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
Election/Restrictions
Applicant's election with traverse of Group I and the species recited in claim 4 in the reply filed on 6/11/2026 is acknowledged. The traversal is on the ground(s) that “[t]he inventions described in these claims are not "independent" as defined in MPEP § 803, and each pertains to the same or corresponding "special technical features" which are so linked as to form a single general inventive concept, i.e., the claimed small molecule compound that specifically inhibits IKK2 activation by targeting a second interaction interface between NEMO and IKK2 that is dependent upon NEMO binding to linear polyubiquitin; and the method of using the same and the kit comprising the same”. Applicant also argues that “[K]o's operative disclosure is a peptide, not a small molecule compound derived from the NEMO second interaction interface via a peptidomimetic chemical approach”. This is not found persuasive because Ko teaches that “[i]t is possible that the NEMOActPep will serve as a model for the future development of new generations of inhibitors such as small molecules or peptidomimetics designed to insert into the IKK binding groove of NEMO (page 131, 1st para). Therefore, the skilled artisan would have at once envisaged making a small molecule comprising the peptide NEMOActPep via peptidomimetic approaches.
The requirement is still deemed proper and is therefore made FINAL.
Claims 8, 10, 12, 14 and 22-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/11/2026.
Status of the Claims
Claims 1-2, 4, 7-8, 10, 12, 14 and 21-25 are pending in this application.
Claims 8, 10, 12, 14 and 22-25 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 1-2, 4, 7 and 21 are presently under consideration as being drawn to the elected species/invention.
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.
Claims 1-2, 4, 7 and 21 are 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 claim(s) 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 claims are drawn to a small molecule compound that specifically inhibits IKK2 activation by targeting a second interaction interface between NEMO and IKK2 that is dependent upon NEMO binding to linear polyubiquitin, wherein said small molecule compound is derived from the second interaction interface of NEMO via a peptidomimetic chemical approach, and wherein said small molecule compound does not block MAP kinase phosphorylation or IKK1 via a non-canonical NF-kB activation pathway.
When referring to the small molecule compound, the specification does not provide any structural attributes.
Without a correlation between structure and function, the claims do little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (“A definition by function alone “does not suffice” to sufficiently describe a coding sequence because it is only an indication of what the gene does, rather than what it is”).”
Here, the specification fails to describe which small molecule compounds derived from the second interaction interface of NEMO via a peptidomimetic chemical approach correlate with the required activity (inhibiting IKK2 activation by targeting a second interaction interface between NEMO and IKK2; and not blocking MAP kinase phosphorylation or IKK1 via a non-canonical NF-kB activation pathway).
The MPEP states that a broad genus can be described by a showing of representative number of examples. The claims in the instant application are broad.
Based on the teachings of the specification, the small molecule compound can be any compound derived from the second interaction interface of NEMO via a peptidomimetic chemical approach.
However, the specification fails to provide a representative number of examples for the claimed small molecule compound.
The specification teaches only one sequence (i.e. SEQ ID NO: 1) among the immense number of possible compounds that could be derived from the second interaction interface of NEMO via a peptidomimetic chemical approach.
The description requirement of the patent statute 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 a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Therefore, since the specification fails to identify any relevant structural characteristics that can be attributed to the claimed function and activity, the claimed invention lacks written description.
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 1-2, 4, 7 and 21 are 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.
The term “small” in claims 1-2, 4, 7 and 21 is a relative term which renders the claims indefinite. The term “small” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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 1-2, 4, 7 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ko (Dissertation; Understanding the role of NEMO in IKK activation; January 1, 2020; previously cited).
With respect to claim 1, Ko teaches “[a] peptide spanning residues 375 and 391 and named it NEMO Activation peptide (NEMOActPep)” (page 94, last para).
Ko also teaches that “[T]he segment of NEMO spanning residues 384QRRSPP389 can act either as an inhibitor or activator of IKK2 in isolation, referred this peptide as to (NEMOActPep) (Fig. 25).
Ko further teaches that “[N]EMO and IKK2/β interact through a ‘second interaction site’ in M1-Ub-chain dependent manner (page 88, 2nd para).
Ko additionally teaches that “[T]o further show specificity of the peptide, I tested if MAPK activation by TNF-a is affected by the inhibitor by monitoring activation of JNK, Erk2 and p38. As expected all three MAP kinases are activated by TNF-a but no effect of either the wt or mutant peptide was found on these MAP kinases” (page 107, last para; Fig. 34B).
Ko also teaches that “[a] short segment spanning residues 384 to 389 might constitute the secondary interaction motif” (page 89, 1st para; Fig. 22C).
Ko further teaches that “[i]t is possible that the NEMOActPep will serve as a model for the future development of new generations of inhibitors such as small molecules or peptidomimetics designed to insert into the IKK binding groove of NEMO (page 131, 1st para). One of ordinary skill in the art would have at once envisaged making a small molecule comprising the peptide NEMOActPep via peptidomimetic approaches.
With respect to claim 2, Ko teaches “[A] short peptide segment immediately upstream of the Zn-finger domain of NEMO is essential for IKK2/β activation (page 94, 1st para)”.
With respect to claim 4, Ko teaches that the peptide NEMOActPep comprises QRRSP (page 94, last para).
With respect to claims 7 and 21, it is noted that “[d]uring examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim” (MPEP 2111.02). In the instant case, the limitation “for treating an inflammation” is an intended use, thus is not given any patentable weight. Furthermore, Ko teaches that the peptide was dissolved in PBS (page 74, 1st para), and further teaches injecting the peptide (page 115, 1st para), which must have necessary been in a composition.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658
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