DETAILED ACTION
Claims 1-11 are pending.
Claim Objections
1.Claim 1 is objected to because of the following informalities: Claim 1 recites “The cannabinoid receptor…”, however, it should recite “A cannabinoid receptor…”. Appropriate correction is required.
Claim Interpretation
Claims 1-2 and 6-11 do not recite any particular sequence and reads broadly on any cannabinoid receptor biomarker. Move over, the instant specification teaches that the cannabinoid receptor biomarker is a ligand that binds specifically to the cannabinoid receptor ([0036]).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
2.Claims 1-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The fundamental factual inquiry is whether the specification conveys with reasonable
clarity to those skilled in the art that, as of the filing date sought, applicant was in possession of
the invention as now claimed. See, e.g., Vas-Cath, Inc., 935 F.2d at 1563-64, 19 USPQ2d at
1117.
The factors to be considered when analyzing claims for compliance with the written description requirement include: actual reduction to practice; disclosure of drawings or structural
chemical formulas; sufficient relevant identifying characteristics (e.g., disclosure of complete or
partial structure, physical and/or chemical properties, structure/function correlation); method of
making the claimed invention; level of skill and knowledge in the art; and predictability in the art.
See MPEP §2163.
Instant claim 1 is drawn to “a cannabinoid receptor biomarker that has the amino acid sequences or proteins having the same amino acid sequences where one or more amino acids are added, deleted, or substituted and having receptor activity via binding to cannabinoids”.
The specification does not provide any structure/function correlation. The specification teaches that the amino acid sequences are “AxCBM1” and “AxCBM2” (see [0026]), however, “AxCBM1” and “AxCBM2 are not known biomarkers in the art. The instant specification teaches that AxCBM1 and AxCBM2 are biomarkers that are able to recognize cannabinoid receptors 1 and/or 2 (see [0026]). Since the specification points to proteins that are not known in the art, the proteins structures thus vary substantially within the given claimed recitations. Given the breadth of the claims, since the claim does not read on any particular sequence per se and reads broadly on any cannabinoid receptor. Given the broad definition, this covers any variation of any sequence without any guidance it covers a wide genus with widely varying species. Further, there is no direction as to what the amino acids are, thus it is unknown what would be deleted, substituted, or added. There is no structure/function correlation. Lastly, the claim is directed towards a “cannabinoid receptor biomarker”, which broadly reads on any biomarker that binds to a cannabinoid receptor. This disclosure of “AxCBM1” and “AxCBM2” does not provide adequate written description of the claimed protein. Thus, the scope of the claims includes numerous structural variants. Claim 1 and its dependent claims are drawn to a method of using undefined structures.
The skilled artisan cannot envision the detailed structural formula for each biomarker
claimed (if any) which have the ability to (1) having receptor activity via binding to CB1 and/or CB2; and (2) having the same amino acid sequences where one or more amino acids are added, deleted, or substituted.
Therefore, the full breadth of independent claim 1 and its dependent claims do not meet the written description provision of 35 U.S.C. §112, first paragraph.
Instant claim 2 recites “A cannabinoid receptor biomarker protein encoded by a DNA sequence that hybridizes with the DNA sequence or its complementary sequence and having activity to detect cannabinoid receptor activity”.
The specification does not provide any structure/function correlation. The specification does not describe a cannabinoid receptor biomarker protein that are encoded by DNA sequences that hybridize with the DNA sequence or its complementary sequence and having activity to detect cannabinoid receptor activity. The biomarkers structure thus varies substantially within the given claimed recitation. As there is no definition, the biomarker would encompass a broad genus with a widely varying species of any protein that can be encoded by DNA sequences, that can hybridize with the DNA sequence or its complementary sequence, and has the ability to detect cannabinoid receptor activity.
The specification provides no examples of protein biomarkers that correlate to any specific function. Further, the specification fails to disclose the structures common to all potential biomarkers. Thus, there is no disclosure of the potential biomarkers and the specification does not provide adequate written description of the claimed biomarker. The scope of the claims includes numerous structural variants. Claim 2 and its dependent claims are drawn to a method of using undefined structures.
The skilled artisan cannot envision the detailed structural formula for each biomarker claimed (if any) which have the ability to (1) be encoded by DNA sequences, (2) hybridize with the DNA sequence or its complementary sequence, and (3) has the ability to detect cannabinoid receptor activity.
Therefore, the full breadth of independent claim 2 and its dependent claims do not meet the written description provision of 35 U.S.C. §112, first paragraph.
Instant claim 3 recites “The recombinant DNA sequence encoding the protein of any one of claims 1 and 2, wherein said nucleotide sequence consists of SEQ ID NO: 1 and 2 or full length complements thereof; and (b) a nucleotide sequence having at least 80% sequence identity to SEQ ID NO: 1 and 2”.
While claim 3 provides SEQ ID NOs: 1 and 2, the specification fails to disclose any species of proteins that are at least 80% identical to SEQ ID No: 1 and SEQ ID No: 2. The specification does not provide any structure/function correlation. The specification does not provide any guidance regarding which specific residues can be varied while still maintaining binding specificity. The specification does not disclose any species and thus does not provide a sufficient representation of the broad genus of different proteins that are encompassed by the present claim. Claim 3 and its dependent claims are drawn to a method of using undefined structures.
The specification does not disclose a single protein having at least 80% sequence identity to SEQ ID No:1 and SEQ ID No: 2. The claims are inclusive to a genus of protein which possess the unique capabilities of having at least 80% sequence identity to SEQ ID No: 1 and SEQ ID No: 2 which still maintaining binding specificity and a skilled artisan cannot envision the detailed chemical structure encompassed by the claimed agents (if any).
Therefore, the full breadth of independent claim 3 and its dependent claims do not meet the written description provision of 35 U.S.C. §112, first paragraph.
While generically the structure of antibodies is known, the structure of the presently
recited antibodies can vary substantially within the above given claimed recitations. As noted in
Amgen, knowledge that an antibody binds to a particular epitope on an antigen tells one nothing
at all about the structure of the antibody, wherein “instead of analogizing the antibody-antigen
relationship to a ‘key in a lock,’ it [is] more apt to analogize it to a lock and ‘a ring with a million
keys on it.” (Internal citations omitted). The relevant antibody art confirms this quandary,
indicating that “knowledge of an epitope or antigen used to generate a monoclonal antibody is insufficient for making the original antibody available, even if suitable in vitro test systems for
screening are used.” See p. 8, lines 3-5 of WO 2009/033743 A1. Therefore, those of skill in the
art would not accept that the inventor had been in possession of the full genus of nanobodies
encompassed by the claims.
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111 (Fed. Cir. 1991), clearly states that
“applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date
sought, he or she was in possession of the invention. The invention is, for purposes of the
‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does
not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is
claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed chemical structure of the encompassed
claimed agents (if any), and therefore conception is not achieved until reduction to practice has
occurred, regardless of the complexity or simplicity of the method of identification. Adequate
written description requires more than a mere statement that it is part of the invention and
reference to a potential method of isolating it. The compound itself is required. See Fiers v.
Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co.
Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991).
Functionally defined genus claims can be inherently vulnerable to invalidity challenge for
lack of written description support, especially in technology fields that are highly unpredictable,
where it is difficult to establish a correlation between structure and function for the whole genus
or to predict what would be covered by the functionally claimed genus. Abbvie Deutschland
GMBH & Co. v. Janssen Biotech, Inc. (759 F.3d 1285 (Fed. Cir. 2014). “When a patent claims a
genus using functional language to define a desired result, the specification must demonstrate
that the applicant has made a generic invention that achieves the claimed result and do so by
showing that the applicant has invented species sufficient to support a claim to the functionally-
defined genus." Capon v. Eshhar, 418 F.3d 1349 (Fed. Cir. 2005).
Therefore, the full breadth of the claims does not meet the written description provision
of 35 U.S.C. §112, first paragraph. Applicants are reminded that Vas-Cath makes clear that the
written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see
page 1115).
Thus, claims 1-11 are rejected under 35 USC 112(a) for lack of written description.
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.
3.Claims 1-11 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.
A) Claims 1-11 are indefinite because independent claim 1 recites “having the amino acid sequences or proteins having the same amino acid sequences where one or more amino acids are added, deleted, or substituted”, however, there is no sequence. Since the claim does not depend on any particular sequence, it is unknown and unclear what is being added, deleted, or substituted. The metes and bounds of the “amino acid sequences or proteins” are unknown and one would not know what is being referred to.
B) Claims 6-8 and 11 are indefinite because they reference figures within the claims, making it unclear what parts of the figures are being claimed. The claims fail to set forth any indication of which parts of the figures are being claimed, or if it is the whole figure being claimed.
Further, MPEP § 2173.05(s) explicitly states “Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience”. The instant claims do not meet the criteria for an exceptional circumstance because the instant claims themselves define the invention.
MPEP § 2173.05(s) further states “reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims”. However, the instant claims are not pointing to specific elements in the figures, but only the figures themselves. Thus, it is unclear what is being referred to within claims 6-8 and 11.
C) 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 7 recites the broad recitation “a substrate”, and the claim also recites “including, but not limited to cannabinoids” which is the narrower statement of the range/limitation. 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.
D) Instant claim 7 recites “methods and applications of screening compounds…”. Neither “methods” or “applications” are defined by the claim. It is unclear if the instant claim refers to multiple methods, one method, or a software application. The metes and bounds of “methods and applications” are not defined completely and one would not know what is being referred to. Examiner recommends amending the claim to provide a clear definition of what is being claimed, such as, “A method for screening compounds…”.
E) Claim 11 recites “other diseases”. The term “other diseases” is a relative term which renders the claims indefinite. The term “other diseases” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill would not be reasonably apprised of the scope of the invention. The language results in ambiguity as to whether this is the embodiment under examination or is an example.
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.
5.1-11 are rejected under 35 U.S.C. 101 because the claimed product and method are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
A) In the instant application, claims 1-11 recite the use of cannabinoid receptor biomarkers, which is a protein. Because proteins are composed of matter, cannabinoid receptor biomarkers are a composition of matter, which is a statutory category of invention. As explained in the MPEP, it is not necessary to identify single category into which a claim falls, so long as it is clear that the claim falls into at least one category. MPEP 2106.03(I). Here, because the cannabinoid receptor biomarker is a composition of matter, the claim is to at least one category of invention (STEP 1: YES).
B) Regarding instant claims 7-8 and 11, Example 43 of “2019 PEG” is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims 7-8 and 11.
Regarding claim 1 of example 43 of the “2019 PEG” and per Step 1, the claim is
directed to a process, which is one of the statutory categories of invention as the claim recites
“A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a
blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3)
to identify the patient as having a non-responder phenotype; (b) administering a treatment to the
patient having a non-responder phenotype.” (Step 1: YES).
Similarly, instant claim 7 is directed to a statutory method that measures compounds (proteins) and correlating the levels of said protein with the activity of cannabinoid receptors (Step 1: YES).
Instant claim 8 is directed to a method that measures compounds (proteins) and correlating the levels to either enhancing or inhibitory activity of cannabinoid receptor activity (Step 1: YES).
Instant claim 11 is directed to a method that measures compounds (proteins) and correlating the levels of said protein with efficacy of cannabis, or hemp-based drug related to immune response suppression or other diseases (Step 1: YES).
Step 2A, Prong 1: Does the claim recite a judicial exception?
This part of the eligibility analysis evaluates whether the claim recites a judicial
exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
A) Regarding instant claims 1-11, Example 44 of the “2019 PEG” shows a similar fact
pattern. Claim 1 in example 44 is drawn to denveric acid. The markedly different characteristics
analysis is used to determine if the nature-based product limitation is a product of nature
exception. MPEP 2106.04(c)(I). Although the claim also recites a non-nature based product
limitation (the container), the markedly different characteristics analysis should be applied only
to the nature- based product limitation. MPEP 2106.04(c)(I)(A). The markedly different
characteristics analysis is performed by comparing the nature-based product limitation in the
claim to its naturally occurring counterpart to determine if it has markedly different
characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart
is naturally occurring denveric acid. When the claimed denveric acid is compared to this
counterpart, the comparison indicates that there are no differences in structure, function, or
other characteristics. Therefore, the claimed denveric acid is a product of nature exception.
Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013)
(naturally occurring things are “products of nature” which cannot be patented).”
Similarly, instant claims 1-11 recite the use of cannabinoid receptor biomarkers. The closest natural counterpart to cannabinoid receptor biomarkers is naturally occurring cannabinoid receptor biomarkers. When the claimed markers are compared to this counterpart, the comparison indicates that there are no differences in structure, function, or other characteristics.
Accordingly, instant claims 1-11 recite a judicial exception (a product of nature and an
abstract idea), and the analysis must therefore proceed to Step 2A Prong Two.
B) Regarding instant claims 7-8 and 11, Example 43 of the “2019 PEG” shows a similar fact pattern.
Regarding claim 1 in Example 43 of the “2019 PEG” and per Step 2A, prong 1, the claim recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3)
to identify the patient as having a non-responder phenotype,” and according to broadest
reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the
ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent
phenotype.
Specifically, limitation (a) in claim 1 of Example 43 of the “2019 PEG” recites “calculating
a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic
Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder
phenotype,” which has a BRI that requires performing an arithmetic calculation (division) in
order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the
patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or
greater and thus is not responding, or will not respond, to glucocorticoids). This limitation
therefore recites a mathematical calculation. The grouping of “mathematical concepts” in the
2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG
Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping
of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be
practically performed in the human mind, and is in fact performed in the human mind on a daily
basis, for instance by school-aged children studying mathematics. Note that even if most
humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them
complete the recited calculation, the use of such physical aid does not negate the mental nature
of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract
ideas.
In addition, limitation (a) describes a naturally occurring relationship between the ratio
of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a
law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls
within the mathematical concept and mental process groupings in the “2019 PEG”, and a law of nature), and the analysis must therefore proceed to Step 2A Prong Two.
Similarly, instant claim 7 recites measuring compounds (proteins) and correlating the levels of said protein with the activity of cannabinoid receptors, and thus is considered a law of nature. Further, instant claim 7 recites “(b) comparing the cannabinoid receptor activity detected in step (a) with that detected in the absence of the test compounds”, which is directed toward an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). Comparing collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind. Consequently, instant claim 7 recite the judicial exception of applying and using a law of nature and an abstract idea.
Instant claim 8 recites measuring compounds (proteins) and correlating the levels to either enhancing or inhibitory activity of cannabinoid receptor activity, which is considered a law of nature. Further, instant claim 8 recites “(b) comparing the cannabinoid receptor activity detected in step (a) with that detected in the absence of the test compounds; and (c) selecting a compound that lowers or increases the activity of cannabinoid receptors of any one of claims 1 and 2”, which is directed toward an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). Comparing collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind. The language of “selecting” is also directed to a judicial exception as it is an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion), as “selecting” can be done in the mind. Consequently, instant claim 8 recite the judicial exception of applying and using a law of nature and an abstract idea.
Instant claim 11 recites measuring compounds (proteins) and correlating the levels of said protein with efficacy of cannabis, or hemp-based drug related to immune response suppression or other diseases, which is considered a law of nature. Consequently, instant claim 11 recites a judicial exception of applying and using a law of nature.
Accordingly, instant claims 7-8 and 11 recite a judicial exception (a law of nature and an abstract idea that falls within the mental process grouping) and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong 2: Does the claim recite additional elements that integrate the exception into a practical application?
A) Regarding instant claims 1-11, Example 44 of the “2019 PEG” shows a similar fact
pattern. In claim 1 of example 44 of the “2019 PEG” and per Step2A, Prong two, the evaluation
is performed by (a) identifying whether there are any additional elements recited in the claim
beyond the judicial exception, and (b) evaluating those additional elements individually and in
combination to determine whether the claim as a whole integrates the exception into a practical
application. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Claim 1 recites an additional
element (the container). Although this limitation indicates that the denveric acid is held in the
container, it does not provide any information as to how the denveric acid is contained, or what
the container is, but instead covers any possible container that a doctor or pharmacist decides
to use. Because denveric acid must be placed in a container in order to store and use it, merely
reciting a generic “container” thus fails to meaningfully limit the claim because it is at best the
equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the
container does not integrate the recited judicial exception into a practical application and the
claim is therefore directed to the judicial exception (Step 2A: YES)”.
While example 44 recites a container which was still was not deemed sufficient, instant claims 1-11 do not recite any container and contains no more than the cannabinoid receptor biomarker (the natural product). Example 44 did not pass Step 2A prong 2 with an additional element (the container). Accordingly, instant claims 1-11 do not have additional elements that would integrate the judicial exception cited above into a practical application.
Therefore, instant claims 1-11 do not integrate the judicial exception into a practical application.
B) Regarding instant claims 7-8 and 11, Example 43 of “2019 PEG” shows a similar fact pattern.
In claim 1 of example 43 of the “2019 PEG” and per Step 2A, prong 2, the claim as a
whole does not integrate the recited judicial exception into a practical application of the
exception. This evaluation is performed by (a) identifying whether there are any additional
elements recited in the claim beyond the judicial exception, and (b) evaluating those additional
elements individually and in combination to determine whether the claim as a whole integrates
the exception into a practical application. Besides the abstract idea, the claim 1 of example 43
of the “2019 PEG” recites the additional element of “(b) administering a treatment to the patient
having a non-responder phenotype”. Although this limitation indicates that a treatment is to be
administered, it does not provide any information as to how the patient is to be treated, or what
the treatment is, but instead covers any possible treatment that a doctor decides to administer
to the patient. In fact, this limitation is recited at such a high level of generality that it does not
even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into
account when deciding which treatment to administer, making the limitation’s inclusion in this
claim at best nominal. Thus, limitation (b) of example 43 of the “2019 PEG” fails to
meaningfully limit the claim because it does not require any particular application of the recited
calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial
exception. Accordingly, limitation (b) of example 43 of the “2019 PEG” does not integrate the
recited judicial exception into a practical application and the claim is therefore directed to the judicial exception.
Similarly, instant claim 7 does not have additional elements that would integrate the judicial exception cited above into a practical application. In comparison to claim 1, Example 43 did not pass step 2A prong 2 with a step of general treatment. Instant claim 7 doesn’t even recite a treatment step. Example 43 failed with a step of a general treatment, instant claim 7 does not recite a further active step, let alone a treatment.
Instant claim 8 does not have additional elements that would integrate the judicial exception cited above into a practical application. In comparison to claim 1, Example 43 did not pass step 2A prong 2 with a step of general treatment. Instant claim 8 doesn’t even recite a treatment step. Example 43 failed with a step of a general treatment, instant claim 8 does not recite a further active step, let alone a treatment.
Instant claim 11 does not have additional elements that would integrate the judicial exception cited above into a practical application. In comparison to claim 1, Example 43 did not pass step 2A prong 2 with a step of general treatment. Instant claim 11 doesn’t even recite a treatment step. Example 43 failed with a step of a general treatment, instant claim 11 does not recite a further active step, let alone a treatment.
Step 2B: Does the claim recite significantly more?
A) Regarding instant claims 1-11, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any
additional element, or combination of additional elements, adds an inventive concept to the
claim. MPEP 2106.05 As discussed with respect to Step 2A Prong Two, the claims do not even
recite a container or any additional elements. (Step 2B: NO). The claims are not eligible.
B) Regarding claim 1 of example 43 of the “2019 PEG” and per Step 2B, this part of the
eligibility analysis evaluates whether the claim as a whole amounts to significantly more than
the recited exception, i.e., whether any additional element, or combination of additional
elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to
Step 2A Prong Two, the claim recites a single additional element in limitation (b), which does
not require any particular application of the recited calculation and is at best the equivalent of
merely adding the words “apply it” to the judicial exception. Mere instructions to apply an
exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Similarly, instant claim 7 recites the additional limitation of “(a) contacting the proteins with a substrate all to be bound by these proteins in the presence of a test compound to detect the cannabinoid receptor activity of the proteins” which recite contacting naturally occurring proteins which are merely instructions of obtaining a judicial exception and cannot be considered an inventive concept. Instant claim 7 recites the additional limitation of and “(c) purifying the cannabinoid protein”, which is still patently ineligible. Purified cannabinoid protein remains structurally and functionally identical to the naturally occurring form, thus teaching a product of nature, and is not patent eligible merely because it has been purified (STEP 2B: NO).
Instant claim 8 recites the additional limitation of “(a) contacting the proteins of any one of claims 1 and 2 with a substrate to be bound by these proteins in the presence of a test compound to detect the cannabinoid receptor activity of the protein of any one of claims 1 and 2”, which recite contacting naturally occurring proteins which are merely instructions of obtaining a judicial exception and cannot be considered an inventive concept (STEP 2B: NO).
Instant claim 11 does not recite any additional limitations that would amount to significantly more (STEP 2B: NO).
Thus, instant claims 1-11 are rejected under 35 USC 101.
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.
(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.
6.Claims 1-2, 7-8, and 10 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Svetlov et al., US7611858B1 (effectively filed on 04/20/2007).
Given the breadth of claim 1 and notwithstanding 112(a) and 112(b) issues, the claims are not distinguished from Svetlov.
Svetlov teaches cannabinoid receptor biomarkers having receptor activity via binding to cannabinoids (see column 1 lines 22-25, see column 13 lines 20-56, see column 14 lines 36-47, see column 23 lines 51-65) (instant claims 1-2). Svetlov teaches an analysis utilizing the cannabinoid receptor in claims 1-2 (see claim 1 of Svetlov) (instant claim 10). Svetlov teaches (a) contacting the cannabinoid receptor biomarker with a cannabinoid to detect the cannabinoid receptor activity of the cannabinoid (see column 13 lines 20-55, see column 14 lines 36-47); comparing the cannabinoid receptor activity of (a) with a control (see column 14 lines 6-11, see column 27 lines 1-6), selecting a compound that lowers or increases activity of cannabinoid receptors (see column 14 lines 36-47); and purifying the cannabinoid receptor of the protein (see column 32 lines 15-17, see column 5 lines 31-37) (instant claims 7-8).
7.Claims 1-2 and 10-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ketcherside et al., “Cannabinoid Receptor 1 Gene by Cannabis Use Interaction on CB1 Receptor Density.” Cannabis and cannabinoid research vol. 2,1 202-209. 1 Aug. 2017, doi:10.1089/can.2017.0007
Given the breadth of claim 1 and notwithstanding 112(a) and 112(b) issues, the claims are not distinguished from Ketcherside.
Ketcherside teaches cannabinoid receptor biomarkers having receptor activity via binding to cannabinoids (see background, see page 202 “The human cannabinoid 1 (CB1) receptor is part of the endocannabinoid system (ECS), which is highly regulatory in various functions throughout the body, including the central nervous system(CNS) and the digestive, reproductive, and urinary tracts.1,2 The primary psychoactive component of cannabis, delta-9-tetrahydrocannabinol (THC), binds to CB1, and this binding in the CNS is responsible for the psychoactive effects of cannabis.”, see page 203 “THC’s binding to CB1 has been shown to alter immune function in rodents, indicating that exogenous cannabinoids may induce changes in these lymphocytes directly through cannabinoid receptor activation.”) (instant claims 1-2). Ketcherside teaches analysis utilizing cannabinoid receptors (see page 202 under “methods” and “results”) (instant claim 10). Ketcherside teaches testing of pharmacokinetics of cannabinoid receptor CB1 in order to obtain information about the efficacy of cannabis or hemp-based drugs related to immune response suppression or other diseases (see page 202 under “background:” and “conclusion”, see page 203 “THC's binding to CB1 has been shown to alter immune function in rodents,19 indicating that exogenous cannabinoids may induce changes in these lymphocytes directly through cannabinoid receptor activation.”) (instant claim 11).
8.Claims 1-2 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rodrigues et al., “Interaction between Cannabinoid Type 1 and Type 2 Receptors in the Modulation of Subventricular Zone and Dentate Gyrus Neurogenesis.” Frontiers in pharmacology vol. 8 516. 10 Aug. 2017, doi:10.3389/fphar.2017.00516.
Given the breadth of claim 1 and notwithstanding 112(a) and 112(b) issues, the claims are not distinguished from Rodrigues.
Rodrigues teaches cannabinoid receptor biomarkers having receptor activity via binding to cannabinoids (see page 8 under “CB1R and CB2R Activation Induces SVZ Neuronal Differentiation”, see page 2 “In recent years, an increasing interest has emerged on the role of endocannabinoids in neurogenesis. Cannabinoids act mainly on two types of receptors, type 1 and type 2 cannabinoid receptors (CB1R and CB2R). CB1R is considered the neuronal receptor whereas CB2R is considered the receptor of the immune system (Galve-Roperh et al., 2007)… Besides their neuromodulatory role, endocannabinoids constitute a group of signaling cues that can regulate neurogenesis at several levels, including NSPC proliferation, differentiation, migration and survival, these actions being associated to either CB1R or CB2R”) (instant claims 1-2). Rodrigues teaches a composition using two cannabinoid receptor biomarkers in a composition (see page 22 “SVZ cells incubated with the selective agonists for CB1R and CB2R that were pre-treated with the CB2R selective antagonist. These findings suggest a negative crosstalk between CB1R and CB2R.”… Treatment with the CB1R and CB2R non-selective agonist also stimulated DG neuronal differentiation.”) (instant claim 9).
Applicant is reminded that the claim interpretation in the paragraph above does not recite any particular sequence and thus reads on any ligand that binds specifically to the cannabinoid receptor.
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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