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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----12/29/2023, which is a national stage application of PCT/US2022/035708 filed 6/30/2022, which claims domestic priority to 63/218,137 filed 7/2/2021.
As filed, claims 10, 11, 13, and 15-26 are pending; and claims 1-9, 12, and 14 are cancelled.
Election/Restrictions
Applicant’s election of Group I – Claims 10, 11, 13, 15-19, and 24-26 in the reply filed on 7/14/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 20-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Regarding the election of species requirement, Applicant elected the species of cannabigerolic acid (CBGA), which is found in pg. 41 of the instant specification. The claims, which read on the elected species, are instant claims 10, 11, 13, 16-18, and 24-26, according to Applicant’s reply filed on 7/14/2026. However, the Examiner finds that claim 18 does not read on the elected species of CBGA and thus, only claims 10, 11, 13, 16, 17, and 24-26 will be examined herein.
Claims 15, 18, and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does not make a contribution over the prior art.
According to MPEP 803.02: should the elected species appear non-allowable, the search of the Markush-type claim will not be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/19/2023 and 6/22/2026 has been considered by the Examiner.
Claim Rejections - 35 USC § 112(a)
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.
Claims 10, 11, 13, 16, 17, and 24-26 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating a β coronavirus-induced disease via a cannabinoid acid, does not reasonably provide enablement for preventing infection by a β coronavirus via a cannabinoid acid. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
As stated in the MPEP § 2164.01(a): “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is ‘undue’.” In In re Wands (8 USPQ2d 1400 (Fed. Cir. 1988)), the Federal Circuit established that the following factors are to be considered when determining whether a disclosure meets the enablement requirement of the first paragraph of 35 U.S.C. § 112:
The nature of the invention - is a method of preventing infection by a β coronavirus or treating a β coronavirus-induced disease via a number of cannabinoid acids depicted in claim 10.
The state of the prior art - the pharmacological art requires the screening of potential drug candidates in vitro and in vivo to determine if the drug candidates exhibit the desired pharmacological activities.
In order to treat a disease: one would need to precisely identify what the disease is, identify what biological target is connected with the disease, demonstrate that the drug candidate in some way modulates the normal processes of the biological target, and demonstrate that a patient benefited from such modification without detrimental side effects. Typically, this process includes in vitro laboratory screening, preclinical in vivo screening, and three phases of clinical trials. Once this arduous process has been successfully completed by a drug candidate, subsequent drug candidates will benefit from the established proof of concept. The subsequent drug candidates must demonstrate a substantial correlation between their biological activity and that of the known drug candidate.
In order to prevent a disease: one would need to precisely identify those subjects likely to acquire such a disease, administer Applicant’s claimed invention, and demonstrate that the patient did not develop the disease as a result of the administration of the claim invention.
In the instant case, the prior arts recognize that a number of cannabinoid acids can treat infection by a β coronavirus or treat a β coronavirus-induced disease, such as COV-19, etc. via a cannabinoid acid. For example, see U.S. Patent Application Publication No. 2023/0270763.
The predictability or unpredictability of the art – the law recognizes the pharmaceutical art as an unpredictable art and requires each embodiment to be individually assessed for physiological activity. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970). Accordingly, the more unpredictable an area is the more specific disclosure is necessary in order to satisfy the statute. Section 2164.02 of the MPEP provides:
"[C]orrelation” as used herein refers to the relationship between in vitro and in
vivo animal model assays and a disclosed or a claimed method of use . . . if the
art is such that a particular model is recognized as correlating to a specific
condition, then it should be accepted as correlating unless the examiner has
evidence that the model does not correlate.
In light of these remarks, the Examiner finds that one of ordinary skill in the art would agree with the court; that is, the pharmaceutical art is unpredictable. Thus, a substantial correlation is necessary for establishing the potential of new therapeutics.
The amount of direction or guidance presented – the instant specification briefly provides an explanation of the biological activity of β coronavirus on pp. 1-2, including references that discuss the implication of cannabinoid acid in the treatment of the infection by a β coronavirus or a β coronavirus-induced disease. There is no direction or guidance provided that supports a use of cannabinoid acid as a drug for preventing infection by a β coronavirus, as instantly embraced.
The amount of guidance or direction to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. MPEP § 2164.03 (quoting In re Fisher, 427 F.2d 833, 839, 166 USPQ 18 24 (CCPA 1970)). As identified supra, the pharmaceutical art is recognized as unpredictable.
Thus, in order to support a claim for preventing infection by a β coronavirus, a vast amount of evidence is required because such a claim is not supported by the prior art or the instant specification.
The presence or absence of working examples - there are no working or prophetic examples in the specification that demonstrate that the instant cannabinoid acids or composition thereof may prevent infection by a β coronavirus, as instantly embraced. The assays in the specification demonstrate that the instant cannabinoid acids were tested for their ability to block cellular entry of SARS-CoV-2, etc. (pg. 37-59 of the instant specification)
The breadth of the claims – is incommensurate in scope with the disclosure because a fair reading of the specification fails to support a finding that the instant cannabinoid acids may prevent infection by a β coronavirus in a patient.
The quantity of experimentation necessary – generally speaking, the amount of experimentation to transform a molecule into medicine is vast and the success thereof is low. Recent statistics indicate that the attrition rates during drug development remain high. Schafer et al. Drug Discovery Today 2008, 13 (21/22), 913-916. The article makes clear that there are many steps necessary to promote a new molecular entity toward its clinical use, any one of which is cumbersome.
For instance, Schafer et al. discloses: "proof of concept trials have failed when the decision to enter clinical development was based on preclinical experiments using the wrong compound, the wrong experimental model, or the wrong endpoint.” It can be gleaned from this article that a plethora of experimentation is needed to identify the lead compound (i.e. one among many in a Markush-type claim), to establish which preclinical tests are predictive of clinical success, and to establish which diseases are the best to target for each lead compound.
There is generally a vast amount of experimentation to take a drug from bench to the clinic. See e.g., Horig et al. Journal of Translational Medicine 2004, 2(44) (“Successful drug development requires satisfying a matrix of domains from relevance to the disease and the drug-ability of the target through feasibility and convenience of drug delivery, demonstration of favorable benefit-risk profile in order to achieve a drug label that reflects physician and patent acceptance.") The Examiner finds that one of ordinary skill in the art would agree with the statements in these articles; that is, the amount of experimentation required to enable a pharmaceutical drug is extensive.
The level of skill in the art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of the active workers in the field of pharmaceuticals and/or medicine, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in a field related to medicine and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
Conclusion – Claims 10, 11, 13, 16, 17, and 24-26 are rejected because the Examiner finds that the Wands factors suggest a conclusion that the skilled artisan would not be able to make and use the instant invention without undue experimentation, although the level of skill for an ordinary person in the art is high. That is, due to the breadth of the claims, the unpredictability of the art, the lack of guidance or direction from the disclosure, the lack of any working examples, and the amount of experimentation needed illustrate that a person having ordinary skill in the art would not be able to prevent infection by a β coronavirus.
Claim Rejections - 35 USC § 112 fourth paragraph
The following is a quotation of the fourth paragraph of 35 U.S.C. § 112:
Subject to the following paragraph [concerning multiple dependent claims], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers (emphasis added).
Claims 16 and 17 are rejected under the fourth paragraph of 35 U.S.C. § 112 and under 37 CFR § 1.75(c), as being of improper dependent form for failing to further limit the subject matter of a previous claim. Applicant is required to cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
Regarding claims 16 and 17, the claims are dependent upon claim 10. The subject matter in claim 10 is drawn to a method of preventing infection by a β coronavirus or treating a β coronavirus-induced disease via a cannabinoid acid depicted in claim 10. The subject matter in claims 16 and 17 is drawn to a limited embodiment of the cannabinoid acid.
The scope of claims 16 and 17 is broader than scope of claim 10 because claims 16 and 17 include species that are outside of the cannabinoid acid (e.g. CBDA or THCA-A, or combination of CBDA and CBGA or combination of THCA-A and CBGA). Because the scope of claims 16 and 17 is broader than claim 10, the claims failed to further limit the subject matter thereof, and fail to comply with the formal requirements set forth in the fourth paragraph of 35 U.S.C § 112.
The Examiner suggests that the claims be amended in a manner such that the scope of claims 16 and 17 is commensurate with the scope of claim 10.
Claim Rejections - 35 USC § 102
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)(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.
Claims 10, 11, 13, 24 and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Publication No. 2023/0270763, hereinafter Deckwerth, as evidenced by “An overview of betacoronaviruses-associated severe respiratory syndromes, focusing on sex-type-specific immune responses”, hereinafter Rahimi.
Regarding claims 10, 11, 13, 24, and 25, Deckwerth, for instance, teaches oral or topical administration of CBGA and other cannabinoid acids for treating COV-19, which is caused by β coronavirus, as evidenced by Rahimi. All of which meet all the limitations of these claims.
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168
428
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(Deckwerth, paragraph 0146)
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270
424
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(Deckwerth, paragraph 0007)
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124
424
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(Deckwerth, paragraph 0080)
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170
760
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(Deckwerth, pg. 4, Table 1, example 5)
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558
432
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( Deckwerth, paragraph 0079)
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486
1076
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(Rahimi, abstract)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 16, 17, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Deckwerth, as evidenced by Rahimi.
Regarding claims 16 and 17:
Determining the scope and contents of the prior art:
Deckwerth, as evidenced by Rahimi, for instance, teaches the abovementioned process.
Ascertaining of the difference between the prior art and the claim at issue:
Deckwerth, as evidenced by Rahimi, for instance, did not explicitly teach the combination of CBGA with CBDA or with THCA-A.
Finding of prima facie obviousness --- rationale and motivation:
The preferred embodiments or blazemarks of Deckwerth, as shown below, will motivate a person of ordinary skill in the art to combine CBGA with one or more therapeutic agent, which can include CBDA or THCA-A, according to MPEP 2144.06.
According to MPEP 2144.06, the Examiner finds that it would have been obvious to one of ordinary skill in the art to combine CBGA with CBDA or with THCA-A in order to arrive at the instantly claimed combination because CBGA, CBDA and THCA-A are all used as cannabinoid compounds for treating COV-19, which is the same purpose as the instantly claimed combination. In addition, there’s a reasonable expectation of success that the abovementioned combination will retain the property of treating COV-19.
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174
776
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(pg. 6, Table 1, example 17)
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166
757
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(pg. 8, Table 1, example 26)
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292
654
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(pagraph 0067)
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164
666
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(paragraph 0024)
Regarding claim 26:
Determining the scope and contents of the prior art:
Deckwerth, as evidenced by Rahimi, for instance, teaches the abovementioned process.
Ascertaining of the difference between the prior art and the claim at issue:
Deckwerth, as evidenced by Rahimi, for instance, did not explicitly teach the administration of CBGA is inhaled.
Finding of prima facie obviousness --- rationale and motivation:
The Examiner does not find the abovementioned route of administration as result-effective variable because the Applicant fails to demonstrate this parameter to impart any unexpected or novel aspect to the instant process (i.e. no comparative example). “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05. Accordingly, this parameter is viewed as routine experimentation to optimize the instant process, and not a patentable distinction.
Conclusion
Claims 10, 11, 13, 16, 17, and 24-26 are rejected.
Claims 15, 18, 19, and 20-23 are withdrawn.
Claims 1-9, 12, and 14 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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