DETAILED ACTION
Notice of 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 .
Status of the Claims
The amendments filed 4/21/2026 have been entered.
Response to Arguments
Applicant’s arguments, filed 4/21/2026, have been fully considered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. In particular, the rejection of claims under 35 U.S.C. 112(b), the rejection of claims under 35 U.S.C. 102(a) as being anticipated by Perez (US 2008/0207748), and the rejection of claims under 35 U.S.C. 103(a) as being unpatentable over Perez (US 2008/0207748) in view of Kubala (“The 8 Best Vitamins for Lungs, According to a Dietician” available online at https://www.healthline.com/nutrition/vitamins-for-lungs#bottom-line, 10/20/2021) have been WITHDRAWN in view of Applicant’s amendments to the claims.
The rejection of claims under 35 U.S.C. 103(a) as being unpatentable primarily over Perez (US 2008/0207748) has been modified in view of Applicant’s amendments to the claims, but is otherwise MAINTAINED.
Applicant traverses. Applicant first argues that “Perez does not teach the presently claimed homogeneous high shear liposome vitamin C preparation, nor does Perez teach an amphipathic and amphiphilic molecule component extracted from natural waxes and natural oils” (Applicant Arguments, Page 11).
The argument is not found persuasive. As discussed in the basis of the rejection, Perez teaches that the vitamin C preparation is prepared by charging “[a] jacketed mixer... with dry powder of 58 kg of vitamin C, 0.75 kg of the lipid metabolites... and 1.5 kg of bioflavonoids” after which “[t]he mixer was then turned on (agitation is initiated–plows) to create a homogenous mixture of dry powder” and then “[t]he high speed shearing devices (choppers) were initiated for 1 minute” (Paragraph 0134) – which is understood to provide a homogenous high shear mixture. And, as to the amphipathic and amphiphilic molecule component being extracted from natural waxes and natural oils, Applicant is reminded that product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps (MPEP 2113). As stated by the court in In re Thorpe (777 F.2d 695 (Fed. Cir. 1985), “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claims is the same or obvious from a product of the prior art, the claim is unpatentable even though the prior art product was made by a different process.”
Applicant next argues that “Perez also does not teach the presently required phospholipid, glycerophospholipid, and sphingophospholipid architecture now positively recited in amended Claim 1” and “the additional references [do not] cure these deficiencies” (Applicant Arguments, Page 11). As argued by Applicant, the additional references “generally concern liposomal systems and lipid materials that may be used in liposome formation. However, the fact that certain phospholipid species may be known in liposomal technologies does not teach or suggest Applicant’s presently claimed formulation as a whole” (Applicant Arguments, Page 11).
While it is recognized that the prior art do not disclose a single liposome comprising the exact combination of amphipathic and amphiphilic molecules claimed by Applicant, the prior art teach that phospholipids, glycerophospholipids, and sphingophospholipids – including each of those specifically recited by claim 6 – and virtually limitless combinations thereof are known in the formation of liposomes. And, as indicated by the Court in KSR v. Teleflex (127 S,Ct. 1727 (2007)), “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. Accordingly, when considering the obviousness of a combination of known elements, the operative question is “whether the improvement is more than the predictable use of prior art elements according to their established functions”. Significantly, the Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim [but, instead] can take account of the inferences and creative steps that a person of ordinary skill in the art would employ”, emphasizing that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Consistent with this reasoning, it is MAINTAINED that it would have obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive compositions “yielding no more than one would expect from such an arrangement”.
For all the foregoing reasons, Applicant’s arguments are not found persuasive.
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.
Claims 1, 4-6, 9-17, 21 and 23-25 are rejected under 35 U.S.C. 103(a) as being unpatentable over Perez (US 2008/0207748; of record) in view of Bally et al (US 5,409,704; of record), Tournier et al (US 2007/0196284; of record), Perkins et al (2017/0165374; of record), Alonso-Castro et al (J Food Biochem 46:e14013, January 2022 – Abstract only; of record), Venn-Wilson et al (Sci Rep 10:8161, 2020; of record), Hu et al (J Functional Foods 62:103520, 2019; of record), Singh et al (Micoorganisms 9:2517, 2021; of record), Marangoni et al (Atherosclerosis 292:90-98, 2020; of record) and Lee et al (Lipids in Health and Disease 13:196, 2014; of record).
As amended, claim 1 is drawn to a method for improving the status of a health condition, the method comprising:
(a) identifying the health condition; and
(b) administering a liposome vitamin C preparation comprising a homogenous high shear mixture comprising:
a liposome vitamin C component in an amount of at least 35% by weight based on the total weight of the liposome vitamin C preparation;
an amphipathic and amphiphilic molecule component in an amount of at least 0.1% and at most 65% by weight based on the total weight of the liposome vitamin C preparation, wherein the amphipathic and amphiphilic molecule component:
is extracted from natural waxes and natural oils; and
comprises at least one phospholipid, at least one glycerophospholipid, and at least one sphingophospholipid, more specifically wherein (as recited by claim 6 (and which reads on claims 4-5)) the amphipathic and amphiphilic molecule component comprises 28 ingredients, including (see claim 6 for complete listing):
about 0.02 – 1.0% myristic acid;
about 0.02 – 1.0% pentadecanoic acid;
about 1.0 – 7.0% palmitic acid;
about 0.02 – 1.0% palmitoleic acid;
about 0.02 – 1.0% margaric acid;
about 0.05 – 6.0% stearic acid;
…
about 1.0 – 20.0% Phosphatidylinositol; and
about 0.01 – 5.0% Phosphatidylserine; and
a bioflavonoid component in an amount of at least about 0.1% and at most about 5.0% by weight based on the weight of the liposome vitamin C preparation;
wherein the health condition comprises nervous system health (claim 9); a risk of developing a neurodegenerative disorder (claim 10); neurite outgrowth via NGF mediation (claim 11); wound healing (claim 12); fibroblast adhesion to and the interaction with human extracellular matrices (claim 13); a protection offered by human immune systems against xenobiotics (claim 14); a risk of developing an oxidative pathogenesis (claim 15); a risk of developing cancer (claim 16); a risk of developing a cardiovascular disease (claim 17); a risk of developing atherosclerosis (claim 21); a risk of developing an age-related disease associated with cytotoxic mechanisms (claim 23); a risk of developing an age-related disease associated with genotoxic mechanisms (claim 24); and/or a risk of developing an age-related disease associated with proinflammatory mechanisms (claim 25).
The invention, as summarized, reads on claims 1, 4-6, 9-17, 21 and 23-25.
Perez teaches a method to “(i) promote a healthy nervous system, (ii) prevent or decrease the risk of developing a neurodegenerative disease, (iii) enhance NGF-mediated neurite outgrowth, (iv) promote wound healing, (v) enhance fibroblast adhesion to and the interaction with the extracellular matrix, (vi) protect the immune system from xenobiotics, (vii) decrease the risk of developing an oxidative pathogenesis, (viii) decrease the risk of developing cancer, cardiovascular diseases, atherosclerosis, and other age-related diseases associated with cytotoxic, genotoxic, and proinflammatory mechanisms” (Paragraph 0012), the method comprising:
(a) “recognizing… that the person is in need thereof, and” (Paragraph 0013); and
(b) “after said recognition, orally administering to the human an effective amount of the vitamin C preparation” (Paragraph 0014), wherein the vitamin C preparation is prepared by charging “[a] jacketed mixer... with dry powder of 58 kg of vitamin C, 0.75 kg of the lipid metabolites... and 1.5 kg of bioflavonoids” after which “[t]he mixer was then turned on (agitation is initiated–plows) to create a homogenous mixture of dry powder” and then “[t]he high speed shearing devices (choppers) were initiated for 1 minute” (Paragraph 0134), and wherein the vitamin C preparation comprises (Page 5, Table 1):
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As such, Perez teaches a method for improving the status of a health condition (as recited by claims 1, 9-17, 21 and 23-25) comprising (a) identifying the health condition; and (b) administering a vitamin C preparation comprising a homogenous high shear mixture comprising:
vitamin C in an amount of 90-99% by weight based on the total weight of the preparation (i.e., a vitamin C component in an amount of at least 35% by weight based on the total weight of the preparation);
a lipophilic component comprising palmitic acid, linoleic acid, alpha linoleic acid, oleic acid, etc. in an amount of 0.01-5.0% by weight based on the total weight of the preparation (i.e., an amphipathic and amphiphilic molecule component in an amount of at least 0.1% and at most about 65% by weight based on the total weight of the preparation); and
a bioflavonoid component in an amount of 0.1-5.0% by weight based on the weight of the liposome vitamin C preparation (i.e., a bioflavonoid component in an amount of at least about 0.1% and at most about 5.0% by weight based on the weight of the liposome vitamin C preparation).
As further taught by Perez, the vitamin C preparation is prepared as follows (Paragraph 0134):
“[a] jacketed mixer was charged with dry powder of 58 kg of vitamin C, 0.75 kg of the lipid metabolites prepared above and 1.5 kg of bioflavonoids (AnMar International Ltd; Bridgeport, Conn.). The mixer was then turned on (agitation is initiated–plows) to create a homogenous mixture of dry powder. The high speed shearing devices (choppers) were initiated for 1 minute. Hot water was then pumped through the jacket of the mixer to heat the mixture to 80o C. with continuous mixing (plows only) for 15 minutes for complete encapsulation. The encapsulated mixture was cooled by running chilled water (10 o C.) through the jacket under continuous mixing for 1 hour until a free-flowing powder was formed. The powder was discharged into a double polyethylene-lined container and then passed through a comminuting mill running at approximately 2500 rpm equipped with a 0.15 mm screen. The milled powder was collected into appropriately labeled, double polyethylene-lined drums and reconciled”
Significantly, the preparation of the “vitamin C preparation” taught by Perez is virtually identical to the preparation of the instantly claimed “liposome vitamin C preparation” (instant Specification, Page 32, Example 1), as follows:
“[a] jacketed mixer was charged with dry powder of 50 kg of vitamin C, 75 kg of the amphipathic and amphiphilic prepared above and 5 kg of bioflavonoids. The mixer was then turned on (agitation is initiated–plows) to create a homogenous high shear mixture of dry powder. The highspeed shearing devices (choppers) were initiated for 1 minute. Hot water was then pumped through the jacket of the mixer to heat the mixture to 80oC with continuous mixing (plows only) for 15 minutes for complete liposome encapsulation. The liposome encapsulated mixture was cooled by running chilled water (10oC) through the jacket under continuous mixing for 1 hour until a free-flowing powder was formed. The powder was discharged into a double polyethylene-lined container and then passed through a comminuting mill running at approximately 2500 rpm equipped with a 0.15 mm screen. The milled powder was collected into appropriately labeled, double polyethylene-lined drums and reconciled”
As such, it is asserted, absent evidence to the contrary, that the encapsulated vitamin C preparation of Perez is a liposome vitamin C preparation as claimed. As stated in In re Best, Bolton, and Shaw, 562 F2d 1252 (CCPA 1977), “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product” (see also In re Fitzgerald 619 F2d 67 (CCPA 1980): the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on”).
In the instant case, the claimed and prior art products are substantially identical and are produced by substantially identical processes.
Accordingly, the method of Perez differs from the instantly claimed method in the following ways:
Perez does not teach the inclusion of at least one phospholipid, at least one glycerophospholipid, and at least one sphingophospholipid, in particular phosphatidylcholine, 1-lysophosphatidylcholine, 2-lysophosphatidylcholine, phosphatidylethanolamine, lyso-phosphatidylethanolamine, N-Acyl-phosphatidylethanolamine (NAPE), phosphatidylinositol, phosphatidylserine, phosphatidic acid, lyso-phosphatidic acid, phosphatidylglycerole, and diphosphatidylglycerole in amounts as recited by claim 6; and
Perez does not teach the inclusion of myristic acid, pentadecanoic acid, palmitoleic acid, margaric acid, vaccenic acid, linolenic acid, and gondoic acid in amounts as recited by claim 6.
Yet, as to (I): phospholipids, glycerophospholipids, and sphingophospholipids – including each of those specifically recited by claim 6 – are known in the formation of liposomes.
For example, Bally et al teaches liposomes for drug delivery comprising “phospholipids such as phosphatidylinositol, phosphatidylcholine, phosphatidylethanolamine, phosphatidylserine and phosphatidylglycerol alone or in combination with other lipids” (Column 3, Lines 9-12), further teaching that “preferred amphipathic compounds are phosphoglycerides, representative examples of which include phosphatidylcholine, phosphatidylethanolamine, lysophosphatidylcholine, lysophosphatidylethanolamine, phosphatidylserine, phosphatidylinositol, phosphatidic acid… diphosphatidylglycerol… [as well as] members of the sphingolipid and glycososphingolipid families” (Column 5, Lines 51-66).
Similarly, Tournier et al teach “[p]referred materials for forming liposomes are phospholipids, optionally in admixture with other amphiphilic compounds” (Paragraph 0031) such as “phosphatidylcholines… phosphatidylserines… phosphatidylglycerols… phosphatidylethanolamines… phosphatidylinositol” as well as “lysophospholipids” (Paragraph 0032), “phosphatidic acids… sphingolipids such as sphingomyelin” (Paragraph 0033), phosphatidylglycerol… lysophopsphatidic acid” and the like (Paragraph 0043).
And Perkins et al teach liposomes for drug delivery comprising N-Acyl-phosphatidylethanolamine (NAPE) (Paragraph 0055).
Collectively, the prior art teach that phospholipids, glycerophospholipids, and sphingophospholipids – including each of those specifically recited by claim 6 – and combinations thereof are known in the formation of liposomes.
Accordingly, it would have been prima facie obvious to formulate liposomes based on Perez in view of Gopi comprising phospholipids, glycerophospholipids, and sphingophospholipids – including each of those specifically recited by claim 6. As indicated by the Court in KSR v. Teleflex (127 S,Ct. 1727 (2007)), “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”.
And, in doing so, it would have been prima facie obvious to determine the amount of each of said phospholipids, glycerophospholipids, and sphingophospholipids – including each of those specifically recited by claim 6 – to include therein. As stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
And, as to (II): myristic acid, pentadecanoic acid, palmitoleic acid, margaric acid (heptadecanoic acid), vaccenic acid, linolenic acid, and gondoic acid are known to offer health benefits.
For example, Alonso-Castro et al teach “anti-inflammatory activities of MA [myristic acid]” (Abstract).
Venn-Wilson et al teach that “pentadecanoic acid (C15:0) and heptadecanoic acid (C17:0) are associated with lower risks of cardiometabolic diseases, and higher dietary intake… is associated with lower mortality” (Abstract).
Hu et al teach that “[p]almitoleic acid has reported to generate numerous beneficial biological functions, especially its ability to increase insulin sensitivity and to reduce the risk of diabetes” and “is an important compound that is widely applied in many fields, including health [and] pharmaceutics” (Page 11, Column 1).
Singh et al teach that “[v]accenic acid (VA)… has been shown to have hypolipidemic effects” (Abstract) and “diet supplemented with beef enriched with VA has a mild insulin sensitizing effect while raising plasma HDL cholesterol” (Page 15).
Marangoni et al teach that “the large majority of experimental and clinical studies have assessed the potential benefit of increasing dietary intake of LA [linoleic acid]” and data “suggest an association between high dietary intakes… of… specifically LA, and the improvement of cardiovascular risk… as well as long-term glycemic control and insulin resistance” (Abstract).
And, Lee et al teach that administration of “PUFA-containing oils” – comprising gondoic acid, as well as myristic, palmitoleic, and vaccenic acids and the like (Page 6, Table 3) – “improved biomarkers associated with T2D/metabolic syndrome” (Abstract).
Accordingly, it would have been prima facie obvious to formulate liposomes based on Perez in view of Gopi further comprising myristic acid, pentadecanoic acid, palmitoleic acid, margaric acid (heptadecanoic acid), vaccenic acid, linolenic acid, and gondoic acid. As indicated by the Court in KSR v. Teleflex (127 S,Ct. 1727 (2007)), “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”.
And, in doing so, it would have been prima facie obvious to determine the amount of each of said myristic acid, pentadecanoic acid, palmitoleic acid, margaric acid (heptadecanoic acid), vaccenic acid, linolenic acid, and gondoic acid to include therein. As stated by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454 (CCPA): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
Accordingly, claims 1, 4-6, 9-17, 21 and 23-25 are anticipated.
Claims 18-20 and 22 are rejected under 35 U.S.C. 103(a) as being unpatentable over Perez (US 2008/0207748; of record) in view of Bally et al (US 5,409,704; of record), Tournier et al (US 2007/0196284; of record), Perkins et al (2017/0165374; of record), Alonso-Castro et al (J Food Biochem 46:e14013, January 2022 – Abstract only; of record), Venn-Wilson et al (Sci Rep 10:8161, 2020; of record), Hu et al (J Functional Foods 62:103520, 2019; of record), Singh et al (Micoorganisms 9:2517, 2021; of record), Marangoni et al (Atherosclerosis 292:90-98, 2020; of record) and Lee et al (Lipids in Health and Disease 13:196, 2014; of record), as applied to 1, 4-6, 9-17, 21 and 23-25 above, in further view of Kubala (“The 8 Best Vitamins for Lungs, According to a Dietician” available online at https://www.healthline.com/nutrition/vitamins-for-lungs#bottom-line, 10/20/2021; of record).
Claims 18-20 and 22 are drawn to the method of claim 1, wherein the health condition comprises a risk of developing respiratory infections (claim 18), a risk of developing pulmonary diseases (claim 19), a risk of developing lung infections (claim 20), and/or a risk of developing respiratory diseases (claim 22).
As taught by Kubala, “[v]itamin C functions as a power antioxidant, meaning it works to prevent cellular damage. It also has anti-inflammatory and immune-modulating properties, and studies show that having optimal vitamin C levels is essential for healthy lungs”. Additionally, Kubala teach that “[s]tudies show that supplemental vitamin C may reduce the risk and duration of respiratory infections. It may also help improve lung function and prevent lung function decline in people with asthma”.
Accordingly, based further on Kubala, it would have been prima facie obvious to extend the method above to the treatment of a patient having a health condition comprising a risk of developing respiratory infections, a risk of developing pulmonary diseases, a risk of developing lung infections, and/or a risk of developing respiratory diseases, with a reasonable expectation of success.
As such, claims 18-20 and 22 are rejected as prima facie obvious.
Conclusion
Any new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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