Prosecution Insights
Last updated: August 06, 2026
Application No. 17/602,361

INTERLEUKIN-4-INDUCED GENE 1 (IL4I1) AS A BIOMARKER AND USES THEREOF

Non-Final OA §101§103§112
Filed
Oct 08, 2021
Priority
Apr 10, 2019 — EU 19168304.4 +1 more
Examiner
FRITCHMAN, REBECCA M
Art Unit
1758
Tech Center
1700 — Chemical & Materials Engineering
Assignee
DEUTSCHES KREBSFORSCHUNGSZENTRUM STIFTUNG DES ÖFFENTLICHEN RECHTS
OA Round
5 (Non-Final)
46%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
82%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allowance Rate
302 granted / 661 resolved
-19.3% vs TC avg
Strong +36% interview lift
Without
With
+35.8%
Interview Lift
resolved cases with interview
Typical timeline
4y 0m
Avg Prosecution
69 currently pending
Career history
748
Total Applications
across all art units

Statute-Specific Performance

§101
4.9%
-35.1% vs TC avg
§103
59.5%
+19.5% vs TC avg
§102
9.2%
-30.8% vs TC avg
§112
20.4%
-19.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 661 resolved cases

Office Action

§101 §103 §112
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 Summary This is the Non-Final Office action based on the 17/602361 RCE filed 06/29/2026. Claims 1, 3-6, 13-14, & 17-24 are pending and have been fully examined. Claims 2, 7-12, & 15-16 have been cancelled. Continued Examination Under 37 CFR 1.114 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/29/2026 has been entered. Claim Interpretation It is noted that for Claim 1, only two real steps are required for the claim: Detecting a modulation of AHR in a cell or subject, by detecting a change in “biological state.” Administering an AHR signaling inhibitor compound or AHR signaling activator compound, of the compounds claimed as the inhibitor or activator, “when,” compared to a control, but it is not always claimed that a comparison to a control happens. The examiner notes that the instant claims can be interpreted very broadly due to use of terms including “biological state,” just “detecting,” with no more specific detecting method or device claimed, and “when compared to a control,” in both of the wherein clause paragraphs. Claim Rejections - 35 USC § 112 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, 3-6, 13-14, & 17-24 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. With respect to Claim 1, what the claimed “biological state,” of IL4I1 is, is unclear, and more particularly it is not clear what exactly an “increase,” or “decrease,” in biological state would be, since no baseline measurement for comparison is claimed as required by only “when,” compared to a control, which reads as conditional and not always occuring. Further, everything in the world can be considered to be in a “biological state,” within it’s environment. For example, any system being in equilibrium can be considered to be a biological state, and in this situation what an increase or decrease in equilibrium would be unclear and then a system would not be in equilibrium. Therefore, it is unclear what is meant by this in the claim. Further for Claim 1, the claim states what an effective amount of the composition administered is, but it does not claim whether an effective amount is actually administered or not. Therefore, it is unclear if an effective amount is administered or not. Further--- as claimed in Claim 1, applicant seems to claim a broad limitation that “AHR signaling inhibitor compound is a small molecule compound having a molecular weight of less than 2000 daltons,” and the “AHR signaling activator compound is a small molecule compound having a molecular weight of less than 2000 daltons,” and the narrower limitation of what the actual AHR signaling activator compound is “selected from the consisting of,” and what the AHR signaling inhibitor is “selected from the consisting of.” This is not permitted as it makes the claims confusing as to what is actually required in the claim. Claims 3-6, 13-14, & 17-24 are rejected by virtue of their dependency on Claim 1. Claim Rejections - 35 USC § 101 35 U.S.C. 101 reads as follows: Whoever invents or discovers any new and useful process, machine, manufacture, or composition ofmatter, or any new and useful improvement thereof, may obtain a patent therefor, subject to theconditions and requirements of this title. The claimed invention of Claims 1, 3-6, 13-14, & 17-24 are directed to non-statutory subject matter. The invention of instant claims 1, 3-6, 13-14, & 17-24 are drawn towards a method of detecting and treating IL4I1 in a biological sample from a cell or subject and thereby detecting modulation of AHR. Through 101, inquiry analysis: Are the claims directed to a statutory category of invention? Yes, independent claim 1 is drawn towards a statutory category of a method. For independent Claim 14 the answer is also yes as it is drawn towards a kit/device or article of manufacture. Step 2A, Prong One: Identify the law of nature/natural phenomenon/abstract ideas. Independent claim 1, involves the judicial exception of a law of nature-- a natural correlation is a law of nature. The natural correlation which is claimed is the level of natural biomarker IL41 in a biological sample or cell, and its correlation with modulation of AHR (aryl hydrocarbon receptor), which is read as (or through broadest reasonable interpretation can be) the state/condition/whether there is a disease or condition associated with AHR modulation. The noticing of an increase or decrease in comparison to a control is also part of the judicial exception itself indicating the natural correlation. And further- the comparison to control is a mental process/abstract idea. Though the instant claim is drawn towards “treating,” as claimed, mostly what is in the claim is implicit diagnostics. This is shown further in the analysis below as though by first glance, “administering AHR signaling inhibitor,” might read as particular and specific as claimed, when looking into the specification and claims in detail, it does not. Further, the claimed “detecting,” for Claim 1 through broadest reasonable interpretation could just be an observation which is a mental process at most broad interpretation and therefore and abstract idea judicial exception. It is noted that no particular detection or sensing device is claimed, so at least broad reads as just data gathering to not particular practical application, and also well understood and routine and conventional so not significantly more. This is further shown in the analysis below. Independent Claim 14 through broadest reasonable interpretation contains a natural biological sample (what is held in the container). Biological samples are products of nature. Step 2A Prong Two: Has the abstract idea or natural correlation been integrated into a particular practical application? For Claim 1 the answer is no. For the instantly claimed, “detecting,” no specific sensor or detector is used. As generally claimed, the instant detecting can mean mentally detecting from looking at a chart. Even if the claimed analysis required an actual analysis device/sensor, then it would amount to mere data gathering which is then used in the abstract idea, if claimed generally. Note that data gathering to be used in an abstract idea is insignificant extra-solution activity, and not a particular practical application. See MPEP 2106.05(g). After, “detecting,” the IL4I1 or AHR, no action which practically applies the judicial exception is taken. Claim 1 requires that, “administering an AHR signaling inhibitor/ or activator compound to treat an AHR-related disease or condition, wherein an effective amount of the AHR signaling modulator compound is about 0.01 mg/kg to about 100 mg/kg,” and “wherein the AHR signaling inhibitor compound is a small molecule compound having a molecular weight of less than 2000 daltons,” and the same claimed for the AHR signaling activator. For a noticed increase when compared to a control the inhibitor of the specifically claimed inhibitors is administered. For a noticed decrease when compared to a control an activator of the specifically claimed activators, is administered. As claimed, it seems the only time a treatment it not administered is “when,” compared to a control, and as broadly worded, the claim does not always require comparison to a control. For the claimed AHR signaling activators and AHR signaling inhibitors, as claimed they are exactly the same compounds to one another. Therefore--- it does not seem like treatment changes in the slightest regardless of whether an increase or decrease is detected. Therefore the treatments as claimed even if a treatment were always required, which the claims do not currently require for the reasons above, are not considered to practically apply the judicial exception since again, the same treatment is performed regardless of the result. Therefore, the treatment is interpreted as extra-solution activity. Even further--- as instantly amended 02/02/2026, both the “AHR signaling activator,” and “AHR signaling inhibitor,” are described as exactly the same compound indicating that the claimed treatment is not particular and specific, nor even dependent at all on the claimed detection. Instead, it seems that the administered compound which is, a “compound is a small molecule compound having a molecular weight of less than 2000 daltons, ” and one which “ is about 01 mg/kg to 100 mg/kg,” for an effective dose is administered regardless of detection or measurement, and even the claimed dose to be “effective,” is the same regardless of if an increase or decrease is measured. See MPEP 2106.04 (d)(2) a.. Further, due to the fact that even if applicant claimed treatment with a particular and specific compound, applicant does not actually claim administration of an effective amount of the treatment, but instead only says in the claim what the effective amount of a treatment would be. The claims do not necessitate the using of the effective amount. For Claim 14 the answer is also no. The claim requires a kit containing materials for performing the method of Claim 1, in one or separate containers. As seen in claim 1, all that is needed is a cell or biological fluid sample and some types of signaling inhibitor or activator which is a “small molecule”. Therefore, applicant is claiming a biological fluid sample and a very unspecific, general compound/molecule or reagent in a container. A container through BRI can be the human body, but even if not, a test tube. Putting a biological fluid in a test tube or them in a container does not make them “markedly different,” from what is found in nature, and as claimed the small molecule is also not markedly different from what is found in nature. Therefore, there is no particular practical application. Step 2B: Do the claims recite any elements which are significantly more than the natural correlation or abstract idea? Here, we look to the elements other than the natural correlation or abstract idea to see if there is significantly more. Claim 1 does not recite any other elements which are considered significantly more. Comparison to a control is routine and conventional in the art so does not change the matters above. The claimed detection is not claimed using and particular reagents or machines that are non-routine and conventional. The treatments in Claim 1 are interpreted the same way as in the practical application step above. What is disclosed in the specification and what was amended to the claims 06/29/2026. Again it is noted that treatment is not always required due to “when,” and that the treatments are claimed exactly the same regardless of the result of detection of increase or decrease. As broadly and generally claimed, these treatments are considered well understood, routine and conventional in the art (WURC) and therefore are not significantly more. Especially at the level of generality claimed, all of these claimed treatments are routine and conventionally used in the art. See LEFRANC in US 20200283395, LEFRANC teaches of using 2-phenylpyrimidine-4-carboxamide compounds as AHR inhibitors (paragraph 0001). This is true even at the level of concentration recited--- of, “about .01 mg/kg to about 100 mg/kg,” as many of them are ingested by humans on a regular basis in small amounts, among other reasons. See MPEP 2106.05 (d) for example what the courts have found to be well understood routine and conventional (WURC) in the art. For Claim 14 the answer is also no. The claim requires a kit containing materials for performing the method of Claim 1, in one or separate containers. As seen in claim 1, all that is need is a cell or biological fluid sample and some type of signaling inhibitor or activator which is a “small molecule”. Therefore, applicant is claiming a biological fluid sample in a container. A contained through BRI can be the human body, but even if not, a test tube. Test tubes are so routinely and conventionally used in the art that this does not move the claims to be a significantly more. Small molecules having the claimed size of less than 2000 daltons are also not markedly different or something which is significantly more or different from what is found in nature. For the claimed treatments, see MPEP 2106.04 (b) and Vanda memorandum. Nothing in any of the dependent claims change the matters above: Claims 3-5 state where the biological state is detected from and what the subject and sample are/are from. All claimed products the state is detected from are natural compounds/products of nature so this does nothing to change the above. Claim 6 states that the control sample is from a healthy subject. Again- a sample from a healthy subject is still a natural sample. Further, using controls from healthy populations is well understood, routine and conventional in the art and therefore does nothing to change the above. Claim 21 states that the modulator is an inhibitor or inducer of IL4I1, or the metabolites are modulated by IL4I1. At the level of generality claimed- this could be almost anything through broadest reasonable interpretation. Further – samples that are modulate by IL4I1 are natural samples as is IL4I1 itself. Therefore-none of this is particular or specific treatment, nor does it change the claims from something that naturally occurs into a practical application or significantly more. Claims 13 & 22 do not change the above. Claim 13 specifies that clustering happen or classification. This is math and also could be a mental process which are abstract ideas themselves. Claims 17-18 state where the metabolite is detected from and what the metabolite is. All claimed products are natural compounds/products of nature so this does nothing to change the above. Claims 19, states what the condition is. This is part of the claimed natural correlation itself and therefore does not change the above. Claim 20 specifies that the state with the modulator is compared to the state without the modulator. Again- this is just viewing of the natural correlation--- and adds no specificity or particularity to the claimed treatment (modulator)—therefore does not change the matters above. Claim 23 does not change the above. Claim 23 specifies stratification into groups. This is a mental process which is an abstract idea itself. Claim 24 does not change the above. Claim 24 depends on Claim 1, and describing what the AHR signaling modulator does, does not make the treatment particular or specific. Also see comments on how AHR signaling modulator is disclosed for Claim 11, as the same applies here. Claim Rejections - 35 USC § 103 The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action: A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. Claims 1, 3-6, 13-14, & 17-24 are rejected under U.S.C. 103 as being obvious over SULLIVAN in WO 2017/189353 (cited on IDS dated 10/08/2021) in view of BOWLES in US 20140213638 and further in view of KRUTMANN in US 20090028804 and further in view of LEFRANC in US 20200283395. With respect to Claim 1 & 20 SULLIVAN teach of a method of detecting, and treating disease by reducing or inhibiting IL4I1 activity (abstract). Specifically, SUILLIVAN teach of detecting association between two substances (Page 6, lines 17- Page 7, end of first paragraph), and of screening for an antagonist of IL4I1 (Page 2, line 30-31) and of monitoring the biological state with respect treatments (Page 12, last paragraph, Page 13, first paragraph). SULLIVAN teaches that the sample is contacted with a candidate modulator compound (inhibitor or activator)/at least one compound (treatment) in a course of treatments and of detecting IL4I1 after and that the treated samples can be compared to the untreated samples (Page 11, line 19-23, Page 12, last paragraph). SULLIVAN teaches of comparison to a healthy volunteer (control)(Page 7, last paragraph). SUILLIVAN teach of detecting association between two substances (Page 6, lines 17- Page 7, end of first paragraph), and of screening for an antagonist of IL4I1 (Page 2, line 30-31). SULLIVAN further teach that the samples are compared to a control (Page 12, line 25-35). Since as claimed, IL411 detection indicates IL4I1 modulation of AHR as instantly claimed (activation or repression)- this makes it obvious that SULLIVAN teaches of “detecting modulation of AHR,” through the claimed method of detecting IL4I1. However, if this is not clear to one of ordinary skill, BOWLES is used to remedy this. BOWLES teaches of a method to measure biomarkers for inflammatory conditions (paragraph 0177, abstract), and of specifically measuring AHR (paragraph 0046, 0174, 0260, 0268), and also of treating the subject with a substance that modulates the detected compounds (paragraph, 0268, 0020-0028, 0034, 0037). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to detect modulation in AHR as is done in BOWLES in the method of SULLIVAN and one would have had reasonable expectation of success due to the potential modulating AHR has shown for modulating failing heart diseases (BOWLES, paragraph 0268). Neither SULLIVAN or BOWLES call out specific treatment with an AHR modulator (activator or inhibitor) which is a small molecule having a molecular weight of under 2000 daltons. KRUTMANN is used to remedy this. KRUTMANN teaches of a method of assessing and using AHR agonists and antagonists (this reads on both activators and inhibitors) (abstract), and even more specifically KRUTMANN teaches of treating with AHR agonists, antagonists, and modulators (Table 1, paragraph 0047, 0044). KRUTMANN teaches that AHR modulators have a sign lightening or darkening affect (abstract) and that these molecules can be kojic acid (which has a molecular weight of around 142.11 Daltons--- this is a material property), or beta-arbutin (which has a molecular weight of 272.5 Daltons (paragraph 0065). These compounds are small compounds and have the claimed molecular weight of “less than,” “2000 Daltons.” KRUTMANN teaches of treatments for conditions such as cancer (paragraph 0044, 0075). KRUTMANN further teaches that the use of AHR antagonists and that in certain situations concentrations of 10 to 20 times the minimum concentration is used (paragraph 0063). KRUTMANN teaches that in other situations only two times the minimum concentration is used (paragraph 0061-0062). KRUTMANN further teaches of determining the minimum effective concentration of the AHR agonists and antagonists by carrying out the methods repeatedly using different concentrations (paragraph 0064). Though KRUTMANN does not call out the exact claimed concentration for treatment with the AHR modulator, it would have been obvious to one of ordinary skill in the art to determine the effective concentration through repeatedly trying different concentration as is done in KRUTMANN above and result in the claimed concentration through routine optimization. See. MPEP 2144.05, II, A. Routine optimization. It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the AHR agonist/antagonist/modulator with the claimed small molecule size as a treatment as is done in KRUTMANN in the methods of SULLIVAN and BOWLES due to the disadvantage that virtually no compounds are known which act as AhR antagonists on human skin and due to the advantages the instant methods offer for determining AHR modulators (KRUTMANN, paragraph 0029, 0031). SULLIVAN, BOWLES, and KRUTMANN do not teach of the claimed specific compounds for the AHR inhibitor or activator claimed as “consisting of.” LEFRANC is used to remedy this and teaches of compounds used as AHR inhibitors (abstract). LEFRANC further teaches of using 2-phenylpyrimidine-4-carboxamide compounds as AHR inhibitors (paragraph 0001). It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use the AHR inhibitor as is done in LEFRANC in the methods of SULLIVAN, BOWLES and KRUTMANN due to the advantage it has in inhibiting AHR effectively and therefore control inappropriate immune response (paragraph 0006, 0016). With respect to Claim 2, SULLIVAN teaches of detecting inflammatory lung disease by the method of claim 1, which is, “inflammation,” (Page 10, lines 19-30). With respect to Claims 3-5, SULLIVAN teaches of detecting a biological component (such as an IL4I1 protein, antibody, or nucleic acid molecule) has been substantially separated, produced apart from, or purified away from other biological components in the cell of the organism in which the component occurs, such as other chromosomal and extrachromosomal DNA and RNA, and proteins. Nucleic acids molecules and proteins which have been "isolated" thus include nucleic acids and proteins purified by standard purification methods. The term also embraces nucleic acid molecules and proteins prepared by recombinant expression in a host cell as well as chemically synthesized nucleic acids. A purified or isolated cell, antibody, protein, or nucleic acid molecule can be at least 70%, at least 80%, at least 90%, at least 95%, at least 96%, at least 97%, at least 98%, or at least 99% pure (Page 9, lines 18-26). SULLIVAN further teach that the sample can be from a mammal and that this term includes both human and non-human mammals. Similarly, the term "subject" includes both human and veterinary subjects (such as cats, dogs, horses, cows, and pigs) and rodents (such as mice and rats) (Page 9, line 27-30). With respect to Claim 13, SULLIVAN teaches the above as shown for claim 1, but does not teach of clustering or classification as claimed. BOWLES is used to remedy this and teaches of claim 1 as shown above. BOWLES further teaches of performing hierarchial clustering for all peptides (paragraph 0044, 0169, 0252). It would have been obvious to one of ordinary skill in the art to perform clustering on the obtained measurements and data as is done in BOWLES in the method of SULLIVAN and one would have had reasonable expectation of success due to the advantage it offers in being able to group data in order to observe overall expression patterns (BOWLES, paragraph 0252). With respect to Claim 14, SULLIVAN teaches of using carriers, binding agonists (Page 10, last paragraph and second paragraph), and of containing the parts in plates/containers (Page 17, line 10- bottom). Though this makes containing all components claimed in a kit obvious, since SUILLIVAN does not call out the use of a kit, BOWLES is used to remedy this. BOWLES further teaches of using a kit for determination of the biomarkers (paragraph 0014). It would have been obvious to one of ordinary skill in the art to use a kit for determination and diagnosis of the disease as is done in BOWLES in the method of SULLIVAN and one would have had reasonable expectation of success with biomarkers due to the advantage this would offer in ease of use. With respect to Claim 17, SULLIVAN teaches of the metabolites which are measured being produced by IL4I1(such as IL4I1 protein, antibody, or nucleic acid molecule) (Page 9, line 18026). With respect to Claim 18, SULLIVAN teaches of the cells being myeloid- cells or B- cells among other cell types (Page 9, lines 5-17). With respect to Claim 19, SULLIVAN teaches of Claim 5 as shown above, but does not teach of AHR. BOWLES is used to remedy this. BOWLES teaches of a method to measure biomarkers for inflammatory conditions (paragraph 0177, abstract), and of specifically measuring AHR (paragraph 0046, 0174, 0260, 0268), and also of treating the subject with a substance that modulates the detected compounds (paragraph, 0268, 0020-0028, 0034, 0037). It would have been obvious to one of ordinary skill in the art to detect modulation in AHR as is done in BOWLES in the method of SULLIVAN due to the potential modulating AHR has shown for modulating failing heart diseases (BOWLES, paragraph 0268 ). With respect to Claim 21, SULLIVAN teaches of the metabolites which are measured being produced by/modulate by IL4I1(such as IL4I1 protein, antibody, or nucleic acid molecule) (Page 9, line 18026). With respect to Claim 22, SULLIVAN teaches the above as shown for claim 1, but does not teach of clustering or classification as claimed. BOWLES is used to remedy this and teaches of claim 1 as shown above. BOWLES further teaches of performing hierarchical clustering for all peptides (paragraph 0044, 0169, 0252). It would have been obvious to one of ordinary skill in the art to perform clustering on the obtained measurements and data as is done in BOWLES in the method of SULLIVAN and one would have had reasonable expectation of success due to the advantage it offers in being able to group data in order to observe overall expression patterns (BOWLES, paragraph 0252). With respect to Claim 23, SULLIVAN teaches of the claimed invention as shown above for Claim 13, but does not teach of stratification or placement into groups. BOWLES teaches this (paragraph 0160, 0169, 0241 among others). It would have been obvious to group the results as is done in BOWLES in the method of SULLIVAN and one would have had reasonable expectation of success due to the advantage this offers in determination of disease state (paragraph 0252). With respect to Claim 24, SULLIVAN and BOWLES do not teach of the AHR modulator as claimed in Claim 24. KRUTMANN is used to remedy this. KRUTMANN teaches of a method of assessing and using AHR agonists and antagonists (abstract), and even more specifically KRUTMANN teaches of treating with AHR agonists, antagonists, and modulators (Table 1, paragraph 0047, 0044). KRUTMANN further teaches that the use of AHR antagonists and that in certain situations concentrations of 10 to 20 times the minimum concentration is used (paragraph 0063). KRUTMANN teaches that in other situations only two times the minimum concentration is used (paragraph 0061-0062). KRUTMANN further teaches of determining the minimum effective concentration of the AHR agonists and antagonists by carrying out the methods repeatedly using different concentrations (paragraph 0064). KRUTMANN further shows that AHR modulator can be an inhibitor of the AHR signal pathway (paragraph 0060). It would have been obvious to one of ordinary skill in the art to use the AHR agonist/antagonist/modulator as a treatment of KRUTMANN in the methods of SULLIVAN and BOWLES due to the disadvantage that virtually no compounds are known which act as AhR antagonists on human skin and due to the advantages the instant methods offer for determining AHR modulators (KRUTMANN, paragraph 0029, 0031). Response to Arguments Applicant's arguments filed 06/29/2026 have been fully considered but they are not persuasive. The examiner notes that after further review there are clarity issues with the claims that influence both the 101 rejections and the 103 rejections in that the claims can be interpreted broadly given these issues. Further—as the claims have been significantly amended 06/29/2026--- please the examiners comments regarding the rejections above for the significantly amended claims, instead of here in the response to arguments--- as all of the new claim limitations which applicant argues about are addressed in the rejections. Further- the examiner notes that due to how broadly the claims can be interpreted, a new prior art reference was not needed to teach of the claimed AHR activator compounds or AHR inhibiting compounds--- however a new reference was used in the interest of compact prosecution. However, it is noted that LEFRANC in US 20200283395, LEFRANC teaches of using 2-phenylpyrimidine-4-carboxamide compounds as AHR inhibitors (paragraph 0001). Therefore, the prior art does teach of what applicant argues it does not, the amendment dated 06/29/2026. Therefore all claims remain rejected. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M FRITCHMAN whose telephone number is (303)297-4344. The examiner can normally be reached 9:30-4:30 MT Monday-Friday. 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, Maris Kessel can be reached on 571-270-7698. 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. /REBECCA M FRITCHMAN/Primary Examiner, Art Unit 1758
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Prosecution Timeline

Show 5 earlier events
Sep 16, 2025
Request for Continued Examination
Sep 17, 2025
Response after Non-Final Action
Oct 02, 2025
Non-Final Rejection mailed — §101, §103, §112
Feb 02, 2026
Response Filed
Feb 27, 2026
Final Rejection mailed — §101, §103, §112
Jun 29, 2026
Request for Continued Examination
Jun 30, 2026
Response after Non-Final Action
Jul 14, 2026
Non-Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
46%
Grant Probability
82%
With Interview (+35.8%)
4y 0m (~0m remaining)
Median Time to Grant
High
PTA Risk
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