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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
This application is a 371 of PCT/EP2021/068694 filed 07/06/2021.
This application also claims foreign priority to GERMANY DE102020208448.3 filed 07/06/2020.
Claims 1-11, 13, 15, 17, 19-24 of the instant application are afforded the effective filing date of 07/06/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/04/2023 has been considered by the examiner and initialed copies of the IDS are included with the mailing of this office action.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 and 19-24, in the reply filed on 11/21/2025 is acknowledged.
Applicant also elected formula (1a) from claim 5:
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as the species of compound according to formula (I).
The elected species reads on claims 1-2, 4-11, and 19-23.
It is noted that the method of claim 24 was inadvertently included in Group I in the Restriction Requirement dated 10/15/2025. As shown in the preliminary amendments dated 02/09/2023, method of claim 24 is dependent from method of claim 17, in which claim 17 was included in method claims of Group II. Thus, claim 24 is herein corrected to be included in the method claims of Group II, and thereby will be withdrawn along with method claims 13, 15, and 17, as being drawn to a nonelected invention.
Claims 3, 13, 15, 17, and 24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and group/invention, respectively, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/21/2025.
Status of the Claims
Claims 1-11, 13, 15, 17, 19-24 are pending in this instant application, of which claims 3, 13, 15, 17, and 24 are withdrawn at this time being as being drawn to a nonelected species and group/invention, respectively.
Applicant elected formula (1a) from claim 5:
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as the species of compound according to formula (I).
Claims 1-2, 4-11, and 19-23 are examined herein on the merits for patentability.
Claim Objections
Claim 1 is objected to because of the following informalities: it is suggested that all the dashes (-) (see dashes under “spacer molecule”) be removed from claim 1. It is noted that [w]here a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation, 37 CFR 1.75(i). See MPEP §608.01(m). Appropriate correction is required.
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.
Claim(s) 1, 2, 4-6, 8-11, 19, and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruiz-Hernández et al (Polymer Chemistry, 2014, 5: 1674-1681; cited in IDS filed 01/04/2023).
Regarding claims 1, 2, 4-6, 10, 19, and 22-23, Ruiz-Hernández teaches doxorubicin-prodrug loaded in mPEG-b-p(HPMAmLac2-co-AzEMA) micelles (pg-micelles) having the following structure:
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(Abstract; Introduction; pages 1675-1680; Fig(s) 2-4). It is noted that Ruiz-Hernández teaches the doxorubicin-prodrug loaded within mPEG-b-p(HPMAmLac2-co-AzEMA) micelle and provided Figures showing the doxorubicin-prodrug is within the micelle, thereby meeting the claimed “encapsulated within said polymeric micelle.”
Ruiz-Hernández further teaches the doxorubicin-prodrug loaded in the mPEG-b-p(HPMAmLac2-co-AzEMA) micelles can be:
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or
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(pages 1677-1678; Fig(s) 2-4).
Regarding claims 8, 9 and 21, as discussed above, Ruiz-Hernández teaches the drug loaded in the micelle is doxorubicin, thereby meeting the claimed hydrophilic drug molecule.
Regarding claim 11, Ruiz-Hernández teaches an intravenous composition containing a diluent (PBS) and the doxorubicin-prodrug loaded in mPEG-b-p(HPMAmLac2-co-AzEMA) micelles (page 1675).
As a result, the aforementioned teachings from Ruiz-Hernández are anticipatory to claims 1, 2, 4-6, 8-11, 19, and 21-23 of the instant invention.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-2, 4-11, and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ruiz-Hernández et al (Polymer Chemistry, 2014, 5: 1674-1681; cited in IDS filed 01/04/2023), and further in view of Lin et al (Abstracts/Journal of Controlled release, 2015, 213: e48-e49).
The polymeric micelles and pharmaceutical composition of claims 1, 2, 4-6, 8-11, 19, and 21-23, respectively, are discussed above.
However, Ruiz-Hernández does not expressly teach platinum compound of claims 7 and 20.
Regarding the platinum compound of claims 7 and 20, Lin teaches mPEG-b-PLG micelles loaded with doxorubicin and cisplatin, and said micelles loaded with the dual drugs (cisplatin and doxorubicin) enabled enhanced (synergistic) therapeutic efficacy, as well as, the cisplatin also stabilized doxorubicin loaded in the micelles (page e48, bottom to right column through page e49, left column; and Fig. 1). Lin teaches the cisplatin (CDDP) is conjugated to the carbonyl groups through coordination bond (page e49, left column).
It would have been obvious to one of ordinary skill in the art to modify the doxorubicin-prodrug of Ruiz-Hernández such that cisplatin is additionally linked to the carbonyl group as depicted as follows:
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, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Lin provided the guidance to do so by teaching that cisplatin can be loaded with doxorubicin in polymeric micelles by conjugating cisplatin to the carbonyl groups via coordination interaction, and such interaction between the cisplatin and carbonyl groups not only improved stability of the micelles but also enabled synergistic therapeutic efficacy such as enhanced anticancer effect (Lin: page e49, left column). Thus, an ordinary artisan seeking to improved stability of the micelles, as well as, provide a combination therapy that enabled a synergistic anticancer effect, would have looked to modify the doxorubicin-prodrug of Ruiz-Hernández such that cisplatin is additionally linked to the carbonyl group (as shown above), and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613