FINAL 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 .
Status of the Claims
This action is in response to papers filed 01/28/2026 in which claims 1-99, 101, 111, 113, and 121-124 were canceled; and claims 100, 125, and 126 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 100, 102-110, 112, 114-120, and 125-127 are under examination.
Withdrawn Objections/Rejections
The Examiner has re-weighted all the evidence of record. Any rejection and/or objection not specifically addressed below is hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Maintained-Modified Rejections
Claim Rejections - 35 USC § 112 – NEW MATTER
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 125-127 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 125 and 126 introduce new matter as the claims recite the limitations: “non-directly compressible particles of dextrate” as recited in claim 125 and “non-directly compressible particles of dextrose” as recited in claim 126; There is no support in the specification for the aforementioned limitations.
Applicant asserted that the support for the amendments can be found, at least at paragraphs [0053] and [0056] of the present application (specification).
However, after a thorough review of said paragraphs [0053] and [0056], as well as, throughout the specification, there appears to be no support for the claimed limitations of: “non-directly compressible particles of dextrate” as recited in claim 125 and “non-directly compressible particles of dextrose” as recited in claim 126.
Below are the disclosures from paragraphs [0053] and [0056] of the specification:
[0053] In some embodiments of the invention, the dextrose comprises a purified mixture of saccharides. In some embodiments of the invention, the dextrose comprises oligomeric saccharides. In some embodiments of the invention, the dextrose comprises 93 to 97% dextrose equivalents calculated on a dry basis. In some embodiments of the invention, the dextrose comprises microcrystalline dextrose. In some embodiments of the invention, the dextrose comprises dextrate.
[0056] In some embodiments of the invention, the dextrose is directly compressible (DC). [0057] In some embodiments of the invention, the dextrose is a powder. [0058] In some embodiments of the invention, the dextrose comprises at least 30% by weight of particles in the range of 100 to 500 microns.
As shown above, neither paragraph [0053] nor paragraph [0056] provide support for the claimed limitations: : “non-directly compressible particles of dextrate” as recited in claim 125 and “non-directly compressible particles of dextrose” as recited in claim 126;
Nowhere in paragraph [0053] or paragraph [0056] does it disclose the dextrose particles are “non-directly compressible” nor is “non-directly compressible” positively recited in alternative form as it pertain to dextrose particles or dextrate particles. Thus, paragraphs [0053] and [0056] do not provide support for the particles dextrose or dextrate to be “non-directly compressible”.
Applicant is noted that any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977). If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). The mere absence of a positive recitation is not basis for an exclusion.
Claim 127 is also rejected as they depend from claim 126, thereby also containing the new matter material.
As such, the disclosure does not reasonably convey that the inventor had possession of the subject matter of claims 125 and 126 as amended at the time of filing of the instant application.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant’s arguments in the Remarks filed 01/28/2026 relied on the Declaration from Jesper Neergaard (hereafter as “Neergaard Declaration”), submitted on 01/28/2026 as the rebuttal for obviating the new matter rejection. Thus, Applicant’s arguments in view of the Neergaard Declaration will be addressed together as set forth below.
Applicant argues:
“the wording "non-directly compressible particles of dextrose" as applied in claims 100, 125 and 126, contrary to the allegations from the Office Action, is already directly and unambiguously disclosed in the application as filed and is even directly apparent from the instantly claimed invention. While the Office Action solely refers to paragraphs [0053], [0056] and [0057] for basis to this wording, Dr. Neergaard notes that the claims already include a selection of specific non-directly compressible particles of dextrose, i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate. Since the wording "non-directly compressible particles of dextrose" exclusively relates to these selected species and since these species are ALL "non-directly compressible" BY NATURE (as also confirmed by the previously cited document to Brys), it can only be concluded that the relevant wording finds suitable basis in the application as filed according to Dr. Neergaard. In other words, according to Dr. Neergaard, the wording "non-directly compressible particles of dextrose" does not add matter since the selected species instantly claimed are non-directly compressible BY NATURE, and the wording therefore does not add more than the selected species themselves. Neergaard Declaration, ¶5.
Specifically, according to Dr. Neergaard, the wording "non-directly compressible particles of dextrose" relates to the inherent nature of the recited particles of dextrose as being "non-directly compressible" in claims 100, 125 and 126. Since the recited species of dextrose (namely anhydrous dextrose, hydrated dextrose, and dextrose monohydrate) are all non-directly compressible by nature, and since it is expressly recited that these particles are not granules in the compressed powder blend (separate from the one or more active ingredients), it is evident that the instant chewable tablet is formed by compression of non-directly compressible dextrose according to Dr. Neergaard. Neergaard Declaration, ¶6.”
In response, the Examiner disagrees. The “Jesper Neergaard” (hereafter as “Neergaard Declaration”) under 37 C.F.R. §1.132 filed 01/28/2026 is considered, but found insufficient to overcome the 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph (New Matter), as set forth in this office action for the reasons set forth below.
While the species of “anhydrous dextrose,” “hydrated dextrose,” and “dextrose monohydrate” as recited in the Markush group of claim 100 are considered non-directly compressible dextrose particles, these species are not recited in claims 125 and 126, which is directed to generically “non-directly compressible particles of dextrate” and “non-directly compressible particles of dextrose,” respectively. Applicant’s Neergaard Declaration mainly focused on the species of “anhydrous dextrose,” “hydrated dextrose,” and “dextrose monohydrate” as inherent by nature being non-directly compressible. However, this Declaration cannot be extended to the genus of “non-directly compressible particles of dextrose” as recited in claim 126, much less the genus “non-directly compressible particles of dextrate” as recited in claim 125. There is no factual/objective evidence in the Neergaard Declaration that the genus of “particles of dextrose” or “particles of dextrate” are “non-directly compressible.” As discussed above in the standing New Matter rejection, paragraph [0056] of the specification particularly disclosed the dextrose is directly compressible (DC). Thus, as discussed in the standing New Matter rejection, it is maintained that neither paragraph [0053] nor paragraph [0056] provide support for the claimed limitations: : “non-directly compressible particles of dextrate” as recited in claim 125 and “non-directly compressible particles of dextrose” as recited in claim 126;
It is reiterated that [n]owhere in paragraph [0053] or paragraph [0056] does it disclose the dextrose particles are “non-directly compressible” nor is “non-directly compressible” positively recited in alternative form as it pertain to dextrose particles or dextrate particles. Thus, paragraphs [0053] and [0056] do not provide support for the particles dextrose or dextrate to be “non-directly compressible”.
Applicant is reiterated that any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977). If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). The mere absence of a positive recitation is not basis for an exclusion.
As a result, for at least the reason discussed above, it is maintained that the disclosure does not reasonably convey that the inventor had possession of the subject matter of claims 125 and 126 as amended at the time of filing of the instant application.
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.
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.
Claim(s) 100, 102-110, 112, 114-116, 119, and 125-127 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US 6,270,790 B1) in view of Haslam et al (US 2005/0079135 A1) and Wittorff (US 2018/0140554 A1), and as evidenced by Ingredion™ (“Technical Specification: CERELOSE® Coarse Dextrose 020330”. Retrieved online on 4 June 2025).
Regarding claims 100, 125, and 126, Robinson teaches a soft chewable tablet comprising a compressible carbohydrate such as dextrose, at least one active ingredient, and a binder, wherein the chewable tablet contains the compressible carbohydrate in an amount of about 30 to about 90% by weight, the binder in an amount of about 1 to 30% by weight, and active ingredient in an amount from about 0.1 to about 60% by weight (Abstract; column 1, lines 49-end; column 2; columns 5-10; claims 1-8). Robinson teaches dextrose as one of the preferred compressible carbohydrates (column 2, lines 32-42; claim 1). Robinson teaches the chewable tablet was prepared by dry blending, the active ingredient, the compressible carbohydrate and binder, and then compressing into a convex shaped tablet (Abstract; columns 1-2 and 5-6), thereby the active ingredient and the binder are separate components or ingredients from the compressible carbohydrate (dextrose) in the dry blend (powder blend) or in other words, the active ingredient and the binder were separately added during the formulation of the chewable tablet.
With respect to the particles of dextrose be selected from the group consisting of particles of anhydrous dextrose, hydrated dextrose, dextrose monohydrate, and combinations thereof as recited in claim 100 and the particles of dextrate as recited in claim 125, Haslam teaches a chewable tablet comprising an active ingredient (lanthanum), dextrate or dextrose, and binder, wherein lanthanum, dextrate or dextrose, and binder are in powder form (Abstract; [0005], [0026]-[0029], [0045], [0047]-[0050]; claims 1 and 18-23). Haslam teaches that the dextrose is from the commercially available dextrose brand of Cerelose® ([0046]-[0048]; claims 19-21). As evidenced by Ingredion™, Cerelose® dextrose as taught in Haslam is monohydrate dextrose product (page 1).
It would have been obvious to one of ordinary skill in the art to incorporate dextrose monohydrate or dextrate as the dextrose in the chewable tablet of Robinson, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Haslam provided the guidance to do so by teaching that dextrate or dextrose (particularly dextrose monohydrate) can be used as the direct compressible excipient in the forming the chewable tablet that has a desired palatability and compressibility (cohesiveness) (Haslam: [0005], [0025] and [0035]), which are also the objectives of chewable tablet of Robinson (columns 1-2 and 5-6). Thus, an ordinary artisan would have looked to other known sources of dextrose binders including dextrate or dextrose monohydrate of Haslam to be used as the dextrose component in the chewable tablet of Robinson so as to produce a desired chewable tablet that is palatable, and achieve Applicant’s claimed invention with reasonable expectation of success.
It would also have been obvious to one of ordinary skill in the art to optimize the weight amount of dextrose or dextrate, active ingredient, and binder in the chewable tablet of Robinson to the weight amounts as claimed, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Robinson teaches the chewable tablet contains the compressible carbohydrate (dextrose) in an amount of about 30 to about 90% by weight, the binder in an amount of about 1 to 30% by weight, and active ingredient in an amount from about 0.1 to about 60% by weight, which are ranges that overlaps the claimed ranges for dextrose, active ingredient, and binder. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the weight amounts of dextrose particles, active ingredient, and binder in a chewable tablet would have been obvious before the effective filing date of applicant's invention. “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 (I)-(II).
With respect to the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” as recited in claims 100, 125, and 126, respectively, it is noted that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With respect to the claimed “non-directly compressible active ingredient,” it is noted that “non-directly compressible” as recited in claims 100, 125, and 126 is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “active ingredient.” It is noted that the active ingredient of Robinson is not structurally different from the claimed “active ingredient” and thus, “non-directly compressible” or “direct-compressible” characteristic feature does not change the structure of the “active ingredient,” as structure of the “active ingredient” of Robinson is the same as the structure of claimed “active ingredient”. Thus, there is no structure difference between the “active ingredient” of Robinson and that of the claimed “active ingredient”. As discussed above, "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
With respect the claimed “said binders is selected from the group consisting of hydroxypropyl cellulose (HPC), hydroxypropyl methylcellulose (HPMC), and combinations thereof” as recited in claims 100, 125, and 126, Wittorff teaches a chewable compressed tablet comprising one or more cellulose binders selected from hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), or a combination thereof (Abstract; [0006]-[0025], [0109]-[0111]; claims 1-7).
It would have been obvious to one of ordinary skill in the art to incorporate hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), or a combination thereof as the binder in the tablet of Robinson in view of Haslam, and produced the claimed invention. One of ordinary skill in the art would have been motivated to do so because as discussed above, Wittorff provided the guidance to do so by teaching hydroxypropyl cellulose (HPC) and hydroxypropylmethylcellulose (HPMC) are known binders suitable use in tableting chewable compressed tablet. One of ordinary skill in the art would have reasonable expectation of success in incorporating hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), or a combination thereof as the binder in the tablet of Robinson in view of Haslam because Robinson indicated that cellulose and cellulosic derivatives are suitable for use as the binder in forming the chewable tablet (Robinson: column 2, lines 43-54; claim 1), and the hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), or a combination thereof as taught in Wittorff is within the scope of the cellulose and cellulosic derivatives of Robinson. Thus, an ordinary artisan would have look to selecting known binders in the art including hydroxypropyl cellulose (HPC), hydroxypropylmethylcellulose (HPMC), or a combination thereof and use it as the binder in the tablet of Robinson in view of Haslam, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claims 102 and 103, as discussed above, Robinson teaches the chewable tablet contains compressible carbohydrate such as dextrose in an amount of about 30 to about 90% by weight and binder in an amount of about 1 to 30% by weight, and such resultant chewable tablet has improvements in mouthfeel and ease of chewing (Robinson: column 1, lines 49-end; column 5, lines 35-end). It is noted that the amount of compressible carbohydrate such as dextrose relative to the amount of binder as guided in Robinson overlap the ratio of dextrose to binder from 1:250 to 1:25 and 1:100 to 1:8, respective of claims 102 and 103. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the ratio of dextrose to binder in a chewable tablet would have been obvious before the effective filing date of applicant's invention. “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 (I)-(II).
Regarding claim 104, as discussed above, Robinson teaches the chewable tablet contains binder in an amount of about 1 to 30% by weight, and active ingredient in an amount from about 0.1 to about 60% by weight, which overlaps the claimed ratio of binder to active ingredient from 1:75 to 1:8 of the claimed invention. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the ratio of binder to active ingredient in a chewable tablet would have been obvious before the effective filing date of applicant's invention. “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 (I)-(II).
Regarding claim 105, as discussed above, Robinson teaches the chewable tablet contains compressible carbohydrate such as dextrose in an amount of about 30 to about 90% by weight, which overlaps the claimed range of “from 70 to 95% by weight.” Thus, as discussed above, the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. Absent some demonstration of unexpected results from the claimed parameters, the optimization of weight amount of dextrose in a chewable tablet would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claim 106, Robinson teaches and provide guidance for formulating a chewable tablet that contains compressible carbohydrate such as dextrose, active ingredient, binders and adjuvants such as lubricant, sweetener, flavors and color, wherein the adjuvants are present in amount of up to about 5% by weight of chewable tablet (column 5).
Regarding claims 107 and 108, as discussed above, Robinson teaches the compressible carbohydrate is dextrose. As discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose®) as the dextrose in the formation of the chewable tablet. As evidenced by Ingredion™, the dextrose monohydrate has minimum dextrose equivalent of 99.5% (page 1, under “Chemical and Physical Properties”). Thus, the use of dextrose monohydrate of Haslam as the dextrose in the formation of chewable tablet of Robinson per guidance from Haslam, meets the claimed “said dextrose comprises at least 90% dextrose equivalents calculated on a dry basis” of claim 107 and “said dextrose comprises 100% dextrose equivalents calculated on a dry basis” of claim 108.
Regarding claims 109 and 110, as discussed above, Robinson teaches the compressible carbohydrate is dextrose. As discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose®) as the dextrose in the formation of the chewable tablet. As evidenced by Ingredion™, the majority of the dextrose particles in dextrose monohydrate (Cerelose®) have particle size of less than 200 microns (page 1, under “Screen Test”).
Regarding claims 112 and 127, as discussed above, Wittorff teaches and provided guidance for using hydroxypropyl cellulose (HPC) as the binder in the tablet of Robinson in view of Haslam. Thus, an ordinary artisan would have look to selecting known binders in the art including hydroxypropyl cellulose (HPC) and use it as the binder in the tablet of Robinson in view of Haslam, and achieve Applicant’s claimed invention with reasonable expectation of success.
Regarding claims 114-116, Robinson teach vitamins and pharmaceuticals as suitable active ingredients (Robinson: column 2, lines 54-end).
Regarding claim 119, Robinson teaches that the active ingredient can be in the chewable tablet in a dosage amount from 0.5 to 600 mg (column 5, lines 35-50), which overlaps the claimed dosage amount of 1 to 1000 mg. Thus, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see 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); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985). Absent some demonstration of unexpected results from the claimed parameters, the optimization of the amount of binder in a chewable tablet would have been obvious before the effective filing date of applicant's invention. “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 (I)-(II).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 117 and 118 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US 6,270,790 B1) in view of Haslam et al (US 2005/0079135 A1) and Wittorff (US 2018/0140554 A1), and as evidenced by Ingredion™ (“Technical Specification: CERELOSE® Coarse Dextrose 020330”. Retrieved online on 4 June 2025), as applied to claim 100 above, and further in view of Venkatesh et al (US 2012/0282335 A1).
The oral chewable tablet of claim 100 is discussed above, said discussion being incorporated herein in its entirety.
However, Robinson, Haslam, and Wittorff do not teach the oral chewable tablet comprises one or more disintegrants operable to disintegrate the tablet within a period of 2 minutes or less in contact with oral saliva of claim 117; and the disintegrant of claim 118.
Regarding claims 117 and 118, Venkatesh teaches a compressed tablet comprising a saccharide such as dextrose, at least one super disintegrant such as crospovidone, and a pharmaceutically acceptable additive such as a binder, wherein the tablet disintegrate within 60 seconds (Abstract; [0026]-[0034], [0045], [0048], [0059]-[0063]).
It would have been obvious to one of ordinary skill in the art to include disintegrant such as crospovidone in the tablet of Robinson in view of Haslam and Wittorff so as to obtain a tablet which disintegrate within a period of 2 minutes or less, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Venkatesh provided the guidance to do by teaching that a tablet containing saccharide such as dextrose and binder such as those of Robinson in view of Haslam and Wittorff, can further contain a disintegrant so as to obtain a tablet disintegrate within 60 seconds, a disintegrating time which meets the claimed within a period of 2 minutes or less in contact with oral saliva. Thus, an ordinary artisan seeking to provide a tablet which disintegrate within a period of 2 minutes or less, would have looked to including disintegrant such as crospovidone to the tablet of Robinson in view of Haslam and Wittorff, achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 120 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al (US 6,270,790 B1) in view of Haslam et al (US 2005/0079135 A1) and Wittorff (US 2018/0140554 A1), and as evidenced by Ingredion™ (“Technical Specification: CERELOSE® Coarse Dextrose 020330”. Retrieved online on 4 June 2025), as applied to claim 100 above, and further in view of Andersen et al (US 2010/0189768 A1).
The oral chewable tablet of claim 100 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 120, Andersen teaches a compressed chewing gum tablet comprising two modules containing a first compressed module comprising a gum base and a second compressed module containing an active ingredient, a taste-masking agent such as dextrose, and a binder, wherein the compressed chewing gum tablet effectively mask the unpleasant taste of the active ingredient upon chewing the tablet (Abstract; [0014]-[0090], [0187]-[0191], and [0210]-[0244]; Example 3).
It would have been obvious to one of ordinary skill in the art to formulate the chewable tablet of Robinson in view of Haslam and Wittorff into a compressed chewing gum tablet by compressing another module containing a gum to the compressed module containing an active ingredient, dextrose and binder, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Andersen provided the guidance to do by teaching that the chewable tablet of Andersen can be modified from a one module chewable tablet to a two-module chewable tablet in which the module containing active ingredient, dextrose and binder of Robinson and Haslam can be compressed with a second module containing a gum base, and such resultant two-modules chewable tablet effectively mask the unpleasant taste of the active ingredient upon chewing the tablet. Thus, an ordinary artisan seeking to formulate a chewable tablet that effectively masks the bitter taste of an active ingredient would looked to formulating the chewable tablet of Robinson in view of Haslam and Wittorff into a compressed two-module chewable tablet per guidance from Andersen, and achieve Applicant’s claimed invention with reasonable expectation of success.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of Applicant’s invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant’s arguments in the Remarks filed 01/28/2026 relied on the Declaration from Jesper Neergaard, submitted on 01/28/2026 as the rebuttal for nonobviousness. Thus, Applicant’s arguments in view of the Neergaard Declaration will be addressed together as set forth below.
The “Jesper Neergaard” (hereafter as “Neergaard Declaration”) under 37 C.F.R. §1.132 filed 01/28/2026 is considered, but found insufficient to overcome the 103 rejections as set forth in this office action for the reasons set forth below.
Applicant argues:
“[a]s noted above, according to Dr. Neergaard, the wording "non-directly compressible particles of dextrose" relates to the inherent nature of the recited particles of dextrose as being "non-directly compressible" in claims 100, 125 and 126. Since the recited species of dextrose (namely anhydrous dextrose, hydrated dextrose, and dextrose monohydrate) are all non-directly compressible by nature, and since it is expressly recited that these particles are not granules in the compressed powder blend (separate from the one or more active ingredients), it is evident that the instant chewable tablet is formed by compression of non-directly compressible dextrose according to Dr. Neergaard. This is not the case for the dextrose in Robinson. Robinson solely applies compressible dextrose as a mandatory element (see claim 1 of Robinson). And since the claimed invention is all about non-directly compressible dextrose, Dr. Neergaard would find no motivation to consider Robinson (applied in all rejections for non-obviousness), inherently stating that compressible dextrose is mandatory, in combination with the cited prior art documents presented by the Office Action. Neergaard Declaration, ¶6
Accordingly, as a person skilled in the art, Dr. Neergaard can only see the wording "non- directly compressible particles of dextrose" as being fully in scope with the nature of the selected and claimed non-directly compressible dextrose species, and would find no motivation in Robinson (also not in combination with the remaining cited prior art) to come to the instantly claimed invention based on this element of non-directly compressible dextrose in isolation. Neergaard Declaration, ¶7” (Remarks, page 9).
In response, the Examiner disagrees. “compressible carbohydrate” as disclosed in Robinson does not mean the carbohydrate such as dextrose is “directly compressible”. The terms “compressible” and “directly compressible” are not the same. There is no indication in Robinson, the carbohydrate such as dextrose is “directly compressible” and this is evident by claim 1, which also recites that the compressed chewable tablet contains a binder, thereby the ”compressible carbohydrate” such as dextrose is not “directly compressible.” Furthermore, as discussed in the standing 103 rejection, Haslam provided the guidance for using dextrose monohydrate as the dextrose in the chewable tablet of Robinson (see 103 rejection, pages 9-12 of this office action). Dextrose monohydrate as taught by Haslam meets the claimed “non-directly compressible particles of dextrose” as recited in claim 100, which is also evident by the Neergaard Declaration, which had declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6). Accordingly, the combined teachings of Robinson, Haslam, and Wittorff (and as evidenced by Ingredion) remained to render obvious Applicant’s claimed invention.
Applicant argues:
“one cannot just allege that "non-directly compressible" has no structure (or limitation) according to Dr. Neergaard. If a component is claimed to be "non-directly compressible," this would mean that there must be an inherent structural arrangement that makes it "non-directly compressible" in the same way as it would incur a structural arrangement to make it "directly compressible" according to Dr. Neergaard. For instance, CERELOSE® Coarse Dextrose 020330 (explicitly referenced by the Office Action) is specifically designed by the manufactures to be "directly compressible" by means of coarse particles with a rounded, porous particle shape. Under features and benefits in the document, CERELOSE® Coarse Dextrose 020330 is mentioned to be "very compressible." Hence, the Office Action cannot allege that the term "non-directly compressible" is not structure limiting, when the Office Action itself refers to CERELOSE® Coarse Dextrose 020330 that indeed is structure limiting (directly compressible) and specifically designed to be so according to Dr. Neergaard. Neergaard Declaration, ¶10” (Remarks, page 10).
In response, the Examiner disagrees. While instant claim 100 provided structure to the “non-directly compressible particles of dextrose” by reciting a Markush group of alternative species (i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate), claim 125 and 126, in contrast, do not provide any limiting structure to the claimed “non-directly compressible particles of dextrose” of claim 126 and “non-directly compressible particles of dextrate” of claim 125. Furthermore, as discussed above and in the 103 rejection, CERELOSE® Coarse Dextrose 020330 of Haslam is a dextrose monohydrate per Ingredion. As discussed above, The Neergaard Declaration declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6), which contradicts the latter assertion in Neergaard Declaration which asserted that the CERELOSE® Coarse Dextrose 020330 is “very compressible” or “directly compressible.” How can the structurally same “dextrose monohydrate” of Haslam and the claimed invention be both “non-directly compressible” and “directly compressible” as declared by Neergaard Declaration? Thus, the assertions in the Neergaard Declaration are contradictory.
Accordingly, as previously discussed and in the standing 103 rejection, it is maintained that that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Applicant argues:
“since the Office Action applies CERELOSE® Coarse Dextrose 020330 as evidence of dextrose monohydrate allegedly applied by Haslam, the Office Action has not met the burden of providing a reasonable argumentation for rejecting claims 100, 102-110, 114-116, 118, and 125- 126 according to Dr. Neergaard. The Office Action appears to allege that Haslam provides the guidance for using dextrose monohydrate in the formation of the chewable tablet of Robinson. However, since CERELOSE® Coarse Dextrose 020330 is "directly compressible," the Office Action has not identified any "non-directly compressible" particles of dextrose in the combined prior art. The argument from the Office Action that Haslam meets the requirement of "non-directly compressible particles of dextrose" does not hold, since CERELOSE® Coarse Dextrose 020330 is directly compressible. Also, no direct reference is made in Haslam to CERELOSE® Coarse Dextrose 020330, let alone to dextrose monohydrate, but only to "dextrose" in general and "Cerelose" as an example of what this "dextrose" may be. Neergaard Declaration, ¶11” (Remarks, page 10, last paragraph to page 11).
In response, the Examiner disagrees. As discussed above, while instant claim 100 provided structure to the “non-directly compressible particles of dextrose” by reciting a Markush group of alternative species (i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate), claim 125 and 126, in contrast, do not provide any limiting structure to the claimed “non-directly compressible particles of dextrose” of claim 126 and “non-directly compressible particles of dextrate” of claim 125. Furthermore, as discussed above and in the 103 rejection, CERELOSE® Coarse Dextrose 020330 of Haslam is a dextrose monohydrate per Ingredion. As discussed above, The Neergaard Declaration declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6), which contradicts the latter assertion in Neergaard Declaration which asserted that the CERELOSE® Coarse Dextrose 020330 is “very compressible” or “directly compressible.” How can the structurally same “dextrose monohydrate” of Haslam and the claimed invention be both “non-directly compressible” and “directly compressible” as declared by Neergaard Declaration? Thus, the assertions in the Neergaard Declaration are contradictory.
Accordingly, as previously discussed and in the standing 103 rejection, it is maintained that that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Applicant argues:
“the Office Action refers to Robinson and appears to consent that Robinson is all about "compressible" dextrose and not "non- directly compressible" dextrose as instantly claimed. However, it appears that the Office Action for this element applies Haslam and the reference to CERELOSE® Coarse Dextrose 020330. However, as outlined above by Dr. Neergaard, CERELOSE® Coarse Dextrose 020330 is explicitly mentioned to be "very compressible" in the document applied by the Office Action, and Haslam does not even mention dextrose "monohydrate," but only the general term "dextrose" and "Cerelose" as an example of what this "dextrose" may be. Accordingly, Haslam does not remedy the deficiency of Robinson according to Dr. Neergaard. ¶17” (Remarks, page 11, middle paragraph).
In response, the Examiner disagrees. As discussed above, “compressible carbohydrate” as disclosed in Robinson does not mean the carboyhydrate such as dextrose is “directly compressible”. The terms “compressible” and “directly compressible” are not the same. There is no indication in Robinson, the carbohydrate such as dextrose is “directly compressible” and this is evident by claim 1, which also recites that the compressed chewable tablet contains a binder, thereby the ”compressible carbohydrate” such as dextrose is not “directly compressible.” Furthermore, as discussed in the standing 103 rejection, Haslam provided the guidance for using dextrose monohydrate as the dextrose in the chewable tablet of Robinson (see 103 rejection, pages 9-12 of this office action). Dextrose monohydrate as taught by Haslam meets the claimed “non-directly compressible particles of dextrose” as recited in claim 100, which is also evident by the Neergaard Declaration, which had declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6).
As discussed above, while instant claim 100 provided structure to the “non-directly compressible particles of dextrose” by reciting a Markush group of alternative species (i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate), claim 125 and 126, in contrast, do not provide any limiting structure to the claimed “non-directly compressible particles of dextrose” of claim 126 and “non-directly compressible particles of dextrate” of claim 125. Furthermore, as discussed above and in the 103 rejection, CERELOSE® Coarse Dextrose 020330 of Haslam is a dextrose monohydrate per Ingredion. As discussed above, The Neergaard Declaration declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6), which contradicts the latter assertion in Neergaard Declaration which asserted that the CERELOSE® Coarse Dextrose 020330 is “very compressible” or “directly compressible.” How can the structurally same “dextrose monohydrate” of Haslam and the claimed invention be both “non-directly compressible” and “directly compressible” as declared by Neergaard Declaration? Thus, the assertions in the Neergaard Declaration are contradictory.
Accordingly, as previously discussed and in the standing 103 rejection, it is maintained that that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Applicant argues:
“although Brys is no longer cited by the Office Action, it remains that the general teaching of this document is part of the state of the art. As previously mentioned during the prosecution of the instant application, it is mentioned in Brys that anhydrous dextrose, dextrose monohydrate as well as hydrated dextrose do not show sufficient compressibility (see sections [0010]-[0011] of Brys), i.e. Brys indicates that these components are non-directly compressible. Also, Brys is all about making compressible granules with a content of dextrose, and thus it cannot be alleged as done by the Office Action that the instantly claimed non-directly compressible particles of dextrose are not structure limiting. This is simply contrary to the general teaching of Brys and the general teaching of the prior art according to Dr. Neergaard. Neergaard Declaration, ¶19” (Remarks, page 12, 1st paragraph).
In response, the Examiner disagrees. As discussed above, while instant claim 100 provided structure to the “non-directly compressible particles of dextrose” by reciting a Markush group of alternative species (i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate), claim 125 and 126, in contrast, do not provide any limiting structure to the claimed “non-directly compressible particles of dextrose” of claim 126 and “non-directly compressible particles of dextrate” of claim 125. Furthermore, as discussed above and in the 103 rejection, CERELOSE® Coarse Dextrose 020330 of Haslam is a dextrose monohydrate per Ingredion. As discussed above, The Neergaard Declaration declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6), which contradicts the latter assertion in Neergaard Declaration which asserted that the CERELOSE® Coarse Dextrose 020330 is “very compressible” or “directly compressible.” How can the structurally same “dextrose monohydrate” of Haslam and the claimed invention be both “non-directly compressible” and “directly compressible” as declared by Neergaard Declaration? Thus, the assertions in the Neergaard Declaration are contradictory.
Accordingly, as previously discussed and in the standing 103 rejection, it is maintained that that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Applicant argues:
“Robinson is all about "compressible" carbohydrates, including compressible dextrose, contained in tablets. This is expressly part of claim 1 in Robinson as a critical element. Hence, for this reason alone, it cannot be alleged that "compressible" is just a characteristic that does not have any structural limitation on a tablet as alleged by the Office Action according to Dr. Neergaard. Additionally, it is explicitly mentioned in col. 6, lines 39-55 of Robinson that friability is to be kept relatively low to obtain a tablet with desired structure. A person skilled in the art would not attend to apply "non-directly compressible dextrose" with a hope of achieving low friability based on Robinson and as such one would not attend to combine Robinson with Haslam for this reason alone according to Dr. Neergaard. Neergaard Declaration, ¶20” (Remarks, page 12, 2nd paragraph).
In response, the Examiner disagrees. There is nothing in independent claims 100, 125 and 126 drawn to friability. Thus, Applicant’s argument and the Neergaard Declaration focusing on friability is not pertinent to the claimed invention.
As discussed above, “compressible carbohydrate” as disclosed in Robinson does not mean the carboyhydrate such as dextrose is “directly compressible”. The terms “compressible” and “directly compressible” are not the same. There is no indication in Robinson, the carbohydrate such as dextrose is “directly compressible” and this is evident by claim 1, which also recites that the compressed chewable tablet contains a binder, thereby the ”compressible carbohydrate” such as dextrose is not “directly compressible.” Furthermore, as discussed in the standing 103 rejection, Haslam provided the guidance for using dextrose monohydrate as the dextrose in the chewable tablet of Robinson (see 103 rejection, pages 9-12 of this office action). Dextrose monohydrate as taught by Haslam meets the claimed “non-directly compressible particles of dextrose” as recited in claim 100, which is also evident by the Neergaard Declaration, which had declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6).
As discussed above, while instant claim 100 provided structure to the “non-directly compressible particles of dextrose” by reciting a Markush group of alternative species (i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate), claim 125 and 126, in contrast, do not provide any limiting structure to the claimed “non-directly compressible particles of dextrose” of claim 126 and “non-directly compressible particles of dextrate” of claim 125. Furthermore, as discussed above and in the 103 rejection, CERELOSE® Coarse Dextrose 020330 of Haslam is a dextrose monohydrate per Ingredion. As discussed above, The Neergaard Declaration declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6), which contradicts the latter assertion in Neergaard Declaration which asserted that the CERELOSE® Coarse Dextrose 020330 is “very compressible” or “directly compressible.” How can the structurally same “dextrose monohydrate” of Haslam and the claimed invention be both “non-directly compressible” and “directly compressible” as declared by Neergaard Declaration? Thus, the assertions in the Neergaard Declaration are contradictory.
Accordingly, as previously discussed and in the standing 103 rejection, it is maintained that that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Applicant argues:
“when turning to Haslam, it appears that the Office Action relies on [0046-0048], where "Cerelose" is mentioned as an example of dextrose. The Office Action alleges that dextrose in Haslam is "non-directly compressible" based on the document of CERELOSE® Coarse Dextrose 020330. As a person skilled in the art, Dr. Neergaard finds this combination very problematic, since there is no evidence that "Cerelose" as mentioned in Haslam refers to CERELOSE® Coarse Dextrose 020330. Anyway, if so, it is expressly mentioned in the document to CERELOSE® Coarse Dextrose 020330 that it is "very compressible" and the combination does not remedy the deficiencies of Robinson (which document as a mandatory element recites "compressible dextrose"). Neergaard Declaration, ¶21” (Remarks, page 12, last paragraph to page 13).
In response, the Examiner disagrees. As discussed above, “compressible carbohydrate” as disclosed in Robinson does not mean the carboyhydrate such as dextrose is “directly compressible”. The terms “compressible” and “directly compressible” are not the same. There is no indication in Robinson, the carbohydrate such as dextrose is “directly compressible” and this is evident by claim 1, which also recites that the compressed chewable tablet contains a binder, thereby the ”compressible carbohydrate” such as dextrose is not “directly compressible.” Furthermore, as discussed in the standing 103 rejection, Haslam provided the guidance for using dextrose monohydrate as the dextrose in the chewable tablet of Robinson (see 103 rejection, pages 9-12 of this office action). Dextrose monohydrate as taught by Haslam meets the claimed “non-directly compressible particles of dextrose” as recited in claim 100, which is also evident by the Neergaard Declaration, which had declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6).
As discussed above, while instant claim 100 provided structure to the “non-directly compressible particles of dextrose” by reciting a Markush group of alternative species (i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate), claim 125 and 126, in contrast, do not provide any limiting structure to the claimed “non-directly compressible particles of dextrose” of claim 126 and “non-directly compressible particles of dextrate” of claim 125. Furthermore, as discussed above and in the 103 rejection, CERELOSE® Coarse Dextrose 020330 of Haslam is a dextrose monohydrate per Ingredion. As discussed above, The Neergaard Declaration declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6), which contradicts the latter assertion in Neergaard Declaration which asserted that the CERELOSE® Coarse Dextrose 020330 is “very compressible” or “directly compressible.” How can the structurally same “dextrose monohydrate” of Haslam and the claimed invention be both “non-directly compressible” and “directly compressible” as declared by Neergaard Declaration? Thus, the assertions in the Neergaard Declaration are contradictory.
Accordingly, as previously discussed and in the standing 103 rejection, it is maintained that that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Accordingly, the combined teachings of Robinson, Haslam, and Wittorff (and as evidenced by Ingredion) remained to render obvious Applicant’s claimed invention.
Applicant argues:
“Haslam only mentions the general term “dextrose” and the tradename “Cerelose” and does not mention “dextrose monohydrate” as alleged by the Office Action. A person skilled in the art would know that various grades fall under the category of “Cerelose,” and one cannot deduct from Haslam that a non-directly compressible grade of “Cerelose” is applied based on the teaching in Haslam according to Dr. Neergaard. And even if so, this would not be applied in combination with Robinson, since Robinson expressly mentions “compressible dextrose” as a mandatory component according to Dr. Neergaard. Neergaard Declaration, ¶22” (Remarks, page 13, 1st paragraph).
In response, the Examiner disagrees. As discussed above, “compressible carbohydrate” as disclosed in Robinson does not mean the carboyhydrate such as dextrose is “directly compressible”. The terms “compressible” and “directly compressible” are not the same. There is no indication in Robinson, the carbohydrate such as dextrose is “directly compressible” and this is evident by claim 1, which also recites that the compressed chewable tablet contains a binder, thereby the ”compressible carbohydrate” such as dextrose is not “directly compressible.” Furthermore, as discussed in the standing 103 rejection, Haslam provided the guidance for using dextrose monohydrate as the dextrose in the chewable tablet of Robinson (see 103 rejection, pages 9-12 of this office action). Dextrose monohydrate as taught by Haslam meets the claimed “non-directly compressible particles of dextrose” as recited in claim 100, which is also evident by the Neergaard Declaration, which had declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6).
As discussed above, while instant claim 100 provided structure to the “non-directly compressible particles of dextrose” by reciting a Markush group of alternative species (i.e., anhydrous dextrose, hydrated dextrose, and dextrose monohydrate), claim 125 and 126, in contrast, do not provide any limiting structure to the claimed “non-directly compressible particles of dextrose” of claim 126 and “non-directly compressible particles of dextrate” of claim 125. Furthermore, as discussed above and in the 103 rejection, CERELOSE® Coarse Dextrose 020330 of Haslam is a dextrose monohydrate per Ingredion. As discussed above, The Neergaard Declaration declared under oath that, “dextrose monohydrate” is a non-directly compressible particles of dextrose (Neergaard Declaration, paragraphs 5 and 6), which contradicts the latter assertion in Neergaard Declaration which asserted that the CERELOSE® Coarse Dextrose 020330 is “very compressible” or “directly compressible.” How can the structurally same “dextrose monohydrate” of Haslam and the claimed invention be both “non-directly compressible” and “directly compressible” as declared by Neergaard Declaration? Thus, the assertions in the Neergaard Declaration are contradictory.
Accordingly, as previously discussed and in the standing 103 rejection, it is maintained that that “non-directly compressible” is a characteristic feature, thereby is not structure limiting nor does it add or provide any structure to the “particles of dextrose ” or “particles of dextrate,” respectively of claims 100, 125, and 126. As discussed above, Robinson teaches the chewable tablet contains dextrose particles (dextrose powder), thereby meets the “non-directly compressible particles of dextrose” of claim 126, as the dextrose particles of Robinson is structurally the same as the particles of dextrose of claim 126 . Furthermore, as discussed above, Haslam provided the guidance using dextrose monohydrate (Cerelose® -- as evidenced by Ingredion™) or dextrate as the dextrose in the formation of the chewable tablet of Robinson (Haslam: [0046]-[0048]; claims 19-21). Accordingly, the dextrose particles (dextrose monohydrate or dextrate) used in Haslam is the structurally the same as the dextrose or dextrate particles of claims 100 and 125, thereby the dextrose or dextrate particles of Haslam meets the claimed “non-directly compressible particles of dextrose” or “non-directly compressible particles of dextrate” of claims 100 and 125. It is noted that "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Accordingly, the combined teachings of Robinson, Haslam, and Wittorff (and as evidenced by Ingredion) remained to render obvious Applicant’s claimed invention.
As a result, for at least the reasons discussed above and the preponderance of evidence, claims 100, 102-110, 112, 114-120, and 125-127 remain rejected as being obvious and unpatentable over the combined teachings of the cited prior arts in the pending 103 rejections as set forth in this office action.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/DOAN T PHAN/ Primary Examiner, Art Unit 1613
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