DETAILED ACTION
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 .
2. Please note that the Patent Examiner of your application has changed. All communications should be directed to Mary Lyons, Art Unit 1645, whose telephone number is (571)272-2966.
Claim Status
3. The amendment, filed 01/23/26, has been entered. Claims 1-5, 7, 9 and 11 are pending and under examination. Claims 6, 8, and 12-15 are cancelled. Claims 1, 5 and 9 are amended.
Withdrawal of Objections/Rejections
4. The following are withdrawn from the Office Action, filed 10/23/25:
The rejection of claims 2-3 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement (i.e. a biological deposit rejection), found on page 2 at paragraph 1, is withdrawn in light of Applicant’s persuasive argument and evidence that a biological deposit is not necessary (see Remarks, page 4).
The rejection of claims 1 and 4-11 under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Ghannoum (US 2021/0030818), found on page 6 at paragraph 2, is withdrawn in light of Applicant’s amendments thereto; specifically adding the limitation of “…produced by Streptococcus mutans in an oral cavity…”.
The rejection of claims 1 and 4-11 under 35 U.S.C. 102(a)(1) as being anticipated by Znamirowska et al. 2020 (Dairy V1: 126-134) found on page 7 at paragraph 3, is withdrawn in light of Applicant’s amendments thereto; specifically adding the limitation of “…produced by Streptococcus mutans in an oral cavity…”.
The rejection of claims 1 and 4-11 under 35 U.S.C. 102(a)(1) as being anticipated by Gaosong et al. (CN110786506), found on page 8 at paragraph 4, is withdrawn in light of Applicant’s amendments thereto; specifically adding the limitation of “…produced by Streptococcus mutans in an oral cavity…”.
New Rejections Necessitated by Applicant’s Amendments
New Rejection: Claim Rejections - 35 USC § 102 and 103
5. 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.
6. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
7. 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.
8. 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.
9. 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.
10. Claims 1, 4-5, 7, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ghannoum (US 2021/0030818).
Ghannoum teaches methods for preventing and/or disrupting biofilms comprising administering therapeutic compositions comprising collagen peptides (i.e. collagen hydrolysates) and Lactobacillus rhamnosus to the oral mucosa of subjects in need thereof, for example, for treating and/or preventing dental caries (e.g. [0016-0018; 0053; 0071-0074, 0236]; meeting limitations found in newly amended claims 1 and 9, along with claims 4 and 11). Ghannoum teaches compositions comprising as little as 1000 mg of the collagen peptides (e.g. [0121]) and that the dosage is selected by an ordinary artisan and is typically 20-30 billion bacteria (i.e. 2-3 x 107; see [0118] and Table 7). Ghannoum provides a proof-of-concept example wherein the biofilms produced by the pathogenic microorganisms Candida tropicalis, Escherichia coli, and Serratia marcescens, were inhibited (e.g. see Example 1).
Therefore, although Ghannoum clearly identifies Streptococcus mutans as one of the undesirable bacterial species found within a typical oral biofilm (e.g. see [0071, 0074]), Ghannoum does not explicitly provide an example wherein the biofilm (or the disease thereof) was caused by a biofilm produced by Streptococcus mutans, as found in newly amended claims 1 and 9; also see MPEP 2164.02.
However, Ghannoum does teach the only positively recited step in each of the independent method claims (i.e. administering compositions comprising Lactobacillus rhamnosus and collagen hydrolysates); and MPEP 2112.02 states when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. (emphasis added); see In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978) (Claims 1 and 6, directed to a method of effecting nonaddictive analgesia (pain reduction) in animals, were found to be anticipated by the applied prior art which disclosed the same compounds for effecting analgesia but which was silent as to addiction. The court upheld the rejection and stated that the applicants had merely found a new property of the compound and such a discovery did not constitute a new use. See also In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966) "While the references do not show a specific recognition of that result, its discovery by appellants is tantamount only to finding a property in the old composition." 363 F.2d at 934, 150 USPQ at 628 (emphasis in original)).
Therefore, with regards to the limitation found in the preamble (i.e. “…for inhibiting biofilm produced by Streptococcus mutans in an oral cavity”); along with “… wherein the collagen hydrolysate inhibits acid production of Lactobacillus rhamnosus or Streptococcus mutans strains” in dependent claim 5 and “…wherein the method promotes growth of Streptococcus oralis in the biofilm” in dependent claim 7; it is noted that none of these limitations add a positively recited step to the claimed method and therefore, each has been interpreted as an expressions of an intended result; see MPEP 2111.04. Consequently, it is the Office’s position that Ghannoum anticipates the invention as claimed.
However, in the alternative, since the Office does not have the facilities for examining and comparing the intended results (e.g. inhibition of a Streptococcus mutans biofilm, in particular) of administering what appears to be the same, or substantially the same, composition as that of the prior art reference, the burden is now upon the Applicant to show an unobvious distinction between the structural and functional characteristics resulting from the administration of their claimed composition comprising Lactobacillus rhamnosus and collagen hydrolysate with the administration of the prior art’s composition also comprising Lactobacillus rhamnosus and collagen hydrolysate, as set forth above; See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Accordingly, the invention, as currently claimed, is anticipated by, or at the very least, is unpatentable over, Ghannoum.
New Rejection: Claim Rejections - 35 USC § 103
11. Claims 1-5, 7, 9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Znamirowska et al 2020 (Probiotic Fermented Milk with Collagen; Dairy Vol. 1, pp 126-134; of record) in view of Jiang et al. 2016 (Interactions between Lactobacillus rhamnosus GG and oral micro-organisms in an in vitro biofilm model; BMC Microbiology 16:1249) and Stage et al. 2020 (Lactobacillus rhamnosus GG Genomic and Phenotypic stability in an industrial production process; Appl. Envir. Microbiol. 2020, Vol. 86, Issue 6, e02780-19; submitted by Applicant in response filed 01/23/26).
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; meeting the only positively recited step in the methods of claims 1 and 9; also see MPEP 2112.02 and MPEP 2111.04). Znamirowska teaches that probiotic milk with collagen protein hydrolysate plays an important role in supplementing collagen protein hydrolysate deficiencies in the elderly and in the recovery of bone and joint injuries; and that collagen protein hydrolysate has proved to be a good milk additive by increasing gel hardness and reducing syneresis, without changing the taste or odor of the milk; (see section 5, conclusions).
Therefore the apparent difference between the prior art and the invention is that Znamirowska is silent with regards to the expression of the intended result of inhibiting a biofilm produced by Streptococcus mutans found in the preambles of independent claims 1 and 9, along with other intended results found in dependent claims 5, 7 and 11 and does not specify that the Lactobacillus rhamnosus is L. rhamnosus GG strain DSM 33156, as found in dependent claim 2.
However, Jiang demonstrates that Lactobacillus rhamnosus GG integrates oral biofilms and reduces adhesion of Streptococcus mutans in the oral cavity and concludes the benefits of using Lactobacillus rhamnosus as a probiotic in methods of prevention and/or management of oral diseases by altering the oral biofilm per se (e.g. see abstract; method section; and conclusion) and Stage teaches Lactobacillus rhamnosus GG, including DMS 33156, is one of the most widely marketed and studied probiotic strains with essential functional properties including persistence and stability (see abstract).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to use the methods taught by Znamirowska, comprising the consumption of probiotic milk containing Lactobacillus rhamnosus and collagen hydrolysates, in order to inhibit oral biofilms, including those produced by Streptococcus mutans in the oral cavity, thereby arriving at the claimed invention, because it was already known that Lactobacillus rhamnosus would integrate oral biofilms and reduce adhesion of Streptococcus mutans, as taught by Jiang. It also would have been prima facie obvious to use Lactobacillus rhamnosus GG DSM 33156, in particular, because Lactobacillus rhamnosus GG DSM 33156 was already recognized as a probiotic strain with favorable properties such as persistence and stability, as taught by Stage. Therefore, each and every element is taught in the prior art and the combination has a beneficial result; however, the combination amounts to no more than a predictable use of prior art elements according to their established functions.
The person of ordinary skill in the art would have been motivated to make the modification because Jiang had already taught that Lactobacillus rhamnosus was advantageous as a probiotic in methods of prevention and/or management of oral diseases by altering the oral biofilm and Stage had already taught that Lactobacillus rhamnosus GG DSM 33156 was one of the most widely marketed and studied probiotic strains with essential functional properties including persistence and stability.
The person of ordinary skill in the art would have had a reasonable expectation of success because Znamirowska had already taught the only positively recited step of the method (i.e. consumption of probiotic milk containing Lactobacillus rhamnosus and collagen hydrolysates); and Jiang had already demonstrated the results of having Lactobacillus rhamnosus interact with oral biofilms produced by Streptococcus mutans; and Stage had already taught the advantages of the particular GG DSM 33156 strain. Therefore, the combination leads to expected results because each element performs the same function as it does individually.
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.
Pertinent Art
12. The following prior art, made of record and not relied upon, is considered pertinent to applicant’s disclosure.
Hong et al. 2019 (Preparation of low-molecular weight, collagen hydrolysates (peptides): Current progress, challenges, and future perspectives; Food Chemistry 301: 1-10) teaches that collagen per se is a long and fibrous protein but when treated with physical, chemical or biological methods it easily hydrolyzes into hydrolysates which are called collagen peptides and have a range of molecular weights, including under 5000 Da (see abstract; introduction; section 3.4; and Table 1). Hong teaches lower molecular weight peptides are preferred because of their improved bioavailability (see introduction). Thus, it is the Office’s position that one of ordinary skill in the art would recognize that “collagen peptides” and “collagen hydrolysates” are equivalent terms and would necessarily encompass peptides under 5000 Da.
Conclusion
13. No claims are allowed.
14. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a).
15. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
16. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. 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, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/Examiner, Art Unit 1645
March 13, 2026