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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/07/2022 and 12/29/2022 are being considered by the examiner.
Claim Status
Applicants’ amendments and arguments filed 12/12/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims are 2-3 and 7-16 are canceled.
Claim 1 is amended.
Claims 1 and 4-6 are examined on the merits.
New Rejections Necessitated by Amendments
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 1 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 1 utilizing the term “and/or” which is unclear as to whether the claim requires all of the listed components (i.e. omega-3 or omega-6) or just one of the components individually or a combination of the components thereby rendering the claims indefinite.
Therefore, the Claim 1 will be broadly interpreted by the examiner to mean the claims require just one of the components individually (i.e. omega-3).
Claim 1 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 1 now recites “having a ratio of an amount of carboxylic acid functions to an amount of counter ions in a range of from 1 : 0.5 to 1 : 2 (carboxylic acid functions : counter ions) on a molar basis” which is unclear as to what a “carboxylic acid function” is. For example, is this omega-6 or is this a product of the process or is this an additional carboxylic acid or is this describing a function of the omega-6. Therefore, the claim is rendered indefinite.
For the purpose of moving prosecution forward, examiner broadly interprets this to mean a ratio of omega-3 or omega-6 to the counter ion.
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.
Claims 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Knaup et al (WO2016102316, published 06/30/2016, found in written opinion, hereafter Knaup), in view of Anwar et al. (Anwar, S. H., & Kunz, B. (2011). The influence of drying methods on the stabilization of fish oil microcapsules: Comparison of spray granulation, spray drying, and freeze drying. Journal of Food Engineering, 105(2), 367–378. https://doi.org/10.1016/j.jfoodeng.2011.02.047, hereafter Anwar).
Knaup teaches a process for increasing the stability of a composition comprising polyunsaturated omega-6 fatty acids (title; according to the claim limitations of the instant claim 1). Knaup teaches the process to be used for the manufacture of pharmaceutical products comprising polyunsaturated omega-6 fatty acids (page 12, lines 9-11; according to the claim limitations of the instant claim 1). Knaup teaches the steps of the process to include (i) providing a starting composition comprising at least one polyunsaturated omega-6 fatty acid component; (ii) providing a lysine composition; (iii) admixing aqueous, aqueous-alcoholic or alcoholic solutions of starting composition and lysine composition, and subjecting resulting admixture to spray drying conditions subsequently, thus forming a solid product composition comprising at least one salt of a cation derived from lysine with one anion derived from a polyunsaturated omega-6 fatty acid (claim 1; according to the claim limitations of the instant claims 1, 4, and 5). Additionally, Knaup states that combining can be achieved by any means allowing formation of product composition comprising at least one salt of a cation derived from lysine withy an anion derived from a polyunsaturated omega-6 fatty acid (page 8, line 40 – page 9, lines 1-2; according to the claim limitations of the instant claim 1). Claim 2 further teaches the process to have a ratio (R) of carboxylic acid (n(ca)) to lysine (n(lys) in which R = n(ca)/n(lys) and R is a range from 0.9-1.1 (according to the claim limitations of the instant claim 1). Knaup teaches omega-3 polyunsaturated fatty acids to be important polyunsaturated fatty acids along with omega-6 polyunsaturated fatty acids (page 2, lines 19-28; according to the claim limitations of the instant claim 1). Lastly, Knaup teaches one of the products from the process to be a food granulates (page 11, lines 38-40; according to the claim limitations of the instant claim 1).
Knaup teaches spray drying, however, Knaup fails to teach the process of spray granulation in a fluidized bed. Furthermore, Knaup fails to explicitly teach omega-3 in the process.
Anwar teaches the influence of drying methods on fish oil microcapsules, specifically a comparison of spray granulation, spray drying, and freeze drying (title; according to the claim limitations of the instant claim 1). Anwar teaches the components of fish oil to be eicosatetraenoic acid (EPA and docosahexaenoic acid (DHA) then further labels the fish oil as omega-3 fish oil (abstract; according to the claim limitations of the instant claim 1). Furthermore, Anwar teaches spray granulation used for the comparison included a suspension in a fluidized gas (page 368, paragraph 2.2 spray granulation; according to the claim limitations of the instant claim 1). Anwar outlines that microencapsulation then drying of omega-3 fish oil by spray granulation (SG) is able to produce powder having a very low propanal content and with a shelf life of 5 weeks (abstract; according to the claim limitations of the instant claim 1). Anwar further outlines that spray granulation is proved to be the best drying process to produce stable microcapsules (page 377, paragraph 2; according to the claim limitations of the instant claim 1). Anwar teaches the spray granulation results provided a lower chance of lipid degradation by autooxidation than spray drying (SD -abbreviation found in abstract) (page 377, paragraph 2; according to the claim limitations of the instant claim 1). Lastly, Anwar teaches the granulation obtains a granule size of 350-650 µm (page 369, paragraph 1; according to the claim limitations of the instant claim 1).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention would modify the process for increasing the stability of a composition comprising a polyunsaturated fatty acid salt, in which the formation of the product can be achieved by any means of combining, as claimed by Knaup by the method of using spray granulation in a fluidized suspension to produce a granule with a size of 350-650µm as outlined by Anwar under TSM, see MPEP 2143(G). As outlined by Anwar, using the process of spray granulation in a fluidized suspension produces a stable omega-3 granule at a size of 350-650µm with a lower chance of lipid degradation then spray drying which would motivate someone skilled in the art to advantageously add the process of spray granulation in a fluidized bed to the process of Knaup as it would have a reasonable expectation of success. Therefore, the process of granulation as claimed by instant claim 1 and dependent claims 4 and 5 would be of obviousness. Furthermore, it is necessarily the case that granules, having the same components and particle size, would necessarily exhibit the same particle size distribution curve absent evidence to the contrary (In re Best). It would be obvious for one skilled in the art to claim the simple substitution of omega-3 for the omega-6 in the process outlined by Knaup as Knaup lists them to both be important polyunsaturated fatty acids. Simple substitution of one polyunsaturated fatty acid for another is within the purview of the skilled artisan and would yield predictable results. Knaup claims a ratio range of carboxylic acid to lysine that lies within the range disclosed by instant claim 1 thus making it of obviousness. In regards to instant claim 3, Anwar teaches the method of granulation to be continuous granulation thus making it obvious to claim. In regards to claim 6, Anwar teaches the omega-3 to be obtained from fish oil thus making it obvious to claim.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Knaup et al (WO2016102316, published 06/30/2016, found in written opinion, hereafter Knaup), in view of Anwar et al. (Anwar, S. H., & Kunz, B. (2011). The influence of drying methods on the stabilization of fish oil microcapsules: Comparison of spray granulation, spray drying, and freeze drying. Journal of Food Engineering, 105(2), 367–378. https://doi.org/10.1016/j.jfoodeng.2011.02.047, hereafter Anwar), and in view of NIH (National Institutes of Health. (2016, December 8). Office of dietary supplements - omega-3 fatty acids. Omega-3 Fatty Acids, Fact Sheet for Health Professionals. https://web.archive.org/web/20161208022445/https://ods.od.nih.gov/factsheets/Omega3FattyAcids-HealthProfessional/, via the wayback machine, hereafter NIH).
As mentioned above, Knaup in view of Anwar teaches a process for granulating a polyunsaturated fatty acid salt with the steps disclosed by instant claim 1.
Knaup fails to teach a fatty acid sources as in instant claim 6. Anwar fails to teach fatty acid sources other than fish oil as in claim 6.
NIH teaches omega-3 fatty acids to be present in flaxseed oil, soybean oil, canola oil, fish oil, and krill oil (page 2, first paragraph). Furthermore, NIH teaches omega-3 to be present in some vegetation products that contain algal oil (page 4, dietary supplements). Lastly, NIH teaches omega-3 to be present in flaxseed oil also known as linseed oil (page 3, sources of Omega-3s, food).
One skilled in the art before the effective filing date of the claimed invention would claim a process for granulating a polyunsaturated fatty acid outlined by Kraup in view of Anwar with the ready for improvement with the known technique of deriving omega-3 fatty acid from krill oil, linseed oil, algal oil, flaxseed oil, canola oil, and soybean oil as outlined by NIH. Deriving omega-3 fatty acid from oils known to contain omega-3 fatty acid as claimed by instant claim 6 would yield predictable results thus making them of obviousness as modification of a known process with a known technique is within the purview of the skilled artisan.
Response to Applicant’s Argument
Applicant’s arguments filed on 12/12/2025 have been considered by the Examiner.
In regards to the 35 USC § 103 rejections of record, Applicant first argues that the added physical properties to the amended instant claim 1 are not recited in the prior art. Furthermore, Applicant refers to multiple comparative examples from the instant specification, focusing on Example 10 from page 19 which compares example 2 with comparative example C-4. Applicant argues that this data demonstrates that spray granulating an admixture in a fluidized bed produces a product having different features.
In response to Applicant’s arguments that the prior art does not teach the physical properties of the product produced by the claimed process, Applicant is reminded that product is not separable from its physical properties. As outlined in the claim interpretation above and reiterated here, the instant claims are a process and product by process and the prior art teaches the claimed process and product thereby since a product is not separable from its physical properties then it necessarily teaches the properties A-D claimed in instant claim 1. Applicants observation that it also has a ‘A. D90 between 350 µm and 1500 µm’ or the remaining properties B-D, does not give it patentable weight, since it is the same composition and same process of making, as adding a characterization to a prior art patented invention is not patentable.
In response to Applicant’s argument utilizing the data from the instant specification, it is noted that the comparative example and the example 2 have different process parameters and tablet properties. For instance, in Table 3 on page 14, it is shown that example C-4 has the process parameters of 68oC average bed temperature, 1 bar atomization air pressure, and a process factor of 1.47, while in contrast the example 2 found in Table 5 of page 15, has an average bed temperature of 64oC, a atomization pressure of 0.6 bar, and a process factor of 1.85. Therefore, it is unclear if the difference in workability is due to the type of granulation or the process parameters themselves. Furthermore, it is noted that the examples C-4 and 2, have different overall properties such as hardness which may be due to the process parameters and result in the variation in workability. Furthermore, it is noted that the limitations of average bed temperature, air pressure, or workability in a tableting machine are not in the instant claims. Therefore, the claims are not commensurate with the data presented from the instant specification. Therefore, Applicant has failed to outline why one skilled in the art would not be motivated to use spray granulation. As outlined in the 35 USC § 103 rejection above, spray granulation in a fluidized suspension produces a stable omega-3 granule with a lower chance of lipid degradation then spray drying which would motivate someone skilled in the art to advantageous utilize spray granulation in a fluidized bed. Applicant is reminded, that the MPEP 2111.03(III) states “applicant has the burden of showing that the introduction of additional steps or specific components which would materially change the characteristics of the claimed invention.” In summary, Applicants have failed to properly demonstrate how and which additional components materially affect the basic and novel characteristics of the claimed process.
In summary, Examiner is not persuaded by Applicant’s arguments. The 35 USC § 103 rejections of record are updated to account for claim amendments.
Conclusion
No claims allowed.
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/A.N.I./Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611