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 .
This Office Action is in response to applicant’s submission dated November 18, 2025. Any objections and/or rejections made in previous actions, and not repeated below are hereby withdrawn.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5-6, 11-16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Samuel et al. (WO 2019008102 A1).
With respect to Claim 1, Samuel et al. teaches a composition for fortifying human milk comprising a sialylated, a fucosylated, and an N-acetylated oligosaccharide, [Pg. 1, Par. 7-8] wherein the sialylated oligosaccharide is 3’-sialyllactose and wherein the N-acetylated oligosaccharide is Lacto-N-Neotetraose. [Example 3] Samuel et al. also teaches that the composition may be used to supplement breast milk for an infant. [Example 3] This reads on the limitations “administering a composition” and “a subject” wherein the composition is administered through the breastmilk and the subject is the infant.
The preamble of the instant claim recites a method “for enhancing bone development and/or bone strength in a subject in need thereof, the method comprising administering a composition comprising”. The phrase “for enhancing bone development and/or bone strength” is a recitation of an intended use. The additional recitation of the “subject in need thereof,” in this case, is not considered to further limit to whom the composition is administered, as there is no limit on who is “in need of “ enhancing bone development and/or bone strength. According to the MPEP 2111.02 II, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”.
Samuel et al. teaches a method of administering a composition comprising a mixture of oligosaccharides as set forth above with regard to claim 1. MPEP 2112.01 II states, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” The instant claim recites the limitation “wherein the administering of the composition enhances bone development and/or bone strength”. Due to the identical nature of the instant composition and the composition taught by Samuel et al., both compositions would share the same properties upon administration to a subject, including the ability of the composition to promote bone growth and health.
Therefore, Samuel et al. teaches a method of administering a composition that anticipates claim 1.
With respect to Claim 2, Samuel et al. teaches the composition as described above for administration to a human infant. [Example 3] Therefore, Samuel et al. anticipates claim 2.
With respect to Claim 5, Samuel et al. teaches the composition as described above wherein the fucosylated oligosaccharide is monofucosyllacto-N-hexaose III. [Example 3] Therefore, Samuel et al. anticipates claim 5.
With respect to Claim 6, Samuel et al. teaches the composition as described above wherein the fucosylated oligosaccharide is monofucosyllacto-N-hexaose III. [Example 3] Samuel et al. also describes a specific embodiment wherein the fucosylated oligosaccharide can be selected from a group consisting of 2’-Fucosyllactose. [Page 5, Par. 5] One of ordinary skill in the art would be able to at once envisage the composition taught by Samuel et al. in Example 3 as comprising 2’-Fucosyllactose in place of, or in addition to, the monofucosyllacto-N-hexaose III.
MPEP 2131.02 III, states “A reference disclosure can anticipate a claim when the reference describes the limitations but ‘does not expressly spell out’ the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Therefore, Samuel et al. anticipates claim 6.
With respect to Claim 11, Samuel et al. teaches a method of administering a composition comprising a mixture of oligosaccharides as set forth above with regard to claim 1. MPEP 2112.01 II states, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”
The instant claim recites the limitation “where enhancement of bone development and/or bone strength comprises at least one physiological processes” wherein the physiological processes are focused on promoting bone growth and bone health. Due to the identical nature of the instant composition and the composition taught by Samuel et al., both compositions would share the same properties upon administration to a subject, including the ability of the composition to promote bone growth and health. Therefore, Samuel et al. anticipates claim 11.
With respect to Claims 12 and 13, Samuel et al. teaches a method of administering a composition comprising a mixture of oligosaccharides as set forth above with regard to claim 1. MPEP 2112.01 II states, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” The instant claims recite “where administering the composition increases bone mineral density (BMD), bone mineral content (BMC), Bone volume and tissue volume faction (BV/TV), bone ultimate force (Fmax) and elastic energy” in claim 12, and “where administering the composition decreases cortical porosity (CtPo)” in claim 13 are recitations of inherent properties of the composition.
Due to the identical nature of the instant composition and the composition taught by Samuel et al., both compositions would share the same properties upon administration to a subject. Therefore, Samuel et al. teaches a method of administering a composition that anticipates claim 12 and 13.
With respect to Claim 14 and 15, The instant specification states that infant formula is defined as food stuff intended for particular nutritional use by infants during the first months of life. [Page 10, Lines 15-16] Samuel et al. teaches a human milk fortifier composition for infants of up to 1 month. [Example 3] Therefore, Samuel et al. anticipates claims 14 and 15.
With respect to Claim 16 and 19, Samuel et al. teaches the composition as described above comprising sialylated, fucosylated, and N-acetylated oligosaccharides. [Example 3] The composition taught by Samuel et al. comprises 6 mg/g 3’-sialyllactose, 10 mg/g fucosyllacto-N-hexaose III, and 4 mg/g lacto-N-neotetraose in a composition with a total of 998 mg/g. [Example 3] The resulting percentages are 0.6% at least one sialylated oligosaccharide, 0.1% at least one fucosylated oligosaccharide, and 0.4% at least one N-acetylated oligosaccharide. Therefore, Samuel et al. anticipates claims 16 and 19.
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.
The factual inquiries 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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 10, 18, and 20-22 is rejected under 35 U.S.C. 103 as being unpatentable over Samuel et al. (WO 2019008102 A1).
With respect to Claim 10, 18, 20, and 21, Samuel et al. teaches the composition as described above comprising sialylated, fucosylated, and N-acetylated oligosaccharides. [Example 3] Additionally, Samuel et al. teaches that the oligosaccharide composition can have a variable range depending on the application of the composition. [Table III] The composition taught by Samuel et al. may comprise 1-11 mg/L 3’-sialyllactose, 7-27 mg/L fucosyllacto-N-hexaose III, and 3-32 mg/L lacto-N-neotetraose, wherein the remaining oligosaccharides comprise between 3.2-73 mg/L. [Table III]
According to the MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed in the prior art’ a prima facie case of obviousness exists.” The ranges provided by the possible combinations overlap with the ranges recited in claims 10, 18, 20, and 21. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have administered the composition recited in claim 1 with the ranges of oligosaccharides recited in claims 10, 18, 20, and 21.
With respect to Claim 22, Samuel et al. teaches the composition as described above comprising sialylated, fucosylated, and N-acetylated oligosaccharides. [Example 3] The composition taught by Samuel et al. comprises 6 mg/g 3’-sialyllactose, 10 mg/g fucosyllacto-N-hexaose III, and 4 mg/g lacto-N-neotetraose in a composition with a total of 998 mg/g. [Example 3] The resulting percentages are 0.6% at least one sialylated oligosaccharide, 0.1% at least one fucosylated oligosaccharide, and 0.4% at least one N-acetylated oligosaccharide.
The range of sialyated oligosaccharide lies within the range recited in claim 22, but the fucosylated and N-acetylated oligosaccharides is only close to the ranges recited in claim 22. According to MPEP 2144.05 II, “[W]here 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.” It would have been obvious to one of ordinary skill in the art to adjust the concentration of the fucosylated and N-acetylated oligosaccharides in order to produce the most nutritious composition.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Samuel et al. to administer a composition with the ranges of oligosaccharides recited in claim 22, thereby rendering claim 22 obvious.
Response to Arguments
Applicant's arguments filed November 18, 2025 have been fully considered but they are not persuasive.
Applicant asserts on Page 7, Lines 18-19, that, “Samuel fails to disclose a method wherein administering the composition enhances bone development and/or bone strength”, and continues on Lines 25-27, “Samuel is silent as to bone development and/or bone strength, let alone enhancing bone development and/or bone strength by administration of the recited composition”.
According to MPEP 2112.01 II states, “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” The composition taught by Samuel et al. teaches all the chemical components recited in the instant invention. Additionally, MPEP 2145 II states, “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.”
Applicant’s assertion that Samuel et al. is silent to the property of bone development and/or bone strength is found to be unpersuasive due to the chemical composition taught by Samuel et al. anticipating the composition of the instant invention. The two compositions will inherently possess the same properties, including those of bone growth and/or development.
Applicant asserts on Page 8, Lines 23-24, that “Samuel merely discloses a concentration range for a set of HMOs with respect to the volume of human milk fortifier”, and continues on Page 9, Lines 1-2, that “Samuel does not disclose the relative amounts of HMOs within the human milk fortifier with respect to a mixture of the HMOs”.
Though Samuel et al. does not explicitly disclose the amounts of and HMO with respect to all HMOs, a percentage of each HMO with respect to the total amount of all HMOs would still exist in a composition comprising HMOs. Additionally, those percentages taught in Samuel et al. overlap with percentages recited in claim 10. Therefore, applicant’s assertion is found to be unpersuasive.
For the reasons stated above, applicant’s assertions have found to be unpersuasive and the rejections of claims 1-2, 5-6, 10-16, and 18-22 are upheld.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH CULLEN MERCHLINSKY whose telephone number is (571)272-2260. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791