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.
Claim Status
Claims 1-15 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Written Description / New Matter Rejection
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 3 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 3 recites the limitation of “wherein the transient respiratory virus is one of a respiratory syncytial virus, a parainfluenza virus, a metapneumovirus, a rhinovirus, a coronavirus, an adenoviruses [sic], and a bocavirus.” The recited viruses are not disclosed in the specification as filed.
Indefiniteness Rejection
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 1 recites the term “transient respiratory virus.” As set forth in MPEP 2173.05(a), “Applicants need not confine themselves to the terminology used in the prior art, but are required to make clear and precise the terms that are used to define the invention whereby the metes and bounds of the claimed invention can be ascertained. During patent examination, the pending claims must be given the broadest reasonable interpretation consistent with the specification.” However, the term “transient respiratory virus” does not appear to be present in the specification and it is unclear what viruses are being claimed. It is noted that the term “transient viruses” is recited on a number of occasions (for example, [0017]-[0021], but the term is not defined and the specification only recites the examples of influenza virus and cold virus.
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 1-2, 4-12, 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”), in view of Eto (JP 2010189301 (A), in Japanese; citation below taken from the machine translation provided by EPO).
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); this teaching is taken to read on claims 2 and 3. Tsunoda ‘915 teaches that tranexamic acid is the antiviral agent (pg 6, claim 1). This teaching also reads on claim 4. 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.
2) Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Tsunoda ‘915 (cited above), in view of Eto (cited above), and Tsunoda ‘168 (JP 2008-115168 (A), in Japanese; citation below taken from the machine translation provided by EPO, cited herein as “Tsunoda ‘168”).
The teachings of Tsunoda ‘915 and Eto are discussed above.
The combination of Tsunoda ‘915 and Eto does not teach the transient respiratory virus is one of “a respiratory syncytial virus, a parainfluenza virus, a metapneumovirus, a rhinovirus, a coronavirus, an adenoviruses [sic], and a bocavirus.”
Tsunoda ‘168 teaches the missing element of the combination of Tsunoda ‘915 and Eto.
Tsunoda '168 teaches that tranexamic acid is an anti-adenoviral agent and prophylactic and/or therapeutic agent for adenoviral infection of the invention and can be administered as a parenteral formulation (pg 5, [0015]), and further teaches the method is useful for treating a cold (pg 9, claim 6).
While Tsunoda '168 does not specifically teach a method of topical administration of the tranexamic acid as a treatment for an adenovirus infection, one of ordinary skill in the art would expect that the topical method of administration of tranexamic acid for the treatment of a viral infection such as a cold (pg 3, twentieth line), as taught by Tsunoda '915, as well as the oral or nasal spray taught by Eto, would likewise be effective for the treatment of the adenovirus taught by Tsunoda '168 since Tsunoda '168 also teaches that the adenovirus infection may be a form of a cold (pg 9, claim 6).
3) Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tsunoda (cited above), in view of Eto (cited above), and Yamasaki (“Arginine Facilitates Inactivation of Enveloped Viruses,” Journal of Pharmaceutical Sciences, Vol. 97, NO. 8, 2008, 3067-3073)
The teachings of Tsunoda ‘915 and Eto are discussed above.
The combination of Tsunoda ‘915 and Eto does not teach the addition of arginine in an amount of 5 to 25 mM.
Yamasaki teaches the missing element of the combination of Tsunoda ‘915 and Eto.
Yamasaki teaches arginine acts as a virucidal agent versus influenza virus at a concentration of 0.1 M or 100 mM, and further teaches a concentration of 0.1 M is as effective as a concentration of 0.7 M (Abstract; pg 3070, Table 3).
One of ordinary skill in the art would have been motivated to optimize the amount of arginine recited in claim 13 to obtain the most effective anti-influenza composition also comprising tranexamic acid since determining the optimum values of result effective variables is ordinarily within the skill of the art. See MPEP 2144.05 (II) and In re Aller, 220 F.2d 454, 456 (CCPA 1955) ("[W]here 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."). Therefore, one of ordinary skill in the art would have had a reasonable expectation of success of optimizing the concentration of arginine in the spray composition of the combination of Tsunoda and Eto, which includes tranexamic acid, based on the disclosure of Yamasaki.
It is noted that the applicant has provided no factual evidence or data regarding the effectiveness of treating a respiratory virus utilizing the combination of tranexamic acid and any of the amino acids in the claimed range recited in claim 13.
CONCLUSION
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)272-6897. 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