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 .
Information Disclosure Statement
Applicant is reminded of their duty to disclose all information known to them to be material to patentability as defined in 37 C.F.R. 1.56.
Election/Restrictions
Applicant’s election without traverse of Group I drawn to a semi-solid chewable gel composition in the reply filed on 21 October 2025 is acknowledged.
Claims 24-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 October 2025.
Applicant’s election without traverse of pectin as the species of gelling agent; the combination of allulose, trehalose, isomaltulose, and mannitol as the species of binding composition; resistant maltodextrin as the species of water-soluble polymer stabilizer; and a species of composition further comprising a PED5 inhibitor in the reply filed on 21 October 2025 is acknowledged.
Claims 3-4, 11, 13-18, and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 21 October 2025.
Claims 1, 5, 7-10, and 12 are examined on the merits herein.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities:
Claim 1 recites “wherein the polymer of monosaccharide monomers comprise glucose monomer or mannose monomer linked through glycosidic bonds substantially free of alpha-1,4-glycosidic bond”, which is grammatically unclear. For examination purposes, this is interpreted as “wherein the polymers of monosaccharide monomers comprising glucose monomers or mannose monomers linked through glycosidic bonds are substantially free of alpha-1,4-glycosidic bonds”
In claim 7 line 3, “fruictooligosaccharide” should be “fructooligosaccharide”;
in claim 7 lines 3, “mannan-oligosaccahride” should be “mannan-oligosaccharide”;
in claim 7 line 4, “galacto-oligosaccahride” should be “galacto-oligosaccharide”;
in claim 7 line 4, “fructo-ligosaccharide” should be “fructo-oligosaccharide”;
Claim 7 recites fructooligosaccharide three times in lines 3-4.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 5 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 5 contains the trademark/trade name palatinose. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe isomaltulose and, accordingly, the identification/description is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 recites a semi-solid chewable gel composition which comprises a water-soluble polymer stabilizer. Claim 7 recites the composition of claim 1, wherein the polymer stabilizer comprises cellulose. However, as evidenced by Marinho (Sustainable Chemistry for the Environment, 2025, Vol. 11, 100283), cellulose is insoluble in water (Pg. 1 left column third paragraph). As such, claim 7 fails to include all of the limitations of the claim on which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 5, 7-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wan et al. (WO 2019/241146) in view of Howtian (“Reducing sugar while adding bulk for baked goods, desserts, and confections”) as evidenced by Lu et al. (International Journal of Biological Macromolecules, 2024, Vol. 282, 137124).
Claim 1 is drawn to a semi-solid chewable gel composition, comprising:
a gelling composition in a sufficient amount to provide a cohesive gelled product (more specifically pectin (claim 8, Applicant’s elected species));
a binding composition comprising a sugar, a sugar alcohol, or a combination thereof (more specifically allulose, trehalose, isomaltulose, and mannitol (claim 5, Applicant’s elected species)); and
a water-soluble polymer stabilizer, wherein the polymer stabilizer comprises a polymer of monosaccharide monomers (more specifically resistant maltodextrin (claim 7, Applicant’s elected species)),
wherein the polymer of monosaccharide monomers comprising glucose monomers linked through glycosidic bonds is substantially free of alpha-1,4-glycosidic bonds; the weight ratio of the binding composition and polymer stabilizer is from about 10:1 to 20:1; and the semi-solid chewable gel composition is substantially free of glucose, sucrose, and fructose.
Wan et al. teach low glycemic gummy compositions including a gelling component in a sufficient amount to provide a cohesive gelled product (Abstract). Wan et al. further teach in Example 1 a gummy composition comprising:
pectin;
trehalose, isomaltulose, and sorbitol;
–
water
sodium citrate
coconut oil
raspberry flavor
citric acid
Lakes red food color.
As such, Wan et al. teach a semi-solid chewable gel composition comprising: a gelling composition in a sufficient amount to provide a cohesive gelled product (pectin); a binding composition comprising a sugar, a sugar alcohol, or a combination thereof (trehalose, isomaltulose, and sorbitol); wherein the semi-solid chewable gel composition is substantially free of glucose, sucrose, and fructose.
The semi-solid gel composition of Wan et al. differs from the instantly claimed composition in the following ways:
the composition of Wan et al. does not comprise allulose;
the composition of Wan et al. does not comprise mannitol;
the composition of Wan et al. does not comprise a water-soluble polymer stabilizer;
Wan et al. do not teach the ratio of the binding composition and the polymer stabilizer.
Yet, as to 1: Wan et al. further teach trehalose and isomaltulose as low glycemic index sugar components, further teaching the combination of trehalose, isomaltulose, and psicose (i.e., allulose) as a suitable low glycemic index sugar (Pg. 2 third paragraph). Wan et al. additionally teach in Example 24 (Pg. 36) the combination of allulose, trehalose, and isomaltulose having a suitable sweetness synergy.
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Wan et al. to include allulose. It would have been obvious to substitute the known low GI combination of trehalose, isomaltulose, and allulose in the place of the low GI combination of trehalose and isomaltulose to obtain the predictable result of a gummy composition with suitable sweetness, with a reasonable expectation of success.
As to 2: Wan et al. further teach the gummy composition comprising a plasticizer to modify the texture of the formulation, wherein the plasticizer can include polyols such as sorbitol and mannitol (Pg. 27 third paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Wan et al. to include mannitol. It would have been obvious to substitute one polyol plasticizer suitable for gummy compositions for another to obtain the predictable result of a gummy composition with suitable texture, with a reasonable expectation of success.
As to 3: Wan et al. further teach the gummy composition comprising a bulking agent including polysaccharides of dextrose (pg. 29 third paragraph) additionally teaching resistant maltodextrin as a suitable bulking agent (pg. 9 third paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the composition of Wan et al. to include resistant maltodextrin. It would have been obvious to combine the known gummy composition with the known bulking agent suitable for use in gummy compositions to yield the predictable result of a gummy composition with suitable bulk, with a reasonable expectation for success.
And as evidenced by Lu et al., resistant maltodextrin owes its anti-digestibility to the prevalence of α-1,2, β-1,2, and β-1,6 glycosidic linkages (pg. 1 left column first paragraph), indicating that resistant maltodextrin is substantially free of alpha-1,4-glycosidic bonds.
And, as to 4: Wan et al. teach that the combination of allulose, trehalose, and isomaltulose has significant sweetness (Example 24 on pg. 36), indicating that the amount of allulose, trehalose, and isomaltulose in the composition directly affects the overall taste of the composition.
Wan et al. further teach that the inclusion of a plasticizer modifies the texture of the formula (pg. 27 third paragraph) indicating that the amount of mannitol in the composition directly affects the texture of the composition.
And as taught by Howtian, for producing confections (e.g., gummies) with sugar substitutes including allulose, including a bulking agent to increase the size of the product to be more in line with the expectation of similar products made with sugar (Pg. 1), indicating that the amount of bulking agent in the composition directly affects the size of the product.
As discussed by MPEP 2144.05, “[g]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical” (see also In re Aller (220 F.2d 454)): “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…” Indeed, as further discussed by the court, “[s]uch experimentation is no more than the application of the expected skill of the [ordinarily skilled artisan] and failure to perform such experiments would, in our opinion, show a want of the expected skill”; see also In re Peterson, 315 F.3d at 1325 (Fed. Cir. 2005): “[t]he normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages” and “[o]nly if the ‘results of optimizing a variable’ are ‘unexpectedly good’ can a patent be obtained for the claimed critical range” (quoting In re Antonie (559 F.2d 618 (CCPA 1977))).
In the instant case, the concentrations of allulose, trehalose, and isomaltulose; mannitol; and resistant maltodextrin are clearly result-effective variables, determining the sweetness, texture, and size of the composition, respectively. Accordingly, it would have been customary for an artisan of ordinary skill in the art to determine the optimal concentration of allulose, trehalose, and isomaltulose; mannitol; and resistant maltodextrin in order to best achieve the desired results.
Optimization of the concentrations of allulose, trehalose, isomaltulose, mannitol, and resistant maltodextrin would necessarily result in the optimization of the weight ratio of the binding composition to the polymer stabilizer.
Based on all of the foregoing, claims 1, 5, and 7-8 are rejected as prima facie obvious.
Claim 9 is drawn to the semi-solid chewable gel composition of claim 1, further comprising an active pharmaceutical ingredient (API) composition.
Claim 10 is drawn to the semi-solid chewable gel composition of claim 9, wherein the API composition comprises a PED5 inhibitor (Applicant’s elected species).
Claim 12 is drawn to the semi-solid chewable gel composition of claim 9, wherein the API composition comprises a PED5 inhibitor (Applicant’s elected species).
Wan et al. further teach the gummy compositions comprising an API (pg. 4 second to last paragraph), such as avanafil, tadalafil, sildenafil, or vardenafil (i.e., PED5 inhibitors) (Pg. 8 fourth paragraph).
As such, claims 9-10 and 12 are rejected as prima facie obvious.
Conclusion
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/PAUL HOERNER/Examiner, Art Unit 1611
/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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