DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the
Status of the Claims
Claims 1, 6, 8, 18, 20, 26, 29, 31, 80-82, and 84-92 are pending, presented for examination, and rejected as set forth below.
Claim Interpretation
Applicants claims are directed towards methods of producing powdered compositions of encapsulated bioactive exogenous oil, whereby an aqueous composition of protein and carbohydrate is obtained from a single species of pretreated biomass, specifically Brassica oleracea, exogenous oil as the bioactive is added to that mixture, an emulsion is formed from the mixture containing the bioactive, and producing a powder from this emulsion that has an induction period of at least about 42 hours when measured under certain accelerated conditions of oxidation. The examiner notes this language effectively provides a quantification of the resistance to oxidation the powder is to possess. See P. Simon, et al, Analysis of the Induction Period of Oxidation of Edible Oils by Differential Scanning Calorimetery, 77 JAOCS 639 (2000), see also Specification pg.12. Therefore, art which explains the need or desire to extend oxidative stability of powders obtained from processing biomass emulsions will be considered sufficient to address the newly added limitations concerning induction period measured under particular parameters. The U.S. Patent office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Dependent claims place further alternative limitations on, for example, the oil content of the emulsion prior to powder formation, the protein to carbohydrate ratio of the biomass, the source of the bioactive and/or bioactive precursor, processing steps used to pretreat the biomass, narrowing the identity of the biomass to be used in the process, the oil to be used, the nature of the post-emulsification treatment, and the inclusion of either an isothiocyanate or glucoraphanin from the biomass. The examiner reminds applicants that dependent claims necessarily refer back to and incorporate all of the limitations of the claims from which they depend. 37 C.F.R. 1.75(c). As such, any biomass recited by dependent claims as satisfying the requirements of Claim 1 will be presumed to possess the properties applicants have recited in Claim 1. Additional dependent claims narrow the oxidative stability parameters, oil content or oil source, and/or identity of the particular isothiocyanate or precursor to be present in the composition.
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 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, 6, 8, 20, 26, 31, 80-82, and 84-92 are rejected under 35 U.S.C. 103 as being unpatentable over Fichtali (U.S. PGPub. 2006/0286205) in view of Diehl (WO2018/122057), Ragasa (Consolacion Y. Ragasa, et al, Sterols, Triglycerides and Essential Fatty Acid Constituents of Brassica oleracea varieties, Brassica juncea and Raphanus sativus, 5 J Chem. Pharma. Res. 1237 (2013)), and Gurin (CA3119621).
Fichtali describes methods of forming biomass emulsions to encapsulate active agents such as polyunsaturated fatty acids. (Abs., [0054]). Fichtali indicates that these methods include hydrolyzing a biomass and emulsifying the biomass to for a stable product. [0015]. Fichtali states that the emulsified biomass may be further processed to provide a dried powder by employing, among others, the spray drying step of Claim 31. [0016; 0030]. Fichtali indicates that the hydrolyzing step to provide the biomass for emulsification may include the enzymatic treatment of the biomass, addressing Claim 18, and may further be modified to permit the incorporation of additional components including, but not limited to, antioxidants. [0018; 0031; 0066-67]. The biomass to be treated may be selected from any of a variety of sources, including but not limited to plants such as mustards. [0025-26; 0055]. Fichtali describes the DHA of each of Claims 26, 80, and 81 as a particularly preferred nutrient for encapsulation by this method, [0028; 0056], which may be added to the compositions when the biomass is lacking in them, addressing the “exogenous” identity of the bioactive to be used of Claim 1. [0067]. Indeed, Fichtali specifically directs the skilled artisan to understand that ingredients to enhance the product quality, appearance, sensory and nutritional value of the compositions may be added, including each of proteins and carbohydrates from additional or alternative biomass sources to provide a desired protein/carbohydrate profile falls within the teachings of the disclosure. [0066]. This establishes not only the desirability of incorporating protein and carbohydrate sources from a second biomass, but also establishes that the amounts of each are variables suitable for optimization by the skilled artisan. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.). An exemplary embodiment of enriched composition contains 25.01% protein to 39.09% carbohydrate, a ratio of 1:1.56, overlapping and therefore rendering obvious the limitations of Claim 6. [0107], See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Fichtali indicates that oils, including essential fatty acids, may be either present in the biomass or incorporated into the emulsion to enrich or alter the composition of the final products obtained, addressing the language concerning the exogenous source of the bioactive containing oil of Claim 1. [0055-56; 0067]. While Fichtali does not specify, for example, the oil content of the emulsion prior to drying as is recited by Claims 2 and 86-88, Fichtali does indicate that the amount of oil present in the emulsion determines whether the emulsion is water-in-oil (between 80-90% oil), or oil-in-water (containing between 30-99% water, with the balance either oil or solids). [0054]. A person of ordinary skill in the art would reasonably have expected that the amounts of oils present in the emulsion prior to drying are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Fichtali to arrive at the oil concentrations recited by Claims 2 and 86-88. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.).
The specific combination of features claimed is disclosed within the broad generic ranges taught by the reference but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of combining a DHA containing plant biomass with water to provide an aqueous mixture for enzymatic treatment, then emulsification with defined quantities of oils to provide an emulsion for subsequent drying, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of combining a plant biomass with water to provide an aqueous mixture for enzymatic treatment, then emulsification with defined quantities of oils to provide an emulsion for subsequent drying from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Despite this, Fichtali does not specify that the instantly claimed Brassica oleracea or its varieties botrytis or italica may serve as the biomass or that isothiocyanates such as sulforaphane may be incorporated.
This is cured by the teachings of Diehl, which indicates that Brassica species are an excellent plant biomass source useful in methods of obtaining PUFA from lipid containing biomasses. (Pg.15). The skilled artisan’s knowledge on this front is further augmented by the teachings of Ragasa, which establishes that the presently claimed species of Brassica, specifically the oleracea varieties italica and botrytis, are rich not only in the PUFA which both Diehl and Fichtali seek to obtain, but which also provide a variety of additionally beneficial compounds of nutraceutical interest including isothiocyanates such as the presently claimed sulforaphane. (Pg.1237-38). Further adding to the skilled artisan’s knowledge are the teachings of Gurin, which establishes that omega-3 fatty acids including the DHA advocated by Fichtali as an exemplary exogenous oil to be added to the biomass during the powder production process provide a variety of health-inducing characteristics. [002; 004; 009-011; 013-17]. Gurin indicates that fish and marine oils of Claims 91 and 92 are a known and excellent source of these fatty acids. [028]. Gurin goes further, indicating that particularly advantageously additives to improve oxidation resistance and stability are to be combined with the omega-3 fatty acids in the nutritional compositions described. Pg.4. Gurin describes the presently claimed bioactive isothiocyanate sulforaphane as a particularly useful antioxidant used to protect the fatty acids from oxidation. [044-45].
Owing to the fact that the presently claimed Brassica oleracea varieties botrytis or italica were known to be rich in sulforaphane as well as the PUFA which each of Diehl and Fichtali seek to obtain from plant biomass, and that combinations of sulforaphane and omega-3 fatty acids including the presently claimed DHA are known to increase oxidation resistance of the compositions containing them, it would have been prima facie obvious to have selected biomass from Brassica oleracea varieties botrytis or italica as the starting biomass for the process of Fichtali describing the presently claimed process of obtaining an aqueous biomass mixture, adding oil which combines DHA and sulforaphane, forming an emulsion, and then from that emulsion forming a powder containing the desired encapsulated biomass extracts with the expectation that such a combination would provide.
Claims 1, 6, 8, 18, 20, 26, 29, 31, 80-82, and 84-92 are rejected under 35 U.S.C. 103 as being unpatentable over Fichtali, Diehl, Ragasa, and Gurin as applied to Claims 1, 6, 8, 20, 26, 31, 80-82, and 84-92 above, and further in view of Augustin (U.S. 7,374,788).
Fichtali, Gurin, Diehl, and Ragasa, discussed in greater detail above, suggest processes of obtaining powdered encapsulated nutrients such as sulforaphane including combinations of biomass-derived proteins and carbohydrates and Brassica oleracea varieties botrytis or italica biomass-derived PUFAS including DHA by combining a plant biomass with water to provide an aqueous mixture for enzymatic treatment, then emulsification with defined quantities of oils containing combinations of DHA and sulforaphane to provide an emulsion for subsequent drying.
However, neither Fichtali, Gurin, Diehl, nor Ragasa describe a step whereby the emulsion or suspension is pre-treated by being heated.
This is addressed by the teachings of Augustin, which indicates that the spray-drying processes described by Fichtali as the means of obtaining the powder from the emulsions formed are known to include steps whereby emulsions encapsulating polyunsaturated fatty acids are spray-dried by preheating an emulsion to 60C, then passing the preheated emulsion through an atomizer whereby the inlet and outlet air temperatures are 180C and 80C, respectively. (Col.4, L.59-64).
It would have been prima facie obvious for one having ordinary skill in the art to have heated the emulsions during the process of spray drying a polyunsaturated fatty acid emulsion according to the teachings of Fichtali. This is because Fichtali describes spray-drying as a means of obtaining the encapsulated powders described, and Augustin describes spray-drying processes for obtaining powdered PUFA emulsions which incorporate post-treatment heating per the requirements of Claim 29. The heating step claimed therefore appears to be little more than the predictable use of prior art elements according to their established functions, and obvious as a result. KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)).
Response to Arguments
Applicant's arguments filed 22 October 2025 have been fully considered but they are not persuasive.
Applicants arguments concerning the “focus” of Fichtali being the processing of organisms for the purpose of preserving and making digestible endogenous nutrients in a biomass, and that high levels of PUFA are present in such a biomass making the addition of exogenous oils is unpersuasive. This is because the reason or motivation to modify a prior art reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). Where, as here, the process steps, including the enzymatic hydrolysis pretreatment step recited by Claim 18, are taught by the art, nothing more is required. Similarly, while the addition of exogenous oils may not be required per the teachings of Fichtali, it nevertheless remains an alternative embodiment of the invention described. The Fichtali disclosure explains that additional oils, and additional PUFAs, may be combined with the biomass during processing, rendering the addition of such oils prima facie obvious.
Applicants repeated argument concerning the exemplified embodiments of Fichtali employing single-celled organisms as the biomass is no more persuasive upon its repetition. This is because while certain exemplified embodiments may utilize such single-celled organisms, the entirety of the disclosure is not so limited. Applicants are reminded that art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). Because Fichtali additionally describes using multicellular organisms such as plants as alternative sources of biomass, the fact that the exemplified embodiments are single-celled organisms is irrelevant. Applicants arguments concerning the absence of guidance to the selection of Brassica oleracea as a suitable biomass is unpersuasive for similar reasons: Fichtali enumerates plants as a suitable biomass for processing, and the art via the teachings of Diehl and Ragasa provides additional support for the skilled artisan’s selection of Brassica oleracea as just such a biomass.
Applicants assertion that Fichtali provides no guidance as to what additional oils may be incorporated is unpersuasive. Applicants are reminded that it is not possible to establish the non-obviousness of an invention rendered obvious by the combined teachings of multiple prior art references by arguing that each of the references relied upon fails to teach the entirety of the invention which has been claimed; the absence of a single anticipatory reference is implied by both the reliance on the combined teachings of multiple references as well as the fact that the rejection being made is one of obviousness under 35 U.S.C. 103 rather than any of the subsections of 35 U.S.C. 102. MPEP § 2145(IV), see In re Keller, 642 F.2d 413, 426 (C.C.P.A. 1981) (citing Application of Young, 403 F.2d 754, 757 (C.C.P.A. 1968) (indicating that "[O]ne cannot show non-obviousness by attacking references individually where ... the rejections are based on combinations of references"). Here, the teachings of Fichtali concerning the inclusion of additional exogenous oils simply opens the door to the consideration of additional art known to the skilled artisan, namely the teachings of Diehl, Ragasa, and Gurin, which provides, as explained previously and again above, numerous health benefits associated with incorporating fish and marine oils rich in omega-3 fatty acids such as DHA into nutritional compositions such as those of Fichtali.
Applicants assertion that the Examiner’s description of the teachings of Diehl “overexaggerates” the information conveyed therein is also unpersuasive. Diehl particularly exemplifies Brassica oleracea as a particularly preferred and explicitly recited embodiment of biomass used to obtain PUFA. The Examiner stands by their choice of synonymous verbiage, notwithstanding Diehl’s indication that an alternative may be even more superior. In re Gurley, 27 F.3d 551, 554 (Fed. Cir. 1994).
Applicants arguments concerning the examiner’s reliance on Ragasa are unpersuasive for the reasons set forth previously and above concerning the PUFA and antioxidant content of Brassica oleracea aligning with the PUFA and antioxidant requirements of Fichtali.
Applicants arguments concerning the teachings of Gurin and Augustin are also unpersuasive as the examiner has not relied on Gurin or Augustin to establish any of the deficiencies applicants allege are present in the Gurin or Augustin disclosures viewed in a vacuum. See Keller, supra; see also In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[T]he Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.”).
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
THIS ACTION IS MADE FINAL. 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614