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
Claims 1, and 3-24 are pending. Claims 1, and 3-24 are examined on the merits.
The correct status of claim 2, should be “cancelled” (without any text).
Claim Rejections –35 USC § 112, 2nd
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 3, 7-14, 17, and 18 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 3 recites “wherein the composition comprising curcuminoids provides curcuminoids in an amount of from about 50 mg/dose to about 300 mg/dose”. The recitation is very confusing, isn’t redundant to recite “curcuminoids provides curcuminoids”? Claim 8 is rejected for the same reason.
Claim 7 recites “The composition method to claim 3…” at line 2, the recitation is very confusing, as claim 3 is a method claim, instead of a composition. Does Applicant mean to say “the method of claim 3”?
Claim 8 recites “…in an amount of form about 50 mg/dose to about 300 mg/dose” at last two lines. The recitation is confusing, as claim 8 is a composition claim, the how the composition is being administered does not further limit the composition.
Claim 9 recites “wherein the curcuminoids are curcumin and its phase I or phase II metabolites, demethoxycurcumin and its phase I or phase II metabolites, bisdemethoxycurcumin and its phase I or phase II metabolites and mixtures thereof” (at lines 2-4). The recitation is very confusing, as it is not clear what phase I or phase II metabolites of curcumin, demethoxycurcumin, and bisdemethoxycurcumin encompass.
Claim 10 recites “The method according to claim 9, wherein curcuminoids are selected from curcumin, demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC) and mixtures thereof”. The recitation is very confusing, as claim 10 depends upon claim 9, wherein claim 9 is supposed to contain all of curcumin, demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC), not only some of them.
Claim 11 recites “The method of claim 3, wherein the composition comprises an amount of curcuminoids from 30 mg, 40 mg, 45 mg, 50 mg, 55 mg, 60mg, 65mg, 70mg, 75mg, 80mg, 85mg or 90mg to about 1500mg, 1400mg, 1200mg, 1110mg, 1000 mg, 900mg, 800mg, 700mg, 600mg, 500mg, 400mg, 300mg, 250mg, 200 mg, 150 mg, 100 mg or 95mg”. The recitation is confusing, after “90 mg”, shouldn’t Applicant recites “95 mg” instead of “1500 mg”? why the numbers are not in an ascending order? Claims 13 and 17 are rejected for the same reason.
Claim 12 recites “The composition of claim 3”. The recitation is confusing, as claim 3 is a method claim, instead of a composition claim. Does the Applicant mean to say “The method of claim 3, wherein the composition…”?
Claim 14 recites “The method of claim 3, wherein the one or more saponin(s) is selected from quillaja saponin(s), yucca saponins, tea saponins, peanut saponins, spinach saponins, sugar beet saponins, yam saponins, blackberry saponins, liquorice root saponins, primula root saponins, ginseng saponins and mixtures thereof”. The correct Markush group recitation should be “The method of claim 3, wherein the one or more saponin(s) is selected from the group consisting of quillaja saponin, etc.”.
Claim 18 recites “The method of claim 3, wherein the composition dosage is from about 100 mg to about 500 mg, and the daily dose of curcuminoids is from about 50 mg/day to about 500 mg/day. The recitation is confusing, as in claim 3, the dosage is 50 mg/dose to about 300 mg/dose. Thus the dose in claim 18 is outside the range of in claim 3.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above.
Claim Rejections –35 USC § 112, 4th
The following is a quotation of the fourth paragraph of 35 U.S.C. 112:
Subject to the following paragraph, a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 10 and 18 is/are rejected under 35 U.S.C. 112, fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
Claim 10 recites “The method according to claim 9, wherein curcuminoids are selected from curcumin, demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC) and mixtures thereof”. However, claim 10 depends upon claim 9, wherein claim 9 is supposed to contain all of curcumin, demethoxycurcumin (DMC), bisdemethoxycurcumin (BDMC), not only some of them. Therefore, claim 10 does not further limit claim 9.
Claim 18 recites “The method of claim 3, wherein the composition dosage is from about 100 mg to about 500 mg, and the daily dose of curcuminoids is from about 50 mg/day to about 500 mg/day. However, in claim 3, the dosage is 50 mg/dose to about 300 mg/dose. Thus the dose in claim 18 is outside the range of in claim 3, and claim 18 does not further limit claim 3.
Claim Rejections –35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4, and 8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
First, the claimed invention must be to one of the four statutory categories. 35 U.S.C. 101 defines the four categories of invention that Congress deemed to be the appropriate subject matter of a patent: processes, machines, manufactures and compositions of matter. The latter three categories define "things" or "products" while the first category defines "actions" (i.e., inventions that consist of a series of steps or acts to be performed). See 35 U.S.C. 100(b) ("The term ‘process’ means process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material."). See MPEP § 2106.03 for detailed information on the four categories.
Second, the claimed invention also must qualify as patent-eligible subject matter, i.e., the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena (including products of nature). Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) (citing Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589, 106 USPQ2d 1972, 1979 (2013). See MPEP § 2106.04 for detailed information on the judicial exceptions.
Claim(s) 1, 4, and 8 is/are directed to a composition comprising i) curcuminoids; ii) modified starch and/or acacia gum; and iii) one or more saponins for use in improving and/or maintaining functional performance and/or relieving, treating, and/or decreasing and/or preventing muscle soreness in a subject during and/or after exercise, wherein the composition comprising curcuminoids may be administered or used to provides curcuminoids in an amount of from about 50 mg/dose to about 300 mg/dose.
Analysis of the flowchart:
Step 1, is the claim directed to a process, machine, manufacture or composition of matter?
Yes. The claim is directed to a composition of matter.
Step 2A. Prong one: Is the claim directed to a law of nature, a natural phenomenon (product of nature), or an abstract idea?
Yes, the claims are directed to nature based components, curcuminoids exists in turmeric root; acacia gum exists in genus acacia, saponins exist in quillaja, yucca tea, peanut, spinach, sugar beet, yam, baackberry, liquoric root, primula root, ginseng, because there is no indication that extraction has caused the components of turmeric, acacia, and quillia that comprise the claimed compositions to have any characteristics that are different from the naturally occurring components in turmeric, acacia, and quillia.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1, 4, and 8 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claim 4, since there is no absolute amounts of the active ingredients are claimed as compared to the whole composition, the claimed composition encompasses embodiments where the active ingredients are in such small amounts that none of them impart any characteristic or markedly different characteristic. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
Claims 1, and 8 require certain amounts of components being present in the composition. However, there is no indication that the amounts claimed in the compositions result in a markedly different characteristic for the composition as compared to the components that occur in the nature.
Regarding claim 4, oral consumption or administration does not result in a markedly different characteristic because turmeric, acacia, and quillia already have the characteristic of being in a form suitable for oral consumption, and thus have that same characteristic.
Step 2B. If additional elements of the claim provide an inventive concept (Step 2B) (also called "significantly more" than the recited judicial exception).
No, no non-nature based components were recited in the claims.
For the reasons described above, the claimed compositions are not markedly different from their closest naturally occurring counterparts and thus are product of nature judicial exceptions.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed compositions themselves. Also, this is a product claim and since there are no claimed method steps, there are no additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception themselves. Therefore, the claims do not recite something significantly more than a judicial exception and are thus deemed patent ineligible subject matter.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, and 3-24 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Birtic et al (WO 2020030611 A1).
Birtic et al teach compositions comprising at least about 20% curcuminoids, arabic gum (i.e. acacia gum) and a quillaja extract (thus claim 14 is met) comprising at least 50% saponins (claims 1 and 6; example 2; p. 33, Il. 17-19) (thus claim 1 is met). Acacia gum is present in an amount of 40-65% (thus claim 13 is met), Quillaja saponins are present in an amount of from 0.1% to 5% (see p. 8, lines 27-35) (thus claim 15 is met). The composition can be in various forms for oral administration (see claims 8-12) (thus claim 4 is met). The compositions comprise particles of a diameter of 100-1000 nm (see claim 1) (thus claim 16 is met). In in-vivo tests, the composition is administered at a dose of 300 mg/dose (see p. 113, lines 10-16) (thus claims 1 and 3 are met). Alternative dosages are described (see p.15, lines 15-27). The compositions comprise curcumin, DMC and BDMC (see Page 34, table 2) (thus claims 9 and 10 are met). The curcuminoids are provided by extraction from the root (rhizome) of Turmeric (Curcuma longa), oleoresin Turmeric root, defatted oleoresin turmeric root or mixtures thereof (see p. 7, lines 15-21) (thus claim 12 is met).
Birtic et al teach typically, the composition of the invention or the nutraceutical formulation (thus claim 21 is met), a dietary or food product for humans (thus claim 22 is met) or animals (such as functional food formulations, i.e. food, drink, feed or pet food or a food, drink, feed or pet food supplements), a nutritional supplement, a fragrance or flavouring, a pharmaceutical or veterinary formulation, an oenological or cosmetic formulation is administered to provide curcuminoids in an amount of from about 100 mg/day (thus claim 11 is met) to about 2000 mg/day, or from about 500 mg/day to about 1500 mg/day, or about 1000 mg/day, such as from about 300 mg/day (thus claims 17 and 18 are met) to about 1000mg/day (page 15, lines 15-21).
Birtic et al teach to assess plasmatic concentrations profile of total curcuminoids (curcumin, demethoxycurcumin (DMC), bisdemethoxycurcumin (DBMC) and their metabolites) on a 24 hours period after consumption of a single dose of 300 mg of composition of the invention (thus claims 20 and 24 are met) claims (Turmipure GOLD™ 30% curcuminoids formulation) compared to 1500mg Standard turmeric powder extract 95% curcuminoids (page 61, lines 1-6).
Birtic et al teach the composition can be used for improving joint health and arthritis, and thus for improving functional performance (see p. 55, lines 1-5) (thus claims 3, 5-7 are met). The composition provides a better bioavailability as comparative curcuma compositions (see p. 113, lines 1-16).
Birtic et al teach investigation of gender effect, wherein Gender including female or male (page 71, lines 13-23) (thus claim 23 is met).
Birtic et al teach turmeric extract contains approximately 75-80% curcumin, 15-20% demethoxycurcumin (DMC), and 0-10% bisdemethoxycurcumin (BDMC) (see Figure 1). Birtic et al teach doses were calculated to fed animals with 300mg/kg of total curcuminoids (see table 8). Birtic et al teach this dosage in mice is equivalent to 21.37mg/kg in humans and 1282 mg assuming a 60 kg human (page 47, lines 17-20). Therefore, for a rat that weighs 250 g, the dose amount of 300 mg/4, which equals to 75 mg, when curcumin is 75-80 % is curcumin, 15-20% demethoxycurcumin (DMC), and 0-10% bisdemethoxycurcumin (BDMC), claim 19 is met.
The intended use of the composition was analyzed for patentable weight. It is deemed that the preamble ‘breathes life’ into the claims in that the prior art product must not be precluded for use for the treatment of muscle pain and/or muscle fatigue in a subject after exercise (thus claim 4 is met), or for decreasing the levels of creating kinase in a subject during and/or after exercise or in the preventing the increase of the levels of creatine kinase in a subject during and/or after exercise (thus claim 8 is met). It is deemed that the composition disclosed by the cited reference is not precluded for carrying out the intended function of the claims.
Therefore, the reference is deemed to anticipate the instant claim above.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QIUWEN MI whose telephone number is (571)272-5984. The examiner can normally be reached on Monday-Friday 9:00 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655