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
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 2-19-2026 is acknowledged. The traversal is on the ground(s) that both Group I and Group II recite sprayable compositions comprising powdered viable non- sporulating bacteria particles suspended in an anhydrous liquid carrier, wherein at least 90 % of the powdered bacteria particles have a particle size of less than 400 µm and these features are not disclosed in the references cited in the written opinion. This is not found persuasive because as evidenced by the art rejections set forth below (which are predicated on the references cited in the Written Opinion), the claimed invention does not make a contribution to the art. Therefore, unity of invention is lacking.
The requirement is still deemed proper and is therefore made FINAL.
Claims 30-49 are pending. Claims 45-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 30-44 are currently under examination.
Information Disclosure Statement
The Information Disclosure Statement filed on 4-11-2024 has been considered. An initialed is attached hereto.
It should be noted that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
Claims 30-44 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.
Claim 30 is rendered vague and indefinite by the use of the phase “…composition is formulated as a liquid spray.”. It is unclear what is meant to be engendered by said phrase as the composition comprises a liquid carrier and therefor would necessarily be sprayable. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 31 is rendered vague and indefinite by the use of the phrase “… the composition lacks a propellant gas.”. It is unclear what is meant to be engendered by said phrase as the composition is under ambient pressure and therefor could not comprise a propellant gas. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 34 is rendered vague and indefinite by the use of the phrase “…wherein the powdered bacteria particles are present in the suspension…”. It is unclear what is meant to be engendered by said phrase as the “powdered bacteria” would no longer be in powdered form once it is added to the liquid carrier. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim 41 is rendered vague and indefinite by the use of the phrase “…is formulated as an oronasopharyngeal spray or as a topical dermatological spray.”. It is unclear what is meant to be engendered by said phrase. What additional elements must be present for the liquid spray of the independent claim to be an oronasopharyngeal spray or a topical dermatological spray given the spray of the independent claim can administered oronasopharyngeally or topically to the skin. As written, it is impossible to determine the metes and bounds of the claimed invention.
Claim Rejections - 35 USC § 102
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 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.
Claims 30-33 and 35-42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gehrman et al. (U.S. Patent 4,518,696 – IDS filed on 4-11-2024).
Gherman et al. disclose stabilized liquid suspensions comprising Lactobacilli and sunflower seed oil (see abstract). Gherman et al. further disclose that sunflower oil is anhydrous and contains large amounts of unsaturated fats and triglycerides (see column 2, line 65 to column 3, line 2); that said compositions can further comprise fumed silica and other stabilizers (see abstract and column 2, lines 63-68); that the fumed silica is present at between about 0.5 and 2.0% based on weight (see column 3, lines 48-50); that the Lactobacillus species can be Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus lactis, Lactobacillus, bifidus, Lactobacillus bulgaricus, Lactobacillus helveticus or Lactobacillus casei (see column 2, lines 10-12); and that the Lactobacillus can be present at about 4% wt.% of the composition (see Example I for example). Consequently, Gherman et al. anticipates all the limitations of the rejected claims.
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.
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.
Claims 30-44 are rejected under 35 U.S.C. 103 as being unpatentable over Gehrman et al. (U.S. Patent 4,518,696 – IDS filed on 4-11-2024) and Henkens et al. (WO 2018/078067 – IDS filed on 4-11-2024).
Gherman et al. disclose stabilized liquid suspensions comprising Lactobacilli and sunflower seed oil (see abstract). Gherman et al. further disclose that sunflower oil is anhydrous and contains large amounts of unsaturated fats and triglycerides (see column 2, line 65 to column 3, line 2); that said compositions can further comprise fumed silica and other stabilizers (see abstract and column 2, lines 63-68); that the fumed silica is present at between about 0.5 and 2.0% based on weight (see column 3, lines 48-50); that the Lactobacillus species can be Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus lactis, Lactobacillus, bifidus, Lactobacillus bulgaricus, Lactobacillus helveticus or Lactobacillus casei (see column 2, lines 10-12); and that the Lactobacillus can be present at about 4% wt.% of the composition (see Example I for example).
Gherman et al. differs from the rejected claims in that they don’t explicitly disclose the use of epicatechins, quinones, creatin, hydroxytyrosol, pyridoxamine, cysteine, homocysteine, or glutathione as formulation stabilizers.
Henkens et al. disclose the sprayable bacterial formulations comprising lactobacilli, anti-sedimentation agents and antioxidants (see page 9, lines 5-28).
Consequently, Henkens et al. demonstrate that the use of antioxidants in “bacterial sprays” was known at the time of the instant invention, it would have been obvious for the skilled artisan to utilize them in the compositions of Gherman et al.
With regard to the specific formulations set forth in claim 44, the KSR decision sets forth “if a technique has been used to improve one device, and a person of skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill”. Given that both Gherman et al. and Henkens et al. dislose the use of formulation stabilizers in their compositions and the various types of formulation stabilizers are well established in the art, the use of the specific formulation stabilizers recited in claim 44, is well within the capabilities of one of ordinary skill in the art. Hence, the requirements of obviousness under the KSR decision are met. The same is true for the use of the specific antioxidants recited in claim 43.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT A ZEMAN whose telephone number is (571)272-0866. The examiner can normally be reached Monday thru Friday; 6:30 am - 3pm EST.
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/ROBERT A ZEMAN/ Primary Examiner, Art Unit 1645 June 6, 2026
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