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 .
The response filed 1-5-2026 has been entered into the record.
Election/Restrictions
Applicant’s election of Group I (claims 1-21 and 24) and species of bacteria - Lactobacillus with traverse in the reply filed on 1-5-2026 is acknowledged. The traversal is on the ground(s) that the search for the species substantially overlaps and that the structure is the same. This is not found persuasive because as the species are classified differently and as such, the search for each one is independent from the other.
The requirement is still deemed proper and is therefore made FINAL.
Claims 22 and 23 are withdrawn from consideration.
Information Disclosure Statement
The information disclosure statement has been considered. An initialed copy is enclosed.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claim 1-21 and 24 are rejected under 35 U.S.C. 112(a), first paragraph, as failing to comply with the written description requirement. 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The claims recite “an inedible and dry dormant state encapsulated probiotic…” and broadly recite (1) a core which serves as nutrient source for probiotics (2) a first layer including dormant probiotics and a prebiotic as a food source for the probiotic surrounding the core (3) a polymer layer positioned over the first layer and (4) a dissolvable protective layer and kits comprising such with releasable mediums for dissolving the dissolvable layer and methods of making. The structure or component that correlates with “inedible” is not readily apparent from the recited structure. The structure that corresponds to the function of “inedible” is not set forth in the claims.
The specification provides written description of 11 different formulations of the single strain of Lactobacillus JCM1101 and teach that the components collectively contribute to the effectiveness of the core-shell particle in preserving and delivering probiotics (see specification pages 21-22, paragraph [0097]). It appears that only 5 of the formulations would be “inedible” having the presence of dipalmotyl hydroxylproline. The specification does not describe encapsulated core-shell formulations for combinations of probiotic species Bifidobacterium, Lactobacillus, Lactococcus, Leuconostoc, Streptococcus, Enterococcus, Staphylococcus, Saccharomyces, Kluyveromyces or Bifidobacterium, Lactococcus, Leuconostoc, Streptococcus, Enterococcus, Staphylococcus, Saccharomyces, Kluyveromyces spp alone.
The generically claimed structure does not per se define a structure that has the functional property of being inedible. The generic ingredients set forth in claims 2, 4, 6, 7, 8, 10 and 11 are generally recognized as save in low-level food additive applications. The only listed ingredient that cannot be consumed is dipalmitoyl hydroxyproline. A single inedible ingredient in the protective layer does not provide for a structure-function correlation of “inedible and dry dormant state encapsulate probiotic core-shell particle for external, non-mucosal site application” having additional broad functional language of the claims and does not demonstrate that Applicant was in possession of the scope of the inedible dormant sate encapsulated core-shell probiotic particles and kits comprising such.
In the instant application, the specification and claims draw a fence around a perceived genus but the genus is not adequately described. The specification exemplifies 5 specific core-shell particle formulations of Lactobacillus JCM1011 however, the claims are not limited to these structures and the structural variability of the claimed genus of particles is highly variant. No encapsulated core-shell formulations for combinations of probiotic species Bifidobacterium, Lactobacillus, Lactococcus, Leuconostoc, Streptococcus, Enterococcus, Staphylococcus, Saccharomyces, Kluyveromyces or Bifidobacterium, Lactococcus, Leuconostoc, Streptococcus, Enterococcus, Staphylococcus, Saccharomyces, Kluyveromyces spp alone have been disclosed. The particulars with respect to the other Genera are not disclosed and the art teaches that the effect of polymers on stability of freeze-dried (e.g. dormant) bacteria is influenced by species and no generalization of the effect of polymers could be reached. Champagne et al (Food Research International, 29(5-6):555-562, 1996; page 561, column 1, Conclusions). Sipailiene et al (Probiotics & Antimircro. Prot. 10:1-10, 2018) teach that probiotic encapsulation is an entire system that not only involves but also depends on many factors. Elements such as the encapsulation method itself, materials, environmental conditions and strain of probiotics all play an important role in the encapsulation process. The effect of the surface and structure of the capsules on the encapsulated microorganisms and the impact of materials used make a difference (see page 1, Abstract). Sipailiene et al teach that in spite of the numerous methods and materials being used for encapsulations, there are many difficulties related to microorganism viability during the process that have not been solved yet (see page 7, column 1, Conclusions). Given the limited formulations described and in view of the teachings of the art with regard to probiotic encapsulation it is apparent that there is no reasonable structure-function correlation which been established that is commensurate in scope with the claims. The specification does not describe representative examples to support the full scope of the claims.
Vas-Cath Inc. V. Mahurkar, 19 USPQ2d 1111, states that 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, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Thus, given the level of skill and knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed genus of inedible and dry dormant sate encapsulated probiotic core-shell particles for external non-mucosal skin application based on disclosures set forth above. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Applicant has not disclosed any relevant, identifying characteristics, such as structure or other physical and/or chemical properties, sufficient to show possession of the claimed genus. Mere idea or function is insufficient for written description; isolation and characterization at a minimum are required. A description of what a material does, rather than what it is, usually does not suffice. (Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406).
In the absence of sufficient recitation of distinguishing characteristics, the specification does not provide adequate written description of the claimed genus of particles which have the recited characteristics pointed out above. One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed (see Vas-Cath at page 1116). Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
Claims 1-21 and 24 are 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 or a joint inventor, or for pre-AIA the applicant regards as the invention.
As to claim 1 and all claims dependent thereon, the claims are confusing in that it is unclear if the dissolvable protective layer is part of the core-shell particle or an additional layer on top of it or in some other position (i.e. packaging) which functions has a dissolvable protective layer given that the preamble of the claim recites “encapsulated”. It is unclear where the dissolvable layer is positioned or is it a part of a package? Clarification is requested.
Claims Free of the Prior Art
The closest prior art is Sanchez-Portilla et al (J. Dairy Sci. 103:11129-11137, 2020) which teaches a Bifidobacterium probiotic layer over cores of microcrystalline cellulose or prebiotic-inulin as cores. The Bifidobacterum was grown, and the supernatant removed. The bacterial pellet was resuspended in a mixture containing skim milk and hydroxypropyl methylcellulose as a binder and physiological saline solution as a dispersion medium. The mixture was coated onto the granule cores until dry granules with bifidobacteria were obtained. Each product was further coated with an enteric polymer (page 11130, column 1, first and second paragraphs). The shell-core probiotics were intended for consumption and were “edible”. Additionally, the particles did not have a core plus 3-layer structure. WO 2008/0355322 also describes core-shell structures for edible probiotic microparticles for functional foods and nutraceuticals, liquid dietary supplements or dry power within capsules for oral administration (see page 1). Neither of these documents teach inedible probiotic microparticles having the claimed structure.
Other edible microencapsulated multi-layer probiotics are provided in the art for example US 2013/0323362; CN 207707285U; CN2013549547U; CN201798926U and US 10,111,835. However, each of these probiotic microparticles have the probiotic or probiotic containing matrix at the core of the particle and are edible.
The prior art does not fairly suggest “inedible and dry dormant sate encapsulated probiotic core-spell particles having a core structure for serving as a nutrient for the probiotic as claimed.”.
Conclusion
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/Patricia Duffy/Primary Examiner, Art Unit 1645
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