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 .
Claims 37-56 are currently pending and under examination.
This application is a divisional of U.S. Application No. 17/533,771 filed November 23, 2021, now U.S. Patent No. 12,146,180, which is a divisional of U.S. Application No. 15/845,697 filed December 18, 2017, now U.S. Patent No. 11,198,891, which claims priority to U.S. Provisional Application No. 62/437,886, filed December 22, 2016.
While this Application was filed as a divisional application, it is noted that the elected, examined, and allowed group of parent Application No. 15/845,697 was also directed to the culture. As such, the culture as claimed in the current application is not directed to a previously non-elected group. Therefore, this application will be treated as a continuation application for the purposes of double patenting with Application No. 15/845,697.
Claim Objections
Claims 49 and 50 are objected to because of the following informalities: microorganism “have” a biomass productivity, should instead read microorganism “has” a biomass productivity. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 51 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The invention appears to employ novel biological materials, specifically the eukaryotic microorganism having IDAC Accession No. IDAC Accession No. 220716-01. Since the biological materials are essential to the claimed invention they must be obtainable by a repeatable method set forth in the specification or otherwise readily available to the public. If the biological materials are not so obtainable or available, the requirements of 35 U.S.C. § 112 may be satisfied by a deposit of the biological materials.
If the deposit is made under the Budapest Treaty, then an affidavit or declaration by Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the specific biological materials have been deposited under the Budapest Treaty and that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 C.F.R. §§ 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that:
(a) during the pendency of this application, access to the invention will be afforded to
the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon
granting of the patent;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5
years after the last request or for the effective life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit will be made
(see 37 C.F.R. § 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
Applicant's attention is directed to M.P.E.P. §2400 in general, and specifically to §2411.05, as well as to 37 C.F.R. § 1.809(d), wherein it is set forth that "the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited material sufficient to specifically identify it and to permit examination." The specification should be amended to include this information, however, Applicant is cautioned to avoid the entry of new matter into the specification by adding any other information.
Although Applicants have noted on page 5, lines 19-29 of the Specification that the biological material was deposited according to the Treaty of Budapest, a statement that the biological materials will be irrevocably and without restriction or condition released to the public upon the issuance of a patent is additionally required.
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 54 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 pre-AIA the applicant regards as the invention.
Claim 54 recites the limitation "the whole algae biomass" in line 2. There is insufficient antecedent basis for this limitation in the claim. No whole algae biomass is previously recited in the claims.
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 37-56 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recite a culture comprising a microorganism and culture medium, which is a natural product. This judicial exception is not integrated into a practical application because only a culture comprising a microorganism and culture medium is claimed. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because only a culture comprising a microorganism and culture medium is claimed.
It is noted that the 2019 Revised Patent Subject Matter Eligibility Guidance, published January 2019, is being followed and referred to in this rejection.
With regard to Step 1, the culture as claimed in claims 37-56 is a composition of matter.
With regard to Step 2A, prong one, Claim 37 encompasses a culture that includes: a) a lipid-producing eukaryotic microorganism with a 18S sequence having 100% identity to the sequence set forth in SEQ ID NO: 1; and b) a heterotrophic medium, where the medium provides the result of the eukaryotic microorganism having a lipid profile comprising 1% to 55% docosahexaenoic acid (C22:6n-3, DHA), 7% to 20% docosapentaenoic acid n-6 (C22:5n-6, DPAn6), 0.001% to 3.0% arachidonic acid (C20:4n-6, ARA), and 0.001% to 1.0% heptadecanoic acid (C17:0) by weight of total fatty acids. Thus, claim 37 is generally directed to a culture comprising a microorganism and culture medium. Applicant indicates that the microorganism as claimed has distinguishing features over wild type microorganisms in their natural environment, where the natural environments are aquatic environments including oceanic, freshwater, and brackish environments, where these environments are not considered to be encompassed by the term heterotrophic medium (Spec., p. 5, Line 30 to p. 6, line 2).
However, Seo et al. (Art of Record: IDS; US 2013/0089901, Published 2013) teach the Thraustochytrid-like microalgae strain KRS101, which is a natural microorganism isolated from soil in a mangrove area in Malaysia and contains a high concentration of DHA, where the strain KRS101 is a lipid-producing eukaryotic microorganism with an 18S sequence, wherein the 18S sequence is very similar (98.1%) to instant SEQ ID NO: 1 (Seo et al.: Abs.; SEQ ID NO: 1; Para. 8, 11, 56). The lipid-producing eukaryotic microorganism as claimed is also a Thraustochytrid-like strain (see Spec. Example 1; Strain G3-1). As such, the microorganism encompassed by claim 1a) is deemed to be simply isolated from nature, and as such is a natural product.
With regard to the heterotrophic medium of claim 1b), while Applicant indicates that natural aquatic environments are not considered a “heterotrophic medium” as claimed, Applicant then defines “heterotrophic medium” broadly as media including a carbon source and a nitrogen source (see Spec., p. 5, line 31 to p. 6, line 2; 10, Line 23-24). Aquatic environments, which support the growth of the microorganism of claim 1a) inherently contain carbon and nitrogen, and thus must be considered a “heterotrophic medium.” Additionally, as Seo et al. teach that the Thraustochytrid-like microalgae strain KRS101 is isolated from soil, soil, which supports the growth of the microorganism, inherently contains carbon and nitrogen, and thus is also a “heterotrophic medium.” The further limitation that the medium provides the result of the eukaryotic microorganism having a lipid profile as claimed is a result that naturally flows from bringing the microorganism and heterotrophic medium into contact.
Therefore, both the microorganism of a) and the heterotrophic medium of 1b), which together are the culture of claim 1, are natural products. Additionally, the overall culture as claimed can be found in nature, for example, the Thraustochytrid-like microalgae strain KRS101 in soil from a mangrove area, and thus the overall culture appears to also be as a whole, a natural product.
With regard to Step 2a, prong two, claim 37 does not recite any elements in addition to the culture comprising the microorganism of a) and the heterotrophic medium of b). As such, there is no additional element in claim 1 that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a culture to produce LCFAs, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
With regard to Step 2b, claim 1 does not recite any elements in addition to the culture comprising the microorganism of a) and the heterotrophic medium of b). As such, the claim does not recite additional elements that alone or together amount to significantly more than the judicial exception itself.
With regard to dependent claims 38-56, it is noted that these claims each recite only results that further characterize bringing together the microorganism of claim 1a) with the heterotrophic medium of 1b), in culture. As such, claims 38-56 are not deemed to provide additional limitations that would render the claimed subject matter eligible.
Therefore, for the forgoing reasons claims 37-56 are not deemed to encompass patent eligible subject matter under 35 USC §101.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 37-56 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,198,891. Although the claims at issue are not identical, they are not patentably distinct from each other because both encompass a culture comprise: (a) a lipid-producing eukaryotic microorganism with an 18S sequence, wherein the 18S sequence has 100% identity to the sequence set forth in SEQ ID NO: 1; and (b) a heterotrophic medium that results in the lipid-producing eukaryotic microorganism having a lipid profile comprising triglycerides and wherein greater than 95% of the triglycerides are comprised of long chain fatty acids including myristic acid (C14:0), palmitic acid (C16:0), docosapentaenoic acid n-6 (C22:5n-6, DPAn6), and docosahexaenoic acid (C22:6n-3, DHA), which encompasses 1% to 55% and 35%-55% docosahexaenoic acid (C22:6n-3, DHA) and 7% to 20% docosapentaenoic acid n-6 (C22:5n-6, DPAn6); and arachidonic acid (C20:4n-6, ARA) and heptadecanoic acid (C17:0), including at less than 3%, which encompasses 0.001% to 3.0% arachidonic acid (C20:4n-6, ARA) and 0.001% to 1.0% heptadecanoic acid (C17:0); and includes a ratio of DHA to DPAn6 of between 3:1 and 7:1 (Present claim: 37, 40, 42-44; Cited patent claim: 1, 2, 4, 8).
The lipid profile comprises less than 3% of each of lauric acid (C12:0), pentadecanoic acid (C15:0, margaric acid), palmitoleic acid (C16:1), stearic acid (C18:0), vaccenic acid (C18:1n-7), oleic acid (C18:1n-9), γ-linolenic acid (C18:3n-6), α-linolenic acid (C18:3n-3), stearidonic acid (C18:4), arachidic acid (C20:0), dihomo-γ-linolenic acid (C20:3n-6), behenic acid (C22:0), docosatetraenoic acid (C22:4), docosapentaenoic acid n3 (C22:5n-3, DPAn3), and lignoceric acid (C24:0) by weight of total fatty acids (Present claim: 38; Cited patent claim: 2). The lipid profile comprises by weight of total fatty acids 0% to 0.02% short chain fatty acids; 10% to 30% palmitic acid (a saturated fatty acid); less than 3%, which encompasses amounts within 0.5% to 5% eicosapentaenoic acid (C20:5n-3, EPA) (Present claim: 39, 41, 45-47; Cited patent claim: 3, 9, 10).
The heterotrophic medium contains less than 3.75 g/L chloride (Present claim: 48; Cited patent claim: 1-12, no chloride is recited as being required in the medium). The lipid-producing eukaryotic microorganism is capable of having a biomass productivity of greater than 0.65 g/L/h, and a triglyceride productivity of greater than 0.3 g/L/h (Present claim: 49, 50; Cited patent claim: 1). The lipid-producing eukaryotic microorganism comprises the eukaryotic microorganism having IDAC Accession No. IDAC Accession No. 220716-01 (Present claim: 51; Cited patent claim: 1, see Col. 4, line 15-20). The heterotrophic medium results in production of one or more carotenoids, including β-carotene, and wherein the β-carotene comprises at least 95% of total carotenoids. (Present claim: 52, 53; Cited patent claim: 11, 12). The heterotrophic medium results in production of at least 20% protein in the whole algae biomass, results in production of 20% to 40% protein of the biomass, and results in production of at least about 40% protein (Present claim: 54-56; Cited patent claim: 1, 5-7).
Conclusion
No claims are allowable.
Art of Record:
Hong et al., IDS, Production of Lipids Containing High Levels of Docosahexaenoic Acid by a Newly Isolated Microalga, Aurantiochytrium sp. KRS101, Appl Biochem Biotechnol, (2011) 164:1468-1480 (culture including novel oleaginous Aurantiochytrium sp. strain KRS101 (lipid-producing eukaryotic microorganism with an 18S sequence, wherein the 18S sequence has at least 98% identity, to instant SEQ ID NO: 1) together with heterotrophic media that provides the result of KRS101 having a lipid profile comprising LCFAs, including high levels of DHA).
Seo et al., IDS, US 2013/0089901, Published 2013 (Thraustochytrid-like microalgae strain KRS101 which is a lipid-producing eukaryotic microorganism with an 18S sequence having 98.1% with SEQ ID NO: 1, and is a natural microorganism isolated from soil in a mangrove area in Malaysia and contains a high concentration of DHA).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER M.H. TICHY whose telephone number is (571)272-3274. The examiner can normally be reached Monday-Thursday, 9:00am-7:00pm ET.
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/JENNIFER M.H. TICHY/Primary Examiner, Art Unit 1653
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