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 .
Claims 1-11, 23 and 24 are pending in the instant application. Claims 1-11, 23 and 24 are rejected.
Information Disclosure Statements
The information disclosure statements filed on March 21, 2024 and June 26, 2024 have been considered and signed copies of form 1449 are enclosed herewith.
Drawings
The drawings are objected to because the font on several of the figures is difficult to read (i.e., see Figures 1 and 2). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11, 23 and 24, and the species buntanetap in the response filed on April 30, 2026 is acknowledged. Upon further search and consideration, however, the election of species requirement has been withdrawn (i.e., the full scope of the subject matter of claims 1-11, 23 and 24 has been searched and examined in its entirety). The restriction requirement (between groups) is still deemed proper and hereby 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 1-11, 23 and 24 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 for treating, inhibiting, reducing, slowing, or delaying symptoms of autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, or schizophrenia comprising administering to a human in need thereof a therapeutically effective amount of buntanetap or a pharmaceutically acceptable salt thereof does not reasonably provide enablement for a method for treating, inhibiting, reducing, slowing, or delaying symptoms of autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, or schizophrenia comprising administering to a human in need thereof a therapeutically amount of a compound selected from the group consisting of Formula (I), Formula (II) and Formula (III) or pharmaceutically acceptable salts thereof (i.e., other than buntanetap) nor does it reasonably provide enablement for a method for treating, inhibiting, reducing, slowing, or delaying symptoms of any mental illness (i.e., other than autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, or schizophrenia), comprising administering to a human in need thereof a therapeutically effective amount of a compound selected from the group consisting of Formula (I), Formula (II) and Formula (III) or pharmaceutically acceptable salts thereof (i.e., including buntanetap). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include: nature of the invention, breadth of the claims, guidance of the
specification, the existence of working examples, state of the art, predictability of the art
and the amount of experimentation necessary. All of the Wands factors have been
considered with regard to the instant claims, with the most relevant factors discussed
below.
The state of the prior art and the predictability or lack thereof in the art
The state of the prior art is that the pharmacological art involves screening in
vitro and in vivo to determine which compounds exhibit the desired pharmacological
activities (i.e., what compounds can treat which specific disease, disorder or
condition by what mechanism). There is no absolute predictability even in view of the
seemingly high level of skill in the art. The existence of these obstacles establishes that
the contemporary knowledge in the art would prevent one of ordinary skill in the art from
accepting any therapeutic regimen on its face.
The instantly claimed invention is highly unpredictable as discussed below: It is
noted that the pharmaceutical art is unpredictable, requiring each embodiment to be
individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 166 USPQ 18
(CCPA 1970) indicates that the more unpredictable an area is, the more specific
enablement is necessary in order to satisfy the statue. In the instant case, the claimed
invention is highly unpredictable since one skilled in the art would recognize that in
regards to therapeutic effects, whether or not the symptoms of a mental illness are affected by the administration of a compound selected from the group consisting of Formula (I), Formula (II) and Formula (III) or pharmaceutically acceptable salts thereof would make a difference.
With regards to treating, inhibiting, reducing, slowing, or delaying symptoms of a mental illness, this method could include many unrelated diseases or conditions (i.e., many of which have a different cause and, therefore, require a different treatment). There is not one class of compounds, let alone one compound, which can treat all of the diseases or conditions which could be included in the broad class of a mental illness.
For example, the specification describes “mental illness” as including neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, depressive disorders, anxiety disorders, obsessive-compulsive and related disorders, trauma and stress-related disorders, dissociative disorders, somatic symptom and related disorders, feeding and eating disorders, elimination disorders, sleep-wake disorders, etc. See [0085]-[00103].
However, it is also disclosed in the specification that five major metal illnesses – autism, attention deficient-hyperactively disorder, bipolar disorder, major depressive disorder, and schizophrenia – appear to share some commonalities: they all show dysfunctional nerve cell transmission and communication, dysregulation of Abeta protein synthesis similar to neurodegenerative diseases, and they share genetic risk factors, according to an examination of genetic data from more than 60,000 people worldwide. See [0005].
Hence, in the absence of a showing of correlation between all the mental illnesses claimed as capable of treatment through the administration of a compound selected from the group consisting of Formula (I), Formula (II) and Formula (III) or pharmaceutically acceptable salts thereof, one of skill in the art is unable to fully predict possible results from the administration of a compound selected from the group consisting of Formula (I), Formula (II) and Formula (III) or pharmaceutically acceptable salts thereof thereof due to the unpredictability.
The amount of direction or guidance present and the presence or absence of
working examples
A disclosure should contain representative examples which provide reasonable
assurance to one skilled in the art that the compounds which fall within the scope of a
claim will possess the alleged activity. The only direction or guidance present in the instant specification is a non-patent literation citation which discloses the commonalities of autism, attention deficient-hyperactively disorder, bipolar disorder, major depressive disorder, and schizophrenia (see [0005]), the listing of mental illnesses Applicant considers as treatable by the administration of a compound selected from the group consisting of Formula (I), Formula (II) and Formula (III) or pharmaceutically acceptable salts thereof and in vitro and in vivo assays which only involve buntanetap (see Examples 1-9 on pages 48-60). However, the specification does not contain evidentiary support that buntanetap would be able to treat the plethora of diseases or conditions which could be considered a mental illness (see above) nor does it support using a compound other than buntanetap. Furthermore, there are no working examples to support the treatment of the instantly claimed mental illnesses besides those which involve buntanetap.
Applicant has not provided any competent evidence or disclosed tests that are
highly predictive for the pharmaceutical use of the instant compounds and
pharmacological activity in general is a very unpredictable area. Note that in cases
involving physiological activity such as the instant case, "the scope of enablement
obviously varies inversely with the degree of unpredictability of the factors involved."
See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The level of skill in the art
The level of skill in the art is high. However, due to the unpredictability in the
pharmaceutical art, it is noted that each embodiment of the invention is required to be
individually assessed for physiological activity by in vitro and in vivo screening to
determine which compounds exhibit the desired pharmacological activity and which
mental illnesses would benefit from this activity.
Thus, the specification fails to provide sufficient support of the broad use of the
compounds of the instant claims for the treatment of the various claimed
mental illnesses, as a result necessitating one of skill to perform an exhaustive search for which mental illnesses can be treated by what compounds of the instant claims in order to practice the claimed invention. Only several of the claimed mental illnesses are discussed here to make the point of an insufficient disclosure, it does not mean that the other mental illnesses meet the enablement requirements.
The quantity of experimentation needed
The quantity of experimentation needed is undue experimentation. One of skill in
the art would need to determine what specific mental illnesses are benefited by the
administration of the compounds of the instant claims and would furthermore have to
determine which of the claimed compounds would provide treatment of which mental illnesses.
Factors such as "sufficient working examples", "the level of skill in the art" and
"predictability", etc. have been demonstrated to be sufficiently lacking in the instantly
claimed method. In view of the chemical nature of the invention and the lack of working
examples regarding the activity of the claimed compounds, one having ordinary skill in
the art would have to undergo an undue amount of experimentation to use the invention
commensurate in scope with the claims.
Genentech Inc. v. Novo Nordisk A/S (CA FC) 42 USPQ2d 1001, 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".
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed
above, to practice the claimed invention herein, a person of skill in the art would have to
engage in undue experimentation to test which specific mental illnesses can be treated by the compounds encompassed in the instant claims, with no assurance of success.
This rejection can be overcome by amending the claims to be drawn to a method for treating, inhibiting, reducing, slowing, or delaying symptoms of autism, attention deficit-hyperactivity disorder, bipolar disorder, major depressive disorder, or schizophrenia comprising administering to a human in need thereof a therapeutically effective amount of buntanetap or a pharmaceutically acceptable salt thereof.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 5, 6, 10, 23, and 24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-3, the phrases "substantially pure (-)-enantiomer" and “substantially pure (+)-enantiomer” are relative terms which renders the claims indefinite. Specifically, the word “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Appropriate correction is required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ANN VAJDA whose telephone number is (571)270-5232. The examiner can normally be reached Mon-Fri 6:00-4:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTIN A VAJDA/Primary Examiner, Art Unit 1622
Prosecution Insights