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
Continued Examination under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/05/2026 has been entered.
Status of the application
3. Claims 1-2, 4, 6, 8-16 are pending in this office action.
Independent claim 1 has been amended.
Claims 3, 5, 7 were cancelled.
Claim 16 is new.
Claims 1-2, 4, 6, 8-16 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(a) 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 enquiries 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 nonobviousness.
7. Claims 1-2, 4,6, 8-16 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wilke et al. (EP 0394731 A1) in view of Seko et al. JP 2007105018 A (Submitted by the applicant on 5/30/2025).
8. Regarding claims 1, 13-16, Wilke et al. discloses that cellulase free xanthan and cellulose derivatives e.g. carboxy methyl cellulose (CMC) are mixed ( At least in Abstract, page 2 lines 5-12) are used in a mixing ratio of 1:4 to 4:1 preferably 1:2 to 2:1 (at least, under description, on page 3, third paragraph) and cellulose derivatives include CMC also (at least in page 2, fourth paragraph) and used in food composition (at least in page 4, paragraph 8, above Example 1) which provides surprisingly improved solubility and rheological property (at least Under Description, on page 3, fifth paragraph) and the disclosed thickener composition can be used in food, cosmetics and pharmaceuticals also ( at least page 4, 8 , above Examples). Therefore, it meets claim limitations of “ the first thickener” (i.e. Xanthan) and “the second thickener” ( CMC) and the mass ratio of xanthan gum to CMC is “from 20/80 to 90/10” as claimed in amended independent claim 1, and also the claimed range ratios as claimed in claims 13-15. 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).
Wilke et al. is specifically silent about “second thickener consists of CMC having a viscosity of at least 800 mPa.s. measured at 2% at 25 degree C” and also 800 mPa.s.to 16 00 mPa.s measured at 2% at 25 degree C” as claimed in new claim 16.
Seko et al. discloses that high viscosity CMC has viscosity 600 mPas, preferably ‘1000 mPa or more’ (at least in [0031]). Therefore, Seko et al. meets the amended claim limitation of "wherein CMC has a viscosity of at least 800 mPa.s measured at 2% at 25 degree C" as claimed in amended claim 1 and also 800 mPa.s.to 16 00 mPa.s measured at 2% at 25 degree C” as claimed in new claim 16.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).
It is to be noted that the temperature 25 degree C is room temperature. Therefore, it is interpreted as the disclosed “2% by weight”([0022]) without any specific temperature is interpreted as the viscosity measurement can be performed at room temperature.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Wilke et al. with the teaching of Seko et al. to consider high viscosity CMC in order to impart viscosity to diet meals, beverages, patients who have difficulty chewing or swallowing due to eating disorders and for use in food products to easily thicken sauces, soups, dressings, and other sauces (at least in [0001]).
Seko et al. also discloses that the viscosity of CMC with a concentration of 2% at 25 degree C can be adjusted by modifying the molecular structure of CMC in a wide range which overlaps claimed higher viscosity of at least 800 mPa.s. which is optimizable by modifying the molecular structure of CMC (Seko et a., at least in [0022]).
Therefore, it is within the skill of one of ordinary skill in the art to modify the molecular structure of CMC and to measure viscosity at 2% concentration as disclosed by Seko et al. ([0022]), in order to have desired concentration including desired high concentration of CMC greater than 800 mPa.s with a reasonable expectation of success to use it to make high viscosity “thickener” composition in order to impart viscosity to diet meals, beverages, patients who have difficulty chewing or swallowing due to eating disorders and for use in food products to easily thicken sauces, soups, dressings, and other sauces ( Seko et al., at least in [0001]).
It is to be noted that the claim limitation of “the second thickener consists of CMC having a viscosity of at least 800 mPa. s” as claimed in claim 1 , with specific close ended transitional phrase “consist of” can be interpreted as only CMC having viscosity with greater than 800 mPa.s is considered.
One of ordinary skill in the art would have been motivated to consider the thickener composition of Wilke et al. as modified by Seko et al. with high viscosity CMC in combination with xanthan gum with a reasonable expectation of success in order to serve broadly as thickener for various foods etc. and also an additional benefit for its specific use for the patients who have difficulty chewing or swallowing due to eating disorders (Seko et al. at least in [0001]) and the preparation is simple by stirring with hand (Seko et al. at least in [0003]). It is known that ‘dysphagia patient’ has difficulty chewing or swallowing due to eating disorders’ group of patients as well . Therefore, it meets “for ingestion aid for a person with dysphagia” as claimed in claim 6.
Therefore, Wilke et al. in view of Seko et al. meets this claim limitation with ‘consists of CMC having a viscosity of at least 800 mPa.s (i.e. close ended transitional phrase) containing amended independent claim 1.
Therefore, it is optimizable.
Absent showing of unexpected results, the specific amount of high viscosity CMC greater than 800 mPa. S for claim 1 (or 800 mPa.s -1600 mPa.s for claim 16) is not considered to confer patentability to the claims. As the viscosity of CMC is variable that can be modified, among others, by adjusting by modifying the molecular structure of CMC (Seko et al. [0022]), 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 viscosity 800-1600 mPa.s in Wilke et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired high viscosity CMC containing high viscosity thickener composition for its desired use (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 the claim limitation of “wherein the composition is free of pectin and alginate”, it is to be noted that primary prior art by Wilke et al. does not teach the use of pectin or alginate in Wilke’s composition. Seko et al. is secondary prior art and is used to teach specifically high viscosity CMC.
However, note that while Seko et al. do not disclose all the features of the present claimed invention, Seko et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, High viscosity CMC, and in combination with the primary reference, discloses the presently claimed invention.
9. Regarding claims 1, 2, 4 and 11, regarding the claim limitation of 'shear rate of first thickener from 1 to 100S-1' and "Newtonian viscosity at the shear rate from 1-100 S-1 of second thickener", as claimed in claim 1, it is to be noted that the first thickener is xanthan gum and second thickener is CMC is identical to the claimed xanthan gum and CMC having identical structure and the disclosed ratio meet the claimed ratio as discussed above, therefore, the disclosed thickener additive composition will have identical claimed property of 'shear rate of first thickener from 1 to 100S-1' and "Newtonian viscosity at the shear rate from 1-100 S-1 of second thickener" as claimed in independent claim 1 and also as claimed in claims 2, 4 and 11.
It is to be noted that the desired thickness can be manipulated by adjusting the ratio from the disclosed range amounts of xanthan gum and CMC and also by modifying the molecular structure of CMC (Seko et a., at least in [0022]). This desired consistency is the represented by non-Newtonian viscosity index (n), shear rate D and shear stress (P) as claimed in claims 2, 4, and 11 are the representation of the physical properties and the derivation of the equations for a specific range value of n and accordingly the value of P as claimed in claim 2, and claim 4 and also the ratio of c/b which is n at a certain range value of D as claimed in claim 11. Therefore, P, n and D are also optimizable.
Therefore, it is within the skill of one of ordinary skill in the art to optimize from within the disclosed range amounts and ratio of first and second thickeners which meet the claimed thickener in order to achieve the desired consistency of the final composition having desired property including the property to improve swallowability for foods and drinks as claimed in claimed invention. This desired consistency is the represented by non-Newtonian viscosity index (n), shear rate D and shear stress (P) as claimed in claims 2, 4, and 11 are the representation of the physical properties and the derivation of the equations for a specific range value of n and accordingly the value of P as claimed in claim 2, and claim 4 and also the ratio of c/b which is n at a certain range value of D as claimed in claim 11
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 n, D, and P in Seko et al. Margossian et al. in view of Wilke et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired property including
the property to improve swallowability for foods and drinks (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 claim 6, Wilke et al. discloses that the disclosed thickener composition can be used in food, cosmetics and pharmaceuticals also ( at least page 4, 8 , above Examples).
Seko et al. discloses that high viscosity CMC has viscosity 600 mPas, preferably ‘1000 mPa or more’ (at least in [0031]). Therefore, Seko et al. meets the amended claim limitation of "wherein CMC has a viscosity of at least 800 mPa.s as claimed in amended claim 1.
Therefore, one of ordinary skill in the art would have been motivated to consider the thickener composition of Wilke et al. as modified by Seko et al. with high viscosity CMC in combination with xanthan gum with a reasonable expectation of success in order to serve broadly as thickener for various foods etc. and also an additional benefit for its specific use for the patients who have difficulty chewing or swallowing due to eating disorders (Seko et al. at least in [0001]) and the preparation is simple by stirring with hand (Seko et al. at least in [0003]). It is known that ‘dysphagia patient’ has difficulty chewing or swallowing due to eating disorders’ group of patients as well . Therefore, it meets “for ingestion aid for a person with dysphagia” as claimed in claim 6.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Wilke et al. with the teaching of Seko et al. to consider high viscosity CMC in order to impart viscosity to diet meals, beverages, patients who have difficulty chewing or swallowing due to eating disorders and for use in food products to easily thicken sauces, soups, dressings, and other sauces (at least in [0001], [0003]).
11. Regarding claim 10, Wilke et al. discloses that the sum of the concentration of individual component can be from 0.25 to 1.5 wt.% and they can be xanthan and CMC (page 1, Under Description, first paragraph and page 4, paragraphs 2, 5). Therefore, it would have been obvious that this amount can be considered to be used in an aqueous liquid food including liquid beverages also. 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).
Furthermore, an optimization of the content of the thickeners is within the skill of a person skilled in the art could arrive in accordance with circumstances, and the advantageous effect of claim 10 is not considered to exceed what is predictable based on the state of the art.
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 thickener composition, in Margossian et al. in view of Wilke et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired consistency which improves swallowability for foods and drinks of the final food/liquid beverage composition (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 12, Seko et al. discloses that the final product can be made in granular form which provides the benefit of an improved dispersibility, and solubility , making it possible to disperse and dissolve them in water with almost no clumping (at least in [0004]).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Wilke et al. with the teaching of Seko et al. to make the final product can be made in granular form which provides the benefit of an improved dispersibility, and solubility , making it possible to disperse and dissolve them in water with almost no clumping (at least in [0004]).
13. Regarding claims 8, 9, it is to be noted that furthermore, an optimization of the content of the thickeners can be made from within the disclosed range amounts of high thickening agent which includes both combined Xanthan gum (i.e. claimed first thickener) and high thickening CMC (i.e. claimed second thickener) having total 5-30% by weight ([0033], claims 1, 2 of Seko et al.) and considering the ratio of Xanthan and cellulose derivative CMC in a mixing ratio of 1:4 to 4:1, preferably 1:2 to 2:1 as disclosed by Wilke et al. (at least , under description, on page 3, third, 5th and last paragraph; at least in page 2, fourth paragraph), it overlaps the claimed range amount of first (xanthan) and second (High thickening CMC) thickeners.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Wilke et al. with the teaching of Seko et al. to consider high viscosity CMC (i.e. claimed second thickener) at a desired amount by considering the disclosed combined amounts and proportions of of xanthan gum and CMC as discussed above, in order to impart desired viscosity to diet meals, beverages, patients who have difficulty chewing or swallowing due to eating disorders and for use in food products to easily thicken sauces, soups, dressings, and other sauces (at least in [0001]).
It is also to be noted that furthermore, an optimization of the content of the thickeners can be made from within the disclosed range amounts of high thickening agent which includes both combined Xanthan gum and high thickening CMC having total 5-30% by weight ([0033], claims 1, 2 of Seko et al.) which is merely a design matter which a person skilled in the art could arrive in accordance with circumstances, and the advantageous effect of claims 8-9 is not considered to exceed what is predictable based on the state of the art.
Absent showing of unexpected results, the specific amount of first thickener (xanthan gum) and second thickener (high viscosity CMC) is not considered to confer patentability to the claims. As the final consistency are variables that can be modified,
It is to be noted that Seko et al. also discloses that one or more high viscosities thickening agent which includes xanthan gum, and CMC can be used (at least in claim 2 of Seko et al.). to meet "wherein the first thickener is xanthan gum".
Seko et al. discloses that high viscosity thickening agent e.g. xanthan gum (e.g. xanthan gum in claim 1 of Seko et al.) can be in an amount of 5% or more and 30% by weight or less of the formulation (at least in [0033]). If we consider aqueous solution containing equal amounts of xanthan gum and low-viscosity alginate have lower viscosity than one containing xanthan gum alone ([0043], Example 1, [0033], Table 1-2 of Seko et al.), then CMC will be the same range amounts of 5-30% by weight in the formulation as disclosed for Xanthan gum. Therefore, it meets claim limitations of claims 8 and 9.
Response to arguments
14. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments overcome the rejections of record. However, after review, examiner noticed that Wilke et al. in view of Seko et al. can be used to address amended claim limitation including the claim limitation of “ consists of carboxymethylcellulose having a viscosity at least 800 mPa.s” in combination with “wherein the composition is free of pectin and alginate” as claimed in independent claim 1. The reason for considering the combinations of using Wilke et al. in view of Seko et al., using Seko et al. as secondary prior art is discussed below.
15. Seko et al. is used as secondary prior art to address claim limitation of “high viscosity CMC having a viscosity of at least 800 mPa.s” as claimed in claim 1 and also “viscosity of from 800 mPa.s to 1600 mPa.s” as claimed in claim 16 in the composition. The detailed are discussed in the office action above.
However, if we consider the disclosure of Seko et al . as a whole, Seko et al. is a broad disclosure.
Seko et al. discloses pectin as one of the thickening agents like CMC and xanthan gum ( at least in claim 2 of Seko et al.).
Seko et al. also discloses that if the viscosity is difficult to handle, it may be dispersed or dissolved in water or at least 10% low viscosity thickening agent for its use ( [0008]) and low viscosity thickening agent like alginate ([0014] ) may be used. Therefore, low viscosity thickening agent e.g. alginate is optional.
Seiko et al. also discloses the formulation with a high viscosity agent ([0001]) and it includes CMC with high viscosity having more than 600 mPa.s ([0031]). Therefore, more appropriately, Seko et al. is used as secondary prior art. As because Seko’s disclosure can be interpreted as pectin and alginate is optional, and also Seko et al. broadly discloses any viscosity (low and high) CMC, and high viscosity CMC (viscosity > 800 mPa.s) can be a preferred choice for specific purpose to impart viscosity to diet meals, beverages, patients who have difficulty chewing or swallowing due to eating disorders and for use in food products to easily thicken sauces, soups, dressings, and other sauces (at least in [0001]), therefore, Seko et al. is combinable to consider high viscosity CMC (viscosity > 800 mPa.s) with teaching suggestive motivation (TSM) to modify Wilke et al. to address amended independent claim 1 and new claim 16 in order to meet the presently claimed invention.
However, note that while Seko et al. do not disclose all the features of the present claimed invention, Seko et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely, High viscosity CMC, and in combination with the primary reference, discloses the presently claimed invention.
Conclusion
16. 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. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571 -272-1000.
/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights