DETAILED ACTION
This is the first action in response to US Patent Application No. 18/575,861, filed 01 January, 2024, as the National Stage Entry of International Application PCT/IL2022/050717 filed 05 July, 2022, and with priority to provisional application 63/218,514, filed 06 July, 2021.
The preliminary amendments filed 01 January, 2024, have been entered. Claims 1, 3-5 and 12-19 are amended. Claims 2 and 22-43 are cancelled. Claims 1 and 3-21 are pending and have been fully considered.
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 .
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, 3-5, 9, 14-16, and 21 are rejected under 35 U.S.C. 102(a)(1&2) as being anticipated by Novotny (US 2021/0052753 A1).
Regarding claim 1, Novotny teaches a method for decontamination of plant matter (method of reducing bioburden of cannabis material—[0118]; system 100 for purifying, i.e. sterilizing, plant product 110—[0039]) comprising:
Removing air from a chamber comprising plant matter (inserting organic cannabis material into the pressure chamber….performing a first pressure change of the pressure chamber to a first predetermined pressure which is a sub-atmospheric pressure—[0118]; product 110 placed in vacuum chamber 102—[0039]—and a purification process is initiated—[0050]—which includes evacuating the vacuum chamber 102—[0042]);
Contacting the plant matter with a sterilant while the plant matter is in the chamber, under a pressure lower than atmospheric pressure (introducing a purifying oxygen-based reagent into the pressure chamber in aerosol, vapor, or gas form and processing the organic cannabis material with the oxygen-based reagent for at least one cycle having a predetermined duration to reduce the bioburden of the organic cannabis material—[0118]; inject reagent 150 into vaporizer/aerosolizer 160 and introduce a reagent gas/vapor/aerosol into vacuum chamber 102—[0042]—and the product dwells for a sufficient time for the reagent to diffuse into the product—[0043]);
Reducing pressure by removing gas from the chamber (performing at least one second pressure change of the pressure chamber to a second predetermined pressure to remove residue of the oxygen-based reagent, the second predetermine pressure being a sub-atmospheric pressure—[0118]; one or more pressure variations –[0046])
Repeating steps b. and c. (note that paragraph [0118] indicates that steps b. and c. are performed “at least once”, thus fairly disclosing embodiments wherein they are repeated; cycle or series of cycles—[0043]; furthermore, Fig. 7F discussed below more clearly discloses repetition of steps b and c);
Removing the sterilant from the chamber to provide decontaminated plant material, wherein the plant matter is cannabis inflorescence (first venting, followed by second pressure change to a second predetermined pressure below atmospheric pressure to remove the oxygen-based reagent, and second venting… to produce a sanitized organic cannabis product—[0118]; cleaning step or cycle is performed involving one or more additional vacuum cleaning stages to eliminate residual reagent form the product 110—[0047]; organic plant material is cannabis plant material, including one or more of raw cannabis plant material, dried cannabis plant material, and/or cannabis flower—[0117]; it is noted that “inflorescence” is understood to be a botanical term referring to the flowering structure of plant, such that Novotny teaching cannabis plant material including cannabis flower fairly includes cannabis inflorescence).
Annotated Fig. 7F depicts a corresponding embodiment (see [0109]) which includes (a.) a first evacuation of a vacuum chamber holding a load, (b.) a first injection of a vapor is into the chamber at a pressure below 100 Torr followed by venting, (c.) a second evacuation of the vacuum chamber, (d.) repeating the injection of the vapor, venting, and evacuation of the chamber at least once, and (e.) venting the chamber with repeated vacuum pulses to remove sterilant from the chamber.
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It is emphasized that Novotny teaches that the load comprises cannabis flowers ([0103]), the load is exposed to the injected oxygen-based reagent ([0090]-[0091]) at a pressure below atmospheric pressure (see Fig. 7F, during injection/contact portion of step “b” pressure is between 10 and 100 Torr), and the injected “oxygen-based reagent” or “reactive oxygen” of Novotny refers to vaporized hydrogen peroxide ([0027]-[0028], [0042]) which is a sterilant.
Regarding claim 3, Novotny teaches the method according to claim 1. As best seen in Fig. 7F of Novotny (see annotated copy provided with respect to claim 1 above), step (a) of Novotny involves reducing the vacuum chamber pressure to a pressure of 0.5 Torr, such that the air is removed from the chamber of step a to a pressure of below 1.5 mbar (note that 1.5 mbar is approximately equal to 1.1 Torr, such that the 0.5 Torr of Novotny is within the claimed range of below 1.5 mbar).
Regarding claim 4, Novotny teaches that contacting the plant matter with a sterilant of step b comprises contacting the plant matter with a primary sterilant at a lower pressure (see Fig. 7F wherein a diffusion step occurs at a pressure below 100 Torr; injection is followed by three pulsed diffusion processes forming 3 valleys and 2 additional hills—[0109]) and subsequently contacting the plant matter with a gas (air) or a secondary sterilant at a higher pressure (the chamber pressure is then increased to a process high, forming a steep rise in the graph—[0109]; a first venting of the pressure chamber raises the pressure of the chamber to atmospheric pressure—[0118]; also see [0046] discussing varying the pressure to alter the state of the reagent; “venting” fairly implies allowing atmospheric air to flow into chamber, such that the plant matter is contacted with air at atmospheric pressure).
Regarding claim 5, Novotny teaches the method according to claim 1 wherein the sterilant comprises hydrogen peroxide (vaporized hydrogen peroxide—see [0027]-[0028], and [0042] as discussed with respect to claim 1 above).
Regarding claim 9, Novotny teaches the method according to claim 5, and further teaches the sterilant is a hydrogen peroxide solution having a content of hydrogen peroxide of between 15% and 35% by weight (infusion process takes a starting liquid material, such as a sterilant, e.g., about 35% hydrogen peroxide—[0024]).
Regarding claim 14, Novotny teaches the method according to claim 1 wherein, step e comprises aerating the chamber (vacuum chamber vented to atmospheric pressure to exhaust reagent out from the vacuum chamber with two or more additional vacuum cleaning stages to eliminate residual reagent from the product—[0047]; final stage of purification process includes venting residual gas out of the vacuum by venting the chamber to atmospheric pressure—[0069]; venting to atmospheric pressure and exhausting reagent to the atmosphere fairly constitutes an aeration step).
Regarding claim 15, Novotny teaches the method according to claim 1. Initially, it is noted that claim 15 recites that the microbial load of the plant matter is decreased at least 1000- fold after performing the method, which essentially recites an effect of the claimed method without clearly setting forth any further manipulative steps or further limitations on the method of claim 1 which yield the recited effect. Accordingly, since Novotny teaches a method indistinguishable from the method of claim 1, the method of Novotny is presumed to have the effect of decreasing a microbial load of the plant matter by at least 1000-fold. Furthermore, Novotny also explicitly indicates that a 1000-fold reduction in microbial load is achieved (in some embodiments, the sterilization comprises or results in at least a ….99.9% bioburden reduction—[0006], [0116], claim 13).
Regarding claim 16, Novotny teaches the method according to claim 1. Novotny further teaches the plant matter is heated in the chamber before step a (once the product 110 has been loaded in the vacuum chamber 102, a processing procedure is initiated—[0040]—an exemplary process logic for a purification process being as follows: heat the vacuum chamber 102 to a temperature from about 15°C to about 70°C….[afterwords] evacuate the vacuum chamber 102…and inject the reagent 150—[0042]; thus, by heating the chamber 102 with the product loaded therein, Novotny fairly teaches heating the plant matter in the chamber before evacuating the chamber; also see [0049] discussing heating vacuum chamber 102 to a temperature in a range of 20-55° to provide an environment in which the subsequently-introduced reagent can become evenly dispersed throughout the chamber 102).
Regarding claim 21, Novotny teaches the method according to claim 4. As discussed with respect to claim 4, the step b. of Novotny as indicated in annotated Fig. 7F above includes a venting to atmospheric pressure (the chamber pressure is then increased to a process high, forming a steep rise in the graph—[0109]; a first venting of the pressure chamber raises the pressure of the chamber to atmospheric pressure—[0118]; also see [0046] discussing varying the pressure to alter the state of the reagent), which implies that atmospheric air flows into chamber such that the plant matter is contacted with a gas comprising air at the higher pressure.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Novotny (US 2021/0052753 A1) in view of Burke et al. (US 2015/0305344 A1).
Regarding claim 6, Novotny teaches the method according to claim 5. As discussed with respect to claim 5, most embodiments of Novotny are directed toward a sterilant comprising a reactive oxygen reagent such as hydrogen peroxide (vaporized hydrogen peroxide—see [0027]-[0028], and [0042]), although Novotny does contemplate that the method can be adapted for different types of sterilant (depending on the reagent to be vaporized—[0042]; based on the type of liquid reagent being used—[0065]; note that [0024] discusses hydrogen peroxide as an exemplary sterilant, suggesting other sterilant may be suitable). Nonetheless, Novotny does not disclose that the sterilant is a chlorine agent selected from the group consisting of hypochlorite ion, hypochlorous acid, or chlorinated cyanurate.
However, in the analogous art of sterilization processes (title), Burke teaches a sterilization process for killing spores wherein an aqueous composition comprising hydrogen peroxide is formed into droplets, vaporized, and made to contact the spores (abstract, [0005], claim 1). Burke further teaches that the aqueous composition comprises an antimicrobial agent (claim 3) present at a concentration of 0.0001 to 7% by weight ([0010], claim 6), including embodiments wherein the antimicrobial agent is sodium dichloroisocyanurate ([0037], claim 18). Burke further indicates that the hydrogen peroxide and antimicrobial agent are understood to have a synergistic spore killing effect (with the present invention it is believed that the mechanism that is provided involves the peroxide, e.g., hydrogen peroxide, first piercing holes in multiple layers surrounding the central core of the spores, and then the antimicrobial agent advancing through the pierced holes and attacking the central core to kill the spores—[0032]). Therefore, it would be obvious to a person having ordinary skill in the art to modify the method of Novotny such that the liquid reagent (i.e., sterilant) of Novotny comprises an aqueous composition comprising hydrogen peroxide in combination with sodium dichloroisocyanurate at a concentration of 0.001-7% by weight, as seen in Burke, for the benefit of enhancing the spore killing effect of the applied sterilant (see Burke at [0032]).
It is noted that sodium dichloroisocyanurate (NaDCC) is a chlorinated cyanurate.
Regarding claim 7, Novotny in view of Burke teaches the method according to claim 6. As discussed with respect to claim 6 above, it would be obvious to modify Novotny in view of Burke such that an aqueous composition comprising hydrogen peroxide and 0.001-7% sodium dichloroisocyanurate (NaDCC) is used as the sterilant; i.e., Novotny in view of Burke teaches the chlorinated cyanurate is NaDCC.
Regarding claim 8, Novotny in view of Burke teaches the method according to claim 7. As discussed with respect to claims 6 and 7, Novotny in view of Burke teaches a sterilant comprising an aqueous composition including 0.001-7% NaDCC, which encompasses the claimed value of 2% NaDCC. Therefore, it would be obvious to a person having ordinary skill in the art to select the overlapping portion of the claimed value and the prior art range (see MPEP 2144.05(I.)), for the benefit of providing an effective amount of NaDCC to achieve an antimicrobial effect. Also see MPEP 2144.05(II.)(A.) regarding the obviousness of finding an optimum concentration value through routine optimization of the prior art conditions.
Claims 10, 12, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Novotny (US 2021/0052753 A1).
Regarding claim 10, Novotny teaches the method according to claim 4. Novotny further teaches that the plant is contacted by the injected primary sterilant at a lower pressure which is between 10 and 100 Torr (see Fig. 7F, the smaller peaks near the label “green” show the pressures at which the sterilant contacts the plant; the pressures are shown to be between 10 and 100 Torr on the logarithmic scale, being closer to 10; also see [0109] discussing distinct diffusion pressure ranges of 3-100 Torr, 50-200 Torr, and 250-600 Torr, corresponding approximately of ranges of 4-133 mbar, 67-267 mbar, and 333-800 mbar, respectively), a range of 10 to 100 Torr corresponding to a range of about 13 mbar to 133 mbar. Accordingly, it is evident that the lower pressure of Novotny (between 13 mbar and 133 mbar) overlaps with the claimed range of 30-100 mbar; therefore, it would be obvious to a person having ordinary skill in the art to perform he method of Novotny such that the lower pressure is within the overlapping portion of the claimed range and the range of Novotny for the benefit of driving the sterilant toward the load plant material at a desired moisture content (see [0068] discussing how diffusing a reagent gas at different pressures affects the moisture content of the gas).
Regarding claim 12, Novotny teaches the method according to claim 1. Novotny further teaches the plant matter is contacted with a primary sterilant at a lower pressure for a predetermined duration of time to achieve sterilization of the plant matter (abstract, [0006], [0009], [0068], [0116], claim 1; cycles of varying time/duration and pressures to saturate the product with the reagent 150—[0046]). Novotny teaches cycles of a purification process which comprise injection of a vaporized sterilant into a vacuum chamber containing plant matter ([0042]) and dwelling so that the vaporized sterilant penetrates into the plant matter ([0043]), wherein the cycle duration may have substantially any value within a broad set of disclosed ranges ([0041], [0044]).An exemplary cycle duration is 16 minutes to 42 minutes ([0041]), with a related embodiment suggesting a cycle duration of about 8 minutes to about 25 minutes ([0051]) with a dwell portion sufficiently long to allow a vapor to penetrate the plant matter being treated ([0058]). Also, the exemplary cycle report provided at paragraph [0114] of Novotny shows injection starting at a first time (2:47) and continuing until at least the start of a diffusion step (7:01), defining at least 4 minutes of dwell/contact time for the sterilant with the plant matter at a low pressure.
From the above, it is evident that Novotny fairly suggests dwell times wherein the primary sterilant contacts the plant matter for times which overlap with and/or are near the claimed range of between 3 and 15 minutes, and thus it would be obvious to a person having ordinary skill in the art to perform the method of Novotny with a dwell time within the claimed range for the benefit of providing sufficient time for the sterilant to penetrate into the plant matter (see [0043], [0058]).
Regarding claim 17, Novotny teaches the method according to claim 1.Novotny teaches an exemplary embodiment wherein a vaporizer is heated to a temperature of 110 °C, a vacuum chamber is heated to a temperature of 40 °C, and a plant product inside the chamber has a temperature of 20-30 °C ([0067]). Novotny also teaches that chamber walls of the vacuum chamber may be heated during the sterilization process ([0072]; one or more walls of the vacuum/process chamber are heated during one or more of the multiple steps—[0023]), with an exemplary embodiment indicating that such heating of the walls can achieve a product temperature of about 70 °C while the walls have a temperature of about 90 °C ([0024]) in order to drive vaporized sterilant toward the product ([0066]).
Although Novotny does not explicitly teach that the plant matter is heated to a temperature within the claimed range of between 35°C and 60°C (instead teaching an embodiment with a lightly lower product temperature of 20-30 °C—see [0067]—and an embodiment with a slightly higher product temperature of 70 °C —see [0024]), Novotny is clear in teaching embodiments wherein the plant matter is heated during the sterilization process (i.e., at least via heating the chamber walls—[0023], [0072]; also, the contact of the plant with the higher temperature sterilant would also be expected to at least partially heat the plant product), and Novotny further is clear in suggesting that the temperature of the process be optimized based on the reagent being used (the pressure and/or temperature can be adjusted to optimize the process based on the type of liquid reagent being used—[0065]), preferably so that the sterilant disperses throughout the vacuum chamber and is driven toward the product (heated chamber 102 provides an environment in which the introduced reagent 150 can become evenly dispersed throughout the chamber –[0049]; reagent 150 is vaporized and pulled into the vacuum chamber 102 wherein it migrates toward the lower-temperature surface of the product 110—[0066]; penetration of the vapor into the material can be caused by a temperature gradient—[0024]).
Therefore, it would be obvious to a person having ordinary skill in the art to modify the method of Novotny such that the plant matter product is heated to a temperature within the claimed range of 35-60°C during contact of the plant matter with sterilant by heating the chamber walls to a higher temperature, as seen in Novotny, for the benefit of creating an environment within the chamber which promotes the dispersion of the sterilant throughout the chamber and which directs the sterilant toward the surface of the plant product (see Novotny at [0024], [0065]-[0066]). Also see MPEP 2144.05(II.)(A.) regarding the obviousness of the routine optimization of prior art conditions.
Regarding claim 18, Novotny teaches the method according to claim 1. Novotny further teaches the plant matter is irradiated with UV light during the purification process (a purification process or step can, alternatively or in addition to the foregoing, include exposing the material to ultraviolet radiation to sterilize or de-contaminate at least a surface of the material—[0045]). Novotny is not clear in particularly indicating that the irradiation with UV light occurs while the plant matter is contacted with a sterilant. However, the purification process of Novotny has a finite number of steps, some of the steps including contacting the pant matter with a sterilant (see [0042]-[0043]), and Novotny indicates that a step of the purification can process can include UV radiation in addition to other actions ([0045]). Accordingly, Novotny fairly suggests an embodiment wherein the irradiation with UV light and contacting of the plant matter with sterilant occur simultaneously, such that it would be obvious to select such an embodiment when performing the method of Novotny for the benefit of enhancing the sterilization of the surfaces of the plant matter by irradiation with UV light (see Novotny at [0045]).
Regarding claim 19, Novotny teaches the method according to claim 1. As discussed with respect to claim 1 above, Fig. 7F of Novotny teaches that steps b and c are repeated at least once. Fig. 7F does not show that the steps b. and c. are repeated twice, three times, or four times. However, Novotny does indicate that a series of cycles can improve the diffusing of a sterilant (reagent) into the plant matter (product) ([0043]; one or more cycles are performed to saturate the product 110 with reagent—[0046]). Accordingly, Novotny fairly suggests repeating steps b. and c. for as many times as needed so as to improve the diffusion of the sterilant into the plant matter (see [0043], [0046]). Therefore, it would be obvious to a person having ordinary skill in the art to modify the method of Novotny such that steps b. and c. are repeated, e.g., three times, for the benefit of improving the diffusion of the sterilant into the plant matter.
Regarding claim 20, Novotny teaches the method according to claim 19. As discussed with respect to claim 19 above, it would be obvious to modify Novotny such that steps b. and c. are repeated three times (see rejection of claim 19 above).
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Novotny (US 2021/0052753 A1) in view of Shodder (US 2020/0101186 A1).
Regarding claim 11, Novotny teaches the method of claim 4. Novotny teaches that the higher pressure is atmospheric pressure (760 Torr; see Fig. 7F), i.e., 1,013 mbar. Thus, Novotny does not teach the higher pressure is between 100 and 700 mbar.
However, in the analogous art of sterilization methods (title), Shodder teaches a sterilization method (title) comprising steps of evacuating a chamber (302), injecting a vaporized chemical into the chamber (304), holding the injected vapor within the chamber (306), injecting gas into the sterilization to increase pressure (308), and holding at the higher pressure (310) ([0064]; see Fig. 3A below).
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The post-injection hold (306) ranges from 2 minutes to 20 minutes, especially between 10 and 15 minutes ([0070]). During the post-transition hold (310), a pressure between about 500 millibars and 1100 millibars is held, such as a pressure of about 700 millibars ([0071]), and the post-transition hold lasts between 5 and 20 minutes, such as between 10 and 15 minutes ([0072]). The steps (302, 304, 306, 308, 310) of the sterilization phase (300) may be repeated between 1 and 10 times ([0073]). The injection of the gas is described as serving to move sterilization chemical molecules off from the sterilization load ([0075]-[0077])
Therefore, it would be obvious to a person having ordinary skill in the art to modify the method of Novotny such that the after the sterilant is injected, a first pressure is held for a first duration, a gas is subsequently injected into the chamber to achieve a second pressure of about 700 millibars, and the second pressure is held for 10 to 15 minutes, as substantially seen in Shodder, for the benefit of removing sterilization chemical molecules from the sterilization load (see Shodder at [0075]-[0077]).
Said pressure of about 700 mbar falls within or overlaps with the claimed higher pressure range of between 100 and 700 mbar.
Regarding claim 13, Novotny teaches the method according to claim 1. Novotny does not particularly disclose that the plant matter is contacted with a gas or a secondary sterilant at a higher pressure for between 3 and 15 minutes.
However, as discussed with respect to claim 11 above, it would be obvious to modify the method of Novotny in view of Shodder to include a step of injecting a gas and holding for 10 to 15 minutes (see rejection of claim 11 above). Thus, Novotny in view of Shodder fairly teaches the plant matter is contacted with a gas or a secondary sterilant at a higher pressure for between 3 and 15 minutes.
Conclusion
Andersen et al. (US 2020/0296959 A1) teaches a method for decontaminating agricultural material such as hemp and marijuana by contacting the agricultural material with an ethylene oxide sterilant for a time and at a temperature sufficient to disinfect the agricultural material (abstract).
Zhang et al. (US 2020/0114029 A1) teaches a sterilization method which includes steps, in sequence, of driving a vacuum pump to depressurize a sterilization chamber ([0069]), a sterilant is sprayed into the chamber ([0076]) for a repeated number of times ([0077]-[0080]), a ventilation device introduces atmospheric air into the chamber until a predetermined pressure is achieved ([0081]), the chamber dwells at the predetermined pressure for a time (t3) ([0082]), and a similar cycle (second sterilization process 102) is repeated ([0084]-[0087]) (see Figs. 2-5). It is noted that Zhang supports the finding (most relevant with respect to claim 4 above) that a venting to atmospheric pressure, as discussed in Novotny, fairly implies introducing atmospheric air into the chamber (e.g., see Zhang at [0093]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADY C PILSBURY whose telephone number is (571)272-8054. The examiner can normally be reached M-Th 7:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL MARCHESCHI can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRADY C PILSBURY/Examiner, Art Unit 1799
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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