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 the Claims
Claims 1, 3, 10, 22, 26, 45, 46, 48, 53-55 and 64-69 are pending.
Claims 45, 46, 48, 53-55 and 64 are withdrawn.
Claim Rejections - 35 USC § 112
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 26 and 65 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.
It is not clear if the pouch is transparent or translucent because claim 26 states that the pouch is transparent, however, claim 65 which depends on claim 26 states that the pouch is transparent or translucent.
For purposes of examination, it is interpreted that the pouch is transparent.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 26 and 65 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 26 states that the pouch is transparent, however, claim 65 which depends on claim 26 states that the pouch is transparent or translucent, which is broader than claim 26.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For purposes of examination, it is interpreted that the pouch is transparent.
Response to Arguments
Applicant's arguments filed 1/5/26 have been fully considered but they are not persuasive.
Applicant Argument A:
A person of ordinary skill would not have modified '756 as alleged by the Examiner. In contrast to the Examiner's allegation, the Examiner's proposed modification of the '756 would have rendered the '756 unsuitable for its intended purpose and there is no motivation to have combined these references. For example, the '756 makes clear that its formulations "solve the problem of unsatisfactory therapeutic effect" where "the nicotine mixture provided by the present invention can jointly provide nicotine through nicotine immediate-release granules and nicotine sustained-release granules, wherein the nicotine immediate-release granules can quickly supply nicotine so that the...concentration of nicotine in the human blood can reach the effective range within a short period of time, so that the human body can quickly obtain pleasure, and the subsequent nicotine sustained-release particles can release nicotine for a long time to maintain the nicotine content in the human blood in a therapeutic range." See p. 3. However, the Examiner's proposed modifications of '756 (which, notably, has not identified which of '756 granules would have been modified), would fundamentally change the release properties of '756's purpose, to provide specific therapeutic release rates, rendering '756 granules unintended for their proposed purpose. Accordingly, there is no motivation to have combined these references.
For example, Duan explains that "hydroxypropyl methyl cellulose helps control the flavor release rate" due to its "higher solubility in saliva than MCC" such that the "hydroxypropyl methyl cellulose dissolves more quickly thereby releasing the flavorant more quickly." See [0014]. Similarly, "it is believed that the addition of a first starch and/or a second starch aids in controlling the flavor release rate of the flavor beads... [s]ince the pectin and/or sodium alginate are cross- linked during ionic gelation, the starches have a higher solubility and thus release flavorants at a different release than pectin and/or sodium alginate." See [0021]. Presuming Duan's "flavorants" are relevant to nicotine (which Applicant does not concede particularly considering Duan does not describe the use of actives such as nicotine), Duan makes clear that the proposed modification would dramatically change dissolution rates of the '756 granules. There is no basis whatsoever to contend that a person of ordinary skill in the art would include these components in '756, which change the narrow dissolution rates associated with the purpose of the '756 patent.
Moreover, Examiner appears to allege that a person of ordinary skill in the art would incorporate microcrystalline cellulose and modified starches based on Duan's disclosure. However, Duan makes clear that any benefit of these starches is entirely associated with "pectin or sodium alginate." However, those components are not claimed in the recited systems. There is no basis, whatsoever, to contend that a person of ordinary skill in the art would have incorporated modified starches into the recited compositions for at least the reason that pectin or sodium alginate are not recited (or any benefit would have been thought to have been associated therewith).
Examiner Response A:
The Examiner respectfully disagrees. Mishra, not Duan, is relied upon for substituting the binder. Mishra teaches that the binder in the granules of the smokeless tobacco product is MCC or gum Arabic or gelatin [0021]. ‘756 teaches that the binder in the granules is gum Arabic or gelatin. Thus, Mishra is relied upon to teach substituting MCC for gum Arabic or gelatin in the granules of the smokeless tobacco product pouch. This is based on the teachings of Mishra, not Duan.
‘756 teaches the incorporation of polymer, but does not expressly teach that the polymer is a combination of OSA-starch and HPMC. Duan is relied upon to teach applying HPMC and OSA starch as the polymers in modified ‘756 with a reasonable expectation of success and predictable results, specifically because HPMC and OSA starch both provide a smooth and creamy texture to the beads and have excellent emulsification properties ([0014] and [0023]).
Applicant Argument B:
Separate consideration is requested for claim 22 which specifies that more than 95% of the particles comprise specific weight percentages of specific components. The Examiner alleges "it would have been obvious to have included MCC in an amount of at least 50% by weight in addition to the polymers in '756 because MCC improves the physical strength, integrity, and processability of the beads." See OA at 8. However, the claim specifies that more than 95% of the beads have these components, in these weight percentages. The '756, in contrast, "is mainly prepared by mixing nicotine immediate-release granules and nicotine sustained-release granules in a ratio of 1:9-9:1 by weight." See 1. The '756's "nicotine immediate-release granules" and "nicotine sustained-release granules" have different components and, there is no basis, whatsoever, to allege that '756 teaches or suggests a plurality of particles having more than 95% particles with the recited components (and, as explained above, any modification of '756 in the manner suggested by the Examiner would frustrate its purpose). Accordingly, the rejection is deficient and withdrawal is warranted.
Examiner Response B:
The Examiner respectfully disagrees. While the prior art ‘756 discloses two types of particles, claim 1 and claim 22 is not directed to two different types of particles. Thus claim 22 is directed to just the particles with the polymer.
Applicant Argument C:
Separate consideration is respectfully requested for claim 67. The Examiner acknowledges that '756 "does not expressly teach that the plurality of particles having an average particles size [is] from 200 microns to 10 mm." See OA at 8. However, the Examiner alleges Kindvall rectifies this deficiency. The Examiner alleges "Kindvall teaches an oral nicotine product comprising granules" that "have a diameter of about 0.2 mm to about 2.0 mm." See OA at 8. However, Kindvall is an entirely different product relating to coated core particle, where the entirety of the active is present in the coating. See Paragraph [0024]-[0025]. Kindvall provides no teaching or suggestion of integration of actives into the core of the particle. There is no basis, whatsoever, to contend that any particle sizes of Kindvall would be relevant to '756 granules.
In contrast, the '756 requires narrow particle size diameters to achieve its intended purpose and effect. For example, in the "in vitro dissolution test of table 3, although formula D and formula E, the particle diameter of formula F are bigger, but in vitro dissolution rate is relatively slower than formula C" and, therefore, "the nicotine immediate-release granule in the embodiment of the present invention adopts formula C." See p. 7, 4th paragraph. Similarly, for the sustained release granules, the "amount of binder used indirectly affects the release rate of nicotine, but more importantly, it affects the particle size" and the "[t]he range of particle size method, we choose Requirements are: greater than 150 mesh residue requires less than 20%." See p. 7, ninth paragraph. Therefore, less than 20% of '756's sustained release particles are retained on a 150 mesh screen (a mesh size of 89 pm as shown in Mesh to Micron Conversion Chart submitted herewith).The Examiner cannot graft the particle size properties of an unrelated granule (Kindvall) onto the '756 particles-particularly when the two types of particles function entirely differently and the '756 purpose is only achieved with a narrow particle size distribution outside of the presently claimed range. Withdrawal is warranted.
Examiner Response C:
The Examiner respectfully disagrees. While the particles within the oral pouched nicotine product of Kindvall are not exactly the same as the particles of modified ‘756, that in itself does not teach away or discourage applying the particle size to particles in another oral pouched nicotine product.
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.
Claim(s) 1, 3, 10, 66, 68 and 69 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘756 (CN112220756) in view of Mishra (US 20130340776) and further in view of Duan (US 20110083680).
A machine translation of CN112220756 is applied to translate the document. All citations to ‘756 refer to the machine translation.
Regarding claim 1, ‘756 teaches a system comprising: a) pouch (“soft bag”); and b) a plurality of particles contained within the pouch (bottom paragraph on page 5 - top paragraph on page 6); wherein, the particles comprise a core, and the core comprises an active (nicotine), a binder, a buffer, and a polymer (page 2, paragraph 8-13); wherein the nicotine is free nicotine or salts thereof (page 2, paragraph 10) and the buffer is sodium carbonate and sodium bicarbonate (page 2, paragraphs 13 and 19).
‘756 does not expressly teach that the binder is microcrystalline cellulose.
Mishra teaches a smokeless tobacco product (abstract) including a pouch holding a plurality of granules ([0012]). Mishra teaches that the core of the granules includes a binder, wherein the binder is microcrystalline cellulose (MCC) or gum Arabic or gelatin ([0021]). It would have been obvious for one of ordinary skill in the art at the time of filing to have substituted the binder, specifically gum Arabic or gelatin, in the granules of ‘756 with the binder, specifically MCC, in the granules of Mishra because it has been held that simple substitution of one known element (i.e. binder in the granules of ‘756) for another (i.e. binder in the granules of Mishra) to accomplish the same result is obvious to one of ordinary skill in the art (See MPEP 2141 and 2143).
Modified ‘756 does not expressly teach that the polymer is a low viscosity polymer that is a combination of OSA-starch and hydroxypropyl methyl cellulose (HPMC).
Duan teaches an oral pouched product containing flavor beads providing immediate and long lasting flavor release ([0002]). Duan teaches that the beads contain one polymer, specifically hydroxypropyl methyl cellulose (HPMC) ([0014]) and that the beads also contain another polymer, specifically modified starches ([0023]) such as OSA starches ([0021]). It would have been obvious to one of ordinary skill in the art at the time of filing to have applied HPMC and OSA starch as the polymers in modified ‘756 with a reasonable expectation of success and predictable results, specifically because HPMC and OSA starch both provide a smooth and creamy texture to the beads and have excellent emulsification properties ([0014] and [0023]).
Regarding claim 3, ‘756 teaches that the plurality of particles comprises a first plurality of particles and a second plurality of particles, wherein the first and second pluralities of particles have at least one characteristic distinct from one another, specifically one group of particles has nicotine immediate-release granules and another group of particles has nicotine sustained-release granules (page 1, paragraph 8).
Regarding claim 10, ‘756 teaches that the first plurality of particles and the second plurality of particles comprise the same low viscosity polymer, specifically the first plurality of particles and the second plurality of particles may have different amounts of binder (page 7, paragraph 9).
Regarding claim 66, modified ‘756 does not expressly teach that the plurality of particles have a D90 particle size greater than the minimum pore dimension.
However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have the plurality of particles have a D90 particle size greater than the minimum pore dimension to prevent the particles from leaving the pouch via the pores.
Regarding claim 68, modified ‘759 does not expressly teach that the weight ratio of OSA- starch: HPMC is from 100:1 to 2:1.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to optimize the weight ratio of OSA- starch: HPMC since it has been held that, where 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. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The burden is upon the Applicant to demonstrate that the claimed the weight ratio of OSA- starch: HPMC is critical and has unexpected results. In the present invention, one would have been motivated to optimize the weight ratio of OSA- starch: HPMC motivated by the desire to optimize the texture and emulsification properties of the beads ([0014] and [0023]).
Regarding claim 69, modified ‘756 does not expressly teach that the characteristic difference is color between the first plurality of particles and the second plurality of particles.
However, the courts have held that that matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art. See MPEP 2144.04 I. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date to have made a color difference between the first plurality of particles and the second plurality of particles with a reasonable expectation of success and predictable results, specifically to be able to visually distinguish between the first plurality of particles and the second plurality of particles.
Claim(s) 22 and 67 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of ‘756, Mishra and Duan as applied to claim 1 above, and further in view of Kindvall (US 20220248748).
Regarding claim 22, ‘756 teaches that all the particles in the plurality of particles are particles comprising:
0.55%-15% flavorants and/or sweeteners by weight;
b) 1%-20% buffer by weight;
c) 10%-90% polymer by weight
d) 1-10% nicotine by weight;
‘756 does not expressly teach that MCC is included in 30%-80% by weight.
Duan teaches an oral pouched product containing flavor beads providing immediate and long lasting flavor release ([0002]). Duan teaches that the beads contain MCC in addition to two additional polymers, specifically hydroxypropyl methyl cellulose (HPMC) ([0014]) and modified starches ([0023]) such as OSA starches ([0021]). Duan teaches that MCC is included in an amount of at least 50% by weight ([0011]). It would have been obvious for one of ordinary skill in the art at the time of filing to have included MCC in an amount of at least 50% by weight in addition to the polymers in ‘756 because MCC improves the physical strength, integrity, and processability of the beads (e.g., during preparation of beads) (Duan, [0011]).
Modified ‘756 does not expressly teach that the nicotine is part of a 3-cyclodextrin complex or polacrilex.
Kindvall teaches an oral pouched nicotine product comprising coated granules within a saliva-permeable pouch (abstract). Kindvall teaches that the nicotine active includes nicotine polacrilex ([0087]). It would have been obvious for one of ordinary skill in the art at the time of filing to have substituted the nicotine salt in ‘756 for nicotine polacrilex, as taught by Kindvall, with a reasonable expectation of success and predictable results since Kindvall teaches both nicotine salt or nicotine polacrilex can be the nicotine source in a nicotine granule ([0093]).
Regarding claim 67, modified ‘756 does not expressly teach that the plurality of particles have an average particle size of from 200 microns to 10 mm.
Kindvall teaches an oral pouched nicotine product comprising granules within a saliva-permeable pouch (abstract). Kindvall teaches that that the granules have a diameter of about 0.2 mm to about 2.0 mm ([0023]). It would have been obvious for one of ordinary skill in the art at the time of filing to have made the particles in modified ‘756 have a diameter of about 0.2 mm to about 2.0 mm, which is the diameter of the granules in Kindvall, with a reasonable expectation of success and predictable results as both are nicotine releasing particles within an oral pouched nicotine product.
Claim(s) 26 and 65 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combined teachings of ‘756, Mishra and Duan as applied to claim 1 above, and further in view of Warner (US 20080095959).
Regarding claims 26 and 65, modified ‘756 teaches that the pouch is made with a fabric used to construct tea bags (Duan, [0034]), but does not expressly teach that the warp and weave of the fabric are such that the fabric is transparent.
Warner teaches a tea bag material ([0001]-[0002]) wherein the weave pattern may be tailored such that the fabric is transparent, in that the woven fibers allow light to pass through them so that the infusion substance may be partially or fully visible through the woven fibers ([0021]). It would have been obvious for one of ordinary skill in the art at the time of filing to have adjusted the weave pattern of the fabric of modified ‘756 such that the fabric is transparent, as suggested by Warner, so that the substance inside the pouch is visible to the user.
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 YANA B KRINKER whose telephone number is (571)270-7662. The examiner can normally be reached Monday, Wednesday, Thursday and Friday.
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YANA B. KRINKER
Examiner
Art Unit 1755
/YANA B KRINKER/Examiner, Art Unit 1755 /PHILIP Y LOUIE/Supervisory Patent Examiner, Art Unit 1755