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 .
Status of the Claims
The present office action is in response to the October 2, 2025 Amendment and Request for Reconsideration After Non-Final Rejection.
Claims 16-19, 21-39 and 41-42 are pending and claims 16-19, 21-39 and 41-42 are amended and claims 1-15, 20 and 40 are cancelled in the above identified application.
Priority
The present application U.S. Appln. Ser. No.: 17/995,327, Filed: October 3, 2022 is a 371 Nat.’ l Stage Entry of WO 2021/198504 A1 (i.e., PCT/EP2021/058787, Intern.’l Filing Date: April 2, 2021, Intern.’l Pub. Date: October 7, 2021), which claims foreign priority to 21157974.3, Filed: February 18, 2021 and LU101724, Filed: April 2, 2020.
Typographical Error
For the record, the Examiner notes typographical errors in rejection headers in the July 1, 2025 Non-Final Office Action (i.e., cancelled claim nos. inadvertently were identified in those headers, instead correct rejected claim nos., were identified within body of each rejection and Applicants note this In written response and properly respond to each rejection based on the correct rejected claims).
The correct headers should have stated:
Claims 16, 18-19, 22-23, 28-30, 32-33, 35, and 38, 40-42 (i.e., instead of cancelled claims 1-4 and 7-9) 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 Applicants), regards as the invention.
Claims 16-42 (i.e., instead of cancelled claims 1-19) are rejected under 35 U.S.C. 112(a) rejected for lack of enablement .
The instant action proceeds forwards in light of rejections based on correct claim numbers as properly addressed by Applicants in the Amendment After Non-Final Rejection
WITHDRAWN REJECTIONS
[1] Rejection of claims 16, 18, 19, 22, 23, 28, 29, 30, 32, 33, , 35, and 38, 41-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd para., 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the Applicants), regards as the invention is WITHDRAWN in part and maintained in part (i.e., as specifically noted below).
[2] Rejection of claims 16-42 under 35 U.S.C. 112(a) for lack of enablement is WITHDRAWN based on Applicants amendments and in favor of new rejections necessitated by amendment as set forth below.
[3] Rejection of claim 16 under 35 U.S.C. 102(a)(1) as being anticipated by WO 2006/065722 A2 to Advanced Inhalation Res Inc., Intern.’l Filing Date: September 7, 2018, Intern.’l Pub. Date: March 14, 2019 (“WO ’722 Appln.”) is WITHDRAWN.
[4] Rejection of claims 16-42 under 35 U.S.C. 103 as being obvious over WO 2006/065722 A2 to Advanced Inhalation Res Inc., Intern.’l Filing Date: September 7, 2018, Intern.’l Pub. Date: March 14, 2019 (“WO ’722 Appln.”), alone, in view of or in combination with WO 2019/048590 A1 to Jencluster GmbH, Intern.’l Filing Date: December 13, 2005, Intern.’l Pub. Date: June 22, 2006 (“WO ’590 Appln.” ; i.e., which corresp. to US Pat. No.: 11,440,872; 371 to Inflamed Pharma GmbH (i.e., assigned to Jencluster GmbH; Filing Date: March 5, 2020; Issued: September 13, 2022) is WITHDRAWN.
MAINTAINED REJECTIONS/AMENDED AS NECESSITATED BY AMENDMENT
Claims 18 and 41-42 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd para., 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 Applicants), regards as the invention are MAINTAINED and Amended As per Applicants claim amendments.
Claim 41 lacks clarity and is vague, ambiguous, indefinite for recitation of the phrase “the subject does not require intensive medical treatment” given that is a dependent claim associated with the method of treating atypical pneumonia caused by SARS-CoV-2 of claim 18;
i.e., e.g., such that the aforementioned phrase renders the metes and bounds of the claimed invention indeterminate: it is not apparent what “constitutes intensive medical treatment” generally means, why a subject being treated for the indicated disease (as per method 18) would not require intensive medical treatment and moreover, the instant specification also does not define what the aforementioned phrase actually means? Deletion of this claim is recommended.
[B][2] Claims 19 and 21-38, respectively, dependent from rejected independent claim 18 (i.e., noted supra directed to a method of an anti-viral treatment of atypical pneumonia caused by SARS-Co-V- 2) fails to define the metes and bound of the claimed invention, because it incorporates limitations associated with a method claim for making an amine-carbonic acid solution, but does not define what specific terms are, which include what defines a “base”, “solution” at least one solvent” associated with each step associated with the secondary preparation method invention, which renders each of identified claims 19 and 21-38 vague, ambiguous, indefinite, lacking clarity, etc..
Applicants are requested to make adapt the suggested changes to claim 18 and/or amend by combining each of the claims 19 and 21-38 into a single claim to define all the elements associated with the administered composition into a single claim for the treatment method claim 18 to address this rejection accordingly.
Claim 38 is rejected for recitation of the term “the lyophilization” which lacks antecedent basis in the instant claim and any other preceding claim; i.e.,e.g., because Lyophilization is the process (freeze-drying) of removing water from a substance by freezing it and then sublimating the ice under vacuum, while lyophilized describes the state or condition of the product after this process—a dry, stable, porous powder that can be easily reconstituted, such as certain antibiotics or vaccines. So, lyophilization is the action, and lyophilized is the adjective for the resulting freeze-dried material, emphasizing the product's preserved state and rapid reabsorption properties. Appropriate correction is required accordingly.
[C] DOUBLE PATENTING REJECTIONS ARE MAINTAINED
Claims 16-42 are provisionally rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claim 1-20 of U.S. Pat. Appln. No. 17/863,250. Filed: July 12, 2022.
Claims 16-42 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 11,440,872 B2, 371 Date Filed: March 5, 2020 (PCT Filing Date: September 7, 2018), Issued: September 13, 2022.
APPLICANTS ARGUMENTS
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EXAMINER’S COMMENTS
The Examiner notes that Two (2) Double Patenting Rejections were issued in the July 1, 2025, not one.
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 a non-statutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Terminal Disclaimers are requested to be filed accordingly.
REJECTIONS REITERATED IN ENTIRETY
Provisional Double Patenting Rejection Over U.S. Pat. Appln. No. 17/863,250.
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Double Patenting Rejection Over U.S. Patent No. 11,440,872 B2,
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NEW REJECTIONS NECESSITATED BY AMENDMENT
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 19 is rejected under 35 U.S.C. § 112(d), or pre-AIA 35 U.S.C. § 112, 4th paragraph, as being in improper dependent form. A dependent claim must incorporate all limitations of the preceding claim and further limit the subject matter
Claim 18 was amended to specifically and solely claim a method of antiviral treatment of atypical pneumonia caused by SARS-CoV-2. Claim 19 attempts to broaden this scope by listing various causes of atypical pneumonia, including those that are bacterial or fungal in origin. These conditions fall outside the specific antiviral scope of claim 18. Since Claim 19 broadens, rather than further limits, the scope of the parent claim, it fails the statutory requirement for proper dependency.
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.
CONCLUSION
Applicants amendment necessitated the new ground(s) of rejection presented in this Office action. There will be no rejoinder and examination of withdrawn claims in the instant matter. 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 GRACE C HSU whose telephone number is (571) 270-1689. The Examiner can normally be reached Monday-Friday 7:30 am - 6 pm.
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If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Jeffrey Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.C.H./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624