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 .
Claims 1-20 are pending and have been considered on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
The priority date is the filing of the 371 application which is 10/22/2022.
Information Disclosure Statement
There are prior art listed in the instant specification. For example, paragraph [0058] discloses multiple prior art. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claims 1, 5, 7, 12-13 and 19 are objected to because of the following informalities:
Claim 1 discloses “suspension cell culture” in line 1. There should be an article “a” in front of the term.
Claim 5 does not end with a period.
Claim 7 discloses “being culture” in line 2. It should be “being cultured” instead.
Claim 12 discloses “cultured in the adaptive subculture” in line 2. There is the term “medium” missing after the term “subculture”.
Claim 13 discloses “Anti-clumping agent”. It would be more appropriate as “an anti-clumping agent” instead.
Claim 19 discloses the term “mediu” in line 2. It is a typographical error of “medium”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 and its dependent claims disclose a method of generating a cell line for producing virus in a suspension culture, and the method involves 1) selecting the plurality of cell clones for higher transfection efficiency using a reporter gene in an adherent cell culture, and then selecting the clones with high transfection efficiency transfected with a second reporter and a virus packaging plasmid in a suspension culture.
The claim discloses “a cell line” or “a cell”, however, the scope of this term is extremely broad as it is not particularly defined as a specific type of cells. While it is known in the art that various mammalian cells are utilized for virus production, however, the claims of the instant specification do not limit the type of cells, not even to a mammalian cell.
Claim 5 discloses a culture medium utilized for the method and the listed species are directed for HEK cells.
The instant specification does not provide sufficient written description to support the broad scope of the “cell” or “cell line”, and the examples provided for the claimed method is limited to HEK293 cells.
M.P.E.P. §2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus…when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
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 1-20 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.
The term “high transfection efficiency” and “high titers” in claims 1, 10 and 20 are a relative term which renders the claim indefinite. The term “high” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Without defining what would be included or excluded as “high” transfection efficiency, claims are considered indefinite as one cannot determine the boundary.
Claims 5, 8, 13 and 19 contain the trademark/trade names of cell culture media commercially available in the art (i.e. VP-SFM, SFM4HEK293, SFM4Transfx293, OPM293CD05…), claims 13 and 19 disclose “GlutaMax” which is a trademark, and claim 16 discloses PEIpro®, PEI MAX® and VirusGreen®, which are all registered trademarks. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe cell culture media and, accordingly, the identification/description is indefinite. For search purpose, the culture medium is generally considered as any medium or any serum-free medium, and GlutaMax is interpreted as L-alanyl-L-glutamine dipeptide, or agents used for transfection (claim 16) is considered as any agent for transfection.
Claims 7, 10-12 and 14 disclose “each of the group of cell clones” referring to claim 4 which is dependent on claim 1. As claim 4 discloses the step (iii), the term “each of the group of cell clones” appears to point out “each of the group of cells clones with high transfection efficiency”. However, it is not clear if this “group of cell clones” is referring those disclosed in the earlier steps (i)-(ii). Clarification is required. Applicant is advised to add “with high transfection efficiency” at the end of the term “each of the group of cell clones”.
Claims 11-13 disclose the term “adaptive subculture medium”. It is not clear what the scope of this term intends to point out. The term does not particularly define the scope of the functional language of “adaptive”, and it is not clear what medium would be included or excluded as the claimed medium. Clarification is required. For search purpose, the term is interpreted as any medium for subculturing.
Furthermore, claims 11-13 are directed to the use of the adaptive subculture medium after being cultured in the serum free medium. It is not clear if the use of the adaptive subculture medium is a part of step (iii) or referring to the subsequent steps after the step (iii). Clarification 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) 1-2, 4-5, 7, 10-12, 14-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghani et al. (2007, Gene Therapy) in view of Grieger et al. (2016, Molecular Therapy) and Ho et al. (Ho et al. 2020, Gene Therapy)
Ghani et al. teach a method of generating a high-titer packaging cell line for the production of virus in suspension and serum-free media (entire document). Ghani et al. teach that the use of serum may introduce biological contaminants like proteins, toxins, viruses and prions, and serum is an expensive raw material, and it increases the complexity, duration and cost of downstream processing (purification, concentration and vector recovery) (p.1, 2nd col. Introduction). Regarding the suspension culture, Ghani et al. teach that the culture of packaging cells is not easily scalable using adherent systems (T-flasks, roller bottles, hollow fibers, microcarriers, Cell Factories and packed beds), and a packaging cell line that could grow in suspension would allow vector production in bioreactors with practically no size limit, and with higher cell densities compared to adherent cells that are limited to growth surface (p.2, 1st col.).
Ghani et al. utilize a virus packaging vector and a transfer vector, and the transfer plasmid contains a gene encoding GFP, a reporter gene (Fig. 1). Ghani et al. teach screening 293GP-A clones for the transduction of the virus packaging plasmid by detecting the GFP fluorescence using FACS analysis (Fig. 3). The teachings of Ghani et al. are considered to meet the step (iv) of claim 1.
Ghani et al. do not teach the steps of identifying HEK293 cell clones in adherent cell culture having high transfection efficiency (i.e. steps (i)-(iii) of claim 1).
Grieger et al. teach that an adherent HEK293 cell line derived from a clone previously selected for high transfection efficiency and rAAV production was adapted to grow in serum-free suspension conditions (p.288, 1st col.).
It would have been obvious to a person skilled in the art to utilize HEK293 clones that have been previously selected for high transfection efficiency as adherent culture taught by Grieger et al. for the method of Ghani et al. A person of ordinary skilled in the art would have been motivated to do so because the HEK293 cell lines that have determined for their high transfection efficiency would produce high virus titer of the desired virus with a reasonable expectation of success.
Regarding the step (i) directed to generating a plurality of cell clones and each cell clone sharing a common ancestry, Grieger et al. teach a clone previously selected for high transfection efficiency (p.288, 1st col.), and this teaching is considered that one skilled in the art have screened multiple clones and then selected a clone for high transfection efficiency. As the selected HEK293 clone is derived from GMP facility’s qualified master cell bank, it is considered that all the clones selected for high transfection efficiency are from common ancestry.
Regarding the first reporter gene being expressed in each cell clones, Ghani et al. in view of Grieger et al. do not particularly teach the use of a reporter gene or a reporter plasmid. However, it would have been obvious to a person skilled in the art that a reporter gene would be utilized for determining transfection efficiency. For example, Ho et al. teach the use of reporter assays such as GFP expression for transfection efficiency of HEK293 cells (see Fig. 1).
Regarding the steps (i)-(iii) by allocating a cell fraction from each clones, the group of cell clones with high transfection efficiency, and each of the plurality of cell clones growing in suspension, respectively, Ghani et al. in view of Grieger et al. do not particularly teach the limitation. However, it would have been obvious to a person skilled in the art to carry out the step of identifying a group of cells or cell clones by using a sample/portion of the cells or cell groups as the step is for assaying for the desired features, i.e. high transfection efficiency. In fact, Grieger et al. teach samples were analyzed for transfection efficiency/GFP expression using flow cytometry (p.295, 2nd col.).
Regarding claim 2 directed to the first and/or the second reporter gene encoding fluorescent protein, as discussed above, Ghani et al. utilize GFP and Ho et al. teach the use of GFP for the reporter gene.
Regarding claim 4 directed to the step (iii) wherein the medium being a serum-free medium, Grieger et al. teach that the serum (bovine serum) is used for adapting adherent HEK293 cells to suspension culture condition using SFM4Transfx-293 serum-free suspension media, and subsequently culturing in suspension (p.295, Materials and Methods). As the step (iii) is for culturing cells from the step (ii) of identifying cells for highest transfection efficiency in adherent culture in suspension cell culture, this is viewed as an adaptation of adherent cells to suspension culture and subsequent suspension culture. Thus, it would have been obvious to a person skilled in the art to use a serum-free medium of Grieger et al. for the adapting the selected clones from adherent culture and subsequent suspension culture of the cells with a reasonable expectation of success.
Regarding claim 5, Grieger et al. teach SFM4Transfx293 as discussed above.
Regarding claim 7 directed to the expansion culture medium, in the absence of any definition given to the term, this term is interpreted as any culture medium including the serum-free medium. Furthermore, as Ghani et al. teach that the adaptation of adherently cultured HEK293 cells to the suspension culturing, the cells can be cultured with SFM with less serum until the serum being completely removed from SFM (p.3, 1st col.). Similarly, Grieger et al. teach weaning the cells off of media containing bovine serum and then adapting the cells to SFM4Transfx-293 serum-free suspension media for adaptation to suspension culture (p.295, Materials and Methods). Thus, it would have been obvious to a person skilled in the art to use SFM with reduced amount of serum prior to change to SFM completely free of serum. The SFM with less serum utilized for the adaptation period is considered to meet the “expansion culture medium”.
Regarding claims 10, 14, 17-18 directed to the concentration of cells or plasmids (reporter plasmid and/or virus transfer plasmid), Ghani et al. in view of Grieger et al. and Ho et al. do not particularly teach the claimed concentration. However, Grieger et al. teach that plasmid DNA concentration along with cell density can be optimized (p.289; Fig. 2).
It would have been obvious to a person skilled in the art to modify the concentration of these plasmids for the desired outcome of the screening the clones in the method of Ghani et al. in view of Grieger et al. and Ho et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the concentration of plasmids being utilized for transfection or reporter genes and/or virus proteins for packaging is considered as a result-effective parameter that would be readily modified by routinely optimization as taught by Grieger et al.
Regarding claim 11 directed to the adaptive subculture medium used after the serum free medium, as discussed above, the adaptive subculture medium of claim 11 is interpreted as any culture medium. Thus, the combined teachings of Ghani et al. in view of Grieger et al. and Ho et al. meet the limitation of claim 11.
Regarding claim 12 directed to the culturing cells in the adaptive subculture until cell viability is 93-98%, this limitation is understood that the step (iii) is carried out until the cell viability is to the claimed range in any medium. Ghani et al. teach that the adaptation of adherent HEK293 cells to suspension culture is to achieve overall viability above 95% (p.3, 1st col.). Grieger et al. also teach that the desired viability of HEK293 cells adapted to suspension culture would be >95% (p.295, 1st col.). Thus, it would have been obvious to a person skilled in the art to achieve the cell viability of above 95% during the adaptation to suspension culture of HEK293 cells.
Regarding claim 15 directed to the flow cytometry for measuring the second reporter gene, Ghani et al. teach screening 293GP-A clones for the transduction of the virus packaging plasmid by detecting the GFP fluorescence using FACS analysis (Fig. 3). This would meet the limitation of claim 15.
Regarding claim 16, Grieger et al. teach the use of PEI Max for transfection (p.288, 2nd col.)
Regarding to claim 20 directed to the step (ii) of claim 1 further comprises a step of screening cell clones producing high tier virus in adherent cell culture from the cell clones with high transfection efficiency, Ghani et al. in view of Grieger et al. are directed to the use of suspension adapted HEK293 cells selected for high transfection efficiency for viral transfection and production. However, they do not teach the adherent HKE293 with high transfection efficiency are used for viral production.
Ho et al. teach the use of adherent culture of HEK293 cells for production of lentivirus (see entire document).
It would have been obvious to a person skilled in the art to use the method of Ho et al. for the adherent HEK293 cells selected for the highest transfection efficiency as taught by Grieger et al. A person of ordinary skilled in the art would have been motivated to do so because viral production using adherent HEK293 cells are known in the art according to Ho et al. and one skilled in the art would try the method for production of virus with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghani et al. in view of Grieger et al. and Ho et al. as applied to claim 1 above, and further in view of TurboFect Transfection Reagent (2018, ThermoScientific).
Regarding claim 3 directed to the step (ii) such that the cell fraction of each cell clones is transfected after logarithmic growth phase, Ghani et al. in view of Greiger et al. and Ho et al. do not teach the limitation.
However, it is well known in the art that transfection of adherent cells should be logarithmic growth at the time of transfection according to TurboFect Transfection Reagent (p.1, 2nd col.).
It would have been obvious to a person skilled in the art to ensure that the transfection efficiency assay taught by Grieger et al. is carried out when the cells reach logarithmic growth for the transfection with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 6, 8-9 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghani et al. in view of Grieger et al. and Ho et al. as applied to claims 1, 4 and 7 above, and further in view of Pro293 (2021, Lonza) and GlutaMAX (2020, ThermoFisher Scientific).
Regarding claim 6 directed to the serum-free medium or claim 9 directed to the expansion culture medium comprising 2-8 mM L-glutamine, and claim 8 directed to the expansion medium containing Pro293, Ghani et al. in view of Grieger et al. and Ho et al. do not particularly teach the limitations.
Pro293 from Lonza teaches that Pro293 medium is serum-free and utilized for suspension adaptation for 293 cells (see entire instruction).
It would have been obvious to a person skilled in the art to use Pro293 SFM as a serum free medium replacing SFM4Transfx-293 for the same purpose of adapting adherent HEK293 cells for suspension culture, and one skilled in the art would recognize that Pro293 medium is a suitable alternative to SFM4Transfx-293 according to Pro293.
Regarding the 2-8 mM L-glutamine, Pro293 teach that this medium must be supplemented with 2-4 mM L-glutamine (p.2).
Claim 8 requires 2% (v/v) FBS in addition to Pro293 medium. As discussed above, Pro293 medium can replace SFM4Transfx-293 for suspension culture of HEK293 cells. According to the step of adapting adherent HEK293 cells, Ghani et al. teach that the adaptation of adherently cultured HEK293 cells to the suspension culturing, the cells can be cultured with SFM with less serum until the serum being completely removed from SFM (p.3, 1st col.). Thus, it would have been obvious to a person skilled in the art to use SFM, i.e. Pro293 medium, with reduced serum until the completely removal of serum. Ghani et al. teach the 5% serum for adherent culture and then decreased to 1% during suspension culture (p.3, 1st col.). Similarly, Grieger et al. teach the step of adapting adherent HEK293 cells for suspension culture, and gradually reducing FBS from 10 to 2.5%, and then serum-free suspension media (p.295, 1st col.).
Furthermore, Pro293 teach that the serum depletion and suspension adaptation protocol utilize 2% FBS (p.2). Thus, reduction of FBS to 2% from the higher percentage (5% or 10%) for adherent culture is known in the art.
Based on these teachings, one skilled in the art would recognize that the serum reduction can be gradually from 10% or 5% down to zero and 2% serum would be an obvious serum concentration that can be used in the adaptation procedure.
Regarding claim 19, the medium for the step (i) containing Pro293 medium, 2-8 mM GlutaMax and 2-10% FBS, as discussed above, both Ghani et al. and Grieger et al. teach that adherent culture of HEK293 cells is in the serum containing medium (5% or 10% FBS or other equivalent serum). However, they do not teach the use of Pro293 medium for adherent culture.
Pro293 from Lonza teaches that this medium can be used for adherent culture (see p.1, 2nd col.) as it is utilized for serum depletion protocol for adherent culture.
It would have been obvious to a person skilled in the art to use Pro293 medium for adherent culture because Ghani et al. teach SFM comprising 5% FBS would be used for adherent culture (p.3, 1st col.). It is understood that SFM can be used normal cell culture condition in the presence of serum as it becomes serum-containing medium. Thus, one skilled in the art would utilize an SFM suitable for adherent HEK293 using serum, and Pro293 medium supplemented with 5% or 10% FBS would be used for adherent HEK293 cells with a reasonable expectation of success.
Regarding 2-8 mM GlutaMax, it is well known in the art GlutaMax replaces glutamine at equimolar basis according to GlutaMAX. As Pro293 teaches 2-4 mM glutamine as a necessary supplement, it would have been obvious to use the equimolar, i.e. 2-4 mM, of GlutaMAX as an alternative to L-glutamine for Pro293 medium with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ghani et al. in view of Grieger et al. and Ho et al. as applied to claims 1, 4, 11 above, and further in view of Pro293 (supra), GlutaMAX (supra) and Anti-Clumping Agent (2019, Gibco; ThermoFisher Scientific; downloaded from web.archive.org/web/20191017081939/https://www.thermofisher.com/order/catalog/product/0010057AE)
Regarding claim 13 directed to the adaptive subculture medium of claim 11 being Transpro CD01 medium, 4 mM GlutaMax and 0.1% an anti-clumping agent, Ghani et al. in view of Grieger et al. and Ho et al. do not teach the limitation.
As discussed above, the term “adaptive subculture medium” is interpreted as medium for suspension culture, and thus, the SFM used in suspension culture of HEK293 cells taught by Ghani et al. or Grieger et al. would meet the limitation.
Regarding the term “Transpro CD01”, as it is a tradename, it does not provide any structure to the claimed medium, and thus, it is interpreted as any medium utilized for suspension culture. Thus, the SFM utilized in the method of Ghani et al. in view of Grieger et al. and Ho et al. is considered to meet the limitation.
Furthermore, as Pro293 from Lonza teaches that this medium is suitable for the suspension adaptation purpose of 293 cells (a.k.a. HEK293 cells), one skilled in the art would use Pro293 replacing SFM taught by Ghani et al. and Grieger et al. The Pro293 medium is considered to meet the adaptive medium of claim 13.
Regarding 4 mM GlutaMax, it is well known in the art GlutaMax replaces glutamine at equimolar basis according to GlutaMAX. As Pro293 teaches 2-4 mM glutamine as a necessary supplement, it would have been obvious to use the equimolar, i.e. 2-4 mM, of GlutaMAX as an alternative to L-glutamine for Pro293 medium with a reasonable expectation of success.
Regarding the 0.1% anti-clumping agent, Ghani et al. in view of Grieger et al. and Ho et al. in further view of Pro293 and GlutaMax do not teach the limitation.
Anti-Clumping Agent from Gibco teaches that this liquid agent is utilized to reduces cell clumping to assist in attaining higher viable cell densities in suspension culture (p.1, Description). The reference also teaches the suitable dilution factor being 1:1000 (p.1), which would be 0.1% concentration which meets the claimed concentration.
It would have been obvious to a person skilled in the art to use the anti-clumping agent of Gibco for the purpose of obtaining higher viable cell densities in suspension culture of HEK293 cells for the method of Ghani et al. in view of Grieger et al. and Ho et al. with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
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/TAEYOON KIM/ Primary Examiner, Art Unit 1631
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