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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/19/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 05/19/2026 is acknowledged. Claims 1-15 and 19-20 are cancelled. Claims 16-17 are amended. Claims 16-18 and 21 are the subject of examination on the merits for patentability herein.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Claim Objections
Claim 17 is objected to because of the following informalities: There is an entire blank line 5, which appears to be a simple formatting mistake. Additionally, line 6 is missing the word “wherein” before “the calcium sulfate”. 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 21 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 21 incorrectly depends from Claim 18, referring to Claim 18 as a method claim, however, it is a product claim. As such, it is unclear what Applicant intends to claim in Claim 21. It appears that Claim 21 is intended to depend from Claim 16. Correction is requested.
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.
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 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 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Meyers et al. (US 5,441,749, Of record), hereinafter Meyers.
Meyers teaches a method of making a chewing gum composition comprising the steps of providing and mixing a gum base with bulking and sweetening agent, flavor, and calcium sulfate (Abstract; Claim 13).
Regarding Claims 16-17, Meyers teaches the use of calcium sulfate in food products as a nutrient, firming agent etc. as well as a pigment (Col. 2, lines 16-32). Meyers recognizes that calcium sulfate comes in an anhydrous form, gypsum, calcium sulfate dihydrate, existing as fine, white to yellow-white powder (Col. 2, lines 16-23). Calcium sulfate anhydrous may also act as a desiccant to prevent moisture from the atmosphere from affecting chewing gum products (Col. 6, lines 31-34). Meyers teaches the chewing gum composition wherein the calcium sulfate has a particle size of less than about 75 microns (Claim 2; Col. 2, lines 33-36). Meyers teaches calcium sulfate as an ingredient in chewing gum at about 0.2%-6% calcium sulfate, and expressly teaches the gypsum form at 2.5%-6% , overlapping with the claimed amounts (Examples 1-5; Claims 1 and 4). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05.
It would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use calcium sulfate anhydrous, as the calcium sulfate form in the chewing gum under humid conditions the product would benefit from having a desiccant to prevent moisture from the atmosphere to affect the chewing gum products.
Regarding the role as a pigment, Meyers teaches recognizes calcium sulfate as a pigment, which the instant claim and specification also notes for imparting white color (p. 20, line 1), Meyers therefore renders obvious the feature of the claim that calcium sulfate anhydrite imparts a white color to the foodstuff etc. and colors the foodstuff as it is an inherent property. Because the prior art composition is the identical composition claimed, the composition must necessarily have the characteristics claimed in Claims 16 and 17. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
The calcium sulfate weight of 1-4%, and particle size of less than 75 microns taught by Meyers overlap with the instantly claimed ranges. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05. While Meyers does not state the mean particle size (d[4,3]) is from 1.0 to 5.0 µm and a median particle size (D50) in the range of greater than or equal to 0.5 µm to less than or equal to 5 µm, an improvement in the art would have been obvious if “it is likely the product not of innovation but of ordinary skill and common sense.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007). Finding workable or optimal ranges is generally understood as within the capabilities of the ordinary artisan. See Pfizer Inc. v. Apotex Inc., 82 USPQ2d 1321 (Fed. Cir. 2007) (discovery of an optimum value of a variable in a known process is usually obvious.). As such, one of ordinary skill in the art would find it obvious to adjust the amount and mean/median particle size as a matter of experimentation and optimization. The adjustment of particular conventional working conditions is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. In re Antonie, 559 F.2d 618, 620, 195 USPQ 6, 8 (CCPA 1977); see also In re Dillon , 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed.Cir. 1990) (in banc).” Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
Regarding Claims 18 and 21, Meyers teaches chewing gum product, which the Examiner is encompassed by foodstuff (Abstract; Claim 1).
Claims 16-18 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Meyers in view of Prencipe et al. (EP 2249788B1), hereinafter Prencipe.
In the event that Meyers is not found to satisfactorily render obvious the instant invention due to the particle size, the claims are still obvious over Meyers in view of Prencipe.
The teachings of Meyers have been set forth supra.
Meyers teaches the calcium sulfate has a particle size of less than about 75 microns, which overlaps with the mean and median particle size. Meyers also teaches that the calcium sulfate in the chewing gum composition has an average size of about 14 microns, which may be deemed higher than the claimed range (Claim 2; Col. 2, lines 33-36).
Prencipe is in a related field, and teaches oral care compositions inter alia chewing gum form [0099]. Prencipe teaches compositions comprising an abrasive or particulate such as silica, calcium carbonate, calcium sulfate etc. (p. 6, line 1.0.36). The abrasive material including a small particle fraction comprising at least 5 wt% of the total composition weight, wherein the particles of the small particle fraction have a d50 of less than 5 µm (Claim 8). Further, Prencipe recognizes that precipitated silica having a median particle diameter d50 of less than 3µm and a d90 value of 6mm or less has controlled abrasivity and effective cleaning properties useful in oral compositions [0006]. Prencipe further teaches that small particles are particularly useful in formulations targeted at reducing hypersensitivity [0053].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Prencipe to the teachings of Meyers, and use smaller size particles of calcium sulfate in chewing gum formulations that are aimed at a population with hypersensitivity. One skilled in the art would start with particles having particle size d50 of less than 5 µm, and median diameter of d50 of less than 3µm to ensure controlled abrasivity and effective cleaning, and optimize the size of the particle depending on the need to reduce hypersensitivity while maintaining the abrasivity and cleaning efficiency.
Response to Arguments:
Applicant traverses the rejection over Monzyk in view of Meyers, alleging that the combination does not teach or suggest calcium sulfate anhydrite pigment imparts a white color to the foodstuff, nutritional supplement, cosmetic product, or pharmaceutical product. Applicant specifically argues that the amended claim recite that calcium sulfate anhydrite pigment as imparting the white color and not merely bleaching or whitening the substrate, which is what Monzyk does. Applicant also argues that Monzyk is not analogous art.
Applicant’s argument was considered by the Examiner but found moot. Upon consideration of the amendment, the Examiner deemed Meyers to be a closer prior art for the amended claims. The rejection supra does not rely on Monzyk for any teaching.
Applicant then argues that Meyers does not cure these deficiencies of Monzyk because Meyers is directed to chewing gum products using calcium sulfate as a filler and as a rolling compound, and not as a pigment that imparts a white color to the chewing gum product. Applicant admits that Meyers states that calcium sulfate "is sometimes used in food products as a pigment," but argues that its use is limited at low levels as pigment in food products, whereas calcium sulfate is "typically used at higher levels" as a filler or rolling compound in chewing gum.
The Examiner has weighed the argument but found it unpersuasive. Applicant appears to assign a narrow skill set to one of ordinary skill in the art. Contrary to this, it is well within the skills of one of ordinary skill in the art to adjust the amount, beginning with the range taught by Meyers and optimizing upwards or downwards in concentration depending on the desired pigmentation intensity, regardless of the intended use of the prior art. Adjusting the amount is a matter of experimentation and optimization, and is what researchers do. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Applicant further argues that Meyers expressly identifies gypsum, i.e., calcium sulfate dihydrate, as preferred for use in its invention, not the anhydrous form. Applicant points to the examples in Meyers referring to gypsum as the filler and rolling compound, and that calcium sulfate anhydrite can act as a drying or anti-condensation agent to prevent the influence of atmospheric moisture on chewing gum products, but that the rolling agent is not part of the chewing gum product.
This argument is also not persuasive. A preferred or exemplified embodiment does not constitute a teaching away from other embodiments disclosed within the four corners of the reference, including non-preferred embodiments. Applicant is reminded that the disclosure of a reference must be considered as expansively as is reasonably possible to determine the full scope of the disclosure and, as a result, is most certainly most not limited to that which is preferred and/or exemplified. Thus, the fact that other calcium sulfate forms may be preferred or exemplified does not negate or direct the artisan away from the broader teaching of the reference, which expressly provides for, and, thus, clearly contemplates the use of calcium sulfate anhydrous in a food composition as instantly claimed. It is well within the skill of an ordinary artisan to use the anhydrous form under conditions where a dessicating form would be more useful.
Contrary to Applicant’s allegation that the calcium sulfate anhydrite is not part of the chewing gum composition of Meyers, the reference expressly recite that “Calcium sulfate anhydrous may act as a desiccant to prevent moisture from the atmosphere from affecting chewing gum products”, and goes on to say that “In addition to, or alternative to, applying the calcium sulfate to the gum, the calcium sulfate may be used inside the packaging material”, which clearly contemplates the inclusion of the calcium sulfate anhydrite in the chewing gum composition.
Importantly, the recitation of “wherein the calcium sulfate anhydrite pigment imparts a white color to the foodstuff, nutritional supplement, cosmetic product, or pharmaceutical product”, is not given patentable weight. "A 'whereby' clause that merely states the result of the limitations in the claim adds nothing to the patentability or substance of the claim." Texas Instruments, Inc. v. International Trade Comm., 988 F.2d 1165, 1172 (Fed._Cir. 1993). See also Minton v. National Assoc. of Securities Dealers, Inc., 336 F.3d 1373, 1381 (Fed. Cir. 2003) ("A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited."). Note MPEP 2111.04. In this case, claim 1 uses the term "wherein", rather than "whereby", but it is concluded that the terms should be treated the same ... the wherein clause does not inform the artisan of how the mixing steps are performed; rather, the wherein clause merely characterizes the results of those steps and does not distinguish the instantly claimed application from the application taught in the prior art.
Applicant argues that Meyers does not teach the claimed particle-size requirements for a calcium sulfate pigment, but rather discloses calcium sulfate having a particle size of less than about 75 microns, more preferably an average particle size of about 14 microns with respect to its functionality of the rolling agent.
Meyers teaches a range of “less than about 75 microns” that overlaps with the claimed range. As above, it is well within the skills of one of ordinary skill in the art to adjust the particle size, beginning with the range taught by Meyers and optimizing the size as a matter of experimentation and optimization. Only if the “results of optimizing a variable” are “unexpectedly good” can a patent be obtained for the claimed critical range. Note MPEP §2144.05(II)(A) on this issue. Likewise, optimization of a range or other variable within the claims flows from the “normal desire of scientists or artisans to improve upon what is already generally known.” In re Peterson, 65 USPQ2d 1379, 1382.
Note that this applies even if the prior art range is very broad, and would apply to Meyers range of “less than about 75 microns”. In In re Waymouth and Koury, 182 USPQ 290, the prior art range was 0.0000001 to 1.3 (called “extremely broad”); the claims were 0.08 to 0.75. The court stated, “In order to show an unexpected result, we do not believe that the lamp must be inoperable over other ranges, but rather that over the claimed critical range, there be a difference in kind, rather than in degree.” To overcome this prima facie case of obviousness applicants must show that the claimed range achieves unexpected results relative to the prior art range. This showing must be commensurate in scope with the claimed range or, in other words, an applicant must show that the unexpected result occurs throughout the entire claimed range. See In re Harris, 74 USPQ2d 1951 in MPEP §2144.05 (I). The showing must also present enough data points within the prior art range, but outside the claimed range, to establish that the unexpected property does not occur outside the claimed range. In re Hill, 284 F.2d 955, 958-59 (CCPA 1960). See MPEP §716.02(d)(II).
Additionally, the second rejection section supra combines the teachings of Prencipe to Meyers, showing that the particle size of calcium sulfate in chewing gums are known.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
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/JANICE Y SILVERMAN/Examiner, Art Unit 1792
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