DETAILED ACTION
This office action is in response to applicant’s filing dated June 8, 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 .
Status of Claims
Claims 16-35 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed June 8, 2023. Acknowledgement is made of Applicant's cancelation of claims 1-15; and addition of new claims 16-35.
Claims 16-35 are presently under examination.
Priority
The present application is a 371 of PCT/EP2021/065693 filed on June 10, 2021, which claims benefit of US Provisional Application No. 63/037,022 filed on June 10, 2020, which claims benefit of foreign priority to EP 20179277.1; EP 20179279.3; and EP 20179239.7 filed on June 10, 2020 and EP 20180706.2 filed June 18, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on March 7, 2023 and April 21, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
Scope of Enablement
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 16-35 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 treating herpes virus comprising administering rabeximod, does not reasonably provide enablement for a method for treating any viral or bacterial infection. 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, state and predictability of the art, and relative skill of those in the art
The invention relates to a method treating viral or bacterial infection comprising administering to a subject in need thereof a composition comprising rabeximod or a pharmaceutically acceptable salt thereof. Claims 23 and 24 further narrow the disease to wherein the viral or bacterial infection leads to an acute respiratory syndrome, more specifically acute lung injury (ALI) or acute respiratory distress syndrome (ARDS). Claim 25 further narrows the viral or bacterial infection to a nosocomial infection. Claims 26-28 further narrows the viral or bacterial infection to a viral infection, more specifically corona viral infection, influenza, pneumonia, SARS, MERS, or Covid-19. Claims 29 and 30 further narrows the viral or bacterial infection to a bacterial infection, more specifically pneumonia. Claims 31-33 are directed to treating acute respiratory syndrome, more specifically acute lung injury (AL() or acute respiratory distress syndrome (ARDS), associated with a viral or bacterial infection.
Claims 14-19 and 35 further narrow the disease to those mediated by a virus, which includes all viral infections, by administering a compound of the instant formula. The specification defines the term "treatment" and "treating" as the management and care of a patient for the purpose of combating a condition, such as a disease or a disorder. The term is intended to include the full spectrum of treatments for a given condition from which the patient is suffering, such as administration of the active compound to alleviate the symptoms or complications, to delay the progression of the disease, disorder or condition, to alleviate or relief the symptoms and complications, and/or to cure or eliminate the disease, disorder or condition as well as to prevent the condition, wherein prevention is to be understood as the management and care of a patient for the purpose of combating the disease, condition, or disorder and includes
the administration of the active compounds to prevent the onset of the symptoms or complications. The treatment may either be performed in an acute or in a chronic way.
The relative skill of those in the art is high, generally that of a D.V.M. or Ph.D. The artisan using Applicant’s invention would generally be a veterinarian with a V.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).
At the time the instant application was filed, the state of the art of treating a bacterial infection as recited in claims 16 and 29 embraces treatment of the following unrelated diseases and/or infections caused by the following bacteria (without limitation, because the claim is open-ended and embraces any infection caused by any bacteria): Acute post-streptococcal glomerulonephritis (APSGN), Acute rheumatic fever, Anthrax, Botulism, Brucellosis, Campylobacter, Cholera, Diarrhea, Diphtheria, Escherichia coli, Gastroenteritis, Haemophilus influenzae type b (hib), Invasive Group A Streptococcal (iGAS) disease, Legionnaires' disease, Leptospirosis, Listeriosis, Melioidosis, Meningitis (all types), Meningococcal disease, Mycobacterium chimaera, Mycoplasma pneumoniae, Pneumococcal disease, Psittacosis, Q fever, Rheumatic heart disease, Salmonella infection (salmonellosis), Shiga toxin-producing e. coli (stec) and haemolytic uraemic syndrome (hus), Shigella infection (shigellosis), Staphylococcus aureus infection, Tetanus, Toxic shock syndrome, Trachoma, Typhoid and paratyphoid fever, Vibrio vulnificus infection, Whooping cough (pertussis), Yersiniosis, etc some of which are extremely unpredictable and difficult to treat, and not enabled by the disclosure. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects of the above listed infections/ diseases, whether or not the disease is affected by the inhibition of a certain bacteria would make a difference.
Similarly, the state of the prior art is that viral therapy, remains highly unpredictable. The state of the art establishes that rabeximod was useful for treating herpes virus as set forth in 102 rejection set forth below. However, there are many types of virus:
Adenoviruses. The adenoviruses are divided into four genera: Mastadenovirus: Bovine adenovirus A, Bovine adenovirus B, Bovine adenovirus C, Canine adenovirus, Equine adenovirus A, Equine adenovirus B, Human adenovirus A, Human adenovirus B, Human adenovirus C, Human adenovirus D, Human adenovirus E, Human adenovirus F, Murine adenovirus A, Ovine adenovirus A, Ovine adenovirus B, Porcine adenovirus A, Porcine adenovirus B, Porcine adenovirus C, and Tree shrew adenovirus; Aviadenovirus: Fowl adenovirus A, Fowl adenovirus B, Fowl adenovirus C, Fowl adenovirus D, Fowl adenovirus E, and Goose adenovirus; Atadenovirus: Bovine adenovirus D, Duck adenovirus A, Ovine adenovirus D, and Possum adenovirus; and Siadenovirus: Frog adenovirus, Turkey adenovirus A.
In addition, there are further adenovirus serotypes. Thus, while there are 6 species of human adenovirus (Human adenovirus A-F), there are 51 immunologically distinct human adenovirus serotypes that can cause human infections ranging from respiratory disease, to conjunctivitis to gastroenteritis and possibly, obesity.
Hepadnaviruses. The hepadnaviruses consist of Ground squirrel hepatitis virus, Hepatitis B virus, Woodchuck hepatitis virus, Woolly monkey hepatitis B virus, Duck hepatitis B virus and Heron hepatitis B virus.
Flavivirus. The human Flavivirus (Positive Stranded ssRNA Virus) are a diverse lot, including the Pestiviruses (such as Classical swine fever (CSF) and Bovine viral diarrhoea / Mucosal disease (BVD/MD) ), Hepatitis C, Yellow fever virus, Gadgets Gully virus, Kadam virus, Kyasanur Forest disease virus, Langat virus, Omsk hemorrhagic fever virus, Powassan virus, Royal Farm virus, Tick-borne encephalitis virus, Meaban virus, Tyuleniy virus, Aroa virus, Dengue virus, Kedougou virus, Cacipacore virus, Koutango virus, Japanese encephalitis virus, Murray Valley encephalitis virus, St. Louis encephalitis virus, Usutu virus, West Nile virus, Kunjin virus, Ntaya virus, Uganda S virus, Apoi virus, Montana myotis leukoencephalitis virus, and many, many more.
Retroviruses. The retroviruses (ssRNA RT-Viruses) fall into seven different genuses. The first is Alpharetrovirus. These include the Avian leukosis virus (ALV) (which comes in two strains), Rous sarcoma virus (RSV), which has 3 strains, Avian carcinoma Mill Hill virus 2, Avian myeloblastosis virus, Avian myelocytomatosis virus 29, Avian sarcoma virus CT10, Fujinami sarcoma virus, UR2 sarcoma virus (also known as University of Rochester virus 2 and Avian sarcoma virus UR-2), and the Y73 sarcoma virus. The second genus is the Betaretrovirus. This include the Langur virus (LNGV), Mason-Pfizer monkey virus (which comes in 3 strains), Mouse mammary tumor virus, Ovine pulmonary adenocarcinoma virus, Jaagsiekte sheep retrovirus, and the Squirrel monkey retrovirus. The third genus is the Gammaretrovirus. This includes the Feline leukemia virus, Gibbon ape leukemia virus, Guinea pig type C oncovirus, Murine leukemia virus (which exists in at least 6 strains and isolates), Porcine type C oncovirus, Finkel-Biskis-Jinkins murine sarcoma, Gardner-Arnstein feline sarcoma virus, Hardy-Zuckerman feline sarcoma virus, Harvey murine sarcoma virus, Kirsten murine sarcoma virus, Moloney murine sarcoma virus, Snyder-Theilen feline sarcoma virus, Woolly monkey sarcoma virus, Viper retrovirus, Chick syncytial virus, Reticuloendotheliosis virus, and the Trager duck spleen necrosis virus. The fourth genus is the Deltaretrovirus. This includes the Bovine leukemia virus, Primate T-lymphotropic virus 1, Human T-lymphotropic virus 1 (HTLV-1), Simian T-lymphotropic virus 1 (STLV-1), Primate T-lymphotropic virus 2 (PTLV-2), Human T-lymphotropic virus 2 (HTLV-2), Simian T-lymphotropic virus 2 (STLV-2), and the Primate T-lymphotropic virus-3. The fifth genus is the Epsilonretrovirus. These include the Walleye dermal sarcoma virus, Walleye epidermal hyperplasia virus type 1, Walleye epidermal hyperplasia virus type 2, Perch hyperplasia virus, and the Snakehead retrovirus. The sixth Genus is the Lentivirus. This includes Bovine immunodeficiency virus, Equine infectious anemia virus, Feline immunodeficiency virus, Feline immunodeficiency virus (Oma), Puma lentivirus, Caprine arthritis encephalitis virus, Visna/maedi virus (which comes in 3 strains), Human immunodeficiency virus 1 (HIV-1, which comes is many strains), HIV-2, HIV-3, and Simian immunodeficiency virus (SIV) which comes in many strains, including African green monkey, chimpanzee SIV, mandrill SIV and others. The seventh genus is the Spumavirus. This includes Bovine foamy virus, Chimpanzee foamy virus, Feline foamy virus, Simian foamy virus 1 and Simian foamy virus 3.
Filovirus. The Filoviridae (Negative Stranded ssRNA) consists of the Marburg virus (which has 6 different strains), and the Ebola virus (which has 4 different strains).
Papovirus. The papillomaviruses are divided in to 16 genera: Alphapapillomavirus (Human papillomavirus 2, Human papillomavirus 6, Human papillomavirus 7, Human papillomavirus 10, Human papillomavirus 16, Human papillomavirus 18, Human papillomavirus 26, Human papillomavirus 32, Human papillomavirus 34, Human papillomavirus 53, Human papillomavirus 54, Human papillomavirus 61, Human papillomavirus 71, Human papillomavirus cand90, Rhesus monkey papillomavirus 1); Betapapillomavirus (Human papillomavirus 5, Human papillomavirus 9, Human papillomavirus 49, Human papillomavirus cand92, Human papillomavirus cand96); Gammapapillomavirus (Human papillomavirus 4, Human papillomavirus 48, Human papillomavirus 50, Human papillomavirus 60, Human papillomavirus 88); Deltapapillomavirus (Bovine papillomavirus 1, Deer papillomavirus, European elk papillomavirus, Ovine papillomavirus 1); Epsilonpapillomavirus (Bovine papillomavirus 5); Zetapapillomavirus (Equine papillomavirus 1); Etapapillomavirus (Fringilla coelebs papillomavirus); Thetapapillomavirus (Psittacus erithacus timneh papillomavirus); Iotapapillomavirus (Mastomys natalensis papillomavirus); Kappapapillomavirus (Cottontail rabbit papillomavirus, Rabbit oral papillomavirus); Lambdapapillomavirus (Canine oral papillomavirus, (Feline papillomavirus); Mupapillomavirus (Human papillomavirus 1, Human papillomavirus 63); Nupapillomavirus (Human papillomavirus 41); Xipapillomavirus(Bovine papillomavirus 3); Omicronpapillomavirus (Phocoena spinipinnis papillomavirus); and Pipapillomavirus (Hamster oral papillomavirus).
The Coronaviruses (positive-sense single-stranded) are sorted into three groups. Group 1: Canine coronavirus, Feline coronavirus, Feline infectious peritonitis virus, Human coronavirus 229E, Porcine epidemic diarrhea virus,Transmissible gastroenteritis virus, and Human Coronavirus NL63. Group 2: Bovine coronavirus, Canine respiratory coronavirus, Human coronavirus OC43, Human enteric coronavirus, Mouse hepatitis virus, Murine hepatitis virus, Puffinosis coronavirus, Porcine hemagglutinating encephalomyelitis virus, Rat coronavirus, Sialodacryoadenitis virus, and Severe Acute Respiratory Syndrome Coronavirus (SARS). Group 3 Avian infectious bronchitis virus, Rabbit coronavirus, Infectious bronchitis virus, and Turkey coronavirus (Bluecomb disease virus).
The Picornaviruses (single stranded, positive sense) are devided into 9 genuses: 1. Enteroviruses (Bovine enterovirus, Human enterovirus A (21 types, including some coxsackie A viruses), Human enterovirus B (57 types, including assorted enteroviruses, coxsackie B viruses, echoviruses, and swine vesicular disease virus), Human enterovirus C (14 types including some coxsackie A viruses and enteroviruses), Human enterovirus D (2 types), Human enterovirus E Poliovirus (3 types), Porcine enterovirus A Porcine enterovirus B, and Simian enterovirus A(20 types).
2. Rhinoviruses (Human rhinovirus A, Human rhinovirus B). 3. Cardiovirus (Theiler's murine encephalomyellitis virus (TMEV), Vilyuisk human encephalomyelitis virus (VHEV), Theiler-like virus (TLV) of rats, Scaffold virus (SAFV-1 and SAFV-2), Columbia SK virus, Maus Elberfeld virus and Mengovirus). 4. Aphthovirus (Foot-and-mouth disease virus (in 10 forms) and Equine rhinitis A virus) 5. Hepatovirus (Hepatitis A virus, avian encephalomyelitis virus). 6. Parechovirus (Human parechovirus (HPeV) 1, HPeV-2, HPeV-3, HPeV-4, HPeV-5, HPeV-6 and Ljungan virus) 7. Erbovirus (equine rhinitis B virus (ERBV) 1, ERBV-2, ERBV-3) 8. Kobuvirus (Aichi virus, bovine kobuvirus) 9. Teschovirus (porcine teschovirus in 11 serotypes). In addition, there are numerous unassigned viruses that are normally placed with the Picronaviruses, including Acid-stable equine picornaviruses, Avian entero-like virus 2, Avian entero-like virus 3, Avian entero-like virus 4, Avian nephritis virus 3, Barramundi virus-1+, Cockatoo entero-like virus, Duck hepatitis virus 1, Duck hepatitis virus 3, Equine rhinovirus 3, Guineafowl transmissible enteritis virus, Harbour seal picorna-like virus, Sea-bass virus-1+, Sikhote-Alyn virus, Smelt virus-1+, Smelt virus-2+, Syr-Daria Valley fever virus, Taura syndrome virus of marine penaeid shrimp, Turbot virus-1, Turkey entero-like virus, Turkey hepatitis virus, Turkey pseudo enterovirus 1, and Turkey pseudo enterovirus 2.
Poxviruses are very large viruses about the size of small bacteria. They have a complex internal structure - a large double-stranded DNA genome (about 200 kbp in size) is enclosed within a "core" that is flanked by 2 "lateral bodies". The scope of pox viruses is quite extensive, in part because there are 11 genera: 1. Orthopoxvirus: Camelpox virus, Cowpox virus, Ectromelia virus, Monkeypox virus, Raccoonpox virus, Taterapox virus, Vaccinia virus (Vaccinia virus Ankara, Vaccinia virus Copenhagen, Vaccinia virus Tian Tan, Vaccinia virus WR, Buffalopox virus, Rabbitpox virus Utrecht, Cantagalo virus), Variola virus (Variola major virus Bangladesh-1975, Variola major virus India-1967, Variola virus minor Garcia-1966), Volepox virus. 2. Parapoxvirus: Bovine papular stomatitis virus, Orf virus, Parapoxvirus of red deer in New Zealand, Pseudocowpox virus, Squirrel parapoxvirus. 3. Avipoxvirus: Canarypox virus, Fowlpox virus, Juncopox virus, Mynahpox virus, Pigeonpox virus, Psittacinepox virus, Quailpox virus, Sparrowpox virus, Starlingpox virus, Turkeypox virus. 4. Capripoxvirus: Goatpox virus, Lumpy skin disease virus, Sheeppox virus. 5. Leporipoxvirus: Hare fibroma virus, Myxoma virus, Rabbit fibroma virus, Squirrel fibroma virus. 6. Suipoxvirus: Swinepox virus. 7. Molluscipoxvirus: Molluscum contagiosum virus. 8. Yatapoxvirus:Tanapox virus, Yaba monkey tumor virus. 9. Alphaentomopoxvirus: Anomala cuprea entomopoxvirus, Aphodius tasmaniae entomopoxvirus, Demodema boranensis entomopoxvirus, Dermolepida albohirtum entomopoxvirus, Figulus subleavis entomopoxvirus, Geotrupes sylvaticus entomopoxvirus, Melolontha entomopoxvirus, 10. Betaentomopoxvirus: Acrobasis zelleri entomopoxvirus 'L', Amsacta moorei entomopoxvirus 'L', Arphia conspersa entomopoxvirus 'O', Choristoneura biennis entomopoxvirus 'L', Choristoneura conflicta entomopoxvirus 'L', Choristoneura diversuma entomopoxvirus 'L', Choristoneura fumiferana entomopoxvirus ‘L’, Chorizagrotis auxiliars entomopoxvirus 'L’, Heliothis armigera entomopoxvirus ‘L’, Locusta migratoria entomopoxvirus 'O', Oedaleus senigalensis entomopoxvirus 'O', Operophtera brumata entomopoxvirus 'L', Schistocera gregaria entomopoxvirus 'O'. 11. Gammaentomopoxvirus: Aedes aegypti entomopoxvirus, Camptochironomus tentans entomopoxvirus, Chironomus attenuatus entomopoxvirus, Chironomus luridus entomopoxvirus, Chironomus plumosus entomopoxvirus, Goeldichironomus haloprasimus entomopoxvirus. There are many other poxviruses which are not assigned to a particular genus: Diachasmimorpha entomopoxvirus, Skunkpox virus, Uasin Gishu disease virus, Auzduk disease virus, Camel contagious ecthyma virus, Chamois contagious ecthyma virus, Sealpox virus, Crowpox virus, Peacockpox virus, Penguinpox virus, California harbor seal poxvirus, Cotia virus, Dolphin poxvirus, Embu virus, Grey kangaroo poxvirus, Marmosetpox virus, Molluscum-like poxvirus, Mule deer poxvirus, Nile crocodile poxvirus, Quokka poxvirus, Red kangaroo poxvirus, Salanga poxvirus, Spectacled caiman poxvirus, and Yoka poxvirus.
The paramyxoviruses (single stranded, negative sense) are divided into 7 genuses: 1. Rubulavirus: Human parainfluenza virus 2, Human parainfluenza virus 4 (includes several different strains), Mapuera virus, Mumps virus, Porcine rubulavirus, Simian virus 5, Simian virus 41. 2. Avulavirus: Avian paramyxovirus 2, Avian paramyxovirus 3, Avian paramyxovirus 4, Avian paramyxovirus 5, Avian paramyxovirus 6, Avian paramyxovirus 7, Avian paramyxovirus 8, Avian paramyxovirus 9, Newcastle disease virus. 3. Respirovirus: Bovine parainfluenza virus 3, Human parainfluenza virus 1, Human parainfluenza virus 3, Sendai virus, Simian virus 10. 4. Henipavirus: Hendra virus, Nipah virus. 5. Morbillivirus: Canine distemper virus, Cetacean morbillivirus virus, Measles virus, Peste-des-petits-ruminants virus, Phocine distemper virus, Rinderpest virus. 6. Pneumovirus: Bovine respiratory syncytial virus, Human respiratory syncytial virus, Murine pneumonia virus. 7. Metapneumovirus: Avian metapneumovirus, Human metapneumovirus. There are also some unassigned viruses in this family: Tupaia paramyxovirus, Fer-de-Lance virus, Menangle virus, Nariva virus and Tioman virus.
Even a viral agent against a family such as the Arenaviridae or the Bunyaviridae is unknown; these viruses are simply too diverse. Because of the great diversity of these viruses, which arises in part due to the wide range of mammals and birds that these infect, for a compound to work generally against these is contrary to present medical knowledge. Indeed, there is presently no agent which is effective against even a modest range of pox viruses. Currently, the only marketed antiviral that has inhibitory effects on any poxvirus is Cidofovir, which, however, as of yet has not been established as effective for the treatment of any pox disease. The vast majority of both DNA and RNA viruses have no effective antiviral treatment. Schickli et al. (Human Vaccines, Volume 5, Issue 9, pages 582-591, September 2009) state “There is currently no approved RSV vaccine, and the goal of preventing RSV-associated illness in the general population remains unmet.”
Thus, the art of developing and testing drugs, particularly for use in treating any viral or bacterial infection is extremely unpredictable.
2. The breadth of the claims
Claims 16-35 are very broad in terms of the type of diseases being treated: all types of viral and bacterial diseases are claimed to be prevented or treated with rabeximod.
3. The amount of direction or guidance provided and the presence or absence of working examples
The specification provides examples determining effect of rabeximod in patients with rheumatoid arthritis, on cytokine/chemokine release in vitro, on TLR2 and 4 activation mediated activation of macrophages in vitro/ex vivo and in vivo, on mixed lymphocytes, and on proliferative responses by lymph node cells derived from immunized rats. However, the specification does not provide any data that shows that rabeximod is useful for treating any viral or bacterial infection. Moreover, the specification does not provide any data that shows that rabeximod is useful for preventing any viral or bacterial infection.
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 rabeximod could be predictably used as prevention or treatment for all viral or bacterial infections other than herpes virus.
Determining if a particular compound will treat any particular disease state would require formulation into a dosage form, and subjecting into 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 claims16-35 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.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 16-18, 22, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Homman et al (WO 2014/140321 A1, cited in the IDS filed March 7, 2023).
Regarding claims 16 and 26, Homman teaches a method of treatment of a herpes virus infection comprising administration of a therapeutically effective amount of a compound (claim 42); wherein the compound 9-chloro-N-[2-(dimethylamino)ethyl]-2,3-dimethyl-6H-indolo[2,3-b]quinoxalin-6-acetamide (claim 9) and has the structure (page 24, lines 1-5):
PNG
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162
284
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This compound is equivalent to the instantly elected compound as evidenced by the instant specification (page 3, lines 5-15) and is hereinafter referred to as rabeximod.
Regarding claims 17 and 18, Homman teaches a compound including 9-chloro-7N-[2-(dimethylamino)ethyl]-2,3-dimethyl-6H-Indolo[2,3-b] quinoxaline-6-acetamide or a pharmaceutically acceptable salt thereof (claim 9). MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In the instant case, Homman teaches 9-chloro-7N-[2-(dimethylamino)ethyl]-2,3-dimethyl-6H-Indolo[2,3-b] quinoxaline-6-acetamide as one of 5 explicitly claimed compounds of the disclosed formula or a pharmaceutically acceptable salt thereof. Thus, one of ordinary skill in the art would at once envisage rabeximod as a free base rabeximod compound or a pharmaceutically acceptable salt of rabeximod from the disclosure of Homman.
Regarding claim 22, Homman teaches the composition of the invention may be administered orally (page 18, line 10).
Thus, claims 16-18, 22, and 26 are anticipated by the teachings of Homman.
Conclusion
Claims 16-35 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/Primary Examiner, Art Unit 1628