Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claims 4-43 and 47-51 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claims.
See MPEP § 608.01(n). Accordingly, claims 4-43 and 47-51 have not been further treated on the merits.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, and 44, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ruecker (USP 7351558).
Regarding claim 1, Ruecker teaches, “The present invention provides a process for obtaining lipid from microorganisms comprising: (a) lysing cells of the microorganisms to produce a lysed cell mixture; (b) treating the lysed cell mixture to produce a phase separated mixture comprising a heavy layer and a light layer; (c) separating the heavy layer from the light layer; and (d) obtaining the lipid from the light layer. The lysed cell mixture may contain an emulsion, in which case the emulsion can be separated by centrifuging the lysed cell mixture. The separated lysed cell mixture comprises a heavy layer which contains aqueous solution and a light layer which contains lipids, which may be emulsified. The aqueous solution comprises solid cell materials which results from lysing cells. The light layer can be further washed with an aqueous washing solution until the lipid becomes substantially non-emulsified. (Col 2 Ln 6-24)”
Regarding claim 1 and the limitation “(a) lysing the cells comprising the microbial oil to form a lysed cell composition;”, Rueker teaches lysing the cells (Col 2 Ln 8-9).
Regarding claim 1 and the limitation “(b) treating the lysed cell composition to form an oil-containing emulsion;” Reucker teaches that the oil may be in an emulsion phase and further teaches steps to produce emulsions, (Col 2 Ln 16-19, Col 4 Ln 59-63, Col 4 Ln 35-40). As an emulsion has been formed the lysed cell composition has been treated to form an oil containing emulsion.
Regarding claim 1 and the limitation “(c) separating the oil-containing emulsion from the lysed cell composition;”, Ruecker teaches steps of separating the emulsion, from the heavy phase containing lysed cells(Col 2 Ln 12-19,Col 4 Ln 59-65).
Regarding claim 1 and the limitation “(d) demulsifying the oil-containing emulsion; and”, Reucker teaches performing a set of steps of water washing to demulsify the emulsion and isolate the lipids/oil (Col 4 Ln 65-Col 5 Ln 6).
Regarding claim 1 and the limitation “(e) recovering the oil.” Ruecker teaches isolating the light phase until a lipid layer is obtained and further teaches that the lipid is isolated, (Col 2 Ln 14-15, Col 4 Ln 65-Col 5 Ln 21)
Regarding claim 2 and the limitation “wherein at least one of (a) or (b) further comprises raising the pH of the cells or the lysed cell composition.”, Reuker teaches adding base to the fermentation broth while lysing the cells ((Col 5 Ln 51-58, Claim 1).
Regarding claim 3, and the limitations “, wherein at least one of (a) or (b) further comprises raising the pH to about 7 or above.”, Ruecker teaches that the addition of base in the examples result in a pH above about 7 (See Table 2).
Regarding claim 44, limitations a-e have been addressed above, regarding the limitation “wherein at least one of (a) and (b) comprises raising the pH of the cells or lysed cell composition, agitating the cells or lysed cell composition, and heating the cells or lysed cell composition.”, Ruecker teaches that the step of lysing the cells includes raising the pH by the addition of a base, heating the composition and further teaches that the cells may be lysed by steps which result in agitation of the cells, such as homogenization(Col 5 Ln 51-58, Claim 1, Col 4 Ln 43-46, Col 4 Ln 35-40).
The above reference anticipates the claim subject matter.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-3, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Reucker as applied to claim claims 1-3 and 44 above, and further in view of Cherinko (USPGPub 20110295028).
For a discussion of what Reucker teaches, see the above sections. Reucker teaches methods of lysing cells as well as obtaining the lipid phase from the emulsion, i.e. breaking the emulsion, which require steps of washing the isolated emulsion with water. Reucker does not teach steps known in the art to aid in the lysing of cells or breaking of emulsions such as the addition of enzymes, the addition of salt, or heating the emulsion. These steps would have been obvious however as they are known in the same field of endeavor as organic solvent free extraction of microbial oils by Cherinko.
Regarding claims 3 and the limitations “, wherein at least one of (a) or (b) further comprises raising the pH to about 7 or above.”, and “, Reucker does not teach a specific pH to obtain with the addition of base; however, Cherinko teaches a pH range of at least 8, ([0065]). One of ordinary skill in the art would find it obvious that the base added to aid in the lysing of the cells could be added to a pH of at least 8 as Cherinko teaches such a range for this step.
Regarding claims 45 and the limitation “wherein (a) further comprises adding an enzyme in an amount of from about 0.05% to about 20% by weight of the cell broth.”, Cherinko teaches that enzymes can aid in the lysing of cells([0130]). Cherinko further teaches adding enzymes in several examples ([0219], [0221], [0222, [0223], [0224]). In addition, the amount of enzyme added to aid in lysing the cells can be considered a result effective variable. It is well within the skill of one of ordinary skill in the art to determine effective ranges to use a component that is a result effective variable. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980).
One of ordinary skill in the art would find it obvious that enzymes could be added to the fermentation broth to aid in the lysing of the cells as such steps are known in the art as taught by Cherinko. One of ordinary skill in the art would be motivated to do so to improve the lysing of the cells which contain the oil product with is subsequently isolated.
Regarding claim 46 and the limitation “wherein (b) further comprises adding a salt in an amount of from about 0.05% to about 20% by weight of the cell broth.”, Cherinko teaches that salt may be added to the broth containing the lysed cell composition and teaches 0.5 to 15 % weight ([0003]). This range is within the instantly claimed range and renders it obvious.
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 1-3 and 44-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 12104139. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘139 teach a methods steps matching those claimed with additional limitations of addition citric acid and base, claims 1-3 of ‘139 share the limitation of instant claims 1-3, and claims 40-42 of ‘139 share the limitations of instant claims 44-46. The claims of ‘139 thus fall within the scope of the instant claims and render them obvious.
Conclusion
No claim is allowed.
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/CHARLES Z CONSTANTINE/Examiner, Art Unit 1657
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