DETAILED ACTION
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 . Claims 1, 3-4, 6-8 and 15-21 are examined herein, wherein claims 9-14 and 22 have been withdrawn.
Claim Interpretation
With regard to the prior art, the claim 21, encompasses: A composition for preparing a candy, comprising:
a total amount of saccharides, based on dry solids, including:
any amount of saccharides having a degree of polymerization of 2 or less, based on the total amount of saccharides, including:
37 parts by weight of any type of white sugar; and
8 parts by weight of maltitol, and 5 to 10 parts by weight of allulose; and
35.7 to 41.8 parts by weight of saccharides having a degree of polymerization of 3 or more, based on 100 parts by weight of the any amount of saccharides having a degree of polymerization of 2 or less, including:
isomaltooligosaccharides; and
starch syrup;
c. wherein the amount of saccharides having a degree of polymerization of 3 or more, based on 100% of any amount of saccharides having a degree of polymerization of 2 or less, calculates to about 0.036 to 42 wt% of the any amount of saccharides having a degree of polymerization of 3 or more, because any amount is open to from 0.1 to 99.99 wt%, wherein 35.7 to 41.8 parts by weight of 0.1 is about 0.036 to 0.04 wt% and 35.7 to 41.8 parts by weight of 99.9 wt% is about 36 to 42 wt%.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-4, 6-8 and 15-21, are rejected under 35 U.S.C. 103 as being unpatentable over Kasarle.
Kasarle: published as WO 2018/029698 A1 on 15-Feb-2018
Independent claim 1
Hard candy
Kasarle teaches methods of making hard candies (see the 2nd para. from the bottom of pg. 12), comprising multiple types of saccharides, including: psicose (i.e. allulose) (see the last para. on pg. 10), as claimed.
No xylo-oligosaccharides
Although Kasarle provides the use of one or more saccharides, including: xylo-oligosaccharides (2nd para. from the bottom of pg. 14), Kasarle also shows it was known for hard candies to be made without xylo-oligosaccharide in the examples and the claims, therefore one in the art would envisage a hard candies made without the use of xylo-oligosaccharide, as claimed, because if this was desired for exclusion, there are other options of the one or more type of saccharides to select from, and the use of xylo-oligosaccharides is not shown to have criticality as it is not used in the examples or the claims, therefore it’s use is made optional.
Therefore, it would have been obvious to one of skill in the art, at the time of filing to modify the method of making hard candies, as Kasarle, to include no xylo-oligosaccharides, -------------------as claimed, because: Kasarle shows it was known for hard candies to be made without xylo-oligosaccharide in the examples and the claims, therefore the teaching provides that such a thing was successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select this, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use (see MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious); and further provides other options of saccharides to select from wherein the use of xylo-oligosaccharides are not shown to have criticality as it is not used in the examples or the claims therein, therefore one in the art would envisage the use of xylo-oligosaccharide as being optional for exclusion based on the other options and compositions available.
No cello-oligosaccharides
Although Kasarle also teaches the use of one type of cellooligosaccharide, cellobiose (last para. on pg. 10), this is a disaccharide, meaning it has a degree of polymerization of 2, and the teaching provides no cello-oligosaccharide saccharides having a degree of polymerization of 3 or more.
In the alternative, Kasarle provides the optional use of cellobiose by teaching at least one from a group of saccharides (last para. on pg. 10), one in the art would envisage a hard candies made without the use of cellooligosaccharide, as claimed.
Therefore, it would have been obvious to one of skill in the art, at the time of filing to modify the method of making hard candies, as Kasarle, to include no cellooligosaccharides, -------------------as claimed, because Kasarle provides:
1. the use of a single cellooligosaccharide as being optional, therefore one in the art would envisage hard candies made without its use, and in light of the pending Specification, the type of cellooligosaccharide disclosed are saccharides that have a degree of polymerization of 3 or more (see pending para. 0036), whereas Kasarle only teaches the use of a type of cellooligosaccharide, cellobiose (last para. on pg. 10), that is a disaccharide, meaning it has a degree of polymerization of 2, therefore the teaching provides no cello-oligosaccharide saccharides having a degree of polymerization of 3 or more, as encompassed by the claim; and
2. since Kasarle shows it was known for hard candies to be made without cellooligosaccharide having a degree of polymerization of 3 or more, the teaching provides that such a thing was successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select this, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Dry solids content
Since Kasarle provides the making of a hard candy composition (e.g. a dry solid), the amounts of ingredient therein are toward dry solids, as claimed.
Type of saccharides, having a degree of polymerization of 2 or less (i.e. allulose)
When looking for light in the pending specification, it was noted that saccharides having a degree of polymerization of 2 or less include: allulose (see pending para. 0031 and original claim 2). Synonyms of allulose include: D-allulose, D-psicose, D-ribo-2-hexulose, D-ribo-2-ketohexose, psicose, psicose (D)-isomer and psicose (L)-isomer.
Kasarle provides the saccharides, include at least one type, including: psicose (i.e. saccharides having a degree of polymerization of 2 or less) (see the last para. on pg. 10).
Type of saccharides, having a degree of polymerization of 3 or more
When looking for light in the pending specification, it was noted that saccharides having a degree of polymerization of 3 or more, include: isomaltooligosaccharides, fructooligosaccharides, soyoligosaccharides, and/or cellooligosaccharides (pending para. 0036, and pending claim 3).
Kasarle provides the saccharides, include at least one type, including: isomaltooligosaccharides, fructooligosaccharides, soybean oligosaccharides (last para. on pg. 10) and/or chitosan (i.e. a cello-oligosaccharides) (last para. on pg. 13).
Mixture of saccharides, including: saccharides having a degree of polymerization of 2 or less (i.e. allulose) and saccharides having a degree of polymerization of 3 or more (i.e. isomalto-oligosaccharides, fructo-oligosaccharides and/or soy-oligosaccharides)
Kasarle provides the saccharides, include at least one of:
allulose (i.e. psicose), a saccharide having a degree of polymerization of 2 or less, as discussed above (last para. on pg. 10); and
at least one type, including: isomaltooligosaccharides, fructooligosaccharides, and/or soybean oligosaccharides, a saccharide having a degree of polymerization of 3 or more (last para. on pg. 10).
Broad amounts of saccharides
Kasarle broadly provides that the use of low glycemic index nutritive ingredients, including saccharides (3rd para. from the bottom of pg. 3), in an amount of 0.1 to 99.99 wt% of the total composition (ab.).
Amount of saccharides having a degree of polymerization of 3 or more
The claim is open to any amount of saccharides having a degree of polymerization of 2 or more, therefore 29 parts or more of saccharides having a degree of polymerization of 3 or more, based on the amount of saccharides having a degree of polymerization of 2 or less, calculates to 29 parts of about 0.1 wt% to 29 parts of about 99.9 wt%: about 0.029 to 29 wt% of saccharides having a degree of polymerization of 3 or more.
Kasarle provides that the use of low glycemic index nutritive ingredients (i.e. carbohydrates, i.e. saccharides) in an amount of 0.1 to 99.99 wt% of the total composition (ab.).
Therefore, Kasarle provides broad non limiting range of the amounts of the psicose saccharide and (iso, fructo or soy) oligosaccharides saccharides, which means that the ratio of these two types of saccharides, encompass the claim of:
5 to 10 parts by weight of saccharides having a degree of polymerization of 2 or less (i.e. allulose, i.e. psicose, as discussed above), based on dry solids weight of the saccharides; and
29 parts by weight or more of saccharides having a degree of polymerization of 3 or more (i.e. isomalto-oligosaccharides, fructo-oligosaccharides, or soy-oligosaccharide, as discussed above), based on 100 parts by weight of the saccharides having a degree of polymerization of 2 or less (i.e. allulose, i.e. psicose), based on dry solids weight of the saccharides.
As set forth in MPEP 2144.05, in the case where the claimed range “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).
In the alternative, for specificity, Kasarle also provides an embodiment wherein isomalto-oligosaccharides, fructo-oligosaccharides, and/or soy-oligosaccharide (i.e. saccharides having a degree of polymerization of 3 or more) are used in an amount of 1 to 30 wt% (4th full sentence on pg. 11), which encompasses the use of 0.029 to 29 wt% of saccharides having a degree of polymerization of 3 or more, as required of the claim. As set forth in MPEP 2144.05, in the case where the claimed range “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).
Amount of saccharides having a degree of polymerization of 2 or less
Kasarle provides an embodiment wherein allulose (i.e. psicose) (i.e. saccharides having a degree of polymerization of 2 or less), is used in an amount of 1 to 10 wt% (7th full sentence on pg. 11), which encompasses 5 to 10 parts by weight of saccharides having a degree of polymerization of 2 or less (i.e. allulose, i.e. psicose, as discussed above), based on dry solids weight of the saccharides. As set forth in MPEP 2144.05, in the case where the claimed range “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).
Amounts of saccharides based on dry solids
Since the teaching above provide that the made composition is a hard (i.e. solid) candy, all of the amounts herein are by dry solid content, as claimed.
Independent claim 21
Claim 21 differs from claim 1, wherein the references applied in the rejection above, as incorporated herein, as further requiring:
37 parts by weight of white sugar; and
8 parts by weight of maltitol, and
about 0.036 to 42 wt% of a combination of isomalto-oligosaccharides and starch syrup.
Kasarle provides the saccharide, includes:
sucrose and invert sugar, both commonly known as white sugar (3rd full para. on pg. 14);
maltitol (2nd full para on pg. 14); and
a combination of isomalto-oligosaccharides and starch syrup (3rd full para. on pg. 14).
As for 37 parts by weight of white sugar: Kasarle provides an embodiment wherein invert sugar is used in an amount of 1 to 40 wt% (3rd full sentence on pg. 11), which encompasses the use of 37 parts by weight of white sugar, as claimed. As set forth in MPEP 2144.05, in the case where the claimed range “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).
As for 8 parts by weight of maltitol: Kasarle provides an embodiment wherein maltitol is used in an amount of 0.1 to 10 wt% (4th line from the bottom of the last full para. on pg. 10), which encompasses the use of 8 parts by weight of maltitol, as claimed. As set forth in MPEP 2144.05, in the case where the claimed range “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).
As for about 0.036 to 42 wt% of a combination of isomalto-oligosaccharides and starch syrup: Kasarle provides an embodiment wherein a combination of isomalto-oligosaccharides and starch syrup are used in an amount of 1 to 50 wt% (2nd full sentence on pg. 11), which encompasses about 0.036 to 42 wt% of a combination of isomalto-oligosaccharides and starch syrup, as claimed. As set forth in MPEP 2144.05, in the case where the claimed range “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).
Dependent claims
As for claim 3, the modified teaching, in Kasarle and Mitsuyo provide the use of xylo-oligosaccharides, as discussed above.
As for claim 4, Kasarle provides an embodiment wherein allulose (i.e. psicose) (i.e. saccharides having a degree of polymerization of 2 or less), is used in an amount of 1 to 80 wt% (last full sentence on pg. 10), which encompasses 70 to 77 parts by weight of saccharides having a degree of polymerization of 2 or less (i.e. allulose, i.e. psicose, as discussed above), based the total weight of the composition made.
As set forth in MPEP 2144.05, in the case where the claimed range “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).
As for wherein 100 parts by weight of the dry solids of the composition for preparing a candy, since the teaching above provides that the made composition is a hard (i.e. solid) candy, all of the amounts herein are by dry solid content as claimed.
As for the sum of the parts by weight of the saccharides having a degree of polymerization of 2 or less and the parts by weight of the saccharides having a degree of polymerization of 3 or more is 100 or less: As discussed above, Kasarle provides the use of low glycemic index nutritive ingredients, including saccharides (see the Summary) in an amount of 0.1 to 99.99 wt% of the total composition (ab.), which encompasses the sum of the parts by weight of the saccharides having a degree of polymerization of 2 or less and the parts by weight of the saccharides having a degree of polymerization of 3 or more is 100 or less, as claimed.
As for claim 6, the claim is open to any amount of saccharides having a degree of polymerization of 2 or more, therefore 29 to 50 parts or more of saccharides having a degree of polymerization of 3 or more, based on the amount of saccharides having a degree of polymerization of 2 or less, which calculates to: 29 parts of about 0.1 wt% to 50 parts of about 99.9 wt%: about 0.029 to about 50 wt% or more of saccharides having a degree of polymerization of 3 or more.
As discussed above, Kasarle provides an embodiment wherein isomalto-oligosaccharides, fructo-oligosaccharides, and/or soy-oligosaccharide (i.e. saccharides having a degree of polymerization of 3 or more) are used in an amount of 1 to 30 wt% (4th full sentence on pg. 11), which encompasses the use of 0.029 to 50 wt% or more of saccharides having a degree of polymerization of 3 or more, as required of the claim.
As for claim 7, the claim requires 23 to 35 parts by weight of the saccharides having a degree of polymerization of 3 or more of, based on a total of 100 parts by weight of the composition. As discussed above, Kasarle provides an embodiment wherein isomalto-oligosaccharides, fructo-oligosaccharides, and/or soy-oligosaccharide (i.e. saccharides having a degree of polymerization of 3 or more) are used in an amount of 1 to 30 wt% (4th full sentence on pg. 11), wherein the use of low glycemic index nutritive ingredients, including saccharides (see the Summary) in an amount of 0.1 to 99.99 wt% of the total composition (ab.), which encompasses the use of 23 to 35 parts by weight of the saccharides having a degree of polymerization of 3 or more of, based on a total of 100 parts by weight of the composition, as required of the claim.
As for the sum of the parts by weight of the saccharides having a degree of polymerization of 2 or less and the parts by weight of the saccharides having a degree of polymerization of 3 or more is 100 or less: As discussed above, Kasarle provides the use of low glycemic index nutritive ingredients, including saccharides (see the Summary) in an amount of 0.1 to 99.99 wt% of the total composition (ab.), which encompasses the sum of the parts by weight of the saccharides having a degree of polymerization of 2 or less and the parts by weight of the saccharides having a degree of polymerization of 3 or more is 100 or less, as claimed.
As for claim 8, since the modified teaching provides a similar composition comprising similar amounts of similar ingredients, to make candy which reflects the breadth of the claim composition, it would be reasonable to expect that the composition has an average molecular weight of 29,000 to 45,000 g/mol, absent a showing of criticality, because the teaching of a similar composition imparts a suggestion in or expectation that the composition taught will have the same or a similar utility.
Therefore, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making candy compositions, comprising: saccharides having a DP of 2 or less and other saccharides having a DP of 3 or more, to include that said composition will have an average molecular weight of 29,000 to 45,000 g/mol, as claimed, because the composition established through the teachings by Mitsuyo provides a sufficiently close relationship between the ingredients to create an expectation that such a similar compositions would have similar capabilities, properties or functionality.
As for claim 15, the modified teaching provides that the composition is for preparing a hard candy, as discussed above.
As for claims 16-17, since the modified teaching provides a similar composition comprising similar amounts of similar ingredients, to make candy which reflects the breadth of the claim composition, it would be reasonable to expect that the composition functions: wherein a force required to detach a probe in contact with the candy surface after exposing the candy to 90% humidity and 50°C for 10 minutes, is 750 g or less, as in claim 16; and wherein a weight increase amount after exposing the candy to 90% humidity and 50°C for 3 hours is 9.5% or less, as in claim 17, absent a showing of criticality, because the teaching of a similar composition imparts a suggestion in or expectation that the composition taught will have the same or a similar utility.
As for claim 18, the claim is open to any amount of saccharides having a degree of polymerization of 2 or more, therefore 35.6 to 44 parts of saccharides having a degree of polymerization of 3 or more, based on the any amount of saccharides having a degree of polymerization of 2 or less, which calculates to: 35.6 parts of about 0.1 wt% to 44 parts of about 99.9 wt%: about 0.036 to about 44 wt% of saccharides having a degree of polymerization of 3 or more.
As discussed above, Kasarle provides an embodiment wherein isomalto-oligosaccharides, fructo-oligosaccharides, and/or soy-oligosaccharide (i.e. saccharides having a degree of polymerization of 3 or more) are used in an amount of 1 to 30 wt% (4th full sentence on pg. 11), which encompasses the use of 0.036 to 44 wt% of saccharides having a degree of polymerization of 3 or more, as required of the claim.
As for claim 19, Kasarle provides the use of at least one selected from the group consisting of: glucose, fructose, galactose, maltose, isomaltose, sugar, and lactose (see last para. on pg. 10), as claimed.
As for claim 20, all of the limitations herein are discussed in the rejection of claim 21 above.
Response to Arguments
Obviousness rejections
In response to the previous office action, Applicant amended the claim to recite “consisting” instead of “comprising”. And, asserts that Kasarle’s sweetnener composition necessarily includes the glucoseoxidase enzyme (GOD), while pointing to the abstract of Kasarle, to demonstrate that Kasarle fails to disclose the claimed invention. Applicant further argues that one of ordinary skill in the art would have no reason to modify Kasarle’s composition to include only the claimed saccharides.
Applciant’s claim amendment, assertion and argument has been considered. However, it is not found persuasive. Given the prior art rejection issued against the pending and examined claims is obviousness type rejection, the Office acknowledges that Kasarle does not teach the claimed invention. Had Kasarle teach the claimed invention, the prior art rejeciotn would haven been anticipatory type rejection. With respect to the assertion that the composition of Kasarle “necessarily” have GOD, Applciant’s attention is directed toward the working examples provided by Kasarle, starting at page 22 of Kasarle. At the cited passages, Kasarle teaches mixing saccharides before adding GOD. In the instant case, a composition comprising the sugars and GOD is Kasarle’s intended final product. And, the mixed saccharides is the intermediary product. It is the intermediary product that render the claimed invention obvious for the reason(s) set forth above. Given this teaching, Kasarle teaches a composition without GOD. And, because Kasarle teaches a composition without GOD, there is no need for one of ordinary skill in the art to modify the teachings of Kasarle as the addition of GOD is made after an intermediary product is formed.
As for unexpected results, although the data in the Specification is appreciated, it does not amount to a proper showing of unexpected results. A proper showing of unexpected results must provide significant scientific and statistical experimental results, that show that the result is due only to what is explicitly claimed in comparison to the closest prior art (whatever referenced composition Applicant believes is the closest invention to their own at the time of filling).
This showing of unexpected results must provide how the range for each component is established, wherein only when used at the claimed value that the result occurs. There are many design of experiment (DOE) methods Applicant can implore for this undertaking, for example a full factorial design.
Then, experimental runs also have to be made on the closest prior art, to show that the unexpected result does not occur; and finally, the runs must be repeated enough time to show statistical practicality.
The experiment showing unexpected results would then have to be presented to the office in a declaration that includes all of the details of the experimentation, including the following:
1. Evidence of unexpected results must be in the form of a direct comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. The showing of unexpected results must be commensurate in scope with the invention as claimed. See MPEP 716.02(d).
2. The declaration must provide:
a. A description of precisely what was tested. It must include both:
b. The invention as claimed, AND
c. The closest prior art
d. A description of all of the test conditions.
e. Test results. The results must include:
i. The actual steps carried out, the materials employed, and the results obtained should be spelled out. Nothing concerning the work relied upon should be left to conjecture.
ii. The results of the test performed on the invention as claimed.
iii. The results of the test performed on the closest prior art.
iv. A showing of statistical and practical significance of the unexpected results. (i.e. several data points that confirm the test result was not just a statistical flier.)
f. An analysis of the test results, including, wherein the results must be due to the claimed features (including how the ranges for the components are established, in other words how the specifically claimed ranges provide the unexpected result), not to unclaimed features.
Therefore the argument above is not persuasive.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Barkalow also teaches methods of making hard candy with encompassing amounts of saccharides having a DP of 2 or less, including allulose (ab.); and saccharides having a DP of 3 or more, including FOS (0028).
Barkalow: published as WO 2017059352 A1 on 4/06/2017.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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