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 24-46 are pending.
Claims 24-32, and 36-46 are rejected.
Claims 33-35 are objected.
DETAILED ACTION
1. Claims 24-46 are under consideration in this Office Action.
Priority
2. It is noted that this application is a 371 of PCT/EP2023/068918 07/07/2023 ,
which has a foreign priority document, EPO EP22306025.2 07/08/2022.
Drawings
3. The drawings filed on 1/06/2025 were accepted by the examiner.
IDS
4. The IDS filed on 4/16/25 were reviewed by the examiner.
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 33-35 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 38 is rejected under 35 U.S.C. 101 because the claimed recitation of a use, without setting forth any steps involved in the process, results in an
improper definition of a process, i.e., results in a claim which is not a proper
process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ
678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149
USPO 475 (D.D.C. 1966).
-
-
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 38 provides for use as for a medicament, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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 24-31 and 39-40 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for treating specific diseases, does not reasonably provide enablement for preventing a disease selected from the group consisting of: amyloidosis, pain, neurodegenerative diseases and neuroinflammatory diseases in a subject.
. 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. Applicants are not enabled for preventing any of these diseases. The only established prophylactics are vaccines not of a compound of formula (I) such as present here. In addition, it is presumed that “prevention of the disease selected from the group consisting of: amyloidosis, pain, neurodegenerative diseases and neuroinflammatory diseases in a subject” would require a method of identifying those individuals who will develop the claimed conditions before they exhibit symptoms. There is no evidence of record that would guide the skilled clinician to identify those who have the potential of becoming afflicted.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art, and the breadth of the claims”, In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546. 1) As discussed above, preventing the diseases requires identifying those patients who will acquire the disease before the disease selected from the group consisting of: amyloidosis, pain, neurodegenerative diseases and neuroinflammatory diseases occurs. This would require extensive and potentially opened ended clinical research on healthy subjects. 2)
The passage spanning line 18,page 9 to line 4, page 11 lists the diseases Applicant intend to treat. 3) There is no working example of such a preventive procedure in man or animal in the specification. 4) The claims rejected are drawn to clinical preventative medicine for a disease selected from the group consisting of: amyloidosis, pain, neurodegenerative diseases and neuroinflammatory diseases and are therefore physiological in nature. 5) The state of the art is that no general procedure is art-recognized for determining which patients generally will become prevented those diseases before the fact. 6) The artisan using Applicants invention would be a Board Certified physician in those diseases with an MD degree and several years of experience. Despite intensive efforts, pharmaceutical science has been unable to find a way of getting a compound to be effective for the prevention of any those diseases generally. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has actually been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs. Novo Nordisk, 42 USPQ2nd 1001, 1006. This establishes that it is not reasonable to any agent to be able to prevent any those diseases generally. That is, the skill is so low that no compound effective generally against any those diseases has ever been found let alone one that can prevent such conditions. 7) It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved", and physiological activity is generally
considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). 8) The claims broadly read on all patients, not just those undergoing therapy for the claimed diseases and on the compounds of formulas (I),(Ibis), (Ia),(Ib),(Ic)
The Examiner suggests deletion of the word “preventing” from the claims.
Claims 24-31,39-40 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 the scope of “neuroinflammatory disease ” generally is not present. The “neuroinflammatory disease ” include many autoimmune diseases where the immune system mistakenly attacks the nervous system.
Claim 24 is directed to a method of treating or preventing a disease selected from the group consisting of: amyloidosis, pain, neurodegenerative diseases and neuroinflammatory diseases in a subject, comprising administering to the subject a therapeutically effective amount of a compound of formula (I) or a pharmaceutically acceptable salt, solvate or mixtures thereof, wherein said formula (I), which include Alzheimer's disease, dementia associated with Alzheimer's disease (e.g. Pick's disease), Parkinson's disease, diffuse Lewy body disease, senile dementia, Huntington's disease, encephatis, Gilles de la Tourette syndrome, multiple sclerosis, amyotrophic lateral, sclerosis (ALS), advanced supranuclear paralysis, epilepsy, schizophrenia, depression, post-traumatic stress disorder, Lou Gehrig's disease, Creutzfeldt-Jakob disease, stroke, fragile X syndrome, multiple system atrophy (MSA), pure autonomic dysfunction with synuclein deposition (PAF), hereditary neurodegeneration with iron accumulation in the15 brn, accidental Lewy body disease in the elderly, Lewy body subtype Alzheimer's disease, Down syndrome, progressive supranuclear palsy, essential tremor with Lewy bodies, familial parkinsonism with or without dementia, tau and progranulin gene-related dementia with or without parkinsonism, bovine spongiform encephalopathy, secondary Parkinson's disease, parkinsonism resulting from neurotoxin exposure, drug-induced painsonism with a-synuclein deposition, limbic-predominant age-related TDP-43 encephalopathy (LATE), and sporadic or hereditary spinocerebellar ataxia. Preferably, said neurodegenerative or neuroinflammatory disease is a synucleinopathy. More preferably, said neurodegenerative or neuroinflammatory disease is a synucleinopathy selected from the group comprising or consisting of Parkinson's disease, diffuse Lewy25 bo disease, and multiple system atrophy.
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.
The specification falls short because data essential for treating many other neuroinflammation by administering to the subject a structure I is not described in the specification.
For the compound to be effective against neuroinflammation 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 an inflammatory disorder 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 any inflammation generally.
The scope of “autoimmune disorder”, which is a part of neuroinflammatory diseases is unclear. Consider Autism, Primary sclerosing cholangitis (PSC), Multiple Sclerosis, Idiopathic pulmonary fibrosis, Phacogenic Uveitis, adhesive capsulitis, fibromyalgia, arachnoiditis, Rosacea, Lichen sclerosus, Hidradenitis suppurativa, Multifocal Motor Neuropathy with conduction block (MMN), Polymyalgia Rheumatica, Hailey-Hailey disease (Familial benign chronic pemphigus) and Still's disease. Whether these are or are not autoimmune disorders is not known or in dispute, and indeed determining what is and what is not an autoimmune disorder has proved in numerous cases to be very troublesome. For example, there has been extensive and unresolved scientific debate over whether autism, Multiple Sclerosis and fibromyalgia are or are not autoimmune disorders. Hence, it is not known whether these diseases do or do not fall within the claim, rendering the claim indefinite.
In addition, new candidates for possible autoimmune status arise from time to time. There is some research suggesting that emphysema, and some types of schizophrenia are autoimmune. Just recently there has arisen some evidence from mice studies that OCD might well have an immune component, so OCD may, or may not, be embraced by these claims. The reverse process also occurs. For example, ankylosing spondylitis commonly appears on lists of autoimmune disorders, but recent research is pointing to it not being an autoimmune disorder, but instead an unusual response to infection.
Further complicating matters is that there is a broader and narrower understanding of what constitutes an autoimmune disorder, so that what is or is not an autoimmune disorder can depend on which concept is employed. A good example is Crohn's disease, which is certainly characterized by immune dysregulation, and commonly is labeled as an autoimmune disorder. Yet some consider it not a “true” autoimmune disorder. Similarly, whether Chronic GVHD should or should not be considered an autoimmune disorder turns to a considerable degree on the definition of an autoimmune disorder. Another example is celiac disease, which is a fairly well-understood disorder, normally listed as autoimmune, yet some do not consider it a true autoimmune disorder.
Another difficulty is the area of autoinflammatory diseases, including Familial Mediterranean fever. Although once treated as a type of autoimmune diseases, increasingly, these are not. This turns, at least to some degree, on the question of whether autoimmune disorders should be limited to the adaptive immune system, or also include disorders of the innate immune system. With this becoming accepted, then some disorders such as Schnitzler syndrome, Chronic recurrent multifocal osteomyelitis (CRMO) and Adult onset Still's disease (AOSD) are no longer be considered as autoimmune disorders, and even Behçet’s Disease might well go in this category instead of autoimmune.
The test for indefiniteness is “whether the claim delineates to a skilled artisan the bounds of the invention." SmithKline Beecham Corp. v. Apotex Corp., 74 USPQ2d 1398, 1404. Because of the ambiguities discussed above, once cannot be sure of the actual bounds of this term, what diseases it does and does not embrace, and hence the term is indefinite.
Furthermore, enablement for the treatment of a neurodegenerative disorder “by the structure (I) is not present in the specification. The specification merely mentions the use of the structure of formulas (I),(Ibis),(Ia),(Ib), (Ic), in the treatment of neurodegenerative disorder without any sufficient examples and tests.
A neurodegenerative disease is caused by the progressive loss of neurons, in the process known as neurodegeneration.[2][3] Neuronal damage may also ultimately result in their death. Neurodegenerative diseases include amyotrophic lateral sclerosis, multiple sclerosis, Parkinson's disease, Alzheimer's disease, Huntington's disease, multiple system atrophy, tauopathies, and prion diseases. Neurodegeneration can be found in the brain at many different levels of neuronal circuitry, ranging from molecular to systemic. Because there is no known way to reverse the progressive degeneration of neurons, these diseases are considered to be incurable; however research has shown that the two major contributing factors to neurodegeneration are oxidative stress and inflammation. Biomedical research has revealed many similarities between these diseases at the subcellular level, including atypical protein assemblies (like proteinopathy) and induced cell death. These similarities suggest that therapeutic advances against one neurodegenerative disease might ameliorate other diseases as well.
For example, one of the neurodegenerative disorders is called Alzheimer's disease (AD), which 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 successfully.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s)32 and 36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated clearly by Sucholeiki
Sucholeiki discloses a pharmaceutical composition which may include an effective amount of a MMP-2 and/or MMP-9 inhibiting compound of the present invention and a pharmaceutically acceptable carrier (see page 9 ,a paragraph#0144). And furthermore, it teaches the following compound:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(see page 19, example 23). These are identical with the claims.
`
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 24,28-32,36-46 are rejected under 35 U.S.C. 103 as being unpatentable over Sucholeiki (US 2011/0230452 A1) in view of Wikipeddia ( Excipient, December 2021, p 1-7).
.
Determination of the scope and content of the prior art
Sucholeiki discloses a method of treating a disease such as pain, neurodegenerative diseases and neuroinflammatory diseases in a subject by administering the following compounds of formula (XI) and pharmaceutically acceptable salts in the followings:
PNG
media_image2.png
200
400
media_image2.png
Greyscale
,(XI)
each of R1 and R2 is selected from hydrogen, halo, alkyl, hydroxy , and others.
9. The method according to claim 8 wherein the condition is selected from the group consisting of enhanced or exaggerated sensitivity to pain; acute pain; burn pain; atypical facial pain; neuropathic pain; back pain; complex regional pain syndromes I and II; arthritic pain; sports injury pain; pain related to viral infection; phantom limb pain; labor pain; cancer pain; post-chemotherapy pain; post-stroke pain; postoperative pain; physiological pain; inflanimatory pain; acute inflammatory conditions; visceral pain; neuropathic pain; neuralgia; painful diabetic neuropathy as in claim 45; traumatic nerve injury; spinal cord injury; paralysis; aging; reperfusion injury; tramna; chemical exposure or oxidative damage to tissues; wound healing; skin beautifying; and tolerance to narcotics or withdrawal from narcotics.
14. The method according to claim 13, wherein the disease is selected from the group consisting of: rhemnatoid arthritis, osteoarthritis,as in claim 44 abdominal aortic aneurysm, cancer, inflammation, atherosclerosis, multiple sclerosis, chronic obstmctive pulmonary disease, ocular diseases, neurologic diseases, psychiatric diseases, thrombosis, bacterial infection, Parkinson's disease, fatigue, tremor, diabetic retinopathy, vascular diseases of the retina, dementia, cardiomyopathy, renal tubular impairment, diabetes, psychosis, dyskinesia, pigmentary abnormalities, deafness, infianunatory and fibrotic syndromes, intestinal bowel syndrome as in claim 46 allergies, Alzheimer's disease as in claim 29-31, 39 arterial plaque formation, periodontal disease, viral infection, alcholism, dmg abuse, stroke, atherosclerosis, cardiovascular disease, haemorrhoid, and disease causing pain.
15. The method according to claim 8, wherein the condition is neuropathic pain as in claims 24 28-32,36, 38-39, 41-46(partially), .
(see pages 33- 34, claims 8-9 & 12-13 ; page 35, claims 14-15).
Also, it describes a pharmaceutical composition which may include an effective amount of a MMP-2 and/or MMP-9 inhibiting compound and a pharmaceutically acceptable carrier (see page 9, a paragraph#0141). And furthermore, it teaches the following compound:
PNG
media_image1.png
200
400
media_image1.png
Greyscale
As in claims 32 and 36 (see page 19, example 23).
Furthermore, it teaches that one affect of both acute and chronic inflammation is the sensation of pain which can be either neuropathic or nociceptive. Some common ailments associated with neuropathic pain are lower back pain, neuralgia/fibromyalgia, diabetic neuropathic pain and pain associated with multiple sclerosis. Common ailments associated with nociceptive pain are arthritic pain, particularly osteoarthritis and rheumatoid arthritis, post-operative pain, cancerrelated pain and HIV-related pain (see page 1,m a paragraph#0003).
Also, it provides MMP-2, MMP-9 and/or other metalloprotease inhibiting compounds that are useful as active ingredients in pharmaceutical compositions for treatment or prevention of metalloprotease--especially MMP-2 and/or MMP-9-mediated diseases. In addition, the prior art. It also contemplates use of such compounds in pharmaceutical compositions for oral as in claim 40 or parenteral administration, comprising one or more of the MMP-2 and/or MMP-9 inhibiting compounds (see page 4 , a paragraph#0019)
The instant invention, however, differs from the prior art in that the use of the claimed formular (Ic) for treating pain, neurodegenerative diseases and neuroinflammatory diseases in a subject and ap pharmaceutical excipient such as magnesium stearate are unspecified in the prior art.
Wikipedia teaches that magnesium stearate as in claim 37 can be used as a lubricant for a pharmaceutical expedient (see page 4 ,at the last paragraph).
Ascertainment of the difference between the prior art and the claims
The difference between the current application and the applied Sucholeiki art is that the Sucholeiki does not expressly teach the use of the claimed formular (Ic) for treating pain, neurodegenerative diseases and neuroinflammatory diseases in a subject and a pharmaceutical excipient such as magnesium stearate. The deficiencies of the Sucholeiki are partially cured by theWikipedia..
The difference between the instant application and the applied Wikipedia V
art is that the Wikipedia does not expressly teach the use of the claimed formular (Ic) for treating pain, neurodegenerative diseases and neuroinflammatory diseases in a subject. The deficiencies of Wikipedia are partially cured by the Sucholeiki.
Resolving the level of ordinary skill in the pertinent art.
Regarding claims 24,28-32,36-46, with respect to the lack of unspecifying the use of the claimed formular (Ic) for treating pain, neurodegenerative diseases and neuroinflammatory diseases in a subject, the prior art does teach the method of treating pain, neurodegenerative diseases and neuroinflammatory diseases in a subject by administering the compounds of formula (XI) ,which is very similar to the claimed formular (Ic) in terms of their corresponding chemical structures, but the only difference between the prior art compound and the claimed invention is the presence of a hydroxyl group on the tetracycline ring structure. Also, the prior at does teach the presence of the claimed compound of formula (Ic) ,which is the same compound as the compound CMT-7 :
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(see page 19, example 23).
So, if the skilled artisan in the art had desired to treat pain, neurodegenerative diseases and neuroinflammatory diseases in a subject by administering the compound CMT-7 as an alternative to compounds of formula (XI), it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Sucholeiki method so as to arrive at the claimed invention. The motivation of doing so would be to treat various patients using similar chemical structures with a minor substituent difference around the core structure.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
Sucholeiki expressly discloses the method of treating pain, neurodegenerative diseases and neuroinflammatory diseases in the subject by administering the following compounds of formula (XI) and their pharmaceutically acceptable salt thereof.
Although Sucholeiki does not expressly teach the use of the claimed formular (Ic) for treating pain, neurodegenerative diseases and neuroinflammatory diseases in a subject and the pharmaceutical excipient such as magnesium stearate, the Sucholeiki prior at does teach the presence of the claimed compound of formula (Ic) ,which is the same compound as the compound CMT-7 :
PNG
media_image1.png
200
400
media_image1.png
Greyscale
(see page 19, example 23).
Furthermore, Wikipedia does teach that magnesium stearate can be used as a lubricant for a pharmaceutical expedient (see page 4 ,at the last paragraph).
Both prior art are closely related to each other with respect to a pharmaceutical composition and its pharmaceutical excipient.
So, if the skilled artisan in the art had desired to treat pain, neurodegenerative diseases and neuroinflammatory diseases in a subject by administering a pharmaceutical composition containing compound CMT-7 as an alternative to compounds of formula (XI) and magnesium stearate lubricant as a pharmaceutical expedient, it would have been obvious to one of ordinary skill in the art at the time of the invention to be motivated to incorporate the teaching of wikipedia’s lubricant into Sucholeiki method so as to enhance the treatment.
This is because the skilled artisan in the art would expect such combined prior art to be successful and feasible as guidance shown in the prior art.
Conclusion
Claims 24-32, and 36-46 are rejected.
Claims 33-35 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 9/18/2026
Prosecution Insights