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 8/28/2025, have been fully considered. Upon review, it was noted that SEQ ID#5 of claim 45 was not addressed. Therefore, a new secondary prior art by Knipples et al. has been used to address claim 45 in this office action. Therefore, the following action is made non-final.
Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.
Status of the application
3. Claims 31-39, 42-45, 47, 50-53 are pending in this office action.
Claims 31, 45 have been amended.
Claims 40, 41, 46, 48, 49, 54-56 are cancelled.
Claims 31-39, 42-45, 47, 50-53 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 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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. 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 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 the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claim (s) 31-39, 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Sado et al. (JP H05209000 A) in view of Bogh et al. (WO 2017/144730 A1) and further in view of Speelmans et al. US 2009/0004164.
8. Regarding claims 31-32, 39, Sado et al. discloses a nutritional composition comprising hypoallergenic peptide which overcomes beta-lactalbumin caused allergy and hypoallergenic peptide is derived from hydrolysis of milk derived protein from whey which includes beta lactalbumin (BLG) protein, and this peptide(s) have no bitterness and has a high nutritional value and thus is useful for nutritional supplement for human and infant (at least on page 2, Under Description, para 2).
Sado et al. also discloses that the allergen beta -lactoglobulin is completely disappeared (page 4, third paragraph) to meet “less than 6 microgram allergen beta- lactoglobulin” as claimed in claim 31. This is optimizable and is discussed below with claim 33.
Sado is silent about specific peptide having claimed SEQ IDs as claimed in claim 31.
Bogh et al. also discloses the hydrolyzed BLG having disclosed SEQ ID #10 LIVTQTMKGLDIQKVAGTWYSLAMAASDISLL (at least in claims 6, 8 of Bogh et al.) which reads on claimed SEQ ID no 2 and also disclosed seq ID # TMKGLDIQKVAGTWYSLAMAASDISLLDAQ (Table 11 of Bogh et al.) contain claimed SEQ ID no 4.
Regarding the method for inducing oral immune tolerance, preventing and reducing oral immune intolerance, and improving or enhancing of oral immune tolerance, as claimed in claim 31, it is to be noted that Bogh et al. discloses a strategy for achieving desensitization or induction of oral tolerance (at least on page 60, line 8) to milk protein allergen betalactoglobuline (BLG) in human or animals comprising formulating and using the one or more purified peptide with food e.g. including milk (at least in Abstract, claims 6, Table 11)
Bogh et al. also discloses (at least on pages 54, 59, in Examples 4 and 5) that oral tolerance is tested in animals by administering intact BLG, either alone or in combination with a small peptide fraction or a large peptide fraction obtained by whey protein hydrolysis. * Co-administration of the intact BLG together with the large peptide fraction results in a great reduction of the sensitizing capacity of the intact BLG (Figure 9), so that "Co-administration of intact BLG with the hydrolysate fraction of large peptides clearly showed a reduced allergenicity compared to administration of the intact BLG alone.
Therefore, Bogh et al. meets claimed steps for the inducing, improving tolerance by preventing and reducing the risk of developing oral tolerance as claimed in claim 31.
Bogh et al. also discloses peptides derived from milk protein e.g., BLG protein as hydrolyzed BLG protein (at least in page 5 lines 24, 25) and BLG is from cow milk (page 4 lines 21-25) which meets “protein hydrolysate from mammalian (cow i.e., BOS Taurus) milk as claimed in claim 31 and it provides desensitization or induction of tolerance to milk allergy (At least in Abstract), therefore, it provides benefit to “human
subject at risk of developing or suffering from milk protein allergy of milk from cow (BOS genus) (page 4 lines 22, 27-28) to meet claim 39.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado’s hydrolyzed BLG by including the teaching of Bogh et al. with the inclusion of hydrolyzed peptide from disclosed SEQ ID # 10 (in Bogh et al. at least in Table 11 and claims 6, 8) which will be effective for the inducing, improving tolerance by preventing and reducing the intolerance caused by intact milk protein also (in Bogh et al. at least in Abstract).
However, Sado et al. in view of Bogh et al. are silent about the claim limitation of “wherein the composition comprises 104-1013 cfu, per g dry weight of the composition, of at least one strain of lactic acid producing, probiotic bacterium which belongs to Bifidobacterium breve” as claimed in claim 31.
Speelmans et al. discloses that a nutritional composition comprising Bifidobacterium breve, in an amount of 102 to 1013 cfu per gm dry weight of the composition (at least in [0023]) of the composition for the prevention of gastric disorder, immune disorder and/or endocrine disorder (At least in Abstract) and can be administered to infants ([0008] even if it is in background section, [0008] recites the disclosed invention, [0063]) in order to achieve a flora in formula-fed infants that is reminiscent to the flora of human milk-fed babies on a Bifidobacterium species level ([0004]). 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).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado et al. in view of Bogh et al. and Knippels et al. to include the teaching of Speelmans et al. who discloses that a nutritional composition comprising Bifidobactrium breve, in an amount of 102 to 1013 cfu per gm dry weight of the composition (at least in [0023]) of the composition for the prevention of gastric disorder, immune disorder and/or endocrine disorder (At least in Abstract) and can be administered to infants ([0008]) in order to achieve a flora in formula-fed infants that is reminiscent to the flora of human milk-fed babies on a Bifidobacterium species level ([0004]).
9. Regarding claims 33, 34, for claim 33, Sado et al. also discloses that the allergen beta - lactoglobulin is completely disappeared (hydrolyzed) (page 4, third paragraph) to meet “less than 3.5 microgram allergen beta-lactoglobulin” as claimed in claim 33.
Sado et al. also discloses that whey protein is composed of various proteins including beta lactalbumin (at least, on page 2, third paragraph, Under Description) Therefore, it would have been obvious that when the beta lactoglobulin is completely disappeared (hydrolyzed), then at least 95 wt.% whey protein will be hydrolyzed which meets “at least 95% by weight hydrolyzed” as claimed in claim 34. It is also within the skill of one of ordinary skill in the art to optimize the hydrolysis in order to have desired amount of hydrolysis so that the final allergenic beta-lactoglobulin remains minimal (nil) including less than 3.5 microgram /gm of total protein.
This is also optimizable and is applicable for claims 31, 33, 34 as addressed using result effective variable and presented below.
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 hydrolysis in Sado et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired degree of hydrolysis as claimed in claim 34 and also an amount of residual allergenic beta — lactoglobulin including less than 6 microgram per gm as claimed in claim 31 and less than 3.5 microgram per gm of total protein for claim 33 (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).
10. Regarding claims 35, 36, Sado et al. also discloses that this hydrolysate having hypoallergenic peptide obtained from whey protein has the characteristics of MW 5000 or more is 10% or less, 500 or less is 20% and 500-5000 is 70% or more (at least on page 4, second paragraph). 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).
11. Regarding claim 37, Sado et al. discloses that the allergen BLG is removed and allergenicity can be reduced to 1/1000 that of natural beta lactoglobulin. This is interpreted as after hydrolysis, a negligible unhydrolyzed beta lactoglobulin is left.
It is also within the skill of one of ordinary skill in the art to optimize the hydrolysis condition in order to achieve a small portion of unhydrolyzed beta lactoglobulin to be left which does not cause allergic situation because of the presence of derived hydrolyzed peptide, however, at the same time, it will have the presence of at least some intact beta lactoglobulin as desired in the composition which can provide nutritional benefit with taste, texture of the final milk close to natural cow milk.
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 residual beta lactoglobulin (BLG) in Sado et al. in view of Bogh et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g., nutritional quality, taste, texture etc. (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).
12. Regarding claim 38, Sado et al. discloses infant formula (at least on page 2 second paragraph, under Description paragraph). Bogh et al. also discloses that the composition can be used for infant formula (at least on page 16, line 32, page 35, paragraphs 2-6) which provides desensitization or induction of tolerance to milk allergy (At least in Abstract).
13. Regarding claim 42, Speelmans et al. discloses that non digestible saccharide can be combinations of Saccharide A with DP 2-8 ([0037], last four lines) and saccharide B having more than 15 DP ([0039]) and saccharide B can be considered as long-chain compared to Saccharide A which, are both can be fructo- oligosaccharide (e.g. chain having units glu-fru and fru) ([0040]) and having mixtures of both of them , provides the benefit of fermentability and stimulation effect on the growth of the Bifidobacteria spp. ([0037]) which is advantageous for an infant nutrition and improves prebiotic stimulation of the intestinal flora at more distal parts of the colon ([0038]).
(Additionally), Bogh et al. discloses that many types of carbohydrates including fructo-oligosaccharide (FOS) can be included such a nutritional product (at least on page 37, line 21).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado et al. to include the teaching of Speelmans et al. (/Bogh) who discloses that mixtures of both of them , small saccharide provides the benefit of fermentability and stimulation effect on the growth of the Bifidobacteria spp. ([0037]) which is advantageous for an infant nutrition and improves prebiotic stimulation of the intestinal flora at more distal parts of the colon ([0038]).
14. Regarding claim 43, Speelman et al. also discloses that the composition can include long chain (LC) polyunsaturated fatty acid in such a composition (at least in [0063]).
(Additionally), Bogh et al. discloses that long -chain polyunsaturated fatty acid including DHA which can be included in such a composition (at least on page 38 mid-section).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado et al. with the teachings of speelman et al. (/Bogh) to consider LC) polyunsaturated fatty acid to be included in such a composition ([0063]) as an energy source and LC) polyunsaturated fatty acid for a proper development of an infant (at least in [0063]).
15. Regarding claim 44, Sado et al. discloses infant formula (at least on page 2 third paragraph, last two lines). Speelman et al. also discloses that the composition can include long chain (LC) polyunsaturated fatty acid for a proper development of an infant (at least in [0063]).
(Additionally), Bogh et al. also discloses that the composition can be used for infant formula (at least on page 16, lines 32-33, page 35, paragraphs 2-7).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado et al. with the teachings of speelman et al. (/Bogh) to consider LC) polyunsaturated fatty acid to be included in such a composition ([0063]) as an energy source and LC) polyunsaturated fatty acid for a proper development of an infant (at least in [0063]).
16. Claim (s) 45, 47, 50-53, are rejected under 35 U.S.C. 103 as being unpatentable over Sado et al. (JP H05209000 A1) in view of Bogh et al. (WO 2017/144730 A1) in view of Knippels et al. (US 2014/0314800) [ABSS Seq search Result, 11/05/2025: Please see Under 227 kb Published Application, result # 9 has this prior art by Knippels et al. Appl. No. 14/362545, US 2014/0314800]) and further in view of Speelmans et al. US 2009/0004164.
17. Regarding independent claim 45, claims 45 (a)-(f) and claim 46 are addressed below:
It is to be noted that Claim 45 (b) is similar to the claim limitation of protein hydrolysate composition portion of the method claim 31. However, claim 45 (b) recites SEQ ID # 5 plus at least anyone peptide having SEQ ID # 3, 4 . This is addressed using Knipple et al. as presented below. The additional claim limitation of “genus Bos’ in claim 45 (b) is additionally addressed below. Therefore, this is addressed first. claim 45 (a) is similar to the strain of claim 31. Therefore, the secondary prior art used to address claim 31 is also used to address claim 45 (a) and discussed below.
Claim 45 (c) similar to the respective “less than 6 micrograms’ of claim 31 and addressed below.
Claim 45 (d) is similar to claim 35 and addressed below.
Claim 45 (e) is similar to claim 34, however it recites “at least 50% by weight also addressed below.
Claim 45 (f) is similar to claims 42. However claim 42 also recites 1-10 wt.% one or more non-digestible oligosaccharide and addressed below.
Claim 45 (g) is optional
Claim 45 (b): Regarding claim 45 (b), Sado et al. discloses a hypoallergenic peptide composition which overcomes beta-lactalbumin caused allergy and hypoallergenic peptide is derived from hydrolysis of milk derived protein from whey which includes beta lactalbumin (BLG) protein, and this peptide(s) have no bitterness and has a high nutritional value and thus is useful for nutritional supplement for human and infant (at least on page 2 Under Description, para 2).
Sado et al. is silent about specific peptide having claimed SEQ IDs as claimed in claim 45 (b).
Bogh et al. discloses peptides derived from milk protein provides desensitization or induction of tolerance to milk allergy (At least in Abstract). Bogh et al. also discloses
that beta lactoglobulin (BLG) secreted in milk from cow (Bos Taurus) (at least on Page 4 last two paragraph).
Bogh et al. also discloses the hydrolyzed BLG having disclosed SEQ ID #10 LIVTQTMKGLDIQKVAGTWYSLAMAASDISLL (at least in Table 11 and claims 6, 8 of Bogh et al.) which reads on claimed SEQ ID no 2 and also disclosed seq ID # TMKGLDIQKVAGTWYSLAMAASDISLLDAQ (page 58, line 1, Table 11 of Bogh et al.) contain claimed SEQ ID no 4.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado’s hydrolyzed BLG by including the teaching of Bogh et al. with the inclusion of hydrolyzed peptide from disclosed SEQ ID # 10 (in Bogh et al. at least in Table 11 and claim 6) which will be effective for the inducing, improving tolerance by preventing and reducing the intolerance caused by intact milk protein also (in Bogh et al. at least in Abstract).
Regarding claim limitation of “ a strain of a lactic acid producing bacterium” as claimed in claim 45, Bogh et al. discloses probiotic (page 24, mid- section) can be included in the composition.
Sado et al. in view of Bogh et al. are silent about the presence of claimed SEQ ID #5.
Knippels et al. discloses that few peptides from BLG e.g., one of them is disclosed SEQ ID #10 having aa 11-42 which includes sequence matching with claimed peptide SEQ ID # 5 (1-30) [ABSS Seq search Result, 11/5/2025: Please see Under 227 kb issued patent, result # 9 has this prior art by Knippels et al.]) has anti allergenic effect (Abstract, SEQ ID #10 and Claim 1 of Knippels et al.) can be used to perform alleviation of acute allergic reaction ([0017]). The disclosures of Knippels et al. can be interpreted as Knippels peptide (s) containing composition can provide treatment regimen for the individuals e.g., infant suffering from cow’s milk protein allergy with improved effects of acute symptom (i.e., severe allergic condition) ([0014], [0017], [0018]) and the acute symptom is mostly reduced or even abolished ([0014]) after treatment and is effective for infant formula or follow-on formula ([0061]). Therefore, the disclosed peptide is very strong anti-allergic peptide.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado et al. in view of Bogh et al. by including the teaching of Knippels et al. by incorporating the additional peptide SEQ ID #10 from Knippels et al. (at least under Sequence listing, last is Seq 10 and it is above the ‘claims start’) in order to provide treatment regimen for the individuals suffering from cow’s milk acute allergic condition ([0014], [0017], [0018]) and it serves as strong anti- allergic peptide as treatment regimen for the individuals suffering from cow's milk protein mediated severe acute allergic condition with improved effects of acute symptom (i.e. severe allergic condition) ([0014], [0017], [0018]) and the acute symptom is mostly reduced or even abolished ([0014]) after treatment and is effective for infant formula or follow-on formula ([0061)).
Claim 45 (c): Regarding claim 45 (c), Sado et al. discloses that the allergen beta -lactoglobulin is completely disappeared (page 4, third paragraph) to meet “less than 6 microgram allergen beta-lactoglobulin.
This is optimizable.
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 hydrolysis in Sado et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired amount of residual allergenic beta — lactoglobulin including less than 6 microgram per gm as claimed in claim 45 (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).
Claim 45 (d): Regarding claim 45 (d), Sado et al. discloses that this hydrolysate having hypoallergenic peptide obtained from whey protein has the characteristics of MW 5000 or more is 10% or less, 500 or less is 20% and 500-5000 is 70% or more (at least on page 4, second para). 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 45 (e): Regarding claim 45 (e), Sado et al. discloses that the beta lactalbumin is completely removed (i.e., hydrolyzed) (at least in page 4 first paragraph) which reads on “at least 50% by weight of hydrolyzed whey protein” of claim 45 (e ).
Claim 45 (g): Regarding claim 45 (g), although optional, however, Bogh et al. discloses that long -chain polyunsaturated fatty acid including DHA which can be included in such a composition (at least on page 23 mid-section).
Claim 45 (a): Regarding claim 45 (a), Sado et al. in view of Bogh et al. disclose probiotic (in Bogh et al. page 24, mid-section) can be included in the composition.
However, Sado et al. in view of Bogh et al. are silent about lactic acid producing bacteria belongs to the species Bifidobacterium breve as claimed in claim 45 (a).
Speelmans et al. discloses that a nutritional composition comprising Bifidobactrium breve, in an amount of 102 to 1013 cfu per gm dry weight of the composition (at least in [0023]) of the composition for the prevention of gastric disorder, immune disorder and/or endocrine disorder (At least in Abstract) and can be administered to infants ([0008]) in order to achieve a flora in formula-fed infants that is reminiscent to the flora of human milk-fed babies on a Bifidobacterium species level ([0004]). 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).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado et al. in view of Bogh et al. and Knippels et al. to include the teaching of Speelmans et al. who discloses that a nutritional composition comprising Bifidobactrium breve, in an amount of 102 to 1013 cfu per gm dry weight of the composition (at least in [0023]) of the composition for the prevention of gastric disorder, immune disorder and/or endocrine disorder (At least in Abstract) and can be administered to infants ([0008]) in order to achieve a flora in formula-fed infants that is reminiscent to the flora of human milk-fed babies on a Bifidobacterium species level ([0004]).
Claim 45 (f): Sado et al. in view of Bogh et al. are silent about the claim limitation of amended claim 45 (f).
Speelmans et al. discloses that non digestible saccharide can be combinations of Saccharide A with DP 2-8 ([0037], last four lines) and saccharide B having more than 15 DP ([0039]) and saccharide B can be considered as long-chain compared to Saccharide A which, are both can be fructo oligosaccharide (e.g. chain having units glu-fru and fru) ([0040]) and having mixtures of both of them , small saccharide provides the benefit of fermentability and stimulation effect on the growth of the Bifidobacteria spp. ([0037]) and large saccharide provides the benefit of reducing the osmotic load, which is advantageous for an infant nutrition and improves prebiotic stimulation of the intestinal flora at more distal parts of the colon ([0038]).
Regarding the amount, Speelman et al. discloses that the amount of combinations of these two saccharides A and B can be 0.1 to 30 gm at a daily dose ([0048]). Speelmans et al. also discloses that the composition comprises at least 5 mg each of the first and second non-digestible saccharide per 100 ml (at least in claim 27 of Speelmans et al.). Spelman’s et al. also discloses that the nutritional composition can be in dry powder form and water can be incorporated as per desired viscosity choice of the final product ([0019]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sado et al. in view of Bogh et al. and Knippels et al. to include the teaching of Speelmans et al. who discloses that mixtures of both of them , small saccharide provides the benefit of fermentability and stimulation effect on the growth of the Bifidobacteria spp. ([0037]) and large saccharide provides the benefit of reducing the osmotic load, which is advantageous for an infant nutrition and improves prebiotic stimulation of the intestinal flora at more distal parts of the colon ([0038]).
Therefore, it is within the skill of one of ordinary skill in the art can optimize the amount in the dry powder form from the broad disclosure of the amount of combinations of these two saccharides A and B can be 0.1 to 30 gm at a daily dose ([0048]) which will meet the claimed range amount of 1 to 10wt.% of the one or more non-digestible oligosaccharide as claimed in claim 45 (f). It is also optimizable.
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 non-digestible oligosaccharides in Sado et al. in view of Bogh et al. and Knippels et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired daily dose for the prebiotic effect. (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).
18. Regarding claim 47, Sado et al. discloses that the allergen BLG is removed and allergenicity can be reduced to 1/1000 that of natural beta lactoglobulin (page 4 third paragraph). This is interpreted as after hydrolysis, a negligible unhydrolyzed beta lactoglobulin is left. It is also within the skill of one of ordinary skill in the art to optimize the hydrolysis condition in order to achieve a small portion of unhydrolyzed beta lactoglobulin to be left which does not cause allergic situation because of the presence of derived hydrolyzed peptide, however, at the same time, it will have the presence of at least some intact beta lactoglobulin as desired in the composition which can provide some close taste, texture and nutritional quality of natural cow milk.
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 residual beta lactoglobulin (BLG) in Sado in view of Bogh to amounts, including that presently claimed, in order to obtain the desired effect e.g., nutritional quality, taste, texture etc. (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).
Although optional, claim 47 also claims “more than 1wt% of peptides or proteins with a size of 1 kDa’. Sado et al. also discloses that this hydrolysate having
hypoallergenic peptide obtained from whey protein has the characteristics of MW 5000 or more is 10% or less, 500 or less is 20% and 500-5000 is 70% or more (at least on page 4, second paragraph). 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).
19. Regarding claims 50, 52, Sado et al. discloses infant formula (at least on page 2 under Description, para 2, last two lines). Bogh et al. also discloses that the composition can be used for infant formula (at least on page 16, lines 32-33, page 35, paragraphs 2- 7).
20. Regarding claim 51, therefore, the disclosed method of administering this nutritional composition as disclosed by Bogh et al. (at least in Examples 4,5) will provide nutrition toa human subject at risk of developing or suffering from allergy as claimed in claim 51.
21. Regarding claim 53, Sado et al. discloses milk protein allergy (at least in second page Under Description, three paragraphs). Bogh et al. also discloses milk protein allergy (at least under Summary of the Invention, first two lines). Therefore, the allergy is milk protein allergy as claimed in claim 53.
Response to arguments
22. It is to be noted that ODP rejection made with application number 17/051180 is withdrawn because application number 17/051180 was abandoned on 9/11/2025.
23. Applicants primarily argued in Remarks, page 2, about unexpected result.
Applicants argued that “ The conclusion is based on tests in the experimental part of the application. To confirm that the peptides identified in the hydrolyzed protein were recognized by T cells, synthetic peptides with identical sequences were tested on cow's milk-specific human TCLs from three different donors. Five peptides were tested which differed by more than 9 amino acids from each other and all peptides (SEQ ID NOs: 9 (1 with X = L), , 3, 4 and 5, see table 7) were able to induce proliferation. All peptides were able to induce proliferation of TCL B and four out of the five induced proliferation in TCL A. SEQ ID NO 5 induced proliferation of TLC C the best. Further, a mixture of the claimed specific HLA-DR-restricted BLG peptides would be able to induce a desired diverse recognition by T cells. It is thus the combination of features a) and b) as defined here above that results in the unexpected effect. This effect cannot be predicted by prior art documents that recite only one of the two. Applicant reserves the right to present such arguments later during prosecution or appeal. Reconsideration and withdrawal of the rejection is respectfully requested”.
In response, first, itidentical claimed property including the enhanced combined effect of immune tolerance when the two claimed peptides are used compared to only one of them.
Second, regarding the unexpected result, applicants have not established, at least, the “synergistic effect’ or additive effect by considering the combinations of claimed SEQ ID # 5 with at least one of peptide from SEQ ID #s 3or 4 for claim 45.
In brief, in the applicant’s specification, it is mentioned that SEQ ID #5 is important as TCL A only recognize SEQ ID #5 (at least in [0195] e.g. “TCL A should only recognize AA#11-42 which is SEQ ID #5, See Table 7), however, this TCL A showed a proliferation response after stimulation with four (e.g., Table 7, SEQ ID#s 9,11,3, 4) of the five peptides only (Table 7 and [0195]). Therefore, even if it is understood that SEQ ID# 5 performs its function in combination with SEQ ID #3, 4, the experimental result is expected when the combined teaching meets claimed invention. In this instance, it is understood from the applicant’s specification that SEQ ID #5 peptide recognize TCL A only and showed proliferation after stimulation with anyone of SEQ ID #3, 4 (Table 7, [(0195]). Therefore, the combined effect of SEQ ID #5 with SEQ ID #3 or 4 shows proliferation of TCL A. This is expected result because the combined teaching meets claimed invention as discussed in the office action.
(3) Also, it is to be noted that according to MPEP 716.02 (a), “A greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicant has not shown that the results shown would be greater than those which would have been expected from the prior art to an unobvious extent.
(4) Applicants may establish the criticality of the Bifidobacterium breve M-16v (Morinaga) strain (in PGPUB [0213]) as broadly claimed in claims 31, 45 and/or in combination with the amounts and ratio of Sc/Lc FOS and the claimed peptides as may be used in the formulation as presented in the applicant’s specification ([in PGPUB at least in [0201], [0202]).
Therefore, and as discussed above, the evidence of unexpected results must be clear and convincing. In re Lohr 137 USPQ 548. Evidence of unexpected results must be commensurate in scope with the subject matter claimed. In re Linder 173 USPQ 356.
Therefore, unexpected result is not sufficient to overcome the rejections of record.
Applicants do not have any further arguments. The rejection is made as non-final.
Conclusion
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792