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 .
Status of the Claims
This Office Action is in response to the paper filed on 7/23/2026. Claims 1-3 are pending and under examination (claim set as filed on 7/23/2026). Claims 1-3 are amended.
Priority
Applicant is advised of possible benefits under 35 U.S.C. 119(a)-(d) and (f), wherein an application for patent filed in the United States may be entitled to claim priority to an application filed in a foreign country.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. TÜRKİYE 2021/011356, filed on 7/12/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/12/2024 was considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed towards a natural product without significantly more.
With regards to Step 1, the antimicrobial bioactive extract of ethyl acetate comprising aliphatic chloro-compounds, phenolic compounds, stearic acid, palmitic acid, palmitoleic acid, oleic acid, linolenic acid, and linoleic acid in claim 1 is a composition of matter.
With regards to Step 2A, prong one, claim 1 recites an antimicrobial bioactive extract of ethyl acetate comprising aliphatic chloro-compounds, phenolic compounds, stearic acid, palmitic acid, palmitoleic acid, oleic acid, linolenic acid, and linoleic acid. The claimed lipid extracts are judicial exceptions as they are natural products merely isolated from ethyl acetate which produces them inherently (see specification pg. 4, ¶ 1).
With regards to Step 2A, prong two, claim 1 does not recite additional elements to the antimicrobial bioactive extract to integrate it into the instant application. Claim 1 recites a product-by-process limitation as indicated by the “obtained from” language. The product-by-process limitation does not integrate the judicial exception into the application as patentable weight is given to the end product resulting from the steps performed and not the steps themselves per se. See MPEP 2113. As such, there are no additional elements that apply or use the judicial exception in some other meaningful way.
With regards to Step 2B, claim 1 does not recite any additional elements that amount to significantly more than the judicial exception itself and therefore is not patent eligible.
For the following reasons, claim 1 is not deemed to encompass subject matter eligible material under 35 USC § 101 and the rejection still stands.
Withdrawal of Rejections
Rejection of claim 3 under 35 U.S.C. 112(b) (pre-AIA ) for being indefinite due to the unclear term “approximately” and lack of antecedent basis regarding the term “the Tris-Acetate-Phosphate (TAP) nutrient medium” is withdrawn following amendments to the claim.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over in view of Wu (Wu et al., “Enhanced extraction of lipids from microalgae with eco-friendly mixture of methanol and ethyl acetate for biodiesel production”, 2016 Dec 30, Journal of the Taiwan Institute of Chemical Engineers, 71, pgs. 323-3290) and further in view of El-Shafie (Pre-Grant Publication No. US 2014/0302570 A1– date of publication 10/9/2014).
Wu’s general disclosure relates to the extraction of lipids from Chlorella spp. biomass culture through an ethyl acetate-methanol solvent (see abstract and pg. 324, ¶ 4).
Regarding claim 1, Wu teaches ethyl acetate extracted from a Chlorella spp. microalgae biomass culture (see abstract and pg. 324, ¶ 4) and wherein the extract also comprises the lipids stearic acid, palmitic acid, palmitoleic acid, oleic acid, linolenic acid, and linoleic acid (see pg. 328, ¶ 1).
Regarding the steps performed to arrive at the claimed structure as indicated by the “obtained by” language recited, this is considered to be a product-by-process limitation. In product-by-process claims, the patentability of the product is dependent on the end product itself, not the process steps per se. The process steps are only considered when they are expected to impart distinct structural characteristics to the final product. See MPEP 2113. For the extract Auxenochlorella protothecoides microalgae grown in a medium with a nitrogen content of 0.8 mM limitation in claim 1, the burden of proof must shift to the applicant to prove that this limitation imparts a distinct structural feature. Furthermore, the limitation of the “wherein” clause is an inherent feature of the product claimed and thus does not impart any further limiting structural features.
However, Wu does not teach the ethyl acetate extract comprises a chlorine compound or a phenolic compound.
El-Shafie’s general disclosure relates to a method of extracting lipids and non-lipids from an algae biomass culture (see [0015]) and wherein the extracted chlorine compounds and phenolic compounds convey disinfectant properties for the culture (see [0087]) .
Regarding claim 1, El-Shafie teaches chlorinated compounds, embodied as salt water, in the
algae culture to act as a substrate (see [0019]). El-Shafie also teaches phenol compounds are added to
the substrate, which is then added to the microalgae culture (see [0087]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to add the chlorinated compounds and phenol compounds as taught in El-Shafie
to the ethyl acetate extract as taught in Wu. The ordinary artisan would have been motivated to do so
because El-Shafie teaches that these compounds are used as disinfectants to prevent culture contamination (see El-Shafie [0087]). Therefore, such an addition would be considered an advantage in Wu which also discloses a need for a lipid extraction procedure where there is a reduction in co-extracted non-lipid contaminants (see Wu pg. 323, ¶ 1).
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Andeden (Andeden et al., "Effect of alkaline pH and nitrogen starvation on the triacylglycerol (TAG) content, growth, biochemical composition, and fatty acid profile of Auxenochlorella protothecoides KP7", 2020 Jun 26, Journal of Applied Phycology, 33, pgs. 211-223), in view of Canelli (Canelli et al., “Biochemical and Nutritional Evaluation of Chlorella and Auxenochlorella Biomasses Relevant for Food Application”, 2020 Sep 30, Frontiers in Nutrition, 7, pgs. 1-9, in view of Alsenani (Alsenani et al., "Evaluation of microalgae and cyanobacteria as potential sources of antimicrobial compounds", 2020 Nov 21, Saudi Pharmaceutical Journal, 28, pgs. 1834-181), in view of Greatwall (Greatwall, "The "Golden Rule" for Solvent Removal When Using a Rotary Evaporator", 2018 Nov 27, https://www.greatwall- nline.com/news/shownews.php-50.htmiPlang-an8id-27, accessed 2026 Mar 18, pg. 1), and as evidenced by Thermo Fisher (Thermo Fisher, “TAP Growth Media, optimized for Chlamydomonas culture”, 2017 Jul 12,https://web.archive.org/web/20170712163512/https://www.thermofisher.com/us/en/home/technical-resources/media-formulation.354.html, accessed 2026 Aug 18).
Andeden's general disclosure relates to lipid production in Auxenochlorella protothecoides microalgae when exposed to different levels of nitrogen containing-media (see abstract).
Regarding claim 2, Andeden teaches growing a biomass from Auxenochlorella protothecoides microalgae in nitrogen media (see Andeden pg. 212, ¶ 2), incubating the biomass (see Andeden pg. 212, ¶ 3), agitating the biomass via shaking in solvent overnight (see Andeden pg. 213, ¶ 3), centrifuging the biomass in solvent to precipitate a pellet (see Andeden pg. 214, ¶ 5), separating the supernatant after centrifugation (see Andeden pg. 213, ¶ 6), and obtaining an concentration of 10-500 mg/L (see Andeden pg. 215, ¶ 5). Andeden teaches the nitrogen media is Tris-Acetate-Phosphate (TAP) (see Andeden pg. 213, ¶ 3) which, as evidenced by Thermo Fisher, is formulated with a nitrogen source of ammonium chloride (NH4Cl) at 7.1 mM (see Thermo Fisher pg. 1, Table 1 – “Inorganic Salts”).
Although Andeden teaches an incubation period, it does not specify that it was exactly 5 days long. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the incubation period as taught in Andeden to 5 days. The ordinary artisan would have been motivated to do so because Andeden teaches that the biomass concentration barely changed during a range of 3-7 days of incubation (see pg. 215, ¶ 7). Therefore, it would be reasonable to optimize the incubation period based on the biomass concentration and one would have been motivated to reduce to a shorter time period such as 5 days if there were no discernable difference in biomass concentration through day 7 and/or increase if the biomass concentration was low.
Although Andeden teaches centrifuging the biomass in solvent to precipitate a pellet, they disclose a centrifugal speed of 2,500 rpm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the centrifugal speed as taught in Andeden to 10,000 rpm. The ordinary artisan would have been motivated to do so because Andeden teaches that using a speed of at least 2,500 rpm was effective enough to separate cells from supernatant (see Andeden pg. 214, 1 5). Therefore, it would be within the skill of the ordinary artisan to manipulate the centrifugal speed to improve upon the method of separating the cells and supernatant.
Andeden does not teach the concentration of the nitrogen is 0.8 mM, that the biomass was lyophilized, that the solvent used was ethyl acetate, that the solvent was evaporated with a rotary evaporator at 40+/-5°C, or that the supernatant was dissolved again with ethyl acetate to its final concentration.
Canelli’s general disclosure relates to the lipid accumulation effect that nitrogen depleted media has on Chlorella spp. and Auxenochlorella spp. strains (see abstract and pg. 5, ¶ 1).
Regarding claim 2, Canelli teaches nitrogen depleted media for growing Chlorella spp. algae (see pg. 5, ¶ 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to look to the teaching of Canelli and optimize the nitrogen as taught in Andeden to the claimed amount of 0.8mM. The ordinary artisan would have been motivated to do so because Canelli teaches that when culturing green algae species such as Chlorella, nitrogen depletion can actually promote lipid accumulation in cells (see Canelli pg. 5, ¶ 1). Further, Andeden teaches that the pH of the culture can be manipulated to discover the optimal value that induces the highest lipid content (see Andeden pg. 213, ¶ 3). Thus, an ordinary artisan would have been motivated to also manipulate the nitrogen concentration to enhance lipid accumulation in the cells.
Andeden does not teach that that the biomass was lyophilized, that the solvent used was ethyl acetate, that the solvent was evaporated with a rotary evaporator at 40+/-5°C, or that the supernatant was dissolved again with ethyl acetate to its final concentration.
Alsenani's general disclosure relates to determining antimicrobial activity of microalgae species (see abstract) wherein the biomass batches are stored via lyophilization (see pg. 1835, ¶ 8), ethyl acetate is used as a solvent extracting agent (see pg. 1836, ¶ 1), and rotary evaporation and dissolving the biomass in solvent are techniques used to dry and remove impurities from the biomass (see pg. 1836, ¶ 1).
Regarding claim 2, Alsenani teaches freeze-drying the biomass (see pg. 1835, ¶ 8). "Lyophilization" is defined as the process of freeze-drying and so freeze-drying is referred to as lyophilization onwards. Alsenani also teaches the solvent ethyl acetate (see pg. 1835, ¶ 8 and pg. 1836 ¶ 1), that the ethyl acetate solvent was evaporated with a rotary evaporator (see pg. 1836, ¶ 1), and that the supernatant was dissolved again in ethyl acetate solvent (see pg. 1836, ¶ 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the lyophilization step as taught in Alsenani to the overall extraction method as taught in Andeden. The ordinary artisan would have been motivated to do so because Alsenani discloses that lyophilization is used to store biomass batches (see Alsenani pg. 1835, ¶ 8). Therefore, such an addition of this step would be considered an advantage in Andeden which discloses a need for collecting and storing the biomass cells for sample preparation prior to the extraction process (see Andeden pg. 212, ¶ 4-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute ethyl acetate as taught in Alsenani in place of one of the solvents used in Andeden. The ordinary artisan would have been motivated to do so because both ethyl acetate and methanol can be used to extract the biomass as demonstrated by Alsenani (see Alsenani pg. 1836, ¶ 1) and Andeden (see Andeden pg. 214, ¶ 6). Therefore, both solvents are considered functional equivalents. As such, the use of ethyl acetate solvent during the biomass extraction process would have offered a reasonable expectation of success for the ordinary artisan.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the rotary evaporation step as taught in Alsenani to the biomass extraction method as taught in Andeden. The ordinary artisan would have been motivated to do so because Alsenani teaches that this technique is useful for completely removing residual solvent from the biomass (see Alsenani pg. 1836, ¶ 1). Therefore, the use of the rotary evaporator would be considered an advantage in Andeden which discloses washing the biomass with water to remove remaining solutions (see Andeden pg. 213, ¶ 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the step of dissolving the supernatant in solvent an additional time. The ordinary artisan would have been motivated to do so because Alsenani teaches that this technique is used to remove impurities (see Alsenani pg. 1836, ¶ 1). Therefore, such an addition of this step would be considered an advantage in Andeden which discloses collecting the supernatant and quantifying its lipid content (see Andeden pg. 214, ¶ 5) where the presence of impurities may affect the analysis.
However, Alsenani does not teach that the solvent was evaporated in the rotary evaporator at 40+/-5°C.
Greatwall's general disclosure relates to guidance of temperature settings when using rotary evaporators (see pg. 1).
Regarding claim 2, Greatwall teaches the temperature range of 40+/-5°C during the rotary evaporation (see pg. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try the utilizing the rotary evaporator as taught by Alsenani at 40+/-5°C. The ordinary artisan would have been motivated to do so because Greatwall teaches that it is considered a general "rule" to operate the device at this temperature (see Greatwall pg. 1). Therefore, it would be reasonable to expect the ordinary artisan to try the 40+/- 5°C temperature range as this would be a standard practice in the art.
Regarding claim 3, Andedenteaches the nitrogen media is Tris-Acetate-Phosphate (TAP) (see Andeden pg. 213, ¶ 3). As evidenced by Thermo Fisher, this media is formulated with a nitrogen source of ammonium chloride (NH4Cl) at 7.1 mM (see Thermo Fisher pg. 1, Table 1 – “Inorganic Salts”). Regarding claim 1, Andeden teaches a Auxenochlorella protothecoides microalgae grown in nitrogen stress media (see pg. 212, ¶ 2). Claim 1 recites a product-by-process limitation regarding the steps recited to result in the bioactive antimicrobial ethyl acetate extract. See MPEP 2113. Even if the product-by-process limitation yields a specific product, the combined references of modified-Andeden-Cannelli-Alsenani-Greatwall would result in the same product or a similar one as the primary reference Andeden teaches the same microalgae and nitrogen stress medium and Cannelli teaches a process culturing microalgae in nitrogen-depleted media. As such, one would obtain the same ethyl acetate extract end product.
Response to Arguments
Applicant's arguments filed 7/23/2026 have been fully considered but they are not persuasive.
All Claim Limitations Must Be Disclosed in Prior Art
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The amendments to the claims have necessitated the use of new prior art references Wu and Thermo Fisher to teach or provide evidence for the new limitations.
Regardless, the applicant’s argument that the prior art does not teach the new limitations recited in the amended claims, this is rendered moot as the amendments to the claim render it a product-by-process claim. See MPEP 2113. In product-by-process claims, the patentability of the product is dependent on the end product itself, not the process steps per se. The process steps are only considered when they are expected to impart distinct structural characteristics to the final product. The end product of an ethyl acetate extract comprising the lipids stearic acid, palmitic acid, palmitoleic acid, oleic acid, linolenic acid, and linoleic acid as well as chlorine compounds and phenolic compounds are taught in combined references Wu and El-Shafie. Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing a nonobvious difference between the claimed product and the prior art product.
Optimization and Criticality of Ranges
Applicant argues that the nitrogen concentration of 0.8 mM is a critical feature that is not taught or suggested in the prior art references and that obviousness of range optimization must be supported by more than mere parameters existing in the art. However, it should be noted that the burden lies on the applicant to provide evidence establishing that the difference in the claimed results and the prior art results are unexpected, critical, and unobvious by providing statistically significant proof. See MPEP 716.02.
Inventor Identified a Problem Others Did Not
Applicant argues that the prior art cited would give the ordinary artisan no reason to select an intermediate nitrogen content media of 0.8 mM and that the prior art itself gives no reason to arrive at that concentration. However, the prior art does teach the nitrogen-containing media and further provides reason as to why the ordinary artisan would have cause and motivation to manipulate the nitrogen concentration to the claimed value of 0.8 mM.
Claim 2
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim 3
Applicant argues the nitrogen-stress media taught in the prior art is for the purpose of lipid accumulation and not for antimicrobial extract production process. However, the process steps as claimed as taught in the prior art references are the same as the claimed process steps, and the preamble is merely the statement of the purpose and is not considered to be a limitation. See MPEP 2111.02. Furthermore, the recited 0.11× TAP nitrogen concentration is not a claimed limitation in claim 3 as the claim was amended to only include TAP media with 0.8 mM NH4Cl and thus renders moot the applicant’s argument that this is a ratio not taught in the literature and thus conveys novelty.
Conclusion
No claims are allowed.
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.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emmalee R. Williams whose telephone number is (571)272-5472. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMALEE R WILLIAMS/ Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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