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 response to the application filed on April 4, 2024.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-4, 8-11, 13, 18, and 20-23 in the reply filed on March 16, 2026 is acknowledged.
Claims 26, 47, and 49 would be withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. However, applicant has canceled these nonelected claims.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d) with filing dates of January 5, 2022 and August 5, 2022. The respective certified copies of PCT/IB2022/050065 and PCT/IB2022/057310 have been filed in the present application, both received on July 11, 2024.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Application
Claims 1-4, 8-11, 13, 18, 20-23, 26, 47, and 49 were originally presented and subject to a restriction requirement. Claims 76-79 have been newly added. Claims 1-4, 8-11, 13, 18, 20-23, and 76-79 are pending; claims 5-7, 12, 14-17, 19, and 24-75 are canceled. Claims 1-4, 8-11, 13, 18, 20-23, and 76-79 are presented for examination.
Claim Interpretation
Claims 1, 77, and 78 recite that the sweetener particles are “predominantly crystalline.” While “predominantly” is a relative term, the instant specification, on page 168 lines 25-26, defines the term “predominantly,” with respect to crystallinity, as being at least 65 wt.% crystalline. Thus, the claims will be interpreted as such.
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.
Claims 13, 18, and 20-23 are 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.
Claims 13 and 20-23 refer to a percentage without defining the base unit. It is noted that the claim limitation is unclear as to whether the % is based on weight, volume, molar, etc., and as such, the claims fails to distinctly claim the subject matter of the invention and is therefore indefinite. For the purposes of examination, the claim will be interpreted as percent by weight.
Claims 18, 20, and 22 recite the limitation "the food formulation" each in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites “further comprising: a fat, optionally, a starch,” which renders the claim indefinite because it is unclear whether it is the fat or the starch that is optional. For the purposes of examination, the claim will be interpreted such that the starch is optional.
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 and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Arnaudov et al. (US PG Pub. 2012/0121776), herein after referred to as Arnaudov.
Regarding claims 1 and 3, Arnaudov teaches an aerated food composition (i.e., an edible formulation) comprising:
sugar, preferably maltodextrin (i.e., sweetener particles containing a sweetener carbohydrate); and
aggregated protein particles mixed with the sugar/maltodextrin (i.e., a first protein disposed within said sweetener particles) [0079], said first protein being egg white protein [0041];
wherein a weight-to-weight ratio of said first protein to said sweetener within said sweetener particles is within a range of 1:5 to 5:1 (0.2-5%) [0079];
the edible formulation having said sweetener within said sweetener particles being predominantly crystalline (sugar (i.e., sucrose) is a crystalline material).
The weight-to-weight ratio taught by Arnaudov overlaps with the claimed range of 0.02-0.7%. 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 1, 2, 4, 8-10, 13, 18, 20, 21, and 76-79 are rejected under 35 U.S.C. 103 as being unpatentable over Miles et al. (US PG Pub. 2008/0213452), herein after referred to as Miles.
Regarding claims 1 and 2, Miles teaches a sweetener composition (i.e., an edible formulation) comprising:
sweetener particles containing sucrose (i.e., a sweetener carbohydrate) and a sweetener polyol; and
a first protein being vegetable protein isolate;
wherein the protein is in a blend with oligofructose, fructose, and natural flavors, the blend being 1-30 wt.% of the edible composition; the sucrose is 15-65 wt.%, and the polyol is 15-45 wt.% (claim 1); and wherein the blend with the protein is blended with the sucrose and polyol (i.e., a first protein disposed within said sweetener particles) (claim 16);
the edible formulation having said sweetener within said sweetener particles being predominantly crystalline (sucrose and polyols are crystalline materials).
Since Miles is silent as to the amounts of each component in the blend with the protein, it is assumed that each component is contained in an equal amount, each comprising 25 wt.% of the protein blend. Given the amounts of sucrose, polyol, and protein blend taught by Miles, and adding the sucrose and polyol amounts to equal the total sweetener amount, the weight-to-weight ratio of said first protein to said sweetener is 0.0028-0.25%, which overlaps with the claimed range of 0.02-0.7%. 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 4, Miles is silent as to the mucosal adhesion of the edible formulation is greater than that of a control formulation by 3-200%.
However, where the claimed and prior art products are substantially identical in structure or composition, a prima facie case of obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Since the composition of Miles is substantially identical to that of the claimed composition, the prior art product must necessarily possess the same properties and characteristics as the composition claimed. Therefore, the composition taught by Miles is considered to possess the mucosal adhesion as claimed because the composition is substantially the same and thus must necessarily exhibit the same properties.
Claims 8-10 are met through the rejection of claim 1 as set forth above with regard to the structural features of the edible formulation. Claim 1 requires the selection of the sweetener being predominantly crystalline or the mucosal adhesion feature; by selecting the crystalline structural feature to meet claim 1, claims 8-10 are also considered to be met.
Regarding claim 13, Miles teaches that the sweeteners (sucrose and polyol) and first protein (the protein being 25% of the protein blend as set forth above) make up 30.25-117.5 wt.% of the edible formulation (claim 1). This range overlaps with the claimed range of at least 80 wt.%. 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 18, Miles teaches that a baked good comprises the sweetener composition (claim 19), and that the baked good further comprises a fat [0031]; wherein a weight content of the blend of oligofructose, fructose, vegetable protein isolate (i.e., said first protein), and natural flavors is about 1-30 wt.% (claim 1). Since Miles is silent as to the amounts of each component in the blend with the protein, it is assumed that each component is contained in an equal amount, each comprising 25 wt.% of the protein blend. Therefore, the weight content of said first protein is 0.25-7.5%.
The amount of the protein taught by Miles overlaps with the claimed range of 0.01-0.5 wt.%, and 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 claims 20 and 21, Miles teaches a total concentration of sucrose, a polyol, and protein being 30.25-117.5 wt.% (claim 1). Miles is silent as to the amount of fat and does not teach starch and an edible filler in the composition. However, where the taught range already meets the range of claim 20 and overlaps with the range of claim 21, any additional amount of fat would not render the taught range unsatisfactory. 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 76, Miles teaches that the edible formulation is a sweetener composition (i.e., formulation) (claim 1).
Regarding claims 77-79, Miles teaches that the sweetener is sucrose and a polyol, which are both crystalline materials (i.e., predominantly crystalline within a range of 90-100%).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Miles et al. (US PG Pub. 2008/0213452) as evidenced by ADM (“Powerful Polyols: The adaptable, versatile, low-calorie sweetener,” ADM; 2025).
Miles teaches that the sweetener is sucrose and polyols, the polyols such as maltitol, lactitol, sorbitol, mannitol, and xylitol (claims 1 and 2). Miles is silent as to the sweetness on a normalized sweetness scale. However, as evidenced by ADM, sucrose has a sweetness level of 100 and the claimed polyols vary in sweetness, with the lowest being 30 and the highest being 100 (p. 1, table labeled “Sweetness Levels”). On a normalized sweetness scale, these values are 1 and 0.3-1, respectively. Thus, the sweeteners taught by Miles read on the claim limitation.
Claims 1, 18, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Putter et al. (US PG Pub. 2014/0004244), herein after referred to as Putter.
Regarding claims 1, 18, and 20-23, Putter teaches biscuits (i.e., an edible composition) comprising:
a tabletop sweetener (i.e., particles) containing a sugar sweetener (i.e., a sweetener carbohydrate) and a sugar alcohol (i.e., sweetener polyol); and
liquid whole eggs (i.e., a first protein that is egg protein) that is mixed with the sweetener (i.e., a first protein disposed within said sweetener particles) ([0484]; claim 19);
the edible formulating having said sweetener within said sweetener particles being in a crystalline form (i.e., predominantly crystalline) [0038];
wherein the biscuits further comprise shortening (i.e., a fat), flour, cake flour (i.e., a starch), inulin, and wheat fiber (i.e., fillers) [0484].
Putter is silent as to the concentration/amounts of the components of the composition, and is subsequently silent as to the ratio between the protein and the sweetener.
However, 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. 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 a resulting product/composition, this 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 no more than routine optimization, as varying concentration of various ingredients in a composition would achieve recognized results. Thus, the parameters of the amounts of ingredients taught by Putter renders obvious the instant claim limitations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Deininger et al. (US Patent 3,976,800) teaches a food composition wherein protein powder and powdered sweeteners are dispersed together in a mixture (col. 4).
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 9:00-6:00 EST.
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/M.E.S./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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