Prosecution Insights
Last updated: April 19, 2026
Application No. 18/276,114

PHARMACEUTICAL COMPOSITION FOR PREVENTING CYTOKINE STORM

Non-Final OA §101§102§112§DP
Filed
Aug 07, 2023
Examiner
OLSON, ANDREA STEFFEL
Art Unit
1693
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Kinki University
OA Round
1 (Non-Final)
62%
Grant Probability
Moderate
1-2
OA Rounds
3y 4m
To Grant
50%
With Interview

Examiner Intelligence

Grants 62% of resolved cases
62%
Career Allow Rate
868 granted / 1397 resolved
+2.1% vs TC avg
Minimal -12% lift
Without
With
+-12.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
64 currently pending
Career history
1461
Total Applications
across all art units

Statute-Specific Performance

§101
2.0%
-38.0% vs TC avg
§103
37.3%
-2.7% vs TC avg
§102
18.6%
-21.4% vs TC avg
§112
21.2%
-18.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1397 resolved cases

Office Action

§101 §102 §112 §DP
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 This application is a national stage application of PCT/JP2022/005709, filed February 14, 2022, which claims priority to foreign application JP2021-021955, filed February 15, 2021. Claims 1-5 are pending in this application and examined on the merits herein. Applicant’s preliminary amendment submitted August 7, 2023, is acknowledged wherein Claim 1 is amended. Priority This application claims priority to foreign application JP2021-021955, filed February 15, 2021. However, the priority document is in Japanese without a certified English translation. Therefore the effective filing date of present claims 1-5 is seen to be the filing date of PCT/JP2022/005709, February 14, 2022. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claim 5 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 5 depends from claim 1, which claims a pharmaceutical composition for a particular intended use . Dependent claim 5 claims “An agent containing at least one compound of formulas (1) to (4) as described in claim 1.” Every element of this claim as already present in claim 1. Furthermore the preamble defining the claimed subject matter as “an agent” does not define any property of said composition not already present in a pharmaceutical composition. Furthermore the specification does not particularly define this term in a manner that would lead to it being interpreted more narrowly. For these reasons claim 5 fails to further limit the scope of claim 1.” Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. 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 of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Claims 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim(s) recite(s) a pharmaceutical composition for inhibiting cytokine storms, comprising as an active ingredient a compound selected from a list including compound ((1): This compound (1,3,6,7-tetra-hydroxy-xanthone) is a natural product present for example in Guttiferae species, as described by Jantan et al. (Reference included with PTO-892, see for example p. 1092 table 1 compound (3)) It is also naturally present in the plant H. beanii , as described by Ma et al. (Reference included with PTO-892, see for example p. 2 second paragraph and figure 1 compound (22)) This judicial exception is not integrated into a practical application because , while the preambles of claims 1-3 recite certain properties of the claimed compositions, including inhibiting cytokine storm, inhibiting TNF-alpha, and inhibiting IL-6 . According to MPEP 2016.04(d)(2), “ in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration [integrating a judicial exception into a practical application] , the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. ” Additionally, “ a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used. ” Therefore the mere presence of a preamble suggesting a possible use of a product of nature for a particular purpose does not integrate the product of nature into a practical application. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because any description of the compound as part of a “pharmaceutical composition,” “processed food,” or “agent” as described in the present claims amount to merely well-understood, conventional, routine activity that does not amount to an inventive concept . 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 1-5 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nishida et al . ( PCT international publication WO2020/130102, Reference included with PTO-1449, English machine translation included with PTO-892) Independent claim 1 claims a pharmaceutical composition for inhibiting cytokine storms comprising an active ingredient having any of formulae (1)-(4). Since the claim is directed to a pharmaceutical composition rather than to a process of actually treating a disease, this limitation is seen to be merely an intended use that toes not impose further structural limitations on the claim scope. Dependent claims 2-5 claim the same composition with further preambles describing its intended use for inhibiting specific cytokines or as a “processed food” or “agent”. Nishida et al. discloses a composition for improving autoimmune disease comprising a substance represented by the formula: which is the same compound (2) recited in present claim 1. (p. 16 paragraphs 46-47) In a further embodiment the composition can comprise : which is compound (1) from present claim 1. Furthermore the specific intended uses recited in present claims 1-3 do not provide any further structural limits for the compositions being claimed, and the “agent” claimed in claim 5 is seen to have no further limitations compared to the composition of base claim 1. Regarding claim 4, Nishida et al. further discloses preparing these compositions as foods, including processed foods. Therefore Nishida et al. anticipates the present claims. Furthermore as discussed previously a certified English translation of priority document JP2021-021955 has not been provided. Therefore the effective filing date of present claims 1-5 is seen to be the filing date of PCT/JP2022/005709, February 14, 2022, and the publication of Nishida et al. cannot be regarded as falling within the 1-year grace period under 35 USC 102(b)(1). Claims 1-5 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Rio et al . (US pre-grant publication 2018/0021397, cited in PTO-892) Independent claim 1 claims a pharmaceutical composition for inhibiting cytokine storms comprising an active ingredient having any of formulae (1)-(4). Since the claim is directed to a pharmaceutical composition rather than to a process of actually treating a disease, this limitation is seen to be merely an intended use that toes not impose further structural limitations on the claim scope. Dependent claims 2-5 claim the same composition with further preambles describing its intended use for inhibiting specific cytokines or as a “processed food” or “agent”. Rio et al. discloses an herbal extract containing either mangiferin or norathyriol. (p. 2 paragraph 17) According to PUBCHEM CID 5281656 , (Reference included with PTO-892) norathyriol is the compound (1) recited in present claim 1. Furthermore the specific intended uses recited in present claims 1-3 do not provide any further structural limits for the compositions being claimed, and the “agent” claimed in claim 5 is seen to have no further limitations compared to the composition of base claim 1. Regarding claim 4, Rio et al. discloses preparing the composition s in various forms including for example non-dairy creamers, spreads, snack bars, candies, or cookies, all of which are processed foods. For these reasons Nishida et al. anticipates the present claims. Double Patenting The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer . Claim s 1- 3 and 5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 19/100332 (reference application , unpublished, cited in PTO-892, herein referred to as ‘332 ). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘332 anticipate the present claims . Specifically, claim 1 of ‘332 claims a compound selected from a number of structures including (1) and (2) which are the same as structures (2) and (1) in present claim 1. Furthermore the specific intended uses recited in present claims 1-3 do not provide any further structural limits for the compositions being claimed, and the “agent” claimed in claim 5 is seen to have no further limitations compared to the composition of base claim 1. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 16 of copending Application No. 18/268434 (reference application, US pre-grant publication 2024 / 0124430 , cited in PTO-892, herein referred to as ‘434). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘434 anticipate the present claims. Specifically, claim 1 of ‘434 claims a compound selected from a number of structures including (5), (8), and (10) which are the same as structures (3) and (4) in present claim 1. Claim 2 of ‘434 claims a pharmaceutical composition comprising said compounds. Furthermore the specific intended uses recited in present claims 1-3 do not provide any further structural limits for the compositions being claimed, and the “agent” claimed in claim 5 is seen to have no further limitations compared to the composition of base claim 1. Claim 16 claims processed food compositions comprising the compounds, similarly to present claim 4. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion No claims are allowed in this action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT ANDREA OLSON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9051 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 6am-3:00pm . 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 Scarlett Y Goon can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-270-5241 . 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. /ANDREA OLSON/ Primary Examiner, Art Unit 1693 12/17/2025
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Prosecution Timeline

Aug 07, 2023
Application Filed
Dec 17, 2025
Non-Final Rejection — §101, §102, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
62%
Grant Probability
50%
With Interview (-12.1%)
3y 4m
Median Time to Grant
Low
PTA Risk
Based on 1397 resolved cases by this examiner. Grant probability derived from career allow rate.

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