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 Application
Applicant’s cancellation of claim(s) 1-14 in the claim set filed on 01/24/2024 is acknowledged.
Applicant’s addition of new claim(s) 15-29 in the claim set filed on 01/24/2024 is acknowledged.
Claims 15-29 are under examination.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to because of the following reasons:
Figures 4A, 7D, 7E, 8C lettering is blurry and difficult to read.
Figures 5A and B contain small lettering which is also blurry and difficult to read.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Abstract
The abstract of the disclosure does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Claim Interpretation
Claim 15 recites “wherein each of said coated nanoparticles of iron oxide is coated by a polymer”. The examiner notes that the method of making the particles of claim 15 in claim 20, only allows for the iron oxide, an initial coating, and a final matrix of polyserotonine or polycatecholamine. The examiner interprets the phrase to mean, the coating of the said coated nanoparticles is a polymer which is different from polycathecolamine or polyserotonine. Therefore, any art that reads on iron oxide nanoparticles that are coated with any polymer besides polycathecolamine or polyserotonine, and is embedded in a matrix of polycathecolamine or polyserotonine reads on this claim.
Claim 20 recites in step c) the phrase, “obtain final particles of a desired size”. The examiner notes that claim 20 is dependent on claim 15 where the size of the particle is between 200 nm and 2000 nm. Therefore, the phrase “desired size” is interpreted as between 200 nm and 2000 nm.
Claim 21 recites a product by process. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See MPEP 2113(I). Therefore, any prior art that reads on the particles of claim 15 in a suspension of claim 19 reads on the particles of claim 21.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 15, 17-23, and 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monsalve, A.; et al. (Monsalve, A.; Dobson, J. P., US 2015/0306220 A1) and Wu, M. et al. (Wu, M.; Zhang, D.; Zeng, Y.; Wu, L.; Liu, X.; Liu, J. Nanocluster of superparamagnetic iron oxide nanoparticles coated with poly(dopamine) for magnetic field-targeting, highly sensitive MRI and photothermal cancer therapy. Nanotechnology, 2015, 26, 115102-115104, as cited in the IDS filed on 01/24/2024).
Monsalve, A.; et al. (hereafter referred to as Monsalve) is drawn to conjugating a TFG-β growth factor to a magnetic particle (title; abstract) where the magnetic nanoparticle is iron oxide (pg 2, claims 3, 6, 9, and 11) is coated in a first polymer (claim 3, 6, 11, and 14; pg 3, claim 26) and optionally contains a second polymer (pg 3, claim 26) and where the polymer coated magnetic nanoparticle is conjugated to a protein (pg 2, claim 1 and 14; pg 3, claim 26-27).
As to claim 15, Monsalve teaches a particle having an hydrodynamic diameter in the nanometer to micrometer range. This range overlaps with the claimed range between 200 nm and 2000 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Monsalve teaches the particle is iron oxide (pg 2, para [0008, lines 6-8; claims 6, 9, and 26) and where the iron oxide particles are coated with a polymer different from polycathecolamine (claims 3, 6, 9, 11, 14, 15, and 26) and that the coated iron nanoparticles are coated in a second biocompatible polymer (claim 26).
Monsalve does not teach that the biocompatible polymer is polycathecolamine or polyserotonine.
Wu, M.; et al. (hereafter referred to as Wu) is drawn to a iron oxide nanoparticle coated with a polydopamine (title; abstract). Wu teaches synthesis of particles (pg 2, col 2, para 3) and in vivo imaging using the coated particles (pg 4, col 1, para 1).
Wu teaches that polydopamine is a biocompatible polymer (pg 2, col 1, para 3, lines 1-10).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
As to claim 17, Wu teaches the polycathecolamine is polydopamine (pg 2, col 1, para 3, lines 1-10). As to claim 18, Monsalve teaches the polymer is a dextran or a polyethylene glycol (claims 3, 14, 15, and 26).
As to claim 19, Wu teaches a suspension comprising a plurality of particles (pg 9; col 1, para 2, lines 5-6; pg 9, col 2, lines 10-16).
As to claim 20, Wu teaches step a) (pg 3, col 1, para 1, lines 1-5), step b) (pg 3, col 1, para 1, lines 5-6), step c) (pg 3, col 1, para 1, liens 5-6; pg 3, col 1, para 2, lines 1-2), and step d) (pg 3, col 1, para 1, lines 5-6).
As to claim 21, Monsalve teaches a particle having an hydrodynamic diameter in the nanometer to micrometer range. This range overlaps with the claimed range between 200 nm and 2000 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Monsalve teaches the particle is iron oxide (pg 2, para [0008, lines 6-8; claims 6, 9, and 26) and where the iron oxide particles are coated with a polymer different from polycathecolamine (claims 3, 6, 9, 11, 14, 15, and 26) and that the coated iron nanoparticles are coated in a second biocompatible polymer (claim 26).
Monsalve does not teach that the biocompatible polymer is polycathecolamine or polyserotonine.
Monsalve does not teach a suspension.
Regarding the biocompatible polymer, Wu teaches that polydopamine is a biocompatible polymer (pg 2, col 1, para 3, lines 1-10).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding the suspension, Wu teaches a suspension comprising a plurality of particles (pg 9; col 1, para 2, lines 5-6; pg 9, col 2, lines 10-16).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 22, Monsalve teaches a conjugate or a molecule comprising free amine or thiol groups (claims 1-15, and 26).
As to claim 23, Monsalve teaches the molecule is a protein (abstract; pg 1, para [0003]; claims 1-15, and 26).
As to claim 27, Monsalve teaches a particle having an hydrodynamic diameter in the nanometer to micrometer range. This range overlaps with the claimed range between 200 nm and 2000 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). Monsalve teaches the particle is iron oxide (pg 2, para [0008, lines 6-8; claims 6, 9, and 26) and where the iron oxide particles are coated with a polymer different from polycathecolamine (claims 3, 6, 9, 11, 14, 15, and 26) and that the coated iron nanoparticles are coated in a second biocompatible polymer (claim 26). Monsalve teaches a conjugate or a molecule comprising free amine or thiol groups (claims 1-15, and 26).
Monsalve does not teach that the biocompatible polymer is polycathecolamine or polyserotonine.
Monsalve does not teach a suspension.
Regarding the biocompatible polymer, Wu teaches that polydopamine is a biocompatible polymer (pg 2, col 1, para 3, lines 1-10).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Regarding the suspension, Wu teaches a suspension comprising a plurality of particles (pg 9; col 1, para 2, lines 5-6; pg 9, col 2, lines 10-16).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 28, Monsalve teaches a conjugate or a molecule comprising free amine or thiol groups (claims 1-15, and 26).
As to claim 29, Monsalve teaches dextran (claims 14, 15, and 26).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monsalve and Wu in further view of Lee, C.; et al. (Lee, C.; Jeon, S. L.; Chae, M. K.; Cho, J-H.; Hang, E. J. US 2011/0165086 A1). The teachings of Monsalve and Wu as applied in the previous rejections are incorporated in this rejection.
As to claim 16, Monsalve teaches the particle is an iron oxide (claim 3).
Monsalve does not teach the iron oxide is Fe2O3, Fe3O4, or a mixture thereof.
Lee, C.; et al. (hereafter referred to as Lee) is drawn to iron oxide particles coated in a polymer for use in imaging methods (title; abstract). Lee teaches a method for preparing (pg 4, para [0029]-[0030]; claim 3), coating (pg 4, para [0031]-[0032]claim 4), and suspending (claim 5).
Lee teaches the iron oxide may be Fe2O3 or Fe3O4 (pg 2, para [0020]; pg 5, para [0041]; claim 9; claim 10).
The prior art contained a device (method, product, etc.) which differed from the claimed device by the substitution of some components (step, element, etc.) with other components. The substituted components and their functions were known in the art. Therefore, a person of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable. See MPEP 2143(I)(B).
Claim(s) 24-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monsalve and Wu in further view of Johnston, K. P.; et al. (Johnston, K. P.; Ma, L. L.; Feldman, M. D.; Milner, T. E.; Sokolov, K. V.; Rowe, J.; Tam, J.; Emelianov, S.; Travis, K.; Murthy A. K. US 2013/0023714 A1). The teachings of Monsalve and Wu as applied in the previous rejections are incorporated in this rejection.
As to claim 24, Wu teaches the use of the coated iron oxide particles for imaging (pg 7, col 1; pg 8, Fig 5).
Wu does not teach an in vivo method.
Johnston, K. P.; et al. (hereafter referred to as Johnston) is drawn to iron oxide nanoparticles coated in stabilizers (title; abstract) where the stabilizers can be dextran, polyethylene glycol, or a biocompatible polymer (claim 21) for use in medical and imaging (claim 16).
Johnston teaches administering to the patient a composition containing the particles and imaging the patient (claim 80).
A person of ordinary skill in the art could have combined the elements as claimed by known methods, and that in combination, each element merely performs the same function as it does separately. Therefore, a person of ordinary skill in the art would have recognized that the results of the combination were predictable. See MPEP 2143(I)(A).
As to claim 25, Johnston teaches the medical imaging is MRI (claim 16; claim 52).
As to claim 26, Johnston teaches the particles are used as contrast agents (pg 7, para [0094], line 9-10; pg 9, para [0111], lines 1-2; pg 11, para [0125], lines 19-21).
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Copending Application No. 18/291,677
Claims 15-29 are provisionally rejected on the ground of nonstatutory double patenting as
being unpatentable over claims 1-3 and 5-14 of copending Application No. 18/291,677 in view of
Monsalve, Wu, Lee, and Johnston.
This is a provisional nonstatutory double patenting rejection.
The instant claims are drawn to iron oxide nanoparticles coated with dextran or polyethylene glycol and this coated nanoparticle is embedded in a polycathecolamine or polyserotonine; where the suspension is made by polymerizing catecholamine or serotonine around coated nanoparticles; conjugating the particle to a molecule with a molecule with free amine or thiols or radiolabelled metal; and taking an image by administering the compositon and monitoring using MRI, MPI, or PET.
The conflicting claims are drawn to iron oxide nanoparticles coated with polydopamine and embedded in polycathecolamines or polyserotonine. The suspension is made by polymerizing the catecholamine or serotonine around the coated nanoparticles, and conjugating the particles to a molecule with free amine or thiols or radiolabelled metal. And the conflicting claims are drawn to administering the composition to a patient and monitoring using MRI, MPI, or PET.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evan M Lewoczko whose telephone number is (571)272-9830. The examiner can normally be reached Monday-Friday 9-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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