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 .
DETAILED ACTION
This office action is in response to Applicant’s Amendment and Response to Restriction/Election Requirement filed on 5/5/2026, wherein claims 88-98 are canceled and claims 79 were amended. No claims were newly added.
Claims 79-87 are pending in the instant application and are examined on the merits herein.
Election/Restrictions
Applicants’ election for the invention of Group I drawn to a method of treating or preventing various conditions by administering a composition comprising an HMO prebiotic, a Bifidobacterium probiotic and a butyrate producing bacterium, encompassing claims 79-87, in the reply filed on 5/5/2026 is acknowledged. However, because Applicant did not indicate whether the election of inventions was to be with or without traverse, the election has been treated as an election without traverse (MPEP § 818.03(a)). Applicants cancelled without prejudice claims 88-98, which encompassed the subject matter of Groups II thru V. In view of the cancellation of claims 88-98, the above restriction requirement is withdrawn.
Priority
The application is a National Stage entry of PCT/US2021/045951 filed on 8/13/2021, which claims priority to provisional applications 63/225170, filed on 7/23/2021 and 63/065991 filed on 8/14/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 2/13/2024, 2/9/2024, 9/8/2025 and 11/3/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609, except where noted. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Claim Rejections - 35 USC § 103
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 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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 79, 80, 82, 85 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over Dutta et al. (US 2019/0262407A1, IDS).
Dutta et al. discloses a method for treating inflammatory bowel disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome, or antibiotic-associated bacterial dysbiosis by administering a composition comprising butyrogenic bacteria, Bifidobacterium spp. and a prebiotic, where the butyrogenic bacteria is selected from Clostridium butyricum, Eubacterium limosum, Eubacterium rectale, Faecalibacterium prausnitzii, Roseburia faecis, and Roseburia intestinalis, further where the prebiotic is selected from among a group of saccharides, including 3'-fucosyllactose, 3'-sialyllactose, 6'-sialyllactose, lacto-N-neotetraose and 2'-fucosyllactose. (Claims 1-10, 17-19)
Dutta does not exemplify, or limit within the claims, that the prebiotic is a human milk oligosaccharide.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select any one, or a combination, of the prebiotics suggested by Dutta, including any one or a combination of the human milk oligosaccharides taught, thereby arriving at the instant invention. Dutta incudes several human milk oligosaccharides among a list of functionally equivalent prebiotics. One of ordinary skill in the art would have a reasonable expectation that any of the prebiotics taught by Dutta would be effective in the method of treatment taught therein.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 81 is rejected under 35 U.S.C. 103 as being unpatentable over Dutta et al. (US 2019/0262407A1, IDS), in view of Schneider et al. (US 9,999,641 B2; 2018, PTO-892), or in the alternative over Kjaerulff et al. (US 11,179,447 B2; 2019, PTO-892), or in the alternative over Nandakumar et al. (US 11,701,394 B2; Feb 2020, PTO-892).
The disclosure of Dutta is referenced as discussed above. Dutta does not teach strains of Faecalibacterium prausnitzii, Roseburia faecis, and Roseburia intestinalis, having the claimed identity percentage to one of SEQ ID 77-167.
Schneider et al. discloses a 16S ribosomal RNA sequence of Roseburia faecis, strain M72/1, SEQ ID No: 92 (Col. 127), which has 100% identity to instant SEQ ID No: 157. (see sequence results summary) Schneider also discloses that the bacterial strains therein, including R. faecis with SEQ ID 92, maybe administered to combat dysbiosis. (Col. 11,Ln. 53; Col. 18)
Kjaerulff et al. discloses a 16S ribosomal RNA sequence of Faecalibacterium prausnitzii, SEQ ID No: 12 (Col. 67), which has 100% identity to instant SEQ ID No: 77. (see sequence results summary) Kjaerulff also discloses that F. prausnitzii, maybe administered to combat IBD. (Col. 10, Ln. 35)
Nandakumar et al. discloses a 16S ribosomal RNA sequence of Roseburia intestinalis, SEQ ID No: 295 (Figure 16AAAAN) which has 100% identity to instant SEQ ID No: 85. (see sequence results summary) Nandakumar also discloses that R. intestinalis, maybe administered to combat IBD. (Col. 2, Ln. 11)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to look to Schneider et al., Kjaerulff et al. or Nandakumar et al., for guidance on specific strains of Faecalibacterium prausnitzii, Roseburia faecis, or Roseburia intestinalis, that would be expected to be effective in the method of Dutta. One would be motivated to look among the analogous art of treating conditions, such as dysbiosis or IBD, for specific strains of Faecalibacterium prausnitzii, Roseburia faecis, or Roseburia intestinalis, because Dutta is silent on such specific strains. One would expect equivalent behavior for any Faecalibacterium prausnitzii, Roseburia faecis, or Roseburia intestinalis strain known to be effective for combating the conditions taught by Dutta, to be effective in the method of Dutta.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claims 83 and 84 are rejected under 35 U.S.C. 103 as being unpatentable over Dutta et al. (US 2019/0262407A1, IDS), in view of Kyle et al. (US 2018/0267037A1, PTO-892).
The disclosure of Dutta is referenced as discussed above. Dutta does not teach the species of Bifidobacterium as being B. longum subspecies infantis.
Kyle et al. discloses that certain bifidobacteria (preferably B. longum and more preferably B. longum subspecies infantis) can internalize and metabolize the complex oligosaccharides that make up about 15% of the energy content of human milk. These oligosaccharides, which are not processed by human gut enzymes, are referred to herein as human milk oligosaccharides (HMOs) and the consumption of the HMOs by these bifidobacteria leave little or no residual energy source available for the growth of other bacterial species in the lower colon of the breast-fed human infant. In the absence of these bifidobacteria species, a number of other species can grow uncontrollably leading to dysbiosis that can result in significant medical consequences. (¶0003)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to look to Kyle, as analogous art, for what species of Bifidobacterium are appropriate in a treatment method, such as that taught by Dutta. Since Dutta discloses treating dysbiosis with Bifidobacterium spp. and Kyle teaches that B. longum subspecies infantis is known to combat dysbiosis, one would be motivated to select B. longum subspecies infantis as a preferred species in the method of Dutta.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
Claim 86 is rejected under 35 U.S.C. 103 as being unpatentable over Dutta et al. (US 2019/0262407A1, IDS), in view of Sprenger et al. (US 2018/0110253A1, PTO-892).
The disclosure of Dutta is referenced as discussed above. Dutta does not teach that the administered composition comprises at least 10 HMOs.
Sprenger discloses that the following HMOs are effective as prebiotics, specifically consumed by Bifidobacterium, lacto-N-tetraose, lacto-N-neotetraose,
3'-sialyllactose, 6'-sialyllactose, 2'-fucosyllactose, 3-fucosullactose, difucosyllactose, lacto-N-fucopentaose I, lacto-N-fucopentaose II, lacto-Nfucopentaose III, lacto-N-fucopentaose V, lacto-Ndifucohexaose I, monofucosyllacto-N-hexaose, Difucosyllacto-N-hexaose I and Difucosyllacto-N-neohexaose II. (¶0044; Claims 6, 14)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that based on the disclosure of Sprenger, that at least 10 HMOs are known in the art to be effective prebiotics for consumption by Bifidobacterium spp. Hence, it would be obvious to modify the method of Dutta by expanding on the effective Bifidobacterium prebiotics, to include those taught by Sprenger, thereby arriving at the instant invention.
Accordingly, the instant claims are prima facie obvious over the teachings of the prior art.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 79-87 of the instant application are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over US 19/259517. Although the conflicting claims are not identical, they are not patentably distinct from each other because: The method of ‘517 is drawn to treating or preventing a disease, disorder, or condition associated with one or more of dysbiosis of the intestinal microbiome, inflammation, infection, allergy, or immune dysfunction in a subject in need thereof, the method comprising administering to the subject (i) a prebiotic mixture comprising one or more human milk oligosaccharides and (ii) at least one probiotic strain of bacterium capable of consuming the one or more human milk oligosaccharides, which is anticipated by the instant claims.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DALE R MILLER whose telephone number is (571) 272-6146. The examiner can normally be reached on M-F 7:00 AM – 3:30 PM 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, Scarlett Goon can be reached on (571) 270-5341. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center and the Private Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from Patent Center or Private PAIR. Status information for unpublished applications is available through Patent Center and Private PAIR to authorized users only. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/DALE R MILLER/ Primary Examiner, Art Unit 1693
Prosecution Insights