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 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.
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) Claim(s) 1-13, 15-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Serpelloni et al., (US 5,629,042, cited in IDS) in view of Chao et al., (WO 03/020736, cited in IDS).
Serpelloni et al. teaches, “A sugar-free boiled sweet containing at least one water-crystallizable polyol and having a water-content and a glass transition temperature, measured for a specific water content, at least equal to 38ºC.” (Abstract).
Serpelloni et al. further teaches that the glass transition temperature may exceed 38°C insofar as it teaches, "The applicant company has observed that an ever greater stability is obtained by making sure that the glass transition temperature, measured for water content of about 3.2%, and preferably for the effective water content of the boiled sweet, is at least equal to 40° C., the ideal situation being to exceed 43ºC. and even better to exceed 45°C" (col. 5, lines 24-29). Accordingly, it would have been obvious for the glass transition temperature to range from 50°C to 100°C, as per claims 2-3.
“Boiled sweets, also commonly called hard sweets or hard boiled candies, are solid and essentially amorphous confectionery products” (col. 1, lines 11-14), as per claim 4.
The boiled sweet is taught therein to have “a water content greater than 3%, a content in at least one crystallizable polyol comprised between 5% and 100%, preferably between 10 and 90%, and still more preferably between 15 and 77%, this content being expressed on a dry matter basis, and a glass transition temperature at least equal to 38º C.” (col. 4, lines 1-6).
Further, “The complement to 100% of the dry matter of the sugar-free hard candy in accordance with the invention can be constituted of oligo-saccharides and polysaccharides which are reputed to be scarcely digestible, that is to say less digestible than sugars. They may be in particular oligosaccharides and polysaccharides, dextrins, or polyglugoses such as polydextroses” (soluble fibers) (col. 4, lines 61-67).
The soluble fibers can be in amounts greater than or equal to 40% of the lozenge insofar as the prior art teaches, "The particular carbohydrate composition suitable to be used in accordance with the invention can be a syrup containing from 5 to 45%, preferably 10 to 40% and more preferably from 15 to 35% of mannitol or erythritol. The complement to 100% of the dry matter may consist of digestible oligo-saccharides and polysaccharides such as those previously defined" (col. 5, lines 5-13). Accordingly, it is within the scope of the prior art for the compositions to comprise up to 95% oligosaccharide, as per claims 10-11.
The prior art teaches a specific embodiment of a boiled sweet comprising "85% of polydextrose marketed by PFIZER under the trademark LITESSE® II and 15% of mannitol marked by the applicant", wherein "a flavoring agent and a sweetening mixture of aspartame and of acesulfame K are added" (additives)( (col. 6, Example 2, lines 45-59). "The sweets so obtained, which are in accordance with the invention, have a water content of 3.10% and a glass transition temperature close to 45° C" (Id. at lines 60-62). This embodiment is free of cellulosic fibers, as per claim 15.
Concerning claims 16-19, Serpelloni et al. teaches, “added various substances such as flavourings, colourings, intense sweeteners, acids, plant extracts, vitamins and pharmaceutical active ingredients” (col. 1, lines 40-44)
It is noted that the prior art does not require a non-cross-linked soluble fiber; however, since cross-linked fibers are also not required in the prior art formulations, it would have been obvious to include non-crosslinked fibers to the exclusion of cross-linked fibers.
The prior art teaches a lozenge comprising soluble fiber (i.e. oligosaccharides) in an amount of greater than 40% having a glass transition temperature greater than 37ºC. However, it does not teach wherein plasticizers are dispersed within the soluble fibers.
Chao et al. teaches compositions comprising clindamycin (Abstract), wherein the compositions for oral administration "can be in the form, for example, of a tablet, a caplet, a pill, a hard or soft capsule, a lozenge, a cachet (p. 13, lines 25-29).
The compositions "optionally comprise one or more pharmaceutically acceptable plasticizers. Suitable plasticizers include fractioned coconut oil (medium-chain triglycerides)" (p. 13, para. [0050]) (claim 5). Excipients, including plasticizers, are taught to be "solids, semidolids" and may be "prepared by any known technique of pharmacy that comprises admixing an excipient with a drug or therapeutic agent" (p. 13, para. [0047]).
In regard to claims 6-7, Chao et al. does not provide a range for the plasticizers; however, "[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" (see MPEP 2144.05 IIA quoting In re Aller, 220 F.2d 454, 456 (105 USPQ 233)). Accordingly, the artisan would have been reasonably expected to add enough plasticizer to the lozenge to achieve the desired softness. This type of modificationwould have been well within the purview of the skilled artisan and no more than an effort to optimize results.
It would have been obvious to a person having ordinary skill in the art at the time
of applicants filing to disperse a triglyceride within the soluble fibers of the lozenge of
Serpelloni et al. since triglycerides serve as plasticizers for lozenges, as taught by Chao
et al. The artisan would have been motivated by the desire to make the lozenge pliable, preventing it from cracking, breaking, or crumbling during storage, or while it is being sucked.
2) Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being
unpatentable over Serpelloni et al., (US 5,629,042, cited in IDS) and Chao et al., (WO 03/020736, cited in IDS) as applied to claims 1-13, 15-19 above, and further in view of Muhammad et al., (US 5,167,964, cited in IDS).
Serpelloni et al., which is taught above, differs from claims 19, insofar as it
does not teach a coating.
Muhammad et al. teaches "semi-enteric drug delivery systems" (Abstract), which
may be in the form of a "lozenge", which "are generally in two forms: hard, boiled
candy lozenges and compressed tablet lozenges" (col. 8, lines 53-58).
As part of the delivery system, plasticizing agents are added in a coating layer
"to facilitate processing by increasing the flexibility and toughness of the final product by
internally modifying (solvating) the polymer molecule" (col. 6, lines 51-57), wherein
suitable plasticizing agents include "mono-, di- and triglycerides, and the like" (col. 7,
line 1). The triglyceride may be present "in an amount up to about 3%, and preferably
about 0.7%, by weight" (Id. at lines 5-8).
It would have been obvious to a person having ordinary skill in the art at the time of applicants filing to add a coating to the compositions of Serpelloni et al., as per claim 20, for the advantage of increasing the flexibility and toughness of the final product, as taught by Muhammad et al.
3) Claim(s) 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Antreg auf Nichtnennung (DE 19811167, published 1999, cited in IDS) in view of Normand et al., (US 2005/0152932, cited in IDS) and further in view of Peters et al., (US 4,647,459, cited in IDS).
Antreg teaches a lozenge comprising greater than 90% maltodextrin (a matrix including a soluble fiber), up to 5% magnesium citrate, up to 3% orange peel powder, up to 0.04% vitamins B1, B2, additives, adjuvants up to 6% (see column 1, bottom), a per claims 10-13, 16-18.
Maltodextrin is amorphous (i.e. non-crystalline) and non-crosslinked. The lozengeis free of cellulosic fibers, sugars and polyols, as per claims 14-15.
Antreg does not teach a plasticizer or a glass transition temperature.
Normand et al. teaches a flavor delivery system including lozenges [p. 3, para. [0027]) and maltodextrin (p. 2, para. [0019]).
Normand et al. teaches, "The concept of glass transition temperature (Tg) is well described in the prior art. Implicit in much of the literature is the converse, namely that at temperatures above Tg, the encapsulation of flavor or perfume molecules will be ineffective, hence the importance of creating polymeric encapsulating materials with Tg values above ambient temperature" (p. 1, para. [0005]).
Accordingly, it would have been obvious to have a glass transition temperature ranging from about 50°C and 120°C, above ambient temperatures (e.g. about 20°C to 25°C) in order to provide a storage stable lozenge.
The lozenges of Normand et al. further comprise “plasticizers”, which is recited therein as “an essential component”, where suitable plasticizers include “propylene glycol, glucose, isomalt, corn starch syrup, glycerol, ethylene glycol, isomalt, corn starch syrup, glycerol, ethylene glycol, dipropylene glycol, butylene glycol, triacetin . . . “ (p. 4, para. [0035]), as per claims 5.
“The proportion of plasticizer in the delivery system varies between 5 and 95% by weight of the total weight of the composition” (Id. para. [0036]), as per claims 6-7.
The combination of Antreg and Normand et al, which is taught above, does not teach water for the lozenges.
Peters et al. teaches confectionary compositions including lozenges (Abstract). According to Peters, lozenges may comprise "from 0.1% to 5.0% water" (col. 4, lines 53-59).
This teaching in Peters is apropos insofar as Antreg teaches administering the maltodextrin in the form of a lozenge.
Generally, it is prima facie obvious to select a known material based on its suitability for its intended use (see MPEP 2144.07). Also, established precedent holds that it is generally obvious to add known ingredients to known compositions with the expectation of obtaining their known function (see 2144.06).
It would have been obvious to a person having ordinary skill in the art at the time of applicant’s filing to add a glass transition, plasticizers, and water to the lozenges of Antreg based on their suitability for their intended use in lozenge formulations, as taught by Normand et al. and Peters et al.
4) Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Antreg auf Nichtnennung (DE 19811167, published 1999, cited in IDS) in view of Normand et al., (US 2005/0152932, cited in IDS) and further in view of Peters et al., (US 4,647,459, cited in IDS) as applied to claims 1-19 above, and further in view of Muhammad et al., (US 5,167,964, cited in IDS).
The combination of Antreg, Normand et al., and Peters et al., which is taught above, differs from claims 19, insofar as it does not teach a coating.
Muhammad et al. teaches "semi-enteric drug delivery systems" (Abstract), which
may be in the form of a "lozenge", which "are generally in two forms: hard, boiled
candy lozenges and compressed tablet lozenges" (col. 8, lines 53-58).
As part of the delivery system, plasticizing agents are added in a coating layer
"to facilitate processing by increasing the flexibility and toughness of the final product by
internally modifying (solvating) the polymer molecule" (col. 6, lines 51-57), wherein
suitable plasticizing agents include "mono-, di- and triglycerides, and the like" (col. 7,
line 1). The triglyceride may be present "in an amount up to about 3%, and preferably
about 0.7%, by weight" (Id. at lines 5-8).
It would have been obvious to a person having ordinary skill in the art at the time of applicants filing to add a coating to the compositions of Antreg, as per claim 20, for the advantage of increasing the flexibility and toughness of the final product, as taught by Muhammad et al.
Nonstatutory Obvious-type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
1) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,943,511. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising a body that is wholly receivable in an oral cavity, comprising a matrix including a soluble fiber and a glass transition temperature greater than 37°C. The '511 patent anticipates the instant claims insofar as it claims a "digestion-resistant maltodextrin matrix" and nicotine as the additive dispersed in the matrix. The '511 patent also claims wherein the composition is substantially free sugars and sugar alcohols, as per claims 25-26, and non-porous (see claim 19), therapeutic agents (see claim 8), plasticizer (see claim 25), water (claim 18).
2) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 9,351,936. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising a body that is wholly receivable in an oral cavity, comprising a matrix including a soluble fiber and a glass transition temperature greater than 37°C. The '936 patent anticipates the instant claims insofar as it claims a specific matrix, i.e. "digestion-resistant maltodextrin matrix" and nicotineas the additive dispersed in the matrix. The '936 patent also claims wherein the composition is substantially free sugars and sugar alcohols, as per claims 25-26, and non-porous (see claim 20), therapeutic agents (see claim 9), plasticizer (see claim 26), water (claim 19).
3) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,244,786. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising a body that is wholly receivable in an oral cavity, comprising a matrix including a soluble fiber and a glass transition temperature greater than 37°C. The '786 patent anticipates the instant claims insofar as it claims a specific matrix, i.e. "an amorphous soluble-fiber matrix" and tobacco as the additive dispersed in the matrix. The '786 patent does not require sugars or sugar alcohols, thus it would have been obvious to exclude them, as per claims 25-26, and non-porous (see claim 9), therapeutic agents (see claim 4), plasticizer (see claim 19), water (claim 7).
4) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 9,999,243. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising a body that is wholly receivable in an oral cavity, comprising a matrix including a soluble fiber and a glass transition temperature greater than 37°C. The '243 patent anticipates the instant claims insofar as it claims a specific matrix, i.e. "maltodextrin" and exhausted tobacco fiber as the additive dispersed in the matrix. The '243 patent also claims wherein the composition is substantially free sugars and sugar alcohols, as per claims 25-26, and non-porous (see claim 17), therapeutic agents (see claim 8), plasticizer (see claim 23), water (claim 16).
5) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10,105,320. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising a body that is wholly receivable in an oral cavity, comprising a matrix including a soluble fiber and a glass transition greater than 37°C. The '320 patent anticipates the instant claims insofar as it claims a specific matrix, i.e. "maltodextrin matrix" and a generic additive dispersed in the matrix and water. The '320 patent also claims wherein the composition is substantially free sugars and sugar alcohols, as per claims 25-26, and non-porous (see claim 12), therapeutic agents (see claim 5), plasticizer (see claim 18).
6) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 10,702,516 in view of Muhammad et al., (US 5,167,964, cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a lozenge comprising a body that is wholly receivable in an oral cavity, comprising a matrix including a soluble fiber and a glass transition temperature greater than 37°C. The '516 patent anticipates the instant claims insofar as it also claims a generic soluble-fiber matrix, but nicotine as the additive dispersed in the matrix. The '516 patent claims exclusion of sugars or sugar alcohols (see claim 8), as per claims 25-26, a non-porous property (see claim 11), water (claim 10) and therapeutic agents, generally (see claim 3).
The '516 patent differs from the instant claims insofar as it does not claim triglycerides.
Muhammad et al. teaches "semi-enteric drug delivery systems" (Abstact), which may be in the form of a "lozenge", which "are generally in two forms: hard, boiled candy lozenges and compressed tablet lozenges" (col. 8, lines 53-58).
As part of the delivery system, plasticizing agents are added "to facilitate processing by increasing the flexibility and toughness of the final product by internally modifying (solvating) the polymer molecule" (col. 6, lines 51-57), wherein suitable plasticizing agents include "mono-, di- and triglycerides, and the like" (col. 7, line 1). The triglyceride may be present "in an amount up to about 3%, and preferably about 0.7%, by weight" (Id. at lines 5-8), as per claim 6.
It would have been obvious to include a plasticizer based on its art-recognized suitability for use in lozenges, as taught by Muhammad et al.
7) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,554,099. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising soluble fiber having a glass transition temperature greater than 37°C, including additives, e.g. triglycerides, and water.
8) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10,925,309 in view of Muhammad et al., (US 5,167,964, cited in IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a lozenge comprising a body that is wholly receivable in an oral cavity, comprising a matrix including a soluble fiber and a glass transition temperature greater than 37°C. The '309 patent anticipates the instant claims insofar as it also claims a generic soluble-fiber matrix, but nicotine as the additive dispersed in the matrix. The '309 patent claims exclusion of sugars or sugar alcohols, as per claims 25-26, a non-porous property, and therapeutic agents.
The '309 patent differs from the instant claims insofar as it does not claim triglycerides or water.
Muhammad et al. teaches "semi-enteric drug delivery systems" (Abstact), which may be in the form of a "lozenge", which "are generally in two forms: hard, boiled candy lozenges and compressed tablet lozenges" (col. 8, lines 53-58). Thes lozenges also comprise “from about 0.1% to about 5% water, by weight of the final composition” (col. 8, lines 66-68z0
As part of the delivery system, plasticizing agents are added "to facilitate processing by increasing the flexibility and toughness of the final product by internally modifying (solvating) the polymer molecule" (col. 6, lines 51-57), wherein suitable plasticizing agents include "mono-, di- and triglycerides, and the like" (col. 7, line 1).
The triglyceride may be present "in an amount up to about 3%, and preferably about
0.7%, by weight" (Id. at lines 5-8), as per claim 6.
It would have been obvious to include a water and plasticizer based on its art-recognized suitability for use in lozenges, as taught by Muhammad et al.
9) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,723,904. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising soluble fiber having a glass transition temperature greater than 37°C, including additives, e.g. triglycerides, and water.
10) Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,109,313. Although the claims at issue are not identical, they are not patentably distinct from each other because they both claim a lozenge comprising soluble fiber having a glass transition temperature greater than 37°C, including additives, e.g. triglycerides, and water.
Conclusion
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER E WEBB whose telephone number is (571)270-3287 and fax number is (571) 270-4287. The examiner can normally be reached from Mon-Fri 7-3:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Walter E. Webb
/WALTER E WEBB/Primary Examiner, Art Unit 1612
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