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 .
Priority
This application, filed on 10/19/2020, claims priority from EP18169368.0 filed on 04/25/2018, EP18179081.7 filed on 06/21/2018, and PCT/EP2018/086369 filed on 12/20/2018.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 02/22/2021, 03/09/2022, 03/09/2022, 10/21/2022, 01/30/2023, 02/07/2023, 06/26/2023, 09/27/2023, 12/15/2023, 06/10/2024 and 07/17/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
DETAILED ACTION
The Amendments and Applicant’s Arguments submitted on 06/16/2025 have been received and have been carefully considered.
Claims 15 was amended, claims 6-8 were previously canceled, and Claims 20-22 were added. Claims 1-5 and 9-22 are pending.
Rejections- Maintained/Modified/Added in view of the amendment
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.
Claims 1-5 and 9-22 are rejected under 35 U.S.C. 103 as being unpatentable over J. Petrie et al. (US PG-PUB 2013/0338387 A1, 12/19/2013, “Petrie” cited in the previous PTO-892 dated 09/19/2023).
Petrie teaches plant extracted lipid compositions, comprising fatty acids in an esterified form, the fatty acids comprising, docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), α-linolenic acid (ALA), oleic acid, and palmitic acid, [Petrie, pg. 2, 0015], wherein the plant lipid comprises:
docosahexaenoic acid (DHA) in an amount of about 7% to 20% of the total fatty acid content of the extracted lipid; [Petrie, pg. 2, 0015].
eicosapentaenoic acid (EPA) in an amount of between about 0.05% and about 10%, and between about 0.05% and about 2% of the total fatty acid content of the extracted lipid; [Petrie, pg. 3, 0026].
α-linolenic acid (ALA) in an amount of between about 10% and about 35%, between about 20% and about 35%, or between about 4% and about 16% of the total fatty acid content of the extracted lipid; [Petrie, pg. 2, 0021].
oleic acid in an amount of between about 6% and about 30%, between 1% and about 20% or between about 30% and about 60% of the total fatty acid content of the extracted lipid; [Petrie, pg. 2, 0019].
palmitic acid in an amount of about between about 2% and 15%, of the total fatty acid content of the extracted lipid. [Petrie, pg. 2, 0017].
eicosatetraenoic acid (ETA) (20:4n-3) in an amount of less than about 4%, or between about 0.05% and about 2%. [Petrie, pg. 2, 0024].
Petrie teaches the lipids are provided in the form of fatty acid ethyl esters, [Petrie, pg. 4, 0059]. Petrie teaches a process for producing ethyl esters of the fatty acids. [Petrie, pg. 10, 0224].
Petrie teaches that the term “about”, refers to +/−10%, more preferably +/−5%, more preferably +/−1% of the designated value. [Petrie, pg. 18, 0461]. As such, the Petrie “about” 2% palmitic acid is equivalent to 1.8% (-10% of 2%). Moreover, Petrie teaches that the amounts of fatty acids can be altered by about 10% alteration. [Petrie, pg. 19, 0463], and therefore, Petrie’s palmitic acid amount can be equivalent to 1.6%.
While Petrie teaches a lipid composition comprising DHA in an amount of about 7% to 20%, EPA in an amount of about 0.05% or about 2%, α-linolenic acid in an amount of about 10-35%, 20-35%, or 4-16%, oleic acid in an amount of about 1-20%, or 30-60%, palmitic acid in an amount of about 2-15%, of the total fatty acid content of the extracted lipid, Petrie does not teach that the amount of DHA is from about 15% to about 35%; EPA up to about 5%; α-linolenic acid from about 10% to about 20%; oleic acid from about 20% to about 40%, and palmitic acid up to about 1.5% by weight of the total fatty acid content.
The claimed lipid composition comprising DHA, EPA, α-linolenic acid, oleic acid, and palmitic acid is prima facie obvious over Petrie lipid composition because Petrie’s lipid composition comprising DHA, EPA, α-linolenic acid, oleic acid and palmitic acid in an overlapping or encompassing ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). Moreover, "[A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Furthermore, "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
As provided in MPEP 2144.05 I, Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). See also Warner-Jenkinson Co., Inc. v. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%); In re Scherl, 156 F.2d 72, 74-75, 70 USPQ 204, 205-206 (CCPA 1946) (prior art showed an angle in a groove of up to 90° and an applicant claimed an angle of no less than 120°); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Dreyfus, 73 F.2d 931, 934, 24 USPQ 52, 55 (CCPA 1934)(the prior art, which taught about 0.7:1 of alkali to water, renders unpatentable a claim that increased the proportion to at least 1:1 because there was no showing that the claimed proportions were critical); In re Lilienfeld, 67 F.2d 920, 924, 20 USPQ 53, 57 (CCPA 1933)(the prior art teaching an alkali cellulose containing minimal amounts of water, found by the Examiner to be in the 5-8% range, the claims sought to be patented were to an alkali cellulose with varying higher ranges of water (e.g., "not substantially less than 13%," "not substantially below 17%," and "between about 13[%] and 20%"); K-Swiss Inc. v. Glide N Lock GmbH, 567 Fed. App'x 906 (Fed. Cir. 2014)(reversing the Board's decision, in an appeal of an inter partes reexamination proceeding, that certain claims were not prima facie obvious due to non-overlapping ranges); In re Brandt, 886 F.3d 1171, 1177, 126 USPQ2d 1079, 1082 (Fed. Cir. 2018)(the court found a prima facie case of obviousness had been made in a predictable art wherein the claimed range of "less than 6 pounds per cubic feet" and the prior art range of "between 6 lbs./ft3 and 25 lbs./ft3" were so mathematically close that the difference between the claimed ranges was virtually negligible absent any showing of unexpected results or criticality.).
With respect to the claim 1 amendment, “wherein said vegetable-based composition is more stable to oxidation than a similar animal-based lipid composition comprising the same amount of DHA”: claim 1 is drawn to a vegetable-based lipid composition comprising DHA in an amount of about 15-35%; EPA up to about 5%; α-linolenic acid from about 10-20%; oleic acid from about 20-40%, and palmitic acid up of about 1.0% by weight of the total fatty acid content. It is recognized that the prior art of Petrie teaches substantially identical components of the claimed composition in similar or overlapping amounts as described above. As such, it is reasonable to infer that the prior art composition will also have more stability to oxidation as the claimed vegetable-based composition both of which are more stable than a similar animal-based lipid composition. Applicants are reminded that the office does not have the facilities and resources to determine the stability to oxidation. In the absence of evidence to the contrary, the burden is on applicants to show that this property is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
Therefore, Petrie reads on claims 1-5 and 22.
With regard to the amount of docosahexaenoic acid of claims 15, 18, and 20, Petrie teaches that the term “about”, refers to +/−10%, thus, the amount of 20% is equivalent to 22%. Petrie teaches a method of manufacturing the fatty acid composition comprising purification, transesterification and fractionation of the oils, wherein the method include treatment with ethyl esters and distillation. The method comprises firstly purifying the oil and/or transesterification, and/or fractionation of the oil to increase the level of DHA. In a particular embodiment, the method comprises treating the lipid or oil such as canola oil to convert the fatty acids in the oil to alkyl esters such as methyl or ethyl esters. Further treatment such as fractionation or distillation is applied to enrich the lipid or oil for the DHA. In a preferred embodiment, the medicament comprises ethyl esters of DHA. [Petrie, pg. 15, 0349]. Petrie further describes the transesterification process wherein after ethyl transesterification, the fatty acid fractionation to increase the concentration of PUFA in an oil can be achieved by any of the methods known in the art, such as, molecular distillation. [Petrie, pg. 36, 0609]. Note that instant specification recites molecular distillation as species of the distillation processes. [Instant specification, pg. 15, ln. 25].
With regard to the amount of docosahexaenoic acid of claims 19 and 21, Petrie amount of docosahexaenoic acid 20% meets the claimed amount of about 25% because about 25% is equivalent to 20%. Note that Petrie teaches that the amounts of fatty acids can be altered by about 10% alteration. [Petrie, pg. 19, 0463]
With regard to claims 9, 10, and 11, Petrie teaches that the lipid is an oil from an oilseed (plant) includes Brassica sp., Gossypium hirsutlum, Linum usitatissimum, Helianthus sp., Carthamus tinctorius, Glycine max, Zea mays, Arabidopsis thaliana, Sorghum bicolor, Sorghum vulgare, Avena sativa, Trifolium sp., Elaesis guineenis, Nicotiana benthamiana, Hordeum vulgare, Lupinus angustifolius, Oryza sativa, Oryza glaberrima, Camelina sativa, Crambe abyssinica, Miscanthus ×giganteus, or Miscanthus sinensis. [Petrie, pg. 5, 0067].
With regard to claims 12 and 13, Petrie teaches that the lipid composition is in the form of a tablet, capsule, ingestible liquid or powder, injectable, or topical ointment or cream, wherein the composition comprises antioxidant, surfactants, emulsifiers, and stabilizers (agar-agar, lactose, gelatin, etc.). [Petrie, pg. 37, 0622, 0624].
With regard to claim 14, Petrie teaches a method of treating or preventing a condition which would benefit from a poly unsaturated fatty acid (PUFA) comprising administering the lipid composition, [Petrie, pg. 15, 0347], wherein the condition which would benefit from a PUFA include cardiac arrhythmia's, coronary heart disease, hypertension, high blood pressure, etc. [Petrie, pg. 15, 0348]. While claim 14 appears to be an intended use of the lipid composition, the prior art of Petrie is capable of treating the claimed diseases and conditions. See, MPEP 2111.02; e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963).
With regard to claim 16, Petrie teaches that the plant is genetically constructed and the oilseed plant is transgenic, [Petrie, pg. 15, 0349], wherein “transgenic plant”, “genetically modified plant” or variations thereof refers to a plant that contains a gene construct (“transgene”) not found in a wild-type plant of the same species. [[Petrie, pg. 15, 0349].
With regard to claim 17, Petrie teaches that the Brassica species is Brassica napus or Brassica juncea. [Petrie, pg. 31, 0558].
Response to Arguments
Applicant argues:
The examiner’s interpretation of “about” in Petrie is unsupported.
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive. Petrie explicitly teaches “as used herein, the term “about”, unless stated to the contrary, refers to +/−10% of the designated value, [Pg. 18, [0461]]. This teaching indicates that any amount can be considered within +/- 10%. Moreover, Petrie teaches that “the ratio of one or more or all of, oleic acid to DHA, palmitic acid to DHA, linoleic acid to DHA, and total ω6 fatty acids: total ω3 fatty acids, has not been significantly altered (for example, no greater than a 10% or 5% alteration), [Pg. 18, [0463]], which opens room for further alteration in the amount of fatty acids by 10% or 5%. Therefore, the interpretation of “about” is clearly recited in Petrie, and the further alteration in the amount of the fatty acids is also clearly recited in Petrie. Therefore, one of ordinary skill in the art would reasonably read an amount of about 20% taught by Petrie as 22% (20 x +10/100 = 22%), and with the possibility of alteration of 10%, the amount of about 20% would be equal to 19.8 or 24.2 (22 x +/-10/100). Thus, the examiner interpretation to Petrie’s term “about” is according to Petrie’s explicit teachings.
Applicant argues:
Even if one skilled in the art would read Petrie to mean that about 2% palmitic acid encompasses 1.8% to 2.2%, there is nothing in Petrie to suggest that one skilled in the art would interpret 2%-12% palmitic acid to mean 1.6%. Even if there were any factual basis for that interpretation, which there is not, there is no evidence in Petrie that supports the assertion that 1.6% equals “no more than 1.0%” as recited by the claims. claim 19 does not recite “about 25%.” Second, there is nothing in Petrie that teaches or suggests that 20% is equal to about 25%, much less 25%. [Remarks, pg. 2 last para. - pg. 3, 2nd para.].
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive. Petrie teaches a lipid composition comprising about 7% to 20%, EPA in an amount of about 0.05% or about 2%, α-linolenic acid in an amount of about 10-35%, 20-35%, or 4-16%, oleic acid in an amount of about 1-20%, or 30-60%, palmitic acid in an amount of about 2-15%, of the total fatty acid content of the extracted lipid, which are overlapping, encompassing or merely close to the claimed ranges/amounts, see MPEP 2144.05 I was discussed above (Prima facie obviousness established above). The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05. As such, an artisan having ordinary skill in the art would have been motivated to modify the amounts of palmitic acid of 1.6% to achieve 1.0%. As provided in the MPEP 2144.05.II.A “generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Applicant does not show that the amount of palmitic acid of 1.0% is critical, or provide factual supportive evidences that the claimed amount provides unexpected benefit, or provide evidences that the claimed amount show superiority over the prior art amount.
Applicant argues:
Moreover, the Examiner is engaging in hindsight in cherry-picking from among the vast ranges of individual fatty acid components referred to in Petrie, without addressing the claim as a whole. The weight ranges relied on by the Examiner only partially overlap with the present claims, and there is no teaching or suggestion in Petrie to any lipid composition that would fall within claim 1 when taken as a whole. Petrie does not provide any motivation to choose from the vast ranges referenced in Petrie to arrive at the claim as a whole. (ranges so broad they do not suggest the specific limitations to one of ordinary skill in the art at the time the invention was made). The Examiner has provided no motivation why one skilled in the art at the time the Application was filed would simultaneously select from the myriads of possible combinations to arrive at the claimed composition. Only hindsight would lead to the Examiner’s conclusion regarding Petrie. [Remarks, pg. 3, 3rd para. – pg. 4, 2nd para.].
Examiner response:
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As provided in MPEP 2144 (IV). the reason or motivation to modify the 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); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) ("One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings."); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). In the instant case, the instant claims and the prior art are directed to preparing a lipid composition comprises fatty acids in amounts overlapping, encompassing, or close to the claimed amount. One of ordinary skill in the art would have been motivated with reasonable expectation of success to choose the amount of DHA, EPA, a-linolenic acid, oleic acid, palmitic acid and eicosatetraeniaic acid taught by Petrie. The instant claims recite a lipid composition comprising fatty acids. “comprising”, an open-ended transitional phrase that does not exclude other unrecited elements, thus, the list of Petrie reads on the claimed composition. The claims are directed to a lipid composition comprises fatty acids in ranges, there is specific composition with specific amount and there is no criticality to these amounts. For example, the claimed amount of oleic acid of 20-40% is met by Petrie teachings of: oleic acid in an amount of between about 30% and about 60% of the total fatty acid content of the extracted lipid [Petrie, pg. 2, 0019], which overlapped and falls merely close to the claimed amount (taking into account the definition of about, and the possibility of alteration taught by Petrie, see above). The amount of oleic acid of Petrie renders the claimed amount of oleic acid obvious in view of the above analysis, MPEP 2144.05 I.
Applicant argues:
Petrie refers to broad ranges of possible components, with no composition that possesses the components of claimed composition. There is also no teaching or suggestion in Petrie that a vegetable-based composition would be more stable than an animal-based composition. The Examiner asserted that the burden is on applicants to show this property is different from those of the prior art, but the Examiner has not shown where the prior art says anything about this property. Petrie refers to lipids extracted from a variety of plants, so to the extent there is relevance to the applicant’s starting materials, the applicant started with a lipid extract (DHA Canola Oil). When applicants compared the stability of the vegetable- based oil (DHA Canola oil) and the animal-based Reference oil, using a standard Rancimat stability study in Example 4, the results showed that the vegetable-based oil was less oxidatively stable than the animal-based oil comparator. See specification at [0113]. Accordingly, there is nothing in Petrie to teach or suggest that the extracted lipid of Petrie would have more stability to oxidation than an animal-based composition, and indeed the applicants have shown the contrary. If the Examiner’s assertion that the applicants’ composition is similar to the composition of Petrie were correct (which it is not), that composition would have less stability than the animal comparator, not more. Surprisingly, only when the applicants modified the extracted lipid to arrive at the claimed composition did the oxidative stability become superior to that of the animal comparator. See specification at Examples 11 and 20, [0154], [0189]. Petrie does not teach or suggest any method of testing the stability of oils referenced therein, nor that vegetable-based compositions are more stable than animal-based compositions after enrichment, nor that modifying extracted lipid per the claimed composition would result in any change in oxidative stability relative to an animal-based composition, nor any expectation of success in the claimed result. The evidence of the patentable distinction of the claimed composition is provided in the instant application. The Examiner is in error in applying inherency to the functional aspects of the claim over Petrie given these facts. [Remarks, pg. 4, last para. -pg. 6, 1st para.].
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive. Applicant discusses unexpected results by showing superiority of the claimed vegetable-based fatty acid composition over the animal-based fatty acid composition. However, the prior art fatty acid composition is plant-based composition as well. If the vegetable-based composition is more stable than the animal-based composition, one of ordinary skill in the art would also expect that Petrie’s composition would be more stable than the animal based fatty acid composition because of the similarity of Petrie’s vegetable oil compositions to the claimed composition. As explained above, because the prior art of Petrie teaches substantially identical components of the claimed composition in similar or overlapping amounts, it is reasonable to infer that the prior art composition would also have more stability to oxidation as the claimed vegetable-based composition both of which are more stable than a similar animal-based lipid composition. Applicants are reminded that the office does not have the facilities and resources to determine the stability to oxidation. In the absence of evidence to the contrary, the burden is on applicants to show that this property is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989). Moreover, as provided in MPEP 716 (d), “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In the instant case, the asserted unexpected results discussed in Example 4 include comparison between canola oil and reference oil when canola oil show poor stability compared to the reference oil, however, the reference oil (Examples 1 and 2), is not commensurate in the scope of the claim. The claims are directed to specific amount of specific fatty acid, however, there is no recitation of the types of fatty acid in the reference oil let alone the amount of these fatty acid. Thus, the asserted unexpected results do not commensurate with the scope of the claims. Furthermore, as provided in MPEP 716 (b)(III) “Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d)- § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971). Applicant does not provide comparison between the claimed composition (specific fatty acid with specific amount) and the composition of Petrie.
Applicant argues:
Petrie does not teach or suggest why one would select any one of these techniques over any other, nor how they would provide the claimed composition. Further, claim 15 (and new claims 20 and 22) requires that the lipid mixture is subjected to a first distillation step to obtain a first residue, which is then subjected to a second distillation step to obtain a second residue. [Remarks, pg. 6, 2nd para.].
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive. Petrie teaches a method of manufacturing the fatty acid composition comprising purification, transesterification and fractionation of the oils, wherein the method include treatment with ethyl esters and distillation. The method comprises firstly purifying the oil and/or transesterification, and/or fractionation of the oil to increase the level of DHA. In a particular embodiment, the method comprises treating the lipid or oil such as canola oil to convert the fatty acids in the oil to alkyl esters such as methyl or ethyl esters. Further treatment such as fractionation or distillation is applied to enrich the lipid or oil for the DHA. Petrie further describes the transesterification process wherein after ethyl transesterification, the fatty acid fractionation to increase the concentration of PUFA in an oil can be achieved by any of the methods known in the art, such as, molecular distillation. [Petrie, pg. 36, 0609]. Petrie’s teachings above show that the method include first purifying, and then increase the concentration of the fatty acids by fractionation or distillation. Petrie manufacturing process include two steps to extract and produce the fatty acids include the step of purifying, and then taking the purified oil to the next step of fractionation/distillation. Thus, Petrie teaches manufacturing process similar to the claimed manufacturing process. These techniques are well known in the art and is considered within the competence level of an artisan of ordinary skill in the field of organic chemistry. Selecting one of these techniques is considered routine and does not require undue experimentation.
Conclusion
Claims 1-5 and 9-22 are rejected.
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 MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622