.
The Applicant argues that even with selecting the various combinations from Yu, the technical features disclosed in Yu would still fail to arrive at the subject matter of instant claim 1 (Remarks, pg. 7-8).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When 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”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
The Applicant argues that Yu is silent on the stability of the recited high-penetration drug (Remarks, pgs. 8-9).
Applicant’s argument is not found persuasive. Yu teaches incorporating auxiliary agents, such as pH adjusting and buffering agents (para. 107). A skilled artisan would know that adjusting the pH by using buffering agents helps to stabilize solutions comprising active agents. Therefore, the instant claims are obvious in view of Yu’s teaching of using said pH adjusting and/or buffering agents to improve the stability of the composition.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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