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 .
Election/Restrictions
Applicant’s election of claims 1-12 in the reply filed on December 8, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 14 and 15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 4 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.
With respect to Claim 4, the recitation “wherein the seed material and non-seed plant material are selected from the following plant source combinations: a. hemp and plum; b hemp and pumpkin; c. chia and lentil; d. flax and plum; and e. walnut and lentil” in lines 1-7, fails to specify each material in the combination. It is unclear whether the material is seed material or non-seed plant material. For the purposed of examination, the recited materials in the list will be interpreted as either seed or non-seed plant material.
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 (i.e., changing from AIA to pre-AIA ) 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, 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 1, 2, 4-5, 8-12, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Galley et al. (WO 2007/122422 A2).
With respect to Claims 1 and 18, Galley et al. teaches a method of preparing an oil body solution comprising extracting oleaginous compositions from plant material and combining with an aqueous medium, then separating out the oil phase. [Pg. 7, Ln. 21-29] Galley et al. teaches the use of plant material from a variety of sources, including the seeds. [Pg. 9, Ln. 11-27] Galley et al. teaches that the oil body solution can comprise between 1-35% protein. [Pg. 14, Ln. 3-4] The method of Galley et al. comprises adding seeds to the extraction media, which comprises a buffer with a pH of 7.5, then homogenizing into a slurry, filtrating and centrifuging the slurry. [Pg. 27, Ln. 25-29] Additionally, the oil body composition is freeze dried. [Pg. 28, Ln. 21-22]
Galley et al. is silent to the ratio of plant tissue to seed, but teaches that the oil body solution can be produced with any oleaginous plant tissue material and seed material. The composition of Galley et al. is primarily seed material, a composition of 100% seed material is close to 95% seed material as recited in claim 1. MPEP 2144.05 I states, “a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. Additionally, the protein content taught in the oil body composition of Galley et al. overlaps with the protein content of the non-seed plant material. MPEP 2144.05 I also states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”.
Additionally, Galley et al. teaches buffering the oil body solution to a pH between 6.5 and 10, before the homogenization step. [Pg. 27, Ln. 25-29] MPEP 2144.04 IV. C, states, “Selection of any order of mixing ingredients is prima facie obvious”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. to develop a method of preparing an oil body solution, wherein the suspension comprises seed and non-seed plant material between 50:50 and 95:5, wherein the non-seed plant material has a protein content between 4-25%, adjusting the pH of the solution to above 6, mechanically forming a slurry, diluting the slurry with a buffer, wherein the buffer has a pH between 6.5-10, filtering and centrifuging the slurry to form an oil body solution, and freeze drying the oil body solution to form a powder, thereby rendering claim 1 obvious.
With respect to Claim 2, Galley et al. teaches the invention recited in claim 1, as described above. Additionally, the protein content of the oil curd is taught to be 1-35%, [Pg. 14, Ln. 3-4] and the carbohydrate content is taught to be between 0.01-40%. [Pg. 17, Ln. 21-25] The plant material used in the composition would comprise an amount of protein and carbohydrate that overlaps with the amount in the final oil body solution, both of which overlap with the amount recited in claim 2. MPEP 2144.01 I states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. to develop a method of creating an oil body solution, wherein the protein content of the seeds is between 13-30% and the carbohydrate content is between 8-27% and the carbohydrate content of the plant material is between 16-35%, thereby rendering claim 2 obvious.
With respect to Claim 4, Galley et al. teaches the invention recited in claim 1, as described above. Additionally, Galley et al. teaches the use of hemp and pumpkin. [Table 1] MPEP 2144.06 I states, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. to develop a method of producing an oil body composition using hemp and pumpkin seed, thereby rendering claim 4 obvious.
With respect to Claims 5, 16, and 17, Galley et al. teaches the invention recited in claim 1, as described above. Additionally, Galley et al. teaches suspending the plant material in an aqueous solution of phosphate buffer of pH 7.5, homogenizing the composition in the solution, and maintaining the pH of 7.5 in the curd composition. [Pg. 27, Ln. 25-33] Therefore, Galley et al. reads on claims 5, 16, and 17.
With respect to Claim 8, Galley et al. teaches the invention recited in claim 1, as described above. Additionally, Galley et al. teaches homogenizing the solution in a blender. [Pg. 27, Ln. 26-27] Therefore, Galley et al. reads on claim 8.
With respect to Claims 9 and 11, Galley et al. teaches the invention recited in claim 1, as described above. Additionally, Galley et al. teaches the average particle size of the oil body composition is between 0.1-10 µm, [Pg. 15, Ln. 8-11] and teaches filtering the slurry to obtain the oil body composition. [Pg. 27, Ln. 27-28] The range of particle size overlaps with the range recited in claim 11, and the method of particle size reduction is the same as recited in claim 9. Galley et al. is silent to the pore size of the filter, but MPEP 2112.01 I states, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”. Additionally, MPEP 2144.05 I states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. The process and composition taught by Galley et al., as substantially identical to the process and composition recited in claims 9 and 11, would utilize a filter with a pore size identical to the size recited in claim 9. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. in order to develop a method of producing an oil body solution wherein the solution is passed through a filter with a pore size of 200 µm or less and an average particle size between 4 and 26 µm, thereby rendering claims 9 and 11 obvious.
With respect to Claim 10, Galley et al. teaches the invention recited in claim 9, as described above. The method of Galley et al. comprises adding seeds to the extraction media, which comprises a buffer with a pH of 7.5, then homogenizing into a slurry, filtrating and centrifuging the slurry. [Pg. 27, Ln. 25-29] The pH of the buffer taught by Galley et al. reads on the pH of the recited solution. Additionally, the first and second retentate are fundamentally identical products that would be combined to form a third product for the same purpose, and MPEP 2144.06 I states, “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose”.
The recitation in claim 10 of, “filtered using a filter with a pore size of 200 µm or less, to provide a second retentate separated from a second filtrate”, amounts to a duplication of the method step recited in claim 9 of, “filtered using a filter with a pore size of 200 µm or less, to provide a first retentate separated from a first filtrate”. MPEP 2144.04 states, “that mere duplication of parts has no patentable significance unless a new and unexpected result is produced”. It would have been obvious to filter the retentate a second time in order to produce a more purified product.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. to develop a method of producing an oil body according to claim 9, wherein the method comprises suspending the first retentate in a buffer with a pH between 6.5-10, filtering through a 200 µm pore filter in order to obtain a second retentate, then combining the first and second retentate to produce the oil body solution, thereby rendering claim 1o obvious.
With respect to Claim 12, Galley et al. teaches the invention recited in claim 1, as described above. Though Galley et al. is silent to the solids content of the oil body, the process and composition taught by Galley et al. is substantially identical to the process and composition taught in claim 1. According to MPEP 2112.01 I, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”, therefore, it would have been obvious for the solids content to be identical to the amount recited in claim 12.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. to produce a method of extracting oil bodies from plant material according to the method of claim 1, wherein the solids content is between 1-15%, thereby rendering claim 12 obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Galley et al. (WO 2007/122422 A2) in view of Gray (WO 2012/110797 A1).
With respect to Claim 3, Galley et al. teaches the invention recited in claim 1, as described above, but is silent to the omega-3 composition of the plant material.
Gray teaches a method of extracting an oil body from plant material and drying extracted oil. [Pg. 1, Ln. 3-4] Additionally, Gray teaches the beneficial effects of omega-3 fatty acids for medical and dietary reasons, [Pg. 1, Ln. 25-26] and teaches that omega-3 fatty acids can be extracted from plant seeds. [Pg. 2, Ln. 19-22]
Galley et al. and Gray et al. exist within the same field of endeavor in that they teach extraction processes for oil body solutions from plant material. Where Galley et al. teaches a general method of oil body solution extraction, Gray et al. teaches that omega-3 fatty acids are beneficial for nutritional and medical reasons. Though both references are silent to the omega-3 fatty acid content of the material, the process and composition taught by Galley et al. is substantially identical to the process and composition taught in claim 1. According to MPEP 2112.01 I, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established”, therefore, the composition would possess the amount of omega-3 fatty acid recited in claim 3.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. in view of Gray to produce a method of extracting an oil body from plant material as recited in claim 1, wherein the omega-3 fatty acid content of the seed material is between 10-60%, thereby rendering claim 3 obvious.
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Galley et al. (WO 2007/122422 A2) in view of Deckers et al. (6,146,645).
With respect to Claims 6 and 7, Galley et al. teaches the invention recited in claim 1, as described above, but is silent to the temperature at which the composition is processed.
Deckers et al. teaches a method of extracting oil body solutions from plant material, [Col. 4, Ln. 15-20] wherein the temperature of the liquid before extraction is between 10-90°C. [Col. 8, Ln. 23-25] Additionally, Deckers et al. teaches imbibing the plant material for between 15 minutes to 2 days, prior to grinding. [Col. 8, Ln. 1-2] This temperature range overlaps with both temperature ranges recited in claim 6 and the time overlaps with the time recited in claim 7. MPEP 2144.05 I states, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Additionally, it would have been obvious to use a liquid to soak the seeds at a temperature for wet milling before being added to the mill, because according to MPEP 2144.04 IV C states, “Selection of any order of mixing ingredients is prima facie obvious”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Galley et al. in view of Deckers et al. in order to develop a method according to claim 1, wherein the suspension in step a) is heated to between 90-120°C and cooled to 4-30°C for at least one hour, thereby rendering claim 6 and 7 obvious.
Conclusion
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791