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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/08/2025 has been entered.
Priority
This application is a CON of 17183580 filed 02/24/2021 (PAT 11969502), which is a CON of PCT/IB2020/061476 filed 12/04/2020. PCT/IB2020/061476 has PRO of 63036248 filed 06/08/2020. PCT/IB2020/061476 is also a CIP of 16707117 filed 12/09/2019.
However, the subject matter of: one or more organic acids of instant claims 13-18; lemon balm extract of instant claim 22; and melatonin and lemon balm extract of instant claim 23, are not present in the disclosure or original claims of U.S. Application No. 16707117.
Thus, instant claims 13-18, 22 and 23 will not receive priority filing benefit of 16707117 filed 12/09/2019.
Accordingly, claims 1-12, 19-21 and 24-27 are afforded the effective filing date of 12/09/2019. Claims 13-18, 22 and 23 are afforded the effective filing date of 06/08/2020.
Status of the Claims
This action is in response to papers filed 12/08/2025 in which claims 2-3, 8, and 11 were canceled; and claim 1 was amended. All the amendments have been thoroughly reviewed and entered.
Claims 1, 4-7, 9-10 and 12-27 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejections and/or objections not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Interpretation
The term “optionally” in claim 23, 25 and 27 are interpreted as not required in the composition. For this office action and art rejection purposes, the components/elements following the term “optionally” in claims 23, 25 and 27 will be interpreted as components/elements that are made optional or not required, and thereby not part of the claimed composition.
As such, “vitamin B1 vitamin B7, tryptophan, lemon balm, chamomile, or a combination thereof” as recited in claim 23; “vitamins B1, B2, B6, B7, or a combination thereof” as recited in claim 25; and “vitamin B1, vitamin B7, or a combination thereof” as recited in claim 27, are made optional and interpreted as not part of the claimed composition.
New Rejections
Necessitated by Applicant’s Claim Amendments
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.
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.
Claim(s) 1, 4-7, 9, 13-20 and 22-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee et al (US 2010/0300464 A1) in view of Sakuma et al (US 2013/0203723 A1) and Victor et al (Us 2016/0324777 A1).
Regarding claims 1 and 20, Gee teaches an oral pouched product comprising a pouch containing moist botanical beads (particulates), said beads comprising moist botanical material, wherein the botanical material is a non-tobacco botanical material (Abstract; [0002], [0013]-[0015], [0026], [0030]-[0040], [0045], and [0070]-[0082]; claims 1, 4 and 6-9), thereby meeting the claimed “substantially free of tobacco.” In addition, nowhere in Gee does not teach the pouch contains nicotine, thereby meeting the claimed “substantially free of nicotine.” Gee further teaches the beads further contains microcrystalline cellulose, hydroxypropyl cellulose, and sweeteners ([0032]-[0035] and [0070]-[0071]; claims 6-9).
However, Gee does not teach the amounts of microcrystalline cellulose and hydroxypropyl cellulose, as well as, the salt of claim 1.
Regarding the amounts of microcrystalline cellulose and hydroxypropyl cellulose of claim 1, Sakuma teaches an oral composition comprising granulated substance (a particulate) containing a drug, hydroxypropyl cellulose in an amount of 0.1 to 20 weight%, particularly between about 1-3 weight% and microcrystalline cellulose in an amount of 25 weight% (Abstract; [0017]-[0045], [00122]-[00127], [00138]; Tables 3, 5, 8, 10, and 12).
It would have been obvious to one for ordinary skill in the art to optimize the amounts of microcrystalline cellulose and hydroxypropyl cellulose to amounts as claimed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Gee and Sakuma are drawn to oral composition containing particulates in which the particulates contains hydroxypropyl cellulose as a binder and microcrystalline cellulose as an excipient, and Sakuma provided the guidance for optimizing said hydroxypropyl cellulose to an amount of 0.1 to 20 weight%, particularly between about 1-3 weight% and microcrystalline cellulose to an amount of 25 weight%, which are amounts that reads on the claimed amount of “about 1% to about 5% by weight” for hydroxypropyl cellulose and “at least 20% by weight” for microcrystalline cellulose. Thus, an ordinary artisan provided the guidance from Sakuma would have routinely optimize the amounts of microcrystalline cellulose and hydroxypropyl cellulose in the composition to an amount between about 1-3 weight% for hydroxypropyl cellulose and 25% by weight for microcrystalline cellulose so as to achieve a desired beads/granules (particulates), and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding the salt of claim 1, Victor teaches an oral pouch containing a composition comprising cannabinoids, theanine, maca, ginseng, lemon balm, chamomile, and melatonin, wherein the composition is useful in assisting the user with mental focus, calming, vitality, relaxation, sleep, and immune support (Abstract; [0008]-[0086], [0102]-[0186]; claims 1-72). Victor teaches the composition further contains a salt such as sodium chloride (NaCl) to provide both flavor and a preservative action ([0169]).
It would have been obvious to one of ordinary skill in the art to include a salt such as sodium chloride in the beads that is filled in the pouch of Gee, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do because Victor provided the guidance to do so by teaching that a salt such as sodium chloride is added to a composition that is filled in a pouch so as to provide the oral pouch containing the composition with both flavor and preservative action. Thus, an ordinary artisan seeking to provide oral composition with a desired flavor and preservative action would have looked to including a salt such as sodium chloride in the beads that is filled in the pouch of Gee, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claim 4, as discussed above, Victor provided the teaching and guidance for including a salt such as sodium chloride in the beads that is filled in the pouch of Gee.
Regarding claims 5-7, Gee teaches the beads further contain flavors such as mint and cinnamon ([0038]-[0039]).
Regarding claim 9, as discussed above, Gee teaches the beads contain a botanical material.
Regarding claims 13-18, Sakuma teaches and provide guidance including citric acid in an amount less than 5 weight% so as to adjust the pH of the granulate ([0116]). It is noted that the amounts as taught in Sakuma overlaps the claimed range as recited in claims 14 and 15. Thus, the Courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of organic acid in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim 19, Victor teaches that the moisture content of the pouch can be optimized based on the amount of water that is used to moistened the composition that is filled in the pouch in which the internal water content is in a range from 1 wt% to 75 wt% prior to placement into the mouth ([0103]). It is noted that the range of 1 wt% to 75 wt% overlaps the claimed moisture content of “from about 20% to about 45% by weight.” Thus, the Courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of moisture content in the composition to achieve a desired moist pouch would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Regarding claim s 22-25, as discussed above, Victor teaches an oral composition comprising cannabinoids, theanine, maca, ginseng, lemon balm, chamomile, and melatonin, wherein the composition is useful in assisting the user with mental focus, calming, vitality, relaxation, sleep, and immune support (Abstract; [0008]-[0086], [0102]-[0186]; claims 1-72). It would have been obvious to one of ordinary skill in the art to include theanine, maca, ginseng, lemon balm, chamomile, and melatonin in the oral composition of Gee, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Victor teaches the use of theanine, maca, ginseng, lemon balm, chamomile, and melatonin provides a resultant oral product is useful in assisting the user with mental focus, calming, vitality, relaxation, sleep, and immune support. Thus, an ordinary artisan seeking to design an oral product which additionally provide assistance in mental focus, calming, vitality, relaxation, sleep, and immune support, would have looked to including include theanine, maca, ginseng, lemon balm, chamomile, and melatonin in the oral composition of Gee, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee et al (US 2010/0300464 A1) in view of Sakuma et al (US 2013/0203723 A1) and Victor et al (Us 2016/0324777 A1), as applied to claims 1 and 9 above, and further in view of Rabovsky et al (US 2016/0193306 A1).
The compositions of claims 1 and 9 are discussed above, said discussion being incorporated herein in its entirety. Regarding claim 10, Rabovsky teaches an oral composition containing botanical materials that used in purified form (bleached) so as to prevent unwanted or contaminating components in the resultant oral composition ([0006]-[0057] and [0230]).
It would have been obvious to one of ordinary skill in the art to use a purified (bleached) form of the botanical material of Gee, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Rabovsky indicated that it is advantageous to use a purified botanical material so as to prevent unwanted or contaminating components in an oral composition. Thus, an ordinary artisan seeking to avoid impurities in the beads of Gee would have looked to using purified (bleached) botanical material, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee et al (US 2010/0300464 A1) in view of Sakuma et al (US 2013/0203723 A1) and Victor et al (Us 2016/0324777 A1), as applied to claim 1 above, and further in view of Borschke et al (US 2013/0098377 A1).
The composition of claim 1 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 12, Borschke teaches an oral composition containing an active ingredient that is filled in a pouch, wherein the composition further contains known excipients including alginate, which functions as binder in the composition (Abstract; [0011] and [0030]).
It would have been obvious one of ordinary skill in the art to include alginate in the bead composition of Gee, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Borschke teaches that alginate can be added to bead composition that is filled in a pouch, as alginate is known binder typically added as one of the excipients in the manufacturing of oral pouches containing beads (Borschke: [0030]). One of ordinary skill in the art would have reasonable expectation of success of including alginate in the bead composition of Gee because Gee indicated that binders can be added to the beads so as to form a desired wet mass (Gee: [0032]-[0033]). Thus, an ordinary artisan seeking to produce an oral composition with a desired moisture content would have looked to including binders such as alginate in the beads of Gee, and produce Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 21 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gee et al (US 2010/0300464 A1) in view of Sakuma et al (US 2013/0203723 A1) and Victor et al (Us 2016/0324777 A1), as applied to claim 1 above, and further in view of Schirripa (US 2012/0107300 A1).
The composition of claim 1 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claims 21 and 23-27, Schirripa teaches an oral composition containing cannabinoid, caffeine, taurine, maca, Vitamin C, ginseng, vitamin B complex, guarana, and melatonin, wherein the oral composition is useful for increasing a patient’s energy, concentration and motivation, while enhancing the patient’s memory and mood (Abstract; [0008]-[0013] and [0027]-[0072]; claims 1-19).
It would have been obvious to one of ordinary skill in the art to include caffeine, taurine, maca, Vitamin C, ginseng, and vitamin B complex in the oral beads of Gee, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Schirripa teaches the use of caffeine, taurine, maca, Vitamin C, ginseng, guarana, and vitamin B complex provides a resultant oral product is useful for increasing a patient’s energy, concentration and motivation, while enhancing the patient’s memory and mood. Thus, an ordinary artisan seeking to design an oral product which additionally provide increase energy boost, would have looked to including caffeine, taurine, maca, Vitamin C, ginseng, guarana, and vitamin B complex in the oral beads of Gee, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant’s arguments in the Remarks filed on 12/08/2025 (on pages 6-9) with respect to claim(s) 1, 4-7, 9-10 and 12-27 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Maintained Rejections
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, 4-7, 9-10 and 12-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 11872231.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘231 significantly overlap with the subject matter of instant claims, i.e., compositions comprising microcrystalline cellulose as a filler in an amount of at least 20% by weight; hydroxypropyl cellulose in an amount by weight from about 1% to about 5%; at least one active ingredient including theanine, caffeine, taurine, vitamin B6 and vitamin B12; a salt; and at least one sweetener; and wherein the compositions have a moisture content of from about 20% to about 45% by weight, and wherein the compositions are substantially free of nicotine or free of tobacco, and wherein the compositions is filled a pouch to form a pouched product, and thereby the compositions are in particulate form .
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11872231.
Claims 1, 4-7, 9-10 and 12-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11969502 in view of Carroll et al (US 2014/0261472 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the Patent ‘502 significantly overlap with the subject matter of instant claims, i.e., compositions comprising microcrystalline cellulose as a filler in an amount of at least 20% by weight; at least one active ingredient including caffeine, taurine, theanine, vitamin B6 and magnesium; a salt; and at least one sweetener; and wherein the compositions have a moisture content of at least 30% by weight, and wherein the compositions are substantially free of nicotine or free of tobacco, and wherein the compositions are filled a pouch to form a pouched product, thereby the compositions are in particulate form.
Carroll teaches and provide guidance for including hydroxypropyl cellulose as a binder in an amount of less than 5% by weight in the composition of the Patent ‘502 (Carroll: [0004]-[0006], [0019], [0025]-[0027], [0063]-[0073]). It is noted that the range of less than 5% by weight of hydroxypropyl cellulose as taught by Carroll overlaps the claimed range of “about 1% to about 5%, based on the total weight of the composition. Thus, the Courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results showing criticality from the claimed parameters, the optimization of the amount of hydroxypropyl cellulose in the composition would have been obvious before the effective filing date of Applicant’s invention. See MPEP §2144.05 (I)-(II).
Consequently, the ordinary artisan would have recognized the obvious variation of the instant claimed subject matter over U.S. Patent No. 11969502 in view of Carroll.
Response to Arguments
Applicant's arguments filed 12/08/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims as amended are patentably distinguishable over the cited patents. Applicant further request the double patent rejections be held in abeyance. (Remarks, page 9).
In response, the Examiner. The instant claims as amended are not patentably distinguishable over Patents ‘231 and ‘502 for the reason(s) discussed above in the pending double patenting rejections, said reason(s) being incorporated herein in its entirety. With respect to Applicant’s request to hold the double patenting rejections in abeyance, it is noted that Applicant's request to hold the double patenting rejections in abeyance is not a proper response because a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02).
Accordingly, the double patenting rejections are maintained for the reason discussed above and pending the filing of a terminal disclaimer.
Conclusion
No claim is allowed.
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/DOAN T PHAN/Primary Examiner, Art Unit 1613