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, 01/16/2026, wherein the Amendment amended claim 11, and cancelled claims 12-14 and 16-18.
Claims 1-11 are pending.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected Group II in the reply filed on 08/15/2024.
Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim 11 is examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Double Patenting
Copending Application No. 19/239,326 is a divisional of the instant application, filed pursuant to a restriction requirement issued in the instant application. As such, this rejection is withdrawn.
REJECTIONS—MAINTAINED
The prior art references in the previous Office Action continue to be relied upon.
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 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.
(Maintained) Claim 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Report of Deliberation Results (published 03/09/2021, IDS of 04/17/2024).
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), meeting the limitations of instant claim 11.
The instant claims are product claims and not process of use claims. As such, the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. Since the prior art composition of The Report of Deliberation, is capable of performing the intended use recited in the last three lines of claim 11, these limitations are met. See MPEP 2111.02.
Moreover, The Report of Deliberation additionally teaches the following:
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
On pgs. 4-5, Remarks, Applicant argues that no evidence was shown that “Report of Deliberation Results” was made publicly accessible on March 9, 2021, as printed on NPL No. 5.
This argument has been fully considered, but is not found persuasive. The IDS of 04/17/2024 cites “Report of Deliberation Results” as NPL No. 5, with a publication date of 03/09/2021, wherein the document itself is dated 03/09/2021.
On pgs. 4-5, Remarks, Applicant further argues that the PMDA website always shows the date of official approval of a new medicine, not the date when the information of the new medicine is actually uploaded in the website.
This argument has been fully considered, but is not found persuasive. Applicant has not provided evidence that NPL Cite No. 5 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,” dated 03/09/2021. 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 (PTO-892 of 07/16/2025) 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 NPL Cite No. 5. Thus, this Nicholas Hall CHC In Action publication provides evidence that NPL Cite No. 5 is a publication with a public disclosure date of 03/09/2021, or that the contents of NPL Cite No. 5 were publicly disclosed between 03/09/2021 and 03/22/2021.
On pg. 6, Remarks, regarding the Nicholas Hall publication, Applicant argues that the publication mentions both Nasivin Medi, “the instant invention” and Nasivin M Spray, an oxymetazoline nasal spray from 2011.
This argument has been fully considered, but is not found persuasive. Nicholas Hall states the following:
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(pgs. 1-2).
Nicholas Hall clearly teaches Nasivin Medi as a drug approved from Rx to OTC. The publication then provides additional information that Sato, which produced Nasivin Medi, also launched Japan’s first OTC oxymetazoline nasal spray, Nasivin M, in April 2011. The Nicholas Hall publication is not equating Nasivin Medi to Nasivin M, and is not teaching Nasivin M as one of the three drugs approved by the Japan Ministry of Health, Labour & Welfare’s Pharmaceutical Affairs & Food Sanitation Council.
Further regarding the “Report of Deliberation Results,” Applicant has not provided evidence on the record, such as a 130(a) declaration, that the information provided in the “Report of Deliberation Results” is a disclosure derived from the Inventor, even though the report names Sato Pharmaceuticals, the instant assignee.
Per MPEP 2153.01(a):
AIA 35 U.S.C. 102(b)(1)(A) first provides that a disclosure which would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) is excepted as prior art if the disclosure is made: (1) one year or less before the effective filing date of the claimed invention; and (2) by the inventor or a joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor (i.e., an inventor-originated disclosure). Thus, a disclosure that would otherwise qualify as prior art under AIA 35 U.S.C. 102(a)(1) may not be used as prior art by Office personnel if the disclosure is made one year or less before the effective filing date of the claimed invention, and the evidence shows that the disclosure is an inventor-originated disclosure. What evidence is necessary to show that the disclosure is an inventor-originated disclosure requires case-by-case treatment, depending upon whether it is apparent from the disclosure itself or the patent application specification that the disclosure is an inventor-originated disclosure. . .The Office has provided a mechanism for filing an affidavit or declaration (under 37 CFR 1.130 ) to establish that a disclosure is not prior art under AIA 35 U.S.C. 102(a) due to an exception in AIA 35 U.S.C. 102(b). See MPEP § 717. In the situations in which it is not apparent from the grace period disclosure itself or the patent application specification that the disclosure is an inventor-originated disclosure, the applicant may establish that the AIA 35 U.S.C. 102(b)(1)(A) exception applies by way of an affidavit or declaration under 37 CFR 1.130(a). MPEP § 2155.01 discusses the use of affidavits or declarations to show that a disclosure was an inventor-originated disclosure made during the grace period.
On pgs. 6-7, Remarks, Applicant argues that the present invention is an employee invention made by Yoshitoshi Koyama, an employee of Sato Pharmaceutical Co., and that Applicant acquired the rights for the invention, including the right to obtain a patent, and manufacture and sales rights, and that the instant specification and “Report of Deliberation Results” contain tables that show identical results attained by the clinical trials conducted by Applicant, and that there is therefore no doubt that both the invention described in the patent specification and the invention described in the “Report of Deliberation Results” are derived from the inventor of the instant invention.
This argument has been fully considered, but is not found persuasive. A 130(a) declaration is required as evidence that the disclosure is derived from the Inventor, even though the report names Sato Pharmaceuticals, the instant assignee.
(Maintained) Claim 11 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by JP 2005-75735 to Shushi (published 2005, IDS of 04/17/2024).
Shushi exemplifies the following nasal drops:
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wherein Example 28 comprises 50mg/100mL oxymetazoline hydrochloride and
500mg/100mL chlorpheniramine maleate, meeting the limitations of instant claim 11.
The instant claims are product claims and not process of use claims. As such, the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. Since the prior art composition of Shushi is capable of performing the intended use recited in the last three lines of claim 11, these limitations are met. See MPEP 2111.02.
Response to Arguments
Applicant argues that NPL No. 2 in the IDS, “Technical Data of Respibien 56811,” dated 03/2010 is a nasal drop comprising 50mg/100mL of chlorpheniramine maleate and 50 mg/100 mL of oxymetazoline hydrochloride, wherein the amount of chlorpheniramine is far smaller than the instantly claimed amount. Applicant argues that this product as taught to have adverse reactions when oxymetazoline was administered nasally and chlorphenamine was administered orally, thereby providing evidence that the examples of Shushi are prophetic and are not enabled.
This argument has been fully considered, but is not found persuasive. Respibien is taught as a nasal spray solution comprising 0.5mg oxymetazoline hydrochloride and 0.5 mg chlorphenamine maleate (pg. 1, Respibien 56811, IDS of 04/17/2024). Under the “Adverse reactions” heading, the following is stated “During the period of use of oxymetazoline nasally and chlorphenamine orally at doses higher than those of this drug, the following adverse reactions have been reported, the frequency of which could not be accurately established” (pgs. 5-6).
Regarding this statement, it is first noted that it is not clear how this statement refers back to the nasal spray solution comprising 0.5mg oxymetazoline hydrochloride and 0.5 mg chlorphenamine maleate, since the chlorphenamine is not administered orally. Moreover, it is respectfully pointed out that all drugs are known to have adverse reactions/effects. Thus, it is not clear how the technical data of Respibien demonstrates that the examples of Shushi are a) prophetic, and b) not enabled.
Lastly, it is respectfully pointed out that [0060]-[0065] in the instant Specification teaches adverse effects of the instantly claimed composition.
On pg. 9, Remarks, Applicant argues that Examples 28-32 are prophetic examples since they are described in the present tense and were not subjected to any tests.
This argument has been fully considered, but is not found persuasive. It is not clear how present verb tense is indicative of a prophetic example, especially since Applicant argues that Examples 1-12 are “Working Examples,” and examples 1-12 are also in present verb tense.
It is next pointed out that 35 USC § 102(a)(1) clearly states 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.
In accordance with 35 USC 102(a)(1), Shushi clearly teaches a composition comprising:
50mg/100mL oxymetazoline hydrochloride and 500mg/100mL chlorpheniramine maleate (Example 28, Table 7, Shushi).
Though Applicant has not provided evidence that the examples of Shushi are prophetic, assuming arguendo that they are, it is respectfully pointed out that MPEP 2164.02 does not discuss verb tense as an indicator of prophetic or working examples. In reference to 35 USC 112(a), MPEP 2164.02 states, “The courts have further cautioned that the presence of prophetic examples alone should not be the basis for asserting that a specification is not enabling; rather, a lack of operative embodiments and undue experimentation should be determinative.”
Lastly, 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). 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).
(Maintained) Claim 11 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 6,824,762 to Haslwanter (published 2004, IDS of 04/17/2024), as evidenced by Safe Anaesthesia (PTO-892 of 07/16/2025).
Haslwanter teaches nasal spray compositions (title, abstract).Haslwanter teaches the following nasal spray compositions:
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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
0.05% oxymetazoline hydrochloride is 0.05g in 100mL, which equals 50mg in 100mL, meeting the limitations of instant claim 11.
The instant claims are product claims and not process of use claims. As such, the intended use of the composition is being considered to the extent that it limits the structure of the composition, but it is not treated as a process of using claim. Since the prior art composition of Shushi is capable of performing the intended use recited in the last three lines of claim 11, these limitations are met. See MPEP 2111.02.
Response to Arguments
On pg. 10, Remarks, Applicant argues that all the examples are described in the present tense, merely mentioning active ingredients, and that Haslwanter is silent as to differences based on effective ingredients and that Haslwanter does not provide test results. Applicant further argues that to anticipate under 102, a reference must disclose an invention that is enabled and possesses specific and substantial utility, and undue experimentation must not be required.
These arguments have been fully considered, but are not found persuasive. As discussed above, it is not clear how present verb tense is indicative of a prophetic example.
Regarding rejection under 102, 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.
In accordance with 35 USC 102(a)(1) and 102(a)(2), Haslwanter clearly teaches a composition comprising 50mg/100mL oxymetazoline hydrochloride and 500mg/100mL chlorpheniramine maleate.
Though Applicant has not provided evidence that the examples of Haslwanter are prophetic, assuming arguendo that they are, it is respectfully pointed out that MPEP 2164.02 does not discuss verb tense as an indicator of prophetic or working examples. In reference to 35 USC 112(a), MPEP 2164.02 states, “The courts have further cautioned that the presence of prophetic examples alone should not be the basis for asserting that a specification is not enabling; rather, a lack of operative embodiments and undue experimentation should be determinative.”
On pg. 10, Remarks, Applicant argues “in view of the fact that nasal compositions containing more than 50 mg of chlorpheniramine maleate and 50 mg of oxymetazoline hydrochloride are virtually denied by NPL No. 2, Technical Data of Respibien 56811, undue experimentation would be required to arrive at the instant invention.”
This argument has been fully considered, but is not found persuasive. This argument is responded to above in the “Response to Arguments” in reference to the “Shushi” rejection.
Lastly, 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). 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).
For these reasons, Applicant’s arguments are not persuasive to overcome the prior art rejections.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL 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.
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/LAUREN WELLS/Examiner, Art Unit 1622