DETAILED ACTION 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. Priority The instant application is a 371 National Stage Entry of PCT/US22/72524 filed on May 24, 2022 which claims priority to foreign application No. 63/192,867 filed on May 25, 2021. Status of Claims Acknowledgement is made of original ( 1-7 , 13-14, 17, 19 ), amended ( 8 -12, 15-16, 18, 20 ), claims filed on November 22, 2023 . Claims 1-20 are pending in instant application. Information Disclosure Statement The information disclosure statement filed on July 23, 2024 has been considered . Claim Interpretation The instant specification states “allergic inflammatory diseases such as atopic dermatitis and asthma” (see instant spec. p. 1) and the claims state “allergic asthma” (see claims 12-13). It is understood that any prior art discussing treatment of asthma will read on instant “allergic asthma”. The instant specification states “any inhibitor of MMP13 (e.g. those described herein) can be mixed with a pharmaceutically acceptable excipient (carrier) to form a pharmaceutical composition” (see instant spec at p. 12 lines 11-12). Excipients and carriers are thus understood to be interchangeable terms. Prior art discussing excipients is thus prior art discussing carriers. 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. Claim s 1-3, 11-13 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by US 2014/0031399 A1 to McQuire . Regarding claim s 1-3, 11 - 13 and methods of treating allergic inflammatory diseases with MMP13 inhibitors , McQuire teaches inhibitors of MMP13 and/or MMP12 (see McQuire at Abstract). McQuire teaches methods of treating inflammatory conditions (see McQuire at p. 9 ¶[00153]). McQuire teaches methods of treating a disease or disorder mediated by MMP13 and/or MMP12 including asthma and rhinitis comprising administering a therapeutically effective amount of disclosed small molecules (see McQuire at claim s 1, 3). 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. Claim s 8, 10, 15-16, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0031399 A1 to McQuire as applied to claims 1-3, 11-13 above. Regarding claim 10 and a composition, McQuire teaches pharmaceutical compositions comprising the disclosed small molecules and a pharmaceutically acceptable carrier (see McQuire at claim 2). Regarding claim s 8, 15 and topical administration, McQuire teaches topical delivery systems (see McQuire at p. 8 ¶[0139]). Regarding claim 16 and systemic administration, McQuire teaches oral and injectable suitable compositions (see McQuire at p. 8 ¶[0136] and ¶[0137]). Regarding claims 18-20 and additional agents and formulation, McQuire teaches administering in combination with another therapeutic agent such as an anti-inflammatory agent including ibuprofen (see McQuire at p. 9 ¶[0144]), including simultaneous administration of a fixed combination with both active ingredients (see McQuire at p. 9 ¶[0145]). The prior art differs from the instant claims as follows: While McQuire teaches small molecule MMP13/MMP12 inhibitors for treating inflammatory conditions such as asthma, McQuire does not specify i) administering the formulated compositions to a subject via specific routes . However, I t would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s): Per MPEP § 2144.07, a prima facie case of obviousness exists for t he selection of a known material based on its suitability for its intended use . McQuire teaches administering the composition to treat inflammatory conditions of asthma and rhinitis and teaches that the product s can be formulated for an administration route such as topical or oral, this reads on administering to the subject as claimed. Furthermore, it is well-within the ordinary skill in art to : - select a known therapy for mulated for a suitable administration route to be administered to a subject via the administration route. Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art. Claim s 1, 11- 12, 14 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2007 / 011674 A2 to Baker . Regarding claims 1, 11-12, 14, Baker teaches administering a combination comprising an MMP13 inhibitor for treating an inflammatory process in a human (see Baker at claim s 1, 17 and at p. 7 lines 4-14 , e.g. “curcuminoids, catechins, boswellic acids ), wherein the inflammatory process may be dermatitis (see Baker at claim 26) , and may be atopic dermatitis (see Baker at claim 31) . Baker teaches formulations comprising 500 mg of total active ingredient in a tablet including 100 mg of curcuminoid (see Baker at p. 58 Formulation 11) , or 15 mg of curcuminoid in a capsule (see Baker at p. 56 Formulation 8). The prior art differs from the instant claims as follows: While Baker teaches administering an MMP13 inhibitor for treating an inflammatory process such as atopic dermatitis, Baker does not specify a therapeutically effective amount. However, Baker discloses embodiments comprising 15 or 100 mg of curcuminoid, an MMP13 inhibitor as defined by Baker. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s): Per MPEP § 2144.05(II), it would have been obvious to one skilled in the art to determine a therapeutically effective amount through routine optimization because Baker teaches multiple formulation embodiments with different amounts of the MMP13 inhibitor curcuminoid, recognizing dosage as a result-effective variable dependent on the patient type and administration route. Accordingly an artisan could arrive at a therapeutically effective amount of the MMP13 inhibitor curcuminoid for the desired administration route. Furthermore, it is well-within the ordinary skill in art to determine appropriated dosages of a known substance for use in a known treatment, Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art. Claims 1-5, 8 -13, 15- 17 are rejected under 35 U.S.C. 103 as being unpatentable over Howell et. al. in view of Remington et. al. Regarding claims 1-5, 9, 11-13, 17 and treating an inflammatory disorder such as asthma with an MMP13 inhibitor species , Howell teaches WAY 170523 (CAS# 307002-73-9) is an MMP13 inhibitor (see Howell at Abstract). Howell suggests using WAY 170523 (CAS# 307002-73-9) as a t herapeutic strategy for asthma or COPD formulated for inhaled administration (see Howell at Abstract , “Conclusions and clinical relevance” ). The prior art differs from the instant claims as follows: While Howell teaches WAY 170523 (CAS# 307002-73-9) as a suitable treatment for asthma or COPD , Howell does not specify i) administering WAY 170523 (CAS# 307002-73-9) to a subject in ii) a therapeutically effective amount , iii) a formulation for inhalation , or iv) other administration routes, or v) with a carrier. However, Regarding claims 9-10, 15 and inhaled administration, Howell suggests administering for inhalation (see Howell at p. 1220 left col. ¶2). Remington teaches inhalation administration is used for the treatment of asthma (see Remington at p. 1000 left col. ¶1) and teaches methods of formulating aerosols for inhaled delivery (see Remington at Chapter 50 pp. 1000-1017). Remington teaches metered dose inhalers are formulated with active ingredients, excipients (reading on instant carriers), and a propellant (see Remington at p. 1000 right col. ¶4). Regarding a therapeutically effective amount, Remington teaches metered dose inhalers are filled with active ingredients and a meter dose valve that when dispensed, dispenses an exact amount of a drug to achieve maximu m deposition of the drug into the lungs (see Remington at p. 1000 right col. ¶4). Regarding claims 8, 15, 16 and topical and systemic administration, Remington provides instruction for pharmaceutical manufacturing for various administration routes including systemic (see Remington p. xxi chapter 45 “Oral Solid Dosage Forms” , chapter 42 “Intravenous Admixtures” ) and topical (see Remington p. xxi chapter 44 “Medicated Topicals ”) . Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s): Regarding i) and administering to a patient, Per MPEP § 2144.07, a prima facie case of obviousness exists for t he selection of a known material based on its suitability for its intended use . I t would have been obvious to one skilled in the art that a therapy suggested for clinical relevance in treating asthma would be suitable for administering to a subject to treat a subject with asthma (as taught by Howell). Regarding ii) and a therapeutically effective amount and iii) inhaled administration, it would have been obvious to one skilled in the art to formulate a therapy suggested for inhaled administration to treat asthma (as taught by Howell) as an inhaled formulation including a metered dose inhaler (as taught by Remington) because the prior art teaches it is a suitable drug delivery system for treating asthma (as taught by Remington) (see also MPEP § 2144.07 and § 2143(I)(G)). In addition, the administration via a metered dose inhaled would require identifying a therapeutically effective amount to be administered (as taught by Remington). Regarding iv) and other administration routes, it would have been obvious to one skilled in the art to formulate a known therapy (as taught by Howell) for various administration routes because the prior art readily informs artisans methods of formulating for various administration routes and advantages for each route (as taught by Remington). Furthermore, it is well-within the ordinary skill in art to : - select a proposed asthma therapy for use in treating asthma in a subject, and - identify a therapeutically effective dose of a known substance for a known condition. Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Howell in view of Remington as applied to claims 1-5, 8-13, 15-17 above and in further view of WO 2007/087637 A2 to Harding and Bratek et. al. Recall Howell teaches an MMP13 inhibitor (WAY 170523) for treating asthma or COPD (see Howell at Abstract). The prior art differs from the instant claims as follows: While Howell and Remington teach administering an MMP13 inhibitor for treating an inflammatory disorder, they do not specify administering CL82198 (CAS # 307002-71-7) . However, Harding teaches CL82198 is an MMP13 inhibitor (see Harding at p. 19 Table 1). Harding teaches administering a therapeutically effective amount of CL82198 to a subject to treat cognitive impairment (see Harding claims 1, 22). Bratek teaches COPD and asthma have comorbidities with depression, anxiety, and cognitive dysfunctions (see Bratek at Abstract). Bratek teaches the impaired cognitive function is likely due to airflow obstruction (see Bratek at p. S89 left col. “Conclusions”). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s): Per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. It would have been obvious to one skilled in the art to substitute one known MMP13 inhibitor ( WAY 170523, a s taught by Howell) for another known MMP13 inhibitor ( CL82198 , as taught by Harding) in order to treat an inflammatory condition such as asthma because the prior art teaches inhibiting MMP13 is a therapeutic strategy for treating asthma in subjects (as taught by Howell and Remington) , and the alternative MMP13 inhibitor is known in the art for treating an asthma comorbidity (cognitive dysfunction, as taught by Harding and Bratek ) Furthermore, it is well-within the ordinary skill in art to incorporate one known drug in lieu of another known drug. Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Howell in view of Remington as applied to claims 1-5, 8-13, 15-17 above and in further view of Engel et. al. as evidenced by STN . The prior art differs from the instant claims as follows: While Howell and Remington teach administering an MMP13 inhibitor for treating an inflammatory disorder, they do not specify administering DB04760 (CAS # 544678-85-5) . However, Engel teaches Compound 4, and STN teaches Compound 4 is DB04760 and CAS # 544678-85-5 , is a selective MMP13 inhibitor (see Engel at p. 182 Figure 1 Compound 4). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to arrive at the instantly claimed invention with a reasonable expectation of success in view of the prior art for at least the following reason(s): Per MPEP § 2143(I)(B), a prima facie case of obviousness exists for simple substitution of one known element for another to obtain predictable results. It would have been obvious to one skilled in the art to substitute one known MMP13 inhibitor (a taught by Howell) for another known MMP13 inhibitor (as taught by Engel) in order to treat an inflammatory condition such as asthma because the prior art teaches inhibiting MMP13 is a therapeutic strategy for treating asthma in subjects (as taught by Howell and Remington). Furthermore, it is well-within the ordinary skill in art to incorporate one known drug in lieu of another known drug. Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art. Conclusion Claims 1-20 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT SOPHIA J REILLY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-5669 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 9:00 am - 5:00 pm EST M-F . 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