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 Claims
Claims 1-19 are pending. Claims 1-16 are amended. Claims 17-19 are new.
Response to Amendment
Claim 1 was object to because a portion of the claim was bolded. The bolding has been removed, and thus this objection has been overcome.
Claim 1 contained a typographical error with regard to the ratio, which created confusion regarding the scope of the claim, and has been corrected to refer consistently to the pouched product, and thus the 112(b) rejections of claim 1 have been overcome.
Claims 2-16 have been amended to refer to “pouched product” instead of “a pouched product”, and thus these rejections under 112(b) have been overcome and are withdrawn.
Claim 6 had been amended to refer to the pouched product instead of the product, and thus this rejection under 112(b) has been overcome and is withdrawn.
Claims 2-16 no longer depend on any claim that is considered indefinite, and thus these further rejections under 112(b) are also withdrawn
Claims 6 and 10 were rejected under 112(d) as failing to further limit a claim upon which they depend. The limitations of claim 6 were amended to further narrow the scope of claim 1 and claim 10’s dependency was changed to be on claim 1. These amendments overcome the 112(d) rejection in each of these claims, and thus the rejections under 112(d) are withdrawn.
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive. The rejections below have been edited for clarity, but the grounds of rejection remain the same.
Applicant has four Applications with similar subject matter docketed to the Examiner.
Applicant to one degree or another has attacked the references used in the rejection of the Applications. Applicant argues that Soundaranathan and Pharmatrans aren’t relevant, and Axelsson doesn’t provide a motivation to combine with Bragd. These arguments seem likely to go to Appeal as the arguments were raised in the interview of 12/29/2025,.
Under US practice, for an Examiner to rely on a reference under 35 USC 103, it must be analogous art to the claimed invention, MPEP 2141.01(a) I. “A reference is analogous to the claimed invention if: (1) the reference is in the same field of endeavor as the claimed invention( even if it addresses a different problem), or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that “same field of endeavor” and “reasonably pertinent” are two separate tests for establishing analogous art; it is not necessary for a reference to fulfil both tests in order to qualify as analogous art.” Id. “When more than one prior art reference is used as the basis for an obviousness rejection, it is not required that the references be analogous to each other.” Id.
Field of Endeavor
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Id.
Reviewing Axelsson against the field of endeavor test, there is no doubt that the reference is within the Applicant’s field of endeavor. The “reality of the circumstances” is that Axelsson teaches the use of a nicotine-cellulose combination for the preparation of a snuff composition for the controlled release of nicotine over 30 minutes, (Field of Invention [pg 1 lines 3-9], Detailed description of the invention [pg 2 lines 24-28]). Axelsson teaches “the term "nicotine-cellulose combination" is intended to denote a solid material composed of a cellulose which has sorbed (adsorbed and/or absorbed) a well-defined amount of nicotine (either as free base or as a pharmaceutically acceptable salt, complex or solvate) e.g. in voids or pores within the cellulose. The terms "nicotine-cellulose adduct" and "nicotine-cellulose carrier complex" as used herein are intended to have the same meaning as the term "nicotine-cellulose combination". As used herein cellulose is an example of a carrier.” Axelsson teaches putting the nicotine cellulose composition in a pouch or membrane, such as a nonwoven fabric, ([pg 3 lines 15-19]).
To the extent Applicant is arguing that Axelsson is not in the inventor’s field of endeavor, these arguments are entirely without merit, because regardless of how narrowly Applicant may wish to construe the inventor’s field of endeavor, Axelsson is squarely within it.
Pharmatrans teaches microcrystalline cellulose, highly optimized for drug release, is within the inventor’s field of endeavor.
The specifications disclose the use of a filling material within the pouch, and in all cases the filling material may comprise water insoluble particles and water soluble particles, where the water insoluble particles may be microcrystalline cellulose having a particle size of 0.5 mm to 3.0 mm, ([pg 4-5 lines 34-10]), and discloses the use of nicotine in the form of a nicotine compound, which can include various types including nicotine bitartrate, ([pg 6 lines 4-9]).
Pharmatrans is a company that makes microcrystalline cellulose for the controlled release of pharmaceutical actives, sold under the brand name Cellets, which are available in almost any particle size, with a specific range disclosed from 0.1mm to 1.0 mm. Applicant appears to be arguing that because Cellets, a microcrystalline cellulose product designed for the controlled release of actives (which one of ordinary skill in the art would understand includes nicotine), is not specifically disclosed as designed for oral pouch use, thus it must not be within the field of endeavor. This argument is unpersuasive.
A reference does not need to be anticipatory to be within the field of endeavor, nor is it the narrowest possible conception of the field, or even the particular focus within a given field. MPEP 2141.01(a). See reproduced portion of the MPEP above.
Pharmatrans is within the field of endeavor, because the inventor’s field of endeavor broadly includes the controlled delivery of active ingredients with microcrystalline cellulose. It is also relevant to the particular problem faced by the inventor, the problem of where MCC may be acquired that is suitable for inclusion in the pouch products under development. Pharmatrans is analogous art.
Soundaranathan is equally within this field of endeavor. Soundaranathan teaches the swelling characteristics of pharmaceutical particles, (Title), where the particles studied include a variety of Cellet sizes including Cellets 1000, ([pg 2-3 section 2.1 Materials]) and teaches other properties including the size, shape, density, and maximum absorption ratio of the particles, where the particles are MCC, ([pg 4 table 1]). The field of endeavor embarked upon by the inventor includes references that teach about the characteristics of the materials the inventor contemplates as suitable within that endeavor. This is the “reality of the circumstances” as understood by the Examiner.
Soundaranathan is also analogous as pertinent to the problem faced by the inventor, the properties of the MCC which may be available commercially, such that one of ordinary skill would consider the reference in determining whether Cellets are suitable for use in the oral pouched products under development. The swelling characteristics of MCC go directly to whether the MCC would be suitable for use in the product, and the reference depicts the swelling characteristics of MCC for several sizes and at several time points, see reproduction below:
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Examiner finds that Soundaranathan is analogous art as it is within the inventor’s field of endeavor, and also that the reference analogous art because it is reasonably pertinent to the problems faced by the inventor; either finding is sufficient to consider the reference as analogous. Applicant arguments that Soundranathan is not relevant argues the wrong standard (relevancy) and is not persuasive, because under the correct standard evaluated above, the reference is analogous art.
Axelsson has been established above as within the inventor’s field of endeavor and is available for all that it teaches. Applicant argues that one of ordinary skill in the art would not be motivated to combine the teachings of Axelsson with Bragd. Applicant representative is skilled and deliberate with this phrasing, but this argument is unpersuasive because it mischaracterizes the obviousness rejection and fails to consider the teaching of all the references together.
In response to Applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Axelsson teaches a method of sorbing nicotine onto MCC. The MCC presented in the rejection is Cellets 1000, a highly optimized MCC designed for the controlled release of active ingredients, see above. Bragd, Pharmatrans, and Soundaranathan do not inform one of ordinary skill in the art of how to apply nicotine to the MCC so that it can be controllably released, despite Pharmatrans disclosing that controlled release of actives is a use for the MCC they sell.
Axelsson teaches a technique for sorbing nicotine onto MCC particles.
This is nothing more than the application of a known technique (nicotine sorbtion onto MCC) to a known product (Cellets 1000) ready for improvement (the improvement being the addition of nicotine) to yield predictable results (controllably releasable nicotine). MPEP 2143 Examples of Basic Requirements of a Prima Facie Case of Obviousness, I. Examples of Rationales (D). It is asserted that Cellets 1000 is a known product made by Pharmatrans for the controlled release of actives.
Soundaranathan teaches that Cellets 1000 were available as prior art, and Pharmatrans teaches the commercial availability of Cellets, as well as broad functional uses for products sold under the trade name Cellets. Axelsson teaches a known technique of sorbing nicotine onto MCC, which would be applicable to Cellets 1000 an MCC product designed and optimized for the controlled release of active ingredients. One of ordinary skill in the art would have recognized applying the known technique of Axelsson would have yielded predictable results (nicotine would be expected to sorb onto and/or into the Cellets 1000 MCC particles), and this would have resulted in an improved system where the Cellets 1000 MCC would have comprised a nicotine source and been suitable for inclusion in the pouch according to Bragd, as MCC with soluble nicotine where the MCC particles would be large enough to be contained by the nonwoven material that forms the pouch, and result in a nicotine bitartrate – microcrystalline cellulose complex that would deliver nicotine to a user over time from a pouch.
Axelsson teaches that MCC is a particularly suitable carrier, ([pg 6 lines 9-10]), and teaches that nicotine interacts with the carrier by absorbing into and/or adsorbing onto the carrier, where the interaction is completely or nearly completely reversible, ([pg 6 lines 19-23]). Axelsson teaches that in a specific embodiment, nicotine is sorbed onto microcrystalline cellulose, ([pg 7 line 15]). Axelsson then teaches, in general, the mean particle size of the carrier such as microcrystalline cellulose is one that is not too low and neither too high, ([pg 7 17-18]). The reference does provide some exemplary ranges, and states “[i]n the examples herein a quality of microcrystalline cellulose having a mean particle size of 0.180 has proved well-suited for the present purpose.” Axelsson does not suggest that the technique of sorbing nicotine onto the surfaces of MCC particles would not work on larger MCC particles. Instead it teaches both the technique and preferred sizes for the embodiments disclosed by Axelsson. Applicants argue that because it teaches the preference, the broader teaching of the technique is unavailable to one of ordinary skill in the art. There is no basis for this speculation on the record, and the idea that the technique would not work on the larger particles appears to be objectively false.
Bragd has a more open and porous nonwoven web. The function of that web is to contain the filling material within the pouch. Bragd discloses that tobacco particles, ground and sieved to have a uniform size distribution, will be suitable in a size range of 1-2mm, suggesting that the MCC used with the nonwoven of Bragd should be similarly sized to ensure it is retained in the pouch. Pharmatrans and Soundaranathan teach properties and availability of Cellets 1000, such that it has characteristics that make it suitable for the inclusion of the pouch of Bragd. Axellson teaches a technique for combining the nicotine bitartrate with the MCC, which is expected to work on the Cellet 1000 particles. This combination is considered obvious as explained above. Applicant arguments regarding the teachings of Axelsson being inapplicable to larger MCC particles such as Cellets 1000 is not persuasive. There is no evidence to contradict the technique of Axelsson would create a nicotine bitartrate and MCC complex suitable for inclusion in the pouch of Bragd, as modified by the teachings of the references.
This appears to be a situation where Applicant is arguing at the Examiner, rather than providing reasoned statements backed by evidence in support of their arguments. MPEP 2145 requires consideration of applicant’s rebuttal arguments and Evidence. Examiner pointed out the disparity between the particle sizes taught by Axelsson and the particle sizes reasonably required by Bragd, and given the teachings of all the references found that the combination of Axelsson’s technique to the larger particles would be obvious.
Examiner has carefully considered all of Applicant arguments regarding the application of Axelsson to modify Bragd in view of all of the references. Applicant arguments are not persuasive, despite such consideration. There is no evidence that one of ordinary skill in the art would have believed the sorbtion technique would not be workable across a larger range of particles than the particle sizes preferred by Axelsson for their embodiments. MPEP 2145 I. Argument Does Not Replace Evidence Where Evidence is Necessary. Applicant is invited to submit evidence upon which Examiner can rely, which demonstrates or clearly represents the technique of sorbing nicotine bitartrate onto Cellets 1000 would not work. An affidavit will be considered, an affidavit supported by results would be better. If Applicant is able to support the combination doesn’t work, Examiner will have a strong basis for withdrawing the rejection of record. Merely arguing that one of ordinary skill in the art wouldn’t apply the technique of Axelsson is not persuasive.
Examiner carefully considered whether this technique would work across the range of particle sizes used in the rejection before making the Non-Final rejection, Examiner considered Applicant arguments regarding the application of the technique across the range of particle sizes used in the rejection during the interview of 12/22/2025 in Application 18255873, and Examiner has carefully considered the arguments presented by Applicant in response to each of the Non-Final rejections. These arguments are not persuasive, and Examiner is unable to support a Notice of Allowance based on them. In the absence of providing evidence, Applicant may need to Appeal Examiner’s decision, where this decision can be reversed, and the Application can proceed to allowance. Currently, Examiner believes it would be error to allow the claims in these applications based on Applicant argument.
Applicant argues that the rejections of record are traversed, Response pg 8 line 1. Applicant argues in the Response that none of the references inherently teach a ratio of t2/t1 of between 1.0 and 1.5, Response pg 8 heading through the top of pg 10. This argument is unpersuasive because it misunderstands the rejection of record, which is based on the combination of the references.
Applicant noticed that inherency was used in the analysis of Bragd and concludes that the rejection of record asserted that the claimed property thickness was inherent; this is not persuasive because the argument relies on a Applicant’s misstatement of the rejection. The rejection did not conclude the property as claimed was inherent, merely that all pouches must inherently have a t2/t1 ratio. The rejection of record then found that the claimed configuration is reasonably suggested by Bragd to one of ordinary skill in the art – stated another way, configuring the pouched product to have the swelling property as claimed during use is considered obvious based on the disclosure of Bragd as modified by Axelsson and in light of the teachings of the other references that disclose the properties of Cellets 1000, including that it swells.
Applicant acknowledges that the swelling property of microcrystalline cellulose (MCC) was known in the prior art. Bragd discloses sizing and configuring the oral pouch to fit comfortably and discreetly in a user’s mouth. This is understood to mean that, one of ordinary skill in the art would find it obvious to selecting the composition in a way reasonably designed to ensure that the size remains the same or swells within a reasonable range. Configuring a pouch, such that its thickness decreased overtime would allow the pouch to dislodge from the preferred location of use, and potentially present a swallowing or even a choking hazard. Such an outcome would be inconsistent with the disclosure of Bragd, which discloses configuring the pouch to remain in place during use. Likewise, configuring the pouch to swell excessively would result in an uncomfortable fit, and potentially result in the pouch also dislodging and becoming a swallowing/choking hazard as well. The t2/t1 limitation in a range of 1-1.5 is an obvious design choice based on a pouch composition reasonably suggested by Bragd, and nothing in the modifications of Bragd suggested by the teachings of Axelsson and the other references alter that finding. Examiner has provided a solid basis for rejecting this limitation soundly supported by references cited to the Applicant; the required burden has been more than met. All of Applicant arguments have been fully considered but are not persuasive.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bragd et al. (EP 3192380 A1) in view of Axelsson et al. (WO 2007/104573 A2), Soundaranathan et al. “Quantification of swelling characteristics of pharmaceutical particles”, International Journal of Pharmaceutics, published online 09/25/2020 and Pharmatrans, “Pharmatrans Cellets – Microcrystalline Cellulose Pellets, Corporate Release 08/06/2020.
Regarding claim 1, Bragd discloses:
a pouched product for oral use, ([0033]), comprising:
a liquid permeable cover material, ([0033] saliva permeable), and a filling material, ([0033]),
the filling material comprising a first type of particles, ([0061] the filling material may comprise microcrystalline cellulose, a first type of particles).
the first type of particles being water insoluble particles, (microcrystalline cellulose is insoluble),
the filling material being enclosed by the liquid permeable cover material, ([0054] explicitly indicating the saliva permeable pouch encloses the filling material),
characterized in that the filling material is free from tobacco material, ([0061], [0085] disclosing an alternatives where the oral pouch is a non-tobacco snuff product – the filling material has no tobacco), or the filling material comprises tobacco material, ([0056], [0080] disclosing that when the oral pouch product is an oral pouched smokeless tobacco product, the filling material may comprise tobacco), Bragd further discloses compositions where the filling material is free of nicotine, ([0083]), and
the filling material comprises one or more water soluble components, ([0061] the filling material may comprise nicotine salt – which is water soluble), or ([0095] salt, such as sodium chloride is added mainly for its effect on taste, which is also water soluble), as well as other additives that may be water soluble, ([0104]-[0105]).
Bragd suggests a typical range of tobacco from 50-80% of tobacco material when it is present, ([0087]). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify this range to an amount from 0-10%, based on the disclosure. By suggesting that the oral pouch may have no tobacco, and suggesting that the oral pouch may have tobacco, ranges of tobacco that overlap a range of from 0-10 wt% based on the total weight of the filling material, are reasonably suggested to one of ordinary skill in the art, for the obvious reason of providing nicotine pouch where the primary source of nicotine is from the microcrystalline cellulose and nicotine salt formulation, and the tobacco is meant for flavoring to oral pouch product, which would provide the obvious benefits of designing and controlling the nicotine release rates of the pouch product while still providing some tobacco flavoring.
Bragd discloses that the prior art oral use snuff included dry snuff having a water content of less than 10%, moist snuff with a water content of above 40%, and semi-dry products with between 10-40% water content, (0002]). Bragd discloses that non-post-moisturized products are referred to as “white snus: and by some users are considered to have a more appealing appearance, ([0023]). Bragd discloses that ([0101] the moisture content may be within the range from 10-60%, with the alternatives of a post moisturized or a non-post-moisturized oral product recited). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have provided the oral pouched product as a non-post-moisturized product, which is reasonably suggested to have a moisture content in the lower portion of the range, such as 10%, for the disclosed reason of providing a more visually appealing product.
Bragd discloses that the non-woven holding the filling material may have an open area of at least 12%, such as at least 15%, ([0055]), and that filling material held within the pouch may include tobacco material (see above) and that the tobacco material may be finely divided, and ground, ([0066]). Finely divided is disclosed as meaning an average particle size of less than 2mm, ([0075]). Bragd further discloses that the finely divided tobacco material may be in granulated form or powder form, with an average particle size of between 1-2mm, ([0088]). Bragd does not disclose what size particles the microcrystalline cellulose should have, which are combined with the nicotine salt to provide the nicotine source in the oral nicotine, ([0061]). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected a commercially available a microcrystalline cellulose product having an average diameter of between 1-2 mm, known to be suitable for controlled release of active ingredients, for the particle to be mixed with the nicotine salt because microcrystalline cellulose was identified as a suitable material for the mixture and this size of particle was known to be held within the non-woven material used to contain the filling material, because the tobacco particles were disclosed as having this size. One of ordinary skill in the art would have had a reasonable expectation of success in using microcrystalline cellulose in this size range because this size particle was known to be suitable for the tobacco powder used in the pouch.
Bragd discloses that the pouched product is intended for the oral cavity, such as buccal placement – placed between the upper or lower gum, and the lip or cheek – and sized and configured to fit comfortably and discreetly in a user’s mouth, ([0100]), similarly to the way prior art pouches are disclosed as being used, ([0005]). Bragd discloses that the prior art pouches may be rectangular and pillow shaped, ([0019]-[0021]). Bragd does not disclose the particular shape the oral pouch must have. It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have configured the shape of the oral pouch to be having a first main surface and a second main surface and a thickness between the first main surface and the second main surface, in a rectangular pillow shape, because that shape is disclosed as a shape that is configurable to fit comfortably in a user’s mouth.
the pouched product having:
a pre-use thickness (t1) determined as the maximum distance between the two main surfaces of the oral pouched product at an applied pressure force of 0.5 N, the pouch must have a pre-use thickness under this pressure, which though undisclosed is inherent, and
a post-use thickness (t2) determined as the maximum distance between the two main surfaces of the oral pouched product at an applied pressure force of 0.5 N after a use period of 10 minutes according to the test procedure disclosed herein, the pouch must have a post-use thickness after a user period of 10 minutes under this pressure, which although undisclosed is inherent, and
the pouch post-use thickness divided by the pre-use thickness inherently forms a ratio, which may be expressed in a numerical value.
The ratio is an inherent property of the oral pouch product, but the ratio for the pouch of Bragd is not disclosed, nor does Bragd disclose the amount of microcrystalline cellulose to use in the filling material.
Axelsson teaches a nicotine-cellulose combination for an oral release of nicotine into the oral cavity of a user, ([pg 1 lines 2-7]), and thus is within the inventor’s field of endeavor. Axelsson teaches the use of cellulose which has sorbed (adsorbed and/or absorbed) nicotine (either as a free base or as a pharmaceutically acceptable salt), using the cellulose as a carrier, ([pg 2-3 lines 34-4]). Axelsson teaches that the nicotine cellulose, which may include other excipients or additives, is enclosed in a membrane material, ([pg 4 lines 4-6]). Axelsson teaches that the composition may include tobacco, ([pg 4 line 24-26]). Axelsson teaches that a particularly suitable cellulose is microcrystalline cellulose, ([pg 6 lines 9-10]), and that nicotine may be sorbed on microcrystalline cellulose, ([pg 7 line 15]). While Axelsson teaches a general mean particle size of the microcrystalline cellulose for their compositions that is one that is not too low and neither too high, and suggests a possible range from about 0.5 mm to 0.005 mm, ([pg 7 lines 17-25]), this is not considered limiting with regard to the disclosure of Bragd, which has a specific nonwoven membrane that may not hold the insoluble particles of this smaller size range. Axelsson does teach an amount of the nicotine carrier, (microcrystalline cellulose) may be present in a range from 2-98% by weight, ([pg 8 lines 12-18]). Axelsson teaches that the amount of nicotine sorbed onto the carrier (microcrystalline cellulose) can range to between 1% and more than 50%, ([pg 8 lines 20-24]).
Pharmatrans teaches that Cellets are a highly optimized microcrystalline cellulose product for controlled release and drug delivery, ([Homogeneous distribution and controlled release]), and thus is reasonably pertinent to the problem of what microcrystalline cellulose may work in the pouch. The product brochure indicates that Cellets are made under good manufacturing practices (GMP), that the particles can be made in almost any particle size range, broadly described from 0.1-1mm, that the particles can be made in a uniform spherical shape and structure, and that the particles are the perfect tool for combinatory and controlled release products, ([Homogeneous distribution and controlled release]).
Soundaranathan is reasonably pertinent to problem of what public availability of MCC was available prior to the effective filing date of the claimed invention and the properties of that MCC, and thus is considered analogous prior art as reasonably pertinent to the problem faced by the inventor, even if it is considered to be outside the inventor’s field of endeavor, MPEP 2141.01 (a) I. To Rely On A Reference Under 35 U.S.C. 103, It Must be Analogous Art To The Claimed Invention. Soundaranathan informs one of ordinary skill in the art of the properties of MCC sourced by Pharmatrans under the Cellets trade name, including the swelling property, but also other properties which are claimed across Applicant applications. Soundaranathan teaches particle swelling of several commercially available grades of microcrystalline cellulose, which is relevant to configuring the pouch product to fit comfortably in the user’s mouth between the lip/cheek and gums and provides information for several types including Cellets500 (MCC 500), Cellets700 (MCC700), and Cellets1000 (MCC 1000), ([2.1 Materials, 1st paragraph]). Soundaranathan teaches that the size of MCC 1000 is 1.215 mm, with a particle density of 1.437, ([3.2.1. Swelling data, Table 1]), depicting the size change of the particles as increased when exposed to water after 10 minutes, ([3.2.1. Swelling data, Fig. 5.]), and graphically showing an increase in the radius of the MCC1000 particle of between 0.030-0.035mm, ([3.2.1. Swelling data, Fig. 6 (b)]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Bragd according to the teachings of Axelsson, Pharmatrans and Soundaranathan. As above, Bragd reasonably suggests the use of MCC with a diameter of between 1-2mm. Pharmatrans teaches that Cellets are a commercially available MCC particle, which can be made in a particle that meets the size requirements of Bragd and teaches that Cellets would be workable in a controlled release formulation. Soundaranathan teaches the swelling of Cellets 1000 after 10 minutes, as well as the specific size of the particle and the density of Cellets 1000. Axelsson teaches the technique of sorbing nicotine onto a carrier of MCC, the amount of nicotine carrier complex may be varied from 2-98% in the composition, and the percentage of nicotine sorbed onto the carrier may be from 1-50% of the nicotine carrier composition. Because Bragd teaches that the filling material may have no nicotine, it is reasonably suggested that a pouch composition with a low percentage of nicotine salt is compatible with the disclosure of Bragd, and such a composition is reasonably suggested to one of ordinary skill in the art, especially as a composition meant to taper off a user’s dependence on nicotine.
One of ordinary skill in the art would have found it obvious to configure the inherent property of the pouched product t2/t1 ratio to be between 1 and 1.5, such that the pouch remains in place between the lip and gum even during use, while soluble components may be dissolving, by configuring the pouch to expand during use by virtue of the swelling of the Cellets 1000 MCC.
Regarding claim 2, modified Bragd discloses the pouched product of claim 1. Bragd further discloses that the first type of particles may be microcrystalline cellulose, ([0061] the filling material may comprise microcrystalline cellulose, a first type of particles).
Regarding claim 3-4, modified Bragd discloses the pouched product of claim 1. Bragd further discloses the first type of particles may be MCC, ([0061]), and that the oral pouch product may contain no nicotine, ([0083]). Bragd does not teach the composition amount of MCC in the filling material.
Axelsson teaches an amount of the nicotine carrier, (microcrystalline cellulose) may be present in a range from 2-98% by weight, ([pg 8 lines 12-18]).
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have further modified Bragd according to the teachings of Axelsson. Because Bragd reasonably suggests a low nicotine pouch composition, by suggesting versions of the pouch that contain nicotine and do not contain nicotine. Axelsson suggests compositions of an oral pouch filling material that are almost entirely all the nicotine-carrier complex. One of ordinary skill in the art would have found it obvious to provide a filling material according to Bragd, with a low nicotine percentage as taught by Axelsson, and in an amount taught by Axelsson, to provide a low dose nicotine product for user’s attempting to reduce their nicotine consumption, while still providing a pouch composition configured to remain in place while in use. Such a composition is expected to have the material property where the MCC particle defines the volume of the filling material, since it is insoluble and present in an amount suggested by Axelsson that may be as high as 98%.
Regarding claim 5, modified Bragd discloses the pouched product of claim 1. As above Bragd further discloses pouch compositions where the filling material contains tobacco, ([0056]), and where the filling material does not, ([0061]). Although Bragd suggests a typical range of tobacco from 50-80% of tobacco material when it is present, ([0087]). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to modify this range to a much lower amount such as from 0.05-1%, based on the disclosure which suggests no tobacco is required, for the obvious reason of providing nicotine pouch where the primary source of nicotine is from the microcrystalline cellulose and nicotine salt formulation, and yet including a small amount of tobacco is meant for subtle flavoring to oral pouch product, which would provide the obvious benefits of designing and controlling the nicotine release rates of the pouch product while still providing some tobacco flavoring.
Regarding claim 6, modified Bragd discloses the pouched product of claim 1. Modified Bragd discloses that the pouched product may be configured to fit comfortably between the lip and gum of the user during use, ([0100]). As in the rejection of claim 1 above, the swelling property of MCC was known.
One of ordinary skill in the art, before the effective filing date of the claimed invention, would have found it obvious to configure the modified pouched product of Bragd to swell such that the t2/t1 ratio was between 1.1 and 1.5, to ensure the pouched product remained in place during use, even while soluble components dissolved. One of ordinary skill in the art would have recognized that the swelling property of MCC could be used as part of the compositional design of the product, to account for the losses of pouch material to dissolution, and appreciated that configuring the product to swell in this range would account for sensory fatigue and dissolution losses, ensuring that the user would continue to feel the product in their mouth as well as retain it in place, to reduce the risk of choking and inadvertent swallowing.
Regarding claim 7, modified Bragd discloses the pouched product of claim 1.
Soundaranathan teaches that the Cellets 1000 MCC particles have a bulk density of 1.437 g/cm3.
Regarding claim 8, modified Bragd discloses the pouched product of claim 1. Bragd discloses the filling material comprises nicotine which is added in the filling material in the form of a nicotine compound, ([0061]).
Regarding claim 9-10, modified Bragd discloses the pouched product of claim 1. Bragd discloses that the filling material may comprise a number of additives, ([0086]), ([0095]-[0098]).
Regarding claim 11-14, modified Bragd discloses the pouched product of claim 1. Modified Bragd discloses the second type of particles may be nicotine salt, as described in the rejection of claim 1 above. Axelsson describes the mixture of nicotine salt and MCC, where the MCC acts a carrier for the water-soluble nicotine salt, sorbing it onto the surfaces of the MCC. Such a composition will have portions where the nicotine salt is present in the interstices of the MCC particles.
Regarding claim 15-16, modified Bragd discloses the pouched product of claim 1. Bragd discloses that the liquid permeable cover material is a nonwoven material having a basis weight of 20 g/m2 to 25 g/m2, ([0033]).
Regarding claim 19, modified Bragd discloses the pouched product of claim 1. Bragd further discloses that the filing material further comprises a second type of particles, in the form of an additional ingredient, such as salt in the form of sodium chloride, ([0073]), which may be added for its effect on taste ([0095]), and is known to be water soluble.
Claim(s) 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bragd et al. (EP 3192380 A1) in view of Axelsson et al. (WO 2007/104573 A2), Soundaranathan et al. “Quantification of swelling characteristics of pharmaceutical particles”, International Journal of Pharmaceutics, published online 09/25/2020 and Pharmatrans, “Pharmatrans Cellets – Microcrystalline Cellulose Pellets, Corporate Release 08/06/2020, as applied to claim 1, and in further view of Rodrigues, “Microparticulated salts mix: An alternative to reducing sodium in shoestring potatoes”, LWT - Food Science and Technology, 01/26/2016, cited as relevant prior art in the Office Action of 08/27/2025.
Regarding claim 17-18, modified Bragd discloses: The pouched product according to claim 1.
Modified Bragd discloses that Cellets 1000 may be used as a carrier for nicotine, and has an average particle size of 1.215 mm.
Bragd further discloses that the filing material further comprises a second type of particles, in the form of an additional ingredient, salt, ([0073]), which may be added for its effect on taste ([0095]).
Bragd does not disclose the relative size of the MCC particles to the salt particles.
Rodrigues teaches a technique of milling salt to increase its effect on taste, ({Abstract]), and is thus reasonably pertinent to the problem faced by the inventor of providing a palatable pouched product for oral use. Rodrigues teaches that reducing the size of sodium chloride particles promotes a greater perception of saltiness, ([pg 391 paragraph 1]). Rodrigues tested the saltiness of salt with an unreduced particle size against salt samples of was increasingly small size, see pg 392 table 2:
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The clear result was that salting potency is greater in salt mixtures with reduced particles sizes, pg 392:
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have applied the technique of Rodrigues to the salt added to the pouch of modified Bragd, resulting in a salt particle size that is smaller than the MCC particle size. This is considered no more than the obvious applying of a known technique to a known product ready for improvement to yield predictable results, MPEP 2143 I. Examples of Rationales (D). Modified Bragd discloses the base device upon which the additional limitation can be seen as an improvement. The prior art also contained a known technique of milling sodium chloride to reduce its particle size, increasing its saltiness effect, which would allow less salt to be used while still achieving a palatable product. One of ordinary skill in the art would have recognized that applying the technique of milling the salt would result in a more uniform distribution of salt particle sizes, resulting in a more consistent salty taste provided, and that the decrease in salt particle size would allow for users to perceive the same level of saltiness, while using less salt in the product, resulting in an improved system where taste is maintained but users are exposed to less salt. One of ordinary skill in the art would have reasonably chosen to use the sieve size 0.150 mm, because the sample produced from this technique had the most consistent particle size distribution. The Cellets 1000 MCC is the first particle type having an average particle size of 1.215mm. the sodium chloride of sample 3 has a D90 average particle size of 0.193 mm, which is smaller than the first particle size, and the ratio of the first particle size to the second particle size is 6.295, within the claimed range of 2 to 10.
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.
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/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747