DETAILED ACTION
This action is in response to Applicant’s submission dated March 9, 2026, in which Applicant selected a species for search purposes only. Once this species was not found in the art, the full scope of the invention was searched.
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 .
Information Disclosure Statement
The references contained in the IDS dated November 28, 2023 are made of record.
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.
Claims 22-29 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claims contain 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 use the invention. "When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation". MPEP 2164.01(c). 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. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk, 42 USPQ2d 1001.
As the Supreme Court said in Brenner v. Manson, 148 USPQ at 696: “a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” As U.S. Court of Customs and Patent Appeals stated In re Diedrich 138 USPQ at 130, quoting with approval from the decision of the board: “We do not believe that it was the intention of the statutes to require the Patent Office, the courts, or the public to play the sort of guessing game that might be involved if an applicant could satisfy the requirements of the statutes by indicating the usefulness of a claimed compound in terms of possible use so general as to be meaningless and then, after his research or that of his competitors has definitely ascertained an actual use for the compound, adducing evidence intended to show that a particular specific use would have been obvious to men skilled in the particular art to which this use relates.”
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.” These factors include 1) the breadth of the claims, 2) the nature of the invention, 3) the state of the prior art, 4) the level of one of ordinary skill, 5) the level of predictability in the art, 6) the amount of direction provided by the inventor, 7) the existence of working examples, and 8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The nature of the invention:
The nature of the present invention are various methods of treating fungal infections via administration to the subject at risk of acquiring or having a fungal infection. The instant application; however, does not provide any additional evidence that the presently claimed compounds are effective against fungal infection as presently claimed. The person skilled in the art only can put the teaching into practice and achieve the intended level of success if he or she has information of a causal relationship between the use of the substance and therapeutic effect induced by its application of the human body. The presentation of this relationship is thus seen as a kind of disclosure for the application of the substance for the desired purpose.
The state of the prior art:
This must be described and explained in a manner comprehensible to the person skilled in the art, such as on the basis of experimental data, possibly in conjunction with findings of the prior art, which show that the desired therapeutic effect can be achieved by administration of the substance. If mere instructions are given as how to use a known substance X for the treatment of disease Y, the person skilled in the medicinal chemistry arts is only faced with speculation because the concept underlying the invention and justifying protection showing that the substance objectively has a certain useful and reproducible therapeutic activity has not been provided.
The predictability in the art:
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 claimed invention is highly unpredictable since one skilled in the art would not necessarily recognize, with regards to therapeutic effects, whether or not compounds of Formula I would be useful in treating a fungal infection.
Amount of guidance/working examples:
Here, the present application merely speculates that compounds of Formula I would be useful in treating a fungal infection. No where in the METHODS OF TREATING section of the specification pages 15-21 does it show that compounds of Formula I would be useful in treating a fungal infection. The prose is simply generic disclosure stating the intention to do so, but with absolutely no data sufficiently showing a nexus between compounds of Formula I and the treatment of a fungal infection. In addition, this application lacks a Drawings section altogether.
The quantity of undue experimentation needed:
Since the guidance and teaching provided by the specification is insufficient for methods for treating fungal infected patients using an effective amount of compounds of Formula I, one of ordinary skill in the art, even with a high level of skill, is unable to use compounds of Formula I for treating fungal infected patients as claimed without undue experimentation. An application claiming protection for a medical use in such an early stage of drug development and that does not have any data concerning the therapeutic effects of the substance, therefore, represents an incomplete disclosure because the use of successfully treating a specific disease, in this case fungal infected patients, is insufficient and thus not enabled.
The level of the skill in the art:
The level of skill in the art is high. Due to the unpredictability in the pharmaceutical art; however, 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 diseases or diseases would benefit from this activity.
Taking all of the above factors into consideration, it is not seen how one of ordinary skill in the art would be able to make and use compounds of Formula I in methods of treating fungal infected patients without undue experimentation.
Claim Rejections - 35 USC § 112
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(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1-2, 4, and 6 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) because the structure of Formula I contains X1 to X3 and R1 to R4; however, in the prose defining each, there are definitions for only X1 to X4 and only R1 to R3. Correction is required.
Claims 2, 4, and 6 are rejected under 35 U.S.C. 112(d), as it lacks antecedent basis because they refer to C4, C5, C6, or C7 as heterocycle or heteroaryl; however, those are not options for the definitions of C4, C5, C6, or C7 in claim 1. Correction is required.
Claim Objections
Claims 8, 10, 12-15, and 20-21 are objected to as being dependent upon rejected independent claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claims and any intervening claims.
Closest Prior Art
The closest prior art is Blanco-Pilado, et al., U.S. Patent No. 7,608,629; which teaches a compound having 5HT1F receptor modulatory activity (col. 147, lines 34-48), analogous to Formula I, wherein the CR2R3-(oxygen-containing heteroring) is replaced by N-menthylpiperidine; and wherein X1, X2, X3 and X4 are each CH; R1 is hydrogen and Q is a sigma bond (column 65, lines 1-10, Example 23), but does not teach a compound having the CR2R3-(oxygen-containing heteroring) of Formula I. Therefore, the claims are free of prior art.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) toll-free at 866-217-9197. If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932
Prosecution Insights