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
Acknowledgement is made of the response filed on September 19, 2025. In that response claim 11 was cancelled. Claims 1-10 and 12 are treated on the merits in this action. 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 Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Gow (US 2005/0069596) in view of Cinosi (Cinosi, E., et al., Following (the Roots) of Kratom (Mitragyna speciosa): The Evolution of an Enhancer from a Traditional Use to Increase Work and Productivity in Southeast Asia to a Recreational Psychoactive Drug in Western Countries, BioMed Research International, Vol. 2015, Article ID 968786) AS EVIDENCED BY FormerlyNormally (Far Exceeded my Expectations Kava & Kratom, Erowid Experience Vaults, Mar, 10, 2012, available at https://www.erowid.org/experiences/exp.php?ID=94846, accessed on November 28, 2023) AND Utomo (Utomo, R.S., et al., Local culture of kratom (Mitragyna speciosa) consumption in Kapuas Hulu district, AIP Conf. Proc. 2563, 050026 (2022)).
Gow teaches compositions comprising combinations of kava extract and one or more anxiolytics for “enhancing the therapeutic activity of an anxiolytic” (abstract; see title; paras. 0011-16, 0018-26; claims 1-20). Preferably kava extract is obtained using supercritical CO2 extraction (paras.0023, 0029, 0030). It comprises kavain and the other compounds in claims 1 and 5 (paras.0025, 0034). Suitable formats include oral dosage forms including liquids, emulsion, and others in claims 9 and 10 ( paras.0022, 0027, 0069).
The total kavalactone concentration is 0.1 mg to 400 mg, e.g., 300 mg (para.0031). The ratio of kavain to dihydrokavain is most preferably 1:1 and comprise greater than 50% of the total kavalactones (para.0033), the ratio of methysticin and dihydromethysticin is preferably 1:2 to 2:1 and they comprise less than 30% of the total kavalactones (para.0032), and the ratio of yangonin and desmethoxyyangonin is preferably 1:2 to 2:1 and comprise less than 20% of the total kavalactones (para.0034). These ratios and concentrations are within the range in claim 7. For result-effective variables such as the concentration of active compounds in a composition, in the case where claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP § 2144.05 (citations omitted). Furthermore, optimization within prior art conditions or through routine experimentation does not support patentability absent comparative evidence of criticality of the claimed range. See MPEP § 2144.05 (II) (citations omitted).
Combined weight percentage of flavokavains A and B is between about 0.3% to about 3%, e.g., 0.3% which is well below the maximum of “substantially free” according to the Specification (see Specification as filed, para.[0012]).
Gow does not specifically teach combining its composition with a ground kratom leaf solid phase as recited in the present claims.
Cinosi teaches that mitragynine is kratom’s main active constituent in producing psychoactive effects (title; abstract; p.3 Results, Fig.1 and accompanying text). Cinosi notes “kratom is commonly taken in combination with a variety of other recreational “classic drugs” (e.g., alcohol, …) and NPS (e.g., kava,…)” (p.7 left col. Last para.). Cinosi teaches how kratom has been commonly used. “Traditionally, in certain regions of Southeast Asia, the chopped fresh or dried leaves of the tree are chewed or made into tea…” (p.1 left-rt. col. (emphasis added)). “The onset of liver injury is described to occur within 2 to 8 weeks of starting regular use of kratom powder…” (p.4 left col. second para.),; see p.6 left col. first para.).
FormerlyNormally chronicles a user experience in mixing a tea of kava root powder with a tea of kratom leaf powder. The combination produced “a perfect feeling of contentment” and “[o]ne of the most pleasant drug experiences of [his/her] life…[with] effective herbal relaxation”. In other words the combination of kava root powder with a tea of kratom leaf powder worked as an anxiolytic. Furthermore Utomo discusses local cultural use of kratom leaves by people in West Kalimantan (Indonesia) (title; abstract). Utomo states that the “form of kratom leaves consumed is generally dry leaf powder”, and “[u]sually the size of this powder is filtered with a cloth so that the dried leaves into grains smaller and equal to 0.3 mm pass through a stainless steel filter” (p. 050026-4 Fig. 4 and accompanying text). In other words Utomo evidences traditional cultural use of kratom leaves as powder having a grain size of 300 µm or less, by people in regions wherein kratom is a native plant.
It would have been prima facie obvious for one having ordinary skill in the art before the effective filing date to combine the teachings of Gow and Cinosi and combine Gow’s composition with kratom leaf powder as recited in the instant claims. The skilled person would have been motivated to do so because Gow teaches combinations of kava extract and one or more anxiolytics for “enhancing the therapeutic activity of an anxiolytic” (abstract), Cinosi teaches that kratom in dried leaf tea form or powder is commonly taken in combination with kava, and FormerlyNormally evidences that such combination results in “a perfect feeling of contentment” and “[o]ne of the most pleasant drug experiences of [his/her] life…[with] effective herbal relaxation”.
Response to Arguments
Applicant's arguments filed September 19, 2025 have been fully considered but they are not persuasive. Applicant states, “Utomo is not eligible as prior art” because it published on October 31, 2022, after the effective filing of this application. Moreover, “should the Examiner seek to enter a new ground[sic] of rejection”, the next action “should be a second non-final”. (Remarks, 1-2, September 19, 2025.)
“In certain circumstances, references cited to show a universal fact need not be available as prior art before the effective filing date of applicant’s claimed invention.” MPEP §2124 (citations omitted). “Some specific examples in which later publications showing factual evidence can be cited include situations where the facts shown in the reference are evidence ‘that, as of an application’s filing date,… or that characteristics of prior art products were known, In re Wilson, 311 F.2d 266, 135 USPQ 442 (CCPA 1962).’” MPEP §2124 (citing In re Koller). As stated in the bold-texted sentence above, which sentence was provided in the previous rejection, Utomo is an evidentiary reference. Utomo evidences traditional cultural use of kratom leaves as powder having a grain size of 300 µm or less, by people in regions wherein kratom is a native plant. Figure 3 for example shows consumption for “more than 10 years”. Also, “consumption of kratom leaves has become the local wisdom of the people of Kapuas Hulu Regency for generations” (p. 050026-3 (emphasis added)). Cinosi teaches the use of powdered kratom; Utomo is merely evidences that characteristics of prior art products, i.e., the particle size of the powder Cinosi teaches, were known.
The above rejection was modified solely with bold-texting the sentence about Utomo’s evidentiary value, for Applicant’s notice. Therefore Applicant’s note about the next action being made non-final is premature.
Applicant next contends that the Gow’s composition is for treating anxiety disorders which requires prolonged, regular administration (Remarks, 3), and somehow “[w]hen Cinosi is considered in its entirety, it is clear that one of ordinary skill…would not only lack motivation to modify Gow’s composition to include ground kratom leaf, but would also be discouraged from doing so”. (Remarks, 4 first para.) Applicant then refers to “Cinosi’s belief at the time that administering kratom with other compounds presents safety concerns and from prolonged use. (Remarks, 4 second para.)
In response it is noted that Applicant’s reading of Gow is overly narrow. The quotes from Gow in the Remarks (p.3) plainly state, “may be administered daily, for one or more times”, “may be administered as a combined composition,…”, “administration may occur at specific times to treat or prevent specific conditions”. Also, “at least once” does include once, not just multiple times that Applicant emphasizes in the quotes. Gow nowhere requires multiple dosing of its invention over weeks, months, and years, as Applicant attempts to persuade. Furthermore Cinosi discusses common, i.e., casual consumption of kratom. “It must also be noted that kratom is commonly taken in combination with a variety of other recreational “classic drugs” … and NPS (e.g., kava, mephedrone,…)” (p.7 left col. (emphases added)). “Consumers can be classified into two main groups: the first includes those who solely use ketum to improve physical tolerance to laborious work and the second polydrug users who attempt to manage drug withdrawal symptoms or reduce the intake of other opiates like heroin” (p.4 rt.col.). Both types of consumers would use kratom on a regular basis for the duration of their need which would be over days or weeks. Therefore the skilled person would have been motivated to combine the teachings of Gow and Cinosi because Gow teaches combinations of kava extract and one or more anxiolytics for “enhancing the therapeutic activity of an anxiolytic” (abstract), Cinosi teaches that kratom in dried leaf tea form or powder is commonly taken in combination with kava, and FormerlyNormally evidences that such combination results in “a perfect feeling of contentment” and “[o]ne of the most pleasant drug experiences of [his/her] life…[with] effective herbal relaxation”.
Applicant next argues “Gow does not disclose kratom at all”, and the anxiolytics Gow discloses are pharmaceuticals such as benzodiazepine. (Remarks, 4 last para. (emphasis in original).)
“A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments”, and “[d]isclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments”. MPEP §2123 (citations omitted). Here Gow teaches co-administering kava extracts with anxiolytics. “Anxiolytics as used herein include pharmaceutical agents used to treat anxiety-related conditions, and include, but are not limited to, benzodiazepine…” (Gow para.0018). As Gow plainly states here, anxiolytics include, i.e., is not limited to, pharmaceutical agents such as benzodiazepine.
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.
Claims 1-10 and 12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 37-47 of U.S. Patent No. 18/213022.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets are drawn to compositions comprising: a liquid phase comprising an aqueous liquid and a CO2 extract of kava, wherein the CO2 extract of kava comprises kavain, dihydrokavain, methysticin, dihydromethysticin, yangonin, and desmethoxyyangonin; and a solid phase dispersed in the liquid phase, wherein the solid phase consists of ground kratom leaf.
Response to Arguments
Applicant's arguments filed September 19, 2025 have been fully considered but they are not persuasive. Applicant requests the rejection for the claims 1-10 and 12 be held in abeyance. (Remarks, 6.)
The provisional double patenting rejection(s) is/are maintained for the reasons discussed herein. They will be maintained until Applicant submits properly executed terminal disclaimer or arguments that effectively overcome the rejection(s).
CONCLUSION
THIS ACTION IS MADE FINAL. 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 H. S. PARK whose telephone number is (571)270-5258. The examiner can normally be reached on weekdays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H. SARAH PARK/Primary Examiner, Art Unit 1614