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 .
Withdrawal of Rejections
The response and amendments filed on 11/28/2025 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minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments.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Briefly, the previous 35 U.S.C. 112(b) rejections for indefiniteness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below. The previous 35 U.S.C. 101 rejections have been withdrawn necessitated by Applicant’s amendments. The previous 35 U.S.C. 102 rejections for anticipation have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.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.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 112(b), Indefiniteness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16 and 17 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites “GvHD”; however, abbreviations must be spelled out completely upon first use for clearing defining the scope since acronyms may stand for multiple terms. The instant specification does not define what GvHD is; however, for the purposes of applying prior art, the Examiner has interpreted GvHD to be Graft vs. Host Disease.
Claim 17 recites “0.1 gram-1 gram of a liquid faecal composition”; however, it is unclear how a liquid composition can be measured in grams. For the purposes of applying prior art, The Examiner has interpreted this to mean that 0.1 gram-1 gram of a faecal composition is mixed with an aqueous solution in order to produce the liquid faecal composition.
New Grounds of Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 103, Obviousness
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, 4-7, 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over Jones (US 2018/0289750; Date of Publication: October 11, 2018 – previously cited) in view of Kakihana (US 2018/0185421; Date of Publication: July 5, 2018 – newly cited).
Jones’ general disclosure relates to “Microbiota restoration therapy (MRT) compositions (e.g., oral MRT compositions) and methods for manufacturing MRT compositions” (see, e.g., Jones, abstract). Furthermore, Jones discloses “An example method for manufacturing an MRT composition may include collecting a stool sample, purifying the stool sample to form a purified sample, stabilizing the purified sample to form a stabilized sample, converting the stabilized sample to a solid, adding one or more additives and/or excipients to the solid to form a treatment composition, and encapsulating the treatment composition” (see, e.g., Jones, abstract). Moreover, Jones discloses the administration of the oral MRT compositions in order to treat disorders and/or conditions of the digestive tract (see, e.g., Jones, [0003]).
Regarding claim 1 pertaining to the faecal composition capsule, Jones teaches a MRT composition comprising a faecal composition that is encapsulated for oral administration, wherein the MRT composition can be used for the treatment of Clostridium difficile infections, as well as treatment of chronic disorders associated with the presence of abnormal enteric microflora (see, e.g., Jones, abstract, [0084]). Furthermore, Jones teaches that the composition comprises a diluent (see, e.g., Jones, [0013]), and one or more non-pathogenic microorganisms (see, e.g., Jones, abstract, [0078], [0080], [0184]). Moreover, one of ordinary skill in the art would readily understand that a faecal composition that is screened for pathogenic microorganisms would still comprise one or more non-pathogenic microorganisms. Furthermore, Jones teaches that the diluent comprises 2.3% of a cryoprotectant (see, e.g., Jones, [0034]).
Regarding claims 2 and 11-15 pertaining to the diluent, Jones teaches that the diluent comprises 2.3% of a cryoprotectant (see, e.g., Jones, [0034]). The 2.3% cryoprotectant is approaching the claimed 2% (see, e.g., MPEP 2144.05(I)).
Regarding claims 4 and 18 pertaining to the cryoprotectant, Jones teaches that glycerol may be used as a cryoprotectant (see, e.g., Jones, [0097]).
Regarding claim 5 pertaining to the capsule being frozen, Jones teaches that the MRT composition may be a frozen preparation (see, e.g., Jones, [0134], [0138], [0159]).
Regarding claims 6 and 17 pertaining to the faecal composition, Jones teaches that the MRT composition comprises 1 gram of human stool (see, e.g., Jones, [0097]).
Regarding claim 7 pertaining to the coating, Jones teaches that the MRT composition can be encapsulated in one or more capsules (i.e., coatings) (see, e.g., Jones, [0020]). Moreover, Jones teaches that the composition may be encapsulated in an enteric coating and a pan coating (see, e.g., Jones, [0119]).
Regarding claims 9-10 and 16 pertaining to treatment of a disease, Jones teaches “introducing a fecal sample of a healthy donor, or a donor having one or more desired characteristics, into a gastrointestinal tract of a patient to repopulate a healthy or desirable gut microbiota. In certain examples, prior to introduction of the fecal sample, the patient's intestinal flora can be disrupted using antibiotics, such that the healthy or desirable gut microbiota, once introduced into the patient, can easily populate the gastrointestinal tract” (see, e.g., Jones, [0081]). Moreover, Jones teaches “The present disclosure is directed to compositions, methods of manufacture and methods of treatment utilizing microbiota restoration therapy (MRT) for the treatment of Clostridium difficile infections (CDI)” (see, e.g., Jones, [0083]). Additionally, Jones teaches “Some of the medical conditions that may be desirably impacted by treatment with MRT compositions may include cardiovascular and/or peripheral vascular disease, allergies, obesity, hypoglycemia, constipation, celiac sprue (e.g., celiac disease), gastrointestinal cancer (e.g. gastrointestinal cancer is at least one of stomach cancer, esophageal cancer, colon cancer gallbladder cancer, liver cancer, pancreatic cancer, colorectal cancer, anal cancer, and gastrointestinal stromal tumors), melanoma, non-squamous cell lung cancer, squamous cell lung cancer, renal cell carcinoma, head and neck tumors, bladder cancer, Hodgkin lymphoma, non-Hodgkin lymphoma, gastric cancer, colorectal cancer, multiple myeloma, esophageal cancer, breast cancer, glioblastoma, mediastinal B-cell lymphoma, other hematologic malignancies, testicular cancer, pancreatic cancer, lymphoma, cervical cancer, ovarian cancer, basal cell carcinoma, neuroblastoma, leukemia, sarcoma, other cancers, myoclonus dystonia, sacrolileitis, spondyloarthropatliy, spondylarthritis, proximal myotonic myopathy; an autoimmune disease nephritis syndrome, autism, travelers' diarrhea, small intestinal bacterial overgrowth, chronic pancreatitis, a pancreatic insufficiency, chronic fatigue syndrome, benign myalgic encephalomyelitis, chronic fatigue immune dysfunction syndrome, Parkinson's Disease (PD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), degenerative neurological diseases, Grand mal seizures or petitmal seizures, Steinert's disease, chronic infectious mononucleosis, epidemic myalgic encephalomyelitis, idiopathic thrombocytopenic purpura (ITP), an acute or chronic allergic reaction obesity, anorexia, irritable bowel syndrome (IBS or spastic colon) Crohn's disease, irritable bowel disease (IBD), colitis, ulcerative colitis or Crohn's colitis, chronic infectious mononucleosis, epidemic myalgic encephalomyelitis, acute or chronic urticarial, lupus, rheumatoid arthritis (RA) or juvenile idiopathic arthritis (JIA), pre-diabetic syndrome, fibromyalgia (FM), Type I or Type II diabetes, acute or chronic insomnia, migraines, and attention deficit/hyperactivity disorder (ADHD)” (see, e.g., Jones, [0083]). Furthermore, Jones teaches preparing an MRT composition for oral administration (see, e.g., Jones, [0090]).
However, Jones does not teach: wherein the faecal composition present in the capsule is a liquid faecal composition (claims 1 and 17).
Kakihana’s general disclosure relates to a composition comprising a fecal microbiota for treatment of graft-versus-host diseases (see, e.g., Kakihana, abstract). Moreover, Kakihana discloses “enterobacteria and metabolites thereof are widely known to play important roles in suppression of inflammation and immunoregulation in a gastrointestinal tract, they are recently suggested of their potential in fecal microbiota transplantation (FMT)” (see, e.g., Kakihana, [0003]). Furthermore, Kakihana discloses a capsule formulation comprising a fecal microbiota composition or a process material thereof for administration to a patients with graft-versus-host disease (see, e.g., Kakihana, [0013]-[0019]).
Regarding claims 1 and 17 pertaining to the capsule containing a liquid faecal composition, Kakihana teaches a capsule formulation comprising a fecal microbiota composition or a process material thereof for administration to a patients with graft-versus-host disease (see, e.g., Kakihana, [0013]-[0019]), wherein the composition of the present invention may take any form of powder, solid or liquid, and further, these powder, solid or liquid form can be made into a capsule formulation (see, e.g., Kakihana, [0050]). Moreover, Kakihana teaches “A capsule formulation is advantageous in that complications such as bleeding caused by insertion of a tube, a large intestine fiberscope or the like can be avoided, and burden placed on the patient upon the transplantation can be reduced” (see, e.g., Kakihana, [0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Jones’ faecal composition, wherein the composition is formulated into a capsule in a liquid form, as taught by Kakihana. One would have been motivated to do so because Kakihana taches “A capsule formulation is advantageous in that complications such as bleeding caused by insertion of a tube, a large intestine fiberscope or the like can be avoided, and burden placed on the patient upon the transplantation can be reduced” (see, e.g., Kakihana, [0050]). Moreover, Jones teaches that the faecal composition that is encapsulated for oral administration, wherein the MRT composition can be used for the treatment of Clostridium difficile infections, as well as treatment of chronic disorders associated with the presence of abnormal enteric microflora (see, e.g., Jones, abstract, [0084]). Additionally, Jones teaches that the capsule can have an enteric coating in order to provide protection in the stomach and have the capsule disintegrate in the small and large intestine (see, e.g., Jones, [0119]). Therefore, based on the teachings of Jones and Kakihana, it would have been obvious to produce a liquid faecal composition contained within a capsule. One would have expected success because Jones and Kakihana both teach administration of faecal compositions in capsules in order to treat diseases.
Examiner’s Response to Arguments
Applicant's arguments filed 11/28/2025 have been fully considered but they are not persuasive.
Regarding Applicant’s argument regarding Jones not teaching the newly inserted limitation in claim 1 stating “wherein the faecal composition present in the capsule is a liquid faecal composition” (remarks, pages 9-10), this argument is not persuasive because, as stated above, all previous 102 rejections in view of Jones were withdrawn, and Kakihana was added to teach the newly inserted limitation in claim 1. Therefore, Kakihana was used to teach “wherein the faecal composition present in the capsule is a liquid faecal composition” because Kakihana teaches a capsule formulation comprising a fecal microbiota composition or a process material thereof for administration to a patients with graft-versus-host disease (see, e.g., Kakihana, [0013]-[0019]), wherein the composition of the present invention may take any form of powder, solid or liquid, and further, these powder, solid or liquid form can be made into a capsule formulation (see, e.g., Kakihana, [0050]). Therefore, Applicant’s arguments are moot.
Regarding Applicant’s argument regarding claim 5 not being taught by Jones (remarks, page 10), this argument is not persuasive because Jones teaches “an illustrative method 300 for preparing a previously purified stool sample (Drug Substance B) for MRT as an oral dosage. Drug Substance B may be a fecal microbiota frozen preparation” (see, e.g., Jones, [0138]). Furthermore, Jones teaches “For example, Drug Substance B may have been processed in a manner similar to steps 200 through 212 described above, with the addition of a cryoprotectant at step 202. After the centrifugation process outlined at step 212, the purified intermediate (e.g. now Drug Substance B) may be refrigerated, frozen, or used for treatment” (see, e.g., Jones, [0138]). Moreover, Jones teaches freeze-dying the composition in the capsule (see, e.g., Jones, [0090]), and one of ordinary skill in the art would recognize that freeze-drying inherently comprises freezing the product (see, e.g., Art of Record, Garrote).
Regarding Applicant’s argument pertaining to Jones teaching a stool composition, which is different than the claimed faecal composition (remarks, page 10), this argument is not persuasive because Applicant is relying on the definition of “stool product” for their argument, which is different than the claimed “faecal composition”. In the instant specification, “the faecal composition comprises a stool fraction and a diluent, wherein the stool fraction comprises one or more non-pathogenic microorganisms and the diluent comprises a cryoprotectant resulting in a final concentration of cryoprotectant in the faecal composition below 8% (v/v) cryoprotectant” (see, e.g., instant specification, pg. 4, lines 1-5). Jones teaches a MRT composition comprising a faecal composition that is encapsulated for oral administration, wherein the MRT composition can be used for the treatment of Clostridium difficile infections, as well as treatment of chronic disorders associated with the presence of abnormal enteric microflora (see, e.g., Jones, abstract, [0084]). Furthermore, Jones teaches that the composition comprises a diluent (see, e.g., Jones, [0013]), and one or more non-pathogenic microorganisms (see, e.g., Jones, abstract, [0078], [0080], [0184]). Moreover, one of ordinary skill in the art would readily understand that a faecal composition that is screened for pathogenic microorganisms would still comprise one or more non-pathogenic microorganisms. Furthermore, Jones teaches that the diluent comprises 2.3% of a cryoprotectant (see, e.g., Jones, [0034]). Therefore, based on the teachings of Jones, Jones teaches the instantly claimed “faecal composition”, as claimed, which comprises a stool fraction and a diluent, as recited in the instant specification.
Art of Record
Garrote P. Preservation of bacterial and micro-organisms by freeze-drying. Barnalab Liofilizados. Published February 10, 2023. https://www.barnalab.com/en/blog/freeze-drying-of-bacteria-and-micro-organisms/
Conclusion
Claims 1-2, 4-7, and 9-18 are rejected.
No claims are allowed.
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.
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