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 .
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.
Claim(s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of Applicant provided Document Titled CBD Medic...(herein after D1), Document Titled !:! Dragon (herein after D2), Document Titled “Ultra Strength Bengay” (herein after D3), Stinchcomb WO 2010126501 (herein after D5), and Pagliaro US 20140018750 (herein after D5). All these references are in the file-wrapper and therefore not provided.
Document DI discloses a cream for relieving muscle and joint pain associated with backache, arthritis, strains, bruises and sprains. Said cream comprises I 0% camphor and I 0% menthol, as well as hemp extract and magnesium oxide. The cream also comprises other ingredients such as purified water, natural oils etc. Said cream should be applied on the skin up to 3 or 4 times a day (whole document). Although the hemp extract and the magnesium oxide are categorized as "inactive ingredients",
they are present in the formulation and, hence, their therapeutic effect is an integral part of their overall effect and is therefore inherent. Document DI discloses all the components and at the same amounts as claimed in claim I and some of the dependent claims, for the same intended therapeutic purpose and some of the dependent claims of the present application.
Document D2 discloses a cannabinoid-based ointment (balm) comprising THC (175 mg), CBD (175 mg), menthol, camphor and mint oil. Said ointment provides a cooling and numbing effect and prevents pain signals coming from deep tissue (whole document).
Document D3 discloses Bengay® cream for the treatment of muscle and joint pain associated with backache, arthritis, strains, bruises and sprains. Said cream comprises 4% camphor, 10% menthol and 30% methyl salicylate, acting as topical analgesics, and additional excipients (whole document).
Document D4 discloses topical compositions of cannabinoids for treating sprains and strains associated with traumatic injury and for conditions such as arthritis (abstract,
paragraph [0023]). The cannabinoid can be selected from the group consisting of different cannabinoids, including THC, cannabinol etc., wherein the preferable cannabinoid is cannabidiol (CBD). The total amount of CBD in the composition is 0.1 %-95% (paragraphs [0009], [0017]). Although the preferred dosage form is gel, the topical
compositions may as well be in the form of ointments, creams, lotions, sprays, etc. (paragraph [0066]). Document D4 further mentions that the compositions can be prepared at a pH suitable for administration to a mammal (3-10), a viscosity of 1,000-100,000 cps, and may contain alcohols, such as ethyl alcohol, in various concentrations (paragraphs [0049], [0061 ]-[0062]).
Document D5 discloses pharmaceutical compositions for applying magnesium to relieve muscle cramping and muscle injuries (paragraphs [0002], [0005]). The exemplified pharmaceutical compositions are transdermal patches containing 8% magnesium sulfate, however it is also mentioned that the same compositions may be applied directly on the skin of the patient over the affected muscle, via a gel, ointment, lotion, cream or spray (paragraph [0028]). In addition, document D5 teaches that concentrations of less than 8% magnesium, such as 4%-8% magnesium, can be suitable as well (paragraph [0030]).
Pain relief products for topical application (in the form of ointments, creams, sprays, lotions etc.) comprising different combinations of cannabinoids, menthol, camphor and methyl salicylate are known from documents Dl-D5, some of them being available on the market. Since most lotions are emulsions, it would be obvious for a skilled person to include emulsions in the scope of dosage forms suitable for the compositions.
The addition of magnesium salts to said products, as well as using magnesium salts in topical compositions for the treatment of muscle pain relief, are learned from documents D 1 and D5.
Although D 1 and D5 do not disclose the use of magnesium chloride salt or a hydrate thereof as the magnesium ion in the compositions, other magnesium salts are known for the same therapeutic purpose, and magnesium chloride being one of the most common magnesium salts.
Therefore, the use thereof would be obvious for a skilled person. In addition, no advantage of magnesium chloride over other magnesium salts has been demonstrated in the present application. Topical cannabinoid or hemp compositions, especially CBD-containing compositions, for the treatment of muscle pain and arthritis are also learned from document Dl-D2 and D4.
In addition, selection of an optimal concentration of an active ingredient is a routine task for a skilled person in the art of pharmaceutical preparations and is evaluated by trial and error experiments. These claims relate to different physicochemical characteristics of the compositions. As mentioned above, topical compositions for pain relief in the form of creams or sprays are known from documents Dl-D5. In addition, topical compositions having a viscosity of 1,000-100,000 cps are learned from document D4. Although none of the cited documents mentions the specific viscosity of the preparations or the use of roll-ons, the use of said standard features would be obvious for a skilled person in the art of topical preparations, especially since said application also uses such standard features that are not uniquely adapted for the claimed compositions. The viscosity values claimed in claims 29-30 are typical of the dosage forms they correspond to.
The deliberate added emphasis seen above is to correspond the limitations of the individual dependent claims (more on this later). In addition , Applicant is encouraged to use well-known technique word-search to locate specific clam limitations in this action (and in the cited references): Ctrl+F is a keyboard shortcut that opens the "find" function, allowing you to search for text within a document, web page, or application. On a Mac, the equivalent shortcut is Command+F. Pressing it brings up a search bar where you can type in keywords, and the program will highlight all instances of that text, with arrows to navigate between them.
The ingredients (active and inactive), % amounts etc. are already known in the prior art. The rejection is under 35 USC § 103, not under 35 USC § 102.
Consider the limitations of dependent claims 8-13: These relate to % amounts of Mg2+. That this action does not ignore this is easily ascertained by using the above noted elementary word technique!.
The critical limitations of the claims as to the ingredients and excipients are found throughout the cited references as well known in the art used for the intended purpose. Routine optimization of these with respect to amount and ratios are within the purview of one of skill in the art. If the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. The differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such specific concentration 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).
The global cannabidiol market size was estimated at USD 9.14 billion in 2024 and is projected to reach USD 22.05 billion by 2030, growing at a CAGR of 15.8% from 2025 to 2030. The CBD market size is expected to grow with the increasing legalization of hemp-based products. Obviousness can 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.
“Go Together Like Oil, Water….. and Cannabis?”
file:///C:/Users/nchandrakumar/Downloads/blog.modernistpantry.com-Go%20Together%20Like%20Oil%20Water%20and%20Cannabis.pdf
https://en.wikipedia.org/wiki/Magnesium_oil
Therefore there is nothing unobvious in the claims.
Suggestion:
See prosecution history of US 11696909.
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.
Claim(s) 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11696909 further in view of Applicant provided Document Titled CBD Medic...(herein after D1), Document Titled !:! Dragon (herein after D2), Document Titled “Ultra Strength Bengay” (herein after D3), Stinchcomb WO 2010126501 (herein after D5), and Pagliaro US 20140018750 (herein after D5). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims contain overlapping subject matter as explained below.
Base claim 1 of 11696909:
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The difference is
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in 11696909
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The conflicting claims include limitations corresponding to the limitations in the instant dependent claims. For example, the critical Mg2+ amount in instant dependent claim 11 is within the range in the instant dependent claim 10. Additional claim limitations in both cases are also found in the teachings in D1-D5:
Document DI discloses a cream for relieving muscle and joint pain associated with backache, arthritis, strains, bruises and sprains. Said cream comprises I 0% camphor and I 0% menthol, as well as hemp extract and magnesium oxide. The cream also comprises other ingredients such as purified water, natural oils etc. Said cream should be applied on the skin up to 3 or 4 times a day (whole document). Although the hemp extract and the magnesium oxide are categorized as "inactive ingredients", they are present in the formulation and, hence, their therapeutic effect is an integral part of their overall effect and is therefore inherent. Document DI discloses all the components and at the same amounts as claimed in claim I and some of the dependent claims, for the same intended therapeutic purpose and some of the dependent claims of the present application.
Document D2 discloses a cannabinoid-based ointment (balm) comprising THC (175 mg), CBD (175 mg), menthol, camphor and mint oil. Said ointment provides a cooling and numbing effect and prevents pain signals coming from deep tissue (whole document).
Document D3 discloses Bengay® cream for the treatment of muscle and joint pain associated with backache, arthritis, strains, bruises and sprains. Said cream comprises 4% camphor, 10% menthol and 30% methyl salicylate, acting as topical analgesics, and additional excipients (whole document).
Document D4 discloses topical compositions of cannabinoids for treating sprains and strains associated with traumatic injury and for conditions such as arthritis (abstract, paragraph [0023]). The cannabinoid can be selected from the group consisting of different cannabinoids, including THC, cannabinol etc., wherein the preferable cannabinoid is cannabidiol (CBD). The total amount of CBD in the composition is 0.1 %-95% (paragraphs [0009], [0017]). Although the preferred dosage form is gel, the topical compositions may as well be in the form of ointments, creams, lotions, sprays, etc. (paragraph [0066]). Document D4 further mentions that the compositions can be prepared at a pH suitable for administration to a mammal (3-10), a viscosity of 1,000-100,000 cps, and may contain alcohols, such as ethyl alcohol, in various concentrations (paragraphs [0049], [0061 ]-[0062]).
Document D5 discloses pharmaceutical compositions for applying magnesium to relieve muscle cramping and muscle injuries (paragraphs [0002], [0005]). The exemplified pharmaceutical compositions are transdermal patches containing 8% magnesium sulfate, however it is also mentioned that the same compositions may be applied directly on the skin of the patient over the affected muscle, via a gel, ointment, lotion, cream or spray (paragraph [0028]). In addition, document D5 teaches that concentrations of less than 8% magnesium, such as 4%-8% magnesium, can be suitable as well (paragraph [0030]).
Pain relief products for topical application (in the form of ointments, creams, sprays, lotions etc.) comprising different combinations of cannabinoids, menthol, camphor and methyl salicylate are known from documents Dl-D5, some of them being available on the market. Since most lotions are emulsions, it would be obvious for a skilled person to include emulsions in the scope of dosage forms suitable for the compositions.
The addition of magnesium salts to said products, as well as using magnesium salts in topical compositions for the treatment of muscle pain relief, are learned from documents D 1 and D5.
Although D 1 and D5 do not disclose the use of magnesium chloride salt or a hydrate thereof as the magnesium ion in the compositions, other magnesium salts are known for the same therapeutic purpose, and magnesium chloride being one of the most common magnesium salts.
With combined teachings of in the claims of 11696909, D1-D5 one of skill in the art would arrive at the instant limitations.
The prior art made of record and not relied upon is considered pertinent here:
Feldman, Understanding ‘Evergreening’ : Making Minor Modifications Of Existing Medications To Extend Protections, Health Affairs June 2022 41:6, 801-804
Dwivedi, Evergreening: A deceptive device in patent rights, Technology in Society 32 (2010) 324–330.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIZAL S CHANDRAKUMAR whose telephone number is (571)272-6202. The examiner can normally be reached M-F 8-5 EST.
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/NIZAL S CHANDRAKUMAR/Primary Examiner, Art Unit 1625