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 .
Status of the Claims
Claims 15-22 are pending and examined.
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.
Claim 21 does not fall within at least one of the four categories of patent eligible subject matter because they are naturally occurring compositions of matter.
According to the instant Specification on page 5:
It [CBD] is a major constituent of the Cannabis plant, second to THC, and represents up to 40% in its extracts…CBD can be extracted from various Cannabis plant species including Cannabis sativa, indica and ruderalis…According to one embodiment, is provided a CBD of natural origin, that is extracted from Cannabis strains variety.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural products without significantly more.
Claim 21 recites CBD, which is present in a natural plant with a known and common carrier, ethanol at a low dosage of 0.5%. There is no indication that the composition has any characteristics that are markedly different from the naturally occurring counterpart. The claims do not, therefore, include additional elements that are sufficient to amount to significantly more than the judicial exception.
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product; thus, the answer to Step 1 is Yes.
The analysis then moves to Step 2A, Prong One, which asks if a claim recites to a product of nature. In this case, instant claims are directed to dosage form comprising CBD which can be found in nature, and therefore patent ineligible judicial exceptions (natural products) under 35 USC 101.
MPEP § 2106.04(b) states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”
MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”.
With respect to the inclusion of ethanol and any carrier, diluent or excipient, there is no indication that instant claimed CBD when incorporated with small amounts of known carriers, will have a function or characteristic that alters the CBD in any marked way in comparison with the closest naturally occurring counterpart from natural plant. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. The additional element is a concentration or amount of a naturally occurring form is not sufficient, per se, to integrate the judicial exception into a practical application. Thus, the answer to Step 2A, Prong Two, is No.
Thus, the analysis must move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” Instant claim 21 recites additional elements such as “diluents or excipient”. However, the pharmaceutical excipients can be anything that does nothing more than slightly dilute the natural product. Claim 22 recites the form of an oil, which is distinct from the form in which CBD occurs in nature and this form allows for topical application to the skin, e.g. Claim 22 is not included in this rejection for that reason. Thus, the answer to Step 2B is No.
As elaborated above, claim 21 does not provide sufficient limitation beyond the judicial exceptions or provide anything that adds significantly more to the judicial exceptions. Consequently, it is not directed to patent eligible subject matter.
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)(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.
Claims 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Hemptouch, "CBD balm for mosquito bites," (posted by admin on November 7, 2018), https://www.hemptouch.com/blog/cbd-balm-for-mosquito-bites/?srsltid=AfmBOor0bG2D9Uq_L2cSczSjaxvA8QqkrcqjJv3V9kWcDe68kaq3Y0uU- date accessed September 9, 2025.
The “hemptouch” article was lasted updated on January 7, 2020. It teaches topical CBD will calm itching, irritation, and reduce local inflammation that results from a mosquito bite. The itching that occurs is a result of inflammation caused by the bite. The administration would have an effect of preventing IBH and a POSA would immediately envisage treating inflammation associated with or caused by an insect bite.
Claims 15-17 are anticipated by the prior art.
Claims 15-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Strange Sounds, "Treating Insect Bites with the Help of CBD: All You Need to Know," June 19, 2020, https://strangesounds.org/2020/06/treat-insect-bites-stings-with-cbd.html- date accessed September 9, 2025.
The “Strange Sounds” article teaches treating insect bites and stings with CBD. The anti-inflammatory properties will reduce swelling, itchiness, and redness of the skin. It can also alleviate pain caused by insect bites. The administration would have an effect of preventing IBH and a POSA would immediately envisage treating inflammation associated with or caused by an insect bite.
Claims 15-17 are anticipated by the prior art.
Claims 15-17 and 20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Palaio, (US2020/0376156) (cited in ISR).
Palaio teaches treating epidermal wounds by applying a composition comprising CBD. See Abstract. A pharmaceutically acceptable carrier can be used including vegetable oils, such as olive oil. See par. 43. The composition can be in the form of an oil. See par. 61. The wound can be an epidermal wound which broadly refers to any injury to the skin that results in damage. It can be damage to an outer layer or inner layer. See par. 44. Examples include burns, ulcers, blisters, psoriasis wounds, sores, and wounds resulting from insect bites. Treating insect bites is claimed in prior art claim 3. An amount of CBD can range from 0.5% to 10% wt. See par. 7. Carriers, diluents, solvents, and vehicles are contemplated for use. See par. 43. Ethanol can be used as a carrier, vehicle or co-solvent. See par.’s 37 and 43. The administration would have an effect of preventing IBH and a POSA would immediately envisage treating inflammation associated with or caused by an insect bite.
As such, claims 15-17 and 20 are anticipated by the prior art.
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 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Palaio, (US2020/0376156) (cited in ISR).
Palaio teaches treating epidermal wounds by topically applying a composition comprising CBD. See Abstract. A pharmaceutically acceptable carrier can be used including vegetable oils, such as olive oil. See par. 43. The composition can be in the form of an oil. See par. 61. The wound can be an epidermal wound which broadly refers to any injury to the skin that results in damage. It can be damage to an outer layer or inner layer. See par. 44. Examples include burns, ulcers, blisters, psoriasis wounds, sores, and wounds resulting from insect bites. Treating insect bites is claimed in prior art claim 3. An amount of CBD can range from 0.5% to 10% wt. See par. 7. Carriers, diluents, solvents, and vehicles are contemplated for use. See par. 43. Ethanol can be used as a carrier, vehicle or co-solvent. See par.’s 37 and 43.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
It would have been prima facie obvious prior to the filing of the instant application to arrive at the claimed methods and products in view of the teachings of the cited prior art. One would be motivated to do so because administering the claimed API in a composition with innumerable excipients, including ethanol, is contemplated. Further such administration is known to alleviate wounds resulting from insect bites. The treatment of other wounds is also contemplated and the treatment of insect bites is claimed. Moreover, a similar dosage and concentration is taught and would be optimized based on their known result-effective nature. Overall, the use of topical CBD to treat a wound resulting from an insect bite is taught. There is no reason that treating and/or preventing IBH would not be treated in the same manner with a reasonable and predictable expectation of success.
Claims 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Palaio, (US2020/0376156) (cited in ISR), in view of Bevier (US2013/0011484).
Palaio teaches treating epidermal wounds by applying a composition comprising CBD. See Abstract. A pharmaceutically acceptable carrier can be used including vegetable oils, such as olive oil. See par. 43. The composition can be in the form of an oil. See par. 61. The wound can be an epidermal wound which broadly refers to any injury to the skin that results in damage. It can be damage to an outer layer or inner layer. See par. 44. Examples include burns, ulcers, blisters, psoriasis wounds, sores, and wounds resulting from insect bites. Treating insect bites is claimed in prior art claim 3. An amount of CBD can range from 0.5% to 10% wt. See par. 7. Carriers, diluents, solvents, and vehicles are contemplated for use. See par. 43. Ethanol can be used as a carrier, vehicle or co-solvent. See par.’s 37 and 43.
Moreover, Bevier teaches applying compositions topically for treating hair loss, hypersensitivity, and inflammatory disorders, among others. See par. 132. The compositions comprise CBD as a preferred component as shown in examples. See par. 206.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
It would have been prima facie obvious prior to the filing of the instant application to arrive at the claimed methods and products in view of the teachings of the cited prior art. One would be motivated to do so because administering the claimed API in a composition with innumerable excipients, including ethanol, is contemplated. Further such administration is known to alleviate wounds resulting from insect bites. The treatment of other wounds is also contemplated and the treatment of insect bites is claimed. Moreover, a similar dosage and concentration is taught and would be optimized based on their known result-effective nature. Overall, the use of topical CBD to treat a wound resulting from an insect bite is taught. There is no reason that treating and/or preventing IBH would not be treated in the same manner with a reasonable and predictable expectation of success. Even further, Bevier teaches treating hair loss, hypersensitivity, and inflammatory disorders with CBD and these are symptoms associated with IBH per dependent claim 17.
Claims 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Torsteinsdottir et al., “A prospective study on insect bite hypersensitivity in horses exported from Iceland into Switzerland,” Acta Vet Scand (2018) 60:69, in view of Small-Howard et al., (US2018/0221304), and in view of Palaio, (US2020/0376156) (cited in ISR).
Torsteinsdottir teaches insect bite hypersensitivity (IBH) in horses is a chronic recurrent seasonal dermatitis. See p2, 1st par. Several studies have shown that IBH is an IgE-mediated, type I hypersensitivity reaction. See p2, 3rd par. In other words, producing IgE antibodies in response to environmental antigens results in type I hypersensitivity diseases.
Small-Howard teaches cannabidiol (CBD) can be used to treat dermatitis, immune disorders, allergy, and others. See Abstract. The active ingredient can be CBD and this can be used to treat conditions and immune disorders in response to a dermal sting or anaphylactic stimulus, inflammation or allergy, among others. See prior art claim 49. Moreover, the immune disorder can be a condition involving hyperactivation of IgE. See par. 47 and prior art claim 67.
Torsteinsdottir and Small-Howard do not teach excipients, form, and amount.
Palaio teaches treating epidermal wounds by applying a composition comprising CBD. See Abstract. A pharmaceutically acceptable carrier can be used including vegetable oils, such as olive oil. See par. 43. The composition can be in the form of an oil. See par. 61. The wound can be an epidermal wound which broadly refers to any injury to the skin that results in damage. It can be damage to an outer layer or inner layer. See par. 44. Examples include burns, ulcers, blisters, psoriasis wounds, sores, and wounds resulting from insect bites. Treating insect bites is claimed in prior art claim 3. An amount of CBD can range from 0.5% to 10% wt. See par. 7. Carriers, diluents, solvents, and vehicles are contemplated for use. See par. 43. Ethanol can be used as a carrier, vehicle or co-solvent. See par.’s 37 and 43.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985); and Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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).
It would have been prima facie obvious prior to the filing of the instant application to arrive at the claimed methods and products in view of the teachings of the cited prior art. One would be motivated to do so because administering the claimed API in a composition with innumerable excipients, including ethanol, is contemplated for treating wounds associated with insect bites. Further, CBD is taught to treat conditions and immune disorders in response to a dermal sting or anaphylactic stimulus, inflammation or allergy, among others. This includes those conditions in which the immune disorder involves hyperactivation of IgE. IBH is taught to be IgE-mediated, type I hypersensitivity reaction. Thus, there is a reasonable and predictable expectation of success in treating insect wounds and bites with CBD, including IBH because CBD mitigates IgE associated inflammatory response and IBH is known to include hyperactivated IgE.
As such, no claim is allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JARED D BARSKY whose telephone number is (571)272-2795. The examiner can normally be reached on 9-5 M-F.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628