DETAILED ACTION
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 1-15, 46 and 47 are pending.
Sequence Requirements
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 C.F.R. § § 1.821-1.825 for the reason(s) set forth below. Pate 41, Table 7 recites SEQ ID NO:1 and SEQ ID NO:2. Neither are present in a computer readable form and sequence listing (see attached PTO-2301). Full compliance with the sequence rules is required in response to this office action.
Information Disclosure Statement
The information disclosure statement has been considered. An initialed copy is enclosed.
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.
Claims 1-15, 46 and 47 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.
The factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988). Among these factors are: 1) scope or breadth of the claims; 2) nature of the invention; 3) relative level of skill possessed by one of ordinary skill in the art; 4) state of, or the amount of knowledge in, the prior art; 5) level or degree of predictability, or a lack thereof, in the art; 6) amount of guidance or direction provided by the inventor; 7) presence or absence of working examples; and 8) quantity of experimentation required to make and use the claimed invention based upon the content of the supporting disclosure. When the above factors are weighed, it is the Examiner’s position that one skilled in the art could not practice the invention without undue experimentation. While all of the factors have been considered, only those deemed necessary to establish a prima facie case are set forth below.
Scope or breadth of the claims
The instant claims are broadly drawn to prevention of Parkinson’s Disease or treatment of symptoms comprising those set forth in claim 12.
Knowledge of the prior art and Predictability
There is no evidence of record that PD can be prevented. While the standard treatments provide for alleviation of symptoms of PD, the art does not recognize even one drug/composition that can prevent PD from emerging in any individual sporadically or genetically. The ability to identify those individuals who will get PD as to those who will not, is not set forth in the specification. The majority of PD patients do not get PD vis a vie known genetic malfunctions and as such, those individuals who are in need of prevention are not known. The ability to diagnose PD at an early stage and there is no unifying criteria for such in 2021 see Lee et al (Neuroimmunology and Neuroinflammation 8:222-44, 2021) page 223, paragraph 5. Kalia et al (The Lancet, 386:896-912, 2015) teach that the inability to diagnose PD at an early stages are complicated by difficulties in management of symptoms in later stages. No treatments that slow the neurodegenerative process are currently available (see page 896, abstract and introduction). Other than oral administration, there is no data provided that intravenous, intrathecal, intraosseous, intradermal, inhaled etc that provide for parameters reflecting treatment and certainly none that provide for prevention in the specification. No current therapeutic intervention can modify disease progression and treatment is still based on levodopa (either alone or in combination with dopamine agonists or monoamine oxidase B or catechol-O-methyltransferase inhibitors) and device-aided therapies. While oral administration has been demonstrated to improve neuronal survival, reduce inflammation, increase dopamine levels, DOPAC levels and homovanillic acid levels, none of the plethora of symptoms set forth in claim 12 have been demonstrated to be reduced or ameliorated in the animal model such that the skilled artisan would readily appreciate treatment or prevention thereof. Lee et al (Neuroimmunology and Neuroinflammation 8:222-44, 2021; page 227, third paragraph) teach that the exact cause of Parkinson’s disease has not been identified and there is no known cure, so treatments seek to manage symptoms rather that prevent or slow the progression of the disease. Lee et al also teach that there are no-disease modifying or neuroprotective therapies available to slow the progression on the disease. Finally, PD is a disease that affects multiple neural pathways in the brain not just motor pathways and different patients respond to drugs differently as a result of different disease subtypes and that treatment is based upon individual responsiveness and symptoms. The existing treatment remains empiric based upon the response or lack thereof by the patient demonstrating the unpredictability of treatment in this disease.
Guidance provided by inventor/working examples
The specification teaches that: ART24 can protect dopaminergic neurons and reduce inflammatory markers in the striatum, in a MPTP mouse model of PD (ex.1-2); ART24 has a neuroprotective effect on LPS-induced damages in a culture of mesencephalic cells (ex.5); ART24 and ART12 improve motor movement in a MTPP zebrafish model of PD (ex.6 and 9); and ART24 and ART12 increase dopamine metabolite HVA in striatum and increase Parkinson's gene expression (KEGG grouping) in striatal and colonic tissue, in a MPTP mouse model of PD and (ex.7) and ART24 improves rescue of dopaminergic neurons in a α-synuclein zebrafish model of PD (ex.8). However, none of these examples demonstrate that in any in vitro or in vivo model, Parkinson’s Disease can be prevented by administering ART24 and/or ART12 by any route. The specification does not provide when before the development of PD that ART24 and/or ART12 need to be administered, the route of administration, the duration/time period of administration and the amount that needs to be administered in order to prevent PD. As such, given the lack of evidence for prevention of PD in the specification and the lack of demonstration of effective reduction or amelioration of one or more of the symptoms set forth in claim 12, the specification is not enabled for such as it would require extensive and undue experimentation to determine such.
Quantity of experimentation
No animal models exist for evaluating many of the claimed symptoms and the skilled artisan would have to develop such and then test ART24 and ART12 for effectiveness. This experimentation would require ingenuity beyond the skill of the ordinary artisan. Given the state of the art that prevention is not possible at this time, that the animal models do not measure the symptoms of claim 12, that prevention has not been demonstrated by the specification, that direction and guidance for prevention has not been set forth, nor how to identify those subjects in need prior to the development of PD.
In light of the foregoing factors, the evidence as a whole suggests that the specification, in light of the level of knowledge in the art, does not enable one of ordinary skill to make or use the invention over the full scope of the instant claims without undue experimentation. Consequently, the claims are prima facie non-enabled. The claims are not enabled for prevention of Parkinson’s Disease (PD) or treatment of the symptoms set forth in claim 12.
In applications directed to inventions in arts but where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA 1938). In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.
Additionally, the specification lacks complete deposit information for the deposit of bacteria strains ART24 and ART12. Because it is not clear that cell lines possessing the properties of the bacterial strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of ART24 and/or ART12, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production of the bacterial strains recited in the claims is required. Without a publicly available deposit of the above cell line, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed. Exact replication of the bacterial strains is an unpredictable event.
Applicant's referral to the deposit of the bacteria strains on page 45, paragraphs [173-175] of the specification is an insufficient assurance that all required deposits have been made and all the conditions of 37 CFR §1.801-1.809 have been met. Since the deposits have been made under the provisions of the Budapest Treaty, filing of an affidavit or declaration by applicant or assignees or a statement by an attorney of record who has authority and control over the conditions of deposit over his or her signature and registration number stating that the deposit has been accepted by an International Depository Authority under the provisions of the Budapest Treaty, that all restrictions upon public access to the deposit will be irrevocably removed upon the grant of a patent on this application and that the deposit will be replaced if viable samples cannot be dispensed by the depository is required. This requirement is necessary when deposits are made under the provisions of the Budapest Treaty as the Treaty leaves this specific matter to the discretion of each State. Applicant's attention is directed to In re Lundack, 773 F.2d. 1216, 227 USPQ 90 (CAFC 1985) and 37 CFR §1.801-1.809 for further information concerning deposit practice.
Free of the Prior Art
The closest prior art is Do-Youn et al (Foods, 10(2):221, 2021) of record on the PTOL-1449. However, Do-Youn et al do point to the use of specific alternative strain of Bacillus amyloliquefaciens and ART24 and/or ART12, in particular. While ART12 and/or ART were known for the treatment of digestive diseases and incorporation into food stuffs, the art does not suggest any effect of the ART24/ART12 strains on neurons or in Parkinson’s Disease.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Patricia Duffy whose telephone number is (571)272-0855. The examiner can normally be reached 8:00 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached at 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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