DETAILED ACTION
Claims 25-27, 29-30, 32, 34-36 and 41-44 are currently pending and under examination.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/06/2026 has been entered.
Information Disclosure Statement
Applicant’s Informational Disclosure Statement, filed on 11/18/2025, 01/06/2026, 04/13/2026 has been considered. Please refer to Applicant's copy of the 1449 submitted herein.
Withdrawn Rejections
The prior rejection of claims 31-36 under 112(b) is withdrawn in light of Applicant’s claim amendment to specify the amounts claimed are directed to daily dose of the composition to be administered, which the Examiner finds persuasive.
Examiner’s Note
Applicant's amendments and arguments filed 01/06/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 01/06/2026, it is noted that claims 1, 32 and 34-36 have been amended and no new matter or claims have been added.
New Rejections:
The following rejections are newly applied based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 112 (b)
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 35-36 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 35-36 are dependent on claim 33, a canceled claim. The scope of claims 35-36 cannot be determined as dependency on a canceled claim leads to unclear metes and bounds. For examination purposes claims 35-36 will be deemed to be dependent on claim 29, as was corrected in claim 34 of the instant claims.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
Claim Rejections - 35 USC § 103
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.
Claim(s) 25-27, 29-30, 32, 34-36 and 41-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 111297838 (previously applied) and CN 111110634 (previously applied).
Regarding claims 25 and 29, the limitation of a pharmaceutical composition, comprising chloroquine at 1 to 200 mg/mL and a solvent, wherein the solvent is propylene glycol and wherein the pharmaceutical composition is thermally aerosolized and wherein the composition is suitable for use in the treatment or prevention of a viral lung inflation and suitable to be administered by inhalation is met by the ‘838 publication teaches inhalation spray of antivirus medicines (title) wherein hydroxychloroquine is well known to effectively treat a new coronavirus pneumonia (page 1, last paragraph). The active agent is present at 10 mg/mL, 50 mg/mL and 100 mg/mL (page 4). The solvent includes at least one of water, polyethylene glycol and propylene glycol (page 6), thus teaching the combination of water and propylene glycol. Embodiment 1 contains propylene glycol hydroxychloroquine sulfate and water for a concentration of 20 mg/ml (Embodiment 1). The composition is taught to be heat atomized (page 6), and thus is capable of thermal aerosolization. The ‘838 publication teaches the polar solvent increase the solubility of the antiviral drugs and that proportion of water and propylene glycol can be adjusted and the aim of completely dissolving the medicine is fulfilled (page 6, para 3).
Regarding claims 26-27, the limitations of chloroquine or salt is present in a range of from 1 to 50 mg/mL, 10 to 45 mg/mL is met by the ‘838 publication teaching 20 mg/ml (embodiment 1).
Regarding claim 30, the limitation of wherein the viral lung infection is caused by betacoronovirus is met by the ‘838 publication teaching treatment of COVID-19 (page 5, Embodiment 1), wherein the instant specification teaches betacoronavirus to include COVID 19 (instant specification page 7, lines 28-35).
Regarding claim 30, 32, 34-36, the limitations of suitable to be administered as a daily dose, the daily dose comprising 0.001 to 20 mg, selected from loading, maintenance or a combo dose are intended use limitations. The ‘838 publication teaches a composition comprising chloroquine at 20g or 20mg/ml (Embodiment 1) and thus is capable of being administered at the daily and maintenance dose.
Regarding claim 41, the limitation of comprised in a liquid aerosol is met by the ‘838 publication teaching liquid aerosol (page 4, last paragraph).
Regarding claims 43-44, the limitation of configured for administration to a mammalian or avian subject is met by the ‘838 publication teaching administration to persons (page 5) and the ‘838 publication teaching treatment of COVID-19 (page 5, Embodiment 1). Thus is capable of the intended use of administration of mammalian or avian subject, specifically human at risk of having COVID-19.
The ‘838 publication does not specifically teach wherein the liquid aerosol has a Mass Median Aerodynamic Diameter in a range of from 1 to 5 um is met by the ‘634 publication teaching
The ‘634 publication teaches chloroquinine phosphate inhalation aerosol (title). Chloroquine phosphate inhaler may be the first small molecule for administration for the treatment of coronavirus (page 1, second paragraph). Aerosols can allow drug particle to directly enter the lungs and are in the form of a fine mist (page 2, paragraphs 3-4). The particle size of the active ingredient is taught to be D10 less than 2um, D50 less than 4 um and D90 less than 6 um (page 3, 6th paragraph, page 4, first paragraph). The composition is taught to include chloroquine phosphate and water (page 4).
Given the disclosure of each component individually it would have been prima facie obvious for a person having ordinary skill in the art at the time of filing to have selected and combined known components for their established functions with the predictable results by following the teaching of the ‘838 publication. MPEP 2143 and 2144.06(I). Additionally, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have formulated a composition comprising water and propylene glycol within the instantly claimed amounts through routine optimization. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. One of ordinary skill in the art would have been motivated and had an expectation of success in optimizing the ratio of water and propylene glycol because the ‘838 publication discloses that the solubility of the active agent can be adjusted by varying the proportion of water to propylene glycol.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use known particle size of chloroquine taught to be administered for inhalation as taught by the ‘634 publication for the chloroquine composition being administered by inhalation as taught by the ‘838 publication. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘634 publication and the ‘838 publication are both directed to chloroquine inhalable compositions being administered to the lungs to treat coronavirus. One or ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘634 publication teaches method of obtained the desired particles size through micronization of the active drug (embodiment 2).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 25-27, 29-30,32, 34-36 and 41-44 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 25-27 and 29-44 of copending Application No. 18/044,217 (reference application) in view of CN111297838 (previously applied). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims and the ‘217 publication are directed to compositions containing chloroquine (or specifically hydroxychloroquine) and propylene glycol in overlapping concentrations which are suitable for thermal aerosolization for the treatment of viruses such as COVID-19 and provided in metered dosage forms, thus teaching the limitations of the instant claims.
The ‘838 publication teaches inhalation spray of antivirus medicines (title) wherein hydroxychloroquine is well known to effectively treat a new coronavirus pneumonia (page 1, last paragraph) and teaches chloroquine and hydroxychloroquine (page 4, third paragraph). The active agent is present at 10 mg/mL, 50 mg/mL and 100 mg/mL (page 4). The solvent includes at least one of water, polyethylene glycol and propylene glycol (page 6), thus teaching the combination of water and propylene glycol. Embodiment 1 contains propylene glycol hydroxychloroquine sulfate and water for a concentration of 20 mg/ml (Embodiment 1). The composition is taught to be heat atomized (page 6), and thus is capable of thermal aerosolization. The ‘838 publication teaches the polar solvent increase the solubility of the antiviral drugs and that proportion of water and propylene glycol can be adjusted and the aim of completely dissolving the medicine is fulfilled (page 6, para 3).
It would have been prima facie obvious to one of ordinary skill in the art to use either chloroquine and hydroxychloroquine in the composition taught by the ‘217 application because the ‘838 publication teaches the use of either chloroquine or hydroxychloroquine in a composition comprising water and propylene glycol and the ‘217 publication teaches a composition including hydroxychloroquine in water and propylene glycol, thus rendering it obvious to use specifically chloroquine in place of hydroxychloroquine.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘838 publication does not disclose a solvent system as claimed but relates to chloroquine phosphate in water (Examples 3-4). Examples 19-20 are directed to chloroquine sulphate in propylene glycol. Exemplified compositions do not use a combination of water and propylene glycol and fails to suggest propylene glycol in a mount of at least 65% of the solvent.
In response, the ‘838 publication teaches the polar solvent increase the solubility of the antiviral drugs and that proportion of water and propylene glycol can be adjusted and the aim of completely dissolving the medicine is fulfilled (page 11, para 4). Given the disclosure of each component individually it would have been prima facie obvious for a person having ordinary skill in the art at the time of filing to have selected and combined known components for their established functions with the predictable results by following the teaching of the ‘838 publication. MPEP 2143 and 2144.06(I). Additionally, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have formulated a composition comprising water and propylene glycol within the instantly claimed amounts through routine optimization. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. One of ordinary skill in the art would have been motivated and had an expectation of success in optimizing the ratio of water and propylene glycol because the ‘838 publication discloses that the solubility of the active agent can be adjusted by varying the proportion of water to propylene glycol.
Applicant argues by providing a specific combination and ratio of the solvent, the solubility and/or stability of chloroquine or pharmecuatially acceptable salt thereof may be improved (instant specification page 6). Applicant argues the skilled artisan is given no teaching or guidance form the ‘838 publication to arrive at the present solution, namely that the use of a solvent comprising a combination of at least 85% propylene glycol and water would result in an unexpected high solubility for number of inhalation necessary to deliver an effective dose of chloroquine or a pharmaceutically acceptable salt thereof to the lung.
In response it appears Applicant is arguing unexpected results. Attorney’s arguments cannot take the place of factual evidence when factual evidence is required. The portion of the instant specification pointed by Applicant does not contain factual data. Further, the ‘838 publication teaches the polar solvent increase the solubility of the antiviral drugs and that proportion of water and propylene glycol can be adjusted and the aim of completely dissolving the medicine is fulfilled (page 6, para 3). Thus, the using propylene glycol to dissolve is not unexpected.
Applicant argues the ‘634 publication is silent with regard to the solvent and therefore cannot cure the deficiencies of the ‘838 publication.
In response, Applicant’s arguments regarding the ‘838 publication are addressed above as first presented.
Applicant argues the copending claims are directed to hydroxychloroquine and not chloroquine and thus are different.
In response, the ‘217 publication are directed to compositions containing chloroquine (or specifically hydroxychloroquine) and propylene glycol in overlapping concentrations which are suitable for thermal aerosolization for the treatment of viruses such as COVID-19 and provided in metered dosage forms. Thus the disclosure of hydroxychloroquine falls within the instant claims chloroquine, as a specific chloroquine. Additionally, the ‘838 publication teaches both chloroquine and hydroxychloroquine.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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, Brian-Yong Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
Prosecution Insights