DETAILED ACTION
Claims 10, 14-15, 28-30, 38-40 and 42-43 are currently pending. Claims 10, 14, 28-30 and 38-39 are currently 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 .
Withdrawn Rejections
The rejection of claims 10, 14, 22, 24, 27-30, 35-36, 38-39 and 41 under 112(b) is withdrawn as Applicant has amended to claims to clarify the effects of the HTS and clearly define the administration and composition comprising HTS/capsaicin to HTS treatment.
Examiner’s Note
Applicant's amendments and arguments filed 08/27/2026 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 08/27/2026, it is noted that claims 10 and 30 have been amended. No new matter or claims have been added.
Modified Rejections:
The following rejections are modified based on Applicant’s claim amendments.
Claim Objections
The reply filed on 08/27/2026 is not fully responsive to the prior Office Action because of the following omission(s) or matter(s):
The amendments to the claims do not comply with the Revised Amendment Practice of 37 CFR 1.121 (See OG Notice 23 September 2003). Specifically, a list of all claims should be submitted, the text of withdrawn claims must be included in the listing of the claims and the text of canceled claims must be omitted. Further the claims must have the proper identifiers in parenthetical expression.
Claims 15, 40 and 42-43 are objected as not containing the correct claim identifier. Claims 15, 40 and 42-43 are identified previously presented however should have the claim identifier of withdrawn.
It is noted that 37 CFR 1.121 also states a claim which is previously canceled may be reinstated only by adding the claim as a “new” claim with a new claim number.
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) 10, 14, 28-30 and 38-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over McShane (previously applied) in view of US 2015/0065539 (previously applied).
Regarding claim 10 and 29-30, the limitation of a method of increasing mucociliary clearance in a subject in need thereof comprising administering hypertonic saline (HTS) treatment, wherein the subject has one or more non-cystic fibrosis respiratory diseases, disorder or conditions treatable by increasing ASL layer volume, wherein the subject does not have cystic fibrosis is met by McShane teaches non-cystic fibrosis bronchiectasis (abstract). The goal of airway clearance is to mobilize bronchopulmonary secretion and interrupt the vicious cycle of inflammation and infection. Airway clearance employs an inhaled agent (e.g. 7% hypertonic saline) in conjunction with chest physiotherapy have significant improvements in quality-of-life scores and exercise capacity were achieved in patients using the PEP device twice daily for 3 months (page 650, second column, third paragraph). Nebulized hypertonic saline improved clearance of mucus by reducing osmolality and making it easier to clear (pgs. 651, first column, second paragraph).
Regarding claims 14 and 38-39, the limitation of wherein the one or more non-cystic fibrosis respiratory diseases include bronchiectasis is met by McShane teaching non-cystic fibrosis bronchiectasis (abstract, title).
Regarding claim 28 wherein the HTS treatment has a NaCl concentration of about 1% to 40% w/v is met by McShane teaching nebulized hypertonic saline improved clearance of mucus by reducing osmolality and making it easier to clear (pgs. 651, first column, second paragraph). NIH evidences hypertonic saline is any solution of sodium chloride (NaCl) in water at a concentration of higher than 0.9% w/v (page 1).
McShane does not specifically teach administering an effective amount of one or more neuronal agonists selected from capsaicin (claim 10).
The ‘539 publication teaches increasing mucociliary clearance in a subject. The compounds are effective in increasing the depth of ASL, thereby increasing mucociliary clearance in the subject (abstract). Mucous stasis and increased mucous production are common problems that impact a variety of human conditions. A number of diseases and/or conditions may lead to suboptimal mucous clearance and/or excess mucous production [0002]. The compounds useful include any known activators of cellular mucociliary clearance including capsaicin [0032]. Increasing mucociliary clearance in a subject is taught including administering to a subject an amount of activator compound capable of enhancing the ability of the cellular mucociliary clearance apparatus [0046]. The active agent can be administered as a liquid dosage form or by inhalation via the pulmonary system [0073]. Formulations are taught to include saline solutions [0083]. Hypertonic saltine is taught to be used [0110]. Increased ASL depth is taught (abstract) wherein increasing the depth of ASL would result in volume increase.
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 a combination of HTS and capsaicin to improve mucociliary clearance and ASL layer depth as McShane teaches HTS being used to mobilize bronchopulmonary secretions to treat non-CF bronchiectasis and the ‘539 publication teaches capsaicin being used for mucociliary clearance to treat non-CF diseases and increasing ASL depth. It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a combination of two ingredients, HTS and capsaicin, both known to improve mucous clearance to treat non-CF diseases. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success in using the combination of HTS and capsaicin for inhalation as the ‘539 publication teaches inhalable compositions including capsaicin and saline solutions.
Regarding the limitation of wherein the duration and/or intensity of treatment effects of HTS treatment in the presence of capsaicin is increased in comparison to the duration and/or intensity of treatment effects of HTS treatment when administered without capsaicin is met by the ‘539 publication teaching increasing mucociliary clearance in a subject and ASL layer depth (abstract) thus it would be obvious that the addition of capsaicin, a known mucociliary clearing ingredient, would lead to increased intensity of treatment effects of HTS/capsaicin in comparison to HTS used alone, as adding an ingredient known to increase mucociliary clearance would result in increased mucociliary clearance.
37 CFR 1.132 Declaration
The examiner acknowledges receipt of the Declaration under 37 CFR 1.132 by Julian S. Tam filed on 08/27/2026.
The Declaration under 37 CFR 1.132 filed 08/27/2026 is insufficient to overcome the rejection of claim(s) 10, 14, 28-30 and 38-39 under 35 U.S.C. 103 as being unpatentable over McShane in view of US 2015/0065539 as set forth in the last Office action because:
Applicant has presented data demonstrating the addition of capsaicin to HTS nebulized solution on the change of ASL layer height (volume) in swine trachea in vivo. The addition of capsaicin to HTS significantly prolongs duration of the HTS-triggered increase in ASL layer height and delta ASL height in wild-type swine airways.
In response, the newly presented data is commensurate in scope with the instant claims however is not found to be unexpected. The ‘539 publication teaches increasing mucociliary clearance in a subject. The compounds are effective in increasing the depth of ASL, thereby increasing mucociliary clearance in the subject (abstract). The compounds useful include any known activators of cellular mucociliary clearance including capsaicin [0032]. The active agent can be administered as a liquid dosage form or by inhalation via the pulmonary system [0073]. Formulations are taught to include saline solutions [0083]. Hypertonic saltine is taught to be used [0110]. Increased ASL depth is taught (abstract) wherein increasing the depth of ASL would result in volume increase. Thus the addition of capsaicin to HTS resulting in ASL layer volume increase is not considered unexpected as the ‘539 publication teaches the treatment of capsaicin and HTS to result in increased ASL depth.
In addition to the facts provided above, the examiner notes that the Affiant is the same as the Inventor of the instant application. Therefore, the Affiant has an interest in the outcome of the instant application.
In assessing the weight to be given expert testimony, the examiner may properly consider, among other things, the nature of the fact sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. See Ex parte Simpson, 61 USPQ2d 1009 (BPAI 2001), Cf. Redac Int’l. Ltd. v. Lotus Development Corp., 81 F.3d 1576, 38 USPQ2d 1665 (Fed. Cir. 1996), Paragon Podiatry Lab., Inc. v. KLM Lab., Inc., 948 F.2d 1182, 25 USPQ2d 1561, (Fed. Cir. 1993).
Affidavits or declarations are provided as evidence and must set forth facts, not merely conclusions. In re Pike and Morris, 84 USPQ 235 (CCPA 1949).
Upon consideration of the facts taught by the prior art and the information submitted by the Affiant, the balance of evidence indicates that the prior art teaches the instantly claimed inventions.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues McShane does not specifically teach administering an effective amount of one or more neuronal agonists selected from capsaicin. Applicant has amended independent claims to specify a method of increasing airway surface liquid layer volume.
In response, the ‘539 publication teaches increasing mucociliary clearance in a subject. The compounds are effective in increasing the depth of ASL, thereby increasing mucociliary clearance in the subject (abstract). The compounds useful include any known activators of cellular mucociliary clearance including capsaicin [0032]. The active agent can be administered as a liquid dosage form or by inhalation via the pulmonary system [0073]. Formulations are taught to include saline solutions [0083]. Hypertonic saltine is taught to be used [0110]. Increased ASL depth is taught (abstract) wherein increasing the depth of ASL would result in volume increase. Thus the addition of capsaicin to HTS resulting in ASL layer volume increase is not considered unexpected as the ‘539 publication teaches the treatment of capsaicin and HTS to result in increased ASL depth.
Applicant argues the newly supplied TAM declaration is commensurate in scope with the instant claims. WT airways, adding a neuronal agonist such as capsaicin on its own t HTS treatments enhances duration of the effects of increasing the ASL layer heigh and therefore volume. The duration of ASL layer volume increases.
In response, Applicant is referred to the declaration section above wherein the new TAM declaration is discussed.
Applicant argues McShane in combination with the ‘539 publication would not have been obvious to increase the duration of the ability of HTS to increase the ASL volume for treating non-cystic fibrosis respiratory disease. The cited reference address improvement of mucociliary clearance as an overall phycological outcome but either reference recognizes the HTS included ASL layer volume increase transient response whose duration can be selectively prolonged through capsaicin mediated neuronal signaling. Capsaicin increases the duration of the ASL -volume-increasing effect of HTS compared with HTS administered without capsaicin.
In response, the newly presented data is commensurate in scope with the instant claims however is not found to be unexpected. The ‘539 publication teaches increasing mucociliary clearance in a subject. The compounds are effective in increasing the depth of ASL, thereby increasing mucociliary clearance in the subject (abstract). The compounds useful include any known activators of cellular mucociliary clearance including capsaicin [0032]. The active agent can be administered as a liquid dosage form or by inhalation via the pulmonary system [0073]. Formulations are taught to include saline solutions [0083]. Hypertonic saltine is taught to be used [0110]. Increased ASL depth is taught (abstract) wherein increasing the depth of ASL would result in volume increase. Thus the addition of capsaicin to HTS resulting in ASL layer volume increase is not considered unexpected as the ‘539 publication teaches the treatment of capsaicin and HTS to result in increased ASL depth.
Conclusion
No claims are 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.
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.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613
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