DETAILED ACTION
This office action is in response to the Applicant’s filing dated December 18th, 2023.
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/JP2022/019132 filed on April 27th, 2022; and claims benefit of foreign priority of JP2021-076617 filed on April 28th, 2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 1-10 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on December 18th, 2023. Acknowledgment is made of Applicant’s amendment of claims 1-10.
Claim Rejections - 35 USC § 112(a)
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 1-10 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 suppressing atopic dermatitis with KUS121 and KUS187, moisturizing skin by maintaining barrier function with KUS121, suppressing itching with KUS121, and suppressing symptoms of irritant contact dermatitis with KUS121, does not reasonably provide enablement for ameliorating any skin tissue abnormality with any compound of Formula (I). 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. This is a scope of enablement rejection.
To be enabling, the specification of the patent application 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 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
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 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). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
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. The nature of the invention and breadth of the claims
The invention relates to a method of ameliorating a skin abnormality.
Claims 1-10 are directed to a method of ameliorating a skin tissue abnormality comprising administering a compound of Formula (I). Thus, the claims are extremely broad with regards to the diseases to be treated, as well as the possible compounds that can be utilized.
2. The state and predictability of the art, and relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
The factor is outweighed, however, by the unpredictable nature of the art. It is well established that “the scope of enablement varies with the degree of unpredictability of the factors involved” and physiological activity is considered to be an unpredictable factor. See In re Fisher, 166 USPQ 18, at 24 (In cases involving unpredictable factors, such as most chemical reactions and physiological activity, the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved); Nationwide Chemical Corporation, et. al. v. Wright, et. al., 192 USPQ 95 (one skilled in chemical and biological arts cannot always reasonably predict how different chemical compounds and elements might behave under varying circumstances); Ex parte Sudilovsky 21 USPQ2d 1702 (Applicant’s invention concerns pharmaceutical activity. Because there is no evidence of record of analogous activity for similar compounds, the art is relatively unpredictable); In re Wright 27 USPQ2d 1510 (the physiological activity of RNA viruses was sufficiently unpredictable that success in developing specific avian vaccine was uncertain).
As illustrative of the state of the art, the examiner cites Lehmann et al, cited for evidentiary purposes, teaches that Xeroderma Pigmentosum is a skin tissue abnormality defined by extreme sensitivity to sunlight, resulting in sunburn, pigment changes in the skin and a greatly elevated incidence of skin cancers. There is no cure for XP, the skin effects can be minimized by rigorous protection from sunlight and early removal of pre-cancerous lesions (page 1, Abstract and Definition). Enjalbert et al, also cited for evidentiary purposes, teaches that Harlequin Ichthyosis is a devastating skin disorder caused by loss-of-function mutations in the gene ABCA12, and is poorly understood. There are no satisfactory treatments that have been developed (page 4798, Abstract). Kumetz et al, also cited for evidentiary purposes, teaches that Epidermolysis Bullosa Aquisita is a mucocutaneous blistering disorder characterized by skin fragility and the development of sub-epithelial blisters overlying sites of repeated minor trauma, specifically the hands, feet and extensor surfaces resulting in subsequent skin erosions and scarring. The primary focus of treatment is to prevent disease progression and serious complications of scarring by avoiding physical trauma and suppressing the immune system; but despite therapy, the clinical course is highly variable with some patients progressively worsening despite therapy (page 2, right column, second and third paragraphs; page 3, left column, last paragraph; page 3, right column, last paragraph).
“The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability of the art” In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970).
Accordingly, the more unpredictable an area is, the more specific enablement is necessary in order to satisfy the statutory requirements.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides data for suppressing atopic dermatitis with KUS121 in Example 1 (pages 21-22), moisturizing skin by maintaining barrier function with KUS121 in Examples 2-3 (pages 22-24), suppressing itching with KUS121 in Examples 4-5 (pages 24-25), suppressing symptoms of irritant contact dermatitis with KUS121 in Example 7 (page 26), and suppressing atopic dermatitis with KUS187 in Example 8 (page 26), but it is not sufficient to provide support for the full scope of compounds encompassed by the claims or for the full scope of conditions or disorders associated with all skin tissue abnormalities.
The specification provides no structure-activity relationship guidance indicating that the demonstrated activity of KUS121 or KUS187 is predictive across the full genus of compounds of Formula (I). It is noted that m is an integer selected from 0 to 4, and substituents can be hydrogen if m is 0; or a halogen, or much larger substituents such as an alkyl-substituted aryloxy group. Given the unpredictability of pharmacological activity across structurally diverse compounds, one skilled in the art would need to synthesize and test numerous embodiments to determine efficacy, which would be undue experimentation.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art (as discussed supra) and in the absence of experimental evidence commensurate in scope with the claims, the skilled artisan would not accept that any compound of Formula (I) could be predictably used to ameliorate all conditions or disorders associated with all skin tissue abnormalities.
Genentech Inc. vs. Nova Nordisk states, "[A] patent is not a hunting license. It is not a reward for a search but a compensation for its successful conclusion and 'patent 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" (42 USPQ 2d 1001, Fed. Circuit 1997). A review of the state of the art fails to reveal the mechanism of action or experimental data regarding the use of any claimed compounds or compositions to ameliorate all skin tissue abnormalities. Determining if any particular claimed compound would ameliorate a conditions or disorders associated with all skin tissue abnormalities would require synthesis of the compound, formulation into a suitable dosage form, and subjecting it to clinical trials or to testing in an assay known to correlate to clinical efficacy of such treatment. This is undue experimentation given the limited guidance and direction provided by Applicants.
Accordingly, the inventions of instant claims 1-10 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention a person of ordinary skill in the art would have to engage in undue experimentation with no assurance of success.
Conclusion
Claims 1-10 are rejected.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691