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 .
Claim Status
The amendment of 07/25/2025 has been entered. Claims 1, 4, and 12-23, are pending (claim set as filed on 07/25/2025). Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
It is noted that claim 1 was amended to change ‘comprising’ to ‘consisting of’, however, Applicant did not include the proper markings. Applicant is reminded that not using proper markings could result in a notice of non-compliant amendment (see MPEP 714 F.).
Claims 1, 4, 12-13, and 21-23 are currently under examination and were examined on their merits.
Withdrawn Objections/Rejections
All prior art rejections under 35 U.S.C. 103 set forth in the previous Office action are withdrawn in light of the amendment filed on 07/25/2025, and new rejections have been presented, as discussed below.
Claim Interpretation
Claim 1 recites the transitional phrase ‘consisting essentially of’. The MPEP states:
“For the purposes of searching for and applying prior art under 35 U.S.C. 102 and 103, absent a clear indication in the specification or claims of what the basic and novel characteristics actually are, "consisting essentially of" will be construed as equivalent to "comprising." See, e.g., PPG, 156 F.3d at 1355, 48 USPQ2d at 1355 ("PPG could have defined the scope of the phrase ‘consisting essentially of’ for purposes of its patent by making clear in its specification what it regarded as constituting a material change in the basic and novel characteristics of the invention.").” (See MPEP 2111.03)
The Applicant does not point out in the Specification how the transitional phrase ‘consisting essentially of’ relates to the claimed invention, and does not explain what would be considered a significant material change in the characteristics of the claimed invention. Absent any indication within the instant Disclosure of what the Applicant means by 'consisting essentially of’, the Examiner interprets the phrase ‘consisting essentially of’ as ‘comprising’ for the purpose of this examination.
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.
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 factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4, and 12 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Borody et al. (US 2017/0348360 A1, published on 12/07/2017), in view of Morgan et al. ("Dysfunction of the intestinal microbiome in inflammatory bowel disease and treatment", published on 09/26/2012, Genome Biology, Vol. 13, Article number: R79, pages 1-18).
Borody et al.’s general disclosure relates to “compositions and methods for treating various disorders or conditions that are associated with a dysfunctional intestinal microbiota.”; see entire document, including abstract).
Regarding claim 1, please note that the transitional phrase “consisting essentially of” recited in claim 1 is interpreted as ‘comprising’, as discussed above under Claim Interpretation.
Pertaining to a method for treatment of inflammatory bowel disease (IBD), Borodoy et al. teaches a method for treatment of inflammatory bowel disease (IBD) ("compositions and methods that can treat or cure gastrointestinal (GI) disorders such as Inflammatory Bowel Disease (IBD),"; see abstract) consisting of administering to an individual in need of treatment a composition comprising Odoribacter and/or Alistipes bacteria, and fiber ("a method for treating a disorder (e.g., ulcerative colitis or Crohn's disease) in a subject in need thereof, where the method comprises administering to the subject a pharmaceutically active dose of a therapeutic composition comprising live non-pathogenic fecal bacteria"; "a fecal microbiota preparation comprises one or more ... live fecal microorganisms selected from the group consisting of ... Alistipes,"; "In one aspect, a fecal microbiota preparation comprises one or more ... live fecal microorganisms selected from the group consisting of ... Odoribacter splanchnicus,", “Suitable physiologically acceptable adjuvants may be necessary in order to keep the active ingredients suspended. Adjuvants can include and be chosen from among the thickeners, such as carboxymethylcellulose,…and the alginates”; paragraph [0093], [0117], [0146]).
Regarding claim 4, pertaining to the bacteria, Borody et al. teaches wherein the administered Odoribacter bacteria is Odoribacter splanchnicus (“method comprises administering to the subject a pharmaceutically active dose of a therapeutic composition comprising live non-pathogenic fecal bacteria”, "In one aspect, a fecal microbiota preparation comprises one or more ... live fecal microorganisms selected from the group consisting of ... Odoribacter splanchnicus,"; paragraphs [0093], [0117]).
Regarding claim 12, pertaining to the IBD, Borody et al. teaches wherein the IBD is ulcerative colitis (“the present disclosure provides a method for treating a disorder (e.g., ulcerative colitis or Crohn's disease), in a subject in need thereof, where the method comprises administering to the subject a pharmaceutically active dose of a therapeutic composition comprising live non-pathogenic fecal bacteria”; paragraph [0093]).
Borody et al. does not teach a combination consisting essentially of Odoribacter bacteria and/or Alistipes bacteria (instant claim 1), wherein expressly the Odoribacter bacteria is administered and is Odoribacter splanchnicus (instant claim 4). Absent clear indication in the specification of the scope of “consisting essentially of” limits, the claims will be interpreted according to MPEP 2111.03. However, in the interest of compact prosecution, Morgan et al is also cited.
Morgan et al.’s general disclosure is related to “community-wide microbial processes and pathways that underpin IBD pathogenesis” (see entire document, including abstract).
Regarding claims 1 and 4 pertaining to Odoribacter splanchnicus, Morgan et al. teaches “Odoribacter is reduced both in ICD and in pancolonic UC” (page 4, right column, paragraph 3; note, ulcerative colitis (UC), Crohn’s disease (CD), and ileal CD (ICD)), and further discloses: ”The most severe form of UC is pancolitis, in which UC affects the entire colon; this condition is associated with greatly increased risk of colon cancer [56]. Patients with pancolitis did not harbor a clear specificity in their dysbiosis. However, both these patients and ICD patients had a reduced abundance of the Odoribacter genus … As Odoribacter splanchn[ic]us is a known producer of acetate, propionate, and butyrate [57], decreased Odoribacter may affect host inflammation
via reduced SCFA availability.” (page 5, right column, paragraph 2 - page 6, left column, paragraph 1; note, short-chain fatty acids (SCFAs)).
While Borody et al. does not teach a combination consisting essentially of Odoribacter bacteria and/or Alistipes bacteria (instant claim 1), absent a clear indication of bacteria that “materially affect the basic and novel characteristic(s)" of the claimed invention (MPEP 2111.03), providing a composition comprising Odoribacter bacteria and Alistipes bacteria would have been obvious since both bacteria are suggested to be incorporated into the composition. Moreover, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined Borody et al.’s method with Morgan et al.’s teachings on Odoribacter and Odoribacter splanchnicus, to have created a combination consisting essentially of Odoribacter bacteria, wherein the Odoribacter bacteria is administered and is Odoribacter splanchnicus. One would have been motivated to do so, in order to develop a superior method for treatment of inflammatory bowel disease (IBD), since Odoribacter splanchnicus produces anti-inflammatory SCFA, and Odoribacter is reduced in patients with ulcerative colitis and ileal Crohn’s disease (see Morgan et al., page 5, right column, paragraph 2 - page 6, left column, paragraph 1). A skilled artisan would have reasonably expected success in combining Borody et al.’s and Morgan et al.’s teachings, since both references are directed to inflammatory bowel disease.
Claims 1 and 13 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Borody et al. (US 2017 /0348360 A1, published on 12/07/2017), in view of Morgan et al. ("Dysfunction of the intestinal microbiome in inflammatory bowel disease and treatment", published on 09/26/2012, Genome Biology, Vol. 13, Article number: R79, pages 1-18), and Canadien Agency for Drugs and Technologies in Health (“Clinical Review Report: adalimumab (Humira)”, published in Apr 2016, downloaded from https://www.ncbi.nlm.nih.gov/books/NBK539018/, pages 1-72), hereinafter CADTH.
Modified Borody et al.’s teachings have been set forth above.
Additionally, Borody et al. teaches wherein “a patient is assessed using the Disease Activity Index (DAI) or Mayo score system as described in Schroeder et al.” (paragraph [0112]), and wherein patients selected for treatment have mild-to moderate relapsing UC (“Treatment of Ulcerative Colitis … Patients with an HBI of ~7 are selected for treatment by administering a fecal microbiota composition if at least one or more of the following standards is met: ... mild-to-moderate relapsing UC, defined as a ulcerative colitis disease activity index (UCDAI) score ranging from three to eight”; paragraph [0327]).
Modified Borody et al. does not expressly teach wherein the individual has a Mayo score of from 4-10 (instant claim 13).
CADTH’s general disclosure relates to a “systematic review of the beneficial and harmful effects of adalimumab via SC injection at recommended doses for the treatment of adult patients with moderately to severely active UC” (page iii, paragraph 4).
Regarding claim 13, pertaining to the Mayo score, CADTH teaches wherein mild UC activity is indicated by a score of 3 to 5 points, and moderate disease activity is indicated by score ranges of 6-10 points (“The Mayo score and the partial Mayo score are commonly used disease activity indices in placebo-controlled trials in UC. Both have demonstrated correlation with patient assessment of change in UC activity. Mild, moderate, and severe disease activity are indicated by score ranges of 3 to 5 points, 6 to 10 points, and 11 to 12 points, respectively.”; page 42, paragraph 4).
While modified Borody et al. does not expressly teach wherein the individual has a Mayo score of from 4-10 (instant claim 13), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined modified Borody et al.’s method with CADTH’s teachings on the UC Mayo score on mild and moderate disease activity, to have arrived at a method comprising wherein the individual has a Mayo score of from 4 to 10. One would have been motivated to do so, since the Mayo score is commonly used in the art for determining UC disease activity (see above). A skilled artisan would have reasonably expected success in combining modified Borody et al.’s and CADTH’s teachings since both are directed to ulcerative colitis (see above).
Claims 1 and 21-23 are newly rejected as necessitated by amendment under 35 U.S.C. 103 as being unpatentable over Borody et al. (US 2017/0348360 A1, published on 12/07/2017), in view of Morgan et al. ("Dysfunction of the intestinal microbiome in inflammatory bowel disease and treatment", published on 09/26/2012, Genome Biology, Vol. 13, Article number: R79, pages 1-18), and Singh (“Psyllium as therapeutic and drug delivery agent”, published on 01/21/2007, International Journal of Pharmaceutics, Vol. 334, pages 1–14).
Borody et al.’s and Morgan et al.’s teachings have been set forth above.
Additionally, pertaining to administering, Borody et al. teaches wherein a therapeutic composition can be in form of a capsule (paragraph [0105]), and discloses administering an adjuvant prior to administering, or in co-administration with a therapeutic composition (“In an aspect, a therapeutic composition is combined with other adjuvants such as antacids. … In one aspect, an acid suppressant is administered prior to administering, or in co-administration with, a therapeutic composition”; paragraph [0136]).
Modified Borody et al. does not teach wherein the fiber is psyllium (instant claim 21), wherein the bacteria are Odoribacter splanchnicus and are the only bacteria that are administered to the individual (instant claim 22), wherein the Odoribacter splanchnicus and the psyllium are administered to the individual in a capsule comprising the Odoribacter splanchnicus and a separate capsule comprising the psyllium (instant claim 23).
Singh’s general disclosure relates to “the therapeutic value of psyllium for the treatment of constipation, diarrhea, irritable bowel syndrome, inflammatory bowel disease-ulcerative colitis, colon cancer, diabetes and hypercholesterolemia and exploitation of psyllium for developing drug delivery systems” (see entire document, including abstract).
Regarding claim 21, pertaining to psyllium, Singh discloses: “[A] small number of studies have examined the ability of psyllium to maintain remission in ulcerative colitis (…). Dietary fiber has been proven to be beneficial in maintaining remission in human ulcerative colitis, an effect related with an increased luminal production of short-chain fatty acids (SCFA). Dietary fiber supplementation ameliorated colonic damage in HLA-B27 transgenic rats. This effect was associated with an increased production of SCFA, which can act synergistically in inhibiting the production of pro-inflammatory mediators …Because colonic fermentation of psyllium yields n-butyrate, a significant increase in fecal n-butyrat[e] levels was observed after P. ovata seed administration. Hence, psyllium might be as effective as mesalamine to maintain remission in ulcerative colitis” (page 4, right column, paragraph 2 - page 5, left column, paragraph 1). Singh further teaches that “[t]he efficiency of psyllium in relieving gastrointestinal symptoms in patients with ulcerative colitis in remission was studied in a placebo-controlled trial running for 4 months. Grading of symptoms judged psyllium consistently superior to placebo and associated with a significantly higher rate of improvement (69%) than placebo (24%)” (page 5, left column, paragraph 2).
While modified Borody et al. does not teach wherein the fiber is psyllium (instant claim 21), and wherein the bacteria are Odoribacter splanchnicus and are the only bacteria that are administered to the individual (instant claim 22), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Borody et al.’s method with Singh’s teachings on psyllium, to have created a method consisting of administering to an individual a composition comprising a combination consisting essentially of Odoribacter bacteria, and psyllium, wherein the bacteria are Odoribacter splanchnicus and are the only bacteria that are administered to the individual. One would have been motivated to do so, in order to develop a superior method for treatment of inflammatory bowel disease, since both, Odoribacter splanchnicus and psyllium, increase the presence of anti-inflammatory SCFAs (see Morgan, page 5, right column, paragraph 2 - page 6, left column, paragraph 1, and Singh, page 4, right column, paragraph 2 - page 5, left column, paragraph 1). A skilled artisan would have reasonably expected success in combining modified Borody et al.’s and Singh’s teachings, since both references are directed to the inflammatory bowel disease ulcerative colitis.
While modified Borody et al. does not teach wherein the Odoribacter splanchnicus and the psyllium are administered to the individual in a capsule comprising the Odoribacter splanchnicus and a separate capsule comprising the psyllium (instant claim 23), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to have combined modified Borody et al.’s method with Borody et al.’s teachings on a capsule as a dosage form and administration of adjuvants, to have created a method for treatment wherein the Odoribacter splanchnicus and the psyllium are administered to the individual in a capsule comprising the Odoribacter splanchnicus and a separate capsule comprising the psyllium. One would have been motivated to do so, in order to adjust the individual amounts of Odoribacter splanchnicus and psyllium for obtaining optimal treatment results. Further, a skilled artisan would have reasonably expected success, since Borody et al. teaches treatment of individuals with mild-to-moderate relapsing UC (paragraph [0327]), and providing Odoribacter splanchnicus and psyllium in separate capsules for easier adjusting the microbe and/or psyllium dosage based on the severity of the individual’s condition, would have been in the purview of an artisan.
Response to Arguments
In Applicant’s reply from 07/25/2025, Applicant has traversed all previous rejections of claims 1-13 under 35 U.S.C. 103 (remarks, pages 4-6). As discussed above, all previous rejections under 35 U.S.C. 103 have been withdrawn in light of Applicant’s amendment filed on 07/25/2025, and new rejections have been presented. Cunningham et al. and Lau et al. are no longer relied upon. As such, Applicant's arguments regarding Cunningham et al. and Lau et al. are moot. ln light of Applicant’s amendment, Borody et al. and CADTH are still relied upon, in conjunction with Morgan et al. and Singh. Applicant’s arguments regarding Borody et al. have been fully considered, but they are not persuasive.
In Applicant’s reply, Applicant states that “There is nothing in Borody that would inform which combination of bacteria to select”, and that “[t]here is no evidence in Borody that selecting any one or a combination of any of the bacteria would make a superior product, especially since Borody provides no data obtained using any single type of or any combination of specific bacteria.” (remarks, pages 4-5).
The Examiner responds that a superior bacterial combination consisting essentially of Odoribacter splanchnicus for treating inflammatory bowel disease is obvious over Borody et al. in view of Morgan et al., as discussed above. The Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Borody et al. provides a method for treatment of inflammatory bowel disease comprising administering to an individual in need of treatment a composition comprising Odoribacter splanchnicus, and Morgan et al.’s teachings on Odoribacter and Odoribacter splanchnicus provide motivation to use Odoribacter splanchnicus for treating inflammatory bowel disease.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 SANDRA ZINGARELLI whose telephone number is (703)756-1799. The examiner can normally be reached M-F 9-5.
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.
/SANDRA ZINGARELLI/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653