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 .
Status of the Claims
Claims 1-15 are pending.
Claim Objections
Claims 7 and 10 are objected to because of the following informalities: claim 7 does not end with a period; and claim 10 should include commas at the ends of lines 2, 3, 4 and 5. Appropriate correction is required.
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.
Claims 2-4, 7, 9-13, and 15 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.
Regarding claims 2-4, 7, 9-10, and 13, the phrases “preferably” and “more preferably” render the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
Claims 11-12 depend from claim 10 and include all the limitations of said claim. The claims do not clarify the type of product being claimed.
Claim 15 depends from claim 13 and includes all the limitations of said claim. The claim does not clarify the instantly claimed ratio of lipids to isolated sunflower oleosomes.
Regarding claim 12, the term “substantially” is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, it is unclear what percentage of lipid is within the scope of “substantially all” of the lipids.
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 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 14-15 are rejected under 35 U.S.C. 101 because the claimed invention is not supported by either a specific and credible asserted utility or a well-established utility.
Claims 14 and 15 recite “Use of the oleosome composition… as a carrier”, but the claims do not recite a statutory category of invention or specific active steps. It is recommended that Applicant amend the claims to recite a method or a process claim reciting the asserted utility and active steps for achieving said utility.
Claims 14-15 are also rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Specifically, because the claimed invention is not supported by either a specific and credible asserted utility or a well-established utility for the reasons set forth above, one skilled in the art clearly would not know how to use the claimed invention.
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.
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.
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.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Billecke et al. (WO 2021/126407 A1).
Regarding claims 1 and 7, Billecke et al. teach a nutritional composition comprising isolated and/or enlarged oleosomes and at least one nutritional ingredient other than isolated and/or enlarged oleosomes and wherein the isolated and/or enlarged oleosomes have an average globule diameter in a range of from 2.0 to 12.0 µm (Claim 1). The at least one nutritional ingredient other than isolated and/or enlarged oleosomes includes essential fatty acids, such as alpha-linolenic acid and docosahexaenoic acid ([0062]-[0063], [0078]). Billecke et al. further teach that at least 40% or more, at least 50% or more, at least 60% or more, at least 70% or more, at least 80% or more, at least 90% or more of the lipid content is present as isolated and/or enlarged oleosomes ([0091]-[0096]; Claims 7-8).
Billecke et al. do not explicitly disclose a nutritional composition comprising isolated sunflower oleosomes loaded with one or more sources of alpha-linolenic acid and/or long-chain polyunsaturated fatty acids, as instantly claimed.
However, Billecke et al. teach that the isolated and/or enlarged oleosomes are preferably obtained from a plant seed, and most preferably from the group of plant species including sunflower ([0020]-[0021], [0055], [0093], [0096], [0097], [0114]-[0128]; Examples 1-4).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare nutritional compositions according to Billecke et al. comprising isolated sunflower oleosomes and at least one nutritional ingredient other than isolated and/or enlarged oleosomes, such as alpha-linolenic acid and docosahexaenoic acid, wherein at least 40% or more, at least 50% or more, at least 60% or more, at least 70% or more, at least 80% or more, at least 90% or more of the lipid content is present as isolated and/or enlarged oleosomes. Such would have been obvious because Billecke et al. teach nutritional compositions comprising isolated oleosomes from sunflower seeds, wherein the nutritional compositions further comprise at least one nutritional agent other than isolated and/or enlarged oleosomes. Further, Billecke et al. teach that suitable nutritional agents include alpha-linolenic acid and docosahexaenoic acid.
Regarding claims 2-5, Billecke et al. teach that the nutritional ingredient may be essential fatty acids, such as alpha-linolenic acid, linoleic acid, docosahexaenoic acid and gamma-linolenic acid, and may also include free fats from vegetable origin, including mono- and poly-unsaturated fatty acids ([0066]-[0068], [0078]).
Therefore, a person of ordinary skill in the art would have been motivated to prepare a nutritional composition according to Billecke et al. comprising free fatty acids and essential fatty acids. A person of ordinary skill in the art would have been able to determine through routine experimentation the optimum concentration of alpha-linolenic acid and docosahexaenoic acid based on the total weight of the fatty acid profile of the oleosome composition.
Regarding claim 6, Billecke et al. teach that the at least one nutritional ingredient other than isolated and/or enlarged oleosomes includes sources of proteins, sources of fats, sources of carbohydrates and/or sources of micronutrients such as, but not limited to, vitamins, minerals, trace elements, essential amino acids or essential fatty acids, wherein the vitamins include carotenoids ([0062]-[0063], [0074], 0085], [0088]; Claim 5).
Regarding claims 8-12, Billecke et al. teach that the nutritional composition includes an infant formula, a composition for elderly people, athletes, or humans having nutritional deficiencies and/or having a deficient immune system, and may be a drink, a powder, a cookie or snack bar, or in any other form ([0010]-[0011], [0083]; Claims 6-8).
Regarding claim 13, Billecke et al. teach a process for preparing the nutritional composition according to any one of the preceding claims, and the process is comprising the blending of the isolated and/or enlarged oleosomes with the at least one other nutritional ingredient other than isolated and/or enlarged oleosomes, and characterized in that the isolated and/or enlarged oleosomes are in powder or liquid form (Claim 9). Billecke et al. further teach that processes for obtaining enlarged oleosomes may include, but are not limited to, a process of applying high-shear centrifugational force to the isolated oleosomes and/ or a process of applying high-shear mixing to the isolated oleosomes ([0033]-[0059], [0106]-[0107]; Example 2).
Regarding claims 14-15, Billecke et al. teach nutritional compositions comprising isolated and/or enlarged oleosomes and at least one nutritional ingredient other than isolated and/or enlarged oleosomes, wherein the at least one nutritional ingredient includes alpha-linolenic acid and docosahexaenoic acid. Therefore, the oleosomes according to Billecke et al. function as a carrier for alpha-linolenic acid and docosahexaenoic acid.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Nitin et al. (US 2018/0296490 A1) in view of Billecke et al. (WO 2021/126407 A1).
Regarding claims 1 and 7, Nitin et al. teach a method of loading one or more bioactive agents into a lipid membrane microcapsule, comprising subjecting the lipid membrane microcapsule in the presence of the one or more bioactive agents to vacuum pressure (Claim 1), and a lipid membrane microcapsule encapsulating or containing at least one hydrophobic bioactive and at least one hydrophilic bioactive (Claim 83). The lipid membrane microcapsule is an oleosome from a plant seed ([0013], [0015]; Claims 50, 111-112), and the bioactive lipid is selected from the group consisting of docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA); alpha-linolenic acid (ALA), omega-6 fatty acids (arachidonic acids), and mixtures thereof ([0013], [0060]; Claim 74). The loading efficiency of the bioactive is at least about 15% ([0013]; Claims 21-22).
Nitin et al. do not explicitly disclose that the oleosome is from a sunflower seed, as instantly claimed.
Billecke et al. teach nutritional compositions comprising isolated and/or enlarged oleosomes and at least one nutritional ingredient other than isolated and/or enlarged oleosomes, wherein the oleosomes may be obtained from sunflower ([0021], [0054], [0093], [0096]-[0097]; Examples 1-4; Claim 4).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare the lipid membrane microcapsule encapsulating or containing a bioactive agent selected from DHA, EPA, ALA and mixtures thereof, as taught by Nitin et al., wherein the lipid membrane microcapsule is sunflower oleosome. Such would have been obvious because Nitin et al. teach that the lipid membrane microcapsule can be an oleosome from a plant seed, and Billecke et al. teach sunflower oleosomes comprising at least one nutritional ingredient other than isolated and/or enlarged oleosomes. Billecke et al. teach that the nutritional ingredient may be essential fatty acids, such as alpha-linolenic acid, linoleic acid, docosahexaenoic acid and gamma-linolenic acid, and may also include free fats from vegetable origin, including mono- and poly-unsaturated fatty acids ([0062]-[0063], [0066]-[0068], [0078]).
Regarding claims 2-5, Nitin et al. teach loading one or more bioactive agents into a lipid membrane microcapsule, wherein the one or more bioactive agents include docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA); alpha-linolenic acid (ALA), omega-6 fatty acids (arachidonic acids), and mixtures thereof, and the lipid membrane microcapsule includes an oleosome from a plant seed.
A person of ordinary skill in the art would have been motivated to prepare a composition according to Nitin et al. comprising plant oleosomes loaded with fatty acids. A person of ordinary skill in the art would have been able to determine through routine experimentation the optimum concentration of docosahexaenoic acid (DHA); eicosapentaenoic acid (EPA); alpha-linolenic acid (ALA), omega-6 fatty acids (arachidonic acids) based on the total weight of the fatty acid profile of the oleosome composition.
Regarding claim 6, Nitin et al. teach that the bioactive includes vitamins, a phytosterol, curcumin, a carotenoid and a flavonoid ([0013], [0031]-[0032], [0059]-[0063]; Claims 63-64, 72-73, 77)
Billecke et al. teach that the at least one nutritional ingredient other than isolated and/or enlarged oleosomes includes sources of proteins, sources of fats, sources of carbohydrates and/or sources of micronutrients such as, but not limited to, vitamins, minerals, trace elements, essential amino acids or essential fatty acids, wherein the vitamins include carotenoids ([0062]-[0063], [0074], 0085], [0088]; Claim 5).
Regarding claims 8-12, Nitin et al. teach compositions comprising the bioactive-loaded lipid membrane microcapsules including edible composition such as a beverage, a food (an infant food, a snack food), a nutraceutical, a compressed cake, a powder, a suspension, or a capsule ([0074]).
Billecke et al. teach that the nutritional composition includes an infant formula, a composition for elderly people, athletes, or humans having nutritional deficiencies and/or having a deficient immune system, and may be a drink, a powder, a cookie or snack bar, or in any other form ([0010]-[0011], [0083]; Claims 6-8).
Regarding claim 13, Nitin et al. do not explicitly disclose high shear force blending to obtain the loaded oleosomes, as instantly claimed.
Billecke et al. teach a process for preparing the nutritional composition according to any one of the preceding claims, and the process is comprising the blending of the isolated and/or enlarged oleosomes with the at least one other nutritional ingredient other than isolated and/or enlarged oleosomes, and characterized in that the isolated and/or enlarged oleosomes are in powder or liquid form (Claim 9). Billecke et al. further teach that processes for obtaining enlarged oleosomes may include, but are not limited to, a process of applying high-shear centrifugational force to the isolated oleosomes and/ or a process of applying high-shear mixing to the isolated oleosomes ([0033]-[0059], [0106]-[0107]; Example 2).
Regarding claims 14-15, Nitin et al. teach a method of loading one or more bioactive agents into a lipid membrane microcapsule, such as an oleosome from a plant seed. Therefore, Nitin et al. teach oleosome compositions as a carrier for the bioactive agents.
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 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 9-16, 18 and 20-25 of copending Application No. 17/785,151 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘151 Application claims a nutritional composition comprising enlarged isolated oleosomes having an average globule diameter in a range of from 3.5 µm to 12 µm, and at least one ingredient other than enlarged isolated oleosomes, wherein the enlarged isolated oleosomes are from a vegetable source. The ‘151 Application further claims that the vegetable source includes sunflower, and the at least one ingredient other than enlarged isolated oleosomes includes essential fatty acids. It is noted that the definition of essential fatty acids according to the ‘151 Application includes alpha-linolenic acid and docosahexaenoic acid. The ‘151 Application claims that the nutritional composition is an infant formula; and further claims a process for preparing the nutritional composition comprising blending the enlarged isolated oleosomes with the at least one other nutritional ingredient.
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to prepare the nutritional composition according to the ‘151 Application wherein the enlarged isolated oleosomes are from sunflowers, and the nutritional composition comprises essential fatty acids, such as alpha-linolenic acid and/or docosahexaenoic acid, as claimed by the ‘151 Application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 19/113,580 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘580 Application claims an oleosome composition comprising loaded isolated vegetable oleosomes, wherein the oleosomes are loaded with one or more sources of LC-PUFA, and the vegetable oleosomes are sunflower oleosomes. The ‘580 Application further claims a product comprising the oleosome composition, and a process for loading the vegetable oleosomes.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-6, 9-16, 18 and 20-25 of copending Application No. 19/166,191 (reference application) in view of Billecke et al. (WO 2021/126407 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘191 Application claims a plant-based oleosomes enriched protein dairy product and a method for preparing the product wherein the plant-based oleosome concentrate comprises isolated oleosomes loaded with one or more sources of linoleic acid (ALA), long-chain polyunsaturated fatty acids (LC-PUFA), and the product is a nutritional composition or drink. The ‘191 Application further claims that at 80 wt.%, preferably at least 90 wt.% or at least 95 wt.% or at least 98 wt.%, of the total weight of lipids in the plant-based oleosome concentrate is present in the oleosomes.
The ‘191 Application does not explicitly claim that the plant-based oleosome is obtained from sunflower.
Billecke et al. teach nutritional compositions comprising isolated and/or enlarged oleosomes and at least one nutritional ingredient other than isolated and/or enlarged oleosomes, wherein the oleosomes may be obtained from sunflower ([0021], [0054], [0093], [0096]-[0097]; Examples 1-4; Claim 4).
It would have been prima facie obvious for a person of ordinary skill in the art prior to the effective filing date of the instant claims to select sunflower oleosomes as the plant-based oleosomes, as reasonably taught by Billecke et al.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nathan W Schlientz whose telephone number is (571)272-9924. The examiner can normally be reached 10:00 AM to 6:00 PM, Monday through Friday.
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, Sue Liu can be reached at (571) 272-5539. 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.
/N.W.S/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
