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 .
Election/Restrictions
Newly submitted claim 15 directed to a species that is independent or distinct from the invention originally claimed and subject to restriction under 371 Unity of Invention standards for the following reasons:
Applicant has presented claims 14 and 15 which each claim a mutually exclusive species as claimed. The species of claim 14 was previously examined in claim 11. Claim 11 was rejected based upon one or more soluble components in the form of water soluble nicotine bitartrate particles sorbed with the first particles (microcrystalline cellulose). This rejection meets the limitation of newly presented claim 14, wherein the second type of particles are water soluble particles, and thus the species limitation does not comprise a special technical feature under unity of invention.
Since applicant has received an action on the merits for the originally presented species, the species of claim 14 has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 15 is withdrawn from consideration as being directed to a non-elected species. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Claims
Claims 1-17 are pending. Claims 13-17 are new. Claim 15 is withdrawn. Claims 1-12 are amended.
Response to Amendment
The Response of 1/26/2026 is entered. The amendment to claim 1 overcomes the objection to that claim. The amendments to claims 2-13 overcome the rejections made under 35 USC 112, and thus these rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 01/26/2026 have been fully considered but they are not persuasive. Applicant has not argued that any of the double patenting rejections of record are traversed, and thus these rejections are maintained.
Applicant to one degree or another has attacked the references used in the rejection. Applicant argues that Soundaranathan and Pharmatrans aren’t relevant, and Axelsson doesn’t provide a motivation to combine with Bragd. These positions seem likely to go to Appeal, and Applicant deserves a consistent explanation as to why these references are available as analogous prior art, the teachings they contain are appropriately used in the rejections below, and that these arguments are unpersuasive.
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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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.
Regarding the Pharmatrans disclosure, Applicant’s specifications across the four applications are not identical. Applying the test for field of endeavor, an examination of each specification is required to consider whether or not Pharmatrans, which teaches microcrystalline cellulose, highly optimized for drug release, is within the inventor’s field of endeavor.
The specification discloses the use of water insoluble particles that may be particles of microcrystalline cellulose, ([pg 4 lines 26-28]), having a particle size of between 0.3 mm to 3.0 mm, ([pg 5 lines 28-32]), and discloses the use of nicotine in the form of a nicotine compound, which can include various types including nicotine bitartrate, ([pg 7 lines 5-10]).
Additionally, the Examiner makes the following finding: Nicotine bitartrate is a highly soluble salt (a water soluble particle).
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, which 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, not 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, 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 also 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. It teaches the technique, and it teaches 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 that the technique of Axelsson would work to 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 evidence, Applicant may need to Appeal Examiner’s decision, where Examiner’s 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 one of ordinary skill in the art would have no motivation to combine the teachings of Bragd with Axelsson.
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 this is a use for the MCC. Axelsson teaches a technique for this, applicable to MCC particles.
Examiner freely acknowledges (this issue was raised by the Examiner and dealt with in the first rejection on the merits) that Axelsson’s pouch comprises smaller MCC particles. Yet, there is no evidence that the sorbtion technique would not work on Cellets 1000, a MCC designed for the controlled release of actives. Applicant suggests there is no motivation for combining the teaching of Axelsson with Bragd, but the rejection of claim 1 relies on the technique of Axelson regarding the sorbtion of nicotine onto MCC, applied to Cellets 1000. 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 I Examples of Rationales (D). It is asserted that Cellets 1000 is a known product made by Pharmatrans for the controlled release of actives. This is based on both Pharmatrans and Soundaranathan. 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.
Applicant arguments regarding the motivation for one of ordinary skill in the art to modify the Cellets 1000 according to the technique of Axelson is 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) 1-14 and 16-17 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 evidenced by Cellets 1000 cited on IDS of 9/24/2025, NPL cite 6 considered by Examiner on 03/02/2026 (evidencing bulk density of MCC having a range of particle sizes).
Regarding claims 1-3, and 5, Bragd discloses:
A pouched product for oral use, ([0032]), comprising
a liquid permeable cover material, ([0033] the pouch is a nonwoven saliva permeable pouch), and
a filling material comprising a particulate material consisting of water insoluble particles, ([0085] microcrystalline cellulose which is known to be hydrophilic), and
one or more water-soluble components in addition to the particulate material, ([0085] nicotine or a salt thereof, polysaccharides such as maltitol and mannitol, [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])),
the filling material being enclosed by the liquid permeable cover material, ([0033]),
the particles of the particulate material will inherently have a particle density and a bulk density.
Bragd further 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 alternatives where the filling material is free from tobacco material, ([0061], the filling material comprises microcrystalline cellulose and nicotine salt; [0085] disclosing an alternative 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. Bragd suggests a typical range of tobacco from 50-80% of tobacco material when it is present, ([0087]), 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 explicitly disclose the particles of the water insoluble particulate material (microcrystalline cellulose) has a particle density in the range of from 0.9 g/cm3 to 2.0 g/cm3, that the particle density being at least 1.4 times greater than the bulk density of the particulate material, or the filling material comprising tobacco material in an amount within the range of from 0.05 wt% to 10 wt% based on the total weight of the filling material, or particulars regarding the combination of microcrystalline cellulose and nicotine salt.
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, ([Homogenerous distribution and controlled release]).
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 is thus reasonably pertinent to the problems faced by the inventor. Soundaranathan 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 +/- 20 µm, with a particle density of 1.437 g/cm3, ([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)]).
Cellets 1000 evidences that MCC 1000 with a particle size of between 1000-1400µm will have a bulk density of 0.80 g/cm3.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention provide the oral pouched product of Bragd with a filling material free from tobacco material (because this alternative is suggested) or to modify the alternative with tobacco material to have an amount within the range from 00.05-10%, based on the disclosure of Bragd. 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. Thus, while Bragd anticipates the limitation of a filling material free from tobacco material, Bragd also meets the limitation of a filling material comprising tobacco material within a range of 0.05-10% wt.
It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to choose microcrystalline cellulose a filing material where the average particle size 1-2 mm or above, according to the disclosure of Bragd, as modified by Axelson, Pharmatrans, and Soundaranathan. 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]). Thus, one of ordinary skill in the art would reasonably expect that insoluble particulate filler (microcrystalline cellulose) would be held within the nonwoven, if the particle size were between 1-2 mm. Axelsson teaches using microcrystalline cellulose as a carrier for nicotine salts, but with a different nonwoven and a smaller particle size. Pharmatrans teaches that microcrystalline cellulose was available in the larger size ranges similar to the size of the tobacco particles held within the nonwoven of Bragd, and Soundranathan teaches that the particle sizes of MCC 1000 microcrystalline cellulose had a particle size of 1.215 mm +/- 20 µm.
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 to use MCC 1000 as the microcrystalline cellulose as the water insoluble particulate material, to be used as a carrier for nicotine salt as taught by Axelsson, based on the teachings of Pharmatrans and Soundaranathan. Bragd reasonably suggests that particles between 1-2mm will work in the nonwoven liquid permeable cover material, Pharmatrans suggests that MCC cellets are particularly advantageous for use in the controlled release active ingredient products. Soundaranathan reasonably suggests that MCC 1000 teaches is available product with a particle density that is 1.4 times the bulk density because Soundaranathan discloses the particle size is between 1-2mm and has a particle density of 1.437 g/cm3, ([3.2.1. Swelling data, Table 1]), Celletts 1000 evidences that the bulk density of the MCC 1000 will be 0.8 g/cm3, and the calculated ratio of particle density to bulk density for MCC 1000 is 1.796 g/cm3, which meets the claimed limitation.
Regarding claim 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 with an amount of MCC according to the teachings of Axelsson. Axelsson suggests compositions of an oral pouch filling material that are almost entirely all the nicotine-carrier complex, and one of ordinary skill in the art would have found it obvious to provide a filling material in an amount according to Axelsson, with a low nicotine percentage as 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%, which overlaps the claimed range of insoluble particle filling material.
Regarding claim 6, modified Bragd discloses the pouched product of claim 1.
The MCC 1000 used in modified Bragd will inherently meet the limitation of a water insoluble particulate material contains less than 0.5% of particles passing through a sieve having a mesh size of 250 µm, because the size distribution of all of the particles is greater than mesh size of 250 µm.
Regarding claim 7, modified Bragd discloses the pouched product of claim 1. Bragd discloses that the filling material may comprise nicotine, the nicotine added in the form of a nicotine compound, ([0061]).
Regarding claim 8-9, modified Bragd discloses the pouched product of claim 1. Bragd discloses that the filling material comprises one or more water soluble components, ([0085] polysaccharides such as maltitol and mannitol, [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]).
Regarding claim 10-11, modified Bragd discloses the pouched product of claim 1. Modified Bragd discloses the filling material may comprise nicotine salt and MCC, ([0061]). 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, as discussed in the rejections above. Such a composition will have portions where the nicotine salt is present in the interstices of the MCC particles of the filler material.
Regarding claim 12, modified Bragd discloses the pouched product of claim 1. Bragd discloses that the liquid permeable cover material is nonwoven, ([0033]).
Regarding claims 13, modified Bragd discloses the ouched product of claim 1. Bragd discloses that the water insoluble particulate material constitutes a first type of particles, MCC particles and where the filling material comprises a second type of particles nicotine salt, ([0061] the filling material comprises microcrystalline cellulose and nicotine bitartrate).
Regarding claim 14 and 16, modified Bragd discloses the pouched product of claim 13. Modified Bragd discloses the filling material may comprise nicotine salt and MCC, ([0061] the filling material comprises microcrystalline cellulose and nicotine bitartrate). Nicotine bitartrate is known to be highly soluble in water and MCC is known to have (at least) a different composition than nicotine bitartrate.
Regarding claim 17, modified Bragd discloses the pouched product of claim 13. Bragd discloses alternatives where the filling material is free from tobacco material, ([0061], the filling material comprises microcrystalline cellulose and nicotine salt; [0085] disclosing an alternative where the oral pouch is a non-tobacco snuff product – the filling material has no tobacco).
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 9, and 12-16 of copending Application No. 18/255876. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1-2, 18/255876 discloses:
A pouched product for oral use comprising, (claim 1),
a liquid permeable cover material, (claim 1), and
a filling material comprising a particulate material consisting of water insoluble particles, (claim 1), and
one or more water-soluble components in addition to the particulate material, (claim 15),
the filling material being enclosed by the liquid permeable cover material, (claim 1),
the particles of the particulate material having a particle density and a bulk density, (inherent), characterized in that the particles of the particulate material have a particle density in the range of from 0.9 g/cm3 to 2.0 g/cm3, (claim 1, overlapping range),
the particle density being at least 1.4 times greater than the bulk density of the particulate material, (although not claimed, substantially disclosed in the Reference Specification 0013),
the filling material having a pre-use moisture content of from 1% by weight of the filling material to 35% by weight of the filling material, (claim 1), and
the filling material being free from tobacco material or the filling material comprises tobacco material in an amount within the range of from 0.05 wt% to 10 wt% based on the total weight of the filling material, (claim 1).
Regarding claim 3, 18/255876 discloses the pouched product of claim 1, but and claims wherein the particles of the particulate material comprises water insoluble particles. It would be obvious to modify the reference application according to the 18255873 which claims the water insoluble particles in a similar pouch may be microcrystalline cellulose (claim 2 of 18255873), (microcrystalline cellulose is a known water insoluble hydrophilic particle).
Regarding claim 4, 18/255876 discloses the pouched product of claim 3, wherein the water insoluble particles constitute 75% by dry weight to 99% by dry weight of the filling material, (claim 6).
Regarding claim 5, 18/255876 discloses the pouched product of claim 1, wherein the particles of the water insoluble particulate material have an average particle size within the range of from 0.3 mm to 3.0 mm, (claim 1), overlapping the claimed range.
Regarding claim 6, 18/255876 discloses the pouched product of claim 1, wherein the particulate material contains less than 0.5% of particles which are small enough to pass through a sieve having a mesh size of 250 µm, (claim 2).
Regarding claim 7, 18/255876 discloses the pouched product of claim 1, wherein the filling material comprises nicotine, the nicotine being added in the filling material in the form of a nicotine compound, (claim 12).
Regarding claim 8, 18/255876 discloses the pouched product of claim 1, wherein the filling material comprises an additive selected from the group consisting of a flavouring agent, a sweetener, a humectant, and any mixture thereof, (claim 13).
Regarding claim 9, 18/255876 discloses the pouched product of claim 1, wherein the additive comprises a flavouring agent, (claim 14).
Regarding claim 10, 18/255876 discloses the pouched product of claim 1, wherein at least one of the one or more water soluble components is present on an outer surface of at least some of the particles of the water insoluble particulate material, (claim 15).
Regarding claim 11, 18/255876 discloses the pouched product of claim 1, wherein at least one of the one or more water soluble components is present in interstices between the particles of the water insoluble particulate material, (claim 16).
Regarding claim 12, 18/255876 discloses the pouched product of claim 1, wherein the liquid permeable cover material is a nonwoven material, (claim 9).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 DANIEL E VAKILI whose telephone number is (571)272-5171. The examiner can normally be reached Monday - Friday 7:30 am - 4:30 pm.
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/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747