edDETAILED 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 1-18 are pending. Claims 1-15 are amended. Claims 16-18 are new.
Response to Amendments
The Response of 01/14/2026 is entered. The amendments to claims 1-15 overcome all of the objections to the claims, and thus the objections are withdrawn. The amendments to claims 1-15 overcome the rejections to these claims under 35 USC 112, and thus these rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 01/14/2026 have been fully considered but they are not persuasive.
Any changes to the grounds of rejection below were necessitated by Applicant’s Amendments.
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 of the Applications. Applicant argues that Soundaranathan and Pharmatrans aren’t relevant, and Axelsson doesn’t provide a motivation to combine with Bragd.
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
PNG
media_image1.png
203
705
media_image1.png
Greyscale
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 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. Specification 18255874, discloses the use of water insoluble particles that may be particles of microcrystalline cellulose, ([pg 4 lines 9-11]), having a particle size of between 0.3 mm to 3.0 mm, ([pg 4 lines 22-26]), and discloses the use of nicotine in the form of a nicotine compound, which can include various types including nicotine bitartrate, ([pg 6 lines 20-25]).
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.
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, 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:
PNG
media_image2.png
520
697
media_image2.png
Greyscale
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 to 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 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. 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 rejections, 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 has amended claim 1 to require that the filling material, comprising one or more water soluble components and one or more water insoluble particulate material, the water insoluble particulate material comprising water insoluble particles, contains less than 0.5% of particles passing through a sieve having a mesh size of 0.25 mm. Applicants allege that the rejection of record does not adequately address this new limitation. The Cellots 1000 technical specifications that provides evidence that the distribution of the Cellots 1000 is 85%+ within 1.0-1.4 mm. Applicant’s argue that more than 0.5% of the particles will pass through a screen of 0.25mm. Applicant argument is entirely speculative and unsupported by the available evidence.
Pharmatrans teaches that the Cellets brand has a narrow particle size distribution. The average size of Cellets 1000 is taught by Soundaranathan to be 1.215 mm. There is no evidence that a carrier designed to have a narrow particle size would have a size distribution that would be allow any of the material to pass through a 0.250 mm sieve. An extensive search turned up an evidentiary reference in response to Applicant’s assertions proves this is true. An evidentiary disclosure regarding the particle size distribution was found, Weigel et al. “In-line particle size measurement and agglomeration detection of pellet fluidized bed coating by Spatial Filter Velocimetry” published by Powder Technology Volume 301, November 2016, pgs 261-267, which describes the absolute particle distribution of Cellets 1000 as comprising 85% or more have particle sizes 1.000-1.400 mm, ([pg 262 2.1 Materials 1st paragraph]). At least 85% of the particles are four or more times greater than the sieve 0.25 mm, and thus will not pass through it. Of the remaining 15 or less %, some of those particles are going to be greater than 1.4 mm and some will be less. The larger particles will not pass through either.
Applicant may like to argue that the smaller particles might be present in an amount sufficient to exceed the specified limitation. However, there is no evidence to support such an assertion. Such arguments are taken to their logical conclusion, would support a finding that the Applicant’s invention is not enabled across the full scope of their own claims.
Examiner finds such arguments to be unpersuasive, and that the claimed property is a necessary result for a filling material as configured according to modified Bragd that will be true when tested similarly to how Applicant has tested their filling.
First, one of ordinary skill in the art would test the actual size distribution of particles intended for a pouch that is more porous such as that disclosed by Bragd, to ensure the material in the pouch was retained, including both the soluble and insoluble particles. There is evidence in Bragd of such procedures, Bragd describing a grinding and sieving process to result in highly fractionalized tobacco particles, which reasonably suggests that maintaining a particle size that was not too small was required. This supports a finding that the filling material particles are either bound to the MCC or sized to be similar to 1-2 mm. With the filling material so sized, or bound to particles so sized, the property will be necessarily be met because a particle with at least 1 mm size will not pass a hole 0.25mm.
Second, it is further reasonably suggested to one of ordinary skill in the art that all of the components should be retained within the pouch, including the soluble ones, such that the soluble particles are not swallowed and instead are retained to improve the flavor profile and mouthfeel of the pouch in use. Thus, the configuration of the particles to be held within the pouch is obvious, and such a configuration results in the filling material meeting the material property, because one of ordinary skill in the art would size the particles to be at least 1 mm, if that was required to hold the material in the pouch.
Third, Applicants used a smaller average particle size of MCC at 0.945 mm, with an unknown absolute distribution, and when they tested this property on their disclosed sample 1 the property limitation was met, even though the average particle size of the MCC in their test was significantly smaller, pg 12 lines 20-24, see also the results pg 13 table 1, and combined with other particles that have an entirely unknown particle size. There is no evidence that the tightly controlled MCC particles sold under the trade name Cellets 1000 would perform any differently, and it is reasonably suggested because the particle sizes are bigger that less of the Cellets 1000 (if any) would go through a sieve sized 0.25 mm.
Lastly, applying the test procedure Applicant discloses provides experimental results that the particles of MCC would plug the screen and block smaller particles, even if Applicant speculates smaller particles could be present in modified Bragd, from passing the sieve in any appreciable amount.
Applicant testing, and the configuration of the filling material of modified Bragd supports a finding that this limitation is met for a composition made according to Bragd. There is no evidence that Bragd would provide a filling material that would not be contained within the pouch, and a filling material contained by the pouch would not pass the 0.25 mm mesh.
All of Applicant arguments have been fully considered but are unpersuasive.
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) 1-18 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 Weigel et al. “In-line particle size measurement and agglomeration detection of pellet fluidized bed coating by Spatial Filter Velocimetry” published by Powder Technology Volume 301, November 2016, pgs 261-267.
Regarding claims 1, 3, 6, and 9, Bragd discloses:
A pouched product for oral use, ([0032]), comprising
a liquid permeable cover material, ([0033]), and
a filling material comprising one or more water soluble components, ([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])), and
a water insoluble particulate material, the water insoluble particulate material being constituted by water insoluble particles, ([0085] microcrystalline cellulose),
the filling material being enclosed by the liquid permeable cover material, ([0033]),
the filling material comprises one or more water soluble components, ([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])) and
the liquid permeable outer cover material is a nonwoven material having a basis weight in the range of from 10 g/m2 to 28 g/m2, ([0033] a nonwoven with a basis weight of 25 g/m2 at most, such as a range between 20-23 g/m2).
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]), and discloses grinding a sieving the tobacco, ([0107]), which would allow one of ordinary skill in the art to obtain tobacco particles having a tightly controlled particle size.
Bragd does not explicitly disclose the particles of the water insoluble particulate material (microcrystalline cellulose) have an average particle size within the range of from 0.3 mm to 3.0 mm, the filling material contains less than 0.5% of particles passing through a sieve having a mesh size of 250 µm, 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]), the narrower range 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 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]). 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)]).
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 based on the disclosure of Bragd to ensure that the particle distribution of the tobacco was tightly controlled by the grinding and sieving process, to ensure that the tobacco particles if present were retained within the pouch.
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 a source of MCC particles Cellets 1000 where the particle sizes have an average particle size of 1.215 mm +/- 20 µm, which Weigel evidences the absolute particle distribution of Cellets 1000 as comprising particle sizes 1.000-1.400 mm.
It is notoriously well known that particles substantially larger than small holes will not fit through those smaller holes.
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 Cellets 1000 as the microcrystalline cellulose (the water insoluble particulate material) to be used as a carrier for water soluble 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 Cellets brand MCC is particularly advantageous for use in the controlled release active ingredient products, and Soundaranathan teaches an available MCC Cellets 1000 product with a size between 1-2mm. At least 85%+ of Cellets 1000 meet the limitation of a water insoluble particulate material that contains less than 0.5% of particles passing through a sieve having a mesh size of 250 µm, because the size distribution of those particles are all 4 times greater than mesh size of 250 µm.
It is further reasonably suggested to one of ordinary skill in the art that all of the components should be retained within the pouch, including the not only the insoluble particles, but also the soluble ones, such that the soluble particles are not swallowed and instead are retained to improve the flavor profile and mouthfeel of the pouch in use, and the sorbed nicotine is released into the oral cavity of the user. Thus, sizing the particles to be held within the pouch results in the filling material meeting the material property because one of ordinary skill in the art would size the particles to be at least 1 mm, to ensure the material was retained in the pouch, and particles sized at least 1 mm will not pass a 250 micron mesh.
Regarding claim 2, modified Bragd discloses the pouched product of claim 1. Bragd further discloses 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.
Regarding claim 4, modified Bragd discloses the pouched product of claim 3. 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 5, modified Bragd discloses the pouched product of claim 3.
Soundaranathan teaches that the MCC 1000 used in modified Bragd has a particle density of 1.437 g/cm3, ([3.2.1. Swelling data, Table 1]).
Regarding claim 7-8, modified Bragd discloses the pouched product of claim 1. Bragd discloses that the liquid permeable outer cover materal is nonwoven and has an air permeability of above 4,600 l/m2/s when measured according to the EDANA test method WSP070.1.R3(12), ([0049]), overlapping the claimed range and rendering it obvious. Cellets 1000 MCC has an average particle size of 1.215mm, as discussed above.
Regarding claim 10, modified Bragd discloses the pouched product of claim 1.
Soundaranathan teaches that the MCC 1000 used in modified Bragd has a sphericity of 0.94 +/- 0.00, ([3.2.1. Table 1]), and given the relative roundness, that the diameter of the particles is approximately the same as the particle size of 1.215 mm +/- 20 µm, ([3.2.1. Table 1]).
Regarding claim 11, 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 12-13, 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 14-15, 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 claims 16, 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 claims 17-18, modified Bragd discloses the pouched product of claim 16. Nicotine bitartrate is known to be highly soluble in water and MCC is known to have (at least) a different composition than nicotine bitartrate.
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 1-6, and 9-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-10, and 13-15 of copending Application No. 18/255,873. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, 18/255,873 discloses:
a liquid permeable cover material, (claim 1), and
a filling material comprising one or more water soluble components, (claim 1), and
a water insoluble particulate material, (claim 1),
the water insoluble particulate material being constituted by water insoluble particles, (claim 1),
the filling material being enclosed by the liquid permeable cover material, (claim 1),
characterized in that 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),
the filling material comprises one or more water soluble components, (claim 1), and
the liquid permeable outer cover material is a nonwoven material having a basis weight in the range of from 10 g/m2 to 28 g/m2, (claim 15),
the filling material being free from tobacco material, (claim 1), 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, (claim 1). Although the reference application does not explicitly disclose the water insoluble particulate material contains less than 0.5% of particles passing through a sieve having a mesh size of 250 µm, this is considered an obvious characteristic for ranges of particles that all exceed the mesh size of 250 µm by 20%, to ensure that a high proportion of the insoluble particles are retained within the pouch.
Regarding claim 2, 18/255,873 discloses the pouched product of claim 1, the filling material has a pre-use moisture content of from 1% by weight of the filling material to 35% by weight of the filling material, (claim 1).
Regarding claim 3, 18/255,873 discloses the pouched product of claim 1, wherein the water insoluble particulate material comprises water insoluble particles of microcrystalline cellulose, water insoluble starch, silica, or a mixture thereof, (claim 2).
Regarding claim 4, 18/255,873 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 3).
Regarding claim 5, 18/255,873 discloses the pouched product of claim 3, wherein the water insoluble particles have a particle density in the range of from 0.8 g/cm3 to 1.7 g/cm3, (claim 7).
Regarding claim 6, 18/255,873 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, overlapping and rendering obvious the claimed range.
insoluble particles have a particle density in the range of from 0.8 g/cm3 to 1.7 g/cm3, (claim 7).
Regarding claim 9, 18/255,873 discloses the pouched product of claim 1, wherein the liquid permeable cover material is a nonwoven material, (claim 15).
Regarding claim 10, 18/255,873 discloses the pouched product of claim 1. Claim 10 further requires that the water insoluble particles of particulate matter have a sphericity within the range of 0.7-1.0 and a diameter of from 0.3-3.0mm. Although these parameters are not explicitly claimed in US 2024/0041094 A1, ([0101]) discloses an example where the particle size is 445 µm and the sphericity is 0.9 +/- 0.05, reasonably suggesting these parameters would be obvious to one of ordinary skill in the art based on the disclosure.
Regarding claim 11, 18/255,873 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 8).
Regarding claim 12, 18/255,873 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 9).
Regarding claim 13, 18/255,873discloses the pouched product of claim 1, wherein the additive comprises a flavouring agent, (claim 10).
Regarding claim 14, 18/255,873 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 13).
Regarding claim 15, 18/255,873 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 14).
Claims 7-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7-10, and 13-15 of copending Application No. 18/255,873 in view of Bragd et al. (EP 3192380 A1).
Regarding claims 7-8, 18/255,873 discloses the oral pouched product of claim 1. 18/255,873 does not disclose the air permeability of the nonwoven.
Bragd discloses a similar oral pouched product, with a nonwoven having an air permeability that overlaps the claimed range, ([0049]). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the nonwoven of Bragd in the oral pouch product of 18/255,876. In the absence of a disclosure regarding the air permeability of the nonwoven in the base reference, one of ordinary skill in the art would look to the similar pouched product of Bragd, and use a nonwoven with similar attributes, to arrive at a nonwoven with a reasonable expectation of success for use in the pouched product.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4-12 of copending Application No. 18/255,875 in view of Bragd et al. (EP 3192380 A1).
Regarding claim 1, 18/255,875 discloses:
a liquid permeable cover material, (claim 1), and
a filling material comprising one or more water soluble components, (claim 1), and
a water insoluble particulate material, (claim 1),
the water insoluble particulate material being constituted by water insoluble particles, (claim 1),
the filling material being enclosed by the liquid permeable cover material, (claim 1),
characterized in that 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 5),
the water insoluble particulate material contains less than 0.5% of particles passing through a sieve having a mesh size of 250 pm, (claim 6),
the filling material comprises one or more water soluble components, (claim 1), and
the filling material being free from tobacco material, (claim 1), 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, (claim 1).
The reference application does not explicitly disclose the liquid permeable outer cover material is a nonwoven material having a basis weight in the range of from 10 g/m2 to 28 g/m2.
Bragd discloses a similar oral pouched product, with a nonwoven having an air permeability that overlaps the claimed range, ([0049]). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the nonwoven of Bragd in the oral pouch product of 18/255,875. In the absence of a disclosure regarding the air permeability of the nonwoven in the base reference, one of ordinary skill in the art would look to the similar pouched product of Bragd, and use a nonwoven with similar attributes, to arrive at a nonwoven with a reasonable expectation of success for use in the pouched product.
Regarding claim 2, modified 18/255,875 discloses the pouched product of claim 1, the filling material has a pre-use moisture content of from 1% by weight of the filling material to 35% by weight of the filling material, (claim 1).
Regarding claim 3, modified 18/255,875 discloses the pouched product of claim 1, and claims water insoluble particulate material but does not claim the materials comprising the water insoluble particles, in particular that the water insoluble particles comprises microcrystalline cellulose, water insoluble starch, silica, or a mixture thereof. It would be obvious to one of ordinary skill in the art to have selected one of these based on claim 2 of 18/255,873, (claiming that these materials are suitable for the first type of particles which are water insoluble particles, for a similar use).
Regarding claim 4, 18/255,875 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 4).
Regarding claim 5, 18/255,875 discloses the pouched product of claim 3, wherein the water insoluble particles have a particle density in the range of from 0.8 g/cm3 to 1.7 g/cm3, (claim 1).
Regarding claim 6, 18/255,875 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 5), overlapping and rendering obvious the claimed range.
Regarding claims 7-8, 18/255,875 discloses the oral pouched product of claim 1. 18/255,875 does not disclose the air permeability of the nonwoven.
Bragd discloses a similar oral pouched product, with a nonwoven having an air permeability that overlaps the claimed range, ([0049]). It would be obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have used the nonwoven of Bragd in the oral pouch product of 18/255,875. In the absence of a disclosure regarding the air permeability of the nonwoven in the base reference, one of ordinary skill in the art would look to the similar pouched product of Bragd, and use a nonwoven with similar attributes, to arrive at a nonwoven with a reasonable expectation of success for use in the pouched product.
Regarding claim 9, 18/255,875 discloses the pouched product of claim 1, wherein the liquid permeable cover material is a nonwoven material, (claim 12).
Regarding claim 10, 18/255,875 discloses the pouched product of claim 1. Claim 10 further requires that the water insoluble particles of particulate matter have a sphericity within the range of 0.7-1.0 and a diameter of from 0.3-3.0mm. These parameters are claimed in US 18255876, (claim 1 and 8) and it would be obvious to require the particles to be spherical rather than long and narrow, because a non-spherical shape would be more likely to pass through the non-woven.
Regarding claim 11, 18255875 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, (claim7).
Regarding claim 12, 18255875 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 8).
Regarding claim 13, 18255875 discloses the pouched product of claim 1, wherein the additive comprises a flavouring agent, (claim 9).
Regarding claim 14, 18255875 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 10).
Regarding claim 15, 18255875 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 11).
This is a provisional nonstatutory double patenting rejection.
Claims 1-15 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. 18255876. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, 18255876 discloses:
a liquid permeable cover material, (claim 1), and
a filling material comprising one or more water soluble components, (claim 15), and
a water insoluble particulate material, (claim 1),
the water insoluble particulate material being constituted by water insoluble particles, (claim 1),
the filling material being enclosed by the liquid permeable cover material, (claim 1),
characterized in that 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 5),
the water insoluble particulate material contains less than 0.5% of particles passing through a sieve having a mesh size of 250 pm, (claim 2),
the filling material comprises one or more water soluble components, (claim 15), and
the filling material being free from tobacco material, (claim 1), 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, (claim 1),
and the liquid permeable outer cover material is a nonwoven material having a basis weight in the range of from 10 g/m2 to 30 g/m2, (claim 8), overlapping the claimed range.
Regarding claim 2, 18255876 discloses the pouched product of claim 1, the filling material has a pre-use moisture content of from 1% by weight of the filling material to 35% by weight of the filling material, (claim 1 disclosing an overlapping range).
Regarding claim 3, 18255876 discloses the pouched product of claim 1, and claims water insoluble particulate material but does not claim the materials comprising the water insoluble particles, in particular that the water insoluble particles comprises microcrystalline cellulose, water insoluble starch, silica, or a mixture thereof. It would be obvious to one of ordinary skill in the art to have selected one of these based on claim 2 of 18/255,873, (claiming that these materials are suitable for the first type of particles which are water insoluble particles, for a similar use).
Regarding claim 4, 18255876 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, 18255876 discloses the pouched product of claim 3, wherein the water insoluble particles have a particle density in the range of from 0.8 g/cm3 to 1.7 g/cm3, (claim 1).
Regarding claim 6, 18255876 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 and rendering obvious the claimed range.
Regarding claims 7-8, 18255876 discloses the oral pouched product of claim 1, wherein the water permeable outer cover material has an air permeability of from 4,000 1/m2/s to 10,000 1/m2/s, when measured according to the EDANA test method WSP070. 1.R3(12), (claim 7) overlapping the claimed ranges.
Regarding claim 9, 18255876 discloses the pouched product of claim 1, wherein the liquid permeable cover material is a nonwoven material, (claim 9).
Regarding claim 10, 18255876 discloses the pouched product of claim 1. Claim 10 further requires that the water insoluble particles of particulate matter have a sphericity within the range of 0.7-1.0 and a diameter of from 0.3-3.0mm, (claim 3-4).
Regarding claim 11, 18255876 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 12, 18255876 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 13, 18255876 discloses the pouched product of claim 1, wherein the additive comprises a flavouring agent, (claim 14).
Regarding claim 14, 18255876 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 15, 18255876 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael H. Wilson can be reached at (571) 270-3882. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.E.V./Examiner, Art Unit 1747
/Michael H. Wilson/Supervisory Patent Examiner, Art Unit 1747