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
Election/Restrictions
Claims 31-57 are pending.
Applicant’s election of Claims 31-57 in the reply filed on 9/17/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 31-57 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 31-57 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) 31-57 is/are directed to A composition for supporting, maintaining, or improving liver health comprising: about 15% to about 25% of Andrographis paniculata extract; about 5% to about 15% of Zingiber officinale (ginger) extract; about 5% to about 15% of Brassica rapa (turnip) extract; about 25% to about 35% of Momordica charantia extract; about 10% to about 20% of Asparagus racemosus extract; and about 10% to about 20% of Phyllanthus niruri extract; each by weight relative to the total weight of the composition.
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, Andrographis paniculata extract; Zingiber officinale (ginger) extract; Brassica rapa (turnip) extract; Momordica charantia extract; Asparagus racemosus extract; and Phyllanthus niruri extract, because there is no indication that extraction has caused the components of those extracts that comprise the claimed compositions to have any characteristics that are different from the naturally occurring components in Andrographis paniculata; Zingiber officinale; Brassica rapa; Momordica charantia; Asparagus racemosus; and Phyllanthus niruri.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 31-57 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Claims 9-14, and 33 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.
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 § 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 31-57 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 31 recite parenthetical expression "(ginger)" at line 3, and “(turnip)” at line 4. The metes and bounds of Claim 31 are rendered vague and indefinite by the parenthetical recitations because it is unclear as to whether the limitation is part of the instantly claimed subject matter. Claims 32-34, and 57 are rejected for the same reason.
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.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached on 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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