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
Claims 1-24 are under examination.
Specification
The disclosure is objected to because of the following informalities: the drawings are blurry and difficult to read.
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 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) 1-4 and 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gassensmith, J. J.; et al., US 2023/0001396 A1.
Gassensmith, J. J.; et al. (hereafter referred to as Gassensmith) is drawn to pharmaceutical compositions comprising a therapeutic, a MOF, and an encapsulating polymer (title; abstract). Gassensmith teaches the MOF atoms may be any of their isotopes (pg 3, para [0048]) and the metal may include an alpha-emitter (pg 9, para [0086], lines 1-4 and 10). Gassensmith teaches that the polymer may be a biocompatible polyester (pg 20, para [0160], lines 9-11; claim 1; claim 21).
As to claim 1, Gassensmith teaches a biocompatible composition (pg 20, para [0160], line 9-11) with a metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3) and a carrier encapsulating the metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3). Gassensmith teaches the metal may be a radioisotope (pg 9, para [0086], lines 9-10).
A person of ordinary skill in the art would have had a reasonable expectation of success in combining these elements to create the biocompatible composition since they are all taught in the reference. The skilled artisan would have been motivated to use the radioisotope in the biocompatible composition for any radioisotope-based imaging or therapy.
As to claim 2, Gassensmith teaches a radionuclide-containing core (pg 9, para [0086], lines 9-10) has a diameter of 389.3-795.5 nm (pg 21, para [0178], lines 8-9). This is within the claimed range of less than 1 µm. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. See MPEP 2131.03(I). However, since the independent claim is made obvious over the prior art, instant claim 2 is also made obvious since it contains all the limitations of instant claim 1.
A person of ordinary skill in the art would have had a reasonable expectation of success in using sizes in the range of less than 1 um since values within that range are taught in the prior art. The skilled artisan would have been motivated to have sizes less than 1 µm for stability and for biocompatibility.
As to claim 3, Gassensmith teaches a radionuclide-containing core (pg 9, para [0086], lines 9-10) has a diameter of 389.3-795.5 nm (pg 21, para [0178], lines 8-9). This is within the claimed range of 50-900nm. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. See MPEP 2131.03(I). However, since the independent claim is made obvious over the prior art, instant claim 3 is also made obvious since it contains all the limitations of instant claim 1.
A person of ordinary skill in the art would have had a reasonable expectation of success in using sizes in the range of less than 50-900 nm since values within that range are taught in the prior art. The skilled artisan would have been motivated to have sizes 50-900 nm for stability and for biocompatibility.
As to claim 4, Gassensmith teaches a radionuclide-chelator complex where the radionuclide is Zn and the chelator is an imidazole-based chelator (pg 1, para [0006], lines 14-16).
As to claim 7, Gassensmith teaches a metal-organic framework (pg 7, para [0063], line 3; claim 1) containing radionuclide atoms (pg 3, para [0048]; pg 9, para [0086], lines 1-4 and 10) coordinated with organic molecules in an extended framework (pg 1, para [0006], lines 15-16).
As to claim 8, Gassensmith teaches the carrier is a polyester (pg 20, para [0160], line 9-11; pg 20, para [0162], lines 1-6; claims 17-18, 21, and 22-23).
As to claim 9, Gassensmith teaches PLA (claim 17), PCL (claim 18), and copolymers PLGA (claim 21 and 23-24).
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gassensmith as applied to claims 1-4 and 7-9 above, and further in view of Uflyand, I. E.; et al., Synthesis and Study of Sorption, Antioxidant and Antibacterial Properties of MOF based on Cobalt Terephthalate, and 1,10-Phenanthroline. J. Inorg. and Organometal. Polym. and Mat. 2021, 31, 4710-4721. The teachings of Gassensmith as applied in the previous rejection are incorporated in this rejection.
As to claim 5, Gassensmith teaches a radionuclide-chelator complex.
Gassensmith does not teach a phenanthroline, dipicolinate, or nitrogen-containing macrocycle compound.
Uflyand, I. E.; et al. (hereafter referred to as Uflyand) is drawn to the synthesis and study of phenanthroline-based MOFs and their resultant antioxidant and antibacterial properties (title; abstract). Uflyand teaches the design, synthesis and characterization of phenantrhroline-based MOFs (pg 4711, col 1, para 4; pg 4711, col 2, para 2; pg 4711, col 2, para 3-4; pg 4711, col 1, para 1-2). Uflyand teaches a design motivation to include phenanthroline into MOFs because of improved microbial activity (pg 4711, col 1, para 1, lines 15-17).
Regarding phenanthroline, dipicolinate, or nitrogen-containing macrocycle compounds, Uflyand teaches phenanthroline (title; abstract, lines 1-2; pg 4710, col 2, para 3, lines 4-11; pg 4711, col 1, para 3, lines 4).
As to claim 6, Uflyand teaches phenanthroline (title; abstract, lines 1-2; pg 4710, col 2, para 3, lines 4-11; pg 4711, col 1, para 3, lines 4).
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date to modify the composition of Gassensmith to include the phenanthroline chelators as taught by Uflyand because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of a radionuclide with phenanthroline chelators. A person of ordinary skill in the art would have had a reasonable expectation of success in
combining the teachings to use the phenanthroline chelator because phenanthroline chelator with radionuclide is known to perform similarly to the instant claim. The skilled artisan would have been motivated to combine the teachings of Uflyand with Gassensmith because an increased number of chelator selection enables more adaptability over the physio-chemical properties of the radionuclide-chelator complex.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gassensmith and Uflyand as applied to claims 1-9 above, and further in view of Karami, A.; et al., Hybrid liposome/metal-organic framework as a promising dual-responsive nanocarriers for anticancer drug delivery. Colloids and Surfaces B: Biointerfaces, 2017, 217, 112599-112606. The teachings of Gassensmith and Uflyand as applied in the previous rejection are incorporated in this rejection.
As to claim 10, Gassensmith teaches the carrier may be a liposome (pg 7, para [0066], line 11-13).
Karami, A.; et al. (hereafter referred to as Karami) is drawn to encapsulated MOFs in liposomes (title; abstract). Karami teaches a design motivation to reduce drug leakage and enhance stability (pg 112600, col 1, lines 13). Karami teaches their synthesis (pg 112600, col 2, para 6, lines 1-6; pg 112602; Fig 1) characterization (pg 112601, col 1, para 1, lines 1-21; pg 112603; Fig 4).
Alternatively, Karami teaches the carrier may be a liposome (pg 112600, col 2, para 6, lines 1-6; pg 112602; Fig 1).
It would have been prima facie obvious to a person of ordinary skill in the art before the
effective filing date to modify the liposome to encapsulate the MOF of Gassensmith to include the liposomes encapsulating MOFs as taught by Karami because these claim elements were known in the art and one of ordinary skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome
of liposome encapsulated MOFs.
A person of ordinary skill in the art would have had a reasonable expectation of success in using liposomes to encapsulate MOFs because both the teachings of Gassensmith and Karami teach the benefits. The skilled artisan would have been motivated to use liposomes to encapsulate MOFs because of biocompatibility, flexibility, and modularity of liposomes.
Claim(s) 11-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gassensmith, Uflyand, and Karami as applied to claims 1-10 above, and further in view of Oien-Odegaard, S.; et al., NO 20210895 A1. The teachings of Gassensmith, Uflyand, and Karami as applied in the previous rejection are incorporated in this rejection.
As to claim 11, Gassensmith teaches the composition of claim 1 (abstract; pg 1, para [0006], lines 1-10; pg 9, para [0086], lines 9-10; pg 20, para [0160], line 9-11; claim 1, line 3).
Gassensmith does not explicitly teach that the radionuclide is an alpha emitter.
Oien-Odegaard, S.; et al. (hereafter referred to as Oien-Odegaard) is drawn to MOFs for radiotherapy (title; abstract). Oien-Odegaard teaches a MOF comprising a three-dimensional network of inorganic and organic monomer with functional groups and a targeting moiety and radionuclides (pg 3, linrd 22-25; pg 7, lines 10-23; claim 1, claims 3-4).
Oien-Odegaard teaches alpha-emitting radionuclides (pg 2, lines 1-3; pg 23, lines 4-11).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the radionuclide of Gassensmith to include the alpha-emitters as taught by Oien-Odegaard because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of alpha-emitting radionuclides in the composition. A person of ordinary skill in the art would have had a reasonable expectation of success in using alpha-emitting radionuclides because Oien-Odegaard demonstrates that they are useful for use in radiotherapy and MOFs. The skilled artisan would have been motivated to combine the alpha-emitting radionuclides of Oien-Odegaard with the system of Gassensmith because alpha-emitters allow for additional common radionuclides used in other radiotherapies approved for use in humans.
As to claim 12, Oien-Odegaard teaches alpha emitters actinium-225, thorium-227, radium-223, radium-224, and lead-212.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to substitute the radionuclides of Gassensmith with the alpha-emitting radionuclides of Oien-Odegaard because they 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. A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the radionuclides of Gassensmith with the radionuclides of Oien-Odegaard because Oien-Odegaard shows that radionuclides, regardless of the emitter type, can be used with MOFs. The skilled artisan would have been motivated to make the substitution because these alpha-emitters are common and have demonstrated effectiveness for use in administration to subjects.
As to claim 13, Oien-Odegaard teaches beta emitters (pg 2, lines 1-3; pg 23, lines 4-11).
As to claim 15, Oien-Odegaard teaches a targeting moiety capable of selecting tissue (pg 1, lines 23-29; pg 19, lines 16-32).
Claim(s) 14 and 16-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gassensmith, Uflyand, Karami, and Oien-Odegaard as applied to claims 1-13 above, and further in view of Line, B. R.; et al., US 2004/0258614 A1. The teachings of Gassensmith, Uflyand, Karami, and Oien-Odegaard as applied in the previous rejection are incorporated in this rejection.
As to claim 14, Oien-Odegaard teaches yttrium beta emitters (pg 2, lines 1-3; pg 23, lines 4-11).
Oien-Odegaard does not teach specific beta emitters.
Line, B. R.; et al. (hereafter referred to as Line) is drawn to microparticles used for imaging and radiotherapy (title; abstract). Line teaches a core and a carrier (abstract; Fig 1) and a chelator (pg 13, para [0165]-[0166]) to bind to radionuclides (pg 7, para [0075], lines 5-6; pg 8, para [0092], lines 1-3; pg 11, para [0136], lines 1-4; pg 13, para [0163], lines 1-6; pg 13, para [0165]; Fig 4) and a variety of radionuclides suitable for microparticles (claims 4-8).
Line teaches a beta emitter selected from a group of samarium-153, yttrium-90, and iodine-131 (claim 7 and 8).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to substitute the beta-emitter of Oien-Odegaard with the beta-emitting radionuclides of Line because they 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. A person of ordinary skill in the art would have had a reasonable expectation of success in substituting the yttrium beta-emitter of Oien-Odegaard with the additional beta-emitters of Line because the substitution is made among similar radionuclides. The skilled artisan would have been motivated to make the substitution because of the increased versatility through a greater number of options for the beta-emitters.
As to claim 16, Line teaches moieties that may be selected in order to avoid immunogenic responses upon administration (pg 9, para [0120]).
As to claim 17, Gassensmith teaches a biocompatible composition (pg 20, para [0160], line 9-11) with a metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3) and a carrier encapsulating the metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3). Gassensmith teaches the metal may be a radioisotope (pg 9, para [0086], lines 9-10).
Gassensmith does not explicitly teach treating a cancer.
Line teaches a method for treating cancer in a subject comprising administering an effective dose (claims 43-45).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the composition of Gassensmith to include the method of treating cancer as taught by Line because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of using the composition to treat cancer.
A person of ordinary skill in the art would have had a reasonable expectation of success in
Using the composition to treat cancer because both Gassensmith and Line are drawn to similar compositions and because Gassensmith already teaches a composition containing radionuclides which could be used to treat cancer. The skilled artisan would have been motivated to use the composition of Gassensmith to treat a cancer because treating cancer is a common application for radionuclide-based compositions and there is significant humanitarian motivation to help treat cancers.
As to claim 18, Gassensmith teaches a radionuclide-chelator complex where the radionuclide is Zn and the chelator is an imidazole-based chelator (pg 1, para [0006], lines 14-16).
As to claim 19, Line teaches cancers such as ovarian cancer and breast cancer (pg 6, para [0065]; claim 48).
As to claim 20, Gassensmith teaches a biocompatible composition (pg 20, para [0160], line 9-11) with a metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3) and a carrier encapsulating the metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3). Gassensmith teaches the metal may be a radioisotope (pg 9, para [0086], lines 9-10).
Gassensmith does not explicitly teach treating an infection.
Oien-Odegaard teaches treating an infection in a subject (pg 35, lines 31-36 and pg 36, lines 1-4) and administering in an effective dose (pg 36, lines 14-23).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the composition of Gassensmith to include treating an infection as taught by Oien-Odegaard because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of using the composition of Gassensmith to treat infections. A person of ordinary skill in the art would have had a reasonable expectation of success in using the composition of Gassensmith to treat infections because MOFs are known to be useful for antibacterial or antifungal agents. The skilled artisan would have been motivated to use the composition of Oien-Odegaard to treat infections because there is a great need in hospitals and in wound-care to reduce frequency and treat infections.
As to claim 21, Oien-Odegaard teaches a method for the MOF to be used as an antibacterial or antifungal for a bacterial or fungal infection (pg 30, lines 1-5; pg 30, 10-16).
As to claim 22, Gassensmith teaches a radionuclide-chelator complex where the radionuclide is Zn and the chelator is an imidazole-based chelator (pg 1, para [0006], lines 14-16).
As to claim 23, Gassensmith teaches a biocompatible composition (pg 20, para [0160], line 9-11) with a metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3) and a carrier encapsulating the metal-containing core (abstract, lines 2-10; pg 1, para [0006], lines 1-10; claim 1, line 3). Gassensmith teaches the metal may be a radioisotope (pg 9, para [0086], lines 9-10). Gassensmith teaches a method of imaging biological tissue (pg 15, para [0122], lines 13-18).
Gassensmith does not teach imaging biological tissue in the subject by a nuclear medicine imaging technique.
Line teaches imaging biological tissue in the subject by a nuclear medicine imaging technique (pg 3, para [0021], lines 1-9).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to modify the methods of Gassensmith to include a method of nuclear imaging of biological tissue as taught by Line because these claim elements were known in the art and one of skill in the art could have combined these elements by known methods with no change in their respective functions, and the combination would have yielded the predictable outcome of using the composition of Gassensmith to achieve an imaging method.
A person of ordinary skill in the art would have had a reasonable expectation of success in developing a method of nuclear imaging of biological tissue because radionuclide-containing compositions are essential to the method and the composition of Gassensmith contains the radionuclide. The skilled artisan would have been motivated to use the composition for nuclear imaging of biological tissue because imaging is incredibly useful in diagnostics of diseases.
As to claim 24, Gassensmith teaches a radionuclide-chelator complex where the radionuclide is Zn and the chelator is an imidazole-based chelator (pg 1, para [0006], lines 14-16).
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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/EVAN M LEWOCZKO/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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