DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This office action is in response to applicant’s communication of 7/28/2026. Currently claims 1-20 are pending and rejected below.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Lyman et al. (US 2022/0395457 A1).
Lyman discloses a dry powder pharmaceutical composition, comprising: epinephrine or a pharmaceutically acceptable salt thereof; and a carrier; (see paras [0010-0015]) wherein a dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof (para [0012], [00170]); and wherein the dose of the dry powder pharmaceutical composition results in at least one of:(A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or (B) a time to reach a maximum epinephrine plasma concentration (Tmax) is greater earlier than a Tmax of the first reference dose and [[less]] later than a Tmax of the second reference dose; wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector (see para [0173], [0714], [0177], [0265-0266], [0268]). It is examiners position that the claim language following “…composition results in a t least one of:…” is a functional limitation of the composition structure. Examiner is of the position that the results would occur depending on the methodology of using the disclosed Lyman composition and the particular administration of the Lyman composition.
Concerning claim 2 and pharmaceutical composition does not include an alpha-adrenergic blocker (see paras [0166]-0167]).
Concerning claim 3 and the carrier includes lactose monohydrate (see paras [0217]).
Concerning claim 4 and comprising at least one or more agents selected from a group consisting of a mucosal permeation or penetration enhancer, a mucoadhesive, a mucosal transit slowing agent, a mucosal transport enhancer, or any combination thereof (see paras [0149], [0184], [0191]).
Concerning claim 5 and the dry powder pharmaceutical composition is formulated such that delivery of the dose of the dry powder pharmaceutical composition produces a dry powder spray having an emitted particle size distribution characterized by a Dv50 of between about 20 microns and about 100 microns (See para [0228], [0298], [0299]).
Concerning claim 6 and the dry powder pharmaceutical composition has a moisture content of between about 3% and about 6% (see para [0401] figure 126 and batch 2 at 4%).
Concerning claim 7 and a baseline-corrected epinephrine concentration present in the body is at least 100 pg/mL after about 5 minutes after delivery of the dose (Examiner is of the position that the results on the body of the delivery of the dose would occur depending on the methodology of using the disclosed Lyman composition and the particular administration of the Lyman composition).
Concerning claim 8 and a dry powder pharmaceutical composition, comprising: epinephrine or a pharmaceutically acceptable salt (see paras [0010-0015]) thereof; wherein a dose of the dry powder pharmaceutical composition contains about 2.0 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof (para [0012], [00170]); and wherein the dose of the dry powder pharmaceutical composition results in at least one of:(A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or (B) a time to reach a maximum epinephrine plasma concentration (Tmax) is greater earlier than a Tmax of the first reference dose and [[less]] later than a Tmax of the second reference dose; wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector. It is examiners position that the claim language following “…composition results in a t least one of:…” is a functional limitation of the composition structure. Examiner is of the position that the results would occur depending on the methodology of using the disclosed Lyman composition and the particular administration of the Lyman composition.
Concerning claim 9 and the dry powder pharmaceutical composition has a moisture content of between about 3% and about 6% (see para [0401] figure 126 and batch 2 at 4%).
Concerning claim 10 and the dry powder pharmaceutical composition is formulated such that delivery of the dose of the dry powder pharmaceutical composition produces a dry powder spray having an emitted particle size distribution characterized by a Dv50 of between about 20 microns and about 100 microns (See para [0228], [0298], [0299]).
Concerning claim 11 and the pharmaceutical composition does not include an alpha-adrenergic blocker (see paras [0166]-0167]).
Concerning claim 12 and a baseline- corrected epinephrine concentration present in the body is at least 100 pg/mL after about 5 minutes after delivery of the dose (Examiner is of the position that the results on the body of the delivery of the dose would occur depending on the methodology of using the disclosed Lyman composition and the particular administration of the Lyman composition).
Concerning claim 13 and further comprising a carrier (see paras [0012-0013]).
Concerning claim 14 and at least one or more agents selected from a group consisting of a mucosal permeation or penetration enhancer, a mucoadhesive, a mucosal transit slowing agent, a mucosal transport enhancer, or any combination thereof (see paras [0149], [0184], [0191]).
Concerning claim 15 and a dry powder pharmaceutical composition, comprising: epinephrine or a pharmaceutically acceptable salt thereof; a carrier (see paras [0010-0015]); and a citrate (para [0214]) ;wherein a dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof (para [0012], [00170]); and wherein the dose of the dry powder pharmaceutical composition results in at least one of:(A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or (B) a time to reach a maximum epinephrine plasma concentration (Tmax) is greater earlier than a Tmax of the first reference dose and [[less]] later than a Tmax of the second reference dose; wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector. It is examiners position that the claim language following “…composition results in a t least one of:…” is a functional limitation of the composition structure. Examiner is of the position that the results would occur depending on the methodology of using the disclosed Lyman composition and the particular administration of the Lyman composition.
Concerning claim 16 and the dry powder pharmaceutical composition has a moisture content of between about 3% and about 6% (see para [0401] figure 126 and batch 2 at 4%).
Concerning claim 17 and the dry powder pharmaceutical composition is formulated such that delivery of the dose of the dry powder pharmaceutical composition produces a dry powder spray having an emitted particle size distribution characterized by a Dv50 of between about 20 microns and about 100 microns (See para [0228], [0298], [0299]).
Concerning claim 18 and the carrier includes lactose monohydrate (see paras [0217]).
Concerning claim 19 and wherein the pharmaceutical composition does not include an alpha-adrenergic blocker (see paras [0166]-0167]).
Concerning claim 20 and wherein a baseline- corrected epinephrine concentration present in the body is at least 100 pg/mL after about 5 minutes after delivery of the dose (Examiner is of the position that the results on the body of the delivery of the dose would occur depending on the methodology of using the disclosed Lyman composition and the particular administration of the Lyman composition).
Response to Arguments
Applicant's arguments filed 7/28/2026 have been fully considered but they are not persuasive. Applicant’s argue that the prior art fails to disclose or teach “wherein the dose of the dry powder pharmaceutical composition results in at least one of: (A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or (B) a time to reach a maximum epinephrine plasma concentration (Tmax) is earlier than a Tmax of the first reference dose and later than a Tmax of the second reference dose; wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector."
In response to applicant's argument that the above claim limitations are not taught in Lyman and Lyman fails to teach two separate reference dosages , a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure (or in this claim the pharmaceutical composition) is capable of performing the intended use, then it meets the claim.
It is well established that a recitation with respect to the manner in which an apparatus (or in this claim the pharmaceutical composition) is intended to be employed, i.e., a functional limitation, does not impose any structural limitation upon the claimed apparatus which differentiates it from a prior art reference disclosing the structural limitation of the claim. Where the prior art reference is inherently capable of performing the function described in a functional limitation, such functional limitation does not define the claimed apparatus over such prior art reference, regardless of whether the prior art reference explicitly discusses such capacity for performing the recited function. In addition, where there is reason to believe that such functional limitation may be an inherent characteristic of the prior art reference, applicant is required to prove that the subject matter shown in the prior art reference does not possess the characteristic relied upon.
Examiner is of the position that the above is true and that Lyman does disclose a dry powder pharmaceutical composition, comprising:epinephrine or a pharmaceutically acceptable salt thereof; anda carrier;wherein a dose of the dry powder pharmaceutical composition contains about 3.5 mg to about 5.5 mg of the epinephrine or the pharmaceutically acceptable salt thereof (as discussed in the rejection above), and that that positively claimed pharmaceutical composition of Lyman is inherently capable of the functional limitaitons of “wherein the dose of the dry powder pharmaceutical composition results in at least one of: (A) a relative mean maximum epinephrine plasma concentration after the dose is delivered into the body (Cmax) is greater than a Cmax of a first reference dose and less than a Cmax of a second reference dose, or (B) a time to reach a maximum epinephrine plasma concentration (Tmax) is earlier than a Tmax of the first reference dose and later than a Tmax of the second reference dose; wherein the first reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via a manual injection and the second reference dose contains about 0.3 mg of epinephrine or a pharmaceutically acceptable salt that is delivered intramuscularly via an autoinjector.".
Examiner recommends applicant amend the claims to greater define physical or structureal differences to distinguish over the prior art Lyman or greater claim functional limitations of the positively claimed structural/physical elements that the Lyman prior art is not capable of.
Amending the claims to greater distinguish over the prior art of record particularly Lyman is recommended.
Conclusion
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 PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783
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