Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/20/25 has been entered.
Claims Status
3.Applicants’ amendment filed August 14, 2026, acknowledged. Claims 1 and 9 have been amended. Claims 6, 8, 10 and 12-15 have been cancelled. Claims 1-5, 7, 9 and 11 are under examination.
Rejections Withdrawn
4. The following are withdrawn from the Office Action filed March 7, 2026, based on Applicant’s arguments.
The rejection of claims 1, 4-5, 7, 9 and 11 under 35 U.S.C. 102 (a)(1) and 102 (a)(2), pages 4-7 of the previous Office action.
The rejection of claims 1-5, 7, 9 and 11 under 35 U.S.C. 103(a), pages 7-9 of the previous Office action.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claim 4 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites “a molecular weight of 5000 Da or less”. This recitation is indefinite because the lower end of the molecular weight range could be zero. Correction is required.
Claim Rejections - 35 USC § 103
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.
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.
6. Claim(s) 1-2, 7, 9, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagai et al (JP2019011268A published January 24, 2019) in view of Jiang et al (BMC Microbiology (2016), 16:149).
Claim 1 is drawn to a method for inhibiting biofilm produced by Streptococcus mutans in an oral cavity, comprising administering to the oral cavity of an individual in need thereof (i) at least one selected from the group consisting of Lactobacillus rhamnosus, its culture medium, its extract, and its cell-free supernatant; and (ii) collagen hydrolysate.
Claim 2 is drawn to the method of claim 1, wherein the Lactobacillus rhamnosus is Lactobacillus rhamnosus GG DSM 33156.
Claim 7 is drawn to the method of claim 1, wherein the method promotes growth of Streptococcus oralis in the biofilm.
Claim 9 is drawn to a method for preventing or treating oral diseases caused by biofilm produced by Streptococcus mutans, comprising administering to the oral cavity of an individual in need thereof (i) at least one selected from the group consisting of Lactobacillus rhamnosus, its culture medium, its extract, and its cell-free supernatant; and (ii) collagen hydrolysate.
Claim 11 is drawn to the method of claim 9, wherein the oral disease includes at least one selected from the group consisting of dental caries, periodontitis, stomatitis, gum recession, gum hypertrophy and gingivitis.
Nagai et al teach that to maintain a good balance of indigenous bacteria in the oral cavity, includes selectively exerting an antibacterial effect against pathogenic bacteria in the oral cavity. Nagai et al teach compositions containing bacterium, a bacterium culture or an extract thereof Lactobacillus ramnosus KO3 strain as an oral indigenous bacterium regulator to suppress the growth of non-pathogenic bacteria in the oral cavity (see the Abstract). Nagai et al teach in human cavities a very wide variety of oral bacteria exceeding 700 species have been found including Streptococcus mutans (see the Description section). Nagai et al teach that, Streptococcus mitis and Streptococcus oralis and other Streptococcus non-pathogenic bacteria are involved in tooth surface adhesion and periodontal disease (see the Description section). Nagai et al teach that both Streptococcus mitis and Streptococcus oralis are involved in forming biofilm and are early colonizers. Nagai et al teach a composition comprising Lactobacillus ramnosus KO3 strain, cell cultures or extracts as agents to control the non-pathogenic growth, treat dental caries, periodontal disease and have antibacterial effect in the oral cavity (see the Description section). Nagai et al teach that the Lactobacillus compositions to control growth of nonpathogenic bacteria in the oral cavity can be formulated in mouthwash, gummies or tablets (see the Description section).
Nagai et al do not teach the claim limitation “wherein the Lactobacillus rhamnosus is Lactobacillus rhamnosus GG DSM 33156 (LGG)”.
Jiang et al teach the strains of Lactobacillus rhamnosus GG DSM 33156 have the ability to integrate all multi-bacterial species oral biofilms and reduce the amounts of multiple bacteria and Candida albicans. Also, Candida albicans significantly promoted the growth of LGG (see the Abstract). Jiang et al concluded that probiotics could be plausible towards prevention and management of infectious disease by alteration of biofilm compositions (see the Conclusion section). Jiang et al teach that LGG was able to inhibit the growth of oral pathogens and opportunistic pathogens (page 7, left column).
It would have been prima facie obvious at the time the invention was made to include Lactobacillus rhamnosus GG DSM 33156 (LGG) in the compositions used in the method of inhibiting biofilm of Nagai et al because Jiang et al teach strains of Lactobacillus rhamnosus GG DSM 33156 have the ability to integrate all multi-bacterial species oral biofilms and inhibit the growth of oral pathogens and opportunistic pathogens. One of ordinary skill in the art would be motivated to select LGG to be combined in the composition of Lactobacillus for inhibiting pathogenic bacteria in the oral cavity as taught by Nagai et al because it is obvious to combine equivalents known for the same purpose. See MPEP 2144.06. "It is prima facie obvious to combine two compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from there having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine)”.
Additionally, applying a known product to a known method ready for improvement to yield predictable results is likely to be obvious. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, D.).
Accordingly, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
7. Claim(s) 3-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nagai et al (JP2019011268A published January 24, 2019) in view of Jiang et al (BMC Microbiology (2016), 16:149) as applied claims 1-2, 7, 9 and 11 above and further in view of Znamirowska et al 2020 (Probiotic Fermented Milk with Collagen; Dairy Vol. 1, pp 126-134).
Claim 3 is drawn to the method of claim 2, comprising administering the Lactobacillus rhamnosus in a composition having a Lactobacillus rhamnosus concentration of 1.0 x 105 to 1.0 x 1012 CFU (colony-forming unit)/ml.
Claim 4 is drawn to the method of claim 1, wherein the collagen hydrolysate has a molecular weight of 5000 Da or less.
Claim 5 is drawn to the method of claim 1, wherein the collagen hydrolysate inhibits acid production of Lactobacillus rhamnosus or Streptococcus mutans strains.
The teachings of Nagai et al and Jiang et al have been described previously.
Nagai et al and Jiang et al do not teach the claim limitations “comprising administering the Lactobacillus rhamnosus in a composition having a Lactobacillus rhamnosus concentration of 1.0 x 105 to 1.0 x 1012 CFU (colony-forming unit)/ml, wherein the collagen hydrolysate has a molecular weight of 5000 Da or less and wherein the collagen hydrolysate inhibits acid production of Lactobacillus rhamnosus or Streptococcus mutans strains”.
Znamirowska teaches methods comprising ingesting (i.e. oral administration; administration to the oral cavity) liquid compositions comprising both Lactobacillus rhamnosus (at about 109 cfu/g) and collagen protein hydrolysate (e.g. see abstract; Figure 1 and Table 2).
It would have been prima facie obvious at the time the invention was made to use the concentration of 1.0 x 105 to 1.0 x 1012 CFU of Lactobacillus rhamnosus collagen protein hydrolysates as taught by Znamirowska in the compositions used in the method of inhibiting biofilm of the combined teachings of Nagai et and Jiang et al because Znamirowska has demonstrated that these concentrations are effective as oral probiotics and suggests that using probiotic compositions improve bone and joint health.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements were already known in the art, as set forth above, and combining these elements merely yields a method wherein each element performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, it would have been obvious to a person of ordinary skill in the art to combine these prior art elements according to a known method to yield predictable results.
Accordingly, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
8. No claims allowed.
Conclusion
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vanessa L Ford whose telephone number is (571)272-0857. The examiner can normally be reached Monday to Friday 9:00 -5:30 EST.
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/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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