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 .
Status of Claims
The arguments filed 04/07/2026 are acknowledged and have been fully considered. Claims 1-12, 14, and 17-26 are currently pending. Claim 1 is amended; claims 13 and 15-16 are cancelled; claims 8-12, 14, 17, and 19-26 are withdrawn; no claims are new.
Claims 1-7 and 18 are examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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.
Claims 1-7 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Us Patent 9888712 (Zimmermann, 2018; of record) in view of Okeke (2016), US PGPUB 20220071272 A1 (Castelijn, 2020), and CN 112574475 A (Wang, 2021) and as evidenced by Kramer Industries (“Mesh Size”; of record).
Claim 1 is drawn to a method of preparing an agglomerated botanical material having an increased water stability, comprising:
combining botanical particle fines (more specifically stems of a plant of the Nicotiana species (Claim 18)) having an average size of about 300 microns or less with a binding agent, the binding agent being an alginate salt combined with hydroxypropyl methyl cellulose;
forming agglomerated botanical particles from the combined botanical particle fines and binding agent, the agglomerated botanical particles having an average particle size greater than the botanical particle fines; and
treating the agglomerated botanical particles to increase the water stability thereof, wherein the treating step comprises treating the agglomerated botanical particles with a divalent cation solution comprising calcium chloride at a temperature of about 50°C or greater.
Zimmermann teaches a method for forming tobacco (i.e., a species of Nicotiana) beads (see Zimmermann, Col. 1 lines 29-32). Zimmermann further teaches “Preferably, the tobacco beads 14 are made of an agglomeration of tobacco fines and water. In one embodiment, the tobacco beads 14 may also include flavorants 16. In a preferred embodiment, the tobacco beads 14 include a binder 18” (see Zimmermann, Col. 4 lines 23-27) and “The tobacco beads 14 can be prepared using known extrusion and spheronization processes for producing pharmaceutical pellets and flavored beads” (see Zimmermann, Col. 4 lines 38-40). Zimmermann defines tobacco fines as “small tobacco particles that are too small for inclusion in tobacco products” (see Zimmermann, Col. 3 lines 64-65) and further teaches “Particles of less than about 60 mesh tend to go airborne during pouching operations, thereby wasting tobacco and creating cleanliness issues during pouching operations. Thus, tobacco particles below 60 mesh are preferably separated out prior to pouching. These particles, which would otherwise be waste, can be formed into tobacco beads using the processes described herein” (see Zimmermann, Col. 4 lines 11-15). As evidenced by Kramer Industries particles smaller than 60 mesh are smaller than 250 micron (see Kramer Industries, Table on pg. 2), and would necessarily have an average size less than 300 microns. The tobacco beads of Zimmermann are “more preferably about 0.3 mm to about 0.7 mm” (see Zimmermann, Col. 4 lines 66-67), and would necessarily have an average size larger than the claimed 300 micron size of the fines. Zimmermann further teaches “The loose, fibrous tobacco material may be provided in any suitable form, including, but not limited to, tobacco lamina, processed tobacco materials such as volume expanded or puffed tobacco, aged tobacco, processed tobacco stems, such as cut-rolled or cut-puffed stems, reconstituted tobacco materials, blends thereof, and the like” (see Zimmermann, Col. 8 lines 39-45, emphasis added).
As such, Zimmermann teaches a method of preparing an agglomerated botanical material, comprising combining botanical particle fines comprising stems of a plant of the Nicotiana species (tobacco) having an average size of about 300 microns or less with a binding agent; and forming agglomerated botanical particles from the combined botanical particle fines and binding agent, the agglomerated botanical particles having an average particles size greater than the botanical particle fines.
The method of Zimmermann differs from the instantly claimed method in the following ways:
Zimmermann does not teach the binder agent being an alginate salt combined with hydroxypropyl methyl cellulose, however Zimmermann teaches that hydroxypropyl methylcellulose (HPMC) is used as a binder in the composition (see Zimmermann, Col. 5, lines 13-33); and
Zimmermann does not teach a step of treating with a divalent cation solution comprising calcium chloride.
In regards to point 1, Okeke teaches that HPMC and sodium alginate (SA) are known mucoadhesive polymers used with nicotine (see Okeke, abstract; page 32, col. 1, paragraph 2). Okeke also teaches that “[t]he properties of mucoadhesive polymers such as surface charge and solubility play a vital role in their ability to adhere to mucosal surfaces. Charged polymers such as SA demonstrate higher adhesion than non-ionic polymers (e.g. HPMC), because of their ability to form a strong electrostatic interaction with the charged surface of mucin. The use of composite polymeric systems can be adopted to enhance the functional properties of a polymeric dosage form. HPMC is very effective in designing controlled drug delivery systems while SA can be used to enhance the mucoadhesion of a given polymeric dosage form. Further, the anionic nature of SA provides a potential means of interaction of the amine groups of NIC with the carboxylic acid side chains of SA, which could improve mucoadhesion and provide further control of drug release” (see Okeke, page 32, col. 1, paragraph 2).
In regards to point 2, Castelijn teaches a method of making a tobacco product (see Castelijn, abstract), such as a pouch comprising a binder such as alginate (see Castelijn, paragraph 0135). The method comprises milling tobacco material and extracting tobacco pulp with a chelating agent, wherein the chelating agent is calcium citrate, calcium diacetate, calcium hexametaphosphate, or monobasic calcium phosphate, among others (see Castelijn, figure 1; paragraphs 0068 and 0085). It is taught that the chelating agent removes transition metals from the tobacco material (see Castelijn, paragraphs 0043 and 0068). It is also taught that the extraction done with water and a chelating agent is done at a temperature of about 75°C to about 100°C (see Castelijn, paragraphs 0068-0070). MPEP 2144.05 states that "[i]n the case where the claimed ranges 'overlap or lie inside ranges disclosed by the prior art' a prima facie case of obviousness exists" quoting In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Wang teaches a method of chelating tobacco products with calcium chloride (see Wang, abstract; page 2, contents of the invention, paragraph 4).
In regards to claims 1 and 18, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Zimmermann with the teachings of Okeke, Castelijn, and Wang to formulate the instant method. Particularly, it would be obvious to one with ordinary skill in the art to use the combination of HPMC with SA as a binder as Okeke teaches that using both together improves mucoadhesion while also providing further control for the release of the drug (see Okeke, page 32, col. 1, paragraph 2). Also, one with ordinary skill in the art would be motivated to add the chelating step of Castelijn to the method of Zimmermann as it would remove transition metals from the tobacco material using one of the chelating agents mentioned, such as calcium chloride as it is known to work as a chelating agent with tobacco products (see Castelijn, paragraphs 0068-0070; Wang, page 2, contents of the invention, paragraph 4). One with ordinary skill in the art would be motivated to combine the method of Zimmermann with the HPMC and SA of Okeke and the chelating step of Castelijn with chelating agent of Wang according to the method of making a tobacco product (see Zimmermann, Col. 4, lines 44-56) to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Further in regards to the use of the chelating agent of Wang, it would be obvious to one with ordinary skill in the art to simply substitute one known chelating agent for another, particularly when both are used for tobacco products, to obtain predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to simply substitute one known element for another to obtain predictable results.
In regards to the limitation of the agglomerated botanical particles to gel the binding agent, Zimmermann teaches that the tobacco beads include a binder (see Zimmermann, Col. 4 lines 23-27) and the teachings of Okeke, Castelijn, and Wang would motivate one with ordinary skill in the art to use calcium chloride at a temperature of 50°C or higher as claimed, one with ordinary skill in the art would understand that the binding agent would behave in the same manner when used in the same method. MPEP §2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” As the the prior art renders obvious the instant composition, a person of ordinary skill in the art would reasonably expect the same composition to have the same properties as instantly claimed.
Claim 2 is drawn to the method of claim 1, wherein the combining step comprises combing the botanical particle fines with the binding agent at a weight ratio of botanical particle fines to binding agent of from about 0.5:1 to about 5:1.
Claim 3 is drawn to the method of claim 1, wherein the combining step comprises combing the botanical particle fines with the binding agent at a weight ratio of botanical particle fines to binding agent of from about 0.8:1 to about 3.25:1.
Claim 4 is drawn to the method of claim 1, wherein the combining step comprises combing the botanical particle fines with the binding agent at a weight ratio of botanical particle fines to binding agent of about 3.25 or less.
Zimmermann further teaches “For tobacco beads, which include a binder additive, preferably, about 5 wt % to about 90 wt % of the tobacco bead is tobacco particles, and more preferably from about 30 weight % to about 65 weight % of the tobacco bead is tobacco particles” (see Zimmermann, Col. 4 lines 34-37). 30 wt% to 65 wt% of tobacco particles corresponds to a weight ratio of tobacco particles to binding agent of about 0.42:1 to about 1.86:1 as calculated by examiner, overlapping with the instantly claimed ranges of about 0.5:1 to about 5:1, about 0.8:1 to about 3.25:1, and about 3.25 or less.
As such, claims 2-4 are rejected as prima facie obvious.
Claim 5 is drawn to the method of claim 1, wherein the agglomerated botanical particles have an average particle size greater than about 350 microns.
Claim 6 is drawn to the method of claim 1, wherein the agglomerated botanical particles have an average particle size greater than about 400 microns.
Claim 7 is drawn to the method of claim 1, wherein the agglomerated botanical particles have an average particle size greater than about 500 microns.
Zimmermann teaches “each spheroidal tobacco bead can have a diameter of about 0.1 mm to about 2.5 mm” (see Zimmermann, Col. 4 lines 64-65), corresponding to 100 to 1500 microns. One of ordinary skill in the art would reasonably expect the average tobacco bead to have an average particle size greater than 500 microns.
Assuming, arguendo that the tobacco beads of Zimmermann do not have an average size greater than 500 microns, MPEP 2144.04 states “In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.” In the instant case, one of ordinary skill in the art would expect the 0.1 mm to 2.5 mm tobacco beads to perform the same as the instantly claimed agglomerated particles having an average particle size greater than about 500 microns.
As such, claims 5-7 are rejected as prima facie obvious.
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s argument that the method of the prior art would not motivate one with ordinary skill in the art to use the treatment of the agglomerate particles to gel the binder agent as the art does not teach that the chelating agent (i.e., treatment with calcium chloride) would be done in the presence of the binder with the tobacco particles (specifically in Castelijn), the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In the instant case, Zimmermann teaches that the tobacco beads include a binder (see Zimmermann, Col. 4 lines 23-27) and the teachings of Okeke, Castelijn, and Wang would motivate one with ordinary skill in the art to use calcium chloride at a temperature of 50°C or higher as claimed, one with ordinary skill in the art would understand that the binding agent would behave in the same manner when used in the same method. MPEP §2112.01(I) states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” As the prior art renders obvious the instant composition, a person of ordinary skill in the art would reasonably expect the same composition to have the same properties as instantly claimed.
Applicant also argues that the treatment is not taught to gel the binding agent, however again, as the method described in the prior art is identical to the claims, a person of ordinary skill in the art would reasonably expect the same composition to have the same properties as instantly claimed, since materials/compounds and their properties are inseparable and cannot have mutually exclusive characteristics.
In response to applicant's argument that Okeke is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, although Okeke is not in the same field of endeavor, it is reasonably pertinent to the problem to be solved with regards using mucoadhesive polymers with nicotine to increase adhesion to mucosal surfaces. A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023).
As such, the method of the instant claim is rendered obvious and is not allowed.
Conclusion
No claims allowed.
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.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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