DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Receipt and consideration of Applicant’s amended claim set and Applicant’s arguments/remarks submitted on November 7, 2025 are acknowledged.
All rejections/objections not explicitly maintained in the instant office action have been withdrawn per Applicant’s claim amendments and/or persuasive arguments. Applicant’s claim amendments have necessitated new grounds of rejections set forth below.
Status of the Claims
Claims 1-8 are pending and under consideration in this action.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 7, 2025 has been entered.
Change in Examiner
The examiner for your application in the USPTO has changed. Examiner Monica Shin can be reached at 571-272-7138.
Claim Interpretation
Claim 1 contains the transitional language “consisting essentially of”. For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, “consisting essentially of” will be construed as equivalent to “comprising.” If an applicant contends that additional steps or materials in the prior art are excluded by the recitation of “consisting essentially of,” applicant has the burden of showing that the introduction of additional steps or components would materially change the characteristics of applicant's invention. PPG Industries Inc. V Guardian Industries Corp. 48 USPQ2d 1351 (Fed. Cir. 1998) and In re De Lajarte 337 F.2d 870, 143 USPQ 256 (CCPA 1964) See MPEP 2111.03.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Götz et al. (Götz) (US 2019/0388485 A1; published Dec. 26, 2019), Stein (Probiotics and Prebiotics are necessary for Dental Health; published Mar. 2, 2018), and Farber et al. (Farber) (US 2007/0196496 A1; published Aug. 23, 2007).
Götz discloses microorganisms or mixtures thereof for use as an anti-inflammatory agent in the oral cavity for reducing or inhibiting the release of certain inflammatory factors. The microorganisms are used in the treatment and/or prevention of inflammation in the oral cavity, in particular for use in the treatment and/or prevention of dental caries and/or periodontal disease. (abstract; para.0001-0003).
With regards to Claim 1, Götz discloses the treatment and/or prevention of inflammation in the oral cavity by administration of microorganisms or mixtures thereof to a subject/patient, preferably to a subject/patient in need thereof, preferably in an amount sufficient to treat or prevent inflammation (para.0001-0003, 0048). Götz also discloses oral care composition or products for delivering the microorganism (par.0020). In particular, Götz discloses oral pharmaceutical compositions, oral care products, or products for nutrition or pleasure comprising one or more of the microorganisms as probiotic agents (abstract; para.0001-0003).
The microorganisms for use in the prevention and/or treatment of inflammation in the oral cavity includes the use in the prevention and/or treatment of plaque and plaques associated diseases and advantageously aides to avoid oral dysbiosis by balancing the mouth flora towards a healthy state (para.0029).
The composition may further comprise one or more components, such as analgetics, such as lidocaine or benzocaine (para.0039). Although Götz does not appear to explicitly disclose wherein the lidocaine or benzocaine are present in a therapeutic amount, because Götz explicitly discloses that the lidocaine or benzocaine is present in the composition as an analgetic, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to include lidocaine or benzocaine in an amount sufficient to provide analgetic properties when the composition is administered.
With regards to Claim 2, among the suitable microorganisms for use in Götz’s treatment methods include Lactobacillus plantarum, such as Lactobacillus plantarum Heal19 (para.0022). Götz discloses that Lactobacillus plantarum Heal19 was selected as a potent agent for modulation of anti-inflammatory responses (para.0026).
With regards to Claim 4, the composition or product may be in the form of toothpaste (para.0043). Although Götz does not appear to explicitly disclose application of the toothpaste onto the teeth, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to do so as it is well known and conventional for toothpaste to be applied to the teeth.
With regards to Claim 5, the composition or product may be in the form of mouth wash (para.0043).
With regards to Claim 6, the composition or product may be in the form of chewing gum (para.0043).
With regards to Claim 7, the composition or product may be in the form of a mouth spray (para.0043). Although Götz does not appear to explicitly disclose wherein the mouth spray is applied by spraying in the oral cavity, one of ordinary skill in the art would have found it prima facie obvious and would have been motivated to do so as it is well known and conventional for mouth sprays to be used by spraying into the oral cavity.
Götz does not appear to explicitly disclose the inclusion of one of more prebiotics. Stein and Farber are relied upon for this disclosure. Their teachings are set forth herein below.
Stein discloses that probiotics and prebiotics have been shown to have substantial health benefits when administered as a dental care solution in the oral cavity (p.1, para.1). Stein discloses that prebiotics are dietary substances that favor the growth of beneficial bacteria over harmful ones. They empower the existing good bacteria (or good bacteria introduced through probiotics) to survive and establish a balanced ratio of good-to-bad bacteria using nutrients to influence the oral environment (p.1, para.2).
Stein discloses that while probiotics and prebiotics have proven health benefits exclusively and don’t need to be taken together, it is believed that the two can be even more effective when working synergistically. Both have shown the capability of neutralizing pH (cavity prevention), decreasing inflammation, disrupting biofilm (dental plaque), and balancing the microbiota when consumed (p.1, para.3).
Stein discloses that there are commercially available dental prebiotic formulations, including toothpaste and oral care lozenges (p.1, para.4).
Farber discloses oral delivery systems for functional ingredients (para.0024). Among the suitable functional ingredients that may be included in the oral delivery systems include probiotics and prebiotics (para.0131-0134). The prebiotics can be delivered in combination with probiotic bacteria in the delivery system (para.0134).
Prebiotics comprise carbohydrates, generally oligosaccharides. Oligosaccharides may be produced from glucose, galactose, xylose, maltose, sucrose, lactose, starch, xylan, hemicellulose, inulin, or a mixture thereof (para.0134). Purified commercially available products such as fructooligosaccharide contain greater than about 95% solids in the form of oligosaccharides. Prebiotics often comprise a mixture of fructooligosaccharide and inulin. A prebiotic of this kind has been demonstrated to improve the response of the immune system (para.0134).
With regards to the inclusion of prebiotics (Claims 1 and 3), as discussed above, Götz discloses oral care products comprising probiotics and analgetic (lidocaine or benzocaine) for use in treatment and/or prevention of inflammation of in the oral cavity and prevention and/or treatment of plaque and plaques associated diseases, and which advantageously aides to avoid oral dysbiosis by balancing the mouth flora towards a health state. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to combine the teachings of Götz with the teachings of Stein and Farber, and further include prebiotics, such as fructooligosaccharide, to Götz’s oral care products. One of ordinary skill in the art would have been motivated to do so in order to achieve the synergistic effect of the combination of probiotics and prebiotics, particularly as it relates to neutralizing pH (cavity prevention), decreasing inflammation, disrupting biofilm (dental plaque), balancing the microbiota, and improving immune system response. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Farber and Stein disclose that prebiotics and probiotics are known to be used in combination in orally administered formulations, and Stein discloses that prebiotics are known to be incorporated into oral care products, e.g., toothpaste.
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Götz et al. (Götz) (US 2019/0388485 A1; published Dec. 26, 2019), Stein (Probiotics and Prebiotics are necessary for Dental Health; published Mar. 2, 2018), and Farber et al. (Farber) (US 2007/0196496 A1; published Aug. 23, 2007) as applied to Claims 1-7 set forth above, further in view of Stanley et al. (Stanley) (US 6,258,384 B1; published Jul. 10, 2001).
The teachings of Götz, Stein, and Farber and the motivation for the combination as they apply to Claims 1-7 are set forth above and incorporated herein. Additional relevant teachings of Götz are set forth herein below.
Götz further discloses that the product may be in the form of lozenges (para.0042).
The combined teachings of Götz, Stein, and Farber do not appear to explicitly disclose wherein the composition is a form of frozen formulation, wherein the composition is applied as the frozen formulation (Claim 8). Stanley is relied upon for this disclosure. The teachings of Stanley are set forth herein below.
Stanley discloses a frozen nutritional food product and method for oral delivery of nutrients, medicinal substances, and other active ingredients via absorption through the oral mucosa for systemic effect (abstract; col.2, ln.50-55; col.3, ln.18-35).
Stanley discloses that children prefer the frozen composition over other means of obtaining vitamins and nutrients because the composition contains flavors and sweeteners and is provided in the form of a frozen product, which resembles a favorite refreshing dessert, namely an ice pop or popsicle (col.3, ln.7-11).
Stanley discloses that for athletes, the frozen composition provides a means to quickly absorb nutrients, replace fluids, and to rapidly cool the athlete (col.3, ln.12-14).
Stanley discloses that infirm patients who have upset stomachs or lack of appetite may find the frozen composition to be more convenient and soothing way to obtain nutrients (col.3, ln.15-17).
As discussed above, Götz discloses oral pharmaceutical compositions, oral care products, or products for nutrition or pleasure. One of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the instant invention to further combine the teachings of Götz, Stein, and Farber with the teachings of Stanley and provide the product of the combined teachings of Götz, Stein, and Farber as a frozen product for oral delivery in frozen form as disclosed by Stanley. One of ordinary skill in the art would have been motivated to do so in order to provide a delivery form that is beneficial to broader populations, including children, athletes, and infirm patients. One of ordinary skill in the art would have had a reasonable expectation of success in doing so as Götz discloses that their orally administered products may be in the form of products for nutrition or pleasure, and include forms where active ingredients are absorbed through the oral mucosa for systemic effect (e.g., lozenge).
Therefore, the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, because the combined teachings of the prior art references is fairly suggestive of the claimed invention.
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered. In light of Applicant’s claim amendments, new rejections are set forth above, which cite new combination of references not addressed in Applicant’s argument.
Conclusion
Claims 1-8 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MONICA A. SHIN whose telephone number is (571)272-7138. The examiner can normally be reached Monday-Friday (9:00AM-5:00PM EST).
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/MONICA A SHIN/Primary Examiner, Art Unit 1616