DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Remarks submitted with their Pre-Appeal Conference Request, filed 3 June 2026, 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.
No claims have been added, amended, or canceled. No new matter has been added.
Prosecution Reopened
Applicants’ request for reconsideration of the finality of the rejections of the preceding Office Action were deemed persuasive and, therefore, the finality of that action is withdrawn.
Thus, claims 1, 3-6, 8-10, 14, 17-20, 48, 49, 51, 53, and 54 continue to 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Withdrawn Rejections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 103
Each of the previously maintained obviousness rejections was reconsidered following the submission of Applicants’ Pre-Appeal Conference Request. Therein, Applicants’ filed remarks address the Examiner’s discussion of Andersson’s teachings of non-nicotine-based salts and that the use of these salts would provide the skilled artisan with an expectation that the resulting composition would possess a pH of greater than 6. It is Applicants’ contention that none of the references cited (e.g., Andersson) disclosed producing a composition that possessed a pH under 6.
None of the previous grounds of rejection of record clearly presented this teaching and as such, are withdrawn.
New Rejections
Applicants’ response has necessitated the following grounds of rejection:
Claim Rejections - 35 USC §112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL. — The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3-6, 8-10, 14, 17-20, 48, 49, 51, 53, and 54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claim 1, as currently amended, recites a nicotine-containing composition comprising:
a nicotinic compound;
a sugar substitute in an amount of at least about 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.
The composition is further limited such that:
the sugar substitute is a non-hygroscopic sugar alcohol capable of forming a glassy matrix;
the composition is in a pharmaceutically acceptable form adapted for oral delivery of the composition;
the composition is in the form of a hard-boiled lozenge;
the composition is translucent;
the sugar substitute and the sugar alcohol in syrup form are different sugar alcohols; and
the pharmaceutical composition has a pH of less than 6.
The claims are rejected as lacking written description with respect to “salts other than a nicotinic salt” as recited as it relates to the subsequently recited pH limitation. This limitation is presented in claim 1, and is therefore, present in each of the claims depending therefrom.
Both of independent claims 48 and 49 recite the same combination of salt and pH limitations.
As discussed in the previous rejection, Applicants’ originally-filed disclosure provides discussion pertaining to salts that possess functionality as buffers (see pg. 17, first paragraph). The specification also provides discussion directed at defining those salts which are considered to meet the limitation of nicotine salts (see pg. 12, lines 1-5; claim 53). Thus, for the purpose of considering the claims with respect to the prior art, the claims were broadly and reasonably considered to embody and be read on by any salt for component (d.) as long as it was not a nicotine-salt. Salts that impacted pH of the composition were included in this interpretation, owing to Applicants’ failure to directly disclose or define those salts that defined the exclusionary limitation, let alone those that would allow a person of ordinary skill in the art to produce the claimed composition having a pH of less than 6.
The Examiner acknowledges that MPEP §2163(I) states that in order “[t]o satisfy the written description requirement; a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.”
Additionally, MPEP §2163(II)(A)(3)(a)(ii) states that “[t]he written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus.”
“A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.”
Lastly, “[s]atisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed.”
Thus, what is lacking description in the claims is a representative number of species for “salts other than a nicotine salt” which may be formulated with the remaining defined compositional elements, the combination of which achieves the recited functional limitation of a dosage form having a pH of less than 6.
The limitations of claims 3-6, 8-10, 14, 17-20, 51, 53, and 54 are rejected as they depend either directly or indirectly from claim 1.
Claims 1, 3-6, 8-10, 14, 17-20, 48, 49, 51, 53, and 54 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The limitations recited by independent claims 1, 48, and 49 are discussed above.
At issue in each claim is the aforementioned limitation of the pharmaceutical composition having a pH of less than 6. This limitation is additionally combined with the required inclusion of a salt that is “other than a nicotine salt”.
The specification does not enable a person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims without undue experimentation. MPEP 2164.01(a), citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), sets out the factors to consider whether experimentation is undue, which include:
(A) The nature of the invention.
Briefly, as presented above, the claim in question is drawn to a nicotine-releasing composition comprising a nicotinic compound (i.e., nicotinic salt), a sugar substitute (i.e., isomalt), a sugar alcohol syrup derived from a sugar alcohol that differs from the sugar substitute (i.e., xylitol, maltitol), a salt other than a nicotinic salt, and a buffering agent selected from the group of amino acids, with the overall composition having a pH value that is less than 6.
(B) The breadth of the claims.
The breadth of scope of the instantly claimed composition is such that a person of ordinary skill in the art would require an inordinate amount of experimentation to practice it, based on the absence of guidance in the originally-filed disclosure (i.e., what formulations embodied by claims 1, 48, and 49 result in or produce a dosage form having a pH of less than 6).
(C) The level of predictability in the art.
The level of unpredictability as recognized by the state of the art is high.
Evidence in support of this position is presented, for instance, by the references cited below in the forthcoming obviousness rejection. Therein, both the teachings of Liu (US Pre-Grant Publication Nº 2004/0101543 A1; of record), and more critically, Andersson et al. (US Pre-Grant Publication Nº 2008/0286340 A1), highlight the state of and lack of predictability in the art with respect to the pH values of such formulations.
The practiced formulations of Liu are defined as providing a mouth saliva pH of from above 7.0 to about 12.0, preferably above 7.0 to about 11.0. See ¶[0035].
Andersson also discloses oral, hard-boiled candy formulations comprising nicotine bitartrate dihydrate, isomalt, maltitol, flavoring agent, and an amino acid buffering agent (see claims 1 and 19). Paragraph [0068] additionally teaches that:
Further embodiments of the invention includes oral dosage forms being buffered with an amino acid in combination with other buffers, preferably selected from the group consisting of a carbonate including bicarbonate or sesquicarbonate, phosphate, glycerophosphate or citrate of an alkali metal, such as potassium or sodium, or ammonium, and mixtures thereof.
Included in this disclosure is a teaching and suggestion of using sodium or potassium citrates. However, citrate anion is capable of binding three cations, and exemplifying sodium, can be mono-, di-, or trisodium citrate, each of which have different pH values with monosodium citrate being the most acidic.
Regarding the buffering system employed by Andersson, ¶[0060] states the following:
Absorption of nicotine from the oral cavity to the systemic circulation is dependent on the pH of the saliva, pH of the blood plasma and the acid-base equilibrium of nicotine, which is about pKa=7.8 at 37° C. Assuming a pH of the saliva of 6.8, only about 10% of the nicotine will be in the non-charged base form. Thus, in order to promote absorption of nicotine in a free base form, which is the form predominantly absorbed through the mucosa, the pH of the saliva must be increased. At a pH of 9.0 more than 90% of the nicotine will be in the free readily absorbable base form.
Following on Applicants’ traversal of the now-withdrawn obviousness rejections, Andersson’s compositions employ salts that are inherently basic in order to drive up the overall pH of the practiced compositions.
Such a disclosure presents the ordinarily skilled artisan with a reasonable expectation that a higher, rather than a lower, pH value for the instant formulation will enable the claimed invention, Applicants’ desired outcome is nicotine absorption directly within the oral cavity.
As has been maintained throughout prosecution, Andersson discloses the compositional elements of each of claims 1, 48, and 49. However, the added requirement of the dosage form having a pH of less than 6, coupled with the non-nicotine salt limitation, places undue experimentation on the skilled artisan to discern what salt tips the composition to a pH of less than 6 and still allows for the absorption of nicotine in the oral cavity.
Adding to the unpredictability of the instantly claimed invention is the fact that Applicants do not provide a representative number of species describing those salts that are meant to be embodied by the limitation.
Thus, based on the evidence available in the state of the art, the Examiner concludes that the level of unpredictability instantly claimed composition is high.
(D) The amount of direction provided by the inventor.
Applicants’ instant specification provides no guidance, examples, or embodiments of formulations having a pH value within the recited range.
As discussed in the above written description rejection, the originally-filed disclosure fails to define those salts that are representative of the non-nicotine salts limitation present within the independent claims, especially those salts that help produce a dosage form having a pH of less than 6.
Applicants’ disclosure also contains only six examples (see pg. 28, Table 1). Each of these examples is noted as not employing any amino acids (“buffering agents”) and the one non-nicotine salt that is used is sodium carbonate (pH of 9.6-12.5) (www.scrippslabs.com/ph-of-common-reagents-at-room-temperature/).
(E) The quantity of experimentation needed to make or use the invention.
Having considered the contributions of the state of the art as well as the sparing guidance provided in the originally-filed disclosure, the Examiner submits that a high quantity of experimentation would be required to make and/or use a composition having a non-nicotine salt and a pH less than 6.
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 1, 3-6, 8-10, 14, 17-20, 48, 49, 51, 53, and 54 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.
The limitations recited by independent claims 1, 48, and 49 are discussed above. Of particular note is that each independent claim recites the limitation of including ‘a salt that is not a nicotine salt’ whereby the totality of the composition containing said salt has a pH of less than 6.
As discussed above, Applicants’ originally-filed disclosure provides discussion which defines species of nicotine salts (nicotine salts are recited as being a species of the recited nicotinic compound). The same disclosure is also acknowledged as providing discussion pertaining to salts that also function as buffering agents. However, it should be noted that there is no language in the specification defining “a salt other than a nicotine salt.” Thus, in so defining these “non-nicotine salts,” it is noted (and argued by Applicants) that these salts possess pH values that exceed a pH of 6; they are basic (see pg. 17). Common table salt (pH = 7) is listed as are other oxide, hydroxide, carbonate, and bicarbonate salts of alkali metals.
Thus, the claimed compositions are rendered indefinite since it is unclear exactly which salts Applicants consider to be part of the instant invention.
The limitations of claims 3-6, 8-10, 14, 17-20, 51, 53, and 54 are rejected as they depend either directly or indirectly from claim 1.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
Due to the new grounds of rejection, this action is deemed non-final.
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
Prosecution Insights