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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on June 22, 2026 has been entered.
Status of Claims
Currently, claims 1-3, 6-15 and 17-24 are pending in the instant application and are under consideration in the instant application.
Information Disclosure Statement
The information disclosure statement (IDS) dated June 22, 2026 was in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the IDS documents were considered and a signed 1449 form is attached.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-3, 6-15 and 17-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of treating hypertension, does not reasonably provide enablement for the claimed method of prophylaxis of hypertension. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
(1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The nature of the invention: The instant invention pertains to a method for preventing (i.e. prophylaxis of) hypertension comprising administering to an individual a composition comprising a sartan.
The relative skill of those in the art: The relative skill of those in the art is high. The examiner notes that the knowledge and level of skill in this art would not permit one skilled in this art to assert a preventive therapeutic mode of administration and the skilled artisan could not immediately envisage the invention claimed.
The breadth of the claims: The instant claims are deemed very broad since these claims reads on the preventing hypertension comprising administering to a cat a liquid formulation comprising any sartan.
Regarding the Wands factor (4) the predictability or unpredictability of the art:
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970) indicates that the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that the recitation encompasses the preventing of hypertension in a cat comprising administering to any individual a liquid composition comprising any AT-1 antagonist, which is not known to have a single recognized cause. Applicant claims method for the prevention of hypertension in a cat, is not generally known to exist in this art; additionally, the disclosure is silent with regard to that which makes up and identifies the claimed method for preventing the said hypertension, which is seen to be lacking a clear description via art recognized procedural and methodological steps. In addition, the prevention of hypertension which includes diseases or conditions such as kidney disease, endocrine disorders, heart defects, and more does not have a single recognized cause. In fact, the aforementioned disease, is recognized as having many contributing factors, ranging from hereditary considerations, to lifestyles choices such as the diet and maintenance of bodily healthiness including pre-existing conditions. These are only a few of the factors that promote and/or are linked to hypertension. Applicant has not provided a description as how any cause (like the aforementioned) can be prevented, much less a description of how the said disease can be prevented. Furthermore, Applicant has not provided any clear description via art recognized procedural and methodological steps. Moreover, Applicant has not provided an adequate representation of the mode of treatment of said disease to provide a full, clear and precise indication that applicant is in possession of the members of the methodological and procedural steps which would enable the skilled artisan to practice this invention by preventing said disease.
Thus, the skilled artisan would view that the prevention of hypertension which includes treatment of an otherwise healthy individual by administering to said patient the specific compound herein, as being highly unpredictable.
In regard to these Wands factors, (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary:
Moreover, it is noted that the specification provides no working examples to the prevention of said cardiovascular disease.
Thus, the specification fails to provide clear and convincing evidence in sufficient support of the prevention of adverse effects in a patient in the instant claims. As a result, necessitating one of skill to perform an exhaustive search for the embodiments of preventing hypertension in any subject as recited in the instant claims suitable to practice the claimed invention. The specification provides insufficient guidance with regard to these issues and provides no working examples which would provide guidance to one skilled in the art and no evidence has been provided which would allow one of skill in the art to predict the efficacy of the claimed method with a reasonable expectation of success. Therefore, the prevention of the cardiovascular disease in an individual by the said method is not enabled by the instant disclosure.
Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors, and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein, a person of skill in the art would have to engage in undue experimentation, with no assurance of success.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alicia L. Otton whose telephone number is (571)270-7683. The examiner can normally be reached on Monday - Thursday, 8:00-6:00.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Fereydoun Sajjadi can be reached on 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALICIA L OTTON/Primary Examiner, Art Unit 1699
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