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 .
Restriction
Applicant’s election of Group I in the restriction requirement mailed 2/13/2026 is acknowledged. Applicant in their reply pointed to the examiner’s attention that there was a discrepancy in the order of groups. To clarify the record, a corrected version of the restriction requirement appears below, with correction in the order of groups, the order as presented below should be the order referenced in future correspondences.
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted:
Group I, claims 1-13 and 15-20, drawn to a compound of Formula I.
Group II, claims 21-22, drawn to a nanoparticle.
Group III, claims 30, drawn to a method of delivering a drug.
Group IV, claims 32, drawn to a method of treating a disease.
Group V, claim 36, drawn to method of imaging.
The species listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: The common technical feature of the above groups is a compound of Formula I. This element cannot be a special technical feature under PCT Rule 13.2 because it is not novel. US20200009069 to Luo (IDS filed 3/20/2023) teaches the present compound (R¹)m-D¹-L¹-PEG-L²-D²-(R²)ₙ
wherein: each R¹ is independently a peptide, 1,2-dihydroxy compound, or boronic acid derivative (paragraph 75; claims 1 and 16;
each R² is independently cholic acid or a cholic acid derivative (paragraph 75);
D¹ and D² are each independently a dendritic polymer having a single focal point group,
and a plurality of branched monomer units, each branched monomer unit is a diamino carboxylic acid, a dihydroxy carboxylic acid or a hydroxyl amino carboxylic acid (paragraph 75);
L¹ and L² are each independently a bond or a linker linked to the focal point group of the
dendritic polymer (paragraph 76), PEG is a polyethylene glycol (PEG) polymer having a molecular weight of 1-100 kDa (paragraph 189)
Since Applicant’s inventions do not contribute a special technical feature when viewed over the prior art they do not have a single general inventive concept and so lack unity of invention.
Applicant’s election of Group I is acknowledged.
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 1-13 and 15-20 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims recite the word “derivative.” It’s unclear how far removed the structure of a compound can be from a parent compound and still be considered a “derivative” and not an entirely different compound all together. Further regarding claim 2, which depends from claim 1, there is insufficient basis for the term “wherein each R1 is… sugar compound, glucose, or glucose derivative” in claim 1 as “sugar compound, glucose, or glucose derivative” are not disclosed in claim 1. Further regrading claim 3 whicuh depends from claim 1, there is insufficient basis for the recitation“angipep-2… or cellobioise” as claim 1 from which claim 3 depends does not recite these as possible embodiments of the invention. Similarly, those embodiments of R1 recited in claim 6-7, which depend from claim 1, “wherein each R1 is independently a 3-carboxy-5-nitrophenylboronic acid, 4-carboxyphenylboronic acid, 3-carboxyphenylboronic acid, 2-carboxyphenylboronic acid, 4-(hydroxymethyl)phenylboronic acid, 5-bromo-3-carboxyphenylboronic acid, 2-chloro-4-carboxyphenylboronic acid, 2-chloro-5- carboxyphenylboronic acid, 2-methoxy-5-carboxyphenylboronic acid, 2-carboxy-5-pyridineboronic acid, 6-carboxy-2-fluoropyridine-3-boronic acid, 5-carboxy-2-fluoropyridine-3-boronic acid, 4-carboxy-3-fluorophenylboronic acid, or 4-(bromomethyl)phenylboronic acid” (claim 6) and R1 is independently 4-carboxyphenylboronic acid (claim 7) are outside the scope of claim 1 from which these claims depend, and therefore claims 6-7 also lack sufficient antecedent basis for these terms. Claim 8-9 recite the compound of claim 1, wherein each R2 is independently cholic acid, (3a, 5~, 7a, 12a)-7, 12-dihydroxy-3-(2,3-dihydroxy-l-propoxy)-cholicacid (CA-4OH), (3a, 5~, 7a, 12a)-7-hydroxy-3,12-di(2,3-dihydroxy-l-propoxy)-cholic acid
(CA-5OH), or (3a, 5~, 7a, 12a)-7, 12-dihydroxy-3-(3-amino-2-hydroxy-l-propoxy)-cholic acid
(CA-3OH-NH2)” (claim 8) and R2 is cholic acid (claim 9) of claim 1, which are outside the scope of claim 1, and therefore the recitation has insufficient antecedent basis in claim 1. Claims 10-11 recite the compound of laim 1, wherein each X is independently 2,3-diamino propanoic acid, 2,4-diaminobutanoic acid, 2,5-diaminopentanoic acid (omithine), 2,6-diaminohexanoic acid (lysine), (2-Aminoethyl)-cysteine, 3-amino-2-aminomethyl propanoic acid, 3-amino-2-aminomethyl-2-methyl propanoic acid, 4-amino-2-(2-aminoethyl) butyric acid and 5-amino-2-(3-aminopropyl) pentanoic acid (claim 9) and “lysine” (claim 10), which are outside the scope of claim 1 which recites “X;
each branched monomer unit X is a diamino carboxylic acid, a dihydroxy carboxylic acid or a hydroxyl amino carboxylic acid;
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-13 and 15-20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US20200009069 to Luo (IDS filed 3/20/2023). Luo teaches the present compound (R¹)m-D¹-L¹-PEG-L²-D²-(R²)ₙ wherein: each R¹ is independently a peptide, 1,2-dihydroxy compound, or boronic acid derivative (paragraph 75; claims 1 and 16; each R² is independently cholic acid or a cholic acid derivative (paragraph 75); D¹ and D² are each independently a dendritic polymer having a single focal point group, and a plurality of branched monomer units, each branched monomer unit is a diamino carboxylic acid, a dihydroxy carboxylic acid or a hydroxyl amino carboxylic acid (paragraph 75); L¹ and L² are each independently a bond or a linker linked to the focal point group of the dendritic polymer (paragraph 76), PEG is a polyethylene glycol (PEG) polymer having a molecular weight of 1-100 kDa (paragraph 189) (paragraphs 3 and 8-9; claims 1 and 6). This anticipates the presently claimed structures.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2019/0112423 A1 to Lam (document already in record). Lam teaches a compound of formula I wherein each R2 is independently cholic acid or a cholic acid derivative; L2 is a bond or a linker linked to the focal point group of the dendritic polymer; PEG is a polyethylene glycol (PEG) polymer having a molecular weight of 1-100 KDa; n is 8 (figure 21).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
June 24, 2026
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