DETAILED ACTION
For this Office action, Claims 18-34 are pending. Claims 1-17 are canceled.
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 Rejections - 35 USC § 112
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.
Claim 31 is 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. Claim 31 recites optional limitations regarding the ways at least one PUFA product can be obtained from partial purification of a natural or synthetic feedstock. These limitations render the claim indefinite, as the language is unclear whether or not the optional ways are required to read on the claim or not. For purposes of this examination, the examiner will assume the optional limitations are NOT required to read on Claim 31.
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.
Claims 18, 20-22 and 25-34 are rejected under 35 U.S.C. 103 as being unpatentable over Kelliher et al. (herein referred to as “Kelliher”, US Pat Pub. 2014/0200360).
Regarding instant Claim 18, Kelliher discloses a chromatographic separation process for recovering a polyunsaturated fatty acid (PUFA) product from a feed mixture, which comprises introducing the feed mixture into a chromatography apparatus comprising one or more chromatographic columns (Abstract; chromatographic separation process for PUFA from feed mixture using chromatographic columns) containing:
a liquid eluent phase which is an aqueous organic solvent (Abstract; liquid eluent phase is an aqueous organic solvent); and
a solid adsorbent phase which is a C18-bonded silica (Paragraph [0080]; silica bonded with c18 alkanes),
wherein the pressure within the one or more chromatographic columns being less than 20 bar (Paragraph [0016]; process occurs at standard pressure), thereby resulting in purification of the feed mixture (Paragraph [0019]; Paragraph [0045]; highly purified product).
While the reference is silent on an average particle diameter of from 230 to 270 μm and a Dv(10) of 160 μm or greater, the reference does disclose particle diameters within this range (Paragraph [0081]; see 100 to 500 μm). Furthermore, Kelliher further discloses that the sizes of the particles can be adjusted to account for optimizing advantages such as eluent pressure, cost savings, efficiency and lifetime of the apparatus (Paragraph [0081]). Therefore, it would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the particle size of the silica to have an average diameter of from 230 to 270 μm and a Dv(10) of 160μm or greater (wherein Dv(10) is a standard deviation of particles size) as taught by Kelliher in order to optimize eluent pressure, cost savings, efficiency and lifetime of the apparatus (Paragraph [0081]).
Additionally, the MPEP warns against patentability for changes in size or proportion, see MPEP 2144.04 II. VI. A, as quoted here. “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. Since the only difference between the prior art and the instant claim is the change in size of the silica particles, and the prior art discloses the motivations for changing said size, the change is considered obvious to one of ordinary skill in the art at the time of the effective filing date of the invention for the reasons detailed above.
Regarding instant Claim 20, Claim 18, upon which Claim 20 is dependent, has been rejected above. Kelliher further discloses wherein the silica ha an average particle diameter of 230 to 270 μm (Paragraph [0081]; see Claim 18 rejection above).
Regarding instant Claim 21, Claim 18, upon which Claim 21 is dependent, has been rejected above. Kelliher further discloses wherein the silica has a Dv(10) of 160 μm or a Dv(10) of 225 μm or less (Paragraph [0081]; limitation renders any and all Dv(10) values available to read on the claim).
Regarding instant Claim 22, Claim 18, upon which Claim 22 is dependent, has been rejected above. Kelliher further discloses wherein the silica has an average particle diameter of from 230 to 270 μm and a Dv(10) of from 160 to 225 μm (Paragraph [0081]; see Claim 18 rejection above).
Regarding instant Claim 25, Claim 18, upon which Claim 25 is dependent, has been rejected above. Kelliher further discloses wherein the silica has a surface area of 500 m2/g or less or a surface area of 200 m2/g or more (Paragraph [0081]; Table 3, see that particles would have surface area and “or” option covers all surface areas).
Regarding instant Claim 26, Claim 18, upon which Claim 26 is dependent, has been rejected above. Kelliher further discloses wherein the silica:
has a Dv(10) of 170 μm or greater; and/or
has an average particle diameter of from 250 to 260 μm (Paragraph [0081]; see Claim 18 rejection above).
Regarding instant Claim 27, Claim 18, upon which Claim 27 is dependent, has been rejected above. Kelliher further discloses wherein at least 80% of the silica particles by volume have a diameter of from 200 to 500 μm (Paragraph [0081]; see Claim 18 rejection above).
Regarding instant Claim 28, Claim 18, upon which Claim 28 is dependent, has been rejected above. Kelliher further discloses wherein the aqueous organic solvent is a mixture of water and an alcohol, an ether, an ester, a ketone or a nitrile (Claim 8).
Regarding instant Claim 29, Claim 18, upon which Claim 29 is dependent, has been rejected above. Kelliher further discloses wherein the pressure within the one or more chromatographic columns is less than 10 bar (Paragraph [0016]; process occurs at standard pressure).
Regarding instant Claim 30, Claim 18, upon which Claim 30 is dependent, has been rejected above. Kelliher further discloses wherein the chromatography apparatus is a simulated moving bed (SMB) chromatography apparatus (Abstract; Paragraph [0085]; SMB process).
Regarding instant Claim 31, Claim 18, upon which Claim 31 is dependent, has been rejected above. Kelliher further discloses wherein the feed mixture is a natural or synthetic feedstock comprising at least one PUFA product (Paragraph [0017]; Paragraph [0018]; PUFA product derived from natural feedstocks such as fish oil).
Regarding instant Claim 32, Claim 18, upon which Claim 32 is dependent, has been rejected above. Kelliher further discloses wherein: introducing the feed mixture into the chromatography apparatus results in purification of the feed mixture to yield the PUFA product (Abstract; Paragraph [0045]; see purification of feed mixture that yields in PUFA product).
Regarding instant Claim 33, Claim 18, upon which Claim 33 is dependent, has been rejected above. Kelliher further discloses wherein the PUFA product comprises a PUFA (Paragraph [0045]; output is PUFA with greater than 97% purity).
Regarding instant Claim 34, Claim 18, upon which Claim 34 is dependent, has been rejected above. Kelliher further discloses wherein: the PUFA product is produced in a purity of greater than 80 wt% (Paragraph [0045]; PUFA with preferably greater than 97% purity).
Claims 19, 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Kelliher et al. (herein referred to as “Kelliher”, US Pat Pub. 2014/0200360) as applied to claim 18 above, and further in view of Thompson et al. (herein referred to as “Thompson”, WO 2012/048185).
Regarding instant Claim 19, 23 and 24, Claim 18—upon which each of the claims are dependent—has been rejected above. Kelliher discloses wherein the silica has an average particle diameter of from 230 to 270 μm and a Dv(10) of 160 μm (Paragraph [0081]; see Claim 18 rejection above).
However, the reference is silent on silica surface area and carbon loading.
Thompson discloses carbon composite materials for separations in the same field of endeavor as the instant application, as it solves the mutual problem of providing substrates for chromatographic separation using silica (Abstract; Figure 9; Page 1, Lines 16-27; Page 11, Lines 11-17; Page 27, Line 26-31). Thompson further discloses standard chromatographic substrates purchased from a supplier that comprise a carbon loading of 17% and surface area of preferable 100-300 m2/g (Page 11, Lines 11-17; Page 27, Line 26-31).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the surface area and the carbon loading of the silica of Kelliher to be 100-300 m2/g and 17% respectively as taught by Thompson because Thompson discloses these are ideal values for silica substrates in chromatographic separation and may be purchased with these parameter values (Thompson, Page 11, Lines 11-17; Page 27, Line 26-31; see Claim 19; Claim 23 and Claim 24 are also rejected since carbon loading is within range at 17%).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kirkland et al. (US Pat Pub. 2007/0189944) discloses average surface areas of porous microparticles used for chromatography separation within the ranges desired by the instant claims (Abstract; see values for particle diameter and surface area), showing the particle parameters recited in the instant claims are considered known in the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD C GURTOWSKI whose telephone number is (571)272-3189. The examiner can normally be reached 9:00 am-5:30pm MT.
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/RICHARD C GURTOWSKI/ Primary Examiner, Art Unit 1773 08/19/2026
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