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 .
DETAILED ACTION
Claims 1-5, 8-11, 21-22, 28, 30-35, 39-42, 48-58 and 60 are currently pending in the instant application. Applicants have cancelled claim 2, 4, 8, 9, 21, 28 and 30 and amended claims 1, 5, 9, 11, 22, 32-35, 41, 42, 51 and 53 in an amendment filed on May 6, 2026. Claims 53-58 and 60 are rejected, claim 32 is objected and claims 1-5, 8-11, 21-22, 28, 30-31, 33-35, 39-42 and 48-52 are considered allowable in this Office Action.
I. Response to Arguments/Remarks
Applicants’ amendment, filed on May 6, 2026, has overcome the rejection of claims 1-5, 8, 9, 11, 22, 28, 30, 31, 32, 39, 50 and 52 under 35 USC 102(a)(1) as being anticipated by PubChem 67394638; the rejection of claims 1, 9, 11, 22, 30, 31, 33, 49, 50 and 52 under 35 USC 102(a)(1) as being anticipated by RN 2171160-05-5; the rejection of claims 1, 3, 5, 8, 9, 11, 22, 28, 30, 31, 32, 49, 50 and 52 under 35 USC 102(a)(1) as being anticipated by Magne, et al.; 1-5, 8, 9, 11, 22, 28, 30, 31, 32, 49, 50 and 52 under 35 USC 102(a)(1) as being anticipated by RN 848764-74-9; the rejection of claims 1-5, 8-11, 22, 28, 30, 31, 49, 50 and 52 under 35 USC 102(a)(1) as being anticipated by RN 2107983-01-5; the rejection of claim 22 under 35 USC 112(b) as being indefinite for broad limitations then narrow limitations being present; the rejection of claim 28 under 35 USC 112(b) as being indefinite for broad limitations then narrow limitation being present; the rejection of claims 53-58 and 60 under 35 USC 112(b) as being indefinite for not defining the structure of the compounds 1-218 listed in the claim; and the objection of claim 21 as being dependent on a rejected based claim. The above rejections and objection have been withdrawn.
II. Rejection(s)
Claim Rejections - 35 USC § 112, first paragraph
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 53-58 and 60 are rejected under 35 U.S.C. 112 (a), because the specification, while being enabling for a method of treating or ameliorating a psychiatric disease or disorder does not reasonably provide enablement for a method of preventing a psychiatric disease or disorder. 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 the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01 (a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or lack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case
The nature of the invention
The nature of the invention is a method of treating or ameliorating a psychiatric disease or disorder. Support for the intended use is in vitro data for 5-HT2A receptor binding studies, serotonin receptor functional assay; head twitch response studies, etc. on pages 201-233 of the specification.
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 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 instant 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 statute. In the instant case, the instant claimed invention is highly unpredictable since one skilled in the art would recognize that in regards to therapeutic effects of any condition mediated by 5-HT2 receptors, whether or not the condition is affected by the instant compounds’ activity would make a difference.
For example, Applicants’ claims are drawn to a method of preventing OCD. OCD is a pattern of unwanted thoughts and fears known as obsessions. The obsessions lead to repetitive behaviors called compulsions. OCD compulsions are repetitive behaviors that a person feels driven to do. The repetitive behaviors or mental acts are meant to reduce anxiety related to the obsessions or prevent something bad from happening. But taking part in the compulsions may offer only limited relief from the anxiety. OCD usually begins in the teen or young adult years but it can start in childhood. OCD is a lifelong disorder, can have mild to moderate symptoms or be so severe and time-consuming that it becomes disabling. There is no sure way to prevent OCD but getting treatment as soon as possible may help it from getting worse (See https://www.mayoclinic.org/diseases-conditions/obsessive-compulsive-disorder/symptoms-causes/syc-20354432)
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 amount of direction or guidance present and the presence or absence of working examples
The only direction or guidance present in the instant specification is minimal for preventing any psychiatric diseases or disorders. There are no working examples present for preventing any of the diseases or disorders embraced by the claims.
Test assays and procedure are provided in the specification such as in vitro data for 5-HT2A receptor binding studies, serotonin receptor functional assay; head twitch response studies, etc. on pages 201-233.
Receptor activity is generally unpredictable and the data provided is insufficient for one of ordinary skill in the art in order to extrapolate to the other compounds of the claims. It is inconceivable as to how the claimed compounds can treat the extremely difficult diseases embraced by the instant claims.
Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use of the instant compounds. 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 breadth of the claims
The breadth of the claims is a method of treating or preventing or ameliorating a psychiatric disease or disorder
The quantity of experimentation needed and the level of the skill in the art
The quantity of experimentation needed is undue experimentation. One of skill in the art would need to determine what diseases would be benefited by the effects of inhibiting or activating 5-HT2 receptors and would furthermore then have to determine which of the claimed compounds in the instant invention would provide treatment or prevention of the diseases.
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 or in vivo screening to determine which compounds exhibit the desired pharmacological activity and which diseases would benefit from this activity.
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 diseases can be treated by the compound encompassed in the instant claims, with no assurance of success.
This rejection can be overcome, for example, by amending the claim to read on the subject matter that Applicants' specification are enabled for as indicated above.
III. Objections
Claim Objections
Claim 32 is objected to because of the following informalities: claim 32 should have the term “and” in between the last two structure listed in the claim.
IV. Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Shawquia Jackson whose telephone number is (571)272-9043. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan can be reached on (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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/SHAWQUIA JACKSON/Primary Examiner, Art Unit 1626
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