DETAILED ACTION
Preliminary Amendment filed on 01/27/2023 is acknowledged. Claims 1-15 are pending in the application and are considered on merits.
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 .
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boros et al. (EJNMMI Radiopharmacy and Chemistry, 2018, IDS) (Boros).
Regarding claim 1, Boros teaches a method for labeling an agent, the method comprising:
(i) a step of chelating a non-radioactive substance (natGa3+) by a chelating agent (DOTA) having a reactive group (carboxylic group) (Fig. 1, page 3, par 1), and
(ii) a step of binding the chelating agent that chelated the non-radioactive substance in step (i) to the agent (fibrin-binding peptides, (FBP2, FBP3)) via the reactive group (in the DOTA linker) (Fig. 1),
the method being for use in the evaluation of pharmacokinetics (abstract).
Regarding claim 2, Boros teaches that wherein the non-radioactive substance is a metal (Ga) (Fig. 1, page 3, par 1).
Regarding claim 3, Boros teaches that wherein the non-radioactive substance is lithium, beryllium, sodium, magnesium, aluminum, potassium, calcium, scandium, titanium, vanadium, chromium, manganese, iron, cobalt, nickel, copper, zinc, gallium, rubidium, strontium, yttrium, zirconium, niobium, molybdenum, ruthenium, rhodium, palladium, silver, cadmium, indium, tin, cesium, barium, lanthanum, cerium, praseodymium, neodymium, samarium, europium, gadolinium, terbium, dysprosium, holmium, erbium, thulium, ytterbium, lutetium, hafnium, tantalum, tungsten, rhenium, osmium, iridium, platinum, gold, mercury, thallium, lead, bismuth, or thorium (Fig. 1, page 3).
Regarding claim 4, Boros teaches that wherein the chelating agent (DOTA) having a reactive group is a chelating agent having an amino group or a carboxyl group as a coordinating group (Fig. 1).
Regarding claim 5, Boros teaches that wherein the chelating agent having a reactive group is a chelating agent having a reactive group introduced into any compound selected from DOTA, EDTA, HEDTA, DHEDDA, 1,3-PDTA, DTPA, TTHA, NTA, gluconic acid, HIMDA, ASDA, NTMP, HEDP, tetrasodium 3-hydroxy-2,2'-iminodisuccinate, and porphyrin (Fig. 1, abstract).
Regarding claim 6, Boros teaches that wherein the agent is an antibody, a peptide compound (FBP2), a cell, or a nucleic acid (Fig. 1, page 3, par 1).
Regarding claim 7, Boros teaches that wherein the reactive group is a group capable of forming a chemical bond by reacting with an amino group or a thiol group (Fig. 1).
Regarding claim 8, Boros teaches that a method for measuring the pharmacokinetics of an agent, the method comprising:
(i) a step of labeling the agent with a non-radioactive substance by the method according to claim 1 (Fig. 1, page 3, par 1),
(ii) a step of administering the agent labeled in step (i) to a non-human animal (rats) (abstract, page 4, par 4), and
(iii) a step of collecting a biological sample from the non-human animal after administration of the agent in step (ii) and measuring the content of the non-radioactive substance in the biological sample (page 4, par 4).
Regarding claim 9, Boros teaches that wherein in step (i), two or more agents are labeled with different non-radioactive substances (Ga, In) (page 4, par 4),
and in step (ii), the two or more agents labeled in step (i) are administered to a single nonhuman animal (page 4, par 4).
Regarding claim 10, Boros teaches that wherein the content of the nonradioactive substance is measured by mass spectrometry (page 5, par 0).
Regarding claim 11, Boros teaches that wherein the mass spectrometry is plasma ionization mass spectrometry, electron ionization (El) mass spectrometry, chemical ionization (Cl) mass spectrometry, atmospheric pressure chemical ionization (APCI) mass spectrometry, electrospray ionization (ESI) mass spectrometry, matrix-assisted laser desorption/ionization (MALDI) mass spectrometry, laser desorption mass spectrometry (LDMS), secondary ion mass spectrometry (SIMS), spark source mass spectrometry (SSMS), or thermal ionization mass spectrometry (TIMS) (page 5, par 0).
Regarding claim 12, Boros teaches that wherein the mass spectrometry is plasma ionization mass spectrometry (page 5, par 0).
Regarding claim 13, Boros teaches that wherein the non-human animal is a monkey, miniature pig, rat, mouse, rabbit, dog, or guinea pig (page 4, par 4).
Regarding claim 14, Boros teaches that wherein the administration of the agent in step (ii) is intravenous administration (i.v.), subcutaneous administration (s.c.), peroral administration (p.o.), intraperitoneal administration (i.p.), intramuscular administration (i.m.), intratumoral administration (i.t.), transpulmonary administration, or intranasal administration (page 4, par 4).
Regarding claim 15, Boros teaches a method for screening agents having a desired pharmacokinetics, the method comprising:
(i) a step of measuring the pharmacokinetics of two or more candidate agents by the method according to claim 8 (page 4, par 4, page 5, par 0), and
(ii) a step of comparing the pharmacokinetics of the candidate agents measured in step (i) and
selecting an agent exhibiting the desired pharmacokinetics (page 8, par 4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOYUN R XU, Ph. D. whose telephone number is (571)270-5560. The examiner can normally be reached M-F 8am-5pm.
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/XIAOYUN R XU, Ph.D./ Primary Examiner, Art Unit 1797