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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/07/2026 has been entered.
Status of the Claims
Claims 14-16 and 22-28 are pending in this application. Claims 1-13 and 17-21 have been cancelled by applicant.
Claim Objections
Please amend lines 4 and 7 of claim 1 as follows for clarity: “…solvate or hydrate geometric isomer…” – see 112(b).
Please amend claim 27 as follows for clarity: “…solvate or hydrate geometric isomer…” – see 112(b).
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.
Claims 14-16 and 22-28 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.
Claims 14 and 27 recite the limitation "the isomer". There is insufficient antecedent basis for this limitation in the claims, which refer to “a geometric isomer.”
Claims 15-16, 22-26 and 28 are rejected for depending upon the limitations of claim 14 without remedying the deficiencies thereof.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), 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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
Claims 26-28 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 26-28 are rejected because they fail to further limit claim 14 from which they depend. Claim 14 refers to a method of inhibiting the replication and/ or reproduction of SARS-CoV-2 comprising contacting a cell with CBD as the sole pharmaceutically active ingredient. Claims 26-27, however, broaden this limitation to encompass contacting the cells with an additional antiviral active ingredient.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 14-16 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Biochem. Mol. Bio., doi:10.20944/preprints202004.0315.v1, 12 pages – Not Peer Reviewed Version Published April 19th, 2020 – Final form cited in IDS – previously cited) (“Wang”); in view of Earlenbaugh et al. [Obtained from blissfullwellnesshealth.com [retrieved on 08/13/2026] <URL: https://blissfulwellnesshealth.com/blissful-times/cbd-and-its-role-in-the-fight-against-covid/> - Pub Date: Jul 9th 2020) (“Earlenbaugh”).
Regarding claim 14, Wang discloses that it is now well accepted that angiotensin-converting enzyme II (ACE2) is the cell receptor of SARS-CoV-2 and the main route for receptor-mediated entry of the virus into the human host. Since ACE2 plays a pivotal role in cellular entry, ACE2 expressing cells serve as critical viral gateways (for viral replication) (page 2, lines 16-20). Wang teaches that high-cannabidiol (CBD) sativa extracts may be used to modulate ACE2 and TMPRSS2, which are disclosed as critical proteins required for SARS-CoV-2 entry into host cells (abstract). Wang discloses dilution of CBD extracts to about 0.01 mg/mL for their experiments, treating different tissue models with their extract solution (page 3, end of para. 1 and section 2.2).
Regarding claims 15 and 22-23, Wang’s disclosure focuses specifically on human host cells, as they mention SARS-CoV-2 uses receptor-mediated entry into the human host via ACE2, expressed in lung tissue, as well as oral and nasal mucosa, kidney, testes, and the
gastrointestinal tract. (abstract, lines 5-8). See also Section 2.2, page 3 and Figure 1, page 6 where different human tissue cells are disclosed.
Regarding claims 16 and 24, Wang discloses their isolated CBD extracts in a DMSO (a carrier and liquid preparation) (page 3, para. 1, lines 9-11).
While Wang does not specifically teach: (i) administration wherein CBD is the only active ingredient; the teachings of Earlenbaugh are relied upon for these disclosures.
Earlenbaugh teaches CBD has been shown to increase the production of interferons, a type of signaling protein that activates immune cells and prevents viruses from replicating (page 2, end of para. 2). Earlenbaugh specifically focuses on SARS-CoV-2 and COVID19 in their report.
Therefore, regarding claim 14, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to contact a cell with an effective amount of CBD as the sole pharmaceutically active ingredient to inhibit the replication of SARS-CoV-2. One of ordinary skill would have been motivated to do so because Wang discloses CBD sativa extracts may be used to modulate ACE2 and TMPRSS2, which are disclosed as critical proteins required for SARS-CoV-2 entry into host cells; and because Earlenbaugh discloses CBD can help with COVID19, specifically stating that CBD has been shown to increase the production of interferons, a type of signaling protein that activates immune cells and prevents viruses from replicating. One of ordinary skill would have had a reasonable expectation of success in view of the disclosures above.
Claims 25-28 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Biochem. Mol. Bio., doi:10.20944/preprints202004.0315.v1, 12 pages – Not Peer Reviewed Version Published April 19th, 2020 – Final form cited in IDS – previously cited) (“Wang”); in view of Earlenbaugh et al. [Obtained from blissfullwellnesshealth.com [retrieved on 08/13/2026] <URL: https://blissfulwellnesshealth.com/blissful-times/cbd-and-its-role-in-the-fight-against-covid/> - Pub Date: Jul 9th 2020) (“Earlenbaugh”); as applied to claims 14-16 and 22-24; in view of Hava et al. (US 2013/0203715 A1 – previously cited – cited in IDS – previously cited) (“Hava”).
The teachings of Wang and Earlenbaugh are disclosed above and incorporated herein.
While Wang in view of Earlenbaugh does not specifically teach: (i) wherein the administered composition is a tablet, injection, or spray (claim 25); or (ii) wherein the CBD is administered with another antiviral (simultaneously, sequentially or separately), wherein the other antiviral is selected from those in claim 28 (claims 26-28); the teachings of Hava are relied upon for these disclosures.
Hava discloses a method of treating a viral infection, including SARS-CoV (Hava’s claim 5; and [0056] line 8) comprising administration of CBD ([0014], last line of col. 1; and claim 9), thus suggesting a single active ingredient in their formulation. Hava teaches their composition may be in any suitable form, such as a spray (page 24 and [0077], lines 1-5). Hava discloses their composition further comprising a co-therapeutic agent, such as an anti-viral ([0074], lines 1-6). Hava further discloses co-therapeutic agent may be administered before, after, or concurrently with the CBD ([0074], col. 2, top 3 lines, page 7), and teaches co-therapeutic antiviral agents, such as amantadine [0095].
Therefore, regarding claim 25, it would have been prima facie obvious before the effective filing of the claimed invention to contact a cell with CBD in spray form to inhibit SARS-CoV-2 replication. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Wang in view of Earlenbaugh disclose a method of inhibiting SARS-CoV-2 replication comprising contacting cells with CBD; and because Hava discloses CBD compositions may be in the form of a spray for treating viral infections. Thus, one of ordinary skill would have been motivated to prepare a spray formulation comprising CBD in a carrier in order to spray cells, thus maximizing efficacy of the contacting of cells with CBD in order to inhibit SARS-CoV-2 replication. One of ordinary skill would have further had a reasonable expectation of success in view of Wang’s disclosure of a CBD composition in DMSO; and Hava’s disclosure of a CBD composition in spray form.
Regarding claims 26-28, Hava discloses their composition further comprising a co-therapeutic agent, such as an anti-viral like amantadine ([0074], lines 1-6; and [0095]). Hava further discloses co-therapeutic agent may be administered before, after, or concurrently with the CBD ([0074], col. 2, top 3 lines, page 7). Therefore, it would have been prima facie obvious to one of ordinary skill to administer (Wang in view of Earlenbaugh)’s SARS-CoV-2 replication inhibitor, CBD, in combination with an additional antiviral, such as amantadine, in any order (simultaneously, separately, or sequentially).
Further comprising claim 27, Applicant is advised that the courts have held that any order of performing process steps is prima facie obvious in the absence of new or unexpected results (In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930); Ex Parte Rubin, 128 USPQ 440 (Bd. App. 1959)). See MPEP §2144.04 IV C. Therefore, the claimed order of steps is an obvious variant of the steps of the cited prior art.
Further regarding claims 26-28, Applicant is advised that with respect to a mixture of the two claimed reagents, the courts have found that “[i]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art (In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).” See MPEP2144.06. It is therefore obvious to provide a mixture of the two agents.
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Claim Rejections - 35 USC § 102
In view of claim amendments, previous 35 USC § 102 rejections have been withdrawn.
Claim Rejections - 35 USC § 103
In view of claim amendments, previous 35 USC § 103 rejections have been withdrawn. However, a new ground of rejections has been raised herein over Wang in view of Earlenbaugh and Wang in view of Earlenbaugh further in view of Hava.
Applicant's arguments filed 07/07/2026 have been fully considered but they are not persuasive.
Applicant argues Wang does not disclose or suggest the claimed method for inhibiting the replication of SARS-CoV-2. Applicant states the reasoning that inhibition of viral entry into cell implies inhibition of replication is logically flawed and asserts the ‘fact that less virus is present in a cell says nothing about the inhibition of replication.’ Applicant asserts Wang provides no expectation that claimed compound would inhibit replication inside already infected cells. Applicant cites “Exhibit A” (Puray-Chavez et al.; Nat. Commun., 2024, 15:8394), which allegedly demonstrates that ACE2 expression level does not correlate with SARS-CoV-2 replication in cells which have already been infected. Applicant admits ACE2 is responsible for viral attachment and cell entry, then argues ACE2 expression ‘does not guarantee robust viral replication’ since post-entry immune checkpoints limit viral replication. Applicant asserts Wang discloses no quantitative measurement of viral load. Applicant further argues one would have no motivation to combine Wang and Hava; and that Wang undermines Examiner’s assumption that the observed activity of extract #45 can be attributed to CBD alone, and asserts the Examiner disregarded the context in which entourage effect is taught. Applicant argues one of ordinary skill would have no expectation that CBD alone would achieve the desired effect. Applicant asserts examiner uses improper hindsight reasoning in their conclusion, since the references cited do not provide the required motivation to contact cells with CBD alone.
As an initial matter, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Furthermore, in response to applicant's arguments against the references individually, 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). The instant rejections are over Wang in view of Earlenbaugh and Wang in view of Earlenbaugh further in view of Hava; thus, Applicant’s arguments against the teachings of Wang alone are not persuasive, since no rejection has been made here over Wang alone.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Wang discloses that it is now well accepted that angiotensin-converting enzyme II (ACE2) is the cell receptor of SARS-CoV-2 and the main route for receptor-mediated entry of the virus into the human host. Since ACE2 plays a pivotal role in cellular entry, ACE2 expressing cells serve as critical viral gateways (for viral replication) (page 2, lines 16-20). Wang teaches that high-cannabidiol (CBD) sativa extracts may be used to modulate ACE2 and TMPRSS2, which are disclosed as critical proteins required for SARS-CoV-2 entry into host cells (abstract). Wang discloses dilution of CBD extracts to about 0.01 mg/mL for their experiments, treating different tissue models with their extract solution (page 3, end of para. 1 and section 2.2).
Earlenbaugh teaches CBD has been shown to increase the production of interferons, a type of signaling protein that activates immune cells and prevents viruses from replicating (page 2, end of para. 2). Earlenbaugh specifically focuses on SARS-CoV-2 and COVID19 in their report.
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to contact a cell with an effective amount of CBD as the sole pharmaceutically active ingredient to inhibit the replication of SARS-CoV-2. One of ordinary skill would have been motivated to do so because Wang discloses CBD sativa extracts may be used to modulate ACE2 and TMPRSS2, which are disclosed as critical proteins required for SARS-CoV-2 entry into host cells; and because Earlenbaugh discloses CBD can help with COVID19, specifically stating that CBD has been shown to increase the production of interferons, a type of signaling protein that activates immune cells and prevents viruses from replicating. One of ordinary skill would have had a reasonable expectation of success in view of the disclosures above.
Furthermore, Hava discloses a method of treating a viral infection, including SARS-CoV (Hava’s claim 5; and [0056] line 8) comprising administration of CBD ([0014], last line of col. 1; and claim 9), thus suggesting a single active ingredient in their formulation. Hava teaches their composition may be in any suitable form, such as a spray (page 24 and [0077], lines 1-5). Hava discloses their composition further comprising a co-therapeutic agent, such as an anti-viral ([0074], lines 1-6). Hava further discloses co-therapeutic agent may be administered before, after, or concurrently with the CBD ([0074], col. 2, top 3 lines, page 7), and teaches co-therapeutic antiviral agents, such as amantadine [0095].
Therefore, it would have been prima facie obvious before the effective filing of the claimed invention to contact a cell with CBD in spray form to inhibit SARS-CoV-2 replication. One of ordinary skill in the art would have been motivated to do so with a reasonable expectation of success because Wang in view of Earlenbaugh disclose a method of inhibiting SARS-CoV-2 replication comprising contacting cells with CBD; and because Hava discloses CBD compositions may be in the form of a spray for treating viral infections. Thus, one of ordinary skill would have been motivated to prepare a spray formulation comprising CBD in a carrier in order to spray cells, thus maximizing efficacy of the contacting of cells with CBD in order to inhibit SARS-CoV-2 replication. One of ordinary skill would have further had a reasonable expectation of success in view of Wang’s disclosure of a CBD composition in DMSO; and Hava’s disclosure of a CBD composition in spray form.
In response to applicant's argument that Wang discloses no quantitative measurement of viral load, the fact that the inventor 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. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
In response to Applicant’s argument that Examiner undermined the teachings of Wang for attributing the effects of extract #45 to CBD alone; Examiner has not undermined any teaching from the prior art, however, the instant rejection is over Wang in view of Earlenbaugh. Earlenbaugh discloses CBD alone inhibits viral replication by producing inteferons, therefore, as taught by Wang in view of Earlenbaugh, it would have been prima facie obvious to one of ordinary skill to contact cells with CBD alone, as outlined in the rejections presented herein.
Furthermore, in response to Applicant’s assertion that inhibition of cell entry into the cell will not inhibit viral replication, Applicant seems to be holding standards of ‘inhibition’ to mean ‘absolute inhibition’ (which absolute inhibition is not even attained in the Experimental results shown in the spec – See for example Table 1, page 16). The broadest reasonable interpretation of the claim, even some inhibition of replication reads on the claim. The claim has been given the broadest reasonable interpretation (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
In response to Applicant’s arguments that Wang provides no motivation or expectation that CBD would inhibit replication inside already infected cells, Applicant seems to have misinterpreted Wang’s disclosure, which states that CBD sativa extracts may be used to modulate ACE2 and TMPRSS2, which are disclosed as critical proteins required for SARS-CoV-2 ENTRY into host cells (abstract) – Thus, in view of Wang and Earlenbaugh, one of ordinary skill would expect limited or no SARS-CoV-2 entry into the cell after contacting with CBD, thus inhibiting viral replication, since the virus will NOT enter the cell and will NOT be able to replicate. Therefore, Applicant’s arguments and presentation of “Exhibit A” – which talks about what happens AFTER virus has entered the cell (see abstract) – is not pertinent to the present discussion. Furthermore, Applicant’s “Exhibit A” admits that interferons (INF’s) “constitute a potent block to SARS-CoV-2 replication” [once inside the cell] (see page 1, col. 1) – Earlenbaugh (cited herein) teaches CBD has been shown to increase the production of interferons, thus further proving the Examiner’s point that the instant claims are obvious in view of the art of record. Thus, in view of Wang and Earlenbaugh, SARS-CoV-2 entry into the cell will be halted by ACE2 and TMPRSS2 modulation by CBD, thus inhibiting replication, AND if any SARS-CoV-2 makes it into the cell, interferons produced after contacting with CBD, as taught by Earlenbaugh and confirmed by Applicant’s Exhibit A, will further block replication.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACKSON J HERNANDEZ whose telephone number is (571)272-5382. The examiner can normally be reached Mon - Thurs 7:30 to 5.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
