CTNF 18/290,206 CTNF 99480 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Status of the Claims Claims 1-17, 19, 21 and 24 are pending and are subject to this Office Action. This is the first Office Action on the merits of the claims. Claim Rejections - 35 USC § 112 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. Claims 4-7, 10-12, 14-15 and 17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Regarding claims 4-7, 11-12 and 14-15, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claims 4-7, 10-12 and 14-15 recite a broad recitation (e.g., as in claim 4, “a temperature range of from about 70C to about 130C”), and the claim also recites a preferable which is the narrower statement of the range/limitation (e.g., as in claim 4, “preferably from about 80C to about 120C, more preferably about 120C”). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Regarding claim 10, the claim recites the term “the hashish product comprises a not negligible content in acid form of one or more cannabinoids”. The term “not negligible” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paragraph [0128] of the specification provides an example in which “not negligible” is “no less than 1 wt.%”. However, this is not a definition of the term, and the metes and bounds of the claim are unclear. For examination purposes the limitation is interpreted to read “the hashish product comprises an acid form of one or more cannabinoids”. Regarding claim 17, the claim recites the limitation “cutting the hashish product according to a pre-established cutting operational parameter.” It is unclear as to what comprises a “predetermined operational parameter”. For example, such a predetermined cutting parameter may be a length, width or shape of a cut, a type of cutting implement used, a pattern cut into the hashish, or any other cutting parameter. Paragraphs [0032] and [0025] of the specification describes a cutting pattern, but not a cutting operational parameter. Thus, the claim is indefinite. For examination purposes, the claim limitation will be read as “cutting the hashish product”. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-21-aia AIA Claim s 1-2, 4-5, 8-9 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Carnahan (US 20200199091 A1) in view of Pal et al. (US 20200261824 A1) . Regarding claim 1, Carnahan teaches a process of making a hashish product, comprising: providing cannabis trichomes ([0020], [0058]; provided to hopper 20; [0068]); mixing the cannabis trichomes (via rotation in auger 30; [0068]) under conditions sufficient to obtain a resinous mixture (paste; [0064]); and retrieving at least a portion of the resinous mixture through an extrusion die (extruder press head 60; [0068]) to obtain the hashish product comprising a cohesive mass of the cannabis trichomes. Carnahan does not explicitly teach that the cannabis trichomes are isolated cannabis trichomes pre-treated to comprise a cannabis oil layer on at least a portion of a surface thereof. Pal, directed to a method for providing isolated trichomes prior to further processing ([0005]), teaches that isolating the trichomes improves the quality of the final cannabis product ([0005]). Pal further teaches that the isolated trichomes may be pre-heated to decarboxylate the cannabinoids to produce psychoactive compounds ([0041]; [0051]). Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carnahan by using isolated, pre-treated trichomes as taught by Pal because Carnahan is directed to a method comprising producing trichomes and Pal is directed to producing trichomes, Pal teaches that producing isolated, decarboxylated trichomes is known to improve final product quality and increase psychoactive compounds, and this involves applying a known teaching to a similar process to yield predictable results. The Examiner notes that, while Pal does not explicitly disclose that the pre-treated trichomes comprise a cannabis oil layer on at least a portion of a surface thereof, the pre-treating process taught by the prior art is equivalent to the process as claimed and disclosed by the Applicant and therefore one of ordinary skill would reasonably expected that the pre-treating taught by Pal would result in a similar cannabis oil layer as claimed, absent evidence to the contrary. Regarding claim 2, Pal teaches that step a) comprises pre-heating the isolated cannabis trichomes under conditions to obtain at least partial decarboxylation of one or more cannabinoid(s) of the isolated cannabis trichomes ([0041], [0051]). Regarding claim 4, Pal teaches that the pre-heating is performed at a temperature of from about 70C to about 130C (Pal [0051] teaches heating at a temperature of 115C-120C) Regarding claim 5, Pal teaches that the pre-heating is performed for a duration of from about 10 minutes to about 80 minutes (Pal claim 14 teaches 30 minutes). Regarding claim 8, modified Carnahan does not explicitly teach that the pre- heating step is performed on a trichome-containing layer of at least 5 mm. However, it would be obvious to one having ordinary skill in the art that trichomes to be pre-heated would necessarily comprise a layer of greater than 0mm. Further, one having ordinary skill in the art would recognize that the thickness of the trichomes may be optimized so as to reduce the drying time while also minimizing damage to the trichomes (that may occur if a layer is too thin). Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to optimize the thickness of the trichomes to be pre-heated, one with ordinary skill in the art would recognize that this is a result effective variable and be motivated to optimize this variable to optimize drying time, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II). Regarding claim 9, Carnahan does not explicitly teach that the trichome-containing layer is no more than 10 mm. However, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to optimize the thickness of the trichomes to be pre-heated, one with ordinary skill in the art would recognize that this is a result effective variable and be motivated to optimize this variable to optimize drying time, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II). Regarding claim 13, Pal teaches that the acid form of the one or more cannabinoid(s) of the hashish product comprises tetrahydrocannabinolic acid (THC- A) ([0041]). Regarding claim 17, Carnahan does not explicitly teach that het process further comprises cutting the hashish product according to a pre-established cutting operational parameter. Carnahan teaches that the extruded material ([0030]) may be edible/consumable material ([0016], [0021], [0040]). Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carnahan by cutting the extruded material into a desired size because one having ordinary skill in the art would recognize that cutting would be necessary to package and/or use the extruded material, one having ordinary skill would further recognize that cutting after extrusion is known in the art, and this involves applying a known teaching to the process to yield predictable results. Regarding claim 19, Pal teaches that the process further comprises incorporating one or more cannabinoids (Pal [0006] teaches that isolated trichomes may be selected to comprise high content of cannabidiol, tetrahydrocannabinol or other cannabinoids) . 07-22-aia AIA Claim s 3, 6-7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Carnahan in view of Pal as applied to claim 1 above, and further in view of Luna Technologies (Decarboxylation: What is it and why is it Important <URL: https://lunatechequipment.com/blogs/blog/decarboxylation-what-is-it-and-why-is-it-important>) . Regarding claim 3, Pal teaches that step a) comprises i) isolating cannabis trichomes to obtain isolated cannabis trichomes ([0001]) and ii) pre-heating cannabis under conditions to obtain at least partial decarboxylation of one or more cannabinoid(s) of the cannabis ([0041], [0051]). Pal does not teach that the cannabis is pre-heated prior to trichome isolation. Luna technologies, directed to pre-heating/decarboxylating cannabis (page 1), teaches that trichomes may be pre-heated prior to trichome isolation to obtain the same decarboxylation of cannabinoids in the trichomes (page 1). Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carnahan by pre-heating the trichomes prior to isolation as taught by Luna Technologies because both modified Carnahan and Luna Technologies are directed to pre-treating trichomes to obtain decarboxylated cannabinoids, Luna Technologies teaches that the pre-heating process may alternatively be performed prior to trichome isolation, and this involves substituting one alternative pre-heating process for another to yield predictable results. Regarding claim 6, modified Carnahan does not specify that the pre-heating is performed to obtain a decarboxylation level of the one or more cannabinoid(s) of from about 30% to about 100%. Luna Technologies, directed to pre-heating/decarboxylating cannabis (page 1), teaches that decarboxylation can occur at varying rates, such that products may comprise both the acidic and the decarboxylated cannabinoid (page 3). One having ordinary skill in the art would recognize that the amount of psychoactive compound in the product may therefore be controlled or optimized. Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to optimize the decarboxylation of cannabinoids to obtain a desired amount, because Luna Technologies teaches that the decarboxylation level of cannabinoids is a result effective variable, one with ordinary skill in the art would be motivated to optimize this variable in order to obtain the desired amount of psychoactive compound, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II). Regarding claim 7, modified Carnahan does not specify that the pre-heating is performed to obtain a ratio of a decarboxylated to acid form content of the one or more cannabinoid(s), by weight, of from about 100:1 to about 1:100. Luna Technologies, directed to pre-heating/decarboxylating cannabis (page 1), teaches that decarboxylation can occur at varying rates, such that products may comprise both the acidic and the decarboxylated cannabinoid (page 3). One having ordinary skill in the art would recognize that the ratio of a decarboxylated to acid form in the product may therefore be controlled or optimized. Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to optimize the decarboxylation of cannabinoids to obtain a desired amount, because Luna Technologies teaches that the decarboxylation level of cannabinoids is a result effective variable, one with ordinary skill in the art would be motivated to optimize this variable in order to obtain the desired amount of psychoactive compound, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II). Regarding claim 10, modified Carnahan does not explicitly teach that the hashish product comprises a not negligible content in acid form of one or more cannabinoid(s). Luna Technologies, directed to pre-heating/decarboxylating cannabis (page 1), teaches that decarboxylation can occur at varying rates, such that products may comprise both the acidic and the decarboxylated cannabinoid (page 3). One having ordinary skill in the art would recognize that the amount of psychoactive compound in the product may therefore be controlled or optimized. Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to optimize the decarboxylation of cannabinoids to obtain a desired amount, because Luna Technologies teaches that the decarboxylation level of cannabinoids is a result effective variable, one with ordinary skill in the art would be motivated to optimize this variable in order to obtain the desired amount of psychoactive compound, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II). Upon adjusting the level of decarboxylation, one would directly be adjusting the number of acidic cannabinoids. Thus, a hashish product that comprises a not negligible content in acid form would similarly be obvious to one having ordinary skill. Regarding claim 11, it would be obvious for one having ordinary skill in the art to optimize the decarboxylation of cannabinoids to obtain a desired amount, because Luna Technologies teaches that the decarboxylation level of cannabinoids is a result effective variable (page 3), one with ordinary skill in the art would be motivated to optimize this variable in order to obtain the desired amount of psychoactive compound, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II). Upon adjusting the level of decarboxylation, one would directly be adjusting the number of acidic cannabinoids. Thus, a hashish product that comprises an acid form of one or more cannabinoids of no less than 1 wt. % would similarly be obvious to one having ordinary skill. Regarding claim 12, it would be obvious for one having ordinary skill in the art to optimize the decarboxylation of cannabinoids to obtain a desired amount, because Luna Technologies teaches that the decarboxylation level of cannabinoids is a result effective variable (page 3), one with ordinary skill in the art would be motivated to optimize this variable in order to obtain the desired amount of psychoactive compound, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II). Upon adjusting the level of decarboxylation, one would directly be adjusting the number of acidic cannabinoids. Thus, a hashish product that comprises an acid form of one or more cannabinoids of up to about 30 wt. % would similarly be obvious to one having ordinary skill. Regarding claim 14, modified Carnahan does not specify that the pre-heating is performed to obtain a decarboxylation level of the one or more cannabinoid(s) of from about 50% to about 100%. Luna Technologies, directed to pre-heating/decarboxylating cannabis (page 1), teaches that decarboxylation can occur at varying rates, such that products may comprise both the acidic and the decarboxylated cannabinoid (page 3). One having ordinary skill in the art would recognize that the amount of psychoactive compound in the product may therefore be controlled or optimized. Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to optimize the decarboxylation of cannabinoids to obtain a desired amount, because Luna Technologies teaches that the decarboxylation level of cannabinoids is a result effective variable, one with ordinary skill in the art would be motivated to optimize this variable in order to obtain the desired amount of psychoactive compound, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II) . 07-22-aia AIA Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Carnahan in view of Pal as applied to claim 1 above, and further in view of Orbetron (The Science of Material Flow: Overcoming Challenges in Bulk Feeding <URL: https://orbetronextrusion.com/the-science-of-material-flow-overcoming-challenges-in-bulk-feeding/>) . Regarding claim 15, Carnahan does not explicitly teach that the process further comprises incorporating water to the pre-treated isolated cannabis trichomes prior to step b). Orbetron, directed to material flow, teaches that flowability and moisture content are important factors when feeding materials to an extruder to prevent clogging (page 2). Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to optimize the feed conditions by adding and optimizing a water content, because Orbetron teaches that moisture content is a result effective variable, one with ordinary skill in the art would be motivated to optimize this variable to achieve successful extrusion and because having ordinary skill in the art would recognize that it would be important to find a moisture content that enabled flow while still maintaining an extruded shape, and because it has been held that, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller , 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP § 2144.05 (II) . 07-22-aia AIA Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Carnahan in view of Pal as applied to claim 1 above, and further in view of RapidDirect (What is Plastic Extrusion: A Definitive Process Guide <URL: https://www.rapiddirect.com/blog/plastic-extrusion-process/>) . Regarding claim 16, Carnahan does not explicitly teach that the extrusion die is a first extrusion die; and the process comprises passing the resinous mixture through a second extrusion die smaller than the first extrusion die to obtain the hashish product comprising the cohesive mass of the isolated cannabis trichomes. RapidDirect, directed to extrusion processes, teaches that a first extrusion die portion may be followed by a second extrusion die portion smaller than the first extrusion die (see Annotated Fig. 1). PNG media_image1.png 359 566 media_image1.png Greyscale Annotated Fig. 1 (Annotated from RapidDirect page 2) Therefore, before the effective filing date of the claimed invention, it would be obvious for one having ordinary skill in the art to modify Carnahan by using an extrusion die with a first portion and a smaller second portion as taught by RapidDirect because both Carnahan and RapidDirect are directed to extrusion processes, Carnahan is silent to the extrusion die design and one with ordinary skill would recognize that die design has a significant effect on extrusion flow profile and would be motivated to look to prior art for a known and suitable die design, and this involves applying a known teaching to a similar product to yield predictable results . 07-21-aia AIA Claim s 21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Carnahan in view of Pal as applied to claims 1 and 19 above, as evidenced by Bjorncrantz (US 20150105455 A1) . Regarding claim 21, modified Carnahan teaches further incorporating one or more cannabinoids (Pal [0006] teaches that isolated trichomes may be selected to comprise high content of cannabidiol, tetrahydrocannabinol or other cannabinoids). Bjorncrantz, directed to cannabis extracts ([0002]), teaches that trichomes obtained from a cannabis plant may be considered crude cannabis extract ([0026]). Therefore, one having ordinary skill in the art would understand that modified Carnahan implicitly teaches incorporating a crude cannabis extract by incorporating various trichomes. Regarding claim 24, modified Carnahan teaches further incorporating one or more cannabinoids (Pal [0006] teaches that isolated trichomes may be selected to comprise high content of cannabidiol, tetrahydrocannabinol or other cannabinoids). Bjorncrantz, directed to cannabis extracts ([0002]), teaches that trichomes obtained from a cannabis plant may be considered crude cannabis extract ([0026]). Therefore, one having ordinary skill in the art would understand that modified Carnahan implicitly teaches incorporating a crude cannabis extract by incorporating various trichomes. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Charlotte Davison whose telephone number is (703)756-5484. The examiner can normally be reached M-F 8:00AM-5:00PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Philip Louie can be reached at 571-270-1241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /C.D./Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755 Application/Control Number: 18/290,206 Page 2 Art Unit: 1755 Application/Control Number: 18/290,206 Page 3 Art Unit: 1755 Application/Control Number: 18/290,206 Page 4 Art Unit: 1755 Application/Control Number: 18/290,206 Page 5 Art Unit: 1755 Application/Control Number: 18/290,206 Page 6 Art Unit: 1755 Application/Control Number: 18/290,206 Page 7 Art Unit: 1755 Application/Control Number: 18/290,206 Page 8 Art Unit: 1755 Application/Control Number: 18/290,206 Page 9 Art Unit: 1755 Application/Control Number: 18/290,206 Page 10 Art Unit: 1755 Application/Control Number: 18/290,206 Page 11 Art Unit: 1755 Application/Control Number: 18/290,206 Page 12 Art Unit: 1755 Application/Control Number: 18/290,206 Page 13 Art Unit: 1755