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
Claims 1-3 are pending (claim set as filed on 1/12/2024).
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. 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 1/12/2024 is considered, initialed, and attached hereto. The submission is in compliance with the provisions of 37 CFR 1.97.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the term “approximately” which is a relative term which renders the claim indefinite. The term “approximately ” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The amount of nitrogen of the Tris-Acetate-Phosphate (TAP) nutrient medium is rendered indefinite by the use of this term.
Claim 3 recites the limitation "the Tris-Acetate-Phosphate (TAP)" at the end of the claim. There is insufficient antecedent basis for this limitation in the claim.
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 to a natural product without significantly more. The claim recites an bioactive extract comprising Auxenochlorella protothecoides microalgae and extracted lipid compounds. This judicial exception is not integrated into a practical application because only the microalgae bioactive extract is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional limitations claimed beyond the microalgae bioactive extract.
With regards to Step 1, the microalgae bioactive extract in claim 1 is a composition of matter.
With regards to Step 2A, prong one, claim 1 encompasses a microalgae bioactive extract comprising the microalgae species Auxenochlorella protothecoides and its natural lipid extracts. Thus, claim 1 is directed toward a microorganism and the aliphatic chloro-compounds, phenolic compounds, stearic acid, palmitic acid, palmitoleic acid, oleic acid, linolenic acid, and linoleic acid] It should be noted that the mere isolation of an organism from the natural environment is not patent eligible.
With regards to Step 2A, prong two, claim 1 does not recite any elements in addition to the microalgae bioactive extract to integrate into the instant application. The intended use of the application to study antimicrobial activity of the Auxenochlorella protothecoides microalgae and its lipid extract compounds does not in any way change the natural structure or inherent functionality of the Auxenochlorella protothecoides and the lipid compounds. As such, there is no additional elements integrated that apply or use the judicial exception in some other meaningful way.
With regards to Step 2B, claim 1 does not recite any elements other than the microalgae species Auxenochlorella protothecoides and the lipid compounds of aliphatic chloro-compounds, phenolic compounds, stearic acid, palmitic acid, palmitoleic acid, oleic acid, linolenic acid, and linoleic acid. As such, claim 1 does not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
For the following reasons, claim 1 is not deemed to encompass patent eligible subject matter under 35 USC § 101.
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 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) and in view of El-Shafie (US Patent No. 13/382,897 – publication date of 5/17/2012).
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 1, Andeden teaches components of a bioactive extract comprising Auxenochlorella protothecoides microalgae (see abstract), oleic acid and linolenic acid and linoleic acid (see pg. 218, ¶ 4), stearic acid and palmitic acid and palmitoleic acid (see pg. 221, Table 3). Andeden discloses the stearic acid, palmitic acid, and palmitoleic acid as their lipid number ratios of C18:0, C16:0, and C16:1, respectively. Although Andeden discloses a microalgae culture, the microalgae culture is given the broadest reasonable interpretation that it reads on the composition as it contains the essential elements of the Auxenochlorella protothecoides microalgae and the lipid compounds together. However, Andeden does not teach chlorinated compounds or phenolic compounds.
El-Shafie’s general disclosure relates to producing lipids and non-lipids from a microbial biomass (see abstract).
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 algae culture as taught in Andeden. The ordinary artisan would have been motivated to do so because El-Shafie teaches that these compounds are used to either promote the growth of a biomass by acting as a substrate for the algae culture (see El-Shafie [0013]) or to disinfect the substrate to prevent contaminating the culture (see El-Shafie [0087]). Therefore, such an addition would be considered an advantage in Andeden which also discloses the culturing of an algae and recognizes the need for preventing biological contaminants from affecting the culture (see Andeden pg. 223, ¶ 1). The combination would render the instant composition claimed a culture comprising all components claimed.
Claims 2-3 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 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) and in further view of Greatwall (Greatwall, “The “Golden Rule” for Solvent Removal When Using a Rotary Evaporator”, 2018 Nov 27, https://www.greatwall-online.com/news/shownews.php-50.html?lang=en&id=27, accessed 2026 Mar 18, pg. 1).
Andeden’s general disclosure has been set forth above.
Regarding claim 2, Andeden teaches growing a biomass from Auxenochlorella protothecoides microalgae (see pg. 212, ¶ 2), incubating the biomass (see pg. 212, ¶ 3), agitating the biomass via shaking in solvent overnight (see pg. 213, ¶ 3), centrifuging the biomass in solvent to precipitate a pellet (see pg. 214, ¶ 5), separating the supernatant after centrifugation (see pg. 213, ¶ 6), and obtaining an concentration of 10-500 mg/L (see pg. 215, ¶ 5).
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, ¶ 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 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[Symbol font/0xB0]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). 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 ethyl acetate and methanol can both can be used to extract the biomass in Alsenani (see Alsenani pg. 1836, ¶ 1) and Andeden teaches methanol to extract (see Andeden pg. 214, ¶ 6) and so the two solvents can be considered functional equivalents. Therefore, 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[Symbol font/0xB0]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[Symbol font/0xB0]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[Symbol font/0xB0]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 pg. 1). Therefore, it would be reasonable to expect the ordinary artisan to try the 40+/- 5[Symbol font/0xB0]C temperature range as this would be a standard practice in the art.
Regarding claim 3, Andeden teaches using a nitrogen stress medium (see pg. 212, ¶ 2).
Conclusion
No claims were allowed.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.R.W./Examiner, Art Unit 1653
/SHARMILA G LANDAU/ Supervisory Patent Examiner, Art Unit 1653