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 3/19/2026, 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Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.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, 6-21 are pending in this application.
Claims 1-4, 6-16 have been amended.
Claim 5 is cancelled.
Claims 17-21 are new
Claims 1-4, 6-21 have been rejected.
Claim Rejections - 35 USC § 103
4. 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.
5. 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.
6. 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 non-obviousness.
7. Claim(s) 1, 4-21 are rejected under 35 U.S.C. 103 as being unpatentable over Brosnan et al. (US 2020/0404946) in view of Erdmann et al. USPN 6787158 in view of Kawaski et al. JP H11103794 A and further in view of Dong et al. CN 104489101 A.
8. Regarding claims 1, 4, 5, 6, 7-11, Brosnan et al. discloses (claims 1-16; examples 1-5, [0040]-[0079]) the use of a milk protein fraction as a source of osteopontin (OPN) in ‘a synthetic nutritional composition’ ([0061]) for infants or children. Brosnan et al. also discloses the amount of OPN is at least 10 mg/l ( at least in [0040], [0061]) which concentration of osteopontin matches in a range as in human breast milk or in a higher concentration and the infant formula contains 1.6-3.8g/L milk protein (e.g. whey protein) (at least in [0052], [0054]). One of ordinary skill in the art would have been motivated to make “synthetic nutritional composition as a source of osteopontin with a reasonable expectation of success to provide osteopontin amount at least equivalent to or more than human breast milk ([0061]).
Therefore, Brosnan et al. discloses a method of making “synthetic nutritional composition with osteopontin” as a source of osteopontin as claimed in claim 1 and also it meets claim limitation of “ A method for providing nutrition to an infant or child comprising administering a synthetic nutritional composition” as claimed in claims 1, 6.
Brosnan et al. is silent about the sequential steps for producing “a milk protein fraction as a source of Osteopontin” as claimed in independent claims 1, 6.
It is evidenced by applicants that “A milk protein fraction enriched in CGMP” is herein defined as a milk protein fraction that has been processed to increase the amount of cGMP in the milk protein fraction compared to the un-processed lactic raw material (at least in PGPUB [0045]).
Erdmann et al. discloses a method to isolate purified form of cGMP from lactic raw material which includes sweet whey which is “a milk protein fraction as a source of Osteopontin” by making it free from cation at pH 1.09 ( at least under col 3 lines 12-26 and col 8, Ex 5 lines 44-45) followed by contacting with an anionic resin having hydrophobic matrix for a sufficient amount of time to absorb a substantial amount of cGMP followed by separating adsorbed GMP material (i.e. the claimed step of desorption) (at least in claim 1, 5, 8, 13, 14 and 16 etc. of Erdmann et al.). Therefore, it meets claim 1(i)- (v) and claim 6 (i)-(v).
Erdmann et al. also discloses that the contact with the resin can be performed at pH 4.5-5.5 (at least in claim 7 of Erdmann et al.) which meets claimed stabilized pH where adsorption of CGMP occurs with the anionic resin at the pH under stable condition.
It is to be noted that and as evidenced by applicant’s specification that the pH 4.5 4.5 is stabilized pH ([0048] in PGPUB). Erdmann et al. also discloses that the contact with the resin can be performed at pH 4.5-5.5 (at least in claim 7 of Erdmann et al.). Therefore, one of ordinary skill in the art would have been motivated to bring the pH at 4.5 after the step of decationization step as disclosed by Erdmann et al. which meets claimed step of claim 1 (ii), bringing to 4.5 at the step of contacting with a week anionic resin in order to have good binding of cGMP with the resin at the step of claim 1 (iii) and claim 6 (iii).
It is also to be noted that the disclosed combined teachings of prior arts of record meets the claim limitation of the claimed invention, therefore, the disclosed product having identical property of the claimed product and it would necessarily result in a pH level where it is stabilized including the claimed pH level.
The isolation of CGMP is taught by Erdmann et al. as discussed above.
It is to be noted that Erdmann et al. also discloses that after combining the eluate and washing volumes, the volume is concentrated using ultrafiltration or nanofiltration technique to make pure GMP with high yield (col 6 lines 43-45) to obtain an improved protein product suitable for its use in foods (Abstract).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Brosnan et al. to include the teaching of Erdmann et al.to perform the disclosed steps which meet claimed sequential steps to separate CGMP from sweet whey to obtain an improved protein product suitable for its use in foods (at least in Abstract) and also suitable for its further use e.g. ready to process further to make osteopontin as discussed below.
Erdmann et al. disclose that the disclosed ‘the milk protein fraction’ which is osteopontin enriched CGMP fraction which is further purified by using the teachings of Kawaski et al. and Dong et al. to make osteopontin as discussed below which is included into the synthetic nutritional composition to modify Brosnan et al. ([0061]) to serve as a source of osteopontin in the milk composition.
Brosnan et al. in view of Erdmann et al. do not teach further separation steps (vi) and (vii) of claims 1, 6, to separate osteopontin from cGMP.
As discussed above, after the pure CGMP is made, one of ordinary skill in the art would have been motivated to consider this pure CGMP to proceed for the further steps of UF to enrich and collect OPN of the claimed invention.
Kawaski et al. discloses ( [0010]-[0012]) that an ultrafiltration membrane having a cut-off molecular weight of 10,000 to 50,000 is used for purifying cGMP.
Dong et al. discloses ([0022]) that osteopontin molecular weight in the cow milk is 41. 5kD. Therefore, one of ordinary skill in the art would have been motivated to include the teachings of Dong et al. to select proper membrane size by optimizing from within the disclosed range values of membrane cut-off values based on their MWs in order to achieve the maximum concentration of osteopontin in the retentate fraction. The reason is 41.5 kDa Osteopontin is retained if the membrane size is between claimed range size of claim 4. Therefore, it meets the steps (vi) –(vii) of claims 1, 6.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Brosnan et al. in view of Erdmann et al. to include the teaching of KAWASAKI et al. (at least in [0010]) and Dong et al. ([0022]) to select proper membrane size by optimizing from within the disclosed range values of membrane cut-off values based on their MWs in order to achieve the maximum concentration of osteopontin in the retentate fraction.
9. Regarding claims 7-11, Erdmann et al. disclose that the disclosed ‘the milk protein fraction’ which is osteopontin enriched CGMP fraction which is further purified by using the teachings of KAWASAKI et al. Dong et al. to make osteopontin as discussed above and included into the synthetic nutritional composition to modify Brosnan et al. ([0061]) to serve as a source of osteopontin in the milk composition.
10. Regarding claims 7-9, Brosnan et al. discloses that the total protein content in the synthetic nutritional composition can be between 12.5%-95% of the nutritional composition ([0075]).
11. Regarding claim 10, Bronson et al. discloses that the amount is age based (at least [0063]) and the protein content in the synthetic nutritional composition may be at most 20g/L, therefore, it is optimizable (at least [0042]).
12. Regarding claim 11, Brosnan et al. discloses that osteopontin 10-350 mg/L which matches with the amount present in human breast milk ([0040]) and the amount is age based (at least [0063]) and the protein content in the synthetic nutritional composition may be at most 20g/L, therefore, it is optimizable (at least [0042]). Brosnan et al. also discloses that the total protein content in the synthetic nutritional composition can be between 12.5%-95% of the nutritional composition ([0075]) and it can include growing up milk etc. (at least [0071]) which can contribute more milk protein in addition to above mentioned alpha lactalbumin ([0064]) with osteopontin 10-350 mg/L which matches with the amount present in human breast milk ([0040]).
For claims 7-11 above, it is to be noted that Brosnan et al. also discloses the amount of OPN is at least 10 mg/l ( at least in [0040], [0061]) which concentration of osteopontin matches in a range as in human breast milk or in a higher concentration and the infant formula contains 1.6-3.8g/L milk protein (e.g. whey protein) (at least in [0052], [0054]). One of ordinary skill in the art would have been motivated to make “synthetic nutritional composition as a source of osteopontin with a reasonable expectation of success to provide osteopontin amount at least equivalent to or more than human breast milk ([0061]) suitable for the new born baby and also for the children in the age group as claimed in claims 7-11.
13. Regarding new claims 18-21, regarding the age the children, Brosnan et al. discloses that the age can vary up to 12 months for infant (at least [0045]) and 1-18 years for children (at least [0047]).
Claims 18-21 depend on claims 7-11. As discussed for claims 7-11 above, it is applicable for claims 18-21 also. Claims 18-21 the new claims having claim limitations from the deleted portions of the amended claims 7-11 respectively.
Therefore, the amount of osteopontin in ultrafiltered CGMP which can contribute required sialic acid which are age dependent of the new born and infant , children .
Therefore, claims 7-11, 18-21 are optimizable based on the amount of osteopontin and age.
Absent showing of unexpected results, the specific amount of “milk protein fraction” as claimed in claims 7-10 and Osteopontin concentration as claimed in claim 11 are not considered to confer patentability to the claims. As the amount of CGMP and/or osteopontin in “milk protein fraction” are variables and depend on the age of infant , that can be modified, among others, by adjusting the amount of milk protein fraction (osteopontin for claim 11), 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 amount of “milk protein fraction” in Bronson et al. in view of Erdmann et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired amount in the fraction after UF enriched with enriched amount of osteopontin in ultrafiltered CGMP which can contribute required sialic acid which are age dependent to provide nutritionally enriched foods including infant formula (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).
14. Regarding claim 12, Brosnan et al. also discloses that the synthetic nutritional composition can be combined with other milk composition e.g. human breast milk (HM) fortifier, growing up milk etc. and disclosed “may be employed” ([0071]) can be interpreted as its use alone also which meets claim 12.
15. Regarding claims 13-16, it is to be noted that claims 13-16 recite the claim limitations of “A method to promote and/or optimize the growth” and/or optimize immune defense in an infant or child to whom it is administered” as claimed in claim 13 , “A method to promote and/or optimize the growth” and/or the development in an infant or child to whom it is administered” as claimed in claim 14 , “A method to promote and/or optimize the galactose metabolism a in an infant or child to whom it is administered” as claimed in claim 15, A method to promote and/or optimize cytoskeletal remodelling” as claimed in claim 16 are use claims and discussed above. It is also to be noted that the disclosed method using the disclosed ingredients which make the disclosed synthetic nutritional composition are identical to the claimed method with the identical claimed ingredient and claimed synthetic nutritional composition and therefore, it will have the identical claimed property of “A method to promote and/or optimize the growth” and/or optimize immune defense in an infant or child to whom it is administered” as claimed in claim 13 , “A method to promote and/or optimize the growth” and/or the development in an infant or child to whom it is administered” as claimed in claim 14 , “A method to promote and/or optimize the galactose metabolism a in an infant or child to whom it is administered” as claimed in claim 15, A method to promote and/or optimize cytoskeletal remodeling” as claimed in claim 16.
16. Regarding new claim 17, Brosnan et al. discloses that the synthetic nutritional composition comprises osteopontin concentration in a range as in human breast milk or in a higher concentration ([0061]). Brosnan et al. also discloses the synthetic nutritional composition may comprise osteopontin in a concentration of 10 mg/L or more, for example from 10 to 400 mg/L, from 10 to 350 mg/L, from 10 to 325 mg/L or from 10 to 322 mg/L.([0061]). However, Brosnan et al. also discloses the effective amount of osteopontin in the synthetic nutritional composition can be considered which is well within the skill of the skilled person to determine an effective amount taking into consideration the concentration of osteopontin, and when appropriate reconstitution instructions for the synthetic nutritional composition ([0056]).
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 amount of “effective amount of final concentration of osteopontin ” in Bronson et al., to amounts, including that presently claimed, which is an effective amount based on the reconstitution instructions (in Brosnan et al. [0056]) in order to obtain the desired effect e.g. desired amount of osteopontin amount in the synthetic nutritional composition in order to provide nutritionally enriched foods including infant formula (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).
17. Claims 2, 3 are rejected under 35 U.S.C. 103 as being unpatentable over Brosnan et al. (US 2020/0404946) in view of Erdmann et al. USPN 6787158 in view of Kawasaki et al. JP H11103794 A and further in view of Dong et al. CN 104489101 A as applied to claim 1 and further in view of Sorensen et al. USPN 7259243.
18. Regarding claims 2, 3, Erdmann et al. also discloses that after the separation of cGMP from the resin (col 4 lines 65-67), and desorption accompanies the addition of calcium hydroxide which process advantageously regenerates the resin also ( col 5 lines 8-12). Erdmann et al. also discloses that after combining the eluate and washing volumes, the volume is concentrated using ultrafiltration or nanofiltration technique (col 6 lines 43-45).
However, they are specifically silent about the claim limitation of claims 2, 3.
Sorensen et al. discloses that calcium is mixed in milk material by adjusting pH to keep osteopontin in solution (col 2 35-40). Sorensen et al. also discloses that osteopontin is in solution at pH 4.0-4.6 (col 3 lines 32-34).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Brosnan et al. in view of Erdmann et al. to include the teaching of Sorensen et al. to consider addition of calcium at the disclosed pH value in order to keep osteopontin in solution (col 2 35-40) which is beneficial for the separation using UF method.
Response to arguments
19. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments overcome 112 second paragraph rejections of record. Applicants arguments and amendment do not overcome the rejections made by the prior combinations of prior arts of record used in the last office action to make the 103 obviousness rejections in the last Non- Final office action. The identical combinations of prior arts have also been used to address new claims 17-21 in this office action.
20. Applicants primarily argued in two pages arguments as filed on 3/19/2026 that “ the skilled artisan would not have combined the cited references to arrive at the present claims”. Applicants also argued that Erdman’s method step will not produce the same composition disclosed in Brosnan et al.
In response, applicants’ arguments are considered. There are no specific detailed arguments made for the obviousness rejection and for individual prior arts of record. Applicants did not mention why Brosnan is deficient. Examiner does not agree with the allegations made by the applicants that Brosnan and Erdmann are not combinable and Erdman’s method step will not produce the same composition disclosed in Brosnan et al.
Regarding the substance of the examiner’s obviousness rejection as argued on
page 2 of the remarks, the requirements for obviousness are discussed in MPEP
§ 2142.
As explained in the previous Office Action, the only difference between
claim 1, 6 and the teachings of Brosnan et al. is the method of making osteopontin with the claimed sequential steps for producing a pure form of osteopontin to be used for nutritional element in food. Like the claimed invention, both Brosnan and Erdmann et al.
are directed to osteopontin in infant formula product. One of ordinary skill in the
art would reasonably have expected that substituting the method steps to modify Brosnan to make osteopontin as taught by Erdmann et al. for the use in food composition would have been within the skill of the art and yielded the predictable result of having high yield concentrated osteopontin suitable to be used in infant’s formulation food product. The rejection of claim 1 as obvious over Brosnan in view of Erdmann et al., is, therefore, maintained.
21. Response to attached e mail from applicant’s in relation to interview on May 4, 2026 (attached Interview summary and Annexure I containing e mail):
Examiner conducted applicant’s request for an interview held on last May 4, 2026. However, applicants further sent an e mail to further share few points to be considered (See attached interview summary and attached Annexure I). Examiner has attached this e mail and considered as an extended argument and responded in this section.
In the email (attached as Annexure I), applicant claims that applicant’s unique findings of OPN to be in the permeate instead of retentate even if the size of OPN (34-70 kDa) is expected to be in the retentate fraction. Applicant claims this as unexpected result.
In response, Examiner does not agree. The reasons are,
(a) Examiner has agreed the arguments made that “even if cGMP has small size 8kDa, yet it agglomerates to have large size” as mentioned in the attached e mail which is in support of the applicant’s specification ([[0181]). Therefore, cGMP may be retained in the retentate using the higher MW cut-off size ( Annexure I: See bold lines containing PGPUB [0181], as mentioned in the attached e mail from applicants (Annexure I).
(b) However, it is not convincing. The reason is and as mentioned in the office action above that Dong et al. discloses ([0022]) that osteopontin molecular weight in the cow milk is 41.5kD. Therefore, one of ordinary skill in the art would have been motivated to include the teachings of Dong et al. to select proper membrane size by optimizing from within the disclosed range values of membrane cut-off values based on their MWs in order to achieve the maximum concentration of osteopontin in the retentate fraction.
22. Applicants do not have any further arguments in the two pages arguments as filed on 3/19/2026.
Therefore, the rejection is made as final.
Conclusion
23. 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 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