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 .
The amendments filed on 03/29/26 have been received and entered. The text of those sections of Title 35, U.S. Code, not included in this action can be found in a prior Office action. Any rejections set forth in a previous Office action that is not specifically set forth below is withdrawn.
Claims 1, 3, 6-11,13, 15-19 are pending.
Withdrawal of Rejection(s)
The rejection of claims 2 and 4 under 35 U.S.C. 102(a)(1) as being anticipated by Ying (CN 109419785 A – English Translation) is withdrawn based on the amendment to cancel the claims.
The rejection of claims 2, 4, 5, and 12 under 35 U.S.C. 103 as being unpatentable over Ying (CN 109419785 A – English Translation) in further view of Huaran (CN 104207146 A – English Translation) is withdrawn based on the amendment to cancel the claims.
The rejection of claim(s) 1-19 under 35 U.S.C. 103 as being unpatentable over Ying (CN 109419785 A- English Translation) in view of Huanran (CN 104207146 A-English Translation), and further in view of Chyou-wei Wei (2009,1297-1306). Chyou-wei Wei (2009,1297-1306) is withdrawn based on the Editorial Expression of Concern of the Wei article.
Pending Rejection(s)
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 1, 3, and 6-9 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.
In claim 1, the amended claim recites the respiratory disease is consisting of chronic obstructive pulmonary disease (COPD), asthma, lung fibrosis, cystic fibrosis and acute respiratory distress syndrome (ARDS). It is unclear if the respiratory disease encompasses all the diseases. As currently written the respiratory disease consists of all the conditions. Suggest, “…the respiratory disease is selected from the group consisting of ….”. Clarification is requested.
Claims dependent on rejected claim 1 are rejected for failing to cure the indefiniteness.
Claim Rejections - 35 USC § 102
Claims 1, 3,and 6-9 are rejected under 35 U.S.C 102 as being anticipated by Ying (CN109419785A-English Translation), for the reasons set forth in the previous office action, and for the following reasons below.
Response to Arguments
Applicant’s arguments filed 03/29/2026 have been fully considered but they are not persuasive. Applicant argues:
Ying fails to disclose, either expressly or inherently the methods for treating specific lower respiratory tract diseases. Amended claim 1 is directed to methods for treating respiratory disease, wherein the respiratory disease is consisting of chronic obstructive pulmonary disease (COPD), asthma, lung fibrosis, cystic fibrosis and acute respiratory distress syndrome (ARDS) and wherein the particle size of the aerosol ranges from 10 nm to 100 um.
Ying teaches a method of application of the H. Cordata extract preparation in preparing an aerosol for treating respiratory tract inflammation wherein the agent treats pharyngitis, upper respiratory tract infection or bronchitis. Acute respiratory distress syndrome (ARDS) can develop from upper respiratory infections and as such, treating one can prevent the other.
Ying does disclose such a method of treatment for treating upper respiratory infections with H.Cordata extract, a person with ordinary skill in the art would know that when treating a respiratory infection not only can acute respiratory distress syndrome develop, but many symptoms of upper respiratory disease overlap with asthma including coughing and shortness of breath, and in some severe cases one can develop asthma from an upper respiratory infection. Therefore, Ying’s method of treatment is still effective and can be applied to the present invention.
Applicant further argues Ying does not disclose claimed particle size range. Ying only discloses the size of the mist ranging from 1-10µm, whereas the present invention recites a particle size ranging from 10nm to 100µm.
Ying discloses the single dose is 2-10 mL/60 kg body weight, and the droplet diameter formed is 1-10µm. The range 1-10µm is fully contained within 10nm to 100µm, 10nm is equal to 0.01µm, 1µm is greater than 0.01µm and 10µm is less than 100µm, the entire 1-10µm fits within the 10nm-100µm range.
Claim Rejections - 35 USC § 103
Claims 1, 3, and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Ying in view of Huanran (CN104207146A) for the reasons set forth in the previous office action, and for the following reasons below.
Response to arguments:
Applicant argues that the particle size is not arbitrary, but is critical for enabling efficient depositions of therapeutic aerosol across different regions of the targeted respiratory tract, aerosols smaller than 1µm are capable of traveling into different regions, particles of 1-10µm deposit differently.
In view of this the claimed particle size range enables controlled and differential deposition of therapeutic aerosol throughout the respiratory tract. As explained above, the claimed range 1-10µm directly fits within the present inventions range of 10nm-100µm. 10nm is equal to 0.01µm, 1µm is greater than 0.01µm and 10µm is less than 100µm. Under applicant’s ranges, and the present argument, applicants ranges would also include aerosol sizes that travel deeply into alveolar regions and primarily deposit in bronchi and bronchioles as their ranges include a range smaller than 100µm which would include ranges between 1-10µm. Ying does not expressly teach that the 1-10µm particle size range is delivered into the deep lung regions such as the alveolar regions, however, it has been shown in the art that 1-5µm is considered as the best size range for particle deposition in the alveolar region as cited by (Birenda (Pharmaceutics. 2020 Dec 28;13(1):31), (Kanig J.L. Pharmaceutical Aerosols. J. Pharm. Sci. 1963;52:513–535. doi: 10.1002/jps.2600520603.), and( Bosquillon C., Lombry C., Preat V., Vanbever R. Comparison of particle sizing techniques in the case of inhalation dry powders. J. Pharm. Sci. 2001;90:2032–2041. doi: 10.1002/jps.1154) (see entire document for all).
Furthermore, applicant argues Huanran is directed to oral nutritional compositions and does not teach or suggest aerosol delivery, particle size control, or pulmonary deposition behavior. One would interpret an oral delivery of a composition as an equal method of delivery as an aerosol delivery where liquid or powder particles are suspended into a gas like product and delivered into the mouth. In the case of Huanran, it is taught that the invention can made into a drink and it will be spray-dried or made into less black sesame powder (see embodiment 1).
Allowable Subject Matter
Claims 11,13, and 15-19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims allowed
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARNITIA T WALKER whose telephone number is (571)272-2550. The examiner can normally be reached Monday-Friday 8:00am-5:00pm.
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/Marnitia T Walker/
Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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