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 the Application
Applicant's election with traverse of Group I, drawn to a method of treating or preventing a neurodegenerative disease by administering a compound able to increase OPC differentiation to oligodendrocyte and/or to increase remyelination and/or to preserve neuronal viability and morphology, and the species, multiple sclerosis and bavisant, in the reply filed on 3/12/26 is acknowledged. The traversal is on the grounds that the prior art does not teach the claimed compounds having the claimed specific functional properties. This is not found persuasive because the claimed specific functional properties are inherent to the compounds, therefore not considered a special technical feature that makes a contribution over the prior art. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-6, 8-12, 16 are pending. Claims 10-12 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 3 and 5 have been withdrawn from further consideration as being drawn to a non-elected species. Claims 1-2, 4, 6, 8-9, 16 are examined herein insofar as they read on the elected invention and species.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 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 1-6, 8-9, 16 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 specification, while being enabled for the method of treating a neurodegenerative disease by administering a compound able to increase OPC differentiation to oligodendrocyte and/or to increase remyelination and/or to preserve neuronal viability and morphology, does not reasonably provide enablement for preventing. The specification does not enable any person skilled in the art to which it pertains to practice the invention commensurate in scope with these claims.
The instant specification fails to provide information that would allow the skilled artisan to fully practice the instant invention without undue experimentation. Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the 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: (1) the nature of the invention; (2) the state of the prior art; (3) the breadth of the claims; (4) the amount of direction or guidance presented; (5) the predictability or unpredictability of the art; (6) the relative skill of those in the art; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
(1) The Nature of the Invention: The rejected claims are drawn to an invention which pertains to a method of preventing and treating a neurodegenerative disease by administering a compound able to increase OPC differentiation to oligodendrocyte and/or to increase remyelination and/or to preserve neuronal viability and morphology.
(2) State of the Prior Art: The state of the art regarding treating a neurodegenerative disease is relatively high, however the state of the art for the prevention of a neurodegenerative disease is non-existent.
(3) Breadth of Claims: The complex nature of the subject matter of this invention is greatly exacerbated by the breadth of the claims. The claims encompass the prevention, inhibition, and treatment of any and all neurodegenerative diseases.
(4) Guidance of the Specification: The guidance of the specification as to the prevention of a neurodegenerative disease is completely lacking. The specification discloses preventing the onset of a neurodegenerative disease. However, the specification fails to mention how one is able to determine whether the onset of a neurodegenerative disease in a subject would have occurred in the absence of treatment, thus being unable to confirm that prevention has indeed taken place. Moreover, the specification fails to mention the complete prevention or cessation of a neurodegenerative disease once the onset of preclinically evident stage is determined.
(5) The Predictability or Unpredictability of the Art: The invention is directed to a method of treating, inhibiting, and preventing a neurodegenerative disease. The specification does not disclose how one of ordinary skill in the art at the time of the invention would be able to prevent a neurodegenerative disease, nor does the prior art reveal any type of prevention associated with a neurodegenerative disease.
(6) The Relative Skill of those in the Art: One of ordinary skill in the art does not know how to prevent a neurodegenerative disease. Moreover, one is unable to determine whether a subject will ever develop a neurodegenerative disease should this subject be administered a compound able to increase OPC differentiation to oligodendrocyte and/or to increase remyelination and/or to preserve neuronal viability and morphology.
(7) Working Examples: The specification does not give any data for the prevention of a neurodegenerative disease.
(8) The Quantity of Experimentation Necessary: The specification fails to provide support for the prevention of a neurodegenerative disease by administering a compound able to increase OPC differentiation to oligodendrocyte and/or to increase remyelination and/or to preserve neuronal viability and morphology. Nor does it provide information to practice the claimed invention, absent undue experimentation. Genetech, 108 F. 3d at 1366 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable.”
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)(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 1-6, 8-9, 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tait et al. (WO 2019/195742).
Tait et al. teach a method of treating a demyelination disease or disorder in a subject in need thereof by administering a muscarinic acetylcholine receptor (MAChR) antagonist/inverse agonist/partial agonist and a histamine H3 receptor antagonist/inverse agonist/partial agonist (claim 4), wherein the disease is multiple sclerosis (claims 6-7) and the histamine H3 receptor antagonist/inverse agonist/partial agonist is bavisant (claims 8-9, 16, 18) in a concentration of 100 nM to 100 mM (paragraph 00054). This method will increase proliferation of oligodendrocyte progenitor cells (OPCs) into mature, myelinating oligodendrocytes and treat demyelination disorders that reduce neuronal function (abstract and paragraph 0081).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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