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 .
Priority
This application is a 371 of PCT/CA2020/051326 10/02/2020 which claims foreign priority to CANADA 3057647 10/03/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 3057647, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior filed application fails to provide support for:
the claimed range of linalool with a lower limit of 25 mg/mL and an upper limit of 500 mg/mL, required in claim 4 and claim 10;
the claimed oral formulation, required in claim 26; and
wherein the skin condition is vasculopathic ulcers, ulcers and erosions related to diabetes, blistering skin conditions, ulcers and erosions caused by autoimmune diseases; vascultic ulcers and erosions; or ulcers and erosions caused by other complex diseases, required in claim 27.
Thus, the Examiner is interpreting claims 1-3, 5-9, 11-13 and 21-25 have an effective filing date of October 10, 2019 and claims 4, 10 and 26-27 have an effective filing date of October 02, 2020.
Claim Status
The claim set and Applicant’s remarks filed May 27, 2025 have been entered. Claims 14-20 have been canceled. Thus, claims 1-13 and 21-27 as amended are examined on the merits herein.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 05/27/2025, 07/15/2025 and 09/05/2025 have been considered.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on February 24, 2025:
(I) The objections of claims 3, 5-6, 9, 11-12 and 23 are withdrawn in view of Applicant’s amendments which have overcome each and every claim objection as discussed in the non-final office action above.
(II) The rejection of claims 1-5, 7-11, 13, 21-22, and 24-27 under 35 U.S.C. 103;
(III) The rejection of claims 1-13, 21-22, and 24-27 under 35 U.S.C. 103; and
(IV) The rejection of claims 1-5, 7-11, 13 and 21-27 under 35 U.S.C. 103 are each withdrawn in view of Applicant’s amendment to claim 1 and claim 7 including diosmin as a required flavonoid within the composition.
Response to Arguments
(I) The rejection of claims 1-13 under 35 U.S.C. 101 is maintained.
Applicant contends the claimed combination of claim 1 or claim 7, which includes diosmin as a recited flavonoid in claim 1, lines 4-5 and claim 7, line 6; and tetrahydrocannabinolic acid as a recited cannabinoid in claim 1, lines 7-8 and claim 7, line 8, are not found in nature in the claimed amounts, see Applicant’s arguments, pg. 6 of 11, III. Claim Rejections – 35 U.S.C. § 101, paragraph 2.
The Examiner respectfully notes the claims do not require the use of any particular non-conventional reagents. The prior art also demonstrates the well understood, routine, conventional nature of additional elements because it teaches that the additional elements are well known.
The Examiner also respectfully notes the disclosure states the cannabinoid(s) , terpene(s) and flavonoid(s) used in a topical formulation provided herein may be extracted from natural plants (see pg. 16, paragraph [0095], lines 1-2).
Additionally, the Examiner respectfully notes the combination of Eyal, Dellavalle and Boisnic teach a topical composition comprising the recited cannabinoids, terpenes and flavonoids at the recited concentrations of each of those components as required in claims 1-13 as discussed in further detail in the new 103 rejections written below.
Thus, the prior art of Eyal, Dellavalle and Boisnic (e.g. in the obviousness rejections) discussed below further serves as evidence the claimed amounts are not significant, and do not represent an unobvious improvement of what the natural product contains (i.e. treating ulcers and pain as taught by Eyal in the obviousness rejections below).
Thus, Applicant’s arguments have been fully considered but they are not found persuasive.
(II) The rejection of claims 1-5, 7-11, 13, 21-22 and 24-27 under 35 U.S.C. 103;
(III) The rejection of claims 1-13, 21-22 and 24-27 under 35 U.S.C. 103; and
(IV) The rejection of claims 1-5, 7-11, 13, and 21-27 are maintained.
(A) Applicant argues that neither Eyal nor Dellavalle, alone or in combination, disclose or suggest a formulation including diosmin; nor would one of ordinary skill in the art have sought to modify the compositions of Eyal and Dellavalle to include diosmin and one or more additional different flavonoids, see Applicant’s remarks, pg. 7 of 11, IV.a. Eyal and Dellavalle, paragraph 2.
(B) Eyal does not disclose a single possible identity of any flavonoid in any specific embodiments. Indeed none of the 30 examples of Eyal describes the presence of any flavonoid, let alone diosmin as presently claimed, see Applicant’s arguments, pg. 8 of 11, first full paragraph.
(C) Dellavalle does not describe or suggest use of its personal care compositions for use in wound treatment, see pg. 8 of 11, second full paragraph.
(D) Atia is directed to diosmin nanocrystal wafers under lab-scale preparation as highly experimental wherein the diosmin nanocrystals themselves would not be considered safe ingredients or consumer acceptable, see Applicant’s arguments, pg. 9 of 11, second full paragraph.
(E) Micronized diosmin as exemplified in Applicant’s embodiment in Example 2, during treatment, rapid granulation and epithelial growth (FIG. 4) was observed, coupled with a decrease in wound size (FIG. 5). These dramatic wound healing results also suggest a synergistic effect between the cannabinoids, terpenoids, and flavonoids, see pg. 9 of 11, last paragraph – pg. 10 of 11, first paragraph.
With respect to Applicant’s argument (D), Applicant’s argument is found persuasive in view of the amendment to claims 1, 7 and 21 wherein diosmin is added to the topical formulation as recited and required in claims 1, 7 and 21, as Atia teaches diosmin nanocrystal wafers as discussed above.
However, Boisnic teaches a 2% diosmin cream administered topically as discussed in the subsequent arguments below and discussed in further detail in the new 103 rejections below.
With respect to Applicant’s arguments (A)-(C) and (E), Eyal teaches cannabinoid compositions comprising at least one cannabinoid in a specific amount, at least one primary terpene in a specific amount, at least 5% by weight of a non-cannabinoid, non-terpene, carrier, and use of the disclosed compositions in treating conditions and/or symptoms associated with at least one of and including ulcers. Eyal teaches conditions and/or symptoms associated with an ulcer may include local pain.
Eyal teaches the composition comprises at least two flavonoids including quercetin.
Dellavalle teaches personal care compositions comprising a cannabinoid and a terpene and further comprises a flavonoid.
Dellavalle teaches a method of treating, preventing or ameliorating a symptom associated with a disease, disorder, or condition relating to both chronic or acute pain, comprising applying any one of the personal care compositions described by Dellavalle, to the skin of a subject in need thereof.
Boisnic teaches a 2% diosmin cream which exhibited significant vasoconstrictive and anti-inflammatory effects which were not observed in the placebo cream. Boisnic concludes diosmin administered topically may protect skin against the biological effects of various exogenous stress (e.g. pressure), such as chronic venous disease, see pg. 848, abstract, conclusion. Boisnic also teaches chronic venous insufficiency (e.g. the chronic venous disease discussed above) causes various symptoms including pain and ulcerations.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filing date to have included diosmin as taught by Boisinc above into the topical composition as taught by Eyal and Dellavalle above as within the scope of the artisan as combining prior art elements according to known compositions to yield predictable results. One of ordinary skill in the art would have been motivated to treat the ulcers taught by Eyal above, as Dellavalle teaches their personal care products can be used to treat or ameliorate a symptom associated with a condition relating to chronic or acute pain, for example the ulcers taught by Eyal above; and motivated to include diosmin as a skin protecting agent against exogenous stresses, such as pressure ulcers taught by Eyal above; or when associated with chronic venous insufficiency which causes both pain and ulcerations as taught by Boisnic above.
One of ordinary skill in the art would have had a reasonable expectation of success to have included diosmin into the topical composition of Eyal above, as Eyal, Dellavalle and Boisnic are all drawn to topical compositions comprising flavonoids used for therapeutic purposes as discussed above.
Thus, Applicant’s arguments (A)-(C) and (E) have been fully considered but are not found persuasive.
(V) The provisional rejection of claims 1-13, 21-22 and 24-27 on the ground of nonstatutory double patenting; and
(VI) The provisional rejection of claims 1-13 and 21-27 on the ground of nonstatutory double patenting are maintained in view of Applicant’s amendments to claims 1, 7 and 21 and Applicant’s request that these rejections be held in abeyance until the claims are otherwise in condition for allowance.
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.
Claims 1-13 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The 2019 Revised Patent Subject Matter Eligibility Guidance (issued January 7, 2019)” (https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf) and “October 2019 Update: Subject Matter Eligibility (issued October 17, 2019)” (https://www.uspto.gov/sites/default/files/documents/peg_oct_2019_update.pdf), are followed here.
Step 1 asks if a claim is directed to a statutory category of invention. Applicant’s claims are directed to a product. The claims recite "a topical formulation comprising cannabinoids, terpenes, and flavonoids" (a composition of matter, Step 1: Yes).
Step 2A, prong one asks if a claim recites a product of nature. Claims 1 and 7 are directed towards a topical formulation comprising one or more cannabinoids including tetrahydrocannabinolic acid; one or more terpenes, and one or more flavonoids including diosmin. Claims 2 and 8 recite wherein the one or more cannabinoids further comprise cannabidiol or cannabidiolic acid. Claims 3 and 9 recite wherein the one or more terpenes comprise beta-caryophyllene. Claims 4 and 10 recite wherein the one or more terpenes further comprise linalool. Claims 5 and 11 recite wherein the one or more flavonoids further comprise at least one of quercetin and hesperidin. Claims 6 and 12 recite wherein the one or more flavonoids further comprise quercetin. Claims 1 and 13 recite or further recite, a liquid carrier, respectively.
Apart from the liquid carrier, all of the aforementioned compounds are extractable from cannabis, as disclosed in the specification (pg. 12, paragraph [0080], lines 2 and 4 and paragraph [0095], pg. 16, line 27 – pg. 17, line 2).
In addition, claims 1-13 recite "a topical formulation comprising one or more cannabinoids including tetrahydrocannabinolic acid; one or more terpenes, and one or more flavonoids including diosmin", namely naturally occurring compounds found in cannabis plants and also naturally occurring forms. Cannabis contains the presently claimed cannabinoids, combination of terpenes, and combination of flavonoids as disclosed in the Specification (see pg. 16, paragraph [0095], lines 1-2). Applicant’s topical formulation is a mixture of the naturally occurring compounds found in cannabis plants. Thus, the topical formulation is a nature-based product (Step 2A, prong one: Yes).
Step 2A, prong two asks if the claim recites additional elements that integrate the judicial exception into a practical application. There is no indication in the record that isolation of “one or more cannabinoids including tetrahydrocannabinolic acid; one or more terpenes, and one or more flavonoids" have resulted in a marked difference in structure, function or other properties as compared to its counterparts “one or more cannabinoids including tetrahydrocannabinolic acid; one or more terpenes, and one or more flavonoids" extracted from cannabis plants as disclosed above.
In addition, claim 1 recites “a topical formulation”; claim 7 recites “a topical formulation for direct application to an integumentary wound”; and claim 13 recites “ for instillation of the topical formulation onto an integumentary wound”. MPEP § 2106.04(d)(2) specifically states “If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration.”. Therefore applicant’s field of use (e.g. a topical formulation) or intended use (e.g. for direct application to an integumentary wound or for installation onto an integumentary wound) as discussed above is not sufficient to integrate the judicial exception into a practical application. Thus, this is a product of nature exception (Step 2A, prong two: No).
Step 2B asks if claims recite additional elements that amount to significantly more than the judicial exception. In this case, the additional element in the claims is the combination of the cannabinoids, terpenes and flavonoids with a liquid carrier. However, MPEP § 2106.05(d) specifically states “If, however, the additional element (or combination of elements) is no more than well-understood, routine, conventional activities previously known to the industry, which is recited at a high level of generality, then this consideration does not favor eligibility”.
Moreover, Eyal et al. (Filed 13 May 2019, WO-2019220324-A2, PTO-892 mailed 02/24/2025) teaches compositions comprising cannabinoids, see paragraph [0029], terpenes, see paragraph [0030], and flavonoids, see paragraph [00193], with a liquid carrier such as consisting of vegetable oils, see paragraph [00172]; and thus based on the teachings of Eyal combining liquid carriers into a composition comprising cannabinoids, terpenes and flavonoids was well-understood, routine and conventional before the invention was filed. Thus, the recitation of a liquid carrier, at this high level of generality is not sufficient to show that the claims amount to significantly more than the judicial exception. As mixing specific compounds does not amount to significantly more than a combination of the judicial exception because mixing compounds with a known liquid carrier as taught by Eyal above is well-understood, routine, and conventional in the field, Thus, mixing the cannabinoids, terpenes, and flavonoids with a liquid carrier does not amount to significantly more than a combination of the judicial exception because mixing compounds is well-understood, routine and conventional in the field.
In addition, applicant’s intended use of the topical instillate is not considered to amount to significantly more. As discussed in MPEP § 2106.05(I)(A) “Generally linking the use of the judicial exception to a particular technological environment or field of use”, is not considered enough to qualify as significantly more. An intended use of a claimed composition only generally links the exception to the field of use.
Therefore, the additional elements are not considered to amount to significantly more (Step 2B, No).
Thus, the claims are not directed to patent eligible subject matter.
New Claim Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on May 27, 2025, where the limitations in pending claims 1-13 and 21-27 as amended now have been changed. Therefore, rejections from the previous Office Action, dated February 24, 2025, have been modified and are listed below.
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.
The factual inquiries 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.
(I) Claims 1-13, 21-22, and 24-27 are rejected under 35 U.S.C. 103 as being unpatentable over Eyal et al. (Filed 13 May 2019, WO-2019220324-A2, PTO-892 mailed 02/24/2025) in view of Dellavalle et al. (Published 11 July 2019, WO-2019136351-A1, PTO-892 mailed 02/24/2025) and Boisnic et al. (Published 10 September 2018, Journal of Cosmetic Dermatology, Vol. 17, Issue 5, pp. 848-854, PTO-892).
Regarding claims 1-13, 21-22, and 24-27, Eyal teaches cannabinoid compositions comprising at least one cannabinoid in a specific amount, at least one primary terpene in a specific amount, at least 5% by weight of a non-cannabinoid, non-terpene, carrier, and use of the disclosed compositions in treating conditions and/or symptoms associated with at least one of and including ulcers, see abstract.
Eyal teaches the carrier is selected from the group consisting of and including vegetable oils, e.g. coconut oil, olive oil or sesame oil (e.g. a liquid carrier, required in claim 1 and claim 13).
Eyal teaches the at least one cannabinoid is selected from the group consisting of and including CBD (where Eyal defines CBD to refer to CBDa (cannabidiolic acid) and/or to CBD (cannabidiol), see paragraph [00149]), and THC (where Eyal defines THC to refer to THCa (tetrahydrocannabiniolic acid, e.g. required in claim 1 and claim 7, and/or to THC (tetrahydrocannabiniol), see paragraph [00149]) and combinations thereof; the at least one primary terpene is selected from the group consisting of and including linalool and caryophyllene (e.g. beta-caryophyllene, required in claims 3 and 9), and the conditions and/or symptoms comprise ulcer, optionally pressure ulcer and/or diabetic ulcer (e.g. ulcers and erosions related to diabetes, required in claim 27), see paragraph [0036]. Eyal teaches conditions and/or symptoms associated with an ulcer may include local pain, see paragraph [005].
Eyal teaches the composition comprises at least two flavonoids including quercetin, see paragraph [00193].
Eyal teaches the composition is administered topically (e.g. applying a first topical formulation, required in claim 21), see paragraph [00241].
Eyal teaches administering a first composition (e.g. a first topical formulation, required in claim 21) comprising a cannabinoid and a first primary terpene followed by administering to a subject a second composition (e.g. a second topical formulation, required in claim 22) comprising the first cannabinoid and a secondary primary terpene, see paragraph [0086].
Eyal teaches the composition is for administration as a mouthwash (e.g. an oral formulation, required in claim 26), see paragraph [00207].
Eyal teaches the composition is a liquid, see paragraph [00195]; and that terpenes form at least 20% by weight of the composition, see paragraph [00184].
Eyal teaches the composition comprises tetrahydrocannabinol (THC) and/or tetrahydrocannabinolic acid (THCa), wherein THC and/or THCa is in a total concentration of at least 1% by weight, see paragraph [00187]; the composition comprises cannabidiol (CBD) and/or cannabidiolic acid (CBDa), wherein CBD and/or CBDa is in a total concentration of at least 1% by weight, see paragraph [00188].
Based on a 20% by weight of terpenes in the composition of the liquid as taught by Eyal above that would result in 200 mg/mL of terpenes within the liquid composition.
Additionally, based on the 1% by weight of THC, THCa, CBD, and CBDa as taught by Eyal above, that would result in 10 mg/mL of THC and/or THCa; and 10 mg/mL of CBD and/or CBDa in the liquid composition, where both the range of terpenes and cannabinoids taught by Eyal above would correspond to the range of one or more terpenes and one or more cannabinoids, required in claim 1, claim 7, and claim 21; and the range of terpenes, (a) beta-caryophyllene, required in claims 3 and 9; and (b) linalool, required in claims 4 and 10.
Although, Eyal does not teach flavonoids, wherein the flavonoids comprise diosmin, required in claim 1, line 5; claim 7, line 6 and claim 21, lines 4-5.
However, in the same field of endeavor of topical compositions, Dellavalle teaches personal care compositions comprising a cannabinoid and a terpene, see abstract; and further comprises a flavonoid, see paragraph [0024]; by applying the composition to the skin of a subject, see paragraph [0011].
Dellavalle teaches personal care compositions further comprising a flavonoid, see paragraph [0024]. Dellavalle teaches personal care compositions comprising from about 1 wt.% to about 5 wt.% of a flavonoid, based on the total weight of the composition, see paragraph [0042]. Dellavalle teaches personal care compositions are in the form selected from and including a liquid, a solution and a cream, see paragraph [0046].
Based on the about 1% to about 5% by weight of flavonoids in the composition of the liquid as taught by Dellavalle above that would result in a range of flavonoids between 10-50 mg/mL.
Dellavalle teaches a method of treating, preventing or ameliorating a symptom associated with a disease, disorder, or condition relating to both chronic or acute pain, comprising applying any one of the personal care compositions described herein, to the skin of a subject in need thereof, see paragraph [0075].
Additionally, Boisnic teaches a 2% diosmin cream exhibited significant vasoconstrictive and anti-inflammatory effects which were not observed in the placebo cream, see pg. 848, abstract, results.
Boisnic concludes diosmin administered topically may protect skin against the biological effects of various exogenous stress (e.g. pressure), such as chronic venous disease, see pg. 848, abstract, conclusion. Boisnic also teaches chronic venous insufficiency causes various symptoms including pain and ulcerations, see pg. 848, introduction, paragraph 1.
The Examiner notes a 2% diosmin cream as taught by Boisnic above would contain 20 mg/mL of diosmin.
Therefore, the Examiner respectfully notes if quercetin taught by Eyal above is present at 1% by weight and the diosmin is present at 2% by weight as taught by Boisnic above, the total amount of flavonoids within the composition, which Eyal teaches contains at least two flavonoids, is 30 mg/mL and corresponds to the amount of flavonoids recited in claim 1, lines 4-5 and claim 7, lines 5-6.
It would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filing date to have included diosmin within the topical composition taught by Eyal above as within the scope of the artisan as combining prior art elements according to known compositions to yield predictable results. One of ordinary skill in the art would have been motivated to treat the ulcers taught by Eyal above, as Dellavalle teaches their personal care products can be used to treat or ameliorate a symptom associated with a condition relating to chronic or acute pain, for example the ulcers taught by Eyal above; and motivated to include diosmin as a skin protecting agent against exogenous stresses, such as pressure ulcers taught by Eyal; or associated with chronic venous insufficiency which causes both pain and ulcerations as taught by Boisnic above.
One of ordinary skill in the art would have had a reasonable expectation of success to have included diosmin into the topical composition of Eyal above, as Eyal, Dellavalle and Boisnic are all drawn to topical compositions comprising flavonoids used for therapeutic purposes as discussed above.
With respect to the limitation “onto a periwound area around the integumentary wound”, required in claim 22; the Examiner is interpreting this limitation as a physical limitation that is met as the combination of Eyal, Dellavalle and Boisnic teach topically administering a composition meeting all structural components of cannabinoids, terpenes and flavonoids as required in claim 21, from which claim 22 depends; wherein the topically administered composition of Eyal is used in treating conditions and/or symptoms associated with at least one of and including an ulcer, particularly pressure or diabetic ulcers, as discussed above. Therefore, the Examiner reasonably interprets this physical limitation will be met by the combined teachings of Eyal, Dellavalle and Boisinc as discussed above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included diosmin into the compositions and method as taught by Eyal above as within the scope of the artisan as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to treat the ulcers of Eyal with the topical compositions as taught by Eyal above. One of ordinary skill in the art would have had a reasonable expectation of success to have included diosmin into the compositions and methods as taught by Eyal above, as Eyal, Dellavalle and Boisnic are all drawn to topical personal care compositions comprising flavonoids used for therapeutic purposes as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
(II) Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Eyal et al. (Filed 13 May 2019, WO-2019220324-A2, PTO-892 mailed 02/24/2025), Dellavalle et al. (Published 11 July 2019, WO-2019136351-A1, PTO-892 mailed 02/24/2025) and Boisnic et al. (Published 10 September 2018, Journal of Cosmetic Dermatology, Vol. 17, Issue 5, pp. 848-854, PTO-892) as applied to claims 1-13, 21-22, and 24-27 above, and further in view of Lazar (Filed 01 August 2019, WO-2020024056-A1, PTO-892 mailed 02/24/2025).
Eyal, Dellavalle and Boisnic address claims 1-13, 21-22, and 24-27 as written above. Although, Eyal does not teach wherein (a) the first topical formulation further comprise an aloe vera gel and a hyaluronic acid gel, required in claim 23; and (b) the second topical formulation further comprise a transdermal base comprising a liposomal component, required in claim 23.
However, in the same field of endeavor of compositions comprising cannabinoids, with respect to limitations (a)-(b), Lazar teaches a composition for topical administration or for oral administration, see abstract. Lazar teaches the composition is administered in a manner selected from the group consisting of and including transdermal (e.g. a transdermal base required in limitation (b), claim 23), see paragraph [0085]. Lazar teaches the compositions are formulated and/or prepared for topical administration or topical application; the compositions suitable for topical application may be in the form of a gel; they may also be prepared so as to comprise nanosized materials such as liposomes (e.g. the liposomal component, required in limitation (b), claim 23), see paragraph [0096].
Lazar teaches nanosized materials are often used as skin penetrating enhancers, as they are reported to enhance skin penetration compared to larger particles, and are more likely to penetrate the stratum corneum, see paragraph [0096].
Lazar teaches the compositions are used in a method for reducing pain, see paragraph [00112].
Lazar teaches a composition comprising at least one cannabinoid, at least one absorbable material, at least one terpene, and at least one botanical extract; wherein the at least one cannabinoid is isolated from Cannabis; and the at least one absorbable material is a glycosaminoglycan, such as, hyaluronic acid, see paragraph [0012].
Lazar teaches the composition can further include a humectant, which can elevate the hydration of the skin, in particular the epidermis and dermis, and suitable humectants can be for example aloe vera and hyaluronic acid (e.g. the aloe vera gel or hyaluronic acid gel, required in claim 23, line 2), see paragraph [0072].
It would have been prima facie obvious to one of ordinary skill in the art at the invention’s effective filing date to have included limitations (a)-(b) within the topical composition as taught by Eyal above as within the scope of the artisan as combining prior art elements according to known compositions to yield predictable results. One of ordinary skill in the art would have been motivated to treat the ulcers which include local pain as a symptom as taught by Eyal above; as Lazar is drawn to a topical composition comprising at least one cannabinoid for use in reducing pain as discussed above. One of ordinary skill in the art would have had a reasonable expectation of success to have included limitations (a)-(b) into the topical composition of Eyal above, as Eyal and Lazar are both drawn to topical compositions comprising cannabinoids for treating pain as discussed above.
With respect to the first topical formulation, required in limitation (a), claim 23; and the second topical formulation, required in limitation (b), claim 23; the Examiner reasonably interprets these limitations as physical limitations that are met as the combination of Eyal and Lazar teach all structural components recited in the first and second topical formulations, both Eyal and Lazar teach there compositions are formulated as topical compositions; and Eyal teaches administering multiple compositions as described above. Thus, based on the combined teachings of Lazar and Eyal the physical limitations of the first and second topical formulations will be met.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included limitations (a)-(b) into the compositions and methods as taught by Eyal above as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to treat the symptom of local pain associated with an ulcer as taught by Eyal above; by using the liposomes as a skin penetrating enhancer and the aloe vera and hyaluronic acid as skin hydrating agents as taught by Lazar above. One of ordinary skill in the art would have had a reasonable expectation of success to have included limitations (a)-(b) as taught by Lazar above into the compositions and methods as taught by Eyal above, as both Lazar and Eyal are drawn to topical compositions comprising cannabinoids used for treating pain.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(I) Claims 1-13, 21-22 and 24-27 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 23, 25 and 30 of copending Application No. 17/043,068 (Applicant: Vinsan Therapeutics Inc., claim set filed 04/23/2025) in view of Eyal et al. (Filed 13 May 2019, WO-2019220324-A2, PTO-892 mailed 02/24/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compositions comprising one or more cannabinoids, one or more terpenes, one or more flavonoids and a liquid carrier; and methods of their use.
Reference claim 1 recites a topical instillate comprising (a) 0.1 mg/ml to 40 mg/ml of one or more cannabinoids, (b) 25 mg/ml to 1000 mg/ml of one or more terpenes, including at least 10 mg/ml linalool and one or more additional different terpenes; (c) 10 mg/ml to 500 mg/ml of flavonoids, including at least 2 mg/ml hesperidin and one or more additional different flavonoids; and (d) a liquid carrier selected for instillation of the instillate onto an integumentary wound.
Reference claim 4 recites the topical instillate of reference claim 1, wherein the one or more additional flavonoids includes at least one of diosmin and quercetin.
Reference claim 23 recites the topical instillate of reference claim 1, wherein the liquid carrier comprises an aloe vera gel and a hyaluronic gel.
Reference claim 30 recites the topical instillate of reference claim 1, is in the form of an oral application to an integumentary wound or a mucous membrane wound.
Reference claim 5 recites a topical formulation for direct application to an integumentary wound, comprising (a) 0.1 mg/ml to 40 mg/ml of one or more cannabinoids, (b) 25 mg/ml to 1000 mg/ml of one or more terpenes, including at least 10 mg/ml of linalool and one or more additional different terpenes; (c) 10 mg/ml to 500 mg/ml of flavonoids, including at least 2 mg/ml hesperidin and one or more additional different flavonoids.
Reference claim 8 recites the topical formulation of claim 5, wherein the one or more additional flavonoids includes diosmin and quercetin.
Reference claim 25 recites the formulation of reference claim 9, wherein the liquid carrier comprises an aloe vera gel and a hyaluronic gel.
Reference claim 2 corresponds to limitations of instant claim 2.
Reference claim 3 corresponds to limitations of instant claim 3.
Reference claim 6 corresponds to limitations of instant claim 8.
Reference claim 7 corresponds to limitations of instant claim 9.
Reference claim 9 corresponds to limitations of instant claim 13.
Although, ‘068 does not teach (a) wherein the cannabinoids comprise at least 0.1 mg/ml tetrahydrocannabinolic acid, required in instant claims 1, 7, and 21; (b) a method of treating an integumentary wound comprising applying a first topical formulation as recited to the integumentary wound, required in instant claims 21 and 24; (c) applying a second topical formulation as recited onto a periwound area around the integumentary wound, required in instant claims 22 and 25; and (d) wherein the integumentary wound is caused by a skin disease or condition, wherein the skin disease or condition is ulcers and erosions related to diabetes, required in instant claim 27.
However, in the same field of endeavor of compositions comprising cannabinoids, with respect to limitations (a)-(d), Eyal teaches cannabinoid compositions comprising at least one cannabinoid in a specific amount in treating conditions and/or symptoms associated with at least one of and including ulcers, see abstract.
Eyal teaches the at least one cannabinoid is selected from the group consisting of and including THC (where Eyal defines THC to refer to THCa (tetrahydrocannabiniolic acid, e.g. required in instant claim 1 and instant claim 7) and/or to THC (tetrahydrocannabiniol), see paragraph [00149]) and combinations thereof; and the conditions and/or symptoms comprise ulcer, optionally pressure ulcer and/or diabetic ulcer (e.g. ulcers and erosions related to diabetes, required in instant claim 27), see paragraph [0036].
Eyal teaches the composition is administered topically (e.g. applying a first topical formulation, required in instant claim 21, instant claim 24 and instant claim 25), see paragraph [00241].
Eyal teaches administering a first composition (e.g. a first topical formulation, required in instant claim 21) comprising a cannabinoid and a first primary terpene followed by administering to a subject a second composition (e.g. a second topical formulation, required in instant claim 22) comprising the first cannabinoid and a secondary primary terpene, see paragraph [0086].
Eyal teaches the composition is for administration as a mouthwash (e.g. an oral formulation, required in instant claim 26), see paragraph [00207].
Eyal teaches the composition comprises tetrahydrocannabinol (THC) and/or tetrahydrocannabinolic acid (THCa), wherein THC and/or THCa is in a total concentration of at least 1% by weight, see paragraph [00187].
Based on the 1% by weight of THCa as taught by Eyal above, the Examiner respectfully notes that would result in 10 mg/mL of THCa in the liquid composition, would correspond to the range of the cannabinoids comprise at least 0.1 mg/ml tetrahydrocannabinolic acid, required in instant claim 1, instant claim 7, and instant claim 21.
With respect to the limitation “onto a periwound area around the integumentary wound”, required in instant claim 22; the Examiner reasonably interprets this limitation as a physical limitation that is met as ‘068 recites as discussed above and Eyal teaches topically administering a composition meeting the structural components of cannabinoids as required in instant claim 21, from which instant claim 22 depends; wherein the composition of Eyal is administered, particular as a mouthwash; in treating conditions and/or symptoms associated with at least one of and including an ulcer, particularly diabetic ulcers, as discussed above. In addition, ‘068 recites the topical instillate of reference claim 1 is in the form of an oral application to an integumentary wound or a mucous membrane wound. Thus, this limitation will be met.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included limitations (a)-(d) into the compositions as recited by ‘068 as discussed above, as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated to administer the topical instillate and/or the topical formulation taught by ‘068 onto the integumentary wound as recited by ‘068; for example the integumentary wound is the diabetic ulcer as taught by Eyal above. One of ordinary skill in the art would have had a reasonable expectation of success to have included limitations (a)-(d) into the compositions as recited by ‘068 above, as both ‘068 recites and Eyal teaches topical compositions for instillation onto integumentary wounds; wherein the composition comprises cannabinoids as required by instant claims 1, 7 and 21 as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined recitations of ‘068 and the teachings of the prior art.
This is a provisional nonstatutory double patenting rejection.
(II) Claims 1-13 and 21-27 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 23, 25 and 30 of copending Application No. 17/043,068 (Applicant: Vinsan Therapeutics Inc., claim set filed 04/23/2025) in view of Eyal et al. (Filed 13 May 2019, WO-2019220324-A2, PTO-892 mailed 02/24/2025) and Lazar (Filed 01 August 2019, WO-2020024056-A1, PTO-892 mailed 02/24/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to compositions comprising one or more cannabinoids, one or more terpenes, one or more flavonoids and a liquid carrier; and methods of their use.
‘068 recites and Eyal teaches as set forth above. Although ‘068 does not recite and Eyal does not teach a transdermal base comprising a liposomal component, required in instant claim 23.
However, in the same field of endeavor of compositions comprising cannabinoids, Lazar teaches a composition for topical administration or for oral administration, see abstract. Lazar teaches the composition is administered in a manner selected from the group consisting of and including transdermal (e.g. a transdermal base required in instant claim 23), see paragraph [0085]. Lazar teaches the compositions are formulated and/or prepared for topical administration or topical application; the compositions suitable for topical application may be in the form of a gel; they may also be prepared so as to comprise nanosized materials such as liposomes (e.g. the liposomal component, required in instant claim 23), see paragraph [0096]. Lazar teaches nanosized materials are often used as skin penetrating enhancers, as they are reported to enhance skin penetration compared to larger particles, and are more likely to penetrate the stratum corneum, see paragraph [0096]. Lazar teaches the compositions are used in a method for reducing pain, see paragraph [00112].
Lazar teaches a composition comprising at least one cannabinoid, wherein the at least one cannabinoid is isolated from Cannabis, see paragraph [0012].
Lazar teaches isolated compounds from the cannabis plant include cannabidiol (CBD), cannabidiolic acid (CBDA); delta-9-tetrahydrocannabinolic acid A (THCA-A), delta-9-tetrahydrocannabinolic acid B (THCA-B), and delta-9-tetrahydrocannabinolic acid-C4 (THCA-C4), see paragraph [0040].
With respect to the limitation of “the first topical formulation and second topical formulation”, required in instant claim 23; the Examiner reasonably interprets this limitation as a physical limitation that is met as ‘068 recites and Eyal and Lazar teach all structural components that are recited in the first and second topical formulations; ‘068 recites and Eyal and Lazar teach there compositions are formulated as topical compositions; and Eyal teaches administering multiple compositions as described above. Thus, based on the combined recitations of ‘068 and the teachings of Eyal and Lazar above, the Examiner reasonably interprets the physical limitations of the first and second topical formulations will be met.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have included the transdermal base comprising a liposomal component taught by Lazar into the compositions and methods as recited by ‘068 and taught by Eyal above as combining prior art elements according to known compositions and methods to yield predictable results. One of ordinary skill in the art would have been motivated used the nanosized materials, for example liposomes, as skin penetrating enhancers as taught by Lazar. One of ordinary skill in the art would have had a reasonable expectation of success to have included the transdermal base comprising a liposomal component taught by Lazar into the compositions and methods recited by ‘068 and taught by Eyal as discussed above, as ‘068, Eyal and Lazar are all directed to topical compositions comprising one or more cannabinoids as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined recitations of ‘068 and the teachings of the prior art.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed in this action.
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 JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a