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 .
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 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.
Claim Status
Claims 1-10 are pending.
Claim 4 is objected to.
Claims 1-10 are rejected.
Priority
Applicant's claim for the benefit of a prior-filed application, PCT/KR2020/018343, filed Dec 15 2020, is acknowledged.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) to App. No. KR10-2020-0009519, filed Jan 23 2020. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should the applicant desire to obtain the benefit of foreign priority under 35 USC 119(a)-(d), a certified English translation of the foreign priority application must be submitted. Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Accordingly, each of claims 1-10 are afforded the effective filing date of Jan 23 2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on Jul 19 2022, Aug 28 2023, and Feb 19 2025 are in compliance with the provisions of 37 CFR 1.97 and have therefore been considered. Signed copies of the IDS documents are included with this Office Action.
Drawings
The Drawings submitted Jul 19 2022 are accepted.
Specification
The amendments to the title submitted Jul 19 2022 are accepted.
Claim Objections
The claims are objected to for the following informalities:
In claim 4, the comma at the end of limitation 2 should be changed to a semicolon.
In claim 4, limitation 3 should be amended to include “wherein” at the beginning of the line.
Claim Interpretation
35 U.S.C. 112(f)
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a postbiotic-based health index calculation unit that calculates a postbiotic-based health index of at least one culture in which the sample is treated with at least one intestinal environment-improving candidate material” in claim 6 and “the postbiotic-based health index calculation unit selects a culture having a greatest difference between postbiotic-based health index of a control group in which the sample is not treated with any intestinal environment-improving candidate material and the postbiotic-based health index of the at least one culture” in claim 9.
Regarding the three-prong test: (A) “unit” is a substitute for “means” that is a generic placeholder; (B) “unit” is modified by the functional language “that”; (C) “unit” is modified by “postbiotic-based health index calculation”, which does not provide sufficient structure for performing the step of calculating a postbiotic-based health index of at least one culture in which the sample is treated with at least one intestinal environment-improving candidate material or selecting a culture having a greatest difference between postbiotic-based health index of a control group in which the sample is not treated with any intestinal environment-improving candidate material and the postbiotic-based health index of the at least one culture. The specification discloses a postbiotic-based health index calculation unit that may use Personalized Pharmaceutical Meta-Analysis Screening (PMAS) to calculate a postbiotic-based health index of at least one culture in which a sample is treated with at least one intestinal environment-improving candidate material, where various descriptions of what the postbiotic-based health index calculation unit may calculate at [0049; 0053-0062; 0065-0070], but does not disclose adequate structure to perform the claimed function. See below regarding issues under 112(a) and 112(b) arising from this claim interpretation.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
It is noted that “a kit registration unit that receives registration of a kit for collecting a sample from a user device” and “a product recommendation unit that recommends at least one product for improving an intestinal environment” in claim 6 are not considered to invoke 35 USC 112(f) because the limitations merely recite receiving and outputting data, which are normal functions of a computer.
Claim Rejections - 35 USC § 112
35 U.S.C. 112(a)
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.
Claims 3 and 6-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 3 recites “acetic acid (acetate)”, “propionic acid (propionate)”, and “butyric acid (butyrate)”. It is not clear how the parenthetical terms are intended to limit the claim. It is not clear whether the parenthetical terms are intended to provide alternate names of the first terms, or if they are intended to limit the claims to those terms only. As set forth in MPEP 2173.05(d), exemplary claim language may lead to confusion over the intended scope of a claim if it is not clear whether the claimed narrower range is a limitation, as is the case in the instant claim. For compact examination, it is assumed that art teaching either the term or the parenthetical term as recited in the claim is relevant. The rejection may be overcome by clarifying the metes and bounds of the claim. Claim 8 is similarly rejected.
Claims 6 and 9 are rejected because, as outlined above under 35 USC 112(f), the disclosure does not contain adequate structure to perform the claimed functions of calculating a postbiotic-based health index of at least one culture in which the sample is treated with at least one intestinal environment-improving candidate material because the invention is not described with sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor had possession of the claimed invention. The Specification discloses a postbiotic-based health index calculation unit that may use Personalized Pharmaceutical Meta-Analysis Screening (PMAS) to calculate a postbiotic-based health index of at least one culture in which a sample is treated with at least one intestinal environment-improving candidate material, where various descriptions of what the postbiotic-based health index calculation unit may calculate at [0049; 0053-0062; 0065-0070], but does not disclose a specific algorithm for calculating the postbiotic-based health index. Claims 7-8 and 10 are rejected based on their dependency from claim 6.
With respect to the limitations, adequate written description for specific programming to carry out said functions in computer-related inventions requires disclosure of the algorithm by which to perform said function. Without the algorithm disclosed, it is unclear as to the exact structure that performs said function (see Finisar Corp. v. DirecTV Group Inc., 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); Halliburton Energy Services v. M-I LLC 514 F.3d 1244, 1256 n.7 (Fed. Cir. 2008)). This raises issues under 112(a) because without the respective algorithms disclosed, one is not apprised of the inventor or joint inventor having possession of the claimed invention.
35 U.S.C. 112(b)
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.
Claims 5-10 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 regards as the invention.
Claim 5 recites “wherein the product for improving an intestinal environment includes at least one of… food, health functional food…”. It is not clear how the terms “health functional” are intended to further limit the term “food” because there is no discussion provided in the claims or the specification. Food is defined as “material consisting essentially of protein, carbohydrate, and fat used in the body of an organism to sustain growth, repair, and vital processes and to furnish energy” (merriam-webster.com/dictionary/food), which indicates that food in general is functional as it provides energy to an organism for growth, and that such functions can be linked to health because they contribute to growth, repair, and vital processes. Therefore, it is further not clear how the terms “food” and “health functional food” in he claim are differentiated. Cor compact examination, any food will be considered to read on both “food” and “health functional food”. The rejection may be overcome by clarifying the interpretation of the term. Claim 10 is similarly rejected.
Claim 7 “recites “The solution providing server of Claim 1”. However, claim 1 is directed to a method, while claim 6 is directed to a solution providing server. It is therefore not clear whether claim 7 should depend from claim 1 or claim 6. It is assumed that claim 7 is intended to depend from claim 6. The rejection may be overcome by clarifying the dependency of the claim. Claim 8 is rejected based on its dependency from claim 7.
Regarding the claim limitation that invokes 112(f): Claim limitation “a postbiotic-based health index calculation unit that calculates a postbiotic-based health index of at least one culture in which the sample is treated with at least one intestinal environment-improving candidate material” in claim 6 and “the postbiotic-based health index calculation unit selects a culture having a greatest difference between postbiotic-based health index of a control group in which the sample is not treated with any intestinal environment-improving candidate material and the postbiotic-based health index of the at least one culture” in claim 9 invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. Claims 7-8 and 10 are rejected based on their dependency from claim 6.
The Specification indicates that the a postbiotic-based health index calculation unit that may use Personalized Pharmaceutical Meta-Analysis Screening (PMAS) to calculate a postbiotic-based health index of at least one culture in which a sample is treated with at least one intestinal environment-improving candidate material, where various descriptions of what the postbiotic-based health index calculation unit may calculate at [0049; 0053-0062; 0065-0070]. However, the claim requires a “postbiotic-based health index calculation unit that calculates a postbiotic-based health index” and “selects a culture”, and thus is programmed to perform the claimed function. This requires the disclosure of specific programming to carry out said function and in computer-related inventions said operation requires disclosure of the algorithm with which to perform said function. The limitation is indefinite as to the structure that performs said function. Without the algorithm disclosed, it is unclear as to the exact structure that performs said function (see Finisar Corp. v. DirecTV Group Inc., 86 USPQ2d 1609, 1623 (Fed. Cir. 2008); Halliburton Energy Services v. M-I LLC 514 F.3d 1244, 1256 n.7 (Fed. Cir. 2008)). This requires that the specification must disclose the specific way to perform the function and not what a skilled artisan would glean from the description, i.e. exemplary ways. Without the disclosed algorithm, the claim is unclear because there are no clear and definite boundaries to inform the public of the claim scope.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 organizes judicial exception analysis into Steps 1, 2A (Prongs One and Two) and 2B as follows below. MPEP 2106 and the following USPTO website provide further explanation and case law citations: uspto.gov/patent/laws-and-regulations/examination-policy/examination-guidance-and-training-materials.
Framework with which to Evaluate Subject Matter Eligibility:
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter;
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. a law of nature, a natural phenomenon, or an abstract idea;
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application (Prong Two); and
Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept.
Framework Analysis as Pertains to the Instant Claims:
Step 1
With respect to Step 1: yes, the claims are directed to a method and a server, i.e., a process, machine, or manufacture within the above 101 categories [Step 1: YES; See MPEP § 2106.03].
Step 2A, Prong One
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. The MPEP at 2106.04(a)(2) further explains that abstract ideas are defined as:
mathematical concepts (mathematical formulas or equations, mathematical relationships and mathematical calculations);
certain methods of organizing human activity (fundamental economic practices or principles, managing personal behavior or relationships or interactions between people); and/or
mental processes (procedures for observing, evaluating, analyzing/ judging and organizing information).
The claims also recite a law of nature or a natural phenomenon. The MPEP at 2106.04(b) further explains that laws of nature and natural phenomena include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature.
With respect to the instant claims, under the Step 2A, Prong One evaluation, the claims are found to recite abstract ideas that fall into the grouping of mental processes (in particular procedures for observing, analyzing and organizing information) and mathematical concepts (in particular mathematical relationships and formulas) as well as a law of nature or a natural phenomenon are as follows:
Independent claims 1 and 6: calculating a postbiotic-based health index of at least one culture in which the sample is treated with at least one intestinal environment-improving candidate material.
Dependent claims 2-5 and 7-10 recite further steps that limit the judicial exceptions in independent claims 1 and 6 and, as such, also are directed to those abstract ideas. For example, claims 2-3 and 7-8 further limit the postbiotic-based health index to being based on a ratio of short chain fatty acids in the culture; claims 4 and 9 further limit the calculating the postbiotic-based health index to selecting the one with the greatest difference between a control in which the sample is not treated with any intestinal environment-improving candidate material; and claims 5 and 10 further limit the product for improving an intestinal environment in the culture to at least one of probiotics, prebiotics, food, health functional food and drug, which further limits the conditions of the culture used to calculate the postbiotic-based health index.
The abstract ideas recited in the claims are evaluated under the Broadest Reasonable Interpretation (BRI) and determined to each cover performance either in the mind and/or by mathematical operation because the method only requires a user to manually calculate a postbiotic-based health index. Without further detail as to the methodology involved in “calculating”, under the BRI, one may simply, for example, use pen and paper to calculate such an index using the results of a sample cultured with at least one intestinal environment-improving candidate material. The step of “calculating” further requires mathematical techniques as the only supported embodiments, as calculating in the independent claims indicates a mathematical function, and the dependent claims limit the calculating to being a ratio, which describes a mathematical concept in words. Further support for the mathematical techniques used in the claims is provided in the specification at [0055-0063], which describes equations for calculating the ratio of short chain fatty acids, and [0066-0069], which describes an equation for calculating the difference between treated and control cultures.
The claims also recite determining a natural relationship between the microbes already present in the sample and their interaction with the at least one intestinal environment-improving candidate material. Therefore, the claims recite a law of nature or a natural phenomenon.
Therefore, claims 1 and 6 and those claims dependent therefrom recite an abstract idea and a law of nature/natural phenomenon [Step 2A, Prong 1: YES; See MPEP § 2106.04].
Step 2A, Prong Two
Because the claims do recite judicial exceptions, direction under Step 2A, Prong Two, provides that the claims must be examined further to determine whether they integrate the judicial exceptions into a practical application (MPEP 2106.04(d)). A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception. This is performed by analyzing the additional elements of the claim to determine if the judicial exceptions are integrated into a practical application (MPEP 2106.04(d).I.; MPEP 2106.05(a-h)). If the claim contains no additional elements beyond the judicial exceptions, the claim is said to fail to integrate the judicial exceptions into a practical application (MPEP 2106.04(d).III).
Additional elements, Step 2A, Prong Two
With respect to the instant recitations, the claims recite the following additional elements:
Independent claims 1 and 6: receiving registration of a kit for collecting a sample from a user device; and
recommending at least one product for improving an intestinal environment, including the at least one intestinal environment-improving candidate material based on the postbiotic- based health index of the at least one culture.
Dependent claims 4 and 9 recite steps that further limit the recited additional elements in the claims by further limiting the recommending to the product with the greatest difference.
The claims also include non-abstract computing elements. For example, independent claim 6 includes a solution providing server comprising a a kit registration unit, a postbiotic-based health index calculation unit, and a product recommendation unit.
Considerations under Step 2A, Prong Two
With respect to Step 2A, Prong Two, the additional elements of the claims do not integrate the judicial exceptions into a practical application for the following reasons. Those steps directed to data gathering, such as “receiving” data, and to data outputting, such as “recommending” a product, perform functions of collecting and outputting the data needed to carry out the judicial exceptions. Data gathering and outputting do not impose any meaningful limitation on the judicial exceptions, or on how the judicial exceptions are performed. Data gathering and outputting steps are not sufficient to integrate judicial exceptions into a practical application (MPEP 2106.05(g)).
Further steps directed to additional non-abstract computing elements of claim 6 do not describe any specific computational steps by which the “computer parts” perform or carry out the judicial exceptions, nor do they provide any details of how specific structures of the computer, such as the computer-readable recording media, are used to implement these functions. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, and therefore the claim does not integrate that judicial exceptions into a practical application. The courts have weighed in and consistently maintained that when, for example, a memory, display, processor, machine, etc.… are recited so generically (i.e., no details are provided) that they represent no more than mere instructions to apply the judicial exception on a computer, and these limitations may be viewed as nothing more than generally linking the use of the judicial exception to the technological environment of a computer (MPEP 2106.05(f)). Further, the computer system contains the recited units (i.e., software) that are used for receiving registration of a kit and recommending at least one product (which are data gathering and outputting elements that do not integrate the judicial exceptions) and a calculating a postbiotic-based health index (which does not integrate the judicial exceptions but merely applies them to a computer). Thus, the limitations only generically link the use of the judicial exceptions to the technological environment of a computer.
The specification as published discloses that the method is a solution for improving an intestinal environment at [0031], but does not provide a clear explanation for how the additional elements provide these improvements. Therefore, the additional elements do not clearly improve the functioning of a computer, or comprise an improvement to any other technical field. Further, the additional elements do not clearly affect a particular treatment; they do not clearly require or set forth a particular machine; they do not clearly effect a transformation of matter; nor do they clearly provide a nonconventional or unconventional step (MPEP2106.04(d)).
Thus, none of the claims recite additional elements which would integrate a judicial exception into a practical application, and the claims are directed to one or more judicial exceptions [Step 2A, Prong 2: NO; See MPEP § 2106.04(d)].
Step 2B (MPEP 2106.05.A i-vi)
According to analysis so far, the additional elements described above do not provide significantly more than the judicial exception. A determination of whether additional elements provide significantly more also rests on whether the additional elements or a combination of elements represents other than what is well-understood, routine, and conventional. Conventionality is a question of fact and may be evidenced as: a citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates a well-understood, routine or conventional nature of the additional element(s); a citation to one or more of the court decisions as discussed in MPEP 2106(d)(II) as noting the well-understood, routine, conventional nature of the additional element(s); a citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and/or a statement that the examiner is taking official notice with respect to the well-understood, routine, conventional nature of the additional element(s).
With respect to the instant claims, the courts have found that receiving and outputting data are well-understood, routine, and conventional functions of a computer when claimed in a merely generic manner or as insignificant extra-solution activity (see Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information), buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network), Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015), and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93, as discussed in MPEP 2106.05(d)(II)(i)). As such, the claims simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception (MPEP2106.05(d)). The data gathering steps as recited in the instant claims constitute a general link to a technological environment which is insufficient to constitute an inventive concept which would render the claims significantly more than the judicial exception (MPEP2106.05(g)&(h)).
With respect to claims 6 and those claims dependent therefrom, the computer-related elements or the general purpose computer do not rise to the level of significantly more than the judicial exception. The claims state nothing more than a generic computer which performs the functions that constitute the judicial exceptions. Hence, these are mere instructions to apply the judicial exceptions using a computer, which the courts have found to not provide significantly more when recited in a claim with a judicial exception (Alice Corp., 573 U.S. at 225-26, 110 USPQ2d at 1984; see MPEP 2106.05(A)). The specification also notes that computer processors and systems, as example, are commercially available or widely used at [0039]. The additional elements are set forth at such a high level of generality that they can be met by a general purpose computer. Therefore, the computer components constitute no more than a general link to a technological environment, which is insufficient to constitute an inventive concept that would render the claims significantly more than the judicial exceptions (see MPEP 2106.05(b)I-III).
Taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself [Step 2B: NO; See MPEP § 2106.05].
Therefore, the instant claims are not drawn to eligible subject matter as they are directed to one or more judicial exceptions without significantly more. For additional guidance, applicant is directed generally to the MPEP § 2106.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 4-7, and 9-10 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gurry (US 2022/0351803; priority Sep 23 2019; newly cited).
Claim 1 discloses a method for providing a personalized solution for improving an intestinal environment based on a postbiotic-based health index. Claim 6 discloses a solution providing server for providing a personalized solution for improving an intestinal environment based on a postbiotic-based health index, comprising a kit registration unit, a postbiotic-based health index calculation unit, and a product recommendation unit.
Gurry discloses an in silico method for predicting a response to different dietary fibres based on the analysis and measuring of the fermentation or metabolic capabilities of a subjects gut microbiota as well as a computer software product and an apparatus for predicting a response of a subject to different dietary fibres (abstract). Gurry teaches an apparatus with computer software or programs implementing their method [0020-0021; 0118], which is considered to read on the server and units of claim 6.
The method steps of claim 1 and the actions performed by the unit of claim 6 comprise:
receiving registration of a kit for collecting a sample from a user device;
Gurry teaches kits for collecting stool and a mailer diagnostic kit that can maintain the sample ‘stable’ for sufficiently long that it can be shipped from anywhere in the world to a sequencing or treatment facility [0006; 0015; 0157]. Gurry further teaches a user interface configured to receive a subject’s sample [0021; 0119]. It is therefore considered that the system of Gurry would receive information about the kit with the user’s sample, including registration as instantly claimed.
calculating a postbiotic-based health index of at least one culture in which the sample is treated with at least one intestinal environment-improving candidate material; and
Gurry teaches homogenizing stool from participants in a slurry (i.e., culture), spiking the slurry with three different dietary fiber inputs (inulin, pectin or cellulose; i.e., intestinal environment-improving candidate material), and quantifying short-chain fatty acid (SCFA) content at various timepoints [0173-0184; 0213]. Gurry teaches determining a standardized score of the resulting SCFA production rates in response to the different dietary fibers as an individual’s Microbial Metabolic Phenotype (MMP) (i.e., a postbiotic-based health index) [0214]. See also [0160-0161].
recommending at least one product for improving an intestinal environment, including the at least one intestinal environment-improving candidate material based on the postbiotic-based health index of the at least one culture.
Gurry teaches that the individuals could be grouped based on their MMPs, indicating that improving an individual's production of a given SCFA will not necessarily rely on the same polysaccharide to reach the same effect; put differently, the same polysaccharide will have different effects in different individuals depending on their MMP [0214]. Gurry teaches using the MMPs to guide dietary interventions [0165; 0214]. Gurry teaches formulate personalized dietary recommendations from these predictions, for example which specific dietary fibres should be consumed to maximize the production of a given Short Chain Fatty Acid [0015], which reads on recommending at least one product for improving an intestinal environment as instantly claimed.
Regarding claims 2 and 7, Gurry teaches claims 1 and 6 as described above. Claims 2 and 7 further add that the postbiotic-based health index is based on a ratio of short chain fatty acids in the culture.
Gurry teaches homogenizing stool from participants in a slurry (i.e., culture), spiking the slurry with three different dietary fiber inputs (inulin, pectin or cellulose; i.e., intestinal environment-improving candidate material), and quantifying short-chain fatty acid (SCFA) content at various timepoints [0213] to determine an individual’s Microbial Metabolic Phenotype (MMP) (i.e., a postbiotic-based health index) [0214]. As Gurry teaches that individuals produce different quantities and proportions of SCFAs from the same inputs ([0014; 0214]; FIG. 3), it is considered that the MMP of Gurry is based on a ratio of short chain fatty acids as instantly claimed.
Regarding claims 4 and 9, Gurry teaches claims 1 and 6 as described above. Claims 4 and 9 further add that the calculating a postbiotic-based health index includes: selecting a culture having a greatest difference between a postbiotic-based health index of a control group in which the sample is not treated with any intestinal environment-improving candidate material and the postbiotic-based health index of the at least one culture, and the recommending at least one product for improving an intestinal environment includes: recommending a product for improving an intestinal environment, including the intestinal environment-improving candidate material used for culturing the culture having the greatest difference.
Gurry teaches that during the spike-in experiments, samples had controls with no spike-ins [0102; 0173-0176]. Gurry teaches that the personalized dietary recommendations are formulated by identifying the dietary fibers inputs that result in the highest and lowest production of metabolites of interest by the subject's microbiota so as to establish personal care product to the subject [0078].
Regarding claims 5 and 10, Gurry teaches claims 1 and 6 as described above. Claims 5 and 10 further add that the product for improving an intestinal environment includes at least one of probiotics, prebiotics, food, health functional food and drug.
Gurry teaches that chemical spike-ins refer to specific dietary fibres, complex polysaccharides or other dietary ingredients (i.e. foods/health functional foods), but can also include drugs/medications [0133].
Claim Rejections - 35 USC § 103
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.
A. Claims 1-10 are alternately rejected under 35 U.S.C. 103 as being unpatentable over Holzapfel et al. (WO 2019/168,391; corresponds to KR-10-2019-010914 cited on the Jul 19 2022 IDS; newly cited) in view of Gurry (US 2022/0351803; priority Sep 23 2019; newly cited).
Claim 1 discloses a method for providing a personalized solution for improving an intestinal environment based on a postbiotic-based health index. Claim 6 discloses a solution providing server for providing a personalized solution for improving an intestinal environment based on a postbiotic-based health index, comprising a kit registration unit, a postbiotic-based health index calculation unit, and a product recommendation unit.
Holzapfel discloses a method for screening personalized probiotics, foods, health-functional foods, and drugs by using PMAS (Personalized Pharmaceutical Meta-Analysis Screening) (abstract). Holzapfel discloses a system (i.e., server) (p. 2, par. 17; p. 3, par. 6; p. 5, par. 1) with a screening algorithm (p. 4, par. 11), which is considered to read on the units of claim 6.
The method steps of claim 1 and the actions performed by the unit of claim 6 comprise:
receiving registration of a kit for collecting a sample from a user device;
Holzapfel teaches acquiring a personal sample of a user (abstract; p. 2, par. 8). Holzapfel teaches
Holzapfel does not teach receiving registration of a kit from a user device. See below for teachings by Gurry regarding a kit.
calculating a postbiotic-based health index of at least one culture in which the sample is treated with at least one intestinal environment-improving candidate material; and
Holzapfel teaches pretreating the sample to mix the sample with a predetermined number of candidate substances and analyzing the mixture of the sample (i.e., culture) and the candidate substances to screen a personalized microbiota-improving candidate substance (abstract; p. 2, par. 8; p. 3, par. 6; p. 4, par. 1). As Holzapfel teaches that the sample may be from the feces of the user (p. 2, par. 11; p. 3, second to last paragraph), it is considered that such a sample would convey information about the intestine of the user, and the candidate substances of Holzapfel therefore read on intestinal environment-improving candidate materials as instantly claimed. Holzapfel teaches a data analysis process of the screened samples (p. 3, par. 7) to determine whether the measured parameters are in or out of a normal range (p. 4, par. 7), which reads on calculating a postbiotic-based health index as instantly claimed.
recommending at least one product for improving an intestinal environment, including the at least one intestinal environment-improving candidate material based on the postbiotic-based health index of the at least one culture.
Holzapfel teaches that the screening method can be used to verify a personalized candidate material (p. 2, par. 17), where personalized probiotics, foods, functional foods, and medicines are selected through derived data (p. 3, par. 7).
Holzapfel does not teach receiving a registration of a kit from a user device.
However, the prior art to Gurry discloses an in silico method for predicting a response to different dietary fibres based on the analysis and measuring of the fermentation or metabolic capabilities of a subjects gut microbiota as well as a computer software product and an apparatus for predicting a response of a subject to different dietary fibres (abstract). Gurry teaches kits for collecting stool and a mailer diagnostic kit that can maintain the sample ‘stable’ for sufficiently long that it can be shipped from anywhere in the world to a sequencing or treatment facility [0006; 0015; 0157]. Gurry further teaches a user interface configured to receive a subject’s sample [0021; 0119]. It is therefore considered that the system of Gurry would receive information about the kit with the user’s sample, including registration as instantly claimed.
Regarding claims 1 and 6, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, Holzapfel and Gurry because both references disclose methods for analyzing stool samples to provide personalized treatments for modifying the gut microbiome. The motivation to include the mailer kit of Gurry would have been to maintain the sample ‘stable’ for sufficiently long that it can be shipped from anywhere in the world to a sequencing or treatment facility, as taught by Gurry [0015].
Regarding claims 2 and 7, Holzapfel in view of Gurry teach claims 1 and 6 as described above. Claims 2 and 7 further add that the postbiotic-based health index is based on a ratio of short chain fatty acids in the culture.
Holzapfel teaches analyzing the short chain fatty acids from the cultures (p. 2, par. 10 and 12-15; p. 3, par. 4). Holzapfel teaches analyzing the short chain fatty acids acetate, propionate, and butyrate (p. 2, par. 14; p. 3, par. 4; p. 4, par. 6). As Holzapfel teaches examining the ratio of butyric acid (p. 4, third to last paragraph), it is considered that Holzapfel fairly teaches a postbiotic-based health index is based on a ratio of short chain fatty acids in the culture as instantly claimed.
Regarding claims 3 and 8, Holzapfel in view of Gurry teach claims 1-2 and 6-7 as described above. Claims 3 and 8 further add that the postbiotic-based health index is based on a ratio of acetic acid (acetate) to propionic acid (propionate) and butyric acid (butyrate).
Holzapfel teaches analyzing acetate, propionate, and butyrate (p. 2, par. 14; p. 3, par. 4; p. 4, par. 6). Holzapfel teaches examining the ratio of butyric acid (p. 4, third to last paragraph). Holzapfel does not explicitly teach a ratio acetic acid to propionic and butyric acid as instantly claimed.
However, Gurry teaches that the Short Chain Fatty Acids (SCFAs) acetate, propionate and butyrate (the major by-products of the microbial fermentation of dietary fibers in the gut) exert a number of forces on the host's physiology, including increases in microbial acetate production and turnover have been shown to activate glucose-stimulated insulin secretion via a gut-brain axis mediated process, which can lead to insulin resistance and subsequent obesity, in addition to increasing a patient's risk of developing Type 2 diabetes, whereas propionate and butyrate, in contrast, activate gluconeogenesis, which has beneficial effects to host metabolism and plasma glucose regulation [0002]. Gurry teaches that individuals produce different quantities and proportions of SCFAs from the same inputs ([0014; 0214]; FIG. 3).
Regarding claims 3 and 8, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, in the course of routine experimentation and with a reasonable expectation of success, Holzapfel and Gurry to examine the ratio of acetate to propionate and butyrate in the samples. One of ordinary skill in the art would have been motivated to make such a modification because individuals produce different quantities and proportions of SCFAs from the same inputs, as taught by Gurry ([0014; 0214]; FIG. 3), and it is known that increased levels of acetate can be harmful to the host while increased levels of propionate and butyrate can be beneficial, as taught by Gurry [0002].
Regarding claims 4 and 9, Holzapfel in view of Gurry teach claims 1 and 6 as described above. Claims 4 and 9 further add that the calculating a postbiotic-based health index includes: selecting a culture having a greatest difference between a postbiotic-based health index of a control group in which the sample is not treated with any intestinal environment-improving candidate material and the postbiotic-based health index of the at least one culture, and the recommending at least one product for improving an intestinal environment includes: recommending a product for improving an intestinal environment, including the intestinal environment-improving candidate material used for culturing the culture having the greatest difference.
Holzapfel teaches that the treatment with the highest proportion (i.e., postbiotic-based health index) was selected as the best or optimal treatment/improvement material (p. 4, par. 8-9).
Regarding claims 5 and 10, Holzapfel in view of Gurry teach claims 1 and 6 as described above. Claims 5 and 10 further add that the product for improving an intestinal environment includes at least one of probiotics, prebiotics, food, health functional food and drug.
Holzapfel teaches a method for verifying personalized probiotics, foods, functional foods and drugs/pharmaceuticals (abstract; p. 1, last paragraph; p. 3, par. 6).
B. Claims 3 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Gurry, as applied to claims 1-2 and 6-7 in the above 35 USC 102 rejection, and in further view of the features of Gurry.
Regarding claims 3 and 8, Gurry teaches claims 1-2 and 6-7 as described above. Claims 3 and 8 further add that the postbiotic-based health index is based on a ratio of acetic acid (acetate) to propionic acid (propionate) and butyric acid (butyrate).
Gurry teaches that the Short Chain Fatty Acids (SCFAs) acetate, propionate and butyrate (the major by-products of the microbial fermentation of dietary fibers in the gut) exert a number of forces on the host's physiology, including increases in microbial acetate production and turnover have been shown to activate glucose-stimulated insulin secretion via a gut-brain axis mediated process, which can lead to insulin resistance and subsequent obesity, in addition to increasing a patient's risk of developing Type 2 diabetes, whereas propionate and butyrate, in contrast, activate gluconeogenesis, which has beneficial effects to host metabolism and plasma glucose regulation [0002]. Gurry teaches that individuals produce different quantities and proportions of SCFAs from the same inputs ([0014; 0214]; FIG. 3). Gurry does not explicitly teach determining a ratio of acetic acid (acetate) to propionic acid (propionate) and butyric acid (butyrate) as instantly claimed.
However, regarding claims 3 and 8, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, in the course of routine experimentation and with a reasonable expectation of success, Holzapfel and Gurry to examine the ratio of acetate to propionate and butyrate in the samples. One of ordinary skill in the art would have been motivated to make such a modification because individuals produce different quantities and proportions of SCFAs from the same inputs, as taught by Gurry ([0014; 0214]; FIG. 3), and it is known that increased levels of acetate can be harmful to the host while increased levels of propionate and butyrate can be beneficial, as taught by Gurry [0002].
Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
A. Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2-5, and 10-11 of U.S. Patent No. 11,237,172 in view of Gurry (US 2022/0351803; priority Sep 23 2019; newly cited).
Regarding instant claims 1 and 6, reference claims 1 and 11 discloses analyzing one culture in which the sample is treated with at least one intestinal environment-improving candidate material, but does not disclose the remaining instant limitations.
However, the prior art to Gurry discloses an in silico method for predicting a response to different dietary fibres based on the analysis and measuring of the fermentation or metabolic capabilities of a subjects gut microbiota as well as a computer software product and an apparatus for predicting a response of a subject to different dietary fibres (abstract). Gurry teaches an apparatus with computer software or programs implementing their method [0020-0021; 0118], which is considered to read on the server and units of claim 6. Gurry teaches kits for collecting stool and a mailer diagnostic kit that can maintain the sample ‘stable’ for sufficiently long that it can be shipped from anywhere in the world to a sequencing or treatment facility [0006; 0015; 0157]. Gurry further teaches a user interface configured to receive a subject’s sample [0021; 0119]. It is therefore considered that the system of Gurry would receive information about the kit with the user’s sample, including registration as instantly claimed. Gurry teaches homogenizing stool from participants in a slurry (i.e., culture), spiking the slurry with three different dietary fiber inputs (inulin, pectin or cellulose; i.e., intestinal environment-improving candidate material), and quantifying short-chain fatty acid (SCFA) content at various timepoints [0173-0184; 0213]. Gurry teaches determining a standardized score of the resulting SCFA production rates in response to the different dietary fibers as an individual’s Microbial Metabolic Phenotype (MMP) (i.e., a postbiotic-based health index) [0214]. See also [0160-0161]. Gurry teaches that the individuals could be grouped based on their MMPs, indicating that improving an individual's production of a given SCFA will not necessarily rely on the same polysaccharide to reach the same effect; put differently, the same polysaccharide will have different effects in different individuals depending on their MMP [0214]. Gurry teaches using the MMPs to guide dietary interventions [0165; 0214]. Gurry teaches formulate personalized dietary recommendations from these predictions, for example which specific dietary fibres should be consumed to maximize the production of a given Short Chain Fatty Acid [0015], which reads on recommending at least one product for improving an intestinal environment as instantly claimed.
Regarding claims 2 and 7, reference claim 4 discloses the instant limitations except for a ratio.
However, Gurry teaches homogenizing stool from participants in a slurry (i.e., culture), spiking the slurry with three different dietary fiber inputs (inulin, pectin or cellulose; i.e., intestinal environment-improving candidate material), and quantifying short-chain fatty acid (SCFA) content at various timepoints [0213] to determine an individual’s Microbial Metabolic Phenotype (MMP) (i.e., a postbiotic-based health index) [0214]. As Gurry teaches that individuals produce different quantities and proportions of SCFAs from the same inputs ([0014; 0214]; FIG. 3), it is considered that the MMP of Gurry is based on a ratio of short chain fatty acids as instantly claimed.
Regarding claims 3 and 8, reference claim 5 discloses the instant limitations except for a ratio.
However, Gurry teaches that the Short Chain Fatty Acids (SCFAs) acetate, propionate and butyrate (the major by-products of the microbial fermentation of dietary fibers in the gut) exert a number of forces on the host's physiology, including increases in microbial acetate production and turnover have been shown to activate glucose-stimulated insulin secretion via a gut-brain axis mediated process, which can lead to insulin resistance and subsequent obesity, in addition to increasing a patient's risk of developing Type 2 diabetes, whereas propionate and butyrate, in contrast, activate gluconeogenesis, which has beneficial effects to host metabolism and plasma glucose regulation [0002]. Gurry teaches that individuals produce different quantities and proportions of SCFAs from the same inputs ([0014; 0214]; FIG. 3). Gurry does not explicitly teach determining a ratio of acetic acid (acetate) to propionic acid (propionate) and butyric acid (butyrate) as instantly claimed.
Regarding claims 3 and 8, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, in the course of routine experimentation and with a reasonable expectation of success, Holzapfel and Gurry to examine the ratio of acetate to propionate and butyrate in the samples. One of ordinary skill in the art would have been motivated to make such a modification because individuals produce different quantities and proportions of SCFAs from the same inputs, as taught by Gurry ([0014; 0214]; FIG. 3), and it is known that increased levels of acetate can be harmful to the host while increased levels of propionate and butyrate can be beneficial, as taught by Gurry [0002].
Regarding claims 4 and 9, reference claims 10-11 discloses comparing the result of analysis from the step (c) and the result of analysis on a control group, but does not disclose the remaining instant limitations.
However, Gurry teaches that during the spike-in experiments, samples had controls with no spike-ins [0102; 0173-0176]. Gurry teaches that the personalized dietary recommendations are formulated by identifying the dietary fibers inputs that result in the highest and lowest production of metabolites of interest by the subject's microbiota so as to establish personal care product to the subject [0078].
Regarding claims 5 and 10, reference claims 2-3 discloses the instant limitations as L-cysteine and mucin are considered to recite prebiotics, as supported by the reference disclosure (col. 11, lines 30-35).
Regarding claims 1-10, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the reference patent and Gurry because each reference discloses methods for screening stool samples to provide personalized treatments for modifying the gut microbiome. The motivation would have been to guide future dietary interventions, as taught by Gurry [0214].
B. Claims 1-10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5-6, and 11 of U.S. Patent No. 12,282,026 in view of Gurry (US 2022/0351803; priority Sep 23 2019; newly cited).
Regarding instant claims 1 and 6, reference claim 1 discloses analyzing one culture in which the sample is treated with at least one intestinal environment-improving candidate material, but does not disclose the remaining instant limitations.
However, the prior art to Gurry discloses an in silico method for predicting a response to different dietary fibres based on the analysis and measuring of the fermentation or metabolic capabilities of a subjects gut microbiota as well as a computer software product and an apparatus for predicting a response of a subject to different dietary fibres (abstract). Gurry teaches an apparatus with computer software or programs implementing their method [0020-0021; 0118], which is considered to read on the server and units of claim 6. Gurry teaches kits for collecting stool and a mailer diagnostic kit that can maintain the sample ‘stable’ for sufficiently long that it can be shipped from anywhere in the world to a sequencing or treatment facility [0006; 0015; 0157]. Gurry further teaches a user interface configured to receive a subject’s sample [0021; 0119]. It is therefore considered that the system of Gurry would receive information about the kit with the user’s sample, including registration as instantly claimed. Gurry teaches homogenizing stool from participants in a slurry (i.e., culture), spiking the slurry with three different dietary fiber inputs (inulin, pectin or cellulose; i.e., intestinal environment-improving candidate material), and quantifying short-chain fatty acid (SCFA) content at various timepoints [0173-0184; 0213]. Gurry teaches determining a standardized score of the resulting SCFA production rates in response to the different dietary fibers as an individual’s Microbial Metabolic Phenotype (MMP) (i.e., a postbiotic-based health index) [0214]. See also [0160-0161]. Gurry teaches that the individuals could be grouped based on their MMPs, indicating that improving an individual's production of a given SCFA will not necessarily rely on the same polysaccharide to reach the same effect; put differently, the same polysaccharide will have different effects in different individuals depending on their MMP [0214]. Gurry teaches using the MMPs to guide dietary interventions [0165; 0214]. Gurry teaches formulate personalized dietary recommendations from these predictions, for example which specific dietary fibres should be consumed to maximize the production of a given Short Chain Fatty Acid [0015], which reads on recommending at least one product for improving an intestinal environment as instantly claimed.
Regarding claims 2 and 7, reference claim 5 discloses the instant limitations except for a ratio.
However, Gurry teaches homogenizing stool from participants in a slurry (i.e., culture), spiking the slurry with three different dietary fiber inputs (inulin, pectin or cellulose; i.e., intestinal environment-improving candidate material), and quantifying short-chain fatty acid (SCFA) content at various timepoints [0213] to determine an individual’s Microbial Metabolic Phenotype (MMP) (i.e., a postbiotic-based health index) [0214]. As Gurry teaches that individuals produce different quantities and proportions of SCFAs from the same inputs ([0014; 0214]; FIG. 3), it is considered that the MMP of Gurry is based on a ratio of short chain fatty acids as instantly claimed.
Regarding claims 3 and 8, reference claim 6 discloses the instant limitations except for a ratio.
However, Gurry teaches that the Short Chain Fatty Acids (SCFAs) acetate, propionate and butyrate (the major by-products of the microbial fermentation of dietary fibers in the gut) exert a number of forces on the host's physiology, including increases in microbial acetate production and turnover have been shown to activate glucose-stimulated insulin secretion via a gut-brain axis mediated process, which can lead to insulin resistance and subsequent obesity, in addition to increasing a patient's risk of developing Type 2 diabetes, whereas propionate and butyrate, in contrast, activate gluconeogenesis, which has beneficial effects to host metabolism and plasma glucose regulation [0002]. Gurry teaches that individuals produce different quantities and proportions of SCFAs from the same inputs ([0014; 0214]; FIG. 3). Gurry does not explicitly teach determining a ratio of acetic acid (acetate) to propionic acid (propionate) and butyric acid (butyrate) as instantly claimed.
Regarding claims 3 and 8, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify, in the course of routine experimentation and with a reasonable expectation of success, Holzapfel and Gurry to examine the ratio of acetate to propionate and butyrate in the samples. One of ordinary skill in the art would have been motivated to make such a modification because individuals produce different quantities and proportions of SCFAs from the same inputs, as taught by Gurry ([0014; 0214]; FIG. 3), and it is known that increased levels of acetate can be harmful to the host while increased levels of propionate and butyrate can be beneficial, as taught by Gurry [0002].
Regarding claims 4 and 9, reference claim 11 discloses comparing the result of analysis from the step (c) and the result of analysis on a control group, but does not disclose the remaining instant limitations.
However, Gurry teaches that during the spike-in experiments, samples had controls with no spike-ins [0102; 0173-0176]. Gurry teaches that the personalized dietary recommendations are formulated by identifying the dietary fibers inputs that result in the highest and lowest production of metabolites of interest by the subject's microbiota so as to establish personal care product to the subject [0078].
Regarding claims 5 and 10, reference claim 3 discloses the instant limitations.
Regarding claims 1-10, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the reference patent and Gurry because each reference discloses methods for screening stool samples to provide personalized treatments for modifying the gut microbiome. The motivation would have been to guide future dietary interventions, as taught by Gurry [0214].
Conclusion
No claims are allowed.
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/JANNA NICOLE SCHULTZHAUS/Examiner, Art Unit 1685