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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/19/2026 has been entered.
Withdrawal of Rejections
The response and amendments filed on 02/19/2026 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minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments.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Briefly, the previous claim rejection under 35 U.S.C 103 for obviousness has been withdrawn necessitated by Applicant’s amendments.
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 Objections
Claim 15 is objected to because of the following informalities: claim 15 recites “The composition of 1”; however, this should read “The composition of claim 1”. Appropriate correction is required. This is an objection, not a rejection, because this appears to be a typographical error.
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 1, 6-8, 10, 14-16, 23, 31-33, 35, 37, and 39-40 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 1 recites “a bacterial strain of the genus Butyricimonas that consists of a 16s rRNA sequence of SEQ ID NO: 846”; however, it is unclear how a bacterial strain can only have the 16s rRNA sequence of SEQ ID NO: 846 since bacteria can contain other rRNA, DNA, proteins, etc. Therefore, it is unclear how this bacterial strain only consists of SEQ ID NO: 846. The examiner suggests amending the claims to “wherein the SEQ ID consists of” to clarify the scope of the claim if this is the intent.
Claim 6 recites “wherein the bacterial strain shares at least 70% DNA-DNA hybridization with the strain Butyricimonas faecihominis P40-F2a”; however, it is unclear how the bacterial strain can share DNA-DNA hybridization with Butyricimonas faecihominis P40-F2a when the claimed strain only consists of SEQ ID NO: 846, which is an rRNA sequence, and does not have DNA.
Claim 7 recites “wherein the bacterial strain comprises a nucleotide sequence having 70% identity to any one of SEQ ID NOs: 1-845”; however, it is unclear if the claimed strain is limited to SEQ ID NO: 846, or not. Independent claim 1 recites that the bacterial strain consists of SEQ ID NO: 846, but dependent claim 7 recites that the bacterial strain comprises any one of SEQ ID NOs: 1-845. Therefore, it is unclear if the claimed bacterial strain is limited to SEQ ID NO: 846, or if the claimed bacterial strain comprises SEQ ID NO: 846 and other nucleotide sequences, such as SEQ ID NOs: 1-845.
Claim 8 recites that the bacterial strain comprises a genome with at least 95% ANI with the genome of Butyricimonas faecihominis P40-F2a” and claim 10 recites that the bacterial strain is Butyricimonas faecihominis P40-F2a; however, it is unclear how the claimed bacterial strain can be Butyricimonas faecihominis P40-F2a since independent claim 1 recites that the bacterial strain only consists of SEQ ID NO: 846 and Butyricimonas faecihominis P40-F2a is a bacterial strain that contains other biological features such as DNA, other rRNA, proteins, etc. Therefore, it is unclear if the claimed strain is limited to SEQ ID NO: 846, or if the claimed bacterial strain comprises a 16s rRNA sequence, wherein the rRNA sequence consists of SEQ ID NO: 846.
Claims 10, 14-16, 23, 31-33, 35, 37, and 39-40 are included in this rejection for depending on independent claim 1 and failing to rectify the noted deficiency.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-8 and 10 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 recites “a bacterial strain of the genus Butyricimonas that consists of a 16s rRNA sequence of SEQ ID NO: 846”, which has been interpreted to mean that the bacterial strain only consists of SEQ ID NO: 846 (see 112(b) rejection above regarding this). However, claims 6-8 and 10 fail to further limit the bacterial strain of claim 1 because claims 6-8 and 10 open up the subject matter (i.e., bacterial strain) of claim 1 instead of further limiting the subject matter of claim 1. More specifically, claim 6 recites that the bacterial strain shares at least 70% DNA-DNA hybridization with Butyricimonas faecihominis P40-F2a; however, independent claim 1 states that the bacterial strain consists of SEQ ID NO: 846. Therefore, this language opens up the claimed invention by claiming that the bacterial strain also comprises DNA in order to share at least 70% DNA-DNA hybridization with Butyricimonas faecihominis P40-F2a. Claim 7 recites that the bacterial strain comprises 70% identity to any one of SEQ ID NOs: 1-845; however, independent claim 1 states that the bacterial strain consists of SEQ ID NO: 846. Therefore, this language opens up the claimed invention by claiming that the bacterial strain also comprises other nucleotide sequences and not just SEQ ID NO: 846. Claims 8 and 10 claim that the bacterial strain is Butyricimonas faecihominis P40-F2a, however, independent claim 1 states that the bacterial strain consists of SEQ ID NO: 846. Therefore, this language opens up the claimed invention by claiming that the bacterial strain is Butyricimonas faecihominis P40-F2a, which comprises other rRNA, DNA, proteins, etc. Therefore, claims 6-8 and 10 fail to limit the subject matter of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112(a), Written Description
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 15 and 16 are rejected under 35 U.S.C. 112(a) 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.
Claim 15 recites “…wherein the composition comprises a therapeutically effective amount of the bacterial strain sufficient to prevent or treat a disorder when administered to a subject in need thereof.” Claim 16 recites “…wherein the disorder is cancer.” Applicant is broadly claiming treatment or prevention of all disorders, and further, all cancers.
With regards to the written description set forth in the instant specification pertaining to treatment or prevention of a disorder, wherein the disorder is cancer (claims 15-16), the instant specification teaches that Butyricimonas faecihominis P40-F2a administration to mice results in a significant reduction in melanoma tumor volume and colon cancer tumor volume (see, e.g., instant specification, Examples 5.1-5.2). Based on these teachings, the instant specification does not set forth a representative number of species for the claimed invention, which is not sufficient for the claimed genus (see, e.g., MPEP 2163(II)(3)(ii)). The instant specification only teaches two cancers (i.e., melanoma and colon cancer) that Butyricimonas faecihominis P40-F2a was able to reduce the tumor volumes for in mice. Therefore, Applicant is deemed to have possession of treating melanoma and colon cancer in mice; however, the Applicant is not in possession of all disorders and all cancers. Furthermore, the instant specification lacks written description and guidance for treating or preventing other disorders or cancers in subjects in need thereof.
Claim Rejections - 35 USC § 112(a), Enablement
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 15-16 are rejected under 35 U.S.C. 112(a) as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
In re Wands (858 F2d, 721, 727, 8 USPQ 2d 1400, 1404 (Fed Cir. 1988)), the issue of
enablement in molecular biology was considered. It was held that the following factors should be
considered to determine whether the claimed invention would require the skilled artisan undue
experimentation:
1) Amount of experimentation necessary;
2) Amount of direction or guidance presented;
3) Presence or absence of working examples;
4) Nature of the invention;
5) State of the prior art;
6) Relative skill of those in the art;
7) Predictability or unpredictability of the art; and
8) Breadth of the claims.
Claim 15 recites:
The composition of 1, wherein the composition comprises a therapeutically effective amount of the bacterial strain sufficient to prevent or treat a disorder when administered to a subject in need thereof.
Claim 16 recites:
The composition of claim 15, wherein the disorder is cancer.
Nature of the invention: The invention is directed towards a method of treating or preventing disorders and cancers by administering the composition of claim 1.
Breadth of the claims: As claimed, the composition is effective at preventing or treating all disorders and all cancers.
Amount of direction or guidance presented: The instant specification recites “Compositions and methods disclosed herein can be used to treat various forms of
inflammatory disorders, gastrointestinal disorders, and/or dysbiosis in a subject” (see, e.g., instant specification, [00114]). Additionally, the instant specification recites “Compositions and methods disclosed herein can also be used to treat cancer in a subject” and “Examples of cancers include solid tumors, soft tissue tumors, hematopoietic tumors and metastatic lesions. Examples of hematopoietic tumors include, leukemia, acute leukemia, acute lymphoblastic leukemia (ALL), B-cell, T-cell or FAB ALL, acute myeloid leukemia (AML), chronic myelocytic leukemia (CML), chronic lymphocytic leukemia (CLL), e.g., transformed CLL, diffuse large B-cell lymphomas (DLBCL), follicular lymphoma, hairy cell leukemia, myelodyplastic syndrome (MDS), a lymphoma, Hodgkin's disease, a malignant lymphoma, non-Hodgkin's lymphoma, Burkitt's lymphoma, multiple myeloma, or Richter's Syndrome (Richter's Transformation). Examples of solid tumors include malignancies, e.g., sarcomas, adenocarcinomas, and carcinomas, of the various organ systems, such as those affecting head and neck (including pharynx), thyroid, lung (small cell or non-small cell lung carcinoma (NSCLC)), breast, lymphoid, gastrointestinal (e.g., oral, esophageal, stomach, liver, pancreas, small intestine, colon and rectum, anal canal), genitals and genitourinary tract (e.g., renal, urothelial, bladder, ovarian, uterine, cervical, endometrial, prostate, testicular), CNS (e.g., neural or glial cells, e.g., neuroblastoma or glioma), or skin (e.g., melanoma). In certain embodiments, the cancer is colorectal cancer (CRC)” (see, e.g., instant specification, [00118]). The instant specification teaches “As used herein, "treat", "treating" and "treatment" mean the treatment of a disease in a subject, e.g., in a human. This includes: (a) inhibiting the disease, i.e., arresting its development; and (b) relieving the disease, i.e., causing regression of the disease state” (see, e.g., instant specification, [00115]). Therefore, the instant specification teaches that Butyricimonas faecihominis P40-F2a can theoretically treat any disorder and any cancer.
Presence or absence of working examples: The instant specification teaches that Butyricimonas faecihominis P40-F2a can decrease production of IL-27, TRAIL, IL-6 IFN-β, IL-12p70, IL-1β, and IL-23 by human monocyte-derived dendritic cells (see, e.g., instant specification, Example 3.2). The instant specification teaches that Butyricimonas faecihominis P40-F2a can decrease production of IFN-γ, IL-1β, IL-6, TRAIL, and TNF by human PBMCs (see, e.g., instant specification, Example 3.3). The instant specification teaches that Butyricimonas faecihominis P40-F2a can decrease production of IL-1β, IL-12p40, and TND by THP-1 M2 macrophages (see, e.g., instant specification, Example 3.4). The instant specification teaches that Butyricimonas faecihominis P40-F2a administration to mice results in a significant reduction in melanoma tumor volume and colon cancer tumor volume (see, e.g., instant specification, Examples 5.1-5.2). The instant specification teaches administering Butyricimonas faecihominis P40-F2a to mice with melanoma and colon cancer (see, e.g., instant specification, Example 5); however, the instant specification does not teach the prevention of melanoma and colon cancer, nor does the instant specification teach the prevention or treatment of other cancers and disorders, in general.
Based on the Applicant’s disclosure, the Applicant would not be enabled for all disorders and all cancers, nor would the Applicant be enabled for prevention of all disorders and all cancers. There is no guidance on treatment of cancers besides colon cancer and melanoma, nor is there guidance of prevention of cancers, or disorders in general, as Applicant only reduced to practice treatment of colon cancer and melanoma by administering Butyricimonas faecihominis P40-F2a.
State of the prior art: Cotterill (What is cancer?; 2014 – newly cited) teaches “Cancer is not a single disease but a wide range of different diseases of which there well over a hundred types. Cancers can be classified into two broad types: haematological (malignancies of the blood) or solid tumours” (see, e.g., Cotterill, “What is Cancer”, pg. 1). Furthermore, Cotterill teaches “The cause of most cancers remains unknown. A minority of cancers are known to be hereditary (inherited)” (see, e.g., Cotterill, “What is Cancer”, pg. 1); however, “most cancers have no obvious hereditary cause”, such as exposure to carcinogens, viruses, radiation, or other factors such as diet and exercise (see, e.g., Cotterill, “What is Cancer”, pg. 1). Cotterill teaches “The incidence and types of cancer varies between and also within different countries. It will depend on demographic (population), environmental and other factors. For example there are differences in cancer incidence between different racial groups, diet and climate may also influence cancer incidence [9]. In particular the age distribution of the population will influence the incidence of different types of cancer. The peak incidence of many adult cancers is after the age of 45 (e.g. lung, breast and prostate cancer). Other cancers such as bone tumours, Hodgkin's disease, and cervical cancer are more common in younger adults. Leukaemia is found in people of all ages and is one of the most common type of cancers in adults aged under 35” (see, e.g., Cotterill, “Adult Cancers”, pg. 2).
Furthermore, Dart (Commentary: Eight Ways to Prevent Cancer: a framework for effective prevention messages for the public; 2012 – newly cited) teaches “up to three quarters of some specific cancers – could be avoided by a combination of healthy lifestyle and regular screening” (see, e.g., Dart, Introduction, pg. 1). Moreover, Dart teaches the ways to prevent cancer include “1. Don’t smoke 2. Maintain a healthy weight 3. Exercise regularly 4. Eat a healthy diet 5. Drink alcohol only in moderation, if at all 6. Protect yourself from the sun 7. Protect yourself from infections 8. Get screening tests regularly” (see, e.g., Dart, Introduction, pg. 2). Therefore, based on the teachings of Dart, prevention of cancer is not centered around taking drugs proactively, but about proactively taking care of health and wellness.
Moreover, Yamamoto (WO 2014/130540; Date of Publication: August 28, 2014 – previously cited) teaches that, in some embodiments, Butyricimonas sp. can be administered for the treatment or prevention of cancer (see, e.g., Yamamoto, abstract, [0012], [0015], [0019], [0022], [00140]), but Yamamoto does not reduce this to practice.
Based on the teachings of Cotterill there are many types of cancers, all with different etiologies, and which affect people of different genders, racial groups, and ages. Moreover, cancer prevention is centered around taking care of one’s health and wellness instead of proactively taking pharmaceutical compositions, as taught by Dart. Additionally, Yamamoto teaches that Butyricimonas sp. can be administered for the treatment or prevention of cancer (see, e.g., Yamamoto, abstract, [0012], [0015], [0019], [0022], [00140]), but Yamamoto does not reduce this to practice; therefore, it is unclear from the teachings of Yamamoto which cancers, if any, Butyricimonas sp. can treat. Therefore, the prior art does not teach administration of Butyricimonas faecihominis for the treatment or prevention of cancers and disorders.
Relative skill of those in the art: Based on the state of the prior art, the relative skill of those in the prior art pertaining to treating or preventing disorders and cancers by administering Butyricimonas faecihominis is low.
Predictability or unpredictability of the art: The level of unpredictability within the art is high, as there are many types of cancers and disorders, and it is unpredictable as to whether Butyricimonas faecihominis can treat or prevent these cancers and/or disorders. Moreover, the prior art of Cotterill teaches “Cancer is not a single disease but a wide range of different diseases of which there well over a hundred types” (see, e.g., Cotterill, “What is Cancer”, pg. 1). Furthermore, Cotterill teaches that the cause of most cancers remains unknown (see, e.g., Cotterill, “What is Cancer”, pg. 1); therefore, it is unpredictable how Butyricimonas faecihominis would treat or prevent all cancers. Further, the specification does not contemplate how disorders, in general, as well as other cancers, besides melanoma and colon cancer, can be treated or prevented through administration of Butyricimonas faecihominis. Therefore, the level of unpredictability within the art is high.
Amount of experimentation necessary: Since there are many types of cancers and disorders, one of ordinary skill in the art would have undue experimentation in order to determine if Butyricimonas faecihominis can treat disorders, in general, as well as cancers, besides colon cancer and melanoma. Moreover, one of ordinary skill in the art would have undue experimentation in order to determine if Butyricimonas faecihominis can prevent cancers and disorders. Therefore, the amount of experimentation is high.
Conclusion
Claims 1, 6-8, 10, 14-16, 23, 31-33, 35, 37, and 39-40 are rejected. However, these claims appear free from the art because the prior art does not teach 100% sequence identity to SEQ ID NO: 846.
No claims 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.
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, Sharmila Landau can be reached at (571) 272-0614. 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.
/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Prosecution Insights