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 . Claims 1-22 filed October 04, 2023 are currently pending.
Priority
Acknowledgement is made of Applicant’s effective filing date of 10/04/2023.
Claim Objections
Claim 7 is objected to because of the following informalities: claim 7 recites the phrase “wherein the at beta caryophyllene is between 0.1% and 3% of the composition by mass”. Appropriate removal of the phrase “at from between the and beta caryophyllene is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-4, 6, 8-11, 13-14, 16-18 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Claim 1 is directed to a composition comprising a natural product containing at least a cannabinoid and at least a terpene. Claims 2 and 4 are further narrowed to a composition comprising cannabidiol (CBD), cannabinol (CBN), cannabichromene (CBC) and cannabigerol (CBG), while claims 3 and 6 further embrace the composition of claim 1 to further contain the terpenes beta-caryophyllene and myrcene. Claim 11 is directed to a composition comprising cannabidiol (CBD), cannabinol (CBN), cannabichromene (CBC) and cannabigerol (CBG), while claims 13-14 embrace the composition of claim 11 further containing the terpenes beta-caryophyllene and myrcene. The claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims embrace a natural product, such as cannabis sativa as shown in Adair (WO2022/232574 published 11/03/2022) below. See the prior art rejections below.
According to Memorandum entitled, “Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products,” published online on March 4, 2014 (hereinafter "Guidance”). The Guidance establishes a three step inquiry to determine whether the claim is drawn to patent-eligible subject matter and should be rejected under 35 USC §101 as not being drawn to patent-eligible subject matter. The first inquiry is whether the claimed invention is directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter.
The second inquiry is whether the claim recites or involves one or more judicial exceptions. As described in MPEP § 2106, judicial exceptions includes abstract ideas, laws of nature/natural principles, natural phenomena, and natural products wherein these judicial exceptions reflect the judicial view that these fundamental tools of scientific and technological work are not patentable.
The third inquiry asks whether the claim as a whole recites something significantly different than the judicial exception(s). If the claims recites or involves a judicial exception such as a law of nature/natural principle or natural phenomenon, and/or something that appears to be a natural product, then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself. The Guidance notes that a significant difference can be shown in multiple ways, such as: (1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrates that the claimed subject matter is markedly different from what exists in nature. Moreover, the Guidance provides factors in aiding in the determination of whether claimed subject matter is markedly different from what exists in nature wherein the totality of the relevant factors weigh toward eligibility or ineligibility. It is noted that not all factors may be relevant for a particular invention.
Factors that weigh in favor of eligibility (i.e., claimed subject matter is significantly different): a) Claim is a product claim reciting something that initially appears to be a natural product, but after analysis is determined to be non-naturally occurring and markedly different in structure from naturally occurring products; b) Claim recites elements/steps in addition to the judicial exception(s) that impose meaningful limits on claim scope, i.e., the elements/steps narrow the scope of the claim so that others are not substantially foreclosed from using the judicial exception(s); c) Claim recites elements/steps in addition to the judicial exception(s) that relate to the judicial exception in a significant way, i.e., the elements/steps are more than nominally, insignificantly, or tangentially related to the judicial exception(s); d) Claim recites elements/steps in addition to the judicial exception(s) that do more than describe the judicial exception(s) with general instructions to apply or use the judicial exception(s); e) Claim recites elements/steps in addition to the judicial exception(s) that include a particular machine or transformation of a particular article, where the particular machine/transformation implements one or more judicial exception(s) or integrates the judicial exception(s) into a particular practical application and f) Claim recites one or more elements/steps in addition to the judicial exception(s) that add a feature that is more than well-understood, purely conventional or routine in the relevant field.
Factors that weigh against eligibility include the following (i.e., claimed subject matter is NOT significantly different): g) Claim is a product claim reciting something that appears to be a natural product that is not markedly different in structure from naturally occurring products; h) Claim recites elements/steps in addition to the judicial exception(s) at a high level of generality such that substantially all practical applications of the judicial exception(s) are covered; i) Claim recites elements/steps in addition to the judicial exception(s) that must be used/taken by others to apply the judicial exception(s); j) Claim recites elements/steps in addition to the judicial exception(s) that are well-understood, purely conventional or routine in the relevant field; k) Claim recites elements/steps in addition to the judicial exception(s) that are insignificant extra-solution activity, e.g., are merely appended to the judicial exception(s) and l) Claim recites elements/steps in addition to the judicial exception(s) that amount to nothing more than a mere field of use.
In the instant case, the claims embrace a natural product that is not significantly different from the judicial exception itself. As shown in Tables 2 and 4 of Adair, extraction of a cannabis sativa plant yields a composition containing cannabidiol, cannabinol, cannabichromene, cannabigerol and the terpenes beta-caryophyllene and myrcene ([0010], [0049]-[0057], [0077]). Accordingly, a composition containing cannabidiol, cannabinol, cannabigerol, cannabichromene and the terpenes beta-caryophyllene and myrcene as found in claims 1-4, 6, 8-11, 13-14, 16-18 reads on the naturally occurring product of a cannabis sativa plant found in Adair. As such, the pending claimed subject matter does not recite something significantly different than the judicial exception itself.
In evaluating the third inquiry with respect to whether the claims as a whole recites something significantly different than the judicial exception, there is one factor (factors g) that weigh against patent eligibility. As discussed above, factors g weighs against patent eligibility as the claims recites something that appears to be a natural product that is not markedly different in structure from naturally occurring products. Thus, in weighing the totality of the factors, the presently claimed invention is deemed patent ineligible subject matter. Therefore, in evaluating the totality of the relevant factors weighing against patent ineligibility the presently claimed invention is NOT markedly different from the judicial exception.
Claim Rejections - 35 USC § 112-Paragraph B
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 14-15 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 14 is directed to the composition of claim 14 wherein the at least one terpene is beta caryophyllene and myrcene. The metes and bounds of the claim are unclear as the claim depends from itself. Accordingly, one of ordinary skill in the art prior to the time of the invention would not have been apprised of the metes and bounds of the subject matter for which Applicant was presently seeking protection.
For the purposes of examination, the examiner has interpreted that claim 14 depend from claim 13, and subsequent examination is based on this interpretation.
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(s) 1-4, 8-11, 13, 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cranford (US2018/0193304 published 07/12/2018).
Cranford teaches the cannabinoid composition comprising 14.7% wt. cannabidiol, 1.07 %wt. cannabichromene, 3.6%wt. cannabigerol, 0.97%wt. cannabinol and 20.4%wt. of the terpene beta-caryophyllene ([0019]-[0038]). Regarding the claimed limitation directed to use of the cannabinoid composition of Cranford as a sleep aid, or as pain management or used to promote neurogenesis, such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e., an intent to use the disclosed composition as a medicament for sleeping, pain or promoting neurogenesis), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble of not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP §2112.02(11). In the instant case, the cited prior art cannabinoid composition of Cranford meets each and every structural and physical limitation of the instantly claimed composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Claim(s) 1-4, 6-11, 13-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Adair (WO2022/232574 published 11/03/2022).
Adair (WO2022/232574 published 11/03/2022) teaches cannabinoid product 5 comprising 53.8%wt. cannabidiol (CBD) 2.63%wt. cannabigerol (CBG), 0.76%wt. cannabinol (CBN), 7.53%wt. cannabichromene (CBC) and the terpenes beta-caryophyllene and myrcene, wherein beta-caryophyllene is present in 1.48%wt. and myrcene is present in 0.58% wt. ([0039], [0076]-[0077], Tables 3-4). Regarding the claimed limitation directed to use of the cannabinoid composition of Adair as a sleep aid, or as pain management or used to promote neurogenesis, such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e., an intent to use the disclosed composition as a medicament for sleeping, pain or promoting neurogenesis), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble of not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP §2112.02(11). In the instant case, the cited prior art cannabinoid composition of Adair meets each and every structural and physical limitation of the instantly claimed composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Adair (WO2022/232574 published 11/03/2022).
Adair (WO2022/232574 published 11/03/2022) teaches cannabinoid product 5 comprising 53.8%wt. cannabidiol (CBD) 2.63%wt. cannabigerol (CBG), 0.76%wt. cannabinol (CBN), 7.53%wt. cannabichromene (CBC) and the terpenes beta-caryophyllene and myrcene, wherein beta-caryophyllene is present in 1.48%wt. and myrcene is present in 0.58% wt. ([0039], [0076]-[0077], Tables 3-4).
Adair additionally teaches that the cannabinoid concentrations can be adjusted to wherein cannabidiol (CBD) is present in a concentration of 30-70% of the composition, cannabigerol (CBG) is present in from 0-5%, cannabichromene is present in 1-20%, cannabinol is present in 1-15% of the composition ([0039]-[0040]). Adair further teaches that the total terpene concentration in the formulation is from about 2-10% wt. of the composition, wherein the terpenes include beta-caryophyllene and beta myrcene ([0041]). The amounts of cannabigerol, cannabichromene, cannabinol and terpenes beta-caryophyllene and myrcene overlap with the amounts embraced within the present claims. Applicant is reminded of MPEP 2144.05 wherein the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, one of ordinary skill in the art prior to the time of the invention would have found it prima facie obvious to adjust the concentrations of cannabidiol, cannabinol cannabichromene and cannabigerol as well as the terpenes beta-caryophyllene and myrcene in the cannabinoid composition of Adair in order to arrive at the presently claimed cannabinoid composition comprising 90%wt. cannabidiol, 4% wt. cannabigerol, 2% wt. cannabichromene, 2% wt. cannabinol, 1.5% beta-caryophyllene and 0.5% myrcene in view of Adair. Motivation to adjust the concentrations of cannabidiol, cannabinol cannabichromene and cannabigerol in the cannabinoid composition as well as the terpenes beta-caryophyllene and myrcene logically flows from the fact that Adair teaches that both the terpene and the cannabinoid concentrations can be adjusted to wherein cannabidiol (CBD) is present in a concentration of 30-70% of the composition, cannabigerol (CBG) is present in from 0-5%, cannabichromene is present in 1-20%, cannabinol is present in 1-15% of the composition while the terpenes can be present in 2-10% wt. of the composition([0039]-[0041, Tables 3-4]).
It is noted that Adair does not specifically teach wherein cannabidiol is present in 90% wt. of the cannabinoid composition. However, it is considered well within the capabilities of one of ordinary skill in the art to optimize the amount of cannabidiol in the cannabinoid composition to provide optimal amounts of cannabidiol in the cannabidiol-dominant formulation. The amount of cannabidiol in the formulation comprising cannabidiol, cannabinol cannabichromene and cannabigerol is a result effective parameter that will affect the physical properties of the final composition. The amount of cannabidiol in the formulation comprising cannabidiol, cannabinol cannabichromene and cannabigerol is clearly a results effective parameter that a person of ordinary skill would routinely optimize. Optimization of parameters is a routine practice that would have been obvious for a person of ordinary skill in the art to employ and reasonably would expect success. Moreover, Adair provides a range of workable conditions and it would have been customary for an artisan of ordinary skill to determine the optimal amount of cannabidiol in the formulation comprising cannabidiol, cannabinol cannabichromene and cannabigerol to best achieve the desired result. Furthermore, absent any evidence demonstrating a patentable difference between the composition and the criticality of the claimed amounts, the determination of the optimum workable range(s) given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II) (A) and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) “[W]here the general conditions of the claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Lastly, regarding the claimed limitation directed to use of the cannabinoid composition of Adair as a sleep aid, or as pain management or used to promote neurogenesis, such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e., an intent to use the disclosed composition as a medicament for sleeping, pain or promoting neurogenesis), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble of not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP §2112.02(11). In the instant case, the cited prior art cannabinoid composition of Adair meets each and every structural and physical limitation of the instantly claimed composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Conclusion
In view of the rejections set forth above, no claim is allowed.
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/GEORGE W KOSTURKO/Examiner, Art Unit 1621