DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 1 December 2025, in the matter of Application N° 16/220,387. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application is being examined under the pre-AIA first to invent provisions.
Claims 55 and 56 have been canceled. The limitations of claim 56 reciting that the composition has a pH of less than 6 has been amended into each of independent claims 1, 48, and 49.
Claims 1, 48, and 49 have been additionally amended to further limit the salt component to be one that is other than a nicotine salt. Support for this limitation is provided in the claims as well as the originally-filed disclosure. Page 17 (first paragraph) states that common table salt (NaCl) is typically used, but also that “[a]ny type of salt can be used.”
No claims have been added. No new matter has been added.
Thus, claims 1, 3-6, 8-10, 14, 17-20, 48, 49, 51, 53, and 54 now represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Withdrawn Rejections
Rejections under 35 USC 112(a)
Applicants’ amendment cancelling claim 56 is sufficient in overcoming the previously raised enablement and written description rejections. Said rejections are withdrawn.
Rejection under 35 USC 102(a)/(b)/(e)
Applicants’ amendment discussed above which further specifies that the “salt” is one that is “other than a nicotine salt” is sufficient in overcoming the previously raised anticipation rejection. Said rejection is withdrawn.
Rejections under 35 USC 103
Applicants’ amendment discussed above which further specifies that the “salt” is one that is “other than a nicotine salt” is sufficient in overcoming the previously raised anticipation rejection. Said rejections are withdrawn.
New Rejections
Applicants’ amendments have necessitated the following ground(s) of rejection:
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 6, 8, 10, 14, 17, 18, 48, 49, 51, 53, and 54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Andersson et al. (US Pre-Grant Publication Nº 2008/0286340 A1; of record).
As amended, the limitations of the claimed invention are directed to a nicotine-containing composition comprising:
a nicotinic compound;
a sugar substitute in an amount of at least 80% by weight;
a sugar alcohol syrup;
a salt other than a nicotine salt; and
a buffering agent selected from the group consisting of arginine, asparagine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, valine, cysteic acid, N-glycylglycine, ornithine, and combinations thereof;
wherein the sugar alcohol and sugar substitute are different sugar alcohols (e.g., isomalt and maltitol).
The recited composition further characterizes the sugar substitute as being a non-hygroscopic sugar alcohol capable of forming a glassy matrix (e.g., isomalt). The composition is additionally recited as being in the form of an orally administered, hard-boiled lozenge, that is translucent. Lastly, the composition recites the property of having a pH that is less than 6.
Regarding the pH limitation, looking to Applicants’ instant specification, the limitation appears to be a property and/or functional limitation that is tethered to and definitive of the instantly encompassed composition discussed therein (see Spec., pg. 17, line 11 to pg. 18, line 11). As such, consistent with MPEP §2111.01(IV), §2112.01(I) and (II), and §2173.05(g), the Examiner submits that where Applicants’ defining composition is disclosed in the prior art, the recited pH limitation of the claims, will also be considered met.
Both independent claims 48 and 49 recite the newly provided amendment of a salt other than a nicotine salt, and a pH of less than 6.
Regarding the “consisting essentially of” transition phrase recited in claims 48 and 49, it is noted that Examiner will read the transition phrase “consisting essentially of” as “comprising” until Applicants disclose the materials or steps that materially affect the basic and novel characteristics of the claimed invention. See MPEP 2111.03(III).
Andersson discloses oral formulations that may be in the form of a hard-boiled candy or lozenge (see e.g., claims 1, 16, and 19). Claim 19 and Example 5 exemplify teachings, as previously discussed, whereby hard-boiled candies will contain nicotine bitartrate dihydrate, isomalt in an amount of 78 wt% of the candy (i.e., at least about 80% by weight), maltitol, and an amino acid (e.g., L-arginine). The foregoing meets the compositional merits of parts a-c, and e of claims 1 and 48, and parts a-d of claim 49. Regarding the recited buffer compounds of claims 1, 48, and 49, Andersson additionally discloses that the at least one endogenous amino acid may be selected from asparagine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, valine, cysteic acid, N-glycylglycine, and ornithine (see e.g., claims 3 and 4).
The foregoing is considered to also read on the limitations of claims 6, 8, 10, 53, and 54.
Regarding the amended salt component of the claimed invention (part d of claims 1 and 48, and part g of claim 49), the Examiner notes that this limitation is defined by the instant specification as discussed above and that the broadest reasonable interpretation of the salt is that it is embodied by any salt except for a nicotine salt.
Andersson meets this limitation disclosing, for instance, in ¶[0068] that oral dosage forms being buffered with an amino acid may be done so in combination with other buffers that are preferably selected from carbonates and bicarbonates of an alkali metal such as potassium, or sodium or ammonium, and combinations thereof (see also claim 7 and ¶[0070]-¶[0071]).
Regarding the remaining compositional and structural limitations of claim 1, the Examiner submits that the disclosure of isomalt meets the limitation reciting “wherein the sugar substitute is a non-hygroscopic sugar alcohol capable of forming a glassy matrix. The disclosure of maltitol and isomalt in the same formulation (e.g., Example 5 and claim 19), is considered to meet the limitation requiring that the sugar substitute and the sugar alcohol syrup form are different sugar alcohols.
Andersson expressly discloses that the practiced formulations are “configured” for oral delivery (e.g., hard-boiled lozenge).
Lastly, like the recited pH property, the translucent property of the practiced composition is considered to be met as the compositional and structural limitations have also been met. See MPEP §2112.01(I).
Claim 19 and Example 5 additionally disclose the use of a flavorant, thereby reading on the limitations of claim 14, and part f of claim 49.
Paragraph [0093] discloses that sweeteners are added to essentially improve taste and lists sucralose as one such sweetener, thereby meeting the limitations recited by claims 17, 18, and part e of claim 49.
Paragraph [0091] discloses a list of other optional additives that may be used in the practiced oral formulations, among which are listed thickening agents, film forming agents, and binders. As these are disclosed as being optional, they are interpreted as also being absent from the practiced composition, thereby meeting the limitations of claim 51.
Based on the foregoing teachings of Andersson, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition.
The Examiner again acknowledges that Applicants’ amended compositions recite possessing a pH of less than 6. However, the Examiner respectfully advances that the claimed invention remains compositionally and structurally indistinct from the practiced invention of Andersson, most notably with respect to the amino acids available to operate as buffering agents.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Claims 1, 3, 6, 8-10, 14, 17, 48, 49, 51, 53, and 54 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Liu et al. (US Pre-Grant Publication Nº 2004/0101543 A1; of record), further in view of Andersson et al. (US Pre-Grant Publication Nº 2008/0286340 A1; of record).
The limitations of the claimed invention are directed to a nicotine-containing composition comprising:
a nicotinic compound;
a sugar substitute in an amount of at least 80% by weight;
a sugar alcohol syrup;
a salt; and
a buffering agent selected from the group consisting of arginine, asparagine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, valine, cysteic acid, N-glycylglycine, ornithine, and combinations thereof.
The recited composition further characterizes the sugar substitute as being a non-hygroscopic sugar alcohol capable of forming a glassy matrix (e.g., isomalt). The composition is additionally recited as being in the form of an orally administered, hard-boiled lozenge, that is translucent. Lastly, the sugar alcohol and sugar substitute are different sugar alcohols (e.g., isomalt and maltitol).
Liu teaches a solid oral dosage form comprising a glassy matrix comprising at least one substantially non-hygroscopic sugar alcohol capable of forming a glassy structure and a nicotine active (see e.g., ¶[0019]-¶[0021]).
Regarding claims 1, 6, 9, and 48 Liu discloses up to 99% of a sugar substitute such as isomalt (see ¶[0026]).
Regarding claims 1, 8, 10, and 48, xylitol is disclosed at a concentration of 1-20% (see e.g., claim 17 of Liu).
Isomalt as sugar substitute and xylitol as sugar alcohol suggests the recited limitation to claim 1, “wherein the sugar substitute and the sugar alcohol in syrup form are different sugar alcohols.”
Regarding the sugar alcohol syrup of claim 1, Liu teaches that “in one suitable fire cooker method, the desired quantity of the substantially non-hygroscopic sugar alcohol and any other sugar components are dissolved in water by heating them in a kettle until dissolved. Additional sugar components may be added and cooking continued until a final temperature of about 145ºC-165ºC is achieved. The mix is then cooled, worked as a plastic-like mass, and admixed with the nicotine active and optional ingredients such as flavors, colorants, buffer, etc.” See ¶[0062]. Please note that “other sugar components” include sugar alcohols, such as sorbitol and xylitol (see ¶[0037]).
Regarding claim 1, the product may be transparent (see [0065]).
Regarding claims 1-3 and 48, the nicotinic compound may be a salt, such as nicotine polacrilex (see ¶[0029]-¶[0030]). Pursuant to the definition provided by Applicants’ original disclosure for a “salt,” the Examiner submits that the foregoing also meets the newly added “salt” limitation of claims 1, 48, and 49.
Additionally, regarding claims 53 and 54, the reference discloses and defines the “nicotine active” as including nicotine salt derivatives such as nicotine bitartrate dihydrate salt. See ¶[0029] and ¶[0073] of Example 1.
Regarding the hard-boiled claim 1, lozenges are disclosed (see ¶[0022]) wherein the composition is cooked to a final temperature of 145ºC-165ºC (see ¶[0062]).
Regarding claim 14, flavoring agents such as mint are disclosed at a concentration of 0.5-5% (see ¶[0040]).
Regarding claims 17 and 49, flavoring agents and sweeteners are disclosed as being part of the practiced compositions (see e.g., ¶[0034]). Paragraph [0039] discloses further that high intensity sweeteners are useful for improving the sweetness profile of the practiced composition.
Regarding claim 51, Liu does not require a thickener, film former, or binder.
Regarding the “consisting essentially of” transition phrase recited in claims 48 and 49, it is noted that Examiner will read the transition phrase “consisting essentially of” as “comprising” until Applicants disclose the materials or steps that materially affect the basic and novel characteristics of the claimed invention. See MPEP 2111.03(III).
Regarding claims 1, 48, and 49, the reference, like Andersson is noted as not expressly disclosing that the resulting products possess the amended property of having a pH less than 6. However, like Andersson, Liu also discloses compounds that are used to effect this buffering property are disclosed, for instance, in claim 15.
Where Liu departs from the instantly amended invention is with respect to the buffering agent being defined as one or more amino acids. Andersson is considered to bridge the gap in teachings.
Andersson, like Liu, is directed to buffered, nicotine-containing products that are administered orally in different formulations, such as hard-boiled lozenges. Notably, Andersson discloses a nicotine hard-boiled, candy comprising nicotine bitartrate dihydrate, isomalt, maltitol, an amino acid, and flavoring agent (see e.g., claim 19). Example 5, for instance, discloses that isomalt is present in a hard-boiled preparation in an amount of 78 wt% of the composition, thereby meeting the recited “at least about 80% by weight” limitation of claim 1.
As disclosed in claims 1-3 and 19, the composition is buffered using amino acids, which according to claim 3, disclose arginine, asparagine, glutamic acid, glutamine, glycine, histidine, isoleucine, leucine, lysine, methionine, phenylalanine, serine, threonine, and valine. Claim 4 further discloses that the amino acid buffering agent may be cysteic acid, glycylglycine, and ornithine.
The Examiner additionally notes that the practiced oral formulation is later taught as further comprising additional buffers such as carbonates, bicarbonates, glycinate, phosphates, citrate, alkali metals, calcium hydroxide, sodium glycinate, and mixtures thereof (see e.g., claim 7).
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition. Motivation to modify the composition disclosed by Liu is taken from Andersson’s disclosure whereby every one of the amended amino acids is disclosed for the purpose of operating as a buffering agent to the deliverable nicotine-based compound. The Examiner notes, as above, that buffering compounds such as those disclosed by Liu are also disclosed by Andersson, and as being optionally later added to be in combination with the amino acid buffering agents. However, the Examiner considers this to be an optional addition to the disclosed composition, and further, a disclosure that more than suggests that amino acids are functional alternative to inorganic buffering agents that are disclosed by Liu and Andersson. The Examiner finds support for this position in both Liu and Andersson, ¶[0035] and ¶[0060], respectively. Both citations expressly disclose that the buffering agent(s) used raise the pH of mouth saliva to which the buffered nicotine products are administered.
MPEP §2144.06(II) states that “[i]n order to rely on equivalence as a rationale supporting an obviousness rejection, the equivalency must be recognized in the prior art, and cannot be based on Applicants’ disclosure or the mere fact that the components at issue are functional or mechanical equivalents.”
In the instant case, the Examiner has not only provided a showing that suggests that amino acids of Andersson would operate as substitutes for the inorganic acids of Liu, said showing provides motivation for why the skilled artisan would expect improved absorption of the delivered nicotine compound.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Claims 17-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Liu et al. (US Pre-Grant Publication Nº 2004/0101543 A1; of record) and Andersson et al. (US Pre-Grant Publication Nº 2008/0286340 A1; of record), as applied to claim 1 above, and further in view of Chan et al. (US Pre-Grant Publication Nº 2005/0123502 A1; of record).
The limitations of amended claims 1 and are discussed above. Claim 18 recites that the sweetener is sucralose. Claims 19 and 20 recite that the salt of claim 1 is sodium chloride and that it is present in an amount ranging from about 0.5% to about 1% by weight of the composition.
The teachings of Liu and Andersson are discussed above. Liu differs from the instant claims in that it does not teach the sweetener of claim 18 and the sodium chloride species of salt recited by claims 19 and 20.
Chan remedies these deficiencies by teaching an oral composition that comprises a nicotine active (see, e.g. ¶[0009]). The composition may be in the form of a lozenge (see ¶[0050]).
Regarding claims 17 and 18 Chan discloses sweeteners such as sucralose (see ¶[0069]).
Regarding claims 19 and 20 Chan discloses sodium chloride at a concentration of 0.5%, overlapping with the concentration recited in claim 20 (see ¶[0024]).
Regarding the “consisting essentially of” transition phrase recited in claim 49, it is noted that Examiner will read the transition phrase “consisting essentially of” as “comprising” until Applicants disclose the materials or steps that materially affect the basic and novel characteristics of the claimed invention. See MPEP §2111.03(III).
It would have been obvious to a person of ordinary skill in the art at the time the invention was filed to make a nicotine containing composition as recited in claim 1, further comprising sucralose as a sweetener and sodium chloride as a salt as taught by Liu in view of Chan. One of ordinary skill in the art at the time the invention was made would have been motivated to make such a composition because it dissolves more rapidly than commercially available compressed nicotine tablets, as explained by Liu (see ¶[0023]).
Liu additionally is noted above as disclosing the use of sweeteners, specifically “high-intensity sweeteners such as saccharin, aspartame, and acesulfame-K. Liu simply does not expressly mention sucralose as a high-intensity sweetener. Chan remedies this deficiency in its disclosure.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Claims 4 and 5 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Liu et al. (US Pre-Grant Publication Nº 2004/0101543 A1; of record) and Andersson et al. (US Pre-Grant Publication Nº 2008/0286340 A1; of record), as applied to claim 1 above, and further in view of Hansson et al. (US Pre-Grant Publication Nº 2004/0191322 A1; of record).
The limitations of amended claims 1 and are discussed above. Claim 4 recites that the nicotinic compound is sorbed onto a porous particulate carrier. Claim 5 defines the particulate carrier as microcrystalline cellulose.
The teachings of Liu and Andersson are discussed above. These references differ from the instant claims in that they do not teach a porous particulate carrier.
Hansson remedies this deficiency by teaching a nicotine-containing particulate material for release of nicotine the material comprising a combination of nicotine or a pharmaceutically acceptable salt, complex or solvate thereof and a microcrystalline cellulose (see, e.g., Abstract).
Regarding claims 4 and 5, Hansson additionally teaches sorption of nicotine in the form of a solution containing nicotine as a base on a microcrystalline cellulose (see e.g., ¶[0010]). Hansson explains that sorption of nicotine on microcrystalline cellulose particles is beneficial because it results in a physical and chemically stable dry particulate material with a very fast and complete release (see e.g., ¶[0010]).
It would have been obvious to a person of ordinary skill in the art at the time the invention was filed to disclose a nicotine containing composition comprising a nicotinic compound (such as nicotine polacrilex), a sugar substitute, and a sugar alcohol syrup, and additionally a flavoring agent, and a salt, wherein the nicotine is sorbed onto a porous particulate carrier as taught by Liu and Andersson, further in view of Hansson. One of ordinary skill in the art at the time the invention was made would have been motivated to make such a composition because it is stable and provides controlled buccal delivery of a drug, as explained by Dam (see above). Additionally, one of ordinary skill in the art at the time the invention was made would have been motivated to sorb nicotine onto porous particulate carriers because it results in a physical and chemically stable dry particulate material with a very fast and complete release, as explained by Hansson (see above).
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
All claims have been rejected; no claims are allowed.
Conclusion
Applicants’ amendments 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615