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 3/3/2026 have been received and entered into the case. Claims 1-15, 17-27 and 29-36 have been canceled, Claims 40-49 have been added. Claims 16, 28 and 37-49 are pending. Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, Claims 43-49 are withdrawn from consideration as being directed to a non-elected invention. Claims 16, 28 and 37-42 are pending and have been considered on the merits, insofar as they read on the elected species of 2’-fucosyllactose (2’FL) and lacto-N-neotetraose (LNnT). All arguments have been fully considered.
Withdrawn Rejections
Rejections of Claims 16, 28 and 37-39 under 35 U.S.C. 103 as being unpatentable over Chow et al (US 2012/0172319 A1; 7/5/2012. Cited on IDS) in view of Newburg et al (US 2012/0294840 A1; 11/22/2012) are withdrawn in view of applicant’s amendments.
Rejections of Claim 30 under 35 U.S.C. 103 as being unpatentable over Chow et al (US 2012/0172319 A1; 7/5/2012. Cited on IDS) in view of Newburg et al (US 2012/0294840 A1; 11/22/2012) and Fox et al (ISRN Gastroenterol. 2012;1-9. Cited on IDS) are withdrawn in view of applicant’s amendments – Claim 30 has been canceled.
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 16, 28, 37-39, and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al (US 2012/0172319 A1; 7/5/2012. Cited on IDS) in view of Newburg et al (US 2012/0294840 A1; 11/22/2012) and Fox et al (ISRN Gastroenterol. 2012;1-9. Cited on IDS).
The instant claims recite a method for treating constipation in an infant or a young child in need thereof, the method comprising administering to the infant or young child a nutritional composition consisting of 2’-fucosyllactose (2’FL) and lacto-N-neotetraose (LNnT), wherein the infant is a child under the age of 12 months, the young child is a child aged between one year and three years, and the infant or young child was born by C-section, and wherein the effects of the administration on treating constipation are observed within the first month of the administration.
Chow teaches a method for improving gastrointestinal function and tolerance in an infant and toddler in need thereof (para 0002, 0007), thereby treating gastrointestinal diseases and/or disorders resulting from a loss of dysfunction of the gut barrier (para 0006, 0030), comprising administering a nutritional composition including at least one human milk oligosaccharide (HMO) alone (para 0006, 0058), wherein the infant is a person 12 months or younger (para 0041) and toddler is a person greater than one year of age up to three years of age (para 0042), the nutritional composition and method may consist of the essential elements of the composition and method (para 0057), an exemplary combination of the nutritional composition consists of 2’-fucosyllactose (2’FL) and lacto-N-neotetraose (LNnT) (para 0073). The 2’FL is included in the nutritional composition in an amount of from about 0.001 mg/mL to about 20 mg/mL (para 0053, 0079), and lacto-N-neotetraose (LNnT) is included in the nutritional composition in an amount of from greater than 0.32 mg/mL to about 10 mg/mL (20 mg/mL:10 mg/mL = 2:1) (para 0053, 0084). The nutritional composition may be formulated to provide a supplemental source of nutrition (para 0060). Said HMO relates to human milk fortifier and term infant formulas (para 0002) for consumption by term infant (para 0049).
Chow does not teach the method is for treating constipation in an infant or a young child in need thereof, wherein the effects of the administration on treating constipation are observed within the first month of the administration (claim 16).
However, Chow does teach the method comprises administering a nutritional composition including 2’FL to an infant, wherein 2’FL improves gut function and minimizes gastrointestinal issues (para 0013). Newburg teaches a nutritional composition including 2’FL in the form of an infant formula (para 0011-0012), wherein 2’FL improves the overall health of the gastrointestinal tract including promoting bacterial growth, decreasing pH, and inducing the production of lactic acid, 2’FL is associated with many health benefits including decreased constipation, and administration of 2’FL results in a decrease in constipation (para 0014, 0041, 0049). The “wherein the effects of the administration on treating constipation are observed within the first month of the administration” clause does not recite any additional active method steps, but simply states a characterization or conclusion of the results of process step positively recited (e.g. analyzing). Therefore, the “wherein” clause is not considered to further limit the method defined by the claim and has not been given weight in construing the claim. Furthermore, Chow does teach the method step of administering to an infant or young child a nutritional composition consisting of 2’-fucosyllactose (2’FL) and lacto-N-neotetraose (LNnT), and Newburg does teach the administration of 2’FL results in a decrease in constipation.
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to treat constipation in an infant or a young child in need thereof by administering 2’FL to the infant or young child, since Chow and Newburg both disclose a nutritional composition comprising 2’FL in the form of an infant formula, Chow discloses administering the nutritional composition comprising 2’FL to an infant where 2’FL improves gut function and minimizes gastrointestinal issues, and Newburg discloses 2’FL is associated with many health benefits including decreased constipation and administration of 2’FL results in a decrease in constipation. 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 treat constipation in an infant or a young child in need thereof by administering 2’FL to the infant or young child with a reasonable expectation of success.
References cited above do not teach the method wherein the infant or young child was born by C-section (claim 16).
However, Chow does teach the method reduces the incidence of necrotizing enterocolitis in an infant (a person 12 months or younger, para 0041) or toddler (a person greater than one year of age up to three years of age, para 0042) in need thereof. Fox teaches that a factor attributes to an increase in the incidence of necrotizing enterocolitis is the increase in the number of premature births by Caesarean section for therapeutic reasons resulting in the delivery of premature babies (p.1 col left – para 2).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer the nutritional composition in the method of Chow to an infant or young child born by C-section, since Fox discloses that an increase in the number of premature births by Caesarean section attributes to an increase in the incidence of necrotizing enterocolitis, and Chow discloses a method of reducing the incidence of necrotizing enterocolitis in an infant or toddler in need thereof comprises a nutritional composition consists of 2’FL and LNnT. 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 administer the nutritional composition of Chow to an infant or young child born by C-section with a reasonable expectation for successfully reducing the incidence of necrotizing enterocolitis in the infant or young child in need thereof.
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Chow et al (US 2012/0172319 A1; 7/5/2012. Cited on IDS) in view of Newburg et al (US 2012/0294840 A1; 11/22/2012) and Fox et al (ISRN Gastroenterol. 2012;1-9. Cited on IDS) as applied to claims 16, 28, 37-39, and 42 above, further in view of Cormack (bpj15_formula_pages_26-31.pdf. 2015;1-4.).
References cited above do not teach the method wherein the nutritional composition is administered to an infant within the first six months of birth (claim 40), and wherein the nutritional composition is administered for one month to six months (claim 41).
However, Chow does teach the method comprises a nutritional composition consists of 2’-fucosyllactose (2’FL) and lacto-N-neotetraose (LNnT) (para 0073), wherein the nutritional composition includes infant formula (para 0002, 0006). Cormack teaches that infant formula is formula intended as a substitute to breast milk for infants from birth to six months old (p.2 col left – last section).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer the nutritional composition in the method of Chow to an infant within the first six months of birth or for one month to six months, since Cormack discloses that infant formula is for infants from birth to six months old. 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 administer the nutritional composition in the method of Chow to an infant within the first six months of birth or for one month to six months with a reasonable expectation of success.
Response to Arguments
Applicant argues that the cited references fail to teach or suggest the recited time to observe the effect of treating constipation. However, these arguments are moot in light of the new rejections above.
Applicant argues that Fox provides no teaching or suggestion that being born by C-section is a factor in developing NEC. Thus, the skilled artisan would not have been motivated to modify the method of Chow for reducing the incidence of necrotizing enterocolitis to administer its nutritional compositions to an infant or young child born by C-section, or have a reasonable expectation of success for doing so.
These arguments are not found persuasive because Fox teaches “The condition was first described by Paltauf in 1888 but the term “necrotising enterocolitis” was used for the first time by Schmid and Quaiser in 1953 [7, 8]. Since then, there has been a tremendous increase in the incidence of NEC. This has been attributed largely to two factors. The first is the increase in the number of premature births by Caesarean section for therapeutic reasons resulting in the delivery of premature babies.” Before the effective filing date of the claimed invention, it was well-known in the art that premature births by Caesarean section is a risk factor for NEC. Hence, a skill in the art would administer the nutritional composition in the method of Chow to an infant or a young child born by Caesarean section, since Chow discloses a method of reducing the incidence of necrotizing enterocolitis in an infant or toddler in need thereof comprises a nutritional composition consists of 2’FL and LNnT.
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
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