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 .
Claims 1-12 are pending in this application.
Applicant’s election of the invention of Group I, claims 1-12, in the reply filed on 6/19/2025 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 § 818.01(a)).
Claims 1-12 will presently be examined.
The disclosure is objected to because of the following informalities: the specification does not contain a BRIEF DESCRIPTION OF THE DRAWING(S) section.
Appropriate correction is required.
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 1-12 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.
(A) In claim 1, “oxygen-containing gas, in particular air” is indefinite language because it recites a broader category of gas followed by an example. The broad-to-narrow language raises uncertainty as to whether the example is merely exemplary or limiting.
(B) In claim 5, the duration of the first step is recited as “60-120 seconds, particularly preferably 80-100 seconds.” The particularly preferred duration, taken with the broader duration, raises uncertainty as to whether the preferred duration is exemplary or limiting.
(C) Similarly in claim 10, the second step is “a maximum of 20 seconds, preferably a maximum of 15 seconds, long.” The preferable feature, taken with the broader feature, raises uncertainty as to whether the preferable feature is exemplary or limiting.
Also, rephrasing is suggested regarding “long” with respect to step (5) in claim 10. Example: “The method according to claim 1, wherein the duration of the second step (5) is a maximum of 20 seconds.”
(D) The step in claim 11 is confusing and indefinite. There seems to be no connection (the way the claim is currently written) between the drum and the rest of the second step. Additional language is needed to clarify or define how the drum is related to the other components of the second step.
(E) Claims dependent on the rejected claims are included in this ground of rejection because they do not cure the deficiencies of their base claim(s).
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Himes et al. (US 2020/0030397; hereinafter, Himes), WO 2019/113187, and WO 2020/214859 in view of KR 100341798 B1, and Hiramoto et al. (US 2007/0009640).
Himes discloses a method and apparatus for harvesting trichomes from cannabis plants (abstract; paragraphs 2, 25). Trichomes are located on, inter alia, the flowers of cannabis plants (paragraph 3). Himes’ method exposes the cannabis biomaterial, including flower material, to cryogenic liquid such as liquid nitrogen (paragraphs 5-8 in view of paragraph 39; see also paragraph 26). The cannabis plant material can be frozen directly after harvesting (paragraph 27). Himes separates or screens the trichomes from the rest of cannabis plant material (paragraphs 29-31). However, Figure 2 shows that a second vibratory screening is carried out to discharge flower material, whereas Figure 1 shows only one vibratory screening. Thus, Figure 1, step 114, would include at least some flower materials with trichomes because a second screening step is not used in the embodiment represented by Figure 1. The frozen state of plant material is at ≤ -45 °C (paragraphs 8, 18). For continuous freezing, the cannabis plants or pieces are loaded on conveyor belts through a freezing zone, for example in a tunnel freezer (paragraph 40).
WO 2019/113187 discloses processing plant matter such as freshly cut cannabis, including flowers and buds (paragraphs 22, 28, 31, 89-90) by exposing it to liquid nitrogen (paragraphs 26, 32), and then freeze drying the plant matter (paragraph 90).
WO 2020/214859 discloses using liquid nitrogen to freeze cannabis plant matter (paragraph 42) and dehydrating the cannabis plant matter by a method that includes lyophilization (paragraph 49).
KR 100341798 B1 and Hiramoto et al. (US 2007/0009640) are cited to establish that other plant materials are known to be processed by freezing in liquid nitrogen and then lyophilizing. In KR 100341798 B1, Agastache rugosa, including its flowers, is rapidly frozen in liquid nitrogen for 15 minutes and then lyophilized to provide a dried sample (see the machine translation, Example 1). In Hiramoto et al., various plant matters such as tea leaves, vegetables, fruits, or flowers (paragraphs 1, 9, 11-14) are processed by freeze-drying, wherein the term “freeze-drying” includes freezing by exposing to liquid nitrogen and then using a freeze dryer (paragraph 38).
The cited prior art references do not explicitly disclose a method of treating cannabis flowers exactly as claimed herein, but the claimed invention would have been obvious to the ordinary skilled artisan for the reasons set forth below.
Claim 1: first (3,4), second (5), and third (7) steps
These steps are written broadly enough to read on first freezing in liquid nitrogen and then freeze drying. The step of freeze drying, as suggested by WO 2019/113187, WO 2020/214859, KR 100341798 B1, and Hiramoto et al. include bringing the liquid nitrogen-frozen sample to the freeze dryer, which would obviously expose the sample to oxygen-containing air.
Claim 2: cannabis flower is harvested immediately before first step
Himes teaches freezing directly after harvesting. The ordinary skilled artisan would have been motivated to freeze immediately after harvest to preserve freshness and minimize degradation.
Claim 3: cannabis flower is immersed in a bath with liquid N2 in the first step
Processing of plant matter that contains desirable extractable materials is known to include flash freezing in liquid nitrogen followed by freeze drying. Immersion in a liquid nitrogen bath would have been obvious.
Claim 4: cannabis flower is guided through a nitrogen bath on a conveyor belt
in the first step
Himes teaches continuous freezing, wherein the cannabis plants or pieces are loaded on conveyor belts through a freezing zone, for example in a tunnel freezer (paragraph 40). A nitrogen bath in the tunnel freezer would have been obvious for providing the freezing zone because Himes teaches the use of liquid nitrogen.
Claim 5: duration of the first step is 60-120 seconds or 80-100 seconds
KR 100341798 B1 teaches rapid freezing of plant material in liquid nitrogen for 15 minutes. The ordinary skilled artisan would have recognized that duration of contact time with liquid nitrogen would depend on factors such as quantity of plant materials to be frozen quickly and amount/volume of liquid nitrogen. Such variation and optimization would have been obvious to the ordinary skilled artisan, and he/she would have found it obvious to contact at least one cannabis flower with liquid nitrogen for 80-100 seconds to obtain frozen cannabis flower for subsequent freeze drying when such duration would provide acceptably frozen cannabis flowers.
Claim 6: relative speed between the cannabis flower and oxygen-containing gas in the second step is 2-3 m/s
This feature relates to how quickly the liquid nitrogen-contacted cannabis flower
is removed from the liquid nitrogen and delivered to a freeze dryer. 2-3 m/s is equivalent to approximately 4.5 miles/hour, or stated differently, a speed of about 13.4 minute/mile. Thus, such speed of moving the frozen sample from liquid nitrogen to a freeze dryer would have been obvious so that the frozen sample is not unfrozen in transition.
Claim 7: oxygen-containing gas has humidity of 40-80% or 50-70%
This is a humidity level that can be normal, especially during the warmer
months. The step of taking the flower sample out of contact with the liquid nitrogen and using a freeze dryer would necessarily expose the flower to oxygen-containing air, which would have the humidity level claimed in the warmer months of the year.
Claim 8: the gas in second step has a maximum temperature of 20 °C
The ordinary skilled artisan would have been motivated to transfer the liquid nitrogen contacted cannabis flower to a freeze dryer without melting. Thus, the ordinary skilled artisan would have found it advantageous to have the air temperature be cool or cold so as to minimize melting or thawing.
Claim 9: leaves are removed from at least one cannabis flower during the
second step
Himes teaches removing cannabis leaves, as discussed above. Removing any part of the cannabis plant material would depend on the intended use and/or further treatment of the plant parts. For a product focused on cannabis flowers and buds, removal of leaves would have been obvious.
Claim 10: second step takes maximum of 15 seconds or 20 seconds
Similar to the feature set forth in claim 6, this feature describes how quickly the liquid nitrogen-contacted cannabis flower is moved to a freeze dryer. As stated previously, such speed would have been obvious so that the frozen sample is not unfrozen in transition.
Claim 12: cannabis flower is cooled between the second and third step
In the event the step of moving the frozen sample, i.e. cannabis flower, to a freeze dryer warms the frozen sample too much, it would have been obvious to refreeze or cool the sample for freeze drying.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, because every element of the invention and the claimed invention as a whole have been fairly disclosed or suggested by the teachings of the cited references.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699