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 .
Claim Status
Claims 1-24 are pending and are examined in this office action. Claims 21-24 are added by applicant as new claims. Since the added claims do not add further search burden to examiner they are examined in this office action.
Rejections that are withdrawn
Objection to specification is withdrawn in light of applicant’s amendment of trade names with the proper symbol in commers as TM.
35 USC § 112 Indefiniteness rejection is withdrawn in light of applicant’s amendment of claims 5, 8, 10, 11, 19, 20 to delete the indefinite term “preferably” and by deleting the phrase “(mass of plant cells as dry weight)” from claim 9.
Claim Rejections - 35 USC § 103
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.
Following analysis is modified to analyze newly added claims 21-24.
Obvious over Patent US 9,862,910 B2 and further in view of Fellows et al., Burden et al., PGPUB US 2009/0087448 A1 and Goldberg et al.
Claims 1-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Hassan et al. (US Patent No.: US 9,862,910 B2, Date of Patent: Jan.9,2018) (Hereafter referenced as Patent ‘910), and further in view of Fellows et al. (Published: 2009, Book: Food Processing Technology (Third edition) Principle and Practice, Woodhead Publishing Series in Food Science, Technology and Nutrition 2009, Chapter 10-Heat Processing Pages 339-366), and further in view of Burden et al. (Published: 2012, Journal: Random Primers 12.1 : 1-25), and further in view of Miller et al. (US Patent Application Pub. No. US 2009/0087448 A1, Pub. Date: Apr. 2, 2009) (hereafter referenced as PGPUB ‘448) further in view of Goldberg et al. (Published: 2015, Book: In Proteomic Profiling: Methods and Protocols, pp. 1-20. New York, NY: Springer New York).
Claims are drawn to a method for detaching expressed material from the surface or from the apoplast of plant cells, wherein the plant cells are treated with a rotor-stator in a liquid medium, wherein various specific heat is introduced by rotation of the rotor to the liquid medium with the plant cells.
Regarding claims 1, 5 and 19-20, Patent ‘910 claim 1 teaches a method of processing a medium containing algae microorganisms to produce algal oil and by-products,
comprising providing the medium containing algae microorganisms;
passing said medium through a rotor-stator high shear device;
disintegrating cell walls of and intracellular organelles in the algae microorganisms to release algal oil and byproducts; and
removing the algae medium from an outlet of the high shear device;
Patent ‘910 claim 8 teaches the method further comprise separating algal oil and byproducts from the algal medium removed from the high shear device.
Since any expressed materials contain any secreted material from cell surface (for example claims 5, 19, 20) the oil is material secreted.
Patent ‘910 teaches an approximation of energy input into the fluid (kW/L/min) can be estimated by measuring the motor energy (kW) and fluid output (L/min) (col. 7, lines 6-7).
Patent ‘910 teaches the energy expenditure of HSD 200 (a mechanical device that utilizes one or more generator comprising a rotor/stator combination, having a gap between stator and rotor (col. 5, lines 50-55) is greater than 1000, from 3000-7500 watts per cubic meter of fluid therein which is equivalent to 1, and 3 to 7.5 kJ/sec (col. 7, lines 12-16).
Furthermore, Fellows et al. teaches the liquid medium for example water has the specific heat capacity of 4.18 kJ/Kg wherein the specific heat capacity of other liquids and different plant foods were lower (pages 29, Table 10.1), Fellows et al. teaches the specific heat of foods depends on their composition, especially the moisture content (Equation 10.2) (page 4, paragraph 1). Therefore, it would have been obvious to maintain the lower KJ/Kg to maintain the chemical integrity of the expressed materials from the cells.
Burden et al. teaches rotor-stators can generate heat thus temperature probes are used in the homogenization techniques (page 14, paragraph 3). Therefore, it would have been obvious to maintain the specific heat from the rotor stator introduced by rotation of rotor to maximum of 3 kJ per kg of liquid medium and maintain the specific heat capacity introduced into the medium to be maximum of 1.5 kJ per kg of liquid medium.
The amount of specific heat introduced by rotor-stator and specific heat capacity introduction to the liquid medium with cells are empirically determined and is an optimization of process parameters. According to section 2144.05 of the MPEP, “[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). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
A particular parameter must first be recognized as a result-effective variable, i.e., a variable, which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Prior arts teach the use of rotor-stator to separate the expressed proteins or materials from plant cells, therefore, determining the specific heat introduction to a medium with plant cell is routine experimentation.
Furthermore, the principle of specific heat capacity would have been used to calculate the energy input (as heat) into a liquid medium, like water, when using the homogenizer. Fellows et al. teaches the specific heat of a substance (c) is the amount of heat energy required to raise the temperature of a 1 kg of that substance by one degree Celsius (page 2, first paragraph).
Goldberg et al. teases for cell wall disruption or lysis of plants cell wall and cell membranes by rotor/stator=shear by spinning shaft has been used (see page 3, Table 2, see table below). Therefore, it was known in the art the method can be used for cell membrane or cell wall disruption of the plant cells.
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Goldberg et al. teaches by judicious use of the equipment one can select from a gentle nicking of the cell to release intact organelle up to a vigorous action to release membrane bound proteins (page 2, paragraph 2).
Furthermore, PGPUB ‘448 claim 1, 8, 9, 13, 15 teaches method of separating expressed biologically active protein particles expressed in a transgenic plant cell, wherein claim 5 teaches the method of physical and mechanical disruption is performed by high shear rotor stator or homogenization. PGPUB ‘448 teaches the location of the protein near the cell wall and membranes helps to explain the unexpected ability to isolate the protein easily with mechanical disruption (page 17, paragraph 0145). Therefore it would have been obvious to choose the rotor stator or homogenization for the effective separation of the protein expressed from the cell surface.
Therefore it would have been obvious to try- choosing from a finite number of identified and predictable specific heat from the rotor stator introduced by rotation of rotor and maintain it to be maximum of 3kJ per kg of the liquid medium and maintain the specific heat capacity introduced to the medium to be maximum of 1.5 kJ per kg of liquid medium and per g/L dry weight of the plant cels, so that the integrity of the expressed materials from the cell surface are maintained to be detached from the surface, thus teaching, suggestion and motivation of Patent ‘910 that showed the method of extracting the algal oil from the algal cells and Fellows et al. teaches the specific heat capacity of different liquids and fruits and vegetables varies. This known work in the field of cell lysis would prompt variation to be used in the plant since PGPUB ‘448 and Goldberg et al. teaches the method can be used in plants for releasing membrane bound protein which would have more economic advantage because of economic value of the plants and their extracted materials wherein the variation are predictable to one of ordinary skill in the art.
Regarding claim 2, Applicant states apoplast are totality of cell walls and intercellular space (page 3, line 13-14). Goldberg et al. teaches for cell wall disruption or lysis of plants cell wall and cell membranes by rotor/stator=shear by spinning shaft has been used (see page 3, Table 2, see table below).
Regarding claim 4, the specific heat capacity into the medium is at least 0.02 kJ per kg of the liquid medium per minute and per g/L of dry weight of the plant cells would have been obvious to try for the variation in the specific heat capacity of the liquid medium and other plant parts as described by Fellows et al.
Regarding claims 3, 13 and 16-18, Goldberg et al. teaches excessive force is limited due to the generation of detrimental heat and/or shear that can ruin the desired proteins, wear and damage the equipment (page 2, first paragraph). Thus, a specific heat is generated during the shearing process that can be manage to introduce to the liquid medium in specific amount required by the separating expressed materials.
Furthermore, Fellows et al. teaches the liquid medium for example water has the specific heat capacity of 4.18 kJ/Kg wherein the specific heat capacity of other liquids and different plant foods were lower (pages 2 and 3, Table 10.1). Fellows et al. teaches the specific heat of foods depends on their composition, especially the moisture content (Equation 10.2) (page 4, paragraph 1) therefore it would have been obvious to maintain the lower KJ/Kg to maintain the chemical integrity of the expressed materials from the cells.
Regarding claim 6, Patent ‘910 claim 1 teaches passing said medium through a rotor-stator high shear device. The medium would be in a container.
Regarding claim 7, Patent ‘910 teaches rotor stator high shear device comprise an inlet to take in the medium containing algae microorganisms and an outlet for the algae medium to be removed from the high shear device (col.2, lines 45-49).
Regarding claims 8 and 22, Goldberg et al. teaches rotor-stator homogenizers currently available can process sample volume of less than 0.5 mL up to 150,000 L (page 9, paragraph 3) which is equivalent to the range of 0.0005kg to 150 kg in terms of water.
Regarding claim 9, Patent ‘910 teaches algal culture density reached 2 g/L (col. 17, line 14).
Regarding claim 10, Goldberg et al. teases for cell wall disruption or lysis of plants cell wall and cell membranes by rotor/stator=shear by spinning shaft has been used (see page 3, Table 2, see table below) wherein a moss is a plant.
Regarding claims 11 and 24, Patent ‘910 teaches at speed of 14000 rpm the cell lysis of algae vs. yeast cell was found to have 16% reduction in cell number (col. 27, lines 1-25, see Table 1 below).
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Regarding claim 12, Patent ‘910 teaches shear pump in Figure 5 in their method of process for algae lysing and algal oil recovery.
Regarding claim 14, Patent ‘910 teaches pH of the medium like distilled water is 7 (col. 16, line 14) and 5-8 (col. 18, lines 13-14)
Regarding claim 15, Patent ‘910 teaches the circulation time of at least 2 min (col. 27, table 1, see table above).
Regarding claim 21, PGPUB ‘448 teaches the location of the protein near the cell wall and membranes helps to explain the unexpected ability to isolate the protein easily with mechanical disruption (page 17, paragraph 0145).
Obvious over Patent US 9,862,910 B2 and further in view of Fellows et al., Burden et al., PGPUB US 2009/0087448 A1, Goldberg et al. and Schaewen et al.
Claims 1, 11 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Hassan et al. (US Patent No.: US 9,862,910 B2, Date of Patent: Jan.9,2018) (Hereafter referenced as Patent ‘910), and further in view of Fellows et al. (Published: 2009, Book: Food Processing Technology (Third edition) Principle and Practice, Woodhead Publishing Series in Food Science, Technology and Nutrition 2009, Chapter 10-Heat Processing Pages 339-366), and further in view of Burden et al. (Published: 2012, Journal: Random Primers 12.1 : 1-25), and further in view of Miller et al. (US Patent Application Pub. No. US 2009/0087448 A1, Pub. Date: Apr. 2, 2009) (hereafter referenced as PGPUB ‘448) further in view of Goldberg et al. (Published: 2015, Book: In Proteomic Profiling: Methods and Protocols, pp. 1-20. New York, NY: Springer New York), and further in view of Schaewen et al. (US Application Pub. No.: US 2011/0047657 A1, Pub. Date: Feb. 24, 2011).
Regarding claim 1, Patent ‘910 claim 1 teaches a method of processing a medium containing algae microorganisms to produce algal oil and by-products,
comprising providing the medium containing algae microorganisms;
passing said medium through a rotor-stator high shear device;
disintegrating cell walls of and intracellular organelles in the algae microorganisms to release algal oil and byproducts; and
removing the algae medium from an outlet of the high shear device;
Patent ‘910 claim 8 teaches the method further comprise separating algal oil and byproducts from the algal medium removed from the high shear device.
Since any expressed materials contain any secreted material from cell surface (for example claims 5, 19, 20) the oil is material secreted.
Patent ‘910 teaches an approximation of energy input into the fluid (kW/L/min) can be estimated by measuring the motor energy (kW) and fluid output (L/min) (col. 7, lines 6-7).
Patent ‘910 teaches the energy expenditure of HSD 200 (a mechanical device that utilizes one or more generator comprising a rotor/stator combination, having a gap between stator and rotor (col. 5, lines 50-55) is greater than 1000, from 3000-7500 watts per cubic meter of fluid therein which is equivalent to 1, and 3 to 7.5 kJ/sec (col. 7, lines 12-16).
Furthermore, Fellows et al. teaches the liquid medium for example water has the specific heat capacity of 4.18 kJ/Kg wherein the specific heat capacity of other liquids and different plant foods were lower (pages 29, Table 10.1), Fellows et al. teaches the specific heat of foods depends on their composition, especially the moisture content (Equation 10.2) (page 4, paragraph 1). Therefore, it would have been obvious to maintain the lower KJ/Kg to maintain the chemical integrity of the expressed materials from the cells.
Burden et al. teaches rotor-stators can generate heat thus temperature probes are used in the homogenization techniques (page 14, paragraph 3). Therefore, it would have been obvious to maintain the specific heat from the rotor stator introduced by rotation of rotor to maximum of 3 kJ per kg of liquid medium and maintain the specific heat capacity introduced into the medium to be maximum of 1.5 kJ per kg of liquid medium.
The amount of specific heat introduced by rotor-stator and specific heat capacity introduction to the liquid medium with cells are empirically determined and is an optimization of process parameters. According to section 2144.05 of the MPEP, “[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). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
A particular parameter must first be recognized as a result-effective variable, i.e., a variable, which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Prior arts teach the use of rotor-stator to separate the expressed proteins or materials from plant cells, therefore, determining the specific heat introduction to a medium with plant cell is routine experimentation.
Furthermore, the principle of specific heat capacity would have been used to calculate the energy input (as heat) into a liquid medium, like water, when using the homogenizer. Fellows et al. teaches the specific heat of a substance (c) is the amount of heat energy required to raise the temperature of a 1 kg of that substance by one degree Celsius (page 2, first paragraph).
Goldberg et al. teases for cell wall disruption or lysis of plants cell wall and cell membranes by rotor/stator=shear by spinning shaft has been used (see page 3, Table 2, see table below). Therefore, it was known in the art the method can be used for cell membrane or cell wall disruption of the plant cells.
Goldberg et al. teaches by judicious use of the equipment one can select from a gentle nicking of the cell to release intact organelle up to a vigorous action to release membrane bound proteins (page 2, paragraph 2).
Furthermore, PGPUB ‘448 claim 1, 8, 9, 13, 15 teaches method of separating expressed biologically active protein particles expressed in a transgenic plant cell, wherein claim 5 teaches the method of physical and mechanical disruption is performed by high shear rotor stator or homogenization. PGPUB ‘448 teaches the location of the protein near the cell wall and membranes helps to explain the unexpected ability to isolate the protein easily with mechanical disruption (page 17, paragraph 0145). Therefore, it would have been obvious to choose the rotor stator or homogenization for the effective separation of the protein expressed from the cell surface.
Therefore, it would have been obvious to try- choosing from a finite number of identified and predictable specific heat from the rotor stator introduced by rotation of rotor and maintain it to be maximum of 3kJ per kg of the liquid medium and maintain the specific heat capacity introduced to the medium to be maximum of 1.5 kJ per kg of liquid medium and per g/L dry weight of the plant cels, so that the integrity of the expressed materials from the cell surface are maintained to be detached from the surface, thus teaching, suggestion and motivation of Patent ‘910 that showed the method of extracting the algal oil from the algal cells and Fellows et al. teaches the specific heat capacity of different liquids and fruits and vegetables varies. This known work in the field of cell lysis would prompt variation to be used in the plant since PGPUB ‘448 and Goldberg et al. teaches the method can be used in plants for releasing membrane bound protein which would have more economic advantage because of economic value of the plants and their extracted materials wherein the variation are predictable to one of ordinary skill in the art.
Regarding claim 10, Goldberg et al. teases for cell wall disruption or lysis of plants cell wall and cell membranes by rotor/stator=shear by spinning shaft has been used (see page 3, Table 2, see table below) wherein a moss is a plant.
Regarding claim 23, Schaewen et al. claim 13 teaches method of developing transgenic plant and plant cell with glycoprotein and isolating the protein. Schaewen et al. claim 19 teaches the isolating of the glycoprotein is from apoplast, a cell wall etc. Furthermore, Schaewen et al. teaches the suitable plant is a moss Physcomitrella patens (page 4, paragraph 0037). Schaewen et al. teaches isolation of glycoproteins is important for medicine research (page 1, paragraph 0006).
Therefore skilled in the art would use the transgenic Physcomitrella patens with the glycoprotein in apoplast for isolating the protein as taught by Schaewen et al. It would have been obvious to isolate using the obvious method taught by Patent ‘910, Fellows et al., Burden et al., PGPUB ‘448 and Goldberg et al. leading to that the integrity of the expressed materials from the cell surface are maintained to be detached from the surface.
Response to Argument for Rejection Under 35 U.S.C. § 103
Applicant's arguments 10/14/2025 have been fully considered but they are not persuasive.
Applicant argues US '910 discloses extraction of algal oil and byproducts from algae microorganisms using a rotor-stator shear device that disrupts cell walls and intracellular organelles. Applicant argues the process intentionally destroys the protoplast to release oil and cellular contents. Applicant argues the examiner equates the "oil" of US '910 to the "expressed material" of the invention and interprets the reported energy expenditure (3000-7500 W/m3) as equivalent to 3-7.5 kJ/sec. Applicant respectively submits that this interpretation is scientifically incorrect (Response to Rejection, page 9, second to last paragraph).
Applicant argues US '910 specifies power density in W/m3, which is joules per second per cubic meter (J/sec·m3), not energy per time (kJ/sec). Applicant argues these units are not directly convertible, as the denominator term (m3) cannot be removed (Response to Rejection, page 10, last paragraph). Applicant argues therefore, the Examiner's derivation of "1 to 7.5 kJ/sec" is erroneous and unsupported by the reference (Response to Rejection, page 11, first paragraph).
Applicant argues the Examiner further relies on Fellows, which reports specific heat capacities of liquids and foods. Applicant argues Table 10.1 of Fellows lists these values in units of kJ·kg-1 0C-1. Applicant argues the Examiner’s assertion that this data supports adjusting the energy input in US '910 to "maintain the chemical integrity" of expressed materials is incorrect for several reasons. Applicant argues First, the cited units were misinterpreted as kJ/kg rather than kJ·kg-1 0C-1, i.e. the units of C-1 appear to have been overlooked. Applicant argues Second, the data relates to thermophysical properties of bulk materials, not to mechanical energy input or shearing conditions of the type disclosed in US '910. Applicant argues third, there is no motivation to modify the teachings of US '910 based on Fellows, since the two references concern entirely distinct systems and objectives. Applicant argues US '910 seeks to destroy algal cells for oil recovery, while Applicants' invention aims to maintain protoplast integrity. Applicant argues the Examiner’s conclusion that it would be "obvious to maintain a lower kJ/kg" is thus a non sequitur unsupported by any factual or technical basis (Response to Rejection, page 10, second paragraph).
Applicant argues the Examiner next relies on Burden, which discloses that rotor-stator homogenizers may generate heat and that temperature probes are used to prevent excessive heating. Applicant asserts Burden merely teaches the use of temperature probes to shut down the device when extreme temperature rises occur. Applicant argues the Examiner's conclusion that "it would have been obvious to maintain the specific heat from the rotor stator to a maximum of 3 kJ/kg and 1.5 kJ/kg" has no support in the reference. Applicant argues No such numerical limits appear anywhere in Burden The values recited in the present claims are not limits to avoid "extreme" heating but are deliberately selected moderate levels designed to remove the apoplast while preserving the protoplast, as described in Applicants' published application US 2024/0025943 Al, paragraph [0011]. Applicant argues this purpose is contrary to the objective of '910, which teaches violent cell destruction to obtain intracellular products. Applicant argues the reasoning proposed by the Examiner is therefore inconsistent with the disclosures of the cited art (Response to Rejection, page 10, third paragraph).
Applicant argues the Examiner further relies on Goldberg and PG PUB '448 to argue that the amount of heat introduced into a system to separate expressed proteins from plant cells would be a matter of routine optimization. Applicant asserts Goldberg describes mechanical methods of lysing cells and recognizes that such methods may be harsh and destroy proteins, recommending moderation to avoid excessive heat and shear. Applicant asserts PG PUB '448 concerns the production of recombinant proteins in transgenic plant cells and discusses accumulation near cell membranes to facilitate isolation. Applicant argues However the combination of these references with US '910 is improper (Response to Rejection, page 10, last paragraph).
Applicant argues US '910 teaches complete cellular destruction, not gentle detachment of expressed materials while maintaining cell integrity. Applicant argues PG PUB '448 does not teach maintaining the protoplast or controlling homogenization parameters for selective detachment. Applicant asserts Goldberg merely advises avoiding extreme heat, not the mild and specific energy ranges claimed herein. Applicant argues the Examiner's combination of these references is therefore based on hindsight reconstruction and not on any teaching, suggestion, or motivation present in the prior art (Response to Rejection, page 11, first paragraph).
Applicants also clarify that the term "heat capacity" in the claims is intended to mean “heat output," consistent with the original meaning in the German-language application. Applicant argues the defined units (kJ per kg of liquid medium and per g/L of dry weight of plant cells) clearly indicate relative heat generation, not thermodynamic specific heat capacity (kJ·kg-1 0C-1). Applicant argues accordingly, Fellows is not pertinent to the claimed parameters, and its discussion of specific heat capacity is unrelated to the concept of heat output as claimed (Response to Rejection, page 11, second paragraph).
Applicant argues in view of the foregoing, the cited references are directed to different objectives, operate under incompatible conditions, and do not provide any teaching or suggestion to arrive at Applicants' claimed process. Applicant argues the Examiner's reasoning relies on incorrect unit conversions, mischaracterization of reference disclosures, and hindsight reconstruction based on Applicants' own teachings.
Regarding argument on the "oil" of US '910 to the "expressed material" of the invention are not same is not found persuasive since there is no definition of expressed materials in specification. Applicant described expressed material is obtained from the surface of the cells or the apoplast (totality of cell walls and intercellular space) wherein the material of this type usually reaches these sites by secretion. Furthermore, claim 5 recites the expressed material could be any secreted material. Therefore, algal oil and byproducts would be one of the expressed materials. Although the conversion would require the specific volume being considered, however claim would enable any volume, any plant cell, any liquid medium that would vary based on their properties. Furthermore, claim would require any specific heat any smaller value or equal to 3KJ per kg introduced by rotor and output of any value smaller than 1.5 kJ per kg of the liquid medium would be comprised in the claim 1 and as small as 0.1 kJ per kg in claim 3 and 0.02kJ in claim 4. Furthermore, the specific heat introduced from rotor-stator and specific heat output introduced into the medium would have been a matter of adjustments in the method of US '910.
The amount of specific heat introduced by rotor-stator and specific heat capacity introduction to the liquid medium with cells are empirically determined and is an optimization of process parameters. According to section 2144.05 of the MPEP, “[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). See also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”).
A particular parameter must first be recognized as a result-effective variable, i.e., a variable, which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). Prior arts teach the use of rotor-stator to separate the expressed proteins or materials from plant cells, therefore, determining the specific heat introduction to a medium with plant cell is routine experimentation.
Regarding argument on the Fellow et al. was not found persuasive since specific heat of the many of the plant materials as showed in 10.1 are below 4.06 Kj Kg -1 C-1. It would have taught a skilled in the art to introduce lower specific heat to maintain their protoplast integrity the specific value would have been the characterized from routine experimentation. The motivation would be to maintain the protoplast integrity as analyzed above.
Regarding argument on Burden et al. does not show numerical value for specific heat is not persuasive since Burden et al. teaches rotor-stators can generate heat thus temperature probes are used in the homogenization techniques (page 14, paragraph 3), furthermore suggestion from Fellow et al. of plant material has low specific heat, the specific value would have been the characterized from routine experimentation.
Regarding argument on the combination of PG PUB '448 and Goldberg is not found persuasive since both methods teach use of rotor stator for separating expressed biologically active protein particles expressed in a transgenic plant cell wherein applicant claim 5 recite the expressed material can by any secreted material or proteins.
Conclusion
No claim is allowed.
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.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SANTOSH SHARMA whose telephone number is (571)272-8440. The examiner can normally be reached Mon-Fri 8:00 AM - 5:00 PM.
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/SANTOSH SHARMA/Examiner, Art Unit 1663
/DAVID H KRUSE/Primary Examiner, Art Unit 1663