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 .
Claim Status
Claims 7 and 10-11 are previously withdrawn.
Claims 1-6 and 8 are rejected.
No claims are allowed.
Maintained Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-6, and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Duggins et al. (US 2017/0360767 A1, Dec. 21, 2017) (hereinafter Duggins).
Duggins teaches a multi-layered pharmaceutical composition comprising two or more formulations with varying properties (Abstract), specifically a nicotine-containing pharmaceutical composition intended to be administered to provide a pharmacological effect, or otherwise used for therapeutic purposes ([0001]). By “layered” it is meant that the structure of the multi-layered pharmaceutical composition is generally that of a core, surrounded by one or more coating layers, which may be partial or complete layers. In other words, each coating layer may completely coat the core or previous layer or may only cover portions thereof. The core can be any shape (e.g., square, round, oval, oblong, or rectangular) or a shape that can be described generally as spherical. The composition can be in the form of a lozenge. Side-by-side type configurations are also intended to be encompassed within the present invention, e.g., wherein the composition comprises two layers adhered together along one surface and, optionally, additional layers adhered to one or both of those two layers ([0023]). The shape of a representative composition can be generally spherical (i.e., round) ([0083]). The components of each formulation in the multi-layered pharmaceutical composition can vary and are independently selected such that the two or more formulations generally comprise different combinations of other components. The individual components (including, optionally, one or more nicotinic compounds) can be processed, blended, formulated, combined and/or mixed to produce the desired formulation ([0042]). The multi-layered pharmaceutical composition can comprise one or more nicotinic compounds, which may be the same or different ([0008]). Other components can include sugar alcohols or buffering agents, like sodium bicarbonate ([0043]). Exemplary sugar alcohols include erythritol, xylitol, and combinations thereof, in an amount of at least about 10 percent but will not exceed about 40 percent, based on the total dry weight of the composition ([0056]). The exterior formulation comprises a formulation that exhibits relatively fast release of nicotine, whereas the one or more internal formulations exhibit a more extended nicotine release profile, thus providing a product that provides both a fast initial release of nicotine and an extended release of nicotine ([0080]). When the composition is intended for use as a lozenge, the amount of nicotine within each dosage piece or unit is typically at least about 0.5 mg to about 10 mg, calculated as nicotine base. The amount of nicotine incorporated into any given formulation layer within a multi-layer composition can vary, and typically will be selected so as to provide an overall nicotine content within each product unit in the ranges noted above ([0065]). The nicotinic compounds can be in the form of a free base, a salt, a complex, or a solvate. The one or more nicotinic compounds can comprise, for example, nicotine polacrilex ([0009]). Salts can include nicotine bitartrate ([0038]). The buffering agents are typically present in an amount less than about 1 percent based on the dry weight of the formulation ([0061]). The composition is granulated and compressed ([0131]). The composition contains nicotine in amount effective to treat some symptoms of, or prevent occurrence of the symptoms of, the condition, disease, or disorder from which the subject or patient suffers ([0064]) and administration of nicotine has been employed in an effort to help cigarette smokers quit smoking (i.e., as a smoking cessation aid) ([0004]).
The prior art discloses a multi-layered (Abstract) lozenge ([0023]) containing a core surrounded by one or more coating layers, wherein each coating layer may only cover a portion of the core ([0023]), wherein each formulation of the multi-layered composition may vary and comprise different combinations of components, and wherein the components are one or more nicotinic compounds ([0042]), a buffering agent ([0043]), and a sugar alcohol([0043]) such as erythritol ([0056]). Together this would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding the limitation of claim 1 reciting “wherein the at least one buffer promotes a rapid uptake of nicotine through an oral mucosa”, because the composition of Duggins comprises sodium bicarbonate as the buffer and instant claims 2 and 3 limits the buffer that promotes a rapid uptake of nicotine through an oral mucosa of instant claim 1 to sodium bicarbonate, the composition of Duggins comprises a buffer that promotes a rapid uptake of nicotine through an oral mucosa.
Regarding the limitations of claim 1 reciting “so that the buffer(s) can rapidly and transiently increase the pH of the saliva in order to convert nicotine into its' free base form,” and “to enable a conversion of the nicotine salt to its free base form to promote a faster absorption of the nicotine and resulting in a lower fraction of nicotine being subject to transportation into the gastrointestinal tract,” as noted in the instant specification in paragraph [0011], if an acid drug salt like nicotine bitartrate is co-formulated in a product in such a way that the product also contains some readily available and fast released buffer(s), that are present in at least one film coating or at least one portion/layer on a lozenge, the buffer(s) can rapidly and transiently increase the pH of the solvent (in this case saliva) in order to convert nicotine into its' free base form resulting in a faster absorption of the nicotine released from at least one coating or portion/layer on the surface of a nicotine lozenge. Accordingly, because the lozenge of Duggins comprises nicotine bitartrate ([0038]), side-by-side type configurations of the layers (i.e., portions) adhered together along one surface ([0023]), and a buffer in at least one layer ([0043]), the lozenge of Duggins necessarily comprises available buffer(s) that can rapidly and transiently increase the pH of the saliva in order to convert nicotine into its free base form (i.e., the conversion of nicotine to its free base form will not be negatively affected) to promote a faster absorption of the nicotine in the oral mucosa, which results in a lower fraction of nicotine being subject to transportation into the gastrointestinal tract.
Regarding the limitation of claim 4 reciting “wherein the at least one buffer is present in an amount from about 1.0 to about 7.5 mg/lozenge," Duggins discloses wherein the buffering agent is in an amount of less than about 1 percent based on the dry weight of the formulation. Thus, assuming a 4 gram lozenge comprising 0.1% buffering agent, a lozenge comprising 0.004 grams (4 mg) of buffering agent would have been obvious. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding claim 5 reciting wherein the nicotine in the core is nicotine polacrilex and the nicotine salt in the second portion/layer is nicotine bitartrate, as discussed above, Duggins discloses a composition comprising a core and one or more layers, wherein each formulation of the composition may comprise different combinations of components, wherein the composition may comprise one or more nicotinic compounds, and wherein nicotinic compounds include nicotine polacrilex and nicotine bitartrate. Therefore, a core comprising nicotine polacrilex and a coating comprising nicotine bitartrate would have been obvious.
Regarding the limitation of claim 6 reciting “wherein the core comprises nicotine in an amount of from about 1.0 mg to about 7.5 mg and the second portion/layer comprises nicotine salt present in an amount of from about 0.25 mg to about 2.5 mg (calculated as the free base)”, as discussed above, Duggins teaches the amount of nicotine within each dosage piece or unit is typically at least 0.5 mg to 10 mg, calculated as nicotine base. As such, one of ordinary skill in the art would have been able to obtain an amount of from about 1.0 mg to about 7.5 mg in the core and an amount of from about 0.25 mg to about 2.5 mg in the one of the coatings (i.e., second portion/layer) from selecting from the range disclosed by Duggins. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Response to Applicant’s Arguments
Applicant argues that there is no appreciation of the inventive finding that erythritol in a first and second portion can facilitate manufacturability. Duggins does not disclose that erythritol could provide the characteristics necessary for fusing the portions onto the lozenge, or even a hint that erythritol is preferred over other sugar alcohols.
Applicant’s argument has been fully considered but found not to be persuasive. Applicant has not provided any objective evidence supporting Applicant’s assertion that erythritol in a first and second portion can facilitate manufacturability. Mere conclusory statements in the specification, unsupported by objective evidence, are entitled to little weight when the PTO questions the efficacy of those statements. In re Greenfield, 571 F.2d 1185, 197 U.S.P.Q. 227, 229 (C.C.P.A. 1978). Although paragraph [0084] of the instant specification discloses that use of xylitol as the primary polyol gave too long solidification times to be utilized in commercial manufacturing, isomalt had very fast solidification time but very high melting point (153° C.) which is not desirable from stability and safety perspective, and erythritol exhibited fast solidification and much lower melting temperature (121.5° C.), the instant specification does not provide objective evidence showing the comparison of the solidification times of xylitol, isomalt, and erythritol that lead to the conclusion that erythritol exhibited “fast” solidification when compared to xylitol and isomalt. Objective evidence is necessary to demonstrate that the results are both achievable and would not have been reasonably expected by a person of ordinary skill in the art. Further, the data provided by the Applicant in the instant specification does not show how the fast solidification and much lower melting temperature of erythritol directly results in portions containing erythritol fusing to lozenge. Objective data is necessary to demonstrate that the faster solidification and lower melting temperature are achievable and would not have been reasonably expected by a person of ordinary skill in the art. Additionally, Applicant has not provided any comparative examples. Comparison with the closest prior art is needed to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). Therefore, Applicant’s argument is unpersuasive.
For the foregoing reasons the rejection is modified and maintained.
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 Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614