DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1, 3, 6, 9, 14-15, 31, 34, 37, 51, and 59 are pending. Claims 2, 4-5, 7-8, 10-13, 16-30, 32-33, 35-36, 38-50, and 52-58 are cancelled. Claims 1 and 59 are amended.
Response to Amendment
The Response of 5/16/2025 has been entered. The amendment to the Specification overcomes each and every objection to the Specification, and thus these objections are withdrawn.
Response to Arguments
Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive.
Applicant's amendment necessitated any 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). Applicant amended several limitations into the base claims that were not previously considered together, and added a new weight limitation regarding the weight percentage of the at least one sugar alcohol present. These amendments required changes to the rejections below.
The page numbers of the filed amendment were not visible. Pagination of the Remarks for citation purposes will start with the page having the heading “SUPPORT FOR THE AMENDMENTS” considered to be page 1, with subsequent consecutive pages increasing by 1, such that final page ends with the page having the heading “Conclusion” considered to be page 8.
The prior art referenced in the rejections below render the claimed compositional limitations obvious. The compositional limitations are considered to inherently provide the claimed functional limitations. Arguments previously made by Applicant raise a legitimate question as to whether this is inherently true. The amended claims do not cure the 35 USC 112(a) Scope of enablement rejections made in the prior office action of 08/19/2025.
Claim 8 was cancelled by amendment, but previously recited: The pouch composition according to claim 1, wherein the inorganic divalent cation is provided as a salt in an amount of between 0.1 and 15.0% by weight of the composition.
Claim 16 was cancelled by amendment, but previously recited: The pouch composition according to claim 1, wherein the pouch composition comprises the mixture of nicotine free base and polacrilex resin in an amount of 0.1 to 20% by weight of the pouch composition.
Claims 26-27 were cancelled by amendment, but previously recited: The pouch composition according to claim 1, wherein the pouch composition further comprises at least one sugar alcohol. (claim 26). The pouch composition according to claim 26, wherein the at least one sugar alcohol is selected from xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, lactitol, and mixtures thereof. (claim 27).
The inclusion of these limitations together in a single claim was not previously considered. Additionally, the limitation requiring 5-60% by weight of the at least one sugar alcohol, further limiting the sugar alcohol limitations from claims 26-27 was not previously considered.
Applicant asserts that Kindvall does not disclose or suggest compositions containing sugar alcohols in a weight % of between 5-60%, (Remarks pg 5 last full paragraph). Applicant is reading the disclosure of Kindvall too narrowly. Kindvall discloses that the pouch comprises particulate non-tobacco material in a range from about 30 wt% to about 90 wt%, ([pg 14 lines 16-17]), and that the particulate non-tobacco material may comprise or consist of a sugar alcohol, further suggesting an exemplary sugar alcohol such as maltitol, ([pg 14 lines 26-27]). This disclosure reasonably suggests that a range of weight percentages of sugar alcohol can be used, including embodiments where the particulate non-tobacco material may consist of 30-90% by wt of sugar alcohol, and where the particulate non-tobacco material may comprise an unknown wt% of sugar alcohol, where the embodiment comprises 30 wt% to about 90 wt% total particulate non-tobacco material. This disclosure reasonably suggests using sugar alcohol in an amount of 30% or more as a sweetener. One of ordinary skill in the art would understand that different users would like their pouch composition more or less sweet and adjust the weight percentage of the sugar alcohol accordingly. Neither the claimed range of sugar alcohol, nor the type of sugar alcohol is patently inventive over Kindvall.
Applicant suggests that there is disclosure regarding the effective release rates of claims 1 and 59, (Remarks pg 3 middle paragraph), and points to the disclosure at ([00277] which begins the disclosure regarding the preparation of a number of nicotine premixes) of the present Specification, asserting the claims are directed towards a unexpectedly synergistic effective release rate of nicotine from the polacrilex resin, because of the presence of the divalent cation and sugar alcohol.
The entirety of disclosure has been thoroughly reviewed. There is no disclosure showing the effective release rate of the claimed composition at the conditions as required by the claim.
The present Specification provides release rate data for CaCL2 at 25 degrees Celsius and stirring of 100 rpm, where the pH was below 7.0 at the start and end of the experiments, NPR (16%), ([00442]-[00447] comparing release rates of CaCl2 against NaCl), release rates of nicotine for CaCL2 at 25 degrees Celsius and stirring of 100 rpm, where the pH was below 7.0 at the start and end of the experiments, NPR (16%), ([00448]-[00451] comparing the effect of different molar equivalents of CaCl2 on the release rate at various time points), release rates of nicotine for MgCL2 at 25 degrees Celsius and stirring of 100 rpm, where the pH was below 7.0 at the start and end of the experiments, NPR (16%), ([00453]-[00456] comparing the effect of different molar equivalents of MgCl2 on the release rate at various time points).
These release rate experiments do not disclose the percentage of nicotine compared to polacrilex resin, and thus do not form the basis for determining the release rates of claimed compositions.
Further, these experiments do not show the release rates for the pouches with the other components of the pouch composition as claimed, only showing the release rate of NPR 16% against molar amounts of the divalent cation. While other experiments included show a release rate for a number of premixes, ([00461]), the experimental data was done at a stirring rate of 150 rpm, does not show the time point of 20 minutes, and does not disclose the impact of other components in the pouch.
Applicant did provide some pouch release experiments starting at ([00468-[00475] pouch release experiments), but the disclosed experiments neither correspond to the claimed compositional limitations nor can the release rate data be correlated to the claimed functional limitations.
Applicant admits that the additional components of the pouch will affect the release rate, asserting that certain components will have a synergistic effect on the release rate, (Remarks page 6, describing a synergistic effect of the combination of Ca or Mg salt and the recited sugar alcohols providing enhanced nicotine release). There does not appear to be any disclosure of an unexpected effect of the combination of the pouch compositions, in the amounts claimed, upon which a finding of an unexpected result regarding nicotine release rates can be made.
Applicant is reminded that the functional limitation that is claimed is not based on saliva production in a user’s mouth. Applicant chose to claim the release rate under specific test conditions. There is evidence that sugar alcohol would impact the release rate claimed, but the release rate is expected to be modified based on how the sugar alcohol is added to the pouch composition and how the sugar alcohol directly interacts with the resin. No saliva is expected to be produced under the claimed test conditions, and thus the well known interaction of sweet taste as stimulating saliva production, (Pederson [pg 1405 first full paragraph]) does not impact the release rate which is claimed under test conditions that do not include salivary glands.
The cited prior art reasonably suggests the using the claimed components in amounts that read on the claimed pouch composition. The prior art reasonably suggests that the claimed components varied across the claimed amounts will impact the claimed release rate, and the finding that that the claimed release rate will not be enabled across the full scope of claimed compositions is maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 6, 9, 14-15, 31, 34, 37, 51, and 59 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a pouch composition having the compositional limitations of the claims, does not reasonably provide enablement for “an effective release of nicotine into water at 25°C is 70% or higher after 20 minutes at a concentration of 28 mg/L and a stirring rate of 100 rpm”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
Claim 1 and claim 59 include limitations that partially define a composition of matter, and a defined release rate of that composition, which recites: “an effective release of nicotine into water at 25°C is 70% or higher after 20 minutes at a concentration of 28 mg/L and a stirring rate of 100 rpm”.
The effective release of nicotine into water at 25°C after 20 minutes at a concentration of 28 mg/L and a stirring rate of 100 rpm for the compositions of matter defined by the claims under examination is an inherent property of the composition.
In the Final Rejection of 01/17/2025, the release rate of 70% or higher was asserted as inherently present for all compositions as defined by the claims. Applicant argues that the recited release rate is not inherent to the compositions made obvious by Kindvall, because Kindvall does not disclose the ratios of the components in the same way that have been claimed, Remarks pg 11, last full paragraph.
Although the rejections below demonstrate that the disclosure and teachings together with the ordinary skill in the art render the claimed compositions obvious, the assertion that the claimed release rate is not met by the obvious compositions of modified Kindvall raises a serious question as to whether the claimed release rate is enabled by the Specification for the full scope of the claimed invention.
The enablement requirement refers to the requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph that the specification describe how to make and how to use the invention. The invention that one skilled in the art must be enabled to make and use is that defined by the claim(s) of the particular application or patent.
MPEP 2164 The Enablement Requirement.
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. See also In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
MPEP 2164.01 Test of Enablement.
In Amgen Inc. et al. v. Sanofi et al., 598 U.S. 594, 2023 USPQ2d 602 (2023), the Supreme Court, held that claims drawn to a genus of monoclonal antibodies, which were functionally claimed by their ability to bind to a specific protein, PCSK9, were invalid due to lack of enablement. The claims at issue were functional, in that they defined the genus by its function (the ability to bind to specific residues of PCSK9) as opposed to reciting a specific structure (the amino acid sequence of the antibodies in the genus). The Supreme Court concluded that the patents at issue failed to adequately enable the full scope of the genus of antibodies that performed the function of binding to specific amino acid residues on PCSK9 and blocking the binding of PCSK9 to a particular cholesterol receptor, LDLR.
The Court clarified that the specification does not always need to "describe with particularity how to make and use every single embodiment within a claimed class." Id. at 610-11. However, "[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class….The more one claims, the more one must enable." Id.
Id.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue."
MPEP 2164.01(a) Undue Experimentation Factors.
Thus, to assess whether the claims require undue experimentation the “Wands Factors are assessed.
(A) The breadth of the claims
Regarding the breadth of the claims:
In all claims the intended use of the composition is a pouch composition.
The compositional limitations require:
a mixture of nicotine free base and polacrilex resin,
from 0.1 to 20% by weight of the pouch composition of a mixture of nicotine free base and polacrilex resin,
the mixture of nicotine free base and polacrilex resin comprises from 10% to 30% by weight of the nicotine free base and from 70% to 90% by weight of the polacrilex resin;
water in an amount of at least 15% by weight of the pouch composition;
a sugar alcohol in an amount of 5 to 60% by weight relative to the pouch composition of at least one alcohol selected from the group consisting of xylitol, maltitol, mannitol, erythritol, isomalt, sorbitol, and lactitol and,
from 0.1 to 15% by weight relative to the pouch composition of a salt an inorganic divalent cation selected from calcium and magnesium, wherein a molar ratio of the inorganic divalent cation relative to the nicotine free base in the mixture of nicotine free base and polacrilex resin is from 0.75 to 4.0.
Claims 1 and 59 differ in that claim 1 further requires a composition modifier selected from the group consisting of silicon dioxide, starch and talc, whereas claim 59 further requires a water-insoluble fiber; a sugar alcohol; a flavor, and a total content of the water-insoluble fiber, sugar alcohol and flavor is 50% by weight or more of the pouch composition.
Neither claim provides a weight amount for the nicotine free base. Neither claim provides a weight amount for the polacrilex resin. The claims use the open form of the transition, “comprising”, thus both claims are open to the inclusion of a potentially infinite additional number of components in an infinite number of ranges, so long as the broad limitations regarding the components that are specified by limitations are respected, such that the amounts of inorganic divalent cation selected from calcium and magnesium, and the amounts of combined nicotine free base and polacrilex resin meet the limitations that define the amounts of these with respect to each other.
Because the claims allow for an infinite number of compositions, the claims are considered exceptionally broad, covering an infinite number of compositions, both in terms of component compositions and the specific weight percents of those components in the composition, and weight amounts of the components in a pouch. Additionally, the method of making the composition is not specified, leaving open another aspect of the composition, further increasing the breadth of the claims.
Because there is an infinite number of compositions, with infinite unknown components, and the known components cover an infinite number of weight percentages, tied only by broad limitations with regard to their proportions in terms of each other, the breadth of these claims is infinite.
(B) the nature of the invention
The nature of the invention is considered to be an oral pouch composition designed to release nicotine for a user, such as part of a nicotine replacement therapy for a smoker, and such that the pouch composition is designed to release nicotine over a period of time, with an expected effect that the user desire to smoke is curbed, and the user is provided with an acceptable taste and mouthfeel, without significant irritation to the oral cavity and membranes and otherwise meeting accepted standards of toxicity. The nature of the invention implies a release rate that meets or exceeds the claimed functional limitation, and there are many examples of pouches that meet this limitation in the prior art.
(C) The state of the prior art
The state of the art recognized the advantages and disadvantages of compositions using nicotine free base complexed with polacrilex resin, and the use of inorganic divalent cations selected from calcium and magnesium. Composition modifiers that included silicon dioxide, starch, and talc were recognized, as was the use of water in the compositions. The state of the art generally recognized identifying the components of the compositions, and specifying relative weight percentages or weight amounts, and the state of the art recognized that different components in the composition, and the order in which the components were added, could have significant impact on release rates. Several references discuss release rates for similar compositions, and many compositions have a similar use which suggests that the compositions would be selected with a similar release rate, and suggests a release nicotine rate of at least 70% within ten minutes for an oral pouch used in smoking cessation therapy, Franz (US 2011/0207782 A1), which is considered an obvious use of the claimed composition.
The state of the prior art recognized controlling the release rate of nicotine by controlling the supply of water in the form of saliva to the matrix composition, to obtain a modified release, (Bruun [0058]), a matrix composition may be nicotine polacrilex resin (Bruun [0025]). Bruun teaches a number of embodiments using different carriers for the nicotine, with or without polacrilex resin, and in embodiments where sugar alcohol is not used as a carrier it may be used as a sweetener, (Bruun [0037]), and the stimulation of salivary glands due to sweet tasting compositions was known, (Pederson [1405 first full paragraph]).
(D) The level of one of ordinary skill
The level of ordinary skill in the art is understood to be a person with knowledge and understanding regarding the design of nicotine oral pouch compositions, with the ability to select the weight percentage of each component for an oral pouch composition comprising: nicotine free base; polacrilex resin; inorganic divalent cations selected from calcium and magnesium; a composition modifier comprising silicon dioxide, talc, and starch; the weight percentage of water within a range of 15 or more of the composition; and the weight percentage of any other component added.
One of ordinary skill in the art would be capable of calculating whether or not the weight percentages of components together meet the compositional limitations of the claims and one of ordinary skill in the art would be capable of testing such the composition to determine whether the release rate of nicotine by the composition meets the functional limitation of the claims.
However, due to the interaction of the various components of the composition with the resin, and the loading and release rate from the resin, as well as the interaction of the method of making the composition with the release rate of the nicotine by the resin, one of ordinary skill in the art would not be able to reliably predict the release rate of the nicotine, such that testing would be required to determination if the release rate limitation was met for each unique composition.
(E) The level of predictability in the art
The binding of nicotine free base to polacrilex resin was well understood. The use of cations to block binding sites on the resin and displace nicotine from binding sites was also well understood. The concept and importance of molar amounts of components, where interaction between components is based on the molar mass of each of the components, is considered a basic principle of chemistry applicable across a variety of products, and the application of this concept was also well understood. The method of varying one molar amount in relation to the others, to drive a reaction – including loading and desorption from a resin, was well understood. The interaction of other substances, such as polyols with the resin was known. Interactions based on the steps/method of forming the compositions were known. The unpredictability of the art is considered predictable, (see Bruun [0186]-[0190] describing results were inconsistent with predicted expectations for release rates of pouches); One of ordinary skill in the art would expect there to be unknown variability in new compositions with unspecified methods of forming the compositions, such that testing would be required to determine the effective release rate of the nicotine free base from the resin for each composition.
(F) The amount of direction provided by the inventor and (G) The existence of working examples
The inventor has provided release testing of some premixes see Table 22, 23, 24.
Table 25 shows some additional testing for different premixes of NPR released with a mixture of 1eq of CaCl2.
The inventor has provided tables that suggests for any particular NPR nicotine loading %, the water and resin % may variable, see ([00279]-[00286]).
Applicant provided many examples of pouch compositions, ([00294]- [00433] P01-P127). Many of these compositions appear to meet the compositional limitations of the claims, but many do not. The molar amounts nicotine, resin wt%, are not provided, no way of correlating the release rates to the ratios and weight percentage relationships is provided in the Specification, though see table 13 ([00338], table 27 ([00475]), where some release rate and composition data was provided.
No testing of release rates for pouch compositions matching the claimed compositions under the claimed functional release conditions were provided, thus no example of a composition that meets the compositional limitations that meets the functional required property.
Specification does not provide direct guidance on the selection of pouch components, their weight percentages, or the order and method of adding the components together, such that the functionally required property is achieved. Nowhere in the Specification is it shown how modifying the various compositional limitations, will increase, decrease, or even reliably influence the release rate under the claimed conditions.
The Specification does provide guidance on how to test the compositions to determine the release rate.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure
One of ordinary skill in the art would be able to immediately make a pouch composition that meets the compositional claim limitations, by determining whether the disclosed pouch compositions meets the compositional claim limitations, (because the Specification does not disclose the composition make up in terms of the claimed compositional limitations, one would have to look up molar and otherwise determine molar mass of components, use basic chemistry calculations to determine the molar relationships of the cation to nicotine, and determine the weight percent of the resin compared to the nicotine freebase), then select a composition that meets the compositional limitations, make the composition according to the disclosed method (because the method and order of making the composition is understood from the prior art to affect the release rate). One of ordinary skill in the art could then test the composition to confirm the functional release rate limitation is met. One of ordinary skill in the art would be able to vary the various compositional limitations and determine through experimentation how each variable changes the release rate as each compositional limitation is varied. Reasonably, at least for some compositions, the disclosure provides a fairly defined composition and method of making that composition, and the release rate information strongly suggests that the claimed the release rate would be met for at least some compositions that meet the compositional claim limitations.
Thus, there is little question that at least some claimed compositions are enabled by the Specification.
But, because it is expected that the introduction of different components into the composition will influence the release rate, compositions made by different methods are expected to have different release rates, and some of the claimed compositions were argued to not inherently meet the claimed release rates, the amount of experimentation required to determine the full scope of the claim as limited by the functional release limitations is infinite, and thus the level of experimentation to determine the full scope of the invention is undue.
Examiner respectfully suggests that this rejection may be overcome by removing the limitation “wherein an effective release rate of nicotine into water at 25 C is 70% or higher after 20 minutes at a concentration of 28 mg/L and a stirring rate of 100 rpm”.
Claims 3, 6, 9, 14-15, 31, 34, 37, and 51 are also rejected as dependent on a base claim that is rejected because the scope of the claim is not fully enabled.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, 6, 9, 14-15, 31, 34, 37, and 51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kindvall (WO 2020/157280 A1)(IDS 07/22/2021), and further in view of Joyce et al. (US 2022/0225660 A1)(provisional filing date relied upon to establish priority), Bruun (US 2019/0255035 A1), Pederson et al. “Salivary Functions”, Oral Diseases pg 1399-1416, March 30, 2018, Walling (US 2003/0224048 A1), Anderson I (US 2014/0230833 A1), Anderson II (US 2013/0071338 A1), and as evidenced by Amberlite IRP64 Pharmaceutical Grade Ion Exchange Resin (Polacrilex Resin)(PTO-892 dated 01/17/2025).
Regarding claim 1, 3 and 51, Kindvall discloses:
an oral pouched product, ([pg 3 line 11 - pg 4 line 22], [pg 27 line 7 - pg 29 line 15] items 1, 2, or 3);
a nicotine source in the pouch, ([pg 3 line 15]), the nicotine source may be a nicotine base, ([pg 15 line 7]), the nicotine base may be bound to an ion exchange resin, such as polacrilex, ([pg 15 line 7-10], [pg 33 lines 1-3], item 30);
the nicotine source may be present in the range of about 1% to 10% by weight, ([pg 32 lines 32-35], item 29), thus disclosing that the composition may comprise nicotine free base in a range of 1% wt to 10% wt.
Thus, by disclosing that the nicotine source may be a nicotine base bound to an ion exchange resin such as polacrilex, Kindvall necessarily discloses the composition comprises nicotine free base in a weight% range of nicotine free base to a weight % range of the polacrilex resin, but leaves the selection of the relative weight% ranges to one of ordinary skill in the art;
water in an amount within the range of 1 wt% to 45 wt%, ([pg 3 lines 16-17]), with
an alternative, having a higher and narrower range from 20 wt% to 50 wt%, ([pg 11 line 31-32], [pg 30 lines 17-19] item 12);
a salt (having a cation), of Formula (I), ([pg 3 lines 20-23]), where M2+ is selected from a group that consists of Ca, Mg, Mn, Zn, and Fe, ([pg 3 line 25]), identifies an embodiment where the M2+ Ca or Mg, ([pg 31 lines 4-5], item 16), and an embodiment where the is provided in CaCl2, ([pg 31 lines 10-11] item 18);
the composition comprises the salt by wt% in a range from 0.05 wt% to 10%, ([pg 12 lines 9-11]), with an embodiment disclosing a narrower range of 0.05 wt% to 7%, ([pg 28 lines 15-17) item 2), and an embodiment where the specified range of the salt is between 0.05 wt% to 5 wt%, ([pg 30 lines 21-22] item 13);
thus, Kindvall is considered to disclose an embodiment where the cation is provided in CaCl2 in wt% range of between 0.05 wt% to 5 wt%, and the nicotine source is nicotine freebase provided in a wt% range of between 1% to 10 % by weight, the molecular weight (MW of nicotine freebase is 162.23 g/mol, the MW of CaCl2 is 110.98 g/mol, dividing each of the wt% by the respective MW will give a mol%, which gives an average mol % of nicotine free base of 0.0339 and an average mol% of CaCl2 of 0.0228, and a ratio of the CaCl2 to nicotine freebase of 1.49, demonstrating that the disclosed embodiment overlaps the claimed ratio and wt% range, rendering these ranges obvious;
Kindvall discloses that the filling material may comprise a particulate non-tobacco material, ([pg 3 line 14]), explicitly disclosing that the non-tobacco particle material may be sugar alcohol, ([pg 14 line 26-29]), and water insoluble fiber, ([pg 15 line 1-2],[pg 32 lines 22-30] embodiments comprising item 27 and 28 include water insoluble fiber), ([pg 32 lines 13-19], embodiments comprising item 25 and 26 both disclosing the composition comprises a sugar alcohol. Kindvall discloses that the pouch comprises particulate non-tobacco material in a range from about 30 wt% to about 90 wt%, ([pg 14 lines 16-17]), and that the particulate non-tobacco material may comprise or consist of a sugar alcohol, further suggesting an exemplary sugar alcohol such as maltitol, ([pg 14 lines 26-27]). This disclosure reasonably suggests that a range of weight percentages of sugar alcohol can be used, including embodiments where the particulate non-tobacco material may consist of 30-90% by wt of sugar alcohol, and where the particulate non-tobacco material may comprise an unknown wt% of sugar alcohol, where the embodiment comprises 30 wt% to about 90 wt% total particulate non-tobacco material. This disclosure explicitly suggests using sugar alcohol comprising maltitol as a sweetener.
Kindvall does not explicitly disclose that the particulate non-tobacco material comprises starch, but it is understood that many of the plant fiber types will include at least some starch of these types. Kindvall does not disclose that the particulate non-tobacco material may additionally comprise silicon dioxide, or talc. Kindvall also does not disclose the wt% range of nicotine base compared to the wt% range of polacrilex resin.
Joyce teaches a pouched product adapted for release of a water-soluble component therefrom, ([0011]), and is therefore considered to be prior art within the Applicant’s field of endeavor. Joyce teaches that pouches typically include at least one particulate filler component, which may fulfill multiple functions including enhancing organoleptic properties such as texture and mouthfeel, and enhancing cohesiveness or compressibility of the product, ([0088]), which may include derivatives of non-tobacco material including starches, with example starches including potato, wheat, and corn, ([0088]). Joyce teaches that starch may refer to pure starch from any source, modified starch, or starch derivatives, and that starch is present, typically in granular form, in almost all green plants and in various types of tissues and organs, with examples of seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains, and stems, ([0089]). Many of the starch sources listed in Joyce overlap with fiber types disclosed in Kindvall above, including maize, oat, barley, root vegetables, buck wheat, wheat, pea, potato, rye, and fruit, ([0089] suggesting that similar fiber types of Kindvall may already comprise at least some of these starches and further suggesting that starch types that are similar to fiber types disclosed by Kindvall would be acceptable choices to provide the benefits taught by Joyce.
Bruun teaches a pouch designed for the administration of an active ingredient in the oral cavity, ([0005]), and is therefore considered to be prior art within the Applicant’s field of endeavor. Bruun teaches that it is advantageous to include a release controlling composition within the oral pouch, ([0057]), and that by controlling the release of nicotine by means of controlling the supply of water in the form of salvia to the composition, a modified release may be obtained, ([0058]), teaching that the release controlling compositions include silicate dioxide and talc, ([0059]), and that in an advantageous embodiment the release controlling composition may be used in an amount between 1 and 20 wt% of the composition, ([0069]). Bruun teaches the matrix composition may be nicotine polacrilex resin ([0025]). Bruun teaches a number of embodiments using different carriers for the nicotine, with or without polacrilex resin, and in embodiments where sugar alcohol is not used as a carrier it may be used as a sweetener, (Bruun [0037]). Bruun teaches that sugar alcohol may be used as a sweetener in a range that is preferably between 20% to 98% of the weight of the pouch, ([0111]-[0112]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Kindvall by including starch, silicate dioxide, or talc in the pouch composition, as taught by Joyce and Bruun. Joyce teaches the addition of starch will provide advantages such as enhancing organoleptic properties such as texture and mouthfeel, and many of the disclosed starch types are also fiber types disclosed by Kindvall, reasonably suggesting to one of ordinary skill in the art high compatibility and likelihood of success in using any of the similar starch types. Bruun teaches that adding silicate dioxide or talc will help control the release of nicotine by the composition and suggests a range from 1% to 20% by wt of their use. One of ordinary skill in the art would have had a reasonable expectation of success in adding starch, silicon dioxide, or talc to obtain the advantages taught by the references, because the reference are within the same field of endeavor and Kindvall leaves open the possibility of other types of particulate non-tobacco material by not explicitly excluding the addition of other types.
Pederson teaches salivary functions related to taste, including that the presence of food results in an increased output of saliva, ([pg 1399 1. Introduction]), and is thus reasonably pertinent to the problem faced by the inventor because controlling the supply of water in the form of saliva was a known method of controlling the release of nicotine taught by Bruun. Pederson teaches that the stimulation of salivary glands due to sweet tasting compositions was known, ([pg 1405 first full paragraph]).
Walling teaches a process for producing a product having a nicotine release rate of at least 70% over a 10 minute period, ([0002]), and is thus within the Applicant’s field of endeavor. Walling teaches that cationic ion exchange resins are well known in the art and include a variety of Amberlite resins including Amberlite IRP-64, ([0017]). Walling teaches including an organic polyol in the composition, and teaches examples of known organic polyols include sorbitol, ([0018]), which meets Applicant’s type of required sugar alcohol. Walling does not teach the weight percentage of sugar alcohol required to achieve the not less than 70% nicotine release rate over a period of 10 minutes. Instead, Walling teaches that the ratio of cation exchange resin (polacrilex resin) to polyol is from about 1:1 to about 5:1, and a preferred ratio of nicotine to cation exchange resin is about 4 to 1, ([0021]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the amount of sugar alcohol in the form of maltitol as disclosed by Kindvall, or sorbitol as taught by Walling, to arrive at an amount of sugar alcohol in a range of 5% to 60% by weight, by adjusting the amount of sugar alcohol to arrive at a desired sweetness and provide an effective release rate of greater than 70% over a period of ten minutes, as taught by Walling, by providing a nicotine source in a range of 1-10%, as disclosed by Kindvall, and a corresponding cation exchange resin in a wt% amount of 4-40%, provided based on the ratio taught by Walling, and a wt% of sugar alcohol of 4%-40%, provided by the ratio taught by Walling, substantially overlapping the claimed range and rendering ranges within the 5% to 40% by wt of sugar alcohol in the form of maltitol, sorbitol, or equivalent sugar alcohols obvious to select to achieve a release rate of at least 70% in ten minutes.
Anderson I teaches nicotine delivery product comprising a cationic exchange resin, with a polyol, having a high nicotine release rate, ([0009]. [0011]) and is thus considered within the Applicant’s field of endeavor. Anderson I teaches a preferred cation exchange resin is polacrilex ion exchange resin, Amberlite IRP64, ([0029]). Anderson I teaches that the polyol may be several types including maltitol, ([0033]-[0036]). Anderson I teaches that the nicotine product has a high nicotine release rate of not less than 80% over a period of 10 minutes, ([0020]), and offers an explanation of why the release rate is so high, ([0022]). Anderson I teaches that in a product without polyol, the binding between nicotine and the cationic resin is dominated by ionic bonds, ([0023]), but that when the added polyol is present the polyol penetrates deeper into the resin particles before the loading of nicotine, such that the polyol will be concentrated in the center of the resin, and the nicotine will be concentrated on the surface, ([0024]-[0025] suggesting the nicotine is released more quickly because it is concentrated on the surface). Anderson I teaches a preferred water content of between 15-65 wt%, ([0039], and Anderson teaches that the weight ratio or the cationic ion exchange resin to nicotine is most preferably 4:1, ([0038] which provides a weight ratio of nicotine in an amount of 20% by weight to Amberlite IRP64 in an amount of 80% by weight, which meets the claimed limitation).
Anderson II teaches a method of producing a nicotine delivery product comprising a cation exchange resin, nicotine, and water, ([0011]), and thus is considered to be within the Applicant’s field of endeavor. Anderson II teaches a preferred amount of water is between 15-65 wt.%, more preferably 20-55 wt%, and most preferably between 25-45 wt%, and that preferably the water content is selected to avoid the use of a drying step to save energy, ([0024]-[0025]). Anderson II teaches that nicotine is an essential component of the mixture and that the preferred nicotine is in the form of nicotine base, ([0027]), with a concentration of nicotine in the mixture preferably between 5 and 50% by weight of the mixture, ([0028]). Anderson teaches that the weight ratio or the cationic ion exchange resin to nicotine is most preferably 4:1, ([0038] which provides a weight ratio of nicotine in an amount of 20% by weight to Amberlite IRP64 in an amount of 80% by weight, which meets the claimed limitation).
Amberlite evidences a polacrilex resin that is used commercially for the sustained release of nicotine, ([pg 1 heading identifier and first paragraph under description including bullet points]), and thus is considered prior art because it is within the Applicant’s field of endeavor. Amberlite evidences that the amount of drug loaded onto amberlite will be influenced by such factors as the affinity between the ion exchange resin and the drug, the concentration of the drug in the loading solution, the concentration and selectivity of competing cations, and the pH of the loading solution. ([pg 3, the section under Drug loading]). Amberlite evidences the rate and completeness of drug desorption will be controlled by the diffusion rate of the drug through the polymer phase of the resin, the selectivity of the drug for the resin, the concentration of electrolytes in the desorption environment, and that other resin-sorbate interactions are possible, indicating that these can have a pronounced effect on loading capacities and rates, ([pg 3 paragraphs under drug release]).
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 Kindvall according to the teachings of Anderson I & II. Kindvall discloses the wt% range of nicotine base, but not the wt% range of polacrilex, thus leaving the selection of the relative weight% ranges to one of ordinary skill in the art. Anderson I & II, both suggest the nicotine wt% to polacrilex resin should be preferably 20% nicotine to 80% polacrilex resin, with Anderson II teaching that the nicotine source should be nicotine base, and both Anderson I & II teaching that the water content should be in a range of 15-65 wt%; Anderson II teaching that the water content should be selected such that drying is not necessary, which is compatible with the 20-50 wt% range of water disclosed by Kindvall. Because Anderson I & II suggest compositions compatible with Kindvall, and further disclose a preferred relative wt% of nicotine to wt% of polacrilex resin, it is reasonably suggested to one of ordinary skill in the art to use 20 wt% of nicotine base to 80% wt of Amberlite IRP64 resin, and one of ordinary skill in the art would have a reasonable expectation of success in using these weight percents based on the release rates taught by Anderson I. This also renders obvious the limitation of the combined wt% of nicotine free base and polacrilex resin because Kindvall 1-4 wt% of nicotine base falls within the suggested range of Kindvall, and teachings of Anderson I & II suggest the amount of polacrilex resin for this range of nicotine free base is 4-16 wt%, thus rendering obvious a range of nicotine free base and polacrilex resin in the range of 5% to 20% which meets the claimed range of 0.1 to 20 wt%.
Modified Kindvall does not disclose the effective release of nicotine into water at 25 °C is 70% or higher after 20 minutes at a concentration of 28 mg/L and a stirring rate of 100 rpm. Amberlite evidences that the rate and completeness of drug desorption will be controlled by the diffusion rate of the drug through the polymer phase of the resin, the selectivity of the drug for the resin, the concentration of electrolytes in the desorption environment, and that other resin-sorbate interactions are possible, indicating that these can have a pronounced effect on loading capacities and rates, ([pg 3 paragraphs under drug release]). Modified Kindvall has a cation selected from calcium and magnesium, and the cation is present within the claimed molar ratio. Modified Kindvall has an amount of nicotine base and polacrilex resin in an amount that falls within the claimed relative amounts. Modified Kindvall has a composition modifier that may include silicon dioxide and talc, known to be release controlling compositions. Modified Kindvall has water in an amount of 20-50 wt%. Thus, modified Kindvall comprises all of the compositional limitations that are expected to give rise to the claimed the functional limitations. MPEP 2173.05(g) Functional Limitations. “Unlike means-plus-function claim language that only applies to purely functional limitations, Phillips v. AWH Corp., 415 F.3d 1303, 1311, 75 USPQ2d 1321, 1324 (Fed. Cir. 2005) (en banc) ("Means-plus-function claiming applies only purely functional limitations to that do not provide the structure that performs the recited function."), functional claiming often involves the recitation of some structure followed by its function. One of ordinary skill in the art would understand a common use of the modified pouch composition would be as a nicotine replacement therapy, and that a release rate for an oral dose nicotine drug product should have a release rate of greater that 70% in 10 minutes for this obvious use. Thus, one of ordinary skill in the art would be motivated to check for compositions disclosed by the prior art and select compositions that meet this release rate for this purpose.
Here, many of the claimed limitations are understood in the context of the prior art references and the ordinary skill in the art as providing the claimed functional release rate. Because modified Kindvall renders the claimed compositional limitations obvious, and those compositional limitations are understood to provide a composition for products designed to meet the functional limitation, because one of the uses for oral nicotine pouches is to provide nicotine therapy to smokers, thus the functional limitations are met.
Regarding claim 6, 9 and 14, modified Kindvall discloses the inorganic divalent cation is provided as a salt with chloride as an anion, ([pg 31 line 10-11] item 18 disclosing an embodiment where the salt may consist of CaCl2 a salt known to have a solubility that meets the limitation of claim 14).
Regarding claim 15, modified Kindvall discloses a nicotine source in the pouch, ([pg 3 line 15]), the nicotine source may be a nicotine base, ([pg 15 line 7]), and the composition comprises the nicotine source the range of about 1% to 10 % by weight, ([pg 32 lines 32-35], item 29), thus disclosing that composition comprises the nicotine base in an amount of at least 0.1wt%.
Regarding claim 31 and 34, modified Kindvall discloses the pouch composition comprises at least one water insoluble fiber selected from a group that includes maize fibers, oat fibers, rye fibers, and others that are claimed, ([pg 32 lines 22-27] embodiments including item 27).
Regarding claim 37, modified Kindvall discloses a pH regulating agent, ([pg 27 line 14-15] embodiment comprising item 1, [pg 28 lines 3-4] embodiment comprising item 2, [pg 28 lines 29-30] embodiment comprising item 3).
Claim(s) 59 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kindvall (WO 2020/157280 A1)(IDS 07/22/2021), and further in view of Bruun (US 2019/0255035 A1), Pederson et al. “Salivary Functions”, Oral Diseases pg 1399-1416, March 30, 2018, Walling (US 2003/0224048 A1), Anderson I (US 2014/0230833 A1), Anderson II (US 2013/0071338 A1), and as evidenced by Amberlite IRP64 Pharmaceutical Grade Ion Exchange Resin (Polacrilex Resin)(PTO-892 dated 01/17/2025).
Regarding claim 59, Kindvall discloses:
a pouch composition, ([pg 27 line 7 - pg 29 line 15], items 1, 2, or 3), comprising:
a mixture of nicotine free base and polacrilex resin, ([pg 33 line 1-3], item 30);
a nicotine source in the pouch, ([pg 3 line 15]), the nicotine source may be a nicotine base, ([pg 15 line 7]), the nicotine base may be bound to an ion exchange resin, such as polacrilex, ([pg 15 line 7-10], [pg 33 lines 1-3], item 30);
the nicotine source may be present in the range of about 1% to 10% by weight, ([pg 32 lines 32-35], item 29), thus disclosing that the composition may comprise nicotine free base in a range of 1% wt to 10% wt.
Thus, by disclosing that the nicotine source may be a nicotine base bound to an ion exchange resin such as polacrilex, Kindvall necessarily discloses the composition comprises nicotine free base in a weight% range of nicotine free base to a weight % range of the polacrilex resin, but leaves the selection of the relative weight% ranges to one of ordinary skill in the art;
water in an amount of at least 15% by weight of the pouch composition, ([pg 30 lines 17-19], item 12);
a water-insoluble fiber, ([pg 32 lines 22-27], item 27);
Kindvall discloses that the filling material may comprise a particulate non-tobacco material, ([pg 3 line 14]), explicitly disclosing that the non-tobacco particle material may be sugar alcohol, ([pg 14 line 26-29]), and water insoluble fiber, ([pg 15 line 1-2],[pg 32 lines 22-30] embodiments comprising item 27 and 28 include water insoluble fiber), ([pg 32 lines 13-19], embodiments comprising item 25 and 26 both disclosing the composition comprises a sugar alcohol. Kindvall discloses that the pouch comprises particulate non-tobacco material in a range from about 30 wt% to about 90 wt%, ([pg 14 lines 16-17]), and that the particulate non-tobacco material may comprise or consist of a sugar alcohol, further suggesting an exemplary sugar alcohol such as maltitol, ([pg 14 lines 26-27]). This disclosure reasonably suggests that a range of weight percentages of sugar alcohol can be used, including embodiments where the particulate non-tobacco material may consist of 30-90% by wt of sugar alcohol, and where the particulate non-tobacco material may comprise an unknown wt% of sugar alcohol, where the embodiment comprises 30 wt% to about 90 wt% total particulate non-tobacco material. This disclosure explicitly suggests using sugar alcohol comprising maltitol as a sweetener.
Kindvall discloses the composition may include a flavor, ([pg 33 lines 27-28], item 35);
an inorganic divalent cation selected from calcium and magnesium, ([pg 31 lines 10-11] item 18 disclosing an embodiment where the is provided in CaCl2);
wherein a molar ratio of the inorganic divalent cation relative to the nicotine free base in the mixture of nicotine free base and polacrilex resin is from 0.75 to 4.0, ([pg 33 lines 1-3] disclosing nicotine base bound to an ion exchange resin such as nicotine polacrilex, item 30), ([pg 32 lines 32-35] item 29 disclosing the nicotine source may be present in the composition from about 1 wt% to 10 wt% by weight of the nicotine source, ([pg 31 lines 10-12] the salt of formula I comprises CaCl2, item 18), ([pg 30 lines 21-23], item 13 the amount of salt present may be within a range of 0.05wt% to 5wt%), these ranges overlapping the claimed range because using the CaCl2 as the disclosed salt and nicotine freebase, in their average disclosed wt%, the molar ratio of cation to nicotine freebase is 1.49, which is within the claimed ratio and wt% range, rendering these ranges obvious;
a total content of the water-insoluble fiber, sugar alcohol and flavor is 50% by weight or more of the pouch composition, the particulate non-tobacco material may be within a range from about 30 wt% to about 90 wt%, ([pg 32 lines 7-9] item 24), and may comprise a sugar alcohol, ([pg 32 line 13-14]) and comprise water insoluble fibers, ([pg 32 line 29-30] item 28), reasonably suggesting to one or ordinary skill in the art to select amounts of sugar alcohol and water-insoluble fiber that combine to meet or exceed a compositions where the sugar alcohol and water insoluble fibers are 50% by weight or more of the pouch composition;
a nicotine source in the pouch, ([pg 3 line 15]), the nicotine source may be a nicotine base, ([pg 15 line 7]), the nicotine base may be bound to an ion exchange resin, such as polacrilex, ([pg 15 line 7-10], [pg 33 lines 1-3], item 30);
thus, by disclosing that the nicotine source may be a nicotine base bound to an ion exchange resin such as polacrilex, Kindvall necessarily discloses the composition comprises nicotine free base in a weight% range of nicotine free base to a weight % range of the polacrilex resin, but leaves the selection of the relative weight% ranges to one of ordinary skill in the art;
the composition comprises the nicotine source the range of about 1% to 10 % by weight, ([pg 32 lines 32-35], item 29), thus disclosing that composition comprises the nicotine base in a range from 1 wt% to 10 wt%.
Kindvall also does not disclose the wt% range of nicotine base compared to the wt% range of polacrilex resin.
Bruun teaches a pouch designed for the administration of an active ingredient in the oral cavity, ([0005]), and is therefore considered to be prior art within the Applicant’s field of endeavor. Bruun teaches that it is advantageous to include a release controlling composition within the oral pouch, ([0057]), and that by controlling the release of nicotine by means of controlling the supply of water in the form of salvia to the composition, a modified release may be obtained, ([0058]). Bruun teaches the matrix composition may be nicotine polacrilex resin ([0025]). Bruun teaches a number of embodiments using different carriers for the nicotine, with or without polacrilex resin, and in embodiments where sugar alcohol is not used as a carrier it may be used as a sweetener, (Bruun [0037]). Bruun teaches that sugar alcohol may be used as a sweetener in a range that is preferably between 20% to 98% of the weight of the pouch, ([0111]-[0112]).
Pederson teaches salivary functions related to taste, including that the presence of food results in an increased output of saliva, ([pg 1399 1. Introduction]), and is thus reasonably pertinent to the problem faced by the inventor because controlling the supply of water in the form of water in the form of saliva was a known method of controlling the release of nicotine taught by Bruun. Pederson teaches that the stimulation of salivary glands due to sweet tasting compositions was known, ([pg 1405 first full paragraph]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the amount of sugar alcohol in the form of maltitol as disclosed by Kindvall, or sorbitol as taught by Walling, to arrive at an amount of sugar alcohol in a range of 5% to 60% by weight, by adjusting the amount of sugar alcohol to arrive at a desired sweetness and provide an effective release rate of greater than 70% over a period of ten minutes, as taught by Walling, by providing a nicotine source in a range of 1-10%, as disclosed by Kindvall, and a corresponding cation exchange resin in a wt% amount of 4-40%, provided based on the ratio taught by Walling, and a wt% of sugar alcohol of 4%-40%, provided by the ratio taught by Walling, substantially overlapping the claimed range and rendering ranges within the 5% to 40% by wt of sugar alcohol in the form of maltitol, sorbitol, or equivalent sugar alcohols obvious to select to achieve a release rate of at least 70% in ten minutes.
Anderson I teaches nicotine delivery product comprising a cationic exchange resin, with a polyol, having a high nicotine release rate, ([0009]. [0011]) and is thus considered within the Applicant’s field of endeavor. Anderson I teaches a preferred cation exchange resin is polacrilex ion exchange resin, Amberlite IRP64, ([0029]). Anderson I teaches that the polyol may be several types including maltitol, ([0033]-[0036]). Anderson I teaches that the nicotine product has a high nicotine release rate of not less than 80% over a period of 10 minutes, ([0020]), and offers an explanation of why the release rate is so high, ([0022]). Anderson I teaches that in a product without polyol, the binding between nicotine and the cationic resin is dominated by ionic bonds, ([0023]), but that when the added polyol is present the polyol penetrates deeper into the resin particles before the loading of nicotine, such that the polyol will be concentrated in the center of the resin, and the nicotine will be concentrated on the surface, ([0024]-[0025] suggesting the nicotine is released more quickly because it is concentrated on the surface). Anderson I teaches a preferred water content of between 15-65 wt%, ([0039], and Anderson teaches that the weight ratio or the cationic ion exchange resin to nicotine is most preferably 4:1, ([0038] which provides a weight ratio of nicotine in an amount of 20% by weight to Amberlite IRP64 in an amount of 80% by weight, which meets the claimed limitation).
Anderson II teaches a method of producing a nicotine delivery product comprising a cation exchange resin, nicotine, and water, ([0011]), and thus is considered to be within the Applicant’s field of endeavor. Anderson II teaches a preferred amount of water is between 15-65 wt.%, more preferably 20-55 wt%, and most preferably between 25-45 wt%, and that preferably the water content is selected to avoid the use of a drying step to save energy, ([0024]-[0025]). Anderson II teaches that nicotine is an essential component of the mixture and that the preferred nicotine is in the form of nicotine base, ([0027]), with a concentration of nicotine in the mixture preferably between 5 and 50% by weight of the mixture, ([0028]). Anderson teaches that the weight ratio or the cationic ion exchange resin to nicotine is most preferably 4:1, ([0038] which provides a weight ratio of nicotine in an amount of 20% by weight to Amberlite IRP64 in an amount of 80% by weight, which meets the claimed limitation).
Amberlite evidences a polacrilex resin that is used commercially for the sustained release of nicotine, ([pg 1 heading identifier and first paragraph under description including bullet points]), and thus is considered prior art because it is within the Applicant’s field of endeavor. Amberlite evidences that the amount of drug loaded onto amberlite will be influenced by such factors as the affinity between the ion exchange resin and the drug, the concentration of the drug in the loading solution, the concentration and selectivity of competing cations, and the pH of the loading solution. ([pg 3, the section under Drug loading]). Amberlite evidences the rate and completeness of drug desorption will be controlled by the diffusion rate of the drug through the polymer phase of the resin, the selectivity of the drug for the resin, the concentration of electrolytes in the desorption environment, and that other resin-sorbate interactions are possible, indicating that these can have a pronounced effect on loading capacities and rates, ([pg 3 paragraphs under drug release]).
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 Kindvall according to the teachings of Anderson I & II. Kindvall discloses the wt% range of nicotine base, but not the wt% range of polacrilex, thus leaving the selection of the relative weight% ranges to one of ordinary skill in the art. Anderson I & II, both suggest the nicotine wt% to polacrilex resin should be preferably 20% nicotine to 80% polacrilex resin, with Anderson II teaching that the nicotine source should be nicotine base, and both Anderson I & II teaching that the water content should be in a range of 15-65 wt%; Anderson II teaching that the water content should be selected such that drying is not necessary, which is compatible with the 20-50 wt% range of water disclosed by Kindvall. Because Anderson I & II suggest compositions compatible with Kindvall, and further disclose a preferred relative wt% of nicotine to wt% of polacrilex resin, it is reasonably suggested to one of ordinary skill in the art to use 20 wt% of nicotine base to 80% wt of Amberlite IRP64 resin, and one of ordinary skill in the art would have a reasonable expectation of success in using these weight percents based on the release rates taught by Anderson I.
Modified Kindvall does not disclose the effective release of nicotine into water at 25 °C is 70% or higher after 20 minutes at a concentration of 28 mg/L and a stirring rate of 100 rpm. Amberlite evidences that the rate and completeness of drug desorption will be controlled by the diffusion rate of the drug through the polymer phase of the resin, the selectivity of the drug for the resin, the concentration of electrolytes in the desorption environment, and that other resin-sorbate interactions are possible, indicating that these can have a pronounced effect on loading capacities and rates, ([pg 3 paragraphs under drug release]). Modified Kindvall has a calcium cation that is present within the claimed molar ratio. Modified Kindvall has an amount of nicotine base and polacrilex resin in an amount that falls within the claimed relative amounts. Modified Kindvall has water in an amount of 20-50 wt%. Bruun teaches controlling available water by controlling the amount of saliva, and Pederson teaches that controlling sweetness will impact saliva production, reasonably suggesting controlling the amount of sugar alcohol present within the disclosed ranges to meet arrive at an effective release rate. Modified Kindvall discloses or renders obvious all of the compositional limitations that are expected to give rise to the claimed the functional limitations. MPEP 2173.05(g) Functional Limitations. “Unlike means-plus-function claim language that only applies to purely functional limitations, Phillips v. AWH Corp., 415 F.3d 1303, 1311, 75 USPQ2d 1321, 1324 (Fed. Cir. 2005) (en banc) ("Means-plus-function claiming applies only purely functional limitations to that do not provide the structure that performs the recited function."), functional claiming often involves the recitation of some structure followed by its function. One of ordinary skill in the art would understand a common use of the modified pouch composition would be as a nicotine replacement therapy, and that a release rate for an oral dose nicotine drug product should have a release rate of greater that 70% in 10 minutes for this obvious use. Thus, one of ordinary skill in the art would be motivated to check for compositions disclosed by the prior art and select compositions that meet this release rate for this purpose.
Here, many of the claimed limitations are understood in the context of the prior art references and the ordinary skill in the art as providing the claimed functional release rate. Because modified Kindvall renders the claimed compositional limitations obvious, those compositional limitations are understood to provide a composition that meets the functional limitations, because one of the uses for oral nicotine pouches is to provide nicotine therapy to smokers which is designed to ensure a quick release to alleviate an immediate craving for a cigarette as well as a sustained release to ensure that the blood nicotine levels are managed to avoid subsequent cravings, thus the functional limitations are considered to be met.
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.
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/D.E.V./Examiner, Art Unit 1747
/PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755