Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant's arguments filed 7/02/2026 have been fully considered but they are not persuasive.
Applicant’s arguments concern claim amendments that are addressed in the rejections below.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 21, 22, 25-32, 34, 35, and 38-40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over McClements (US 2007/0082094), in view of Casey III, et al. (US 5,396,911 A), Hind et al. (US 3,435,829, incorporated by reference by Casey III, et al.) and in view of evidence from Burhan et al. (Rheological Assessments on Alginate and Carrageenan as Nanoparticle Carriers for Topical Oral Cancer Drug, 2023).
Regarding claims 21, 25, 31, 33, 34, and 38, McClements discloses that food particulate component (i.e. plant material such as vegetable pieces, herbs, spices, nuts and grains, 0016) can be contacted with a protein (casein, whey, soy, egg, gelatin protein) at a pH below its isoelectric point to form a cationic or net positively charged coating or film. A second layer is formed with an anionic or net negatively-charged polysaccharide (including pectin, which is anionic, but also carrageenan, alginate, gum Arabic) coating that attaches to the protein through electrostatic interaction (0015).
McClements further states that polysaccharides can include pectin, chitosan, starch, agar, modified starch, cellulose, modified cellulose, gum arabic, alginates, guar gum, xanthan gums, carrageenans, agars, seed gums, tree gum exudates, gellan gum and combinations thereof [0019] and [0037]. Example 1 [0044] discloses using a mixture of two polysaccharides, agar and carrageenan. It would have been obvious to one of ordinary skill in the art at the time of invention to use a combination of any of the disclosed polysaccharides as expressly disclosed by McClements, including pectin and agar.
McClements does not teach that plant pectin is sourced from tobacco or is unwashed or undialyzed tobacco pectin, however, the steps and parameters for the process for sourcing the plant pectin do not add patentable details to this invention, as no structural characteristics are association with the step in the specification. As such, this is a “product by process” claim,
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113).
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) …
"[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Alternatively, it is well known in the art that tobacco is a source of usable pectin and to use this pectin in conjunction with other polysaccharides. Casey, III et al. disclose using naturally occurring in tobacco alone or in admixture with other binders such as alginates, starches, guar gum, carrageenan, locust bean gum, and xanthan gum (i.e. also polysaccharides, (col. 11, 37—col. 12, 4). It would have been obvious to one of ordinary skill in the art at the time of invention/filing to use pectin from tobacco as disclosed by Casey, III et al. along with other polysaccharides in the invention of McClements. Replacing one pectin with another for a different source would have achieved predictable results in light of the disclosures McClements and Casey, III.
Further motivation for using tobacco pectins in place of some of the other polysaccharides is provided by Hind et al. (incorporated by reference by Casey, III). Hind et al. disclose that bonding with tobacco pectins allows the pectin to be used without purification because any contaminants present are closely related tot eh materials that are normally present in tobacco, “and thus, do not add any undesired qualities to the tobacco”.
McClements discloses that, “The pH can be varied to change the net electrical charge of the substrate or coating sufficient to promote electrostatic interaction…” [0015]. In particular, McClements discloses that pH can be adjusted below the isoelectric point. This inherently indicates that the coatings can be changed from anionic, to neutral (isoelectric point), and then cationic. It would have been obvious to one of ordinary skill in the art at the time of invention that the coated particle could be made negatively charged, neutral, or positively charged by changing the pH as disclosed by McClements.
In addition, the process and ingredients disclosed by McClements are the same as those which are disclosed by the instant specification which are disclosed as resulting in a net negatively charged particle [0029, 0033, 0040, 0046, 0056, 0069, and 0073]. Because the process and ingredients are the same as those which are disclosed in the specification, the results are inherently the same as those which are claimed.
Although McClements expressly discloses the relationship between charge and pH for proteins and polysaccharides, McClements does not expressly disclose that the zeta potential of the coated particle is between about -5 to -60 mV. However, Burhan et al. disclose that the zeta potential vs. pH for kappa-carrageenan, iota-carrageenan, and alginate. In pH from 4-10, the zeta potential for all three were between -5 and -40 mV. It would have been inherent that the particles coated with alginate or carrageenan of McClements would have had zeta potentials between -5 and -40 mV at pH from 4-10. Alternatively, it would have been obvious to one of ordinary skill in the art at the time of invention to use pH as taught by McClements to make the polysaccharide have a negative charge (i.e. zeta-potential) as taught by McClements to coat the positively charged protein layer. This would inherently make the particle negative because it is coated with a negatively charged polysaccharide. It would have been obvious to one of ordinary skill in the art to use pH to produce known negative zeta potentials as disclosed by Burhan et al. Please note, Burhan et al. is not prior art. The disclosure of Burhan et al. regards the inherent properties of polysaccharides.
Regarding claim 22, the plant materials of McClements are capable of being use as tobacco substitutes and include some of the same parts of plants as disclosed in the instant specification [0027].
Regarding claims 28 and 29, McClements discloses that the polymeric components of the layers are selected based on a variety of parameters including salt concentration [0033]. It would have been inherent that salt would have been present and part of the coating because salt would have been present in the components.
Regarding claim 30, McClements does not disclose the color of the finished particle vs the starting plant material. However, the prior art would inherently result in the same color properties because the same materials and process are disclosed.
Regarding claims 32, McClements does not teach that plant protein is sourced from tobacco, however, the steps and parameters for the process for sourcing the plant protein do not add patentable details to this invention, as no structural characteristics are associated with the step in the specification. As such, this is a “product by process” claim.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), (MPEP 2113).
"The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature" than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983) …
"[T]he lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972).
Regarding claim 26, McClements discloses that a third layer can be formed on top of the 2nd layer and is formed of one of the biopolymers, which include carrageenans [0031].
McClements does not expressly disclose which carrageenan is used by expressly discloses that, “carrageenans” can be used (i.e. plural form of the word carrageenan). It is well known in the art that there are three types of carrageenans, one of which is kappa carrageenan. It would have been obvious to one of ordinary skill in the art at the time of invention that the use of the term “carrageenans” by McClements intended to encompass all three types of carrageenans individually. Therefore, it would have been obvious to one of ordinary skill in the art to use kappa carrageenan as the polysaccharide in the invention.
Regarding claim 35, see claim 26 above concerning kappa carrageenan.
Regarding claim 27, McClements et al. do not expressly disclose kappa carrageenan that is 10-60% of the total polysaccharide in the 1st and 2nd layers or tobacco pectin and kappa carrageenan as the polysaccharide composition. However, McClements discloses that a combination of biopolymers (proteins and polysaccharides) and that the combination may be optimized by using a combination of components. For example, McClements discloses that, “protein components can be selected on the basis of their amino acid residues to optimize overall net charge, interaction with an emulsifier component and/or resultant coating stability,” (0019). It would have obvious to one of ordinary skill in the art at the time of invention to use a combination of polysaccharides such as carrageenan and pectin to optimize overall net charge, interaction with an emulsifier component, and the resultant coating stability. In particular, the range claimed (10-60%) encompasses the simplest combination of two components (i.e. 50/50) and therefore would have been obvious to try in a combination as taught by McClements.
Regarding claim 39, McClements does not expressly disclose the moisture content of the particles. However, it would have been obvious to one of ordinary skill in the art at the time of invention that the moisture content of the particle would equalize with the surrounding environment. Therefore, 2-6 % moisture would occur in many normal, temperate climates.
Regarding claim 40, McClements does not disclose adding salt to the coatings.
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 MICHAEL J FELTON whose telephone number is (571)272-4805. The examiner can normally be reached on Monday, Thursday-Friday 7:00-4:30, Wednesday 7:00-1:00.
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/Michael J Felton/Primary Examiner, Art Unit 1747
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