DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicant’s Request for Continued Examination (RCE), Amendments and Remarks, filed 17 February 2026, in the matter of Application N° 18/260,222. Said documents have been entered on the record. The Examiner further acknowledges the following:
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 8, 2025 has been entered.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
No claims have been added or canceled.
Claims 1, 11, and 13 have been amended. Claims 1 and 13 have been amended to reflect that the aqueous solution composition is “hypertonic to mucosa”. Of particular note is that the compositional merits of the spray at issue in either claim has not changed. Claim 13 is additionally amended to remove the term “prophylactically”. Claim 11 has been amended to remove “pump” and replace it with “nasal.”
No new matter has been added.
Thus, claims 1-5, 7-18, and 20-22 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statement(s) (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 112
Applicant’s amendment to claim 11 removing the term “pump” is persuasive in overcoming the previously raised new matter rejection. Said rejection is withdrawn.
Applicant’s amendment to claim 13 removing the term “prophylactically” is persuasive in overcoming the previously raised enablement rejection. Said rejection is withdrawn.
Rejection under 35 USC 103
Applicant’s remarks addressing the Liang reference are considered persuasive in overcoming the previously maintained rejection over Liang, Shapiro, and AFP. Specifically, noting that Liang appears to produce only isotonic solutions, the Examiner agrees that there would be no need to modify the practiced composition with the teachings of Shapiro. Said rejection is withdrawn.
It is noted that in view of this withdrawal, the filed response is further considered to affirm the Examiner’s position that Shapiro discloses the recited hypertonic property on its own.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 17 October 2025 since the art that was previously cited continues to read on the amended and previously recited limitations.
Claim Rejections - 35 USC §102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 10-13, 17, 18, 21, and 22 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hansen (USPN 6,696,041 B2; IDS reference).
The limitations of amended claim 1 recite a nasal spray composition comprising an aqueous solution comprising a microbial agent at an effective concentration to limit a microbial infection, wherein the aqueous solution is a hypertonic solution, wherein the hypertonic solution is at least 2% (w/v) salt.
Hansen discloses a nasal spray solution comprising an aqueous solution comprising up to 160,000 ppm sodium iodide, up to 75,000 ppm of sodium chloride, and up to 50,000 ppm iodine.
Parts per million (ppm) converts to weight percent by simply dividing by 10,000:
(‘x’ ppm)([1 mg/mL]/1,000 ppm)(0.1 wt%/[1 mg/mL]) = ‘x’ wt%
The foregoing composition is thus considered to disclose comprising up to 16 wt% sodium iodide, up to 7.5 wt% sodium chloride, and up to 5 wt% iodine (see e.g., claim 1).
Hansen further defines the iodine as being in the form of povidone-iodine (see e.g., col. 3, lines 51-60; Examples 1 and 2).
The pH of the practiced composition is disclosed as ranging from about 5.5 to about 8.5, preferably from about 6-8, and more preferably from about 6.5-7.5 (see e.g., col. 3, lines 42-50).
The reference is additionally considered to disclose the use of a “pump” sprayer (see e.g., Example 1, col. 5, lines 1-2).
The Abstract discloses that iodine is a broad-spectrum microbicide which is administered via a nasal spray to humans.
The reference is therefore considered to teach every limitation of the recited composition and method.
Response to Arguments
Applicant’s arguments with regard to the rejection of claims 1-4, 7, 10-13, 17, 18, 21, and 22 under pre-AIA 35 USC 102(a)(1)/(a)(2) as being anticipated by Hansen have been fully considered, but are not persuasive.
Applicant argues that while Hansen discloses the recited composition, “fails to teach or make obvious ‘wherein the aqueous solution is hypertonic to mucosa with at least 2% (w/v) salt’” and that “Hansen fails to teach or make obvious the tonicity of the solution.”
The Examiner disagrees.
Having considered the amendment to claims 1 and 13 with respect to the tonicity, the Examiner submits that the current language of the claim is confusing. The language “wherein the aqueous solution is hypertonic to mucosa with at least 2% (w/v) salt” makes it somewhat unclear as to whether the 2% salt is found within the mucosa tissue or within the claimed solution. For the purposes of continued consideration on the merits, the Examiner will continue to interpret the salt percentage as being a limitation of the composition.
That being said, Applicant’s amendment to the tonicity of the solution whereby it is hypertonic with respect to the mucosal tissue to which it is delivered is not persuasive. The composition of claim 1 remains anticipated by Hansen as it discloses a nasally administered solution that meets the generically recited compositional merits.
That it is hypertonic with respect to the tissue to which it is delivered in no way changes the metes and bounds of the composition itself; the solution being “hypertonic” remains defined by the compositional merits presented in the claims.
Thus, for this reason, Applicant’s response is unpersuasive and the rejection is maintained.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-5, 7-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Shapiro et al. (WO 2011/094504 A2).
The limitations of claims 1-5, 7, 10-13, 17, 18, 21, and 22 are previously discussed. Claims 8 and 9 recite that the aqueous solution further comprises a buffer (e.g., sodium bicarbonate). Claims 14-16 recite that the method of treating further comprises cleaning the nasal cavity by employing such steps as blowing the nose, flushing (irrigating) the nose, and introducing a decongestant.
Shapiro discloses a single-use irrigation device comprising an antimicrobial agent, a decongestant, and a buffered hypertonic solution having a pH between about 4 and about 9 (see e.g., claims 8, 14, and 18). Claim 13 discloses that the antimicrobial agent is present in a concentration ranging from about 0.1% to about 30% of the composition.
Paragraph [0063] further defines the antimicrobial agent and that said definition is inclusive of povidone-iodine.
Paragraph [0073] further defines the pH-adjusting buffer as including compounds such as sodium bicarbonate. Therein, the buffers are used to adjust the pH to 6.5 or less than 6.5.
With regard to the above disclosure that a hypertonic aqueous solution is produced, ¶[0071] discloses that suitable ionic tonicity agents such as sodium chloride are used.
Claims 18 and 19 discloses methods of treating a patient using the foregoing disclosed device-contained formulations, for the condition of sinusitis, which per ¶[0003] and ¶[0004] is defined as being a condition that results from bacterial infection of the sinuses.
Based on the teachings of Shapiro, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed compositions and arriving at the recited method of treatment a microbial infection. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Claims 1-5, 7-18, and 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Hansen (USPN 6,696,041 B2; IDS reference) in view of Shapiro et al. (WO 2011/094504 A2) and American Family Physician (herein referred to as “AFP”; 2000).
The limitations of claims 1-4, 7, 10-13, 17, 18, 21, and 22 are discussed above.
The limitations of claim 5 recites that PVP-I is present in an amount of about 2.3%. Claims 8 and 20 recite that the composition further comprises a buffer, with claim 9 narrowing the buffer to sodium bicarbonate. The limitations of claims 14-16 add to the method of treatment, an additional step of clearing the nasal cavity (e.g., blowing the nose) before administering the composition, and that said composition further comprises a decongestant.
The teachings of Hansen are presented above.
Regarding claim 5, the reference discloses that the composition will contain up to 16 wt% sodium iodide and up to 5 wt% of iodine. The reference also discloses that the iodine will be defined as povidone-iodine (PVP-I). However, it does not expressly disclose an amount of about 2.3 wt% PVP-I.
MPEP §2144.05(I) states that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” The Examiner submits that the recited limitation is well encompassed by Hansen, thereby rendering it prima facie obvious, absent a clear showing of evidence to the contrary.
Hansen’s disclosure pertaining to the pH of the administered composition is also disclosed. However, the use of buffers or pH adjusters to arrive at the desired pH, while taught is not expressly so. Nevertheless, Hansen does teach and suggest their use for adjusting the composition to the desired pH. Sodium bicarbonate is not expressly mentioned.
The teachings of Shapiro are presented above and are considered to remediate this deficiency, specifically disclosing sodium bicarbonate as a salt buffer compound that is used to achieve a pH consistent with the instantly claimed invention. See e.g., ¶[0073].
Hansen is additionally deficient with respect to the steps recited by instant claims 14-16.
AFP is considered to remedy the deficiency as it pertains to claims 14 and 15. Therein, AFP is specifically directed to the correct use of nasal sprays (see Title). The article categorizes nasal sprays as being either in pressurized form or pump bottles. Regardless of their categorization, application of nasal sprays is preceded by a step where the user first blows their nose in order to clear it of mucus.
AFP does not provide any disclosure of specific formulations that are applied or disclose any method of specifically treating a microbial infection. Instead, it is relied upon for its showing that the ordinarily skilled user of such a spray would quite commonly remove the naturally-occurring mucus barrier in the nasal cavity ahead of spraying an infection-treating formulation into the nasal cavity. With the mucus barrier removed, the chance of the applied formulation to be absorbed into the nasal cavity tissue is maximized.
Lastly, with respect to claim 16, Hansen does not disclose administering a decongestant with the practiced PVP-I formulation, although it does teach co-administering a steroid such as fluticasone or budesonide.
Shapiro is relied upon here again to provide motivation for conducting the instantly claimed step. As discussed above, Shapiro discloses broader combinations for the active agents that are administered to the nose; teaching, for instance, that an antimicrobial agent may be further combined with a steroid or a decongestant (vasoconstrictor) (see e.g., claims 7, 14, 18, and 21).
The Examiner acknowledges that Hansen focuses specifically on administering combinations of iodine. However, in view of the combined teachings of the reference, the ordinarily skilled artisan would observe the teachings of Shapiro as a broader disclosure supporting the position that different combinations of actives may be employed in treating infections of the nasal cavities. This common goal is shared by both references and is thus considered to provide the artisan with the requisite motivation to further combine Hansen’s composition with a decongestant active agent as disclosed by Shapiro. See MPEP §2144.06(I) which states that “[i]t 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.”
Based on the foregoing teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition and arriving at the recited method of treatment. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicant’s arguments with regard to the rejection of claims 1-5, 7-18, and 20-22 under 35 USC 103(a) as being unpatentable over the teachings of Shapiro et al. alone; and Hansen et al. in combination with Shapiro et al. and AFP, have been fully considered, but they are not persuasive.
Applicant’s remarks again reiterate the amendments made to claims 1 and 13 with respect to the claimed composition being “hypertonic to mucosa with at least 2% (w/v) salt.”
As discussed above, the Examiner indicates that the broadest reasonable interpretation of the amendment is such that the composition, styled as being “hypertonic” remains defined by the merits of its constituency, namely that it is an aqueous solution whose salt concentration is greater than 2% (w/v).
The disclosure of Shapiro continues to meet this limitation as well as the “hypertonic” property of the composition. Apart from disclosing outright that the administered solution may be a hypertonic solution, the Examiner again acknowledges that the solution contains amounts of sodium chloride that are less than the claimed 2% (w/v). However, as discussed during the telephone interview of 27 January 2026, the Examiner pointed out that salt compounds are employed in amounts that provide a cumulative salt concentration that exceeds the 2% minimum. Furthermore, salt limitations as set forth in instant claim 7, for instance, do not exclude other salts from being present in the composition and contributing to that percentage.
As such, Applicant’s amendments and remarks traversing Shapiro alone, remain unpersuasive. The rejection over Shapiro is maintained.
Applicant’s remarks directed to the combination of Hansen and Shapiro echo the assertions provided with respect to the above-maintained anticipation rejection.
Regarding Hansen, Applicant presents from the reference that “these ionic species will react chemically with organic or biological chemicals on or in the virus so as to kill it or render it ineffective.” Regarding Shapiro, it is again argued that the reference teaches “tonicity agents to approximate the osmotic pressure of normal lachrymal fluids, with is equivalent to 0.9% solution of sodium chloride”.
Applicants conclude from these statements that “Hansen in view of Shapiro would be unsatisfactory for its intended use because Hansen utilizes the ionic species as an antimicrobial agent not a tonicity agent as in Shapiro.”
The Examiner, in response, respectfully submits that Applicant’s amendments and remarks do not change the compositional disclosures of the references. Applicant’s amendments to claims 1 and 13 simply reword the claim to indicate that the claimed solution is hypertonic with respect to its intended target and do not change the composition at issue.
As such, both Hansen and Shapiro continue to meet the recited limitations as discussed above.
The Examiner finds Applicant’s response unpersuasive; said rejections are therefore maintained.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 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.
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 or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615