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 .
Claims status
Claim 8 is cancelled.
Claims 1-7 and 9-19 are pending.
Claims 12-17 are withdrawn.
Claims 1-7, 9-11, 18 and 19 are under examination.
Withdrawn rejections
Applicant's arguments filed 6/26/26 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-7, 9-11, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kilpatrick-Liverman et al. (WO2017074964) and O’Connell et al. (US20100196287).
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103, the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103.
Applicant claims:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of an oral care research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from oral care formulations and components, oral pharmaceutical techniques, and chemistry— without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Regarding claims 1, 7, 9, 10 and 18-19, Kilpatrick-Liverman et al. teach in claim 1:
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Kilpatrick-Liverman et al. claim promoting remineralization of dental enamel (Abstract; claims 12-13) because they found that partially hydrolyzed plant proteins are effective in promoting dental remineralization [0006]. Kilpatrick-Liverman et al. show in Table 1 that a composition with 0.2 wt% wheat hydrolysate [0071] had 6.5% remineralization [0078] (15%-8.5% control = 6.5%); 0.5% hydrolyzed wheat protein provides a mean remineralization of 14.58% (Page 22) and 2% hydrolyzed wheat protein provides 18.37% (Table 4; page 24), which the Examiner has portrayed as:
% wheat hydrolysate % remineralization
0.2 6.5
0.5 14.58
2 18.37.
Thus, the amount of hydrolyzed wheat protein is a result effective variable and increasing amounts of hydrolyzed wheat protein provide greater remineralization.
Regarding claim 2, Kilpatrick-Liverman et al. teach that the partially hydrolyzed proteins are from grains of the family Poaceae [0006, 0008, 0010 and 0012].
Regarding claim 3, Kilpatrick-Liverman et al. teach partially hydrolyzed wheat and rice protein (Claim 2).
Regarding claim 4, Kilpatrick-Liverman et al. teach partially hydrolyzed proteins from wheat, rice, almond, potato, soya, pea or combinations thereof [0006, 0010].
Regarding claim 5, Kilpatrick-Liverman et al. teach an effective amount of fluoride (Claim 3).
Regarding claim 6, Kilpatrick-Liverman et al. teach composition without any fluoride source (Table 5, [0056]).
Regarding claims 10-11, Kilpatrick-Liverman et al. teach wherein the composition is in a form selected from a mouth rinse, a toothpaste, a tooth gel, a tooth powder, a non-abrasive gel, a mousse, a foam, a mouth spray, chewing gum, and a tablet, for example dentifrice, e.g., a toothpaste or mouth rinse [0008, 0012, 0028].
Regarding claims 1, 7, 9, 18 and 19, O’Connell et al. teach washing and cleaning compositions (Claim 5) such as a mouth wash that includes additional active ingredients [0130-0134, 0147] such as an active for remineralization [0135] and protein hydrolyzates [0126] such as hydrolyzed wheat protein Gluadin® W40 (Page 11, [0167]). O’Connell et al. teach compositions with 2-28 wt% washing and cleaning active polymers (Claim 8). In the oral and dental care cleaning agent embodiment, in addition to the enzymes (0.1 to 5.0 wt% [0011]), there is 15-35 wt% water and 35-55 wt% of at least one polyhydric alcohol [0147]. The Examiner calculates the low end amount of 0.1 + 15 + 35 = 50.1 wt%, which leaves 49.9 wt% other ingredients, such as remineralization agents/protein hydrolyzates/active polymers to be added.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02) and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
The difference between the instant application and Kilpatrick-Liverman et al. is that Kilpatrick-Liverman et al. do not expressly teach wherein the partially hydrolyzed plant protein is present in the composition in an amount of from 3.05 weight% to 10.5 weight% or from 3.5-10.5 wt% or from 3.05-30.5 wt% or from 3.5-4.5 wt% or from 3.5-5.5 weight % by total weight of the composition. This deficiency in Kilpatrick-Liverman et al. is cured by the teachings of O’Connell et al.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make the oral care composition of Kilpatrick-Liverman et al. wherein the partially hydrolyzed plant protein is present in the composition in an amount of from 3.05 weight% to 10.5 weight% or from 3.5-10.5 wt% or from 3.05-30.5 wt% or from 3.5-4.5 wt% or from 3.5-5.5 wt% by total weight of the composition, as suggested by O’Connell et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to do this because of the following rationale. The test for obviousness is "what the combined teachings of the references would have suggested to those of ordinary skill in the art." In re Keller, 642 F.2d 4I3, 425 (CCPA I98I) (MPEP 2145(III)). In the present case, the combined references render obvious the claimed amounts of hydrolyzed plant protein with a reasonable expectation of success. (See MPEP 2143.02: The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).) Not only is the ordinary artisan aware that partially hydrolyzed plant protein is an active polymer in mouthwash compositions as taught by Kilpatrick-Liverman but also the ordinary artisan is cognizant that oral care compositions such as mouth washes can comprise from at least 2-28% active polymers from the teachings of O’Connell et al., thus overlapping the claimed ranges. See MPEP 2144.05(I): In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Furthermore, the upper value of 3 wt% taught by Kilpatrick-Liverman is nearly the same as the claimed 3.05 wt% and very close to 3.5 wt% such that the ordinary artisan would expect the same properties. See MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where 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 the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” Thus, the claimed ranges are obvious over the prior art range in the absence of any criticality. Secondly, there is: “The normal desire of scientists or artisans to improve upon what is already generally known” In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003). It is already known in the art to have 3 wt% of the partially hydrolyzed plant protein and adding more, as suggested by O’Connell et al., would appear to be obvious absent any criticality or unexpected results. The ordinary artisan is motivated to do so in order to enhance the effectiveness in repairing or mitigating the effects of dental erosion, promoting dental remineralization, and enhancing the anti-cavity effects of fluoride as suggested by Kilpatrick-Liverman et al. [0006-0007], by adding more of the partially hydrolyzed plant proteins with a reasonable expectation of success. Especially when it is known through the teachings of Kilpatrick-Liverman et al. that the amount of partially hydrolyzed plant protein is a result-effective variable and O’Connell et al. teach and suggest an overlapping range of active polymer in the composition.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined 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 at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Response to Arguments:
Applicant’s arguments filed 6/26/2026 have been carefully considered but are not persuasive.
On pages 5-6 of remarks, Applicant respectfully submits there is not sufficient basis to combine these references to reach the present claims, at least not without the use of impermissible hindsight, and that the current rejection is based only a showing that the references could be combined but only with several inferences made along the way. Respectfully, the Examiner does not agree. Applicant has ignored the Examiner’s argument that the 3% taught by Kilpatrick-Liverman is nearly the same as the claimed 3.05 wt% and very close to 3.5 wt% such that the ordinary artisan would expect the same properties. See MPEP 2144.05(I): “Similarly, a prima facie case of obviousness exists where 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 the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985).” Thus, the claimed ranges are obvious over the prior art range in the absence of any criticality. Applicant has failed to show any criticality of the claimed ranges and has failed to address the Examiner’s position. No hindsight was employed to make that determination by the Examiner.
With regard to Applicant’s arguments concerning that the combination of O’Connell with Kilpatrick-Liverman is improper, both references are directed to oral-care compositions, such as mouth wash, and thus analogous art. O’Connell is applied to demonstrate that greater than 3% of protein hydrolysates, which can be construed as washing and cleaning active polymers, are known for washing and cleaning compositions such as mouth wash. Applicant has failed to identify any error in the Examiner’s calculations. Consequently, in view of the combined references, having from 3.05 weight% to 10.5 weight% or from 3.5-10.5 wt% or from 3.05-30.5 wt% or from 3.5-4.5 wt% or from 3.5-5.5 weight % partially hydrolyzed plant protein present in the composition is obvious without more. No criticality of the claimed ranges has been shown by Applicant. As stated previously, at best Applicant asserts that oral care formulations with concentrations above 3 wt% hydrolyzed plant proteins can be both safe and efficacious (Specification [0004]). However, it was already known that 3 wt% is efficacious through the teachings of Kilpatrick-Liverman et al. and the safety concerns appear unknown as admitted by Applicant (Specification [0004]). Consequently, Applicant has not added anything to advance the state of the art. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 298, 127 S.Ct. at 1732 (2007)("Granting patent protection to advances that would occur in the ordinary course without real innovation retards progress. . . .")”. No significant or substantial improvements over the prior art disclosures has been presented by Applicant. Applicant merely used routine research methods to determine that the therapeutic benefit tapers off with increasing concentration by simply performing a routine concentration-response curve (Remarks filed 12/10/2025, pages 7-8). That is just the mechanical skill of the ordinary artisan exercising normal pharmaceutical competence; not inventive ingenuity. Applicant’s findings cannot be considered a significant improvement over the prior art. Applicant’s arguments are not persuasive.
In conclusion, the Examiner has used analogous art and articulated reasoning to reject the claims. Hindsight bias was not employed. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). (MPEP 2145(X)(A)).
Respectfully, the Examiner has carefully considered Applicant’s arguments filed 6/26/2026 and did not find any of them persuasive. Applicant has failed to demonstrate any criticality of the claimed ranges to rebut the Examiner’s position, which is supported by evidence and case law. Accordingly, the claimed ranges of partially hydrolyzed plant protein are obvious in view of the combined references.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERNST V ARNOLD whose telephone number is (571)272-8509. The examiner can normally be reached M-F 7-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Y Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERNST V ARNOLD/Primary Examiner, Art Unit 1613
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