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 Application
Applicant’s election without traverse of Linker 5, in the reply filed on 03/18/2026 is acknowledged.
Claims 1, 7, 10, 15-17, and 20-21 have direct references to linkers. Each claim will be examined using the elected linker, linker 5,
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Claims 1-23 are under examination.
Priority
Applicant’s claim for priority to the benefit of U.S. Provisional Patent Application Serial No. 62/024,255, filed on 07/04/2014 is acknowledged.
Claim Objections
Claims 7 and 16 are objected to because of the following informalities: a semicolon missing immediately before the phrase "each of Ra, Rb, Rc…". Appropriate correction is required.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1, 3-4, 6, 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanno, S.; et al. (Kanno, S.; Wu, Y-J. L.; Lee, P. C.; Dodd, S. J.; Williams, M.; Griffith, B. P.; Ho, C. Macrophage Accumulation Associated with Rat Cardiac Allograft Rejection Detected by Magnetic Resonance Imaging With Ultrasmall Superparamagnetic Iron Oxide Particles. Circulation. 2001, 104, 8, 934-938) and Chang, W-H.; et al. (US 2011/0171715 A1, disclosed in the IDS).
Kanno et al. (hereafter referred to as Kanno) is drawn to a method of tracking immune cells (pg 934, col 2, para 2, lines 7-9) in a patient with an organ transplant (title; abstract (lines 2-4), pg 935, col 2, Results, lines 1-2) using a biocompatible magnetic nanoparticles of small size covered with a biocompatible polymer (pg 935, col 2, para 2, lines 6-10).
As to claim 1, Kanno teaches a method of tracking immune cells (pg 934, col 2, para 2, lines 7-9); identifying a patient having a disease associated with an organ (title; abstract (lines 2-4), pg 935, col 2, Results, lines 1-2); providing an aqueous suspension containing biocompatible magnetic nanoparticles (pg 935, col 2, para 2, lines 6-10); with a size less than 1000 nm (abstract (line 4); pg 934, col 2, para 2, lines 1-4; pg 935, col 1, para 1, lines 1-5); biocompatible magnetic nanoparticles each containing a superparamagnetic core that is covered by one or more biocompatible polymers (title; abstract (lines 2-4); pg 934, col 2, para 2, 1-4); administering the aqueous suspension into the blood stream of the patient (pg 935, col 2, para 2, lines 6-10); obtaining a magnetic resonance image of the organ (pg 935, col 2, para 3, lines 1-5; pg 936, Fig 1-2); and presence of hyperintense or hypointense spots in MRI indicates immune response in the patient (pg 936, Figures 1-3; pg 936, col 2, para 2, lines 7-9; pg 937, Fig 4; pg 937, col 1, Discussion, para 1, lines 2-9).
Kanno does not teach a biocompatible polymer containing a polyethylene glycol group, a silane group, and a linker linking, via a covalent bond, the polyethylene glycol group and the silane group.
Chang et al. (hereafter referred to as Chang) is also drawn to a biocompatible magnetic nanoparticle (title; abstract (lines 1-2)) for MRI (para [0004]-[0005]) that are covered with a biocompatible polymer (title; abstract (lines 1-2); para [0005]; formula (I); formula (II); para [0021]).
Regarding a biocompatible polymer containing a polyethylene glycol group, a silane group, and a linker linking, via a covalent bond, the polyethylene glycol group and the silane group, Chang teaches a biocompatible polymer of formula (I) (pg 1, para [0009]; para [0018]; claim 1) and formula (II) (pg 1, para [0011]; pg 2, para [0021]; claim 8) that each contain a polyethylene glycol group, a silane group, and a linker linking, via a covalent bond, the polyethylene glycol group and the silane group.
A person of ordinary skill in the art could have combined the elements as claimed by known methods in Kanno and Chang, 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 3, Chang teaches disease is cancer (pg 1, para [0004]; pg 2, para [0024]).
Chang does not teach transplanted organs.
Kanno teaches transplanted organ (title; abstract (lines 1-17); pg 935, col 1, para 4-5; pg 935, col 2, para 6, lines 1-2).
A person of ordinary skill in the art could have combined the elements as claimed by known methods in Kanno and Chang, 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 4, Kanno teaches the transplanted organ is heart (title; abstract; pg 1, col 2, para 2, lines 1-4) and kidney (pg 937, col 2, para 2, lines 1-4).
As to claim 6, Kanno teaches the transplanted organ is heart (title; abstract; pg 1, col 2, para 2, lines 1-4) and kidney (pg 937, col 2, para 2, lines 1-4) and lymph nodes (pg 934, col 2, para 2, lines 5-9; pg 935, col 1, para 1, lines 5-7).
As to claim 10, Chang teaches an iron oxide superparamagnetic core (pg 2, para [0020]).
Chang teaches a polyethylene glycol group that has 5-1000 oxyethylene units (pg 1, formula (I); pg 1, para [0010], line 2; pg 1, formula (II); pg 1, para [0012], lines 1-2). Chang teaches an oxyethylene unit that fully encompasses the claimed range of 10-200 oxyethylene units. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang teaches a silane group that contains a C1-10 alkylene group (pg 1, formula (I); pg 1, para [0010], lines 2-3; pg 1, formula (II); pg 1, para [0012], line 2); and the elected linker (pg 1, formula (I); pg 1, formula (II)). Chang teaches a silane group that fully encompasses the claimed range for the silane group, C3-C10. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang teaches the linker is a carbonyl moiety of the formula
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(pg 1, formula (I); pg 1, formula (II)).
As to claim 11, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that lies fully within the claimed range of 1-1000nm. In cases where the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 50-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
As to claim 12, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that fully encompasses the claimed range of 15-200 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 120-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
As to claim 13, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that lies fully within the claimed range of 1-1000nm. In cases where the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 50-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
As to claim 14, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that fully encompasses the claimed range of 15-200 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 120-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanno and Chang as applied to claim 1 above, and further in view of Stirrat et al. (Stirrat, C. G.; Newby, D. E.; Robson, J. M. J.; Hansen, M. A. The Use of Superparamagnetic Iron Oxide Nanoparticles to Assess Cardiac Inflammation. Curr. Cardiovasc. Imaging Rep. 2014, 7, 9263).
The teachings of Kanno and Chang as applied in the previous rejection are incorporated in this rejection. Kanno is drawn to a method of tracking immune cells (pg 934, col 2, para 2, lines 7-9) in a patient with an organ transplant (title; abstract (lines 2-4), pg 935, col 2, Results, lines 1-2) using a biocompatible magnetic nanoparticles of small size covered with a biocompatible polymer (pg 935, col 2, para 2, lines 6-10). Chang is also drawn to a biocompatible magnetic nanoparticle (title; abstract (lines 1-2)) for MRI (para [0004]-[0005]) that are covered with a biocompatible polymer (title; abstract (lines 1-2); para [0005]; formula (I); formula (II); para [0021]).
Kanno does not teach T2 or T2* weighted magnetic resonance imaging.
Chang teaches T2 magnetic resonance imaging (pg 3, para [0043], lines 2-3).
Chang does not teach T2* weighted magnetic resonance image.
Stirrat et al. (hereafter referred to as Stirrat) is also drawn to superparamagnetic nanoparticles (title; abstract (lines 1-3); pg 2, Table 1) covered in polymers (pg 1, col 2, para 2, lines 7-11, pg 2, Table 1).
As to claim 2, Stirrat teaches a T2 or T2* weighted magnetic resonance image (pg 2, col 1, para 2, lines 17-20; pg 3, Fig 1) where T2* weighted magnetic resonance imaging is shown to be an improvement (pg 5, col 2, para 3, lines 11-16).
The prior art contained a “base” device (method or product) upon which the claimed invention can be seen as an “improvement”. Stirrat contained a known technique that is applicable to the base device (method, or product). Therefore, a person of ordinary skill in the art would have recognized that applying the known technique of Stirrat with the “base” device (method, or product) of Kanno and Chang would have yielded predictable results and resulted in an improved system. See MPEP 2143(I)(D).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanno and Chang as applied to claims 1, 3-4 above, and further in view of Baio, et al. (Baio, G.; Fabbi, M.; Salvi, S.; Totero, D.; Truini, M.; Ferrini, S.; Neumaier, C. E. Two-Step In Vivo Tumor Targeting by Biotin-Conjugated Antibodies and Superparamagnetic Nanoparticles Assessed by Magnetic Resonance Imaging at 1.5 T. Mol. Imaing Biol., 2010, 12, 305-315).
The teachings of Kanno and Chang as applied in the previous rejections are incorporated in this rejection. Kanno is drawn to a method of tracking immune cells (pg 934, col 2, para 2, lines 7-9) in a patient with an organ transplant (title; abstract (lines 2-4), pg 935, col 2, Results, lines 1-2) using a biocompatible magnetic nanoparticles of small size covered with a biocompatible polymer (pg 935, col 2, para 2, lines 6-10). Chang is also drawn to a biocompatible magnetic nanoparticle (title; abstract (lines 1-2)) for MRI (para [0004]-[0005]) that are covered with a biocompatible polymer (title; abstract (lines 1-2); para [0005]; formula (I); formula (II); para [0021]).
As to claim 5, Kanno teaches imaging of lymph nodes (pg 934, col 2, para 1, lines 1-3).
Kanno does not teach lymphoma.
Chang teaches imaging of cancers (pg 1, para [0004], line 1-3; pg 2, para [0024], col 2, lines 4-6)
Chang does not teach lymphoma.
Baio et al. (hereafter referred to as Baio) is also drawn to superparamagnetic nanoparticles for MRI (title; abstract; pg 307, col 1, para 7; pg 307; col 2, para 4-5).
Baio teaches the cancer is lymphoma (abstract; pg 306, col 2, para 2, lines 1-2; pg 308, col 1, para 1, lines 1-5; pg 308, Fig 1; pg 308, col 2, para 2, lines 1-4; pg 310, Fig 2; pg 310, col 1, para 3, lines 1-6)
A person of ordinary skill in the art could have combined the elements as claimed by known method of Baio with the known methods of Kanno and Chang, 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).
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanno and Chang as applied to claim1, 3-4, and 6 above, and further in view of Acar, H. Y.; et al (US 2005/0260137 A1). \
The teachings of Kanno and Chang as applied in the previous rejections are incorporated in this rejection. Kanno is drawn to a method of tracking immune cells (pg 934, col 2, para 2, lines 7-9) in a patient with an organ transplant (title; abstract (lines 2-4), pg 935, col 2, Results, lines 1-2) using a biocompatible magnetic nanoparticles of small size covered with a biocompatible polymer (pg 935, col 2, para 2, lines 6-10). Chang is also drawn to a biocompatible magnetic nanoparticle (title; abstract (lines 1-2)) for MRI (para [0004]-[0005]) that are covered with a biocompatible polymer (title; abstract (lines 1-2); para [0005]; formula (I); formula (II); para [0021]).
As to claim 7, Kanno teaches iron oxide superparamagnetic core (title; abstract, line 3; pg 935, col 2, para 2, lines 6-10).
Kanno does not teach cobalt oxide, nickel oxide, or combinations thereof.
Chang teaches an iron oxide superparamagnetic core (pg 2, para [0020]); polyethylene glycol group that has 5-1000 oxyethylene units (pg 1, formula (I); pg 1, para [0010], line 2; pg 1, formula (II); pg 1, para [0012], lines 1-2); a silane group that contains a C1-10 alkylene group (pg 1, formula (I); pg 1, para [0010], lines 2-3; pg 1, formula (II); pg 1, para [0012], line 2); and the elected linker (pg 1, formula (I); pg 1, formula (II)).
Chang does not teach cobalt oxide, nickel oxide, or combinations thereof.
Acar, H. Y.; et al. (hereafter referred to as Acar) is also drawn to magnetic nanoparticles (abstract; Fig 3; pg 3, para [0028], lines 9-16; pg 4, para [0036], lines 5-14; claim 35) with a biocompatible polymer shell (abstract; Fig 3; pg 3, para [0030], lines 28-31; pg 4, para [0037], lines 21-22; pg 8, claim 12; pg 9, claim 49; and pg 10, claim 79).
Acar teaches a superparamagnetic core made of iron oxide, cobalt oxide, nickel oxide, or combinations thereof (pg 3, para [0028], lines 9-16; pg 4, para [0036], lines 5-14; claim 35); a polyethylene glycol group and a silane group (pg 3, para [0030], lines 28-31; pg 4, para [0037], lines 21-22; pg 8, claim 12; pg 9, claim 49; and pg 10, claim 79).
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 having 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 8, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that overlaps with the claimed range of 10-1000nm. In such cases, even a slight overlap of ranges establishes a prima facie case of obviousness. See MPEP 2144.05(I).
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 50-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
As to claim 9, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that fully encompasses the claimed range of 15-200 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 120-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
Claim(s) 15-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kanno and Chang as applied to claims 1, 3-4, 6, and 10-14 above, and further in view of Sill, K. (US 2013/0178600 A1).
The teachings of Kanno and Chang as applied in the previous rejections are incorporated in this rejection. Kanno is drawn to a method of tracking immune cells (pg 934, col 2, para 2, lines 7-9) in a patient with an organ transplant (title; abstract (lines 2-4), pg 935, col 2, Results, lines 1-2) using a biocompatible magnetic nanoparticles of small size covered with a biocompatible polymer (pg 935, col 2, para 2, lines 6-10). Chang is also drawn to a biocompatible magnetic nanoparticle (title; abstract (lines 1-2)) for MRI (para [0004]-[0005]) that are covered with a biocompatible polymer (title; abstract (lines 1-2); para [0005]; formula (I); formula (II); para [0021]).
As to claim 15, Chang teaches the superparamagnetic core covered by one or more biocompatible polymers having the claimed formula (pg 1, para [0011], lines 1-4; pg 1, formula (II)) where R is C1-C6 alkyl (pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), aryl (pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), carbonyl group (such as carboxyl; pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), and C1-C10 amine group (pg 2, para [0019], lines 5-6). Chang teaches L is a linker (pg 1, formula (I); pg 1, formula (II)). Chang teaches m is 1 to 10 (pg 1, para [0012], line 2). Chang teaches n is 5 to 1000 (pg 1, para [0012], lines 1-2).
Chang does not teach where R is H.
Chang does not teach where R is C2-C6 alkenyl.
Chang does not teach where R is C2-C6 alkynyl.
Chang does not teach where R is C3-C10 cycloalkyl.
Chang does not teach where R is heterocycloalkyl.
Sill is drawn to poly(ethylene glycol) and its derivatives for attachment for various technological areas, especially in biomedical fields (title; abstract; pg 1, para [0003], lines 1-6), deriviatives ranging from silane-based (pg 4, para [0049]), aliphatic (pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), and other functional groups allowing it to be conjugated to a variety of chemistries (pg 1, para [0007]-[0010]; pg 3, para [0048]-[0053]). Furthermore, Sill identified the need for non-toxic, biocompatible, non-immunogenic, water soluble, adjustable biodistribution, solubility, and need to attach to various biological scaffolds as a design incentive for derivatizing polyethylene glycol (pg 1, para [0003]-[0004]).
Sill teaches PEG where R is H (pg 1, para [0014], line 1), alkenyl (pg 1, para [0014], line 4; pg 3, para [0042]), alkynyl (pg 1, para [0014], line 4; pg 3, para [0042]), cycloalkyl (pg 1, para [0014], line 4; pg 3, para [0042]) all of lengths between 1 and 20 carbons (pg 3, para [0042], line 6-7), and heterocycloalkyl with 3-8 members or 8-10 members (pg 1, para [0014], line 4-9). In each case, Sill teaches R such that the claimed R overlaps or lies fully within the alternatives taught by Sill. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous device (method, or product). The teachings of Sill established that there were design incentives which would have prompted adaptation of the known device (method, or product). The differences between the claimed invention and the prior art were encompassed in known variation or in a principle known in the prior art. Therefore, a person having ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to a person having ordinary skill in the art. See MPEP 2143(I)(F).
As to claim 16, Chang teaches the elected linker (pg 1, formula (I); pg 1, formula (II)).
As to claim 17, Chang teaches the superparamagnetic core covered by one or more biocompatible polymers having the claimed formula (pg 1, para [0011], lines 1-4; pg 1, formula (II)) where R1 is C1-C6 alkyl (pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), aryl (pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), carbonyl group (such as carboxyl; pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), and C1-C10 amine group (pg 2, para [0019], lines 5-6). Chang teaches the linker where R2 is H, which is the elected linker (pg 1, formula (I); pg 1, formula (II)). Chang teaches m is 1 to 10 (pg 1, para [0012], line 2). Chang teaches n is 5 to 1000 (pg 1, para [0012], lines 1-2).
Chang does not teach where R1 is H.
Chang does not teach where R1 is C2-C6 alkenyl.
Chang does not teach where R1 is C2-C6 alkynyl.
Chang does not teach where R1 is C3-C10 cycloalkyl.
Chang does not teach where R1 is heterocycloalkyl.
Sill teaches PEG where R1 is H (pg 1, para [0014], line 1), alkenyl (pg 1, para [0014], line 4; pg 3, para [0042]), alkynyl (pg 1, para [0014], line 4; pg 3, para [0042]), cycloalkyl (pg 1, para [0014], line 4; pg 3, para [0042]) all of lengths between 1 and 20 carbons (pg 3, para [0042], line 6-7), and heterocycloalkyl with 3-8 members or 8-10 members (pg 1, para [0014], line 4-9). In each case, Sill teaches R1 such that the claimed R1 overlaps or lies fully within the alternatives taught by Sill. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous device (method, or product). The teachings of Sill established that there were design incentives which would have prompted adaptation of the known device (method, or product). The differences between the claimed invention and the prior art were encompassed in known variation or in a principle known in the prior art. Therefore, a person having ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to a person having ordinary skill in the art. See MPEP 2143(I)(F).
As to claim 18, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that lies fully within the claimed range of 10-1000nm. In cases where the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 50-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
As to claim 19, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that fully encompasses the claimed range of 15-200 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 120-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
As to claim 20, Kanno teaches the transplanted organ is heart (title; abstract; pg 1, col 2, para 2, lines 1-4) and kidney (pg 937, col 2, para 2, lines 1-4). Kanno teaches the core is a superparamagnetic iron oxide nanoparticle (pg 934, col 2, para 2, lines 1-3)
Kanno does not teach polyethylene glycol group vaing 10 to 200 oxyethylene units.
Kanno does not teach the silane group containing C3-C10 alkylene.
Kanno does not teach the elected linker.
Kanno does not teach magnetic resonance image with a T2 or T2* weighted magnetic resonance image.
Chang teaches a polyethylene glycol group that has 5-1000 oxyethylene units (pg 1, formula (I); pg 1, para [0010], line 2; pg 1, formula (II); pg 1, para [0012], lines 1-2). Chang teaches an oxyethylene unit that fully encompasses the claimed range of 10-200 oxyethylene units. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang teaches a silane group that contains a C1-10 alkylene group (pg 1, formula (I); pg 1, para [0010], lines 2-3; pg 1, formula (II); pg 1, para [0012], line 2); and the elected linker (pg 1, formula (I); pg 1, formula (II)). Chang teaches a silane group that fully encompasses the claimed range for the silane group, C3-C10. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang teaches the linker is a carbonyl moiety of the formula
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191
316
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(pg 1, formula (I); pg 1, formula (II)).
Chang teaches T2 magnetic resonance imaging (pg 3, para [0043], lines 2-3).
Chang does not teach T2* weighted magnetic resonance image.
Stirrat teaches a T2 or T2* weighted magnetic resonance image (pg 2, col 1, para 2, lines 17-20; pg 3, Fig 1).
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 21, Chang teaches the biocompatible polymer having the claimed formula (pg 1, para [0011], lines 1-4; pg 1, formula (II)) where R1 is C1-C6 alkyl (pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), carbonyl group (such as carboxyl; pg 1, para [0010], [0012], [0019] lines 1-2 and 9-12), and C1-C10 amine group (pg 2, para [0019], lines 5-6). Chang teaches the linker where R2 is H, which is the elected linker (pg 1, formula (I); pg 1, formula (II)). Chang teaches m is 1 to 10 (pg 1, para [0012], line 2). Chang teaches n is 5 to 1000 (pg 1, para [0012], lines 1-2). Chang teaches m and n such that the claimed range lies inside the ranges disclosed by the prior art. In such cases, a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang does not teach where R1 is H.
Sill teaches PEG where R1 is H (pg 1, para [0014], line 1).
The scope and content of the prior art, whether in the same field of endeavor as that of the applicant’s invention or a different field of endeavor, included a similar or analogous device (method, or product). The teachings of Sill established that there were design incentives which would have prompted adaptation of the known device (method, or product). The differences between the claimed invention and the prior art were encompassed in known variation or in a principle known in the prior art. Therefore, a person having ordinary skill in the art, in view of the identified design incentives or other market forces, could have implemented the claimed variation of the prior art, and the claimed variation would have been predictable to a person having ordinary skill in the art. See MPEP 2143(I)(F).
As to claim 22, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that lies fully within the claimed range of 10-1000 nm. In cases where the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 50-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
As to claim 23, Chang teaches biocompatible magnetic nanoparticles with a particle size of about 3-500 nm (pg 2, col 2, para [0024], lines 1-2). Chang teaches a particle size range that fully encompasses the claimed range of 15-200 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. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). See MPEP 2144.05(I).
Chang also teaches biocompatible magnetic nanoparticles with a transverse magnetic relaxivity rate of 321.8 (pg 3, para [0043], Table 1). The magnetic relaxivity rate taught by Chang lies fully within the claimed range of 120-400. "If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023). See MPEP 2131.03.
Non-Statutory 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.
Issued Patent No. 8,741,615
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, and 14 of U.S. Patent No. 8,741,615 and the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill presented above. Although the claims at issue are not identical, they are not patentably distinct from each other because they are taught by conflicting claims in issued patent no. 8,741,615.
Instant claim 1 is drawn to a method of tracking immune cells, by identifying a patient with a disease, providing an aqueous suspension containing biocompatible magnetic nanoparticles, where the particles are less than 1000 nm, contain a superparamagnetic core covered by one or more biocompatible polymers containing polyethylene glycol covalently linked to a silane group through a linker, administering the aqueous suspension into the blood stream of the patient, and obtaining a MRI.
Conflicting claim 1 teaches a biocompatible iron oxide nanoparticle, administering it to a patient, covered with one or more biocompatible polymers containing polyethylene glycol covalently linked to a silane group through a linker. Conflicting claim 5 teaches a size less than 1000 nm.
However, the claims of 8,741,615 do not expressly teach the method of tracking immune cells, administering to the blood stream, nor MRI. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 1 of the instant application.
Instant claims 2-6 are not expressly taught. However, they are dependent on a claim that is rendered obvious. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 2-6 of the instant application.
Instant claim 7 is drawn to superparamagnetic core containing iron oxide, cobalt oxide, nickel oxide, or combination thereof, polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group and the elected linker.
Conflicting claim 1 is drawn to a polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker as shown in Formula (II).
However, the claims of 8,741,615 do not expressly teach superparamagnetic core containing iron oxide, cobalt oxide, nickel oxide, or combination thereof. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 7 of the instant application.
Instant claim 8 is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 5 is drawn to a magnetic nanoparticle with a diameter of about 3-500 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 8 of the instant application.
Instant claim 9 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 7 is drawn to a magnetic nanoparticle with a diameter of about 15-200 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 9 of the instant application.
Instant claim 10 is drawn to a superparamagnetic core of iron oxide nanoparticle; the polyethylene glycol group with 10 to 200 oxyethylene units; the silane group containing C3-C10 alkylene; and the elected linker.
Conflicting claim 1 is drawn to a superparamagnetic nanoparticle of iron oxide; polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker as shown in Formula (II).
Instant claim 11 is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 5 is drawn to a magnetic nanoparticle with a diameter of about 3-500 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 11 of the instant application.
Instant claim 12 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 5 is drawn to a magnetic nanoparticle with a diameter of about 3-500 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 12 of the instant application.
Instant claim 13 is drawn to a particle size of 1-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 5 is drawn to a magnetic nanoparticle with a diameter of about 3-500 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 13 of the instant application.
Instant claim 14 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 7 is drawn to a magnetic nanoparticle with a diameter of about 15-200 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 14 of the instant application.
Instant claim 15 is drawn to a biocompatible polymer with the claimed formula where R is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; L is the elected linker; m is 1 to 10; and n is 5 to 1000.
Conflicting claim 1 is drawn to a polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker as shown in Formula (II).
Conflicting claim 14 is drawn to R, where R is alkyl, aryl, carboxyl, or amino.
However, the claims of 8,741,615 do not expressly teach the specific R substituents H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 15 of the instant application.
Instant claim 16 is drawn to the elected linker.
Conflicting claims 1 and 14 teach the elected linker.
Instant claim 17 is drawn to a superparamagnetic core covered by one or more biocompatible polymers of the claimed formula in which R1 is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 1 to 10; and n is 5 to 1000.
Conflicting claim 1 is drawn to a superparamagnetic core covered by biocompatible polymers where the polymer is a polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker as shown in Formula (II).
Conflicting claim 14 is drawn to R, where R is alkyl, aryl, carboxyl, or amino.
However, the claims of 8,741,615 do not expressly teach the specific R substituents H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 17 of the instant application.
Instant claim 18, is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 5 is drawn to a magnetic nanoparticle with a diameter of about 3-500 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 18 of the instant application.
Instant claim 19 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 7 is drawn to a magnetic nanoparticle with a diameter of about 15-200 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 19 of the instant application.
Instant claim 20 is drawn to a disease is a rejection of a transplanted heart or kidney; the superparamagnetic core is iron oxide nanoparticle; the polyethylene glycol group has 10 to 200 oxyethylene units; the silane group contains C3-C10 alkylene; the linker is the elected linker; and the magnetic resonance image is T2 or T2* weighted magnetic resonance image.
Conflicting claim 1 is drawn to a superparamagnetic core of iron oxide nanoparticle; polyethylene glycol group having 5-1000 oxyethylene units; a silane group containing a C1-C10 alkylene group; and the elected linker as shown in Formula (II).
However, the claims of 8,741,615 do not expressly teach the rejection, or the MRI technique. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 20 of the instant application.
Instant claim 21 is drawn to R1 is H, C1-C6 alkyl, C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 3 to 10; and n is 10 to 200.
Conflicting claim 14 is to a polymer with R1 as alkyl, aryl, carboxyl, or amino. And shows formula (II) which is the elected linker where R2 is H.
However, the claims of 8,741,615 do not expressly teach the specific R substituents H, C1-C6 alkyl, a C1-C10 carbonyl group, or a C1-C10 amine group. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 17 of the instant application.
Instant claim 22 is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 5 is drawn to a magnetic nanoparticle with a diameter of about 3-500 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 22 of the instant application.
Instant claim 23 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 7 is drawn to a magnetic nanoparticle with a diameter of about 15-200 nm.
However, the claims of 8,741,615 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 23 of the instant application.
Issued Patent No. 9,492,399
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 9,492,399 and the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill presented above. Although the claims at issue are not identical, they are not patentably distinct from each other because they are taught by conflicting claims in issued patent no. 9,492.399.
Instant claim 1 is drawn to a method of tracking immune cells, by identifying a patient with a disease, providing an aqueous suspension containing biocompatible magnetic nanoparticles, where the particles are less than 1000 nm, contain a superparamagnetic core covered by one or more biocompatible polymers containing polyethylene glycol covalently linked to a silane group through a linker, administering the aqueous suspension into the blood stream of the patient, and obtaining a MRI.
Conflicting claim 1 teaches a biocompatible iron oxide nanoparticle, administering it to a patient, covered with one or more biocompatible polymers containing polyethylene glycol covalently linked to a silane group through a linker. Conflicting claim 4 teaches a size less than 1000 nm.
However, the claims of 9,492,399 do not expressly teach the method of tracking immune cells, administering to the blood stream, nor MRI. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 1 of the instant application.
Instant claims 2-6 are not expressly taught. However, they are dependent on a claim that is rendered obvious. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 2-6 of the instant application.
Instant claim 7 is drawn to superparamagnetic core containing iron oxide, cobalt oxide, nickel oxide, or combination thereof, polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group and the elected linker.
Conflicting claim 2 is drawn to a polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker.
However, the claims of 9,492,399 do not expressly teach superparamagnetic core containing iron oxide, cobalt oxide, nickel oxide, or combination thereof. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 7 of the instant application.
Instant claim 8 is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 3 and 6, 8, 13, and 16 are drawn to a magnetic nanoparticle with a diameter of about 3-1000 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 8 of the instant application.
Instant claim 9 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 4 and 7, 9, 14, and 17 are drawn to a magnetic nanoparticle with a diameter of 15-200 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 9 of the instant application.
Instant claim 10 is drawn to a superparamagnetic core of iron oxide nanoparticle; the polyethylene glycol group with 10 to 200 oxyethylene units; the silane group containing C3-C10 alkylene; and the elected linker.
Conflicting claim 2 is drawn to a superparamagnetic nanoparticle of iron oxide; polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker.
Instant claim 11 is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 3, 6, 8, 13, and 16 are drawn to a magnetic nanoparticle with a diameter of about 3-1000 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 11 of the instant application.
Instant claim 12 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 4, 7, 9, 14, and 17 are drawn to a magnetic nanoparticle with a diameter of 15-200nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 12 of the instant application.
Instant claim 13 is drawn to a particle size of 1-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 3, 6, 8, 13, and 16 are drawn to a magnetic nanoparticle with a diameter of about 3-1000 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 13 of the instant application.
Instant claim 14 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 4, 7, 9, 14, and 17 are drawn to a magnetic nanoparticle with a diameter of about 15-200 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kannoa, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 14 of the instant application.
Instant claim 15 is drawn to a biocompatible polymer with the claimed formula where R is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; L is the elected linker; m is 1 to 10; and n is 5 to 1000.
Conflicting claim 12 is drawn to a polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker; and where R is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group.
Instant claim 16 is drawn to the elected linker.
Conflicting claims 1, 2, 5, 10, 11, 12, and 15 teach the elected linker.
Instant claim 17 is drawn to a superparamagnetic core covered by one or more biocompatible polymers of the claimed formula in which R1 is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 1 to 10; and n is 5 to 1000.
Conflicting claim 12 is drawn to a superparamagnetic core covered by one or more biocompatible polymers of the claimed formula in which R1 is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 1 to 10; and n is 5 to 1000.
Instant claim 18, is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 3, 6, 8, 13, and 16 are drawn to a magnetic nanoparticle with a diameter of about 3-1000 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 18 of the instant application.
Instant claim 19 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 4, 7, 9, 14, and 17 are drawn to a magnetic nanoparticle with a diameter of about 15-200 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 19 of the instant application.
Instant claim 20 is drawn to a disease is a rejection of a transplanted heart or kidney; the superparamagnetic core is iron oxide nanoparticle; the polyethylene glycol group has 10 to 200 oxyethylene units; the silane group contains C3-C10 alkylene; the linker is the elected linker; and the magnetic resonance image is T2 or T2* weighted magnetic resonance image.
Conflicting claim 2 is drawn to a superparamagnetic core of iron oxide nanoparticle; polyethylene glycol group having 5-1000 oxyethylene units; a silane group containing a C1-C10 alkylene group; and the elected linker as shown in Formula (II).
However, the claims of 9,492,399 do not expressly teach the rejection, or the MRI technique. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 20 of the instant application.
Instant claim 21 is drawn to R1 is H, C1-C6 alkyl, C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 3 to 10; and n is 10 to 200.
Conflicting claim 15 is drawn to R1 is H, C1-C6 alkyl, C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 3 to 10; and n is 10 to 200.
Instant claim 22 is drawn to a particle size of 10-1000 nm and a transverse magnetic relaxivity rate of 50 to 400.
Conflicting claim 3, 6, and 8 are drawn to a magnetic nanoparticle with a diameter of about 3-1000 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 50 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 22 of the instant application.
Instant claim 23 is drawn to a particle size of 15-200 nm and a transverse relaxivity rate of 120 to 400.
Conflicting claim 4, 7, and 9 are drawn to a magnetic nanoparticle with a diameter of about 15-2500 nm.
However, the claims of 9,492,399 do not expressly teach the transverse magnetic relaxivity rate of 120 to 400. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 23 of the instant application.
Issued Patent No. 12,268,756
Claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, and 9 of U.S. Patent No. 12,268,756. and the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill presented above. Although the claims at issue are not identical, they are not patentably distinct from each other because they are taught by conflicting claims in issued patent no. 12,268,756.
Instant claim 1 is drawn to a method of tracking immune cells, by identifying a patient with a disease, providing an aqueous suspension containing biocompatible magnetic nanoparticles, where the particles are less than 1000 nm, contain a superparamagnetic core covered by one or more biocompatible polymers containing polyethylene glycol covalently linked to a silane group through a linker, administering the aqueous suspension into the blood stream of the patient, and obtaining a MRI.
Conflicting claim 1 teaches a biocompatible iron oxide nanoparticle with oleic acid, covered with one or more biocompatible polymers containing polyethylene glycol covalently linked to a silane group through a linker.
However, the claims of 12,268,756 do not expressly teach the method of tracking immune cells, administering to the blood stream, size, no oleic acid, nor MRI. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 1 of the instant application.
Instant claims 2-6, 8-9, 11-14, 18-19, 22-23 are not expressly taught. However, they are dependent on a claim that is rendered obvious. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 2-6 of the instant application.
Instant claim 7 is drawn to superparamagnetic core containing iron oxide, cobalt oxide, nickel oxide, or combination thereof, polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group and the elected linker.
Conflicting claim 1 is drawn to a polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker.
However, the claims of 12,268,756 do not expressly teach superparamagnetic core containing iron oxide, cobalt oxide, nickel oxide, or combination thereof. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 7 of the instant application.
Instant claim 10 is drawn to a superparamagnetic core of iron oxide nanoparticle; the polyethylene glycol group with 10 to 200 oxyethylene units; the silane group containing C3-C10 alkylene; and the elected linker.
Conflicting claim 1 is drawn to a superparamagnetic nanoparticle of iron oxide; polyethylene glycol group having 5-1000 oxyethylene units, a silane group containing a C1-C10 alkylene group, and the elected linker.
Instant claim 15 is drawn to a biocompatible polymer with the claimed formula where R is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; L is the elected linker; m is 1 to 10; and n is 5 to 1000.
Conflicting claim 1 is drawn to biocompatible polymer with the claimed formula where R is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; L is the elected linker; m is 1 to 10; and n is 5 to 1000.
Instant claim 16 is drawn to the elected linker.
Conflicting claims 1, 3-6, and 9 teach the elected linker.
Instant claim 17 is drawn to a superparamagnetic core covered by one or more biocompatible polymers of the claimed formula in which R1 is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 1 to 10; and n is 5 to 1000.
Conflicting claim 1 is drawn to a superparamagnetic core covered by one or more biocompatible polymers of the claimed formula in which R1 is H, C1-C6 alkyl, C2C6 alkenyl, C2-C6 alkynyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, aryl, heteroaryl, a C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 1 to 10; and n is 5 to 1000.
Instant claim 20 is drawn to a disease is a rejection of a transplanted heart or kidney; the superparamagnetic core is iron oxide nanoparticle; the polyethylene glycol group has 10 to 200 oxyethylene units; the silane group contains C3-C10 alkylene; the linker is the elected linker; and the magnetic resonance image is T2 or T2* weighted magnetic resonance image.
Conflicting claims 1 and 4 are drawn to a superparamagnetic core of iron oxide nanoparticle; polyethylene glycol group having 5-1000 oxyethylene units; a silane group containing a C1-C10 alkylene group; and the elected linker.
However, the claims of 12,268,756 do not expressly teach the rejection, or the MRI technique. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 20 of the instant application.
Instant claim 21 is drawn to R1 is H, C1-C6 alkyl, C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 3 to 10; and n is 10 to 200.
Conflicting claims 1, 3-6, and 9 are drawn to R1 is H, C1-C6 alkyl, C1-C10 carbonyl group, or a C1-C10 amine group; R2 is H so as to meet the elected linker; m is 1 to 10; and n is 5 to 1000.
However, the claims of 12,268,756 do not expressly teach the same values of m and n. As noted in the current rejections above, the combined teachings of Kanno, Chang, Stirrat, Baio, Acar, and Sill render obvious claims 20 of the instant application.
Conclusion
No Claims allowed.
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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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