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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2025 September 10 has been entered.
Claims 1-3 and 9-28 are pending. Claims 10-20 have been withdrawn.
Claims 1-3, 9, and 21-28 are presently examined.
Election/Restrictions
Newly submitted claims 25-28 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons.
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-3, 9, and 23-24, drawn to a cannabis flower product, classified in A61K36/3482.
II. Claims 21-22, drawn to a cannabis flower product, classified in A61K36/3482.
III. Claims 25-28, drawn to a method of manufacturing a cannabis flower product, classified in A24B15/303.
Inventions I and II are directed to related products. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed overlap in scope and appear to be obvious variants. Inventions I and II are grouped together.
Inventions I and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the process II can make a product comprising THCa crystals having a diameter of greater than or equal to 100 microns. Moreover, product I is limited by structure that is positively recited and by structure that is implied by the recited process steps, so the product I can be made by a process that does not manufacture THCa crystals by centrifuging from trim and leaves and solvent-extracting from trim and leaves, absent evidence to the contrary. See MPEP 2113.
Inventions II and III are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case, the product II can be made by a process that does not comprise centrifuging or solvent-extracting.
Since applicant has received an action on the merits for the originally presented invention, Groups I and II have been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 25-28 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Interpretation
Claims 1 and 22 recite product-by-process limitations. See MPEP 2113: a product is limited by structure that is positively recited and by structure that is implied by the process steps, not by the process steps themselves.
Claim Objections
Claims 1, 21, and 23 are objected to because of the following informalities:
Claims 1 and 21: in the preamble, “a cannabis flower product having a crystal coating comprising” is suggested to be “a cannabis flower product having a crystal coating and comprising” to clearly show that the body of the claim is drawn to the cannabis flower product as a whole, not only to the crystal coating.
Claim 23: the term “the average crystal diameter” is suggested to be “the average diameter” to clearly point to the same term first recited in claim 1.
Appropriate correction is required.
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.
Claim 1-3, 9, and 23-24 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.
Claim 1: the claims recite a primary process comprising centrifugal separation to separate THCa crystals and a secondary process comprising solvent extraction to yield additional THCa crystals. Confusion arises as to whether (A) centrifuging yields a first batch of crystals and solvent-extracting yields a second batch of crystals additional to the first batch, or (B) the solvent-extracting augments the centrifuging to yield more crystals than a typical centrifuging. Interpretation (A) appears to be new matter, while interpretation (B) appears to be old matter consistent with the centrifuging and the solvent-extracting being simultaneous [applicant 44-46].
Claims 2-3, 9, and 23-24 are rejected by dependence on claim 1.
Claim 9: the claim depends on cancelled claim 8. The claim is interpreted as depending on claim 1 to make the claim examinable.
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.
Claims 1-3 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Thibodeau (US 20220007707 A1) in view of Walser (US 20190321425 A1) and Fisher (WO 2021248235 A1) and Boeckl (US 20170232210 A1) and Glas (US 20220168235 A1) as evidenced by “1.5 Gram THCa Diamonds” (hereinafter Bloomlite).
Claims 1-2 and 23-24: Thibodeau teaches a cannabis flower product ([92-93], mash compound) having a crystal coating (THCa in crystal form) comprising:
at least one batch of cannabis biomass (cannabis flower) including cannabis flowers and leaves [135];
THCa (THCa) crystals (THCa in crystal form);
the THCa crystals (THCa in crystal form) visibly coat the cannabis flowers (cannabis flower) to create the cannabis flower product to reflect incident light (all crystals reflect some amount of light) and thereby inhibit oxidation (the crystals cover the cannabis flower from oxygen to some extent), improve shelf life (the crystals cover the cannabis flower from oxygen to some extent), and provide a sparkling appearance of the cannabis flower product (THCa crystals reflect light);
wherein the cannabis flower product ([92-93], mash compound) has a total cannabinoid content that is about 20% of the cannabis flower product mass (fig. 4 and [126], 19.2% THC + 1.2% CBD = 20.4% cannabinoids; [4-5], terpenes are not cannabinoids).
Thibodeau does not explicitly teach that cannabis biomass includes trim, that the THCa crystals have a purity of at least 95% THCa derived from trim and leaves of the at least one batch of cannabis biomass;
the THCa crystals are manufactured using a primary and secondary process applied to the cannabis flowers and:
the primary process includes centrifugal separation to mechanically separate THCa crystals from the trim and leaves;
the secondary process including solvent extraction of the trim and leaves to yield THCa crystals from the trim and leaves;
the THCa crystals have an average diameter of less than 100 microns and comprise less than 10% of the total cannabinoid content,
or have an average diameter of between 20-70 microns and comprise less than 2% of the total cannabinoid content.
Walser teaches a cannabis biomass comprising various parts of the cannabis plant such as flower, leaves, and trim [83], such that the cannabis biomass approximates a whole cannabis extract to deliver different and advantageous compositions to a user [83].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to specify that Thibodeau’s cannabis biomass includes trim, because doing so would enable the cannabis biomass to approximate a whole cannabis extract to deliver different and advantageous compositions to a user.
Fisher teaches purifying THCa crystals to 99% THCa (abstract) by a primary process that includes centrifugal separation to mechanically separate THCa crystals from the trim and leaves ([43-45], centrifugal contacting) and by a second process that includes solvent extraction of the trim and leaves to yield tetrahydrocannabinolic acid crystals (washing with a C5 – C8 hydrocarbon solvent), such that the THCa crystals are largely free of impurities (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Thibodeau’s THCa crystals of generic purity, Fisher’s THCa crystals of 99% purity manufactured by centrifuging and solvent-extracting, because doing so would yield a purer product that is largely free of impurities.
Boeckl teaches a THCa powder [31] crushed to a diameter of at least 10 microns, exemplified as 20-40 microns [27-28], such that the THCa powder is suitable for delivery to a user [27-28].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to grind Thibodeau’s THCa crystals to between 20-40 microns as taught by Boeckl, because doing so is exemplified as making the THCa crystals suitable for delivery to the lungs or mouth of a user.
Glas teaches 0.1mg trichome crystal powder [61] added to a 50mg cannabis product [58], such that consuming the cannabis product facilitates restful sleep in a user [67].
Cannabis trichomes comprise the highest THCa concentrations of known materials to yield a fair analogy between THCa crystals and Glas’s trichome crystal powder (Bloomlite p. 2).
Applying Glas’s 0.1mg THCa crystal / 50mg cannabis product ratio to Thibodeau’s cannabis product that is about 20% cannabinoid (fig. 4) would yield (0.1mg THCa crystal / 50mg cannabis product) * (100% cannabis product / about 20% cannabinoid) = about 0.01mg THCa crystals / 1mg cannabinoid = about 1% THCa crystals relative to total cannabinoid content.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to dose Thibodeau’s THCa crystals in a mass ratio of 0.1mg THCa:50mg cannabis mash as taught by Glas, which in Thibodeau yields about 1% THCa crystals relative to total cannabinoid content, because doing so would facilitate restful sleep in a user.
The recited process steps of manufacturing THCa crystals by centrifuging THCa crystals from trim and leaves and solvent-extracting THCa crystals from trim and leaves do not appear to differentiate the THCa crystals over modified Thibodeau’s THCa crystals. Modified Thibodeau teaches the claimed structure that is positively recited and the structure that is implied by the process steps. See MPEP 2113.
Claim 3: modified Thibodeau teaches the cannabis flower product as set forth in claim 1, wherein the cannabis flower product has a total cannabinoid content of between 20-30% (fig. 4 and [126], 19.2% THC + 1.2% CBD = 20.4% cannabinoids; [4-5], terpenes are not cannabinoids).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Thibodeau (US 20220007707 A1) in view of Walser (US 20190321425 A1) and Fisher (WO 2021248235 A1) and Boeckl (US 20170232210 A1) and Glas (US 20220168235 A1) as evidenced by “1.5 Gram THCa Diamonds” (hereinafter Bloomlite) and applied to claim 1 in further view of Cranford (US 20170188623 A1).
Claim 9: modified Thibodeau teaches the cannabis flower product as set forth in claim 8.
Modified Thibodeau does not explicitly teach that the cannabis flower product is rolled into a cannabis cigarette.
Cranford teaches a cannabis flower product (fig. 2, #50) rolled into a cannabis cigarette (100), such that cannabinoids can be delivered in a controlled manner [10].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to roll Thibodeau’s cannabis flower product into a standardized cannabis cigarette as taught by Cranford, because doing so would enable cannabinoids to be delivered in a controlled manner.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Thibodeau (US 20220007707 A1) in view of Walser (US 20190321425 A1) and Fisher (WO 2021248235 A1) and Glas (US 20220168235 A1) as evidenced by “1.5 Gram THCa Diamonds” (hereinafter Bloomlite).
Claim 21: Thibodeau teaches a cannabis flower product ([92-93], mash compound) having a crystal coating (THCA in crystal form) comprising:
at least one batch of cannabis biomass (cannabis flower) including cannabis flowers and leaves [135];
THCa (THCa) crystals (THCa in crystal form);
the THCa crystals (THCa in crystal form) visibly coat the cannabis flowers (cannabis flower) from the at least one batch of cannabis biomass to create the cannabis flower product (mash compound);
and wherein the cannabis flower product (mash compound) has a total cannabinoid content (fig. 4 and [126], 19.2% THC + 1.2% CBD = 20.4% cannabinoids; [4-5], terpenes are not cannabinoids).
Thibodeau does not explicitly teach that cannabis biomass includes trim, that the THCa crystals have a purity of at least 95% THCa derived from trim and leaves of the at least one batch of cannabis biomass;
the THCa crystals comprise less than 10% of the total cannabinoid content.
Walser teaches a cannabis biomass comprising various parts of the cannabis plant such as flower, leaves, and trim [83], such that the cannabis biomass approximates a whole cannabis extract to deliver different and advantageous compositions to a user [83].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to specify that Thibodeau’s cannabis biomass includes trim, because doing so would enable the cannabis biomass to approximate a whole cannabis extract to deliver different and advantageous compositions to a user.
Fisher teaches purifying THCa crystals to 99% THCa (abstract) by a primary process that includes centrifugal separation to mechanically separate THCa crystals from the trim and leaves ([43-45], centrifugal contacting) and by a second process that includes solvent extraction of the trim and leaves to yield tetrahydrocannabinolic acid crystals (washing with a C5 – C8 hydrocarbon solvent), such that the THCa crystals are largely free of impurities (abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use, as Thibodeau’s THCa crystals of generic purity, Fisher’s THCa crystals of 99% purity manufactured by centrifuging and solvent-extracting, because doing so would yield a purer product that is largely free of impurities.
Glas teaches 0.1mg trichome crystal powder [61] added to a 50mg cannabis product [58], such that consuming the cannabis product facilitates restful sleep in a user [67].
Cannabis trichomes comprise the highest THCa concentrations of known materials to yield a fair analogy between THCa crystals and Glas’s trichome crystal powder (Bloomlite p. 2).
Applying Glas’s 0.1mg THCa crystal / 50mg cannabis product ratio to Thibodeau’s cannabis product that is about 20% cannabinoid (fig. 4) would yield (0.1mg THCa crystal / 50mg cannabis product) * (100% cannabis product / about 20% cannabinoid) = about 0.01mg THCa crystals / 1mg cannabinoid = about 1% THCa crystals relative to total cannabinoid content.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to dose Thibodeau’s THCa crystals in a mass ratio of 0.1mg THCa:50mg cannabis mash as taught by Glas, which in Thibodeau yields about 1% THCa crystals relative to total cannabinoid content, because doing so would facilitate restful sleep in a user.
Claim 22: modified Thibodeau teaches the cannabis flower product of claim 21.
Modified Thibodeau does not explicitly teach that the THCa crystals and the cannabis flowers are derived from a single batch of cannabis biomass.
The recited process step of deriving THCa crystals and cannabis flowers from a single batch of cannabis biomass does not appear to differentiate the THCa crystals and the cannabis flowers over modified Thibodeau’s THCa crystals and cannabis flowers. Modified Thibodeau teaches the claimed structure that is positively recited and the structure that is implied by the process steps. See MPEP 2113.
Response to Arguments
Applicant’s arguments of 2025 September 10 have been carefully considered but are not persuasive.
Applicant argues (p. 2-3, “Response to Rejection under 35 U.S.C. § 101”) that the amended claims overcome 35 U.S.C. § 101. However, the examiner’s final rejection of 2025 July 11 rejected no claims over 35 U.S.C. § 101. Applicant’s arguments are unclear.
Applicant argues (p. 4) that various references of record “focus” and “emphasize” different aspects of the claimed invention. However, that a given reference focuses on a first aspect of an invention but is silent on a second aspect of the invention does not constitute nonobviousness. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Applicant argues (p. 5, [2-3]) that the art of record do not teach deriving THCa crystals and cannabis flower from the same batch of cannabis biomass. However, the art of record do teach THCa crystals and cannabis flower, and the recited process step of deriving from the same batch does not appear to differentiate over the art. See MPEP 2113.
Applicant argues (p. 5, [4-5]) for method claims 25-28 that were withdrawn by original presentation. Furthermore, applicant argues limitations which are not claimed, e.g., halving processing time, increasing yield, and avoiding agitation risks. However, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
If applicant intends to argue improved properties, “the fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.” Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). See MPEP 2145(II).
Applicant argues (p. 6, [1-2]) that Thibodeau, Boeckl, and Cranford are different. However, combined prior art need not be analogous to each other and need only be analogous to the instant invention. See MPEP 2141.01(a).
Thibodeau is in the same field of endeavor as (cannabis products) and reasonably pertinent to (making cannabis products) the instant invention.
Boeckl is reasonably pertinent to (grinding THCa powders) the instant invention.
Cranford is in the same field of endeavor as (cannabis products) and reasonably pertinent to (making cannabis products) the instant invention.
Thibodeau ‘742 was not cited by the examiner in the final rejection of 2025 July 11 and does not pertain to the amended claims of 2025 September 10.
Applicant argues (p. 6, “Response to Rejection under 35 U.S.C. § 112”) that the amended claims overcome 35 U.S.C. § 112. However, the examiner’s final rejection of 2025 July 11 rejected no claims over 35 U.S.C. § 112. Applicant’s arguments are unclear.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tobey C. Le whose telephone number is (703)756-5516. The examiner can normally be reached Mon-Thu 8:30-18:30 ET.
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/TOBEY C LE/Examiner, Art Unit 1747
/KATHERINE A WILL/Primary Examiner, Art Unit 1747