DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 20-24 and 27 in the reply filed on 8/18/26 is acknowledged.
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.
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 20-24 and 27 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.
In Claims 20, 21, 23, and 24, the term “not negligible” is a relative term which renders the claim indefinite. 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. Applicant’s specification states the following: “the term "not negligible" in combination with the concept of the acid form content of the one or more cannabinoids refers to a content which is sufficient to provide the herein described desired physical properties of the hashish product.” ([0048]). However, this definition of the term “not negligible” 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 content of the one or more cannabinoids in acid form. Thus, Claims 20, 21, 23, and 24 are rejected for being indefinite and Claims 22 and 27 are rejected for their dependency on the indefinite claims.
Regarding Claims 23 and 24, 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, Claim 23 recites the broad recitation "the one or more cannabinoid(s) is of no less than 1 wt.% and the claim also recites "preferably of no less than 3 wt.%, even more preferably of no less than 5 wt.%" which is the narrower statement of the range/limitation. Claim 24 recites the broad recitation "one or more cannabinoid(s) is of up to about 30 wt.% and the claim also recites "preferably up to about 25 wt.%, more preferably up to about 20 wt.%" which is the narrower statement of the range/limitation. The claims 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. Thus, Claims 23 and 24 are rejected for being indefinite.
Claim Rejections - 35 USC § 102
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 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.
Claim 20 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pal (US 20200261824 A1, cited in IDS dated 11/30/23).
Regarding Claim 20, Pal discloses a hashish product (The plant matter rich in trichomes is compressed into a cake. [0048]) comprising
a cohesive mass of isolated cannabis trichomes (The compressed cake may comprise isolated cannabis trichomes. [0005]-[0008]) and
a not negligible content in acid form of one or more cannabinoid(s) (The isolated trichomes naturally comprise THCa, which may be subjected to a decarboxylation step before the powder is compressed into the cake form. [0025], [0039]-[0041], [0048]) and
made by the process according to claim 1 (The isolated trichomes may be subjected to heat in order to undergo a decarboxylation step before the powder is compressed into the cake form, thus converting some of the natural THCa into THC prior to being compressed. [0039]-[0041], [0048]. The limitation is a product-by-process limitation. Patentability of a product is based on the product itself and does not depend on the method of production. If the claimed product is the same as or obvious from the prior art, the claim is unpatentable even though the prior product may be made by a different process. See MPEP 2113(I). Here, absent evidence to the contrary, Pal discloses a compressed hashish product comprising: isolated cannabis trichomes, THC, and THCa, and thus meets the claim).
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.
Claims 21, 22, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Pal (US 20200261824 A1, cited in IDS dated 11/30/23).
Regarding Claim 21, Pal discloses a hashish product (The plant matter rich in trichomes is compressed into a cake. [0048]) comprising
a cohesive mass of isolated cannabis trichomes (The compressed cake may comprise isolated cannabis trichomes. [0005]-[0008]) and
a not negligible content in acid form of one or more cannabinoid(s) (The isolated trichomes naturally comprise THCa, which may be subjected to a decarboxylation step before the powder is compressed into the cake form. [0025], [0039]-[0041], [0048]).
Pal does not explicitly disclose the stiffness, hardness, and/or toughness of the hashish product as determined in a three-point bending test. However, given that the stiffness, hardness, and/or toughness of a hashish product is dependent on the composition of the pressed product, specifically the composition of trichomes and THCa to THC, it follows that Pal, having an overlapping composition as the claimed hashish product, would reasonably have one or more overlapping properties with the following properties as determined in a three-point bending test: a) a higher limit of stiffness of about 3200 g/mm, b) a higher limit of hardness of about 2500 g, and c) a higher limit of toughness of about 8000 g*mm, similarly as claimed absent evidence to the contrary. See MPEP 2112(III).
Furthermore, given that the pressure applied during the compression of the hashish product directly effects the stiffness, hardness, and/or toughness of the final hashish product, a person having ordinary skill in the art would be motivated to perform routine optimization. Moreover, a person having ordinary skill in the art would have a reasonable expectation of success through experimentation of determining a preferred user range of stiffness, hardness, and/or toughness through modification of the variables discussed in Pal, such as the applied pressure and filter press pore size ([0047]-[0050]). Therefore, it follows that a person having ordinary skill in the art, through routine optimization of applied pressure and filter press pore size as disclosed in Pal, would arrive at the stiffness, hardness, and/or toughness of the hashish product, similarly as claimed absent evidence to the contrary. See MPEP 2144.05(II).
Regarding Claim 22, Pal discloses a hashish product comprising wherein the acid form of the one or more cannabinoid(s) comprises tetrahydrocannabinolic acid (THC-A), cannabidiolic acid (CBD-A), or both THC-A and CBD-A (The isolated trichomes naturally comprise THCa but may undergo a decarboxylation step before the powder is compressed into the cake form. [0025], [0039]-[0041], [0048]).
Regarding Claim 27, Pal discloses a hashish product comprising wherein the isolated cannabis trichomes are kief (Cannabis plant matter rich in trichomes is dried using various drying techniques resulting in a fine, dry powder rich in trichomes (kief). [0039]).
Claims 23 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Pal as applied to Claim 21 above, and/or in the alternative in further in view of Kotra (US 20180000857 A1)
Regarding Claim 23, Pal discloses wherein the composition comprises THCa ([0025], [0039]-[0041], [0048]), but does not explicitly disclose wherein the content in the acid form of the one or more cannabinoid(s) is of no less than 1 wt.%. However, given that the content in the acid form of the one or more cannabinoid(s) directly effects the psychoactive quality of the hashish product ([0041]), a person having ordinary skill in the art would be motivated to perform routine optimization. Moreover, a person having ordinary skill in the art would have a reasonable expectation of success through experimentation of determining a preferred user range of THCa to THC in a cannabinoid blend. Therefore, it follows that a person having ordinary skill in the art, through routine optimization of the psychoactive quality of the hashish product disclosed in Pal, would arrive at the content in the acid form of the one or more cannabinoid(s) similarly as claimed, absent evidence to the contrary. See MPEP 2144.05(II).
Furthermore, Korta teaches a decarboxylated cannabis product ([0002]) comprising a composition comprising THCa wherein the composition of THCa is no less than 1wt% (cannabinoids in trichomes may be 90-99% decarboxylated, thus resulting in the cannabinoid in the acid form (THCa) ranging from 1-10%. [0004], [0009], [0015]). Therefore, before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the THCa composition of Pal with a composition of THCa of no less than 1wt% as taught by Korta because Pal and Korta are both directed to cannabis compositions comprising a blend of THC and THCa, Korta teaches a cannabis composition wherein the composition of THCa is no less than 1wt%, and this merely involves applying a known ratio/blend of a component to a similar product to yield predictable results.
Regarding Claim 24, Kotra further discloses wherein the not negligible content in the acid form of the one or more cannabinoid(s) is of up to about 30 wt.% (cannabinoids in trichomes may be 90-99% decarboxylated, thus resulting in the cannabinoid in the acid form ranging from 1-10%. [0004], [0009], [0015]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jeffrey Buckman whose telephone number is (571)270-0888. The examiner can normally be reached Monday-Friday 9:00-4:00.
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/JEFFREY A. BUCKMAN/Examiner, Art Unit 1755
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755
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