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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/09/2025 has been entered.
Claims 4-9, 11, and 16-19 are cancelled.
Claims 1-3, 10, 12-15, and 20-32 are under current examination.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Interpretation
For purposes of examination and applying prior art, the term “about” is being interpreted as defined in the specification at paragraph [0025], “It should also be appreciated that the term "about," as used herein, in conjunction with a numeral refers to a value that may be ± 0.01 % (inclusive), ± 0.1 % (inclusive), ± 0.5% (inclusive), ± 1 % (inclusive) of that numeral, ± 2% (inclusive) of that numeral, ± 3% (inclusive) of that numeral, ± 5% (inclusive) of that numeral, ± 10% (inclusive) of that numeral, or ± 15% (inclusive) of that numeral.” That is, numerals modified by the term “about” are interpreted as being inclusive of the numeral ± 15%.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 10, 12-15, and 20-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
In accordance with MPEP § 2106, claims found to recite statutory subject matter (in the instant
case, a composition of matter; Step 1: YES) are then analyzed to determine if the claims recite any
concepts that equate to an abstract idea, law of nature, or natural phenomenon (Step 2A, Prong One). In
the instant application, the claims are directed to:
An oral care composition, comprising:
an orally acceptable vehicle;
wherein the orally acceptable vehicle comprises a source of zinc ion present in an amount of from about 0.01 wt% to about 5 wt% based on the total weight of the composition
one or more fructans; and
one or more thickening agents, wherein the thickening agents are present in an amount effective to prevent crystallization of the one or more fructans in the orally acceptable vehicle upon exposure to an accelerated aging condition, said condition comprising exposure to temperatures at about 0°C or less, and wherein the weight ratio of the fructans to the thickening agents is from about 0.1: 1 to about 10: 1.
The claims further recite that the one or more fructans comprise inulin wherein the inulin comprises a degree of polymerization of from 2 to less than 10, the one or more thickening agents comprises xanthan gum, and the orally acceptable vehicle comprises one or more of a humectant, a solvent, a pH modifying agent, a fluoride ion source, a desensitizing agent, a flavorant, or combinations thereof wherein the humectant comprises one or more of xylitol, glycerin, sorbitol, trimethylene glycol, or a combination thereof and wherein the flavorant comprises menthol.
The claims are directed to a judicial exception such as a natural phenomenon (e.g., product of nature) as the only compositional requirement set forth in the instant claims is that the composition comprises a combination of naturally occurring ingredients.
As evidenced by Cosmetic Ingredient Review (“Safety Assessment of Zinc Salts as Used in Cosmetics”), zinc salts (a source of zinc ions) occur naturally in some seafood, red meat, whole grains, and human tissues and body fluids (pg. 4, “Natural Occurrence”); zinc salts are used in oral care products (pg. 4, bottom paragraph).
As evidenced by Chen et al. (“Effects of inulin with different polymerization degrees on the structural and gelation properties of potato protein”; of record), inulin is a natural fructan joined by β (2→1) glycosidic bonds with a terminal β-glucose unit; the degree of polymerization of inulin varies from 2 to 60 depending on the plant source and isolation or production methods (pg. 1, “Introduction”, paragraph 3).
As evidenced by Villines (“All you need to know about xanthan gum”; of record), xanthan gum is a polysaccharide, a type of sugar that is made from a bacteria called Xanthomonas campestris (pg. 1, paragraph 2).
As evidenced by WebMD (“Xylitol-Uses, Side Effects, and More”; of record), xylitol is a natural sugar alcohol found in plants (“Overview”, paragraph 1).
As evidenced by American Lung Association (“What Is Menthol?”; of record), menthol is a chemical naturally found in peppermint and other mint plants (pg. 1, paragraph 1).
In view of the above, all of the components recited in instant claims 1-3, 10, 12-15, and 20-32 are naturally occurring.
MPEP 2106.04(c) states that the markedly different characteristics analysis is part of Step 2A Prong One: “Where the claim is to a nature-based product produced by combining multiple components (e.g., a claim to "a probiotic composition comprising a mixture of Lactobacillus and milk"), the markedly different characteristics analysis should be applied to the resultant nature-based combination, rather than its component parts.” Further, from MPEP 2106.04(c): “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.”
The guidelines for performing the markedly different characteristics analysis, include (a) selecting the appropriate naturally occurring counterpart(s) to the nature-based product limitation, (b) identifying appropriate characteristics for analysis, and (c) evaluating characteristics to determine whether they are "markedly different".
Regarding (a), MPEP 2106.04(c) recites: “When the nature-based product is a combination produced from multiple components, the closest counterpart may be the individual nature-based components of the combination. For example, assume that applicant claims an inoculant comprising a mixture of bacteria from different species, e.g., some bacteria of species E and some bacteria of species F. Because there is no counterpart mixture in nature, the closest counterparts to the claimed mixture are the individual components of the mixture, i.e., each naturally occurring species by itself. See, e.g., Funk Bros., 333 U.S. at 130, 76 USPQ at 281 (comparing claimed mixture of bacterial species to each species as it occurs in nature); Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (although claimed as a pair, individual primer molecules were compared to corresponding segments of naturally occurring gene sequence); In re Bhagat, 726 Fed. Appx. 772, 778-79 (Fed. Cir. 2018) (non-precedential) (comparing claimed mixture of lipids with particular lipid profile to "naturally occurring lipid profiles of walnut oil and olive oil").”
In the instant case, the closest counterparts to the claimed mixture are the individual components of the mixture.
Regarding (b), MPEP 2106.04(c) recites: “Appropriate characteristics must be possessed by the claimed product, because it is the claim that must define the invention to be patented. Cf. Roslin, 750 F.3d at 1338, 110 USPQ2d at 1673 (unclaimed characteristics could not contribute to eligibility). Examiners can identify the characteristics possessed by the claimed product by looking at what is recited in the claim language and encompassed within the broadest reasonable interpretation of the nature-based product. In some claims, a characteristic may be explicitly recited.”
In the instant case, the claims are directed to an oral care composition with the characteristic that the one or more thickening agents are effective to prevent crystallization of the one or more fructans in the orally acceptable vehicle upon exposure to temperatures at about 0 °C or less (see instant claim 1) and exposure to a temperature of about -10 °C (see instant claim 32). The claims further recite the characteristic that the one or more fructans are effective to treat or prevent oral malodor (see instant claim 21), and the one or more thickening agents are effective to modify the viscosity of the composition (see instant claim 23).
Regarding (c), MPEP 2106.04(c)recites: “The final step in the markedly different characteristics analysis is to compare the characteristics of the claimed nature-based product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart.
If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.”
As evidenced by Villines, xanthan gum serves a primary purpose as a thickening agent (pg. 5, “What is xanthan gum used for?”), indicating that xanthan gum is capable of modifying the viscosity of a composition.
As evidenced by Deosen (“Application of Water Solubility of Xanthan Gum in Food Processing”; of record), xanthan gum has good stability to temperature (see pg. 1, second paragraph from bottom), can act as a stabilizing emulsifier in the range of -18~100 °C, can control the growth rate of ice crystals, and can inhibit the increase of ice crystals (see pg. 2, “2. Application of xanthan gum in frozen foods”), indicating that xanthan gum is capable of preventing crystallization upon exposure to temperatures of 0 °C or less and exposure to a temperature of about -10 °C.
As evidenced by Doran et al. (“A clinical study on the effect of the prebiotic inulin in the control of oral malodour”; of record), after rinsing with inulin, a reduction in tongue pH concomitant with a reduction of breath odor was observed (pg. 161, “Discussion” paragraph 1), indicating that inulin is capable of treating oral malodor.
As such, there is no indication of record that the components of the claimed composition have been structurally or functionally changed from their naturally occurring counterparts or that their combination has imparted a markedly different characteristic to the composition.
Consequently, the claimed composition lacks markedly different characteristics and is a product
of nature exception (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2).
This judicial exception is not integrated into a practical application because there are no additional structural elements recited in the claims beyond the judicial exception.
From MPEP 2106.04(d): “Because a judicial exception alone is not eligible subject matter, if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application.” (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B).
The claims do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from merely reciting a composition containing all naturally occurring components, the composition having properties that are consistent with the naturally occurring counterparts of the components of the composition.
The recitation of specific amounts and ratios of ingredients does not appear to add significantly more. There is no evidence that suggests that the properties claimed would not be achieved by simply combining the claimed components. Merely adjusting the amounts and ratios of components would not rise to substantially more than the judicial exception (Step 2B: NO).
Therefore, the claims are not patent eligible subject matter under 35 USC § 101.
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-3, 10, 12-15, and 20-32 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites the limitations "the fructans" in line 9 and “the thickening agents” in lines 9-10. There is insufficient antecedent basis for these limitations in the claim, as the claim previously recites “one or more fructans” and “one or more thickening agents”, respectively. It is unclear if the claim requires the presence of multiple fructans and multiple thickening agents or not. It is suggested that Applicant can recite, “the weight ratio of the one or more fructans to the one or more thickening agents is…” in lines 9-10.
Claims 2-3, 10, 12-15, and 20-32 are rejected under 35 U.S.C. 112(b) by virtue of their dependency on indefinite claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 10, 12-15 and 21-32 are rejected under 35 U.S.C. 103 as being unpatentable over Schapiro et al. (US 9,387969 B2, patent issued July 12, 2016, included in IDS submitted 11/22/2022), hereafter “Schapiro” as evidenced by Deosen (“Application of Water Solubility of Xanthan Gum in Food Processing” May 12, 2021, https://web.archive.org/web/20210512120120/https://www.deosen.com/application-of-water-solubility-of-xanthan-gum-in-food-processing.html; of record) in view of Doran et al. (“A clinical study on the effect of the prebiotic inulin in the control of oral malodour” Microbial Ecology in Health and Disease, 2007, 19, 158-163; of record), hereafter “Doran”, Tom’s of Maine (“Spearmint Natural Prebiotic Fluoride Toothpaste”, March 2020, Mintel Database GNPDAN:7501575; included in IDS submitted 06/06/2023), and Rege et al. (US 2015/0313813 A1, published November 5th, 2015), hereafter “Rege”.
Regarding instant claim 1, Shapiro teaches a toothpaste composition including different combinations of ingredients including one or more fructans (specifically inulin) and one or more thickening agents (konjac gum and/or agar-agar, xanthan, tara gum, gum Arabic, etc.) combined in an orally acceptable vehicle (water) (abstract, examples 2 and 3). The specification of the instant invention states that "the thickening agents may be present in an amount effective to stabilize or facilitate the stabilization of the one or more fructans, preferably, the thickening agents may be present in an amount effective to stabilize or facilitate the stabilization of the one or more fructans upon exposure to an accelerated aging condition, more preferably, the accelerated aging condition may include exposure to temperatures at about 0°C or less. In at least one implementation, the thickening agents may be present in an amount of from about 0.1 wt% to about 10 wt%" (paragraphs [0013]-[0014]). As further noted in the instant specification, thickening agents prevent formation of crystallization of inulin (paragraph [0028]). This wt.% of thickening agents present is therefore interpreted to be an amount effective to stabilize or facilitate the stabilization of the one or more fructans.
Schapiro provides, in alternative example 2, an example where inulin is present from 0.2-0.7 wt.% and a combination of konjac gum and the thickeners xanthan/guar are present from 1.15-4.55 wt.%; this falls within the range cited in the instant specification as an amount effective to stabilize or facilitate the stabilization of the one or more fructans upon exposure to an accelerated aging conditions including exposure to temperatures at about 0°C or less. This further provides a range of weight ratios of fructan to thickening agent from 0.04:1 to 0.6:1, overlapping the range of instant claim 1. From MPEP 2144.05: “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).”
Given that Schapiro teaches xanthan/guar and konjac gum thickeners from 1.15-4.55% with inulin, the thickeners would necessarily prevent crystallization of inulin upon exposure to an accelerated aging condition comprising exposure to temperatures at about 0°C or less, absent evidence to the contrary. Further, as evidenced by Deosen, xanthan gum has good stability to temperature (see pg. 1, second paragraph from bottom), can act as a stabilizing emulsifier in the range of -18~100 °C, can control the growth rate of ice crystals, and can inhibit the increase of ice crystals (see pg. 2, “2. Application of xanthan gum in frozen foods”), indicating to one of ordinary skill in the art that xanthan gum is capable of preventing crystallization upon exposure to temperatures of 0 °C or less.
Regarding instant claim 2, as described above, the toothpaste composition of Schapiro in examples 2 and 3 can comprise inulin.
Regarding instant claim 10, the specification of the instant invention states that "the fructans and the thickening agents may be present in a weight ratio sufficient to stabilize or facilitate the stabilization of the fructans. In at least one implementation, the weight ratio of the fructans to the thickening agents may be from about 0.1: 1 to about 10: 1..." (paragraphs [0015]-[0016]); this range of weight ratios is therefore interpreted to be sufficient to stabilize or facilitate the stabilization of the fructans. As noted above, Schapiro provides, in alternative example 2, an example where inulin is present from 0.2-0.7 wt.% and a combination of konjac gum and xanthan/guar are present from 1.15-4.55 wt.%; this provides a range of weight ratios of fructan to thickening agent from 0.04:1 to 0.6:1, overlapping the range of instant claim 1. From MPEP 2144.05: “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).”
Regarding claims 12-13, the composition of Schapiro further comprises the humectant of xylitol (examples 1-3). Schapiro further teaches that the flavor of the compositions may be altered by the addition of natural and/or artificial flavorants (column 5, lines 50-53).
Regarding claim 15, Schapiro further provides a method of making the toothpaste compositions described above; notably, column 4, step 5 describes mixing (contacting) the components of example 2. As inulin is provided as an alternative to tara gum in this example, the active method step of claim 15 is suggested. Contacting the components would necessarily result in the property of preventing, inhibiting, or mitigating crystallization of the fructan, absent evidence to the contrary.
Regarding instant claims 21-22, the specification of the instant invention states that "the one or more fructans may be present in an amount effective to treat, prevent, or otherwise inhibit oral malodor. For example, the one or more fructans may be present in an amount from about 0.01 wt.% to about 10 wt.% ... " (paragraph [0035]); this wt.% of fructans present is therefore interpreted to be an amount effective to treat, prevent, or otherwise inhibit oral malodor. Schapiro provides in alternative example 2 a composition that comprises 0.2-0.7% inulin by weight, overlapping the range of instant claim 22. From MPEP 2144.05: “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).”
Regarding instant claim 23, the composition of Schapiro is directed to a toothpaste product comprising different combinations of ingredients including one or more polymer thickening agents (konjac gum and/or agar-agar, xanthan, tara gum, gum Arabic, etc.) that maintains its shape (abstract); thus, the viscosity of the toothpaste has been modified, and the thickening agents are considered to be in an amount present to modify the viscosity.
Regarding instant claims 24-27 Schapiro teaches that the toothpaste composition "includes different combinations of konjac gum and/or agar-agar, alginates, gelatin, pectin, xanthan, tara gum, gum arabic, carrageenan, celluloses, gellan gum, guar gum, inulin, konjac, locust bean gum, pectin, tragacanth, xanthan ... "(abstract). Examples 2 and 3 comprise the polysaccharide gum xanthan.
Regarding instant claims 28-29, Schapiro provides, in alternative example 2, an example where inulin is present from 0.2-0.7 wt.% and a combination of konjac gum and xanthan/guar are present from 1.15-4.55 wt.%, overlapping the claimed ranges. From MPEP 2144.05: “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).”
Regarding instant claim 30, Schapiro teaches that tara gum can be present in the composition from 0.1 to 0.5% by weight in the toothpaste composition (Example 1), and further suggests that inulin can act as an alternative ingredient to tara gum in such compositions (Examples 2 and 3). From these teachings, it would have been prima facie obvious to one of ordinary skill in the art that amounts of inulin from 0.1 to 0.5% by weight are suitable for use in the toothpaste compositions of Schapiro, overlapping the range of the instant claim. From MPEP 2144.05: “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).”
Regarding instant claim 31, Schapiro teaches water present from 41-54% by weight in the compositions (Examples 1-3). This overlaps the recited range of water (about 60 wt% being inclusive of 60 wt% ± 15%, or 51-69 wt%). From MPEP 2144.05: “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).”
Regarding instant claim 32, as noted above, Schapiro provides, in alternative example 2, an example where inulin is present from 0.2-0.7 wt.% and a combination of konjac gum and the thickeners xanthan/guar are present from 1.15-4.55 wt.%; this falls within the range cited in the instant specification as an amount effective to stabilize or facilitate the stabilization of the one or more fructans upon exposure to an accelerated aging conditions including exposure to temperatures at about 0°C or less (which is inclusive of temperatures of about -10 °C). Additionally, as evidenced by Deosen, xanthan gum has good stability to temperature (see pg. 1, second paragraph from bottom), can act as a stabilizing emulsifier in the range of -18~100 °C, can control the growth rate of ice crystals, and can inhibit the increase of ice crystals (see pg. 2, “2. Application of xanthan gum in frozen foods”).
While inulin is provided as an alternative to tara gum in the examples of Schapiro, Schapiro does not specifically exemplify a composition comprising inulin or the active method step of contacting inulin with the orally acceptable vehicle and the thickening agents. Schapiro does not teach that the oral care composition comprises a source of a zinc ion present in an amount of from about 0.01 wt% to about 5 wt% based on the total weight of the composition. Schapiro does not teach the limitation of instant claim 14 that the flavorant comprises menthol.
Doran teaches that oral care rinses comprising the prebiotic inulin may provide a method for the control of oral malodour (Abstract), particularly through the ecological control of microorganisms in the mouth (Introduction) and maintaining the natural balance of the oral microflora (pg. 162, column 2, paragraph 4). Doran teaches that after rinsing with inulin, a reduction in tongue pH concomitant with a reduction of breath odor was observed (pg. 161, “Discussion” paragraph 1).
Tom’s of Maine teaches a commercial prebiotic toothpaste that comprises inulin, the thickeners of xanthan gum and carrageenan, and zinc citrate (pg. 2, “Ingredients”) which is taught to help support good bacteria and maintain a healthy balance and freshen breath (pg. 1, “Product Description”).
Rege teaches oral care compositions comprising from about 0.05 to about 5% by weight of a zinc ion source (abstract, claim 1) wherein the zinc ion source is zinc citrate (claims 2 and 12; paragraph [0011]). The compositions can comprise a viscosity modifying agent such as xanthan gum (see paragraph [0023] and Examples in Table 1 at paragraph [0084]). Rege teaches that zinc has been shown to have antibacterial properties in plaque and caries studies, and zinc salts have been used in dentifrice compositions (paragraphs [0001]-[0004]); the compositions of Rege are taught to comprise a zinc ion source that provides an amount of zinc effective to inhibit erosion (paragraph [0011]). Rege teaches that the oral care composition can be a toothpaste (paragraph [0048]). Rege teaches that the oral care compositions may include a flavoring agent such as menthol (paragraph [0071]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to substitute the inulin taught by Schapiro for tara gum in the example composition and method of Schapiro. As inulin is expressly stated as a suitable alternative to tara gum in the composition of Schapiro, one of ordinary skill in the art would consider it to have an equivalent effect in the composition. Further, as suggested by Doran, inclusion of inulin in oral care products can be used to maintain a balance of the oral microflora and a reduction of breath odor; as further suggested by Tom’s of Maine, inulin can be used in combination with thickeners in prebiotic toothpaste formulations that help support good bacteria and freshen breath. Substituting inulin into the compositions of Schapiro would therefore predictably result in a toothpaste composition which is effective at maintaining a balance of oral microflora and reducing breath odor.
It would further have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to incorporate a zinc ion source of zinc citrate in an amount of from about 0.05 to about 5% and a menthol flavoring agent in the toothpaste formulation of Schapiro, as suggested by Rege. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in order to incorporate to an oral composition an agent with antibacterial properties in an amount that is effective to inhibit erosion, and a flavoring agent known to be suitable for use toothpaste formulations, as suggested by Rege. There is a reasonable expectation of success as Schapiro teaches that toothpaste compositions are used to clean and improve the health and aesthetic appearance of the teeth and can comprise flavorants for enhancing the taste and smell sensations when brushing one’s teeth (column 5, lines 50-53), and Tom’s of Maine teaches that zinc citrate can be used in toothpaste formulations in combination with inulin and thickeners such as xanthan gum.
Claims 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Schapiro, as evidenced by Deosen, in view of Doran, Tom’s of Maine, and Rege as applied to claims 1-2, 10, 12-15, and 21-32 above and further in view of Teferra (“Possible actions of inulin as prebiotic polysaccharide: A review”, Food Frontiers, published June 15, 2021, 2, 407-416; of record).
The teachings of the modified Schapiro are described above. Specifically, regarding instant claims 3 and 20, Schapiro provides in alternative example 2 an example where inulin is present from 0.2-0.7 wt.% and a combination of konjac gum and xanthan/guar are present from 1.15-4.55 wt.%; this provides a range of ratios of fructan to thickening agent from 0.04:1 to 0.6:1. The amount of fructan and weight ratio of fructan and thickening agents overlap the ranges of instant claim 20. From MPEP 2144.05: “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).”
The combination of Schapiro, Doran, Tom’s of Maine, and Rege do not teach the limitation of instant claim 3 that the inulin comprises a degree of polymerization of from 2 to about 60 or of instant claim 20 that the inulin comprises a degree of polymerization of from 2 to less than 10.
Teferra teaches that inulin acts as a prebiotic dietary fiber that stimulates the growth and activities of health beneficial microorganisms (abstract). Teferra further teaches that in plants, inulin naturally exists as a mixture of oligo- and polysaccharides of fructose ranging from 2 to 100 units depending on plant species, age and extraction techniques (pg. 407, “1.1 What is inulin?”). They further teach that the physicochemical and functional properties of inulin are linked to degree of polymerization (DP) and that the short-chain inulin fraction, (oligofructose [OF], DP < 10), is much more soluble and sweeter than native and long-chain inulin, and can contribute to improved mouthfeel (pg. 409, column 1, paragraph 1). Teferra further teaches that the solubility of inulin is dependent on DP, and the solubility of inulin decreases with increase in DP (pg. 409, column 1, paragraph 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to use inulin with a degree of polymerization of < 10, as taught by Teferra, in the compositions of the modified Schapiro. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in order to use a form of prebiotic inulin that is soluble and has improved mouthfeel, as suggested by Teferra. There is a reasonable expectation of success as Schapiro teaches toothpaste compositions comprising inulin and water, and Doran and Tom’s of Maine further teach inulin for use in prebiotic oral care compositions. Further, MPEP 2144.05: "[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. 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)."
Response to Arguments
Applicant’s arguments filed 07/09/2025 have been fully considered.
Regarding the claim rejections under 35 USC § 101, Applicant argues that the claimed composition possesses characteristics that are markedly different from its individual components as they occur in nature, that the claim is tied to a practical application, and that the claim recites an inventive concept. Specifically, Applicant argues that the key characteristic of the claimed invention is its stability against crystallization in a specific, artificial, multi-component chemical environment (containing fructans, a zinc ion source, humectants, and flavorant) under the stress of freezing temperatures; in nature, inulin does not exist in a stable aqueous solution with zinc ions, menthol, and xylitol at -10° C. The claimed composition is a man-made formulation that exhibits a new state of stability that its components do not possess in their natural state, and this constitutes a markedly different characteristic. Applicant argues that the claims as a whole are not directed to the natural products themselves, but to a man-made stable oral care product formulation solving a non-natural problem of a formulation capable of withstanding the rigors of manufacturing, shipping, and storage in climates where freezing temperatures are common, without undergoing crystallization, and that the claim limitations of the orally acceptable vehicle, zinc ion source, specific ratio of fructans to thickening agents, and functional limitations are inextricably tied to this practical application. Applicant argues that the claim provides an inventive concept of the discovery that the specific combination of fructans with a zinc ion source and a narrow range of xanthan gum can prevent product degradation which is "significantly more" than the judicial exception itself, as it is a specific, non-obvious solution to a technical problem that yields a new and useful composition with improved properties.
These arguments are unpersuasive. The Examiner respectfully maintains the position that the claims are not patent eligible subject matter under 35 USC § 101. Per the guidance of MPEP 2106.04(c), “The courts have emphasized that to show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart. Myriad, 569 U.S. at 580, 106 USPQ2d at 1974-75. Thus, in order to be markedly different, the inventor must have caused the claimed product to possess at least one characteristic that is different from that of the counterpart. If there is no change in any characteristic, the claimed product lacks markedly different characteristics, and is a product of nature exception. If there is a change in at least one characteristic as compared to the counterpart, and the change came about or was produced by the inventor’s efforts or influences, then the change will generally be considered a markedly different characteristic such that the claimed product is not a product of nature exception.”
In the instant case, the claims are directed to an oral care composition with the characteristic that the one or more thickening agents are effective to prevent crystallization of the one or more fructans in the orally acceptable vehicle upon exposure to temperatures at about 0 °C or less (see instant claim 1) and exposure to a temperature of about -10 °C (see instant claim 32). The claims further recite the characteristic that the one or more fructans are effective to treat or prevent oral malodor (see instant claim 21), and the one or more thickening agents are effective to modify the viscosity of the composition (see instant claim 23). As set forth in the above rejections, naturally occurring inulin is known to treat oral malodor, and naturally occurring xanthan gum is known to act as a thickening agent and to prevent crystallization.
The evidence of record does not demonstrate that the claimed combination of one or more thickening agents, one or more fructans, and a source of zinc ions has achieved a characteristic that is changed compared to their naturally occurring counterparts. In particular, the present evidence does not demonstrate that fructans (particularly inulin) crystallize upon exposure to temperatures at about 0 °C and that the addition of one or more thickening agents (particularly xanthan gum) has modified a property of the fructans. The example presented (paragraphs [0075]-[0078] and Table 1) compare an oral care composition with no xanthan gum present to one with xanthan gum present and containing a slightly higher amount of preservative. The specification states that the control composition exhibited the formation of needle-like crystals upon exposure at a temperature of about -10 °C for a month and that “it is believed that the crystal formation is the result of interaction between the inulin and one or more components of the oral care composition, such as, a flavorant (i.e., methanol)” (paragraph [0077]). The specification does not provide evidence that these crystals are in fact inulin. The specification further does not provide evidence that the property of crystallization/precipitation is a property of inulin as it occurs in nature, absent other oral care components such as flavorants.
The Examiner further maintains the position that claims do not recite anything else, compositionally or structurally, which provides an inventive concept that departs from merely reciting a composition containing all naturally occurring components, the composition having properties that are consistent with the naturally occurring counterparts of the components of the composition. Adjusting the amounts and ratios of components would not rise to substantially more than the judicial exception.
For these reasons, and the reasons set forth in the above rejections, the claim rejections under 35 USC § 101 are maintained, slightly modified to address the amended claims.
Regarding the claim rejections under 35 USC § 103, Applicant argues that there is no indication that formulations of the prior art are designed to address a low-temperature inulin crystallization problem; there is no recognition of this problem, no appreciation that the presence of zinc ions exacerbates it, and no teaching that the specific ratio of fructans to the thickening agents is required to solve this problem. Applicant argues that the Examiner’s proposed combination constitutes impermissible hindsight as it uses the Applicants’ disclosure as a roadmap to piece together disparate elements from the prior art to solve a problem that the prior art never identified. Applicant argues that the path from the cited art to the claimed invention is not a straightforward one and requires the discovery of a latent technical problem (lowtemperature crystallization) and the targeted experimentation to find a specific solution (the critical amounts of xanthan gum and zinc ions).
These arguments are unpersuasive. The Examiner respectfully maintains the position that the instant claims are merely reciting a latent property that will necessarily follow from following the teachings of the prior art set forth above. Per MPEP 2145 II: “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)” and “’The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”.
The Examiner submits that, as set forth above, the prior art provides motivation and a reasonable expectation of success in arriving at the structural components of the claimed composition in order to reach a toothpaste composition which is effective at maintaining a balance of oral microflora, reducing breath odor, and inhibiting erosion. The teachings of the prior art render obvious the structural components of the claimed oral care compositions with ranges of inulin, thickening agents, and ratio between the two overlapping those instantly claimed and described in the instant specification as effective to prevent crystallization upon exposure to temperatures at about 0 °C or less or about -10 °C. As the structural components of the composition are obvious over the prior art, absent evidence to the contrary, the physical properties of preventing crystallization of one or more fructans upon exposure to an accelerated aging condition as claimed would necessarily follow, regardless of whether that property is explicitly taught in the prior art.
Regarding the argument that the instant invention required the targeted experimentation to find a specific solution (i.e., the critical amounts of xanthan gum and zinc ions), the Examiner cites to MPEP 716.02(d), which states, “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support."” and “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).”
Here, the evidence of record (see Table 1 of the specification) demonstrates a single combination of xanthan gum and inulin, a single concentration of zinc, and a single 1:1 ratio of xanthan gum to inulin; independent claim 1 is much broader in scope, inclusive of the combination of any one or more fructans with any one or more thickening agents in a ratio of from about 0.1:1 to about 10:1. The evidence of record is not commensurate in scope with the claimed invention, and the Examiner cannot conclude that the evidence demonstrates the criticality of the claimed ranges.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUDITH M KAMM whose telephone number is (703)756-4575. The examiner can normally be reached M-F 8:00 am-4:30 pm EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/J.M.K./Examiner, Art Unit 1611
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