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 7/24/2025, 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Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.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, 4-10, 15, 16, 18, 19 are pending in this office action.
Claim 18 have been further amended.
Claims 2, 3,11-14, 17, 20 have been cancelled.
Claims 1, 4-10, 15, 16, 18, 19 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-AlA) 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 that 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(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 the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claims 1, 4-8, 15, 16, 18, 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (JP 2007143464 A: machine translation of Sakamoto et al. (filed on 2/16/2022) and further in view of Joergensen et al. CN 1897819 A (2007-01-17) and further (alternatively) in view of Dalboge H et al. US 2004/0253344 and as evidenced by NPL ppm vs mass percent.
8. Regarding claims 1, 4-6, 15, 16, 18, 19, Sakamoto et al. discloses that a beverage including tea beverage can be made by incorporating hyaluronic acid or its salts in an amount of 0.1% by mass or less to provide taste masking effect (at least on page 4, fifth paragraph e.g. “masking effect is observed”) as taste improving agent to improve tastes to overcome unwanted tastes including astringent taste also (at least on page 1, paragraph 9, 10) to meet claim limitation of “masking perceived astringency” as claimed in claim 1. It is to be noted and as evidenced by NPL ppm vs mass percent that 0.1 % by mass or less is 1000 ppm or less (page 1) which meets the claimed range amount of claim 1, 16, 19. 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).
Absent showing of unexpected results, the specific amount of concentration of hyaluronic acid/salt in a “concentration of about 50 ppm to about 500 ppm” are not considered to confer patentability to the claims 1, 16 and 19. As the “masking perceived astringency and undesired off-notes” is variable that can be modified, among others, by adjusting the amount of “hyaluronic acid/salt” , the precise amount of hyaluronic acid/salt 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 size of the hyaluronic acid /salt in Sakamoto et al., to amounts, including that presently claimed, in order to obtain the desirable masking effect to mask undesired off-notes (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).
Sakamoto et al. also discloses that the average MW is 600 kDa to 1,200 kDa in order to obtain the desirable controlled size (page 3 paragraph 4) which overlaps claim limitations of claims 1, 15, 17 and 18. 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).
Absent showing of unexpected results, the specific average MW 500 kDa or more and also 1000 kDa -1400kDa are not considered to confer patentability to the claims 1, 15, 17 and 18. As the size is variable that can be modified, among others, by adjusting the hydrolysis condition e.g., degree of hydrolysis etc., the precise size 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 size of the hyaluronic acid /salt in Sakamoto et al., to amounts, including that presently claimed, in order to obtain the desirable controlled size (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).
Regarding independent claims 1, 15 and 18, Sakamoto et al. is silent about “wherein the consumable composition or additive comprises a meat analogue or yogurt”.
Joergensen et al. discloses the method of making dairy products including yogurt with the addition of hyaluronic acid salt and the food product can be “juice beverage (sorbet), or yogurt, and “plant component” such as It has dairy product may contain “plant protein’ also (Page 5, para 2 , page 3 para 10) and the amount is 0.01 to 0.02% hyaluronic acid/salt added to milk (page 6 last para and Table 1) and the amount of hyaluronic acid can be broad in the range of products is 0.001-10 % (weight/weight) (page 2 last two paragraphs). Joergensen et al. discloses that the yogurt containing hyaluronic acid/salt provides health benefits and also (page 2, and first few paragraphs).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sakamoto et al. by including the teaching of Joergensen et al. who discloses that dairy products including yogurt can be made with the addition of hyaluronic acid salt and “the dairy product may include “plant protein’ also (Page 5, para 2 , page 3 para 10) because the yogurt containing hyaluronic acid/salt provides health benefits and also (page 2, and first few paragraphs).
(Alternatively), Dalboge et al. discloses that a dairy product e.g., yogurt comprising Hyaluronic acid provides an improved texture and/or mouthfeel of yogurt (at least in Abstract, [0043] and [0070] e.g., Sodium hyaluronate, and claim 8 of Dalboge et al.). Dalboge et al. also discloses that a dairy product e.g., yogurt can include vegetable protein as a source of vegetable protein additive in yogurt (at least in [0027] of Dalboge et al.).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sakamoto et al. (at least in page 5 third paragraph) to include the teaching of Dalboge et al. who discloses that a dairy product e.g., yogurt to in order to make yogurt with the substitution of meat analogue vegetable protein, e.g. soy protein as additive to make yogurt beverage with soy to provide meat analogue vegetable protein and desired soy flavored yogurt containing Hayaluronic acid provides an improved texture and/or mouthfeel of yogurt (at least in Abstract, [0043] and [0070] e.g., Sodium hyaluronate, and claim 8 of Dalboge et al.).
It is to be noted that even if the secondary prior arts by Joergensen et al. and/or (alternatively), Dalboge et al. do not specifically mention that hyaluronic acid/salt provides masking effect to mask undesired off-notes in food, however they are used, with teaching suggestive motivation to teach that yogurt can be made using hyaluronic acid/salt. Therefore, as because the presence of disclosed amount of hyaluronic acid/salt in food including yogurt meet the claimed amount of hyaluronic acid/salt, it would have inherent claimed property including the claimed property of “masking undesired off-taste” also.
According to MPEP 2143.01, “Obviousness can be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis). Axonics, Inc. v. Medtronic, Inc., 73 F.4th 950, 957-58, 2023 USPQ2d 795 (Fed. Cir. 2023) (the court found an erroneous framing of the motivation inquiry led to an incorrect conclusion of nonobviousness)”.
Regarding the amended claim 18, claim 18 recites “ astringent-masker consisting of”. It is to be noted that the independent claim 18 recites the open ended transitional phrase “comprising” at the beginning after “A consumable composition” and the close ended transitional phrase “consisting of” only limits the “stringency masker”. Therefore, the presence of other components not indicated as an astringency masker can be included in the ‘consumable composition’ under the current claim construction of claim 18.
Therefore, even if the amended claim 18 recites “close ended transitional phrase ‘consisting of” with respect to the astringent-masker hyaluronic acid, however, as discussed above, Sakamoto et al. discloses that a beverage(s) can be made by incorporating hyaluronic acid or its salts in an amount of 0.1% by mass or less to provide taste masking effect (at least on page 4, fifth paragraph e.g. “masking effect is observed”). Sakamoto et al. is primary prior art and Sakamoto teaches taste masking effect is provided only by hyaluronic acid which is superior to other agents (at least on page 1, last paragraph of Sakamoto et al.).
9. Regarding claims 1, 4-5, it is to be noted and as mentioned above that Sakamoto et al. discloses that a beverage including tea beverage can be made by incorporating hyaluronic acid or its salts in an amount of 0.1% by mass or less (at least on page 4, fifth paragraph). Therefore, this range amount of hyaluronic acid can be considered as taste improving agent to improve tastes to overcome unwanted tastes including astringent taste also (at least on page 1, paragraph 9, 10) to meet claim limitation of “masking perceived astringency”.
Sakamoto et al. also discloses that hyaluronic acid or its salts in an amount of 0.1% by mass or less to provide taste masking effect (at least on page 4, fifth paragraph e.g., “masking effect is observed’). Therefore, Sakamoto et al. discloses both the alternatives as acid or salt form of hyaluronic acid are active to perform taste improving agent to improve tastes to overcome unwanted tastes including astringent taste also (at least on page 1, paragraph 9, 10) to meet claims 1,4,5.
10. Regarding claim 6, it is to be noted that and as it is known to one of ordinary skill in this art that the (i) if we look at the analytical report of the final product which is made by converting hyaluronic acid from its acid form to salt form (e.g. alkali sodium salt) can have some acid form left with the salt in the final product and (ii) Hyaluronic acid is weak acid and when the salt form is in liquid (water), salt form will be present partly in the acid form due to hydrolysis and therefore, it will be both ‘hyaluronic acid and a salt thereof” as claimed in claim 6.
It is also to be noted that claimed “the astringent-masking amount of hyaluronic acid and/or salt thereof” as claimed in claims 1,2, 4-6 are also within the skill of one of ordinary skill in the art, and, therefore, it is optimizable. Absent showing of unexpected results, the specific amount of hyaluronic acid and/or salt is not considered to confer patentability to the claims. As the taste, texture are variables that can be modified, among others, by adjusting the amount of hyaluronic acid and/or salt, 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 hyaluronic acid and/or salt in Sakamoto et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g., taste, texture etc. (5). (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).
11. Regarding claims 7, 8, Joergensen et al. discloses it can be sodium hyaluronate also (Page 3, second paragraph Sodium hyaluronate) to meet claim 8.
12. Claims 9, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sakamoto et al. (JP 2007143464 A) and further in view of Joergensen et al. CN 1897819 A (2007-01-17) and further (additionally) in view of Dalboge H et al. US 2004/0253344as applied to claim 1 and further in view of Bach P et al. (US 2005/0272695).
13. Regarding claims 9, 10, Sakamoto et al. discloses that hyaluronic acid or its salt form is dried (page 4 second paragraph) and mixed with powdered beverage (page 5
paragraph 4). It is also to be noted that Joergensen et al. also discloses that the raw material hyaluronic acid salt can be used. Therefore, it is considered as an implicit disclosure that the dry hyaluronic acid (HA) or salt form can also be in powder form to be mixed with powdered beverage.
However, more specifically, Sakamoto et al. is silent about the claim limitations of claims 9 and 10.
Bach P et al. discloses that the HA product can be in spray-dried form which provides the benefit of greatly improves the solubility of the product, thus achieving very fast dissolution in aqueous solvent ([0015], [0016]) to be used in food ([0095]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sakamoto et al. to include the teaching of Bach P et al. to consider spray-dried powder form of HA product can be in spray- dried form which provides the benefit of greatly improves the solubility of the product, thus achieving very fast dissolution in aqueous solvent ([0015], [0016]) to be used in various applications including food also ([0095]).
Pertinent prior art(s) notes
14. Jeoung et al. (KR 20080074583 A)
[Used in the last office action. Withdrawn due to amendment of claims 1,18 with the claim limitation “a meat analogue or yogurt”].
Response to arguments
15. Applicant’s arguments and amendments have been considered. However, they are not persuasive. Applicants argued on second page, first paragraph that
(a) “Manufacturers often add sweeteners, such as aspartame, stevia, or sucralose, to a powdered drink to mask these undesired tastes. High amounts of these sweeteners must be used in the powdered drink to mask the undesired tastes. However, the addition of high amounts of the sweetener imparts undesired tastes of their own. Manufacturers are forced to add further agents to the powdered drink to overcome the undesired tastes imparted by the sweeteners. Accordingly, the problem faced by Sakamoto is masking undesired tastes in powdered drinks. The problem faced by Joergensen is improving the texture of a dairy product.
(b) Joergensen discloses adding a combination of hyaluronic acid as a first
texturizer with a second texturizer. The combined first and second texturizers supposedly provide a suitable texture to a dairy product. Suitable second texturizers may be selected from start, modifier starch, pectic, carrageenan, locust bean gum, alginate, albumin, agar agar, xanthan gum, guar gum, konjac, microcrystalline cellulose, chitin, and chitosan. Joegensen specifically requires a combination of hyaluronic acid and a second texturizer to achieve the improvement in texture of a dairy product (“The present invention has found that when hyaluronic acid and a second tissue-forming agent are added to a dairy product, it affects the tissue characteristics of the dairy product to a greater degree than is achieved by adding hyaluronic acid or the second tissue-forming agent alone.”)”.
(c) On third page, first paragraph applicants argued that “ Dalboge is directed to a dairy product comprising hyaluronic acid and one or more milk components. Like Joergensen, Dalboge is only concerned with improved texture and mouthfeel in dairy products such as yogurt. Dalboge does not disclose, teach, or suggest that hyaluronic acid could be added to a yogurt for the purpose of masking astringent taste in consumable that includes an astringency-imparting additive. A prima facie case for obviousness "requires a suggestion of all limitations in a claim," CFMT, Inc. v. Yield up Int'l. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) and "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR Jnt’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007)”.
In response to (a), (b) and (c), it is to be noted that
(a) Applicants argued about the substance of obviousness rejection based on the combined teaching of Sakamoto et al. in view of Joergensen and (alternatively) Dalboge et al. Examiner agrees with the applicant’s arguments that both the Joergensen, Dalboge are concerned with improved texture and mouthfeel in dairy products such as yogurt. They have similar motivation to modify Sakamoto et al. Therefore, Dalboge et al. has been considered as an alternative secondary prior art. However, Sakamoto et al. discloses hyaluronic acid or its salts in an amount of 0.1% by mass or less to provide taste masking effect in food including a beverage(s) (at least on page 4, fifth paragraph e.g. “masking effect is observed”). It is also to be noted that as because the disclosed hyaluronic acid and claimed hyaluronic acid are identical, therefore, the final product will have identical property including the property of “masking perceived astringency” also.
(b) Regarding the substance of the examiner’s obviousness rejection of the remarks as mentioned above, the requirements for obviousness are discussed in MPEP § 2142. As explained in the previous Office Action, Sakamoto et al. discloses hyaluronic acid or its salts provides taste masking effect when added to a beverage composition (at least on page 4, fifth paragraph e.g. “masking effect is observed” and at least on page 1, paragraph 9, 10). The only difference between claims 1, 15 and 18 and the teachings of Sakamoto et al. is the use of the claimed additive Hyaluronic acid and/or salt in ‘yogurt food’ composition. Joergensen et al. (and/ Dalboge et al.) teaches disclosed amount of hyaluronic acid (as additive) which meets claimed range amount and this range amount of hyaluronic acid and/or salt can be used in yogurt which improves texture and mouthfeel
(c ) In response to applicant's argument that Sakamoto et al. and Joergensen et al. is non-analogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both Sakamoto and Joergensen et al. (and/ Dalboge et al.) are directed to food composition using hyaluronic acid and/or salts.
In this instance, Sakamoto et al. is modified by including the teaching of Joergensen et al. who discloses that dairy products including yogurt can be made with the addition of hyaluronic acid salt and “the dairy product may include “plant protein’ also (Page 5, para 2 , page 3 para 10) because the yogurt containing hyaluronic acid/salt provides health benefits and also (page 2, and first few paragraphs) and sodium hyaluronate (i.e. salt) provides good texture and mouthfeel in yogurt product as disclosed by Dalbogne et al. (at least in Abstract, [0043] and [0070] e.g., Sodium hyaluronate, and claim 8 of Dalboge et al.). Therefore, the obviousness rejection is proper.
In regards to applicants allegation that the motivation provided for bringing in Joergensen and Dalboge would not apply to Sakamoto the examiner notes, and as discussed above, the motivation provided for bringing in Joergensen and Dalboge is to modify Sakamoto’s food product with the hyaluronic acid containing yogurt of Joergensen et al. because the yogurt containing hyaluronic acid/salt provides health benefits and also (page 2, and first few paragraphs) and sodium hyaluronate (i.e. salt) provides good texture and mouthfeel in yogurt product as disclosed by Dalbogne et al. (at least in Abstract, [0043] and [0070] e.g., Sodium hyaluronate, and claim 8 of Dalboge et al.). It is known that the disclosed hyaluronic acid/salt is identical to the claimed hyaluronic acid/salt and therefore, it would have identical claimed property of astringency-marking claimed property even if specific claimed property is not mentioned by the secondary prior arts of record. However, the rejection is proper with the disclosed motivation as provided for bringing in Joergensen and Dalboge which would apply to Sakamoto, Therefore, the rejection is made with proper motivation.
17. Regarding the amended claim 18, claim 18 recites “ astringent-masker consisting of”. it is to be noted that even if the amended claim 18 recites “close ended transitional phrase ‘consisting of” with respect to the astringent-masker hyaluronic acid, however, as discussed above, Sakamoto et al. discloses that a beverage(s) can be made by incorporating hyaluronic acid or its salts in an amount of 0.1% by mass or less to provide taste masking effect (at least on page 4, fifth paragraph e.g. “masking effect is observed”). Sakamoto et al. is primary prior art and Sakamoto teaches taste masking effect is provided only by hyaluronic acid (at least on page 1, last paragraph of Sakamoto et al.) which is superior to other agents including sweeteners which provides undesirable taste of their own when used higher amounts in beverage composition and this is agreed by the applicants also (in Remarks, page 2 first paragraph). Therefore, Sakamoto et al. is proper to address amended claim 18.
As such the rejection is maintained and is made as final.
Conclusion
18. 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 extension fee 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 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