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 .
Non-Final Rejection
The Status of Claims:
Claims 43-55 are pending.
Claims 43-55 are rejected.
DETAILED ACTION
1. Claims 43-55 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation of of 18236795 08/22/2023 (PAT 12128013), which is a continuation of 17653827 03/07/2022 (PAT 11771664), wjhich is a continuation of 17/227,568 04/12/2021 (PAT 11701331) ,which is a continuation of 16/773,654 01/27/2020 PAT 11007157, which is a continuation of 16/262,364 01/30/2019 PAT 10543181 and is a continuation of 16/277,865 02/15/2019 PAT 10588874 and said 16/262,364 01/30/2019 is a continuation of 15/590,708 (05/09/2017)(US 10213395,) which is a continuation of 14/760,039 (07/09/2015)(US 9687481) which is a 371 of PCT/US2014/012762 (01/23/2014), which claims benefit of 61/901,796 (11/08/2013) and claims benefit of 61/755,613(01/23/2013).
Drawings
3. The drawings filed on 10/2/24 are accepted by the examiner.
IDS
4. The IDS filed on 1/21/2025 are accepted by the examiner None.
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 43-55 are 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.
Enablement for “a method of treating atopic dermatitis, comprising administering to a subject a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt” is not present in the specification.
The specification does not elaborate how the atopic dermatitis
can be treated by an effective amount of a compound of formula (I) ; such information is crucial because the specification must reasonably convey to those skilled in the art that the applicants were in possession of the claimed invention as of the date of invention; furthermore, the specification must enable a person skilled in the art not only to make, but to use the claimed invention without undue experimentation. In this case, there must be a showing that allergic conjunctivitis can be treated.
In evaluating the enablement in question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
The Nature of the Invention
The nature of the invention in claim 43 is as followed:
43. (New) A method of treating atopic dermatitis, comprising administering to a subject a therapeutically effective amount of a compound of formula (I):
(RB
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or a pharmaceutically acceptable salt thereof, wherein: X is CH; Z is N; and Y is C with the -NH2 attached; p is0,1,2,or 3; each RB independently halogen, hydroxyl, carbamoyl, amino, or aryl; RA is
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;and each Qa is independently a C1-C6 straight chain alkyl.
The State of the Prior Art
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From Wikipedia, it teaches that atopic dermatitis is also often called simply eczema, but "eczema" is also used to refer to dermatitis, the larger group of skin conditions. Atopic dermatitis results in itchy, red, swollen, and cracked skin. Clear fluid may come from the affected areas, which can thicken over time.[2] The thickening phenomenon is known as lichenification.
Atopic dermatitis affects about 20% of people at some point in their lives. It is more common in younger children. Females are affected slightly more often than males. Millions of people have outgrown the condition.
While the condition may occur at any age, it typically begins in childhood, with varying severity over the years. In children under one year of age, the face, limbs, and much of the body may be affected. As children get older, the areas on the insides of the knees and folds of the elbows and around the neck are most commonly affected.[3] In adults, the hands and feet are commonly affected.[3] Scratching the affected areas worsens the eczema and increases the risk of skin infections. Many people with atopic dermatitis develop hay fever or asthma.
The cause is unknown but is believed to involve genetics, immune system dysfunction, environmental exposures, and difficulties with the permeability of the skin. If one identical twin is affected, the other has an 85% chance of having the condition. Those who live in cities and dry climates are more commonly affected. Exposure to certain chemicals or frequent hand washing makes symptoms worse. While emotional stress may make the symptoms worse, it is not a cause. The disorder is not contagious. A diagnosis is typically based on the signs, symptoms, and family history.
Treatment involves avoiding things that make the condition worse, enhancing the skin barrier through skin care, and treating the underlying skin inflammation. Moisturising creams are used to make the skin less dry and prevent AD flare-ups. Anti-inflammatory corticosteroid creams are used to control flare-ups. Creams based on calcineurin inhibitors (tacrolimus or pimecrolimus) may also be used to control flares if other measures are not effective.[2][9] Certain antihistamine pills might help with itchiness. Things that commonly make the condition worse include house dust mite, stress, and seasonal factors. The material of clothing worn from day-to-day can also make a difference—synthetic fabrics and wool are frequently found to aggravate conditions. Phototherapy may be useful in some people. Antibiotics (either by mouth or topically) are usually not helpful unless there is secondary bacterial infection or the person is unwell. Dietary exclusion does not benefit most people, and it is only needed if food allergies are suspected.[13] More severe AD cases may need systemic medicines such as ciclosporin, methotrexate, dupilumab, or baricitinib.
There is no known exact cause of AD; however, since it is classified as a multifactorial disease, it likely stems from a combination of environmental, immunologic, bacterial, and genetic factors.
For instance, it has become an increasingly common conjecture that a null filaggrin (FLG) gene plays a sizable role in the development of AD, although further study remains necessary.
No cure for AD is known, although treatments may reduce the severity and frequency of flares.[20] The most commonly used topical treatments for AD are topical corticosteroids (to get control of flare-ups) and moisturisers (emollients) to help keep control. Clinical trials often measure the efficacy of treatments with a severity scale such as the SCORAD index or the Eczema Area and Severity Index.
There is no really effective treatment for SLS. The skin can respond to the usual topical lotions and keratolytic agents, hut the neurologic symptoms have no specific therapy. Walking ability can often benefit from surgical procedures that improve the spasticity. The itchiness of some patients may respond to a drug called zileuton (Zyflo), but this drug is not approved by the FDA for use in children.Therefore, unlike the specification which describes that atopic dermatitis was caused by the implication of aldehyde toxicity in the pathogenesis, there are some other causes or unknown causes by which atopic dermatitis can be occurred.
The Presence or Absence of Working Examples
There is an example 4 of the method of treating allergic dermatitis comprising: administering to a subject in need thereof a therapeutically effective amount of a compound of formula (I).
In the examples, compound 9 prevented aldehyde-mediated cell death in neurons as shown in figure 2; compound 9 treatment resulted in the reduction of pro-inflammatory cytokines; the efficacy of compound 9 in treating contact and allergic dermatitis was measured (see pages 66-67). However, there are no actual working examples for treating atopic dermatitis in the specification. Also, the various compounds disclosed in the specification have no pharmacological data regarding the treatment. Thus, the specification fails to provide sufficient working examples as to how atopic dermatitis can be treated successfully by the compound of formula (I).
The breadth of the claims
The breadth of the claims is that the claimed compounds can treat atopic dermatitis without regards as to the clinical the side effects of the compounds on treating the claimed disease.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine whether or not the claimed compounds would provide a beneficial treatment of atopic dermatis.
The level of the skill in the art
The level of skill in the art is high. However, due to the unpredictability in the pharmaceutical art, it is noted that each embodiment of the invention is required to be individually assessed for physiological activity by in vitro and in vivo screening to determine which compounds exhibit the desired pharmacological activity for treating atopic dermatitis.
Thus, the specification fails to provide sufficient support of the claimed compounds for the treatment of atopic dermatitis. As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting the claimed compounds suitable for the claimed atopic dermatitis in order to practice the claimed invention.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001 (3/13/1997), 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 to test whether or not all the claimed compounds can be used to treat atopic dermatitis, which is encompassed in the instant claims, with no assurance of success.
Conclusion
Claims 43-55 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAYLOR V OH whose telephone number is (571)272-0689. The examiner can normally be reached 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAYLOR V OH/Primary Examiner, Art Unit 1625 7/22/2026
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