DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 11/21/2025 is acknowledged. Applicant traverses on the grounds that “Tan does not disclose the combination of elements set forth in the claims. Instead, it proposes substituted carboxymethylcellulose as an alternative to specific gums rather than adding it as another required element of the composition” (Applicant Arguments, Page 4). The argument is not found persuasive. The instant claims do not require the inclusion of carboxymethylcellulose and embrace the compositions of Tan et al comprising MCC and a biogum such a xanthan gum, welan gum, and so on.
The requirement is still deemed proper and is therefore made FINAL.
Applicant’s election without specifying traverse of a single composition in the reply filed on 11/21/2025 is also acknowledged.
The elected species read upon claims 20-31.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 20-23, 26 and 30 are rejected under 35 U.S.C. 103(a) as being unpatentable over Tan et al (WO 2013/085809; of record).
Claim 20 is drawn to an emulsifier composition comprising:
a) from 20 to 90 wt.% (more specifically, from 30 to 75 wt.% (claim 21)) of microcrystalline cellulose;
b) from 10 to 80 wt.% (more specifically, from 20 to 75 wt.% (claim 22), even more specifically, from 25 to 45 wt.% (claim 23)) of at least one biogum of microbial origin (more specifically, wherein the at least one biogum of microbial origin comprises a sphingan exopolysaccharide (claims 26 and 30)); and
c) from 0 to 20 wt.% of at least one cellulose ether or derivative thereof;
wherein all weight percentages are based on the total weight of the emulsifier composition.
Tan et al teach a “composition comprising: a) microcrystalline cellulose in an amount of from 20%-90% by weight of the composition [“more specifically, 40-75% by weight” (Paragraph 0020)]; b) a hydrocolloid in an amount of from 5%-50% by weight of the composition [“more particularly, 10-30% by weight” (Paragraph 0040)], wherein the hydrocolloid is selected from at least one member of the group consisting of… welan gum, or gellan gum [listed among 8 options]; and c) a starch in an amount of from 5%-50% by weight of the composition” (Abstract), further teaching that “[p]articular embodiments include… MCC, welan gum and/or gellan gum and starch” (Paragraph 0010).
As such, Tan et al teach particular embodiments of compositions comprising microcrystalline cellulose and at least one biogum of microbial origin comprising a sphingan exopolysaccharide (see Specification, Page 10, Lines 16-18: “[t]he at least one biogum of microbial origin… from the group of sphingan exopolysaccharides consist[s] of gellan, welan, diutan gum and mixtures thereof”) in amounts that overlap with the instantly claimed amounts.
As discussed by MPEP 2144.05, “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (citing In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)).
Accordingly, claims 20-23, 26 and 30 are rejected as prima facie obvious.
Claim 29 is rejected under 35 U.S.C. 103(a) as being unpatentable over Tan et al (WO 2013/085809; of record) as applied to claims 20-23, 26 and 30 above, as evidenced by Qu et al (IFEESD, 2016).
Claim 29 is drawn to the composition of claim 20, wherein the at least one biogum of microbial origin comprises a biogum produced by aerobic microbial fermentation.
As evidenced by Qu et al, “[w]elan gum is a… microbial polysaccharide produced from aerobic submerged fermention” (Page 679).
As such, claim 29 is also rejected as prima facie obvious.
Claims 20-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over Reo et al (US 2004/0191326) as evidenced by Munshi (US 4,427,681).
Claim 20 is drawn to an emulsifier composition comprising:
a) from 20 to 90 wt.% (more specifically, from 30 to 75 wt.% (claim 21)) of microcrystalline cellulose;
b) from 10 to 80 wt.% (more specifically, from 20 to 75 wt.% (claim 22), even more specifically, from 25 to 45 wt.% (claim 23)) of at least one biogum of microbial origin (more specifically, xanthan gum (claim 26)); and
c) from 0 to 20 wt.% (more specifically, from 5 to 15 wt.% (claim 24)) of at least one cellulose ether or derivative thereof (more specifically, sodium carboxymethylcellulose (claims 27-28));
wherein all weight percentages are based on the total weight of the emulsifier composition.
Reo et al disclose “an experiment in which varying amounts of Avicel RC-591 and xanthan gum were added to 53.7%... 60.9%... and 70.2% solids vehicles” (Paragraph 0127), comprising, in one example, “first making batches of the vehicle containing no viscosity enhancing substances” to which “[d]ifferent levels of xanthan gum and Avicel RC-591 were then added, and the resulting mixture shaken” (Paragraph 0129, referring to the formulation of Vehicle Numbers 1-7 in Table 7) and, in a second example, “by first adding water to a container followed by viscosity substances” and, subsequently, “the rest of the vehicle excipients were added (Paragraph 0129, referring to the formulation of Vehicle Numbers 9-15 in Table 7).
In either case, it would have been prima facie obvious to combine the Avicel RC-591 and xanthan gum prior to their addition to the vehicle (in formulating Vehicle Numbers 1-7) or prior to their addition to water (in formulating Vehicle Numbers 9-15) (see MPEP 2144.04(IV)).
The combined composition comprising Avicel RC-591 and xanthan gum reads on the instantly claimed composition for the following reasons:
Specifically, Reo et al teach that xantham gum and Avicel RC-591 were added in ratios of xanthan gum:Avicel RC-591 of about 1:1.19 (see, e.g., Page 13, Table 7, Vehicle Number 5 (comprising 0.57 % w/w xanthan gum and 0.68% w/w Avicel RC591) and about 1:1.4 (see, e.g., Page 13, Table 7, Vehicle Number 12 (comprising 0.005 % w/w xanthan gum and 0.007% w/w Avicel RC591)).
As evidenced by Munshi, “Avicel RC-591 microcrystalline cellulose… is a mixture of about 89 parts microcrystalline cellulose and 11 parts sodium carboxymethylcellulose” (Column 1, Lines 42-45).
Accordingly, it is calculated that the amount of microcrystalline cellulose, xanthan gum, and sodium carboxymethylcellulose in the Avicel RC-591 and xanthan gum combination added to Vehicle Number 5 as taught by Reo et al would comprise:
a) about 48.4 wt.% microcrystalline cellulose;
b) about 45.7 wt.% xanthan gum; and
c) about 6.0 wt.% sodium carboxymethylcellulose.
And the combined amount of microcrystalline cellulose, xanthan gum, and sodium carboxymethylcellulose in the Avicel RC-591 and xanthan gum combination added to Vehicle Number 12 as taught by Reo et al would comprise:
a) about 51.9 wt.% microcrystalline cellulose;
b) about 41.7 wt.% xanthan gum; and
c) about 6.4 wt.% sodium carboxymethylcellulose.
In view of all of the foregoing, claims 20-24 and 26-28 are rejected as prima facie obvious.
Claim 25 is drawn to composition of claim 20, wherein a weight ratio of (a):(b):(c) is from 2 to 8 (a), from 1 to 20 (b), and (c) is 1.
The weight ratio of (a):(b):(c) in the Avicel RC-591 and xanthan gum combination added to Vehicle Number 5 as taught by Reo et al would entail 8.07 (a), 7.62 (b), and 1 (c).
And the weight ratio of (a):(b):(c) in the Avicel RC-591 and xanthan gum combination added to Vehicle Number 12 as taught by Reo et al would entail 8.11 (a), 6.52 (b), and 1 (c).
As discussed by MPEP 2144.05, “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists” (citing In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465 (Fed. Cir. 1997)). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close (citing Titanium Metals Corp. of America v. Banner, 778 F.2d 775 (Fed. Cir. 1985)).
As such, claim 25 is also rejected as prima facie obvious.
Claim 29 is rejected under 35 U.S.C. 103(a) as being unpatentable over Reo et al (US 2004/0191326) as evidenced by Munshi (US 4,427,681) as applied to claims 20-28 above, as further evidenced by Babbar et al (Curr Microbiol 52:287-292, 2006).
Claim 29 is drawn to the composition of claim 20, wherein the at least one biogum of microbial origin comprises a biogum produced by aerobic microbial fermentation.
As evidenced by Babbar et al, “[x]anthan gum… [is] prepared commercially by aerobic submerged fermentation from Xanthomonas capmpestris” (Abstract).
As such, claim 29 is also rejected as prima facie obvious.
Claims 30-31 are rejected under 35 U.S.C. 103(a) as being unpatentable over Reo et al (US 2004/0191326) as evidenced by Munshi (US 4,427,681) as applied to claims 20-28 above, in further view of Sabio et al (US 2013/0102705).
Claims 30-31 are drawn to the composition of claim 20, wherein the at least one biogum of microbial origin comprises a sphingan exopolysaccharide (claim 30), more specifically wherein the at least one biogum of microbial origin is diutan gum (claim 31).
As discussed above, Reo et al teach compositions comprising microcrystalline cellulose, xanthan gum, and sodium carboxymethylcellulose.
As such, the compositions of Reo et al differ from the composition of claims 30-31 in comprising xanthan gum as the biogum of microbial origin as opposed to diutan gum.
Yet, Sabio et al teach as “[e]xamples of viscosity-modifying agents… natural or modified gums, in particular diutan… xanthan” and so on (Paragraph 0066).
Accordingly, in further view of Sabio et al, it would have been prima facie obvious to modify the composition of Reo et al by utilizing diutan gum in place of xanthan gum. The simple substitution of one known viscosity modifying agent for another known viscosity modifying agent is prima facie obvious.
As such, claims 30-31 are also rejected as prima facie obvious.
Conclusion
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611