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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/15/2025 has been entered.
Status of claims
Claims 7-12, 18-29 and 32 as amended on 9/15/2025 are under examination in the instant office action.
Claims 1-6, 13-17, 30 and 31 were canceled by applicants.
Claim Rejections - 35 USC § 112
Indefinite
Claims 7-12, 18-29 and 32 as amended are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 7 and 10 as amended are indefinite with regard to “the individual” who is under administration of a probiotic and additional drugs in the steps e) and f) of the claims 7 and 10 because the preceding steps refer to “the individual prior to acquiring the disease” (steps a, b, c and d). The disease of an individual and/or a patient, if there is a patient with the disease in the step e) of claims 7 and 10, as intended for treating a disease is not identified.
Claims 18 and 32 are also rendered indefinite by reciting “third party with disease” as a candidate for therapeutic fecal transplants as intended for “treating a disease”. No specific definitions are provided in the as-filed specification about a disease of a third party that would be beneficial to an individual in need of treating this disease.
New matter
Claims 18 and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Insertion of the limitation drawn to a donor of probiotic being “a third party with the disease” has no support in the as-filed specification. The insertion of this limitation is a new concept because it neither has literal support in the as-filed specification by way of generic disclosure, nor are there specific examples that would show possession of the concept of the using/administering probiotic derived from “a third party with the disease”.
The specification describes that “third party” donor undergoes processing and screening as family member undergoes (par. 0175-177); and neither family member nor third party donor are recognized as having diseases.
Thus, there is no sufficient support for the limitation drawn to a donor of probiotic being “a third party with the disease”.
Thus, the insertion of limitation drawn to a donor of probiotic being “a third party with the disease” is considered to be the insertion of new matter for the above reasons.
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.
Claims 7-12, 18 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,561,690 (Borody), Choi et al (“Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Perspectives”. Clin Endosc 2016, 49, pages 257-265) and US 11,534,465 (Nieuwdorp et al).
The cited document US 10,561,690 (Borody) teaches a method of treating a disease in an individual, wherein the method comprises steps of acquiring fecal samples from the individual patients and donors, extracting and sequencing DNA from fecal bacteria to establish diversities of operational taxonomic units (OTUs) associated with donors and associated with patients, administering FMT probiotics (fecal microbiota transplant probiotics) to the patients and monitoring the patients (entire document including example 6). The FMT probiotics are derived from healthy donors and comprise Bifidobacterium, Clostridium, Ruminococcus (col. 21, lines 12-20), and Fusobacterium prausnitzii that is previously named Faecalibacterium prausnitzii (col. 21, line 28). The method further comprises administration of antibiotics prior to administering bacterial FMT probiotics (col. 19, lines 62-67) and additional nutritional fluids and mineral salts depending on nutrient deficiency and severity of disease of an individual (col. 9, lines 62-66; col. 10, lines 43-46).
In particular, the cited method of US 10,561,690 (Borody) comprising the steps of:
a) acquiring a fecal sample from the individual patient (example 6; col. 41, lines 60-65);
b, c) processing the fecal sample to extract DNA and to sequence DNA from fecal bacteria of the individual patient (example 6, col. 41, lines 60-65);
d) comparing DNA of bacteria from fecal samples from individual patients and donors to establish diversities of operational taxonomic units (OTUs) associated with donors and associated with patients (example 6; col.42, lines 25-27 and lines 50-54) in order to determine bacteria missing in patients as compared to donors; and
e) administering FMT probiotics that are derived from healthy donors and comprise Bifidobacterium, Clostridium, Ruminococcus (col. 21, lines 12-20), and Fusobacterium prausnitzii that is previously named Faecalibacterium prausnitzii (col. 21, line 28).
Thus, the cited US 10,561,690 (Borody) teaches substantially the same method of “treating a disease in individual in need thereof” as claimed by administering FMT probiotics derived from a selected healthy donor as encompassed by claims 7, 9, 10, 12 and 32.
However, in the method of the cited US 10,561,690 (Borody) the donor of a probiotic fecal transplant is selected as having a healthy diversity of microbiome and a normal predetermined level of bacteria that are reduced in the patients with the health condition.
The cited US 10,561,690 (Borody) is silent about donors being mother or siblings and about the use of autologous fecal sample (when donor is the same individual as a patient before developing a serious condition of disease).
However, the prior art recognizes same/similar concept about selecting donors of fecal transplant from members of patient’s family or using autologous fecal transplant.
For example: the reference by Choi teaches that donors of fecal transplant should be selected from members of patient’s family; that maternal-line first degree relatives have advantage of sharing the greatest number of microbial species in their intestinal microbiota with the recipients; thus, the adaptive immune elects in the mucosal immune system might be more tolerant of the microbiota from the close relatives (paragraph bridging columns 1 and 2 on page 261). The reference by Choi states that patients with recurrent CDI (Clostridium difficile infection) reported that fecal transplant from a relative donor showed higher resolution rate (93%) compared with unrelated donor (84%); for example: see page 261, col. 2, lines 6-9). The reference by Choi also teaches that probiotic fecal transplant is used to treat a variety of disorders including gastrointestinal disorders and non-gastrointestinal disorders including autism, eczema, Parkinson’s disease (page 260, col. 2, last paragraph and table 1).
For example: US 11,534,465 (Nieuwdorp et al) administrating autologous fecal transplant for individuals with autoimmune diseases including diabetes mellitus, celiac disease, rheumatoid arthritis, asthma (col. 2, lines 27-45) prior to acquiring the disease (col. 2, lines 50-57), wherein probiotics of the fecal samples include Bifidobacterium (col.17, lines 12-14), Clostridium, Faecalibacterium, Ruminococcus (col. 12, lines 54-63). US 11,534,465 (Nieuwdorp et al) teaches that autologous fecal transplant stimulates immune system (col. 2, lines 5-14).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to provide fecal probiotic transplant derived from patient’s close relative who has similar variety of intestinal microbial species as the patient or even identical autologous fecal sample when practicing the method of US 10,561,690 (Borody) with a reasonable expectation of success in preventing and treating disease of patients because due to similarity of microbiomes the patients’ immune system would be more tolerant to the fecal transplant from the relative donor as taught by Choi or even more with autologous sample. One of skill in the art would be motivated to select fecal transplant donor as based on similarity of microbiome because fecal transplant from a close relative as a donor with similar microbiome showed higher resolution rate compared with unrelated donor as taught by Choi. One of skill in the art would be motivated to select autologous fecal transplant donor as based on closest similarity because autologous fecal transplant stimulate immune system as taught by US 11,534,465 (Nieuwdorp et al).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 7-12, 18-29 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,561,690 (Borody), Choi et al (“Fecal Microbiota Transplantation: Current Applications, Effectiveness, and Future Perspectives”. Clin Endosc 2016, 49, pages 257-265) and US 11,534,465 (Nieuwdorp et al) as applied to claims 7-12, 18 and 32 above, and further in view of and US 9,855,302 (Gajewski et al) and US 2019/0091242 (Bucci et al)
The cited US 10,561,690 (Borody), Choi et al and US 11,534,465 (Nieuwdorp et al) as above.
The method of the cited US 10,561,690 (Borody) further comprises administration of antimicrobials prior to administering bacterial FMT probiotics (col. 19, lines 62-67) and also administration of additional nutritional fluids and mineral salts depending on nutrient deficiency and severity of disease of an individual (col. 9, lines 62-66; col. 10, lines 43-46).
But US 10,561,690 (Borody) is silent about treating individuals with specific antimicrobial agents that are antibiotic doxycycline and antiparasitic agent ivermectin.
However, US 9,855,302 (Gajewski et al) teaches co-administration of probiotics for modulation of commensal microflora and reestablishment of beneficial commensal microflora in diseased individuals together with antimicrobials (col. 23, lines 48-55) as intended to inhibit level of detrimental microbes (col. 22, lines 37-45), wherein antimicrobials include antibiotic doxycycline (col. 22, lines 54 and 65) and antiparasitic agent ivermectin (col. 23, line 28-33). US 9,855,302 (Gajewski et al) teaches administration of probiotics including Bifidobacterium, Clostridium, Ruminococcus (col. 2, lines 10-29).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify method of US 10,561,690 (Borody) by administering antimicrobials such as antibiotic doxycycline and antiparasitic ivermectin taught/suggested by US 9,855,302 (Gajewski et al) with a reasonable expectation of success in treating a disease with a probiotic composition because prior art, or Borody in particular, teaches treating diseases associated with modulation of commensal microflora by co-administration of probiotics with various antimicrobials and because antibiotic doxycycline and antiparasitic agent ivermectin have been known, taught/suggested by the prior art as suitable antiparasitic agent for inhibiting undesirable detrimental microbes in gut (Gajewski et al).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As stated above the method of the cited US 10,561,690 (Borody) further comprises administration of antimicrobials prior to administering bacterial FMT probiotics (col. 19, lines 62-67) and also administration of additional nutritional fluids and mineral salts depending on nutrient deficiency and severity of disease of an individual (col. 9, lines 62-66; col. 10, lines 43-46).
But it is silent about administering to individuals nutritional supplements including specific nutrients such as vitamin C and zinc.
However, the cited US 2019/0091242 (Bucci et al) teaches a method for providing a dietary supplement as intended to treat nutritional deficiency and to balance metabolism (page 1, section background), wherein the method comprises administering probiotic, vitamin and mineral, wherein vitamin is vitamin C and mineral is zinc (par. 0055, 0068), and wherein the probiotic is Bifidobacterium (0061)
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify method of US 10,561,690 (Borody) by administering or co-administering beneficial nutrients including vitamin C and zinc together with FMT probiotics with a reasonable expectation of success in treating a disease with a probiotic composition because Borody teaches and suggests co-administration of nutritional fluids and mineral salts to individuals receiving FMT depending on severity of individual condition and because prior art teaches co-administration of probiotics, vitamin C and zinc together as a metabolism beneficial nutrient supplements (Bucci).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
As applied to new claims 20-29, drawn to amounts of vitamin C, zinc, doxycycline and ivermectin, it is noted that the recited amounts are not linked to any specific protocol of treatments, doses as intended for specific individuals, proportional ratios in therapeutic compositions. Thus, it is considered to be obvious to one having ordinary skill in the art at the time the claimed invention was filed to optimize protocols and doses of therapeutic compound depending on a specific disease and on a severity of condition of a diseased individual.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 7-12, 18-29 and 32 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims recite a method of treating a generic unspecified disease in a generic individual with a generic unspecified need by administering to the generic individual a composition comprising Bifidobacterium or Faecalibacterium; or a composition comprising Bifidobacterium, Clostridium, Faecalibacterium, Ruminococcus either alone or in combination with vitamin C, zinc and/or antimicrobials.
All claim-recited bacteria are naturally occurring, and they would be found in food products that are obvious substrates for heterotrophic bacteria as the claim-recited bacteria. The claimed bacteria are present in milk and in yogurt products, for example: see Demirci et al (Food Science and Technology, 2022, 154, 112860, pages 1-9). At least vitamin C and zinc are natural compounds. Thus, an edible composition with bacteria and other natural ingredients is administered for ingestion of unlimited population. Therefore, the method as claimed is a mere act of eating and or of basic nutrition which is a natural phenomenon.
The “comparing” step of the claims 7 and 10 are mental steps; and, thus, drawn to abstract ideas.
The additional steps of acquiring samples, processing and sequencing DNA are common, routine and conventional practices.
Therefore, this judicial exception is not integrated into a practical application because claimed elements in combination do not add a meaningful limitation or extra-solution to the claimed method, and the claimed method as a whole is nothing more than an attempt to generally link the claimed invention to a particular technological environment.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 7-12, 18-29 and 32 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 , 21 and 22 of co-pending Application No. 17/406,774.
Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to substantially similar methods for treating diseases by administration a probiotic derived from a donor, wherein the donor is selected as based on the same concept of finding a donor having the same type and amount of bacteria as the individual before acquiring disease. Some of the instant claims are narrower for including administration of zinc, vitamin C, ivermectin and doxycycline. Some the co-pending claims are narrower for reciting list of specific diseases as intended for treatment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed on 9/15/2025 have been considered been fully considered but they are not all found persuasive.
The rejection of claim 12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite, has been withdrawn in view of Applicants’ arguments and definitions that step of administering at least one bacterium means administering 4 bacteria recited in the claim 12 (response pages 8-9).
The rejection of claims under 35 U.S.C. 102 (a) (1) as being anticipated by US 2019/0091242 (Bucci et al) has been withdrawn in view of current claim amendment.
With regard to claim rejection under 35 USC § 103 Applicants argue that the Borody’s concept for selecting a donor of a probiotic for treating disease is based on the use of a large diversity of bacterial microbiome including the use of a multi-donor sample and that Choi only suggests a probability that donor selected from close relatives would provide for best beneficial outcomes.
This line of arguments is not found convincing with respect to the instant claims because instant claims do not point out who is a patient under administration of a probiotic derived from a selected donor, thus, rendering screening steps non relevant to a method of treating a disease. Besides, Borody describes steps of screening and comparing microbiomes DNAs of patients after probiotic treatment and remission, thereby, prior to acquiring a comeback disease or another disease.
With regard to claim rejection under 35 U.S.C. 101 Applicants argue that the claimed step of “comparing the DNA” is not a mental step and it could not be performed in mind due to nanoscopic nature of DNA for visualization. This argument is not found convincing since DNA libraries are compared by software and/or algorithms which qualify as an abstract idea. Further, instant claims are indefinite with regard the individual under administration of a probiotic. The individual under administration of a probiotic is not a patient diagnosed with some certain disease and is not different form a general representative of a healthy population.
No claims are allowed.
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Vera Afremova
October 15, 2025
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653