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 the Claims Claims 1-20 are pending in this application. Claims 1-20 are presently under consideration. Claim Objections Claim s 4 , 16, 18 and 20 are objected to because of the following informalities: The claims should be rewritten to recite “ …. corresponding to amino acid residues 384- 289 389 of NEMO”. Appropriate correction is required. 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 8-11 and 18-19 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 the treatment of an inflammation, does not reasonably provide enablement for the prevention of an inflammation. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. The MPEP states: “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, but are not limited to: (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.” (A) The breadth of the claims ; and (B) The nature of the invention ; The instant invention pertains to method s of treating or preventing an inf lammation comprising administering the claimed IKK2 inhibitor (or a composition comprising the same) . (C) The state of the prior art ; David et al. (Clin Exp Immunol. 2018 Feb 2;193(1):3-12) teach that Immune-mediated inflammatory diseases (IMIDs) are characterized by dysregulation of the normal immune response, which leads to inflammation (abstract). David et al. also teach that IMIDs are genetic disease (page 4, left column, 2 nd para). Thus, since a genetic disease cannot be prevented, a method of preventi n g an inflammation of is uncertain. (D) The level of one of ordinary skill ; The skill of those skilled in the art is high. (E) The level of predictability in the art ; The skilled artisan would view that the preventio n of an inflammation is highly unpredictable. (F) The amount of direction provided by the inventor; and (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. The specification provides experimental results which illustrate that an inflammation can be treated with the claimed IKK2 inhibitor. However, the specification fails to provide scientific data and working embodiments with respect to showing the prevention of any inflammation. The MPEP (2164.02) states that " The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski , 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970).” The MPEP further states that “Lack of a working example, however, is a factor to be considered, especially in a case involving an unpredictable and undeveloped art.” Considering the state of the art as discussed above and the high unpredictability and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to use the invention as claimed. 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 appl icant regards as his invention. Claims 5-6 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. Claim 5 recites “…wherein the inhibitor is a small molecule converted from the peptide NEMO ActPep ”. The phrase “converted from” is unclear. One of ordinary skill in the art would not know what is encompassed by the claim. How is the peptide converted to a small molecule? In order to advance prosecution, the claim has been interpreted as “…wherein the inhibitor is a small molecule converted from comprising the peptide NEMO ActPep ”. Claim 6, which depend from claim 5, is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as th i s claim incorporate s by dependency the indefiniteness of claim 5 . 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 1-20 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) . With respect to claim 1 , Ko teaches “[ a ] peptide spanning residues 375 and 391 and named it NEMO Activation peptide ( NEMO ActPep )” (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 ( NEMO ActPep ) (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, 2 nd 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 w t or mutant peptide was found on these MAP kinases ” (page 107, last para; Fig. 34B). 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, 1 st para) ”. With respect to claim 3, Ko teaches that “[ a ] short segment spanning residues 384 to 389 might constitute the secondary interaction motif ” (page 89, 1 st para; Fig. 22C). With respect to claim 4, Ko teaches that the peptide NEMO ActPep comprises QRRSP (page 94, last para). With respect to claim s 5 -6 , Ko teaches that “[ i ] t is possible that the NEMO ActPep 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, 1 st para). One of ordinary skill in the art would have at once envisaged making a small molecule comprising the peptide NEMO ActPep via peptidomimetic approaches. With respect to claim 7, 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 or preventing 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, 1 st para), and further teach es injecting the peptide (page 115, 1 st para), which must have necessary been in a composition. With respect to claim s 8 and 10 , Ko teaches that “[ T ] he ELISA results were observed that compared with the mice treated with mutant NEMO ActPep , NEMO ActPep showed that the expressions of inflammatory factors IL-1 b , TNF a , IL-2, IP-10, and MIP1 were significantly decreased 1-3 hours after LPS challenge ”, thus reading on the claimed method of treating or preventing an inflammation. With respect to claims 9 and 11, as discussed above, Ko teaches injecting the peptide, which must have necessary been in a composition comprising a pharmaceutically acceptable carrier or excipient. With respect to claims 12-15 and 20, i t is the Examiner’s and the Office’s position that the inclusion of instructions is not a patentably distinguishing feature. This position is also supported by case law (see In re Ngai, 70 USPQ2d 1862 (CAFC 2004); See also MPEP § 2112.01). With respect to claims 16-19, as discussed above, Ko teaches injecting a composition comprising the peptide NEMO ActPep and a pharmaceutically acceptable carrier or excipient. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SERGIO COFFA whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3022 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 6AM-4PM . 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, FILLIN "SPE Name?" \* MERGEFORMAT MELISSA FISHER can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-7430 . 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