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 .
Priority
This application is a National-Stage entry of PCT/IB2023/051203, filed 2/10/2023. Applicant’s claim for the benefit of a prior-filed application IN202241008177 filed 2/16/2022, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group 17), in the reply filed on 6/9/2026 is acknowledged.
Response to Amendment
Applicant’s amendment to the claims filed 6/9/2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims. It is noted that claims 2-11 and 18-21 have been amended to depend upon claim 17. Claims 23-24 are new.
Claims 2-11, 17-21, 23, and 24 are pending and have been examined on the merits.
EXAMINER’s COMMENT
Claim 17 is independent, and all other claims presented, 2-11, 18-21, 23, and 24 are dependent upon claim 17. Because none of the claims are multiple dependent claims, there is no ambiguity about which claims they refer. However, upon issue of any allowable claims in this application, the claims will have to be renumbered in accordance with 35 U.S.C. 112 and 37 CFR 1.75(c). MPEP § 608.01(n), Subsection F states that:
“ Pursuant to 35 U.S.C. 112 and 37 CFR 1.75(c), a claim in dependent form must refer only to a claim or claims previously set forth. The following procedures are to be followed by examiners when faced with claims which refer to numerically succeeding claims:
If any series of dependent claims contains a claim with an improper reference to a numerically following claim which cannot be understood, the claim referring to a following claim should normally be objected to and not treated on the merits.
However, in situations where a claim refers to a numerically following claim and the dependency is clear, both as presented and as it will be renumbered at issue, all claims should be examined on the merits and no objection as to form need be made. In such cases, an examiner’s amendment should be prepared if the order of the claims is changed.”
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/25/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statements (IDS) submitted on 8/19/2024 and 8/9/2024 are acknowledged. The information disclosure statements and references contained therein have been considered by the examiner, except where noted below.
The information disclosure statement filed 8/9/2024 fails to fully comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. No copy of the NPL reference titled “TKDL; AT/825, Bhagandaresclva aupancham, Knowledge known since 1000 years, The Whole Document” was provided on 8/9/2024. Further, no publication date was given for this reference.
In the IDS filed 8/19/2024, a copy of the reference “TKDL; AT/825, Bhagandaresclva aupancham, Knowledge known since 1000 years, The Whole Document” was provided, however again, no publication date was given for the reference. 37 CFR 1.98(b) requires that each item of information in an IDS be identified properly. MPEP § 609.04(a).I. states: “Where the actual publication date of a non-patent document is not known, the applicant must, at a minimum, provide a date of retrieval (e.g., the date a webpage was retrieved) or a time frame (e.g., a year, a month and year, a certain period of time ) when the document was available as a publication.
It has been placed in the application file, but the information referred to therein has not been considered.
Specification
The disclosure is objected to because of the following informalities:
The terms “Musculoskeletal”, “Turmeric”, “Hydrophilic”, Curcuminoids, “Acetyl-11-keto-beta-boswellic acid”, all of the common terms used in [0032], “Cramp”, “Dysmenorrhea” ([0044]), “Placebo” ([0045]), should not be capitalized.
TRADE NAMES, TRADEMARKS, AND OTHER MARKS USED IN COMMERCE:
The use of the terms MOTRIN, ADVIL, ALEVE, and NAPROSYN (in [0002]) which are each a trade name or a mark used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks (see MPEP 608.01(v) and 608.01(u)).
Appropriate correction is required. Applicant’s assistance in correcting any other formalities or typographical errors of which they may become aware of is requested.
Claim Objections
Claims 2-6, 11, 17-19, 23, and 24 are objected to because of the following informalities:
In claims 2 and 3, the phrases such as “the Turmeric extract – 10 to 50 wt%” are not properly presented and should instead say “the Turmeric extract in an amount of 10 to 50 wt %” for improved clarity. This applies to each of the ingredients presented in both claims 2 and 3.
In claim 11, line 2, the phrase “wherein the oil is selected from group consisting of...” is improper. The phrase should recite “wherein the oil is selected from a group consisting of”.
In claim 19, line 2, the phrase “wherein the edible oil is selected from group consisting of...” is improper. The phrase should recite “wherein the edible oil is selected from a group consisting of”.
Additionally, the word “Turmeric”, used throughout the specification and claims 17, 2-6, 11, 17-19, 23, and 24 should not be capitalized because this is a common name and not a proper noun or scientific name for the plant nor extract thereof.
Similarly, in claim 17 the word “Hydrophilic” should not be capitalized. In claims 5, and 7-8 the term “Acetyl-11-keto-beta-boswellic acid” should not be capitalized.
Appropriate correction is required.
Claim Interpretation
The claims used various terms which are well known in the art. It is noted that Boswellia is also known commonly as frankincense. The element of a Turmeric extract is also known as extract of Curcuma longa, of which the main active ingredient is curcumin and curcuminoids. The use of microemulsions of liquid substances including oils is convention in the art.
Claim Rejections - 35 USC § 112(b)
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 2-11, 17-21, 23, and 24 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 17 recites the limitation "the plant-based formulation comprising" in line 2. There is insufficient antecedent basis for this limitation in the claim. Because there is no preceding reference to any plant-based formulation” before independent claim 17, there is no way to determine what “the plant-based formulation” is in reference to.
Applicant is advised to amend the claim to recite “a plant-based formulation” or phrasing similar thereto in line 2.
In claim 18, the beginning word “A” has been deleted, and no replacement is provided. Thus, the claim is improper because it is not a full sentence beginning with a capitalized word. It is suggested to add “The” to the beginning of claim 18.
Further claim 18 recites the phrase “mixed well to get a high viscose blend” in lines 4-5. This claim element renders the metes and bounds of the claimed subject matter ambiguous. The term “mixed well” is a relative term which renders the claim indefinite. The term “mixed well” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One would not be able to determine what is mixed well and what is not, according to the claim language presented, because this is a subjective term. Similarly, there is no clear definition for what constitutes a “high viscose blend”. What is the level of viscosity necessary to fulfill this claim limitation? The claim is indefinite for each of these reasons.
Because these relative limitations pertain to functional qualities of a composition, any composition deemed to have essentially the same structural components will be deemed to fulfill this ambiguous claim language, as compositions having identical structures predictably have identical properties. Regardless, for claim 18, a product or composition is defined by the structure and not necessarily by the method in which it was mixed. For claim 18, the administration of an identical composition, even if produced in a different manner, is not patentably distinct from the use of one made in the recited manner.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
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.
Claims 2-11, 17-21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over “Benny” (US PGPub No. 20200384060, later issued as US Pat No. 11,241,472, on IDS filed 3/25/2025) in view of Sripathy et al. (US PGPub No. 20150072012, herein “Sripathy”) and Tabari et al. (“An investigation of the effect of curcumin (turmeric) capsule on the severity and duration of dysmenorrhea in students of Iran university of medical sciences.” J Evolution Med Dent Sci 2020;9(46):3444 3451).
Claim 17 recites “a method of reducing menstrual cramp pain in a mammal with primary dysmenorrhea by administering the plant-based formulation comprising a mixture of solid Turmeric extract and solid Boswellia extract, wherein the mixture is loaded into an oil with a Hydrophilic-lipophilic balance value ranging from 10 to 19 wherein Turmeric extract and Boswellia extract are in about 1:1 to 1:99 ratio by weight, and mixture has a particle size of 200 micrometre to about 100 nanometres.”
Benny (US PGPub No. 20200384060) pertains to analgesic and anti-inflammatory composition having a) an extract of Boswellia, b) one or more of an extract of Curcuma longa (i.e. a turmeric extract), a curcuminoid composition and combinations thereof, and, c) a sesame seed oil (Abstract, [0014], [0054]). Benny teaches that “The powdered curcuminoid mixture was also referred to as regular turmeric extract” ([0203]). Benny teaches in one example, a randomized active controlled study to assess the efficacy of sesame oil loaded with Boswellia extract and curcuminoid composition in adult patients with acute musculoskeletal pain ([0203]-[0230]).
Benny teaches that “The proportion of each component in the composition; Boswellia extract and extract of Curcuma longa or curcuminoid composition are in 1:1 to 5:1 ratio, preferably 3:1 by weight. The Boswellia extract and extract of Curcuma longa or curcuminoid composition to sesame oil are in 1:1 to 1:99 ratio, more preferably 1:1 to 1:10 by weight” ([0055]). Benny also teaches that “The composition includes a) an extract of Boswellia, b) one or more of an extract of Curcuma longa, a curcuminoid composition and combinations thereof, and, c) a sesame seed oil. The weight ratio of a):b): c) ranges from about 1:1:1 to about 5:1:99. The above composition is made of 30±5% Boswellia extract, 10±5% extract of Curcuma longa or curcuminoid composition and 60±5% sesame oil by weight.”([0054]).
Regarding the particle size, Benny teaches that the analgesic and anti-inflammatory composition has particles having a particle size ranging from less than about 20 micrometers to about 1 micrometer, which is fully within the claimed range of 200 micrometer to about 100 nanometers (e.g. 0.1 micrometer).
Regarding claim 4, Benny expressly teaches that the mixture of Turmeric and Boswellia extract is blended in a ratio between 1:10 to 1:1 ([0055]).
Regarding claims 5 and 7, Benny teaches that the turmeric extract comprises at least 80% curcuminoids (Table 9, [0203]), and the Boswellia extract comprises at least 10% Acetyl-11-keto-beta-boswellic acid ([0020] ,[0027]). Arriving at the claimed values in claim 5 would have been prima facie obvious over the disclosure in Benny, as this appears to be essentially the same composition as the one taught therein.
Concerning claim 6, similar ratios of these extracts are taught in Benny ([0055]).
Regarding claim 8, Benny teaches that the Boswellia extract is obtained from Boswellia gum resin and comprises at least Acetyl-11-keto-beta-boswellic acid (AKBA), as claimed therein ([0053]). Further, Benny teaches that the turmeric plant extract includes curcumin, demethoxycurcumin and bisdemethoxycurcumin ([0021]).
Regarding claims 9 and 10, Benny teaches that the composition is made into a dosage form for oral administration, selected from capsule, paste, ointment, infusion, injection, ampoule, solution, suspension, emulsion, oil, or cream., and that the composition is administrable to human beings at a dose of 50 mg to about 2000 mg.
Regarding the selection for the oil, Benny expressly teaches sesame oil, but also discusses olive oil, rice bran oil, and coconut oil, cotton seed oil, and Boswellia fat were tested ([0129]-[0131]; Table 4).
Regarding the preparation of the composition, as recited in the instant claim 18, Benny teaches a method for preparing the composition that includes: (1) mixing Boswellia extract (powder) and curcuminoid composition (powder) in 3:1 ratio, (2) blending this mixture with sesame oil in 2:3 ratio by weight, (3) passing the blend through a bead mill, (4) checking for particle size of the blend and pass blend through bead mill till the average particle size of less than 5-2 μm is obtained ([0082]; [0094], FIG. 6). Benny also teaches that an antioxidant may be added to the composition at an amount of 2000 ppm as a preservative ([0082], [0121]).
However, Benny does not expressly teach that the composition has a hydrophilic-lipophilic balance value ranging from 10 to 19, nor does this reference explicitly teach that the analgesic and anti-inflammatory composition can be used for treating dysmenorrhea (e.g. menstrual cramps), as required of the instant claims.
Sripathy discloses highly bioavailable, water soluble, sustained release nanoformulations comprising a hydrophobic plant derived compounds in an emulsifier phase, and aqueous phase (Abstract). Sripathy teaches formulating these sustained release nanoformulations containing unique proportion of the hydrophobic plant derived compound(s) in an emulsifier phase and aqueous phase to achieve ideal hydrophilic-lipophilic balance (HLB) for providing sustained release over a 24 hr time period and more ([0003]). Sripathy teaches that solubility, absorption, and bioavailability are well-known problems with delivery of curcumins and derivatives like bisdemethoxycurcumin, demethoxycurcumin, bis-o-demethylcurcumin ([0009]-[0011]). Sripathy teaches that plant extracts used therein are selected from but not restricted to Curcuma longa extract, curcumin, demethoxycurcumin, bisdemethoxycurcumin, bis-o-demethylcurcumin, and derivative of curcumin, Boswellia serrata extract, Boswellic acids ([0029]; [0061]).
Regarding the desired HLB, Sripathy teaches that “The higher the HLB value the more water soluble or hydrophilic the emulsifiers are. Hence, it is important that the nano formulations developed ideally comprise emulsifier(s) with a HLB value ranging from 13-18 to achieve enhanced bioavailability and sustained release.” Therefore, Sripathy teaches that optimal bioavailability is achieved with an HLB within the claimed range of HLB value, 10 to 19.
Tabari et al. pertains to a research study to investigate the effect of curcumin (turmeric) capsule on severity and duration of dysmenorrhea (Title, Abstract). Tabari teaches that curcumin obtained from the turmeric plant is known for its natural anti-inflammatory properties which is due to its effects in inhibiting the synthesis of prostaglandins F2 & E2, nuclear factor (NF-KB), and cyclooxygenases (pg. 3446, left col). This reference also teaches that the secretion of prostaglandins into the uterine tissue, especially in the anti-inflammatory mediators such as PGF2 and PGE2 plays a major role in uterine contractions underlying dysmenorrhea (pg. 3446, left col.). Tabari teaches that the pain intensity score was lowered for the group taking the curcumin (turmeric extract) treatment (see Table 2. Comparison Mean of the Two Groups, Pain Duration, and Severity on pg. 3449). Tabari concludes that “Curcumin is effective in reducing the pain caused by dysmenorrhea. It can be used as an herbal treatment to reduce the severity and duration of dysmenorrhea.” (Abstract, CONCLUSIONS on pg. 3445, pg 3449, last paragraph).
Therefore, before the effective filing date of the instant invention, to one of ordinary skill in the art, it would have been prima facie obvious to administer the composition of Benny, comprising an extract of Boswellia, an extract of Curcuma longa (i.e. turmeric extract), and a sesame seed oil, wherein the ratio of the Boswellia to are in 1:1 to 1:99 ratio by weight and the compositions has a particle size ranging from less than about 20 micrometers to about 1 micrometer, for the treatment of primary dysmenorrhea as taught in Tabari, and wherein the composition has a HLB value between 13-18 to achieve enhanced bioavailability and sustained release according to the teachings of Sripathy.
The turmeric, Boswellia, and sesame oil composition taught in Benny appears to be essentially identical to that of the instant claims, except for there being no express teaching regarding the HLB value. One of ordinary skill would have been motivated to determine the hydrophilic-lipophilic balance of an oil-emulsion based composition based on the teachings of Sripathy, and would have likewise been motivated to ensure this HLB value was at a suitable level for improved bioavailability, because this is taught expressly in Sripathy for compositions including hydrophobic plant extracts including curcumin, curcuminoid derivatives, and Boswellia extracts. Regardless, it would have been predictable that a similar composition would have similar properties, and it would have been obvious to adjust said HLB value if necessary because both Sripathy and Benny discuss emulsions of these plant extracts in oil, analogous to that of the instant application. The issues regarding bioavailability of curcumin, and other such hydrophobic extracts, are well-known in this art, and the encapsulating of such extracts with oil to form particles is taught in both references.
Regarding the claimed use of the plant extract and oil composition taught in Benny, Benny teaches generally that the composition has anti-inflammatory and pain-relieving properties. Although Benny doesn’t expressly teach administering the composition for the treatment of dysmenorrhea, such methods for using anti-inflammatories are known in the art. Tabari teaches successfully using a turmeric extract comprising curcumin for the treatment of pain related to dysmenorrhea, and thus one would have been motivated to use the anti-inflammatory and analgesic composition of Benny, containing a turmeric extract comprising curcumin as one of its primary active ingredients, in a similar manner.
MPEP § 2143.G (KSR Rationale G) discusses that one rationale to support a conclusion that the claim would have been obvious is that "a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so." Here, the reference Tabari suggests using a similar anti-inflammatory curcumin containing drug for treating dysmenorrhea, and demonstrates success in doing so, as evidenced by the data. Thus, one would have been motivated with a high expectation of success, to use the similar turmeric-extract containing drug of Benny for the same purpose (see also In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986)).
Regarding claims 2 and 23, Benny teaches that the composition comprises 30±5% Boswellia extract, 10±5% extract of Curcuma longa or curcuminoid composition and 60±5% sesame oil by weight, each of which is within the claimed amounts.
Regarding claims 3 and 24, Benny teaches that the sesame oil is about 60 wt%, but does not expressly teach these values for the turmeric extract and Boswellia extract. Regardless, the optimization of concentration is routine in the art. MPEP § 2144.05 describes that the determination of suitable or effective concentration of a known composition (or performing a known method) can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. 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, 456, 105 USPQ 233, 235 (CCPA 1955). Because there is no convincing evidence of the criticality of these proportions of the ingredients amount to unexpected success, these claimed values are considered obvious over those taught in Benny.
Regarding claim 4, Benny expressly teaches that the mixture of Turmeric and Boswellia extract is blended in a ratio between 1:10 to 1:1 ([0055]).
Regarding claims 5 and 7, Benny teaches that the turmeric extract comprises at least 80% curcuminoids (Table 9, [0203]), and the Boswellia extract comprises at least 10% Acetyl-11-keto-beta-boswellic acid ([0020] ,[0027]). Arriving at the claimed values in claim 5 would have been prima facie obvious over the disclosure in Benny, as this appears to be essentially the same composition as the one taught therein.
Concerning claim 6, similar ratios of these extracts are taught in Benny ([0055]).
Regarding claim 8, Benny teaches that the Boswellia extract is obtained from Boswellia gum resin and comprises at least Acetyl-11-keto-beta-boswellic acid (AKBA), as claimed therein and that the turmeric plant extract includes curcumin, demethoxycurcumin and bisdemethoxycurcumin, thus these limitations would have been obvious properties.
Regarding claims 9 and 10, Benny teaches that a dosage form for the composition can be hard gel capsule, soft gel capsule, paste, ointment, infusion, injection, ampoule, solution, suspension, emulsion, oil or cream, and that the dosage can be in a range of 50 to 2000mg, thus fully encompassing the claimed range of 500mg to 2000mg. Because the claimed dosage substantially overlaps with that taught in the referenced art, it would have been obvious.
For claims 11, 19, and 20, Benny expressly teaches a composition wherein the oil comprises sesame oil, and thus this would have been an obvious oil (e.g. edible oil) to provide.
Regarding claim 18, all of the steps that are instantly claimed are recited in Benny (mixing Boswellia extract (powder) and curcuminoid composition (powder) in 3:1 ratio; blending this mixture with sesame oil in 2:3 ratio by weight; passing the blend through a bead mill, checking for particle size of the blend and pass blend through bead mill till the average particle size of less than 5-2 μm is obtained). Benny does expressly teach that there is a high viscose blend nor that there is a yellow colored liquid with a viscosity in the range of 270 to 320 mP·S. Following the method steps used in Benny to produce essentially the same composition that is used in the method of the instant claim would have predictably resulted in mixtures having these claimed properties. Further, the claim is directed to a method of administering the composition, not to the method of making the composition, per se. The teachings of Benny, Sripathy, and Tabari would have rendered obvious the method of administering the composition for the treatment of dysmenorrhea. These silent properties are herein recited only as part of the preparation method and are not deemed to result in a treatment method that is patentably distinct from the one made obvious by the cited art. Administration of essentially the same compound is still obvious, regardless of precisely how that compound was obtained, unless there is convincing evidence on the record that the method of making the composition would have resulted in new structural properties or unexpected results. Here, the adjustment of viscosity (i.e. due to the inclusion of oil and the generation of microparticles) is known in the art, and unless shown to be critical, will not result in a finding of nonobviousness, when the rest of the administration method is deemed obvious.
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because Sripathy and Benny discuss similar emulsions of plant extracts in oil, which are analogous to that of the instant application, while Sripathy demonstrates the effect of HLB on bioavailability, and because Tabari successfully demonstrates treating dysmenorrhea with a composition containing curcumin.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Claim 2-11, 17-21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over “Benny” (US PGPub No. 20200384060), Sripathy et al. (US PGPub No. 20150072012, herein “Sripathy”) and Tabari et al. (J Evolution Med Dent Sci, 2020), as applied to claims 2-11, 17-20, 23, and 24 above, and further in view of Senanayake ("Green tea extract: Chemistry, antioxidant properties and food applications–A review." Journal of functional foods 5.4 (2013): 1529-1541), to include the rejections of claim 21.
The combination of Benny, Sripathy, and Tabari renders obvious the method of reducing menstrual cramp pain and treating primary dysmenorrhea by administering a composition comprising turmeric extract and Boswellia extract in sesame oil, having the recited properties, for all of the reasons discussed above. Regarding the preparation of the composition, Benny teaches a method for preparing the composition that includes: (1) mixing Boswellia extract (powder) and curcuminoid composition (powder) in 3:1 ratio, (2) blending this mixture with sesame oil in 2:3 ratio by weight, (3) passing the blend through a bead mill, (4) checking for particle size of the blend and pass blend through bead mill till the average particle size of less than 5-2 μm is obtained ([0082]; [0094], FIG. 6).
Regarding the additional limitations of claim 21, Benny also teaches that an antioxidant may be added to the composition at an amount of 2000 ppm as a preservative ([0082], [0121]).
However, Benny does not expressly teach that the antioxidant comprises a combination of rosemary and green tea extract, as required of claim 21.
Senanayake pertains to food applications of green tea extracts, and discusses similar effective antioxidant compounds (Title, Abstract). Senanayake teaches that green tea extract can also be used in lipid-bearing foods to delay lipid oxidation and to enhance the shelf-life of various food products (Abstract). This reference teaches that lipid oxidation and development of rancidity is a major challenge for food manufacturers, reducing shelf-life and altering the quality and nutritional value of their products containing lipids (pg. 1532, right col, section 4). Senanayake reviews various studies discussing the food preservative aspects of green tea extract and rosemary extract (see pages 1535-1536). In one study, rosemary extract (1000ppm) and green tea extract (250ppm) were used as preservatives to prevent oxidation of raw ground beef (pg. 1536, left col, Fig. 5). In another, these compounds were studied for enhancing the oxidative stability of chicken nuggets during refrigerated (4°C) storage (see pg. 1535, right col, last para spanning to pg. 1536).
Thus, to one having ordinary skill in the art, before the filing date of the instant invention, it would have been obvious in view of the combined teachings of Benny, Sripathy, Tabari, and Senanayake to perform a method for treating menstrual cramp pain as claimed, wherein the composition includes an edible oil comprising antioxidants at a level of 2000 ppm, as taught in Benny, and wherein the antioxidants comprise green tea extract and rosemary extract, which are both taught in Senanayake to improve the shelf-life of lipid containing products.
One would have been motivated to include antioxidants because Benny teaches providing such antioxidants at a level of 2000ppm for increasing storage stability and Senanayake teaches that antioxidants including green tea extract and rosemary extract are known in the art for increasing the shelf life of fat/lipid containing foods and supplements. Because it is evident that the compositions used in the methods suggested by the teachings of Benny, Sripathy, and Tabari, would be abundant in lipids (i.e. having ~60% edible oil by weight), it would have been obvious to include the natural antioxidants of green tea extract and rosemary extract as preservatives. The selection of these antioxidants would have been a matter of judicious selection to one of ordinary skill in the art.
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings therein to arrive at the claimed invention because Benny teaches essentially identical emulsions of plant extracts in oil that include preservative antioxidants while Senanayake demonstrates that green tea and rosemary extracts are known preservatives that improve the shelf life of lipids by inhibiting oxidation.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Martin (US PGPub No. 20180280464) discloses analgesic compositions that include various ingredients in synergistic quantities, and most preferably a turmeric component and a Burseraceae extract (Abstract, [0017]). Martin teaches that the turmeric component may comprise a turmeric extract, a curcumin, a desmethoxycurcumin, a bis-desmethoxycurcumin, a rosocyanine, and a curcumin phosphatidylcholine complex and that the Burseraceae component can comprise at least one of a Boswellia extract, a Boswellia gum resin, or a boswellic acid ([0017]). Martin also suggests that the treatment of pain and inflammation can include the treatment of premenstrual/menstrual pain ([0026]).
Pichardo et al. ("ESCAPE pain trial-The effects of Curcumin in pain relief in women diagnosed with primary dysmenorrhea: A triple blinded, placebo-controlled, phase II, randomized clinical trial protocol." Principles and Practice of Clinical Research 6.2, 2020, hereafter “Pichardo”) discusses a research study to assesses the efficacy of curcumin for pain relief among women with primary dysmenorrhea, using a controlled clinical trial to evaluate the effect of curcumin (500 mg/12h) in pain reduction in women (18 to 35-year-old) with primary dysmenorrhea (Title, Abstract). This reference concludes by stating “Based on previous research, curcumin is considered a good, safe for consumption and affordable candidate for acute-cyclic pain and disabling conditions such as primary dysmenorrhea, turning it to a possible choice among women with allergies or that do not respond to NSAIDs as pain relief aid, increasing options for women to choose the treatment that best fits them” (pg. 31, left col., last paragraph).
Eshaghian et al. (“The effect of frankincense (Boswellia serrata, oleoresin) and ginger (Zingiber officinale, rhizoma) on heavy menstrual bleeding: A randomized, placebo-controlled, clinical trial.” Complementary therapies in medicine vol. 42. 2019) discusses trials involving tested an extract of Boswellia serrata on patients suffering from heavy menstrual bleeding, or HMB (Title, Abstract). This reference suggests a role of prostaglandin E2 (PGE2) in the disorder (pg. 42, Introduction) and teaches that Frankincense is another herb which is recommended for the treatment of HMB in Persian medicine and has been shown to have anti-inflammatory properties (pg. 43, left hand col). This reference teaches that the anti-inflammatory effects of boswellic acid and its derivatives are through the inhibition of LOX, nitric oxide synthase, COX-2, and prostaglandins, and concludes that frankincense can be considered as an adjuvant therapy for the management of HMB (see pg. 46, left-hand col).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Prosecution Insights