DETAILED ACTION
Status of Application
Claims 1-18, filed 09/18/2023, are pending in this application. Claims 1-18 are currently under consideration.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application is a continuation-in-part of U.S. Patent Application No. 17/560,192, filed December 22, 2021 and now abandoned, which is a continuation of U.S. Patent Application No. 16/941,385, filed July 28, 2020 and now issued as U.S. Patent No. 11,285,105.
Specification
The specification is objected to because of the following informalities:
The use of the trademarks/trade names has been noted in this application (Para. 0026, 0028, 0066-0067, 0069-0070). Although the use of trademarks/trade names is permissible in patent applications, the proprietary nature of the trademarks/trade names should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks. The use of language such as “the product X (a descriptive name) commonly known as Y (trademark)” is not permissible since such language does not bring out the fact that the latter is a trademark. Language such as “the product X (a descriptive name) sold under the trademark Y” is permissible. MPEP §608.01(v). Further, it is noted that the trademarks/trade names are used to identify a source of goods, and not the goods themselves. The formula or characteristics of the product may change from time to time and yet it may continue to be sold under the same trademark/trade name. Thus, a trademark/trade name does not identify or describe the goods associated with the trademark/trade name. Appropriate correction is required.
The data provided in the specification are unclear, given that the data are shown with and without units of measurements (Para. 0033-0041, 0044-0046). Appropriate correction is required.
Information Disclosure Statement
The information disclosure statements, filed 08/25/2025 and 09/17/2025, are acknowledged and have been considered. Please see the attached initialed PTO-1449.
Foreign language references listed in the information disclosure statement(s), for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 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 pre-AIA the applicant regards as the invention.
Claim 1 discloses a method for improving gastrointestinal absorption function by administering to a patient a solution comprising claimed compounds that is not reasonably clear. In the present case, it is noted that said claim does not set forth any steps involved in the method/process, and it is unclear what method/process applicant is intending to encompass. To this point, it is noted that a claim is indefinite where it merely recites an administering/use without any active, positive steps delimiting how this administering/use is actually practiced. This limitation was interpreted as best understood as “orally administering”. Clarification is required.
Claim 16 recites the limitation “the one or more oligosaccharides comprise 2'- fucosyllactose, 3'-sialyllactose, or a combination thereof” that is not reasonably clear. Does this limitation imply/disclose oligosaccharides as a mixture of recited compounds (i.e., comprising)? Clarification is required.
Claims 2-15, 17 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al., US 2014/0335065 (hereinafter referred to as Davis), in view of Chow et al., US 2016/0339046 (cited in IDS; hereinafter referred to as Chow), and Elster et al., US 2018/0104279 (cited in IDS; hereinafter referred to as Elster).
Davis teaches methods for promoting healing of the gastrointestinal tract, e.g., injuries caused by various therapies such as antibiotic therapy, radiation therapy, chemotherapy, surgery or by having various diseases or disorders such as enteric infection, inflammatory bowel diseases, colitis, bowel obstruction, and chronic stress (Claims 1-2, 6, 11, 15; Title; Abstract; Para. 0002, 0005 0110 as applied to claims 1-6). Davis teaches that said method comprises orally administering to a patient in need thereof a ready-to-feed liquid (Title; Abstract; Para. 0002, 0005-0009, 0016, 0038, 0041, 0042, 0055-0056, 0107, 0112 as applied to claims 1, 18) comprising: (i) 0.01-20 mg/ml of such human milk oligosaccharide as 3'-sialyllactose, 6'-sialyllactose, 2'-fucosyllactose, lacto-N-tetraose, lacto-N-neo-tetraose, monofucosyllacto-N-hexaose, lacto-N-fucopentaose I; lacto-N-fucopentaose II and/or a combination thereof (Claims 3-4, 7-8, 12-13; Para. 0020, 0052, 0053 as applied to claims 1, 15-16); and (ii) magnesium, sodium, potassium, calcium, phosphorus (Para. 0097; Examples 1-76 as applied to claims 1, 11-13).
Davis does not specifically teach concentrations of magnesium, sodium, potassium, calcium, phosphorus to be used in the claimed method (Claims 1, 11-13).
Chow teaches oral aqueous compositions for promoting faster recovery from diarrheal illness, reducing intestinal spasms due to diarrhea, reducing the duration of diarrhea, and promoting faster re-colonization of the gastrointestinal tract by beneficial flora following antibiotic treatment (Title; Para. 0010). Chow teaches that said oral compositions may include: (i) 10-5000 mg/l (i.e., 0.001-0.5 w/v %) of human milk oligosaccharide such as 2′-fucosyllactose, 3′-sialyllactose, 6′-sialyllactose, lacto-N-neotetraose, lacto-N-tetraose, lacto-N-fucopentaose I, monofucosyllacto-N-hexaose (Claim 1; Para. 0006, 0008, 0015, 0028-0036 as applied to claims 1-6, 15, 18); in combination with (ii) magnesium (Claim 15; Para. 0046 as applied to claim 1), sodium phosphate (Para. 0041-0042), potassium phosphate (Para. 0048), calcium phosphate (Para. 0049). Chow teaches that said oral compositions may include such electrolytes as 10-100 mEq/l (i.e., about 230-2300 mg/l) of sodium (Claim 1; Para. 0006, 0041-0042); 5-100 mEq/l (i.e., about 196-3900 mg/l) of potassium (Para. 0009, 0048); 0.25 -30 mEq/l (i.e., about 5-600 mg/l) of calcium (Para. 0049 as applied to claims 11-13). Chow also teaches that said oral compositions optionally may include proteins, lipids, and other additives (Claim 9; Para. 0050-0055 as applied to claims 9-10, 14).
Elster teaches oral compositions (Para. 0009) that can be used for control/minimize the effect of chemotherapy and improve the gut microbiota of the subject in need thereof (Para. 0007, 0010 as applied to claims 1, 3). To this point, Elster teaches the oral compositions that may include (i) 0.4-3.8 wt% of human milk oligosaccharide (Claim 1; Para. 0011); (ii) 30-130 mg/l of magnesium; 00-600 mg/l of sodium; 600-1200 mg/l of potassium; 150-600 mg/l of phosphorus; and 400-1500 mg/l of calcium (Para. 0072). Elster also teaches that said oral compositions may include 1.5-2.5 wt% of protein (Para. 0011); and optionally may include such lipids as vitamins A, D, E and K, and/or other additives (Para. 0079 as applied to claims 9-10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use and control concentrations of electrolytes (i.e., magnesium, sodium, potassium, calcium, phosphorus) as taught by Chow and Elster preparing compositions to be used in the method as taught by Davis, because it is prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a new composition to be used for the very same purpose. MPEP 2144.06. In the present instance, the cited prior art teaches liquid compositions comprising human milk oligosaccharides to be used for controlling/improving gastrointestinal functions. Further, with regards to the concentrations as instantly claimed, it is noted that differences in experimental parameters, such as concentration of compounds in a solution/formulation, will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components in amounts closed or overlapping with that as instantly claimed. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results and/or desired effects, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
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 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 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10 of U.S. Patent No. 11,285,105.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the prior patent also claims: A method for improving gastrointestinal absorption deficiency in a patient in need therefor by orally administering to the patient an aqueous solution comprising 0.5-20 g/L of one or more oligosaccharides selected from the group consisting of 2′-fucosyllactose, 3′-sialyllactose, 6′-sialyllactose, lacto-N-tetraose, monofucosyllacto-N-hexaose, lacto-N-fucopentaose and lacto-N-neotetraose; 150-800 mg/L of magnesium; and water, and wherein said aqueous solution does not include more than about 1 g/L of lipids. In the present case, the instant claims are merely broader than prior patent claims that include additional limitations and therefore are more specific.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615