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
Response to Amendment
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/14/2026 has been entered.
Election/Restrictions
Claims 1 and 58 of Group I are now directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 33-34, 37, 46, and 60-63 are directed to the process of making or using the product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 11/02/2023 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Newly amended Claims 1-2, 5, 11, 17-19, 22-23, 25, 28, 31, 33-34, 37, 46, and 58-63 are pending in the application and examined herein. Applicant’s amendments to the Claims have overcome every rejection previously set forth in the Non-Final Office Action mailed 1/16/2026.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
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.
Claims 33-34, 37, 46, and 60-63 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 “reversing, alleviating…or inhibiting the progress of” proliferative diseases in which KDM5 plays a role, does not reasonably provide enablement for “delaying the onset” (tantamount to prevention) thereof. 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.
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.
The nature of the invention (1) and breadth of the claims (6)
The nature of the invention and breadth of Claims 33-34, 37, 46, and 60-63 is the treatment of proliferative diseases, including cancers and specific forms thereof, associated with KDM5 comprising administering compounds of Formula (I) including the particular compound of Claim 58:
PNG
media_image1.png
160
153
media_image1.png
Greyscale
. Paragraph 72 of the specification provides that the term “treating” includes “delaying the onset of,” which is a prophylactic effect.
The state of the prior art (2) and the predictability or lack thereof in the art (3)
The prevention of cancer, let alone all proliferative diseases, is difficult and not reliably achievable through pharmaceutical means. For example, applicant claims the treatment of Ewing’s sarcoma in Claims 4 and 63, which is not known to be preventable. Mayo Clinic (“Ewing sarcoma”. Mayo Clinic. 2018 Online 1-5. Accessed via Wayback Machine, snapshot dated 01/11/2018) teaches plainly “Ewing sarcoma can't be prevented. This type of cancer is not inherited and there is no known link to any lifestyle or environmental issues” (Page 3). It is unclear how the onset of such a disease may be delayed despite there being no known link to inherited, environmental, or lifestyle factors. Applicant has not described the role of KDM5 in relation to said unknown factors with respect to the pathogenesis of the sarcoma so as to delay the onset thereof—let alone delay the many other diseases encompassed by the scope of the claimed methods.
The amount of direction or guidance present (4) and the presence or absence of working examples (5)
Applicant provides examples of therapeutic efficacy of the compounds against KDM5 activity in vitro and in multiple myeloma models in vivo beginning on Paragraph 342. Example 5 demonstrates synthesis of the compounds of Formula (I). Applicant does not provide experimentation which would demonstrate the ability of any of the claimed compounds to prevent or delay the onset of a proliferative disease let alone those particularly claimed.
The quantity of experimentation needed (7)
The quantity of experimentation needed is extremely difficult, novel, and undue experimentation; the ability of the claimed methods to treat, including delay the onset of, proliferative diseases is nearly impossible to determine and not at all enabled by the experiments disclosed in the specifications of the application. Even the ability of Claims 60-63 drawn to a single compound and forms thereof would require assessing prevention of or delaying cancers like Ewing’s sarcoma which “can't be prevented. This type of cancer is not inherited and there is no known link to any lifestyle or environmental issues.” Identifying a patient population for prevention without easily discernable risk factors imposes another difficult hurdle which is not resolved by applicant.
The level of the skill in the art (8)
The level of skill in the art is high; however, even one of the highest skill in the art would recognize the difficulty in treating proliferative diseases like cancer. The same person would also recognize that there is almost no ability to prevent Ewing’s sarcoma as claimed let alone identify specific lifestyle and environmental risk factors associated therewith.
Thus, the specification fails to provide sufficient support of the broad use of the compounds of Formula (I) of the instant claims for the claimed methods which include prophylactic measures.
Claim Rejections - 35 USC § 112(d)
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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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 2 and 5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 depicts
PNG
media_image2.png
90
62
media_image2.png
Greyscale
, corresponding to ring A of Formula (I) of Claim 1, upon which Claim 2 depends. Claim 2 also requires that x be 2 and permits R4 to be an alkenyl for example, which appears to broaden the limitations of ring A of Formula (I) wherein the only acceptable disubstituted phenyl ring A is
PNG
media_image3.png
88
105
media_image3.png
Greyscale
. Claim 5 is rejected by virtue of dependency.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 2 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Labelle (WO2014053491).
Labelle teaches Compound 85 on Page 87:
PNG
media_image4.png
155
410
media_image4.png
Greyscale
, in which the following definitions of Formula (I-A) apply: R1 is H; R1B is ethyl; both R2 are methyl; and R4 is ORA, wherein RA is isopropyl, a C3alkyl, wherein x is 2.
The art rejection over only dependent claims is made in view of 1) applicant’s amendments removing the previously added provisos and 2) the 35 USC 112(d) rejection above describing the broadened limitations, limitations that encompass the above Labelle compound which is excluded from independent Claim 1.
Conclusion
Claims 1, 11, 17-19, 22-23, 25, 28, 31, and 58-59 are allowable. Claims 2, 5, 33-34, 37, 46, and 60-63 are rejected.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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, Kortney Klinkel can be reached on (571) 270-5239. 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.
/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
Prosecution Insights