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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 June 2026 has been entered.
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 10 June 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not reiterated from previous office actions are hereby withdrawn.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 10 June 2026, it is noted that claim 1 has been amended. Support for the amendment can be found on pg. 4 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, 8-12, 15, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu (WO 2010065936 A1) and elvalabs.co.
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. Yu does not teach administering the reconstituted peptide after more than a month in claim 1. Yu does not specifically teach storing the solution at a temperature of 2-8 °C in claim 8.
Elvalabs.co teaches that, in general, reconstituted peptides may be stored at 2-8 °C and used within 4 weeks (pgs. 1-2).
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.
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 elvalabs.co’s teaching that peptide solutions may be stored at a temperature of 2-8 °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 elvalabs.co teaches that a temperature of 2-8 °C for storage will provide optimal stability.
In regards to the storage limitation of more than a month, elvalabs.co teaches that, in general, reconstituted peptides may be stored in refrigerated conditions for 4 weeks (pgs. 1-2). That being said and in lieu of objective evidence of unexpected results, the storage time can be viewed as a variable that achieves the recognized result of successfully performing the method of using a composition comprising a high penetration drug substance, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of elvalabs.co. The optimum or workable range for the storage time 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 length of time as nonobvious.
Response to Arguments
Applicant's arguments filed 10 June 2026 have been fully considered but they are not persuasive.
The Applicant argues that Yu teaches that their solutions are reconstituted just prior to use, compared to the amended limitation of administering the reconstituted solution after a month of storage, as recited in claim 1 (Remarks, pgs. 7-8).
Applicant’s argument is not found persuasive. A skilled artisan would have been easily motivated to provide proper storage conditions for peptides, as they are known in the art to degrade easily if improperly stored (genscript.com, pg. 3). In regards to the storage limitation of more than a month, elvalabs.co teaches that, in general, reconstituted peptides may be stored in refrigerated conditions for 4 weeks (pgs. 1-2). That being said and in lieu of objective evidence of unexpected results, the storage time can be viewed as a variable that achieves the recognized result of successfully performing the method of using a composition comprising a high penetration drug substance, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of elvalabs.co.
The Applicant argues that there is no motivation to improve the stability of the high-penetration drug and to arrive at the recited steps in claim 1 (Remarks, pg. 8).
Applicant’s argument is not found persuasive. Yu teaches methods for improving efficiency of delivery of drug compounds to a subject (entire teaching; para. 12; abs), where improving the stability of a drug is interpreted as directly improving the efficiency or efficacy of a drug compound (Blessy et al., pg. 159). In regards to the limitation of using the reconstituted solution more than a month after reconstitution and storage, a skilled artisan would have been easily motivated to provide proper storage conditions for peptides, as they are known in the art to degrade easily if improperly stored (genscript.com, pg. 3). In regards to the storage limitation of more than a month, elvalabs.co teaches that, in general, reconstituted peptides may be stored in refrigerated conditions for 4 weeks (pgs. 1-2). That being said and in lieu of objective evidence of unexpected results, the storage time can be viewed as a variable that achieves the recognized result of successfully performing the method of using a composition comprising a high penetration drug substance, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of elvalabs.co.
The teachings from lifetein.com have been removed as prior art and the arguments against them will not be addressed.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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