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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/01/2026 has been entered.
Status of the application
3. Claims 1-7, 11, 12, 14-22 are pending in this office action.
Claims 1, 11, 12, 15 have been amended.
Claims 1-7, 11, 12, 14-22 are rejected.
Claim Rejections - 35 USC § 103
4. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
5. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
6. Claim(s) 1-6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Maria et al. (KR 2017/0057308 A) in view of Uzuhashi et al. USPN 6455090 and as evidenced by Hosomi et al. (JP 2007274927 A).
7. Regarding claims 1 -4, 16, Maria et al. discloses that dysphagia patients are treated using thickening agent comprising xanthan gum, acacia gum containing composition having at least 2 to 30 wt.% at least one thickener which can be used orally to treat dysphagia patient ( at least, page 3 paragraphs 2-7). Therefore, the combined range amount of xanthan gum and gum acacia meets the claimed range amounts of xanthan and Arabic gum (i.e. gum acacia) as claimed in claim 1 and also meet the claimed range amount of xanthan gum as claimed in claim 2 and also meet the claimed range amount of acacia gum as claimed in claim 3. 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 evidenced by Hosomi et al. that the gum arabic used in the field of food industry, for example, belong to Acacia Senegal (Acacia senegal) and Acacia Seiaru the (Acacia seyal) (page 5, second paragraph) as claimed in claims 1, 3, 4,16.
Regarding the amended claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 1, it is to be noted that we may interpret claim 1 as the thickening composition comprises xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5. Maria et al. discloses a broad range amounts of each thickener in the liquid thickener to serve as thickener and broadly discloses that the thickener can be an individual thickener alone or in combination (at least, page 3 paragraphs 2-7). It is to be noted that this claimed ratio can be performed using the broadly disclosed range amounts of individual xanthan gum and gum acacia as disclosed by Maria et al. (at least, page 3 paragraphs 2-7).
However, Maria et al. is specifically silent about both the xanthan and Arabic gum having the specific range amounts of each of them where xanthan range amount is lower than acacia gum having 6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum” which is interpreted as xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5 in the liquid thickener composition as claimed in claim 1.
Uzuhashi et al. discloses that the viscosity declines within the range of ratio of about xanthan :Arabic gum 5:10 (1:2) (5000 cp) to 5: 20 (1:4) (1800 cp) in presence of xanthan 5% concentration (at least in Fig 3).
Uzuhashi et al. discloses that one thickening agent xanthan gum as a liquid can be mixed with a low viscosity polysaccharide e.g. Arabic gum which provides the benefit of handling this mixed thickener liquid which has a low viscosity and excellent fluidity and can be easily treated even when they are dissolved in water at a high concentration ( col 4 lines 30-35 of Uzuhashi et al.).
Uzuhashi et al. also discloses that xanthan gum in the solution in presence of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to control viscosity caused by xanthan gum at a relatively high concentration which meets claimed range amount of “6% to 10% xanthan gum in the thickening composition.
Therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Maria et al. with the teaching of Uzuhashi et al. (at least in ( col 4 lines 26-35) to make thickener composition with desired higher concentration of xanthan gum and controlling viscosity (e.g. without having too high viscosity from xanthan gum) in presence of arabic gum in order to make the viscosity suitable for the intended use e.g. for the treatment of dysphagia patient.
It is also to be noted that the amended claim limitation of “the thickener composition can be used for the treatment of dysphagia in a subject in need thereof” as claimed in claim 1, it is considered as merely an intended use. Applicant’s attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Maria et al.in view of Uzuhashi et al. disclose use of xanthan and acacia gum, in combination, as presently claimed, it is clear that the thickener composition comprising Xanthan and acacia gum of Maria et al.in view of Uzuhashi et al. would be capable of performing the intended use, i.e. can be used for the treatment of dysphagia in a subject in need thereof” as presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
It is within the skill of one of ordinary skill in the art to optimize the amounts of the thickeners from within the disclosed range which will meet the claimed range amounts in order to achieve desired appropriate viscosity suitable for dysphagia patient.
This is optimizable. This is applicable for claim 1 and is applicable for the rejection of claims 11, 12, 15 which are rejected separately 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 xanthan and acacia gum in Maria et al. in view of Uzuhashi et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. thickening capacity with less amount of thickener composition because the thickener composition can contain proper amounts and ratio of xanthan gum and gum Arabic with desired viscosity containing thickener composition suitable for intended use e.g. for the treatment of dysphagia patient (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).
8. Regarding claims 5 and 6, Uzuhashi et al. discloses that pectin and calcium salt can be introduced into the thickener composition ( at least in col 7 lines 42-45) which provides the benefit to control viscosity further (at least in col 5 lines 50-54).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Maria et al. to include the teaching of Uzuhashi et al. in order to incorporate pectin is also added which makes an ionic bond with calcium or magnesium (col 5 lines 35-38 and col 7 lines 42-45) which provides the benefit to control viscosity further (col 5 lines 50-54).
9. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Maria et al. (KR 2017/0057308 A) in view of Uzuhashi et al. USPN 6455090 and further in view of Maria et al. (KR 2017/0057308 A) and as evidenced by Hosomi et al. (JP 2007274927 A) as applied to claim 1 and further in view of CUCA et al. AU 2860959 and further in view of Sworn US 2012/0021112 and (Additionally) in view of Goldy et al. AU 20040295003 A 1.
10. Regarding claim 7, Maria et al. in view of Uzuhashi et al. are silent about individual components as claimed in claim 7.
Cuca et al. discloses that an orally ingestible system (Abstract) comprising xanthan gum and gum acacia can include preservatives (benzoic acid and sorbic acid), buffer salt (e.g. citric acid-Sod citrate, acetic acid-sodium acetate etc.), antifoaming agent etc. (pages 16, last paragraph -page 17 first paragraph).
It is to be noted that even if Cuca’s additives are not specifically addressing thickener composition, however, it is related orally ingestible system comprising xanthan gum and gum acacia where the functionality of the individual components will remain identical as these are very close composition.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Maria et al. in view of Uzuhashi et al. with the teaching of Cuca et al. to include preservatives (benzoic acid and sorbic acid), buffer salt (e.g. citric acid-Sod citrate, acetic acid-sodium acetate etc.), antifoaming agent etc. (pages 16, last paragraph -page 17 first paragraph) in order to have their individual functionality in the final composition.
(Additionally), it is to be noted that and as disclosed by that preferred preservative can be in the form of benzoate and sorbate as disclosed by Goldy et al. (page 5 last paragraph).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Uzuhashi et al. to include the teaching of Goldy et al. (page 5 last paragraph) to include preservatives and that preferred preservative can be in the form of benzoate and sorbate as disclosed by Goldy et al. (page 5 last paragraph).
Maria et al. in view of Uzuhashi et al. are silent about “a food acid”.
Sworn et al. discloses that food acid citric acid is added to such Xanthan/Guar mixed system containing composition ([0112]) in order to adjust desired pH of the final product.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Maria et al. in view of Uzuhashi et al. to include the teaching of Sworn et al. to incorporate food acid citric acid is added to such Xanthan/Guar mixed system containing composition ([0112]) in order to adjust desired pH of the final product.
11. Claims 11, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Maria et al. (KR 2017/0057308 A) in view of Uzuhashi et al. USPN 6455090 and as evidenced by Hosomi et al. (JP 2007274927 A).
12. It is to be noted that claim 11 , and claims 17, 18 which depend on claim 11 are method claims. Uzuhashi et al. has disclosed the method steps to modify Maria et al. to meet claim 11 as discussed below. However, even if the identical combinations of prior arts used to reject claim 1 above, however, claim 11 is rejected separately as claim 11 is method claim.
13. Regarding claims 11, 17, 18,
It is evidenced by Hosomi that the gum arabic used in the field of food industry, for example, belong to Acacia Senegal (Acacia senegal) and Acacia Seiaru the (Acacia seyal) (Page 5, second paragraph). Therefore, it is known as Gum acacia also.
Regarding the claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 11, it is to be noted that we may interpret claim 1 as the thickening composition comprises xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5. Maria et al. discloses a broad range amounts of each thickener in the liquid thickener to serve as thickener and broadly discloses that the thickener can be an individual thickener alone or in combination (at least, page 3 paragraphs 2-7). It is to be noted that this claimed ratio can be performed using the broadly disclosed range amounts of individual xanthan gum and gum acacia as disclosed by Maria et al. (at least, page 3 paragraphs 2-7).
However, Maria et al. is specifically silent about both the xanthan and Arabic gum having the specific small range amounts of each of them and xanthan range amount is lower than acacia gum in the liquid thickener composition as claimed in claim 11.
Regarding the claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 11, it is to be noted that we may interpret claim 11 as the thickening composition comprises xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5.
Maria et al. is specifically silent about (a) the steps of claim 11 and also (b) silent about the range amount of xanthan is lower than acacia gum in the liquid thickener composition having 6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum” in a ratio of about 1:2.5 to 1:3.5 as claimed in claim 11.
With respect to (a), Uzuhashi et al. discloses a method of making thickener composition by combining that Arabic gum can be dissolved in water ( col 4 lines 65-67) to meet “providing a liquid composition comprising gum acacia” as claimed in claim 11.
Uzuhashi et al. also discloses xanthan gum can be mixed with a low viscosity polysaccharide e.g. Arabic gum in solution (col 4 lines 65-67 and col 5 lines 1-7) which provides the benefit of handling this mixed thickener liquid which has a low viscosity and excellent fluidity and can be easily treated even when they are dissolved in water at a high concentration ( col 4 lines 30-35 of Uzuhashi et al.). Uzuhashi et al. also discloses that xanthan gum in the solution of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to reduce viscosity of xanthan gum when xanthan gum has relatively high concentration in the thickening composition.
Therefore, Maria et al. in view of Uzuhashi et al. meet the claim limitation of “adding a composition comprising xanthan gum to provide the liquid thickener composition” of claim 11.
With respect to (b), regarding the amended claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 11, it is to be noted that Uzuhashi et al. also discloses that xanthan gum in the solution in presence of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to control viscosity caused by xanthan gum at a relatively high concentration which meets claimed range amount of “6% to 10% xanthan gum in the thickening composition.
Uzuhashi et al. discloses that the viscosity declines within the range of ratio of about xanthan :Arabic gum 5:10 (1:2) (5000 cp) to 5: 20 (1:4) (1800 cp) in presence of xanthan 5% concentration (at least in Fig 3 and col 5 lines 5-7).
It is within the skill of one of ordinary skill in the art to optimize the amounts of the thickeners from within the disclosed range which will meet the claimed range amounts in order to achieve desired appropriate viscosity suitable for dysphagia patient.
Therefore, one of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Maria et al. with the teaching of Uzuhashi et al. (at least in ( col 4 lines 26-35) to make thickener composition with desired higher concentration of xanthan gum and controlling viscosity (e.g. without having too high viscosity from xanthan gum) in presence of arabic gum in order to make the viscosity suitable for the intended use e.g. for the treatment of dysphagia patient.
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 xanthan and acacia gum in Maria et al. in view of Uzuhashi et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. thickening capacity with less amount of thickener composition because the thickener composition can contain proper amounts and ratio of xanthan gum and gum Arabic with desired viscosity containing thickener composition suitable for intended use e.g. for the treatment of dysphagia patient (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 the amended claim limitation of “the thickener composition can be used for the treatment of dysphagia in a subject in need thereof” as claimed in claim 1, it is considered as merely an intended use. Applicant’s attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Maria et al.in view of Uzuhashi et al. disclose use of xanthan and acacia gum, in combination, as presently claimed, it is clear that the thickener composition comprising Xanthan and acacia gum of Maria et al.in view of Uzuhashi et al. would be capable of performing the intended use, i.e. can be used for the treatment of dysphagia in a subject in need thereof” as presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
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 the thickeners Xanthan gum and acacia gum in Maria et al.in view of Uzuhashi et al. and Maria et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired viscosity ideal viscosity for ingestion by the dysphagia patient (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 steps of providing and mixing the reconstituted liquid thickener of claim 11, it is to be noted that if we consider the disclosure by Uzuhashi et al., who discloses in one example that 85 parts of gum acacia is dissolved in water followed by mixing xanthan in water and this is added to the gum Arabic solution (col 4 lines 65-67 and col 5 lines 1-8) and this is considered as “resultant thickening agent” which , can be added to be further dissolve into large desired amount of water , the resultant mixture immediately form viscous solution having desired viscosity (col 5 lines 12-14).
Therefore, it meets the step of providing and mixing (to dissolve) “said liquid thickener composition containing xanthan plus gum Arabic in water (i.e. ‘a liquid’ ) as claimed in claim 11 liquid to make viscous solution which provides desired “liquid thickened composition of third step of claim 11 having desired viscosity (i.e. cP) value.
14. Claims 12, 19, 20 are rejected under 35 U.S.C. 103 as being unpatentable over Maria et al. (KR 2017/0057308 A) in view of Uzuhashi et al. USPN 6455090 in view of Miyakawa et al. US 2014/0332736 A1 and as evidenced by Hosomi et al. (JP 2007274927 A).
15. Regarding claims 12, 19, 20, it is to be noted that claim 12 , and claims 19, 20 which depend on claim 12 are method claims. Uzuhashi et al. has disclosed the method steps to modify Maria et al. to meet claim 12 as discussed below. However, even if the identical combinations of prior arts used to reject claim 1 above, however, claim 12 is rejected separately as claim 12 is method claim.
16. Regarding claims 12, 19, 20, Maria et al. discloses that dysphagia patients are treated using thickening agent comprising xanthan gum, acacia gum containing composition having at least 2 to 30 wt.% at least one thickener which can be used orally to treat dysphagia patient ( at least, page 3 paragraphs 2-7). Therefore, the combined range amount of xanthan gum and gum acacia meets the claimed range amounts of xanthan and Arabic gum (i.e. gum acacia) as claimed in claim 12 and also meet the claimed range amount of xanthan gum as claimed in claim 19 and also meet the claimed range amount of acacia gum as claimed in claim 20. 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 evidenced by Hosomi et al. that the gum arabic used in the field of food industry, for example, belong to Acacia Senegal (Acacia senegal) and Acacia Seiaru the (Acacia seyal) (page 5, second paragraph) as claimed in claims 12,19.
It is evidenced by Hosomi that the gum arabic used in the field of food industry, for example, belong to Acacia Senegal (Acacia senegal) and Acacia Seiaru the (Acacia seyal) (Page 5, second paragraph). Therefore, it is known as Gum acacia also.
Regarding the claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 12, it is to be noted that we may interpret claim 12 as the thickening composition comprises xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5. Maria et al. discloses a broad range amounts of each thickener in the liquid thickener to serve as thickener and broadly discloses that the thickener can be an individual thickener alone or in combination (at least, page 3 paragraphs 2-7). It is to be noted that this claimed ratio can be performed using the broadly disclosed range amounts of individual xanthan gum and gum acacia as disclosed by Maria et al. (at least, page 3 paragraphs 2-7).
However, Maria et al. is specifically silent about both the xanthan and Arabic gum having the specific small range amounts of each of them and xanthan range amount is lower than acacia gum in the liquid thickener composition as claimed in claim 11.
Regarding the claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 12, it is to be noted that we may interpret claim 11 as the thickening composition comprises xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5.
Maria et al. is specifically silent about (a) the steps of claim 12 and also (b) silent about the range amount of xanthan is lower than acacia gum in the liquid thickener composition having 6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum” in a ratio of about 1:2.5 to 1:3.5 as claimed in claim 12.
With respect to (a), Uzuhashi et al. discloses a method of making thickener composition by combining that Arabic gum can be dissolved in water ( col 4 lines 65-67) to meet “providing a liquid composition comprising gum acacia” as claimed in claim 12.
Uzuhashi et al. also discloses xanthan gum can be mixed with a low viscosity polysaccharide e.g. Arabic gum in solution (col 4 lines 65-67 and col 5 lines 1-7) which provides the benefit of handling this mixed thickener liquid which has a low viscosity and excellent fluidity and can be easily treated even when they are dissolved in water at a high concentration ( col 4 lines 30-35 of Uzuhashi et al.). Uzuhashi et al. also discloses that xanthan gum in the solution of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to reduce viscosity of xanthan gum when xanthan gum has relatively high concentration in the thickening composition.
Therefore, Maria et al. in view of Uzuhashi et al. meet the claim limitation of “adding a composition comprising xanthan gum to provide the liquid thickener composition” of claim 12.
With respect to (b), regarding the amended claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 12, it is to be noted that we need to consider the disclosure by Maria et al. in combination with Uzuhashi et al.
Uzuhashi et al. also discloses that xanthan gum in the solution in presence of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to control viscosity caused by xanthan gum at a relatively high concentration which meets claimed range amount of “6% to 10% xanthan gum in the thickening composition.
Uzuhashi et al. discloses that the viscosity declines within the range of ratio of about xanthan :Arabic gum 5:10 (1:2) (5000 cp) to 5: 20 (1:4) (1800 cp) in presence of xanthan 5% concentration (at least in Fig 3 and col 5 lines 5-7).
With respect to (b), regarding the amended claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 12, it is to be noted that we need to consider the disclosure by Maria et al. in combination with Uzuhashi et al.
Uzuhashi et al. also discloses that xanthan gum in the solution in presence of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to control viscosity caused by xanthan gum at a relatively high concentration which meets claimed range amount of “6% to 10% xanthan gum in the thickening composition.
Uzuhashi et al. discloses that the viscosity declines within the range of ratio of about xanthan :Arabic gum 5:10 (1:2) (5000 cp) to 5: 20 (1:4) (1800 cp) in presence of xanthan 5% concentration (at least in Fig 3 and col 5 lines 5-7).
It is within the skill of one of ordinary skill in the art to optimize the amounts of the thickeners from within the disclosed range which will meet the claimed range amounts in order to achieve desired appropriate viscosity suitable for dysphagia patient.
Therefore, one of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify Maria et al. with the teaching of Uzuhashi et al. (at least in ( col 4 lines 26-35) to make thickener composition with desired higher concentration of xanthan gum and controlling viscosity (e.g. without having too high viscosity from xanthan gum) in presence of arabic gum in order to make the viscosity suitable for the intended use e.g. for the treatment of dysphagia patient.
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 xanthan and acacia gum in Maria et al. in view of Uzuhashi et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. thickening capacity with less amount of thickener composition because the thickener composition can contain proper amounts and ratio of xanthan gum and gum Arabic with desired viscosity containing thickener composition suitable for intended use e.g. for the treatment of dysphagia patient (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 the amended claim limitation of “the thickener composition can be used for the treatment of dysphagia in a subject in need thereof” as claimed in claim 1, it is considered as merely an intended use. Applicant’s attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Maria et al.in view of Uzuhashi et al. disclose use of xanthan and acacia gum, in combination, as presently claimed, it is clear that the thickener composition comprising Xanthan and acacia gum of Maria et al.in view of Uzuhashi et al. would be capable of performing the intended use, i.e. can be used for the treatment of dysphagia in a subject in need thereof” as presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
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 the thickeners Xanthan gum and acacia gum in Maria et al.in view of Uzuhashi et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired viscosity ideal viscosity for ingestion by the dysphagia patient (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 step of providing and adding the reconstituted liquid thickener , if we consider the disclosure by Uzuhashi et al., who discloses in one example that 85 parts of gum acacia is dissolved in water followed by mixing xanthan in water and this is added to the gum Arabic solution (col 4 lines 65-67 and col 5 lines 1-8) and this is considered as “resultant thickening agent” which , can be added to be further dissolve into large desired amount of water , the resultant mixture immediately form viscous solution having desired viscosity (col 5 lines 12-14). Therefore, it meets the step of adding and dissolving “said liquid thickener composition containing xanthan plus gum Arabic in water (i.e. ‘a liquid’ as claimed in claim 11) liquid to make viscous solution which provides desired “liquid thickened composition of third step of claim 12 having desired viscosity (i.e. cP) value.
However, Maria et al. in view of Uzuhashi et al. is silent about the step of ‘degassing’ as claimed in claim 12 (d).
Miyakawa et al. discloses that a composition comprising thickener, preservative, viscosity stabilizer (i.e. viscosity causing composition) can include degasser/anti-foamer also (at least in [0119]). The disclosure of Miyakawa et al. can be interpreted as degassing causes no foaming /minimal foaming of the composition when used for intended purpose. It is also to be noted that and it is known that degassing provides product stability and protection from unwanted oxidation when the product comprises oxygen sensitive material.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Uzuhashi et al. with the teaching of Miyakawa et al. to include degassing step which will eliminate air or gas which to avoid further foaming during its use and also it is known that degassing provides product stability and protection from unwanted oxidation when the product comprises oxygen sensitive material.
17. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over unpatentable over Maria et al. ( KR 20170057308 A) in view of Uzuhashi et al. USPN 6455090 in view of Miyakawa et al. US 2014/0332736 A1 and as evidenced by Hosomi et al. JP 2007274927 A as applied to claim 12 and further in view of CUCA et al. AU 2860959 and further in view of Sworn US 2012/0021112 and (Additionally) in view of Goldy et al. AU 20040295003 A 1.
18. Regarding claim 14, it is evidenced by Hosomi et al. that the gum arabic used in the field of food industry, for example, belong to Acacia Senegal (Acacia senegal) and Acacia Seiaru the (Acacia seyal) (Page 5 seconf paragraph). Therefore, it is known as Gum acacia also.
Maria et al. in view of Uzuhashi et al. are silent about individual components as claimed in claim 14.
Cuca et al. discloses that an orally ingestible system (Abstract) comprising xanthan gum and gum acacia can include preservatives (benzoic acid and sorbic acid), buffer salt (e.g. citric acid-Sod citrate, acetic acid-sodium acetate etc.), antifoaming agent etc. (pages 16, last paragraph -page 17 first paragraph).
It is to be noted that even if Cuca’s additives are not specifically addressing thickener composition, however, it is related orally ingestible system comprising xanthan gum and gum acacia where the functionality of the individual components will remain identical as these are very close composition.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Uzuhashi et al. with the teaching of Cuca et al. to include preservatives (benzoic acid and sorbic acid), buffer salt (e.g. citric acid-Sod citrate, acetic acid-sodium acetate etc.), antifoaming agent etc. (pages 16, last paragraph -page 17 first paragraph) in order to have their individual functionality in the final composition.
(Additionally), it is to be noted that and as disclosed by that preferred preservative can be in the form of benzoate and sorbate as disclosed by Goldy et al. (page 5 last paragraph).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Ushashi et al. to include the teaching of Goldy et al. (page 5 last paragraph) to include preservatives and that preferred preservative can be in the form of benzoate and sorbate as disclosed by Goldy et al. (page 5 last paragraph).
Sworn et al. discloses that food acid citric acid is added to such Xanthan/Guar mixed system containing composition ([0112]) in order to adjust desired pH of the final product.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Uzuhashi et al. to include the teaching of Sworn et al. to incorporate food acid citric acid is added to such Xanthan/Guar mixed system containing composition ([0112]) in order to adjust desired pH of the final product.
Regarding the claim limitation “and adding to a composition comprising acacia gum, it is to be noted that Uzuhashi et al. discloses that adding to “the liquid thickener composition” can read on “adding to a composition comprising acacia gum”. Therefore, modified Uzuhashi et al. as modified by Cuca et al., Golgy et al. and Sworn et al. can meet the claim limitation of claim 14.
19. Claims 15, 21, 22 are rejected under 35 U.S.C. 103 as being unpatentable over Maria et al. ( KR 20170057308 A) in view of Uzuhashi et al. USPN 6455090 and further in view of CUCA et al. AU 2860959 and further in view of Sworn US 2012/0021112 and (Additionally) and as evidenced by Hosomi et al. JP 2007274927 A
20. Regarding claims 15, 21, 22, it is to be noted that claims 21, 22 which depend on claim 15 are method claims. Uzuhashi et al. has disclosed the method steps to modify Maria et al. to meet claim 12 as discussed below. However, even if the identical combinations of prior arts used to reject claim 1 above, however, claim 15 is rejected separately as claim 15 is method claim.
21. Regarding claims 15, 21, 22, Maria et al. discloses that dysphagia patients are treated using thickening agent comprising xanthan gum, acacia gum containing composition having at least 2 to 30 wt.% at least one thickener which can be used orally to treat dysphagia patient ( at least, page 3 paragraphs 2-7). Therefore, the combined range amount of xanthan gum and gum acacia meets the claimed range amounts of xanthan and Arabic gum (i.e. gum acacia) as claimed in claim 15 and also meet the claimed range amount of xanthan gum as claimed in claim 21 and also meet the claimed range amount of acacia gum as claimed in claim 22. 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 evidenced by Hosomi et al. that the gum arabic used in the field of food industry, for example, belong to Acacia Senegal (Acacia senegal) and Acacia Seiaru the (Acacia seyal) (page 5, second paragraph) as claimed in claims 15, 21.
It is evidenced by Hosomi that the gum arabic used in the field of food industry, for example, belong to Acacia Senegal (Acacia senegal) and Acacia Seiaru the (Acacia seyal) (Page 5, second paragraph). Therefore, it is known as Gum acacia also.
Regarding the claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 11, it is to be noted that we may interpret claim 1 as the thickening composition comprises xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5. Maria et al. discloses a broad range amounts of each thickener in the liquid thickener to serve as thickener and broadly discloses that the thickener can be an individual thickener alone or in combination (at least, page 3 paragraphs 2-7). It is to be noted that this claimed ratio can be performed using the broadly disclosed range amounts of individual xanthan gum and gum acacia as disclosed by Maria et al. (at least, page 3 paragraphs 2-7).
However, Maria et al. is specifically silent about both the xanthan and Arabic gum having the specific small range amounts of each of them and xanthan range amount is lower than acacia gum in the liquid thickener composition as claimed in claim 15.
Regarding the claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 15, it is to be noted that we may interpret claim 15 as the thickening composition comprises xanthan and acacia gum in a ratio of about 1:2.5 to 1:3.5.
Maria et al. is specifically silent about (a) the steps of claim 11 and also (b) silent about the range amount of xanthan is lower than acacia gum in the liquid thickener composition having 6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum” in a ratio of about 1:2.5 to 1:3.5 as claimed in claim 15.
With respect to (a), Uzuhashi et al. discloses a method of making thickener composition by combining that Arabic gum can be dissolved in water ( col 4 lines 65-67) to meet “providing a liquid composition comprising gum acacia” as claimed in claim 15.
Uzuhashi et al. also discloses xanthan gum can be mixed with a low viscosity polysaccharide e.g. Arabic gum in solution (col 4 lines 65-67 and col 5 lines 1-7) which provides the benefit of handling this mixed thickener liquid which has a low viscosity and excellent fluidity and can be easily treated even when they are dissolved in water at a high concentration ( col 4 lines 30-35 of Uzuhashi et al.). Uzuhashi et al. also discloses that xanthan gum in the solution of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to reduce viscosity of xanthan gum when xanthan gum has relatively high concentration in the thickening composition.
Therefore, Maria et al. in view of Uzuhashi et al. meet the claim limitation of “adding a composition comprising xanthan gum to provide the liquid thickener composition” of claim 15.
With respect to (b), regarding the amended claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 12, it is to be noted that we need to consider the disclosure by Maria et al. in combination with Uzuhashi et al.
Uzuhashi et al. also discloses that xanthan gum in the solution in presence of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to control viscosity caused by xanthan gum at a relatively high concentration which meets claimed range amount of “6% to 10% xanthan gum in the thickening composition.
Uzuhashi et al. discloses that the viscosity declines within the range of ratio of about xanthan :Arabic gum 5:10 (1:2) (5000 cp) to 5: 20 (1:4) (1800 cp) in presence of xanthan 5% concentration (at least in Fig 3 and col 5 lines 5-7).
With respect to (b), regarding the amended claim limitation of “6%-10% by weight of xanthan gum” and 15-20% by weight of acacia gum”, as claimed in claim 15, it is to be noted that we need to consider the disclosure by Maria et al. in combination with Uzuhashi et al.
Uzuhashi et al. also discloses that xanthan gum in the solution in presence of Arabic gum has lower viscosity than that of the liquid thickening of xanthan gum only with water (col 5 lines 5-7, 20-25). It is, therefore, more effective to combine Arabic gum to control viscosity caused by xanthan gum at a relatively high concentration which meets claimed range amount of “6% to 10% xanthan gum in the thickening composition.
Uzuhashi et al. discloses that the viscosity declines within the range of ratio of about xanthan :Arabic gum 5:10 (1:2) (5000 cp) to 5: 20 (1:4) (1800 cp) in presence of xanthan 5% concentration (at least in Fig 3 and col 5 lines 5-7).
It is within the skill of one of ordinary skill in the art to optimize the amounts of the thickeners from within the disclosed range which will meet the claimed range amounts in order to achieve desired appropriate viscosity suitable for dysphagia patient.
Therefore, one of ordinary skill in the art before the effective filling date of the
claimed invention would have been motivated to modify Maria et al. with the teaching of Uzuhashi et al. (at least in ( col 4 lines 26-35) to make thickener composition with desired higher concentration of xanthan gum and controlling viscosity (e.g. without having too high viscosity from xanthan gum) in presence of arabic gum in order to make the viscosity suitable for the intended use e.g. for the treatment of dysphagia patient.
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 xanthan and acacia gum in Maria et al. in view of Uzuhashi et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. thickening capacity with less amount of thickener composition because the thickener composition can contain proper amounts and ratio of xanthan gum and gum Arabic with desired viscosity containing thickener composition suitable for intended use e.g. for the treatment of dysphagia patient (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 the amended claim limitation of “the thickener composition can be used for the treatment of dysphagia in a subject in need thereof” as claimed in claim 1, it is considered as merely an intended use. Applicant’s attention is drawn to MPEP 2111.02 which states that intended use statements must be evaluated to determine whether the intended use results in a structural difference between the claimed invention and the prior art. Only if such structural difference exists, does the recitation serve to limit the claim. If the prior art structure is capable of performing the intended use, then it meets the claim.
It is the examiner’s position that the intended use recited in the present claims does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure is capable of performing the intended use. Given that Maria et al.in view of Uzuhashi et al. disclose use of xanthan and acacia gum, in combination, as presently claimed, it is clear that the thickener composition comprising Xanthan and acacia gum of Maria et al.in view of Uzuhashi et al. would be capable of performing the intended use, i.e. can be used for the treatment of dysphagia in a subject in need thereof” as presently claimed as required in the above cited portion of the MPEP, and thus, one of ordinary skill in the art would have arrived at the claimed invention.
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 the thickeners Xanthan gum and acacia gum in Maria et al.in view of Uzuhashi et al. and Maria et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired viscosity ideal viscosity for ingestion by the dysphagia patient (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 step of providing and adding the reconstituted liquid thickener , if we consider the disclosure by Uzuhashi et al., who discloses in one example that 85 parts of gum acacia is dissolved in water followed by mixing xanthan in water and this is added to the gum Arabic solution (col 4 lines 65-67 and col 5 lines 1-8) and this is considered as “resultant thickening agent” which , can be added to be further dissolve into large desired amount of water , the resultant mixture immediately form viscous solution having desired viscosity (col 5 lines 12-14). Therefore, it meets the step of adding and dissolving “said liquid thickener composition containing xanthan plus gum Arabic in water (i.e. ‘a liquid’ as claimed in claim 11) liquid to make viscous solution which provides desired “liquid thickened composition of third step of claim 12 having desired viscosity (i.e. cP) value.
However, Maria et al. does not teach claimed pH.
Sworn et al. discloses that food acid citric acid is added to such Xanthan/Guar mixed system containing composition ([0112]) in order to adjust desired pH of the final product. Sworn et al. also discloses that the pH can broadly range from acidic to neutral d slightly basic (pH 8.0) depending on the field of use, e.g. for food product, it can be at higher end, therefore, depending on type of food, it would have been obvious preferred acidic range including claim limitation of pH 3.0-4.5 as claimed in claim 15. This is variable and optimizable.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Maria et al. in view of Uzuhashi et al. to include the teaching of Sworn et al. to incorporate food acid citric acid is added to such Xanthan/Guar mixed system containing composition ([0112]) in order to adjust desired pH of the final product.
Absent showing of unexpected results, the specific pH range value is not considered to confer patentability to the claims. As the taste, texture are variables depending on the type of food (e.g. acidic beverage, neutral pH food etc.) that can be modified, among others, by adjusting the pH, 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 pH range value in Uzuhashi et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. taste, texture etc. for specific type of food. (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).
22. Regarding the claim limitation of “preparing the acacia gum premix by dry- mixing”, it is to be noted that the method of claim 15 differs from Maria et al. in view of Uzuhashi et al. in that the liquid composition comprising the acacia gum (in Uzuhashi et al., at least in col 4 lines 65-67 and col 5 lines 1-5) also comprises a buffering salt and that the pH is adjusted to between 3.0 to 4.5.
In the absence of any demonstrated technical effect related to adding a buffering salt and/ or adjusting the pH to between 3.0 and 4.5, the problem to be solved can at most be formulated as the provision of an alternative method for producing a liquid thickener composition.
It is to be noted that said features are merely straightforward possibilities which the skilled person would select, without exercising inventive skill, when wanting to provide an alternative method for producing a liquid thickener composition. Consequently, claim 15 is obvious over Maria et al. in view of Uzuhashi et al.
disclose that similar additives e.g. salts of food acids etc. can be in powder form (claims 1, 6). Uzuhashi et al. discloses that dry gum Arabic (gum acacia) is dissolved in water (at least in col 4 lines 65-67 and col 5 lines 1-5).
However, more specifically, Maria et al. in view of Uzuhashi et al. are silent about “buffering salt.”
Cuca et al. discloses that an orally ingestible system (Abstract) comprising xanthan gum and gum acacia can include preservatives (benzoic acid and sorbic acid), buffer salt (e.g. citric acid-Sod citrate, acetic acid-sodium acetate etc.), antifoaming agent etc. (pages 16, last paragraph -page 17 first paragraph).
It is to be noted that even if Cuca’s additives are not specifically addressing thickener composition, however, it is related orally ingestible system comprising xanthan gum and gum acacia where the functionality of the individual components will remain identical as these are very close composition.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Maria et al. in view of Uzuhashi et al. with the teaching of Cuca et al. to include preservatives (benzoic acid and sorbic acid), buffer salt (e.g. citric acid-Sod citrate, acetic acid-sodium acetate etc.), antifoaming agent etc. (pages 16, last paragraph -page 17 first paragraph) in order to have their individual functionality in the final composition.
It is to be noted that Maria et al. in view of Uzuhashi et al. as modified by Cuca et al., and Sworn et al. disclose adding the ingredients in dry gum acacia and then dissolving with the water. However, Maria et al. in view of Uzuhashi et al. teach substantially the same product produced by substantially the same method as instantly claimed by applicant; where the claimed and prior art products are produced by substantially identical processes, a prima facie case of obviousness has been established. To switch the order of performing process steps, i.e. the order of the addition of the ingredients into the final mixture, would be obvious absent any clear and convincing evidence and/or arguments to the contrary (MPEP 2144.04 [R-1]). “Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results". Therefore, absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to add the salt to the wheat flour and the rice flour before adding the hot water.
Response to arguments
23. Applicant’s arguments and amendments have been considered. Applicant’s arguments and amendments overcome the rejections of record. It is to be noted that the amended claim limitation of “for treatment dysphagia patient” is an intended use. However, e examiner has used a new primary prior art by Maria et al. (111 KR 20170057308 A) to address amended claim limitations of claims 1,11,12, 15. Examiner has not considered prior primary prior art by Woo et al.. Therefore, the arguments made for Woo et al. is considered as moot.
24. Applicants argued in remarks, on third page, last but one paragraph that “None of the cited references provide such a motivation. Therefore, the "slight" difference rationale of the cited case law in In re Woodruff and Titanium Metals Corp. of America v. Banner does not apply at least because Uzuhashi provides not one but two ranges that differ from the present claims.
In response, it is to be noted that Uzuhashi et al.is secondary prior art. Uzuhashi et al. discloses with motivation the rationale of having combinations of xanthan and of Arabic gum as thickener in thickening composition as claimed in independent claims 1, 11, 12, 15.
It is also to be noted that Uzuhashi et al. discloses, in an example, 10 parts of gum Arabic and 5 parts of xanthan gum are used together provides reduction of viscosity of xanthan gum in presence of gum Arabic and it is more when xanthan gum is added in water only without gum Arabic (col 4 last paragraph to col 5 lines 5-7, 20-25). Therefore, the combinations can consider higher concentration of xanthan gum with gum Arabic in the thickener composition. However, if we consider the disclosure as a whole, Uzuhashi et al. discloses in Fig 3 that the viscosity decline is within the range of ratio of about xanthan :Arabic gum 5:10 (1:2) (5000 cp) to 5: 20 (1:4) (1800 cp) from original 9000 cp when Arabic gum is zero % conc. Therefore, the amount of xanthan gum in Uzuhashi et al. is just an example to establish the relationship between xanthan and Arabic gum as is demonstrated in Fig 3, of Uzuhashi et al. Therefore, one of ordinary skill in the art can use this teaching of Uzuhashi et al.to increase the amount of higher concentration of xanthan without increasing the viscosity which is balanced by lowering proportionate amount of Arabic gum (Fig 3 of Uzuhashi et al.) which can help to make higher xanthan gum containing thickener composition for its broader choice of use to reach desired concentration without the increased volume of the liquid thickener in the final composition. This is optimizable and discussed in the office action above
Unexpected Result:
25. Applicants argued in remarks, on Fourth page that “New and unexpected results are provided by the present claims as detailed in the experimental data set forth in the Examples of the specification (For example, Examples 6 and 7) and also paragraph [0350] of the published application establishes the criticality of the claimed range for acacia gum”.
In response, examiner has considered the complete arguments presented on Fourth page, under this section and is responding below:
Regarding Unexpected result, the examiner acknowledges the arguments in this respect. However, the arguments are insufficient to overcome the above rejection because
(1) Applicant’s has not compared the claimed invention to the teachings of the closest prior art reference by Uzuhashi et al. In this instance, applicants should consider Uzuhashi et al. as the closest prior art to establish that the disclosed ratio is not applicable other than 5% xanthan gum (i.e. claimed 6-10% xanthan gum) with proportionate amount of Arabic gum as disclosed at least in Fig 3 of Uzuhashi et al.
(2) Evidence of unexpected results must be commensurate in scope with the subject matter claimed. In re Linder 173 USPQ 356. More importantly, the evidence of unexpected results should commensurate with the scope of the claims and it 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.
To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside (i.e. as well as the upper and lower limits) the claimed range to show the criticality of the claimed range. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02.
In this instance, applicants could not establish unexpected result. The reason is if we consider examples 6, 7, it is to be noted that applicants considered varying amounts of gum Arabic for the optimization of gum Arabic concentration with 8% Xanthan gum (only one value).
Applicant’s has demonstrated that in Example 6, group numbers 3, 4 having 25% and 30% Gum Arabic respectively and for example 7, group number 1, it is 13.5% gum Arabic which are outside the claimed range of 15 to about 20%. No phase separation was noticed in any of the samples including group numbers 3, 4 of example 6 and group number 1 of example 1 after two days (at least in PGPUB [0337], [0344]).
However, applicant’s presented the result using only 8% xanthan gum (in Examples 6,7). Applicant’s mentioned that this 8% higher concentration of Xanthan gum does not provide any phase separation. However, claims 1,11, 12, 15 claims higher limit of 10% by weight xanthan gum. Therefore, applicant’s should provide results of using at least 10% xanthan gum that this claimed higher limit does not provide any phase separation effect and also if 11%, it may cause phase separation in order to establish the criticality of the higher limit of xanthan gum at the claimed pH value etc. condition.
It is also to be noted that applicant’s mentioned applicant’s specification (in PGPUB paragraph [0350]) recites respective viscosity profile at the values of 15%, 17% and 20% of gum acacia respectively within 2 minutes which is not achieved if the amount is less than 15% (e.g. 13.5%). However, claimed invention of claims 1, 11, 12, 15 do not claim the specific reconstitution time as is argued as unexpected result.
Applicants may consider to establish further data that the anti- lumping properties having no phase separation when a higher value of 10% Xanthan gum is achievable without having any phase separation as claimed in claims 1, 11, 12, 15.
Therefore, the unexpected result is not sufficient.
The rejection is made as non-final.
Conclusion
26. 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
Prosecution Insights