Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 8/5/2025 is acknowledged. The traversal is on the ground(s) that there would be no undue search burden to examine the groups together. This is not found persuasive because there would be an undue search burden to examine the groups together for the reasons set forth on pages 5-6 of the restriction requirement, which applicant has not addressed except for a conclusory statement that there is no search burden..
The requirement is still deemed proper and is therefore made FINAL.
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.
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
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
November 15, 2025