DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of two layers, hydroxypropyl cellulose (HPC), and dextrose monohydrate in the reply filed on 06/25/2026 is acknowledged. Accordingly, claims 6-7, 23-24, and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim.
Status of Claims
The preliminary amendment of 08/20/2024 and remarks of 06/25/2026 are acknowledged. Claims 3, 6, 11, 16-17, 22-24, 33-34, 38, 41, 43-44, 47, 54, 68, 82, and 90 are amended and claims 4-5, 8-10, 12-15, 18-21, 25-32, 35-37, 39-40, 42, 45-46, 48-53, 55-67, 69-81, 83-89, and 91-111 are cancelled. Claims 6-7, 23-24, and 43 are withdrawn according to the election above. Claims 1-3, 11, 16-17, 22, 33-34, 38, 41, 44, 47, 54, 68, 82, and 90 are examined on the merits herein.
Priority
The instant application filed 08/20/2024, is a 371 filing of PCT/DK2022/050215, filed 10/12/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claim 11 defines a product by process limitation. In such a case it is not required that the prior art teach the same process, only that the final product meets all of the structural limitations of the instant claims. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP 2113.
Claims 16-17 and 33 also define a product by process wherein the one or more binders are added separately in the formulation. As discussed above, any final product which meets the structural limitations of the instant claims (i.e., comprises a binder in the final product) will read on comprising the instantly claimed binder, regardless of whether or not the binder was added separately.
Claim 54 recites the phrase “different grades of dextrose”, however, neither the claims nor the instant specification explicitly define what the term grade refers to. Given that the specification seems to allude to different grades being characterized by their chemical make-up and particle size, different grades of dextrose will be interpreted by its broadest reasonable interpretation as any two forms of dextrose with different physical, chemical, or structural properties.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-17, 33, 41, and 44 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 16-17 and 33 define one or more binders being separate from any binder being integrated in other ingredients in the tablet. Such a limitation is indefinite as it is not clear what is meant by “being separate from any binder being integrated in other ingredients in the tablet”. For the sake of compact prosecution the claim will be interpreted as a product-by-process limitation wherein the binder is added separately from other ingredients in the formulation. However, it is noted that the "determination of patentability [for product-by-process claims] is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As such, any composition having a binder in the final product will read on comprising the instantly claimed binder.
Claims 41 and 44 recite wherein “the dextrose comprises” X% “dextrose equivalents calculated on a dry basis”. Given the Examiners understanding of dextrose equivalents, dextrose equivalent (DE) describes the degree of conversion of starch to dextrose. Starch has a DE of 0% while dextrose has a DE of 100%. Thus, it is unclear how “dextrose” as defined in the instant claims can have a dextrose equivalence of anything less than 100%. By nature, “dextrose” must have a DE of 100%. For the sake of compact prosecution, claims 41 and 44, which define dextrose having a DE value other than 100%, will be interpreted as a dextrose-containing product having a DE within the instantly claimed range.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claims 1-3, 11, 16, 33-34, 38, 41, 47, 82, and 90 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Hugerth A. et al. (US 20100247586 A1, 09/30/2010, IDS dated 02/26/2024), hereinafter Hugerth, as evidenced by IMCD (2026). Dextrose Monohydrate M by Roquette (PTO-892), hereinafter IMCD, and Singh N, et al. (2023). Effects of Nicotine on the Central Nervous System and Sleep Quality in Relation to Other Stimulants: A Narrative Review. Cureus. 15(11):e49162 (PTO-892), hereinafter Singh.
Hugerth discloses multi portion intra-oral dosage form has at least one pharmaceutically active agent or health promoting agent with at least one portion comprises a component for creating a noticeable organoleptic sensation (abstract).
Regarding claim 1: Hugerth teaches a nicotine chewable tablet with a nicotine containing portion and a zinc containing portion (Ex. 11; [0158]). The nicotine containing portion comprises ~580 mg of dextrose and varying amounts of nicotine hydrogen tartrate (Table I1). The zinc containing portion comprises 353 mg of dextrose monohydrate and a 6.7 mg of zinc acetate dihydrate (Table I2). Overall, it appears that the total mg amount of the tablet is 1000 mg (600 mg nicotine core + 400 mg zinc containing portion). Thus, the total amount of dextrose in the chewable tablet is ~93% by weight of the tablet ([580 + 353] ÷ 1000), which falls within the instantly claimed range. The nicotine hydrogen tartrate in the nicotine portion reads on an active ingredient and is provided at amounts of 1.7, 3.4, 6.8, 10.2, and 13.6 mg, which in a 1000 mg tablet is equal to 0.17%, 0.34%, 0.68%, 1.02%, and 1.36% by weight of the tablet, respectively. The zinc acetate dihydrate in the zinc containing portion also reads on an active ingredient ([0108]) and is provided at an amount of 6.7 mg, which in a 1000 mg tablet is equal to 0.67% by weight of the tablet. All of these amounts, individually or together, fall within the instantly claimed range of the active ingredient (i.e., 0.1 to 50%). The double portion tablet is compressed according to a similar method as Example 1 ([0160]), which teaches compressing two portions of separately blended ingredients to provide a dual portion lozenge ([0128]). As such, the final tablet comprises at least two compressed layers containing said dextrose and the active ingredients, with the first layer being cohered to and adjacent to the second layer, as instantly recited.
Regarding claim 2: As discussed above, the double portion tablet is compressed according to a similar method as Example 1 ([0160]), which teaches compressing two portions of separately blended ingredients to provide a dual portion lozenge ([0128]). Such a tablet thereby consists of two layers.
Regarding claim 3: It appears the nicotine portion makes up 600 mg of the total tablet ([0158; Table I1) while the zinc containing portion makes up 400 mg of the total tablet (Table I2). The ratio is therefore 1.5:1 or 1:1.5, either of which fall within the instantly claimed range (i.e., 1:10 to 10:1).
Regarding claim 11: The dual portion tablet of Example 11 is compressed according to a similar method as Example 1 ([0160]), which teaches blending the portions separately and compressing the two portions into tablets by means of direct compression. The powder compression may for example be performed using a double-sided rotary tablet press with individual filling stations and where each of the two portions are subjected to pre-compression and main compression, respectively, to form a dual portion lozenge ([0128]). Such a method reads on pre-compressing the first layer by direct compression in a tableting machine and compressing the second layer on top of the first layer. Regardless of the production method, the dual portion tablet of Hugerth reads on every structural limitation as instantly claimed, and therefore reads on the tablet generated by the method of claim 11.
Regarding claim 16: Polyvinyl pyrrolidone (PVP) is present in the nicotine portion of the tablet (Table I1), which is defined by Hugerth as a conventional dry binder ([0094]). Additionally, polyethylene glycol (PEG) is present in the nicotine portion of the tablet (Table I1), which is defined by Hugerth as an edible adhesive-like material (i.e., binder) ([0111]).
Regarding claim 33: Talking the 1 mg dosage unit of Example 11 as an example, the tablet comprises 935 mg of dextrose (i.e., 582 + 353), 3.4 mg of nicotine hydrogen tartrate (i.e., active), and 6.7 mg of zinc acetate dihydrate (i.e., active)(Table I1-I2). The PVP and PEG binders/adhesives make up 10 mg of the total tablet (i.e., 4 + 6) (Table I1). Together, these ingredients which read on the dextrose, active ingredients, and binders, make up 955.1 mg of the total 1000 mg tablet, which reads on 95.51% of the tablet. As such, the remaining ingredients which may be characterized as “auxiliary ingredients” make up 4.49% of the final tablet.
Regarding claim 34: Talking the 1 mg dosage unit of Example 11 as an example, the tablet comprises 935 mg of dextrose (i.e., 582 + 353), 3.4 mg of nicotine hydrogen tartrate (i.e., active), and 6.7 mg of zinc acetate dihydrate (i.e., active)(Table I1-I2). Together, these ingredients which read on the dextrose and one or more active ingredients, make up 945.1 mg of the total 1000 mg tablet, which reads on 94.5% by weight of the tablet. As such, the remaining ingredients which may be characterized as “auxiliary ingredients” make up 5.49% by weight of the final tablet, which reads on auxiliary ingredients present up to about 5% by weight of the tablet. The term “about” is defined in the instant specification as numbers that fall within a range of 20% in either direction of the number. As such, the “about 5%” recited in claim 33 encompasses values of 4 to 6%.
Regarding claim 38: The dextrose in the zinc containing portion is defined as dextrose monohydrate (Table I2). While the “dextrose” in the nicotine portion is not explicitly defined, Hugerth teaches that the compressible excipient is in the form of a hydrate, and may be selected from organic compounds such as dextrose monohydrate ([0084]).
Regarding claims 41 and 47: Dextrose monohydrate comprises 99-100% dextrose equivalents as evidenced by IMCD.
Regarding claim 82: It has been demonstrated without a reasonable doubt that people who partake in nicotine do, in fact, experience an increase in their levels of alertness, wakefulness, attention, and focus, as evidenced by Singh (abstract). Therefore, nicotine reads on an energy stimulating active ingredient as claimed.
Regarding claim 90: The tablet of Example 11 comprises crospovidone (Table I2), which reads on the instantly claimed disintegrant.
Claims 1-3, 11, 16, 38, 41, 47, and 68 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Luber J. et al. (US 20110318411 A1, 12/29/2011, PTO-892), hereinafter Luber, as evidenced by IMCD (2026). Dextrose Monohydrate M by Roquette (PTO-892), hereinafter IMCD.
Luber discloses a tablet containing a first layer and a second layer (abstract).
Regarding claim 1: Luber specifically teaches a bi-layered orally disintegrating tablet having loratadine in one layer and diphenhydramine in the other layer. 265.58 mg of the powder blend containing loratadine from Table 1 is placed into the forming cavity and tamped. 360.073 mg of the powder blend containing diphenhydramine (DPH) from Table 2 is then added into the forming cavity and tamped to create a 625.65 mg tablet (Example 11). The loratadine formulation comprises 120 mg of dextrose monohydrate (Table 1) and the DPH formulation comprises 219 mg of dextrose monohydrate (Table 2). Together dextrose monohydrate comprises 54.2% by weight of the total tablet ([120 + 219] ÷ 625.65), which falls within the instantly claimed range (i.e., 50-95%). Loratadine, which reads on an active ingredient, is present at 10 mg in the final tablet which equates to 1.6% by weight of the total tablet (i.e., 10 ÷ 625.65). DPH, also reading on an active ingredient, is present at 35.7 mg in the final tablet which equates to 5.7% by weight of the total tablet (i.e., 35.7 ÷ 625.65). Both of these amount, independently and together, read on the instantly claimed amount of the one or more active ingredients (i.e., 0.1 to 50%). As discussed above, the first layer is placed in a cavity and tamped (i.e., compressed) and then the second layer is added on top and tamped, thereby reading on a tablet having at least two compresses layers containing dextrose and the one or more actives, the first of the compressed layers being cohered to and adjacent to the second layer. Regarding the recitation of “chewable”, if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See MPEP 2111.02. In the instant case “chewable” is an intended use limitation that does not further structurally limit the claimed tablet.
Regarding claim 2: The tablet of Example 11 is bi-layered, meaning it comprises two layers.
Regarding claim 3: The loratadine layer makes up 265.58 mg of the final tablet while the DPH layer makes up 360.073 mg. As such, the ratio is 1:1.35 or 1.35:1, either of which fall within the instantly claimed range (i.e., 1:10 to 10:1).
Regarding claim 11: As discussed above, the tablet is made by first tamping down the first layer in a cavity, which reads on being pre-compressed by direct compression, and then tamping down the second layer on top, which reads on being compressed on top of the first layer. While a tableting machine is not explicitly defined, the claim is considered a product-by process. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." See MPEP 2113. In the instant case, the tablet of Luber meets every structural limitation as instantly claimed meaning it is the same as a tablet that would result from the process as claimed.
Regarding claim 16: The tablet comprises a binder in the form of polyethylene glycol (claim 11; Table 1; Table 2). Additionally, the powder blends contain at least one carbohydrate which can act as the binder upon heating, maltodextrin is used in Example 11 ([0055]; Table 1; Table 2).
Regarding claim 38: The dextrose is dextrose monohydrate (Table 1; Table 2).
Regarding claims 41 and 47: Dextrose monohydrate comprises 99-100% dextrose equivalents as evidenced by IMCD.
Regarding claim 68: Loratadine, which reads on an active ingredient, is present at 10 mg in the final tablet which equates to 1.6% by weight of the total tablet (i.e., 10 ÷ 625.65). DPH, also reading on an active ingredient, is present at 35.7 mg in the final tablet which equates to 5.7% by weight of the total tablet (i.e., 35.7 ÷ 625.65). Together, the one or more actives are present 7.3% by weight of the tablet, which falls within the instantly claimed range (i.e., 5 to 50%).
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.
1. Claims 1-3, 11, 16-17, 33-34, 38, 41, 47, 68, 82, and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Hugerth A. et al. (US 20100247586 A1, 09/30/2010, IDS dated 02/26/2024), hereinafter Hugerth, as evidenced by IMCD (2026). Dextrose Monohydrate M by Roquette (PTO-892), hereinafter IMCD, and Singh N, et al. (2023). Effects of Nicotine on the Central Nervous System and Sleep Quality in Relation to Other Stimulants: A Narrative Review. Cureus. 15(11):e49162 (PTO-892), hereinafter Singh.
The teachings of Hugerth, as supported by IMCD and Singh, are discussed above, as are the rejections of claims 1-3, 11, 16, 33-34, 38, 41, 47, 82, and 90.
As discussed above, Hugerth teaches Polyvinyl pyrrolidone (PVP) in the nicotine portion of the tablet (Table I1) as a conventional dry binder ([0094]). Additionally, polyethylene glycol (PEG) is present in the nicotine portion of the tablet (Table I1) as an edible adhesive-like material (i.e., binder) ([0111]). PVP is present at an amount of 4 mg in the final tablet and PEG is present at an amount of 6 mg in the final tablet (Table I1). Together in a 1000 mg tablet, they make up 1% of the total weight.
Also discussed above, the active nicotine hydrogen tartrate is provided at amounts of 1.7, 3.4, 6.8, 10.2, and 13.6 mg, which in a 1000 mg tablet is equal to 0.17%, 0.34%, 0.68%, 1.02%, and 1.36% by weight of the tablet, respectively. The zinc acetate dihydrate active is provided at an amount of 6.7 mg, which in a 1000 mg tablet is equal to 0.67% by weight of the tablet.
The teachings of Hugerth differ from that of the instantly claimed invention in that Hugerth does not explicitly teach the amount of the one or more binders, as recited in claim 17, nor the amount of the one or more active ingredients, as recited in claim 68.
While the amount of the one or more binders taught by Hugerth does not fall within the instantly claimed range of claim 17 (i.e., 2-15%), it is well within the abilities of an ordinary artisan to optimize the total amount of binder in the tablet depending on the desired structure and release profile of the final product. As such, it would have been prima facie obvious to one of one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to optimize the total amount of binder in the final product using the amounts taught by Hugerth as a starting point. One of ordinary skill in the art would have arrived at the instantly claimed range of 2 to 15% by weight through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
While the amounts of the one or more active ingredients taught by Hugerth do not fall within the instantly claimed range of claim 68 (i.e., 5 to 50%), it is well within the abilities of an ordinary artisan to optimize the total amount of active in the tablet depending on the desired dosage and therapeutic effect of the final product. As such, it would have been prima facie obvious to one of one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to optimize the total amount of actives in the final product using the amounts taught by Hugerth as a starting point. One of ordinary skill in the art would have arrived at the instantly claimed range of 5 to 50% by weight through no more than routine experimentation. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
2. Claims 1-3, 11, 16, 22, 33-34, 38, 41, 44, 47, 52, 54, 82, and 90 are rejected under 35 U.S.C. 103 as being unpatentable over Hugerth A. et al. (US 20100247586 A1, 09/30/2010, IDS dated 02/26/2024), hereinafter Hugerth, in view of Brys K. et al. (WO 2009015880 A1, 12/29/2011, IDS dated 02/26/2024), hereinafter Brys, as evidenced by IMCD (2026). Dextrose Monohydrate M by Roquette (PTO-892), hereinafter IMCD, and Singh N, et al. (2023). Effects of Nicotine on the Central Nervous System and Sleep Quality in Relation to Other Stimulants: A Narrative Review. Cureus. 15(11):e49162 (PTO-892), hereinafter Singh.
The teachings of Hugerth, as supported by IMCD and Singh, are discussed above, as are the rejections of claims 1-3, 11, 16, 33-34, 38, 41, 47, 82, and 90.
Hugerth further teaches wherein the tablet may comprises water-swellable excipients such as hydroxypropyl cellulose ([0087]). Additionally, the nicotine chewable tablet of Example 11 has a rapidly dissolving portion (i.e., the zinc layer). The zinc containing rapidly dissolving portion is discernable by mouth feel (removed from other portion by sucking on the dosage form). The onset of the nicotine is also discernable to the subject by mouth feel (the nicotine containing portion is intended to be chewed) ([0158]).
The teachings of Hugerth differ from that of the instantly claimed invention in that Hugerth does not explicitly teach wherein the one or more binders comprises hydroxypropyl cellulose, as recited in claim 22, nor wherein the dextrose comprises 93 to 97% dextrose equivalents, as recited in claim 44, and the tablet comprises different grades of dextrose in different layers, as recited in claim 54.
Brys discloses a direct compressible dextrose composition and processes for preparing pharmaceutical formulations or food formulations in tablet form using the direct compressible dextrose (abstract). It is generally accepted that the preparation of a dextrose in powder form having sufficient compressibility properties and suitable to prepare tablets with desirable properties, requires the mixing of α dextrose monohydrate with additives, such as maltose, maltodextrins or other polysaccharides with a higher degree of polymerisation (DP) (p. 3, para. 4). A prior US patent teaches dextrose monohydrate can be used as a direct compaction vehicle in compressed chewable antacid tablets. The dextrose monohydrate form may be one of several commercially available direct compressible dextrose preparations. These dextrose preparations, however, are known to contain 5% to 6% of maltose, maltotriose and maltodextrins with a higher DP, and are generally obtained by atomisation of a glucose syrup with a dextrose equivalent (DE) in the range of 93% to 99% (p. 4, para. 3). A dextrose product having a DE of 93% reads on the dextrose of claim 44, as best interpreted given the 112(b) issue above.
Brys specifically teaches a direct compressible dextrose composition obtainable by a dry granulation process which results in a direct compressible dextrose composition in the form of granules with a given particle size distribution (p. 5, para. 3). The direct compressible dextrose allows for tablets with higher tablet hardness compared to conventionally used dextrose. This in turn enables the incorporation of more active ingredient(s) while maintaining a certain tablet hardness. Furthermore, the direct compressible dextrose composition allows to prepare tablets having a certain hardness using a lower compression force. Finally, the friability of tablets produced using the direct compressible dextrose composition of the invention is lower and, thus, more resistant against shipment and abrasion on handling (p. 5-6, bridging paragraph). The tablet hardness and friability are highly important properties of a chewable tablet comprising active ingredient(s) and having desirable chewability properties. The direct compressible dextrose is particularly suited to meet these needs (p. 12, para. 1). Brys teaches C*PharmaDex 02011 dextrose monohydrate for forming roller compaction (RC) granules and compares its performance to non-roller compacted C*PharmaDex 02011 (i.e., powder) (Example, 1.1 Materials). The compression profile, i.e. the tensile strength as a function of compression force, of tablets made of RC dextrose was found to be much higher than the compression profile of tablets made of non RC dextrose. The RC dextrose tablets show good friability values at compression forces of around 15 kN or higher, with a value below the 1% limit. In contrast, the tablets made of non RC dextrose did not go below the 1% limit (p. 20-21, Hardness and Friability). Given the broadest reasonable interpretation above, the RC and non RC dextrose read on different grades of dextrose as recited in claim 54.
The direct compressible dextrose composition is additionally blended with one or more excipients well-known in the art, such as binders to further increase the cohesive properties of the direct compressible dextrose composition. Typical binders include hydroxypropyl cellulose (HPC) and polyvinylpyrrolidone (p. 10, para. 4). Hydroxypropyl cellulose reads on the binder of claim 22.
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate hydroxypropyl cellulose (HPC) into the tablet of Hugerth since HPC is a known and routine binder in the art as taught by Brys. One of ordinary skill in the art could have replaced the PVP binder of Hugerth with the hydroxypropyl cellulose binder of Brys via simple substitution of one known binder for another to predictably yield the instant invention. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Brys teaches both PVP and HPC as suitable binders for use in compressible dextrose tablet, and the tablet of Hugerth is prepared via compression. Furthermore, Hugerth welcomes the addition of excipients such as HPC
Second, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use a dextrose product with a dextrose equivalent (DE) of 93% since such forms of dextrose monohydrate are known and routine in the art as taught by Brys. One of ordinary skill in the art could have replaced the dextrose monohydrate of Hugerth with a dextrose preparations having a DE of 93% via no more than simple substitution of one known element for another to yield predictable results. One of ordinary skill in the art would have had a reasonable expectation of success since both Hugerth and Brys teach dextrose monohydrate in compressible chewable tablets.
Lastly, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use different grades of dextrose in different layers of the Hugerth tablet, since Hugerth teaches that the different layers are discernable by mouth feel and Brys teaches that different “grades” of dextrose provide different hardness and friability properties. Both the nicotine and zinc layer of Hugerth contain dextrose, however, the zinc layer is meant to be fast dissolving and the nicotine layer is meant to be chewable as taught by Hugerth. Brys teaches a direct compressible granulated dextrose (RC dextrose), which improves hardness and friability following compression as compared to non RC dextrose. Brys also teaches that the hardness and friability achieved with the RC dextrose is ideal for chewable tablets. Given these teachings, one of ordinary skill in the art would have found it obvious to use the RC dextrose of Brys in the chewable nicotine portion of the tablet and the non RC dextrose in the fast dissolving zinc portion of the tablet, as motivated by the difference in hardness and friability achieved by the different “grades” of dextrose. One of ordinary skill in the art would have had a reasonable expectation of success in making such a modification since Hugerth and Brys teach compressible dextrose formulations for chewable tablets comprising actives.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNAH S ARMSTRONG whose telephone number is (571)272-0112. The examiner can normally be reached Mon-Fri 7:30-5 (Flex).
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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