DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Preliminary Amendment
1) Acknowledgment is made of Applicants’ preliminary amendment filed 01/09/23.
Election
2) Acknowledgment is made of Applicants’ election filed 12/16/25 in response to the restriction and the species election requirement mailed 10/21/25. Applicants have elected, without traverse, invention I, and the Lactobacillus plantarum probiotic microorganism species, the limestone calcium carbonate species, the phosphoric acid H3O+ ion donor species, the shelf live preservative stabilizing agent species, and the nutritional stabilized probiotic composition species.
Status of Claims
3) Claims 1-11 and 13-15 have been amended via the preliminary amendment filed 01/09/2023.
New claim 16 has been added via the preliminary amendment filed 01/09/23.
Claims 1-16 are pending.
Claims 11-15 are withdrawn from consideration as being directed to a non-elected invention. See 37 C.F.R 1.142(b) and M.P.E.P § 821.03.
Claims 1-10 and 16 are examined on the merits.
Drawings
4) Acknowledgment is made of Applicants’ drawings filed 01/09/2023.
Information Disclosure Statement
5) Acknowledgment is made of Applicants’ information disclosure statement filed 01/09/23. The information referred to therein has been considered and a signed copy of the same is attached to this Office Action.
Priority
6) The instant AIA application, filed 01/09/2023, is the national stage 371 application of PCT/EP2021/070233 filed 07/20/21, which claims priority to the European application 20186782.7 filed 07/20/2020. It is noted that a certified copy of the foreign priority application is of record.
Objection(s) to Specification
7) The specification is objected to for the following reason(s):
(I) The instant application is informal in the format or arrangement of the
specification. The following guidelines illustrate the preferred layout and content for patent
applications. These guidelines are suggested for the Applicants’ use.
Content of Specification
(a) Title of the Invention: See 37 C.F.R 1.72(a). The title of the invention should be placed at the top of the first page of the specification. It should be brief but technically accurate and descriptive, preferably from two to seven words.
(b) Cross-References to Related Applications: See 37 C.F.R 1.78 and M.P.E.P § 201.11.
(c) Statement Regarding Federally Sponsored Research and Development: See M.P.E.P § 310.
(d) Reference to a “Microfiche Appendix”: See 37 C.F.R 1.96(c) and M.P.E.P § 608.05. The total number of microfiche and the total number frames should be specified.
(e) Background of the Invention: The specification should set forth the Background of the Invention in two parts:
(1) Field of the Invention: A statement of the field of art to which the invention pertains. This statement may include a paraphrasing of the applicable U.S. patent classification definitions of the subject matter of the claimed invention. This item may also be titled "Technical Field."
(2) Description of the Related Art: A description of the related art known to the applicant and including, if applicable, references to specific related art and problems involved in the prior art which are solved by the applicant's invention. This item may also be titled "Background Art."
(f) Brief Summary of the Invention: A brief summary or general statement of the invention as set forth in 37 C.F.R 1.73. The summary is separate and distinct from the abstract and is directed toward the invention rather than the disclosure as a whole. The summary may point out the advantages of the invention or how it solves problems previously existent in the prior art (and preferably indicated in the Background of the Invention). In chemical cases it should point out in general terms the utility of the invention. If possible, the nature and gist of the invention or the inventive concept should be set forth. Objects of the invention should be treated briefly and only to the extent that they contribute to an understanding of the invention.
(g) Brief Description of the Several Views of the Drawing(s): A reference to and brief description of the drawing(s) as set forth in 37 C.F.R 1.74. The recitation ‘Figure Legends’ on page 9 of the specification should be replaced with --Brief Description of the Drawings’--.
(h) Detailed Description of the Invention: A description of the preferred embodiment(s) of the invention as required in 37 C.F.R 1.71. The description should be as short and specific as is necessary to describe the invention adequately and accurately. This item may also be titled "Best Mode for Carrying Out the Invention." Where elements or groups of elements, compounds, and processes, which are conventional and generally widely known in the field of the invention described and their exact nature or type is not necessary for an understanding and use of the invention by a person skilled in the art, they should not be described in detail. However, where particularly complicated subject matter is involved or where the elements, compounds, or processes may not be commonly or widely known in the field, the specification should refer to another patent or readily available publication which adequately describes the subject matter.
(i) Claim or Claims: See 37 C.F.R 1.75 and M.P.E.P § 608.01(m). The claim or claims must commence on separate sheet. (37 C.F.R 1.52(b)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps.
(j) Abstract of the Disclosure: A brief narrative of the disclosure as a whole in a single paragraph of 250 words or less on a separate sheet following the claims.
(k) Drawings: See 37 C.F.R 1.81, 1.83-1.85, and M.P.E.P § 608.02.
(l) Sequence Listing: See 37 C.F.R 1.821-1.825.
(II) All non-italicized recitations of the names of the bacteria in the first full paragraph of page 21 of the specification are objected to. To be consistent with the practice in the art of bacterial nomenclature, it is suggested that Applicants delete said limitations via strikethrough, for example, i.e., Lactobacillus casei and replace it with the underlined limitation –Lactobacillus casei--.
Rejection(s) under 35 U.S.C § 112(a) or (Pre-AIA ) First Paragraph
8) The following is a quotation 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 (pre-AIA ), first paragraph:
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 of carrying out the invention.
9) Claims 1-10 and 16 are rejected under 35 U.S.C § 112(a) or 35 U.S.C § 112 (pre-AIA ), first paragraph, as containing 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 the pre-AIA the Applicants, at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The purpose of the written description requirement is ‘to ensure that the inventor had possession, as of the filing date of the application relied on, of the specific subject matter later claimed by him.’ In re Edwards, 568 F.2d 1349, 1351-52, 196 USPQ 465, 467 (CCPA 1978). The analysis of whether the as-filed specification complies with the written description requirements calls for the Office to compare the scope of the claims with the scope of the description to determine whether Applicants have demonstrated possession of the full scope of the claimed invention at the time of the invention. In the instant application, an analysis of the scope of the claims and of the large genus encompassed therein indicates the following.
Claim 1 is representative of the claimed product. Claim 1 is drawn to a stabilized probiotic composition comprising a stabilizing agent comprising a surface-reacted calcium carbonate (SRCC) and a probiotic microorganism culture, wherein the surface-reacted calcium carbonate or a precipitated calcium carbonate with carbon dioxide and one or more H3O+ ion donors, wherein the carbon dioxide is formed in situ by the H3O+ ion donors treatment and/or is supplied from an external source. The limitation “a probiotic microorganism ...” represents a humongous genus encompassing genetically, taxonomically and antigenically divergent bacterial and fungal probiotic species. Likewise, the limitation “a surface-reacted calcium carbonate” represents a large genus encompassing structurally divergent species including those not having a volume median particle size d50 range, a volume top cut particle size d98 range, a specific surface area in the specific range, and an intra-particle intruded specific pore volume range as claimed in claim 5. Likewise, the precipitated calcium carbonate and the one or more H3O+ ion donors and the H2PO4- and HPO42 represent a large genus encompassing numerous structurally divergent species. Only claim 7 requires the probiotic microorganism culture to the SRCC weight ratio to be in a specific weight ratio range. The divergent members or species of said genus are required to contribute to the stabilization of the claimed probiotic composition, i.e., the structure of the divergent species is required to be correlated with the stabilizing function. However, a review of the instant specification indicates that at the time of the invention, Applicants were not in possession of the full scope of each of said genus and of the full scope of the invention as claimed.
The written description requirement can be met by describing the claimed subject matter to a person skilled in the art using sufficiently detailed, relevant identifying characteristics such as functional characteristics, and correlating those functional characteristics with a disclosed structure. See Enzo Biochem v. Gen-Probe, 323 F.3d 956, 964, 967, 968 (Fed. Cir. 2002). Sufficient description to show possession of a genus may be achieved by means of description of a substantial number of the members or species of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would allow the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicants have possession the claimed invention. Applicants have not described a sufficient number and variety of the divergent species contributing to the requisite stabilizing function. A representative number and variety of the species within the claimed broad genus have not been correlated with the requisite stabilizing function. Note that possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features. Applicants should further note that written description requires more than a mere statement that something is a part of the invention and a reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. A mere statement that the invention includes the elements recited in the claims is insufficient to meet the adequate written description requirement of the claimed invention. A convincing structure-function relationship must exist between the structure of a representative number and variety of the various elements and the function(s) of the elements.
The written description inquiry is case-specific and context-specific. It “depend[s] on the nature of the claimed invention and the knowledge of one skilled in the art at the time an invention is made and a patent application is filed.” Ariad, 560 at 1372. A number of factors guide the inquiry, including “the existing knowledge in the particular field, the extent and content of the prior art, the maturity of the science or technology, and the predictability of the aspect at issue.” Ariad, 560 at 1372 [Emphasis added]. According to MPEP 2163 [Emphasis added]:
The description needed to satisfy the requirements of (pre-AIA ) 35 U.S.C § 112 “varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence.” Capon v. Eshhar, 418 F.3d at 1357, 76 USPQ2d at 1084. Patents and printed publications in the art should be relied upon to determine whether an art is mature and what the level of knowledge and skill is in the art.
Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable arts. This is important in the instant application because the art recognizes that probiotics can face challenges in terms of stability during food processing, storage, and gastrointestinal digestion. See 1st sentence of Abstract of Mudgil et al. Front. Sustain. Food Syst. 29 Feb 2024. Furthermore, Payne JE (Evaluation of the Stability and Viability of Various Bacillus strains as Probiotics. Submitted for Ph.D. degree, pages 1-182, May 2024) taught the following with regard to the difficulty in maintaining the viability, stability, and functionality of probiotic microorganisms during processing and storage. See pages 58 and 20.
The most common probiotics, such as Lactobacillus are often susceptible to food processing conditions. ........ the stability of Bacillus in food matrices is unknown. The survivability of a probiotic is difficult to predict because it is not simply a function of temperature; it is a complex interaction between the food matrix, the process conditions, and the microbial strain”
2.3 Stability of Probiotics. Creating functional foods, while maintaining the viability and functionality of probiotic microorganisms during processing and storage in many food products, is difficult. Further, the survivability of a probiotic is difficult to predict because it is not simply a function of temperature; it is a complex interaction between the food matrix, the process conditions, and the microbial strain. It has been noted that the stability, safety, and effectiveness of a probiotic are strain-specific and not due to the species or genus. In literature, many variables can affect the development of functional foods with probiotics. Seven main characteristics or variables are the most important when developing these food products: (1) type of probiotic; (2) amount of probiotic to be added; (3) water activity of the product; (4) viability of probiotic during processing; (5) determination of the cell populations added; (6) storage stability; and (7) sensory acceptability (Champagne, Gardner, and Roy, 2005). Other characteristics such as the food matrix and oxygen content can also affect the viability of probiotic microorganisms. In many of the new food products being proposed as carriers for probiotics, there is little knowledge of the stability and longevity of the probiotic cultures within the food matrix, storage conditions, processing, and how it affects the sensory characteristics of the products.
The art further recognizes the strain-specificity and functional unpredictability associated with diverse probiotics. For example, Gao et al. (Peer J. 7: e7117, pages 1/24-24/24, 2019) taught that the probiotic effects are dependent on the nature of the strain by stating that “.... the efficacy ..... varies, depending on the types and strains of probiotics”. See third paragraph on page 2 of Gao et al. See also title; the 3rd full sentence of 1st full paragraph. All these clearly indicate that not all species and strains of bacterial and non-bacterial probiotics encompassed within the broad scope of the recited probiotic microorganism genus can be predicted to remain optimally stable and/or viable in the claimed composition such that they can be used for the intended pharmaceutical, cosmetic and nutritional purposes. Clearly, at the time of the invention, other than a stabilized probiotic composition comprising a specific CFU concentration of the live Lactobacillus plantarum WCFS1 and a specific SRCC suspension of ground limestone obtained as described in Examples, wherein the live Lactobacillus plantarum WCFS1 and the SRCC having a specific volume median particle size d50, a specific volume top cut particle size d98, a specific surface area, and a specific intra-particle intruded specific pore volume as described in Examples, wherein the probiotic composition showed a higher viability compared to a corresponding probiotic composition comprising maltodextrin as a stabilizing agent, Applicants were not in possession of the full scope of the entire probiotic microorganism genus, the SRCC stabilizing agent genus, and of the full scope of the composition as claimed broadly. The viability results and the CFU values from each of the spray drying test, in-vitro digestion testing, and shelf-life testing in the as-filed specification are limited to composition samples comprising a specific wt-% of specific SRCC and the live L. plantarum WCFS1 strain when compared to the maltodextrin stabilizing agent. This is insufficient to meet the written description requirements of the claimed genus and the broad scope of the claims. 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. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus as in the instant case, one must describe a sufficient variety of species to reflect the variation within the genus. The live L. plantarum WCFS1 strain species and the limestone SRCC species are not representative of the claimed large genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004) (“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated”).
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Possession may be shown in a variety of ways including by showing that the invention was “ready for patenting”. MPEP 2163. MPEP § 2163.02 states: ‘an objective standard for determining compliance with the written description requirement is, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed’. The courts have decided that 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. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991). Note that a mere plan or wish is insufficient to satisfy the provisions of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph. One needs to show that one has truly invented the entire breadth of the claimed invention. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed invention. Adequate written description requires more than a mere statement that it is part of the invention. In re Ruschig, 379 F.2d 990 (CCPA 1967) states that written description is one of three distinct requirements under 35 U.S.C § 112 (pre-AIA ), first paragraph. The written description provision of 35 U.S.C § 112(a) or 35 U.S.C § 112(pre-AIA ), first paragraph is severable from its enablement provision. Instant claims do not meet the written description provision of 35 U.S.C § 112(a) or (pre-AIA ), first paragraph.
Rejection(s) under 35 U.S.C § 112(b) or (Pre-AIA ) Second Paragraph
10) 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.
11) Claims 1-10 and 16 are rejected under 35 U.S.C § 112(b) or pre-AIA , second paragraph, as being indefinite, for failing to particularly point out and distinctly claim the subject matter which inventor or a joint inventor, or for the pre-AIA the Applicants regard as the invention.
(a) The dependent claim 3, as amended, is indefinite for having insufficient antecedence in the limitation “a probiotic microorganism”. See line 2. For proper antecedence, it is suggested that Applicants replace said limitation with –the probiotic microorganism--.
(b) The dependent claim 7, as amended, is indefinite for having insufficient antecedence in the limitations “probiotic microorganism” and “surface-reacted calcium carbonate”. See lines 2 and 3. For proper antecedence, it is suggested that Applicants replace said limitations with –the probiotic microorganism-- and --the surface-reacted calcium carbonate-- respectively.
(c) Claims 10 and 1 are vague, ambiguous, inconsistent, and/or indefinite with regard to the limitations: “the concentration of “viable probiotic microorganism culture” in claim 10 and “a probiotic microorganism culture” in claim 1. Claim 1 does not recite a concentration of a viable probiotic microorganism culture. One of ordinary skill in the art cannot understand in an unambiguous way that which is being claimed and the metes and bounds of the claims.
(d) New claim 16 is ambiguous and indefinite for lacking sufficient antecedence in the limitations “H2PO4-” (see line 4) “HPO42-” (see line 6). For proper antecedence, it is suggested that Applicants insert the limitation –the-- prior to each of said limitations.
(e) New claim 16 and claim 6 are ambiguous and indefinite for having improper antecedence in the non-plural limitation “the one or more ..... donor” (lines 1 and 2). Claims 16 and 6 depend from claim 1 which includes the plural limitation “one or more ..... donors”.
(f) Claim 1 is ambiguous, indefinite and has an antecedence issue with regard to the limitations “the H3O+ ion donors treatment”. There is no prior recitation of any ‘treatment’ in the claim.
(g) Claims 2-9 and 16, which depend directly or indirectly from claim 1, are also rejected as being indefinite due to the indefiniteness identified supra in claim 1.
Notice Re Prior Art Available under Both Pre-AIA and AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C § 102 and 35 U.S.C § 103 (or as subject to pre-AIA 35 U.S.C § 102 and 35 U.S.C § 103) is incorrect, any correction of the statutory basis 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.
Rejection(s) under 35 U.S.C § 102
12) 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.
13) Claims 1, 4-6, 8 and 9 are rejected under 35 U.S.C § 102(a)(1) as being anticipated by US 20140248340 A1.
US 20140248340 A1 disclosed a carrier composition or preparation comprising pharmaceutically, cosmetically or nutritionally active agents such as health-promoting probiotics bacteria and natural or synthetic surface-reacted calcium carbonate, which is a reaction product of natural or synthetic calcium carbonate with carbon dioxide and one or more acids, wherein the carbon dioxide is formed in situ by the acid treatment and/or is supplied from an external source. The natural calcium carbonate contains limestone. The surface-reacted calcium carbonate has a specific surface area in the range of from 20 m2/g to 80 m2/g, or 30 m2/g to 60 m2/g as measured using nitrogen and the BET method, which range falls well within the range recited in instant claims 5 iii). Further, the natural or synthetic calcium carbonate has a weight median grain diameter d50 in the range of from 0.1 to 50 micrometer, from 0.5 to 25 micrometer, from 0.8 to 20 micrometer, or from 1 to 10 micrometer as measured according to the sedimentation method, which range falls well within the range recited in instant claims 5 i). The prior art composition or preparation is solid or an aqueous suspension, which meets the requirements of instant claim 4. The natural or synthetic calcium content in the preparation is 40 wt-%, 60 wt-%, or 80 wt-%. The prior art surface-reacted calcium carbonate qualifies as a shelf live preservative as defined at section [0113] of Applicants’ specification. See claims 9 and 1-8; and sections [0066], [0053], [0054] and [0032]. Since both of the elements comprised in the prior art composition meet the instantly recited elements, and the ranges of the specific surface area and of the weight median grain diameter fall within the instantly recited ranges, the prior art composition comprising the probiotics bacteria and the surface-reacted calcium carbonate is expected to be stabilized absent evidence to the contrary. Two identical or substantially identical products cannot have mutually exclusive functions or effects.
Claims 1, 4-6, 8 and 9 are anticipated by US 20140248340 A1.
Double Patenting Rejection(s)
14) The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 C.F.R 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
15) Claims 1, 4-6, 8 and 9 are rejected on the ground of non-statutory obviousness-type double patenting as being unpatentable over claims 7,1 and 2-6 of US patent 9579291 B2 issued to OMYA AG.
Although the claims are not identical, they are not patentably distinct from each other because the carrier composition claimed in the ‘291 patent comprising surface-reacted natural or synthetic calcium carbonate which is a reactive product of natural or synthetic calcium carbonate with carbon dioxide and one or more acids wherein the carbon dioxide is formed in situ by the acid treatment and/or is supplied from an external source, i.e., a shelf live preservative as defined at section [0113] of Applicants’ specification, and an active pharmaceutical agent, biological agent, cosmetic agent, or nutrient agent such as health-promoting probiotic bacteria reads on instant claims. The natural or synthetic calcium carbonate contains limestone and is precipitated with aragonitic, vateritic and calcitic mineralogical crystal forms or mixtures thereof. The surface-reacted natural or synthetic calcium carbonate comprised in the ‘291 patent’s composition has a specific surface area of 200 m2/g as measured using nitrogen and the BET method or a median particle diameter size d50 of 0.1 to 50 micrometer. The composition of the ‘291 patent is in the form of an aqueous suspension and meets the requirements of instant claim 4. The composition of the ‘291 patent anticipates instant claims. Since both of the elements comprised in the prior art composition meet the instantly recited elements, and the ranges of the specific surface area and of the median diameter size fall within the instantly recited ranges, the prior art composition comprising the probiotics bacteria and the surface-reacted calcium carbonate is expected to be stabilized absent evidence to the contrary. Two identical or substantially identical products cannot have mutually exclusive functions or effects.
Relevant Art
16) The art made of record and not relied upon in any of the rejections is considered pertinent to Applicants’ disclosure:
t EP 3594289 A1 (Applicants’ IDS) disclosed the use of a surface-reacted calcium carbonate having a volume median particle size d50 of 0.1 to 90 micrometer to stabilize mint oil. See Abstract and claims.
Conclusion
17) No claims are allowed.
In the last line of claim 10, for clarity and for the purpose of distinctly claiming the subject matter, it is suggested that Applicants insert the limitation –the-- prior to the limitation “stabilizing agent”.
New claim 16 is objected to for including the redundant limitations “wherein wherein” in lines 3 and 4.
The specification is objected to for the incomplete citation of what appears to be a reference publication “(Wooten et al., 2021)”. See last page of the as-filed specification.
Conclusion
18) No claims are allowed.
Correspondence
19) Any inquiry concerning this communication or earlier communications from the Examiner should be directed to S. Devi, Ph.D., whose telephone number is (571) 272-0854. A message may be left on the Examiner’s voice mail system. The Examiner is on a flexible work schedule, however she can normally be reached Monday to Friday from 8.00 a.m. to 4.00 p.m. (EST). If attempts to reach the Examiner by telephone are unsuccessful, the Supervisor of AU 1645, Daniel E. Kolker, can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned (571) 273-8300.
20) Information regarding the status of an application may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center or Private PAIR to authorized users only. Should you have questions about access to Patent Center or the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). 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.
/S. DEVI/
S. Devi, Ph.D.Primary Examiner
Art Unit 1645
March, 2026
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