Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Applicant’s arguments, filed 5/11/2026, have been fully considered but they are not deemed to be (fully) persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
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 1-2 and 7-19 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. Applicant's attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set forth eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: The nature of the invention; the state of the prior art; the relative skill of those in the art; the predictability or unpredictability of the art; the breadth of the claims; the amount of direction or guidance presented; the presence or absence of working examples; and the quantity of experimentation necessary. Nature of the invention: The claims recite a method of treating Parkinson’s disease. In the application, the an EAE animal model is used for multiple sclerosis, however, the EAE animal model is not used to model Parkinson's disease. The presence or absence of working examples: The specification provides no working examples with the EAE animal model supporting the treatment of Parkinsons’ disease. The quantity of experimentation necessary: In order to practice the invention, one skilled in the art would undertake a novel and extensive research program into methods of treating Parkinson’s disease and nervous system disorders. Because this research would have to be exhaustive, it would constitute an undue and unpredictable experimental burden. Therefore, in view of the Wands factors, as discussed above, particularly the breadth of the claims, Applicants fail to provide information sufficient to practice the claimed invention for the treatment of Parkinson's disease and nervous system disorders. The predictability or unpredictability of the art: Animal models are well known in the art, however, they are tailored to model specific diseases as various diseases have differing mechanisms of action. Further, there is not one model that can be used for nervous system disorders, much less an enabling disclosure for treatment of Parkinson’s disease by the claimed methods.
Applicant’s arguments have been fully considered but are not found persuasive. Regarding applicant’s remarks that the application teaches that Parkinson’s Disease is a treatable disease, the examiner’s response is that the examiner acknowledges that Parkinson’s Disease is a treatable disease, but the issue at hand is whether or not the application provides an enabling disclosure to carry out the presently claimed method of treating Parkinson’s Disease. Regarding applicant’s argument that the breadth of the claims are precisely delimited by the enabled composition, applicant has made no showing of this, but relies on reasoning that as the claims are “narrow and specific,” that a method of treating Parkinsons disease by the method is enabled. Enablement isn’t shown by demonstrating that the claims are narrow, enablement is shown by demonstrating that a patent application describe an invention in such clear, concise, and exact terms that a person skilled in that art can make and use the claimed invention without "undue experimentation". Although the scope of the claims are a consideration, other factors include the level of predictability in the art and the existence of working or prophetic examples in the application must enable the artisan to carry out the invention without undue experimentation. Regarding applicant’s argument that the claimed composition is fully characterized by a known route, this is not persuasive as no where in the application is the composition administered by a known route in treatment of Parkinson’s Disease, and nowhere in the application is there a showing that by administering the composition by the known route reference by applicant would treat Parkinson’s Disease, which is very difficult disease to treat. Parkinson's disease is very difficult to treat because it is a progressive, irreversible neurodegenerative disorder rather than a static illness. While treatments exist to manage symptoms, scientists cannot stop or reverse the condition for several primary reasons: The Blood-Brain Barrier (BBB): The brain has a highly protective natural filter that blocks dangerous toxins, but it also blocks most synthetic medications from ever reaching the brain, In Parkinson's, nerve cells in the substantia nigra die off and deplete the brain's dopamine supply. Medical science cannot currently regenerate lost or damaged brain tissue, In Parkinson's, nerve cells in the substantia nigra die off and deplete the brain's dopamine supply. Medical science cannot currently regenerate lost or damaged brain tissue, Healthcare professionals still do not know the exact cause of Parkinson's, which makes developing a targeted cure immensely difficult, the disease manifests differently in every person, presenting over 40 diverse motor and non-motor symptoms. Regarding applicant’s argument that as neuroinflammation is associated with Parkinson’s disease, that the artisan would understand that a MIF/IL-6 modulation in the EAE model would necessarily treat Parkinson’s Disease, the examiner’s response is that there is no demonstration of this in the application and Parkinson’s is difficult condition to treat. Regarding appicant’s argument that “the specification itself provides the compositional, mechanistic, and dosing bridge between the demonstrated indications and the claimed indication,” the examiner’s response is that there is n o compositional, mechanistic, and doing bridge taught in the application for the treatment of Parkinson’s Disease. Regarding applicant’s argument that the EAE (MS) and (CIA (arthritis) working models would be understood to provide sufficient enablement for treatment of Parkinson’s Disease, the examiner’s response is that a method that treats MS and CIA does not in and of itself provide enablement for Parkinson’s Disease, which is not he same condition as MS and CIA, and which is very difficult to treat. The artisan would recognize still further problems not addressed in the application, such as how to carry out a treatment of Parkinsons Disease using a suspension comprising zero chloride ions, which is highly challenging in clinical setting because formulating and storing a chloride-free liquid introduces sever contamination risks because the saline and many common pharmaceutical buffers contain chloride.
Notes and Comments
The claims are free from the prior art. The closest prior art is US 10,449,217 (IDS filed 4/9/2021), which teaches a suspension comprising: a.) water; b.) at least one processing enhancer comprising at least one material selected from the group consisting of sodium bicarbonate, sodium carbonate, potassium bicarbonate, potassium carbonate, trisodium phosphate, disodium phosphate, monosodium phosphate, and potassium phosphates; c.) gold nanocrystals suspended in said water forming a suspension, wherein said gold nanocrystals: i.) having surfaces that do not have organic chemical constituents adhered or attached to said surfaces; ii.) having a mode particle size of less than about 50 nm; iii.) are present in said suspension at a concentration of at least 2 ppm by weight per volume; and d.) said suspension having a pH of between about 5 to about 9.5, said gold nanocrystals having a zeta potential of about −20 mV or lower at a temperature of about 25° C., said zeta potential being determined by measuring the electrophoretic mobility of the gold nanocrystals in the suspension, and the suspension does not contain chloride ions (claim 1). However, the prior art fails to teach or fairly suggest the present method of administering the invention to treat Parkinson’s Disease.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/ Primary Examiner, Art Unit 1618
June 13, 2026
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