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 without traverse of Group I, claims 18-40 in the reply filed on 1/23/2026 is acknowledged.
Claims 41-46 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 § 102
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 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 18-21 and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kessler et al (US 8,282,831 B2).
With respect to claim 18, Kessler teaches a method for chromatographic separation in which a multicomponent mix is fed for separation into streams including a raffinate stream (defined by a non-target component) and an extract (defined by a target component); The process includes recirculation of the streams e.g. the raffinate stream [Abs]. The definition of the streams and the decision as to when to recirculate i.e. a raffinate may be determined based on the concentration of e.g. the target component falling below a threshold [Col. 12 lines 32-51]. This recirculation entails combining the stream e.g. the raffinate stream with the feed (45) [Fig. 6].
With respect to claim 19, Kessler teaches an example with a feed concentration of 1/1 between the target and non-target substance [Table 1] and as above suggests recirculation when the target component drops below a target purity threshold i.e. a threshold more consistent with the output product; as such, the recirculated fractions would still have a higher concentration of the product compared to the feed because they would include fractions whose value is just outside of the product threshold but is nevertheless still higher than e.g. a 1/1 ratio of the feed.
With respect to claim 20, Kessler teaches an embodiment in which the raffinate stream may also be diverted for further handling rather than recirculated if it is a high enough purity, such that only the relatively mixed streams are recycled and values which are more varied are discharged [Col. 7 lines 46-58].
With respect to claim 21, the target value may be a minimum content i.e. a minimum acceptable purity for the extract, although the process may also be operated in e.g. an extract-recirculation mode which may be considered using a standard of a maximum content i.e. a maximum acceptable contamination standard.
With respect to claim 24, Kessler teaches that the process may be carried out in a continuous mode [Col. 6 lines 26-33].
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 18-21, 24, 26, 28-30, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Perrut et al (US 5,719,302 A) in view of Kessler et al.
With respect to claim 18, Perrut teaches processes for recovering purified polyunsaturated fatty acids (PUFA) using chromatographic methods [Abs] and teaches employing processes in which fractions are processed using various embodiments and, in each case, certain fractions may be passed for further processing or recovered, while some fractions may be discarded, recycled, or returned to the feed mixture of the first step for further fractionation [Col. 10 lines 33-65]. Perrut does not explicitly teach that these fractions and the decision as to whether to recycle or process is based on the content of a desired target within the fraction. However, see the discussion of Kessler above; separating an extract fraction when it is of sufficient purity, and discarding or recycling a raffinate fraction when the target substance purity is not sufficiently high would have been an obvious means to determine which fractions should be processed in which manner when separating mixtures in which a particular substance is the primary target and purification is desired. The claimed invention would have been obvious in view of such combination.
With respect to claims 19-21, see the discussion of Kessler above; Kessler teaches or at minimum suggests separations according to the claimed logic i.e. recycling fractions which may be higher purity than the feed but nevertheless are insufficient for the product extract, and further separating or discarding the raffinate based on concentration of a contaminant or the like, and otherwise using maximum or minimum thresholds (e.g. for contaminant and/or target) as the criteria for processing.
With respect to claim 24, Perrut teaches continuous processes [Abs].
With respect to claim 26, as above Perrut teaches that fractions may be returned to the feed mixture in embodiments, such that mixing with said feed is at minimum suggested.
With respect to claims 28-30 and 35, as above Perrut teaches PUFA (polyunsaturated fatty acids) and mixtures thereof.
With respect to claim 36, Perrut identifies EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) as useful PUFA products for isolation [Col. 1 lines 29-36].
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Perrut et al in view of Kessler et al, further in view of Tegen et al (US PGPub 2020/00255389 A1).
Perrut teaches as above but is silent to separation of cannabinoids from mixtures thereof.
However, Tegen teaches that cannabinoids represent a class of useful compounds for various potential medical applications but that they are difficult to separate because of the large number of species present in mixed form, and that chromatographic techniques are useful but that the previous state of the art involving non-continuous methods is difficult to scale and inefficient [0008], and suggests continuous chromatography methods for more efficient, scalable isolation of the desired species [0063].
It would have been obvious to one of ordinary skill in the art to employ the modified method of Perrut to mixtures of cannabinoids because, as in Tegen, continuous methods (such as Perrut’s) may be beneficial for efficiency and scalability and because as in Tegen, cannabinoids represent mixtures of compounds for which there are valuable, useful compounds viable for isolation via such chromatographic methods.
Claims 32-34 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Perrut et al in view of Kessler et al, further in view of Yamada et al (JP 2015-163607 A).
Perrut teaches as above, including isolation of PUFA species such as EPA as useful products. Perrut is silent to isolation of metabolites of such PUFA species, or to specific pre-resolving mediators such as 18-HEPE or the like.
However, Yamada teaches that while EPA can be a useful therapeutic agent which is readily available, but that metabolites thereof such as HEPE species have potential utility and at minimum research applications, and teaches isolating the HEPE from krill and shrimp using e.g. chromatographic methods in order to provide a lower cost source for research and use [Background Art; pg. 2, second paragraph]. Yamada further teaches that the metabolite species which may be isolated include 18-HEPE [pg. 2, first paragraph].
It would have been obvious to one of ordinary skill in the art to apply the modified method of Perrut to species such as 18-HEPE (which is both a metabolite and a pre-resolving mediator) in order to gain the benefit of providing a lower cost source of the species for research and/or use, as suggested by Yamada.
Claims 28-30, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et al in view of Perrut et al.
Kessler teaches as above but is silent to specific species being separated. However, as discussed above, Perrut teaches that PUSA species such as EPA or the like are useful products for chromatographic separations, including those that may involve recycling of raffinate fractions or the like. As such, employing the process of Kessler on these species would have been obvious, as Kessler is not particularly limiting in the specific applications and applying it to useful products would have been an obvious means of implementing the method in real world applications.
Claims 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et al in view of Tegen et al.
Kessler teaches as above but is silent to specific species being separated. However, as discussed above, Tegen teaches that cannabinoid species useful products for chromatographic separations, and which may have improved efficiency and scaling by employing continuous processes. As such, employing the process of Kessler on these species would have been obvious, as Kessler is not particularly limiting in the specific applications and applying it to useful products would have been an obvious means of implementing the method in real world applications.
Claims 28-30, 32-34, and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over Kessler et al in view of Yamada et al (or Kessler et al in view of Perrut et al, further in view of Yamada et al).
Kessler teaches as above but is silent to specific species being separated. However, as discussed above, Yamada teaches that metabolites such as 18-HEPE (which would also be a pre-resolving mediator) represent potentially useful species for separation via e.g. chromatographic methods, as an extension of previously known utility for their parent species such as EPA (which is itself discussed in Perrut, as above). As such, employing the process of Kessler on these species would have been obvious, as Kessler is not particularly limiting in the specific applications and applying it to useful products would have been an obvious means of implementing the method in real world applications.
Allowable Subject Matter
Claims 22, 23, 25, and 27 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is represented by Kessler and Perrut, discussed in the rejections above, which teach chromatographic separation processes in which at least some fractions are eluted or sent for further processing while others are recycled or otherwise returned to mix with feed, including provisions based on e.g. the purity or concentration of a target species in particular fractions. However, neither Perrut nor Kessler teach or fairly suggest controlling the flowrate of such recycle streams based on the concentration of the fraction or any other factor; similarly, neither Perrut nor Kessler teach or fairly suggest any direct comparison between the concentrations in the fractions and the concentrations of the starting feed material; instead, the indications are that recycling and other processing should be based on purity of a target product, or purity of a contaminant, or similar factors which are independent of the feed properties. The prior art as a whole does not cure these deficiencies and does not teach or fairly suggest flowrate optimization based on concentrations or any particular comparisons of feed and recycle concentrations or the like. As such, the inventions of claims 22, 23, 25, and 27 are free from the prior art.
Conclusion
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/BRADLEY R SPIES/Primary Examiner, Art Unit 1777