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 .
Election/Restrictions
Applicant’s election without traverse of Group III in the reply filed on 09/24/2026 is acknowledged.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups I and II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/24/2026.
Status of Claims
Claim amendment filed on 09/24/2026 is acknowledged.
Claims 1-10 are withdrawn for being drawn to nonelected groups.
Claims 14 and 15 are new drawn to the method of elected group III.
Claims 11-15 are being examined on the merits herein.
Priority
The instant application 18995122, filed on 01/15/2025, is a 371 of PCT/CN2023/107448, filed on 07/14/2023, which claims foreign priority of China 202210842971.5, filed on 07/18/2022. Certified copy of foreign priority application is provided without English translation.
Information Disclosure Statement
The information disclosure statement (IDS), filed on 01/15/2025, 09/09/2026, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 recites “adding and dissolve”, in which dissolve should be corrected to “dissolving”.
Appropriate correction is required.
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 11-15 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 11 (2) recites “the solution of step (1)”. There is insufficient antecedent basis for this limitation in the claim, because step (1) does not mention or indicate a solution.
Claim 11 (3) recites “filtering, filling and sealing”, it is unclear how and where “filling and sealing” takes place regarding the inhalation solution composition.
Claim 11 recites “wherein, ...nebulizing cup; the nebulizer has ..., and the particles of the 0.9 wt% standard sodium chloride solution”. There is insufficient antecedent basis for this limitation in the claim, because the particles of the 0.9 wt% standard sodium chloride solution was not presented in the previous steps, and it is unclear where the solution comes from and whether this sodium chloride solution is kept in the nebulizer for mixing with the inhalation solution.
Claim 11 recites “the percent deposition of the particles”. There is insufficient antecedent basis for this limitation in the claim because deposition of the particles was not mentioned or defined in the method previously in the claim, and therefore, the percent deposition of the particles lacks antecedent basis.
Claim 11 recites “not less than 50%” without defining a calculation base of the percentage. It is unclear whether the percentage is calculated based upon total particles with all sizes, or it is based on only particles with size of 1.4-5.4 um.
Claim 12 recites “wherein the administration site of the medicament product”. There is insufficient antecedent basis for this limitation in the claim because claim 11, which claim 12 depends upon, does not mention administration site and does not define a medicament product. It is unclear whether “administering ... to a subject” in claim 11 means to be a site, and whether the product refers to the inhalation solution or the inhalation solution in the nebulizing device, because claim 11 does not describe a step of how the inhalation solution being administered.
Claim 13 recites “the medicament product”. Similar to claim that in claim 12, there is insufficient antecedent basis for this limitation in the claim because claim 11, which claim 13 depends upon, does not mention or define a medicament product.
Claim 14 recites “the percent deposition .... not less than 53%; ... not less than 41.5%”. It is unclear whether the percentage is calculated based upon total particles with all sizes, or it is based on only particles with the specific aerodynamic particle size defined in claim.
Claims 14 and 15 recites “preferably”. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 14 and 15 each recites the broad recitations of percent deposition and particle size ranges respectively, and the claim also recites narrower recitations of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the 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 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 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US20200316003, 10/08/2020, IDS of 01/15/2025) in view of Glick (WO2021188564, 09/23/2021, PTO-892).
Zhang throughout the reference teaches a fudosteine pharmaceutical solution preparation for aerosol inhalation (e.g., Abstract, [0002]).
For claim 11: A method of treating a respiratory disease, comprising administering a fudosteine nebulised inhalation solution composition to a subject in need thereof, wherein the fudosteine nebulised inhalation solution composition is prepared by following steps:
Zhang teaches a method preparing pharmaceutical fudosteine solution for aerosol inhalation (e.g., Abstract, [0008]) for treating respiratory system diseases in clinic on patients (e.g., [0004-0005])
adding and dissolving fudosteine or pharmaceutically acceptable salt thereof as an active ingredient into water for injection;
Zhang teaches the preparation method comprising adding water for injection to a liquid formulation device; adding fudosteine, salts thereof and/or hydrates thereof, and stirring until complete dissolution (e.g., Abstract; Claim 9), resulting a fudosteine solution in water.
adding a pH-adjusting agent into the solution of step (1) to adjust the pH of the solution to 3.7-3.9 to obtain an inhalation solution composition;
Zhang teaches adding the pH adjusting agent to adjust pH to obtain the inhalation solution composition (e.g., Abstract; Claim 9) to pH value of 3.5 to 5.5 (e.g., Claim 10), or pH value of 3.5 to 5.0 (Claim 11), overlapping with pH range 3.7-3.9 recited in instant claim.
filtering, filling and sealing the inhalation solution composition;
Zhang teaches that after pH adjustment and further adding rest of total amount of water for injection and mixing, the inhalation solution is filtered via sterile 0.45 um and 0.22 um filter membranes, bottling (corresponding to filling) and encapsulating (corresponding to sealing) the solution in an ampoule, and filling the ampoule with nitrogen gas (e.g., Claim 6).
nebulizing the composition using a nebulizing device;
Zhang teaches using ultrasonic nebulizer to implement the aerosol inhalation administration of the fudosteine pharmaceutical solution to testing animals (Example 2, [0078-0080]).
the nebulizer has a compressor pressure parameter of 1.1-1.6 bar and a spraying rate of 0.4-0.6 ml/min, and the particles of the 0.9 wt% standard sodium chloride solution excited by the nebulizing cup have an average particle diameter of 2.5 -3.5 um;
Zhang teaches administering normal saline (corresponding to 0.9 wt% standard sodium chloride) to animals using the ultrasonic nebulizer for aerosol inhalation (e.g., [0083]).
For claims 12 and 13, Zhang teaches that the aerosol inhalation of fudosteine solution is used for treating sputum thickening, difficulty in expectoration and phlegm obstruction in trachea caused by chronic bronchitis, bronchial asthma and the like, and it is directly inhaled from mouth and nose (e.g., [0007]) for treating respiratory diseases in clinic such as pneumonia, chronic pharyngitis, chronic bronchitis, bronchiectasis, pulmonary abscess, cavitary pulmonary tuberculosis, and the like (e.g., [0004]).
Zhang does not teach the nebulizer features in instant claim 11, or the droplet particle sizes during nebulization inhalation as recited in instant claims 11 and 14-15.
Glick throughout the reference teaches compounds, including pharmaceutically acceptable API (active pharmaceutical ingredient) niclosamide (Pg. 18, Lines 25-26) and fudosteine (Pg. 79, line 4), and compositions with particular particle size (e.g., a particular particle size distribution and/or a particular particle size range and/or a specific surface area range), and methods of treating coronavirus infections in dosage forms suitable for respiratory administration via inhalation and/or intranasally (e.g., Abstract).
Glick teaches inhalation devices can be ultrasonic nebulizers, jet nebulizers, and the latter generally utilize compressors to generate compressed air, which breaks the liquid medication into small breathable droplets, which form an aerosolized mist (Pg. 108, Lines 22-25); some nebulizers provide aerosol by a breath enhanced mode such as PART LC Sprint from PARI Starnberg (Pg. 109, Line 1). As evidenced by instant specification [0091], which has nebulizing cup with pressure of 1.2 bar, spraying rate of 0.6 ml/min, corresponding to instant claim 11.
Furthermore, the nebulizer having a nebulizing cup, compressor, compressor pressure parameter, and the average particle diameter generated from standard sodium chloride, they are interpreted as the properties, process of using, or intended use of the nebulizer, which has been taught by the prior art, therefore, the properties would necessarily present or would be capable of being achieved in prior art. Especially, choosing a suitable nebulizer available in the market for inhalation is a routine practice for inhalation compositions, differences in nebulizer models will not support the patentability of subject matter encompassed by the prior art.
Glick teaches the particle size distribution D(0.9) (same as D90) is from about 6.0 to 8.0 um (e.g., Pg. 197, Claim 44; Pg. 198, Claim 54), D(0.5) (same as D50) from about 1.0 to about 4.0 um (e.g., Pg. 197, Claim 50; Pg. 198, Claim 54), or from about 2.5 to 3.5 um (e.g., Pg. 197, Claim 52); D10 from about 0.3 to 0.9 um (e.g., Pg. 197, Claim 48; Pg. 198, Claim 54), or about 0.1 to 1.0 um (e.g., Pg. 197, Claim 47), overlapping with particle sizes in instant claim 11. Glick teaches that the compositions, e.g., brittle matrix particle compositions, can produce an FPF (as fine particle fraction) value of over 50% (e.g., over 55%, over 60%, over 65%, or over 70%) (Pg. 116, Lines 12-13), which are effective for deposition, penetration, or retention of the composition primarily in the peripheral lung regions, including the bronchioles and alveoli (Pg. 114, Lines 26-28). Based on the context, with D50 from about 1.0 to about 4.0 um, the fine particle fraction over 50% corresponds to the percent deposition of the particles with aerodynamic particle size D50. Further, Glick demonstrates that the systemic and respiratory efficacy, safety, and tolerability inhalation composition, which can comprise fudosteine with niclosamide, exhibiting a total emitted dose of greater than 85% (e.g., Pg. 200, Claim 68), corresponding to deposition percent as well. Glick teaches the particles having an aerodynamic diameter of between 2-5 um (e.g., Pg. 115, line 4; Pg. 120, Lines 17-18; Pg. 122, line 6; Claim 76), all the values overlap with those present in instant claims 11 and 14-15.
Further regarding claim 11 limitation of “ the inhalation solution during nebulization inhalation has following droplet particle sizes: D90 particle size of 7.0-10.0 um, D50 particle size of 2.8-4.5 um, and D10 particle size of 0.5-1.5 um, and the percent deposition of the particles with aerodynamic particle size of 1.4 -5.4 um in the fudosteine inhalation solution is not less than 50%” , it is interpreted as intended use or process of using of the inhalation solution during nebulization, because there is no specific structural step in instant claim showing that during the inhalation there is specific control regarding particle size from the nebulizer. Therefore, when the composition solution is prepared the same way in prior art as instantly claimed, choosing a nebulizer that is known and available in the market, will be capable of generating the droplet sizes as instantly claimed during nebulization inhalation.
Further regarding claims 14-15, the limitations led by “preferably” are not considered required. As discussed above, preferably is a narrower limitation in the same claim while a broader limitation is present, therefore, the feature introduced by such word is considered merely exemplary, not requirement.
It would have been prima facie obvious for a person with ordinary skills in the art prior to filing date to incorporate the teaching from Glick of the nebulizer and particle sizes into the inhalation composition preparation method of Zhang to arrive at current invention. Because both teach method for inhalation compositions, especially Glick demonstrates that the systemic and respiratory efficacy, safety, and tolerability inhalation composition, which can comprise fudosteine with niclosamide, exhibiting a total emitted dose of greater than 85% (e.g., Pg. 200, Claim 68) with aerodynamic diameter of between 2-5 um (e.g., Pg. 201, Claim 76) via inhalation (e.g., to the lungs)(e.g., Pg. 201, Claim 77) through a pressurized metered dose inhaler (e.g., Pg. 202, Claim 85), it would have motivated artisans to implement the nebulizers generating similar particle sizes for reasonable expectation of success. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the particle sizes and percent deposition of particles overlap with those in prior art. Furthermore, as discussed above, there is no specific structural step in instant claim showing that during the inhalation there is specific control regarding particle size from the nebulizer. Therefore, when the composition solution is prepared the same way in prior art as instantly claimed, choosing a nebulizer that is known and available in the market, which is taught by Glick, will be capable of generating the droplet sizes as instantly claimed during nebulization inhalation.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONGXIU ZHANG SPIERING whose telephone number is (703)756-4796. The examiner can normally be reached 7:30am-5:00pm (Except for Fridays).
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
