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
Applicant’s amendment in the reply filed on 5/4/26 is acknowledged, with the cancellation of Claim 7. Claims 1-6, and 8-20 are pending. Claims 1-6, and 8-20 are examined on the merits.
Any rejection that is not reiterated is hereby withdrawn.
For claim 7, a cancelled claim should be without any recitation of text.
Claim Objections
Claims 16 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 19 recites “said edible organic”, which is incorrect, the correct recitation should be “said edible organic substance”.
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 1-6, 8-15 and 20 remain 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.
This rejection is maintained for reasons of record set forth in the Office Action mailed out on 11/4/25, repeated below, slightly altered to take into consideration Applicant’s amendment filed on 5/4/26. Applicants’ arguments filed have been fully considered but they are not deemed to be persuasive.
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) 1-6, 8-15 and 20 is/are directed to an edible organically based substance comprising: a cannabis plant material; medium-chain triglyceride oil; and medium-chain triglyceride powder.
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, cannabis plant exists in nature, MCT oil or MCT oil powder, for example an extract from coconut oil, exists in nature as well. There is no indication that extraction has caused the components of coconut oil that comprise the claimed compositions to have any characteristics that are different from the naturally occurring components in coconut.
Step 2A. Prong two: Does the claims recite additional elements that amount to significantly more than the judicial exception?
No. The claim(s) of 1-6, 8-15, and 20 does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Regarding claims 1-5, and 11-15, 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 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 6, and 8-10 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 the term “edible”, oral consumption or administration does not result in a markedly different characteristic because an organic material such as cannabis already has the characteristic of being in a form suitable for oral consumption.
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.
Applicant argument on pages 9-11 have been carefully considered, but are not found persuasive. First of all, the argument point is not about whether the combination exists in nature or not, it is all about whether the combination imparts any characteristics that are different from the naturally occurring counterparts. As stated above, regarding claims 1-5, and 11-15, 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 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. If Applicant could add specific amount to each of the three claimed component, and demonstrate what special effect the combination has, whereas each component itself doesn’t have that special effect, then the rejection could be overcome.
Applicant's arguments have been fully considered but they are not persuasive, and therefore the rejections in the record are maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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 8:30 am to 5:00 pm.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655
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