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 1-24 are pending. Claims 1-24 are examined on the merits.
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 1-24 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) 1-24 is/are directed to a composition for improving unidentified complaints before and during menstruation comprising Apocynum venetum leaf extract as an active ingredient.
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, an extract of Apocynum venetum leaf, because there is no indication that extraction has caused the components of Apocynum venetum leaf extraction that comprise the claimed compositions to have any characteristics that are different from the naturally occurring components in Apocynum venetum leaf.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1-24 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claims 1, 4, 7, 10, 13, 16, 19, and 22, 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 2, 3, 5, 6, 8, 9, 11, 12, 14, 15, 17, 18, and 20-21 require certain amount 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.
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 1-24 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Nishibe et al (US 2002/0090403 A1).
Nishibe et al teach Apocynum extracts used in the present invention can be obtained by extracting leaves of Apocynum venetum L. with water, ethanol, ethanol hydrate or an organic solvent followed by concentration [0017] (thus claims 1, 4, 7, 10, 13, 16, 19, and 22 are met). Nishibe et al teach the Apocynum extract according to claim 1 containing not less than 4% of flavonoid compounds as expressed in the total content of hyperoside and isoquercitrin (see claim 2) (thus claims 2, 5, 8, 11, 14, 17, 20, and 23 are met). Nishibe et al teach the dose of pharmaceutical compositions of the present invention is generally 1 mg-2000 mg, preferably 1 mg-1000 mg daily per adult expressed as Apocynum extracts or 0.01 mg-300 mg expressed as total flavonoids [0025] (thus claims 3, 6, 9, 12, 15, 18, 21, and 24 are met).
Regarding claims 3, 6, 9, 12, 15, 18, 21, and 24, Applicant is noted that what is being claimed is a product, daily intake is a method of use, thus the dosage does not further limit the composition.
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 improving unidentified complaints before and during menstruation, for improving impaired concentration before and during menstruation, for improving depression before menstruation, for improving decreased motivation for socialization and daily activities before menstruation, for improving autonomic nervous system disorders before menstruation, for improving pain during menstruation, for improving control during menstruation, for improving sleep before menstruation. 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