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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/15/2025 has been entered.
Status of the application
3. Claims 1, 3-26, 30-36, 38, 39 are pending in this application.
Independent claim 1 is amended.
Claims 1, 3-26, 30-36, 38, 39 have been rejected.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
5. Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 recites “sugar”. Claim 1 recites “sugar-free”. However, claim 14 depends on independent claim 1. Therefore, it is confusing and unclear and indefinite. Claim 14 should be amended to overcome 112 second paragraph rejection.
Claim Rejections - 35 USC § 103
6. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
6a. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6b. 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 are summarized as follows:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
7. Claims 1, 3, 4, 8-22, 25, 26, 30-33, 36 38, 39 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (CN 105580967 A) in view of Dorr et al. US 2015/0099033 A1 in view of Brendel et al. (WO 2016/001191 A, English Translation) and in view of NPL Thabius et al. (Conference paper 2013: presented, 10" World congress on preventive Dentistry 2013: Poster # 144) in view of Arima et al. USPN 4,556,565 in view of and as evidenced by NPL Dried maltitol and as evidenced by NPL Lycasin and as evidenced by Maskasky et al. (EP 0227444 A2).
8. Regarding claims 1, 4, 25, 26, 33, 36, Sun et al. discloses the method of making chewing gum which prevent decay of tooth which comprises a gum base in an amount of 20-30 wt.%, additives, sweetening agent, additives like flavoring agent, antioxidant etc. (at least in Abstract) and mixing them by heating at 40-50 degree C and flavoring agents, antioxidants as additives are added to the gum base (Abstract, page 2, last paragraph). Therefore, it meets optional step of adding “functional ingredient” in an amount ranging from 0.1-10 parts by weight of total wt. of the chewing gum (Abstract) to meet claims 1(2), 1(4), 1(6), 25, 26, 30-32 and 36. The disclosed gum base in an amount of 20-30 wt.% as disclosed by Sun et al. (Abstract) meets the claim limitation of independent claim 1(4) and claimed “15-20% by weight gum base ” of claim 25. Also, even if optional, it meets “additives” of claim 1(2). Sun et al. discloses the additives can include flavoring agents 0.1-5 parts by weight , 0.2-10 parts by weight of emulsifying agent etc. (at least in Abstract) which also meet claims 26, 36. 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 Sun et al. does not specifically mention the presence of fat and gelatin in the chewing gum composition. Therefore, these are considered as optional. It is to be noted that sweetening agent can be polyol also which is not sugar but having sweetening property. One of ordinary skill in the art may not select sugar, but polyol as sweetening agent in order to make it sugar-free, may not consider fat to make it fat-free and gelatin-free for specific customer’s need and use.
However, in addition, examiner has also considered another secondary prior art by Brendel et al.
Brendel et al. discloses that sugar-free, gelatin-free ([0027]) and fat-free (Title, [0024]) chewing gum composition used to make chewing gum ([0001], [0017], [0022]).
One of ordinary skill in the art would have been motivated to make fat-free because of having reduced calorie product as disclosed by Brendel et al. ([0003]) and sugar-free for reduced calorie (in Brendel et al. , [0003]) and having specific use for specific customer’s like obese and diabetes patient and gelatin free because of specific need for specific vegan population because it is known and evidenced by Maskasky et al. that Gelatin is globally derived from animal protein-typically, animal hides and bones etc. (page 6, paragraph 5).
Sun et al. is silent about claims 1(1).
Dorr et al. discloses a process of making chewing gum (at least in [0029]- [0035], [0044], [0055], [0075] – [0076], [0079], [0080], Examples). 1-3, claims 1-3) and the method includes tooth friendly polyol syrup ([0080], [0097], Examples, e.g., lycasin is maltitol, non-cariogenic) which can be mixed with gum base in liquid form and can be kneaded at warm temperature about 50 degree C (Examples 1-3). Therefore, Dorr et al. is analogous prior art. It is known and as evidenced by NPL Lycasin (page 1) that it is maltitol syrup (Page 1). Therefore, it meets ‘polyol syrup of claim 1 (1).
However, Dorr et al. is specifically silent about starch and polyol syrups (i.e., more than one polyol syrup).
Regarding claim 1(1), and claims 4, 33, it is to be noted that Dorr et al. discloses that tooth-friendly chewing gum can be prepared by introducing polyols and it includes lycasin syrup (i.e. maltitol as polyol syrup) having 10.6% by weight in the composition (Example 1, [0111], [0112]) having 25% water or if we consider disclosed Lycasin 80/55 (Example 1, [0111]), it is evidenced that identical Lycasin will have 50% water content as evidenced by NPL Lycasin (page 1), which will have about 50% of 10.6% ([0111], Ex 1 of Dorr et al.) i.e. 5.3% by weight water.
Regarding polyol syrups (i.e., more than one polyol syrup), of claim 1 (1) and claim 4, Dorr et al. discloses sorbitol in addition to lycasin syrup (Examples). Dorr et al. discloses that the confectionery product can include one or more bulk sweeteners which includes polyols e.g., xylitol, maltitol, sorbitol, mannitol etc. ([0080], [0081], in Example 1)
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sun et al. with the teaching of Dorr et al. to include polyol (s) as replacement of sugar which includes maltitol as polyol as lycasin syrup (i.e. maltitol as polyol syrup) which serves as tooth-friendly chewing gum.
Regarding the ratio between water from polyol syrup and starch hydrolysate as claimed in claim 1 (1), Brendel et al. discloses that gelatin-free ([0027]) and fat-free (Title, [0024]) chewing gum composition used to make chewing gum ([0001], [0017], [0022]). Brendel et al. discloses that starch hydrolysate 3-8% can be present in such a composition (Brendel, [0108], [0115]). Therefore, the claimed weight ratio of water from polyol syrup (about 5.3% by wt.), and starch hydrolysate 3-8% by weight (in Brendel et al. [0028], [0030], [0108], [0115]) meets between 1 and 4 as claimed in claim 1(1).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sun et al. in view of Dorr et al. by Brendel et al. to include starch hydrolysate in order to have enriched fiber source (at least in [0086], e.g., partially hydrolyzed starch derivative which contain up to 85% fiber) having many advantages as nutritional component in the composition ([0086], [0087]).
It is also considered as Result Effective Variable.
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 polyol syrup and thickener (i.e. modified starch, maltodextrin etc.) in Sun et al. in view of Brendel et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired increased body and strength which may be necessary for efficient sheeting of the gum (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).Brendel et al. discloses that starch hydrolysate is an enriched fiber source (at least in [0086]).
Regarding optional step of claim 1(5) and claim 3, it is to be noted that Dorr et al. discloses that sorbitol and/or maltitol can be added from 21-49 wt.% (at least in [0086]). However, Dorr et al. or any combinations of prior art do not teach “at least 50% of the powder fraction composed of non-cariogenic ingredients is introduced in step 3) and the remainder of the powder fraction is introduced in step 5)” as claimed in claim 3. It is to be noted that one of ordinary skill in the art may consider to include some additional powder form of non-cariogenic polyol (e.g., maltitol) to incorporate at the step 5) with a reasonable expectation of success to achieve good mixing in the liquid phase compared to the addition of the total large amount at a time.
Absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to introduce into at least 50% of the powder fraction composed of non-cariogenic ingredients is introduced in step 3) and the remainder of the powder fraction is introduced in step 5)” in order to have good mixing in the liquid phase compared to the addition of the total large amount at a time. as claimed in claim 3.
Regarding the claim limitation of “ wherein the entire process is carried out at a temperature of between 30-60 degree C “ as claimed in amended claim 1, and also the claimed range value of temperature as claimed in claims 30, 31, 32, Sun et al. discloses that mixing the ingredients by heating at 40-50 degree C and flavoring agents, antioxidants as additives are added to the gum base (Abstract, page 2, last paragraph). Arima et al. discloses , in particular, that polyol e.g. sorbitol , starch hydrolysate , gum base containing mixture can be added and kneaded uniformly at 55 degree C (at least col 6 lines 44-50) and temperature can be 50 degree C also ( col 7 lines 15-17).
Therefore, one of ordinary skill in the art can perform the step of mixing at the step 1(1), followed by addition of gum base to mix at the same temperature which meets all the entire process at the claimed range temperature between 30-60 degree C as claimed in claim 1.
However, they 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".
The difference between claim 1 and the disclosed mixing step as disclosed by Arima et al. is claim 1 claim first mixing polyol and starch hydrolysate to make ‘chewing paste’ followed by mixing such ‘chewing paste’ with gum base.
It is within the skill of one of ordinary skill in the art to optimize the proportion of the amount of water introduced by the polyol and the amount of starch from within the disclosed amount which will meet the claimed amount and proportion in order to achieve desired consistency of all the components together which is “paste” consistency to achieve desired softness and good texture and then to be considered to mix with gum base with a reasonable expectation of success to make final chewing gum product having good and desired organoleptic property .
It is to be noted that and as discussed above that the disclosed amount and proportion of water introduced by the polyol syrup and the amount of starch used are identical to and meets the claimed proportion as claimed in claim 1(1). Therefore, it will have the claimed property of having in paste form. Also “chewing paste” is considered as the consistency. Therefore, mixing condition (Time and temperature) are also optimizable within the disclosed temperature from the temperature range which meets claimed temperature range in order to achieve desired claimed chewing paste consistency.
Regarding claims 1, 30-32, if we consider the broadly disclosed temperature range as disclosed by Sun et al. (Abstract, page 2, last paragraph) and Arima et al. (in Examples) as discussed above, it would have been obvious that it can be interpreted that such ingredients can be mixed at this broadly disclosed range temperature and the final desired texture of chewing paste type consistency can be achieved by considering temperature and time of mixing. The reason is the more the temperature within the disclosed range value , time may be less to achieve paste consistency with desired water content suitable to contribute paste consistency. One of ordinary skill in the art can optimize the temperature from the disclosed range value of temperature by optimizing time of mixing in a way so that the mixed composition can have chewing paste like consistency to be ready for the next step of combining with gum base.
Therefore, mixing condition (Time and temperature) are also optimizable within the disclosed temperature from the temperature range which meets claimed temperature range in order to achieve desired claimed “chewing paste consistency”. This is optimizable.
Absent showing of unexpected results, the specific amount of temperature is not considered to confer patentability to the claims. As the texture, consistency are variables that can be modified, among others, by adjusting the amount of time , 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 time of mixing in Sun et al. in view of Arima et al. to amounts, including that presently claimed, in order to obtain the desired effect e.g. taste, texture and chewing paste consistency of the mixture to be added to gum base (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).
The above discussion meets claim limitation of claim 1(3) and also “ the amended claim limitation of “wherein the entire process is carried out at a temperature of between 30-60 degree C “ as claimed in amended claim 1 .
9. Regarding claims 14, 15, 17, 18, 19, Sun et al. discloses sweetening agent (Abstract).
Dorr et al. discloses that chewing gum composition contains sugar alcohol (i.e., polyol) ([0080]) and lycasin syrup ([0114], Examples). It is known and as evidenced by NPL Lycasin syrup that Lycasin syrup is maltitol syrup (Page 1). Dorr et al. also discloses that the polyol maltitol can be used in combination with Lycasin syrup (i.e., maltitol syrup) (at least in [0080], Example 3, [0132]). Therefore, it would have been obvious that it can be maltitol powder in an amount of 44% by weight (Ex 3, [0132]) which meets claims 17-19. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
NPL Thabius et al. discloses that maltitol powder is good to serve as remineralization of dental enamel (Abstract and Conclusion). Therefore, one of ordinary skill in the art would have been motivated to consider maltitol as maltitol powder additionally in addition to liquid maltitol present in lycasin syrup as disclosed by formulation of Dorr et al. (Example 3) with a reasonable expectation of success to get the immediate benefit of protecting dental health because maltitol powder is good to serve as remineralization of dental enamel as disclosed by NPL Thabius et al. (Abstract and Conclusion).
10. Regarding claim 16, NPL Thabius et al. discloses that maltitol is dry (i.e., dehydrated) form as powder (Abstract). Therefore, it can be dehydrated syrup in dry powder form.
11. Regarding claims 8-12, 13, 20-22, 38, 39, Brendel et al. discloses that starch hydrolysate 3-8% and vegetable fiber 6 wt.% starch (Brendel, [0108], [0115]). Brendel et al. also discloses that starch hydrolysate can be maltodextrin having DE 2.0 ([0028]). Brendel et al. also discloses that maltodextrin (i.e., resistant starch) serves as a source of vegetable fiber and may be mixed with additional vegetable fiber too ([0030]). This meet claims 8-12, 13, 20-22, 38, 39.
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sun et al. in view of Dorr et al. by Brendel et al. to include starch hydrolysate in order to have enriched fiber source (at least in [0086], e.g., partially hydrolyzed starch derivative which contain up to 85% fiber) having many advantages as nutritional component in the composition ([0086], [0087]).
12. Regarding claims 20-22, Sun et al. is silent about soluble fiber in the composition. NPL Thabius et al. discloses that maltitol powder is good to serve as remineralization of dental enamel (Abstract and Conclusion). Therefore, one of ordinary skill in the art would have been motivated to consider maltitol as maltitol powder additionally in addition to liquid maltitol present in lycasin syrup as disclosed by formulation of Dorr et al. (Example 3) with a reasonable expectation of success to get the immediate benefit of protecting dental health because maltitol powder is good to serve as remineralization of dental enamel as disclosed by NPL Thabius et al. (Abstract and Conclusion).
13. Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. ( CN 105580967 A) in view of Dorr et al. US 2015/0099033 A1 in view of Brendel et al. (WO 2016/001191 A, English Translation) and in view of NPL Thabius et al. (Conference paper 2013: Poster # 144) in view of Arima et al. USPN 4,556,565 and as evidenced by NPL Dried maltitol and as evidenced by NPL Lycasin as applied to claim 1 and further in view of Pedersen et al. USPN 4263327 A.
14. Regarding claims 5-7, Dorr et al. discloses sorbitol in addition to lycasin syrup (Examples). however, Dorr et al. does not mention sorbitol syrup.
Pedersen et al. discloses that sorbitol in syrup form is beneficial to serve as plasticizer, good for ready mix with gum base and is cheaper than solid form having 70-90% (at least in col 2 lines 45-55).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sun et al. in view of Dorr et al. in view of Brendel et al. to include the teaching of Pedersen et al. to consider sorbitol in syrup form which is beneficial to serve as plasticizer, is good for ready mix with gum base and is cheaper than solid form (at least in col 2 lines 45-55) having 70-90% (at least in col 2 lines 45-55).
Therefore, Dorr et al. discloses that the confectionery product can include one or more bulk sweeteners which includes polyols e.g., xylitol, maltitol, sorbitol, mannitol etc. ([0080], [0081] , in Example 1, sorbitol and lycasin (i.e. maltitol syrup) ) in an amount sorbitol 24% plus Lycasin 10% to meet 34.6% by weight by weight of the chewing gum composition to meet claims 5, 6, 7. 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).
15. Claims 23, 24, 34, 35 are rejected under 35 U.S.C. 103 as being unpatentable over Sun et al. (CN 105580967 A) in view of Dorr et al. US 2015/0099033 A1 in view of Brendel et al. (WO 2016/001191 A, English Translation) and in view of NPL Thabius et al. (Conference paper 2013: Poster # 144) in view of Arima et al. USPN 4,556,565 and as evidenced by NPL Dried maltitol and as evidenced by NPL Lycasin as applied to claim 1 and further in view of Ribadeau-Dumas et al. USPN 5580601.
16. Regarding claims 23, 24, 34, 35, the combined teachings of Sun et al. in view of Dorr et al. in view of Brendel et al. and NPL Thabius et al. disclose maltitol is non-cariogenic and is in powder form (At least in NPL Thabius et al. Abstract and Conclusion).
However, they are silent about the particle size of the non-cariogenic ingredient as claimed in claims 23, 24, 34 and 35.
Ribadeau-Dumas et al. discloses that maltitol having less than 60-micron size used in such a composition can have excellent textural quality with stability if the particle size is 60 micron or less (col 3 lines 50-60).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Sun et al. in view of Brendel et al. to include the teaching of Ribadeau-Dumas et al. who discloses that maltitol used in such a composition can have excellent textural quality with stability if the particle size is 60 micron or less (col 3 lines 50-60).
Response to arguments
17. Applicants’ arguments and amendments have been considered. Applicants’
arguments and amendment of independent claim 1 overcome the rejections of record. Examiner has used a new secondary prior art by Arima et al. to address the
amended claim limitation of “wherein the entire process is carried out at a temperature
of between 30-60 degree C”.
18. Applicants argued in remarks section, last two lines of page 5 continued to first two lines of page 6 that “Brendel’s process is not carried out in a single , continuous operation; on the contrary, it first requires the preparation of a chewing paste, which must be cooked at a temperature above 100 degree C in a cooker, and only thereafter the mixing of this cooked chewing paste with gum base in a separate mixer”.
In response, it is to be noted that Brendel et al. is used as secondary prior art only to address the amounts of starch hydrolysate to be used in Brendel’s sugar-free, fat-free and gelatin-free chewing gum composition. Examiner did not consider Brendel’s method of making chewing gum which is different than claimed method of making chewing gum. Examiner also used another secondary prior art by Arima et al. to address that the mixing steps of claim 1(1) and claim 1(4) can be performed at a temperature of 55 degree C which meets “entire claimed process is carried out at temperature of 30-60 degree C” as claimed in amended claim 1. Regarding the “chewing paste”, examiner addressed it without Brendel’s “chewing paste”.
19. Applicants’ arguments in remarks, page 6, last paragraph which is based on prior filed Affidavit of Declaration as filed January 17, 2023) has been considered.
In response, it is to be noted that Affidavit of Declaration as filed January 17, 2023 considered maltodextrin as starch derivative and considered prior used prior art which is not used in this office action.
However, it is to be noted that, most importantly, in this instance, at least, claim 1 is broad and claims broadly “starch hydrolysate” (Genus) and does not claim maltodextrin (species) with a specific range amount in independent claim 1.
Applicant’s may consider further amendment of independent claim 1 based on the points as discussed above in order to overcome the rejections of record and/or which amendment of independent claim 1 may be helpful to establish criticality of the claimed invention of further amended claim 1.
Regarding the establishment of criticality of the claimed invention of further amended independent claim 1, applicants may consider to establish unexpected results over a claimed range, by comparing a sufficient number of tests both inside and outside (i.e. as well as the upper and lower limits) the claimed range of the further amended independent claim 1 in order to show the criticality of the claimed range. In re Hill 284 F.2d 955, 128 USPQ 197 (CCPA 1960). See MPEP 716.02.
Therefore, the rejection is made as non-final.
Conclusion
20. 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