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 .
DETAILED ACTION
Response to Amendment
Status of the Claims
Receipt of Applicant’s response, filed 21 Nov 2025 has been entered.
Claims 1-4, 6-9, 12, 13, 17, 19, 21-25, 30, 31, 32, 53, 61, 84, 95 and 97 remain pending in the application.
Claims 1, 2, 7, 9, 12, 13, 17, 19, 21, 23, 30, 32, 53, 61, and 84 are amended.
Claims 5, 10, 11, 14-16, 18, 20, 26-29, 33-52, 54-60, 62-83, 85-94 and 96 are canceled.
Claims 23-25, 30, 31, 53, 84 and 95 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Claim 95 is withdrawn as it requires medicaments alternative to the elected fish oil.
Claims 1-4, 6-9, 12, 13, 17, 19, 21, 22, 32, 61 and 97 are under consideration to the extent of the elected species, i.e., that the reducing sugar is dextrose and the lipid-soluble medicament is fish oil.
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, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows: in the prior-filed applications, Application No. 63/199,438, the applicant failed to provide adequate written description support for claim 8. Accordingly, priority cannot be granted at this time, thus claim 8 is granted the filing date of application PCT/US21/65358 (12/28/2021).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 63/199,438 , fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application ‘438 fails to provide support for the alcohol of ethanol as in claim 8. Accordingly, claim 8 is not entitled to the benefit of the prior application.
Response to Arguments
Applicant's arguments filed 21 Nov 2025 have been fully considered but they are not persuasive. Applicant states that one skilled in the art would know how to make and use suitable alcohol extracted phospholipids without undue experimentations. The applicant points to “an alcohol, such as methanol” in [0044] of the ‘438 application as providing support for ethanol as one of ordinary skill would understand ethanol is a conventional alcohol and “an alcohol” and methanol are merely illustrative. The examiner is not persuaded by this and notes that entitlement to a filing date does not extend to subject matter, which is not disclosed, but would be obvious over what is expressly disclosed. Lockwood v. American Airlines Inc., 41 USPQ2d 1961 (Fed. Cir. 1977). Even if one of ordinary skill may recognize ethanol as an obvious alcohol for the method, this does not establish possession of the obvious species of ethanol for the instant application.
Objections Withdrawn
Objections to the Claims
The claim objections set forth in the Non-Final Office Action mailed 22 Sep 2025 are hereby withdrawn in light of applicant’s amendments of the claims.
Rejections Withdrawn
Rejections Pursuant to 35 USC § 112
The rejections of claims 1-4, 6-9, 12, 13, 17, 19, 21, 22, 32 and 61 pursuant to 35 U.S.C. 112(b) set forth in the Non-Final Office Action mailed 22 Sep 2025 are hereby withdrawn in light of applicants amendment of the claims.
Rejections Maintained
The rejections below were made previously and are made again with modification to address the new claim amendments and new claim 97.
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.
Claim interpretation
Claims 1, 32, and 61 recite “stopping the reaction before the intermediate stage of the Maillard reaction.” In light of the instant specification, this limitation that the reaction is stopped before the intermediate stage is not understood to require that no intermediate stage product may be formed but it rather is open to allowing a portion of the produce to include intermediate stage product. The instant specification at [0048] states that “As used in the present invention, the Maillardd reaction is stopped before the intermediate stage. That is, the process runs through completion of the Amadori rearrangement but is stopped before significant Strecker degradation. As a result, the majority of the product of the Maillard reaction (e.g. 60% or more) may be 1-amino-1-deoxy-2-ketose.” Thus, in light of the specification, “stopping the reaction before the intermediate stage” is understood to allow for a portion of the reaction to proceed beyond Amadori rearrangements.
Claims 1-4, 9, 12, 13, 17, 19, 32, 61 and 97 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman et al. (US 2011/0020519, published 27 Jan 2011) in view of Russi et al. (US 2018/0338990, published 29 Nov 2018).
Bowman teaches the encapsulation of materials that are sensitive to oxidation ([0002]). Bowman teaches encapsulated materials include at least an oxidation sensitive prilled core containing at least one oxidatively unstable material and at least one phytosterol and at least one protective shell layer surrounding the core ([0007]). Bowman teaches various oxidatively unstable materials that may be used in the core such as PUFAs and fat soluble vitamins ([0033]), and teaches that exemplary PUFAs include those found in fish oil ([0035]) rendering obvious the lipid-soluble material of PUFA, lipid-soluble vitamin and lipid-soluble medicament of claims 1, 32 and 61. Bowman teaches that the core may include ingredients having limited or no susceptibility to oxidation such as phospholipids and micelle stabilizers ([0040]) and teaches phospholipids for forming a shell (Table 2) and teaches exemplary micelle stabilizers such as phosphatidylcholine and phosphatidylethanolamine ([0040]). The inclusion of a phospholipid shell and micelle stabilizers such as phosphatidylcholine and phosphatidylethanolamine renders obvious lipid emulsifying agents having at least one amino groups and the phospholipids as in instant claims 1, 3, 32 and 61. As it is obvious to include individual phospholipids as noted above, this renders obvious the “emulsifying agent purity of at least 95 wt%” as in the instant claims. It would be obvious to use the components as taught by Bowman and to have them at them at a high purity so they can serve their intended purpose. Bowman teaches additional components such as lecithins as microencapsulating materials to form protective shell layers ([0043]) and that an exemplary phospholipid material is deoiled lecithin ([0040]) rendering obvious the lecithin of claim 4. Bowman teaches that the materials provide a barrier to oxygen, water, light or other oxidation promoters ([0043]), which renders obvious the limitation of claim 19 that the coating enhances or lengthens the shelf life. The protective shell layer may be covered by one or more additional layers such as a water-dispersible oxygen-barrier layer, hydrocolloid layer, or lipophilic layer ([0044]) and the layers form a shell surrounding the core ([0045]). Bowman teaches that the layers may be reacted with a Maillard reaction ([0049]). Bowman teaches the inclusion of dextrose as a reducible sugar for the Maillard reaction (Table 2), rendering obvious the reducing carbohydrate source of the instant claims. Bowman teaches that the various layers and their ingredients and relative amounts may be varied to provide materials having a variety of properties ([0053]) rendering it obvious to adjust the amount of each component in order to determine the optimal properties of the encapsulated material. Bowman teaches an example composition where the core was 80 parts by weight, the carbohydrate was 40 parts by weight and the lipophilic shell what 240 parts by weight (Table 3 Example C). The core consists of the oxidatively unstable materials discussed above ([0040]) and thus corresponds to the lipid soluble material of the claims. The lipophilic shell is understood to correspond to the phospholipid shell and the lipid emulsifying agent of the claims. The carbohydrate shell may be dextrose, as noted above, and corresponds to the reducing carbohydrate source of the claims. Example C noted above thus renders obvious claim 2 where the reducing carbohydrate source is less than the emulsifying agent and less than the lipid-soluble material as the carbohydrate is less than the core and lipophilic shell. The carbohydrate to lipophilic shell ratio in example C is 40:240 (20:120) and alternative examples A and B have ratios of 120:240 (20:40) and 80:240 (20:60) respectively. The range of carbohydrate to lipophilic shell components demonstrated in the examples (which overlaps with the claimed range of 20:80 in claim 17) and the teaching that the relative amounts of the components may be varied to achieve different properties renders obvious the range in claim 17.
While Bowman renders obvious the micelle-encapsulated lipid-soluble material of the instant claims, Bowman does not teach the specific method steps regarding the Maillard reaction as recited in the instant claims. This deficiency is made up for in the teachings of Russi.
Russi teaches the preparation of rumen protected carbohydrates using a Maillard reaction conducted by heating under less than atmospheric pressure, i.e. under a vacuum ([0006]). Russi teaches heating for a sufficient amount of time, at a sufficient temperature and under reduced pressure in the presence of sufficient moisture so that a Maillard reaction product is formed ([0010]). Russi teaches heating to a temperature between about 60 °C and 90 °C at a pressure between 0.4 atm to about 0.7 atm ([0014]) and for a time of 7 min to about 120 min ([0015]). It is noted that this pressure, temperature and time overlap with the pressure, temperature and time parameters of claims 9 and 13. Russi additionally teaches that the weight % of the reducing carbohydrate source versus the nitrogen source in the reaction may be present at various ratios such as about 10:90, 20:80 or 30:70 ([0049]) further rendering obvious the claimed ratio of carbohydrate to emulsifying agent as described above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have encapsulated materials sensitive to oxidation using a Maillard reaction by heating to a temperature between about 60 °C and 90 °C at a pressure between 0.4 atm to about 0.7 atm and for a time of 7 min to about 120 min. The encapsulation of materials sensitive to oxidation in protective layers by using a Maillard reaction is known from the teachings of Bowman, however, the specific parameters on how to perform the Maillard reaction are not taught by Bowman. The parameters regarding the pressure, temperature, moisture and time for conducting a Maillard reaction to protect molecules is known from Russi. It thus would have been obvious to one of ordinary skill to use the parameters for the Maillard reaction taught by Russi for forming the encapsulated material taught by Bowman as these are standard parameters for employing the Maillard reaction to form protection around substances. There would be a reasonable expectation of success in using these parameters as they are known as suitable for completing a Maillard reaction.
Regarding the limitation that the Maillard reaction is stopped the intermediate stage and claim 97 where teh reaction is stopped when the majority is 1-amino-1-deoxy-2-ketoses and before more than 20% of the reaction product is overcooked Strecker degradation product, the examiner notes that this limitation is met from the obviousness of the Maillard reaction parameters taught by Russi. The necessary parameters for completing the Maillard reaction, such as the temperature, pressure and time are known and are consistent with the parameters of the claims. It is not necessary that the art specifically teach the goal of stopping before the intermediate stage as this would be met from following the Maillard reaction parameters taught by Russi as these parameters dictate the processing procedure for the reaction.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Response to Arguments
Applicant's arguments filed 21 Nov 2025 have been fully considered but they are not persuasive. Applicant states that Bowman fails to disclose or suggest forming a Maillard product shell without adding protein to the mixture and that this is in contrast to the currently amended claim 1 where the need to add a protein to the mixture is eliminated (page 11 of remarks). Applicant argues similarly against the teachings of Russi by stating that Russi fails to disclose a Maillard shell without adding protein to the mixture (page 11 of remarks). The applicant notes that Bowman and Russi rely on protein as an essential component for forming the Maillard shell whereas amended claim 1 relies on a lipid emulsifying agent (page 12 of remarks). The examiner is not persuaded by these arguments as the claims are open to the presence of proteins and do not exclude proteins. The claims use the transitional phrase comprising which is inclusive or open-ended and does not exclude additional, unrecited elements or method steps (see MPEP 2111.03(I)). For example, the claims recite “said method comprising” and “a source of lipid-soluble material that comprises a polyunsaturated fatty acid (PUFA), a lipid-soluble vitamin, a lipid-soluble nutrient compound, or a mixture of two or more thereof.” The mixing step of the claims where the lipid-soluble material is mixed with the reducing carbohydrate and a lipid emulsifying agent is understood in light of these transitional phrases and there is nothing in the claim that would prevent the inclusion of a protein into the mixture. The components required per the claim are obvious from the art and the claims are open to the addition of the other components such as a protein and thus the addition of a protein as suggested by the applicant does not render the claims as non-obvious in view of the art. The applicant may desire to amend the claim to align with their invention by using a closed transitional phrase such as “consisting of” which could exclude the presence of unrecited compounds such as proteins.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman et al. (US 2011/0020519, published 27 Jan 2011) in view of Russi et al. (US 2018/0338990, published 29 Nov 2018), as applied to claims 1-4, 9, 12, 13, 17, 19, 32, 61 and 97 above and further in view of Maynes (US 2004/0161520, published 19 Aug 2004, listed on IDS filed 06/29/2023).
The teachings of Bowman and Russi are described supra. Bowman and Russi do not teach de-oiling by solvent extraction with ethanol. These deficiencies are made up for in the teachings of Maynes.
Maynes teaches ethanol and water extraction of oil and sugar from crude lecthin while retaining phospholipids in the lecithin ([0003]). Maynes teaches that acetone is known for use in lecithin extraction but that it induces products that impact the organoleptic quality of the oil and causes a musty hay-like odor and a sharp pungent aftertaste in products produced therefrom ([0015]). Maynes teaches that extraction with ethanol/water avoids the use of extraction solvents that impair the flavor or color of lecithin products ([0017]). Maynes teaches an oil and sugar content of 10% or less ([0022]) and that the process achieves an improved lecithin product with a high phospholipid content ([0024]). Maynes teaches the steps include providing crude lecithin and mixing with a blend of ethanol and water to extract oil and sugar and mixing the residual a second time with a blend of ethanol and water to extract sugar ([0027]). These steps are the same as the further extraction steps with ethanol to remove residual sugars as in claims 6-8.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have used lecithin de-oiled by solvent extraction as a phospholipid material in the encapsulation method rendered obvious by Bowman and Russi and to have further extracted with ethanol to remove residual sugars. Deoiled lecithin is known as a suitable phospholipid material from Bowman. The specific process of de-oiling and removing sugars from lecithin by solvent extraction with ethanol is known from the teachings of Maynes. It is further known that extraction with ethanol avoids adding unwanted flavor or color to the lecithin products. Thus, it would have been obvious to use lecithin that had undergone solvent extraction with ethanol as this is a suitable method for improving the quality of crude lecithin by increasing phospholipid content and does not add unwanted flavors or color and it would be desirable to use lecithin with higher phospholipid content with the absence of unwanted colors and odors.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Bowman et al. (US 2011/0020519, published 27 Jan 2011) in view of Russi et al. (US 2018/0338990, published 29 Nov 2018), as applied to claims 1-4, 9, 12, 13, 17, 19, 32, 61, and 97 above and further in view of Subramanian et al. (US 8,221,809, published 17 Jul 2012) and Celli et al. (US 2020/0154727, published May 21, 2020, filed 18 Nov 2019).
The teachings of Bowman and Russi are described supra. Bowman and Russi do not teach using an extruder with degassing section and vacuum cooking and drying. These deficiencies are made up for in the teachings of Subramanian and Celli.
Subramanian teaches the need for protecting labile compounds such as PUFAs and vitamins from oxygen and other substances as they are sensitive and may lose biological or other desired activity when unprotected (col 1 lines 20-40). Subramanian teaches the use of the Maillard reaction for forming reaction products (col 2 lines 58-65) and teaches forming products by extrusion (col 5 lines 60-66). Subramanian teaches that if water content is high that dewatering may be done with techniques well known in the art such as vacuum tray drying (col 14 lines 39-50), rendering obvious a process of vacuum cooking and drying.
Celli teaches that an extruder provides high-process shearing, impacting, friction and temperature which facilitates a higher intensity degree of the Maillard reaction ([0307]). Celli teaches a twin barrel extruder may include a vacuum degassing port system for degassing and volatilization ([0312]) and that the equipment may have a secondary vacuum sizing system further facilitating the control of the end-process reaction ([0313]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have performed the Maillard reaction in an extruder with a degassing port system and to have dried the product with a technique such as vacuum tray drying. Conducting a Maillard reaction through an extrusion process with an extruder is known to increase the degree of the Maillard reaction from the teachings of Subramanian and Celli. It further is known from Celli that vacuum degassing may be used with an extruder and that this helps control the end process reaction. Thus, it would have been obvious to use an extruder with degassing as this is a suitable technique for performing Maillard reactions and offers high intensity and high control. It further would be obvious to use dry the product with a well known process such as vacuum tray drying as this is a known means of lowering high water content, as taught by Subramanian, and one would desire to remove excess moisture from the encapsulated product of oxidatively sensitive compounds in order to increase the protection against undesired oxidation or degradation.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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 1-4, 6-9, 12, 13, 17, 19, 21, 22, 32, 61 and 97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,389,418 in view of Bowman et al. (US 2011/0020519, published 27 Jan 2011), Maynes (US 2004/0161520, published 19 Aug 2004, listed on IDS filed 06/29/2023), Subramanian et al. (US 8,221,809, published 17 Jul 2012) and Celli et al. (US 2020/0154727, published May 21, 2020, filed 18 Nov 2019).
The ‘418 patent recites:
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The method parameters for the Maillard reaction are the same parameters of the instant claims and would result in stopping before the intermediate stage of the Maillard reaction and before more than 20% of the reaction product is overcooked Strecker degradation product.
The ‘418 patent differs from the instant claims by not reciting the inclusion of a lipid-soluble vitamin, 95% purity, extraction with ethanol, that the coating enhances shelf life of the PUFA, an extruder and vacuum cooking and drying. These deficiencies are made up for in the teachings of Bowman, Maynes, Subramanian and Celli.
The teachings of Bowman, Maynes, Subramanian and Celli are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a vitamin, a high purity lecithin extracted with ethanol, and where the product is formed in an extruder and undergoes vacuum drying. Encapsulating oxidatively sensitive compounds such as PUFA and vitamins using a Maillard reaction is known from Bowman and ethanol is a suitable solvent for extraction of crude lecithin, as taught by Maynes. As it is known that lecithin is a mixture of components and that it can be purified, it would be desirable to attain lecithin with a high level of purity of phospholipids to enhance the Maillard reaction. Using extrusion with degassing and removing water with vacuum tray drying are obvious process steps, as taught by Subramanian and Celli and one would have a reasonable expectation of success with these techniques as they are known for use with Maillard reaction products and are well known in the art. The product formed from the Maillard reaction would provide enhanced shelf life the oxidatively sensitive compounds.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art.
Claims 1-4, 6-9, 12, 13, 17, 19, 21, 22, 32, 61 and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 12,496,286 (previously rejected as copending Application No. 17/810,934) in view of Bowman et al. (US 2011/0020519, published 27 Jan 2011), Maynes (US 2004/0161520, published 19 Aug 2004, listed on IDS filed 06/29/2023), Subramanian et al. (US 8,221,809, published 17 Jul 2012) and Celli et al. (US 2020/0154727, published May 21, 2020, filed 18 Nov 2019).
The ‘286 patent recites a PUFA supplement prepared by mixing a reducing carbohydrate such as dextrose with de-oiled lecithin with a PUFA where the weight of carbohydrate is less than the lecithin and PUFA, and the product may have fat-soluble vitamins or other lipophilic nutrients and the product undergoes a Maillard reaction under sufficient moisture for about 7-240 min from about 30°C-135°C and a pressure between 0.4-0.7 atm and the carbohydrate to lecithin is about 20:80.
The method parameters for the Maillard reaction are the same parameters of the instant claims and would result in stopping before the intermediate stage of the Maillard reaction and before more than 20% of the reaction product is overcooked Strecker degradation product.
The ‘286 patent differs from the instant claims by not reciting 95% purity, extraction with ethanol, that the coating enhances shelf life of the PUFA, an extruder and vacuum cooking and drying. These deficiencies are made up for in the teachings of Bowman, Maynes, Subramanian and Celli.
The teachings of Bowman, Maynes, Subramanian and Celli are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have a high purity lecithin extracted with ethanol, and where the product is formed in an extruder and undergoes vacuum drying. Encapsulating oxidatively sensitive compounds such as PUFA and vitamins using a Maillard reaction is known from Bowman and ethanol is a suitable solvent for extraction of crude lecithin, as taught by Maynes. As it is known that lecithin is a mixture of components and that it can be purified, it would be desirable to attain lecithin with a high level of purity of phospholipids to enhance the Maillard reaction. Using extrusion with degassing and removing water with vacuum tray drying are obvious process steps, as taught by Subramanian and Celli and one would have a reasonable expectation of success with these techniques as they are known for use with Maillard reaction products and are well known in the art. The product formed from the Maillard reaction would provide enhanced shelf life the oxidatively sensitive compounds.
This is a provisional nonstatutory double patenting rejection.
Claims 1-4, 6-9, 12, 13, 17, 19, 21, 22, 32, 61 and 97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/048,215 in view of Bowman et al. (US 2011/0020519, published 27 Jan 2011), Maynes (US 2004/0161520, published 19 Aug 2004, listed on IDS filed 06/29/2023), Subramanian et al. (US 8,221,809, published 17 Jul 2012) and Celli et al. (US 2020/0154727, published May 21, 2020, filed 18 Nov 2019).
The ‘215 application recites a method of preparing a supplement by mixing a reducing carbohydrate such as dextrose with de-oiled lecithin with a lipid soluble fraction nutritional supplement where the weight of carbohydrate is less than the lecithin and lipid-soluble fraction such as a PUFA, and the product undergoes a Maillard reaction under sufficient moisture for about 7-240 min from about 30°C-135°C and a pressure between 0.4-0.7 atm and the carbohydrate to lecithin is about 20:80 and the lecithin is extracted with alcohol.
The method parameters for the Maillard reaction are the same parameters of the instant claims and would result in stopping before the intermediate stage of the Maillard reaction and before more than 20% of the reaction product is overcooked Strecker degradation product.
The ‘215 application differs from the instant claims by not reciting a lipid soluble vitamin, 95% purity, extraction with ethanol, that the coating enhances shelf life of the PUFA, an extruder and vacuum cooking and drying. These deficiencies are made up for in the teachings of Bowman, Maynes, Subramanian and Celli.
The teachings of Bowman, Maynes, Subramanian and Celli are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a vitamin and a high purity lecithin extracted with ethanol, and where the product is formed in an extruder and undergoes vacuum drying. Encapsulating oxidatively sensitive compounds such as PUFA and vitamins using a Maillard reaction is known from Bowman and ethanol is a suitable solvent for extraction of crude lecithin, as taught by Maynes. As it is known that lecithin is a mixture of components and that it can be purified, it would be desirable to attain lecithin with a high level of purity of phospholipids to enhance the Maillard reaction. Using extrusion with degassing and removing water with vacuum tray drying are obvious process steps, as taught by Subramanian and Celli and one would have a reasonable expectation of success with these techniques as they are known for use with Maillard reaction products and are well known in the art. The product formed from the Maillard reaction would provide enhanced shelf life the oxidatively sensitive compounds.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 21 Nov 2025 have been fully considered but they are not persuasive. The applicant requests the examiner to hold the double patenting rejections in abeyance. The examiner notes that a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600