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 .
DETAILED ACTION
This Office Action is in response to Applicant’s Arguments and Amendment filed, 03/23/2026, wherein the Amendment amended claim 1 and deleted claims 2-10.
Claim 1 is are pending.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(b)
Applicant’s amendment to claim 1 is sufficient to overcome this rejection.
35 U.S.C. § 112(d)
Applicant’s deletion of claim 10 is sufficient to overcome this rejection.
REJECTIONS—MODIFIED & MAINTAINED
In view of Applicant’s amendment to claim 1 that adds the limitation “with no additional active ingredients” and modifies the amount of chlorpheniramine maleate to 500 mg/mL and the amount of oxymetazoline hydrochloride to 50mg/mL, the prior art rejections have been modified.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(Slightly Modified) Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Report of Deliberation Results (published 03/09/2021, IDS of 06/16/2025).
NOTE: The publication date of this document on the 06/16/2025 IDS is 06/01/2021 (NPL Cite No. 5). However, in the 04/17/2024 IDS of the parent application, Application No. 18/638,204, the publication date of this same reference is 03/05/2021 (see NPL Cite No. 5).
The Report of Deliberation teaches Nasivin Medi, generically known as oxymetazoline hydrochloride/chlorpheniramine maleate (pg. 1). The ingredients of the product are 50mg/l00mL oxymetazoline hydrochloride and 500mg/100mL chlorpheniramine maleate (pg. 3).
The Report of Deliberation additionally teaches that this product treats acute rhinitis or allergic rhinitis. It is sprayed 2-3 times per dose into each nasal cavity once or twice a day, wherein the interval between applications is 10-12 hours. The product should not be used for more than one week in a row (pg. 3).
Response to Arguments and 130 Declaration
The declaration under 37 CFR 1.130(a) filed 03/23/2026 is insufficient to overcome the rejection of claim 1 based upon the 35 USC 102(a)(1) rejection over Report of Deliberation Results as set forth in the last Office action because the publication date of the Report of Deliberation Results is over one year prior to the instant effective filing date of 06/01/2022.
Applicant has not provided evidence that the Report of Deliberation Results was not publicly available on 03/09/2021, which is the date on the document and the publication date on Applicant’s filed IDS in the parent Application (IDS of 04/17/2024, NPL Cite No. 5).
On pgs. 4-5, Remarks, Applicant argues that the “Report of Deliberation Results,” which is IDS NPL No. 5, can be downloaded on the PMDA’s website and has a publication date of 05/31/2021.
This argument has been fully considered, but is not found persuasive. It is first respectfully pointed out that the examiner is not able to access this website. And while Applicant states that a report was published 05/31/2021 on the said website that contains both an Examination Report and the Report of Deliberation Results, this is not evidence that the Report of Deliberation Results was not published or publicly available on 03/09/2021, the date on the Report of the Deliberation Results and the publication date of record on the IDS filed by Applicant in the parent application (Application No. 18/638,204, IDS of 04/17/2024, NPL Cite No. 5).
On pgs. 6-7, Remarks, Applicant argues that PMDA does not always post the clinical trial data for a newly approved medicament on its website on the exact day of official approval, which can be verified by checking the timestamps to the Wayback Machine. On pg. 7, Applicant provides a chart that states the “Date of Official Approval” of four distinct drugs and the date on which the approval was published on the PMDA website. Applicant then points to MPEP 2128 which states that publications obtained via the Wayback Machine are deemed to be accessible at the date and time provided in the time stamp.
This argument has been fully considered, but is not found persuasive. The examiner agrees with MPEP 2128 and with the information provided on pg. 7 and the corresponding appendixes. However, Applicant has not provided evidence that the 03/09/2021 “Report of Deliberation Results,” is a confidential or private disclosure by having, for example, an official of the MHLW/PMDA provide evidence of non-public disclosure of the “Report of Deliberation Results.” In other words, there is no evidence showing that the 03/09/2021 “Report of Deliberation” was a private or non-public disclosure. Applicant is respectfully reminded that the arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965).
It is further noted that the examiner has accessed the Japanese PMDA website, but is unable to locate the referenced webpage. Additionally, a review of this website, did not provide further information regarding the approval process and dates of publication of “Report of Deliberation Results” for drugs.
Moreover, Nicholas Hall CHC In Action (Rx-to-OTC Switch Round-Up, published 03/12/2021, IDS of 07/24/2025) states that the Ministry of Health, Labour & Welfare’s (MHLW) Pharmaceutical Affairs & Food Sanitation Council approved the switch from Rx to OTC of Nasivin Medi, an oxymetazoline hydrochloride and chlorphenamine maleate nasal spray for rhinitis. Nicholas Hall CHC In Action has a publication date of 03/22/2021, 13 days after the Report of Deliberation Results. Thus, this Nicholas Hall CHC In Action publication provides evidence that the Report of Deliberation Results is a publication with a public disclosure date of 03/09/2021, or that the contents of the Report of Deliberation Results were publicly disclosed between 03/09/2021 and 03/22/2021.
For these reasons, the Declaration and Arguments are not persuasive to overcome the rejection.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(New) Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Respibien (Respibien 56811 Technical Data, published 2010, IDS of 06/16/2023, NPL Cite Nos. 2 and 3) in view of US 6,824,762 to Haslwanter (published 2004, IDS of 06/16/2025) and WO 97/46243 to Koochaki (published 1997, IDS of 06/16/2025), as evidenced by Safe Anaesthesia (PTO-892 of 12/30/2025).
Respibien teaches an antiallergic nasal spray solution comprising 0.5mg oxymetazoline hydrochloride and 0.5mg chlorphenamine maleate (pg. 1, 1., 2.). The spray is for local and temporary relief of nasal congestion in allergic rhinitis (pg. 1, 4.1.).
Respibien teaches one application in each nostril for a maximum of two times a day, every 12 hours (pg. 1, 4.2).
Respibien teaches administration for up to 3 days (pg. 3, 2nd paragraph).
As disclosed on pg. 10, Remarks (03/23/2026), Respibien 56811 comprises 50mg/100mL chlorpheniramine maleate and 50mg/100mL oxymetazoline hydrochloride.
While Respibien teaches a method of treating allergic rhinitis by spraying in a nostril, a composition comprising 50mg/100mL oxymetazoline hydrochloride and 50mg/100mL chlorphenamine maleate, up to twice a day, every 12 hours, for a period of up to 3 days, it differs from that of instant claim 1 in that it does not teach 500mg/100mL chlorpheniramine maleate.
Haslwanter teaches aqueous nasal spray compositions for use in a method of treating nasal conditions, such as post nasal drip (title, abstract; Col. 1, lines 63-64; Col. 2, lines 30-33).
Haslwanter teaches the following nasal spray compositions comprising chlorpheniramine maleate and oxymetazoline hydrochloride:
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(Cols. 5-6, Examples 1, 3 and 4).
As evidenced e-safe anaesthesia, %w/v is converted to mg/mL as follows:
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, and
0.5% chlorpheniramine maleate is 0.5g in 100mL, which equals 500mg in 100mL, and
0.05% oxymetazoline hydrochloride is 0.05g in 100mL, which equals 50mg in 100mL.
Koochaki teaches a nasal spray comprising chlorpheniramine and oxymetazoline for the treatment of seasonal or perennial allergic rhinitis (abstract; pg. 3, 1st paragraph; pg. 12, claims 1, 4; pg. 13, claims 9-10):
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(pg. 10, Example IV), wherein oxymetazoline is a decongestant, and chlorpheniramine is an antihistamine (abstract; pg. 5, lines 32-36)
As evidenced e-safe anaesthesia, %w/v is converted to mg/mL as follows:
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, and
0.5% chlorpheniramine is 0.5g in 100mL, which equals 500mg in 100mL
0.05% oxymetazoline is 0.05g in 100mL, which equals 50mg in 100mL.
Koochaki teaches administration once to three times per day, wherein a typical dose contains one to three spray per nostril (pg. 5, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the amount of chlorpheniramine maleate in Respibien to 5mg (500mg/100mL), to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Respibien, Koochaki, and Haslwanter are all directed toward nasal sprays comprising chlorpheniramine maleate/chlorpheniramine and oxymetazoline hydrochloride/oxymetazoline, for the treatment of allergic rhinitis,
-Koochaki and Haslwanter both teach administration of 500mg/100mL of chlorpheniramine maleate/chlorpheniramine in combination with 50mg/100mL oxymetazoline hydrochloride, and
- "[W]here 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 experimentation," MPEP 2144.05(II).
As such, an ordinary skilled artisan would have been motivated to make such selections, to predictably arrive at an optimized dosage that is effective to treat allergic rhinitis.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Response to Arguments
The above 35 USC 103 rejection is new. Arguments directed toward the prior art references applied above are addressed.
On pgs. 8-9, Remarks, Applicant states that pharmaceutical science is a “Science of Experimentation” and that clinical trials is of critical importance for a new medicament.
This statement is acknowledged.
On pg. 9, Remarks, Applicant states that Respibien 56811 is a nasal spray approved by the Spanish regulatory authority, as evidenced by IDS NPL No. 3, and that the date of authorization of Respibien 56811 is 02/01/1989.
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that the date of Publication on the Respibien 56811 document is March 2010.
On pgs. 9-11, Remarks, Applicant argues that the dosage of chlorpheniramine maleate in Respibien 56811 is greater than the instantly claimed dosage amount of chlorpheniramine maleate.
This argument has been fully considered, but is not found persuasive. Respibien 56811 is not relied upon as an anticipatory reference, but is relied upon in an obviousness rejection, wherein the teachings of Haslwanter and Koochaki, in combination with Respibien 56811, are relied upon to teach the instantly claimed dosage amount of chlorpheniramine maleate; one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
On pg. 10, Remarks, Applicant argues that IDS NPL No. 3 teaches that the maximum duration of treatment should not exceed 3 days in a row unless better medical criteria are met, and that if it is necessary to repeat administration, it should be done several days after the end of treatment, which is in contrast to the instant nasal spray which can be safely administered for a period of up to 7 days.
This argument has been fully considered, but is not found persuasive. The instant claim recites “for a period of up to 7 days.” As such, the teaching of up to 3 days of Respibien 56811, meets this limitation; although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
On pg. 11, Remarks, Applicant argues that Respibien 56811 only teaches the treatment of allergic rhinitis.
This argument has been considered, but is not found persuasive since the instant claim recites “treating acute rhinitis and/or allergic rhinitis” and “a patient with acute rhinitis and/or allergic rhinitis.”
On pg. 12, Remarks, Applicant argues that the results of the clinical trial of Respibien 56811 substantially negate the dosage of chlorpheniramine maleate and oxymetazoline hydrochloride exceeding that of Respibien 56811.
This argument has been fully considered, but is not found persuasive. It is first respectfully pointed out that Respibien 56811 states, on pg. 12, Remarks, that “at doses higher than those of this medicinal product, the following adverse reaction have been reported, the frequency of which could not be accurately established.” As such, Respibien 5688 states that these adverse reactions could not be accurately established. Moreover, it is respectfully pointed out that all pharmaceuticals are known to have adverse effects. Furthermore, based on the teachings of Haslwanter and Koochaki, as discussed in the above prior art rejection, an ordinary skilled artisan would have been motivated to modify the dosage amounts of chlorphenamine maleate to arrive at the instantly claimed amounts.
On pg. 13, Remarks, Applicant argues that the results of clinical trials exhibited unexpected differences in the overall efficacy of Respibien 56811 and Nasivin Medi, the “present claim.”
This argument has been fully considered, but is not found persuasive. Applicant has provided no data to substantiate these “unexpected differences.”
Applicant is reminded that unexpected results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
On pg. 14, Remarks, regarding the arguments directed toward Koochaki, it is respectfully pointed out that Koochaki is no longer relied upon as a primary reference in the rejections.
On pgs. 14-16, Remarks, Applicant argues that Koochaki and Haslwanter are written in present tense indicating that the examples are prophetic and not subjected to actual experimentation, and further argue that since they are prophetic they “offer limited probative value unless supported by a theoretical rationale or other evidence substantiating the expected efficacy.”
This argument has been fully considered, but is not found persuasive.
It is respectfully pointed out that 35 USC 103 states:
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.
and 35 USC § 102(a)(1) and (a)(2) clearly state that 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.
Koochaki and Haslwanter are printed publications filed one year prior to the effective filing date, and Koochaki is a WO patent document and Haslwanter is a US patent that are effectively filed before the instant effective filing date. Koochaki and Haslwanter teach compositions comprising 50mg/100mL oxymetazoline hydrochloride/oxymetazoline and 500mg/100mL chlorpheniramine maleate/chlorpheniramine.
As such, the teachings of Koochaki and Haslwanter clearly apply as prior art under 35 USC 102(a)(1), 102(a)(2) and 103.
Moreover, it is not clear how present verb tense is indicative of a prophetic example. Applicant has provided no data to substantiate this argument. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the inventor or at least one joint inventor. See MPEP 716.01(c).
As such, Applicant’s arguments are not persuasive to overcome the instant rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Examiner, Art Unit 1622
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