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 .
DETAILED ACTION
Claims 1 and 6-18 are pending and under examination on their merits.
The rejection of claims 1 and 6-18 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendment.
The rejection of claims 1 and 13 under 35 U.S.C. 112(a) is withdrawn in view of Applicant’s amendment.
Response to Arguments
Applicant's arguments filed 8/28/2025 have been fully considered but they are not persuasive.
Applicant argues against the rejection of claims 1 and 6-18 under 35 U.S.C. 103 over Okita in view of Hoshino on the grounds that the percentage of recovery of docosahexaenoic acid in the presently claimed method is no less than 80%, whereas the recovery rate of Okita is 53.6%.
In response, the recovery rate of docosahexaenoic acid is not recited within any of the claims. Furthermore, Okita teaches the same active steps of the method (i.e. hydrolysis by the same enzymes) except for the lower reaction temperature and shorter reaction duration. Hoshino provides motivation for reducing the reaction temperature (to decrease the odor of the fish oil). Therefore, modifying Okita per Hoshino would have necessarily resulted in the same DHA recovery as the claimed invention.
Applicant discusses the reaction conditions of Doisaki and Tominaga (Arguments, middle of page 8 and paragraphs 1-2 on page 9), but these are not relevant to the rejections of record as Doisaki and Tominaga are not relied on to teach reaction conditions. Rather, these references were previously cited in the response to Applicant’s arguments as evidence that lower reaction temperatures are practiced in the art of hydrolysis.
Applicant argues that the person of ordinary skill in the art would not have been motivated to use the reaction conditions of Hoshino for hydrolysis of Okita because the process of Okita is for selectively concentrating DHA and Hoshino does not provide any motivation to do so (Arguments, bottom paragraph on page 9).
This argument is not persuasive because Hoshino teaches that lower reaction temperatures reduce unpleasant fish odor (page 1466, paragraph bridging left and right columns). Furthermore, per MPEP 2144 (IV), to support a rejection under 35 U.S.C. 103, rationale different from Applicant’s is permissible.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New Rejection Necessitated by Amendment) Claims 7 and 17-18 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 7 fails to further limit the subject matter of claim 1 because the limitation “wherein the proportion of docosahexaenoic acid in fatty acid composition of the glyceride fractions after the reaction is no less than 47 area%” is already recited in claim 1.
Claim 17 fails to further limit the subject matter of claim 1 because claim 17 recites a broader range for the sum of docosahexaenoic acid and eicosapentaenoic acid in the fatty acid composition of the glyceride fraction (54 area% or higher) than claim 1, which recites “wherein the sum of docosahexaenoic acid and eicosapentaenoic acid in fatty acid composition of the glyceride fractions after the reaction is no less than 53 area% and up to about 57.5 area%.
Likewise, claim 18 fails to further limit the subject matter of claim 13 because claim 18 recites a broader range (54 area% or higher) for the sum of docosahexaenoic acid and eicosapentaenoic acid in the fatty acid composition of the glyceride fraction than the narrower range recited in claim 13 (no less than 53 area% and up to about 57.5 area%).
Applicant may cancel the claims, amend the claims to place the claims in proper dependent form, rewrite the claims in independent form, or present a sufficient showing that the dependent claims complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
(New Rejection Necessitated by Applicant’s Amendment) Claims 17-18 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 17 and 18 recite “wherein the sum of docosahexaenoic acid and eicosapentaenoic acid in fatty acid composition of the glyceride fractions after the reaction is 54 area¾ or higher.”
The claim limitation “54 area% or higher” is interpreted as including values from 54 area% to 100 area%. The person of ordinary skill in the art would not have recognized that the inventors were in possession of the claimed genus of compositions with a total concentration of DHA and EPA higher than 54 area%.
Claim 17 depends from claim 13 and claim 18 depends from claim 1. Claims 1 and 13 are both drawn to a method of hydrolysis of a feedstock by the action of Candida cylindracea lipase and a partial glyceride lipase from Penicillium camemberti to produce a composition comprising DHA and EPA. Table 5 on page 23 of the specification demonstrates the area% of DHA and EPA for reactions performed with different ratios of the lipases and different reaction times. The reaction temperature is 18 °C (see specification [0058] and [0070]). The specification also discloses the area% of DHA and EPA for reactions performed at 30 °C for 10 hours: see [0067] and Table 4 in [0069]. In summary, Applicant discloses the correlation between reaction time, reaction temperature, and the activity ratio of Candida cylindracea lipase to partial glyceride lipase. The highest value attained for the total area% of DHA and EPA in the fatty acid composition of the glyceride fractions is 57.3 area% (Example 1) presented in Table 1 ([0064]) for a reaction time of 24 h and a reaction temperature of 18 °C. At 18 °C, increasing the reaction time from 10 to 24 h increases the total area% of DHA and EPA from 55.5 area% (10 h) to 57.3 area% (24 h), which is an increase of 1.8 area%. At 30°C, the total area% for DHA and EPA after 10 h is 54.8 area%. Therefore, even by extrapolating from 10 h to 24 h for a reaction temperature of 30 °C, the person of ordinary skill in the art would not have expected values significantly higher than 57.3 area%.
Okita et al. (WO1998018952A1) exemplifies the hydrolysis of tuna oil with 200 units of Candida cylindracea-derived lipase and 40 units of Penicillium camemberti-derived lipase at 35°C for 16 hours to obtain a glyceride fraction containing 49.7% total DHA and EPA (page 6, Example 4; 40.86% DHA plus 8.84% EPA).
Okita also exemplifies the hydrolysis of tuna oil with 1600 units of Candida cylindracea-derived lipase and 400 units of Penicillium camemberti-derived lipase at 35°C for 20 hours to obtain a glyceride fraction containing 53.6% total DHA and EPA. (page 6, Example 5; 48.10% DHA plus 5.50% EPA).
Based on the above analysis, the person of ordinary skill in the art would not have recognized that the inventors at the time the application was filed had possession of the claimed genus of compositions with a total concentration of DHA and EPA of higher than 54 area%.
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 and 6-18 are rejected under 35 U.S.C. 103 as being unpatentable over Okita et al. (WO1998018952A1) in view of Hoshino et al. (Agricultural and Biological Chemistry 54.6 (1990): 1459-1467) as evidenced by Chemical Book (cited in the Non-Final Action mailed on 8/22/2024).
Okita exemplifies the hydrolysis of 2 ml tuna oil with 200 units of Candida cylindracea-derived lipase and 40 units of Penicillium camemberti-derived lipase at 35°C for 16 hours to obtain a glyceride fraction containing 40.86% DHA, 8.84% EPA, and 4.62 DHA/EPA (page 6, Example 4).
Okita also exemplifies the hydrolysis of 2 ml tuna oil with 1600 units of Candida cylindracea-derived lipase and 400 units of Penicillium camemberti-derived lipase at 35°C for 20 hours to obtain a glyceride fraction containing 48.10% DHA, 5.50% EPA, and 8.75 DHA/EPA (page 6, Example 5). The density of fish oil, which is the feedstock oil, is 0.93 g/mL, as evidenced by Chemical Book (see “Fish oil properties”), so Okita teaches approximately 860 units per gram feedstock oil. Therefore, Okita teaches an activity ratio of Candida cylindracea-derived lipase to Penicillium camemberti-derived lipase of 860: 215 or 1: 0.25. Okita’s Candida cylindracea-derived lipase units approach the instantly claimed range and the activity ratio is within the claimed range. Therefore, a prima facie case of obviousness exists. See MPEP 2144.05.
Both lipases are used simultaneously (i.e. both are present at the beginning of hydrolysis) because both are added at the same time (Examples 4 and 5 on page 6). The tuna oil (feedstock oil) contains glycerides comprising DHA as a constituent of fatty acids (see paragraph 1 of Example 1 on page 5, which describes the same tune oil as Example 5 on page 6). The lipase derived from Penicillium camemberti is a partial glyceride lipase because it acts on monoglycerides and diglycerides rather than triglycerides (paragraph 5 on page 4).
The hydrolysis reaction time required for the proportion of DHA to become 47 area% and above is shortened compared to the case where the partial glyceride lipase is not used. See Comparative Example 3 of Okita on page 6, which demonstrates that hydrolysis by a Candida cylindracea-derived lipase alone (without a Penicillium camemberti-derived lipase) results in less DHA in the glyceride fraction at the same reaction conditions.
Regarding claims 1 and 13, Okita does not teach that the lipase hydrolysis reaction is performed at a temperature between about 10 and 25 °C for a period no longer than 15 hours. Rather, Okita’s hydrolysis reactions in Examples 4 and 5 on page 6 are performed at 35°C for 16 hours (Example 4) or 35°C for 20 hours (Example 5).
Hoshino teaches performing the hydrolysis of fish oil by a Candida cylindracea-lipase at 20 °C and varies the reaction time between 10 and 40 hours (Abstract and Table II on page 1466). Hoshino teaches that lower reaction temperatures reduce the unpleasant odor of fish oil, even for longer incubation periods (page 1466, paragraph bridging left and right columns). Hoshino compares hydrolysis for different temperatures: Figure 3 shows hydrolysis at 20 °C and Figure 8 shows hydrolysis at 15, 30, and 40 °C. Hoshino also teaches that the use of higher temperatures does not cause a higher final hydrolysis percentage and that the major glyceride was triglycerides even at a high hydrolysis percentage (page 1465, right column, top paragraph). In other words, Hoshino teaches similar hydrolysis results for both low and high temperatures.
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize the reaction conditions of Okita’s method through routine experimentation in order to balance operating costs associated with higher temperatures and longer reaction times with the concentration of DHA and EPA. The person of ordinary skill in the art would have been motivated to modify the method of Okita to shorten the reaction time to 15 hours or less and to limit the hydrolysis temperature to between about 10 and 25°C in order to reduce operating costs as well as to reduce the unpleasant odor of fish oil associated with higher reaction temperatures and longer incubation periods. The person of ordinary skill in the art would have had a reasonable expectation of success given that Okita teaches reaction conditions that are similar to the claimed ranges (see Examples 4 and 5 of Okita on page 6) and furthermore Okita teaches the results-effective variables that control the amount of DHA and EPA in the glyceride fraction. Namely, Okita teaches that enzyme units, duration of the hydrolysis reaction, and the addition of a partial glyceride lipase control the amount of DHA and EPA in the glyceride fraction (see Example 4, Example 5, and Comparative Example 3 on page 6). Therefore, the person of ordinary skill in the art would have had a reasonable expectation of success in optimizing Okita’s method by reducing the reaction time and temperature. Furthermore, Hoshino teaches that the n-3 PUFA content in the glycerides only changes from 43.1 to 45.6% between 10 and 20 h for a reaction at 20 °C (Table II). Therefore, the person of ordinary skill in the art would have expected the concentration of DHA and EPA to remain similar to that taught by Okita, despite the reduction in reaction time and temperature.
Regarding claims 1 and 13, as amened, Okita teaches that hydrolyzing tuna oil with 1600 units Candida cylindracea-derived lipase and 400 units Penicillium camemberti-derived partial lipase at 35°C for 20 hours results in a glyceride fraction containing 48.10% DHA (page 6, Example 5), which is a value no less than 47%. Hoshino teaches that reducing the reaction time from 20 h to 10 h only slightly reduces the n-3 PUFA percentage in glycerides, so the reduction in reaction time would not have significantly changed either DHA or EPA concentration. Okita teaches an EPA concentration in the glyceride fraction of 5.50% (Example 5, hydrolysis reaction for 20 hours) and 8.84% (Example 4, hydrolysis reaction for 16 hours). A comparison of reaction conditions in Examples 4 and 5 illustrates that reducing reaction time slightly increases the amount of EPA in the glyceride fraction. Therefore, optimizing Okita’s method to reduce operating costs and to reduce the unpleasant odor of fish oil by reducing the reaction time and temperature would have resulted in values approaching the claimed range of no less than 47 area% DHA and no less than 6 area% EPA in the glyceride fraction (i.e. 53 area% total DHA and EPA).
Regarding claim 6, Okita teaches a hydrolysis reaction temperature of 35°C (Example 5 on page 6). As discussed above with respect to independent claims 1 and 13, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize Okita’s reaction conditions by reducing hydrolysis reaction temperature in order to minimize operating costs and to reduce the unpleasant odor of fish oil.
Regarding claim 7, Okita teaches that hydrolyzing tuna oil with 1600 units Candida cylindracea-derived lipase and 400 units Penicillium camemberti-derived partial lipase at 35°C for 20 hours results in a glyceride fraction containing 48.10% DHA (page 6, Example 5), which is a value no less than 47%. Hoshino teaches that reducing the reaction time from 20 h to 10 h only slightly reduces the n-3 PUFA percentage in glycerides, so the reduction in reaction time would not have significantly changed either DHA or EPA concentration.
Regarding claim 8, Okita teaches an EPA concentration in the glyceride fraction of 5.50% (Example 5, hydrolysis reaction for 20 hours) and 8.84% (Example 4, hydrolysis reaction for 16 hours). A comparison of reaction conditions in Examples 4 and 5 illustrates that reducing reaction time slightly increases the amount of EPA in the glyceride fraction. Therefore, it would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention that optimizing Okita’s method to reduce operating costs by reducing the reaction time and temperature would have resulted in no less than 7 area% EPA in the glyceride fraction.
Regarding claim 9, Okita teaches adding 2 mL water to 2 mL of tuna oil (Examples 4 and 5 on page 6). The density of fish oil is approximately 0.93 g/mL, as evidenced by Chemical Book (see “Fish oil properties”). Therefore, Okita teaches adding roughly 2 g water per 2.2 g tuna oil (i.e. 0.9 g per g feedstock oil), which is a value within the instantly claimed range of. 0.2 to 1.2 g per g feedstock oil. Therefore, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claims 10 and 12, Okita teaches that the hydrolysis rate (%) is the acid value/saponification value of the raw oil × 100 (paragraph 9 on page 5). Okita’s hydrolysis rate is 52.6% in Example 4 and 74.0% in Example 5. The tuna oil is saponification value is 185 (Example 1 paragraph 1 on page 5). Therefore, Okita teaches terminating the reaction when the acid value is 97 (Example 4) and 137 (Example 5). Both acid values are within the claimed range of between 90 and 150 (claim 10). The reaction of Example 4 is terminated at an acid value of 97, which is within the claimed range of 90 and 110 (claim 12). Therefore, a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 11, Okita teaches recovering the glyceride fraction because Okita teaches deacidifying and dehydrating the hydrolysate to obtain a glyceride fraction (Examples 4 and 5 on page 6).
Regarding claim 13, Okita teaches that the addition of the partial glyceride lipase increases the total concentration of DHA and EPA compared to the case where the partial glyceride lipase is not used (see Comparative Example 3 on page 6: 31.82% DHA + 9.08% EPA compared to 40.86% DHA and 8.84% EPA in Example 4).
Regarding claims 14-16, Okita’s reaction temperatures in Examples 4 and 5 are greater than those claimed in 14-16. However, as discussed above with respect to claims 1 and 13, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to reduce both reaction temperature and time in order to reduce operating costs and also to reduce the unpleasant odor of the fish oil. The person of ordinary skill in the art would have had a reasonable expectation of success given that Hoshino teaches that reducing the reaction time from 20 h to 10 h only slightly reduced n-3 PUFA concentration in the glyceride fraction and also teaches hydrolysis using a Candida cylindracea-derived lipase at 20°C (Table II; CC=Candida cylindracea).
In addition, per MPEP 2144.05(II)(A), differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.
Regarding claims 17-18, Okita exemplifies the hydrolysis of 2 ml tuna oil with 1600 units of Candida cylindracea-derived lipase and 400 units of Penicillium camemberti-derived lipase at 35°C for 20 hours to obtain a glyceride fraction containing a total of 53.6% total DHA and EPA (page 6, Example 5; 48.10% DHA plus 5.50% EPA), which is a value approaching the claimed range.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 CANDICE LEE SWIFT whose telephone number is (571)272-0177. The examiner can normally be reached M-F 8:00 AM-4:30 PM (Eastern).
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/CANDICE LEE SWIFT/Examiner, Art Unit 1657