DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 22 May 2026, in the matter of Application N° 18/260,222. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 2-4 and 17 have been canceled. Claims 23-27 are newly added and are supported by the originally-filed disclosure (e.g., claims).
Claims 1, 5, 8, 9, 13, 18, and 20 have been amended. Independent claims 1 and 13 have been amended with the limitations of the canceled claims. The remaining dependent claims have been amended to account for these changes (i.e., narrowing the buffer to sodium bicarbonate, changing claim dependencies, etc.). No new matter has been added.
Thus, claims 1, 5, 7-16, 18, and 20-27 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 102
Applicants’ amendments to independent claims 1 and 13 are persuasive in overcoming the previously maintained anticipation rejection. Specifically, the addition of the buffer component to each claim, previously recited in claim 8 (now canceled), and unrejected over the reference, is adequate in overcoming the rejection. Said rejection is withdrawn.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 26 February since the art that was previously cited continues to read on the amended and newly recited limitations.
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, 7-16, 18, and 20-27 are rejected under 35 U.S.C. 103 as being unpatentable over Shapiro et al. (WO 2011/094504 A2). [emphasis added to reflect added/canceled claims]
As amended, the limitations of claim 1 recite a nasal spray composition comprising an aqueous solution comprising a 1.5% to 3.0% (w/v) of povidone-iodine (PVP-I) as a microbicidal agent at an effective concentration to limit a microbial infection and a buffer present in an amount of at least 0.2% (w/v), wherein the aqueous solution is a hypertonic solution, wherein the hypertonic solution is at least 2% (w/v) salt.
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 [0064] discloses that the antimicrobial agent is more [most] preferably from about 0.01% (w/v) to about 3% (w/v), and that any concentration value between these endpoints is also contemplated.
Paragraph [0073] further defines the pH-adjusting buffer as including compounds such as sodium bicarbonate and that preferably, the amount of buffer present is within the range of 0.1-1.5 percent. 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.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 5, 7-16, 18, and 20-27 under 35 USC 103(a) as being unpatentable over the combined teachings of Shapiro et al. have been fully considered, but they are not persuasive.
Applicants’ prevailing traversal against the rejection is on the grounds that “[t]hough Shapiro discloses vast ranges and options, Shapiro only discloses the preferable antimicrobial agent, levofloxacin” and that “Shapiro further does not connect the desired antimicrobial agent to the desired range to motivate one of ordinary skill in the art to select 1.5% (w/v) to 3% (w/v) of povidone iodine.”
The Examiner, in response, respectfully disagrees with Applicants’ position and maintains the rejection for the reasons already of record. Pursuant to the above assertion, the Examiner additionally directs Applicants to MPEP §2123(I) and (II) which respectively state that “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” and “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments … ‘[a] known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use’”.
In the instant case, Shapiro discloses the generic antimicrobial nasal spray that is buffered and pH-adjusted as instantly claimed. The claims additionally provide broader disclosure for the antimicrobial agent that may be formulated into the practiced spray. Thus, while the Examiner agrees with Applicants that the reference specifies and exemplifies levofloxacin as a preferred agent, it remains that the reference presents alternative antimicrobial agents that may be used and discloses overall, that said agents are preferably used in amounts that read on and overlap with the recited range of 1.5% to 3.0% (w/v) of the nasal spray.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
Claims 1, 5, 7-16, 18, and 20-27 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). [emphasis added to reflect added/cancelled claims]
The limitations of the amended claims 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 previously presented.
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, 7-16, 18, and 20-27 under 35 USC 103(a) as being unpatentable over the teachings of Hansen et al. in combination with Shapiro et al. and AFP, have been fully considered, but they are not persuasive.
Applicants traverse the rejection on the same grounds as provided above with respect to Shapiro alone and similarly applies it to Hansen.
The Examiner, in response, thus maintains the rejection for the reasons discussed above with respect to Shapiro alone.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
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.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
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