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 .
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 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.
Previous Rejections
Applicant’s arguments, filed April 1, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claim 14 is newly added.
Claims 2-3, 5, and 7-9 are canceled.
Claims 1, 4, 6, and 10-14 are pending and are examined on the merits in this prosecution.
CLAIM REJECTIONS
Failure to further limit a previous claim
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.
Claim 13 is rejected under 35 U.S.C. 112(d) 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.
Claim 13 recites the term “A method for delivering a cannabinoid to a subject, wherein said method comprises administering to the nasal cavity of the subject a composition of claim 1.” However, claim 1 is limited to two specific cannabinoids, cannabidiol and cannabinol, not the entire class of cannabinoid compounds. As such, claim 13 expands the compounds administered by the method to compounds not claimed in claim 1.
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.
Obviousness Rejections
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.
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 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.
1) Claims 1, 4, 6, and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Toutounghi (US 2007/0286813 A1; of record), in view of Wermeling (US 2007/0060639 A1; of record), Holladay (US 8,535,728; of record), Aakerman (JP 2012193159 (A); citations below from the machine translation provided by EPO; each citation of record), and Bernstein (US 8,900,643; of record).
Toutounghi teaches a nasal formulation for the treatment and prophylaxis of nasal congestion due to inflammation (Abstract and pg 1, [0026]-[0029] and [0032]). Toutounghi teaches the composition can contain a plant extract such as an essential oil that is a natural antifungal agent such as eucalyptus oil (pg 1, [0032]), reading on claim 1. Toutounghi teaches the composition can contain colloidal silver (pg 2, [0032]).
For claim 10, Toutounghi teaches a nasal inert carrier (pg 1, [0030]).
Toutounghi does not teach cannabinol, cannabidiol, or a capsaicin, and teaches eucalyptus oil and colloidal silver in a laundry list fashion.
Wermeling, Holladay, Aakerman, and Bernstein teach the missing elements of Toutounghi.
Wermeling teaches a composition for intranasal administration comprising a tricyclic cannabinoid for treatment of inflammatory conditions (Abstract; pg 6, [0066]). Wermeling teaches cannabinol as a tricyclic cannabinoid that may be present in the composition (pg 2, [0028]), as well as presence in the composition of the non-tricyclic cannabinoid cannabinol (pg 3, [0031]).
Holladay teaches a silver colloid (col 31: 24-29) composition comprising silver particles and water, wherein the particles comprise an interior of elemental silver and an exterior of ionic silver oxide (Abstract). Holladay teaches silver can provide an anti-inflammatory effect (col 1: 37-39). The particles are present in an amount of about 5-40 ppm (Abstract), calculated by the Examiner as from 0.0005% to 0.004%, overlapping or within the recited range of claim 4. Holladay teaches the silver particles are useful for treating sinus infections and sinusitis (col 29, last line of the table and col 30, first line of the table).
Aakerman teaches a nasal spray comprising eucalyptus oil for the treatment of nasal inflammation (Abstract). Aakerman teaches eucalyptus oil contains 80% of the compound “cineol” (pg 5, [0015]), an alternative name for eucalyptol. Aakerman teaches a cineol content of preferably 200 mg or less per 10 ml of nasal spray solution (pg 5, [0017]); as calculated by the Examiner, the preferred amount of eucalyptus oil is therefore 250 mg or less per 10 ml of nasal spray, or 2.5% or less, overlapping the range claimed in claim 6.
Bernstein teaches a composition for intranasal application of capsaicin is effective for the treatment of inflammatory diseases of the nasal mucosa (rhinitis) through activation of the TRPV1 receptor, which leads to desensitization of nasal sensory neural fibers and reduction in nasal hyperresponsiveness. (Abstract; col 3: 9-35).
The Examiner interprets the “pharmaceutically-acceptable carrier” limitation of claim 14 to include all carriers and/or excipients as set forth in the instant Specification (page 9: 29 to page 10: 17):
Carriers and/or excipients according the present invention can include any and all solvents, diluents, buffers (e.g., neutral buffered saline, phosphate buffered saline, or optionally Tris-HCl, acetate or phosphate buffers), oil-in-water or water-in-oil emulsions, aqueous compositions with or without inclusion of organic co-solvents suitable for, e.g., IV use, solubilizers (e.g., Tween 80, Polysorbate 80), colloids, dispersion media, vehicles, fillers, chelating agents (e.g., EDTA or glutathione), amino acids (e.g., glycine), proteins, disintegrants, binders, lubricants, wetting agents, emulsifiers, sweeteners, colorants, flavorings, aromatizers, thickeners, coatings, preservatives ( e.g., Thimerosal, benzyl alcohol), antioxidants (e.g., ascorbic acid, sodium metabisulfite), tonicity controlling agents, absorption delaying agents, adjuvants, bulking agents (e.g., lactose, mannitol), and the like.
In some cases, the carriers can be, for example, sterile or non-sterile aqueous or non-aqueous solutions, suspensions, and emulsions. Examples of non-aqueous solvents include, without limitation, propylene glycol, polyethylene glycol, vegetable oils, and organic esters. Aqueous carriers include, without limitation, water, alcohol, saline, and buffered solutions. Acceptable carriers also can include physiologically acceptable aqueous vehicles (e.g., physiological saline) or other known carriers appropriate to specific routes of administration. The use of carriers and/or excipients in the field of drugs and supplements is well known. Except for any conventional media or agent that is incompatible with the supplement composition or with, its use in the present compositions may be contemplated.
Regarding newly added claim 14, Toutounghi teaches a nasally administered composition containing eucalyptus oil ([0032]) in an inert carrier ( [0030]) to reduce nasal inflammation; Wermeling teaches nasally administered cannabidiol and cannabinol in a carrier for the treatment of nasal inflammation (pg 5, 0056]); Holladay teaches colloidal silver in an inert carrier (propylene glycol/water) for nasal inflammation (col 1: 37-39; col 19: 54-61); Aakerman teaches eucalyptus oil for nasal inflammation (see citation above); and Bernstein teaches capsaicin for nasal inflammation (see citation above).
For limitation of a method for delivery recited in claim 13, the combination of Toutounghi, Wermeling, Holladay, Aakerman, and Bernstein teach a method for delivering cannabinol and cannabidiol, silver, eucalyptus oil, and capsaicin since Toutounghi teaches a nasal formulation for the treatment and prophylaxis of nasal congestion due to inflammation, Wermeling teaches a nasal formulation comprising a tricyclic cannabinoid for treatment of inflammatory conditions, Holladay teaches colloidal silver particles are useful for treating sinus infections and sinusitis, Aakerman teaches a nasal spray comprising eucalyptus oil for the treatment of nasal inflammation, and Bernstein teaches capsaicin applied intranasally is effective in treating inflammation of the nasal mucosa by activation of the TRPV1 pathway.
It would have been obvious to one of ordinary skill in the art before the effective filing date on the claimed invention to utilize the nasal formulation comprising silver and eucalyptus oil, as taught by Toutounghi, modified to further comprise cannabinol, cannabidiol, and capsaicin. A person of ordinary skill would have been motivated to choose the nasal formulation taught by Toutounghi comprising silver and eucalyptus oil, and supplement the formulation with cannabidiol, cannabinol, and capsaicin, since Wermeling teaches a nasal formulation comprising comprise cannabinol and cannabidiol is useful as a treatment of inflammatory conditions; Holladay teaches colloidal silver particles are useful for treating sinus inflammation such as sinusitis; Aakerman teaches a nasal spray comprising eucalyptus oil for the treatment of nasal inflammation; and Bernstein teaches capsaicin applied intranasally is effective in treating inflammation of the nasal mucosa by activation of the TRPV1 pathway, a pathway not taught by the prior art of Toutounghi, Wermeling, Holladay, and Aakerman because, as set forth in MPEP 2144.07, it is prima facie obvious to select a known material for incorporation into a composition, based on its art-recognized suitability for its intended use.
3) Claims 11 and 12 are rejected in view of Toutounghi (cited above), in view of Wermeling (cited above), Holladay (cited above), Aakerman (cited above), Bernstein (cited above), and Goskonda (US 8,222,292; of record).
The teachings of Toutounghi, Wermeling, Holladay, Aakerman, and Bernstein are discussed above.
The combination of Toutounghi, Wermeling, Holladay, Aakerman, and Bernstein does not recite a composition comprising a surfactant such as a fatty acid.
Goskonda teaches the missing element of the combination of Toutounghi, Wermeling, Holladay, Aakerman, and Bernstein.
Goskonda teaches oral, transmucosal, or nasogastric preparations comprising cannabinoids comprising a free fatty acid such as oleic acid or linoleic acid as an absorption enhance (Abstract; col 2: 27-31; col 14: 27-32; col 11:4).
It would have been obvious to one of ordinary skill in the art before the effective filing date on the claimed invention to include a fatty acid in the nasal formulation taught by the combination of Toutounghi, Wermeling, Holladay, Aakerman, and Bernstein. One of ordinary skill in the art would be motivated to add a fatty acid to the composition of the combination of Toutounghi, Wermeling, Holladay, Aakerman, and Bernstein since Goskonda teaches that oleic acid or linoleic acid can be added to increase absorption and thus increase bioavailability of the cannabinoid, and, generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Furthermore, as set forth in MPEP 2144(IV):
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention);
As such, the addition of a fatty acid to the composition taught by the combination of Toutounghi, Wermeling, Holladay, Aakerman, and Bernstein would read on claims 11 and 12 in view of Goskonda’s teaching of the addition of a fatty acid as an absorption enhancer.
Examiner’s Reply to Attorney Arguments dated 4/1/2026
1. Rejection of claims 1-8, 10 and 13 under 35 U.S.C. §103 over Toutounghi, Wermeling, Holladay, and Aakerman.
The applicant argues the cited references do not disclose the very specific advantageous formulation now claimed wherein the composition comprises, or consists of, cannabinol; cannabidiol; silver; eucalyptus oil; and capsaicin. The applicant argues the prior art does not suggest the “desirability” of the composition.
The Examiner acknowledges the arguments presented, but does not consider them persuasive. The references cited by the Examiner in the rejection each provide for nasal administration of one or more claimed ingredients for the specific purpose of reducing inflammation. As set forth in MPEP 2144.06, it is prima facie obvious to combine equivalents known for the same purpose (as per In re Kerkhoven). Further, as discussed in MPEP 2144.07, “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness.”
The applicant also argues that the prior art must suggest the “desirability” of the composition, citing In re Gordon. Gordon is discussed in MPEP 2143.01 (“If a proposed modification would render the prior art invention being modified unsatisfactory for its intended purpose, there may be no suggestion or motivation to make the proposed modification.” In re Gordon, 733 F.2d 900, 221 USPQ 1125 (Fed. Cir. 1984)). In the instant case, the proposed modifications to Toutounghi of cannabinol, cannabidiol, and capsaicin by the prior art of Wermeling, Holladay, Aakerman, and Bernstein, as discussed above, are prima facie obvious to add as per MPEP 2144.06 and 2144.07) since they are known equivalents to the silver and eucalyptus oil taught in Toutounghi since they are known nasally administered anti-inflammatories. Furthermore, applicant has failed to explain the relevancy of the Gordon’s invention (a blood filter assembly used during surgery and other procedures involving the handling of blood to remove clots, bone debris, tissue, or other foreign materials from blood before it is returned to a patient's body)” to the claimed “composition for application in the nasal cavity of a subject” comprising cannabinol, cannabidiol, silver, eucalyptus oil, and capsaicin.
3. Rejection of claims 11 and 12 under 35 U.S.C. §103 over Toutounghi, Wermeling, Holladay, Aakerman, and Goskonda.
The applicant alleges the cited primary references do not provide the skilled artisan with any motivation to arrive at the specific composition as currently claimed, and further alleges that the addition of the Goskonda reference does not cure the deficiencies of the primary references.
The Examiner acknowledges the argument presented, but does not consider it persuasive. As discussed above, it is the position of the Examiner that claim 1 is properly rejected and the motivation for combining the cited references is clearly supported by the case law cited in MPEP 2144.06 and 2144.07. As such, the rejection of claims 11 and 12 is maintained over the cited prior art of Toutounghi, Wermeling, Holladay, Aakerman, Bernstein, and Goskonda.
CONCLUSION
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL P COHEN whose telephone number is (571)270-7402. The examiner can normally be reached on M-Th 8:30-5:30; F 9-4.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup, can be reached on (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL P COHEN/Primary Examiner, Art Unit 1612
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