DETAILED ACTION
1. 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 election without traverse of Group I in the reply filed on 11/24/2025 is acknowledged.
Claims 25,28,32,33,36 and 37 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/24/2025.
INFORMATION DISCLOSURE STATEMENT
2. Information Disclosure Statements filed 11/24/2025 is acknowledged.
Claim Rejections- 35 USC § 112
3. 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 19, 49 and 52 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.
Claim 19 recites (1 bar/4 bar) and (RODOS/HELOS system) in parenthesis and the parenthesis renders the claim indefinite because it is not clear if these limitations are part of the claim or not. It is suggested to remove the parenthesis.
Claim 49 recites the amounts (0 % by weight) in parenthesis and it is not clear if these limitations are part of the claim or not and thus the metes and bounds of the claim are unclear. It is suggested to remove the parenthesis. Claim 52 does not cure this deficiency.
Claim Rejections- 35 USC § 103
4. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4-5, 43 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20100081664) in view of Perry et al. (US 20200129428).
Cook et al. (US 20100081664) (hereinafter Cook et al.) teach a dry powder and pulmonary administration of DHE in a powder formulation with excipients and discloses the addition of sodium or potassium chloride (cation salt as stabilizer) (paras 0075, 0079, example 4, claim 56). Dihydroergotamine mesylate is disclosed (Examples and Ex. 2). Amorphous form of DHE is not taught however, Perry et al. (US 20200129428) teach that amorphous forms of drug lead to increased solubility and rapid transit through the lung to the systemic circulation (para 0324). Therefore, it is prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include the drug in amorphous form for increased solubility.
The specific combination of features claimed is disclosed within the broad
generic ranges taught by the reference but such "picking and choosing" within several variables does not necessarily give rise to anticipation. Corning Glass Works V.
Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989).
However, it must be remembered that "[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)). "[W]hen 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 V. Teleflex, 127 S.Ct. 1727, 1741 (2007). 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 prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have selected various combinations of the various disclosed dry powder with respirable dry particles comprising DHE and sodium chloride and one or more excipients yielding no more than one would expect from such an arrangement.
5. Claim 1, 3, 6-8, 19, 21, 44-47 are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20100081664) and Perry et al. (US 20200129428) as applied to claims 1, 4-5, 43 and 50 above, and further in view of Lipp et al. (US 2013/0213398) and Lipp et al. (US 20170020813).
Lipp et al. disclose excipients include leucine and mannitol. Carbohydrate excipients include mannitol and can be from 74 % or less (paras 0012, 0143, Table 4). The excipients hat include leucine and mannitol and combinations can be present at 74 % or less (para 0144). The metal salts can be from about 30 to about 60 % (para 0144-0145, Table 4).The monovalent salt is present in an amount of at least 3 % (para 0131). Th dry particles contain at least 74 % or less amino acid such as leucine (para 0140-0142). The therapeutic can be from 0.01-20 % (claims 36 and 55). The composition can have properties such as ¼ bar (para 0144). The formulation is small particle size aerosols and are dense in mass and in drug in order to maximize the quantity of drug with a given delivery container (para 0101). The excipients such as sodium chloride and mannitol reduced influenza titer at higher concentrations (para 0030). Lipp et al. disclose that these excipients are generally relatively free-flowing particulates, do not thicken or polymerize upon contact with water, are toxicologically innocuous when inhaled as a dispersed powder and do not significantly interact with the active agent in a manner that adversely affects the desired physiological action of the salts of the invention. The fine particle fraction is 56.2 % less than 5.6 microns (para 0351).
With regards to leucine, Lipp et al. (US 20170020813) (hereinafter ‘813) disclose that amino acids such as leucine are agents that disrupts and/or disperses biofilms (para 0107).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include excipients such as mannitol and leucine in the dry powder formulations of Cooke et al. because these are common excipients for use in dry powder formulations for inhalation therapy and they are free-flowing, do not interact with the active, are not toxic when inhaled.
With regards to the sodium sulfate, Lipp et al. disclose that the monovalent metal is sodium sulfate (Ex 6). Lipp ‘813 disclose monovalent cation salts and sodium salts for the respirable dry particles include sodium chloride, sodium sulfate and combinations. Lipp et al. ‘813 disclose calcium citrate, calcium sulfate and calcium lactate also have a significantly lower heat of solution than calcium chloride, which is beneficial for administration to the respiratory tract, and citrate, sulfate and lactate ions are safe and acceptable for inclusion in pharmaceutical composition (para 0091). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute one monovalent cation salt for another. One would have been motivated to do so because simple substitution of one known element for another would obtain predictable results as both are art recognized sodium salts for use in respirable dry particle formulations.
6. Claims 48 and 51 are allowed.
CORRESPONDENCE
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615
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