DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/02/2026 has been entered.
Status of the Claims
This action is in response to papers filed 01/22/2026, in which claim 6 was canceled; claim 1 was withdrawn; and claims 13 and 14 were amended. All the amendments have been thoroughly reviewed and entered.
Claims 2-5 and 7-14 are under examination.
Maintained-Modified Rejections
Modification Necessitated by Applicant’s Claim Amendments
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.
Claim(s) 2-5, 7-11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (US 2010/0130445 A1; hereafter as “Yang ‘445”) in view of Yang et al (WO 2017/205230 A1; hereafter as “Yang ‘230”).
Regarding claims 13 and 14, Yang ‘445 teaches a method of inhibiting biofilm formation in an oral cavity of a subject comprising applying to a surface of the oral cavity, composition containing less than 5% by weight of glucosamine such as 1% by weight of glucosamine (Abstract; [0004]-[0050] and [0072]-[0094]; claims 1-31).
However, Yang ‘445 does not teach the one or more surfactant of Formula I of claims 13 and 14.
Regarding the one or more surfactant of Formula I of claims 13 and 14, Yang ‘230 teaches a method of inhibit biofilm formation in an oral cavity of a subject comprising applying to a surface of the oral cavity, a composition containing a combination of a compound of Formula I and a compound of Formula II, wherein Formulation I has the following structure:
HOCH2-(-CHOH-)-CH2NR1R2
wherein R1 is a hydrogen atom or an alkyl group having 1 to 2 carbon atoms, R2 is C(0)R3, wherein R3 is a C7-C9 alkyl group, and n is an integer from about 2 to about 5; and Formula II has the following structure:
HOCH2-(-CHOH-)m-CH2NHR4
wherein R4 is a hydrogen atom or an alkyl group, m is an integer from about 2 to about 5 (Abstract; pages 1-10, 13-14, 25-29, 32, and 35; claims 1-21).
Yang ‘230 teaches Formulas I and II are amino sugar alcohols and derivatives having the common names D- glucamine, N-methyl-D-glucamine, N-ethyl-D-glucamine, N-octyl-D-glucamine, and N- methyl-N-octanoyl-D-glucamine, N-methyl-N-nonanoyl-D-glucamine, N-methyl-N- decanoyl-D-glucamine (pages 7-8, 28, 32, and 35). Yang ‘230 teaches the composition contains N-ethyl-D-glucamine and N-methyl-N-nonanoyl-D-glucamine ("MEGA-9") (pages 7-8, 28, 32, and 35). Yang ‘230 teaches Formula I and Formula II are each, independently present in the composition in an amount of about 1 wt% to about 3 wt% such as about 2 wt% Formula I or Formula II (pages 8-10 and 32).
It would have been obvious to one of ordinary skill in the art to include the composition containing a combination of a compound of Formula I and a compound of Formula II such as N-ethyl-D-glucamine and N-methyl-N-nonanoyl-D-glucamine ("MEGA-9") of Yang ‘230 in the composition of Yang ‘445, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Yang ‘445 and Yang ‘230 are commonly drawn to dental compositions and methods of inhibiting biofilm formation in an oral cavity using the dental composition, and thus, it would have been reasonably obvious to combine at least two active ingredients (glucosamine, N-ethyl-D-glucamine and N-methyl-N-nonanoyl-D-glucamine) known to be useful in inhibiting biofilm formation in an oral cavity, as such combination would provide at least an additive effect in inhibiting biofilm formation in the oral cavity. One of ordinary skill in the art would have reasonable expectation of success in doing so because it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). It is prima facie obvious to combine individual ingredients for their known function. In re Linder, 173 USPQ 356; In re Dial, 140 USPQ 244.
Regarding claims 2-4, as discussed above, Yang ‘230 provided the guidance for using compounds such as D-glucamine, N-ethyl-D-glucamine and N-methyl-N-nonanoyl-D-glucamine ("MEGA-9"), which meets the claimed compound of Formula I of claims 13 and 14.
Regarding claim 5, Yang ‘445 teaches the composition containing less than 5% by weight of glucosamine ([0037] and [0046]), which overlaps the claimed range of from 1.5 wt% to 2.5 wt%. 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 total weight of glucosamine in the composition would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claim 7, Yang ‘445 and Yang ‘230 teach the composition contains water (Yang ‘445: [0009], [0048] and [0063]; Yang ‘230: pages 14 and 32), wherein Yang ‘230 teaches the water content can be optimize to an amount of at least about 10 wt.-% (Yang ‘230: pages 14 and 32), which overlaps the claimed range of “from 5 wt% to 98 wt%”. As discussed above, it is noted 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 the amount of water in the composition would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claim 8, Yang ‘445 and Yang ‘230 teach the composition can be formulated into a gel (Yang ‘445: [0005], [0068]; claim 20; Yang ‘230: page 23), wherein Yang ‘230 teaches the water content can be optimize to an amount of at least about 10 wt.% (Yang ‘230: pages 14 and 32), which overlaps the claimed range of “from 10 wt% to 95 wt%”. As discussed above, it is noted 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 the amount of water in the composition would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claim 9, Yang ‘445 teaches the composition can formulated into an oral rinse (Yang ‘445: [0004]-[0005], and [0068]; claim 20), wherein Yang ‘230 teaches the water content in the composition can be optimize to an amount of at least about 10 wt.% (Yang ‘230: pages 14 and 32), which overlaps the claimed range of “from 5 wt% to 65 wt%”. As discussed above, it is noted 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 the amount of water in the composition would have been obvious before the effective filing date of applicant's invention. See MPEP §2144.05 (I)-(II).
Regarding claim 10, Yang ‘445 teaches the composition can formulated into an oral rinse and an emulsion (Yang ‘445: [0004]-[0005], and [0068]; claim 20), wherein Yang ‘230 teaches the emulsion have an aqueous phase and oil phase (Yang ‘230: pages 13, 16, 20 and 23).
Regarding claim 11, Yang ‘230 teaches and provide guidance for formulating the composition into a toothpaste that further contains dental abrasives (Yang ‘230: pages 10-12; claims 1-8).
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 in art the 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 01/22/2026 have been fully considered but they are not persuasive.
Applicant argues that the scope of the amended claims 13 and 14 is reasonable. Applicant alleges that none of the cited two references “teaches or suggests to combine glucosamine, a glucosamine salt, N-acetylglucosamine with a surfactant of Formula I, let alone any reason why a person of skilled art would expect a synergistic enhancement.” Applicant alleges that “it is meaningful that adding 2% glucosamine to 0.75% MEGA is a sizable increase in biofilm kill, given that 2% glucosamine alone was weakly effective against the total biofilm,” and “[t]hus, the results are surprising.” (Remarks pages 5-8).
In response, the Examiner disagrees. There are two issues with respect to Applicant’s alleged unexpected results shown in Example Ex.4. First is claims 13 and 14 are not commensurate in scope with the formulation from Example Ex. 4, and second is that Applicant has not compared Applicant’s alleged unexpected results to the closest prior art.
With respect to the first issue, while Applicant has amended the surfactant of Formula I in claims 13 and 14 so as said surfactant is reasonably commensurate in scope with the MEGA-9 in Example Ex. 4, claim 13 and 14 as amended remain not commensurate in scope with the formulation from Example Ex. 4 to which Applicant’s alleged exhibited unexpected results.
As previously discussed, the experimental results shown in Table 2 of the specification (pages 32-33) are drawn to using glucosamine HCl in combination with specifically MEGA-9 (N-methyl-N-nonanoyl-D-glucamine) as the surfactant of Formula I, wherein the alleged synergistic anti-biofilm properties was seen when MEGA-9 is used at a weight concentration of 0.75 wt% and glucosamine HCl is used at weight concentrations of 0.25 wt%, 0.75 wt%, or 2 wt% (Ex.2 -Ex.4 from Table 2, respectively). However, claims 13 and 14 as amended remain broadly drawn to a composition comprising from 1 wt% to 3 wt% glucosamine, a glucosamine salt, N-acetylglucosamine, or a combination thereof, and from 0.75 wt% to 3 wt% one or more surfactant having Formula I.
As previously discussed, Ex. 2 from Table 2 while appeared to provide increased in anti-biofilm activity (fluorescence reading of 269), this Ex. 2 is drawn to using 0.25 wt% glucosamine HCl and 0.75 wt% MEGA-9, which is a formulation outside the scope of the claimed “from 1 wt% to 3 wt% glucosamine, a glucosamine salt, N-acetylglucosamine, or a combination thereof.” Ex.2 uses 0.25 wt% glucosamine HCl, yet claims 13 and 14 require the lower limit amount of glucosamine to be higher at 1 wt%.
In the same context, Ex. 3 form Table 2 while appeared to provide increased in anti-biofilm activity (fluorescence reading of 216), this Ex. 3 is drawn to using 0.75 wt% glucosamine HCl and 0.75 wt% MEGA-9, which is a formulation outside the scope of the claimed “from 1 wt% to 3 wt% glucosamine, a glucosamine salt, N-acetylglucosamine, or a combination thereof.” Ex.3 uses 0.75 wt% glucosamine HCl, yet claims 13 and 14 require the lower limit amount of glucosamine to be higher at 1 wt%.
While Ex. 4 of Table 2 showed the highest increase in anti-biofilm activity (fluorescence reading of 206), said Ex.4 is drawn to using a formulation containing particularly 0.75 wt% MEGA-9 and 2 wt% Glucosamine HCl, the compositions of claims 13 and 14 as discussed above remained broader than the particularly formulation of Ex. 4. There is no predictability if a formulation using a combination of 1 wt% Glucosamine Sulfate or n-acetylglucosamine, and 3 wt% of a surfactant of formula I in which R1 is a hydrogen atom and R3 is an alkyl group having 12 carbon atoms (a composition within the scope of claims 13 and 14) would have behaved in the same manner to achieve increase in anti-biofilm activity to the same extent as Ex. 4. Applicant’s experimental data from the specification lack this showing.
Thus, claims 13 and 14 remain not adequately commensurate in scope with the formulation used in Table 2 for showing the alleged enhanced biofilm disruption effect. In fact, at the bottom of page 31 of the Specification, it was disclosed that the enhanced biofilm disruption effects and in some instance the effect is synergistic when the specific combination of Glucosamine HCl and MEGA-9 is used. However, as discussed above, instant claims 13 and 14 allows for a wider array of combinations and in a variety of concentrations than what is used in Table 2 and thus, it cannot be said by this information whether each of the additional combinations that are not yet supported by data will perform equally better than the combination of 0.75 wt% MEGA-9 and 2 wt% Glucosamine HCl as shown in Ex. 4 of Table 2.
It is noted that MPEP 716.02(d) states: [w]hether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, 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. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980) (Claims were directed to a process for removing corrosion at "elevated temperatures" using a certain ion exchange resin (with the exception of claim 8 which recited a temperature in excess of 100°C). Appellant demonstrated unexpected results via comparative tests with the prior art ion exchange resin at 110°C and 130°C. The court affirmed the rejection of claims 1-7 and 9-10 because the term "elevated temperatures" encompassed temperatures as low as 60°C where the prior art ion exchange resin was known to perform well. The rejection of claim 8, directed to a temperature in excess of 100°C, was reversed.). See also In re Peterson, 315 F.3d 1325, 1329-31, 65 USPQ2d 1379, 1382-85 (Fed. Cir. 2003) (data showing improved alloy strength with the addition of 2% rhenium did not evidence unexpected results for the entire claimed range of about 1-3% rhenium); In re Grasselli, 713 F.2d 731, 741, 218 USPQ 769, 777 (Fed. Cir. 1983) (Claims were directed to certain catalysts containing an alkali metal. Evidence presented to rebut an obviousness rejection compared catalysts containing sodium with the prior art. The court held this evidence insufficient to rebut the prima facie case because experiments limited to sodium were not commensurate in scope with the claims.).
Furthermore, Applicant is additionally reminded that, as previously discussed, even if said claims 13 and 14 were to be amended further so as they are adequately commensurate in scope with the formulation used for showing the alleged enhanced biofilm disruption effect, such amendments may not be sufficient to obviate the pending 103 rejection over Yang ‘445 and Yang ‘230 for the additional reason being that the alleged unexpected results shown in the specification may not be truly unexpected.
To this end, the second issue is that Applicant’s alleged unexpected results shown in the specification are also not persuasive for the reason that the results are not compared to the closest prior art (i.e., Yang ‘230). See MPEP §716.02(e).
In the instant case, it is noted that Yang ‘230 discloses that enhanced biofilm inhibition activity or synergistic effect is provided by using a combination of amino sugar alcohols and derivatives thereof. As such, it appeared that based on the disclosure from Yang ‘230, Applicant’s alleged unexpected results shown in the specification of enhanced biofilm inhibition activity using a combination of amino sugars are not unexpected results, but rather, expected results in view of Yang ‘230, in which Yang ‘230 established that it was the combination of amino sugars that provided the synergistic effect of enhanced biofilm inhibition activity (Yang ‘230: page 8, lines 4-16), just as the claimed invention is encompassing the use of a combination of amino sugars. Accordingly, it is noted that "[e]xpected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967).
As a result, for at least the reasons discussed above and the preponderance of evidence of record, claims 2-5, 7-11 and 13-14 remain rejected as being obvious and unpatentable over the combined teachings of Yang ‘445 and Yang ‘230 in the standing 103 rejection as set forth in this office action.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (US 2010/0130445 A1; hereafter as “Yang ‘445”) in view of Yang et al (WO 2017/205230 A1; hereafter as “Yang ‘230”), as applied to claim 13 above, and further in view of Strand et al (WO 2019/183888 A1; filing date: 29 March 2018).
The method of claim 13 is discussed above, said discussion being incorporated herein in its entirety.
Regarding claim 12, Yang ‘230 teaches the composition is an oral care composition used for inhibiting biofilm formation in the oral cavity, wherein the composition contains arginine and/or glycine (Yang ‘230: Abstract; pages 1-10, 22, and 27; claim 8).
Strand teaches an oral care composition containing arginine, glycine, or combination thereof in an amount from 0.3% to 3% by weight of the composition (Strand: Abstract; pages 3-5, 7-9 and 13-17; claims 1-12).
It would have been obvious to one of ordinary skill in the art to include arginine, glycine, or combination thereof in an amount from 0.3% to 3% by weight in the composition of Yang ‘445, and produce the claimed invention. One of ordinary skill in the art would have been motivated to do so because Yang ‘230 teaches that the oral care composition used for inhibiting biofilm formation in the oral cavity of Yang ‘445 can further contain arginine, glycine, or combination thereof, as this a conventional ingredient normally added to oral care composition, and Strand provide the guidance for including arginine, glycine, or combination thereof in the composition in an amount from 0.3% to 3% by weight. Given the composition of Yang ‘445 is a dental or oral care composition, an ordinary artisan would have looked to including conventional dental ingredients such as arginine, glycine, or combination thereof in an amount from 0.3% to 3% by weight per guidance from Yang ‘230 and Strand, 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 in art the 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 10/27/2025 have been fully considered but they are not persuasive.
Applicant argues:
“[c]laim 12 is dependent upon claim 13. Claim 13 is nonobvious over Yang1 in view of Yang2 for at least the reasons provided above. Strand does not cure the deficiencies. Thus, claim 13 and all claims dependent therefrom, including claim 12, are nonobvious over Yang1 in view of Yang2 and Strand.” (Remarks, page 8).
In response, the Examiner disagrees. As discussed above, claim 13 stands rejected as being obvious and unpatentable over the combined teachings of Yang ‘445 and Yang ‘230, for the reasons discussion on pages 3-5 and 8-13 of this office action, said discussion being incorporated herein in its entirety.
Accordingly, for the reasons discussed above, claim 12 remain rejected as being obvious and unpatentable over Yang '445 in view of Yang '230 and Strand, for the reason of record.
Conclusion
No claim is allowed.
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/DOAN T PHAN/ Primary Examiner, Art Unit 1613