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 .
DETAILED ACTION
Claims 1-3, 14-18, 26-30, 39, 40 and 42 are pending in the application. Claims 1-3, 14-18, 26-30, 39, 40 and 42 are rejected. Claims 2, 16-18, 27, 39 and 42 are objected to.
Priority
This application is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2023/064902, filed on March 24, 2023, which claims benefit of Provisional Application No. 63/490,664, filed on March 16, 2023, which claims benefit of Provisional Application No. 63/371,033, filed on August 10, 2022, which claims benefit of Provisional Application No. 63/269,943, filed on March 25, 2022.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on July 25, 2025 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Claim Objections
Claims 2, 16-18, 27, 39 and 42 are objected to because of the following informalities:
Claim 2 should be amended to include a period at the end of the claim for proper claim format.
Claim 16 should be amended to include the word “the” before the word “psoriasis” for sake of clarity and consistency.
Claim 17 should be amended to include the word “the” before the word “psoriatic” for sake of clarity and consistency.
Claim 18 should be amended to delete the period appearing after “at least an American College of Rheumatology (ACR) 20 response” for proper claim format.
Claim 27 should be amended to recite, “The method of claim 1” for sake of clarity and consistency.
Claim 39 should be amended to recite, “wherein the patient has a body surface area (BSA) of at least...” for sake of clarity and consistency.
Claim 42 should be amended to recite, “...comprising administering to a patient a therapeutically effective amount...” for sake of clarity.
Appropriate correction is required.
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 1-3, 14-18, 26-30, 39, 40 and 42 are rejected under 35 U.S.C. § 103 as being unpatentable over Masse et al. (U.S. PGPub. No. 2019/0031664 A1; January 31, 2019) in view of Wu (Am J Manag Care. 2017;23:S403-S416).
Determining the scope and contents of the prior art (See MPEP § 2141.01)
Masse et al. “provides compounds, compositions thereof, and methods of using the same for the inhibition of TYK2, and the treatment of TYK2-mediated disorders.” See e.g., the abstract. For instance, Masse et al. teach the following Example 40/Compound I-908 (see e.g., page 127):
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Regarding 1-3, 16, 17, 26-30 and 40, the above prior art Compound I-908 corresponds to the instantly claimed Compound 1. Masse et al. teach Compound I-908 is “useful in the treatment of inflammatory or allergic conditions of the skin, for example psoriasis...[and] may also be used for the treatment of other diseases or conditions, such as diseases or conditions having an inflammatory component, for example,... psoriasis[] and psoriatic arthritis.” See e.g., paragraphs [0242], [0243] and [0244]. Note that the intended results recited in instant claims 3, 18, 26 and 27 are drawn towards characteristics that would necessarily result from employing the instantly claimed method (i.e., administering Compound 1) and are, therefore, considered to be non-limiting. “Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP § 2112.01(II).
Ascertainment of the differences between the prior art and the claims (See MPEP § 2141.02)
Regarding instant claims 1, 2, 28-30 and 42, Masse et al. does not specifically teach the instantly claimed dosage/dosing requirements. However, Masse et al. does teach, for instance, “dosage levels of about 0.01 mg/kg to about 50 mg/kg and preferably from about 1 mg/kg to about 25 mg/kg, of subject body weight per day, one or more times a day, to obtain the desired therapeutic effect.” See e.g., paragraph [0275].
Regarding instant claims 14, 15, 39 and 42, Masse et al. does not teach patients with either plaque psoriasis or moderate-to-severe plaque psoriasis [e.g., body surface area (BSA) of at least about 10%). However, Wu teaches that plaque psoriasis is “the most common form of psoriasis, [and] affects approximately 80% to 90% of patients with psoriasis.” See e.g., page S403. Wu further teaches that “[a]pproximately 80% of patients with psoriasis have mild to moderate disease and the remainder have moderate to severe disease.” See e.g., page S403. Wu also teaches that “[t]ypically, an oral systemic agent is used for patients with initially extensive disease or severe psoriasis (BSA>10%).” See e.g., page S408.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1, 2, 28-30 and 42, it would have been obvious for a person of ordinary skill in the art to arrive at the instantly claimed dosing/dosage requirements based on the teachings of Masse et al. The optimization of result-effective variables, i.e., variables that achieve a recognized result, such as dosages or dosing frequencies are considered to be within the ability of the skilled artisan. “It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions.” In re Williams, 36 F.2d 436, 438 (CCPA 1929). Therefore, a skilled artisan would have been motivated to optimize the aforementioned result effective parameters as part of a routine optimization process. “[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).
Regarding instant claims 14, 15, 39 and 42: A skilled artisan endeavoring to treat the psoriasis patient population would be expected to encounter patients having the most common form of the disease (i.e., plaque psoriasis). Therefore, it would have been obvious to administer Compound I-908 taught by Masse et al. to patients with plaque psoriasis or moderate-to-severe plaque psoriasis. Wu teaches that the “treatment for psoriasis is guided by measures of disease severity” with topical treatments considered as “first-line therapy for mild psoriasis” while “[a]dditional therapies for the treatment of plaque psoriasis may be needed for patients for whom treatment fails or who have more severe and extensive disease.” See e.g., page S408. Furthermore, with respect to patients with severe plaque psoriasis, Wu teaches that “[c]linicians may escalate treatment with the use of traditional oral systemic agents for patients who do not achieve adequate response with phototherapy or topical treatment.” See e.g., page S408. Therefore, based on the combined teachings of the prior art, a skilled artisan would be motivated to employ the instantly claimed methods- at least in the interest of treating psoriasis and psoriasis disease subtypes.
Conclusion
No claims are allowed.
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/D.M.S./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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