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 . 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.
Priority
The instant application is a 371 of PCT/JP2019/043583 filed on 11/07/2019.
Status of the Claims
The claim amendments and remarks filed on 11/28/2025 is acknowledged. Claims 1 and 10 are amended. Claims 13-15 are newly added.
Accordingly, claims 1-15 are pending and being examined on the merits herein.
Withdrawn Rejections
The 35 USC 101 rejection over claim 12 is withdrawn because claim 1 now recites “wherein the cellulose is in the form of a crystalline cellulose”, which is a non-naturally occurring compound. Furthermore, the composition comprising the crystalline cellulose and the naturally occurring cello-oligosaccharides in the recited ratios was determined to have a markedly different characteristic over the closest natural counterpart (cello-oligosaccharides found in plant matter) because Applicant has demonstrated that the recited ratio of 4.0-7.5 mg cello-oligosaccharides per 5 gram of cellulose composition provides lower tablet hardness reduction and low reactivity with active components as shown in Tables 4 and 5 (pages 57-58) of the instant specification.
The 35 USC 103 rejection over Capanema for claim 12 is withdrawn for reasons indicated in the allowable subject matter section below.
The following grounds of rejection are new and amended as necessitated by Applicant’s amendments.
Claim Rejections - 35 USC § 112(b)
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 14 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 14 recites “wherein the crystalline cellulose is selected from (i) a microcrystalline cellulose specified by the Joint FAO/WHO Expert Committee on Food Additives … (iv) a crystalline cellulose disclosed in the United States Pharmacopoeia and the European Pharmacopeia”.
Claim 14 is indefinite because it is not clear which edition / volume of the Joint FAO/WHO Expert Committee on Food Additives in (i) and the United States Pharmacopoeia and the European Pharmacopeia in (iv) is being referenced to, and thus it is unclear which crystalline celluloses are being selected from.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 11, and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
Claim 1 recites “A cellulose composition comprising cellulose and a water-soluble substance including cellooligosaccharides from trisaccharides to heptasaccharides, wherein the cellooligosaccharide content per 5 g of the cellulose composition is at least 1.5 mg but not more than 9.0 mg and wherein the cellulose is in the form of a crystalline cellulose”, and claim 15 recites “A cellulose composition comprising cellulose and a water-soluble substance including cellooligosaccharides from trisaccharides to heptasaccharides, wherein the cellooligosaccharide content per 5 g of the cellulose composition is at least 1.5 mg but not more than 9.0 mg and wherein an average degree of polymerization of the cellulose is 100 to 400”.
Subject matter that is not patent eligible is determined by evaluating a claim for patentability based on the eligibility test set forth below:
(Step 1) Is the claim directed to one of the four statutory categories, i.e., a process, machine, manufacture, or composition of matter?
For the instant claims, the answer is “Yes” because the claims are to a composition of matter.
(Step 2a) Prong 1: Does the claim recite or involve a judicial exception?
The answer is “Yes” because the composition includes cello-oligosaccharides, which are derived from natural sources such as plant material, specifically pine needles and/or cornstalk as evidenced by TCI Chemicals (in PTO-892 dated 07/29/2025). Furthermore, claim 15 recites cellulose, which is also derived from natural sources as evidenced by Xiao et al. (in PTO-892 dated 07/29/2025).
Furthermore, MPEP 2106.04(b) section II states that “When a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A.”, and MPEP 2160.4(c) states that “The markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions”, and further sets forth the markedly different characteristic analysis consisting of A. selecting the appropriate counterpart, B. identifying appropriate characteristics for analysis, and C. evaluating characteristics to determine whether they are “markedly different”.”
Claim 1 is drawn to a cellulose composition comprising crystalline cellulose and cello-oligosaccharides in the recited ratios. The closest counterpart in nature for the claimed cellulose composition is cello-oligosaccharides that are present in plant matter such pine needles and/or cornstalk as evidenced TCI Chemicals (in PTO-892 dated 07/29/2025).
Applicant demonstrates in Tables 4 and 5 that their claimed cellulose composition, having a ratio of 4.0-7.5 mg per cello-oligosaccharide per 5 g cellulose composition, exhibited low reactivity with active components and favorable tablet hardness reduction. Therefore, the appropriate characteristic for the claimed cellulose composition is preventing tablet hardness reduction and having low reactivity with active components.
Here, while Applicant has demonstrated a markedly different characteristic for compositions comprising the crystalline cellulose and the naturally occurring cello-oligosaccharides in a ratio of 4.0-7.5 mg per cello-oligosaccharide per 5 g cellulose composition, claim 1 currently recites a ratio of 1.5 mg-9.0mg per 5 g cellulose composition, which is not commensurate in scope with the ratios presented in Tables 4 and 5. Therefore, claim 1 does not provide a markedly different characteristic over the closest natural counterpart for the full scope of claim 1 because Applicant has not provided evidence of a markedly different characteristic for the entire ratio range recited in instant claim 1.
Furthermore, claims 2-5, 11, and 13-14 recite proportion of cello-oligosaccharides to the total water-soluble substance, that the cellulose composition is a powder with specific properties of the particles, and specific crystalline cellulose forms. However, these additional limitations also do not provide a markedly different characteristic over the closest natural counterpart because Applicant has not demonstrated that simply changing the form of the composition to a powder with specific properties as well as having specific crystalline cellulose forms will also have the tablet hardness reduction and low reactivity with active components for the entire scope (recited ratio range) of claim 1.
In regards to claim 15, claim 15, under broadest reasonable interpretation, recites natural cellulose and cello-oligosaccharides with the cellulose having a DP of 100-400. Here, the recited DP is interpreted as a simple breakdown of the natural cellulose and not necessarily an isolation of a non-natural compound such as crystalline cellulose. Therefore, the cellulose composition in claim 15 does not amount to a markedly different characteristic because the simple mixture of broken-down natural cellulose and cello-oligosaccharides, in the absence of additional components recited in the claims, does not change the structure or function of the cellulose and cello-oligosaccharides in its natural state (in plant matter).
(Step 2a) Prong 2: Does the claim recite additional elements that integrate the judicial exception into a practical application?
The answer is “No”.
In regards to claim 1, the recitation of a non-natural crystalline cellulose and certain ratio amounts of the natural cello-oligosaccharides do not integrate the judicial exception (cello-oligosaccharides) into a practical application because while Applicant has demonstrated that certain ratios of cello-oligosaccharides in the cellulose composition will have lower tablet hardness reduction and low reactivity with active components as described above, the claim itself does not recite an integration of such properties into a practical application, and furthermore as described above, Applicant also has not demonstrated that these properties apply for the full scope (entire ratio amount) recited in claim 1.
Furthermore, the limitations in claims 2-5, 11, and 13-14 do not integrate into a practical application because Applicant has not provided evidence that simply changing the form of the composition to a powder with specific properties as well as the selection of certain crystalline cellulose forms will recite an integration of the judicial exception into a practical application.
In regards to claim 15, claim 15 does not integrate the judicial exception into a practical application because the simple mixture of broken-down natural cellulose and cello-oligosaccharides, in the absence of additional components recited in the claims, does not recite an integration of the judicial exception into a practical application.
(Step 2b) Does the claim as a whole recite additional elements that amount to something significantly more than the judicial exception(s)?
The answer is “No.”
In regards to claim 1, the recitation of a non-natural crystalline cellulose and certain ratio amounts of the natural cello-oligosaccharides do not recite additional elements that would amount to something significantly more than the judicial exception (cello-oligosaccharides) because while Applicant has demonstrated that certain ratios of cello-oligosaccharides in the cellulose composition will have lower tablet hardness reduction and low reactivity with active components as described above, the claim itself does not recite such properties and/or additional elements that amount to significantly more than the judicial exception, and furthermore as described above, Applicant also has not demonstrated that these properties apply for the full scope (entire ratio amount) recited in claim 1.
Furthermore, the limitations in claims 2-5, 11, and 13-14 also do not recite additional elements that amount to something significantly more than the judicial exception because Applicant has not provided evidence that simply changing the form of the composition to a powder with specific properties as well as the selection of certain crystalline cellulose forms amounts to significantly more than the judicial exception.
In regards to claim 15, the cellulose composition in claim 15 does not recite additional elements that amount to something significantly more than the judicial exception because the simple mixture of broken-down natural cellulose and cello-oligosaccharides, in the absence of additional components recited in the claims, does not amount to significantly more than the judicial exception.
Response to Arguments
Applicant’s arguments filed on 11/28/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that claim 1 now recites “crystalline cellulose”. Applicant states that natural cellulose cannot take the form of a crystalline cellulose without partial depolymerization and refers to several references for evidence. Applicant further states that claim 13 recites a powder wherein “each single particle of the powder contains cellulose and the cello-oligosaccharides”. Applicant states that the BRI of claim 13 cannot include a loose mixture of two powders and therefore claim 13 inherently possess the capability of having the properties of tablet hardness reduction rate and low reactivity with active components.
Here, Applicant has only demonstrated a markedly different characteristic over a ratio of 4.0-7.5 mg cello-oligosaccharides per 5 gram of cellulose composition, which provides lower tablet hardness reduction and low reactivity with active components as shown in Tables 4 and 5 (pages 57-58) of the instant specification. Claim 1 currently recites a ratio of 1.5 mg-9.0mg per 5 g cellulose composition, which is not commensurate in scope with the ratios presented in Tables 4 and 5. Therefore, since Applicant has not provided evidence for the full scope of instant claim 1, a markedly different characteristic is not present for the entire scope of claim 1.
Furthermore, claim 13 also does not provide a markedly different characteristic because Applicant has not demonstrated that simply changing the form of the composition to a powder with specific properties will also have the tablet hardness reduction and low reactivity with active components for the entire scope (recited ratio range) of claim 1.
It is noted that claim 12 is commensurate in scope with the data presented in Tables 4 and 5 and is 101 eligible.
Applicant states that claim 15 recites an average DP of 100 to 400, and that natural cellulose has a DP of 440 or more according to the Japanese Pharmacopoeia. Therefore, Applicant states that claim 15 cannot be a product of nature.
Applicant’s argument described above was not found persuasive the recited DP in claim 15 is interpreted as a simple breakdown of the natural cellulose and not necessarily an isolation of a non-natural compound such as crystalline cellulose. Therefore, the cellulose composition in claim 15 does not amount to a markedly different characteristic because the simple mixture of broken-down natural cellulose and cello-oligosaccharides, in the absence of additional components recited in the claims, does not change the structure or function of the cellulose and cello-oligosaccharides in its natural state (in plant matter).
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.
Claims 1-4, 6, 10-13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (US20170275385 in PTO-892 dated 03/06/2025).
Capanema et al. discloses cellulose-containing compositions comprising a type-I cellulose, a type-II cellulose, amorphous cellulose, or a combination thereof (see Abstract). Capanema et al. discloses that the cellulose in their composition can be present in a range of 5-100% by weight of the composition (see paragraph 0086). Capanema discloses that their cellulose composition is substantially present in a form of microcrystalline cellulose (paragraph 0104). Capanema discloses that the cellulose product can comprise cellulose having a degree of polymerization of 10-250 (paragraph 0094). Capanema et al. discloses their cellulose product can be in a form of a powder with a particle size less than about 160 um (see paragraph [0136]). Furthermore, Capanema et al. discloses their compositions can comprise of a water-soluble fraction comprising of at least one cello-oligosaccharide including cellohexaose, cellopentaose, cellotetraose, and cellotriose in a range of 0-20% by weight such as less than about 16% by weight of the composition on a dry basis (see paragraph [0122] and paragraph [0125]). Capenema et al. teaches in one embodiment that a water-soluble substance can be present in an amount of 0 to 0.3% wt% based on total weight of the cellulose product on a dry basis (see paragraph [0123]), which overlaps with the recited “at least 1.5 mg but not more than 9.0 mg” per 5 g composition (equates to ~0.03% to ~0.18% by weight) in claim 1 and the recited “at least 2.5 mg but not more than 12.5 mg” per 5 g composition (equates to ~0.05% to ~0.25% by weight) in claim 2. Here, the water-soluble substance is being interpreted as also including the water-soluble fraction. Even though Capanema et al. does not explicitly disclose what components make up the water-soluble substance, a skilled artisan would understand that because the water-soluble fraction contains all water-soluble substances (ex. cello-oligosaccharides) and the fact that Capanema et al. does not disclose any other types of water-soluble substances except for the disclosed water-soluble fraction, the disclosed water-soluble substance must include the disclosed water-soluble fraction.
Capanema et al. discloses in Example 2 a composition of their water-soluble fraction (see Table 2). Capanema et al. discloses that glucose and glucose oligomers up to cellohexaose are summarized in the last row of Tables 2-3, and they represent about 85% of the total sample based on a peak integration basis (see paragraph 0333). Here, the percentage of cello-oligosaccharides as defined in the claims (“from trisaccharides to heptasaccharides”) in proportion to total water soluble fraction is ~57.78%, which reads within the recited range in claim 3. Capanema et al. discloses their composition can further comprise at least one pharmaceutically-active ingredient (see paragraph [0131]), and that the cellulose product can be employed in a pharmaceutical formulation and formed into a tablet exhibiting suitable hardness and/or friability (see paragraph 0082).
The difference between Capanema and the claimed invention is that Capanema does not exemplify a composition comprising a water-soluble substance in the claimed ratio of at least 1.5 mg – 9.0 mg per 5 g cellulose composition (or 0.03% by weight to 0.18% by weight) recited in claim 1.
It would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the claimed cellulose composition of Capanema by including the water-soluble fraction comprising the cello-oligosaccharides as disclosed in Table 2 and further optimizing the percent weight of the water-soluble fraction to arrive at the claimed invention because Capanema et al. provides guidance that their cellulose products can include a water-soluble substance that can contain the water-soluble fraction comprising the claimed cello-oligosaccharides in amounts of 0 to 0.3% wt% based on total weight of the cellulose product.
In regards to claim 10, the difference between Capanema et al. and the claimed invention is that Capanema et al. does not expressly teach a composition wherein the active component content relative to a total mass of the tablet is at least 0.01% to 50% by mass.
Capanema et al. teaches that their cellulose product can be used as a direct compression excipient in a direct compression formulation in amounts range from 5-70% by weight of the formulation (see paragraph [0135]).
Therefore, one of ordinary skill in the art would have found it obvious before the effective filing date of the claimed invention to have prepared a direct compression formulation comprising of 5-70% by weight and include a pharmaceutically active ingredient ranging from 30-95% by weight to complete the formulation, which would overlap with the recited range in claim 10. One of ordinary skill in the art would have made this modification to combine because Capanema et al. provides guidance that their cellulose product can include a pharmaceutically active ingredient as described above, and furthermore, Capanema et al. discloses that in one embodiment, the excipient may represent an inactive substance formulated alongside an “active pharmaceutical ingredient” (API) of a pharmaceutical formulation (see paragraph [0075]).
In regards to instant claim 13, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the cellulose composition described above in the form a powder because Capanema discloses that their cellulose product can be in a form of a powder. Furthermore, this powder product as disclosed in Capanema would necessarily have each particle having the cellulose and the cello-oligosaccharides, since Capenema discloses that their cellulose product contains both cellulose and cello-oligosaccharides as described above.
In regards to instant claim 15, it would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the cellulose composition described above to have a DP of 10-250 as disclosed in Capanema. One of ordinary skill in the art could have arrive at the claimed invention because Capanema discloses their cellulose product having a DP of 10-250, which overlaps with the recited DP range. See MPEP 2144.05 I.
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (US20170275385 in PTO-892 dated 03/06/2025) as applied to claims 1 and 4 above, and further in view of Horio et al. (International Journal of Pharmaceutics, 2014 in PTO-892 dated 03/06/2025).
Capanema et al. teaches the composition of claim 4 as described above. Furthermore, Capanema et al. teaches that their cellulose product can be in a microcrystalline cellulose form (see paragraph [0104]).
The difference between Capanema et al. and the claimed invention is that Capanema et al does not teach an aspect ratio of the powder is at least 1.8 but not more than 4.0
Horio et al. teaches powder flowability of microcrystalline cellulose particles having different particle shapes, whose aspect ratios ranged from 1.8 to 6.4 (see Abstract). Specifically, Horio et al. discloses that in the pharmaceutical industry, microcrystalline cellulose particles with aspect ratios of approximately 2 are often used for direct compression excipients because of their superior flowability, and that these particles with higher aspect ratios are used, in a tight packing state, to increase tablet hardness (see pg 573, right column).
It would have been prima facie obvious to combine Capanema and Horio before the effective filing date of the claimed invention by preparing a powdered form of the claimed cellulose composition as disclosed in Capanema et al. with an aspect ratio of 1.8-4.0 as disclosed in Horio et al. to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to make this modification with a reasonable expectation of success because Capanema et al. discloses their cellulose product can be directly compressed for pharmaceutical applications, and Horio et al. provides further guidance that cellulose particles with aspect ratios of approximately 2 are often used for direct compression excipients such as disclosed in Capanema et al. because of their superior flowability.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (US20170275385 in PTO-892 dated 03/06/2025) as applied to claim 6 above, and further in view of Zarmpi et al. (European Journal of Pharmaceutics and Biopharmaceutics, 2017 in PTO-892 dated 03/06/2025).
Capanema et al. teaches the composition of claim 6 as described above. Furthermore, Capanema et al. teaches in some embodiments of their cellulose product, when a specific formulation is required, a lubrication aid such as magnesium stearate may need to be added (see paragraph [0133]).
The difference between Capanema et al. and the claimed invention is that Capanema et al. does not teach that the lubricant has a 0.3%-5% weight by mass related to a total mass of the tablet.
Zarmpi et al. teaches lubricants such as magnesium stearate are used in solid dosage forms manufacture to enhance processability of intermediate blends and tablets (see section 5.3 “Lubricants”). Furthermore, Zarmpi et al. teaches that a range of 0.25–5.0% w/w magnesium stearate is used in drug product development (see section 5.3.1.4 “Level”).
It would have been prima facie obvious to combine Capanema and Zarmpi before the effective filing date of the claimed invention by preparing a tablet form of the claimed cellulose composition with a lubricant such as magnesium stearate as disclosed in Capanema and at 0.3%-5% weight by mass related to a total mass of the tablet as disclosed in Zarmpi et al. to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to made this modification with a reasonable expectation of success because Capanema et al. discloses their cellulose product can include a lubricant aid such as magnesium stearate, and Zarmpi et al. provides further guidance that a range of 0.25–5.0% w/w magnesium stearate is commonly used in drug product development.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Capanema et al. (US20170275385 in PTO-892 dated 03/06/2025) as applied to claim 1 above, and further in view of The 17th edition of the Japanese Pharmacopoeia (JP) published 04/01/2016 (in PTO-892).
Capanema et al. teaches the composition of claim 1 as described above. Furthermore, Capanema discloses that their cellulose product can be used as an excipient (paragraph 0130), which represents an inactive substant formulated alongside an active pharmaceutical ingredient (API) in a pharmaceutical formulation (paragraph 0075).
Capanema, however, does not teach using a crystalline cellulose as defined by the recited references in instant claim 14.
The 17th JP is an official document that defines the specifications, criteria, and standard test methods necessarily to properly assure the quality of medicines in Japan (see first paragraph left column page 7 section “Preface”). The 17th JP discloses these methods and standards for several pharmaceutical ingredients including microcrystalline cellulose on pages 664-667.
It would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the microcrystalline cellulose of Capanema according to the standards disclosed in the 17th JP to arrive at the claimed invention. One of ordinary skill in the art could have combined prior art elements according to known methods to yield predictable results because Capanema discloses the use of cellulose products containing microcrystalline cellulose in pharmaceutical formulations, and the 17th JP provides standards of microcrystalline cellulose to properly assure the quality of medicines in Japan.
Response to Arguments
Applicant’s arguments filed on 11/28/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that the claimed embodiments would not have been obvious at least because they possess unexpected results. Applicant states that Example 1,2, 5, and Comparative Example 1 were manufactured using the same manufacturing method except for the amount of cello-oligosaccharide extract added. Applicant states that Example 1, 2, and 5 demonstrate better tablet hardness and reduction rates and that these Examples demonstrate the unexpected favorable effects by setting cello-oligosaccharide content within the claimed range.
Upon reconsideration, Applicant has demonstrated the criticality of the oligosaccharide content of 4.0 – 7.5 mg per 5 g cellulose composition to have less tablet hardness reduction and low reactivity with active components. However, claim 1 currently recites “at least 1.5 mg but not more than 9.0 mg”, which is not commensurate in scope with the range presented in Tables 4 and 5, which demonstrate criticality of a range of 4.0 -7.5 mg of oligosaccharide content. See MPEP 716.02 (d) “… the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.”.
It is noted that the ratio recited in claim 12 is commensurate in scope with the data presented in Tables 4 and 5 and is allowable for the reasons indicted below.
Allowable Subject Matter
Claim 12 is objected as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art is Capanema.
As described above, Capanema discloses a cellulose product comprising the recited microcrystalline cellulose and the water-soluble substance comprising the cello-oligosaccharides. Furthermore, Capanema discloses overlapping amounts for the two components such as that an ordinary skilled artisan could have arrived at the claimed invention as described above.
Additionally, an ordinary skilled artisan could have optimized the amounts for suitable tablet hardness reduction because Capanema discloses using their cellulose compositions for tablets and suggests that their product can used for suitable tablet hardness (para 0081-0082). Furthermore, Takahashi (US20100247665A1 in PTO-892) discloses cellulose compositions comprising sugar alcohols and crystalline cellulose (Abstract), and by employing a certain blend ratio of these two components, the composition exhibits low degree of reactivity with active substances and exhibiting superior disintegration properties in water, has a high degree of hardness and is resistant to abrasion (paragraph 0058).
However, an ordinary skilled artisan would not have known or could not have considered before the effective filing date of the claimed invention to further optimize the amounts of the oligosaccharides in combination with the crystalline cellulose to obtain both properties because while Takahashi discloses cellulose compositions with suitable tablet hardness and low reactivity, Takahashi is only disclosing these properties for a combination of sugar alcohols and cellulose and not with cello-oligosaccharides. Furthermore, the prior art has not disclosed or suggested the specific combination of crystalline cellulose and cello-oligosaccharides to have both less tablet hardness reduction and low reactivity with active components, and Applicant has demonstrated that their claimed range of 4.0-7.5 mg of cello-oligosaccharide content per 5 gram of cellulose composition is critical to have these two properties.
Therefore, Applicant’s showing of the criticality for the claimed range in claim 12 is unexpected and non-obvious over the prior art.
Conclusion
Claims 1-11 and 13-15 are rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693