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
Claims 1 – 6, 9 and 13 – 14 are pending.
Claims 1 – 2 are rejected.
Claims 3 – 6, 9 and 13 – 14 are withdrawn.
Noncompliant Amendment
The Amendment filed on December 17, 2025 is not compliant with the requirements of 37 CFR 1.121(c)(2) which states in part that “All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of "currently amended," and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims. The text of any added subject matter must be shown by underlining the added text”. Claim 3 recites the limitation “A method of treating a microbial disease, comprising administering an effective amount of a compound of claim 1 or 2 to a patient in need thereof”. See, page 3. Claim 14 recites the limitation “A liposomal formulation comprising (a) a lipid and (b) a compound of claim 1 or a compound of claim 2”. See, page 5.
However, each of the limitations in claim 3 and 14 is a newly recited limitation but does not indicate proper marking (underlining the added text). Amendment is required to underline all added text in the claims to indicate the changes that have been made relative to the immediate prior version of the claims. Since Applicant’s reply appears bona fide, the amendment has been entered; however, appropriate correction is required in replying to this Office Action.
Election/ Restriction
Claims 3 – 6, 9 and 13 – 14 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Claims 3 – 6, 9 and 13 – 14 have been amended to recite a new invention of a method of treating a microbial disease, comprising administering an effective amount of a compound of claim 1 or 2 to a patient in need thereof. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 3 – 6, 9 and 13 – 14 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Applicant’s Remarks
Applicant’s remarks filed on December 17, 2025 have been fully considered.
The objections to claims 1 – 2 are withdrawn in view of the amendment to insert a period (.) at the end of each claim.
The rejection under 35 U.S.C. 112(b) of claims 1 – 2 (claims 3 – 6, 9 and 13 – 14 are withdrawn, and claims 7 – 8 and 10 – 12 are cancelled) as being indefinite is withdrawn in view of the amendment to delete the terms “based on” in each of the claims.
The rejection under 35 U.S.C. 112(b) of claims 3 – 6, 9 and 13 – 14 (said claims are withdrawn, and claims 7 – 8 and 10 – 12 are cancelled) as being indefinite is withdrawn in view of the amendment to delete the term “derivative” in each of the claims.
The rejection under 35 U.S.C. 112(b) of claim 13 (said claim is withdrawn) as being indefinite is withdrawn in view of the amendment to delete the exemplary limitations “e.g.”.
The rejection under 35 U.S.C. 112(d) of claims 3 – 6, 9 and 13 – 14 (said claims are withdrawn, and claims 7 – 8 and 10 – 12 are cancelled) as being of improper dependent form is withdrawn in view of the amendment to delete the limitation “or a pharmaceutically acceptable derivative thereof”.
The rejection under 35 U.S.C. 102(a)(1) of claim 1 (claims 3 – 6, 9 and 13 – 14 are withdrawn, and claims 7 – 8 and 10 – 12 are cancelled) as being anticipated by Senge et al., Photodiagnosis and Photodynamic Therapy (2012), 9: pp. 170-179 is withdrawn in view of the amendment to delete compounds 1 and 2.
Examination: Applicant’s amendments necessitate extending the search. In accordance with MPEP §803.02, examination of the Markush-type claim has been extended to the scope of compound of formula 3 (claim 1), and tetrapyrrole zinc complex of formula 4 (claim 2).
However, a 2nd Non-Final action is issued in order to address the rejection under 102(a)(1) (not previously addressed) of claim 2 as being anticipated by Hunter et al., J. Am. Chem. Soc. 2011, 133, pp. 582-594.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 21, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objection
Claim 1 is objected to because of the following informality:
Line 3 of the claim: The structure of the tetrapyrrole compound of formula 3 is
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. The structure is incomplete. According to the claims dated February 20, 2024, the structure of the tetrapyrrole compound of formula 3 is
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. In order to overcome the objection, Applicant may amend to replace the structure presented above. Appropriate correction is required.
For examination purposes, the structure of the tetrapyrrole compound of formula 3 is considered as
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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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Langer et al. WO 2011/071968 A2.
Langer et al. teach compound mTHPD-OH. See, e.g., page 10. Compound mTHPD-OH is presented below:
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The prior art anticipates the instant claims as presented below:
Claim 1, directed to a tetrapyrrole compound of formula 3:
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Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hunter et al., J. Am. Chem. Soc., 2011, 133, pp. 582-594.
Hunter et al. teach compound P1a. See, e.g., page 584, Figure 3. Compound P1a is presented below:
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The prior art anticipates the instant claims as presented below:
Claim 2, directed to a tetrapyrrole zinc complex of formula 4:
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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