NON-FINAL REJECTION
This application, filed Sep. 22, 2023, is a continuation of 18/160,286, filed Jan. 26, 2023, claims benefit of priority to provisional applications 63/303,365, filed Jan. 26, 2022; 63/303,383, filed Jan. 26, 2022; 63/304,042, filed Jan. 28, 2022; 63/334,065, filed Apr. 22, 2022; 63/334,071, filed Apr. 22, 2022; 63/340,292, filed May 10, 2022; 63/340,304, filed May 10, 2022; 63/342,509, filed May 16, 2022; and 63/348,908, filed Jun. 3, 2022.
Claims 1-4, 18-21, 23-32, 53, and 68, as amended, are pending.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on Feb. 15, 2024 and Feb. 5, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to compositions; eicosapenta-enoic acid ethyl ester (EtEPA) as the PUFA species, lecithin as the source of phospholipid, and polysorbate 80 as the emulsifier, in the reply filed on Jun. 3, 2026 is acknowledged.
Claims 4, 30-32, and 68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Jun. 3, 2026.
Claims 1-3, 18-21, 23-29, and 53 are currently pending and under consideration.
Claim Rejections - 35 U.S.C. § 112(b) – Indefiniteness
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 1-3, 21, and 23-29 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.
Independent claim 1 is drawn to a composition comprising (a) one or more polyunsaturated fatty acids (PUFAs) or derivatives thereof; and (b) a source of phospholipid.
The specification defines a “derivative” of a PUFA to include molecules where the acyl group or the carbon chain portion of the molecule has one or more modifications (para. [0078]).
While the specification discloses many examples of PUFAs and derivatives thereof (e.g., at paras. [0079]-[0100]), “derivative” is an ambiguous term which renders the scope of the claims indefinite, because the disclosure does not provide a limiting definition of the term, which has no clear, commonly understood definition in the art.
The number of potential derivatives and the nature of the steps required to obtain them have no clear boundary. Because the term “derivative” encompasses thousands of unspecified structural variants, a skilled artisan cannot readily ascertain which derivatives are included in the claims, and which are excluded.
Compounds encompassed by the term “derivative” cannot be clearly distinguished from compounds excluded from the scope of the claims. Thus, infringing compositions cannot be distinguished from non-infringing compositions, rendering the metes and bounds of the claims indefinite.
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.
1. Claims 1-3, 18, 19, 21, 23, 24, 29, and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujii et al. (US Pub. 2012/0065264, cited on PTO-892).
Fujii et al. exemplify the compositions of Example 6 and Example 9 (p. 11),
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which comprise
the elected polyunsaturated fatty acid (PUFA), EPA-E (eicosapentaenoate ethyl ester);
the elected source of phospholipid, lecithin; and
the elected emulsifier, polyoxyethylene (20) sorbitan monooleate (a.k.a. polysorbate 80),
as recited by claims 1-3, 18, 19, 23, 24, 29, and 53.
The composition comprises eicosapentaenoic acid ethyl ester as the sole PUFA, and thus contains no more than 20% by weight of any other PUFAs present in the composition, as recited by claim 21.
While the compositions of Fujii et al. are not explicitly disclosed as lymph-releasing compositions, as recited by claim 53, products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
2. Claims 1-3, 18, 19, 23, 24, 27, 28, and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu et al. (CN 105533266 (A), cited on PTO-892).
Lu et al. exemplify a feed additive composition comprising by weight 18 parts DHA ethyl ester oil, 8 parts EPA ethyl ester oil, and 8 parts soybean lecithin (Example 1, para. [0029]).
Thus, the composition of Example 1 of Lu et al. comprises (a) the elected polyunsatu-rated fatty acid (PUFA), eicosapentaenoic acid ethyl ester (EtEPA), and (b) the elected source of phospholipid, lecithin, as recited by claims 1, 3, 18, 19, 23, 24, and 53.
The composition of Example 1 of Lu et al. further comprises 3 parts glycerol phospha-tidylcholine, an emulsifier, as recited by claim 2.
The weight ratio of the DHA ethyl ester oil and EPA ethyl ester oil (18 parts + 8 parts) to the lecithin (8 parts) is 26: 8 or 3.25:1, which falls within the range of about 5:1 to about 1:5, as recited by claim 27.
The weight ratio of the EPA ethyl ester oil (8 parts) to the lecithin (8 parts) is 1:1, which falls within the range of about 1:1 to about 1:5, as recited by claim 28.
While the compositions of Lu et al. are not explicitly disclosed as lymph-releasing compositions, as recited by claim 53, products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
3. Claims 1, 3, 18, 19, 23-26 and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MacFarlane (US Pub. 2007/0082111), as evidenced by Epikuron® 100G Product Information Sheet (both cited on PTO-892).
MacFarlane et al. exemplify a composition comprising the following ethyl ester concentrates of polyunsaturated fatty acids (PUFAs) (para. [0026]; Example 1):
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wherein the major component is C20:5 N-3, i.e., eicosapentaenoic acid ethyl ester (EtEPA).
MacFarlane further exemplifies the composition of Example 4, which comprises the composition of Example 1 plus 250 ppm solid lecithin (Epikuron®, Lucas Meyer) (para. [0032]).
Thus, MacFarlane exemplifies a composition comprising (a) the elected polyunsaturated fatty acid (PUFA), eicosapentaenoic acid ethyl ester (EtEPA), and (b) the elected source of phospholipid, lecithin, as recited by claims 1, 3, 18, 19, 23, 24, and 53.
MacFarlane discloses that Epikuron® 100G is one of two examples of preferred lecithins
(para. 0015]), which is presumed to be the lecithin of Example 4.
As evidenced by the Epikuron® 100G Product Information Sheet (p. 1), the phospholipid profile of Epikuron® 100G comprises:
(a) 20%-27%, by weight, phosphatidylcholine;
(b) maximum 4%, by weight, lysophosphatidylcholine;
(c) 17%-22%, by weight, phosphatidylethanolamine;
(d) 12%-18%, by weight, phosphatidylinositol; and
(e) 2%-9%, by weight, phosphatidic acid,
each of which falls within the ranges recited by claims 25-26.
While the compositions of MacFarlane are not explicitly disclosed as lymph-releasing compositions, as recited by claim 53, products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
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.
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 1-3, 18-21, 23, 24, 29, and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Fujii et al. (US Pub. 2012/0065264, cited on PTO-892).
Fujii et al. exemplify the compositions of Example 6 and Example 9 (p. 11),
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which comprise
the elected polyunsaturated fatty acid (PUFA), EPA-E (eicosapentaenoate ethyl ester);
the elected source of phospholipid, lecithin; and
the elected emulsifier, polyoxyethylene (20) sorbitan monooleate (a.k.a. polysorbate 80),
as recited by claims 1-3, 18, 19, 23, 24, 29, and 53.
The compositions of Examples 6 and 9 comprise eicosapentaenoic acid ethyl ester as the sole PUFA, and thus contain no more than 20% by weight of all PUFAs present in the composition, as recited by claim 21.
The compositions of Examples 6 and 9 comprise eicosapentaenoic acid ethyl ester as the sole PUFA, and thus contain at least 96% by weight of all PUFAs present in the composition, as recited by claim 20.
Fujii et al. further exemplify Preparation Examples 3 and 4, wherein the self-emulsifying
compositions of Examples 6 and 9, respectively, are encapsulated in a soft gelatin capsule in an amount comprising 200 mg EPA-E, (paras. [0144]-[0145]).
The capsules of Fujii et al. differ from the claims in that they comprise 200 mg EPA-E, rather than about 500 mg to about 1 g, as recited by claim 20.
However, Fujii et al. disclose that the composition may be administered at a dose in terms of the EPA-E of most preferably from 0.6 to 0.9 g/day (i.e., 600 mg to 900 mg/day) in 1 to 3 divided doses (para. [0100]).
Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to adjust the amount of EPA-E in the capsules exemplified by Fujii et al. to arrive at the claimed compositions with a reasonable expectation of success, because Fujii et al. explicitly disclose, teach, and suggest minor variations in the EPA-E dosage per capsule that overlap the range recited by claim 20.
Further, as recognized by MPEP § 2144.05,
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
While the compositions of Fujii et al. are not explicitly disclosed as lymph-releasing compositions, as recited by claim 53, products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
USPN 9,889,108; USPN 10,441,560; US Pub. 2017/0119720; and WO 2010/106076 (all cited on PTO-892).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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