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
The office acknowledges Applicants filing of the claims and arguments in response to the restriction election requirement dated 11/12/2025. Applicants have elected Group I, claims 53-56 without traverse (see response dated 5/12/2026). Claims 57-72 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142(b), as being drawn to non-elected subject matter. Applicants filed claim amendments on 7/2/2026 adding new claims 73-119. Claims 53-119 are pending. The claims corresponding to the elected subject matter are 53-56, 73-119 and are herein acted on the merits.
Application Priority
This application filed 07/12/2023 is a Continuation of 17170734, filed 02/08/2021, now U.S. 11730747, 17170734 is a Continuation of 14775621, filed 09/11/2015, 14775621 is a National Stage entry of PCT/US14/23251, International Filing Date: 03/11/2014, 14775621 is a Continuation of 13972274, filed 08/21/2013,13972274 is a Continuation in Part of 13803716, filed 03/14/2013.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/12/2023 and 6/20/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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.
Claim(s) 53-55 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shamsuddin et al. (IDS: US 20070293458) as evidenced by Alternative Medicine Review (IDS: 2002, 244-248).
Shamsuddin et al. disclose composition comprising IP6, inositol and water (example 6). The reference teach a method for preventing or treating acute short-term adverse health effects of ionizing radiation exposure in a mammal, comprising: administering to the mammal an effective amount of a pharmaceutical composition comprising IP-6, its pharmaceutically acceptable salts and inositol; the composition is liquid (See claims 1-4).
Alternative Medicine Review reference teach inositol hexaphosphate (IP6) is also known as myo-inositol hexaphosphate (See p 244, para 1).
As evidenced by Alternative Medicine Review, IP6 is myo-inositol hexaphosphate Claims 53-55 is anticipated by Shamsuddin’s teaching an aqueous liquid pharmaceutical composition that comprises water, IP6 (hexamonophosphate, phosphorylated inositol) and inositol (unphosphorylated inositol). It is noted that the other components in claim 55 are optional.
Claim(s) 53-54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loss (J Vis Exp. 2011 Sep 3;(55):3027).
Loss teach that myo-inositol is present in nature either unmodified or in more complex phosphorylated derivates. Further taught is that IP5 and IP6 are the precursors of inositol pyrophosphate molecules that contain one or more pyrophosphate bonds. The reference is to the preparation of quality inositol pyrophosphates. The reference teaches IP5 and IP6 inositol pyrophosphates that were subsequently eluted in water (See Abstract).
Loss anticipates the claimed aqueous liquid formulation comprising water and IP5 and IP6 inositol pyrophosphates (pentamonophosphate and hexamonophosphate) thus addressing claims 53-54. It is noted that the other components in claim 55 are optional.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 53, 55-56 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.
Claim 53 recites a limitation of ‘an unphosphorylated member of myoinositol and/or an optical isomer thereof’. It is not clear how, myoinositol (a meso compound) having a plane of symmetry has optical isomers? Clarification is required. It is noted that inositol has nine stereoisomers and only chiro inositol has optical isomers, D and L.
Claims 55-56, recite a limitation of ‘wherein when said unphosphorylated inositol’ and ‘when the unphosphorylated inositol’ in lines 1-2. However there is no inositol component in general in claim 53 but unphosphorylated myoinositol as an optional component. It is noted that myoinositol is an inositol isomer. There is no antecedent basis for the claim limitations. For the sake of examination, claims 55-56 are examined based on the interpretation that the optional unphosphorylated member component is inositol.
Claim 76 is 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.
Claim 76 recites a limitation of ‘further comprising an unphosphorylated member’. This limitation is indefinite because it is unclear what compounds or components or agents encompass ‘unphosphorylated member’. It can be a compound, enzyme, protein, peptide etc. Thus, the metes and bounds of patent protection sought for the instantly claimed formulations have not been defined.
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.
Claim(s) 53-56, 116-118 are rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin et al. (IDS: US 20070293458) and Kong et al. (J of Food composition and Analysis, 21, 2008, 501-504).
Shamsuddin et al. disclose composition comprising IP6, inositol and water (example 6). The reference teach a method for preventing or treating acute short-term adverse health effects of ionizing radiation exposure in a mammal, comprising: administering to the mammal an effective amount of a pharmaceutical composition comprising IP-6, its pharmaceutically acceptable salts and inositol; the composition is liquid (See claims 1-4). Shamsuddin further teach that IP-7 is a derivative of IP-6 [0047]. Shamsuddin teach electrolytes in the composition [0165].
Kong has been cited to teach that inositol, also known as hexahydroxy cyclohexane, has nine different forms (isomers), the most well-known is myo-inositol and other form include D-chiro inositol (See Introduction, p 501, para 2, col. 1, col. 2, lines 4-5).
From Shamsuddin a person skilled in the art before the effective filing date of the invention would have found it obvious to arrive at the claimed aqueous liquid formulation comprising the phosphorylated myoinositol (hexamonophosphate), and inositol. A skilled artisan would have been motivated to arrive at claims 53-54 with a reasonable expectation of success and use it for treating adverse health effects associated with ionizing radiation.
As to claims 55-56, the claims have been examined based on the interpretation that the composition comprises unphosphorylated isomer of the phosphorylated member claimed in claim 54 and an unphosphorylated isomer of other phosphorylated members not in the composition. The teachings of Shamsuddin and Kong addresses claims 55-56 by teaching inositol in the composition. Inositol has several isomers that include myoinositol (unphosphorylated inositol of the myo-inositol phosphorylated member and or D-chiro-inositol (unphosphorylated inositol different than that of the myo-inositol phosphorylated member). In other words a person skilled in the art would have found it obvious that Shamsuddin’s composition that comprises inositol includes stereoisomers of unphosphorylated myo-inositol and D-chiro-inositol. It is suggested that the claims be written as for e.g. ‘the formulation of claim 53, wherein the unphosphorylated inositol or optical isomer is selected from one of the inositol phosphorylated members’; ‘the formulation of claim 54, wherein the unphosphorylated inositol or optical isomer is selected from one of the inositol phosphorylated members that is not present in claim 54. As to claim 116, same myoinositol pyrophosphate is being taught by the reference, thus meeting the claim limitation(s). As to claim 117, the reference Shamsuddin teach addition of electrolytes in the composition. As to claim 118, the reference teaches that IP-7 is a derivative of IP-6 inositol. Hence a skilled artisan would have found it obvious to add the derivative of IP-6, which is IP-7 in the composition as it will have similar properties and effects/benefits.
Claims 119 are rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin et al. (IDS: US 20070293458) and Kong et al. (J of Food composition and Analysis, 21, 2008, 501-504) in view of Miller et al. (CN 1372452 A).
Shamsuddin and Kong as above. The above rejection is incorporated herein.
The prior art do not teach gallic acid in the composition.
Miller teach composition comprising gallic acid and magnesium for protection against harmful ultraviolet radiation (See title, abstract, claims 1, 6-7 and 30).
From Miller a skilled artisan would have found it obvious to add gallic acid, to the composition of Shamsuddin. A person of ordinary skill in the art would have been motivated to arrive at the claimed composition with a reasonable expectation of success and for protection against ionizing or harmful ultraviolet radiation.
Claim(s) 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (US 20110105433 A1).
Braun teach a composition comprising anti-oxidants, e.g. phytic acid, resveratrol, flavonoids, (0.001-1 wt%), lecithin and LC-PUFA. The product can be beverage, nutritional complete formula, liquid drink etc. (claims 1, 7, 10). The nutritional composition comprises Vitamins and minerals [0042].
From the teachings of Braun a person of ordinary skill in the art would have found it obvious to arrive at the claimed formulation comprising at least one phosphorylated inositol (phytic acid is myo-inositol-1,2,3,4,5,6-hexakisphosphate; InsP6) and water. A person of ordinary skill in the art would have been motivated to arrive at the claimed composition with a reasonable expectation of success and to use it as a nutritional drink. Thus claims 53-54 would have been obvious over Braun.
Claims 55-56, 73, 76-89, 98-103, 105-106, 108-109, 116, 117 are rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (US 20110105433 A1) as applied to claims 53-54 above, in view of Smith et al. (US 20080213401 A1) and Robertson (US 20060280840 A1).
Braun teachings discussed as above. The rejection is incorporated herein.
Braun is not explicit in teaching the limitations in regards to the additional agents as claimed.
Smith teachings relate to nutrition or dietary supplement composition for the support of healthy memory and optimizing mental energy, comprising inositol (50-500 mg), at least one alpha amino acid, N-acetyl-L-cysteine (100-500 mg), plant extract(s), e.g. green tea extract, grape seed extract, water soluble vitamins, Vitamin B12 (10-40 mcg), Vitamin C (magnesium ascorbate, potassium ascorbate, ascorbyl palmitate- 40-400 mg) and grape seed extract (25-100 mg) (See Abstract, claims 1-3, 7, 10, 11, 20 of Smith, [0009][0050][0052]). As used herein inositol refers to one or more forms of inositol including myo-inositol ([0045], last two lines). Further taught is isoflavone (soy or red clover, 40-100 mg) consumption significantly improves memory in adults [0054]. Green tea extract concentrates have active polyphenol constituents (catechins) ([0029], line 1) and green tea extract in the composition may be in the amount of 50-200 mg, e.g. EGCG (Epigallocatechin Gallate) (page 3, [0029], first two lines and [0030] last two lines). Liquid dosage forms for oral administration include solutions, suspensions, elixir, syrups include solvents such as water ([0061], lines 1-5),
Robertson teaches rich nutritional liquid formulation that comprises nutrients, vitamins, minerals and flavorings to enhance taste and further control the need for caloric intake (Abstract, claim 1). The composition includes soy protein, flavoring agents, coloring agent, sodium chloride, Vitamin A, ascorbic acid, Vitamin B1, lecithin, riboflavin, sweetener etc. (See claims 1, 7, 14, 26, 47). Lecithin protects cells from oxidation and largely comprises the protective sheaths surrounding the brain. It is composed mostly of B vitamins, phosphoric acid, choline, linoleic acid and inositol [263].
From Smith a skilled artisan would have found that nutritional drink comprises additional ingredients such as inositol,
From the combined prior art one of ordinary skill in the art would have found it obvious to formulate an aqueous liquid composition comprising water, phosphorylated myo-inositol, N-acetyl cysteine, Vitamin C (which is ascorbic acid), genistein (soy isoflavone, genistein is a naturally occurring compound that structurally belongs to a class of compounds known as isoflavones), resveratrol, unphosphorylated inositol, e.g. myoinositol, sodium chloride, thiamine (Vitamin B1), epigallocatechin gallate, coloring agent, flavoring agent as nutritional composition for oral delivery. One of ordinary skill in the art would have been motivated to formulate such a composition with reasonable expectation of success and to use it as a nutrition or dietary supplement composition for the support of healthy memory and optimizing mental energy. Claims 55 is addressed as the resulting composition will have both the phosphorylated and unphosphorylated myo-inositol. As to claim 56, Smith teach any type of inositol form and hence one of ordinary skill in the art would have found it obvious to add other inositol isomers, for e.g. chiro-inositol. Thus claims 55-56, 73, 76-77, 80-83, 85-87, 98, 99, 100, 102-103, 105-106, 117 are addressed. As to claims 78-79, 84, 88, 89, 101, 108-109 in regards to the amount of the components in the composition, it is noted that it is routinely adjustable and is within the skill of an artisan. Smith teach 50-500 mg of inositol isomers, myo-inositol and Braun teach anti-oxidants, e.g. phytic acid, (0.001-1 wt%) which can be in an amount of 1 ug –1 g. If 600 mg of phytic acid and 60 mg of myo-inositol is added the ratio is 6:1 and if 50 mg of phytic acid and 50 mg of myo-inositol is added the ratio is 1:1. Smith teach of 40-400 mg ascorbic acid, (if 40 mg added it is 0.04% in 100 ml liquid); soy isoflavones in an amount of 40 mg; and Vitamin B12 10-40 mcg. It is well known that a person of ordinary skill could optimize those parameters through nothing more than routine experimentation. In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious. As to claim 116, same myoinositol pyrophosphate is being taught by the reference, thus meeting the claim limitation(s).
Claims 74-75, 107 are rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (US 20110105433 A1) in view of Smith et al. (US 20080213401 A1) and Robertson (US 20060280840 A1) as applied to claims above and further in view of Harris et al. (WO 2006080903 A2).
Braun, Smith and Robertson as discussed as above. The rejection(s) above are incorporated herein.
The references do not teach that the composition further comprises ubiquinol.
Harris teach coenzyme Q10 for nutritional use. The reference teaches orally administrable liquid nutrition supplement comprising CoQ10 (ubiquinol) (See claims 58, 21, p 2, line 1).
A person of ordinary skill in the art before the effective filing date of the invention would have found it obvious to add reduced CoQ10 (which is ubiquinol) to the composition formulated from the combined prior art teachings. A person of ordinary skill in the art would have been motivated to add ubiquinol to the liquid formulation with a reasonable amount of success and to provide additional nutrient to the liquid composition. As to the limitation of orally absorbable form, it is noted that the composition comprising ubiquinol if administered as oral aqueous liquid form formulated from prior art, then it meets the limitation. Thus claims 74-75, 107 would have been obvious over the combined prior art teachings.
Claim 104 is rejected under 35 U.S.C. 103 as being unpatentable over Braun et al. (US 20110105433 A1) as applied to claims above, in view of Smith et al. (US 20080213401 A1) and Robertson (US 20060280840 A1) and further in view of Bernardi (IT MI2012109, English translation).
Braun, Smith and Robertson as discussed as above. The rejection(s) above are incorporated herein.
The references do not teach that the composition further comprises 3-hydroxytyrosol.
Bernardi teach antioxidant and anti-radical formulation for human food comprising vegetable oil, vitamin E and 3-hydroxytyrosol (See abstract, claim 1).
A person of ordinary skill in the art before the effective filing date of the invention from Bernardi would have found it obvious to add 3-hydroxytyrosol to the composition derived from the prior art teachings. A person of ordinary skill in the art would have been motivated to arrive at the claimed composition with a reasonable expectation of success and for the composition with anti-oxidant effects. Thus claim 104 is addressed.
Claims 90, 91, 93, 95, 96 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolau et al. (WO2011005886A1).
Nicolau et al. teach inositol trisphosphate (ITPP) causes normalization of tumor vasculature and is a particularly effective cancer therapy (abstract). The reference teaches ITPP, in particular hexasodium myo-inositol trispyrophosphate for treatment of cancer (Fig. 7). Further taught is the composition comprising inositol trispyrophosphate; preferred isomer for the ITPP employed is myoinositol, which is cis-l,2,3,5-trans-4,6-cyclohexanehexyl; however, the invention is not so limited; the invention contemplates the use of any inositol isomer in the ITPP, including the respective tripyrophosphates of the naturally occurring scyllo-, chiro-, muco-, and neo-inositol isomers, as well as those of the allo, epi-, and cis-inositol isomers (See p 8, p 9, lines 17-22). Formulations suitable for administration include oral aqueous liquid (p 12, line 28), flavoring agents in the composition (p 12, line 23). The pharmaceutical composition comprising ITTP and an addition agent, e.g. genistein is claimed (See claims 15-16).
From Nicolau a skilled artisan before the effective filing date of the invention would have found it obvious to formulate a composition comprising water and hexasodium myo-inositol trispyrophosphate and genistein. A skilled artisan from the teachings of Nicolau would have been motivated to arrive at the claimed composition with a reasonable expectation of success and to use the composition for treating cancer. Thus claims 90, 91, 93, 96 are addressed. As to the ratio amount in claim 95, it is well known that a person of ordinary skill could optimize those parameters through nothing more than routine experimentation. In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious.
Claims 92, 97 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolau et al. (WO2011005886A1) in view of Mazzio (US 20060035981 A1).
Nicolau as discussed as above. The rejection above is incorporated herein.
The reference do not teach that the composition further comprises luteolin or ubiquinol.
Mazzio teach composition comprising ubiquinols for treating cancer (See abstract, claims 5, 16). Mazzio teach the extract of rosemary can increase the sensitivity and prevent the efflux of chemotherapeutic agents [0017] and luteolin is a constituent of rosemary [0038].
A skilled artisan before the effective filing date of the invention would have found it obvious to add ubiquinol to the composition of Nicolau from Mazzio’s teachings. A skilled artisan would have been motivated to add ubiquinol to Nicolau’s ITTP composition with a reasonable expectation of success and to use the composition for treating cancer. As to the limitation of orally absorbable form, it is noted that the composition comprising ubiquinol if administered as oral aqueous liquid form formulated from prior art, then it meets the limitation. Thus claim 97 is addressed. As to claim 92, the reference teaches the effects of rosemary and rosemary contains luteolin. Hence a skilled artisan would have been motivated to add luteolin to Nicolau’s ITTP composition to enhance the anti-cancer effects.
Claim 92 is rejected under 35 U.S.C. 103 as being unpatentable over Nicolau et al. (WO 2011005886 A1) in view of Powell (US 8075902 B2).
Nicolau as discussed as above. The rejection above is incorporated herein.
The reference do not teach that the composition further comprises luteolin.
Powell claims a method of treatment of cancer administering luteolin, curcumin, niacinamide and ascorbic acid (claim 1).
As to claim 92, from Powell a skilled artisan would have found it obvious to add luteolin to the composition of Nicolau. A skilled artisan would have been motivated to add luteolin to Nicolau’s ITTP composition to enhance the anti-cancer effects.
Claim 94 is rejected under 35 U.S.C. 103 as being unpatentable over Nicolau et al. (WO 2011005886A1) in view of Hecht et al. (Cancer Letters, 167, 2001, 1-6).
Nicolau as discussed as above. The rejection above is incorporated herein.
The reference do not teach that the composition further comprises an unphosphorylated member, myo-inositol.
Hecht teach that myo-inositol as an inhibitor of lung tumorigenesis and significantly lung tumor multiplicity in mice model (abstract).
From Hecht a skilled artisan would have found it obvious to add myo-inositol to the composition of Nicolau. A skilled artisan would have been motivated to add myo-inositol to Nicolau’s ITTP composition to enhance the anti-cancer effects.
Claims 110-115 are rejected under 35 U.S.C. 103 as being unpatentable over Shamsuddin et al. (IDS: US 20070293458) and Kong et al. (J of Food composition and Analysis, 21, 2008, 501-504) in view of Hahn (CA 2867439 A1) and Miller et al. (CN 1372452 A) and further in view of Montesinos (US 20130224281 A1).
Shamsuddin et al. disclose composition comprising IP6, inositol and water (example 6). The reference teach a method for preventing or treating acute short-term adverse health effects of ionizing radiation exposure in a mammal, comprising: administering to the mammal an effective amount of a pharmaceutical composition comprising IP-6, its pharmaceutically acceptable salts and inositol; the composition is liquid (See claims 1-4). Additional agents include vitamins [0146]; antioxidants include ubiquinone and ubiquinol and their derivatives, vitamin C and derivatives (e.g. ascorbyl palmitate, Mg-ascorbyl phosphate, ascorbyl acetate), tocopherols and derivatives (e.g. vitamin E acetate) [0168] and electrolytes [0165].
Kong has been cited to teach that inositol, also known as hexahydroxy cyclohexane, has nine different forms (isomers), the most well-known is myo-inositol and other form include D-chiro inositol (See Introduction, p 501, para 2, col. 1, col. 2, lines 4-5).
The above prior art is not explicit in teaching gallic acid or magnesium.
Hahn teaches compositions comprising divalent cationic strontium, polyhydroxyphenols and a cysteine-based antioxidant [0008]. The polyhydroxyphenols include luteolin, epigallocatechin gallate, epigallocatechin, epicatechin gallate, genistein and myricetin, or mixtures thereof and the cysteine-based anti-oxidant may be selected from the group consisting of: cysteine, cystine, N-acetyl cysteine (NAC) [0009], [0010]. The polyhydroxyphenol(s) is(are) in essentially pure form when added to the compositions described herein, or is(are) added in the form of a plant extract, such as green tea or soy extract. [0013]. (also see claims 1, 3, 5, 14, 18). The compositions are useful for treating skin conditions arising from ionizing radiation [00147].
Miller teach composition comprising gallic acid and magnesium for protection against harmful ultraviolet radiation (See title, abstract, claims 1, 6-7 and 30).
From Hahn and Miller a skilled artisan would have found it obvious to add gallic acid, magnesium and N-acetyl-L-cysteine to the composition of Shamsuddin. A person of ordinary skill in the art would have been motivated to arrive at the claimed composition with a reasonable expectation of success and for protection against ionizing or harmful ultraviolet radiation.
The above art is not explicit in teaching the vitamins in the composition as Vitamin D and Vitamin B12.
Montesinos teach a radiation-oxidative exposure treatment composition for ameliorating radiation-induced life shortening effects from exposure to a radiation source that comprises Vitamin D, vitamin C and Vitamin B12 (See claims 1, 3).
From Montesinos a skilled artisan would have found it obvious to add Vitamin D and Vitamin B12 as the Vitamins in Shamsuddin’s composition. A person of ordinary skill in the art would have been motivated to arrive at the claimed composition with a reasonable expectation of success and for protection against harmful radiation effects.
From the combined teachings of the prior art a person skilled in the art would have found it obvious to arrive at the composition of claims 110-113, with a reasonable expectation of success. person of ordinary skill in the art would have been motivated to arrive at the claimed composition to use it for protection against harmful radiation effects. As to claim 114, Shamsuddin teaches additional agent include electrolytes. Hence a skilled artisan would have found it obvious to add sodium chloride electrolyte in the composition for fluid balance. As to claim 115, Shamsuddin teach inositol in the composition. It is within the skill of an ordinary artisan to add an inositol isomer in the composition with a reasonable expectation of success.
Note: The prior art of record not relied upon: WO 9200744 teach an aqueous liquid composition of myoinositol phosphate by teaching sodium salt of myo-inositol-1,2,3-trisphosphate was dissolved in 900 ml of an aqueous solution of sodium acetate buffer pH 4.6.
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 53-56, 73-89, 98-103, 105-119 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11730747 (‘747) and Kong et al. (J of Food composition and Analysis, 21, 2008, 501-504) and further in view of Smith et al. (US 20080213401 A1) and Robertson (US 20060280840 A1).
The instant examined claim 53-56, 73-89, 116-118 are directed to an aqueous liquid formulation comprising water, at least one phosphorylated member selected from phosphorylated myoinositol; the dependent claims are limited to specific phosphorylated members, additional unphosphorylated member of myoinositol or an optical isomer thereof. The dependent claims are limited to specific myo-inositol phosphate forms, its isomers. Claims 90-115 are directed to:
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‘747 reference claims are drawn to an aqueous liquid formulation, comprising: (a) water; (b) at least one phosphorylated inositol isomer selected from myoinositol hexaphosphate or an orally-acceptable salt thereof, at a concentration of about 0.5 to about 4% (w/v); (c) N-Acetyl-L-cysteine; (d) about 0.025 to about 0.05% (w/v) L-Ascorbic acid or L-Ascorbate; (e) Genistein; and (f) a liposomal-encapsulated Ubiquinol, wherein the ratio of the liposomal-encapsulated ubiquinol to the myoinositol hexaphosphate or the orally-acceptable salt thereof is 1:2.5 to 1:25 (w/v). The dependent claims are limited to other agents e.g. luteolin, rutin, resveratrol, catechin, molar ratio of myoinositol hexaphosphate to unphosphorylated myoinositol is about 6:1 to 1:6, amounts. The formulation further comprising at least one unphosphorylated inositol or optical isomer thereof, present in the form as the inositol isomer in the phosphorylated inositol isomer.
The instant claims would have been obvious over the reference claims based on the teachings of aqueous liquid formulation comprising myoinositol hexaphosphate.
The reference claims are not explicit in teaching some of the additional agents as claimed.
Smith and Robertson teachings discussed as above.
From the references a skilled artisan would have found it obvious to add agents like resveratrol, ascorbic acid (Vitamin C), epigallocatechin gallate, other catechins, sweetener, flavoring agent or other excipients, electrolytes (e.g. sodium chloride) other Vitamins etc. and arrive at the claimed composition(s). As to claims 54-55, the reference claims teaches unphosphorylated inositol in the composition. Hence this can be any inositol, e.g. myoinositol, chiro-inositol etc. As to claims 78-79, 84, 88, 89, 101, 108-109 in regards to the amount of the components in the composition, it is noted that it is routinely adjustable and is within the skill of an artisan. Smith teach 50-500 mg of inositol isomers, myo-inositol and Braun teach anti-oxidants, e.g. phytic acid, (0.001-1 wt%) which can be in an amount of 1 ug –1 g. If 600 mg of phytic acid and 60 mg of myo-inositol is added the ratio is 6:1 and if 50 mg of phytic acid and 50 mg of myo-inositol is added the ratio is 1:1. Smith teach of 40-400 mg ascorbic acid, (if 40 mg added it is 0.04% in 100 ml liquid); soy isoflavones in an amount of 40 mg; and Vitamin B12 10-40 mcg. It is well known that a person of ordinary skill could optimize those parameters through nothing more than routine experimentation. In re Aller, 220 F. 2d454, 456, 105 USPQ 233,235 (CCPA 1955) the courts maintained that: "Where the general condition of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." As formulating optimal compositions for medicaments is routine in the art of pharmacology, the claims are considered to be prima facie obvious. As to claim 116, same myoinositol pyrophosphate is being taught by the reference, thus meeting the claim limitation(s).
Claims 90-97 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11730747 (‘747) in view of Nicolau et al. (WO 2011005886A1).
The instant claims as above.
The reference claims as above.
The reference claims do not explicitly teach the composition comprises at least one inositol trisphosphate.
Nicolau as discussed above.
From Nicolau a skilled artisan before the effective filing date of the invention would have found it obvious to formulate a composition comprising water and hexasodium myo-inositol trispyrophosphate and genistein with a reasonable expectation of success and to use the composition for treating cancer. From the combined teachings of the reference claims and Nicolau a person skilled in the art would have arrive at the claimed formulations of claims 90-97.
Claim 104 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 11730747 (‘747) and Kong et al. (J of Food composition and Analysis, 21, 2008, 501-504) and further in view of Smith et al. (US 20080213401 A1) and Robertson (US 20060280840 A1) and further in view of Bernardi (IT MI2012109, English translation).
The instantly claimed composition of claim 104 further comprises 3-hydroxytyrosol.
The reference claims, King, Smith and Robertson as above.
The above references do not teach 3-hydroxytyrosol in the composition.
Bernardi teachings as above.
A person of ordinary skill in the art from Bernardi would have found it obvious to add 3-hydroxytyrosol to the composition derived from the reference claims and prior art teachings that comprises myoinositol hexaphosphate with a reasonable expectation of success and for the composition with anti-oxidant effects. Thus claim 104 is addressed.
Conclusion
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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