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
This application was filed 01/15/2022 and claims priority to PRO 63/137881 (01/15/2021). RCE papers were filed 12/8/2025. Claims 1-16, 18, 21, 22, 24-48 and 53-60 are before the Examiner.
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.
Claims 1-16, 18, 21-22, 24-33, 36-48 and 53-60 are rejected under 35 U.S.C. 103 as being unpatentable over Schobel USPGPub 2019022023 and WO2018058201. Both Schobel and WO teach a delivery device and methods of using that device for delivering epinephrine or its prodrug form (WO paragraph 0047, Schobel paragraph 005). The treatment of anaphylaxis is taught in WO paragraph 048 and Schobel paragraph 0038.Both wo and Schobel teach the use is as an inhaler. Both teach a housing as an inhaler. With a propellant and a nebulizer (WO paragraph 103). WO discusses using vibration with an aerosol in paragraph 17. Claim 25 requires a device comprising 1) housing and 2)pharmaceutical composition within the housing that includes a prodrug of epinephrine and a carrier gas wherein the prodrug is of formula (I). Schobel teaches (paragraph 0034) a housing that holds an amount of a pharmaceutical composition. If the housing “holds” the composition, then the composition must be within the housing. Paragraph 0033 teaches the pharmaceutical composition includes epinephrine or its prodrug. Paragraph 0032 teaches the pharmaceutical composition includes a carrier which is a selective transport-enhancing agent. Paragraph 0034 teaches that the pharmaceutical composition can be dispensed from a device that includes a housing that holds the composition. The instant specification contains no definition of “dry powder inhalation carrier gas”. Due to this, paragraph 0032 teaches a carrier that fits the instant claim. Claim 26 includes that the composition consists of essentially the prodrug of epinephrine. Schobel teaches that depifevrin is in the composition in paragraph 0005 which is a prodrug of epinephrine. Claim 27 includes an alkyl ester of epinephrine. Depifevrin is an alkyl ester prodrug of epinephrine. Claim 28 includes a butyl ester of a pharmaceutically active compound. Depifevrin has iso-butyl ester of epinephrine. Claims 29-31 includes an isopropyl or ethyl or ester of the pharmaceutical active compound. Schobel teaches in paragraph 0119, 0005 and in the abstract and claims that any prodrug of epinephrine are included in the pharmaceutical composition. Claims 32-33 and 39 include more than one prodrug of epinephrine. Schobel teaches that multiple prodrugs can be used (see paragraph 0086). Claims 36-37 has that the housing includes a blister-based housing with a preloaded unit dose of a powder. Schobel teaches that the dry composition can be encapsulated (paragraphs 032, 0072, 0114, 0124 and 0130). Claim 38 has epinephrine and a prodrug. The title has both epinephrine and a prodrug of epinephrine. The art cited does not specify the ratio (claim 42-48 and 53-60) of the dosage of epinephrine or its prodrug or the plasma concentration of the drug. However, it would have been obvious to one of ordinary skill in the art at the time of the invention that the dosage of epinephrine would be sufficient to treat anaphylaxis from an allergic reaction since both art cited state that the composition in the inhaler format are enough to treat anaphylaxis in a mammal. The exact epinephrine or prodrug used in the composition with well within the skill of the ordinary artisan to choose from the known drug and prodrug formulations.
The rejection of claims 1-16, 18, 21, 22, 24-33, 36-48 and 53-60 under 35 U.S.C. 103 over Schobel (USPGPub 20190022023) or Cifter (USPGPub 20150202148) in view of Wensley (US Pat 7766013, as stated in paper dated 03/16/2026, is upheld. The rejection is shown below:
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Applicant argues that an inhalation pharmaceutical composition is not a simple task. However, Schobel teaches an inhalation pharmaceutical composition of epinephrine and epinephrine prodrugs to treat anaphylaxis. This is the same as applicant’s instant claims. Schobel teaches that the composition can be administered orally by inhalation. When the composition is inhaled, the inhaler gas is air. Cifter teaches a carrier for a dry powder inhaler (paragraph 0009). These together make obvious the instant invention. Applicant argues that there is nothing is Cifter that teaches a prodrug of epinephrine and a dry powder inhalation carrier gas. However, there is no definition of what a dry powder inhalation carrier gas in the instant specification. Due to this, air can be the carrier gas. Appliant teaches that dry powder inhalers are known in the prior art such as taught by US Patents 7766013, 9107832, 10004858 and 9192675. No definition of how “dry powder inhalation carrier gas” is different from what is known in the cited prior art.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The rejection of claims 1-16, 18, 21, 22, 24-33, 36-39 and 53-60 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, as stated in paper dated 03/16/2026, is upheld.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. The courts have stated:
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A stated supra, the MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. Claims 1-16, 18, 21, 22, 24-33, 36-39 and 53-660 are generic, with respect to all possible “dry powder inhalation carrier gas”. According to the specification, “carrier gas” (page 7 line 25) “…can be provided by an external source, such as a propellant, or by inhalation, or combinations thereof…”. There is no presentation in the instant specification of the phrase added to claim 1 of –a dry powder inhalation carrier gas-- . The closest is the above defined carrier gas. The possible variations of “propellant” are limitless. The claims lack written description because there is no disclosure of a correlation between function and form of the propellants. There is insufficient description of a “dry powder inhalation carrier gas” that would allow one of skill in the art to practice the invention as claimed.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed.Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”)
Accordingly, it is deemed that the specification fails to provide adequate written description for the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
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