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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 112 –
Indefiniteness, Indefinite Language, Lack of Antecedent Basis
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1-8 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 lack of antecedent basis, claim 1 recites the limitation "the product" in line one. There is insufficient antecedent basis for this limitation in the claim. The Examiner recommends amendment of claim 1 with “a product”; and, amendment with claims 2-8 with “the product”.
Regarding indefinite language, and in claim 2, the phrases "generally” and “optimally" render the claim indefinite, because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Further regarding lack of antecedent basis, claim 4 recites the limitation "the formula" in line one. There is insufficient antecedent basis for this limitation in the claim.
Further regarding lack of antecedent basis, claims 5 and 6 recite the limitation "encapsulation" in line two. There is insufficient antecedent basis for this limitation in the claim.
Regarding indefiniteness, claim 4 is confusing and unclear. It is unclear as to if and when glutathione is claimed, and under what circumstances. The claim does not define what is meant by “history”, “additional testing” and “symptoms”. This is renders the claim vague, broad, and unclear. The Examiner recommends amending claim 1 with an optional limitation of glutathione; and, further limiting claim 4 to wherein the glutathione is not included in the product.
Further regarding indefiniteness, claims 5-6, which depend from claim 1, recite before liposomal encapsulation (of curcumin, claim 5; and of resveratrol, claim 6). Claim 1 recites liposomal curcumin and liposomal resveratrol. The Examiner notes that liposomal curcumin and liposomal resveratrol does not necessarily mean that the ingredients are encapsulated, since active agents can be associated with liposomes through means other than encapsulation. If the Applicant wishes to claim encapsulated active agents, then the Examiner recommends amendment of claim 1, where support exists in the originally filed disclosure, with liposomal encapsulated active agents.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-2 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Yedgar et al (US 2014/0199241 A1), in view of Roy et al (USP 8,945,623 B2), both in view of Marshall et al (US 2021/0228663 A1) and Tanaka et al (US 2023/0302040 A1), further in view of McGavern et al (US 2015/0011626 A1), both in view of Sordillo et al (US 2020/0360300 A1) and Wdowin et al (US 2018/0200216 A1), further in view of Bennett et al (US 2014/0170211 A1), both in view of Kleidon et al (US 2017/0172977 A1) and Marengo et al (https://www.healthline.com/nutrition/fulvic-acid#benefits, 4/24/2020) and further in view both of De Rienzo et al (US 2019/0046486 A1) and of Kerchner et al (US 2020/0131255 A1).
Yedgar taught liposomal particles [0324] in suspension, for parenteral administration [0409], for the treatment of pathological conditions, including traumatic brain injury [0356].
Yedgar did not teach liposomal adenosine triphosphate salt, methylcobalamin, glutathione, liposomal curcumin, liposomal resveratrol, taurine, fulvic acid and acetyl L-carnitine, as recited in claim 1.
Roy taught an intravenous pharmaceutical composition for treating traumatic brain injury, comprising administering magnesium ATP [claims 1, 3 and 38].
Since Yedgar taught intravenous formulations for the treatment of traumatic brain injury, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Yedgar, magnesium ATP, as taught by Roy. The ordinarily skilled artisan would have been motivated to treat traumatic brain injury. Generally, it is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. The idea for combining them flows logically from their having been individually taught in the prior art. See MPEP 2144.06. In the instant case, it is prima facie obvious to combine the active agents of Yedgar with those of Roy, in order to form a composition, formulation or product, with active agents useful for the purpose of treating traumatic brain injury, as taught by each of Yedgar and Roy.
The combined Yedgar and Roy did not teach methylcobalamin.
Marshall taught methylcobalamin as an ingredient [claims 11 and 12] in compositions for treating traumatic brain injury [0128].
Marshall, though, did not teach an intravenous composition or formulation.
However, Tanaka taught intravenous administration of methylcobalamin [claim 1], as useful in methods of treating nervous system diseases [abstract and title].
It is prima facie obvious to combine the active agents of Yedgar and Roy, with those of Marshall, in order to form a composition, formulation or product, with active agents useful for the purpose of treating traumatic brain injury, as taught by each of Yedgar, Roy and Marshall.
Yedgar, Roy and Marshall did not teach glutathione.
McGavern taught methods of treating traumatic brain injury [claim 2] in a patient, comprising administering glutathione [abstract] in formulations by intravenous administration [0085].
It is prima facie obvious to combine the active agents of Yedgar, Roy and Marshall, with those of McGavern, in order to form a composition, formulation or product, with active agents useful for the purpose of treating traumatic brain injury, as taught by each of Yedgar, Roy, Marshall and McGavern.
Yedgar, Roy, Marshall and McGavern did not teach liposomal curcumin.
Sordillo taught methods and compositions comprising administering liposomal curcumin [0017-0020, 0056, 0070-0073]. Sordillo taught treating traumatic brain injury [claim 4], and the compositions were administered intravenously [claim 18].
It is prima facie obvious to combine the active agents of Yedgar, Roy, Marshall, and McGovern with those of Sordillo, in order to form a composition, formulation or product, with active agents useful for the purpose of treating traumatic brain injury, as taught by each of Yedgar, Roy, Marshall, McGavern and Sordillo.
Yedgar, Roy, Marshall, McGavern and Sordillo did not teach liposomal resveratrol.
But, Wdowin taught that when resveratrol is administered with curcumin, the effects of traumatic brain injury are mitigated [abstract].
It would be prima facie obvious to one of ordinary skill in the art to include Wdowin’s resveratrol with Sordillo’s composition comprising liposomal curcumin, because as was taught by Wdowin, when resveratrol is administered with curcumin, the effects of traumatic brain injury are mitigated [Wdowin at the abstract].
Yedgar, Roy, Marshall, McGavern, Sordillo and Wdowin did not teach taurine.
Bennett taught taurine as an ingredient useful in treating traumatic brain injuries [abstract].
It is prima facie obvious to combine the active agents of Yedgar, Roy, Marshall, McGovern, Sordillo and Wdowin, with those of Bennett, in order to form a composition, formulation or product, with active agents useful for the purpose of treating traumatic brain injury, as taught by each of Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin and Bennett.
Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin and Bennett did not teach fulvic acid.
Kleidon taught fulvic acid as an ingredient [claim 11, ¶ 0013] in a composition useful in treating traumatic brain injury [0097]. Said compositions were administered intravenously [0109, 0113].
Kleidon taught fulvic acid and traumatic brain injury among lists of ingredients and disorders.
However, Marengo specifically taught that shilajit (e.g., fulvic acid) improves outcomes (e.g., brain health) after traumatic brain injury, by reducing swelling and pressure in the brain [section entitled May protect brain function, 1st and 2nd paragraphs].
It is prima facie obvious to combine the active agents of Yedgar, Roy, Marshall, McGovern, Sordillo, Wdowin and Bennett, with those of Kleidon and Marengo, in order to form a composition, formulation or product, with active agents useful for the purpose of treating traumatic brain injury, as taught by each of Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin, Bennett, Kleidon and Marengo.
Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin, Bennett, Kleidon and Marengo did not teach acetyl-L-carnitine.
De Rienzo taught compositions comprising acetyl-L-carnitine [claims 1 and 3] for the treatment of traumatic brain injury [abstract].
De Rienzo was silent a parenteral formulation.
Nonetheless, Kerchner taught that acetyl-L-carnitine [0205] can be administered in parenteral formulations [0212].
It is prima facie obvious to combine the active agents of Yedgar, Roy, Marshall, McGovern, Sordillo, Wdowin, Bennett, Kleidon, Marengo and Rienzo, with those of Kerchner, in order to form a composition, formulation or product, with active agents useful for the purpose of treating traumatic brain injury, as taught by each of Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin, Bennett, Kleidon, Marengo and De Rienzo.
Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin, Bennett, Kleidon, Marengo and De Rienzo read on claim 1 and 4.
Claim 2 is rendered prima facie obvious because Yedgar taught ingredient encapsulation, at the abstract and at ¶s [0002, 0026, 0341]. Obtained liposomes were sized less than 100 nm [0041].
The instant claim 2 recites less than 120 nm; between 70-100 nm.
Yedgar taught less than 100 nm. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 4, the instant claim recites “wherein glutathione will be removed from the formula…until additional testing can determine whether glutathione contributes to these symptoms”. The limitation of removing glutathione from the formulation is a product-by-process limitation (see the below Examiner’s Note). Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Even though the 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 claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
In the instant case, Yadgar and McGavern’s liposomal suspension of ingredients comprising glutathione reads on the claimed colloidal suspension including glutathione as an ingredient. As such, the patentability of the instant product does not depend on its method of production, and the Applicant’s limitation regarding the process of removing the glutathione until the determination of additional testing is necessary is not patentable, in view of the combination of Yadgar and McGavern. MPEP 2113.
Claim(s) 3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yedgar et al (US 2014/0199241 A1), in view of Roy et al (USP 8,945,623 B2), both of Marshall et al (US 2021/0228663 A1) and Tanaka et al (US 2023/0302040 A1), further in view of McGavern et al (US 2015/0011626 A1), both in view of Sordillo et al (US 2020/0360300 A1) and Wdowin et al (US 2018/0200216 A1), further in view of Bennett et al (US 2014/0170211 A1), both in view of Kleidon et al (US 2017/0172977 A1) and Marengo et al (https://www.healthline.com/nutrition/fulvic-acid#benefits, 4/24/2020), both in view of De Rienzo et al (US 2019/0046486 A1) and Kerchner et al (US 2020/0131255 A1), and further in view of Walpole et al (BMC Public Health, 2012, 12:439, 1-6).
The 35 U.S.C. 103 rejection over Yedgar, in view of Roy, Marshall, Tanaka, McGavern, Sordillo, Wdowin, Bennett, Kleidon, Marengo, De Rienzo and Kerchner, was previously discussed.
Additionally, Yedgar taught dosages of 0.01 to 100 mg/kg body weight [0418], administered to humans [0341].
Roy taught magnesium ATP, as was previously discussed.
Sordillo taught liposomal curcumin, as was previously discussed.
Wdowin taught resveratrol, as was previously discussed.
Bennett taught taurine, as was previously discussed.
Kleidon and Marengo taught fulvic acid, as was previously discussed.
The combined Yedgar, Roy, Sordillo, Wdowin, Bennett, Kleidon and Marengo was not specific a dosage that exceeds 10 mg of adenosine triphosphate salt, as recited in claim 3; a dosage of liposomal curcumin of 10 mg to 1000 mg, as recited in claim 5; a dosage of liposomal resveratrol of 10 mg to 1500 mg, as recited in claim 6; a dosage of taurine at 10 mg to 1000 mg, as recited in claim 7; a dosage of fulvic acid at 10 mg to 2000 mg, as recited in claim 8.
Walpole taught that the world average body mass (adult) was 62.0 kg in 2005 [see Table 3].
It is prima facie obvious to one of ordinary skill in the art that the combined teachings of Yedgar and Roy teach ingredients at 0.62 mg (0.01 mg/kg x 62 kg = 0.62 mg) to 6200 mg (100 mg/kg x 62 kg = 6200 mg), which overlaps the recitation of the instant claims.
The instant claim 3 recites a dosage (liposomal ATP salt) that exceeds 10 mg.
The instant claim 5 recites a dosage (liposomal curcumin) that exceeds 10 mg to 1000 mg.
The instant claim 6 recites a dosage (liposomal resveratrol) that exceeds 10 mg to 1500 mg.
The instant claim 7 recites a dosage (taurine) that exceeds 10 mg to 1000 mg.
The instant claim 8 recites a dosage (fulvic acid) that exceeds 10 mg to 2000 mg.
Yedgar taught dosages of 0.62 mg to 6200 mg. A prima facie case of obviousness exists because of overlap, as discussed above.
Examiner’s Note
The Examiner notes that claims 1-8 recite product-by-process limitations. The product-by-process limitations are as follows:
Claim 1: “that will be delivered intravenously or by other parenteral means to treat traumatic brain injury”
Claim 2: “to reduce immune system clearance and to improve delivery to damaged brain parenchyma”
Claim 3: “where the precise dosage will provide efficacy against secondary pathology caused by traumatic brain injury, yet the precise dosage will not exceed an amount that would cause a statistically significant increase of ATP in the brain’s extracellular space after a traumatic brain injury”
Claim 4: “wherein glutathione will be removed from the formula for patients with a history of Stevens-Johnson syndrome or toxic epidermal necrolysis, until additional testing can determine whether glutathione contributes to symptoms of these conditions”
Claim 5: “where the precise dosage will not exceed an amount that would produce a statistically significant and adverse decrease in platelet aggregation after a traumatic brain injury”
Claim 6: “where the precise dosage will not exceed an amount that would produce a statistically significant and adverse decrease in platelet aggregation after a traumatic brain injury”
Claim 7: “where the precise dosage will not exceed an amount that would cause a statistically significant increase of neuronal influx of chloride ions after a traumatic brain injury”
Claim 8: “where the precise dosage will not exceed an amount that would cause a statistically significant increase in cerebral free iron levels after a traumatic brain injury”
These are product-by-process limitations. Product by process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.
Even though the 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 claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
In the instant case, the liposomal suspension of the combined teachings of Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin, Bennett, Kleidon, Marengo and De Rienzo reads on the claimed colloidal suspension.
As such, the patentability of the instant colloidal suspension of ingredients does not depend on its methods, and the Applicant’s limitations regarding the: delivery to treat traumatic brain injury (claim 1); reducing immune clearance, improving delivery to damaged brain (claim 2); efficacy of dosages (claim 3); removal of glutathione (claim 4); and, dosage amounts that would or would not produce statistically significant and adverse events (claims 5-8); is not patentable, in view of the combined teachings of Yedgar, Roy, Marshall, McGavern, Sordillo, Wdowin, Bennett, Kleidon, Marengo and De Rienzo. MPEP 2113.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612