DETAILED ACTION
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 .
Amendments
Claims 1, 6, and 12-13 have had minor typographic changes.
Claim 1 now allows for the phosphate salt to comprise “mixtures thereof”.
Claim Status
Claims 1-6 and 8-20 are currently pending and have been examined on their merits.
Specification
Previous objections to the specification
The specification was objected to for minor typographic errors. Applicant has made the appropriate correction and the objection is therefore withdrawn.
Claim Objections
Previous objections to the claims
Claims 6 and 12-13 were previously objected to for minor informalities. Applicant has made the appropriate correction and the objections are therefore withdrawn.
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.
Previous rejection under 35 U.S.C. § 112
RE: Rejection of claim 13 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claim 13 was rejected under 35 U.S.C. § 112(b) because it recited Lactobacillus reuteri Protectis® and Lactobacillus reuteri Prodentis®.
Applicant asserts that claim 13 has been amended such that all trademarked terms are properly denoted.
Applicant’s arguments have been fully considered but are not sufficient to overcome the rejection of record for the following reason.
Lactobacillus reuteri Prodentis® is not a single strain of Lactobacillus reuteri but is instead a marketed and trademarked product. For example, BioGaia (“Meet L. reuteri DSM 17938”, BioGaia, https://www.biogaia.com/pages/meet-l-reuteri, Webpage. Accessed October 2026) teaches that L. reuteri Protectis® contains DSM 17938 and L. reuteri Prodentis® is a product which contains L. reuteri DSM 179381 and ATCC PTA 5289 (p. 3, par. 2). Thus, the Prodentis® and Protectis® terms are not strain names but are instead descriptive of a marketed product including a product which comprises a plurality of strains.
As discussed in the rejection of record, if the trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of the 35 U.S.C. 112(b). Therefore, because the claim recites a tradename rather than the actual strains contained in the trademarked product, the claim is indefinite and the rejection must be maintained.
Maintained rejection under 35 U.S.C. § 112
Claim 13 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor regards as the invention.
Claim 13 contains the trademark/trade names Lactobacillus reuteri Protectis® and Lactobacillus reuteri Prodentis®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982).
The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe particular strains (i.e., goods themselves) and, accordingly, the identification/description is indefinite.
In the interest of compact prosecution, it is recommended that the limitations be deleted because the claim already encompasses every Lactobacillus reuteri strain. Alternatively, the claim may be amended to recite particular biological deposits made of these strains.
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.
Previous rejection under 35 U.S.C. § 103
RE: Rejection of claims 1-6 and 8-20 under 35 U.S.C. 103 as being unpatentable over Mazeaud et al. (WO 2011/018509 A1; cited in IDS filed on 04/10/2025).
Applicant traverses the rejection of record by arguing that the structure of the claimed composition is different from the structure of the composition described by Mazeaud. Specifically, the composition of the instantly pending claims comprises a blend of the dried microorganism and the salt (the salt being in powder form) and in contrast the composition as described in Mazeaud is a dried microorganism with a salt coating.
To substantiate this argument, applicant cites p. 33, line 12 of Mazeaud which teaches “[t]he coated dehydrated microorganism of the present invention can be used as an ingredient in the preparation of foods selected from the group comprising…beverages such as powders”. Therefore, because Mazeaud contemplates the use of a coated microorganism in a powdered form, it allegedly does not teach a microorganism blended with a salt powder.
For this reason, applicant argues that the claims are being misinterpreted as simply requiring an overall powder composition rather than a microorganism “blended” with a salt powder. Applicant argues that although Mazeaud also teaches increased viability and stability, the blend of the instant claims is advantageous because it “can be made far more inexpensively and easily” such as in a simple mixer (p. 8, par. 3).
Applicant’s arguments have been fully considered but are not sufficient to overcome the rejection of record for the following reasons.
First, with respect to the term “blend” as used in the claims. Under a broadest reasonable interpretation (BRI), words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. The plain meaning of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. (MPEP § 2111.01(I)). The plain meaning of a “blend” is a mixture or combination of things that is useful or pleasant (Collins Dictionary, “Blend”, https://www.collinsdictionary.com/us/dictionary/english/blend. Accessed October 2026). Thus, the broadest reasonable interpretation of the claim’s use of “blend” is a mixture or combination of a dried microorganism and a phosphate salt in powder form.
As discussed in the rejection of record, Mazeaud teaches a coated dehydrated (i.e., dried microorganism) which can be preferably in the form of a powder (p. 33, par. 2). Mazeaud’s composition is not merely a dried microorganism with a small, coated layer of powdered hygroscopic salt (such as by coating a surface) because Mazeaud’s composition is provided as a powder and can contain at least 25% by weight of the hygroscopic salt. Thus, when formulated as a powder (Mazeaud’s preferred formulation), the composition clearly contains a substantial amount of powdered hygroscopic salt interspersed with dried microorganisms rather than a discrete layer of hygroscopic salt on each individual microorganism. This is sufficient to meet the “blend” term.
Additionally, Mazeaud’s explicit definition of “coating” is broad and means “any layer (or coating layer) surrounding the dehydrated microorganism once the liquid coating composition is applied and dried” (p. 5, lines 13-15). Thus, when formulated as a powder (i.e., after drying) Mazeaud clearly teaches a “blend” of dried microorganism and a powdered hygroscopic salt because the overall form of the composition is a powder and the hygroscopic salt is interspersed with the dried microorganism.
For at least these reasons, the rejection of record is proper and has been maintained.
In the interest of compact prosecution, assuming arguendo that Mazeaud does not meet the plain meaning of “blend”, the difference between the instantly claimed composition and Mazeaud’s invention merely amounts to rearranging how the hygroscopic salt is provided to the dried microorganism. Mazeaud’s invention would involve supplying a dried a microorganism, spray drying with hygroscopic salt, and converting the entire composition to a powder (i.e., a mixture of a dried microorganism and a powdered hygroscopic salt); while the instant invention would involve providing a dried microorganism and providing a powdered hygroscopic salt. And although this difference may omit the step of spray drying, it nonetheless is predicated on the principles disclosed in Mazeaud; namely, that combining a hygroscopic salt with a dried microorganism improves the stability and activity of the microorganism.
Maintained rejection under 35 U.S.C. § 103
Claims 1-6 and 8-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mazeaud et al. (WO 2011/018509 A1; cited in IDS filed on 04/10/2025).
Mazeaud et al. (hereinafter Mazeaud) teaches coated dehydrated microorganisms having enhanced stability and viability (p. 1, lines 5-6). Specifically, Mazeaud teaches that the addition of a hygroscopic salt layer surrounding dehydrated microorganisms surprisingly enhances the survival rate especially in high humidity and/or high temperature conditions (p. 3, lines 3-11).
Regarding claim 1, Mazeaud teaches a coated dehydrated microorganism comprising a dehydrated (i.e., dried) microorganism and a hygroscopic salt (p. 3, lines 13-20). Mazeaud teaches that the hygroscopic salt can be dipotassium phosphate (K2HPO4) or disodium hydrogen phosphate (Na2HPO4)(p. 8, lines 1-11). Additionally, the composition can also comprise at least one non-hygroscopic salt which includes monopotassium phosphate (KH2PO4)(p. 3, lines 3-11; p. 9, lines 15-21). Mazeaud’s composition includes salts in the powder form because it teaches that the composition can be provided as a powder (p. 33, lines 12-26). Finally, Mazeaud’s hygroscopic salt is in an amount of at least 25% and non-hygroscopic salt is in an amount of 0 to 60% (p. 3, lines 3-11). This range overlaps with the range of “at least 50 wt% based on the total weight of microorganism and phosphate salt”. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Accordingly, Mazeaud makes obvious the composition of claim 1.
Regarding claim 2, as discussed above, Mazeaud makes obvious a composition comprising K2HPO4 and/or KH2PO4 (p. 3, lines 3-11; p. 8, lines 1-11; p. 9, lines 15-21).
Regarding claim 3, as discussed above, Mazeaud makes obvious a composition comprising disodium hydrogen phosphate (Na2HPO4)(p. 8, lines 1-11).
Regarding claim 4, as discussed above, Mazeaud makes obvious a composition comprising K2HPO4 and KH2PO4 (p. 3, lines 3-11; p. 8, lines 1-11; p. 9, lines 15-21). These are salts of HPO42- and H2PO4-.
Regarding claims 5-6, as discussed above, Mazeaud makes obvious the composition of claim 1. Mazeaud further teaches that the pH of the coating should be compatible with viability of the coated dehydrated microorganism and this usually means between 5.5 and 7.9, preferably between 6 and 7.5 (p. 9, lines 24-29). Accordingly, Mazeaud teaches a pH range which overlaps with the instantly claimed ranges of between pH 6 and 9 and between pH 6.8 and 7.2. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Regarding claims 8-9, as discussed above, Mazeaud makes obvious the composition of claim 1 including a hygroscopic salt in an amount of at least 25% and non-hygroscopic salt is in an amount of 0 to 60% (p. 3, lines 3-11). The range of “at least 25%” overlaps with the instantly claimed ranges of at least 60 wt% and at least 80 wt%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP § 2144.05(I)).
Regarding claim 10, as discussed above, Mazeaud makes obvious the composition of claim 1. Mazeaud teaches that the dehydrated microorganisms can be obtained by conventional methods such as freeze-drying (p. 25, lines 26-28; p. 30, lines 28-29).
Regarding claim 11, as discussed above, Mazeaud makes obvious the composition of claim 1. Mazeaud teaches that the microorganisms are typically probiotics (p. 26, lines 7-13).
Regarding claim 12, as discussed above, Mazeaud makes obvious the composition of claim 1. Mazeaud teaches that the microorganisms can be from the genera Lactobacillus, Bifidobacterium, or Saccharomyces (p. 25, lines 4-13).
Regarding claims 13-14, as discussed above, Mazeaud makes obvious the composition of claim 1. Mazeaud teaches that typically the microorganisms are Lactobacillus acidophilus or Lactobacillus plantarum (p. 25, lines 14-21).
Regarding claim 15, as discussed above, Mazeaud makes obvious the composition of claim 1. Mazeaud teaches that the composition can be a consumer healthcare product, a dietary supplement, a nutraceutical, an over-the-counter product, or an agri-product (p. 34, line 27 through p. 35, line 18). These are considered to be forms of unit microbial dose. This position is supported by applicant’s specification which teaches that the unit microbial dose may be a sachet, capsule, or tablet (p. 10, lines 7-11). Mazeaud teaches that the above products can be capsules or tablets (p. 35, lines 20-25).
Regarding claims 16 and 18, as discussed above, Mazeaud teaches that the composition may be in the form of a capsule or tablet (Id.).
Regarding claim 17, as discussed above, Mazeaud makes obvious the composition of claim 1 including in a unit microbial dose.
Mazeaud teaches many working examples wherein samples comprising a powdered L. acidophilus NCFM and phosphate salt were introduced into hermetically sealed sachets (p. 40-43; Table 1; Samples 10-12, 15-20, 22-24, and 26-28). See Examples 3, 8, and 15. Mazeaud also teaches that the composition can be stored in a hermetic sachet (p. 31, line 29 through p. 32, line 3). As such, Mazeaud renders obvious a unit microbial dose in the form of a sachet containing the composition.
Regarding claim 19, as discussed above, Mazeaud makes obvious the composition of claim 1 including in a unit microbial dose.
Mazeaud teaches that the powdered microorganisms can be preferably in an infant formula (i.e., a nutritional formula)(p. 33, lines 12-26). Additionally, Mazeaud gives working examples wherein the product was added to SlimFast® powder and Good Sense Gentle Plus instant baby formula (Examples 8 and 15). As such, Mazeaud renders obvious the composition in the form of a powdered nutritional formula.
Regarding claim 20, as discussed above, Mazeaud teaches the generation of samples comprising dried microorganism and phosphate salt. Mazeaud provides examples wherein the microorganism and phosphate salt were mixed to prepare a composition comprising dried microorganisms and phosphate salt. For example, Example 8 teaches that the compositions of samples 11, 17, and 18 (i.e., dried L. acidophilus NCFM + phosphate salt) were blended (i.e., mixed) to provide a composition comprising each of the elements. Table 1 demonstrates that the salts were present in an amount of at least 50 wt% (69%). Accordingly, Mazeaud renders obvious a process for the preparation of the composition of claim 1 comprising providing dried microorganism and phosphate salt in powder form and mixing the dried microorganisms and the phosphate salt to provide the composition.
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 GRANT C CURRENS whose telephone number is (571)272-0053. The examiner can normally be reached Monday - Thursday: 7:00-5:00.
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, Melenie Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GRANT C CURRENS/Examiner, Art Unit 1651
/MELENIE L GORDON/Supervisory Patent Examiner, Art Unit 1651
