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 (2-7), previously presented (10-11, 18), amended (1), cancelled (9, 12-17) Claims 1-8, 10-11, 18-20 are pending in instant application.
Claim Interpretation
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.
Response to Arguments
In light of Applicant’s amendments filed September 1, 2026 the following are withdrawn:
The 35 U.S.C. 102(a)(1) rejection of claims 1-3, 11-13 as being anticipated by US 2014/0031399 A1 to McQuire1.
The remaining rejections have been modified in light of claim amendments.
Applicant's arguments filed September 1, 2026 have been fully considered but they are not persuasive.
Applicant argues that Baker does not treat topical administration (see 9/1/26 Remarks at p. 5), but topical administration is still obvious to an artisan in light of the teachings of Remington as discussed below.
Applicant argues Howell and Harding do not teach treating atopic dermatitis (see 9/1/26 Remarks at p. 6-7), but selecting an MMP13 inhibitor in lieu of another to treat a known condition susceptible to MMP13 inhibition is still obvious as discussed below.
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.
Claims 1-3, 8, 10-13, 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0031399 A1 to McQuire2 in view of WO 2007/011674 A2 to Baker et. al. 3
Regarding claims 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]) such as asthma (see McQuire at claims 1, 3), reading on an allergic inflammatory disease. McQuire teaches methods of treating a disease or disorder mediated by MMP13 and/or MMP12 comprising administering a therapeutically effective amount of disclosed small molecules (see McQuire at claims 1, 3).
Regarding claims 1, 8, 10 and topical administration, McQuire teaches topical delivery systems (see McQuire at p. 8 ¶[0139]). McQuire teaches pharmaceutical compositions comprising the disclosed small molecules and a pharmaceutically acceptable carrier (see McQuire at claim 2).
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, McQuire does not specify i) treating atopic dermatitis or ii) administering the formulated compositions to a subject via specific routes.
However,
Regarding atopic dermatitis, Baker teaches administering an MMP13 inhibitor for treating an inflammatory process such as atopic dermatitis (see Baker at claims 1, 17, 31 and at p. 7 lines 4-14).
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 administering to a subject, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. McQuire teaches administering the composition to treat inflammatory conditions and teaches that the products can be formulated for an administration route such as topical, this reads on administering to the subject as claimed.
Regarding atopic dermatitis, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to an artisan to select a known MMP13 inhibitor (as taught by McQuire) for use in a method of treating atopic dermatitis (as taught by Baker) because the prior art teaches MMP13 inhibitors are useful for treating atopic dermatitis (as taught by Baker).
Furthermore, it is well-within the ordinary skill in art to:
select a known therapy formulated for a suitable administration route to be administered to a subject via the administration route, and/or
select a known member of a known class of drugs for use in known methods.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 1-3, 8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Baker in view of Remington et. al.4
Regarding claims 1-3, 11, Baker teaches administering a combination comprising an MMP13 inhibitor for treating an inflammatory process in a human (see Baker at claims 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), or asthma (see id) reading on an allergic inflammatory disease. 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). An artisan would readily appreciate curcuminoid is a small molecule.
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 i) a therapeutically effective amount or ii) topical administration.
However,
Regarding a therapeutically effective amount, Baker discloses embodiments comprising 15 or 100 mg of curcuminoid, an MMP13 inhibitor as defined by Baker (see Baker at p. 7 lines 4-14).
Regarding claims 1, 8, 10 and topical administration, Remington provides instruction for pharmaceutical manufacturing for various administration routes including topical (see Remington p. 871 chapter 44 “Medicated Topicals”). Remington teaches topical formulations may be formulated with additional components such as penetration enhancers (see Remington at p. 876 Table 44-3), ointment bases (see Remington at p. 880 Table 44-4), or preservatives (see Remington at p. 887 Table 44-6) reading on instant carriers.
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 a therapeutically effective amount, 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.
Regarding topical administration, per MPEP § 2143(I)(A), a prima facie case of obviousness exists for combining prior art elements according to known methods to yield predictable results. It would have been obvious to an artisan to formulate a known treatment for a known skin condition (as taught by Baker) as a topical formulation because the prior art informs artisans how to formulate topical compositions for topical administration (as taught by Remington).
Furthermore, it is well-within the ordinary skill in art to:
determine appropriate dosages of a known substance for use in a known treatment, and/or
formulate a composition according to known methods.
Therefore, an artisan would arrive at the same invention as presently claimed for reasons taught in the prior art.
Claims 1-5, 8, 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Howell et. al.5 in view of Baker and Remington et. al.6
Regarding claims 1-5, 9, 11, and treating an inflammatory disorder 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 therapeutic strategy for asthma or COPD formulated for inhaled administration (see Howell at Abstract, “Conclusions and clinical relevance”), reading on an allergic inflammatory disease.
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) treating atopic dermatitis ii) administering WAY 170523 (CAS# 307002-73-9) to a subject in iii) a therapeutically effective amount, or iv) other administration routes, or v) with a carrier.
However,
Regarding claims 1, 8, 10 and a carrier and topical administration, Remington provides instruction for pharmaceutical manufacturing for various administration routes including topical (see Remington p. 871 chapter 44 “Medicated Topicals”). Remington teaches topical formulations may be formulated with additional components such as penetration enhancers (see Remington at p. 876 Table 44-3), ointment bases (see Remington at p. 880 Table 44-4), or preservatives (see Remington at p. 887 Table 44-6) reading on instant carriers.
Regarding a therapeutically effective amount, Remington teaches the skin behaves as a passive barrier to diffusing molecules, and that penetration of the skin depends on where a substance is administered and the interactions of a drug with its carrier (see Remington at p. 873 left and right col., see also p. 875 “Other Factors Affecting Drug Absorption from the Skin”). Remington thus teaches dosage of a drug formulated for topical administration is a result-effective, optimizable variable.
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 atopic dermatitis, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to an artisan to select a known MMP13 inhibitor (as taught by Howell) for use in a method of treating atopic dermatitis (as taught by Baker) because the prior art teaches MMP13 inhibitors are useful for treating atopic dermatitis (as taught by Baker).
Regarding ii) and administering to a patient, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. It would have been obvious to one skilled in the art that a therapy suggested for clinical relevance in treating a condition would be suitable for administering to a subject to treat a subject with the condition (as taught by Howell).
Regarding ii) and a therapeutically effective amount, it would have been obvious to one skilled in the art to formulate a therapeutically effective amount of a known drug component for topical administration because the prior art teaches the known component (as taught by Howell) and that determining a dosage for topical administration is a result-effective dependent on location, patient, and formulation (as taught by Remington). An artisan would thus need to determine the therapeutically effective amount via routine optimization (see MPEP § 2144.07).
Regarding iv) and v) and topical administration and carriers, it would have been obvious to one skilled in the art to formulate a known therapy (as taught by Howell) for topical administration with carriers because the prior art readily informs artisans methods of formulating for topical administration comprising carrier components (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 Baker and Remington as applied to claims 1-3, 8, 10-11 above and in further view of WO 2007/087637 A2 to Harding7.
The prior art differs from the instant claims as follows: While Baker and Remington teach administering an MMP13 inhibitor for treating atopic dermatitis, 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).
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 atopic dermatitis, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to an artisan to select a known MMP13 inhibitor (as taught by Harding) for use in a method of treating atopic dermatitis (as taught by Baker) with a topical formulation (as taught by Remington) because the prior art teaches MMP13 inhibitors are useful for treating atopic dermatitis (as taught by Baker).
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 Baker and Remington as applied to claims 1-3, 8, 10-11 above and in further view of Engel et. al.8 as evidenced by STN9.
The prior art differs from the instant claims as follows: While Baker and Remington teach administering an MMP13 inhibitor for treating atopic dermatitis, 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):
Regarding atopic dermatitis, per MPEP § 2144.07, a prima facie case of obviousness exists for the selection of a known material based on its suitability for its intended use. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945). It would have been obvious to an artisan to select a known MMP13 inhibitor (as taught by Engel) for use in a method of treating atopic dermatitis (as taught by Baker) with a topical formulation (as taught by Remington) because the prior art teaches MMP13 inhibitors are useful for treating atopic dermatitis (as taught by Baker).
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 1-8, 10-11, 18-20 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOPHIA J REILLY whose telephone number is (703)756-5669. The examiner can normally be reached 9:00 am - 5:00 pm EST M-F.
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, KORTNEY KLINKEL can be reached at 571-270-5239. 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.
/S.R./ Examiner, Art Unit 1627
/JENNIFER A BERRIOS/ Primary Examiner, Art Unit 1613
1 Published January 30, 3014. Cite No. 3 in the IDS filed 7/23/24. Cited in previous Office Action.
2 Published January 30, 3014. Cite No. 3 in the IDS filed 7/23/24. Cited in previous Office Action. Hereinafter McQuire.
3 Published January 25, 2007. Hereinafter Baker. Cited in previous Office Action. Hereinafter Baker.
4 Remington's Pharmaceutical Sciences (21st Ed) New York, NY: Lippincott Williams and Wilkins 2005. Select Pages. Hereinafter Remington.
5 Howell et. al. "Targeting matrix metalloproteinase‐13 in bronchial epithelialrepair" Clinical & Experimental Allergy 2018, 48, 9, 1214-1221. DOI: 10.1111/cea.13215. Hereinafter Howell.
6 Remington's Pharmaceutical Sciences (21st Ed) New York, NY: Lippincott Williams and Wilkins 2005. Select Pages. Hereinafter Remington.
7 Published August 2, 2007. Hereinafter Harding.
8 Engel et. al. "Structural Basis for the Highly Selective Inhibition of MMP-13" Chemistry and Biology 2005, 12, 181-189. DOI: 10.1016/j.chembiol.2004.11.014. Cite No 13 in the IDS filed 7/23/26. Hereinafter Engel.
9 DB 04760 (CAS 544678-85-5) CAS Registry File Accessed March 28, 2026 from STN, entered into STN July 9, 2003.
Prosecution Insights