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 Claims
Claims 2, 6, 7, 9, 12, and 13 are cancelled. Claims 1, 3-5, 8, 10-11, and 14-18 are pending and under examination.
Priority
This application is a 371 of PCT/US2023/014471, filed on 3/3/2023. The application is claiming priority to U.S provisional Application No. 63/316,576, filed on 3/4/2022.
Rejections Withdrawn
The rejection under USC 112(b) for shape specific is withdrawn per applicant’s amendments.
The rejection under USC 112(b) for use of ex vivo is withdrawn per applicant’s amendments to the claims.
The rejection under USC 112(b) over claims 7 and 9 is withdrawn per applicant’s claim cancellations.
The rejection under USC 112(d) over claims 8 and 10 is withdrawn per applicant’s change in dependency with amendments to claim 1, on which these claims now depend.
The rejection under USC 102 over Rakshe is withdrawn per applicant’s amendments to the claims, particularly the size limitation of the nanoparticles.
As these rejections are withdrawn, applicant’s arguments toward these rejections are now moot.
New Claim Objection - As Necessitated by Applicant’s Amendments
Claim 10 is objected to for “cube has an average diameter” while a cube does not technically have a diameter, however, it can be changed to length (e.g. average length) to make sense with “cube”. Note in a cube, the length, height and width are equal sizes. Appropriate correction is required.
New Rejections – As Necessitated by Applicant Amendments
Claim Rejections - 35 USC § 112 (b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 is indefinite for depending on a cancelled claim. It is unclear what claim that claim 15 should be dependent on and it would lack antecedent basis for “the pharmaceutical composition” as there is no claim 13. For the purpose of compact prosecution, the examiner will consider claim 15 as being dependent on claim 11.
Claim 14 recites the limitation "the shape-specific cerium oxide nanoparticles" in the claim with dependence to claim 11 that no longer carries such an object. The applicant should refer to “the plurality of cerium oxide nanoparticles” or can refer to “the composition” instead. There is insufficient antecedent basis for this limitation in the claim. Furthermore, this claim should refer to “the patient” introduced in claim 11.
Claim 16 is rejected for being dependent on an indefinite claim.
Claim 17 recites the limitation "the cube-shaped cerium oxide nanoparticles" in lines 15, 17, 19 and 22 while the initial recitation has been amended to “a plurality of cube-shaped cerium oxide nanoparticles”. There is insufficient antecedent basis for this limitation in the claim. Applicant may amend these recitations to refer back to “the plurality of cube-shaped cerium oxide nanoparticles”.
Claim 18 is rejected as being dependent on an indefinite claim.
Claim 17 is also indefinite for the recitations of “wherein the plurality of sphere-shaped and the cube-shaped cerium oxide nanoparticles in the shape of cube” and “wherein the plurality of sphere-shaped and the cube-shaped cerium oxide nanoparticles in the shape of a sphere” as it becomes unclear by the first mentioned wherein clause if all the nanoparticles are now cubes although it appears to introduce sphere-shaped and cube-shaped and unclear by the second mentioned wherein clause if all the nanoparticles are spheres. It is noted that applicant presents (i) or (ii), so applicant may just have a wherein clause providing what the plurality of cube-shaped nanoparticles provide and the other wherein clause providing what the plurality of sphere-shaped nanoparticles provide.
Claim 18 is rejected as being dependent on an indefinite claim.
Maintained Rejections – Modified As Necessitated by Amendments
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, and 11, and 14-16 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Hosseini et al (Materials (Basel), 2020, volume 13, pages 1-46).
In regard to claims 1 and 11, the plurality of cerium oxide nanoparticles are in optional form with sphere-shaped, cube shaped or the combination. Although the claim provides “wherein” clauses to functionalities of those shape nanoparticles and the cerium oxide nanoparticles, it does not provide that both cube and sphere-shaped have to both be present in the composition or method. Thus, if the prior art teaches “cubed-shaped” and/or “sphere-shaped” cerium oxide nanoparticles within the size ranges in a composition with pharmaceutical carrier, it will read on that limitation.
In regard to claims 1 and 11, if the prior art teaches the cerium oxide nanoparticles of such shapes (cube and sphere), they will be capable of these effects in “wherein” clauses.
In regard to claim 11, it contains the options of “respiratory syncytial virus disease OR other infection”. If the prior art teaches a different type of infection or infectious disease, it will read on “other infection that causes a pathologic immune response”.
Claim 11 also does not direct “a subject” in the body of the claim to be “a subject in need thereof” to refer back to the treating in the preamble.
Hosseini teaches submicron biomaterials and provides for cerium oxide nanoparticles for tissue engineering and regenerative medicine (abstract). Hosseini teaches “The SOD-, CAT-, and oxidase mimetic activities of CeONPs are found to be due to the co-existence of 3+ and 4+ oxidation states (chemical forms of Ce (III) and Ce (IV), respectively), which ultimately result in a redox couple in control of their antioxidant effect. This ability of Ce to switch between the 3+ and 4+ valence states is similar to the mechanism of redox enzymes, which make use of metals as co-factors in order to catalyze reversible redox reactions” (figure 4). Hosseini teaches the effect of size and shape including making different shapes of cerium oxide nanoparticles that are spheres, cubes, rods or wires, which teaching of nanocubes and nanospheres (section 5.1, last paragraph). In section 4.2 (second paragraph of 4.2), there is a teaching of sizes of 3–5, 10–15, 15–20, >25, and 50–60 nm. Section 4.2 also provides nanorods. Hosseini teaches “Their results showed that the synthesized CeONPs had an average size of 19.5 nm and a cubic morphology” (section 4.2. 4th to 5th paragraph). Hosseini teaches a stable suspension of 24 to 290 nm (section 5.2, also table 3). Hosseini teaches implanting or injecting to initiate healing or regeneration processes (section 4.4). Hosseini provides for cerium nanoparticles inhibiting wound infection (last paragraph of 4.3 regarding wound healing and skin regeneration). Hosseini teaches biomaterials with polymers and forms of cryogels (gel) (section 4.3). Hosseini provides for antibacterial activities of Cerium oxide nanoparticles (section 3). Hosseini teaches using cerium oxide nanoparticles for stem cell differentiation in scaffolds (would be ex vivo, out of the body) (section 4.1). This providing of the nanoceria to the stem cells allows for priming of the cells. Hosseini teaches “However, a stable dispersion of NPs can also be obtained at low zeta potentials, especially when high molecular weight polymers, surfactants, or stabilizers are used (known as steric stabilization). Hence, a minimum zeta potential of ±20 mV is desired for electrostatic and steric stabilization” (section 5.2). Thus, it was known by teachings of Hosseini that cerium oxide nanoparticles can be formed in shapes including cubes, rods and spheres, placed into carrier forms such as nanoparticles or suspensions, and be applied to subjects whether injected directly or applied to tissue scaffolds ex vivo before administration/applying/implanting. Hosseini also recognizes the application of cerium oxide nanoparticles helps prevent infections in the context of wounds and have antimicrobial/antibacterial activity. Thus, they are anticipated to treat “other infections” that would cause pathologic immune responses. It is noted that claim 14 was amended to “in vivo” and as Hosseini provides for administration of the cerium oxide nanoparticles to a wound, it will have the effect to prime cells at the wound site in vivo.
Claim 17 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Lin et al (Crystal Growth and Design, 2012, volume 12, pages 3296-3303).
In regard to claim 17, if the prior art teaches the cerium oxide nanoparticles of such shapes (cube and sphere), they will be capable of these effects in “wherein” clauses. Note this claim is to a method making the nanoparticles.
Note that claim only requires either (i) or (ii) to happen to do the method (either making sphere-shaped or making cube-shaped cerium oxide nanoparticles).
Lin teaches hydrothermal synthesis of CeO2 nanocrystals (abstract). Lin teaches “The growth mechanism of CeO2 nanocrystals prepared by the hydrothermal method has been studied in this article. The synthesis of CeO2 nanocrystals follows two stages, the initial nucleation of CeO2 nuclei and the subsequent ripening of nuclei in the hydrothermal process. The nucleation involves the precipitation of Ce3+ cations by OH− ions to form Ce(OH)3 nanoparticles and the transition from Ce(OH)3 to 2−3 nm CeO2 nuclei through an oxidation and rapid dehydration process.” (abstract and section 3.4). Figure 2 provides for cube shaped cerium oxide nanocrystals. Section 3.2 provides for Ce(OH) precursors for CeO2. Lin teaches “For hydrothermal synthesis in higher concentrated basic medium, CeO2 nanocubes or nanowires are synthesized from the Ce(OH)3 precursor instead (Conclusions, page 3302-3303). Lin teaches “Typically, 0.9 g of PVP (polyvinylpyrrolidone, molecular weight 30 000, final concentration 30 g/L) and 1 mmol of cerium nitrate hexahydrate (Ce(NO3)3·6H2O) were dissolved in 30 mL of deionized (DI) water. Different amounts of sodium hydroxide (NaOH), ranging from 1 to 10 mmol, were added into the mixture to precipitate the salt in order to investigate its role played in the synthesis process” (section 2, page 3297). Lin teaches formation of rod-like nanocrystals, but nanocrystals can be converted into crystals with well-defined edges (second column of page 3301 to first column of page 3302). Thus, Lin provides for the reaction of the cerium nitrate and sodium hydroxide to form an intermediate Ce(OH)3 nanoparticles that have rod-like morphology, oxidation to form CeO2, and convert them to cubes (structures having defined edges) (also see figure 8). The introduction of Lin provides that there is a reversible transition between Ce3+ and Ce4+ oxidation states (page 1).
Response to Applicant’s Arguments Concerning the Rejections under USC 102 over Hosseini and over Lin
Applicant argues that Hosseini does not provide cubes or spheres having dimensions of 2 to 100 nm. Hosseini provides for cube and sphere shaped cerium oxide nanoparticles in its teachings as well as sizes of nanoparticles being from 3–5, 10–15, 15–20, >25, and 50–60 nm. Note Hosseini teaches “synthesized CeONPs had an average size of 19.5 nm and a cubic morphology”. Hosseini anticipates using such nanoparticles in formulations for administration to wounds and for regenerative medicine purposes (biomaterials, polymers, cryogels, etc), and thus, pharmaceutical carriers. Hosseini’s teachings allow for a composition of claim 1 and Hosseini’s further teachings of wound infections and administration to wounds provides for administering to treat infections in a subject. Hosseini recognizes the antibacterial properties of the nanoparticles, which also provides they would treat bacterial infections. Such infective pathogens are known to activate the immune response.
Applicant argues that the claims do not provide for the activities of the cubes or spheres or nanoparticles in general that have been added to applicant’s claims after amendment to add “wherein” clauses. The prior art teaches cerium oxide nanoparticles of the claimed shapes and using such nanoparticle sizes. As these cerium oxide nanoparticles are provided by the prior art with such shapes and sizes, they will be capable of such activities when administered (see MPEP 2112). Note that these activities are activities of the nanoparticles themselves. Note that Hosseini provided for both antimicrobial/antibacterial activity and the switch in cerium oxidation state, and thus, the nanoparticles are presumed to share similar properties.
Applicant argues that there is not a nanoparticle in Lin with a size of 2 to 100 nm that is a sphere. Applicant also argues Lin doesn’t recognize the activities as added to the process of making nanoparticles claim. Note in Lin, “Figure 2 provides for cube shaped cerium oxide nanocrystals” and Lin recognizes “2−3 nm CeO2 nuclei”. Thus, Lin anticipates particles can fall into this size range and also be formed with a cube shape. The main purpose of Lin was in the teachings of claim 17 as it provides for the process of making cube-shaped cerium oxide nanoparticles as in the option of (ii). As Lin anticipates a process of making such nanoparticles in cube shape and provides for sizes of cerium oxide nanoparticles produced and used in the process, nanoparticles are anticipated to have such sizes within the range. Therefore, the teachings of Lin continue to anticipate applicant’s claim 17. As Lin provides for such cube cerium oxide nanoparticles of one of the process options, they will carry those activities as those are activities of the nanoparticles (MPEP 2112). Note that the claim is a process of making nanoparticles and not a process of treating respiratory syncytial virus.
Therefore, these rejections are maintained.
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.
Claims 8 and 10 in addition to claims 1, 3-5, and 11, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Hosseini et al (Materials (Basel), 2020, volume 13, pages 1-46).
Hosseini teaches the claims as discussed above.
Hosseini provides for nanoparticles and overlapping size ranges of the claims as provided above. Hosseini teaches adjusting shapes and sizes can control cytotoxicity of the particles (section 5.1).
One of ordinary skill in the art before the time of filing would have produced cerium oxide nanoparticles and adjusted sizes of cerium oxide nanoparticles in order to obtain cerium oxide nanoparticles with lower cytotoxicity. Thus, there was a reasonable expectation of success in producing shaped cerium oxide nanoparticles and routinely optimizing such nanoparticle sizes to control toxicity by the teachings of Hosseini. Additionally, note that as Hosseini provides for both cubes and spheres for nanoparticles, it is capable of combinations of the two for that particular option of “combination”.
Claims 1, 3, 5, 8, 10 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al (J Nanobiotechnology, 2019, volume 17, pages 1-27).
In regard to claims 1 and 11, the plurality of cerium oxide nanoparticles are in optional form with sphere-shaped, cube shaped or the combination. Although the claim provides “wherein” clauses to functionalities of those shape nanoparticles and the cerium oxide nanoparticles, it does not provide that both cube and sphere-shaped have to both be present in the composition or method. Thus, if the prior art teaches “cubed-shaped” and/or “sphere-shaped” cerium oxide nanoparticles within the size ranges in a composition with pharmaceutical carrier, it will read on that limitation.
In regard to claims 1 and 11, if the prior art teaches the cerium oxide nanoparticles of such shapes (cube and sphere), they will be capable of these effects in “wherein” clauses.
In regard to claim 17, if the prior art teaches the cerium oxide nanoparticles of such shapes (cube and sphere), they will be capable of these effects in “wherein” clauses. Note this claim is to a method making the nanoparticles.
Thakur teaches nanoceria and synthetic processes for them (abstract). Thakur teaches different methods of making nanoceria including the hydrothermal method and sonochemical method (involves ultrasound/ultrasonication) (figure 1). Thakur teaches the hydrothermal method and provides for cerium nitrate with sodium hydroxide and then provides a shape dependent oxygen storage capacity of synthesized nanoparticles with nanorods and nanocubes (page 5, first column). Note sodium hydroxide is source of hydroxyl ions. Thakur teaches an oxidation method that is direct and straightforward which involves oxidizing (page 6). Thakur teaches the sonochemical method by use of ultrasound (aka ultrasonication) (pages 6-7). Thakur teaches other methods that provide synthesized nanoceria that is spherical (page 9). Thakur teaches different size ranges including 10-20 nm and others as well as spherical and cubical/cubic particles (tables 11-12, page 2). Thakur teaches biomedical applications of nanoceria including antibacterial activity (page 10). Thakur teaches administering nanoceria to subjects (table 16). Thakur teaches intraperitoneal injection and oral administration (page 22). Thakur teaches nanoparticles (second column of page 10). Figure 4 provides for surface coating of cerium oxide nanoparticles (page 15). Thakur recognizes the control of size and shape of the nanoceria being important for properties (abstract). Thakur recognizes that the toxicity of CNPs is partially dependent on particle size and preparation method (page 22). Thakur teaches intranasal administration on page 22. Thakur’s table 1, item 10 provides for polyethylene glycol in combination with cerium nitrate and sodium hydroxide in formation of nanoparticles. Thus, Thakur allows for polyethylene glycol compounds in addition where it can adsorb to the nanoparticles being formed. mPEG is a related form to polyethylene glycol.
One of ordinary skill in the art before the time of filing would have been able to produce cerium oxide nanoparticles/nanoceria of different shapes including spherical and cubical by means of hydrothermal and sonochemical (involves ultrasonication) methods, put them into deliverable forms for oral and injection administrations and provide them in acceptable sizes for delivery to subjects by teachings of Thakur, which provides for these methods and nanoparticles made by such processes. Size is also seen as important for controlling properties and toxicity of the nanoparticles in Thakur and would be routinely optimized for those reasons. There would be a reasonable expectation of success in using known methods to produce shape specific (cube or sphere) cerium oxide nanoparticles useful for biomedical applications that involve administration to subjects. One of ordinary skill in the art would adjust the known processes of the prior art to reduce the toxicity of the formed nanoparticles while increasing beneficial properties in effectiveness.
Claims 11 and 14-15 in addition to Claims 1-3, 5-10 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al (J Nanobiotechnology, 2019, volume 17, pages 1-27) and Dar et al (Crystals, January 2022, volume 12, pages 1-10).
In regard to claim 11, it contains the options of “respiratory syncytial virus disease OR other infection”. If the prior art teaches a different type of infection or infectious disease, it will read on “other infection that causes a pathologic immune response”.
Claim 11 also does not direct “a subject” in the body of the claim to be “a subject in need thereof” to refer back to the treating in the preamble. Thakur teaches the claims as discussed above. It was noted above the Thakur provides for administering to subjects, IP injection and oral administration, as well as noting the antibacterial activity.
Thakur does not teach administering the cerium oxide nanoparticles to the patient to treat an infection.
Dar teaches using cerium oxide nanoparticles for their antibacterial activities against various bacteria (abstract and section 2.4). Dar teaches potential for in vivo therapeutic applications due to the antibacterial activity (abstract and conclusion). Bacteria are an infectious microbe.
One of ordinary skill in the art before the time of filing would have administered the ceria nanoparticles in forms taught by Thakur to patients with bacterial infections in vivo to treat such bacterial infections by teachings of Dar that notes effectiveness of the cerium oxide nanoparticles against infectious bacteria. Thus, there was a reasonable expectation of success in administering the cerium oxide nanoparticles to subjects by means provided in the prior art to treat bacterial infections in a subject/patient and providing successful treatment.
Response to Applicant’s Arguments Regarding the Rejections under USC 103
Applicant uses “comprising” as a transition phrase for the composition and methods, which allows for other agents of the prior art to be included including other forms of additional nanoparticles.
Applicant argues that Hosseini does not have particles of recited shapes in the claimed size range. This rejection under USC 103 was to address size range (claims 8 and 10) and the teachings of size ranges for cerium oxide nanoparticles in Hosseini would be considered by one of ordinary skill in the art to make other cerium oxide nanoparticles of such sizes (see MPEP 2144.05). The examiner has also addressed teachings of Hosseini above regarding USC 102. Thus, Hosseini obviates cerium oxide nanoparticle sizes found within the ranges of its teachings. Applicant also does not argue with providing evidence to show the criticality of such a size range with particular shape compared to other shapes like rods or nanowires or compared to other nanometer sizes. Note the use of “nanoparticle” also implies sizes within the nanometer range. Therefore, the teaching of the sphere and cube shaped cerium oxide nanoparticles in Hosseini along with mentioned size ranges provides a basis to make nanoparticles of such sizes with the reasonable expectation of obtaining other cerium oxide nanoparticles with their antimicrobial activities and ability to change cerium redox state, which are also taught in Hosseini. It was noted above how Hosseini anticipates independent claim 1 of applicant.
Applicant argues that Thakur does not provide for the sizes that have the effects noted by applicant. Thakur teaches particles of shapes of applicant’s claims as well as 10-20 nm for particle size of nanoceria. Its nanoceria are noted as spherical. Thakur also teaches a method of making spherical nanoparticles that obviates applicant’s method of making claim for part (i). Therefore, Thakur obviates applicant’s claims and the properties/activities would be of the claimed particles that are able to be produced by Thakur’s teachings.
As Thakur obviates the claims as noted, the combination of Thakur with Dar continues to motivate the claimed method of treatment of infections where microbial infections such as bacterial will cause an immune reaction.
If applicant were to amend the method of treatment claim to more strictly “treating respiratory syncytial virus disease” by removing “or other infection…” and indication “administering to a patient in need thereof” in the body of the claim, applicant’s claim 11 may be in condition for allowance barring other issues that might be brought on during an amendment (objections, 112s or prior art issues if broadening claims). However, claims 1 to the composition and claim 17 to the process of making cerium oxide nanoparticles would continue to be taught (anticipated and/or obviated) by the cited prior art, which teaches the shapes, sizes/size ranges, compositions, and process steps of applicant’s claims. The use of similar shapes, sizes and processing methods will form cerium oxide nanoparticles having activities of applicant’s claims (MPEP 2112).
Conclusions
No claim is found allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613
