DETAILED ACTION
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 .
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 8 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 8, at line 2, recites the limitation "the a-linolenic acid". There is insufficient antecedent basis for this limitation in the claim, because claims 6 and 7 (but not claim 1) recite
a-linolenic acid.
Regarding claim 8, at line 2, the parenthetical phrase "(if present)” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Leninger et al (US 2011/0098356 A1).
The instant claims are drawn to a composition comprising amounts of:
docosahexaenoic acid (DHA) and
(ii) a polyunsaturated fatty acid (PUFA).
The components are in the form of a fatty acid or fatty acid ester, or respective salts thereof (claims 1+). The composition may comprise (ii) a ((20-24):4+n-3) omega-3 PUFA (claim 4) and/or further comprise (iii) a-linolenic acid (18:3n-3) (claims 6-8), or palmitic acid (claim 9). Regarding claims 10-13, the product-by-process inferences such as sourcing of the material and express or implied process steps of making are considered to the extent imparting material and structural arrangements of the end-product, because determination of the composition is based on the end-product itself, not its method of production (see MPEP 2113). Additionally, wherein claims 14 and 15 recite, respectively, functional properties without providing the minimal further materials (if any) to perform the effect (antioxidant, stabilizing, surfactant) and an intended therapeutic intended use, the claims remain considered broadly and reasonably inclusive of the materials and intrinsic properties present in DHA and PUFA compositions itself absent a showing of a material difference on new and unexpected, non-obvious property of the instant composition as broadly claimed.
Leninger et al (‘356), however, teaches a composition comprising DHA and a PUFA, and processes thereof, including characterized by:
“…making a polyunsaturated fatty acid ester from polyunsaturated fatty acid triglyceride selected from the group consisting of docosahexaenoic acid, docosapentaenoic acid, arachidonic acid, eicosapentaenoic acid, stearidonic acid, linolenic acid, alpha linolenic acid, gamma linolenic acid, conjugated linolenic acid and mixtures thereof, comprising: a. reacting the triglyceride in the presence of an alcohol and a base to produce an ester of a polyunsaturated fatty acid from the triglycerids; and b. distilling the ester to recover a fraction comprising the ester of the polyunsaturated fatty acid
wherein the triglyceride has not been subjected to one or more treatments selected from the group consisting of refining, desolventization, deodorization, winterization, chill filtration, and bleaching”.
(e.g. see ‘356 at claim 112; as required of instant claims 1+, esp claims 1, 4,6-9,13,15-16).
Leninger also teaches that the material may be in the form of triglycerides containing the PUFAs and “[t]he PUFAs can also be present in any of the common forms found in natural lipids including but not limited to triacylglycerols, diacylglycerols, monoacylglycerols, phospholipids, free fatty acids, or in natural or synthetic derivative forms of these fatty acids (e.g. calcium salts of fatty acids, and the like)” [0096]; that the process may “result in the direct transesterification of triglycerides having PUFA residues to produce esters of the PUFAs” (‘356 at [0131]; see esp. instant claims 1,17); may be sourced from algae, bacteria, fungi and protists [0014]…plants selected from the group consisting of soybean, corn, rice, safflower, sunflower, canola, flax, peanut, mustard, rapeseed, chickpea, cotton, lentil, white clover, olive, palm, borage, evening primrose, linseed and tobacco and mixtures thereof (see ‘356 at para [0015]; emphasis added for clarity; as required of instant claims 10-12). The composition may contain a docosahexaenoic acid:eicoapentataenoic acid ratio (DHA:EPA) of at least 50:1 (as required by instant claims 3-4), Leninger teaching docosahexaenoic acid and eicoapentataenoic acid (20:5, n−3) may be present in the composition and may contain “at least about 92 wt. % or 95 wt. % ethyl ester of docosahexaenoic acid.” and “further comprises less than about 1 wt. %, 0.5 wt. % or 0.25 wt. % eicosapentaenoic acid or an ester thereof” (‘356 e.g. at [0069-0070]). Less than about 1%, and broader teaching in general of inclusion of EPA in the composition, and the teachings of the similar therapeutic, including cardiovascular, effects of the compositions (“may also be used to treat subjects with diseases that can be associated with high levels of triglycerides, such as cardiovascular disease or hypertension” [0145]), then any differences among the portion of non-overlapping amounts are considered merely close amounts, and thus remain obvious variation, subject to mere judicious choice and routine optimization (se MPEP 2144.05). Although the reference does not recite providing palmitic acid per se, the refences does recite providing sourcing from palm (Elaeis sp., the oil of which comprises as a component therein palmitic acid) and thus is broadly and reasonably interpreted as providing an amount thereof. Also, claim 9 recites less than 5% palmitic acid, which remains inclusive of 0% and thus also compositions not containing, and/or silent as to, palmitic acid content.
The composition may be purified and monitored by any process, including as appreciated by Leninger, by distillation, fractional crystallization at low temperatures, urea adduct crystallization, extraction with metal salt solutions, super critical fluid fractionation on countercurrent columns and high performance liquid chromatography (‘356 at [0006]; distillation, chromatography, as required of instant claim 17). The composition is also taught as may be formulated as was known in the art, including “[a]ny biologically acceptable dosage forms, and combinations thereof…” and include, “chewable tablets, quick dissolve tablets, effervescent tablets, reconstitutable powders, elixirs, liquids, solutions, suspensions, emulsions, tablets, multi-layer tablets, bi-layer tablets, capsules, soft gelatin capsules, hard gelatin capsules, caplets, lozenges, chewable lozenges, beads, powders, granules, particles, microparticles, dispersible granules, cachets, douches, suppositories, creams [emulsions], topicals, inhalants, aerosol inhalants, patches, particle inhalants, implants, depot implants, ingestibles, injectables, infusions, health bars, confections, cereals, cereal coatings, foods, nutritive foods, functional foods and combinations thereof. The preparations of the above dosage forms are well known to persons of ordinary skill in the art.” ([0150]; see instant claims 14-15).
It would have been obvious to one of ordinary skill in the art, at the time of the instant invention effective filing date, to have provided a C20-24 omega-3 fatty acid, optionally with amounts of a-linolenic acid (18:3n-3), and/or in the amounts and proportions as instant claimed, because each of the component materials, and their acid, esterification, salts, and transester-ification, by Leninger ’356, including as argued above; and one would have been motivated to have combined based on the teachings of the reference to provide the material combinations and amounts, but the cited reference teaches the same.
Leninger et al ‘356 is relied upon for the reasons discussed above. If not expressly taught therein, based upon the overall beneficial teaching provided by this reference with respect to providing DHA and combinations with other PUFAs and formulations therewith, in the manner disclosed therein and in light of the level of ordinary skill and knowledge of one in the art, the adjustments of particular conventional working conditions (e.g., determining one or more suitable ranges (amounts, proportions, and concentrations) in which to provide such a composition as claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was effective filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
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 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,872,201 (claims 1-20).
Although the claims at issue are not identical, they are not patentably distinct from each other because each of the instant claims and conflicting ‘201 reference patent claims are mutually drawn to A vegetable-based lipid composition comprising: (i) docosahexaenoic acid (22:6n-3) in an amount of at least 86% by weight of the total fatty acid content of the composition; and (ii) a second polyunsaturated fatty acid in an amount of at least about 3% by weight of the total fatty acid content of the composition, wherein the second polyunsaturated fatty acid is the second most abundant polyunsaturated fatty acid in the composition; and wherein the docosahexaenoic acid and the second polyunsaturated fatty acid are each independently provided in the form of a fatty acid, a fatty acid salt, a fatty acid ester or a salt of a fatty acid ester. The instant and reference claims each provide for inclusion of alpha-linolenic acid (instant claims 6-9; ‘201 claims 1+ and 19+), and each set of dependent claims recite similar ranges of and treatment of the composition, such that practicing at least one of the instant or conflicting patent invention as claimed would have at least rendered obvious the other invention as claimed.
Conclusion
No claims are presently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AARON J KOSAR whose telephone number is (571)270-3054. The examiner can normally be reached Mon.-Fri. 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at (571)272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AARON J KOSAR/Primary Examiner, Art Unit 1655
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