DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed on 04/07/2026 has been entered. Claims 2, 19, and 21 are cancelled. Claim 22 is new. Claims 1, 3-18, 20, and 22 are pending in this application and are currently under examination.
Priority
This application is a 371 of PCT/EP2021/062293 filed on 05/10/2021 and claims foreign priority of GERMANY 102020112603.4 filed on 05/10/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Withdrawn Claim Objections/Rejections
The objection of claims 1, 3-10, 13, 16, 17, and 20 because of incorrect recitation, as set forth on pages 3 to 4 of the Non-Final Rejection mailed on 10/09/2025, is withdrawn in view of amended claims.
The objection of claim 1 because of non-enclosed reference characters within parentheses, as set forth on page 4 of the Non-Final Rejection mailed on 10/09/2025, is withdrawn in view of amended claim.
The rejection of claims 1-18 and 20 under 35 U.S.C. 112(a), as set forth on pages 5-8 of the Non-Final Rejection mailed on 10/09/2025, is withdrawn in view of amended claim 1 and cancelled claim 2. Claims 3-18 and 20 depend from claim 1.
The rejection of claims 1-18 and 20 under 35 U.S.C. 112(b), as set forth on pages 8 to 9 of the Non-Final Rejection mailed on 10/09/2025, is withdrawn in view of amended claims 1, 6, 10, 12, 16, 18, and 20, and cancelled claim 2. Claims 3-5, 7-9, 11, 13-15, and 17 depend from claim 1.
New (necessitated by amendment) Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, change the incorrect recitation “comprising greater than or equal to 0.01 % by weight of the at least one compatible solute” (last line) to “in an amount of greater than or equal to 0.01 % by weight” to be consistent with dependent claim 15 and because the “by weight of the at least one compatible solute” means “the at least one compatible solute” is the denominator. Appropriate correction is required.
New (necessitated by amendment) Claim Rejections - 35 USC § 112
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 15-18 and 20 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 pre-AIA the applicant regards as the invention. Claims 16-18 and 20 depend from claim 15.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections. See MPEP § 2172.01. The omitted structural cooperative relationships are: Claim 15 recites “in an amount of greater than or equal to 0.0001 % by weight” (lines 2 to 3), which is broader than the “greater than or equal to 0.01 % by weight” in the preceding claim 1.
New (necessitated by amendment)/Claim Rejections - 35 USC § 102/103
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-18, 20, and 22 remain or are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Turner et al. (US 2011/0000480, Jan. 6, 2011, hereinafter referred to as Turner ‘480).
With regard to structural limitations “a method comprising administering to a patient (or who has a chronic respiratory disease, elected) in need of treating a disease caused by a ss(+)RNA virus of the Coronaviridae family (or the genus Betacoronavirus; or SARS-CoV-1, elected) a composition comprising at least one compatible solute or solute mixture with a water-binding capacity of greater than or equal to 7 mol/mol H2O/solute (or mannosylglycerate (Firoin), mannosylglyceramide (Firoin-A), ectoine (elected), or formula I; or in combination with other anti-viral compounds; or in an amount of greater than or equal to 0.01 % by weight (or less than or equal to 70 % by weight; or in a liquid form of spray, aerosols or inhalants suitable for use with a nebulizer or respirator, or in combination with infusion; or to be inhaled via the mouth and/or nose)” (claims 1, 3-5, 13-18, 20, and 22):
Turner ‘480 disclosed treatment of Severe Acute Respiratory Syndrome (SARS), Family: Coronaviridae. SARS has recently emerged in the human population as a fatal respiratory disease. A newly discovered Coronavirus, SCV, has been identified as the primary cause of SARS. SARS patients have been treated empirically with a combination of Ribavirin, Oseltamivir, antibiotics and corticosteroids, with mixed results. Treatment with recombinant human interferon (Alfacon R) has shown clinical promise. Groups of 10 mice were administered 50 µl of Ad5-IFNα (murine, 106 PFU) by intranasal (IN) once at 14, 7, 5, or 3 days pre-virus exposure (PVE). In addition, groups of 10 mice were administered 50 µl of Ad5-IFNα (murine, 106 PFU or 105 PFU) IN one time at 6, 12, 24 hours post virus exposure. Treatment with Ad5-IFNα (murine) resulted in complete protection of all animals in the treatment groups. The route of Ad5-IFNα exposure was by intranasal (IN) to simulate respiratory mucosal surface delivery—a proposed route of administration in humans. In a preferred embodiment, the excipient is one that is capable of stabilizing the IFN-encoding delivery vehicle (e.g., the Ad5-IFN delivery vehicle) for an extended period of time at room temperature with a loss of less than 20% of the viral titer or biological activity. Non-limiting examples of such excipients include, e.g., trehalose, sorbitol. sucrose, mannitol, glycine, CaCl2, hydroxyectoine (=
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), ectoine, firoin, firoin A and gelatine. In yet other embodiments, the excipient, which is present in the composition in an amount in the range of from 1% to 90% by weight (e.g., in an amount in the range of from 5% to 30% by weight). In still other embodiments, the composition can be formulated for aerosolized delivery and can be admixed with a pharmaceutically acceptable liquid to form the liquid or gel (page 39/52, [0213-0215 and 0204]; page 15/52, [0012-0014]). This composition can be administered to a subject either prior to viral exposure or within 48 hours of exposure. The antihistamine helps to reduce any nasal congestion, e.g., stuffed or blocked nasal passages, caused by viral infection or rhinitis, thereby maximizing the distribution of the Ad5-IFN and neuraminidase inhibitor and their absorption by the epithelium of the upper and/or lower respiratory tract (page 38/52, [0200]). Mechanical devices designed for pulmonary and/or nasal delivery of the compositions include nebulizers, metered dose inhalers, and powder inhalers. Parenteral administration includes intra-arterial, intravenous, intraperitoneal, subcutaneous, and intramuscular administration. The preferred method of administration can vary depending on various factors (e.g., the components of the composition being administered and the severity of the condition being treated). (page 35/52, [0164]; page 19/52, [0040]).
Thus, these teachings of Turner ‘480 anticipate Applicant’s claims 1, 3-18, 20, and 22 because (a) a solute as 5% to 30% by weight excipient including hydroxiectoin, ectoin, firoin, and firoin A is included in the Ad5-IFNα composition, (b) the SARS identified before filing of Turner ‘480 in 2010 is SARS-CoV-1, and (c) the recited limitations in claims 6-12 and the “accumulates around a receptor for binding by ss(+)RNA virus of the Coronaviridae family to human cells and shields the receptor with a hydration shell” in claim 22 are either properties of solute or consequence after administering the solute to a patient having a SARS infection. The teachings of Turner ‘480 meet all structural limitations of claimed method and thus would achieve the same intended results of claims 6-12 and 22. In an alternative, skilled artisan would follow the teachings of Turner ‘480 to select specific excipient(s), including hydroxiectoin, ectoin, firoin, and firoin A, for stabilizing anti-coronavirus compound for treating a disease caused by coronavirus infection.
Applicant’s Argument/Remarks filed on 04/07/2026 have been fully considered. Applicant argued “Turner generically discloses ectoine and hydroxyectoine… may be included in a formulation such as inhalation formulations as an excipient… ectoine is in no way disclosed or suggested as an active ingredient. The active ingredient of Turner is a vector encoding an interferon… there is no disclosure or suggestion in Turner of ectoine or hydroxyectoine having an effect against viruses or acting against the receptor. There is also no disclosure or suggestion of ectoine or hydroxyectoine reducing or inhibiting the penetration of the cell by the virus” (p. 10, para. 5; p. 11, para. 1 to 2).
In response, these arguments are found not persuasive because of the following reasons. The amended “as an active ingredient” in claim 1 is not specifically defined and would encompass any compound that carries pharmaceutical activity. The solute of 5% to 30% by weight excipient including hydroxiectoin, ectoin, firoin, and firoin A of Turner ‘480 meets structural limitation and would carry the pharmaceutical activities, required by claims 6-12 and 22, and biological properties or consequences of the solute argued by the Applicant above. To overcome the above rejection, Applicant is advised to include additional structural limitation or active step that is not taught or suggested by the current reference. Any After-Final amendment may not be entered if new issue arises and/or extensive search is required.
Conclusion
No claims are allowed.
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 YIH-HORNG SHIAO whose telephone number is (571)272-7135. The examiner can normally be reached Mon-Thur, 08:30 am to 07:00 pm EST.
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/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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