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 .
Priority
This application is a 371 of PCT/EP2021/059813 (04/15/2021) and claims foreign priority to FRANCE 2004022 (04/22/2020).
Status
Claims 8-12 and 14-15 are pending.
Rejections not reiterated in this action are withdrawn.
Claim Interpretation
“Dry eye syndrome” is defined in the instant specification (p. 2: “Dry eye syndrome is defined by the Dry Eye Workshop in 2007 as a multifactorial disease of the tears and ocular surface leading to symptoms of discomfort, visual disturbance and instability of the tear film with potential damage to the ocular surface.”) by reference to DEWS and whose cause includes allergies (DEWS Fig. 1; p. 77, 86). Thus, one of skill in the art would consider treating dry eye syndrome as including treating one of the known underlying causes of dry eye syndrome which includes allergies. Thus, the broadest reasonable interpretation of “treating dry eye syndrome” includes preventing further causes thereof, including treating allergies.
New 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 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.
Claims 8-12, 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Terrasse et al. (US20160251367) in view of Kari et al. (Curr Allergy Asthma Rep (2012) 12:232–239), Umezu et al. (Japan. J. Pharmacol. 38, 153-160 (1985)), Maurin et al. (EP0780121, citations to English translation) and DEWS (“The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye Work Shop (2007). 2007;5(2):75-92).
Regarding claim 8, Terrasse teaches an “eye lotion” comprising tritoqualine (claims 1 and 7) which is known for treating allergies ([0003]: “tritoqualine is a medicament which has been marketed in Europe in the form of 100 mg tablets for treating allergies.”).
Terrasse does not specifically teach a method of treating “dry eye”.
Kari teaches treatment and prevention of ocular allergy conditions, including dry eye, with the goal of preventing dry eye by calming inflammation (p. 233: “The main goal of treatment is to calm the inflammation early and to prevent complications that can threaten vision and cause dry eye.”) which can be accomplished with mast cell stabilizers (p. 235: “PAC is often connected to dry eye, which influences therapy. Therapy should be started without delay and be intensive enough and last long enough. Milder cases can be treated with topical mast cell stabilizers”; p. 236: in NAEC “Because of the common coexisting dry eye, preservative-free mast cell–stabilizing agents are recommended.”).
Umezu teaches tritoqualine acts via inhibiting mast cell release of histamine (a mast cell stabilizer) (Abstract).
Maurin teaches treatment of “dry eye” with an “eye lotion” (title, abstract).
One of ordinary skill in the art following the teaching of Terrasse formulating an “eye lotion” to treat allergies would have also considered the composition’s use in preventing ocular allergy conditions such as dry eye as taught by Kari. One of ordinary skill in the art would have also been motivated by the mechanism taught by Kari in using mast cell stabilizers which Umezu teaches is a mechanism of action of tritoqualine. Furthermore, one of ordinary skill in the art formulating Terrasse’s eye lotion comprising tritoqualine for the treatment of allergies would have considered Maurin’s formulation because they are in the same field of endeavor of treating eye conditions, including “dry eye” which is defined in the instant specification (p. 2: “Dry eye syndrome is defined by the Dry Eye Workshop in 2007 as a multifactorial disease of the tears and ocular surface leading to symptoms of discomfort, visual disturbance and instability of the tear film with potential damage to the ocular surface.”) by reference to DEWS and whose cause includes allergies (DEWS Fig. 1; p. 77, 86). Thus, one of ordinary skill in the art would have had a reasonable expectation of success in treating dry eye disease through addressing one of the known underlying causes of allergies through the administration of an eye lotion having an effective amount of tritoqualine and arrive at the claimed invention.
Regarding claims 9-11 further limiting the effective amount based on other conditions or causes, one of ordinary skill in the art would consider dose optimization as routine as the effective amount is a well-known results effective variable requiring optimization. In the course of optimization, one of ordinary skill in the art would have considered all of the known associated conditions related to dry eye disease including those specifically described by DEWS (p. 76-77; Fig. 1; p. 97 (pain)).
Regarding claim 12 requiring a carbomer-based humectant, Maurin teaches “Carbopol 980” (p. 2/12) which one of ordinary skill in the art routinely utilizes in such formulations.
Regarding claim 14, one of ordinary skill in the art would have considered packaging in the form of an ophthalmic eye drop as suggested by Terrasse (eye lotion) and Maurin (p. 1/12: “Ready-to-use eye drops”) and arrive at the claimed invention.
Regarding claim 15 requiring “at least one” deuterated methyl, given the natural abundance of deuterium (0.0156%) one deuterium would be inherently present in the obvious formulation.
Thus, the claims are rejected as obvious.
Response to Remarks - 35 USC § 103
Applicant argues Terasse does not specifically teach treating dry eye. As detailed above and in the claim interpretation section, the broadest reasonable interpretation of treating dry eye would include preventing the cause of dry eye, i.e. allergies. In addition, one of skill in the art would have considered the teaching of Kari and Umezu regarding the mechanism of action of tritoqualine which was shown to be a mast cell stabilizer and considered substituting the known equivalent and arrive at the claimed invention with a reasonable expectation of success.
Applicant makes arguments using the phrase “unexpected results” (p. 6, para. 6) but does not otherwise explain how the claimed invention shows unexpected results.
Applicant argues that the prior art teaches away from the claimed invention because of a statement in DEWS on page 86 of “Ocular allergy was noted to be a risk factor for dry eye in
the Beaver Dam study, although the concomitant use of systemic medications, such as antihistamines, was recognized as a potential contributor.” The statement is not a clear teaching away, and merely recognizes an association. In addition, the statement when taken together with the prior art as a whole does not teach away from the claimed invention. In contrast to a potential contribution of antihistamines, Kari specifically teaches prevention of dry eye by calming inflammation by administering mast cell stabilizers (p. 233: “The main goal of treatment is to calm the inflammation early and to prevent complications that can threaten vision and cause dry eye.”; p. 235: “PAC is often connected to dry eye, which influences therapy. Therapy should be started without delay and be intensive enough and last long enough. Milder cases can be treated with topical mast cell stabilizers”; p. 236: in NAEC “Because of the common coexisting dry eye, preservative-free mast cell–stabilizing agents are recommended.”). One of ordinary skill in the art considering the teaching of the prior art as a whole would find the specific recommendations of Kari to use a therapeutic such as tritoqualine. Furthermore, the alleged teaching away is not specific to tritoqualine and thus does not clearly teach away from the claimed invention. Therefore, weighing the evidence by a preponderance of the evidence leads to the conclusion that the claimed invention is obvious.
Conclusion
No claim 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 ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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, Jeffrey Lundgren can be reached at (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626