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
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.
Response to Arguments
Applicant’s argue in paper dated 12/18/2025 that the finality of the office action dated 06/18/2025 should be withdrawn. This argument is considered moot in view of the RCE papers filed 12/18/2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
The rejection of claims 40-48 under 35 U.S.C. 101 because the claimed invention lacks patentable utility, as stated in paper dated 06/18/2025, is upheld. As previously stated, the claims are drawn to treating a non-specific medical condition. Applicants have argued that the medical condition being treated is anaphylaxis. However, anaphylaxis is not stated in the claims and the claims are not limited to treating anaphylaxis. The claims are “limited” to treating “a medical condition” which can be any known medical condition from anaphylaxis to toe fungus to hair loss. It is suggested that the claims be limited to the treatment of anaphylaxis.
Claim Rejections - 35 USC § 112
The rejection of claims 1-16, 18, 21-22 and 24-60, under 35 USC 112(a) or 35 USC 112 (pre-AIA ), first paragraph as failing to comply with the written description requirement, as stated in paper dated 06/8/2025, is upheld for reasons of record. Further, claim 1 (as well as claim 25) has the various R groups ”can be H or C1-6 acyl”. “Can be” is not limiting language. Therefore, the different R groups can be hydrogen or C 1-6 acyl or they can also be CN or quinoline or morpholine or anything else. It is not seen where there is written description for these variables in the instant specification for the current language in the claims. To overcome this rejection, claims 1 and 25 need to be rewritten such that “…R1a, R1b, R2 and R3 are independently selected from H and C1-6 acyl, provided that one of R1a, R1b, R2 and R3 is not H”.
The rejection of claims 5, 8, 13-16, 25, 27-32, 34, 37 and 54-58 under 35 USC 112(b) or 35 USC 112(pre-AIA ), second paragraph, as stated in paper dated 06/18/2025, is withdrawn in view of applicant’s amendments and arguments in paper dated 12/18/2025.
The rejection of claims 49-52 under 35 USC 112(d) or 35 USC 112(pre-AIA ), fourth paragraph, as stated in paper dated 06/18/2025, is withdrawn in view of applicant’s amendments in paper dated 12/18/2025.
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 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 –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The rejection of claims 25-33 and 36-39 under 35 U.S.C. 102(a)(2) as being anticipated by Schobel (USPGPub 20190022023) as stated in paper dated 06/18/2025 is upheld for reasons of record. Applicants argue in paper dated 12/18/2025 that the claims are not anticipated by the prior art. 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. This anticipates claim 25. 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. Schobel anticipates the instant claims.
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 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 06/18/2025, 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.
New Rejections:
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.
Claims 1-16, 18, 21, 22, 24-33, 36-39 and 53-60 are rejected 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. 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.
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.
Claims 40-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue”. These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention: The nature of the invention is the method of treating a medical condition.
The state of the prior art: The state of the prior art is that it involves screening in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. what compounds can treat which specific disease). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face. Epinephrine is known in the art to treat conditions such as anaphylaxis, cardiac arrest, asthma and septic shock. However, there is no showing of epinephrine or its prodrugs treating medical conditions such as toe fungus, cancer or tendonitis.
The predictability in the art: It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F. 2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instantly claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to the therapeutic effects of all diseases, whether or not the use of epinephrine or its prodrugs would make a difference in the disease. Hence, in the absence of a showing of a nexus between any and all known diseases and epinephrine or its prodrugs, one of ordinary skill in the art is unable to fully predict possible results from the administration of the compound of claim 1 due to the unpredictability of the role of epinephrine or its prodrugs.
The presence or absence of working examples: There are no working examples of the pharmaceutical composition treating any specific condition other than anaphylaxis.
The amount of direction or guidance present: The guidance present in the specification is that epinephrine and its prodrugs treat anaphylaxis.
The breadth of the claims: The claims are drawn to the treatment of medical conditions with epinephrine and its prodrugs.
The quantity of experimentation needed: The quantity of experimentation needed is undue. One skilled in the art would need to determine what diseases out of all known diseases would be benefited by the mediation of epinephrine and its prodrugs and then would further need to determine which of the claimed compounds would provide treatment of the disease.
The level of the skill in the art: The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of claim 1 for the treatment of any disease. As a result necessitating one of ordinary skill to perform an exhaustive search for which diseases can be treated by which compound of claim 1 in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, one of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by the compounds of the instant claims, with no assurance of success.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625