DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s amendment and response filed on 12/5/2025 have been received and entered into the case. Claims 1-11, 16-17 and 19-20 have been canceled. Claims 12-15, 18 and 21 are pending and have been considered on the merits. All arguments have been fully considered.
Withdrawn Objections
Objections are withdrawn in view of applicant’s amendments.
Withdrawn Rejections
Rejections of Claims 12-15, 18 and 21 under 35 U.S.C. 103 as being unpatentable over Jennewein et al (US 2016/0237104 A1; 8/18/2016. Cited on IDS) in view of Schroven et al (US 2015/0183814 A1; 7/2/2015. Cited on IDS) are withdrawn in view of applicant’s amendments.
Rejections of Claims 12-15, 18 and 21 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 and 10-16 of U.S. Patent No 11,582,994 B2 (referred to as the ‘994 patent) are withdrawn in view of applicant’s amendments.
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.
Claims 12-15, 18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Jennewein et al (US 2016/0237104 A1; 8/18/2016. Cited on IDS) in view of Schroven et al (US 2015/0183814 A1; 7/2/2015. Cited on IDS) and Chichlowski et al (US 2015/0305385 A1l 10/29/2015.).
The instant claims recite a nutritional composition comprising a spray-dried powder, wherein the spray-dried powder comprises at least 95% wt. of lacto-N-tetraose (LNT) or lacto-N-neotetraose (LNnT) which has been produced by microbial fermentation comprising the steps of: a) purifying LNT or LNnT from a fermentation broth which does not involve the use of an organic solvent at the end of the purification scheme; b) providing an aqueous solution of the LNT or LNnT of step a), wherein the aqueous solution contains the LNT or LNnT in an amount of at least 35% (w/v) and up to 60% (w/v); and c) subjecting the solution of step b) to spray-drying, wherein the spray-dried powder contains ≤5% wt. of water, and is free of genetically- engineered microorganisms and nucleic acid molecules derived from genetically-engineered microorganisms, at least one probiotic microorganism, and tyndalized probiotic bacteria.
Jennewein teaches a neutral human milk oligosaccharide (neutral HMO) product obtained in solid form by spray drying (Abstract), wherein the neutral HMO is selected from the group consisting of 2′-fucosyllactose, 3-fucosyllactose, lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and lacto-N-fucopentaose I (para 0064). Example 8 demonstrates a spray dried LNT (para 0149). The neutral HMO is present in an amorphous state (para 0081), having a moisture content of <5% (para 0082). The neutral HMO is used in nutrition (para 0083), as additive in human baby food (para 0086). Jennewein does not teach genetically-engineered microorganisms and nucleic acid molecules derived from genetically-engineered microorganisms, therefore, the neutral HMO product of Jennewein is free of genetically-engineered microorganisms and nucleic acid molecules derived from genetically-engineered microorganisms.
The limitation of “which has been produced by microbial fermentation comprising the steps of: a) …; b) …; and c) …” in claim 12 is regarded as product by process type limitation. The patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. When the prior art discloses a product which reasonably appears to be identical with or slightly different than the claimed product-by-process, rejections under 35 U.S.C 102 and/or 35 U.S.C 103 are proper. (MPEP 2113) In addition, Jennewein does teach spray-dried neutral HMOs from microbial fermentation (para 0074).
Jennewein does not teach the spray-dried powder comprises at least 95% wt. of LNT (claim 12).
However, Jennewein does teach the spray-dried powder comprises 72% LNT (para 0149).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of LNT as a matter of routine experimentation. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to optimize the concentration of LNT with a reasonable expectation for successfully obtaining an HMO product.
Jennewein does not teach the product further comprises at least one probiotic microorganism, tyndalized probiotic bacteria (claim 12), and at least one sialylated HMO (claims 13 & 15).
However, Jennewein does teach a nutritional formulation comprising a spray-dried amorphous powder of an HMO. Schroven teaches a nutritional formulation comprising a spray-dried amorphous powder of an HMO intended for use with infants (para 0038, 0040, 0044), wherein the HMO is selected from LNT, LNnT, 3′-SL, and 6′-SL (para 0014), and probiotics can be added (para 0041, 0043). In addition, Chichlowski teaches a nutritional formulation comprising HMO and a probiotic (para 0045, 0047), wherein the probiotic may be either non-viable or viable (para 0055), and said non-viable probiotic may have been heat-killed (para 0035).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate at least one probiotic microorganism, tyndalized probiotic bacteria, and at least one sialylated HMO, since Jennewein and Schroven both disclose a nutritional formulation comprising a spray-dried amorphous powder of an HMO, Schroven discloses that at least one probiotic microorganism and at least one sialylated HMO are added to the nutritional formulation, and Chichlowski discloses that probiotic exerts at least one beneficial effect on the health of a host, and non-viable probiotic that have been heat-killed is included in the nutritional formulation. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate at least one probiotic microorganism, tyndalized probiotic bacteria, and at least one sialylated HMO, with a reasonable expectation for successfully obtaining an HMO product.
Jennewein does not teach the HMO product further comprises at least one additional neutral HMO (claims 13-14).
However, Jennewein does teach the neutral HMO is selected from the group consisting of 2′-fucosyllactose, 3-fucosyllactose, lacto-N-tetraose (LNT), lacto-N-neotetraose (LNnT), and lacto-N-fucopentaose I (para 0064).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate at least one additional neutral HMO, since Jennewein discloses more than one neutral HMOs have been obtained in solid form by spray drying to provide nutrition. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate at least one additional neutral HMO with a reasonable expectation for successfully obtaining an HMO product.
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 12-15, 18 and 21 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 16-17 and 21-23 of co-pending Application No. 16/769,897 (referred to as the ‘897 application).
Claims 16-17 and 21-23 of the ‘897 application recite a nutritional composition comprising a spray-dried powder comprising 30-55 wt. % 2'-fucosyllactose (2'-FL), 10-15 wt. % 3'-fucosyllactose (3'-FL), 20-30 wt. % lacto-N-tetraose (LNT), 0-5 wt. % lacto-N-neotetraose (LNnT), 2-4 wt. % 3'-sialyllactose (3'-SL), and 4-6 wt. % 6'-sialyllactose (6'-SL), wherein all HMOs in the composition have been produced by microbial fermentation, wherein the spray-dried powder is free of genetically engineered microorganisms and free of nucleic acid molecules derived from genetically engineered microorganisms, wherein the spray-dried powder contains < 7 % wt. of water, and wherein the nutritional composition further comprises at least one probiotic microorganism and tyndalized probiotic bacteria.
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12-15, 18 and 21 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 12-15, and 17-24 of co-pending Application No. 16/769,964 (referred to as the ‘964 application).
Claims 12-15, and 17-24 of the ‘964 application recite a nutritional composition comprising a spray-dried powder, wherein the spray-dried powder comprising LNT and/or LNnT which has been produced by microbial fermentation, at least one probiotic microorganism, and tyndalized probiotic bacteria.
The ‘964 application does not recite the claimed concentration of LNT and/or LNnT (claim 12).
However, the ‘964 application does recite the spray-dried powder comprises LNT and LNnT (Claim 14).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to optimize the concentration of LNT and LNnT as a matter of routine experimentation. Generally, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. (MPEP 2144.05 II) Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to optimize the concentration of LNT and LNnT with a reasonable expectation for successfully obtaining a spray-dried powder.
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 12-15, 18 and 21 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 and 10-16 of U.S. Patent No 11,582,994 B2 (referred to as the ‘994 patent) in view of Di Leo et al (US 2011/00027230 A1; 2/3/2011.).
Claims 1-4 and 10-16 of the ‘994 patent recite a nutritional composition comprising a spray-dried powder, wherein the spray-dried powder comprises at least 80%-wt. 3-fucosyllactose which has been produced by microbial fermentation, wherein the nutritional composition further comprises at least one probiotic microorganism. The nutritional composition further comprising at least one additional HMO, wherein said at least one additional HMO is a neutral HMO or a sialylated HMO, wherein the at least one neutral HMO is selected from the group consisting of 2′-fucosyllactose, lacto-N-tetraose, lacto-N-neotetraose and lacto-N-fucopentaose I.
‘994 patent does not teach the product comprises tyndalized probiotic bacteria (claim 12).
Di Leo teaches a composition comprising tyndalized probiotics, wherein said probiotics maintain or balance the intestinal physiology and help metabolize the indigestible and insoluble fibre (para 0040).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate tyndalized probiotic bacteria, since ‘994 patent discloses a nutritional composition, and Di Leo discloses that probiotics, both live and tyndalized, maintain or balance the intestinal physiology and help metabolize the indigestible and insoluble fibre. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference to incorporate tyndalized probiotic bacteria, with a reasonable expectation for successfully obtaining an HMO product.
Response to Arguments
Applicant argues that Jennewein does not describe a spray-dried powder comprising at least 95% wt. of LNT or LNNnT, that Jennewein does not describe a process of fermentative production of the composition, that Jennewein does not describe a production process using an aqueous solution with 35-60% (w/v) LNT or LNnT; that Jennewein does not describe a spray-dried powder that contains <5 % wt of water, that Jennewein does not describe a spray-dried powder that is free of genetically-engineered microorganisms and nucleic acid molecules derived from geneticallyengineered microorganisms, that Jennewein does not describe a nutritional composition comprising a probiotic, and that Jennewein is silent about the purity of the lacto-N-tetraose in the fractions that were concentrated, sterile filtered and spray-dried in Example 8.
These arguments are not found persuasive. Remarks in the previous Office action filed on 6/5/2025 is maintained, and repeated below.
Jennewein does teach the spray-dried powder comprises 72% LNT (para 0149). According to MPEP 2144.05 II, differences in concentration will not support patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. Applicant has failed to provide evidence demonstrating the criticality of the claimed concentration of LNT. In addition, rejected claims are directed to a composition, the patentability of a product does not depend on its method of production. If the claimed product is the same or obvious from a product in the prior art (i.e. the product disclosed in the cited reference), the claim is unpatentable even though the reference product was made by a different process. (MPEP 2113) Furthermore, Jennewein does teach the neutral HMO having a moisture content of <5% (para 0082), and Jennewein does not teach genetically-engineered microorganisms and nucleic acid molecules derived from genetically-engineered microorganisms. Moreover, Schroven is relied upon to demonstrate that a probiotic can be added to a nutritional formulation comprising a spray-dried amorphous powder of an HMO. Finally, Jennewein does teach the purity of the neutral HMO in the purified solution contains the HMO with a purity of ≥80%, preferably of ≥90% (para 0020, 0035).
Applicant argues that Schroven does not overcome all of the deficiencies of Jennewein.
These arguments are not found persuasive because Schroven is relied upon to demonstrate that a probiotic can be added to a nutritional formulation comprising a spray-dried amorphous powder of an HMO. Since Jennewein and Schroven both disclose a nutritional formulation comprising a spray-dried amorphous powder of an HMO, and Schroven discloses that at least one probiotic microorganism is added to the nutritional formulation. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate at least one probiotic microorganism with a reasonable expectation for successfully obtaining an HMO product.
Applicant argues that cited references do not teach tyndalized probiotic bacteria as amended in claim 12. However, these arguments are moot since those rejections are withdrawn in view of applicant’s amendments.
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 extension fee 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759