DETAILED ACTION
Status of the Application
Claims 16-39 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A preliminary amendment filed on 12/09/2024 cancelling claims 1-15 and adding new claims 16-39, amending the abstract and amending the specification is acknowledged.
Priority
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.LU502240, filed on
06/09/2022. The instant application is a 371 national stage application of PCT/EP2023/065461
filled on 06/09/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/09/2024 is acknowledged.
The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the
information disclosure statements are being considered by the examiner.
Claim Objections
Claim 22-25 and 37-38 are objected to because of the following informalities:
Claims 22 and 23 are objected to in the recitation of “Yarrowia lipolytica”. The genus and species are not italicized in the claim. Appropriate correction is required.
Claims 24 and 25 are objected to in the recitation of “Schizochytrium limacinum”. The genus and species are not italicized in the claim. Appropriate correction is required.
Claims 37 and 38 are objected to in the recitation of “Schizochytrium limacinum”. The genus and species are not italicized in the claim. Appropriate correction is required.
Claims 37 and 38 are objected to in the recitation of “Yarrowia lipolytica”. The genus and species are not italicized in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) Written Description
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.
Claim 23 is 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.
Claim 23 is directed in part to the method of claim 22, wherein the yeast is a “genetically modified variant of the Yarrowia lipolytica species”. As drafted, claim 23 encompasses a broad genus of organisms that are distinct from a reference Y. lipolytica organism, including variants of Yarrowia lipolytica that have one or more genetic modification.
The specification as originally filed does not reasonably convey to a person of ordinary skill in the art that the inventor had possession of the full scope of this claimed genus as of the filing date. In particular, the specification identifies only Yarrowia lipolytica Af4. The specification does not provide a representative number of variants spanning the claimed scope or establish a known or disclosed correlation between any relevant modification and the claimed production of polyunsaturated hydrocarbons. Thus, the disclosure does not identify which organisms qualify as a “genetically modified variant of the Yarrowia lipolytica” beyond the single disclosed example, or demonstrate that the inventor possessed variants across the breadth encompassed by the claim.
Accordingly, a person of ordinary skill in the art would not recognize from the originally filed disclosure that the inventor possessed the full claimed subject matter, including the genus “a genetically modified variant of the Yarrowia lipolytica species”. Claim 23 therefore lacks adequate written description.
Claim Rejections - 35 USC § 112(b)
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 16-32, 34-35 and 37-38 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 16 (claims 17-32 depending therefrom) is indefinite in the recitation of “especially”. It is unclear if the method following is a required limitation. Correction is required.
Claim 24 is indefinite in the recitation of “preferably Schizochytrium limacinum SR21”. The term “preferably” renders the scope of the claimed microbe unclear because it is uncertain whether Schizochytrium limacinum SR21 is a required limitation of the claim or instead merely a non-limiting preferred example within the broader recited genus Schizochytrium. Thus, it is unclear whether the claim encompasses all of the genus Schizochytrium or only Schizochytrium limacinum SR21. Correction is required.
Claim 34 (claim 35 depending therefrom) is indefinite in the recitation of “preferably microalgae”. The term “preferably” renders the scope of the claimed microbe unclear because it is uncertain whether “microalgae” is a required limitation of the claim or instead merely a non-limiting preferred example of marine protists. Thus, it is unclear whether the claim encompasses all marine protists or only microalgae. Correction is required.
Claim 34 (claim 35 depending therefrom) is indefinite in the recitation of “especially”. It is unclear if the method following is a required limitation. Correction is required.
Claim 37 (claim 38 depending therefrom) is indefinite in the recitation of “preferably Schizochytrium limacinum SR21”. The term “preferably” renders the scope of the claimed microbe unclear because it is uncertain whether Schizochytrium limacinum SR21 is a required limitation of the claim or instead merely a non-limiting preferred example within the broader recited genus Schizochytrium. Thus, it is unclear whether the claim encompasses all of the genus Schizochytrium or only Schizochytrium limacinum SR21. Correction is required.
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.
Claims 33-39 are rejected under 35 U.S.C. 101 because the claims are directed to biomass comprising polyunsaturated hydrocarbons, microorganisms, Schizochytrium limacinum SR21 and/or Yarrowia lipolytica, which are all naturally occurring.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16-21 and 24-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel et al. (Chemical Engineering Journal, published online 12/03/2021, NPL #2 in IDS filed on 12/09/2024).
Claim 16 is directed in part to a method of processing a separation product containing carboxylic acids from a separation method, especially a method of separating fish oil and/or algal oil, comprising the step of producing polyunsaturated hydrocarbons at least from some of the carboxylic acids using microbes. Claim 17 is directed to the method claim 16, wherein the polyunsaturated hydrocarbons are or comprise at least one of omega-3 fatty acids and omega-6 fatty acids. Claim 18 is directed to the method of claim 17, wherein the polyunsaturated hydrocarbons are EPA, DHA and/or DPA. Claim 19 is directed to the method of claim 16, wherein the microbes are or comprise at least one of yeast, fungi, bacteria and protists. Claim 20 is directed to the method according to claim 19, wherein the microbes are marine protists. Claim 21 is directed to the method according to claim 20, wherein the microbes are microalgae. Claim 24 is directed to the method of claim 20, wherein the marine protist is a microalga of the Schizochytrium species, preferably Schizochytrium limacinum SR21. Claim 25 is directed to the method of claim 24, wherein the marine protist is Schizochytrium limacinum SR21. Claim 26 is directed to the method of claim 16, wherein the product is a waste product of an industrial separation method. Claim 27 is directed to the method of claim 26, wherein the product is a waste product of a distillation method or a chromatography method. Claim 28 is directed to the method of claim 16, further including adding lipases for improving production by the microbes. Claim 29 is directed to the method of claim 26, further including adding the separation product to a reactor together with the microbes and optionally lipases for producing the polyunsaturated hydrocarbons. Claim 30 is directed to the method of claim 16, wherein the microbes form a biomass and the biomass is processed to give a food or a pharmaceutical ingredient. Claim 31 is directed to the method of claim 30, including feeding the food to aquatic lifeforms intended for production of fish oil. Claim 32 is directed to the method of claim 16, including extracting the polyunsaturated hydrocarbons from biomass formed by the microbes. Claim 33 is directed to a biomass produced from microbes, the biomass comprising polyunsaturated hydrocarbons. Claim 34 is directed to the biomass of claim 33, wherein the biomass includes yeast, fungi, bacteria and/or protists, especially marine protists, preferably microalgae. Claim 35 is directed to the biomass of claim 34, wherein the biomass includes marine protists. Claim 36 is directed to the biomass of claim 35, wherein the biomass includes microalgae. Claim 37 is directed to the biomass of claim 33, wherein the biomass includes yeast of the Yarrowia lipolytica species and/or the marine protist of the Schizochytrium species, preferably Schizochytrium limacinum SR21. Claim 38 is directed to the biomass of claim 37, wherein the biomass includes Schizochytrium limacinum SR21.
Patel et al. teaches a method of recycling marine hydrophobic waste (fish oil) into DHA using Aurantiochytrium (Schizochytrium) limacinum SR21, a marine eukaryotic protist, specifically a thraustochytrid (see pg. 3, left column, third paragraph and pg. 17, 3.8. Proposed process to recycle marine hydrophobic waste into DHA). Patel et al. teaches that Yarrowia lipolytica has been investigated for fatty acid acquisition from the environment (see pg. 6, right column). Patel et al. teaches that lipids extracted from strain SR21 were separated by TLC (Thin Layer Chromatography) (see pg. 17, 3.7. Extraction of squalene from SR21 cultivated on different hydrophilic and hydrophobic substrates). Patel et al. teaches that protein ID: 145,138 was discovered to be a lipase/phospholipase capable of hydrolyzing triacylglycerol and phosphatidylcholine and used in the medium and knocking down the 145,138 gene in A. limacinum inhibited extracellular lipid degradation (see pg. 6, right column). Patel et al. teaches that the A. limacinum SR21 were cultivated in a 3-L bioreactor (see pg. 9, Figure 6). Patel et al. teaches A. limacinum SR21 forming a biomass that produces DHA (see pg. 5, Figure 2). Therefore, Patel et al. anticipates claims 16-21 and 24-38 as written/interpreted.
Claims 22-23 and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xue et al. (Nature Biotechnology, published 07/21/2013).
Claim 22 is directed to the method according to claim 19, wherein the yeast is a yeast of the Yarrowia lipolytica species. Claim 23 is directed to the method according to claim 22, wherein the yeast is a genetically modified variant of the Yarrowia lipolytica species. Claim 39 is directed to the biomass of claim 33, wherein the biomass has an EPA and/or DHA content of at least 5 mg/g of cell dry weight.
Xue et al. teaches engineering Y. lipolytica for commercial production of EPA. Xue et al. teaches that the engineered strain produced lipids with EPA at 56.6% of the total fatty acids by weight and accumulated lipids at up to 30 % of the dry cell weight (DCW), which is 169.8 mg EPA/g DCW (see math below). Xue et al. teaches lipid separation via TLC (see Figure 6). Xue et al. teaches extracting lipids including EPA from biomass of Y. lipolytica strain Y4305 (see pg. 738, right column, first paragraph). Therefore, Xue et al. anticipates claims 22-23 and 39 as written/interpreted.
Total lipids per gram of biomass:
L
i
p
i
d
s
=
30
%
o
f
D
C
W
=
0.3
g
l
i
p
i
d
s
1
g
D
C
W
EPA weight per gram of biomass:
E
P
A
=
56.6
%
o
f
t
o
t
a
l
l
i
p
i
d
s
=
0.3
g
×
0.566
=
0.1698
g
E
P
A
1
g
D
C
W
=
169.8
m
g
E
P
A
1
g
D
C
W
Conclusion
No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALTON KIEFER, PhD whose telephone number is (571)272-1235. The examiner can normally be reached M-F 7:30-5 EST.
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, Robert Mondesi can be reached at (408)918-7584. 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.
/DALTON EDWARD KIEFER/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652
Prosecution Insights