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 .
Status of the Claims
Claims 1-18 are pending and examined herein.
No claims are canceled.
Priority
As detailed on the date filing receipt, the application claims priority as early as 30 July 2020. At this point in examination, all claims have been interpreted as being accorded this priority date as the effective filing date.
Withdrawn Objections and/or Rejections
The objection to the specification is withdrawn in view of amendment correcting the spelling of Graves’ disease.
The objection to claims 1-2, 4-5, and 12-17 for lack of a conjunction is withdrawn in view of addition of the conjunction “and” in all instances.
The objection to claim 11 is withdrawn in view of the amendment to add an article before “storing database.”
The rejections under 35 USC 112(b) is withdrawn in view of amendment clarifying the claims are directed to a method and clarified antecedence.
The rejection under 35 USC 112(b) regarding lack of clarity of “similar” is withdrawn in view of persuasive argument (pg. 10) and indication the specification discloses the most similar change is the smallest difference in numerical values indicating the health condition.
The following rejections constitute the complete set of rejections for the instant claims.
Claim Rejections - 35 USC § 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.
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.
Claim 9 is 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.
Claim 9 is a method claim which claims a system component in the form of a sequencer. Because the claims are directed to a process comprising actions and not tangible products (MPEP 2106.03), the inclusion of the sequencer makes the 101 category of the invention unclear. Amendment removing this claim, or a similar amendment, could overcome the rejection.
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 1-18 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)). The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than the abstract idea of selecting a bacterium.
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
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 (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
As explained above, the claims are directed to a method (claims 1-18), which falls within one of the categories of statutory subject matter. [Step 1: Yes]
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 (MPEP 2106.04(a-c))?
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Mental processes, defined as concepts practically performed in the human mind such as steps of observing, evaluating, or judging information, recited in claim 1 including constructing a database and selecting a bacterium. A database is a list of related information and a person can practically perform this step using pen and paper. Furthermore, the human mind is practically equipped to make a selection.
Claim 2 recites analyzing the health condition and constructing a database, which are further mental processes as data analysis and formatting (in the form of a database) are mental processes.
Claim 3 recites updating the database, which is interpreted as a mental process as the human mind can add information to a list of data.
Claim 4, in addition to previously recited abstract ideas, recites recording data, which a person can do with the help of pen and paper, searching a database, confirming changes, and making a selection, all of which are practically performed mentally.
Claim 7 recites identification of bacteria, which is a mental process of evaluation and judgment, and measurement could, under a broadest reasonable interpretation, fall under a mental process of comparing data.
Claim 10 recites additional information about the infection data in the database, where data in the database is abstract.
Claims 12-13 recite the elements of claim 4 addressed above.
Claim 14-18 recite the elements of claim 5 addressed above.
Hence, the claims explicitly recite numerous elements that, individually and in combination,
constitute abstract ideas. The claims must therefore be examined further to determine whether they
integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A: Yes]
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Independent claim 1 recites additional elements that are not abstract ideas: a bacterial flora bank and supplying the bacterium selected.
Claim 2 recites storing bacteria and constructing a flora bank. Claim 3 recites updating the flora bank. Claim 4 recites storing bacteria. Claims 5 and 14-18 recite isolating, proliferating, and supplying bacteria. Claim 6 recites additional information about the bacteria. Claims 8-9 recite metagenomic analyses. Claim 11 recites non-volatile storage memory.
Claim elements including constructing, storing, and updating the flora bank as well as treatment of the bacteria are interpreted as necessary steps for the steps of data analysis and selecting a bacterium. Therefore, these are data gathering elements interpreted as insignificant extra solution activity (MPEP 2106.05(g)).
Supplying the bacteria is interpreted as applying the selection step stated generally, and thus is interpreted as mere instruction to apply the exception (MPEP 2106.05(f)).
Steps related to sequencing are interpreted as data collection step for the analysis and selecting, and thus also interpreted as insignificant extra solution activity (MPEP 2106.05(g)).
The storing on non-volatile memory is interpreted as storing the database on a computer. Mere instructions to apply the abstract idea using a computer, and therefore the claim does not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; and MPEP 2106.05(f)). [Step 2A Prong Two: No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Additional elements recited in the claims are: a bacterial flora bank and supplying the bacterium selected (claim 1), storing bacteria and constructing a flora bank (claim 2), updating the flora bank (claim 3), storing bacteria and selecting a bacterium (claim 4), isolating, proliferating, and supplying bacteria (claim 5), additional information about the bacteria (claim 6), metagenomic analysis and sequencing (claims 8-9) and non-volatile storage memory (claim 11).
Terveer (Clinical Microbiology and Infection 23: 924-930, 2-17; previously cited on the 21 October 2025 PTO-892 form) teaches at least stool banking and a related database, including monitoring outcomes and donor screening (pg. 927, col. 2, second and third paragraphs), which are interpreted as reading on the construction and maintenance of the required database and bank. Terveer teaches a product for treatment (abstract), where treating would require supplying the product. Terveer teaches culturing of the bacteria from the sample (Table 2, “Laboratory Screening Faeces). Meanwhile, Thomas (Future Microbiology 10(9): 1-20, 2015; ; previously cited on the 21 October 2025 PTO-892 form) teaches 16S and metagenomic sequencing (pg. 5, col. 2, first paragraph) of biobanked samples.
Therefore, the recited additional elements, alone or in combination with the judicial exceptions, do not appear to provide an inventive concept. [Step 2B: No]
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole,
are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not
constitute significantly more than the abstract idea, so the claims are rejected under 35 USC § 101 as
being directed to non-statutory subject matter.
Response to the 18 March 2026 Applicant Remarks
Applicant remarks state, regarding analysis at Step 2A Prong Two of analysis in the 101 framework, that “the claims refer to a defined, multi-step database-implemented processing pipeline that produces a specific result. The claimed combination of steps constitutes a practical application of computer technology that improves selection and supply of bacterium to treat health conditions, a result that is not achievable through purely mental steps” (pg. 12, third paragraph). This argument is unpersuasive. At Step 2A Prong Two, it is determined if the judicial exceptions are integrated into a practical application by an additional element (MPEP 2106.04(d)). Here, the claims recite judicial exceptions in the form of data associations and related analysis, which are abstract steps in the form of mental processes – data observation and evaluation – or mathematical concepts – numerical relationships between variables. The elements in addition to the abstract ideas are storing and updating information in a database, a bacteria floral bank, supplying a bacterium, and isolating and proliferating an isolated bacterium from the bacterial floral bank. The “processing pipeline” is understood as data processing steps of data comparison based on stored data and bacteria followed by supplying a selected bacterium to a subject.
It is true that the result is not achievable through purely mental steps. However, at Step 2A Prong Two, the additional elements are analyzed to determine if they provide a practical application. The data and bacteria being stored are interpreted as insignificant extra-solution activity in the form of collecting data from the data comparison and analysis to be performed (MPEP 2106.05(g)). The recited application of computer technology (pg. 12, third paragraph) appears to be limited to storing information in a database, which falls within the state of the art for computer use. Finally, supplying a bacterium, which has been isolated and proliferated, amounts to instruction to apply the exception (MPEP 2106.05(f)), where the bacteria is selected is provided to a subject. A treatment of a health condition is not being affected, as the bacterium is merely supplied to a subject and not administered as a particular treatment for a particular condition. MPEP 2106.04(d)(2) pertains.
At Step 2B, applicant remarks state “the additional elements of the claims, individually and as an ordered combination, amount to significantly more than any alleged abstract idea” (pg. 12, fourth paragraph), further asserting “functional constraints on how the bacterium is supplied to the subject: changes in health conditions of donors of bacterial flora must be associated with changes in the bacterial flora provided by the donors and the bacterium selected for the recovery of a health condition of the test subject must be based on the changes in the health condition of the test subject” (pg. 12, last paragraph to pg. 13, first paragraph), analyzing a relationship between the bacteria and donor condition, searching the database, and selecting the database (pg. 13, second paragraph). The supply of the bacteria to the subject is not particularly stated and thus interpreted generally as applying the abstract idea as described above, and the steps of determining changes, searching the database, and selecting a bacterium are all abstract steps and thus not evaluated at Step 2B of 101 analysis. Terveer (Clinical Microbiology and Infection 23: 924-930, 2-17; previously cited on the 21 October 2025 PTO-892 form) teaches at least stool banking and a related database, including monitoring outcomes and donor screening (pg. 927, col. 2, second and third paragraphs), which are interpreted as reading on the construction and maintenance of the required database and bank. Terveer teaches a product for treatment (abstract), where treating would require supplying the product. Terveer teaches culturing of the bacteria from the sample (Table 2, “Laboratory Screening Faeces), where isolating and proliferating bacteria is interpreted as reading on culturing bacteria. Meanwhile, Thomas (Future Microbiology 10(9): 1-20, 2015; previously cited on the 21 October 2025 PTO-892 form) teaches 16S and metagenomic sequencing (pg. 5, col. 2, first paragraph) of biobanked samples. Therefore, the elements in addition to the abstract ideas are interpreted as conventional alone and in combination.
Thus, the rejection under 35 USC 101 is maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5-12, 14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jørgensen (Transfusion 59(9): 2776-2782, 2019; previously cited on the 14 April 2022 IDS form) in view of Bibbo (Journal of Clinical Medicine 9(1757):1-14, 2020; previously cited on the 30 August 2022 IDS form ) and Santiago (US 2020/0164000 A1; previously cited on the 14 April 2022 IDS form).
Claim 1 recites a step of constructing a database comprising data in which the changes in the health condition of donors of bacterial flora are mutually associated with the changes in the provided bacterial flora, and a bacterial flora bank in which the provided bacterial flora is stored.
Jørgensen teaches stool banks (pg. 2778, col. 2, second paragraph) and a database including patient information (pg. 2778, col. 2, first paragraph). Jørgensen teaches screening bacteria communities for treatment of recurrent Clostridioides difficile infection (pg. 2777, col. 2, third paragraph).
Claim 1 recites a step of selecting a bacterium necessary for the recovery of the health condition of a test subject based on the changes in the health condition of the test subject by using the above-mentioned database.
Jørgensen does not teach selection of specific bacteria for treatment of a condition, rather treatment using a microbiota (pg. 2778, col. 2, second paragraph).
Claim 1 recites a step of supplying the bacterium selected from the bacterial flora bank to the test subject.
Jørgensen teaches “fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridioides difficile infection and is potentially beneficial in other microbiota-related disorders” (abstract).
Santiago teaches a “database of stool donors” (paragraph [423]).
Bibbò teaches “selecting specific enteric bacterial strains with bacterial cultures from healthy donors to prepare a stool substitute blend might be a winning strategy to cure recurrent and antibiotic-resistant C. difficile colitis” (pg. 7, third paragraph). Bibbò also teaches bacterial transplant recipients have shown changes in microbial profiles and shifts in microbiota composition toward the profile of the donor (pg. 3, first paragraph).
Claim 2 recites a step of analyzing the health condition of the donors of the bacterial flora and the provided bacterial flora, and constructing a database comprising data in which the changes in the health condition of the donors of the bacterial flora are mutually associated with the changes in the provided bacterial flora.
Jørgensen teaches laboratory processing of donor feces (pg. 2778, col. 1, last paragraph) and health screening for health-related criteria (pg. 2778, col. 1, first paragraph).
Claim 2 recites a step of storing the provided bacterial flora and constructing a bacterial flora bank.
Jørgensen teaches storing the stools in banks where the samples have been screened and processed and are then ready for clinical use (pg. 2778, col. 2, third paragraph).
Claim 5 recites a step of isolating a bacterium selected from the bacterial flora bank, a step of proliferating the isolated bacterium, and a step of supplying the proliferated bacterium to the test subject.
Santiago teaches bacterial strains isolated and proliferated from a fecal sample (pg. 3, paragraph [37]).
Claim 6 recites the bacterial flora is a bacterial flora selected from the group consisting of intestinal bacterial flora, oral bacterial flora, skin bacterial flora and vaginal bacterial flora.
Jørgensen and Bibbo teach stool or fecal flora, which can reasonably be expected to reflect intestinal flora. Santiago explicitly teaches intestinal microbiota (pg. 3, col. 1, paragraph [29]).
Claim 7 recites the analysis of the bacterial flora comprises identification of bacteria contained in the bacterial flora and measurement of an abundance ratio thereof.
Santiago teaches calculation of relative abundance of bacteria in a community (paragraph [25]).
Claim 8 recites the analysis of the bacterial flora is 16s metagenome analysis or 23s metagenome analysis.
Santiago teaches identifying characteristics of a bacterial isolate using 16S rRNA and entire genome sequences (paragraph [38]).
Claim 9 recites a sequencer for the 16s metagenome analysis or the 23s metagenome analysis.
Santiago teaches Illumina sequencing of 16S data (paragraph [406]), which would require an Illumina sequencer.
Claim 10 recites the health condition is a condition of infection and parasitic disease, tumor, endocrine and metabolism disease, psychiatric and nerve system disease, circulatory disease, respiratory disease, gastrointestinal disease, skin and subcutaneous tissue disease, renal genitourinary tract disease, autoimmune disease, or collagen disease.
Jørgensen teaches health conditions including metabolic syndrome and multidrug resistant infections (pg. 2777, col. 2, second paragraph).
Bibbò teaches application of fecal transplant to gastrointestinal, nervous system, skin, and gynecological diseases (pg. 1, last paragraph).
Santiago teaches infectious disease, autoimmune disease, and neurological disease (paragraph [5]).
Claim 11 recites a non-volatile storage memory for storing the database.
Santiago teaches use of a database and implementation on a computer (paragraph [63]), which may be implied to have memory for storing the database.
Claim 12 recites a combination of claims 2 and 4, which are taught by Jørgensen, Bibbò and Santiago as explained above.
Claim 14 recites a combination of claims 2 and 5, which are taught by Jørgensen, Bibbò and Santiago as explained above.
Claim 17 recites a combination of claims 12 and 5, which are taught by Jørgensen, Bibbò and Santiago as explained above.
Combining Jørgensen, Bibbò and Santiago
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the work of Bibbò, which teaches selecting specific strains of bacteria for treating dysbiosis, with Jørgensen, which teaches fecal transplant including donor screening, a database, and storage of the “final package” for administration (pg. 3, col. 2, first paragraph). Jørgensen does not teach use of specific strains, but Bibbò teaches at least the possibility that specific strains, or blends of specific strains, may be a good treatment for C. difficile colitis (pg. 7, third paragraph). Furthermore, combination with Santiago, which teaches a stool donor database and genomic abundance metrics, would be desirable because Santiago teaches abundance differences in patients with and without a relevant health condition (pg. 1, paragraphs [11-12]), while Bibbò alludes to abundance differences in certain bacteria as being different in patients with and without a gut condition (pg. 8, first paragraph). Jørgensen, Bibbò and Santiago are all directed to the field of fecal microbiota transplantation, and their combination would be expected to succeed. Therefore, the invention is prima facie obvious.
Claims 3-4, 13, 15-16, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Jørgensen in view of Bibbo and Santiago as applied to claims 1-2, 5-12, 14, and 17 above and further in view of Terveer (Clinical Microbiology and Infection 23: 924-930, 2-17; previously cited on the 21 October 2025 PTO-892 form).
Claim 3 recites a step of updating the database and the bacterial flora bank by repeating steps of claim 2.
Jørgensen, Bibbò, and Santiago teach a database including patient and donor information but do not teach updating the database.
Terveer teaches “systematic follow-ups of both patients and donors” including collection of additional feces and a national database of donor information and fecal samples (pg. 926, col. 1, last paragraph).
Claim 4 recites a step of analyzing the health condition of the test subject and the bacterial flora of the test subject, and recording data in which the changes in the health condition of the test subject are mutually associated with the changes in the bacterial flora of the test subject on the database.
Bibbò teaches analyzing the variety and abundance of species in the gut microbiota with respect to chronic diseases, where low diversity is correlated with gut dysbiosis (pg. 2, third paragraph).
Claim 4 recites a step of storing the bacterial flora of the test subject in the bacterial flora bank.
Jørgensen teaches stool banks (pg. 2778, col. 2, second paragraph), as does Bibbò (abstract).
Claim 4 recites a step of searching the database for changes in the health condition of the donor which are the same as or similar to the changes in the health condition of the test subject.
Terveer teaches a database of biosamples, donor information, and collection of clinical data such as adverse events (pg. 927, col. 2, second and third paragraphs) and Bibbò teaches data showing changes in gut microbiota shifts toward the donor (pg. 3, first paragraph).
Claim 4 recites a step of confirming changes in the bacterial flora of the donor associated with the obtained changes in the health condition of the donor.
Terveer teaches systematic follow-up with the donor and patients after the procedure, where confirming changes reads on following up on the patient condition following treatment.
Claim 4 recites a step of selecting a bacterium necessary for the recovery of the health condition of the test subject.
Bibbò teaches “selecting specific enteric bacterial strains with bacterial cultures from healthy donors to prepare a stool substitute blend might be a winning strategy to cure recurrent and antibiotic-resistant C. difficile colitis” (pg. 7, third paragraph), where the health condition is C. difficile colitis.
Claim 13 recites a combination of claims 3 and 4, which are taught by the combination of Jørgensen, Bibbò, Santiago, and Terveer as explained above.
Claim 15 recites a combination of claims 3 and 5, which are taught by the combination of Jørgensen, Bibbò, Santiago, and Terveer as explained above.
Claim 16 recites a combination of claims 4 and 5, which are taught by the combination of Jørgensen, Bibbò, Santiago, and Terveer as explained above.
Claim 18 recites a combination of claims 13 and 5, which are taught by the combination of Jørgensen, Bibbò, Santiago, and Terveer as explained above.
Combining Jørgensen, Bibbò, Santiago, and Terveer
An invention would have been obvious to one of ordinary skill in the art if some motivation in the prior art would have led that person to modify prior art reference teachings to arrive at the claimed invention prior to the effective filing date of the invention. One would have been motivated to combine the work of Terveer with the previously combined art because Terveer teaches a database including information about “coding, tracking, and tracing” of biosamples and a related database including “biovigilance” for “adverse events” (pg. 927, col. 2, second paragraph). Terveer teaches following up after the procedure to determine changes after the treatment and samples remain stored for further analysis (pg. 927, col. 2, second paragraph). One would be motivated to combine the work of Terveer with the previously combined work because Terveer teaches such a database with follow up information because “an important aim… is to recognize the complications of FMT” (pg. 927, col. 2, second paragraph), which would be realized by updating information about the treatment. Jørgensen, Bibbò, Santiago, and Terveer are all directed to the field of fecal microbiota transplantation, and their combination would be expected to succeed. Therefore, the invention is prima facie obvious.
Response to the 18 March 2026 Applicant Remarks
Applicant remarks state “the focus on the health conditions of the donor of the bacterial flora and the health conditions of the test subject is not disclosed by the cited references” (pg. 14, third paragraph). Particularly, remarks state “Bibbo et al. is completely unconcerned with comparing changes in the health status of the microbiota donor with health changes of the test subject” (pg. 14, last paragraph to pg. 15, first paragraph) and Santiago “does not involve assessing whether the health conditions of fecal donors and test subjects are similar” (pg. 15, second paragraph). Applicant remarks state one would not have arrived at the combination of construction of a database to monitor health changes in donors of bacterial flora to allow for selection of bacterium that come from a donor with similar changes in health conditions as a test subject (pg. 15, second paragraph). However, Bibbo teaches “FMT recipients have shown changes in microbial profiles and shifts in the gut microbiota composition towards a profile similar to that of the healthy donor” (pg. 3, first paragraph), which is interpreted as comparing changes in the healthy donor to apply the gut bacteria to a transplant recipient. Therefore, Bibbo is considered to teach selecting bacteria based on a donor to obtain similar changes (i.e., towards a similar microbiota profile) in a subject, and thus a relationship between application of the bacteria in a the donor, where the donor is healthy and exhibits a healthy profile, can be applied to the subject to obtain a similar health via a healthy profile. Together with Santiago’s database of healthy donors, where healthy donors have bacteria associated with a healthy donor condition, and the condition of interest is gut dysbiosis (abstract), and Teveer’s updating the database in the form of “systematic follow-ups of both patients and donors” including collection of additional feces and a national database of donor information and fecal samples (pg. 926, col. 1, last paragraph), is interpreted as teaching the required relationship between donor health for a condition and bacteria associated with donor health, and application of the bacteria to the subject to attempt to obtain a similar microbial profile and thus health.
Applicant remarks also state the applied prior art “does not involve the use of that healthy donor's sample to treat the subject” (pg. 15, second paragraph). It is noted that while the instant combination is interpreted as teaching treatment using a donor sample to obtain a similar health condition in a subject – in particular in view of Bibbo and Santiago as discussed above - treatment is not required by the instant claims. Bacteria are supplied to the subject because on desired changes mirroring those in the donor, but treatment is not required in the instant claims, as discussed in the rejection under 35 USC 101 above.
In conclusion the rejection under 35 USC 103 is maintained.
Conclusion
The follow art is made of record: Borody (JP 2019194202 A) teaches fecal microbiota transplantation, including delivery of a bacterium for treatment from a bank of donor bacteria.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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R.J.K./
Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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