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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/23/2026 has been entered.
Withdrawal of Rejections
The response and amendments filed on 04/23/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous claim rejections under 35 U.S.C. 103 for obviousness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102, Anticipation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maltzahn (U.S. Patent No. 10,064,900; Date of Publication: September 4, 2018 – previously cited).
Von Maltzahn’s general disclosure relates to administering fecal material to the gastrointestinal tract of a subject in order to treat or prevent dysbiosis in a mammalian subject (see, e.g., Von Maltzahn, abstract). Moreover, Von Maltzahn discloses that the composition comprising the fecal material can “i) treat a gastrointestinal dysbiosis, and/or ii) engraft at least one type of bacteria present in the therapeutic composition but not present in a mammalian subject prior to treatment; and/or iii) augment at least one type of bacteria not present in the therapeutic composition in a mammalian subject to whom the therapeutic composition is administered” (see, e.g., Von Maltzahn, “Summary of the Invention”, pg. 28, lines 46-52). Furthermore, Von Maltzahn discloses that that pulmonary hypertension is a representative disease that is associated with dysbiosis and is suitable for treatment with compositions comprising fecal bacteria (see, e.g., Von Maltzahn, Table 3).
Regarding claim 28 pertaining to improving pulmonary hypertension, Von Maltzahn teaches orally administering to a mammalian subject an effect amount of a therapeutic agent comprising a purified population of spore-forming bacteria from fecal material (see, e.g., Van Maltzahn, col 2, lines 22-26). Furthermore, Von Maltzahn teaches administering bacteria derived from fecal material to treat or prevent dysbiosis in a subject, wherein the subject can have pulmonary hypertension due to the gut dysbiosis (see, e.g., Von Maltzahn, Table 3). Van Maltzahn teaches “populating the gastrointestinal tract of a human subject comprising the step of administering to the human subject a therapeutic composition comprising a purified population of spore-forming bacteria, under conditions such that a microbial population present in the gastrointestinal tract and/or a microbial population outside the gastrointestinal tract is modulated” (see, e.g., Van Maltzahn, col 3, lines 19-25). Moreover, Van Maltzahn teaches engrafting “at least one type of bacteria present in the therapeutic composition but not present in a mammalian subject prior to treatment” (see, e.g., Von Maltzahn, “Summary of the Invention”, pg. 28, lines 46-52). Furthermore, Von Maltzahn teaches that the bacterial composition comprises Bifidobacterium adolescentis (see, e.g., Von Maltzahn, pg. 34, col. 14, line 56), Faecalibacterium prausnitzii (see, e.g., Von Maltzahn, pg. 34, col. 14, lines 61-62), and Roseburia intestinalis (see, e.g., Von Maltzahn, pg. 34, col. 14, lines 65-66). Since Von Maltzahn teaches administration of bacteria not present in a mammalian subject prior to treatment, one of ordinary skill in the art would readily understand that Bifidobacterium adolescentis, Faecalibacterium prausnitzii, and Roseburia intestinalis are decreased in the patients compared to healthy patients, and that administration of these bacteria will increase these bacteria within the gut of these patients.
Claim Rejections - 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Von Maltzahn (U.S. Patent No. 10,064,900; Date of Publication: September 4, 2018 – previously cited) in view of Choi (Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Prospectives; 2016 – newly cited).
Von Maltzahn’s general disclosure is discussed above.
However, Von Maltzahn does not teach: wherein the substance is feces of healthy subjects (claim 23).
Choi’s general disclosure relates to a review of the efficacy and safety of fecal microbiota transplantation (FMT) for treating a variety of diseases, as well as methodology and donor selection for FMT (see, e.g., Choi, abstract). Choi discloses that specific changes in the composition of the gut microbiota, termed dysbiosis, has been associated with gastrointestinal diseases, metabolic diseases, autoimmune diseases, allergic disorders, and neuropsychiatric disorders (see, e.g., Choi, Introduction, pg. 257). Furthermore, Choi discloses
Regarding claim 23 pertaining to administering feces from healthy subjects, Choi teaches administration of healthy feces to a human donor via “the lower GI route, including colonoscopy, flexible sigmoidoscopy, rectal tube, or retention enema and/ or via the upper GI route such as nasogastric/nasointestinal tubes or gastroduodenoscopy” (see, e.g., Choi, “FMT Procedures”, pg. 263). Furthermore, Choi teaches that FMT can be administered to treat diseases “other than GI disorders in which the gut microbiota is disturbed” (see, e.g., Choi, “Non-GI disorders”, pg. 260), such as “Parkinson’s disease, fibromyalgia, chronic fatigue syndrome, myoclonus dystonia, multiple sclerosis, obesity, insulin resistance, metabolic syndrome, and child hood regressive autism (Table 1)” (see, e.g., Choi, “Non-GI disorders”, pg. 260).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat dysbiosis in a human subject, wherein the subject can have pulmonary hypertension due to the gut dysbiosis, as taught by Von Maltzahn, wherein the human subject is administered FMT therapy to treat the dysbiosis, as taught by Choi. One would have been motivated to do so because Choi teaches that FMT therapy can be administered to treat gut dysbiosis that is “not only with many gastrointestinal (GI) diseases but also with metabolic diseases, autoimmune diseases, allergic disorders, and neuropsychiatric disorders.2 Restoring a healthy microbial community is therefore a promising therapeutic strategy for diseases related with gut dysbiosis.3” (see, e.g., Choi, Introduction, pg. 257). Moreover, Von Maltzahn teaches administration of bacteria derived from healthy patient’s stool samples in order to treat gut dysbiosis, and wherein the patient can have pulmonary hypertension due to the gut dysbiosis (see, e.g., Von Maltzahn, col 2, lines 22-26 & Table 3). Therefore, based on the teachings of Von Maltzahn and Choi, it would have been obvious to administer feces from healthy patients to treat pulmonary hypertension because the bacteria within the healthy patient’s stool sample can be used to treat pulmonary hypertension due to the gut dysbiosis. One would have expected success because Von Maltzahn and Choi both teach administration of fecal components to treat non-GI related health issues due to gut dysbiosis.
Examiner’s Response to Arguments
Regarding Applicant’s arguments pertaining to Callejo not teaching a human patient with pulmonary hypertension (remarks, pages 3-6), as previously stated, the previous 35 U.S.C. 103 rejection has been withdrawn. Callejo was not relied upon on the above presented rejection; therefore, Applicant’s arguments are moot.
Regarding Applicant’s arguments pertaining to Van Maltzahn (remarks, page 6), this argument is not persuasive because Van Maltzahn teaches treatment of a human subject with bacteria derived from the feces of health subjects (see, e.g., Van Maltzahn, col 3, lines 19-25), and Van Maltzahn teaches that the subject can have pulmonary hypertension due to the gut dysbiosis (see, e.g., Von Maltzahn, Table 3). Therefore, Van Maltzahn teaches that pulmonary hypertension is associated with gut dysbiosis.
Conclusion
Claims 23 and 28 are rejected.
No claims are allowed.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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