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 .
This office action is in regard to the application filed on June 8, 2022 and in response to a Request for Continued Examination filed on August 6, 2025.
Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 6, 2025 has been entered.
Status of Application
The amendment filed August 6, 2025 has been entered. Claims 1-9 and 11-14 are currently pending in the application. Claims 1 and 3 have been amended; claim 10 has been canceled. Claims 1-9 and 11-14 are hereby examined on the merits.
The previous objection to claim 3 has been withdrawn in light of applicant’s claim amendments.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Arenz et al. (US PG Pub. 2008/0184992) in view of Mergelsberg et al. (US Patent 5,167,981; cited on PTO-892 dated Sept. 25, 2024) and Wach et al. (US PG Pub 2010/0267658; listed in IDS dated June 8, 2022), herein after referred to as Arenz, Mergelsberg, and Wach respectively.
Regarding claims 1 and 3, Arenz teaches a method for preparing a hard caramel, comprising the steps of:
providing an aqueous solution (i.e., medium) [0040] comprising 50 wt.% isomaltulose [0013],
concentrating the solution by applying a vacuum (i.e., reduced pressure) to the aqueous solution while boiling [0040] at a temperature of 135°C or less [0042],
cooling the aqueous solution thereby obtaining a plastic mass,
shaping (i.e., moulding) the solution obtained in step c, thereby obtaining a hard caramel [0040],
wherein the aqueous solution provided in step a is heated to a temperature of 120°C, or lower than or equal to 125°C [0042], prior to applying a vacuum in the concentration step (step b) in a process step a1 [0040].
Since the vacuum taught by Arenz is not required in the taught process (but is used in the present rejection), the heating step prior to the application of the vacuum and the subsequent cooling step [0040] are considered to be done at atmospheric pressure.
The temperature taught by Arenz in step a1, lower than or equal to 125°C, encompasses the claimed ranges of 80-100°C of claim 1 and 85-95°C of claim 3. 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). See MPEP 2144.05.I.
Arenz is silent as to that the medium is cooled to a temperature of 70-90°C, but does teach that the mass is cooled [0040]. Generally, differences in temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.II. Since temperature of a process step is a known variable that affects various properties of a resulting composition, temperature is a result-effective variable.
Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed temperature range through no more than routine optimization, as varying the cooled temperature of the aqueous medium/plastic mass would achieve recognized results. Thus, the parameters of the cooled temperature taught by Arenz renders obvious the instant claim limitation.
Arenz is silent as to that the application of a reduced pressure is at most 0.4 bar and is with mixing.
Mergelsberg, in the same field of invention, teaches a method for preparing a hard candy containing sugar substitutes wherein a concentrating step is done by applying a vacuum (i.e., reduced pressure) with mixing (claim 1) at a pressure of down to 0.05 bars (claim 2).
The pressure range (down to 0.05 bars) taught by Mergelsberg overlaps with the claimed range of at most 0.4 bar. 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).
Therefore, as it was known in the art to produce a hard caramel/candy comprising sugar substitutes with a pressure reduction step, it would have been obvious to have produced a hard caramel at the reduced pressure as claimed, by modifying the method of Arenz, as Mergelsberg teaches that hard candies are known to be produced with a step of the application of a reduced pressure to an aqueous solution at the claimed pressure.
Mergelsberg teaches a reduced pressure for an application of a vacuum to an aqueous solution where Arenz is silent, thereby offering a guideline as to a suitable pressure. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the concentration/vacuum step of Arenz to have the pressure of Mergelsberg, thereby arriving at the claimed invention, with the reasonable expectation that the pressure is suitable for use in the claimed reduced pressure step.
Arenz and Mergelsberg are silent as to that the hard caramel contains a trehalulose-containing composition or that the aqueous medium contains a trehalulose-containing composition in an amount of 50-100 wt.% (based on the total dry substance) comprising 5-50 wt.% of isomaltulose and 20-95 wt.% of trehalulose (each based on dry substance of the trehalulose-containing composition). Arenz does teach that the hard caramel comprises 50 wt.% or more of isomaltulose [0013].
Wach, in the same field of invention, teaches a hard caramel [0067] containing a trehalulose-containing composition (claims 8 and 15) wherein an aqueous medium contains 92.34 wt.% of the trehalulose-containing composition (based on total dry substance) [0126] and wherein the trehalulose-containing composition comprises 8-50 wt.% isomaltulose (based on dry matter) (claim 7) and 20-95 wt.% trehalulose (based on dry matter) (claim 6). These ranges taught by Wach are the same or lie within the claimed ranges of claim 1.
Wach teaches that both isomaltulose and trehalulose are sugar substitutes [0003] that are useful, in the form of a trehalulose-containing composition, in nutritional compositions for their known physiological properties such as non-cariogenity and slow hydrolyses rate in the small intestine [0009]. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Arenz and Mergelsberg by incorporating the trehalulose-containing composition and trehalulose of Wach into the aqueous solution containing isomaltulose of Arenz at the claimed concentrations. One would have been motivated to make this modification for the benefit of incorporating an additional sugar substitute that is non-cariogenic and has a slow hydrolyses rate in the small intestine.
Regarding claim 2, as set forth above with regard to claim 1, Wach teaches the aqueous medium containing 92.34 wt.% (which lies within the claimed range) of the trehalulose-containing composition (based on total dry substance) [0126] comprising 8-50 wt.% isomaltulose (based on dry matter) (claim 7) and 20-95 wt.% trehalulose (based on dry matter) (claim 6). The amounts of isomaltulose and trehalulose taught by Wach encompass the claimed ranges of 15-25 wt.% and 75-85 wt.%, respectively. 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).
Regarding claim 4, the temperature range of step b taught by Arenz (135°C or less [0042]) overlaps with the claimed range of 120-135°C. 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).
Regarding claim 5, modified Arenz teaches that the process is continuous (Arenz: [0040]; Mergelsberg: claim 1).
Regarding claim 6, modified Arenz teaches that the composition contains 0.02-3 wt.% of an additive (Wach: claim 9) wherein the additive is isomalt (Wach: [0065]), which is a sweetener. The additive is added to the trehalulose-containing composition prior to the production of the hard caramel; thus the aqueous medium contains the additive, which is the sweetener as stated above (Wach: [0065]).
Regarding claims 13 and 14, the temperature range of step b) taught by Arenz (130°C or less [0042]) meets the claimed limitation of claim 13 (at most 130ׄ°C) and overlaps with the claimed range of claim 14 (125-135°C). 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). See MPEP 2144.05.I.
Claims 7-9, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wach et al. (US PG Pub 2010/0267658; listed in IDS dated June 8, 2022).
Regarding claims 7 and 12, Wach teaches a hard caramel [0067] containing a trehalulose-containing composition (claims 8 and 15) wherein the aqueous medium contains 92.34 wt.% of the trehalulose-containing composition (based on total dry substance) [0126] and wherein the trehalulose-containing composition comprises 8-50 wt.% isomaltulose (based on dry matter) (claim 7) and 20-95 wt.% trehalulose (based on dry matter) (claim 6). These ranges taught by Wach are the same or lie within the claimed ranges of claim 7.
Wach teaches that the hard candy has a residual water content of 5.88 wt.% (based on total weight) [0126], which is outside of the claimed range of claim 7 of 1.5-3 wt.% as well as the claimed range of claim 12 of 1.9-2.6 wt.%.
However, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Since concentration of a component in a composition is a known variable that affects various properties of the resulting composition, water concentration is a result-effective variable. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range through routine optimization, as varying the residual water content would achieve recognized results. Moreover, generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. See MPEP 2144.05.II. Thus, the parameters of the amount of water content in the hard candy taught by Wach renders obvious the instant claim limitations.
Wach teaches that the trehalulose-containing composition does not crystallize out in the composition (i.e., is not crystalline) [0032].
Wach does not teach that the hard caramel is prepared by a process according to claim 1. However, this is a product-by-process claim, and the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Since the hard caramel taught by Wach is obvious from the product as claimed, the claim limitation is unpatentable.
Regarding claim 8, Wach teaches the hard candy containing 92.34 wt.% (which lies within the claimed range) of the trehalulose-containing composition (based on total dry substance) [0126] comprising 8-50 wt.% isomaltulose (based on dry matter) (claim 7) and 20-95 wt.% trehalulose (based on dry matter) (claim 6). The amounts of isomaltulose and trehalulose taught by Wach encompass the claimed ranges of 15-25 wt.% and 75-85 wt.%, respectively. 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). See MPEP 2144.05.I.
Regarding claim 9, Wach teaches that the composition contains 0.02-3 wt.% of an additive (claim 9) wherein the additive is isomalt [0065], which is a sweetener.
Regarding claim 11, Wach is silent as to that the hard caramel is transparent.
However, when the composition of the prior art is substantially identical to that of the claims, claimed properties or functions are also presumed to be present in the composition of the prior art. Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the hard caramel taught by Wach is substantially identical in composition to the claimed hard caramel, it is presumed that the hard caramel of Wach will also be transparent, thereby rendering obvious the claim.
Response to Arguments
Applicant's arguments filed August 6, 2025 have been fully considered but they are not persuasive.
The prior art rejection has been amended in light of applicant’s amendments to the claims, however, the essential prior art rejection has been maintained by the Examiner for the following reasons.
Applicant’s arguments with respect to claims 1-6, 13, and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that Mergelsberg does not teach the first heating step (step a1) being conducted at atmospheric pressure and that Mergelsberg teaches higher temperatures than claimed in step b of instant claim 1 (remarks, p. 5-8). The new primary prior art reference, Arenz, is now relied upon for heating at atmospheric pressure in step a1 and the temperatures in step b. While Mergelsberg is still used to reject the claims, Mergelsberg is now only used to teach the pressure used in the pressure reduction step (step b). This specific teaching is not challenged in the argument.
Applicant argues that a person of ordinary skill in the art would not combine the process of Mergelsberg with the teachings of Wach (remarks, p. 8). While Wach is still used to teach the trehalulose-containing composition, Arenz, is now used to teach the aqueous medium. Thus, Wach is now modifying Arenz, not Mergelsberg, since Arenz teaches the aqueous medium and Mergelsberg is only used to teach the reduced pressure.
In the absence of any further arguments with regard to the rejections of the additional dependent claims, the rejections of these dependent claims are maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURA E SWEENEY whose telephone number is (571)272-0244. The examiner can normally be reached M-F 8:00-5:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791