-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 .
Applicant’s response dated February 4, 2026 to the restriction requirement, is acknowledged.
Priority
This application is a 371 of PCT/US22/38226 filed on 07/25/2022, which claims benefit in provisional applications 63/226,753 filed on 07/28/2021 and 63/225,923 filed on 07/26/2021.
Claims Status
Claims 64-84 are pending. Claims 1-63 were canceled. Claims 64-69 and 73-84 are withdrawn. Claims 70-72 are examined.
Election/Restriction
Applicant’s election without traverse of Group II (Claims 70-72), drawn to a method in the reply filed on February 4, 2026, is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 64-69 and 73-84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Response to the restriction requirement of November 5, 2025 was timely filed.
Claims 70-72 are examined on the merits.
Claim Rejections – 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 71 and 72 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 71 and 72 recite “an acidic solution comprising a pH at or below about 7, optimally in the range of about pH 2-6.5”. The claims are indefinite because it is not clear if the embodiment is limited to the optimal narrower range “2-6.5” or the broad range of “below about 7”.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Yanagawa (US 2006/0110333 A1 Published May 25, 2006).
The claims encompass a method of treating a disease or disorder in a subject in need thereof, the method comprising nasally administering a therapeutically effective amount of the composition of claim 64 to a subject in need thereof, the composition comprising a pharmaceutical agent admixed with or coated with a propulsion agent comprising a component capable of evolving a propulsion gas upon contact with an active agent, thereby allowing the pharmaceutical agent to embed within or penetrate a biological tissue or biological barrier.
The teachings of Yanagawa are related to a composition for intranasal administration, wherein the composition comprises a carrier of calcium carbonate and an effective dose of an opioid analgesic uniformly distributed and attached to the carrier (Abstract). Example 1 teaches a composition for nasal absorption was prepared by using morphine hydrochloride and calcium carbonate, where the two components were combined with rice powder and water for freeze drying, the mixture was kneaded and freeze dried (paragraphs 0052 and 0053). A group of three rhesus monkeys were transnasally administered with a single dose of the composition (paragraph 0054). The composition for intranasal administration provided a markedly reduced risk of developing side effects compared to conventional oral, percutaneous, and transrectal formulations, and which exhibit prompt analgesic effects as well as excellent bioavailability. In particular, the prompt analgesic action after the administration attained by the intranasal administration is effective in swiftly ameliorating cancer pain of the terminal cancer patients and such action is effective not only for the continuous pain but also for the incident pain (paragraph 0089).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have transnasally administered the composition of example 1 to a patient suffering from cancer pain, with a reasonable expectation of success because Yanagawa teaches that the composition comprising morphine hydrochloride and calcium carbonate is suitable for treating cancer pain via transnasal administration. The composition in Example 1 renders the claimed composition obvious because it is a pharmaceutical composition comprising: morphine hydrochloride (pharmaceutical agent) admixed with calcium carbonate (a propulsion agent comprising a component capable of evolving a propulsion gas upon contact with an activation agent; thereby allowing the pharmaceutical agent to embed within or penetrate a biological tissue or biological barrier). As evidenced by instant specification, calcium carbonate is an example of a propulsion agent, and it would have been reasonable to expect the calcium carbonate to have all of the claimed properties because a chemical composition and its properties are inseparable. A patient suffering from cancer pain is a subject in need of the treatment, and a method of administering the composition to said patient is a method of treating a disease or disorder in a patient in need of the treatment. It would have been obvious to have administered the composition in an amount that is effective for treating the pain.
Claims 70-72 are rejected under 35 U.S.C. 103 as being unpatentable over Loebenberg (US 7,947,308 B2 Date of Patent May 24, 2011 – of record in IDS dated 05/13/2025).
The teachings of Loebenberg are related to effervescent inhalable powders comprising an inorganic or organic carbonate, and an acid, and exhibit effervescence when exposed to water. The inhalable powders are suitable for nasal administration and may be used to enhance permeability of mucosal and surface barriers on an inner surface of the nose of a patient in need thereof (Abstract). In another embodiment, the particles may act as carrier particles for an active agent. The term "carrier particles" as used herein is meant to include effervescent particles which contain an active agent and act as a carrier for the active agent, as well as effervescent particles which do not contain an active agent. The carrier particles may be inhaled via the nose or mouth (column 6 lines 47-53). The in situ formation of gas forces the carrier particles to burst and release carbon dioxide gas. The formation of small bubbles redestributes drugs or nano-materials which can be incorporated into the carrier particles throughout the gas bubbles. The effervescent reaction can be used to create airborne nano- or micro-droplets containing molecules or active principles in nano- or micro-meter scale. The effervescent reaction can also be used to interact with the mucus layers of the respiratory tract (column 7 lines 28-38). Suitable acids and carbonates, including calcium carbonate, are described in column 7 lines 54-67. Active agents for incorporation into the carrier include active materials useful for therapeutic purposes. These may include drugs, amino acids, proteins, peptides, polypeptides, diagnostics, imaging agents, enzymes, radiopharmaceuticals, nucleotides, nutrition, vitamins, hormones, immunomodulating agents, cytokines, antibodies, anti-bacterial agents, antiviral agents, mucolytic agents, bioadhesive agents, and vaccines (column 8 lines 48-55).
Regarding claim 70, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have formed an effervescent powder composition comprising an organic or inorganic carbonate, an acid, and an active agent, and administered the composition nasally to a patient in need thereof, with a reasonable expectation of success because Loebenberg teaches forming an effervescent composition in the form of a powder, the composition comprising an organic or inorganic carbonate, an acid, and an active agent wherein the composition is nasally administered to a patient in need thereof. It would have been obvious to have selected an antibacterial agent such as ciproflaxin because Loebenberg teaches that the effervescent composition is suitable for delivering antibacterial agents where ciproflaxin is a suitable antibacterial (Example 2 columns 15-16). Ciproflaxin is a known antibiotic intended for treating bacterial infection, therefore it would have been obvious to have used it in a method of treating a patient having a bacterial infection, which reads on treating a disease or disorder in a patient in need thereof. The effervescent composition meets all of the limitations of claimed composition because it contains an active agent and an inorganic or organic carbonate (a propulsion agent). It would have been obvious to have selected calcium carbonate because Leobenberg teaches that calcium carbonate is suitable for making the effervescent composition. As evidenced by applicant’s specification, calcium carbonate is an example of a propulsion agent, and it would have been reasonable to expect it to have the same properties as claimed propulsion agent because a chemical composition and its properties are inseparable. It would have been obvious to have administered a therapeutically effective amount of the composition because the purpose of the method is to treat the disease, and the skilled artisan would have been capable of determining such amount.
Regarding claims 71 and 72, it would have been obvious to have nasally administered water after administering the powder in order to cause the powder to effervesce because Loebenberg teaches that the composition effervesces after contacting water. While, Loebenberg does not explicitly teach the step of administering water, however the step of administering water is implied and the skilled artisan would have recognized that administering water would have been required in order to cause the composition to effervesce.
The last three “wherein” clauses in claim 71 describe the effects of the claimed method, and it would have been reasonable to expect Loebenberg’s method to have the same effects as claimed because Loebenberg’s method teaches the same method steps as claimed. See MPEP 2111.04(I).
Conclusion
No claims are allowed.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617