Prosecution Insights
Last updated: October 04, 2026
Application No. 18/855,498

METHODS OF TREATING AND DIAGNOSING FATTY LIVER DISEASE

Non-Final OA §102§103§112
Filed
Oct 09, 2024
Priority
Apr 19, 2022 — provisional 63/332,573 +1 more
Examiner
FERNANDEZ, SUSAN EMILY
Art Unit
Tech Center
Assignee
National And Kapodistrian University Of Athens
OA Round
1 (Non-Final)
52%
Grant Probability
Moderate
1-2
OA Rounds
1y 9m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 52% of resolved cases
52%
Career Allowance Rate
295 granted / 562 resolved
-7.5% vs TC avg
Strong +61% interview lift
Without
With
+60.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
44 currently pending
Career history
601
Total Applications
across all art units

Statute-Specific Performance

§101
6.3%
-33.7% vs TC avg
§103
41.0%
+1.0% vs TC avg
§102
10.4%
-29.6% vs TC avg
§112
31.8%
-8.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 562 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . The amendment filed August 6, 2026, has been received and entered. Claims 14-18 are cancelled. Claims 1-13 are pending. Election/Restrictions Applicant’s election of Group I, claims 1-9, in the reply filed on August 6, 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claim 10 has been amended to require treating nonalcoholic fatty liver disease (NAFLD) comprising administering to a subject an agent that inhibits or eradicates actinomyces to treat NAFLD. Therefore, claims 10-13 are directed to Group I, the elected invention. Accordingly, claims 1-13 are examined on the merits. Claim Objections Claims 1-13 are objected to because of the following informalities: Claims 1, 4, and 10-13 are objected to because they recite “actinomyces.” The first letter of the term should be capitalized (i.e., “Actinomyces”). Since claim 1 is objected to, then its dependent claims, claims 2-9, are objected to. Claim 5 is objected to because the first letter of the recitation “Penicillin” should be in lowercase. Claim 7 is objected to because the first letter of the recitation “prevotella” should be capitalized. Claim 10 is objected to because it recites “NALFD” in line 5, and “NADLD” in the last line. Both of these recitations should be changed to the abbreviation “NAFLD” as in line 2. Claim 11 is objected to because it recites “NALF.” This recitation should be changed to the abbreviation “NAFL.” Claim 13 is objected to because the recitation “actinomyces” should be italicized. As pointed out above, the first letter of the term should be capitalized. Thus, claim 13 should recite “Actinomyces.” 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 4-6 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. Claim 4 recites the limitation "the agent that inhibits, redistributes, reduces or eradicates actinomyces." There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 does not recite an “agent that inhibits, redistributes, reduces or eradicates actinomyces,” and instead recites an “agent that inhibits or eradicates actinomyces.” Parent claim 1 does not recite that the “agent that inhibits or eradicates actinomyces” alternatively redistributes or reduces actinomyces (Actinomyces). Since claim 4 is indefinite, then its dependent claims, claims 5 and 6, are rendered indefinite. Thus, claims 4-6 are rejected under 35 U.S.C. 112(b). For the purpose of applying prior art, “the agent that inhibits, redistributes, reduces or eradicates actinomyces” of claim 4 is being interpreted as the “agent that inhibits or eradicates actinomyces.” Notice Re: Prior Art Available Under Both Pre-AIA and AIA In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 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. 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 1-3, 7, and 8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kovarik (US 2019/0117709. Listed on IDS filed 8/6/26). Kovarik discloses a method for treating non-alcoholic fatty liver disease (NAFLD) in a subject in need thereof that includes administering a composition including a therapeutically effective amount of Prevotella (paragraph [0031]). Prevotella is directed to an ‘agent that inhibits or eradicates [A]ctinomyces,’ specifically to the agent of instant claim 7. Therefore, Kovarik anticipates instant claims 1 and 7. Regarding instant claim 2, Kovarik points out that non-alcoholic fatty liver disease is a condition ranging from benign lipid accumulation in the liver (steatosis) to steatosis combined with inflammation, i.e., non-alcoholic steatohepatitis (NASH) (paragraph [0014]). Also, Kovarik discloses that their invention is directed in various embodiments to a way to modify the microbiota to treat hepatic steatosis (paragraph [0033]). Therefore, treating NAFLD of Kovarik includes treating nonalcoholic fatty liver (i.e. hepatic steatosis). As such, instant claim 2 is anticipated. Regarding instant claim 3, Kovarik discloses that their invention reduces the likelihood of developing non-alcoholic steatohepatitis (NASH) in an individual diagnosed with non-alcoholic fatty liver disease (abstract). Also, Kovarik points out that non-alcoholic fatty liver disease is a condition ranging from benign lipid accumulation in the liver (steatosis) to steatosis combined with inflammation, i.e., non-alcoholic steatohepatitis (NASH) (paragraph [0014]). The instant specification defines the term “treating” as encompassing slowing down or stopping the progression of a symptom or condition (paragraph [0034]). Therefore, in reducing the likelihood of NASH in an individual according the invention of Kovarik, as well as treating NAFLD (which encompasses the most severe form, NASH), then NASH is treated, anticipating instant claim 3. Regarding instant claim 8, Kovarik discloses delivering the therapeutic directly to the gastrointestinal tract (paragraph [0076]). Therefore, instant claim 8 is anticipated. Claims 1-4, 6, and 8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Johnson (WO 2020/245214. Listed on IDS filed 10/9/24), as evidenced by Finegold (Antimicrobial Agents and Chemotherapy. 2009. 53(1): 281-286). Johnson discloses a method of treating nonalcoholic steatohepatitis (NASH) or nonalcoholic fatty liver disease (NAFLD) or a symptom thereof in a subject in need thereof, the method comprising administering a therapeutic agent that can be rifaximin (page 4, lines 12-15). Rifaximin is an antibiotic directed to the ‘agent that inhibits or eradicates actinomyces’ of instant claim 4, specifically an antibiotic of instant claim 6. Moreover, as evidenced by Finegold, all strains of Actinomyces tested in their study, specifically three strains of Actinomyces meyeri, four strains of Actinomyces odontolyticus, and three strains of Actinomyces viscosus, are susceptible to rifaximin (Table 1, for Gram-positive non-spore-forming rods; page 285, left column, first paragraph disclosing that other gram-positive non-spore-forming strains of other species were the only strains resistant to rifaximin). Therefore, the evidence provides support for rifaximin being an agent that inhibits or eradicates Actinomyces. As such, Johnson anticipates instant claims 1, 3, 4, and 6 (rifaximin). Regarding instant claim 2, Johnson discloses that NAFLD includes a wide spectrum of liver abnormalities which range from simple steatosis to NASH (page 53, lines 26-27). Given the wide spectrum of NAFLD, then treating NAFLD or a symptom thereof in a subject of the invention of Johnson includes treating nonalcoholic fatty liver (NAFL). Thus, instant claim 2 is anticipated. Regarding instant claim 8, Johnson discloses that the rifaximin can be delivered in the form of a pharmaceutical composition that includes a therapeutically effective amount of rifaximin (page 44, lines 17-21). The pharmaceutical composition may be suitable for oral administration and can be presented as tablets (page 46, lines 7-8). The tablets can be uncoated or coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period (page 48, lines 27-28). In being provided in a tablet with delayed disintegration and absorption in the gastrointestinal tract, then the rifaximin (directed to the claimed agent) is released into the gastrointestinal system of the subject, anticipating instant claim 8. Claims 1-4 and 6-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Smith (WO 2021/142347), as evidenced by Finegold (Antimicrobial Agents and Chemotherapy. 2009. 53(1): 281-286). Smith discloses a method for treating non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) in a subject in need thereof, the method comprising administering to the subject a pharmaceutically active dose of a therapeutic composition comprising a preparation of uncultured fetal bacteria, a bacterial mixture, or live non-pathogenic fecal bacteria (paragraphs [0007]-[0009]). The pharmaceutical composition that is administered can include a bacterial isolate comprising a species of Prevotella (paragraph [0065]). Also, the uncultured fecal bacteria can comprise Prevotella such as Prevotella oralis and Prevotella ruminicola (paragraphs [0086]-[0087]). Prevotella is directed to an ‘agent that inhibits or eradicates [A]ctinomyces,’ specifically to the agent of instant claim 7. Therefore, for the embodiment of Smith in which the therapeutic composition comprises Prevotella, Smith anticipates instant claims 1, 3, and 7. In one embodiment, Smith discloses a method for treating one or more symptoms of non-alcoholic steatohepatitis (NASH) in a subject in need thereof comprising administering to the subject: (i) one or more bacterial isolates; (ii) a preparation of uncultured fecal bacteria; and (iii) one or more antibiotics (paragraph [0336]). The antibiotic(s) can be tetracycline, doxycycline, amoxicillin, meropenem, clarithromycin, and/or rifaximin (paragraphs [0258]-[0259]). These antibiotics are directed to the ‘agent that inhibits or eradicates [A]ctinomyces’ of instant claim 4, as well as being amongst the antibiotics recited in instant claim 6. Moreover, as evidenced by Finegold, all strains of Actinomyces tested in their study, specifically three strains of Actinomyces meyeri, four strains of Actinomyces odontolyticus, and three strains of Actinomyces viscosus, are susceptible to rifaximin (Table 1, for Gram-positive non-spore-forming rods; page 285, left column, first paragraph disclosing that other gram-positive non-spore-forming strains of other species were the only strains resistant to rifaximin). Therefore, the evidence provides support for rifaximin being an agent that inhibits or eradicates Actinomyces. As such, the method of Smith for treating NASH comprising administering one or more antibiotics also anticipates instant claims 1, 3, 4, and 6 (tetracycline, doxycycline, amoxicillin, meropenem, clarithromycin, and rifaximin). Regarding instant claim 2, Smith indicates that NASH is defined as the presence of ≥5% hepatic steatosis, which is accumulation of fat deposits in the liver (paragraph [0262]). Therefore, in treating NAFLD, then nonalcoholic fatty liver (NAFL) is treated, anticipating instant claim 2. Regarding instant claims 8 and 9, the pharmaceutical composition of Smith can be formulated for delivery to the GI tract which includes the duodenum (paragraph [0168]). For example, the composition can be formulated for delivery of one or more active agents to a subsection of the small intestine, such as the duodenum (paragraph [0168]). Smith teaches a modified-release formulation which can release at least 60% of the bacterial mixture (and optionally additional therapeutic agents) in the small intestine, such as the duodenum of the small intestine (paragraph [0175]). Therefore, instant claims 8 and 9 are anticipated. 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. 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. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kovarik. As discussed above, Kovarik anticipates claims 1-3, 7, and 8. Kovarik differs from claim 9 in that Kovarik does not expressly disclose that Prevotella (directed to the claimed agent) is released into duodenum of the subject. However, Kovarik discloses that preferably, the Prevotella that is administered has been modified, e.g. by CRISPR-Cas, in a manner that reduces the effect of at least one of the virulence factors of such bacteria (paragraph [0031]). Also, Kovarik discloses that certain aspects of the invention are directed to the modification of particular bacteria using CRISPR-Cas and/or Cpfl systems to provide bacteria having the ability to survive the conditions in the duodenum of the small intestine (paragraph [0059]). Before the effective filing date of the claimed invention, it would have been prima facie obvious to apply that teaching of Kovarik to the embodiment of Kovarik of treating Prevotella for the treatment of NAFLD since Kovarik recognizes it for other embodiments of their invention. In doing so, then the Prevotella had to be released into the duodenum of the small intestine of the subject in order to benefit from the ability conferred to the Prevotella of surviving the conditions in the duodenum. Therefore, instant claim 9 is rendered obvious. Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson (as evidenced by Finegold) in view of Smith (WO 2021/142347). As discussed above, Johnson (as evidenced by Finegold) anticipates claims 1-4, 6, and 8. Johnson differs from claim 7 in that Johnson does not expressly disclose that the agent that is administered comprises Prevotella. Johnson differs from claim 9 in that Johnson does not expressly disclose that the agent (the rifaximin) is released into duodenum of the subject. However, as discussed above with respect to instant claim 8, Johnson discloses that the rifaximin can be delivered in the form of a pharmaceutical composition that includes a therapeutically effective amount of rifaximin (page 44, lines 17-21). The pharmaceutical composition may be suitable for oral administration and can be presented as tablets (page 46, lines 7-8). The tablets can be uncoated or coated by known techniques to delay disintegration and absorption in the gastrointestinal tract and thereby provide a sustained action over a longer period (page 48, lines 27-28). Smith discloses a method for treating one or more symptoms of non-alcoholic steatohepatitis (NASH) in a subject in need thereof comprising administering to the subject: (i) one or more bacterial isolates; (ii) a preparation of uncultured fecal bacteria; and (iii) one or more antibiotics (paragraph [0336]). The antibiotic(s) can be rifaximin (paragraph [0259]). The bacterial isolate can comprise Prevotella (paragraph [0065]). Also the uncultured fecal bacterial can comprise Prevotella such as Prevotella oralis and Prevotella ruminicola (paragraph [0086]). The pharmaceutical composition of Smith can be formulated for delivery to the GI tract which includes the duodenum (paragraph [0168]). For example, the composition can be formulated for delivery of one or more active agents to a subsection of the small intestine, such as the duodenum (paragraph [0168]). Smith teaches a modified-release formulation which can release at least 60% of the bacterial mixture (and optionally additional therapeutic agents) in the small intestine, such as the duodenum of the small intestine (paragraph [0175]). Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to release the rifaximin into the duodenum of the subject when performing the method of Johnson. One of ordinary skill in the art would have been motivated to do this because Johnson recognizes providing tablets of rifaximin in a form to delay disintegration and absorption in the gastrointestinal tract, and because, for treating NASH as in Smith, a composition can be formulated for delivering the active agents, which can comprise an antibiotic such as rifaximin, into the duodenum which is part of the GI tract. Therefore, instant claim 9 is rendered obvious. Also, before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to additionally administer to the subject a bacterial isolate of Prevotella when performing the method of Johnson. One of ordinary skill in the art would have been motivated to do this because NASH can be treated in a subject by administering a bacterial isolate of Prevotella in combination with administering one or more antibiotics, wherein the one or more antibiotics can be rifaximin, as indicated in Smith. There would have been a reasonable expectation of success in treating NASH by this modification of Johnson because Smith discloses that antibiotics such as rifaximin are a therapeutic agent that can be administered to a subject in addition to Prevotella for the treatment of NASH in a subject. Therefore, instant claim 7 is rendered obvious. Claims 1, 4-6, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (as evidenced by Finegold) in view of Flavell (US 2016/0017409), as evidenced by Steininger (J. Antimicrob. Chemother. 2016. 71: 422-427). As discussed above, Smith (as evidenced by Finegold) anticipates claims 1-4 and 6-9. Smith differs from claim 5 in that Smith does not expressly disclose administering to the subject an agent comprising penicillin G (as the ‘agent that inhibits or eradicates [A]ctinomyces’). Smith discloses that the antibiotic can be a penicillin antibiotic (paragraph [0258]). Flavell discloses a method of treating an inflammatory disease or disorder associated with a secretory antibody-bound bacteria in the microbiota of a subject in need thereof, the method comprising administering to the subject at least one therapy to diminish the number of at least one type of bacteria that is over-represented in the microbiota of the subject, wherein the at least one therapy can be at least one antibiotic (paragraph [0011]). Additionally, the inflammatory disease or disorder can be non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) (paragraph [0011]). The antibiotic can be penicillin g (paragraph [0121]) Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the antibiotic that is administered with penicillin G when performing the method of Smith. It would have been an obvious matter of simple substitution of one known antibiotic, specifically a penicillin antibiotic as taught in Smith, for another antibiotic that is a penicillin antibiotic for the predictable result of treating NASH. There would have been a reasonable expectation of treating NASH by this substitution in Smith because Flavell teaches that penicillin g can be selected as the antibiotic administered to a subject for treating inflammatory diseases/disorders such as NASH. Penicillin G is directed to the ‘agent that inhibits or eradicates [A]ctinomyces’ of instant claims 5 and 6 (penicillin G is one embodiment). Moreover, as evidenced by Steininger, Actinomyces are susceptible to penicillin G. See Table 1 on pages 424-426 of Steininger showing all tested Actinomyces strains being 100% susceptible to penicillin G. Thus, the evidence provides support for penicillin G being directed to an ‘agent that inhibits or eradicates [A]ctinomyces.’ As such, instant claims 1, 4, 5, and 6 (penicillin G) are rendered obvious. Regarding instant claims 10-12, Smith discloses that appropriate subjects for their methods include humans diagnosed as having NAFLD or NAFLD that has progressed to NASH (paragraph [0052]). Therefore, Smith discloses a method of diagnosing and treating NAFLD in a subject in need thereof, comprising diagnosing NAFLD in the subject and administering to the subject an agent that inhibits or eradicates Actinomyces (Prevotella; an antibiotic such as rifaximin; or penicillin G for the method rendered obvious by Smith in view of Flavell) to treat NAFLD, meeting limitations of instant claim 10. However, Smith differs from instant claim 10 in that Smith does not expressly disclose that the subject is diagnosed as having NAFLD or NASH by a method comprising measuring a level of Actinomyces in the gastrointestinal system of the subject, detecting a level of Actinomyces higher than a control level, and determining the presence of NAFLD (or NASH) based on the level of Actinomyces being higher than the control level. Smith points out that, not to be limited by theory, gut microbiota is believed to be involved in altering the balance between pro- and anti-inflammatory signals, which in turn contribute to inflammation that may result in the progression of NAFLD to NASH (paragraph [0266]). Flavell discloses a method for diagnosing a subject as having an inflammatory disease or disorder when particular types of secretory antibody-coated bacteria are determined to be present in the biological sample derived from the subject with increased relative abundance (paragraph [0071]). As pointed out above, Flavell discloses that the inflammatory disease or disorder can be non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH) (paragraph [0011]). See also paragraph [0068]. The secretory antibody-coated bacteria can be Actinomyces (paragraph [0071]). Also, in some embodiments, the relative proportion of particular constituent bacterial phyla, classes, orders, families, genera, and species present in the microbiota of a subject is determined and compared with that of a comparator normal microbiota (paragraph [0070]). Also, the biological sample can be a fecal sample (paragraph [0077]). Flavell discloses the diagnostic methods in conjunction with their therapeutic methods for treating an inflammatory disease or disorder associated with an altered microbiota including secretory antibody-coated microbes, wherein the inflammatory disease or disorder treatable by their methods include NAFLD and NASH (paragraph [0108]). Flavell meets limitations of the method of diagnosing NAFLD in a subject in need thereof of instant claim 10 because the determination of increased relative abundance of Actinomyces in the microbiota for diagnosing NASH or NAFLD of Flavell is directed to measuring a level of Actinomyces in the microbiota of the subject, detecting a level of Actinomyces higher than a control level (the comparator normal microbiota), and determining the presence of NASH or NAFLD based on the level of Actinomyces being higher than the control level (the increased relative abundance of Actinomyces). Before the effective filing date of the claimed invention, it would have been obvious to the person of ordinary skill in the art to substitute the technique of diagnosing NAFLD or NASH in the subject with the technique disclosed by Flavell when performing the invention of Smith, specifically by measuring a level of Actinomyces in the gut microbiota of the subject (directed to measuring a level of Actinomyces in the gastrointestinal system of the subject), detecting a level of Actinomyces higher than a control level (the comparator normal gut microbiota), and determining the presence of NAFLD or NASH based on the level of Actinomyces being higher than the control level (increased relative abundance of Actinomyces). It would have been an obvious matter of simple substitution of a technique for diagnosing NAFLD or NASH for another. It would have been obvious to measure the level of Actinomyces in the gut microbiota of the subject because Smith recognizes the alteration of gut microbiota as being linked to NAFLD and NASH, which indicates that there would have been a reasonable expectation of success of diagnosing NAFLD and NASH in the subject. Therefore, instant claims 10, 11 (obvious that diagnosis of NAFLD includes diagnosing any severity of NAFLD, including NAFL), and 12 are rendered obvious. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Smith (as evidenced by Finegold) in view of Flavell, as evidenced by Steininger, as applied to claims 1, 4-6, and 10-12 above, and further in view of Lea (US 2020/0368292). As discussed above, Smith (as evidenced by Finegold) in view Flavell (as evidenced by Steininger) renders obvious claims 1, 4-6, and 10-12. The references differ from claim 13 in that they do not expressly disclose that the level of Actinomyces in the gastrointestinal system is measured from a biological sample selected from saliva, small intestinal aspirate, or stomach aspirate. Lea discloses that a GI tract sample of use in the analysis of microbiota profiles may include any fluid or solid taken from the lumen or surface of the GI tract, or any of the tissues that form the organs of the GI tract (paragraph [0019]). These include stomach and intestinal contents (paragraph [0019]). Also, the sample may be obtained mechanically from the GI tract, such as by aspirate (paragraph [0019]). Before the effective filing date of the claimed invention, it would have been obvious to use an aspirate of the gastrointestinal tract, specifically a stomach aspirate or a small intestinal aspirate, from the subject for measuring the level of Actinomyces in the gastrointestinal system when performing the method rendered obvious by Smith in view of Flavell (as evidenced by Finegold and Steininger). One of ordinary skill in the art would have been motivated to do this because the GI microbiota (gut microbiota) can be analyzed from aspirates taken from the GI tract, including from its organs, as indicated in Lea. Therefore, instant claim 13 is rendered obvious. Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSAN EMILY FERNANDEZ whose telephone number is (571)272-3444. The examiner can normally be reached 10:30am - 7pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. Sef /SUSAN E. FERNANDEZ/Examiner, Art Unit 1651
Read full office action

Prosecution Timeline

Oct 09, 2024
Application Filed
Sep 24, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
52%
Grant Probability
99%
With Interview (+60.8%)
3y 8m (~1y 9m remaining)
Median Time to Grant
Low
PTA Risk
Based on 562 resolved cases by this examiner. Grant probability derived from career allowance rate.

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