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 .
DETAILED ACTION
Continued Examination under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/10/2025 has been entered.
Status of the application
3. Claims 1, 2, 5, 7-8, 14, 20-22 and 41-51 are pending in this office action.
Claims 3-4, 6, 9-13, 15-19, 23-40 are cancelled.
Claims 42-51 are new.
Claims 1, 2, 5, 7-8, 14, 20-22, and 41-51 have been rejected.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 1, 2, 5, 7-8, 14, 20-22, and 41-51 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 14 recite “molten gum composition formed by simultaneously melting the gum base and the polyols”. However, in specification it recites gum base is heated at 60-80 degree C to make molten gum base and then mixing the molten chewing gum base with at least one polyol (in PGPUB at least in [0022], [0215], [0217], [0331], [0334], [0368]). There is support for “the gum composition is a molten gum composition comprising at least one molten gum base and at least one molten polyol” but there is no support for “molten gum composition formed by simultaneously melting the gum base and the polyols”. This renders claims 1, 14, 112 first paragraph rejection.
Claim Rejections - 35 USC § 103
6. 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 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.
7. The following is a quotation of 35 U.S.C. 103(a) that 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 of this title, 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 negatived by the manner in which the invention was made.
8. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
9. Claims 1, 2, 5, 7, 14, 20, 41, 45, 46, 47, 50, 51, are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. US 2013/0149412 in view of Ribadeau- Dumas et al. US 2004/0166197 in view of Eroma et al. US 2006/0025584.
10. Regarding claims 1, 7, and 47, Reed et al. discloses chewing gum composition having gum base, bulk sweetener, and other ingredients (at least in claims 1, 11 and 12 of Reed et al.). Reed et al. also discloses that the bulk material comprising amorphous polyols (at least in [0028]) used in such chewing gum composition ([0028]) includes sorbitol, maltitol, glycerin ({0029], [0031]). Reed also discloses that the glass transition temperature of such a material comprising sorbitol, maltitol ranges between 30-80- degree C (at least in [0042]- [0045], of Reed et al.) and keeps a consistent texture during processing steps to make chewing gum (at least in [0018], [0019]). Reed et al. also discloses that amorphous polyols in the composition provides preferred stable texture that meets the requirement for producing a chewing gum which sheets acceptably and has the first bite and general chew characteristics preferred by consumers ([0017]) and having desired glass transition temperature (at least in [0042]- [0045]) and also keep a consistent texture during processing steps to make chewing gum (at least in [0018], [(0019]).
Reed et al. is silent about the claim limitation of “wherein a weight ratio of the gum base to the bulk sweetener blend is less than about 0.6” as claimed in claim 1. Ribadeau- Dumas et al. discloses that gum base can be in an amount ranging from 10- 95% by weight in the composition ([0023]) and it depends on the type of chewing gum is to be made ([0023]) and also the preferred amount can be 20-40% by weight ([0024]).
Ribadeau- Dumas et al. also discloses in one example that the polyols can be 40 to 85% by weight ([0029]) and e.g. in one example, sorbitol and xylitol powders can be 55% by weight (Example 1). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re
Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, the ratio meets less than 0.6 as claimed in amended claim 1. It is to be noted that even if the range amounts are broad, however, the teaching that the disclosed amount of gum base (including low amount) depends on the type of chewing gum is to be made ([0023]), can be considered by one of ordinary skill in the art in order to determine the amount of gum base including the amount which will make the claimed ratio of gum base: bulk sweetener blend less than 0.6.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Reed et al. to include the teaching of Ribadeau- Dumas et al. to incorporate the amounts of gum base and polyol(s) from the disclosed range amounts as disclosed by Ribadeau- Dumas et al. ([0023], [0029]) and the ratio can be broad range including claimed 0.6 which will be considered based on the desired amount of gum base (including low amount) needed to make desired type of chewing gum needed as disclosed by Ribadeau- Dumas et al. ([0023]).
Therefore, it can be considered as result effective variable.
Absent showing of unexpected results, the specific amounts and ratio of gum base and ‘bulk sweetener blend’ is not considered to confer patentability to the claims. As the taste, texture are variables that can be modified, among others, by adjusting the amount of specific amounts of gum base (including low amount in order to have desired type of chewing gum [0023] of Ribadeau- Dumas et al.) and ratio of gum base and ‘bulk sweetener blend’, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made.
As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the specific amounts and ratio of gum base and ‘bulk sweetener blend’ in Reed et al. in view of Ribadeau- Dumas et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. taste, texture etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
It is also to be noted that Reed et al. in view of Ribadeau- Dumas et al. is silent about the claim limitation of “Wherein at least a portion of the gum base is dispersed as globular domains within a continuous amorphous phase comprising at least one of the polyols.
It is to be noted that amended claim limitation of “gum base to the bulk sweetener blend less than 0.6” has been addressed by Reed et al. in view of Ribadeau- Dumas et al. Therefore, the product claim composition of claim 1 is met by Reed et al. in view of Ribadeau- Dumas et al. It is also to be noted that at least a portion of the gum base may be in dispersed (phase) as globular domains within a continuous amorphous phase of at least one of polyols” as claimed in claim 1.
It is also evidenced from the scanning electron microscope (SEM) morphology that the dispersed phase in the crisp gum occurs when the ratio is less than 0.6 (in PGPUB [0359]) when compared to conventional soft chewing gum product (in PGPUB [0325]) as evidenced by applicants’ specification.
Regarding the claim limitation of “wherein the polyols comprise xylitol, sorbitol, and at least one isomalt and maltitol’, Reed et al. discloses that sorbitol and maltitol can be the primary polyols, however, other polyols also may be included in the bulk material ([0022)).
However, Reed et al. is specifically silent about xylitol.
Ribadeau- Dumas et al., discloses that xylitol can be included in combination with sorbitol and maltitol ([0029]).
Eroma et al. discloses that Xylitol is the sweetest polyol and is used in the confectionary composition and provides a pronounced cooling effect when it dissolves in mouth ([0010] in background but it is the property. So, it is considered as the property of Xylitol and therefore, the paragraph from Background section is has been considered).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Reed et al. in view of Ribadeau- Dumas et al. to include the teaching of Eroma et al.to consider xylitol because xylitol is the sweetest polyol which can provide desired sweetness in the confectionary composition and it also provides a pronounced cooling effect when it dissolves in mouth ([0010)).
Regarding the amended claim limitation of physical characteristics of the chewing gum composition as claimed in claim 1, it is to be noted that the three textured property are claimed using Markush group and therefore, any one is sufficient to address to meet claim 1. It is also to be noted that Reed et al. in view of Ribadeau- Dumas etal. are silent about the physical parameters of the claim limitations of these claimed inventions. However, it is to be noted that the combinations of prior arts of record meet the claim limitations of product claim 1. Therefore, as the disclosed combinations of prior arts of record meet the claimed ingredients and their amounts as claimed in claim 1, the final product would have the desired characteristics property. It is also to be noted that it is within the skill of one of ordinary skill in the art to optimize the amounts of the ingredients from the disclosed range amounts that will meet the claimed range amounts in order to have the desired characteristics claimed property of claim 1.
11. Regarding the claim limitation “ wherein the chewing gum composition is a molten gum composition formed by simultaneously melting the gum base and the polyols”, as claimed in amended claim 1, it is to be noted that Reed et al. discloses that a chewing gum composition is formed by mixing a gum base with at least one polyol containing bulk material at a temperature above the glass transition temperature of the bulk material in a temperature region in which the bulk material is in a fluid or viscous liquid state. Such bulk material will remain amorphous (i.e., will not transform into crystalline material) during or after mixing with sheer. After cooling below the glass transition temperature of the bulk material, a chewing gum formed with the bulk material will remain amorphous (at least in [0024], [0025]). Therefore, it meets “mixing simultaneously” as claimed in claim 1. It is to be noted that as because above the glass transition temperature can be interpreted as any temperature, one of ordinary skill in the art would have been motivated to consider the gum base at molten state if the melting temperature of the gum base is above the above the “glass transition temperature” of the bulk material in order to have a reasonable expectation of success to mix the components homogeneously with the gum base when gum base is also in molten condition. Therefore, it meets “wherein the chewing gum composition is a molten gum composition formed by simultaneously melting the gum base and the polyols” as claimed in claim 1.
12. Regarding texture characteristics as claimed in claim 1(i)-(iii), it is to be noted that if we consider applicants specification, it is the characteristics physical properties of the experimental inventive samples having desired crispiness, softness (in PGPUB, [0229], [0227], [0316], [0318], Figs 16A-B and Figs 14A-D) .
Regarding the amended claim limitation of physical characteristics of the chewing gum composition as claimed in claim 1, it is to be noted that the three textured property are claimed to address to meet claim 1. It is also to be noted that Reed et al. in view of Ribadeau- Dumas et al. are silent about the physical parameters of the claim limitations of these claimed inventions. However, it is to be noted that the combinations of prior arts of record meet the claim limitations of product claim 1. Therefore, as the disclosed combinations of prior arts of record meet the claimed ingredients and their amounts as claimed in claim 1, the final product would have the desired characteristics property. It is also to be noted that it is within the skill of one of ordinary skill in the art to optimize the amounts of the ingredients from the disclosed range amounts that will meet the claimed range amounts in order to have the desired characteristics claimed property of claim 1.
It is within the skill of one of ordinary skill in the art to optimize the amounts and ratio of gum base and polyols from within the disclosed range amounts which meet the claimed range amount to optimize from within less than about 0.6 (gum base: polyol) in order to have desired texture as claimed in claim 1(i)-(iii) of the final chewing gum product.
It is also to be noted that the “texture characteristics” can be addressed using Result effective variable.
Absent showing of unexpected results, the specific amounts and ratio of gum base and ‘bulk sweetener blend’ is not considered to confer patentability to the claims. As the taste, texture (i.e. Crisp) are variables that can be modified, among others, by adjusting the amount of specific amounts of gum base (including low amount in order to
have desired type of chewing gum [0023] of Ribadeau- Dumas et al.) and ratio of gum base and ‘bulk sweetener blend’, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the specific amounts and ratio of gum base and ‘bulk sweetener blend’ in Reed et al. in view of Ribadeau- Dumas et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired taste, Crisp texture etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
13. Regarding claim 2, Reed et al. in view of Ribadeau- Dumas et al., are silent about the complex shear viscosity. It is to be noted that it is known that gum base contains gum polymers and, therefore, it is within the skill of one of ordinary skill in the art to make single or combinations of polymers contributing desired viscosity which will provide the viscosity ratio 1000 as claimed in claim 2.
Absent showing of unexpected results, the specific amount of viscosity ratio is not considered to confer patentability to the claims. As the elasticity, softness of the gum are variables that can be modified, among others, by adjusting the type of polymer and also amount of total polyol and “ratio amount of polyols in the blend’, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of viscosity ratio in Kabsa et al. ‘456 to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired softness of the gum composition etc. (In re Boesch, 617 F.2d. 272, 205 USPQ215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
14. Regarding claim 5, regarding glass transition temperature, it is to be noted that the glass transition temperature of the ‘bulk sweetener blend” is a physical parameter and therefore, as the combinations of prior arts disclose the combinations of the blend of polyols, and because claim 5 is broad, therefore, it is within the skill of one of ordinary skill in the art to optimize the proportions of polyols to make the desired glass transition
of the “sweetener blend’ including presently claimed glass transition of “greater than 20-degree C. Therefore, it is result effective variable.
(Additionally), Reed et al. discloses that the chewing gum composition containing sorbitol, maltitol, glycerin ([0029], [0031]) can have glass transition temperature 30-80-degree C. Therefore, it is greater than 20-degree C of claim 5.
However, as discussed above, it is optimizable and can be addressed using Result effective variable.
Absent showing of unexpected results, the specific amount of glass transition temperature is not considered to confer patentability to the claims. As the glass transition is variable, that can be modified, among others, by adjusting the amount and type of polyols, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the type and amount of polyols, in
Kabse et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired glass transition temperature etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding crystallinity, it is to be noted that claim 5 depends on claim 1.
As discussed for claim 1 above, Eroma et al. discloses that the polyols like xylitol, maltitol etc. can be used in amorphous state ([0069)).
Also, it can be addressed as result effective variable.
Absent showing of unexpected results, the specific amount of crystallinity is not considered to confer patentability to the claims. As the type and amount of amorphous polyols present in the blend are variables that can be modified, among others, by adjusting the amount and type of individual polyols in the polyol blend, the precise amount of crystallinity would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. Therefore, the precise amount of crystallinity of the bulk sweetener blend would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the at the time the invention was made would have optimized, by routine experimentation, the amount and type of amorphous polyols in the blend in Reed et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired crystallinity etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that were the
general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
15. Regarding claim 14, Reed et al. discloses that in one embodiment, an aspect of the disclosed invention can contain 40-85% by weight of maltitol, with 5-20% by weight of sorbitol on a dry weigh basis in the ‘polyol bulk ingredient” (at least in [0093]). It is to be noted that claimed xylitol amount of 0-15 wt. % and 0-5 wt. % humectant as claimed in claim 14 can be considered as optional.
Reed et al. is silent about the ratio of gum base and bulk sweetener blend as claimed in claim 14.
It is to be noted that amended claim limitation of “gum base to the bulk sweetener blend less than 0.6” has been addressed by Reed et al. in view of Ribadeau- Dumas et
al. as discussed for claim 1 above and is applicable for claim 14 also. Therefore, the product claim composition of claim 14 is met by Reed et al. in view of Ribadeau- Dumas et al. It is also to be noted that at least a portion of the gum base gum base may be in dispersed (phase) as globular domains within a continuous amorphous phase of at least one of polyols” as claimed in claim 1.
It is also evidenced from the scanning electron microscope (SEM) morphology that the dispersed phase in the crisp gum occurs when the ratio is less than 0.6 (in PGPUB [0359]) when compared to conventional soft chewing gum product (in PGPUB [0325]) as evidenced by applicants’ specification.
The claim limitations identical to claim 1 has been addressed identically as discussed for claim 1 and is applicable for claim 14 also.
Regarding “crisp texture characteristics’ , it is within the skill of one of ordinary skill in the art to optimize the amounts and ratio of gum base and polyols from within the disclosed range amounts which meet the claimed range amount to optimize from within less than about 0.6 (gum base: polyol) in order to have desired texture as claimed in claim 1(i)-(iii) of the final chewing gum product.
It is also to be noted that the “crisp” texture can be addressed using Result effective variable.
Absent showing of unexpected results, the specific amounts and ratio of gum base and ‘bulk sweetener blend’ is not considered to confer patentability to the claims. As the taste, texture (i.e. Crisp) are variables that can be modified, among others, by adjusting the amount of specific amounts of gum base (including low amount in order to
have desired type of chewing gum [0023] of Ribadeau- Dumas et al.) and ratio of gum base and ‘bulk sweetener blend’, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the specific amounts and ratio of gum base and ‘bulk sweetener blend’ in Reed et al. in view of Ribadeau- Dumas et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired taste, Crisp texture etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Regarding texture characteristics as claimed in claim 1(i)-(iii), , it is to be noted that if we consider applicants specification, it is the characteristics physical properties of the experimental inventive samples having desired crispiness, softness (in PGPUB, [0229], [0227], [0316], [0318], Figs 16A-B and Figs 14A-D) .
Regarding the amended claim limitation of physical characteristics of the chewing gum composition as claimed in claims 1, 14, it is to be noted that that Reed et al. in view of Ribadeau- Dumas et al. are silent about the physical parameters of the claim limitations of these claimed inventions. However, it is to be noted that the combinations of prior arts of record meet the claim limitations of product claims 1, 14. Therefore, as the disclosed combinations of prior arts of record meet the claimed ingredients and their amounts as claimed in claims 1, 14, the final product would have the desired characteristics property. It is also to be noted that it is within the skill of one of ordinary skill in the art to optimize the amounts of the ingredients from the disclosed range amounts that will meet the claimed range amounts in order to have the desired characteristics claimed property of claims 1, 14.
Regarding the claim limitation of “ wherein the crisp chewing gum composition is a molten gum composition formed by simultaneously melting the gum base and the polyols at a temperature of 120° C to 160° C”, as claimed in claim 14, it is to be noted that the claim limitation “ wherein the crisp chewing gum composition is a molten gum composition formed by simultaneously melting the gum base and the polyols” addressed for claim 1 above and is applicable for claim 14 also. However, it has 112 first paragraph rejection.
Regarding the remaining claim limitation “ at a temperature of 120° C to 160° C”, it is to be noted that one of ordinary skill in the art would have been motivated to melt the gum base and polyol(s) and mix them at a reasonably higher temperature which can be higher than their melting points so they are in fluid state which will provide with a reasonable expectation of success to achieve a homogeneous mixture between them.
It is also to be noted that when the disclosed ingredients are similar to the claimed ingredients, it will have similar claimed property including the claimed temperature range which will provide homogeneous mixing between them.
It is also to be noted that the temperature is variable and depends on the type of gum base, and polyol(s) are used in this mixing process.
As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of melting temperature in Ribadeau- Dumas et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired melting temperature for homogeneous mixing (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
16. It is also to be noted that examiner notes that the amended claims 1, 14 are product-by-process claims.
The Examiner notes that these are product-by-process claims.
Therefore, it is to be noted that, in this case, the courts have held that when the prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926.
The courts also held that “even 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) (citations omitted).
Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See MPEP §2113.
Lastly the courts have held 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 myriads 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). The examiner further notes that “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). See MPEP §2113.
17. Regarding claim 20, Reed et al. in view of Ribadeau- Dumas et al. are silent about the physical parameters of the claim limitations of this claimed invention. However, it is to be noted that as because the combinations of prior arts of record meet the claim limitations of product claim 14 from which claim 20 depend on, therefore, the final product would have the desired inherent characteristics property which is “ reduction in hardness of 20 to 40% when the crisp chewing gum product is tested after the chewing gum product is chewed for 1 min” as claimed in claim 20.
18. Regarding claim 41, it is to be noted that Reed et al. in view of Ribadeau- Dumas et al. disclose that glycerin is less than 2 wt. % and any polyol e.g. maltitol can be 40-85 wt.% (at least in [0093] of Reed et al.). Therefore, it meets claim limitation of claim 41 (i). It is to be noted that the claim limitations of (i)-(vi) of claim 41 are “either”, therefore, anyone can be addressed.
19. Regarding claim 45, claim 45 depends on claim 1. It is to be noted that even if the combined teaching of Reed et al. in view of Ribadeau- Dumas et al. US in view of Eroma et al. do not mention the claim limitation of “Wherein the chewing gum composition exhibits enhanced flavor release characteristics comprising an initial flavor burst intensity at least 75% greater than a conventional chewing gum having the same flavor content”, as claimed in claim 45, however, the combinations of prior arts have disclosed all the ingredients and chewing gum composition which meet the claimed all ingredients containing chewing gum composition of product claim 1, therefore, it will have the claimed property of claim 45 including the property of “Wherein the chewing gum composition exhibits enhanced flavor release characteristics comprising an initial flavor burst intensity at least 75% greater than a conventional chewing gum having the same flavor content”.
20. Regarding claim 46, it is to be noted that and as discussed above for claim 1, it is understood from specification that the “globular domains with a continuous amorphous phase” which is evidenced by applicants specification from the scanning electron microscope (SEM) morphology that most of the continuous amorphous phases of liquid polyol and with a portion of the gum base are in dispersed globular gum base ([0359]) phase with few crystals of polyol (in specification, [0314], [0325] and [0328], [0358], [0359]).
It is to be noted that amended claim limitation of “gum base to the bulk sweetener blend less than 0.6” has been addressed by Reed et al. in view of Ribadeau- Dumas et al. as discussed for claim 1 above. Therefore, the product claim composition of claim 1 is met by Reed et al. in view of Ribadeau- Dumas et al.
It is also to be noted that at least a portion of the gum base may be in dispersed (phase) as globular domains within a continuous amorphous phase of at least one of polyols” as claimed in claim 1.
Therefore, it is the morphology which is being developed by considering that most polyols are in the amorphous state”.
Therefore, small portion of the globular domain with few crystals of polyol contributes globular domain which can be spherical because disclosed polyols are identical to the claimed polyols and therefore, having identical SEM morphology as is also evidenced by applicants’ specification (in specification, [0314], [0325] and [0328], [0358], [0359]).
21. Regarding claim 50, regarding the claim limitation “ at a temperature of 120° C to 160° C”, it is to be noted that one of ordinary skill in the art would have been motivated to melt the gum base and polyol(s) and mix them at a reasonably higher temperature which can be higher than their melting points, so they are in fluid state which will provide with a reasonable expectation of success to achieve a homogeneous mixture between them.
It is also to be noted that when the disclosed ingredients are similar to the claimed ingredients, it will have similar claimed property including the claimed temperature range which will provide homogeneous mixing between them.
It is also to be noted that the temperature is variable and depends on the type of gum base, and polyol(s) are used in this mixing process.
As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of melting temperature in Ribadeau- Dumas et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired melting temperature for homogeneous mixing (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
22. Regarding claim 51, it is to be noted that Reed et al. discloses that the disclosed chewing gum product has chew characteristics by consumers ([0017]). Therefore, it can be soft chewing gum. Therefore, the disclosed chew characteristics chewing gum ([0017] of Reed et al.) is soft gum and will avoid needles as evidenced from applicants’ specification (In PGPUB [0314]). It is also within the skill of one of ordinary skill in the art to evaluate the disclosed soft chewy chewing gum ([0017] ) of Reed et al. which avoid needles as can be confirmed by scanning electron microscopy(SEM) as evidenced from applicants’ specification that “Soft gum also does not have needle-shape crystals present in the conventional gum (In PGPUB [0314]).
36. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. US 2013/0149412 in view of Ribadeau- Dumas et al. US 2004/0166197 in view of Eroma et al. US 2006/0025584 as applied to claim 1 and further in view of Kabse et al. USPN 2006/0051456 A1 as evidence given by NPL plasticizer.
37. Regarding claim 8, Reed et al. discloses that no more than 2 wt.% glycerin is added to the “bulk material’ (at least in claim 1 of Reed et al.). Ribadeau- Dumas et al. discloses that glycerol (i.e. glycerin) is used in order to serve as plasticizer ([O030]). Therefore, it meets “further comprising between 0.1 to 1% by weight of plasticizer as claimed in claim 1.
It is also to be noted that the partition coefficient and molecular weight of a plasticizer is the physical property.
Kabse et al. ‘456 discloses that softeners (i.e. plasticizers) e.g. glyceryl monostearate serves as plasticizer because of its low molecular weight which allows to penetrate the fundamental structure of the gum base in order to plasticize and soften the gum base of the chewing gum composition ([0082]). It is known and as evidenced by NPL Plasticizer that glyceryl monostearate has molecular weight 358 g/mole (page 1). Therefore, one of ordinary skill in the art can include the softeners/plasticizers from the disclosed list of the plasticizer ingredients of Kabse et al.’456 that will have desired low molecular weight 358 g/mole as evidenced by NPL Plasticizer (page 1) which is less than 1000 g/mole which will have an inherent partition coefficient of at least 2 and having a desired inherent property of highly compatible to gum base as evidenced by applicants’ own specification ([0244] of PGPUB).
38. Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. US 2013/0149412 in view of Ribadeau- Dumas et al. US 2004/0166197 in view of Eroma et al. US 2006/0025584 as applied to claim 14 and further in view of Kramer F et al. USPN 2886441.
39. Regarding claim 21, Reed et al. in view of Ribadeau- Dumas et al. disclose that the composition contains flavoring material (at least in Abstract, [0016], [0019] of Reeed et al.). that can be used in chewing gum composition and can be tailored to provide specific release characteristics ([0040)).
However, they are silent specifically about claim limitation of claim 21.
Kramer F et al. discloses that the flavoring agent containing chewing gum composition can be made such a way so that it can perform as controlled release flavor (with plurality of bursts including initial burst (col 1 lines 31 -33 and in col 4 lines 20- 30).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Reed et al. in view of Ribadeau- Dumas et al. by including the teaching of Kramer et al. to make controlled release flavor profiles containing chewing gum composition in order to have prolonged release of flavor with intermittent plurality of burst profiles property so that the perception of flavor will not disappear within a short time period (col 1 lines 15-20 and col 1 lines 30-35).
It is also to be noted that claims 1, (addressed above), 9 (Tested), 17 (Tested) are considered as product-by-process claims.
Therefore, it is to be noted that, in this case, the courts have held that when the prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicant to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted, “No objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d at 1926. The courts also held that “even 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) (citations omitted). Lastly the courts have held 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 myriads 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). The examiner further notes that 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).
40. Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. US 2013/0149412 in view of Ribadeau- Dumas et al. US 2004/0166197 in view of Eroma et al. US 2006/0025584 as applied to claim 14 and in view of Dautun et al. WO 2013/192066 and further in view of NPL Isomalt (First two pages of McNutt et al. 2003; posted as NPL 10/28/2020).
41. Regarding claim 22, claim 22 depends on claim 14 based on the claim limitation of isomalt plus maltitol of claim 14. In this respect, Reed et al. discloses that other polyols may be included in the bulk material ([0022] of Reed et al.). Ribadeau- Dumas et al. discloses that isomalt , as polyol, can be included in chewing gum composition ([0029]).
Reed et al. in view of Ribadeau- Dumas et al. are silent about the claimed ratio of claim 22.
Reed et al. discloses that sorbitol can be used as primary polyol instead of maltitol ([0020]) and it can be at least about 60 wt.% sorbitol and at least about 15 wt.% maltitol ([0022]).
Dautun et al. discloses that ([0015]) a chewing gum product, can contain polyol(s) in an amount of about 40 to about 80 weight percent based on the total chewing gum product ([0015], [0025]) which includes isomalt in an amount ranging from about 15 to about 35 weight percent isomalt in chewing gum composition ([0025]).
Therefore, if we consider “about 15 wt.% of maltitol” of Reed et al. ([0022], [0066]) and about 35 weight percent isomalt in chewing gum composition of Dautun et al. ([0025]), the ratio is 15/35=0.42 to meet claim 22.
NPL Isomalt discloses that isomalt has less sweetening power with similar sweetening property (page 1) and with no water absorbing (non -hygroscopic) (page 2, second paragraph) and isomalt offers benefits that fit health-oriented lifestyles,
contemporary weight management guidelines, and the functional foods or nutraceuticals product category (page 1 first paragraph).
One of ordinary skill in the art before the effective filling date of the claimed invention can modify polyol blend of Reed et al. in view of Ribadeau- Dumas et al. to include the teaching of Dautun et al. to consider the amount of isomalt from the disclosed range amount of isomalt ([0025] of Dautun) as mentioned above in order to have desired sweetness and less hygroscopic composition as isomalt is low-hygroscopic less sweet polyol as disclosed by NPL Isomalt (pages 1,2 of McNutt Under Isomallt).
In addition, the ratio of claim 22 can be addressed using Result effective variable as discussed below.
Regarding the claim 22, it is also to be noted that the different range amounts and the ratio of respective polyols in the “bulk sweetener blend’ is considered as Result effective variable.
Absent showing of unexpected results, the specific amount of polyol is not considered to confer patentability to the claims. As the sweet taste, solubility, texture are variables that can be modified, among others, by adjusting the amount of polyols, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of polyols in Reed et al. in view of Ribadeau- Dumas et al. to amounts and ratio, including that presently respective claims as claimed, in order to obtain the desired effect e.g. desired sweet taste, texture etc. (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
42. Claims 42, 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. US 2013/0149412 in view of Ribadeau- Dumas et al. US 2004/0166197 in view of Eroma et al. US 2006/0025584 as applied to claim 1 and in view of Dautun et al. WO 2013/192066 and further in view of NPL Isomalt (on pages 1-2, McNutt et al. 2003; posted as NPL 10/28/2020).
43. Regarding claim 42, Reed et al. discloses the limited small amount of glycerin ([0019]) is present e.g. about 0.2 wt.% ([0031]) in order to serve as a humectant ([0031]) in such a chewing gum composition.
Ribadeau- Dumas et al. discloses that isomalt can be included with other polyols in chewing gum composition ([0029]).
Reed et al. in view of Ribadeau- Dumas et al. are silent about the claimed ratio of claim 22.
Dautun et al. discloses that ([0015]) a chewing gum product, can contain polyol(s) in an amount of about 40 to about 80 weight percent based on the total chewing gum product ([0015], [0025]) which includes isomalt in an amount ranging from about 15 to about 35 weight percent isomalt in chewing gum composition ([0025]).
NPL Isomalt discloses that isomalt has less sweetening power with similar sweetening property (page 1) and with no water absorbing (non -hygroscopic) (at least page 2, second paragraph) and isomalt offers benefits that fit health-oriented lifestyles, contemporary weight management guidelines, and the functional foods or nutraceuticals product category (page 1 first paragraph).
Therefore, if we consider glycerin is present e.g. about 0.2 wt.% in the composition as disclosed by Reed et al. ([0019], [0031]) and if we combine the teaching of Dautun et al. isomalt in an amount ranging from about 15 to about 35 weight percent isomalt ([0025]), then the ratio meets the claimed ratio of less than 0.09 as claimed in claim 42.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Reed et al. in view of Ribadeau- Dumas et al. to include the teaching of Dautun et al. to include an amount ranging from about 15 to about 35 weight percent isomalt ([0025]), in the chewing gum composition because isomalt has less sweetening power with similar sweetening property (page 1) and it offers benefits that fit health-oriented lifestyles, contemporary weight management guidelines, and the functional foods or nutraceuticals product category as disclosed by NPL Isomalt (page 1 first paragraph).
44. Regarding claim 43, Reed et al. discloses that maltitol can be used as primary polyol instead of sorbitol ([0020]) and it can be at least about 70 wt.% maltitol and at least about 5 wt.% sorbitol ([0022]). Ribadeau- Dumas et al. discloses Ribadeau- Dumas et al. discloses that isomalt can be included with other polyols, in chewing gum composition ([0029]).
Dautun et al. discloses that ([0015]) a chewing gum product, ca