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 11/12/2025, 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Any objections and/or rejections made in the previous action, and not repeated below, are hereby withdrawn.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 1-2, 4, 6, 8-15 are pending in this office action.
Independent claim 1 has been amended.
Claims 3, 5, 7 have been cancelled.
Claims 1-2, 4, 6, 8-15 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, 8-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Seko et al. JP 2007105018 A (Submitted by the applicant on 5/30/2025) in view of Wilke et al. (EP 0394731 A1).
8. Regarding claims 1, 2, 4, 6, 8- 9, 11, 13-15, Seko et al. discloses a thickening composition comprising high viscosity thickener comprising at least one selected from xanthan gum and/or high viscosity CMC (at least in [0030]) and low viscosity alginate which is used for adding to foods for a person who has difficulty in swallowing (Claims, [0001], [0014], [0024], [0029], [0033], [0061], and Examples). Seko et al. also discloses that the aqueous solution containing equal amounts of xanthan gum and low-viscosity alginate have lower viscosity than one containing xanthan gum alone (Table 1-2 [0043], Example 1 and claims 1, 2 of Seko et al.). Therefore, Seko et al. meet “improving swallowability for foods and drinks” as claimed in claims 1, 6.
Seko et al. also discloses that high viscosity CMC has viscosity 600 mPas , preferably 1000 mPa or more (at least in [0031]) and it is optimizable by modifying the molecular structure of CMC (at least in [0022]). Therefore, Seko et al. meets the amended claim limitation of “ “wherein CMC has a viscosity of at least 800 mPas measured at 2% at 25 degree C” as claimed in amended claim 1.
Absent showing of unexpected results, the specific amount of viscosity of second thickener ( i.e. High Viscosity CMC) is not considered to confer patentability to the claims. As the final consistency are variables that can be modified, among others, by modifying the molecular structure of second thickener CMC to the desired degree to achieve desired viscosity of the second thickener CMC , 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 desired modified molecular structure containing CMC (second thickener), in Seko et al. to amounts, including that presently claimed “at least 800 mPas, in order to obtain the desired effect e.g. desired viscosity containing CMC as second thickener in the 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).
It is also to be noted that this ‘eating disorder’ is known as dysphagia which meets claim 6.
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. also discloses many high viscosities thickening agent which can include xanthan gum, CMC, pectin etc. (at least in claim 2 of Seko et al.). Therefore, Pectin is optional.
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. It is to be noted that even if in example 1, [0043]) it recites 5 gm of Xanthan gum, however, this is an example. The disclosure by Seko et al. should be considered as a whole. Seko et al. also discloses that it is at least 5% by weight of xanthan gum and the range amount of high viscosity thickening agent e.g. xanthan gum (at least 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]). Therefore, the disclosed equal amounts of Xanthan gum and CMC has ratio 1 which is encompassed by the claimed ratio of 20/80 to 90/10 as claimed in claim 1 and also meet the range ratio 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).
It is also to be noted that the amounts and proportion of these two thickeners depend on type of fluid characteristics i.e. consistency etc. which is the characteristics property as claimed in claims 2, 4, 11 and can be made by optimizing the amounts and proportion of these two thickeners of the final product and discussed below.
In addition, as because Seko et al. used equal amounts in one example (Example 1) with low amount (5 gm) each thickener, therefore, examiner is not considering the ratio only based on one example of Seko having lower amount of thickener as an example only.
Examiner is considering secondary prior art by Wilke et al. also to address the ratio between two thickeners.
Wilke et al. discloses that cellulase free xanthan and Xanthan and cellulose derivatives are mixed ( 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) to meet amended independent claim 1, and 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).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Seko et al. with the teaching of Wilke et al. to consider Xanthan and cellulose derivative CMC in a mixing ratio of 1:4 to 4:1, preferably 1:2 to 2:1 (at least , under description, on page 3, third, 5th and last paragraph; at least in page 2, fourth paragraph) to be 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).
Therefore, Seko et al. in view of Wilke et al. disclose the ratio between Xanthan gum and CMC which is encompassed by the claimed ratio of 20/80 to 90/10 as claimed in claim 1 and also meet the range ratio 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).
It is also to be noted that the amounts and proportion of these two thickeners depend on type of fluid characteristics i.e. consistency etc. which is the characteristics property as claimed in claims 2, 4, 11 and can be made by optimizing the amounts and proportion of these two thickeners of the final product and discussed below. Therefore, Wilke et al. is relevant to be considered in this broad range ratio applicable for the broad range amounts of the thickeners.
9. 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 and high thickening CMC 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.
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, among others, by adjusting the amount of second thickener CMC into the first thickener (xanthan gum), 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 second thickener, in Seko 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 of the final thickener 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).
10. 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. 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).
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.
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 (at least in [0004]).
Response to arguments
13. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments overcome the rejections of record. However, the amended claim 1 can still be addressed using different embodiments from broadly disclosed Seko et al. as primary prior art and discussed below.
14. Arguments: Applicants argued on first page that “Claim 1 has been amended to recite: “carboxymethyl cellulose has a viscosity of at least 800 mPa-s measured at 2% at 25 °C”. Applicant notes Seko uses “low viscosity CMC” in combination with a high viscosity thickening agent, and the low viscosity CMC has a viscosity of 100 mPa:s or less measured at 10% CMC aqueous solution. (See Seko, paragraphs [0015] and [0020)]). It is thus clear that CMC used in the present invention has significantly higher viscosity than CMC used by Seko. Therefore, CMC recited in the amended claim | is substantially different from the low viscosity CMC taught by Seko”.
In response, it is to be noted that Primary prior art by Seko et al. broadly discloses high viscosity CMC with or without xanthan gum and in combination with low viscosity CMC or low viscosity sodium alginate (at least in claims 1, 2 of Seko et al. and Table 1-2 [0043], Example 1 of Seko et al.). Therefore, low viscosity CMC is optional and is not used in this office action. Therefore, the rejection of claim 1 is made using primary prior art by Seko et al. and addressing amended claim 1 with high viscosity CMC (at least in [0022], [0030], [0031], and claims 1, 2 of Seko et al.) having viscosity 600 mPas or more (at least in [0030], [0031]) and high viscosity CMC may be combined with high viscosity Xanthan also (at least in claims 1, 2 of Seko et al.).
Applicants do not have any further argument. Therefore, the rejection is made as final.
Conclusion
15. 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