DETAILED ACTION
Claims 1-15, submitted on November 16, 2023, are pending in the application and are rejected for the reasons set forth below. No claim is allowed.
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 . 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufac-ture, 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 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a composition of nature without significantly more.
The claimed invention is a desalted krill lipid composition that is made from krill starting material. Applicant summarizes the process for manufacturing the composition as follows:
… the present invention further provides processes for the fraction-ation and separation of krill phospholipid concentrates and krill neutral lipid concentrates by controlled fractionation of the desalted krill lipid compositions with an alcohol followed by cryo-centrifugation. The end result is high quality krill phospholipid concentrate compositions comprising from about 50% and up to about 85% phospholipids w/w and krill neutral lipid concentrate compositions with high levels of astaxanthin. Astaxanthin may be further purified from the krill neutral lipid concentrate composi-tions. The krill neutral lipid concentrate compositions of purified astaxanthin may be blended with the krill phospholipid concen-trate compositions to provide krill lipid compositions with desired amount of phospholipids and astaxanthin.
See applicant’s specification at p. 8. The claimed composition is therefore an isolated or purified product of nature. The claimed subject matter is not eligible for a patent for the reasons discussed below.
The Office applies a two-part test to determine patent eligibility. First, the claimed inven-tion must be to one of the four statutory categories as recited in 35 U.S.C. 101, which defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena, including products of nature. For compositions drawn from nature, such as in the present situation, product’s structure, func-tion, or other properties are considered as possible characteristics that may define a patentable invention. See MPEP1 2106 (Patent Subject Matter Eligibility), especially 2106.04(c) (Markedly Different Characteristics Analysis).
The instant claims are drawn to a composition, so it is within the scope of § 101. The composition, however, is merely an isolated or purified phospholipid/triglyceride that does not have markedly different characteristics from the natural product itself. The examiner therefore concludes that the claims are drawn to a judicial exception and are therefore not patent-eligible subject matter.
Claim Rejections – 35 USC § 102/103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alterna-tive, under 35 U.S.C. 103 as obvious over US 2011/0189760 A1 by Yoshikawa et al.
Yoshikawa (cited in applicant’s IDS2) discloses “producing lipids, and especially phospho-lipids, from crustaceans” (para. 0021), including krill (para. 0037). The compositions are desalted by removing “sodium chloride, potassium, and calcium chloride that are contained in bodily fluids and sea water,” which the reference refers to as “ash,” and “it is possible to remove most of the ash by washing with water under conditions by which phospholipids are not dissolved” (para. 0045). The compositions of the reference are therefore “desalted” within the meaning of the instant claims. “The lipids in the lipid-containing solids of [Yoshikawa] contain 50 wt. % or more of phospholipids” (para. 0052), which suggests the phospholipid concentration referred to in instant claim 1. Yoshikawa also provides an example composition (see Example 15 at para. 0087) comprising 44.8% phospholipid, which is further evidence that the reference discloses the phos-pholipid concentration of claim 1. The composition of Example 15 (para. 0086-87) includes trivial amounts of water, ethanol, sodium and astaxanthin, it being implicit that the mass balance comprises the fatty acids of the starting material described in Examples 10-14 (para. 0079-86). This would suggest a triglyceride concentration somewhere around 52%.
The examiner therefore concludes, based upon the above inferences and observations, that Examples 10-15 of Yoshikawa anticipate the claims. When a claim recites ranges, “the claim is ‘anticipated’ if one of them is in the prior art.” See MPEP 2131.03(I) (a specific example in the prior art which is within a claimed range anticipates the range). That appears to be the situation here, namely, that Example 15 anticipates at least claim 1. To the extent that the concentrations disclosed or suggested in the reference do not—strictly speaking—anticipate the instant claims, they are nevertheless close to the claimed ranges. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. … Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” See MPEP 2144.05(I). So, even if the concentrations taught or disclosed by the reference do not specifically meet the limitations of the instant claims, they are nevertheless so close that a prima facie case of obviousness exists.
Properties “a” through “j” appear to be inherent properties of the compositions described in the cited reference. See, generally, MPEP 2112. Yoshikawa discloses a process that is substan-tially the same as that of the instant application. Compare, for example, applicant’s specification at pp. 8-14 with the corresponding disclosure in Yoshikawa at para. 0037-52. Furthermore, Yoshikawa discloses example compositions comprising “trace” quantities of free fatty acids (para. 0056), which appears to be essentially the same thing as limitation “a” of the instant claims. The reference is silent about lysophospholipids, which suggests that their concentrations are essen-tially zero, which would meet limitation “b” of the claims. The amount of sodium in Example 15 (para. 0087) is 0.10%, which suggests limitation “c” of the claims. Further such observations may be made with respect to limitations “d” though “j.” In situations like this, “[w]here applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103.” See MPEP 2112(III) (a rejection under 35 U.S.C. 102 and 103 can be made when the prior art product seems to be identical except that the prior art is silent as to an inherent characteristic). The examiner therefore concludes that the instant claims are unpatentable over Yoshikawa.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alterna-tive, under 35 U.S.C. 103 as obvious over US 2010/0226977 A1 by Tilseth.
Tilseth (cited in applicant’s IDS3) discloses methods of processing “krill to oils comprising phospholipids” (para. 0006) comprising, for example, “about 50% phospholipids w/w” (para. 0016) and “about 35% [or higher] w/w triglycerides” (para. 0028). “[F]ree fatty acids were almost absent” (para. 0076); nitrogen-containing compounds were “preferably less than 1 mg/100 g (dry weight) of trimethylamine (TMA), trimethylamine oxide (TMAO) and/or lysophosphatidyl-choline” (para. 0023); apparently no ethyl esters (or, at least the reference appears to be silent with respect to such compounds); and “less than about … 10, 5, 2 or 1 mg/kg,” i.e., 10, 5, 2, and 1 ppm, respectively, of astaxanthin (para. 0007), which appears to meet at least limitations (a), (b), (d), (g), and (j) of the instant claims. The compositions of the prior art therefore appear to be identical to those of the instant claims, so the burden shifts to applicant to demonstrate a patentable difference, if any. See MPEP 2112(III).
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 possi-ble 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 provi-sions 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 accompa-nied 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 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,456,412 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 9 of the ‘412 Patent is drawn to a method of producing a composition having “a concentrated phospholipid composition comprising from about 50% to about 85% w/w phospholipids and wherein the composition has one or more of the following properties: a triglyceride content of from about 5% to 35% w/w; a free fatty acid content of from about 4% w/w to about 11% w/w; a lysophospholipid content of from about 0.8% w/w to about 7.0% w/w; an inorganic salt content of less than about 0.2% w/w;” and so forth. The phospholipid and triglyceride concentrations of the compositions of this Patent overlap with the corresponding concentrations of the same ingredients of the instant claims, so a prima facie case of obviousness exists. See MPEP 2144.05(I) (“In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”).
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 10,864,223 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘223 Patent is directed to “[a] desalted krill lipid composition comprising: from about 30% to 50% w/w phos-pholipids; from about 32% to 52% w/w triglycerides; and wherein the composition has the following properties: a) the composition comprises less than about 0.2% w/w inorganic salts; b) the composition comprises less than about 2 ppm Cu⁺⁺; and c) the composition comprises less than about 3 ppm total arsenic.” Claim 1 of the ‘233 Patent is within the scope of at least instant claim 1, so they are not patentably distinct.
Claims 1-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,819,509 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The present application is a continuation of the ‘509 Patent. The instant claims are not patentably distinct from the claims of the ‘509 Patent for substantially the same reasons discussed immediately above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The examiner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Exam-iner 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, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
March 4, 2026(revised March 25, 2026)
1 Manual of Patent Examining Procedure (MPEP), Latest Revision November 2024 [R-01.2024]
2 See the IDS submitted on March 24, 2025.
3 See the information disclosure statement (IDS) submitted on November 16, 2023.
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