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 .
This office action is formulated as third non-final rejection to analyze the pending double patenting rejection, see analysis below.
Claim Status
Applicant’s amendment of claims 1 submitted on 03/18/2026 is acknowledged. Claims 1-5 are pending and are examined in this Office Action.
Following analysis has been modified since applicant has amended claim 1 to include limitation of a ratio of sucrose to NAA is 3:1.
Claim Rejections - 35 USC § 112 - Indefiniteness
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 and 2-5 dependent thereon 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.
Regarding claim 1, the claim recite step d) which use the step of heating the mixture of step c), wherein the step e) use the culture obtained from the mixture of step c) to cultivate subcultures, therefore it is not clear whether step d) is a required step in the method for cultivating agave cells or whether it recite a separate method that ends in heating the mixture. Furthermore, it is not clear whether subculture of step e) would require the
The following analysis is based on the assumption that claim 1 step e) would depend on step d).
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.
Obvious over Tejavathi et al. and further in view of Qiao et al. Nava et al., Schwartz et al., Iniguez et al., Nielsen et al., Medina et al., Whitton et al.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Tejavathi et al. (Published: 2007, Journal: In Vitro Cell.Dev.Biol.—Plant 43:423–428, DOI 10.1007/s11627-007-9088-8), and further in view of Qiao et al. (Published: 2010, Journal: Appl Biochem Biotechnol 160:613–620, DOI 10.1007/s12010-008-8455-1), and further in view of Nava et al. (Published: 2018, Journal: Journal of Cleaner Production 172: 3713e3720, 3713e3720, http://dx.doi.org/10.1016/j.jclepro.2017.07.134), and further in view of Schwartz et al. (Published: 2003, Journal: Bioprocess International, pages 43-49), and further in view of Iniguez et al. (Published: 2014, Journal: Advances in Chemical Engineering and Science, 2014, 4, 135-142, http://www.scirp.org/journal/aces http://dx.doi.org/10.4236/aces.2014.42016), and further in view of Medina et al. (US Patent Application Pub. No.: US 2014/0154398 A1, Pub. Date: Jun. 5, 2014), further in view of Nielsen et al. (Published: 2007, Journal: Food Microbiology 24:101–105), and Further in view of Whitton et al. (US Patent No .: US 10,465,215 B2, Date of Patent : Nov. 5 , 2019)
Claims are drawn to a method for cultivating agave cells for the production of sugar, adding carbon dioxide, yeast and ferment the composition, remove ethanol, remove salt and dehydrate the filtered concentrate to produce sugar.
Regarding claims 1-2, a method for cultivating agave cells for the production of sugar was known in the art.
Tejavathi et al. teaches callus introduction media including sucrose, naphthalene acetic acid, and water wherein the embryogenic callus was cultured (page 423, Abstract).
Tejavathi et al. teaches the culture media was supplemented with L2 vitamins (page 423, Abstract).
Tejavathi et al. teaches the culture media was adjusted to pH 5.6 (page 424, right first paragraph).
Tejavathi et al. teaches the cultures were incubated at 25±2°C under 16-h photoperiod with illumination by white fluorescent light (page 424, right first paragraph).
Tejavathi et al. teaches subculturing of the embryonic callus formed shoots along with roots wherein young plantlets with roots became separated and healthy plantlets were obtained (Figure 1, page 425, left paragraph 2).
Tejavathi et al. teaches increased sucrose over the different concentrations NAA would increase the number of somatic embryos see page 424, Table 1. Tejavathi teaches in other species of agave for example in A. Victoria-reginae the increased concentration of sucrose was also found to increase somatic embryos and in F. tartatucum the somatic embryogenesis was effect when sucrose was 6% w/v higher than applicant’s 3% sucrose as showed in Spec, paragraph 0018 (Tejavathi, page 427, left first paragraph).
Furthermore, Whitton et al. teaches ratio culture media comprising 3% sucrose and 1% NAA and vitamin solution for culture of wheat plant cell (col. 23, lines 17-30). Whitton et al. teaches optimization of the cell suspension culture using pH buffering by using citric acid wherein the optimum pH for separation of oil was at 4.5 (col.25, lines 45-66).
Therefore ratio of sucrose to NAA that would increase the somatic embryo would have been empirically determined in species of Agaves 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 sucrose and NAA in particular ration (Tejavathi et al., page 424, Table 1) for cultivating agave cells, therefore, determining the specific sucrose: NAA ratio is a routine experimentation.
Tejavathi et al. does not teach adding citric acid to obtain PH of between 3.5-4.5 and adding carbon dioxide in fermentation.
Nielsen et al. teaches citric acid has been utilized for acidulant (page 101, left paragraph 1) to lower PH thereby to kill or inhibit growth of spoilage micro-organisms, wherein in the lower PH value in the range 3-4.5 would increase the growth and metabolism of anaerobic S. cerevisiae and Z. bailii cultures and fermentation process (i.e. ethanol) wherein increase in the growth inhibition of S. cerevisiae was found in higher PH of 4.5 (page 103, right second to last paragraph, Tables 1 and 2). Therefore, maintaining the PH of 3.5 by adding citric acid in subcultures would have been obvious for fermentation of the agave cells leading to regulation of pH, improve microbial stability and making the product less susceptible to the growth of antimicrobial agent for undesired microorganisms.
Furthermore, Qiao et al. teaches increasing carbon dioxide in culture have increased the production of natural sugar trehalose yields in fermentation process (pages 616 and 617, second to last paragraph and Table 1 and Figure 2). Therefore, it would have been obvious to use carbon dioxide in fermentation process using yeast for better fermentation process.
Tejavathi et al., Nielson et al. and Qiao et al. does not teach removing ethanol and remove salts from the sugar extract.
Nava et al. teaches process of distillation to separate alcohol which generate liquid waste as vinasses (page 3714, right paragraph 3) and bagasse (page 3714, left paragraph 3, see Figure 4 below).
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Nava et al. teaches the agave bagasse contains up to 5% reducing sugar and vinasses contains 2 % reducing sugar (page 3716, Table 1 and Table 2). Therefore, it would have been obvious to utilize the residues after separation of ethanol for production of sugar.
Iniguez et al. teaches extraction of sugar from agave bagasse that contains various amount of reducing sugars from 5-20% and fructose 3-7% and Glucose 0.4-0.5%. (page 136, see Table 3 and Table 4 below).
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Nava et al. teaches Tequila waste comprise dissolve salt content (page 3719, left second paragraph).
Schwartz et al. teaches removing and lowering concentration from solution containing proteins, peptides, nucleic acid and other biomolecules (page 43, left paragraph 1) using the molecular weight cut-off technique using defiltration (page 43, middle paragraph 1).
Medina et al. teaches evaporation (i.e. dehydration) of moisture in syrup for crystallization of the sugar (paragraphs 0034-0038)
Thus, it would have been obvious from teaching, suggestion, or motivation in the Tejavathi et al. to culture and subculture the agave cells including sucrose, naphthalene acetic acid, and water, supplemented by a vitamin at PH 5.6 and heat the mixture. Furthermore, from teaching of Nielson et al. to add citric acid to obtain PH 3.5 in subcultures and furthermore the method would include adding carbon dioxide and yeast taught by Qiao et al. that showed to have better fermentation, that would have led one of ordinary skill to combine the Tejavathi et al teachings to Nielson et al. and Qiao et al. Furthermore, remove ethanol and filter sugar extract to remove salts and dehydrate the filtered sugar concentrate to produce sugar as taught by Nava et al., Schwartz et al., Medina et al. This would have led to the claimed invention of method for cultivating agave cells for the production of sugar.
Regarding claim 3, Medina et al. teaches converting sugar to syrup would require making an aqueous solution of the extracted sugar (Medina et al., paragraph 0012).
Regarding claim 4, converting agave syrup to crystal sugar is known in the art. Medina et al. teaches producing a crystallized Sweetener from agave syrup (page 4, claim 1, paragraph 0042).
Medina et al. teaches Crystal Sweeteners made from agave syrup have a low glycemic index (paragraphs 0003, and 0043).
Therefore, someone skilled in the art would produce crystal sugar that would be easily used for individual serving of for example food beverages and would also healthy for having low glycemic index.
Regarding claim 5, Iniguez et al. teaches extraction of sugar from agave bagasse that contains various amount of reducing sugars from 5-20% (i.e. at least 6%) (page 136, Table 3 and Table 4, see table above).
Response to Argument
Applicant's arguments filed 03/18/2026 have been fully considered but they are not persuasive.
Applicant argues Tejavathi concerns an attempt to mass product an Indian ornamental plant, and has nothing to do with the Mexican variety of the agave plant. Applicant argues the objective of mass producing an ornamental plant is far different from the harvesting on a commercial scale sugar from a lab grown plant. Applicant argues the sucrose to NAA ratio for Tejavathi is also less than half of the claimed invention, which further argues that the steps are not obvious. Applicant argues Tejavathi fails to teach the claimed step of taking the callus grown through incubation into an accelerator media - there is simply no such step taught by Tejavathi and the Office Action does not address this omission (Response to Rejection, page 4, paragraph 2).
Applicant argues the office action also cites Neilsen for the use of citric acid, citing the use of citric acid in S. Cerevisiae and Z. bailii cultures. Applicant argues this is fundamentally flawed for two reasons. Applicant argues first, there is no teaching in Tejavathi for reducing the pH at all, so where is the rationale for adding this step in the first place? The objectives of Tejavathi do not appear to be met by this step and there is nothing that suggests this will be fruitful. Applicant argues second, the Office Action has not established that Agave cells and S. Cerevisiae/Z. bailii cultures react in the same way to citric acid. Applicant argues absent this linking, or any teaching that would suggest to a person of ordinary skill in the art (without the benefit of Applicant's disclosure) that it would be obvious to treat Tejavathi's ornamental plant leaves with Neilsen's citric acid is not found in the record. Applicant respectfully requests that some showing be made that a person of ordinary skill in the art would know that S. Cerevisiae and agave would clearly and obviously be treated in the exact same manner as proposed by the Office Action (Response to Rejection, page 4, paragraph 2).
Applicant argues Office Action also cites Nava for the proposition that Neilsen and Qiao would obviously be modified by the teachings of Nava to remove ethanol, but none of those references discuss why this would be the case. Applicant argues there is nothing in Neilsen or Qiao about ethanol build up, or why a person of ordinary skill would introduce the teachings of Nava ( which deals with waste). Applicant argues unless the person of ordinary skill in the art was using Applicant's disclosure as a road map, it cannot be said that the addition of Nava' s step of removing ethanol is an obvious modification of Tejavathi/Neilsen/Qiao. Applicant argues the rejection of Claim 1 for this reason is properly withdrawn (Response to Rejection, pages 4 and 5, last and first paragraph).
Applicant argues the office action states initially that "a method for cultivating agave cells for the production of sugar was known in the art." [Office Action, page 4] Applicant respectfully disagrees. Applicant argues none of the references cited by the Office Action teach, or even suggest, this the cultivation of sugars from lab grown agave cells. Applicant argues Rejavathi teaches the propagation of agave plants, but there is zero mention of harvesting sugar. Applicant argues a person of ordinary skill in the art would take from the Tejavathi reference that agave embryos can be grown from agave plants. Applicant argues there is nothing in Tejavathi that teaches that sugars can be harvested from suspended cells in vitro. Applicant argues the identification of every step in a claimed method does not, pro se, mean the method is not a patentable invention. Applicant argues particularly when the Office Action relies on seven (7) references to teach the eight (8) steps of Claim 1 (Response to Rejection, page 5, second paragraph).
Applicant argues the Office Action relies on Nielson and Qiao for the position that sugars may be grown from cells, but those references teach that yeast cells are the source. Applicant argues conversely, the present invention uses plant cells, and more particularly agave plant cells, which is not found anywhere in the literature. Applicant argue to obtain the sugars obtained in the present invention would require a genetic modification to the yeast cells, which is not taught nor suggested by Nielsen or Qiao. Applicant argues the OA does not explain this process of genetic modification, and assumes yeast cells and agave cells react similarly. Applicant argues since this is definitely not the case, the reliance of the Office Action on Nielsen and Qiao is misplaced.
Applicant argues Nava and Iniguez are cited for the extraction of sugar from plants, but they discuss the removal of excess sugar from leaves and plant waste (bagasse ), and are silent as to how one would extract sugar from the cells of the plants or cell cultures. Applicant argues as stated above, there is no evidence in the record that any of the references teach the basic object of the invention to extract sugars from cells of agave grown in a lab. Applicant argues thus any attempt to back fill the prior art into Claim 1 fails the basic test of obviousness, that such a method was in the prior art (and not merely possible with prior art knowledge).
Applicant's arguments have been fully considered but they are not persuasive since:
Regarding argument on objective of the agave of Tejavathi are different from applicant’s was not found persuasive since Tejavathi teaches the method of cultivating agave cells. The sucrose to NAA ratio although low in Tejavathi it would be a routine optimization to find the specific 3:1 ratio of the sucrose: NAA, see analysis above. Furthermore, Tejavathi et al. teaches increased sucrose over the different concentrations NAA would increase the number of somatic embryos see page 424, Table 1. Tejavathi teaches in other species of agave i.e. A. Victoria-reginae the increased concentration of sucrose was also found to increase somatic embryos (Tejavathi, page 427, left first paragraph).
Regarding argument on Tejavathi fails to teach the claimed step of taking the callus grown through incubation into an accelerator media, the argument was not found persuasive since Tejavathi et al. teaches the cultures were incubated at 25±2°C under 16-h photoperiod with illumination by white fluorescent light (page 424, right first paragraph). Therefore such media would be the accelerator of growth.
Regarding argument on there is no teaching in Tejavathi for reducing the pH at all, so where is the rationale for adding this step in the first place, the argument was not found persuasive since maintaining the PH of 3.5 by adding citric acid in subcultures would have been obvious for fermentation of the agave cells wherein Nielsen et al. teaches citric acid has been utilized for acidulant to lower PH to 3-4.5 that would increase the growth and metabolism of anaerobic S. cerevisiae and Z. bailii cultures and fermentation process wherein increase in the growth inhibition of S. cerevisiae was found in higher PH (page 103, right second to last paragraph). Applicant’s claim 1 step (f) has step of fermentation using yeast. Therefore someone skilled in the art would use Citric acid to maintain the lower PH to improve fermentation process as taught by Tejavathi.
Regarding argument on Nava for the proposition that Neilsen and Qiao would obviously be modified by the teachings of Nava to remove ethanol, but none of those references discuss why this would be the case Nava et al. is clear that a sugar can be extracted from the fermentation byproduct of agave, therefore someone skilled in the art looking for extracting sugar would use method of Neilsen to improve the fermentation and method of Qiao et al. including increasing carbon dioxide in culture that would increase the production of natural sugar trehalose yields in fermentation process (pages 616 and 617, second to last paragraph and Table 1 and Figure 2).
Regarding argument Tejavathi does not teach extracting sugar was not found persuasive since Nava et al. teaches sugar can be extracted as byproduct in the Tequila factory (page 3717, right paragraphs 1 and 2). Therefore someone skilled in the art to extract the sugar from byproduct would utilized the known and efficient method taught by Tejavathi/Neilsen/Qiao for cultivating the agave and efficient fermentation.
Regarding argument on to obtain the sugars obtained in the present invention would require a genetic modification to the yeast cells, the argument was not found persuasive since there is no such limitation in any of the claims. The claim does not recite specific modified yeast or strain useful for efficient fermentation or extraction of sugar from agar. Therefore the argument is moot point. Furthermore, applicant claim 1 (f) recite addition of yeast for fermentation. Therefore the ethanol production would have been facilitated by added yeast or the yeast originally present in the agave plant naturally.
Regarding argument on Nava and Iniguez they discuss the removal of excess sugar from leaves and plant waste (bagasse ), Nava et al. teaches about the byproduct of Tequila (i.e. ethanol) production an separation of the biproduct which encompass the sugar, Therefore applicant’s invention relates to cultivation, fermentation and separation of ethanol and sugar which is taught by Tejavathi/Neilsen/Qiao/Nava et al. etc.
Regarding argument on Tejavathi that there is nothing in Tejavathi about extracting sugar, and asserting that it is only growing the plants. The argument were not found persuasive since Tejavathi et al. teaches callus introduction media including sucrose, naphthalene acetic acid, and water wherein the embryogenic callus was cultured wherein the culture media was supplemented with L2 vitamins in PH 5.6 (page 423, Abstract). Therefore Tejavathi et al. clearly showed the method for cultivating agave cells. Nava teaches process of distillation to separate alcohol which generate liquid waste as vinasses (page 3714, right paragraph 3) and bagasse (page 3714, left paragraph 3, see Figure 4 below) wherein the agave bagasse contains up to 5% reducing sugar and vinasses contains 2 % reducing sugar (page 3716, Table 1 and Table 2). Furthermore, Iniguez et al. teaches extraction of sugar from agave bagasse that contains various amount of reducing sugars. Therefore, the extracting of sugar would have been obvious.
Regarding argument on specific agave plant and yeast culture is not described in the Qiao, the argument is moot point since the examining claims does not recite specific agave plant or any specific yeast culture. Regarding argument for example that there is nothing that teaches sugar can be extracted from Tejavathi's agave vera-cruz, for example Srinivasan et al. (Published: 1953, Journal: Biochem J, 55(2):286–289. doi: 10.1042/bj0550286) taches different kinds of sugar or carbohydrates including glucose, fructose etc. are found in the agave vera-cruz and teaches method of isolation of polyfructosans (page 287, Table 2, left paragraph 2).
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Regarding argument on Qiao et al. teaches increasing carbon dioxide in culture have increased the production of natural sugar trehalose yields in fermentation process (pages 616 and 617, second to last paragraph and Table 1 and Figure 2). Therefore, it would have been obvious to add carbon dioxide in the method for production of sugar.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law.
Furthermore, where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because the test for obviousness is what the combined teachings of the references would have suggested to a person having ordinary skill in the art (PHOSITA).”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12618029 B2 (Hereafter referenced as Patent‘029) in view of Tejavathi et al., Whitton et al., Nava et al., Iniguez et al. and Schwartz et al., Madina et al.
Regarding claim 1, Patent‘029 claims 1 recites a method for cultivating agave cells or sugar cells that includes preparing a callus introduction media including sugar, NAA and water, heating the mixture, using mixture to cultivate subcultures supplemented by an acid and adding carbon dioxide and yeast.
Patent‘029 does not teach using vitamin in culture media and incubating and illumination with light.
Tejavathi et al. teaches the culture media was supplemented with L2 vitamins (page 423, Abstract).
Tejavathi et al. teaches the culture media was adjusted to pH 5.6 (page 424, right first paragraph).
Tejavathi et al. teaches the cultures were incubated at 25±2°C under 16-h photoperiod with illumination by white fluorescent light (page 424, right first paragraph).
Tejavathi et al. teaches subculturing of the embryonic callus formed shoots along with roots wherein young plantlets with roots became separated and healthy plantlets were obtained (Figure 1, page 425, left paragraph 2).
Tejavathi et al. teaches increased sucrose over the different concentrations NAA would increase the number of somatic embryos see page 424, Table 1. Tejavathi teaches in other species of agave for example in A. Victoria-reginae the increased concentration of sucrose was also found to increase somatic embryos and in F. tartatucum the somatic embryogenesis was effect when sucrose was 6% w/v higher than applicant’s 3% sucrose as showed in Spec, paragraph 0018 (Tejavathi, page 427, left first paragraph).
Furthermore, Whitton et al. teaches ratio culture media comprising 3% sucrose and 1% NAA and vitamin solution for culture of wheat plant cell (col. 23, lines 17-30). Whitton et al. teaches optimization of the cell suspension culture using pH buffering by using citric acid wherein the optimum pH for separation of oil was at 4.5 (col.25, lines 45-66).
Therefore ratio of sucrose to NAA that would increase the somatic embryo would have been empirically determined in species of Agaves 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 sucrose and NAA in particular ration (Tejavathi et al., page 424, Table 1) for cultivating agave cells, therefore, determining the specific sucrose: NAA ratio is a routine experimentation.
Tejavathi et al. does not teach adding citric acid to obtain PH of between 3.5-4.5 and adding carbon dioxide in fermentation.
Nielsen et al. teaches citric acid has been utilized for acidulant (page 101, left paragraph 1) to lower PH thereby to kill or inhibit growth of spoilage micro-organisms, wherein in the lower PH value in the range 3-4.5 would increase the growth and metabolism of anaerobic S. cerevisiae and Z. bailii cultures and fermentation process (i.e. ethanol) wherein increase in the growth inhibition of S. cerevisiae was found in higher PH of 4.5 (page 103, right second to last paragraph, Tables 1 and 2). Therefore, maintaining the PH of 3.5 by adding citric acid in subcultures would have been obvious for fermentation of the agave cells leading to regulation of pH, improve microbial stability and making the product less susceptible to the growth of antimicrobial agent for undesired microorganisms.
Patent‘029 does not teach using citric acid in the media and does not teach about they have cultivated agave cells for production of sugar.
Nielsen et al. teaches citric acid has been utilized for acidulant (page 101, left paragraph 1) to lower PH thereby to kill or inhibit growth of spoilage micro-organisms, wherein in the lower PH value in the range 3-4.5 would increase the growth and metabolism of anaerobic S. cerevisiae and Z. bailii cultures and fermentation process (i.e. ethanol) wherein increase in the growth inhibition of S. cerevisiae was found in higher PH of 4.5 (page 103, right second to last paragraph, Tables 1 and 2). Therefore, maintaining the PH of 3.5 by adding citric acid in subcultures would have been obvious for fermentation of the agave cells leading to regulation of pH, improve microbial stability and making the product less susceptible to the growth of antimicrobial agent for undesired microorganisms.
Tejavathi et al., Nielson et al. and Qiao et al. does not teach removing ethanol and removing salts from the sugar extract.
Nava et al. teaches process of distillation to separate alcohol which generate liquid waste as vinasses (page 3714, right paragraph 3) and bagasse (page 3714, left paragraph 3, see Figure 4 below).
Nava et al. teaches the agave bagasse contains up to 5% reducing sugar and vinasses contains 2 % reducing sugar (page 3716, Table 1 and Table 2). Therefore, it would have been obvious to utilize the residues after separation of ethanol for production of sugar.
Iniguez et al. teaches extraction of sugar from agave bagasse that contains various amount of reducing sugars from 5-20% and fructose 3-7% and Glucose 0.4-0.5%. (page 136, see Table 3 and Table 4 below).
Nava et al. teaches Tequila waste comprise dissolve salt content (page 3719, left second paragraph).
Schwartz et al. teaches removing and lowering concentration from solution containing proteins, peptides, nucleic acid and other biomolecules (page 43, left paragraph 1) using the molecular weight cut-off technique using defiltration (page 43, middle paragraph 1).
Medina et al. teaches evaporation (i.e. dehydration) of moisture in syrup for crystallization of the sugar (paragraphs 0034-0038)
Thus, it would have been obvious from teaching, suggestion, or motivation in the Patent‘492 to culture and subculture the agave cells including sucrose, naphthalene acetic acid, and water, and suggestion from Tejavathi et al. to supplement the media by a vitamin at PH 5.6 and heat the mixture. Whitton et al. teaches media comprising 3:1 ration of sugar:NAA. Furthermore, from teaching of Nielson et al. to add citric acid to obtain PH 3.5 in subcultures that would improve fermentation process and reduce the unwanted yeast growth, that would have led one of ordinary skill to combine the Patent‘492’s teachings to Nielson et al. Furthermore, remove ethanol and filter sugar extract to remove salts and dehydrate the filtered sugar concentrate to produce sugar as taught by Nava et al., Schwartz et al., Medina et al. This would have led to the claimed invention of method for cultivating agave cells for the production of sugar.
Regarding claim 3, Medina et al. teaches converting sugar to syrup would require making an aqueous solution of the extracted sugar (Medina et al., paragraph 0012).
Regarding claim 4, converting agave syrup to crystal sugar is known in the art. Medina et al. teaches producing a crystallized Sweetener from agave syrup (page 4, claim 1, paragraph 0042).
Medina et al. teaches Crystal Sweeteners made from agave syrup have a low glycemic index (paragraphs 0003, and 0043).
Therefore, someone skilled in the art would produce crystal sugar that would be easily used for individual serving of for example food beverages and would also healthy for having low glycemic index.
Regarding claim 5, Patent‘029 claim 11 teach the total sugar in dry weight is less than six percentage.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 9 and 10 of U.S. Patent No. 11895962 (Hereafter referenced as Patent ‘962) in view of Nava et al., Iniguez et al. and Schwartz et al., Madina et al.
Regarding claim 1, Patent‘962 claim 1 recites a method for cultivating agave cells or sugar cells that includes preparing a callus introduction media including sugar, NAA and water, vitamin stock solution, heating the mixture, using mixture to cultivate subcultures supplemented by a citric acid and adding carbon dioxide and yeast.
Patent‘962 claim 3 recites the media has sugar:NAA of 3:1.
Patent‘962 claim 9 recites introducing light to the accelerator media.
Patent‘962 does not teach using citric acid in the media and does not teach about they have cultivated agave cells for production of sugar.
Nielsen et al. teaches citric acid has been utilized for acidulant (page 101, left paragraph 1) to lower PH thereby to kill or inhibit growth of spoilage micro-organisms, wherein in the lower PH value in the range 3-4.5 would increase the growth and metabolism of anaerobic S. cerevisiae and Z. bailii cultures and fermentation process (i.e. ethanol) wherein increase in the growth inhibition of S. cerevisiae was found in higher PH of 4.5 (page 103, right second to last paragraph, Tables 1 and 2). Therefore, maintaining the PH of 3.5 by adding citric acid in subcultures would have been obvious for fermentation of the agave cells leading to regulation of pH, improve microbial stability and making the product less susceptible to the growth of antimicrobial agent for undesired microorganisms.
Patent‘962 and Nielson et al. does not teach removing ethanol and removing salts from the sugar extract.
Nava et al. teaches process of distillation to separate alcohol which generate liquid waste as vinasses (page 3714, right paragraph 3) and bagasse (page 3714, left paragraph 3, see Figure 4 below).
Nava et al. teaches the agave bagasse contains up to 5% reducing sugar and vinasses contains 2 % reducing sugar (page 3716, Table 1 and Table 2). Therefore, it would have been obvious to utilize the residues after separation of ethanol for production of sugar.
Iniguez et al. teaches extraction of sugar from agave bagasse that contains various amount of reducing sugars from 5-20% and fructose 3-7% and Glucose 0.4-0.5%. (page 136, see Table 3 and Table 4 below).
Nava et al. teaches Tequila waste comprise dissolve salt content (page 3719, left second paragraph).
Schwartz et al. teaches removing and lowering concentration from solution containing proteins, peptides, nucleic acid and other biomolecules (page 43, left paragraph 1) using the molecular weight cut-off technique using defiltration (page 43, middle paragraph 1).
Medina et al. teaches evaporation (i.e. dehydration) of moisture in syrup for crystallization of the sugar (paragraphs 0034-0038)
Thus, it would have been obvious from teaching, suggestion, or motivation in the Patent‘962 to culture and subculture the agave cells including sucrose, naphthalene acetic acid, and water, supplemented by a vitamin at PH 5.6 and heat the mixture. Furthermore, from teaching of Nielson et al. to add citric acid to obtain PH 3.5 in subcultures that would improve fermentation process and reduce the unwanted yeast growth, that would have led one of ordinary skill to combine the Patent‘962’s teachings to Nielson et al. Furthermore, remove ethanol and filter sugar extract to remove salts and dehydrate the filtered sugar concentrate to produce sugar as taught by Nava et al., Schwartz et al., Medina et al. This would have led to the claimed invention of method for cultivating agave cells for the production of sugar.
Regarding claim 3, Medina et al. teaches converting sugar to syrup would require making an aqueous solution of the extracted sugar (Medina et al., paragraph 0012).
Regarding claim 4, converting agave syrup to crystal sugar is known in the art. Medina et al. teaches producing a crystallized Sweetener from agave syrup (page 4, claim 1, paragraph 0042).
Medina et al. teaches Crystal Sweeteners made from agave syrup have a low glycemic index (paragraphs 0003, and 0043).
Therefore, someone skilled in the art would produce crystal sugar that would be easily used for individual serving of for example food beverages and would also healthy for having low glycemic index.
Regarding claim 5, Patent‘962 claim 10 teach the total sugar in dry weight is less than six percentage.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7, 10-11 of copending Application No. 19182557 (Hereafter referenced as Application‘557) in view of Nava et al., Iniguez et al. and Schwartz et al., Madina et al.
Regarding claim 1, Application‘557 claims 1 recites a method for cultivating agave cells that includes preparing a callus introduction media including sugar, NAA and water, then heating the mixture, using mixture to cultivate subcultures supplemented by an acid and adding carbon dioxide and yeast.
Application‘557 claim 2 recites media forms fructans.
Application‘557 claim 3 recites the media has sugar:NAA of 3:1.
Application‘557 claim 7 recites the media comprise vitamin stock solution.
Application‘557 claim 10 recites introducing light to the accelerator media.
Application‘557 does not specifically teach using citric acid in the media and does not teach about they have cultivated agave cells for production of sugar.
Nielsen et al. teaches citric acid has been utilized for acidulant (page 101, left paragraph 1) to lower PH thereby to kill or inhibit growth of spoilage micro-organisms, wherein in the lower PH value in the range 3-4.5 would increase the growth and metabolism of anaerobic S. cerevisiae and Z. bailii cultures and fermentation process (i.e. ethanol) wherein increase in the growth inhibition of S. cerevisiae was found in higher PH of 4.5 (page 103, right second to last paragraph, Tables 1 and 2). Therefore, maintaining the PH of 3.5 by adding citric acid in subcultures would have been obvious for fermentation of the agave cells leading to regulation of pH, improve microbial stability and making the product less susceptible to the growth of antimicrobial agent for undesired microorganisms.
Tejavathi et al., Nielson et al. and Qiao et al. does not teach removing ethanol and removing salts from the sugar extract.
Nava et al. teaches process of distillation to separate alcohol which generate liquid waste as vinasses (page 3714, right paragraph 3) and bagasse (page 3714, left paragraph 3, see Figure 4 below).
Nava et al. teaches the agave bagasse contains up to 5% reducing sugar and vinasses contains 2 % reducing sugar (page 3716, Table 1 and Table 2). Therefore, it would have been obvious to utilize the residues after separation of ethanol for production of sugar.
Iniguez et al. teaches extraction of sugar from agave bagasse that contains various amount of reducing sugars from 5-20% and fructose 3-7% and Glucose 0.4-0.5%. (page 136, see Table 3 and Table 4 below).
Nava et al. teaches Tequila waste comprise dissolve salt content (page 3719, left second paragraph).
Schwartz et al. teaches removing and lowering concentration from solution containing proteins, peptides, nucleic acid and other biomolecules (page 43, left paragraph 1) using the molecular weight cut-off technique using defiltration (page 43, middle paragraph 1).
Medina et al. teaches evaporation (i.e. dehydration) of moisture in syrup for crystallization of the sugar (paragraphs 0034-0038)
Thus, it would have been obvious from teaching, suggestion, or motivation in the Application‘557 to culture and subculture the agave cells including sucrose, naphthalene acetic acid, and water, supplemented by a vitamin at PH 5.6 and heat the mixture. Furthermore, from teaching of Nielson et al. to add citric acid to obtain PH 3.5 in subcultures that would improve fermentation process and reduce the unwanted yeast growth, that would have led one of ordinary skill to combine the Application ‘557’s teachings to Nielson et al. Furthermore, remove ethanol and filter sugar extract to remove salts and dehydrate the filtered sugar concentrate to produce sugar as taught by Nava et al., Schwartz et al., Medina et al. This would have led to the claimed invention of method for cultivating agave cells for the production of sugar.
Regarding claim 3, Medina et al. teaches converting sugar to syrup would require making an aqueous solution of the extracted sugar (Medina et al., paragraph 0012).
Regarding claim 4, converting agave syrup to crystal sugar is known in the art. Medina et al. teaches producing a crystallized Sweetener from agave syrup (page 4, claim 1, paragraph 0042).
Medina et al. teaches Crystal Sweeteners made from agave syrup have a low glycemic index (paragraphs 0003, and 0043).
Therefore, someone skilled in the art would produce crystal sugar that would be easily used for individual serving of for example food beverages and would also healthy for having low glycemic index.
Regarding claim 5, Application‘557 claim 11 teach the total sugar in dry weight is less than six percentage.
This is a provisional nonstatutory double patenting rejection.
Summary
No claim is allowed.
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/SANTOSH SHARMA/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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