DETAILED ACTION
Claim Rejections - 35 USC § 102/103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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.
Claims 1-4, 6-13, 17-24 and 26-35 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Barz (WO 2018011286).
With respect to claim 1, Barz discloses a process for obtaining lipid from a composition comprising microbial cells. Example 1 on page 18 provides a basic outline. Cell broth is heated to a temperature between 60°C and 80°C (“An unwashed cell broth containing microbial cells (Schizochytrium sp.) at a biomass density of over 100 g/l was heated to 60°C in an agitated vessel”). One or more enzymes are added for a time sufficient for cell lysis, and the cells are heated up to 80°C to form a lysed cell composition (“an alcalase (Alcalase® 2.4 FG (Novozymes)) was added in liquid form in an amount of 0.5 wt.-% (by weight broth). Stirring was continued for 3 hours at 60°C. After that, the lysed cell mixture was transferred into a forced circulation evaporator (obtained from GEA, Germany) and heated to a temperature of 85°C”). Those of ordinary skill would have found Barz’s heating to 85°C to be essentially equivalent and an obvious variation to the claimed requirement of “up to 80°C “. The lysed cell composition is heated to a temperature of about 80°C to 90°C (“the concentrated lysed cell mixture was transferred into a new vessel, heated up to 90°C under low shear agitation”). Continuing with Example 1, Barz states that the pH of the lysed cell composition is adjusted to between about 10 to about 12 by adding a base, and that the pH is maintained for at least 1 hour (“adjusting the pH to 10.5 by adding caustic soda. Low shear agitation was continued for about 30 hours, while keeping the temperature at 90°C and the pH above 9.0 by adding caustic soda”). The pH of the lysed cell composition is then adjusted downward to between about 4 to about 6 by adding an acid. This pH is maintained for at least 0.5 hours (“After that the resulting demulsified mixture was neutralized by adding sulfuric acid to adjust a pH of 7.5”). Page 4 clarifies that neutralization using an acid may adjust the pH downward to about 5.5 and may be characterized by a duration from several minutes up to several hours. Barz teaches in Example 1 that the lipid is separated and recovered from the demulsified lysed cell composition (“Phase separation into a light phase, containing the oil, and a heavy phase, containing water, cell-debris, residual oil and salts, was carried out mechanically by using a disc stack separator”).
In the event that Barz does not strictly read on the specific sequence of claimed heating, pH adjustment and separation steps, it is noted that dividing a singular heating/neutralizing/separation into a multistep process is essentially arbitrary and would not affect lipid extraction. It is within the ability of those of ordinary skill to make minimal changes to the Barz sequence of operation in order to obtain predictable results.
With respect to claim 2, Barz discloses the method as described above. Barz further indicates on page 17 that the initial pasteurization step is not limited to 60°C, but may be conducted at essentially any temperature between 50 to 121°C. Accordingly, those of ordinary skill would have considered heating the composition in step (a) to about 80°C.
With respect to claim 3, Barz discloses the method as described above. As previously discussed, Barz states that pH should be adjusted to ensure optimum enzyme performance in steps (a) and/or (b) (“an enzyme with a pH optimum of between 6.5 and 8.5, preferably of between 7.0 and 8.0, in particular of about 7.5, is used, so that the pH applied in this step is from 6.5 to 8.5, in particular from 7.0 to 8.0, preferably from 7.3 to 7.7. A preferred enzyme which can be used in this pH range is an alcalase”).
With respect to claim 4, Barz discloses the method as described above. A repetition of the heat shock step already taught by Barz would produce a predictable and/or redundant and/or cumulative effect, and therefore would be prima facie obvious.
With respect to claims 6 and 27, Barz discloses the method as described above. Barz indicates that the salt may be added to the lysed cell composition in an amount greater than 0.05% by weight (“In this embodiment preferably less than 1 wt.-% of chloride salts, more preferably less than 0.5 or 0.2 wt.-% of chloride salts are used for isolating the oil from the biomass”). Those of ordinary skill would have found it obvious to use available alkali metal, alkali earth and/or sulfate salts. Barz specifically mentions sodium chloride.
With respect to claims 7-9, Barz discloses the method as described above. Barz indicates that the cells are unwashed and derived from an agitated fermentation broth. See again Example 1 (“An unwashed cell broth containing microbial cells (Schizochytrium sp.) at a biomass density of over 100 g/l was heated to 60°C in an agitated vessel”).
With respect to claim 10, Barz discloses the method as described above. Barz discloses that the separation step may include centrifugation (“Separation of the oil containing light phase from the water, salts and cell debris containing heavy phase is preferably realized by mechanical means and preferably at a temperature of 60-90°C, more preferably 70-80°C, and at a pH value of preferably 6-9, more preferably 7-8.5. "Mechanical means" refers in particular to filtration and centrifugation methods as known to those skilled in the art”).
With respect to claims 11-13, Barz discloses the method as described above. Barz teaches the recovery of omega-3 and omega-6 fatty acids, as well as DHA, EPA, etc.
With respect to claims 17-22, Barz discloses the method as described above. Barz indicates that the lipids are obtained from a wide variety of cells, including algae, yeast, fungi, protist and bacteria. Barz specifically mentions microbial cells from the order Thraustochytriales. It would have been within the ability of one of ordinary skill to select a particular cell type for producing and recovering lipids.
With respect to claim 23, Barz discloses the method as described above. Barz states that organic solvent is not necessary (“A particular advantage of the method of the current invention is that it can be carried out without the use of any organic solvent”).
With respect to claims 24 and 26, Barz discloses the method as described above. Barz teaches the use of enzymes, such as proteases, cellulases, hemicellulases, chitinases, pectinases, sucrases, maltases, lactases, alpha-glucosidases, beta-glucosidases, amylases, lysozymes, neuraminidases, galactosidases, alpha-mannosidases, glucuronidases, hyaluronidases, pullulanases, glucocerebrosidases, galactosylceramidases, acetylgalactosaminidases, fucosidases, hexosaminidases, iduronidases, maltases-glucoamylases, beta-glucanases, mannanases, and combinations thereof (“The enzyme is preferably added as a concentrated enzyme solution, preferably in an amount of 0.01 to 1.5 wt.-%, more preferably in an amount of 0.03 to 1 .0 wt.-%, above all in an amount of 0.05 to 0.5 wt.-%, relating to the amount of concentrated enzyme solution as added in relation to the total amount of the suspension after addition of the concentrated enzyme solution”).
With respect to claims 28-35, Barz discloses the method as described above. Barz further indicates that the recovered lipid includes an anisidine value of less than 26 and a peroxide value of less than 5 meq/kg. Those of ordinary skill would have recognized that the Barz method could be used to recover a wide variety of value lipid products.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as unpatentable over Barz (WO 2018011286) as applied to claim 1, and further in view of Schaap (US 20170081684).
Barz discloses the method as described above, however does not appear to disclose a temperature shock treatment.
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).
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 Barz 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.
Response to Arguments
In response to Applicant’s amendment filed 05 December 2025, the previous rejection under 35 U.S.C. 102 has been withdrawn.
In response to Applicant’s amendment filed 05 December 2025, the previous rejection under 35 U.S.C. 112 has been withdrawn.
The objection to the Figures has been withdrawn.
In response to Applicant’s amendment filed 05 December 2025, a new ground of rejection is made in view of the Barz reference.
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 1-13, 17-24 and 26-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16, 20-27 and 29-38 of copending Application No. 17/439,134 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of copending Application No. 17/439,134, particularly claim 1, include limitations drawn to:
A process for obtaining a lipid from a composition comprising microbial cells, the process comprising:
a) heating the composition comprising the microbial cells to a temperature of about 60°C to about 80°C;
b) adding one or more enzymes capable of disrupting the cell wall of the microbial cells for a time sufficient for lysis of the microbial cells and heating the microbial cells up to 80°C to form a lysed cell composition;
c) heating the lysed cell composition to a temperature of about 80°C to about 90°C;
d) adjusting the pH of the lysed 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;
e) adjusting the pH of the lysed cell composition obtained in step (d) to a pH of about 4 to about 6 by adding an acid and maintaining the pH of about 4 to about 6 for at least 0.5 hours to obtain a demulsified lysed cell composition;
f) optionally repeating steps (c) and (d) until said composition is sufficiently demulsified to obtain the demulsified lysed cell composition;
g) separating the lipid from the demulsified lysed cell composition; and
h) recovering the lipid.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 17-24 and 26-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Pat. No. 11,946,017.
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of U.S. Pat. No. 11,946017, particularly claim 1, include limitations drawn to:
A process for obtaining a lipid from a composition comprising microbial cells, the process comprising:
a) heating the composition comprising the microbial cells to a temperature of about 60°C to about 80°C;
b) adding one or more enzymes capable of disrupting the cell wall of the microbial cells for a time sufficient for lysis of the microbial cells and heating the microbial cells up to 80°C to form a lysed cell composition;
c) heating the lysed cell composition to a temperature of about 80°C to about 90°C;
d) adjusting the pH of the lysed 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;
e) adjusting the pH of the lysed cell composition obtained in step (d) to a pH of about 4 to about 6 by adding an acid and maintaining the pH of about 4 to about 6 for at least 0.5 hours to obtain a demulsified lysed cell composition;
f) optionally repeating steps (c) and (d) until said composition is sufficiently demulsified to obtain the demulsified lysed cell composition;
g) separating the lipid from the demulsified lysed cell composition; and
h) recovering the lipid.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799
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