DETAILED ACTION
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 .
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.
Previous Rejections
Applicant’s arguments, filed April 13, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Status
Claims 2-4, and 13 are canceled.
Claims 1, 5-12, and 14-15 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Obviousness Rejection
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.
1) Claims 1, 5-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Tsunoda (WO 2004/032915 A1; in Japanese; citation below taken from the machine translation provided by EPO, cited herein as “Tsunoda ‘915”; of record), in view of Eto (JP 2010189301 (A), in Japanese; citation below taken from the machine translation provided by EPO; each of record).
Claim 1 is drawn to a method for treatment of an infection caused by a transient respiratory virus, generating a localized effect in a nasopharyngeal mucosa by administration of a synthetic lysine analog such as tranexamic acid, epsilon-aminocaproic acid, or AZD 6564 in the form of a spray solution.
Tsunoda ‘915 is drawn to an anti-influenza virus agent comprising tranexamic acid (Abstract). Tsunoda ‘915 teaches the agent is administered topically in the form of plasters, liquids, suspensions, tinctures, ointments, nasal drops, inhalants, liniments, lotions, aerosols, a mouthwash, or a throat spray (pg 3: 86-94). Tsunoda ‘915 teaches that tranexamic acid is the antiviral agent (pg 6, claim 1). Tsunoda ‘915 teaches that the concentration of tranexamic acid in either nasal drops or an inhalant formulation is from 0.1% to 5.0% (pg 3: 107-111), overlapping the claim 1 range. Because the claimed range overlaps with the range disclosed by the prior art, a prima facie case of obviousness exists.
For the limitation of claim 12 of the spray volume, one of ordinary skill is able to determine the necessary volume of spray given the concentration of tranexamic acid taught by Tsunoda ‘915 as effective. As set forth in MPEP 2144.05(II)(A):
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
For claims 14 and 15, Tsunoda ‘915 teaches: “The anti-influenza virus agent the preventive and / or therapeutic agent for influenza virus infection of the present invention is administered to a patient infected with or at risk of being infected with influenza virus” (pg 2, lines 53-55).
While Tsunoda ‘915 teaches administration of tranexamic acid by nasal drops, throat spray, and other means of topical application (see above), Tsunoda ‘915 does not explicitly teach a spray to the nasopharyngeal mucosa as recited in claim 1.
Eto teaches pharmaceutical compositions delivered via known inhalation methods such as by nebulizer, a spray inhaler, a dry powder inhaler (pg 4, [0009]). While Eto teaches delivery to the lower respiratory tract, the means of delivery would also necessarily deposit the spray drops in the nasopharyngeal mucosa since the spray is taught as administered via the mouth or nose (Abstract).
Regarding the claim 1 limitation of “generating a localized effect in a nasopharyngeal mucosa of the subject by topically administering a solution as a spray,” since Tsunoda ‘915 teaches a topical administration of tranexamic acid is useful for treating an infection caused by the influenza virus and Eto teaches the topical administration of tranexamic acid may be by administration of a spray for the treatment of an influenza virus infection, it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure. See MPEP 2112(II): “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.” In the instant case, the combination of Tsunoda ‘915 and Eto teach the claimed amount of tranexamic acid is applied topically as a spray to the nasopharyngeal mucosa of a subject to treat an infection caused by influenza. Further support for this position is recited in MPEP 2145(II): ”Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 201 USPQ 658 (CCPA 1979). Granting a patent on the discovery of an unknown but inherent function would remove from the public that which is in the public domain by virtue of its inclusion in, or obviousness from, the prior art. In re Baxter Travenol Labs, 21 USPQ2d 1281 (Fed. Cir. 1991).
Regarding the claim 5 limitation of “wherein the solution comprises 10% w/v tranexamic acid,” while the concentration is outside the range taught by Tsunoda ‘915, the claim is rejected by the teachings of Tsunoda ‘915. As set forth in MPEP 2144.05(A): “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” As taught by the combination of Tsunoda ‘915 and Eto, nasal sprays containing 5% tranexamic acid are effective in treating influenza infections.
For the limitations of claims 6, 8, 9, and 11 regarding of topical administration of a second, third, or fourth dose within 24 hours, Tsunoda ‘915 teaches the agent may be administered 1-10 times daily (pg 3: 101-114).
For the limitation of claims 7 and 10 of topical administration of a second and third dose comprising 10% tranexamic acid, the amount of 10% is considered obvious over Tsunoda ‘915, as discussed above.
The skilled artisan would have expected success in substituting Eto's nasal spray for the nasal drops taught by Tsunoda ‘915 because Eto teaches that application in the form of a nasal spray or nebulizer is an effective method of applying tranexamic acid to the oral or nasal area for the treatment of influenza infection.
Examiner’s Reply to Attorney Arguments dated 4/13/2026
1. Rejection of claims 1-2, 4-12, and 14-15 under 35 U.S.C. 103 over Tsunoda '915 and Eto
The applicant argues on page 5 of the Remarks dated 4/13/2026 that “nothing in the cited art teaches or suggests a method for treatment of an infection in a subject caused by one of a common cold virus and an influenza virus by generating a localized effect in a nasopharyngeal mucosa of the subject by topically administering a solution as a spray.”
The Examiner acknowledges the arguments presented, but does not consider them persuasive. As discussed above, Tsunoda ‘915 teaches application of nasal drops comprising tranexamic acid for the treatment of influenza A or B, and Eto teaches pharmaceutical compositions delivered via inhalation methods such as by nebulizer or a spray inhaler. Eto also teaches delivery to the respiratory tract, and the nebulizer or spray inhaler method of delivery would necessarily deposit the spray drops in the nasopharyngeal mucosa since the spray is taught as administered via the mouth or nose to the nasopharyngeal mucosa.
The applicant emphasizes throughout the response of 4/13/2026 that the effect of the claimed method is limited to a topical effect. The Examiner disagrees with this assertion. The applicant has not provided any factual evidence that the tranexamic acid method claimed affords only a topical effect. As such, this is considered an unsupported argument by applicant, and such argument cannot take the place of evidence in the record. See MPEP 2145(I).
The Examiner further cites the evidentiary art of Furubayashi (Biol. Pharm. Bull. 30(3) 608-611 (2007)) to counter Applicant’s assertion. Furubayashi discloses “Drugs applied to the nose in in vivo physiologic condition undergo absorption from the nasal cavity and the gastrointestinal (GI) tract because drug solution in the nasal cavity, together with mucus layer, is cleared to pharynx and then to the GI tract by coordinated beat of the cilia on nasal epithelial cells.” See the Abstract. That is, drugs such as tranexamic acid, applied to the nasopharyngeal mucosa as presently claimed, are directed by the motion of cilia on nasal epithelial cells to the pharynx and into the gastrointestinal tract. As concluded by Furubayashi, “It is important to take into consideration that the drug is absorbed both from the nasal cavity and GI tract after nasal administration (pg 611, Conclusions). As such, drugs applied to the nasal cavity have both local and systemic effects.
The applicant argues on page 5 of the Remarks dated 4/13/2026 “Tsunoda '915 is limited to oral or parenteral administration, which are terms of art distinct from "topical" administration.” The applicant further argues “As established in pharmacology, "topical" administration refers to a local effect at the site of application, whereas "oral" and "parenteral" administrations are intended for systemic effect via the bloodstream. Tsunoda '915 explicitly directs administration to be "oral or parenteral. While Tsunoda '915 mentions nasal drops, the objective is clearly systemic absorption to treat the body.”
The Examiner acknowledges the arguments presented, but does not consider them persuasive. As discussed above, Tsunoda '915 teaches nose drops as a method of application. It is noted that the applicant contends that Tsunoda '915 intended for the nasal drops to be transported to the blood stream, and then dispersed through the bloodstream throughout the body (pg 5 of the Remarks) but fails to explain how Tsunoda '915's tranexamic acid formulation enters the bloodstream without first being topically administered to and absorbed by tissues in the nasal cavity.
The applicant argues in the section entitled “Intranasal Administration” on page 6 of the Remarks “that formulations administered to achieve local effects are defined in the field as ‘topical,’ such as those claimed, and that formulations administered to the skin for systemic effects are considered ‘transdermal, citing Lunter (Pharmaceutics 2024, 16, 817).
The Examiner acknowledges the arguments presented, but does not consider them persuasive. Lunter is drawn to topical and transdermal drug delivery to skin, not a mucosal membrane such as the nasopharyngeal mucosa. “Skin” is defined by Lunter as “the largest organ and a multifunctional interface between the body and its environment. It acts as a barrier against cold, heat, injuries, infections, chemicals, radiations or other exogeneous factors, and it is also known as the mirror of the soul (Abstract). As such, the structure and purpose of skin is vastly different than that of the mucosa lining the nasopharyngeal surfaces.
The applicant argues in the section entitled “Established Terminology of Drugs Administered to the Skin” on page 5 of the Remarks that:
For example, the location of administration within the complicated nasopharyngeal area to be targeted is one such factor. As is described by Gao (2020), the back of the nasopharyngeal area contains ciliated cells designed to clear foreign bodies down the back of the throat. Thus, a drug (e.g., tranexamic acid) deposited in the anterior part of this space avoids ciliary clearance and "has longer retention time, which is beneficial for the absorption of drugs for systemic effect….. Middle meatus is the best targeted position for the therapy of sinusitis disorders
The applicant concludes that:
a person having ordinary skill in the art would recognize that Tsunoda '915 described nasal drops for intranasal administration, and omitted nasal spray, because the drops would be heavier than a spray and would be deposited at the front of the nasal space and have longer retention time for absorption into the blood stream to achieve the systemic effect Tsunoda '915 intended.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The instant claims do not recite a specific area of the nasopharyngeal mucosa to deposit the spray of the claimed method. The instant claims, as well as the instant disclosure, do not recite a specific particle size of the spray droplets. As such, in both arguments, the applicant is reciting features that are not claimed.
Regarding the prior art of Eto, the applicant argues:
The office alleges that a combination of Tsunoda '915 and Eto reaches the claimed Methods. Applicant strongly disagrees and asserts that Eto fails to cure the deficiencies of Tsunoda '915 because a person having ordinary skill in the art would recognize that adding a nasal spray to Tsunoda '915 based on Eto does not alter the fundamental limiting factor of the primary reference, which requires the agent to be administered "orally or parenterally" rather than "topically."
Emphasis by applicant.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. As discussed above, the prior art of Tsunoda '915 teaches the limitation of application of nasal drops comprising tranexamic acid. As set forth in MPEP 2145(IV), “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references.”
The applicant argues on page 7 of the Remarks:
while delivery to the lungs necessitates a high-velocity, high-volume spray with fine droplets (less than 10 µm) to ensure deep penetration, a nasal spray intended for local or systemic effect in the nasal cavity requires the opposite; according to Gao (see Gao page 254, left column), droplets smaller than 10 µm are ineffective for nasal delivery as they bypass the nasal cavity and enter the lungs.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The cited portion of Guo relates to “Droplet size distribution.” However, none of the instant claims are drawn to droplet size, and the instant rejections are likewise not drawn to droplet size. Furthermore, neither the prior art of Tsunoda ‘915 nor Eto mentions application of the drug to the lung, and the cited evidentiary art of Furubayashi discloses that the drug that is not absorbed into the mucosa enters the gastrointestinal tract.
The applicant argues the following on page 8 of the Remarks regarding “Long-Felt Need and Failure of Others”:
Applicant asserts that the claimed methods are patentable over the cited art at least because they address a previously unfilled gap in pharmacological treatment and fulfill a long-felt need for such antiviral products. MPEP 716.04.
Despite the long-standing use of tranexamic acid in diverse medical contexts-such as its proven efficacy in topical applications to reduce surgical bleeding and treat epistaxis (i.e., nose bleed) as documented by Ker et al. (2013)-the Applicant maintains that no tranexamic acid antiviral products currently exist on the market. Ker, K., Beecher, D., & Roberts, I. (2013). Topical application of tranexamic acid for the reduction of bleeding. The Cochrane database of systematic reviews, 2013(7), CD010562. While Ker et al. (see Ker at Page 1) focus on hemostatic applications, Applicant has provided working examples of tranexamic acid functioning as an antiviral agent when applied topically, specifically while being safely administered within a high concentration range (e.g., 10% or more). Applicant asserts that one having ordinary skill in the art would understand that, while such a high concentration can be administered in the small amount needed for topical treatment in the thin nasal mucosa, if the large amount of tranexamic acid needed to reach such a concentration systemically for antiviral effect were administered, it would be highly toxic.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. First, the utility of tranexamic acid as a method of stopping bleeding is not instantly claimed and is not considered relevant to the claimed invention. Secondly, applicant provides no “objective evidence that an art recognized problem existed in the art for a long period of time without solution,” as set forth in MPEP 716.04(I). In fact, antivirals are available, as of the filing date of the present application, for treating influenza, including inhaled zanamivir (Relenza®), as discussed by Amarelle (Arch Bronconeumol. 2017;53:19–26).
CONCLUSION
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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