Antiviral treatment comprising blis containing probiotic products

Notice of AllowanceLatest

Sep 29, 2025

Notice of Allowance — application approved for patent grant

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Non-Final Office Action

Apr 17, 2025 · §102, §103, §112

Non-Final Office Action — all claims rejected under §102, §103, and multiple §112 grounds

This is a non-final action, so the applicant has three months (extendable to six) to respond. A typical response addresses the prior art rejections by arguing differences or amending claims, and resolves the §112 issues by clarifying claim language and pointing to supporting disclosure in the specification. An examiner interview is often valuable to understand the §112 concerns and explore allowable claim scope. An attorney typically handles this; if you'd like patentreply.ai to draft a response, click 'Get this drafted'.

Rejection groups (7)

§ 102(a)(1)Anticipationclaims 1-4, 10-12, 14-16, 25
Claim(s) 1-4, 10-12, 14-16 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Di Pierro et al (Drug, Healthcare and Patient Safety, Vol. 8, page 77-81. 21/11/2016; provided by Applicants).
Non-Final Office Action mailed Apr 17, 2025
Examiner theory
Di Pierro discloses the use of BLIS product S. salivarius K12 in the prevention of viral pharyngitis, laryngitis and “flu”, wherein BLIS K12 was formulated into slowly dissolving oral tablets (p78). It occasionally occurred that further agents such as antibiotics or ibuprofen/acetaminophen (anti-inflammatories) were also administered (p80-81). “Flu” in Di Pierro (p79) is described as acute respiratory infection, which is usually considered as most commonly caused by viral infections, can affect the upper and lower respiratory tract. Laryngitis is most commonly caused by a viral infection, and is considered part of the lower respiratory tract. Claim(s) 1-3, 11, 12 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaci et al (Applied and Environmental Microbiology p.
§ 102(a)(1)Anticipationclaims 1-3, 11-12, 25
Claim(s) 1-3, 11, 12 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaci et al (Applied and Environmental Microbiology p. 928 –934 February 2014 Volume 80 Number 3; 928-934).
Non-Final Office Action mailed Apr 17, 2025
Examiner theory
Kaci teaches that several S. salivarius strains isolated from the human pharynx are able to interfere with respiratory pathogens. The S. salivarius TOVE-R strain has been reported to be a successful antagonist of virulent streptococci involved in tooth decay or pharyngitis, such as Streptococcus mutans, Streptococcus sobrinus, and Streptococcus pyogenes , or pathogens involved in periodontitis. The inhibitory activity toward S. pyogenes and Streptococcus pneumoniae has been attributed to bacteriocin production. In addition, S. salivarius was found to be able to affect immune responses by inhibiting inflammatory pathways activated by the pathogens, suggesting a role in the modulation of human epithelial cell immune responses. Similarly, S. salivarius strain K12, used for several years in Ne
§ 103Obviousnessclaims 3-4, 8-9, 17-19
Claim(s) 3-4, 8, 9, 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Di Pierro et al (Drug, Healthcare and Patient Safety, Vol. 8, page 77-81. 21/11/2016; provided by Applicants) and Kaci et al (Applied and Environmental Microbiology p. 928 –934 February 2014 Volume 80 Number 3; 928-934) in view of Wescombe et al (Future Microbiology. Vol. 7(12): 1355-1371, 2012; provided by Applicants) and in further view of Accessed 15/06/2021 (BLIS Probiotics product webpage. https://blisprobiotics.com.au/product/travelprotect-travel-immune-booster/ ; provided by Applicants).
Non-Final Office Action mailed Apr 17, 2025
Examiner theory
Vol. 7(12): 1355-1371, 2012; provided by Applicants) and in further view of Accessed 15/06/2021 (BLIS Probiotics product webpage. https://blisprobiotics.com.au/product/travelprotect-travel-immune-booster/ ; provided by Applicants). The teachings of Di Pierro and Kaci et al are set forth above. Additionally, Wescombe et al defines probiotic S. salivarius K12 strains for therapeutic uses (see p1359; p1364, left-hand column; p1368, Summary Table). Wescombe indicates an anti-viral effect of the BLIS probiotic strains. The reference teaches other applications for the probiotic are upregulation of immunological defenses against respiratory viral infections. The difference from the claims and references lies in the specific virus treated (claims 4, 5, 7-9), administration (13), and specific furth
§ 112(b)Indefinitenessclaims 1-19, 25
Claims 1-19 and 25 are 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.
Non-Final Office Action mailed Apr 17, 2025
§ 112(a)Enablementclaims 10
Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
Non-Final Office Action mailed Apr 17, 2025
Examiner theory
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The specification lacks complete deposit information for the deposit of strains Glasglow 3 and DC0010. Because it is not clear that the properties of these strains are known and publicly available or can be reproducibly isolated from nature without undue experimentation and because the best mode disclosed by the specification requires the use of the plasmids, a suitable deposit for patent purposes is required. Accordingly, filing of evidence of the reproducible production plasmids, one of ordinary skill in the art could be assured to the ability to practice th
§ 112(a)Written descriptionclaims 1-9, 11-19, 25
Claims 1-9, 11-19 and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
Non-Final Office Action mailed Apr 17, 2025
Examiner theory
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The full breadth of the claims does not have proper written description. The purpose of the written description requirement is broader than to merely explain how to make and use; the applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the written description inquiry, whatever is now claimed. See Vas-Cath, Inc. v.
§ 112(a)Enablementclaims 1-19, 25
Claims 1-19 and 25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
Non-Final Office Action mailed Apr 17, 2025
Examiner theory
The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The instant specification has shown the effect of K12 on salivary IFN levels Materials: BLIS K12 lozenges (Throat Guard) available from Blis Technologies Limited, New Zealand. Methodology: Dosing regime: Four adult subjects took 12 lozenges: 4 every two hours. The specification also shows Interferon gamma ELISA assay Interferon gamma was detected in the saliva samples using an ELISA kit (BD Biosciences). One hundred ul of saliva sample supernatant was added to each well. The ELISA assay was conducted according to the manufacturer’s protocol. Additionally, K12 w

Prior art consulted (3)

Identifier	Type	Name or author	Link
2012; provided by Applicants) and in further view of Accessed 15/06/2021 (BLIS Probiotics product webpage. https://blisprobiotics.com.au/product/travelprotect-travel-immune-booster/ ; provided by Applicants). The teachings of Di Pierro and Kaci et al are set forth above. Additionally, Wescombe et al defines probiotic S	non patent literature	—	View ↗
each having strong anti-S. pyogenes inhibitory activity. Strain K12 has now been adopted by the New Zealand company BLIS Technologies Ltd (http://www.blis.co.nz) as the colonizing strain in a product, marketed as BLIS K12 Throat Guard (Fig	non patent literature	—	View ↗
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)	non patent literature	—	View ↗

Procedural framework (7)

Case lawCalifornia v. Eli Lilly·Ex Parte Simpson·Fires v. Revel·Genentech Inc. v. Novo Nordisk·In Re Lundak·See Brenner v. Manson·See Fiers v. Revel

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Claim status

Open 17/916,421 as a matter in your AI.

Prosecution history

All actions (2)

Notice of AllowanceLatest

Non-Final Office Action

Rejection groups (7)

Prior art consulted (3)