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 1-20 are pending.
Claims 1-4, 6-14, and 16-20 are rejected.
Claims 5 and 15 are objected.
DETAILED ACTION
1. Claims 1-20 are under consideration in this Office Action.
Priority
2. It is noted that this application is a continuation in part of 18796266 08/06/2024 , which is a division of 17267608 02/10/2021 (PAT 12083134), , which is a 371 of PCT/US2019/046119 08/12/2019 and PCT/US2019/046119 , which has a priority of 62717051 08/10/2018.
Drawings
3. The drawings filed on 10/21/2024 are accepted by th examiner.
IDS
4. None.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 5 and 15 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1-4, 6-14, and 16-20 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 reducing inflammation in a subject having psoriasis, does not reasonably provide enablement for a method of reducing any inflammation in a subject having all kinds of inflammatory disorders. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to related to the invention commensurate in scope with these claims.
For a compound of anacardic acid (AA) to be effective for reducing an inflammation for any subject having an inflammatory disorder generally is contrary to medical science. Inflammation is a process which can take place in virtually any part of the body. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate the inflammatory reaction. There is no common mechanism by which all, or even most, inflammations arise. Mediators include bradykinin, serotonin, C3a, C5a, histamine, assorted leukotrienes and cytokines, and many, many others. Accordingly, treatments for inflammation process are normally tailored to the particular type of inflammation present, as there is no, and there can be no “magic bullet” against inflammation generally.
Inflammation is the reaction of vascularized tissue to local injury; it is the name given to the stereotyped ways tissues respond to noxious stimuli. These occur in two fundamentally different types. Acute inflammation is the response to recent or continuing injury. The principal features are dilatation and leaking of vessels, and recruitment of circulating neutrophils. Chronic inflammation or "late-phase inflammation" is a response to prolonged problems, orchestrated by T-helper lymphocytes. It may feature recruitment and activation of T- and B-lymphocytes, macrophages, eosinophils, and/or fibroblasts. The hallmark of chronic inflammation is infiltration of tissue with mononuclear inflammatory cells. Granulomas are seen in certain chronic inflammation situations. They are clusters of macrophages which have stuck tightly together, typically to wall something off. Granulomas can form with foreign bodies such as aspirated food, toxocara, silicone injections, and splinters.
Otitis media is an inflammation of the lining of the middle ear and is commonly caused by Streptococcus pneumoniae and Haemophilus influenzae. Cystitis is an inflammation of the bladder, usually caused by bacteria. Blepharitis is a chronic inflammation of the eyelids that is caused by a staphylococcus. Dacryocystitis is inflammation of the tear sac, and usually occurs after a long-term obstruction of the nasolacrimal duct and is caused by staphylococci or streptococci. Preseptal cellulitis is inflammation of the tissues around the eye, and Orbital cellulitis is an inflammatory process involving the layer of tissue that separates the eye itself from the eyelid. These life-threatening infections usually arise from staphylococcus. Hence, these types of inflammations are treated with antibiotics.
Certain types of anti-inflammatory agents, such as non-steroidal anti-inflammatory medications (Ibuprofen and naproxen) along with muscle relaxants can be used in the non-bacterial cases. The above list is by no means complete, but demonstrates the extraordinary breadth of causes, mechanisms and treatment (or lack thereof) for inflammation. It establishes that it is not reasonable to any agent to be able to treat inflammation generally.
Moreover, “ the treatment of inflammatory process such as Alzheimer’s disease “.by a compound of formula I is not present. The specification does not mention the use of the compound of formula I in the treatment of Alzheimer’s disease with any sufficient examples and tests.
Alzheimer's disease (AD), also referred to simply as Alzheimer's, is a chronic neurodegenerative disease that usually starts slowly and gradually worsens over time. It is the cause of 60–70% of cases of dementia. The most common early symptom is difficulty in remembering recent events. As the disease advances, symptoms can include problems with language, disorientation (including easily getting lost), mood swings, loss of motivation, not managing self care, and behavioral issues. As a person's condition declines, they often withdraw from family and society. Gradually, bodily functions are lost, ultimately leading to death. Although the speed of progression can vary, the typical life expectancy following diagnosis is three to nine years. The cause of Alzheimer's disease is poorly understood. About 70% of the risk is believed to be inherited from a person's parents with many genes usually involved. Other risk factors include a history of head injuries, depression, and hypertension. The disease process is associated with plaques and neurofibrillary tangles in the brain. A probable diagnosis is based on the history of the illness and cognitive testing with medical imaging and blood tests to rule out other possible causes. Initial symptoms are often mistaken for normal ageing. Examination of brain tissue is needed for a definite diagnosis. Mental and physical exercise, and avoiding obesity may decrease the risk of AD; however, evidence to support these recommendations is weak. There are no medications or supplements that have been shown to decrease risk. Affected people increasingly rely on others for assistance, often placing a burden on the caregiver. The pressures can include social, psychological, physical, and economic elements. Exercise programs may be beneficial with respect to activities of daily living and can potentially improve outcomes. Behavioral problems or psychosis due to dementia are often treated with antipsychotics, but this is not usually recommended, as there is little benefit with an increased risk of early death. No treatments stop or reverse its progression, though some may temporarily improve symptoms. The above list is by no means complete, but demonstrates the extraordinary breadth of causes, mechanisms and treatment (or lack thereof) for Alzheimer ‘s Disease. It establishes that it is not reasonable to any agent to be able to treat Alzheimer‘s Disease or any inflammatory process successfully.
The specification mentions that it is possible to treat various inflammatory disorders, such as inflammatory bowel disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, multiple sclerosis, optic neuritis, and inflammatory disorders of skins by administering to the subject an effective amount of anacardic acid (AA).
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. § 112, first paragraph, have been described. They are:
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,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
The Nature of the Invention
The nature of the invention in claims 1 and 13 is as followed:
A method of reducing inflammation in a subject in need thereof, wherein the method comprises administering to the subject an effective amount of anacardic acid (AA) having a structure:
PNG
media_image1.png
120
622
media_image1.png
Greyscale
or a pharmaceutically acceptable salt thereof.
13. A method of reducing inflammation in a subject in need thereof, wherein the method comprises administering to the subject an effective amount of anacardic acid (AA) or a pharmaceutically acceptable salt thereof.
The State of the Prior art
Wikipedia discloses that anacardic acids are phenolic lipids, chemical compounds found in the shell of the cashew nut (Anacardium occidentale). As they are closely related to urushiol, they also cause an allergic skin rash on contact,[1] known as urushiol-induced contact dermatitis. Anacardic acid is a yellow liquid. It is partially miscible with ethanol and ether, but nearly immiscible with water. Chemically, anacardic acid is a mixture of several closely related organic compounds. Each consists of a salicylic acid substituted with an alkyl chain that has 15 or 17 carbon atoms. The alkyl group may be saturated or unsaturated; anacardic acid is a mixture of saturated and unsaturated molecules.There is also a suspicion that inhibiting anacardic acids may arrest the growth of cancer tumors such as breast cancer. Anacardic acid (2-hydroxy-6-alkylbenzoic acid) provides resistance to small pest insects (aphids and spider mites). Anacardic acid kills methicillin-resistant Staphylococcus aureus (MRSA) cells more rapidly than totarol.
However, there are no conclusive data which allow the approval for reducing all kinds of inflammation in any subject having an inflammatory disorder
by administering the claimed anacardic acid.
The presence or absence of working examples
In the specification, there are some examples for using the claimed anacardic acid; for example , Fig. 2 depicts an exemplary Scheme 1 for a method of preparing an anacardic acid(AA); Fig. 3 depicts a pathway by which anacardic acid may inhibit expression of IL-17 and provide therapeutic effects on plaque psoriasis ; Figs. 4A-4B depict quantification of IL-17 inhibition according to methods and compositions.
However, there are no other examples for reducing inflammation on any other inflammatory disorders, such as inflammatory bowel disease, rheumatoid arthritis, multiple sclerosis, optic neuritis, and other kinds of inflammatory disorders of skins. Also, the specification does not contain any pharmacological data regarding the reduction of all other kinds of inflammatory disorders while using the claimed compound. Thus, the specification fails to provide sufficient working examples as to how all kinds of inflammation in any subject having any inflammatory disorders can be reduced successfully by the claimed compound without any unexpected negative effects of using the claimed compound.
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 whether or not the claimed compound can be led to exhibit the desired pharmacological activity for reducing all kinds of inflammation in any subject having any inflammatory disorders.
Thus, the specification fails to provide sufficient support for the reduction of all kinds of inflammation in any subject having any inflammatory disorders.
As a result, it necessitates one of the skilled artisans in the art to perform an exhaustive search for selecting right inflammatory disorders for the purpose of the reduction of inflammation in the subject suitable for the claimed compound 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 inflammation in the subject with any inflammatory disorders can be reduced by the claimed anacardic acid (AA) compound, which is encompassed in the instant claims, with no assurance of success.
Conclusion
Claims 1-4, 6-14, and 16-20 are rejected.
Claims 5 and 15 are objected.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAYLOR V OH/Primary Examiner, Art Unit 1625 7/30/2026
Prosecution Insights