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 Objections
Claim 20 is objected to because of the following informalities: the claim recites “…10-60% (w/w/) of said starch”. The Examiner suggests deleting the second “/”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-2, 4-14 and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (CN 107969706; published: 5/1/18), as evidenced by Cave et al. (US 2022/0211660; published: 7/7/22).
Liu et al. is directed to nanoscale enteral nutrition preparation (Title).
With regards to instant claims 1-2, 4-14 and 18-19, Liu et al. teach a nutritional preparation comprising the following raw materials in percentage by mass of 15-25% of egg white derived small peptide, 10-15 of soybean derived small peptide, 20-35% of maltodextrin, 5-10% of medium chain triglyceride, 2-5% of olive oil, 1-3% of prebiotics, 0.2-1% of composite vitamins, 5-10% of total dietary fibers, 3-6% of minerals and 3-7% of lecithin (Abstract). As evidenced by Cave et al., lecithin is an example of glycerophospholipid ([0197]; reads on instant claims 4-6). In step 1 of the abovementioned preparation, Liu et al. teach that small peptide liposome nanoparticles are produced with lecithin, egg white-derived small peptides and soybean-derived small peptides (i.e., an agent such as a biomolecule), wherein the embedding rate was 85-96% (p. 4). In step 3, Liu et al. disclose that the composite small peptide liposome nanoparticle further comprises multivitamins and dietary fibers, wherein the multivitamin is composed of vitamin C, D, E and B9 (i.e., folic acid) and the total dietary fiber is composed of oat fiber, resistant starch and pea fiber (p. 4). As indicated in step 3 spray drying of composite small peptide liposome nanoparticle was used to incorporate fibers (which includes oat fiber, pea fiber and resistant starch) and therefore, at least a portion of the fibers must necessarily be located on the outside surface of the liposomes’ phospholipid bilayer.
Therefore, by teaching all the limitations of claims 1-2, 4-14 and 18-19, Liu et al. anticipate the instant invention as claimed.
Claims 1-8, 11 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nannoni et al. (WO 2021/234538; published: 11/25/21; in IDS dated 11/27/25), as evidenced by Cave et al. (US 2022/0211660; published: 7/7/22; in IDS dated 11/27/25).
Nannoni et al. is directed to an active liposome which comprises an active ingredient in a liposome (Abstract).
With regards to instant claims 1-6 and 11, Nannoni et al. teach the process of making an active liposome comprising the active ingredient (e.g., berberine), in a lecithin-based liposome (p. 4, lines 12-13) by (i) preparing a granulating mixture or solution comprising at least one active ingredient and at least one coating agent (phospholipids, phosphoglycerides, sphingophospholipids, lecithin), water and optionally technological additives and/or excipients and then (ii) subjecting it to granulation, optionally, with a granulation aid, and (iii) drying (i.e., substantially free of water) to form the liposome in granular form (p. 6). Nannoni et al. teach that the granular form in a powder and the active liposome has a phospholipid bilayer (p. 8, lines 12-16). As evidenced by Cave et al., lecithin is an example of glycerophospholipid ([0197]; reads on instant claims 4-6).
With regards to instant claims 1, 4-6 and 16-17, Nannoni et al. teach that in step (i), the mixture comprises extract of Berberis aristate, sunflower lecithin and lecithin (p. 9, lines 5-10).
With regards to instant claims 1, 7-8 and 11, Nannoni et al. teach wherein the mixture of step (i) is brought into contact with a granulation aid to obtain a wet granulate, wherein the granulation aid is plant fibers (p. 11, lines 1-10).
Therefore, by teaching all the limitations of claims 1-8, 11 and 16-17, Nannoni et al. anticipate the instant invention as claimed.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2, 4-14 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 107969706; published: 5/1/18), as evidenced by Cave et al. (US 2022/0211660; published: 7/7/22).
As noted in the anticipation rejection above Liu et al. anticipates claims 1-2, 4-14 and 18-19 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103(a) over Liu et al. for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Liu et al. is directed to nanoscale enteral nutrition preparation (Title).
With regards to instant claims 1-2, 4-14 and 18-19, Liu et al. teach a nutritional preparation comprising the following raw materials in percentage by mass of 15-25% of egg white derived small peptide, 10-15 of soybean derived small peptide, 20-35% of maltodextrin, 5-10% of medium chain triglyceride, 2-5% of olive oil, 1-3% of prebiotics, 0.2-1% of composite vitamins, 5-10% of total dietary fibers, 3-6% of minerals and 3-7% of lecithin (Abstract). As evidenced by Cave et al., lecithin is an example of glycerophospholipid ([0197]; reads on instant claims 4-6). In step 1 of the abovementioned preparation, Liu et al. teach that small peptide liposome nanoparticles are produced with lecithin, egg white-derived small peptides and soybean-derived small peptides (i.e., an agent such as a biomolecule), wherein the embedding rate was 85-96% (p. 4). In step 3, Liu et al. disclose that the composite small peptide liposome nanoparticle further comprises multivitamins and dietary fibers, wherein the multivitamin is composed of vitamin C, D, E and B9 (i.e., folic acid) and the total dietary fiber is composed of oat fiber, resistant starch and pea fiber (p. 4). As indicated in step 3 spray drying of composite small peptide liposome nanoparticle was used to incorporate fibers (which includes oat fiber, pea fiber and resistant starch) and therefore, at least a portion of the fibers must necessarily be located on the outside surface of the liposomes’ phospholipid bilayer.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Liu et al. teach a composition comprising 3-7% lecithin and 5-10% fiber (which includes dietary fibers and starch) by mass (Abstract). Liu et al. do not specifically teach wherein the composition comprises 10-40% lecithin or 10-50% starch, as required by instant claim 20.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
The amount of lecithin and starch is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount (% w/w) of lecithin and starch in order to best achieve the desired results as such would provide advantageous biological effect. 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 engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Liu et al. teach that its liposome nanoparticles are made from lecithin and such effectively protect the main nutrient components of the nutrition preparation, which upon administration protects the embedded small peptides from rapid degradation in the gastrointestinal tract (p. 5). Lie et al. teach that the resistant starch that is incorporated into its liposome nanoparticle compositions is a dietary fiber. The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of lecithin and starch would impact the liposomal structures and the dietary action upon administration to a human and therefore be an optimizable variable.
From the teachings of the references, 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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Claims 1-2, 4-15 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 107969706; published: 5/1/18), as evidenced by Cave et al. (US 2022/0211660; published: 7/7/22), and in view of Nakayoshi et al. (JP 2016/169167; published: 9/23/16).
As noted in the anticipation rejection above Liu et al. anticipates claims 1-2, 4-14 and 18-19 and so in anticipating these claims, said claims are also considered obvious under 35 USC 103(a) over Liu et al. for the reasons set forth below ("lack of novelty is the epitome of obviousness" May, 574 F.2d at 1089, 197 USPQ at 607 (citing In re Pearson, 494 F.2d 1399, 1402, 181 USPQ 641, 644 (CCPA 1974))).
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Liu et al. is directed to nanoscale enteral nutrition preparation (Title).
With regards to instant claims 1-2, 4-14 and 18-19, Liu et al. teach a nutritional preparation comprising the following raw materials in percentage by mass of 15-25% of egg white derived small peptide, 10-15 of soybean derived small peptide, 20-35% of maltodextrin, 5-10% of medium chain triglyceride, 2-5% of olive oil, 1-3% of prebiotics, 0.2-1% of composite vitamins, 5-10% of total dietary fibers, 3-6% of minerals and 3-7% of lecithin (Abstract). As evidenced by Cave et al., lecithin is an example of glycerophospholipid ([0197]; reads on instant claims 4-6). In step 1 of the abovementioned preparation, Liu et al. teach that small peptide liposome nanoparticles are produced with lecithin, egg white-derived small peptides and soybean-derived small peptides (i.e., an agent such as a biomolecule), wherein the embedding rate was 85-96% (p. 4). In step 3, Liu et al. disclose that the composite small peptide liposome nanoparticle further comprises multivitamins and dietary fibers, wherein the multivitamin is composed of vitamin C, D, E and B9 (i.e., folic acid) and the total dietary fiber is composed of oat fiber, resistant starch and pea fiber (p. 4). As indicated in step 3 spray drying of composite small peptide liposome nanoparticle was used to incorporate fibers (which includes oat fiber, pea fiber and resistant starch) and therefore, at least a portion of the fibers must necessarily be located on the outside surface of the liposomes’ phospholipid bilayer.
Ascertainment of the Difference Between the Scope of the Prior Art and Claims
(MPEP §2141.012)
Liu et al. do not teach wherein its liposome formulation used as a nutritional supplement further comprises polyphenols, as required by instant claim 15. However, this deficiency is cured by Nakayoshi et al.
Nakayoshi et al. is directed to polyphenol-containing liposome that can provide polyphenol in the form and concentration suitable for the human intestinal absorption (Abstract). Nakayoshi et al. teach that such polyphenols can be, for example, flavonoid polyphenols, phenolic acid polyphenols and lignan polyphenols ([0022]). Nakayoshi et al. that the polyphenol can be used as a xanthine oxidase inhibitor for inhibiting the activity of xanthine oxidase in vivo, or in blood in living organisms such as humans ([0029]). Furthermore, it can function as an active ingredient of a blood uric acid level reducing agent capable of reducing uric acid concentration ([0029]).
Liu et al. teach a composition comprising 3-7% lecithin and 5-10% fiber (which includes dietary fibers and starch) by mass (Abstract). Liu et al. do not specifically teach wherein the composition comprises 10-40% lecithin or 10-50% starch, as required by instant claim 20.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
Liu et al. and Nakayoshi et al. are both directed to liposomal technologies to be consumed by humans to deliver active agents for, for example, nutritional purposes. Based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, before the invention was effectively filed, to modify the liposomes of Liu et al. by further incorporating polyphenols (e.g., flavonoid polyphenols or phenolic acid polyphenols) to achieve the predictable result of obtaining a composition suitable for human consumption and more specifically, for human intestinal absorption. One of ordinary skill in the art would have been motivated to do so because Nakayoshi et al. teach that it is advantageous for inhibiting the activity of xanthine oxidase in vivo, or in blood in living organisms such as humans ([0029]) and for reducing uric acid concentration ([0029]).
The amount of lecithin and starch is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and would reasonably expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount (% w/w) of lecithin and starch in order to best achieve the desired results as such would provide advantageous biological effect. 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 engage in routine experimentation to determine optimal or workable ranges that produce expected results. Where 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, 105 USPQ 233 (CCPA 1955). In the instant case, Liu et al. teach that its liposome nanoparticles are made from lecithin and such effectively protect the main nutrient components of the nutrition preparation, which upon administration protects the embedded small peptides from rapid degradation in the gastrointestinal tract (p. 5). Lie et al. teach that the resistant starch that is incorporated into its liposome nanoparticle compositions is a dietary fiber. The Examiner considers it prima facie obvious to optimize the amounts of any biologically active agent to achieve their known biological effect, absent unexpectedly superior properties of the claimed invention. In the instant case, one of ordinary skill in the art would have recognized that the amounts of lecithin and starch would impact the liposomal structures and the dietary action upon administration to a human and therefore be an optimizable variable.
From the teachings of the references, 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 would have been prima facie obvious to one of ordinary skill in the art before the invention was effectively filed, as evidenced by the references, especially in the absence of evidence to the contrary.
Thus, the claimed invention was prima facie obvious before the effective filing date of the claimed invention.
Conclusion
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/GENEVIEVE S ALLEY/Primary Examiner, Art Unit 1617