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
Status of 18/797,261
Claims 1-20 are currently pending.
Priority
Instant application 18/797,261, filed 8/7/2024, claims priority as follows:
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The priority documents submitted in the file wrapper are not translated to English and as a result, foreign priority cannot be established. However, the provisional filed 63/308,883 filed 2/10/2022 contains support for the instant claims and thus, the instant claims are granted the effective filing date of 2/10/2022.
Information Disclosure Statement
All references from the IDS’s on the PTO-1449 forms submitted on 1/14/2025 and 5/18/2026 have been considered unless marked with a strikethrough.
The Examiner notes that IDS submissions of 1/14/2025 and 5/18/2026 on homemade forms other than the 1449 forms were not technically considered because of the incorrect documentation. If Applicant would like the references considered, then it is requested to please submit them on the appropriate form.
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.
Claim 17 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, the claims of the instant application embrace a crystalline compound with the following structure:
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Including an XRPD pattern, pharmaceutical compositions thereof, and a method of treating a cancer that is mediated by IKZF1 and/or IKZF3 with the crystalline compound.
Particularly, the term ”cancer that is mediated by IKZF1 and/or IKZF3” invokes the 35 U.S.C. 112(a) rejection. Even a cursory calculation of the number of cancers embraced in the instant claims would result in thousands of diseases.
The genus of cancers mediated by IKZF1 and/or IKZF3 is not fully defined in the instant disclosure nor is the term “mediated” with respect to the genus of cancers encompassed by the instant claims. Applicants fail to describe the full scope of mediated by IKZF1 and/or IKZF3 and thus, it is unclear where the possession of the association lie. Though cancer is known in the art, the description is not adequate to allow one skilled in the art to ascertain that Applicant is in possession of the knowledge of the entire scope of the genus.
A review of the prior art at the time of filing identifies Xia (Xia, R. et. al. Front. Mol. Biosci. 2021, 8, 788440), which is drawn to the role of Ikaros in tumorgenesis, the mechanism of drug resistance related to Ikaros, process of targeting Ikaros in clinical trials, and potential use in cancer therapy (abstract). Specifically, Xia teaches the Ikaros family proteins and related diseases (section 1.2), and further teaches the large scope of clinical trials treating a myriad of conditions related to Ikaros (Table 3). Xia teaches cancers that are related to Ikaros such as breast cancer (page 4, second paragraph), but does not teach the full scope of cancers mediated by IKZF1 and/or IKZF3 that are able to be treated. Further, Xia does not teach a single small molecule able to treat the cancers mediated by IKZF1 and/or IKZF3 of Xia, and provides no indication that would point one of ordinary skill to the full scope of cancers mediated by IKZF1 and IKZF3 that are able to be treated. Applicant has not demonstrated the possession of the knowledge of which cancers would or would not have this function.
In addition to the lack of structure/function relationship established, there is also an insufficient representative number of examples. As described in MPEP § 2163, for a generic claim the genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient variety of species to reflect the variation within that genus. The instant specification provides examples of cancers mediated by IKZF1 and/or IKZF3 as a lymphoma, a leukemia, or a myeloma (page 57, lines 23-24), and further delineates specific lymphomas, leukemias, and myelomas to treat (pages 57-59), indicating that the instant disclosure does not provide descriptive support for the genus of the claims. Applicant has not described the claimed genus of treating “cancers mediated by IKZF1 and/or IKZF3” in a manner that would indicate they were in possession of the knowledge of the full scope of the genus, or even to describe what the genus is comprised of.
Methods of treating lymphomas, leukemias, and myelomas are, in general, known to the person of ordinary skill; however, methods of treating cancers mediated by IKZF1 and/or IKZF3 embraced by the instant claims are beyond the skill of the artisan, particularly when the term, “mediated by” is not described. As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what additional elements may be present in the methods.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. This rejection can be overcome by redrafting the claim to omit the term “cancers mediated by IKZF1 and/or IKZF3”.
Close Prior Art Not Cited
Close prior art identified during the search is C4 Therapeutics inc. (WO 2022/032132 A1, cited in the IDS of 1/14/2025, herein after C4 ‘132), which teaches compound I (page 5):
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Which is a cereblon binder that degrades Ikaros or Aiolos by the ubiquitin proteasome pathway (abstract). In addition to compound I, which is the same compound in the crystalline form of the instant claims, C4 ‘132 teaches the treatment of multiple instances of multiple myeloma, non-Hodgkin’s lymphoma, and B-cell lymphoma (page 172, Table 5), which helps support instant claims 18-20. Though C4 ‘132 teaches compound I, the reference does not teach a crystal form of the compound and it would not be obvious to one of ordinary skill in the art to arrive at the limitations of the instant claims from the teachings of C4 ‘132, alone or in combination with the prior art.
Allowable Subject Matter
Claims 1-16 and 18-20 are allowed.
Conclusion
Claim 17 is rejected. Claims 1-16 and 18-20 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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