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 .
Status of the Claims
Claims 84-103 are pending (claim set as filed on 05/23/2025).
Priority
This application is a CON of 16/084,154 (now abandoned), which is a 371 of PCT/US2017/022209 filed on 03/13/2017, which has a provisional application no.: 62/307,420 filed on 03/11/2016.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 10/16/2024, 05/23/2025, and 07/24/2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Drawings
The drawings filed on 05/23/2025 have been accepted.
Abstract Objection
The abstract of the disclosure is objected to because it does not comply with the proper language and format (see MPEP 608.01(b)). Appropriate correction is required.
Applicant is reminded of the proper language and format for an abstract of the disclosure. The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as “means” and “said” should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns”, “The disclosure defined by this invention”, or “The disclosure describes”, etc.
Claim Rejections - 35 USC §103, Obviousness
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 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 non-obviousness.
Claims 84-103 are rejected under 35 U.S.C. 103 as being unpatentable over Hennet (US 2016/0346303 A1) in view of German (US 2013/0195803 A1 – cited in the IDS filed on 10/16/2024).
Hennet’s general disclosure relates to compositions and methods for the treatment of irritable bowel syndrome (IBS) (see ¶ [0001]). Hennet discloses that treatment of IBS include various forms such as dietary adjustments, medication, and psychological interventions (see ¶ [0004]-[0005]).
Regarding base claim 84’s preamble and claim 99 pertaining to the patient population, Hennet discloses that “the terms ‘irritable bowel syndrome’ and ‘IBS’ preferably mean a group of functional bowel disorders of humans, particularly adults” (see ¶ [0046], [0069]). Hennet further discloses “the causes of IBS are unknown but disruptions of the brain-gut axis, acute gastrointestinal infections, small intestinal bacterial overgrowths, antibiotic usages and dysbiosis are thought to be important risk factors” (see ¶ [0002]-[0003]). Hennet teaches “it has been found that HMSs/HMOs reduce the risk of re-occurrence of IBS in patients, particularly those who are suffering from bacterial overgrowth, dysbiosis or an impaired mucosal barrier” (see ¶ [0040]).
Regarding claims 84(a) and 91 pertaining to the oligosaccharide dose, Hennet teaches the daily treatment product contains either 5 or 10 grams of a combination of 2'-FL, LNnT, LNT, 3-FL, 6'-SL and 3'-SL (see Example 1).
Regarding claims 85-86 pertaining to the diet, Hennet discloses a recent development in IBS treatment has been the FODMPA diet that requires patients to restrict the intake of carbohydrates where adherence to this diet has resulted in symptom improvements; the FODMAP carbohydrates are beneficial fibers, and foods that contain them are common, highly nutritious fruits, vegetables and legumes (see ¶ [0010]). Hennet teaches that the composition can be designed to be the sole source of nutrition or a nutritional supplement; the nutritional composition is also free from, or low in amounts of, FODMAP carbohydrates (see ¶ [0050]).
Regarding claims 89-90 pertaining to the milk oligosaccharides, Hennet teaches “it has been surprisingly found that human milk monosaccharides (HMSs), advantageously sialic acid and/or fucose, and human milk oligosaccharides (HMOs), advantageously 2’-FL, 3-FL, LNT, LNnT, 3’-SL, 6’-SL, DFL, DSLNT and/or LNFP-I, are able to reduce chronic symptoms of irritable bowel syndrome in IBS patients” (see ¶ [0040]-[0044], [0047]).
Regarding claim 102 pertaining to the formulation, Hennet teaches the nutritional compositions “can be in powdered or liquid form. The composition can be designed to be the sole source of nutrition or a nutritional supplement” (see ¶ [0050], [0068]).
Regarding claim 103 pertaining to the antibiotic, Hennet teaches a patient who is undergoing or who has undergone treatment with an antibiotic (see ¶ [0018], [0027], [0036]).
However, Hennet does not teach: the administration of the probiotics Bifidobacterium and Lactobacillus.
German’s general disclosure relates to compositions comprising oligosaccharides and probiotics for administration to treat conditions including: diarrhea, necrotizing enterocolitis, irritable bowel syndrome, allergic reaction, autism, irritable bowel disease, Crohn’s disease, ulcerative colitis, et. al. (see ¶ [0002]-[0005], [0012], [0092]-[0097], [0149]).
Regarding the probiotics, German teaches “Probiotic treatment - often employing cultures of lactobacilli or bifidobacteria delivered in dairy foods - has been linked to beneficial health outcomes in a variety of disease states including reduction in diarrhea, prevention of necrotizing enterocolitis, treatment of irritable bowel syndrome [31], treatment of IBD, and allergic reactions. Given their long history of safe use and GRAS status, probiotic strains selected for the ability to optimally consume BMOs are expected to colonize and persist in the host thus improving their efficacy and imparting benefits to the host. Formulations of BMO and Bifidobacteria are useful therefore addressing many gastrointestinal, and immunological-based health concerns in human, pediatric and other mammalian populations” (see ¶ [0173], [0148]).
Regarding the bifidobacterium, German teaches “the composition further comprises an inoculum of a bacterium (e.g., a probiotic bacterium) or a fungus or yeast (e.g., a probiotic fungus or yeast). In some embodiments, the bacterium is a species of Bifidobacteria. In some embodiments, the bacterium is selected from Bifidobacterium longum subsp. Infantis, B. breve, and B. bifidum” (see ¶ [0087], [0115]). German teaches “the Bifidobacterium used will depend in part on the target consumer. Exemplary bifidobacteria dosages for probiotic formulations include, but are not limited to, 104 to 1012 colony forming units (CFU) per dose. A further advantageous range is 106 to 1010 CFU” (see ¶ [0144]-[0146]).
German teaches “the compositions comprising the oligosaccharides described herein (e.g., in Table 1 or otherwise purified from bovine milk) are administered to an individual, thereby increasing gut colonization and persistence of probiotic bacteria in the individual” (see ¶ [0151]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use or add the probiotics of Bifidobacterium and/or Lactobacillus such as taught by German in the method of Hennet. The ordinary artisan would have been motivated to do so is because German teaches that bifidobacterium and lactobacillus are two routinely employed probiotics in the art as they are generally regarded as safe (GRAS) and have been linked to many beneficial therapeutic effects of the gastrointestinal system. Moreover, the cited prior arts discuss their advantageous combination with particular milk oligosaccharides. The ordinary artisan would have had a reasonable expectation of success is because both of the references are directed to milk oligosaccharides and the microbiota to treat gastrointestinal dysbiosis and conditions including irritable bowel syndrome.
Regarding the claims’ intended results or intended outcomes, a wherein or whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Both of the cited references are directed to increasing the presence of beneficial microbiota including bifidobacteria and they disclose the presence of prebiotics including oligosaccharides facilitate the colonization of the probiotic in the gut. Thus, there is a reasonable desire to administer the appropriate concentration or dosages of prebiotic oligosaccharides and probiotics to increase the number of beneficial probiotics in the gut to restore proper balance for alleviation of dysbiosis and its accompany gastrointestinal disorders.
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 claims at issue 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 reference 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. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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.
Claims 84, 87-88, and 91-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 1, 5-6, and 13-14 (claim set as filed on 07/08/2025) of co-pending Application no. 19/262,777. Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and co-pending ‘777 are directed to methods of treating intestinal dysbiosis comprising administering a probiotic and mammalian milk oligosaccharides.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Notice of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Dikovskiy (US 2011/0200668 A1) relates to medicine, namely to pharmaceutics and the development of compositions of pharmaceutical preparations, containing antibiotics and prebiotics, for correcting the composition of the intestinal microflora during antibiotic therapy (see ¶ [0002]). Dikovskiy discloses that dysbiosis in the natural flora microbiome may lead to opportunistic microorganisms in the intestines where inflammation develops (see ¶ [0003]-[0004]). Dikovskiy teaches a pharmaceutical compositions for preventing and treating intestinal dysbiosis during antibiotic therapy comprising administering prebiotics and probiotics (see ¶ [0016]-[0017], [0077]).
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653
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