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 Application
Receipt of the Response and Amendment after Non-Final Office Action filed 05/04/2026 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 16, 17, 22, and 23
Withdrawn claims: None
Previously canceled claims: 1-15, and 18-21
Newly canceled claims: None
Amended claims: None
New claims: None
Claims currently under consideration: 16, 17, 22, and 23
Currently rejected claims: 16, 17, 22, and 23
Allowed claims: None
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 16, 17, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Schroven et al. (U.S. 2015/0183814 A1) in view of Di Leo et al. (U.S. 2011/0027230 A1).
Regarding claim 16, Schroven et al. discloses a nutritional composition comprising a spray-dried powder ([0037], [0040]) comprising a mixture of structurally distinct human milk oligosaccharides, the powder as comprising at least 85 wt% HMOs ([0025], [0031], [0038], where the powder is produced from HMOs, water, and solvents, and where substantially all of the water and solvents are removed), comprising 2’-FL, 3-FL, LNT, LNnT, LNFPI, 3’-SL, and 6’-SL ([0025], [0032], [0034]) and a monosaccharide that is L-fucose ([0033]), and wherein the spray-dried powder is free of genetically engineered microorganisms and free of nucleic acid molecules derived from genetically engineered microorganisms ([0011], [0047], where no genetically engineered microorganisms are involved in the provision of the HMOs) and the spray-dried powder contains ≤ 7 wt% water ([0038], “a spray-dried powder of the HMO or HMO precursor or blend is obtained with substantially all…of its water content removed”). Schroven et al. also discloses the nutritional composition as being an infant formula ([0040]) that is configured to provide nutrition to a subject ([0040]).
As for concentrations of components, the claim requires the HMO concentrations as being relative to the mixture of HMOs, rather than the overall spray-dried powder or nutritional composition. Schroven et al. discloses a mixture of HMOs in the following amounts: 3.38 g 2’-FL; 0.87 g 3-FL; 1.20 g LNT; 0.35 g LNnT, 0.27 g 3’-SL, and 0.72 g 6’-SL ([0065]). The total amount of HMOs is thus 6.79 g. The amount of each HMO relative to the total amount of HMOs is: 49.8% 2’-FL; 12.8% 3-FL; 17.7% LNT; 5.15% LNnT; 3.98% 3’-SL; and 10.60% 6’-SL. Such disclosed relative concentrations anticipate the claimed concentration ranges of 30-55 wt% 2’-FL; 10-15 wt% 3-FL; 0-5 wt% LNnT; and 2-4 wt% 3’-SL. The absence of LNFPI in the mixture anticipates the claimed range of 0-20 wt.% LNFPI.
Schroven et al. does not specifically disclose (i) LNT, 6’-SL, or fucose as being at the claimed concentrations or that all the HMOs are produced by microbial fermentation, (ii) the nutritional composition as containing tyndalized probiotic bacteria, or (iii) the tyndalized bacteria/nutritional composition as being for stimulating the immune system of a subject.
However, the disclosure of Schroven et al. that the HMOs may be added individually or in a blend ([0025], [0032], [0034]) effectively renders a range of concentrations of 0-100% obvious for any individual HMO relative to the total HMO concentration. As such, the claimed concentrations of 20-30 wt% LNT and 4-6 wt% 6’-SL are considered obvious. MPEP 2144.05 II A also states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” There is no evidence that the claimed HMO concentrations are critical, which further supports the conclusion that the claimed concentrations are properly deemed obvious. Further still, since the claimed concentrations are directed only to the “mixture of structurally distinct human milk oligosaccharides” yet the claim overall is directed to nutritional composition comprising a powder comprising multiple ingredients, there is no requirement in the claim precluding the addition of other HMOs that would not be considered to be a part of the “mixture”, thus limiting any criticality of any of the claimed HMO concentrations. Such a conclusion is further supported by the lack of any required amount of the mixture in the powder.
As for the fucose concentration, Schroven et al. discloses that it is an optional ingredient ([0025], [0033]), which constitutes an implicit disclosure that the concentration of the fucose may range from 0 wt% to some concentration above 0 wt%. As such, the claimed concentration range of 0-6 wt% L-fucose is considered obvious.
As for the method of production of the HMOs, MPEP 2113 I states: “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” Claim 16 is a product claim, and the requirement that the HMOs are produced by microbial fermentation is a process limitation that does not patentably distinguish the claimed product from that of the prior art.
As for the presence of tyndalized probiotic bacteria, Di Leo et al. discloses tyndalized lactobacilli and/or bifidobacteria as being probiotic material ([0040]).
It would have been obvious to one having ordinary skill in the art to include tyndalized probiotic bacteria in the composition of Schroven et al. First, Schroven et al. discloses the addition of probiotic bacteria, including lactobacteria and bifidobacteria ([0041], [0043]). Absent more specific instruction, a skilled practitioner would be motivated to consult an additional reference, such as Di Leo et al., for detail regarding the probiotic material. Since Di Leo et al. discloses the use of lactobacilli and/or bifidobacteria that has been tyndalized as a probiotic ([0040]), a skilled practitioner would find the addition of tyndalized probiotic bacteria to the composition of Schroven et al. to be obvious. MPEP 2144.06 II.
As for the effect of tyndalized bacteria/nutritional composition, MPEP 2144 IV states: “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Since the claimed inclusion of tyndalized probiotic bacteria was shown to be obvious, including adequate motivation for including the component, the claimed effect of being “for immune system stimulation” need not be specifically disclosed in the prior art. A composition produced according to Schroven et al. and Di Leo et al. will necessarily result in stimulation of the immune system to the same extent the claimed nutritional composition would produce such an effect. The claimed effect of being for stimulating an immune system is thus considered obvious to a skilled practitioner.
As for claim 17, Schroven et al. discloses the nutritional composition as further comprising a probiotic microorganism ([0043]).
As for claim 22, Schroven et al. discloses the powder as comprising at least 90 wt% HMOs ([0025], [0031], [0038], where the powder is produced from HMOs, water, and solvents, and where substantially all of the water and solvents are removed).
As for claim 23, Schroven et al. discloses the powder as containing less than 5% water ([0038]).
Response to Arguments
Claim Rejections - 35 U.S.C. § 103 of claims 16, 17, 22, and 23 over Schroven et al. and Di Leo et al.: Applicant’s arguments have been fully considered but they are not persuasive.
Applicant first argued that paragraph [0040] of Di Leo et al. teaches only the addition of “love and tyndalized” probiotics but not the addition of tyndalized probiotics alone. (Applicant’s Remarks, p. 2, ¶4-¶6) The conclusion was drawn from the subsequent indication in Di Leo et al. that the addition of such probiotics was for the purpose of fermentation/metabolization of fiber, which would not be directly possible with tyndalized bacteria (Applicant’s Remarks, p. 2, ¶5). Applicant concluded that Di Leo et al. does not teach the addition of tyndalized probiotics alone (Applicant’s Remarks, p. 2, ¶7).
However, Examiner disagrees wit the asserted narrow interpretation of paragraph [0040] of Di Leo et al. and maintains that its disclosure is adequate for all that is relied on in the present claim rejection. While Applicant has noted effects disclosed in the paragraph purported to be from the live probiotics, no effects were noted as having been due to the tyndalized bacteria. However, the paragraph nonetheless discloses tyndalized bacteria as functioning as probiotics, which would be improperly disregarded should Applicant’s interpretation of the disclosure be adopted. The tyndalized bacteria must thus be interpreted as imparting some implicit beneficial probiotic attribute, even if the effects highlighted by Applicant would appear to be characteristic only of live bacteria. Accordingly, such implicit beneficial probiotic attributes would provide motivation for incorporating tyndalized bacteria as probiotics into the composition of Schroven et al., which undermines Applicant’s argument.
Applicant then argued that claim 16 does not require live probiotic bacteria (Applicant’s Remarks, p. 2, ¶8 – p. 3, ¶1).
However, claim 16 does not specifically require the exclusion of live bacteria, which thus may be present in the composition. Applicant’s argument is narrower than the claim and is consequently unpersuasive.
Applicant further argued that reliance on Di Leo et al. would necessitate “decoupling” tyndalized probiotics from live probiotics (Applicant’s Remarks, p. 3, ¶5).
However, tyndalization would presumably affect all cells in a treated solution, such that selection of tyndalized probiotics would not require any separation of tyndalized cells from live cells. To the contrary, to the extent a mixture of live and tyndalized cells were desired, a mixture would have to be formed from treated and untreated material. Applicant’s argument that incorporation of tyndalized bacteria as taught in Di Leo et al. would necessitate separation of tyndalized bacteria from a mixture of tyndalized and live bacteria is thus unpersuasive.
Applicant then argued that the beneficial effects disclosed in Di Leo et al. were the result of living probiotics but that neither reference establishing that tyndalized bacteria would stimulate the immune system (Applicant’s Remarks, p. 3, ¶7).
As noted in the claim rejection, though, MPEP 2144 IV states: “The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant.” MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Examiner maintains that since the claimed inclusion of tyndalized probiotic bacteria was shown to be obvious, including adequate motivation for including the component, the claimed effect of being “for immune system stimulation” need not be specifically disclosed in the prior art. A composition produced according to Schroven et al. and Di Leo et al. will necessarily result in stimulation of the immune system to the same extent the claimed nutritional composition would produce such an effect. Applicant’s argument regarding the effects disclosed in Di Leo et al. do not directly address the basis for rejecting the claim limitation and are consequently unpersuasive.
The rejections of claims 16, 17, 22, and 23 have been maintained herein.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Claims 16, 17, 22, and 23 are rejected.
No claims are allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY P MORNHINWEG whose telephone number is (571)270-5272. The examiner can normally be reached 8:30AM-5:00PM.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
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