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 .
DETAILED ACTION
Applicant’s arguments filed after non-final office action on August 15, 2025 is acknowledged.
Claim 1 is pending in the instant application and is examined on the merits of this office action.
Maintained/Revised Rejections
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.
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.
Claim(s) 1 remains rejected under 35 U.S.C. 103 as being unpatentable over Seferovic (WO2015000082 A1) in view of Horn (EP3027058 B1, cited previously) and Taverniti (Frontiers in Microbiology, 2012, volume 3, pages 2-12) and Taverniti* (Genes Nutr. 2011 Apr 16;6(3):261–274).*All references cited previously.
Seferovic teaches a composition for use in oral hygiene comprising lactobacillus Helveticus (see claim 1). Seferovic teaches treating oral conditions or disease comprising orally administering the composition comprising lactobacillus Helveticus (see claims 1 and 24). Seferovic teaches wherein the composition is a food (claim 26) and treating candidiasis (fungal infection, claims 28). Seferovic is silent to wherein the lactobacillus helveticus is dead cells.
However, Horn teaches specifically Lactobacillus Helveticus as the probiotic in the food (see paragraph 0195). Horn additionally teaches wherein the probiotics can be heat/treated/killed and are preferred. Horn teaches “In some instances, heat-treated probiotics or probiotics that are otherwise rendered non-viable, and/or immune enhancing constituents derived from heat killed or non-viable probiotics, are preferred and are used in the compositions described herein. For example, heat killed Lactobacillis species have been shown to augment innate and acquired immunity in mammals” (see paragraph 0211).
Taverniti teaches that heat inactivated L helveticus cells were observed to maintain part of the antagonist activity, suggesting that the capacity of L helveticus to block pathogen invasion is not completely dependent on the presence of metabolically active bacterial cells and the capacity could be due to the presence of specific cell components, such as the S-layer protein, on the bacterial surface (see page 2, left column, end of first paragraph).
Taverniti* teaches “the use of killed/inactivated bacteria, as long as the beneficial effects are retained, would represent an advantage because it is possible to make these bacteria potentially harmless through a tailored inactivation treatment”. Taverniti teaches “noticeable advantage over probiotics of allowing for the generation of safer and more stable products” (see last paragraph).
It would have been obvious before the effective filing date of the claimed invention to kill/inactivate the Lactobacillus Helveticus of Seferovic for treatment of the oral fungal infection. One of ordinary skill in the art would have been motivated to do so given inactivated L. helveticus bacteria will retain the activity, be more stable and safer than using live bacteria. There is a reasonable expectation of success given that Horn and Taverniti teach that heat inactivation of L helveticus maintains their activity and can be used in food compositions/supplements.
Regarding the limitation of “stimulate B-defensin production in oral epithelial cells of a subject”, Seferovic in view of Horn, Taverniti and Taverniti* teaches the same method of the instant claims including administering a drink comprising Lactobacillus Helveticus dead cells and thus, the result of stimulating B-defensin will necessarily occur.
Response to Applicant’s Argument
Applicant argues that Horn’s teaching that probiotics may be heat treated or killed is not a general teaching, but rather refers to specific strains of probiotics supported by particular research reports. Applicant argues that a person of ordinary skill in the art would not have understood Horn as providing a general motivation to inactivate Lactobacillus helveticus in Seferovic’s compositions.
Applicant’s arguments have been fully considered but not found persuasive. Horn (paragraph 0211) expressly teaches that “in some instances, heat treated probiotics or probiotics that are otherwise rendered non-viable…are preferred” in food compositions, and that “heat killed lactobacillus species have been shown to augment innate and acquired immunity in mammals”. These statement are not limited to any one strain but apply broadly to Lactobacillus species, including L. helveticus. A person of ordinary skill in the art would have understood that Horn provides motivation use inactivated L. helveticus in food based probiotic applications such as Seferovic’s oral compositions.
Applicant argues that Taverniti only demonstrates that inactivated L. Helveticus can block adhesion or invasion of bacterial pathogens (E. coli, campylobacter) in intestinal epithelial cells. Applicant contends that a person of ordinary skill would not have applied this teaching to fungal infections in oral epithelial cells.
Applicant’s arguments have been fully considered but not found persuasive. Taverniti teaches the broader principle that the immunomodulatory activity of inactivated L. helveticus is not dependent on viability, but is mediated by structural components such as S-Layer proteins. The fact that Tavernitis experimental examples involve intestinal epithelial cells does not limit the general teaching. Oral and intestinal epithelial cells are both mucosal epithelial tissues with shared innate immune mechanisms, including B-defensin production. A person of ordinary skill in the art would have reasonably expected such immunomodulatory effects to occur in oral epithelial cell as well, particularly in the context of Seferovic’s treatment of oral candidiasis.
Applicant argues that Taverniti’s statement that killed/inactivated bacteria are useful “as long as the beneficial effects are retained”, and argues that this teaching does not guarantee retained activity. Applicant contends that POSA would not have been motivated to used inactivated L. helveticus in Seferovic’s method without using specific evidence that beneficial effects against oral candidiasis would be retained.
Applicant’s arguments have been fully considered but not found persuasive. Taverniti provides experimental evidence that inactivated L. Helveticus cells retain activity, including the ability to block pathogen invasion. Thus, Taverniti does not merely present a condition statement, but rather affirms that beneficial effects are retained upon activation. A POSA would therefore have been motivated to apply this teaching to Seferovic’s method, with a reasonable expectation that inactivated L. helveticus would remain effective in stimulating mucosal epithelial defenses.
Applicant argues that because the effects of probiotics depend on pathogen strain and epithelial cell type, a person of ordinary skill in the art would not have had a reasonable expectation that inactivated L. helveticus would stimulate B-defensin production in oral epithelial cells to combat fungal infection.
Applicant’s arguments have been fully considered but not found persuasive. Seferovic already teaches treating oral candidiasis, a fungal infection of oral epithelial cells, with L. Helveticus. Thus, contact with oral epithelial cells is inherent in Seferovic’s disclosure. Taverniti teaches that inactivated L. helveticus retains immunodulatory activity, while Horn provides motivation to prefer heat killed probiotics in food compositions. B-defensins are known components of the innate immune response of mucosal epithelial cells. A POSA would have reasonably expected that administering inactivated L. helveticus to oral epithelial cells for treating candidiasis, as in Seferovic, would stimulate epithelial innate immune responses including B-defensin production. The claimed result is therefore an inherent and expected outcome of the combined teachings.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERINNE R DABKOWSKI whose telephone number is (571)272-1829. The examiner can normally be reached Monday-Friday 7:30-5:30 Est.
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/ERINNE R DABKOWSKI/Examiner, Art Unit 1654
/JULIE HA/Primary Examiner, Art Unit 1654