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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-6, 9-15, and 23 in the reply filed on 03/11/2026 is acknowledged. The traversal is on the grounds listed below. This is not found persuasive as follows:
(1) Applicant argues that the technical feature links the groups of claims to form a single general inventive concept under PCT Rule 13.1. This is not persuasive because, as explained in the Requirement for Restriction mailed 02/19/2026, the shared technical feature is not a special technical feature in view of Yonekura who discloses the technical feature (see also the obviousness rejection below). As such, the groups of inventions identified in the Restriction Requirement do not have unity of invention under PCT Rule 13.1 and 13.2.
(2) Applicant argues that the examiner has not shown “by appropriate explanation one of the following” citing several factors considered for restriction practice in applications filed under 35 USC 111 and citing MPEP 821.04. This is not persuasive because the instant case was filed under 35 USC 371, and the cited criteria and sections of the MPEP are not relevant to restriction practice under 35 USC 371. Please refer to MPEP 823:
The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a) (independent and distinct analysis). See MPEP Chapter 1800, in particular MPEP § 1850, § 1875, and § 1893.03(d), for a detailed discussion of unity of invention under the Patent Cooperation Treaty (PCT).
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/11/2026.
Claims 1-6, 9-15, and 23 are under current examination.
Information Disclosure Statement
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.
Specification
Content of Specification
The specification lacks a heading for the brief description of the drawings.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S): See MPEP § 608.01(f). A reference to and brief description of the drawing(s) as set forth in 37 CFR 1.74.
Claim Objections
Claim 13 is objected to because of the following informalities: Claim 13 recites “with one of the following compositions”. The examiner recommends amending the claim to recite “wherein the composition comprises”. Appropriate correction is required.
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 2, 4, 10, 14, and 15 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.
Regarding claim 2, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 4, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The term “approximate” in claim 10 is a relative term which renders the claim indefinite. The term “approximate” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As such the ratio of the recited monomers is indefinite and the scope of the claim is unclear. The examiner notes that the specification provides the following guidance: The terms “about”, “approximately”, “substantially” must be read with reference to the context of the application as a whole, and have regard to the meaning a particular technical term qualified by such a word usually has in the field concerned. For example, it may be understood that a certain parameter, function, effect, or result can be performed or obtained within a certain tolerance, and the skilled person in the relevant technical field knows how to obtain the tolerance of such term. However, this does not provide the type of limiting definition that would resolve the indefiniteness concern in this case.
Claim 14 recites the limitation "the particles" in lines 3 and 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 15, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1-5, 9-12, 14, 15, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180119088; publication date: 03/03/2018).
With regard to claim 1, Wang discloses a microparticle formed by spray drying and containing a probiotic bacteria (abstract). The probiotic bacteria comprises one or more Lactobacillus species (0007). The particle may further comprise a prebiotic such as sugars, oligosaccharides, and polysaccharides including maltodextrin, inulin, and trehalose (0045). The particle also contains an encapsulating substance such as alginate and/or whey protein (0040). Although Wang’s example microparticles do not contain a prebiotic and are coated with ether caseinate or a caseinate-gum Arabic mixture, the broader teachings of Wang embrace a spray-dried composition comprising Lactobacillus probiotic; oligosaccharide, polysaccharide or protein; and alginic acid (i.e. alginate).
With regard to the limitations on percentages of probiotic, prebiotic, and coating material recited in instant claims 1 and 2, Wang does not describe the amount of the ingredients in the microparticle in terms of their percent by weight relative to the total weight of the microparticle composition but rather provides ratios of encapsulating material to other ingredients in the microparticle (particularly, a low melting point fat; 0042) and describes the quantity of probiotic in terms of CFU per mL added when combining ingredients to the solution that will be spray dried in examples (0059). This would have given the artisan of ordinary skill a starting point to optimize the handful of ingredients used to form the microparticle, and for this reason the examiner does not consider the percentages of probiotic, prebiotic, and coating material required by the instant claims to patentably define over the cited prior art. Please refer to MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to claims 3 and 4, as noted above, Wang teaches including the prebiotics maltodextrin, inulin, and trehalose. The examiner notes that the encapsulating material also includes the prebiotic whey protein, thus it also would have been prima facie obvious to include this material in the microparticle.
With regard to claim 5, as discussed supra the genus is Lactobacillus.
With regard to claims 9 and 10, these claims limit the identity of the polymer of acrylic acid and/or acrylates if present; however, as these claims are currently worded they do not require the presence of the recited polymers in the event that the spray-dried composition contains any of the other coating materials. As Wang’s microparticles contain alginate, these claims read on Wang’s spray-dried microparticles exactly as described for claim 1.
With regard to claim 11, Wang discloses mixtures (i.e. at least two different) of the materials for encapsulation (0040).
With regard to claim 12, as detailed above, the prebiotics disclosed by Wang are different from the encapsulating materials.
With regard to claim 14, the particles have a smooth, dimpled appearance (Fig 2C, drawing sheet 1; 0069).
With regard to claim 15, Wang discloses an example composition having 0.18 or 0.19 and 0.20 water activity (0092) and provides the teaching that a water activity between 0.11 and 0.23 can prevent cell death during storage, while water activity above this range is related to accelerated mortality of probiotics (0093). Thus, it would have been obvious to formulate the microparticles such that their water activity was between 0.11 and 0.23, which falls within the scope of instant claim 15.
With regard to claim 23, Wang discloses adding probiotics to food (0002), and thus it would have been prima facie obvious to do so.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180119088; publication date: 03/03/2018) as applied to claims 1-5, 9-12, 14, 15, and 23 above, and further in view of Espadaler Mazo et al. (US 20160193260; publication date: 07/07/2016).
The relevant disclosure of Wang is set forth above. Wang does not disclose Lacticaseibacillus rhamnosus GG.
Espadaler Mazo discloses that L. rhamnosus GG was a well-known probiotic (Fig 3) as of the instant effective filing date.
It would have been prima facie obvious to use L. rhamnosus GG as a probiotic in Wang’s spray dried microparticles because it was known for the same purpose as the probiotics disclosed by Wang. See MPEP 2144.06.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (US 20180119088; publication date: 03/03/2018) and Espadaler Mazo et al. (US 20160193260; publication date: 07/07/2016) as applied to claims 1-6 9-12, 14, 15, and 23 above, and further in view of Knutsen et al. (US 20110104239; publication date: 05/05/2011) and Li et al. (US 20200236977; publication date: 07/30/2020).
The relevant disclosures of Wang and Espadaler Mazo are set forth above and render obvious a spray dried microparticle containing the probiotic Lacticaseibacillus rhamnosus GG, alginic acid as a coating material, and a prebiotic in percentages that would have been optimizable as a matter of routine for one of ordinary skill at the time the instant invention was filed. Wang and Espadaler Mazo do not disclose a shellac coating or soluble soybean polysaccharides as a prebiotic.
Knutsen, in the analogous art of probiotic-containing edible products (title: probiotic chewing gum) teaches that shellac is a moisture resistant barrier (0059).
Li teaches that soluble soybean polysaccharide is a known prebiotic (0025).
It would have been prima facie obvious to add shellac to the encapsulation materials disclosed by Wang. The artisan of ordinary skill would have been motivated to include shellac in the encapsulation material as a means to adjust moisture in the particle. As discussed above, Wang discloses optimizing water activity for probiotic viability in the particle. Including a moisture resistant barrier in the encapsulation material would aid in preventing undesirable moisture loss or absorption. The skilled artisan would have had reasonable expectation of success because shellac was known as of the instant effective filing date to be a useful coating to protect prebiotics.
It would have been prima facie obvious to use soluble soy polysaccharide as the prebiotic in Wang’s spray dried particles because this substance was known to serve the same purpose as of the instant effective filing date. See MPEP 2144.06.
With regard to the percentages of each component of the claimed spray-dried composition, as explained above, Wang does not describe the amount of the ingredients in the microparticle in terms of their percent by weight relative to the total weight of the microparticle composition but rather provides ratios of encapsulating material to other ingredients in the microparticle (particularly, a low melting point fat; 0042) and describes the quantity of probiotic in terms of CFU per mL added when combining ingredients to the solution that will be spray dried in examples (0059). This would have given the artisan of ordinary skill a starting point to optimize the handful of ingredients used to form the microparticle, and for this reason the examiner does not consider the percentages of probiotic, prebiotic, and coating material required by the instant claims to patentably define over the cited prior art. Please refer to MPEP 2144.05(II)(A): Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617