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 .
The preliminary amendment to the claims of 9/25/24 has been entered.
Claims 30-49 are examined on the merits. No claims are allowed.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/25/24 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser- executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See pages 30, 31 and 45.
Appropriate correction is required.
Terminal Disclaimer
The terminal disclaimer filed on 11/7/25 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent 11339207, 11590112, 11969412 and 12145981 have been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Objections
Claims 31-49 are objected to because of the following informalities: the claims should begin with the article “The” because claims 31-49 depend from claim 30. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) INGENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 30-49 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AJA), first paragraph, because the specification, while being enabling for inhibiting influenza virus infection in vitro by administering effective amounts of Dilmapimod and PH797804. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims as the claims include treating or preventing severe influenza in a human patient an effective amount of any p38 MAP kinase inhibitor (herein referred to as p38 inhibitor), wherein the human patient is not confirmed to be infected with influenza.
Nature of the invention/Breadth of the claims. The claims are drawn to a method of preventing or treating severe influenza in a human patient in need thereof comprising administering to a patient a therapeutically or prophylactically effective amount of a p38 MAP kinase inhibitor. The severe influenza is characterized by hypercytokinemia or hypoxemia or cardiopulmonary insufficiency or lower respiratory tract disorder, breathing difficulty or fever. The amount of p38 inhibitor is effective at inhibiting release of pro-inflammatory mediators/cytokines from endothelial cells/immune cells and a specific p38 inhibitor is UR-13870. The p38 MAP Kinase inhibitor is administered orally or intravenously.
State of the prior art/Predictability of the art. The state of the art does not recognize that administering a p38 inhibitor can achieve prevention of the claimed co-infection or even an infection by one of these pathogens, such as influenza virus. The Centers for Disease and Prevention (CDC.gov) provides guidance towards treating influenza infections. They state that some anti-viral drugs can lessen symptoms and shorten the time “sick”. However, the CDC also states that the best way to prevent seasonal influenza (the most common form of flu) is to receive a flu vaccine, [see attached CDC webpage document]. Furthermore, Borgeling et al. (Journal of Biological Chemistry, 2014, Vol. 289, No. 1, pages 13-27) teach the prophylactic use of an inhibitor of p38 (SB 202190) to protect mice from lethal influenza challenge by suppressing excessive cytokine expression [see abstract and Figure 7].
Working examples. Working examples are provided that test in vitro and ex vivo cells being exposed to influenza A/Perth/16/2009 (H3N2) and Dilmapimod or PH797804. No in vivo tests were conducted in which a p38 inhibitor was administered in order to treat or prevent severe influenza in a human patient or to treat symptoms characteristic of severe influenza.
Guidance in the specification. The specification provides guidance towards using any p38 inhibitor to treat a severe influenza infection in a human subject.
Amount of experimentation necessary. Additional research is required in order to determine how effective administering a p38 inhibitor, such as UR-13870, would be at treating severe influenza infection in a subject since the working examples provided do not carry out a method within the scope of this invention and the state of the art with regard to treating severe influenza in a human patient focuses on seasonal influenza vaccination as the preferred therapeutic.
For the reasons discussed above, it would require undue experimentation for one skilled in the art to use the claimed methods.
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 30, 37, 38, 39, 45 and 49 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.
Claim 30 recites the limitation "the patient" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is suggested that the claim be amended to recite, “the human patient”.
Claim 37 recites, “UR-13870 (Palau Pharma)”, however, the recitation of UR-13870 and “(Palau Pharma)” is indefinite because it is unclear if the recitation of Palau Pharma is further limiting the claim and since UR-13870 is produced by more than one company (Palau Pharma SA and Organon NV) [see “Synapse.patsnap.com” NPL attached herein].
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 38 recites the broad recitation “fever”, and the claim also recites “(a temperature greater then 100oF/38oC)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 38 recites a list of symptoms of influenza, which appear to encompass a Markush grouping, however, the claim does not employ the claim structure of “selected from the group consisting of:”, which therefore places the claimed grouping into an open format that encompasses alternatives not presently claimed. [see MPEP 2173.05(h) I]
Claim 39 recites a list of patient symptoms, which appear to encompass a Markush grouping, however, the claim does not employ the claim structure of “selected from the group consisting of:”, which therefore places the claimed grouping into an open format that encompasses alternatives not presently claimed. [see MPEP 2173.05(h) I]
Claim 45 recites a list of severe influenza characteristics, which appear to encompass a Markush grouping, however, the claim does not employ the claim structure of “selected from the group consisting of:”, which therefore places the claimed grouping into an open format that encompasses alternatives not presently claimed. [see MPEP 2173.05(h) I]
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.
Claims 30-36 and 43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 89, 99-103 and 89 of copending Application No. 18615334 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the method of ‘334 involves administering p38 MAP kinase inhibitors to a human patient infected with influenza virus in order to treat the influenza viral infection and a symptom, such as hypercytokinemia.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN P BLUMEL whose telephone number is (571)272-4960. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on (571) 270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN P BLUMEL/ Primary Examiner, Art Unit 1648
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