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
Filing Receipt and Priority
The filing receipt mailed 05/10/2024 states that the instant application is a CON of U.S. PAT 11,957,687 (formerly application 17/622,454), which is a 371 of PCT/US20/40542, which claims benefit of provisional application 62/869,752, filed 07/02/2019.
The provisional application supports the instant application. Therefore, the effective filing date is 07/02/2019.
Information Disclosure Statement
The information disclosure statement submitted 02/08/2024 has been considered.
Restriction/Species Election
The election of the following Group and species is acknowledged. Applicant has elected without traverse Group I, claims 48-52, 54, 58-60, and 62. Applicant has elected without traverse the compound of the following formula.
PNG
media_image1.png
126
184
media_image1.png
Greyscale
At examiner’s discretion, search and examination has been broadened to the entire scope of compounds of formula I as recited in claims 48 and 49.
Claims 67, 69-76 are withdrawn being drawn to a non-elected invention.
Rejections
Claim Rejections - 35 USC § 112(a)
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.
Scope of Enablement
Claims 48-50, 52, 54, 58-60, 62, 66 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 inhibiting HSD17B13, does not reasonably provide enablement for modulating HSD17B13. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The following Wands factors have been considered if not explicitly stated.
(A) The breadth of the claims, (B) The nature of the invention, (C) The state of the prior art, (D) The level of one of ordinary skill, (E) The level of predictability in the art, (F) The amount of direction provided by the inventor, (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
Bread of the claims
Claims 48 and 49 are drawn to methods of modulating HSD17B13 comprising administering a compound of formula I’ or formula I, as recited in the respective claims.
The terms “modulate” and/or “modulating” are not explicitly defined within the specification. The broadest reasonable interpretation includes both inhibition and agonism (activation).
Nature of the invention
The inventions are drawn to methods of modulating HSD17B13 activity, which includes both inhibition and activation.
State of the prior art
The compounds are not disclosed within the art. Therefore, methods of modulation HSD17B13 via administering the compounds of formula I’ or I (claim 48 and 49 respectively) are not disclosed within the art. Administration of similar compounds for the same purpose of modulating HSD17B13 are also not disclosed.
Amount of direction
The instant specification discloses IC50 data for inhibition via administering compounds of formula I and/or I’ in table 63 (p. 525).
There is no data or discussion that would indicate that the compounds work as agonist to increase activity of HSD17B13.
Level of predictability
Considering the lack of available information within the art and the fact that the instant disclosure does not show activation of HSD17B13, the level of predictability should one of ordinary skill in the art administer compounds of formula I’ or I to modulate HSD17B13 is not sufficient for activation. Therefore, the is an undue burden placed on one of ordinary skill in attempts to practice the claimed methods to the full scope of the claims.
The claims are enabled for inhibition.
As claims 50, 52, 54, 58-60, 62, 66 are dependent on claim 48, they are also rejected.
Claim Rejections - 35 USC § 112(b)
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 48-52, 54, 58, 60, 62, 66 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.
Claims referring to Specification
Claim 51 states “The method of claim 48, wherein the compound of formula (I’) is selected from the group consisting of compounds according to Table 3.”
This is reference to a table within the specification. The MPEP section 2173.05(s) states:
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
Additionally, amendments made to the specifications may potentially change the scope of the claim which is improper.
Antecedent Basis
Claim 48 is shown below. There is insufficient antecedent basis for the limitation “R7…” in the claim. There is no prior mention of R7.
As claims 50, 52, 54, 58, 60, 62, 66 are dependent on claim 48, they are also rejected.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUISALBERTO GONZALEZ whose telephone number is (571)272-1154. The examiner can normally be reached M-F 8:30-5:30.
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, Jeffrey Murray can be reached at (571) 272-9023. 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.
/LUISALBERTO GONZALEZ/Examiner, Art Unit 1624
Prosecution Insights