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 May 18, 2026. Any objections and/or rejections made in previous actions, and not repeated below are hereby withdrawn.
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 (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 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 1-2, 6, 10-16 and 18-25 are rejected under 35 U.S.C. 103 as being unpatentable over Samuel et al. (WO 2019/008102 A1) in view of Rochat et al. (WO 2018/206434 A1).
With respect to Claim 1, Samuel et al. teaches a composition for fortifying human milk comprising one or more of a sialylated, a fucosylated, and an N-acetylated oligosaccharide, [Pg. 1, Par. 7-8] and teaches a composition may comprise 3’-sialyllactose, Lacto-N-Neotetraose, and 2-Fucosyllactose. [Table 1] 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.
Where Samuel et al. teaches the use of one or more of the recited HMOs, one of ordinary skill in the art would have found it obvious to develop a composition comprising 3’-sialyllactose, Lacto-N-neotetraose, and 2-Fucosyllactose where these compounds are known to be beneficial to infants. Therefore, Samuel et al. reads on the limitations of the HMOs in the recitation of claim 1.
The preamble of the instant claim recites a method “for enhancing bone development and/or bone strength in a human infant or child fed formula or growing milk, the method comprising administering a composition comprising”. The phrase “for enhancing bone development and/or bone strength” is a recitation of an intended use. 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 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”. The instant claim recites the limitation “wherein the administering of the composition enhances bone development and/or bone strength”. Due to the presence of the same components in 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.
Samuel et al. is silent to the use of the composition for human infant or children fed infant formula or growing milk.
Rochat et al. teaches a composition comprising human milk oligosaccharides designed to increase butyrate production, specifically, 2’FL, DFL, LNnT, LNT, 3SL, and 6SL. [Page 3, Par. 4] Additionally, Rochat et al. teaches that the composition can be used to fortify breast milk and infant formula. [Pg. 18, Par. 8]
Samuel et al. and Rochat et al. exist within the same field of endeavor in that they teach compositions comprising human milk oligosaccharides for human infant and child consumption. Where Samuel et al. teaches a composition designed to fortify breast milk, Rochat et al. teaches a composition that can be used to supplement infant formula.
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. in view of Rochat et al. in order to devise a method for enhancing bone development and/or bone strength in a human infant or child fed infant formula, wherein the method comprises administering a composition of human milk oligosaccharides, wherein the oligosaccharides comprise at least one sialylated oligosaccharide, chosen from 3'-sialyllactose (3'-SL) and/or 6'-sialyllactose (6'-SL), at least one N-acetylated oligosaccharide chosen from, lacto-N-tetraose (LNT) and/or lacto-N-neotetraose (LNnT), and at least one fucosylated oligosaccharide, chosen from 2'-fucosyllactose (2'FL) and/or 2',3-difucosyllactose (LFDT), thereby rendering claim 1 obvious.
With respect to Claim 2, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. Additionally, Rochat et al. teaches that the composition may be administered to preterm infants. [Pg. 23, Par. 3] 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. in view of Rochat et al. in order to devise the invention recited in claim 1, wherein the invention is administered to preterm infants.
With respect to Claim 6, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. Additionally, Rochat et al. teaches the use of both 2’-fucosyllactose and difucosyllactose, also known as 2’,3-difucosyllactose. [Pg. 18, Par. 8] 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. in view of Rochat et al. in order to devise the invention recited in claim 1, wherein the fucosylated oligosaccharide is 2'-fucosyllactose (2'FL) and 2',3-difucosyllactose (LFDT), thereby rendering claim 6 obvious.
With respect to Claims 10, 18, 20, and 21, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. 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 instant invention, to have used the teaching of Samuel et al. in view of Rochat et al. 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 11, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. 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.
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”. Due to the presence of the same components in the instant composition and the composition taught by Samuel et al. in view of Rochat 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, 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. in view of Rochat et al. to administer the composition recited in claim 1, wherein the enhancement of the bone growth and/or health would comprise a physiological process from those enumerated in the recitation of claim 11, thereby rendering claim 11 obvious.
With respect to Claims 12 and 13, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. 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.
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”. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Due to the presence of the same components in the instant composition and the composition taught by Samuel et al., both compositions would share the same properties upon administration to a subject. 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. in view of Rochat et al. to administer the composition recited in claim 1, wherein the administering of the composition results in bone mineral density (BMD), bone mineral content (BMC), Bone volume and tissue volume faction (BV/TV), bone ultimate force (Fmax), elastic energy, and decreases cortical porosity (CtPo), thereby rendering claim 12 and 13.
With respect to Claim 14 and 15, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. Rochat et al. teaches that the composition can be used to fortify breast milk and infant formula and [Pg. 18, Par. 8] Rochat et al. teaches that the composition may be administered to preterm infants. [Pg. 23, Par. 3] 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. in view of Rochat et al. in order to devise the invention recited in claim 1, wherein the invention is a preterm infant formula.
With respect to Claims 16 and 19, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. 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. in view of Rochat et al. renders obvious claims 16 and 19.
With respect to Claim 22, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. Additionally, 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.
With respect to Claims 23-25, Samuel et al. in view of Rochat et al. teaches the invention recited in claim 1, as described above. Additionally, Rochat et al. teaches a composition comprising human milk oligosaccharides designed to increase butyrate production, specifically, 2’FL, DFL, LNnT, LNT, 3SL, and 6SL. [Page 3, Par. 4] 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. in view of Rochat et al. in order to devise an invention according to claim 1, wherein the at least one sialylated oligosaccharide consists of 3'-SL and 6'-SL, the at least one N-acetylated oligosaccharide consists of LNT and LNnT, and the at least one fucosylated oligosaccharide consists of 2'FL and LFDT, thereby rendering claims 23-25 obvious.
Response to Arguments
Applicant’s arguments with respect to the rejection of claims 1-2, 6, 10-16, and 18-21 on Pages 6-8 of remarks filed April 17, 2026 have been considered but are moot because the new ground of rejection relies on a new reference applied for any teaching or matter specifically challenged in the argument.
Conclusion
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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