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 .
Current Status of 17/918,973
This Office Action is responsive to the amended claims of 12/22/2025.
Claims 32, 35-41, and 44-57 have been examined on the merits.
Priority
This application is a national stage entry of PCT/US2021/027593, which claims priority to US provisional 63/011,874.
The instant claims find support from the US provisional application. Therefore, the effective filing date is 4/17/2020.
Response to Arguments
Applicants’ claim amendments and Remarks of 12/22/2025 are acknowledged and have been considered.
Any rejection and/or objection not specifically addressed or modified below is herein withdrawn.
The new claims find support from the original specification.
In regard to the 102 rejection, this rejection is withdrawn because of applicants amendments.
In regard to the 103 rejection, this rejection is maintained. Applicants remarks with Examiner’s reply are summarized below:
Applicants submit that there is nothing to suggest why one of ordinary skill would have selected any compound in Estrada to reduce inflammation and reduce symptoms related to a virus infection in a subject at risk of or having CRS.
Examiner disagrees. Estrada teaches that Compound 42 is useful in reducing inflammation (paragraph [2006]). The instant claims are directed to a method of reducing inflammation and reducing symptoms related to a virus infection (which includes inflammation) in a subject at risk of or having Cytokine Release Syndrome. It still would be obvious to administer a compound (known to be useful in reducing inflammation) to a subject in need of reducing inflammation. The artisan would expect that Compound 42 would reduce inflammation in a subject.
Applicants have not addressed how Compound 42 would not be effective for a subject at risk of or having CRS. Applicant could also submit unexpected/surprising results in order to overcome this obviousness rejection.
Applicants submit that Estrada only briefly mentions viruses (paragraph [0944]) which is separate from inflammatory diseases (paragraph [0899]-[0901]).
This is not persuasive.
Response to Amendment
This Rejection is maintained and updated due to Applicant’s Amendments.
Claim Rejections - 35 USC § 103- MAINTAINED
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) 32, 35-41, and 44-48 are rejected under 35 U.S.C. 103 as being unpatentable over ESTRADA (US PG PUB 2017/0226127) as evidenced by BOSMANN (Bosmann and Ward, “The Inflammatory Response in Sepsis”, Trends Immunol., March 2013) and in view of VORHAGEN (Shimakukuro-Vornhagen et al., “Cytokine release syndrome”, Journal for Immunotherapy of Cancer,2018) and BOULLATA (J. Boullata, “Drug Administration through a Feeding Tube”, OLEY Nutrition Support, September/October 2011).
ESTRADA teaches the compound referred to as Compound 42, which is a RIPK1 inhibitor,
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(page 66). This is the same compound from the base instant claims (see the specification page 13 for a picture of the instant compound). ESTRADA teaches a method of reducing inflammation in a subject (mouse) having systemic inflammatory response by orally administering Compound 42 (paragraph [2006]). This teaches a compound of claim 32 reducing inflammation, and 41.
ESTRADA teaches the total daily dosage for a human subject may be between 1 mg and 1,000 mg per day (paragraph [1009]). This teaches claims 35-40.
ESTRADA teaches treating a subject in a hyperinflammatory state, i.e. SIRS, (paragraph [2006]).
BOSMANN is relied upon for the beneficial teaching that systemic inflammatory response syndrome (SIRS) is a hyperinflammatory state (“A hyperinflammatory state develops that is referred to as SIRS”; introduction second paragraph). This helps teach claim 48.
ESTRADA teaches a method of treating infectious disease (i.e. reducing symptoms related to a virus infection) resulting from the presence of pathogenic agents, including pathogenic viruses such as corona virus by administering compound 42 (paragraph [0944]). This teaches claims 43-44.
ESTRADA teaches an additional agent of corticosteroid such as prednisolone (paragraph [0995-0996 and 1006]). This teaches claims 45 and 46.
ESTRADA does not teach Cytokine release syndrome (CRS).
VORHAGEN teaches that Cytokine release syndrome (CRS) is a systemic inflammatory response (SIRS) that can be triggered by a variety of factors such as infections and certain drugs (background).
Estrada teaches that Compound 42 is useful in reducing inflammation (paragraph [2006]). It would be obvious to administer a compound (known to be useful in reducing inflammation) to a subject in need of reducing inflammation. The artisan would expect that Compound 42 would reduce inflammation in a subject at risk of or having Cytokine release syndrome, because nothing precludes them from the treatment. It is obvious to administer compound 42 to any patient with SIRS, including a sub-population of CRS, (VORHAGEN background) because nothing precludes them from the treatment. This teaches claim 32, 35-41 and 44-46, 48.
ESTRADA teaches that its solution or suspension may be administered, preferably orally or nasally, from devices that deliver the formulation in an appropriate manner (paragraph [0960]). This helps teach a feeding tube of claim 47.
ESTRADA does not teach a feeding tube explicitly.
BOULLATA teaches that administering drugs through a gastric feeding tube is a known and commonly used procedures (page 1).
An artisan would have been motivated and expected to use a known technique (gastric feeding tube; BOULLATA) to administer Compound 42 orally via devices that deliver the formulation in an appropriate manner (ESTRADA). This teaches claim 47.
Claim(s) 32, 35-41, and 44-57 are rejected under 35 U.S.C. 103 as being unpatentable over ESTRADA (US PG PUB 2017/0226127) as evidenced by BOSMANN (Bosmann and Ward, “The Inflammatory Response in Sepsis”, Trends Immunol., March 2013) and in view of VORHAGEN (Shimakukuro-Vornhagen et al., “Cytokine release syndrome”, Journal for Immunotherapy of Cancer,2018) and BOULLATA (J. Boullata, “Drug Administration through a Feeding Tube”, OLEY Nutrition Support, September/October 2011) as evidenced by SOMANI (Somani and Choundhary, “Cytokine Storm Assessment in Initial Stages of COVID-19 Along with Recent Emerging Therapeutic Modalities”, September 23, 2022).
SOMANI is relied upon for the beneficial teaching that Cytokine Release Syndrome (CRS) is characterized by clinical presentation of enormous systemic inflammations (page 1 right col). This teaches claim 48.
SOMANI is relied upon for the beneficial teaching that the systemic hyperinflammatory response (i.e. Cytokine Release Syndrome) is shown by an increase in IL-6 (page 1 right col). This teaches claim 49.
SOMANI is relied upon for the beneficial teaching that Cytokine Release Syndrome includes inflammation, which in turn activates innate immune response (page 2 right col). This teaches claims 50-51.
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Chemical properties are inherent to their compounds. See MPEP 2112 (II). Products of identical chemical composition cannot have mutually exclusive properties. A chemical composition, ezetimibe, and its properties, reducing mesangial expansion, are inseparable. See MPEP 2112.01 (II).
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
This teaches claims 52-57.
Conclusion
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 GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
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/G.A.H./ Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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