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 . Claims included in the prosecution are claims 1, 3-5, 8-12 and 15-23.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/22/2025 has been entered.
Applicants' arguments, filed 12/22/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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 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.
1. Claims 1, 4, 5, 8, 9, 11, 12 and 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over Stettler et al. (US 2016/0317414, Nov. 3, 2016) (hereinafter Stettler) in view of Sasaki et al. (US 2005/0118273, Jun. 2, 2005) (hereinafter Sasaki).
Stettler discloses method of enhancing a beneficial oral bacteria and decreasing harmful oral bacteria comprising administering oral care compositions comprising a saccharide prebiotic (abstract). Stettler tested a large number of sugar derivatives to identify substrates that would selectively favor the growth of beneficial bacteria while directly or indirectly suppressing the growth of harmful bacteria (¶ [0006]). The oral care composition comprising a saccharide prebiotic is found to increase the growth of Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga sputigena and Actinomyces naeslundii. The saccharide prebiotics negatively affect the growth of Streptococcus mutans, Prevotella intermedia, Porphyromonas gingivalis, Fusobacterium nucleatum, Tannerella forsythia, Aggregatibacter actinomycetemcomitans, and Streptococcus sobrinus (¶ [0007]). The composition can further comprise at least one species of bacteria that has beneficial effects on oral health, such as Streptococcus mitis, Streptococcus salivarius, Streptococcus sanguinis, Actinomyces viscosus, Veillonella parvula, Streptococcus gordonii, Capnocytophaga Sputigena, Actinomyces naeslundii and combinations thereof (¶ [0026]-[0027]). The oral care composition may be a mouthwash, toothpaste, tooth gel, tooth powder, non-abrasive gel, mousse, foam, mouth spray, lozenge, oral tablet, or dental implement (¶ [0041]). The amount of saccharide prebiotic is 0.1% to 5% by weight of the composition (claim 6). The oral care composition selectively promotes growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria (¶ [0081]). Additionally, the oral care composition selectively promotes biofilm formation by bacteria that have beneficial effects on oral health, relative to biofilm formation by pathogenic oral bacteria (¶ [0082]). Further provided is a method of preventing or mitigating one or more of gingivitis, periodontitis, peri implantitis, peri-implant mucositis, necrotizing gingivitis, necrotizing periodontitis and caries in a subject, by selectively promoting, in an oral cavity of a subject: growth, metabolic activity or colonization of bacteria that have beneficial effects on oral health, relative to growth, metabolic activity or colonization of pathogenic oral bacteria, the method comprising contacting an oral cavity of the subject with the oral care composition (¶ [0076]). The composition comprises a surfactant (¶ [0098]). The surfactant is at least one selected from sodium lauryl sulfate, cocamidopropyl betaine, and combinations thereof (¶ [0030]).
Stettler differs from the instant claims insofar as not disclosing D-(+)-trehalose or D-(+)-raffinose as the saccharide prebiotic.
However, Sasaki discloses wherein sweeteners (including saccharides) include monosaccharides, disaccharides, oligosaccharides, sugar alcohols and high intensity sweeteners. Disaccharides include trehalose (i.e., D-(+)-trehalose per PubChem reference of record). Oligosaccharides include raffinose (i.e., D-(+) raffinose per PubChem reference of record) (¶ [0126]).
Stettler discloses testing various sugar derivatives to identify substrates that would selectively favor the growth of beneficial bacteria while directly or indirectly suppressing the growth of harmful bacteria. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated D-(+)-trehalose or D-(+)-raffinose as the saccharide prebiotic in order to test their effectiveness since they are known saccharide sugars as taught by Sasaki.
In regards to instant claims 15-18, since the composition of the prior art comprises substantially the same saccharide prebiotic as claimed, the composition of the prior art necessarily has the properties recited in claims 15-18.
In regards to instant claims 19 and 20 reciting wherein the composition is in an amount sufficient to decrease the gene expression of one or more inflammatory biomarker in oral keratinocytes, as noted in the instant specification, the amount of saccharide prebiotic is about 0.5%, 1% or 2%. Steller discloses the amount of saccharide prebiotic is 0.1% to 5%. As such, since the prior art comprises substantially the same amount of saccharide prebiotic as the claimed invention, the composition of the prior art is in an amount sufficient to decrease the gene expression of one or more inflammatory biomarker in oral keratinocytes.
2. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Stettler et al. (US 2016/0317414, Nov. 3, 2016) (hereinafter Stettler) in view of Crater (US 2014/0113888, Apr. 24, 2014).
The teachings of Stettler are discussed above. Stettler does not disclose α-D-lactose as the saccharide prebiotic.
However, Crater discloses a product suitable for oral administration (claim 12). The composition may comprise a mono-, di or poly-saccharide (e.g., lactose). The lactose may be anhydrous lactose (i.e., α-D-lactose per PubChem reference of record) (¶ [0063]).
Stettler discloses testing various sugar derivatives to identify substrates that would selectively favor the growth of beneficial bacteria while directly or indirectly suppressing the growth of harmful bacteria. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated α-D-lactose as the saccharide prebiotic in order to test its effectiveness since it is a known saccharide as taught by Crater.
Response to Arguments
Applicant argues that although Sasaki discloses certain exemplary sugars such as trehalose and raffinose, Sasaki discloses the sugars as sweeteners but don’t does not purport to limit the potential saccharide prebiotics to those expressly disclosed.
The Examiner does not find Applicant’s argument to be persuasive. According to MPEP 2123, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Therefore, it is not necessary for Sasaki to disclose an embodiment with the claimed saccharide in order for the use of the saccharides to have been obvious. As such, Applicant’s argument is unpersuasive.
Applicant argues that one of ordinary skill in the art would recognize that numerous additional sugars and saccharide compounds – beyond those identified in Sasaki – are available for selection, including monosaccharides, disaccharides, oligosaccharides, polysaccharides, and chemically modified derivatives thereof. Each of these classes encompasses a wide range of structurally distinct compounds, well beyond the finite number of predictable solutions required for an obvious to try rationale.
The Examiner does not find Applicant’s argument to be persuasive. As discussed previously, Stettler still tested a large number of sugar derivatives even though there are a large number of sugars from which derivatives can be derived from. Therefore, since Stettler tried, it would have been obvious to one of ordinary skill in the art to have tried as well. Applicant has not explained why testing a large number of sugars would not have been obvious when Stettler did so. Also, Sasaki does not disclose an infinite number of sugars in paragraph [0126]. Paragraph [0126] discloses specific examples of sugars. Thus, there is a finite number of sugars in paragraph [0126] for one to try. Although Sasaki discloses classes of sugars, where the prior art teachings lead one of ordinary skill in the art to a narrower set of options, then that reduced set is the appropriate one to consider when determining obviousness using an obvious to try rationale. See MPEP 2142(I)(E) Example 6. Applicant has not explained why paragraph [0126] would not be a finite number of predictable solutions. As such, Applicant’s argument is unpersuasive.
Applicant argues that the Examiner’s own recognition of the magnitude of sugar derivatives contradicts the finite number of predictable solutions required for an obvious to try rationale.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Sasaki discloses a finite number of predictable solutions in paragraph [0126]. Therefore, Applicant’s argument is unpersuasive.
Applicant argues that the mere knowledge of the existence of other sugars does not establish a reasonable expectation that any particular sugar would selectively enhance beneficial oral bacteria while suppressing harmful strains.
The Examiner does not find Applicant’s argument to be persuasive. As discussed previously, Stettler discloses wherein some saccharides are prebiotic and it would be unreasonable to assume Stettler tested every single known sugar derivative due to the magnitude of sugar derivatives that exists. Therefore, one of ordinary skill in the art would have been motivated to test other saccharides not disclosed by Stettler but are known in the art to see if they are prebiotic. Such selective biological activity may be unpredictable, but there is a reasonable expectation for success since Stettler discloses wherein some saccharides are prebiotic and wherein it is within the skills of one of ordinary skill in the art to test a large number of saccharides. As such, Applicant’s argument is unpersuasive.
Applicant argues that MPEP 2112 pertains to inherency, but inherency applied only where the prior art necessarily includes the claimed feature.
The Examiner does not find Applicant’s argument to be persuasive. MPEP 2112 states wherein inherency arises both in the context of anticipation and obviousness. Therefore, Applicant’s argument that MPEP 2112 only applies to when the art anticipates the claimed feature is not persuasive. As discussed previously, Applicant specifically disclose that they found that D-(+)-trehalose and D-(+)-raffinose increase the growth of beneficial bacteria and negatively affect the growth of certain pathogenic strains of bacterial and therefore the claimed invention is not obvious. However, such finding is not persuasive to overcome the rejection. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See MPEP 2112(I). Applicant has not addressed this argument. Therefore, Applicant’s argument is unpersuasive.
Conclusion
Claims 1, 3-5, 8-12 and 15-23 are rejected.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRACY LIU whose telephone number is (571)270-5115. The examiner can normally be reached Mon-Fri 9 am - 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at 571-272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TRACY LIU/Primary Examiner, Art Unit 1614