DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 12, 2025, has been entered.
Claims 2-4 are cancelled.
Claims 1 and 5-17 are pending. Claims 13-17 are withdrawn.
Claims 1 and 5-12 are examined on the merits.
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.
Claims 1 and 5-12 are 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 is indefinite because it is unclear whether “the nitrogen source” of the second-to-last line is referring to the “additional nitrogen source” of line 5. Since claim 1 is indefinite, then its dependent claims, claims 5-12, are rendered indefinite. Therefore, claims 1 and 5-12 are rejected under 35 U.S.C. 112(b).
Claim 10 is indefinite because it is unclear whether the omega-3 fatty acids are included with the proteins as being 50 wt% or more of the biomass, based on the total weight of the biomass. That is, it is unclear whether the biomass comprises (i) 50% wt% or more of proteins and omega-3 fatty acids, based on the total weight of biomass (i.e., proteins and omega-3 fatty acids are 50 wt% or more of the biomass), or (ii) omega-3 fatty acids and 50 wt% or more of proteins, based on the total weight of the biomass (i.e., the biomass comprises omega-3 fatty acids and further comprises 50 wt% or more of proteins, based on the total weight of the biomass). Claim 10 is confusing because “based on the total weight of the biomass” is recited after the recitation of omega-3 fatty acids. For the purpose of applying prior art, claim 10 is being interpreted as: The method according to claim 1, wherein the biomass comprises omega-3 fatty acids and further comprises 50 wt% or more of proteins, based on the total weight of the biomass.
Notice Re: Prior Art Available Under Both Pre-AIA and AIA
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.
Claim Rejections - 35 USC § 103
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.
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 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (KR 20160128816. Listed on IDS filed 2/24/23. Machine Translation cited below).
Lee discloses culturing microalgae for a period of time until the increase in the concentration of nitrogen is maintained at a high concentration so as to provide a microalgae culture method which can increase the yield and productivity of the lipid material to be used as biodiesel (paragraphs [0001] and [0012]). The microalgae can be Schizochytrium (paragraph [0042]). This microalgae is directed to thraustochytrid microalgae, specifically directed to a thraustochytrid microalgae of instant claim 7 (see also page 3, first paragraph of the instant specification recognizing Schizochytrium as a thraustochytrid microalgae).
The culture method comprises incubating the microalgae at a high nitrogen concentration of 300 to 5,000 mg/L which can increase the lipid productivity of microalgae (paragraphs [0013], [0031], and [0061]). 300 to 5,000 mg/L converts to 300 ppm to 5,000 ppm, which falls with the claimed range of ‘300 ppm or more’ for total nitrogen concentration. Furthermore, the nitrogen of Lee can be sodium nitrate, ammonium nitrate, ammonium chloride, ammonium acetate, or urea (paragraph [0018]-[0019]). These meet limitations of the nitrogen source in the medium of instant claim 5.
Additionally, Lee teaches that the culture medium comprises an organic carbon (paragraph [0036]). Organic carbon is directed to a carbon source.
Therefore, Lee meets limitations of the claimed invention by disclosing a method of preparing a biomass (the lipid-containing material produced by the microalgae) derived from thraustochytrid microalgae (Schizochytrium microalgae), wherein the method comprises culturing a single strain of the thraustochytrid microalgae in medium comprising a carbon source (organic carbon) and a nitrogen source (e.g., sodium nitrate, ammonium nitrate, etc.); wherein the total nitrogen concentration in the culture medium is 300 ppm to 5,000 ppm which falls in the claimed range of ‘300 ppm or more.’
In order to maintain the concentration of nitrogen (i.e. 300 ppm to 5,000 ppm nitrogen), Lee discloses that a continuous supply of nitrogen is provided at time intervals over 12 hours (paragraph [0035]). Continuously supplying the nitrogen is directed to continuously supplying ‘an additional nitrogen source’ into the culture medium during the culturing since the nitrogen (i.e. ‘nitrogen source’) that is continuously supplied is in addition to the nitrogen (directed to a ‘nitrogen source’) present in the culture medium in which the microalgae is cultured. Lee differs from the claimed invention in that Lee does not explicitly disclose that the nitrogen source (being interpreted by the Examiner as the ‘additional nitrogen source’) is supplied from immediately after inoculating the microalgae (the Schizochytrium microalgae) into the culture medium to the end of the culture. However, since Lee teaches culturing in high concentrations of nitrogen conditions of 300 to 5,000 mg/L (i.e., 300 ppm to 5,000 ppm total nitrogen) from the beginning increases in both the growth and lipid content of algae (paragraph [0044]), then, before the effective filing date of the claimed invention, the skilled artisan would have been motivated to continuously supply the nitrogen throughout the culturing, which is directed to continuously supplying the nitrogen immediately after inoculation of the microalgae into the culture medium and to the end of the culturing. Moreover, it is noted that any time point after the beginning of culturing is directed to the claimed ‘the end of culture.’ Therefore, the end of the time period of over 12 hours for the continuous supply of the nitrogen, such as the 24-hour period of time disclosed in Lee (paragraph [0049]), is directed to the claimed ‘the end of culture.’
As such, Lee renders obvious instant claims 1, 5 (sodium nitrate, ammonium nitrate, ammonium chloride, ammonium acetate, or urea as disclosed in paragraph [0018]-[0019]), and 7 (Schizochytrium).
Regarding instant claim 6, Lee discloses that the organic carbon in the culture medium is preferably glucose or glycerol (paragraph [0036]). Therefore, instant claim 6 is rendered obvious.
Regarding instant claim 8, Lee discloses that their invention relates to a culture method of microalgae to produce a raw material of biodiesel (paragraph [0001]). Biodiesel is an alternative to petroleum-based diesel (paragraph [0003]). The lipid component contained in algae may be used as a raw material for the production of biodiesel to be used as a liquid fuel (paragraph [0005]). Since the lipid product of the invention of Lee is sought as a biodiesel for use as a liquid fuel, then before the effective filing date of the claimed invention it would have been obvious to the skilled artisan to recover the lipid-containing biomass and specifically the lipids (directed a ‘cultured product’) to obtain the product for use as biodiesel. Therefore, instant claim 8 (at least ‘biomass from the strain’ and ‘cultured product of the strain’) is rendered obvious.
Regarding instant claim 9, Lee differs from the claimed invention in that Lee does not expressly disclose that the biomass produced by their method comprises 50 wt% or more of proteins and 37 wt% or less of fats, based on the total weight of the biomass. However, Lee recognizes that because the protein and lipid content is high in microalgae biomass, then it can be used as food, feed, or fuel (paragraph [0004]). Therefore, it would have been obvious to the person of ordinary skill in the art that the biomass produced by the method rendered obvious by Lee comprises proteins and fats (the lipids). Moreover, since Lee renders obvious the claimed method, then it would have been obvious that the biomass obtained from performing the same claimed steps necessarily possesses the same properties as the claimed biomass, including meeting the claimed protein and fats weight percentages. Thus, instant claim 9 is rendered obvious.
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Lee as applied to claims 1 and 5-9 above, and further in view of Pfeifer III (US 2013/0172590).
As discussed above, Lee renders obvious claims 1 and 5-9. Regarding claim 10, as set forth in the rejection of claim 9, Lee renders obvious a biomass produced by their method that comprises 50 wt% or more of proteins, based on the total weight of the biomass. Lee differs from claim 10 in that Lee does not expressly disclose the biomass comprises omega-3 fatty acids. Additionally, Lee further differs from claim 11 in that Lee does not expressly disclose that the omega-3 fatty acids comprise any one or more of docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA). Lee further differs from claim 12 in that Lee does not expressly disclose that the biomass comprises 15 wt% to 60 wt% of omega-3 fatty acids, based on the weight of the total fatty acids.
Pfeifer III discusses thraustochytrids, including members of the genus Schizochytrium, pointing out that they have been recognized as an alternative source of omega-3 fatty acids, including DHA and EPA (paragraph [0008]). In Example 2, Pfeifer III discloses a Schizochytrium sp. cultivated in a culture medium which produces a biomass comprising EPA and DHA (paragraph [0219] and Table 5).
Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to expect that the biomass produced by culturing Schizochytrium microalgae according to the method rendered obvious by Lee comprises omega-3 fatty acids, specifically DHA and EPA. The person of ordinary skill in the art would have expected this because Schizochytrium are known to produce omega-3 fatty acids, including DHA and EPA, as indicated in Pfeifer III. Therefore, Lee renders obvious instant claims 10 and 11.
Furthermore, since Lee in view of Pfeifer III renders obvious the claimed method, then it would have been obvious that the biomass obtained from performing the same steps necessarily possesses the same properties as the claimed biomass, including meeting the claimed omega-3 fatty acids weight percentage of the total fatty acids of instant claim 12. Therefore, Lee in view of Pfeifer III renders obvious instant claim 12.
Response to Arguments
Applicant’s arguments, filed December 12, 2025, with respect to the objections to claims 1, 2, and 4-12, the rejection under 35 U.S.C. 112(b) of claims 1, 2, and 4-12, the rejection under 35 U.S.C. 112(d) of claim 4, and the rejection under 35 U.S.C. 103 of claims 1, 2, and 4-12 as being unpatentable over Caulier in view of Lee, have been fully considered and are persuasive. In particular, the claim objections have been overcome by the amendments to claims 1 and 7. The rejection under 35 U.S.C. 112(b) has been overcome by the amendment to claim 1. The rejection under 35 U.S.C. 112(d) has been rendered moot by the canceling of claim 4. The rejection under 35 U.S.C. 103 has been withdrawn in light of Applicant’s arguments on page 5 of the Remarks filed December 12, 2025. The invention of Caulier is based on the control of the growth rate of the microalgae, this control being exerted so as to reduce it to its minimum, while at the same time maintaining or continuously introducing a nitrogen source in or into the fermentation medium (paragraph [0080]). However, Lee discloses that their invention increases the growth rate of the microalgae (paragraph [0028]), wherein the invention of Lee relies on using a concentration of nitrogen from 300 to 5000 mg/L, i.e., 300 to 5000 ppm (paragraph [0029]). Lee discloses in paragraph [0031] that if the nitrogen concentration in the culture medium is less than 300 mg/L (i.e., less than 300 ppm), cell growth is inhibited. Since Caulier sought to control the growth rate of the microalgae to its minimum, then one of ordinary skill in the art would have been motivated to use the low nitrogen concentration (less than 300 ppm) of Lee which inhibits cell growth, instead of the nitrogen concentration of Lee which meets the claimed limitation of 300 ppm or more. As such, these objections and rejections have been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Lee. Also, new rejections under 35 U.S.C. 112(b) are set forth.
Conclusion
No claims are allowed.
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Sef
/SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
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