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 .
DETAILED ACTION
2. Applicants’ arguments and amendments filed on 6/22/2026 overcomes the rejections of record. However, the new grounds of rejection as set forth below are necessitated by applicants’ amendment and therefore, the following action is Final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 1-4, 7-15 are pending in this office action.
Claims 1-4 are amended.
Claims 7-15 are new.
Claims 1-4, 7-15 have been rejected.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
5. Claims 1,2, 3, 7-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 2 recite “wherein probiotics are excluded from the use”. In applicant’s specification, nowhere it recites “probiotics are excluded” as claimed in claims 1, 2. It is to be noted that in specification, applicants have stated that “In another embodiment the probiotics are non-replicating or inactivated. Probiotic components and metabolites can also be added (at least in PGPUB [0059]). Therefore, if we consider both the paragraphs of the applicants specification, the two embodiments are either it is the components from the inactivated cells or the live cells and both does not exclude probiotic because , by definition, applicants have also stated that “The term “probiotic” means microbial cell preparations or components of microbial cells with a beneficial effect on the health or well-being of the host (in PGPUB [0037]). Therefore, applicants’ specification may exclude live cells in one embodiment, however, applicant’s specification does not exclude ‘probiotic from the use” as claimed in independent claims 1, 2. The reason is, as mentioned above, according to the definition of probiotic in applicants specification, “The term probiotic means microbial cells or components of microbial cells with a beneficial effect on the health” serve as probiotic (in PGPUB [0037]). It is known that inactivated cells also contain cell membranes which provide stimulation of immune response as is evidenced by NPL Adams et al. (at least in Abstract). Therefore, This renders 112 first paragraph rejection of independent claims 1, 2.
Claim Rejections - 35 USC § 102/103
6. 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.
(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.
A rejection on this statutory basis (35 U.S.C. 102(g) as in force on March 15, 2013) is appropriate in an application or patent that is examined under the first to file provisions of the AIA if it also contains or contained at any time (1) a claim to an invention having an effective filing date as defined in 35 U.S.C. 100(i) that is before March 16, 2013 or (2) a specific reference under 35 U.S.C. 120, 121, or 365(c) to any patent or application that contains or contained at any time such a claim.
OR, in the alternative
7. 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:
8. 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.
9. 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 should not be negated by the way the invention was made.
10. The factual inquiries set forth in Graham V. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
C. Resolving the level of ordinary skill in pertinent art.
d. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
11. Claim(s) 1, 2 are rejected under 35 U.S.C. 102 (a) (1) as being
anticipated by Sprenger et al. (US 2019/0290668 A1) OR in the alternative, under
35 U.S.C. 103 as obvious over Sprenger et al. (US 2019/0290668 A1).
12. Regarding claims 1, 2, Sprenger et al. discloses a nutritional composition and a method for oral administration of a nutritional composition for pediatric subject containing HMO comprising 6'SL and can be used alone also ([0141]) as a supplement as unit dose ([0156]). Sprenger et al. also discloses that probiotic may (i.e. optional) be used ([0142]- [0144]) in such a composition. Therefore, it anticipates claims 1, 2.
It is to be noted that even if Sprenger et al. does not specifically mention 6’-SL promotes development of auditory and/or visual function in an infant /or young child, however, the disclosed sialylated oligosaccharide is 6’-SL which is identical to the claimed 6’-SL and therefore will have identical claimed property including the claimed property of “promoting development of auditory and/or visual function in an infant /or young child . Therefore, Sprenger et al. anticipates claims 1, 2.
OR in the alternative
13. Regarding claims 1, 2, Sprenger et al. discloses a nutritional composition and a method for oral administration of a nutritional composition for pediatric subject containing HMO comprising 6'SL and can be used alone also ([0141]) as a supplement as unit dose ([0156]). Sprenger et al. also discloses that probiotic may (i.e. optional) be used ([0142]- [0144]) in such a composition. It is to be noted that even if Sprenger et al. does not specifically mention 6’-SL promotes development of auditory and/or visual function in an infant /or young child, however, the disclosed sialylated oligosaccharide is 6’-SL which is identical to the claimed 6’-SL and therefore will have identical claimed property including the claimed property of “promoting development of auditory and/or visual function in an infant /or young child . Therefore, Sprenger et al. meets the claim limitation of claims 1, 2.
14. Claim(s) 1, 2 are rejected under 35 U.S.C. 102 (a) (1) as being
anticipated by Samuel et al. US 2020/0221749 A1 OR in the alternative, under
35 U.S.C. 103 as obvious over Samuel et al. US 2020/0221749 A1.
15. Regarding claims 1 and 2, Samuel et al. discloses a human milk fortifier composition and a method for oral administration of a nutritional composition for pediatric subject which includes both infants and children containing HMO which comprises 6’SL ([0057]). Samuel et al. also discloses that the human milk fortifier may further comprise one or more ingredient selected from the group consisting of vitamins, minerals, protein, carbohydrates, and probiotics ([0012]). Therefore, it anticipates claims 1, 2.
It is to be noted that even if Samuel et al. does not specifically mention 6’-SL promotes development of auditory and/or visual function in an infant /or young child, however, the disclosed sialylated oligosaccharide is 6’-SL which is identical to the claimed 6’-SL and therefore will have identical claimed property including the claimed property of “promoting development of auditory and/or visual function in an infant /or young child . It is to be noted that probiotic is one of the nutritional components in the Markush group (i. e optional) and it reads on “wherein probiotics are excluded from the method” which anticipates claims 1, 2.
OR in the alternative,
16. Regarding claims 1, 2, Samuel et al. discloses a human milk fortifier composition and a method for oral administration of a nutritional composition for pediatric subject which includes both infants and children containing HMO which comprises 6’SL ([0057]). Samuel et al. also discloses that the human milk fortifier may further comprise one or more ingredient selected from the group consisting of vitamins, minerals, protein, carbohydrates, and probiotics ([0012]). Therefore, probiotic is one of the nutritional components in the Markush group (i. e optional) and it reads on “wherein probiotics are excluded from the method”. Therefore, it meets claims 1 and 2.
17. Claim(s) 4, 13 are rejected under 35 U.S.C. 102 (a) (1) as being
anticipated by Chichlowski et al. US 2015/0305385 A1 OR in the alternative, under
35 U.S.C. 103 as obvious over Chichlowski et al. US 2015/0305385 A1.
18. Regarding claim 4, Chichlowski et al. discloses a composition and a method for oral administration of a nutritional composition for pediatric subject containing HMO comprising 6'SL, which has an improving property of improving the normal mental performance and visual function in a subject (Abstract, [0006], [0014], [0015], [0048], [0071], and claims 1-3 of Chichlowski et al.). Chichlowski et al. also discloses that nutritional composition comprising 6'SL influencing visual function due to development of brain (at least in [0117], Example 2 and at least in Fig 1). Therefore, the disclosed teaching specifically identifies a specific 6'SL component for the visual function also (at least in [0048], [0071], Fig 1 and in [0117]). Therefore, Chichlowski et al. anticipates claim 4.
19. Regarding claim 13, Chichlowski et al. discloses that the composition can include pediatric subjects including 0-12 months and 1-3 years which is the considered age of a child (at least in [0078], [0114]). Therefore, if we consider pediatric age range only, 0-12 months, this range for pediatric age is within the claimed range of 0-24 months which anticipates claim 13.
OR as an obvious variant,
20. Regarding claim 4, Chichlowski et al. discloses a composition and a method for oral administration of a nutritional composition for pediatric subject containing HMO comprising 6'SL, which has an improving property of improving the normal mental performance and visual function in a subject (Abstract, [0006], [0048], [0071], and claims 1-3 of Chichlowski et al.). Chichlowski et al. also discloses that ganglioside -bound SA in the corpus callosum of pigs was increased by 15% over control pigs (at least in [0117], Example 2) which has an impact on visual function (at least on Fig 1). Therefore, the disclosed teaching meets nutritional composition comprising 6'SL influencing visual function due to development of brain (at least in [0117], Example 2 and fig 1). Therefore, the nutritional composition containing HMO comprising 6'SL as disclosed by Chichlowski et al. (Abstract, [0006], [0048], [0071], and claims 1-3 of Chichlowski et al.) would have an obvious effect on promoting auditory and/or visual function in infant and/or children when administered as a nutritional composition which reads on claim 4.
21. Regarding claim 13, Chichlowski et al. discloses that the composition can include pediatric subjects including 0-12 months and 1-3 years which is the considered age of a child (at least in [0078], [0114]). Therefore, if we consider pediatric age range only, 0-12 months, this range for pediatric age is within the claimed range of 0-24 months. If we consider both the disclosed age ranges from 0-12 months pediatric subject and 1-3 yrs for child’s age, then it meets claim 13. It shows prima facie case of obviousness according to MPEP 2144.05. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Claim Rejections - 35 USC § 103
22. 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.
23. 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.
24. 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 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.
25. Claim(s) 3, 7, 8, are rejected under 35 U.S.C. 103 as being unpatentable over Samuel et al. US 2020/0221749 A1.
Claim 2 is relied upon as above.
Regarding claim 3, Samuel et al. discloses that ‘human milk fortifier’ can be tailored to fortify the breast milk of a woman ([0041], [0112]) and woman comprises Human Milk Oligosaccharide (HMO) which includes A-tetra saccharide also (at least in [0123]). Therefore, it would have been obvious that the infant or child who is born to a mother whose milk contains A-tetra saccharide and/or fed breast milk contain A-tetra saccharide which can be fortified with fortifier HMO e.g. 6’-SL with the breast milk of a woman ([0041], [0112]). Therefore, it meets claim limitation of “combinations of 6’-SL and A-tetra saccharide” of claims 3.
26. Regarding claim 7, Samuel et al. also discloses that ‘human milk fortifier’ can be tailored to fortify the breast milk of a woman ([0041], [0112]) and woman comprises Human Milk Oligosaccharide (HMO) which includes A-tetra saccharide also (at least in [0123]). Therefore, it would have been obvious that the infant or child who is born to a mother whose milk contains A-tetra saccharide and/or fed breast milk contains A-tetra saccharide to meet claim 7.
27. Regarding claims 8, it is to be noted that a mother whose milk contains A-tetra saccharide would have been obvious to be genetically predisposed to secrete A-tetra saccharide and therefore, it reads on “wherein the infant or young child is born to a mother who is genetically predisposed to secrete A-tetra saccharide in human breast milk she expresses” as claimed in claim 8.
28. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al. (US 2019/0290668 A1) as applied to claim 2 and as evidenced by Samuel et al. US 2020/0221749 A1 and as evidenced by Vigsnaes et al. (US 2018/0185396 A1).
29. Regarding claim 10, claim 10 depends on claim 2 and therefore, the rejection made for claim 2 is applicable for claim 10 also.
In addition, Sprenger et al. discloses that an oral nutritional composition comprising 3’-SL and 6’-SL ([0128], [0129]) in a ratio between 5:1 to 1:10 ([0130]) and the combined sialylated oligosaccharide can be used 0.05 to 5 gm per 100 gm of composition ([0133]) and can be used alone also ( [0141]) as a supplement as unit dose ([0156]) and daily dose of 0.1 to 2 gm sialylated oligosaccharide ([0191]). The composition can be used as supplement in the infant formula, a starter infant formula, a follow-on formula, a baby food, an infant cereal composition, a fortifier such as a human milk fortifier, or a supplement. In some embodiments, the composition of the invention is an infant formula, or a fortifier or a supplement intended for the first 4 or 6 months of age ([0152], [0166]).
However, the daily dose is optimizable. It is also evidenced by Samuel et al. (e.g. the amount may be tailored to fortify milk [0064]) and Vigsnaes et al. that appropriate dose ranges for such a nutritional component containing composition may be determined by standard method known to those skilled in the art ([0100]).
Therefore, it is within the skill of one of ordinary skill in the art to optimize the daily dose.
Absent showing of unexpected results, the specific daily amount of 6’-SL is not considered to confer patentability to the claims. As the daily requirements are variables which depend on age of the infant, child, body wight, that can be modified, among others, by adjusting the daily amount of 6’-SL, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the daily amount of 6’-SL, in Sprenger et al., to amounts, including that presently claimed, in order to obtain the daily desired effect e.g. daily nutritional requirement (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
30. Claim(s) 11, 12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Chichlowski et al. as applied to claim 4 and further in view of Samuel et al. US 2020/0221749 A1.
31. Regarding claim 11, Chichlowski et al. discloses a composition and a method for oral administration of a nutritional composition for pediatric subject containing HMO comprising 6'SL, "A-tetra saccharide, which has an improving property of improving the normal mental performance and visual function in a subject (Abstract, [0006], [0048], [0071], Fig 1 and [0117] and claims 1-3 of Chichlowski et al.).
Chichlowski et al. is specifically silent about “born to a mother whose milk contains A-tetra saccharide and/or fed breast milk containing “A-tetra saccharide” as claimed in claim 11.
Samuel et al. discloses that ‘human milk fortifier’ which comprises 6’SL ([0057]), can be tailored to fortify the breast milk of a woman ([0041], [0112]) for pediatric subject and woman comprises Human Milk Oligosaccharide (HMO) which includes A-tetra saccharide also (at least in [0123]). Therefore, it would have been obvious that the infant or child who is born to a mother whose milk contains A-tetra saccharide and/or fed breast milk contain A-tetra saccharide which can be fortified with fortifier HMO e.g. 6’-SL with the breast milk of a woman ([0041], [0112]). Therefore, it meets claim limitation of “combinations of 6’-SL and A-tetra saccharide”
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify HMO comprising 6'SL as disclosed of Chichlowski et al. (Abstract, [0006], [0048], [0071], and claims 1-3 of Chichlowski et al.) with the human breast milk containing A-tetra saccharide in order to provide nutritionally enriched human breast milk containing both 6’-SL and A-tetra saccharide to the all-ages of infants including newly born up to the age of a child age also ([0114]) and human milk dependent pediatric individual.
32. Regarding claim 12, Chichlowski et al. is specifically silent about “fortifying human milk from human mother including mother who is genetically predisposed to secrete A-tetra saccharide”.
Samuel et al. also discloses that ‘human milk fortifier’ can be tailored to fortify the breast milk of a woman ([0041], [0112]) and woman comprises Human Milk Oligosaccharid (HMO) which includes A-tetra saccharide also (at least in [0123]). Therefore, it would have been obvious that the infant or child who is born to a mother whose milk contains A-tetra saccharide and/or fed breast milk contains A-tetra saccharide. In addition, it is also to be noted that a mother whose milk contains A-tetra saccharide would have been obvious to be genetically predisposed to secrete A-tetra saccharide and therefore, it reads on “wherein the infant or young child is born to a mother who is genetically predisposed to secrete A-tetra saccharide in human breast milk she expresses” as claimed in claim 12.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify HMO comprising 6'SL as disclosed of Chichlowski et al. (Abstract, [0006], [0048], [0071], and claims 1-3 of Chichlowski et al.) with the human breast milk containing A-tetra saccharide in order to provide nutritionally enriched human breast milk containing both 6’-SL and A-tetra saccharide to all ages of infants including newly born up to the age of a child age also ([0114]) and human milk dependent pediatric individual.
33. Regarding claim 15, it is to be noted that Samuel et al. also discloses that ‘human milk fortifier’ can be tailored to fortify the breast milk of a woman ([0041], [0112]) and woman comprises Human Milk Oligosaccharide (HMO) which includes A-tetra saccharide also (at least in [0123]). Therefore, as breast milk composition is combined with human milk fortifier’ containing 6’SL ([0057]), it meets claim 15.
It is to be noted that the following motivation paragraph is applicable for claims 11, 12 and 15.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify HMO comprising 6'SL as disclosed of Chichlowski et al. (Abstract, [0006], [0048], [0071], and claims 1-3 of Chichlowski et al.) with the human breast milk containing A-tetra saccharide in order to provide nutritionally enriched human breast milk containing both 6’-SL and A-tetra saccharide to the all-ages of infants including newly born up to the age of a child age also ([0114]) and human milk dependent pediatric individual.
34. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Chichlowski et al. US 2015/0305385 A1 as applied to claim 4 and further in view of Sprenger et al. (US 2019/0290668 A1) as applied to claim 4 and as evidenced by Samuel et al. US 2020/0221749 A1 and as evidenced by Vigsnaes et al. (US 2018/0185396 A1).
35. Regarding claim 14, claim 14, depends on claim 4.
Chichlowski et al. is silent about a total daily dose of 6’-SL.
Sprenger et al. discloses a nutritional composition and a method for oral administration of a nutritional composition for pediatric subject containing HMO comprising 6'SL and can be used alone also ([0141]) as a supplement as unit dose ([0156]). Therefore, it meets claim 4.
It is to be noted that even if Sprenger et al. does not specifically mention 6’-SL promotes development of auditory and/or visual function in an infant /or young child, however, the disclosed sialylated oligosaccharide is 6’-SL which is identical to the claimed 6’-SL and therefore will have identical claimed property including the claimed property of “promoting development of auditory and/or visual function in an infant /or young child . Therefore, Sprenger et al. meets claim 14.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Chichlowski et al. to include the teaching of Sprenger et al. to consider the disclosed amounts of sialylated HMO which includes 6’-SL dose range in order to have an effective sialylated 6’-SL oligosaccharide in the human milk fortifier composition, suitable to supplement milk .
In addition, Sprenger et al. discloses that an oral nutritional composition comprising 3’-SL and 6’-SL ([0128], [0129]) in a ratio between 5:1 to 1:10 ([0130]) and the combined sialylated oligosaccharide can be used 0.05 to 5 gm per 100 gm of composition ([0133]) and can be used alone also ( [0141]) as a supplement as unit dose ([0156]) and daily dose of 0.1 to 2 gm sialylated oligosaccharide ([0191]). The composition can be used as supplement in the infant formula, a starter infant formula, a follow-on formula, a baby food, an infant cereal composition, a fortifier such as a human milk fortifier, or a supplement. In some embodiments, the composition of the invention is an infant formula, or a fortifier or a supplement intended for the first 4 or 6 months of age ([0152], [0166]).
However, the daily dose is optimizable. It is also evidenced by Samuel et al. (e.g. the amount may be tailored to fortify milk [0064]) and Vigsnaes et al. that appropriate dose ranges for such a nutritional component containing composition may be determined by standard method known to those skilled in the art ([0100]).
Therefore, it is within the skill of one of ordinary skill in the art to optimize the daily dose.
Absent showing of unexpected results, the specific daily amount of 6’-SL is not considered to confer patentability to the claims. As the daily requirements are variables which depend on age of the infant, child, body wight, that can be modified, among others, by adjusting the daily amount of 6’-SL, the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the daily amount of 6’-SL, in Sprenger et al., to amounts, including that presently claimed, in order to obtain the daily desired effect e.g. daily nutritional requirement (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Response to arguments
36. Applicants’ arguments and amendments have been considered. Applicants’ arguments and amendments overcome the rejections of record using primary prior art by Chichlowski et al. US 2015/0305385 A1 because Chichlowski et al. discloses probiotic. The amendment of independent claims 1, 2 recite the claim limitation of “wherein probiotics are excluded from the use”
Therefore, for claim 4, only amended independent claim 4 can be addressed using prior used primary prior art by Chichlowski et al. US 2015/0305385 A. The reason is claim 4 does not exclude probiotic. There are no further arguments other than the argument made for Chichlowski et al. The amendments to claim 4 did not change the scope of claim 4. Therefore, the rejection made for claim 4 using Chichlowski et al. US 2015/0305385 A is maintained.
Examiner is using new secondary prior art by Samuel et al. in combination with the primary prior art by Chichlowski et al. to address dependent claims 11,12, 15 which depend on claim 4.
37. Applicants argued on second page about claim 2 that Chichlowski et al. is not unambiguous as to which component improves the audio or visual function in infants. This argument also applies to claim 4.
In response, it is to be noted that art does not have to be unambiguous. It is using the same materials as instantly claimed and discloses that some of the materials used improve audio/visual function in subjects and as such it would be inherent. The disclosed method comprising 6’-SL is identical to the claimed 6’-SL and therefore, the method containing identical 6’-SL containing composition would have identical claimed property for promoting development of auditory and/or visual function in an infant /or young children as claimed in claims 2,4.
38. The new ground of rejection is made using new sets of prior arts are made because of the amendments and considering new claims 7-15. Therefore, the rejection is made as final.
Conclusion
39. One related prior art by Mcconnell et al. (US 20180368460 A1) discloses a synthetic Human milk oligosaccharide comprising 6’-SL is used to treat or prevent viral and/or bacterial infection in a non-infant human; modulating the microbiota of a non-infant human; and/or improving the cognitive function of a non-infant human and as a pharmaceutical or nutritional composition. This prior art does teach its used for non -infant human but not for infant or children.
40. 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). Applicants are reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for replying 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 the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
Prosecution Insights