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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date of the instant application is 01/15/2021.
Withdrawal of Rejections
The response and amendments filed on 03/10/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous claims rejections under 35 U.S.C. 112(b) for indefiniteness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below. The previous claim rejections under 35 U.S.C. 101 for non-statutory subject matter has been withdrawn necessitated by Applicant’s amendments. The previous claim rejections under 35 U.S.C. 103 for obviousness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 1 is objected to because of the following informalities: “pectiase” should be “pectinase”. Appropriate correction is required. This is an objection, not a rejection, because this appears to be a typographical error.
Claim 1 is objected to because of the following informalities: claim 1 reads as one long run on sentence. It is recommended that Applicant re-write the claim into a listed number of steps, especially if the steps are to be performed in a specific order. Appropriate correction is required. This is an objection, not a rejection, because this appears to be a typographical error.
Claims 4-5 are objected to because of the following informalities: Latin scientific names should be italicized. Appropriate correction is required. This is an objection, not a rejection, because this appears to be a typographical error.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 112(b), Indefiniteness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 4-5 are rejected under 35 U.S.C. 112(b) 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 1 recites “1-5 kg of powder dissolved in a small amount of water”; however, it is unclear what “a small amount of water is” and the instant specification does not define what the amount of water is that the potassium sorbate is dissolved in. One of ordinary skill in the art would not be able to determine if they are infringing on the claimed invention, nor would they reasonably be apprised of the scope of the claimed invention, because the instant specification and claims do not define what a “small amount of water” would be. For the purposes of applying prior art, the Examiner has interpreted “a small amount of water” to be any amount of water needed to completely dissolve the potassium sorbate.
Claims 4 and 5 recite “selected from the group of”; however, it is unclear if one pathogen is to be selected from this group, or if multiple combinations of pathogens are to be selected from this group. If Applicant is attempting to use Markush language, Applicant should amend the claims to recite “selected from the group consisting of” (see, e.g., MPEP 2117). For the purposes of applying prior art, the Examiner has interpreted one pathogen to be selected from the list of pathogens.
Claim 4 recites different pathogens in parentheses; however, it is unclear if the pathogens recited in the parentheses are part of the claimed invention, or a preferred embodiment. For the purposes of applying prior art, the Examiner has interpreted the pathogens recited in parentheses to be preferred embodiments.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Iwasaki (“Continuous Hydrolysis of Pectate by Immobilized Endo-polygalacturonase in a Continuously Stirred Tank Reactor; 1998 – cited in the IDS filed on 06/29/2023 – herein referred to as “Iwasaki 1998” – previously cited) in view of Iwasaki (“Purification of Pectate Oligosaccharides Showing Root-Growth-Promoting Activity in Lettuce Using Ultrafiltration and Nanofiltration Membranes”; 2000 – cited in the IDS filed on 06/29/2023 – herein referred to as “Iwasaki 2000” – previously cited), Perez-Martinez (“Characteristics of Pectin from Opuntia ficus indica Cladode Flour”; 2013 – cited in the IDS filed on 06/29/2023 – previously cited), and Kerovuo (US 2006/0210971; Date of Publication: September 21, 2006 – previously cited).
Iwasaki 1998’s general disclosure relates to a method for continuous enzymatic hydrolysis of pectate in order to “produce pectate oligosaccharides by immobilized endo-polygalacturonase in a continuous stirred tank reactor (CSTR) with high efficiency” (see, e.g., Iwasaki 1998, abstract). Moreover, Iwasaki discloses that the continuous hydrolysis method was used to obtain oligosaccharides with various degrees of polymerization (DPs) (see, e.g., Iwasaki 1998, Introduction). Furthermore, Iwasaki discloses that the productivity of a continuous enzymatic hydrolysis operation is higher than that in batch operation and the CSTR system has the practical advantage of being able to reuse the enzyme (see, e.g., Iwasaki 1998, Productivity, pgs. 266-267).
Regarding claim 1 pertaining to a method of obtaining a oligogalacturonides preparation, Iwasaki 1998 teaches “a continuous hydrolysis of pectate was carried out to obtain with high efficiency pectate oligosaccharides with various DPs by an immobilized endo-polygalacturonase in a continuous stirred tank reactor (CSTR)” (see, e.g., Iwasaki 1998, Introduction, pg. 262). Iwasaki 1998 teaches “The CSTR system is made up of a feed tank, reactor tank, pump, receiver, electric weight for balance, and controller for temperature and agitation” (see, e.g., Iwasaki 1998, Apparatus, pg. 263); therefore, one of ordinary skill in the art would recognize that the “controller for temperature” is equivalent to a “heating system”, as claimed. Moreover, using commercial citrus pectin (see, e.g., Iwasaki 1998, Materials, pg. 262), Iwasaki 1998 teaches “A pectate solution was prepared from the pectin according to the method of Goto et al., the pectin being saponified in 0.05N NaOH at 70-80oC for 5 h, and the pH value of the solution being adjusted to 5.0 with 1N HCl (see, e.g., Iwasaki 1998, Materials, pg. 262). One of ordinary skill in the art would readily understand and calculate that 0.05N NaOH results in a pH of 12.7, which is approaching the claimed range of pH 12.0 and therefore prima facie obvious (see, e.g., MPEP 2144.05(I)). Moreover, one of ordinary skill in the art would readily understand that 1N HCl would decrease the pH from 12.0 to 5.0; therefore, HCl can be substituted for citric acid, since both HCl and citric acid are acids used to decrease the pH of a solution, and both HCl and citric acid can decrease the pH to 5.0, as claimed. Furthermore, Iwasaki 1998 teaches that a final product containing the oligogalacturonides is pooled, concentrated in a rotary evaporator and freeze dried; therefore, the final product is in a solid form (see, e.g., Iwasaki 1998, Chemical analysis, pg. 263). Iwasaki 1998 teaches that the pectin is from citrus pectin (see, e.g., Iwasaki 1998, Materials, pg. 262). Iwasaki 1998 teaches that the pectinolytic enzyme is endo-polygalacturonase from Aspergillus pulverulentus (see, e.g., Iwasaki 1998, Materials, pg. 262).
However, Iwasaki 1998 does not teach: a degree of polymerization from 2 to 10 (claim 1); wherein water and 40% tetrasodium ethylenediaminetetraacetate solution are added to the reactor (claim 1); or wherein 0.1% pectinolytic enzyme is introduced (claim 1); or heating to a temperature of 80oC for 30 minutes until the enzyme deactivates (claim 1); or adding potassium sorbate comprising 1-5 kg of powder dissolved in a small amount of water to the cooled reaction mixture (claim 1).
Iwasaki 2000’s general disclosure relates to separating pectate oligosaccharides from enzymatically hydrolyzed pectate by using ultrafiltration (UF) and nanofiltration (NF) membranes (see, e.g., Iwasaki 2000, abstract). Moreover, Iwasaki 2000 discloses methods enzymatically hydrolyzing citrus pectin using 0.1% endopolygalacturonase in a batch reaction, wherein, after hydrolysis, solution obtained from the batch reaction is filtered (see, e.g., Iwasaki 2000, pg. 495, col. 2). Furthermore, Iwasaki 2000 discloses formulating the purified oligosaccharide preparation into a dried powder and examining root-growth-promoting activity of the preparation at different degrees of polymerization (see, e.g., Iwasaki 2000, pg. 496 & Figure 2).
Regarding claim 1 pertaining to the method of preparation, Iwasaki 2000 teaches experiments with pectate oligogalacturonide mixtures with degrees of polymerization between 1-6 (see, e.g., Iwasaki 2000, Figure 2). Iwasaki 2000 teaches 0.1% endo-polygalacturonase from Aspergillus pulverulentus (see, e.g., Iwasaki 2000, pg. 492, col. 2). Iwasaki 2000 teaches that the enzymatic reaction was stopped by heating the solution in boiling water for 15 min (see, e.g., Iwasaki 2000, pg. 492, col. 2).
Perez-Martinez’s general disclosure relates to extracting pectin from the cladode flour of Opuntia ficus indica using different ethylenediaminetetraacetate (EDTA) concentrations (10 or 20%), temperatures (40 or 80oC), pH values (2 or 11), and times (10, 20, 30, 40, 50, or 60 min) (see, e.g., Perez-Martinez, abstract). Moreover, Perez-Martinez discloses that the highest pectin yield was observed under alkaline conditions and 20% EDTA (see, e.g., Perez-Martinez, abstract). Furthermore, Perez-Martinez discloses “pectin produced from alkaline extractions has a lower content of GalA than pectin produced from acidic extractions. Higher temperatures favored the extraction of pectin under acid conditions, but these conditions diminished the arabinose content of pectins in a time-dependent manner” (see, e.g., Perez-Martinez, abstract).
Regarding claim 1 pertaining to the 40% tetrasodium ethylenediaminetetraacetate (EDTA) solution, Perez-Martinez teaches using 10% and 20% EDTA within the solution at acidic and alkaline pH (see, e.g., Perez-Martinez, Pectin Extraction).
Kerovuo’s general disclosure relates to “polypeptides having pectate lyase (pectinase) activity, polynucleotides encoding the polypeptides, and methods for making and using these polynucleotides and polypeptides. The polypeptides of the invention can be used as pectate lyases to catalyze the beta-elimination or hydrolysis of pectin and/or polygalacturonic acid, such as 1,4-linked alpha-D-galacturonic acid” (see, e.g., Kerovuo, abstract). Moreover, Kerovuo discloses that pectate lyases can be used to treat plant cell walls (see, e.g., Kerovuo, [0002]), and the preparation containing pectate lyase can be in a lyophilized form (see, e.g., Kerovuo, [0097]).
Regarding claim 1 pertaining to the potassium sorbate, Kerovuo teaches that the pectate lyase lyophilized composition contains 0.1% potassium sorbate (see, e.g., Kerovuo, [0097]), wherein the potassium sorbate is used as an additive in the composition for stability (see, e.g., Kerovuo, [0560]). Furthermore, Kerovuo teaches that the formulation is water-based (see, e.g., Kerovuo, [0097]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce OGA according to Iwasaki 1998’s methods, wherein the enzymatic reaction is deactivated by heating, as taught by Iwasaki 2000. One would have been motivated to do so because Iwasaki 2000 teaches that the enzymatic reaction was stopped by heating the solution in boiling water for 15 minutes (see, e.g., Iwasaki 2000, pg. 495, col. 2), which one of ordinary skill in the art would understand means that the endopolygalacturonase enzyme is deactivated at high temperatures. Moreover, Iwasaki 1998 teaches that endopolygalacturonase is used to hydrolyze pectate to produce pectate oligosaccharides (see, e.g., Iwasaki 1998, abstract). Furthermore, one of ordinary skill in the art would readily understand that boiling water would be at 100oC for 15 minutes would deactivate or stop the enzymatic reaction; therefore, one of ordinary skill in the art would understand that if the reaction is deactivated at 80oC, that more time, such as the claimed 30 minutes, would be needed to deactivate the enzymatic reaction which would result in a stop in the hydrolyzation of pectate and a stop in the production of pectate oligosaccharides. One would have expected success because Iwasaki 1998 and Iwasaki 2000 both teach methods of producing OGA from citrus pectin.
It would have been secondly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce OGA according to Iwasaki 1998’s methods, wherein the percentage of EDTA in the reaction mixture is 10-20%, as taught by Perez-Martinez. One would have been motivated to do so because Perez-Martinez teaches the highest pectin yield was observed under alkaline conditions and 20% EDTA (see, e.g., Perez-Martinez, abstract). Furthermore, Perez-Martinez discloses “pectin produced from alkaline extractions has a lower content of GalA than pectin produced from acidic extractions. Higher temperatures favored the extraction of pectin under acid conditions, but these conditions diminished the arabinose content of pectins in a time-dependent manner” (see, e.g., Perez-Martinez). Moreover, Iwasaki 1998 teaches the production of pectate oligosaccharides by continuous hydrolysis of pectin (see, e.g., Iwasaki 1998, Introduction). Therefore, based on the teachings of Iwasaki 1998 and Perez-Martinez, it would have been obvious to increase the percentage of EDTA in the reaction mixture because increasing the percentage of EDTA under alkaline conditions would result in higher yield of pectin, wherein the pectin can be hydrolyzed to produce pectin oligosaccharides and pectin oligogalacturonides. One would have expected success because Iwasaki 1998 and Perez-Martinez both teach extraction of pectin oligosaccharides from plants.
It would have been thirdly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to product OGA according to Iwasaki 1998’s methods, wherein the preparation contains potassium sorbate, as taught by Kerovuo. One would have been motivated to do so because Kerovuo teaches that potassium sorbate can be added to lyophilized compositions for stability of the product (see, e.g., Kerovuo, [0097], [0560]). Moreover, Iwasaki 1998 teaches pooling, concentrating, and lyophilizing the pectin oligosaccharides derived from pectin hydrolysis (see, e.g., Iwasaki 1998, Chemical Analysis, pg. 263), wherein one of ordinary skill in the art would understand that the lyophilized pectin oligosaccharides need to be preserved. Therefore, based on the teachings of Iwasaki 1998 and Kerovuo, it would have been obvious to produce an OGA composition comprising potassium sorbate in order to enhance the stability of the lyophilized OGA preparation. One would have expected success because Iwasaki and Kerovuo both teach methods of hydrolyzing pectin.
Regarding claims 4 and 5 pertaining to the plant stimulating activity via application of the OGA preparation, these claims are considered intended use. The combined prior art of Iwasaki 1998, Iwasaki 2000, Perez-Martinez, and Kerovuo teach the claimed preparation method for OGA; therefore, the preparation would be capable of having plant biostimulating effects and a enhancing plant resistance.
Regarding the EDTA percentage limitations in claim 1, those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular working conditions (e.g., concentrations, percentages, etc.) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan (see, e.g., MPEP 2144.05). For example, Perez-Martinez teaches the percentage of EDTA and the pH of the extraction conditions results in different yields of pectin (see, e.g., Perez-Martinez, Introduction). Moreover, Perez-Martinez discloses that the highest pectin yield was observed under alkaline conditions and 20% EDTA (see, e.g., Perez-Martinez, abstract). Furthermore, Perez-Martinez discloses “pectin produced from alkaline extractions has a lower content of GalA than pectin produced from acidic extractions. Higher temperatures favored the extraction of pectin under acid conditions, but these conditions diminished the arabinose content of pectins in a time-dependent manner” (see, e.g., Perez-Martinez, abstract). Therefore, one of ordinary skill in the art would reasonably understand that increasing the concentration of EDTA and manipulating the pH of the extraction to make the pH more alkaline would result in increased pectin yields, wherein the pectin can be hydrolyzed to produce pectin oligosaccharides. This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the percentage of EDTA, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Regarding the potassium sorbate limitation in claim 1, those working in the biological and/or pharmaceutical arts would understand that the adjustments of particular working conditions (e.g., concentrations, percentages, etc.) is deemed a matter of judicious selection and routine optimization, which is within the purview of the skilled artisan (see, e.g., MPEP 2144.05). For example, Kerovuo teaches a buffer comprising 0.1% potassium sorbate, wherein the formulation is water-based (see, e.g., [0097]); therefore, one of ordinary skill in the art would readily be able to extrapolate that the potassium sorbate could initially comprise 1-5 kg of powder. Furthermore, Kerovuo teaches that the potassium sorbate is used as an additive in the composition for stability (see, e.g., Kerovuo, [0560]). This is motivation for someone of ordinary skill in the art to practice or test the parameter widely to find those that are functional or optimal which then would be inclusive or cover the steps as instantly claimed. Absent any teaching of criticality by the Applicant concerning the percentage of EDTA, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are result effective variables which can be met as a matter of routine optimization.
Examiner’s Response to Arguments
Applicant's arguments filed 03/10/2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that the combination of Iwasaki 1998, Iwasaki 2000, Perez-Martinez, and Kerovuo is improper (remarks, page 8), this argument is not persuasive because, as discussed above, Iwasaki 1998, Iwasaki 2000, Perez-Martinez, and Kerovuo teach each and every limitation of the claimed invention. Iwasaki 2000 was cited to teach the degrees of polymerization, the percentage of polygalacturonase, and stopping the enzymatic reaction by heating. Iwasaki 2000 teaches that the enzymatic reaction was stopped by heating the solution in boiling water for 15 minutes (see, e.g., Iwasaki 2000, pg. 495, col. 2), which one of ordinary skill in the art would understand means that the endopolygalacturonase enzyme is deactivated at high temperatures. Moreover, Iwasaki 1998 teaches that endopolygalacturonase is used to hydrolyze pectate to produce pectate oligosaccharides (see, e.g., Iwasaki 1998, abstract); therefore, it is obvious from the teachings of Iwasaki 1998 and Iwasaki 2000 that deactivation of endopolygalacturonase would result stopping the hydrolysis of pectate to produce pectate oligosaccharides. Perez-Martinez was cited to teach the limitation pertaining to the percentage of EDTA, wherein Perez-Martinez teaches using 10% and 20% EDTA within the solution at acidic and alkaline pH (see, e.g., Perez-Martinez, Pectin Extraction). As discussed above, the percentage of EDTA is a result effective variable that can be met as a matter of routine optimization. Applicant has not provided any supportive evidence that the percentage of EDTA is critical to the claimed invention; therefore, it is prima facie obvious that one of ordinary skill in the art would recognize this percentage of EDTA can be met as a matter of routine optimization. Furthermore, one would have been motivated to manipulate and optimize the amount of EDTA because Perez-Martinez teaches the highest pectin yield was observed under alkaline conditions and 20% EDTA (see, e.g., Perez-Martinez, abstract). Kerovuo was cited to teach the limitation pertaining to potassium sorbate, wherein the pectate lyase lyophilized composition contains 0.1% potassium sorbate (see, e.g., Kerovuo, [0097]), wherein the potassium sorbate is used as an additive in the composition for stability (see, e.g., Kerovuo, [0560]). As discussed above, the concentration of potassium sorbate is a result effective variable that can be met as a matter of routine optimization. Applicant has not provided any supportive evidence that the amount of potassium sorbate is critical to the claimed invention; therefore, it is prima facie obvious that one of ordinary skill in the art would recognize this concentration of potassium sorbate can be met as a matter of routine optimization. Furthermore, Kerovuo teaches that potassium sorbate is used as an additive in the composition for stability (see, e.g., Kerovuo, [0560]); therefore, this is motivation for one of ordinary skill in the art to manipulate and optimize the amount of potassium sorbate in order to enhance stability of the composition. Lastly, Applicant merely states that the combination of these references is improper, but does not provide any supportive evidence or examples to support this argument. Additionally, Applicant is arguing against reference individually and one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding Applicant’s argument that Perez-Martinez is non-analogous art (remarks, pages 8-9), it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Perez-Martinez teaches pectin from Opuntia ficus (see, e.g., Perez-Martinez, abstract), and the instantly claimed invention pertains to OGAs from pectin. Furthermore, Applicant states that Perez-Martinez does not teach an enzymatic reaction system that is claimed in the instant application; however, this argument is not persuasive because Perez-Martinez was not used to teach this limitation. Instead Iwasaki 1998 teaches the reaction system, as discussed above (see, e.g., Iwasaki 1998, Apparatus, pg. 263).
Regarding Applicant’s argument that there is no motivation to add potassium sorbate into the claimed OGA preparation (remarks, page 9), this argument is not persuasive because Kerovuo was cited to teach the limitation pertaining to potassium sorbate, wherein the pectate lyase lyophilized composition contains 0.1% potassium sorbate (see, e.g., Kerovuo, [0097]), wherein the potassium sorbate is used as an additive in the composition for stability (see, e.g., Kerovuo, [0560]). Furthermore, Kerovuo teaches addition of the potassium sorbate to the lyophilized composition, which is motivation for one of ordinary skill in the art to add the potassium sorbate to the reaction mixture after thermal inactivation of the enzyme and solidification of the final product, as claimed. Moreover, one of ordinary skill in the art, based on the teachings of Kerovuo, would be motivation to add potassium sorbate to the final composition in order to stabilize the composition (see, e.g., Kerovuo, [0560]).
Regarding Applicant’s argument that Iwasaki 1998 does not disclose or suggest the claimed reaction system (remarks, pages 9-10), this argument is not persuasive for multiple reasons:
First, Iwasaki 1998 teaches “a continuous hydrolysis of pectate was carried out to obtain with high efficiency pectate oligosaccharides with various DPs by an immobilized endo-polygalacturonase in a continuous stirred tank reactor (CSTR)” (see, e.g., Iwasaki 1998, Introduction, pg. 262). Iwasaki 1998 teaches “The CSTR system is made up of a feed tank, reactor tank, pump, receiver, electric weight for balance, and controller for temperature and agitation” (see, e.g., Iwasaki 1998, Apparatus, pg. 263). Additionally, Iwasaki 1998 teaches that the pectin is from citrus pectin (see, e.g., Iwasaki 1998, Materials, pg. 262). Iwasaki 1998 teaches that the pectinolytic enzyme is endo-polygalacturonase from Aspergillus pulverulentus (see, e.g., Iwasaki 1998, Materials, pg. 262). However, the additional instantly claimed limitations, such as the EDTA, potassium sorbate, etc., were taught by Iwasaki 2000, Perez-Martinez, and Kerovuo, as discussed above.
Secondly, Applicant’s argument that the claimed invention incorporates various components within a reaction that yields a stable formulation for at least two years (remarks, page 10); however, this is not part of the instantly claimed invention. The broadest reasonable interpretation of the instantly claimed invention pertains to a method of preparing oligogalacturonides by an enzymatic method in a reactor. Based on the BRI of the claimed invention, the invention does not pertain to increasing stability of the formulation. However, as discussed above, Kerovuo teaches that potassium sorbate is used as an additive in the composition for stability (see, e.g., Kerovuo, [0560]), which one of ordinary skill in the art would understand would increase the stability of the composition.
Regarding Applicant’s argument that there is no reasonable expectation of success (remarks, page 11), this argument is not persuasive Applicant is arguing that the novelty of the claimed invention pertains to enhancing long-term stabilization of a commercial OGA preparation through this reaction system; however, Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. Applicant states that the claimed invention represents more than routine optimization; however, this is not persuasive because Applicant provides no supportive evidence that the result effective variables (i.e., percentages, pH, concentrations, temperatures, etc.) are critical to the claimed invention; therefore, absent any criticality, the instantly claimed invention is prima facie obvious to one of ordinary skill in the art in view of the references cited above. Moreover,
Conclusion
Claims 1 and 4-5 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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