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 .
Status of the Claims
The Office Action is in response to the application filed April 19, 2024. Claim 35 is being examined on the merits herein.
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.
Claim 35 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated: The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1 The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by 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 breadth of the claims 5) predictability of the art 6) the amount of direction or guidance provided 7) the presence or absence of working examples and 8) the quantity of experimentation necessary. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
(1), (6), (7): The nature of the invention, the amount of direction or guidance provided, the presence or absence of working examples:
The claim is directed to a method of treating and preventing multiple distinct diseases using the pyrazolopyridazine compound recited in the instant claim. The specification does not demonstrate the inventors were in possession of the claimed therapeutic methods at the time of filing. Although the specification identifies the chemical structure of said pyrazolopyridazine compound and the synthesis thereof, the specification does not include any experimental data, in vitro studies, animal models, or clinical evidence demonstrating the effectiveness of the compound to treat or prevent any of the recited diseases. The specification contains only prophetic statements asserting that the pyrazolopyridazine compound “can” be administered [000227] and recitation of numerous illustrative proteopathies (table 3-5, by way of example).
The Cleveland Clinic (Sickle Cell Anemia: Symptoms, Causes & Treatment) establishes that sickle cell anemia is an inherited blood disorder (i.e., it’s genetic), so administering the recited compounds is not expected to prevent this disease. Moreover, regarding treatment the recited compounds are not among the few recognized treatments of sickle cell disease. Thus, there remains a great level of unpredictability of treating sickle cell disease.
Additionally, the reference by Basak (Cellular Molecular Life Science, 2021) establishes that even in 2021 there was no cure or approved treatment for CLN5 Batten disease, so by inference there was also no cure or approved treatment of this disease on Applicant’s earliest effective filing date of June 11, 2015. Consequently, there is great unpredictability in treating or preventing Finnish variant late infantile CLN5/Batten disease and it would impose an undue burden on the ordinary skilled artisan to practice the claimed method.
Further, Vermilion (https://www.medlink.com/articles/batten-disease) teaches that Batten disease, or neuronal ceroid lipofuscinosis, comprises 13 genetically distinct disorders that differ by causative gene, gene product, and biological process. This further corroborates the notion that there is great unpredictability in treating or preventing Batten disease and would impose an undue burden on the ordinary skilled artisan to practice the claimed method.
Applicant has not provided sufficient written description that would enable the skilled artisan to make and/or use the invention.
Conclusion
Claims 35 is not allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAHAR JAVANMARD whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622
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