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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/16/2024, 07/09/2025, 01/13/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Paras[0035] and [0037] recite “filer”, which should be “filter”.
Para[0072] recites “the vertical axis”, which should be “the horizontal axis”.
Para[0075] (page 15 line 28) recites “14B”, which should be “14A”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 (line 3), 5 (line 5), and 9 (line 4) recite “specified about a culture solution” and Claims 1 (line 7), 5 (line 9), and 9 (line 8) recite “index about the weight of the metabolite”, which are indefinite. It is unclear whether the weight is measured from, calculated for, associated with, or contained in the culture solution. For at least these reasons claims 1, 5 and 9 and further dependent claims 2-4, 6-8 and 10-12 are indefinite.
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 1-12 are rejected under 35 U.S.C. 101. The claimed invention is directed to the abstract concept of performing mental steps without significantly more. The claim(s) recite(s) the following abstract concepts in BOLD of
With regards to Claim 1,
A method for providing information about a metabolite, the method comprising:
obtaining a weight of the metabolite specified about a culture solution in a vessel;
obtaining a weight of a microorganism specified about the culture solution in the vessel;
deriving an index about the weight of the metabolite using the weight of the metabolite and an inverse of the weight of the microorganism; and
outputting the index.
With regards to Claim 5,
An analysis system that provides information about a weight of a metabolite of a microorganism, the analysis system comprising
an information processing apparatus, wherein
the information processing apparatus is configured to
obtain a weight of the metabolite specified about a culture solution of the microorganism in a vessel,
obtain a weight of the microorganism specified about the culture solution,
derive an index about the weight of the metabolite using the weight of the metabolite and an inverse of the weight of the microorganism, and
output the index.
With regards to Claim 9,
A non-transitory computer-readable storage medium storing a program executed by a computer that provides information about a metabolite, the program causing the computer to perform:
obtaining a weight of the metabolite specified about a culture solution in a vessel;
obtaining a weight of a microorganism specified about the culture solution in the vessel;
deriving an index about the weight of the metabolite using the weight of the metabolite and an inverse of the weight of the microorganism; and
outputting the index.
Under step 1 of the eligibility analysis, we determine whether the claims are to a statutory category by considering whether the claimed subject matter falls within the four statutory categories of patentable subject matter identified by 35 U.S.C. 101: process, machine, manufacture, or composition of matter. The above claims are considered to be in a statutory category of a process.
Under Step 2A, Prong One, we consider whether the claims recite a judicial exception (abstract idea). In the above claims, the highlighted portions constitute abstract ideas because, under a broadest reasonable interpretation, they recite limitations that fall into/recite abstract idea exceptions. Specifically, under the 2019 Revised Patent Subject Matter Eligibility Guidance, they fall into the grouping of subject matter that, when recited as such in a claim limitation, cover performing mathematics or mental steps, see MPEP 2106.04(a)(2). Additionally, the claim limitations merely indicate a field of use or technological environment in which the judicial exception is performed, which is the field of metabolomics.
Next, under Step 2A, Prong Two, we consider whether the claims that recite judicial exceptions are integrated into a practical application. In this step, we evaluate whether the claims recite additional elements that integrate the exceptions into a practical application of the exceptions. The judicial exceptions are not integrated into a practical application because there is no improvement to another technology or technical field; improvements to the functioning of the computer itself; a particular machine; effecting a transformation or reduction of a particular article to a different state or thing. Examiner notes that even though the claimed methods are tied to a particular machine or apparatus (i.e. the analysis system), it does not represent an improvement to another technology or technical field as the analysis system was already produced before the mental steps explained in Step 2A Prong 1. Similarly, there are no other meaningful limitations linking the use to a particular technological environment. Finally, there is nothing in the claim that indicates an improvement to the functioning of the computer itself or transform a particular article to a new state.
Finally, under Step 2B, we consider whether the additional elements are sufficient to amount to significantly more than the abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because every step in BOLD of Claims 1, 5, and 9 point to a mental or mathematical step. In addition, in Claims 1 and 9 the step of obtaining a weight of the metabolite specified about a culture solution in a vessel; obtaining a weight of a microorganism specified about the culture solution in the vessel; and outputting the index and for Claim 5 the steps of obtain a weight of the metabolite specified about a culture solution of the microorganism in a vessel, obtain a weight of the microorganism specified about the culture solution, output the index amounts to nothing more than necessary data gathering and outputting as recited in MPEP section 2106.05(g). Necessary data gathering (i.e. receiving data) and outputting is considered extra solution activity in light of Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092- 93 (Fed. Cir. 2015).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exceptions because an analysis system, an information processing apparatus, and a non-transitory computer-readable storage medium storing a program executed by a computer are generic computer elements and not considered significantly more than the abstract ideas. As recited in the MPEP, 2106.05(b), merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 134 S. Ct. 2347, 2359-60, 110 USPQ2d 1976, 1984 (2014). See also OIP Techs. v. Amazon.com, 788 F.3d 1359, 1364, 115 USPQ2d 1090, 1093-94.
Claims 2-4, 6-8, and 10-12 are rejected under 35 U.S.C. 101 as they are further directed to abstract ideas without including additional limitations that integrate the abstract ideas into a practical application.
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.
Claim(s) 1-2, 6-7, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berkes (US 20140037688 A1) in view of Fujita (US 20150001405 A1).
With regards to Claims 1 and 9, Berkes teaches
obtaining a weight of the metabolite (See Para[0075] ““In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition) of at least about 1 μg/g, 5 μg/g, 20 μg/g, 50 μg/g, 0.1 mg/g, 0.5 mg/g, 1 mg/g, 5 mg/g, 10 mg/g, 50 mg/g, 100 mg/g, or 500 mg/g, wherein the ingredient is selected from the group consisting of extracts of microorganisms, chemical substituents, cellular or acellular components, and/or metabolites of probiotic microorganisms (i.e. the weight of the metabolite)”) specified about a culture solution in a vessel(See Para[0069] “During culture of any organism for use in the invention (i.e. specified about the culture solution in the vessel as the culture solution is grown in a container or vessel), cultures may or may not be grown to maximal plateau growth phase at which time they may be harvested for maximal biofilm production.”);
obtaining a weight of a microorganism (See Abstract “the subject invention provides anti-biofilm compositions comprising one or more probiotic organisms”, where the weight of the composition is defined, see Para[0075] “In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition)”. Therefore, the weight of the microorganism, which is the probiotic organism (See Para[0118] “the probiotic organism(s) employable for use in this invention may not be living; moreover, they may, in fact, include micro-organisms or fractions thereof that would normally be considered commensal or even pathogenic to the human host”. Therefore, the probiotic organism(s) include microorganisms), is obtained.) specified about the culture solution in the vessel (See Para[0069] “During culture of any organism for use in the invention (i.e. specified about the culture solution in the vessel as the culture solution is grown in a container or vessel), cultures may or may not be grown to maximal plateau growth phase at which time they may be harvested for maximal biofilm production.”);
deriving an index about the weight of the metabolite using the weight of the metabolite and an inverse of the weight of the microorganism (See Para[0075] “In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition) of at least about 1 μg/g, 5 μg/g, 20 μg/g, 50 μg/g, 0.1 mg/g, 0.5 mg/g, 1 mg/g, 5 mg/g, 10 mg/g, 50 mg/g, 100 mg/g, or 500 mg/g, wherein the ingredient is selected from the group consisting of extracts of microorganisms, chemical substituents, cellular or acellular components, and/or metabolites of probiotic microorganisms (i.e. the weight of the metabolite), honey, hive products, biosurfactants, prebiotics, plant extracts, and vitamin D.” Therefore, the concentration is a derived index about the weight of the metabolite as it uses the weight of the metabolite and the inverse of the weight of the microorganism, as the composition is a probiotic organism (See Para[0118] “the probiotic organism(s) employable for use in this invention may not be living; moreover, they may, in fact, include micro-organisms or fractions thereof that would normally be considered commensal or even pathogenic to the human host”. Therefore, the probiotic organism(s) include microorganisms).).
Berkes is silent to the language of
and outputting the index.
Fujita teaches
and outputting the index (See Para[0140] “The concentration of the biogenic particles 101 in the collected particles 100, which is calculated by the calculation unit 411, is output from the control unit 41 to the display unit 45.” Therefore, the index, which is the concentration, is calculated and outputted.).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Berkes wherein and outputting the index is done like in Fujita in order to have a method to display the results.
With regards to Claims 2, 6, and 10, Berkes and Fujita teach the limitations of Claim 1, 5, and 9. Berkes further teaches
the deriving the index includes deriving the index by calculating a product of the weight of the metabolite and the inverse of the weight of the microorganism (See Para[0075] “In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition) of at least about 1 μg/g, 5 μg/g, 20 μg/g, 50 μg/g, 0.1 mg/g, 0.5 mg/g, 1 mg/g, 5 mg/g, 10 mg/g, 50 mg/g, 100 mg/g, or 500 mg/g, wherein the ingredient is selected from the group consisting of extracts of microorganisms, chemical substituents, cellular or acellular components, and/or metabolites of probiotic microorganisms (i.e. the weight of the metabolite), honey, hive products, biosurfactants, prebiotics, plant extracts, and vitamin D.” Therefore, the concentration is a derived index by calculating the product of the weight of the metabolite and the inverse of the weight of the microorganism, as the composition is a probiotic organism (See Para[0118] “the probiotic organism(s) employable for use in this invention may not be living; moreover, they may, in fact, include micro-organisms or fractions thereof that would normally be considered commensal or even pathogenic to the human host”. Therefore, the probiotic organism(s) include microorganisms).).
With regards to Claim 5, Berkes teaches
obtain a weight of the metabolite (See Para[0075] ““In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition) of at least about 1 μg/g, 5 μg/g, 20 μg/g, 50 μg/g, 0.1 mg/g, 0.5 mg/g, 1 mg/g, 5 mg/g, 10 mg/g, 50 mg/g, 100 mg/g, or 500 mg/g, wherein the ingredient is selected from the group consisting of extracts of microorganisms, chemical substituents, cellular or acellular components, and/or metabolites of probiotic microorganisms (i.e. the weight of the metabolite)”) specified about a culture solution of the microorganism in a vessel (See Para[0069] “During culture of any organism for use in the invention (i.e. specified about the culture solution in the vessel as the culture solution is grown in a container or vessel), cultures may or may not be grown to maximal plateau growth phase at which time they may be harvested for maximal biofilm production.” The organism that is used in a culture solution in Berkes is a microorganism, See Para[0118] “the probiotic organism(s) employable for use in this invention may not be living; moreover, they may, in fact, include micro-organisms or fractions thereof that would normally be considered commensal or even pathogenic to the human host”. Therefore, the probiotic organism(s) include microorganisms),
obtain a weight of the microorganism (See Abstract “the subject invention provides anti-biofilm compositions comprising one or more probiotic organisms”, where the weight of the composition is defined, see Para[0075] “In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition)”. Therefore, the weight of the microorganism, which is the probiotic organism (See Para[0118] “the probiotic organism(s) employable for use in this invention may not be living; moreover, they may, in fact, include micro-organisms or fractions thereof that would normally be considered commensal or even pathogenic to the human host”. Therefore, the probiotic organism(s) include microorganisms), is obtained.) specified about the culture solution (See Para[0069] “During culture of any organism for use in the invention (i.e. specified about the culture solution in the vessel as the culture solution is grown in a container or vessel), cultures may or may not be grown to maximal plateau growth phase at which time they may be harvested for maximal biofilm production.”),
derive an index about the weight of the metabolite using the weight of the metabolite and an inverse of the weight of the microorganism (See Para[0075] “In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition) of at least about 1 μg/g, 5 μg/g, 20 μg/g, 50 μg/g, 0.1 mg/g, 0.5 mg/g, 1 mg/g, 5 mg/g, 10 mg/g, 50 mg/g, 100 mg/g, or 500 mg/g, wherein the ingredient is selected from the group consisting of extracts of microorganisms, chemical substituents, cellular or acellular components, and/or metabolites of probiotic microorganisms (i.e. the weight of the metabolite), honey, hive products, biosurfactants, prebiotics, plant extracts, and vitamin D.” Therefore, the concentration is a derived index about the weight of the metabolite by using the weight of the metabolite and the inverse of the weight of the microorganism, as the composition is a probiotic organism (See Para[0118] “the probiotic organism(s) employable for use in this invention may not be living; moreover, they may, in fact, include micro-organisms or fractions thereof that would normally be considered commensal or even pathogenic to the human host”. Therefore, the probiotic organism(s) include microorganisms).).
Berkes is silent to the language of
an information processing apparatus, wherein
the information processing apparatus is configured to
and output the index.
Fujita teaches
an information processing apparatus, wherein (See Fig. 29, the entire Figure)
the information processing apparatus is configured to
and output the index (See Fig. 29, the entire Figure is the information processing apparatus, where Fig. 29 contains the display unit 45. See also Para[0140] “The concentration of the biogenic particles 101 in the collected particles 100, which is calculated by the calculation unit 411, is output from the control unit 41 to the display unit 45.” Therefore, the index, which is the concentration, is calculated and outputted.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Berkes wherein an information processing apparatus, wherein the information processing apparatus is configured to and output the index is done like in Fujita in order to have a well-defined structure for the apparatus of the method in Berkes that can output the index in Berkes in an efficient and compartmentalized manner.
Claim(s) (3-4, 7-8, and 11-12) is/are rejected under 35 U.S.C. 103 as being unpatentable over Berkes and Fujita as applied to claim (1, 5, 9) above, and further in view of Lewis (US 20200010870 A1).
With regards to Claims 3, 7, and 11, Berkes and Fujita teach the limitations of Claim 1, 5, and 9. Berkes further teaches
the weight of the metabolite (See Para[0075] “In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition) of at least about 1 μg/g, 5 μg/g, 20 μg/g, 50 μg/g, 0.1 mg/g, 0.5 mg/g, 1 mg/g, 5 mg/g, 10 mg/g, 50 mg/g, 100 mg/g, or 500 mg/g, wherein the ingredient is selected from the group consisting of extracts of microorganisms, chemical substituents, cellular or acellular components, and/or metabolites of probiotic microorganisms (i.e. the weight of the metabolite)”) is specified about the culture solution (See Para[0069] “During culture of any organism for use in the invention (i.e. specified about the culture solution), cultures may or may not be grown to maximal plateau growth phase at which time they may be harvested for maximal biofilm production.”).
Berkes and Fujita are silent to the language of
on which quenching processing for stopping metabolic reaction of the microorganism has been performed.
Lewis teaches
on which quenching processing for stopping metabolic reaction of the microorganism has been performed (See Para[0050] “After incubation (i.e. of the microorganism, See Abstract “Devices, methods and systems are for identifying the cell type of an unknown microorganism”), the growth medium is analyzed to determine its metabolite content, which is its metabolic profile. In one embodiment, after a selected incubation time, the growth medium is quenched to stop metabolism (i.e. on which quenching processing for stopping metabolic reaction of the microorganism has been performed).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify Berkes and Fujita wherein on which quenching processing for stopping metabolic reaction of the microorganism has been performed like in Lewis in order to apply an efficient mechanism to cease metabolic activities.
With regards to Claims 4, 8, and 12, Berkes and Fujita teach the limitations of Claim 3, 7, and 11. Berkes further teaches
the weight of the microorganism (See Abstract “the subject invention provides anti-biofilm compositions comprising one or more probiotic organisms”, where the weight of the composition is defined, see Para[0075] “In certain embodiments, the therapeutic composition comprises an ingredient at a concentration (weight of the ingredient/weight of the composition)”. Therefore, the weight of the microorganism, which is the probiotic organism (See Para[0118] “the probiotic organism(s) employable for use in this invention may not be living; moreover, they may, in fact, include micro-organisms or fractions thereof that would normally be considered commensal or even pathogenic to the human host”. Therefore, the probiotic organism(s) include microorganisms), is obtained.) is specified about the culture solution on which the quenching processing has not been performed (See Para[0069] “During culture of any organism for use in the invention (i.e. is specified about the culture solution), cultures may or may not be grown to maximal plateau growth phase at which time they may be harvested for maximal biofilm production.” As Berkes does not mention quenching for the culture, quenching on the culture solution has not been performed.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOSTOFA AHMED HISHAM whose telephone number is (571)272-8773. The examiner can normally be reached Monday - Friday, 7:00 a.m. - 4 p.m. ET.
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/MOSTOFA AHMED HISHAM/Examiner, Art Unit 2857
/Catherine T. Rastovski/Supervisory Primary Examiner, Art Unit 2857
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