DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 1/12/2026 have been received and entered into the case. Claims 17-19 and 28 have been canceled. Claims 1-16, 20-27 and 29-39 are pending, Claims 24, 34-35 and 39 have been withdrawn, and Claims 1-16, 20-23, 25-27, 29-33, and 36-38 have been considered on the merits, insofar as they read on the elected species of Docosahexaenoic acid (DHA), the genus Schizochytrium, beta-glucanase, and alkali metal salts. All arguments have been fully considered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
Claims 1-16, 20-23, 25-27, 29-33, and 36-38 are rejected under 35 U.S.C. 103 as being unpatentable over Triplett et al (US 2016/0319217 A1; 11/3/2016. Cited on IDS) in view of Schaap et al (US 2017/0081684 A1; 3/23/2017.).
The instant claims recite a process for obtaining a lipid from a composition comprising microbial cells, the process comprising: (a) treating the composition comprising the microbial cells by heating the composition to a temperature of about 60°C to about 95°C at a pH of about 9 to about 11 under agitation for a period of time from about 1 hour to about 6 hours; (b) separating the treated microbial cells into a light phase consisting essentially of a concentrated microbial cell composition and a heavy phase consisting essentially of fermentation medium and aqueous material; (c) adjusting the pH of the concentrated microbial cell composition to a pH of about 10 to about 12 by adding a base and maintaining the pH of about 10 to about 12 for at least 1 hour; (d) adjusting the pH of the composition of (c) to a pH of about 3 to about 6 by adding an acid and maintaining the pH of about 3 to about 6 for at least 0.5 hours; (e) repeating steps (c) and (d) until the composition is sufficiently demulsified; (f) separating the lipid from a demulsified lysed cell composition; and (g) recovering the lipid.
Triplett teaches a process for obtaining a microbial oil (a lipid) from microbial cells, the process comprising: lysing the cells comprising the microbial oil to form a lysed cell composition, demulsifying the lysed cell composition, separating the oil from the demulsified lysed cell composition, and recovering the oil (para 0010, 0012). The process comprises heating prior to, during, or after lysing the cells, e.g., from about 60℃ to about 90℃, about 70℃ to about 90℃, about 80℃ to about 90℃ (para 0087, 0089), for a sufficient period of time (para 0088), e.g., 1 hour (para 0114). The process comprises agitating prior to or during lysing of the cells (para 0057-0058), e.g., for 2 hours (para 0114), 8 hours (para 0119), a few hours (para 0115). The process comprises separating the lysed cell composition into different phases including an oil phase, an aqueous phase, and a solid phase (para 0051). The process comprises raising the pH to 8 or above (para 0014, 0042) by adding a base (para 0013, 0043), the pH is from 10 to 12 (para 0045, 0083). The process comprises lowering the pH to 6.5 or less (para 0016, 0042) by adding an acid, the pH is from about 3 to about 6 (para 0047, 0070). Chemical treatment includes raising the pH of the cells, lowering the pH of the cells, and combinations thereof (para 0042). The process comprises adding at least one enzyme (para 0015, 0049), the enzymes suitable for forming a demulsified lysed cell composition include beta-glucanase (para 0067). The process comprises adding a salt in an amount of from about 0.05% to about 20% by weight (para 0086). The process comprises lysing microbial cells mechanically (para 0034). The cells are unwashed (para 0036, 0114), the cells are contained in a fermentation broth (para 0036, 0110). The process comprises centrifuging the demulsified lysed cell composition (para 0096). The pH is raised or lowered (para 0014, 0016, 0042), e.g., 7 to 9 (para 0045), 7 to 8 (para 0083). The oil comprises at least 30% by weight docosahexaenoic acid (DHA, an omega-3 fatty acid, a polyunsaturated fatty acid) (para 0102). The microbial cells are from microalgae of the order Thraustochytriales, the genera Schizochytrium (para 0030, 0033). The lysed cell composition comprises liquid, cell debris, and microbial oil (para 0050). The process does not utilize an organic solvent to obtain, separate, or otherwise recover a microbial oil from the microbial cells (para 0095). The enzymes include beta-glucanase (para 0067), in an amount of from about 0.05% to about 10% by weight (para 0068). The salt is an alkali metal salt (para 0084). The microbial oil obtained and/or recovered is a crude oil, the oil is a refined oil (para 0109). The oil has an anisidine value of less than about 20 (para 0103). The oil has a phosphorus content of 100 ppm or less (para 0105). The oil has a peroxide value of less than about 5 meq/kg (para 0104).
Triplett does not teach the time period for raising and lowering the pH of the microbial cells (claim 1(c)-(d)), step (d) follows step (c), and repeating steps (c) and (d) until the composition is sufficiently demulsified (claim 1(e)).
However, Triplett does teach the process for obtaining a microbial oil (a lipid) from microbial cells demulsify an emulsified lysed cell composition, allowing the microbial oil to be separated from the lysed cell composition (para 0051). Triplett does teach the process comprising demulsifying the lysed cell composition comprises raising the pH of the lysed cell composition to 8 or above to form a demulsified lysed cell composition (para 0014), and demulsifying the lysed cell composition comprises lowering the pH of the lysed cell composition to 6.5 or less to form a demulsified lysed cell composition (para 0016). Triplett does teach chemical treatment includes raising the pH of the cells, lowering the pH of the cells, and combinations thereof (para 0042).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to repeat raising and lowering the pH of microbial cells until the composition is sufficiently demulsified, since Triplett discloses that demulsify an emulsified lysed cell composition allows microbial oil to be separated from the lysed cell composition, and demulsifying the lysed cell composition comprises raising the pH of the cells, lowering the pH of the cells, and combinations thereof. In other words, one skill in the art would repeat raising and lowering the pH of microbial cells until a lysed cell composition is sufficiently demulsified, therefore, allow microbial oil to be separated from the lysed cell composition. In addition, Triplett discloses raising and lowering the pH of microbial cells for the same purpose. Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to arranging the steps as a matter of routine experimentation, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells. Finally, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the time period for raising and lowering the pH of microbial cells, since Triplett discloses a process for obtaining a microbial oil (a lipid) from microbial cells comprises raising and lowering the pH of the microbial cells. In other words, raising and lowering the pH of the microbial cells is routinely practiced in the art of obtaining a microbial oil (a lipid) from microbial cells. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to optimize the time period for raising and lowering the pH of microbial cells, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells.
Triplett does not teach the claimed sequence of steps (claims 1-3 and 12-13), and the composition is subjected to one or more cycles of temperature shock (claims 5-6).
However, Triplett does teach the process for obtaining a lipid from microbial cells comprises heating microbial cells, separating the microbial cells into a light phase and a heavy phase, raising and lowering the pH of the microbial cells, separating the lipid from a demulsified lysed cell composition, and recovering the lipid, wherein heating temperature is from about 60℃ to about 90℃, about 70℃ to about 90℃, about 80℃ to about 90℃ (para 0087, 0089), for a sufficient period of time (para 0088), and pH is raised from 10 to 12 (para 0045, 0083) and lowered from about 3 to about 6 (para 0047, 0070). Schaap teaches a pasteurization process for microbial cells and microbial oil (Title), comprising heating the microbial cells to a temperature above 60℃, the temperature may rise until a temperature of from 70℃ to 90℃ (para 0023), holding the microbial cells at a desired temperature, suitably from 70℃ to 85℃ (para 0029), and cooling the microbial cells to a temperature below 30℃ (para 0037). Table 2 demonstrates the profile of temperature vs. time, wherein pasteurization for only 1 hour at 70℃ give a peroxide value (POV) of 2.2, and POV of 1.2 at 85℃ (para 0112). Schaap teaches the pasteurization process comprises a heating stage, a plateau stage, and a cooling stage improves the quality of microbial oil obtained from microbial cells, and requires less energy (para 0009, 0027).
Triplett does teach each and every step of the claims for the same purpose and therefore recognized result effective variables. Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to arranging the steps as a matter of routine experimentation. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate one or more cycles of temperature shock, since Triplett and Schaap both disclose a process for obtaining a lipid from microbial cells comprises pasteurization, physical treatment and chemical treatment, wherein physical treatment includes heating microbial cells at various temperatures, and chemical treatment includes raising and lowering the pH of microbial cells, and Schaap discloses heating and cooling microbial cells more efficiently provide a better quality microbial oil. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to arrange method steps and to incorporate one or more cycles of temperature shock, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells.
Triplett does not teach the claimed percentage of lysed cells (claim 8).
However, Triplett does teach the process comprises lysing microbial cells mechanically.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to mechanically disrupting microbial cells to achieve a desired result, since lysing microbial cells mechanically is routinely practiced in the art of obtaining a microbial oil (a lipid) from microbial cells, as evidenced by Triplett. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to mechanically disrupting microbial cells to achieve a desired result, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16, 20-23, 25-27, 29-33, and 36-38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10, 13-18, 20-21, 24-26, 28-30, 32-38, and 41 of U.S. Patent No 11,124,736 (referred to as the ‘736 patent) in view of Triplett et al (US 2016/0319217 A1; 11/3/2016. Cited on IDS) and Schaap et al (US 2017/0081684 A1; 3/23/2017.).
Claims 1-10, 13-18, 20-21, 24-26, 28-30, 32-38, and 41 of the ‘736 patent recite a process for obtaining a microbial oil (a lipid) from microbial cells, the process comprising: lysing the cells comprising the microbial oil to form a lysed cell composition, demulsifying the lysed cell composition, separating the oil from the demulsified lysed cell composition, and recovering the oil.
The ‘736 patent does not teach steps (a) and (c)-(e) in claim 1.
Triplett teaches a process for obtaining a microbial oil (a lipid) from microbial cells, the process comprising: lysing the cells comprising the microbial oil to form a lysed cell composition, demulsifying the lysed cell composition, separating the oil from the demulsified lysed cell composition, and recovering the oil (para 0010, 0012). The process comprises heating prior to, during, or after lysing the cells, e.g., from about 60℃ to about 90℃, about 70℃ to about 90℃, about 80℃ to about 90℃ (para 0087, 0089), for a sufficient period of time (para 0088), e.g., 1 hour (para 0114). The process comprises agitating prior to or during lysing of the cells (para 0057-0058), e.g., for 2 hours (para 0114), 8 hours (para 0119), a few hours (para 0115). The process comprises separating the lysed cell composition into different phases including an oil phase, an aqueous phase, and a solid phase (para 0051). The process comprises raising the pH to 8 or above (para 0014, 0042) by adding a base (para 0013, 0043), the pH is from 10 to 12 (para 0045, 0083). The process comprises lowering the pH to 6.5 or less (para 0016, 0042) by adding an acid, the pH is from about 3 to about 6 (para 0047, 0070). The process comprises adding at least one enzyme (para 0015, 0049), the enzymes suitable for forming a demulsified lysed cell composition include beta-glucanase (para 0067). The process comprises adding a salt in an amount of from about 0.05% to about 20% by weight (para 0086). The process comprises lysing microbial cells mechanically (para 0034). The cells are unwashed (para 0036, 0114), the cells are contained in a fermentation broth (para 0036, 0110). The process comprises centrifuging the demulsified lysed cell composition (para 0096). The pH is raised or lowered (para 0014, 0016, 0042), e.g., 7 to 9 (para 0045), 7 to 8 (para 0083). The oil comprises at least 30% by weight docosahexaenoic acid (DHA, an omega-3 fatty acid, a polyunsaturated fatty acid) (para 0102). The microbial cells are from microalgae of the order Thraustochytriales, the genera Schizochytrium (para 0030, 0033). The lysed cell composition comprises liquid, cell debris, and microbial oil (para 0050). The process does not utilize an organic solvent to obtain, separate, or otherwise recover a microbial oil from the microbial cells (para 0095). The enzymes include beta-glucanase (para 0067), in an amount of from about 0.05% to about 10% by weight (para 0068). The salt is an alkali metal salt (para 0084). The microbial oil obtained and/or recovered is a crude oil, the oil is a refined oil (para 0109). The oil has an anisidine value of less than about 20 (para 0103). The oil has a phosphorus content of 100 ppm or less (para 0105). The oil has a peroxide value of less than about 5 meq/kg (para 0104). Triplett teaches the process for obtaining a microbial oil (a lipid) from microbial cells demulsify an emulsified lysed cell composition, allowing the microbial oil to be separated from the lysed cell composition (para 0051). The process comprising demulsifying the lysed cell composition comprises raising the pH of the lysed cell composition to 8 or above to form a demulsified lysed cell composition (para 0014), and demulsifying the lysed cell composition comprises lowering the pH of the lysed cell composition to 6.5 or less to form a demulsified lysed cell composition (para 0016). Triplett teaches chemical treatment includes raising the pH of the cells, lowering the pH of the cells, and combinations thereof (para 0042).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to repeat raising and lowering the pH of microbial cells until the composition is sufficiently demulsified, since ‘736 patent and Triplett both disclose a process for obtaining a microbial oil (a lipid) from microbial cells comprises raising and lowering the pH of the microbial cells, and Triplett discloses that demulsify an emulsified lysed cell composition allows microbial oil to be separated from the lysed cell composition, and demulsifying the lysed cell composition comprises raising the pH of the cells, lowering the pH of the cells, and combinations thereof. In other words, one skill in the art would repeat raising and lowering the pH of microbial cells until a lysed cell composition is sufficiently demulsified, therefore, allow microbial oil to be separated from the lysed cell composition. In addition, Triplett discloses raising and lowering the pH of microbial cells for the same purpose. Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to arranging the steps as a matter of routine experimentation, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells. Finally, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the time period for raising and lowering the pH of microbial cells, since ‘736 patent and Triplett both disclose a process for obtaining a microbial oil (a lipid) from microbial cells comprises raising and lowering the pH of the microbial cells. In other words, raising and lowering the pH of the microbial cells is routinely practiced in the art of obtaining a microbial oil (a lipid) from microbial cells. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to optimize the time period for raising and lowering the pH of microbial cells, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells.
References cited above do not teach the claimed sequence of steps (claims 1-3 and 12-13), and the composition is subjected to one or more cycles of temperature shock (claims 5-6).
However, ‘736 patent and Triplett do teach the process for obtaining a lipid from microbial cells comprises heating microbial cells, separating the microbial cells into a light phase and a heavy phase, raising and lowering the pH of the microbial cells, separating the lipid from a demulsified lysed cell composition, and recovering the lipid, wherein heating temperature is from about 60℃ to about 90℃, about 70℃ to about 90℃, about 80℃ to about 90℃ (para 0087, 0089), for a sufficient period of time (para 0088), and pH is raised from 10 to 12 (para 0045, 0083) and lowered from about 3 to about 6 (para 0047, 0070). Schaap teaches a pasteurization process for microbial cells and microbial oil (Title), comprising heating the microbial cells to a temperature above 60℃, the temperature may rise until a temperature of from 70℃ to 90℃ (para 0023), holding the microbial cells at a desired temperature, suitably from 70℃ to 85℃ (para 0029), and cooling the microbial cells to a temperature below 30℃ (para 0037). Table 2 demonstrates the profile of temperature vs. time, wherein pasteurization for only 1 hour at 70℃ give a peroxide value (POV) of 2.2, and POV of 1.2 at 85℃ (para 0112). Schaap teaches the pasteurization process comprises a heating stage, a plateau stage, and a cooling stage improves the quality of microbial oil obtained from microbial cells, and requires less energy (para 0009, 0027).
‘736 patent and Triplett do teach each and every step of the claims for the same purpose and therefore recognized result effective variables. Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to arranging the steps as a matter of routine experimentation. In addition, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate one or more cycles of temperature shock, since ‘736 patent, Triplett and Schaap all disclose a process for obtaining a lipid from microbial cells comprises pasteurization, physical treatment and chemical treatment, wherein physical treatment includes heating microbial cells at various temperatures, and chemical treatment includes raising and lowering the pH of microbial cells, and Schaap discloses heating and cooling microbial cells more efficiently provide a better quality microbial oil. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to arrange method steps and to incorporate one or more cycles of temperature shock, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells.
References cited above do not teach the claimed percentage of lysed cells (claim 8).
However, ‘736 patent and Triplett do teach the process comprises lysing microbial cells mechanically.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to mechanically disrupting microbial cells to achieve a desired result, since lysing microbial cells mechanically is routinely practiced in the art of obtaining a microbial oil (a lipid) from microbial cells, as evidenced by Triplett. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to mechanically disrupting microbial cells to achieve a desired result, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells.
Response to Arguments
Applicant argues that Triplett in view of Schaap does not teach or suggest “concentrated microbial cell composition” recited in element (b) of claim 1, that Triplett does not disclose element (b) at [0051], and therefore does not teach or suggest elements (c)-(e) of claim 1.
These arguments are not found persuasive because according to the instant specification, para 0076, the “concentration process comprises heating a composition comprising microbial cells, such as a fermentation broth, to a temperature of about 60℃ to about 95℃, … at a pH of about 6 to about 9, … under agitation for a period of time from about 1 hour, 2 hours, … to concentrate the population of microbial cells, and separating the concentrated microbial cells into a light phase and a heavy phase.” Triplett does teach the process comprising heating a microbial cell and/or a lysed microbial cell composition, e.g., from about 60℃ to about 90℃, about 70℃ to about 90℃, about 80℃ to about 90℃ to remove water present in the cells and/or the lysed cell composition (concentrating) (para 0087, 0089), at a pH of 8 to 9 (para 0045), agitating prior to or during lysing of the cells (para 0057-0058), e.g., for 2 hours (para 0114), and separating the lysed cell composition into different phases including an oil phase, an aqueous phase, and a solid phase (para 0051). Since Triplett does teach the same concentration process and separation step as disclosed in para 0076 of the instant specification, the light phase of Triplett after the same concentration process and separation step does consists essentially of a concentrated microbial cell composition as claimed. Applicant may amend element (b) in claim 1 to better distinguish the separation step from the prior art. In addition, Triplett does teach treating microbial cells by heating, separating the treated microbial cells, pH adjusting, separating out lipid, and recovering the lipid, it would have been obvious to one of ordinary skill in the art to arranging the steps as a matter of routine experimentation, with a reasonable expectation for successfully obtaining a microbial oil (a lipid) from microbial cells.
Applicant argues that the examiner uses improper hindsight.
These arguments are not found persuasive because it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant argues that claim 1 of Triplett states at a pH of 2 or lower or 10 or higher, whereas the sequence of steps (c)-(e) of pending claim 1 state a pH of about 10 to about 12 and followed by a pH of about 3 to about 6, and that claim 1 of Triplett states at a pH of 2 or lower, whereas claim 1 of the pending application states at a pH of from about 3 to about 6.
These arguments are not found persuasive because claims are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-10, 13-18, 20-21, 24-26, 28-30, 32-38, and 41 of U.S. Patent No 11,124,736 (referred to as the ‘736 patent) in view of Triplett et al (US 2016/0319217 A1; 11/3/2016. Cited on IDS) and Schaap et al (US 2017/0081684 A1; 3/23/2017.). Triplett et al (US 2016/0319217 A1; 11/3/2016. Cited on IDS) does teach the method wherein pH is raised from 10 to 12 (para 0045, 0083), and pH is lowered from about 3 to about 6 (para 0047, 0070).
Conclusion
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759