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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the Republic of Korea on 2/06/2023. It is noted, however, that applicant has not filed a certified copy of the KR10-2023-0015724 application as required by 37 CFR 1.55.
Claim Objections
Claims 11 and 17 are objected to because of the following informalities: the claims employ “mesh” sizes to define ranges of particle sizes, and refer to sizes of particles relative to these ranges using terms “more” and “less.” From the context, it is clear that the terms “more” and “less” refer to the size of the particle, not the mesh number, as e.g. in claim 11 the term “more” refers to particles larger than 200 mesh and “less” refers to particles smaller than 2 mesh. One of ordinary skill in the art would well recognize that a “mesh” number has an inverse relationship with particle size, so the use in the claims is properly definite. However, to improve clarity examiner suggests using terms such as “larger” and “smaller” instead of “more” or “less” to make it clearer that these comparisons are referencing the particle size, and not the magnitude of the mesh number as an abstract value.
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.
Claims 1-7, 9-13, and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Oinuma et al (JP 3216256 B2) in view of Wang et al (Development of Coconut Shell Activated Carbon-Tethered Urease…, ACS Sustainable Chem. Eng. 2014).
Examiner notes that specific operating conditions in product-by-process limitations do not limit the product (and therefore the process of using said product) unless it can be shown that they result in a different structure compared to the prior art product.
With respect to claim 1, Oinuma teaches processes for production of ultrapure water [0001] which employes a treatment step with a urease immobilized on a carrier (i.e. catalyst particles) [0027] such as an activated carbon [0028], and subsequently employs a reverse osmosis membrane separation [0021]. Oinuma does not teach particles which are produced by the claimed production steps; although the catalyst production limitations may be interpreted as product-by-process limitations, they nevertheless are interpreted as resulting in structural differences i.e. the presence of a linker at minimum.
However, Wang teaches methods of improving urease packed bed reactors by immobilizing the urease on an activated carbon using a tether [Abs]. The process includes preparing the surface of the activated carbon by oxidation, and then employing linkers such as aminosilanes and aldehydes to facilitate tethering of the urease, and attaching urease at a pH of about 7.2 (about 6 to about 8) [pg. 434, Functionalization of Coconut Shell AC; Fig. 1]. Wang teaches that this provides improved properties such as pH and temperature stability.
It would have been obvious to one of ordinary skill in the art to modify the urease materials employed by Oinuma, which are not particularly limited, to employ tethering using linkers as suggested by Wang because as in Wang this provides improved properties for packed bed urea decomposition applications.
With respect to claim 2, Oinuma teaches that the catalyst particles may be washed at regular intervals if necessary e.g. due to clogging which may occur in some configurations [0033].
With respect to claims 3 and 16, Oinuma teaches that the immobilized urease bed can achieve a decomposition rate of 90% with an appropriate contact time e.g. 10 minutes, which represents a practical level of utility [0031]. Oinuma does not specify that the output from this step has 20 µg/L or less (i.e. 20 ppb or less) of urea; however, Oinuma does teach that the overall output of the system has TOC of 0.5-0.8 ppb such that a high degree of urea removal is at minimum suggested [0041].
See MPEP 2144.05 II.A; "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Optimization of the operating conditions e.g. residence time to achieve a desirably low urea level in the effluent would have been obvious to one of ordinary skill in the art in view of the guidance of Oinuma.
With respect to claim 4, Oinuma does not particularly specify the pH of the feed or fluid after treatment with urease. However, Wang examines the pH sensitivity of immobilized urease [pg. 436, Fig. 6] and shows the highest relative activity in the range of pH 6.5-8.0. As such, optimization of the pH conditions around the urea removal step, to ensure optimal urease activity, would have been obvious to one of ordinary skill in the art.
With respect to claims 5 and 6, Wang teaches employing an aminosilane such as APTMS [pg. 434] and operating under reflux in toluene to couple.
With respect to claims 7 and 15, Wang further employs glutaraldehyde (a dialdehyde) for tethering.
With respect to claims 9 and 10, as above both Oinuma and Wang employ activated carbon; further, Wang teaches preparing the carbon by oxidizing with nitric acid to prepare for tethering [pg. 434] at about 80 ⁰C. Regarding the concentration, as discussed above for product-by-process limitations, the specific parameters employed for production of the catalyst do not limit the method of using the catalyst product unless it can be shown that they result in a different structure.
With respect to claim 11, see the rejection of claim 1 above. Regarding additional limitations, Oinuma teaches that the catalyst particles may be washed at regular intervals if necessary e.g. due to clogging which may occur in some configurations [0033]; further, Wang teaches employing 200 mesh or more and 3 mesh or less (where “more” and “less” are interpreted as referring to the size of the material and not the mesh number, as mesh number has an inverse relationship to size) e.g. a range of 20-40 mesh [pg. 434].
With respect to claim 12, Wang teaches refluxing in toluene to coat the linker on the surface. Regarding time and temperature, as discussed above for product-by-process limitations, the specific parameters employed for production of the catalyst do not limit the method of using the catalyst product unless it can be shown that they result in a different structure.
With respect to claim 13, Wang teaches that the urease immobilization step is carried out at a temperature of about 4 ⁰C for 48 hours in a solution with pH about 7.2, such that the claimed ranges are at minimum obvious as the taught values overlap or lie within them.
With respect to claim 17, see the rejections of claims 1 and 11 above. Regarding additional limitations, Wang teaches that the urease immobilization step is carried out at a temperature of about 4 ⁰C for 48 hours, such that the claimed ranges are at minimum obvious as the taught values overlap or lie within them. Further, Wang teaches oxidizing the carbon with nitric acid to prepare for tethering.
With respect to claim 18, Wang teaches preparing the carbon by oxidizing with nitric acid to prepare for tethering [pg. 434] at about 80 ⁰C. Regarding the concentration, as discussed above for product-by-process limitations, the specific parameters employed for production of the catalyst do not limit the method of using the catalyst product unless it can be shown that they result in a different structure.
With respect to claims 19 and 20, Wang teaches adding silane coupling agent and refluxing in toluene to coat the linker on the surface. Regarding time and temperature, as discussed above for product-by-process limitations, the specific parameters employed for production of the catalyst do not limit the method of using the catalyst product unless it can be shown that they result in a different structure.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Oinuma et al in view of Wang et al, optionally further in view of Mondal et al (Exuberant Immobilization of Urease on an Inorganic SiO2 Support…, Bioconjugate Chem., 2019).
Oinuma and Wang teach absorbent particles with urease thereon as above, including carbon, and other species suggested by Oinuma at least [0028]; Oinuma teaches “sand” which at minimum would render silica obvious to one of ordinary skill in the art.
Additionally, Mondal teaches that silica e.g. silica gel particles can be used to immobilize urease using silane coupling regents [Abs] with enhanced enzymatic activity. As such, one of ordinary skill in the art would recognize that silica e.g. the sand suggested by Oinuma, or equivalents, would be suitable for immobilization of urease even when employing linkers via silane coupling, as in Mondal.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Oinuma et al in view of Wang et al, further in view of Vernon et al (Entrapment of enzymes using organo-functionalized polysiloxane copolymers, Biochimica et Biophysica Acta, 1995).
Oinuma and Wang teach as above, including Wang’s teaching of APTMS (3-aminopropyl trimethoxysilane) but does not teach the specific claimed species. However, Vernon examines immobilization of urease to improve stability for e.g. urea degradation [Abs] and employs as one of the species 3-aminopropyl triethoxysilane. The simple substitution of one known aminosilane linker shown to be useful for binding of urease for another, i.e. a methoxysilane vs. an ethoxysilane species, represents an obvious substitution for one of ordinary skill in the art according to their known utility in the field i.e. as in Vernon. As such, employing the ethoxysilane species in the modified process of Oinuma would have been obvious to one of ordinary skill in the art.
Conclusion
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/BRADLEY R SPIES/Primary Examiner, Art Unit 1776